NEEDLE PROTECTED ASSEMBLY
FIELD OF THE INVENTION The present invention relates to a protective guard for a needle and, more particularly, to a protected needle assembly, which includes the center of the needle, and allows to use this needle in a syringe, needle holder or another device that handles fluids. Description of Related Information In medicine, sharp pointed needles are used in many procedures. Devices that have sharp pointed needles are used to deliver fluids to patients, either directly or intravenously, and in various blood collection applications, or with syringes or with specialized holders to fill evacuated tubes. Since needles are widely used in medical procedures, many people are potentially exposed to these needles in the routine course of their work. These exposures to needles are not limited only to professionals directly involved in the treatment of patients, but also include auxiliary workers throughout the hospital. These auxiliary workers include the pharmacy technicians of the hospitals, who prepare the doses and the hospital service personnel, such as in the laundry, housework, etc. The problems of exposure to needles are not limited just to needle puncture which have already been used. Hospital pharmacy workers often prepare syringes with expensive medication doses, coat the syringe and transport it with the dose to the patient. If the pharmacy worker inadvertently stings himself or damages the needle, the syringe and dose will probably no longer be used. Exposure to blood borne pathogens is a danger recognized by anyone associated with medicine. As a result of this recognition, numerous protocols for the use of needles have been developed and widely practiced. The problem of transmission of blood borne pathogens not only exists for the doctor, nurse or phlebotomist who uses the needles, but also for the auxiliary workers throughout the hospital. The protocols of use dictate generally in detail when and how a needle should be used and how it should be discarded. The problem with many protocols for needle handling is that they often require users to perform additional steps in a procedure. With the pressure of time and a simple oversight, certain practices regarding the handling of used needles are sometimes overlooked and injuries can occur. The medical device industry has responded to the problem by producing a wide variety of needle picking devices, needle guard devices and the like, to assist professionals in their needs to reduce the occurrence of needle injuries. Many devices have been developed to protect needles after use and to avoid exposing people to used needles. A representative list of many of these devices is found in United States of America 4,982,842 to Hollister et al. Hollister et al. , discloses a stop adapter having a male and female end for correspondence with a needle assembly and the ejection end of a syringe. The device of Hollister et al. , includes a housing mounted to the adapter, which can rotate to a position in alignment with the needle to wrap this needle and lock and retain it within the housing. The device of Hollister et al. , increases the unusable volume or "dead space" of the device on which the adapter is mounted and requires an additional part that increases the projection of the needle shaft. Likewise, if the bevel position is important for the intended use of the needle, the invention of Hollister et al. , it must be carefully aligned with the tip of the needle when it is mounted. The patent of the United States of America 5, 207,653 to Janjua et al. , reveals a needle cover with a longitudinal groove, which has a width greater than the width of a needle. According to Janjua et al. , the needle cover is adapted to be pivotally connected with the needle and shaft part. Janjua et al. Also disclose that the needle cover can be used with a syringe or with a needle holder for fluid collection tubes. The device disclosed by Janjua et al. , it is mounted on the shaft of the needle with a pivot, but, since it only pivots in one plane, unless the needle tip is oriented precisely with the shaft during assembly, the guard may interfere in some applications. Many of the devices listed in the background of the Hollister et al. , in the own invention of Hollister et al and in the invention of Janjua et al. , they try to address the recognized need to protect the medical staff and service of needle bites. There are several recurring problems to varying degrees with these devices. Many of these previous devices are somewhat complex and thus significantly more expensive than an unprotected device. Other of these prior devices also increase the complexity or increase the difficulty of performing a procedure. Some of the previous devices are specific procedures and thus prevent the use of them in certain other procedures. For these and other similar reasons, many of the devices disclosed in the background of Hollister et al. , have never been successful in trade. The extraction of blood is an application that is particularly sensitive to the orientation of the needle tip. Many phlebotomists carefully align the tip of the needle with the bevelled face away from the skin, so the placement of the needle tip must be precisely controlled. A needle assembly as disclosed by Janjua et al. , is sometimes uncomfortable to use because the protector