Patent Description:
A Huber needle assembly is generally known in the art. Conventional Huber needle assemblies are widely used in hospitals and are often used in conjunction with implanted ports mostly used to treat hematology and oncology patients. Such Huber needle assemblies provide non-coring Huber needles that are used to administer chemotherapy, IV fluids, medications, total parenteral nutrition, or to transfuse blood products through the implanted ports. The implanted port contains a self-sealing septum that seals around the non-coring needle, holds the needle in place, and allows for multiple accesses by a Huber needle.

<CIT> discloses a huber needle assembly for a medical conduit comprising a base, a needle hub pivotally connected to the base, and a huber needle that passes through the base of the device when the needle hub rests on the base. The needle hub and the base are connected by a two-part connector, wherein the parts of the connector can slide into each other. The connection between the base and the connector is rigid.

<CIT> discloses a further huber needle assembly comprising a base, a needle hub pivotally connected to the base, and a huber needle that passes through the base of the device when the needle hub rests on the base. Further, a pair of bosses is provided to prevent an undesirably large opening angle between the needle hub and the base.

In the area of subcutaneous medication device access (port), where Huber needle assembly is used, an existing safety device offer a margin of protection from accidental needle sticks when removing the needle, or "sharp," from the port. One danger from de-accessing a subcutaneous port is the result of how the port itself is constructed. The port is made up of metal or plastic material with a pierceable area, often made of a silicone compound, through which access is made by a Huber needle to the vascular system for the purpose of infusing medication into the body. The port is implanted within a cavity formed in the patient, such as in the chest area, and sutured to underlying tissue. From time to time, it is desirable to refill the port via the septum and/or provide an external source of fluid, e.g., IV access. One type of device used to refill an implanted port is generally known as a Huber needle.

The Huber needle is specially designed to reduce the possibility of mechanically damaging and/or removing a portion of the pierceable area as it is punctured, and which is referred to as "coring. " This coring limits the number of times a port can be accessed. To combat this damage and extend the useful life of the port, the silicone compound is inserted under pressure into the device. It is this pressure that is the arbiter of the danger to the medical practitioner removing the needle used to cannulate the port.

Conventional Huber needle assemblies are designed for safety of patients. They do, however, present considerable risks to the medical practitioners using them. A conventional Huber needle assembly requires two hands to extract its Huber needle from an implanted port. One hand is used to stabilize the implanted port, while the other hand is used to withdraw the needle. The force required to withdraw the needle from the self-sealing septum of the implanted port can cause the needle to rebound and stick the user. This may result in transfer of a blood-borne pathogen to the user. Further, it may expose the user to hazardous drugs.

Although several alternate Huber needle assemblies are available, a need still exists for a Huber needle assembly with safety features that minimize the risk of exposure to blood-borne pathogens or drugs or accidental needle pricks.

A primary object and advantage of the present invention is to provide a huber needle assembly which is efficient, effective and simple in its construction and use.

It is another object of the present invention to provide a huber needle assembly with safety mechanism.

It is another object of the present invention to provide a huber needle assembly with safety mechanism having automatic control features.

It is another object of the present invention to provide a Huber needle assembly which provides better protection against accidental pricking by the needle tip.

It is another object of the present invention to provide a Huber needle assembly which is inexpensive to manufacture.

It is another object of the present invention to provide a compact design for a huber needle assembly.

In accordance with one of the embodiments of the present disclosure, a huber needle assembly having a safety mechanism comprising a main body. The main body comprises a needle hub and a base, the needle hub having distal end and a proximal end, a huber needle is slidably disposed across the needle hub throgh the needle fitment area, the huber needle comprising a tip, a wing holder at the base having two wings at the opposite end of the wing holder, a conduit through which an axle is placed to connect the base with the needle hub, a connector is slidably arranged across the space provided between the distal end and the proximal end of the needle hub through a lever and the chamber at the base through a crank , the dimension of the space is according to the length of the connector, so that the connector is axially arranged across the space of the needle hub at the ready position of the huber needle, the distal end of the needle hub having a flip. The connector is attached through a lever within the space which connect the needle hub and base. The needle hub having a channel through which huber needle passes and which is connected to the tube. The one end of the tube is connected to the proximal end of the needle hub and other end of the tube is connected to the luer lock, the luer lock having female luer in order to make leak-free connections between two parts. The tube has a clamp to regulate the flow of liquid through the tube.

