US20230201483A1 - Safety needle device - Google Patents
Safety needle device Download PDFInfo
- Publication number
- US20230201483A1 US20230201483A1 US18/097,368 US202318097368A US2023201483A1 US 20230201483 A1 US20230201483 A1 US 20230201483A1 US 202318097368 A US202318097368 A US 202318097368A US 2023201483 A1 US2023201483 A1 US 2023201483A1
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- US
- United States
- Prior art keywords
- retractable sheath
- housing
- guide path
- needle device
- safety needle
- 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.)
- Pending
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- 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
- A61M5/321—Means for protection against accidental injuries by used needles
- A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
- A61M5/3271—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel with guiding tracks for controlled sliding of needle protective sleeve from needle exposing to needle covering position
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- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
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- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
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- A61M25/0606—"Over-the-needle" catheter assemblies, e.g. I.V. catheters
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- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
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- 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
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- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
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- A61M25/0625—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 with a permanent connection to the needle hub, e.g. a guiding rail, a locking mechanism or a guard advancement mechanism
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- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
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- A61M5/326—Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
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- A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
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- A61M5/3271—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel with guiding tracks for controlled sliding of needle protective sleeve from needle exposing to needle covering position
- A61M5/3272—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel with guiding tracks for controlled sliding of needle protective sleeve from needle exposing to needle covering position having projections following labyrinth paths
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Definitions
- the present disclosure relates generally to a safety needle device, and more particularly to a single-use passive safety needle device having a housing, a first guide path, a second guide path, a third guide path intersecting the first guide path and the second guide path, a needle hub, a needle cannula, a retractable sheath, a first locking member, a second locking member, a rotating cam, and a spring to bias the retractable sheath in a distal direction to cover the distal end of the needle cannula.
- Needle devices are used throughout the medical industry for the injection and withdrawal of a wide variety of fluids and solutions into and from the human body. Because of the numerous potential hazards associated with the handling and manipulation of bodily fluids, and particularly blood, there are a number of known safety features that are frequently incorporated into various types of needle devices to protect the practitioner from accidental exposure to the needle.
- Prior safety needle devices include several disadvantages including having a retractable sheath requiring long stroke distances to activate the safety feature, multi-component retraction and locking elements, and conveying an undesirable significant force against a patient's skin during activation of the safety feature upon receiving an injection.
- Conventional retraction syringe assemblies often also do not incorporate reuse prevention features, and thus, the retraction mechanism of the syringe may be reset so the syringe barrel may be reused. The reuse of syringe assemblies without sterilization or sufficient sterilization is believed to facilitate the transfer of contagious diseases.
- the retraction features of conventional syringes may also require the user to actively activate the retraction mechanism. Accordingly, the chance of human error in failure to activate or properly activate the retraction mechanism can lead to continued exposure of needles leading to needle stick injuries.
- Some known retracting sheath safety needle devices have been developed to include a single-use safety needle device assembly that obscures a substantial majority or an entirety of an injection needle from view before, during, and after an injection procedure.
- many injection procedures require that the practitioner know precisely the location and depth to which the needle is inserted in the patient's tissue to be sure that medication is delivered to an appropriate location.
- a safety needle device including a housing configured to couple to a syringe, the housing having a proximal end, a distal end, and a housing body.
- the safety needle device also includes a first guide path, a second guide path and a third guide path disposed on the housing body, the second guide path intersecting the first guide path and the third guide path.
- the one or more guide paths may be straight paths, and one or more guide paths may be helical.
- the two guide paths may be straight paths, and one guide paths may be helical.
- the first and third guide paths may be straight paths, and the second guide path may be helical.
- a needle hub is disposed on the proximal end of the housing with a needle cannula attached to the needle hub.
- the safety needle device may also include a retractable sheath having a guide element configured to move between an initial position, a retracted position and an extended position with respect to the housing, wherein the initial position partially exposes a distal tip of the needle cannula, the retracted position fully exposes the needle cannula, and the extended position fully covers the distal tip of the needle cannula.
- the first guide path and the second guide path are disposed on the housing body configured to receive the guide element.
- the safety needle device also includes a first locking member, a second locking member; a rotating cam disposed in the housing body and connected to the retractable sheath; and a spring element.
- the safety needle device is a single use device.
- the safety needle device is a passively activated device in which the safety features provide post-injection needle shielding without additional intervention by the user.
- the first locking member may comprise a tab on a distal end of the retractable sheath and a locking rib on the housing. In one or more embodiments, the first locking member may comprise a locking rib on a distal end of the retractable sheath and a tab on the housing. Movement of the retractable sheath from the initial position to the retracted position may engage the locking rib of the housing to the tab on the distal end of the retractable sheath. The retractable sheath may rotate with respect to the housing during movement from the initial position to the retracted position.
- Rotation of the retractable sheath from the initial position to the retracted position may transfer the guide element of the retractable sheath from the first guide path on the housing to the third guide path on the housing via the second guide path.
- the guide element may be a peg.
- the retractable sheath translates from the initial position to the retracted position without impediment.
- movement of the retractable sheath from the retracted position to the extended position may engage the second locking member to a distal tip of the needle cannula.
- the second locking member may be a metal latch.
- the first locking member may inhibit reuse of the device by inhibiting rotation of the retractable sheath.
- the second locking member may inhibit reuse of the device by inhibiting translation of the retractable sheath.
- the spring element biases the retractable sheath toward the extended position.
- the needle cannula may be obscured from view when the retractable sheath is in the extended position.
- the spring element is a coil spring.
- FIG. 1 illustrates an exploded view of a safety needle device according to a first embodiment
- FIG. 2 illustrates a perspective view of a safety needle device shown in FIG. 1 in an initial state
- FIG. 3 illustrates a sectional view of a first locking element of the safety needle device shown in FIG. 1 ;
- FIG. 4 illustrates another a sectional view of a first locking element of the safety needle device shown in FIG. 1 ;
- FIG. 5 illustrates a cross-sectional view of a safety needle device according to a first embodiment
- FIG. 6 illustrates another cross-sectional view of a safety needle device according to a first embodiment
- FIG. 7 illustrates a perspective view of a safety needle device shown in FIG. 1 in a retracted state
- FIG. 8 illustrates a perspective view of a safety needle device shown in FIG. 1 in an extended state
- FIG. 9 illustrates a perspective view of a safety needle device according to a first embodiment.
- the distal end of the device is the end closest to a patient and the proximal end of the device is the end away from the patient and closest to a practitioner.
- a “safety needle device” refers to a device having a needle suitable for injection that includes one or more features to prevent needle stick injuries.
- a “passive safety needle” refers to a safety needle device with a passive activation mechanism that automatically covers the distal end of the needle after a patient has been injected.
- syringe includes syringes that are indicated for use with needles, nozzle, tubing, or for use in flush systems.
- the term “syringe” refers to a simple pump-like device consisting of a plunger rod that fits tightly in a barrel or tube. The plunger rod can be pulled or pushed along inside the barrel, allowing the syringe to take in and expel a liquid or gas through an opening at the open end of the barrel.
- the open end of the syringe may be fitted with a needle, nozzle, or tubing to help direct the flow of fluid into and out of the barrel.
- the syringe may be sterile or unsterile, depending upon the needs of the technician.
