DESC:FIELD OF THE INVENTION

The present disclosure generally relates to piercing devices. More particularly, the disclosure relates to a piercing device having self-releasing and disposable components, related methods of fabrication and methods of its use. In particularly, the disclosure relates to a piercing device for use to pierce the skin prior to insertion of a jewelry item having enhanced safety features. Piercing for example of human skin involves, not being limited to, piercing of cartilage, eyebrow, earlobe, moroe, tragus, medusa, madonna, ashlay, side labrat, helix, conch, rook etc for wearing a jewelry item.

BACKGROUND OF THE INVENTION

Piercing for example of human skin refers to making a fine hole for example in a lobe of ear for wearing a jewlerey item. It is a commonly known tradition and method and generally done manually inserting a sterilized needle. Post the piercing a lightweight stud earring made of an inert material, such as silver is worn in the pierced ear in order to prevent the closing of the ear. However, the known contemorary methods for such piercing have several disadvantages including being painful, which require experienced handling of the needle and piercing process. Further, such piercings have the risk of having the needle being contaminated during the piercing operation. Also, it is possible that the subsequent process of sterlizing the contaminated needle is not done, it may lead to spreading of diseases to a next user if the same device is reused.

Although a variety of piercing devices are available, a need still exists for a piercing device for use to pierce the skin prior to insertion of a jewelry item having enhanced safety features. While a variety of piercing devices been developed, improvements on the cost, ease of use, improvement and effectiveness of safety feature is a constant need.

Hence, it is desireable to provide a piercing device having self-releasing and disposable components in order to overcome the shortcomings of the prior arts.

SUMMARY AND OBJECTS OF THE INVENTION

A primary object and advantage of the present disclosure is to provide a piercing device having self-releasing and disposable components in order to overcome the shortcomings of the prior arts and having improved safety features having high precision and accuracy in making the piercing.

It is another object of the present disclosure to provide a piercing device which on use produces lesser or negligible pain during the piercing process for example during the piercing of the ear.

It is another object of the present disclosure to provide a piercing device that is simple, safe and easy to use and which makes ear piercing painless, fun, exciting and enjoyable.

It is another object of the present disclosure to provide a piercing device that is simple, safe and easy to use during and post piercing.

It is another object of the present disclosure to provide a piercing device having a self releasing component in the form of a protective sleeve or tube in the piercing and which is safe and disposable. The protective sleeve or tube remains in the piercing hole and which allows wearing and/or changing a jewlery item with ease without any pain or negligible pain. For example, the piercer or end user may insert a jewelry item through said protective sleeve or tube and remove said protective sleeve or tube from the piercing site.

It is another object of the present disclosure to provide a piercing device having a needle having a sharp beveled tip at its distal end that reduces the needle insertion pain during piercing. The sharp atraumatic needle bevel helps in the piercing procedure with minimal end user discomfort or pain.

It is yet another object of the present disclosure to provide protective sleeve or tube having a special tapered tip profile for smooth insertion and to minimize insertion discomfort during piercing. Said protective sleeve or tube being mounted on the needle shaft is provided with at least one cut for self-releasing function. The protective sleeve or tube may be made of a suitable medical-grade plastic, a bicompative material, an inert material, such as nylon, or the like and/or a combination thereof.

A further object of the present disclosure is to provide a piercing device which allows for safer, convenient and more reliable placement of the protective sleeve or tube in the piercing site of the end user, for example pierced hole in the ear lobe of an end user.

It is another object of the present disclosure to provide a compact design for the piercing device and a protective needle cover having improved safety mechanism.

According to an aspect of the present disclosure, there is provided a piercing device comprising: a protective cover; a tube having a proximal end and a distal end mounted to a tube holder; the tube holder having a proximal and a distal end; a needle defining an axial direction (AD) has a wall defining a lumen and having a needle shaft with a needle tip at a distal end and a needle hub mounted to the proximal end of the needle shaft; wherein said needle shaft extends through said tube holder such that said needle tip of said needle protrudes from said distal end of said tube; wherein said tube may be provided with at least one cut closer to the distal end of said tube holder for self release of said tube once the needle is withdrawn post use of said piercing device.

Another aspect of the present disclosure relates to a protective needle cover for a piercing device comprising: a two part assembly having an upper part and a lower part, each of the upper and lower part compising a proximal and a distal end wherein the lower part at it its proximal region has an inner space forming an enclosure including a dimension.

In some examples, the cut in the tube may be provided closest to the tube holder being distant from the distal tip end of the needle shaft.

In some examples, a proximal end of the tube may be joined with the tube holder having at least one cut being closest to the tube holder and wherein said cut being arranged distant from the distal tip end of the needle shaft.

In some examples, the length of the tube after the cutting may be at least more than 10% of the length of the needle shaft.

In some examples, the length of the tube after the cutting may be at least more than 25% of the length of the needle shaft.

In some examples, the distal end of the tube may include a tapered tip profile being in conformity with the bevelled tip of the needle shaft for smooth insertion and to minimize insertion discomfort during piercing.

