Activation of dual blunting needle assembly

A needle assembly that is adapted for blunting of both an intravenous puncture tip and a non-patient puncture tip is provided. The needle assembly includes a hub having an opening, an intravenous puncture tip, a non-patient puncture tip, a first blunting tip in concentric relation with the intravenous puncture tip, and a second blunting tip in concentric relation with the non-patient puncture tip. An actuator extends through the opening and is in engagement with either the first and second blunting tips or the intravenous puncture tip and the non-patient puncture tip. Activation of the actuator causes blunting of the intravenous puncture tip and the non-patient puncture tip by the first and second blunting tips. The needle assembly is particularly useful in connection with a blood collection system.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to needle assemblies having blunting elements for safe and convenient handling. More particularly, the present invention relates to a needle assembly having a double-ended needle for collecting or delivering fluid samples from or into a patient and which includes blunting elements for the double-ended needle.

2. Description of Related Art

Disposable medical devices having piercing elements are typically used for administering a medication or withdrawing a fluid, such as blood collecting needles, fluid handling needles and assemblies thereof. Current medical practice requires that the fluid containers and needle assemblies used in such systems be inexpensive and readily disposable. Consequently, existing blood collection systems, for example, typically employ some form of durable, reusable holder on which detachable and disposable needles and fluid collection tubes may be mounted. A blood collection system of this nature can be assembled prior to use and then disassembled after use. Thus, these blood collection systems allow repeated use of the relatively expensive holder by merely replacing the relatively inexpensive needle and/or fluid collection tube. In addition to reducing the cost of collecting blood specimens, these blood collection systems also help minimize the production of hazardous medical waste.

A popular design configuration of previously available blood collection systems includes a double-ended needle assembly, an evacuated collection tube, and a holder for maintaining the needle assembly and the collection tube in fixed relation. The double-ended needle assembly, which is also referred to as a cannula, has a bore extending therethrough and a hub near a central region thereof. The evacuated fluid collection tube includes a puncturable stopper at one end thereof. In this type of blood collection system, the holder typically has a housing at one end thereof for receiving the needle assembly. Likewise, the holder also has a hollow body with an opening at an opposite end thereof for receiving the collection tube. The needle assembly is rigidly received within the housing of the holder such that a first end of the needle extends forwardly of the holder for puncturing the vein of a patient. The opposite, second end of the needle extends into the hollow body of the holder. Upon assembly of the blood collection system, the needle assembly is inserted into the housing and the collection tube is inserted through the open end of the hollow body until the second end of the needle pierces the puncturable stopper of the collection tube, thereby allowing fluid communication between the interior of the collection tube and the bore which extends through the needle assembly. To draw a blood specimen from a patient using one of these blood collection systems, the evacuated collection tube is partially inserted into one end of the holder, the first end of the needle is inserted into a patient's vein and the collection tube is fully inserted into the holder such that blood will be drawn through the bore of the needle assembly and into the fluid collection tube. After drawing the specimen, the collection tube is removed so that the blood contained therein can be analyzed and the needle assembly is detached for disposal.

In addition to being capable of accommodating blood collection tubes, the holders of some fluid transfer systems are compatible with fluid containers having a fluid to be injected into a patient. Thus, such holders can be used to inject fluid into, as well as draw blood specimens from a patient.

In order to reduce the risk of incurring an accidental needle-stick wound, protection of the used needle tip becomes important. With concern about infection and transmission of diseases, methods and devices to enclose the used disposable needle have become very important and in great demand. Many arrangements have been designed for protecting used needle tips. For example, U.S. Pat. No. 5,951,520 to Burzynski et al., discloses a self-blunting needle in which a rod or probe-like blunting member is disposed within the bore of a needle cannula having a puncture tip suitable for puncturing tissue. To prevent accidental needle-stick wounds from occurring after use of the device, the blunting member, which is retracted behind the puncture tip when the needle is injected into tissue, can be extended beyond the puncture tip of the needle cannula to effectively blunt the puncture tip and eliminate or at least greatly reduce the risk of accidental needle-stick punctures. Such a device, however, does not provide protection for the second end of the needle at the non-patient end of the assembly.

U.S. Pat. No. 5,810,775 to Shaw discloses a collection assembly which provides for retraction of the intravenous needle at the patient end of the assembly, and further discloses a hinged cap at the open end of the housing of the holder. After drawing a specimen into a collection tube, the collection tube is removed, and the hinged cap is closed over the opening of the holder, thereby activating the needle retraction and blocking access to the second end of the needle at the non-patient end. Activation of the hinged cap and the retraction mechanism requires substantial manipulation by the user and cannot be conveniently accomplished with a single hand, as is ideal for typical phlebotomy practice. Furthermore, the size of the device is relatively large, and the retraction mechanism for the needle can cause splattering of blood when the tip of a used needle is accelerated during retraction, thus potentially exposing health care workers to blood-borne pathogens.

Accordingly, a need exists for a needle assembly which provides for safety blunting of the needle at both the intravenous and the non-patient needle points while minimizing aerosolization of blood particulates that may carry infectious diseases, and which is simple to manufacture, easy to operate and does not occupy a significant amount of disposal space.

SUMMARY OF THE INVENTION

The present invention is directed to a dual blunting needle assembly which is adapted for blunting of both an intravenous puncture tip and a non-patient puncture tip, such as for use in connection with a blood collection system.

The needle assembly of the present invention includes a cannula having a first end with an intravenous puncture tip and a second end with a non-patient puncture tip. Desirably, the first and second ends of the cannula are separate members. The assembly further includes a blunting member in concentric relation with the cannula, which includes a first blunt end proximate the intravenous puncture tip of the cannula and a second blunt end proximate the non-patient puncture tip of the cannula. An actuator is in engagement with the blunting member and the cannula. Activation of the actuator causes blunting of both the intravenous puncture tip and the non-patient puncture tip by the blunting member. In particular, the actuator causes relative axial displacement of the cannula and the blunting member with respect to each other between a non-blunted position and a blunted position in which the intravenous tip and the non-patient tip are blunted by the blunting member, such as by axial movement of either the cannula or the blunting member. Such blunting of the intravenous tip and the non-patient tip may occur simultaneously, or may occur consecutively in succession through a single activation of the actuator.

The blunting member is preferably disposed within an internal lumen of the cannula. Alternatively, the blunting member may be disposed about the cannula. The blunting member is in fixed engagement with the actuator, and the first and second ends of the cannula are axially movable with respect to the blunting member upon actuation of the actuator.

