Patent Application
20110066107
This invention relates generally to the field of hypodermic needles, and more specifically, a protective device to reduce inadvertent needlestick incidents.
Infectious diseases can be transmitted to medical personnel and others by way of inadvertent needle sticks. Needlestick injuries occur frequently, most often between the time the medication is injected into the patient and the time the syringe is disposed of. Injuries occur before, during and after the clinical process. Needlestick injuries after use of the needle have been reduced with current needle protective devices, but needlestick injuries remain unaddressed during the clinical process. It is therefore desirable to provide a needle protective device to reduce the number of needlestick incidents during the complete clinical process.
According to various embodiments, a needle protective device is provided for reducing inadvertent needle sticks. In one embodiment, the needle protective device comprises a tubular member and an end cap. The device can be activated automatically in a hygienic manner prior to the clinical procedure using conventional clinical techniques such as the forward motion of a needle towards a patient or filling vial while the hands of a user remain safely behind the tip of the needle. In one aspect, upon removal of the needle tip from a patient or filling vial, the hands of the user can remain behind the exposed tip of the needle with automatic, passive encasement of the needle tip. Thus, the automatic passive activation and automatic passive encasement of the tip of the needle can help insure the user that the safety feature is activated and remains in a protective condition throughout the entire clinical process.
In one aspect, the tubular member can be formed of resilient flexible material and can be mounted on a needle hub. The tubular member can extend about at least a portion of a needle projecting from the needle hub. In this aspect, the tubular member can be selectively axially movable between a first relaxed position and a second compressed position. When the tubular member is moved from the first relaxed position to the second compressed position, the tubular member can store resilient force.
In another aspect, the end cap can be mounted to an end of the tubular member opposite the needle hub. The tubular member can have a plurality of axial slits formed thereon that extend axially over at least a portion of the tubular member. Optionally, the axial slits can be diametrically opposed to each other and can have notches selectively formed along a portion of the edges of the axial slits, which allow portions of the tubular member to controllably bow outwardly when the tubular member is axially compressed such that the end cap is moved axially towards the needle hub. Additionally, the size of the axial slits can increase or decrease the amount of resilient force stored within a compressed tubular member.
In one aspect, the end cap can be formed from a rigid material and can define a first chamber that has an opening through which a user of the device can selectively pass the needle tip. In another aspect, the end cap can have one or multiple molded or inserted locking members that interact in a flexible, locking and/or keyed condition to allow at least a portion of a needle one-way directional access into a second chamber in order to lock the needle into the second chamber of the end cap, thus preventing the reuse of the device. In this aspect, the locking member(s) can provide tactile feedback to a user when the needle is in the process of being locked. Additionally, in this aspect, the locking member(s) can interact to support the needle in the open position while guiding the needle during automatic passive activation.
In a further aspect, a pierceable protective covering can be attached to, inserted into, or incorporated into the end cap such that the protective covering seals the opening of the end cap. In one aspect, the pierceable protective covering can comprise infection control or aseptic materials. The pierceable protective covering can be selectively pierced by the needle tip as the end cap is moved axially toward the first end of the tubular member when the tubular member is moved from the first relaxed position to the second compressed position. The pierceable protective covering can be formed from a material having a thickness configured to apply a compressive force onto the needle when pierced that is less than the resilient force stored therein the tubular member when the tubular member is moved from the first relaxed position to the second compressed position. Thus, when it is not necessary for a tip of the needle to be exposed, the resilient forces in the compressed tubular member can cause the tubular member to move axially so that the tip of the needle will reside within the first chamber in the end cap. Additionally, the pierceable protective covering can provide a tactile feedback to a user when pierced.
In one aspect, the opening in the end cap can be aligned with the tip of the needle. In another aspect, the tubular member can have a skewed end mounted on the needle hub, so that the longitudinal axis of the tubular member is not parallel with the longitudinal axis of the needle. In this aspect, the opening in the end cap can be misaligned with the tip of the needle, thereby requiring a user to move the end cap in order to pass the needle through the opening for use, or into the first chamber in the end cap for user protection.
