Abstract:
A cap or sheath locks onto the needle or other sharp, thus permanently inactivating the needle or other sharp, preventing any further use of the device, and permanently isolating the contaminated sharp. Four components are a needle or sharp to accommodate a locking collar, a sheath with a external, internal, or horizontal track to accommodate a locking collar, a locking collar that moves inferiorly within or outside the sheath, or horizontally that binds to the sheath or needle, permanently locking the needle in the sheath and mechanically preventing the needle from moving from the sheath, and a locking mechanisms for these devices. Handles are advantageously provided for the sheath to permit safe recapping or resheathing so that the needle can be bound in the sheath and inactivated.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS  
       [0001]     This application claims priority benefit under 35 U.S.C. § 119(e) of provisional application No. 60/578,998, filed Jun. 12, 2004. The 60/578,998 application is incorporated by reference herein, in its entirety, for all purposes. 
     
    
     FIELD OF THE INVENTION  
       [0002]     The present invention relates generally to the field of sharp medical devices. More specifically, the present invention relates to the placement of protective covers of the sharp portions of a medical device so as to prevent inadvertent sticks.  
       BACKGROUND OF THE INVENTION  
       [0003]     Accidental penetration of the skin from sharp instruments is one of the most common modes of transmission of fatal or debilitating infectious diseases to health care workers. Hepatitis B, hepatitis C, and HIV (the AIDS virus) in the health care environment are typically transmitted from needle sticks and result in years of debilitating illness, loss of productivity, worker&#39;s compensation payments, medical expenses, and accelerated mortality. Health care workers most susceptible to needle sticks include nurses and laboratory workers, but physicians, dentists, dialysis workers, oral surgeons, medical waste workers, and animal handlers are also exposed.  
         [0004]     Using a standard cap, recapping a hypodermic needle is an extremely dangerous procedure, entailing a 6% risk of needle stick of per capping attempt. OSHA requires regular instruction of health care workers in techniques to prevent accidental needle sticks, yet needle sticks, especially those from recapping, remain an important mechanism for transmission of virulent infectious agents to health care workers. Any advances in medical instrument design that would limit or prevent needle sticks would markedly reduce the health risks from infectious diseases for health care workers and would result in considerable savings from lost productivity, medical costs, litigation, and compensation payments. Most importantly, the health and safety of health care workers would be improved.  
         [0005]     Hypodermic needles have been used for many years in industry, research, and medical practice. These needles, which consist of a hollow metal tube sharpened on one end in order to penetrate the skin or other substance, are attached to a syringe which is used to aspirate or inject volumes of fluid through the hollow barrel of the needle. In medical practice, hypodermic needles are most often used to inject medications into skin, subcutaneous tissues, muscle, blood vessels, or other tissues. Hypodermic needles are also used to aspirate fluid from body cavities and to transfer medications, samples, or reagents from stoppered bottles or other containers to other containers or devices.  
         [0006]     Before use, the hypodermic needle is sharp but sterile. However, after use, the needle becomes contaminated with blood, body fluids, or residual fluid remaining from aspiration of samples from bottles. These contaminated hypodermic needles remain very sharp and easily penetrate the skin, directly depositing infectious agents into the body tissues of the medical worker. These injuries have a high incidence of transmission of hepatitis B and hepatitis C, as well as other infectious agents. Needle sticks from hypodermic needles occur in several ways: 1) accidental sticks that occur from improperly discarded uncapped needles or capped needles that become uncapped in refuse or by impact, 2) accidental sticks that occur from the act of improperly discarding needles, 3) sticks that occur from attempts to recap the contaminated needle, 4) sticks that occur to the operator from an uncapped needle not in immediate use, but still on the equipment tray or in the operating field, 5) sticks that occur in the operating field from a misdirected needle, or 6) intentional sticks.  
         [0007]     One approach to this problem has been the use of syringes with retractable needles, where as the syringe and the needle are inactivated by retracting the needle within the syringe. Although this type of retractable needle is acceptable for a simple maneuver where a medication is aspirated into a syringe from a vial then injected into a patient or medical solution, there are serious disadvantages. First, the needle becomes dull after pushing through a stopper, and then causes increased pain for the patient because of the dull needle tugs and stimulates the nerves of the skin. Moreover, certain needle designs core the stopper, resulting in a piece of rubber being injected into the patient. Also, medication or bacteria may contaminate the outside of the needle barrel, causing misadministration of medication into the skin or subcutaneous tissues or the appearance of an infection.  
         [0008]     Because of the above problems, medical workers like to change to a fresh needle before injecting a medication. Most syringes with retractable needles do not permit this. Another problem with syringes with retractable needles is that they need to be recapped if the medication is not going to be immediately administered. Thus, there is danger of a needle stick on recapping. Finally, for medical procedures, different sizes of needles need to be used for different components of the procedure, thus, needles are often changed on syringes. Furthermore, aspirated fluid often needs to be kept in a syringe for analysis, but the needle cannot be inactivated in most retractable syringes without isolating the aspirated fluid.  
