Sheathed needle catheter assembly and related manufacturing method

Abstract

The present invention provides a sheathed needle catheter assembly that holds the partition in place so that the partition can be opened and closed multiple times, even after high pressure has been applied. [Solution] A needle device (100) having a component (124) that provides the function of fixing a valve (120) inside a standard diameter size catheter hub (102), wherein the valve (120) and / or component (124) provide a proximal axial force to return the valve opener (122) from a distal position inside the catheter hub (102) to a proximal position inside the catheter hub (102) when the male luer is detached from the catheter hub (102). Various components can be arranged inside a single hub body catheter hub (102) that restricts fluid flow, allows operation to enable fluid flow, prevents needle stick injury, and a combination of these.

Description

Technical Field

[0001] The present disclosure generally relates to peripheral intravenous catheter assemblies, cannula catheter assemblies with specific discussions related to luer actuating devices, and related methods.

Background Art

[0002] The insertion procedure of an intravenous (IV) catheter assembly includes the following four basic steps. (1) A healthcare worker inserts the needle and catheter together into the patient's vein; (2) After inserting into the vein with the needle tip, the healthcare worker advances the catheter into the patient's vein by pushing the catheter with a finger; (3) The healthcare worker holds the hub end (opposite to the tip end) and removes the needle while applying pressure with a free hand on the patient's skin at the insertion site to stop the blood flow in the catheter; (4) Then, the healthcare worker tapes the exposed end of the catheter (catheter hub) to the patient's skin and connects it to a source of fluid to be administered into the patient's vein.

[0003] One problem is that immediately after withdrawing the needle from the patient's vein, the healthcare worker, who is involved in at least two emergency procedures at this point, has to place the exposed needle tip in a nearby location and deal with the tasks necessary to achieve needle withdrawal. In this connection, the exposed needle tip poses a risk of accidental needle sticks, and in this situation, makes the healthcare worker vulnerable to the transmission of various dangerous blood-borne pathogens including AIDS and hepatitis.

[0004] Another problem is applying finger pressure at the correct position to stop the blood flow through the catheter when the needle is removed and after it is removed. This itself poses a risk of needle-stick injury when the operator's elbow accidentally hits when the needle has been removed, or when the operator tries to reinsert the needle into the catheter while applying finger pressure.

[0005] These sheathed needle catheter assemblies are sometimes used in hospital radiology departments for high-pressure injection for diagnostic purposes. The assemblies must withstand pressures of 3 bar or more. This includes ensuring the septum remains in place so that it can be opened and closed multiple times even after such high-pressure application. [Overview of the Initiative]

[0006] A needle device is disclosed having components that provide a function for securing a valve to a standard diameter Luer tapered catheter hub. The components for securing can be called a securing device and can provide a proximal axial force to return the valve opener from a distal to a proximal position when the male Luer is detached from the catheter hub. Various components can be located inside the catheter hub in a single-piece hub body. Various components may include components that restrict fluid flow, enable fluid flow, prevent needle damage, and combinations thereof.

[0007] The fixing device may include a structure having a surface that forms a bore, and at least a portion of the valve opener is positioned in the bore. The portion of the valve opener located in the bore of the fixing device can be positioned in this manner in both the ready-to-use position and the operating position.

[0008] The fixation device can fix a valve inside the catheter hub. The valve may be a valve disc. In addition to fixing the valve, the fixation device may optionally be configured to apply a proximal force to return a valve opener, which has advanced distally to open one or more valve flaps of the valve, from its distal to its proximal position.

[0009] The fixing device may incorporate one or more leaf springs, which may themselves be coil springs such as inclined coil springs, or O-rings, or may be able to apply force to the flexible part of the valve opener, so that the flexible part provides a proximal force to move the valve opener from a distal position to a proximal position.

[0010] The fixing device may have a body having an outer surface, an inner surface, a proximal end, and a distal end.

[0011] Aspects of the present invention relate to a catheter assembly, the catheter assembly comprising: a catheter tube having a lumen, a distal end opening, and a proximal end attached to a catheter hub, wherein the catheter hub comprises a catheter body having an outer surface and an inner surface forming an internal cavity having at least one shoulder portion; a needle having a needle tip at its distal end and a proximal end attached to a needle hub, the needle having a needle tip that protrudes through the catheter hub and catheter tube and protrudes distally to the distal end opening in a ready-to-use position; a valve having a valve body including at least one slit, a proximal surface, and a distal surface, disposed in the internal cavity of the catheter hub; and the internal cavity of the catheter hub The catheter hub comprises a valve actuator positioned in a cavity, having a nose section having a bore and a proximal section having at least one gap through which a fluid flow passes or across, and being slidable between a proximal and distal position inside the internal cavity when pressed by a male luer; a fixing device for holding the valve within the internal cavity of the catheter hub, which is in contact with or integral with the valve at the proximal surface of the valve body, and comprises a retainer body having an inner surface forming a bore, a fluid path, a distal end, and a proximal end; and a needle guard positioned on the side of the needle in a ready-to-use position and having a protective surface that can be moved to a distal position of the needle tip in a protective position to cover the needle tip from accidental needle sticks.

[0012] The distal end of the retainer body may have an inner diameter (ID) of a first dimension and a proximal end having an ID of a second dimension that is larger than the first dimension.

[0013] The distal end of the retainer body may have an inner diameter (ID) of a first dimension and a proximal end having an ID of a second dimension smaller than the first dimension.

[0014] The fixing device may be a retainer, retaining ring, retaining skirt, O-ring, or inclined coil spring.

[0015] A further aspect of the present invention is a catheter assembly, the catheter assembly comprising: a catheter tube having a lumen, a distal end opening, and a proximal end attached to a catheter hub, wherein the catheter hub comprises a catheter body having an outer surface and an inner surface forming an internal cavity having at least one shoulder portion; a needle having a needle tip at the distal end and a proximal end attached to a needle hub, the needle having a needle tip that protrudes through the catheter hub and catheter tube and protrudes distal to the distal end opening in a ready-to-use position; a valve having a valve body comprising at least one slit and at least two flaps, a proximal surface, and a distal surface, disposed in the internal cavity of the catheter hub; and a valve actuator disposed in the internal cavity of the catheter hub, comprising a nose section having a bore, and at least one gap through which a fluid flow passes or across. The device comprises a valve actuator having a proximal compartment and being slidable between a proximal and distal position inside an internal cavity when pressed by a medical instrument; a retainer body having an inner surface forming a bore and including a fluid path, a distal end, and a proximal end, wherein the distal end of the retainer body is in contact with or integral with the valve at the proximal surface of the valve body to hold the valve within the internal cavity of the catheter hub, and the proximal end of the retainer body is located distal to at least one shoulder of the catheter body and is restricted from being displaced proximal by at least one shoulder, or the retainer device is interference-fitted with the catheter hub to hold the valve within the internal cavity of the catheter hub; and a needle guard having a protective surface positioned on the side of the needle in a ready-to-use position and movable to a distal position of the needle tip in a protective position to cover the needle tip from accidental needle sticks.

[0016] The nose section of the valve opener may have a radially continuous surface. The nose section may have slips or gaps so that the body is not continuous along its entire circumference. The proximal section may be located proximal to the nose section. The proximal section of the valve actuator may have gaps or fluid paths. The proximal section may have two spaced-apart plunger elements.

[0017] Another aspect of the present invention is a catheter assembly, the catheter assembly comprising: a catheter tube having a lumen, a distal end opening, and a proximal end attached to the distal end of a catheter hub, wherein the catheter hub comprises a catheter body having an outer surface and an inner surface forming an internal cavity having at least one shoulder portion; a needle having a needle tip at the distal end and a proximal end attached to a needle hub, the needle having a needle tip that protrudes through the catheter hub and catheter tube and protrudes distally to the distal end opening in a ready-to-use position; and a valve having a disc-shaped valve body, the disc-shaped valve body comprising at least one slit and at least two flaps, a proximal surface, and a distal surface, located in the internal cavity of the catheter hub. The device comprises a valve, a valve actuator positioned in the internal cavity of the catheter hub, having a nose section having a bore and a proximal section having at least one gap through which a fluid flow passes or across, and being slidable between a proximal and distal position inside the internal cavity when pressed by a medical instrument, a fixing device including a metal retainer body including a fluid path, a distal end, and a proximal end, wherein the distal end of the retainer body contacts the proximal surface of a disc-shaped valve body to hold the valve between the distal end of the catheter hub and the fixing device in the internal cavity of the catheter hub, and a needle guard positioned on the side of the needle in the ready-to-use position and having a protective surface that can be moved to a distal position of the needle tip in the protective position to cover the needle tip from accidental needle sticks.

[0018] The nose compartment of the valve actuator may be a contoured nose compartment having a surface such that it compresses at least two flaps against the interior of the catheter hub, or deflects at least the valve flaps distally, thereby compressing the valve axially against the shoulder of the catheter hub.

[0019] More generally, the nose section of a valve actuator disclosed herein can deform the valve to impart stored energy to the valve. The nose section of a valve actuator disclosed herein can deflect or bias the valve to impart stored energy to the valve.

[0020] A further aspect of the present invention is a catheter assembly comprising a catheter tube having a lumen, a distal end opening, and a proximal end attached to a catheter hub, wherein the catheter hub comprises a catheter body having an outer surface and an inner surface forming an internal cavity having at least one shoulder portion; a needle having a needle tip at its distal end and a proximal end attached to a needle hub, the needle having a needle tip that protrudes through the catheter hub and catheter tube and protrudes distally to the distal end opening in a ready-to-use position; and at least one slit, a proximal surface, and a distal surface located in the internal cavity of the catheter hub. The device comprises a valve having a valve body including a surface; a valve actuator disposed in the internal cavity of a catheter hub, having a distal nose section having a bore and a proximal section having at least one gap through which a fluid flow passes or across, and being slidable between a proximal and distal position inside the internal cavity when pressed by the male Luer tip of a medical device; and an inclined coil spring disposed on the side of the proximal surface of the valve, comprising a plurality of coils configured to be compressed by the valve actuator when the valve actuator is pressed to the distal position by the male Luer, and to expand to return the valve actuator to the proximal position.

[0021] The catheter assembly may include a needle guard having a protective surface, which is positioned on the side of the needle in the ready-to-use position and can be moved to a distal position of the needle tip in the protective position to cover the needle tip from accidental needle sticks.

[0022] Another aspect of the present invention is a catheter assembly comprising: a catheter tube having a lumen, a distal end opening, and a proximal end attached to a catheter hub, wherein the catheter hub comprises a catheter body having an outer surface and an inner surface forming an internal cavity having at least one shoulder portion; a needle having a needle tip at the distal end and a proximal end attached to a needle hub, the needle having a needle tip that protrudes through the catheter hub and catheter tube and protrudes distal to the distal end opening in a ready-to-use position; a valve having a valve body disposed in the internal cavity of the catheter hub, comprising at least one slit and at least two flaps, a proximal surface, and a distal surface; and a valve actuator disposed in the internal cavity of the catheter hub. The device comprises a valve actuator having a distal nose section having a bore, a proximal section having at least one gap for a fluid flow through or across it, and being slidable between a proximal and distal position inside the internal cavity when pressed by a medical device, and a retaining skirt section formed by the valve, having an outer surface directly facing the inner surface of the catheter hub and an inner surface directly facing the nose section of the valve actuator, wherein the retaining skirt section is sized and shaped such that it is compressed between the inner surface of the catheter hub and the nose section of the valve actuator when the valve actuator is pressed distally by the male Luer tip of the medical device, and expands to return the valve actuator to the proximal position when the male Luer tip of the medical device is disengaged.

[0023] The skirt section can be sized and shaped such that it is deformed or biased by the nose section of the valve actuator when the valve actuator is pushed distally by the male Luer tip of the medical device, and the skirt section expands to return the valve actuator to its proximal position when the male Luer tip of the medical device is disconnected. The skirt section can be sized and shaped such that it changes from a first size to a second size smaller than the first size by the nose section of the valve actuator when the valve actuator is pushed distally by the male Luer tip of the medical device, and the skirt section expands to return the valve actuator to its proximal position when the male Luer tip of the medical device is disconnected. The changing size can be any dimension of the skirt section undergoing the physical transformation.

[0024] The valve disc may have two or more valve flaps, such as three valve flaps, the two or more valve flaps being sized and shaped such that they are deformed, biased, or deflected by the nose section of the valve actuator when the valve actuator is pushed distally by the male Luer tip of the medical device, and the two or more valve flaps expand or de-bias to return the valve actuator to the proximal position when the male Luer tip of the medical device is disconnected. The valve flaps may be sized and shaped such that they change from a first size to a second size smaller than the first size by the nose section of the valve actuator when the valve actuator is pushed distally by the male Luer tip of the medical device, and the valve flaps expand or bias to return the valve actuator to the proximal position when the male Luer tip of the medical device is disconnected. The changing size can be any dimension of the valve flap that undergoes physical deformation, such as being straight until bent and taking on a smaller physical profile.

[0025] A further aspect of the present invention is a catheter assembly, the catheter assembly comprising a catheter tube having a lumen, a distal end opening, and a proximal end attached to a catheter hub, the catheter hub comprising a catheter body having an outer surface and an inner surface forming an internal cavity having at least one shoulder, a catheter tube, a needle having a needle tip at a distal end and a proximal end attached to a needle hub, the needle protruding through the catheter hub and the catheter tube and having a needle tip protruding distally of the distal end opening in a ready-to-use position, a valve having a disc-shaped valve body, the disc-shaped valve body comprising at least one slit, at least two flaps, a proximal surface, and a distal surface disposed in the internal cavity of the catheter hub, a valve actuator disposed in the internal cavity of the catheter hub, the valve actuator having a nose section and a proximal section having at least one void for fluid flow to pass through or across, and being slidable between a proximal position and a distal position inside the internal cavity when pushed by a medical instrument, and a fixing device comprising a metallic retainer body, the retainer body comprising one or more leaf springs configured to apply an axially directed force vector towards the nose section of the valve actuator to a fluid path, a distal end, a proximal end, and a proximal end.

[0026] The catheter body of the catheter hub according to the present invention can be made from a single hub body having an outer diameter surface that is substantially smaller than a luer thread.

[0027] The single hub body can have a distal end having a catheter tube extending therefrom and a proximal end having a female luer. The single hub body can be formed separately.

[0028] Protrusions for pressing with a fingertip can be incorporated and can extend from the upper part of the catheter hub beyond the outer diameter of the luer thread.

[0029] Another feature of the present invention is a catheter assembly in which an axial force in the proximal direction is applied to the valve opener by a fixing device, a valve, or both the fixing device and the valve to move the valve opener from a distal position to a proximal position.

[0030] The present invention can include a method of making or using a catheter assembly in which an axial force in the proximal direction is applied to the valve opener by a fixing device, a valve, or both the fixing device and the valve to move the valve opener from a distal position to a proximal position.

[0031] The present invention can further include a method for forming and using the catheter assembly provided herein.

[0032] Yet another feature of the present invention is a catheter assembly, the catheter assembly comprising a needle attached to a needle hub, a catheter tube attached to a catheter hub, and a valve and a valve actuator disposed inside the catheter hub, the valve comprising a split disk valve portion, the valve and the valve actuator, and a fixing device for holding the valve inside, wherein the valve actuator is movable to the valve to open the split disk valve portion in an open valve position and movable away from the valve to allow the split disk valve portion to return to the closed valve position multiple times, and the needle projects through the valve, the valve actuator, the catheter hub, and the catheter tube in a ready-to-use position.

[0033] The fixing device disclosed herein can be disposed adjacent to the valve proximally or integrally with the valve proximally to hold the valve within the catheter hub.

[0034] The retaining ring or fixing device of the present invention can comprise one or more leaf springs.

[0035] The retaining ring or fixing device of the present invention may comprise a flange and two or more leaf springs extending from the flange.

[0036] At least one leaf spring of the fixing device may extend proximal to the inner diameter of the flange, proximal to a position radially outside the inner diameter, or proximal to a position radially inside the inner diameter.

[0037] At least one proximal end of the leaf spring can be flared outward or bent so as to move away from the centerline that extends longitudinally through the fixing device.

[0038] The catheter assembly may have a catheter hub that includes a wall having an outer surface and an inner surface forming a bore, and a Luer thread or Luer lug at the proximal Luer opening.

[0039] The outer circumference of the catheter hub can be smaller than the outer diameter of the Luer thread or Luer lug.

[0040] The valve actuator described herein may be movable into the valve when the male Luer tip is connected to the catheter hub, and movable away from the valve when the male Luer tip is disconnected from the catheter hub. The valve actuator may be moved from a distal to a proximal position by a force vector generated by the valve, a force vector generated by the fixation device, or by both the valve and the fixation device.

[0041] The valve can undergo at least three operating cycles, each operating cycle including the movement of a valve opener toward the valve to deflect the valve flap, and the movement toward the valve when the valve closes.

[0042] A further aspect of the present invention is a catheter assembly, the catheter assembly comprising: a catheter tube having a lumen, a distal end opening, and a proximal end attached to a catheter hub, wherein the catheter hub comprises a catheter body having an outer surface and an inner surface forming an internal cavity having at least one shoulder; a needle having a needle tip at the distal end and a proximal end attached to a needle hub, the needle having a needle tip that protrudes through the catheter hub and catheter tube and protrudes distally to the distal end opening in a ready-to-use position; a valve having a valve body, the valve body being located in the internal cavity of the catheter hub and comprising at least one slit, a proximal surface, and a distal surface that abuts a first shoulder at the distal surface of the valve; and a valve for holding the valve within the internal cavity of the catheter hub. A fixing device that abuts and contacts the proximal surface of the main body and the internal cavity of the catheter hub, comprising an elastomer material having elastic properties that store energy when deformed; and a valve actuator disposed in the internal cavity of the catheter hub, having a nose section having a bore for fluid flow and a proximal section having a structure having at least one void for fluid flow through or across the nose section, and being slidable between a proximal and distal position in the internal cavity when pushed by a male luer, wherein the valve actuator is provided with a projection for abutting a second shoulder to restrict the proximal movement of the valve actuator, and the valve actuator comprises a transition section disposed proximal to the nose section and at least one actuation element disposed proximal to the transition section.

[0043] The fixing device can contact the internal cavity of the catheter hub by interfering with the inner diameter of the catheter hub, even without an inner shoulder portion to contact.

[0044] The fixing device can contact the internal cavity of the catheter hub by contacting the inner shoulder portion.

[0045] The fastening device may be an O-ring with a circular, elliptical, or polygonal cross-section. A particular polygonal cross-section may include a square or rectangular cross-section with four sides.

[0046] The structure of a valve actuator can include two spaced-apart acting elements.

[0047] A stabilizing element can connect two working elements to each other, and a through-opening is formed distal to the stabilizing element. In some examples, a second stabilizing element can connect two working elements to each other and form a second through-opening.

[0048] The needle guard can be positioned at least partially within the through-opening of the valve actuator. The needle guard can be positioned at least partially within a second through-opening of the valve actuator.

[0049] The nose section of the valve opener or actuator can be separated from the O-ring before the male lure tip advances the valve actuator.

[0050] The nose section of the valve opener or actuator can be separated from the fixing device before the male lure tip advances the valve actuator.

[0051] The valve may be equipped with multiple valve flaps, and the multiple valve flaps and fixing devices may have energy stored when deformed by the valve actuator.

[0052] The stored energy from both the multiple valve flaps and the locking devices can apply a proximal force to the valve actuator, moving it from a distal position to a proximal position.

[0053] A further aspect of the present invention is a catheter assembly, the catheter assembly comprising: a catheter tube having a lumen, a distal end opening, and a proximal end attached to a catheter hub, wherein the catheter hub comprises a catheter body having an outer surface and an inner surface forming an internal cavity; a needle having a needle tip at its distal end and a proximal end attached to a needle hub, the needle having a needle tip that protrudes through the catheter hub and catheter tube and protrudes distally to the distal end opening in a ready-to-use position; a valve having a valve body, the valve body being located in the internal cavity of the catheter hub and comprising at least one slit and at least two flaps, a proximal surface, and a distal surface that abuts a first shoulder at the distal surface of the valve; and a valve disposed in the internal cavity of the catheter hub. A valve actuator comprising a nose section having a bore for fluid flow and a proximal section having a structure having at least one gap for fluid flow through or across the nose section, and which is slidable between a proximal and distal position in an internal cavity when pressed by a medical instrument; and a fixing device comprising a ring body having a flange having an outer diameter, an inner diameter, and a thickness between the proximal and distal surfaces, and at least one leaf spring extending close to the inner diameter of the flange and extending in the proximal direction, wherein the flange is in contact with the proximal surface of the valve and the internal cavity of the catheter hub, and the leaf spring is spaced apart from the inner surface and the nose section at the proximal position of the valve actuator, and the at least one leaf spring has a length, width, and thickness, the thickness of the spring being approximately equal to the thickness of the flange.

[0054] The fastening device may be an eyelet comprising a flange and at least two leaf springs extending from the flange. It may have three, four, five, or more leaf springs.

[0055] At least one leaf spring may extend proximal to the inner diameter of the eyelet flange, proximal to a position radially outside the inner diameter, or proximal to a position radially inside the inner diameter.

[0056] The flange of the fixing device may have an arc-shaped cross-section such that the distal surface is convex and the proximal surface is concave.

[0057] The fixing device may have at least one leaf spring that extends close to the inner diameter of a flange having an arc-shaped cross-section.

[0058] The fixation device can remain inside the internal cavity of the catheter hub by interfering with the inner surface of the catheter hub. Optionally, the fixation device can abut against the inner shoulder of the catheter hub to remain inside the catheter hub.

[0059] The flange and leaf spring can be formed from the same metal sheet. The flange and leaf spring can be formed integrally. The flange may have a thickness, and each leaf spring may have a thickness, and the thickness of the flange and each leaf spring are the same or approximately the same within the manufacturing tolerance of the metal sheet.

[0060] A needle guard is positioned between the two operating elements of the valve actuator. The needle guard may have at least one arm and a proximal wall having a periphery that forms an opening.

[0061] The change in the needle's external shape can engage with the periphery of the proximal wall of the needle guard.

[0062] A pair of slits or notches may be located on both sides of at least one leaf spring of the eyelet.

[0063] The notch may extend across at least two points on the outer arc of the eyelet flange.

[0064] The notches can be aligned along a radius different from that of at least one leaf spring.

[0065] The fixing device may comprise three spaced leaf springs that extend proximally close to the inner diameter of the flange.

[0066] The outer diameter of the eyelet flange may have at least two notches, and it has three spaced-apart leaf springs, each notch extending across at least two points on the outer arc of the flange.

[0067] The length of the leaf spring in the fixing device can be shorter than the length of the nose section. The leaf spring can only contact the nose section when pressed by the valve actuator, and does not contact any other part or component of the valve actuator.

[0068] Further embodiments of the present invention may include a catheter assembly, the catheter assembly comprising: a catheter tube having a lumen, a distal end opening, and a proximal end attached to the distal end of a catheter hub, wherein the catheter hub comprises a catheter body having an outer surface and an inner surface forming an internal cavity having at least one shoulder portion; a needle having a needle tip at the distal end and a proximal end attached to a needle hub, the needle having the needle tip protruding through the catheter hub and the catheter tube and protruding distal to the distal end opening in a ready-to-use position; and a valve having a valve disc and a skirt section extending from the valve disc, wherein the valve disc comprises at least one slit and at least two flaps, a proximal surface, and a distal surface, the skirt section comprising a wall having an outer surface and an inner surface forming the interior of the skirt, and a proximal end surface of the skirt, the valve wherein the distal surface is first A valve positioned in the internal cavity of a catheter hub, in contact with the shoulder portion and with the skirt portion in contact with the internal cavity; and a valve actuator positioned in the internal cavity of a catheter hub, having a nose portion with an operating end and a bore for fluid flow at its distal end, two spaced shoulder portions located proximal to the operating end, each of which has a contact edge; and a proximal portion having at least one gap for fluid flow through or across, and slidably between a proximal and distal position in the internal cavity when pressed by a medical device, with the nose portion positioned at least partially inside the skirt in the ready-to-use position, wherein the contact edges of the two spaced shoulder portions of the valve actuator are located proximal to the proximal end face of the skirt in the ready-to-use position to press the skirt portion when the valve actuator is advanced by a male Luer tip.

[0069] The needle guard, which has a protective surface, is positioned on the side of the needle in the ready-to-use position and can be moved to a position distal to the needle tip in the protective position to cover the needle tip from accidental needle sticks.

[0070] The skirt section may have a substantially cylindrical shape with a sloping cross-section, and the proximal end face may be located at the proximal end of the sloping cross-section.

[0071] The skirt section of the valve can contact the second shoulder portion inside the internal cavity of the catheter hub.

[0072] The walls of the skirt compartment may have thickness, and the proximal end face of the skirt may be exposed radially inward of the second shoulder portion.

[0073] The nose section of the valve actuator may have a first slope extending into the transition section, the transition section may have a second slope, and the second slope and the first slope may have different slope values.

[0074] The nose section of the valve actuator may have a first slope extending into the transition section, and the transition section may have a section of constant diameter without a slope.

[0075] The valve disc may have a first portion having a first thickness and a second portion having a second thickness, wherein the first thickness is greater than the second thickness.

[0076] One or more slits for forming two or more valve flaps can be formed through a second portion of the valve disc having a second thickness.

[0077] Another aspect of the present invention is a catheter assembly, the catheter assembly comprising: a catheter tube having a lumen, a distal end opening, and a proximal end attached to a catheter hub, wherein the catheter hub comprises a catheter body having an outer surface and an inner surface forming an internal cavity having at least one shoulder portion; a needle having a needle tip at the distal end and a proximal end attached to a needle hub, the needle having a needle tip that protrudes through the catheter hub and catheter tube and protrudes distally to the distal end opening in a ready-to-use position; and a valve having a disc-shaped valve body, the disc-shaped valve body being positioned in the internal cavity of the catheter hub, at least A valve comprising at least one slit and at least two flaps, a proximal surface and a distal surface; a valve actuator disposed in the internal cavity of a catheter hub, having a nose compartment and a proximal compartment having at least one gap through which fluid flow passes or across, and being slidable between a proximal and distal position inside the internal cavity when pressed by a medical device; and a fixing device disposed proximal to the valve, the fixing device comprising a metal ring body having a fluid path, a distal end, a proximal end and at least one leaf spring, the at least one leaf spring formed in the metal ring body and extending proximal inward of the proximal curved lip.

[0078] The ring body of the fixing device may have a proximal edge, and at least two slits are formed through the proximal edge to form at least one leaf spring.

[0079] The fixing device may be equipped with three spaced-apart leaf springs.

[0080] At least one leaf spring may be hinged or pivotable around the metal ring body of the fixing device or flange.

[0081] At least one leaf spring is separated from the metal ring body by at least one slit or notch.

[0082] The fixing device may have a spaced-out proximal compartment between two adjacent leaf springs, and the proximal compartment may have a width greater than the width of either leaf spring.

[0083] At least one leaf spring can be spaced apart from the inner surface of the catheter hub when the fixing device is positioned inside the catheter hub to support or secure the valve.

[0084] At least one leaf spring can be spaced away from the nose section of the valve actuator at a proximal position to the valve actuator and can be in contact with the nose section of the valve actuator at a distal position to the valve actuator.

[0085] There may be two or more leaf springs formed by cutting or having at least four notches through the proximal edge of the ring body. When the proximal edge of the ring body is cut or trimmed, a proximal compartment can be formed at the proximal end of the ring body. The proximal compartment may be located between two adjacent leaf springs. One or more proximal compartments of the ring body allow the curved lip of the ring body to bend during the installation of the fixation device in the catheter hub or when in contact with the nose compartment of a valve actuator.

[0086] The fastening device can embody an eyelet having a flange and two or more leaf springs extending from the flange, the flange having an outer diameter and an inner diameter, and at least one notch can be made in the outer diameter, the notch extending along the arc of the outer diameter through two spaced points.

[0087] The fixing device can embody an eyelet having a flange and two or more leaf springs extending from the flange, the flange having an outer diameter and an inner diameter, and at least one notch can be made in the inner diameter, the notch extending along the arc of the inner diameter through two spaced points. The leaf springs can be positioned between the two spaced points along the arc of the inner diameter.

[0088] The catheter assemblies described herein may also be called needle devices or sheath needle catheter assemblies. The device or assembly may have a catheter hub having a catheter tube, a needle hub to which a needle is attached, and a needle protruding through the lumen of the catheter hub and catheter tube.

