Intravenous cannula devices configured to prevent blood backflow and needle prick injuries include a catheter assembly and a needle guard assembly. The catheter assembly includes a hub having a coaxial recess and a valve member positioned therein. The valve member is cylindrical and includes a distal surface having slits collectively defining prongs configured to open and close upon passage of a needle therethrough. Cannula devices configured to prevent needle stick injuries include a safety release component at a distal end of the needle guard assembly. The safety release component includes moveable locking elements configured to fit within an annular groove defined by a proximal portion of the hub upon movement of a needle through the safety release component. Proximal retraction of the needle through the safety release component causes the moveable locking elements to be displaced from the annular groove, thereby decoupling the catheter assembly from the needle guard assembly.

This application claims priority to Indian patent application Ser. No. 20/221,1002361, filed Jan. 14, 2022, entitled “INTRAVENOUS CANNULA,” which is incorporated by reference herein, in the entirety and for all purposes.

TECHNICAL FIELD

The present disclosure relates to medical devices. Implementations include intravenous cannulas configured to prevent needle stick injuries. Implementations also include intravenous cannulas configured to prevent unintentional backflow of blood. Implementations also include intravenous cannulas equipped with improved catheter coupling and release mechanisms configured to facilitate reliable, safe disengagement of a catheter assembly from a needle guard assembly after placement of a distal end of the catheter assembly within a targeted blood vessel.

BACKGROUND

Intravenous cannulas are used to inject and/or withdraw fluids, such as medication, nutrients, or blood, directly into or out of a blood vessel of a patient. Intravenous cannulas typically include a catheter assembly and a needle insertion or protection assembly. A distal portion of a catheter tube included within the catheter assembly can be introduced into a blood vessel using a needle, after which the cannula may be secured to a patient's skin, for example, with an adhesive, which could be tape. The catheter tube included within such devices generally defines a lumen sized to accommodate insertion and retraction of a disposable hollow-bore needle therethrough. For this reason, the devices are occasionally referred to as over-the-needle cannulas.

When a distal portion of a catheter is inserted into a patient's vasculature, the disposable needle passing through the catheter is extended distally to puncture the patient's vein or artery, thereby providing an access point for the cannula to deliver or withdraw the desired fluid(s). The needle is then withdrawn, leaving the catheter assembly in place as a hub, which can be used, for example, for connections to various external hook-ups, e.g., fluid bottles. The catheter hub can also be capped for later use.

Despite their widespread and long-time use, preexisting intravenous cannulas remain problematic on multiple fronts. For example, cannulas often lack the safety features necessary to prevent catheter needles from injuring medical professionals before or after the distal tip of the needle is inserted into a patient's vasculature. Because of the high prevalence of communicable diseases among hospitalized patients in need of catheter-based treatments, the consequences of inadvertent needle pricks can be severe.

Cannulas have been designed to solve this problem by enclosing a portion of the needle within a needle guard housing moveable relative to an elongated needle tube, which may be sized to accommodate the full length of the needle before and after its deployment within a patient's vasculature. The elongated needle tube may constitute a component of a needle insertion assembly, which can be temporarily coupled to a catheter assembly, such that, after a distal portion of the catheter has been placed in a blood vessel, the needle can be withdrawn into the elongated needle tube and the needle insertion assembly disengaged from the catheter assembly. Devices configured in this manner are vulnerable to untimely separation of the catheter assembly from the needle insertion assembly, however, as they often rely entirely on sufficient but not excessive friction for coupling the two components.

Another deficiency associated with the use of preexisting over-the-needle cannulas is that, upon withdrawal of the associated needles, an open channel within the cannula often remains, through which blood can drain and spill from the patient. Aside from excessive blood loss, such backflow and spillage further increases the risk of infection for medical professionals. Blood spillage resulting from uncontrolled backflow creates unhygienic conditions, at least, for both the patient and medical personnel.

Preexisting approaches to minimizing blood spillage fail to minimize these risks and/or are unduly cumbersome to implement. For example, medical personnel may manually apply pressure near the needle insertion site before withdrawal of the needle to reduce the flow of blood, but this method requires skillful implementation of either a difficult two-hand technique executed by a single operator or the involvement of two operators. Both approaches may ultimately fail to prevent the undesirable flow of blood back through the catheter. Closed system intravenous cannulas are occasionally used to stop this unwanted backflow by positioning a dead stopper in the path of the blood flow and an angled side port to allow air escape for flashback visualization and fluid infusion; however, these devices are bulky, complicated to use, and more expensive than most standard products.

Indian patent application number 3031/DEL/2014 (hereinafter referred to as the '3031 patent application) provides another example of a preexisting, but imperfect, catheter device. One problem associated with the device disclosed therein is that, when the needle is retracted from the needle cover, the needle cover does not disengage from the catheter hub, meaning more force is required to disengage the needle cover from the catheter hub. Still further, the needle disclosed in the '3031 patent application does not engage the needle cover with the catheter hub, which impedes the overall functionality of the catheter. This defect forces operators to manipulate the catheter device to extract the needle cover from the hub, which in turn may damage the targeted blood vessel and cause pain.

Other preexisting products and methods utilize a mandrel or obturator to physically block unwanted blood flow, but again, these approaches require enhanced skill and training, and the required devices are typically expensive and complex in structure.

The present disclosure is directed to improved cannulas designed to overcome the aforementioned problems in addition to providing other technical advantages.

SUMMARY OF THE DISCLOSURE

One object of present disclosure is to provide an intravenous cannula device configured to prevent reverse flow of blood.

Another object of present disclosure is to provide an intravenous cannula device with a novel one-way valve design configured to prevent the reverse flow of blood.

Another object of present disclosure is to provide a mechanism for preventing reverse flow of blood that may be applied to a variety of catheter devices.

Another object of the present disclosure is to prevent needle prick injuries that may be sustained by a medical professional before or after puncturing a vein or artery of a patient.

Embodiments of the intravenous cannula devices described herein can include a catheter assembly configured to couple with a needle guard assembly, where both components are configured to accommodate the passage of a needle therethrough. Embodiments of the catheter assembly can include a catheter hub having a proximal end and a distal end, a coaxial recess with an annular stopper disposed at or near the proximal end of the catheter hub, and an undercut portion disposed at or near the distal end of the catheter hub. “Coaxial” refers to a tube in a tube, with their axes running the same direction; the axes in a coaxial arrangement may be, but need not be, coincident.

Embodiments can further include a valve member configured to be disposed inside the coaxial recess of the catheter hub. The valve member can define a cylindrical portion and a flat or curved portion disposed at one end of the cylindrical portion, and a coaxial recess extending from the cylindrical portion to the curved or flat portion. The flat or curved portion can include one or more slits defining a plurality of prongs through which a needle can pass to facilitate the puncturing of a blood vessel of a patient.

Embodiments of cannula devices can include a flashback chamber configured to receive proximally flowing blood indicative of successfully puncturing a targeted blood vessel by the needle extending distally from the cannula. Cannula devices disclosed herein can also include an actuator member having an axial bore. The actuator member can be configured to be disposed within the coaxial recess of the valve member, where it can open the plurality of prongs of the valve member to form a passage for a fluid flow from the proximal end of the catheter hub to the distal end of the catheter hub when a luer lock member is removably connected at the proximal end of the catheter hub abutting the actuator member.