         [0009]     Safety needles have also been proposed, where the needle has an attached sheath that is slid over or otherwise covers the needle after use. Although these types of needles may permit needles to be inactivated and changed between different components of a medical procedure and obviates recapping to inactivate, often they have to be recapped anyway for transport before use. Another major problem with these types of safety needles are that the safety mechanism increases the physical profile of the needle, resulting in a physical obstruction during a medical procedure and thus decreased line of sight and on occasion, an actually physical obstruction of the safety device interfering with the medical procedure. In addition, many of these safety needles, depending on the design, will fit on only one size of syringe so many duplicative needles are required for different syringe sizes.  
         [0010]     Because of these features, nurses, physicians, and other medical workers generally do not like syringes with retractable needles and similarly are dissatisfied with most safety needles for administering medications or performing syringe procedures.  
         [0011]     What is needed is both a mechanism to safety recap needles and sharp, to changes needles as desired and appropriate, to provide a low profile needle that permits exact control by the operator, and to provide a locking sheath that permanently inactivate a needle it so that needle sticks cannot occur and contaminated or noxious contents are isolated within the needle.  
       SUMMARY OF THE INVENTION  
       [0012]     The present invention overcomes all the above-noted difficulties of the other approaches to this problem. The present invention has of a cap or sheath which locks onto the needle or other sharp, thus permanently inactivating the needle or other sharp, preventing any further use of the device, and permanently isolating the contaminated sharp.  
         [0013]     One aspect of the invention is a needle or sharp to accommodating a locking collar or collar equivalent.  
         [0014]     Another aspect of the invention is a sheath with a track (external, internal, or horizontal) to accommodate a locking collar or collar equivalent.  
         [0015]     Yet another aspect of the invention is a locking collar or equivalent that moves inferiorly within or outside the sheath, or horizontally that binds to the sheath or needle, permanently locking the needle or sharp in the sheath and mechanically preventing the needle from moving from the sheath.  
         [0016]     Still another aspect of the invention is a locking mechanisms for such devices.  
         [0017]     Another aspect of the invention is to provide one or more handles for the sheath to permit safe recapping or re-sheathing so that the needle can be bound in the sheath and inactivated. 
     
    
     BRIEF DESCRIPTION OF THE FIGURES  
       [0018]      FIG. 1  illustrates a needle with a protective sheath according to one embodiment of the present invention, with a locking collar in a utility position.  
         [0019]      FIG. 2  illustrates a needle with a protective sheath according to the embodiment of  FIG. 1 , with the locking collar in a fully locked position.  
         [0020]      FIG. 3  illustrates a needle according to the embodiment of  FIG. 1 .  
         [0021]      FIG. 4  illustrates a protective sheath according to the embodiment of  FIG. 1 .  
         [0022]      FIG. 5  illustrates a front elevation view of a locking collar according to the embodiment of  FIG. 1 .  
         [0023]      FIG. 6  illustrates a side elevation view of a locking collar according to the embodiment of  FIG. 1 .  
         [0024]      FIG. 7  illustrates a bottom plan view of a locking collar according to the embodiment of  FIG. 1 .  
         [0025]      FIG. 8  illustrates a sectional view of a locking collar according to the embodiment of  FIG. 1 .  
         [0026]      FIG. 9  illustrates a front elevation view of a locking collar according to an alternate embodiment.  
         [0027]      FIG. 10  illustrates a side elevation view of a locking collar according to the alternate embodiment of  FIG. 9 .  
         [0028]      FIG. 11  illustrates a bottom plan view of a locking collar according to the alternate embodiment of  FIG. 9 .  
         [0029]      FIG. 12  illustrates a sectional view of a locking collar according to the alternate embodiment of  FIG. 9 .  
         [0030]      FIG. 13  illustrates a needle with a protective sheath according to another embodiment of the present invention, with an internal locking collar in a utility position.  
         [0031]      FIG. 14  illustrates a needle with a protective sheath according to the embodiment of  FIG. 13 , with the internal locking collar in a fully locked position.  
         [0032]      FIG. 15  illustrates an elevation view of the needle according to the embodiment of  FIG. 13 .  
         [0033]      FIG. 16  illustrates an elevation view of the protective sheath according to the embodiment of  FIG. 13 .  
         [0034]      FIG. 17  illustrates an elevation view of the internal locking collar according to the embodiment of  FIG. 13 .  
         [0035]      FIG. 18  illustrates a section view of the internal locking collar according to the embodiment of  FIG. 13 .  