[0089] The vent plug can be positioned at the proximal end of the needle hub. The plug can be attached to the proximal opening of the needle hub.

[0090] Further embodiments of the present invention include a catheter assembly comprising a catheter tube having a lumen, a distal end opening, and a proximal end attached to the distal end of a catheter hub, wherein the catheter hub comprises a catheter body having an outer surface and an inner surface forming an internal cavity having at least one shoulder. A needle having a needle tip at its distal end and a proximal end attached to a needle hub, wherein the needle can protrude through the catheter hub and catheter tube, and in a ready-to-use position, the needle tip protrudes distal to the distal end opening. A valve having a valve disc disposed in the internal cavity of a catheter hub, wherein the valve disc may comprise at least one slit and at least two flaps, a proximal surface, and a distal surface, the distal surface being in contact with at least one shoulder. A skirt compartment may extend from the valve disc, the skirt compartment comprising a wall having an outer surface and an inner surface forming the interior of the skirt, and a proximal end surface of the skirt, the skirt compartment being in contact with the inner surface of the catheter hub. Alternatively, a fixing device may be positioned proximal to the valve disc, and the fixing device may comprise a metal ring body, the metal ring body comprising a fluid path and at least one leaf spring having a distal end, a proximal end, and a free end extending proximal inward of the proximal end, and the fixing device fixes the valve from proximal displacement. A valve actuator may be positioned in the internal cavity of the catheter hub, and the valve actuator may have a nose compartment at its distal end and a proximal compartment proximal to the nose compartment. The nose compartment comprises a bore for fluid flow and an operating end at the most distal end of the nose compartment. The proximal compartment may have at least one void for fluid flow through or across it. The valve actuator may be positioned proximal to the internal cavity and slidable to the distal position within the internal cavity when pushed by a medical device. Where a skirt compartment is present, the nose compartment is at least partially positioned inward inside the skirt in the ready-to-use position. Alternatively, if a fixing device is present, the nose section can be positioned inside the metal ring body in the ready-to-use position.When a skirt section is present, two spaced-apart contact surfaces are positioned in the ready-to-use position proximal to the operating end of the valve opener and proximal to the skirt proximal end face, and the contact surfaces are sized and shaped to contact the skirt proximal end face when the valve actuator is in the distal position, or, when a fixing device is present, at least one leaf spring is spaced away from the nose section and biases relative to the nose section when the valve actuator is in the distal position.

[0091] The needle guard may be positioned on the side of the needle in the ready-to-use position and move to a distal position of the needle tip in the protective position, providing a protective surface that covers the needle tip to prevent unintended needle sticks.

[0092] The skirt section may include a sloping cross-section, and the proximal end face of the skirt may be located at the proximal end of the sloping cross-section.

[0093] The nose section of the valve actuator may have a first slope extending into the transition section, the transition section may have a second slope, and the second slope and the first slope may have different slope values.

[0094] The valve disc may have a first portion having a first thickness and a second portion having a second thickness, the first thickness being greater than the second thickness.

[0095] At least one slit can be formed through the second portion of the valve.

[0096] At least one stabilizing element may include a first end connected to a first plunger element of the valve actuator and a second end connected to a second plunger element of the valve actuator, and the stabilizing element may further include a distal edge and a proximal edge.

[0097] The distal end may have a tapered rim. The tapered rim may originate closer to the outer surface than to the inner surface.

[0098] The needle guard may comprise a proximal wall having a periphery forming an opening, and at least one arm extending distally from the proximal wall, wherein the at least one arm comprises an elongated arm portion, a distal wall, and an elbow positioned between the elongated arm portion and the distal wall, and a single bend may be positioned between the elongated arm portion and the distal wall such that the elbow contacts the distal edge of the needle guard forms a smooth or flat outer shape.

[0099] The catheter hub may have a side port having an elongated body with a bore, the elongated body of which may extend at an angle to the catheter body. A tube may be connected to the side port at a first end of the tube. A fluid connector may be connected to a second end of the tube. The fluid connector may be a needleless valve.

[0100] The grip paddle, which has a main body, can extend laterally along the axis formed by the needle.

[0101] The distal edge of the stabilizing element may include a tapered edge that starts near the outer surface of the stabilizing element and slopes toward the inner surface of the stabilizing element.

[0102] A needle guard having a single bend or change of direction in one or both arms may be particularly useful in a valve opener with a stabilizing element. A needle guard having a single bend or change of direction in one or both arms may be particularly useful in a valve opener with a stabilizing element having a distal edge with a tapered edge. The tapered edge and the single bend or change of direction can minimize catch points or snug points between the needle guard and the valve opener during the retraction of the needle guard after successful venipuncture.

[0103] The present invention further includes a method for manufacturing a catheter assembly. This method may include attaching a catheter tube having a lumen, a distal end opening, and a proximal end to the distal end of a catheter hub, the catheter hub comprising a catheter body having an outer surface and an inner surface forming an internal cavity having at least one shoulder. The method may further include attaching a needle having a needle tip at the distal end and a proximal end to a needle hub, the needle having a needle tip that protrudes through the catheter hub and catheter tube and protrudes distal to the distal end opening in a ready-to-use position. The method may further include arranging a valve having a valve disc in the internal cavity of the catheter hub, the valve disc comprising at least one slit and at least two flaps, a proximal surface and a distal surface, the distal surface being in contact with at least one shoulder. The method may further include extending a skirt section from the valve disc, the skirt section comprising a wall having an outer surface and an inner surface forming the interior of the skirt, and a proximal end face of the skirt, the skirt section being in contact with the inner surface of the catheter hub, or further including positioning a fixation device within the internal cavity of the catheter hub and proximal to the valve disc, the fixation device comprising a metal ring body having a fluid path and at least one leaf spring having a distal end, a proximal end, and a free end extending proximal-inward of the proximal end, the fixation device fixing the valve from proximal displacement.The method may further include positioning a valve actuator within the internal cavity of a catheter hub, wherein the valve actuator has a nose compartment at its distal end and a proximal compartment proximal to the nose compartment, the nose compartment comprising a bore for fluid flow and an operating end at the most distal end of the nose compartment, the proximal compartment having at least one void for fluid flow through or across it, the valve actuator having a proximal position within the internal cavity and being slidable to a distal position within the internal cavity when pushed by a medical device, and, when a skirt compartment is present, the nose compartment is located within the skirt in the ready-to-use position If a fixing device is located at least partially inside, the nose section is located inside the metal ring body in the ready-to-use position; if a skirt section is located, two spaced-apart contact surfaces are located in the ready-to-use position near the operating end of the valve opener and near the proximal end face of the skirt; and when the valve actuator is in the distal position, the contact surfaces are sized and shaped to contact the proximal end face of the skirt; or, if a fixing device is located, at least one leaf spring is spaced away from the nose section and biases the nose section when the valve actuator is in the distal position.

[0104] The needle tip's bevel can protrude distal to the catheter tube opening or distal to the catheter tube opening in the ready-to-use position. The ready-to-use position may be a position from which injection or puncture can be performed using the assembly or device. The needle hub can be coupled to the catheter hub at its proximal opening, which may have a female threaded Luer or Luer slip.

[0105] The catheter hub may incorporate a push tab and one or more surface features, such as ribs, for pushing the catheter into the patient's vein and beyond the needle. The needle hub may similarly incorporate surface features for a more secure grip when puncturing a vein and withdrawing the needle from the catheter. Unless otherwise specified, various components of the catheter device or assembly may be fabricated from conventional materials using conventional techniques.

[0106] In this example, a pair of wings can be incorporated into the body of the catheter hub, and each wing can extend laterally along 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 operator, for example with adhesive tape or adhesive bandage, to secure the catheter hub to the patient after successful venipuncture.

[0107] Valves and valve openers can be incorporated into the catheter hub to control the flow of fluid through the catheter hub, for example, to control injection or aspiration through the catheter hub. Needle guards or tip protectors, which may have a surface or wall to prevent accidental contact with the needle tip when the needle is removed from the catheter tube and catheter hub after successful venous puncture, can be incorporated into the catheter device or assembly.

[0108] A needle guard or tip protector can embody a structure having one or more components for preventing accidental contact with the needle tip. For example, the needle guard may protect the needle shaft The needle guard may have a structure or wall that moves from the side and proximal to distal to the needle tip to cover or block the needle tip from unintentional contact. For example, the needle guard may be one of the types described in U.S. Patent No. 10,166,370.

[0109] The catheter hub has a body having an outer surface and an inner surface that forms an internal cavity. One or more shoulders or lips may be incorporated into the hub (hu) and can be used to position a valve opener, valve, and / or needle guard in a ready-to-use position. The needle guard may be positioned inside the catheter hub by a nose section of the needle hub that can protrude into the proximal opening of the catheter hub.

[0110] A needle assembly or catheter assembly may include a catheter hub having an interior with a valve, a valve opener, and a needle guard positioned therein in a ready-to-use position. In the example, the needle guard is optional and can be omitted. In yet another example, the needle guard may be positioned substantially outside the catheter hub. For example, the finger portion or part of the finger portion of the needle guard may be positioned inside the catheter hub, while the rest of the needle guard structure may be positioned outside the catheter hub.

[0111] The catheter apparatus or assembly of the present invention may include a device or structure for fixing or holding a valve inside the catheter hub, which may generally be referred to as a fixing device, fixing ring, or fixing element. The fixing device, ring, or element may have a structure that embodies a retainer, retaining ring, retaining skirt, or O-ring of various possible cross-sections, such as circular, elliptical, square, rectangular, or inclined coil spring.

[0112] The fixation device may be formed separately from the valve, or may be part of the valve, such as being used with the valve, integrated with the valve, or formed integrally with the valve. Unless otherwise indicated in the context, the term fixation device can mean any of the above-described structures and their equivalents for fixing the valve inside the catheter hub, and may optionally include features for cooperating with or generating a force vector to return the valve opener from a distal to a proximal position. In the example, the fixation device is positioned in a straight line with the valve, valve opener, and needle guard.

[0113] In certain cases, the fixation device has a bore or opening for receiving a needle, restricts the proximal movement of the internal valve, assists in returning the valve opener from a distal to a proximal position, or, for both purposes as further described below, contacts both the valve and the inside of the catheter hub. The valve opener or a portion of the valve opener may be positioned inside the bore of the fixation device, both in the ready-to-use position of the catheter assembly and in the use position, such as after successful venipuncture, as further described below.

[0114] The needle guard may comprise a metal body having spring or elastic properties, a proximal wall, and at least one or two arms extending distally from the proximal wall. Changes in shape may be formed on the needle shaft proximal to and near the needle tip and may engage with a periphery forming an opening in the proximal wall to restrict distal movement of the needle guard away from the needle, but allowing the tip to enter the needle guard. Changes in shape may include crimps, material stacking, sleeves, or any other increases in diameter that would be larger than the opening in the proximal wall.

[0115] Valves, valve openers or valve actuators, fixing devices, and needle guards may be configured such that their size and shape are determined to accommodate them inside the catheter hub, and the catheter hub may have a one-piece hub body, such as a single hub body formed integrally, having a proximal opening with a female Luer and a distal end having a catheter tube extending therefrom. The proximal opening may optionally include external threads or lugs. In other examples, the catheter hub may be made from a hub body of multiple parts. For example, the catheter hub may have a first hub body attached to a second hub body by joining or welding to form the body of the catheter hub.

[0116] In the example, a valve actuator may have a nose section at the distal end of the actuator body. The nose section may be elongated, generally cylindrical, or have a draft or taper terminating at an operating end for pushing into the valve to open the valve slit, as will be further described below. The operating end of the nose section may have a blunt distal end face or a sharp edge. A flow path may extend through the nose section for fluid flow. The nose section may have a wall surface with a continuous circumferential or continuous peripheral section forming a lumen or flow path. The wall of the nose section may be without gaps or slits, such as a cylinder with a continuous wall. The nose section may form a bore.

[0117] The walls of the nose compartment may be continuous. However, one or more through-holes may be incorporated into the nose compartment to allow fluid to flow through or across them, for purposes such as flushing. The bore of the nose compartment may have a constant bore diameter or may vary by the taper of the nose compartment. In some examples, multiple spaced slits and / or openings may be provided in the nose compartment, such as through the walls of the nose compartment, to allow flow or fluid outflow.

[0118] The two operating elements or plunger elements may extend proximal to the nose section. For example, the two plunger elements may be formed integrally with the nose section and may extend proximal to the nose section. A gap or space may be provided between the two plunger elements, which may form a retaining space.

[0119] A needle guard or tip protector may be positioned within the holding space or between the two plunger elements. In this example, each of the two plunger elements may include at least two longitudinal edges, which may be spaced apart from one another. The longitudinal edges of the plunger elements may be aligned with the longitudinal axis of the valve opener. A gap or space may be provided between the two plunger elements to function as a flow path for the fluid to pass through or across as it passes through the catheter hub.

[0120] In other examples, there may be two or more gaps or channels formed by the valve opener for fluid flow. In yet another example, two plunger elements may be connected to each other by two bridges, such that the proximal end of the valve opener is a continuous wall structure formed by parts of the two plunger elements and two bridges. In some examples, a single plunger element is used with the valve opener.

[0121] In the example, the projections may extend outward from the outer surface of one or both plunger elements. The projections may extend from the outer surface of each plunger element. Each projection may resemble a tab with a substantially flat edge for contacting a shoulder or lip formed inside the catheter hub. The tab surface and orientation of the projections may allow the valve actuator to be inserted into and mounted within the catheter hub, as will be further described below. The projections may be sized and shaped to contact or abut the shoulder inside the catheter hub to restrict the proximal movement of the valve opener or actuator.

[0122] In the example, the transition section extends from the nose section and widens as the body of the valve opener extends axially in the proximal direction. Two actuation elements may extend from the transition section. Alternatively, the two actuation elements may extend from the nose section without a transition section. In some embodiments, other shapes such as a cuboid, rectangle, cone, pyramidal or chamfered shape can be used for the nose section.

[0123] In the example, the valve actuator or valve opener has a longitudinal axis, and one or more actuating elements extend axially or parallel to the longitudinal axis. In a particular example, two actuating elements are diametrically opposed to each other along the longitudinal axis. In another example, two actuating elements can branch off from each other as they extend proximal. In yet another example, two actuating elements can converge towards each other as they extend proximal.

[0124] The spacing between the two plunger elements can be linear, converging, or diverging, forming a holding space between them. As shown in the figure, the two actuator elements form an outer diameter that is larger than the diameter of the nose section. For example, the diameter formed by the two actuator elements at the proximal end can be larger than the diameter formed by any part of the nose section excluding the protrusion. In some examples, the diameter formed by the two actuator elements is only larger than the working end of the nose section.

[0125] In some examples, the nose section of the valve actuator is provided with a molded contour having a separate line or curve, for example, by forming a recess in the nose section which has a separate contour line or curve. Then, one or more surfaces of the contoured nose section can be used to press the valve, causing the valve to repel, thereby pressing the contoured nose section proximal, and returning the valve actuator to its proximal position.

[0126] In some examples, valve actuators or openers are fabricated from rigid materials such as plastic or metal, and the nose section of the valve actuator incorporates a more flexible section, which is also understood to be more flexible than the rest of the valve actuator. For example, the flexible section may be a strip or band of a material softer than the base material used to fabricate the valve actuator. The flexible section can be added to the valve actuator, such as an elastomer band, or molded together with the valve actuator. The flexible section can help return the valve actuator from a distal to a proximal position.

[0127] In one example, the actuator element is flexible and deflectable, so that when pressed by a syringe tip or a male Luer tip adapter, the actuator element can be damaged or bent. The actuator element may be deflectable by selecting a material having the required elastic properties. In another example, the actuator element may be deflectable by incorporating one or more weakening compartments, for example, by incorporating a structurally thin compartment, by incorporating a notch, by using a smaller cross-section compared to other compartments of the same elongated actuator element, or by a combination thereof. Alternatively, the actuator element may be flexible and deflectable by selecting a material having the required elastic properties and by incorporating one or more weakening compartments.

[0128] In yet another example, each operating element may have two or more different cross-sectional or external shapes along its length. For example, an elongated plunger element may have a square external shape adjacent to a crescent-shaped external shape.

[0129] In this example, the actuating element is rigid and not deflectable or deformable when a load is applied, such as when pushed by the male lure tip. Furthermore, one or more stabilizing elements can be incorporated to increase the rigidity of the two actuating elements. Each of the two actuator elements may have a cross-sectional shape at least at its proximal end that overlaps the pushing end of the male tip, so that the male tip can push the valve actuator into the valve, as will be further described below. The stabilizing element may be located distal to the proximal edge of the actuator element, or may have a proximal edge that is coplanar with the proximal edge of the actuator element.

[0130] The nose section of the valve actuator can be configured to engage with the valve in such a way that it opens the valve flap and the slit formed between them when an axial force is applied to the actuator element by the male tip, such as during insertion of the male Luer connector of an IV drip line or administration set, causing the valve actuator to move into the valve and deflect the valve flap.

[0131] Generally, the nose section of a valve opener is rigid to the more flexible valve, allowing the nose section, more specifically the working end of the nose section, to actuate the valve, such as deflecting one or more flaps and opening one or more slits in the valve. The nose section can be made of an incompressible material such as metal, rigid plastic, or hard elastomer to press and open the valve. However, the nose section may further include a more flexible section. For example, an elastic band, strip, or section can be incorporated into or together with the nose section.

[0132] A pair of opposing bands or stabilizers can be incorporated to connect the two actuating elements at a position along the length of the actuating element between the nose section and the proximal end of the actuating element. In some examples, the stabilizers can be positioned at the proximal ends of the two actuating elements such that the proximal edge of the stabilizer is substantially flush with the proximal end face of the actuating element. The two stabilizer elements or bands can be referred to as the first or upper stabilizer element and the second or lower stabilizer element in the elevation direction.

[0133] In one embodiment, the stabilizer or stabilizer element has an arc-shaped wall surface, forming an arc that substantially follows the internal shape of the catheter hub, and connects one actuating element to the other. The stabilizer or stabilizer element can form a substantially continuous cylindrical portion on the body of the valve actuator, which is formed by two stabilizer elements and two actuating elements and is spaced apart from the nose section of the valve actuator. In other words, the valve actuator can be elongated and may have a radially continuous section and a section having a relief passage or through-passage through the wall of the actuator that is not radially continuous.

[0134] In the example, the stabilizer forms a continuous body section around or radially along the valve actuator, separated from the continuous body section of the nose section, which is also continuous around or radially. Two stabilizers or stabilizer elements, also called bands, can be joined together with two plunger elements to form a ring structure.

[0135] Optionally, the two stabilizers may be slightly offset and angled from each other axially along the length of the valve actuator. In some embodiments, there may be one, three, or a different number of actuating elements or stabilizers. For example, there may be two actuating elements but only one stabilizer or band. In the example, the valve actuator having the stabilizer or stabilizer element and projection is fabricated from plastic, for example, by plastic injection molding.

[0136] A stabilizer can help keep the valve actuator centered within the catheter hub while the actuator or actuator element is moving, such as when the nose compartment is pushed by the male Luer tip to open the valve slit. By remaining centered, the nose compartment can align better with the valve disc, such as the slit in the valve disc, enabling smooth valve operation. The stabilizer can also provide engagement with the interior of the catheter hub via friction to prevent the actuator from sliding proximal after the removal of the male Luer tip. However, as described above, the projection can be incorporated with the valve actuator to hold the valve actuator within the catheter hub in cooperation with the inner shoulder or lip within the catheter hub.

[0137] In one embodiment, the nose section is configured to remain engaged with the valve disc after the valve has been operated and the male lure tip has been removed. For example, the nose section can be positioned between one or more slits in the valve disc and held there by friction. To maintain engagement between the actuator and the valve after operation and removal of the male lure tip, the valve actuator, such as the nose section, can be provided with surface features such as grooves, ridges, or fins.

[0138] Preferably, the valve actuator does not engage with the valve after the male lure tip is removed. Preferably, the valve actuator can move from a distal position pressed against the valve to a proximal position that is separated from the valve or makes minimal contact with the valve but allows the valve flap to return or close the slit.

[0139] When the valve opener returns to its proximal position after the removal of the male Luer tip, the valve can close to prevent or restrict the flow of fluid across the valve. The valve can be reopened by displacing the valve opener distally with a male medical device such as the tip of a syringe or the tip of a dosing set. The valve can undergo multiple operating cycles, as the valve opener can move to a distal position within the valve, for example when pushed by the male Luer tip, to open two or more valve flaps, and can return to its proximal position when the male Luer tip is removed, allowing the valve flaps to loosen or close in the slit. In this example, the valve can undergo two or more operating cycles. For example, the valve can undergo at least two operating cycles, at least three operating cycles, at least four operating cycles, at least five operating cycles, or more. Each operating cycle may include movement of the valve actuator toward or distal to the valve to deflect the valve flaps, and movement of the valve actuator toward or proximal to the valve.

[0140] At least one relief passage, opening, or through-passage may be provided between the transition section of the valve actuator and the proximal end of the valve actuator. The transition section can be understood as the section proximal to the operating distal end, or the section from the nose section to the two stabilizers. In the example, two relief passages or through-passages are incorporated to provide a gap that allows open communication between the internal or central portion of the valve actuator and the inner surface of the catheter hub. In other words, between the continuous section of the nose section and the continuous peripheral section formed by the two stabilizers and plunger elements, there is a stabilization ring, which has one or two relief passages, through-passages, or openings for fluid flow such as flushing. The through-opening or relief passage may also be used to hold the needle guard, if incorporated, and will be discussed further below.

[0141] The stabilizing ring of the valve actuator may have an inner diameter smaller than the diameter formed by the diagonal section or elbow of the two arms of the needle guard when the two arms are biased outward by the sides of the needle shaft in the ready-to-use position. Thus, while installing the needle guard in the retaining space of the valve actuator, the diagonal section or elbow of the needle guard can deflect through the stabilizing ring and enter the opening area formed by the relief passage or through-opening.

[0142] When the tip protector is positioned between the two plunger elements, the two distal walls of the needle guard, more specifically the two diagonal compartments or elbows of the needle guard, are positioned within the relief passages and can engage with the guard engagement surfaces on the inner surface of the catheter hub. This allows the needle guard to protrude from the retaining space of the valve actuator through the two relief passages and engage with the guard engagement surfaces of the catheter hub. Thus, the needle guard can be held inside the catheter hub in the ready-to-use position and during needle retraction after successful venous puncture until the tip of the needle moves proximal to the two distal walls of the needle guard, at which point the needle guard can close the tip of the sheath needle, and the distal end of the needle guard, with a stabilizing ring, becomes smaller in diameter than the inner diameter of the valve opener and is removed along with the needle.

[0143] Undercuts or recessed compartments can be provided in the internal cavity of the catheter hub to accommodate the two diagonal compartments or elbows of the needle guard. Thus, the needle guard can be prevented from sliding proximal during needle retraction after successful venous puncture by the shoulder of the recessed compartment or by any other surface feature inside the catheter hub, such as a guard engagement surface inside the catheter hub. Optionally or alternatively, the distal edges of one or both stabilizers may be provided with restraining surfaces to prevent the needle guard from acting prematurely during needle retraction before the needle tip moves proximal to the two distal walls of the needle guard. In addition to the distal edges, each stabilizer may have a proximal edge.

[0144] When the needle guard is held by the distal edges of one or both stabilizers, the inner surface of the catheter hub may omit one or more engagement mechanisms for accommodating the elbow of the needle guard. In the example, the needle guard can engage with the distal edges of one or both of the two stabilizers and can engage with one or more engagement mechanisms formed on the inside of the catheter hub, such as grooves, lips, or shoulders.

[0145] In some examples, one or both stabilizer elements may have slits or channels, thus dividing the arc-shaped stabilizer or stabilizer element into two segments. Even when one or both stabilizer elements have slits, a stabilizing ring, which may be a discontinuous ring as well as a ring having one or more slots formed through the ring, can still interact with the two elbows to provide a retaining structure to prevent the needle guard from acting prematurely during needle retraction before the needle tip moves proximal to the two distal walls.

[0146] The retaining surfaces of stabilizer elements, such as the distal edge, can be called limiting points, choke gaps, or choke points, because they provide a rigid structure that prevents the needle guard from moving proximal to the choke point unless, or until, the needle guard first acts radially to collapse and reduce its radial profile and then slides proximal to the choke point. In an example, the choke points can restrict the proximal movement of one or two elbows of the needle guard until one or two elbows of the needle guard are deflected and reduce the radial profile of the needle guard. In an example, once the radial profile of the needle guard is reduced, the needle guard can slide through the bore formed by the stabilizing ring from the distal position to the proximal position of the stabilizing ring.

[0147] Valve openers can be made from metal or plastic materials. When made from metal, valve openers can be formed by bending or deep drawing, and the arc-shaped cross section of the actuating element can provide additional rigidity when pressed by a male luer. Each actuating element may include at least two longitudinal edges, and ribs may be provided along one or both of the longitudinal edges to further add structural rigidity. One or more gaps may be provided between any two actuating elements. The gaps can provide space for fluid flow through the gap or space, such as during blood washing or IV infusion. The gaps between actuating elements can form a retaining space for accommodating a tip protector.

[0148] In some embodiments, as will be further described below, most, if not all, of the tip protector is fitted into a retaining space formed by the actuator body between the two plunger elements in the ready-to-use position. This configuration allows for a more compact catheter hub because less longitudinal space is required within the hub to fit both the valve actuator and the tip protector in series longitudinally, or when the two overlap only partially in the axial direction.

[0149] Embodiments of the present invention, including the use of the aforementioned fixing device and various other components, can be used with or on commercially available needle gauges, such as 24-gauge to 14-gauge needles.

[0150] When the tip protector engages only with the distal edge of the relief passage or through-passage within the actuator, no deformation or change in diameter is required on the inner wall of the catheter hub, and the tip protector can be positioned even more proximal in the female Luer tapered section while conforming to the international Luer standard for conical joints, thereby further shortening the overall length of the catheter hub.

[0151] A valve usable in the present invention may have a first portion having a first thickness and a second portion having a second thickness that is thinner than the first thickness, measured perpendicular to an inner plane passing through the diameter of the valve. The second portion having the second thickness may have a substantially constant thickness, but optionally may include a thickness that varies along the cross-section of the valve in the second portion.

[0152] In the example, the second portion is formed by recessing the distal surface of the valve, the proximal surface of the valve, or both surfaces, while the first portion substantially holds the entire width or thickness of the valve between the proximal and distal surfaces. In the example, the recess of the second portion can embody an undercut formed in the valve.

[0153] The appearance of the surface between the first and second parts may resemble a trile clover. The trile clover may be present on the distal surface, the proximal surface, or both surfaces of the bulb. In other examples, the appearance of the proximal surface and / or distal surface may have various contours, just as the trile clover may have various curves, lines, and edge contours.

[0154] In the example, a slit is formed through a thinner second portion of the valve to form a valve flap between adjacent valve slits. In some examples, there may be two or more slits forming one or more valve flaps. For example, the first and second portions of the valve can form a four-leaf clover which may have four slits and four valve flaps. Preferably, the valve may have three slits and three valve flaps. The slits start approximately in the center of the valve and extend radially outward toward the outer circumference of the valve, but may extend to just before the outer circumference of the valve. The length of each slit may vary to form valve flaps of different sizes. The length of the slits may be selected to provide the desired valve flap and valve flap deflection when pressed by the nose section of a valve opener, such as when pressed by the operating distal end of a valve opener.

[0155] The valve may be formed integrally from a single material. Alternatively, the valve may be formed from different materials in different parts for reasons such as improved rigidity or flexibility. The valve can be made from medical-grade elastomer or thermoplastic elastomer (TPE). Embodiments of the valve can be made according to the examples of valves disclosed in PCT application PCT / EP2017 / 070934, published as PCT Publication WO2018 / 033626(A1). Its contents are expressly incorporated herein by reference as if they were fully described.

[0156] The fixing device may be a retaining ring having an annular wall structure with an outer surface and an inner surface forming a bore. In some embodiments, the fixing device for securing the valve inside the catheter hub may be a retaining skirt, an O-ring, or a spring. The valve, valve opener, or valve actuator and the fixing device may vary in shape, style, and features, but may perform the functions described herein in other ways.

[0157] The valve may be the valve disc described above having at least one slit that forms at least two flaps. The valve disc may have three or more slits or split disc valve portions that form three or more flaps, and the surface of the disc may have surface features and thickness that vary along the cross-section of the valve disc. In another example, the valve may have a valve disc and a skirt that extends proximal to the proximal surface of the valve disc.