In some examples, the tube may be shaped to grip the needle tightly being mounted on the needle shaft in the ready position having a clost fit ratio between the inner diameter of the tube and outer diameter of the needle shaft. The close fit ratio arrangment includes, not being limited to, a gap between the inner diameter of the tube and outer diameter of the needle shaft of not more than 25 – 30%.

In some examples, the tube holder and needle hub may be glued being joined with each other having a unibody structure so that once the needle is withdrwan both comes jointly out of the tube. The tube holder and needle hub may be joined together by any suitable means and methods including, but not limited to, through press fit, adhesive bonding, friction fit, glue, resins, welding (laser, spot, etc.), soldering, chemical bonding materials or combinations thereof.

In some examples, the needle may be connected in a leak free manner for example, glued, to the needle hub. The distal end of the needle is beveled to define a sharp puncture tip. The sharp beveled puncture tip is provided for insertion into an end user‘s skin for example, earlobe and is therefore designed to provide ease of insertion and minimal discomfort during piercing.

In some examples, the proximal end of the tube holder comprises a coupling member and the distal mating end of the needle hub comprises a coupling member, wherein the coupling member(s) of the tube holder and needle hub being complementary to hold the tube holder and needle hub together, in particualrly in a ready position.

In some examples, the tube holder may be engageably attached to the needle hub having one or more engaging elements configured to restrict the rotation of the tube holder and in turn of the needle with respect to the needle hub. The needle hub may comprise a corresponding safety anti-rotation element configured to engage the tube holder engaging element. The tube holder may be snap fitted with the needle hub. The snap fit may be formed by the engaging element comprising a needle hub having a peripheral wall projecting from a distal surface. The peripheral wall of the needle hub may comprise at least one slit or recess, which passes through the thickness of the distal surface. The tube holder may have at least one lateral protrusion from edge of the proximal surface configured to be received by the slit or recess within the needle hub forming a snap fit arrangement. The lateral protrusion may support the holding of the tube holder with the needle hub. Thus, the tube holder may be snap fitted with the needle hub. The snap-fit may be formed by a protrusion and a corresponding recess which may be provided in both needle hub and tube holder alternatively. Other ways and means for a secure engagement between the tube holder and needle hub are also encompassed herein.

In some examples, the upper and lower part of the protective needle cover may be releasably attached with each other.

In some examples, the upper part of the protective needle cover comprises a generally tubular profile including a tubular housing with an inner space having a dimension providing a protective cover for the needle shaft and the sharp needle tip.

In some examples, the distal end of the lower part of the protective needle cover comprises a slightly smaller outer profile corresponding with an inner profile of the proximal end of the upper part of the protective needle cover.

In some examples, the dimension of the inner space of the lower part at the proximal end section of the protective needle cover may be bigger/larger in size in comparison to the dimension of the inner space at the distal end section of the lower part of the protective cover.

In some examples, the distal most end of the upper part of the protective needle cover comprises a cut profile including a cut with a radius at an angle forming a slanted cut profile, whereas the proximal most end of the upper part comprises a cut profile including a radius.

In some examples, the upper part integrally joined with the lower part through a breakable feature and/or breakable portion. The breakable feature and/or breakable portion may be integrally constructed in an area adjoining a proximal most end portion of the upper part and a distal most end portion of the lower part.

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS:

The foregoing and other objects, features, and advantages of the present disclosure will be apparent from the following detailed description taken in conjunction with the accompanying drawings, wherein:

Fig. 1A illustrates an overall view of a piercing device having a needle cover according to the present disclosure.

Figs. 1B & 1C illustrate an overall view showing left and right sides of the piercing device of Fig. 1A respectively with a needle cover according to the present disclosure.

Fig. 1D illustrates a cross-sectional view of the piercing device according to Fig. 1C.

Fig. 2 illustrates an overall view of the piercing device of Fig. 1A without a needle cover in a ready to use state according to the present disclosure.

Fig. 3 illustrates an exploded view of the piercing device showing a protective sleeve or tube with at least one cut for self-releasing function according to the present disclosure.

Figs. 4A, 4B & 4C illustrate a front view and cross-sectional view(s) respectively of the protective needle cover according to an aspect of the present disclosure.

Figs. 4D & 4E illustrate exploded views of the protective needle cover of Figs. 4A, 4B & 4C.

Figs. 5A, 5B & 5C illustrate a front view, a cross-sectional front view and a cross-sectional side view respectively of the piercing device with the protective needle cover of Figs. 4A, 4B & 4C.

Figs. 6A, 6B & 6C illustrate a perspective view, a front view and a cross-sectional view respectively of the protective needle cover according to another aspect of the present disclosure.

Figs. 7A & 7B illustrate a front view and a cross-sectional view respectively of the piercing device with the protective needle cover of Figs. 6A, 6B & 6C.

