US20050027264A1 - Huber needle with anti-rebound safety mechanism - Google Patents

Abstract

A safety needle device is provided for protecting a user against needle-stick injuries. This needle device includes a needle housing having a distal housing opening. A needle is disposed within the needle housing and has a distal needle portion which extends away therefrom through the distal housing opening. An elongate sheath assembly surrounds the needle within the needle housing. A biasing member is engaged to the sheath assembly and is configured to apply a force thereupon towards the distal housing opening. The biasing member defines a centerline which is parallel to the needle's distal needle portion. An indexer is engaged to the biasing member and is operative to increase or decrease a spring force of the biasing member by rotating the indexer. A trigger member is engaged to the biasing member for retaining the sheath assembly within the needle housing against the force urging the sheath assembly towards the distal housing opening. The trigger member is sized and configured to release the biasing member. This allows the sheath assembly to transition towards and out of the distal housing opening via the force to thereby enclose the distal needle portion therewith.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• The present application is a continuation-in-part of U.S. patent application Ser. No. 10/688,119 entitled “HUBER NEEDLE WITH ANTI-REBOUND SAFETY MECHANISM” filed Oct. 17, 2003, which is a continuation-in-part of U.S. patent application Ser. No. 10/375,963 entitled “HUBER NEEDLE WITH ANTI-REBOUND SAFETY MECHANISM” filed Feb. 28, 2003, which is a continuation-in-part of U.S. patent application Ser. No. 10/350,765 entitled “HUBER NEEDLE WITH ANTI-REBOUND SAFETY MECHANISM” filed Jan. 24, 2003, which claims the benefit of U.S. Provisional Application No. 60/360,406 entitled “HUBER NEEDLE WITH ANTI-REBOUND MECHANISM” filed Feb. 28, 2002, the entirety of the disclosures of which are expressly incorporated herein by reference.
STATEMENT RE: FEDERALLY SPONSORED RESEARCH/DEVELOPMENT
• Not Applicable
BACKGROUND OF THE INVENTION
• The present invention relates generally to medical needle devices, and more particularly to an improved, passive safety needle device featuring a sheath assembly which is designed to be outwardly deployable and enclose the exposed portion of an affixed needle therewithin so as to protect its user against inadvertent needle-stick injuries.
• Needle-stick injuries are common and are of great concern in today's health-care industry. A vast majority of these injuries occur while withdrawing conventional Huber needles from implanted IV ports after administering medicants such as antibiotics or chemotherapy.
• More specifically, a great deal of force is required during Huber needle withdrawal to overcome the resistance of the port's septum. Since a non-dominant hand is typically used in this process to secure the implanted port, it often becomes stuck on the rebound of the Huber needle.
• Because a Huber needle is utilized for venous access, such needle-stick injury as described above presents a high risk for pathogen transmission. An exposed and/or injured health-care worker must be tested for various blood-borne pathogens such as hepatitis B, hepatitis C and HIV.
• Such testing is usually repeated to ensure that the exposed and/or injured health-care worker is not infected of those pathogens. As a further precaution, boosting of immunity may simultaneously take place as an additional insurance of safety.
• In order to alleviate the dangers associated with needle-stick injuries, some health-care workers have fashioned home-made guards to protect their non-dominant hands. However, these home-made guards are not user-friendly as the health-care workers must make the conscious choice to wear them every time an injection is made.
• The health-care workers may sometimes neglect to put them on because they are either inconvenient to use, interfere with the process of administering the Huber needle or the health-care workers may just simply forget to wear them. All of these factors contribute to negating the guards' effectiveness to protect the health-care workers against the dangers of needle-stick injuries.
• In view of the above-described shortcomings of conventional needle guards, there exists a need in the art for a safety needle guard which can protect health-care workers against the dangers of needle-stick injuries in a convenient and user-friendly manner. More specifically, there exists a need for a safety needle guard which can be automatically implemented in a user passive manner during the needle injection process so as to consistently protect the health-care workers against the dangers of needle-stick injuries.
BRIEF SUMMARY OF THE INVENTION
• The present invention specifically addresses and alleviates the above-referenced deficiencies associated with the use of the Huber needle guards of the prior art. More particularly, the present invention is an improved, passive safety needle device featuring a sheath assembly which is outwardly deployable relative to the exposed portion of its affixed needle. By such deployment, a physical barrier can be placed around the needle by the sheath assembly to protect a user from being inadvertently stuck by the needle, thus preventing needle-stick injuries and all the risks that are associated with them. Although this sheath assembly is intended to be used for Huber needle applications, it is specifically recognized herein that such sheath assembly may be used in conjunction with other types of conventional needle applications as well.
• In accordance with a preferred embodiment of the present invention, there is provided a passive safety needle device for protecting its user against a needle-stick injury. The safety needle device of the present invention first features a needle housing comprised of two substantially identical housing halves engaged to each other about their respective inner housing faces. Although such housing halves may be engaged in any manner or fashion, it is preferred that such engagement occurs through ultrasonic welding. Moreover, each of the two housing halves are preferably fabricated from a plastic material such as through the process of plastic injection molding.
• The needle housing includes an internal groove which is elongated therewithin and communicates with its distal opening. This groove is preferably elongated in a manner as to substantially correspond to (i.e., be complementary to) the general arcuate curvature of the needle housing's upper surface. In this respect, the internal groove defines a bend radius which is complementary in shape to the upper housing surface.
• In the preferred embodiment of the present invention, the needle housing further includes a needle, of which its intermediate portion is disposed within the elongated groove. In this regard, that portion of the needle is formed in an arcuate configuration to match the bend radius of the groove so it can be accommodated therewithin. The needle utilized with the present needle device is preferably a stainless steel Huber needle having a non-coring distal needle point.
• The needle defines a proximal needle portion which becomes exposed outside of the needle housing by extending through the needle housing's proximal opening. Flexible infusion tubing preferably made from silicone rubber and/or polyvinyl chloride or polyethylene surrounds this exposed proximal portion of the needle and connects to the needle housing through its proximal opening. The infusion tube or tubing can be maintained in this position by the engagement of the two housing halves which compress on the tubing.
• A distal portion of the needle is defined generally opposite to the proximal needle portion. The needle portion is retained outside of the needle housing as it is extended downward through the distal housing opening. The distal needle portion forms a needle point at its exposed end which is used for penetrating the patient's skin and accessing the implanted port.
• In the preferred embodiment, the needle housing has a lower housing surface that defines a lower housing recess. This recess is primarily intended for accommodating a hold-down platform. The hold-down platform may be engaged within the recess through a variety attachment procedures such as adhesive or fastener. By providing platform strips which radially extend outward from such location of engagement, the hold-down platform may be placed near the injection point and be used for securing the safety needle device upon the patient by means of taping over the platform strips and the patient's skin. Preferably, the hold-down platform has a generally circular or rectangular configuration, and is fabricated from either a rubber or plastic material.