In use, the needle protective device can help reduce the number of inadvertent needlestick injuries. In one embodiment, with the pre-alignment of the needle tip to the opening in the end cap, the device can automatically be passively activated prior to the clinical procedure by a forward or downward pressure on or by any direct contact of the end cap to a second surface, such as, for example and without limitation, the skin of a patient, under pressure. The needle protective device allows users of the device to maintain their hands behind the exposed needle tip throughout the activation and clinical procedures, with automatic, passive activation and/or encasement of the needle tip during drug filling steps, intermediary clinical steps, procedural interruptions, and the like. This passive activation can provide ease of use through direct needle contact to a patient, filling bottle or other biological surfaces.
Additional advantages of the invention will be set forth in part in the description that follows, and in part will be obvious from the description, or can be learned by practice of the invention. The advantages of the invention will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed.
In the accompanying drawings which illustrate by way of example preferred embodiments of the invention:
The present invention can be understood more readily by reference to the following detailed description, examples, drawings, and claims, and their previous and following description. However, before the present devices, systems, and/or methods are disclosed and described, it is to be understood that this invention is not limited to the specific devices, systems, and/or methods disclosed unless otherwise specified, as such can, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular aspects only and is not intended to be limiting.
As used in the specification and the appended claims, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to a “needle” can include two or more such needles unless the context indicates otherwise.
Ranges can be expressed herein as from “about” one particular value, and/or to “about” another particular value. When such a range is expressed, another aspect includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another aspect. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint.
As used herein, the terms “optional” or “optionally” mean that the subsequently described event or circumstance can or can not occur, and that the description includes instances where said event or circumstance occurs and instances where it does not.
As used herein, the term “needle hub” means any needle hub, retractable syringe luer slip or lock collar, or any other syringe/cylinder type hubs needle configuration, wherein a needle is projecting from a hub, retractable syringe, luer slip or lock collar or other cylinder type needle hub device.
As used herein, the term “passive activation” means any safety feature wherein a needle protective device is activated through a normal course of a clinical process use, such as, for example and without limitation, forward or downward motions of the tip or needle towards a patient during the clinical injections procedures where the hands and fingers remain behind the needle tip.
As used herein, the term “passive encasement” means any safety feature wherein a needle protective device is pre-activated before clinical use thereby providing automatic encasement of the needle tip during and after the clinical risk window, such as, for example and without limitation, during medication draw-up prior to injections, procedural interruptions due to patient instability, and throughout the continuum clinical procedure to disposal.
Reference will now be made in detail to the present preferred embodiment(s) of the invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers are used throughout the drawings to refer to the same or like parts.
Referring to
The tubular member 14 can have a longitudinal axis, a first end 13 and a second end 15. The first end can be configured for mounting on a needle hub 22, as will be described below. The second end of the tubular member can be configured for mounting the end cap thereon, as will also be described below. In one aspect, the tubular member can be selectively axially movable between a first relaxed position and a second compressed position, by urging the second end 15 of the tubular member substantially along the longitudinal axis of the tubular member 14 towards the first end 13. In this aspect, the tubular member can store resilient force when the tubular member 14 is moved from the first relaxed position to the second compressed position.
In another aspect, the tubular member 14 can have a gripping means 45 formed thereon. In one aspect, the gripping means can consist of a flange on the tubular member at or adjacent each end. In another aspect, the gripping means can include a plurality of formations disposed about the circumference of the tubular member 14. These formations can be in various forms, such as, for example and not meant to be limiting, lugs or ribs. As illustrated in
In yet another aspect, the first end 13 of the tubular member can be skewed, such that a plane in which the first end is located is not normal to the longitudinal axis of the tubular member 14. When the skewed first end of the tubular member is mounted to the needle hub 22, as will be described more fully below, the skew of the first end of the tubular member causes the longitudinal axis of the tubular member 14 to be unparallel to the longitudinal axis of the needle. In this aspect, the second end 15 of the tubular member can be straight, such that a plane in which the second end is located is normal to the longitudinal axis of the tubular member 14.
