Automatic-locking safety needle covers and methods of use and manufacture.

(54) Title: AUTOMATIC LOCKING SAFETY NEEDLE COVERS AND METHODS OF USE AND MANUFACTURE OF THE SAME.

(54) Title: AUTOMATIC-LOCKING SAFETY NEEDLE COVERS AND METHODS OF USE AND MANUFACTURE.

(57) Summary

A single-use needle cover is disclosed to darken, protect, or hide from view at least a portion of a needle before, during, and / or after an injection and / or aspiration procedure. In some embodiments, the cover includes a housing that at least partially contains the needle and configured to engage a syringe, wherein the housing includes a shaft and a guide element. In some embodiments, a sleeve has a plurality of tracks configured to slidably receive the guide member, wherein the sleeve is configured to retract, extend, and rotate relative to the housing. In some embodiments, after the sleeve has been retracted and extended once, a first fastening element inhibits further retraction of the sleeve and a second fastening element inhibits rotation of the sleeve.

(57) Abstract

A single-use needle cover configured to obscure, protect, or hide at least a portion of a needle from view before, during, and / or after an injection and / or aspiration procedure is disclosed. In some performances, the cover ineludes a housing at least partially containing the needle and configured to couple to a syringe, where the housing ineludes an axis and a guide member. In some performances, a sleeve has a plurality of tracks configured to slidingly receive the guide member, where the sleeve is configured to retract, extend, and rotate with respect to the housing. In some performances, after the sleeve has been retracted and extended one time, a first locking member inhibits further retraction of the sleeve and a second locking member inhibits rotation of the sleeve.

AUTOMATIC LOCKING SAFETY NEEDLE COVERS AND

METHODS OF USE AND MANUFACTURE OF THE SAME

FIELD OF THE INVENTION

Certain embodiments disclosed herein are concerned with needle covers and needle cover assemblies for medical devices such as syringes and are in particular related to obscuring portion of the needle from view and aiding in fluid transfer.

BACKGROUND OF THE INVENTION

Syringes are used throughout the medical industry for the injection and extraction of a variety of fluids and solutions to and from the human body. Due to the numerous potential hazards associated with the handling and handling of bodily fluids and particularly blood, there are a number of known safety features that are frequently incorporated into various types of syringes and syringe needles. For example, many syringe needles are provided with a removable cap that generally prevents the needle from sticking while the cover is in place. When the cap is removed, the needle is exposed. These covers are removed prior to an injection and / or aspiration procedure and replaced after the injection and / or aspiration procedure before the needle is discarded. Among other concerns, this removal and replacement procedure creates a risk of accidental needle sticks.

Syringes and syringe needles are frequently configured such that at least the needles are disposable, that is, they are intended to be used one. only once and then discarded. This procedure reduces the likelihood of transferring blood or tissue-borne diseases from one patient to another. For this purpose, many syringe needles are configured to be quickly and easily detached from an appropriately configured syringe body. In this way, the syringe body can be reusable. and made of a relatively durable material such as metal, while disposable needle assemblies can be made of relatively inexpensive plastic or the like.

BRIEF DESCRIPTION OF THE INVENTION

Various variations and combinations of needle covers are revealed. In certain embodiments, a single-use needle cover comprises a housing configured to engage a syringe and at least partially (or fully) contains or shields the needle from view, while the housing includes a guide element, a first fixing element, and, a second fixing element; a sleeve configured to move or plug-in between an extended position and a retracted position with respect to the housing, where the extended position generally covers a tip distant from the needle and the retracted position exposes at least a portion of the distant tip of the needle and where the cuff is predisposed to the extended position. In some embodiments, movement or plugging of the sleeve from the extended position to the retracted position rotates the sleeve with respect to the housing, transfers the guide element from a first clamp included in the sleeve, and engages with a first element. Fixing; where the movement or plugging of the sleeve from the retracted position to the extended position engages the second fixing element and where the first and second fixing elements inhibit the movement or plugging of the cover to prevent reuse. In some arrangements, the first fastening element comprises a rib on the housing. In some embodiments, the second attachment member comprises an arm that extends radially inward over the housing. In some embodiments, the sleeve further includes a flange that engages with the first and second fasteners. In some arrangements, the first fastening element comprises a rib on the housing, the second fastening element comprises an arm extending radially inward on the housing and the sleeve further includes a flange that engages the first and second fastening elements. fixation. In some embodiments, the sleeve includes a third track that intersects the first and second tracks. The third track can intersect the first track next to the intersection of the third track and the second track.

In accordance with certain arrangements, a single-use needle cover may comprise: a housing that at least partially contains the needle and configured to engage with a syringe, wherein the housing includes a shaft and a guide element; a sleeve configured to receive a point distant from the needle and to translate from a first position and a second position, where the sleeve rotates with respect to the housing for at least some of the translation, where the sleeve includes a plurality of configured tracks to receive the guide element and where the translation of the sleeve engages a first fixing element configured to inhibit the reuse of the needle cover. In some embodiments, the first position covers the distant tip of the needle and the second position exposes the distant tip of the needle. In the cover, the first fastening element can inhibit reuse of the needle cover by inhibiting translation of the sleeve. The translation of the sleeve can also couple to a second fixing element configured to inhibit the reuse of the needle cover. The second fastening element can inhibit reuse of the needle cover by inhibiting rotation of the sleeve. In some embodiments, the first attachment element is an arm attached to the housing and the second attachment element is a rib attached to the housing. A spring can propel the sleeve into the first position. In some embodiments, the sleeve can be moved from the first position to the second position substantially without hindrance. The sleeve may further include a flange configured to mate with the first fastener. The flange may further be configured to mate with a second fastening element. The first fastening element can be attached as the sleeve moves from the first position to the second position. A second fastening element can be coupled as the sleeve moves from the second position to the first position.