[0158] The catheter hub provided herein may have a valve, a valve opener, a fixation device, and a needle guard, which may be a single hub body having a distal end having a catheter tube extending therefrom and a proximal opening having a female Luer connector. The valve may be located distal to the fixation device, part of the valve opener may be located within the bore of the fixation device, and the needle guard may be located within the retaining space of the valve opener. In other examples, the needle guard may be omitted or located outside the retaining space, such as in a housing separate from or detachable from the catheter hub.

[0159] In the example, the inside of the catheter hub is provided with one or more shoulders or ledges that can be understood as structural lips or stoppers formed on the inner wall. One or more shoulders can provide engagement points or stopping points for components located inside the internal cavity to prevent the components from moving out of or falling out of the inside of the catheter hub. As shown in the figure, a valve can be positioned in an annular groove and can abut against one of the shoulders to prevent proximal displacement of the valve. The valve can also abut against the shoulder of the catheter hub at its distal side to prevent distal displacement of the outer circumference of the valve.

[0160] An annular ring-shaped fixing device or retaining ring may be positioned adjacent to the valve and, at its proximal end, abut against another shoulder inside the internal cavity of the catheter hub to prevent or limit proximal displacement of the fixing device.

[0161] In one example, the fixation device has a cross-section with a sloped, triangular, or inclined surface, where the higher part of the slope is distal and tapers towards the proximal direction. The fixation device may be made from medical-grade plastic material by methods such as plastic injection. In another example, the fixation device may be made from metal material by methods such as punching, then forging, pressing, or machining. In yet another example, the fixation device may be made from an elastomer material such as an O-ring to provide a proximal force to the valve opener when compressed between the nose section of the valve opener and the inner wall of the distal catheter hub. The O-ring can be deflected or deformed by the valve opener to generate stored energy in the O-ring, which can then be released to apply a proximal force to the valve opener.

[0162] The distal end of the fixation device, the higher portion of the bevel, can abut against the proximal surface of the valve, while the proximal end of the fixation device, the narrower portion of the bevel, can abut against one of the shoulders of the internal cavity. This arrangement of the fixation device can help hold the valve from proximal displacement within the catheter hub. In some examples, the valve can be fixed or supported inside the catheter hub by the fixation device without relying on a separate shoulder abutting the proximal edge of the valve.

[0163] In one example, the fixation device may have slight interference when it first enters the proximal opening end of the catheter hub and may have a sizing fit or slight interference fit with the catheter hub at the final mounting position shown. In yet another example, the fixation device may be held inside the catheter hub and the valve can be fixed from proximal displacement by interference fit with the catheter hub alone, without a separate shoulder portion abutting the proximal end of the fixation device.

[0164] The fixing device can be a retaining ring having a roughly triangular cross-section. In other examples, the cross-section can have different shapes, such as complex shapes.

[0165] In addition to securing the valve within the catheter hub, the retaining ring or retaining device can also function as a return mechanism to assist the valve opener in returning to or moving from a distal to a proximal position. For example, when the valve opener advances with the male Luer tip to open the valve slit, the retaining ring can assist in returning the valve opener to its proximal position after the male Luer tip has been removed from the proximal opening of the catheter hub.

[0166] In some cases, the fixation device simply fixes the valve from proximal movement after removing the male Luer tip from the proximal opening of the catheter hub, while the valve's elasticity returns the valve opener from the distal to the proximal position.

[0167] In some examples, the cross-section of the retaining device can be selected to be a shape other than a triangle. In other examples, the molded cross-section of the retaining ring can be formed as a retaining skirt and become part of the valve. For example, the valve can be formed as both a valve disc and a retaining skirt, for instance, by being integrated or integrally formed.

[0168] In the illustrated example, the length of the valve opener is selected such that the working end at the distal end of the nose section just contacts the valve disc of the valve, and the proximal edges of the two plunger elements just contact the nose section of the needle hub in the ready-to-use position. In other examples, the working end may be slightly separated from the valve disc or slightly pressed against the valve disc, but not substantially deflecting the valve flap to allow the valve flap to close the valve slit.

[0169] In this example, the retaining space of the valve opener can be sized and shaped to accommodate a needle guard. The needle guard can be positioned between the two plunger elements of the valve opener. The needle guard may have a proximal wall and two arms positioned distal to the proximal wall, and can be positioned within the retaining space of the valve opener with the two elbows of the needle guard positioned distal to the two stabilizing elements. Thus, when the needle is pulled in the proximal direction, the two elbows are prevented from moving proximal beyond the two distal edges of the two stabilizing elements, which can act as choke points.

[0170] The radial dimensions of the needle guard at the two elbows can be greater than the inner dimensions of the stabilizing ring, and thus can be physically stopped by the distal edges of the two stabilizer elements. After successful venipuncture, the needle can be removed from the catheter tube and catheter hub, and the needle tip moves proximal to the two distal walls of the needle guard, which then allows the two arms of the needle guard to move inward or fold, reducing the radial dimensions of the two elbows. Almost simultaneously, the change in shape near the needle tip can come into contact with the periphery forming an opening in the proximal wall of the needle guard, and as the needle is further withdrawn, the needle guard is removed along with the needle.

[0171] In the example, when the needle guard is positioned inside the catheter hub, the interior of the catheter hub can be enlarged in a position close to the two elbows. For example, the inner diameter of the catheter hub at the two elbows can be larger than the inner diameter of the catheter hub at the proximal wall of the catheter hub. This space can be incorporated to provide a relief passage or additional space for the needle guard in the standby position. That is, when the relief passage is incorporated, it provides space for the two arms so that they are not compressed or biased inward to the same extent at the two elbows in the ready-to-use position compared to when the relief passage is not provided. This can reduce the resistance between the needle shaft and the two curved ends at the distal wall ends during needle retraction after needle puncture.

[0172] The valve opener is held within the internal cavity of the catheter hub, and its displacement from the proximal opening can be restricted by providing the valve opener with at least one lateral projection to interact with one of the shoulders within the internal cavity. The cross-sectional dimensions of the valve opener at at least one projection can be larger than the cross-sectional dimensions at the shoulder of the catheter hub, thereby providing a physical stop to prevent proximal displacement of the valve opener from the proximal opening of the catheter hub.

[0173] While the needle is retracting, if the valve opener moves proximal, for example, by the elbow of the needle guard pushing proximal to the distal edges of the two stabilizing elements before the needle tip moves proximal to the two distal walls, the projection can be used to limit the overall proximal movement by striking one of the shoulders of the catheter hub. In this example, the valve opener may have two projections, one on each operating element, to interact with the shoulder, which may be in an annular configuration.

[0174] Following the removal of the needle, the multiple valve flaps can return to a rebound or relaxed state, closing the slit and restricting the proximal and distal flow through the valve. The operating end of the nose section of the valve actuator can be positioned within a bore formed by a fixing device before operation, but either separated from or not in contact with the fixing device. The tapered surface of the nose section can also be separated from the fixing device. This space or gap can allow the valve operating element to move distally forward when pushed by the male luer tip before impacting or contacting the fixing device.

[0175] In some cases, the male luer tip abuts against the female luer of the catheter hub, stopping further distal advancement of the male luer tip into the catheter hub before the nose section of the valve actuator contacts or presses against the inside of the fixation device.

[0176] The operating end of the valve actuator can contact the proximal surface of the valve after the needle is removed. In other examples, the operating end can be slightly separated from the proximal surface of the valve after the needle is removed.

[0177] As shown in the figure, the nose section of the valve opener may have a proximal taper that can be spaced away from the tapered surface of the inclined cross-section of the fixing device. The size and shape of the nose section may be shaped to contact the inclined cross-section of the fixing device or to be spaced away from it. Alternatively or in addition, the size and shape of the fixing device may be configured to contact the nose section of the valve actuator when the valve actuator advances into the valve and deflects the valve flap.

[0178] In the example, the nose section may incorporate an elastic band, strip, or other elastic section or band such as a strip, which can generate slight interference when the valve opener advances distally to open the valve and the nose section comes into contact with the fixing device.

[0179] If the longitudinal axis of the catheter hub is considered to be the X-axis and the Y-axis is perpendicular to the X-axis, the shape of the nose section can be selected to deflect the valve flap distally and generate a force vector having both X and Y components. The force vector acting in the X direction, the force vector with an X component, or the proximal force vector can be used to facilitate the return of the valve opener from the distal position where the working end is pushed into the valve and deflects the valve flap to the proximal position as shown.

[0180] The valve flap of a valve, or both the valve flap and the locking mechanism of a valve, can generate a force vector relative to the nose section of the valve opener to return the valve opener from a distal to a proximal position. In yet another example, other parts of the valve besides the valve flap can apply a proximal force to move the valve from a distal to a proximal position.

[0181] In the example, the region or portion within the catheter hub adjacent to the proximal opening may be a female Luer, and is understood to have a structure formed according to the ISO standard for female Luers. The proximal edges of the two plunger elements of the valve opener can be recessed from the proximal opening of the catheter hub, but can also be located within the female Luer. Thus, when the male Luer tip is inserted into the female Luer, the male Luer tip pushes the two plunger elements distally, causing the valve opener to be pushed into the valve and open the valve, for example, by deflecting the valve flap distally and opening one or more slits.

[0182] The male Luer tip can be inserted into the proximal opening of the catheter hub, and the valve opener can be advanced into the valve to open the valve flap, thereby opening fluid communication between the male Luer tip and the lumen of the catheter tube. In practice, the male Luer tip may be the tip or male end of an IV infusion line or administration set attached to an IV bag.

[0183] The fluid may be drawn or aspirated from the catheter hub in a proximal direction, or injected distally through the catheter tube. The male Luer tip may have a threaded collar for engaging with a lug or male thread in the catheter hub to further maintain the valve actuator in a distal position and open the valve.

[0184] In the example, the valve opener is configured to move distally as it is advanced by the male Luer tip. The amount or distance the valve opener moves distally should be sufficient to allow the working end and nose compartment to deflect the valve flap distally, opening the valve slit and then opening fluid communication between the male Luer tip and the catheter tube. In the illustrated example, the working end of the valve opener moves distal to the valve flap, and the valve flap is compressed between the inside of the catheter hub and the tapered surface of the nose compartment, or at least deflected distally by the nose compartment. The valve flap can be deformed by the tapered surface of the nose compartment. In other examples, the working end moves a distance equal to or just before the end of the valve flap, still opening the valve flap and allowing free flow in both the proximal and distal directions.

[0185] When the male lure tip is withdrawn, such as when replacing the IV fluid bag attached to the tip of the male lure, the distal force acting on the proximal edges of the two plunger elements by the male lure tip is removed or stopped, and the female lure is not occupied by any external object. As a result, the valve opener can return to its proximal position and is now vacated by the male lure tip.

[0186] In this example, the elasticity of the valve allows the valve flap to spring back (recoil) to a more relaxed state. This repulsive action of the valve flap and the shape of the nose section of the valve opener allow the valve flap to impart a force vector to the nose section, moving the valve opener from a distal to a proximal position.

[0187] The force vector generated by each valve flap in the nose section of the valve opener when the valve flap rebounds includes a force component substantially parallel to the longitudinal axis of the catheter hub, and is referred herein to as the X-component force vector or proximal force vector. Thus, the X-component force vector generated by the valve flap can move the valve opener from a distal position where the working end and nose section deflect the valve flap distally to open the valve, to a proximal position where the working end and nose section no longer deflect the valve flap.

[0188] In some examples, the nose section of a valve actuator is provided with a molded contour having separate lines or curves, for example, by forming a recess in the nose section having separate contour lines or curves. Then, one or more surfaces of the contoured nose section can be used to press the valve. Pressing the valve can generate multiple compression points. For example, the contoured nose section can be structured to compress the valve flap or deflect the valve flap distally, so that the valve flap can generate a force vector relative to the nose section when the male lure tip is removed and the valve flap can return to their relaxed state.

[0189] The contoured nose section can also compress some or more parts of the valve axially relative to the distal shoulder, thereby imparting a return force in the opposite axial direction when the male lure tip is removed. Thus, the valve alone can push the valve opener proximal when the male lure tip is removed, as the valve is compressed and recoils by the contoured nose section alone or by multiple point sections of the contoured nose section.

[0190] In this example, the valve opener can deflect, deform, or bias the valve, such as by deflecting, deforming, or biasing other parts of the valve, such as the valve flap and the skirt section extending from the valve disc. When one or more of the other parts, such as the valve flap and the skirt section, return to their relaxed or unbiased state, they exert a proximal force on the valve opener, moving it from a distal to a proximal position.

[0191] In some examples, interference between the inclined cross-section of the fixing device and the nose section generates a force vector in the nose section of the valve opener, which includes a force vector with an X component. For example, a valve opener may incorporate an elastic band or one or more elastic strips that are compressed, deformed, or biased by the fixing device when the nose section advances into the fixing device by the male lure tip, imparting stored energy. Thus, in addition to the return force generated by the valve flap of the valve in the nose section of the valve opener, the interference between the fixing device and the nose section of the valve opener generates a return force and contributes to the proximal movement of the valve opener from a distal position where the working end and nose section deflect the valve flap distally to a proximal position where the working end and nose section no longer deflect the valve flap.

[0192] In the proximal position, the valve opener is located inside the catheter hub, and the valve flap generally closes the slit to stop or restrict fluid flow in the proximal and / or distal directions. In some examples, a recess can be provided in the nose compartment, and an elastic strip or band is placed in the recess to form a valve opener having a rigid compartment and a more flexible compartment. In other examples, the nose compartment is co-molded or insert-molded with an elastomer strip or band. An elastic strip or band incorporated into the nose compartment can allow the valve actuator to be pressed against a rigid part or component of the retaining device, generating a return force after the removal of the male luer tip.

[0193] Accordingly, embodiments of the present invention are understood to include a catheter assembly or needle device comprising a catheter hub having a distally extending catheter tube, wherein the catheter hub comprises a body having an outer surface and an inner surface forming an internal cavity. A valve and valve opener may be positioned inside the internal cavity. In an example, a fixing device having a body forming a bore is positioned proximal to the valve. The valve flap of the valve can provide a proximal return force to return the valve opener from a distal to a proximal position.

[0194] Additionally or alternatively, the valve can be axially compressed, deformed, or biased relative to the distal shoulder, and the valve provides an axially directed force relative to the nose section to return the valve opener when the male Luer tip is removed. In an example, the fixation device may provide interference with the valve opener, such as the elastomer portion of the valve opener, when the valve opener advances distally by the male Luer tip to open the valve flap of the valve, and the interference may provide a force vector including a force vector extending substantially parallel to the longitudinal axis of the catheter hub to return the valve opener from the distal position to the proximal position when the male Luer tip is removed from the catheter hub.

[0195] A valve, a valve flap, or a skirt section of a valve can be deflected, biased, or deformed by a first structure that moves within the valve without requiring a second structure to be positioned on the opposite side of the first structure, such as a valve opener, although a second structure may be optionally incorporated. For example, a valve flap can be deflected by a valve opener without a shoulder or rigid surface located on the opposite side of the valve flap to stop the deflection. Other objects, such as a leaf spring deflected, biased, or deformed by the nose section of a valve opener, or a spring ring expanded by the insertion of a tapered section of the nose section, can be deflected, biased, or deformed without an opposing structure.

[0196] In some examples, the nose compartment is either separated from or not in contact with the fixation device, and the return force is provided solely by the valve. The fixation device can further provide a fixing function to secure the valve within the catheter hub and prevent it from being inadvertently displaced proximally, causing it to detach from the catheter hub. The catheter hub may include the catheter hub, valve, valve opener, fixation device, and a needle protruding through the catheter tube. The needle can be attached to the needle hub at its proximal end.

[0197] The valve opener can move to a distal position within the valve to open two or more valve flaps when pressed by the tip of the male lure, and can return to a proximal position when the tip of the male lure is removed to allow the valve flaps to relax or close until closure in the slit, so that the valve can undergo multiple operating cycles. In this example, the valve can undergo two or more operating cycles. For example, the valve can undergo at least two cycles, at least three cycles, at least four cycles, at least five cycles, or more.

[0198] In the example, an annular slit or annular channel may be provided on the proximal surface of the valve. The annular slit may be recessed from the outer circumference of the valve. The annular slit may be provided in the first portion of the valve, which is the thicker portion of the valve than the second portion of the valve. The annular slit may be provided to receive the distal end of a fixing device.

[0199] The fixation device can be a retaining ring having a distal end projecting into an annular slit. In one example, the distal end of the fixation device may be pressed into the annular slit and held therein by compression or interference. In another example, the fixation device may be held within the annular slit using adhesive or bonding. In yet another example, the annular slit is an annular channel and does not grip the fixation device on either its inner or outer surface. For example, the outer surface of the fixation device may be pressed against the annular channel, but the inner surface of the fixation device is spaced apart from the annular channel. This alternative configuration allows the fixation device to push the valve outward relative to the catheter hub without requiring an annular slit to grip both the inner and outer surfaces of the distal end of the fixation device.

[0200] The retaining ring has a length between the proximal and distal ends of the retaining body, and the proximal end of the retaining ring may have a wall with a curved body portion having a substantially constant wall thickness. The wall may have an interior that houses the nose section of the valve opener and forms a bore to allow fluid flow, such as for flushing.

[0201] The walls of the fixation device can be substantially cylindrical except for the proximal end. In this example, the proximal end of the retaining ring may have an outwardly curved lip to secure the retaining ring against the inner shoulder of the catheter hub. When positioned against the inner shoulder, the fixation device can help to prevent the valve from displacing proximal. The valve can be fixed or supported from distal movement by positioning the distal surface of the valve against the shoulder of the catheter hub.

[0202] The fixing device and the nose section of the valve opener can be spaced apart from each other at the proximal position of the valve opener. The gap or space between the two provides clearance for the valve opener to move distally and open the valve, for example, to deflect the valve flap, before contacting or striking the fixing device. The working end of the nose section of the valve actuator can be positioned within the bore formed by the fixing device, but spaced apart from or not in contact with the fixing device. The tapered surface of the nose section can also be spaced apart from the fixing device. This space or gap allows the valve acting element to move distally forward before impacting or contacting the fixing device. The working end can be in contact with the proximal surface of the valve. In other examples, the working end can be slightly spaced apart from the proximal surface of the valve.

[0203] The male Luer tip can be inserted into the proximal end of the opening, and the valve opener can be advanced onto the valve to open the valve flap and open fluid communication between the male Luer tip and the lumen of the catheter tube. The male Luer tip may have a threaded collar for engaging with a lug or male thread in the catheter hub to further maintain the valve actuator in a distal position and open the valve.

[0204] In this example, the valve opener is configured to move distally when the male Luer tip advances. The amount or distance the valve opener moves distally should be sufficient to allow the working end and nose compartment to deflect the valve flap distally, opening the slit and then opening fluid communication between the male Luer tip and the catheter tube. The working end of the valve opener can move distally to the valve flap, so that the valve flap can be compressed or deformed by the tapered surface of the nose compartment, or the valve flap can be deflected or deformed distally by the nose compartment of the valve opener. The working end is equal to or just before the end of the valve flap, but can move a distance sufficient to open the valve for free flow in both directions.

[0205] The curved lip in the fixation device can act as a biasing member. Therefore, when the nose section of a valve actuator or opener is pressed against the curved lip at the proximal end of the fixation device, the curved lip presses the nose section against an elastomer band, strip, or section incorporated into the nose section, imparting a pair of force components or force vectors to the nose section of the valve opener, including a force acting substantially parallel to the longitudinal axis of the catheter hub. In another example, the nose section separates from the fixation device when the male Luer tip contacts the female Luer of the catheter hub. In this situation, the valve can provide the necessary return force to return the valve opener from the distal to the proximal position, and the valve opener can eliminate the flexible section of the nose section.

[0206] When the male lure tip is withdrawn, such as when replacing the IV fluid bag attached to the tip of the male lure, the distal force acting on the proximal edges of the two plunger elements by the male lure tip is removed or stopped, and the female lure is not occupied by any external object. As a result, the valve opener can return to its proximal position and is retracted by the male lure tip.

[0207] In this example, the elasticity of the valve allows the valve flap to rebound (recoil) into a more relaxed state, such as moving to a proximal position. This rebound action of the valve flap, along with the shape of the nose section of the valve opener, allows the valve flap to impart a force vector to the nose section, enabling the valve opener to move from a distal to a proximal position.

[0208] Accordingly, aspects of the present invention are understood to include a catheter assembly or needle device comprising a catheter hub having a catheter tube extending distally, wherein the catheter hub comprises a body having an outer surface and an inner surface forming an internal cavity. A valve and valve opener may be located inside the internal cavity. In an example, a fixing device having a body forming a bore is located proximal to the valve and fixes the valve inside the catheter hub.

[0209] In one example, the fixation device provides interference with the valve opener as it advances distally by the male luer tip. In another example, the male luer tip abuts the female luer of the catheter hub before the nose section of the valve opener contacts the fixation device. The valve opener is configured to open the valve flap of the valve.

[0210] In this example, interference, deflection, biasing, or compression of the valve flap by the valve opener provides a force vector that includes a force vector extending substantially parallel to the longitudinal axis of the catheter hub, causing the valve opener to return from a distal to a proximal position when the male Luer tip is removed from the catheter hub.

[0211] The fixing device may also provide a return force to the nose section, such as a flexible insert, elastic band, or area of ​​material in the nose section of the valve opener, to provide an additional proximal return force. In some examples, the fixing device may incorporate a structure having elastic properties that stores energy when biased, deformed, or deflected by the valve opener, and then releases the stored energy to generate a proximal force on the valve opener, moving the valve opener from a distal to a proximal position.

[0212] As described herein, movement from a distal position to a proximal position, or vice versa, requires physically measurable movement.

[0213] The fixation device can further provide a fixing function to secure the valve within the catheter hub and prevent it from being inadvertently displaced proximally, causing it to detach from the catheter hub. The catheter hub may include the catheter hub, valve, valve opener, fixation device, and a needle protruding through the catheter tube. The needle can be attached to the needle hub at its proximal end.

[0214] The valve opener can move to a distal position within the valve to open two or more valve flaps when pressed by the tip of a male luer, and can return to a proximal position when the tip of the male luer is removed, allowing the valve flaps to relax or close until closure in the slit, so that the valve can undergo multiple operating cycles. In the example, the valve can undergo two or more operating cycles. For example, the valve can undergo at least two operating cycles, at least three operating cycles, at least four operating cycles, at least five operating cycles, or more. Each operating cycle can be defined as the movement of the valve actuator toward the valve to deflect the valve flaps, and the movement toward the valve.

[0215] In a further example, the retaining device may be a retaining ring having a distal end with an outwardly curved lip forming a flange for abutting or contacting the proximal surface of the valve, and a wall or body that tapers in the proximal direction from a first dimension to a second larger dimension. Thus, the wall in this embodiment may resemble a slope having a high portion of the slope at the distal position and tapering as it extends in the proximal direction.

[0216] The proximal end of the fixation device may have a proximal margin that can be sized to abut or press against the inner shoulder of the catheter hub. When positioned against the inner shoulder, the fixation device can help to fix the valve from displacing proximal. Alternatively, if there is a slight interference fit between the proximal and / or distal ends of the fixation device and the inner diameter of the catheter hub, a shoulder is not required to fix the fixation device internally. The valve can be fixed or supported from distal movement by being positioned against the shoulder on the distal surface of the valve.

[0217] The fixing device and the nose section of the valve opener can be spaced apart from each other at a position proximal to the valve opener. The gap or space between the two provides clearance for the valve opener to move distally and open the valve, for example, to deflect the valve flap before closing the gap and contacting or colliding with the fixing device.

[0218] In the proximal position of the valve actuator, the working end of the nose section of the valve actuator may be positioned within a bore formed by the stationary device, but either spaced apart from or not in contact with the stationary device. The tapered surface of the nose section may also be spaced apart from the stationary device. This space or gap allows the valve actuating element to move distally forward before impacting or contacting the stationary device. The working end of the valve actuator may be in contact with the proximal surface of the valve. In other examples, the working end may be slightly spaced apart from the proximal surface of the valve.

[0219] By inserting the male Luer tip into the proximal end of the opening and advancing the valve opener into the valve, the valve flap can be opened, thereby opening fluid communication between the male Luer tip and the lumen of the catheter tube.

[0220] In the example, the valve opener is configured to move distally as it is advanced by the male Luer tip. The amount or distance by which the valve opener moves distally should be sufficient to allow the working end and nose compartment to deflect the valve flap distally, opening the slit and then opening fluid communication between the male Luer tip and the catheter tube. In the example, the working end of the valve opener moves distally to the valve flap, causing the valve flap to be compressed or deformed between the inside of the catheter hub and the tapered surface of the nose compartment, or the valve flap to be deflected distally by the nose compartment of the valve opener.

[0221] In some examples, the nose section of the valve actuator is provided with a molded contour having a separate line or curve, for example, by forming a recess in the nose section having a separate contour line or curve. Then, one or more surfaces of the contoured nose section can be used to press and repel the valve, pressing the contoured nose section proximal and returning the valve actuator to its proximal position. For example, one or more contoured surfaces can generate stored energy by axially compressing, deforming, or biasing the valve against the distal shoulder so that the valve provides an axially directed return force when the male lure tip is removed. In some examples, the operating end is equal to or just before the end of the valve flap, but travels a distance sufficient to open the valve for free flow in both directions.

[0222] In the example, the inclined surface of the fixation device acts as a biasing member. For example, when the nose section is pressed against the inclined surface structure of the fixation device by the male Luer tip, the fixation device exerts an opposing biasing force on the nose section of the actuator, such as on the flexible section located within the nose section. Thus, when the nose section is pressed against the inclined surface in interference, the inclined surface of the fixation device imparts a pair of component forces or force vectors to the nose section, including a force acting substantially parallel to the longitudinal axis of the catheter hub. In some examples, the nose section is separated from the fixation device when the male Luer tip contacts the female Luer of the catheter hub.

[0223] When the male lure tip is withdrawn, such as when replacing the IV fluid bag attached to the tip of the male lure, the distal force acting on the proximal edges of the two plunger elements by the male lure tip is removed or stopped, and the female lure is not occupied by any external object. This allows the valve opener to return to its proximal position and be retracted by the male lure tip. In this example, the elasticity of the valve allows the valve flap to recoil into a more relaxed state.

[0224] The repulsive action of the valve flap and the shape of the nose section of the valve opener allow the valve flap to impart a force vector to the nose section, enabling the valve opener to move from a distal to a proximal position. Furthermore, the inclined structure of the fixing device can apply a return force to the nose section, such as to a flexible section located within the nose section, in order to move the valve opener in the proximal direction and return it to its proximal position.

[0225] Accordingly, aspects of the present invention are understood to include a catheter assembly or needle device comprising a catheter hub having a catheter tube extending distally, and a needle attached to a needle hub, wherein the needle extends through the catheter hub and the catheter tube. The catheter hub comprises a body having an outer surface and an inner surface that forms an internal cavity.

[0226] The valve and valve opener can be positioned inside the internal cavity. In this example, a fixing device having a body that forms a bore is positioned proximal to the valve and fixes the valve within the catheter hub. The fixing device can provide interference with the valve opener when the male Luer tip advances distally to open the valve flap of the valve, and this interference conforms to a vector that includes a force vector extending substantially parallel to the longitudinal axis of the catheter hub in order to return the valve opener from the distal to the proximal position when the male Luer tip is removed from the catheter hub.

[0227] The fixation device can further provide a fixing function to secure the valve within the catheter hub and prevent the valve from being inadvertently displaced proximally, so as not to cause the valve to detach from the catheter hub and return to the valve opener and provide force.

[0228] In this example, the retaining ring has a ring body having a first end or distal end and a second end or proximal end. The ring body may have an external dimension that is substantially constant along the length of the ring body, and this can be substantially cylindrical. Internally, the ring body may have a wall thickness in which the inner diameter of the distal end is smaller than the inner diameter of the proximal end, and the dimension from the distal end to the proximal end decreases.

[0229] The inner surface of the ring body can form a bore, which is configured to accommodate a valve opener. A fluid flow can pass through the bore. The bore of the fixation device can compress or bias the nose section of the valve opener, as described above, to apply a pair of component forces. In another example, the fixation device is sized and shaped such that the male Luer tip is separated from the nose section when it contacts the female Luer of the catheter hub. In this example, the fixation device is made from a medical-grade plastic material. In other examples, the fixation device can be made from a medical-grade elastomer or thermoplastic elastomer (TPE) material. Alternatively, the fixation device may be made from a metal material by punching and bending or machining.

