EP3077033A1 - Safety needle assemblies and related methods - Google Patents

Safety needle assemblies and related methods

Info

Publication number
EP3077033A1
EP3077033A1 EP14805955.3A EP14805955A EP3077033A1 EP 3077033 A1 EP3077033 A1 EP 3077033A1 EP 14805955 A EP14805955 A EP 14805955A EP 3077033 A1 EP3077033 A1 EP 3077033A1
Authority
EP
European Patent Office
Prior art keywords
needle
retention
arm
catheter
catheter hub
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP14805955.3A
Other languages
German (de)
French (fr)
Inventor
Teng Sun Teoh
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
B Braun Melsungen AG
Original Assignee
B Braun Melsungen AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by B Braun Melsungen AG filed Critical B Braun Melsungen AG
Publication of EP3077033A1 publication Critical patent/EP3077033A1/en
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0612—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
    • A61M25/0618—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for protecting only the distal tip of the needle, e.g. a needle guard

Definitions

  • the present disclosure generally relates to safety needle assemblies and more particularly to needle tip protector assemblies for use with safety needle assemblies.
  • FIG. 1A is a side cross-sectional view of a catheter assembly including an embodiment of a needle tip protector assembly and a needle assembly;
  • FIG. IB is an enlarged view of the circled portion in FIG. 1A.
  • FIG. 2 is an isometric view of a needle tip protector assembly of FIG. 1 A;
  • FIG. 3 is a sectional view of the needle tip protector assembly of FIG. 2 covering a distal tip of a needle
  • FIG. 4 is a side view of the needle tip protector assembly engaged with the needle of the needle assembly.
  • a needle guard that includes a retention mechanism coaxially disposed with a tip protector.
  • the tip protector can include first and second arms.
  • the retention mechanism is sized and configured to engage an exterior of a catheter hub.
  • the retention mechanism can have two pairs of axially extending cutouts forming first and second spring fingers for gripping the exterior of the catheter hub.
  • the retention mechanism defines a through bore extending through a proximal wall of the retention mechanism between the first and second arms.
  • the retention mechanism can be cylindrical.
  • a tension element can encircle the first and second arms of the tip protector to bias the first arm radially inward.
  • the first arm can be longer than the second arm, and the tip protector can further have a distal tab extending from a distal end of the first arm and overlapping the second arm.
  • An undercut can be defined in the distal tab between the distal tab and the first arm.
  • the tip protector and the retention mechanism can be integrally formed.
  • the through bore of the proximal wall can be sized to retain a change in profile of a needle between the first and second arms.
  • a support can be coupled with the proximal wall and aligned with the through bore to retain a needle tip or change in profile of a needle between the first and second arms.
  • Each pair of axially extending cutouts can be parallel to one another.
  • Each of the spring fingers can have a first retention feature
  • the catheter hub can have a second retention feature
  • the first retention features can removably couple with the second retention feature to removable grip the catheter hub.
  • the first retention features can disengage from the second retention feature when the proximal wall is pressed by a change in profile on a needle, thereby causing the spring fingers to flex outwardly.
  • the first retention features can have retention tabs
  • the second retention feature can have a groove
  • the retention tabs can couple with the groove
  • Another aspect of the present disclosure includes a method of covering a sharp distal tip of a needle of a catheter assembly, with the needle having a change in profile located proximally of the sharp distal tip.
  • the method can include retracting the needle in a proximal direction through a tip protector assembly and a catheter tube attached to a catheter hub.
  • the tip protector assembly can have a proximal wall having a proximal opening, and a sidewall extending distally from the proximal wall and located radially outward of the needle.
  • the method can also include abutting a change in profile of the needle against the proximal opening on the proximal wall, covering the sharp distal tip of the needle with a first arm extending distally from the proximal wall and located radially inward of the sidewall, and detaching the tip protector assembly from the catheter hub by further retracting the needle proximally until an engagement between a retention tab and the catheter hub is released.
  • the retention tab can extend radially inward from the sidewall and between two spaced apart channels that extend from a proximal position to a distal end edge of the sidewall.
  • the first arm can deflect radially outward by the needle against a spring restoring force prior to covering the sharp distal tip.
  • the two spaced apart channels define a first cantilevered spring finger, and a second pair of channels define a second cantilevered spring finger.
  • a retention tab can extend from the first and second cantilevered spring fingers.
  • a second arm can extend distally from the proximal wall, the first arm is longer than the second arm, and a distal tab extends from a distal end of the first arm and overlaps the second arm in a protective position.
  • Yet another aspect of the present disclosure includes a catheter assembly that includes a catheter hub having a catheter tube extending distally from the catheter hub, a needle hub located proximally of the catheter hub having a needle extending distally from the needle hub and through the catheter hub and the catheter tube, the needle including a sharp distal tip and a change in profile located proximally of the sharp distal tip, and a tip protector assembly located on the needle at least in part between the catheter hub and the needle hub.