In accordance with certain embodiments, a single-use needle cover manufacturing method may comprise: form of a housing, wherein the housing at least partially contains the needle and is configured to engage a syringe, wherein the housing includes a shaft and a guide member ;, forming a sleeve, wherein the sleeve is configured to receiving a point distant from the needle and to translate from a first position and a second position, where the sleeve rotates with respect to the housing during at least some of the translation, wherein the sleeve includes a plurality of tracks configured to receive the guide element and wherein the translation of the sleeve engages with a first fastening element configured to inhibit reuse of the needle cover. In some methods, the first position can cover the distant tip of the needle and the second position can expose the distant tip of the needle. The first fastening element can inhibit reuse of the needle cover by inhibiting translation of the sleeve. The translation of the sleeve may also engage a second fastener configured to inhibit reuse of the needle cover. The second fastening element can inhibit reuse of the needle cover to inhibit the rotation of the sleeve.

In certain embodiments, a method of protection against unintentional needle bites with a needle cover may comprise: forming a housing, wherein the housing at least partially contains the needle and is configured to engage with a syringe, wherein the housing includes a shaft and a guide member, forming a sleeve, wherein the sleeve includes a plurality of tracks configured to receive guide element, wherein the sleeve is configured to receive a distant tip of the needle and to move between a first position and a second position, where the first position covers the distal tip of the needle and the second position exposes the distal tip of the needle and where the sleeve rotates with respect to the housing during at least some of the movement and where the movement of the sleeve engages a first fastening element configured to inhibit further movement of the sleeve. In some embodiments, the first fastening element inhibits reuse of the needle cover by inhibiting rotation of the sleeve. In some embodiments, the first fastening element inhibits reuse of the needle cover by axial movement of the sleeve. Movement of the additional sleeve may further engage a second fastening element configured to inhibit reuse of the needle cover by inhibiting axial movement of the sleeve. In some embodiments, the second fastening element inhibits reuse of the needle cover by inhibiting axial sleeve rotation from inhibiting the sleeve.

BRIEF DESCRIPTION OF THE FIGURES

Figure 1 illustrates a perspective view of one embodiment of a needle cover.

Figure 1A illustrates a cross-sectional view of the embodiment of Figure 1 along line 1A-1A in a first ready-to-use position, fully extended and unlocked.

Figure IB illustrates a cross sectional view along line IB-IB.

Figure 1C illustrates a perspective view of the embodiment of Figure 1 with a removable lid in the closed position.

Figure ID illustrates a perspective view of the embodiment of Figure 1 with a removable lid in the open position.

Figure 2 illustrates a perspective view of the embodiment of Figure 1 in a second partially retracted position.

Figure 2A illustrates a cross sectional view along line 2A-2A.

Figure 2B illustrates a cross sectional view along line 2B-2B.

Figure 3 illustrates a perspective view of the embodiment of Figure 1 in a third partially retracted position, in which a flange has engaged with a rotational fastener.

Figure 3A illustrates a cross sectional view along line 3A-3A.

Figure 3B illustrates a cross sectional view along line 3B-3B.

Figure 4 illustrates a perspective view of the embodiment of Figure 1 in a fourth partially retracted position, in which the rotational fixation element has been locked.

Figure 4A illustrates a cross sectional view along line 4A-4A.

Figure 4B illustrates a cross sectional view along line 4B-4B.

Figure 5 illustrates a perspective view of the embodiment of Figure 1 in a fifth position retracting.

Figure 5A illustrates a cross sectional view along line 5A-5A.

Figure 6 illustrates a perspective view of the embodiment of Figure 1 in a sixth partially extended position, in which the flange has been axially coupled with a fastener.

Figure 6A illustrates a cross sectional view along line 6A-6A.

Figure 7 illustrates a perspective view of the embodiment of Figure 1 in a seventh partially extended position, in which the flange has been additionally coupled with at least one axial fastening element.

Figure 7A illustrates a cross sectional view along line 7A-7A.

Figure 8 illustrates a perspective view of the embodiment of Figure 1 in an eighth fully extended reuse-prevented position.

Figure 8A illustrates a cross sectional view along line 8A-8A.

Figure 9 illustrates a perspective view of another embodiment of a needle cover.

Figure 9A illustrates a cross-sectional view along line 9A-9A in a ready-to-use position, fully extended and unlocked.

Figure 9B illustrates a cross sectional view along line 9B-9B.

Figure 10 illustrates a perspective view of the embodiment of Figure 9 in a partially retracted position.

Figure 10A illustrates a cross sectional view along line 10A-10A.

Figure 10B illustrates a cross sectional view along line 10B-10B.

Figure 11 illustrates a perspective view of the embodiment of Figure 9 in a second fully retracted position.

Figure 11A illustrates a cross sectional view along line 11A-11A.

Figure 11B illustrates a cross sectional view along line 11B-11B.

Figure 12 illustrates a perspective view of the embodiment-of Figure 9 in a first partially extended position.

Figure 12A illustrates a cross sectional view along line 12A-12A.

Figure 12B illustrates a cross sectional view along line 12B-12B.

Figure 13 illustrates a perspective view of the embodiment of Figure 9 in a second partially extended position.

Figure 13A illustrates a cross sectional view along line 13A-13A.

Figure 13B illustrates a cross sectional view along line 13B-13B.

Figure 14 illustrates a perspective view of the embodiment of Figure 9 in a fully extended, reuse-prevented position.

Figure 14A illustrates a cross sectional view along line 14A-14A.