DETAILED DESCRIPTION OF THE INVENTION

Aspects of the presently disclosed disclosure will now be described in detail with reference to the drawings wherein like reference numerals designate identical or corresponding elements. In the drawings and in the description, the term "proximal", "bottom", "down" or "lower" refers to a location on the device that is closest to a user using the device and farthest from an end user i.e. who is being pierced by the piercing device i.e. in connection with whom the device is used when the device is used in its normal operation. Conversely, the term "distal", "top", "up" or "upper" refers to a location on the device that is farthest from the clinician using the device and closest to the patient in connection with whom the device is used when the device is used in its normal operation. For example, the distal region of a needle will be the region of the needle containing the needle tip which is to be inserted e.g. into an end user’s earlobe.

As used herein, the term distal end or proximal end means an end in a distal general location or proximal general location, respectively, or distal most end or proximal most end, respectively. If only a distal most end or a proximal most end is intended, the text will indicate.

As used herein, the terms first, second, third, etc. are understood to describe different structures/elements so as to distinguish one from another. However, the terms are not structurally limiting unless the context indicates otherwise.

The term "substantially" means that the recited characteristic, parameter, or value need not be achieved exactly, but that deviations or variations, including for example, tolerances, measurement error, measurement accuracy limitations and other factors known to those of skill in the art, may occur in amounts that do not preclude the effect the characteristic was intended to provide.

Moreover, the Figures may show simplified or partial views, and the dimensions of elements in the Figures may be exaggerated or otherwise not in proportion for clarity. In addition, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to a terminal includes reference to one or more terminals. In addition, where reference is made to a list of elements (e.g., elements a, b, c), such reference is intended to include any one of the listed elements by itself, any combination of less than all of the listed elements, and/or a combination of all of the listed elements.

As used herein “ready to use state” or “ready position” means the piercing device is ready for use, such as to perform a piercing. Sometimes the ready position first requires removing a protective cap from the piercing device or piercing device needle assembly. The protective cap usually covers the needle assembly of the piercing device and included with the packaging of the piercing device.

As used herein “post use state” or “post use position” means and include that the piercing device has been used for piercing deploying automatically the self-releasing function of the protective sleeve or tube and in particular that the needle hub having a needle is ready for safe disposal.

Referring to Fig. 1A an overall view of a piercing device assembly 10 according to the present disclosure is shown comprising a protective needle cover 12 which may be releasably attached to a needle hub 22. Reference is further made to Figs. 1B and 1C. The protective cover 12 may be formed of a plastic or metal or other suitable material and has inner space in order to cover protect the needle hub assembly 14 of the piercing device 10. The protective cover 12 may be made of a material being tranparent. Alternatively, the protective cover 12 may also be made of a material being non-transparent.

In various aspects of the present disclosure, the protective cover 12 defines inner space. Further, the protective cover 12 has inner and outer periphery at its proximal end including one or more locking features. As such, the outer periphery and/or inner periphery of the protective cover 12 body at its proximal end may be provided with such locking features including one or more luer threads or locking elements or the like in any number of thread configurations available to provide and interlock between the protective cover 12 and needle hub 14, in particularly at the distal end of the needle hub 14 having a snap fit locking arrangement. The inner space of the protective cover 12 in its proximal region including a dimension being larger than the outer profiles of the tube holder assembly 16 and needle hub assembly 14.

The dimension of the inner space at the proximal end section may be bigger in size in comparison to the dimension of the inner space at the distal end section of the protective cover 12. The advantage of change in dimension of inner space lies in the fact that inner space at the proximal end section of the protective cover 12 is dimensioned very precisely in order to ensure an inner space with a well-controlled and large enough diameter such that to safely house a tube holder assembly 16 of the piercing device in a ready to use state. The tube holder assembly 16 having a protective sleeve or tube 18 with at least one cut 28 for self-releasing function. The tube holder 16 may be engageably attached to the needle hub 14 prior to use of the device 10 in ready position as shown in Fig 2.

Referring now to Fig. 2, it illustrates an overall view of the piercing device 10 of Fig. 1A without a needle cover 12 in a ready to use state according to the present disclosure. Reference is also made to Fig. 1D. As shown, the piercing device 10 comprises a needle hub 14 having a needle 20 fixedly attached therewith extending in an axial direction AD. The piercing device 10 further comprises a tube holder 16 having a chamber 26 and a tube 18 being received on the needle 20 at a distal end of the tube holder 16. The needle 20 having distal and proximal ends extends through the chamber 26 of the tube holder 16 as well as through the tube 18. The needle 20 comprises a needle shaft 22 and a needle tip 24 at its distal end. The needle shaft 22 has a generally constant pricipal outer profile.

As stated above, Fig. 2 illustrates the piercing device in a ready to use state i.e. in a condition prior to use. In this condition prior to use the needle 20 extends all the way through the chamber 26 of the tube holder 16 as well as the tube 18 such that the needle tip 24 protrudes from a distal end of the tube 18. This position of the needle tip 24 is also referred to as the ready position in this context. It is to be noted that needle 20 may be fixed in its ready position by the needle hub 14 engaging with the tube holder 16. The tube holder 16 may be engageably attached to the needle hub 14 prior to use of the device 10 in ready position as shown in Fig. 2.

