SAFETY INTRODUCER NEEDLE ASSEMBLY

A safety introducer needle assembly having an introducer needle defining an axial direction, the needle having an outer surface and an inner surface defining a lumen which extends along the length of the needle in the axial direction; the outer surface defined by a wall of the needle forming a needle shaft that extend along the axial direction having a distal end and a proximal end, wherein the proximal end connected to a needle hub and the distal end comprising a sharp bevelled tip wherein the needle has a roughened or echogenic region having echogenic features; and a needle tip protector housed in a safety barrel and slidably arranged on the needle shaft from moving beyond the needle tip and wherein the safety barrel is engageably attached to the needle hub.

FIELD OF THE INVENTION

The invention generally relates to safety introducer needle assembly, methods of fabrication and methods of its use. In particularly, the invention relates to a needle having echogenic feature for use with an ultrasound imaging system to provide real-time location of the insertion and guidance at the time the device is implanted in a patient and having enhanced safety features.

More particularly, the present invention relates to a safety introducer needle assembly having a safety mechanism for use in medical procedures, and in particular to safety introducer needle assemblies including a needle having echogenic feature and a safety barrel having a needle tip protector to cover a tip of a needle to prevent accidental needlestick injuries.

BACKGROUND OF THE INVENTION

There are a variety of needles available for different medical and surgical uses. For example, intravenous catheters are utilized in various applications for supplying or withdrawing fluids to or from the body. Medical devices having needles for subcutaneous use are also known in the medical field. For example, biopsy needles are used to capture and remove internal tissues while avoiding invasive surgery. When performing medical procedures, often targeted bodily areas are surrounded by blood vessels or internal organs which can cause difficulties with accurate percutaneous positioning of medical devices.

Ultrasonography has been used to obtain images of medical devices inside a patient's body that would otherwise not be possible through direct visualization, the image quality is often less than optimal. This is, in part, because many medical devices do not inherently possess optimal reflective properties with respect to ultrasound waves.

The introduction of ultrasound imaging in the field of medical technology has greatly influenced the field of percutaneous tissue biopsy in the recent times. The use of tissue imaging devices that utilize ultrasound waves allows the physician to “see” inside the body and visually guide the needle to the tumor mass. The inherent problem in visualizing the needle is that the angle of entry of the needle into the body in relationship to the direction of the generation of ultrasound waves precludes an optimized reflection of the ultrasound waves back to the transceiver, thus making it extremely difficult to see the needle in the ultrasound image and locate the needle tip in the image in relationship to the anatomic structures of the body.

Echogenicity or echogeneity is the ability to bounce an echo, e.g. return the signal in ultrasound examinations. In other words, echogenicity is higher when the surface bouncing the sound echo reflects increased sound waves. Needle tip visualization is fundamental to the safety and efficacy of ultrasound-guided injection. However, it can be extremely challenging to visualize the needle tip especially at steep insertion angles without echogenicity.

To increase image clarity, echogenic enhancements which cause an altered or improved reflective response of ultrasound waves can be applied to a medical device and can cause greater ultrasound image clarity of the device. To remedy this, certain medical devices have been designed to possess enhanced sound wave reflectivity, i.e., echogenicity. This in turn can increase accuracy when positioning the medical device. For example, it is known to apply echogenic enhancements near the tip of a needle so that the tip location is known with greater accuracy. It is also known to roughen, by bead-blasting, the outer surface of the needle to improve its echogenicity. A needle for echogenicity is generally known in the art. Echogenicity provide an acoustic impedance different from the surrounding biological tissue or fluid.

There is a constant need for echogenically-enhanced medical devices which can provide an ultrasound image that is more consistent and having better quality across a range of insertion angles and frequencies and body areas. Such echogenically-enhanced medical devices can improve the physician's confidence in placing a medical device.

The procedures for removing a needle from a patient commonly require a medical practitioner to use one hand to place pressure at the wound site or puncture site where the needle is being withdrawn, while removing the needle device with the other hand. It is also common practice for an attending medical practitioner to give higher priority to care for the wound than is given to disposal of a needle. In the case of typical needle devices without safety shields or guards, such priority either requires the convenience of an available sharps container within reach or another means for safe disposal without leaving the patient's side.

An exposed needle tip creates a danger of accidental needle stick injuries which can leave medical personnel vulnerable to the transmission of various blood-borne pathogens, such as HIV and hepatitis etc. Problems of current safety devices include difficulty of use and high cost due to their complexity and number of parts.

