Needle holder for use with safety needle assembly

A needle holder for use with a needle assembly for blood collection is provided, and in particular, for use with a needle assembly including an activation mechanism adapted for axial displacement between a first position and a second position with respect to the needle assembly through engagement with a blood collection tube. The needle holder includes an outer body having a first end adapted for attachment to such a needle assembly and a second end having an internal opening therein. The needle holder further includes an inner body slidable within the outer body which includes a mechanism for axially displacing the activation mechanism between the first retracted position and the second activated position. The inner holder may be in the form of a tubular body which is axially slidable within the outer body, or may be in the form of an arm extending through a channel in the outer body, and including a tab for finger activation by a user.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a holder for use with dual end needle assemblies commonly used in blood collection procedures. More particularly, the present invention relates to a needle holder for use with a safety needle for blood collection from a patient and which includes a mechanism for activating the safety feature of the 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 usage. Thus, these blood collection systems allow repeated use of the relatively expensive holder upon replacement of 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 diseases of the blood, methods and devices to enclose the used disposable needle have become very important and in great demand. Many developments have taken place 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 by extending beyond it, so as to eliminate or at least greatly reduce the risk of accidental needle-stick punctures.

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 holder which can be used with a needle assembly which can be activated for safety blunting of the needle 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 needle holder for use in combination with a needle assembly which includes an activation mechanism adapted for axial displacement between a first position and a second position with respect to the needle assembly. The needle holder includes an outer body having a first end adapted for attachment to the needle assembly and a second end having an internal opening therein. The needle holder further includes an inner body slidable within the outer body and including a mechanism for axially displacing the activation mechanism between the first retracted position and the second activated position.

The inner body may be in the form of a tubular body concentric with the outer body. Such a tubular body includes a first end and an opposed second end, with the first end including the mechanism for axially displacing the activation mechanism of the needle assembly between the first retracted position and the second activated position, and the second end including an internal opening for accommodating a blood collection tube therein. Also, the first end of the tubular body of the inner holder may include an opening for accommodating a puncture tip of the needle assembly.

In a further embodiment, the outer body may include a channel extending axially along the outer body, and the inner body may include an arm which projects through the channel of the outer body and is axially slidable within the channel for axial displacement with respect to the outer body. As such, axial displacement of the arm causes the mechanism to axially displace the activation mechanism between the first retracted position and the second activated position. The arm desirably includes a locking mechanism for preventing axial displacement of the activation mechanism from the second activated position to the first retracted position. Also, a tab may be attached to the arm, with the tab adapted for finger activation by a user for causing axial displacement of the inner body within the outer body.

The present invention further includes a blood collection assembly including such a needle holder attached to a needle assembly. As well, the present invention includes a safety collection assembly including a safety needle assembly including an intravenous puncture tip, a non-patient puncture tip, and a blunting member having a blunted tip, said blunting member adapted for axial displacement with respect to the intravenous puncture tip between a first retracted position in which the intravenous puncture tip extends beyond the blunted tip and a second activated position in which the blunted tip extends beyond the intravenous puncture tip. The assembly further includes a needle holder attached to the needle assembly and includes an outer body having a first end adapted for attachment to the needle assembly and a second end having an internal opening therein, and an inner body slidable within the outer body and including a mechanism for engagement with the blunting member for axial displacement of the blunting member with respect to the intravenous puncture tip. The needle assembly may further include a second blunted tip adjacent the non-patient puncture tip, with the blunting member including a first end comprising the first blunted tip and a second opposing end comprising the non-patient puncture tip, and wherein axial displacement of the blunting member with respect to the intravenous puncture tip between the first retracted position and the second activated position also causes axial displacement of the non-patient puncture tip with respect to the second blunting tip between a first retracted position in which the non-patient puncture tip extends beyond the second blunted tip and a second activated position in which the second blunted tip extends beyond the non-patient puncture tip.

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. 1to4illustrate a dual blunting needle assembly in accordance with the present invention and the related features. The needle assembly is in the form of a double-ended needle for use, for example, in combination with a needle holder for collecting blood samples. While the present invention is generally described in terms of a needle assembly, the present invention encompasses a needle assembly as well as a safety assembly which incorporates the needle assembly in combination with a needle holder, as will be discussed in more detail herein.