Alternatively, the first and second ends of the blunting member may be separate members, and the cannula may be in fixed engagement with the actuator. As such, the first and second ends of the blunting member are axially movable with respect to the cannula upon actuation of the actuator.

The present invention is also directed to a safety assembly which includes a needle holder and a needle assembly in engagement with the needle holder. The needle assembly preferably includes a cannula having a first end with an intravenous puncture tip and a second end with a non-patient puncture tip; a blunting member in concentric relation with the cannula which includes a first blunt end proximate the intravenous puncture tip of the cannula and a second blunt end proximate the non-patient puncture tip of the cannula; and an actuator in engagement with the blunting member and the cannula. Activation of the actuator causes blunting of both the intravenous puncture tip and the non-patient puncture tip by the blunting member.

Desirably, the first and second ends of the cannula are separate members, with the first end representing an intravenous cannula including the intravenous puncture tip, and the second end representing a non-patient cannula including the non-patient tip.

The needle assembly may be attached to the needle holder through the actuator. The actuator may include a first displacement mechanism for displacement of the intravenous cannula and a second displacement mechanism for displacement of the non-patient cannula. The first and second displacement mechanisms are preferably leads which are threaded in opposing relation with respect to each other.

A front hub assembly may also be provided for establishing engagement between the intravenous cannula and the actuator. Such a front hub assembly may include internal threads for engagement with the threaded leads of the first displacement mechanism. Moreover, an insert may also be provided for securement of the intravenous cannula to the front hub assembly.

A rear hub assembly may also be provided for establishing engagement between the non-patient cannula and the actuator. The rear hub assembly may include internal threads for engagement with the threaded leads of the second displacement mechanism. Also, the needle assembly may be attached to the needle holder through the rear hub assembly. For example, the rear hub assembly may include external threads for cooperating engagement with internal threads on the needle holder.

The actuator is rotatable about an axis defining the safety assembly, with rotation of the actuator causing the intravenous cannula and the non-patient cannula to axially displace with respect to the blunting element. The actuator may be reversibly rotatable about an axis defining the safety assembly, or may be rotatable about an axis defining the safety assembly in a single direction, thereby causing the intravenous cannula and the non-patient cannula to axially displace relative to the blunting member from the first retracted or non-blunted position to the second extended or blunted position. Also, the actuator may include a locking mechanism for preventing axial displacement of the intravenous cannula and the non-patient cannula from the second extended position to the first retracted position.

Rotation of the actuator may also cause the intravenous cannula to axially displace relative to the blunting member at a different distance than the non-patient cannula. Initial rotation of the actuator may cause the intravenous cannula to axially displace between the first retracted or non-blunted position and the second extended or blunted position, and further rotation may cause the non-patient cannula to axially displace between the first retracted or non-blunted position, and the second extended or blunted position.

The present invention is further directed to a dual blunting safety assembly which includes a needle assembly and a needle holder attached to the needle assembly. The needle assembly includes an intravenous cannula having a puncture tip and a through-hole for fluid flow therethrough, a non-patient cannula having a puncture tip and a through-hole for fluid flow therethrough, a blunting member extending between the intravenous cannula and the non-patient cannula and concentrically disposed within the through-hole of the intravenous cannula and the through-hole of the non-patient cannula. The needle assembly also includes a first blunting end for blunting the puncture tip of the intravenous cannula, a second blunting end for blunting the puncture tip of the non-patient cannula, and an actuator in fixed engagement with the blunting member and including a displacement mechanism for axial displacement of the intravenous cannula and the non-patient cannula with respect to the blunting member. Actuation of the actuator causes the intravenous cannula and the non-patient cannula to axially displace relative to the blunting member between a first retracted or non-blunted position in which the puncture tip of the intravenous cannula extends beyond the first blunting end and the puncture tip of the non-patient cannula extends beyond the second blunting end, and a second extended or blunted position in which the first blunting end extends beyond the puncture tip of the intravenous cannula and the second blunting end extends beyond the puncture tip of the non-patient cannula, thereby blunting both the puncture tip of the intravenous cannula and the puncture tip of the non-patient cannula.

The present invention is further directed to a dual blunting needle assembly including a hub, which is adapted for attachment to a separate needle holder. The hub includes an internal lumen extending between opposing first and second ends. An intravenous puncture tip extends from the first end and a non-patient puncture tip extends from the second end of the hub. A first blunting tip is in concentric relation with and proximate to the intravenous puncture tip. A second blunting tip is in concentric relation with and proximate to the non-patient puncture tip. An opening, preferably a circumferential opening, extends through the hub into the internal lumen, with a flexible actuator extending through the opening. The flexible actuator is in engagement with either the intravenous puncture tip and the non-patient puncture tip or with the first blunting tip and the second blunting tip.

Flexing or bending movement of the actuator within the opening causes relative axial displacement between opposing ends of the actuator and, therefore, between the intravenous puncture tip and the first blunting tip, such that the intravenous puncture tip is blunted by the first blunting tip, and between the non-patient puncture tip and the second blunting tip such that the non-patient puncture tip is blunted by the second blunting tip. The intravenous puncture tip and the non-patient puncture tip may be blunted simultaneously or consecutively.

To effectuate the flexing or bending movement of the actuator, the actuator may be rotatable within the opening about an axis defining the needle assembly. The actuator includes a bent portion extending through the opening, which can act as a handle for enabling rotation of the actuator.

The opening desirably includes a circumferential track defining a first track portion and a second track portion. In one embodiment, a first surface and an opposing second surface extend through the first track portion and the second track portion, with the first surface being axially spaced from the second surface at a greater distance at the second track portion than at first track portion.

In a preferred embodiment, the first blunting tip and the second blunting tip are provided as separate members. The first blunting tip extends from a first blunting member that is in concentric relation about the cannula. The second blunting tip extends from a second blunting member that is also in concentric relation about the cannula. The actuator is attached to the first blunting member and to the second blunting member. Flexing of the actuator causes the first blunting member and the second blunting member to axially displace with respect to each other and with respect to the intravenous puncture tip and the non-patient puncture tip, respectively, causing blunting of the intravenous puncture tip and the non-patient puncture tip. A first portion of the actuator is adjacent the first blunting member and cooperates with the first surface for guidance through the circumferential track. A second portion of the actuator is adjacent the second blunting member and cooperates with the second surface for guidance through the circumferential track.