is sometimes on the road or, alternatively, more expensive, due to the need to carefully guide the tip during manufacturing. Additionally, in the Janjua et al. , while there is an acknowledgment of the need to secure the lid in the closed position on the needle, all proposed solutions require additional steps, such as securing the lid with an adhesive or by twisting this lid. Although many devices with protected needles already exist, there is still a need for a protected needle device that is easily manufactured, can be applied to many types of fluid handling devices, as well as being simple and intuitive to use. Additionally, the water device must not interfere with normal usage practices. Such a device is described in the following. SUMMARY A needle assembly of the present invention includes an elongated needle, having a proximal end, a distal end and a passage therethrough, defining an axis. The assembly has a needle center with a proximal end, a distal end and an outer surface. This needle center has an axial bore through it, to receive and retain the needle and the distal end is axially projected. The proximal end of the needle center can be removably mounted on a fluid handling device. The assembly includes an elongated guard, with an open proximal end, a distal end and a side wall, with an internal surface defining a cavity. The side wall has an elongated opening within the cavity, from approximately the distal end to the proximal end. There is a hinge that includes a mounting to hold the cover over the center. This assembly includes an opening, which is of such size and configuration to receive at least a portion of the center of the needle. The hinge allows pivoting movement displaced from the shaft between an initial closed position, which substantially prevents inadvertent access to the needle, an open position, in which at least the distal point of the needle is exposed and a locked position, in which the guard is in contact with the needle, where the assembly is locked and prevents substantially access to the distal point of the needle. The assembly also has a removable cover, which is disposed over the elongated opening in the guard and engages this guard to retain it in the initial closed position. The cover can be removed by a distal axial movement that opens the guard, disengages the cover from this guard and exposes at least the distal point of the needle. There is a latch to lock the guard to the assembly, when this guard is locked. The profenals find that the protected needle assembly of the invention is intuitive in its use. To expose the needle for use, the practitioner simply grabs the cover and pulls it distally. The cover can then be discarded, just as is done with the guarding of a conventional protected needle. Removal of the cover causes the needle guard to pivot and open and expose this needle for use. After the cover is removed, it can be replaced to protect the needle for transport to the treatment location, without the guard closed. This ability to protect the needle after opening is important for hospital pharmacy applications, ie where the syringe is filled and must be transported to a remote location for use. Since the guard partially opens, it is evident in visual form that the syringe is being used. When the practitioner has completed the procedure with the needle, the guard locks simply by pivoting the needle over the needle until it touches the needle and locks. During the lock, the doctors do not need to place their hands beyond the tip of the needle, the guard closes and locks easily, with the profenal's hands placed proximal to the tip of the sharp needle. BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a perspective view, partially in separate pieces, of the preferred needle protected assembly of the present invention.; Figure 2 is a perspective view of the assembly of the invention as manufactured, mounted on a fluid handling device and sealed in a package; Figure 3 is a perspective view of the assembly of the invention mounted on a fluid handling device, illustrating the removal of the cover and guard in a partially open position;
Figure 4 is a perspective view of the assembly of the invention, mounted on a fluid handling device and with the guard completely open; Figure 5 is a perspective view of the assembly of the invention mounted on a fluid handling device and with the guard in the closed position; Figure 6 is a partial, longitudinal cross-sectional view of the assembly of the invention mounted on a fluid handling device, taken from Figure 2, along line 6-6; Figure 7 is a cross-sectional view of the assembly of the invention, taken from Figure 1, along line 7-7; Figure 8 is a top plan view of the cover portion of the assembly of the invention; Figure 9 is a cross-sectional view of the cover portion of the assembly of the invention, taken from Figure 8 along the line 9-9; Figure 10 is a proximal end view of the cover portion of the assembly of the invention; Figure 11 is a bottom plan view of the guard portion of the assembly of the invention;