         [0036]      FIG. 19  illustrates a bottom plan view of the internal locking collar according to the embodiment of  FIG. 13 .  
         [0037]      FIG. 20  illustrates a needle with a protective sheath according to yet another embodiment of the present invention, with a lateral locking collar in a utility position.  
         [0038]      FIG. 21  illustrates a needle with a protective sheath according to the embodiment of  FIG. 20 , with the lateral locking collar in a fully locked position.  
         [0039]      FIG. 22  illustrates an elevation view of the needle according to the embodiment of  FIG. 20 .  
         [0040]      FIG. 23  illustrates a side elevation view of the protective sheath according to the embodiment of  FIG. 20 .  
         [0041]      FIG. 24  illustrates a front elevation view of the protective sheath according to the embodiment of  FIG. 20 .  
         [0042]      FIG. 25  illustrates an elevation view of the lateral locking collar according to the embodiment of  FIG. 20 .  
         [0043]      FIG. 26  illustrates a plan view of the lateral locking collar according to the embodiment of  FIG. 20 .  
         [0044]      FIG. 27  illustrates a plan view of the lateral locking collar according to an alternate embodiment of  FIG. 20 .  
         [0045]      FIG. 28  illustrates an embodiment of the invention similar to that shown in  FIG. 1 , including the additional feature of a handle.  
         [0046]      FIG. 29  illustrates an embodiment of the invention similar to that shown in  FIG. 13 , including the additional feature of a handle.  
         [0047]      FIG. 30  illustrates an embodiment of the invention similar to that shown in  FIG. 20 , including the additional feature of a handle.  
         [0048]      FIG. 31  illustrates a detail view of the protective cap similar to that shown in the embodiment of  FIG. 29 , showing dimensioning of the handle.  
         [0049]      FIG. 32  illustrates a detail view of the protective cap similar to that shown in the embodiment of  FIG. 29 , showing an alternate handle shape.  
         [0050]      FIG. 33  illustrates a detail view of the protective cap similar to that shown in the embodiment of  FIG. 29 , showing an additional handle connected to the internal locking collar. 
     
    
     DETAILED DESCRIPTION  
       [0051]      FIGS. 1-12  illustrate a safety needle with an external locking mechanism.  
         [0052]     Referring to  FIG. 1 , a needle with a protective sheath according to one embodiment of the present invention is illustrated, with a locking collar in a utility position. This embodiment has a safety needle with an external locking collar disposed outside of the sheath.  
         [0053]     Referring to  FIG. 2 , a needle with a protective sheath according to the embodiment of  FIG. 1  is illustrated, with the locking collar in a fully locked position. Locking fittings on the end of the collar interdigitate and lock into the corresponding fittings on the needle neck.  
         [0054]     Referring to  FIG. 3 , a needle according to the embodiment of  FIG. 1  is illustrated. The needle  10  has a metal barrel  20 , a hub  30 , a neck  40 , and a fitting  50 , such as a Luer. The enlarged neck  40  can function as a grip and can be textured as shown, or can not be a grip, and can be non-textured and smaller than shown, but generally will be equal or greater in diameter to the outside diameter of the cap or sheath. The outside surface of the neck can be parallel to the axis of the metal barrel of the needle, or can have an angle to the surface (as shown) to facilitate movement of the locking device over the neck. The locking surface on the neck can be anywhere on the neck. However, the locking surface on the neck typically could be the fitting (inferior) side as shown, on the grip side (lateral side), or on the surface adjoining the hub (superior side), with the only requirement that there be a fitting to interdigitate and receive the corresponding fitting of the locking collar. In the case of a screw fitting, this surface would include a-threaded fitting which would interdigitate with a corresponding fitting on the collar. This could be reversible, locking or “child-proof” threads.  
         [0055]     Referring to  FIG. 4 , a protective sheath according to the embodiment of  FIG. 1  is illustrated. The hollow cap or sheath  60  is usually a cylinder composed of plastic which is closed at one end and open at the other end to accommodate the needle. This cap can be a wrench cap (with fittings that mesh with the needle hub used to seat the needle fitting into a medical device) or a non-wrench cap (used to cover the device only), The sides  70  of the sheath  60  can be parallel to the needle barrel as shown, or can be angled in any direction. In a number of situations it will be valuable to have stops  80 ,  90  to limit careless or accidental movement of the locking collar on the sheath, particularly when the needle is being seated on a medical device, being uncapped or recapped, or otherwise being moved about or manipulated. These stops  80 ,  90  can be permanent or can be overcome with force, and thus can be on the same side of the collar when locked (as shown in  FIG. 2 ) or can be on opposite sides of the collar when locked. A permanent stop  100  is used to mechanically bind the collar to both the sheath  60  and the needle  10  when in the locked position.  
