RU2812002C2 - Intravenous catheter assembly and method of its production - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: group of inventions relates to a needle-covering catheter assembly, activated, for example, by a Luer device, and to a method of producing such a catheter; more specifically, the invention relates to an intravenous catheter assembly and a method of its production. Intravenous catheter assembly (100) contains a catheter tube (104), a needle, valve (120), a skirt section (250), and a valve drive (122). The catheter tube (104) contains a cavity, an opening at the distal end, and a proximal end connected to the distal end of the catheter hub (102). The catheter sleeve (102) contains a catheter body with an outer surface and an inner surface defining an internal cavity containing at least one collar (173). The needle includes a needle tip at a distal end and a proximal end attached to a needle hub. The needle passes through the catheter hub (102) and through the catheter tube (104) and includes a needle tip protruding distally from an opening at the distal end in a ready-to-use position. The valve (120) contains a valve disc located in the internal cavity of the catheter sleeve (102). The valve disk includes at least one slot and at least two flaps (194), a proximally facing surface and a distally facing surface. The distally facing surface is in contact with at least one shoulder (173). The skirt portion (250) extending from the valve disk includes a wall with an outer surface and an inner surface defining the interior of the skirt, and a proximal end surface (290) of the skirt. The skirt portion (250) is in contact with the inner surface of the catheter sleeve (102). The valve drive (122) is located in the internal cavity of the catheter sleeve (102). The valve actuator (122) has a nose portion (150) at a distal end and a proximal portion located proximal to the nose portion (150). The nose portion (150) includes an opening for fluid flow and a drive end (180) at the most distal end of the nose portion (150), and the proximal portion has at least one gap for fluid flow through or through it. The valve actuator (122) is located in a proximal position in the internal cavity and is configured to slide to a distal position in the internal cavity when pressed by a medical instrument (200). The nose part (150) is located at least partially in the inner part of the skirt in a position ready for use. Two spaced apart thrust surfaces (295, 298) are located proximally from the drive end (180) of the valve actuator (122) and proximally from the proximal end surface (290) of the skirt in a ready-to-use position. The thrust surfaces (295, 298) are sized and shaped to abut the proximal end surface (290) of the skirt when the valve actuator (122) is in the distal position. The skirt portion (250) provides an axially directed force acting on the valve actuator (122) when stored energy is released onto the adjacent surfaces (295, 298) of the valve actuator (122) to return it to the proximal position. A method of production of an intravenous catheter assembly (100) comprises fastening the above described catheter tube (104), fastening the above described needle (108), placement of the above-described valve (120), extension of the above-described skirt section (250) from the valve disk (121), placement of the valve actuator (122) in the internal cavity (123) of the catheter sleeve (102).

EFFECT: obtaining an intravenous catheter assembly and a method of its production.

15 cl, 48 dwg

Description

TECHNICAL FIELD

The present invention generally relates to a needle-enclosing catheter assembly, activated by, for example, a Luer device, and a method for producing such a catheter, more particularly, the present invention relates to an intravenous catheter assembly and a method for producing the same.

BACKGROUND OF THE ART

The procedure for inserting an intravenous (IV) catheter assembly involves four main steps: (1) the healthcare professional inserts the needle and catheter together into the patient's vein; (2) after the needle tip is inserted into the vein, the catheter is advanced into the patient's vein when the health care professional pushes the catheter with a finger; (3) the healthcare professional removes the needle by grasping the end of the hub (opposite the tip end) while applying pressure to the patient's skin at the insertion site with his free hand to stop the flow of blood through the catheter; and (4) the healthcare professional then adheres the open end of the catheter (catheter hub) to the patient's skin and connects it to a source of fluid to be injected into the patient's vein.

One problem is that immediately after removing a needle from a patient's vein, a health care provider, who is busy with at least two emergency procedures at the time, must place the exposed tip of the needle in an adjacent location and perform the tasks necessary to remove the needle. It is at this point that the exposed needle tip creates the risk of accidental needlestick injury, which in these circumstances leaves the healthcare worker vulnerable to the transmission of a variety of dangerous blood-borne pathogens, including AIDS and hepatitis.

Another challenge is applying finger pressure in the correct position to stop the flow of blood through the catheter once the needle is removed. This itself creates a risk of needle stick injury if the physician's elbow accidentally hits the needle while removing it or if the physician attempts to reinsert the needle into the catheter while applying finger pressure.

Sometimes these needle-enclosing catheter assemblies are used for high-pressure injections for diagnostic purposes in the radiology department of a hospital. These assemblies must withstand pressures of three (3) bars or more. This involves holding the septum in place so that it can be opened and closed repeatedly even after such high pressure is applied.

SUMMARY OF THE INVENTION

Disclosed are needle devices having a component that secures the valve in the hub of a standard diameter Luer cone catheter. The locking component may be referred to as a locking device and may provide a proximally directed axial force to return the valve actuator from a distal position to a proximal position when the Luer cone is released from the catheter hub. Various components may be located within the one-piece catheter hub body. The various components may include a component that restricts fluid flow, provides actuation to ensure fluid flow, prevents needlestick injuries, and combinations thereof.

The locking device may include a structure whose surface defines a channel and in which at least a portion of the valve actuator is located in the channel. The valve actuator part located in the channel of the locking device can be located either in a ready-to-use position or in an activated position.

The locking device may hold the valve in the interior of the catheter hub. The valve may be a valve disc. In addition to locking the valve, the locking device may be configured to apply a proximally directed force to return a valve actuator that has advanced distally to open one or more valve leaflets from a distal position to a proximal position.

The retaining device may include one or more leaf springs, which may itself be a coil spring such as a conical coil spring, may be an O-ring, or may apply a force to the compliant portion or parts of the valve actuator such that the compliant portion or parts provide a proximally directed force to move the valve actuator from a distal position to a proximal position.

The fixation device may have a body with an outer surface, an inner surface, a proximal end and a distal end.

Objects of the invention are a catheter assembly including a catheter tube containing a cavity, a distal end opening and a proximal end attached to a catheter hub, wherein said catheter hub includes a catheter body with an outer surface and an inner surface defining an inner cavity having at least one collar ; a needle comprising a needle tip at a distal end and a proximal end attached to a needle hub, said needle extending through the catheter hub and through the catheter tubing, and wherein the needle tip protrudes from the distal end hole in a ready-to-use position; a valve comprising a valve body including at least one slot, a proximally facing surface and a distally facing surface located in an internal cavity of the catheter hub; a valve actuator located in the internal cavity of the catheter hub, wherein said valve actuator has a nose portion with a channel and a proximal portion with at least one gap for fluid flow passing through or over it, and is configured to slide between a proximal position and a distal position position in the internal cavity when it is pushed by the Luer cone; a locking device contacting or integrated with the valve on a proximally facing surface of the valve body for retaining the valve within an internal cavity of the catheter hub, said locking device including a lock body having an inner surface containing a channel defining a fluid path, a distal end and a proximal end end; and a needle guard mechanism having a protective surface located lateral to the needle in a ready-to-use position and extending to a position distal to the needle tip in a protected position to cover the needle tip from accidental needle stick.

The distal end of the retainer body may have an internal diameter (ID) of a first size and the proximal end a second size ID that is smaller than the first size.

The retaining device may be a holder, a retaining ring, a retaining skirt, an O-ring, or a conical coil spring.

Another object of the invention is a catheter assembly, including: a catheter tube containing a cavity, a distal end opening and a proximal end connected to a catheter hub, wherein said catheter hub includes a catheter body with an outer surface and an inner surface defining an internal cavity having at least one shoulder; a needle having a needle tip at a distal end and a proximal end attached to a needle hub, said needle extending through the catheter hub and through the catheter tubing, and wherein the needle tip protrudes from the distal end hole in a ready-to-use position; a valve comprising a valve body including at least one slot, a proximally facing surface and a distally facing surface located in an internal cavity of the catheter hub; a valve actuator located in an internal cavity of the catheter hub, wherein said valve actuator has a nose portion with a channel and a proximal portion with at least one gap for fluid flow passing through or over it, and is movable between a proximal position and a distal position within internal cavity when pushed with a medical instrument; a locking device including a holder body having an internal surface containing a channel defining a fluid path, a distal end and a proximal end, wherein said distal end of the holder body contacts or is integrated into the valve on a proximally facing surface of the valve body to retain the valve in the internal cavity of the catheter sleeve, and the specified proximal end of the holder body is located distally from at least one shoulder of the catheter body and is limited by at least one shoulder from displacement in the proximal direction, or the specified locking device is engaged with the catheter sleeve to retain the valve in the internal cavity of the sleeve catheter; and a needle guard mechanism comprising a protective surface located lateral to the needle in a ready-to-use position and extending to a position distal to the tip of the needle in a protected position to cover the tip of the needle from inadvertent puncture.

The valve actuator nose may have a continuous surface in the radial direction. The nose may have a cut or gap so that the body is not continuous all the way around. The proximal portion may be located proximal to the nasal portion. The proximal portion of the valve actuator may have a clearance or passage for fluid. The proximal portion may have two plunger elements spaced apart from each other.

Another object of the invention is a catheter assembly, including: a catheter tube containing a cavity, a distal end opening and a proximal end attached to the distal end of a catheter hub, wherein said catheter hub includes a catheter body with an outer surface and an inner surface defining an internal cavity having at least one collar; a needle having a needle tip at a distal end and a proximal end attached to a needle hub; wherein said needle passes through the catheter hub and through the catheter tube, and wherein the tip of the needle protrudes from the distal end hole in a ready-to-use position; a valve having a disk-shaped valve body, the disk-shaped valve body including at least one slot and at least two leaflets, a proximally facing surface and a distal facing surface located in an internal cavity of the catheter hub; a valve actuator located in an internal cavity of the catheter hub, wherein said valve actuator has a nose portion with a channel and a proximal portion with at least one gap for fluid flow passing through or over it, and is movable between a proximal position and a distal position within internal cavity when pushed with a medical instrument; a locking device including a metal lock body having a fluid passage, a distal end, and a proximal end, wherein said distal end of the lock body is in contact with a proximally facing surface of a disk-shaped valve body for retaining the valve between a distal end of the catheter hub and the locking device during the internal cavity of the catheter sleeve; and a needle protection mechanism comprising a protective surface located lateral to the needle in a ready-to-use position and configured to move to a position distal to the tip of the needle in a protected position to cover the tip of the needle from inadvertent puncture.

The valve actuator nose portion may be a contoured nose portion having surfaces for compressing at least two leaflets against the interior of the catheter hub or at least for deflecting the valve leaflets distally, as well as for axially pressing the valve against the collar of the catheter hub.

More generally, the nose portion of a valve actuator disclosed herein can deform the valve to transfer stored energy to the valve. The valve actuator nose portion disclosed herein may deflect the valve or bias the valve to transfer stored energy to the valve.

Another object of the invention is a catheter assembly, including: a catheter tube containing a cavity, a distal end opening and a proximal end attached to a catheter hub, wherein said catheter hub includes a catheter body with an outer surface and an inner surface defining an internal cavity having at least at least one collar; a needle having a needle tip at a distal end and a proximal end attached to a needle hub, said needle extending through the catheter hub and through the catheter tubing, and wherein the needle tip protrudes from the distal end hole in a ready-to-use position; a valve comprising a valve body including at least one slot, a proximally facing surface and a distally facing surface located in an internal cavity of the catheter hub; a valve actuator located in the internal cavity of the catheter hub, wherein said valve actuator has a distal nose portion with a channel and a proximal portion with at least one gap for the flow of fluid through or over it and configured to move between a proximal position and a distal position in the internal cavity when it is pushed by the luer cone tip of the medical instrument; and a conical coil spring including a plurality of coils disposed on the proximally facing surface of the valve and configured to be compressed by the valve actuator when the valve actuator is pushed into a distal position by the tip of the luer cone, and expanded to return the valve actuator to the proximal position.

The catheter assembly may include a needle protection mechanism comprising a protective surface located lateral to the needle in a ready-to-use position and configured to move to a position distal to the tip of the needle in a protective position to protect the tip of the needle from accidental puncture.

Another object of the invention is a catheter assembly, including: a catheter tube containing a cavity, a distal end opening and a proximal end attached to a catheter hub, wherein said catheter hub includes a catheter body with an outer surface and an inner surface defining an internal cavity having at least one shoulder; a needle having a needle tip at a distal end and a proximal end attached to a needle hub, said needle extending through the catheter hub and through the catheter tubing, and wherein the needle tip protrudes from the distal end hole in a ready-to-use position; a valve comprising a valve body including at least one slot, a proximally facing surface and a distally facing surface located in an internal cavity of the catheter hub; a valve actuator located in an internal cavity of the catheter hub, wherein said valve actuator has a distal nose portion with a channel and a proximal portion with at least one gap for fluid to pass through or over it and configured to slide between a proximal position and a distal position in internal cavity when pressed with a medical instrument; and a retaining skirt portion formed with the valve, wherein said retaining skirt portion has an outer surface directly facing the inner surface of the catheter hub and an inner surface directly facing the nose portion of the valve actuator, wherein the retaining skirt portion is sized and shaped to compression between the inner surface of the catheter hub and the nose of the valve actuator when the valve actuator is pushed into a distal position by the luer cone tip of the medical instrument, and expansion to return the valve actuator to the proximal position when the luer cone tip of the medical instrument is disconnected.

The skirt portion is sized and shaped to deform or move under the action of the valve actuator nose when the valve actuator is pushed into a distal position by the tip of the Luer cone of the medical instrument, and to expand to return the valve actuator to the proximal position when the tip of the Luer cone of the medical instrument is disconnected. The skirt portion is configured in size and shape to vary from a first size of the valve actuator nose when the valve actuator is pushed into a distal position by the luer cone tip of the medical instrument, to a second size that is smaller than the first size, and the skirt portion is configured to expand to return driving the valve to the proximal position when the luer cone tip of the medical instrument is disconnected. The resizable size can be any size of the skirt part that is being physically transformed.

The valve disk may have two or more valve leaflets, such as three valve leaflets that are sized and shaped to be deformed, displaced, or deflected by the nose of the valve actuator when the valve actuator is pushed into a distal position by the tip of a medical instrument's luer cone, and two or more the valve flaps are configured to expand or extend to return the valve actuator to a proximal position when the luer cone tip of the medical instrument is disconnected. The valve flaps are sized and shaped to change from a first size under the action of the nose of the valve actuator when the valve actuator is pushed into a distal position by the luer cone of the medical instrument, to a second size that is smaller than the first size, and the valve flaps are configured to expand to return actuating the valve to the proximal position when the luer cone of the medical instrument is disconnected. The changing size can be any dimension of the valve leaflet dimension allowed by the physical transformation, for example, straight lines become curved and acquire a smaller longitudinal profile.

Another object of the invention is a catheter assembly, including: a catheter tube containing a cavity, a distal end opening and a proximal end attached to a catheter hub, wherein said catheter hub includes a catheter body with an outer surface and an inner surface defining an internal cavity having at least at least one collar; a needle having a needle tip at a distal end and a proximal end attached to a needle hub, said needle extending through the catheter hub and through the catheter tubing, and wherein the needle tip protrudes from the distal end hole in a ready-to-use position; a valve having a disk-shaped valve body, the disk-shaped valve body including at least one slot and at least two leaflets, a proximally facing surface and a distal facing surface located in an internal cavity of the catheter hub; a valve actuator located in an internal cavity of the catheter hub, wherein said valve actuator has a nose portion and a proximal portion with at least one gap for fluid flow passing over or through it, and is movable between a proximal and distal position in the internal cavities when pressed with a medical instrument; and a locking device including a metal lock body containing a fluid passage, a distal end, a proximal end, and one or more leaf springs configured to create a proximally directed axial force vector onto the nose of the valve actuator.

The catheter sleeve body in accordance with the invention can be manufactured in one piece with an outer surface diameter significantly smaller than the Luer thread.

The one-piece hub body may have a distal end from which a catheter tube extends and a proximal end having a Luer cannula. The one-piece hub body can be custom made.

A fingertip pressure projection may be provided that may extend from the top of the catheter hub beyond the outer diameter of the luer thread.

Another aspect of the invention is a catheter assembly in which a proximally directed axial force is applied by a locking device, a valve, or both a locking device and a valve to a valve actuator to move the valve actuator from a distal position to a proximal position.

The invention may include a method of making or using a catheter assembly in which a proximally directed axial force is applied by a locking device, a valve, or both a locking device and a valve to a valve actuator to move the valve actuator from a distal position to a proximal position.

In addition, the invention may include a method for forming and using the catheter assembly presented herein.

Another aspect of the invention is a catheter assembly comprising: a needle attached to a needle hub; a catheter tube attached to the catheter hub; a valve and a valve actuator located in the interior of the catheter hub, said valve including a cut portion of a disc valve; and a locking device for holding the valve in the inner part; wherein the valve actuator is configured to repeatedly enter the valve to open the cut part of the disk valve in the open valve position and with the ability to exit the valve to return the cut part of the disk valve to the closed valve position; and the needle passes through the valve, valve actuator, catheter hub and catheter tubing in a ready-to-use position.

The retention device disclosed herein may be positioned proximally adjacent to the valve or proximally integral to the valve to retain the valve within the catheter hub.

The retaining ring or retaining device of the invention may include one or more leaf springs.

The retaining ring or retaining device of the invention may consist of a flange and two or more leaf springs extending from the flange.

The at least one leaf spring of the locking device may extend from the inner diameter of the flange and in a proximal direction, from a position radially outward from the inner diameter and in a proximal direction, or from a position radially inward from the inner diameter and in a proximal direction.

The proximal end of the at least one leaf spring may be flared or bent radially outward from a center line extending longitudinally through the locking device.

The catheter assembly may have a catheter hub including a wall with an outer surface and an inner surface defining a channel and a Luer thread or Luer eye in a proximal Luer opening.

The outer perimeter of the outer surface of the catheter hub may be smaller than the outer profile of the luer threads or luer ears.

The valve actuator described herein may be configured to engage within the valve when the Luer cone tip is connected to the catheter hub and to exit the valve when the Luer cone tip is disconnected from the catheter hub. The valve actuator can move from a distal position to a proximal position under the influence of force vectors generated by the valve, force vectors created by the locking device, or generated by both the valve and the locking device.

The valve may undergo at least three actuation cycles, with each actuation cycle including movement of the valve actuator into the valve to deflect the valve flaps and movement away from the valve to close the valve.

Another object of the invention is a catheter assembly including a catheter tube containing a cavity, a distal end opening and a proximal end attached to a catheter hub, wherein said catheter hub includes a catheter body with an outer surface and an inner surface defining an internal cavity having at least one shoulder; a needle having a needle tip at a distal end and a proximal end attached to a needle hub, said needle extending through the catheter hub and through the catheter tubing, and wherein the needle tip protrudes from the distal end hole in a ready-to-use position; a valve with a valve body including at least one slot, a proximally facing surface and a distally facing surface located in the internal cavity of the catheter hub and adjacent to the first collar near the distal facing surface of the valve; a locking device tightly adjacent to the proximally facing surface of the valve body and to the internal cavity of the catheter hub for retaining the valve in the internal cavity of the catheter hub, and the locking device includes an elastomeric material having elastic properties to store energy during deformation; a valve actuator located in an internal cavity of the catheter hub, wherein the valve actuator has a nose portion with a channel for fluid flow and a proximal portion with a structure with at least one gap for fluid flow passing over or through it, and is movable between the proximal position and distal position in the internal cavity when pressed with a Luer cone; wherein said valve actuator includes a protrusion for abutting the second collar to limit proximal movement of the valve actuator; wherein the valve drive includes a transition portion located proximally from the nose portion, and at least one plunger element located proximally from the transition portion.

The fixing device can be adjacent to the internal cavity of the catheter hub by an interference fit into the passage hole of the catheter hub, without an internal collar to rest against it.

The fixing device may be adjacent to the inner cavity of the catheter hub by abutting the inner collar.

The locking device may be an O-ring having a circular cross-section, an oval cross-section, or a polygonal cross-section. A particular polygonal section may include a square section or a rectangular section with four sides.

The valve drive design may include two drive elements spaced apart from each other.

The stabilizing element may connect two drive elements together, wherein the through hole is defined distal to the stabilizing element. In some examples, the second stabilizing element may connect two drive elements together to define a second through hole.

The needle safety mechanism may be located at least partially in the through hole of the valve actuator. The needle safety mechanism may be located at least partially in the second through hole of the valve actuator.

The valve actuator nose can be separated from the O-ring before advancing the valve actuator with the luer cone tip.

The nose valve actuator can be separated from the locking device before advancing the valve actuator with the tip of the luer cone.

The valve may include a plurality of valve blades, wherein the plurality of valve blades and the locking device may have stored energy when deformed by the valve actuator.

The stored energy of the plurality of valve leaflets and the locking device may exert a proximally directed force on the valve actuator to move the valve actuator from a distal position to a proximal position.

Another object of the invention is a catheter assembly, including: a catheter tube containing a cavity, a distal end opening and a proximal end attached to a catheter hub, wherein said catheter hub includes a catheter body with an outer surface and an inner surface defining an internal cavity; a needle having a needle tip at a distal end and a proximal end connected to a needle hub, said needle passing through the catheter hub and through the catheter tubing, and the tip of the needle protruding from the distal end hole in a ready-to-use position; a valve with a valve body including at least one slot and at least two leaflets, a proximally facing surface and a distally facing surface located in the internal cavity of the catheter hub and in contact with the first collar at the distal facing surface; a valve actuator located in an internal cavity of the catheter hub, wherein the valve actuator has a nose portion with a channel for fluid flow and a proximal portion with a structure having at least one gap for fluid flow passing over or through it, and is configured to move between proximal and distal positions in the internal cavity when pressed with a medical instrument; a locking device being an annular body including a flange having an outer diameter, an inner diameter, a thickness between a proximally facing surface and a distally facing surface, at least one leaf spring extending from a proximal passage opening of the flange in a proximal direction; wherein said flange is in contact with the proximally facing surface of the valve and the internal cavity of the catheter sleeve, said leaf spring is located at a distance from said internal surface and said nose part in the proximal position of the valve actuator; and wherein the at least one leaf spring has a length, a width, and a thickness, and wherein the thickness of the spring is approximately equal to the thickness of the flange.

The locking device may be an eyelet consisting of a flange and at least two leaf springs extending from the flange. There may be three, four, five or more springs.

The at least one leaf spring may extend from the lug flange bore and in a proximal direction, from a position radially outward from the bore and in a proximal direction, or from a position radially inward from the bore and in a proximal direction.

The flange of the locking device may have an arcuate cross-section, with the distally facing surface having a convex surface and the proximally facing surface having a concave surface.

The locking device may have at least one leaf spring extending in the vicinity of the passage opening of the flange having an arcuate cross-section.

The fixation device can remain in the inner cavity of the catheter hub due to the tension fit into the inner surface of the catheter hub. Optionally, the locking device may be adjacent to the inner collar of the catheter hub to remain in the inner cavity of the catheter hub.

The flange and leaf springs can be formed from the same metal sheet. The flange and leaf springs can be formed individually. The flange may have a thickness and each leaf spring may have a thickness such that the thickness of the flange and the thickness of each leaf spring are the same or approximately the same, within the thickness tolerance of the metal sheet.

The needle safety mechanism is located between the two plunger elements of the valve actuator. The needle guard mechanism may have at least one collar and a proximal wall with a perimeter defining an opening.

The thickened portion of the needle may come into contact with the perimeter of the opening of the proximal wall of the needle guard mechanism.

A pair of slots or cutouts may be located on either side of the at least one leaf spring of the eye.

The cutout may extend through at least two points on the outer arc of the eye flange.

The notch may be aligned to a different radius than the at least one leaf spring.

The locking device may include three spaced apart leaf springs extending proximally along the inner diameter of the flange.

At least two cutouts may be provided on the outer diameter of the eye flange with three spaced apart leaf springs, each cutout passing through at least two points of the outer arc of the flange.

The length of the leaf spring of the locking device may be less than the length of the bow. The leaf spring can contact the nose only when pressed by the valve actuator, and not with any other part or parts of the valve actuator.

Another aspect of the invention may be a catheter assembly comprising: a catheter tube containing a cavity, a distal end opening and a proximal end attached to the distal end of a catheter hub, wherein said catheter hub includes a catheter body with an outer surface and an inner surface defining an internal cavity, having at least one shoulder; a needle having a needle tip at a distal end and a proximal end attached to a needle hub, said needle extending through the catheter hub and through the catheter tubing, and wherein the needle tip protrudes from the distal end hole in a ready-to-use position; a valve having a valve disk and a skirt portion extending from the valve disk, the valve disk comprising at least one slot and at least two flaps, a proximally facing surface and a distally facing surface, and said skirt portion having a wall with an outer surface and an inner surface defining an inner surface of the skirt and a proximal end surface of the skirt, the valve being located in the inner cavity of the catheter hub, the distally facing surface contacting the first collar, and said skirt portion contacting the inner cavity; a valve actuator located in an internal cavity of the catheter hub, the valve actuator having a nose portion with a drive end at the most distal end of the nose portion and a fluid flow path, two spaced apart beads located proximally from the drive end, each valve actuator bead including an abutment edge and a proximal portion with at least one gap for fluid flow passing through or over it, and configured to slide between a proximal position and a distal position in the internal cavity when pushed by a medical instrument, the nose portion being located at least partially in the inner cavity of the skirt in a ready-to-use position; wherein said abutment edges of two spaced apart valve actuator flanges are positioned proximally from a proximal end surface of the skirt in a ready-to-use position to press against said skirt portion when the valve actuator is advanced by the tip of the luer cone.

The surface-protective needle safety mechanism may be positioned lateral to the needle in a ready-to-use position and extend to a position distal to the needle tip in a protected position to protect the needle tip from accidental puncture.

The skirt portion may be generally cylindrical in shape with a ramp-shaped section, in which case the proximal end surface may be located at the proximal end of the ramp-shaped section.

The skirt portion of the valve may be adjacent to a second collar in the internal cavity of the catheter hub.

The wall of the skirt portion may be thick, in which case the proximal end surface of the skirt may be open radially inward from the second flange.

The valve actuator nose portion may have a first slope extending into a transition portion, wherein the transition portion may have a second slope, the second slope and the first slope having different slope angles.

The valve actuator nose portion may have a first slope extending into the transition portion, wherein the transition portion may have a constant diameter portion without slope.

The valve disk may have a first portion of a first thickness and a second portion of a second thickness, wherein the first thickness is greater than the second thickness.

One or more slots for forming two or more valve flaps may be formed by a second valve disk portion of a second thickness.

Another object of the invention is a catheter assembly, including: a catheter tube containing a cavity, a distal end opening and a proximal end attached to a catheter hub, wherein said catheter hub includes a catheter body with an outer surface and an inner surface defining an internal cavity containing at least at least one collar; a needle having a needle tip at a distal end and a proximal end attached to a needle hub, said needle extending through the catheter hub and through the catheter tubing, and wherein the needle tip protrudes from the distal end hole in a ready-to-use position; a valve having a disk-shaped valve body, the disk-shaped valve body including at least one slot and at least two leaflets, a proximally facing surface and a distal facing surface located in an internal cavity of the catheter hub; a valve actuator located in the internal cavity of the catheter hub, wherein said valve actuator has a nose portion and a proximal portion with at least one gap for fluid flow passing over or through it, and is configured to slide between a proximal and distal position in the internal cavities when pressed with a medical instrument; and a locking device located proximally from the valve, wherein said locking device includes a metal annular body having a fluid passageway, a distal end, a proximal end, and at least one leaf spring formed on the metal annular body and extending proximally inward from the proximal curved edges.

The annular body of the locking device may have a proximal edge, and at least two cuts are made through the proximal edge to form at least one leaf spring.

The locking device may contain three spaced apart leaf springs.

The at least one leaf spring may be hinged or rotatable relative to the metal annular body of the locking device or flange.

At least one leaf spring is separated from the metal annular body by at least one slot or cut.

The locking device may have a proximal portion located between two adjacent leaf springs, and the proximal portion may have a width that is greater than the width of either leaf spring.

The at least one leaf spring may be spaced from the inner surface of the catheter hub when the locking device is positioned within the catheter hub to support or secure the valve.

The at least one leaf spring may be spaced from the valve actuator nose in a proximal valve actuator position and may be in contact with the valve actuator nose in a distal valve actuator position.

There may be two or more leaf springs formed by cutting at least four notches or recesses through the proximal edge of the annular body. Since the proximal edge of the annular body is cut or taken out, proximal portions may be formed at the proximal end of the annular body. The proximal portion may be located between two adjacent leaf springs. The proximal portion or portions of the annular body allow the curved edge of the annular body to flex during installation of the locking device into the catheter hub or upon contact with the nose portion of the valve actuator.

The locking device may include an eye having a flange and two or more leaf springs extending from the flange, wherein the flange has an outer diameter and an inner diameter, wherein at least one cutout can be made on the outer diameter and wherein the cutout extends through two points spaced apart along an arc of outer diameter.

The locking device may include an eye having a flange and two or more leaf springs extending from the flange, wherein the flange has an outer diameter and an inner diameter, wherein at least one cutout can be made on the outer diameter and wherein the cutout extends through two points spaced apart along an arc of internal diameter. A leaf spring may be located between two spaced points along an arc of the inner diameter.

The catheter assembly described herein may also be referred to as a needle device or needle catheter assembly. The device or assembly may have a catheter hub with a catheter tube, a needle hub with a needle attached thereto, the needle extending through the catheter hub and a lumen of the catheter tube.

A vent plug may be located at the proximal end of the needle hub. The plug can be attached to the proximal hole of the needle hub.

Another object of the invention is a catheter assembly, including: a catheter tube containing a cavity, a distal end opening and a proximal end attached to a catheter hub, wherein said catheter hub includes a catheter body with an outer surface and an inner surface defining an internal cavity having at least at least one shoulder. A needle having a tip at a distal end and comprising a proximal end attached to a needle hub; said needle may pass through the catheter hub and catheter tubing, and the tip of the needle protrudes distally from the distal end hole in a ready-to-use position. A disc-shaped valve located in the internal cavity of the catheter hub, wherein the valve disc may include at least one slot and at least two leaflets, a proximally facing surface and a distal facing surface, wherein said distally facing surface is in contact with a at least one shoulder. A skirt portion may extend from the valve disk, the skirt portion including a wall with an outer surface and an inner surface defining an inner surface of the skirt and a proximal end surface of the skirt, wherein the skirt portion may contact an inner surface of the catheter hub. In an alternative embodiment, the locking device may be located proximally from the valve disk, and the locking device may be a metal annular body comprising a fluid flow path, a distal end, a proximal end, and at least one leaf spring having a free end extending proximally inward. from the proximal end, while the locking device protects the valve from proximal displacement. The valve actuator may be located in an internal cavity of the catheter hub, wherein the valve actuator may have a nose portion at a distal end and a proximal portion proximal to the nose portion; the nose portion includes a fluid flow passage and a drive end at the most distal end of the nose portion. The proximal portion may have at least one gap for fluid flow passing through or over it. The valve actuator may be located in a proximal position in the internal cavity and is configured to slide to a distal position in the internal cavity when pressed by a medical instrument. If there is a skirt section, the nose part is located at least partially in the inner part of the skirt in a ready-to-use position; in the presence of a fixing device, the nose part can be located inside the metal annular body in a ready-to-use position; and if there is a skirt portion, two spaced apart adjacent surfaces are located proximally from the drive end of the valve actuator and proximally from the proximal end surface of the skirt in a ready-to-use position, wherein the adjacent surfaces are sized and shaped to abut the proximal end surface of the skirt, when the valve actuator is in the distal position, or, in the presence of a locking device, at least one leaf spring is located at a distance from the nose and is pressed by the nose when the valve actuator is in the distal position.

The needle guard mechanism may have a protective surface located lateral to the needle in a ready-to-use position and extending to a position distal to the tip of the needle in a protective position to protect the tip of the needle from inadvertent puncture.

The skirt portion may have a ramp-shaped cross-section, and the proximal end surface of the skirt may be located at the proximal end of the ramp-shaped cross-section.

The valve actuator nose portion may have a first slope extending into the transition portion, wherein the transition portion may have a second slope, wherein the second slope and the first slope may have different slope values.

The valve disc may have a first portion of a first thickness and a second portion of a second thickness, wherein the first thickness may be greater than the second thickness.

At least one slot may be formed through the second valve portion.

The at least one stabilizing element may include a first end coupled to a first valve actuator plunger element and a second end coupled to a second valve actuator plunger element, wherein the stabilizing element may also include a distal edge and a proximal edge.

The distal end may have a beveled edge. The beveled edge may extend closer to the outer surface than the inner surface.

The needle guard mechanism may include a proximal wall having a perimeter defining an opening, and at least one tab extending distally from the proximal wall, wherein at least one tab includes an elongated tab portion, a distal wall, and a corner portion located between the elongated tab portion and the distal wall, and a simple bend may be provided between the elongated portion of the tab and the distal wall to provide a smooth or flat profile at the corner portion where the needle guard contacts the distal edge.

The catheter hub may include a side port having an elongated body with a channel, wherein the elongated body may extend at an angle to the catheter body. A length of tubing may be connected to the side port at its first end. A fluid connection device may be connected to the second end of the tube length. The fluid connection device may be a needle-free valve.

Laterally from the axis defined by the needle, a wide gripping body can extend.

The distal edge of the stabilizing element may include a tapered edge that extends proximal to the outer surface of the stabilizing element and slopes toward the inner surface of the stabilizing element.

A needle guard mechanism with one bend or one change of direction on one or both legs of the needle guard mechanism may be particularly useful with a valve actuator containing a stabilizing element. A needle guard mechanism with one bend or one change of direction on one or both legs of the needle guard mechanism may be particularly useful with a valve actuator having a stabilizing element with a distal edge comprising a beveled edge. The beveled edge and single bend or change of direction can minimize the catching point or engagement point between the needle guard and the valve actuator during retraction of the needle guard after successful venipuncture.

The invention also provides a method for manufacturing an intravenous catheter assembly. The method includes: attaching a catheter tube having a lumen, a distal end hole and a proximal end in relation to the distal end of the catheter hub, wherein the catheter hub includes a catheter body with an outer surface and an inner surface defining an internal cavity having at least one shoulder. The method also includes attaching a needle having a needle tip at a distal end and a proximal end to a needle hub; wherein the needle passes through the catheter hub and through the catheter tube and has a needle tip protruding distally from the distal end hole in a ready-to-use position. The method also includes placing a valve in the form of a disk in the internal cavity of the catheter hub, wherein the valve disk includes at least one slot and at least two leaflets, a proximally facing surface and a distal facing surface, wherein the distally facing surface contacts at least one collar. The method involves extending the valve disc with a skirt section, wherein the skirt section includes a wall with an outer surface and an inner surface defining the inner surface of the skirt and the proximal end surface of the skirt, wherein said skirt section is in contact with the inner surface of the catheter hub; or placing a locking device in the internal cavity of the catheter hub and proximally from the valve disc, the locking device comprising a metal annular body having a fluid passage, a distal end, a proximal end, and at least one leaf spring having a free end extending proximally inward from the proximal end, and the locking device protects the valve from proximal displacement. In addition to the above steps, the method includes placing a valve actuator in an internal cavity of the catheter hub, the valve actuator having a nose portion at a distal end and a proximal portion proximal to the nose portion; the nose portion includes a passage for fluid flow and an actuator end at the most distal end of the nose portion, and the proximal portion has at least one gap for fluid flow through or along it, wherein the valve actuator has a proximal position in the internal cavity and is movable to a distal position in the internal cavity when pushed by a medical instrument, wherein: in the presence of a skirt section, the nose part is located at least partially in the internal section of the skirt in a position ready for use; or if there is a locking device, the nose part is located inside the body of the metal ring in a ready-to-use position; and if there is a skirt portion, two spaced apart abutment surfaces are located proximally from the drive end of the valve actuator and proximally from the proximal end surface of the skirt in a ready-to-use position, the abutment surfaces being sized and shaped to abut the proximal end surface of the skirt, when the valve actuator is in the distal position, or in the presence of a locking device, at least one leaf spring is located at a distance from the nose portion and is offset relative to the nose portion when the valve actuator is in the distal position.

In addition, the method may further include the step of placing a needle guard mechanism in the internal cavity of the catheter hub, wherein the needle guard mechanism has a protective surface located lateral to the needle in a ready-to-use position and extending to a position distal to the tip of the needle in a protected position to cover the tip. needles from an accidental injection.

In this case, the needle protective mechanism contains a proximal wall having a perimeter defining the hole, and at least one leg extending distally from the proximal wall, wherein at least one leg contains an elongated part of the leg, a distal wall and an angular element located between the elongated part of the leg and the distal wall, with one bend located between the elongated portion of the tab and the distal wall to provide a smooth or flat profile at the location of the corner element where the needle guard mechanism contacts the distal edge.