[0230] The cross-section of the ring body may have a beveled or inclined surface on its inner surface. Furthermore, the inclined surface may have a constant incline. In other examples, the incline of the inclined surface is not constant. For example, one or more irregularities or inflection points may exist to create a non-linear contour. Whether or not it has a constant incline, the contour may be selected to generate compression, biasing, or interference between the valve opener and the nose section of the valve opener, such as in a flexible section of the nose section, when the valve opener is pressed against the fixing device. The compression, biasing, or interference with the valve opener may be configured to generate a force vector containing a force substantially parallel to the longitudinal axis of the valve opener. This, in turn, helps the valve opener move from a distal position to a proximal position.

[0231] In some examples, the proximal surface of the valve provided herein may have an annular slit or annular slot for receiving the distal end of the fixing device. In some examples, the annular slot may be an annular channel having a gap that does not grip either the inner or outer surface of the distal end of the fixing device. The fixing device may be made from a thin-walled cylinder of a metal or plastic material, and the proximal end may be curved outward to terminate with a curved lip, as well as a rounded corner.

[0232] The inner surface of the ring body of the fixing device can form a bore, which is configured to house the valve opener and compress or bias the nose section of the valve opener into a flexible section of the nose section, etc., to apply a pair of force components, as described above. The rounded corners of the curved lip can be configured to compress the nose section of the actuator and apply a pair of force components. In another example, the fixing device is sized and shaped such that the male luer tip is separated from the nose section when it contacts the female luer of the catheter hub.

[0233] The curved lip of the fixing device may have an outer diameter, which is smaller than the outer diameter of the valve. Depending on the internal structure of the catheter hub, the size of the curved lip can be adjusted so that, when installed inside the catheter hub, the curved lip abuts against or contacts the inner shoulder of the catheter hub, thereby fixing the retaining ring within the internal cavity of the catheter hub.

[0234] In this example, the ring body of the fixation device has a distal end with a curved lip that forms a flange having a substantially flat wall surface for contacting the surface of the valve, such as by abutting the proximal surface of the valve. The ring body of the fixation device may have a substantially constant wall thickness that tapers outward from a first diameter at the distal end immediately proximal to a second, larger diameter at the proximal end, and has a proximal edge for abutting or contacting the inner shoulder of the catheter hub to hold the fixation device within the catheter hub.

[0235] The wall surface may have an inclined surface, such as a slope. The inner surface of the ring body of the fixing device forms a bore, which is configured to house a valve opener. The bore can compress or bias the nose section of the valve opener, such as a section of the nose section incorporating an elastic strip, band, or material, in order to impart a pair of force components to the valve opener. In another example, the fixing device is sized and shaped such that the male luer tip is separated from the nose section when it contacts the female luer of the catheter hub.

[0236] An inclined coil spring can be used with this catheter assembly or device. An inclined coil spring has multiple interconnected coils, all inclined along substantially the same direction. The spring can be made from a metallic material. An inclined coil spring can have a length configuration with two free ends. An inclined coil spring can also be a ring configuration with the two ends of the spring length connected. Inclined coil springs are well known in the art of springs, and the coils of an inclined coil spring are understood to be radially deflectable or compressible with respect to the ring centerline.

[0237] A spring ring configuration with an inclined coil spring can be incorporated as a fixing device. The inclined coil spring, as a fixing device, can contact the proximal surface of the valve and contact the inner shoulder of the catheter hub, thereby fixing the spring ring inside the hub.

[0238] The proximal surface of the valve may have a mating recess for mating with or supporting the distal arc of the inclined coil spring. At the proximal position of the valve opener, the coil of the inclined coil spring contacts both the inner surface of the catheter hub and / or valve and the nose compartment of the valve opener. In other examples, the coil may be spaced away from the surface of the nose compartment, such as not contacting the nose compartment at the proximal position of the valve opener.

[0239] When the male Luer tip of a medical device is inserted into the catheter hub and the valve flap of the valve is opened or deflected, the inclined coil spring is compressed by the nose section of the valve opener. Each of the multiple coils of the inclined coil spring is compressed radially along the centerline of the spring ring, so the coils of the inclined coil spring are compressed and can be compressed by the nose section of the valve opener.

[0240] Because coils tend to be incompressible or rebound, compression of the coil generates a force vector in the nose compartment. The force vector generated against the nose compartment includes a force approximately parallel to the longitudinal axis of the valve opener. If the coil is compressed along one side by the valve, or if the coil is compressed along one side by the catheter hub, the distal axial force vector opposes the proximal valve surface of the valve, and the proximal force vector opposes the valve opener.

[0241] When the male Luer tip is removed, the spring coil expands and presses against the nose compartment, applying a pair of force components including a proximal axial force vector. This can then help push the valve opener proximal, returning the valve opener to its proximal position and the valve to its closed position. The force generated by the spring ring 244 to move the valve opener after the removal of the male Luer tip can be added to the force generated by the valve flap of the valve returning to a relaxed or closed state to close the valve slit after the removal of the male Luer tip. The proximal force can return the valve opener from its distal position to its proximal position within the catheter hub after the male medical device has been detached from the catheter hub.

[0242] In another example, the valve may be provided with an integrated or integrally formed retaining device. The integrated or integrally formed retaining device may be a retaining skirt compartment having a triangular cross-section. The additional surface area of ​​the outer surface of the skirt compartment, or the retaining device, can help to further retain the valve within the catheter hub when the needle is removed and when the valve opener is pressed by the male Luer tip to open the valve.

[0243] The skirt compartment can be sized such that, when the valve opener is pushed distally by the male Luer tip, the triangular cross-section of the skirt can be compressed, deformed, or biased by the tapered nose compartment and the inside of the catheter hub. Thus, when the male tip, such as the male Luer of a syringe or the tip of a dosing set, is removed, the triangular skirt can expand to impart a pair of component forces to the nose compartment, including a proximal axial force vector. This then helps to push the valve opener proximal, returning the valve opener from its distal position to its proximal position and returning the valve to its closed position.

[0244] In yet another example, a fixation device according to an aspect of the present invention has a ring body having a distal end having a curved lip that forms a flange having a substantially flat wall surface for contacting the surface of a valve. The ring body has a substantially 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, and has a proximal edge that can abut or contact the inner shoulder of the catheter hub to hold the fixation device within the catheter hub. Alternatively, the shoulder may be omitted, and the proximal edge may form an interlocking fit with the inner edge of the catheter hub.

[0245] The wall surface of the ring body may have an inclined surface, such as a slope. The inner surface of the ring body of the fixing device forms a bore, which is configured to house the valve opener and compress or bias the nose section of the valve opener to apply a pair of component forces as described above.

[0246] In this embodiment, two or more leaf springs, for example, three to eight, can be provided as part of the retaining ring for holding the valve. In another example, only one leaf spring may be incorporated. The leaf springs can be formed by forming symmetrical three-sided notches in the ring body and bending the notches inward to form the leaf springs. However, the notches may not be three-sided notches, such as partial circular notches, the notches may be asymmetrical, or they may be larger multi-sided notches. Any number of notches can be used to form leaf springs in the retaining device, with three-sided notches being preferred, and a force vector can be generated in the valve opener. After forming one or more notches, the direction of bending of the notches to form the leaf springs is such that one or more leaf springs can contact the nose section of the valve actuator.

[0247] The leaf spring can be sized such that when the valve opener is pushed distally by the male lure tip, the leaf spring is deformed, deflected, or biased by the tapered nose section of the valve opener. As a result, when the male tip is removed, the leaf spring expands or becomes unbiased, imparting a pair of component forces to the nose section, including a proximal axial force vector.

[0248] The biasing force of the leaf spring helps push the valve opener proximal, returning it from its distal position to its proximal position and returning the valve to its closed position. The force of the leaf spring can be added to the force generated by the valve flaps of the valve returning to their relaxed or closed positions to close the valve slit after the removal of the male lure tip. In embodiments having one or more leaf springs, the nose section can be rigid without having any of the optional flexible one or more sections.

[0249] In the embodiment, the fastening device may be a retaining ring, which may comprise an integrated or integrally formed flexible flap or leaf spring. The fastening device may embody one or more leaf springs extending from a flange into an eyelet.

[0250] Fixation devices having an eyelet configuration can be used with the catheter assemblies described herein. The fixation device has a flange for a ring body having an outer diameter (OD) and an inner diameter (ID) that form an opening. The flange may have a thickness that may be the thickness of the metal sheet used to form the eyelet. The thickness of the flange and the thickness of the leaf spring may be the same or approximately the same. If the flange and the leaf spring are integrally formed from a single metal sheet, the thickness of the flange and the thickness of each leaf spring may be the same within the manufacturing tolerance of the metal sheet thickness.

[0251] In the eyelet embodiment, no cylindrical or elongated hollow body extends from the flange. Instead, two or more leaf springs, e.g., 3 to 8 leaf springs or at least one leaf spring, can extend directly from the flange. The drawing shows four leaf springs incorporated into the flange, with each leaf spring at approximately 90 degrees from the adjacent leaf springs. However, three leaf springs or a different number may be present. The leaf springs can be arranged at equal intervals along the flange contour. The leaf springs can help center the valve actuator relative to the slit in the valve.

[0252] The leaf springs may extend proximal to the flange ID, and each leaf spring may terminate at its proximal edge. The proximal edge of each leaf spring may be flat or rounded.

[0253] The leaf springs can be arranged at equal or approximately equal intervals along the flange ID. The leaf springs can extend at or away from the boundary of the flange ID, for example, due to bending to form the leaf springs, or from slits or notches used to fabricate and recess each leaf spring from the flange ID.

[0254] Each leaf spring can have sufficient width and length to generate a component force in the nose section of the valve opener, and collectively all leaf springs can generate a proximal force that can move the valve opener from a distal to a proximal position after the male lure tip has been removed.

[0255] A pair of internal notches or slits can be provided on the flange ID and both side edges of each leaf spring to allow each leaf spring to have a bend with a bend radius recessed from the flange ID. In other examples, the pair of internal notches can be omitted from the flange ID, and the proximal bend at each bend can be angular (square) or right-angled. Alternatively, if internal notches or insufficient internal notches are not incorporated, the bend radius can extend somewhat inward from the flange ID.

[0256] The retaining ring of the eyelet embodiment can be configured to secure a valve inside the catheter hub, as with other retaining rings discussed elsewhere in this specification. The valve may be supported on its distal surface by an inner shoulder and on its proximal surface by the flange of the retaining ring, which may be supported by the proximal inner shoulder of the flange. Thus, the valve can be fixed or supported inside the catheter hub by a retaining device such as the flange of the retaining device, distally by the shoulder and proximal.

[0257] In the proximal position of the valve opener, the operating end of the valve opener can either contact the proximal surface of the valve or be separated from it by a relatively small distance. Regardless of whether there is contact between the valve opener and the valve in the proximal position of the valve opener, the nose section can be positioned within the boundary formed by the leaf spring, but without contact with the leaf spring. For example, in the proximal position of the valve opener, the nose section can be separated from both the leaf spring and the flange. The separation allows the valve opener to move distally into the valve to open the valve flap before the nose section contacts the leaf spring.

[0258] In the example, the flange of the fixation device may incorporate one or more relief passages or notches on the flange OD. The relief passages can reduce interference between the flange OD and the internal bore of the catheter hub while the fixation device is being installed in the catheter hub. For example, relief passages in the OD allow the flange OD to be more flexible and the portion formed by the notch to bend independently as needed.

[0259] Each notch in the flange OD can be formed as a straight line crossing two points on the arc of the flange OD. In some examples, each notch may have a curved shape, a curve and at least one straight cut, or a complex curved cut. In some examples, each leaf spring in the flange OD may have a notch. In other examples, the notches may be positioned so as not to align with the position of the leaf springs, such as not being directly located on the OD portion at the same ID position as the leaf springs. In yet another example, there may be more or fewer notches than the number of leaf springs.

[0260] At the distal position of the valve opener, the nose compartment can protrude through the valve slit, deflecting the valve flap distally and compressing the valve flap between the nose compartment and the inner surface of the catheter hub, or the valve flap can be deflected or deformed distally by the nose compartment of the valve opener without being compressed against the inner surface.

[0261] The operating end of the valve opener may be located distal to a valve flap deflected distally. In other examples, the operating end may be located in approximately the same axial position as the deflected valve flap or the proximal end of the valve flap, still allowing fluid to flow across the valve in the proximal or distal direction.

[0262] The leaf spring can be positioned in the flange such that when the valve opener is pushed distally by the male Luer tip, the leaf spring is deflected radially outward by the tapered nose section of the valve opener. In one example, the proximal edge of each leaf spring is spaced apart from the inside of the catheter hub when deflected by the nose section of the valve opener. In another example, the proximal edge may be in contact with the inner surface of the catheter hub.

[0263] The deflected leaf spring and deflected valve flap generate stored energy, which, when the male lure tip is removed, can then be used to release the stored energy by pushing the nose section of the valve opener to move the valve opener proximally.

[0264] When the male tip is removed from the catheter hub, the leaf spring can be compressed or de-biased to impart a pair of component forces to the nose compartment, including a proximal axial force vector. The biasing force of the leaf spring can help push the valve opener proximal, return the valve opener from its distal position to its proximal position, and return the valve to its closed position.

[0265] The force generated by the leaf springs of the valve opener's locking device may be added to the force generated by the valve flaps of the valve in the valve opener when the valve flaps return to their relaxed or closed positions to close the valve slit after the removal of the male lure tip. In embodiments having one or more leaf springs in the locking device, the nose section of the valve opener can be rigid without any of the optional flexible one or more sections.

[0266] The valve opener can move to a distal position within the valve to open two or more valve flaps when pressed by the tip of a male lure, and can return to a proximal position when the tip of the male lure is removed, allowing the valve flaps to relax or close the slit, so that the valve can undergo multiple operating cycles. In this example, the valve can undergo two or more operating cycles. For example, the valve can undergo at least three cycles, at least four cycles, at least five cycles, or more. Each operating cycle may include movement of the valve opener toward and away from the valve to deflect the valve flaps.

[0267] In alternative eyelet embodiments, the flange of the fastener or ring, which may have an ID, OD, and thickness, can be molded to have an arcuate or curved cross-section. That is, the distal and proximal surfaces of the flange are arcuate or curved. In this example, the distal surface of the flange has a convex shape, and the proximal surface of the flange has a concave shape. The insertion direction of the fastener and arcuate flange along the cross-section allows the flange OD to advance smoothly toward the inner surface during installation, thus facilitating installation of the molded flange. The curved cross-section can also reinforce the flange against deformation during installation.

[0268] The relief passage or notch in the flange OD of the eyelet does not have to be aligned with the leaf spring. For reference, using the hour hand of a clock, the leaf spring can be positioned at the 2, 4, 8, and 10 o'clock positions along the flange ID, while the notch can be positioned at the 3, 6, 9, and 12 o'clock positions along the flange OD. In other examples, the positions of the leaf spring along the flange ID and the notch along the flange OD may vary. Also, the number of leaf springs and notches may vary, such as having two leaf springs and three notches, or three leaf springs and two notches.

[0269] Due to the curved or arc-shaped cross-section of the alternative eyelet embodiment, the leaf spring can be bent to form a leaf spring with a free end in the proximal direction without the need to include a notch or slit along the flange ID. However, a slit or notch may be incorporated to assist or facilitate the bending of the tab to form the leaf spring.

[0270] In yet another example, the catheter assembly may utilize a fixation device that embodies a retaining ring made of elastomer material. For example, the fixation device may be made of an elastomer material such as an O-ring that can store energy when biased or deformed. Thus, when the elastomer material releases its stored energy, it can impart a proximal force to the valve opener, causing it to move from a distal to a proximal position.

[0271] In this example, an elastomer material that can form an O-ring can be compressed between the nose section of the valve opener and the inner wall of the catheter hub at the distal position of the valve opener. The fixation device can have a structure that embodies an O-ring of various possible cross-sections, such as circular, elliptical, or polygonal shapes such as square, rectangular, or triangular. The fixation device can be an elastomer ring having a circular cross-section. The fixation device is formed separately from the valve and used together with the valve to fix the valve inside the catheter hub.

[0272] A valve used with a catheter hub can be fixed or supported distally by the inner shoulder on the inside of the catheter hub, thereby preventing or limiting distal axial displacement of the outer circumference of the valve, while still allowing the valve flap to flex distally when pressed by a valve opener. The valve can be fixed or supported proximal by a retaining ring or elastomer ring of this embodiment. An elastic ring can be fixed in contact with the inner shoulder on the inside of the catheter hub to prevent proximal displacement of the elastic ring, and therefore the valve.

[0273] The fixing device and the nose section of the valve opener can be spaced apart from each other at a position proximal to the valve opener. The gap or space between the two provides clearance for the valve opener to move distally and open the valve, such as to deflect the valve flap before closing the gap and contacting or colliding the fixing device with the valve opener.

[0274] The working end of the nose section of the valve actuator may be positioned within a bore formed by a stationary device, but either spaced apart from or not in contact with the stationary device. The tapered surface of the nose section may also be spaced apart from the stationary device. This space or gap allows the valve actuating element to move distally forward before impacting or contacting the stationary device. The working end of the valve actuator may be in contact with the proximal surface of the valve. In other examples, the working end may be slightly spaced apart from the proximal surface of the valve.

[0275] The male Luer tips available herein may have a threaded collar for engaging with a lug or male thread in a catheter hub in order to maintain the valve actuator in a distal position and open the valve.

[0276] In this example, the valve opener is configured to move distally as it is advanced by the male Luer tip. The amount or distance the valve opener moves distally should be sufficient to allow the working end and nose compartment to deflect the valve flap distally, opening the slit and subsequently opening fluid communication between the male Luer tip and the catheter tube.

[0277] In some examples, the working end of the valve opener moves distal to the valve flap, allowing the valve flap to be compressed between the inside of the catheter hub and the tapered surface of the nose compartment, or the valve flap is deflected or deformed distally by the nose compartment of the valve opener without being compressed. In some examples, the working end can move a distance equal to or just ahead of the end of the valve flap, but still be able to open the valve sufficiently for free flow in both directions.

[0278] In this example, the elastic ring of the fixation device acts as a biasing member. For example, when the nose section is pressed against the fixation device, compressing or biasing the fixation device between the nose section and the inner surface of the catheter hub, the stored energy is transferred to the elastomer material, which can embody an O-ring and exert a force that biases the nose section of the actuator in the opposite direction. Thus, when the nose section is pressed against the elastomer ring, the elastomer ring can impart a pair of component forces or force vectors to the nose section that may act substantially parallel to the longitudinal axis of the catheter hub in the proximal direction.

[0279] When the male lure tip is withdrawn, such as when replacing the IV fluid bag attached to the tip of the male lure, the distal force acting on the proximal edges of the two plunger elements by the male lure tip is removed or stopped, and the female lure is not occupied by any external object. As a result, the valve opener can return to its proximal position and is now repelled by the male lure tip.

[0280] In this example, the elasticity of the valve allows the valve flap to rebound (recoil) to a more relaxed state, such as moving to close the slit or the valve disc. This rebound action of the valve flap and the shape of the nose section of the valve opener allow the valve flap to impart a force vector to the nose section, moving the valve opener from a distal to a proximal position. Furthermore, as described above, the elasticity of the retaining device can exert a return force on the nose section to move the valve opener in the proximal direction.

[0281] Accordingly, aspects of the present invention are understood to include a catheter assembly or needle device comprising a catheter hub having a catheter tube extending distally, and a needle attached to a needle hub, wherein the needle extends through the catheter hub and the catheter tube. The catheter hub may comprise a body having an outer surface and an inner surface forming an internal cavity. A valve and valve opener may be located inside the internal cavity. In an example, a fixing device having a body forming a bore may be located proximal to the valve to fix the valve within the catheter hub.

[0282] The fixation device can provide interference to the valve opener, or bias the valve opener, or vice versa, when the valve opener advances distally by the male Luer tip to open the valve flap, and when the male Luer tip is removed from the catheter hub, the interference provides a force vector including a vector extending proximal in a direction substantially parallel to the longitudinal axis of the catheter hub to return the valve opener from the distal position to the proximal position.

[0283] The fixation device can further provide a fixation function to secure the valve within the catheter hub and prevent it from being inadvertently displaced proximally, causing it to detach from the catheter hub. Otherwise, if the valve displaces from inside the catheter hub, it may not be able to close properly, potentially causing blood leakage. The fixation device can be made of an elastomer material. The material is preferably in the range of 30 Shore A hardness to 70 Shore A hardness. It may also have a Shore A hardness of less than 30 or greater than 70. In an example, the elastomer material is an O-ring. In a specific example, the O-ring may have a circular cross-section.

[0284] The valve opener can move to a distal position within the valve to open two or more valve flaps when pressed by the tip of a male lure, and can return to a proximal position when the tip of the male lure is removed, allowing the valve flaps to relax or close the slit, so that the valve can undergo multiple operating cycles. In this example, the valve can undergo two or more operating cycles. For example, the valve can undergo at least three cycles, at least four cycles, at least five cycles, or more. Each operating cycle may include movement of the valve opener toward the valve to deflect the valve flaps and movement toward the valve to allow the flaps to close.

[0285] In further embodiments of the catheter assembly, the elastomer material that can form the O-ring may have a substantially square or polygonal cross-section.

[0286] In further embodiments of the present invention, the valve is provided with an integral or integrally formed retaining device. In an example, the integral or integrally formed retaining device may be a retaining skirt compartment formed together with the valve disc. The skirt compartment may have substantially constant thickness and a proximal end face, the proximal end face may be 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 face of the skirt compartment may be thick enough so that a portion of the skirt compartment is radially exposed to the inner shoulder. This exposed portion of the skirt compartment may allow or provide a target against which a valve opener presses to compress, deform, or bias the skirt compartment.

[0287] The valve may have a valve disc and an integrated skirt. In the example, the valve disc and skirt section are formed integrally. The skirt section can be seen as a substantially cylindrical length with an open proximal end. The valve disc may have multiple slits or valve disc slit portions that form multiple valve flaps. In the example, the axial wall thickness of the valve disc may be substantially constant without separate first and second parts as shown elsewhere in this description. However, separate first and second parts can be incorporated into a valve having a valve disc and skirt section.

[0288] In the embodiment, instead of incorporating a substantially constant thickness along the length of the skirt section, the skirt section may incorporate a beveled surface along its cross-section. For example, a valve having a valve disc may have separate first and second parts, and may have a skirt section having a beveled cross-section.

[0289] In an alternative embodiment, the valve opener may have a body comprising a nose section, two plunger elements, two projections, and two stabilizing elements, as other valve openers described elsewhere in this specification. In this alternative embodiment, a transition section is provided proximal to the nose section. The transition section may include a pair of opener shoulders, each having a contact edge. The two opener shoulders may be spaced apart from each other, and the two contact edges may be located on different sides of the nose section at substantially the same axial location or position on the valve opener, such that the valve opener is pressed into the valve at approximately the same time as the male lure tip advances.

[0290] Each opener shoulder may include an inclined or sloping surface extending proximal to the contact edge. Each inclined surface may have a constant or complex inclination. Two opener shoulders may be positioned in the transition section of the valve opener, close to the landing section. Raised lips or ribs may be carefully and sufficiently provided on the body of the valve opener to enhance stability and / or strength.

[0291] The outer diameter (OD) of the landing section can be approximately constant. In some examples, the length of the landing section can have the same OD along its length. In yet other examples, there may be a slightly increasing or slightly decreasing slope. An inclined surface in the landing section can be realized insofar as the landing section does not abut or interfere with the skirt section and / or weaken the transition section, and thus can function as a valve opener. The bores of the nose section and the landing section can have approximately constant inner diameters (ID).

[0292] At the distal, external end of the landing section, the nose section may have a substantially frustoconical structure. The tapered surface of the nose section may allow the valve flap to impart a pair of component forces that can include a proximal force to return the valve opener to its proximal position after the removal of the male lure tip.

[0293] The two contact edges of the two opener shoulders can press against the proximal surface of the valve's skirt compartment as the male Luer tip pushes the valve opener distally into the valve. The overlapping surfaces of the skirt compartment and the opener shoulders can indicate interference or compression of the skirt compartment between the distal shoulder of the catheter hub and the contact edges of the valve opener. Therefore, when the valve is opened by the valve opener, the valve flap is compressed between the nose compartment of the valve opener and the inner surface of the catheter hub, or the valve flap is deflected or deformed distally by the nose compartment of the valve opener, and the skirt compartment is compressed or deformed between the distal shoulder of the catheter hub and the two contact edges of the valve opener.

[0294] In some examples, the two opener shoulders having tapered surfaces and contact edges may be omitted or modified. For example, the nose section may extend directly to the stepped shoulder of the transition section without tapered shoulders. Without tapered shoulders, the contact surface of the stepped shoulder may compress the skirt section. In other examples, the tapered shoulders may have different shapes, such as being substantially square or having a square surface without a tapered surface such that the contact edge is approximately the same height as the shoulder itself. In other words, valve actuators may be provided on both sides of the nose section at the contact edge without tapered shoulders.

[0295] If the contact edge and tapered shoulder are omitted, the end faces of the two stepped shoulders can compress the skirt section. The size and shape of the stepped shoulders and nose section can be adjusted to compress the skirt section when the tapered shoulder is omitted. When using an alternative valve opener without a tapered shoulder, the contact edges of the two stepped shoulders can directly press against the proximal end face of the valve.

[0296] Compression, deflection, deformation, or biasing of various surfaces or portions of the valve when actuated by a valve opener can generate stored energy within the valve. When the male luer tip is removed from the female luer of the catheter hub, the stored energy can be released in a form that allows the valve flap and skirt sections to return to a more relaxed state. As a result, the valve flap can apply a proximal force to the nose section, and the skirt section can apply a proximal force to two abutting edges to move the valve opener from a distal position to a proximal position.

[0297] The valve opener can move distally within the valve to open two or more valve flaps of the valve, such as when pushed by a male luer tip, and the valve opener can return to a proximal position when the male luer tip is removed to allow the valve flap and skirt sections to relax or close the slit, so the valve can undergo multiple actuation cycles. In an example, the valve can undergo two or more actuation cycles. For example, the valve can undergo at least 3 cycles, at least 4 cycles, at least 5 cycles, or more. Each actuation cycle can include movement of the valve actuator to and away from the valve to deflect the valve flap.

[0298] A valve, such as the valve flap or skirt section of a valve, can be deflected, biased, or deformed by a first structure, such as a valve opener, moving over the valve without requiring a second structure to be positioned on the opposite side of the first structure, although a second structure may be optionally incorporated. For example, a valve flap can be deflected by a valve opener as the valve opener moves distally. Thus, the valve flap is deflected distally by the valve opener, with or without the presence of a shoulder or some rigid surface located distal to the valve flap. If there is a shoulder or rigid surface, the valve flap can still be deflected distally by the valve actuator and compressed between the nose section and the shoulder or rigid surface. Other objects, such as a leaf spring deflected, biased, or deformed by the nose section of a valve opener, or a C-ring or helical spring expanded by the insertion of a tapered section of the nose section, can be deflected, biased, or deformed without an opposing structure.

[0299] Embodiments of the present invention may be understood to include a catheter assembly or needle device comprising a catheter hub having a distally extending catheter tube, wherein the catheter hub comprises a body having an outer surface and an inner surface forming an internal cavity. A valve and valve opener may be located inside the internal cavity. In an example, a fixation device may have a body forming a bore located inside the catheter hub and proximal to the valve. In an example, the fixation device may be formed integrally with the valve and may form a skirt compartment. For example, the valve disc may be formed integrally with the valve skirt or skirt compartment, and the valve skirt may function as a fixation device for holding the valve disc inside the catheter hub.

[0300] The valve flap of the valve can impart a return force in the proximal direction to return the valve opener from the distal position to the proximal position. Further, the valve opener can include one or more abutting edges for axially compressing, deforming, or biasing the skirt section against the distal shoulder of the catheter hub. In other words, the valve skirt or skirt section can have a length, and the valve opener can compress or deform the valve skirt during actuation of the valve opener to the distal position to open the valve, reducing the length of the valve skirt from a first length to a shorter second length. When the length of the skirt section is reduced by the valve actuator, the skirt section receives stored energy. Thus, the skirt section provides a force directed in the proximal axial direction against the valve opener when the stored energy is released to one or more abutting edges of the valve opener, etc., to return the valve opener to the proximal position when removing the male luer tip.