- Embodiments of the safety needle device of the present disclosure provides a passive activation mechanism that overcomes the deficiencies of the known retracting sheath safety needle devices by allowing for a shorter distance for lockout travel, ease of use, increased patient comfort, low part count, low part complexity, relatively compact design, and clear and unobstructed view of needle in an initial position.
- FIGS. 1 - 9 illustrate an exemplary safety needle device 10 according to the present disclosure.
- Safety needle device 10 includes a housing 20 configured to couple to a syringe (not shown). Housing 20 having a proximal end 21 , a distal end 22 , a housing body 23 and an opening 24 located on the distal end.
- a first guide path 30 , a second guide path 32 and a third guide path 34 are disposed on the housing body 23 .
- First guide path 30 and third guide path 34 are generally parallel to a central axis which extends along the housing body 23 .
- Second guide path 32 is positioned at an angle, curvature or taper relative to the axis and intersects the first guide path 30 and third guide path 34 thereby serving to separate the first guide path 30 and third guide path 34 .
- Second guide path 32 permits the guide element 52 to shift between the first guide path 30 and third guide path 34 .
- the one or more guide paths may be straight paths, and one or more guide paths may be helical.
- the two guide paths may be straight paths, and one guide paths may be helical.
- the first and third guide paths may be straight paths, and the second guide path may be helical.
- the first guide path 30 , the second guide path 32 and the third guide path 34 are disposed on the inner diameter of the housing body 23 to prevent tampering. In one or more embodiment, the first guide path 30 , the second guide path 32 and the third guide path 34 are disposed on the inner diameter of the housing body 23 so as not to obstruct needle cannula/needle tip visibility.
- Housing 20 may be of a unitary construction or may be formed from a plurality of components.
- a proximal end 21 and a distal end 22 of the housing 20 can be separate components that are joined using techniques, such as but not limited to sonic welding, adhesive, snap or press fitting, or the like.
- proximal end 21 of housing 20 couples to a retractable sheath 50 such that the retractable sheath 50 is configured to move along and at least partially rotate about a central axis.
- a channel and an aperture are included in the retractable sheath 50 in order to permit the needle cannula 42 and distal tip 44 of needle cannula 42 to pass therethrough.
- Needle hub 40 is disposed on the proximal end 21 of the housing 20 .
- Needle cannula 42 is attached to the needle hub 40 .
- the proximal end of retractable sheath 50 includes a guide element 52 configured to move between an initial position, a retracted position and an extended position with respect to the housing 20 , wherein the initial position partially exposes a distal tip 44 of the needle cannula 42 , the retracted position fully exposes the needle cannula 42 , and the extended position fully covers the distal tip 44 of the needle cannula 42 .
- the term “retractable sheath” is intended to include any sort of tubular member and U-shaped member.
- the retractable sheath 50 is dimensioned to be compatible with the size and type of needle cannula 40 as will be appreciated by those skilled in the art.
- the housing 20 includes a housing body 23 with an internal hollow region in which the retractable sheath 50 may move in the proximal and distal direction.
- the first guide path 30 , the second guide path 32 and third guide path 34 are disposed on the inside surface of housing body 23 configured to directing the retractable sheath 50 during movement.
- the first path, second path and third path are configured to slidingly receive the guide element 52 of the retractable sheath 50 .
- the proximal end 21 of the housing 20 may be connectable to a luer connection or other fluid connector.
- Retractable sheath 50 is slidably mounted and movable in the distal opening 24 of the housing body to slidably accommodate and encase needle cannula 42 projecting axially from housing 20 .
- the distal end of retractable sheath 50 is generally flush with distal end 22 of housing 20 .
- needle cannula 42 may be connected to a needle hub 40 disposed at the proximal end 21 of the housing 20 and having a blunted tip (not shown) or beveled tip (as shown in FIG. 1 ) at the distal tip 44 of needle cannula 42 .
- the needle cannula 42 is disposed in the needle hub 40 in a manner as would be well understood in the art.
- the needle hub 40 may be integrally formed with the proximal end 21 of housing 20 . Needle hub 40 may be configured to be removable or permanently attached to the syringe, or alternatively, needle hub 40 may be integrally formed with the syringe.
- needle hub 40 may include internal or external threads or other suitable coupling, latching, or locking features such as tabs, slots, projections, pressure/snap fits, and the like, for removably coupling the safety device to a syringe.
- the housing 20 includes a generally cylindrically reduced needle support 41 that extends axially from the needle hub 40 to support the needle cannula 42 . Housing 20 and/or needle hub 40 are in fluid communication with the needle cannula 42 to permitting fluid to pass between the syringe and the needle cannula 42 .
- the needle cannula 42 extends from the needle hub 40 disposed in the housing 20 and extends to a distal tip 44 .
- Distal tip 44 of the needle cannula 42 is partially exposed and protruding from the distal end of the retractable sheath 50 so as to be visible when the retractable sheath 50 is in an initial position, as shown in FIG. 2 .
- the shaft of the needle cannula 42 is exposed from the retractable sheath 50 when the retractable sheath 50 is in a retracted position.
- retractable sheath 50 is generally comprised of a tubular portion and is slidably retractable along the length of the needle cannula 42 such that a distal tip 44 of the needle cannula 42 is partially exposed and protruding from the distal end of the retractable sheath 50 when in an initial position so as to be visible to a user.
- a substantial or entire portion of needle cannula 42 is exposed when the retractable sheath 50 is in its retracted position.
- the length of needle cannula 42 which extends from the needle hub 40 in a distal direction is completely encased when retractable sheath 50 is in its extended position, as shown in FIG. 8 .
- the needle cannula 42 in accordance with the present disclosure can be formed from conventional materials such as steel or more preferably stainless steel. It will be realized by the skilled artisan that medical grade plastics, composites, ceramics, or like materials can be substituted.
- the inside diameter of the retracting sheath 50 is selected so that it will fit closely over needle cannula 42 .
- the retracting sheath 50 may be made of any suitable material, but preferably of a polymer which is tough enough to protect needle cannula 42 .
- the proximal end 51 of retractable sheath 50 includes a guide element 52 that extends radially outward from the proximal end of retractable sheath 50 and is configured to engage one or more paths formed on the inside surface of the housing body 23 .
- guide element 52 may be an outwardly extending peg that seats against a ledge of the distal end of the housing as shown in FIG. 2 .
- housing 20 has an opening that receives the retractable sheath 50 .
- retractable sheath 50 may be disposed and movable in the housing body 23 .
- the retractable sheath 50 is spring loaded, and is supplied to the user with the retracting sheath 50 partially covering the needle cannula 42 so that the distal tip of the needle cannula is exposed and visible in an initial state, as shown in FIG. 2 .
- the guide element 52 of the retractable sheath 50 is disposed in the first guide path of the housing body.
- the guide element is a peg.
- the retractable sheath 50 Upon administration of the injection, the retractable sheath 50 moves from an initial position whereby the distal tip 44 of the needle cannula 42 is exposed to a retracted position whereby the needle cannula is increasingly exposed so that the needle cannula may penetrate the injection site. As shown in FIGS. 3 - 7 , the retractable sheath 50 rotates with respect to the housing 20 by way of rotating cam 80 during movement from the initial position to the retracted position.
