Safety needle introducer and universal needle protector for vascular access devices

A needle point protective device for hypodermic and intravenous needles, catheter introducers, and similar devices protects users from injury and infection. The needle point protective device includes a needle point guard that is slidably mounted within the needle handle. In use, the needle point guard is integral with a cannula guide that is engaged with the needle cannula with enough force to cause the needle cannula to be subject to spring tension when the needle point is retracted proximal to the needle point guard, the needle point springs downward and behind the needle point guard. In one embodiment, the needle point guard is held in position manually as the needle is retracted. In another embodiment, the needle point guard is held in place automatically as the needle is retracted.

FIELD OF THE INVENTION

The present invention relates to needle point protectors and assemblies of devices including needle point guards that are used for safety purposes with hypodermic and intravenous needles.

BACKGROUND OF THE INVENTION

The dangers of infection from accidental contact with the sharpened points of used hypodermic needles are well documented. The proliferation of Human immunodeficiency Virus (HIV), combined with the increasing incidence of other bloodborne pathogens such as Hepatitis B Virus and Hepatitis C Virus, present healthcare workers with a serious occupational hazard. More than twenty known bloodborne pathogens, which are transmitted via blood and bodily fluids, are present inside the bore of a used needle and can be transmitted to another person after the needle has been used with an infected patent. The presence of any of these pathogens in infected patients poses a risk of transmitting a deadly disease to healthcare workers when virtually any procedure is performed in which a needle penetrates the patient's skin.

Infectious diseases have become the third leading cause of death; the prevalence of those diseases creates a growing need for needle protection devices that provide a margin of safety to the healthcare worker. Healthcare workers routinely perform several types of invasive hypodermic and intravenous procedures, such as injecting medicine, collecting blood, establish intravenous (i.v.) fluid administration, and inserting indwelling intravenous catheters. During or after these procedures, nurses and other healthcare personnel are routinely injured by the exposed sharpened end of the needle after use on a patient. Although the danger exists at several points in time, an injury by a needle point, sometimes called a “needle stick” injury, is most likely to occur between the moment that a needle is withdrawn from a patient and the time at which the contaminated needle is safely discarded.

The jobs of approximately 5.6 million workers in the United States place them at risk for accidental needle stick injuries. Medical literature cites approximately one million reported needle stick accidents that occur in the United States each year, with an additional 700,000 believed to be unreported. Prior to high rates of HIV and serum hepatitis, a needle stick injury was considered a routine nuisance that was accepted as part of providing patient care. However, a needle stick injury now carries the potential for a life-threatening transfer of infectious disease.

The great majority of hypodermic and intravenous needles are intended for a single use on an individual patient and are manufactured in a variety of designs, lengths, and gauges. Most simple needles are discarded after a single use into a biohazard collection container that contains the used needle and may also break the needle to prevent re-use. Despite all the obvious dangers associated with the use of hypodermic and intravenous needles, and the availability of many safety needle devices, unguarded needles are still routinely and predominately used in the marketplace. Due to cost considerations, many medical institutions continue to purchase unsafe needle devices.

One problem with many safety needle devices is that they are expensive and difficult to manufacture because of the intricacy of the design and the use of multiple components as part of the safety mechanism. Even when used, the incidence of failure is well known with many existing needle safety devices. Another problem associated with some of the present devices is that the protective device itself can injure the healthcare practitioner. When a protective device is difficult or clumsy to use, the action required to use the device can actually cause injury. As would be expected, the greater the number of active manipulations that must be made by hand with any safety apparatus containing a needle, the greater the risk of contact with the point. When the mechanism of use is awkward or uncomfortable, the risks naturally increase.

