EP3268076A1 - Katheteranordnungen mit durchflussregelventilmechanismen und zugehörige verfahren - Google Patents

Katheteranordnungen mit durchflussregelventilmechanismen und zugehörige verfahren

Info

Publication number
EP3268076A1
EP3268076A1 EP16709373.1A EP16709373A EP3268076A1 EP 3268076 A1 EP3268076 A1 EP 3268076A1 EP 16709373 A EP16709373 A EP 16709373A EP 3268076 A1 EP3268076 A1 EP 3268076A1
Authority
EP
European Patent Office
Prior art keywords
valve
catheter
interior cavity
port
catheter hub
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP16709373.1A
Other languages
English (en)
French (fr)
Inventor
Chee Mun Phang
Siew Ping Lim
Riduan BIN TAJUDIN
Soo Yong Tan
Hui Kuun Teoh
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
B Braun Melsungen AG
Original Assignee
B Braun Melsungen AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by B Braun Melsungen AG filed Critical B Braun Melsungen AG
Publication of EP3268076A1 publication Critical patent/EP3268076A1/de
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0606—"Over-the-needle" catheter assemblies, e.g. I.V. catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0097—Catheters; Hollow probes characterised by the hub
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0612—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
    • A61M25/0637—Butterfly or winged devices, e.g. for facilitating handling or for attachment to the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M39/26—Valves closing automatically on disconnecting the line and opening on reconnection thereof

Definitions

  • the present disclosure generally relates to intravenous catheters and more particularly to intravenous catheters with injection ports having aspiration and/or injection capabilities with valve mechanisms and related methods.
  • IV catheterization After intravenous (IV) catheterization, it may be necessary to deliver a solution such as an anesthetic through the catheter hub to the patient.
  • a solution such as an anesthetic
  • One point of delivery is at an injection port integrated with the catheter hub of the IV catheter which has an inlet at a proximal end and the catheter hub is commonly referred to as a ported catheter.
  • the catheter hub is typically secured to the patient by taping the catheter hub to the patient's skin using IV dressing and/or medical tape.
  • IV solution flows into a proximal end of the catheter hub and out a distal end of the catheter hub through a catheter tube and into the patient's vein.
  • the injection port extends radially from the catheter hub and allows delivery of medicament into the solution stream without interrupting the flow of IV solution or requiring removal or assembly of parts which could cause discomfort to the patient.
  • a port cap assembly is often fitted onto the injection port to maintain cleanliness.
  • a ported catheter assembly comprising: a catheter hub having a distal end, an interior cavity, a proximal end, and a lengthwise axis extending between the proximal and distal ends; an injection port extending radially from the catheter hub and having a lumen communicating with the interior cavity of the catheter hub; a catheter tube extending from the distal end of the catheter hub; and a valve secured in the interior cavity of the catheter hub, the valve comprising both a port valve and an inlet valve comprising a split septum, wherein the port valve comprises a cylindrical body and forms a seal between the lumen of the injection port and the interior cavity of the catheter hub; and a bore defined by the cylindrical body communicating with the split septum.
  • the ported catheter assembly can further comprise a securing ring coupled to the valve and engaging a step in the interior cavity of the catheter hub to secure the valve to the interior cavity of the catheter hub.
  • the ported catheter wherein the inlet valve can comprise a mushroom head with at least one opening.
  • the ported catheter assembly can further comprise a septum formed with the mushroom head.
  • the ported catheter assembly wherein the inlet valve can comprise a tapered wall forming a conical shaped body.
  • the ported catheter assembly wherein a web can connect a cylindrical body of the valve and to the tapered wall.
  • the ported catheter assembly wherein at least one opening of the split septum can open to permit flow through the bore of the cylindrical body when the mushroom head is pressed by a male medical implement.
  • the ported catheter assembly can further comprise a needle guard removably coupled to the valve.
  • the ported catheter assembly wherein the needle guard can be positioned partially inside the catheter hub and partially outside the catheter hub.
  • the ported catheter assembly wherein the needle guard portion that is partially outside the catheter hub can be completely or partially covered by a shroud on the needle hub.
  • the ported catheter assembly can further comprise a septum ring on the inlet valve comprising a groove and a recess, and wherein a free end of the needle guard is removably secured in the recess.
  • valve can further comprise an elastic neck located proximally of the port valve comprising a collapsible section.
  • the ported catheter assembly wherein the inlet valve can comprise a first conical section and a second conical section that is axially movable towards the first conical section when pressed by a male medical implement.
  • the ported catheter assembly wherein the second conical section can move at least partially into a shaped gap when pressed by a male medical implement.
  • the ported catheter assembly can further comprise a valve opener located in the injection port.
  • Aspect of the present disclosure further include a method of making the ported catheter assembly.
  • the method can comprise: providing a catheter hub with a catheter body having a distal end, a proximal end, and a lengthwise axis extending between the two ends; an injection port extending from the catheter body in a radial direction; said injection port comprising a lumen communicating with an interior cavity of the catheter hub; attaching a catheter tube to the distal end of the catheter hub; securing a valve in the interior cavity of the catheter hub, the valve comprising both a port valve and an inlet valve comprising a split septum; and wherein the port valve is collapsible by fluid pressure or by physical contact and the inlet valve comprises a slit that opens when a proximal end of the inlet valve is distally displace by a male medical implement.
  • a still further aspect of the present disclosure is a ported catheter assembly, comprising: a catheter hub having a distal end, an interior cavity, and a proximal end; an injection port extending from the catheter hub and having a lumen communicating with the interior cavity of the catheter hub; a catheter tube extending from the distal end of the catheter hub; and a valve comprising a first seal between the lumen of the port and the interior cavity of the catheter hub and a second seal between the proximal end and distal end of the catheter hub.
  • a ported catheter assembly comprising: a catheter hub having a distal end, an interior cavity, and a proximal end; an injection port extending from the catheter hub and having a lumen communicating with the interior cavity of the catheter hub; a catheter tube extending from the distal end of the catheter hub; and a valve located in the catheter hub.
  • the catheter hub can have a catheter body and an injection port.
  • the injection port can extend from the catheter body.
  • the catheter body can be called a ported catheter.
  • the injection port can be unitarily formed with the catheter body and can extend directly inline or along the same axis as the catheter body or be formed off-axis from the catheter body.
  • the catheter body and port can be made from a number of prior art thermoplastic material, such as by plastic injection.
  • a port cap assembly can cap the injection port.
  • a valve can be disposed in the interior of the catheter body.
  • the valve can control or restrict the flow of fluids through the injection port.
  • the valve can also control or restrict the flow of fluids through the catheter hub.
  • the valve can be made from a one-piece or from multiple pieces.
  • the valve can have one or more slits.
  • the valve can be actuated with a valve actuator or directly without a valve actuator, such as when pushed by a male Luer tip.
  • a catheter tube can extend distally from the catheter hub.
  • a needle can project from a needle hub through the catheter hub and through the catheter tube with a sharp distal tip of the needle extending out the catheter tube.
  • the needle hub can have a flashback chamber with a vent plug at a proximal end thereof.
  • the catheter hub can have a catheter body with a proximal end, a distal end, and an interior cavity formed therebetween.
  • a proximal end of the catheter tube can be attached to the catheter body by a bushing.
  • the bushing can be attached at the distal end inside the interior cavity of the catheter hub to secure the catheter tube to the catheter hub.
  • the bushing can form a seal with the catheter hub to prevent fluid from leaking out the distal end of the catheter hub.
  • a lengthwise axis of the catheter hub and a lengthwise axis of the injection port can be perpendicular to each other.
  • the lengthwise axis of the catheter hub and the lengthwise axis of the injection port can be located off-axis to each other.
  • the lengthwise axis of the catheter hub and the lengthwise axis of the injection port can intersect each other.
  • a pair of wings can extend from the catheter body.
  • the interior cavity or lumen of the catheter body can be in fluid communication with the injection port 15.
  • the proximal end of the catheter body can have a female Luer with external threads to matingly receive a male Luer connector, an IV line, a Luer access connector, a syringe tip, a vent plug, connectors, or IV devices.
  • the injection port can have a port body defining a lumen in fluid communication with the interior cavity of the catheter body depending on the position or state of the valve.
  • the lumen of the injection port can be incorporated with a Luer taper for receiving a male medical implement in a Luer fit arrangement.
  • External threads can be incorporated to the exterior of the injection port at an outer surface surrounding the inlet of the injection port for a Luer lock arrangement.
  • the injection port can have a relatively lower height measured from the base of the injection port with the catheter body to an upper perimeter of the injection port to accommodate a standard male medical implement.
  • the male medical implement can extend into the lumen of the injection port to directly press against the valve to open the valve, such as by directly pressing against, such as physically pressing against, the valve with a tip or a distal end of the male medical implement.
  • the tip of the male medical implement can be spaced from the valve and fluid pressure discharged from the male medical implement collapses the valve to open the valve.
  • the male medical implement can discharge fluid through the injection port and generate a vacuum to draw a sample into the syringe. For example, while the male medical implement directly presses against the valve to collapse the valve or to open the valve, a vacuum can be drawn through the injection port and into the male medical implement.
  • the male medical implement can directly press against a distal section of the valve without using a separate valve actuator or opener located inside the injection port.
  • the injection port can be unitarily formed to the catheter body.
  • the injection port can be formed by plastic injection molding.
  • the injection port can be attached to the catheter body by welding, fusing, or other attachment means to integrate the two structures as a single integral unit.
  • the injection port can be made from two or more port sections assembled together with the catheter body.
  • the injection port can be assembled by welding or snap-fit arrangement.
  • the catheter body can be made from two or more assembled hub sections.
  • the injection port and the catheter body can be made of the same biocompatible material.
