Title of Invention	NEEDLE SAFETY ARRANGEMENT AND A METHOD OF MAKING THE SAME
Abstract	Needle capture mechanisms and arrangements are provided. One such arrangement includes a needle defining a longitudinal needle axis having a sharp distal tip, a shank portion, and a needle feature defining at least one localized area along the shank of increased outer diameter; a needle shield; and a biasing member adapted to exert a generally downward biasing force upon the needle. Another such arrangement includes a needle defining a longitudinal needle axis having a sharp distal tip, a shank portion, and a needle feature defining at least one localized area along the shank of increased outer diameter; a needle shield, the needle shield comprising a pocket formed therein having an inclined surface; a split collet disposed within the pocket, the split collet having a variable inner bore; and a biasing element disposed within the pocket for biasing the split collet toward the inclined surface of the pocket.

Title of Invention

NEEDLE SAFETY ARRANGEMENT AND A METHOD OF MAKING THE SAME

Abstract

Needle capture mechanisms and arrangements are provided. One such arrangement includes a needle defining a longitudinal needle axis having a sharp distal tip, a shank portion, and a needle feature defining at least one localized area along the shank of increased outer diameter; a needle shield; and a biasing member adapted to exert a generally downward biasing force upon the needle. Another such arrangement includes a needle defining a longitudinal needle axis having a sharp distal tip, a shank portion, and a needle feature defining at least one localized area along the shank of increased outer diameter; a needle shield, the needle shield comprising a pocket formed therein having an inclined surface; a split collet disposed within the pocket, the split collet having a variable inner bore; and a biasing element disposed within the pocket for biasing the split collet toward the inclined surface of the pocket.