Moreover, any time that a safety device adds cost to a system, the added marginal cost will cause the safety device to be abandoned, or used less frequently, in a finite number of cases. Thus, simplicity and low cost are primary concerns when providing any safety device for use with an existing system. To enhance simplicity and reduce the costs of any safety system, important design criteria impact both the manufacturing process for producing the device and the operational use parameters of the device in everyday practice. Furthermore, the ideal safety device offers universal design that may be used with a large number of common devices, while also being able to be specifically designed and configured to cooperate with the underlying systems for which the safety margin is provided.

Therefore, the dangers inherent in the use of hypodermic and intravenous needles would be reduced by a safety device that has a low cost of manufacture, a simplicity of use, and that provides an effective needle protection apparatus with universal application.

SUMMARY OF THE INVENTION

The present invention is a needle point protector device and assembly for hypodermic and intravenous needles, catheters, introducers, and similar devices. The invention includes a needle cannula guide and needle point guard built into an integrated device such that the motion of the needle cannula, exerted by a single sliding motion of an integrated handle after needle use, causes the cannula and the point of the needle to pass within a needle guide and causes the needle point to engage the needle point guard in a manner that permanently fixes the needle cannula and needle point in a position and orientation that provides safety to the user. The needle point engages the needle guard when the handle of the protector, which is fixed to the needle cannula, is moved to retract the length of the needle cannula along a needle guide to a fully retracted position defined by a position where the needle point is proximal of, and no longer supported by, the needle guide. At this point, an existing tension exerted on the needle cannula causes the needle cannula and point to depart from the position within the needle guide and to spring into place proximate to or in engagement with the needle point guard. The needle point guard is proximate to the needle guide and oriented in the direction towards which the tip is biased by the tension, typically downward or in the direction of the needle guard.

In a preferred embodiment, the needle protector handle slides along a path defined by an elongate element that is integrated with and attached to the needle point guard and needle cannula guide. The elongate element traverses the handle through a channel or is attached thereto with other connector such that the protector handle slidably engages the element along a defined length thereof. Preferably, the body or housing of the handle is traversed by the elongate element to slide along a range of motion that includes an open position where the needle cannula is supported by the guide and wherein the needle point extends distally of the guide, the guard, and the elongate element. This open position is the ordinary configuration in which the needle is used to penetrate the skin of a patient. A closed position is defined by manipulating the device into a position that causes the needle point to engage the needle point guard, specifically, by moving the handle along the elongate element in a distal to proximal direction. During this motion, tension is exerted on the cannula by the orientation of the cannula in the handle body and positioning of the cannula within the needle guide until the point clears the needle guide and the tension is released causing the point to move into place proximate the point guard. The motion of the handle is restricted by a stop, for example at the proximal end of the elongate element, that prevents further motion of the protector handle beyond the point at which the tension on the needle cannula is released to spring the needle point into the safety position.

For some applications, the elongate element is capable of linear expansion or “telescoping” such that the overall length of the elongate element may be less than the total distance necessary, which is essentially the distance comprised of the sum of the length of the exposed needle cannula and the length of the protector handle. In this embodiment, when the elongate element expands from a minimum length to a maximum length as the needle cannula is withdrawn to the point where the needle point departs from the needle guide and springs into position at the needle point guard. In this embodiment, in the closed or unexpanded position, the overall length of the elongate element and the introducer handle may be shorter than the length of the cannula between the distal portion of the handle and the needle guide. However, as noted above, the telescoping action of the elongate element is sufficient for the handle to be withdrawn along the path of the elongate element such that the needle moves into position at the needle guard prior to the point at which the proximal portion of the handle abuts the stop of the elongate element.

Preferably, the proximal portion of the needle cannula is entirely contained within the body or housing of the handle such that it is fixed therein. The handle of the protector is comprised of a body or housing that contains the most proximal portion of the cannula and may completely contain a chamber in fluid communication with the proximal end of the cannula of the needle. The needle protector handle or body also contains a port that is preferably located at the most proximal portion of the handle body and is also in fluid communication with the chamber. The port has a discrete closure apparatus or fixture that seals and engages the port to contain fluids that enter the chamber through the needle cannula. In a preferred embodiment, the closure may have a septum or other dedicated sampling port for retrieving fluids within the chamber without removing the closure.