[0301] In an example, the fixing device can provide interference with the valve opener, such as an elastomeric portion of the valve opener, when the valve opener is advanced distally by the male luer tip to open the valve flap of the valve, for example, when deflecting the valve flap distally by a nose section. The deflection can provide a force vector including a force vector extending generally parallel to the longitudinal axis of the catheter hub in the proximal direction to return the valve opener from the distal position to the proximal position when the male luer tip is removed from the catheter hub. In the example, the interference, biasing, deflection, or compression provides stored energy to the skirt section of the valve. The stored energy can be released to push one or more abutting surfaces of the valve opener in the proximal axial direction.

[0302] A valve opener may have multiple surfaces, such as a nose section and one or more contact edges, to deform the valve at multiple distinct locations on the valve and supply stored energy to the valve. The deformed surfaces of the valve may include the valve flap and other surfaces of the valve distinct from the valve flap. For example, in addition to the valve flap, the skirt section may be compressed axially by the valve opener.

[0303] A catheter hub may include a catheter hub, a valve, a valve opener, a fixation device, and a needle that protrudes through the catheter tube. The needle can be attached to the needle hub at its proximal end.

[0304] In yet another embodiment of the needle assembly or catheter assembly, the catheter hub, catheter tube, valve, valve opener, and fixation device may be similar to those illustrated and described elsewhere, with some exceptions. In this embodiment, an annular slit or annular channel with an enlarged gap can be provided on the proximal surface of the valve to receive the distal end of the fixation device. That is, the enlarged gap of the annular channel in this embodiment can contact the outer surface of the ring body of the fixation ring, but not the inner surface of the ring body, due to the enlarged gap. The ring body can also contact the end face or distal face of the annular channel to control or set the depth of the annular channel relative to the ring body. This configuration allows the fixation device to hold the valve inside the catheter hub, while relaxing tolerances for forming or fabricating the annular channel or simplifying manufacturing requirements, since the inner surface of the ring body does not need to be gripped by the annular channel. The channel (flow channel) is also easier to form by standard molding techniques than by partially cutting into the valve disc.

[0305] The retaining ring may have a wall having a length between its proximal and distal ends with substantially constant wall thickness, and a curved body portion at the proximal end of the retaining ring. The wall of the ring body may have an inner surface that forms a bore for housing the nose section of the valve opener.

[0306] The walls of the fixation device may be substantially cylindrical, except for the curved body portion at the proximal end. In some examples, the proximal end of the retaining ring may have an outwardly curved lip for fixing the retaining ring to an optional inner shoulder of the catheter hub. When positioned against the inner shoulder, the fixation device can help to prevent the valve from displacing proximal. The valve can be fixed or supported from distal movement by being positioned against the shoulder of the catheter hub on the distal surface of the valve. In some examples, the curved lip of the retaining ring has an interlocking fit with the interior of a catheter hub without a shoulder.

[0307] The fixing device may be provided with one or more leaf springs. Four leaf springs can be fixed and arranged at equal intervals from each other at approximately 2, 6, 8, and 10 o'clock positions. However, the leaf springs can be arranged at different arc positions on the ring body. In the example, the leaf springs can be formed by making at least two cuts in the proximal edge of the ring body. As shown in the figure, the leaf springs are formed from two substantially parallel cuts to allow the metal to be bent to form the leaf springs and to form the two side edges of the leaf springs at the proximal end of the ring body.

[0308] In one example, all leaf springs incorporated into this fixing device can be formed in the same way, for example, by utilizing two substantially parallel cuts. In another example, the cuts may be non-parallel. In yet another example, different combinations of leaf springs can be implemented. For example, a ring body may have two proximal leaf springs having cuts formed through the proximal end of the ring body, and two leaf springs formed between the distal and proximal ends of the ring body.

[0309] In this example, the cut portion for forming the leaf spring may be made through the proximal edge of the ring body, or it may be made near the proximal edge of the ring body but distal to it.

[0310] Further examples include implementing leaf springs with fewer than four leaf springs, such as three, two, or one, or with more than four leaf springs, such as five, six, or seven. Furthermore, the spacing between the cut sections can be varied to change the width or size of the leaf spring, thereby changing the spring force or biasing force generated by the leaf spring.

[0311] A cut through the proximal end for forming a leaf spring may have the advantage of forming a proximal compartment between two adjacent leaf springs. The proximal compartment can deflect or bend when the fixation device is slid into the catheter hub to secure the valve. The ability of the proximal compartment to deflect or bend can reduce the insertion force for setting the fixation device. As in the above or other embodiments, a notch may be provided instead of a slit between the leaf spring and the proximal end of the ring body. This can increase the flexibility of both the leaf spring and the proximal end of the ring body.

[0312] The fixing device and the nose section of the valve opener can be spaced apart from each other at a position proximal to the valve opener. The gap or space between the two can provide clearance for the valve opener to move distally and open the valve, such as to deflect the valve flap, before contacting or striking the fixing device. In the illustrated configuration, the operating end of the nose section of the valve actuator can be positioned within the bore formed by the fixing device, but can be spaced apart from the fixing device or not in contact with the fixing device.

[0313] The operating end and nose section can be spaced apart from the cylinder formed by multiple leaf springs. This space or gap can allow the valve actuation element to move distally forward before impacting or contacting the stationary device, such as before striking the leaf springs. The operating end can contact the proximal surface of the valve in the ready-to-use position. In other examples, the operating end can be slightly spaced apart from the proximal surface of the valve.

[0314] In the example, the valve opener is configured to move distally as it is advanced by the male Luer tip. The amount or distance the valve opener moves distally should be sufficient to allow the working end and nose compartment to deflect the valve flap distally, opening the slit and then opening fluid communication between the male Luer tip and the catheter tube. In the illustrated example, the working end of the valve opener moves distal to the valve flap, allowing the valve flap to be compressed between the inside of the catheter hub and the tapered surface of the nose compartment, or the valve flap to be deflected or deformed distally by the nose compartment of the valve opener, with or without compression. As illustrated, the working end is equal to or just short of the end of the valve flap, but moves a distance sufficient to open the valve for free flow in both directions.

[0315] In this example, the tapered surface of the nose section deflects or biases multiple leaf springs radially outward, providing them with stored energy. The curved lip can act as a biasing member. Thus, upon release of the leaf springs, they impart a pair of component forces or force vectors to the nose section of the valve opener, which may include forces acting proximal to approximately parallel to the longitudinal axis of the catheter hub.

[0316] When the male lure tip is withdrawn, such as when replacing the IV fluid bag attached to the tip of the male lure, the distal force acting on the proximal edges of the two plunger elements by the male lure tip is removed or stopped, and the female lure is not occupied by an external object. This allows the valve opener to return to its proximal position, pushed back by the male lure tip. In this example, the elasticity of the valve allows the valve flap to spring back (recoil) to a more relaxed state by releasing its stored energy. This recoil action of the valve flap and the shape of the nose section of the valve opener may allow the valve flap to impart a force vector to the nose section, moving the valve opener from the distal to the proximal position. Furthermore, one or more leaf springs acting on the nose section can also apply a proximal force, further assisting in returning the valve opener to its proximal position.

[0317] The valve opener can move to a distal position within the valve to open two or more valve flaps when pressed by the tip of a male luer, and can return to a proximal position when the tip of the male luer is removed, allowing the valve flaps to relax or close until closure in the slit, so that the valve can undergo multiple operating cycles. In this example, the valve can undergo two or more operating cycles. For example, the valve can undergo at least three cycles, at least four cycles, at least five cycles, or more. Each operating cycle may include movement of the valve actuator toward the valve to deflect the valve flaps and movement toward the valve to allow the valve flaps to close.

[0318] A further aspect of the present invention is a catheter assembly comprising a hub body of a catheter hub having a side port facing in the proximal direction and having an elongated body formed at an acute angle with respect to the longitudinal axis of the hub body. The side port can be formed integrally with the hub body of the catheter hub. A catheter hub having a side port is sometimes referred to as an integral catheter, as will be further described below, or may be referred to as an integral catheter.

[0319] Components similar to other catheter hubs described elsewhere in this specification can be disposed inside the catheter hub of an integral catheter having a side port. For example, the catheter hub of the integral catheter assembly can have a valve, a valve opener, a fixing device, and a needle guard disposed inside the catheter hub. Optionally, the fixing device can be formed integrally with the valve. Optionally, the needle guard can be disposed outside the catheter hub, such as in a third hub separate from the catheter hub and the needle hub.

[0320] The side port can have a bore having an inlet opening. The bore of the side port can be in fluid communication with the internal cavity of the catheter hub and the lumen of the catheter tube. In an example, the bore of the side port can be in fluid communication with a distal internal chamber or internal cavity of the valve and the catheter lumen.

[0321] After successful venous puncture, after removing the needle and the needle hub from the catheter hub, one or more flaps of the valve can close, isolating the internal cavity from the distal distal chamber of the valve and the proximal proximal chamber of the valve. The side port can be isolated from the proximal chamber of the internal cavity by the valve. However, when the needle is disposed within the catheter tube and the needle deflects one or more of the valve flaps, fluid communication with the proximal chamber can occur.

[0322] A tube can be connected to the side port, and a fluid connector can be connected to the opposite end of the tube.

[0323] The vent plug, like other vent plugs described herein, can be connected to the proximal opening of the needle hub. An optional paddle grip can be incorporated into the needle hub, and the needle hub can be used with a catheter hub. When incorporated, the paddle grip can provide a grip closer to the puncture site during intravenous needle insertion. Generally, the closer to the puncture site, the more accurate the puncture can be. When incorporated, the paddle grip can be formed integrally with the needle hub.

[0324] The paddle grip can embody a nearly flat structure extending to the side of the needle hub and may have a distally extending length. The paddle grip may have a knob-like or curved outer contour with a rounded outer edge, or may have other shapes. Surface irregularities or gripping mechanisms may be incorporated into the paddle grip to facilitate gripping.

[0325] The paddle grip may be adjustable for left-handed or right-handed users by rotating the needle hub around the longitudinal axis of the needle. In some examples, the paddle grip may be formed by a clip ring, which can slide on the needle hub. The clip ring may be adjustable or rotatable around the needle hub so that the position of the paddle grip can be changed as desired by the practitioner. An exemplary adjustable paddle grip is disclosed in U.S. Patent Application Publication No. 2017 / 0173304(A1), the contents of which are expressly incorporated herein by reference.

[0326] The valve and valve opener can be located inside the catheter hub of the integrated catheter. The valve can embody the valve shown in Figure 13 and can be held between the distal and proximal shoulders. The valve can have two or more slits and two or more flaps, for example, three slits and three flaps or four slits and four flaps. The valve can have a valve disc of a constant or varying thickness.

[0327] A valve opener may be positioned near the valve and may include a nose section having an operating end for pushing into the valve to open one or more slits in the valve disc and deflect two or more flaps. The valve opener may include at least one plunger element, more preferably two spaced-apart plunger elements, and may have one or more gaps between them for fluid flow.

[0328] The stabilizing elements can be connected to or attached to the two plunger elements. The two stabilizing elements can be connected to the two plunger elements at their opposing side edges. The two stabilizing elements and the two plunger elements can form an inner opening that is smaller than the dimensions of the needle guard at the two elbows when biased by the needle, as described above. Therefore, when the needle biases the two arms of the needle guard apart, the needle guard is prevented from moving proximal to the two stabilizing elements due to the size difference.

[0329] In this example, the elbow of the needle guard is positioned distal to the two stabilizing elements and distal to the medial shoulder within the catheter hub. Thus, as previously mentioned, in addition to the two stabilizing elements, the needle guard can be held medially within the catheter hub by the proximal shoulder in the ready-to-use position and during needle retraction until the needle tip moves proximal to the two distal walls of the two arms.

[0330] The tube or length of the tube can be attached to a side port at the first end of the tube and a fluid connector at the second end of the tube. The fluid connector can embody a number of different devices, such as a plug bulkhead or a needleless valve. In an example, the fluid connector is a needleless valve comprising a housing with a movable piston located inside. The housing may have an inlet opening with a female luer for receiving a male luer tip, such as a syringe tip. The syringe can be used to open the fluid connector without a needle by compressing the piston.

[0331] When inserted into the inlet opening of the fluid connector, the male Luer tip of the syringe compresses the piston, opening the fluid path between the inlet and outlet of the housing. The outlet of the housing is connected to the tube. Thus, the fluid, such as a drug, supplement, or medication, dispensed from the syringe via the male Luer tip flows from the outlet of the housing into the tube through the needleless valve or fluid connector, then flows through the side port, then enters the distal chamber of the catheter hub, then enters the lumen of the catheter tube, and can enter the patient's body.

[0332] In use, a catheter assembly with a side port in an integrated catheter assembly, if present, can be grasped using a paddle grip and then inserted into a vein by the needle tip and the tip of the catheter tube. If a paddle grip is not available, the practitioner can grasp the needle hub, and possibly the catheter hub together. A primary blood flashback can be observed when blood flows through the needle into the needle hub. With a primary flashback confirmed, the practitioner can then pull the needle proximal to allow blood to flow between the needle and the catheter tube and check for a secondary blood flashback.

[0333] If a secondary blood flashback is observed, the user can further insert the catheter assembly into the vein by pushing the catheter tube further into the vein to access the blood vessel. The needle and needle hub can then be completely removed from the catheter tube and catheter hub. When the needle is retracted, the needle tip moves proximal to the two distal walls of the needle guard, which allows the two arms of the needle guard to move together and be released from the stabilizing element. Further needle retraction will remove the needle guard from the catheter hub when the shape-changing portion engages with the opening in the proximal wall of the needle guard. If the needle is pulled straight out of the catheter hub, the shape-changing portion may not engage with the opening in the proximal wall of the needle guard.

[0334] After the needle is removed from the integrated catheter, the valve's multiple valve flaps can rebound or return to their relaxed state, closing the slit and restricting proximal and distal flow through the valve. In the example, the operating end of the valve actuator or the nose section of the opener may be located proximal to the valve at the proximal position of the valve opener, spaced apart from the surface facing the proximal valve, and spaced apart from the retaining device if incorporated.

[0335] The tapered surface of the nose section is also spaced apart from the locking device if incorporated. This space or gap between the nose section and the locking device allows the valve actuating element to move distally forward when pushed by the male Luer tip before impacting or contacting the locking device if incorporated. This arrangement provides room for the valve opener to be displaced distally to open the valve. In some examples, as described elsewhere in this specification, the distal advance of the valve opener can be stopped when the male Luer tip abuts against the female Luer of the catheter hub at the Luer fit. The working end of the nose section can be spaced apart from the proximal surface of the valve in the ready-to-use position, with the needle tip extending distally to the distal opening of the catheter tube and in the proximal position of the valve opener. In other examples, the working end can contact the proximal surface of the valve before being advanced distally by the male Luer tip.

[0336] In this example, the IV infusion line of the IV administration set can be connected to the catheter hub of the integrated catheter via the proximal opening of the catheter hub. In the catheter hub occupied by the IV administration set, medication can be injected into the patient via a syringe or the like using a fluid connector connected to the catheter hub via a tube and side port. Alternatively, the IV infusion line of the IV administration set can be connected to the fluid connector, and medication can be injected via a syringe or the like using the proximal opening of the catheter hub.

[0337] A valve opener according to a further aspect of the present invention may include a transition section having a taper formed of several inclined segments. In other examples, the transition section may embody a smooth curve or a single inclined taper increasing proximal to the nose section. The nose section of the valve opener distal to the transition section may be substantially frustoconical in shape and have a through-opening for fluid flow. The tapered surface of the nose section may allow the valve flap of the valve to impart a pair of component forces that may be proximal to return the valve opener to its proximal position after the removal of the male lure tip.

[0338] In the example, two stabilizing elements are incorporated into the valve opener. Each stabilizing element can be connected to two plunger elements. Compared to the stabilizing elements in Figure 33, at least one of the stabilizing elements of the alternative valve opener may have a width formed between the distal and proximal edges, where the width may vary along the length of the bridge forming the stabilizing element. For example, the stabilizing element may have a width between the first and second ends, or between the two ends attached to the two plunger elements, and the width may be narrower near the two ends and wider near the middle of the length.

[0339] The wider portion of the stabilizing element may range from 25% to 75% of the length of the stabilizing element. However, as in the valve opener in Figure 33, one or both stabilizing elements may have the same width along their entire length, as well as the bridge forming the stabilizing element in Figure 33. In some examples, the wider portion may be located in the center between the two ends of the stabilizing element. In some examples, notches or recesses may be incorporated into the proximal edges of one or both stabilizing elements.

[0340] In the example, the distal edge of the wider portion of the stabilizing element may have a tapered edge. The taper of the tapered edge should begin on 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 tapered edge should be closer to the outer surface of the stabilizing element than to the inner surface of the stabilizing element. A configuration with a tapered edge can facilitate the removal of the needle guard. If two stabilizing elements are incorporated, the distal edges of both stabilizing elements may incorporate a tapered edge.

[0341] In some examples, each of the two stabilizing elements of a valve opener may have the same width along its length, and both stabilizing elements having a constant width may have tapered distal edges. For example, the distal edges of two stabilizing elements may have tapered edges. In some examples, a valve opener may have two stabilizing elements, one having the same width along its length and the other having a wider portion at a central position along its length. One or the other, or both, of the stabilizing elements may have tapered distal edges. In other examples, the distal edges of one or both of two different stabilizing elements may have typical square or straight upper and lower edges, which may also allow for the release of the needle guard.

[0342] The two plunger elements may have portions that extend proximal to the proximal edge of the stabilizing element. In some examples, the proximal edges of the two plunger elements and the proximal edge of the stabilizing element, or the proximal edges of both stabilizing elements, may terminate along substantially the same vertical plane. In embodiments where the proximal edges terminate along substantially the same plane, the distal edge of the stabilizing element may extend distally, for example, by increasing the width of the stabilizing element. The change in the position of the distal edge can be used to control the interaction between the needle guard and the stabilizing element.

[0343] A needle guard according to a further aspect of the present invention comprises a proximal wall having a periphery that houses a needle and forms an opening for engaging with a morphologically modified portion formed together with the needle. Two arms may extend distally from the proximal wall. Each arm may have a distal wall and an elbow located between the distal wall and an elongated portion of the arm.

[0344] Ribs or tabs can be incorporated into various parts of the needle guard to provide additional rigidity or stiffness. Tabs or ribs may be provided on the edges of the proximal wall, on each of the two elongated arm sections, and on the distal wall. In a preferred embodiment, each distal wall is provided with a curved lip such that the curved lip abuts against the side of the needle when the needle is positioned between the two arms. The curved lip can be incorporated with the needle guard so that the needle does not abut against the edges of the distal wall, which allows the needle to rub, although it may also have a flat outer surface instead of a curved lip. In some examples, tabs or ribs may be omitted from the distal wall, such as the curved lip on the first arm or the longer arm.

[0345] The two arms of the needle guard intersect each other along the side view shown in both the retracted or needle-exposed position and the needle-guarded or protective position. In other examples, the two arms may extend distally to the proximal wall on each side of the needle shaft but do not intersect the needle axis.

[0346] When the needle no longer biases the two arms of the needle guard, and the two arms can approach each other, the dimension measured between the two elbows decreases compared to the dimension at the two elbows when the two arms were biased by the needle. The needle can retract proximal until the change in shape abuts against the periphery that forms an opening in the proximal wall. The periphery of the proximal wall can have a dimension smaller than the maximum cross-sectional dimension of the change in shape. This allows the needle to move proximal and engage with the periphery to remove the needle guard together with the needle.

[0347] The two arms of the needle guard can have two different lengths. Therefore, in the protective position, the two distal walls can overlap when looking down at the needle axis. In this example, the angle between the distal wall and the elongated arm portion of the first arm can be greater than the angle between the distal wall and the elongated arm portion of the second arm.

[0348] In the example, each elongated arm portion of the two arms may be nearly straight or linear, and when biased by the needle, may bend or flex slightly to their respective elbows. A single radial bend is then provided to form each elbow and each distal wall. Another single radial bend may be provided to form each curved lip. At the elbows, the single radial bend may have a simple curve or a complex curve. However, unlike the needle guards in Figures 4 and 5, which have at least two bends and two directional changes between the elongated arm portions of the arms and the distal walls of each arm, this needle guard may have a single bend and a single directional change between the elongated arm portions and the distal walls of each arm.

[0349] A single bend and a single change of direction create a smooth or flat profile between the elongated arm portion and the elbow. The flat profile in the arm should be positioned to minimize or reduce interference with the edges of the valve opener's stabilizing elements, such as suspending or jamming. Therefore, additional bends or changes of direction may be present in each arm downstream of the first bend forming the elbow, provided that the transition between the elongated arm portion forming the elbow and the first bend is substantially flat or smooth to eliminate potential snags that could cause sticking or binding with respect to the typical angular range in which the needle is oriented during withdrawal. Generally, during use, the needle is withdrawn straight out of the catheter hub along the same axis. In extreme cases, the needle can be withdrawn at an angle until it contacts the upper proximal opening of the catheter hub. If the needle is withdrawn at an angle higher than simply contacting the proximal opening of the catheter hub, this is abusive use and can result in needle bending.

[0350] The arms of the needle guard may have a smooth or flat outer shape between the elongated arm portion and the elbow, and may have only a single bend or change of direction. As shown in the figure, each elongated arm section of the first and second arms may have sections with different arm widths. Each arm may also include a notch with a hook-like lip. The notches in the two arms allow the two arms to straddle the needle and provide lateral stability when the needle moves from a ready-to-use position with the needle tip exposed to a protected position with the needle tip protected.

[0351] Each of the needle guards described herein can be formed from a punched metal sheet, such as a punched stainless steel sheet, using punching and bending methods to create the needle guard in the shape shown.

[0352] After successful venipuncture, as the needle tip retracts proximally to the two distal walls of the needle guard, the bias of the two arms by the needle is removed, allowing the two arms to approach or even touch each other. This reduces the dimension measured by the two elbows, thus allowing the needle guard to move proximally through the opening formed by the two stabilizing elements and the two plunger elements. However, while retracting the needle and needle guard through the opening, the practitioner may inadvertently tilt the needle during proximal retraction. When this occurs, the needle guard may come into contact with the distal edges of one or both stabilizing elements during retraction, thereby capturing contact between the needle guard and the stabilizing elements, and in some cases, getting stuck. This, in turn, prevents the needle guard from being removed through the opening.

[0353] When the arm of a needle guard has two or more bends or changes of direction in the transition between the elongated arm portion and the elbow, it is known that multiple changes of direction can catch the distal edge of one of the stabilizing elements while the needle guard is being retracted through the opening during needle removal. This requires the user to readjust the angle of the needle with respect to the longitudinal axis of the catheter hub to a value less than the maximum angle A during needle retraction to avoid the needle guard getting caught and obstructing retraction. In contrast, when the needle guard is used with a valve opener having one or two stabilizing elements, a single bend or change of direction between the elongated arm portion and the elbow results in a smooth or flat shape that does not easily catch on the distal edges of one or both stabilizing elements during needle retraction.

[0354] Therefore, retraction through the opening can be facilitated by utilizing a needle guard having an arm with a single bend or change of direction to generate a smooth or flat outer shape that does not easily catch on the distal edge. Thus, the user can position the angle of the needle with respect to the longitudinal axis of the catheter hub to the maximum angle B during retraction to avoid catching and hindering retraction. This is visually shown in Figures 47 and 48 for the purposes of this discussion. In the case of two catheter assemblies of similar size but with different needle guards, angle B is greater than angle A because one has one bend or change of direction and the other has two or more bends or changes of direction.

[0355] If the stabilizing element that the needle guard abuts or contacts during proximal retraction incorporates a tapered edge, the likelihood of the transition between elbows with the elongated arm portion of the needle guard catching the tapered distal edge is reduced. Therefore, even if the needle guard has two or more bends in the elbow and the catheter assembly has a stabilizing element with a tapered edge, a user holding a catheter assembly of the same size can hold the needle at a larger angle A' than angle A. Similarly, if the needle guard has only one bend or one change of direction to produce a smooth or flat outer shape that does not easily catch on the distal edge, a user holding a catheter assembly of the same size can hold the needle at a larger angle B' than angle A. Generally speaking, the angle B' with respect to a needle guard with a single bend or change of direction and a valve opener with a stabilizing element with a tapered edge is greater than the angle A' with respect to a needle guard with two or more bends or changes of direction and a valve opener with a stabilizing element with a tapered edge.

[0356] Aspects of the present invention are further understood to include a catheter assembly comprising: a catheter tube having a lumen, a distal end opening, and a proximal end attached to a catheter hub, wherein the catheter hub comprises a catheter body having an outer surface and an inner surface forming an internal cavity having at least one shoulder; a needle having a needle tip at the distal end and a proximal end attached to a needle hub, the needle having a needle tip that protrudes through the catheter hub and catheter tube and protrudes distally to the distal end opening in a ready-to-use position; a valve having a valve body comprising at least one slit, a proximal surface, and a distal surface, and the internal cavity of the catheter hub A valve actuator positioned in a location having a nose section having a bore and a proximal section having at least one gap through which a fluid flow passes or across, and which is slidable between a proximal and distal position inside the internal cavity when pushed by a male lure; and a needle guard positioned on the side of the needle in a ready-to-use position and having a protective surface that is movable to a distal position of the needle tip in a protective position to cover the needle tip from accidental needle sticks, wherein the needle guard has an arm with an elbow between an elongated arm section and a distal wall, the elbow having a unidirectional variable portion at a position that can contact a stabilizing element of the valve actuator while the needle guard is retracted without capturing, obstructing, and / or stopping the movement of the needle.

[0357] The fixing device can contact or integrate with the valve at the proximal surface of the valve body in order to hold the valve inside the internal cavity of the catheter hub, and the fixing device may include a retainer body having an inner surface that forms a bore, a fluid path, a distal end, and a proximal end.

[0358] The catheter hub may have a side port attached to the tube at the first end of the tube. The fluid connector may be a connector to the second end of the tube. The fluid connector may be a needleless connector. The catheter assembly may be called an integrated catheter assembly.

[0359] The stabilizing element of a valve opener or actuator may have a distal edge. The distal edge may have a tapered edge. The taper of the tapered edge should begin on 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 tapered edge should be closer to the outer surface of the stabilizing element than to the inner surface of the stabilizing element.

[0360] The needle guard may have an arm with a single directional variation between an elongated arm portion and the distal wall of the arm, and the elbow between the elongated arm portion and the distal wall generates a smooth or flat outer shape that does not easily catch on the distal edge of the stabilizing element of the valve actuator.