• In accordance with a preferred embodiment of the present invention, an elongate sheath assembly is provided within the needle housing. More specifically, this sheath assembly is situated within the groove when disposed in a retracted position surrounding the intermediate portion of the needle. The sheath assembly has an axial length that is substantially identical to that of the elongated groove. Although the sheath assembly may be formed from various materials, it is preferably formed as an elongate wound stainless steel wire tube and/or semi-rigid polymer such as polyethylene or Teflon.
• The sheath assembly of the preferred embodiment defines a distal sheath end. Attached to this end is a distal tip component which preferably comprises a transparent plastic tip. The tip component can be either insert molded or adhered to the distal sheath end. The distal tip component forms a distal tip having a diameter which is generally greater than that of the groove but substantially equal to or less than the diameter of the distal housing opening.
• The sheath assembly further defines a proximal sheath end generally opposite to the distal sheath end. Attached to the proximal sheath end is a proximal tip component having a diameter which is generally greater than the diameter of the groove's distal opening. As will be discussed more fully below, such configuration allows the sheath assembly to stop once reaching the fully extended position, that is, the distal tip component being advanced over and beyond the distal needle point while enclosing the distal needle portion with the sheath assembly. Although other types of tip components may be contemplated, the proximal tip component utilized with the present invention is preferably formed as a stainless steel or plastic ferrule.
• In the preferred embodiment of the present invention, a biasing member is provided within the needle housing. This biasing member is used for passively moving the sheath assembly along the groove between the retracted and extended positions. The biasing member is connected between the proximal tip component and a knob member disposed on the exterior of the needle housing.
• The knob member allows the user to control the movement of the sheath assembly along the elongated groove. This is possible due to the mechanical connections with the proximal tip component of the sheath assembly and the biasing member. Because the preferred biasing member comprises a torsional biasing member which is configured to naturally urge the sheath assembly towards the extended position, the user may utilize the knob member to control the sheath assembly when moving along that direction. In the preferred embodiment, the biasing member comprises either a torsional arm or torsional spring. However, other types of biasing members are contemplated as they may also achieve the ultimate objective of passively deploying the sheath assembly outwardly with respect to the distal needle portion.
• In accordance with a second preferred embodiment of the present invention, a passive safety needle device of modified structure is disclosed herein. This specific safety needle device is essentially designed to perform the same function as that of the above-described needle device through the use of a modified structural configuration. More specifically, it utilizes a different type of proximal tip component at the proximal sheath end for moving the sheath assembly along the groove.
• In lieu of using a ferrule as the proximal tip component, the alternately configured needle device comprises a tip body which is preferably fabricated through plastic molding. Although other forms of attachment are contemplated herein, the tip body is preferably barb fitted through the proximal sheath end of the sheath assembly. This enables the tip body to be fixedly secured to the sheath assembly which allows it to transition along the groove when the tip body is urged by the biasing member (e.g., torsion spring) to move therealong.
• The tip body is releasibly mounted upon a trigger member which is structurally configured to be elongated from within the needle housing to the outside thereof. In particular, the tip body is designed to maintain the sheath assembly in the retracted position against the force of the biasing member. To accomplish this, the trigger member extends a tip retaining projection through the tip body from its end which is disposed within the needle housing. Its opposite end is exposed through the needle housing and serves as a trigger mechanism for passively moving the tip body, and hence the sheath assembly, from the retracted position to the extended position. More particularly, the trigger member maintains the tip body and the sheath assembly in the retracted position until the tip body is manually released from the tip retaining projection. Such release of the tip body is performed by pressing the exposed end of the trigger member towards the needle housing. This causes the tip retaining projection to slip out from the tip body and free the tip body from its holding. Due to its connection with the biasing member which applies force towards the extended position, the tip body is automatically caused thereby to be moved in that direction, hence effectuating the same directional movement of the sheath assembly as well.
• Similar to the above-described proximal tip component, the tip body possesses a body size which is substantially larger than the distal opening of the groove. This allows the tip body to stop once reaching and abutting the portion of the groove forming the narrowed distal opening. Upon reaching such positioning, the sheath assembly should now be deployed outside of the needle housing and be extended over the entirety of the needle's distal portion, including its tip. The sheath assembly is projected to remain outwardly deployed since the spring force applied by the biasing member would urge the tip body against the converged portion of the groove which forms its distal opening.
• In accordance with a third preferred embodiment of the present invention, a different version of the passive safety needle device is described herein. This version of the safety needle device is also designed to perform the same function as the needle devices of the first and second embodiments. However, the third embodied needle device employs the use of a wholly different sheath releasing concept in doing so. More particularly, it eliminates the need for any type of proximal tip component such as a ferrule (as used in the first preferred embodiment) or a tip body (as used in the second preferred embodiment) at the proximal sheath end for retaining, releasing and moving the sheath assembly along the groove.
• Rather, the safety needle device of the third embodiment utilizes an extension of its biasing member (e.g., torsional arm) to connect directly to the proximal end of the sheath assembly. Specifically, such extension extends out from the biasing member substantially parallel to the inner housing surfaces of the needle housing. Upon reaching the proximate location of the proximal sheath end, an end portion of the biasing member's extension is curved or bent toward the proximal sheath end, preferably forming a generally perpendicular relationship with the inner housing surfaces. That end portion is then ultimately connected through the proximal sheath end of the sheath assembly.
• In particular, the extension's end portion is inserted through one side of the proximate sheath end and is allowed to come out of the generally opposing side thereof. This allows the extension to be connected to the proximate sheath end, thereby placing the biasing member in mechanical connection with the sheath assembly. Preferably, the end portion of the extension is curved or bent backward in the general direction of the biasing member so as to prevent it from inadvertently slipping out or disconnecting from the proximal sheath end unless the proximal sheath end somehow becomes torn or ruptured.
• Similar to the second embodiment, the safety needle device of the third embodiment utilizes a trigger member for retaining and releasing the sheath assembly. Like the version described in the second embodiment, the trigger member utilized in the third embodiment has one end disposed within the needle housing and an opposite end disposed outside the needle housing. Essentially, this trigger member is also operative to release the retained sheath assembly via pressing the exposed outside end thereof towards the needle housing. Upon such action, the torsional force of the biasing member causes the sheath assembly to be automatically moved toward the extended position.
• However, the tip retaining projection formed adjacent the internally located end of the trigger member is structurally different from the version illustrated in the second embodiment. In particular, the tip retaining projection directly engages the end portion of the biasing member's extension when the extension and proximal sheath end are retracted back in the retracted position. More particularly, the tip retaining projection of the third embodiment extends upward and away from the internally located end of the trigger member.