In use, the motion of the needle cannula and the needle point out of the guide and into proximity with the needle tip guard is caused by the motion of the handle in combination with the tension that is exerted by designing the needle cannula to be positioned relative to the needle guide and the elongate element such that tension is exerted on the cannula. Preferably, tension is exerted on the cannula along the entire range of motion between the open and closed position, but is specifically exerted when the portion of the cannula nearest to and comprising the needle point when the point reaches the most proximal point of the path along which it slides. As noted above, the orientation of the needle cannula relative to the elongate element and the needle guide provides the tension on the cannula that springs the point into the safety position near the needle guard. The tension may be provided by positioning the horizontal axis of the needle cannula within the body of the housing in a manner that is essentially parallel to the elongate element, but is below the plane defined by the height of the needle guide. Alternatively, the needle can be fixed at a slight angle such that the proximal point of the needle cannula is embedded in the body of the handle to form a slight deflection in the needle cannula along its length toward the needle guide. In either case, because of the tension exerted on the needle cannula, the cannula contacts the guide and continues to engage the guide while the handle is withdrawn along at least a portion of the length of the elongate element. As noted above, when the needle point or tip moves proximally of the needle guide, the existing tension on the needle cannula causes the needle to move to a point proximate to or in engagement with the needle point guard.

The range of motion of the handle is defined in the most distal direction along the elongate element by contact between the handle body and a structure integral with the needle guide, such as the body of the guide itself, the shield member (described below) or a forward stop element of any mechanical expedient that prevents further distal motion of the handle. Similarly, the motion of the handle in the most proximal position is preferably defined by a step stop element that contacts the handle to arrest the motion proximally. While the point of contact at either extreme of the path of travel of the handle is conveniently made with the most distal and most proximal portion of the handle, respectively, the contact point can easily re recessed within the body and the defined axial length of the handle body (discussed below) is modified accordingly.

For ease of use, the needle point guard is integral with the needle cannula guide in a shield member adapted to be held by the hand and that is located on at least one side of the cannula guide, such that the needle protector handle can be conveniently and simultaneously grasped by the user to withdraw the needle following use with a patient. In a preferred embodiment, the shield member is integral with, and oriented generally perpendicular to, the elongate element and has a distal portion shaped to accommodate a companion device with which the protector is used.

For example, the shield member may have a planar structure on both sides of the needle guide such that either side of the shield member can be conveniently grasped when the needle cannula is inserted through the companion device, such as a catheter insertion device that is axially separated or “peeled” apart, sometimes referred to as a “T-peel.” See U.S. Pat. No. 5,951,518, PCT WO 99/22804. The shield member shape that accommodates “a T-peel catheter introducer is simply one example of the design and configuration of the distal end of the needle point protector device that surrounds and contains the needle cannula guide and point guard and which facilitates the attachment or operational combination of the overall protector device with a companion device. The companion device may be the T-peel catheter introducer, or may be any different apparatus for vascular access that is used as described herein. Depending on the design of these companion devices, the distal portion of the needle point protector may be shaped for close, intimate contact and attachment at the point of the connection to the needle point protector of the invention, or may simply be shaped to accommodate easy manipulation of the distal portion of the needle point protector and the companion device. However, in a particularly preferred embodiment, the distal portion of the needle point protector is specially configured to removably attach the companion device such that the needle point guard function of the invention is provided passively through the motion of the handle achieved during withdrawal of the needle from the patient. The configuration may be provided by altering the shape of the protector itself or may be provided by an additional, reversible, locking feature.