Needle assembly12of the present invention is shown generally atFIGS. 1-4. Needle assembly12defines a cannula assembly which is adapted for attachment to a separate needle holder, as is known in the art. As such, needle assembly12may be provided with means for attachment to a needle holder, such as attachment threads14which engage a threaded section of the needle holder. In this manner, needle assembly12can be provided as a disposable unit for use with a re-usable holder.

Needle assembly12includes a hub assembly20which defines a partial, generally tubular, housing for needle assembly12. Hub assembly20includes a first external cannula22extending from a first end thereof, with an intravenous puncture tip24at the end of first external cannula22. Hub assembly20further includes a second external cannula26extending from a second, opposing end thereof, with an external blunt tip28at the end of second external cannula26. A central bore or internal lumen30extends through hub assembly20from intravenous puncture tip24to external blunt tip28, providing for the passage of fluid therethrough, and to movably accommodate internal cannula50, as will be discussed in more detail. External blunt tip28is blunted such that, under ordinary hand pressure, will not easily puncture human skin or other biological tissue. Intravenous puncture tip24is provided for insertion into the vein of a patient, 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 Figures and is known in the art.

Desirably, first external cannula22and second external cannula26are provided as separate members which are fixedly adhered to hub assembly20, for example, using a medical grade adhesive. Desirably, first external cannula22is attached to hub assembly20through ferrule46, which attaches directly to first external cannula22and fits within the first end of hub assembly20.

As noted, hub assembly20includes second external cannula26extending from a second end thereof. As best seen inFIG. 1, hub assembly20includes arms32and34, which extend axially along the length of needle assembly12. Arms32and34are separate protrusions which define extensions of the generally tubular body of hub assembly20. Arms32and34are separated, and therefore define channels therebetween for interfitting engagement with a carriage70, as will be discussed in more detail herein.

Bridge member42extends between arms32and34at the second end of hub assembly20. Such bridge member42further defines the general tubular body of hub assembly20, and provides an area for attachment of second external cannula26to hub assembly20. In particular, second external cannula26is fixedly adhered to hub assembly20within internal lumen30at bridge member42, thereby providing second external cannula26as an extension of hub assembly20. In an alternative embodiment, hub assembly20may have arm32and may not have arm34. In a further embodiment, hub assembly20may consist of multiple components. These embodiments may aid assembly of the device.

Needle assembly12further includes internal cannula50. Internal cannula50extends concentrically within internal lumen30of hub assembly20. Internal cannula50includes first end52, with an internal blunt tip54at the end of first end52. Internal blunt tip54is blunted such that, under ordinary hand pressure, will not easily puncture human skin or other biological tissue. Internal cannula50further includes a second end56, with a non-patient puncture tip58at the end of second end56. Non-patient puncture tip58is provided for puncturing of an evacuated tube, for example, during a blood collection procedure. A central bore or internal lumen60extends through internal cannula50from internal blunt tip54to non-patient puncture tip58, providing for the passage of fluid therethrough.

As best depicted inFIG. 2, first end52of internal cannula50is adjacent first external cannula22of hub assembly20, and second end56of internal cannula50is adjacent second external cannula26of hub assembly20. Internal cannula50is axially slidable within the internal lumen30of hub assembly20, such that internal blunt tip54is slidable within first external cannula22and non-patient puncture tip58is slidable within second external cannula26. The inner diameter of first external cannula22is substantially the same as the outer diameter of first end52of internal cannula50, and the inner diameter of second external cannula26is substantially the same as the outer diameter of second end56of internal cannula50. As such, internal cannula50and hub assembly20are dimensioned and configured for a close fit, such that the external diameter of internal cannula50is a close fit with the internal diameter of hub assembly20so that intravenous puncture tip24lies flat on the external surface of first end52of internal cannula50and non-patient puncture tip58lies flat against the internal surface of second external cannula26within internal lumen30when needle assembly12is in an activated position, as shown inFIGS. 3 and 4and described in more detail herein.

It may be desirable to lubricate the mating surfaces of internal cannula50and first and second external cannulas22and26of hub assembly20, 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 petroleum jelly, may be provided about the mating surfaces thereof.