  • the tip protector assembly can include a proximal wall having an opening for accommodating the needle, a sidewall extending distally from the proximal wall and located radially outward of the needle, at least a first finger extending distally from the proximal wall and located radially inward of the sidewall, wherein the first finger is deflected radially outward by the needle against a spring restoring force, at least a first retention tab extending radially inward from the sidewall and engaging the catheter hub to releasably secure the tip protector assembly to the catheter hub, and first and second channels in the sidewall on either side of the first retention tab.
  • the first and second channels can extend to a distal end edge of the sidewall.
  • the sidewall can have a cantilevered arm between the first and second channels, with the first retention tab being located on the cantilevered arm.
  • a second retention tab can extend radially inward from the sidewall and engage the catheter hub.
  • the first and second retention tabs can be located diametrically opposite one another.
  • the first finger can have a tab portion extending radially inward and bearing against the needle.
  • the second retention tab can be located on a second finger, which is located between two cutouts.
  • a support can support the opening of the proximal wall.
  • FIG. 1A illustrates a catheter assembly 10 incorporating a needle tip protector assembly 12 in its ready position.
  • the catheter assembly 10 includes a flexible tube 14, such as a catheter or catheter tube, extending distally from a catheter hub 16.
  • a needle 18 extends through the catheter hub 16 and the flexible tube 14.
  • the needle 18, which includes a sharp distal tip 20, extends distally from a needle hub 22 and out a distal end of the flexible tube 14 in the ready position.
  • the needle tip protector assembly 12 is slidably arranged on the needle 18 at a location at least in part between the needle hub 22 and the catheter hub 16.
  • the needle hub 22 and needle 18 form a needle assembly.
  • the needle assembly is usable with the needle tip protector assembly 12 without the catheter hub and catheter tube, such as for an injection needle.
  • the needle 18 can have any size and shape and can be used for any medical application, such as for piercing the skin and delivering a distal tip of the catheter into a venous cavity of the patient.
  • the flexible tube 14 and catheter hub 16 provide a fluid pathway to facilitate delivery of fluids into and/or retrieval of fluids from within the patient.
  • the needle and needle hub are removed from the catheter tube and catheter hub following successful venipuncture.
  • the flexible tube 14 and the catheter hub 16 generally each comprise biocompatible materials that are also compatible with fluids and medicaments commonly used in infusion procedures.
  • the catheter hub 16 may be configured for use with intravenous tubing to facilitate delivery of fluids into or removal of fluids from the patient.
  • the proximal end 23 of the catheter hub 16 may include a female luer connector (not shown) having a female luer taper and/or female luer lock threads.
  • the female luer connector is configured to matingly receive a male luer connector, such as used in connection with an IV line, a luer access connector, a needle hub, a vent plug, or another known or future-developed IV device using a luer fitting.
  • a male luer connector such as used in connection with an IV line, a luer access connector, a needle hub, a vent plug, or another known or future-developed IV device using a luer fitting.
  • Each of these components can be sized and configured in conformity with at least some of the International Standards Organization (ISO) standards for female and male luer connections under current or future standards.
  • ISO International Standards Organization
  • the catheter assembly 10 can further include a valve 58 housed within the catheter hub 16 and penetrated by the needle 18.
  • the valve 58 can be a septum.
  • the valve 58 can include one or more slits (not shown) through which the needle 18 extends.
  • the valve 58 forms a seal around the needle 18 when not activated.
  • the slits from the valve close such that the valve 58 seals upon itself to restrict or limit fluid flow thereacross. The valve 58 thus restricts back bleed through the catheter hub 16.
  • the valve 58 can be made of a material that forms a seal at the interface with the needle 18 and that reseals upon itself after the needle 18 is withdrawn.
  • the valve 58 may comprise silicone, silicone rubber, polypropylene, or other suitable materials.
  • the valve 58 may have three slits converging at a single central point, similar to a three-point star. In other examples, more or less slits may be incorporated.
  • the valve 58 may embody a valve disc with or without a skirt or side section. Any number of means may be employed to retain the valve within the interior cavity of the catheter hub, including using a two-part catheter hub body and wedging part of the valve along a seam of the two-part body.
  • the catheter assembly can further include a valve opener 53.
  • the valve opener 53 is configured to press against the valve 58 and open the valve 58, such as to force the flaps of the slits to open, to allow fluid or solution to pass distally through the catheter hub 16 and the catheter tube 14.
  • the valve opener 53 can be advanced distally by a male medical implement, such as a syringe tip, which presses against the proximal end of the valve opener 53 to push a nose section 57 of the valve opener 53 distally forward into the valve to open, such as by opening one or more slits.