- the application of force by the user in the distal direction causes the guide element 52 of retractable sheath 50 to move in a proximal direction such that guide element switches from the first guide path of the housing body to an angled second guide path of the housing body.
- Rotation of the retractable sheath 50 from the initial position to the retracted position transfers the guide element 52 of the retractable sheath from the first guide path 30 on the housing body 23 to the third guide path 34 on the housing body via the second guide path 32 .
- the retractable sheath translates from the initial position to the retracted position without impediment.
- the first locking element 60 includes a tab on a distal end of the retractable sheath.
- the first locking element 60 further includes a locking rib on the housing.
- the first locking member may comprise a locking rib on a distal end of the retractable sheath and a tab on the housing.
- the first locking element 60 is positioned at least partially within an opening included in the housing body 23 .
- the first locking element 60 is generally resilient, so that the radially inwardly disposed second ends can flex and then return to the original position even after the ends have been radially outwardly deflected.
- the first end is larger than the second end, e.g. the axial locking member can taper from the first end to the second end 54 .
- the first locking member may include a latching member, such as a hook, clasp, detent, ratchet, or other structure.
- a locking rib of the housing engages to a tab on the distal end of the retractable sheath thereby preventing further rotational movement of the rotation cam and therefore ensuring that the guide element does not return to its initial position on the first guide path.
- retractable sheath 50 retracts into housing 20 allowing the injection site to be penetrated by the needle tip and needle cannula.
- the first locking member inhibits reuse of the device by inhibiting rotation of the retractable sheath.
- the user withdraws the needle cannula from the patient, thus causing the stored energy of spring element 90 to allow guide element 52 of the retractable sheath 50 to proceed along the third guide path 34 to allow retractable sheath 50 to fully cover needle cannula 42 in the extended position.
- the spring element 90 biases the retractable sheath 50 in a distal direction to cover the distal tip 44 of needle cannula 42 causing activation of the second locking element to prevent further translational movement of the retractable sheath 50 within the housing body 23 . Movement of the retractable sheath from the retracted position to the extended position engages the second locking member to a distal tip of the needle cannula.
- the second locking element 70 is disposed on the retractable sheath and rides along the needle cannula until the second locking element covers the distal tip 44 of the needle cannula 42 in the extended position. In one or more embodiments, the second locking element 70 inhibits reuse of the safety needle device 10 by inhibiting further translational movement of the retractable sheath 50 within the housing body 23 . Needle cannula 42 is obscured from view when the retractable sheath is in the extended position. As shown in FIG.
- the stored force of spring element 90 causes the retracting sheath 50 to extend, and at the end of the stroke, a second locking member extends over the distal tip 44 of the needle cannula 42 to lock the retractable sheath 50 thereby completing a passive safety lock-out.
- the second locking member is a metal clip.
- Spring element 90 includes a proximal end, a main body, and a distal end. In one or more embodiments, as shown in FIG. 1 , spring element 90 comprises a compression or coil spring. The spring element 90 biases the retractable sheath toward the extended position.
- FIG. 1 illustrates a safety needle device 10 that may be removably coupled to a standard or specially configured syringe (not shown).
- the safety needle device 10 is configured to be coupled to and removed from a syringe, the safety needle device 10 may instead be integrally formed with the syringe.
- the syringe is generally of a known type suitable for the withdrawal and injection and/or aspiration of fluids or other solutions by way of the safety needle device 10 .
- the safety needle device is a single use device.
- the safety needle device is a passively activated device in which the safety features provide post-injection needle shielding without additional intervention by the user.
- the safety needle device 10 is illustrated in an initial state wherein the retractable sheath 50 is in a partially retracted configuration. Further retraction of the retractable sheath 50 is generally initiated by a user applying pressure on the safety needle device 10 and/or syringe in the distal direction, which thereby encourages the retractable sheath 50 proximally against the bias of the spring element 90 . This retraction of the retractable sheath 50 in turn further exposes the distal tip 44 of the needle cannula 42 and initiates penetration by the needle cannula 42 into the patient's skin.
- the guide element 52 of the housing 14 which is initially positioned in the first guide path 30 , directs the retractable sheath 50 to immediately move toward the second guide path 32 .
- the guide element 52 passes through the second guide path 32 thereby encouraging the retractable sheath 50 to rotate on the rotating cam about the axis.
- the guide element 52 may not return to the first guide path 30 due to the rotating cam engaging the first locking member such that a locking rib of the housing engages the tab on the distal end of the retractable sheath to prevent further rotation of the rotating cam and thus preventing the guide member from returning to the first guide path 30 .
- spring element 90 engages and extends between the proximal end of the retractable sheath and the proximal end of the housing.
- the spring biases the retractable sheath 50 toward an initial position in which the guide element 52 of the retractable sheath 50 is biased into engagement with the first guide path located at the distal end of the housing body 23 allowing the distal tip 44 of the needle cannula 42 to be exposed and visible in the initial position.
- the retractable sheath 50 completely covers the distal tip 44 of the needle cannula 42 in the extended position.
- Many types of springs may be employed, such as but not limited to a helical coil spring, conical spring, wave-spring, Belleville washer, or the like.
- the spring element 90 is configured to facilitate retraction of the retractable sheath 50 by a user applying distal pressure to the syringe and/or the safety needle device 10 with just one hand.
- rotating cam 80 includes having an outwardly extending portion from which an impeding member, such as a tab or other resilient member, extends, e.g. circumferentially, radially, axially, a combination thereof, or the like.
- the end of the impeding member of the rotating cam may be shaped as a radially outwardly extending wedge having an inclined face or flat face which interacts with a wedge-shaped rotational locking member, e.g. an axial rib, extends radially inwardly from the inner surface of the housing and includes an inclined face and a generally flat face.
- the inclined face of the wedge may be configured to be in the opposite direction as the inclined face.
- the end and rotational locking member may be wedge-shaped, hemispherical, frusto-conical, or the like.
- the axial length of the rotational locking member is greater than the axial length of the impeding member.
- at least a portion of the impeding member is configured to fit into at least a portion of the rotational locking member or vice versa.
- the impeding member can comprise a tab configured to fit within a slot included in the rotational locking member.
- Safety needle device 10 can be formed using many manufacturing processes sufficient to provide the desired shape of the components.
- one or more components are made by a molding process, such as but not limited to injection molding, compression molding, blow molding, transfer molding, or similar.
- one or more components are formed by forging, machining, casting, stamping, extrusion, a combination thereof, or the like.
- the safety needle device 10 is constructed from a biocompatible material.
- one or more of the components of the safety needle device 10 are plastic (e.g. polyurethane, etc.) or metal (e.g., stainless steel, etc.).
- the housing 14 and/or the retractable sheath 50 are constructed of materials that are either translucent or opaque.
- movement of the retractable sheath 50 automatically engages a first locking element 60 and second locking element 70 . In some embodiments, movement of the retractable sheath 50 from an about fully retracted position to an about fully extended position automatically prevents or inhibits reuse of the safety needle device 10 .
- the safety needle device may manufactured by forming the housing 20 with the needle support 41 , the distal opening 24 , the first guide path 30 , second guide path 32 and third guide path 34 .
- the manufacturing process can include the step of assembling the housing 20 .