Internal cannula50is adapted for axial movement within internal lumen30of hub assembly20between a first retracted position in which intravenous puncture tip24and non-patient puncture tip58extend beyond internal blunt tip54and external blunt tip28, respectively, and a second activated position in which internal blunt tip54and external blunt tip28extend beyond intravenous puncture tip24and non-patient puncture tip58, respectively. More particularly, axial movement of internal cannula50within internal lumen30of hub assembly20in a direction of arrows100causes first end52of internal cannula50to axially displace with respect to first external cannula22, which causes internal blunt tip54to extend beyond intravenous puncture tip24of first external cannula22. In addition, such axial movement causes second end58of internal cannula50to axially displace with respect to second external cannula26, which causes non-patient puncture tip58to slide within second external cannula26such that external blunt tip28extends beyond non-patient puncture tip58, as depicted inFIGS. 3 and 4. As such, both intravenous puncture tip24and non-patient puncture tip58are simultaneously blunted.

Slidable engagement of internal cannula50and hub assembly20may be effected through carriage70. Carriage70is concentric with internal cannula50, and is provided for slidable engagement with hub assembly20. Carriage70may be integral with internal cannula50, or may be a separate member which is fixedly adhered to internal cannula50such as through the use of an adhesive. Carriage70is defined by a generally tubular body which includes arms72and74extending axially therealong and which are joined at nub80. Arms72and74slidably engage arms32and34of hub assembly20, such that the circumferential profile of needle assembly12about arms72and74of carriage70and arms32and34of hub assembly20is generally cylindrical or tubular, although other shapes or configurations may be apparent to those skilled in the art. In an alternative embodiment, carriage70may have arm72and may not have arm74. In a further embodiment, carriage70may consist of multiple components. These embodiments may aid assembly of the device.

Nub80of carriage70includes a forward portion86which is positioned within the interior portion of hub assembly20when assembled. Forward portion86of carriage70includes a surface78which extends circumferentially about nub80for interference engagement with shoulder38of hub assembly20. Such interference engagement prevents carriage70, and therefore internal cannula50which is attached thereto, from being removed or disassembled from hub assembly20after assembly thereof. Nub80also includes a tapered surface82extending circumferentially thereabout. Tapered surface82provides an interference engagement with hub assembly20, preventing axial displacement of carriage70with respect to hub assembly20without a force exerted thereon, as will be described in more detail herein.

Nub80further includes rear face88which is adapted for engagement with the top surface of a blood collection tube during use. As will be discussed with respect to the use and operation of needle assembly12, rear face88provides a mechanism for activating needle assembly12, thereby axially displacing internal cannula50with respect to hub assembly20between a first retracted position and a second activated position.

Internal cannula50and hub assembly20may be reversibly axially displaceable with respect to each other, such that internal cannula50may displace with respect to hub assembly20from either the first retracted position to the second activated position or from the second activated position to the first retracted position. In preferred embodiments, internal cannula50is axially displaceable with respect to hub assembly20in only a single direction from the first retracted position to the second activated position. As such, needle assembly12may be provided with means for preventing axial displacement of internal cannula50from the second activated position to the first retracted position once it has been activated, such as a locking mechanism. For example, nub80may further include a surface84which extends circumferentially about nub80for interference engagement with shoulder38of hub assembly20after activation of needle assembly12from the first retracted position to the second activated position. Such interference engagement prevents axial movement of carriage70with respect to hub assembly20in a direction opposite arrows100after movement from the first retracted position to the second activated position.

Needle assembly12may be further provided with means for indicating movement of internal cannula50within hub assembly20between the first retracted position and the second extended position. Such means may be a visible, audible and/or tactile indicator, identifying movement of internal cannula50within hub assembly20between the first retracted position and the second extended position. For example, in one particular embodiment, hub assembly20may be provided with a channel36extending through the body thereof. Channel36is provided within hub assembly20and extends through the wall thereof to the external portion of needle assembly12. Carriage70includes finger76which extends from forward portion86of nub80within channel36of hub assembly20. Axial movement of carriage70with respect to hub assembly20causes finger76to axially slide within channel36of hub assembly20. Upon axial movement of carriage70from the first retracted position shown inFIGS. 1-2to the second activated position shown inFIGS. 3-4, finger76extends within channel36and through the wall of hub assembly20, thereby providing an indication that needle assembly12has been activated, or blunted.

Channel36preferably extends through hub assembly20at a position which is beyond the point of attachment to a needle holder, such as threads14, to ensure that such an indicator is visible to the user during operation and use. Moreover, finger76may be provided with a visual identification, such as a color code or verbiage to indicate activation of needle assembly12.