Embodiments can also include a valve closure member having a first surface at a proximal end, a second surface at a distal end, and a through-hole extending between the proximal end and the distal end. The valve closure member can be disposed within the catheter hub such that the first surface of the valve closure member abuts the undercut portion of the catheter hub and the second surface of the valve closure member abuts the curved or flat portion of the valve member. The valve closure member can be configured to close the plurality of prongs of the valve member, thereby closing the passage for fluid flow and preventing blood flow from the punctured blood vessel of the patient from the distal end of the catheter hub to the proximal end of the catheter hub when the luer lock member abutting the actuator member is removed.

In some embodiments, the valve closure member can have a hardness ranging from about 50 Shore to about 80 Shore, and the valve member can have a hardness ranging from about 20 Shore to about 45 Shore. The disparity in hardness values between the valve closure member and valve member can facilitate closing of the valve member by the valve closure member when a needle is not present within the members.

In some embodiments, the shape of the first surface of the valve closure member can be curved, concave, or frustoconical. In some embodiments, the first surface of the valve closure member can have a flat or substantially flat shape. The shape of the first surface of the valve closure member may be complementary to the distal surface of the valve member. Any suitable shape may be used.

In some embodiments, the surface of the valve member defining the slit(s) can be convex or frustoconical. In some embodiments, the surface of the valve member defining the slit(s) can be flat or substantially flat. Any suitable shape may be used.

In some embodiments, the valve member can be configured to be held in place within the coaxial recess of the catheter hub when a first end of the valve member abuts an annular stopper within the catheter hub.

In some embodiments, the valve member can be made of a flexible material, non-limiting examples of which can include silicone, rubber, polymers, and/or Nitinol or other materials. Due at least in part to its flexible composition, the valve member can self-close after retraction of a needle proximally through the valve member.

In some embodiments, the slits defined by the valve member can form a Y-shape, an inverted Y-shape, an X-shape, a + shape, any other shape or orientation, or a combination thereof.

In some embodiments, the cylindrical portion of the valve member can have a protrusion at an inner surface thereof. In some embodiments, the actuator member can have a circular recess at an outer surface thereof. According to such embodiments, the protrusion of the valve member can be configured to engage with the circular recess of the actuator member, thereby forming an assembly comprised of the valve member and the actuator member inside the catheter hub.

In some embodiments, the actuator member can include a first end having a radially extending flange, a second end having a convex surface, and an axial bore extending between the first end and the second end. In some embodiments, the actuator member can include a first end having a radially extending flange, a second end having a flat or substantially flat surface, and an axial bore extending between the first end and the second end.

In some embodiments, the valve closure member can be harder than the plurality of prongs of the valve member such that when the luer lock member is disengaged from the catheter hub, the valve closure member pushes the plurality of prongs and the actuator member in a direction away from the distal end of the catheter hub, thereby preventing blood flow from the punctured blood vessel of the patient from the distal end of the catheter hub to the proximal end of the catheter hub.

In some embodiments, the actuator member can be made of a rigid material, including a rigid plastic or metal.

In some embodiments, the cannula device can include a flashback chamber having a porous filter and a cover to allow air to escape and blood to flow inside the flashback chamber.

In some embodiments, the device can include a needle prick safety device or component.

In some embodiments, the needle guard assembly can include an elongated tubular member and a needle hub comprising a needle holder disposed inside the elongated tubular member. A distal end of the needle holder can be connected to the needle configured to puncture a targeted blood vessel within a patient. Embodiments can also include a safety release component fixed or coupled to a distal end of the elongated tubular member. The safety release component can be configured to releasably couple with the catheter hub, thereby coupling the catheter assembly with the needle guard assembly. The safety release component can include one or more locking elements at or near its distal end, which can be configured to project and/or move radially outwardly when a needle is inserted within the safety release component. Outward projection and/or movement of the locking elements may cause them to fit within, and thus engage with, an annular groove defined by a proximal portion of the catheter hub, thereby forming a locking engagement and/or a tight fit relationship between needle guard assembly and the catheter assembly when the needle is passed through the safety release component to puncture a patient's blood vessel. When the needle is retracted through the catheter assembly and the safety release component after puncturing the patient's blood vessel, the locking elements retract, and/or can be displaced, from the annular groove of the catheter hub, thereby disengaging the safety release component and catheter hub. This disengagement allows separation of the catheter assembly from the needle guard assembly, but only when the needle is enclosed within the safety release component and needle guard assembly. In this manner, embodiments of the cannula devices disclosed herein can shield the distal tip of the needle upon its withdrawal from a patient to prevent inadvertent needle stick injuries.

In some embodiments, the safety release component can define a groove on an outer surface to accommodate the one or more locking elements.

In some embodiments, the one or more locking elements can be solid and spherical. The locking element(s) can also be made of a rigid or substantially rigid material, such as a metal, e.g., stainless steel and/or Nitinol and/or etc.

In some embodiments, the groove of the safety release component can have a diameter greater than or equal to a diameter of the locking element(s).

In some embodiments, the proximal end of the safety release component can have a circular base portion defining a central bore and fixed with the distal end of the elongated tubular member.

In some embodiments, the safety release component can include a tubular portion extending from the circular base portion and defining an axial bore configured to accommodate the passage of a needle to and from a targeted insertion site.

In some embodiments, the groove defined by the outer surface of the tubular portion of the safety release component can extend toward the axial bore of the safety release component.

In some embodiments, the solid spherical elements of the safety release component can be configured to extend outwardly to engage with the annular groove of the catheter hub, thereby forming the locking engagement and tight fit relationship between the elongated tubular member and the catheter assembly when a needle is passed through the safety release component pursuant to puncturing a blood vessel of a patient.

In some embodiments, when the needle is retracted proximally through the safety release component after puncturing the blood vessel of a patient, the locking elements of the safety release component decouple from the annular groove defined by the catheter hub, thereby disengaging the safety release component (and needle guard assembly) from the catheter assembly. Disengagement of the safety release component from the catheter assembly allows separation of the catheter assembly from the needle guard assembly, but only after the distal tip of the needle has been fully enclosed within the safety release component.

In some embodiments, the safety release component included in the needle guard assembly can include a safety clip. The safety clip may bias outwardly to engage at least one interlocking flange defined in a body portion of the needle guard assembly. Outward biasing of the safety clip can allow a needle member to extend through the needle guard assembly and catheter hub. Upon withdrawal of the needle member from the proximal end of the catheter hub, the safety clip may disengage from the interlocking flange and enclose a tip portion of the needle member within the safety clip, thereby reducing the likelihood of needle prick injuries upon withdrawal of the needle member from the catheter hub.

In some embodiments, the safety clip may comprise a bracket defining an opening for receiving the needle member. A first resilient arm may extend from one end of the bracket and may have a connecting portion for engaging with the at least one portion with the at least one interlocking flange of the body portion and needle member. The first resilient arm can comprise a first section and a second section. A second resilient arm can extend from an opposing end of the bracket and can further comprise a connecting portion for engaging with the at least one interlocking flange of the body portion and the needle member. The second resilient arm can also include a first section and a second section, and the dimensions of the first section can be larger than the second section. The connecting portion of each of the first and second resilient arms can be configured to engage with the interlocking flange and a body portion of the needle member when the needle member is extending through the catheter hub en route to puncturing a patient's blood vessel. The connecting portion can disengage from the interlocking flange and body of the needle member when the needle member is withdrawn from the proximal end of the catheter hub.

In some embodiments, the connecting portion of each of the first and second resilient arms includes a curved protrusion at one end. The curved protrusion can be configured to engage with the at least one interlocking flange of the body portion and a curved lip segment. The curved lip segment can extend inwardly toward the bracket member and can be configured to engage with the needle member. The curved lip can be configured to enclose the tip portion of the needle member within the safety clip when the needle member is withdrawn from the proximal end of the catheter hub.