  • the valve opener 53 has a wedge shaped nose section 57 to press open the valve 58 and an extension or leg 59 extending from the nose section 57 to be pushed against by a male medical implement.
  • a single extension or leg 59 is usable to push the valve opener 53, two or more extensions 59 are preferred.
  • the extension 59 can be one or more separate sections that can be pressed against by a male medical implement to advance the valve opener 57 against the valve 58.
  • the valve opener 57 has an opening 60 defined through a center of the nose section 57 of the valve opener 57 for the needle 18 to pass therethrough and as a fluid passage for fluid flow.
  • the needle tip protector assembly 12 includes a retention mechanism comprising a first retention feature 24 that engages a second retention feature 26 on an outer surface 28 of the catheter hub 16.
  • the second retention feature 26 can be at a proximal location of the catheter hub 16.
  • the first retention feature 24 comprises a pair of oppositely disposed and spaced apart retention tabs 30 that extend toward one another from an inner surface 32 of a sidewall 34 of the needle tip protector assembly 12, at a distal end 36 thereof.
  • the retention mechanism defines a through bore 48 extending through a proximal wall 46 of the retention mechanism between the first and second arms 50, 52.
  • the second retention feature 26 comprises a pair of tabs oppositely disposed on the catheter hub.
  • the second retention feature 26 can comprise retention depressions, recesses, or grooves 38 formed on the outer surface 28 of the catheter hub 16.
  • the second retention feature 26 may comprise a continuous annular groove or recess that extends around the circumference of the outer surface 28 of the catheter hub 16.
  • the first retention feature 24 can project into the annular recess of the second retention feature 26 to removably retain the needle tip protector assembly 12 to the catheter hub 16 in the ready position and during retraction of the needle away from the catheter tube and catheter hub following successful venipuncture.
  • the two retention features 24, 26 are configured to separate.
  • the first and second retention features 24, 26 can be any other coupling means to removably secure the need tip protector assembly 12 to the catheter hub 16.
  • the needle tip protector assembly 12 further includes a proximal wall 46 having a through bore 48 with a proximal opening for receiving the needle 18.
  • the first arm 50 and second arm 52 of the needle tip protector assembly 12 extend distally from a central area of the proximal wall 46.
  • the first arm 50 is longer than the second arm 52 and includes a distal tab 54 that extends toward the second arm 52 and substantially overlaps a distal end portion of the second arm 52.
  • the distal tab 54 preferably includes an undercut for catching the needle tip 20 as the needle 18 is withdrawn from the catheter assembly 10. In the ready position shown in FIG. 1A, the distal tab 54 of the first arm 50 is supported on the needle 18 against a spring restoring force of the deflected first arm 50.
  • the needle tip protector assembly 12 can further include a tension element or member 56, such as a resilient band or a garter spring, encircling the first and second arms 50, 52, to generate additional biasing force to force the first arm 50 and the second arm 52 radially inward.
  • the tension element 56 can also prevent the needle 18 from moving out between the first and second arms 50, 52, such as swaying laterally, thereby maintaining the needle 18 inside and between the first and second arms 50, 52.
  • the needle tip protector assembly 12 can also include a washer or backup support 55 (FIG. 3) aligned with the through bore 48 of the proximal wall 46.
  • the washer 55 can be integrated in the proximal wall 46 or fixed to a surface of the proximal wall on either side of the proximal wall 46, i.e., on the distally facing wall surface or the proximally facing wall surface.
  • the washer 55 is configured to increase the pulling force or detachment force required to pull a change in profile 19 on the needle 18 completely through the bore 48 during use.
  • a sleeve is molded into the proximal wall, which can be viewed as a washer with an extended or elongated body. The sleeve can be configured to prevent the change in profile 19 from pulling through the proximal wall.
  • the needle tip protector assembly 12 further includes two oppositely disposed pairs of channels or cutouts 40.
  • the retention tabs 30 are each located between a pair of channels 40 and each channel 40 extends from near a proximal end 42 of the sidewall 34 through the distal end edge 37 of the sidewall 34. Portions of the sidewall 34 between each pair of channels thus define cantilevered spring fingers 44.
  • the retention tabs 30 extend radially inward at the distal ends 36 of the spring fingers 44.
  • the spring fingers 44 are configured to deflect radially outward to disengage the retention tabs 30 from the retention depressions, recesses, or grooves 38 to disengage the needle tip protector assembly 12 from the catheter hub 16.
  • the length of the channels 40 and the thickness of the spring fingers 44 can be selected to control the biasing or resiliency of the two spring fingers 44.
  • the needle tip protector assembly 12 covers the needle tip 20 after placement of the flexible tube 14 in and withdrawal of the needle 18 from the patient's vasculature.