         [0056]     According to alternate configurations (not shown), a stop  90  could function as the permanent stop. With or without the stops, the collar could also be limited in motion by having a metal or plastic spring, or compressible foam which would be placed on the cap  60 , would be limited in its motion by the permanent stop  100 , and then the collar would be placed on top spring so that the spring would reside between the locking collar and the permanent stop  100 . This would be another method other than the stop  90  to prevent unwanted movement of the locking collar down upon the neck of the needle.  
         [0057]     Two examples are shown of locking collars that slide in a longitudinal direction on the cap or sheath, locking the needle into the cap.  FIGS. 5-8  illustrate an example with two or more tines or arms that lock the cap or sheath onto the needle neck.  FIGS. 9-12  illustrate an example with a locking collar that is a continuous cylindrical piece without arms or tines.  
         [0058]     Referring to  FIG. 5 , a front elevation view of a locking collar according to the embodiment of  FIG. 1  is illustrated. The locking collar has a circular or band-like fitting  120  that is generally continuous which creates the aperture or hole that accommodates the cap or sheath. Tines or arms  130 , which are attached to the circular fitting  120 , have a locking fitting  140 .  
         [0059]     Referring to  FIG. 6 , a side elevation view of a locking collar according to the embodiment of  FIG. 1  is illustrated. The circular fitting  120  and a tine  130  are shown.  
         [0060]     Referring to  FIG. 7 , a bottom plan view of a locking collar according to the embodiment of  FIG. 1  is illustrated. A circular or band-like fitting  120 , which is generally continuous, creates the aperture or hole  110  that accommodates the cap or sheath. Tines or arms  130  are attached to the circular fitting  120 . Locking fittings  140  on the ends of the tines  130  interdigitate with and lock into the corresponding fittings on the needle neck.  
         [0061]     Referring to  FIG. 8 , a sectional view of a locking collar according to the embodiment of  FIG. 1  is illustrated. An aperture or hole  110  that accommodates the cap or sheath and is formed by a circular or band-like fitting which is generally continuous. This fitting need not be circular however, and could accommodate other geometric shapes (rectangular, grooves, ovals, etc) as long as they correspond to the external surface of sheath or cap so that the collar can move in a longitudinal direction (long dimension of the cap). Tines or arms  130  are attached to the circular fitting that have a locking fitting  140  that locks into the corresponding fitting of the needle neck. In this case, engagement of the locking fitting  140  is on the fitting side (inferior) of neck, but could on the grip side (lateral), or the hub side (superior). Two tines  130  are illustrated, but a larger number is also possible.  
         [0062]     Referring to  FIG. 9 , a front elevation view of a locking collar according to an alternate embodiment is illustrated. An aperture or hole  160  is sized to accommodate the cap or sheath. The external sides  170  of the continuous circular fitting and these sides that have a locking fitting  180  on the end. These locking fitting s  180  are internal if the collar is locking to the base of the neck and sides of the needle neck, but could be internal or external if they lock into the top of the needle neck.  
         [0063]     Referring to  FIG. 10 , a side elevation view of a locking collar according to the alternate embodiment of  FIG. 9  is illustrated. The circular hole  160  accommodates the cap. The sides  170  of the collar are shown.  
         [0064]     Referring to  FIG. 11 , a bottom plan view of a locking collar according to the alternate embodiment of  FIG. 9  is illustrated. The roof  160  of the collar is generally continuous so as to create the aperture or hole  150  that accommodates the cap or sheath. The external side surfaces  170  of the collar are connected at the bottom with locking fittings  180 .  
         [0065]     Referring to  FIG. 12 , a sectional view of a locking collar according to the alternate embodiment of  FIG. 9  is illustrated. An aperture or hole  150  that accommodates the cap or sheath and is formed by the roof of the fitting and is generally continuous. This fitting need not be circular however, and could accommodate other geometric shapes (rectangular, grooves, ovals, etc) as long as they correspond to the external surface of sheath or cap so that the collar can move in a longitudinal direction (long dimension of the cap). The internal sides  170  of the continuous locking collar terminate at the end of the cylinder as a locking fitting  180  that locks into the corresponding fitting of the needle neck. In the illustrated case the needle neck is on the fitting side of the neck, but could on the grip side (lateral), or the hub side (superior). This locking fitting  180  can be continuous or intermittent, but if intermittent at least 2 are needed for a very firm locking device. Although one could also suffice, such a configuration would not provide optimal locking stability.  
         [0066]     It is anticipated that the external locking collar, which in the in the above discussion uses the cap or sheath itself for a track to control the motion of the collar, could instead use linear longitudinal tracks on sheath which would interdigitate with corresponding components on the collar or collar equivalent. Also, in the present instance it is shown that the male component or the locking mechanism is on the collar which fits over the female component of the locking mechanism on the needle base, hub, or neck. However, this could be reversed, where the male component would instead be on the needle base, hub, or neck and would lock over the female component of the collar or collar equivalent.  