As is explained in further detail below, the needle point protector assembly is comprised of an assembled combination of the needle point protector and a companion device, including an introducer such as a T-peel inserter or other venous/arterial access devices, or other devices that are coupled to a needle in use. The assembly comprises, or is advantageously used with, a wide variety of devices for safe access to the venous/arterial system or for needle placement or use in any environment where a needle is used on a patient and has the potential to transmit disease. Specifically, the assembly of the invention includes the needle point protector described herein in combination with companion devices such as catheters generally, other venous/arterial access devices, including, (peripherally inserted central catheters (PICC catheters), guide wires, spinal tap needles, epidural needles, intravenous fluid administration sets, short peripheral catheters, midline catheters, neonatal catheters, biopsy needles. In clinical use, the needle protector of the invention can be provided in a kit with a companion device such as the T-peel introducer, or configured as a guide wire, spinal, epidural, biopsy, or other specialty needles sold as stand-alone products.

In a particularly preferred embodiment, the needle point protector is reversibly attached to an introducer device such that the needle point protector function of the invention is essentially automatic during use. In this embodiment, withdrawal of the needle during placement of the companion device necessarily activates the needle point protector function of the invention and provides this function passively to the companion device. In this embodiment, the safety function of the device of the invention is referred to as passive because the needle protection function occurs without separate manipulation of the needle point protector relative to the insertion device, such as the T-peel inserter, because the action of removing the needle during vascular access necessarily causes the actuation of the needle point to the appropriate safety position relative to the needle point guard.

DETAILED DESCRIPTION OF THE INVENTION

Referring toFIGS. 1A and 1B, a needle for penetrating the skin and, for example, providing access to the venous or arterial system has a point1at the distal most end and a cannula2which contains a bore (not shown) through the entire length thereof for fluid communication through the needle cannula2. The proximal end of the cannula2terminates in a needle protector handle3. A proximal portion of the cannula is contained within the handle3and a length thereof is preferably over-molded within the body or housing of the handle3such that the needle cannula2traverses less than half of the overall axial length of the handle3and terminates in a flashback chamber10that is contained within the body of the handle3and is in fluid communication with the cannula2. The chamber10features a sampling port11at the proximal end that is preferably molded directly into the body of the handle3. The sampling port11has a closure12that sealingly engages the port11to prevent fluids contained in the flashback chamber10from leaking. In a preferred embodiment, the closure12has an integrated septum (not shown) or other sampling port so that fluids contained within the chamber10can be accessed for testing or other clinical purposes.

In this configuration, the fluid pathway begins at the needle point1, passes through the cannula2, continues through the portion of the cannula that traverses the handle3, enters into the chamber10, and may be accessed through and is controlled and contained by the closure12in port11. In use, the placement of the needle point1in a vein or artery is accomplished with the device of the invention in the “open” configuration wherein the needle extends distally to its maximum length. Verification of proper placement of the needle point in a vein, artery, or other fluid containing body cavity is verified by the appearance of fluid in the chamber10. Typically, the needle point protector device13of the invention is combined with a companion device that is intended to be placed within the body. Once the proper placement of the needle point1is verified, the needle can be withdrawn, as is explained in further detail below, while the companion device remains in place.

In a preferred embodiment, the body or housing of the handle3is conveniently grasped on both sides by the hand for ready movement of the entire needle. Reproducible movement of the needle cannula2is provided by engagement of the handle3with an elongate element4that has an axial length which is generally parallel with the axial length of the needle cannula2. In this context, “axial length” refers to the long length of the needle cannula2through which the bore passes and, accordingly, the long length of the elongate element4about which the handle3slides. Reproducible linear movement of the needle and handle relative to the overall needle protector device is provided by a channel9in the body of the handle3through which the elongate element4passes and about which the handle3slides along the length of the elongate element4. Thus, the elongate element4traverses at least a portion of the body of the handle3such that the handle3slides along a predetermined length of the elongate element4and, by virtue of its length and structures located at either end that define the range of motion, essentially defines the path along which the handle3passes. In turn, this range of motion defines the movement of the needle cannula2and point1between what is described as the open and closed positions.