Hub assembly20may further be provided with a means for attachment of a needle cover, such as shoulder16at the first end thereof. Shoulder16is provided for engagement with a needle cover (not shown), which covers intravenous puncture tip24of first external cannula22prior to use of the needle assembly12with a patient. Such a needle cover may be constructed of rigid polymeric material, as is known in the art. Shoulder16preferably includes a profile to provide for a frictional engagement with the needle cover, such that the needle cover is maintained in position about shoulder16in a friction fit, thereby covering and protecting first external cannula22and intravenous puncture tip24until assembly and use.

Also, needle assembly12may be provided with a second needle cover (not shown) for covering non-patient puncture tip58of second external cannula26prior to assembling of needle assembly12with a needle holder. Such a second needle cover may also be constructed of rigid polymeric material. This second needle cover may be attached to needle holder12, for example, by threaded engagement with external threads14extending about hub assembly20. In this manner, this second needle cover can be removed from needle assembly12prior to assembly with a needle holder by unthreading the needle cover from external threads14, and then threading external threads14into an internal thread of such a needle holder, as is known in the art.

Needle assembly12is further provided with an elastomeric sleeve90extending about second external cannula26and second end56of internal cannula50, and covering non-patient puncture tip58, as is generally known in the art. Elastomeric sleeve90is joined to bridge member42. This joining means may be an interference mechanism, a snap-fit, an adhesive, or other such similar means.

In a further embodiment, the present invention is directed to a safety assembly which includes needle assembly12in combination with a needle holder110, as shown inFIGS. 5 and 6. Needle holder110may be a conventional needle holder as is well known in the art for use in connection with double-ended needles for blood collection. For example, needle holder110is defined generally by hollow body112, which includes first end114, and second end118. First end114of needle holder110includes an opening116extending therethrough, while second end118includes flange122and is generally open-ended, providing needle holder110with a hollow body112having an internal opening120extending therethrough. Such internal opening120accommodates a blood collection tube130during a sampling procedure, such as an evacuated collection tube, as is known in the art.

Means for attachment are provided for attaching needle assembly12to needle holder110, such as within internal opening116at first end114. Such attachment may be accomplished, for example, through a snap-fit engagement, or more desirably, through a threaded relation, such as through internal threads within opening116for engagement with external threads14of needle assembly12.

Operation and use of the needle assembly of the present invention will now be described in terms of the embodiment depicted inFIGS. 1-4. In use, needle assembly12is provided including a first needle cover (not shown) extending over first external cannula22, and a second needle cover (not shown) extending over second external cannula26. When preparing the needle assembly for use in a sampling procedure, the second needle cover is removed from second external cannula26, and needle assembly12is then attached to needle holder110, such as by threading external threads14with internal threads provided within opening116of needle holder110.

The needle cover extending over first external cannula22is then removed. Venipuncture is then conducted in known manner, whereby intravenous puncture tip24is inserted into a vein of a patient, and evacuated blood collection tube130having pierceable closure132is inserted into the needle holder, such that pierceable closure132of the collection tube130contacts sleeve90extending about second external cannula26. When slight pressure is exerted on the collection tube130, pierceable closure132contacting sleeve90causes sleeve90to displace, thereby causing non-patient puncture tip58to puncture sleeve90and, in turn, pierceable closure132. At such time, the interior of collection tube130and internal lumen60of internal cannula50are in fluid communication. Since the interior of collection tube is at a negative pressure, blood is drawn from the vein of the patient, through internal lumen30of first external cannula22, through internal lumen60of internal cannula50and into collection tube130.

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 puncture tip24of first external 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 exerting pressure in a direction of arrows100on rear face88of carriage70.

In particular, during sampling, the top surface of pierceable closure132of collection tube130contacts rear face88of carriage70within the holder. When additional force is exerted against collection tube130in a direction of arrows100, rear face88is forced in the direction of arrows100. Such force causes interference engagement between tapered surface82of nub80against hub assembly20. Since hub assembly20includes groove40at opposed portions of the wall thereof, hub assembly20radially displaces to permit tapered surface82to pass within hub assembly20, thereby causing axial movement of carriage70with respect to hub assembly20. Moreover, since arms72and74of carriage70interfit with arms32and34of hub assembly20, carriage70is able to axially slide with respect to hub assembly20.