  • the needle 18 moves relative to the needle tip protector assembly 12, which is secured to the catheter hub 16 through the engagement of the first and second retention features 52, 54.
  • the spring restoring force in the first arm 50 returns the first arm 50 to its unstressed position in which the distal tab 54 extends across the longitudinal axis of the needle 18 and covers the needle tip 20.
  • the change in profile 19 of the needle 18 near the distal tip 20 engages the proximal wall 46 of the needle tip protector assembly 12.
  • the change in profile 19 is sized such that it cannot be pulled through the bore 48 in the proximal wall 46.
  • the change in profile 19 can be a crimp, bulge, enlargement, or any change in profile of the needle 18.
  • the change in profile 19 bears against the proximal wall 46, thereby creating a tension force between the needle tip protector assembly 12 and the catheter hub 16.
  • the tension force causes the spring fingers 44 to flex outwardly, thereby disengaging the retention tabs 30 from the retention depressions, recesses, or grooves 38, and disconnecting the needle tip protector assembly 12 from the catheter hub 16.
  • the needle tip protector assembly 12 remains in the position shown in FIG. 3 in which the distal tip 20 is safely covered, which may also be referred to as a protective position of the tip protector assembly.
  • Axial movement of the needle 18 relative to the needle tip protector assembly 12 is now limited, as the distal tab 54 of the first arm 50 blocks the needle tip 20 and the engagement of the change in profile 19 with the proximal wall 46 prevents the needle tip 20 from being pulled through the bore 48.

Abstract

A needle guard having a retention mechanism coaxially disposed with a tip protector. The tip protector has first(50) and second (52) arms. The retention mechanism is sized and configured to engage a catheter hub (16). The retention mechanism has two pairs of cutouts forming first and second spring fingers (44) for gripping the catheter hub. The retention mechanism defines a through bore (48) extending through a proximal wall of the retention mechanism between the first and second arms.

Description

SAFETY NEEDLE ASSEMBLIES AND RELATED METHODS
FIELD OF ART
The present disclosure generally relates to safety needle assemblies and more particularly to needle tip protector assemblies for use with safety needle assemblies.
BRIEF DESCRIPTION OF THE DRAWINGS
The various embodiments of the present safety needle assemblies and related methods now will be discussed in detail with an emphasis on highlighting the advantageous features. These embodiments depict the novel and non-obvious safety needle assemblies shown in the accompanying drawings, which are for illustrative purposes only. These drawings include the following figures, in which like numerals indicate like parts:
FIG. 1A is a side cross-sectional view of a catheter assembly including an embodiment of a needle tip protector assembly and a needle assembly;
FIG. IB is an enlarged view of the circled portion in FIG. 1A.
FIG. 2 is an isometric view of a needle tip protector assembly of FIG. 1 A;
FIG. 3 is a sectional view of the needle tip protector assembly of FIG. 2 covering a distal tip of a needle; and
FIG. 4 is a side view of the needle tip protector assembly engaged with the needle of the needle assembly.
SUMMARY
The various embodiments of a needle safety assembly have several features, no single one of which is solely responsible for their desirable attributes. Without limiting the scope of the present embodiments as set forth in the claims that follow, their more prominent features now will be discussed briefly.
Aspects of the present disclosure include a needle guard that includes a retention mechanism coaxially disposed with a tip protector. The tip protector can include first and second arms. The retention mechanism is sized and configured to engage an exterior of a catheter hub. The retention mechanism can have two pairs of axially extending cutouts forming first and second spring fingers for gripping the exterior of the catheter hub. The retention mechanism defines a through bore extending through a proximal wall of the retention mechanism between the first and second arms. The retention mechanism can be cylindrical.
A tension element can encircle the first and second arms of the tip protector to bias the first arm radially inward.
The first arm can be longer than the second arm, and the tip protector can further have a distal tab extending from a distal end of the first arm and overlapping the second arm.
An undercut can be defined in the distal tab between the distal tab and the first arm.
The tip protector and the retention mechanism can be integrally formed.
The through bore of the proximal wall can be sized to retain a change in profile of a needle between the first and second arms.
A support can be coupled with the proximal wall and aligned with the through bore to retain a needle tip or change in profile of a needle between the first and second arms.
Each pair of axially extending cutouts can be parallel to one another.
Each of the spring fingers can have a first retention feature, the catheter hub can have a second retention feature, and the first retention features can removably couple with the second retention feature to removable grip the catheter hub.
The first retention features can disengage from the second retention feature when the proximal wall is pressed by a change in profile on a needle, thereby causing the spring fingers to flex outwardly.
The first retention features can have retention tabs, the second retention feature can have a groove, and the retention tabs can couple with the groove.