Accordingly to another embodiment, of the present disclosure relates to a huber needle assembly having a safety mechanism according to another embodiments of the present disclosure. The main body comprises a huber needle assembly with a safety mechanism for guarding the huber needle tip against accidental pricking. The main body comprising a needle hub and a base, the needle hub which contain the huber needle with a needle tip, the needle hub having distal end and a proximal end, the distal end of the needle hub having a flip, a wing holder having two wings at the opposite end of the wing holder, the base is connected to the needle hub through the axle. A connector according to another embodiment of the present disclosure, which connect the needle hub and base. The connector is slidably arranged across the both side the needle hub through the lever which is attached at the chamber of the base. The needle hub having a channel through which needle passes and connected to the tube. The one end of the tube is connected to the proximal end of the needle hub and the other end of the tube is connected to the luer lock having female luer in order to make leak-free connections between two parts. The tube has a clamp to regulate the flow of liquid across supply tube.

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

Embodiments of the presently disclosed invention 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 the medical practitoner using the device and farthest from the patient 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 a patient's vein.

As used herein, the term "in" or "inwardly" or "inner" refers to a location with respect to the device that, during normal use, is the inside of the device. Conversely, as used herein, the term "out" or "outwardly" or "outer" refers to a location with respect to the device that, during normal use, is toward the outside of the device.

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 position" means the huber needle is ready to be inserted into subcutaneously implanted ports for insertion or infusion of fluids.

As used herein "locked position" means the huber needle is safely guarded once the needle is retrieved from the subcutaneous port.

Referring now to <FIG>, it illustrates a huber needle assembly according to one of the embodiments of the present invention. The huber needle assembly having a safety mechanism comprising a main body <NUM> , the main body <NUM> comprising a needle hub <NUM> and a base <NUM>, the needle hub having distal end <NUM> and a proximal end <NUM>, a huber needle <NUM> with a needle tip <NUM>, the huber needle <NUM> is slidably disposed across the needle hub <NUM> through a neddle fitment area <NUM>, a wing holder <NUM> at the base <NUM> having two wings <NUM> at both the sides of the wing holder <NUM> opposing each other, a conduit <NUM> through which an axle <NUM> is placed to connect the base <NUM> with the needle hub <NUM> , a connector <NUM> is slidably arranged across the space <NUM> provided between the distal end <NUM> and the proximal end <NUM> of the needle hub <NUM> through a lever <NUM> and across the chamber <NUM> of the base <NUM> through a crank, the dimension of the space <NUM> is according to the length of the connector <NUM>, so that the connector <NUM> is axially arranged across the space <NUM> of the needle hub <NUM> at the ready position of the huber needle <NUM>, the distal end <NUM> of the needle hub <NUM> having a flip <NUM>.

The connector <NUM> connect the needle hub <NUM> and the base <NUM>. The proximal end of the needle hub <NUM> having a channel <NUM> through which a tube <NUM> is fitted which used for infusion of fluids. The one end of the tube <NUM> is connected to the proximal end <NUM> of the needle hub <NUM> and the other end of the tube <NUM> is connected to a luer lock <NUM>, the luer lock <NUM> having female luer <NUM> in order to make leak-free connections between two parts. The tube <NUM> has a clamp <NUM> to regulate the flow of liquid through the tube <NUM>.

The two wings <NUM> are made up of soft material which attached at the wing holder to provide comfortable contact and hinge connection with needle hub <NUM> and connector <NUM>. The wings <NUM> can be pivoted up to be grasped by in the fingers of a clinician, or pivoted downward to be applied on the skin of the patient. In some implementations, the wings <NUM> have a groove structure or texture formed into their upper and/or lower surfaces, to enable better grasping of the wings <NUM>.

In some embodiments , the channel <NUM> is sized and adapted for a tight fit around the tube <NUM>. In some embodiments , the channel <NUM> can be formed to have a tolerance around the tube <NUM> that provides a predetermined coefficient of friction for relative ease or difficulty in sliding the needle hub <NUM> relative to the tube <NUM>. The luer lock <NUM> and female luer <NUM> have <NUM>% tapper fitting. The tapper fitting of the luer lock and female luer can be vary according the requirement.

