Needlestick injury prevention device

The present invention is a device for protecting against needlestick injuries, including a syringe, a sheath, an actuator, and a button. The syringe has a tube, plunger, and a needle in a hub. The sheath covers the needle in a first position, and the needle protrudes from a hole in the sheath in a second position. The plunger can be pressed to dispense from the tube in the second position. The actuator controls the movement between positions, and the button is the manual control for activating the actuator. The syringe extends through the sheath and actuator, such that the sheath and actuator can be adjusted for any type of syringe. A single hand can operate the button and the plunger.

Not applicable.

REFERENCE TO MICROFICHE APPENDIX

Not applicable.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a safety device to reduce occupational hazards in the medical field. More particularly, the present invention relates to a device to prevent needlestick injuries, especially during surgical procedures. Even more particularly, the present invention relates to a sheath for a needle.

A needlestick injury or “needlestick” is a piercing wound from a needle point or other sharp instrument. These injuries are commonly experienced by people handling needles in the medical field. When drawing blood, administering an intramuscular or intravenous drug, or performing other procedures involving sharps, the healthcare worker can be injured with the needle slips. Generally, needlesticks cause only minor bleeding or visible trauma. Scalpel injuries tend to be larger than a needlestick. Needlestick injuries are not limited to the medical community. Any environment where sharps are encountered poses a risk, such as police work.

A needlestick injury is an occupational hazard, especially in the operating room during surgery. These injuries are important to avoid because of the risk of transmitting blood-borne diseases, such as the hepatitis B virus (HBV), the hepatitis C virus (HCV), and the Human Immunodeficiency Virus (HIV), the virus which causes AIDS. Several agencies regulate the standards and controls to reduce these occupational hazards.

There are particular concerns for needlesticks, when using the current safety devices. For example, there are already known caps and sheaths to protect healthcare workers. However, needlesticks continue to occur as a result of not recapping the needle or misjudging alignment of the needle and cap during recapping. Especially during surgery and in the operating room, surgical needles may be left uncapped and exposed for repetitive use in a procedure, increasing the risk of inadvertently penetrating the glove and skin of the surgeon or assistant.

Various patents have issued in the past relating to preventing needlestick injuries. For example, U.S. Pat. No. 6,171,284, issued to Kao, et al. on Jan. 9, 2001, describes a syringe needle cover structure comprised of a sleeve, a coil spring, and a mount. The sleeve is installed over the syringe needle, and a press release section is situated along the two exterior sides. The coil spring is installed into the center section of the sleeve, and the mount is then attached to the lower section of the said sleeve. The structure is installed over a syringe needle, wherein the user only has to pull down the protective head without removing the syringe needle cover to utilize the syringe. After use, the mount is rotated counter-clockwise to re-cover the syringe needle.

U.S. Pat. No. 7,226,431, issued to Bell-Greenstreet on Jun. 5, 2007, discloses single-use enhancements to disposable syringes. The syringe has a stem and plunger with a disk called a “spider” held near the lower end of the stem. The plunger furthermore comprises a stem extension in the shape of a short cylinder, affixed to the lower face of the spider. Finally the plunger comprises a handle affixed to the upper end of the stem. In addition, the syringe comprises a lower seal and upper seal both of cylindrical annular shape made of rubbery material. In operation, the lower seal, the plunger and the upper seal are located at the bottom of the barrel. As the syringe reaches its final state, it becomes unusable for any subsequent use because the lower seal cannot be drawn upward and the upper seal is abandoned and remains at the top of the barrel.

U.S. Pat. No. 6,783,002, issued to Pavlo on Aug. 31, 2004, teaches another anti-needlestick system. The needle has flexible wings, and a shield assembly is formed as a generally planar sheet with long side edges and short end edges and a slot for receiving the wings, when held together and adapted to be placed beneath the wings above a patient's skin. There is a male section of the shield assembly on one side of the slot, and there is a female section on the other side of the slot. Each section has an upwardly facing side wall along the side and end edges of the planar sheet. A locking member formed in the side wall includes a male locking member and a co acting female receptacle.

U.S. Pat. No. 7,513,888, issued to Sircom, et al. on Apr. 7, 2009, discloses more needle guards. Each needle guard includes a canting plate locked on the needle shaft, during retraction of the needle tip within the guard and extension of the needle tip from the guard. The plate rotates into locking engagement with the shaft of the needle, when withdrawing the need from the guard. The plate protects healthcare workers from needlesticks.