In still another aspect, the tubular member 14 can have a plurality of axial slits 18 formed thereon. The axial slits can extend axially over at least a portion of the tubular member, and the axial slits can be diametrically opposed to each other. The axial slits 18 can terminate at either end or both ends in substantially circular end notches 20, configured to reduce tearing of the axial slits which can occur as the ends of the axial slits are placed under tension when the tubular member is axially compressed. In another aspect, notches 50 can be selectively formed along the edges of the axial slits 18 in the tubular member 14. The notches 50 help ensure that when the tubular member 14 is axially compressed such that the second end 15 of the tubular member 14 is moved axially towards the first end 13 of the tubular member, portions of the tubular member will be disposed to fold or bow outwardly enabling the end cap 16 to be retracted until it encounters the needle hub 22, as will be described more fully below. In one aspect, the notches 50 can be formed at any location along the slits. In another aspect, the size of the axial slits and/or the end notches 20 and/or the notches 50 can increase or decrease the amount of resilient force stored within a compressed tubular member. For example, an increase in the width and/or length of the axial slits 18 means there can be a corresponding removal of material forming the tubular member 14, and therefore the amount of resilient force capable of being stored in a compressed tubular member can decrease. In another aspect, mating notches can be formed at any location along the slits. The mating notches, according to one aspect, can be configured to mate or attach to bosses to form a mechanical connection between the tubular member and the mating part to increase the pull force between the tubular member and the mated part.
As illustrated in
In one aspect, an opening 34 can be defined therein the blocking surface of the end cap that is in communication with the first chamber 28. In this aspect, a passage 32 can extend from the opening 34 in the blocking surface 30 to the first chamber. In one aspect, the opening in the blocking surface can be circular, however, the opening 34 can be other shapes, such as, for example and without limitation, D-shaped, oval, square, and the like. A wall 42 of the passage 32 can extend from the blocking surface in a direction along the longitudinal axis of the end cap, so that the wall of the passage and the blocking surface 30 define a safety chamber 44 for the tip 27 of the needle 26. In one aspect, the passage can be flared, so that a cross-sectional diameter of the passage 32 decreases as the passage progresses from the opening 34 in the blocking surface 30 towards the first end 29 of the end cap 16. The flared passage can reduce the likelihood that the tip 27 of the needle 26 can be snagged on the wall 42 of the passage and, in turn, can reduce the likelihood that the tip of the needle can thereby become damaged. In another aspect, as illustrated in
In one aspect, a flange 36 can extend around at least a portion of an outer wall 21 of the end cap. In another aspect, illustrated in
In another embodiment, the end cap 16 can be substantially frustoconical in shape and define a first chamber 28. In this embodiment, the first end 29 and the second end 31 of the end cap can be open. The second end of the end cap can define opening 34. The inner wall 23 of the first chamber 28 can be formed with one or more guide ribs 38. In one aspect, the guide ribs 38 can be substantially parallel to each other. In another aspect, the guide ribs can diverge rearwardly away from each other as they become closer to the first end 29 of the end cap in order to facilitate guidance of the tip of the needle. In yet another aspect, a passage 32 can extend from the opening 34 to the first chamber 28. In this embodiment with the open second end 31 of the end cap 16, when assembled as a component of the needle protection device, no alignment of the needle 26 with the opening 34 of the end cap can be necessary in order to expose the needle, as will be described more fully below. Instead, the needle may be exposed by passive activation, as will also be described more fully below.