In another embodiment, the cannula includes a first cannula and a second cannula as separate members. The intravenous puncture tip extends from the first cannula that is in concentric relation about the blunting member. The non-patient puncture tip extends from the second cannula that is also in concentric relation about blunting member. The actuator is attached to the first cannula and to the second cannula. Bending of the actuator causes the first cannula and the second cannula to axially displace with respect to each other and with respect to the first blunting tip and the second blunting tip, respectively, causing blunting of the intravenous puncture tip and the non-patient puncture tip. The first portion of the actuator is adjacent the first cannula and cooperates with the first surface for guidance through the circumferential track. The second portion of the actuator is adjacent the second cannula and cooperates with the second surface for guidance through the circumferential track.

DETAILED DESCRIPTION

While the present invention is satisfied by embodiments in many different forms, there is shown in the drawings and will herein be described in detail, the preferred embodiments of the invention, with the understanding that the present disclosure is to be considered as exemplary of the principles of the invention and is not intended to limit the invention to the embodiments illustrated. Various other embodiments will be apparent to and readily made by those skilled in the art without departing from the scope and spirit of the invention. The scope of the invention will be measured by the appended claims and their equivalents.

Referring to the drawings in which like reference characters refer to like parts throughout the several views thereof,FIGS. 1-9illustrate a dual blunting safety assembly in accordance with the present invention and the related features. The safety assembly includes a needle assembly in the form of a double-ended needle for use, for example, in combination with a needle holder for collecting blood samples, as is known in the art. The present invention is generally described in terms of a needle assembly, and encompasses a needle assembly as well as a safety assembly which incorporates the needle assembly and the needle holder, with the needle assembly and the needle holder including interrelating elements to provide for engagement therebetween, as will be discussed in more detail herein.

Safety assembly10of the present invention is shown generally atFIGS. 1-5. Safety assembly10includes a needle assembly12, which is adapted for attachment to a separate needle holder16. In this manner, needle assembly12can be provided as a disposable unit for use with a re-usable holder.

Needle assembly12, generally speaking, includes a cannula having a first end with an intravenous puncture tip24, and a second end with a non-patient puncture tip28. A central bore or through-hole20extends through needle assembly12from intravenous puncture tip24to non-patient puncture tip28, for providing the passage of fluid therethrough, and to movably accommodate blunting member30, as will be discussed in more detail. Intravenous puncture tip24is provided for insertion into the vein of a patient, and non-patient puncture tip28is provided for puncturing of an evacuated tube, for example, during a blood collection procedure. Accordingly, intravenous puncture tip24is desirably shaped to provide for ease of insertion and minimal discomfort during venipuncture, such as with a tapered pointed end, as is shown in the FIGS. and is known in the art.

Desirably, the first end and second end of needle assembly12are provided as separate members. More particularly, needle assembly12is provided with a first intravenous cannula22having intravenous puncture tip24, and a second non-patient cannula26having non-patient puncture tip28. Second non-patient cannula26is further provided with an elastomeric sleeve18extending thereabout, and covering non-patient puncture tip28, as is generally known in the art.

Needle assembly12further includes blunting member30. Blunting member30includes a first blunting end32and a second blunting end36at opposing ends thereof, with a central bore or through-hole38extending therethrough from first blunting end32to second blunting end36, for fluid flow therethrough. First blunting end32and second blunting end36are blunted such that, under ordinary hand pressure, they will not easily puncture human skin or other biological tissue.

Blunting member30is provided in concentric relation with the cannula of needle assembly12. For example, blunting member30may extend between first intravenous cannula22and second non-patient cannula26of needle assembly12and be concentrically disposed within through-hole20of needle assembly12, as shown generally inFIGS. 1-7. Alternatively, blunting member30may be provided about needle assembly12such that first intravenous cannula22and second non-patient cannula26of needle assembly12are provided within through-hole38of blunting member30, as shown generally inFIGS. 10-11, and described in more detail herein.

As best depicted inFIGS. 4-5, first blunting end32of blunting member30is adjacent or proximate first intravenous cannula22of needle assembly12, and second blunting end36of blunting member30is adjacent or proximate second non-patient cannula26of needle assembly12. First intravenous cannula22is axially slidable about first blunting end32of blunting member30, and second non-patient cannula26is axially slidable about second blunting end36of blunting member30. The inner diameter of first intravenous cannula22is substantially the same as the outer diameter of first blunting end32of blunting member30, and the inner diameter of second non-patient cannula26is substantially the same as the outer diameter of second blunting end36of blunting member30. As such, needle assembly12and blunting member30are dimensioned and configured for a close fit, such that the external diameter of blunting member30is a close fit with the internal diameter of both first intravenous cannula22, and second non-patient cannula26of needle assembly12so that intravenous puncture tip24and non-patient puncture tip28lie flat on the surface of blunting member30when blunting member30is in an extended position, as shown inFIGS. 4-5.

Through-hole38of blunting member30allows fluid flow through needle assembly12during use. In alternative embodiments, however, an internal blunting member need not be hollow to accommodate fluid flow therethrough, but in such case the blunting member may have a diameter sufficiently smaller than the internal diameter of the needle cannula to allow adequate fluid flow in the annular space between them.

Further, it may be desirable to lubricate the mating surfaces of blunting member30and first intravenous cannula22and second non-patient cannula26, as well as to provide a seal between them to prevent the unwanted flow of air bubbles. Accordingly, a drop of viscous sealant-lubricant, such as silicone oil or petroleum jelly, may be provided about the mating surfaces thereof.

Needle assembly12further includes an actuator40. Actuator40is rotatable about an axis100which defines safety assembly10. Actuator40includes handle48and an internal bore or through-hole44extending therethrough. Further, actuator40is in engagement with blunting member30, as well as first intravenous cannula22and second non-patient cannula26.

More particularly, blunting member30is in fixed engagement with actuator40. For example, blunting member30may be integral with actuator40, or blunting member30may be a separate member which is fixedly adhered to and extends within through-hole44of actuator40, with first blunting end32and second blunting end36extending from opposing axial ends of actuator40. Alternatively, blunting member30may be provided as two separate and discrete members, both of which are fixedly adhered to opposing axial ends of actuator40. In such an embodiment, each of the sections of blunting member30has a through-hole38, both of which are in fluid alignment with through-hole44of actuator40, for providing continuous fluid communication therethrough. Blunting member30may be fixedly attached to actuator40, for example, using a medical grade adhesive. Since blunting member30and actuator40are fixedly attached, rotation of actuator40also causes rotation of blunting member30within through-hole20of needle assembly12.