  • a valve opener can be placed in the lumen of the injection port prior to assembling the port sections together.
  • the valve opener for use with the injection port can be an extension or a conduit with flow passage or passages, between a male medical tip and the valve located inside the interior cavity of the catheter hub.
  • the valve opener can advance into the lumen of the injection port to physically press against the valve to collapse the valve to open a fluid pathway to permit fluid flow out the male medical tip and through the injection port or for flow to flow into the male medical tip via the injection port.
  • the valve opener can be elastically deformed and forced into the injection port without resorting to a multi-port section configuration.
  • a lip or shoulder can be provided inside the injection port, away from the opening of the port, to retain the valve opener.
  • the valve can seal the lumen of the injection port from the main body and seal the proximal opening of the main body to prevent flow through the valve.
  • the valve can be made from an elastomeric or a thermoplastic elastomer (TPE) material
  • the valve can have a port valve and an inlet valve comprising a split septum proximal of the port valve.
  • the port valve and the inlet valve can be unitarily formed as a one-piece valve or formed separately and subsequently joined or combined to form a single integrated valve.
  • the port valve and the inlet valve can be welded, glued, or joined using a snap fit arrangement in which one component is slid into another component.
  • the valve may be made using an elastic biocompatible material.
  • the valve can be made from a silicone material.
  • the valve can be formed from two or more different components made from different materials with different material properties and/or different durometers.
  • the valve can have a generally cylindrical body extending between an open distal end and a proximal end.
  • a bore can be defined between the open distal end and the proximal end to permit fluid communication thereacross and for the open distal end to communicate with the split septum of the inlet valve.
  • the split septum can be selectively open to allow a flow path to flow between the distal end and the proximal end of the valve.
  • the port valve can seal off the interface between the lumen of the injection port and the interior cavity of the catheter body by presenting a surface, when in the normal expanded state, that covers the opening at the interface between the lumen of the injection and the interior cavity to prevent fluid from entering the interior cavity from the injection port.
  • the surface of the port valve can also prevent fluid from passing through the interior cavity from either the distal end or the proximal end of the catheter body from entering the lumen.
  • the port valve can be sized and shaped to be received within the interior cavity of the catheter body, or sized slightly larger in diameter than the interior cavity to provide a tight fit inside the interior cavity and at the opening between the lumen of the injection port and the interior cavity.
  • the inlet valve can comprise a tapered wall with conical shaped structure joined to a web.
  • the conical shaped structure can have an apex pointing in the distal direction towards the catheter tube when mounted inside the catheter hub.
  • the web can also be tapered with or without the same draft angle as the tapered wall.
  • An opening, such as one or more slits, can form through the tapered wall to define the split septum.
  • the web can be located distally of the tapered wall.
  • the apex can be located distally of the web.
  • the opening can be a single axial slit formed through the tapered wall to define two flaps, two or more axial slits formed through the tapered wall to define multiple flaps, or a simple hole formed through the apex.
  • the web can be formed at an end edge of the cylindrical body and integrated with the tapered wall of the inlet valve.
  • the web and the tapered wall can resemble barbs on a barb fitting.
  • the inlet valve can comprise a first conical section formed at least in part by the web and a second conical section formed at least in part by the tapered wall.
  • the second conical section can move distally towards the first conical section.
  • a shaped gap can be provided between the web and the tapered wall, partly bounded by the end edge of the cylindrical body and the septum ring.
  • the second conical section can be configured to advance distally into the shaped gap when activated by a male medical implement.
  • the opening of the split septum can substantially seal upon itself or around a needle located inside the catheter hub and catheter tube.
  • the opening can maintain a seal against backflow in the direction from the distal end towards the split septum.
  • the conical shaped structure of the split septum can readily seal upon itself when exposed to fluid back pressure. Fluid pressure against the exterior conical wall surface of the split septum can press the conical shaped wall inwardly along the lengthwise axis of the valve thereby forming a tighter seal at the one or more seams or slits.
  • the compression of the wall surface of the inlet valve can cause the seam or seams of the opening to further compress to form a tight seal.
  • the conical shaped wall surface can have an interior wall surface defining a funnel shaped inlet for funneling fluid through the split septum in a distal direction.
  • the tapered wall can extends into a septum ring or flange.
  • the septum ring or flange can have a generally planar end surface and an interior perimeter defining an opening.
  • the septum flange can be connected to the tapered wall, and have a conical shaped exterior surface and interior surface that converges to an apex pointing in the direction of the distal end of the catheter hub when mounted therein.
  • the web can join the tapered wall at a location proximal of the apex.
  • the septum ring can have an outside diameter similar to an outside diameter of the circular edge with different diameters contemplated.
  • the septum ring can have a smaller outside diameter than the interior bore of the catheter body so that when the inlet valve is actuated by a medical implement, the smaller outside diameter of the septum ring does not drag, or only slightly drags, against the interior bore when pressed by a male medical implement.
  • An optional securing ring can be mounted to an exterior of the cylindrical body of the valve.
  • the securing ring can be made from a more rigid or harder material than the material of the valve.
  • the securing ring can be made from a metal material or from a plastic material.
  • the securing ring can have a generally flat exterior and interior surfaces or contours to grip around an exterior of the cylindrical body.
  • the securing ring can have a toroid shape with rounded contours.
  • the securing ring can have a stepped shoulder.
  • the exterior surface of the securing ring may be planar or flat or stepped to form a shoulder.
  • the valve can be secured inside the interior cavity of the catheter body using the securing ring press fitted in the interior cavity and coupled to the valve.
  • the securing ring can prevent the valve from moving axially, either distally and/or proximally, in the catheter body.
  • the securing ring can prevent the port valve portion of the valve from moving distally or proximally in the interior cavity from a set positon to ensure proper sealing of the fluid opening between the lumen of the injection port and the interior cavity of the catheter body.
  • the securing ring can seat against a step or shoulder formed in the interior cavity of the catheter hub.
  • the securing ring can have a mating step on an exterior surface thereof to positively engage the step in the interior cavity of the catheter body to prevent the securing ring from moving axially inside the interior cavity, which, because of its engagement with the valve, can also prevent the valve from moving axially inside the interior cavity.
  • Portions of the valve can move or collapse when pressed by a male medical implement.
  • An inwardly extending lip of the securing ring can engage a notch in the outer surface of the cylindrical body of the port valve to couple the securing ring to the valve.
  • Engagement between the securing ring and the valve can also involve using tapered surfaces, similar to a Luer connection.
  • the securing ring can be made of metal or other high strength material.
  • the securing ring can have a single planar interior surface pressed fit around the valve and a single planar exterior surface pressed fit to the interior wall surfaces of the catheter body without stepped surfaces, without a securing lip, and without a notch.
  • the inside opening dimension of the securing ring can compress against the exterior of the valve.
  • the smaller outside diameter portion of the securing ring can slide more readily inside the interior cavity of the catheter hub during installation without drag.
  • the entire exterior surface of the securing ring may not rub against the interior surface of the catheter hub, except for a sub-section thereof due to the other section of the securing ring being stepped down in size.
  • a third hub having a tip guard for covering the needle tip following successful venipuncture can be provided between the catheter hub and the needle hub.
  • the third hub can be entirely proximal of the catheter hub or can have a small overlapping portion with the catheter hub.
  • a finger can extend from the third hub into a proximal opening of the catheter hub to retain the two in a ready to use position.
  • the needle guard can also be placed completely or partially within the interior of the catheter hub, without needing a third hub or third housing.
  • the needle guard can be provided with the needle hub so that following successful venipuncture, the needle along with the needle tip can be retracted into the needle hub, such as by spring action.
  • a needle guard can be engaged inside the catheter hub until the needle tip is retracted inside the needle guard.
  • the needle guard can have arms that move or collapse to block the needle tip while disengaging from the inside of the catheter hub.
  • the needle can have a change in contour proximal of the needle tip to engage a perimeter defining an opening in a proximal wall of the needle guard.
  • the change in contour can be a crimp or a bulge or other structure in which a cross-sectional dimension is larger than the largest diameter of the opening to be engaged by the change in contour.
  • the injection port of the catheter hub can have external threads at the outer surface surrounding the inlet of the injection port.
  • the injection port can be sized and shaped to accommodate a Luer tip of a medical implement with or without a threaded collar for engaging the external threads on the injection port.
  • the tip of the male medical implement can be inserted into the inlet of the injection port and extend into the lumen a known amount or distance that can readily be sized and computed.
  • the distal end of the Luer tip can be spaced from the port valve depending on the injection port height.
  • a valve opener can be used if the tip is spaced from the port valve.
  • the injection port can be sized so that the male Luer tip directly contacts and presses against the port valve when the male medical implement is inserted into the injection port.
  • Fluids stored within the male medical implement can be injected through the lumen of the injection port, the interior cavity of the catheter hub, and the catheter tube to the patient.
  • fluid pressure generated presses on the exterior wall of the port valve and collapses the port valve without the tip directly pressing against the port valve or without a valve opener pressing against the port valve. Fluid pressure therefore can break the seal between the lumen and the interior cavity so that fluid can pass to the patient through the catheter tube.
  • valve can close the opening into the injection port and not permit fluid flow.
  • a valve opener can be disposed inside the lumen of the injection port, between the distal end of the tip and the valve.
  • the valve opener can be sized and shaped to advance against the valve by the pressing action of the distal end of the tip of the male medical implement to press against the wall surface of the port valve to collapse the port valve and open the fluid pathway between the injection port and the interior bore of the catheter hub.
  • the valve opener may be used to advance against and physically deform the port valve to break the seal and allow fluid to pass from the male medical implement into the patient via the injection port.
  • a vacuum can be applied or generated at the lumen of the injection port while still maintaining the port valve in the collapsed state with the valve opener, such as to take a sample or draw in fluid into the male medical implement.