Although several alternate needles having echogenicity are available, a need still exists for a needle with safety features against accidental needle stick injuries. While needle tip protectors have been developed to protect the medical personnel from needle stick injuries, improvements on the cost, ease of use, and effectiveness of these needle tip protectors is a constant need. Therefore, it would be beneficial to have safety mechanism that is easily activated by medical personnel, adequately protects the needle having echogenic feature from accidental needle stick injury, and is economical to manufacture.

SUMMARY AND OBJECTS OF THE INVENTION

A primary object and advantage of the present invention is to provide a safety introducer needle assembly including a needle having echogenic feature and having improved safety features.

It is another object of this invention to provide a safety introducer needle assembly including a safety barrel having a needle tip protector to cover a tip of the needle to prevent accidental needlestick injuries.

It is another object of this invention to provide a safety barrel having a needle tip protector that is simple and easy to use.

It is another object of this invention to provide a needle tip protector that automatically covers the sharp distal tip of the introducre needle upon withdrawal of the introdcure needle.

It is another object of the present invention to provide a needle with enhanced echogenicity and having improved safety features.

It is another object of the present invention to provide an improved needle design to more reliably visualize the design of the needle under ultrasound guided biopsy procedures.

It is another object of the present invention to provide a needle design that allows the visualization of the needle at any angle of entry into the body in relationship to the generation of sound waves by the ultrasound transceiver.

It is another object of the present invention to provide a needle design that allows visualization that does not impede the smooth passage of the needle through the surrounding tissue.

It is yet object of the present invention to provide an improved needle design that allows visualization of the distal tip of the needle, thus allowing the physician to visualize the extreme distal end of the needle set.

It is yet object of the present invention to provide a needle with engagement means for example, a change in profile proximal to needle tip to enhance safety feature thereof.

It is yet another object of the present invention to provide a needle with enhanced sound wave reflectivity for echogenicity.

It is another object of the present invention to provide a compact design for a needle having safety mechanism.

In accordance with one of the embodiments of the present invention, there is provided a safety introducer needle assembly having an introducer needle defining an axial direction. The needle having an outer surface and an inner surface defining a lumen which extends along the length of the needle in the axial direction. The outer surface is defined by a wall of the needle forming a needle shaft that extend along the axial direction having a distal end and a proximal end, wherein the proximal end is connected to a needle hub and the distal end comprises a sharp bevelled tip wherein the needle alternatively or additionally have a roughened or echogenic region that may include one or more projections, depresssions, voids, grooves, ribs and/or protuberances of the types described further below. Proximal from the needle tip the needle shaft is provided with an engagement means for preventing a needle tip protector housed in a safety barrel and slidably arranged on the needle shaft from moving beyond the needle tip. The safety barrel is engageably attached to the needle hub.

Some embodiments of the present invention further comprise at least one safety barrel engaging element configured to restrict the rotation of the safety barrel and in turn of the needle tip protector with respect to the needle hub. The needle hub may comprise a corresponding safety barrel anti-rotation element configured to engage the safety barrel engaging element. The safety barrel can 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 can comprise at least one slit or recess, which passes through the thickness of the distal surface. The safety barrel can 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 can support the holding of the safety barrel with the needle hub. Thus, the safety barrel can be snap fitted with the needle hub. The snap-fit may be formed by a protrusion and a corresponding recess which can be provided in both needle hub and safety barrel alternatively. Other ways and means for a secure engagement are also encompassed.

Some embodiments of the present invention further comprise a curved profile of the safety barrel. The curved profile may simplify assembly of the safety barrel with the needle hub.

As well known in the art, the needle may also have a needle feature close to its needle tip, which interacts with a proportional base of the needle tip protector or needle guard, e.g. an enlargement, a curving or a bulge or crimp any other change in profile. Thereby, it can be prevented that the needle is retracted out of the needle tip protector, which is known in the art.