Figure 12 is a cross-sectional view of the guard portion of the assembly of the invention, taken from Figure 11, along line 12-12; Figure 13 is a proximal end view of the guard portion of the assembly of the invention; Figure 14 is a partial cross-sectional view of the assembly of the invention mounted on a fluid handling device, with the partially opened guard, taken from Figure 3, along the line 14-14; Figure 15 is a partial cross-sectional view of the assembly of the invention, mounted on a fluid handling device, with the guard completely open, taken from Figure 4, along line 15-15; Figure 16 is a partial cross-sectional view of the assembly of the invention, mounted on a fluid handling device, with the guard closed, taken from Figure 5, along line 16-16; Figure 17 is a cross-sectional view of the assembly of the invention, taken from Figure 1, along line 17-17;
Figure 18 is a cross-sectional view of the assembly of the invention, analogous to Figure 17, having the assembly rotated with respect to the center of the needle; Figure 19 is a cross-sectional view of the assembly of the invention, taken from Figure 5, along line 19-19; Figure 20 is a partial cross-sectional view of the assembly and center portion of the assembly of Figure 1; Figure 21 is a partial cross-sectional view of the assembly and the center portion of an embodiment of the invention, analogous to the view of Figure 20; Figure 22 is a partial cross-sectional view of the assembly and center portion of another embodiment of the invention, analogous to the views of Figures 20 and 21;
And Figure 23 is a perspective view, with separate pieces, of an embodiment of the invention, suitable for mounting on a needle holder. Detailed Description While this invention is satisfied by the embodiments in many different forms, preferred embodiments of the invention are shown in the drawings and are described herein in detail, but it should be understood that the present disclosure will be considered as exemplary of the principles of the invention. and it is not intended to limit the invention to the illustrated embodiments. The scope of the invention is measured by the appended claims and their equivalents. In this description, a convention is followed, in which the term "proximal" refers to the portion of the device closest to the professional and the term "distal" refers to the portion of the device that is remote from the professional. Referring to Figures 1 to 20, a needle assembly 10, according to the present invention, includes an elongate needle 12 with a proximal end 14, a distal end 16 and a passage 18 through them, which defines an axis A. The assembly 10 includes a needle center 20 with a proximal end 22, a distal end 24 and an outer surface 26. The needle center 20 has an axial bore 28 for receiving and retaining the needle 12, with the distal end 16 of the needle, which preferably has a sharp point 17, projecting axially. The proximal end 22 of the needle center can be releasably mounted, preferably with a female holder mounted on a fluid handling device, such as a syringe 30. The assembly 10 has an elongated guard 32 with an open proximal end 34. , a distal end 36 preferably closed and a side wall 38 with an inner surface 40 and an outer surface 41 defining a cavity 42. The side wall 38 has an elongated opening 44 within the cavity 42 from approximately the distal end 36 to the end proximal 34. The assembly 10 has a hinge 46 that includes a mounting 48 for retaining the guard 32 over the center 20, this assembly 48 also includes an opening 49, having such dimension and configuration for receiving at least a portion 53 of the center 20 of the needle. The guard 32 can be moved along the hinge 46 by a pivoting movement offset from the axis, between an initial closed position, better seen in Figures 2 and 6, where inadvertent access to the needle 12 is substantially prevented, an open position, better seen in Figures 3, 4, 14 and 15, where at least one acute distal tip 17 of the needle is exposed, and a closed position, better seen in Figures 5, 16 and 19, where the guard it is in contact with the needle 12, it is locked to the assembly 48 and substantially prevents access to the acute distal tip 17 of the needle. The assembly 10 has a removable cover 50, which is disposed over the elongated opening 44 in the guard 32 and engages this guard 32 to retain it in the initial closed position, better seen in Figures 2 and 6. The cover 50 can be Removing by a distal axial movement, illustrated in Figure 3, to open the guard 32, to uncouple the cover 50 from the guard and expose at least the acute distal tip 17 of the needle. The assembly 10 has a latch 52 for locking the guard 32 to the assembly 48, when the professional ends with the needle 12. The latch 52 is formed by engaging at least one pawl 54, preferably two pawls 54, located in a projection 56 to the outside from the assembly 48 and at least one slit 58, preferably two slots 58 in the guard 32. The pawls 54 and slits 58 are arranged to engage when the guard 32 moves pivotally about the hinge 40 in contact with the needle 12. The closed position of the mounting guard is best seen in Figure 16, and the engagement of the pawls 54 and the slits 58 are shown in Figure 19. The hinge 46 is formed by two arms 60, projecting proximally from the proximal end 34 of the opening 44 opposite the guard, and each arm 60 has a hole 62. The projection 56 to the outside is arranged and is sized to fit between the arms 60 and has two pins 64, which they extend outwards, which are of a size and arrangement to fit in the holes 62 to form a pivot and to attach the guard 