Actuator40is also in engagement with needle assembly12through first intravenous cannula22and second non-patient cannula26. In particular, actuator40includes structure for engagement with each of first intravenous cannula22and second non-patient cannula26. Such engagement structure is adapted to provide for relative axial displacement of first intravenous cannula22and second non-patient cannula26with respect to each other, such as through a displacement mechanism. For example, actuator40may be provided with dual leads for displacing first intravenous cannula22and second non-patient cannula26. Such dual leads are desirably provided as two sets of threads on opposing ends of actuator40, such as first threads42in engagement with first intravenous cannula22forming a first displacement mechanism and second threads46in engagement with second non-patient cannula26forming a second displacement mechanism. While the engagement structure is discussed herein in terms of dual leads in the form of interengaging threaded surfaces, it is contemplated that such engagement structure may comprise other forms, so long as the engagement structure provides for relative axial displacement of the components as discussed. For example, it is contemplated that relative axial displacement may be achieved through any structure capable of providing actuation for relative axial displacement, such as dual camming surfaces, gears, a dual actuated piston-type structure, and the like.

First threads42and second threads46are threaded in opposing relation with respect to each other, and are desirably external threads extending about the external ends of actuator40, respectively. As such, rotation of actuator40about an axis100, such as by rotating actuator40in a direction of arrow110, causes rotation of first threads42and second threads46. Since first threads42and second threads46are threaded in opposing relation with respect to each other, actuation of actuator40about axis100in a direction of arrow110causes first threads42and second threads46to rotate in opposing threaded relation with respect to each other. Further, since first threads42are in engagement with first intravenous cannula22, and second threads46are in engagement with second non-patient cannula26, rotation in opposing threaded relation thereof causes displacement of first intravenous cannula22and second non-patient cannula26in opposing axial directions relative to actuator40. Since blunting member30is in fixed engagement with actuator40, such actuation of actuator40causes intravenous cannula22and non-patient cannula26to axially displace relative to blunting member30between a first retracted position in which intravenous puncture tip24extends beyond first blunting end32and non-patient puncture tip28extends second blunting end36, as depicted inFIGS. 4-5, and a second extended position in which first blunting end32extends beyond intravenous puncture tip24and second blunting end36extends beyond non-patient puncture tip28, as depicted inFIGS. 6-9, thereby simultaneously blunting intravenous puncture tip24and non-patient puncture tip28of needle assembly12.

As noted, first threads42are in engagement with first intravenous cannula22. Such engagement is achieved, for example, through front hub assembly50. Front hub assembly50includes a central opening52extending therethrough. A first end of front hub assembly50is provided for engagement with first threads42of actuator40. For example, internal threads54may be provided within the end of central opening52, which internal threads54are capable of threaded engagement with external first threads42of actuator40. A second end of front hub assembly50is provided for attachment to first intravenous cannula22. Such attachment may be accomplished through hub insert56, which attaches directly to first intravenous cannula22and fits within the second end of front hub assembly50. Front hub assembly50is further provided with a hub arm58, which extends from front hub assembly50. As will be discussed in more detail, hub arm58provides for engagement between first intravenous cannula22and second non-patient cannula26for axial displacement therebetween.

Front hub assembly50may further be provided with means or structure for attachment of a needle cover (not shown), such as shoulder60at the second end thereof. Shoulder60is provided for engagement with a needle cover, which covers intravenous puncture tip24of first intravenous cannula22prior to assembling of needle assembly12with holder16. Such a needle cover may be constructed of rigid polymeric material, as is known in the art. Shoulder60preferably includes a profile to provide for a frictional engagement with the needle cover, such that the needle cover is maintained in position about shoulder60in a friction fit, thereby covering and protecting first intravenous cannula22until assembly and use.

Second threads46of actuator40are in engagement with second non-patient cannula26. Such engagement may be achieved, for example, directly through holder16. For example, as depicted inFIGS. 4-9, holder16is defined generally by hollow body70, which includes first end72, and second end76. First end72of holder16includes an opening74extending therethrough, while second end76is generally open-ended, providing holder16with a hollow body70having an internal opening78extending therethrough. Such internal opening78accommodates a blood sampling tube (not shown) during a sampling procedure, as is known in the art.

Non-patient cannula26is fixedly attached directly to holder16within internal opening78at first end72adjacent opening74. Such attachment may be accomplished, for example, through the use of a medical grade adhesive. Actuator40is directly in engagement with holder16at opening74. Such engagement may be provided through internal threads86within opening74, which internal threads86are capable of threaded engagement with external second threads46of actuator40. Such engagement may alternatively be provided through a snap-fit engagement or the like.

Holder16engages with front hub assembly50, for establishing axial displacement between first intravenous cannula22and second non-patient cannula26. For example, extension80may extend externally from first end72of body70in an axial direction with respect to safety assembly10. Extension80may include channel82, for slidable engagement with hub arm58of front hub assembly50. During rotation of actuator40about axis100, first threads42and second threads46are rotated in opposing threaded relation with respect to each other, thereby causing displacement of front hub assembly50and holder16in opposing axial directions, such as toward each other, as will be discussed in more detail herein. Thus, in such an embodiment, safety assembly10of the present invention encompasses a single unit, which incorporates the holder and the needle into a single assembly, with the holder and the needle including interrelating elements to provide for engagement therebetween.

Actuator40may be reversibly rotatable about axis100of safety assembly12, thereby providing for reversibly switching between a first non-blunted position for sampling and a second blunted position for safety shielding. More desirably, actuator40is rotatable about axis100of safety assembly10in a single direction, such as in the direction of arrow110. As such, intravenous cannula22and non-patient cannula26are axially displaceable relative to each other in only a single direction and, therefore, are axially displaceable relative to blunting member30from a first retracted or non-blunted position in which first blunting end32is positioned short of intravenous puncture tip24and second blunting end36is positioned short of non-patient puncture tip28, and a second extended or blunted position in which first blunting end32extends beyond intravenous puncture tip24and second blunting end36extends beyond non-patient puncture tip28.

Rotation of actuator40may cause simultaneous axial displacement of first intravenous cannula22and second non-patient cannula26with respect to each other, thereby causing simultaneous blunting of both first intravenous cannula22and second non-patient cannula26. Alternatively, rotation of actuator40may cause axial displacement of first intravenous cannula22and second non-patient cannula26with respect to each other in a consecutive manner. As such, actuation of actuator40causes successive blunting of one of the cannulae prior to blunting of the other cannulae through a single actuation of actuator40. For example, rotation of actuator40may cause axial displacement of first intravenous cannula22and second non-patient cannula26with respect to each other at a different distance with respect to blunting member30. More particularly, it may be desirable to blunt first intravenous cannula22and second non-patient cannula26at different times, for example, by first blunting first intravenous cannula26after a blood sample has been collected but prior to removing first intravenous cannula22from the patient, and then blunting second non-patient cannula26after removing first intravenous cannula22from the patient. This may be achieved by providing blunting of first intravenous cannula22and second non-patient cannula26at different points of rotation of actuator40. For example, during initial rotation of actuator40about axis100, first intravenous cannula22may axially displace with respect to blunting member30to cause first blunting end32to be exposed and extend beyond intravenous puncture tip24. Further rotation of actuator40about axis100may then cause second non-patient cannula26to axially displace with respect to blunting member30to cause blunting end36to be exposed and extend beyond non-patient puncture tip28.