Referring to <FIG> a side view of the huber needle assembly in a ready position according to embodiment of <FIG>. It illustrate a position when the huber needle <NUM> is positioned and inserted into the port for fluid extraction or insertion. At the ready position, the huber needle <NUM> is at <NUM>° with respect to the base <NUM> and a sharp distal end that is formed (i.e. bent) and adapted to allow ease of penetration of skin and/or port while minimize coring damage, the connector <NUM> is axially (A) arranged across the space <NUM> of the needle hub <NUM> through the locking shaft <NUM> of the needle hub <NUM> with a knob <NUM>. The locking shaft <NUM> having a first end <NUM> and a second end <NUM>. The locking shaft <NUM> has a locking protrusion <NUM> with a groove <NUM> across the second end <NUM> of the locking shaft <NUM>.

Referring to <FIG> a perspective view of the huber needle assembly in a locked position according to the embodiments of <FIG>. It illustrates the position when the huber needle <NUM> is removed from the port and a subsequent protection of the huber needle <NUM> is made. The huber needle <NUM> passes through a bore <NUM> at the distal end of the needle hub <NUM> across a channel <NUM> at the proximal end of the needle hub <NUM> through the needle fitment area <NUM> , the channel <NUM> is connected to the tube <NUM> used for infusion of fluids. It shows that when the huber needle is extracted from the port the huber needle <NUM> is tilted by <NUM>°-<NUM>° with respect to the needle hub <NUM> and passes through the bore <NUM> to the channel <NUM>, the connector <NUM> will slide from first end <NUM> of the locking shaft <NUM> to the second end <NUM> of the locking shaft <NUM> with the help of lever <NUM> and crank. The knob <NUM> fixed across the lever <NUM>, the knob <NUM> will slide according to the position of the lever <NUM> across the locking shaft <NUM> and stuck or locked across the groove <NUM> once the lever <NUM> will locked across the locking protrusion <NUM>. The axle <NUM> at the proximal end <NUM> of the needle hub <NUM> is used to restrict upward motion of the needle hub <NUM>. Once the knob <NUM> will get locked at the grove <NUM>, the tip <NUM> of the huber needle <NUM> will stuck/ locked between an aperture <NUM> of the wing holder <NUM>.

Referring to <FIG> locking mechanism of the huber needle assembly in a locked position according to the embodiments of <FIG>. It illustrates the locking mechanism <NUM> for the safety function of the huber needle <NUM>, which automatically guard the huber needle while retrieving the huber needle from the port through the connector <NUM>. It shows the position of the lever <NUM> of the connector <NUM> across the locking protrusion of the locking shaft <NUM>. The huber needle <NUM> is locked between the aperture <NUM> of the wing holder <NUM>.

Referring the <FIG> illustrate the views of needle hub <NUM> according to the embodiments of <FIG>. <FIG> shows the perspective view of the needle hub <NUM> having a flip <NUM> which is used to activate/lift the connector <NUM>, the channel <NUM> provide fitment area for the tube <NUM> for infusion of fluids. The locking shaft <NUM> for sliding the connector having locking protrusion <NUM> between the first end <NUM> and second end <NUM> of the locking shaft <NUM> which is used to permanently locked the connector, groove <NUM> across the second end <NUM> of the locking shaft <NUM> which is used to lock the knob <NUM>. <FIG> shows another perspective view of the needle hub <NUM> having a bore <NUM> through which huber needle passes to the channel. <FIG> shows another perspective view of the needle hub <NUM> which shows the needle fitment across the Y-Section of the needle hub and the tube <NUM> for passage of fluid. <FIG>shows the top view of the needle hub <NUM>. The Y-Section shows the horizontal position of the needle hub.

Referring to <FIG> a bottom view of the huber needle assembly according to the embodiments of <FIG>. It shows the bottom view of the main body <NUM> comprises a needle hub <NUM> having a space <NUM> across which connector <NUM> is attached and a bore <NUM> through which huber needle <NUM> is passes to the channel <NUM>. The bottom side of the wings <NUM> at the opposite sides of the wing holder <NUM>. The wing holder works as a shield when safety mechanism activated and the wings <NUM> provide gripping to hold the needle hub <NUM> while insertion of huber needle <NUM> into the port at the subcutaneous area of the skin.

