Tamper evident vacuum tube holder assembly and needle hub assembly therefor

A one piece molded vacuum tube holder is fitted with a one piece molded needle hub assembly. A needle protection device is further rotatably mounted to the neck of the one piece vacuum tube holder. One portion of a locking mechanism is provided at the neck of the one piece vacuum tube holder and a second portion of the locking mechanism is provided at the needle hub of the needle hub assembly, so that when the needle hub assembly is press fit to the vacuum tube holder, the two portions of the locking mechanism will coact to fixedly retain the needle hub assembly within the vacuum tube holder. The one piece vacuum tube holder is configured to have an elongate needle cover integrally extending from its neck. A tamper evident notched joint is provided at the junction where the needle cover is connected to the neck.

FIELD OF THE INVENTION

The following invention relates to a device for holding a fluid container tube such as a vacuum tube, and particularly relates to a vacuum tube holder assembly that is readily manufactured, provides a built in tamper evident seal and has a needle protection housing that securely covers a contaminated needle after use.

BACKGROUND OF THE INVENTION

In U.S. Pat. No. 5,139,489 a vacuum tube holder has attached thereto a protective needle housing which is pivotable to cover an exposed needle of a double-ended needle assembly threaded to the vacuum tube holder. In U.S. Pat. No. 5,154,285, a needle protection housing is mounted to the neck of the vacuum tube holder by means of a collar, so that the housing is rotatable with respect to the neck of the vacuum tube holder. For both of the devices disclosed in the '489 and '285 patents, prior to use and shipping, the double-ended needle is capped at both ends.

Conventionally, a double-ended needle is shipped in a container that covers both ends of the needle. The container is taped with a piece of paper, or other sealing material, to provide evidence that it has not been tampered with prior to use. There has not been any tampering if there is no tear on the paper seal when a phlebotomist takes the double-ended needle out of the container and threads it to the vacuum tube holder or Vacutainer holder. Thus, to use the devices disclosed in the '489 and '285 patents, a user has to first remove the double-ended needle from its container and then thread the double-ended needle to the vacuum tube holder. Moreover, the user has to carry both the double-ended needle and the vacuum tube holder as separate units. The disclosures of the '489 and '285 patents are incorporated by reference herein.

SUMMARY OF THE PRESENT INVENTION

The present invention vacuum tube holder assembly is shipped as a single piece, with the various components preassembled. The vacuum tube holder is a molded one piece component that includes an elongate needle cover that integrally extends from the neck of the body of the vacuum tube holder. At the junction where the elongate needle cover meets the neck of the holder, there is a thinning out of material such as for example by a circumferential notching thereat. When a predetermined torque force is applied to the needle cover relative to either the neck or the body of the vacuum tube holder, the needle cover is readily removed or separated by the twisting motion. Once removed, the needle cover could not be reattached to the neck of the vacuum tube holder. Accordingly, a built in tamper evident seal is provided for the vacuum tube holder of the instant invention, in that a user knows that the vacuum tube holder has been tampered with if the needle cover is missing or is hanging loosely from the neck of the body of the vacuum tube holder.

A needle hub assembly specifically manufactured to be a component of the vacuum tube holder assembly is press fit through the opening of the vacuum tube holder body towards the neck of the vacuum tube holder. The needle hub of the needle hub assembly has a dimension that allows it to mate to the aperture of the neck of the vacuum tube holder which is smaller than the opening of the vacuum tube holder. At the needle hub of the needle hub assembly there are formed two catches that are movable transversely to the needle hub when biased. To enable the transverse movements for the catches, respective through slots are formed in the needle hub behind each of the catches. As the needle hub is press fit to the neck of the vacuum tube container, the catches would first compress, since they are in contact with upward sloping ramps at the inside wall of the neck, in order to pass the aperture of the neck. When the needle hub is pushed sufficiently far into the neck of the vacuum tube holder, openings or orifices formed on the opposite sides of the neck enable the catches, upon mating with those orifices, to return to their original shapes as they latch onto the orifices. Once the catches latch onto their respective orifices at the neck of the vacuum tube holder, the needle hub assembly is fixedly retained within the vacuum tube holder.