To define the range of motion, the most proximal portion of the elongate element is comprised of a stop8or other mechanical means that limits the rearward or proximal motion of the handle3and which prevents the handle3from becoming detached from the elongate element4and the overall protector device3. A mechanical stop8is a preferred structural element for limiting the motion proximally of the handle3, but any structure, such as a taper in the elongate element4or other structural expedient can readily serve the identical mechanical purpose. At the distal end of the device13, the range of motion of the handle3is limited by the shield number5.

Referring toFIG. 1B, the distal most portion of the elongate element is integrally formed with a shield member5that is further comprised of the needle cannula guide6and the needle point guard7. In use, the needle cannula2slides along its length within the guide6as the handle3is moved along the elongate element4. The needle guide6may take any shape that serves to confine the needle cannula2in a stable, confined orientation and which contains the needle cannula2throughout the entire range of motion of the handle3. As illustrated inFIG. 1B, a simple form for the needle guide6is a V-shaped recess in the body of the shield member5such that the bottom or apex of the V is aligned with the length of the elongate element4and the axial portion of the cannula2. The shield member5is also preferably comprised of the needle point guard7(not shown) positioned immediately below the guide6but integral in the same structure of the shield member5. The needle point guard7may have a lip or other concave depression in the surface of the proximal side of the shield member5(i.e. facing the handle3) such that when the needle point1drops below the apex of the guide6, the needle point1is fixed in place and prevented from moving upward and back into position above the bottom of the guide6such that the needle point1could advance distally. As is apparent fromFIG. 3, when the needle point1drops below the needle guide6the point of the needle is fixed in the safety position such that the point of the needle cannot injure the user and cannot be moved in any direction, particularly axially along the length of the elongate member4. The shield member5may also have a short extension (not shown) that extends distally and rests underneath a peelable inserter or other companion device (seeFIGS. 2-10) to prevent rotation or movement of the companion device relative to the protector device.

As will be apparent from the description and figures herein, the needle point protector device13is preferably comprised of the needle, the elongate element4having a stop means8, the shield member5, together with the needle guide6and needle point guard7structures integrated therein, and the handle3integrated together and constructed with specific dimensions to facilitate operative function for the open and closed positions of the device. Also, the overall shape, dimensions, and configurations of the device are designed specifically to function with the catheter, introducer, or other device with which the needle point protector13device of the invention is used. As will also be apparent from the following drawings and description, the distal most portion of the needle point protector13, specifically, a structure that is integral with or extends distally from the shield member5and which is directly abutted by the handle3in the open position is most specifically designed and shaped to match the design and shape of a companion device. In the embodiment ofFIGS. 1A and 1B, the shield member5, as the distal most structure of the needle point protector device13, is advantageously shaped to facilitate use with a T-peel introducer. Accordingly, as is apparent fromFIG. 1B, the shield member5of this embodiment has a similar size and profile to the wings of a T-peel introducer such that both may be easily grasped by the hand when the needle is used to introduce the T-peel through the skin of a patient, i.e. to access the venous or arterial system of the patient. As is seen in the figures and descriptions below, where other companion devices are used as part of a complete assembly, the distal most portion of the needle point protector device13will have a different shape and profile to accommodate the most proximal portion of the companion device which mates with the distal most portion of the needle point protector device13.

Referring toFIG. 2, the embodiment ofFIGS. 1A and 1B, andFIGS. 3A and 3B, is shown at an intermediate point in the operation of the device between the open configuration (FIGS. 1A and 1B) and the closed configuration (FIGS. 3A and 3B) such that the length of the needle cannula2is engaged by the needle guide6at roughly a midpoint along the length of the needle cannula2during the process of withdrawing the handle3rearward or proximally along the axial length of the elongate element4. As the handle3moves along the elongate element4, tension is exerted along the needle cannula2to bias the motion of the needle cannula2to continually engage the needle point guide6until the proximal point in the range of motion of the handle at which point the device achieves the closed position as illustrated inFIGS. 3A and 3B.