In some embodiments, the curved protrusion includes a projection extending towards the bracket. The projection, together with the second section of the first and second resilient arms, can define a seat portion, which can be configured to receive and seat the tip portion of the needle member, thereby preventing misalignment of the needle member during withdrawal from the catheter hub.

In some embodiments, the first resilient arm can be longer than the second resilient arm.

In some embodiments, at least one of the bracket, the first resilient arm, and/or the second resilient arm can be defined with at least one rib member for reinforcement.

In some embodiments, the rib member can be disposed at a second section of the first and second resilient arms to reinforce the first and second resilient arms.

In some embodiments, each of the at least one interlocking flange of the body portion extends radially inwardly for ensuring engagement with the safety clip in its biased configuration, so that the safety clip is retained within the needle guard assembly.

In some embodiments, the needle member can include a protuberance proximal to its distal end. The protuberance can be configured to engage with the bracket during withdrawal of the needle member from the proximal end of the catheter tube, thereby preventing release of the needle member from the needle guard assembly.

DETAILED DESCRIPTION

Provided herein are non-limiting embodiments of the present disclosure. References to specific embodiments and features are detailed throughout this disclosure, and examples are illustrated in the accompanying drawings. Reference numbers are included in the drawings to refer to the same or corresponding parts. References to various elements described herein are made collectively or individually when there may be more than one element of the same type; however, such references are merely exemplary in nature. Any reference to elements in singular form may also be construed to relate to plural form and vice-versa without limiting the scope of the disclosure to the exact number or type of such elements, unless set forth explicitly in the text.

As used herein, the term “proximal end” may refer to an end closer to the operator of a disclosed device. The term “distal end” as used herein may refer to an end opposite the “proximal end,” which may be closer to the patient being treated by a disclosed device. Accordingly, the terms “distal” or “distal end” and “proximal” or “proximal end” may refer to directions or ends which are respectively further from and closer to the operator inserting a catheter into the body of a patient.

As used herein, the terms “operator” and “user” may be used interchangeably and may include, but are not limited to, medical professionals and personnel, such as nurses or para-medical staff who may work under the direction and supervision of doctors, physicians, and/or surgeons, who may also be considered users or operators according to the embodiments described herein.

The terms “connected” or “fixedly connected” as used in the present disclosure may refer to components that may be attached to each other in a fixed manner, which may be permanent in the sense that disconnection would require specialized tools and/or excessive physical force. “Releasably connected” or “coupled” may refer to components that may be temporarily connected and disconnected via one or more device features. The term “slidably connected” may refer to components assembled together in such a manner that any one or more of the components can slide relative to the other(s) during device employment. The contact surfaces of the components may enable such sliding. The term “disposed” used herein may mean that a component or element of a device may be connected to another element such that a workable assembly is formed without hindering the functionality of each individual element. The term “comprising” means that a given device or components thereof may include additional components apart from the components explicitly identified herein.

This disclosure includes numeric terms and phrases such as “one or more,” “at least,” “a,” and “an.” The specific numbers associated with such terms should not be construed as limiting.

Terms defining shapes, e.g., “convex,” “frustoconical,” “flat,” “substantially flat,” “cylindrical,” “tubular,” “extended,” “circular,” “converging,” “diverging,” “tapered,” or “expanding” should also not be construed as limiting. A person of ordinary skill would recognize that these shapes allow for some variation, e.g., a “circular” shape, whether or not modified by a term such as “generally” or “substantially,” need not meet the theoretical definition of “circular” to be circular within the meaning of the term as used herein. Other shapes may be possible in certain embodiments. As such, a person of ordinary skill in the art may develop other shapes or shape combinations that preserve the workability of a disclosed device. Any of such alterations may still be encompassed within the present disclosure without departing from the invention.

The terminology used in the present disclosure includes the words specifically mentioned, derivatives thereof, and words of similar import. The embodiments illustrated below are not intended to be exhaustive or to limit the invention to the precise form disclosed. These embodiments are chosen and described to best explain the principles of the invention and its application, its practical use, and to enable others skilled in the art to best utilize and develop the invention.

FIGS.1and2illustrate a perspective view and a sectional view of a cannula100, respectively, according to embodiments of the present disclosure. The illustrated cannula100is a medical device that can be used to administer a fluid medication via intravenous therapy and/or remove bodily fluids, e.g., blood, from a patient for subsequent analysis. The particular type of cannula device disclosed herein may vary, as can the associated tasks performed therewith. In the illustrated figures, the cannula100is an intravenous cannula device. The term “intravenous cannula” is used interchangeably with “cannula” herein for brevity.

The cannula100illustrated inFIGS.1and2includes a catheter assembly102configured to reversibly couple with a needle hub, chamber, or guard assembly104. As shown inFIG.1, the catheter assembly102may be coupled with the needle guard assembly104, and, as shown inFIG.2, the catheter assembly102can be detached from the needle guard assembly104.

The catheter assembly102includes a catheter hub103fixed or coupled with a catheter tube106. Opposite a proximal end107of the catheter hub103, a needle108is shown projecting distally from a distal end109of the catheter tube106, which can be made of a flexible or soft material, non-limiting examples of which may include a plastic or polymer composition. In embodiments, other components of the catheter assembly102, such as the catheter hub103, can be made of a biocompatible material, which can be substantially rigid. In some examples, the proximal end107of the catheter hub103may be attached to, integrally formed with, or otherwise coupled with a larger catheter body member, such that the body member defines a coaxial recess or bore together with the catheter hub103. In such examples, the catheter body member may be directly coupled to the needle guard assembly104such that after coupling, the body member serves as a connector or adapter between the guard assembly104and the catheter assembly102. For ease of illustration, the catheter hub103is referred to as a single component herein.

The cannula100is configured such that the catheter assembly102can be decoupled from the needle guard assembly104after the needle108pierces a targeted blood vessel and is retracted proximally through catheter assembly102, thereby leaving at least a portion of the distal portion of the catheter assembly102within the blood vessel to facilitate the delivery and/or withdrawal of various medications and/or bodily fluids. As further described herein, embodiments of the cannula100can also be configured to prevent the backflow of blood after catheter placement via inclusion of a blood control valve therein. Embodiments of the cannula100also can be configured to prevent inadvertent needle prick injuries by fully enclosing the needle108, including its distal tip, within the needle guard assembly104after piercing a targeted blood vessel.

The catheter tube106defines an elongated, longitudinal bore through which the needle108can slide. The catheter tube106can be fixed with the catheter assembly102by a number of methods including, but not limited to, press fitting, adhesive bonding, or any other suitable method. In some examples, the catheter tube106may be formed integrally with the catheter assembly102. For gripping and manipulating the cannula100to reposition the catheter tube106during insertion and retraction of the needle108, a thumb grip110can also be included.

In the illustrated embodiment, the catheter assembly102further includes a dispensing cap112abutting an outer surface114of the catheter hub103. The dispensing cap112covers an outer port116, which can be utilized as an auxiliary fluid pathway fluidly coupled with a coaxial recess of the catheter assembly102. Accordingly, the intravenous cannula100can be adapted to have a two-way fluid mechanism. The dispensing cap112opens and closes the outer port116to allow the supply of a fluid. Such opening and closing can be implemented via a hinged or threaded mechanism in some examples.