There is a raised boss or protuberance circumferentially formed at the outer surface of the neck of the vacuum tube holder. Rotatably mounted to the protuberance is a collar having an internal groove that mates to the protuberance. The tolerances provided for the internal groove of the collar and the protuberance about the neck of the vacuum tube holder during the molding process are such that the friction between the internal groove of the collar and the protuberance would hold the collar in place so long as an external torque force is not applied thereagainst. The collar is therefore not freely rotatable about the neck of the vacuum tube holder. Hingedly connected to the collar is a needle protection housing. Integral hooks are provided in the housing.

The vacuum tube holder assembly therefore includes the vacuum tube holder, the needle hub assembly fitted into the holder and the needle protection housing rotatably mounted to the neck of the vacuum tube holder. The opening at the end of the vacuum tube holder to which a vacuum tube or fluid container is insertable during use may be covered by a seal so that the vacuum tube holder assembly may be readily sterilized and shipped without any need for additional packaging.

DETAILED DESCRIPTION OF THE INVENTION

With reference toFIG. 1, a one piece molded vacuum tube holder2, as shown in cross section, includes a cylindrical body4having an opening6at its one end dimensioned to receive a conventional fluid storage vacuum tube into the cavity8of cylindrical body4. A neck portion10extends integrally from body4. Extending integrally from neck10is an elongate needle cover12. The one piece vacuum tube holder may be formed by molding and may be made from polypropylene.

With reference to bothFIGS. 1 and 2, note that neck10of the vacuum tube holder2has an opening or aperture16at its proximal end merging into cavity8of body4. Aperture16is dimensioned to accept a needle hub such as that shown inFIG. 5, to be discussed more fully later. At the junction where neck10meets with body4, there is an internal recess18to which the base of the needle hub may rest. There are two openings or orifices20aand20bformed at the opposite sides, or 180°, at the wall of neck10. Circumferentially formed about the outer wall surface of neck10, possibly interrupted by orifices20aand20b, is a raised boss or protuberance22to which, as will be discussed later, a collar to which a needle protection housing is hingedly connected, as shown inFIG. 9, is rotatably coupled.

As best shown inFIG. 2, the respective lower portions of orifices20aand20bare formed by lower supports or ledges24aand24b. Ledges24aand24balso form the respective tops of ramps26aand26bthat upwardly extend at an angle from the ceiling of recess18formed at the junction joining body4to neck10. Ramps26aand26bassist in the fitting of the needle hub, as shown inFIG. 5, to neck10, as will be discussed infra.

At the distal end of neck10, i.e., the junction where neck10meets elongate needle housing12, there is a thinning of the material for the vacuum tube holder2. At this weakened junction or joint, designated by the double dotted line28, the thinning may be effected by a circumferential notching of the material so that an inward circumferential notch30is formed at joint28. Although remaining one piece during shipping and before use, due to the weakened joint28, when a predetermined or given torque force is applied to needle cover12relative to either neck10or body4, the elongate needle cover12could readily be separated or removed, at joint or junction28, from the remainder portion of vacuum tube holder12.

Given that the vacuum tube holder2is molded in one piece, once separated, elongate needle cover12could not be reattached to neck10. As a result, weakened joint28provides a tamper evident seal for the vacuum tube holder2. In other words, if there is any kind of breakage at joint28, a user such as a phlebotomist will know that the seal has been broken for that particular vacuum tube holder, and that the needle assembly fitted thereto, to be discussed later, may no longer be sterile or fit for use. To enhance a user's ability to separate elongate needle cover12from body4, a number of elongate ribs32extending longitudinally along the outer surface of elongate needle cover12are provided during the molding process. SeeFIG. 3a.