Since carriage70is attached to internal cannula50, axial displacement of carriage70with respect to hub assembly20causes axial displacement of internal cannula50with respect to hub assembly20. Moreover, since first external cannula22and second external cannula26are attached to hub assembly20, axial displacement of internal cannula50with respect to hub assembly20causes first end52and second end56to axially displace with respect to first external cannula22and second external cannula26. Since internal blunt tip54and external blunt tip28are positioned short of intravenous puncture tip24and non-patient puncture tip58, respectively, axial displacement of first end52and second end56with respect to first external cannula22and second external cannula26causes internal blunt tip54and external blunt tip28to axially displace to a position in which they extend beyond intravenous puncture tip24and non-patient puncture tip58, respectively. More particularly, when internal cannula50is axially displaced in the direction of arrows100, internal blunt tip54protrudes from the end of first external cannula22beyond intravenous puncture tip24, and non-patient puncture tip58slides within second external cannula26such that external blunt tip28extends beyond non-patient puncture tip58, as depicted inFIGS. 3 and 4. As such, both intravenous puncture tip24and non-patient puncture tip58are simultaneously blunted. Needle assembly10can then be removed from the patient's vein, and appropriately discarded.

As noted, the safety assembly of the present invention includes needle assembly12used in connection with a needle holder110, which may be a standard needle holder known for use with conventional double-ended needle assemblies for blood collection. Desirably, the safety assembly includes a needle holder which is particularly designed for use in connection with a needle assembly having an activation mechanism such as a blunting member adapted for axial displacement between a first retracted position and a second activated or blunted position, such as needle assembly12of the present invention. In particularly preferred embodiments, needle holder110includes a mechanism for causing axial displacement of internal cannula50within internal lumen30of hub assembly20.

For example, as depicted inFIGS. 7-11, the safety assembly may include a needle holder which includes a lever for preventing or permitting activation of needle assembly12. In particular, as shown inFIGS. 7-9, needle holder110ais provided. Needle holder110aincludes a generally tubular hollow body112a, including first end114aand second end118a. First end114aof needle holder110aincludes an opening116aextending therethrough, while second end118aincludes flange122aand is generally open-ended, providing needle holder110awith a hollow body112ahaving an internal opening120aextending therethrough. Such internal opening120aaccommodates a blood collection tube130during a sampling procedure, such as an evacuated collection tube, as is known in the art.

Means for attachment are provided for attaching needle assembly12to needle holder110a, such as within internal opening116aat first end114a. Such attachment may be accomplished, for example, through a snap-fit engagement, or more desirably, through a threaded relation, such as through internal threads within opening116afor engagement with external threads14of needle assembly12.

Needle holder110ais further provided with a lever140aextending along a portion of hollow body112athereof. Lever140ais provided as a generally elongated portion extending axially along the exterior portion of hollow body112a. Lever140aincludes extension arm142aextending from one end thereof. Extension arm142aextends through the wall of hollow body112aof needle holder110a, and within internal opening120aof needle holder110a. Extension arm142aincludes surface148a, which is provided for interfering engagement with a top surface of collection tube130such as pierceable closure132.

Lever140ais movable between a first blocking position and a second release position. More particularly, lever140ais provided in a first position in which lever140alies flush with the outer surface of hollow body112aof needle holder110a, such that lever140arepresents a continuation of the outer surface of hollow body112aof needle holder110a. In such a first position, extension arm142aextends within internal opening120afor interfering or abutting engagement with pierceable closure132of a collection tube130inserted within internal opening120a. In such a first position, collection tube130is blocked from engagement with carriage70to prevent axial displacement of carriage70, and therefore prevent axial displacement of internal cannula50with respect to hub assembly20between the first retracted position and the second activated position.

Lever140ais movable in a direction of arrow102ato a second release position, in which lever140aprotrudes from the outer surface of hollow body112aof needle holder110a. In such a second position, extension arm142ais moved out of interfering or abutting engagement with pierceable closure132of collection tube130within internal opening120a. As such, collection tube130is permitted to engage with carriage70. Application of force on collection tube130such as by pushing collection tube130further within internal opening120aof needle holder110acauses engagement of pierceable closure132against surface88of carriage70. Such engagement results in axial displacement of carriage70, and therefore axial displacement of internal cannula50with respect to hub assembly20between the first retracted position and the second activated position, as discussed above. As such, lever140aprovides a blocking mechanism for preventing axial displacement of internal cannula50with respect to hub assembly20, and therefore for preventing blunting of needle assembly12, until a desired time.