Full Text	NEEDLE CAPTURE MECHANISMS This application claims priority to U.S. Provisional Application Serial No. 60/633,413 filed December 7, 2004, which is incorporated herein by reference in its entirety. Technical Field The subject invention relates to mechanisms that will effectively and safely capture a needle or other sharp object, thereby placing the needle or other sharp object in a state that makes accidental contact therewith unlikely or impossible. Background Art In the following discussion, certain articles and methods will be described for background and introductory purposes. Nothing contained herein is to be construed as an "admission" of prior art. Applicants expressly reserve the right to demonstrate, where appropriate, that the articles and methods referenced herein do not constitute prior art under the applicable statutory provisions. In recent years, there has been great concern over the contamination of clinicians with a patient's blood and a recognition that blood contaminated sharps must be disposed of to avoid an accidental needle stick. This concern has arisen because of the advent of currently incurable and fatal diseases, such as Acquired Immune Deficiency Syndrome ("AIDS"), which can be transmitted by the exchange of body fluids from an infected person to another person Thus, contact with the body fluids of an AIDS infected person must be avoided. As noted above, if a needle has been inserted into an AIDS infected person, the needle, via its sharp distal tip, is a vehicle for the transmission of the disease. Although clinicians are aware of the need to properly handle blood contaminated sharps, unfortunately, in certain medical environments such as emergency situations or as a result of inattention or neglect, needle sticks with a blood contaminated sharp still occur. As a result of the problem of accidental needle sticks by blood contaminated sharps, various needle shields have been developed. Such devices are disclosed in, for example, U.S. Patent Nos. 5,601,536 and 4,994,041. Devices such as catheters, catheter introducers and guidewire introducers are all examples of the types of devices that can incorporate a needle or other sharp object therein. Catheters, particularly intravascualar (IV) catheters, are used for infusing fluid, such as normal saline solution, various medicaments and total paternal nutrition, into a patent, withdrawing blood from a patient or monitoring various parameters of the patient's vascular system. Peripheral IV catheters tend to be relatively short and, typically, are on the order of about two inches or less in length. The most common type o IV catheter is an over-the-needle peripheral IV catheter. As its name implies, an over-the-needle catheter is mounted over an introducer needle having a sharp distal tip. At least the distal portion of the catheter tightly engages the outer surface of the needle to prevent peelback of the catheter, thereby facilitating insertion of the catheter into the blood vessel. The catheter and the introducer needle are assembled so that the distal tip of the introducer needle extends beyond the distal tip of the catheter, with the bevel of the needle facing up away from the patient's skin. The catheter and introducer needle assembly is inserted at a shallow angle through the patient's skin into a blood vessel. There are many techniques for inserting such a catheter and introducer needle assembly into a patient. In one insertion technique, the introducer needle and catheter are inserted completely into the blood vessel together. In another technique, the introducer needle is partially withdrawn into the catheter after the initial insertion into the blood vessel. The catheter is then threaded over the needle and inserted completely into the blood vessel. To verify proper placement of the catheter in the blood vessel, the clinician confirms that there is flashback of blood in a flashback chamber. The flashback chamber is typically formed as part of the needle hub. Alternatively, where the introducer needle includes a notch, i.e., a hole or opening in the sidewall of the introducer needle, flashback of blood can be observed in the annular space between the introducer needle and the catheter, in the catheter adapter and, where the catheter is an integrated catheter, in an extension tube extending from a side arm formed in the catheter adapter. Once proper placement of the catheter into the blood vessel is confirmed, the clinician applies pressure to the blood vessel by pressing down on the patient's skin over the blood vessel distal to the introducer needle and catheter. This finger pressure occludes, or at least minimizes, further blood flow through the introducer needle and the catheter. The clinician then withdraws the introducer needle, leaving the catheter in place, and attaches an appropriate device to the catheter. Such a device can include a fluid delivery device, a PRN, a deadender cap or a blood pressure monitoring probe. Once the introducer needle is withdrawn from the catheter, the introducer needle is a blood contaminated sharp and must be properly handled. It would be desirable, in general, to provide a needle capture and shielding arrangement having an improved capture mechanism. For instance, some conventional needle capture mechanisms can require a relatively large amount of space within the apparatus into which it is incorporated. Moreover, some conventional needle capture mechanisms require the user to undertake specific steps or actions to activate the capture mechanism; such steps or measures are often not intuitive. Thus there is a need to provide relatively compact needle capture mechanisms that are easy to use. Disclosure Of The Invention Therefore, according to certain embodiments, the present invention comprises a device or method that provides one or more of the following features and advantages: a needle capture device and arrangement that is compact, simple and easy to use, requires no special features or techniques to be operative, and has a relatively low cost. According to one aspect of the present invention, there is provided an arrangement comprising: a needle defining a longitudinal needle axis having a sharp distal tip, a shank portion, and a needle feature defining at least one localized area along the shank of increased outer diameter; a needle shield defining a longitudinal central axis, the needle shield comprising a proximal opening having a diameter great enough to permit passage of the needle shank therethrough, but small enough to prevent the needle feature from passing therethrough, a distal opening having a diameter great enough to allow both the needle shank and needle feature to pass therethrough, and an inner shoulder surface; and a biasing member adapted to exert a generally downward biasing force upon the needle; wherein the arrangement is constructed such that upon drawing the needle completely through the distal needle passage, the downward biasing force of the biasing element causes the needle to become angled downwardly such that the central axis and the needle axis diverge, and the sharp tip of the needle is forced out of registry with the distal needle passage and is trapped within the needle shield by the inner shoulder surface. According to the invention, the above-described arrangement further comprises: a catheter adapter having a proximal end; a catheter mounted within the catheter adapter; and an external coupling housing comprising a proximal end, the external coupling housing being received within the proximal end of the catheter adapter; and wherein the needle shield is received within the proximal end of the catheter adapter. According to another aspect of the present invention, the above-described needle shield is retained within the external coupling housing by one or more of the following: a folded tab, one or more areas of increased outer diameter along the external periphery of the needle shield, an adhesive, a frangible link and a mechanical fastener. According to the invention, the above-described biasing member comprises one or more of: a finger spring in the form of a folded tab cut from the sidewall of the needle shield, a mechanical spring; an elastomeric spring; a pneumatic element; and an electromechanical element. According to the invention, the above-described catheter adapter and external coupling housing are formed from a thermoplastic material, such as a polyamide, a polytetrafluoroethylene, a fluonnated ethylene propylene, a polyurethane, or a metallic material. According to the invention, the above-described needle feature comprises a crimp or a ferrule. According to the invention, the above-described arrangement is constructed such that the needle shield, having a needle captured therein is separable from one or more of the catheter adapter and the external coupling housing. According to another aspect, the present invention provides an arrangement comprising, a needle defining a longitudinal needle axis having a sharp distal tip, a shank portion, and a needle feature defining at least one localized area along the shank of increased outer diameter; a needle shield defining a longitudinal central axis, a proximal through-hole opening and a distal through-hole opening, the needle shield comprising a pocket formed therein having an inclined surface; a split collet disposed within the pocket, the split collet having a variable inner bore; and a biasing element disposed within the pocket for biasing the split collet toward the inclined surface of the pocket; wherein the arrangement is constructed such that as the needle is drawn in toward the interior of the needle shield, the needle feature comes into contact with the split collet, which causes compression of the biasing element such that the split collet no longer contacts the inclined pocket surface and the inner bore of the split collet is expanded, thereby allowing passage of the needle feature through the split collet with a predetermined degree of interference therewith, and further as the sharp distal tip of the needle is completely withdrawn into the needle shield housing, the needle feature passes out of the inner bore of the split collet, thereby removing the aforementioned compression of the biasing element, which causes the split collet to once again be biased against the mclined surface, this also causes the inner bore of the spht collet to constrict such that it is once again smaller in diameter than the distal through-hole opening, as well as the outer diameter of the needle feature, thereby preventing the sharp distal tip of the needle from exiting the needle shield housing According to the invention, the above-described needle shield and/or split collet is formed from a thermoplastic material, such as a polyamide, a polytetrafluoroethylene, a fluorinated ethylene propylene, a polyurethane, or a metallic material. According to the invention, the above-described needle feature comprises a crimp or a ferrule. According to the invention, the above-described biasing element comprises one or more of: a mechanical spring, a metal or plastic clip, an elastomeric element, or magnetic force. According to the invention, the above-described split collet is in the form of an annular ring comprising a plurality of arcuate segments having interfitting end configurations. According to the invention, the above-described split collet is in the form of a split one- piece annular ring comprising interfitting end configurations. According to the invention, the above described wherein the split collet comprises a distal lead-in chamfered surface. According to the invention, the above-described split collet comprises an inner bore and a radially extending surface. According to the invention, the above-described arrangement further comprises: a catheter adapter having a proximal end; a catheter mounted within the catheter adapter; and an external coupling housing comprising a proximal end, the external coupling housing being received within the proximal end of the catheter adapter; and wherein the needle shield is received within the proximal end of the catheter adapter. According to a further aspect of the invention, there is provided a method of making a needle safe, the needle comprising a longitudinal axis comprising a sharp distal tip, a shank portion, and a needle feature defining at least one localized area along the shank of increased outer diameter, the method comprising: providing a needle shield defining a longitudinal central axis and comprising a proximal opening having a diameter great enough to permit passage of the needle shank therethrough, but small enough to prevent the needle feature from passing therethrough, and a distal opening having a diameter great enough to allow both the needle shank and needle feature to pass therethrough, and an inner shoulder surface; providing a biasing member adapted to exert a generally downward biasing force upon the needle; drawing the needle completely through the distal needle passage; applying a downward biasing force on the needle with the biasing member causing the needle to become angled downwardly such that the central axis and the needle axis diverge, and forcing the sharp tip of the needle out of registry with the distal needle passage thereby trapping the needle within the needle shield by the inner shoulder surface. According to yet another aspect of the invention, there is provided a method of making a needle safe, the needle comprising a longitudinal axis comprising a sharp distal tip, a shank portion, and a needle feature defining at least one localized area along the shank of increased outer diameter, the method comprising: providing a needle shield