The invention also relates to a medical device for example, a safety introducer needle assembly including a needle tip protector housed in a safety barrel and further including a needle with echogenic feature having a needle shaft, a needle tip and a needle hub. The needle tip protector being housed in the safety barrel is slidably arranged on the needle, wherein the needle tip protector is movably retained in the inner space of the safety barrel when the needle extends there through, and wherein the needle tip protector captures the needle tip once it is received in the needle tip protector upon withdrawal of the needle in protected position. The inner space of the safety barrel defines a chamber ensuring that a first and second arms of the needle tip protector do not engage or interact with an inner surface of the chamber prior and during venipuncture of a patient. The needle tip protector of this kind is generally known. The needle tip protector serves to prevent a person handling the intravenous catheter apparatus from accidentally coming into contact with the needle tip post removal of the needle from a patient's vein. Thus, the safety introducer needle assembly helps to avoid unwanted transmission of blood borne diseases.

The improved needle tip design according to the present invention can be used on the needles of either manual or automated biopsy needle instruments used for the performance of tissue extraction or fluid aspiration visualized under ultrasound guidance.

DESCRIPTION OF THE INVENTION

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 “echogenic” describes the characteristic ability of a surface or device to direct a relatively favorable quality and quantity of an ultrasound signal back to a transducer for imaging purposes in comparison to a surface or device (or portion thereof) which is less echogenic, non-echogenic, or echolucent. In other words, a device or surface with increased echogenicity (or greater echogenic response) provides enhanced ultrasound imaging capabilities compared to a device or surface which is less echogenic or more echolucent. As used herein, “echogenic” and “echogenicity” typically refers to characteristics of device for example a needle having a sharp tip when device is positioned within a body conduit or other such environment where fluids and/or body tissues surround device.

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.

The term “patient” should be understood to refer to a human or other animal and the term “medical personnel” should be understood to refer to a doctor, nurse, or clinican or medical practitioner or other care provider and may include support personnel.

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.

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 safety introducer needle assembly is ready for use, such as to perform a venipuncture or intravenous access. Sometimes the ready position first requires removing a protective cap from the catheter assembly or needle assembly. The protective cap can be included for packaging.

As used herein “protected position” means the safety introducer needle assembly in particular the needle hub having a needle is ready for disposal in that the needle tip is safely guarded by a needle tip protector.

Referring now toFIGS. 1A & 1Ban overall view of a safety introducer needle assembly10according to the present invention is shown comprising a protective needle cover38which is attached to a needle hub22. The needle hub22can be provided with or without wings. The protective cover38can be formed of a plastic or metal or other suitable material and has inner space. In various embodiments, the outer periphery and/or inner periphery of the protective cover38body at its proximal end18can include one or more luer threads or the like in any number of thread configurations available to provide and interlock between the protective cover38and needle hub22.

The inner space of the protective cover38receives the needle12and a safety barrel42housing a needle tip protector40which is movably arranged on the needle shaft14. The inner space of the protective cover38may be parallel to the axial direction and defined between a distal end section37and a proximal end section39of the protective cover38. The dimension of the inner space at the proximal end section is bigger in size in comparison to dimension of the inner space at the proximal end section of the protective cover38. The advantage of change in dimension of inner space lies in the fact that inner space at the proximal end section of the protective cover38is dimensioned very precisely in order to ensure an inner space with a well-controlled and large enough diameter such that no part of the safety barrel42when housed in the inner space of the protective cover38enclose inner surface of the protective cover38.

It should be understood that device10could be any of a variety of types of safety introducer needle assembly which are used for percutaneous, subcutaneous or other internal applications involving ultrasound imaging and therapeutic techniques (e.g. biopsy needles, intravascular devices, laparoscopic tools, etc.).

FIGS. 2A and 2Billustrate a safety introducer needle assembly10without the needle cover38and show a needle12having echogenic feature defining an axial direction A. A needle tip protector40as shown inFIGS. 4A to 4Cis movably arranged on the needle shaft14and retained in a safety barrel42. The safety barrel42is engageably attached to the needle hub22prior to use of the device10in ready position as shown inFIGS. 2A & 4A.

Referring now toFIGS. 2C & 2Dwhich show enlarged views of the locking arrangement between the safety barrel42and the needle hub22comprising at least one safety barrel engaging element configured to restrict the rotation of the safety barrel42and in turn of the needle tip protector40with respect to the needle hub22. The needle hub22is provided with a corresponding safety barrel anti-rotation element configured to engage the safety barrel engaging element. As shown inFIGS. 2C& 2D, the safety barrel42is snap fitted with the needle hub22. The snap fit is formed by the engaging element comprising the needle hub22having a peripheral wall56projecting from a distal surface54of the needle hub22. The peripheral wall56of the needle hub22comprises at least one slit or recess58, which passes through the thickness of the distal surface54. The safety barrel42is provided with at least one lateral protrusion60from edge of a proximal surface48configured to be received by the slit or recess58within the needle hub22forming a snap fit arrangement. The lateral protrusion60supports the holding of the safety barrel42with the needle hub22. Thus, the safety barrel42is be snap fitted with the needle hub22. The snap-fit can also be formed by a protrusion and a corresponding recess which can be provided in both needle hub22and safety barrel42alternatively.