Such varying displacement of first intravenous cannula22and second non-patient cannula26, with respect to blunting member30, may be achieved, for example, by providing the threading of first threads42and second threads46of actuator40with varying pitches of threading in opposing relation. More particularly, first threads42may be provided at a first thread pitch and second threads46may be provided at a second thread pitch such that first intravenous cannula22axially displaces with respect to blunting member30in a direction toward actuator40and toward second non-patient cannula26at a faster rate than second non-patient cannula26axially displaces with respect to blunting member30in a direction toward actuator40and toward first intravenous cannula22. As such, needle assembly12is provided in a first retracted position in which intravenous puncture tip24extends beyond first blunting end32of blunting member30and non-patient puncture tip28extends beyond second blunting end36of blunting member30. Initial rotation of actuator40about axis100to an intermediate position will cause first intravenous cannula22to axially displace from the first retracted position to a second extended position in which first blunting end32of blunting member30extends beyond intravenous puncture tip24. Further rotation of actuator40about axis100to a final position will cause second non-patient cannula26to axially displace from the first non-blunted position to a second blunted position in which second blunting end36of blunting member30extends beyond non-patient puncture tip28. As such, both intravenous puncture tip24and non-patient puncture tip28are blunted, albeit not simultaneously, but consecutively one after the other with a single rotation of the actuator.

Such varying displacement of first intravenous cannula22and second non-patient cannula26with respect to blunting member30may also be achieved through other mechanisms, such as by providing first intravenous cannula22and second non-patient cannula26at different starting positions in the first non-blunted state, in addition to or instead of varying the pitch threading of first threads42and second threads46. For example, blunting end32may be positioned closer to intravenous puncture tip24than blunting end36is positioned with respect to non-patient puncture tip28. In this manner, rotation of actuator40about axis100will cause axial displacement of first intravenous cannula22and second non-patient cannula26in opposing directions with respect to each other and with respect to blunting member30, which will cause first blunting end32of blunting member30to extend beyond intravenous puncture tip24before second blunting end36of blunting member30extends beyond non-patient puncture tip28.

Actuator40may include a locking mechanism for preventing axial rotation in the reverse direction and, therefore, preventing axial displacement of intravenous cannula22and non-patient cannula26from the blunted position to the non-blunted position. For example, this may be achieved by providing first threads42and second threads46as a ratcheted threaded engagement with internal threads54and opening74, respectively. Such a ratcheted threaded engagement permits threading in only one direction, thereby preventing the threads from rotating in the opposite direction.

Actuator40may also include a mechanism for preventing rotation of actuator40beyond a predetermined point. Extension80may work in this manner, preventing handle48from rotating about axis100of safety assembly10beyond a certain point. A locking mechanism for preventing axial rotation of actuator40in the opposite direction may be provided on extension80, which engages handle48to prevent such rotation. Also, actuator40may be provided with means for detecting activation or rotation thereof about axis100, such as audible, visible and/or tactile indication to identify that actuator40has been rotated to effect blunting of the needle assembly12.

Operation and use of the safety assembly10of the present invention will now be described. In use, needle assembly12is provided attached to holder16, including a needle cover (not shown) extending over intravenous cannula22.

The needle cover extending over intravenous cannula22is removed. Venipuncture is then conducted in known manner, whereby intravenous puncture tip24is inserted into a vein of a patient, and an evacuated tube having a piercable closure is inserted into opening78of holder16, such that the piercable closure of the evacuated tube contacts sleeve18extending about non-patient cannula26. When pressure is exerted on the evacuated tube, the piercable closure contacting sleeve18causes sleeve18to displace, thereby causing non-patient puncture tip28to puncture sleeve18and, in turn, the piercable closure of the evacuated tube. At such time, the interior of the evacuated tube and through-hole20of needle assembly12are in fluid communication. Since the interior of the evacuated tube is at a negative pressure, blood is drawn from the vein of the patient, through through-hole20of needle assembly12and into the evacuated tube.

When all desired samples have been drawn, activation of the dual blunting needle assembly is accomplished. Activation of the dual blunting needle assembly is desirably accomplished while venipuncture is maintained, that is while intravenous cannula22is maintained within the vein of the patient, in order to prevent an accidental needle stick prior to blunting of the needle. Blunting of the needle assembly12is accomplished by rotating handle48of actuator40about the axis100of safety assembly10. During rotation of actuator40about axis100, first threads42and second threads46of actuator40, which are threaded in opposing direction, are rotated in opposing threaded relation with respect to each other. With first threads42of actuator40in engagement with internal threads54of front hub assembly50, and second threads46of actuator40in engagement with opening74of holder16, opposing rotation of first threads42and second threads46with respect to each other causes displacement of front hub assembly50in a direction of arrow120and holder16in a direction of arrow130, that is in opposing axial directions toward each other. Moreover, with extension80fixedly attached to holder16, and hub arm58of front hub assembly50positioned within channel82of extension80, axial rotation of front hub assembly50and holder16with respect to each other is prevented. As such, hub arm58can only move in slidable engagement with respect to channel82of extension80in an axial direction.

Since first intravenous cannula22is attached to front hub assembly50and since second non-patient cannula26is attached to holder16, axial displacement of front hub assembly50and holder16in opposing axial directions also causes axial displacement of first intravenous cannula22in a direction of arrow120and second non-patient cannula26in a direction of arrow130, that is in opposing axial directions toward each other. Moreover, since blunting member30is fixedly attached to actuator40, blunting member30remains axially in place during rotation of actuator40, and rotates within needle assembly12. Since first blunting end32and second blunting end36of blunting member30are positioned within through-hole20proximate first intravenous cannula22and second non-patient cannula26, respectively, movement of first intravenous cannula22and second non-patient cannula26in a direction toward each other exposes first blunting end32and second blunting end36beyond intravenous puncture tip24and non-patient puncture tip28, respectively. As such, intravenous puncture tip24and non-patient puncture tip28are effectively blunted due to the blunt ends of blunting member30extending therebeyond. Safety assembly10can then be removed from the patient's vein, and appropriately discarded.