defining a longitudinal central axis, a proximal through-hole opening and a distal through-hole opening, and comprising a pocket formed therein comprising an inclined surface; locating a split collet within the pocket having a variable inner bore; and disposing a biasing element within the pocket for biasing the split collet toward the inclined surface of the pocket; drawing the needle toward the interior of the needle shield such that the needle feature comes into contact with the split collet; compressing the biasing element such that the split collet no longer contacts the inclined pocket surface and the inner bore of the split collet is expanded, thereby allowing passage of the needle feature through the split collet with a predetermined degree of interference therewith; further drawing the needle such that the needle feature passes out of the inner bore of the split collet thereby removing the aforementioned compression of the biasing element, which causes the split collet to once again be biased against the inclined surface, and also causing the inner bore of the split collet to constrict such that it is once again smaller in diameter than the distal through-hole opening as well as the outer diameter of the needle feature, thereby preventing the sharp distal tip of the needle from exiting the needle shield housing. Bnef Description Of The Drawings The preferred embodiments are illustrated in the drawings in which like reference numerals refer to the like elements. FIG. 1 is a cross-sectional exploded view of an assembly constructed according to the principles of a first embodiment of the present invention. FIG. 2 is cross-sectional view of the assembly of FIG. 1, shown in a partially-assembled state. FIG. 3 is a cross-sectional view of the arrangement of FIG. 1, shown in a fully assembled condition and with a needle located in a first position. FIG. 4 is a cross-sectional view of the arrangement of FIG. 3, wherein the needle is shown in a second, withdrawn position. FIG. 5 is a cross-sectional view of the arrangement of FIG. 4, wherein the arrangement is in a partially disassembled condition. FIG. 6 is a cross-sectional view of a second embodiment of a needle capture mechanism and arrangement formed according to the principles of the present invention, in a first position or state. FIG. 7 A is a top view of one of the components of the arrangements of FIG. 6 formed according to a first alternative construction. FIG. 7B is a top view of a component of the arrangement of FIG. 6 having a second alternative construction. FIG. 8 is a cross-sectional view of the arrangement of FIG. 6 shown in a second position or state. FIG. 9 is a cross-sectional view of the arrangement of FIG. 6 shown in a third position or state. Modes For Carrying Out The Invention The principles of the present invention will now be further described by the following discussion of certain illustrative embodiments thereof and by reference to the foregoing drawing figures. As used herein, the term "proximal" refers to a location on the catheter and introducer needle assembly with needle shield of this invention that, during normal use, is closest to the clinician using the device and farthest from the patient in connection with whom the device is used. Conversely, the term "distal" refers to a location on the catheter and introducer needle assembly of this invention that, during normal use, is farthest from the clinician using the device and closest to the patient in connection with whom the device is used. As used herein, the term "top," "up" or "upwardly" refers to a location on the catheter and introducer needle assembly with needle shield of this invention that, during normal use, is radially away from the longitudinal axis of the device and away from the patient's skin. Conversely, as used herein, the term "bottom," "down" or "downwardly" refers to a location on the catheter and introducer needle assembly of this invention that, during normal use, is radially away from the longitudinal axis of the device and toward the patient's skm. As used herem, the term "in" or "inwardly" refers to a location with respect to the catheter and introducer needle assembly with needle shield of this invention that, during normal use, is toward the inside of the device. Conversely, as used herein, the term "out" or "outwardly" refers to a location with respect to the catheter and introducer needle assembly of this invention that, during normal use, is toward the outside of the device. As used herein, the term "needle" refers to a member having at least one relatively sharp end. The member may be either hollow or solid in cross-section. The member may have any number of suitable dimensions and/or geometries. The present invention is described herein using the same reference numbers for like elements in the different embodiments. Although this invention is described herein in connection with various devices and assemblies, it is to be understood that this invention is usable alone and is also applicable to other devices. For example, this invention is applicable to standard IV catheters and extended dwell catheters requiring the needle to be connected to the needle hub by a stylet, as well as other medical devices where it is desirable for a needle to be shielded after use such as anesthesia needles, epidural needles, catheter introducers and hypodermic syringes. A first illustrative embodiment of the present invention is depicted in FIGS. 1-5. As best illustrated in FIGS. 1-3, this embodiment can be identified generally as an over-the-needle catheter assembly 10. The assembly 10 defines a central longitudinal axis AC. The catheter assembly 10 includes a catheter 12 mounted within a catheter adapter 14. The proximal end 15 of the catheter adapter 14 receives an external coupling housing member 16 therein. A needle shield 18 is also mcluded in the catheter assembly 10. The needle shield 18 is received within the proximal end 17 of the external couplmg housing 16. The needle shield 18 is optionally provided with a retention means 30, which acts to secure the needle shield 18 within the external couplmg housing 16. According to the illustrated embodiment, the retention means 30 is in the form of a folded tab cut out of a sidewall of the needle shield 18 It is within the scope of the present invention that alternative constructions for retaining the needle shield 18 are encompassed within the scope of the present invention. For example, the needle shield 18 may be provided with one or more areas of increased outer diameter along the periphery thereof (not shown), which would also act to secure the needle shield 18 within the external coupling housing 16. Moreover, various adhesives and/or mechanical fasteners and/or frangible links may be utilized as the retention means to accomplish the same functionality. As illustrated, for example, in FIG. 3, the assembly 10 further includes a needle 20 concentrically disposed within the catheter 12. The needle 20 defines a longitudinal axis AN extendmg therethrough. According to the illustrated embodiment, the needle 20 comprises a shank 22 having a needle feature 24 provided thereon. The needle feature 24 provides the shank 22, on at least a portion thereof, with a localized area of increased outer diameter. In this regard, numerous physical constructions for providing this area of increased outer diameter are envisioned. For example, the needle feature 24 may comprise a crimp in the shank 22 of the needle 20, thereby defining a localized area of increased outer diameter, relative to adjacent sections of the needle shank 22. Alternatively, the needle feature 24 may comprise a ferrule. The ferrule can comprise either a separate member fixably attached to the shank 22 or an integral portion of mcreased diameter such that the shank and ferrule comprise a one-piece monolithic part. The term "ferrule"' as utilized herein is intended to encompass each of the above-described alternative constructions. The above-described components of the assembly 10 can be formed from any suitable material or combinations of different materials. For example, the catheter adapter 14 and the external coupling housing 16 can be made of similar or different thermoplastic materials. Suitable materials mclude polyamide, polytetrafluoroethylene, fluonnated ethylene propylene, polyurethane and the like. The needle shield 18 can also be formed of any suitable material, such as a metallic material or any of the above-described thermoplastic materials The assembly 10 further comprises a biasing member for exerting a biasing force on the needle 20. When constructed of a metallic material, it is convenient that the needle shield 18 be provided with an integral biasing member 38. According to the illustrated embodiment, the biasing member 38 includes a finger-spring element, which is formed by cutting and folding the side-wall of the needle shield 18. It should be understood, however, that many different biasing elements are envisioned by the present invention. Any suitable mechanical spring member could be substituted. Alternatively, a metal or plastic clip, elastomenc and/or magnetic biasing elements are possible. Operation of the illustrated embodiment of the present invention will now be described by reference to FIGS. 3-5. As illustrated in FIG. 3, the shank 22 of the needle 20 is disposed within the catheter 12, extends therethrough and passes through the coupling housing needle passage 32. The shank 22 continues and extends to both the proximal and distal openings 34 and 36, respectively, of the needle shield 18 (see, e.g., FIG 1). As the needle 20 extends through the needle shield 18, the biasing element 38 is in contact with the shank 22 and exerts a generally downward biasing force thereon. In the state illustrated in FIG. 3, it is evident that the central axis AC and the longitudinal axis of the needle AN substantially coincide. As illustrated in FIG. 4, as the needle 20 is withdrawn in the proximal direction, the shank 22 is withdrawn from the catheter 12 and eventually passes completely through the coupling housing needle passage 32, as well as the distal needle passage 36 of the needle shield 18. In this state, the sharp tip 26 of the needle 20 is located entirely within the confines of the needle shield 18. Once the needle 20 has been completely withdrawn through the couplmg housing needle passage 32 and the distal needle passage 36, the downward biasing force of the biasing element 38 causes the needle to become angled downwardly such that the central axis AC and the needle axis AN diverge and no longer coincide. As illustrated in FIG. 4, the sharp tip 26 of the needle 20 is forced out of registry with the distal needle passage 36 and the coupling housing needle passage 32 by the downward force of the biasing element 38. The sharp tip 26 of the needle 20 is trapped within the needle shield 18 by inner shoulder surface 40 thereby preventing unwanted movement of the needle 20 in the distal direction. Moreover, unwanted movement of the needle 20 in the proximal direction is also prevented by virtue of the fact that the needle feature 24, having at least a localized area of increased outer diameter, prevents further passage of the needle shank 22 through the proximal needle passage 34 of the needle shield 18. In other words, the inner diameter of the proximal needle passage 34 is smaller then the outer diameter of the needle feature 24. Thus, it is evident that the needle 20 has been made safe within the needle shield 18. As illustrated in FIG. 5, the external coupling housing 16, with the needle shield 18 and captured needle 20 contained therein, can be jointly removed from the catheter adapter 14 for safe and convenient disposal. Alternatively, the needle shield 18 may be separable from the external coupling housing. While the principles of this embodiment of the present invention have been described by reference to a specific illustrated embodiment, it should be understood that the scope of this embodiment of the present invention is not confined .thereto. Namely, the needle capture mechanism of this embodiment of the present invention can be generally described as follows. A needle shield is constructed to permit a needle to be at least partially drawn therethrough. When the sharp tip of the needle has been drawn completely within the confines of the needle shield, a downwardly acting biasing force acts to push the needle in a direction that causes a change in the angular orientation of its longitudinal axis. This change in the angular orientation of the longitudinal axis of the needle, coupled with the physical construction of the needle shield, prevents the sharp tip of the needle from exiting one end of the needle shield. In addition, the needle is provided with a feature that, in conjunction with the construction of the needle shield, prevents further undesired movement of the needle out of the opposing end of the needle shield. A second embodiment of a needle capture mechanism and arrangement formed according to the principles of the present mvention is depicted in FIGS. 6-9. As illustrated, for example, in FIG. 6, a needle shield arrangement 100 comprises a needle shield housing 102 having a proximal through-hole opening 104, a distal through-hole opening 106, and defining a longitudinal central axis AC. A needle shield housing 102 is formed with a pocket 108 that is defined, at least in part, by an inclined surface 110, a radially-extending pocket surface 112, and an interconnecting longitudinal surface 114. The needle shield housing 102 can be formed from any suitable material, such as a metal or a thermoplastic material of the type identified in