DETAILED DESCRIPTION OF PREFERRED MODALITIES

A variety of examples of needle covers are described below to illustrate various examples that can be used to obtain the desired improvements. These examples are illustrative only and are not intended in any way to restrict the general invention presented in the various aspects and elements of this invention. For example, although the modalities and examples are provided herein in the medical field, the invention is not confined exclusively to the medical field and certain modalities may be used in other fields. Furthermore, the phraseology and terminology used herein is for the purpose of description and should not be construed as limiting. No element, structure or stage disclosed herein is essential or indispensable.

Figure 1 illustrates a needle cover 10 that can be removably attached to a standard or specially configured syringe (not shown). Cover 10 includes elements and components discussed in detail below, which generally obscure, protect or conceal at least a portion (or substantially all) of a needle 16 from view before, during and / or after an injection procedure and / or aspiration, thereby reducing alleviating at least some of anxiety or fear that you might otherwise otherwise feel for certain patients or other individuals after viewing the needle 16. In some embodiments, all or almost all of the needle is obscured, hidden or protected by cover 10. Cover 10 may also include elements and components that allow a fluid transfer procedure to be performed prior to an injection and / or aspiration procedure without automatically preventing additional use, but which automatically prevents cover 10 and the associated needle. 16 are used more than once to perform an injection and / or aspiration procedure. As used herein, the terms automatically and automatically and similar terms are intended to have their ordinary meanings in the field. In some modalities, as the context reflects, these terms refer to a mechanism or process that occurs in the normal use of a product or that occurs while the user is carrying out another process, without requiring an additional stage or manipulation by the user. user to get the desired result. Although, the illustrated cover 10 is configured to be attached to and removed from a syringe, the cover 10 may instead be integrally formed with the syringe or attached, either removably or permanently or to another medical implement. Whether in one case or the other, the syringe is generally of a known type suitable for the extraction and injection and / or aspiration of fluids or other solutions by means of the cover 10. The fixation system and / or reuse inhibition elements of cover 10 could be used with many different types of medical and non-medical products.

In the illustrated construction of Figures 1 and 1A, cover 10 includes a generally cylindrical housing 14 that includes an axis 18 along which needle 16 is placed. A distal end of housing 14 engages a sleeve 12 configured to move lengthwise and at least partially rotate about axis 18. As used herein, proximal, or any derivative thereof, refers to a direction toward the end of the cover 10 that attaches to a medical device, eg, a syringe; Distant, or any derivative thereof, refers to a direction toward the end of the cover 10 that is brought into contact with the surface to be penetrated with the needle 16, eg, the patient's skin. A channel 26 and an opening 28 are included in the sleeve 12 in order to allow the needle 16 to pass through it.

In some embodiments, a proximal end 34 of housing 14 may comprise a hub 20 that is configured for either removable or permanent attachment to the syringe or that can be integrally formed with the syringe. For example, hub 20 may include internal or external threading or other appropriate coupling, fastening or locking elements such as lugs, grooves, projections, snap / insert fittings, and the like, which may be provided in various combinations on hub 20 for coupling to the syringe. The coupling elements can be coupled with corresponding elements provided on the syringe to removably couple the cover 10 to the syringe. In some embodiments, the 2 0 hub can be permanently attached (eg, by sonic welding, adhesives, push-fit / insert or the like) or integrally formed with the syringe. In some embodiments, housing 14 includes a generally cylindrical reduced needle support portion 30 that extends axially from hub 20 and supports needle 16. As shown, housing 14 and / or hub 2 0 are in fluid communication with needle 16, thus allowing fluid to pass between syringe and needle 16.

The inner surface 22 of housing 14 may include a central chamber 36. The distal end 38 of housing 4 may include a radially outwardly extending result including an opening 42 communicating with chamber 36. Opening 42 slidably receives sleeve 12 which in turn receives and at least partially covers needle 16 as will be discussed in detail hereinafter. A guide member 44 extends radially inward from shoulder 40 and is configured to mate with one or more tracks formed in sleeve 12. Outer surface 24 of housing 14 may include an outer portion 46 that is textured, mulattoed or similar to facilitate the holding of the cover 10.

As shown in Figures 1 and 1A, housing 14 may include at least one axial locking element 50. In some embodiments, axial locking element 50 is positioned at least partially within an opening 48 included in the housing 14. As shown, the first end 52 of the axial clamping element 50 can be coupled to the housing 14, while the second end 54 of the axial clamping element 50 can be arranged radially inward compared to the inner surface 22. In some embodiments, the axial clamping element 50 is generally resilient such that the radially disposed second ends 54 can then flex back to the original position even after the ends 54 have been deflected radially outward. In some embodiments, the first end 52 is larger than the second end 54, for example axial fastening element 50 can be tapered from first end 50 to second end 54. In some embodiments, the axial fastening element 50 includes a retaining element, such as a hook, fastener, catch, ratchet, or other structure.

In the illustrated arrangement housing 14 is of unitary construction. This can be advantageous in that it reduces the. total number of components to be assembled to form the cover. In some embodiments, housing 14 is formed of a plurality of components, for example, a proximal portion and a distal portion of housing 14 may be separate components that are joined using techniques such as but not limited to sonic welding, adhesives, snap fit insertion or the like.

Referring to Figure 1A, illustrated sleeve 12 includes a proximal end 70 positioned within chamber 36 and a distal end 62 generally covering distal tip 96 of needle 16. Proximal end 60 includes a flange that extends radially outward 64 which sits against shoulder 40 at distal end 38. As shown, proximal end 60 may also include an axially extending and substantially annular locating portion 66 that positions a spring-shaped drive member 70. In some embodiments, the inner surface 22 of proximal end 34 of housing 14 includes a similar portion 68 for locating spring 70. Sleeve 12 may include a collapsible portion.