- a retractable sheath is formed having guide element 52 which is aligned with first guide path 30 .
- the retractable sheath 50 is slidingly moved through the distal opening 24 .
- the needle cannula 42 is coupled with the needle support 41 of the housing 20 .
- the spring element 90 is inserted into the housing body 23 and positioned to bias the retractable sheath 50 .
- the guide element 52 shifts from the second guide path 32 to the third guide path 34 , thus further rotating the retractable sheath 50 with respect to the housing 20 .
- the stored spring energy of the spring element 90 to distally extend the retractable sheath 50 .
- the retractable sheath 50 covers the needle cannula 42 into the channel of the hub body thereby covering the distal end of the needle cannula 42 .
- the distal movement of the retractable sheath 50 also slides the guide element 52 along the third guide path 34 .
- the engagement of the first locking member inhibits or prevents counter-rotation of the retractable sheath 50 , which in turn prevents the guide element 52 from shifting back into the first guide path 30 at intersection between the first guide path 30 and the second guide path 32 .
- the second locking element 70 moves distally over the distal tip to cover the distal tip 44 of the needle cannula 4 to prevent reuse of the safety needle device 10 .
- the retractable sheath 50 has been fully extended and fully covers the needle cannula 42 .
- the second locking element 70 thus presents a physical stop to inhibit the retractable sheath 50 from being proximally retracted again.
- Housing 20 couples to retractable sheath 50 to allow retractable sheath 50 to translate along and at least partially rotate about the axis.
- embodiments of the present disclosure utilize guide element 52 on the retractable sheath traveling along a first guide path 30 , second guide path 32 and third guide path 34 disposed inside housing 20 .
- the guide element 52 on the retractable sheath 50 travels along the a first guide path 30 , second guide path 32 and third guide path 34 rotating the retractable sheath from an initial position to a second position as it moves axially.
- a first locking element 60 comprising two locking tabs at the top of the retractable sheath 50 snap into ribs within the housing 20 . The two locking tabs serve to keep retractable sheath 50 from rotating back to the initial position ensuring that final lockout with second locking element 70 will occur.
- the user can continue to insert the needle to the desired depth in the patient and the retractable sheath 50 will move axially within the housing path.
- spring element 90 within the system will push the retractable sheath 50 down the third guide path 34 to a final position and the second locking element 70 will automatically cover the distal tip 44 of the needle cannula 42 thereby passively protecting the user from needle stick injury.
- Stroke length is the sum of needle cannula length and retractable sheath 50 lockout travel.
- the distance between proximal end of retractable sheath 50 and distal tip 44 of needle cannula 42 is a stack-up of tolerances and safety margin to insure needle stick injury (NSI) is prevented following use.
- overall length of the safety needle device may be reduced when the spring element is allowed to collapse inside both the retractable sheath 50 and housing 20 .
- overall length by the solid height and subsequently lowering forces applied to a patient's skin.
- overall length of the safety needle device may also be reduced by using telescoping components.
- the safety needle device 10 can include a cap 100 that is removably coupled to the housing 20 to reduce or prevent contamination of the needle cannula during shipping and storage of the safety needle device 10 .
- the cap 100 is generally kept in the closed position until just prior to an injection and/or aspiration procedure, at which time the cap 100 removed from the housing 20 .
- cap 100 is configured to assist in properly drawing a dose from a vial.
- Any suitable caps or packaging comprising a safety feature may be used in conjunction with the safety needle device disclosed herein.
- Any suitable caps or packaging comprising a safety feature may be used in conjunction with the safety needle device disclosed herein.
- Types of safety features vary in structure and mechanics but exemplary caps or packaging include, but are not limited to, those described in commonly owned, U.S. Patent Application Ser. Nos. 62/433,044, 62/433,526 and 62,433,297, the disclosures of which are incorporated herein by reference in their entireties.
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Abstract
A safety needle device is disclosed having a housing configured to couple to a syringe, the housing having a proximal end, a distal end, and a housing body. A first guide path, a second guide path and a third guide path may be disposed on the housing body. A needle hub is disposed on the proximal end of the housing and a needle cannula is attached to the needle hub. The device having a retractable sheath configured to move between an initial position, a retracted position and an extended position with respect to the housing, wherein the initial position partially exposes a distal tip of the needle cannula, the retracted position fully exposes the needle cannula, and the extended position fully covers the distal tip of the needle cannula. The retractable sheath also may have a guide element. The first, second and third guide paths are configured to slidingly receive the guide element. The device also having a first locking member, a second locking member, a rotating cam disposed in the housing body, and a spring element to bias the retractable sheath to an extended state to cover the distal end of the needle cannula upon completion of an injection.
Description
- This application is a continuation of U.S. patent application Ser. No. 16/818,350, filed on Mar. 13, 2020, issued as U.S. Pat. No. 11,559,631 on Jan. 24, 2023, which is a continuation of U.S. patent application Ser. No. 15/837,008, filed on Dec. 11, 2017, issued as U.S. Pat. No. 10,589,036 on Mar. 17, 2020, which claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Application No. 62/433,294, filed Dec. 13, 2016, the disclosures of which are incorporated herein by reference in their entirety.
- The present disclosure relates generally to a safety needle device, and more particularly to a single-use passive safety needle device having a housing, a first guide path, a second guide path, a third guide path intersecting the first guide path and the second guide path, a needle hub, a needle cannula, a retractable sheath, a first locking member, a second locking member, a rotating cam, and a spring to bias the retractable sheath in a distal direction to cover the distal end of the needle cannula.
- Needle devices are used throughout the medical industry for the injection and withdrawal of a wide variety of fluids and solutions into and from the human body. Because of the numerous potential hazards associated with the handling and manipulation of bodily fluids, and particularly blood, there are a number of known safety features that are frequently incorporated into various types of needle devices to protect the practitioner from accidental exposure to the needle.
- Prior safety needle devices include several disadvantages including having a retractable sheath requiring long stroke distances to activate the safety feature, multi-component retraction and locking elements, and conveying an undesirable significant force against a patient's skin during activation of the safety feature upon receiving an injection. Conventional retraction syringe assemblies often also do not incorporate reuse prevention features, and thus, the retraction mechanism of the syringe may be reset so the syringe barrel may be reused. The reuse of syringe assemblies without sterilization or sufficient sterilization is believed to facilitate the transfer of contagious diseases. Further, the retraction features of conventional syringes may also require the user to actively activate the retraction mechanism. Accordingly, the chance of human error in failure to activate or properly activate the retraction mechanism can lead to continued exposure of needles leading to needle stick injuries.
- Some known retracting sheath safety needle devices have been developed to include a single-use safety needle device assembly that obscures a substantial majority or an entirety of an injection needle from view before, during, and after an injection procedure. However, many injection procedures require that the practitioner know precisely the location and depth to which the needle is inserted in the patient's tissue to be sure that medication is delivered to an appropriate location. In addition, there exists a tendency for many users to falsely assume that they were “safe” from needle stick injuries, even in the non-locked initial state, due to the tip of the prior art retracting sheath safety needle devices being fully covered in an unlocked state.
- Thus, there is a need in the art to provide a safety needle device having a passive activation mechanism that overcomes the deficiencies of the known retracting sheath safety needle devices and which allows for shorter stroke distance, ease of use, increased patient comfort, low part count, low part complexity, relatively compact design, and clear and unobstructed view of needle in an initial position.