• Formed at the projected end of the tip retaining projection is its engaging portion which directly engages the end portion of the biasing member. The engaging portion is positioned generally perpendicular to the projected end of the tip retaining projection and comprises a notch which faces toward the trigger member. This notch is used for releasibly engaging the end portion of the biasing member's extension until the trigger member is manually pressed. More specifically, the notch of the engaging portion preferably hooks a section of the extension's end portion which is defined either prior or subsequent to the insertion into proximal sheath end. In the preferred embodiment, the notch has a smooth and continuous surface so that the extension's end portion may be easily dislodged therefrom when the trigger member is pressed inward by the user's finger, hence deploying the sheath assembly outside the needle housing.
• Upon the outward deployment of the sheath assembly, the proximate sheath end is designed to stop once reaching the distal opening of the needle housing's groove. This is possible because the extension of the biasing member will come in contact with the lower inner housing surface of the needle housing and be forced to stop its movement upon such contact. Due to its engagement to the proximal sheath end, the extension in turn forces the proximal sheath end to stop its movement about the distal opening. This results in the sheath assembly to be deployed outside the needle housing and be extended over the entirety of the needle's distal portion, including its tip. The sheath assembly should remain outwardly deployed as the spring force of the biasing member urges the extension tightly against the lower inner housing surface of the needle housing.
• The operation of the safety needle device of the first embodiment is described herein to illustrate the operation of the safety needle device of the second and third embodiments as well. The safety needle device of the first embodiment is designed to protect a user from inadvertent needle stick during withdrawal of the needle from the patient. More specifically, the distal needle point is first injected into a designated skin area of the patient to access the implanted IV port. By such penetration, various tasks such as delivering fluids and medications, drawing blood for diagnostic testing and/or infusing blood products may be conducted. Optionally, the needle device can be secured in place by taping its platform strips to the patient's surrounding skin area.
• After performing any one of the tasks as described above, the needle is withdrawn from the patient. While withdrawing the needle, the sheath assembly is deployed outwardly and passively from within the needle device relative to the distal needle portion resulting in the distal needle portion being completely enclosed and/or surrounded by the outwardly deployed sheath assembly. Such process can be facilitated by using the externally located knob member which allows the user to control the outward deployment of the sheath assembly. In the case of the second or third embodied safety needle device, the trigger member can be manually pressed inward to automatically trigger the outward deployment of the sheath assembly.
• The needle device is then ready for proper disposal in a Sharps container or other container designated for used medical devices.
• In accordance with a fourth preferred embodiment of the present invention, a passive safety needle device is described hererin. In particular, the device has similar construction compared to the devices of the first through third embodiments. However, the device of the fourth preferred embodiment is different in that it reorients the biasing member and further includes an indexer. In the fourth preferred embodiment, the biasing member is oriented such that its centerline is parallel with the needle's distal needle portion, whereas the centerlines of the prior embodiments' biasing members are perpendicular to their respective needle's distal needle portion. This reorientation of the biasing member enables a longer protective sheath to be inserted into an internal arcuate groove such that a longer needle compared to the previously discussed embodiments may be covered by the protective sheath.
• With respect to the indexer, the same is capable of adjusting a spring force of the biasing member. In particular, the indexer may have a cylindrical configuration. The indexer may be attached to the housing and the biasing member such that rotating the indexer is operative to increase or decrease the spring force of the biasing member.
BRIEF DESCRIPTION OF THE DRAWINGS
• These as well as other features of the present invention will become more apparent upon reference to the drawings wherein:
• FIG. 1 is a perspective view of a safety needle device constructed in accordance with a preferred embodiment of the present invention and illustrating its needle housing having generally rectangular platform strips radially extending outward therefrom;
• FIG. 2 is a perspective cross-sectional view of the safety needle device ofFIG. 1 and illustrating the manner in which a sheath assembly is extended from within its needle housing;
• FIG. 3 is a side cross-sectional view of the safety needle device ofFIG. 1 illustrating the manner in which a sheath assembly is retracted within its needle housing;
• FIG. 4 is a side view of the safety needle device ofFIG. 1 and illustrating a needle's exposed distal portion which extends downward out of its needle housing;
• FIG. 5ais a top view of the safety needle device ofFIG. 1 illustrating the flexible infusion tubing which is connected through a proximal opening of its needle housing;
• FIG. 5bis an enlarged view of the encircled portion ofFIG. 5a, illustrating a proximal notch which is used for retaining a sheath assembly in a retracted position;
• FIG. 6ais a front view of the safety needle device ofFIG. 1 illustrating a needle's distal portion which is disposed generally perpendicular to the radially extending platform strips;
• FIG. 6bis an enlarged view of the encircled portion ofFIG. 6a, illustrating a distal notch which is used for securing a sheath assembly in an extended position;
• FIG. 7ais a side view of a needle having a bent intermediate portion which corresponds to the configuration of an elongate groove formed within the needle housing ofFIG. 1;
• FIG. 7bis a partial side view of the needle ofFIG. 7aand illustrating its distal portion which defines a non-coring pointed end;
• FIG. 8ais a front perspective view of a torsional arm which is used for moving the sheath assembly ofFIGS. 2 and 3 between the retracted and extended positions;
• FIG. 8bis a top view of the torsional arm ofFIG. 8aand illustrating the direction in which it bends when being inserted within proximal and distal notches of the needle housing;
• FIG. 8cis a side view of the torsional arm ofFIG. 8aillustrating the direction in which it bends when the sheath assembly is moved between the retracted and extended positions;
• FIG. 9ais a side view of one housing half which is used to form the needle housing ofFIG. 1 when engaged with the other housing half;
• FIG. 9bis a perspective view of the housing half ofFIG. 9aillustrating pegs formed about an inner housing face thereof;
• FIG. 9cis a top view of the housing half ofFIG. 9aillustrating its upper housing surface forming a proximal notch;
• FIG. 9dis a rear view of the housing half ofFIG. 9aillustrating its side housing surface forming finger-graspable projections;
• FIG. 10 is a perspective cross-sectional view of the sheath assembly ofFIGS. 2 and 3 illustrating its proximal and distal tip components;
• FIG. 11 is a perspective view of the safety needle device ofFIG. 1 and illustrating its needle housing which uses generally half-circular platform strips as an alternative to the generally rectangular platform strips;
• FIG. 12 is a side cross-sectional view of the safety needle device ofFIG. 11 illustrating the use of a torsional spring as an alternative to the torsional arm;
• FIG. 13 is an exploded perspective view of a safety needle device constructed in accordance with a second preferred embodiment of the present invention and illustrating its needle housing having generally half-circular platform strips extending outwardly therefrom;
• FIG. 14 is a side view of the safety needle device ofFIG. 13 and illustrating the manner in which its tip body is barb fitted through an end of the sheath assembly;
• FIG. 15 is a perspective view of the safety needle device ofFIG. 13 and illustrating its trigger member which retains the tip body and the sheath assembly in a retracted position;
• FIG. 16 is a perspective view of the safety needle device ofFIG. 13 and illustrating its needle housing which portrays an alternate outer configuration than the one shown inFIG. 13;
• FIG. 17 is an exploded perspective view of a safety needle device constructed in accordance with a third preferred embodiment of the present invention and illustrating its needle housing which includes a layer of padding thereunder;
• FIG. 18 is a side view of the safety needle device ofFIG. 17 and illustrating the manner in which its biasing member is engaged through an end of the sheath assembly;