Another aspect of the present disclosure includes a method of covering a sharp distal tip of a needle of a catheter assembly, with the needle having a change in profile located proximally of the sharp distal tip. The method can include retracting the needle in a proximal direction through a tip protector assembly and a catheter tube attached to a catheter hub. The tip protector assembly can have a proximal wall having a proximal opening, and a sidewall extending distally from the proximal wall and located radially outward of the needle.
The method can also include abutting a change in profile of the needle against the proximal opening on the proximal wall, covering the sharp distal tip of the needle with a first arm extending distally from the proximal wall and located radially inward of the sidewall, and detaching the tip protector assembly from the catheter hub by further retracting the needle proximally until an engagement between a retention tab and the catheter hub is released. The retention tab can extend radially inward from the sidewall and between two spaced apart channels that extend from a proximal position to a distal end edge of the sidewall.
The first arm can deflect radially outward by the needle against a spring restoring force prior to covering the sharp distal tip. The two spaced apart channels define a first cantilevered spring finger, and a second pair of channels define a second cantilevered spring finger. A retention tab can extend from the first and second cantilevered spring fingers.
A second arm can extend distally from the proximal wall, the first arm is longer than the second arm, and a distal tab extends from a distal end of the first arm and overlaps the second arm in a protective position.
Yet another aspect of the present disclosure includes a catheter assembly that includes a catheter hub having a catheter tube extending distally from the catheter hub, a needle hub located proximally of the catheter hub having a needle extending distally from the needle hub and through the catheter hub and the catheter tube, the needle including a sharp distal tip and a change in profile located proximally of the sharp distal tip, and a tip protector assembly located on the needle at least in part between the catheter hub and the needle hub.
The tip protector assembly can include a proximal wall having an opening for accommodating the needle, a sidewall extending distally from the proximal wall and located radially outward of the needle, at least a first finger extending distally from the proximal wall and located radially inward of the sidewall, wherein the first finger is deflected radially outward by the needle against a spring restoring force, at least a first retention tab extending radially inward from the sidewall and engaging the catheter hub to releasably secure the tip protector assembly to the catheter hub, and first and second channels in the sidewall on either side of the first retention tab.
The first and second channels can extend to a distal end edge of the sidewall. The sidewall can have a cantilevered arm between the first and second channels, with the first retention tab being located on the cantilevered arm.
A second retention tab can extend radially inward from the sidewall and engage the catheter hub. The first and second retention tabs can be located diametrically opposite one another. The first finger can have a tab portion extending radially inward and bearing against the needle. The second retention tab can be located on a second finger, which is located between two cutouts. A support can support the opening of the proximal wall.
DETAILED DESCRIPTION
The following detailed description describes the present embodiments with reference to the drawings. In the drawings, reference numbers label elements of the present embodiments. These reference numbers are reproduced below in connection with the discussion of the corresponding drawing features.
FIG. 1A illustrates a catheter assembly 10 incorporating a needle tip protector assembly 12 in its ready position. The catheter assembly 10 includes a flexible tube 14, such as a catheter or catheter tube, extending distally from a catheter hub 16. A needle 18 extends through the catheter hub 16 and the flexible tube 14. The needle 18, which includes a sharp distal tip 20, extends distally from a needle hub 22 and out a distal end of the flexible tube 14 in the ready position. The needle tip protector assembly 12 is slidably arranged on the needle 18 at a location at least in part between the needle hub 22 and the catheter hub 16.
The needle hub 22 and needle 18 form a needle assembly. In some examples, the needle assembly is usable with the needle tip protector assembly 12 without the catheter hub and catheter tube, such as for an injection needle. The needle 18 can have any size and shape and can be used for any medical application, such as for piercing the skin and delivering a distal tip of the catheter into a venous cavity of the patient. Once inserted into the patient, the flexible tube 14 and catheter hub 16 provide a fluid pathway to facilitate delivery of fluids into and/or retrieval of fluids from within the patient. The needle and needle hub are removed from the catheter tube and catheter hub following successful venipuncture. Thus, the flexible tube 14 and the catheter hub 16 generally each comprise biocompatible materials that are also compatible with fluids and medicaments commonly used in infusion procedures. Additionally, the catheter hub 16 may be configured for use with intravenous tubing to facilitate delivery of fluids into or removal of fluids from the patient.
The proximal end 23 of the catheter hub 16 may include a female luer connector (not shown) having a female luer taper and/or female luer lock threads. The female luer connector is configured to matingly receive a male luer connector, such as used in connection with an IV line, a luer access connector, a needle hub, a vent plug, or another known or future-developed IV device using a luer fitting. Each of these components can be sized and configured in conformity with at least some of the International Standards Organization (ISO) standards for female and male luer connections under current or future standards.