- One aspect of the present disclosure pertains to a safety needle device including a housing configured to couple to a syringe, the housing having a proximal end, a distal end, and a housing body. The safety needle device also includes a first guide path, a second guide path and a third guide path disposed on the housing body, the second guide path intersecting the first guide path and the third guide path. In one or more embodiments, the one or more guide paths may be straight paths, and one or more guide paths may be helical. In one or more embodiments, the two guide paths may be straight paths, and one guide paths may be helical. In one or more embodiments, the first and third guide paths may be straight paths, and the second guide path may be helical. A needle hub is disposed on the proximal end of the housing with a needle cannula attached to the needle hub. The safety needle device may also include a retractable sheath having a guide element configured to move between an initial position, a retracted position and an extended position with respect to the housing, wherein the initial position partially exposes a distal tip of the needle cannula, the retracted position fully exposes the needle cannula, and the extended position fully covers the distal tip of the needle cannula. The first guide path and the second guide path are disposed on the housing body configured to receive the guide element. The safety needle device also includes a first locking member, a second locking member; a rotating cam disposed in the housing body and connected to the retractable sheath; and a spring element. In one or more embodiments, the safety needle device is a single use device. In one or more embodiments, the safety needle device is a passively activated device in which the safety features provide post-injection needle shielding without additional intervention by the user.
- In one or more embodiments, the first locking member may comprise a tab on a distal end of the retractable sheath and a locking rib on the housing. In one or more embodiments, the first locking member may comprise a locking rib on a distal end of the retractable sheath and a tab on the housing. Movement of the retractable sheath from the initial position to the retracted position may engage the locking rib of the housing to the tab on the distal end of the retractable sheath. The retractable sheath may rotate with respect to the housing during movement from the initial position to the retracted position. Rotation of the retractable sheath from the initial position to the retracted position may transfer the guide element of the retractable sheath from the first guide path on the housing to the third guide path on the housing via the second guide path. In one or more embodiments, the guide element may be a peg. In one or more embodiments, the retractable sheath translates from the initial position to the retracted position without impediment.
- In one or more embodiments, movement of the retractable sheath from the retracted position to the extended position may engage the second locking member to a distal tip of the needle cannula. In one or more embodiments, the second locking member may be a metal latch.
- In one or more embodiments, the first locking member may inhibit reuse of the device by inhibiting rotation of the retractable sheath. The second locking member may inhibit reuse of the device by inhibiting translation of the retractable sheath.
- In one or more embodiments, the spring element biases the retractable sheath toward the extended position. The needle cannula may be obscured from view when the retractable sheath is in the extended position.
- In one or more embodiments, the spring element is a coil spring.
-
FIG. 1 illustrates an exploded view of a safety needle device according to a first embodiment; -
FIG. 2 illustrates a perspective view of a safety needle device shown inFIG. 1 in an initial state; -
FIG. 3 illustrates a sectional view of a first locking element of the safety needle device shown inFIG. 1 ; -
FIG. 4 illustrates another a sectional view of a first locking element of the safety needle device shown inFIG. 1 ; -
FIG. 5 illustrates a cross-sectional view of a safety needle device according to a first embodiment; -
FIG. 6 illustrates another cross-sectional view of a safety needle device according to a first embodiment; -
FIG. 7 illustrates a perspective view of a safety needle device shown inFIG. 1 in a retracted state; -
FIG. 8 illustrates a perspective view of a safety needle device shown inFIG. 1 in an extended state; and -
FIG. 9 illustrates a perspective view of a safety needle device according to a first embodiment. - Before describing several exemplary embodiments of the disclosure, it is to be understood that the disclosure is not limited to the details of construction or process steps set forth in the following description. The disclosure is capable of other embodiments and of being practiced or being carried out in various ways.
- With respect to terms used in this disclosure, the following definitions are provided.
- As used herein, the use of “a,” “an,” and “the” includes the singular and plural.
- In this disclosure, a convention is followed wherein the distal end of the device is the end closest to a patient and the proximal end of the device is the end away from the patient and closest to a practitioner.
- As used herein, a “safety needle device” refers to a device having a needle suitable for injection that includes one or more features to prevent needle stick injuries. As used herein, a “passive safety needle” refers to a safety needle device with a passive activation mechanism that automatically covers the distal end of the needle after a patient has been injected.
- Reference to “syringe” includes syringes that are indicated for use with needles, nozzle, tubing, or for use in flush systems. As used herein, the term “syringe” refers to a simple pump-like device consisting of a plunger rod that fits tightly in a barrel or tube. The plunger rod can be pulled or pushed along inside the barrel, allowing the syringe to take in and expel a liquid or gas through an opening at the open end of the barrel. The open end of the syringe may be fitted with a needle, nozzle, or tubing to help direct the flow of fluid into and out of the barrel. The syringe may be sterile or unsterile, depending upon the needs of the technician.
- Embodiments of the safety needle device of the present disclosure provides a passive activation mechanism that overcomes the deficiencies of the known retracting sheath safety needle devices by allowing for a shorter distance for lockout travel, ease of use, increased patient comfort, low part count, low part complexity, relatively compact design, and clear and unobstructed view of needle in an initial position.