Distal to the proximal end117of the needle guard assembly104, a luer lock member118can be included, which may be releasably coupled to the catheter assembly102, for example via complementary tapered portions. Any luer lock member of standard size or having the ISO standards which conforms with the catheter assembly102can be used in various embodiments. For example, the ISO standards ISO-80369-20 and ISO-80369-7 can be used for a luer lock member having a 6% universal taper. In additional embodiments, the luer lock member118may have other configurations or shapes, such as a luer slip.

As further shown inFIG.1, one or more wing members119can be attached or integrally formed with the catheter hub103. The wing member(s)119may aid in connecting or affixing the catheter assembly102to a patient's clothing or body part, e.g., a hand, after puncturing a vein or artery.

FIG.2is a cross-sectional view of the cannula100in which the catheter assembly102and needle guard assembly104are not currently coupled. As shown, the catheter assembly102can include a valve member120positioned inside a coaxial recess122of the catheter hub103. The valve member120may be tubular in shape, and may be referred to herein as the tubular valve member120, though other suitable configurations may be used. The tubular valve member120is configured to prevent or reduce the backflow of blood by closing after proximal retraction of the needle108therethrough. The catheter assembly102further includes an annular stopper124disposed within the coaxial recess122, where it abuts an inner surface of the catheter hub103. The tubular valve member120is adapted to be held in place within the coaxial recess122of the catheter assembly102via abutment of its proximal end with the annular stopper124. In some examples, the tubular valve member120is made of a flexible material, such as silicone or rubber. The annular stopper124may be integral with, connected to, or discrete from the valve member120.

Within an axial bore of the tubular valve member120is an actuator member126. As further described herein, distal movement of the actuator member126contributes to the opening of the tubular valve member120, which creates a passageway for fluid to flow distally through the catheter assembly102. A protrusion127defined by the inner surface of the tubular valve member120facilitates coordinated movement between the tubular valve member120and the actuator member126by engaging with a complementary, annular recess129defined by an outer surface of the actuator member126.

As further shown inFIG.2, the needle guard assembly104can include an elongated tubular member128and a needle hub130comprising a needle holder132. A guard assembly104gripping member or surface133may surround at least a portion of the elongated tubular member128. The needle holder132is disposed inside the elongated tubular member128, where a distal portion134of the needle holder132can be connected to the needle108. The elongated tubular member128may be sized to accommodate the entire length of the needle108, such that retraction of the needle108into the elongated tubular member128encloses and shields the distal tip of the needle108. The shape of the elongated tubular member128may vary, and may be cylindrical, rectangular, or any other suitable configuration.

The needle guard assembly104also includes a safety release component138fixed to a distal end140of the elongated tubular member128. The safety release component138can be releasably coupled to the catheter hub103of the catheter assembly102, such that, after such coupling, the catheter assembly102is coupled to the needle guard assembly104, with the safety release component138positioned between the proximal end107of the catheter hub103and the distal end140of the elongated tubular member128.

To facilitate coupling of the catheter assembly102with the needle guard assembly104, the catheter hub103includes a proximal cylindrical portion142defining an annular groove144at its inner surface146. The annular groove144of the proximal cylindrical portion142is complementary to, and thus configured to engage with, one or more locking elements148a,bof the safety release component138. The locking elements148a,bcan be inserted within the annular groove144only when the safety release component138is inserted within the coaxial recess122of the proximal cylindrical portion142and the needle108has been inserted within the safety release component138. By tightly mating with the catheter hub103upon insertion of the needle108therethrough, the safety release component138increases the catheter separation force, thereby reducing the likelihood of the catheter assembly102uncoupling from the needle guard assembly104while the needle108remains positioned within the catheter assembly102, in whole or in part. Likewise, upon retraction of the needle108proximally through the catheter assembly102, the safety release component138, and into the needle guard assembly104, the catheter release force is decreased significantly, such that detachment of the needle guard assembly104from the catheter assembly102requires a relatively small amount of force. This reduced catheter release force enables easy removal of the needle guard assembly104by an operator, which lessens the likelihood of perturbing the placement of the catheter assembly102within the patient. In the illustrated embodiment, the two locking elements148a,bare solid and spherical, but embodiments are not limited to solid, spherical locking elements. In lieu of grooves, notches, a ridge, or protrusions may be used.

The needle guard assembly104can also include or be coupled with a flashback chamber, an example of which is shown inFIG.13. Blood flow into the flashback chamber from a patient confirms successful puncturing of a vein or artery by the needle108. In embodiments, the needle hub130can serve as the flashback chamber. The needle hub130may also be telescopingly received within the elongated tubular member128, such that the two components can move relative to each other.

The magnified cross-sectional view of the catheter assembly102provided inFIG.3Ashows that the coaxial recess122of the catheter hub103can include an undercut portion150abutting a valve closure member152. An inner bore111extends through the catheter hub103along the axis indicated from X′ to X. In embodiments, a distal portion of the needle guard assembly104, e.g., the safety release component138, and/or a proximal portion of the catheter assembly102, e.g., the proximal cylindrical portion142, can include one or more radial seals configured to prevent entry and escape of fluids passing through or around the cannula100.

Multiple components of the cannula100can be configured to collectively control the flow of bodily fluids and medication therethrough. With respect to the delivery of fluids to a patient, for example, engagement of the luer lock member118with the proximal cylindrical portion142of the catheter hub103generates a force on the actuator member126along the longitudinal axis of the catheter hub103toward the distal end109of the cannula100. The safety release component138positioned at a distal end of the luer lock member118can be adapted to contact a proximal flange of the actuator member126, such that the actuator member126is displaced axially toward the distal end109of the cannula100. This axial displacement of the actuator member126opens a plurality of prongs of the tubular valve member120to form the fluid passage from a proximal end of the catheter hub103to the distal end109of the cannula100via an inner bore111of the catheter hub103. In embodiments, the proximal cylindrical portion142of the catheter hub103can be a female luer fitting defined by a tapered open mouth, which is configured to receive the luer lock member118of the needle guard assembly104.

FIG.3Billustrates a perspective view of the catheter hub103, including its proximal end107and distal end109. The inner bore111extends through the catheter hub103along the axis indicated from X′ to X. In some embodiments, the catheter hub103can be made of a biocompatible material that is rigid and configured to secure each component coupled thereto.

FIGS.4A and4Billustrate perspective and cross sectional views of an example of the actuator member126of the intravenous cannula100. As shown, the actuator member126can include a proximal first end154having a radially extending flange156, a distal second end158having a convex surface160, and an axial bore162extending from the first end154to the second end158. In embodiments, the actuator member126can be made of medical grade material such as, but not limited to, a rigid plastic material, e.g., polyoxymethylene (POM) or a metal, e.g., stainless steel or Nitinol.

As further shown in the illustrated embodiment, the actuator member126may also define an annular recess129extending around its outer surface166. The annular recess129is complementary to the protrusion127defined by the tubular valve member120, such that the protrusion127is configured to engage with the annular recess129. Engagement of the protrusion127defined by the tubular valve member120with the annular recess129of the actuator member126can maintain the coupling of the tubular valve member120with the actuator member126, thus forming an assembly inside the catheter hub103in which the two components move in unison and do not fall from the catheter hub103. In additional or alternative embodiments, the tubular valve member120and the actuator member126may be connected by other mechanisms, such as a threaded connection or snap fit mechanism. In some examples, the actuator member126can include a protrusion similar to that of protrusion127, and the tubular valve member120may include a recess similar to annular recess129of the actuator member126. The annular recess129and protrusion127should therefore not be viewed as limiting.