32 to the assembly 48. This guard 32 can be pivotally moved about the hinge 46 with respect to the assembly 48. The projection 56 also has a cantilevered spring 66, which is arranged to engage a support 67 on the inner surface 40 of the guard 32 and provide a resistance to movement of the guard 32 to the closed position. Preferably, the cantilever spring 66 is formed integrally with the assembly 48 as a single manufacturing unit, to simplify the assembly and increase the efficiency of the manufacturing process. The guard 32 also includes two raised, proximal retaining areas 70 on an outer surface 72 of the side wall 38 adjacent the opening 44. The raised retaining areas 70 are arranged to be engaged by two rails 69 on a interior surface 51 of deck 50, to retain this cover on the guard, when the assembly is in the initial closed position, as seen in Figures 2 and 6. The cover 50 further includes at least one protrusion 73 on the inside, which is arranged to be coupled to an edge proximal 74 of the raised retention area 70, so that when the cover 50 moves axially distally, the engagement of the protuberance 73 and the proximal edge 74 causes the guard 32 to pivot about the hinge 46 and move to the open position, as seen in Figure 3. Once the cover 50 is removed, it can not easily be replaced with the guard in the initial closed position, because once the guard 32 moves from the closed position Initially, the cantilevered spring 66 provides a resistance to the closing guard, unless it is sufficiently closed to engage the pawls 54 and the slots 58, and lock the guard onto the assembly. However, the cover 50 can be replaced in the assembly to cover the needle 12, after the syringe has been opened and filled to allow the assembly to be transported to a remote location where the dose is administered. The ability to remount cover 50 with guard 32 open is particularly useful in hospital pharmacy applications, where a dose is prepared for a patient at a remote location from the administration location. Once the dose is administered, the professional then Proceed with the lock of the receipt. The engagement of the pawls 54 with the slits 58 is best seen in Figure 19. During the manufacturing process, since the spring 66 provides resistance to the closure of the guard, an assembly step is required which causes the bending of the spring 66. This deflection of the spring 66 during manufacture is illustrated in Figure 7. The support 67 extends into the cavity 42 to engage the spring 66. During manufacture, the cover 50 is placed over the guard 32 and a tool 76 ( shown in silhouette in Figure 7) is positioned to enter the access door 77 in the shelter 32, to bend the spring 66 (shown schematically in silhouette in Figure 7). The cover 50 retains the guard 32 in the initial closed position. When the tool 76 is removed with the guard 32 in the initial closed position, the spring 66 is in the support position (better seen in Figure 6), where it is not under tension with the backrest 67. As the cover 50 is removed and the guard opens, the backrest 67 moves past and bending the spring 66, then, when the guard 32 moves to the closed position, the spring 66 makes contact with the backrest 67 and keeps this guard 32 at least partially open until that it is sufficiently closed to engage the pawls 54 in the slots 58, to lock the guard on the assembly. When the guard 32 is locked, the closing action exceeds the resistance provided by the coupling of the backrest 67 on the spring 66 and the pawls 54 engage with the slots 58 to substantially secure in an irreversible way the guard 32 to the assembly. This guard 32 preferably includes a flange 68, which is positioned proximally on the outer surface 41 of the guard, to assist the practitioner in moving the guard from the open position to the closed or locked position. The assembly 10 also preferably includes at least one detent in the form of a protrusion, preferably two protuberances 83, to keep the guard partially open. The protuberances 83 are disposed on the outward projection 56 and with a dimension to freely interfere with at least one arm 60 to provide resistance to the pivoting movement of the guard 32. The resistance to pivoting movement tends to keep the guard in position until be intentionally moved by the professional. Preferably, the assembly can rotate around the center 20 of the needle. This rotation is best seen in Figures 17, 18 and 20. The opening 49 in the assembly 48 preferably includes an annular groove 78 on an inner surface 79, which is of such size and arranged to engage a projection 21 on an outer surface. 