• FIG. 19 is a perspective view of the safety needle device ofFIG. 17 and illustrating its trigger member which retains the biasing member and the sheath assembly in a retracted position;
• FIG. 20 is an exploded perspective view of a safety needle device constructed in accordance with a fourth preferred embodiment of the present invention and illustrates a centerline of a biasing member being parallel with a needle's distal needle portion (i.e., a biasing member rotated ninety (90) degrees compared to the biasing members of the devices of the first through third preferred embodiments of the present invention);
• FIG. 21 is an assembled perspective view of the device ofFIG. 20 and illustrates the protective sheath in a retracted position;
• FIG. 22 is an assembled perspective view of the device ofFIG. 20 and illustrates the protective sheath in an extended position;
• FIG. 23 is an assembled perspective view of the device ofFIG. 20 and illustrates the trigger member in a first position and the catch in a retain position;
• FIG. 24 is an assembled perspective view of the device ofFIG. 20 and illustrates the trigger member in a second position, the catch in a release position and a protective sheath covering the needle tip;
• FIG. 25 is a top view of the device ofFIG. 20;
• FIG. 26 is a cross sectional view of the device ofFIG. 20 and illustrates that an indexer is engaged to a housing and biasing member; and
• FIG. 27 is a transverse cross sectional view ofFIG. 20 with respect toFIG. 26.
DETAILED DESCRIPTION OF THE INVENTION
• Referring now to the drawings wherein the showings are for purposes of illustrating preferred embodiments of the present invention only, and not for purposes of limiting the same,FIG. 1 illustrates a passivesafety needle device10 constructed in accordance with a preferred embodiment of the present invention. As indicated above, the presentsafety needle device10 features asheath assembly12 which is outwardly deployable with respect to thedistal needle portion14, that is, the exposed portion of its affixedneedle16 which is used to access an IV port implanted underneath a patient's designated skin area (not shown).
• As will be soon discussed, such passive deployment of thesheath assembly12 provides a tangible physical barrier around thedistal needle portion14 to protect a user from being inadvertently stuck by theneedle16, thereby preventing needle-stick injuries and all the risks associated therewith. Although thesheath assembly12 is preferably used for Huber needle applications, it is expressly contemplated herein thatsuch sheath assembly12 may be used for other types of conventional needle applications as well.
• Referring more particularly toFIGS. 1 and 9a-9c, thesafety needle device10 includes aneedle housing18. Although thisneedle housing18 may be formed from a unitary construction, it is preferably constructed from two substantiallyidentical housing halves20,22 which are assembled to each other about their respective inner housing faces24. Thefirst housing half20 includes at least onepeg26 that can be retained within at least one corresponding aperture (not shown) provided on thesecond housing half22. The permanent engagement between the twohousing halves20,22 is preferably accomplished with adhesive or ultrasonic welding or snap fit engagement.
• The two substantiallyidentical housing halves20,22 may be fabricated from any rigid material. However, the material of choice is a polymer (i.e., plastic). In this respect, the manufacture of eachhousing half20 or22 may be greatly expedited through utilizing the process of plastic injection molding techniques.
• Referring now toFIGS. 9dand11, the exterior of theneedle housing18 preferably includesplural projections30 to ease in the handling of the presentsafety needle device10. Theseprojections30 may be formed on one or bothsides32 of theneedle housing18. As can be seen from the specified figures, the finger-graspable projections30 may be provided as a group of linearly configured projections (as shown inFIG. 9d) or arcuately configured projections (as shown inFIG. 11).
• As shown inFIGS. 2 and 4, theneedle housing18 includes an internalarcuate groove34 which initiates intermediate the housing and extends to adistal opening36 of theneedle housing18. Preferably, thegroove34 is formed in a generally complementary configuration to the general arcuate curvature of the needle housing'supper surface38. As such, theinternal groove34 has a bend radius which closely simulates the bend radius of theupper housing surface38.
• The needle housing also contains aneedle16, of which anintermediate portion40 thereof is disposed within theelongated groove34. Theintermediate needle portion40 is sufficiently formed (i.e., bent to closely match the bend radius of theinternal groove34 so as to be accommodatingly disposed therewithin). Theneedle16 preferably used with the presentsafety needle device10 comprises a stainless steel Huber needle. However, other types of needles such as a conventional hypodermic syringe needle may be workable with the presentsafety needle device10. Preferably, theneedle16 has aneedle point42 which is non-coring but use of the coring needle point may be contemplated. Of course, theneedle point42 is intended for penetrating a designated area of the patient's skin and accessing an IV port implanted underneath.
• FIGS. 2 and 3 show aproximal needle portion44 of theneedle16. Theproximal needle portion44 is exposed outside of the needle housing19 by extending through aproximal opening46 thereof. Thisneedle portion44 is connected to a flexible infusion tube ortubing48, in oneend50 of which is rigidly connected to theneedle housing18 through itsproximal opening46. The other end (not shown) of the infusion tubing is typically placed in communication with a conventional syringe or an infusion pump (not shown).
• Referring specifically toFIGS. 9aand9b, needle-retainingprojections52 are preferably formed adjacent theproximal opening46. Theseprojections52 provide an interference and mechanical lock on thetubing48 when the twohousing halves20,22 are assembled. Moreover, the portion of theneedle16 which lies between thegroove34 and theproximal opening46 may be secured in place through the use of afitting track54 or adhesive.
• As shown inFIGS. 3 and 7a-7b, adistal needle portion14 is provided generally opposite to theproximal needle portion44. Thedistal needle portion14 is exposed outside of theneedle housing18 extending downwardly through thedistal housing opening36. As briefly mentioned above, thisportion14 forms aneedle point42 at its exposed end which is used for penetrating the patient's skin and accessing the implanted subcutaneous IV port.
• Referring now toFIGS. 1, 2,6aand11, theneedle housing18 has alower housing surface56 which defines arecess58 underneath. Thislower housing recess58 is utilized for accommodating a hold-down platform60. More specifically, the hold-down platform60 is maintained within therecess58 by various conventional attachment means (i.e., adhesive, fasteners, or the like).
• The hold-down platform60 features at least two platform strips62 which radially extend out from theneedle housing18. In this respect, the platform strips62 are disposed in a manner as to form a generally perpendicular relationship with thedistal needle portion14. The hold-down platform60 is primarily used to secure thesafety needle device10 upon the patient while infusion takes place by means of taping over the platform strips62 and the patient's skin. Theplatform60 may be fabricated from any rigid or semi-rigid material such as plastic or rubber. In one configuration, the hold-down platform60 is formed having a generally circular configuration (best shown inFIG. 11). In the other configurations, it is formed having a generally rectangular configuration (best shown inFIG. 1).
• FIGS. 2, 3 and10-12 depict an elongate sheath assembly64 and illustrates its ability to move from within to and out of theneedle housing18. In particular, the elongate sheath assembly64 is disposed in a retracted position designated by the numeral66 within theinternal groove34 of theneedle housing18 in a manner as to surround theintermediate needle portion40. The assembly64 has a longitudinal length that is substantially equal or somewhat longer than the arcuate length of theinternal groove34. Obviously, the sheath assembly64 has a diameter which is less than that of thegroove34 so as to allow its axial movement therewithin. Although the sheath assembly64 may be formed from various materials, it is preferably made from an elongated wound wire constructed of stainless steel (as shown inFIG. 10).