In the illustrated embodiment, spring 7 0 engages and extends between proximal 60 of sleeve 12 and proximal end 34 of housing 14. Spring 70 drives sleeve 12 into an extended position in which flange 64 of sleeve 12 it is driven in engagement with shoulder 40 at the distal end of housing 38 and sleeve 12 completely covers distal tip 96 of needle 16. Many types of springs can be employed, such as, but not limited to, a coil spring, conical spring, wave spring, Belleville washer, or the like. In some embodiments, spring 70 is a coil spring that has a free length of about 25mm and a spring ratio of about 0.12 N / mm through the linear position of the spring deflection. Other constructions can include softer or stiffer springs depending on the application and can be constructed of substantially any appropriate material. In some embodiments, spring 70 is configured to facilitate retraction of sleeve 12 by a user applying distant pressure to syringe and / or cover 10 with only one hand. Progressive springs and / or multiple springs of variable lengths can also be used to provide a variable effective spring ratio during sleeve movement 12 between fully extended and fully retracted positions.

Channel 26 may extend through sleeve 12 and include a proximal portion 90, a tapered portion 92, and a distal portion 94. Proximal portion 90 may be configured to receive the needle holder portion 30 of housing 14 as custom that sleeve 12 is retracted. For example, in some embodiments, the needle bearing portion 3 0 has a diameter of at least about 0.5 mm and / or less than or equal to about 5 mm and an axial length of at least 2 mm and / or less than or equal to about 2.5 mm and proximal portion 90 of channel 26 has a diameter of at least 0.6 mm and / or less than or equal to about 6 mm and an axial length of at least about 2.5 mm and / or less than or equal to, about .25 mm. In some embodiments, the diameter of proximal portion 90 is greater than the diameter of distant portion 92. In the arrangement shown, tapered portion 92 transitions between proximal and distant channel portions 90, 94. Tapered portion 92 may guiding the distant needle 94. In the embodiment shown, the distal portion 94 of the channel 26 has a diameter that is about the same as the outer diameter of the needle 16 in order to for example support the needle 16.d

Turning now to Figure IB, the illustrated flange 64 includes an outwardly extending portion 100 from which an impeding element 102, such as a resilient element extends, for example circumferentially, radially, axially, or a combination thereof. or the like. The end 104 of the impeding element 102 shown is formed as a radially outwardly extending wedge (such that the radial width of the impeding element 102 is increased towards the end 104) having an inclined face 106 and a face in flat general 108. Similarly, a generally wedge-shaped rotational fastening element 110, for example an axial rib, extends radially inward from the inner surface 22 of housing 14 and includes an inclined face 112 and a generally flat face 14. In the variant shown, the inclined face 112 is configured to be in the opposite direction as the inclined face 106. Although the end 104 and rotational fixation element 110 shown are generally wedge-shaped, many shapes can be used, such as but not limited to hemispherical, frusto-conical, undulating or the like. In some embodiments, the axial length of the rotational fastening element 110 is greater than the axial length than the impeding element 102 or sleeve 64. In some embodiments, at least a portion of the impeding element 102 is configured to fit at least a portion of the rotational fastening element 110 or vice versa. For example, the impeding element 102 may comprise a tab configured to fit within an inclined slot in the rotational fastening element 110. In some embodiments, at least a portion of the impeding element 102 is configured to fit an opening in the housing 14. A notch 116 separates the outwardly extending portion 100 and the end 104. The notch 116 may be configured to be at least as large as the axial cross section of axial fastening element 50, as will be discussed in further detail hereinafter.

Turning again to Figure 1, the sleeve 12 includes a plurality of tracks 80-84 to assist for example in the direction of the sleeve 12 during movement. In many arrangements, the tracks are configured to slidably receive guide element 44 of housing 12. Thus, tracks 80-84 may be configured to have a similar cross-sectional shape as guide element 44, for example a generally rectangular, generally T-shaped, circular sector, or the like. For example, the illustrated guide element 44 and tracks 80-84 are generally trapezoidal in cross-sectional shape. A first track 8 0 and a second track 82 are generally parallel to axis 18 and extend along sleeve 12 from proximal end 60 to distant end 62. A spacer 85 separates tracks 80,82 through at least a portion of or most of its length. A separate transfer track 84 can be placed in a middle or intermediate region along the length of the sleeve and at an angle relative to axis 18 (eg, not parallel to axis) and can interrupt separation element 85 e intersect with the first and second tracks 80, 82. The transfer track. 84 it can thus join the first and second tracks 80, 82 to allow the guide element to move between the first and second tracks 80, 82 as will be discussed in further detail hereinafter. Transfer track 84 may be generally straight and non-curvilinear to facilitate uniform travel along transfer track 84. In the illustrated example, the intersection of transfer track 84 is placed around the middle part of sleeve 12 and the intersection of transfer track 84 and the first track 80 is close to the intersection of transfer track 84 and the second track 82. In some embodiments, the length of transfer track 84 may generally be about the same size as the cross section width (diameter) of sleeve 12 and may be substantially smaller than the length of sleeve 12. In the illustrated embodiment, transfer track 84 does not constitute a portion of a continuation of either one or the other of the first and second

<td>tracks 80,</td><td> 82;</td><td>plus</td><td>all right,</td><td>the</td><td>track</td><td>transfer</td><td>84 se</td>

<td>extends to</td><td>the</td><td>far</td><td>so much</td><td>of</td><td>one u</td><td>other or both of</td><td>others</td>

<td>tracks 80,</td><td> 82</td><td colspan="2">at a point</td><td colspan="2">in each</td><td>track 80, 82 which</td><td>this</td>

spacing between the start and end of tracks 80,82 (for example, in an intermediate or middle region of tracks 80,82).