Referring now specifically toFIGS. 3A and 3B, the needle point protector13is shown fixed in the closed position wherein the safety function of the apparatus is provided by the position of the needle point1below the needle guide6and in close engagement, or actual contact, with the needle point guard7such that an accidental needle stick injury is prevented. Also, in this specific configuration, the most proximal portion of the handle3preferably engages the stop means8at the most proximal end of the elongate element4. Referring toFIG. 3A, the maximum length “A” of the elongate element4is preferably just slightly greater than that of the length “B” of the exposed needle cannula2, i.e. that portion of the needle cannula not contained within the housing of the handle3, when added to the overall axial length “C” of the handle3. Accordingly, the overall distance of the needle cannula2that is extended from the body of the handle3, when added to the overall axial length of the handle3, very closely approximates the total length of the elongate element4between the stop8and the needle point guard7that is integrated in the shield member5such that, when in the closed position, the handle3and needle cannula are incapable of movement in either direction along the elongate element4and the needle point1remains in close contact with the needle point guard7. It is important that the length of the elongate element4closely approximates the combined lengths of the exposed portion of the needle cannula2and the axial length of the body at handle3(Length A=Length B+Length C inFIG. 3A) so that a portion of the finger or hand of a healthcare worker cannot fit between the needle point1and the needle point guard7when the needle is withdrawn to place the device in the closed position. As described above, the “axial length” of the handle3refers to the length of the handle3along the axis defined by the length of the elongate element4and the needle cannula1.

As noted above, a tension is exerted on the needle cannula2by the orientation of the cannula2within the handle3and the position relative to the needle guide6. As demonstrated in comparison ofFIGS. 1A,1B,2,3A, and3B, the tension exerted on the needle cannula2against the needle guide6results in a displacement of the needle cannula2and the needle point1in a direction dictated by the tension such that the needle point1is moved into the desired position relative to the needle point guard7. Preferably, the tension springs the needle point1downward to engage the needle point guard7and then rest a portion of the cannula2along the elongate element4. In this configuration, as is apparent fromFIG. 3A, the movement of the needle point1or cannula2in a forward or more distal direction is completely prevented by the needle point guard7and the integral structure of the shield member5.

Referring toFIGS. 4A and 4B, the needle protector device13is shown attached to a peelable introducer20(T-peel) wherein the wings21of the T-peel introducer20are in close engagement with the shield member5of the protector13. As is apparent fromFIG. 4A, when used as a companion device with the safety device13of the invention the T-peel has a sheath cannula22that runs outside a substantial length of the cannula2, while leaving the point1uncovered to traverse the skin. In use, the needle protector device13begins in the position shown inFIGS. 4A and 4BandFIGS. 1A and 1Bas the closed position, wherein the needle is advanced to the most extended position distally and wherein the handle3abuts the shield member5. In the embodiment ofFIGS. 4A and 4B, the T-peel introducer20is advantageously attached to the protector device13in the open position for introduction to the patient. In this embodiment, the exposed length of cannula2(Length B inFIG. 3Ais greater than the length of the sheath cannula22of the peelable introducer.

The needle is introduced transdermally to the patient thereby placing the T-peel introducer along the needle cannula2simultaneously with placement of the needle. When the clinician determines that the needle has been properly placed, for example by viewing fluid in flashback chamber10, the needle may be withdrawn while leaving the T-peel introducer20in place. To withdraw the needle, the handle3is pulled rearwardly, or proximally, along the elongate element4until it abuts stop8. The T-peel introducer20remains in place to facilitate its ordinary function, while the act of withdrawing the handle3causes the needle to retract into the safety position and to engage the needle point guard7as described previously.