         [0067]     Examples of locking devices that would function with these designs includes tapered and/or interlocking rings or tabs; oppositely directed and interlocking dentates or projections whether abrupt or tapered; interlocking rings, ridges, or shaped projections that are trapped in a space created by a tapered dentate or projection and a mating surface that accommodates this projection, or oppositely directed dentates or projections; locking tines with or without male and female components, screw and threaded fittings including standard, incomplete, and “child proof.” These are only examples, and many other locking mechanisms are possible and anticipated between the outer collar or collar equivalent and the base, hub, or neck of the needle.  
         [0068]     Referring to  FIGS. 13-19 , a safety needle is illustrated with an internal locking collar inside the sheath or cap.  
         [0069]     Referring to  FIG. 13 , a needle with a protective sheath according to another embodiment of the present invention is illustrated, with an internal locking collar in a position that permits the needle to be uncapped and used.  
         [0070]     Referring to  FIG. 14 , a needle with a protective sheath according to the embodiment of  FIG. 13  is illustrated, with the internal locking collar in a fully locked position.  
         [0071]     Referring to  FIG. 15 , an elevation view of the needle according to the embodiment of  FIG. 13  is illustrated. The needle  200  has a metal barrel  210 , a hub  220 , a neck  230 , and a fitting  240 , such as a Luer. The neck  230  can function as a grip and can be textured, or can not be a grip, and can be non-textured and smaller than shown, but generally will contact the outside cap or sheath. The outside surface of the neck can be parallel to the axis of the metal barrel of the needle, or can have an angle or fittings so that the cap can be used as a wrench. The locking surface can be on the hub or neck here it is shown on the hub  220 . On the hub  220 , the locking surface can be can be anywhere, however, the locking surface on the neck on the surface adjoining the hub (superior side) with the only requirement that there be a fitting to interdigitate and receive the corresponding fitting of the locking collar. In the case of a screw fitting, this surface would include a threaded fitting which would interdigitate with a corresponding fitting on the collar. This could be reversible, locking or “child-proof” threads.  
         [0072]     Referring to  FIG. 16 , an elevation view of the protective sheath according to the embodiment of  FIG. 13  is illustrated. The hollow cap or sheath  250  is usually a cylinder composed of plastic which is open at both ends to accommodate internally both the needle and the locking collar. This cap can be a wrench cap (with fittings that mesh with the needle hub used to seat the needle fitting into a medical device) or a non-wrench cap (used to cover the device only). The opening on the superior end  300  accommodates the internal locking collar. The sides  260  of the sheath can be parallel to the needle barrel as shown, or can be angled in any direction. In a number of situations it will be valuable to have stops  270 ,  280  to limit careless or accidental movement of the locking collar within the sheath or cap, particularly when the needle is being seated on a medical device, being uncapped or recapped, or otherwise being moved about or manipulated. These stops  270 ,  280  can be permanent or can be overcome with force (as shown), and thus can be on the same side of the collar when locked (as shown) or can be on opposite sides of the collar when locked. Finally, the inferior surface of the cap or sheath  290  is necessary to mechanically bind the collar to both the sheath and the needle when in the locked position. With certain designs a stop  280  could function as the permanent stop. With or without the stops, the collar could also be limited in motion by having a metal or plastic spring, or compressible foam which would be placed within the cap  250 , would be limited in its motion by the stops  270 ,  280 ,  290 , and then the collar would be placed either on top of the spring or within the spring so that the spring would reside between the locking collar and the stops  270 ,  280 ,  290 . This would be another method other than the stop  280  to prevent unwanted movement of the locking collar down upon the needle.  
         [0073]      FIGS. 17 and 18  illustrate an example of an internal locking collar which would slide in a longitudinal direction within the cap or sheath, and bind to the needle hub or neck locking the needle into the cap. This exemplary embodiment has a locking collar that is a continuous cylindrical piece, although other shapes including an incomplete cylinder with arms or tines and locking mechanisms are contemplated.  
         [0074]     Referring to  FIG. 17 , an elevation view of the internal locking collar according to the embodiment of  FIG. 13  is illustrated. A stop  340  is disposed on the external sides  320  of the internal locking collar and these sides  320  have a locking fitting  330  on the end. These are internal if the collar is locking to the base of the neck and sides of the needle neck, but could be internal or external if they lock into the top of the needle neck. An inferior stop  350  is configured to mesh with the stops  270 ,  280  of the collar.  