Reference is further made to Fig. 3 which shows an exploded view with the components described above, which however is not a condition of use. This exploded view rather shows the way, how the piercing device according to the disclosure may be assembled.

As shown in Figs. 1D, 2 and 3, the piercing device 10 comprises: a protective cover 12; a tube 18 having a proximal end and a distal end mounted to a tube holder 16; the tube holder 16 having a proximal and a distal end; a needle 20 defining an axial direction (AD) has a wall defining a lumen, a bevel and having a needle shaft 22 with a needle tip 24 at a distal end and a needle hub 14 mounted to the proximal end of the needle shaft 22; wherein said needle shaft 22 extends through said tube holder 16 such that said needle tip 24 of said needle 20 protrudes from said distal end of said tube 18; wherein said tube 18 may be provided with at least one cut 28 closer to the distal end of said tube holder 16 for self release of said tube 18 once the needle 20 is withdrawn post use of the piercing device 10. The cut 28 in the tube 18 may be provided closest to the tube holder 16 being distant from the distal tip 24 end of the needle shaft 22. Further, the distal end of the tube 18 having a tapered tip profile being in conformity with the bevelled tip 24 of the needle shaft 22 for smooth insertion and to minimize insertion discomfort during piercing.

The tube 18 may be shaped to grip the needle 20 tightly being mounted on the needle shaft 22 in the ready position having a clost fit ratio between the inner diameter of the tube 18 and outer diameter of the needle shaft 22. The close fit ratio arrangment includes, not being limited to, a gap between the inner diameter of the tube 18 and outer diameter of the needle shaft 22 of not more than 25 – 30%.

The needle 20 may be connected in a leak free manner for example, glued or press fitted, to the needle hub 14. The distal end of the needle 20 may be beveled to define a sharp puncture tip 24. The sharp beveled puncture tip 24 is provided for insertion into an end user‘s skin for example, earlobe and is therefore designed to provide ease of insertion and minimal discomfort during piercing. Whereas, the proximal end of the needle 20 may be attached to the needle hub 14 which acts as a control end. The control end of device 10 comes handy during use of the piercing device and during the withdrawl needle 20 post succesful piercing. As such, the control end generally ends in the form of a handle having one or more finger grips 40 or other operating portion for maneuvering device 10. Handle part of the needle hub 14 may be any of a variety of forms or structures suitable for use in conjunction with needles or medical devices.

Referring now to the locking arrangement between the tube holder 16 and the needle hub 14 comprising at least one tube holder 16 engaging element configured to restrict the rotation of the tube holder 16 and in turn of the needle 20 with respect to the needle hub 14. The needle hub 14 may be provided with a corresponding safety anti-rotation element configured to engage the tube holder 16 engaging element. As shown in Fig. 2, the tube holder 16 may be snap fitted with the needle hub 14 including a provision of separation force greater than at least 0.1 N required to detach them separately from each other. The snap fit may be formed by the engaging element comprising the needle hub 14 having a peripheral wall 30 projecting from a distal surface 32 of the needle hub 14. The peripheral wall 30 of the needle hub 14 comprises at least one slit or recess 34, which passes through the thickness of the distal surface 32. The tube holder 16 may be provided with at least one lateral protrusion 36 from edge of a proximal surface 38 configured to be received by the slit or recess 34 within the needle hub 14 forming a snap fit arrangement. The lateral protrusion 36 supports the holding of the tube holder 16 with the needle hub 14. Thus, the tube holder 16 may be snap fitted with the needle hub 14. The snap-fit may also be formed by a protrusion and a corresponding recess which may be provided in both needle hub 14 and tube holder 16 alternatively.

Alternative arrangements by way of replacing the change of dimensions outside the tube holder 16 at the proximal end thereof and on the distal surface 32 or upper part of the needle hub 14 may also be employed. For example, the upper part of the needle hub 14 may be made with a fitment and be snap-fitted with the tube holder 16. The snap-fit may be further formed by a protrusion ring and a corresponding groove ring. The protrusion ring may comprise the groove and the groove ring may comprise at least one projection or vice versa. The ring of both the projections or groove may be a continuous ring or a spaced apart formation. Other known ways and means for a secure engagement(s) of the tube holder 16 and needle hub 14 are also encompassed herein.

Both the tube holder 16 and needle hub 14 have a substantially cylindrical shape, which is structurally beneficial to the provision of rotation capabilities. The tube holder 16 may have other geometrical shapes with inner space forming the chamber 26 which in alternative aspects can be used to house a needle tip proctor (not shown). Likewise, needle hub 14 may have other geometrical shapes other than cylindrical shape. The outer surface of both the tube holder 16 and needle hub 14 may be provided with one or more finger grips 40 for ease of handling, activation and easy movement and better grip. The finger grips 40, not being limited to, may have a variety of designs and configurations in alternative aspects.