• The sheath assembly64 includes adistal end68 which mounts to adistal tip component70. Preferably, thedistal tip component70 is fabricated from a plastic, preferably transparent, material. However, thedistal tip component70 should in no way be limited to such construction as other forms of rigid or semi-rigid tips (e.g., metal or rubber tips) may be used in lieu thereof. Thedistal tip component70 is attached to thedistal sheath end68 either through the process of insert molding or adhesive. Thetip component70 may include adistal tip72 having a diameter size generally greater than that of the groove'sdistal opening78, but substantially equal to or lesser than the diameter of the distal housing opening36 (as shown inFIG. 3). Alternatively, the diameter of thedistal tip72 may be sized to be somewhat similar to the diameter of the distal groove opening78 (as shown inFIG. 11).
• The sheath assembly64 further includes aproximal sheath end74 which is located generally opposite to thedistal sheath end68. Aproximal tip component76 is attached to theproximal sheath end74. Similar to thedistal tip component70, theproximal tip component76 can be attached via insert molding or adhesive. Thetip component76 has a diameter size which is generally greater than the diameter of the groove'sdistal opening78. Such diameter size of theproximal tip component76 facilitates stopping the sheath assembly64 once it has reached its fully extended position designated generally by the numeral80 (i.e., thedistal tip component70 being advanced over and beyond thedistal needle point42 while enclosing thedistal needle portion14 with the sheath assembly64). Although other types of tip components may be used, theproximal tip component76 is preferably fabricated as a stainless steel or plastic ferrule.
• Referring now toFIG. 2, 3,8a-8cand12, theneedle housing18 includes a biasingmember82 therewithin. This biasingmember82 is secured in place within its allocatedtrack84 which prevents it from bending. Ablind hole86 is also provided as a further insurance in securing the biasingmember82. Cored-outpockets88 are defined about the biasingmember82 in order to maintain a constant wall thickness. Atop projection90 is also provided on each of thehousing halves20,22 to resist squeezing thetrack84 together and to prevent the free movement of the biasingmember82 when removing theneedle16 from the patient. The biasingmember82 is used for moving the sheath assembly64 along thegroove34 between the retracted andextended positions66,80. This can be accomplished through its engagement to theproximal tip component76 and to an outwardly exposedknob member92.
• Theknob member92 is provided external to theneedle housing18 and allows the user to manually and passively control the movement of the sheath assembly64 along the elongatedinternal groove34.
• More specifically, anextension94 of the biasingmember82 is connected to a recess96 (shown inFIG. 10) formed on theproximal tip component76. The biasing member'sextension94 forms acircular bend portion95 which extends around the proximal tip component'srecess96. Theextension94 further extends out and attaches to theknob member92 via insert molding or adhesive. Due to the torsional spring property of biasingmember82 which naturally urges the sheath assembly64 toward theextended position80, the user may utilize theknob member92 to control the sheath assembly64 when passively moving from its retracted to extended position.
• The biasingmember82 is preferably fabricated from a resilient material such as stainless spring steel or Nitinol. Due to such elastic nature, theextension94 of the biasingmember82 is capable of bending vertically when the sheath assembly64 is moved between the retracted andextended positions66,80 (best shown inFIG. 8c). As illustrated inFIG. 8b, it can even bend sideways when theextension94 is snapped into the proximal notch98 (for maintaining the retracted position66) or into the distal notch100 (for maintaining the extended position80). The biasingmember82 used with the presentsafety needle device10 can take the form of a torsional arm or a torsional spring.
• Referring now toFIGS. 13 and 16, there is shown a passivesafety needle device110 which is constructed in accordance with a second preferred embodiment of the present invention. The alternately embodiedsafety needle device110 is essentially designed to perform the same function as that of the above-describedneedle device10, that is, to passively extend itssheath assembly122 over thedistal portion114 of the needle116 (i.e., Huber needle), and hence provide effective protection against dangers of needle-stick injuries. However, it accomplishes such objective through a structural configuration which is somewhat different than the one disclosed above.
• First, although thesafety needle device110 of the second embodiment may utilize a similar oridentical needle housing18 as described above, it may alternatively display its own unique type ofneedle housing118 which is aesthetically different therefrom.Such needle housing118 is exemplified inFIG. 16 and as can be seen from that figure, its outer shape or configuration is substantially similar as its counterpart shown inFIG. 11. One major difference between them, however, is that theneedle housing118 ofFIG. 16 eliminates the need for any finger-graspable projections30 and rather provides a substantially continuous and smooth outer surface in lieu thereof. Furthermore, theneedle housing118 is preferably fabricated from a plastic material and may optionally characterize a transparent or semi-transparent body.
• As illustrated inFIGS. 14 and 15, thesafety needle device110 of the second embodiment additionally utilizes a different type ofproximal tip component126 for passively moving thesheath assembly122 out of thegroove124 and over theneedle116. Instead of using a ferrule as theproximal tip component76, the alternativesafety needle device110 utilizes a specially manufacturedtip body126 in its place (best shown inFIG. 15). Although thistip body126 may be fabricated from any rigid material, it is preferably made through plastic molding.
• Thetip body126 is attached to thesheath assembly122 at itsproximal sheath end128. It is contemplated herein that thetip body126 may become attached to theproximal sheath end128 by various methods of attachment such as fastening or adhering. Preferably, however, thetip body126 is attached through barb fitting method. More particularly, thetip body126 defines a tip protrusion130 which is extended through and pressed into theproximal sheath end128 of thesheath assembly122. Such barb fitting of the tip protrusion130 into the proximal sheath end enables thetip body126 to be securely affixed to thesheath assembly122 thereat. This in turn allows thesheath assembly122 to passively transition along thegroove124 and be deployed outside of theneedle housing118 when thetip body126 is caused to move in that direction by the biasingmember132 that it is connected to. Although other types of biasingmembers132 such as a torsional arm may be utilized for this purpose, it is preferred that a torsional spring is used as the biasingmember132 of the alternately embodied safety needle device110 (shown inFIG. 15).
• The specially manufacturedtip body126 is releasibly mounted upon atrigger member134 which is specifically designed for the purpose of retaining and releasing thetip body126. In order to accomplish such objective, thetrigger member134 possesses a structural configuration which is sufficient to be elongated from within theneedle housing118 to the outside thereof. Although thetrigger member134 may be variously configured and/or shaped, it is preferably elongated in a bar-like configuration. Such configuration of thetrigger member134 facilitates in maintaining thetip body126 in place against the spring force applied by the biasingmember132.
• More specifically, thetrigger member134 includes atip retaining projection136 which is adapted to engage anopening138 formed through thetip body126. Thisprojection136 is formed adjacent aninner end140 of thetrigger member134 which is disposed within theneedle housing118. Thetip retaining projection136 extends from about theinner end140 of thetrigger member134 towards anouter end142 thereof where it engages theopening138 of thetip body126 mounted therebetween.
• As briefly mentioned above, theouter end142 of thetrigger member134 is exposed through theneedle housing118 and serves as a trigger mechanism for moving thetip body126 toward thedistal opening144 of thegroove124. Due to its barb fitting arrangement with thesheath assembly122, the movement of thetip body126 effectuates the passive movement of thesheath assembly122 from the retractedposition146 to the extended position (not shown).
• The manner of repositioning thesheath assembly122 to the extended position is accomplished through the release of thetip body126 from thetrigger member134. Essentially, thetip retaining projection136 of thetrigger member134 maintains thetip body126 and thesheath assembly122 in the retractedposition146 until thetip body126 is manually released from thetrigger member134. This automatically triggers thetip body126 and thesheath assembly122 to move towards the extended position. Such release of thetip body126 is performed by manually pushing in theouter end142 of thetrigger member134 towards theneedle housing118. This causes thetip retaining projection136 to slip out from theopening138 and free thetip body126 from its holding.