In addition to the above steps, the method may further comprise the step of forming a side port comprising an elongated body with an opening at an angle to the catheter body.

In the ready-to-use position, a needle bevel may protrude from the distal orifice of the catheter tubing at the tip of the needle. The ready position may be a position in which the assembly or device can be used to perform an injection or puncture. The needle hub may be connected to the catheter hub at a proximal opening of the catheter hub, which may have an internal Luer thread or Luer slip.

The catheter hub may include a pressure projection and one or more surface features, such as ridges, for pushing the catheter surrounding the needle into a vein of the patient. The needle hub may similarly include surface features to provide a more secure grip when puncturing the vein and removing the needle from the catheter. Unless otherwise indicated, the various components of the device or catheter assembly can be manufactured from conventional materials using conventional methods.

In one example, a pair of wings may be incorporated into the catheter hub body, with each wing extending laterally from the longitudinal axis of the catheter hub in opposite directions at the bottom of the catheter hub. The pair of wings can be used by the physician to secure the catheter hub to the patient after successful venipuncture, for example using adhesive tape or an adhesive bandage.

The catheter hub may be provided with a valve and a valve actuator to control the flow of fluid through the catheter hub, for example to control infusion or aspiration through the catheter hub. Integrated with the catheter device or assembly may be a needle guard mechanism or a needle tip guard, which may have a surface or wall to prevent accidental contact with the needle tip when withdrawing the needle from the catheter tube and catheter hub after successful venipuncture.

The needle safety mechanism or needle tip protector may include a structure with one or more components to prevent accidental contact with the needle tip. For example, the needle guard mechanism may have a structure or wall that moves from a position lateral to the needle shaft and proximal to the needle tip to a position distal to the needle tip to cover or block the needle tip from accidental contact. In one example, the needle safety mechanism may be one of the types described in US Pat. No. 10,166,370.

The catheter hub has a body with an outer surface and an inner surface defining an internal cavity. One or more collars or stop projections may be included in the internal cavity and may be used to seat the valve actuator, valve, and/or needle guard mechanism in a ready-to-use position. The needle guard mechanism may be placed in the internal cavity of the catheter hub by the nose portion of the needle hub, which is configured to fit into the proximal opening of the catheter hub.

The needle assembly or catheter assembly may be provided with a catheter hub having an interior with a valve, a valve actuator, and a needle guard disposed therein in a ready-to-use position. In one example, the needle guard mechanism is optional and can be omitted. In other examples, the needle protection mechanism may be located substantially external to the catheter hub. For example, the finger or finger portion of the needle guard may be located within the catheter hub, and the remaining structure of the needle guard may be located outside the catheter hub.

A catheter device or assembly of the invention may include a device or structure for securing or retaining a valve within a catheter hub, which may generally be referred to as a locking device, a locking ring, or a locking element. The retaining device, ring or element may have a structure that is a retainer, a retaining ring, a retaining skirt, an O-ring of various possible cross-sections such as round, oval, square, rectangular, or a conical coil spring, among others.

The locking device may be formed separately from the valve or be part of the valve, for example, used in conjunction with the valve, integrated with the valve, or integrally formed with the valve. Unless the context indicates otherwise, the term locking device may refer to any of the above structures and their equivalents for securing a valve within a catheter hub and may optionally include elements for interacting with or generating force vectors to return the valve actuator from a distal position to a proximal position. In one example, the locking device is positioned in line with the valve, the valve actuator, and the needle guard.

In a specific example, the locking device has a channel or opening to receive a needle and is in contact with both the valve and the interior of the catheter hub to limit proximal movement of the valve to the interior, to assist in returning the valve actuator from a distal to a proximal position, or to both purposes, as discussed in more detail below. The valve actuator or part of the valve actuator can be located inside the channel of the fixation device both in the ready position of the catheter assembly and in the operating position, for example, subsequent successful venipuncture, which will be discussed in more detail below.

The needle protection mechanism may include a metal body with springy or resilient properties, a proximal wall, and at least one tab or two tabs extending distally from the proximal wall. A thickened portion may be formed on the shaft of the needle proximal to and adjacent to the tip and engage the perimeter of the hole in the proximal wall to limit distal movement of the needle guard relative to the needle but allow the tip to enter the needle guard. The thickened portion may include a corrugation, bead of material, sleeve, or any other diameter increasing element that will be larger than the opening in the proximal wall.

The valve, valve actuator, locking device, and needle guard mechanism may be sized and shaped to be located within the interior of a catheter hub, which may have a one-piece hub body, such as a monolithically formed hub body comprising a proximal port with an internal Luer thread. and a distal end from which the catheter tube extends. The open proximal end may optionally include male threads or ears. In other examples, the catheter hub may be made from multiple parts of the hub body. For example, the catheter hub may have a first hub body attached to a second hub body, such as by gluing or welding, to form the catheter hub body.

In one example, the valve actuator may include a nose portion at a distal end of the actuator body. The nose portion may have an elongated structure and may be generally cylindrical or angled or tapered, terminating at a driving end for pushing into the valve and opening the valve slots, as described in more detail below. The driving end of the nose may have a blunt distal end surface or a sharp edge. A channel may extend through the nose portion for fluid flow. The nose portion may have a wall surface with a continuous circumference or a continuous perimeter portion defining a lumen or passage for flow. The wall of the bow can be without a gap or slot, for example, in the form of a cylinder with a continuous wall. The nose part can define the channel.

The wall in the bow can be solid. However, one or more through-holes may be provided in the nose to allow fluid to pass through, for example for flushing purposes. The hole in the nose may have a constant diameter or may vary depending on the taper of the nose. In some examples, a plurality of spaced slots and/or openings may be provided on the nose portion, such as in the wall of the nose portion, to provide fluid flow or flushing.

Two actuator or plunger elements may extend proximally from the nose portion. For example, two plunger elements may be integrally formed with the nose portion and may extend proximally from the nose portion. A gap or space may be provided between the two plunger elements, which may define a holding space.

The needle guard mechanism or needle tip protector may be located in the holding space or between two plunger elements. In one example, the two plunger elements may comprise at least two longitudinal edges, which may be spaced apart from each other. The longitudinal edges of the plunger elements may coincide with the longitudinal axis of the valve actuator. A gap or space may be provided between the two plunger elements to function as a flow path for fluid passing through or over it as the fluid passes through the catheter hub.

In other examples, there may be more than one gap or flow path defined in the valve actuator for fluid flow. In other examples, two plunger elements may be connected by two bridges such that the proximal end of the valve actuator is a continuous wall structure formed from two plunger elements and two bridges. In some examples, the valve actuator uses a single plunger element.

In one example, the protrusion may extend outward from the outer surface of one or both plunger elements. The protrusion may extend from the outer surface of each plunger element. Each protrusion may be like a support having a generally flat edge for abutment against a collar or edge formed in the interior of the catheter hub. The surface of the protrusion and the direction of the protrusion are configured to engage the valve actuator into the interior of the catheter hub and seat it within the catheter hub, as described in more detail below. The protrusions are sized and shaped to abut or contact a collar inside the catheter hub to limit proximal movement of the valve actuator.

In one example, the transition portion extends from the nose and expands as the valve actuator body expands axially in a proximal direction. Two drive elements are configured to exit from the transition section. Two drive elements in an alternative design are designed to exit from the nose without a transition section. In some embodiments, the nose portion may have another shape, such as cuboid, rectangular, conical, pyramidal, chamfered, or the like.

In one example, the valve actuator has a longitudinal axis, with one or more actuating elements located along or parallel to the longitudinal axis. In a specific example, two drive elements are located diametrically opposite each other along the longitudinal axis. In other examples, the two drive elements may move away from each other as they move proximally. In other examples, the two drive elements may converge toward each other as they move proximally.

The distance between two plunger elements, whether straight, converging or diverging, may define the holding space between them. As shown, the two drive elements define an outer diameter having a dimension larger than the diameter of the nose. For example, the diameter defined by the two plunger elements at the proximal end may be greater than the diameter defined by any portion of the nose portion except the protrusions. In some examples, the diameter defined by the two plunger elements is simply larger than the drive end at the nose.

In some examples, the nose portion of the valve actuator has a contoured shape, such as with distinct lines or curves, obtained by forming recesses in the nose portion with distinct contour lines or curves. One or more surfaces of the complex shaped nose piece can then be used to press against the valve and recoil the valve while pushing the complex shaped nose piece in a proximal direction to return the valve actuator to the proximal position.

In some examples, the actuator is made of a rigid material, such as plastic or metal, and the nose of the valve actuator includes a more flexible portion, which is also understood to be more compliant than the rest of the valve actuator. For example, the flexible portion may be a strip or tape of a softer material than the base material used to construct the valve actuator. The flexible portion may be added to the valve actuator as an elastomeric strip or molded together with the valve actuator. The flexible portion, being pliable, can help return the valve actuator from a distal to a proximal position.

In one example, the drive elements are flexible and flexible such that when pressed by a luer cone, such as a syringe tip or luer cone adapter, the drive elements can deflect or flex. The drive elements can be deflected by selecting a material that has the necessary elastic properties. In other examples, the drive elements may be deflected by including one or more weakened portions, such as by including a structurally thin portion, by including notches, by using a small cross-section relative to other portions of the same elongated plunger element, or combinations thereof. . In an alternative design, the plunger elements can be flexible and deformable by selecting a material having the necessary elastic properties and including one or more weakened areas.

In other examples, each plunger element has more than one different cross-sectional profile or contour along a length portion. For example, the elongated plunger element may have a square profile adjacent to a crescent-shaped profile.

In one example, the drive elements are rigid and do not deflect or deform under load, such as when pushed by the tip of a luer cone. Further, one or more stabilizing elements may be included to increase the rigidity of the two drive elements. Each of the two actuators may include a cross-sectional profile at least at a proximal end that overlaps the push end of the luer cone such that the luer cone can push the valve actuator into the interior of the valve, as described in more detail below. The stabilizing elements may have proximal edges that are distal to the proximal edges of the drive elements or are flush with the proximal edges of the drive elements.

The valve actuator nose portion is configured to engage the valve to open the valve flaps and slots formed therebetween when an axial force is applied by the pin end to the actuator elements to engage the valve actuator into the valve to deflect the valve flaps, such as during insertion male portion of the Luer line or IV set.

Typically, the valve actuator nose is rigid relative to the more compliant valve, allowing the nose, or more specifically the driving end of the nose, to actuate the valve, such as deflecting one or more flaps and opening one or more valve slots. The nose piece may be made of an incompressible material, such as metal, rigid plastic, or hard elastomer, to press against and open the valve. However, the nose portion may further include a more pliable portion. For example, the nose piece may include or be with an elastomeric strip, strip or section.

A pair of opposing strips or stabilizers may be provided between the nose and the proximal end of the drive elements connecting the two drive elements along their length. In some examples, stabilizers may be located at the proximal end of two drive elements such that the proximal edges of the stabilizers are generally flush with the proximal end surfaces of the drive elements. The two stabilizing elements or strips may be called a first or upper stabilizing element and a second or lower stabilizing element in the height direction.

In one embodiment, stabilizers or stabilizing elements with arc-shaped wall surfaces form an arc that generally follows the internal profile of the catheter hub and connects one plunger element to another plunger element. The stabilizers or stabilizing elements may form a substantially continuous cylindrical portion on the valve actuator body, which is formed by two stabilizing elements and two plunger elements spaced from the nose of the valve actuator. In other words, the valve actuator may be elongated and may have portions that are radially continuous and portions with relief shapes or through passages through the actuator wall that are not radially continuous.

In one example, the stabilizers define a continuous body portion along the perimeter or radial direction of the valve actuator that is spaced from a continuous body portion of the nose portion that is also continuous along the perimeter or radial direction. Two stabilizers or stabilizing elements, also called strips, can be connected together with two plunger elements to form a ring structure.

If desired, the two stabilizers can be slightly offset and positioned at an angle to each other in the longitudinal direction of the valve drive. In some embodiments, there may be one, three, or other number of drive elements or stabilizers. For example, there may be two drive elements, but only one stabilizer or strip. In one example, the valve actuator with stabilizers or stabilizing elements and projections is made of plastic, for example by injection molding.

Stabilizers can help the valve actuator remain centered in the catheter hub when the actuator or actuator element is moved, such as by pressing a luer cone, to force the nose to open the valve slots. By remaining centered, the nose can be better aligned with the valve disc, such as with slots on the valve disc, allowing for smooth valve actuation. Stabilizers can also provide frictional adhesion to the inside of the catheter hub to prevent the actuator from sliding proximally after the Luer cone is withdrawn. However, as discussed above, projections may be included in the valve actuator to engage an internal collar or edge within the catheter hub to retain the valve actuator within the catheter hub.

In one embodiment, the nose portion is configured to remain engaged with the valve disc after the valve has been actuated and after the luer cone has been removed. For example, the nose piece may be wedged between one or more slots on the valve disc and held there by friction. On the valve actuator, for example, on the nose, surface features such as ridges, grooves, or serrations may be provided to maintain engagement between the actuator and the valve after the actuator has been actuated and after the luer cone has been removed.

In a preferred embodiment, the valve actuator does not interact with the valve after the luer cone is removed. In a preferred embodiment, the valve actuator can be moved from a distal position, pressed against the valve, to a proximal position, away from or minimally touching the valve, but allowing the valve flaps to return or close the slots.

When the valve actuator returns to the proximal position after removal of the luer cone, the valve may close to prevent or restrict fluid flow through the valve. The valve may reopen if the valve actuator is moved distally by a pin-type medical instrument, such as a syringe tip or an IV set tip. Because the valve actuator can move to a distal position in the valve, such as when pushed with a luer cone, to open two or more valve leaflets, and can return to a proximal position when the luer cone is removed to allow the valve leaflets to relax or close to close the slot, the valve may go through several actuation cycles. In one example, the valve may undergo two or more actuation cycles. For example, the valve may undergo at least two actuation cycles, at least three actuation cycles, at least four actuation cycles, at least five actuation cycles, or more. Each actuation cycle may include movement of the valve actuator into the valve, or to a distal position, to deflect the valve leaflets, and movement of the valve actuator away from the valve, or to a proximal position.

At least one relief shape, hole, or passageway may be provided between the valve actuator transition portion and the proximal end of the valve actuator. The transition area can be understood as the area located proximal to the distal end of the drive or from the nose to the two stabilizers. In one example, two relief shapes or through passages are included to provide clearance so that the inner or central portion of the valve actuator and the inner surface of the catheter hub can be in open communication. In other words, one or two relief shapes, through passages or openings for fluid flow, such as flushing, are located between the continuous nose portion and the continuous perimeter portion defined by the two stabilizers and plunger elements called the stabilizing ring. Through holes or raised shapes can also be used to support the needle guard mechanism, which will be discussed in more detail below if it is included in the design.

The valve actuator stabilizing ring may have an internal diameter that is less than the diameter defined by the diagonal portion or corner members of the two arms of the needle guard mechanism when the two arms are extended by the side of the needle shaft in the ready-to-use position. Thus, during installation of the needle guard into the valve actuator holding space, the diagonal portion or corners of the needle guard may be deflected to pass through the stabilizing ring into open areas defined by relief shapes or through holes.

When the needle tip guard is positioned between the two plunger members, two distal walls of the needle guard, and more specifically two diagonal portions or corners of the needle guard, may be arranged in relief shapes to engage the guard contact surface on the inner surface of the catheter hub. This allows the needle guard mechanism to protrude from the valve actuator retaining space through the two relief shapes to engage the contact surface of the catheter hub. Thus, the needle guard can be held within the catheter hub in the ready-to-use position and during needle retraction after successful venipuncture until the needle tip has moved proximal to the two distal walls of the needle guard, at which time the needle guard can close over the tip. needle, the distal end of the needle guard mechanism becomes smaller in diameter than the inner diameter of the valve actuator of the stabilizing rings and can be removed along with the needle.

A cutout or recess may be provided in the internal cavity of the catheter hub to accommodate two bent or angled sections of the needle protection mechanism. Thus, the shoulder of the recessed portion or some other surface of the inner cavity of the catheter hub, such as the engagement surface of the needle guard mechanism on the inner cavity of the catheter hub, may prevent the needle guard mechanism from sliding proximally during retraction of the needle after successful venipuncture. Additionally or alternatively, the distal edge of one or both stabilizers may be provided as a holding surface to prevent premature activation of the needle guard during retraction of the needle before the tip of the needle has moved proximal to the two distal walls of the needle guard. In addition to a distal edge, each stabilizer may have a proximal edge.

When the needle guard is supported by one or both distal edges of the stabilizers, the inner surface of the catheter hub may not have an engaging member or features to accommodate the corner portions of the needle guard. In one example, the needle guard mechanism may engage one or both distal edges of two stabilizers and engage an engaging member or features formed within the catheter hub, such as a groove, edge, or collar.

In some examples, one or both stabilizer elements may have a slot or channel, thereby dividing the arcuate stabilizer element or stabilizer element into two segments. Even if there is a slot on one or both of the stabilizing members, the stabilizing ring, which may not be a solid ring like a ring with one or more slots extending through the ring, may still provide a retaining structure to engage the two corner portions to prevent premature activation of the needle safety mechanism while retracting the needle before the needle tip moves proximal to the two distal walls.

The retaining surfaces of the stabilizer elements, such as the distal edges, may be referred to as the stop point, stop gap, or engagement point because they provide a rigid structure that prevents the needle guard from moving proximally until or unless the needle guard is first activated. and will not compress radially to reduce its radial profile and then slide proximally away from the engagement point. In one example, one or two corner portions of the needle guard may be constrained to engage from proximal movement until one or two corner portions of the needle guard are deflected to reduce the radial profile of the needle guard. In one example, when the radial profile of the needle guard is reduced, the needle guard may slide through the channel defined by the stabilizing ring from a distal position of the stabilizing ring to a proximal position of the stabilizing ring.

The valve actuator can be made of metal material or plastic. If the valve actuator is made of a metallic material, it can be formed by bending or deep drawing methods, and the arcuate cross-section of the plunger element can provide additional rigidity when it is pushed by the luer cone. Each plunger element may include at least two longitudinal edges, and a rib may be provided along one or both longitudinal edges to provide additional structural rigidity. One or more gaps may be provided between any two plunger elements. The gaps may provide clearance or space for fluid to flow, such as during blood flushing or intravenous infusion. The clearance between the plunger elements may define a holding space to accommodate the needle guard mechanism.

In some embodiments, most, if not all, of the needle guard mechanism is placed in the holding space defined by the actuator body between two plunger elements in a ready-to-use position, as described in more detail below. This configuration allows the catheter hub to be made more compact, since less longitudinal space within the hub is required to install the valve actuator and needle guard mechanism in series in the longitudinal direction or partially overlapping in the axial direction.

Embodiments of the invention, including the use of the noted locking device and various other components, can be used with or on commercially available needles, for example, 24 gauge to 14 gauge.

When the needle guard engages only the distal edge of a raised or through passage in the valve actuator, then no deformation or change in diameter of the inner wall of the catheter hub is required, and the needle guard can be positioned proximally in the tapered portion of the Luer cannula while maintaining the international Luer standard for conical fittings, and the overall length of the catheter hub can be further reduced.

The valve of the present invention may have a first portion with a first thickness and a second portion with a second thickness that is less than the first thickness measured orthogonal to a medial plane passing through the diameter of the valve. The second portion with a second thickness may have a substantially constant thickness, but optionally may have a variable thickness along the valve cross section of the second portion.

In one example, the second portion is formed by recessing the distally facing surface of the valve, the proximally facing surface of the valve, or both surfaces, while the first portion retains substantially the entire width or thickness of the valve between the proximal and distal facing surfaces. In one example, the recesses in the second portion may be cutouts formed in the valve.

The appearance of the surface between the first and second parts may resemble a three-leaf clover. Three-leaf clover may be present on the distal facing surface, the proximally facing surface, or both surfaces of the valve. In other examples, the surface appearance of the proximally and/or distally facing surfaces may have different contours, such that the three-leaf clover may have contours with different curves, lines, and edges.

In one example, slits are formed through a thinner second portion of the valve to form valve flaps between adjacent valve slits. In some examples, there may be two or more slots defining one or more valve flaps. For example, the first and second valve portions may define a four-leaf clover, which may have four slots and four valve flaps. In a preferred design, the valve may have three slots and three valve flaps. The slots may begin at approximately the central location of the valve and extend radially outward toward, but not all the way to, the outer perimeter of the valve. The length of each slot can be varied to form valve flaps of different sizes. The length of the slots can be selected to provide the desired valve flaps and to deflect the valve flaps when the nose portion of the valve actuator is pressed, for example, when the actuating distal end of the valve actuator is pressed.

The valve can be formed entirely from one material. Alternatively, the valve may be formed from different materials in different parts of the valve for reasons such as improved rigidity or flexibility. The valve can be made from medical grade elastomer or thermoplastic elastomer (TPE). Valve embodiments may be implemented in accordance with the valve examples disclosed in PCT Application No. PCT/EP2017/070934, published as PCT Publication WO 2018/033626 A1, the contents of which are incorporated herein by reference in their entirety.

The locking device may be a retaining ring, which may have an annular wall structure with an outer surface and an inner surface defining a channel. In some embodiments, the device for securing the valve within the catheter hub may be a retaining skirt, O-ring, or spring. The valve, valve actuator, and retaining device may have various shapes, styles, and characteristics but otherwise perform the designated functions described herein.

The valve may be a valve disc as described having at least one slot defining at least two flaps. The valve disc may have three or more slots, or a split valve disc portion defining three or more flaps, and the surface of the disc may have varying surface characteristics and thicknesses along a cross section of the valve disc. In other examples, the valve may have a valve disc and a skirt extending proximally from a proximally facing surface of the valve disc.

A catheter hub provided herein may have a valve, a valve actuator, a locking device, and a needle guard mechanism located within an internal cavity of the hub body, which may be a single hub body with a distal end from which a catheter tube extends and a proximal opening containing a cannula. Luera. The valve may be located distal to the locking device, the valve actuator portion may be located in the channel of the locking device, and the needle protection mechanism may be located in the retaining space of the valve actuator. In other examples, the needle protection mechanism may be absent or may be located outside the containment space, such as in a housing that is distinct or separate from the catheter hub.

In one example, the interior of the catheter hub is provided with one or more shoulders or projections, which can be understood as a structural edge or stop formed on the wall of the interior surface. One or more beads may provide engagement or resting points for components positioned in the internal cavity to prevent components from moving or being pushed out of the interior of the catheter hub. As shown, the valve may be located in the annular groove and may abut one of the shoulders to prevent proximal movement of the valve. The valve may also abut the collar of the catheter hub on the distal side of the valve to prevent distal movement of the outer perimeter of the valve.

A locking device or retaining ring in the form of an annular gap may be positioned adjacent to the valve and abut the proximal end of the locking device against another collar in the interior cavity of the catheter hub to prevent or limit proximal movement of the locking device.

In one example, the locking device has a cross-sectional shape of a ramp, triangle, or sloping surface with a tall portion of the ramp at a distal location and tapering proximally. The fixation device may be made from medical grade plastic material, such as by plastic injection. In other examples, the locking device may be made from a metallic material, such as by stamping and then forging, pressing, or machining. In other examples, the locking device may be made of an elastomeric material, such as an O-ring, to provide a proximally directed force on the valve actuator when compressed between the nose of the valve actuator and the inner wall of the catheter hub in the distal position. The O-ring can be deflected or deformed by the valve actuator to create stored energy in the O-ring, which can then apply a proximally directed force to the valve actuator when the stored energy is released.

The distal end of the locking device, the high portion of the ramp, may be adjacent to the proximally facing surface of the valve, and the proximal end of the locking device, the narrow portion of the ramp, may be adjacent to one of the beads of the internal cavity. This arrangement of the locking device may help keep the valve from moving proximally within the catheter hub. In some examples, the valve may be secured or supported within the catheter hub by a locking device without the use of a separate collar adjacent the proximal edge of the valve.

In one example, the locking device may have slight engagement upon first engagement with the proximal open end of the catheter hub and may have an interference fit or slight contact with the catheter hub in the end position shown. In other examples, the locking device may be retained within the catheter hub and prevent the valve from proximal displacement only by being an interference fit within the catheter hub without a separate collar adjacent to the proximal end of the locking device.

The locking device may be a retaining ring having a generally triangular cross-section. In other examples, the cross section may have a different shape, such as a complex shape.

In addition to securing the valve within the catheter hub, the retaining ring or locking device may also function as a return mechanism to assist the valve actuator to return or move from a distal to a proximal position. For example, when the valve actuator is advanced by the luer cone to open the valve slots, the retaining ring can help return the valve actuator to the proximal position after the luer cone is removed from the proximal opening of the catheter hub.

In some examples, the locking device only keeps the valve from moving proximally while the elasticity of the valve returns the valve actuator from the distal to the proximal position after removal of the Luer cone from the proximal opening of the catheter hub.

In some examples, the cross-section of the locking device may be chosen to be non-triangular in shape. In other examples, the section of the retaining ring may be designed as a retaining skirt and form part of the valve. For example, the valve may be formed as either a valve disc or a retaining skirt, for example by joining or molding as one piece.

In the example shown, the length of the valve drive is selected such that the driving or driving end at the distal end of the nose simply contacts the valve disc and the proximal edges of the two plunger elements simply contact the nose of the needle hub in the ready-to-use position. In other examples, the drive end may be slightly away from or slightly pressed against the valve disk, but not significantly deflect the valve flaps to allow the valve flaps to close its slots.

In one example, the valve actuator holding space may be sized and shaped to accommodate a needle safety mechanism. The needle safety mechanism may be located between the two plunger elements of the valve actuator. The needle guard, which may have a proximal wall and two legs located distal to the proximal wall, may be located in the valve actuator retaining space, with two corner portions of the needle guard located distal to the two stabilizing members. Thus, if the needle is retracted proximally, the two corner portions will be stopped from moving proximally past the two distal edges of the two stabilizing elements, which may act as an engagement point.

The radial dimension of the needle guard mechanism near the two corner portions may be greater than the internal dimension of the stabilizing ring and may therefore be physically stopped by the distal edges of the two stabilizing members. After successful venipuncture, the needle can be withdrawn from the catheter tube and catheter hub and the tip of the needle is moved proximal to the two distal walls of the needle guard, allowing the two arms of the needle guard to move inward or close together to reduce the radial dimension near the two corner portions. At about the same time, a thickened area near the tip of the needle may abut the perimeter of the hole in the proximal wall of the needle guard, and further retraction of the needle will remove the needle guard along with the needle.

As an example, the interior of the catheter hub may be enlarged at a location proximal to the two corner portions when the needle guard mechanism is positioned within the catheter hub. For example, the inner diameter of the catheter hub at the location of the two corner portions may be greater than the inner diameter of the catheter hub at the proximal wall of the catheter hub. This space can be added to provide a relief shape or additional space for the needle safety mechanism in the ready position. In other words, the relief mold, when added, provides space for the two tabs such that the two tabs do not compress or move inward at the two corner portions in the ready-to-use position to the same extent as when the relief mold is not provided. This can reduce the resistance between the needle shaft and the two curved ends at the ends of the two distal walls when retracting the needle after puncture.

The valve actuator may be retained in the internal cavity of the catheter hub and prevented from exiting the proximal opening by at least one side projection on the valve actuator to engage one of the beads in the internal cavity. The cross-sectional dimension of the valve actuator at least one protrusion may be larger than the cross-sectional dimension near the shoulder of the catheter hub, thereby providing a physical stop to prevent proximal extrusion of the valve actuator from the proximal opening of the catheter hub.

If the valve actuator moves proximally, for example, because the corner portions of the needle guard mechanism are pushed proximally toward the distal edges of the two stabilizing elements as the needle is retracted but before the needle tip moves proximal to the two distal walls, the overall proximal movement may be limited by the impact of the protrusion on one of the collars of the catheter hub. In one example, two projections, one on each plunger element, may be provided on the valve actuator to engage the collar, which may have an annular configuration.

Once the needle is removed, all leaflets of the valve are given the opportunity to retract or return to a deflated state to close or close the slots and restrict flow through the valve proximally and distally. The drive end at the nose of the valve actuator may be located within the hole defined by the locking device, but at a distance from the locking device, i.e. without contact with it until it is activated. The conical surface of the nose portion may also be spaced away from the locking device. This clearance allows the valve actuator element to move forward in a distal direction when pushed by the luer cone before it collides with or contacts the locking device.

In some examples, the Luer taper abuts the Luer cannula of the catheter hub to stop further distal advancement of the Luer taper into the catheter hub before the nose of the valve actuator contacts or presses against the interior of the locking device.

The driving end of the valve actuator may be in contact with the proximally facing surface of the valve after removal of the needle. In other examples, the drive end may be slightly away from the proximally facing surface of the valve after the needle is withdrawn.

As shown, the nose of the valve actuator may have an increasing taper in a proximal direction, which may be spaced away from the conical cross-sectional surface of the locking device ramp. The nose part is located so that its size and shape allow it to contact with the ramp-shaped section of the fixing device or to be at a distance from the ramp-shaped section. Alternatively or in addition, the locking device is positioned to be sized and shaped to contact the nose of the valve actuator as the valve actuator is advanced into the valve to deflect the valve flaps.

In one example, the nose piece may include a resilient portion or strip, such as an elastomeric strip, tape or strips, and may create a slight tension as the valve actuator moves distally to open the valve and as the nose piece abuts the locking device.

If the longitudinal axis of the catheter hub is taken to be the X-axis and the Y-axis is orthogonal to the X-axis, then the shape of the nosepiece can be chosen to both deflect the valve leaflets distally and to create force vectors that have both an X and a Y component. Force vectors acting in the X direction, a force vector with an X component, or a proximally directed force vector, can be used to facilitate the return of the valve actuator from the distal position, in which the actuator end is inserted into the valve to deflect the valve leaflets, to the proximal position, as shown in drawing.

The valve leaflets, or both the valve leaflets and the locking device, can create force vectors directed against the nose of the valve actuator to return the valve actuator from a distal position to a proximal position. In other examples, valve parts or portions other than the valve leaflets may exert a proximally directed action to move the valve from a distal position to a proximal position.

In one example, the portion or portion within the catheter hub adjacent the open proximal end may be a Luer cannula, by which is meant a structure formed in accordance with ISO standards for Luer cannulas. The proximal edges of the two valve actuator plunger elements may be retracted from the proximal open end of the catheter hub but positioned within the Luer cannula. Thus, when the Luer cone is inserted into the Luer cannula, the Luer cone can push the two plunger elements in a distal direction, causing the valve actuator to be pushed into the valve to open the valve, such as to distally deflect the valve leaflets and open one or more slots.

The Luer cone can be inserted into the open proximal end of the catheter hub and advance the valve actuator into the valve to open the valve leaflets and fluid communication between the Luer cone and the lumen of the catheter tubing. In practice, the Luer cone may be the tip of a syringe or the pin tip of an IV or IV set attached to an IV bag.

Fluids can be withdrawn or aspirated from the catheter hub in a proximal direction or infused through the catheter tubing in a distal direction. The Luer cone may have a threaded ring to engage the lugs or external threads on the catheter hub to further hold the valve actuator in the distal position when the valve is open.

In one example, the valve actuator is configured to move distally when advanced by a luer cone. The amount or distance that the valve actuator moves distally must be sufficient to allow the actuator end and nose to deflect the valve flaps distally to open the valve slots and thereby open fluid communication between the luer cone and the tube catheter. In the example shown, the driving end of the valve opening device is moved distal to the valve leaflets, and the valve leaflets are compressed between the interior of the catheter hub and the conical surface of the nosepiece, or at least deflected distally by the nosepiece. The valve flaps can be deformed by the conical surface of the nose. In other examples, the driving end is moved a distance no further than the ends of the valve leaflets but still opens the valve leaflets to allow free flow in both the proximal and distal directions.

When the Luer cone is removed, for example, when replacing an IV bag attached to the Luer cone, the distally directed force on the proximal edges of the two plunger elements on the side of the Luer cone is eliminated or stopped, and the Luer cannula is left unoccupied by any external object. This allows the valve actuator to return to its proximal position, now cleared by the luer cone.

In one example, the elasticity of the valve allows the valve leaflets to return to their more relaxed state. This returning action of the valve leaflets and the shape of the valve actuator nose allow the valve leaflets to apply force vectors to the nose, causing movement of the valve actuator from a distal to a proximal position.

The force vectors generated by each of the valve leaflets at the nasal portion of the valve actuator during the returning action of the valve leaflets include a force component that is generally parallel to the longitudinal axis of the catheter hub, also referred to herein as an X-component force vector or a proximally directed force vector. Thus, the X-component force vector generated by the valve leaflets can cause the valve actuator to move from a distal position, in which the actuator end and nose part deflect the valve leaflets distally to open the valve, to a proximal position, in which the drive end and nose part valve flaps no longer deflect.

In some examples, the nose portion of the valve actuator is contoured, such as with distinct lines or curves, by forming recesses in the nose portion with distinct contour lines or curves. One or more surfaces of the contoured nose may then be used to apply pressure to the valve. The valve can be pressed to create multiple compression points. For example, the contoured nosepiece may be structured to compress the valve leaflets or deflect the valve leaflets distally so that the valve leaflets can in turn create force vectors directed toward the nosepiece when the Luer taper is removed and the valve leaflets return to a relaxed state.

The contoured nose portion may also axially compress the valve portion or portions relative to the distal shoulder such that the valve produces an opposing axially restoring force when the luer cone is withdrawn. Thus, the valve itself can push the valve actuator in a proximal direction upon removal of the luer taper when the valve returns back after being compressed by only the contoured nose piece or multiple pinpoint portions of the contoured nose piece.

In one example, the valve actuator may deflect, deform, or displace the valve, such as deflect, deform, or displace the flaps of the valve and other portion or portions of the valve, such as a portion of the skirt protruding from the valve disc. When the valve leaflets and the other part or parts, such as the skirt part, return to their relaxed or non-displaced state, they apply proximally directed forces to the valve actuator to move the valve actuator from a distal position to a proximal position.

In some examples, the interaction between the locking device ramp section and the nose section creates force vectors on the valve opening device nose that include an X-component force vector. For example, the valve actuator may include an elastic band or one or more elastic strips that are compressed, deformed, or displaced by the locking device as the nose portion is advanced by the luer cone into the locking device to transfer the stored energy. Thus, in addition to the restoring force generated by the valve leaflets on the nose of the valve actuator, the interaction between the locking device and the nose of the valve actuator creates a restoring force and promotes proximal movement of the valve actuator from the distal position where the actuator end and nose deflect the valve leaflets into distal direction, to the proximal position, where the driving end and nose no longer deflect the valve leaflets.

In the proximal position, the valve actuator is located within the catheter hub, and the valve flaps generally cover the slots to stop or restrict the flow of fluid proximally and/or distally. In some examples, the nose portion may be provided with a recess and an elastomeric strip or strip is placed into the recess to create a valve actuator with a rigid portion and a more compliant portion. In other examples, the nose portion is molded or inserted into a mold along with an elastomeric strip or tape. An elastomeric strip or band integrated with the nose piece may allow the valve actuator to be pressed against the rigid portion or component of the locking device to produce a return force after removal of the outer luer tip.

Thus, it is understood that objects of the invention include a catheter assembly or needle device comprising a catheter hub with a catheter tube extending in a distal direction, said catheter hub including a body having an outer surface and an inner surface defining an internal cavity. A valve and a valve actuator may be located in the internal cavity. In one example, a locking device having an orifice defining body is located proximal to the valve. The valve leaflets may provide a proximally directed return force to return the valve actuator from a distal position to a proximal position.

Additionally or alternatively, the valve may be compressed, deformed, or axially displaced relative to the distal shoulder and valve, providing an axially directed force against the nose to return the valve actuator when the luer cone is removed. In one example, the locking device may interact with a valve actuator, such as an elastomeric valve actuator portion, when the valve actuator is advanced distally by a luer cone to open valve leaflets, wherein the interaction may generate force vectors including a force vector that extends generally parallel to the longitudinal the axis of the catheter hub to return the valve actuator from the distal position to the proximal position when the Luer cone is removed from the catheter hub.

A valve, such as valve flaps or a valve skirt, can be deflected, displaced, or deformed by a first structure, such as a valve actuator, moving within the valve, without requiring the second structure to be positioned opposite the first structure, although the second structure may optionally be incorporated. For example, valve flaps may be deflected by a valve actuator without a collar or rigid surface located on the opposite side of the valve flaps to stop deflection. Other objects may be deflected, displaced, or deformed without an opposing structure, for example, a leaf spring may be deflected, displaced, or deformed by the action of a valve actuator nose, or a spring ring may expand upon insertion of a conical portion of the nose.