  • the injection port can be sized so that the tip of the male medical implement directly physically collapses the port valve without a valve opener.
  • a valve opener can be generally elongated with a surface for engaging the tip of the male medical implement and a surface that can press against the valve from the injection port to collapse the port valve.
  • One or more fluid pathways may be provided with the valve opener for fluid flow across the valve opener.
  • an aspect of the present disclosure is understood to include a ported catheter assembly and wherein a fluid sample can be taken or aspirated through the injection port, which is spaced from the proximal opening of the catheter body.
  • a valve opener may be located inside the injection port and advanced against the port valve by a medical implement to collapse the port valve, thereby breaking the seal at the injection port so that fluids can be injected or aspirated through the injection port.
  • the length of the injection port can be reduced to enable the tip of the male medical implement to physically deform the port valve without a valve opener.
  • the port valve can elastically return back to its original shape thereby restoring the seal between the lumen of the injection port and the interior cavity of the catheter body.
  • the valve opener and the interior bore of the injection port can also be configured so that a resilient component of the valve opener presses against the interior bore to move away from the valve as the physical constraint is removed.
  • the lumen of the injection port is no longer in fluid communication with the interior cavity of the catheter body when a seal is formed by the expanded port valve.
  • a port valve of a valve can elastically spring back to its original cylindrical shape.
  • a valve opener can move away from the port valve once the physical constraint or restrain is removed at the inlet of the injection port.
  • the tip of the medical implement can physically collapse the port valve without the need for a valve opener, by pressing and physically deforming the port valve to open the port for fluid flow.
  • the valve can be further understood to include an inlet valve.
  • the inlet valve can have one or more slits and tapered surfaces.
  • the inlet valve can block flow through the proximal opening of the catheter hub body.
  • the valve can be collapsed at or near the open distal end of the cylindrical body of the valve, such as due to fluid pressure, due to a part or portion of a valve opener pressing against the cylindrical body to collapse the cylindrical body, or due to the tip of a male medical implement pressing against the cylindrical body of the valve to collapse the cylindrical body.
  • Fluid back pressure can push the split septum towards the proximal end of the catheter body, against the tapered conical wall surface.
  • the pressure can further compress the opening of the split septum to form a tighter seal or seals along one or more seams because of the conical shape contour of the split septum.
  • Back flow of fluid can come from fluid injection delivery through the injection port and/or back pressure from venous pressure from the patient through the catheter tube.
  • the valve can include a port valve but not an inlet valve, which can be opened or has an unobstructed lumen.
  • the vale has both a port valve and an inlet valve.
  • An axially extending force applied in the distal direction on the septum ring can cause the second conical section to move distally closer to the first conical section, and partially or completely into the shaped gap between the first and second conical sections.
  • the opening at the apex can be expanded, thereby breaking the seal to allow fluids stored within the male medical implement to flow through the opening, the open bore of the port valve, the interior cavity of the catheter body, and out the catheter tube to the patient.
  • the opening can expand due at least in part to the first conical section being pushed distally by the second conical section but because the web of the first conical section is held by the cylindrical body, the web mostly expands radially outwardly away from the lengthwise axis of the valve to cause the seam of the split septum to open the opening.
  • the port valve at the distal end of the valve does not move distally when the valve is pressed by the male medical implement at the proximal end because of the step formed in the interior cavity of the catheter hub preventing the securing ring attached to the valve from moving distally. This ensures only the split septum can be pressed distally when the second conical section moves against the first conical section to expand the opening without moving the entire valve.
  • a pressed fit arrangement between the securing ring and the interior surface of the catheter hub can be sufficient to retain the valve in place when the inlet valve is actuated by a medical implement. If no securing ring is provided, the valve body may be pressed fit into the bore of the catheter hub using tapered geometries, shoulders, or stepped surfaces between the catheter hub and the valve to secure the valve without a separate securing ring.
  • the elasticity of the valve may allow the web and the wall of the first and second conical sections to elastically return from their deflected positions to their un-deflected position or closed position to close the split septum and close the fluid pathway between the interior cavity of the catheter hub body and the proximal inlet.
  • the valve can include a port valve and an inlet valve.
  • the inlet valve can comprise a split septum located proximal of the port valve.
  • the inlet valve can seal the bore from the open proximal end of the hub body and the port valve can seal the lumen of the injection port from the interior cavity of the catheter body.
  • the valve can have a split septum, which has one or more slits that can define an opening which opens when pressed against in a distal direction by a male medical implement.
  • the slits can form a plus "+" or a "Y” like pattern at the tip.
  • the port valve can be actuated to open by fluid pressure, by a tip of a male medical implement, or by a valve actuator located inside the injection port.
  • the valve can have a proximal tip or head comprising a septum ring. As shown, the tip can resemble a mushroom head comprising a semi-spherical dome.
  • the proximal tip of the inlet valve can alternatively comprise an open opening and a split septum located distally of the proximal opening.
  • the port valve can be connected to the inlet valve by an elastic neck or neck section.
  • the elastic neck can be hollow and have a generally constant inside diameter and an outside diameter that varies along the length of the elastic neck.
  • the valve can have a variable wall thickness along at least a portion of the length of the elastic neck.
  • the elastic neck can have a generally constant outside diameter and an interior diameter that varies to form a variable wall thickness along at least a portion of the length of the neck section.
  • the wall thickness can be generally constant along the entire length the neck section.
  • the wall thickness can be generally constant at the connection point with the tip.
  • variable wall thickness of the neck section can have a collapsible region that compresses when the tip is pressed by a male medical implement to open the split septum.
  • the valve can have only the elastic neck and the tip collapses when pushed by a male medical implement to open the inlet valve.
  • the valve can have only the collapsible region of the elastic neck collapse.
  • the generally constant thickness section can collapse when axially loaded.
  • a tip having an arc surface may or may not distort and/or flatten when pressed by a male medical implement to open the inlet valve.
  • the cylindrical body with the port valve can be stiffer than the elastic neck to allow the elastic neck to elastically deform towards the port valve.
  • the securing ring can fix sections of the valve distal of the securing ring from moving and/or collapsing in the axial direction due to the distally directed force of a male medical implement acting on the inlet valve.
  • the entire valve can have the same or similar stiffness as the neck section and can still compress by a male medical implement to open the inlet valve while the port valve is held steady and uncompressed by a securing ring.
  • the opening can be a hole or one or more slits communicating with the open bore of the port valve. Prior to activation, the opening of the split septum can be sealed against itself or around a needle passing therethrough in a ready position for venipuncture.
  • the seam or seams defining the opening may be formed in a post-mold operation.
  • the seam or seams can be formed by cutting.
  • the outside diameter of the septum ring can be larger than the interior bore of the catheter hub and can be squeezed by the interior bore of the catheter hub to assist in closing the opening of the inlet valve.
  • the inwardly extending lip of the securing ring can engages a notch in the outer surface of the cylindrical body to couple and secure the valve to the interior cavity of the catheter body.
  • a step can be formed on an exterior surface of the securing ring to abut a step formed in the interior cavity of the catheter body to prevent the securing ring and the valve attached to the securing ring from axial movement, except when the valve is compressed to be opened by a medical implement or by pressure, a male Luer tip, or a valve opener to open the valve.
  • the port valve can seal off the interface between the lumen of the injection port and the interior cavity of the catheter body by forming a seal to prevent fluid from entering the interior cavity from the injection port, and also prevents fluid from passing through the injection port from the interior cavity.
  • the port valve can have a shape matching a shape of the interior cavity of the catheter body, or slightly larger, such as a larger diameter, so that the interior cavity can provide a tight fit inside the interior cavity.
  • the proximal end of the catheter body can be sized and shaped to accommodate a Luer tip with or without a threaded collar for engaging external threads at the outer surface of the catheter body surrounding the inlet of the catheter body at the proximal end.
  • the tip of the male Luer lock can be inserted into the inlet of the catheter body and extend into the interior cavity of the catheter body a known amount or distance.
  • the distal end of the male tip can press against the dome head of the inlet valve and displace the septum ring distally by elastically deforming and compressing the elastic neck thereby breaking the seal and stretching the opening of the split septum to allow fluid stored within the male medical implement to flow through the interior cavity of the catheter body and the catheter tube to the patient.
  • the catheter assembly or needle device of the present embodiment can include just the catheter hub, catheter tube, needle hub, and needle and optionally any of the various other components discussed elsewhere herein.
  • the valve can comprise a tip attached to an elastic neck, which is attached to a cylindrical body.
  • the cylindrical body can further comprise a port valve for closing a flow space between an injection port and the interior cavity of the catheter hub.
  • the tip and the neck of the inlet valve can deform to open a slit located on the tip, which opens to permit fluid flow through the valve.
  • the tip can comprise a semi-spherical dome surface resembling a mushroom head and having a slit formed through the wall surface of the dome.
  • the slit may have a simple straight line, a complex line, or a plus "+" configuration.
  • a securing ring can be used to secure the valve inside the bore of a catheter hub.
  • the securing ring may be omitted and the valve may be pressed fit into the bore without the securing ring.
  • the elasticity of the valve can allow the elastic neck and the tip to recoil or expand from their collapsed position back to their expanded or closed position to close the fluid pathway through the inlet of the catheter hub.
  • the valve can include a port valve and an inlet valve with a split septum.
  • the inlet valve can be positioned proximally of the port valve and have an opening and a tapered wall connected to a web.
  • the web and the tapered wall can define surface features of the split septum, which can have an apex projecting in the distal direction towards the port valve.
  • One or more recesses or notches can be provided with the septum ring and one or more grooves can be provided between the tapered wall and the septum ring.
  • the groove may have a "V-shape" cross-section or a "U-shaped” cross-section with straight or tapered sidewalls for retaining a hook of a needle guard.