• Because the biasingmember132 is mechanically connected to thetip body126 to apply a spring force toward thedistal opening144 of thegroove124, thetip body126 is automatically caused by the biasingmember132 to be urged in that direction and form the extended position. Due to its barb fitting connection with theproximal sheath end128, thetip body126 pushes thesheath assembly122 towards thedistal opening144 of thegroove124. This effectuates thesheath assembly122 to be passively deployed outside of theneedle housing118 and form the extended position with respect to thedistal portion114 of theneedle116.
• Similar to the above-describedproximal tip component76, thetip body126 possesses a body size which is substantially larger than thedistal opening144 of thegroove124. Because of its larger body size, thetip body126 is forced to stop once it reaches and abuts the portion of thegroove124 which converges inwardly to narrow thedistal opening144 thereof. However, the size of thedistal opening144 is sufficiently large enough to allow thesheath assembly122 to pass therethrough and be deployed outside of theneedle housing118 to extend over the entirety of thedistal needle portion114. Thesheath assembly122 remains in this outwardly deployed configuration as the spring force of the biasingmember132 continuously urges thetip body126 against the converged portion of thegroove124 which forms its narroweddistal opening144.
• Referring now toFIGS. 17 and 19, there is shown another passivesafety needle device150 which is constructed in accordance with a third preferred embodiment of the present invention. The passivesafety needle device150 of the third embodiment is essentially a modified version of the previously definedneedle devices10,110 and is designed to perform the same function (i.e., deter needle-stick injuries). However, as will be explained below, a different sheath releasing concept is employed for covering theneedle152 in order to protect its users against the dangers of needle-stick injuries.
• But prior to describing the specifics of such unique sheath releasing concept, it should be briefly pointed out herein that theneedle housing154 of the third embodiedsafety needle device150 may optionally comprise a layer ofpadding156 underneath so as to increase its user-friendliness (e.g., provide softening cushion upon user's chest) during needle applications. However, this is strictly an optional feature, and is not absolutely necessary as exemplified in thesafety needle devices10,110 of the first and second embodiments.
• In particular, the layer ofpadding156 is attached underneath aplatform158 of theneedle housing154 and further conforms to the configuration thereof. Preferably, it is adhered thereto via an adhesive (e.g., glue or bond) but a person of ordinary skill in the art will contemplate that other types of attachment means may be used instead. Although various materials may be used to fabricate this layer ofpadding156, it is preferably made from a foam material, and more preferably a closed-cell foam material.
• Turning now to the additional uniqueness of the third embodiment,FIGS. 18 and 19 show an overall sheath releasing mechanism which specifically eliminates the need for any type ofproximal tip component76 such as a ferrule (as used in the first preferred embodiment) or a tip body126 (as used in the second preferred embodiment). More specifically, thesafety needle device150 of the third embodiment is capable of retaining, releasing and moving thesheath assembly160 along the needle housing'sgroove162 without using those components at theproximal sheath end164.
• Instead, the passivesafety needle device150 of the third embodiment operates to move thesheath assembly160 from a retractedposition166 to an extended position168 directly with its biasingmember170, preferably a torsional arm. More specifically, this biasingmember170 forms an extension172 which extends outwardly therefrom in a substantially parallel relationship with respect to theinner housing surfaces174 of the needle housing towards theproximal end164 of thesheath assembly160. Upon reaching the proximate location of theproximal sheath end164, anend portion176 of the extension172 is curved or bent generally perpendicular with respect to theinner housing surfaces174 toward theproximal sheath end164. The extension'send portion176 is then connected through theproximal sheath end164.
• More specifically, theend portion176 of the extension172 becomes connected to theproximal sheath end164 by being inserted through one particular side of theproximate sheath end164. Although theend portion176 may be retained within theproximal sheath end164 for connection, it is preferably inserted all the way therethrough so as to extend out of the generally opposing side of theproximal sheath end164. Theend portion176 of the extension172 is then curved or bent backward in the general direction of the biasingmember170. This helps to prevent theend portion176 from unintentionally slipping out or disconnecting from theproximal end164 of thesheath assembly160 unless thatend164 becomes torn or ruptured. In this manner, the biasingmember170 and thesheath assembly160 become mechanically connected with each other.
• As specifically illustrated inFIG. 19, thesafety needle device150 of the third embodiment also employs the use of atrigger member178 for retaining and releasing thesheath assembly160. Similar to the version used in the second embodiment, thetrigger member178 utilized in the third embodiment has aninner end180 disposed within theneedle housing154 and anouter end182 disposed outside thereof. Likewise, thistrigger member178 is also operative to release the retractedsheath assembly160 when the user presses the exposedouter end182 towards theneedle housing154. Upon such manual activation, the torsional force produced by the biasingmember170 inevitably causes thesheath assembly160 to automatically slide along thegroove164 and form the extended position168 over theneedle152.
• FIG. 19 further shows atip retaining projection184 which is formed adjacent theinner end180 of thetrigger member178. As can be seen from that figure, thetip retaining projection184 utilized in the third preferred embodiment is structurally different from its counterpart version used in the second embodiment. Such structurally distinguishable features allow thetip retaining projection184 to directly engage theend portion176 of the biasing member's extension172 when the extension172 andproximal sheath end164 are maintained in the retractedposition166.
• Thetip retaining projection184 utilized in the third embodiment extends upward and away from theinner end180 of thetrigger member178. At the end of such extension, thetip retaining projection184 defines a projected end186 forming anengaging portion188 which corresponds to theend portion176 of the extension172 and directly engages therewith. Specifically, this engagingportion188 is in general perpendicular disposition relative to the projected end186 of thetip retaining projection184 and further comprises anotch190 which faces or opens up toward thetrigger member178. Thenotch190 is used for releasibly engaging theend portion176 of the biasing member's extension172 until thetrigger member178 is manually pressed toward theneedle housing154.
• Preferably, thenotch190 of the engagingportion188 is designed and used to hook a section of the extension'send portion176 which is defined either prior or subsequent to the insertion intoproximal sheath end164. To facilitate the release of the extension172, thenotch190 is formed of a smooth and continuous surface so as to allow the extension'send portion176 to be easily dislodged therefrom without being caught or interfered by any surface configuration.
• Upon the dislodging of theend portion178, thesheath assembly160 is caused to be outwardly deployed. Theproximate sheath end164 is designed to stop once reaching thedistal opening192 of the needle housing'sgroove162. More specifically, theproximal sheath end164 is inevitably stopped in such position as the extension172 of the biasingmember170 comes in contact with the lowerinner housing surface194 of theneedle housing154. Such contact of the extension172 would forcibly stop the sliding movement of thesheath assembly160 along thegroove162.
• Due to the engagement of the extension172 with theproximal sheath end164, the extension172 in turn forces thesheath assembly160 to stop its movement when theproximal sheath end164 reaches about thedistal opening192 of thegroove162. Such specified configuration results in thesheath assembly160 to be deployed outside theneedle housing154 and be extended over the entirety of theneedle152. Of course, theassembly160 should be sufficiently sized and elongated to cover the entirety of the exposedneedle152. Thesheath assembly160 should remain outwardly deployed in that position since the spring force of the biasingmember170 urges its extension172 tightly against the lowerinner housing surface194 of theneedle housing154.