In some examples, the nose portion is spatially separated from the locking device or is not adjacent to the locking device, and the return force is provided only by the valve. The locking device may further provide the function of securing the valve within the catheter hub and preventing the valve from inadvertently proximal displacement and removal from the catheter hub. The catheter hub may include a needle extending through the catheter hub, a valve, a valve actuator, a locking device, and a catheter tubing. The needle may be attached to a needle hub at the proximal end of the needle.

Because the valve actuator can move to a distal position within the valve, such as when a luer cone is pushed to open two or more valve leaflets, and can return to a proximal position when the luer cone is removed to allow the valve leaflets to expand or converge to close the slots, the valve may go through several actuation cycles. In one example, the valve may undergo two or more actuation cycles. For example, the valve may undergo at least two cycles, at least three cycles, at least four cycles, at least five cycles, or more.

In one example, an annular slot or annular channel may be provided on the proximally facing surface of the valve. The annular slot can be moved away from the outer border of the valve. The annular slot may be provided in a first valve portion that is a thicker valve portion than a second valve portion. An annular slot may be provided to receive the distal end of the locking device.

The locking device may be a retaining ring having a distal end that fits into an annular slot. In one example, the distal end of the locking device may be pressed into the annular slot and held there by compression or tension. In other examples, the locking device may be held in the annular slot using adhesive or bonding. In still other examples, the annular slot is an annular channel and does not engage the locking device on either the inner or outer surfaces of the locking device. For example, the locking device may be pressed against the annular channel by its outer surface, but be distant from the annular channel in terms of the inner surface of the locking device. This alternative configuration allows the locking device to press the valve outward against the catheter hub without the need for the annular gap to engage both the inner and outer surfaces of the distal end of the locking device.

The retaining ring may have a wall length between the proximal and distal ends of the retaining body and with a curved portion of the body with a constant wall thickness at the proximal end of the retaining ring. The wall may have an interior portion defining an opening to accommodate the nose of the valve actuator and to provide fluid flow, for example, for flushing.

The wall of the fixation device may be generally cylindrical except at the proximal end. In one example, the proximal end of the retaining ring may have an outwardly curved edge to secure the retaining ring to the inner shoulder of the catheter hub. Once secured to the inner collar, the locking device can help secure the valve from proximal movement. The valve may be secured or prevented from moving distally by positioning the distally facing surface of the valve against the shoulder of the catheter hub.

The locking device and the valve actuator nose portion may be spaced apart at a proximal position of the valve actuator. The gap or distance therebetween provides clearance for the valve actuator to move distally to open the valve, such as to deflect the valve leaflets, before contacting or impacting the locking device. The drive end at the nose of the valve actuator may be located within an opening defined by the locking device, but spaced apart, that is, not in contact with the locking device. The conical surface of the nose can also be spaced away from the locking device. This clearance allows the valve actuator element to move forward in a distal direction before it impacts or contacts the locking device. The driving end may contact the proximally facing surface of the valve. In other examples, the driving end may be slightly distant from the proximally facing surface of the valve.

A Luer cone can be inserted into the open proximal end and the valve actuator can be advanced into the valve to open the valve leaflets and fluid communication between the Luer cone and the lumen of the catheter tubing. The Luer cone may have a threaded ring to engage the lugs or external threads on the catheter hub to further hold the valve actuator in the distal position when the valve is open.

In one example, the valve actuator is configured to move distally as the luer cone advances. The distance that the valve actuator is moved distally must be sufficient to cause the actuator end and nose to deflect the valve flaps distally, open the slots, and thereby open fluid communication between the Luer cone and the catheter tubing. The drive end of the valve actuator may be moved distal to the valve leaflets, wherein the valve leaflets may be compressed or deformed by the conical surface of the nose portion, or at least deflected or deformed distally by the nose portion of the valve actuator. The driving end can move a distance equal to or shorter than the ends of the valve flaps while still opening the valve sufficiently for free flow in both directions.

The curved edge on the locking device may act as a biasing element. Thus, when the nose of the valve actuator is pressed against the curved edge on the proximal end of the locking device, the curved edge is pressed against the nose, such as an elastomeric strip, tape or section built into the nose, and creates a pair of force components or force vectors on the nose of the valve actuator, which includes a force acting generally parallel to the longitudinal axis of the catheter hub. In other examples, the nose portion is spaced from the locking device when the Luer cone contacts the Luer cannula of the catheter hub. The valve in this case may provide the return force necessary to return the valve actuator from a distal position to a proximal position, and the valve actuator may not have a compliant portion or portions at the nose.

When the Luer taper is removed, such as when replacing an IV bag attached to the Luer taper, the distally directed force on the proximal edges of the two plunger elements of the Luer taper is removed or terminated and the Luer cannula is left unoccupied by an external object. This allows the valve actuator to return to its proximal position, now cleared by the luer cone.

In one example, the elasticity of the valve allows the valve leaflets to return to a more relaxed state, such as moving to a proximal position. This returning action of the valve leaflets and the shape of the valve actuator nose allow the valve leaflets to apply force vectors to the nose to cause movement of the valve actuator from a distal position to a proximal position.

Therefore, the subject matter of the invention refers to a catheter assembly or needle device comprising a catheter hub having a catheter tube extending in a distal direction, the catheter hub being included in a housing having an outer surface and an inner surface defining an internal cavity. A valve and a valve actuator may be located in the internal cavity. In one example, a locking device with an orifice defining body is positioned proximal to the valve and locks the valve within the catheter hub.

In one example, the locking device engages with a valve actuator when the valve actuator is advanced distally by a luer cone. In another example, the Luer cone abuts the Luer cannula of the catheter hub before the nose of the valve actuator contacts the locking device. The valve drive is configured to open the valve flaps.

In one example, engagement, deflection, displacement, or compression of the valve leaflets by the valve actuator results in force vectors including a force vector that is directed substantially parallel to the longitudinal axis of the catheter hub and returns the valve actuator from a distal position to a proximal position when the luer cone is removed from catheter bushings.

The locking device may also apply a restoring force to the nose of the valve actuator, such as an area of the nose with a compliant insert, elastic band, or material, to provide additional proximally directed restoring force. In some examples, the locking device may include a structure with elastic characteristics to store energy upon displacement, deformation, or deflection of the valve actuator and subsequently release the stored energy to generate a proximally directed force on the valve actuator to move the valve actuator from a distal position to a proximal position.

As already discussed, moving from a distal to a proximal position or vice versa requires tangible physical movement.

The locking device may further provide the function of locking the valve within the catheter hub and preventing accidental proximal displacement of the valve and its removal from the catheter hub. The catheter hub may include a needle extending through the catheter hub, a valve, a valve actuator, a locking device, and a catheter tubing. The needle may be attached to a needle hub at the proximal end of the needle.

Because the valve actuator can move to a distal position within the valve, such as when pushed by a luer cone to open two or more valve leaflets, and can return to a proximal position when the luer cone is removed to allow the valve leaflets to relax or converge to close in the slots , the valve may go through several actuation cycles. In one example, the valve may undergo two or more actuation cycles. For example, the valve may undergo at least two actuation cycles, at least three actuation cycles, at least four actuation cycles, at least five actuation cycles, or more. Each actuation cycle can be specified as a movement of the valve actuator into the valve to deflect the valve flaps and a movement away from the valve.

In another example, the locking device may be a retaining ring having a distal end with an outwardly curved edge forming a flange for abutment or contact with a proximally facing surface of the valve, and a wall or body tapering from a first dimension to a second, larger dimension in a proximal direction. Thus, the wall of the present embodiment may resemble a ramp, with the ramp portion being tall at a distal location and tapering as it moves proximally.

The proximal end of the locking device may include a proximal edge that may be sized to fit or press against the inner collar of the catheter hub. By being positioned against the inner shoulder, the locking device can help secure the valve from moving proximally. In an alternative embodiment, there is no need for a collar to secure the locking device in the internal cavity if there is little interference between the proximal end and/or distal end of the locking device and the inner diameter of the catheter hub. The valve may be secured or restrained from distal movement by positioning against the collar with the distally facing surface of the valve.

The locking device and the valve actuator nose portion may be spaced apart in a proximal position of the valve actuator. The gap between them provides clearance for the valve actuator to move distally to open the valve, for example to deflect the valve leaflets, before closing the gap, contacting or striking the locking device.

In the proximal position of the valve actuator, the drive end at the nose of the valve actuator may be located within the opening defined by the locking device, but spaced apart, that is, not in contact with the locking device. The conical surface of the nose can also be separated from the locking device. This distance or clearance allows the actuator valve element to move forward in a distal direction before it collides with or contacts the locking device. The driving end of the actuating valve may be in contact with a proximally facing surface of the valve. In other examples, the driving end may be slightly distant from the proximally facing surface of the valve.

A luer cone can be inserted into the open proximal end and the valve actuator can be advanced into the valve to open the valve leaflets and fluid communication between the luer cone and the lumen of the catheter tubing.

In one example, the valve actuator is configured to move distally as the luer cone advances. The distance that the valve actuator is moved distally must be sufficient to allow the actuator end and nose portion to deflect the valve flaps distally to open the slots and thereby open fluid communication between the Luer cone and the catheter tubing. In one example, the driving end of the valve actuator is moved distal to the valve leaflets, wherein the valve leaflets are compressed or deformed between the interior of the catheter hub and the conical surface of the nose, or the valve leaflets are deflected distally by the nose of the valve actuator.

In some examples, the nose portion of the valve actuator is contoured, such as with distinct lines or curves, by forming recesses in the nose portion with distinct contour lines or curves. One or more surfaces of the contoured nose piece can then be used to press against the valve and recoil the valve to push the contoured nose piece in a proximal direction to return the valve actuator to the proximal position. For example, one or more contoured surfaces may axially compress, deform, or displace the valve relative to the distal shoulder to create stored energy such that the valve provides an axially directed return force upon removal of the outer luer tip. In some examples, the drive end moves a distance equal to or shorter than the ends of the valve flaps, but still opens the valve sufficiently to allow free flow in both directions.

In one example, the locking device ramp acts as a biasing element. For example, when the nose is pressed against the ramp of the locking device by a luer cone, the locking device exerts an opposing biasing force on the nose of the actuator, such as a compliant portion located on the nose. Thus, when the nosepiece is pressed against the ramp, the locking device ramp produces a pair of force components or force vectors on the nosepiece, which includes a force acting generally parallel to the longitudinal axis of the catheter hub. In some examples, the nose portion is away from the locking device when the Luer cone contacts the Luer cannula of the catheter hub.

When the Luer cone is removed, for example, when replacing an IV bag attached to the Luer cone, the action of the distal force on the proximal edges of the two plunger elements on the side of the Luer cone disappears or stops, and the Luer cannula is not occupied by any external object. This allows the valve actuator to return to its proximal position, now cleared by the luer cone. In one example, the elasticity of the valve allows the valve leaflets to return to a more relaxed state.

This returning action of the valve leaflets and the shape of the valve actuator nose allow the valve leaflets to apply force vectors to the nose to move the valve actuator from a distal to a proximal position. In addition, the ramp structure of the locking device may exert a restoring effect on the nose portion, such as a plastic portion located on the nose portion, to move the valve actuator in a proximal direction to return the valve actuator to the proximal position.

Therefore, by subject matter of the invention is meant a catheter assembly or needle device comprising a catheter hub having a catheter tube extending distally, a needle attached to the needle hub, and a needle extending through the catheter hub and the catheter tube. The catheter hub is a body having an outer surface and an inner surface defining an internal cavity.

A valve and a valve actuator may be located in the internal cavity. In one example, a locking device with an orifice defining body is positioned proximal to the valve and locks the valve into the catheter hub. The locking device may frictionally interact with the valve actuator as the valve actuator is advanced distally by the Luer cone to open the valve leaflets, the frictional interaction providing force vectors including a vector that is directed substantially parallel to the longitudinal axis of the catheter hub to return the valve actuator from the distal position to proximal position when the Luer cone is removed from the catheter hub.

The locking device may further provide the function of securing the valve within the catheter hub and preventing the valve from accidental proximal displacement causing it to pop out of the catheter hub and not providing a return force to drive the valve.

In one example, the retaining ring has a ring body with a first or distal end and a second or proximal end. The ring body may have a generally constant outer dimension along the length of the ring body and may be generally cylindrical. Internally, the annular body may have a smaller internal diameter at the distal end than an internal diameter at the proximal end, and a wall thickness that decreases in size from the distal end to the proximal end.

The inner surface of the annular body may define an opening configured to accommodate a valve actuator. A fluid flow may pass through the opening. The locking device bore may compress or displace the nose of the valve actuator to create a pair of force components as discussed previously. In another example, the locking device is sized and shaped to be positioned away from the nose when the Luer cone abuts the Luer cannula of the catheter hub. In one example, the fixation device is formed from a medical grade plastic material. In other examples, the fixation device may be formed from a medical grade elastomeric material or a thermoplastic elastomeric (TPE) material. Alternatively, the locking device may be manufactured from a metallic material, for example by stamping and bending or machining.

The cross-section of the ring body may be in the form of a ramp or an inclined surface on the inner surface of the ring body. In addition, the inclined surface may have a constant slope. In other examples, the slope of the inclined surface is not constant. For example, there may be one or more irregularities or inflection points that result in a contour that is not straight. The contour, whether permanently inclined or not, may be selected to exert compression, displacement, or contact interaction with the valve actuator nose, such as the plastic portion or portions of the nose, when the valve actuator is pushed toward the locking device. Compression, displacement, or contact interaction with the valve actuator can be configured to produce force vectors that include a force substantially parallel to the longitudinal axis of the valve actuator. This in turn helps the valve actuator move from a distal to a proximal position.

In one example, the proximally facing surface of the valve provided herein may have an annular slot or annular groove for receiving the distal end of the locking device. In some examples, the annular slot may be an annular channel with a width that does not span both the inner and outer surfaces of the distal end of the locking device. The fixation device may be made of a thin-walled cylinder, such as a metal or plastic material, with the proximal end being curved outward and ending in a curved edge, like a rounded corner.

An inner surface of the annular body of the locking device may define an opening configured to receive a valve actuator and compress or displace a valve actuator nose portion, such as a plastic portion or portions of the nose portion, to apply a pair of force components, as previously discussed. The rounded corner of the curved edge is configured to compress the nose of the actuator and apply a pair of component forces. In another example, the locking device is sized and shaped to be positioned away from the nose when the Luer cone abuts the Luer cannula of the catheter hub.

The curved edge of the locking device may have an outer diameter, wherein the outer diameter of the curved edge is smaller than the outer diameter of the valve. Depending on the structure of the inner cavity of the catheter hub, the size of the curved edge can be adjusted so that when installed inside the catheter hub, the curved edge abuts or contacts the collar inside the catheter hub to secure the retaining ring in the inner cavity of the catheter hub.

In one example, the locking device ring body has a distal end with a curved edge defining a flange that has a generally flat wall surface for abutting a surface of the valve, such as a proximally facing surface of the valve. The ring body of the locking device may have a generally constant wall thickness that tapers outward from a first diameter at the distal end, immediately proximal to the flange, to a second larger diameter at the proximal end, which has a proximal edge for abutment or contact with a collar within the catheter hub and thus thereby holding the fixing device inside the catheter hub.

The wall surface may have an inclined surface, resembling a ramp. The inner surface of the ring body of the locking device defines an opening, wherein the opening is configured to accommodate a valve drive. The opening may compress or displace the valve actuator nose, particularly the portion or portions of the nose including an elastomeric strip, tape, or material, to transmit a pair of force components to the valve actuator. In another example, the locking device is sized and shaped to be positioned away from the nose when the Luer cone is adjacent to the Luer cannula of the catheter hub.

The present catheter assembly or catheter device may employ a spring with beveled helical coils. A canted coil spring has a plurality of interconnected coils that are generally canted along one direction. The spring may be made of a metallic material. A beveled coil spring may have an extended configuration with two free ends. A canted coil spring may also have a ring configuration with two ends connected along the length of the spring. Canted coil springs are well known in the spring art, and canted coil spring coils are known to be flexible or compressible in a radial direction relative to the centerline of the ring.

A spring with a beveled helix in a spring ring configuration can be used as a locking device. A spring with a beveled coil as a locking device can be abutted against the proximal surface of the valve and against a collar in the interior of the catheter hub to secure the spring ring in the interior of the hub.

The proximally facing surface of the valve may have a recess for mating with the distal arc of the conical coil spring. In the proximal position of the valve actuator, the coils of the conical helix spring contact both the inner surface of the catheter and/or valve sleeve and the nose of the valve actuator. In other examples, the coils may be removed from the surface of the nose, such as not contacting the nose in the proximal position of the valve actuator.

When the luer cone of a medical instrument is inserted into the catheter hub to open or deflect the valve leaflets, a canted coil spring is compressed by the nose of the valve actuator. Each coil of the plurality of coil spring coils can be compressed by the nose of the valve actuator as the coils of the coil spring are compressed when compressed in the radial direction of the spring ring centerline.

The compression of the coils creates force vectors on the nose, as the coils tend to unclench or return back. The force vectors generated at the nose portion include a force that is generally parallel to the longitudinal axis of the valve being opened. The distally directed axial force vector is directed against the proximal surface of the valve if the coils are compressed on one side by the valve, or against the inside of the catheter hub if the coils are compressed on one side by the catheter hub, and the proximally directed force vector is directed against the valve actuator.

When the luer cone is removed, the spring coils relax and press against the nose, creating a pair of force components, including a proximally directed axial force vector. This in turn may help move the valve actuator proximally to return the valve actuator to the proximal position and allow the valve to return to the closed position. The forces generated by the snap ring 244 to move the valve actuator after the luer cone is removed may be in addition to the forces generated by the valve flaps returning to the open or closed state to close the valve slots after the luer cone is removed. Proximally directed forces may move the valve actuator from a distal position back to a proximal position within the catheter hub after the medical instrument pin is disconnected from the catheter hub.

In another example, the valve may be provided with an integral or assembled locking device. The integrated or assembled retaining device may be a retaining skirt portion having a triangular cross-section. The additional outer surface area of the skirt or retaining device may help further retain the valve in the catheter hub when the needle is withdrawn and when the valve actuator is pressed with the Luer cone to open the valve.

The skirt portion may be sized such that when the valve actuator is pushed distally by the luer cone, the triangular section of the skirt may be compressed, deformed, or displaced by the conical nose portion and the inside of the catheter hub. Therefore, when a pin tip, such as a syringe Luer cone or an IV set tip, is removed, the triangular skirt can expand, creating a pair of force components at the nose that includes a proximally directed axial force vector. This in turn helps push the valve actuator in a proximal direction to return the valve actuator to its proximal position from the distal position and allow the valve to return to the closed position.

In yet another example, a locking device in accordance with aspects of the invention has a ring body with a distal end with a curved edge defining a flange that has a generally flat wall surface for abutting a valve surface. The ring body has a generally constant wall thickness that tapers back from a first diameter at the distal end, immediately proximal to the flange, to a second, larger diameter at the proximal end, which has a proximal edge and is configured to contact or contact a collar within the catheter hub for holding the fixation device inside the catheter hub. In an alternative embodiment, the collar may be eliminated and the proximal edge may form a friction fit with the inner edge of the catheter hub.

The wall surface of the ring body may have an inclined surface resembling a ramp. An inner surface of the locking device ring body defines an opening configured to receive a valve actuator and compress or displace the valve actuator nose to create a pair of force components as previously discussed.

In the present embodiment, two or more leaf springs, such as three to eight leaf springs, may be provided as part of the holding ring for holding the valve. In another example, only one leaf spring may be provided. Leaf springs can be formed by forming a symmetrical three-sided cutout on the ring body and bending the cutout inward to form a leaf spring. However, the cutouts may not be three-sided, such as a partial circle cutout, or the cutouts may be asymmetrical or multi-sided, with more than three sides. To form leaf springs, any number of cutouts on the retaining device can be used to create force vectors on the valve actuator, with three-way cutouts being preferred. After the one or more cutouts are formed, the bending direction of the cutouts to form the leaf spring(s) is the direction that allows the one or more leaf springs to contact the nose of the valve actuator.

The leaf springs may be sized such that when the valve actuator is pushed distally by the luer cone, the leaf springs are deformed, deflected, or displaced by the conical nose of the valve actuator. Therefore, when the pin tip is removed, the leaf springs expand or decompress to create a pair of force components at the nose that includes an axial force vector in the proximal direction.

The biasing forces of the leaf springs help push the valve actuator proximally to return it from the distal position to the proximal position and allow the valve to return to the closed position. The forces of the leaf springs can be in addition to the forces generated by the valve flaps returning to the open or closed position to close the valve slots after the luer cone is removed. In this embodiment with one or more leaf springs, the nose portion may be rigid without any plastic portion or portions that may be optionally included.

In one embodiment, the locking device may be a retaining ring and be provided with integral or separately formed flexible flaps or leaf springs. The locking device can be implemented in the form of an eye in which one or more leaf springs extend from the flange.

The lug-type locking device may be used with the catheter assemblies described herein. The locking device has a flange as a ring body, the flange having an outer diameter (OD) and an inner diameter (ID) defining a hole. The flange may have a thickness that may be the thickness of the metal sheet used to form the eye. The thickness of the flange and the thickness of the leaf springs can be the same or approximately the same. If the flange and leaf springs are formed from the same metal sheet, the thickness of the flange and the thickness of each of the leaf springs can be the same, within the tolerance of the thickness of the metal sheet.

In the lug embodiment, there is no cylindrical or elongated hollow body protruding from the flange. Instead, two or more leaf springs, such as three to eight leaf springs or at least one leaf spring, may extend directly from the flange. The drawings show four leaf springs integrated with a flange, with each leaf spring positioned at approximately 90 degrees with respect to the adjacent leaf spring. However, there may be three leaf springs or another number. Leaf springs can be spaced equally apart along the contour of the flange. Leaf springs help center the valve actuator relative to the slots in the valve.

The leaf springs may extend from the inner diameter (ID) of the flange in a proximal direction, and each leaf spring may terminate at a proximal end edge. The proximal end edge of each of the leaf springs may be flat or radius.

The leaf springs may be spaced equally or approximately equally spaced along the flange ID. The leaf springs may extend directly across the ID flange boundary or extend away from it, for example by bending to form a leaf spring or from slots or cutouts used to create and recess each leaf spring from the ID flange, for example.

Each leaf spring may have a width and length sufficient to produce a component of force at the nose of the valve actuator, and the leaf springs collectively may produce a proximally directed force that can move the valve actuator from a distal position to a proximal position upon removal of the luer cone.

A pair of internal cutouts or slots may be provided on the flange ID and on each side edge of each leaf spring to allow each leaf spring to have a bend whose radius is recessed from the flange ID. In other examples, the pair of internal cutouts on the ID flange may not be provided, and each bend in the proximal direction may have an exact shape, that is, a right angle. In an alternative design, the bend radius may extend slightly inward from the ID flange when there are no or insufficient internal recesses.

The lug-type locking ring may be configured to lock the valve within the catheter hub, like other locking rings discussed herein. The valve may be held by a distally facing surface by an inner shoulder and by a proximally facing surface by a retaining ring flange which may be held by an inner shoulder by a proximal side of the flange. Thus, the valve may be secured or held within the catheter hub on the distal side by a collar and on the proximal side by a retaining device, such as a retaining device flange.

In the proximal position of the valve actuator, the driving end of the valve actuator may contact the proximally facing surface of the valve or may be distant from the proximally facing surface of the valve by a relatively short distance. Regardless of whether there is contact or no contact between the valve actuator and the valve at the proximal position of the valve actuator, the nose portion can be positioned within the boundary defined by the leaf springs but not touch the leaf springs. For example, in the proximal position of the valve actuator, the nose may be spaced away from both the leaf springs and the flange. This distance allows the valve actuator to move distally into the valve to open the valve leaflets before the nose contacts the leaf springs.

In one example, the flange of the locking device may include one or more relief shapes or cutouts on the outer diameter of the flange. The raised shapes can reduce the interaction between the outer diameter of the flange and the inner opening of the catheter hub during installation of the locking device into the catheter hub. For example, raised shapes on the outer diameter allow the outer diameter of the flange to be more flexible and the sections formed by the cutouts to bend independently as needed.

Each cut on the outer diameter of the flange can be formed as a straight cut through two points on the arc of the outer diameter of the flange. In some examples, each cutout may be in the form of a curve, a curve and at least one straight cutout, or a complex curved cutout. In one example, a cutout may be provided on each leaf spring on the outer diameter of the flange. In other examples, the cutouts may not be located in accordance with the arrangement of the leaf springs, such as not directly on the portion OD at the same location ID as the leaf spring. In other examples, there may be more or less cutouts than the number of leaf springs.

In the distal position of the valve actuator, the nose portion protrudes through the valve slots to deflect the valve leaflets distally and may compress the valve leaflets between the nose portion and the inner surface of the catheter hub, or the valve leaflets may be deflected or deformed distally by the action of the valve leaflet nose without being compressed against the inner surface. surface.

The driving end of the valve actuator may be distal to the distally deviated valve leaflets. In other examples, the driving end may be located at approximately the same axial position as the deflected valve leaflets, or proximal to the valve leaflets, while still allowing fluid to flow through the valve in a proximal or distal direction.

The leaf springs may be positioned on the flange such that when the valve actuator is pushed distally by the luer cone, the leaf springs are deflected radially outward by the conical nose of the valve actuator. In one example, the proximal edge of each leaf spring is spaced from the interior of the catheter hub when deflected by the nose of the valve actuator. In another example, the proximal edge may contact the inner surface of the catheter hub.

The deflected leaf springs and deflected valve leaflets create stored energy, which can then push against the nose of the valve actuator to move the valve actuator proximally after the luer cone is withdrawn to release the stored energy.

When the pin tip is removed from the catheter hub, the leaf springs can be compressed or decompressed to create a pair of force components at the tip that includes an axial force vector in the proximal direction. The displacement forces of the leaf springs may help push the valve actuator in a proximal direction to return the valve actuator from the distal position to the proximal position and allow the valve to return to the closed position.

The forces applied by the retainer leaf springs to the valve actuator may be in addition to the forces applied by the valve flaps to the valve actuator when the valve flaps are returned to the open or closed position to close the valve slots after removal of the luer cone. In an embodiment with one or more leaf springs on the retaining device, the valve actuator nose portion may be rigid with no plastic portion or portions that may be included as desired.

Because the valve actuator can move to a distal position in the valve, such as when the luer cone is depressed to open two or more valve leaflets, and can return to a proximal position when the luer cone is removed to allow the valve leaflets to open or close slots, the valve can pass several actuation cycles. In one example, the valve may undergo two or more actuation cycles. For example, the valve may undergo at least three cycles, at least four cycles, at least five cycles, or more. Each actuation cycle may include movement into the valve by the valve actuator to deflect the valve flaps and movement away from the valve.

In an alternative lug embodiment, the flange of the locking device or ring, which may have an ID, OD, and thickness, may have an arc or bend in cross-section. Thus, the distal facing surface and the proximally facing surface of the flange have an arcuate or curved shape. In one example, the distal facing surface of the flange has a convex shape and the proximally facing surface of the flange has a concave shape. The curved flange can facilitate installation in the direction of installation of the fixing device, and the arc-shaped shape of the flange along the section allows the OD flange to smoothly fit against the inner surface during installation. The curved section can also strengthen the flange against deformation during installation.

Raised shapes or cutouts on the outer diameter of the lug flange may not be associated with leaf springs. Using the clock hand for comparison, the leaf springs can be located at the 2, 4, 8, and 10 o'clock positions on the flange ID, and the cutouts can be located at the 3, 6, 9, and 12 o'clock positions on the flange OD. In other examples, the location of the leaf springs along the flange ID and the location of the cutouts along the flange OD may vary. In addition, the number of leaf springs and cutouts can be different, for example two leaf springs and three cutouts or three leaf springs and two cutouts.

Due to the curved or arcuate cross-section of the alternative eyelet embodiment, the leaf springs can be bent, for example, to form a leaf spring with a free end in the proximal direction, without the need to include cutouts or slots at the flange ID. However, slots or notches may be provided to assist or facilitate bending of the projections to form leaf springs.

In yet another example, the catheter assembly may use a retention device that is a retention ring made of an elastomeric material. For example, the locking device may be made of an elastomeric material, such as an O-ring, that can store energy when displaced or deformed. Thus, when the elastomeric material releases its stored energy, it can provide a proximally directed force to the valve actuator to move the valve actuator from a distal position to a proximal position.

In one example, an elastomeric material, which may be an O-ring, may be compressed between the nose of the valve actuator and the inner wall of the catheter hub at the distal position of the valve actuator. The locking device may have a sealing ring structure with various possible cross-sections, such as round, oval or polygonal, for example square, rectangular or triangular in shape. The locking device may be an elastomeric ring with a circular cross-section. The locking device may be formed separately from the valve and used in conjunction with the valve to secure the valve within the interior of the catheter hub.

A valve used with a catheter hub may be secured or supported distally by an internal collar within the catheter hub, which may prevent or limit axial distal movement of the outer perimeter of the valve while still allowing the valve leaflets to deflect distally when pressed by the valve actuator. The valve may be secured or supported on the proximal side by a locking ring or an elastomeric ring of the present embodiment. The elastomeric ring may be adjacent to an internal collar within the catheter hub to secure the elastomeric ring, and therefore the valve, from proximal displacement.

The locking device and the valve actuator nose portion may be spaced apart in a proximal position of the valve actuator. The gap or distance therebetween provides clearance for the valve actuator to move distally to open the valve, such as to deflect the valve flaps, before closing the gap by contacting or pushing the locking device with the valve actuator.

The drive end at the nose of the valve actuator may be located within the hole defined by the locking device, but at a distance from the locking device, that is, not in contact with it. The conical surface of the nose can also be removed from the locking device. This distance or clearance allows the valve actuator to move forward in a distal direction before it engages or contacts the locking device. The driving end of the valve actuator may be in contact with a proximally facing surface of the valve. In other examples, the driving end may be slightly away from the proximally facing surface of the valve.

The Luer cone used herein may have a threaded ring to engage lugs or external threads on the catheter hub to maintain the valve actuator in a distal position to open the valve.

In one example, the valve actuator is configured to move distally as the luer cone advances. The distance that the valve actuator is moved distally must be sufficient to cause the actuator end and nose to deflect the valve flaps distally to open the slots, thereby opening fluid communication between the Luer cone and the catheter tubing.

In one example, the driving end of the valve actuator is moved distal to the valve leaflets, and the valve leaflets may be compressed between the interior of the catheter hub and the conical surface of the nose piece, or the valve leaflets are deflected or deformed distally by the nose portion of the valve actuator without being compressed. In some examples, the drive end may move a distance equal to or shorter than the ends of the valve flaps, but still open the valve sufficiently for free flow in both directions.

In one example, the elastomeric ring of the locking device acts as a biasing element. For example, when the nose piece is pressed against the locking device and compresses or displaces the locking device between the nose piece and the inner surface of the catheter hub, the stored energy is transferred to the elastomeric material, which may be an O-ring, and can apply a biasing force in the opposite direction to the nose piece of the actuator. Thus, when the nosepiece is pressed against the elastomeric ring, the elastomeric ring may apply a pair of component forces or force vectors to the nosepiece, which may include a force acting generally parallel to the longitudinal axis of the catheter hub in a proximal direction.

When the Luer cone is removed, such as when replacing an IV bag attached to the Luer cone, the distal force exerted on the proximal edges of the two Luer cone plunger elements ceases and the Luer cannula is unoccupied by any external object. This allows the valve actuator to return to its proximal position, now cleared by the luer cone.

In one example, the elasticity of the valve allows the valve flaps to return to a more relaxed state, for example, to move to close slots or close the valve disk. This opposition of the valve leaflets and the shape of the valve actuator nose allow the valve leaflets to apply force vectors to the nose to cause movement of the valve actuator from a distal position to a proximal position. In addition, as discussed above, the elasticity of the locking device can apply a restoring force to the nose to move the valve actuator in a proximal direction.

Thus, it is understood that objects of the invention include a catheter assembly or needle device comprising a catheter hub with a catheter tubing extending distally, a needle attached to the needle hub, and a needle extending through the catheter hub and the catheter tubing. The catheter hub may include a body having an outer surface and an inner surface defining an internal cavity. A valve and a valve actuator may be located in the internal cavity. In one example, a locking device with an orifice defining body may be positioned proximal to the valve and lock the valve into the catheter hub.

The locking device may provide interaction, i.e. displace the valve actuator, or conversely, displace with the valve actuator, when the valve actuator is advanced distally by the Luer taper to open the valve leaflets, and when the interference fit provides force vectors including a vector that is directed generally parallel to the longitudinal axis of the catheter hub in the proximal direction to return the valve actuator from the distal position to the proximal position when the Luer cone is removed from the catheter hub.

The locking device may further provide the function of locking the valve within the catheter hub and preventing inadvertent proximal displacement of the valve and its extrusion from the catheter hub. If the valve on the other side pops out of the inside of the catheter hub, the valve may not close properly and blood will leak. The locking device may be an elastomeric material. In a preferred embodiment, the material has a hardness between 30 and 70 Shore A. It may also have a Shore A hardness below 30 or above 70. In one example, the elastomeric material is an O-ring. In a specific example, the sealing ring may have a circular cross-section.

Because the valve actuator can move to a distal position in the valve, such as when the luer cone is depressed to open two or more valve leaflets, and can return to a proximal position when the luer cone is removed to allow the valve leaflets to open or close the slots, the valve can go through several activation cycles. In one example, the valve may undergo two or more actuation cycles. For example, the valve may undergo at least three cycles, at least four cycles, at least five cycles, or more. Each actuation cycle may include movement of the valve actuator into the valve to deflect the valve leaflets and movement away from the valve to close the leaflets.

In another embodiment of the catheter assembly, the elastomeric material, which may be an O-ring, may have a generally square or polygonal cross-section.

In yet another embodiment, in accordance with embodiments of the invention, the valve is provided with a one-piece or composite locking device. In one example, the one-piece or multiple retention device may be a retaining skirt portion formed with the valve disk. The skirt portion may have a generally constant thickness and a proximal end surface that is sized to abut or contact the inner shoulder of the catheter hub to secure the valve within the catheter hub from proximal movement. The proximal end surface of the skirt portion may be of sufficient thickness such that a portion of the skirt portion is exposed radially from the inner flange. This open portion of the skirt portion may allow or provide a target for the valve actuator to press upon to compress, deform, or displace the skirt portion.

The valve may be a valve disc integrated with a skirt. In one example, the valve disc and skirt portion are made separately. The skirt portion can be viewed as a generally cylindrical length having an open proximal end. The valve disk may have a plurality of slots or slotted valve disk portions defining a plurality of valve blades. In one example, the axial wall thickness of the valve disc may be generally constant, without separate first portions and second portions, as shown in the figure and elsewhere herein. However, separate first portions and second portions may be included within a valve having a valve disk and a skirt portion.

In one embodiment, instead of installing a generally constant thickness along the length of the skirt portion, it is possible to install the skirt portion with a ramp-shaped surface in section. For example, a disc valve may have separate first and second portions and may have a ramp-shaped skirt portion.

In an alternative embodiment, the valve actuator may have a body consisting of a nose, two plunger elements, two protrusions, and two stabilizing elements, like other valve actuators described herein. In the present alternative embodiment of the invention, a transition portion is provided proximal to the bow. The transition portion may include a pair of drive beads, each of which has a stop edge. The two actuator flanges may be spaced apart and the two thrust edges may be located at approximately the same axial point or location on the valve actuator, on opposite sides of the nose, to push into the valve at approximately the same time, when the valve actuator is advanced by the luer cone.

Each drive shoulder may include an inclined or beveled surface extending proximally from the abutment edge. Each inclined surface can have a constant slope or a complex slope. Two actuator collars may be located adjacent to the seating portion of the valve actuator transition portion. In rare cases, the valve actuator body may be provided with raised edges or ribs to improve stability and/or strength.

The outer diameter (OD) at the landing site may be generally constant. In one example, the length of the landing portion may have the same outer diameter along its entire length. In other examples there may be a slight increasing slope or a small decreasing slope. An inclined surface on the seating portion may be practiced as long as the seating portion does not abut or interfere with the skirt portion and/or weaken the transition portion, rendering it inoperable as a valve actuator. The hole in the nose and seat may have a generally constant internal diameter (ID).

Distal to the landing part, on the outer side, the nose part may have a generally frustoconical structure. The conical surface of the nose may allow the valve leaflets to apply a pair of force components, which may include a proximally directed force, to return the valve actuator to its proximal position after removal of the Luer cone.

The two contacting edges of the two actuator beads may be pressed against the proximal surface of the valve skirt as a result of the luer cone pushing the valve actuator distally into the valve. Overlapping surfaces of the skirt and actuator shoulder may indicate contact interaction or compression of the skirt between the distal shoulder of the catheter hub and the mating edges of the valve actuator. Thus, when the valve is opened by the valve actuator, the valve flaps are compressed between the nose of the valve actuator and the inner surface of the catheter hub or are deflected or deformed distally by the nose of the valve actuator, and the flaps are compressed or deformed between the distal shoulder of the catheter hub and the two mating edges of the valve actuator. .