Alternative arrangements by way of replacing the change of dimensions outside the safety barrel42at the proximal end thereof and on the distal surface54or upper part of the needle hub22can also be employed. For example, the upper part of the needle hub22can be made with a fitment and be snap-fitted with the safety barrel42. 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 can be a continuous ring or a spaced apart formation. Other ways and means for a secure engagement are also encompassed.

Referring now toFIGS. 4A to 4C, the safety barrel42is provided with a proximal wall48formed by a barrel cap62and distal wall50wherein both the proximal wall48and distal wall50has a bore52to receive the needle12. The inner diameter of the bore52has a close fit ratio with the outer diameter of the needle12. The thickness of the proximal wall48is greater than the thickness of the distal wall50. The safety barrel42is provided with inner space44defining a housing or chamber to movably receive the needle tip protector40as shown inFIGS. 4A and 4C. The needle tip protector40is received within the inner space44through a proximal end18of the needle12which is sealed with a barrel cap62forming the proximal wall48. The barrel cap62is glued to the safety barrel42body using one or more adhesives in a fluid tight manner. The safety barrel42has a substantially cylindrical shape, which is structurally beneficial to the provision of rotation capabilities. The safety barrel42can have other geometrical shapes with inner space44to house a needle tip proctor40. The outer surface of the safety barrel42is provided with finger grips46for ease of handling, activation and easy movement and better grip. The safety barrel42is made of plastic material or glass having transparent qualities for visibility and designed with ergonomic feel for better control and ease of handling.

As can be seen inFIG. 4A, the proximal end18of needle12may comprise at least one opening76providing communication between a lumen of the needle12and a flash back chamber78provided in the needle hub22which is transparent to improve visibility and for instant flash back confirmation. The needle hub22is made of transparent plastic material to provide a view of the interior and thus of the blood therein. In the event of first venipuncture blood entering the lumen of the needle12can exit the needle12through the opening76and thus become visible for the person handling. The opening76is preferably large enough in order to provide a blood flashback function such that the practitioner can recognize that he has placed the needle12correctly within a patient's vein. In case of a correct positioning of the needle12, blood pours out of the opening76within the flash back chamber78and visible through the transparent needle hub22and is visible to the practitioner. Alternatively, an opening76positioned close to the needle tip20can also be provided so that the blood does not have to travel the length of the needle12to enter the needle hub22in order to become visible. In such a case, blood entering the lumen of the needle12upon venipuncture partly exits the needle12near the needle tip20through the opening76, thereby becoming particularly quickly and, thus, allowing for particularly fast venipuncture confirmation. The opening76may have a miniscule size which serves the purpose of early flashback detection and which does not obstruct the arms of the needle tip protector40.

Referring now toFIG. 3, the needle12has an outer surface24and an inner surface26defining a lumen28which extends along the length of the needle12in the axial direction A. The outer surface24is defined by a wall of the needle12forming a needle shaft14that extend along the axial direction A having a distal end16and a proximal end18, the distal end16comprises a sharp bevelled tip20. Needle12may be made of a metal, a metal alloy, or any other material readily observable by ultrasound. In addition, needle12alternatively or additionally have a roughened or echogenic region34that may include one or more projections, depresssions, voids, grooves, ribs and/or protuberances of the types described further below. Needle12can be used for providing a puncture site in blood vessels for the introduction of vascular access devices.