the description of the first embodiment. A needle 116 is received through the proximal through-hole opening 104, as well as the distal through-hole opening 106. The needle 116 comprises a shank portion 118, as well as a needle feature 120 disposed thereon. The needle feature 120 provides at least a localized area of mcreased outer diameter. Numerous constructions are envisioned as being capable of providing this feature. For example, the needle feature 120 may comprise a crimp in the wall of the needle, thereby providing a localized area of mcreased outer diameter. Alternatively, the needle feature 120 may comprise a ferrule. As used herein, the term "ferrule" refers to a separate member fixably attached to the shank portion 118 of the needle 116, thereby providing at least a localized area of increased outer diameter. In addition, the term "ferrule" is intended to encompass a construction wherein the ferrule comprises an integral part of the shank 118, thereby defining a one-piece monolithic construction composed of both the needle feature 120 and the shank portion 118. The needle 116 further comprises a sharp distal tip 122. The assembly 100 further comprises a split collet 124 disposed within the'pocket 108 of the needle shield housing 102. The split collet 124 is generally in the form of an annular ring member. According to the illustrated embodiment, the split collet 124 comprises a distal lead-in chamfered surface 126, an inner bore 128, and a proximal radially-extending surface 130. The split collet can be formed from any suitable material, such as a metal or a thermoplastic of the type identified in connection with the description of the first embodiment A biasing element 132 is also located within the pocket 108 and is disposed generally between the proximal pocket surface 112 and the proximal radially-extending surface 130 of the split collet 124. The biasing element 132 can comprise many different types of elements According to the illustrated embodiment, the biasing element 132 is schematically illustrated as a mechanical spring member. Further constructions are comprehended. For example, the biasing element 132 may comprise a metal or plastic clip, an elastomeric element or a magnetic element. As noted above, the collet 124 has a split annular configuration. This split annular configuration allows for a predetermined degree of expansion and contraction of the inner diameter, as defined by the inner bore 128. As illustrated in FIGS. 7A-7B, the split collet 124 can be in the form of a single piece ring or multiple arcuate segments. FIG. 7A is illustrative of a split collet 124' in the form of a plurality of arcuate segments 51 and S2. While this embodiment of the split collet 124' is shown as comprising two arcuate segments, it should be understood that it is possible to construct the split collet from three or more such arcuate segments. As further illustrated in FIG. 7A, each of the arcuate segments SI, 52 has interfitting ends E'l and E'2, respectively, which permit the aforementioned expansion and contraction of the inner diameter of the split collet 124. In the illustrated embodiment, these mterfitting ends E' 1 and E'2 are in the form of a staircase-type geometry. It is envisioned, however, that numerous other geometries may be provided to the interfitting ends, so long as the desired expansion and contraction of the inner diameter of the split collet 124 can be " accommodated. FIG. 7B is illustrative of an alternative construction of the split collet which comprises a single piece split ring 124". The one-piece ring 124" has a split end configuration SE. According to the illustrated example, the split end SE has a first and second mating end configuration E' 1 and E"2. Once again, the end constructions E" 1 and E"2 are shown in the form of a staircase-type geometry, which permits the desired expansion and contraction of the inner diameter of the split collet 124". As noted above, however, numerous other geometrical configurations are contemplated, so long as they accommodate the desired expansion and contraction of the inner diameter of the split collet 124". The operation of this embodiment of the present invention will now be described by reference to drawings FIGS. 6, 8 and 9. As illustrated in FIG. 6, in a state in which the sharp distal tip 122 of the needle 116 is disposed entirely outside of the needle shield housing 102, the split collet 124 is urged in a forward, or distal, direction under the action of the biasing element 132. As the split collet 124 is forced against the inclined surface 110 under the action of the biasing element 132, the split collet 124 is radially compressed; thereby reducing the inner diameter as defined by the inner bore 128. As illustrated in FIG. 6, in this state, the inner bore 128 defines a diameter smaller than the distal through-hole opening 106, and is smaller than the outer diameter of the needle feature 120. FIG. 8 illustrates the arrangement 100 in a state in which the needle 116 has been partially drawn into the needle shield housing 102 in the proximal direction. As the needle 116 is withdrawn in the proximal direction, the needle feature 120 comes into contact with the chamfered lead-in surface 126 of the split collet 124. This contact causes compression of the biasing element 132 such that the split collet no longer contacts the inclined pocket surface 110. In the state illustrated in FIG. 8, the inner diameter of the split collet 124, as defined by the inner bore 128, is permitted to expand. This allows for passage of the needle feature 120 through the inner bore 128 with a degree of interference therewith. As illustrated in FIG. 9, as the sharp distal tip 122 of the needle 116 is completely withdrawn into the needle shield housing 102, the needle feature 120 passes out of the inner bore 128 of the split collet 124, thereby removing the aforementioned compression of the biasing element 132, which causes the split collet 124 to be once again urged against the inclined pocket surface 110, thereby contracting the inner diameter as defined by the inner bore 128. The inner bore 128 is once again smaller in diameter than the outer diameter of the needle feature 120. In addition, the diameter defined by the bore of the proximal through-hole opening 104 is smaller than the outer diameter of the needle feature 120. Given these relative dimensions, it is evident that the needle feature 120 is trapped between the proximal pocket surface 112 and the proximal radially extending surface 130. Thus, the needle 116 trapped in a positioned such that the sharp distal tip 122 is located within the needle shield housing 102. While this invention is satisfied by embodiments in many different forms, as described in detail in connection with preferred embodiments of the invention, it is understood that the present disclosure is to be considered as exemplary of the principles of the invention and is not intended to limit the invention to the specific embodiments illustrated and described herein. Numerous variations may be made by persons skilled in the art without departure from the spirit of the invention. The scope of the invention will be measured by the appended claims and their equivalents. We claim: 1. A needle safety arrangement (100) comprising: a needle (116) defining a longitudinal needle axis (AN) having a sharp distal tip (112), a shank portion (118), and a needle feature (120) defining at least one localized area along the shank of increased outer diameter; a needle shield (102) defining a longitudinal central axis (Ac), a proximal through-hole opening (104) and a distal through-hole opening (106), the needle shield comprising a pocket (108) formed therein comprising an inclined surface (110); characterized in that the needle safety arrangement (100) comprises: a split collet (124) disposed within the pocket (108), the split collet (124) having a variable inner bore (128); and a biasing element (132) disposed within the pocket (108) for biasing the split collet (124) toward the inclined surface (110) of the pocket; wherein the arrangement (100) is constructed such that as the needle (116) is drawn in toward the interior of the needle shield (102), the needle feature (120) comes into contact with the split collet (124), which causes compression of the biasing element (132) such that the split collet (124) no longer contacts the inclined pocket surface (110) and the inner bore (128) of the split collet (124) is expanded, thereby allowing passage of the needle feature (120) through the split collet (124) with a predetermined degree of interference therewith, and further as the sharp distal tip (112) of the needle (116) is completely withdrawn into the needle shield housing (102), the needle feature (120) passes out of the inner bore (128) of the split collet (124) thereby removing the aforementioned compression of the biasing element (132), which causes the split collet (124) to once again be biased against the inclined surface (110), and also causing the inner bore (128) of the split collet (124) to constrict such that it is once again smaller in diameter than the distal through-hole opening (106) as well as the outer diameter of the needle feature (120), thereby preventing the sharp distal tip (112) of the needle (116) from exiting the needle shield housing (102). 2. The arrangement (100) as claimed in claim 1, wherein at least one of the needle shield (102) and split collet (124) is formed from a polyamide, a polytetrafluoroethylene, a fluorinated ethylene propylene, a polyurethane, or a metallic material. 3. The arrangement (100) as claimed in claim 1, wherein the needle feature (120) comprises a crimp or a ferrule. 4. The arrangement (100) as claimed in claim 1, wherein the biasing element (132) comprises one or more of: a mechanical spring, a metal or plastic clip, an elastomeric element, or magnetic force. 5 The arrangement (100) as claimed in claim 1, wherein the split collet (124) is in the form of an annular ring comprising a plurality of arcuate segments having interfitting end configurations. 6. The arrangement (100) as claimed in claim 1, wherein the split collet (124) is in the form of a split one-piece annular ring comprising interfitting end configurations. 7. The arrangement (100) as claimed in claim 1, wherein the split collet (124) comprises a distal lead-in chamfered surface (126). 8 The arrangement (100) as claimed in claim 1, wherein the split collet (124) comprises an inner bore (128) and a radially extending surface (130). 9 The arrangement (100) as claimed in claim 1, comprising: a catheter adapter (14) comprising a proximal end (15); a catheter (12) mounted within the catheter adapter (14); and an external coupling housing (16) comprising a proximal end (17), the external coupling housing (16) being received within the proximal end (15) of the catheter adapter (14); wherein the needle shield (102) is received within the proximal end (15) of the catheter adapter (14). 10. A method of making a needle safety arrangement, the needle comprising a longitudinal axis comprising a sharp distal tip, a shank portion, and a needle feature defining at least one localized area along the shank of increased outer diameter, the method comprising: providing a needle shield defining a longitudinal central axis, a proximal through-hole opening and a distal through-hole opening, and comprising a pocket formed therein comprising an inclined surface; locating a split collet within the pocket having a variable inner bore; and disposing a biasing element within the pocket for biasing the split collet toward the inclined surface of the pocket; wherein the split collet is located within the pocket such that: in drawing the needle toward the interior of the needle shield, the needle feature comes into contact with the split collet, resulting in compression of the biasing element such that the split collet no longer contacts the inclined pocket surface and the inner bore of the split collet is expanded, thereby allowing passage of the needle feature through the split collet with a predetermined degree of interference therewith; and in drawing the needle further toward interior of the needle shield, the needle feature passes out of the inner bore of the split collet thereby removing the aforementioned compression of the biasing element, which causes the split collet to once again be biased against the inclined surface, and also causes the inner bore of the split collet to constrict such that it is once again smaller in diameter than the distal through-hole opening as well as the outer diameter of the needle feature, thereby preventing the sharp distal tip of the needle from exiting the needle shield housing NEEDLE SAFETY ARRANGEMENT AND A METHOD OF MAKING THE SAME ABSTRACT Needle capture mechanisms and arrangements are provided. One such arrangement includes a needle defining a longitudinal needle axis having a sharp distal tip, a shank portion, and a needle feature defining at least one localized area along the shank of increased outer diameter; a needle shield; and a biasing member adapted to exert a generally downward biasing force upon the needle. Another such arrangement includes a needle defining a longitudinal needle axis having a sharp distal tip, a shank portion, and a needle feature defining at least one localized area along the shank of increased outer diameter; a needle shield, the needle shield comprising a pocket formed therein having an inclined surface; a split collet disposed within the pocket, the split collet having a variable inner bore; and a biasing element disposed within the pocket for biasing the split collet toward the inclined surface of the pocket.