In one aspect, the end cap 16 can be provided with a visual indicator 19, such as, for example and not meant to be limiting, a colored dot or a raised area, to provide a reference point for users of the needle protective device 10. The visual indicator can allow a user to quickly ascertain the orientation of the needle relative to the guide ribs 38 and/or opening 34 so that an injection can be administered properly.
In another embodiment, and as illustrated in
In another aspect, the locking means can provide a user of the device tactile feedback, so that the user can be aware that the needle is locked or in the process of locking without visually seeing this condition. In yet another aspect, the locking means can be configured to support the needle 26 when the needle is in an unlocked position within the end cap 16. In another aspect, the locking means can be configured to guide the needle during passive activation. In yet another aspect, the locking means can be configured to prevent movement of the needle from the first chamber to the second chamber during passive activation. In still another aspect, the locking means of the end cap can prevent the reuse of a needle after the needle 26 has been locked within the second chamber 100 of the end cap.
FIGS. 5 and 7-11 illustrate embodiments of an end cap locking means. In one embodiment, illustrated in
In another aspect, illustrated in
Another embodiment of an end cap locking means is illustrated in
In this embodiment, the first locking member 102 and the second locking member 104 can interact such that, when the needle protective device 10 is assembled as described below, a needle can be urged against the second locking member 104, thereby causing the second locking member to flex away from the first locking member 102 momentarily, allowing the needle to enter the second chamber 100. Alternatively, a needle can be urged against the first locking member, thereby causing the first locking member to flex away from the second locking member momentarily, allowing the needle to enter the second chamber 100. In another aspect, and as illustrated in
Yet another embodiment of an end cap locking means is illustrated in
In one aspect, the combination of the materials for the protective covering 17 and the thickness of that material can be selected so that, when the protective covering is in use, the compressive force exerted onto the needle 26 by the protective covering is less than the resilient force stored therein the compressed tubular member 14 when it is in the second, compressed position. Thus, the protective covering 17 can exert a compressive, frictional force on the needle that is small enough to allow the needle protective device 10 to move freely axially under forces supplied to the needle protective device by the compressed tubular member. In another aspect, the protective covering 17 can provide a barrier that provides a user of the needle protective device a tactile feeling as the tip of the needle penetrates the protective covering. In this aspect, the user can know the approximate location of the tip 27 of the needle without visually seeing it so that the user can know that there is an exposed needle tip.
In another embodiment, the needle protective device 10 can comprise a flexible tubular member 14, an end cap 16, and a cover. In one aspect, the cover can be formed from a relatively hard thermoplastic material, such as, for example and not meant to be limiting, polystyrene. The cover can be a hollow tube having a closed end and an open end. The inner diameter of the cover can be dimensioned so that the tubular member 14 and the end cap 16 can fit therein the cover. In another aspect, the cover can have a length dimensioned to extend from the closing wall of the end cap 16 to the needle hub 22, when the device is assemble, as will be described below. In yet another aspect, the cover can be dimensioned so that the needle is selectively completely enclosed therein, thus maintaining the needle in a sterile condition.
In order to assemble the needle protective device, the second end 15 of a tubular member 14 can be frictionally engaged with the first end 29 of an end cap 16 by stretching the second end of the tubular member over the first end of the end cap. In one aspect, the end cap can have a pierceable protective covering 17 over the opening 34 of the end cap. In other aspects, the protective covering can be inserted into the opening or the slot 37 of the end cap. The protective covering can be attached to the end cap by conventional means, such as, for example and not meant to be limiting, adhesives or a friction fitting.
The assembled needle protective device 10 can then be inserted onto a needle assembly by stretching the first end 13 of the tubular member 14 over the needle hub 22 until the first end of the tubular member is adjacent the end rim 24. As illustrated in
In one aspect, if the first end 13 of the tubular member is skewed, after assembly on the needle protective device onto the needle hub, the longitudinal axis of the tubular member 14 can be unparallel to the longitudinal axis of the needle 26. With reference to
In another aspect, the tubular member 14 can be mounted on the needle hub 22 in such a way that a bevel on the tip of the needle 26 slopes in the opposite direction as the blocking surface 30 of the end cap. Thus, by simply viewing the blocking surface and/or the visual indicator 19, the user can know that the bevel of the needle is in the correct disposition relative to a patient's skin. In this aspect, it is not necessary for the user to visually inspect the tip 27 of the needle itself to ensure this result.