The proximal end18of the needle12is attached to a needle hub22which acts as a control end. The control end of device10may extend outside of the patient during use. Alternatively, the control end may attach to another piece that extends outside the patient. The control end generally ends in a handle30having one or more finger grips46or other operating portion for maneuvering device10. Handle30can be any of a variety of forms or structures suitable for use in conjunction with needles or medical devices used in percutaneous applications. Handle30is generally constructed to be manipulatable by hand in some embodiments and has a hollow axis in communication with lumen which can receive a stylet or other cylindrical objects or guide wires. In various embodiments, the outer periphery and/or inner periphery of the needle hub22body at its proximal end18can include one or more luer threads or the like in any number of thread configurations available to provide and interlock between mating devices. The luer threads allow another medical device having a male luer lock to be connected to and interlocked with the needle hub22. In this manner, a separate access device can be coupled to the safety introducer needle assembly10through the needle hub22port to establish fluid communication there through. Alternatively, the needle hub22body can also have no luer threads to accommodate luer slip and luer lock connections.

Proximal from the needle tip20the needle shaft14is provided with an engagement means32for preventing a needle tip protector40which is housed in a safety barrel42and slidably arranged on the needle shaft14from moving beyond the needle tip20. The engagement means32may comprise any form of irregularity of the needle shaft14, for example, an enlargement of the outer profile of the needle shaft14at least in one direction transverse to the axial direction A.

In the illustrated embodiment, the engagement means32comprises a change in profile in the form of a crimped portion of the needle shaft14. The enlargement is made by a crimping of the needle shaft14. The change in profile32has an outer profile one dimension of which is larger than a maximum dimension of the profile of the through-bore of a stopping element provided in a needle tip protector40. However, other ways of forming the enlargement are possible, such as applying additional material to the needle shaft14, e.g. by soldering, welding or gluing etc. In alternative embodiments, the change in profile32can be provided anywhere between the distal end16and the proximal end18of the needle shaft14.

The inner profile of the needle can either be reduced in the region of the enlargement32, for example, if the enlargement32is formed by crimping, or it can be substantially constant throughout the length of the needle12, for example, if the enlargement32is formed by applying additional material to the needle shaft.

Referring further toFIG. 3, it illustrates distal end16of the needle12encircled inFIG. 2A. The needle12has one or more echogenic regions (for example, echogenic region34). The echogenic region34is provided with one or more echogenic features36that enhance the echogenicity of device10. The echogenic region34is at least a portion of the needle12, and in particular embodiments is at least a portion of outer surface24of the needle12. Echogenic feature36may include projections, depresssions, voids, grooves, ribs and/or protuberances or a combination thereof forming rough surface in the outer surface24, which can have any of several possible geometric configurations.

In the embodiment shown inFIGS. 2A and 3the combination of projection and grooves forming the echogenic feature36have a spiral form having helical grooves. The echogenic feature36also includes providing features in the form of a concave surface which has multiple angles and corners which are of assistance in reflecting ultrasound images. The helical groove can have a constant pitch or helical angle, multiple pitch angles (increasing or decreasing pitch angle) and/or include multiple grooves. In some embodiments, echogenic features36can be arranged to span longitudinally along outer surface24and along the longitudinal axis. In other embodiments, the depth of echogenic features36varies over the echogenic range/region34. This variance can extend even to echogenic features36having the same helical groove or projection. Similarly, the relative angles between the walls (or surfaces) of echogenic features36can vary along the longitudinal axis.

In this unique configuration, the smaller radius captures the higher frequency of ultrasound and the larger radius captures the lowest or lower frequency of the ultrasound. Some prior art devices include ridges or bumps that extend above the needle or device surface which increase echogenicity but also increase drag force which is painful for the patient and can cause tenting or damage of the vessels or other internal body parts upon insertion or removal of the device from a patient. The echogenic feature36of the invention has a configuration which ensures that while retracting it does not increase the drag force and does not cause pain to the patient. Beneficially it has been found that these configurations increase echogenicity of the device10and improve image quality with ultrasound.

The echogenic features36can occupy a portion or all of tip20, a region adjacent to tip20, or other parts of device10or needle12. In the embodiment ofFIGS. 2A and 3, an echogenic region34is positioned near tip20so that not only can device10be located during ultrasound procedures but also tip20can be more accurately positioned during ultrasound procedures. In some other embodiments, one or more echogenic regions34can also be positioned further from tip20, and can be spaced a known distance apart to provide information to a user during ultrasound procedures, such as the distance of insertion of a needle12or the proximity of the tip20to certain body tissues.