Both the tube holder 16 and needle hub 14 are made of plastic material including, not being limited to, PP, ABS, PC, PE or glass or a combination thereof having transparent and/or non-transparent qualities/features for visibility and designed with ergonomic feel for better control and ease of handling. Alternatively, both the tube holder 16 and needle hub 14 may be made being non-transparent.

The needle 20 may be made of a metal, a metal alloy, or any other material suitable for medical use/purpose and meeting the safety standards and requirements.

In operation of using the piercing device 10, the detachable protective needle cover 12 may be detached exposing the sharp beveled needle tip 24. Therafter, a piercing site for example, an ear lobe of a person having such a piercing can be cleaned and marked for piercing. Thereafter, the disclosed piercing device 10 can be positioned on the ear lobe with the needle 20 aligned to the marked piercing point wherein the piercer i.e. the person doing the person holds the earlobe by one hand and thereafter using his other hand, the marked point is pressed through the beveled needle tip 24 which drives the sharp needle tip 24 together with the tube 18 mounted thereon through the ear lobe resulting in the piercing of the earlobe.

Post such puncture, the needle 20 is withdrawn and at this point the needle is removed from the earlobe leaving the tube 18 in the pierced hole of the earlobe. The tube 18 remains in the pierced hole and which allows wearing and/or changing a jewlery item with ease without any pain or negligible pain. For example, the piercer or end user may insert a jewelry item through said tube 18 and remove said tube 18 from the pierced site. Thereafter, the tube 18 and the needle portion of the piercing device 10 can be safely disposed of. In this process, the tube 18 gets separated from the piercing device 10 i.e. from the tube holder 16 and retained on the ear lobe. The tube 18 through cut 28 is removably coupled to the needle 20 and gets separated from the needle 20 when the piercing device 10 is removed from the ear lobe.

The tube 18 having a hollow construction i.e. the tube 18 is hollow such as a jewelry item for example, an earring can be worn in the tube 18, wherein the post of the earring can easily pass through the tube 18. After the healing process, the tube 18 can be removed, and the tube extracted and discarded or be safely disposed, leaving the pierced ear open for normal earring wear.

Referring to Figs. 4A, 4B & 4C, a front view and cross-sectional view(s) respectively of the protective needle cover 12 according to one aspect of the present disclosure are illustrated. The protective needle cover 12 includes a two part assembly having an upper part 42 and a lower part 44. The upper part 42 and the lower part 44 are configured to be releasably attached with each other including a provision of separation force greater than at least 0.1 N required to detach them separately from each other. Each of the upper 42 and lower 44 part compising a proximal 46 and a distal end 48.

The combination of the upper 42 and lower part 44 of the protective needle cover 12 may be configured to be releasably attached to a needle hub 14 of the piercing device 10 as shown in Figs. 5A, 5B & 5C. The lower part 44 at its proximal region has an inner space forming an enclosure 50 including a dimension being larger than the outer profiles of the tube holder assembly 16 and needle hub assembly 14 (as shown in Figs. 5B & 5C). The encloure 50 as shown, not being limited to, comprising a box shape having an opening at proximal most end running through in axial direction AD until the distal most end of the upper part 42 may be covered from all four sides. In alternative emodiment, the enclosure 52 having an opening at proximal most end may be covered only from three sides including at least one uncovered side exposing the tube holder assembly 16 from said one uncovered side being retained within the enclosure 50 in the ready position. The enclosure 50, not being limited to, may have a variety of shapes, designs and configurations in alternative aspects.

The upper part 42 comprises a generally tubular profile with an inner space having a dimension providing a protective cover for the needle shaft 22 and the sharp needle tip 24.

Futher, the dimension of the inner space of the lower part 44 at the proximal end section may be bigger/larger in size in comparison to the dimension of the inner space at the distal end section of the lower part 44 of the protective cover 12. The distal end 48 of the lower part 44 comprises a slightly smaller outer profile corresponding with an inner profile of the proximal end of the upper part 42 of the protective needle cover 12. The slightly smaller outer profile at the distal end 48 of the lower part 44 may be releasably attached through a snap fit with the inner profile of the proximal end of the upper part 42 in a firm manner and may be detached from the upper part 42 or the lower part 44 may be detached from the upper part 42 by use of force.

The distal most end of the upper part 42 comprises a cut profile 54 including a cut with a radius at an angle forming a slanted cut profile. In alternative aspect, the cut profile 54 at the distal most end of the upper part 42 may be without any angle. The slanted cut profile 54 facilitates supporting the piercing area for example, an ear lobe during piercing. As such, during piercing of an ear lobe, holding the upper part 42 in one hand, the slanted cut profile 54 of the upper part 42 may be used to support the rear of the ear lobe while piercing the front of the ear lobe through the sharp tip 24 of the needle 20. Such a use and arrangement provide an additional protective feature in that post successful piercing, the sharp tip 24 of the needle 20 is safely received within the tubular housing of the upper part 42 through the slanted cut profile 54 preventing any injury to the end user from the sharp tip 24 of the piercing device 10.