-
FIGS. 1-9 illustrate an exemplarysafety needle device 10 according to the present disclosure.Safety needle device 10 includes ahousing 20 configured to couple to a syringe (not shown).Housing 20 having aproximal end 21, adistal end 22, ahousing body 23 and anopening 24 located on the distal end. Afirst guide path 30, asecond guide path 32 and athird guide path 34 are disposed on thehousing body 23. First guidepath 30 andthird guide path 34 are generally parallel to a central axis which extends along thehousing body 23.Second guide path 32 is positioned at an angle, curvature or taper relative to the axis and intersects thefirst guide path 30 andthird guide path 34 thereby serving to separate thefirst guide path 30 andthird guide path 34.Second guide path 32 permits theguide element 52 to shift between thefirst guide path 30 andthird guide path 34. In one or more embodiments, the one or more guide paths may be straight paths, and one or more guide paths may be helical. In one or more embodiments, the two guide paths may be straight paths, and one guide paths may be helical. In one or more embodiments, the first and third guide paths may be straight paths, and the second guide path may be helical. In one or more embodiment, thefirst guide path 30, thesecond guide path 32 and thethird guide path 34 are disposed on the inner diameter of thehousing body 23 to prevent tampering. In one or more embodiment, thefirst guide path 30, thesecond guide path 32 and thethird guide path 34 are disposed on the inner diameter of thehousing body 23 so as not to obstruct needle cannula/needle tip visibility. -
Housing 20 may be of a unitary construction or may be formed from a plurality of components. In one or more embodiments, aproximal end 21 and adistal end 22 of thehousing 20 can be separate components that are joined using techniques, such as but not limited to sonic welding, adhesive, snap or press fitting, or the like. - As shown in
FIG. 1 ,proximal end 21 ofhousing 20 couples to aretractable sheath 50 such that theretractable sheath 50 is configured to move along and at least partially rotate about a central axis. A channel and an aperture are included in theretractable sheath 50 in order to permit theneedle cannula 42 anddistal tip 44 ofneedle cannula 42 to pass therethrough. -
Needle hub 40 is disposed on theproximal end 21 of thehousing 20.Needle cannula 42 is attached to theneedle hub 40. The proximal end ofretractable sheath 50 includes aguide element 52 configured to move between an initial position, a retracted position and an extended position with respect to thehousing 20, wherein the initial position partially exposes adistal tip 44 of theneedle cannula 42, the retracted position fully exposes theneedle cannula 42, and the extended position fully covers thedistal tip 44 of theneedle cannula 42. The term “retractable sheath” is intended to include any sort of tubular member and U-shaped member. Theretractable sheath 50 is dimensioned to be compatible with the size and type ofneedle cannula 40 as will be appreciated by those skilled in the art. Thehousing 20 includes ahousing body 23 with an internal hollow region in which theretractable sheath 50 may move in the proximal and distal direction. Thefirst guide path 30, thesecond guide path 32 andthird guide path 34 are disposed on the inside surface ofhousing body 23 configured to directing theretractable sheath 50 during movement. In one or more embodiments, the first path, second path and third path are configured to slidingly receive theguide element 52 of theretractable sheath 50. - In one or more embodiments, the
proximal end 21 of thehousing 20 may be connectable to a luer connection or other fluid connector.Retractable sheath 50 is slidably mounted and movable in thedistal opening 24 of the housing body to slidably accommodate and encaseneedle cannula 42 projecting axially fromhousing 20. The distal end ofretractable sheath 50 is generally flush withdistal end 22 ofhousing 20. - As shown in
FIG. 1 ,needle cannula 42 may be connected to aneedle hub 40 disposed at theproximal end 21 of thehousing 20 and having a blunted tip (not shown) or beveled tip (as shown inFIG. 1 ) at thedistal tip 44 ofneedle cannula 42. Theneedle cannula 42 is disposed in theneedle hub 40 in a manner as would be well understood in the art. Theneedle hub 40 may be integrally formed with theproximal end 21 ofhousing 20.Needle hub 40 may be configured to be removable or permanently attached to the syringe, or alternatively,needle hub 40 may be integrally formed with the syringe. For example,needle hub 40 may include internal or external threads or other suitable coupling, latching, or locking features such as tabs, slots, projections, pressure/snap fits, and the like, for removably coupling the safety device to a syringe. In some embodiments, thehousing 20 includes a generally cylindrically reduced needle support 41 that extends axially from theneedle hub 40 to support theneedle cannula 42.Housing 20 and/orneedle hub 40 are in fluid communication with theneedle cannula 42 to permitting fluid to pass between the syringe and theneedle cannula 42. - The
needle cannula 42 extends from theneedle hub 40 disposed in thehousing 20 and extends to adistal tip 44.Distal tip 44 of theneedle cannula 42 is partially exposed and protruding from the distal end of theretractable sheath 50 so as to be visible when theretractable sheath 50 is in an initial position, as shown inFIG. 2 . The shaft of theneedle cannula 42 is exposed from theretractable sheath 50 when theretractable sheath 50 is in a retracted position. - As illustrated in several of the drawings, most notably
FIGS. 1 and 2 ,retractable sheath 50 is generally comprised of a tubular portion and is slidably retractable along the length of theneedle cannula 42 such that adistal tip 44 of theneedle cannula 42 is partially exposed and protruding from the distal end of theretractable sheath 50 when in an initial position so as to be visible to a user. A substantial or entire portion ofneedle cannula 42 is exposed when theretractable sheath 50 is in its retracted position. The length ofneedle cannula 42 which extends from theneedle hub 40 in a distal direction is completely encased whenretractable sheath 50 is in its extended position, as shown inFIG. 8 . - The
needle cannula 42 in accordance with the present disclosure can be formed from conventional materials such as steel or more preferably stainless steel. It will be realized by the skilled artisan that medical grade plastics, composites, ceramics, or like materials can be substituted. - The inside diameter of the retracting
sheath 50 is selected so that it will fit closely overneedle cannula 42. The retractingsheath 50 may be made of any suitable material, but preferably of a polymer which is tough enough to protectneedle cannula 42. - The proximal end 51 of
retractable sheath 50 includes aguide element 52 that extends radially outward from the proximal end ofretractable sheath 50 and is configured to engage one or more paths formed on the inside surface of thehousing body 23. In one or more embodiments,guide element 52 may be an outwardly extending peg that seats against a ledge of the distal end of the housing as shown inFIG. 2 . As shown inFIGS. 1 and 2 ,housing 20 has an opening that receives theretractable sheath 50. - In one or more embodiments,
retractable sheath 50 may be disposed and movable in thehousing body 23. Theretractable sheath 50 is spring loaded, and is supplied to the user with the retractingsheath 50 partially covering theneedle cannula 42 so that the distal tip of the needle cannula is exposed and visible in an initial state, as shown inFIG. 2 . In the initial state, theguide element 52 of theretractable sheath 50 is disposed in the first guide path of the housing body. In one or more embodiments, the guide element is a peg. Upon administration of the injection, theretractable sheath 50 moves from an initial position whereby thedistal tip 44 of theneedle cannula 42 is exposed to a retracted position whereby the needle cannula is increasingly exposed so that the needle cannula may penetrate the injection site. As shown inFIGS. 3-7 , theretractable sheath 50 rotates with respect to thehousing 20 by way of rotatingcam 80 during movement from the initial position to the retracted position. - During administration of an injection to a patient, the application of force by the user in the distal direction causes the
guide element 52 ofretractable sheath 50 to move in a proximal direction such that guide element switches from the first guide path of the housing body to an angled second guide path of the housing body. Rotation of theretractable sheath 50 from the initial position to the retracted position transfers theguide element 52 of the retractable sheath from thefirst guide path 30 on thehousing body 23 to thethird guide path 34 on the housing body via thesecond guide path 32. In or more embodiments, the retractable sheath translates from the initial position to the retracted position without impediment. - As shown in