In some examples, two drive shoulders with chamfered surfaces and mating edges may be omitted or modified. For example, the nose portion may extend directly to a stepped bead in a transition section without a chamfered bead. Without chamfered beads, the mating surfaces on stepped beads can compress the skirt portion. In other examples, the beveled beads may have a different shape, such as being generally square or having square surfaces without a sloped surface such that the mating edges are at approximately the same height as the beads themselves. In other words, mating edges without beveled shoulders may be provided on the two sides of the valve actuator nose.

In applications where abutting edges and beads with tapered surfaces are not used, the end surfaces of the two stepped beads may compress the skirt portion. The size and shape of the stepped bead and nose can be adjusted to compress the skirt when the tapered beads are eliminated. When using an alternative valve actuator without tapered shoulders, the mating edges of the two stepped shoulders can be directly pressed against the proximal end surface of the valve.

Compression, deflection, deformation, or displacement of various surfaces or parts of the valve when actuated by the valve actuator can create stored energy in the valve. When the Luer cone is withdrawn from the Luer cannula of the catheter hub, the stored energy can be released as the valve leaflets and skirt return to a more relaxed state. Therefore, the valve flaps can apply a proximal force to the nose portion and the skirt portion can apply a proximal force to the two mating edges to move the valve actuator from a distal position to a proximal position.

Because the valve actuator can move to a distal position in the valve, such as when pushed by a luer cone to open two or more valve leaflets, and the valve actuator can return to a proximal position when the luer cone is removed to allow the valve leaflets and skirt to relax or close the slots , the valve may go through several actuation cycles. In one example, the valve may undergo two or more actuation cycles. For example, the valve may undergo at least three cycles, at least four cycles, at least five cycles, or more. Each actuation cycle may include movement of the valve actuator into the valve to deflect the valve flaps and movement away from the valve.

A valve, such as flaps or a valve skirt, can be deflected, displaced, or deformed by a first structure, such as a valve actuator, moving within the valve, without requiring the second structure to be positioned opposite the first structure, although the second structure may be integral if desired. For example, the valve leaflets may be deflected by the valve actuator as the valve actuator moves distally. Therefore, the valve leaflets are deflected distally by the valve actuator with or without a collar or any rigid surface located on the distal side of the valve leaflets. In the presence of a shoulder or hard surface, the valve leaflets can still be deflected distally by the valve actuator and can be compressed between the nose and the shoulder or hard surface. Other objects may be deflected, displaced or deformed without an opposing structure, for example, a leaf spring may be deflected, displaced or deformed by the action of the nose section of a valve actuator, or a spring C-ring or helix may expand upon insertion of the conical portion of the nose section.

It is understood that objects of the invention may include a catheter assembly or needle device including a catheter hub with a catheter tube extending in a distal direction, the catheter hub including a body having an outer surface and an inner surface defining an internal cavity. A valve and a valve actuator may be located in the internal cavity. In one example, the locking device may have a body defining an opening located within the catheter hub and proximal to the valve. In one example, the locking device may be integrally formed with the valve and be a skirt portion. For example, the valve disc may be integral with a valve skirt or skirt portion, wherein the valve skirt may act as a locking device to retain the valve disc within the catheter hub.

The valve leaflets can produce a proximally directed restoring force to return the valve actuator from a distal to a proximal position. In addition, the valve actuator may include one or more mating edges to compress, deform or displace the skirt portion in an axial direction relative to the distal shoulder of the catheter hub. In other words, the valve skirt or skirt portion may have a length, and the valve actuator may compress or deform the valve skirt while driving the valve actuator to a distal position to open the valve and reduce the length of the valve skirt from a first length to a shorter second length. When the skirt portion is reduced in length by the valve actuator, the skirt portion receives stored energy. Therefore, the skirt portion may apply an axially directed force in a proximal direction to the valve actuator when the stored energy is released, for example, to one or more abutment edges of the valve actuator to return the valve actuator to the proximal position after the luer cone is withdrawn.

In one example, the locking device may contact a valve actuator, such as an elastomeric portion of the valve actuator, when the valve actuator is pushed distally by a luer cone to open the valve leaflets, for example, to deflect the valve leaflets distally by the nose, and where the deflection may provide force vectors including a force vector that is directed generally parallel to the longitudinal axis of the catheter hub in a proximal direction to return the valve actuator from a distal position to a proximal position when the Luer cone is removed from the catheter hub. In one example, contact interaction, displacement, deflection, or compression results in energy being stored in the valve skirt. The stored energy may be released to force one or more valve actuator abutment surfaces in a proximal axial direction.

The valve actuator may have multiple surfaces, such as a nose and one or more thrust lips, to deform the valve at multiple distinct locations on the valve to supply stored energy to the valve. The deformable valve surfaces may include valve flaps and other valve surfaces other than valve flaps. For example, in addition to the valve flaps, the skirt portion may be axially compressed when the valve is opened.

The catheter hub may include a needle extending through the catheter hub, a valve, a valve actuator, a locking device, and a catheter tubing. The needle may be connected to a needle hub at the proximal end of the needle.

In yet another embodiment, the needle assembly or catheter assembly, catheter hub, catheter tubing, valve, valve actuator, and locking device may be similar to those shown and described elsewhere with some exceptions. In the present embodiment, an annular slot or an annular channel with increased clearance may be provided on the proximally facing surface of the valve to receive the distal end of the locking device. That is, the increased gap of the annular channel of the present embodiment can contact the outer surface of the annular body of the locking ring, but not the inner surface of the annular body due to the increased gap. The ring body may also contact an end or distal surface of the annular channel to control or set the depth of the annular channel relative to the ring body. This configuration allows the locking device to retain the valve in the interior of the catheter hub while relaxing the tolerances or simplifying the manufacturing requirements for forming or creating the annular channel, since the inner surface of the annular body does not have to be captured by the annular channel. The channel is also easier to form using standard molding methods than to partially cut the valve disc.

The annular body of the retaining ring may have a wall extending from a proximal end to a distal end generally with a constant wall thickness and a curved body portion at the proximal end of the retaining ring. The ring body wall may have an interior portion defining an opening for receiving the valve actuator nose portion.

The wall of the fixation device may be generally cylindrical, except for a curved body portion at the proximal end. In one example, the proximal end of the locking ring may have an outwardly curved edge to secure the locking ring to an additional inner collar of the catheter hub. Once positioned against the inner shoulder, the locking device can help secure the valve from proximal movement. The valve may be secured or prevented from moving distally by positioning the distal facing surface of the valve against the collar of the catheter hub. In some examples, the curved edge of the retaining ring is adjacent to the inner surface of the hub of the beadless catheter.

The locking device may be provided by one or more leaf springs. Four leaf springs may be provided with a detent device and spaced equally apart at approximately the 2, 6, 8 and 10 o'clock positions. However, the leaf springs can be located at different positions in the arc of the ring body. In one example, a leaf spring may be formed by making at least two cuts through the proximal edge of the annular body. As shown in the figure, the leaf spring is formed from two generally parallel cuts to allow the metal to be bent to form the leaf spring and to form the two side edges of the leaf spring at the proximal end of the annular body.

In one example, all of the leaf springs included in the present locking device may be formed in the same manner, for example, using two generally parallel cuts. In other examples, the cuts may be non-parallel. In other examples, a combination of different leaf springs may be used. For example, the ring body may have two proximally located leaf springs with slits formed through the proximal end of the ring body, and two leaf springs formed between the distal end and the proximal end of the ring body.

In one example, the cut or cuts to form the leaf spring may be made through the proximal edge of the annular body, or may be made proximate but distant from the proximal edge of the annular body.

In other examples, fewer than four leaf springs, such as three, two, or one, or more than four leaf springs, such as five, six, or seven leaf springs, may be used. In addition, the distance between the notches can be changed to change the width or size of the leaf springs, which can change the spring force or the bias force generated by the leaf springs.

Slots through the proximal end to form leaf springs may have the advantage of creating proximal portions between two adjacent leaf springs. The proximal portions may deflect or flex as the locking device is pushed into the catheter hub to secure the valve. The ability of the proximal portions to deflect or flex may reduce the insertion force for insertion of the fixation device. As in the embodiment described above or elsewhere, there may be a cutout rather than a slot between the leaf spring and the proximal end of the annular body. This may increase the flexibility of both the leaf spring and the proximal end of the annular body.

The locking device and the valve actuator nose portion may be spaced apart at a proximal position of the valve actuator. The gap or distance therebetween may provide clearance for the valve actuator to move distally to open the valve, such as to deflect the valve leaflets, before contacting or colliding with the locking device. In the illustrated state, the drive end at the nose of the valve actuator may be located within the hole defined by the locking device, but at a distance from the locking device, i.e. without contact with him.

The drive end and nose portion may be spaced from the cylinder by a plurality of leaf springs. Such distance or clearance may allow the valve actuator to move forward in a distal direction prior to impacting or contacting the retaining device, such as impacting leaf springs. The driving end may contact the proximally facing surface of the valve in a ready-to-use position. In other examples, the driving end may be slightly away from the proximally facing surface of the valve.

In one example, the valve actuator is configured to move distally as the luer cone advances. The amount or distance that the valve actuator moves distally must be sufficient to cause the actuator end and nose to deflect the valve leaflets distally and open the slots and thereby fluid communication between the Luer cone and the catheter tubing. In the example shown, the drive end of the valve opening device is moved distal to the valve leaflets, and the valve leaflets may be compressed between the inside of the catheter hub and the conical surface of the nose piece, or the valve leaflets may be deflected or deformed distally by the nose portion of the valve opening device, with or without compression. him. As shown, the driving end moves a distance equal to or shorter than the ends of the valve flaps, but the valve opens enough to allow free flow in both directions.

In one example, the conical surface of the nose deflects or displaces a plurality of leaf springs radially outward to provide stored energy to the leaf springs. The curved edge can act as a biasing element. Thus, upon releasing the leaf springs, the leaf springs apply a pair of force components or force vectors to the nose portion of the valve actuator, which may include a force acting generally parallel to the longitudinal axis of the catheter hub in the proximal direction.

When the Luer cone is removed, such as when replacing an IV bag attached to the Luer cone, the distal force acting on the proximal edges of the two Luer cone plunger elements is eliminated or terminated and the Luer cannula is left unoccupied by an external object. This may allow the valve actuator to return to its proximal position, now cleared by the luer cone. In one example, the elasticity of the valve allows the valve leaflets to release stored energy and return to a more relaxed state. This returning action of the valve leaflets and the shape of the valve actuator nose may allow the valve leaflets to apply force vectors to the nose to cause movement of the valve actuator from a distal position to a proximal position. In addition, the leaf spring or leaf springs acting on the nose portion may also apply a proximally directed force to further support the return of the valve actuator to the proximal position.

Because the valve actuator can move to a distal position inside the valve, for example, when the luer cone is pressed to open two or more valve leaflets, and the valve actuator can return to the proximal position when the luer cone is removed to allow the valve leaflets to relax or close to close the slots, the valve may go through several actuation cycles. In one example, the valve may undergo two or more actuation cycles. For example, the valve may undergo at least three cycles, at least four cycles, at least five cycles, or more. Each actuation cycle may include movement of the valve actuator into the valve to deflect the valve flaps and movement away from the valve to close the valve flaps.

Another aspect of the invention is a catheter assembly including a catheter hub body having a side port indicating a proximal direction and having an elongated body formed at an acute angle to the longitudinal axis of the hub body. The side port can be made integral with the catheter hub body. A side port catheter hub may be called or referred to as an integrated catheter, which is discussed in more detail below.

An integrated side port catheter may have the same components located within the catheter hub as other catheter hubs described herein. For example, the hub of an integrated catheter assembly may have a valve, a valve opener, a locking device, and a needle guard mechanism located within the catheter hub. If desired, the locking device can be made integral with the valve. If desired, the needle guard may be located outside the catheter hub, for example in a third hub that is separate from the catheter hub and the needle hub.

The side port may have a channel with an inlet port. The side port channel may be in fluid communication with the interior cavity of the catheter hub and the lumen of the catheter tube. In one example, the side port opening may be in fluid communication with an internal chamber or internal cavity distal to the valve and lumen of the catheter.

Once the needle and needle hub are removed following successful venipuncture from the catheter hub, one or more valve leaflets may close to divide the internal cavity into a distal chamber distal to the valve and a proximal chamber proximal to the valve. The side port can be isolated from the proximal chamber of the internal cavity thanks to a valve. However, when the needle is in the catheter tubing and the needle deflects one or more valve leaflets, fluid communication with the proximal chamber may occur.

The tube may be connected to the side port, and a fluid connector may be connected to the opposite end of the tube.

A vent plug similar to other vent plugs described herein may be attached to the proximal opening of the needle hub. An optional petal grip can be combined with a needle hub, and the needle hub can be used with a catheter hub. When combined, the petal gripper can provide a grip that is closer to the puncture site when the needle is inserted into the vein. In general, the closer to the injection site, the more accurate the injection can be. When combined, the petal gripper can be formed integrally with the needle hub.

The petal gripper may be a generally flat structure extending away from the needle hub and having a length extending distally. The petal gripper may have a hump-shaped or curved outer contour with a rounded outer edge, or may have another shape. Superficial tubercles or gripping elements may be included in the petal gripper to facilitate gripping.

The petal grip can be adjusted for left-handed or right-handed use by rotating the needle hub around the longitudinal axis of the needle. In some examples, the petal grip may be formed by a clamp ring, and the clamp ring may slide over the needle hub. The clamping ring can be adjustable or rotatable relative to the needle hub, allowing the position of the scapula grip to be changed as desired by the physician. Examples of adjustable paddle grippers are disclosed in US publication. Pub. No. 2017/0173304 A1, the contents of which are expressly incorporated herein by reference.

The valve and valve actuator may be located within the hub of the integrated catheter. The valve may be the valve shown in FIG. 13 and may be supported between the distal shoulder and the proximal shoulder. The valve may have more than one slot and two or more flaps, for example, three slots and three flaps or four slots and four flaps. The valve may have a valve disc with a constant thickness or with a variable thickness.

The valve actuator may be located proximal to the valve and may include a nose portion with an actuating end for pressing into the valve and opening one or more slots of the valve disk to deflect two or more leaflets. The valve actuator may include at least one plunger element, with two spaced apart plunger elements being more preferred, which may have one or more clearances between them for fluid flow.

The stabilizing element may be connected or attached to two plunger elements. Two stabilizing elements may be connected to two plunger elements at opposite side edges of the plunger elements. The two stabilizing members and the two plunger members may define an inner opening that is smaller relative to the size of the needle guard mechanism at the two corner portions when the needle is displaced, as previously described. Thus, when the needle moves the two arms of the needle guard laterally, the two stabilizing elements prevent proximal movement of the needle guard due to the difference in size.

In one example, the corner portions of the needle guard mechanism are located distal to two stabilizing elements, distal to the inner collar within the catheter hub. Thus, in addition to the two stabilizing elements, the needle guard mechanism can be held within the catheter hub by the proximal collar in the ready-to-use position and during needle retraction until the needle tip moves proximal to the two distal walls of the two legs, as discussed previously.

A tube or length of tube may be connected to the side port by a first end of the tube and to a fluid connector by a second end of the tube. The fluid connector can be a number of different devices, such as a plug baffle or a needleless valve. In one example, the fluid connector is a needleless valve including a housing with a movable piston located within it. The housing may have an inlet with a Luer cannula to receive a Luer cone such as a syringe tip. A syringe can be used to open a hydraulic connector without a needle by applying pressure to the plunger.

When inserted into the inlet port of the hydraulic connector, the Luer cone of the syringe can press against the plunger to open a path for fluid between the inlet and outlet of the housing. The output of the housing is connected to the tube. Thus, a fluid such as a drug, supplement, or medication released from a syringe through a luer cone can pass through the needleless valve or hydraulic connector, body outlet, into the tubing, then through the side port, then into the distal chamber of the catheter hub, then into the lumen of the catheter tube and enter the patient.

During use, the side port catheter assembly of the integrated catheter assembly can be grasped using the petal gripper, if available, and then inserted into the vein using the needle tip and catheter tubing tip. If the petal grip is missing, the clinician can grip the needle hub and possibly the catheter hub together. The initial flash of blood can be observed when blood passes through the needle and enters the needle hub. If a primary flash of blood is confirmed, the physician may pull the needle proximally to allow blood to pass between the needle and the catheter tube and check for a secondary flash of blood.

If a secondary blood flush is confirmed, the user can insert the catheter assembly further into the vein, advancing the catheter tubing further into the vein to access the vessel. The needle and needle hub can then be completely removed from the catheter tubing and catheter hub. As the needle is retracted, the tip of the needle will move proximally away from the two distal walls of the needle guard, allowing the two arms of the needle guard to come together and free themselves from the stabilizing elements. Because the thickened portion engages the hole on the proximal wall of the needle guard, further retraction of the needle will remove the needle guard from the catheter hub. If the needle is pulled straight out of the catheter hub, the thickened portion may not engage the hole in the proximal wall of the needle guard mechanism.

Once the needle is removed from the integrated catheter, the multiple flaps of the valve may retract or return to a relaxed state to close the slots and restrict flow proximally and distally through the valve. In one example, the drive end on the nose of the valve actuator may be proximal to the valve in the proximal valve actuator position, spaced from the proximally facing surface of the valve, and spaced from the locking device, if provided.

The conical surface of the nose is also at a distance from the locking device, if provided. This distance or clearance between the nose and the locking device, if any, allows the valve actuator element to move forward in the distal direction as it is pushed by the luer cone before colliding with the locking device. This arrangement provides space for the valve actuator to move distally to open the valve. In one example, distal advancement of the valve actuator may be stopped when the Luer cone contacts the Luer cannula of the catheter hub during Luer seating, as described herein. The drive end of the nose piece may be positioned at a distance from the proximally facing surface of the valve in a ready-to-use position where the tip of the needle extends distal to the distal opening of the catheter tubing and is in the proximal valve drive position. In other examples, the drive end may contact the proximally facing surface of the valve before it is advanced distally by the luer cone.

In one example, the drip line of the IV set may be connected to the hub of the integrated catheter through the proximal opening of the catheter hub. When the catheter hub is occupied by an intravenous administration set, a fluid connector coupled to the catheter hub via tubing and a side port can be used to administer medication to the patient, for example, through a syringe. In an alternative embodiment, the drip line of the IV set may be connected to a fluid connector and the proximal opening of the catheter hub may be used to administer medication, for example, through a syringe.

The valve actuator in accordance with many other embodiments of the invention may include a transition portion having a taper formed by several inclined segments. In other examples, the transition portion may be a smooth curve or a single inclined cone that increases from the nose in a proximal direction. The valve actuator nose distal to the transition portion may have a generally frustoconical shape and a through hole for fluid flow. The conical nose surface may allow the valve leaflets to apply a pair of component forces, which may include a proximally directed force, to return the valve actuator to the proximal position after removal of the Luer cone.

In one example, the valve actuator includes two stabilizing elements. Each stabilizing element can be connected to two plunger elements. Compared to the stabilizing elements of FIG. 33, at least one of the alternative valve actuator stabilizing elements may have a width defined between the distal edge and the proximal edge, which may vary along the length of the bridge defining the stabilizing element. For example, the stabilizing element may have a width between a first end and a second end, or two ends, that are attached to two plunger elements, and the width may be narrow near the two ends, but wider near the middle of the length.

The wider part of the stabilizing element can be from 25% to 75% of the length of the stabilizing element. However, as with the valve actuator of FIG. 33, one or both stabilizer elements may have the same width along their entire length, similar to the bridge defining the stabilizer element of FIG. 33. In one example, the wider portion may be located centrally between two ends of the stabilizing element. In some examples, a cutout or recess may be provided at the proximal edge of one or both stabilizing elements.

In one example, the distal edge of the wider portion of the stabilizing element may have a sloped edge. The slope of the sloping edge should begin at or near the outer surface of the stabilizing element and slope toward the inner surface of the stabilizing element. In other words, the tip of the inclined edge should be closer to the outer surface of the stabilizing element than to the inner surface of the stabilizing element. The slanted edge configuration can make it easier to release the needle guard mechanism. If there are two stabilizing elements, both distal edges of the two stabilizing elements may include an inclined edge.

In some examples, each of the two stabilizing elements of the valve opening device may have the same width along its entire length, and both constant-width stabilizing elements may have a sloping distal edge. For example, the distal edges of the two stabilizing elements may have a sloped edge. In some examples, the valve actuator may have two stabilizing elements, one of which has the same width along its entire length and the other of which has a wider portion at a central location along its entire length. One or the other or both of the stabilizing elements may have a sloping distal edge. In other examples, one or both distal edges of two different stabilizing elements may have a typical square or straight top and bottom edge, which may also allow the needle guard mechanism to be released.

The two plunger elements may have portions that extend proximally from the proximal edge of the stabilizing element. In some examples, the proximal edge of the two plunger elements and the proximal edge of the stabilizing element or both stabilizing elements may end generally along the same vertical plane. In an embodiment where the proximal edges end generally along the same plane, the distal edge of the stabilizing element can be elongated in the distal direction, for example, by increasing the width of the stabilizing element. Changing the location of the distal edge can be used to control the interaction between the needle guard and the stabilizing element.

In accordance with further aspects of the invention, the needle guard mechanism includes a proximal wall having a perimeter defining an opening for receiving the needle and for engaging a thickened portion formed with the needle. Two tarsi may extend distally from the proximal wall. Each leg may have a distal wall and a corner portion located between the distal wall and the elongate portion of the leg.

Ribs or projections may be included in various parts of the needle guard mechanism to provide additional rigidity or hardness. Protrusions or ribs may be provided on the edges of the proximal wall, on each of the two elongated leg portions, and on the distal walls. In a preferred embodiment, each distal wall is provided with a curved edge such that the curved edge abuts the side surface of the needle when the needle is positioned between the two legs. The curved edges can be combined with a needle guard so that the needle does not rest against the edge of the distal wall, which can cause scraping, but rather against the flat outer surfaces of the curved edges. In some examples, projections or ribs may be lowered on the distal wall, such as on the curved edge of the first or longer leg.

The two arms of the needle guard mechanism intersect each other in the side view, shown in both the stowed or open needle position and the guarded or needle guard position. In other examples, the two legs may extend distal to the proximal wall on their respective sides of the needle shaft, but not intersect the needle axis.

When the needle no longer displaces the two arms of the needle guard and the two arms are allowed to move closer to each other, the distance measured between the two corner portions is reduced compared to the distance with two corner members when both arms are offset by the needle. The needle can be retracted proximally until the thickened portion abuts the perimeter defining the opening on the proximal wall. The perimeter of the proximal wall may be smaller than the largest cross-sectional dimension of the thickened portion. This allows the needle to move proximally and engage the perimeter to remove the needle guard along with the needle.

The two arms of the needle guard mechanism can have two different lengths. Thus, in the guard position, the two distal walls can overlap when looking down the axis of the needle. In one example, the angle between the distal wall and the elongate portion of the first leg may be greater than the angle between the distal wall and the elongate portion of the second leg.

In one example, each elongated portion of the two tabs may be generally straight or linear, with possible slight bending or bending as the needle moves to the corresponding corner portion. A single radius bend is then provided to form the corresponding corner portion and the corresponding distal wall. Another single radius bend may be provided to form a corresponding curved edge. On a corner section, a single radius bend can have a simple or complex curve. However, unlike the needle safety mechanism of FIG. 4 and 5, which has at least two bends and two changes of direction between the elongated portion of the tab and the distal wall of each tab, the illustrated needle guard mechanism may have one bend and one change of direction between the elongated portion of the tab and the distal wall of each tab.

One bend and one change of direction creates a smooth or flat profile between the extended portion of the tab and the corner portion. The flat profile on the tab should be positioned to minimize or reduce contact interference with the edge of the valve actuator stabilizing element, such as sticking or hanging. Thus, there may be additional bends or changes of direction on each tab downstream of the first bend forming the corner portion, provided that the transition between the extended portion of the tab and the first bend to form the corner portion is generally flat or smooth to eliminate potential snag points , which can cause jamming or binding, for the typical range of angles at which the needle is oriented during withdrawal. In general, during use, the needle is pulled straight out of the catheter hub along the same axis. In extreme cases, the needle can be withdrawn at an angle until the needle touches the top of the proximal opening of the catheter hub. If the needle is pulled out at an angle greater than just touching the proximal opening of the catheter hub, this is misuse and may cause the needle to bend.

The needle guard tabs may have a smooth or flat profile between an elongated tab portion and a corner portion with a single bend or change in direction. As shown, each elongated portion of the first and second legs may have portions of different widths. Each foot may also include a cutout with a hook-like edge. A cutout or cutouts on the two tabs allow the tabs to enclose the needle to provide lateral stability as the needle transitions from the ready-to-use position, where the needle tip is exposed, to the protected position, where the needle tip is protected.

Embodiments of the needle guard mechanism described herein may be manufactured from stamped metal sheet, such as stamped stainless steel sheet, using a stamping and bending method to form the needle guard mechanism in the shape shown.

When the needle tip is retracted proximally away from the two distal walls of the needle guard mechanism after successful venipuncture, needle displacement of the two legs is eliminated, allowing the two legs to approach or touch each other. This in turn reduces the size measured at the two corner portions, which is reduced to allow the needle guard mechanism to move proximally through the opening defined by the two stabilizing elements and the two plunger elements. However, during retraction of the needle and the needle safety mechanism through the hole, the healthcare professional may inadvertently tilt the needle during proximal retraction. When this occurs, during retraction the needle guard may come into contact with the distal edge of one or both of the stabilizing elements, thereby catching and possibly becoming stuck as a result of contact between the needle guard and the stabilizing element. This, in turn, will make it difficult to remove the needle safety mechanism through the hole.

It is known that when the needle guard tab has more than one bend or change of direction at the transition between the elongated portion of the tab and the corner portion, multiple changes in direction can catch the distal edge of one stabilizing element as the needle guard is retracted through the hole when withdrawing the needle. This, in turn, requires the user to change the angle of the needle relative to the longitudinal axis of the catheter hub to a value that is less than the maximum angle A during needle retraction to avoid snagging and interfering with the retraction of the needle safety mechanism. In contrast, when a needle guard mechanism is used with a valve actuator having one or two stabilizing elements, a single bend or change of direction between the elongated portion of the tab and the corner portion produces a smooth or flat profile that cannot easily engage the distal edge of one or both stabilizing elements during needle retraction.

Thus, retraction through the hole can be facilitated by using a needle guard mechanism having a tab with one bend or change of direction to produce a smooth or flat profile that does not easily catch on the distal edge. Thus, the user can set the angle of the needle relative to the longitudinal axis of the catheter hub to the maximum angle B during retraction to avoid snagging and difficulty in retraction, as clearly shown in FIG. 47 and 48 for discussion purposes. For two identically sized catheter assemblies with identically sized components but different needle guards, one with one bend or change of direction and the other with two or more bends or changes of direction, angle B is greater than angle A.

When the stabilizing member that the needle guard contacts or contacts during proximal retraction has a slanted edge, the likelihood that the transition between the corner portion and the elongated leg portion of the needle guard engages the slanted distal edge is reduced. Thus, even if the needle guard mechanism has two or more bends at the corner portion and the catheter assembly has a stabilizing member with an inclined edge, a user holding the same size catheter assembly can hold the needle at a greater angle A', which is greater than angle A Similarly, if the needle guard mechanism has only one bend or change of direction to produce a smooth or flat profile that does not easily engage the distal edge, a user holding a catheter assembly of the same size may hold the needle at a greater angle B', which is greater than angle A. Generally speaking, the angle B' corresponding to the needle safety mechanism with one bend or change of direction and the valve drive with the inclined edge stabilizing element is greater than the angle A' corresponding to the needle safety mechanism with two or more bends or changes of direction and valve actuator with a stabilizing element with an inclined edge.

It is further understood that objects of the invention include a catheter assembly comprising a catheter tube having a lumen, an opening at a distal end and a proximal end connected to a catheter hub, the catheter hub including a catheter body with an outer surface and an inner surface defining an internal cavity, comprising at least one bead; a needle having a needle tip at a distal end and a proximal end attached to a needle hub; a needle extending through the catheter hub and through the catheter tubing and having a needle tip projecting distal to the distal end opening in a ready-to-use position; a valve having a valve body including at least one slot, a proximally facing surface and a distally facing surface located in an internal cavity of the catheter hub; a valve actuator located in an internal cavity of the catheter hub, wherein the valve actuator has a nose portion with an opening and a proximal portion with at least one gap for fluid flow through or over it, and is movable between a proximal position and a distal position within the internal cavity when pressed with a Luer cone; a needle safety mechanism comprising a safety surface located lateral to the needle in a ready-to-use position and extending to a position distal to the tip of the needle in a safety position to cover the tip of the needle from accidental needlestick injury; wherein the needle guard mechanism has a tab with an angular portion between the elongated portion of the tab and the distal wall, and wherein the angular portion has one change of direction at a location that can contact the stabilizing element on the valve actuator during retraction of the needle guard mechanism without being caught or obstructed and/or stopping needle movement.

The locking device may be in contact with the valve or be an integral part of the valve on a proximally facing surface of the valve body for retaining the valve in an internal cavity of the catheter hub, wherein the locking device may include a lock body having an internal surface defining an opening including a fluid path, distal end and proximal end.

The catheter hub may have a side port connected to the tubing at a first end of the tubing. A fluid connector (hydraulic connector) may be connected to the second end of the tube. The hydraulic connector may be a needleless connector. The catheter assembly can be called an integrated catheter assembly.

The valve actuator stabilizing element may have a distal edge. The distal edge may have a sloping edge. The slope of the sloping edge should begin at or near the outer surface of the stabilizing element and slope toward the inner surface of the stabilizing element. In other words, the end of the inclined edge should be closer to the outer surface of the stabilizing element than to the inner surface of the stabilizing element.

The needle guard mechanism may have a tab with one change of direction between the elongated portion of the tab and the distal wall of the tab to provide a smooth or flat profile at the corner portion between the elongated portion of the tab and the distal wall that does not easily engage the distal edge of the valve actuator stabilizing member.

Methods for making and using catheter assemblies and components thereof are within the scope of the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features and advantages of the presented devices, systems and methods will become more clear from the following description, claims and accompanying drawings, where: FIG. 1 is a simplified perspective view of a catheter assembly or needle device in accordance with embodiments of the invention.

In fig. 2 is a partial sectional perspective view of the assembly of FIG. 1.

In fig. 3 is an exploded view of the needle device or catheter assembly of FIG. 1.

In fig. 4 is an enlarged partial sectional side view of the assembly of FIG. 1.

In fig. 5 is a cross-sectional side view of the assembly of FIG. 4, rotated 90 degrees.

In fig. 6 is a cross-sectional side view of the assembly of FIGS. 1-5 with the needle and needle hub removed, for example after successful venipuncture, and with the valve actuator in the proximal position.

In fig. 7 is a cross-sectional side view of the assembly of FIG. 6 with the valve actuator in its distal position and the valve open.

In fig. 8 is a cross-sectional side view of one embodiment of a catheter assembly or needle device with the needle and needle hub removed, for example after successful venipuncture, and with the valve actuator in the proximal position.

In fig. 9 is a cross-sectional side view of the assembly of FIG. 8 with the valve actuator in its distal position and the valve open.

In fig. 10 is a cross-sectional side view of another embodiment of a catheter assembly or needle device with the needle and needle hub removed, for example after successful venipuncture, and with the valve actuator in the proximal position.

In fig. 11 is a cross-sectional side view of the assembly of FIG. 10 with the valve actuator in its distal position and the valve open.

In fig. 12 shows a side view, a front view and a front perspective view.

a sectional view of a locking device in accordance with embodiments of the invention.

In fig. 13 shows a side view, a front view and a perspective view of the valve and

a sectional view of the locking device in accordance with embodiments of the invention.

In fig. 14 shows a side view, a front view and a perspective view of another

a sectional view of the locking device in accordance with embodiments of the invention.

In fig. 15 shows different types of spring-shaped locking device.

In fig. 16 is a cross-sectional side view of another embodiment of the catheter assembly or needle device with the needle and needle hub removed and with the locking device of FIG. 15.

In fig. 17 is a side view of the assembly of FIG. 16 is a cross-section with the valve actuator in its distal position and the valve open.

In fig. 18 is a side cross-sectional view of another embodiment of a catheter assembly or needle device with the needle and needle hub removed, for example, after successful venipuncture and with the valve actuator in the proximal position.

In fig. 19 is a side view of the assembly of FIG. 18 is a cross-section with the valve actuator in its distal position and the valve open.

In fig. 20 is a side cross-sectional view of another embodiment of a catheter assembly or needle device with the needle and needle hub removed, for example after successful venipuncture, and with the valve actuator in a proximal position.

In fig. 21 is a cross-sectional side view of the assembly of FIG. 20 with the valve actuator in its distal position and the valve open.

In fig. 22 shows a side view, a front view, and a cross-sectional perspective view of another locking device in accordance with embodiments of the invention.

In fig. 23 is a cross-sectional side view of another embodiment of a catheter assembly or needle device with the needle and needle hub removed, for example, after successful venipuncture and with the valve actuator in the proximal position.

In fig. 24 is a cross-sectional side view of the assembly of FIG. 23 with the valve actuator in its distal position and the valve open.

In fig. 25 is a perspective view of a locking device, which may be an eyelet.

In fig. 26 is a perspective view of a locking device, which may be an eyelet in accordance with other embodiments of the invention.

In fig. 27 is a side cross-sectional view of another embodiment of a catheter assembly or needle device with the needle and needle hub removed, for example, after successful venipuncture and with the valve actuator in the proximal position.

In fig. 28 is a cross-sectional side view of the assembly of FIG. 27 with the valve actuator in its distal position and the valve open.

In fig. 29 is a side cross-sectional view of another embodiment of a catheter assembly or needle device with the needle and needle hub removed, for example, after successful venipuncture and with the valve actuator in the proximal position.

In fig. 30 is a cross-sectional side view of the assembly of FIG. 29 with the valve actuator in its distal position and the valve open.

In fig. 31 is a side cross-sectional view of another embodiment of a catheter assembly or needle device with the needle and needle hub removed, for example, after successful venipuncture and with the valve actuator in the proximal position.

In fig. 32A is a cross-sectional side view of the assembly of FIG. 31 with the valve actuator in its distal position and the valve open, and in FIG. 32 V - the same view, rotated 90 degrees.

In fig. 33 is a perspective view of a valve opening device in accordance with embodiments of the invention.

In fig. 34 is a perspective view of a valve consisting of a valve disc and a skirt portion.

In fig. 35 is a perspective view of a valve including a valve disk and a skirt portion in accordance with other embodiments of the invention.

In fig. 36 is a cross-sectional side view of another embodiment of a catheter assembly or needle device with the needle and needle hub removed, for example after successful venipuncture, and with the valve actuator in a proximal position.

In fig. 37 is a cross-sectional side view of the assembly of FIG. 36 with the valve actuator in its distal position and the valve open.

In fig. 38a is a perspective view of a locking device consisting of a plurality of leaf springs, and FIG. 38 b - front view.

In fig. 39-41 are cross-sectional views of an alternative catheter assembly in accordance with other embodiments of the invention that may include a side port.

In fig. 42 is a perspective view of an integrated catheter assembly including a side port connected to a tube that is further connected to a fluid connector.

In fig. 43 is a perspective view of a valve actuator in accordance with other embodiments of the invention.

In fig. 44 is an enlarged cross-sectional view of a stabilizing element having a tapered distal edge.

In fig. 45A and 45B show a needle guard mounted on a needle, the needle guard having a tab with one bend or one change of direction.

In fig. 46A and 46B are various perspective views of the needle guard mechanism in an open state, as if the needle (not shown for clarity) opens its claws to show the features of the needle guard mechanism.

In fig. 47 shows the state of removing the needle from the catheter hub. For simplicity, the catheter tube protruding from the distal end of the catheter hub is not shown.

In fig. 48 is an enlarged view of the area of FIG. 47.

DETAILED DESCRIPTION

The present disclosure relates generally to needle devices, and in particular to catheter assemblies with improved valve systems, and related improved methods. The improvements include a number of individual components and a combination of components. By way of example, improvements include the structure and function of securing a valve to a standard diameter catheter hub, providing a proximally directed axial force to return the valve actuator, also called valve actuator, from a distal position to a proximal position when the Luer cone is disconnected from the catheter hub, integrating into an integral component or components within a single-body catheter hub that can restrict fluid flow, enable actuation of fluid flow control, prevent needle-related injury, and combinations thereof. A single-body catheter hub is defined as a one-piece catheter hub with a catheter tube extending from the distal end of the hub and an opening at the proximal end to accept a pin medical instrument, such as a Luer cone.