The wings <NUM> are connected with the wing holder at the base that enables the wings <NUM> to be bent, rotated, pivoted, flapped or otherwise moved up or down. For instance, two opposing wings <NUM> can be bent upward to be grasped by the clinician to control the movement, direction, insertion and extraction of the needle attached thereto. In another instance, once the needle is inserted into the skin of the patient, the two wings <NUM> can be bent downward toward the skin surface of the patient, or onto a patch or other retaining mechanism.

Referring to <FIG> illustrate the cross-sectional view of the huber needle assembly according to the embodiments of <FIG>. It illustrate the position of the hubber needle <NUM> at its protected state. The huber needle is passes across the bore <NUM> through the needle fitment area <NUM> to the channel <NUM> for infusion of fluid to the tube <NUM>.

Referring to <FIG> a huber needle assembly according to another embodiments of the present invention. The main body <NUM> comprises a huber needle assembly with a safety mechanism for guarding the huber needle tip against accidental pricking. The main body comprising a needle hub <NUM> and a base <NUM>, a huber needle <NUM> with a needle tip <NUM>, the needle hub <NUM> having distal end <NUM> and a proximal end <NUM>, a needle fitment area <NUM> between the distal end <NUM> and proximal end <NUM> of the needle hub <NUM> through which huber needle <NUM> will pass, the distal end <NUM> of the needle hub <NUM> having a flip <NUM>, a wing holder <NUM> having two wings <NUM> at the both side of the wing holder <NUM> opposing each other, a conduit <NUM> through which an axle <NUM> is placed to connect the base <NUM> with the needle hub <NUM>.

A connector <NUM> according to another embodiment of the present invention, which connect the needle hub <NUM> and base <NUM>. The proximal end of the needle hub <NUM> having a channel <NUM> through which needle passes and connected to the tube <NUM>. The one end of the tube <NUM> is connected to the proximal end <NUM> of the needle hub <NUM> and the other end of the tube <NUM> is connected to a luer lock <NUM> having female luer <NUM> in order to make leak-free connections between two parts. The tube <NUM> has a clamp <NUM> to regulate the flow of liquid across tube <NUM>.

Referring to <FIG> a side view of the huber needle assembly in a ready position according to another embodiment of <FIG>. It illustrate the position when the huber needle <NUM> is positioned and inserted into the port for fluid extraction or insertion. At the ready position, the huber needle <NUM> is at <NUM>° with respect to the base <NUM> and a sharp distal end that is formed (i.e. bent) and adapted to allow ease of penetration of skin and/or port while minimize coring damage, the connector <NUM> is axially (A) arranged across the locking shaft <NUM> of the needle hub <NUM>. The locking shaft <NUM> having first end <NUM> and second end <NUM> with a groove <NUM> across the second end <NUM> of the locking shaft <NUM>. The connector <NUM> have locking protrusion <NUM>.

Referring to <FIG> a perspective view of the huber needle assembly in a locked position according to another embodiment of <FIG>. It illustrates the position when the huber needle <NUM> is removed from the port and a subsequent protection of the huber needle <NUM> is made. The connector <NUM> is slidably arranged across the both side of the needle hub <NUM> through the lever <NUM> which is attached at the chamber <NUM> of the base <NUM>. The huber needle <NUM> passes through a bore <NUM> at the distal end of the needle hub <NUM> across a channel <NUM> at the proximal end of the needle hub <NUM>, the channel is connected to the tube <NUM> used for infusion of fluids. It shows that when the needle is extracted from the port the huber needle is tilted by <NUM>°-<NUM>° with respect to the needle hub <NUM> and passes through the bore <NUM> to the channel <NUM>, the connector <NUM> will slide from first end <NUM> of the locking shaft <NUM> to the second end <NUM> of the locking shaft <NUM> where the locking protrusion <NUM> of the connector <NUM> will be stuck/locked at the groove <NUM> of the locking shaft <NUM>. The axle <NUM> at the proximal end <NUM> of the needle hub <NUM> is used to restrict upward motion of the needle hub <NUM>. Once the locking protrusion <NUM> will get locked at the grove <NUM> and the tip <NUM> of the huber needle <NUM> will stuck/locked between an aperture <NUM> of the wing holder <NUM>.