• With the structure defined, the operation of thesafety needle device10 of the first embodiment is described herein to essentially illustrate the operation of thesafety needle device110 of the second and third embodiments as well. Thesafety needle device10 of the first embodiment is designed for the purpose of protecting a user from getting stuck when withdrawing theneedle16 from the patient. Initially, a user grabs the exterior of the housing having the distal needle point extending downwardly therefrom. Thedistal needle point42 is then inserted into a designated skin area of the patient to access the implanted IV port. By such penetration, various tasks such as delivering fluids and medications, drawing blood for diagnostic testing and/or infusing blood products may be conducted. Optionally, thesafety needle device10 of the present invention can be secured in place by taping its radially extending platform strips62 to the patient's surrounding skin area.
• After performing any one of the tasks as described above, theneedle16 is withdrawn from the patient. While withdrawing theneedle16, the externally disposedknob member92 is manipulated by the user to manually control the outward deployment of the sheath assembly64 from its retractedposition66 to itsextended position68. Such movement is further facilitated by thetorsional spring82. When the sheath assembly64 travels to itsextended position68, the sheath surrounds and covers the distal needle portion and needle tip thereby preventing any inadvertent needle stick to the user. In the case of the safety needle device of the second orthird embodiment110 or150, the outward deployment of thesheath assembly122 or160 can take place by the manual pressing of thetrigger member134 or178 which automatically triggers such deployment to occur.
• Thesafety needle device10 of the present invention is then ready for proper disposal. Preferably, the usedsafety needle device10 is thrown away in a Sharps container which is designated for used medical devices.
• Referring now toFIGS. 20-27, there is shown another passivesafety needle device200 which is constructed in accordance with a fourth preferred embodiment of the present invention. The passivesafety needle device200 is essentially a modified version of the previously definedneedle devices10,110,150. It is designed to deter needle stick injuries much like the previously definedneedle devices10,110,150. However, the orientation of the biasing member202 (seeFIG. 20) is rotated ninety (90) degrees compared to the biasingmembers82,132,170 of the first through third embodiments. The benefits of this altered orientation of the biasingmember202 is two fold: first, thedevice200 has a lower profile compared to the previously definedneedle devices10,110,150; and second, the device of the fourth preferred embodiment is able to protect the patient from a needle stick injuries from distal needle portion206 (seeFIG. 21) that is longer compared to thedistal needle portions14,114 in the previously defined needle devices.
• FIG. 21 illustrates an assembled view of thedevice200 of the fourth preferred embodiment. As can be seen fromFIG. 21, thedevice200 comprises ahousing208. Thehousing208 is comprised of anupper half210, alower half212, and abody214, as shown inFIG. 21. As shown inFIG. 20, thebody214 has formed therein an internalarcuate groove216 which may follow the configuration of the housing's outside peripheral surface218. Disposed within the internalarcuate groove216 is theneedle204 and theprotective sheath222 which covers theneedle204. Theprotective sheath222 is also capable of sliding alongdistal needle portion206 as well as theintermediate portion224 of theneedle204.
• The biasingmember202 is centrally located within thehousing208. InFIG. 20, the biasingmember202 is shown as a torsion spring. However, it is contemplated within the scope of the invention that other types of springs may be used such as a torsion arm. The biasingmember202 may define acenterline225 which may be aligned with a centerline of the internalarcuate groove216. Further, the biasing member'scenterline225 may be parallel with the distal needle portion206 (seeFIG. 20). The biasingmember202 may also have anextension226 which is configured to engage theprotective sheath222 in an equivalent fashion compared to theend portion176 of the third preferred embodiment or thecircular bend portion95 of the first preferred embodiment. The biasingmember202 may be translated between a retracted position and an extended position, as shown respectively inFIGS. 23 and 24. The spring force of the biasingmember202 may be greater at the retracted position compared to the spring force of the biasingmember202 at the extended position. In this regard, the biasingmember202 is biased to the extended position. Further, the retracted and extended positions of the biasingmember202 correspond to retracted and extended positions of theprotective sheath222, as shown inFIGS. 23 and 24 respectively.
• The biasingmember202 and theprotective sheath222 may remain in the retracted position with the aid of acatch228, as shown inFIG. 20. Thecatch228 and its operation is most clearly shown inFIGS. 23 and 24. In particular, thecatch228 defines a retained position (i.e., up position as shown inFIG. 23) and a release position (i.e., down position as shown inFIG. 24). Thecatch228 may be translated to the retain position after the biasingmember202 is translated to the retracted position. In this regard, the biasingmember202 may remain in the retracted position. Theprotective sheath222 which is engaged to theextension226 of the biasingmember202 may be translated to the extended position by translating thecatch228 to the release position. In this regard, theextension226 is allowed to pass over thecatch228 and unwind until theprotective sheath222 covers theneedle tip230.
• The spring force of the biasingmember202 may be adjusted higher or lower as desired. In particular, the biasingmember202 may engage an indexer232 (seeFIG. 20) which may be rotated counter clockwise to increase the spring force of the biasingmember202 and clockwise to decrease the spring force of the biasingmember202. As shown inFIG. 26, theindexer232 may engage the biasingmember202 and thelower half212 of thehousing208. In particular, the biasingmember202 may define an end portion234 which slides into aslot236 of theindexer232 at its lower surface238. And, theindexer232 may have a cylindrical configuration with a plurality of apertures240 (seeFIGS. 20 and 23) about its circumference. Theseapertures240 may engage a pin242 (seeFIG. 26) that protrudes from thelower half212 of thehousing208. Accordingly, theindexer232 may be rotated counter clockwise and then thepin232 may be inserted into the correspondingaperture240 to increase the spring force of the biasingmember202. And, conversely, theindexer232 may be rotated clockwise and then thepin232 may be inserted into the correspondingaperture240 to decrease the spring force of the biasingmember202. The counter clockwise and clockwise direction is defined with respect toFIG. 25.
• The mechanism by which thecatch228 may be translated from the retain position to the release position is embodied in a trigger mechanism. In particular, the trigger mechanism comprises atrigger244 is located on the exterior surface218 of thehousing208 extends through thehousing208 and engages thecatch232. Further, thetrigger244 is translateable between first and second positions. The first position of the trigger is shown inFIG. 23, and the second position of the trigger is shown inFIG. 24. In the first position, theextension226 of the biasingmember202 is retained in thecatch232. And, as thetrigger244 is translated to the second position, thetrigger244 engages thecatch232 and translates thecatch232 from the retain position to the release position. At which time, the biasing member's rotational force slides theprotective sheath222 within the internalarcuate groove216 and covers theneedle tip230.
• The various aspects of the present invention described through the first through third preferred embodiments above may be incorporated into the fourth preferred embodiment. For example, as stated above, the engagement between the biasingmember extension226 and theprotective sheath222 may be through theend portion176 as described in the third embodiment or thecircular bend portion95 as described in the first embodiment. Further, theknob member92 of the first embodiment,trigger member134 of the second embodiment or the sheath releasing mechanism of the third embodiment may be alternatively incorporated into the fourth preferred embodiment. Conversely, the various aspects of the fourth embodiment of the present invention may be incorporated into the other embodiments discussed above.
• Additional modifications and improvements of the present invention may also be apparent to those of ordinary skill in the art. Thus, the particular combination of parts described and illustrated herein is intended to represent only certain embodiments of the present invention, and is not intended to serve as limitations of alternative devices within the spirit and scope of the invention.