In some embodiments, the first track 80 includes an insert portion 86 remote from the transfer track 84. The insert portion 86 may be configured to be inclined in the proximal direction and terminate on a generally flat face 88 at the intersection of first track 80 and transfer track 84. In certain embodiments, insert portion 86 facilitates mounting of cover 10. For example, during assembly of an arrangement, sleeve 12 is inserted through proximal end 34 of housing 14 and moved remotely. The distal end 62 of the sleeve 12 is mounted such that the guide element 44 is generally aligned with the insertion portion 86 of the first track 80. As the sleeve is moved remotely, the guide element 44 moves or travels up the incline of the insertion potion 86 until it reaches the generally flat face 88, at which point the guide element 44 can be inserted to the bottom of the first track 80. Thereafter, the flat face 88 can inhibit or prevent removal of the cover 10 by presenting a barrier to the guide element 44 that moves distantly along the insertion portion 86. Furthermore, the flat face 88 can direct the guide element 44 from the first track 80 to the transfer track 84 during retraction of the sleeve 12.

Cover 10 can be many different sizes to accommodate various needle sizes and types of insertion and / or removal procedures. For example, the. Cover 10 may be configured to accommodate needles used in medical (including dental) and veterinary procedures. In some embodiments, the cover 10 may have an overall length of at least about 10mm and / or less than or equal to about 100mm, a housing diameter 14 of at least 6mm and / or less than or equal to about of 20 mm and a diameter and sleeve 12 of at least about 3 mm and / or less than or equal to about 18 mm. In some embodiments, sleeve 12 is longer than housing 14, in some embodiments, housing 14 is longer than sleeve 12. Some examples of covers 10 include a housing 14 with a length of around at least about 5 mm and / or less than or equal to about 50 mm and a sleeve with a length of around at least 5 mm and / or less than or equal to about 50 mm. Other arrangements have a housing 14 with a length of at least about 15 mm and / or equal to or less than about 3 mm and a sleeve with a length of about at least about 10 mm and / or less than or equal to to about 4 0 mm. Some modes of the cover are configured for use with 16 needle which have a gauge of at least 7 and / or less than or equal to about

34.

Many modalities of sleeve 12 and housing 14 are configured to provide a variety of potential insertion depths (the maximum penetration distance by needle 16). This can help to treat, for example dissimilar desired insertion depths between various procedures eg, intramuscular versus subcutaneous injections. In some embodiments, the potential insertion depth is determined by the distance the sleeve 12 travels from the fully retracted position (Figure 1) to the fully retracted position (Figure 5). In some embodiments, the potential insertion depth is at least 1mm and / or less than or equal to about 30mm. In another construction, the potential insertion depth is at least 3mm and / or less than or equal to about 70mm. In some embodiments, there is a mechanism to determine the fit and / or vary the potential insert depth. For example, some embodiments include a retainer (not shown) that extends radially inward from the inner surface 22 of housing 14 and coupled to an axially movable ratchet such that proximal end 60 of sleeve 12 is spliced ​​against the retention element when a desired level of depth and insertion is reached. In some embodiments, the cover 10 includes indications, for example a scale printed on the sleeve 12 to indicate the depth and insertion of the needle 16.

The cover 10 and components thereof can be formed using many sufficient manufacturing processes to provide the desired shape of the components. In some embodiments, one or more components are manufactured by a molding process, such as but not limited to injection molding, compression molding, blow molding, transfer molding, or the like. In some embodiments, one or more components are formed · by forging, machining, casting, stamping, extrusion, a combination thereof or the like.

In many embodiments, cover 10 is constructed of a biocompatible material. In some arrangements, one or more of the components of the cover 10 are plastic (for example, polyether ether ketone) or metal (for example, aluminum, titanium, stainless steel or the like). In some embodiments, the housing 14 and / or sleeve 12 are constructed of materials that are translucent, opaque or otherwise optically distorting, such that a portion (such as the tip) or all of the needle 16 is generally not visible to the patient in a typical injection and / or aspiration procedure before, during and / or after the injection and / or aspiration itself. Furthermore, apart from the channel and the openings 49 in the housing 14 for the axial fastening element 50, certain examples of the housing 14 and sleeve 12 are generally or completely enclosed, for example devoid of slots, openings or other holes to prevent a patient observe needle 16. Thus, during an injection and / or aspiration procedure, any portion of the water 16 that does not extend through the channel 26 may be obscured from view by the housing 14 and the sleeve 12 and any portion of the needle 16 that extends into through channel 26 it will be obscured from view because it is inside a bottle or inside the patient. Of course, in some instances, the entire needle 16 may not be fully obscured from view throughout the injection and / or aspiration procedure depending on, among other things, the specific shapes of the distal end 62 of the sleeve 12 and the angle to which needle 16 is inserted into the patient's bottle and / or tissue. Because many people become anxious simply at the sight of a needle, the items described above can significantly reduce the anxiety or fear of the patient and / or the person administering the injection and / or aspiration (who may also be the patient in self-injection case) to provide a more comfortable overall treatment experience.