The proximal flange156of the actuator member126can be configured to receive a force from the luer lock member118in the distal direction, which causes the actuator member126to move axially toward the distal end109of the cannula100. Axial displacement of the actuator member126causes the tubular valve member120to open, thereby forming a fluid passageway from a proximal end of the catheter hub103to the distal end109of the cannula100.

An embodiment of the tubular valve member120is depicted inFIGS.5A,5B,5C, and5D. The tubular valve member120, which can be made of a flexible material selected from a non-limiting group of materials comprising silicone and rubber, is configured to fit within the coaxial recess122of the catheter hub103. In the example shown, the tubular valve member120is defined by a cylindrical portion168and a distal curved portion170. The cylindrical portion168of the tubular valve member120defines the protrusion127at its inner surface172, as shown inFIG.5B. The tubular valve member120defines a recess174configured to accommodate the actuator member126extending from its cylindrical portion168to the distal curved portion170. The recess may be coaxial and may be referred to herein as the coaxial recess174. In the illustrated embodiment, the distal curved portion170is convex to mate with the complementary convex surface160of the actuator member126shown inFIGS.4A and4B; however, the curved portion170may also be other shapes, e.g., flat (or generally flat), frustoconical, or any other suitable shape. The terms “curved portion” and “convex portion” are used interchangeably herein, and they may relate to the same portion of the tubular valve member120.

The convex portion170of the tubular valve member120includes one or more slits176, which together define a plurality of prongs178. The one or more slits176are designed to allow the needle108to pass therethrough and automatically close once the needle108is withdrawn, without the need for manually applied force. By self-healing in this manner, the slits176and prongs178of the convex distal surface170can prevent or minimize the backflow of blood through the tubular valve member120, and thus the catheter assembly102, when the needle108is withdrawn from the patient and retracted proximally through the coaxial recess174of the valve member120. The slits176can comprise various shapes, non-limiting examples of which can include a Y-shape, an inverted Y-shape, an X-shape, a horizontal slit, a vertical slit, a “+” shape, or any combination thereof, or any other shape which will facilitate opening and expanding of the plurality of prongs178during the insertion of the needle108and the actuator member126, respectively, inside the coaxial recess174of the tubular valve member120.

In the illustrated embodiment, the tubular valve member120is configured to be held in place within the coaxial recess122of the catheter hub103when a first, proximal end180of the tubular valve member120abuts the annular stopper124of the catheter hub103.

In operation, the needle108is passed through the coaxial recess122of the catheter hub103via the actuator member126, after which the needle108can pierce the slits176of the tubular valve member120. After passing through the slits176of the tubular valve member120, the needle108passes through and beyond the catheter tube106for puncturing a blood vessel of a patient.

When the needle108is withdrawn after puncturing the blood vessel, the slits176of the tubular valve member120may close without user engagement because the tubular valve member120is made of flexible material configured to self-close the opening at the slits176of the convex portion170of the tubular valve member120. Closure of the slits176can prevent the backflow of blood from the punctured blood vessel of a patient through the cannula such that after the needle108has been retracted and the catheter hub103released from the needle guard assembly104, the catheter assembly102remains in the vasculature to provide an access port. In this manner, the tubular valve member120can prevent blood from coming out of the catheter hub103after implantation of the catheter tube106but before another component is attached to the catheter hub103.

The particular shape of the tubular valve member120may vary. For example,FIGS.6A and6Bshow a tubular valve member having a distal surface that is flat, or substantially flat. Like tubular valve member120, the illustrated tubular valve member121is configured to be disposed within the coaxial recess122of the catheter hub103. The tubular valve member121is defined by a cylindrical portion169having a protrusion131at its inner surface173, which also defines a coaxial recess175. Opposite its proximal end181, the tubular valve member121has a flat distal surface171, which like the convex distal surface170of tubular valve member120, includes one or more slits177that together define a plurality of prongs179. The one or more slits177are designed to allow the needle108to pass therethrough, and the slits177can close automatically without user manipulation once the needle108is withdrawn. By self-healing in this manner, the slits177and prongs179of the flat distal surface171can also prevent or minimize the backflow of blood through the tubular valve member121, and thus the catheter assembly102, when the needle108is withdrawn from a patient and retracted proximally through the coaxial recess175of the valve member121.

FIGS.7A,7B,7C, and7Dillustrate various views of an embodiment of the valve closure member152of the intravenous cannula100. The valve closure member152includes a first surface182at its proximal end184, a second surface186at its distal end188, and a through-hole190extending from the proximal end184to the distal end188. The valve closure member152can be disposed inside the catheter hub103such that the second surface186of the valve closure member152abuts the undercut portion150of the catheter hub103and the first surface182of the valve closure member152abuts the distal portion of the tubular valve member120.

The valve closure member152can be configured to displace the prongs of the tubular valve member in a manner that closes or facilitates closing of the passage for fluid flow and prevents blood flow from the punctured blood vessel from the distal end109of the catheter tube106to the proximal end107of the catheter hub103when the luer lock member118abutting the actuator member126is removed.

In the illustrated embodiment, the valve closure member152is configured for use with tubular valve member120, such that the convex portion170of the tubular valve member120conforms to the shape of the first surface182of the valve closure member152. To accommodate differently shaped valve members, the valve closure member152may likewise have different shapes. For example, to accommodate tubular valve member121, the first surface182of the valve closure member may be flat or substantially flat. The first surface182of the valve closure member152may also be convex, even when used together with distally flat tubular valve member121. In non-limiting embodiments, the valve closure member152can have a hardness ranging from about 50 Shore to 80 Shore and the tubular valve member120can have a hardness ranging from about 20 Shore to 45 Shore. The plurality of prongs of the tubular valve member120/121can be more flexible relative to the valve closure member152, such that the plurality of prongs178/179may close by returning to their resting state automatically or with the aid of the valve closure member152when the needle108is withdrawn after puncturing of a blood vessel.

The cannula100disclosed herein can thus prevent the backflow of blood after needle retraction via coordinated movement and interactions between a tubular valve member, an actuator member, and/or a valve closure member. Notably, the disclosed valve closure member and the actuator member may be repeatedly activated and de-activated without wearing, such that replacement of one or both components is not necessary, at least not frequently.

As noted herein, the cannula100can also include a needle prick prevention mechanism configured to enclose the distal tip of the needle108within the needle guard assembly104before and after insertion of the needle108within a patient. Safety release component138, a cross section of which is shown in the needle guard assembly104depicted inFIG.8, is an example of a component of a needle prick safety device implemented in accordance with embodiments disclosed herein. The safety release component138can include two moveable locking elements148a,bconfigured to control the coupling of the catheter assembly102to the needle guard assembly104based on whether the needle108is present within either or both components. WhileFIG.8is shown with two moveable locking elements148a,b, one, three, or more moveable locking elements may be used.

FIG.9Ashows a close-up sectional view of the safety release component138and the surrounding features in an engaged, locked state with the proximal cylindrical portion142of the catheter hub103. As shown, the locking elements148a,bare each engaged or locked with a portion of the annular groove144defined by an inner surface146of the proximal cylindrical portion142of the catheter hub103. In this engaged state, the safety release component138is fixed to a distal end192of the elongated tubular member128and releasably connected to the proximal cylindrical portion142of the catheter hub103.