FIGS. 10-20depict further embodiments of the present invention, and include many components which are substantially identical to the components ofFIGS. 1-9. Accordingly, similar components performing similar functions will be numbered identically to those components ofFIGS. 1-9, except that a suffix “a” will be used to identify those similar components inFIGS. 10-11, a suffix “b” will be used to identify those similar components inFIGS. 12-19, and a suffix “c” will be used to identify those similar components inFIG. 20.

As noted above, in an alternate embodiment as shown inFIGS. 10 and 11, blunting member30amay be provided about needle assembly12a. In such an embodiment, the cannula of needle assembly12ais provided as a single member having a first intravenous end22awith an intravenous puncture tip24a, and a second non-patient end26awith a non-patient puncture tip28a. Further, blunting member30aincludes first blunting end32aand second blunting end36aas discrete and separate members. First blunting end32ais axially slidable about the first intravenous end22a, and second blunting end36ais axially slidable about the second non-patient end26a.

The cannula of needle assembly12ais in fixed engagement with actuator40a, while first blunting end32ais attached to a first end of actuator40aand second blunting end36ais attached to a second end of actuator40ain a similar manner as the attachment of the blunting member and the first intravenous cannula22and second non-patient cannula26discussed in the embodiment described above. For example, actuator40amay be provided with dual leads threaded in opposing direction for displacing first blunting end32aand second blunting end36awith respect to each other, although such leads are desirably threaded in an opposite manner as in the embodiment described above. As such, rotation of actuator40aabout axis100ain a direction of arrow112acauses axial displacement of first blunting end32ain a direction of arrow122aand second blunting end36ain a direction of arrow132a, and with respect to first intravenous cannula22aand second non-patient cannula26a, respectively. Thus, first blunting end32aand second blunting end36aare axially displaced to extend beyond and encompass or surround intravenous puncture tip24aand non-patient puncture tip28a, respectively, thereby effectively simultaneously blunting the needle assembly.

In a further embodiment of the present invention, a standard holder for blood collection may be used with the needle assembly to provide a safety assembly. For example, as depicted inFIGS. 12-19, needle assembly12bmay be attached to a standard needle holder16bfor use in blood collection procedures. In such an embodiment, needle assembly12bdoes not attach to needle holder16bthrough second threads46bas in the embodiment described above with respect toFIGS. 1-9. Instead, in the embodiment ofFIGS. 12-19, needle assembly12bis provided with rear hub assembly90b, which provides for attaching of needle assembly12bto a standard needle holder16b, and which incorporates means for engagement with actuator40b, such as internal threads94bwithin rear hub assembly90bfor threaded engagement with second threads46bof actuator40b.

More particularly, as shown in the exploded view ofFIG. 14, holder16bincludes a generally tubular body70bhaving first end72band second end76b. As with holder16of the embodiment described above, first end72bincludes opening74bextending therethrough, while second end76bis generally open ended, providing holder16bwith a hollow body70bhaving internal opening78bextending therethrough for accommodating a blood sampling tube.

In the embodiment depicted inFIGS. 1-9, second non-patient cannula26is fixedly attached directly to holder16within internal opening78at first end72adjacent opening74, and actuator40is directly in engagement with holder16at opening74, such as through threaded engagement between internal threads86and second threads46. In the alternate embodiment ofFIGS. 12-19, needle assembly12bis provided with rear hub assembly90b, which establishes direct engagement between second non-patient cannula26band actuator40b. As such, needle assembly12bis provided as a complete double-ended needle assembly capable of use with a standard needle holder.

As shown in detail inFIGS. 12-19, alternate needle assembly12bincludes rear hub assembly90b. Rear hub assembly90bincludes a central opening92bextending therethrough, and includes internal threads94bat one end thereof and external threads96bat the other end thereof. Internal threads94bare provided for threaded engagement with second threads46bof actuator40b, while external threads96bare provided for threaded engagement with internal threads86bwithin opening74bat first end72bof holder16b. Second non-patient cannula26bis attached to rear hub assembly90b, with sleeve18bextending thereabout. Since second non-patient cannula26bis directly attached to needle assembly12b, needle assembly12bcan be provided as a separate assembly which can be attached to a standard needle holder such as holder16bjust prior to use. As such, needle assembly12bmay further be provided with a needle cover (not shown) for covering second non-patient cannula26bduring packaging and handling, which needle cover can be removed prior to assembly with holder16b.

As noted, needle assembly12bis attached to holder16bthrough rear hub assembly90b, particularly through external threads96b. It is noted that such attachment may be accomplished through any attachment mechanism, such as a snap fit or interference engagement, and is desirably accomplished through a threaded engagement such as through external threads96bin cooperating engagement with internal threads86b.

Rear hub assembly90bengages with front hub assembly50b, for establishing axial displacement between first intravenous cannula22band second non-patient cannula26b. For example, extension80bmay extend externally from rear hub assembly90bin an axial direction with respect to safety assembly10b, in a similar manner as extension80extends from holder16in the embodiment depicted inFIGS. 1-9. Extension80bmay include channel82b, for slidable engagement with hub arm58bof front hub assembly50b.

As noted, internal threads94bof rear hub assembly90bare provided for threaded engagement with second threads46bof actuator40b. As such, actuation of actuator40bby rotation about axis100b, which causes opposing rotation of first threads42band second threads46bwith respect to each other as described above, also causes displacement of front hub assembly50band rear hub assembly90bin opposing axial directions toward each other. Since first intravenous cannula22bis attached to front hub assembly50b, and since second non-patient cannula26bis attached to rear hub assembly90b, axial displacement of front hub assembly50band rear hub assembly90bin opposing axial directions also causes axial displacement of first intravenous cannula22band second non-patient cannula26bin opposing axial directions toward each other. This axial movement results in blunting of the intravenous puncture tip24band non-patient puncture tip28bby the blunt ends of blunting member30b, in a similar manner as described in connection with the embodiment ofFIGS. 1-9.

It is noted that first intravenous cannula22band second non-patient cannula26bmay be axially displaceable with respect to each other at a different distance with respect to blunting member30b, as discussed in the previously described embodiment. For example, this may be accomplished by providing first threads42band second threads46bwith different thread pitches or by positioning first intravenous cannula22band second non-patient cannula26bat differing starting points, as noted above.