Claims (13)

1. A safety needle device for protecting a user against a needle-stick injury, the needle device comprising:

a needle housing having a distal housing opening;

a needle disposed within the needle housing and having a distal needle portion extending away therefrom through the distal housing opening;

an elongate sheath assembly surrounding the needle within the needle housing;

a biasing member engaged to the sheath assembly and being configured to apply a force thereupon towards the distal housing opening as the biasing member moves from a retracted position to an extended position, the biasing member defining a centerline which is parallel to the distal needle portion.

2. The needle device ofclaim 1 further comprising an indexer engageable with the biasing member and the housing to increase or decrease a spring force of the biasing member.

3. The needle device ofclaim 2 wherein the indexer has a cylindrical configuration with at least two apertures about its periphery, and the housing further has a pin fixed thereto which is sized and configured to be inserted into the aperture.

4. The needle device ofclaim 1 wherein the needle housing comprises a lower housing surface having a hold-down platform extending outwardly therefrom.

5. The needle device ofclaim 4 wherein the hold-down platform comprises a layer of padding to provide cushioning when the hold-down platform is applied upon the user.

6. The needle device ofclaim 5 wherein the layer of padding is attached underneath the hold-down platform.

7. The needle device ofclaim 5 wherein the layer of padding substantially conforms to a configuration of the hold-down platform.

8. The needle device ofclaim 5 wherein the layer of padding is fabricated from a foam material.

9. The needle device ofclaim 8 wherein the foam material is a closed-cell foam material.

10. The needle device ofclaim 1 wherein the needle housing comprises a groove elongated therewithin and communicating with the distal housing opening, the sheath assembly surrounding the needle within the groove.

11. The needle device ofclaim 1 wherein the biasing member is a torsional arm.

12. The needle device ofclaim 1 further comprising a catch to retain the biasing member in the retracted position.

13. The needle device ofclaim 12 wherein the catch defines a retain position and a release position, and the device further comprises a trigger engageable with the catch and operative to translate the catch from the retain position to the release position.

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