U.S. Pat. No. 7,300,421, issued to Lowry, et al. on Nov. 27, 2007, describes another safety syringe with an adapter. The invention includes adapter for a standard syringe, vacuum tube or other medical device, so that the syringe can engage a protective sheath. The sheath can be deployed automatically upon activation of a release member with a single hand in order to propel the protective sheath from a retracted position to an extended position covering a needle. An elastic member can also propel the protective sheath from a retracted to an extended position.

U.S. Pat. No. 7,159,713, issued to Austria on Jan. 9, 2007, describes a sharp blade protection device, which is related to blades and other sharps. The user inserts and removes the sharp from the device so that training of use is minimized if needed at all. The device is usable with a single hand. There is a retention post for the sharp. This device is designed to be reusable and cleanable but is capable of inexpensive manufacturing as a disposable device.

U.S. Pat. No. 6,846,302, issued to Shemesh, et al. on Jan. 25, 2005, discloses another needle protector device, comprising a protector tube slidingly disposed in an outer tube and slidingly disposed over a syringe comprising a needle. The protector tube has at least one abutment initially in engagement with the outer tube such that the protector tube is constrained from moving distally with respect to the syringe. A guide inside the outer tube provides an urging force on the protector tube in a direction that tends to urge the protector tube distally towards a tip of the needle. A release mechanism moves the abutment out of engagement with the outer tube upon distal pushing of a plunger of the syringe, such that when the at least one abutment is out of engagement with the outer tube, the guide directs the protector tube distally towards the tip of the needle.

It is an object of the present invention to provide a device to protect against needlestick injuries.

It is another object of the present invention to provide a protection device, which sheaths the needle.

It is a further object of the present invention to provide a protection device which retracts the needle.

It is another object of the present invention to provide a protection device for operation by a single hand.

It is still another object of the present invention to provide a protection device with single use and disposable options.

It is another object of the present invention to provide a device to allow reuse of solutions, anesthetics, and other chemicals.

It is another object of the present invention to provide a protection device compatible with existing syringe and needle products.

It is yet another object of the present invention to provide an easy and effective way to prevent being stuck by uncovered needles.

SUMMARY OF THE INVENTION

The present invention is a device for protecting against needlestick injuries. The device includes a syringe, a sheath, an actuator, and a button. The syringe has a tube, plunger, and a needle in a hub. The fluid for delivery is loaded into the tube. The sheath covers the needle in a first position, so that needlestick injuries are prevented. The needle protrudes from a hole in the sheath in a second position, so that the syringe can deliver the fluid to the patient. The plunger can be pressed to dispense from the tube in the second position. The actuator controls the movement between positions, such that the syringe moves within the device. The button is the manual control for activating the actuator between positions. The sheath is held in place by the hand of the user, while the thumb of the same hand engages the button. The syringe extends through the sheath and actuator, such that the sheath and actuator can be adjusted for any type of syringe. A single hand can operate the button and the plunger.

The actuator means and buttons means include various structures to control the movement of the syringe within the device. The button can be a pushbutton, a lever switch, a rod, or a rotary member. The actuator includes springs and cams to attach to the syringe and move the syringe relative to the sheath. Controlled movement by click activation of the actuator allows for safety and convenient storage and use of the syringe.

DETAILED DESCRIPTION OF THE DRAWINGS

The conventional device for protecting against needlestick injuries is shown inFIG. 1. This prior art device1includes a syringe2with basic structures. The tube3holds the fluid to be delivered to the patient. The plunger4creates a seal with the interior of the tube3, such that movement of the plunger4either draws fluid into the tube3or dispenses fluid from the tube3. At the end opposite the plunger4, there is a hub5, and a needle6is mounted on the hub5. The hub5engages the tube3to create a pressure seal, such that fluid flows out of the hollow needle6from the tube3.FIG. 1shows a prior art cap7, which covers the needle6. In this device1, the syringe2covered, preventing needlesticks. The prior art includes other manually operated caps, which require use of both hands in order to cover the needle.

The present invention improves upon this prior art technology in the form of a protection device10, shown inFIGS. 2 and 3. The present invention includes a syringe12, which is also comprised of a basic structures: a tube14, a plunger16within the tube14in liquid-tight connection, and a needle18mounted in a hub20. The hub20is placed at a tip of the tube14on an end opposite the plunger16. These basic structures make the present invention compatible with all types and sizes of existing syringes. The syringe12is operated by moving the plunger16back and forth, within the tube14. This basic action is not hindered by the present invention.