  • a securing ring may be used to secure the valve within an interior bore of a ported catheter hub.
  • An inwardly extending lip of the securing ring can engage a notch formed in the outer surface of the cylindrical body to couple and secure the valve to the interior cavity of the catheter body.
  • the port valve can have an open bore that permits fluid communication with the split septum.
  • a shroud on a needle hub can be attached to the proximal end of the catheter hub.
  • the proximal end of the catheter hub can project into an open space defined by the shroud of the needle hub.
  • the two hubs can connect or engage through a plurality of deflectable fingers with projections fitting against recess sections formed with the catheter hub.
  • a coupler can secure the needle hub and the catheter hub together.
  • the coupler can separate from the catheter hub or the needle hub and remain with the other one of the catheter hub or needle hub.
  • the needle can extend from a nose section of the needle hub and passes through a safety clip or needle guard, the valve, the catheter hub, and the catheter tube with the sharp distal tip of the needle extending out a distal end of the catheter tube in a ready to use position.
  • the proximal end of the catheter body can have a female Luer connector with external threads to engage one or more projections formed with the shroud of the needle hub.
  • the needle guard can have a proximal wall, a perimeter defining an opening through the proximal wall, and two arms extending distally of the proximal wall and engaging the valve.
  • Each of the two arms can comprise a distal wall having a curved lip or hook at a free end.
  • the arms can have different lengths so that when the needle guard is activated, the two distal walls are axially offset.
  • the two arms can intersect one another when viewed from a side.
  • the two arms can alternatively extend distally of a proximal wall on different sides of the needle and not cross one another when viewed from a side.
  • One of the free ends of the arms can contact the valve while the other of the free ends can contact the needle shaft in the ready position.
  • One of the free ends of one of the arms can extend through the recess of the septum ring so that the hook of that arm interacts with the groove located between the septum ring and the tapered wall.
  • the hook can contact the groove at a location of the groove distal the recess on the septum ring.
  • the groove can hold at least one of the arms spaced apart from the needle thereby holding the needle guard in place until the needle is retracted proximally from the catheter hub.
  • the elastic material of the tapered wall can be compressed or squeezed due to the presence of the needle through the valve to prevent the hook from dislodging from the groove. Because the tapered wall is pressed outwardly, the arm having the hook in the groove, can also be pressed outwardly which leaves less gap between the arm and the interior cavity wall of the catheter body thereby restricting the amount of movement of the arm outwardly and reduce or eliminate the possibility of the hook dislodging from the groove.
  • the inlet valve can be modified to support both arms so that both arms are spaced from the needle in a ready to use position.
  • the inlet valve can be extended and provided with two grooves and two recesses on the septum ring to support both free ends of the needle guard. Both arms can then be held apart from the needle to reduce friction to the needle as the needle retracts proximally following successful venipuncture.
  • One or both free ends of the two arms can have a simple straight edge without the curved lip or hook.
  • the two arms can each have folded tabs to reinforce the two distal ends and prevent the needle from moving laterally outside the arms.
  • the needle guard can be partially located within the interior cavity of the catheter hub with portions of the needle guard located exteriorly of the catheter hub.
  • the needle guard outside of the catheter hub can be wholly or partially covered by the shroud.
  • the opening of the split septum can close and seal a fluid pathway through the valve when the needle is retracted proximally from the catheter tube and the valve following successful venipuncture.
  • the shroud of the needle hub can separate from the catheter hub when the needle and needle hub are retracted proximally.
  • the change in profile such as a bulge or a crimp
  • the change in profile is too large to pass through the opening and pulls on the needle guard in the proximal direction to separate the needle guard from the valve.
  • the needle guard can be made from a metal material.
  • a sleeve can be included with the needle guard to space the two distal walls of the needle guard from the needle shaft in a ready to use position.
  • the sleeve can be slidable relative to the needle guard.
  • the hook of one of the arms can be pulled out from the groove and pass through the recess on the septum ring during the retraction process.
  • the arm without the hook engaged in the groove can begin to close over the tip of the needle and the hook engaged in the groove can be pulled out proximally more readily because the tapered wall on the valve is no longer compressed. Because the tapered wall is no longer pressed outwardly, the arm having the hook in the groove, is no longer pressed outwardly which can leave more gap between the arm and the interior cavity wall of the catheter body to dislodge the hook from the groove.
  • the arms can move radially to block the needle tip from un-intended needle sticks after removal of the needle guard and the needle from the catheter hub.
  • a male medical connector can be coupled directly or indirectly to the proximal end of the catheter hub to infuse fluids into the patient.
  • FIG. 1 is an exploded isometric view of one embodiment of a ported catheter assembly
  • FIG. 2 is a top view of the ported catheter assembly shown without a port cap assembly.
  • FIG. 3 is a side view of the ported catheter assembly
  • FIG. 4 is a top cross sectional view of the ported catheter assembly shown with a first embodiment of a valve;
  • FIG. 5A is a detailed view of the circled portion 5A-5A of the ported catheter assembly in FIG. 4;
  • FIG. 5B is a detailed view of the circled portion 5B-5B of the ported catheter assembly in FIG. 5A;
  • FIG. 6 is an isometric view of the valve of FIG. 4 in a closed position, prior to activation to permit fluid flow;
  • FIG. 7A is an end cross sectional view of the ported catheter assembly shown with the valve of FIG. 4 taken along a central axis of the injection port and shown with a male medical implement;
  • FIG. 7B is a top cross sectional view of the ported catheter assembly shown with the valve of FIG. 4 taken along a central axis of the catheter hub assembly;
  • FIG. 7C is an isometric view of the valve of FIG. 4 with the port valve in the open position and with an optional securing ring;
  • FIG. 8 is a top cross sectional view of the ported catheter assembly, similar to FIG. 5A, shown with the port valve in the open position;
  • FIG. 9A is a top cross sectional view of the ported catheter assembly, similar to FIG. 4, shown with the opening of the inlet valve actuated to permit fluid flow;
  • FIG. 9B is an isometric view of the valve with the inlet valve in the opened position but shown without the catheter hub or the male medical implement for clarity;
  • FIG. 9C is a detailed view of the circled portion 9C-9C of the ported catheter assembly of
  • FIG. 9A is a diagrammatic representation of FIG. 9A.
  • FIG. 10 is an isometric view of a second embodiment of a valve having an optional securing ring
  • FIG. 11 is a side cross sectional view of the valve and the securing ring of FIG. 10;
  • FIG. 12 is a top cross sectional view of a ported catheter assembly shown with the valve of FIG. 10, taken along a central axis of the catheter hub;
  • FIG. 13 is a top cross sectional view of the ported catheter assembly, similar to FIG. 12, shown with the inlet valve actuated for fluid flow;
  • FIG. 14 is an isometric view of the valve of FIG. 13 in the opened position but shown without the catheter hub and the male medical implement for clarity;
  • FIG. 15 is an isometric view of a third embodiment of a valve provided in accordance with aspects of the present disclosure shown with an optional securing ring;
  • FIG. 16 is a side cross sectional view of the valve of FIG. 15 with the securing ring;
  • FIG. 17 is a side cross sectional view of a ported catheter assembly having a needle guard and a needle passing through the needle guard and the valve of FIG. 15;
  • FIG. 18 is a side cross sectional view of the ported catheter assembly of FIG. 17 shown with the needle hub and the needle in the process of retracting away from the catheter hub and a change in profile about to contact a proximal wall of the needle guard;
  • FIG. 19 is a side cross sectional view of the ported catheter assembly of FIG. 18 shown with the change in profile engaging a perimeter on the needle guard and retracting the needle guard away from the catheter hub.
  • a ported catheter assembly 100 comprising a catheter hub 10 having a catheter body 11 and an injection port 15 extending from the catheter body 11, a port cap assembly 30 capping the injection port 15, a valve 50 disposed in the interior of the catheter body 11 to control or restrict the flow of fluids through the injection port 15 and through the proximal opening of the catheter hub 10, and a catheter tube 40 attached to and extending distally from the catheter hub 10.
  • the ported catheter assembly 100 is shown without a needle hub and a needle for inserting the catheter tube 40 into a patient, which are understood to be part of the present catheter assembly.
  • a needle normally projects from a needle hub through the catheter hub and through the catheter tube with the sharp distal tip of the needle extending out the distal opening of the catheter tube to facilitate puncturing the skin and placing the catheter tube inside a vein during venipuncture.
  • the needle hub has a flashback chamber and is typically equipped with a vent plug at a proximal end thereof.
  • the catheter hub 10 has a catheter body 11 with a proximal end 12, a distal end 14, and an interior cavity 13 formed therebetween.
  • the distal end of the catheter hub 10 is generally toward the tip of the catheter tube 40 and the proximal end is generally toward the needle hub, typically closer to the practitioner.
  • the catheter tube 40 and the catheter hub 10 provide a fluid pathway to facilitate delivery of fluids or retrieval of fluids, such as for aspirating blood samples, from within the patient.
  • a distal end of the catheter tube 40 is inserted into the patient and a proximal end of the catheter tube 40 is attached to the catheter body 11 by a bushing 45.
  • the bushing 45 is attached at the distal end 14 inside the interior cavity 13 of the catheter hub 10 to secure the catheter tube 40 to the catheter hub 10.
  • the bushing 45 can also form a seal with the catheter hub 10 to prevent fluid from leaking out the distal end 14 of the catheter hub 10.
  • the catheter hub 10 is configured for use with an intravenous tubing at a proximal end 12 thereof to facilitate delivery of fluids into or removal of fluids from the patient. For example, when the catheter 40 is inserted into the patient, solution such as saline solution and/or medication can flow from the proximal end 12 of the catheter hub 10 to the catheter tube 40 without leakage.