Likewise, the proximal most end of the upper part 42 once separated from the lower part 44 as shown in Figs. 4D and 4E comprises a cut profile 54 including a radius for smooth support at body part such as outer conch, industrial, helix, sung, tragus, side lip, ashley, eyebrow etc. of a user going through piercing activity. Thus, the proximal most end of the upper part 42 may also be used for such protective piercing similar as slated cut profile 54 discussed above.

The use during piercing of the upper part 42 may be not limited only to the use of slanted cut profile or cut profile 54 for a protective piercing and the entire upper part 42 or any other part/portion thereof may be used for a protective piercing of the end user.

In a similar manner, the distal end 48 or proximal end 50 or any part/portion of the lower part 44 may be used for protective piercing of the end user.

Referring now to Figs. 6A, 6B & 6C, a perspective view, a front view and a cross-sectional view respectively of the protective needle cover 12 according to another aspect of the present disclosure are illustrated. Being similar to the aspect of the protective needle cover 12 as shown in Figs. 4A, 4B & 4C, this alternative aspect includes a distinguishing feature in that the upper part 42 may be integrally joined with the lower part 44 of the protective needle cover through a breakable feature and/or breakable portion 56 provided in an area joining the upper 42 and lower part 44. According to an aspect of the present disclosure, the breakable feature and/or breakable portion 56 may be constructed and arranged to break at a force and/or to break at a predetermined threshold. As can be seen in Figs. 6A, 6B & 6C, the breakable feature and/or breakable portion 56 may be integrally constructed in an area adjoining a proximal most end portion of the upper part 42 and a distal most end portion of the lower part 44. The breakable feature and/or breakable portion 56 in alternative aspects can be located in other part/portion of the protective needle cover 12. As per the need during the piercing, the upper part 42 and the lower part 44 may be pulled apart or tilted using force causing the breakable feature and/or breakable portion 56 to break separating the upper 42 and lower part 44 of the protective needle cover 12.

In one of the aspects, the needle 20 having a sharp tip 24 post use is protected by a needle tip protector (not shown) which may be slidably arranged on the needle shaft 22 and housed in the chamber 26 of the tube holder 16, wherein the needle tip protector may include a base portion made of a first material and having a needle passage which extends in an axial direction AD from a proximal side of the base portion through the base portion to a distal side of the base portion, such that a needle 20 having a principal outer profile may be movably arranged in the needle passage. The needle tip protector further includes first and second arms extending substantially in the axial direction from the distal side of the base portion, with the first arm having a distal region and a proximal region. A distal wall may be transversely arranged in the distal region of the first arm. The distal wall is having a length and width much bigger than the outer diameter of the needle such that it completely covers and blocks the needle tip in protected position and/or post use position removing chances of accidental needle pricks.

The needle tip protector may also include a stopping element which may be slidably arranged on the needle shaft and movable relative to the base portion. The stopping element may be adapted to engage with an enlargement of the needle shaft 22 on its one side and with the base portion on its opposite side and, thus, effectively helps to prevent the needle tip protector from sliding beyond the needle tip 24, i.e. from being separated from the needle 20.

According to an aspect of the present disclosure, the stopping element completely surrounds the needle 20. The length of the stopping element, i.e. its dimension seen in the axial direction, may vary. As such, the stopping element may, for example, be a disk, a ring, or a tube. According to an alternative aspect, it is also possible that the stopping element only partly surrounds the needle. In this case, the stopping element could have the shape of a slotted disk, ring, or tube. Furthermore, it has to be understood that outer the stopping element does not have to have a circular outer profile. It is also possible that the outer profile of the stopping element may be of non-circular form, for example, of oval or polygonal shape.

According to an aspect of the present disclosure, the stopping element may be arranged in the base portion. For example, the stopping element may be arranged in a cavity or cut out provided in the base portion. Alternatively, the stopping element may be arranged anywhere between the first and second arms.

According to a further aspect of the present disclosure, the stopping element may be made of a second material different from the first material. Preferably, the second material may be of greater hardness and/or stiffness than the first material. For example, the first material could be a plastic material and the second material could consist of a metal, a ceramic or a rubber material, or any other type of material which is stiff and not as easily distorted as the first material. According to a further aspect of the present disclosure, the stopping element may be made of material being same as the material of the base portion.