         [0075]     Referring to  FIG. 18 , a section view of the internal locking collar according to the embodiment of  FIG. 13  is illustrated. An inner surface  310  of the collar is shown. This fitting need not be circular however, and could accommodate other geometric shapes (rectangular, grooves, ovals, etc) as long as they correspond to the external surface of sheath or cap so that the collar can move in a longitudinal direction (long dimension of the cap). The external sides  320  of the internal locking collar and at the end of the cylinder is a locking fitting  330  that locks into the corresponding fitting of the needle hub or neck, which in this case is on the hub  220 . These locking fittings can be continuous or intermittent, but if intermittent at least 2 are useful to provide a very firm locking device. Although one could also suffice, is not optimal for locking stability. A stop  340  mechanically binds the inner locking collar to the cap or sheath. This could abut the end of the cap as shown, or could interdigitate with an internal stop in the cap (not shown). An inferior stop  350  is configured to mesh with the stops  270 ,  280  of the collar  250 .  
         [0076]     Referring to  FIG. 19 , a bottom plan view of the internal locking collar according to the embodiment of  FIG. 13  is illustrated. The internal surface of the collar with the locking mechanisms  310  is shown. The roof  360  of the collar is generally continuous and also functions as the roof of the cap or sheath. The external side  320  surfaces of the collar come down to the end  330  of the collar that presents the locking fittings  310  on the end of the collar which interdigitate and lock into he corresponding fittings on the needle neck.  
         [0077]     As in the first embodiment, the internal external locking collar, which in the above examples uses the cap or sheath itself for a tract to control the motion of the collar, could instead use linear longitudinal tracks within the sheath which would interdigitate with corresponding components on the collar or collar equivalent. Also, in the present instance it is shown that the male component or the locking mechanism is on the collar which fits over the female component of the locking mechanism on the needle base, hub, or neck; however, this could be reversed, where the male component would instead be on the needle base, hub, or neck and would lock over the female component of the collar or collar equivalent  
         [0078]     Also, as in the first embodiment, examples of locking devices that would function with these designs includes tapered and/or interlocking rings or tabs; oppositely directed and interlocking dentates or projections whether abrupt or tapered; interlocking rings, ridges, or shaped projections that are crapped in a space created by a tapered dentate or projection and a mating surface that accommodates this projection, or oppositely directed dentates or projections; locking tines with or without male and female components, screw and threaded fittings including standard, incomplete, and “child proof.” These are only examples, and many other locking mechanisms are possible and anticipated between the inner collar or collar equivalent and the base, hub, or neck of the needle.  
         [0079]     Although the previous two described embodiments effectively lock the cap or sheath to the needle or other sharp device, they are limited by the fact that to lock the cap to the needle, the needle must be seated in a rigid medical device or the needle hub or butt placed on a rigid surface so that the force placed on the collar causes locking rather than pushing the needle out of the cap or sheath. If collar is depressed rapidly while the needle is with the sheath, but not seated in a rigid device or placed against a hard surface, the needle may actually be dangerously ejected. Thus, there are limitation to these types of safety needles.  
         [0080]     What is needed is a locking collar that locks the needle within the sheath or cap while the needle is seated on a device or when the needle is free, where putting against a hard surface is not necessary. A safety needle with a lateral locking collar accomplishes all of these goals.  FIGS. 20-27  illustrate such an embodiment of the present invention.  
         [0081]     Referring to  FIG. 20 , a needle with a protective sheath according to yet another embodiment of the present invention is illustrated, with a lateral locking collar in a position that permits uncapping and use of the needle.  
         [0082]     Referring to  FIG. 21 , a needle with a protective sheath according to the embodiment of  FIG. 20  is illustrated, with the lateral locking collar in a fully locked position.  
         [0083]     Referring to  FIG. 22 , an elevation view of the needle according to the embodiment of  FIG. 20  is illustrated. The needle  400  has a metal barrel  410 , a hub  420 , a neck  430 , and a fitting  440 , such as a Luer fitting. The neck  430  can function as a grip and can be textured, or can not be a grip, and can be non-textured and smaller than shown, but generally will contact the outside cap or sheath. The outside surface of the neck can be parallel to the axis of the metal barrel of the needle, or can have an angle or fittings so that the cap can be used as a wrench. The locking surface can be on the hub  420  or neck  430  and can be a single area of different diameter or multiple areas, creating a “notch” for a locking device. The locking device can be on the needle hub or the cap or both. Here it is shown on the cap  490 . The hub or neck are important for providing a surface and plane for the needle to be locked into the cap or sheath.  