FIGS. 3-6 , a continued application of force by the user in the distal direction causes rotational movement ofrotation cam 80 causingguide element 52 to move from the second guide path of the housing body to a third guide path thus activating thefirst locking element 60. In one or more embodiments, thefirst locking element 60 includes a tab on a distal end of the retractable sheath. In one or more embodiments, thefirst locking element 60 further includes a locking rib on the housing. In one or more embodiments, the first locking member may comprise a locking rib on a distal end of the retractable sheath and a tab on the housing. Movement of the retractable sheath from the initial position to the retracted position engages the locking rib of the housing to the tab on the distal end of the retractable sheath. In some embodiments thefirst locking element 60 is positioned at least partially within an opening included in thehousing body 23. In some embodiments, thefirst locking element 60 is generally resilient, so that the radially inwardly disposed second ends can flex and then return to the original position even after the ends have been radially outwardly deflected. In some embodiments, the first end is larger than the second end, e.g. the axial locking member can taper from the first end to the second end 54. In one or more embodiments, the first locking member may include a latching member, such as a hook, clasp, detent, ratchet, or other structure. - Upon activating the first locking member, a locking rib of the housing engages to a tab on the distal end of the retractable sheath thereby preventing further rotational movement of the rotation cam and therefore ensuring that the guide element does not return to its initial position on the first guide path. Upon continued application of force by pressing
retractable sheath 50 against the skin of a patient at the location where it is desired to insertneedle cannula 42,retractable sheath 50 retracts intohousing 20 allowing the injection site to be penetrated by the needle tip and needle cannula. In one or more embodiments, the first locking member inhibits reuse of the device by inhibiting rotation of the retractable sheath. - Upon completion of an injection to the patient, the user withdraws the needle cannula from the patient, thus causing the stored energy of
spring element 90 to allowguide element 52 of theretractable sheath 50 to proceed along thethird guide path 34 to allowretractable sheath 50 to fully coverneedle cannula 42 in the extended position. Thespring element 90 biases theretractable sheath 50 in a distal direction to cover thedistal tip 44 ofneedle cannula 42 causing activation of the second locking element to prevent further translational movement of theretractable sheath 50 within thehousing body 23. Movement of the retractable sheath from the retracted position to the extended position engages the second locking member to a distal tip of the needle cannula. - In one or more embodiments, the
second locking element 70 is disposed on the retractable sheath and rides along the needle cannula until the second locking element covers thedistal tip 44 of theneedle cannula 42 in the extended position. In one or more embodiments, thesecond locking element 70 inhibits reuse of thesafety needle device 10 by inhibiting further translational movement of theretractable sheath 50 within thehousing body 23.Needle cannula 42 is obscured from view when the retractable sheath is in the extended position. As shown inFIG. 8 , as the injection is completed and thedistal tip 44 ofneedle cannula 42 is pulled from injection site, the stored force ofspring element 90 causes the retractingsheath 50 to extend, and at the end of the stroke, a second locking member extends over thedistal tip 44 of theneedle cannula 42 to lock theretractable sheath 50 thereby completing a passive safety lock-out. In one embodiment, the second locking member is a metal clip. -
Spring element 90 includes a proximal end, a main body, and a distal end. In one or more embodiments, as shown inFIG. 1 ,spring element 90 comprises a compression or coil spring. Thespring element 90 biases the retractable sheath toward the extended position. -
FIG. 1 illustrates asafety needle device 10 that may be removably coupled to a standard or specially configured syringe (not shown). Although the illustratedsafety needle device 10 is configured to be coupled to and removed from a syringe, thesafety needle device 10 may instead be integrally formed with the syringe. The syringe is generally of a known type suitable for the withdrawal and injection and/or aspiration of fluids or other solutions by way of thesafety needle device 10. In one or more embodiments, the safety needle device is a single use device. In one or more embodiments, the safety needle device is a passively activated device in which the safety features provide post-injection needle shielding without additional intervention by the user. - Referring now to
FIG. 2 , thesafety needle device 10 is illustrated in an initial state wherein theretractable sheath 50 is in a partially retracted configuration. Further retraction of theretractable sheath 50 is generally initiated by a user applying pressure on thesafety needle device 10 and/or syringe in the distal direction, which thereby encourages theretractable sheath 50 proximally against the bias of thespring element 90. This retraction of theretractable sheath 50 in turn further exposes thedistal tip 44 of theneedle cannula 42 and initiates penetration by theneedle cannula 42 into the patient's skin. Theguide element 52 of the housing 14, which is initially positioned in thefirst guide path 30, directs theretractable sheath 50 to immediately move toward thesecond guide path 32. As theretractable sheath 50 moves proximally, theguide element 52 passes through thesecond guide path 32 thereby encouraging theretractable sheath 50 to rotate on the rotating cam about the axis. Upon reaching the intersection of the second and third guide paths, theguide element 52 may not return to thefirst guide path 30 due to the rotating cam engaging the first locking member such that a locking rib of the housing engages the tab on the distal end of the retractable sheath to prevent further rotation of the rotating cam and thus preventing the guide member from returning to thefirst guide path 30. - In one or more embodiment,
spring element 90 engages and extends between the proximal end of the retractable sheath and the proximal end of the housing. The spring biases theretractable sheath 50 toward an initial position in which theguide element 52 of theretractable sheath 50 is biased into engagement with the first guide path located at the distal end of thehousing body 23 allowing thedistal tip 44 of theneedle cannula 42 to be exposed and visible in the initial position. Theretractable sheath 50 completely covers thedistal tip 44 of theneedle cannula 42 in the extended position. Many types of springs may be employed, such as but not limited to a helical coil spring, conical spring, wave-spring, Belleville washer, or the like. In some embodiments, thespring element 90 is configured to facilitate retraction of theretractable sheath 50 by a user applying distal pressure to the syringe and/or thesafety needle device 10 with just one hand. - In one or more embodiments, as shown in
FIGS. 3, 4, 5 and 6 , rotatingcam 80 includes having an outwardly extending portion from which an impeding member, such as a tab or other resilient member, extends, e.g. circumferentially, radially, axially, a combination thereof, or the like. In one or more embodiments, the end of the impeding member of the rotating cam may be shaped as a radially outwardly extending wedge having an inclined face or flat face which interacts with a wedge-shaped rotational locking member, e.g. an axial rib, extends radially inwardly from the inner surface of the housing and includes an inclined face and a generally flat face. In one or more embodiments, the inclined face of the wedge may be configured to be in the opposite direction as the inclined face. The end and rotational locking member may be wedge-shaped, hemispherical, frusto-conical, or the like. In some embodiments, the axial length of the rotational locking member is greater than the axial length of the impeding member. In some embodiments, at least a portion of the impeding member is configured to fit into at least a portion of the rotational locking member or vice versa. For example, the impeding member can comprise a tab configured to fit within a slot included in the rotational locking member. -
Safety needle device 10, and components thereof, can be formed using many manufacturing processes sufficient to provide the desired shape of the components. In some embodiments one or more components are made by a molding process, such as but not limited to injection molding, compression molding, blow molding, transfer molding, or similar. In some embodiments, one or more components are formed by forging, machining, casting, stamping, extrusion, a combination thereof, or the like. - In many embodiments, the
safety needle device 10 is constructed from a biocompatible material. In some arrangements one or more of the components of thesafety needle device 10 are plastic (e.g. polyurethane, etc.) or metal (e.g., stainless steel, etc.). In some embodiments, the housing 14 and/or theretractable sheath 50 are constructed of materials that are either translucent or opaque. - In some embodiments, movement of the
retractable sheath 50 automatically engages afirst locking element 60 andsecond locking element 70. In some embodiments, movement of theretractable sheath 50 from an about fully retracted position to an about fully extended position automatically prevents or inhibits reuse of thesafety needle device 10. - In some embodiments, the safety needle device may manufactured by forming the
housing 20 with the needle support 41, thedistal opening 24, thefirst guide path 30,second guide path 32 andthird guide path 34. In embodiments in whichhousing 20 comprises multiple pieces, the manufacturing process can include the step of assembling thehousing 20. A retractable sheath is formed havingguide element 52 which is aligned withfirst guide path 30. Theretractable sheath 50 is slidingly moved through thedistal opening 24. Theneedle cannula 42 is coupled with the needle support 41 of thehousing 20. Thespring element 90 is inserted into thehousing body 23 and positioned to bias theretractable sheath 50. - As shown in