As best shown in the bottom view ofFIG. 3b, the proximal end of the cylindrical body4is supported by a base34which is configured in a semi-elliptical shape so as to allow the placement of the vacuum tube holder against the body of a patient at either side36aor36b. Sides36aand36bprevent the cylindrical body4from rotating and thereby falling off the body, for example the arm of the patient. In addition to showing opening6,FIG. 3balso shows aperture16of neck10. Moreover, the bottom view ofFIG. 3bshows the two orifices20aand20bformed at neck10.

FIG. 5is a perspective view of a needle hub assembly38that is to be fitted to the vacuum tube holder shown inFIGS. 1-4. With reference also toFIGS. 6 and 7, the needle hub assembly38of the instant invention is shown to have a distal section40and a proximal section42. The distal and proximal sections are formed about a double-ended needle41having one end43, which is to be used to prick a patient, extending from the distal end44of distal section40. The other end of the double-ended needle40, designated46, extends from the proximal end48of proximal section42. Once properly fitted to vacuum tube holder2, needle end43extends into and is covered by elongate needle cover12, while needle end46extends into cavity8of cylindrical body4. Distal section40and proximal section42in combination form the needle hub48of needle hub assembly38.

Needle hub48, at both distal section40and proximal section42, is shown not to be solid, but rather has a number of grooves50. Grooves50are provided in needle hub48to possibly lower the cost of manufacturing by eliminating materials that are not needed and also decrease the weight of the needle hub. Distal section40of needle hub48is dimensioned to have a diameter that fits into the void52(FIG. 2) that extends from aperture16of neck10into the cavity of elongate needle cover12. Proximal section42, on the other hand, is dimensioned to fit into the cavity of neck10as it is introduced into aperture16.

Integrally formed at opposite sides, at 180°, of proximal section42are catches54aand54b. Catches54aand54bare assisted by ramps26aand26b, when needle hub48is press fit to neck10, after needle hub assembly38has been inserted to cavity8of body4. To provide flexibility for catches54aand54bso that catches54aand54bmay move transversely relative to the longitudinal axis of needle hub48, through slots56aand56bare formed in proximal section48substantially behind catches54aand54b, respectively. A better view of the through slots56aand56bmay be had with respect toFIG. 10, which is an enlarged view showing the mating of needle hub48to neck10of the vacuum tube holder. Another view of the through slots56aand56bmay be had with respect toFIG. 7.

Given that distal section40has a smaller diameter than proximal section42, a ledge58is formed circumferentially about needle hub48at the intersection of distal section40and proximal section42. Ledge58abuts against the bottom of internal shoulder60at neck10, as shown inFIGS. 2 and 4, to prevent distal section40from moving further into the cavity of elongate needle cover12, when needle hub48is press fit through aperture16into neck10. Shoulder60is designed with sufficient tolerance to allow catches54aand54bto be snap fitted to orifices20aand20b, respectively, before it abuts ledge58.

Given the space provided by through slots56aand56b, as needle hub48is pushed forward into neck10via aperture16, catches54aand54bare flexibly compressed by ramps26aand26b, until the lowermost portion of those catches move beyond ledges24aand24b. At that point, due to their inherent flexibility, catches54aand54bwould return to their respective original positions with respect to needle hub48so that their respective bottom surfaces60aand60brest on and are supported by ledges24aand24b. In essence, catches54aand54b, acting as one part or portion of a locking mechanism, latch onto orifices20aand20b, respectively, which are acting as another part of portion of the locking mechanism, for fixedly retaining needle hub assembly38within vacuum tube holder2. Once thus latched, needle hub48is fixedly retained in neck10of the vacuum tube holder. To prevent any further forward movement, a base plate62integrally forming the proximal end of proximal section42is dimensioned to fittingly mate with recess18formed at the intersection of neck10and body4. Once mated with recess18, plate62prevents any further forward movement of needle hub48toward neck10.