         [0084]     Referring to  FIG. 23 , a side elevation view of the protective sheath according to the embodiment of  FIG. 20  is illustrated. Referring to  FIG. 24 , a front elevation view of the protective sheath according to the embodiment of  FIG. 20  is illustrated. The hollow cap or sheath is usually a cylinder composed of plastic which is open at both ends to accommodate internally both the needle and the locking collar. Here is shown in a lateral section and a partial frontal view. This cap can be a wrench cap (with fittings that mesh with the needle hub used to seat the needle fitting into a medical device) or a non-wrench cap (used to cover the device only}. The sides of the sheath  450  can be parallel to the needle barrel as shown, or can be angled in any direction. The surface  460  that contacts the needle hub or neck and this contact point can be external or internal to the cap and sheath, and can have interdigitating features so that it acts as a “wrench” on the needle hub or neck. An extension  470  of the cap that holds a track  480  so that the lateral locking collar can move in this track. Here the track  480  is shown to be internal, but this could be made on the external surface with appropriate grooved joints that permit linear motion of the collar in the track. This track  480  is shown on the extension  470  of the cap, but the track could be in the cap itself, and could use the hub  420  rather than the neck  430  to lock the needle into the cap. Also, to prevent careless locking of the cap, a guard could protrude from the extension  470  either superior or inferior to limit careless or accidental movement of the locking collar within the sheath or cap, particularly when the needle is being seated on a medical device, being uncapped or recapped, or otherwise being moved about or manipulated. Also a temporary or permanent stop  490  can be integrated in the track  480  which would interdigitate with a temporary stop on the locking collar.  
         [0085]     These stops are can be permanent or can be overcome with force, and thus can be on the same side of the collar when locked (as shown) or can be on opposite sides of the collar when locked. With certain designs the stop  490  could function as this permanent stop. With or without the stops, the collar could also be limited in motion by having a metal or plastic spring, or compressible foam which would be placed within or outside the track  480 , would be limited in its motion by the stops, and then the collar would be placed either on top of the spring or within the spring so that the spring would reside between the locking collar and the stops. This would be another method other than the stop  490  to prevent unwanted movement of the locking collar down upon the needle.  
         [0086]      FIGS. 25-27  show examples of an lateral locking collar which would slide in a lateral (horizontal) direction into the cap or sheath, and bind to the needle hub or neck locking the needle into the cap. These figures illustrate the example of a lateral locking collar that is a continuous generally rectangular piece with a half circle as the portion that interdigitates with the needle, although other shapes including a full circle, arms or tines or other projections and locking mechanisms are anticipated and claimed.  
         [0087]     Referring to  FIG. 25 , an elevation view of the lateral locking collar according to the embodiment of  FIG. 20  is illustrated. The body  500  of the collar is shown. In this case, the body  500  is generally has a smooth or planar surface to move with the track  480 ; however, the surface in contact with the track  480  need not be strictly planar and could have a complex surface consisting of curved grooves which mates with corresponding grooves on the cap or sheath or on the cap extensions  470  providing a track to move in a linear lateral direction, providing the same mating function. These tracks could be internal, or external on the sides, top, or bottom of the sheath. The body  500  can have other geometric shapes (rectangular, columnar, etc) as long as these shapes correspond shape of the track  480  of sheath or cap so that the collar can move in a lateral (horizontal) direction (short dimension of the cap). The permanent locking mechanism of the lateral locking collar, here consists of a dentate  510  which locks into a corresponding receptacle  490  in the track  480 . However, many other locking mechanisms besides dentates-in-hole (opposing dentates, ridge-in-furrow, peg-in-hole, slot and notch, and others) are possible and anticipated. The locking mechanism need not be in the tract, but could also be on the needle hub or neck, or could be on the opposing side of the cap or sheath. These locking fittings can be continuous or intermittent, although one, as shown, could also suffice. A temporary stop  520  is shown that temporarily restricts the motion of the locking collar so that it does not move unintentionally during manipulations. This temporary stop can be overcome with force.  
         [0088]     Referring to  FIG. 26 , a plan view of the lateral locking collar according to the embodiment of  FIG. 20  is illustrated. The superior surface  530  of the lateral locking collar is shown. The permanent or temporary locking device  510 , a dentate in this case. The temporary stop  520  is shown. The half parabolic or oval cutaway  540  is the surface of the lateral locking collar that mates with the needle neck or hub, and restricts the motion of the needle by providing a mechanical obstruction to neck  430  or hub  420  by binding its inferior surface, so the needle or sharp cannot be removed from the cap or sheath. As mentioned the surfaces  430 ,  420  or other surfaces on the needle base, could have corresponding locking surfaces to the locking collar. This cutaway section  540  need not be “U-shaped” as shown, but have other shapes (open rectangular, notched (being the locking surface itself), or even circular, elliptical, or eccentric, where it could be a moveable part of the cap or sheath).  