Referring toFIGS. 5A and 5B, the needle point protector13is shown coupled with an over-the-needle (OTN) catheter30such that the most proximal portion of the catheter30directly contacts and abuts the distal portion shield member5of the needle point protector13. As noted above, the distal most portion of the protector13is configured according to the shape of the proximal portion of the companion device with which the protector13is used to preferably yield a sealed connection. In this embodiment, the distal most portion of the protector13is configured to feature a fixture (not shown), such as a male luer taper that conformingly engages the companion device, in this embodiment, the proximal portion of the over-the-needle catheter30. In use, the needle is introduced in the manner described in connection withFIGS. 4A and 4B, namely, the needle is introduced transdermally i.e. to the vascular system of a patient in a conventional fashion, while simultaneously introducing the catheter30and the integrated catheter cannula31that surrounds the needle cannula2when the companion device is attached to the needle point protector13. Once proper placement of the catheter30is achieved, the needle is removed by actuating handle3to move the needle point protector device13into the closed position, leaving the catheter30in the desired placement while providing a margin of safety from a needle point injury when the needle is withdrawn.

Thus, as is apparent fromFIGS. 5A and 5B, the use of the introducer13introduces the combination of the needle point1, the needle cannula2, and the proximal portion of the shaft31of the over-the-needle catheter30through the skin of the patient, for example to provide venous or arterial access. As described above, the handle3is withdrawn by a proximal motion along the length of the elongate element4such that the cannula2and the point1are positioned to the point at which the tension on cannula2displaces the needle point1out of the needle guide6and into engagement with the needle point guard7, preferably when the handle reaches the most proximal position along the elongate element4and is abutting the stop8. At this point, access to the venous/arterial system can be provided by accessing the port11, the selectable access port in fixture12, or by removing the protector13entirely leaving only the over-the-needle catheter in place. An analogous methodology is followed for any of the devices with which the protector13is used such as intravenous solution administration sets, biopsy needles, guide wires, and other similar apparatus.

Referring toFIGS. 6A and 6B, an embodiment of the invention includes a separate fixture that reversibly attaches or locks the companion device to the distal most end of the protector13. A discrete locking fixture40preferably extends from the distal most end of the shield member5of the protector device13and may traverse the portion of the shield member5comprised of the guide6such that when companion devices are brought into contact with the distal end of the protector13, the locking fixture40is manipulated to attach the companion device in a manner that allows the needle cannula2to enter the complimentary shaft or cannula on a companion device and wherein the locking fixture40engages the proximal most portion of the companion device to hold the companion device and the protector13into a single functional needle point protector assembly. In this assembled configuration, the companion device and protector13are functionally joined so that the motion of the needle handle3to retract the needle into the safety position may be performed without separate manipulation of the companion device or the protector device13.

FIGS. 6A and 6Bshow the locking fixture40attached to the proximal most portion of an over-the-needle catheter introducer30. In a preferred embodiment, the locking fixture40is a simple wire that is affixed to the shield member5on both sides of the needle cannula2and needle guide6to essentially straddle the cannula2and the proximal portion of the companion device. Ideally, the locking fixture40is configured to engage a structure on the companion device that provides for conforming engagement between the protector13and the companion device when the locking fixture40is actuated. In use, the protector13, in the open position, is brought into attachment with the companion device. Then, the locking fixture40is positioned to engage the proximal portion of the companion device in an orientation to hold the companion device in contact with the distal most portion of the protector13. The combined assembly is then used in the manner dictated by the clinical circumstances, followed by retraction of the needle by motion of handle3into the closed position. When indicated, the entire protector13is then removed from the companion device by reversing the attachment of the locking fixture40to disconnect the protector13from the companion device.