The catheter assembly 10 can further include a valve 58 housed within the catheter hub 16 and penetrated by the needle 18. In another embodiment, the valve 58 can be a septum. The valve 58 can include one or more slits (not shown) through which the needle 18 extends. The valve 58 forms a seal around the needle 18 when not activated. When the needle 18 is withdrawn from the catheter assembly 10 after placement of the flexible tube 14 in the patient's vasculature, the slits from the valve close such that the valve 58 seals upon itself to restrict or limit fluid flow thereacross. The valve 58 thus restricts back bleed through the catheter hub 16. The valve 58 can be made of a material that forms a seal at the interface with the needle 18 and that reseals upon itself after the needle 18 is withdrawn. For example, and without limitation, the valve 58 may comprise silicone, silicone rubber, polypropylene, or other suitable materials. The valve 58 may have three slits converging at a single central point, similar to a three-point star. In other examples, more or less slits may be incorporated. The valve 58 may embody a valve disc with or without a skirt or side section. Any number of means may be employed to retain the valve within the interior cavity of the catheter hub, including using a two-part catheter hub body and wedging part of the valve along a seam of the two-part body.
The catheter assembly can further include a valve opener 53. The valve opener 53 is configured to press against the valve 58 and open the valve 58, such as to force the flaps of the slits to open, to allow fluid or solution to pass distally through the catheter hub 16 and the catheter tube 14. For example, the valve opener 53 can be advanced distally by a male medical implement, such as a syringe tip, which presses against the proximal end of the valve opener 53 to push a nose section 57 of the valve opener 53 distally forward into the valve to open, such as by opening one or more slits. In one example, the valve opener 53 has a wedge shaped nose section 57 to press open the valve 58 and an extension or leg 59 extending from the nose section 57 to be pushed against by a male medical implement. Although a single extension or leg 59 is usable to push the valve opener 53, two or more extensions 59 are preferred. The extension 59 can be one or more separate sections that can be pressed against by a male medical implement to advance the valve opener 57 against the valve 58. The valve opener 57 has an opening 60 defined through a center of the nose section 57 of the valve opener 57 for the needle 18 to pass therethrough and as a fluid passage for fluid flow.
The needle tip protector assembly 12 includes a retention mechanism comprising a first retention feature 24 that engages a second retention feature 26 on an outer surface 28 of the catheter hub 16. The second retention feature 26 can be at a proximal location of the catheter hub 16. In the illustrated embodiment, the first retention feature 24 comprises a pair of oppositely disposed and spaced apart retention tabs 30 that extend toward one another from an inner surface 32 of a sidewall 34 of the needle tip protector assembly 12, at a distal end 36 thereof. The retention mechanism defines a through bore 48 extending through a proximal wall 46 of the retention mechanism between the first and second arms 50, 52. Referring also to FIG. IB, the second retention feature 26 comprises a pair of tabs oppositely disposed on the catheter hub. In other examples, the second retention feature 26 can comprise retention depressions, recesses, or grooves 38 formed on the outer surface 28 of the catheter hub 16. In certain embodiments, the second retention feature 26 may comprise a continuous annular groove or recess that extends around the circumference of the outer surface 28 of the catheter hub 16. The first retention feature 24 can project into the annular recess of the second retention feature 26 to removably retain the needle tip protector assembly 12 to the catheter hub 16 in the ready position and during retraction of the needle away from the catheter tube and catheter hub following successful venipuncture. As further discussed below, the two retention features 24, 26 are configured to separate. The first and second retention features 24, 26 can be any other coupling means to removably secure the need tip protector assembly 12 to the catheter hub 16.
The needle tip protector assembly 12 further includes a proximal wall 46 having a through bore 48 with a proximal opening for receiving the needle 18. The first arm 50 and second arm 52 of the needle tip protector assembly 12 extend distally from a central area of the proximal wall 46. The first arm 50 is longer than the second arm 52 and includes a distal tab 54 that extends toward the second arm 52 and substantially overlaps a distal end portion of the second arm 52. The distal tab 54 preferably includes an undercut for catching the needle tip 20 as the needle 18 is withdrawn from the catheter assembly 10. In the ready position shown in FIG. 1A, the distal tab 54 of the first arm 50 is supported on the needle 18 against a spring restoring force of the deflected first arm 50. Said differently, the distal tab 54 is resilient and is biased radially outwardly by a side of the needle shaft. The needle tip protector assembly 12 can further include a tension element or member 56, such as a resilient band or a garter spring, encircling the first and second arms 50, 52, to generate additional biasing force to force the first arm 50 and the second arm 52 radially inward. The tension element 56 can also prevent the needle 18 from moving out between the first and second arms 50, 52, such as swaying laterally, thereby maintaining the needle 18 inside and between the first and second arms 50, 52.