  • the catheter hub 10 has a lengthwise axis and the injection port 15 has a lengthwise axis that is perpendicular to and located off-axis to the lengthwise axis. In other words, the two angled axes do not intersect.
  • the axis of the injection port 15 intersects the axis of the catheter hub 10, such as being in-line, and can be at a right angle therefrom, as further discussed below.
  • a pair of wings 19 extends from the catheter body 11 for use to secure and stabilize the ported catheter assembly 100 to the patient following catheterization.
  • the interior cavity 13 or lumen of the catheter body 11 is selectively in fluid communication with the injection port 15, as further discussed below.
  • the proximal end 12 of the catheter body 11 has a female Luer with external threads.
  • the female Luer connector is thus configured to matingly receive a male Luer connector, such as an IV line, a Luer access connector, a syringe tip, a vent plug, another known connector, or future-developed IV devices.
  • a male Luer connector such as an IV line, a Luer access connector, a syringe tip, a vent plug, another known connector, or future-developed IV devices.
  • Each of these components can be sized and configured in conformity with at least some of the International Standards Organization (ISO) standards for female and male Luer connections under current or future standards. For discussion purposes, any one of these components or the class of these components may be referred to as a male medical implement.
  • ISO International Standards Organization
  • the injection port 15 is configured for bolus injection, such as by receiving a syringe tip and medicament displaced by a syringe, and can further be configured for withdrawing fluid, such as blood, from the patient.
  • the injection port 15 has a port body 32 defining a lumen 150, which can be in fluid communication with the interior cavity 13 of the catheter body 11 depending on the position or state of the valve 50, as further discussed below.
  • the lumen 150 of the injection port 15 is incorporated with a Luer taper for receiving a male medical implement in a Luer fit arrangement.
  • external threads are incorporated to the exterior of the injection port 15 at an outer surface 21 surrounding the inlet 20 of the injection port 15 for a Luer lock arrangement.
  • the injection port 15 has a relatively lower height measured from the base of the injection port 15 with the catheter body 11 to an upper perimeter of the injection port 15 to accommodate a standard male medical implement, such as a syringe tip with a male Luer. But because of the shortened length, the syringe tip can extend deep into the lumen 150 of the injection port 15 to directly press against the valve 50 to open the valve 50, as further discussed below. This allows the syringe to not only discharge fluid through the injection port 15 but also allows a vacuum to be pulled to draw a sample into the syringe.
  • the injection port 15 is unitarily formed to the catheter body 11, such as by plastic injection molding.
  • the injection port 15 is attached to the catheter body 11 by welding, fusing, or other attachment means to integrate the two structures as a single integral unit.
  • the injection port 15 is made from two or more port sections that are assembled together, such as by welding or snap-fit arrangement.
  • the catheter body 11 can similarly be made from two or more assembled hub sections.
  • the injection port 15 and the catheter body are made of the same biocompatible material.
  • a valve opener (not shown) can be placed in the lumen 150 of the injection port 15 prior to assembling the port sections together.
  • the valve opener When incorporated, the valve opener provides a go between mechanism, such as an extension or a conduit with flow passage or passages, between a male medical tip and the valve 50 located inside the interior cavity 13 of the catheter hub 10.
  • the valve opener located inside the injection port 15 is pressed or pushed by the male medical tip, the valve opener advances further into the lumen 150 of the injection port to physically press against the valve 50 to collapse the valve 50, which then opens a fluid pathway to permit fluid flow out the male medical tip and through the injection port 15 or for flow to flow into the male medical tip, such as when drawing a sample.
  • the valve opener can be elastically deformed and forced into the injection port without resorting to a multi-port section configuration.
  • the catheter assembly 10 can have an offset injection port 15, such as having an axis that is axially offset from the lengthwise axis of the catheter body 11, or a centered injection port 15, such as an axially in-line arrangement.
  • the valve 50 is capable of sealing the lumen 150 of the injection port 15 from the main body 11 and sealing the proximal opening 12 of the main body 11 to prevent flow through the valve 50.
  • the valve 50 is made from an elastomeric or a thermoplastic elastomer (TPE) material and includes a port valve 51 and an inlet valve 49 comprising a split septum 53 proximal of the port valve 51.
  • TPE thermoplastic elastomer
  • the valve 50 because it has a port valve 51 component and an inlet valve 49 component, may be referred to as a combination valve, a dual function valve, or a combined valve.
  • the port valve 51 and the inlet valve 49 are unitarily formed as a one-piece valve 50.
  • the port valve 51 and the inlet valve 49 can be formed separately and subsequently joined or combined to form a single integrated valve 50.
  • the port valve 51 and the inlet valve 49 can be welded, glued, or joined using a snap fit arrangement in which one component is slid into another component.
  • the valve 50 may be made using an elastic biocompatible material.
  • the valve 50 is made from a silicone material.
  • the different components can be made from different material properties, such as different material types and/or different durometers.
  • the valve 50 has a generally cylindrical body 36 extending between an open distal end 34 and a proximal end 38.
  • a bore 110 defined between the two ends 34, 38 permits fluid communication thereacross and for the open distal end 34 to communicate with the split septum 53 of the inlet valve 49.
  • the split septum 53 can be selectively open to allow a flow path to flow between the two ends 34, 38.
  • the port valve 51 seals off the interface between the lumen 150 of the injection port 15 and the interior cavity 13 of the catheter body 11 by presenting a surface, when in the normal expanded state, that covers the opening at the interface between the lumen 150 and the interior cavity 13 to prevent fluid from entering the interior cavity 13 from the injection port 15.
  • the surface of the port valve 51 also prevents fluid from passing through the interior cavity 13 from either the distal end 14 or the proximal end 12 of the catheter body 11 from entering the lumen 150.
  • the port valve 51 is sized and shaped to be received within the interior cavity 13 of the catheter body 11, but can be sized slightly larger, such as larger in diameter, than the interior cavity 13 to provide a tight fit inside the interior cavity 13 and particularly at the opening between the lumen 150 and the interior cavity 13.
  • the inlet valve 49 comprises a tapered wall 114 with conical shaped structure joined to a web 118 and having an apex 112 pointing in the distal direction towards the catheter tube 40 when mounted inside the catheter hub 10.
  • the web 118 is also tapered and may or may not have the same draft angle as the tapered wall 114.
  • An opening 54 such as one or more slits, forms through the tapered wall 114 to define the split septum 53.
  • the opening 54 is a single axial slit formed through tapered wall 114 to define two flaps.
  • the opening 54 is two or more axial slits formed through the tapered wall 114 to define multiple flaps.
  • the opening 54 is a simple hole formed through the apex 112.
  • the web 118 is formed at an end edge 52 of the cylindrical body 36 and integrated with the tapered wall 114 of the inlet valve 49. As shown in in the side cross-section of FIG. 5A, the web 118 and the tapered wall 114 resemble barbs on a barb fitting.
  • the inlet valve 49 can be understood as comprising a first conical section 400 formed at least in part by the web 118 and a second conical section 402 formed at least in part by the tapered wall 114. As further discussed below, the second conical section 402 is configured to move distally towards the first conical section 400.
  • a shaped gap 120 is provided between the web 118 and the tapered wall 114, partly bounded by the end edge 52 of the cylindrical body 36 and the septum ring 57.
  • the second conical section 402 is configured to advance distally into the shaped gap 120 when activated by a male medical implement.
  • a male medical implement Prior to activation, such as by a male Luer adaptor or a syringe tip, the opening 54 of the split septum 53 is substantially sealed upon itself. If a needle is located inside the catheter hub 10 and catheter tube 40, such as before venipuncture, the opening 54 is sealed around the needle.
  • the opening 54 can maintain a seal against backflow in the direction from the distal end 14 towards the split septum 53, such as due to fluid flow through the injection port 15 or blood flow from the catheter tube 40.
  • the conical shaped structure of the split septum 53 readily seals upon itself when exposed to fluid back pressure.
  • the split septum 53 is conical shaped with the apex 112 pointing distally, fluid pressure pressing against the exterior conical wall surface 114 of the split septum 53 presses the conical shaped wall inwardly along the lengthwise axis of the valve 50 thereby forming a tighter seal at the one or more seams or slits.
  • compression of the wall surface 114 of the inlet valve 49 causes the seam or seams of the opening 54 to further compress to form a tight seal.
  • the conical shaped wall surface 114 has an interior wall surface 56 defining a funnel shaped inlet for funneling fluid through the split septum in a distal direction, such as when receiving fluid from an IV line or a syringe.
  • the tapered wall 114 extends into a septum ring or septum flange 57, which has a generally planar end surface 122 and an interior perimeter defining an opening 124.
  • the septum flange 57 is connected to a wall structure, such as to the tapered wall 114, having a conical shaped exterior surface and interior surface that converges to an apex 112 pointing in the direction of the distal end of the catheter hub when mounted therein.
  • the septum ring 57 can have an outside diameter similar to an outside diameter of the circular edge 52 with different diameters contemplated.
  • the septum ring 57 can have a smaller outside diameter than the interior bore of the catheter body 11 so that when the inlet valve 49 is actuated by a medical implement, the smaller outside diameter of the septum ring 57 does not drag, or possibly only slightly drags, against the interior bore when pressed by a male medical implement.
  • a securing ring 60 is provided with the valve 50, such as mounted to an exterior of the cylindrical body 36 of the valve 50.
  • the securing ring 60 has a generally flat exterior and interior surfaces or contours to grip around an exterior of the cylindrical body 36.
  • the securing ring 60 has a toroid shape with rounded contours.
  • the exterior surface of the securing ring 60 may be planar or flat or is stepped 60a to form a shoulder.
  • the valve 50 is secured inside the interior cavity 13 of the catheter body 11 using the securing ring 60 press fitted in the interior cavity 13 and coupled to the valve 50.