Full Text

NEEDLE CAPTURE MECHANISMS
This application claims priority to U.S. Provisional Application Serial No. 60/633,413
filed December 7, 2004, which is incorporated herein by reference in its entirety.
Technical Field
The subject invention relates to mechanisms that will effectively and safely capture a
needle or other sharp object, thereby placing the needle or other sharp object in a state that
makes accidental contact therewith unlikely or impossible.
Background Art
In the following discussion, certain articles and methods will be described for
background and introductory purposes. Nothing contained herein is to be construed as an
"admission" of prior art. Applicants expressly reserve the right to demonstrate, where
appropriate, that the articles and methods referenced herein do not constitute prior art under the
applicable statutory provisions.
In recent years, there has been great concern over the contamination of clinicians with a
patient's blood and a recognition that blood contaminated sharps must be disposed of to avoid an
accidental needle stick. This concern has arisen because of the advent of currently incurable and
fatal diseases, such as Acquired Immune Deficiency Syndrome ("AIDS"), which can be
transmitted by the exchange of body fluids from an infected person to another person Thus,
contact with the body fluids of an AIDS infected person must be avoided. As noted above, if a
needle has been inserted into an AIDS infected person, the needle, via its sharp distal tip, is a
vehicle for the transmission of the disease. Although clinicians are aware of the need to
properly handle blood contaminated sharps, unfortunately, in certain medical environments such
as emergency situations or as a result of inattention or neglect, needle sticks with a blood
contaminated sharp still occur.
As a result of the problem of accidental needle sticks by blood contaminated sharps,
various needle shields have been developed. Such devices are disclosed in, for example, U.S.
Patent Nos. 5,601,536 and 4,994,041.
Devices such as catheters, catheter introducers and guidewire introducers are all
examples of the types of devices that can incorporate a needle or other sharp object therein.
Catheters, particularly intravascualar (IV) catheters, are used for infusing fluid, such as normal
saline solution, various medicaments and total paternal nutrition, into a patent, withdrawing

blood from a patient or monitoring various parameters of the patient's vascular system.
Peripheral IV catheters tend to be relatively short and, typically, are on the order of about two
inches or less in length. The most common type o IV catheter is an over-the-needle peripheral
IV catheter. As its name implies, an over-the-needle catheter is mounted over an introducer
needle having a sharp distal tip. At least the distal portion of the catheter tightly engages the
outer surface of the needle to prevent peelback of the catheter, thereby facilitating insertion of
the catheter into the blood vessel. The catheter and the introducer needle are assembled so that
the distal tip of the introducer needle extends beyond the distal tip of the catheter, with the bevel
of the needle facing up away from the patient's skin.
The catheter and introducer needle assembly is inserted at a shallow angle through the
patient's skin into a blood vessel. There are many techniques for inserting such a catheter and
introducer needle assembly into a patient. In one insertion technique, the introducer needle and
catheter are inserted completely into the blood vessel together. In another technique, the
introducer needle is partially withdrawn into the catheter after the initial insertion into the blood
vessel. The catheter is then threaded over the needle and inserted completely into the blood
vessel.
To verify proper placement of the catheter in the blood vessel, the clinician confirms that
there is flashback of blood in a flashback chamber. The flashback chamber is typically formed
as part of the needle hub. Alternatively, where the introducer needle includes a notch, i.e., a
hole or opening in the sidewall of the introducer needle, flashback of blood can be observed in
the annular space between the introducer needle and the catheter, in the catheter adapter and,
where the catheter is an integrated catheter, in an extension tube extending from a side arm
formed in the catheter adapter. Once proper placement of the catheter into the blood vessel is
confirmed, the clinician applies pressure to the blood vessel by pressing down on the patient's
skin over the blood vessel distal to the introducer needle and catheter. This finger pressure
occludes, or at least minimizes, further blood flow through the introducer needle and the
catheter. The clinician then withdraws the introducer needle, leaving the catheter in place, and
attaches an appropriate device to the catheter. Such a device can include a fluid delivery device,
a PRN, a deadender cap or a blood pressure monitoring probe. Once the introducer needle is
withdrawn from the catheter, the introducer needle is a blood contaminated sharp and must be

properly handled.
It would be desirable, in general, to provide a needle capture and shielding arrangement
having an improved capture mechanism. For instance, some conventional needle capture
mechanisms can require a relatively large amount of space within the apparatus into which it is
incorporated. Moreover, some conventional needle capture mechanisms require the user to
undertake specific steps or actions to activate the capture mechanism; such steps or measures are
often not intuitive. Thus there is a need to provide relatively compact needle capture
mechanisms that are easy to use.
Disclosure Of The Invention
Therefore, according to certain embodiments, the present invention comprises a device
or method that provides one or more of the following features and advantages: a needle capture
device and arrangement that is compact, simple and easy to use, requires no special features or
techniques to be operative, and has a relatively low cost.
According to one aspect of the present invention, there is provided an arrangement
comprising: a needle defining a longitudinal needle axis having a sharp distal tip, a shank
portion, and a needle feature defining at least one localized area along the shank of increased
outer diameter; a needle shield defining a longitudinal central axis, the needle shield comprising
a proximal opening having a diameter great enough to permit passage of the needle shank
therethrough, but small enough to prevent the needle feature from passing therethrough, a distal
opening having a diameter great enough to allow both the needle shank and needle feature to
pass therethrough, and an inner shoulder surface; and a biasing member adapted to exert a
generally downward biasing force upon the needle; wherein the arrangement is constructed such
that upon drawing the needle completely through the distal needle passage, the downward
biasing force of the biasing element causes the needle to become angled downwardly such that
the central axis and the needle axis diverge, and the sharp tip of the needle is forced out of
registry with the distal needle passage and is trapped within the needle shield by the inner
shoulder surface.

According to the invention, the above-described arrangement further comprises: a
catheter adapter having a proximal end; a catheter mounted within the catheter adapter; and an
external coupling housing comprising a proximal end, the external coupling housing being
received within the proximal end of the catheter adapter; and wherein the needle shield is
received within the proximal end of the catheter adapter.
According to another aspect of the present invention, the above-described needle shield
is retained within the external coupling housing by one or more of the following: a folded tab,
one or more areas of increased outer diameter along the external periphery of the needle shield,
an adhesive, a frangible link and a mechanical fastener.
According to the invention, the above-described biasing member comprises one or more
of: a finger spring in the form of a folded tab cut from the sidewall of the needle shield, a
mechanical spring; an elastomeric spring; a pneumatic element; and an electromechanical
element.
According to the invention, the above-described catheter adapter and external coupling
housing are formed from a thermoplastic material, such as a polyamide, a
polytetrafluoroethylene, a fluonnated ethylene propylene, a polyurethane, or a metallic material.
According to the invention, the above-described needle feature comprises a crimp or a
ferrule.
According to the invention, the above-described arrangement is constructed such that the
needle shield, having a needle captured therein is separable from one or more of the catheter
adapter and the external coupling housing.
According to another aspect, the present invention provides an arrangement comprising,
a needle defining a longitudinal needle axis having a sharp distal tip, a shank portion, and a
needle feature defining at least one localized area along the shank of increased outer diameter; a
needle shield defining a longitudinal central axis, a proximal through-hole opening and a distal
through-hole opening, the needle shield comprising a pocket formed therein having an inclined
surface; a split collet disposed within the pocket, the split collet having a variable inner bore;
and a biasing element disposed within the pocket for biasing the split collet toward the inclined
surface of the pocket; wherein the arrangement is constructed such that as the needle is drawn in
toward the interior of the needle shield, the needle feature comes into contact with the split

collet, which causes compression of the biasing element such that the split collet no longer
contacts the inclined pocket surface and the inner bore of the split collet is expanded, thereby
allowing passage of the needle feature through the split collet with a predetermined degree of
interference therewith, and further as the sharp distal tip of the needle is completely withdrawn
into the needle shield housing, the needle feature passes out of the inner bore of the split collet,
thereby removing the aforementioned compression of the biasing element, which causes the split
collet to once again be biased against the mclined surface, this also causes the inner bore of the
spht collet to constrict such that it is once again smaller in diameter than the distal through-hole
opening, as well as the outer diameter of the needle feature, thereby preventing the sharp distal
tip of the needle from exiting the needle shield housing
According to the invention, the above-described needle shield and/or split collet is
formed from a thermoplastic material, such as a polyamide, a polytetrafluoroethylene, a
fluorinated ethylene propylene, a polyurethane, or a metallic material.
According to the invention, the above-described needle feature comprises a crimp or a
ferrule.
According to the invention, the above-described biasing element comprises one or more
of: a mechanical spring, a metal or plastic clip, an elastomeric element, or magnetic force.
According to the invention, the above-described split collet is in the form of an annular
ring comprising a plurality of arcuate segments having interfitting end configurations.
According to the invention, the above-described split collet is in the form of a split one-
piece annular ring comprising interfitting end configurations.
According to the invention, the above described wherein the split collet comprises a
distal lead-in chamfered surface.
According to the invention, the above-described split collet comprises an inner bore and
a radially extending surface.
According to the invention, the above-described arrangement further comprises: a
catheter adapter having a proximal end; a catheter mounted within the catheter adapter; and an
external coupling housing comprising a proximal end, the external coupling housing being
received within the proximal end of the catheter adapter; and wherein the needle shield is
received within the proximal end of the catheter adapter.