[0361] Methods for manufacturing and using catheter assemblies and their components are within the scope of the present invention. [Brief explanation of the drawing]

[0362] These and other features and advantages of the apparatus, system, and method will be better understood as they are better understood by referring to this specification, the claims, and the accompanying drawings. [Figure 1] This is a schematic perspective view of a catheter assembly or needle device according to an aspect of the present invention. [Figure 2] This is a partial cross-sectional perspective view of the assembly shown in Figure 1. [Figure 3] Figure 1 is an exploded view of the needle device or catheter assembly. [Figure 4] This is an enlarged partial cross-sectional side view of the assembly shown in Figure 1. [Figure 5] This is a side view of the cross-section of the assembly shown in Figure 4, rotated 90 degrees. [Figure 6] Figures 1 to 5 are cross-sectional side views of the assembly in a state where the needle and needle hub have been removed after successful venipuncture, and the valve opener is in a proximal position. [Figure 7] Figure 6 is a cross-sectional side view of the assembly with the valve opener in the distal position and the valve open. [Figure 8] This is a cross-sectional side view of an embodiment of a catheter assembly or needle device, showing the needle and needle hub removed after successful venipuncture, with the valve opener in a proximal position. [Figure 9] Figure 8 is a cross-sectional side view of the assembly, with the valve opener in the distal position and the valve open. [Figure 10] This is a cross-sectional side view of another embodiment of a catheter assembly or needle device, showing the needle and needle hub removed after successful venipuncture, with the valve opener in a proximal position. [Figure 11] Figure 10 is a cross-sectional side view of the assembly with the valve opener in the distal position and the valve open. [Figure 12] The following diagrams show a cross-sectional side view, a front view, and a front perspective view of a fixing device according to an embodiment of the present invention. [Figure 13] The cross-sectional side view, front view, and front perspective view of a valve and fixing device according to an embodiment of the present invention are shown. [Figure 14] A cross-sectional side view, a front view, and a front perspective view of another fixing device according to an aspect of the present invention are shown. [Figure 15] Different diagrams of spring-shaped fastening devices are shown. [Figure 16] Figure 15 shows a cross-sectional side view of another embodiment of a catheter assembly or needle device with the fixing device removed, with the needle and needle hub removed. [Figure 17] Figure 16 is a cross-sectional side view of the assembly with the valve opener in the distal position and the valve open. [Figure 18] This is a cross-sectional side view of another embodiment of a catheter assembly or needle device, showing the needle and needle hub removed after successful venipuncture, with the valve opener in a proximal position. [Figure 19] Figure 18 is a cross-sectional side view of the assembly with the valve opener in the distal position and the valve open. [Figure 20] This is a cross-sectional side view of another embodiment of a catheter assembly or needle device, showing the needle and needle hub removed after successful venipuncture, with the valve opener in a proximal position. [Figure 21] Figure 20 is a cross-sectional side view of the assembly, with the valve opener in the distal position and the valve open. [Figure 22] A cross-sectional side view, a front view, and a front perspective view of another fixing device according to an aspect of the present invention are shown. [Figure 23] This is a cross-sectional side view of another embodiment of a catheter assembly or needle device, showing the needle and needle hub removed after successful venipuncture, with the valve opener in a proximal position. [Figure 24] Figure 23 is a cross-sectional side view of the assembly with the valve opener in the distal position and the valve open. [Figure 25] This is a perspective view of a fixing device that can implement an eyelet. [Figure 26] This is a perspective view of a fixing device that can embody an eyelet according to a further aspect of the present invention. [Figure 27] This is a cross-sectional side view of another embodiment of a catheter assembly or needle device, showing the needle and needle hub removed after successful venipuncture, with the valve opener in a proximal position. [Figure 28] Figure 27 is a cross-sectional side view of the assembly, with the valve opener in the distal position and the valve open. [Figure 29] This is a cross-sectional side view of another embodiment of a catheter assembly or needle device, showing the needle and needle hub removed after successful venipuncture, with the valve opener in a proximal position. [Figure 30] Figure 29 is a cross-sectional side view of the assembly, with the valve opener in the distal position and the valve open. [Figure 31]This is a cross-sectional side view of another embodiment of a catheter assembly or needle device, showing the needle and needle hub removed after successful venipuncture, with the valve opener in a proximal position. [Figure 32A] Figure 31 is a cross-sectional side view of the assembly, with the valve opener in the distal position and the valve open. [Figure 32B] This is the same figure as Figure 32A, but rotated 90 degrees. [Figure 33] This is a perspective view of a valve opener provided according to an aspect of the present invention. [Figure 34] This is a perspective view of a valve comprising a valve disc and a skirt section. [Figure 35] This is a perspective view of a valve comprising a valve disc and a skirt section provided according to a further aspect of the present invention. [Figure 36] This is a cross-sectional side view of another embodiment of a catheter assembly or needle device, showing the needle and needle hub removed after successful venipuncture, with the valve opener in a proximal position. [Figure 37] Figure 36 is a cross-sectional side view of the assembly, with the valve opener in the distal position and the valve open. [Figure 38a] This is a perspective view of a fixing device equipped with multiple leaf springs. [Figure 38b] This is a front view of a fixing device equipped with multiple leaf springs. [Figure 39] This is a cross-sectional view of an alternative catheter assembly provided according to a further aspect of the present invention, which may be equipped with a side port. [Figure 40] This is a cross-sectional view of an alternative catheter assembly provided according to a further aspect of the present invention, which may be equipped with a side port. [Figure 41] This is a cross-sectional view of an alternative catheter assembly provided according to a further aspect of the present invention, which may be equipped with a side port. [Figure 42] This is a perspective view of an integrated catheter assembly, including a side port connected to a tube further connected to a fluid connector. [Figure 43] This is a perspective view of a valve opener or actuator provided according to a further aspect of the present invention. [Figure 44] This is an enlarged cross-sectional view of a stabilizing element having a tapered distal edge. [Figure 45A] The diagram shows a needle guard attached to a needle, which has an arm having a single bend or a single direction of change. [Figure 45B] The diagram shows a needle guard attached to a needle, which has an arm having a single bend or a single direction of change. [Figure 46A] Different perspective views of the needle guard in the open position are shown, as if the needle (not shown for clarity) were opening its arms to reveal the features of the needle guard. [Figure 46B] Different perspective views of the needle guard in the open position are shown, as if the needle (not shown for clarity) were opening its arms to reveal the features of the needle guard. [Figure 47] This shows the needle withdrawn from the catheter hub. For simplicity, the catheter tube is not shown protruding from the distal end of the catheter hub. [Figure 48] This is a magnified view of a portion of Figure 47. [Modes for carrying out the invention]

[0363] This disclosure relates in general to needle devices, and more particularly to catheter assemblies having improved valve systems and related improved methods. The improvements include a number of individual components and combinations of components. For example, the improvements include a structure and function for securing a valve within a standard diameter size catheter hub, providing a proximal axial force to return a valve opener, also called a valve actuator, from a distal to a proximal position when a male Luer is detached from the catheter hub, incorporating one or more components within a single-body catheter hub that can restrict fluid flow, enabling operation that allows fluid flow, preventing needle damage, and combinations thereof. A single-body catheter hub is understood as a single-piece catheter hub having a catheter tube extending from the distal end of the hub and a proximal opening at the proximal end for receiving a male medical device such as a male Luer tip.

[0364] Figure 1 shows a catheter assembly 100, also called a needle device or sheath needle catheter assembly, which comprises a catheter hub 102 having a catheter tube 104, a needle hub 106 to which a needle 108 is attached, and a needle protruding through the lumen of the catheter hub 102 and catheter tube 104. A vent plug 112 is located at the proximal end of the needle hub 106, and more specifically, is attached to the proximal opening of the needle hub 106. The needle bevel of the needle tip 114 protrudes distal to the distal opening of the catheter tube 104 or distal to the catheter tube opening 116 in the ready-to-use position of Figure 1. The needle hub 106 is coupled to the catheter hub 102 at the proximal opening of the catheter hub, which may have a female threaded Luer or Luer slip. The catheter hub 102 may incorporate one or more surface features, such as a push tab and ribs for pushing the catheter tube 104 and sheath needle 108 into the patient's vein. The needle hub 106 may also incorporate surface features for a more secure grip when puncturing a vein and withdrawing the needle 108 from the catheter tube 104. Unless otherwise specified, various components may be fabricated from conventional materials using conventional techniques.

[0365] In the example, a pair of wings may be incorporated into the body 126 of the catheter hub 102, with each wing extending in opposite directions from the bottom of the catheter hub, lateral to the longitudinal axis of the catheter hub. The pair of wings may be used by the operator, for example with adhesive tape or adhesive bandage, to secure the catheter hub to the patient after successful venipuncture.

[0366] Figure 2 is a partial cross-sectional perspective view of the needle assembly 100 of Figure 1, with the catheter hub 102 exposed along its longitudinal direction to show a valve 120 and a valve opener 122 located inside the catheter hub 102 or inside the internal cavity 123. The valve and valve opener may be incorporated to control the flow of fluid through the catheter hub, for example, to control injection or aspiration through the catheter hub, as will be further described below. Also shown is a needle guard or tip protector 130 located inside the internal cavity 123, which may have a surface or wall to prevent accidental contact with the needle tip when the needle is removed from the catheter tube and catheter hub after successful venipuncture.

[0367] The needle guard or tip protector 130 may embody a structure having one or more components for preventing inadvertent contact with the needle tip. For example, the needle guard 130 may have a structure or wall that moves from the side of the needle shaft and a position proximal to the needle tip to a position distal to the needle tip to cover or block the needle tip from inadvertent contact. In an example, the needle guard 130 may be one of the types described in U.S. Patent No. 10,166,370, the details of which are expressly incorporated herein by reference. Exemplary embodiments of needle guards are described further below.

[0368] The catheter hub 102 has a body 126 having an outer surface and an inner surface that forms an internal cavity 123. One or more shoulders or lips 176a, 176b, 176c (Figure 4) can be incorporated into the interior 123 and can be used to position a valve opener 122, a valve 120, and / or a needle guard 130 in a ready-to-use position. The needle guard 130 can be positioned inside the catheter hub 102 by a nose section 132 of the needle hub 106 that protrudes into the proximal opening 136 of the catheter hub 102. As shown, the needle assembly or catheter assembly 100 of Figure 2 may have a catheter hub 102 having an interior 123 with a valve 120, a valve opener 122, and a needle guard 130 positioned therein in a ready-to-use position. In the example, the needle guard 130 is optional and can be omitted. In yet another example, the needle guard 130 may be positioned substantially outside the catheter hub. For example, the finger portion or part of the finger portion of the needle guard can be positioned inside the catheter hub, while the rest of the needle guard structure can be positioned outside the catheter hub.

[0369] Also shown positioned inside the interior 123 of the catheter hub 102 in Figure 2 is a device or structure 124 for fixing or holding the valve 120 inside the catheter hub 102, and is generally referred to as a fixing device, fixing ring, or element 124. The fixing device, ring, or element 124 may have structures that embody retainers, retaining rings, retaining skirts, O-rings, etc., of various possible cross-sections, such as circular, elliptical, square, rectangular, or inclined coil springs. The fixing device 124 may be formed separately from the valve 120, or may be part of the valve, such as being used with the valve, integrated with the valve, or formed integrally with the valve. Unless otherwise indicated in the context, the term fixing device 124 may mean any of the described structures and their equivalents. In the example, the fixing device 124 is positioned in line with the valve 120, the valve opener 122, and the needle guard 130. In certain cases, the fixation device 124 has a bore or opening for receiving the needle 108 and contacts both the valve and the inside of the catheter hub 102 to restrict the proximal movement of the valve 120 inside the interior 123, assist in returning the valve opener 122 from a distal position to a proximal position, or, as further described below, contacts for both purposes. The valve opener or a portion of the valve opener 122 can be positioned within the bore of the fixation device 124 in both the ready-to-use position of the catheter assembly and in the use position, such as after successful venipuncture, as further described below, as shown in Figure 1.

[0370] As shown in the figure, the needle guard 130 may comprise a metal body having spring or elastic properties, a proximal wall 140, and at least one or two arms (as shown) extending distally from the proximal wall 140. The change in shape 142 may be formed on the needle shaft proximal to and near the needle tip 114 and may engage with the periphery forming an opening in the proximal wall 140 to restrict distal movement of the needle guard away from the needle, but allowing the tip 114 to enter the needle guard 130. The change in shape 142 may include a crimp, a stack of material, a sleeve, or any other increase in diameter that is larger than the opening in the proximal wall 140.

[0371] Figure 2 shows that the valve 120, valve opener or valve actuator 122, fixing device 124, and needle guard 130 are configured such that they are sized and shaped to be housed inside 123 of the catheter hub 102, which may have a single, integral hub body, such as a single hub body formed from a single unit, having a proximal opening with a female Luer connector and a distal end having a catheter tube extending therefrom, and optionally having external threads or lugs (as shown). In other examples, the catheter hub 102 may be made from a hub body of multiple parts. For example, the catheter hub 102 may have a first hub body attached to a second hub body by adhesive or welding to form the body of the catheter hub 102.

[0372] Figure 3 is an exploded perspective view of the catheter assembly or needle device 100 of Figure 1, shown with an exemplary valve 120, an exemplary valve opener 122, and an exemplary fixing device 124. Also shown in Figure 3 are 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, can form the needle device 100 of Figures 1 and 2. A metal bush or fitting 146 is also shown, which is conventional and can be used to secure the proximal end of the catheter tube 104 inside the catheter hub 102. In other examples, the valve 120, valve opener 122, and / or fixing device 124 may be modified from the illustrated embodiments, such as having different specific structural features, as will be further described below. In some examples, the needle guard may be located outside the inside of the catheter hub, or substantially outside the catheter hub, with only the finger portion or tab partially extending inside the catheter hub.

[0373] In this example, the valve actuator 122 is provided with a nose section 150 at the distal end of the actuator body. The nose section 150 can be elongated, substantially cylindrical, or have a draft or taper terminating at an operating end 180 (Figure 7) for pushing into the valve 120 to open the valve slit, as will be further described below. The operating end of the nose section 150 may have a blunt distal end face or a sharp edge. A flow path may extend through the nose section 150 for the flow of fluid. The nose section 150 may have a wall surface with a continuous circumferential or continuous peripheral section forming a lumen or flow path. The wall of the nose section may be without gaps or slits, such as a cylinder with a continuous wall. The nose section 150 may form a bore. The bore may have a constant bore diameter or may vary by the taper of the nose section. In some examples, multiple spaced slits and / or openings can be provided in the nose section, such as through the walls of the nose section, to allow for the outflow of flow or fluid.

[0374] The two operating elements or plunger elements 152 can extend proximal to the nose section 150. For example, the two plunger elements 152 can be integrally formed with the nose section 150 and can extend proximal to the nose section. A gap or space that can form a retaining space can be provided between the two plunger elements 152. The needle guard or tip protector 130 can be positioned within the retaining space or between the two plunger elements 152. In this example, each of the two plunger elements 152 may include at least two longitudinal edges, which are spaced apart from each other. The longitudinal edges of the plunger elements 152 can be aligned with the longitudinal axis of the valve opener 122. A gap or space between the two plunger elements can function as a flow path for the fluid to pass through or across as the fluid passes through the catheter hub. In other examples, there may be two or more gaps or flow paths formed by the valve opener for the fluid flow. In further examples, two plunger elements can be connected to each other by two bridges, such that the proximal end of the valve opener is a continuous wall structure formed by parts of the two plunger elements and two bridges. In some examples, a single plunger element is used with the valve opener.

[0375] In this example, the projection 154 extends outward from the outer surface of one or both plunger elements 152. As shown in the figure, the projection 154 extends from the outer surface of each plunger element 152. Each projection 154 resembles a tab with a substantially flat edge for contacting a shoulder or lip formed inside the catheter hub 102. The tab surface and orientation of the projection 154 allow the valve actuator 122 to be inserted into the interior 123 of the catheter hub 102 and mounted within the catheter hub, as will be further described below. The projection 154 may be sized and shaped to contact or abut against the shoulder 176c inside the catheter hub in order to restrict the proximal movement of the valve opener or actuator 122.

[0376] In this example, the transition section extends from the nose section 150 and widens as the body of the valve opener extends axially in the proximal direction. The two actuating elements 152 may extend from the transition section, or they may extend from the nose section 150 without a transition section. In some embodiments, other shapes such as a rectangular, conical, pyramidal, or chamfered shape can be used for the nose section 150.

[0377] In the example, the valve actuator or valve opener 122 has a longitudinal axis, and one or more actuation elements 152 extend axially or parallel to the longitudinal axis. In certain examples, two actuation elements 152 are diametrically opposed to each other along the longitudinal axis. In other examples, two actuation elements may diverge from each other as they extend proximal. In yet another example, two actuation elements may converge towards each other as they extend proximal. The spacing between two plunger elements can be linear, converging, or diverging, forming a holding space between them. As shown, the two actuation elements 152 form an outer diameter that is larger than the diameter of the nose section 150. For example, the diameter formed by the two actuator elements 152 at the proximal end is larger than the diameter formed by any section of the nose section 150, excluding the projection 154. In some examples, the diameter formed by the two actuator elements 152 is only larger than the actuation end of the nose section. In some examples, the nose section of the valve actuator is provided with a molded contour having a separate line, etc., by forming a recess in the nose section having a separate contour line or curve. Then, as will be discussed further below, one or more surfaces of the contoured nose section can be used to press and repel the valve, thereby pressing the contoured nose section proximal and returning the valve actuator to its proximal position.

[0378] In one example, the actuator element 152 is flexible and deflectable, so that when pressed by a male Luer tip such as a syringe tip or a male Luer tip adapter, the actuator element 152 can be damaged or bent. The actuator element 152 may be deflectable by selecting a material having the required elastic properties. In another example, the actuator element 152 may be deflectable by incorporating one or more weakening compartments, for example, by incorporating a structurally thin compartment, by incorporating a notch, by using a smaller cross-section compared to other compartments of the same elongated actuator element, or by a combination thereof. Alternatively, the actuator element 152 may be flexible and deflectable by selecting a material having the required elastic properties and by incorporating one or more weakening compartments.

[0379] In yet another example, each actuation element 152 may have multiple different cross-sectional or external shapes along its length. For example, an elongated plunger element may have a square external shape adjacent to a crescent-shaped external shape.

[0380] In this example, the actuating element 152 is rigid and not deflectable or deformable when loaded, such as when pushed by the male lure tip. Furthermore, one or more stabilizing elements 158 can be incorporated to increase the rigidity of the two actuating elements 152. As will be further described below, each of the two actuator elements 152 may have a cross-sectional shape at least at its proximal end that overlaps the pushing end of the male tip, so that the male tip can push the valve actuator into the valve. The stabilizing element 158 ​​may be located distal to the proximal edge 182 (Figure 4) of the actuator element 152, or may have a proximal edge that is coplanar with the proximal edge of the actuator element.

[0381] The nose section 150 of the valve actuator 122 can be configured to engage with the valve 120 to open the valve flaps and the slit formed between them when an axial force is applied to the plunger element or actuator element 152 by the male tip, such as during insertion of the male Luer connector of an IV drip line or dosing set, causing the valve actuator 122 to move into the valve and deflect the valve flaps. Generally, the nose section 150 of the valve opener is rigid relative to the more flexible valve 120, so that the nose section 150, more specifically the working end 180 (Figure 7) of the nose section, can actuate the valve 120 to deflect, for example, one or more flaps and open one or more slits in the valve 120. The nose section 150 can be made of an incompressible material such as a metal material, rigid plastic, or hard elastomer to press and open the valve.

[0382] The illustrated valve actuator embodiment 122 includes a pair of opposing bands or stabilizers 158 that connect two actuating elements 152 at a position along the length of the actuating elements between the nose section 150 and the proximal ends of the actuating elements. In some examples, the stabilizers 158 can be positioned at the proximal ends of the two actuating elements 152 such that the proximal edges of the stabilizers 158 are substantially flush with the proximal end faces of the actuating elements 152. The two stabilizer elements or bands 158 can be referred to as the first or upper stabilizer element and the second or lower stabilizer element in the direction of elevation.

[0383] In one embodiment, the stabilizer or stabilizer element 158 ​​has an arc-shaped wall surface and forms an arc that substantially follows the internal shape of the catheter hub 102, connecting one actuation element 152 to the other actuation element 152. The stabilizer or stabilizer element 158 ​​can form a substantially continuous cylindrical portion on the body of the valve actuator, which is formed by two stabilizer elements and two actuation elements and is spaced apart from the nose section 150 of the valve actuator 122. In other words, the valve actuator 122 can be elongated and may have a radially continuous section and a section having a relief passage or through-passage through the wall of the actuator that is not radially continuous.

[0384] In the example, the stabilizer 158 forms a continuous body section around or radially along the valve actuator, spaced apart from the continuous body section of the nose section 150, which is also continuous around or radially. Two stabilizers or stabilizer elements 158, also called bands, can be joined together with two plunger elements 152 to form a ring structure. Optionally, the two stabilizers 158 may be slightly offset and angled from each other axially along the length of the valve actuator 122. In some embodiments, there may be one, three, or a different number of actuating elements 152 or stabilizers 158. For example, there may be two actuating elements 152 but only one stabilizer or band 158. In the example, the valve actuator 122 having the stabilizers or stabilizer elements 158 and projections 154 is fabricated from plastic, such as by plastic injection molding.

[0385] The stabilizer 158 can help keep the valve actuator 122 centered within the catheter hub 102 while the actuator 122 is moving, such as when it is pushed by the male Luer tip to open the valve slit. By staying centered, the nose section 150 can be better aligned with the valve disc 121 of the valve, such as the slit in the valve disc, enabling smooth operation of the valve 120. The stabilizer 158 can also provide engagement with the inside of the catheter hub 102 via friction to prevent the actuator 122 from sliding proximal after the removal of the male Luer tip. However, as described above, the projection 154 can be incorporated with the valve actuator 122 to hold the valve actuator 122 inside the catheter hub 102 in cooperation with the inner shoulder or lip 176c inside the catheter hub 102.

[0386] In one embodiment, the nose section 150 is configured to remain engaged with the valve disc 121 of the valve 120 after the valve has been actuated and the male lure tip has been removed. For example, the nose section 150 can be positioned between one or more slits in the valve disc, where it can be held in place by friction. To maintain engagement between the actuator 122 and the valve 120 after actuated and the male lure tip has been removed, the valve actuator 122, such as the nose section 150, can be provided with surface features such as grooves, ridges, or fins. Preferably, the valve actuator 122 does not engage with the valve 120 after the male lure tip has been removed. Preferably, the valve actuator can move from a distal position pressed against the valve to a proximal position that is separated from the valve or makes minimal contact with the valve, but allows the valve flap to return or close the slits. When the valve opener returns to the proximal position after the male lure tip has been removed, the valve can close to prevent or restrict the flow of fluid across the valve. The valve can be reopened by displacing the valve opener 122 distally with a male medical device such as the tip of a syringe or the tip of a dispensing set.

[0387] At least one relief passage, opening, or through-passage 160 is provided between the transition section of the valve actuator 122 and the proximal end of the valve actuator. The transition section can be understood as the section proximal to the operating distal end, or the section from the nose section to the two stabilizers. In this example, two relief passages or through-passages 160 are incorporated to provide clearance so that the interior or central portion of the valve actuator 122 can be in open communication with the inner surface of the catheter hub 102. In other words, between the continuous section of the nose section and the continuous peripheral section formed by the two stabilizers 158 and plunger element 152, there is a stabilizing ring 162, which has one or two relief passages, through-passages, or openings 160 for fluid flow such as flushing. The through-openings or relief passages can also be used to hold the needle guard, as will be further described below.

[0388] The stabilizing ring 162 of the valve actuator 122 may have an inner diameter smaller than the diameter formed by the diagonal section or elbow of the two arms of the needle guard 130 when the two arms are biased outward by the sides of the needle shaft in the ready-to-use position. Thus, while the needle guard 130 is installed in the retaining space of the valve actuator, the diagonal section or elbow of the needle guard 130 can deflect through the stabilizing ring 158 and enter the opening area formed by the relief passage or through-opening 160.

[0389] When the tip protector 130 is positioned between the two plunger elements 152, the two distal walls of the needle guard 130, more specifically the two diagonal compartments or elbows of the needle guard, are positioned within the relief passage 160 as described above and can engage with the guard engagement surface on the inner surface of the catheter hub. This allows the needle guard 130 to protrude from the holding space of the valve actuator 122 through the two relief passages 160 and engage with the guard engagement surface of the catheter hub. Thus, the needle guard can be held inside the catheter hub in the ready-to-use position and during needle retraction after successful venous puncture until the tip of the needle moves proximal to the two distal walls of the needle guard, at which point the needle guard can close the tip of the sheath needle, and the distal end of the needle guard 130 becomes smaller in diameter than the inner diameter of the valve opener at the stabilizing ring 162 and can be removed together with the needle.

[0390] Undercuts or recessed compartments can be provided in the internal cavity of the catheter hub 102 to accommodate the two diagonal compartments or elbows of the needle guard. Thus, the needle guard 130 can be prevented from sliding proximal during needle retraction after successful venipuncture by the shoulders of the recessed compartments or by any other surface feature inside the catheter hub, such as guard engagement surfaces inside the catheter hub. Optionally or alternatively, the distal edges of one or both stabilizers 158 can be provided with restraining surfaces to prevent the needle guard 130 from acting prematurely during needle retraction before the needle tip moves proximal to the two distal walls of the needle guard. In addition to the distal edges, each stabilizer 158 may have a proximal edge. When the needle guard 130 is held by one or both distal edges of the stabilizers 158, the inner surface of the catheter hub 102 can omit engagement mechanisms or multiple mechanisms for accommodating the elbows of the needle guard. In this example, the needle guard 130 can engage with the distal edges of one or both of the two stabilizers 158, and can engage with engaging features formed on the inside of the catheter hub, such as grooves, lips, or shoulders.

[0391] In some examples, one or both stabilizer elements 158 may have slits or channels, thus dividing the arc-shaped stabilizing or stabilizer element into two segments. Even if one or both stabilizer elements 158 have slits, the stabilizing ring 162, which may be a discontinuous ring as well as a ring having one or more slots formed through the ring, can still interact with the two elbows to provide a retaining structure to prevent the needle guard 130 from acting prematurely during needle retraction before the needle tip moves proximal to the two distal walls.

[0392] The retaining surfaces of stabilizer elements, such as the distal edge, can be called limiting points, choke gaps, or choke points, because they provide a rigid structure that prevents the needle guard from moving proximal to the choke point unless the needle guard first acts radially and collapses, reducing its radial profile and then slips proximal to the choke point. In the example, the choke points can restrict the proximal movement of one or two elbows of the needle guard until one or two elbows of the needle guard are deflected, reducing the radial profile of the needle guard. In the example, once the radial profile of the needle guard is reduced, the needle guard can slip through the bore formed by the stabilizing ring 162 from the distal position of the stabilizing ring to the proximal position of the stabilizing ring.

[0393] The valve opener 122 can be made from a metal or plastic material. If made from a metal material, the valve opener 122 can be formed by bending or deep drawing, and the arc-shaped cross section of the actuation element 152 can provide additional rigidity when pressed by a male luer. Each actuation element 152 may include at least two longitudinal edges, and ribs may be provided along one or both of the longitudinal edges to further add structural rigidity. One or more gaps may be provided between any two actuation elements 152. The gaps can provide space for fluid flow through the gap or space, such as during blood washing or IV infusion. The gaps between the actuation elements 152 can form a retaining space for housing the tip protector 122.

[0394] In some embodiments, as will be further described below, most, if not all, of the tip protector 130 is fitted into a retaining space formed by the body of the actuator 122 between the two plunger elements 152 in the ready-to-use position. This allows the catheter hub 102 to be made more compact, as less longitudinal space is required within the hub when both the valve actuator 122 and the tip protector 130 are fitted in series longitudinally, or when the two overlap only partially in the axial direction.

[0395] If the tip protector 130 engages only with the distal edge of the relief passage or through-passage 160 within the actuator 122, no deformation or change in diameter is required on the inner wall of the catheter hub, and the tip protector 130 can be positioned even more proximal within the female Luer taper compartment while conforming to the international Luer standard for conical joints, thereby further shortening the overall length of the catheter hub 102.

[0396] An exemplary valve 120 shown in aspects of this disclosure can be used with catheter assemblies and hubs having female Luer connectors as described herein. Referring to Figure 3 and further to Figure 4, Figure 4 shows the catheter assembly or needle assembly 100 of Figures 1 to 3, and along a longitudinal cross-section, the valve 120 may have a first portion 168 having a first thickness and a second portion 170 having a second thickness that is thinner than the first thickness, measured perpendicular to an intermediate plane passing through the diameter of the valve. The second portion 170 having a second thickness may have a substantially constant thickness, but optionally, the second portion may include a thickness that varies along the cross-section of the valve.

[0397] In the example, the second portion 170 is formed by recessing the distal surface of the valve, the proximal surface of the valve, or both surfaces, while the first portion 168 substantially holds the full width or thickness of the valve between the proximal and distal surfaces. In the example, the recess of the second portion 170 can embody an undercut formed in the valve. As shown in Figure 3, the surface appearance between the first portion and the second portions 168, 170 may resemble a three-leaf clover. The three-leaf clover can be present on the distal surface, the proximal surface, or both surfaces of the valve 120. In other examples, the appearance of the proximal surface and / or distal surface can have various contours, so that the three-leaf clover can have various curves, lines, and edge contours. In the example, a slit is formed through the thinner second portion 170 of the valve to form a valve flap between adjacent valve slits. In some examples, there may be two or more slits forming one or more valve flaps. For example, the first and second portions 168, 170 of the valve 120 can form a four-leaf clover, which may have four slits and four valve flaps. Preferably, the valve may have three slits and three valve flaps. The slits start approximately in the center of the valve and extend radially outward toward the outer circumference of the valve, but may extend to just before the outer circumference of the valve. The length of each slit may vary to form valve flaps of different sizes. The length of the slits may be selected to provide desired valve flaps and valve flap deflection when pressed by the nose section 150 of the valve opener 122, such as when pressed by the operating distal end of the valve opener 122.