To enclose needle end46, which extends into cavity8of body4of the vacuum tube holder, a barb64is integrally formed from the proximal end48of proximal section42. A rubber boot66as shown inFIG. 8aand8bis fitted over needle end46, with its upper end68being fixedly held to barb64, as is conventionally known.

With respect toFIGS. 9 and 10, a completely assembled vacuum tube holder assembly is shown to include the one piece molded vacuum tube holder2, the one piece molded needle hub assembly38fitted to and fixedly held within vacuum tube holder2, and a safety needle housing72rotatably mounted about the neck of vacuum tube holder2.

In particular, needle housing72is flexibly or hingedly attached to a collar or ring74by way of a living hinge76. Needle housing72has an elongate slot, not shown, that allows it to pivot over and cover needle end43, while the needle passes through the slot, after elongate needle cover12has been removed from vacuum tube holder2. There are integral hooks78provided in housing72for fixedly grabbing end needle43once housing72has been pivoted to a position in substantial alignment along the longitudinal axis of needle43, or vacuum tube holder2. Needle protection housing72may also be made from polypropylene A more detailed disclosure of a needle protection housing similar to needle protection housing72is given in the aforenoted '285 patent, whose disclosure has been incorporated to the instant specification.

The enlarged view ofFIG. 10shows the needle hub assembly having been fittingly mated to vacuum tube holder2. More specifically, distal section40and proximal section42of needle hub assembly38are shown to have been mated to neck10of the vacuum tube holder and fixedly retained thereat. Moreover, collar74is shown to be rotatably mounted about neck10, at protuberance22, so that collar74, and therefore housing72attached thereto, is rotatable about neck10relative to double-ended needle41. By design, sufficient friction is provided between protuberance22and the internal groove of collar74so that collar74is not freely rotatable. Thus, to rotate housing72, a torque force has to be applied thereto.

As was mentioned before, to assemble, the one piece needle hub assembly38, which may also be made from polypropylene, is first inserted into cavity8through opening6at the proximal end of the cylindrical body4of vacuum tube holder2. Needle hub48of needle hub assembly38is then press fit to neck10of vacuum tube holder2until catches54aand54blatch onto orifices20aand20b, respectively, formed at the opposite sides of neck10. Once catches54aand54bextend out into orifices20aand20b, respectively, their respective bottom surfaces60aand60bwould act against ledges24aand24bof orifices20aand20b, respectively. As a result, the needle hub48could no longer be moved in a backwards direction, i.e., toward opening6of body4. The ledge58formed at the intersection of distal section40and proximal section42of needle hub48and plate62formed at the base of proximal section42prevent further forward movement of the needle hub. Needle protection housing72, by way of collar74connected thereto, is rotatably mounted about neck10of the vacuum tube holder. More specifically, the internal groove of collar74is rotatably mated to the protuberance that circumferentially forms about the outer wall surface of neck10.

To use, a user applies a predetermined torque force to elongate needle cover12relative to neck10or body4to separate the needle cover from neck10of the vacuum tube holder, at weakened joint30. After use and possibly after a vacuum tube inserted into cavity8of body4which is pierced by end needle46has been removed, the contaminated end needle43is fixedly held within needle protection housing72, by the user pivotally moving needle protection housing72towards needle end42until needle end43is grasped by hooks78integral in housing72.

By producing a one piece molded vacuum tub holder, and by press fitting a one piece molded needle hub assembly to the vacuum tube holder, the processing steps for manufacturing the instant inventive vacuum tube holder assembly are made simpler and more economical. If desired, opening6of the vacuum tube holder may be sealed with a material that allows sterilization gas to pass through so that the completely assembled device such as that shown inFIG. 9may be readily sterilized and shipped, without any need for or separate needle cover sheaths and tamper evident warning labels or seals.