Prior to the use of device 10, the needle tip protector may be arranged in chamber 26 of the tube holder 16 which may be snap fitted with the needle hub 14. In this situation, the needle 20 extends completely through the needle tip protector, thereby deflecting the first arm of the needle tip protector outwards, i.e. at an angle to the axial direction AD, such that the distal wall of the first arm may be supported on the needle shaft 22. Following the piercing of the needle 20 into an end user for example, his/her earlobe and subsequently when the needle 20 is withdrawn from the end user and the needle shaft 22 moves through the needle tip protector while the needle tip protector is retained in the chamber 26 of the tube holder 16. Once the needle tip 24 passes the transverse distal wall of the needle tip protector, i.e. such that the needle shaft 22 no longer supports the distal wall, a restoring force ensures that the first arm of the needle tip protector is moved back into alignment with the axial direction AD of the needle tip protector, so that the needle tip is blocked by the distal wall of the needle tip protector, i.e. the needle tip is prevented from axially projecting out of the needle tip protector.

To explain further, the first arm of the needle tip protector which may be housed in the chamber 26 of the tube holder assembly 16 may be longer than the second arm and has a massive distal wall with a dimension being larger/greater than the diameter of the outer profile of the needle shaft. In alternative aspects, both the first and second arm may include a distal wall. The distal wall includes an undercut for catching the needle tip 24. The distal wall may be arranged at a distal end of the first arm and extends in a direction transverse to an axial direction AD of the needle 20 such that the distal wall completely blocks the needle. The distal wall ensures that the needle tip is always blocked from axially projecting out or sideways projecting out of the needle tip protector. The distal wall has a bigger dimension than the distal surface of the second arm and much bigger dimension than the outer diameter of the needle 20 such that the distal wall completely covers and blocks the needle tip 20 once confined and entrapped within the needle tip protector. The first and second arms of the needle tip protector extend generally in the axial direction AD from a distal side of the base portion, i.e. generally parallel to the needle shaft 22.

In a further aspect of the needle tip protector, a tension element (not shown) may surround the first and second arms of the needle tip protector. In the deflected state of the first arm, the tension element may be expanded against a restoring force of the tension element. In the alternative aspect, the needle tip protector may be without any elastic element.

The tension element, for example, a rubber band or the like, surrounds the first and second arms. The tension element may at least partly surround the first and second arms by a linear biasing action. Alternatively, or additionally, the first and second arms may be made of a resilient material having elastic properties. The restoring force may be created by at least one of an inherent elastic property of any of the first and second arms.

The construction and shape of the improved piercing device 10 according to the various aspects of the present disclosure provides a simple configuration. The simple and compact design of the piercing device 10 according to the above disclosure is advantageous in a clinical setting because it smoothens the whole process thereby reducing injury or discomfort to an end user and provides better safety features and painless piercing experience. In addition, such a design greatly reduces manufacturing costs and is efficient, effective and simple in its construction and use.

It is readily understood by those of skill in the art that the above advantageous aspects may be freely combined and superimposed without conflict.

The foregoing disclosure above are merely preferred aspects of the present disclosure, and are not intended to limit the present disclosure. Any modifications, equivalent substitutions and improvements made without departing from the spirit and principle of the present disclosure should be included in the protection scope of the present disclosure. The foregoing described above are merely preferred aspects of the present disclosure. It should be noted that a number of improvements and variations may be made by those of ordinary skill in the art, without departing from the technical principles of the present disclosure, and such improvements and variations should also be considered to fall within the protection scope of the present disclosure.

List of Reference numerals:

10 piercing device /assembly
12 protective needle cover
14 needle hub/needle hub assembly
16 tube holder/tube holder assembly
18 tube/sleeve
20 needle
22 needle shaft
24 needle tip/sharp tip/beveled tip
26 chamber
28 cut
30 peripheral wall
32 distal surface
34 slit/recess
36 lateral protrusion
38 proximal surface
40 finger grips
42 upper part
44 lower part
46 proximal end
48 distal end
50 enclosure
52 opening
54 cut profile
56 breakable feature/breakable portion
AD axial direction
,CLAIMS:WE CLAIM:

1. A piercing device (10) having self-releasing and disposable component(s) comprising: a protective cover (12), a tube (18) having a proximal end and a distal end mounted to a tube holder (16); the tube holder (16) having a proximal and a distal end; a needle (20) defining an axial direction (AD) having a wall defining a lumen, and having a needle shaft (22) with a needle tip (24) at a distal end thereof; and a needle hub (14) mounted to a proximal end of the needle shaft (22); wherein said needle shaft (22) extends through said tube holder (16) such that said needle tip (24) of said needle (20) protrudes from said distal end of said tube (18); wherein said tube (18) is provided with at least one cut (28) closer to the distal end of said tube holder (16) for self release of said tube (18) once the needle (20) is withdrawn post use of said piercing device (10).

2. The piercing device (10) as claimed in claim 1, wherein the cut (28) in the tube (18) provided closest to the tube holder (16) being distant from the distal tip end (24) of the needle shaft (22) having a length with generally constant pricipal outer profile.

3. The piercing device (10) as claimed in claim 1, wherein a proximal end of the tube (18) joined with the tube holder (16) having at least one cut (28) being closest to the tube holder (16) and wherein said cut (28) being arranged distant from the distal tip end (24) of the needle shaft (22).

4. The piercing device (10) as claimed in any of the preceding claims, wherein tube (18) having a length after the cutting being at least more than 10% of the length of the needle shaft (22).