[0398] The valve 120 may be formed integrally from a single material. Alternatively, the valve 120 may be formed from different materials in different parts 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 the valve 120 can be made in accordance with the examples of valves disclosed in PCT application number PCT / EP2017 / 070934, published as PCT Publication WO2018 / 033626(A1). Its contents are expressly incorporated herein by reference as if they were fully described.

[0399] In this embodiment, the fixing device 124 is a retaining ring having an annular wall structure with an outer surface and an inner surface forming a bore. In other embodiments, the fixing device for fixing the valve inside the catheter hub may be a retaining skirt, an O-ring, or a spring. The valve 120, the valve opener or valve actuator 122, and the fixing device 124 can be modified in shape, style, and features, but can otherwise perform the functions described herein. The valve 120 may be the valve disc described above having at least one slit that forms at least two flaps. As shown, the valve disc may have three or more slits (as shown) that form three or more flaps, and the surface of the disc may have surface features and thickness that vary along the cross-section of the valve disc. In other examples, the valve may have a valve disc and a skirt extending proximal to the proximal surface of the valve disc.

[0400] Figure 4 shows a partial cross-sectional view of a catheter assembly or needle device 100 that can embody the assembled catheter assembly of Figure 3. The catheter assembly 100 is shown without the needle 108, the catheter tube 104, and part of the needle hub 106, and without the vent plug, which is usually located at the proximal opening of the needle hub. The catheter hub 102 is shown to have a valve 120, a valve opener 122, a fixation device 124, and a needle guard 130, which are located inside the internal cavity 123 of the hub body 126, and may be a single hub body having a distal end with a catheter tube extending therefrom and a proximal opening with a female Luer connector. As shown, the valve 120 is located distal to the fixation device 124, part of the valve opener 122 is located within the bore of the fixation device 124, and the needle guard 130 is located within the retaining space 174 of the valve opener 122.

[0401] In this example, the inside of the catheter hub 102 is provided with one or more shoulders or ledges 176a, 176b, 176c, which can be understood as structural lips or stoppers formed on the inner wall. One or more shoulders, generally referred to as shoulders 176, can provide engagement points or stopping points for components located inside the internal cavity 123 to prevent the components from moving out of or falling out of the inside of the catheter hub. As shown, the valve 120 can be positioned in the annular groove and can abut against one of the shoulders 176a to prevent proximal displacement of the valve 120. As shown, the valve 120 also abuts against the shoulder 173 (Figure 5) of the catheter hub 102 at the distal side of the valve to prevent distal displacement of the outer circumference of the valve.

[0402] An annular ring-shaped fixation device or retaining ring 124 is positioned adjacent to the valve 120 and, at its proximal end, abuts against another shoulder portion 176b within the internal cavity 123 of the catheter hub to prevent proximal displacement of the fixation device 124. As shown, the fixation device 124 has a cross-section with a beveled, triangular, or inclined surface, where the higher part of the bevel is distal and tapers towards the proximal direction. The fixation device 124 may be fabricated from a medical-grade plastic material by plastic injection or the like. In other examples, the fixation device may be fabricated from a metal material by punching, then forging, pressing, or machining or the like. In other examples, the fixation device 124 may be fabricated from an elastomer material such as an O-ring to provide a proximal force to the valve opener when compressed, deformed, or biased between the nose section 150 of the valve opener and the inner wall of the catheter hub distally.

[0403] The distal end of the fixing device 124, the higher portion of the bevel, abuts against the proximal surface of the valve 120, and the proximal end of the fixing device 124, the narrower portion of the bevel, abuts against one of the shoulders 176b of the internal cavity 123. This arrangement of the fixing device 124 can help hold the valve 120 from proximal displacement within the catheter hub. In some examples, the valve 124 can be fixed or supported within the catheter hub by the fixing device without relying on a separate shoulder 176 abutting against the proximal edge of the valve. In examples, the fixing device 124 may have slight interference when first entering the proximal opening end of the catheter hub and may have a sizing fit or slight interference fit with the catheter hub at the final mounting position shown. In yet another example, the fixing device 124 can be held within the catheter hub, and the valve 120 can be fixed from proximal displacement by interference fit with the catheter hub alone, without a separate shoulder abutting against the proximal end of the fixing device.

[0404] The fixing device can be a retaining ring 124 having a substantially triangular cross-section as shown in the figure. In other examples, the cross-section may have a different shape. As will be further described below, the retaining ring 124 or the fixing device can also function as a return mechanism to help the valve opener 122 return or move from a distal position to a proximal position. For example, when the valve opener 122 advances by the male Luer tip to open the slit of the valve 120, the retaining ring 124 can help return the valve opener to the proximal position after the male Luer tip has been removed from the proximal opening of the catheter hub. In some examples, the fixing device 124 simply fixes the valve from proximal movement while the elasticity of the valve returns the valve opener from a distal position to a proximal position. In some examples, the cross-section of the fixing device can be selected to have a shape other than a triangle. In other examples, the molded cross-section of the retaining ring 124 can be formed as a retaining skirt and become part of the valve. For example, the valve 120 can be formed as both a valve disc and a retaining skirt, for example, by being integrated or integrally formed.

[0405] In the illustrated example, the length of the valve opener 122 is selected such that the working end 180 at the distal end of the nose section 150 is just in contact with the valve disc of the valve, and the proximal end edges 182 of the two plunger elements 152 are just in contact with the nose section 184 of the needle hub 106. In other examples, the working end 180 may be slightly separated from the valve disc or slightly pressed against the valve disc, but not substantially deflecting the valve flap to allow the valve flap to close the valve slit. Note that the valve flap of the valve will deflect slightly distally due to the presence of the needle.

[0406] In this example, the retaining space 174 of the valve opener 122 is sized and shaped to accommodate the needle guard 130. Referring to both Figures 4 and 5, Figure 5 shows the needle device 100 of Figure 4 rotated 90 degrees, with the needle guard 130 positioned between the two plunger elements 152 of the valve opener 122. The needle guard 130, having a proximal wall 140 and two arms 188, 190 positioned distal to the proximal wall 140, is positioned within the retaining space 174 of the valve opener 122, with the two elbows 188a, 190a of the needle guard 130 positioned distal to the two stabilizing elements 158. The elbows are located between the distal walls 188b, 190b and the elongated arm portions of the arms. As the needle 108 retracts proximal, the two elbows 188a, 190a are stopped from moving proximal beyond the two distal edges 158a, 158a of the two stabilizing elements 158, which act as choke points. As previously mentioned, the radial dimension of the needle guard at the two elbows 188a, 190a is greater than the inner dimension of the stabilizing ring 162, and is therefore physically stopped by the distal edges of the two stabilizer elements 158. After successful venipuncture, the needle is removed from the catheter tube, and the catheter hub and needle tip move proximal to the two distal walls 188b, 190b of the needle guard, which allows the two arms 188, 190 of the needle guard to move inward or fold, reducing the radial dimension at the two elbows. Almost simultaneously, the portion 142 (Figure 2) with a change in outer shape near the tip of the needle comes into contact with the periphery forming the opening 192 in the proximal wall 140 of the needle guard, and as the needle is pulled further back, the needle guard 130 is removed together with the needle 108.

[0407] In this example, the interior of the catheter hub 102 is enlarged in the vicinity of the two elbows 188a and 190a. For example, the inner diameter of the catheter hub at the two elbows is larger than the inner diameter of the catheter hub at the proximal wall 140 of the catheter hub. This space can be incorporated to provide a relief passage or additional space for a needle guard in the standby position. That is, when the relief passage is incorporated, it provides space for the two arms 188 and 190 so that they are not compressed or biased inward to the same extent at the two elbows 188a and 190a in the ready-to-use position compared to when the relief passage is not provided. This reduces the resistance between the needle shaft and the two curved ends of the ends of the two tip walls 188b and 190b when the needle retracts after needle puncture.

[0408] Referring again to Figure 4, the valve opener 122 is held within the internal cavity 123 of the catheter hub 102, and its displacement from the proximal opening 136 can be limited by providing the valve opener with at least one lateral projection 154 to interact with one of the shoulder portions 176 within the internal cavity 123. The cross-sectional dimensions of the valve opener at at least one projection 154 are larger than the cross-sectional dimensions at the shoulder portion of the catheter hub 102, thereby providing a physical stop to prevent proximal displacement of the valve opener 122 from the proximal opening 136 of the catheter hub. As shown, if the valve opener 122 moves proximal, for example, when the needle is retracting but before the needle tip moves proximal to the two distal walls, the projection 154 can limit the overall proximal movement by striking the shoulder portion 176c. In this example, each actuating element 158 ​​can be provided with one projection 154, and the valve opener 122 can be provided with two projections 154, so as to interact with the shoulder portion 176c, which can be in an annular configuration.

[0409] Figure 6 is a cross-sectional side view of the needle assembly 100 of Figures 4 and 5, showing the needle 108, needle guard 130, and needle hub 106 removed from the catheter tube 104 and catheter hub 102 after successful venous puncture and placement of the catheter tube 104 in the patient's vein. As shown in the figure, the needle guard 130 is removed together with the needle 108 in the manner described above. After the removal of the needle 108, the multiple valve flaps 194 can return to a rebound or relaxed state, closing the slit 196 and restricting proximal and distal flow through the valve 120. In the illustrated state, the operating end 180 of the nose section 150 of the valve actuator 122 is located within the bore formed by the fixing device 124, but is either spaced apart from or not in contact with the fixing device 124. The tapered surface of the nose section 150 is also spaced apart from the fixing device 124. This space or gap allows the valve actuation element 122 to move distally forward when pushed by the male Luer tip before it collides with or contacts the fixing device 124. In some examples, the male Luer tip abuts against the female Luer of the catheter hub, stopping further distal advance of the male Luer tip into the catheter hub before the nose section 150 of the valve actuator contacts or presses against the inside of the fixing device 124. The actuation end 180 is shown in contact with the proximal surface of the valve 120. In other examples, the actuation end 180 can be spaced away from the proximal surface of the valve 120. The actuation end 180 can be spaced away from the valve by approximately the same distance as the gap between the projection 154 on the valve opener 122 and the inner shoulder of the catheter hub 102.

[0410] As shown in the figure, the nose section 150 of the valve opener 102 has a proximal increasing taper that is spaced apart from the tapered surface of the bevel section 198 of the fixation device 124. The size and shape of the nose section 150 can be arranged to contact the bevel section 198 of the fixation device 124 or to be spaced apart from the bevel section. In the example, the nose section 150 may incorporate an elastic band, strip, or other elastic section or band such as a strip, which can generate slight interference when the valve opener 122 advances distally to open the valve 120 and the nose section contacts the fixation device, as will be further described below with reference to Figure 7. If the longitudinal axis of the catheter hub 102 is considered to be the X-axis and the Y-axis is perpendicular to the X-axis, the shape of the nose section 150 is selected to deflect the valve flap 194 distally and generate a force vector having both X and Y components. A force vector acting in the X direction, a force vector with an X component, or a proximal force vector can be used to facilitate the return of the valve opener 102 from a distal position where the working end 180 is pushed into the valve 120 and deflects the valve flap 194 to the proximal position as shown. As will be discussed further below, the valve flap of the valve 120, or both the valve flap and the locking device 124 of the valve, can generate a force vector on the nose section 150 of the valve opener 122, thereby returning the valve opener from the distal to the proximal position. In yet another example, other parts of the valve other than the valve flap can apply a proximal force to move the valve from the distal to the proximal position.

[0411] In the example, the region or compartment within the catheter hub 102 adjacent to the proximal opening end 136 is understood to be a female Luer 204, which has a structure formed according to the ISO standard for female Luers. The two plunger elements 152 of the valve opener 122, the proximal edges 182 of 152 are recessed from the proximal opening end 136 of the catheter hub 102, but are located within the female Luer 204. Thus, when the male Luer tip is inserted into the female Luer, the male Luer tip pushes the two plunger elements 152 distally, pushing the valve opener 122 into the valve 120 and opening the valve.

[0412] Figure 7 is a cross-sectional side view of the assembly of Figure 6, which has a male Luer tip 200 inserted into the proximal end 136 of the opening, which advances the valve opener 122 into the valve 120 to open the valve flap 194 and open fluid communication between the male Luer tip 200 and the lumen of the catheter tube 104. In practice, the male Luer tip 200 may be the tip or male end of an IV infusion line or administration set attached to an IV bag. In the configuration of Figure 7, fluid can be drawn out or aspirated from the catheter hub 102 in the proximal direction, or injected through the catheter tube in the distal direction. Although not shown, the male Luer tip 200 may have a threaded collar for engaging with a lug or male thread 202 in the catheter hub 102 in order to further maintain the valve actuator 122 in the distal position and open the valve 120.

[0413] In the example, the valve opener 122 is configured to move distally as it is advanced by the male Luer tip 200. The amount or distance by which the valve opener 122 moves distally should be sufficient for the working end 180 and the nose section 150 to deflect the valve flap 194 distally, opening the slit of the valve 120 and opening fluid communication between the male Luer tip 200 and the catheter tube 104. In the illustrated example, the working end 180 of the valve opener 122 moves distal to the valve flap, and the valve flap is compressed between the inside of the catheter hub 102 and the tapered surface of the nose section 150, or the valve flap is deflected or deformed distally by the nose section of the valve opener, with or without compression. In other examples, the working end 180 moves equal to the end of the valve flap 194, or only a distance just before the end of the valve flap, still opening the valve flap and allowing free flow in both the proximal and distal directions.

[0414] When the male lure tip 200 is withdrawn, such as when replacing the IV fluid bag attached to the male lure tip 200, the distal force acting on the proximal edges 182 of the two plunger elements 152 by the male lure tip 200 is removed or stopped, and the female lure 204 is not occupied by any external object. As a result, the valve opener 122 can return to its proximal position and is now withdrawn by the male lure tip. In this example, the elasticity of the valve 120 allows the valve flap 194 to return to a more relaxed state, such as moving to the position shown in Figure 6. This repulsive action of the valve flap 194 and the shape of the nose section 150 of the valve opener 122 allow the valve flap to impart a force vector to the nose section 150 so that it moves the valve opener 122 from the distal position shown in Figure 7, as shown in Figure 6. The force vector generated by each of the valve flaps 194 in the nose section 150 of the valve opener 122 when the valve flap rebounds includes a force component substantially parallel to the longitudinal axis of the catheter hub, and is referred herein to as the X-component force vector or proximal force vector. Thus, the X-component force vector generated by the valve flap can move the valve opener 122 from a distal position where the operating end 180 and the nose section 150 deflect the valve flap distally to open the valve, to a proximal position where the operating end and the nose section no longer deflect the valve flap. In some examples, the nose section 150 of the valve actuator 122 is provided with a molded contour having a separate line or curve, etc., by forming a recess in the nose section having a separate contour line or curve. The valve 120 can then be pressed using one or more surfaces of the contoured nose section. The valve can be pressed to generate multiple compression points or biasing points. For example, a contoured nose section can compress the valve flap, or a valve opener can be structured to deflect the valve flap distally, so that the valve flap can generate a force vector relative to the nose section when the male lure tip is removed and the valve flap can return to their relaxed state.The contoured nose section can also compress, deform, or bias some or more parts of the valve axially relative to the distal shoulder, and as a result, the valve imparts an opposite axial return force when the male lure tip is removed, as will be further described below with reference to Figures 31 to 32B. Thus, when the valve is compressed, deformed, biased, or deflected and recoiled by the contoured nose section alone or by multiple point sections of the contoured nose section, the valve alone can push the valve opener proximal when the male lure tip is removed.

[0415] In some examples, interference between the inclined cross section 198 of the fixing device 124 and the nose section 150 generates a force vector in the nose section 150 of the valve opener 122 that includes a force vector with an X component. For example, the valve opener may incorporate an elastic band or one or more elastic strips that are compressed or biased by the fixing device as the nose section advances into the fixing device by the male lure tip. Thus, in addition to the return force generated by the valve flap of the valve 120 in the nose section 150 of the valve opener 122, the interference between the fixing device 124 and the nose section 150 of the valve opener generates a return force that contributes to the proximal movement of the valve opener 122 from a distal position where the working end and nose section deflect the valve flap distally to a proximal position where the working end and nose section no longer deflect the valve flap. In the proximal position, the valve opener 122 is located inside the catheter hub in the manner generally shown by Figure 6, which shows a valve flap that generally closes the slit to stop or restrict the fluid flow in the proximal and / or distal directions. In some examples, a recess can be provided in the nose compartment, and an elastic strip or band is placed in the recess to form a valve opener having a rigid compartment and a more flexible compartment. In other examples, the nose compartment is co-molded or insert-molded with the elastomer strip or band. The elastic strip or band incorporated into the nose compartment can allow the valve actuator to be pressed against a rigid part or component of the fixing device to generate a return force after the removal of the male luer tip.

[0416] Accordingly, aspects of the present invention are understood to include a catheter assembly or needle device comprising a catheter hub having a catheter tube extending distally, wherein the catheter hub comprises a body having an outer surface and an inner surface forming an internal cavity. A valve and valve opener may be located inside the internal cavity. In an example, a fixing device having a body forming a bore is located proximal to the valve. The valve flap of the valve can provide a proximal return force to return the valve opener from a distal to a proximal position. Additionally or alternatively, the valve can be axially compressed or biased with respect to the distal shoulder, and the valve provides an axially directed force with respect to the nose section to return the valve opener when the male luer tip is removed. In one example, the fixation device can provide interference with the valve opener, such as the elastomer portion of the valve opener, when the valve opener advances distally by the male Luer tip to open the valve flap of the valve. This interference can provide a force vector, including a force vector extending substantially parallel to the longitudinal axis of the catheter hub, to return the valve opener from the distal to the proximal position when the male Luer tip is removed from the catheter hub. In another example, the nose section is separated from or not in contact with the fixation device, and the return force is provided solely by the valve. The fixation device can further provide a fixation function to secure the valve within the catheter hub and prevent it from being inadvertently displaced proximal to the catheter hub. The catheter hub may include the catheter hub, valve, valve opener, fixation device, and a needle protruding through the catheter tube. The needle can be attached to the needle hub at its proximal end.

[0417] The valve opener can move distal to the valve to open two or more valve flaps when pressed by the tip of the male lure, and can return to its proximal position when the tip of the male lure is removed to allow the valve flaps to relax or close until closure in the slit, so that the valve can undergo multiple operating cycles. In this example, the valve can undergo two or more operating cycles. For example, the valve can undergo at least three cycles, at least four cycles, at least five cycles, or more. Each operating cycle may consist of movement of the valve opener toward the valve to deflect the valve flaps, and movement toward the valve.

[0418] Referring hereto to Figures 8 and 9, a catheter assembly or needle assembly 100 provided according to a further aspect of the present invention is shown, with the needle and needle hub removed, but it may have the same needle and needle hub as described elsewhere in this specification. The needle assembly 100 may also incorporate a needle guard as described elsewhere in this specification.

[0419] In this embodiment, the catheter hub 102, catheter tube 104, valve 120, valve opener 122, and fixation device 124 may be similar to those shown with reference to Figures 6 and 7, with some exceptions. In this embodiment, an annular slit or annular channel 206 is provided on the proximal surface of the valve 120. As shown, the annular slit 206 is recessed from the outer circumference of the valve. The annular slit 206 may be provided in the first portion 168 of the valve (Figure 3), which is a thicker portion of the valve than the second portion 170 of the valve. As will be further described below, the annular slit 206 may be provided to receive the distal end of the fixation device 124.

[0420] In this embodiment, the fixation device 124 is a retaining ring having a distal end 210 that protrudes into the annular slit 206. In this example, the distal end 210 of the fixation device 124 is pushed into the annular slit 206 and held therein by compression or interference. In other examples, the fixation device can be held in the annular slit 206 using adhesive or bonding. In yet another example, the annular slit 206 is an annular channel and does not grip the fixation device on both its inner and outer surfaces. For example, the outer surface of the fixation device 124 can press against the annular channel, but the inner surface of the fixation device is spaced away from the annular channel. This alternative configuration allows the fixation device 124 to push the valve 120 outward relative to the catheter hub without requiring an annular slit to grip both the inner and outer surfaces of the distal end of the fixation device.

[0421] The retaining ring 124 in this embodiment has a length between its proximal and distal ends and may have a wall at its proximal end having a curved body portion with substantially constant wall thickness. The wall has an interior that forms a bore for housing the nose section 150 of the valve opener 122. The wall of the fixing device 124 may be substantially cylindrical except at the proximal end. In this example, the proximal end 212 of the retaining ring 124 may have an outwardly curved lip 214 for fixing the retaining ring 124 against the inner shoulder 176b of the catheter hub 102. When positioned against the inner shoulder 176b, the fixing device 124 can help fix the valve 120 so that it does not displace proximal. The valve 120 is fixed or supported from distal movement by being positioned against the shoulder 173 (Figure 5) of the catheter hub 102 on the distal surface of the valve.

[0422] The fixing device 124 and the nose section 150 of the valve opener 122 are spaced apart from each other at the proximal position of the valve opener in Figure 8. The gap or space between the two provides an air gap for the valve opener 122 to move distally to open the valve and deflect, for example, the valve flap, before contacting or striking the fixing device 124. In the illustrated configuration, the operating end 180 of the nose section 150 of the valve actuator 122 is located within the bore formed by the fixing device 124, but is spaced apart from or not in contact with the fixing device. The tapered surface of the nose section is also spaced apart from the fixing device. This space or gap allows the valve operating element to move distally forward before impacting or contacting the fixing device. The operating end 180 is shown in contact with the proximal surface of the valve 120. In other examples, the operating end may be slightly spaced apart from the proximal surface of the valve.

[0423] Figure 9 is a cross-sectional side view of the assembly of Figure 8, similar to the embodiment in Figure 7, which has a male Luer tip 200 that is inserted into the proximal end 136 of the opening and advances the valve opener 122 into the valve 120 to open the valve flap 194 and open fluid communication between the male Luer tip 200 and the lumen of the catheter tube 104. Although not shown, the male Luer tip 200 may have a threaded collar for engaging with a lug or male thread 202 in the catheter hub 102 in order to further maintain the valve actuator 122 in a distal position and open the valve 120.

[0424] In the example, the valve opener 122 is configured to move distally as it is advanced by the male Luer tip 200. The amount or distance the valve opener moves distally should be sufficient for the working end 180 and nose section 150 to deflect the valve flap 194 distally, opening the slit and opening fluid communication between the male Luer tip 200 and the catheter tube 104. In the illustrated example, the working end 180 of the valve opener 122 moves distal to the valve flap, and the valve flap is compressed between the inside of the catheter hub 102 and the tapered surface of the nose section 150, or the valve flap is deflected or deformed distally by the nose section of the valve opener, with or without compression. As shown in the illustration, the working end 180 moves equal to or just short of the end of the valve flap 194, but far enough to open the valve sufficiently for free flow in both directions.

[0425] In the illustrated example, the curved lip 214 acts as a biasing member. Therefore, when the nose section 150 is pressed against the curved lip 214 at the proximal end of the fixation device, the curved lip 214 presses against the nose section, such as against an elastomer band, strip, or section incorporated into the nose section, and imparts a pair of component forces or force vectors to the nose section 150 of the valve opener, including forces acting substantially parallel to the longitudinal axis of the catheter hub 102. In another example, the nose section separates from the fixation device when the male Luer tip contacts the female Luer of the catheter hub. In that situation, the valve can provide the necessary return force to return the valve opener from the distal to the proximal position.

[0426] When the male lure tip 200 is withdrawn, such as when replacing the IV fluid bag attached to the male lure tip 200, the distal force acting on the proximal edges 182 of the two plunger elements 152 by the male lure tip 200 is removed or stopped, and the female lure 204 is not occupied by an external object. As a result, the valve opener 122 can return to its proximal position and be retracted by the male lure tip. In this example, the elasticity of the valve 120 allows the valve flap 194 to return to a more relaxed state, such as moving to the position shown in Figure 8. This repulsive action of the valve flap 194 and the shape of the nose section 150 of the valve opener allow the valve flap to impart a force vector to the nose section 150 so that it moves the valve opener 122 from the distal position shown in Figure 9, as is commonly shown in Figure 8.

[0427] Accordingly, aspects of the present invention are understood to include a catheter assembly or needle device comprising a catheter hub having a catheter tube extending distally, wherein the catheter hub comprises a body having an outer surface and an inner surface forming an internal cavity. A valve and valve opener may be located inside the internal cavity. In one example, a fixing device having a body forming a bore is located proximal to the valve and fixes the valve inside the catheter hub. In one example, the fixing device provides interference with the valve opener as the valve opener advances distally by the male Luer tip. In another example, the male Luer tip abuts against the female Luer of the catheter hub before the nose section of the valve opener contacts the fixing device. The valve opener is configured to open the valve flap of the valve. In one example, interference, deflection, biasing, or compression of the valve flap by the valve opener generates stored energy that provides a force vector including a force vector extending substantially parallel to the longitudinal axis of the catheter hub to return the valve opener from the distal to the proximal position when the male Luer tip is removed from the catheter hub. The fixation device can also provide a return force to the nose compartment, such as a flexible insert in the valve opener, an elastic band, or a region of the nose compartment having material, in order to provide an additional proximal return force. The fixation device can further provide a fixation function to secure the valve within the catheter hub and prevent it from being inadvertently displaced proximal to the catheter hub. The catheter hub may include the catheter hub, valve, valve opener, fixation device, and a needle protruding through the catheter tube. The needle can be attached to the needle hub at its proximal end.

[0428] Since the valve opener can move distal to the valve to open two or more valve flaps, such as when pressed by the tip of the male luer, and the male luer tip can be removed to relax or close the valve flaps until they are closed in the slit, the valve can undergo multiple operating cycles. In this example, the valve can undergo two or more operating cycles. For example, the valve can undergo at least three cycles, at least four cycles, at least five cycles, or more. Each operating cycle may include movement of the valve actuator toward and away from the valve to deflect the valve flaps.

[0429] Referring hereto to Figures 10 and 11, a catheter assembly or needle assembly 100 provided according to further aspects of the present invention may have the same needle and needle hub as described elsewhere in this specification, although the needle and needle hub are shown removed. The needle assembly 100 may also incorporate a needle guard 130, as described elsewhere in this specification.

[0430] In this embodiment, the catheter hub 102, catheter tube 104, valve 120, valve opener 122, and fixing device 124 may be similar to those shown with reference to Figures 6 to 9, with some exceptions. In this embodiment, the fixing device 124 is a retaining ring having a distal end 210 with an outwardly curved lip forming a flange 216 for abutting or contacting the proximal surface of the valve 120, and a wall or body that tapers in the proximal direction from a first dimension to a second larger dimension. Thus, the wall in this embodiment resembles a slope with a high portion of the slope at the distal position and tapers as it extends in the proximal direction. The fixing device 124 has a sloped or inclined surface similar to that in Figures 6 and 7, but does not have the same solid cross-section.

[0431] The proximal end 212 of the fixation device has a proximal edge 218 that can be sized to abut or press against the inner shoulder 176b of the catheter hub 102. When positioned against the inner shoulder 176b, the fixation device 124 can help fix the valve so that it does not displace proximal. Alternatively, if there is a slight interference fit between the proximal end 212 and / or distal end of the fixation device and the inner diameter of the catheter hub 102, the shoulder is not required to fix the fixation device 124 internally. The valve 120 is fixed or supported from distal movement by being positioned against the shoulder 173 (Figure 5) on the distal surface of the valve.

[0432] The fixing device 124 and the nose section 150 of the valve opener 122 are spaced apart from each other at the proximal position of the valve opener in Figure 10. The gap or space between the two provides clearance for the valve opener 122 to move distally and open the valve, such as to deflect the valve flap before closing the gap and contacting or colliding with the fixing device 124. In the illustrated configuration, the working end 180 of the nose section 150 of the valve actuator 122 is located within the bore formed by the fixing device 124, but is spaced apart from or not in contact with the fixing device. The tapered surface of the nose section is also spaced apart from the fixing device. This gap or space allows the valve operating element 122 to move distally forward before colliding with or contacting the fixing device 124. The working end 180 of the valve actuator is shown in contact with the proximal surface of the valve 120. In other examples, the working end may be slightly spaced apart from the proximal surface of the valve.