FIG.9Bis a perspective view of the safety release component138according to embodiments disclosed herein. The safety release component138comprises a first, proximal end194having a circular base portion196, which can be fixed to the distal end192of the elongated tubular member128. In some examples, the circular base portion196can be press-fitted to the elongated tubular member128, thereby unifying the two components. The safety release component138can also comprise a tubular portion198defining an axial bore200sized to accommodate passage of the needle108therethrough.

FIGS.9C and9Dshow the safety release component138in a disengaged or unlocked state relative to the catheter hub103at a snapshot in time during which the needle108is either being retracted proximally or extended distally, such that the needle tip208is momentarily positioned within the safety release component138, where the tip is fully enclosed. The needle tip208is not yet fully withdrawn into the needle guard assembly104, but is located in a safe, unexposed area within the safety release component138such that upon complete separation of the safety release component138(and needle guard assembly104) from the catheter hub103, the needle tip208may not cause accidental prick injuries. In the disengaged or unlocked state, the safety release component138may not be coupled with the catheter hub103or may at least not be locked with the catheter hub103but in the process of being separated therefrom, such that the safety release component138and needle guard assembly104to which it is attached may be readily separated in unison from the catheter assembly102by applying a small amount of tension force. As shown, the safety release component138can include one or more grooves202a,bdefined by the outer surface204of the tubular portion198. Each of the grooves202a,bis sized to accommodate one of locking elements148a,b. The solid, spherical locking elements can be in the form of stainless steel balls, but the disclosed embodiments are not limited thereto. The locking elements may be any suitable shape, including but not limited to spherical, generally spherical, prolate spheroid, cylindrical (with or without tabs or other elements to keep the locking elements in the grooves202a,b), conical, etc. The locking elements may be disconnected from and/or floating within the grooves, and/or they may be connected to or integral with the grooves, such as a shape tethered to a groove.

The diameter of each groove202a,bcan be substantially the same, or slightly greater, as the diameter of each corresponding locking element148a,b. The size of each groove202a,bfacilitates smooth movement of the locking elements148a,bradially outward when the needle108is passed through the axial bore200pursuant to puncturing a vein or artery, and radially inward after the subsequent withdrawal of the needle108from the patient and proximally through the safety release component138.

The locking elements148a,bof the safety release component138are configured to engage with the annular groove144of the catheter hub103, thereby forming a locking, tight-fit engagement between the elongated tubular member128of the needle guard assembly104and the catheter assembly102when the needle108is passed through the safety release component138for puncturing a vein or artery of a patient. The needle108thus displaces the locking elements148a,baway from the axial bore200and into the annular groove144to lock the catheter assembly102to the needle guard assembly104.FIG.9Dshows that, after withdrawing the needle108from the patient, through the catheter assembly102, and proximal to a distal end206of the needle guard assembly104, a distal tip208of the needle108can be nested within the safety release component138, at which time the locking engagement between the catheter hub103and needle guard assembly can be released. The disengagement occurs because the locking elements148a,bare able to be displaced inwardly, after retraction of the needle, from the annular groove144of the proximal cylindrical portion142of the catheter hub103, thereby disengaging the locking engagement between the elongated tubular member128and the catheter assembly102. Separation of the safety release component138from the catheter assembly102after nesting the needle tip208within the safety release component138allows the needle108to be withdrawn from a patient and removed from the catheter assembly102only when its distal tip208is concealed, thereby reducing the likelihood of needle prick injuries

Embodiments of the cannulas described herein can also include a mechanism for ensuring safe, reliable locking and unlocking of the needle guard assembly104in a manner that further reduces the likelihood of needle prick injuries.FIG.10is a cross-sectional view of an example of a portion of the needle guard assembly104configured in this manner. As shown, the interior of the needle guard assembly104can include a longitudinal notch210defining a proximal receiving area212. The notch210may further define a U-shaped slot detent cutout or notch214, which defines a pair of fingers216. Together, the fingers216define a narrow slot218. The fingers216can be configured to be urged away from each other to widen the slot218pursuant to locking the needle guard assembly104.

As illustrated together withFIG.2, the needle guard assembly104may be configured to have an injection position, in which the needle108extends beyond the distal end140of the needle guard assembly104, and a shielded position in which the distal tip208of the needle108is positioned proximal to the distal end140, nestled within the needle guard assembly104. To move the needle hub130from the injection position to the shielded position, the luer lock member118can be moved proximally, such that a projection or rib220also included within the needle guard assembly104moves proximally through the longitudinal notch210.

The proximal end of the rib220can define a ramp or camming surface222. In a resting state, i.e., before passage of the rib220therethrough, the slot218defined by the fingers216can be more narrow than the width or thickness of the rib220. As the needle hub130is moved proximally toward the shielded position, the camming surface222of the rib220engages the fingers216and urges them apart, thereby widening the slot218to allow passage of the rib220therethrough. Proximal movement of the rib220through the longitudinal notch210and beyond the fingers216is shown progressively inFIGS.11A,11B,11C, and11D.

As the fingers216are urged apart, the needle hub130enters a lock actuation stage in which the force generated by the camming action of the camming surface222against the fingers216exerts increased resistance to movement of the needle hub130. Entry into the lock actuation stage is shown inFIG.11Band passage through the lock actuation stage is shown inFIG.11C.

After the fingers216are urged apart to the extent necessary for the rib220to enter the slot218, the total force acting against the movement of the rib220is exerted by the sliding action of the fingers216against the rib220. This force decreases with continued proximal movement of the needle hub130, and thus the rib220, toward the shielded state, which is illustrated inFIGS.11D and11E.

Continued proximal movement of the needle hub130moves the rib gap224beyond the proximal end of the fingers216, thereby allowing the fingers216to snap back to their original non-flexed state in which the ends of the fingers216settle within the rib gap224. This configuration defines the locked, shielded state in which the needle108cannot be pushed distally without a high external force applied in the distal direction. To prevent additional proximal movement of the needle hub130relative to the elongated tubular member128, the camming surface222can extend to and contact the proximal end of the receiving area212.

In some examples, the cannula100can additionally or alternatively include a duckbill release mechanism at the distal end140of the needle guard assembly104, an example of which is shown inFIG.12. As shown, the duckbill release mechanism can include a pair of cooperating members, e.g., arms, each extending distally from the distal end140of the needle guard assembly104. The arms can be included in lieu of the moveable locking elements148a,bof the safety release component138disclosed herein. Like the safety release component138, the arms can be sized to fit within the proximal cylindrical portion142of the catheter hub103. The forces exerted upon entry into the lock actuation stage described in connection withFIGS.11A-11Dcan be exerted while the duckbill release mechanism secures the needle guard assembly104to the catheter insertion assembly102. The safety release component138and duckbill release mechanism may be included in separate embodiments, such that the two release mechanisms are not included in the same cannula.

The cooperating arms can define a passageway therebetween configured to slidably receive the needle108. One or both of the members may have a holding portion, such as a radially outward-protruding detent and/or radially inward extending recess configured for coupling with a complementary feature of the catheter hub103, which may be defined by the inner surface146of the proximal cylindrical portion142. Inclusion of the duckbill mechanism can ensure a strong coupling of the catheter assembly102with the needle guard assembly104when the needle108has been inserted therethrough. The duckbill mechanism may facilitate easy uncoupling of the catheter assembly102from the needle guard assembly104when the needle108is not present.