FIGS. 2 and 3also show a sheath means22for covering the needle18, whereinFIG. 2shows the needle18in the sheath means22andFIG. 3shows the needle18protruding from the sheath means22. The sheath means22functions as a protective shield against needlestick injuries in the position shown inFIG. 2. The tip of the needle18cannot contact any patient or healthcare worker when in place around the needle18. The sheath means22has a hole24at a distal end26thereof, such that a first position is set when the needle18is housed in the sheath means22(FIG. 2) and a second position is set when the needle18protrudes from the sheath means22(FIG. 3). The sheath means22is hollow with the syringe12being completely removably engaged to the sheath means22. Additionally, the sheath means22is generally cylindrical inFIGS. 2 and 3. The sheath means22of the present invention may also have various different shapes, compatible with a syringe or even a non-cylindrical syringe.

The present invention10also includes an actuation means28for moving between the first and second positions. Importantly, the actuation means28is placed in closer proximity to the plunger16than to the hub20. This position allows for use of the device10with only a single hand. The sheath means22can be gripped by the fingers of the user, and the thumb engages the actuation means28. Furthermore, the thumb may also be able to engage the plunger16for accomplishing the sheathing and fluid delivery in one hand. The actuation means28is also hollow, such that the syringe12passes through the actuation means28. The device10can be sized to fit a variety of different syringe12sizes. It is important to note that the syringe12is fixably attached to and within the actuation means28. The fixed connection between the syringe12and actuation means28links the movement of the syringe12relative to the sheath means22with the actuation means28. The syringe12extends through the actuation means28and the sheath means22, and the plunger16remains actuatable for dispensing from the tube14. The needle18is in either first or second position relative to the sheath means22.

FIGS. 2 and 3also show a button means30for manual control of the actuation means28. The button means30is placed closer to the end of the tube14with the plunger16in order to facilitate the single hand action of the device10. A pressbutton30is shown inFIGS. 2 and 3, and other button means30are also known.FIGS. 4,5, and6all show various embodiments of the button means30.FIG. 4shows a device100with the syringe102, sheath means104, and actuation means106. The button means108is a push rod, which can be activated by pressing the rod toward the needle end. Another possibility is shown inFIG. 5, wherein the button means208of the device200is a rotary device. Using a single hand, the thumb of the user can spin the button means208to force the actuation movement of the actuation means206. The syringe202and sheath means204are moved in the same manner as the previous embodiment for the protective function.FIG. 6shows yet another variation of the device300of the present invention with a button means308. In this example, the button means308is a raised bump on the actuation means306. Squeezing the bump activates the actuation means306to move the syringe302relative to the sheath means304. Additional button means are possible for the present invention, including switches or levers. Importantly, the button means30must be compatible with single hand use and placement in relative close proximity to the plunger16.

FIGS. 2 and 3also show a locking means32. This locking means32can prevent inadvertent activation of the button means30.FIGS. 2 and 3show the locking means32as a slide member that blocks the pressbutton of the button means30from being pressed. Other known locking means32may also be part of the present invention10. This locking means32must also be placed in closer proximity to the plunger16and the actuation means28than to the hub20. A single hand is able to engage the locking means32, the button means30, and the plunger16. Another variation is shown inFIG. 4with the rotary button means208on the device200. There is a status indicator210on the actuation means206, which provides a visual cue to identify the locked or unlocked or sheathed or unsheathed status of the device200. Other status indicators210can be used for the other various embodiments of the device in any of theFIGS. 2-5.

FIGS. 7 and 8show partial sectional and schematic views of a more particular embodiment of the sheath means22and actuation means28of the device10of the present invention. This embodiment is illustrative of a single embodiment only. Similar toFIGS. 2 and 3,FIGS. 7 and 8show a sheath means22for covering the needle18, whereinFIG. 7shows the needle18in the sheath means22andFIG. 8shows the needle18protruding from the sheath means22.FIGS. 7 and 8show the attachment of the syringe12to the sheath means22and the actuation means28. The sheath means22has screw threads34at an end opposite the hole24.

The actuation means28includes a toothed sleeve36fixedly attached and friction fit to around the syringe12, having teeth38pointed away from the needle18. This toothed sleeve36is fixed connection to any size syringe12. In particular, the toothed sleeve36may attach to the tube of the syringe12. Movement is translated to the syringe12through this connection. The actuation means28further includes a sleeve cam40with complementary teeth42to engage the toothed sleeve36and an abutment member44. The actuation means28has a collar member46with complementary screw threads48, which engaging the screw threads34of the sheath means22. The screw threads48connect the sheath member22to the actuation means28, even though the sheath means22slides into the actuation means28. The collar member46has an interior volume50housing the toothed sleeve36and the sleeve cam40, and there are protrusions52within the volume50extending inward to engage the teeth38of the toothed sleeve36. The collar member46further includes a complementary abutment member54at an end opposite the screw threads48.