23 of the center 20 of the needle, when the portion 53 of the center of the needle is placed in the opening 49. The coupling of the groove 78 and the projection 21 retains the assembly on the center and allows rotation of the assembly around the center. Preferably, the slot 78 includes a stop 79, which is positioned to engage the projection 21 and limit the rotation of the assembly 48 about the center 20 to less than about one rotation. The limit of the rotation of the assembly around the center facilitates the screwing and unscrewing to mount and disassemble the center of the needle on a fluid handling device. The preferred rotational ability of the assembly around the center of the needle allows the practitioner to position the guard 32 with respect to a bevel 19 of the acute distal tip 17 of the needle. The ability to position the guard 32 with respect to the bevel 19 of the needle is particularly important in procedures such as blood drawing and the like, where the position of the needle bevel is important for the success of the procedure. Since, preferably, the guard 32 can be rotatably placed around the center, like open and closed pivotalamente, the guard 32 can be moved to allow professionals to place the guard according to their needs. If the assembly 48 can not rotate around the center and the placement of the bevel 19 of the needle is critical, further restriction of the orientation of the bevel of the needle in the manufacturing process is imposed. Alternatively, for applications where the placement of the needle bevel is not critical in the procedure, the assembly 48 can be fixedly attached to the center 20. Referring to Figure 21, the center 20 can be fixedly attached within the opening 49 in assembly 48 by techniques including, but not limited to, an adhesive bond; a mechanical interference fit between the center of the needle and the opening, a solvent bond between the center of the needle and the opening, a thermal seal between the center of the needle and the opening; an ultrasonic weld between the center of the needle and the opening and a mechanical snap fit between the center of the needle and the opening. A further alternative is illustrated in Figure 22, where all elements of the center 48 and center 20 of the needle are integrally formed in a unitary structure 80. Another alternative embodiment, which is particularly directed towards phlebotomy, is shown in the Figure 23. In this embodiment, there are elements similar in structure and function to the embodiment of the present invention, shown in Figures 1 to 20. Therefore, substantially similar components, which perform substantially similar functions, have identical numbering to the components of the embodiment of Figures 1 to 20, except that a suffix "a" is added to identify those components in Figure 23. The assembly 10a includes the guard 32a and the assembly 48a. In this embodiment, the needle 12a has a proximal portion 11 with an acute distal tip 17a and a flow control valve 15 to occlude the flow through the needle. The assembly 10a also has the needle 12a disposed in the axial bore 28a in the center 20a, so that both the acute proximal tip 13 and the acute distal tip 17a project from the center. The center 20a of the needle includes external distal threads 25 for mounting the center 20a on a needle holder 90. This needle holder 90 is useful for filling evacuated blood collection tubes, which are mounted on the needle holder 90 and on the distal portion 11 of the flow control valve 15 that moves the needle. The guard, assembly and needle center of the invention can be formed of polymeric materials, such as thermoplastic resins, molded resins and the like. Suitable thermoplastic resins include, but are not limited to, polypropylene, polyethylene, acrylonitrile-butadiene-styrene, polycarbonate, polystyrene, and the like. Polypropylene and polyethylene are preferred as thermoplastic resins, when injection molding is selected as the forming technique. For some applications, polycarbonate resin may be preferred for applications where transparency and rigidity are required. The needles suitable for use in the assembly may be stainless steel. In the assembly 10, the needle 12 is fixedly attached to the center 20. Suitable methods for firmly attaching the needle to the center include, but are not limited to, bonding by adhesive and inserting the needle into the center. Preferably, the needle 12 is bonded by adhesive at the center 20. Referring again to Figure 2, the assembly 10 can be placed in a fluid handling device, such as the syringe 30 and sealed in a pack 92 formed of materials substantially resistant to the passage of microorganisms. The package can then be exposed to conditions that make any microorganism in the package unfeasible. The assembly 10 is then considered sterile until the package 92 is opened. Suitable materials for forming the package 92 include, but are not limited to, paper, thermoplastic films, spin-bonded non-woven polyolefins and the like. Suitable conditions for rendering microorganisms non-viable include, but are not limited to, exposure to chemical sterilants, such as ethylene oxide, gaseous hydrogen peroxide and the like, and exposure to ionizing radiation, such as gamma radiation and Beta radiation The selection of packaging materials and materials for the formation of the assembly, must take into account the expected sterilization. The protected needle assembly of the invention is simple to manufacture and easy to use. The set allows professionals to intuitively discover the needle for use by removing the cover, then return to the needles and lock the mounting bracket substantially without placing your hands in close proximity to, or beyond, the distal point of the needle, thus encouraging professionals to protect the needle after use. In clinical settings, where sharp needles are routinely used, the use of protected assemblies of the invention can provide reductions in needling exposures without protecting both needle-wearing professionals and support personnel who may unexpectedly encounter needles. used.