  • the securing ring 60 prevents the valve 50 from moving axially, either distally and/or proximally, in the catheter body 11.
  • the securing ring 60 prevents the port valve 51 portion of the valve 50 from moving distally or proximally in the interior cavity 13 from a set positon to ensure proper sealing of the fluid opening 130 between the lumen 150 of the injection port and the interior cavity 13 of the catheter body 11.
  • a step 16 is formed in the interior cavity 13 of the catheter hub 10, which may also be referred to as a shoulder.
  • the step 16 provides a secure point for the securing ring 60 to seat against, which has a mating step 60a on an exterior surface thereof to seat against the step 16 in the interior cavity 13 of the catheter body 11.
  • the two step surfaces 16, 60a define a positive engagement that prevent the securing ring 60 from moving axially inside the interior cavity 13, which, because of its engagement with the valve 50, prevents the valve 50 from moving axially inside the interior cavity 13.
  • portions of the valve 50 can move, such as collapse.
  • an inwardly extending lip 61 of the securing ring 60 engages a notch 58 in the outer surface of the cylindrical body 36 of the port valve 51 to couple the securing ring 60 to the valve 50.
  • the lip 61 and the notch 58 are omitted.
  • Engagement between the securing ring 60 and the valve 50 can also involve using tapered surfaces, similar to a Luer connection.
  • the securing ring 60 can be made of metal or other high strength material.
  • the securing ring 60 has a single planar interior surface that is pressed fit around the valve 50 and a single planar exterior surface that is pressed fit to the interior wall surfaces of the catheter body 11 without stepped surfaces, without a securing lip and without a notch.
  • the smaller outside diameter portion of the securing ring 60 can slide more readily inside the interior cavity 13 of the catheter hub 10 during installation without drag.
  • the entire exterior surface of the securing ring 60 does not rub against the interior surface of the catheter hub 10, only a sub-section thereof due to the other section of the securing ring 60 being stepped down in size.
  • an aspect of the present disclosure is understood to include a ported catheter hub 10 with a catheter tube 40, a needle projecting through the catheter tube 40 with the needle tip extending distally of the distal opening of the catheter tube 40, and a needle hub attached to the needle and located proximally of the catheter hub 10.
  • a valve 50 is located in the interior of the catheter hub 10. The valve 50 is configured to seal the injection port form the interior cavity 13 of the catheter hub 10 and configured to seal the proximal end 12 of the catheter hub 10 from fluid flow through the valve 50.
  • a third hub having a tip guard for covering the needle tip following successful venipuncture is provided between the catheter hub 10 and the needle hub.
  • the needle guard can instead be placed inside the needle hub, such as completely or partially within the interior of the catheter hub 10, without a third hub or third housing.
  • the needle guard is provided with the needle hub so that following successful venipuncture, the needle along with the needle tip is retracted into the needle hub, such as by spring action.
  • a needle guard is engaged inside the catheter hub 10 until the needle tip is retracted inside the needle guard which then has arms that move or collapse to block the needle tip while disengaging from the inside of the catheter hub 10.
  • the needle can have a change in contour proximal of the needle tip to engage a perimeter defining an opening in a proximal wall of the needle guard.
  • the change in contour can be a crimp or a bulge or other structure in which a cross-sectional dimension is larger than the largest diameter of the opening to be engaged by the change in contour.
  • FIGS. 7A and 7B are cross-sectional views of the ported catheter assembly 100.
  • the injection port 15 of the catheter hub 10 has external threads (not shown) at the outer surface 21 surrounding the inlet 20 of the injection port 15.
  • the injection port 15 is sized and shaped to accommodate a Luer tip of a medical implement 132 with or without a threaded collar for engaging the external threads on the injection port 15.
  • the tip 134 of the male medical implement 132 is shown inserted into the inlet 20 of the injection port 15. Due to the relative geometries of the Luer connection, the tip 134 extends into the lumen 150 a known amount or distance that can readily be sized and computed.
  • the distal end of the Luer tip 134 is spaced from the port valve 51 for the given injection port height. Fluids stored within the male medical implement 132 can now be injected through the lumen 150 of the injection port 15, the interior cavity 13 of the catheter hub 10, and the catheter tube 40 to the patient. When fluids are discharged from the medical implement 132, fluid pressure generated presses on the exterior wall of the port valve 51 and collapses the port valve 51, thereby breaking the seal between the lumen 150 and the interior cavity 13 so that fluid can pass to the patient through the catheter tube 40.
  • a valve opener can be disposed inside the lumen 150 of the injection port 15, between the distal end of the tip 134 and the valve 50.
  • the valve opener can be sized and shaped to advance against the valve 50 by the pressing action of the distal end of the tip 134 of the male medical implement to press against the wall surface of the port valve 51 to collapse the port valve 51 and open the fluid pathway between the injection port and the interior bore of the catheter hub.
  • the valve opener may be used to advance against and physically deform the port valve 51 to break the seal and allow fluid to pass from the male medical implement 132 into the patient via the injection port 15.
  • a vacuum can be applied or generated at the lumen 150 of the injection port 15 while still maintaining the port valve 51 in the collapsed state, such as to take sample or draw in fluid into the male medical implement 132.
  • An exemplary valve opener can be generally elongated with a surface for contacting by the tip 134 of the male medical implement 132 and has a surface that can press against the valve 50 to collapse the valve 50.
  • One or more fluid pathways are provided with the valve opener for fluid flow across the valve opener.
  • an aspect of the present disclosure is understood to include a ported catheter assembly 100 wherein fluids can be injected or aspirated through the injection port 15 of the catheter body 11.
  • the present disclosure is further understood to include an integrated valve 50 comprising a port valve 51 and an inlet valve 49.
  • fluids are aspirated through the injection port 15 by first collapsing the port valve 51 located in the catheter body 11 through physical means or a physical object.
  • a valve opener may be located inside the injection port and advanced against the port valve 51 by a medical implement 132 to collapse the port valve 51. Once the valve 50 is collapsed by a physical object rather than fluid pressure, the seal at the injection port 15 is broken and fluids can be injected or aspirated through the injection port 15.
  • fluid samples may be drawn through, such as aspirated through, the injection port 15 and into the medical implement, such as a syringe.
  • the length of the injection port 15 can be reduced to enable the tip of the male medical implement 132 to physically deform the port valve 51 , without a valve opener.
  • the port valve 51 elastically returns back to its original shape thereby restoring the seal between the lumen 150 of the injection port 15 and the interior cavity 13 of the catheter body 11.
  • the valve opener and the interior bore of the injection port can also be configured so that a resilient component of the valve opener presses against the interior bore to move away from the valve as the physical constraint is removed.
  • the lumen 150 of the injection port 15 is no longer in fluid communication with the interior cavity 13 of the catheter body 11 due to the seal now formed by the expanded port valve 51.
  • aspects of the present disclosure include a port valve 51 of a valve 50 that elastically springs back to its original cylindrical shape and a valve opener to move away from the port valve 51 once physical constraint is removed at the inlet of the injection port. It is understood that if the injection port 15 has a shortened height, then the tip 134 of the medical implement 132 can physically collapse the port valve 51 without the need for a valve opener.
  • an aspect of the present disclosure is a ported catheter in which the injection port is shortened so that when a tip 134 of a male medical implement 132 is inserted into the shortened port, the tip 134 presses and physically deforms the port valve 51 to open the port for fluid flow, for either an injection or aspiration through the injection port 15.
  • the valve 50 is further understood to include an inlet valve 49.
  • the inlet valve 49 can have one or more slits and tapered surfaces.
  • FIG. 7C shows the valve 50 in a collapsed state without the catheter hub 10.
  • the valve 50 is collapsed at or near the open distal end 34 of the cylindrical body 36, such as due to fluid pressure, due to a part or portion of a valve opener pressing against the cylindrical body 36 to collapse the cylindrical body 36, or due to the tip 134 of a male medical implement 132 pressing against the cylindrical body 36 to collapse the cylindrical body 36.
  • FIG. 8 a top cross-sectional view of the catheter assembly is shown with the port valve 51 in a collapsed or open position, which shows the flow path 130 between the lumen 150 of the injection port 15 and the interior cavity 13 of the catheter hub 10 opened for fluid flow.
  • the opening 54 of the split septum 53 of the inlet valve 49 is shown in a closed state. Fluid back pressure pushes the split septum 53 towards the proximal end 12 of the catheter body 11, against the tapered conical wall surface 114. Because of the conical shape contour of the split septum 53, the pressure further compresses the opening 54 of the split septum 53 to form a tighter seal or seals along one or more seams. Back flow of fluid can come from fluid injection delivery through the injection port 15 and/or back pressure from venous pressure from the patient through the catheter tube 40.
  • FIGS. 9A-9C the catheter assembly of FIGS. 1-4 are shown in a flow state through the rear valve or inlet valve 49.
  • FIG. 9A shows a male medical implement 140 connected to a proximal end 12 of the catheter body 11.
  • FIG. 9B shows the valve 50 without the catheter hub with the inlet valve 49 in an open state.
  • FIG. 9C is a close-up view of the circled portion 9C of FIG. 9 A.
  • a male Luer lock 142 of a male medical implement 140 is attached to the proximal end 12 of the catheter body 11.
  • the proximal end 12 of the catheter body 11 is sized and shaped to accommodate a Luer tip 134/145 of the medical implement 140, which is shown with a threaded collar 142 for engaging external threads at the outer surface of the catheter body 11 , surrounding the inlet of the catheter body 11 at the proximal end 12.
  • the tip 134/145 of the male Luer lock is shown inserted into the proximal end 12 of the catheter body 11 and due to the relative geometries of the Luer fit between the two, the tip 134/145 extends into the interior cavity 13 of the catheter body 11 a known amount or distance that can readily be sized and computed. As shown in FIG.