There are springs to power the single hand “click” action of the actuation means28. A first compression spring56extends between the abutment member44of the sleeve cam40and the complementary abutment member54of the collar member46. A second compression spring58extends between the toothed sleeve36and the sheath means22. A shell member60covers the collar member46and connection between the sheath means22and the actuation means28.

The button means30moves the sleeve cam40relative to the collar member46. For example, the shell member60can abut against the complementary abutment member44of the sleeve cam40on a side opposite the first compression spring56. The button means30in this instance moves the shell member60to move the sleeve cam40, compressing the spring56. Alternate button means30move the sleeve cam40with or without using the shell member60.FIGS. 2,3, and5are possible examples of a button means30moving the sleeve cam40without affecting the shell member60.

The device10of the present invention uses “click” action to move the needle18between the first position (sheathed) and the second position (unsheathed). The button means30engages the sleeve cam40to compress the first compression spring36by the abutment member44towards the complementary abutment member54of the collar member46. The sleeve cam40pushes the toothed sleeve36toward the screw threads34, and the sleeve cam40stops when the teeth38of the toothed sleeve36engage the protrusions52of the collar member46and release the complementary teeth42. Then, the first compression spring56returns to full extension, and the second compression spring58is compressed. The needle18is now in the second position. The teeth38, complementary teeth42, and the protrusions52are shaped in slanted or sloped forms to be coordinated. A gradual abutment is formed, such that the click action is the transition from mounting and releasing the teeth38on the protrusions52.

To release the teeth38, the button means30engages the sleeve cam40to compress the first compression spring56by the abutment member44towards the complementary abutment member54of the collar member46again. This time, the complementary teeth42of the sleeve cam40engage the teeth38of the toothed sleeve36until the teeth38disengage from or slide off the protrusions52. The first compression spring56returns to full extension, and the second compression spring58returns to full extension. The needle is now in the first position. The needle18is returned to the sheath means22, as the amount of compression of the second compression spring58set the amount of displacement of the needle18relative to the sheath means22.

The present invention further includes a third position, corresponding to retracting the needle18even further. The toothed sleeve is shaped with teeth and protrusion for these multiple levels of displacement of the second compression spring. Furthermore, the actuation means and sheath means correspond in shape to the syringe for fixed engagement of the toothed sleeve. Even if the syringe is not cylindrical, the actuation means and sheath means can be adapted. The present invention includes non-cylindrical structures. The sheath means can be linear along a side of the syringe, and the corresponding structures adapt according to this placement. The actuation means can also be made linear or rectangular or another shape compatible with the syringe.

The method of protecting against needlestick injuries, using the device of the present invention includes covering a needle of a syringe with a sheath, attaching an actuator fixedly to the syringe, moving the needle to the second position for transferring to and from the tube, moving the needle to the first position for storing the syringe for repeat access, repeating movement from the first position and the second position until completing use of the syringe, and disposing of the syringe after use. The syringe is comprised of a tube, a plunger within the tube in liquid-tight connection, and the needle mounted in a hub. The sheath has a hole at a distal end thereof. The needle is housed in the sheath in a first position relative to the sheath. The actuator moves the needle from the first position to a second position and between the first and second positions. The needle being protruded from the sheath through the hole in the second position. The method may include engaging a lock when the needle is in the first position, and releasing the lock to move the needle from the first position to the second position.

The present invention provides a device to protect against needlestick injuries. The needle is sheathed or even retracted to increase safety for those handling the syringe. The syringe can be fitted with the other parts of the device before any contact so as to reduce risk of injuries while setting up the device. The protection device of the present invention operates by a single hand, which is important for surgical situations. The syringe is used more than once, and the syringe is left laying on a tray or cart near healthcare workers. The present invention has particular applicability to operating room procedures, where it is common to require syringes to be close by and immediately ready for use. The present invention also presents single use and disposable options, depending upon the materials used to construct the parts. The sheath and actuator can even be adjusted to be compatible with existing sizes and types of syringes and other sharps. Proper precautions, such as the sheath in the present invention, can be invaluable for avoiding needlesticks in other situations besides the operating room. Additionally, the device allows reuse of solutions, anesthetics, and other chemicals. The present invention is an easy and effective way to prevent being stuck by uncovered needles.