According to a further aspect of the invention, there is provided a method of making a
needle safe, the needle comprising a longitudinal axis comprising a sharp distal tip, a shank
portion, and a needle feature defining at least one localized area along the shank of increased
outer diameter, the method comprising: providing a needle shield defining a longitudinal central
axis and comprising a proximal opening having a diameter great enough to permit passage of the
needle shank therethrough, but small enough to prevent the needle feature from passing
therethrough, and a distal opening having a diameter great enough to allow both the needle
shank and needle feature to pass therethrough, and an inner shoulder surface; providing a biasing
member adapted to exert a generally downward biasing force upon the needle; drawing the
needle completely through the distal needle passage; applying a downward biasing force on the
needle with the biasing member causing the needle to become angled downwardly such that the
central axis and the needle axis diverge, and forcing the sharp tip of the needle out of registry
with the distal needle passage thereby trapping the needle within the needle shield by the inner
shoulder surface.
According to yet another aspect of the invention, there is provided a method of making a
needle safe, the needle comprising a longitudinal axis comprising a sharp distal tip, a shank
portion, and a needle feature defining at least one localized area along the shank of increased
outer diameter, the method comprising: providing a needle shield defining a longitudinal central
axis, a proximal through-hole opening and a distal through-hole opening, and comprising a
pocket formed therein comprising an inclined surface; locating a split collet within the pocket
having a variable inner bore; and disposing a biasing element within the pocket for biasing the
split collet toward the inclined surface of the pocket; drawing the needle toward the interior of
the needle shield such that the needle feature comes into contact with the split collet;
compressing the biasing element such that the split collet no longer contacts the inclined pocket
surface and the inner bore of the split collet is expanded, thereby allowing passage of the needle
feature through the split collet with a predetermined degree of interference therewith; further
drawing the needle such that the needle feature passes out of the inner bore of the split collet
thereby removing the aforementioned compression of the biasing element, which causes the split
collet to once again be biased against the inclined surface, and also causing the inner bore of the
split collet to constrict such that it is once again smaller in diameter than the distal through-hole

opening as well as the outer diameter of the needle feature, thereby preventing the sharp distal
tip of the needle from exiting the needle shield housing.
Bnef Description Of The Drawings
The preferred embodiments are illustrated in the drawings in which like reference
numerals refer to the like elements.
FIG. 1 is a cross-sectional exploded view of an assembly constructed according to the
principles of a first embodiment of the present invention.
FIG. 2 is cross-sectional view of the assembly of FIG. 1, shown in a partially-assembled
state.
FIG. 3 is a cross-sectional view of the arrangement of FIG. 1, shown in a fully assembled
condition and with a needle located in a first position.
FIG. 4 is a cross-sectional view of the arrangement of FIG. 3, wherein the needle is
shown in a second, withdrawn position.
FIG. 5 is a cross-sectional view of the arrangement of FIG. 4, wherein the arrangement is
in a partially disassembled condition.
FIG. 6 is a cross-sectional view of a second embodiment of a needle capture mechanism
and arrangement formed according to the principles of the present invention, in a first position
or state.
FIG. 7 A is a top view of one of the components of the arrangements of FIG. 6 formed
according to a first alternative construction.
FIG. 7B is a top view of a component of the arrangement of FIG. 6 having a second
alternative construction.

FIG. 8 is a cross-sectional view of the arrangement of FIG. 6 shown in a second position
or state.
FIG. 9 is a cross-sectional view of the arrangement of FIG. 6 shown in a third position or
state.
Modes For Carrying Out The Invention
The principles of the present invention will now be further described by the following
discussion of certain illustrative embodiments thereof and by reference to the foregoing drawing
figures.
As used herein, the term "proximal" refers to a location on the catheter and introducer
needle assembly with needle shield of this invention that, during normal use, is closest to the
clinician using the device and farthest from the patient in connection with whom the device is
used. Conversely, the term "distal" refers to a location on the catheter and introducer needle
assembly of this invention that, during normal use, is farthest from the clinician using the device
and closest to the patient in connection with whom the device is used.
As used herein, the term "top," "up" or "upwardly" refers to a location on the catheter
and introducer needle assembly with needle shield of this invention that, during normal use, is
radially away from the longitudinal axis of the device and away from the patient's skin.
Conversely, as used herein, the term "bottom," "down" or "downwardly" refers to a location on
the catheter and introducer needle assembly of this invention that, during normal use, is radially
away from the longitudinal axis of the device and toward the patient's skm.
As used herem, the term "in" or "inwardly" refers to a location with respect to the
catheter and introducer needle assembly with needle shield of this invention that, during normal
use, is toward the inside of the device. Conversely, as used herein, the term "out" or
"outwardly" refers to a location with respect to the catheter and introducer needle assembly of
this invention that, during normal use, is toward the outside of the device.

As used herein, the term "needle" refers to a member having at least one relatively sharp
end. The member may be either hollow or solid in cross-section. The member may have any
number of suitable dimensions and/or geometries.
The present invention is described herein using the same reference numbers for like
elements in the different embodiments. Although this invention is described herein in
connection with various devices and assemblies, it is to be understood that this invention is
usable alone and is also applicable to other devices. For example, this invention is applicable to
standard IV catheters and extended dwell catheters requiring the needle to be connected to the
needle hub by a stylet, as well as other medical devices where it is desirable for a needle to be
shielded after use such as anesthesia needles, epidural needles, catheter introducers and
hypodermic syringes.
A first illustrative embodiment of the present invention is depicted in FIGS. 1-5. As best
illustrated in FIGS. 1-3, this embodiment can be identified generally as an over-the-needle
catheter assembly 10. The assembly 10 defines a central longitudinal axis AC. The catheter
assembly 10 includes a catheter 12 mounted within a catheter adapter 14. The proximal end 15
of the catheter adapter 14 receives an external coupling housing member 16 therein.
A needle shield 18 is also mcluded in the catheter assembly 10. The needle shield 18 is
received within the proximal end 17 of the external couplmg housing 16. The needle shield 18
is optionally provided with a retention means 30, which acts to secure the needle shield 18
within the external couplmg housing 16. According to the illustrated embodiment, the retention
means 30 is in the form of a folded tab cut out of a sidewall of the needle shield 18 It is within
the scope of the present invention that alternative constructions for retaining the needle shield 18
are encompassed within the scope of the present invention. For example, the needle shield 18
may be provided with one or more areas of increased outer diameter along the periphery thereof
(not shown), which would also act to secure the needle shield 18 within the external coupling
housing 16. Moreover, various adhesives and/or mechanical fasteners and/or frangible links
may be utilized as the retention means to accomplish the same functionality.

As illustrated, for example, in FIG. 3, the assembly 10 further includes a needle 20
concentrically disposed within the catheter 12. The needle 20 defines a longitudinal axis AN
extendmg therethrough.
According to the illustrated embodiment, the needle 20 comprises a shank 22 having a
needle feature 24 provided thereon. The needle feature 24 provides the shank 22, on at least a
portion thereof, with a localized area of increased outer diameter. In this regard, numerous
physical constructions for providing this area of increased outer diameter are envisioned. For
example, the needle feature 24 may comprise a crimp in the shank 22 of the needle 20, thereby
defining a localized area of increased outer diameter, relative to adjacent sections of the needle
shank 22. Alternatively, the needle feature 24 may comprise a ferrule. The ferrule can comprise
either a separate member fixably attached to the shank 22 or an integral portion of mcreased
diameter such that the shank and ferrule comprise a one-piece monolithic part. The term
"ferrule"' as utilized herein is intended to encompass each of the above-described alternative
constructions.
The above-described components of the assembly 10 can be formed from any suitable
material or combinations of different materials. For example, the catheter adapter 14 and the
external coupling housing 16 can be made of similar or different thermoplastic materials.
Suitable materials mclude polyamide, polytetrafluoroethylene, fluonnated ethylene propylene,
polyurethane and the like. The needle shield 18 can also be formed of any suitable material,
such as a metallic material or any of the above-described thermoplastic materials
The assembly 10 further comprises a biasing member for exerting a biasing force on the
needle 20. When constructed of a metallic material, it is convenient that the needle shield 18 be
provided with an integral biasing member 38. According to the illustrated embodiment, the
biasing member 38 includes a finger-spring element, which is formed by cutting and folding the
side-wall of the needle shield 18. It should be understood, however, that many different biasing
elements are envisioned by the present invention. Any suitable mechanical spring member
could be substituted. Alternatively, a metal or plastic clip, elastomenc and/or magnetic biasing
elements are possible.