In some embodiments, the distal end 62 of the sleeve 12 provides a pressure receptor stimulation element. Stimulation of the pressure-receptor nerves in the area of ​​an injection and / or aspiration has been found to compete with or interfere with the estimation of the pain receptor nerves. In many patients, stimulation of the pressure receptor nerves in this way reduces pain perception during needle insertion. 16 Thus, in some constructions, distal end 32 includes a plurality of axially and / or radially extending ribs or projections 130 extending from end 62 and away from channel 16. For example, in some embodiments, ribs or projections are generally arranged in the form of an asterisk centered around opening 28. In use, the projections 130 may be configured to engage with the skin or tissue of a patient just before the tip 46 of the needle 16 contacts the skin or tissue of the patient. In this way, the projections 130 apply pressure to the skin or tissue that stimulates the patient's pressure-receiving nerves before or around the same time as the insertion of the needle 16. In some embodiments, the distal end 62 comprises one or a series of depressions or bumps, such as bumps, cones, rings, or the like, to engage with the patient's skin or tissue and stimulate the patient's pressure receptors prior to insertion of the needle 16. In some arrangements, the distal end 62 of the sleeve 12 is substantially full, beveled, or the like. The specific configuration of the distant end 62 will vary in general depending on, among other things, the proposed field of use for cover 10.

Some arrangements of cover 10 include a therapeutic substance placed at distal end 62. For example, in some embodiments, distal end 62 includes a topical anesthetic. In some embodiments, distant end 62 includes an antiseptic, such as iodine or rubbing alcohol, and / or an antibiotic or antiviral medication. In some embodiments, the therapeutic substance is applied or protected by a cap until cover 10 is to be used.

In certain embodiments, apart from the momentum of the spring 70, the sleeve 12 retracts substantially unimpeded. Cover 10 does not require a first hand to provide pressure and / or to operate the plunger on the syringe and a second hand to operate another element (eg, a fastener). In some embodiments, movement of sleeve 12 automatically engages with one or more of fasteners 50,110. In some embodiments, movement of the sleeve 12 from a fully retracted around position to a fully extended around position automatically prevents or inhibits reuse of the cover 10. Cover 10 may be configured to facilitate one-hand retraction of sleeve 12 (exposed needle 16), one-hand operation of the syringe, one-hand retraction of sleeve 12 (covering needle 16), and / or coupling with one hand of items to inhibit reuse of cover 10. Aside from retracting and / or extending sleeve 12, cover 10 can automatically lock and does not require any external input (eg, from manual manipulation of the user's fingers) to engage with axial fastener 50 and / or the rotational fixing element 110.

In some embodiments, cover 10 is manufactured by forming housing 14 with needle support portion 30, the opening. remote 42 and guide member 44. In embodiments where housing 14 comprises multiple parts, the manufacturing process may include the step of assembling housing 14. A sleeve is formed having tracks 80-84. Guide element 44 is aligned with insertion portion 86 of first track 80. Sleeve 12 is slidably moved through distant opening 42. In some variants, guide member 44 moves upward from tilt at tilt position 86 and inserts into first track 80 around the flat face 88, thereby preventing guide element 44 from returning to insertion portion 86. Needle 16 is coupled with needle support portion 3 0 of housing 14. The spring 16 is inserted into the central chamber 36 of the housing 14 and positioned to drive the sleeve 12.

As shown in Figure 1C and 1F, cover 10 may include a cover 32 that is removably coupled to housing 14. A distant end of cover 34 can be moved between an open position (Figure 1C) and a closed position (Figure ID) by means of a hinge 33. In the closed position, the lid 32 reduces or prevents contamination of the sleeve 12 and the distal end 3 8 of the housing 14, for example during packaging and storage of the cover 10. Cap 32 is generally held in the closed position until just prior to an injection and / or aspiration procedure, at which time cap 32 is moved to the open position and / or removed from housing 14. In some embodiments, the opening or removing cap 32 prior to an injection and / or aspiration procedure does not expose needle 16 because sleeve 12 covers the needle

16. As shown in Figure 1 and 1A. Furthermore, if the cap is removed it can be immediately discarded because the sleeve 12 also covers the needle 16 once the injection and / or aspiration procedure is completed. The lid 32 may include an open position 37 configured to facilitate eg opening and closing the lid.

In some embodiments, the cap may include a movable or removable portion to help properly extract a dose from a bottle. For example, cover 32 may be dimensioned and configured to prevent sleeve 12 from being retracted into housing 14 a sufficient distance that element 44 would enter second track 82 or transfer track 84. In some embodiments, the lid 32 is configured to prevent the sleeve 12 from retracting into the housing 14 far enough to engage with the axial locking element 50 and / or the rotational locking element 110 which may otherwise prevent further use Of the device. In some embodiments, cover 32 limits retraction of sleeve 12 such that guide member 44 remains slidably received on first track 80.

To reduce anxiety, particularly in children, cap 32, housing 14, and / or cuff 12 can be provided with a variety of aesthetic designs, such as rainbows, balloons, cartoon characters, or other illustrations that are generally considered pleasant and comfortable for children. In this way, the child patient can be allowed to choose from a variety of covers 10 prior to the injection and / or aspiration procedure. Cap 32, in addition to or as an alternative to being colored or bearing indications, may be manufactured to resemble a variety of different cartoon characters or other objects, such that, after removal of housing 14 prior to an injection procedure and / or aspiration, cap 32 can be presented to a child patient as a distraction during the injection and / or aspiration procedure. When manufactured to resemble a cartoon character or other object, the overall cylindrical size and shape of the cap 32 make it particularly suitable for use by the child as a stump doll. Each of these elements provides the opportunity to reduce anxiety or fear experienced by many children before, during, and after an injection and / or aspiration procedure.

Figures 1-8A illustrate cover 10 in various positions during an operating cycle proceeding from the initial configuration or extended configuration ready for use to an intermediate position or a fully retracted position shown in Figure 5 or to a final configuration or a extended reuse prevention settings shown in Figure 8A. It should be understood that the following presents an exemplary modality and is not intended to be limiting. It should be further understood that although modality describes needle 16 being used to penetrate the patient's skin, cover 10 is not limited to such use.