During use, device10having the echognic feature36is inserted into a body conduit either through puncture or through an existing body conduit. An ultrasound imaging system including a console is used to image device10during insertion and while maneuvering device10to a desired location within the body. The ultrasound imaging system includes a transducer which is applied to the external surface of the body. The transducer transmits ultrasound signals generally towards device10. Device10scatters and/or reflects a certain amount of the ultrasound signal back to the transducer. The transducer receives the returned ultrasound signal and transmits appropriate information to the console. The console displays an image which shows device10surrounded by body tissues and fluids. It is preferable for device10to appear with greater clarity and brightness than the surrounding body tissues and fluids. This is achieved by providing device10with enhanced echogenic properties. Echogenic feature36including a combination of projections and grooves provide device10with enhanced echogenic properties. Use of such echogenic features enhances echogenicity as compared to a smooth surface for a similar object. Device10having echogenic features36is capable of providing enhanced ultrasound visualization throughout a wide range of ultrasound frequencies and relative angles between device10and the transducer.

The construction and shape of the needle having echogenic feature36according to the various embodiments of the present disclosure provides a simple configuration. The simple and compact design of the needle for echogenicity according to the above disclosure is advantageous in a clinical setting because it provides an enhanced sound wave reflectivity for the safety and efficacy of ultrasound-guided medical devices and 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.

To explain further referring toFIGS. 4A to 4C, the use of echogenic needle with the needle tip protector40housed in a safety barrel42, the safety introducer needle assembly10for example, the safety introducer needle assembly of the invention comprises a needle12defining an axial direction and having a needle shaft14and a needle tip20at a distal end16of the needle shaft14. The needle shaft14comprises an engagement means32in the form of for example, a change in profile of the needle shaft14which is adapted to engage with a needle tip protector40slidably arranged on the needle shaft14in order to prevent the needle tip protector40from sliding off the needle tip20.

The needle12having echogenic feature36post use is protected by a needle tip protector40housed in a safety barrel42, wherein the needle tip protector40includes a base portion70made of a first material and having a needle passage which extends in an axial direction A from a proximal side of the base portion through the base portion70to a distal side of the base portion70, such that a needle12having a principal outer profile can be movably arranged in the needle passage. The needle tip protector40further includes first64and second arms66extending substantially in the axial direction from the distal side of the base portion, with the first arm64having a distal region and a proximal region. A distal wall68is transversely arranged in the distal region of the first arm64. The distal wall68is having a length and width much bigger than the outer diameter of the needle12such that it completely covers and blocks the needle tip20in protected position.

The needle tip protector40also includes a stopping element which is slidably arranged on the needle shaft and movable relative to the base portion. The stopping element is adapted to engage with an enlargement of the needle shaft14on 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 tip20, i.e. from being separated from the needle12.

According to an embodiment, the stopping element completely surrounds the needle12. The length of the stopping element, i.e. its dimension seen in the axial direction, may vary. As such, the stopping element can, for example, be a disk, a ring, or a tube. According to an alternative embodiment, 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 is of non-circular form, for example, of oval or polygonal shape.

According to an embodiment, the stopping element is arranged in the base portion. For example, the stopping element can be arranged in a cavity or cut out provided in the base portion. Alternatively, the stopping element can be arranged anywhere between the first and second arms.

According to a further embodiment, the stopping element is made of a second material different from the first material. Preferably, the second material is 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.

Prior to the use of the device10, the needle tip protector40is arranged in the safety barrel42which is snap fitted with the needle hub22. In this situation, the needle12extends completely through the needle tip protector40, thereby deflecting the first arm of the needle tip protector40outwards, i.e. at an angle to the axial direction A, such that the distal wall of the first arm is supported on the needle shaft14. Following the insertion of the needle12into a patient and subsequently when the needle12is withdrawn from the patient and the needle shaft14moves through the needle tip protector40while the needle tip protector40is retained in the safety barrel42. Once the needle tip passes the transverse distal wall68of the needle tip protector40, i.e. such that the needle shaft14no longer supports the distal wall68, a restoring force ensures that the first arm64of the needle tip protector40is moved back into alignment with the axial direction of the needle tip protector40, so that the needle tip is blocked by the distal wall68of the needle tip protector40, i.e. the needle tip20is prevented from axially projecting out of the safety barrel42.