In fig. 1 shows a catheter assembly 100, also referred to as a needle device or needle-enclosing catheter assembly, comprising a catheter hub 102 with a catheter tube 104, a needle hub 106 with a needle 108 attached thereto, and a needle protruding through the catheter hub 102 and the lumen of the catheter tube 104. At the proximal end of the needle hub 106 is a vent plug 112, which is specifically attached to the proximal opening of the needle hub 106. The bevel of the needle at the needle tip 114 projects distally from the distal opening or opening 116 of the catheter tube 104 in the ready-to-use position of FIG. 1. The needle hub 106 is connected to the catheter hub 102 at the proximal opening of the catheter hub, which may have an internal Luer thread or a Luer slip. The catheter hub 102 may include a push projection and one or more surface features, such as ridges, for pushing the catheter tube 104 into the patient's vein and encircling the needle 108. The needle hub 106 may also include surface features to provide a more secure grip when puncturing the vein and removing the needle 108 from tube 104 catheter. Unless otherwise noted, the various components can be manufactured from conventional materials using conventional techniques.

In one example, a pair of wings may be included in the body 126 of the catheter hub 102, and each wing may extend away from the longitudinal axis of the catheter hub in opposite directions at the bottom of the catheter hub. A pair of wings can be used by the physician to secure the catheter hub to the patient after successful venipuncture, for example, using adhesive tape or an adhesive bandage.

In fig. 2 is a partial cross-sectional perspective view of the needle assembly 100 of FIG. 1, in which the catheter hub 102 is opened along the longitudinal direction to reveal the valve 120 and valve actuator 122 located within the inner cavity 123 of the catheter hub 102. The valve and valve actuator may be included to control the flow of fluid through the catheter hub, for example, to control infusion or aspiration through the catheter hub, as described in more detail below. Also shown within the inner cavity 123 is a needle safety mechanism or needle tip protector 130, which may have a surface or wall to prevent accidental contact with the needle tip when the needle is withdrawn from the catheter tube and the catheter hub after successful venipuncture.

The needle guard mechanism or needle tip protector 130 may be structured with one or more components to prevent inadvertent contact with the needle tip. For example, the needle guard mechanism 130 may have a structure or wall that moves from a position lateral to the needle shaft and proximal to the needle tip to a position distal to the needle tip to cover or block the needle tip from accidental contact. In one example, the needle safety mechanism 130 may be one of the types described in US Pat. No. 10,166,370, the contents of which are expressly incorporated herein by reference. Options for exemplary needle guard devices are discussed in more detail below.

The catheter hub 102 has a body 126 with an outer surface and an inner surface defining an internal cavity 123. The internal cavity 123 may include one or more projections or stops 176 a, 176 b, 176 c (FIG. 4), which can be used to seating the valve actuator 122, valve 120, and/or needle guard 130 in a ready-to-use position. The needle guard mechanism 130 may be placed into the interior of the catheter hub 102 by a nose portion 132 of the needle hub 106 that projects into the proximal opening 136 of the catheter hub 102. As shown, the needle assembly or catheter assembly 100 of FIG. 2 may be provided with a catheter hub 102 having an internal portion 123 with a valve 120, a valve actuator 122, and a needle guard 130 disposed therein in a ready-to-use position. In one example, the needle guard 130 is optional and can be omitted. In other examples, the needle guard mechanism 130 may be located substantially external to the catheter hub. For example, the finger or finger portion of the needle guard may be located within the catheter hub, and the remaining structure of the needle guard may be located outside the catheter hub.

Also shown is the catheter hub 102 located in the internal cavity 123 of FIG. 2, a device or structure 124 for securing or retaining the valve 120 within the catheter hub 102, which may generally be referred to as a retaining device, retaining ring, or member 124. The retaining device, ring, or member 124 may have a structure that is a retainer, retaining ring. , retaining the skirt, O-ring of various possible cross-sections, such as round, oval, square, rectangular, or conical coil spring, among others. The locking device 124 may be formed separately from the valve 120 or be part of the valve, for example, used in conjunction with the valve, integrated with the valve, or integral with the valve. Unless the context indicates otherwise, the term locking device 124 may refer to any of the above structures and their equivalents. In one example, the locking device 124 is located in line with the valve 120, the valve actuator 122, and the needle guard 130. In a specific example, the locking device 124 has a channel for receiving a needle 108 and is in contact with the valve and the interior of the catheter hub 102 to limit the proximal movement of the valve 120 in the interior portion 123, to assist in returning the valve actuator 122 from a distal position to a proximal position, or for both purposes, as described in more detail below. The valve actuator or portion of the valve actuator 122 may be located within the bore of the locking device 124 as in the ready assembled catheter position, as shown in FIG. 1, and in the position used, for example, after successful venipuncture, which will be discussed in more detail below.

As shown, the needle guard mechanism 130 may include a metal spring or elastic body, a proximal wall 140, and at least one tab or two tabs (as shown) extending distally from the proximal wall 140. A thickened portion 142 formed on the needle shaft proximal to the tip 114 the needle in and around it may engage the perimeter defining the opening on the proximal wall 140 to limit distal movement of the needle guard from the needle but allow the tip 114 to enter the needle guard 130. The thickened portion 142 may be a corrugation, an extension of material, a sleeve, or any other increase in diameter that is larger than the opening in the proximal wall 140.

In fig. 2 shows valve 120, valve actuator 122, locking device 124, and needle guard mechanism 130 that are sized and shaped, for example, to accommodate within interior space 123 a catheter hub 102, which may have a one-piece hub body, such as a monolithic hub body. , with a proximal opening having a Luer cannula and a distal end from which a catheter tube extends, optionally with male threads or ears (as shown). In other examples, the catheter hub body 102 may be constructed from multiple parts. For example, the catheter hub 102 may have a first hub body attached to a second hub body, such as by gluing or welding, to form the catheter hub body 102.

In fig. 3 is an exploded perspective view of the catheter assembly or needle device 100 of FIG. 1 with an exemplary valve 120, an exemplary valve actuator 122, and an exemplary locking device 124. FIG. 3 also shows a catheter hub 102, a catheter tube 104, a needle 108, a needle guard 130, a needle hub 106, and a vent plug 112, which when combined or assembled may form the needle device 100 of FIG. 1 and 2. Also shown is a metal sleeve or fitting 146, which is conventional and can be used to secure the proximal end of the catheter tube 104 to the interior of the catheter sleeve 102. In other examples, as will be discussed in more detail below, valve 120, valve actuator 122, and/or locking device 124 may differ from the embodiment shown, such as having other specific design features. In some examples, the needle guard mechanism may be located outside the interior of the catheter hub, or substantially outside the catheter hub, with only the finger or protrusion partially extending into the catheter hub.

In one example, valve actuator 122 includes a nose portion 150 at the distal end of the actuator body. The nose portion 150 may have an elongated structure and may be generally cylindrical, or inclined, or conical and terminated at a drive end 180 (FIG. 7) for pressing into the valve 120 and opening the valve slots, as described in more detail below. The drive end of the nose portion 150 may have a blunt distal end surface or a sharp edge. A fluid flow path may extend through the nose portion 150. The nose portion 150 may have a wall surface with a continuous perimeter or a continuous portion of the perimeter defining a lumen or passage for flow. The wall of the bow can be without a gap or slot, for example in the form of a cylinder with a continuous wall. The nose portion 150 may define a channel. The channel may have a constant diameter or may vary depending on the taper of the nose. In some examples, a plurality of spaced apart slots and/or openings may be provided on the nose portion, eg, in the wall of the nose portion, to provide fluid flow or flushing.

Two drive elements or plunger elements 152 may extend proximally from the nose portion 150. For example, two plunger elements 152 may be formed separately from the nose portion 150, or may extend proximally from the nose portion. A gap or space may be provided between the two plunger members 152, which may define a holding space. The needle guard mechanism or needle tip protector 130 may be located in the holding space or between the two plunger elements 152. In one example, the two plunger elements 152 may have at least two longitudinal edges that are spaced apart from each other. The longitudinal edges of the plunger elements 152 may coincide with the longitudinal axis of the valve actuator 122. A gap or space may be provided between the two plunger elements to function as a flow path for fluid passing through or over it as the fluid passes through the catheter hub. In other examples, there may be more than one gap or flow path defined by the valve actuator for fluid flow. In other examples, two plunger elements may be connected by two webs such that the proximal end of the valve actuator is a continuous wall structure formed by a portion of the two plunger elements and the two webs. In some examples, the valve actuator uses a single plunger element.

In one example, a protrusion 154 extends outward from the outer surface of one or both plunger elements 152. As shown, a protrusion 154 extends from the outer surface of each plunger element 152. Each protrusion 154 is similar to a protrusion having a generally flat edge for abutting a shoulder or edge, formed in the inner part of the catheter hub 102. The surface of the projection 154 and the direction of the projection allow the valve actuator 122 to be inserted into the interior 123 of the catheter hub 102 and to be seated within the catheter hub, as described in more detail below. The projections 154 are sized and shaped to fit or contact a collar 176 within the catheter hub to limit proximal movement of the valve actuator 122.

In one example, a transition portion extends from the nose portion 150 and expands as the valve actuator body extends axially in a proximal direction. Two drive elements 152 may extend from the transition portion. Two drive elements 152 may alternatively extend from the nose portion 150 without a transition portion. In some embodiments, the nose portion 150 may have another shape, such as cuboid, rectangular, conical, pyramidal, shaped, or the like.

In one example, the valve actuator 122 has a longitudinal axis, with one or more actuator elements 152 extending axially or parallel to the longitudinal axis. In a specific example, two drive elements 152 are located diametrically opposite each other along the longitudinal axis. In other examples, the two drive elements may move away from each other as they move proximally. In other examples, the two drive elements may converge toward each other as they move proximally. The distance between two plunger elements, whether straight, converging or diverging, can define the space between them. As shown, the two plunger elements 152 define an outer diameter larger than the diameter of the nose portion 150. For example, the diameter defined by the two plunger elements 152 at the proximal end is greater than the diameter defined by any portion of the nose portion 150 excluding the projections 154. In some examples the diameter defined by the two plunger elements 152 is greater only than the diameter of the drive end at the nose. In some examples, the nose portion of the valve actuator is contoured, for example, with distinct lines by forming recesses in the nose portion with distinct contour lines or curves. One or more surfaces of the contoured nose portion can then be used to apply pressure to the valve, and upon reverse movement of the valve, push the contoured nose portion in a proximal direction to return the valve actuator to the proximal position, as described in more detail below.

In one example, the plunger elements 152 are flexible and deflectable such that when pressed by a luer cone tip, such as a syringe tip or a luer cone adapter, the drive elements 152 can deflect or flex. The drive elements 152 may be deflectable by selecting a material having the required elastic properties. In other examples, the drive elements 152 may be deflected by including one or more weakened portions, such as by including a structurally thin portion, by including notches, by using a small cross-section compared to other portions of the same elongated plunger element, or combinations thereof. In an alternative design, the plunger elements 152 may be flexible and deformable by selecting a material having the desired elastic properties and including one or more weakened areas.

In other examples, each plunger element 152 has more than one different cross-sectional profile or contour along a portion of its length. For example, the elongated plunger element may have a square profile adjacent to a crescent-shaped profile.

In one example, the drive elements 152 are rigid and non-deflectable and do not deform under load, such as when pushing a luer cone. Further, one or more stabilizing elements 158 may be incorporated to increase the rigidity of the two actuator elements 152. Each of the two actuator elements 152 may have a cross-sectional profile at least at the proximal end that overlaps the push end of the male tip so that the male tip can push the actuator valve inside the valve, as described in more detail below. The stabilizing elements 158 may have proximal edges located distal to the proximal edges 182 (FIG. 4) of the drive elements 152 or flush with the proximal edges of the drive elements.

The nose portion 150 of the valve actuator 122 may be configured to engage the valve 120 to open the valve flaps and slots formed therebetween when an axial force is applied by the pin tip to the plunger elements or the actuator elements 152 to move the valve actuator 122 into the valve for deflection. valve leaflets, for example, during insertion of the Luer cone of an IV or IV set. Typically, the valve actuator nose 150 is rigid relative to the more compliant valve 120, which allows the nose 150, and more specifically the nose drive end 180 (FIG. 7), to actuate the valve 120, such as to deflect one or more flaps and open one or more slots on the valve 120. The nose portion 150 may be made of an incompressible material, such as metal, rigid plastic, or rigid elastomer, to press against the valve and open it.

An exemplary embodiment of valve actuator 122 includes a pair of opposing strips or stabilizers 158 connecting two actuators 152 along the length of the actuators and located between the nose 150 and the proximal end of the actuators. In some examples, stabilizers 158 may be located at the proximal end of two drive elements 152 such that the proximal edges of the stabilizers 158 are generally flush with the proximal end surfaces of the drive elements 152. The two stabilizer elements or strips 158 may be referred to as a first or upper stabilizer element and a second or lower height stabilizing element.

In one embodiment, the stabilizers or stabilizing elements 158 have arcuate wall surfaces, forming an arc that generally follows the internal profile of the catheter hub 102 and connects one plunger element 152 to another plunger element 152. The stabilizers or stabilizing elements 158 may form a substantially continuous cylindrical portion on a valve actuator body which is formed by two stabilizing elements and two plunger elements at a distance from the nose 150 of the valve actuator 122. In other words, the valve actuator 122 may be elongated and may have portions that are radially continuous and portions with outlets or through passages through the actuator wall that are not radially continuous.

In one example, stabilizers 158 define a continuous body portion along the perimeter or radial direction of the valve actuator that is spaced from a continuous body portion of the nose portion 150 that is also continuous along the perimeter or radial direction. Two stabilizer or stabilizing elements 158, also called strips, may be connected together with two plunger elements 152 to form a ring structure. Optionally, the two stabilizers 158 may be slightly offset and angled toward each other in the longitudinal direction of the valve actuator 122. In some embodiments, there may be one, three, or another number of actuator elements 152 or stabilizers 158. For example, there may be two actuator elements 152, but only one stabilizer or strip 158. In one example, a valve actuator 122 with stabilizers or stabilizer elements 158 and projections 154 is made of plastic, for example by injection molding.

The stabilizers 158 may help the valve actuator 122 remain centered in the catheter hub 102 when the actuator 122 is moved, such as when pressing the luer cone to open the valve slots. By centering, the nose portion 150 can be better aligned with the valve disc 121, such as with slots on the valve disc, allowing for smooth actuation of the valve 120. The stabilizers 158 can also provide frictional engagement with the interior of the catheter hub 102 to prevent the actuator 122 from sliding proximally after the luer cone is removed. However, as discussed above, protrusions 154 may be included in the valve actuator 122 to engage an internal collar or abutment 176c within the catheter hub 102 to retain the valve actuator 122 within the catheter hub.

In one embodiment, the nose portion 150 is configured to remain engaged with the disk 121 of the valve 120 after the valve has been actuated and after the luer cone has been removed. For example, the nose portion 150 may be wedged between one or more slots on the valve disk and held there by friction. The valve actuator 122, such as the nose 150, may be provided with surface features, such as ridges, grooves, or serrations, to maintain engagement between the actuator 122 and the valve 120 after actuation and after the luer cone is removed. In a preferred embodiment, the valve actuator 122 does not engage the valve 120 after the tip of the luer cone is removed. In a preferred embodiment, the valve actuator can be moved from a distal position, pressed against the valve, to a proximal position, away from or minimally touching the valve, but allowing the valve flaps to return or close the slots. When the valve actuator returns to the proximal position after removal of the luer cone, the valve may close to prevent or restrict fluid flow through the valve. The valve may reopen if the valve actuator 122 is moved distally by a pin-type medical instrument, such as a syringe tip or an infusion set tip.

At least one relief, opening, or passageway 160 is provided between the transition portion of the valve actuator 122 and the proximal end of the valve actuator. The transition portion may be understood to be a portion proximal to the distal end of the valve actuator, or from the nose to the two stabilizers. In one example, two reliefs or through passages 160 are provided to provide clearance such that the inner or central portion of the valve actuator 122 and the inner surface of the catheter hub 102 can be in open communication. In other words, between the continuous nose portion and the continuous perimeter portion defined by the two stabilizers 158 and the plunger elements 152, called the stabilizer ring 162, are one or two reliefs, through passages, or openings 160 for fluid flow, such as flushing. Through holes or reliefs can also be used to support the needle safety mechanism, as discussed in more detail below.

The stabilizing ring 162 of the valve actuator 122 may have an inner diameter that is smaller than the diameter defined by the diagonal portion or corner members of the two tabs of the needle guard mechanism 130 when the two tabs are spread apart by the side surface of the needle shaft in a ready-to-use position. Thus, during installation of the needle guard 130 into the valve actuator holding space, the diagonal portion or rectangular bends of the needle guard 130 may move to pass through the stabilizing ring 162 into open areas defined by the reliefs or through holes 160.

When the needle tip guard 130 is positioned between the two plunger elements 152, the two distal walls of the needle guard 130, more specifically the two folded or corner members of the needle guard, may be positioned in the reliefs 160, as discussed above, to contact the guard's contact surface with the inner surface of the catheter sleeve. This allows the needle guard mechanism 130 to protrude from the retaining space of the valve actuator 122 through the two reliefs 160 to come into contact with the catheter hub guard contact surface. Thus, the needle guard can be held within the catheter hub in the ready-to-use position and during needle retraction after successful venipuncture until the needle tip has moved proximal to the two distal walls of the needle guard, at which time the needle guard can close. over the tip of the needle, the distal end of the needle guard mechanism 130 becomes smaller in diameter than the inner diameter of the valve hole in the stabilizing rings 162 and can be removed along with the needle.

An annular groove or groove may be provided in the interior cavity of the catheter hub 102 to accommodate two folded or angled portions of the needle guard mechanism. Thus, during retraction of the needle after successful venipuncture, the needle guard mechanism 130 can be prevented from sliding proximally by the collar of the annular groove or some other feature of the topography of the inner surface of the catheter hub, such as a safety engagement surface on the inner surface of the catheter hub. Optionally or alternatively, the distal edge of one or both stabilizers 158 may provide a holding surface to prevent premature activation of the needle guard 130 during retraction before the tip of the needle has moved proximally away from the two distal walls of the needle guard. In addition to a distal edge, each stabilizer 158 may have a proximal edge. When the needle guard 130 is held by one or both of the distal edges of the stabilizers 158, the inner surface of the catheter hub 102 may lack an engaging member or members to accommodate the corner members in the needle guard. In one example, the needle guard mechanism 130 may engage one or both distal edges of two stabilizers 158, and may engage an engaging member or features formed within the catheter hub, such as a groove, edge, or collar.

In some examples, one or both stabilizer elements 158 may have a slot or channel, thereby dividing the arcuate stabilizer element or stabilizer element into two segments. Even if there is a slot on one or both of the stabilizer members 158, the stabilizer ring 162, which may not be a solid ring like a ring with one or more slots extending through the ring, can still provide a holding structure for engagement with the two corner members to prevent early activation of the needle safety mechanism 130 during needle retraction before the needle tip moves proximally from the two distal walls.

The retaining surfaces of the stabilizer elements, such as the distal edges, may be referred to as a stop end, stop gap, or stop end because they provide a rigid structure that prevents the needle guard from moving proximally unless or until the needle guard is first is activated and will not collapse radially to reduce its cross-section and then slide proximally away from the locking end. In one example, one or two corner members of the needle guard may be restrained by the stop end from moving in a proximal direction until one or two rectangular bends of the needle guard converge to reduce the cross-section of the needle guard. In one example, when the cross-section of the needle guard mechanism is reduced, the needle guard mechanism may slide through the channel defined by the stabilizing ring 162 from the distal end of the stabilizing ring to the proximal end of the stabilizing ring.

The valve actuator 122 may be made of a metallic material or a plastic material. If the valve actuator 122 is made of a metallic material, it may be made by bending or deep-drawing methods, and the arcuate cross-section of the plunger element 152 may provide additional rigidity when pressed against the luer cone. Each plunger element 152 may include at least two longitudinal edges, and a rib may be provided along one or both longitudinal edges to provide additional structural rigidity. One or more gaps may be provided between any two plunger elements 152. The gaps may provide a gap or space for fluid to flow through them, for example, during blood flushing or intravenous infusion. The gap between the plunger elements 152 may define a holding space to accommodate the needle tip guard mechanism 122.

In some embodiments, most, if not all, of the needle tip guard 130 fits in the space defined by the actuator body 122 between the two plunger elements 152 in the ready-to-use position, as will be discussed in more detail below. This allows the catheter hub 102 to be made more compact, since less longitudinal space is required within the hub to accommodate the valve actuator 122 and the needle tip protector 130 in series in the longitudinal direction or when they only partially overlap in the axial direction.

When the needle tip protector 130 engages only the distal edge of the relief or through passage 160 in the actuator 122, then no deformation or change in diameter of the inner wall of the catheter hub is required, and the needle tip protector 130 can be positioned proximally in the tapered portion of the Luer cannula at compliance with the international Luer standard for conical fittings, and the overall length of the catheter hub 102 can be further reduced.

The exemplary valve 120 shown in accordance with embodiments of the present invention can be used with the catheter assemblies and Luer cannula hubs described herein. In fig. 3 and further in Fig. 4, which shows the catheter assembly or needle assembly 100 of FIGS. 1-3 in longitudinal section, the illustrated valve 120 may have a first portion 168 of a first thickness and a second portion 170 of a second thickness that is less than the first thickness measured orthogonally. medial plane passing through the diameter of the valve. The second second thickness portion 170 may have a substantially constant thickness, but may further include a variable thickness along the cross section of the valve on the second portion.

In one example, the second portion 170 is formed by recessing the distally facing surface of the valve, the proximally facing surface of the valve, or both surfaces, while the first portion 168 retains substantially the entire width or thickness of the valve between the proximal and distal facing surfaces. In one example, the recesses on the second portion 170 may be undercuts formed in the valve. As shown in FIG. 3, the surface between the first and second portions 168, 170 may resemble a three-leaf clover. The three-leaf clover may be present on the distal facing surface, the proximal facing surface, or both surfaces of the valve 120. In other examples, the appearance of the proximal and/or distal facing surfaces may have different contours, such that the three-leaf clover may have contours with different curves, lines, and edges . In one example, slits are formed through the thinner second valve portion 170 to form valve flaps between adjacent valve slits. In some examples, there may be two or more slots defining one or more valve flaps. For example, the first and second portions 168, 170 of valve 120 may define a four-leaf clover, which may have four slots and four valve flaps. In a preferred design, the valve may have three slots and three valve flaps. The slots may begin approximately at the center of the valve and extend radially outward toward, but not all the way to, the outer perimeter of the valve. The length of each slot can be varied to form valve flaps of different sizes. The length of the slots may be selected to provide the desired valve flaps and deflect the valve flaps when pressed by the nose portion 150 of the valve actuator 122, for example, when pressed by the driving distal end of the valve actuator 122.

Valve 120 may be integrally molded from a single material. In an alternative embodiment, the valve 120 may be made of different materials in different parts of the valve 120 for reasons such as improved rigidity or flexibility. The valve can be made from medical grade elastomer or thermoplastic elastomer (TPE). These and other embodiments of valve 120 may be implemented in accordance with the valve examples disclosed in PCT Application No. PCT/EP2017/070934, published as PCT Publication No. WO 2018/033626 A1, the contents of which are expressly incorporated herein by reference in in full.

In the present embodiment, the locking device 124 is a holding ring that has an annular wall structure with an outer surface and an inner surface defining a channel. In other embodiments, the locking device for securing the valve within the catheter hub may be a retaining skirt, an O-ring, or a spring. Valve 120, valve actuator 122, and locking device 124 may have different shapes, styles, and characteristics but otherwise perform the functions described herein. Valve 120 may be a valve disk, as previously described, having at least one slot defining at least two flaps. As shown, the valve disc may have three (as shown) or more slots defining three or more flaps, and the surface of the disc may have varying surface characteristics and thicknesses along a cross section of the valve disc. In other examples, the valve may have a valve disc and a skirt extending proximally from a proximally facing surface of the valve disc.

In fig. 4 is a partial cross-sectional view of a catheter assembly or needle device 100, which may be the catheter assembly of FIG. 3. The catheter assembly 100 is shown without the needle portion 108, catheter tube 104, and needle hub 106, and without the vent plug typically located in the proximal hole of the needle hub. The catheter hub 102 is shown with valve 120, valve actuator 122, locking device 124, and needle guard 130 located within an internal cavity 123 of the hub body 126, which may be a single hub body with a distal end from which the catheter tube extends and a proximal opening with a cannula. Luera. As shown, the valve 120 is located distal to the locking device 124, a portion of the valve actuator 122 is located in the opening of the locking device 124, and the needle protection mechanism 130 is located in the holding space 174 of the valve actuator 122.

In one example, the interior of the catheter hub 102 is provided with one or more beads or projections 176a, 176b, 176c, which can be understood as a structural edge or stop formed on the wall of the interior surface. One or more collars 176 may provide engagement or abutment points for components housed in the internal cavity 123 to prevent the components from moving or being pushed out of the interior of the catheter hub. As shown, the valve 120 may be positioned in the annular groove and may abut against one of the collars 176a to prevent proximal movement of the valve 120. As shown, the valve 120 also abuts against the collar 173 (FIG. 5) of the catheter hub 102 on the distal side of the valve to preventing distal displacement of the outer perimeter of the valve.

A locking device or retaining ring 124 in the form of an annular gap is located adjacent the valve 120 and abuts at the proximal end of the locking device against another collar 176 b in the internal cavity 123 of the catheter hub to prevent proximal movement of the locking device 124. As shown, the locking device 124 has a cross-section shaped like a ramp, triangle, or sloping surface with a high portion of the ramp at the distal location and tapering as it moves proximally. The fixation device 124 may be made from medical grade plastic, such as by plastic injection. In other examples, the locking device may be made from a metallic material, such as by stamping and then forging, pressing, or machining. In other examples, the locking device 124 may be made of an elastomeric material, such as an O-ring, to provide a proximally directed valve actuator force upon compression, deformation, or displacement between the valve actuator nose portion 150 and the inner wall of the catheter hub in a distal position.

The distal end of the locking device 124, the high portion of the ramp, is adjacent to the proximally facing surface of the valve 120, and the proximal end of the locking device 124, the narrow portion of the ramp, is adjacent to one of the collars 176 b of the internal cavity 123. This arrangement of the locking device 124 may help retain the valve 120 from proximal displacement within the catheter hub. In some examples, valve 124 may be secured or supported within the catheter hub by a locking device without the use of a separate collar 176 adjacent the proximal edge of the valve. In one example, the locking device 124 may have slight engagement upon first entry into the proximal open end of the catheter hub and may have a fit or slight engagement with the catheter hub in the end position shown. In other examples, the locking device 124 may be retained within the catheter hub and secure the valve 120 from proximal displacement using only an interference fit on the catheter hub without a separate collar adjacent the proximal end of the locking device.

The locking device may be a retaining ring 124, typically having a triangular cross-section as shown in the figure. In other examples, the cross section may have a different shape. As will be described below, the retaining ring 124 or locking device may also function as a return mechanism to assist the valve actuator 122 to return or move from a distal to a proximal position. For example, when the valve actuator 122 is advanced by the Luer cone to open the slots of the valve 120, the retaining ring 124 may help return the valve actuator to the proximal position after the Luer cone is removed from the proximal opening of the catheter hub. In some examples, the locking device 124 only locks the valve from proximal movement while the elasticity of the valve returns the valve actuator from the distal to the proximal position. In some examples, the cross-section of the locking device may have a shape other than triangular. In other examples, the cross-section of the retaining ring 124 may be formed as a retaining skirt and form part of a valve. For example, valve 120 may be formed as either a valve disk or a retaining skirt, such as by bonding or integral molding.

In the example shown, the length of the valve actuator 122 is selected such that the actuator end 180 at the distal end of the nose portion 150 simply contacts the valve disc, and the proximal edges 182 of the two plunger elements 152 simply contact the nose portion 184 of the needle hub 106. In other examples, drive end 180 may be slightly away from the valve disc or slightly pressed against the valve disc, but not significantly deflect the valve flaps to allow the valve flaps to close the valve slots. It should be noted that the valve leaflets are slightly deflected distally due to the presence of the needle.

In one example, the space 174 for holding the valve actuator 122 is sized and shaped to accommodate a needle guard mechanism 130. In fig. 4 and 5, which show the needle device 100 of FIG. 4, rotated 90 degrees, the needle protection mechanism 130 is located between two plunger elements 152 of the valve actuator 122. The needle guard mechanism 130, which has a proximal wall 140 and two rectangular bends 188, 190 located distal to the proximal wall 140, is located in the holding space 174 of the valve actuator 122 with two corner elements 188 a, 190 a of the needle guard mechanism 130 located distal to the two stabilizing members 158. The corner portions are located between the distal walls 188b, 190b and the elongated portions of the legs. If the needle 108 is retracted proximally, the two corner members 188a, 190a will be stopped from moving proximally past the two distal edges 158a, 158a of the two stabilizing members 158, which act as a stopper end. As described previously, the transverse dimension of the needle guard mechanism at the two corner portions 188a, 190a is greater than the internal dimension of the stabilizing ring 162 and is therefore physically stopped by the distal edges of the two stabilizing elements 158. After successful venipuncture, the needle is withdrawn from the catheter tube and catheter hub. , and the needle tip moves proximally away from the two distal needle guard walls 188 b, 190 b, allowing the two needle guard arms 188, 190 to move inward or collapse to reduce the lateral dimension near the two corner members. At approximately the same time, the change in profile 142 (FIG. 2) near the tip of the needle abuts the perimeter defining the opening 192 at the proximal wall of the needle guard 140, and further retraction of the needle results in the removal of the needle guard 130 along with the needle 108.

In one example, the interior of the catheter hub 102 is enlarged at a location adjacent to two corner members 188a, 190a. For example, the inner diameter of the catheter hub at about two right angle bends is larger than the inner diameter of the catheter hub at the proximal wall 140 of the catheter hub. This space can be attached to provide relief or additional space for the needle safety mechanism in the ready position. That is, the relief, when provided, provides space for the two tabs 188, 190 such that the two tabs do not compress or converge around the two corner members 188a, 190a in the ready-to-use position to the same extent as compared to , when the relief is not provided. This can reduce the resistance between the needle shaft and the two curved ends at the ends of the two distal walls 188 b, 190 b during retraction of the needle after injection.

From fig. 4, the valve actuator 122 can be retained in the internal cavity 123 of the catheter hub 102 and prevented from exiting the proximal opening 136 by providing at least one side projection 154 on the valve actuator to engage one of the shoulders 176 in the internal cavity 123. Transverse the cross-section of the valve actuator extending across at least one protrusion 154 is greater than the cross-section extending along the shoulder of the catheter hub 102, thereby providing a physical stop to prevent proximal movement of the valve actuator 122 from the proximal opening 136 of the catheter hub. As shown, if the valve actuator 122 moves proximally, for example, due to the needle guard corner members 188a, 190a exerting proximal pressure on the distal edges 158a of the two stabilizing members 158 during retraction of the needle, but before Once the needle tip moves proximally away from the two distal walls, the overall proximal movement may be limited by the projection 154 abutting the shoulder 176 c. In one example, two projections 154 may be provided on valve actuator 122, one on each actuator 158, to engage collar 176c, which may be in an annular configuration.

In fig. 6 is a cross-sectional side view of the needle assembly 100 of FIG. 4 and 5, in which the needle 108, needle guard 130, and needle hub 106 are removed from the catheter tube 104 and catheter hub 102, for example, after successful venipuncture and the catheter tube 104 in the patient's vein. As shown, the needle guard 130 was removed along with the needle 108 in the manner described above. Once the needle 108 is withdrawn, the plurality of valve flaps 194 are allowed to retract or return to a relaxed state to close the slots 196 and restrict proximal and distal flow through the valve 120. In the illustrated condition, the actuator end 180 on the nose portion 150 of the valve actuator 122 is located within the channel, specified by the locking device 124, but at a distance from or not in contact with the locking device 124. The conical surface of the nose portion 150 is also spaced from the locking device 124. This distance or clearance allows the valve actuator 122 to move forward in a distal direction when pushed by the distal end of the luer cone before it reaches or contacts the locking device 124. In some examples, the distal end of the Luer taper abuts the Luer cannula of the catheter hub to stop further distal advancement of the distal end of the Luer taper into the catheter hub before the valve actuator nose portion 150 contacts or is pressed against the interior of the locking device 124. The actuator end 180 is shown in contact with the proximally facing surface of the valve 120. In other examples, the driving end 180 may be spaced from the proximally facing surface of the valve 120. The driving end 180 may be spaced from the valve by a distance approximately the same as the clearance between the projections 154 on the valve actuator 122 and the collar within the sleeve 102 catheters.

As shown, the nose portion 150 of the valve actuator 122 is increasingly tapered in the proximal direction and is spaced from the tapered surface with a ramp cross-section 198 of the locking device 124. The nose portion 150 may be positioned to be sized and shaped to contact the locking device 124 ramp cross-section 198 or be located at a distance from it. In one example, the nose portion 150 may include an elastic portion or band, such as an elastomeric band, band or strips, and may provide a slight obstruction when the valve actuator 122 is advanced distally to open the valve 120 and the nose portion contacts the locking device, as in more detail. is described below with reference to FIG. 7. If the longitudinal axis of the catheter hub 102 is considered the X-axis, and the Y-axis is orthogonal to the X-axis, then the shape of the nasal portion 150 is selected to deflect the valve leaflets 194 in the distal direction, and also to create force vectors that have both an X component, as well as a Y component. Force vectors acting in the X direction, a force vector with an X component, or a proximally directed force vector can be used to facilitate the return of the valve actuator 102 from a distal position in which the actuator end 180 is pushed into the interior of the valve 120 to deflect the leaflets. 194 valves, to the proximal position, as shown in the figure. As will be discussed in more detail below, the valve leaflets 120, or both the valve leaflets and the locking device 124, can generate force vectors directed against the nose portion 150 of the valve actuator 122 to return the valve actuator from a distal position to a proximal position. In other examples, a valve part or parts other than the valve leaflets may provide a proximally directed force to move the valve from a distal position to a proximal position.

In one example, the area or portion within the catheter hub 102 adjacent the open proximal end 136 is a Luer cannula 204, which is intended to have a structure formed in accordance with ISO standards for Luer cannulas. The proximal edges 182 of the two plunger elements 152, 152 of the valve actuator 122 are shown recessed from the proximal open end 136 of the catheter hub 102, but located within the Luer cannula 204. Thus, when the tip of the Luer cone is inserted into the Luer cannula, the tip of the Luer cone will push the two plunger elements 152 in a distal direction to cause the valve actuator 122 to push the valve 120 to open the valve, as described in more detail below.

In fig. 7 is a cross-sectional side view of FIG. 6 with a Luer cone 200 inserted into the open proximal end 136 and advancing the valve actuator 122 into the valve 120 to open the valve leaflets 194 and fluid communication between the Luer cone 200 and the lumen of the catheter tubing 104. In practice, the Luer cone tip 200 may be the tip of a syringe or the pin tip of an IV or IV set attached to an IV bag. In the configuration of FIG. 7, fluids can be withdrawn or aspirated from the catheter hub 102 in a proximal direction or infused through the catheter tubing in a distal direction. Although not shown, the Luer cone tip 200 may have a threaded ring for engagement with lugs or external threads 202 on the catheter hub 102 to further hold the valve actuator 122 in a distal position to open the valve 120.

In one example, the valve actuator 122 is configured to be distally moved by the Luer tip 200. The amount or distance that the valve actuator 122 moves distally must be sufficient to cause the actuator end 180 and nose portion 150 to deflect the valve flaps 194 distally to open the slots of the valve 120 and thereby open fluid communication between with a 200 Luer cone tip and a 104 catheter tube. In the example shown, the drive end 180 of the valve actuator 122 is moved distal to the valve leaflets, and the valve leaflets are compressed between the interior of the catheter hub 102 and the conical surface of the nose portion 150, or the valve leaflets are deflected or deformed distally by the nose of the valve actuator, with or without compression. In other examples, the drive end 180 moves a distance equal to or less than the ends of the valve leaflets 194, but still opens the valve leaflets to allow free flow in the proximal and distal directions.