Figures 1-1C illustrate cover 10 in initial setup ready for use. As discussed above, cover 10 is attached to a syringe or other medical device, thereby placing the syringe in fluid communication with needle 16. After removing cap 32 (if used) and undertaking surface preparatory steps (if applying a disinfectant to the surface if appropriate) the distal end 62 of cover 10 can be placed against the patient's skin at the site of penetration wanted.

Referring now to Figure 2, cover 10 is illustrated in a first partially retracted configuration. Retraction of the sleeve 12 is generally initiated by a user applying pressure to the cover 10 and / or syringe in the distant direction, which thereby propels the sleeve 12 shortly against the impulse of the spring 70. This retraction of the sleeve 12 to its instead it exposes the distant tip 96 of needle 16 and initiates penetration by needle 16 into the patient's skin. The guide element 44 of the housing 14, which is placed on the first track 80, directs the sleeve 12 to move axially until around the insertion of the first tracks and transfer tracks 80, 84. After reaching the intersection of the first tracks and transfer tracks 80,84, the guide element 44 sits against the flat face 88, which directs the guide element to the transfer track 84. At this stage of the operation, the process can be reversed. If the distant pressure is removed, then the cover 10 can return to the original ready-for-use configuration shown in Figure 1. As shown in Figures 2A, 2B as the sleeve flange 64 moves next, the element Axial clamp 50 passes through notch 116 in flange 64.

In the configuration of Figure 3, the sleeve 12 has been moved further in the near future and the needle 16 has been further exposed. At this point, the sleeve 12 has moved sufficiently close that the proximal portion 90 the channel 26 has begun to receive the needle support portion 30, the axial fastening element 50 has passed through the notches 116 and the flange 64 (Figure 3A) and guide element 44 is placed on transfer track 84. As sleeve 12 moves proximally, guide member 44 passes through transfer track 84, thereby encouraging sleeve 12 to rotate about axis 18 by approximately the number of degrees, for example at least about 5 ° and / or less than or equal to about 90 ° separating the first and second tracks 80, 82. The rotation of the sleeve 12 in turn rotates the flange 64, which includes the impeding element 102. As shown in Figure 3B, the inclined face 106 of the impeding element 102 rotates towards the inclined face 112 of the rotational fastening element 110. Continuous rotation of the impeding element 102 of the flange 64 of the sleeve 12 slidably engages with the inclined faces 106, 112, thereby deflecting the impeding element 102 radially inward and producing slight but noticeable resistance. In some embodiments, as illustrated, the length of the impeding element 102 can generally be about the same size or shorter than the length of the transfer track 84.

Returning to the illustrations in Figures 4 and 4A, sleeve 12 has continued to retract housing 14 which has further exposed needle 16. Guide element 44 has moved from transfer track 84 to second track 82, rotating thus additionally sleeve 12 with respect to housing 14. Needle support portion 30 has been additionally received by proximal portion 90 of channel 26. As shown in Figure 4B, once the inclined face 106 of the impeding element 102 rotates past the zenith of the inclined face 112 of the rotational element 110, the impeding element 102 deflected radially outward thus returning around its position radial shown in Figures 2B. In this configuration, the generally flat faces 108, 114 present a physical obstacle thereby inhibiting counter-rotation of the sleeve 12. This in turn prevents guide element 44 from returning to transfer track 84, as will be discussed hereinafter.

In some embodiments, outward deflection of the impeding element 102 produces a tactile vibration and / or an audible sound, for example a clicking sound that can provide verification that the rotational fixation element 110 has locked and counter-rotation is prevented.

The fully retracted configuration of cover 10 is illustrated in Figure 5.1a needle 16 is at its apex of exposure, presenting the longest exposed needle length. The distal end 62 of the sleeve 12 is generally flush with the distal end 38 of the housing 12. The proximal portion 90 of the channel 26 has fully approached received the needle support portion 30. The spring 70 is generally compressed a its fully compressed configuration. In various embodiments, this is the configuration in which the contents of the syringe are injected, via hub 20 and needle 16, into the patient.

Returning to Figures 6 and 6A, an initial stage of needle extraction 16 is shown. Extraction generally begins when the user pulls the patient's syringe or when the user applies less distant pressure on the cover 10 and / or syringe , thereby allowing the spring 70 to be driven to distinctly extend the sleeve 12. As sleeve 12 extends distantly it receives needle 16 into channel 26, thereby covering at least a portion (such as the far end) of needle 16. The distant movement of sleeve 12 also slides guide element 44 along the second track 82. The engagement of the generally flat faces 108,114 inhibits or prevents counter-rotation of the sleeve 12, which in turn prevents the guide member 44 from moving to the transfer track 84 at the intersection of the second track 82 and the transfer 84.

Figures 7 and 7A illustrate a configuration of cover 10 in which sleeve 12 has been extended further. and needle 16 has been further covered. At this stage in operation, as the sleeve 12 moves distantly, the outwardly extending portion 100 of the flange 64 slidably engages with the axial fastener 50. The outwardly extending portion 100 of the flange 64 encourages the axial fastener 50 radially outward and produces a slight but remarkable strength.

Moving now to Figures 8 and 8A, an extended, reuse-impeding configuration of cover 10 is illustrated. Sleeve 12 has been fully extended and fully covers needle 16. Spring 70 has moved sleeve 12 distantly until the Flange 64 sits against shoulder 40. After the outwardly extending portion 100 of the flange 64 is moved away from the second end 54 of the axial fastening element 50 the axial fastening element 50 inserted radially inward with respect to the outwardly extending portion 100 of the flange 64. The axial fixing element 50 thus presents a physical obstacle to prevent the sleeve 12 from being retracted again soon. In some embodiments, inward deflection of at least one axial clamping element 50 produces a tactile vibration and / or an audible sound, for example clicking that can provide verification that the axial clamping element 50 has been engaged.