  • the distal end of the male Luer tip 134/145 is pressed against the end surface 122 of the septum ring 57, which pushes the split septum 53 distally.
  • an axially extending force applied in the distal direction on the septum ring 57 will cause the second conical section 402 to move distally closer to the first conical section 400.
  • the second conical section 402 moves, such as partially or completely, into the shaped gap 120 provided between the first and second conical sections 400, 402.
  • the opening 54 at the apex 112 is expanded, thereby breaking the seal to allow fluids stored within the male medical implement 140 to flow through the opening 54, through the open bore of the port valve 51, through the interior cavity 13 of the catheter body 11, and through the catheter tube 40 to the patient.
  • the opening 54 expands due at least in part to the first conical section 400 being pushed distally by the second conical section 402 but since the web 118 of the first conical section 400 is held by the cylindrical body 36, the web 118 mostly expands radially outwardly away from the lengthwise axis of the valve 50 to cause the seam of the split septum 53 to open the opening 54.
  • the port valve 51 at the distal end 34 of the valve 50 does not move distally when the valve 50 is pressed by the male medical implement 140 at the proximal end 38 because of the step 16 formed in the interior cavity 13 of the catheter hub 10 preventing the securing ring 60 attached to the valve 50 from moving distally, as shown in FIG. 9C.
  • This ensures only the split septum 53 is pressed distally when the second conical section 402 moves against the first conical section 400 to expand the opening 54 without moving the entire valve 50.
  • a pressed fit arrangement between the securing ring 60 and the interior surface of catheter hub is sufficient to retain the valve 50 in place when the inlet valve 49 is actuated by a medical implement 140.
  • valve body can be pressed fit into the bore of the catheter hub 10 without a securing ring 60.
  • tapered geometries, shoulders, or stepped surfaces between the catheter hub 10 and the valve 50 may be employed to secure the valve 50 without a separate securing ring 60.
  • the elasticity of the valve 50 will allow the web 118 and the wall 114 of the first and second conical sections 400, 402 to elastically return from their deflected positions shown in FIGs. 9B and 9C to their un-deflected position or closed position shown in FIGs. 5A and 6 to close the split septum 53 and close the fluid pathway between the interior cavity 13 of the catheter hub body 11 and the proximal inlet.
  • FIG. 10 illustrates another embodiment of a valve 70 that is usable with the ported catheter assembly 100 of FIGS. 1 and 2.
  • the valve 70 includes a port valve 71 and an inlet valve 89 comprising a split septum 73 located proximal of the port valve 71.
  • the inlet valve 89 seals the bore 110 (FIG. 11) from the proximal end 12 and the port valve 71 seals the lumen 150 of the injection port 15 from the interior cavity 13 of the catheter body 11.
  • the valve 70 of the present embodiment is substantially similar to the valve 50 of FIG. 4 with a few exceptions.
  • the present split septum 73 has a slit that defines an opening 74 which opens when pressed against in a distal direction by a male medical implement 140.
  • two or more slits are provided to define the opening 74.
  • two slits in the form of a plus "+” may be incorporated at the tip 146, or three slits spaced 120 degrees apart forming a "Y" like pattern.
  • the port valve 71 is functionally similar to the port valve 51 of the valve 50 of FIG. 4 and can be actuated to open by fluid pressure, by a tip of a male medical implement 132, or by a valve actuator.
  • the valve 70 has a proximal tip or head 146 comprising a septum ring 77. As shown, the tip 146 resembles a mushroom head comprising a semi-spherical dome.
  • the port valve 71 is connected to the inlet valve 89 by an elastic neck or neck section 72.
  • the elastic neck 72 is hollow and has an inside diameter that is generally constant while having an outside diameter that varies along the length of the elastic neck, thus creating a variable wall thickness along at least a portion of the length of the elastic neck 72.
  • the outside diameter can be constant while the interior diameter can vary to form a variable wall thickness along the length of the neck section.
  • variable wall thickness can extend the entire length the neck section 72
  • a generally constant wall thickness section 148 is incorporated with the present embodiment at the connection point with the tip 146.
  • the variable wall thickness of the neck section 72 defines a collapsible region that compresses when the tip 146 is pressed by a male medical implement 140 to open the split septum 73.
  • only the elastic neck 72 and possibly the tip 146 collapse when pushed by a male medical implement 140 to open the inlet valve 89.
  • only the collapsible region of the elastic neck 72 collapses.
  • the constant thickness section 148 also collapses when axially loaded.
  • the present embodiment is understood to include a tip having an arc surface that is distorted and/or flattened when pressed by a male medical implement to open the inlet valve 89.
  • the tip having the arc surface can be relatively more rigid and not distort of flattened when pressed by a male medical implement.
  • the cylindrical body 36 with the port valve 71 should be stiff er than the elastic neck 72 to allow the elastic neck 72 to elastically deform towards the port valve 71.
  • the securing ring 60 will fix sections of the valve 70 distal of the securing ring 60 from moving and/or collapsing in the axial direction due to the distally directed force of a male medical implement 140 acting on the inlet valve 89.
  • the entire valve 70 can alternatively have the same or somewhat similar stiffness and the neck section 72 and can still compress by a male medical implement 140 to open the inlet valve 89 while the port valve 71 is held steady and uncompressed by a securing ring 60.
  • the opening 74 can be a hole or one or more slits communicating with the open bore 110 of the port valve 71.
  • the opening 74 of the split septum 73 Prior to activation, the opening 74 of the split septum 73 is sealed against itself or is sealed around a needle passing therethrough in a ready position for venipuncture.
  • the seam or seams defining the opening 74 may be formed in a post-mold operation, such as by cutting.
  • the outside diameter of the septum ring 77 is larger than the interior bore of the catheter hub 10 and is squeezed by the interior bore of the catheter hub 10 to assist in closing the opening 74 of the inlet valve 89.
  • FIG. 11 shows a securing ring 60 placed around the valve 70 for securing the valve 50 inside the interior bore of the catheter body 10.
  • the securing ring 60 is similar to the securing ring 60 of FIG. 5 A for securing the valve 70 to the interior cavity 13 of the catheter body 11.
  • the inwardly extending lip 61 of the securing ring 60 engages a notch 78 in the outer surface of the cylindrical body 36 to couple and secure the valve 70 to the interior cavity 13 of the catheter body 11.
  • a step 60a formed on an exterior surface of the securing ring 60 can abut a step formed in the interior cavity 13 of the catheter body 11 to prevent the securing ring 60 and hence the valve 50 attached to the securing ring 60 from axial movement, excluding when the valve 50 is compressed to be opened by a medical implement or by pressure, a male Luer tip, or a valve opener to open the valve.
  • valve 70 of FIGS. 10 and 11 is shown positioned in an interior cavity of a catheter hub 11.
  • the port valve 71 seals off the interface between the lumen 150 of the injection port 15 and the interior cavity 13 of the catheter body 11 by forming a seal to prevent fluid from entering the interior cavity 13 from the injection port 15, and also prevents fluid from passing through the injection port 15 from the interior cavity 13.
  • the port valve 71 has a shape matching a shape of the interior cavity 13 of the catheter body 11, but can be sized slightly larger, such as a larger diameter, than the interior cavity 13 to provide a tight fit inside the interior cavity 13.
  • the catheter hub 10 of FIG. 12 is shown in a used position in which a male medical implement 140 is attached to the proximal end 14 of the catheter body 11.
  • the proximal end 14 of the catheter body 11 is sized and shaped to accommodate a Luer tip with or without a threaded collar for engaging external threads at the outer surface of the catheter body 11 surrounding the inlet of the catheter body 11 at the proximal end 14.
  • the tip 134 of the male Luer lock is shown inserted into the inlet of the catheter body 11 and due to the relative geometries of the Luer connection, extends into the interior cavity 13 of the catheter body 11 a known amount or distance that can readily be determined.
  • an aspect of the present disclosure is understood to include a valve 50 comprising a tip 146 attached to an elastic neck 72, which is attached to a cylindrical body 36.
  • the cylindrical body 36 further comprises a port valve 71 for closing a flow space between an injection port 15 and the interior cavity 13 of the catheter hub 10.
  • the tip and the neck of the inlet valve deform to open a slit located on the tip, which opens to permit fluid flow through the valve 50.
  • the tip 146 comprises a semi-spherical dome surface resembling a mushroom head and having a slit formed therein or thereon and completely through the wall surface of the dome.
  • the slit may have a simple straight line or a complex line, such as a plus "+" configuration.
  • a securing ring 60 is used to secure the valve 50 inside the bore of a catheter hub 10.
  • the securing ring 60 can be omitted and the valve 50 is pressed fit into the bore without the securing ring 60, as previously described with other valve embodiments.
  • the elasticity of the valve 50 allows the elastic neck 72 and the tip 146 to recoil or expand from their collapsed position, as shown in FIG. 14 outside of a catheter hub 10, back to their expanded or closed position, as shown in FIG. 10, to close the fluid pathway through the inlet of the catheter hub 10.
  • valve 80 that is useable with a ported catheter assembly 100 is shown.
  • the present valve 80 embodiment includes a port valve 81 and an inlet valve 99 with a split septum 83, similar to other valve embodiments discussed elsewhere herein with a few exceptions.
  • the inlet valve 99 is positioned proximally of the port valve 81 and has an opening 84, a tapered wall 86 connected to a web 144.
  • the web 144 and the tapered wall 86 define surface features of the split septum 83, which has an apex 112 projecting in the distal direction towards the port valve 81.
  • the present valve 80 embodiment is substantially similar to the valve 50 of FIG. 4 and related figures with a few exceptions.