As discussed above, actuator40bmay include a locking mechanism for preventing axial rotation and, therefore, preventing axial displacement of intravenous cannula22band non-patient cannula26bfrom the extended position to the retracted position, and may be provided with means for detecting activation or rotation thereof about axis10b, such as audible, visible and/or tactile indication to identify that actuator40bhas been rotated to effect blunting of the needle assembly.

FIG. 20depicts an exploded view of a rear hub assembly90cin an alternate embodiment, including extension80cand channel82c. In order to provide such a locking mechanism and/or such audible, visible and/or tactile indication, extension80cmay be provided with fingers88cprojecting within channel82c. In particular, as described above, rotation of actuator40about axis100causes axial displacement of first intravenous cannula22and second non-patient cannula26, through axial movement of front hub assembly50and rear hub assembly90toward each other. This causes hub arm58to slide within channel82. In embodiments incorporating fingers88cwithin channel82cas shown inFIG. 20, an audible and/or tactile indication is provided to the operator that the blunting mechanism has been activated when hub arm58slides beyond fingers88cwithin channel82c. Moreover, the shape and design of fingers88cmay prevent axial displacement of hub arm58within channel82cin the opposite direction, thereby preventing reversible rotation of actuator40, and effectively locking the needle assembly in the extended or activated blunting position.

Moreover, additional fingers may be provided within channel82cat a further axial position therein, which are particularly useful in embodiments where first intravenous cannula22and second non-patient cannula26are axially displaceable with respect to each other at a different distance with respect to blunting member30, as discussed above. By including such additional fingers, an indication and/or locking position may be initially provided when intravenous puncture tip24has been blunted by first blunting end32, and a further indication and/or locking position may then be provided when non-patient puncture tip28has been blunted by second blunting end36. It is noted that such fingers88cmay also be provided on extension80within channel82in the initial embodiment as described above with respect toFIGS. 1-9.

The safety assembly of the present invention including the needle assembly and the holder may be comprised of moldable parts which can be mass produced from a variety of materials including, for example, polyethylene, polyvinyl chloride, polystyrene or the like. Materials will be selected which will provide the proper support for the structure of the invention in its use, and which also provide a degree of resiliency for the purpose or providing the cooperative relative movement.

FIGS. 21-31depict yet a further embodiment of a dual blunting needle assembly200of the present invention. Needle assembly200includes a hub202, which is adapted for attachment to a separate needle holder204. In this manner, needle assembly200can be provided as a disposable unit for use with a re-usable holder204.

Hub202includes a longitudinal wall206having an internal lumen208extending between opposing first and second ends210,212of hub202. An opening222, extends through hub202into internal lumen208. Opening222is desirably a circumferential opening which extends through longitudinal wall206of hub202at least partially about a circumference thereof, and includes a circumferential track230including a first track portion232extending between opposing edges233and a second track portion234extending between opposing edges235. Opposing edges235of second track portion234are spaced from each other at a greater distance than opposing edges233of first track portion232, thereby providing second track portion234with a larger axial opening than first track portion232. A first surface236and an opposing second surface238extend between opposing edges233of first track portion232and opposing edges235of second track portion234, such that first surface236is axially spaced from second surface238at a greater distance at second track portion234than at first track portion232.

An intravenous puncture tip214extends from first end210of hub202, and a non-patient puncture tip216extends from second end212of hub202. Intravenous puncture tip214is provided for insertion into the vein of a patient, and non-patient puncture tip216is provided for puncturing of an evacuated tube, for example, during a blood collection procedure. Accordingly, intravenous puncture tip214is desirably shaped to provide for ease of insertion and minimal discomfort during venipuncture, such as with a tapered pointed end, as is shown in the FIGS. and is known in the art. As depicted inFIGS. 21-25, needle assembly200desirably includes intravenous puncture tip214and non-patient puncture tip216integrally formed as a single structure, such as needle cannula242having a through-hole244for fluid flow therethrough. As such, intravenous puncture tip214and non-patient puncture tip216are integral and extend from opposing ends of cannula242and are in fluid communication with each other. Cannula242may be mounted within internal lumen208of hub202, for example, through a mount272, which may be integrally formed with longitudinal wall206and may extend radially inwardly from an interior surface thereof. Non-patient puncture tip216is further provided with an elastomeric sleeve274extending thereabout, as is generally known in the art.

Needle assembly200further includes a first blunting member246that is in concentric relation about cannula242for extending about intravenous puncture tip214, and a second blunting member248that is also in concentric relation about cannula242for extending about non-patient puncture tip216. In particular, first blunting member246includes a first blunting tip218in concentric relation with and proximate to intravenous puncture tip214, while second blunting member248includes a second blunting tip220in concentric relation with and proximate to non-patient puncture tip216.

Intravenous puncture tip214and first blunting tip218are axially displaceable with respect to each other so as to cause first blunting tip218to blunt intravenous puncture tip214. In a similar manner, non-patient puncture tip216and second blunting tip220are axially displaceable with respect to each other so as to cause second blunting tip220to blunt non-patient puncture tip216. In the embodiment depicted inFIG. 21-25, this is accomplished by providing first blunting member246and second blunting member248as separate members which are axially movable with respect to each other. Such axial movement of first blunting member246and second blunting member248is accomplished through a flexible actuator224.

In particular, a first end250of flexible actuator224is attached to first blunting member246. A second end252of flexible actuator224is attached to second blunting member248. Flexible actuator224is a resilient member extending between first blunting member246and second blunting member248, and interconnecting the two members. Flexible actuator224further extends through opening222of hub202, and may be rotatable within opening222about an axis226defining needle assembly200. Flexing or bending movement of flexible actuator224causes first blunting member246and second blunting member248to axially displace with respect to each other and with respect to intravenous puncture tip214and non-patient puncture tip216, respectively, causing blunting of intravenous puncture tip214and non-patient puncture tip216.

To effectuate the flexing or bending movement of flexible actuator224, flexible actuator224may be rotated within opening222about axis226. For example, flexible actuator224is a resilient member which is in a natural state when flexed, and is in a biased state when bent. As depicted inFIG. 21, flexible actuator224may be biased in a first bent position within first track portion232, including a bent portion228extending through opening222which acts as a handle for enabling rotation of flexible actuator224. In such a position, first blunting member246and second blunting member248are positioned substantially adjacent each other, with intravenous puncture tip214and non-patient puncture tip216exposed from the respective first and second blunting tips218and220.

Bent portion228biases flexible actuator224against opposing surfaces of opening222. In particular, in this first position, a first portion254and a second portion256of flexible actuator224abut respective opposing edges233of first track portion232, with opposing edges233holding flexible actuator224biased in such a bent position against its natural tendency. Thus, opening222holds flexible actuator224therein through compressive force.