In use, the needle assembly and thus, the needle protective device 10 can be mounted onto a syringe. In order to administer an injection, if a cover is present, the user can remove it to expose the end cap 16. If the tip 27 of the needle 26 is pre-aligned with the opening 34 in the second end 31 of the end cap, no alignment by the user is necessary and passive activation of the needle protective device 10 by the user can occur. If the needle is not pre-aligned with the opening 34 in the second end of the end cap, the needle 26 can be substantially co-axially aligned with the passage 32 and the opening 34 in the second end 31 of the end cap. If the end cap has a blocking surface 30 or a end dam 90 the end cap can be moved so that the end cap 16 is displaced sideways until the needle 26 is brought into contact with one of the guide ribs 38 which can automatically guide the tip of the needle into alignment with passage 32. If the end cap does not have guide ribs, the end cap 16 can be moved until the tip 27 of the needle 26 is aligned with passage 32. In another aspect, if the needle is not pre-aligned with the opening 34 in the second end of the end cap and if the end cap has a visual indicator 19, the end cap can be moved until the tip of the needle is aligned with passage by referring to the visual indicator. If the end cap does not have a blocking surface 30 or an end dam 90, the tip of the needle can be aligned with the passage without being moved by the user.
After alignment of the needle with the passage 32 and/or the opening 34 of the end cap, the tubular member 14 can then be axially compressed by the user to urge the second end 15 of the tubular member towards the first end 13 of the tubular member, with the center portion of the tubular member bowing outwardly. As one will appreciate, as the tubular member 14 is axially compressed, the tip 27 of the needle slides through the passage and the opening of the end cap 16. If a protective covering 17 is present, the needle will pierce the protective covering, which can provide the user a tactile feeling so that the location of the tip of the needle 26 is known. With the needle tip thus exposed, the tip 27 of the needle can be inserted into a patient, filling bottle, or a biological surface, and the tubular member 14 can be released. Resilient forces present in the axially compressed tubular member cause the second end 15 of the tubular member to slide forward and move away from the first end 13 of the tubular member axially, until the blocking surface 30 lies against the patient, filling bottle, or biological surface.
At the end of the injection procedure, as the needle 26 is withdrawn from the patient, filling bottle, or other biological surface, resilient forces present in the axially compressed tubular member 14 cause the tubular member to expand axially such that the second end 15 of the tubular member slides forward until the passage 32 in the end cap is extended over the needle 26 and the tip 27 of the needle is located in the first chamber 28, thereby reducing the likelihood that a user can receive an inadvertent needlestick. In one embodiment, if the end cap 16 has a locking means, as illustrated in
In another embodiment, as illustrated in
In another embodiment, as illustrated in
Although several embodiments of the invention have been disclosed in the foregoing specification, it is understood by those skilled in the art that many modifications and other embodiments of the invention will come to mind to which the invention pertains, having the benefit of the teaching presented in the foregoing description and associated drawings. It is therefore understood that the invention is not limited to the specific embodiments disclosed herein, and that many modifications and other embodiments of the invention are intended to be included within the scope of the invention. Moreover, although specific terms are employed herein, they are used only in a generic and descriptive sense, and not for the purposes of limiting the described invention.
This application claims priority to and the benefit of U.S. Provisional Application No. 61/127,742, filed on May 14, 2008, which is incorporated in its entirety in this document by reference.
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/US09/44001 | 5/14/2009 | WO | 00 | 11/12/2010 |
| Number | Date | Country | |
|---|---|---|---|
| 61127742 | May 2008 | US |