The needle tip protector assembly 12 can also include a washer or backup support 55 (FIG. 3) aligned with the through bore 48 of the proximal wall 46. The washer 55 can be integrated in the proximal wall 46 or fixed to a surface of the proximal wall on either side of the proximal wall 46, i.e., on the distally facing wall surface or the proximally facing wall surface. The washer 55 is configured to increase the pulling force or detachment force required to pull a change in profile 19 on the needle 18 completely through the bore 48 during use. In another example, a sleeve is molded into the proximal wall, which can be viewed as a washer with an extended or elongated body. The sleeve can be configured to prevent the change in profile 19 from pulling through the proximal wall.
With reference now to FIG. 2, the needle tip protector assembly 12 further includes two oppositely disposed pairs of channels or cutouts 40. The retention tabs 30 are each located between a pair of channels 40 and each channel 40 extends from near a proximal end 42 of the sidewall 34 through the distal end edge 37 of the sidewall 34. Portions of the sidewall 34 between each pair of channels thus define cantilevered spring fingers 44. The retention tabs 30 extend radially inward at the distal ends 36 of the spring fingers 44. The spring fingers 44 are configured to deflect radially outward to disengage the retention tabs 30 from the retention depressions, recesses, or grooves 38 to disengage the needle tip protector assembly 12 from the catheter hub 16. The length of the channels 40 and the thickness of the spring fingers 44 can be selected to control the biasing or resiliency of the two spring fingers 44.
With reference to FIG. 3 and FIG. 4, the needle tip protector assembly 12 covers the needle tip 20 after placement of the flexible tube 14 in and withdrawal of the needle 18 from the patient's vasculature. When the needle 18 is withdrawn from the flexible tube 14 and the catheter hub 16, the needle 18 moves relative to the needle tip protector assembly 12, which is secured to the catheter hub 16 through the engagement of the first and second retention features 52, 54. As the needle tip 20 moves proximally of the distal tab 54 of the first arm 50, the spring restoring force in the first arm 50 returns the first arm 50 to its unstressed position in which the distal tab 54 extends across the longitudinal axis of the needle 18 and covers the needle tip 20.
Subsequently with further proximal movement of the needle 18, the change in profile 19 of the needle 18 near the distal tip 20 engages the proximal wall 46 of the needle tip protector assembly 12. The change in profile 19 is sized such that it cannot be pulled through the bore 48 in the proximal wall 46. The change in profile 19 can be a crimp, bulge, enlargement, or any change in profile of the needle 18. Thus, as the needle 18 is further withdrawn, the change in profile 19 bears against the proximal wall 46, thereby creating a tension force between the needle tip protector assembly 12 and the catheter hub 16. The tension force causes the spring fingers 44 to flex outwardly, thereby disengaging the retention tabs 30 from the retention depressions, recesses, or grooves 38, and disconnecting the needle tip protector assembly 12 from the catheter hub 16. The needle tip protector assembly 12 remains in the position shown in FIG. 3 in which the distal tip 20 is safely covered, which may also be referred to as a protective position of the tip protector assembly. Axial movement of the needle 18 relative to the needle tip protector assembly 12 is now limited, as the distal tab 54 of the first arm 50 blocks the needle tip 20 and the engagement of the change in profile 19 with the proximal wall 46 prevents the needle tip 20 from being pulled through the bore 48.
The above description presents various embodiments of the present invention, and the manner and process of making and using them, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains to make and use this invention. This invention is, however, susceptible to modifications and alternate constructions from that discussed above that are fully equivalent. Consequently, this invention is not limited to the particular embodiments disclosed. On the contrary, this invention covers all modifications and alternate constructions coming within the spirit and scope of the invention as generally expressed by the following claims, which particularly point out and distinctly claim the subject matter of the invention.

Claims

WHAT IS CLAIMED IS:
1. A needle guard, comprising:
a retention mechanism coaxially disposed with a tip protector, the tip protector including first and second arms, the retention mechanism being sized and configured to engage an exterior of a catheter hub, the retention mechanism having two pairs of axially extending cutouts forming first and second spring fingers for gripping the exterior of the catheter hub, and the retention mechanism defining a through bore extending through a proximal wall of the retention mechanism between the first and second arms.
2. The needle guard of claim 1, wherein the retention mechanism is cylindrical.
3. The needle guard of claim 1, further comprising a tension element encircling the first and second arms of the tip protector to bias the first arm radially inward.
4. The needle guard of claim 1 , wherein the first arm is longer than the second arm, and the tip protector further comprises a distal tab extending from a distal end of the first arm and overlaps the second arm.
5. The needle guard of claim 4, wherein an undercut is defined in the distal tab between the distal tab and the first arm.