FIG. 7 , as theretractable sheath 50 continues to retract into thehousing body 23, to further expose theneedle cannula 42 to alength 500, theguide element 52 shifts from thesecond guide path 32 to thethird guide path 34, thus further rotating theretractable sheath 50 with respect to thehousing 20. Upon withdrawal of theneedle cannula 42 from the patient, the stored spring energy of thespring element 90 to distally extend theretractable sheath 50. As theretractable sheath 50 distally extends, it covers theneedle cannula 42 into the channel of the hub body thereby covering the distal end of theneedle cannula 42. The distal movement of theretractable sheath 50 also slides theguide element 52 along thethird guide path 34. The engagement of the first locking member inhibits or prevents counter-rotation of theretractable sheath 50, which in turn prevents theguide element 52 from shifting back into thefirst guide path 30 at intersection between thefirst guide path 30 and thesecond guide path 32. - As shown in
FIG. 8 , upon reaching theretractable sheath 50 reaching thedistal tip 44 of theneedle cannula 42, thesecond locking element 70 moves distally over the distal tip to cover thedistal tip 44 of the needle cannula 4 to prevent reuse of thesafety needle device 10. Theretractable sheath 50 has been fully extended and fully covers theneedle cannula 42. Thesecond locking element 70 thus presents a physical stop to inhibit theretractable sheath 50 from being proximally retracted again. -
Housing 20 couples toretractable sheath 50 to allowretractable sheath 50 to translate along and at least partially rotate about the axis. - Therefore, embodiments of the present disclosure utilize
guide element 52 on the retractable sheath traveling along afirst guide path 30,second guide path 32 andthird guide path 34 disposed insidehousing 20. Once injection begins, theguide element 52 on theretractable sheath 50 travels along the afirst guide path 30,second guide path 32 andthird guide path 34 rotating the retractable sheath from an initial position to a second position as it moves axially. Once rotation is completed, afirst locking element 60 comprising two locking tabs at the top of theretractable sheath 50 snap into ribs within thehousing 20. The two locking tabs serve to keepretractable sheath 50 from rotating back to the initial position ensuring that final lockout withsecond locking element 70 will occur. At this point, the user can continue to insert the needle to the desired depth in the patient and theretractable sheath 50 will move axially within the housing path. Upon removal of the needle cannula,spring element 90 within the system will push theretractable sheath 50 down thethird guide path 34 to a final position and thesecond locking element 70 will automatically cover thedistal tip 44 of theneedle cannula 42 thereby passively protecting the user from needle stick injury. - Stroke length is the sum of needle cannula length and
retractable sheath 50 lockout travel. The distance between proximal end ofretractable sheath 50 anddistal tip 44 ofneedle cannula 42 is a stack-up of tolerances and safety margin to insure needle stick injury (NSI) is prevented following use. - In one or more embodiments, overall length of the safety needle device may be reduced when the spring element is allowed to collapse inside both the
retractable sheath 50 andhousing 20. Thus reducing overall length by the solid height and subsequently lowering forces applied to a patient's skin. - In one or more embodiments, overall length of the safety needle device may also be reduced by using telescoping components.
- As shown in
FIG. 9 , in one or more embodiments, thesafety needle device 10 can include acap 100 that is removably coupled to thehousing 20 to reduce or prevent contamination of the needle cannula during shipping and storage of thesafety needle device 10. Thecap 100 is generally kept in the closed position until just prior to an injection and/or aspiration procedure, at which time thecap 100 removed from thehousing 20. In some embodiments,cap 100 is configured to assist in properly drawing a dose from a vial. - Any suitable caps or packaging comprising a safety feature may be used in conjunction with the safety needle device disclosed herein. Any suitable caps or packaging comprising a safety feature may be used in conjunction with the safety needle device disclosed herein. Types of safety features vary in structure and mechanics but exemplary caps or packaging include, but are not limited to, those described in commonly owned, U.S. Patent Application Ser. Nos. 62/433,044, 62/433,526 and 62,433,297, the disclosures of which are incorporated herein by reference in their entireties.
- Reference throughout this specification to “one embodiment,” “certain embodiments,” “various embodiments,” “one or more embodiments” or “an embodiment” means that a particular feature, structure, material, or characteristic described in connection with the embodiment is included in at least one embodiment of the disclosure. Thus, the appearances of the phrases such as “in one or more embodiments,” “in certain embodiments,” “in various embodiments,” “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily referring to the same embodiment of the disclosure. Furthermore, the particular features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments.
- Although the disclosure herein provided a description with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the disclosure. It will be apparent to those skilled in the art that various modifications and variations can be made to the present disclosure without departing from the spirit and scope thereof. Thus, it is intended that the present disclosure include modifications and variations that are within the scope of the appended claims and their equivalents.
Claims (12)
1. A safety needle device, comprising:
a housing configured to couple to a syringe, the housing having a proximal end, a distal end, and a housing body;
a first guide path, a second guide path and a third guide path disposed on the housing body, the second guide path intersecting the first guide path and the third guide path, the first guide path and the third guide path parallel to a central axis which extends along the housing;
a needle hub disposed on the proximal end of the housing;
a needle cannula attached to the needle hub;
a retractable sheath having a rotating cam configured to move between an initial position wherein the initial position partially exposes a distal tip of the needle cannula, a retracted position wherein the retracted position fully exposes the needle cannula and an extended position with respect to the housing wherein the extended position fully covers the distal tip of the needle cannula,
the first guide path and the second guide path disposed on the housing body configured to receive the rotating can, wherein the retractable sheath rotates with respect to the housing during movement from the initial position to the retracted position;
a first locking element comprising a tab on a distal end of the retractable sheath and a locking rib on the housing,
a second locking element;
the rotating cam disposed in the housing body; and
a spring element;
wherein movement of the retractable sheath from the initial position to the retracted position engages the locking rib of the housing to the tab on the distal end of the retractable sheath, thereby preventing further rotation of the rotating cam and thus preventing the guide member from returning to the first guide path;
wherein movement of the retractable sheath from the retracted position to the extended position engages the second locking element to a distal tip of the needle cannula, wherein the second locking element inhibits reuse of the safety needle device by inhibiting translation of the retractable sheath.
2. The safety needle device of claim 1 , wherein the rotating cam is a peg.
3. The safety needle device of claim 1 , wherein the first locking element is passively activated.
4. The safety needle device of claim 1 , wherein rotation of the retractable sheath from the initial position to the retracted position transfers the rotating cam of the retractable sheath from the first guide path on the housing to the third guide path on the housing via the second guide path.
5. The safety needle device of claim 1 , wherein the second locking element is passively activated.
6. The safety needle device of claim 1 , wherein the first locking element inhibits reuse of the safety needle device by inhibiting rotation of the retractable sheath.
7. The safety needle device of claim 1 , wherein the spring element biases the retractable sheath toward the extended position.
8. The safety needle device of claim 1 , wherein the retractable sheath translates from the initial position to the retracted position without impediment.
9. The safety needle device of claim 1 , wherein the needle cannula is obscured from view when the retractable sheath is in the extended position.
10. The safety needle device of claim 1 , wherein the spring element is a coil spring.
11. The safety needle device of claim 1 further comprising a metal latch disposed on the retractable sheath.
12. The safety needle device of claim 1 further comprising a cap removably coupled to the housing.
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AU2017375773A1 (en) | 2019-06-06 |
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