Referring toFIGS. 7A-7C, an embodiment of the invention is shown wherein the distal most portion of the protector13has connector32suitable for engaging an introducer for an apparatus such as a guide wire and which features a needle cannula2′ of extended length. Certain clinical applications require that long-straight needles be used for venous or arterial access and the protector13design of the invention can accommodate any needle cannula2′ length by altering the design of the elongate element4accordingly. Most simply, the elongate element4can simply be lengthened to a measurement, consistent with the embodiment described above inFIG. 3A, such that the total length “A” of the exposed cannula2plus the axial length of the handle3B is substantially identical to the elongate element4. An extended length of the elongate element4can also be provided with a simple extension or telescoping capability. The telescoping extension capability requires a separate movable elongate element4′ that slidingly engages the elongate element4and wherein the two structures move substantially coaxially with one another. Preferably, either the elongate element4, or the movable elongate element4′ that extends the greatest distance proximally from the needle cannula2also contains the stop means8to arrest the motion of the handle3once the needle point is in position proximate to needle point guard7.FIGS. 8A-8Cshow the embodiment ofFIGS. 7A-7Cwherein the elongate element4and movable elongate element4′ are positioned at a maximum extendable length “C” to accommodate the long needle cannula2′ and wherein the handle3is at the most proximal position abutting stop8to place the needle protector device13in the closed position.

As indicated above, an embodiment of the invention provides an essentially passive function for the safety needle point protection aspect by removably attaching the companion device to the distal most portion of the protector13using a fixture on the device13. As is illustrated inFIGS. 9A-9C, the shield member5is configured to have an extension comprised of an attachment means50to engage the companion device in such a manner that the two devices are joined into a single assembled unit for use. As is specifically shown inFIG. 9B(wherein the handle3is not shown), the attachment means50is specifically configured to engage a companion device by contacting the device in close engagement about at least a portion of the periphery thereof and is configured to resist force applied to the protector13, e.g. by pulling on handle3. In the embodiment ofFIGS. 9A-9C, the shield member5is comprised of the attachment means50that engages the outer edges of the wings21of the T-peel20by providing the shield member5with a shaped extension that acts to reversibly connect the T-peel20to the shield member extension. The attachment means50also prevents inadvertent detachment from the protector13. As noted above, this embodiment is termed a passive device because the needle protective function is essentially added to the companion device, whether it be the T-peel introducer20ofFIGS. 4A-4Cand9A-9C, a catheter ofFIGS. 5A-5C, or any other apparatus used with the device13, without separate manipulation thereof such that the needle protective function is provided to the entire assembly through only the motion of the handle3.

FIGS. 10A-10Cshow the passive aspect of the embodiment ofFIGS. 9A-9Cwherein the needle point1has been retracted to engage the needle point guard7with the T-peel introducer20remaining attached to the attachment means50integrated with the distal most portion of the protector13.

As is apparent from the above description, the precise techniques for using the device of the invention will vary with the companion device to which the needle protector device13is joined to form the integrated assembly. Generally, the companion device is engaged with the distal end of the protector device and positioned such that the needle point1extends through the companion device to be positioned for transdermal insertion into a patient. The entire assembly is inserted transdermally to a position in side the patient dictated by the clinical circumstances. Once the position is correct, the handle3of the device13is withdrawn as described previously thereby changing the configuration of the device from the open to the closed position. At that point, the needle point is in the safety position and the device13is still engaged with the companion device. At this point, the entire device13is removed leaving the companion device in place. Next, the companion device is used in the desired manner, i.e. for the introduction of a catheter, guide wire, separate needle, or other device indicated by the clinical circumstances. In a commercially preferred embodiment of the invention, the needle protector device13is packaged together with a companion device for insertion of a catheter, biopsy needle, PICC catheter, or similar device in a prepackaged kit where the components have been sterilized and prepared for use with a patient and including instructions for use of the needle protector device13and any companion device.

There will be various modifications, improvements, and applications of the disclosed invention that will be apparent to those of skill in the art, and the present application encompasses such embodiments to the extent allowed by law. Although the present invention has been described in the context of certain preferred embodiments, the full scope of the invention is not so limited, but is in accord with the scope of the following claims. All references, patents, or other publications are specifically incorporated by reference herein.