With reference again toFIG.12, an example of a duckbill mechanism included in some embodiments can include a distal cap226comprised of a nose228configured to be removably coupled with the proximal cylindrical portion142of the catheter hub103, such that the distal cap226abuts the inner surface146of the proximal cylindrical portion142. A pair of distally extending arms230,232defining a split cylinder are also sized to fit within the coaxial recess122of the catheter hub103. The arms230,232can flex radially toward each other upon receiving a compression force, but in the uncompressed, relaxed state, they can define a passageway234therebetween configured to slidably receive the needle108. Alternatively, the arms230,232can be biased inwardly toward one another and pushed into a parallel configuration when the needle is between them. The end of one or each arm230,232can include a holding portion in the form of a protrusion or detent236. The inclusion of one or more detents236defines one or more recesses238proximal thereto. The outer periphery240of the detents236can define an annular ring having a diameter that is at least slightly larger than the inner diameter of the proximal cylindrical portion142of the catheter hub103. In some examples, the detents236may be distally chamfered.

When the needle108is present in the passageway234between the arms230,232, compression of the arms230,232is impeded such that uncoupling of the distal cap226from the coaxial recess122of the catheter hub103requires considerable force, thereby reducing the likelihood of the catheter assembly102separating from the needle guard assembly104when the needle108remains within the catheter assembly102. Alternatively, when the arms are biased toward one another, retraction of the needle results in the arms moving toward one another, away from the catheter hub's interior walls.

Embodiments of the disclosed devices may include additional and/or alternative structures. As shown inFIGS.13-17, for example, a cannula300can include a safety clip302in addition to or instead of the aforementioned ball release mechanism to prevent accidental needle pricks. The cannula300can include a needle guard assembly304having a body portion306connected to a catheter hub308such that a projection310on the body portion306engages with a recess311in the catheter hub308. The body portion306of the needle guard assembly304defines an inner bore312configured for receiving the safety clip302. The safety clip302can be positioned within the body portion306such that the safety clip302engages with at least one interlocking flange314defined in the body portion306. In its resting, biased configuration, the safety clip302can allow a needle to extend through the body portion306and the catheter hub308. Upon withdrawal of the needle from the proximal end of the catheter hub308, the safety clip302can disengage from the interlocking flange314and enclose a tip portion316of the needle318within the catheter hub308, thereby preventing needle prick injuries during withdrawal of the needle318from a patient.

The body portion306can also feature a tubular sleeve320that extends axially from the catheter hub308up to a needle hub322, connected to the body portion306. The needle hub322is fixedly connected to the needle318and is in a tight-fit relationship with the body portion306. As such, when the needle318is withdrawn from the needle hub322, the needle hub322disengages from the body portion306and is withdrawn from the catheter hub308, the needle hub322disengages from the body portion306. Also, due to the construction of the safety clip302within the body portion306, the safety clip302also disengages from the body portion306and is withdrawn along with the needle318. As such, the tip portion316of the needle318is not exposed to the user during withdrawal of the needle318from a patient user. In some embodiments, the needle hub322may be provided with a thumb grip324for enabling a user to grip the cannula300during use.

The needle hub322can also be releasably coupled to a flow control hub326via an extended portion of the needle hub322. A proximal end of the needle hub322can be closed using a threaded cap or a luer lock. The flow control hub326may include a flashback chamber328, which may include a porous filter330and a cover to allow air to escape and blood to flow inside the flashback chamber328. The flashback chamber328may additionally include a hydrophobic filter for preventing spillage of the blood therefrom.

As further shown, a catheter tube332can be fixedly connected to the distal end333of the catheter hub308. The catheter tube332comprises a thin elongated tubular structure having a first chamber334. The bore of the catheter tube332can be configured to encase the needle318. The catheter hub308can also include an annular stopper336on an inner surface of the catheter hub308. The annular stopper336is disposed at the proximal end of the catheter hub308. In an embodiment, the luer lock cap is provided to seal the proximal end of the catheter hub308. The catheter hub308is adapted to accommodate a tubular valve member338within the coaxial recess340of the hub, abutting a valve closure member339. The tubular valve member338can define a flat distal surface. The tubular valve member338is configured to be held in place within the coaxial recess340of the catheter hub308when a first end of the tubular valve member338abuts the annular stopper336.

FIG.15is a perspective view of the actuator member346positioned within the cannula300in accordance with some embodiments of the present disclosure. The actuator member346includes a first end having a radially extending flange348, a second end having a convex surface350and an axial bore between the first end and the second end. The actuator member346can also define a circular recess342on an outer surface, such that a protrusion of the tubular valve member338(e.g., protrusion131) is configured to engage with the circular recess342. The engagement of the protrusion and the circular recess342of the actuator member346ensures that the tubular valve member338and the actuator member346remain coupled and secure within the catheter hub308.

FIG.16is a magnified perspective of the safety clip302. The safety clip302is configured to block entry of the needle318into the catheter hub308and retain the tip portion316of the needle318therein, when the needle318is withdrawn from the catheter hub308. The safety clip302includes a bracket352defining an opening354for receiving the needle318. The opening354may be sized based on the diameter of the needle318to be employed in the cannula300. The opening354allows the needle to move proximally through the safety clip302until the opening354reaches a bump, flattened portion, or protrusion near the distal end of the needle318that is larger than the opening354, so that the safety clip302cannot slide off the distal end of needle318. For example, the needle318can define a crimp355near its tip portion316. The crimp355in the needle318can include a pair of generally opposed, outwardly extending bulges355aand a pair of generally opposed, inwardly extending depressions355b, which are disposed generally orthogonally with respect to the bulges355a. The bulges355adefine the crimp355having a width, W, which is small enough to facilitate movement of the needle318within the cannula300, but large enough to prevent passage of the distal end of the needle318through the opening354.

A first resilient arm356extends from one end of the bracket352and has a first section358and a second section360, and the dimensions of the first section358may be larger than the dimensions of the second section360in some embodiments. As an example, the first section358may be wider that the second section360. Such a construction of the safety clip302renders effortless and inexpensive manufacturing of the safety clip302, while ensuring sufficient spring force or biasing spring force requirements. The first section358may further conform to the dimensions of the bracket352and thus ensure uniformity in construction, which retains the structural rigidity of the safety clip302when subjected to deformation.

A second resilient arm362extends from another end of the bracket352and has a first section364and a second section366, and the dimensions of the first section364may be larger than the second section366in some embodiments. As an example, the first section364may be wider than the second section366. Such a construction of the safety clip302renders effortless and inexpensive manufacturing of the safety clip302, while ensuring sufficient spring force or biasing force requirements. The first section364may further conform to the dimensions of the bracket352and thus ensure uniformity in construction, which retains the structural rigidity of the safety clip302when subjected to deformation.

A connection portion368is also included, preferably at the second section360. The connection portion368is configured to engage with at least one interlocking flange314configured on an inner surface of the body portion306and the needle318. The connection portion368is configured to engage with the interlocking flange314and a body370of the needle318for puncturing the vein of the subject. The connection portion368further disengages from the interlocking flange314and the body370of the needle318when the needle318is withdrawn from the proximal end372of the catheter hub308.

The connection portion368includes a curved protrusion374at a fore end and a curved lip376at an aft end. The curved protrusion374is configured to engage with the interlocking flange314of the body portion306, so that the safety clip302is held within the body portion306. The curved lip376provided at the aft end extends inwardly toward the bracket352and is configured to engage the needle318.

The curved protrusion374engages with the interlocking flange314due to biasing of the first and second resilient arms356,362. The first and second resilient arms356,362are biased or flexed due to insertion of the needle318into the catheter hub308. Insertion or presence of the needle318into the needle guard assembly304urges the first and second resilient arms356,362to flex away from each other, thereby engaging the curved protrusion374to engage with the interlocking flange314. At the same time, the curved lip376engages with the body370of the needle318, so that the biasing force is maintained and the safety clip302is retained within the body portion306.