To explain further and referring now toFIG. 4D, the first arm64of the needle tip protector40which is housed in the safety barrel42can be longer than the second arm66and has a massive distal wall68having an undercut for catching the needle tip20. The distal wall68is arranged at a distal end16of the first arm64and extends in a direction transverse to an axial direction A of the needle12such that the distal wall68completely blocks the needle12. The distal wall68ensures that the needle tip16is prevented from axially projecting out or sideways projecting out of the needle tip protector40. The distal wall68has a bigger dimension than the distal surface of the second arm66and much bigger dimension than the outer diameter of the needle12such that the distal wall68completely covers and blocks the needle tip20once confined and entrapped within the needle tip protector40. The first and second arms64,66of the needle tip protector40extend generally in the axial direction A from a distal side of the base portion70, i.e. generally parallel to the needle shaft14.

In the ready position, the first arm64deflects outward of the needle tip protector40such that the distal wall68of the first arm64is supported on the needle shaft14. Further, in this ready position, the first and second arms64,66do not engage or interact with an inner wall/surface of the safety barrel42prior and during venipuncture of a patient. This non-contact of the first and second arms64,66with the inner surface of the safety barrel42significantly decreases the withdrawal force required and friction caused when a needle12is withdrawn through a patient being protected by a needle tip protector40after use. The safety barrel42of the invention is clear, colorless and transparent. To this end, the safety barrel42is made of optically clear material such as a plastic material or a rigid plastic material having transparent qualities such as glass or the like for visibility and designed with ergonomic feel for better control and ease of handling. The embodiments of the invention include a safety barrel42, which may be made of optically clear material rigid plastic material and/or other chemicals or in the alternate the safety barrel42can be made colored being non-transparent as well.

Once the needle tip is blocked by the distal wall68, the enlargement32of the needle shaft14engages with the stopping element arranged in the base portion70, to prevent the needle tip protector40from being removed from the needle shaft14. The fact that the stopping element is made from a second material which is harder and less easily distorted than the first material of the base portion, has the effect that the needle tip protector40is secured more effectively on the needle shaft and can be retained in the safety barrel42even if excessive external force is applied when pulling on the needle, as the enlargement32is prevented from being pulled through the base portion70of the needle tip protector40due to the stopping element. Hence, it is less likely that the needle tip protector40is removed from the needle tip20accidentally and, as a result, the needle tip protector40being housed in the safety barrel42provides a better protection against accidental pricking and thus increased safety for the person handling the device10.

In a further embodiment of the needle tip protector40, a tension element72surrounds the first64and second66arms of the needle tip protector40. In the deflected state of the first arm64, the tension element72is expanded against a restoring force of the tension element72. Once the needle shaft14no longer supports the distal wall68, the tension element aids the repositioning of the first arm back into axial alignment with the axial direction. This repositioning is necessary so that the distal wall68can block the needle tip20from axially sliding out of the needle tip protector40and out of the safety barrel42. In addition, the tension element helps to enclose a space between the first and second arms64,66. In other words, the tension element72adds to the protective effect of the needle tip protector40.

The device10is particularly inexpensive to manufacture if the base portion70, the first and second arms64,66of the needle tip protector40are integrally made from a first material.

The first material may, for example, be a plastic material. Thus, the base portion70, the first and second arms64,66could be manufactured by injection molding.

Alternatively, the base portion70, and one of the first and second arms64,66can be integrally made from a first material, e.g. a plastic material, and the other one of the first and second arms64,66can be made from a second material different from said first material. For example, said other one of the first and second arms64,66can include a strip of material having spring-like properties, e.g. a strip of sheet metal, providing the above-mentioned inherent elasticity.

The restoring force is created by at least one of an elastic property of the first arm64and an additional tension element72. The tension element72, for example, a rubber band or the like, surrounds the first and second arms64,66. The tension element72at least partly surrounding the arms64,66by a linear biasing action. Alternatively or additionally, the first64and second66arms can be made of a resilient material having elastic properties.

The construction and shape of the improved device10according to the various embodiments of the present disclosure provides a simple configuration. The simple and compact design of the device10according to the above disclosure is advantageous in a clinical setting because it smoothens the whole process 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. Thus, from the foregoing description, it will be apparent to one of ordinary skill in the art that many changes and modifications can be made thereto without departing from the spirit or scope of the invention as set forth in the claims.

As can be appreciated, the echogenic needle described above is not limited to use in needle aspiration devices, but rather, may be used in other devices that use hollow needles, such as injection needle devices, or in any other device in which visibility to ultrasound may be desirable.

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.

The scope of the present invention herein disclosed is not limited by the particular disclosed embodiments described above but determined only by a fair reading of the complete specification to be filed on this application.

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