When the Luer cone 200 is removed, for example, when replacing an intravenous fluid bag attached to the Luer cone 200, the action of the distally directed force on the proximal edges 182 of the two plunger elements 152 on the side of the Luer cone 200 is removed or stopped, and the Luer cannula 204 is not occupied by any external object. This allows the valve actuator 122 to return to its proximal position, now vacated by the luer cone. In one example, the elasticity of the valve 120 allows the valve flaps 194 to move back to a more relaxed state, such as the position shown in FIG. 6. This returning action of the valve flaps 194 and the shape of the nose portion 150 of the valve actuator 122 allow the valve flaps to apply force vectors to the nose portion 150 to cause the valve actuator 122 to move from the distal position shown in FIG. 7 to a proximal position, as shown in FIG. 6. The force vectors generated by each of the valve leaflets 194 on the nose portion 150 of the valve 122 actuator as the valve leaflets retract rearward include a force component that is generally parallel to the longitudinal axis of the catheter hub, also referred to herein as an X-component force vector or proximally directed vector of force. Thus, the X-component force vector generated by the valve leaflets may cause the valve actuator 122 to move from a distal position, in which the actuator end 180 and nose portion 150 deflect the valve leaflets distally to open the valve, to a proximal position, in which the actuator the end and nose no longer deflect the valve flaps. In some examples, the nose portion 150 of the valve actuator 122 is contoured, such as with distinct lines or curves, by forming recesses in the nose portion with distinct contour lines or curves. One or more surfaces of the contoured nose portion may then be applied to press against the valve 120. The valve may be pressed to create a plurality of compression points or displacement points. For example, the contoured nose piece may be configured to compress the valve leaflets, or the valve actuator may deflect the valve leaflets distally so that the valve leaflets can in turn create force vectors against the nose piece when the Luer cone is removed and the valve leaflets return into a relaxed state. The contoured nose portion may also axially compress, deform, or displace the valve portion or portions relative to the distal shoulder such that the valve produces an opposing axially restoring force when the luer cone is withdrawn, as will be described below, for example, with reference to FIGS. 31-32B. Thus Thus, the valve itself may push the valve actuator in a proximal direction upon removal of the luer taper as the valve returns back after being compressed, deformed, displaced, or deflected by only the contoured nose portion or multiple point portions of the contoured nose portion.

In some examples, the contact interaction between the ramp-shaped section 198 of the locking device 124 and the nose portion 150 results in the creation of force vectors on the nose portion 150 of the valve actuator 122 that include an X-component force vector. For example, the valve actuator may include an elastic band or one or more elastic strips that are compressed or displaced by the locking device as the nose portion is pushed by the luer cone into the locking device. Thus, in addition to the return force generated by the valve flaps 120 on the nose 150 of the valve actuator 122, the gap between the locking device 124 and the nose 150 of the valve actuator creates a return force and promotes proximal movement of the valve actuator 122 from the distal position where the drive end and the nose portion deflects the valve leaflets distally, to a proximal position where the drive end and nose portion no longer deflect the valve leaflets. In the proximal position, the valve actuator 122 is located within the catheter hub as generally shown in FIG. 6, which shows the valve flaps generally closing the slits so as to stop or restrict the flow of fluid in a proximal direction and/or a distal direction. In some examples, the nose portion may be provided with a recess and an elastomeric strip or plate is placed into the recess to create a valve actuator with a rigid portion and a more ductile portion. In other examples, the nose portion is molded or inserted into a mold along with an elastomeric strip or plate. An elastomeric strip or plate integrated with the nose portion may allow the valve actuator to be pressed against the rigid portion or component of the locking device to provide a restoring force after removal of the luer cone.

Thus, it is understood that objects of the invention include a catheter assembly or needle device including a catheter hub with a catheter tube extending in a distal direction, the catheter hub including a body having an outer surface and an inner surface defining an internal cavity. A valve and a valve actuator may be located in the internal cavity. In one example, a locking device with an orifice defining body is located proximal to the valve. The valve leaflets can provide a proximally directed restoring force to return the valve actuator from a distal position to a proximal position. Additionally or alternatively, the valve may be compressed or axially displaced relative to the distal shoulder and valve, providing an axially directed force against the nose to return the valve actuator when the luer cone is removed. In one example, the locking device may provide contact interaction with a valve actuator, such as an elastomeric portion of the valve actuator, when the valve actuator is advanced distally by a luer cone to open the valve leaflets, wherein the contact interaction may generate force vectors including a force vector that is generally directed parallel to the longitudinal axis of the catheter hub to return the valve actuator from the distal position to the proximal position when the Luer cone is removed from the catheter hub. In other examples, the nose portion is spaced from the locking device or is not adjacent to the locking device and the return force is provided by the valve alone. The locking device may further provide the function of locking the valve within the catheter hub and preventing inadvertent proximal displacement of the valve and its removal from the catheter hub. The catheter hub may include a needle extending through the catheter hub, a valve, a valve actuator, a locking device, and a catheter tubing. The needle may be connected to a needle hub at the proximal end of the needle.

Because the valve actuator can move to a distal position into the valve, such as when pushed by a luer cone to open two or more valve leaflets, and can return to a proximal position when the luer cone is removed to allow the valve leaflets to relax or close to close the slots , the valve may go through several actuation cycles. In one example, the valve may undergo two or more actuation cycles. For example, the valve may undergo at least three cycles, at least four cycles, at least five cycles, or more. Each actuation cycle may include movement of the valve actuator into the valve to deflect the valve flaps and movement away from the valve.

Next, with reference to FIG. 8 and 9, a catheter assembly or needle assembly 100 in accordance with other aspects of the invention is shown with the needle and needle hub removed, but may have the same needle and needle hub as described elsewhere herein. The needle assembly 100 may also include a needle guard as described elsewhere herein.

In the present embodiment, the catheter hub 102, catheter tube 104, valve 120, valve actuator 122, and locking device 124 may be similar to those shown with reference to FIGS. 6 and 7, with some exceptions. In the present embodiment, an annular slot or annular channel 206 is provided on the proximal surface of the valve 120. As shown in the figure, the annular slot 206 is recessed from the outer perimeter of the valve. An annular slot 206 may be provided on the first valve portion 168 (FIG. 3), which is a thicker valve portion than the second valve portion 170. An annular slot 206 may be provided to receive the distal end of the locking device 124, as described in more detail below.

In the present embodiment, the locking device 124 is a retaining ring having a distal end 210 that projects into the annular slot 206. In one example, the distal end 210 of the locking device 124 is pushed into the annular slot 206 and is held therein by compression or contact interaction . In other examples, the locking device may be held in the annular slot 206 by adhesive or bonding. In other examples, the annular slot 206 is an annular channel and does not engage the locking device on either the inner or outer surfaces of the locking device. For example, the outer surface of the locking device 124 may press against the annular channel, but is spaced from the annular channel along the inner surface of the locking device. This alternative configuration allows the locking device 124 to press the valve 120 outwardly against the catheter hub without having to engage the annular slot with both the inner and outer surface of the distal end of the locking device.

The retaining ring 124 of the present embodiment may have a wall with a length between the proximal and distal ends and a curved body portion of constant wall thickness at the proximal end of the retaining ring. The wall has an interior portion that defines an opening to receive the nose portion 150 of the valve 122 actuator. The wall of the locking device 124 may be generally cylindrical except at the proximal end. In one example, the proximal end 212 of the retaining ring 124 may have an outwardly curved edge 214 to secure the retaining ring 124 to the inner collar 176b of the catheter hub 102. Once positioned against the inner collar 176b, the locking device 124 may help protect the valve 120 from proximal movement. The valve 120 is protected or restrained from distal movement by being positioned directly against the collar 173 (FIG. 5) of the catheter hub 102 by the distally facing surface of the valve.

The locking device 124 and the nose portion 150 of the valve actuator 122 are spaced apart in the proximal position of FIG. 8 valve actuators. The clearance or distance therebetween provides play for the valve actuator 122 to move distally to open the valve, such as to deflect the valve flaps, before contacting or impinging on the locking device 124. In the illustrated condition, the drive end 180 on the nose 150 of the valve actuator 122 is located within the opening. , specified by the locking device 124, but at a distance from the locking device 124, that is, without contact with it. The conical surface of the nose is also at a distance from the locking device. This distance or play allows the actuator valve element to move forward in a distal direction before impinging or contacting the locking device. The driving end 180 is shown in contact with the proximally facing surface of the valve 120. In other examples, the driving end may be slightly spaced from the proximally facing surface of the valve.

In fig. 9 is a cross-sectional side view of the assembly of FIG. 8 with a Luer taper 200 inserted into the open proximal end 136 and advancing a valve actuator 122 into the interior of the valve 120 to open the valve leaflets 194 and fluid communication between the Luer taper 200 and the lumen of the catheter tubing 104, similar to the embodiment of FIG. 7. Although not shown, the luer cone 200 may have a threaded ring for engagement with the lugs or an external thread 202 on the catheter hub 102 to assist in holding the valve actuator 122 in a distal position to open the valve 120.

In one example, the valve actuator 122 is configured to move distally as the luer cone 200 advances. The distance that the valve actuator moves distally must be sufficient to cause the actuator end 180 and nose portion 150 to deflect the valve flaps 194 distally to open the slots and thereby open fluid communication between the luer cone 200 and the tube. 104 catheters. In the example shown, the drive end 180 of the valve actuator 122 is moved distal to the valve leaflets, and the valve leaflets are compressed between the interior of the catheter hub 102 and the conical surface of the nose portion 150, or are deflected or deformed distally by the nose of the valve actuator, with or without compression. As shown, drive end 180 moves a distance equal to or shorter than the ends of the valve flaps while still opening the valve sufficiently for free flow in both directions.

In the example shown, the curved edge 214 acts as a biasing element. Thus, when the nose portion 150 is pressed against the curved edge 214 at the proximal end of the locking device, the curved edge 214 presses against the nose portion, such as an elastomeric strip, plate, or section embedded in the nose portion, and creates a pair of force components or force vectors on the nose portion. a valve actuator portion 150 that includes a force acting generally parallel to the longitudinal axis of the catheter hub 102. In other examples, the nose portion is away from the locking device when the Luer cone contacts the Luer cannula of the catheter hub. In this case, the valve can provide the restoring force necessary to return the valve actuator from the distal to the proximal position.

When the Luer cone 200 is removed, for example, when replacing an intravenous fluid bag attached to the Luer cone 200, the distally directed force acting on the proximal edges 182 of the two plunger elements 152 on the side of the Luer cone 200 is removed or eliminated, and the Luer cannula 204 turns out to be unoccupied by an external object. This allows the valve actuator 122 to return to its proximal position, now vacated by the luer cone. In one example, the elasticity of the valve 120 allows the valve flaps 194 to return to a more relaxed state, such as the position shown in FIG. 8. This returning action of the valve leaflets 194 and the shape of the valve actuator nose 150 allow the valve leaflets to apply force vectors to the nose 150 to cause the valve actuator 122 to move from the distal position shown in FIG. 9 to the proximal position as shown in FIG. fig. 8.

Therefore, it is understood that the objects of the invention include a catheter assembly or needle device including a catheter hub with a catheter tube extending in a distal direction, the catheter hub including a body having an outer surface and an inner surface defining an internal cavity. A valve and a valve actuator may be located in the internal cavity. In one example, a locking device with an orifice defining body is positioned proximal to the valve and locks the valve within the catheter hub. In one example, the locking device engages the valve actuator as the valve actuator is advanced distally by the luer cone. In another example, the Luer cone abuts the Luer cannula of the catheter hub before the nose of the valve actuator contacts the locking device. The valve drive is configured to open the valve flaps. In one example, the contact interaction, deflection, displacement, or compression caused by the action of the valve actuator on the valve leaflets creates a store of energy providing force vectors, including a force vector that is directed generally parallel to the longitudinal axis of the catheter hub to return the valve actuator from a distal position to a proximal position when the Luer cone is removed from the catheter hub. The locking device may also apply a restoring force to the nose portion, such as an area of the nose piece with a plastic insert, elastic plate, or valve actuator material, to provide additional proximally directed restoring force. The locking device may further provide a locking function to secure the valve within the catheter hub and prevent inadvertent proximal displacement of the valve to exit the catheter hub. The catheter hub may include a needle extending through the catheter hub, a valve, a valve actuator, a locking device, and a catheter tubing. The needle may be attached to a needle hub at the proximal end of the needle.

Because the valve actuator can move to a distal position into the valve, such as when pushed by a luer cone to open two or more valve leaflets, and can return to a proximal position when the luer cone is removed to allow the valve leaflets to relax or close to close the slots , the valve may go through several actuation cycles. In one example, the valve may undergo two or more actuation cycles. For example, the valve may undergo at least three cycles, at least four cycles, at least five cycles, or more. Each actuation cycle may include movement of the valve actuator into the valve to deflect the valve flaps and movement away from the valve.

Now with reference to FIG. 10 and 11, a catheter or needle assembly 100 in accordance with still other aspects of the invention is shown with the needle and needle hub removed, but may have the same needle and needle hub as described elsewhere herein. The needle assembly 100 may also include a needle guard mechanism 130, as described elsewhere herein.

In the present embodiment, the catheter hub 102, catheter tube 104, valve 120, valve actuator 122, and locking device 124 may be similar to those shown with reference to FIG. 6-9, with some exceptions. In the present embodiment, the retaining device 124 is a retaining ring having a distal end 210 with an outwardly curved edge defining a flange 216 for abutment or contact with the proximally facing surface of the valve 120, and a wall or body tapering from a first dimension to a second, larger dimension. in the proximal direction. Thus, the wall of the present embodiment resembles a ramp with a high portion of the ramp at the distal location and becomes narrower as it moves proximally. The present locking device 124 has a ramp or inclined surface similar to that shown in FIG. 6 and 7, but without the same continuous section.

The proximal end 212 of the locking device includes a proximal edge 218 that may be sized to abut or press against the inner collar 176 b of the catheter hub 102. By positioning against the inner collar 176 b, the locking device 124 can help secure the valve from proximal movement. In an alternative embodiment, there is no need for a collar to secure the locking device 124 in the internal space if there is a slight interference fit between the proximal end 212 and/or the distal end of the locking device and the inner diameter of the catheter hub 102. The valve 120 is fixed or held distally by positioning against the collar 173 (FIG. 5) with the distal facing surface of the valve.

The locking device 124 and the nose portion 150 of the valve actuator 122 are spaced apart at the proximal position of the valve actuator in FIG. 10. The clearance or distance therebetween provides play to allow valve actuator 122 to move distally to open the valve, such as to deflect valve leaflets, before clearance, contact, or collision with the locking device 124. In the illustrated condition, drive end 180 on actuator nose 150 The valve 122 is located within the opening defined by the locking device 124, but at a distance from, that is, without contact with, the locking device 124. The conical surface of the nose is also at a distance from the locking device. This distance or clearance allows the valve actuator 122 to move forward in a distal direction before it impacts or contacts the locking device 124. The valve actuator driving end 180 is shown in contact with the proximally facing surface of the valve 120. In other examples, the driving end may be slightly away from the proximally facing surface of the valve.

In fig. 11 is a cross-sectional side view of the assembly of FIG. 10 with a Luer cone 200 inserted into the open proximal end 136 and advancing a valve actuator 122 into the interior of the valve 120 to open the valve leaflets 194 and fluid communication between the Luer cone 200 and the lumen of the catheter tubing 104, similar to the embodiment of FIG. 7 and 9. Although not shown, the luer cone 200 may have a threaded ring to engage lugs or external threads 202 on the catheter hub to hold the valve actuator in a distal position to open the valve.

In one example, the valve actuator 122 is configured to move distally as the luer cone 200 advances. The distance that the valve actuator moves distally must be sufficient to cause the actuator end 180 and nose portion to deflect the valve flaps 194 distally to open the slots and thereby fluid communication between the Luer cone 200 and the catheter tube 104 . In the example shown, the drive end 180 of the valve actuator 122 is moved distal to the valve leaflets, with the valve leaflets being compressed between the interior cavity of the catheter hub and the conical surface of the nose portion 150, or the valve leaflets being deflected or deformed distally by the nose of the valve actuator, with or without compression. In some examples, the nose portion of the valve actuator is contoured, such as with distinct lines, by forming recesses in the nose portion with distinct contour lines or curves. One or more surfaces of the contoured nose piece can then be used to press against the valve and retract the valve to push the contoured nose piece in a proximal direction to return the valve actuator to the proximal position. For example, one or more contoured surfaces may axially compress, deform, or displace the valve relative to the distal shoulder such that the valve provides an axially directed restoring force upon removal of the luer cone. In some examples, the drive end 180 moves a distance equal to the ends of the valve flaps or shorter than the ends of the valve flaps than the ends of the valve flaps, but the valve is opened sufficiently to allow free flow in both directions.

In the example shown, the ramp acts as a displacement element. For example, when the nose portion 150 is pressed against the ramp of the locking device 124 by the luer cone, the locking device applies an opposing biasing force to the actuator nose 150, such as a plastic portion located on the nose. Thus, when the nose portion 150 is pressed against the ramp in contact interaction, the locking device ramp 124 applies a pair of force components or force vectors to the nose portion, which includes a force acting generally parallel to the longitudinal axis of the catheter hub. In some examples, the nose portion is positioned away from the locking device when the Luer cone abuts the Luer cannula of the catheter hub.

When the Luer cone 200 is removed, for example, when replacing an intravenous fluid bag attached to the Luer cone 200, the action of a distally directed force on the proximal edges 182 of the two plunger elements 152 on the side of the Luer cone 200 is eliminated or terminated, and the Luer cannula 204 not occupied by any external object. This allows the valve actuator 122 to return to its proximal position, now vacated by the luer cone. In one example, the elasticity of the valve 120 allows the valve flaps 194 to return to a more relaxed state, such as the position shown in FIG. 10. This outward action of the valve blades 194 and the shape of the valve actuator nose 150 allow the valve blades to apply force vectors to the nose 150 to cause the valve actuator 122 to move from the distal position shown in FIG. 11 to a proximal position, as shown in FIG. 10. In addition, as discussed above, the ramp structure of the locking device 124 applies a restoring force to the nose, such as a plastic portion located on the nose, to move the valve actuator 122 in a proximal direction to return the valve actuator to substantially the position shown in fig. 10.

Thus, it is understood that objects of the invention include a catheter assembly or needle device including a catheter hub with a catheter tubing extending distally, a needle attached to the needle hub, and a needle extending through the catheter hub and the catheter tubing. The catheter hub contains a body having an outer surface and an inner surface defining an internal cavity. A valve and a valve actuator may be located in the internal cavity. In one example, a locking device with an orifice defining body is positioned proximal to the valve and locks the valve into the catheter hub. The locking device may provide contact interaction to open the valve when the valve actuator is advanced distally by the Luer taper to open the valve leaflets, and wherein the contact interaction provides force vectors including a vector that is generally parallel to the longitudinal axis of the catheter hub to return the valve actuator from the distal position to the proximal position as the Luer cone is removed from the catheter hub. The locking device may further provide the function of securing the valve within the catheter hub and preventing the valve from inadvertent proximal displacement causing it to pop out of the catheter hub and fail to provide a restoring force to the valve actuator.

Because the valve actuator can move to a distal position into the valve, such as when pushed by a luer cone to open two or more valve leaflets, and can return to a proximal position when the luer cone is removed to allow the valve leaflets to relax or close to close slots, the valve may go through several activation cycles. In one example, the valve may undergo two or more actuation cycles. For example, the valve may undergo at least three cycles, at least four cycles, at least five cycles, or more. Each actuation cycle may include movement of the valve actuator into the valve to deflect the valve flaps and movement away from the valve.

In fig. 12, fig. 13 and fig. 14 shows cross-sectional side views, front views, and isometric views of three different retention devices 124, which may be retention rings. These retaining rings 124 can be used with the catheter assemblies described herein. In fig. 13 also shows valve 120 with a retaining ring 124. Referring first to the retaining ring or locking device 124 of FIG. 12, the retaining ring has an annular body 220 with a first or distal end 210 and a second or proximal end 212. The annular body 220 has a generally constant outer dimension along the length of the annular body, which is generally cylindrical. Internally, the annular body 220 has a smaller inner diameter at the distal end than an inner diameter at the proximal end, and a wall thickness that decreases in size from the distal end to the proximal end. The inner surface of the annular body 220 defines an opening in which it is configured to receive a valve actuator and compress or displace the valve actuator nose to create a pair of force components, as previously discussed. In another example, the locking device is sized and shaped to be positioned away from the nose when the Luer cone abuts the Luer cannula of the catheter hub. In one example, the fixation device 124 is formed from a medical grade plastic material. In other examples, the fixation device may be formed from a medical grade elastomeric material or a thermoplastic elastomeric material. Alternatively, the locking device may be manufactured from a metallic material, for example by stamping and bending or machining.

As shown in FIG. 12, a cross-section of the annular body 220 has the shape of a ramp or inclined surface on the inner surface of the annular body. In addition, the inclined surface has a constant slope. In other examples, the slope of the inclined surface is not constant. For example, there may be one or more irregularities or inflection points to produce a contour that is not straight. The contour, whether it has a constant slope or not, may be selected to create compression, displacement, or contact interaction with the nose of the valve actuator 122, such as the plastic portion or portions of the nose, when the valve actuator is pressed against the detent device 124 Compression, displacement, or contact interaction with the valve actuator 122 is configured to produce force vectors that include a force generally parallel to the longitudinal axis of the valve actuator. This in turn helps the valve actuator move from a distal to a proximal position. The locking device 124 of FIG. 12 is similar to the locking device 124 shown in FIG. 4-7.

In fig. 13 shows valve 120 and locking device 124. Locking device 124 may be similar to the locking device described with reference to FIG. 8 and 9, and valve 120 may be similar to valves described elsewhere herein, for example with reference to FIGS. 3-7. As shown in the different views of FIGS. 13, valve 120 has a valve body 224 with an outer perimeter 226, a proximally facing surface 228, and a distal facing surface 230. The proximally facing surface 228, distal facing surface 230, or both surfaces 228, 230 have a first valve portion 168 and a second valve portion 170, as discussed earlier.

The first and second parts of the valve 168, 170 define areas or sections of different thicknesses. Additionally, these two regions may be shaped to form contours into which slots 234 may be included to form valve flaps 194. As shown, valve 120 has three slots 234 that converge toward a center point and extend outward toward an outer perimeter 226. but not reaching the outer perimeter. In one example, the slots 234 are formed only through the thinner second portion 170 of the valve body 224. In some examples, there may be more or less than three slots defining more or less than three valve flaps.

As discussed previously, the proximally facing surface 228 has an annular slot or annular groove 206 for receiving the distal end 210 of the locking device 214. In some example, the annular slot is an annular channel with a gap that engages neither the inner nor the outer surfaces of the distal end of the locking device. The locking device 124 may be made of a thin-walled cylinder, such as a metallic material or plastic, and the proximal end 212 is curved outward to terminate in a curved edge 214, like a rounded corner. An inner surface of the annular body 220 of the locking device 124 defines an opening, wherein the opening is configured to receive a valve actuator and compress or displace the nose portion 150 of the valve actuator 122, such as the plastic portion or portions of the nose portion, to create a pair of force components, as previously discussed. In particular, the rounded corner of the curved edge 214 is configured to compress or displace the actuator nose and apply a pair of force components. In another example, the locking device is sized and shaped to be spaced from the nose when the Luer cone contacts the Luer cannula of the catheter hub. As shown, the curved edge 214 has an outer diameter, and the outer diameter of the curved edge is smaller than the outer diameter of the valve 120. Depending on the structure of the internal cavity of the catheter hub, the size of the curved edge 214 can be adjusted so that when installed inside the catheter hub, the curved edge abuts or contacted with the collar to fix the retaining ring in the internal cavity of the catheter sleeve.

In fig. 14 shows a locking device 124 which is similar to the locking device described with reference to FIG. 10 and 11. As shown, the annular body 220 has a distal end 210 with a curved edge defining a flange 216 that has a generally flat wall surface for contact with the valve surface. The annular locking device body 220 has a generally constant wall thickness that extends from a first diameter at a distal end located immediately adjacent the flange 216 to a second larger diameter at a proximal end 212 that has a proximal edge 218 for abutment or contact with a collar within the catheter hub. 102 for holding the locking device 214 within the catheter hub. The wall surface has an inclined surface resembling a ramp. An inner surface of the annular body 220 of the locking device 124 defines an opening, wherein the opening is configured to receive a valve actuator and compress or displace a nose portion of the valve actuator, such as a portion or portions of the nose portion including an elastomeric strip, plate, or material, to create a pair of force components, as discussed earlier. In another example, the locking device is sized and shaped to be spaced from the nose when the Luer cone contacts the Luer cannula of the catheter hub.

In fig. 15 shows various views of a conical coil spring 238 having a plurality of interlocking coils 240 that are generally inclined along the same direction. The spring 238 may be made of a metallic material. In fig. 15 shows a conical coil spring 238 in a length configuration 242, a conical coil spring in a ring configuration 244 with two ends connected along the length of the spring, and a side view of one conical coil 240 having an overall elliptical shape. Conical coil springs are well known in the spring art, and the coils of a conical coil spring are understood to flex or compress in a radial direction relative to the centerline of the ring, which is understood to extend in and out of the page at the center of the spring ring 244.

Now with reference to FIG. 16 in addition to FIG. 15 shows a catheter assembly 100 of the present embodiment, which is similar to the catheter assemblies of FIG. 4-11 with some exceptions. In the present embodiment, a spring 238 in the configuration of a spring ring 244 is used as the locking device 124. The conical coil spring 238, as the locking device 124, is adjacent to the proximally facing surface 228 of the valve 120 and may be adjacent to the shoulder 176 in the internal part 123 of the catheter sleeve 102 to secure the spring ring inside the bushing. The proximally facing surface 228 of the valve 120 may have a recess for mating with the distal arc of the conical coil spring. In the proximal position of the valve actuator in FIG. 16, the coils 240 of the conical coil spring 238 contact both the inner surface of the catheter hub 102 and/or valve 120 and the nose portion 150 of the valve 122 actuator. In other examples, the coils may be spaced away from the surface of the nose portion 150, such as not contacting the nose portion. in the proximal position of the valve actuator.

In fig. 17 shows actuator 122 pushed distally by the medical instrument's luer cone 200 to open or deflect the leaflets of valve 120, similar to FIG. 7, 9 and 11. The conical coil spring 238 is shown compressed by the nose 150 of the valve 122 actuator. More specifically, each coil 240 of the plurality of coils of the conical coil spring 238 is compressed by the nose 150 of the valve 122 actuator as the coils of the conical coil spring are compressed when compressed radially direction of the center line of the spring ring. The compression of the coils creates force vectors at the nose portion 150 as the coils tend to relax or return to their original position. The force vectors generated at the nose portion include a force that is generally parallel to the longitudinal axis of valve opening. The distally directed axial force vector is applied to the proximal surface of the valve 120 if the coils are compressed on one side by the valve, or to the interior of the catheter hub 102 if the coils are compressed on one side by the catheter hub, and the proximally directed force vector is applied to the valve actuator 122.

When the cone 200 is removed, the coils 240 of the spring 238 expand and press against the nose 150, creating a pair of force components, including a proximally directed axial force vector. This, in turn, helps push the valve actuator 122 in a proximal direction to return the valve actuator 122 to the proximal position and allow the valve 120 to return to the closed position, as shown in FIG. 16. The forces generated by the snap ring 244 to move the valve actuator 122 after the luer cone 200 is removed are in addition to the forces generated by the valve flaps 120 returning to a relaxed or closed state to close the valve slots after the luer cone is removed. Proximally directed forces may move the valve actuator 122 from a distal position back to a proximal position within the catheter hub 123 after the medical instrument pin is disconnected from the catheter hub 102.

Because the valve actuator can move to a distal position into the valve, such as when pushed by a luer cone to open two or more valve leaflets, and can return to a proximal position when the luer cone is removed to allow the valve leaflets to relax or close to close slots, the valve may go through several actuation cycles. In one example, the valve may undergo two or more actuation cycles. For example, the valve may undergo at least three cycles, at least four cycles, at least five cycles, or more. Each actuation cycle may include movement of the valve actuator into the valve to deflect the valve flaps and movement away from the valve.

In fig. 18 and 19 show another embodiment of a catheter assembly 100 that is similar to the catheter assemblies in FIGS. 4-11 and 16-17 with some exceptions. In the present embodiment, the valve 120 is provided with an integrated or separately formed locking device 124. In the present embodiment, the integrated or separately formed locking device 124 may be a retaining skirt portion 250 having a generally cylindrical length and an open proximal end with a triangular cross-section similar to a triangular cross-section. locking device 124 of FIG. 4-7. The additional outer surface area of the skirt portion 250 or locking device contributes to holding the valve 120 in the catheter hub 102 when the needle is withdrawn and when the valve actuator 122 is pressed by the Luer cone 200 (FIG. 19) to open the valve 120.

The skirt portion 250 is sized such that when the valve actuator 122 is pushed distally by the Luer cone 200, the triangular section of the skirt can be compressed, deformed, or displaced by the conical nose portion 150 and the interior of the catheter hub 102 to store energy. Therefore, when a pin tip 200, such as a Luer cone, syringe, or an IV set tip, is removed, the triangular skirt 250 expands, applying a pair of force components to the nose portion 150 that includes a proximally directed axial force vector. This in turn helps push the valve actuator 122 in a proximal direction to return the valve actuator 122 to the proximal position from the distal position and allow the valve 120 to return to the closed position, as shown in FIG. 18.

Because the valve actuator can move to a distal position into the valve, such as when pushed by a luer cone to open two or more valve leaflets, and can return to a proximal position when the luer cone is removed to allow the valve leaflets to relax or close to close the slots , the valve may go through several actuation cycles. In one example, the valve may undergo two or more actuation cycles. For example, the valve may undergo at least three cycles, at least four cycles, at least five cycles, or more. Each actuation cycle may include movement of the valve actuator into the valve to deflect the valve flaps and movement away from the valve.

In fig. 20 and 21 show another embodiment of a catheter assembly 100 that is similar to the catheter assemblies of FIG. 4-11 and 16-19 with some exceptions. In the present embodiment, the locking device 124 is a retaining ring, and the retaining ring is provided with integral or individually formed flexible flaps or leaf springs 256. Referring to FIG. 22, the locking device 124 is similar to the locking device described with reference to FIG. 10, 11 and 14. As shown in the figure, the locking device has an annular body 220 with a distal end 210 with a curved edge defining a flange 216 that has a generally flat wall surface for abutment against the valve surface. The annular body 220 has a generally constant wall thickness that extends from a first diameter at the distal end, immediately proximal to the flange 216, to a second larger diameter at the proximal end 212, with a proximal edge 218 that may contact or contact a collar within the catheter hub for retention. locking device 214 inside the catheter hub. Alternatively, the collar may be omitted and the proximal edge 218 may be an interference fit into the inner edge of the catheter hub. The wall surface has an inclined surface resembling a ramp. An inner surface of the annular body 220 of the locking device 124 defines an opening, wherein the opening is configured to receive a valve actuator and compress or displace the nose of the valve actuator to create a pair of force components, as previously discussed.

In the present embodiment, two or more leaf springs 256, such as three to eight leaf springs 256, may be provided as part of the retaining ring 124 to hold the valve 120. In another example, only one leaf spring may be included. Leaf springs 256 may be formed by forming a symmetrical three-sided cutout on the annular body 220 and folding the cutout inward to form a leaf spring. However, cutouts can be more than just three-sided, such as a partial circle cutout or a multi-sided cutout with more than three sides. Any number of cutouts can be used to form the leaf springs on the retaining device to create force vectors on the valve actuator, with three-way cutouts being preferred. After the one or more cutouts are formed, the bending direction of the cutouts to form the leaf spring(s) is the direction that allows the one or more leaf springs to contact the nose of the valve actuator.

The leaf springs 256 may be sized such that when the valve actuator 122 is pushed distally by the luer cone 200, as shown in FIG. 21, the leaf springs 256 diverge, deflect outward, or move outward from the centerline of the retaining ring by the conical nose 150 of the valve actuator 122. Consequently, when the pin tip 200 is removed, the leaf springs 256 compress or converge, eg, return to their decompressed state, to apply a pair of force components to the nose portion 150 that includes an axial force vector in the proximal direction. The biasing forces of the leaf springs help push the valve actuator 122 in a proximal direction to return the valve actuator 122 from the distal position to the proximal position and allow the valve 120 to return to the closed position, as shown in FIG. 20. The forces of the leaf springs 256 complement the forces generated by the valve flaps returning to a relaxed or closed position to close the valve slots after the luer cone 200 is removed. In an embodiment with one or more leaf springs, the nose portion may be rigid without any plastic portion or portions that may be included as desired.

Because the valve actuator can move to a distal position into the valve, such as when pushed by a luer cone to open two or more valve leaflets, and can return to a proximal position when the luer cone is removed to allow the valve leaflets to relax or close to close the slots , the valve may go through several actuation cycles. In one example, the valve may undergo two or more actuation cycles. For example, the valve may undergo at least three cycles, at least four cycles, at least five cycles, or more. Each actuation cycle may include movement inward of the valve to deflect the valve flaps and movement away from the valve.

In fig. 23 and 24 show another embodiment of a catheter assembly 100 that is similar to the catheter assemblies of FIGS. 4-11 and 16-21 with some exceptions. For example, the present catheter assembly may have a needle and needle hub that have been removed, but may be the same as those described elsewhere herein. The catheter hub 102 of FIG. 23 may also have a pair of wings 260 extending laterally from the longitudinal axis of the catheter hub 102 in opposite directions at the bottom of the catheter hub. View in Fig. 23 is shown as a sectional top view. A pair of wings 260 may be used by a physician to secure the catheter hub to a patient after successful venipuncture, for example, using adhesive tape or an adhesive bandage. In fig. 24 shows the assembled catheter of FIG. 23 without wings. The needle assembly 100 may also include a needle guard mechanism 130 (FIG. 5), as described herein.

In the present embodiment, the locking device 124 is a retaining ring, and the retaining ring is provided with integral or separately formed flexible leaf or leaf springs 256, similar to the embodiment of FIGS. 20-22. However, as described in more detail below, the locking device 124 is an eyelet in which one or more leaf springs 256 extend from the flange.

With reference to FIG. 25, the locking device 124 has an eyelet configuration and may be used in the catheter embodiment of FIG. 23 and 24. As shown, the locking device 124 has a flange 216 for an annular body 220 that has an outer diameter (OD) and an inner diameter (ID) defining an opening. The flange 216 may have a thickness that may be the thickness of the metal sheet used to form the eye. The flange thickness and the leaf spring thickness may be the same or approximately the same. If the flange and leaf springs are formed from the same metal sheet, the thickness of the flange and the thickness of each of the leaf springs can be the same, within the tolerance of the thickness of the metal sheet.

In the example shown, the cylindrical or elongate hollow body does not protrude from the flange 216. Instead, two or more leaf springs 256, such as three to eight leaf springs 256 or at least one leaf spring, may protrude directly from the flange 216. As shown in the figure. , four leaf springs 256 are included in the flange 216, and each leaf spring is located at approximately 90 degrees with respect to the adjacent leaf spring. Leaf springs can be spaced equally apart along the contour of the flange. The leaf springs 256 may extend proximally from the ID flange and terminate at a proximal end edge 270. The proximal end edge of the leaf spring 256 may be flat or rounded. The leaf springs 256 may be spaced equally or approximately equally spaced along the flange ID. Each leaf spring may have a width and length sufficient to produce a force component at the nose portion 150 of the valve 122 actuator, and collectively all of the leaf springs 256 may produce a proximally directed force that may move the valve 122 actuator from a distal position to a proximal position upon removal of the cone. Luera, as described in more detail below.

In the illustrated embodiment, a pair of internal cutouts or slits 262 are provided on the inside diameter of the flange and on each side edge of each leaf spring 256 to allow each leaf spring to have a bend 266 with a bend radius that is recessed from the inside diameter of the flange. In other examples, the pair of internal cutouts 262 may be omitted and the bend in the proximal direction at each bend 266 may be square or right angled. In an alternative design, the bend radius may extend slightly inward from the internal diameter of the flange when there are no or insufficient internal recesses.

Again with reference to FIG. 23, the locking ring 124 may be configured to lock the valve 120 into the catheter hub interior 123, like other locking rings discussed herein. In the present embodiment, the valve 120 is supported on the distal surface by an internal collar 173 and on the proximal surface by a flange 216 of the retaining ring 124, which may be supported by an internal collar 176 b on the proximal side of the flange 216 (FIG. 5). Thus, in the position shown, valve 120 is secured or supported in the interior of the catheter hub.

In the proximal valve actuator position shown, the drive end 180 of the valve actuator 122 may contact the proximally facing surface of the valve 120 or may be distant from the proximally facing surface of the valve. Regardless of whether or not there is contact between the valve actuator 122 and the valve 120 at the proximal position of the valve actuator, the nose portion 150 is located within the boundary defined by the leaf springs 256 but does not contact the leaf springs 256. For example, at the proximal position of the valve actuator 122 valve nose 150 is spaced from the leaf springs 256 and flange 216. This distance allows the valve actuator 122 to move distally into the valve 120 to open the valve flaps 194 before the nose 150 contacts the leaf springs 256.