  • a recess or notch 82 is provided with the septum ring 87 and a groove 85 (FIG. 16) is provided between the tapered wall 86 and the septum ring 87.
  • the groove 85 may have a "V- shape" cross-section or a "U-shaped” cross-section with straight or tapered sidewalls for retaining a hook of a needle guard 90, as further discussed below.
  • the valve 80 can include one or more recesses 82 and one or more grooves 85. The valve 80 may be useable with any of the ported catheter hubs described elsewhere herein.
  • An optional securing ring 60 may be used with the present valve 80 to secure the valve
  • an inwardly extending lip 61 of the securing ring 60 can engage a notch 88 formed in the outer surface of the cylindrical body 36 to couple and secure the valve 80 to the interior cavity 13 of the catheter body 11.
  • the port valve 81 has an open bore 110 that permits fluid communication with the split septum 83.
  • valve 80 is shown positioned inside a bore of a ported catheter 11.
  • the port valve 81 of the valve 80 seals off the interface between the lumen 150 of the injection port 15 and the interior cavity 13 of the catheter body 11 by forming a seal to prevent fluid from entering the interior cavity 13 from the injection port 15, and also prevents fluid from passing through the injection port 15 from the interior cavity 13.
  • the port valve 81 has a shape matching a shape of the interior cavity 13 of the catheter body 11, but can be sized slightly larger, such as a larger diameter, than the interior cavity 13 to provide a tight fit inside the interior cavity 13.
  • a shroud 101 on a needle hub 105 is shown attached to the proximal end of the catheter hub 10. More particularly, the proximal end of the catheter hub 11 projects into an open space defined by the shroud 101 of the needle hub 105.
  • the two hubs can connect or engage through a plurality of deflectable fingers 160 with projections 162 fitting against recess sections formed with the catheter hub 11.
  • Other engagement means are contemplated for removably securing the needle hub 105 to the catheter hub 10 in a ready to use position, such as using projections only without recesses, using a coupler as a separate component to secure to the needle hub 105 and the catheter hub 10 together.
  • the coupler can separate from the catheter hub 10 or the needle hub 105 and remain with the other one of the catheter hub
  • the needle 106 extends from a nose section 164 of the needle hub 105 and passes through a safety clip or needle guard 90, the valve 80, the catheter hub 11, and the catheter tube 40 with the sharp distal tip of the needle extending out a distal end of the catheter tube 40 in a ready to use position.
  • 11 has a female Luer connector with external threads to engage one or more projections formed with the shroud 101 of the needle hub 105.
  • the needle guard 90 has a proximal wall 91, a perimeter defining an opening 95 through the proximal wall 91, and two arms 92 extending distally of the proximal wall 91 and engaging the valve 80.
  • Each of the two arms 92 comprises a distal wall 166 having a curved lip or hook 94 at an end thereof, which in the embodiment shown is a free end 93 and is not connected to or attached to any other structure.
  • the arms 92 have different lengths so that when the needle guard 90 is activated, the two distal walls 166 are axially offset, as shown in FIG. 19. In the embodiment shown, one of the free ends 93 contacts the valve 80 while the other free end 93 contacts the needle shaft in the ready position.
  • one of the free ends 93 of one of the arms 92 extend through the recess 82 of the septum ring 87 so that the hook 94 of that arm interacts with the groove 85 located between the septum ring 87 and the tapered wall 86.
  • the hook 94 can contact the groove 85 at a location of the groove 85 distal the recess 82 on the septum ring 87.
  • the groove 85 can thus hold at least one of the arms 92 spaced apart from the needle 106 thereby holding the needle guard 90 in place until the needle 106 is retracted proximally from the catheter hub 10.
  • the elastic material of the tapered wall 86 is compressed or squeezed due to the presence of the needle through the valve, which helps prevent the hook 94 from dislodging from the groove 85. Furthermore, because the tapered wall 86 is pressed outwardly, the arm 92 having the hook 94 in the groove, is also pressed outwardly which leaves less gap between the arm 92 and the interior cavity wall of the catheter body 11 thereby restricting the amount of movement of the arm 92 outwardly and reduce or eliminate the possibility of the hook 94 dislodging from the groove 85.
  • the inlet valve 99 can be modified to support both arms so that both arms are spaced from the needle in a ready to use position.
  • the inlet valve 99 can be extended and provided with two grooves 85 and two recesses 92 on the septum ring 87 to support both free ends 93 of the needle guard 90. Both arms 92 can then be held apart from the needle 106 to reduce friction to the needle 106 as the needle 106 retracts proximally following successful venipuncture.
  • one or both free ends 93 of the two arms 92 have a simple straight edge without the curved lip or hook 94.
  • the two arms 92 are each shown with folded tabs 168, such as two or more folded tabs on each distal wall, to reinforce the two distal ends and prevent the needle from moving laterally outside the arms 92.
  • the needle guard 90 is partially located within the interior cavity 13 of the catheter hub 10 with portions of the needle guard 90 located exteriorly of the catheter hub 10. As shown, the portions of the needle guard 90 that are outside of the catheter hub 10 are wholly or partially covered by the shroud 101.
  • the opening 84 of the split septum 83 closes, thereby sealing a fluid pathway through the valve 80.
  • the shroud 101 of the needle hub 105 separates from the catheter hub 10 when the needle 106 and needle hub 105 are retracted proximally.
  • the change in profile 107 such as a bulge or a crimp
  • the change in profile 107 is too large to pass through the opening 95 and pulls on the needle guard 90 in the proximal direction to separate the needle guard 90 from the valve 80.
  • the hook 94 of one of the arms 92 is pulled out from the groove 85 and passes through the recess 82 on the septum ring 87 during the retraction process.
  • the arm 92 without the hook 94 engaged in the groove 85 will begin to close over the tip of the needle 106 and the hook 94 engaged in the groove 85 can be pulled out proximally more readily because the tapered wall 86 on the valve is no longer compressed. Furthermore, because the tapered wall 86 is no longer pressed outwardly, the arm 92 having the hook 94 in the groove, is no longer pressed outwardly which leaves more gap between the arm 92 and the interior cavity wall of the catheter body 11 to dislodge the hook 94 from the groove 85.
  • FIG. 19 shows the change in profile 107 of the needle 106, such as a crimp, a bulge, a material build up, or a sleeve mounted on the needle, engaging the proximal wall 91 of the needle guard 90, such as the perimeter defining the proximal opening on the proximal wall, as the needle 106 is retracted proximally.
  • the change in profile 107 shown is a crimp, which has a section that is enlarged and a section that is depressed or squeezed, and the view shown is along the depressed section of the crimp.
  • a male medical connector such as an IV connection, can be coupled directly or indirectly to the proximal end 12 of the catheter hub 10 to infuse fluids into the patient.
  • ported catheter assemblies and their components have been specifically described and illustrated herein, many modifications and variations will be apparent to those skilled in the art. Furthermore, elements and features expressly discussed for one embodiment but not for another may equally apply provided the functionality or structures do not conflict. Thus, unless the context indicates otherwise, like features for one embodiment are applicable to another embodiment. Accordingly, it is to be understood that the ported catheter assemblies and their components constructed according to principles of the disclosed devices, systems, and methods may be embodied other than as specifically described herein. The disclosure is also defined in the following claims.
EP16709373.1A 2015-03-10 2016-03-09 Katheteranordnungen mit durchflussregelventilmechanismen und zugehörige verfahren Withdrawn EP3268076A1 (de)

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US201562131026P 2015-03-10 2015-03-10
PCT/EP2016/054992 WO2016142410A1 (en) 2015-03-10 2016-03-09 Catheter assemblies with flow control valve mechanisms and related methods

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CN (1) CN107635618A (de)
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US20200121896A1 (en) * 2018-03-05 2020-04-23 Poly Medicure Limited Intravenous catheter assembly
US11324927B2 (en) 2019-05-29 2022-05-10 Becton, Dickinson And Company Catheter assembly having an injection port and related methods
US20230248947A1 (en) * 2020-07-07 2023-08-10 Vigmed Ab Catheter instrument
WO2022172281A1 (en) * 2021-02-10 2022-08-18 Neeraj Gupta Intravenous cannula
WO2024008868A2 (en) * 2022-07-06 2024-01-11 B. Braun Melsungen Ag Catheter devices with valves and related methods

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US5098405A (en) * 1991-01-31 1992-03-24 Becton, Dickinson And Company Apparatus and method for a side port cathether adapter with a one piece integral combination valve
US6171287B1 (en) * 1998-05-29 2001-01-09 Lawrence A. Lynn Luer receiver and method for fluid transfer
US5810768A (en) * 1995-06-07 1998-09-22 Icu Medical, Inc. Medical connector
CN2274969Y (zh) * 1996-11-15 1998-02-25 郑开泰 心内手术体外循环安全压力阀
US6117108A (en) * 1997-08-20 2000-09-12 Braun Melsungen Ag Spring clip safety IV catheter
US7163525B2 (en) * 2004-12-17 2007-01-16 Ethicon Endo-Surgery, Inc. Duckbill seal protector
JP2007143813A (ja) * 2005-11-28 2007-06-14 Nippon Sherwood Medical Industries Ltd 医療用活栓
DE202007006190U1 (de) * 2006-07-31 2007-08-23 B. Braun Melsungen Ag Kathetervorrichtung
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US9155876B2 (en) * 2011-10-06 2015-10-13 Becton, Dickinson And Company Port valve of a blood control catheter

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RU2017135545A (ru) 2019-04-10
WO2016142410A1 (en) 2016-09-15
CN107635618A (zh) 2018-01-26
SG10201908316RA (en) 2019-10-30
SG11201705951TA (en) 2017-09-28
HK1245686A1 (zh) 2018-08-31
RU2017135545A3 (de) 2019-08-14

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