Operation of the illustrated embodiment of the present invention will now be described
by reference to FIGS. 3-5. As illustrated in FIG. 3, the shank 22 of the needle 20 is disposed
within the catheter 12, extends therethrough and passes through the coupling housing needle
passage 32. The shank 22 continues and extends to both the proximal and distal openings 34
and 36, respectively, of the needle shield 18 (see, e.g., FIG 1). As the needle 20 extends
through the needle shield 18, the biasing element 38 is in contact with the shank 22 and exerts a
generally downward biasing force thereon. In the state illustrated in FIG. 3, it is evident that the
central axis AC and the longitudinal axis of the needle AN substantially coincide.
As illustrated in FIG. 4, as the needle 20 is withdrawn in the proximal direction, the
shank 22 is withdrawn from the catheter 12 and eventually passes completely through the
coupling housing needle passage 32, as well as the distal needle passage 36 of the needle shield
18. In this state, the sharp tip 26 of the needle 20 is located entirely within the confines of the
needle shield 18. Once the needle 20 has been completely withdrawn through the couplmg
housing needle passage 32 and the distal needle passage 36, the downward biasing force of the
biasing element 38 causes the needle to become angled downwardly such that the central axis
AC and the needle axis AN diverge and no longer coincide. As illustrated in FIG. 4, the sharp
tip 26 of the needle 20 is forced out of registry with the distal needle passage 36 and the
coupling housing needle passage 32 by the downward force of the biasing element 38. The
sharp tip 26 of the needle 20 is trapped within the needle shield 18 by inner shoulder surface 40
thereby preventing unwanted movement of the needle 20 in the distal direction. Moreover,
unwanted movement of the needle 20 in the proximal direction is also prevented by virtue of the
fact that the needle feature 24, having at least a localized area of increased outer diameter,
prevents further passage of the needle shank 22 through the proximal needle passage 34 of the
needle shield 18. In other words, the inner diameter of the proximal needle passage 34 is
smaller then the outer diameter of the needle feature 24. Thus, it is evident that the needle 20
has been made safe within the needle shield 18.
As illustrated in FIG. 5, the external coupling housing 16, with the needle shield 18 and
captured needle 20 contained therein, can be jointly removed from the catheter adapter 14 for
safe and convenient disposal. Alternatively, the needle shield 18 may be separable from the

external coupling housing.
While the principles of this embodiment of the present invention have been described by
reference to a specific illustrated embodiment, it should be understood that the scope of this
embodiment of the present invention is not confined .thereto. Namely, the needle capture
mechanism of this embodiment of the present invention can be generally described as follows.
A needle shield is constructed to permit a needle to be at least partially drawn therethrough.
When the sharp tip of the needle has been drawn completely within the confines of the needle
shield, a downwardly acting biasing force acts to push the needle in a direction that causes a
change in the angular orientation of its longitudinal axis. This change in the angular orientation
of the longitudinal axis of the needle, coupled with the physical construction of the needle
shield, prevents the sharp tip of the needle from exiting one end of the needle shield. In
addition, the needle is provided with a feature that, in conjunction with the construction of the
needle shield, prevents further undesired movement of the needle out of the opposing end of the
needle shield.
A second embodiment of a needle capture mechanism and arrangement formed
according to the principles of the present mvention is depicted in FIGS. 6-9. As illustrated, for
example, in FIG. 6, a needle shield arrangement 100 comprises a needle shield housing 102
having a proximal through-hole opening 104, a distal through-hole opening 106, and defining a
longitudinal central axis AC. A needle shield housing 102 is formed with a pocket 108 that is
defined, at least in part, by an inclined surface 110, a radially-extending pocket surface 112, and
an interconnecting longitudinal surface 114. The needle shield housing 102 can be formed from
any suitable material, such as a metal or a thermoplastic material of the type identified in the
description of the first embodiment.
A needle 116 is received through the proximal through-hole opening 104, as well as the
distal through-hole opening 106. The needle 116 comprises a shank portion 118, as well as a
needle feature 120 disposed thereon. The needle feature 120 provides at least a localized area of
mcreased outer diameter. Numerous constructions are envisioned as being capable of providing
this feature. For example, the needle feature 120 may comprise a crimp in the wall of the
needle, thereby providing a localized area of mcreased outer diameter. Alternatively, the needle

feature 120 may comprise a ferrule. As used herein, the term "ferrule" refers to a separate
member fixably attached to the shank portion 118 of the needle 116, thereby providing at least a
localized area of increased outer diameter. In addition, the term "ferrule" is intended to
encompass a construction wherein the ferrule comprises an integral part of the shank 118,
thereby defining a one-piece monolithic construction composed of both the needle feature 120
and the shank portion 118. The needle 116 further comprises a sharp distal tip 122.
The assembly 100 further comprises a split collet 124 disposed within the'pocket 108 of
the needle shield housing 102. The split collet 124 is generally in the form of an annular ring
member. According to the illustrated embodiment, the split collet 124 comprises a distal lead-in
chamfered surface 126, an inner bore 128, and a proximal radially-extending surface 130. The
split collet can be formed from any suitable material, such as a metal or a thermoplastic of the
type identified in connection with the description of the first embodiment
A biasing element 132 is also located within the pocket 108 and is disposed generally
between the proximal pocket surface 112 and the proximal radially-extending surface 130 of the
split collet 124. The biasing element 132 can comprise many different types of elements
According to the illustrated embodiment, the biasing element 132 is schematically illustrated as
a mechanical spring member. Further constructions are comprehended. For example, the
biasing element 132 may comprise a metal or plastic clip, an elastomeric element or a magnetic
element.
As noted above, the collet 124 has a split annular configuration. This split annular
configuration allows for a predetermined degree of expansion and contraction of the inner
diameter, as defined by the inner bore 128. As illustrated in FIGS. 7A-7B, the split collet 124
can be in the form of a single piece ring or multiple arcuate segments.
FIG. 7A is illustrative of a split collet 124' in the form of a plurality of arcuate segments
51 and S2. While this embodiment of the split collet 124' is shown as comprising two arcuate
segments, it should be understood that it is possible to construct the split collet from three or
more such arcuate segments. As further illustrated in FIG. 7A, each of the arcuate segments SI,
52 has interfitting ends E'l and E'2, respectively, which permit the aforementioned expansion

and contraction of the inner diameter of the split collet 124. In the illustrated embodiment, these
mterfitting ends E' 1 and E'2 are in the form of a staircase-type geometry. It is envisioned,
however, that numerous other geometries may be provided to the interfitting ends, so long as the
desired expansion and contraction of the inner diameter of the split collet 124 can be
" accommodated.
FIG. 7B is illustrative of an alternative construction of the split collet which comprises a
single piece split ring 124". The one-piece ring 124" has a split end configuration SE.
According to the illustrated example, the split end SE has a first and second mating end
configuration E' 1 and E"2. Once again, the end constructions E" 1 and E"2 are shown in the
form of a staircase-type geometry, which permits the desired expansion and contraction of the
inner diameter of the split collet 124". As noted above, however, numerous other geometrical
configurations are contemplated, so long as they accommodate the desired expansion and
contraction of the inner diameter of the split collet 124".
The operation of this embodiment of the present invention will now be described by
reference to drawings FIGS. 6, 8 and 9. As illustrated in FIG. 6, in a state in which the sharp
distal tip 122 of the needle 116 is disposed entirely outside of the needle shield housing 102, the
split collet 124 is urged in a forward, or distal, direction under the action of the biasing element
132. As the split collet 124 is forced against the inclined surface 110 under the action of the
biasing element 132, the split collet 124 is radially compressed; thereby reducing the inner
diameter as defined by the inner bore 128. As illustrated in FIG. 6, in this state, the inner bore
128 defines a diameter smaller than the distal through-hole opening 106, and is smaller than the
outer diameter of the needle feature 120.
FIG. 8 illustrates the arrangement 100 in a state in which the needle 116 has been
partially drawn into the needle shield housing 102 in the proximal direction. As the needle 116
is withdrawn in the proximal direction, the needle feature 120 comes into contact with the
chamfered lead-in surface 126 of the split collet 124. This contact causes compression of the
biasing element 132 such that the split collet no longer contacts the inclined pocket surface 110.
In the state illustrated in FIG. 8, the inner diameter of the split collet 124, as defined by the inner
bore 128, is permitted to expand. This allows for passage of the needle feature 120 through the