6. The needle guard of claim 1, wherein the tip protector and the retention mechanism are integrally formed.
7. The needle guard of claim 1, wherein the through bore of the proximal wall is sized to retain a change in profile of a needle between the first and second arms.
8. The needle guard of claim 1, further comprising a support coupled with the proximal wall and aligned with the through bore to retain a change in profile of a needle between the first and second arms.
9. The needle guard of claim 1, wherein each pair of axially extending cutouts are parallel to one another.
10. The needle guard of claim 1, wherein each of the spring fingers has a first retention feature, the catheter hub has a second retention feature, the first retention features removably couple with the second retention feature to removable grip the catheter hub.
11. The needle guard of claim 10, the first retention features disengage from the second retention feature when the proximal wall is pressed by a change in profile on a needle, thereby causing the spring fingers to flex outwardly.
12. The needle guard of claim 10, wherein the first retention features comprise retention tabs, the second retention feature comprises a groove, and the retention tabs couple with the groove.
13. A method of covering a sharp distal tip of a needle of a catheter assembly, the needle having a change in profile located proximally of the sharp distal tip, the method comprising:
retracting the needle in a proximal direction through a tip protector assembly and a catheter tube attached to a catheter hub, the tip protector assembly comprising a proximal wall having a proximal opening and a sidewall extending distally from the proximal wall and located radially outward of the needle;
abutting the change in profile of the needle against the proximal opening on the proximal wall;
covering the sharp distal tip of the needle with a first arm extending distally from the proximal wall and located radially inward of the sidewall; and
detaching the tip protector assembly from the catheter hub by further retracting the needle proximally until an engagement between a retention tab and the catheter hub is released, the retention tab extending radially inward from the sidewall and between two spaced apart channels that extend from a proximal position to a distal end edge of the sidewall.
14. The method of claim 13, wherein the first arm is deflected radially outward by the needle against a spring restoring force prior to covering the sharp distal tip.
15. The method of claim 13, wherein the two spaced apart channels define a first cantilevered spring finger and wherein the tip protector assembly further comprises a second pair of channels defining a second cantilevered spring finger.
16. The method of claim 13, wherein a second arm extends distally from the proximal wall, the first arm is longer than the second arm, and a distal tab extends from a distal end of the first arm and overlaps the second arm in a protective position.
17. A catheter assembly, comprising:
a catheter hub having a catheter tube extending distally from the catheter hub; a needle hub located proximally of the catheter hub having a needle extending distally from the needle hub and through the catheter hub and the catheter tube, the needle including a sharp distal tip and a change in profile located proximally of the sharp distal tip; and
a tip protector assembly located on the needle at least in part between the catheter hub and the needle hub, the tip protector assembly including:
a proximal wall including an opening for accommodating the needle; a sidewall extending distally from the proximal wall and located radially outward of the needle;
at least a first finger extending distally from the proximal wall and located radially inward of the sidewall, wherein the first finger is deflected radially outward by the needle against a spring restoring force;
at least a first retention tab extending radially inward from the sidewall and engaging the catheter hub to releasably secure the tip protector assembly to the catheter hub; and
first and second channels in the sidewall on either side of the first retention tab.
18. The catheter assembly of claim 17, wherein the first and second channels extend to a distal end edge of the sidewall.
19. The catheter assembly of Claim 18, wherein the sidewall includes a cantilevered arm between the first and second channels, the first retention tab being located on the cantilevered arm.
20. The catheter assembly of Claim 17, wherein the tip protector assembly further comprises a second retention tab extending radially inward from the sidewall and engaging the catheter hub.
21. The catheter assembly of Claim 20, wherein the first and second retention tabs are located diametrically opposite one another.
22. The catheter assembly of Claim 17, wherein the first finger includes a tab portion that extends radially inward and bears against the needle.
23. The catheter assembly of Claim 20, wherein the second retention tab is located on a second finger, which is located between two cutouts.
24. The catheter assembly of Claim 17, further comprising a support supporting the opening of the proximal wall.
EP14805955.3A 2013-12-05 2014-12-03 Safety needle assemblies and related methods Withdrawn EP3077033A1 (en)

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PCT/EP2014/076452 WO2015082559A1 (en) 2013-12-05 2014-12-03 Safety needle assemblies and related methods

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US20150238733A1 (en) * 2014-02-25 2015-08-27 Mohamad Yasin bin Abdulla Catheter devices and related methods
US10507281B2 (en) * 2016-03-28 2019-12-17 Becton, Dickinson And Company Cannula capture mechanism
CN108744146B (en) * 2018-07-04 2023-09-19 江苏苏云医疗器材有限公司 Needle-stick-preventing remaining needle
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AU2014359265A1 (en) 2016-06-16
AU2014359265B2 (en) 2019-06-13

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