Figures 9-14A illustrate another embodiment of the cover.

10. Various elements and components of cover 10a are similar in form and function to those described above with respect to cover 10 and have been provided with similar numbers. To the extent that the components of the cover 10a differ slightly from the cover 10 described above, some of those differences are described and explained below. Any elements and / or components of the disclosed modalities can be combined or used interchangeably.

In the embodiment illustrated in Figures 9-9B, the cover 10a includes a generally cylindrical housing 14a comprising an axis 18a along which a needle 16a is placed. A distal end of housing 14a engages sleeve 12a configured to translate along and rotate at least partially about axis 18a. a proximal end 60a of sleeve 12a engages with a radially outwardly extending flange 64a. a proximal end 34a of housing 14a comprises or is coupled to a hub 20a. An internal surface 22a of housing 14a includes a central chamber 36a. One or more ribs 110a extend radially inward from the inner surface 22a. A distant end 38a of the housing · 14^toit includes a radially inwardly extending shoulder 40a, including an opening 22a communicating with chamber 36a. The opening 42a slidably receives the sleeve 12a which in turn receives and covers the needle 16a. A guide member 44a extends radially inward from shoulder 4 0a and is configured to mate with one or more tracks formed in sleeve 12a.

With continued reference to the illustrations in Figure 9-9B, housing 14a includes at least one axial fastening element 50a. Fixing element 50a can extend generally parallel to axis 18a from inner surface 22a of proximal end 34a of housing 14a to near inner surface 22a of distal end 38a of housing 14a. a portion of the axial fastening element 50a extends approximately parallel to the axis 18a and is configured to avoid interference with a flange 64a of the sleeve 12a as the sleeve 12a moves axially. A second end 54a of axial clamping member 50a is angled radially inward. As shown in Figure 9B, in some arrangements, the second end 54a of the axial fastener 50a aligned with a notch 116a in a flange 64a, thereby allowing the second end 54a to pass through the sample 116a.

Referring to Figures 10-10B, cover 10a is shown in a partially retracted configuration. As discussed above, the guide element 44a soon travels a distance along a track 80a during retraction of the sleeve 12a. The guide element 44a can be directed to a transfer track 84a that intersects the first track 80a and in turn directed to a second track 82a, thereby at least partially rotating the sleeve 12a with respect to the housing 14a. transfer track 84a can be tilted such that there is a height difference between transfer track 84a and second track 82a. Tilting on transfer track 84a can produce slight but noticeable resistance. The guide element 44a can be directed through the height difference and to the second track 82a and can thereby produce an audible or tactile alert. The height difference can prevent or inhibit the guide element 44a from returning to the transfer track 84a and in turn inhibits the rotation of the sleeve 12. In the arrangement shown, as the sleeve 12a rotates, an outwardly extending portion 100a of a flange 64a rotates at radial interference with the second end 54a.

Figures 11 and 11A illustrate cover 10a in a configuration with sleeve 12a fully retracted. The

<td>element</td><td>of</td><td>guide 44a has been directed to and</td><td>traveled</td><td>a</td>

<td>distance</td><td>to</td><td colspan="2">along the second track 82a. how</td><td>I know</td>

<td>shows,</td><td>a</td><td>distant end 62a of the sleeve</td><td>12a this</td><td>in</td>

general leveled 'with the far end 62^to of the accommodation

14 to.

The configurations of cover 10 with sleeve 12a in progressively extended positions are shown in Figures 12-14A. As the predisposition of spring 70a encourages sleeve 12a distantly, guide element 44a in second track 82a prevents or inhibits rotation of sleeve 12a with respect to housing 14a. As stated above, the height difference between the second track 82a and the transfer track 84a can prevent or inhibit the guide element 44a from moving from the second track 82a to the transfer track 84a. As the flange 64a approaches the distal end 38a of the housing 14a the outwardly extending position 100a drives the axial fastening element 50a radially outward, thereby producing slight but noticeable resistance. Once the flange 64a has been moved away from the second end 54a of the axial fastening element 50a the fastening element 50a returns radially inward to its position prior to engagement with the flange 64a. In various embodiments, such movement of the at least one axial fastening member 50a produces a tactile or audible alert. As shown in Figure 14a, the second end 54a of the at least one axial fastening element 50a prevents the outwardly extending portion 100a of the flange 64a from moving soon. Reuse of cover 16a is therefore inhibited or prevented.

Although the needle cover has been disclosed in the context of certain preferred embodiments and examples, it is understood by those skilled in the art that the needle cover extends beyond the embodiments specifically disclosed to other alternative embodiments and / or uses of the invention and obvious and equivalent modifications thereof. For example, the fixation and / or reuse inhibition elements could be used in a variety of medical and non-medical fields. For example, although the sleeve and housing modalities described above are generally circular in axial cross-sectional shape, other sleeve and housing modalities employ various other shapes, such as square, elliptical, hexagonal, or the like. It should be understood that various elements and aspects of the disclosed embodiment can be combined with or replaced by another in order to form variable modes of the needle cover. For example, in some embodiments, the plurality of needles are placed on the inner surface of the housing and are configured to receive the guide member that extends outwardly from the sleeve. Thus, it is intended that the scope of the needle cover disclosed herein should not be limited by the particular disclosed embodiments described above, but should be determined only by a fair reading of the claims that follow.