inner bore 128 with a degree of interference therewith.
As illustrated in FIG. 9, as the sharp distal tip 122 of the needle 116 is completely
withdrawn into the needle shield housing 102, the needle feature 120 passes out of the inner bore
128 of the split collet 124, thereby removing the aforementioned compression of the biasing
element 132, which causes the split collet 124 to be once again urged against the inclined pocket
surface 110, thereby contracting the inner diameter as defined by the inner bore 128. The inner
bore 128 is once again smaller in diameter than the outer diameter of the needle feature 120. In
addition, the diameter defined by the bore of the proximal through-hole opening 104 is smaller
than the outer diameter of the needle feature 120. Given these relative dimensions, it is evident
that the needle feature 120 is trapped between the proximal pocket surface 112 and the proximal
radially extending surface 130. Thus, the needle 116 trapped in a positioned such that the sharp
distal tip 122 is located within the needle shield housing 102.
While this invention is satisfied by embodiments in many different forms, as described in
detail in connection with preferred embodiments of the invention, it is understood that the
present disclosure is to be considered as exemplary of the principles of the invention and is not
intended to limit the invention to the specific embodiments illustrated and described herein.
Numerous variations may be made by persons skilled in the art without departure from the spirit
of the invention. The scope of the invention will be measured by the appended claims and their
equivalents.

We claim:
1. A needle safety arrangement (100) comprising:
a needle (116) defining a longitudinal needle axis (AN) having a sharp distal tip (112), a
shank portion (118), and a needle feature (120) defining at least one localized area along the shank
of increased outer diameter;
a needle shield (102) defining a longitudinal central axis (Ac), a proximal through-hole
opening (104) and a distal through-hole opening (106), the needle shield comprising a pocket
(108) formed therein comprising an inclined surface (110);
characterized in that the needle safety arrangement (100) comprises:
a split collet (124) disposed within the pocket (108), the split collet (124) having a variable
inner bore (128); and
a biasing element (132) disposed within the pocket (108) for biasing the split collet (124)
toward the inclined surface (110) of the pocket;
wherein the arrangement (100) is constructed such that as the needle (116) is drawn in
toward the interior of the needle shield (102), the needle feature (120) comes into contact with
the split collet (124), which causes compression of the biasing element (132) such that the split
collet (124) no longer contacts the inclined pocket surface (110) and the inner bore (128) of the
split collet (124) is expanded, thereby allowing passage of the needle feature (120) through the
split collet (124) with a predetermined degree of interference therewith, and further as the sharp
distal tip (112) of the needle (116) is completely withdrawn into the needle shield housing (102),
the needle feature (120) passes out of the inner bore (128) of the split collet (124) thereby
removing the aforementioned compression of the biasing element (132), which causes the split
collet (124) to once again be biased against the inclined surface (110), and also causing the inner
bore (128) of the split collet (124) to constrict such that it is once again smaller in diameter than
the distal through-hole opening (106) as well as the outer diameter of the needle feature (120),
thereby preventing the sharp distal tip (112) of the needle (116) from exiting the needle shield
housing (102).

2. The arrangement (100) as claimed in claim 1, wherein at least one of the needle shield (102)
and split collet (124) is formed from a polyamide, a polytetrafluoroethylene, a fluorinated
ethylene propylene, a polyurethane, or a metallic material.
3. The arrangement (100) as claimed in claim 1, wherein the needle feature (120) comprises a
crimp or a ferrule.
4. The arrangement (100) as claimed in claim 1, wherein the biasing element (132) comprises one
or more of: a mechanical spring, a metal or plastic clip, an elastomeric element, or magnetic force.
5 The arrangement (100) as claimed in claim 1, wherein the split collet (124) is in the form of an
annular ring comprising a plurality of arcuate segments having interfitting end configurations.
6. The arrangement (100) as claimed in claim 1, wherein the split collet (124) is in the form of a
split one-piece annular ring comprising interfitting end configurations.
7. The arrangement (100) as claimed in claim 1, wherein the split collet (124) comprises a distal
lead-in chamfered surface (126).
8 The arrangement (100) as claimed in claim 1, wherein the split collet (124) comprises an
inner bore (128) and a radially extending surface (130).
9 The arrangement (100) as claimed in claim 1, comprising:
a catheter adapter (14) comprising a proximal end (15);
a catheter (12) mounted within the catheter adapter (14); and
an external coupling housing (16) comprising a proximal end (17), the external coupling
housing (16) being received within the proximal end (15) of the catheter adapter (14);
wherein the needle shield (102) is received within the proximal end (15) of the catheter
adapter (14).

10. A method of making a needle safety arrangement, the needle comprising a longitudinal
axis comprising a sharp distal tip, a shank portion, and a needle feature defining at least one
localized area along the shank of increased outer diameter, the method comprising:
providing a needle shield defining a longitudinal central axis, a proximal through-hole
opening and a distal through-hole opening, and comprising a pocket formed therein comprising
an inclined surface;
locating a split collet within the pocket having a variable inner bore; and
disposing a biasing element within the pocket for biasing the split collet toward the
inclined surface of the pocket;
wherein the split collet is located within the pocket such that:
in drawing the needle toward the interior of the needle shield, the needle feature comes
into contact with the split collet, resulting in compression of the biasing element such that the
split collet no longer contacts the inclined pocket surface and the inner bore of the split collet is
expanded, thereby allowing passage of the needle feature through the split collet with a
predetermined degree of interference therewith; and
in drawing the needle further toward interior of the needle shield, the needle feature passes
out of the inner bore of the split collet thereby removing the aforementioned compression of the
biasing element, which causes the split collet to once again be biased against the inclined surface,
and also causes the inner bore of the split collet to constrict such that it is once again smaller in
diameter than the distal through-hole opening as well as the outer diameter of the needle feature,
thereby preventing the sharp distal tip of the needle from exiting the needle shield housing

NEEDLE SAFETY ARRANGEMENT AND A METHOD OF
MAKING THE SAME

ABSTRACT

Needle capture mechanisms and arrangements are provided. One such arrangement
includes a needle defining a longitudinal needle axis having a sharp distal tip, a shank
portion, and a needle feature defining at least one localized area along the shank of
increased outer diameter; a needle shield; and a biasing member adapted to exert a
generally downward biasing force upon the needle. Another such arrangement includes
a needle defining a longitudinal needle axis having a sharp distal tip, a shank portion,
and a needle feature defining at least one localized area along the shank of increased
outer diameter; a needle shield, the needle shield comprising a pocket formed therein
having an inclined surface; a split collet disposed within the pocket, the split collet
having a variable inner bore; and a biasing element disposed within the pocket for
biasing the split collet toward the inclined surface of the pocket.

Documents:

http://ipindiaonline.gov.in/patentsearch/GrantedSearch/viewdoc.aspx?id=Gfap81NE6w/QSHCjrXbc/Q==&loc=wDBSZCsAt7zoiVrqcFJsRw==

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Patent Number

271512

Indian Patent Application Number

1994/KOLNP/2007

PG Journal Number

09/2016

Publication Date

26-Feb-2016

Grant Date

24-Feb-2016

Date of Filing

04-Jun-2007

Name of Patentee

BECTON, DICKINSON AND COMPANY

Applicant Address

1 BECTON DRIVE FRANKLIN LAKES NEW JERSEY

Inventors:

#	Inventor's Name	Inventor's Address
1	MOULTON, WILLIAM G.	3026 WEST 7050 SOUTH WEST JORDAN UT 84084
2	BRIMHALL, GREG L.	3838 VALLEY WEST DRIVE WEST JORDAN UT 84084

PCT International Classification Number

A61M 5/32

PCT International Application Number

PCT/US2005/044142

PCT International Filing date

2005-12-06

PCT Conventions:

#	PCT Application Number	Date of Convention	Priority Country
1	60/633,413	2004-12-07	U.S.A.