Referring to <FIG> locking mechanism of the huber needle assembly in a locked position according to another embodiments of <FIG> is illustrated. It illustrates the locking mechanism <NUM> for the safety function of the huber needle <NUM>, which automatically guard the huber needle <NUM> while retrieving the huber needle from the port through the connector <NUM>. It shows the position of the locking protrusion <NUM> of the connector <NUM> across the groove <NUM> of the locking shaft <NUM>. The needle is locked between the aperture <NUM> of the wing holder <NUM>.

Referring the <FIG> illustrate the views of needle hub <NUM> according to another embodiment of <FIG>. <FIG> shows the perspective view of the needle hub <NUM> having a, the channel <NUM> provide fitment area to the tube <NUM> for infusion of fluids. The locking shaft <NUM> having first end <NUM> and second end <NUM>, groove <NUM> across the second end <NUM> of the locking shaft <NUM> which is used to permanently locked the connector <NUM>. <FIG> shows another perspective view of the needle hub <NUM> having a flip <NUM> which is used to activate/lift the connector <NUM>. <FIG> shows another perspective view of the needle hub <NUM> which shows the needle fitment area <NUM> horizontally (Y-Section) across the needle hub <NUM> and the tube <NUM> for passage of fluid. <FIG> shows the top view of the needle hub <NUM>. The Y-Section shows the horizontal position of the needle hub.

Referring to <FIG> a top view of the huber needle assembly in a locked position according to another embodiments of <FIG>. It shows the top view of the main body <NUM> comprises the needle hub <NUM> and the wings <NUM> at the opposite sides of the wing holder <NUM>. The wing holder works as a shield when safety mechanism activated and the wings <NUM> provide gripping to hold the needle hub <NUM> while insertion of huber needle <NUM> in to the port at the subcutaneous area of the skin.

Referring to <FIG> illustrate the cross-sectional view of the huber needle assembly according to another embodiments of <FIG>. It illustrate the position of the hubber needle at its protected state. The huber needle is passes through the bore <NUM> to the channel <NUM> for infusion of fluid to the tube <NUM>.

Referring to <FIG> the perspective view of the huber needle assembly with foam pad according to another embodiment of <FIG>. The top of the base <NUM> is covered with a foam pad <NUM>, which is a non-absorbent foam pad, the foam pad is designed to assist with the placement of the huber needle <NUM> into the port for fluid extraction or insertion the base <NUM> with comfort of the patient and closed cell materials are designed to help reduce the risk of needlestick injuries, bacterial exchange and compression.

The construction and shape of the huber needle assembly having a safety mechanism according to the various embodiments of the present disclosure provides a simple configuration. The simple and compact design of the huber needle assembly having safety mechanism according to the above disclosure is advantageous in a clinical setting because it provides an automatic protection against accidental pricking by the needle tip thereby reducing injury or discomfort to a patient and provides better safety features. In addition, such design greatly reduces manufacturing costs and is efficient, effective and simple in its construction and use.

Although this invention has been disclosed in the context of certain preferred embodiments and examples, it will be understood by those skilled in the art that the present invention extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the invention and obvious modifications and equivalents thereof.

Accordingly, it is not intended that the scope of the foregoing description be limited to the exact description set forth above, but rather that such description be construed as encompassing such features that reside in the present invention, including all the features and embodiments that would be treated as equivalents thereof by those skilled in the relevant art.

Claim 1:
A safety mechanism for a huber needle assembly (<NUM>) comprising:
a huber needle (<NUM>) slidably disposed across a needle hub (<NUM>) with a tip (<NUM>);
a connector (<NUM>) having a lever (<NUM>) at its one end that is slidably arranged across a space (<NUM>) provided between a distal end (<NUM>) and a proximal end (<NUM>) of the needle hub (<NUM>), and having a crank at its other end that is pivotally arranged across a chamber (<NUM>) of a base (<NUM>);
a conduit (<NUM>) through which an axle (<NUM>) is placed to hingedly connect the base (<NUM>) with the proximal end (<NUM>) of the needle hub (<NUM>).