Movement of lever140abetween the first blocking position and the second release position may be provided through hinge146a. Hinge146ais depicted inFIGS. 7-9at first end114aof needle holder110a. Lever140amay be provided as a separate member which is attached to hollow body112aof needle holder110aat hinge146a. More desirably, lever140ais integrally formed with hollow body112aof needle holder110a. For instance, lever140amay be provided as a cutaway portion of hollow body112a, with lever140aand hollow body112abeing interconnected through hinge146a.

Lever140afurther includes tab144a, which is provided for moving lever140abetween the first blocking position and the second release position. Tab144amay be provided at a position adjacent first end114aof needle holder110a, with tab144aextending from hollow body112a, to a position adjacent the connection between needle holder110aand needle assembly12. In this manner, tab144acan be activated by applying pressure in a direction of arrow102a, such that tab144adeflects, thereby activating and moving lever140abetween the first blocking position and the second release position, as shown in FIG.9.

In a further embodiment shown inFIGS. 10 and 11, needle holder110bincludes hollow body112bincluding first end114bhaving opening116band second end118bhaving flange122b, and internal opening120bextending therethrough. Needle holder110bincludes a pair of levers150band160bin a similar manner as lever140ashown in the embodiment ofFIGS. 7-9. In particular, first lever150band second lever160binclude tabs154band164b, extension arms152band162band surfaces158band168b, respectively. First lever arm150band second lever arm160bextend along opposing sides of hollow body112bof needle holder110bwithin channels124band126brespectively. In such an embodiment, first lever150band second lever160bmay extend away from hollow body112bin a flaring manner, with tabs158band168bpositioned adjacent second end118bof needle holder110b.

Movement of first lever150band second lever160bbetween the first blocking position and the second release position can be accomplished through activation of tabs154band164bby applying pressure in a direction of arrow170band172b. As such, tab154band164bdeflect, thereby causing extension arms152band162bto deflect outward in a direction of arrows174band176b, respectively. Such deflection moves first and second levers150band160bbetween the first blocking position and the second release position, thereby releasing collection tube130from the blocked position. As such, collection tube130can be forwarded in a direction of arrow178b, thereby activating needle assembly12through engagement between pierceable closure132and carriage70, as described above. In an alternative embodiment, needle holder160bmay have lever150band may not have lever160b.

In a further embodiment, the needle holder may be provided with a mechanism for activating the blunting mechanism of the needle assembly, such as by axially displacing the internal cannula within the internal lumen between the first retracted position and the second activated position. For example, the needle holder may include a rotational mechanism including an internal cam assembly for blunting of an intravenous puncture tip of a needle assembly. Desirably, such a mechanism is adapted for engagement with the carriage for axially displacing the internal cannula.

Examples of particularly desirable embodiments of such needle holders are depicted inFIGS. 12-21. In the embodiment depicted inFIGS. 12-17, a needle holder110cincludes an outer body180efor attachment to a needle assembly, such as needle assembly12as described hereinabove. Outer body180cincludes a first end182cadapted for attachment to needle assembly12, and an open-ended second end184c, with an interior space186cwithin outer body180eextending from first end182cto second end184c. Needle holder110cfurther includes a mechanism extending within interior space186cof outer body180cfor engagement with carriage70of needle assembly12, for causing said axial displacement of internal cannula50between the first retracted position and the second activated position. As shown inFIGS. 12-14, such a mechanism may be in the form of an inner body190cwhich is concentric with and extends within interior space186cof outer body180cthrough second end184c.

Inner body190cis in slidable engagement within outer body180c. Inner body190cincludes first end192cwhich extends within interior space186cof outer body180c, and second end194cwhich protrudes from second end184cof outer body180c. Inner body190cfurther includes an interior space196c, which is adapted for accommodating a blood collection tube therein for sampling procedures, as described hereinabove.

Activation of the blunting feature of needle assembly12can be accomplished in such an embodiment by sliding inner body190cwithin outer body180cin a direction of arrow200. Such sliding forces first end192cof inner body190cto engage carriage70at rear face88, thereby forcing carriage70to move in the direction of arrow200, which activates the blunting feature of needle assembly12, as described in detail above. Sliding of inner body190cwithin outer body180ccan be easily accomplished by the user with slight pressure exerted on second end194cof inner body190cin the direction of arrow200.