5. The piercing device (10) as claimed in any of the preceding claims, wherein tube (18) having a length after the cutting being at least more than 25% of the length of the needle shaft (22).

6. The piercing device (10) as claimed in claim 1, wherein the needle having a sharp beveled tip (24) at its distal end that reduces the needle insertion pain during piercing.

7. The piercing device (10) as claimed in any of the precding claims, wherein the distal end of the tube (18) having a tapered tip profile being in conformity with the bevelled tip (24) of the needle shaft (22) for smooth insertion and to minimize insertion discomfort during piercing.

8. The piercing device (10) as claimed in any of the precding claims, wherein the tube (18) shaped to grip the needle (20) tightly being mounted on the needle shaft (22) in a ready position having a clost fit ratio between the inner diameter of the tube (18) and outer diameter of the needle shaft (22).

9. The piercing device (10) as claimed in claim 8, wherein the close fit ratio arrangment includes a gap between the inner diameter of the tube (18) and outer diameter of the needle shaft (22) being in a range of 25 – 30%.

10. The piercing device (10) as claimed in any of the precding claims, wherein the tube holder (16) and needle hub (14) are glued being joined with each other having a unibody structure so that once the needle (20) is withdrwan both comes jointly out of the tube (18).

11. The piercing device (10) as claimed in claim 10, wherein the tube holder (16) and needle hub (14) joined together by any suitable means and methods including, but not limited to, through press fit, adhesive bonding, friction fit, glue, resins, welding (laser, spot, etc.), soldering, chemical bonding materials or combinations thereof.

12. The piercing device (10) as claimed in claim 1, wherein said tube (18) made of a suitable medical-grade plastic, a bicompative material, an inert material, such as nylon or the like and/or a combination thereof.

13. The piercing device (10) as claimed in claim 1, wherein the proximal end of the tube holder (16) comprises a coupling member and the distal mating end of the needle hub (14) comprises a coupling member, wherein the coupling member(s) of the tube holder (16) and needle hub (14) being complementary to hold the tube holder (16) and needle hub (14) together, in particualrly in a ready position.

14. The piercing device (10) as claimed in claim 1, wherein the tube holder (16) having a chamber (26) and the tube (18) being received on the needle (20) at a distal end of the tube holder (16) such that the needle (20) having distal and proximal ends extends through the chamber (26) of the tube holder (16) as well as through the tube (18).

15. The piercing device (10) as claimed in claim 1, wherein both the tube holder (16) and needle hub (14) at its outer surface provided with one or more finger grips (40) for ease of handling, activation and easy movement and better grip.

16. The piercing device (10) as claimed in claim 1, wherein both the tube holder (16) and needle hub (14) made of plastic material including, not being limited to, PP, ABS, PC, PE or glass or a combination thereof having transparent and/or non-transparent qualities/features for visibility and designed with ergonomic feel for better control and ease of handling.

17. The piercing device (10) as claimed in claim 1, wherein the needle hub (14) provided with a filter assembly having one or more filter member(s) wherein said filter member being permeable to air but impermeable to fluid/solution.

18. A protective needle cover (12) for a piercing device (10) comprising: a two part assembly having an upper part (42) and a lower part (44), each of the upper (42) and lower (44) part compising a proximal (46) and a distal end (48) wherein the lower part (44) at it its proximal region has an inner space forming an enclosure (50) including a dimension.

19. The protective needle cover (12) as claimed in claim 18, wherein the upper (42) and lower (44) part releasably attached with each other.

20. The protective needle cover (12) as claimed in claim 18, wherein the upper part (42) comprises a generally tubular profile including a tubular housing with an inner space having a dimension providing a protective cover for the needle shaft (22) and the sharp needle tip (24).

21. The protective needle cover (12) as claimed in any of the preceding claims, wherein the distal end (48) of the lower part (44) comprises a slightly smaller outer profile corresponding with an inner profile of the proximal end of the upper part (42) of the protective needle cover (12).

22. The protective needle cover (12) as claimed in any of the preceding claims, wherein the dimension of the inner space of the lower part (44) at the proximal end section bigger/larger in size in comparison to the dimension of the inner space at the distal end section of the lower part (44) of the protective cover (12).

23. The protective needle cover (12) as claimed in any of the preceding claims, wherein the distal most end of the upper part (42) comprises a cut profile (54) including a cut with a radius at an angle forming a slanted cut profile, whereas the proximal most end of the upper part (42) comprises a cut profile (54) including a radius.

24. The protective needle cover (12) as claimed in any of the preceding claims, wherein the upper part (42) integrally joined with the lower part (44) through a breakable feature and/or breakable portion (56).

25. The protective needle cover (12) as claimed in any of the preceding claims, wherein the breakable feature and/or breakable portion (56) integrally constructed in an area adjoining a proximal most end portion of the upper part (42) and a distal most end portion of the lower part (44).

Dated this 3rd day of March, 2023.