         [0089]     Referring to  FIG. 27 , a plan view of the lateral locking collar according to an alternate embodiment of  FIG. 20  is illustrated. This is accomplished by having the binding surface of the sliding collar  542  having a narrow deformable opening which when force is put on the lateral sliding collar deforms around the hub or base and then locks the needle in the larger space. This can be used in association with other locking mechanisms is the internal surface of the collar with the locking mechanisms.  
         [0090]     Also, as in the first embodiment, examples of locking devices that would function with these designs includes tapered and/or interlocking rings or tabs; oppositely directed and interlocking dentates or projections whether abrupt or tapered; interlocking rings, ridges, or shaped projections that are trapped in a space created by a tapered dentate or projection and a mating surface that accommodates ties projection, or oppositely directed dentates or projections; locking tines with or without male and female components, screw and threaded fittings including standard, incomplete, and “child proof.” These are only examples, and many other locking mechanisms are possible and anticipated between the lateral collar or collar equivalent and the base; hub, or neck of the needle or the extension of the sheath or cap.  
         [0091]     One of the aspects of this safety needle system, is that the needle be recapped after use in order to lack it within the sheath using the safety collar. Recapping or resheathing a sharp is one of the most dangerous procedures for medical personnel, and results in a high proportion of the needle sticks to medical workers. However, experiments in our laboratory have demonstrated that sheaths with handles reduce recapping or resheath sticks from about 6% to less than 0.01%, a tremendous reduction.  
         [0092]     Thus, sheaths with handles would be most optimal for these devices.  FIGS. 28-33  demonstrates examples of locking sheaths with handles.  
         [0093]     Referring to  FIG. 28 , an embodiment of the invention similar to that shown in  FIG. 1  is illustrated, including the additional feature of a handle. The handle  610  for the sheath with the external locking collar is shown. Since the locking collar must move down the sheath or cap to bind the needle, the handle  610  must not impeded this longitudinal movement of the collar down the sheath. To accommodate the movement of the collar, the handle is joined to the sheath above the locking collar, and a horizontal member of the handle, provides adequate room for the sheath to move down the cap without contacting the handle  610 . Alternatively, the horizontal member section of the handle could join at the base of the cap or sheath, but in this case there would have to be a slit in the locking collar to accommodate the presence of the handle in this lower position.  
         [0094]     Referring to  FIG. 29 , an embodiment of the invention similar to that shown in  FIG. 13  is illustrated, including the additional feature of a handle. The handle  620  is shown on a sheath with an internal locking collar. In this case, the handle  620  can join anywhere on the external sheath, but not on the exterior portion of the locking collar.  
         [0095]     Referring to  FIG. 30 , an embodiment of the invention similar to that shown in  FIG. 20  is illustrated, including the additional feature of a handle. The handle  630  is shown on a sheath with a lateral locking collar. In this case, the handle  630  joins the lateral extension which accommodates the track for the locking collar.  
         [0096]     Referring to  FIG. 31 , a detail view of the protective cap similar to that shown in the embodiment of  FIG. 29  is illustrated, showing dimensioning of the handle and demonstrates the various components of the handle. To ensure that these safety needles with locking sheath are universal, that is they will fit on any medical device, the handle must be made in a way that it does not contact or obstruct various sized medical devices. One possibility is to have the handle be horizontal (right angles to the sheath). However, that does not remove the fingers from the plane or strike zone of needle sticks. One solution, is to have a lateral (horizontal) member that puts the handle away from the centerline (center of the fitting for the needle or sharp) of the medical device a specified distance shown by the dimension  640 . The inferior distance away from the needle fitting is then determined by the dimension  650  of the handle.  
         [0097]     Referring to  FIG. 32 , a detail view of the protective cap similar to that shown in the embodiment of  FIG. 29  is illustrated, showing an alternate handle shape. According to this alternate embodiment, the handle is placed at an angle like a angel winged that both puts the fingers laterally and inferiorly away from the strike zone. Either or both the horizontal member  660  and the handle  67   j   0  can be angled to accommodate medical devices that increase in size with distance from the needle fitting.  
         [0098]     Referring to  FIG. 33 , a detail view of the protective cap similar to that shown in the embodiment of  FIG. 29  is illustrated, showing an accessory handle connected to the internal locking collar. An accessory handle  680  can also bind to the collar through a slit or opening in the exterior sheath  692  so that the locking collar  690  can be mated to the needle without pushing on the top of the cap. This accessory handle  680  could be longer as well to take the fingers completely out of the strike zone for needle sticks. Similar handles may be embodied for the external and lateral locking collars as well.  
         [0099]     The present invention has been described above in terms of various exemplary embodiment. It will be understood by those of ordinary skill in the art that various modifications and improvements may be made to the described embodiments without departing from the scope of the invention. Further, any reference to claim elements in the singular, for example, using the articles “a,” “an,” or “the” is not to be construed as limiting the element to the singular.