It is noted that inner body190cmay alternatively be in rotational engagement within outer body180c, such as through interrelating and mating threads on an outer surface of inner body190cand an inner surface of outer body180c. As such, activation of the blunting feature can be achieved by rotating inner body190cwithin outer body180csuch as by screwing the mating threads, thereby screwing inner body190cwithin outer body180cin a direction of arrow200.

As shown clearly inFIGS. 12-14, outer body180cmay further be provided with an opening188cextending through the wall thereof. In addition, inner body190cmay be provided with a protrusion such as finger198c, which is adapted for engagement within opening188cof outer body180cwhen inner body190cis slidably moved in the direction of arrow200. Such engagement between finger198cand opening188cprovides holder100cwith a locking feature, wherein inner body190cis prevented from slidably moving within outer body180cin a reverse direction once moved in the direction of arrow200. As such, inner body190cis locked in place within outer body180c, which in turn locks carriage70of needle assembly12in place, thereby effectively locking needle assembly12in the second extended position for blunting.

Moreover, activation of the blunting feature of needle assembly12can be accomplished by sliding inner body190cwithin outer body180cby way of cooperating features of inner body190cand outer body180c. For example, outer body180cmay include a channel202cextending axially along an outer surface thereof, as depicted inFIGS. 15-17. Channel202cdesirably includes an expanded opening204cat first end182cof outer body180c. First lip206cextends at a first position within channel202c, while second lip208cextends at the juncture of channel202cand opening204c. Inner body190cincludes tab210cextending from an outer surface thereof. For example, inner body190cmay include a cutaway portion212c, which flexes upon application of force. Tab210cis integrally formed with cutaway portion212c, with shoulder214cextending therebetween.

Channel202caccommodates tab210cin slidable engagement therein. In a first position such as during sampling, shoulder214cis in interference engagement with first lip206c. When activation of the blunting feature of needle assembly12is desired, tab210cis depressed, which flexes cutaway portion212cwithin interior space196cof inner body190c, thereby releasing shoulder214cfrom interference engagement with first lip206c. Forward slidable movement of inner body190cwithin outer body180ccan then be accomplished through movement of tab210c. Once tab210cis moved to a position adjacent opening204c, tab210cflexes upward such that tab210cextends outward through opening204c. Shoulder214cis then in interference engagement with second lip208c, thereby providing a locking feature, wherein inner body190eis prevented from slidably moving within outer body180cin a reverse direction.

Yet a further needle holder embodiment is depicted inFIGS. 18-21. Such a needle holder110dincludes a tubular hollow body in a similar manner as tubular hollow body112which is described above with respect toFIGS. 5 and 6, with a slot220dextending therethrough. Needle holder110dfurther includes a mechanism222dwhich extends through slot220d. Mechanism222dis adapted for engagement with carriage70of a needle assembly, for axially displacing the internal cannula of the needle assembly as described above.

Mechanism222dincludes a tab224dadapted for finger activation by a user. Mechanism222dfurther includes extension226dwhich extends from tab224dthrough slot220d. Extension226dincludes surface228dfor engagement with carriage70of a needle assembly. Activation of the blunting feature of needle assembly12can be accomplished in such an embodiment by sliding mechanism222din a direction of arrow300. Such sliding forces surface228dof mechanism222dto engage carriage70at rear face88, thereby forcing carriage70to move in the direction of arrow300, which activates the blunting feature of needle assembly12, as described in detail above. Sliding of mechanism222dcan be easily accomplished by the user with slight pressure exerted on tab224din the direction of arrow300.

As shown clearly inFIG. 21, holder110dmay be provided with a locking feature, wherein mechanism222dis prevented from slidably moving in a reverse direction once moved in the direction of arrow300. This may be accomplished by providing opening230d, and providing mechanism222dwith a finger232don an underside thereof. Such finger232dis provided for interference engagement with the edge of opening230d, thereby providing a locking feature, wherein mechanism222dis prevented from slidably moving in a reverse direction.

It is noted that the needle holders described above, particularly in connection withFIGS. 11-21, can be used with any needle assembly which includes an activation mechanism such as a blunting member adapted for axial displacement between a first retracted position and a second activated or blunted position. Accordingly, such needle holders can be used with needle assemblies which include a double blunting needle, such as needle assembly12described above, as well as needle assemblies which include only a single blunting needle.

The needle assembly of the present invention 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 can be selected which will provide the proper support for the structure of the invention in its use, and which will also provide a degree of resiliency for the purpose or providing the cooperative relative movement.

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, as which are well known in the art for use with conventional needle assemblies.