In one example, flange 216 includes one or more relief shapes or cutouts 268 on the outer diameter of the flange. The raised cutouts may reduce contact interaction between the outer diameter of the flange and the inner bore of the catheter hub during installation of the locking device 124 into the catheter hub. Each cutout 268 may be formed as a straight line through two points on the arc of the outer diameter of the flange. In some examples, each cutout may be in the form of a curve, a curve, and at least one straight cutout, or a complex curved cutout. In one example, a notch 268 may be provided on each leaf spring 256 on the outer diameter of the flange. In other examples, the cutouts may not be positioned in accordance with the arrangement of the leaf springs 256, for example, not directly on the outer diameter portion at the same location on the inner diameter as the leaf spring. In other examples, there may be more or less cutouts than the number of leaf springs.

In fig. 24 shows a luer cone 200 advanced distally into the interior of the catheter hub to move the valve actuator 122 from the proximal position of FIG. 23 to a distal position to open the flaps 194 of the valve 120 and the slots formed therebetween, for example, during insertion of a Luera drip cone or intravenous set. In the distal position, the nose portion 150 projects through the valve slits to deflect the valve leaflets 194 distally and may compress the valve leaflets between the nose portion and the inner surface of the catheter hub, or the valve leaflets may be deflected or deformed distally by the nose portion of the valve actuator with or without compression. him.

The drive end 180 is shown distal to the distally deviated valve leaflets 194. In other examples, the drive end may be located at approximately the same axial position as the deflected valve leaflets, or proximal to the valve leaflets, while still allowing fluid to flow through the valve 120 in a proximal or distal direction.

The leaf springs 256 may be positioned on the flange 216 such that when the valve actuator 122 is pushed distally by the luer cone 200, as shown in FIG. 24, the leaf springs 256 are deflected radially outward by the conical nose 150 of the valve actuator 122. In one example, the proximal edge 270 of each leaf spring 256 is spaced from the interior of the catheter hub when the nose portion 150 of the valve actuator 122 is deflected. In another example, the proximal edge 270 may contact the inner surface of the catheter hub. The deflected leaf springs 256 and deflected valve flaps 194 provide an energy reserve that can then push against the valve actuator nose 150 to move the valve actuator proximally as the luer taper is removed.

Therefore, when the pin tip 200 is removed, the leaf springs 256 may compress or converge to apply a pair of force components to the nose portion 150 that include an axial force vector in the proximal direction. The displacement forces of the leaf springs help push the valve actuator 122 proximally to return the valve actuator 122 from the distal position to the proximal position and allow the valve 120 to return to the closed position, as shown in FIG. 23. The forces of the leaf springs 256 complement the forces generated by the flaps 194 of the valve 120, which return to a relaxed or closed position to close the valve slots after the luer cone 200 is removed. In an embodiment with one or more leaf springs, the nose portion 150 may be rigid with no plastic portion or portions that may be included as desired.

Because the valve actuator 122 may move to a distal position within the valve 120, such as when pushed by the luer cone 200 to open two or more leaflets of the valve 194, and may return to a proximal position when the luer cone 200 is removed to allow the valve leaflets to relax or close the slots, valve 120 may undergo several actuation cycles. In one example, the valve may undergo two or more actuation cycles. For example, valve 120 may undergo at least three cycles, at least four cycles, at least five cycles, or more. Each actuation cycle may include movement into the valve by the valve actuator to deflect the valve flaps and movement away from the valve.

Now with reference to FIG. 26 illustrates a locking device, ring, or member 124 in accordance with further aspects of the invention. The present locking device 124 may be an eyelet similar to the locking device 124 of FIG. 25 and can be used with a catheter assembly in a manner similar to the locking device of FIG. 25. Thus, the present eye has a flange 216, at least one leaf spring 256 with four shown, and one or more projections 268 on the outer diameter of the flange with four shown.

In the present embodiment, the lug flange 216 may have an arc or camber shape in cross-section. In other words, the distal facing surface and the proximal facing surface of the flange 216 have an arcuate or curved shape. In one example, the distal facing surface of the flange 216 is convex in shape and the proximally facing surface of the flange 216 is concave in shape. The curved flange 216 may facilitate installation because the insertion direction of the locking device 124 and the arcuate cross-sectional shape of the flange 216 allow the outer diameter of the flange to fit smoothly against the inner surface during installation. The curved section also strengthens the flange against deformation during installation.

The relief shapes or cutouts 268 on the outer diameter of the flange of the present lug are not aligned with the leaf springs 256. Using the clock hand, the leaf springs 256 can be located at the 2, 4, 8 and 10 o'clock positions along the inner diameter of the flange, and the cutouts 268 can be located at positions 3, 6, 9 and 12 o'clock along the outer diameter of the flange. In other examples, the arrangement of the leaf springs 256 along the inner diameter of the flange and the arrangement of the cutouts 268 along the outer diameter of the flange may vary. In addition, the number of leaf springs and notches can be different, for example, two leaf springs and three notches or three leaf springs and two notches.

As shown, due to their curved or arcuate cross-section, the leaf springs 256 of FIG. 26 can be folded without the need to include cutouts or slits 262, as shown in the embodiment of the invention in FIG. 25. However, slots or cutouts may be provided to allow the projections to be bent to form leaf springs.

Now according to FIG. 27 and 28, a catheter assembly or needle assembly 100 in accordance with other aspects of the invention is shown (a) with the needle and needle hub removed, but may have the same needle and needle hub as described elsewhere herein. The needle assembly 100 may also include a needle guard mechanism 130, as described elsewhere herein.

In the present embodiment, the catheter hub 102, catheter tube 104, valve 120, valve actuator 122, and locking device 124 may be similar to those shown with reference to FIG. 18-19, with some exceptions. In the exemplary embodiment, the retaining device 124 is a retaining ring made of an elastomeric material. For example, the locking device 124 may be made of an elastomeric material, such as an O-ring, to provide a proximally directed force on the valve actuator when compressed or deformed between the valve actuator nose 150 and the inner wall of the catheter hub 102 in the distal valve actuator position. The locking device 124 may have an O-ring structure of various possible cross-sections, such as round, oval, square, rectangular. As shown, the locking device 124 is an elastomeric O-ring. The locking device 124 may be formed separately from the valve 120 and used in conjunction with the valve 120 to secure the valve to the interior of the catheter hub.

As shown, valve 120 is secured or supported distally by an internal collar 173 that prevents or limits axial distal movement of the valve's outer perimeter while still allowing valve flaps 194 to deflect distally when pressed by valve actuator 122. The valve 120 is secured or held on the proximal side by a locking ring 124, or an elastomeric ring in the present embodiment. The elastomeric ring may abut the inner collar 176 b to secure the elastomeric ring, and therefore the valve, from proximal movement.

The locking device 124 and the nose portion 150 of the valve actuator 122 are spaced apart at the proximal position of the valve actuator in FIG. 27. The gap or distance therebetween provides play to allow the valve actuator 122 to move distally to open the valve, such as to deflect the valve leaflets 194, until the gap is eliminated, the valve actuator contacts or impacts the locking device 124. In the condition shown in FIG. 27, the drive end 180 on the nose 150 of the valve actuator 122 is located within the hole defined by the locking device 124, but at a distance, that is, without contact with the locking device 124. The conical surface of the nose is also spaced from the locking device. This distance or clearance allows the valve actuator 122 to move forward in a distal direction before it impinges or contacts the locking device 124. The valve actuator driving end 180 is shown in contact with the proximally facing surface of the valve 120. In other examples, the valve driving end 180 may be slightly removed from the proximally facing surface of the valve.

In fig. 28 is a cross-sectional side view of the assembly of FIG. 27 with a luer cone 200 inserted into the open proximal end 136 and advancing the valve actuator 122 into the valve 120 to open the valve leaflets 194 and fluid communication between the luer cone 200 and the lumen of the catheter tube 104 similar to other embodiments described herein. Although not shown, the luer cone 200 may have a threaded ring to engage the lugs or external threads 202 on the catheter hub to hold the valve actuator in a distal position to open the valve.

In one example, the valve actuator 122 is configured to move distally as the luer cone 200 advances. The distance that the valve actuator moves distally must be sufficient to cause the actuator end 180 and nose portion 150 to deflect the valve flaps 194 distally to open the slots and thereby open fluid communication between the luer cone 200 and the tube. 104 catheters. In the example shown, the drive end 180 of the valve actuator 122 is moved distal to the valve leaflets, and the valve leaflets are compressed between the interior of the catheter hub 102 and the conical surface of the nose portion 150, or the valve leaflets are deflected or deformed distally by the nose of the valve actuator, with or without compression. In some examples, the drive end 180 moves a distance equal to or shorter than the ends of the valve flaps, but the valve opens sufficiently to allow free flow in both directions.

In the example shown, the elastomeric ring of the locking device 124 acts as a biasing element. For example, when the nosepiece 150 is pressed against the locking device 124 and compresses or displaces the locking device between the nosepiece and the inner surface of the catheter hub, the stored energy is transferred to the elastomeric material, which allows the elastomeric material to exert an opposing biasing force on the nosepiece 150 of the drive. Thus, when the nose piece 150 is pressed against the elastomeric ring, the elastomeric ring creates a pair of force components or force vectors on the nose piece 150 that includes a force acting generally parallel to the longitudinal axis of the catheter hub in the proximal direction.

When the Luer cone 200 is removed, for example, when replacing an intravenous fluid bag attached to the Luer cone 200, the action of a distally directed force on the proximal edges 182 of the two plunger elements 152 on the side of the Luer cone 200 is removed or stopped, and the Luer cannula 204 is not occupied. no external object. This allows the valve actuator 122 to return to its proximal position in FIG. 27, now vacated by the Luer cone. In one example, the elasticity of the valve 120 allows the valve flaps 194 to return to a more relaxed state, such as moving to the position shown in FIG. 27. This returning action of the valve blades 194 and the shape of the valve actuator nose 150 allow the valve blades to apply force vectors to the nose 150, causing the valve actuator 122 to move from the distal position shown in FIG. 11 to a proximal position, as shown in FIG. 10. Additionally, as discussed above, the elasticity of the locking device 124 exerts a restoring effect on the nose portion 150 to move the valve actuator 122 proximally to return the valve actuator substantially to the position shown in FIG. 27.

Thus, it is understood that the subject matter of the invention is understood to include a catheter assembly or needle device including a catheter hub with a catheter tubing extending distally, a needle attached to the needle hub and extending through the catheter hub and the catheter tubing. The catheter hub consists of a body having an outer surface and an inner surface defining the internal cavity. A valve and a valve actuator may be located in the internal cavity. In one example, a locking device with an orifice defining body is positioned proximal to the valve and locks the valve into the catheter hub. The locking device may provide contact interaction with the valve actuator as the valve actuator is advanced distally by the Luer cone to open the valve leaflets, and wherein the contact interaction provides force vectors including a vector that is directed generally parallel to the longitudinal axis of the catheter hub to return the valve actuator from distal position to the proximal position when the Luer cone is removed from the catheter hub. The locking device may further provide the function of securing the valve within the catheter hub and preventing the valve from inadvertent proximal displacement causing it to pop out of the catheter hub and fail to provide a restoring force to the valve actuator. The locking device may be an elastomeric material. In a preferred embodiment, the material has a hardness of 30 to 70 Shore A. It may also have a Shore A hardness of less than 30 or greater than 70. In one example, the elastomeric material is an O-ring. In a specific example, the sealing ring may have a circular cross-section.

Because the valve actuator can move to a distal position into the valve, such as when pushed by a luer cone to open two or more valve leaflets, and can return to a proximal position when the luer cone is removed to allow the valve leaflets to relax or close to close the slots , the valve may go through several actuation cycles. In one example, the valve may undergo two or more actuation cycles. For example, the valve may undergo at least three cycles, at least four cycles, at least five cycles, or more. Each actuation cycle may include movement of the valve actuator inward of the valve to deflect the valve leaflets and movement away from the valve to close the leaflets.

Now, based on FIG. 29 and 30, a catheter assembly or needle assembly 100 in accordance with other aspects of the invention is shown with the needle and needle hub removed, but may have the same needle and needle hub as described elsewhere herein. The needle assembly 100 may also include a needle guard mechanism 130, as described elsewhere herein. The catheter assembly in question is particularly similar to the catheter assembly of FIG. 27 and 28 discussed immediately above. For example, the subject locking device 124 may be made of an elastomeric material, similar to the embodiments of FIGS. 27 and 28. However, in the present embodiment, the elastomeric material, which may be an O-ring, may have a generally square or polygonal cross-section.

Now with reference to FIG. 31, 32A and 32B, another embodiment of a catheter assembly or needle assembly 100 is shown which is similar to the catheter assembly of FIG. 4-11 and 16-21 with some exceptions. In fig. Figure 31 shows the catheter assembly with the needle and needle hub removed, but may have the same needle and needle hub as described elsewhere in this document. The needle assembly 100 may also include a needle guard mechanism 130, as described herein. In fig. 32A shows a luer cone 200 inserted into a luer cannula 204 (FIG. 31) and advancing a valve actuator 122 to open the valve 120, as described in more detail below. In fig. 32B is a view similar to FIG. 32 A, but rotated 90 degrees along the longitudinal axis of the catheter hub. In the exemplary embodiment, valve 120 is provided with an integral or separately formed locking device 124. In the present embodiment, the integral or separately formed locking device 124 may be a retaining skirt section 250 formed with valve disc 121 (FIGS. 34 and 35). The skirt portion 250 may have a generally constant thickness and a proximal end surface 290 that is sized to abut or contact the inner collar 176 b of the catheter hub to secure the valve 120 within the catheter hub 102 from proximal movement. The proximal end surface 290 of the skirt portion 250 is of sufficient thickness such that a portion of the skirt portion is exposed radially from the inner flange 176 b. This open portion of the skirt portion allows or provides a target for the valve actuator 122 to press to compress, deform, or displace the skirt portion 250, as described in more detail below.

Based on FIG. 34 in addition to FIG. 31, the valve 120 of the present embodiment may have a valve disk 121 and an integral skirt 250. In the example shown, the valve disk 121 and the skirt portion 250 are formed separately. The skirt portion 250 can be viewed as a generally cylindrical length having an open proximal end. The valve disc 121 is shown with a plurality of valve disc slots or slot sections 234 defining a plurality of valve flaps 194. In the exemplary embodiment, the wall thickness of the valve disc 121 in the axial direction is generally constant, without separate first sections 168 and second sections 170, as shown in FIG. .13 and elsewhere in this description. However, separate first portions 168 and second portions 170 may be included within a valve having a valve disc 121 and a skirt portion 250, as shown in FIG. 35.

In one embodiment, rather than including a generally constant thickness along the entire length of the skirt portion 250, the skirt portion may include a ramp-shaped surface in cross-section, similar to that shown in FIG. 18 and 19. For example, a valve 120 with a disk 121 having separate first and second portions 168, 170, as shown in FIG. 35 may have a skirt section 250 with a ramp-shaped section. It is intended that valve 120 of FIG. 35 can be used with the catheter assembly according to FIG. 31, 32 A and 32 B, similar to valve 120 of FIG. 34.

In the present embodiment, the valve actuator 122 has a body consisting of a nose portion 150 and a proximal portion 157 including two plunger elements 152, two protrusions 154, and two stabilizing elements 158, like other valve actuators described herein. The plunger elements 152 may be spaced apart from each other and have at least one flow path located between them. Each plunger element may include ribs, bumps, projections, or sections of varying thickness to control the stiffness of the plunger element. The ridges or bumps may also assist in agitating the flushing flow as fluid passes between the plunger elements. The valve actuator 122 of the present embodiment is shown in perspective in FIG. 33 and in cross section according to FIG. 31, 32 A, and 32 B. In some examples, valve actuator 122 of FIG. 33 can be formed individually. In other examples, the valve actuator may be molded or cast from one or more different materials or components. For example, the two stabilizer elements 158 may be made of a metallic material that may be molded along with the remaining parts of the valve actuator 122.

In some examples, the distal and proximal edges of the stabilizing elements 158 may be parallel to each other. The distal edge of the stabilizing element 158 may be generally orthogonal to the longitudinal axis of the valve actuator 122 or angled to the longitudinal axis. Each of the two stabilizing elements 158, if there are two, may have a length and a constant width along the length. However, the width may vary along the length of the stabilizing element 158, as shown in FIG. 43. In other examples, one or both of the stabilizing elements may not be continuous, such as having a gap.

In the present embodiment, a transition portion 296 is provided proximal to the nose portion 150. As shown in FIG. 33, the transition portion 296 includes a pair of drive beads 294, each of which has a mating edge 298. The two drive beads 294 may be spaced apart from each other. each other, and the two mating edges 298 may be located at approximately the same axial point or location on the valve actuator on opposite sides of the nose 150 to press into the valve 120 at approximately the same time as the valve actuator is advanced by the luer cone 200. Each bead 294 may include an inclined or beveled surface extending proximally from the mating edge 298. Two actuator beads 294 are located adjacent the seat 300 on the valve actuator transition portion 296. To improve stability and/or strength, the valve actuator body may be provided with raised edges or ribs.

In some examples, two drive beads 294 with angled surfaces and touching edges 298 may be omitted or modified from the shapes shown. For example, the nose portion 150 may extend directly to the stepped bead 293 in the transition portion 296 without the ramped beads 294. Without the ramped beads 294, the mating surfaces 295 on the stepped beads 293 may compress the skirt portion. In other examples, the angled beads 294 may have different shapes, such as being generally square or having square surfaces without a tapered surface, such that the adjacent edges 298 are at approximately the same height as the beads 294 themselves. In other words, on two sides of the nose The valve actuator portion 150 may be provided with tapered edges 298 without tapered shoulders 294. When using an alternative valve actuator 122 without tapered shoulders 294, the mating edges 295 of the two stepped shoulders 293 can be directly pressed against the proximal end surface 290 of the valve 120.

As shown in FIG. 33, the outer diameter (OD) at the seat 300 is generally constant. In one example, the length of the landing portion 300 has a uniform outer diameter along its entire length. In other examples there may be a slight increasing slope or a small decreasing slope. An inclined surface on the landing portion 300 may be used as long as the landing portion does not abut or contact the skirt portion 250, as shown in FIG. 32 A and 32 V, and/or does not weaken the transition section, rendering it ineffective as a valve actuator. As shown, the opening in the nose portion 150 and the landing portion 250 has a generally constant internal diameter (ID).

Distal to the landing portion 300, on the outer side, the nose portion 150 can be described as a generally frustoconical shaped structure. The conical surface of the nose portion 150 allows the valve flaps 194 to apply a pair of force components, which include a proximally directed force, to return the valve actuator 122 to its proximal position after removal of the Luer cone.

In fig. 32A shows the two mating edges 298 of the two actuator beads 294 (FIG. 33) that are pressed against the proximal surface 290 of the skirt portion 250 of the valve 120 due to the luer cone 200 pushing the valve actuator 122 distally into the valve. The overlapping surfaces of the skirt portion 250 and the actuator beads 294 indicate contact interaction or compression of the skirt portion 250 between the distal bead 173 and the mating edges 298 of the valve actuator. Thus, when valve 120 is opened by valve actuator 122, valve flaps 194 are compressed between valve actuator nose 150 and the inner surface of the catheter hub, or deflected or deformed distally by the valve actuator nose, and skirt portion 250 is compressed or deformed between distal collar 173 and two mating edges 298 of the valve actuator. In cases where the mating edges 298 and beads 294 with conical surfaces are lowered, the end surfaces 295 of the two stepped beads 293 (FIG. 33) can compress the skirt portion 250. The size and shape of the stepped bead 293 and the nose portion 150 can be adjusted to compress the skirt. part 250 when the tapered shoulders 294 are lowered.

Compression, deflection, deformation, or displacement of various surfaces or portions of valve 120 when activated by valve actuator 122 creates stored energy in the valve. When the Luer cone 200 is withdrawn from the Luer cannula 204 of the catheter hub 102, the stored energy is released as the valve leaflets 194 and skirt portion 250 return to a more relaxed state. Therefore, the valve flaps 194 apply a proximal force to the nose portion 150 and the skirt portion 250 applies a proximal force to the two mating edges 298 to move the valve actuator 122 from the distal position shown in FIG. 32 A and 32 B to the proximal position shown in FIG. 31.

Because the valve actuator 122 may move to a distal position within the valve 120, such as when pushed by the luer cone 200 to open two or more leaflets of the valve 194, and the valve actuator may return to a proximal position when the luer cone is removed to allow the valve leaflets 194 and the skirt portion 250 relax or close the slots 234 (FIGS. 34 and 35), the valve may undergo several actuation cycles. In one example, valve 120 may undergo two or more actuation cycles. For example, the valve may undergo at least three cycles, at least four cycles, at least five cycles, or more. Each actuation cycle may include movement of the valve actuator into the valve to deflect the valve flaps and movement away from the valve.

A valve, such as valve flaps or a valve skirt, may be deflected, displaced, or deformed by a first structure, such as a valve actuator, moving within the valve without the need for the second structure to be located distal to the first structure, although the second structure may be incorporated if desired. For example, the valve leaflets may be deflected distally by the action of the valve actuator as the valve actuator moves in a distal direction. Distal deviation of the valve leaflets can occur with or without the presence of a shoulder or rigid surface located on the distal side of the valve leaflets. However, if there is a shoulder or rigid surface on the distal side of the valve leaflets, the valve leaflets can both deflect distally and be compressed between the valve actuator and the shoulder or rigid structure on the distal side. Other objects may be deflected, displaced, or deformed without an opposing structure, such as a leaf spring deflected, displaced, or deformed by the nose of a valve actuator, or a C-ring or coil of a spring expanded by insertion of a conical portion of the nose.

Thus, it is understood that objects of the invention include a catheter assembly or needle device including a catheter hub with a catheter tube extending in a distal direction, the catheter hub including a body having an outer surface and an inner surface defining an internal cavity. A valve and a valve actuator may be located within the internal cavity. In one example, a locking device with an opening defining body is located proximally from the valve. In one example, the locking device may be integral with the valve and may be a skirt portion. For example, the valve disc may be integral with a valve skirt or skirt portion, wherein the valve skirt may act as a locking device to retain the valve disc within the catheter hub.

The valve leaflets can produce a proximally directed restoring force to return the valve actuator from a distal to a proximal position. In addition, the valve actuator may include one or more mating edges to compress, deform or displace the skirt portion in an axial direction relative to the distal shoulder of the catheter hub. In other words, the valve skirt or skirt portion may have a length, and the valve actuator may compress or deform the valve skirt while driving the valve actuator to a distal position to open the valve and reduce the length of the valve skirt from a first length to a shorter second length. When the skirt section is reduced in length by the valve actuator, the skirt section receives stored energy. Therefore, the skirt portion can apply an axially directed force to the valve actuator when the stored energy is released, for example, onto one or more mating edges of the valve actuator to return the valve actuator to the proximal position after the luer cone is withdrawn.

In one example, the locking device may engage a valve actuator, such as an elastomeric portion of the valve actuator, when the valve actuator is advanced distally by a luer cone to open valve leaflets, such as to deflect the valve leaflets distally with a nose portion, and thereby deflect may provide force vectors including a force vector that is directed generally parallel to the longitudinal axis of the catheter hub to return the valve actuator from a distal position to a proximal position when the Luer cone is removed from the catheter hub. In one example, contact interaction, displacement, deflection, or compression provides energy storage to the valve skirt. The stored energy may be released to force one or more adjacent valve actuator surfaces in a proximal axial direction.

Therefore, the valve actuator may have multiple surfaces, such as a nose and one or more mating edges to deform the valve at multiple distinct locations on the valve to transfer stored energy to the valve. The deformable valve surfaces may include valve flaps and other valve surfaces other than valve flaps. For example, in addition to the valve flaps, the skirt portion may be compressed axially when the valve opens. The catheter hub may include a needle extending through the catheter hub, a valve, a valve actuator, a locking device, and a catheter tubing. The needle may be attached to a needle hub at the proximal end of the needle.

In fig. 36 and 37 show another catheter assembly or needle assembly 100 in accordance with embodiments of the invention. Catheter assembly 100 is shown with the needle and needle hub removed, but may have the same needle and needle hub as described elsewhere herein. The needle assembly 100 may also include a needle safety mechanism, as described herein.

In the present embodiment, the catheter hub 102, catheter tube 104, valve 120, valve actuator 122, and locking device 124 may be similar to those shown in FIG. 8 and 9, with some exceptions. In the present embodiment, an annular slot or annular channel 206 is provided on the proximally facing surface of the valve 120 and is enlarged to receive the distal end of the locking device 124. That is, the enlarged slot of the annular channel 206 of the present embodiment can contact the outer surface of the annular body of the locking device 124, but not with the inner surface of the annular body due to the enlarged gap. The ring body may also contact an end or distal surface of the annular channel to control or set the depth of the annular channel 206 relative to the ring body. This configuration allows the locking device 124 to retain the valve 120 within the catheter hub, as described with reference to FIG. 8 and 9, this reduces the tolerances or simplifies the manufacturing requirements for forming or creating the annular channel 206, since the inner surface of the annular body does not have to be captured by the annular channel. The channel is also easier to form using standard molding methods than to partially cut the valve disc.

In fig. 38a shows a retaining ring 124 used in connection with the catheter assembly 100 of FIG. 36 and 37. As shown, the annular body 220 of the retaining ring 124 of the present embodiment may have a wall length from a proximal end 212 to a distal end 210 with a generally constant wall thickness and a curved portion of the body 214 at the proximal end of the retaining ring. The wall has an interior portion defining an opening for receiving the nose portion 150 of the valve actuator 122. The wall of the locking device 124 may be generally cylindrical, except for a curved portion of the body 214 at the proximal end 212. In one example, the proximal end 212 of the retaining ring 124 may have an outwardly curved projection 214 for securing the retaining ring 124 to an additional inner collar 176 b of the sleeve 102 catheter. Once positioned against the inner collar 176 b, the locking device 124 may help secure the valve 120 from proximal movement. The valve 120 is fixed or supported from distal movement by being positioned against the collar 173 of the catheter hub 102 with the distal facing surface of the valve. In some examples, the curved edge 214 of the retaining ring 124 is press-fitted into the inner surface of the collarless catheter hub.

The subject detent device 124 may be provided with one or more leaf springs 256. As shown, four leaf springs 256 are provided in the detent device and are equally spaced from each other at approximately the 2, 6, 8 and 10 o'clock positions. However, the leaf springs may be positioned at various positions along the arc of the annular body 220. In one example, the leaf spring 256 may be formed by making at least two cuts through the proximal edge 312 of the annular body 220. As shown, the leaf spring 256 is formed from two generally parallel cuts through the curved edge 214 to allow the metal to be bent to form the leaf spring 256 and cuts defining the two side edges of each leaf spring 256.

In one example, all of the leaf springs 256 included in the present locking device 124 can be formed in the same manner, for example, by using two generally parallel cuts for each leaf spring. In other examples, the cuts may be non-parallel. In still other examples, a combination of different leaf springs may be used. For example, the annular body 220 may have two proximally located leaf springs 256 with slits formed through the proximal edge 312, as shown in FIG. 38a, and two leaf springs formed between the distal end 210 and the proximal end 212, similar to the leaf springs of FIG. . 22. In other examples, less than four leaf springs may be used, such as three, two or one, or more than four leaf springs, such as five, six or seven leaf springs. Additionally, the spacing of the cuts can be varied to change the width or size of the leaf springs, which can change the spring force or the displacement force generated by the leaf springs. The slots in the proximal edge 312 to form the leaf springs 256 have the advantage of creating proximal portions 255 between two adjacent leaf springs 256. The proximal portions 255 may deflect or bend when the locking device 124 is inserted into the catheter hub to secure the valve. The ability of the proximal portions 255 to deflect or flex may reduce the insertion force for installation of the locking device. As in the embodiment described above and shown in FIG. 25, there may be a cutout instead of a slot between the leaf spring 256 and the proximal edge 312 of the annular body 220. This will increase the flexibility of both the leaf spring 256 and the proximal edge 312.

In fig. 38 b is an end view of the locking device 124 of FIG. 38 a. In the illustrated drawing, four leaf springs 256 are equally spaced along the proximal end 212 of the locking device. In addition, the locking device is oriented in such a way that four leaf springs are located at the 3, 6, 9 and 12 o'clock positions.

As shown in FIG. 36, the locking device 124 and the nose portion 150 of the valve actuator 122 are spaced apart at the proximal position of the valve actuator. The clearance or distance therebetween provides play for the valve actuator 122 to move distally to open the valve, for example to deflect the valve flaps 194, before contacting or colliding with the locking device 124. In the illustrated condition, the drive end 180 of the valve actuator 122 portion 150 is located internally hole defined by the locking device 124, but at a distance from or without contact with the locking device 124. The drive end 180 and the nose 150 are also spaced from the cylinder by a plurality of leaf springs 256. This distance or clearance allows the drive valve element to move forward in a distal direction before impinging on or contacting a retaining device, such as the leaf springs. The driving end 180 is shown in contact with the proximally facing surface of the valve 120. In other examples, the driving end 180 may be slightly removed from the proximally facing surface of the valve 120.

In fig. 37 is a cross-sectional side view of the assembly of FIG. 36 with a Luer cone 200 inserted into the open proximal end 136 and advancing a valve actuator 122 into the interior of the valve 120 to open the valve leaflets 194 and fluid communication between the Luer cone 200 and the lumen of the catheter tubing 104, similar to the embodiment of FIG. 20 and 21. Although not shown, the luer cone 200 may have a threaded ring to engage the lugs or external threads 202 on the hub of the catheter 102 to further hold the valve actuator 122 in a distal position to open the valve 120.

In one example, the valve actuator 122 is configured to move distally as the luer cone 200 advances. The distance that the valve actuator moves distally must be sufficient to cause the actuator end 180 and nose portion 150 to deflect the valve flaps 194 distally to open the slots and thereby fluid communication between the luer cone 200 and the tube 104 catheter. In the example shown, the drive end 180 of the valve actuator 122 moves distal to the valve leaflets, and the valve leaflets may be compressed between the interior of the catheter hub 102 and the conical surface of the nose portion 150, or may be deflected or deformed distally by the nose portion 150 of the valve actuator 122 without being compressed. As shown, the drive end 180 moves a distance to or less than the ends of the valve flaps 194, but still opens the valve sufficiently to allow free flow in both directions.

In the example shown, the conical surface of the nose portion 150 deflects or displaces a plurality of leaf springs 256 of the retaining ring 124 radially outward to provide energy storage for the leaf springs. The curved edge 214 may act as a biasing element. Thus, when the leaf springs 256 are released, the leaf springs create a pair of force components or force vectors on the nose portion 150 of the valve actuator 122 that include a force acting generally parallel to the longitudinal axis of the catheter hub 102 in the proximal direction.

When the Luer cone 200 is removed, for example, when replacing an intravenous fluid bag attached to the Luer cone 200, the distally directed force acting on the proximal edges 182 of the two plunger elements 152 on the side of the Luer cone 200 is removed or terminated, and the cannula 204 The luera turns out to be unoccupied by an external object. In one example, the elasticity of valve 120 allows valve flaps 194 to open, releasing stored energy, into a more relaxed state, such as the position shown in FIG. 36. This spreading action of the valve flaps 194 and the shape of the valve actuator nose 150 allow the valve flaps 194 to apply force vectors to the nose 150, causing the valve actuator 122 to move from the distal position shown in FIG. 37 to a proximal position, as shown in FIG. 36. In addition, the leaf spring 256 acting on the nose portion 150 also applies a proximally directed force to assist in returning the valve actuator to the proximal position.

Because the valve actuator 122 may move to a distal position within the valve 120, such as when pushed by a luer cone to open two or more valve leaflets 194, and the valve actuator may return to a proximal position when the luer cone is removed, causing the valve leaflets 194 to relax or close to close the slots, the valve may go through several actuation cycles. In one example, the valve may undergo two or more actuation cycles. For example, the valve may undergo at least three cycles, at least four cycles, at least five cycles, or more. Each actuation cycle may include movement of the valve actuator into the valve to deflect the valve flaps and movement away from the valve to close the valve flaps.

Examples of methods for making and using catheter assemblies and components thereof in accordance with embodiments of the invention will now be described, taking into account other process steps. The locking devices 124 disclosed herein may be molded from a suitable thermoplastic or formed from sheet metal, such as stainless steel. The valve 120 itself may be formed from an elastic polymer, silicone, synthetic or natural rubber. Thus, when the retention device 124 is integral with the retention skirt 250 (FIGS. 18 and 19) with the valve 120, the retention skirt 250 may also be made of an elastic polymer, silicone, synthetic or natural rubber. When forming the locking device 124 from a metallic material, the metal has the advantage that it is not susceptible to elastic creep during the shelf life of the device, which can be up to 5 years.

The procedure for assembling a catheter in accordance with embodiments of the invention may include, but is not limited to, the following steps: attaching the catheter tubing to a metal hub, securing the metal catheter tubing to the catheter hub, assembling the valve and locking device in a groove between the distal and proximal collar on the inner surface of the catheter hub. The locking device may abut or press against a collar on the proximal side or end of the locking device. The locking device may be any of the locking devices described herein, including a skirt formed from individual parts, an O-ring, or a snap ring.

Then insert the valve actuator into the catheter hub, insert the end of the needle through the needle guard, attach the thick end of the needle to the needle hub, and open the valve by pressing the proximal end of the valve actuator with the opening tool. In one example, the opening tool may resemble a luer cone, but with a horizontal dividing line to allow the tool to be placed around the needle shaft or to remove the tool from the needle shaft. Then inserting the needle tip first through the open valve, releasing the pressure on the valve actuator, removing the opening tool from the catheter hub, by moving the two halves of the opening tool apart from each other, passing the needle completely through the catheter tube until the needle tip is completely out of the catheter tube, protective the needle mechanism will be in the ready-to-use position and the most distal end of the needle hub will protrude into the catheter hub, attaching the vent plug to the proximal end of the needle hub. Other options for the actions described above are also possible, for example, changing the sequence of steps or eliminating one or more steps. If an additional housing is used as part of the guard mechanism, it may not be necessary to insert the needle guard mechanism into the catheter hub, or only a small portion of the needle guard mechanism may be inserted into the catheter hub.

During application, the tip of the needle penetrates the patient's skin and vein, blood flows through the needle into the needle hub, the tip of the catheter slides over the tip of the needle into the vein, there is a secondary flash of blood rising up the catheter tube, the rest of the catheter tube is inserted into the vein as the needle is removed until the catheter hub is near the insertion site on the skin. Either when the needle is removed from the catheter hub or when the activation step is performed, the needle safety mechanism is activated to protect the user from unintentional needlestick injury. The valve leaflets close as the needle tip moves proximally away from the valve. In this way, the user is protected both from accidental needle sticks and from the leakage of contaminated blood from the catheter hub. The valve continues to protect the user from blood contamination when any pin instruments attached to the Luer cannula of the catheter hub are subsequently removed.

The Luer cannula of the catheter hub can be attached to either a blood collection instrument, an extension line, or a blood injection kit, all with a Luer taper. When the Luer cone is inserted into the catheter hub, the tip presses against the valve, opening the valve for infusion or withdrawal of blood. When the Luer cone is released, the valve closes as described above and the user remains protected from blood leakage from the catheter hub. The valve actuator can be moved from a distal position to a proximal position under the influence of proximally directed forces from the closure of the valve leaflets and from the locking ring described herein. Connections and disconnections can be repeated and still no blood will flow out of the catheter hub. Typically, after blood is drawn from the patient, a syringe filled with flushing fluid is attached to the catheter hub to flush out any remaining blood from the catheter hub and catheter tubing. The catheter hub, valve, locking device or locking ring, and valve actuator should be capable of minimizing residual blood after flushing. Adding holes between the two plunger elements 152 helps minimize blood debris by adding flow paths.

In fig. 39 is a schematic cross-sectional side view of a catheter assembly 100 in accordance with additional embodiments of the invention. The subject catheter assembly 100 is similar to other catheter assemblies described herein, with some exceptions. As in other embodiments of the invention, the catheter assembly 100 may have a needle 108 and a needle hub 106, a catheter tube 104 connected to a catheter hub 102 having a valve 120, and a valve actuator 122 located in the interior portion 123 of the hub body 126. A locking device may also be provided to secure the valve 120 within the catheter hub, similar to the embodiments of FIGS. 4, 5, 8, 9, 20, 21 and 36-38, as well as in other places.

Optionally, valve 120 may be provided with an integral or separately formed locking device. The integral or separately formed retaining device may be a retaining skirt portion with a triangular cross-section or another shaped skirt portion similar to that shown in FIG. 18, 19, 31, 32 A and 32 B. In addition, to protect the needle tip when retracting the needle after successful venipuncture, a needle guard mechanism similar to the needle guard mechanism 130 shown in FIG. 4 and 5 and in other places. In other examples, the needle safety mechanism, as shown in FIG. 45 A-46 B, can be used with the catheter assembly of FIG. 39.