In some embodiments, the curved protrusion374of the first and second arms356,362are outwardly extending protrusions configured for engaging the interlocking flange314in the body portion306, which are inwardly protruding. Accordingly, the construction or shape or configuration of the curved protrusion374may be selected based on the construction of the interlocking flanges314, so that interlocking therebetween is ensured when the needle318is present in the catheter hub308.

In another embodiment, the curved lip376of the first and second arms356,362may comprise inwardly extending protrusions configured for engaging with the needle318when the needle318is present within the catheter hub308, and enclose the tip portion316of the needle318within the safety clip302when the needle318is withdrawn from the catheter hub308. As such, the curved lip376is configured to prevent entry or re-entry of the needle318beyond the safety clip302, when the needle318is withdrawn from the catheter hub308. Accordingly, the construction or shape or configuration of the curved lip376may be selected based on the configuration of the needle318or the position at which the needle is inserted or withdrawn. As one non-limiting example, the curved protrusion374may be an inverted U-shaped member, while the curved lip376may be a U-shaped member.

Further, the curved protrusion374on each of the first and the second arms356,362, can include a projection378extending toward the bracket352. The projection378along with the second section of the respective arms defines a seat portion380. The seat portion380is adapted to receive and seat the tip portion316of the needle318, which may ensure that the tip portion316of the needle318rests within the safety clip302, thereby preventing misalignment of the needle318during withdrawal from the catheter hub308or during disposal of the needle318.

In an embodiment, the first resilient arm356is longer than the second resilient arm362. Such a construction of the arms356,362may be provided to ensure that sufficient biasing force is exerted onto the interlocking flanges314during use, thereby ensuring that the safety clip302is sufficiently retained within the body portion306. Also, asymmetric lengths of the arms may ensure contact of the connection portion368on the body370of the needle318about the same plane. Such an engagement may ensure uniform stress-distribution on the needle318, thereby preventing damage during assembly. In an embodiment, the needle318may be assembled into the catheter hub308in the body portion306by initially flexing the arms356,362and thereafter inserting the needle318through the tubular sleeve320.

Further, each of the bracket352and the first and the second resilient arms356,362may be defined with at least one rib member382. The rib member382reinforces the safety clip302, which improves its overall strength. As an example, the rib member382may extend about the surface of the bracket352. The rib member382may also extend along the second sections of the first and the second arms356,362, which inherently improves the strength of the second sections. The length of extension of the rib member382may be configured based on the strength or rigidity requirements of the safety clip302. In an embodiment, the rib member382may be formed on the bracket352and/or the arms via conventional manufacturing techniques such as punching and the like.

In an embodiment, the rib member382may be provided on the bracket352as a reinforcement, in order to prevent damage to the bracket352via contact of a protuberance on the needle318during removal of the needle318. Such a construction ensures that the needle318is retained within the safety clip302upon withdrawal. In some embodiments, the rib member382may be made of a metallic material, a plastic material, a composite material, or any other material which serves the purpose of providing reinforcement to the safety clip302.

In an embodiment, the bracket352and the first and the second arms356,362may be made of metallic material or any other material which serves the purpose of ensuring interlocking with the body portion306when the needle318is present within the catheter hub308, and encloses the tip portion316within when the needle318is withdrawn from the catheter hub308.

When the needle318is withdrawn after puncturing the vein, the slits of the tubular valve member will close since the tubular valve member is made of flexible material which can self-close the opening at the slits of the flat portion of the valve member. Additionally, once the tip portion316of the needle318is withdrawn from the proximal end372, particularly, beyond the connection portion368of the arms356,362of the safety clip302, the biasing force acting on the arms356,362due to contact with the needle318ceases. As such, the arms retract to an unbiased configuration, during which the curved lip376completely closes the path for the tip portion316to move forward and beyond the safety clip302. Thus, the safety clip302retains the needle318upon withdrawal from the catheter hub308. In this scenario, the safety clip302may be withdrawn from the body portion306along with the needle318via the needle hub322.

The tip portion316rests on the seat portion380configured on the safety clip302, and thus the alignment of the needle318is maintained, irrespective of movement of the needle318during withdrawal. Therefore, exposure of the tip portion316of the needle318is prevented and the likelihood of needle prick injuries reduced. In embodiments, the tip portion316may selectively rest on any of the seat portion380configured on the first and second arms356,362.

The disclosed intravenous cannula devices can prevent a patient's blood from contacting a user's hand(s) because the reverse, proximal flow of blood is blocked upon closure of the disclosed prongs of the tubular valve member. Blood-based infections and physical injuries may therefore be prevented as a result.

The disclosed intravenous cannula devices may be less expensive than alternative devices because the tubular valve member, the actuator member, and the valve closure member can be made of inexpensive plastic or bio-compatible material.

The disclosed intravenous cannula devices can provide improved closing of the slits defined by the tubular valve member because the plurality of prongs of the tubular valve member can be closed quickly and reliably via the pushing force acting towards the proximal end of the catheter hub by the valve closure member, thereby closing the internal fluid passage defined by the device without allowing reverse flow of blood.

The disclosed cannula devices may prevent the tip of the needle from contacting a user after withdrawing the needle. For instance, the disclosed needle safety components provide a safety mechanism in the form of one or more safety release components that shield the tip of the needle when the needle is withdraw after piercing a blood vessel of a patient.

The disclosed locking elements, which can include solid spherical balls in some examples, provide selective disengagement of a catheter assembly from a needle guard assembly upon proximal retraction of the needle into the needle guard assembly, thereby preventing exposure of needle tip and needle prick injuries commonly associated therewith.

The disclosed locking elements comprising solid spherical balls enable the easy removal of the needle by unlocking the locking engagement of the catheter assembly and needle guard assembly.

The disclosed devices can include or be compatible with various types of catheter hubs, including but not limited to hubs103-A,103-B, and103-C shown inFIG.18,FIG.19andFIG.20, respectively. The disclosed tubular valve members, actuator members, and valve closure members, among other components, may therefore not be limited to cannulas having the catheter hubs represented inFIGS.1and13.

Embodiments described herein may also be configured to have additional or alternative needle release and retraction mechanisms. For example, embodiments of the disclosed cannulas can include a coiled spring biased to retract the needle proximally, such that the needle is automatically retracted and enclosed within the needle guard assembly after and before its deployment. Embodiments may also feature a push-button mechanism configured to facilitate release and retraction of the needle, and/or to facilitate coupling and uncoupling of the catheter assembly with the needle guard assembly. Embodiments may include a manually operable push-button protruding from, or accessible at, a surface of a cannula, extending outwardly from the needle guard assembly in some examples. Actuation of the push-button may be necessary to overcome a spring force biasing the needle in the proximal direction, within the needle guard assembly. Outward displacement of the push-button may allow the internal components of the needle guard assembly, e.g., the needle hub, to move distally in unison with the needle attached thereto. Examples of spring-biased, push-button activated cannula configurations compatible with one or more of the disclosed embodiments are described in U.S. Pat. No. 4,747,831, the entire contents of which are incorporated by reference herein.

While aspects of the present invention have been particularly shown and described with reference to the embodiments above, it will be understood by those skilled in the art that various additional embodiments may be contemplated by modification of the disclosed device without departing from the scope of what is disclosed. Such embodiments should be understood to fall within the scope of the present invention as determined based upon claims and any equivalents thereof.