In order to activate the blunting feature, flexible actuator224is circumferentially rotated about axis226within opening222. Such rotation causes first portion254of flexible actuator224to travel along first surface236between edge233of first track portion232and edge235of second track portion234, and second portion256of flexible actuator224to travel along second surface238between edge233of first tract portion232and edge235of second track portion234. During such movement, the greater distance between opposing edges235of second track portion234causes flexible actuator224to unbend around bent portion228and to flex or extend within hub202, thereby causing first portion254and second portion256to displace with respect to each other and move away from each other, which in turn causes first blunting member248and second blunting member248to axially displace away from each other. When flexible actuator224is moved entirely within second track portion234, first blunting member246is moved a sufficient axial distance such that first blunting tip218entirely covers intravenous puncture tip214in a protectively shielding manner, and second blunting member248is moved a sufficient axial distance such that second blunting tip220entirely covers non-patient puncture tip216in a protectively shielding manner. As such, both needle tips are effectively blunted.

Intravenous puncture tip214and non-patient puncture tip216may be blunted by first blunting tip218and second blunting tip220, respectively, simultaneously or consecutively. For example, referring toFIGS. 26A and 26B, in order to simultaneously blunt intravenous puncture tip214and non-patient puncture tip216, circumferential track230continuously changes in the distance between first surface236and second surface238from first track portion232to second track portion234. In other words, first surface236and second surface238continuously diverge from a radial centerline240. It is noted that the embodiment ofFIG. 26Bdiffers from that ofFIG. 26Aonly by the inclusion of a peninsula-like portion separating second track portion234into distinct sections.

Referring toFIG. 26C, in order to consecutively blunt intravenous puncture tip214and non-patient puncture tip216, circumferential track230variably changes in the distance between first surface236and second surface238from first track portion232to second track portion234. In other words, first surface236continuously diverges from radial centerline240, however, second surface238runs parallel to radial centerline240for a distance, then diverges from radial centerline240. In such an embodiment, movement of first portion254along first surface236would cause first blunting member246to axially move to a position blunting intravenous puncture tip214prior to second blunting member248blunting non-patient puncture tip216.

As noted,FIGS. 21-25depict needle assembly200with separate first and second blunting members246and248, which are axially movable with respect to each other through flexible actuator224to cause blunting of the respective puncture tips. It is also contemplated that first blunting tip218and second blunting tip220can be integrally formed and extend from opposing sides of a single blunting member, such as blunting member262inFIGS. 27-31. In such an embodiment, intravenous puncture tip214and non-patient puncture tip216are provided as separate members, such as through separate first cannula258and second cannula260. More particularly, blunting member262includes a through-hole264for fluid flow therethrough. First blunting tip218and second blunting tip220extend from opposing ends of blunting member262and are in fluid communication with each other. Intravenous puncture tip214extends from first cannula258that is in concentric relation about blunting member262. Non-patient puncture tip216extends from second cannula260that is also in concentric relation about blunting member262.

First end250of flexible actuator224is attached to first cannula258. Second end252of flexible actuator224is attached to second cannula260. In such an embodiment, blunting member262is maintained as stationary with respect to hub202by being mounted thereto through mount272. As such, the bending of flexible actuator224causes first cannula258and second cannula260to axially displace with respect to each other and with respect to first blunting tip218and second blunting tip220, respectively, causing blunting of intravenous puncture tip214and non-patient puncture tip216.

More particularly, as depicted inFIG. 29, flexible actuator224may be relaxed in a first position within second track portion234, with first cannula258and second cannula260positioned substantially adjacent each other, with intravenous puncture tip214and non-patient puncture tip216exposed from the respective first and second blunting tips218and220. Rotation of flexible actuator224from the second track portion234to first track portion232causes flexible actuator224to bend around bent portion228as inFIG. 27, such that first and second cannulae258and260axially displace with respect to each other and with respect to blunting member262.

Needle assembly200desirably includes structure for attaching needle assembly200to needle holder204that is capable of holding blood collection tubes. For example, hub202may include external threads266for engagement with cooperating internal threads (not shown) on needle holder204. Alternatively, snap fit or other types of attachment mechanisms maybe provided.

Needle assembly200may also be provided with means or structure for attachment of a needle cover (not shown), such as a shoulder270of hub202. Shoulder270is provided for engagement with a needle cover, which covers intravenous puncture tip214prior to assembling of needle assembly200with needle holder204. Shoulder270preferably includes a profile to provide for a frictional engagement with a needle cover, such that the needle cover is maintained in position about shoulder270in a friction fit, thereby covering and protecting intravenous puncture tip214until assembly and use.

Needle assembly200may also be provided with means or structure for preventing relative axial displacement between intravenous puncture tip214and first blunting tip218and between non-patient puncture tip216and second blunting tip220after blunting. For example, in the embodiment ofFIGS. 21-25, the overall length of flexible actuator224may be configured such that flexing or unbending of bent portion228of flexible actuator224causes flexible actuator224to extend entirely within internal lumen208of hub202when moved to the second track portion234, such that flexible actuator224can no longer be grasped for return movement in the opposite direction. Alternately, various other locking mechanisms can be incorporated into the structure to prevent such return movement.

It is further contemplated that relative axial displacement of intravenous puncture tip214and non-patient puncture tip216with respect to first and second blunting tips218and220, respectively, can be accomplished by bending or flexing flexible actuator224within opening222but without any rotational movement about axis216. For example, particularly with respect to the embodiment ofFIGS. 21-25, in a first position flexible actuator224may be bent around bent portion228with first blunting member246positioned adjacent or proximal to second blunting member248, with first and second portions254,256of flexible actuator224being biased against opposing edges233. In order to achieve relative axial displacement of first blunting member246and second blunting member248, direct pressure can be applied radially inwardly against bent portion228, thereby causing bent portion228of flexible actuator224to unbend and flex. This will cause first and second portions254,256of flexible actuator224to ride against opposing edges233and flex or extend into hub202, thereby moving and displacing first and second portions254,256away from each other. This movement also causes first blunting member246and second blunting member248to move axially away from each other and to respective positions effectively blunting intravenous puncture tip214and non-patient puncture tip216.

While the needle assembly of the present invention has been described in terms of one embodiment for use in connection with a blood collection system, it is further contemplated that the needle assembly could be used with other medical procedures, such as in conjunction with a conventional intravenous infusion set, which are well-known in the art for use with conventional needle assemblies.