In the present embodiment, the body 126 of the catheter hub 102 has a side port 360 directed in a proximal direction and having an elongated body 362 formed at an acute angle to the longitudinal axis of the hub body 126. The side port 360 may be formed integrally with the catheter hub body 126. The 360 side port can be used with a tube which is then connected at the opposite end to a fluid connector. In a tubeless application, a vent plug, such as a vent plug 112 attached to the needle hub 106, may be installed at the location of the side port 360 opening.

The side port 360 may have a channel 364 with an inlet port. The channel 364 of the side port 360 may be in fluid communication with the internal cavity 123 of the catheter hub and with the lumen of the catheter tube 104. In one example, the side port channel 364 is in fluid communication with the inner chamber or inner cavity 123 distal to the valve 120 and the lumen of the catheter. Upon removal of the needle 108 and needle hub 106 following successful venipuncture from the catheter hub, one or more leaflets of the valve 120 may close to divide the internal cavity into a distal chamber 368 distal to the valve and a proximal chamber 370 proximal to the valve (FIG. 41). . The side port 360 may be isolated from the proximal chamber 370 (FIG. 40) of the internal cavity by valve 120. However, when the needle is in the catheter tubing and the needle deflects one or more valve leaflets, fluid communication may occur with the proximal chamber 370. Tube 376 (FIG. 42) may be coupled to side port 360, and hydraulic connector 378 (FIG. 42) may be coupled to the opposite end of the tube, as will be described below. The catheter hub 102 with side port 360 and tubing may be called or referred to as a combination catheter 100a.

In fig. 39 also shows a vent plug 112 connected to the proximal opening of the needle hub 106, similar to other vent plugs described herein, and an additional petal grip 372. When included, the petal grip 372 can provide a grip that is closer to the puncture site during insertion of a 108 needle into a vein. In general, the closer to the injection point, the more accurate the injection can be made. When combined, the petal gripper 372 may be integral with the needle hub 106. The petal gripper 372 may be a generally planar structure extending away from the needle hub and having a distally oriented length. The petal grip 372 may have a hump-shaped or curved outer contour with a rounded outer edge, or may have another shape. Superficial tubercles or gripping elements may be included in the petal grip. The petal grip 372 can be adjusted for a left- or right-handed user by rotating the needle hub 102 about the longitudinal axis of the needle 108. In some examples, the petal grip 372 can be formed by a clamp ring, and the clamp ring can slide on the needle hub. The clamp ring may be adjustable or rotatable relative to the needle hub 106 to allow the blade grip 372 to be repositioned as desired by the physician. Examples of adjustable paddle grips are disclosed in U.S. Pub. No. 2017/0173304 A1, the contents of which are expressly incorporated herein by reference.

In fig. 40 is a cross-sectional side view of the catheter assembly 100 of FIG. 39, rotated 90 degrees along the axis of the needle. Various components are shown more clearly, including valve 120, valve actuator 122, and needle guard mechanism 130. Although not shown, a separately formed locking device or an integrally formed locking device may be used to lock the valve 120 into the internal cavity 123 of the catheter hub 102, as described previously herein.

In fig. 41 is a partial expanded view of the catheter assembly of FIG. 40 to more clearly show the various components included in the assembly. As shown, valve 120 may be valve 120 of FIG. 13 and may be supported between the distal bead 173 and the proximal bead 176 a. The valve actuator 122 located proximally from the valve 120 may include a nose portion 150 having an actuator end for pressing into the valve 120 to open one or more slots of the valve disc to deflect two or more leaflets, such as three slots and three leaflets or four slots and four valves Valve actuator 122 may include at least one plunger element 152, preferably two spaced apart plunger elements 152 that may have one or more fluid flow clearances between them. The two plunger elements 152 may be connected or secured by a stabilizing element 158. In the example shown, two stabilizing elements 158 connect two plunger elements 152 at opposite side edges of the plunger elements. Two stabilizing elements 158 and two plunger elements 152 define an internal opening 400 (FIG. 47) that is smaller compared to the dimensions of the needle guard mechanism 130 at the location of the two corner elements 188a, 190a, as previously described. Thus, when the needle 108 moves the two arms 188, 190 of the needle guard 130 laterally, the needle guard prevents the proximal movement of the two stabilizing elements 158 due to the difference in size. As shown, the corner members 188a, 190a are located distal to the two stabilizing members 158, distal to the inner collar 176c within the catheter hub. Thus, in addition to the two stabilizing elements 158, the needle guard mechanism 130 can be held within the catheter hub by the proximal collar 176c in the ready-to-use position and during needle retraction until the needle tip moves proximal to the two distal walls of the two legs and collapses. , as discussed earlier.

In fig. 42 is a perspective view of the catheter assembly 100 with side port 360, also referred to as the combination catheter assembly 100a, of FIG. 39-41. As discussed previously, a tube or length of tube 376 may be connected to a side port 160 at the first end of the tube and to a hydraulic connector 378 at the second end of the tube 376. The hydraulic connector 378 can be a number of different devices, such as a plug baffle or a needleless valve. As shown, the hydraulic connector is a needleless valve 378 including a cavity 380 with a movable piston 382 located within it. The cavity 380 may have an inlet 384 with a Luer cannula for receiving a Luer cone, such as a syringe tip. A syringe may be used to open hydraulic connector 378 without a needle by applying pressure to plunger 382.

When a syringe is inserted into the inlet 384, the luer cone of the syringe presses against the piston 382, opening a path for fluid between the inlet 384 and the outlet of the cavity 380. The outlet of the cavity 380 is connected to the tube 376. Thus, a fluid such as a drug, supplement or medication released from the syringe through the Luer cone may pass through the needleless valve 378, exit through the cavity outlet 380, enter the tube 376 to then flow through the side port 360, then into the distal chamber 368 of the catheter hub 102, and then into the lumen of the tube 104 catheters and get inside the patient.

In use, the subject catheter assembly 100 with side port 360 may be grasped using the petal gripper 372, if provided, and then inserted into the vein using the needle tip and catheter tubing tip. The initial blood backlash may be seen as blood passes through the needle and enters the needle hub. If a primary flash of blood is confirmed, the physician may pull the needle proximally to allow blood to pass between the needle and the catheter tube and check for a secondary flash of blood. If a secondary blood flush is confirmed, the user can insert the catheter assembly further into the vein, advancing the catheter tubing further into the vein to access the vessel. The needle and needle hub can then be completely removed from the catheter tubing and catheter hub. As the needle is retracted, the tip of the needle will move proximally away from the two distal walls of the needle guard, allowing the two arms of the needle guard to converge and release from the stabilizing elements. Because the thickened portion 142 engages an opening on the proximal wall of the needle guard 130, further retraction of the needle will remove the needle guard from the catheter hub as discussed previously.

With needle 108 and needle hub 106 removed and catheter tube 104 positioned in the patient's vein, the assembly of FIG. 39-42 resembles the device shown in FIG. 6, 8, 10, 16, 18, 20, 27, 29, 31 and 36. Upon removal of the needle 108, the plurality of flaps of the valve 120 are deployed or returned to a relaxed state to close the slits and restrict flow proximally and distally through the valve 120 In one example, the drive end 180 on the nose 150 of the valve actuator 122 is located proximally from the valve in the proximal valve actuator position, spaced from the proximally facing surface of the valve, and spaced from the locking device, if provided. The conical surface of the nose portion 150 is also spaced from the locking device, if provided. This distance or clearance between the nose and the locking device, if any, allows the valve actuator 122 to move forward in the distal direction as it is pushed by the luer cone before colliding with the locking device. This arrangement provides space for the valve actuator element to move distally to open the valve. In one example, the distal advancement of the valve actuator stops when the Luer cone contacts the Luer cannula of the catheter hub 102 at the Luer connection, as described herein. As shown in FIG. 41, the drive end 180 of the nose piece 150 may be spaced from the proximally facing surface of the valve 120 in a ready-to-use position where the tip of the needle extends distally from the distal opening of the catheter tubing and is in the proximal valve drive position. In other examples, the drive end 180 may contact the proximally facing surface of the valve 120 before it is advanced distally by the Luer cone. In one example, valve 120 and valve actuator 122 of FIG. 31-35 can be used with the catheter hub of the present embodiment.

In one example, the drip line of the IV set may be connected to the catheter hub 102 through the proximal catheter hub port 136. When the catheter hub is occupied by an IV set, a hydraulic connector 378 connected to the catheter hub via tubing and a side port can be used to administer medication to the patient, for example, through a syringe. Alternatively, the fluid connector 378 may be connected to the drip line of an IV set, and the proximal port 136 of the catheter hub 102 may be used to administer medication, such as through a syringe.

Now with reference to FIG. 43 is a perspective view of a valve actuator 122 in accordance with additional embodiments of the invention. The subject valve actuator 122 is similar to other valve actuators described herein, such as the valve actuator of FIG. 4, 5, 15, 20 and 33, with some exceptions. As shown, the valve actuator 122 includes a nose portion 150 with a drive end 180, a transition portion 296 that increases in section from the nose portion 150 to a larger section in the proximal direction. Two plunger elements 152 may extend from the transition portion 296 in a proximal direction. The present valve device 122 can be used with any of the catheter assemblies described herein, such as a locking device.

As shown, the transition portion 296 has a conical shape with several inclined segments. In other examples, the transition portion 296 may be a smooth curve or a single inclined cone that increases from the nose portion 150 in a proximal direction. The nose portion 150 distal to the transition portion 296 has a generally frusto-conical shape through an opening for fluid flow. The conical surface of the nose portion 150 allows the valve flaps 194 to apply a pair of force components, including a proximally directed force, to return the valve actuator 122 to the proximal position after the Luer cone is withdrawn.

In the example shown, valve actuator 122 includes two stabilizing elements 158. Each stabilizing element 158 is coupled to two plunger elements 152. Compared to stabilizing elements 158 in FIG. 33, at least one of the stabilizing elements 158 of the present valve actuator 122 has a width defined between the distal edge 158 a and the proximal edge 158 b, which may vary along the length of the bridge defining the stabilizing element. For example, the stabilizer element 158 may have a width between a first end and a second end, or two ends, that are attached to two plunger elements, and the width may be narrow near the two ends but wider near the middle of the length. The wider portion 388 of the stabilizer element 158 may be from 25% to 75% of the length of the stabilizer element 158. However, as with the valve actuator of FIG. 33, one or both of the stabilizer elements 158 may be the same width along their entire length, similar to a bridge. , defining the stabilizing element according to Fig. 33. In one example, the wider portion 388 may be centrally located between two ends of the stabilizing element 158. In some examples, a cutout or recess 390 may be provided at the proximal edge 158b of one or both stabilizing elements 158.

In one example and with reference to FIG. 44, the distal edge 158a of the wider portion 388 of the stabilizing element 158 may have a beveled edge 392. The slope of the beveled edge 392 should begin at or near the outer surface of the stabilizing element 158 and slope toward the inner surface of the stabilizing element. element 158. In other words, the tip of the tapered edge 392 should be closer to the outer surface of the stabilizing element 158 than to the inner surface of the stabilizing element 158. As will be discussed in more detail below, the beveled edge configuration 392 may facilitate release of the needle guard mechanism. If there are two stabilizing elements 158, both distal edges of the two stabilizing elements may include a beveled edge 392 shown in FIG. 44.

In some examples, each of the two stabilizer elements 158 of the valve actuator 122 may have the same width along its entire length, and both constant-width stabilizer elements 158 may have a distal edge 158a with a beveled edge 392, as shown in FIG. 44. For example, the distal edges of the two stabilizing elements 158 of FIG. 33 may have a beveled edge 392 shown in FIG. 44. In some examples, the valve actuator 122 may have two stabilizing elements 158, one of which has a uniform width along its entire length and the other a wider portion 388 at a central location along its entire length. One or the other or both of the stabilizing elements 158 may have a distal edge 158a with a bevel 392. In other examples, one or both of the distal edges of two different stabilizing elements 158 may have a typical square or straight up and down edge, which may also allow the needle guard mechanism to be released. , as discussed in more detail below.

As shown, the two plunger elements 152 may have portions that extend proximally from the proximal edge 158 b of the stabilizer element 158. In some examples, the proximal edge 182 of the two plunger elements 152 and the proximal edge 158 b of the stabilizer element 158, or both stabilizer elements, may terminate at generally along one vertical plane. In an embodiment of the invention where the proximal edges end generally along the same plane, the distal edge 158 a of the stabilizing element can be lengthened distally, for example, by increasing the width of the stabilizing element 158. Changing the location of the distal edge 158 a can be used to control the interaction between the needle guard 130 and the stabilizing element 158.

In fig. 45A and 45B show a needle guard mechanism 130 provided in accordance with other embodiments of the invention mounted on a needle and actuated for the needle tip guard mechanism, respectively. The needle guard mechanism 130 may be used with various catheters described herein.

The contemplated needle guard 130 is similar to other needle guards 130 described herein and includes a proximal wall 140 having a perimeter 192 defining an opening for receiving the needle 108 and engaging a thickened portion 142 formed with the needle. Two legs 188, 190 extend distally from the proximal wall 140. Each leg has a distal wall 188 b, 190 b and a corner member 188 a, 190 a located between the distal wall and the elongated leg portion 188 c, 190 c. Ribs or projections 185 may be included in various parts of the needle guard mechanism 130 to provide additional hardness or rigidity. As shown, projections or ridges may be provided on the edges of the proximal wall 140, on each of the two elongated leg portions 188c, 190c, and on the distal walls 188b, 190b. In a preferred embodiment of the invention, each distal wall 188 b, 190 b is provided with a curved edge 188 d, 190 d (Fig. 45 B) such that the curved edge is adjacent to the side surface of the needle when the needle is between two legs, as shown in Fig. . 45 A. The curved edges can be combined with a needle guard so that the needle is not pressed against the edge of the distal wall, which can cause scraping, but is pressed against the flat outer surfaces of the curved edges. In some examples, projections or ridges may be lowered on the distal wall 188 b, such as on the curved edge 188 d of the first leg 188.

The two tabs 188, 190 intersect each other in the side view shown in the retracted or open needle position of FIG. 45 A, and in the protected or protective position of the needle in FIG. 45 B. In other examples, the two legs may extend distal to the proximal wall 140 on respective sides of the needle shaft, but not intersect the needle axis.

In fig. 45 B shows the needle tip retracted proximally to move proximal to the two distal walls 188 b, 190 b. With this movement, the needle no longer displaces the two tabs and they can move closer to each other, which in turn allows the size measured between the two corner elements 188a, 190a to be reduced compared to when the two tabs are displaced by the needle in FIG. . 45 A. The needle 108 is retracted proximally until the profile increment element 142 abuts the perimeter 192 of the opening on the proximal wall 140. As discussed previously, the perimeter 192 has a smaller dimension than the largest cross-sectional dimension of the profile increment element 142. This allows the needle 108 to move proximally to remove the needle guard 130 along with the needle, as discussed previously.

In fig. 45B shows two arms 188, 190 of the needle guard 130 having two different lengths. Thus, in the protected position, the two distal walls 188 b, 190 b overlap when viewed from above the axis of the needle. In one example, the angle between the distal wall 188 b and the elongated portion 188 c of the first tab 188 is greater than the angle between the distal wall 190 b and the elongated portion 190 c of the second tab 190. From the protruding position of the needle tip in FIG. 45 A to the protected position in FIG. 45 B, the needle guard mechanism has a surface located lateral to the needle in the ready-to-use position and extending to a position distal to the tip of the needle in the protective position to protect the tip of the needle from inadvertent puncture.

In one example, each elongated portion of a tab 188a, 190c of two tabs 188a, 190 is generally straight or linear, with a possible slight bend or bend as the needle moves, to a corresponding corner member 188a, 190a. A single radius bend is then made to form a corresponding corner member 188 a, 190 a and a corresponding distal wall 188 b, 190 b. Another single radius bend is made to form a corresponding curved edge 188 d, 190 d. In a section of a corner element, a single-radius bend can have a simple or complex curve. However, unlike the security mechanism 130 in FIG. 4 and 5, which have at least two bends and two changes of direction between the elongated portion of the tab and the distal wall of each tab, the subject needle guard mechanism 130 has one bend and one change of direction between the elongated portion of the tab 188 c, 190 c and the distal wall 188 b, 190 b each paw.

One bend and one change of direction creates a smooth or flat profile between the extension of the tab and the corner piece. The flat profile on the tab should be positioned to minimize contact with the edge of the stabilizing element, such as snagging or snagging, as discussed in more detail below. Thus, each tab may have additional bends or changes in direction beyond the first corner-forming bend, provided that the transition between the elongated portion of the tab 188c, 190c and the first corner-forming bend 188a, 190a is generally flat. or smooth as shown in the illustration to eliminate potential snag points that could cause binding or binding for the typical range of angles at which the needle is oriented during withdrawal, as discussed in more detail below. In general, during use, the needle is pulled straight out of the catheter hub along the same axis. In extreme cases, the needle can be withdrawn at an angle until the needle touches the upper proximal opening of the catheter hub. If the needle is pulled out at an angle greater than just touching the proximal opening of the catheter hub, this is misuse and may cause the needle to bend.

Now with reference to FIG. 46A and 46B, two different perspective views of the needle guard mechanism 130 are shown. The needle safety mechanism of the present embodiment is similar to the needle safety mechanism shown in FIG. 45 A and 45 B, and can be used with the various catheters described herein. The two arms 188, 190 are shown offset from each other without the needle, which typically offsets the arms from each other, to show the features of the distal walls and curved edges, as described in more detail below. The needle guard tabs 188, 190 are shown with a smooth or flat profile between the extended portion of the tab 188 c, 190 c and the corner member 188 a, 190 a, with a single bend or change in direction. As shown, each elongated portion 188 c, 190 c of the first tab 188 and second tab 190 has portions of different widths. Each tab 188, 190 also includes a cutout 396 with a hook-like edge 396a. The cutout or notches 396 on the two tabs allow the two tabs 188, 190 to enclose the needle to provide lateral stability as the needle transitions from a ready-to-use position, where the needle tip is exposed, to a guard position, where the needle tip is protected.

In fig. 46A shows a curved edge 190 d on a second tab 190 with a straight edge 398. However, the curved edge 190 d is configured to rest against the needle with a flat surface adjacent to the edge in a ready-to-use position, as shown in FIG. 45 A. In FIG. 46 B shows a curved edge 188 a on the first leg with an arc-like cutout 402 . The notch 402 may be used to change where the surface of the curved edge contacts the needle rather than the edge, as shown in FIG. 45 A. In some examples, cutout 402 may be missing.

The needle safety mechanism 130 in FIG. 46A and 46B, as well as other needle guards described herein, can be made from stamped metal sheet, such as stainless steel stamped sheet, using a stamping and bending method to form the needle guard of the shape shown.

Next in FIG. 47 in combination with FIG. 43 and 44 show a schematic view in which the needle 108 is retracted proximally at an angle above the center line after successful venipuncture. For example, the catheter assembly 100 of FIG. 47 may be similar to the catheter of FIG. 5 and 39-42 and is shown after successful venipuncture when the needle is retracted at an angle above the center line in a proximal direction to remove the catheter 102 from the hub. FIG. 47 also shows valve 120, valve actuator 122, and needle guard mechanism 130 activated to cover the tip of needle 108. The valve and valve actuator may be similar to those discussed elsewhere in this document. A separately formed or integral locking device may be used to secure the valve within the catheter hub. The needle safety mechanism 130 may be the same as the needle safety mechanism shown and discussed with reference to FIG. 45 A-46 B. In FIG. 47 does not show the catheter tube, but it is implied that it can be used with the catheter hub 102 by means of a metal sleeve.

When the needle tip is retracted proximally from the two distal walls 188 b, 190 b (FIGS. 45 A-46 B) of the needle guard mechanism 130, needle displacement of the two legs 188, 190 is eliminated, allowing the two legs to move closer to each other or touch each other. . This in turn reduces the size measured at the location of the two corner members 188a, 190a, which thus allows the needle guard mechanism 130 to move proximally through the opening 400 defined by the two stabilizing members 158 and the two plunger members 152. However, during retraction of needle 108 and safety mechanism 130 through opening 400, the physician may inadvertently tilt needle 108 during proximal retraction. When this occurs, the needle guard 130 may come into contact with the distal edge 158 a of one or both stabilizer elements 158 during retraction and thus become caught and possibly stuck as a result of contact between the guard and the stabilizer element. This, in turn, will make it difficult to remove the needle guard mechanism 130 through the opening 400.

When the tab of the security mechanism 130 has more than one bend or change of direction at the transition between the elongated portion of the tab 188 c, 190 c and the corner member 188 a, 190 a, as in the security mechanism of FIG. 5, multiple changes in direction may engage the distal edge 158a of the stabilizing member 158 as the guard mechanism is retracted through the opening 400 when withdrawing the needle. This, in turn, requires the user to change the angle of the needle 108 relative to the longitudinal axis of the catheter hub 102 to a value that is less than the maximum angle A while retracting the needle to avoid snagging and interfering with the retraction of the safety mechanism. In contrast, when the security device of FIG. 45 A-46 B is used with a valve actuator 122 having one or two stabilizing elements 158, one bend or change of direction between the extended portion of the tab and the corner element creates a smooth or flat profile that does not easily engage the distal edge 158 a of one or both stabilizing elements 158 during retraction of the needle. Thus, retraction through the opening 400 is facilitated by using a needle guard mechanism having a tab with one bend or change of direction to produce a smooth or flat profile that does not easily engage the distal edge 158a. Thus, the user can set the angle of the needle 108 relative to the longitudinal axis of the catheter hub 102 to the maximum angle B during retraction to avoid snagging and difficulty in retraction. For two identically sized catheter assemblies with identically sized components but different needle guards, one with one bend or change of direction and the other with two or more bends or changes of direction, angle B is greater than angle A.

In fig. 44 in addition to FIG. 47, when the stabilizing member 158 that the guard 130 touches or contacts during proximal retraction has a beveled edge 392, the likelihood that the transition between the corner member and the elongated portion of the guard arm will engage the beveled distal edge 392 is reduced. Thus, even if the guard has two or more bends on the corner member and the catheter assembly has a beveled edge stabilizing member 392, a user holding a catheter assembly of the same size may be able to hold the needle at an angle A' that is greater than angle A Similarly, if the needle guard has only one bend or change of direction to produce a smooth or flat profile that does not easily engage the distal edge 158a, a user holding the same size catheter assembly can hold the needle at a greater angle B' that greater than angle A. Generally speaking, the angle B' associated with a safety device with one bend or change of direction and the valve actuator with a beveled edge stabilizer is greater than the angle A' associated with a safety device with two or more bends or changes of direction and a valve actuator with a beveled edge stabilizing element.

In fig. 48 is an enlarged view of the assembly of FIG. 47.

According to embodiments of the invention, a catheter assembly includes a catheter tube containing a cavity, an opening at a distal end, and a proximal end connected to a catheter hub, wherein the catheter hub includes a catheter body with an outer surface and an inner surface defining an internal cavity having at least one collar; a needle, with a needle tip at the distal end and a proximal end attached to the needle hub; wherein a needle extending through the catheter hub and through the catheter tube and comprising a needle tip protruding distal to the distal end opening in a ready-to-use position; a valve having a valve body including at least one slot, a proximally facing surface and a distally facing surface, located in an internal cavity of the catheter hub; a valve actuator located in an internal cavity of the catheter hub, wherein the valve actuator has a nose portion with an opening and a proximal portion with at least one gap for the flow of fluid passing through or over it, and is movable between a proximal position and a distal position in the internal cavities when pressed with a Luer cone; a needle protection device comprising a protective surface located lateral to the needle in a ready-to-use position and extending to a position distal to the tip of the needle in a protected position to cover the tip of the needle from accidental needlestick injury; wherein said needle guard device has a tab with an angular member between the elongated portion of the tab and the distal wall, and wherein the angular member has one change of direction at a location that can contact a stabilizing member on the valve actuator during retraction of the needle guard mechanism without gripping, obstructing and/or stopping the movement of the needle.

The locking device may be in contact with the valve or mounted to a proximally facing surface of the valve body to retain the valve in an internal cavity of the catheter hub, wherein the locking device may include a lock body comprising an inner surface defining an opening including a fluid path, a distal end and the proximal end.

The catheter hub may have a side port connected to the tubing at a first end. A hydraulic connector can be connected to the second end of the tube. The hydraulic connector may be a needleless connector. The catheter assembly can be called an integrated catheter assembly.

The valve or actuator stabilizing element may have a distal edge. The distal edge may have a beveled edge. The slope of the beveled edge should begin at or near the outer surface of the stabilizing element and bevel toward the inner surface of the stabilizing element. In other words, the tip of the beveled edge should be closer to the outer surface of the stabilizing element than to the inner surface of the stabilizing element.

The needle guard may have a tab with one change of direction between the elongated portion of the tab and the distal wall of the tab to provide a smooth or flat profile on the corner member between the elongated portion of the tab and the distal wall that does not easily engage the distal edge of the valve actuator stabilizing member.

A method for manufacturing an intravenous catheter assembly according to the present invention and its individual components is within the scope of the present invention.

A method for manufacturing an intravenous catheter assembly 100 comprises attaching a catheter tube 104 containing a cavity, an opening at a distal end, and a proximal end attached to the distal end of a catheter hub 102, wherein the catheter hub 102 includes a catheter body 126 with an outer surface and an inner surface defining an internal cavity. 123, containing at least one bead 173; attaching a needle 108 including a needle tip 114 at a distal end and a proximal end attached to a needle hub 106; wherein said needle 108 passes through the catheter hub 102 and through the catheter tube 104 and has a needle tip 114 protruding distally from the opening at the distal end in a ready-to-use position; placing a valve 120 comprising a valve disc 121 in an internal cavity 123 of a catheter hub 102, the valve disc 121 comprising at least one slot 234 and at least two leaflets 194, a proximally facing surface and a distally facing surface, wherein said distal facing surface contacts at least one shoulder 173; extending a skirt portion 250 from the valve disc 121, wherein the skirt portion 250 comprises a wall with an outer surface and an inner surface defining the interior of the skirt, and a proximal end surface 290 of the skirt, said skirt portion 250 being in contact with the inner surface of the catheter hub 102; placing a valve actuator 122 in an internal cavity 123 of the catheter hub 102, the valve actuator 122 having a nose portion 150 at a distal end and a proximal portion 157 located proximal to the nose portion 150; wherein the nose portion 150 includes an opening for fluid flow and an actuator end 180 at the most distal end of the nose portion 150, and the proximal portion 157 has at least one gap for fluid flow through or through it, the valve actuator 122 has a proximal position at internal cavity 123 and is configured to slide to a distal position in the internal cavity 123 when pressed by a medical instrument, with the nose portion 150 located at least partially in the internal part of the skirt in a ready-to-use position; and wherein two spaced apart abutment surfaces 295, 298 are located proximally from the drive end 180 of the valve actuator 122 and proximally from the proximal end surface 290 of the skirt in a ready-to-use position, the abutment surfaces 295, 298 being sized and shaped to fit to the proximal end surface 290 of the skirt when the valve actuator 122 is in the distal position.

The method may further include housing a needle guard mechanism 130 in an internal cavity 123 of the catheter hub 102, the needle guard mechanism having a guard surface located lateral to the needle 108 in a ready-to-use position and extending to a position distal to the needle tip 114 in a guarded position to cover the tip of the 114 needle from an accidental injection.

In this case, the protective mechanism 130 of the needle contains a proximal wall 140 having a perimeter 192 defining the opening, and at least one tab 188, 190 extending distal to the proximal wall 140, and at least one tab 188, 190 contains an elongated part 188 c, 190 from the foot, the distal wall 188 b, 190 b and the corner element 188 a, 190 a, located between the elongated part of the foot and the distal wall, with one bend located between the elongated part of the foot and the distal wall to create a smooth or flat profile at the location of the corner element where the needle guard mechanism contacts the distal edge.

In addition, the method may further comprise the step of forming a side port 360 containing an elongated body 362 with an opening 364 at an angle to the catheter body 126.

When modifiers such as first, second, third, left, right, etc. are used to distinguish similar components or structures, then these modifiers are understood as conventions only to keep track of similar components, but do not structurally distinguish them between themselves or among them unless the context indicates otherwise.

Although limited embodiments of catheter assemblies and components thereof are described and illustrated herein, many modifications and variations will be apparent to those skilled in the art. For example, ported or integrated intravenous catheters with an extension line can be complemented by the invention. Accordingly, it should be understood that catheter assemblies and components thereof constructed in accordance with the principles of the disclosed device, system and method may be implemented differently than specifically described herein. The disclosure of the invention is also defined in the following claims.

Claims (29)

1. Intravenous catheter assembly (100), containing: a catheter tube (104) containing a cavity, an opening at a distal end, and a proximal end connected to the distal end of a catheter hub (102), said catheter hub (102) comprising a catheter body (126) with an outer surface and an inner surface defining an internal cavity (123) containing at least one collar (173); a needle (108) comprising a needle tip (114) at a distal end and a proximal end attached to a needle hub (106); wherein said needle (108) passes through the catheter hub (102) and through the catheter tube (104) and includes a needle tip (114) protruding distally from an opening at the distal end in a ready-to-use position; valve (120) containing a valve disk (121) located in the internal cavity (123) of the catheter sleeve (102), and the valve disk (121) contains at least one slot (234) and at least two leaflets (194), a proximally facing surface and a distally facing surface, said distally facing surface being in contact with at least one collar (173); a skirt section (250) extending from the valve disc (121), wherein the skirt section (250) contains a wall with an outer surface and an inner surface defining the inner part of the skirt, and a proximal end surface (290) of the skirt, wherein said skirt section (250 ) is in contact with the inner surface of the catheter sleeve (102); a valve actuator (122) located in the internal cavity (123) of the catheter sleeve (102), said valve actuator (122) having a nose part (150) at the distal end and a proximal part (157) located proximal to the nose part (150); wherein the nose portion (150) includes an opening for fluid flow and a drive end (180) at the most distal end of the nose portion (150), and the proximal portion (157) has at least one gap for fluid flow through or through it , the valve actuator (122) is located in a proximal position in the internal cavity (123) and is configured to slide to a distal position in the internal cavity (123) when pressed by a medical instrument, wherein the nose portion (150) is located at least partially in the internal portion skirts in a position ready for use; wherein two spaced apart thrust surfaces (295, 298) are located proximally from the drive end (180) of the valve actuator (122) and proximally from the proximal end surface (290) of the skirt in a ready-to-use position, the thrust surfaces (295, 298 ) are sized and shaped to fit the proximal end surface (290) of the skirt when the valve actuator (122) is in the distal position; And wherein the skirt portion (250) provides an axially directed force acting on the valve actuator (122) when stored energy is released onto adjacent surfaces (295, 298) of the valve actuator (122) to return it to the proximal position. 2. The intravenous catheter assembly (100) of claim 1, further comprising a needle guard mechanism (130) comprising a guard surface located lateral to the needle (108) in a ready-to-use position and extending to a position distal to the needle tip (114) in protected position to cover the tip (114) of the needle from inadvertent sticking. 3. The intravenous catheter assembly (100) of any of the preceding claims, wherein the skirt portion has a ramp-shaped cross-section and wherein the proximal end surface (290) of the skirt is located at the proximal end of said ramp-shaped cross-section. 4. The intravenous catheter assembly (100) according to any of the preceding claims, wherein the nose portion (150) of the valve actuator (122) has a first slope extending into the transition portion (296), and the transition portion (296) has a second slope, wherein the second slope and the first slope have different slope values. 5. The intravenous catheter assembly (100) according to any of the preceding claims, wherein the valve disk (121) has a first part (168) of a first thickness and a second part (170) of a second thickness, and wherein the first thickness is greater than the second thickness. 6. The intravenous catheter assembly (100) of claim 5, wherein at least one slot (234) extends through a second portion (170) of the disk (121) of the valve (120). 7. The intravenous catheter assembly (100) of claim 1, wherein the valve actuator (122) comprises at least one stabilizing element (158) with a first end and a second end, a first plunger element (152) and a second plunger element (152 ), wherein the first end of the stabilizing element (158) is connected to the first plunger element (152), the second end of the stabilizing element (158) is connected to the second plunger element (152), and wherein the stabilizing element (158) includes a distal edge (158a) and proximal margin (158b). 8. The intravenous catheter assembly (100) of claim 7, wherein the needle guard mechanism (130) comprises a proximal wall (140) having a perimeter (192) defining the opening, and at least one tab (188, 190), extending distal to the proximal wall (140), wherein at least one tab (188, 190) includes an elongated tab portion (188c, 190c), a distal wall (188b, 190b) and a corner element (188a, 190a) located between the elongated tab portion and a distal wall, with one bend located between the elongated portion of the tab and the distal wall to provide a smooth or flat profile at the location of the corner member where the needle guard mechanism contacts the distal edge. 9. The intravenous catheter assembly (100) of claim 8, wherein the catheter hub (102) includes a side port (360) containing an elongated body (362) with an opening (364), said elongated body (362) extending at an angle to the catheter body (126). 10. The intravenous catheter assembly (100) according to any of the previous paragraphs, further comprising a petal gripper (372) containing a body extending laterally to the axis defined by the needle (108). 11. The intravenous catheter assembly (100) of claim 7, wherein the distal edge (158a) of the stabilizing element (158) includes a beveled edge (392) that originates proximal to the outer surface of the stabilizing element (158) and is beveled toward the inner surface stabilizing element (158). 12. A method for producing an intravenous catheter assembly (100), containing: fastening a catheter tube (104) containing a cavity, an opening at a distal end, and a proximal end connected to the distal end of a catheter hub (102), wherein the catheter hub (102) contains a catheter body (126) with an outer surface and an inner surface defining an internal cavity (123) containing at least one collar (173); securing a needle (108) comprising a needle tip (114) at a distal end and a proximal end attached to a needle hub (106); wherein said needle (108) passes through the catheter hub (102) and through the catheter tube (104) and has a needle tip (114) protruding distally from the opening at the distal end in a ready-to-use position; placing a valve (120) containing a valve disk (121) in the internal cavity (123) of the catheter sleeve (102), wherein the valve disk (121) contains at least one slot (234) and at least two leaflets (194), a proximally facing surface and a distally facing surface, wherein said distally facing surface contacts at least one shoulder (173); extension of the skirt section (250) from the valve disk (121), wherein the skirt section (250) contains a wall with an outer surface and an inner surface defining the inner part of the skirt, and a proximal end surface (290) of the skirt, wherein said skirt section (250) is in contact with the inner surface of the catheter sleeve (102); placing the valve actuator (122) in the internal cavity (123) of the catheter sleeve (102), wherein the valve actuator (122) has a nose part (150) at the distal end and a proximal part (157) located proximal to the nose part (150); wherein the nose portion (150) includes an opening for fluid flow and a drive end (180) at the most distal end of the nose portion (150), and the proximal portion (157) has at least one gap for fluid flow through or through it , the valve actuator (122) has a proximal position in the internal cavity (123) and is configured to slide to a distal position in the internal cavity (123) when pressed by a medical instrument, wherein the nose portion (150) is located at least partially in the internal part of the skirt in a ready-to-use position; wherein two spaced apart thrust surfaces (295, 298) are located proximally from the drive end (180) of the valve actuator (122) and proximally from the proximal end surface (290) of the skirt in a ready-to-use position, the thrust surfaces (295, 298 ) are sized and shaped to fit the proximal end surface (290) of the skirt when the valve actuator (122) is in the distal position; And wherein the skirt portion (250) provides an axially directed force acting on the valve actuator (122) when stored energy is released onto adjacent surfaces (295, 298) of the valve actuator (122) to return it to the proximal position. 13. The method according to claim 12, further comprising placing a needle protection mechanism (130) in the internal cavity (123) of the catheter sleeve (102), wherein the needle protection mechanism has a protective surface located on the side of the needle (108) in a ready-to-use position and extending to a position distal to the needle tip (114) in a protected position to cover the needle tip (114) from accidental puncture. 14. The method of claim 13, further comprising forming a side port (360) containing an elongated body (362) with an opening (364) at an angle to the catheter body (126). 15. The method of claim 13 or 14, wherein the needle guard mechanism (130) comprises a proximal wall (140) having a perimeter (192) defining an opening, and at least one tab (188, 190) extending distal to the proximal wall (140), wherein at least one tab (188, 190) includes an elongated tab portion (188c, 190c), a distal wall (188b, 190b) and a corner element (188a, 190a) located between the elongated tab portion and the distal wall, wherein one bend is located between the elongated portion of the tab and the distal wall to provide a smooth or flat profile at the location of the corner element where the needle guard mechanism contacts the distal edge.