[0433] Figure 11 is a cross-sectional side view of the assembly of Figure 10, similar to the embodiments of Figures 7 and 9, having a male Luer tip 200 that is inserted into the proximal end 136 of the opening and advances the valve opener 122 into the valve 120 to open the valve flap 194 and open fluid communication between the male Luer tip 200 and the lumen of the catheter tube 104. Although not shown, the male Luer tip 200 may have a threaded collar for engaging with a lug or male thread 202 in the catheter hub to maintain the valve actuator in the distal position and open the valve.

[0434] In the example, the valve opener 122 is configured to move distally as it is advanced by the male Luer tip 200. The amount or distance the valve opener moves distally should be sufficient for the working end 180 and the nose section to deflect the valve flap 194 distally, opening the slit and opening fluid communication between the male Luer tip 200 and the catheter tube 104. In the illustrated example, the working end 180 of the valve opener 122 moves distally to the valve flap, and the valve flap is compressed between the inside of the catheter hub and the tapered surface of the nose section 150, or the valve flap is deflected or deformed distally by the nose section of the valve opener, with or without compression. In some examples, the nose section of the valve actuator is provided with a molded contour having a separate line, etc., by forming a recess in the nose section having a separate contour line or curve. Next, one or more surfaces of the contoured nose section can be used to press and repel the valve, thereby pressing the contoured nose section proximal and returning the valve actuator to its proximal position. For example, one or more contoured surfaces can axially compress, deform, or bias the valve relative to the distal shoulder so that the valve provides an axially directed return force when the male lure tip is removed. In some examples, the operating end 180 is equal to or just before the end of the valve flap 194, but travels a distance sufficient to open the valve for free flow in both directions.

[0435] In the illustrated example, the inclined surface acts as a biasing member. For example, when the nose section 150 is pressed against the inclined surface structure of the fixing device 124 by the male luer tip, the fixing device exerts an opposing biasing force on the nose section 150 of the actuator, such as on the flexible section located within the nose section. Thus, when the nose section 150 is pressed against the inclined surface in interference, the inclined surface of the fixing device 124 imparts a pair of component forces or force vectors to the nose section, including a force acting substantially parallel to the longitudinal axis of the catheter hub. In some examples, the nose section is separated from the fixing device when the male luer tip contacts the female luer of the catheter hub.

[0436] When the male lure tip 200 is withdrawn, such as when replacing the IV fluid bag attached to the male lure tip 200, the distal force acting on the proximal edges 182 of the two plunger elements 152 by the male lure tip 200 is removed or stopped, and the female lure 204 is not occupied by any external object. As a result, the valve opener 122 can return to its proximal position and is now retracted by the male lure tip. In this example, the elasticity of the valve 120 allows the valve flap 194 to return to a more relaxed state, such as moving to the position shown in Figure 10. This repulsive action of the valve flap 194 and the shape of the nose section 150 of the valve opener allow the valve flap to impart a force vector to the nose section 150 so that the valve opener 122 moves from the distal position to the proximal position shown in Figure 11, as is commonly shown in Figure 10. Furthermore, as described above, the inclined structure of the fixing device 124 exerts a return force on the flexible section located in the nose section, thereby moving the valve opener 122 in the proximal direction and returning the valve opener essentially to the position shown in Figure 10.

[0437] Accordingly, aspects of the present invention are understood to include a catheter assembly or needle device comprising a catheter hub having a catheter tube extending distally, and a needle attached to a needle hub, wherein the needle extends through the catheter hub and the catheter tube. The catheter hub comprises a body having an outer surface and an inner surface forming an internal cavity. A valve and valve opener may be located inside the internal cavity. In an example, a fixing device having a body forming a bore is located proximal to the valve and fixes the valve within the catheter hub. The fixing device can provide interference with the valve opener when the valve opener advances distally by the male Luer tip to open the valve flap of the valve, and the interference conforms a vector including a force vector extending substantially parallel to the longitudinal axis of the catheter hub to return the valve opener from the distal position to the proximal position when the male Luer tip is removed from the catheter hub. The fixing device can further provide a fixing function to fix the valve within the catheter hub and prevent the valve from being inadvertently displaced proximal so as not to come out of the catheter hub and provide a return force to the valve opener.

[0438] The valve opener can move to a distal position within the valve to open two or more valve flaps when pressed by the tip of a male luer connector, and can return to a proximal position when the tip of the male luer connector is removed, allowing the valve flaps to relax or close until closure in the slit. Therefore, the valve can undergo multiple operating cycles. In this example, the valve can undergo two or more operating cycles. For example, the valve can undergo at least three cycles, at least four cycles, at least five cycles, or more. Each operating cycle may include movement of the valve actuator toward and away from the valve to deflect the valve flaps.

[0439] Figures 12, 13, and 14 show cross-sectional side, front, and isometric views of three different fixation devices 124 that can embody a retaining ring. These retaining rings 124 can be used with catheter assemblies described elsewhere in this specification. Figure 13 also shows a valve 120 having a retaining ring 124. Referring first to the retaining ring or fixation device 124 of Figure 12, the retaining ring has a ring body 220 having a first end or distal end 210 and a second end or proximal end 212. The ring body 220 has an external dimension that is substantially constant along the length of the ring body, which is substantially cylindrical. Internally, the ring body 220 has a wall thickness that decreases in dimension from the distal end to the proximal end, with the inner diameter of the distal end being smaller than the inner diameter of the proximal end. The inner surface of the ring body 220 forms a bore, which is configured to house a valve opener and compress or bias the nose section of the valve opener to impart a pair of component forces as described above. In another example, the fixation device is sized and shaped such that the male luer tip is separated from the nose section when it contacts the female luer of the catheter hub. In this 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 elastomer or thermoplastic elastomer (TPE) material. Alternatively, the fixation device may be made from a metal material by punching and bending or machining.

[0440] As shown in Figure 12, the cross-section of the ring body 220 has a beveled or inclined surface on the inner surface of the ring body. Furthermore, the inclined surface has a constant incline. In other examples, the incline of the inclined surface is not constant. For example, one or more irregularities or inflection points may exist to create a non-linear contour. Whether or not it has a constant incline, the contour can be selected to generate compression, biasing, or interference between the valve opener 122 and the nose section of the valve opener 122, such as in the flexible section of the nose section, when the valve opener is pressed against the fixing device 124. The compression, biasing, or interference with the valve opener 122 is configured to generate a force vector that includes a force substantially parallel to the longitudinal axis of the valve opener. This, in turn, helps the valve opener move from the distal position to the proximal position. The fixing device 124 in Figure 12 is similar to the fixing devices 124 shown in Figures 4 to 7.

[0441] Figure 13 shows the valve 120 and the fixing device 124. The fixing device 124 may be the same as the fixing device described with reference to Figures 8 and 9, and the valve 120 may be the same as the valve described elsewhere in this specification, such as those referenced in Figures 3 to 7. As shown in the different figures in Figure 13, the valve 120 has a valve body 224 having an outer circumference 226, a proximal surface 228, and a distal surface 230. The proximal surface 228, the distal surface 230, or both surfaces 228, 230 have a first valve portion 168 and a second valve portion 170, as described above.

[0442] The first and second valve portions 168, 170 form regions or sections of different thicknesses. Furthermore, the two regions can be shaped to form the contours of the locations where slits 234 are incorporated to form valve flaps 194. As shown in the figure, the valve 120 has three slits 234 that converge towards the center point and extend outward toward the outer circumference 226, but are shorter than the outer circumference. In this example, the slits 234 are formed by penetrating only the thinner second portion 170 of the valve body 224. In some examples, there may be more or fewer than three slits that form more or fewer valve flaps.

[0443] As previously mentioned, the proximal surface 228 has an annular slit or annular slot 206 for receiving the distal end 210 of the fixing device 214. In some examples, the annular slot is an annular channel having a gap that does not grip both the inner and outer surfaces of the distal end of the fixing device. The fixing device 124 can be made from a thin-walled cylinder such as a metal or plastic material, and the proximal end 212 is curved outward to terminate at a curved lip 214, as well as a rounded corner. The inner surface of the ring body 220 of the fixing device 124 forms a bore, which houses the valve opener and is configured to compress or bias the nose section 150 of the valve opener 122, such as for a flexible section of the nose section, to impart a pair of force components, as described above. More specifically, the rounded corner of the curved lip 214 is configured to compress or bias the nose section of the actuator, thereby imparting a pair of force components. In another example, the fixation device is sized and shaped such that the male Luer tip is separated from the nose compartment when it contacts the female Luer of the catheter hub. As shown in the figure, the curved lip 214 has an outer diameter, which is smaller than the outer diameter of the valve 120. Depending on the internal structure of the catheter hub, the size of the curved lip 214 can be adjusted so that when it is installed inside the catheter hub, the curved lip contacts or abuts against the shoulder, fixing the retaining ring within the internal cavity of the catheter hub.

[0444] Figure 14 shows a fixation device 124 similar to the fixation devices described with reference to Figures 10 and 11. As shown, the ring body 220 has a distal end 210 with a curved lip that forms a flange 216 having a substantially flat wall surface for contacting the surface of the valve. The ring body 220 of the fixation device has a substantially constant wall thickness that tapers outward from a first diameter at the distal end immediately proximal to the flange 216 to a second larger diameter at the proximal end 212, which has a proximal edge 218 for contacting or abutting the inner shoulder of the catheter hub 102 to hold the fixation device 214 within the catheter hub. The wall surface has an inclined surface, such as a slope. The inner surface of the ring body 220 of the fixation device 124 forms a bore, which is configured to house the valve opener and compress or bias the nose section of the valve opener, for example, the section of the nose section that incorporates an elastomer strip, band, or material, thereby applying a pair of component forces as described above. In another example, the fixation device is sized and shaped such that the male luer tip is separated from the nose section when it contacts the female luer of the catheter hub.

[0445] Figure 15 shows different diagrams of an inclined coil spring 238 having multiple interconnected coils 240, all inclined along approximately the same direction. The spring 238 can be made from a metallic material. Figure 15 shows an inclined coil spring 238 in a configuration of length 242, an inclined coil spring in a configuration of a ring 244 with both ends of the spring connected, and a side view of a single inclined coil 240 which is approximately elliptical. Inclined coil springs are well known in the art of springs, and the coil of an inclined coil spring is understood to be radially deflectable or compressible with respect to the centerline of the ring, which is understood to protrude in and out of the page at the center of the spring ring 244.

[0446] Referring to Figure 16 in addition to Figure 15, the catheter assembly 100 of this embodiment is shown, similar to the catheter assemblies of Figures 4 to 11, with a few exceptions. In this embodiment, an inclined coil spring 238 with a spring ring 244 configuration is incorporated as a fixing device 124. The inclined coil spring 238 as a fixing device 124 abuts against the proximal surface 228 of the valve 120 and abuts against the inner shoulder portion 176 of the interior 123 of the catheter hub 102, thereby fixing the spring ring inside the hub. The proximal surface 228 of the valve 120 may have a fitting recess for fitting or supporting the distal arc of the inclined coil spring. In the proximal position of the valve opener in Figure 16, the coil 240 of the inclined coil spring 238 is in contact with both the inner surface of the catheter hub 102 and / or the valve 120 and the nose section 150 of the valve opener 122. In other examples, the coil can be spaced away from the surface of the nose section 150, such as not contacting the nose section 150 in the proximal position of the valve opener.

[0447] Figure 17, similar to Figures 7, 9, and 11, shows a valve opener or actuator 122 being pushed distally by the male Luer tip 200 of a medical instrument to open or deflect the valve flap of valve 120. An inclined coil spring 238 is shown compressed by the nose section 150 of the valve opener 122. More specifically, each coil 240 of the multiple coils of the inclined coil spring 238 is compressed by the nose section 150 of the valve opener 122 because the coils of the inclined coil spring are compressed when compressed radially along the centerline of the spring ring. Since coils tend to be incompressible or rebound, the compression of the coils generates a force vector on the nose section 150. The force vector generated on the nose section includes a force substantially parallel to the longitudinal axis of the valve opener. When the coil is compressed along one side by the valve, or when the coil is compressed along one side by the catheter hub 102, the distal axial force vector opposes the proximal valve surface of the valve 120, and the proximal force vector opposes the valve opener 122.

[0448] When the male Luer tip 200 is removed, the coil 240 of the spring 238 expands to press against the nose compartment 150, applying a pair of component forces including a proximal axial force vector. This then helps to push the valve opener 122 proximal, returning the valve opener 122 to its proximal position and the valve 120 to its closed position, as shown in Figure 16. The force generated by the spring ring 244 to move the valve opener 122 after the removal of the male Luer tip 200 is added to the force generated by the valve flap of the valve 120, which returns to a relaxed or closed state to close the valve slit after the removal of the male Luer tip. The proximal force allows the valve opener 122 to return from its distal position to its proximal position within the catheter hub 102 after the male medical device has been detached from the catheter hub 123.

[0449] The valve opener can move to a distal position within the valve to open two or more valve flaps when pressed by the tip of a male luer connector, and can return to a proximal position when the tip of the male luer connector is removed, allowing the valve flaps to relax or close until they are closed in the slit. Therefore, the valve can undergo multiple operating cycles. In this example, the valve can undergo two or more operating cycles. For example, the valve can undergo at least three cycles, at least four cycles, at least five cycles, or more. Each operating cycle may include movement of the valve actuator toward and away from the valve to deflect the valve flaps.

[0450] Figures 18 and 19 show yet another embodiment of a catheter assembly similar to the catheter assembly 100 in Figures 4-11 and 16-17, with a few exceptions. In this embodiment, the valve 120 is provided with an integrally or integrally formed retaining device 124. In this embodiment, the integrally or integrally formed retaining device 124 may be a retaining skirt section 250 having a substantially cylindrical length with a triangular cross-section and an opening proximal end, similar to the triangular cross-section of the retaining device 124 in Figures 4-7. The additional surface area of ​​the outer surface of the skirt section 250, or the retaining device, helps to further retain the valve 120 within the catheter hub 102 when the needle is removed and the valve opener 122 is pressed by the male Luer tip 200 (Figure 19) to open the valve 120.

[0451] When the valve opener 122 is pushed distally by the male Luer tip 200, the skirt section 250 is compressed, deformed, or biased by the tapered nose section 150 and the inside of the catheter hub 102 to a size that can generate stored energy. As a result, when the male tip 200, such as the male Luer of a syringe or the tip of a dosing set, is removed, the triangular skirt 250 expands, imparting a pair of component forces to the nose section 150, including a proximal axial force vector. This then helps push the valve opener 122 proximal, as shown in Figure 18, returning the valve opener 122 from its distal position to its proximal position and returning the valve 120 to its closed position.

[0452] The valve opener can move to a distal position within the valve to open two or more valve flaps when pressed by the tip of a male luer connector, and can return to a proximal position when the tip of the male luer connector is removed, allowing the valve flaps to relax or close until they are closed in the slit. Therefore, the valve can undergo multiple operating cycles. In this example, the valve can undergo two or more operating cycles. For example, the valve can undergo at least three cycles, at least four cycles, at least five cycles, or more. Each operating cycle may include movement of the valve actuator toward and away from the valve to deflect the valve flaps.

[0453] Figures 20 and 21 show yet another embodiment of a catheter assembly similar to the catheter assembly 100 of Figures 4-11 and 16-19, with a few exceptions. In this embodiment, the fixation device 124 is a retaining ring, which is provided with an integrated or integrally formed flexible flap or leaf spring 256. Referring to Figure 22, the fixation device 124 is similar to the fixation device described with reference to Figures 10, 11 and 14. As shown, the fixation device has a ring body 220 having a distal end 210 with a curved lip that forms a flange 216 having a substantially flat wall surface for contacting the surface of the valve. The ring body 220 has a substantially constant wall thickness that tapers outward from a first diameter at the distal end immediately proximal to the flange 216 to a second larger diameter at the proximal end 212, which has a proximal edge 218 that can abut or contact the inner shoulder of the catheter hub in order to hold the fixation device 214 within the catheter hub. Alternatively, the shoulder portion can be omitted, and the proximal edge 218 can form an interlocking fit with the inner edge of the catheter hub. The wall surface has an inclined surface, such as a slope. The inner surface of the ring body 220 of the fixing device 124 forms a bore, which houses the valve opener and is configured to compress or bias the nose section of the valve opener to apply a pair of component forces as described above.

[0454] In this embodiment, two or more leaf springs 256, for example, three to eight leaf springs 256, can be provided as part of the retaining ring 124 for holding the valve 120. In another example, only one leaf spring may be incorporated. The leaf springs 256 can be formed by forming symmetrical three-sided notches in the ring body 220 and bending the notches inward to form the leaf springs. However, the notches may be other than three-sided notches, such as partial circular notches or multi-sided notches with more than three sides. Where three-sided notches are preferred, any number of notches can be used to form leaf springs on the retaining device to generate a force vector to the valve opener. After forming one or more notches, the direction of bending of the notches to form the leaf springs is such that one or more leaf springs can contact the nose section of the valve actuator.

[0455] The leaf spring 256 can be sized such that, when the valve opener 122 is pushed distally by the male luer tip 200, the leaf spring 256 expands outward from the centerline of the retaining ring by the tapered nose section 150 of the valve opener 122, deflecting outward or biasing outward, as shown in Figure 21. As a result, when the male tip 200 is removed, the leaf spring 256 becomes compressed or de-biased, such as returning to their de-biased state to impart a pair of component forces to the nose section 150, including a proximal axial force vector. The biasing force of the leaf spring helps push the valve opener 122 proximal, returning the valve opener 122 from its distal position to its proximal position, and allowing the valve 120 to return to its closed position, as shown in Figure 20. The force of the leaf spring 256 is added to the force generated by the valve flaps of the valve, which return to their relaxed or closed position to close the valve slit after the removal of the male lure tip 200. In embodiments having one or more leaf springs, the nose section may be rigid without any of the flexible one or more sections that may be optionally included.

[0456] The valve opener can move to a distal position within the valve to open two or more valve flaps when pressed by the tip of a male luer, and can return to a proximal position when the tip of the male luer is removed, allowing the valve flaps to relax or close until they are closed in the slit. Therefore, the valve can undergo multiple operating cycles. In this example, the valve can undergo two or more operating cycles. For example, the valve can undergo at least three cycles, at least four cycles, at least five cycles, or more. Each operating cycle may include movement toward and away from the valve to deflect the valve flaps.

[0457] Figures 23 and 24 show yet another embodiment of a catheter assembly similar to the catheter assembly 100 of Figures 4-11 and 16-21, with a few exceptions. For example, this catheter assembly may have a detached needle and needle hub, which may be the same as those described elsewhere in this specification. The catheter hub 102 of Figure 23 may also have a pair of wings 260 extending in opposite directions lateral to the longitudinal axis of the catheter hub 102 at the bottom of the catheter hub. Figure 23 is shown as a top cross section view. The pair of wings 260 may be used by the operator, for example with adhesive tape or adhesive bandage, to secure the catheter hub to the patient after successful venipuncture. Figure 24 shows the catheter assembly of Figure 23 without wings. The needle assembly 100 may also incorporate a needle guard 130 (Figure 5), as described elsewhere in this specification.

[0458] In this embodiment, similar to the embodiments shown in Figures 20 to 22, the fixing device 124 is a retaining ring, and the retaining ring is provided with an integrated or integrally formed flexible flap or leaf spring 256. However, as will be further described below, the fixing device 124 is an eyelet from which one or more leaf springs 256 extend from a flange.

[0459] Referring to Figure 25, the fixation device 124 has an eyelet configuration and can be used in the catheter embodiments of Figures 23 and 24. As shown, the fixation device 124 has a flange 216 for a ring body 220 having an outer diameter (OD) and an inner diameter (ID) that form an opening. The flange 216 may have a thickness that can be the thickness of the metal sheet used to form the eyelet. The thickness of the flange and the thickness of the leaf spring may be the same or approximately the same. If the flange and the leaf spring are integrally formed from a single metal sheet, the thickness of the flange and the thickness of each leaf spring may be the same within the manufacturing tolerance of the metal sheet thickness.

[0460] In the illustrated example, no cylindrical or elongated hollow body extends from the flange 216. Instead, two or more leaf springs 256, for example, three to eight leaf springs 256 or at least one leaf spring, can extend directly from the flange 216. As shown in the illustration, four leaf springs 256 are incorporated into the flange 216, with each leaf spring at approximately 90 degrees from an adjacent leaf spring. The leaf springs can be spaced equally along the flange contour. The leaf springs 256 can extend proximal from the flange ID and can terminate at a proximal end edge 270. The proximal end edges of the leaf springs 256 may be flat or rounded. The leaf springs 256 can be spaced equally or approximately equally along the flange ID. Each leaf spring may have sufficient width and length to generate a component force in the nose section 150 of the valve opener 122, and as will be further described below, all leaf springs 256 can collectively generate a proximal force that can move the valve opener 122 from a distal to a proximal position after the male lure tip has been removed.

[0461] In the illustrated embodiment, a pair of internal notches or slits 262 are provided on the flange ID and both side edges of each leaf spring 256, allowing each leaf spring to have a bend 266 with a bending radius recessed from the flange ID. In other examples, the pair of internal notches 262 can be omitted, and the proximal bend in each bend 266 can be angular (square) or right-angled. Alternatively, when no internal notches or insufficient internal notches are incorporated, the bending radius can extend somewhat inward from the flange ID.

[0462] Referring again to Figure 23, the retaining ring 124 can be configured to secure the valve 120 inside the catheter hub interior 123, like other retaining rings described elsewhere in this specification. In this embodiment, the valve 120 may be supported on its distal surface by the inner shoulder 173, on its proximal surface by the flange 216 of the retaining ring 124, and on the proximal inner shoulder 216 of the flange 176b (Figure 5). Thus, in the illustrated position, the valve 120 is secured or supported inside the catheter hub interior.

[0463] In the illustrated valve opener proximal position, the operating end 180 of the valve opener 122 can either contact the proximal surface of the valve 120 or be spaced away from it. Regardless of whether there is contact between the valve opener 122 and the valve 120 in the valve opener proximal position, the nose section 150 is positioned within the boundary formed by the leaf spring 256, but does not contact the leaf spring 256. For example, in the valve opener proximal position, the nose section 150 i...

Claims

1. A catheter assembly (100), A catheter tube (104) having a lumen, a distal end opening, and a proximal end attached to the distal end of a catheter hub (102), wherein the catheter hub (102) comprises a catheter body (126) having an outer surface and an inner surface forming an internal cavity (123) having at least one shoulder portion (173), A needle (108) having a needle tip (114) at its distal end and a proximal end attached to a needle hub (106), wherein the needle (108) protrudes through the catheter hub (102) and catheter tube (104), and has a needle tip (114) that protrudes distally to the distal end opening when ready for use, A valve (120) having a valve disc (121) positioned in an internal cavity (123) of a catheter hub (102), wherein the valve disc (121) comprises at least one slit (234) and at least two flaps (194), a proximal surface, a distal surface, and the distal surface being in contact with at least one shoulder portion (173), and the valve, A skirt section (250) extending from the valve disc (121), the skirt section (250) includes a wall having an outer surface and an inner surface forming the interior of the skirt, and a proximal end face (290) of the skirt, and the skirt section (250) is in contact with the inner surface of the catheter hub (102), A valve actuator (122) is positioned in the internal cavity (123) of a catheter hub (102), the valve actuator (122) having a nose compartment (150) at its distal end and a proximal compartment (157) proximal to the nose compartment (150), the nose compartment (150) including a bore and working end (180) for fluid flow at its most distal end, and the proximal compartment (157) having at least one void for fluid flow through or across it, the valve actuator (122) is positioned in the proximal position within the internal cavity (123) and is slidable to the distal position within the internal cavity (123) when pushed by a medical device, the nose compartment (150) is located in at least a portion of the inside of the skirt in the ready-to-use position, the valve actuator (122) and Equipped with, Here, the two spaced-apart contact surfaces (295, 298) are located in the ready-to-use position near the operating end (180) of the valve opener (122) and near the proximal end surface (290) of the skirt, and the contact surfaces (295, 298) are sized and shaped to contact the proximal end surface (290) of the skirt when the valve actuator (122) is in the distal position. Catheter assembly.

2. The catheter assembly according to claim 1, further comprising a needle guard (130) positioned on the side of the needle (108) in the ready-to-use position and having a protective surface that moves to a distal position of the needle tip (114) in the protective position to cover the needle tip (114) from accidental needle sticks.

3. The catheter assembly according to claim 1 or 2, wherein the skirt section has a slanted cross-section, and the proximal end face (290) of the skirt is located at the proximal end of the slanted cross-section.

4. The catheter assembly according to any one of claims 1 to 3, wherein the nose section (150) of the valve actuator (122) has a first slope extending to a transition section (296), the transition section (296) has a second slope, and the second slope and the first slope have different slope values.

5. The catheter assembly according to any one of claims 1 to 4, wherein the valve disc (121) has a first portion (168) having a first thickness and a second portion (170) having a second thickness, the first thickness being greater than the second thickness.

6. The catheter assembly according to claim 5, wherein at least one slit (234) is formed through a second portion (170) of the valve (120).

7. The catheter assembly according to claim 2, wherein at least one stabilizing element (158) comprises a first end connected to a first plunger element (152) of a valve actuator (122) and a second end connected to a second plunger element (152) of a valve actuator (122), and the stabilizing element (158) further comprises a distal edge (158a) and a proximal edge (158b).

8. The catheter assembly according to claim 7, wherein the needle guard (130) comprises a proximal wall (140) having a periphery (192) forming an opening, and at least one arm (188, 190) extending distal to the proximal wall (140), the at least one arm (188, 190) comprising an elongated arm portion (188c, 190c), a distal wall (188b, 190b), and an elbow (188a, 190a) positioned between the elongated arm portion and the distal wall, wherein a single bend is positioned between the elongated arm portion and the distal wall, forming a smooth or flat outer shape at the elbow where the needle guard contacts the distal edge.

9. The catheter assembly according to claim 8, wherein the catheter hub (102) comprises a side port (360) having an elongated body (362) having a bore (364), and the elongated body (362) extends at a certain angle relative to the catheter body (126).

10. The catheter assembly according to any one of claims 1 to 9, further comprising a grip paddle (372) having a body that extends laterally to the axis formed by the needle (108).

11. The catheter assembly according to claim 7, wherein the distal edge (158a) of the stabilizing element (158) is provided with a tapered edge (392) that starts near the outer surface of the stabilizing element (158) and slopes toward the inner surface of the stabilizing element (158).

12. A method for manufacturing a catheter assembly (100), A catheter tube (104) having a lumen, a distal end opening, and a proximal end attached to the distal end of a catheter hub (102) is attached, where the catheter hub (102) comprises a catheter body (126) having an outer surface and an inner surface forming an internal cavity (123) having at least one shoulder portion (173). A needle (108) having a needle tip (114) at its distal end and a needle tip (114) at its proximal end is attached to a needle hub (106), where the needle (108) protrudes through the catheter hub (102) and catheter tube (104), and in the ready-to-use position, has a needle tip (114) that protrudes distally to the distal end opening. A valve (120) having a valve disc (121) is placed in the internal cavity (123) of a catheter hub (102), where the valve disc (121) comprises at least one slit (234) and at least two flaps (194), a proximal surface and a distal surface, the distal surface being in contact with at least one shoulder portion (173). A skirt section (250) extends from the valve disc (121), where the skirt section (250) includes a wall having an outer surface and an inner surface forming the interior of the skirt, and a proximal end face (290) of the skirt, and the skirt section (250) is in contact with the inner surface of the catheter hub (102). A valve actuator (122) is positioned in the internal cavity (123) of the catheter hub (102), where the valve actuator (122) has a nose compartment (150) at its distal end and a proximal compartment (157) proximal to the nose compartment (150), the nose compartment (150) comprising a bore for fluid flow and an operating end (180) at its most distal end, the proximal compartment (157) having at least one void for fluid flow through or across it, the valve actuator (122) is positioned in the proximal position within the internal cavity (123) and is slidable to the distal position within the internal cavity (123) when pushed by a medical device, where the nose compartment (150) is positioned in at least a portion of the inside of the skirt in the ready-to-use position. Equipped with, Here, the two spaced-apart contact surfaces (295, 298) are positioned in the ready-to-use position proximal to the operating end (180) of the valve opener (122) and proximal to the skirt proximal end surface (290), and the contact surfaces (295, 298) are sized and shaped such that they contact the skirt proximal end surface (290) when the valve actuator (122) is in the distal position. Manufacturing method.

13. The manufacturing method according to claim 12, further comprising positioning a needle guard (130) in the internal cavity (123) of the catheter hub (102), wherein the needle guard is located on the side of the needle (108) in the ready-to-use position and moves distal to the needle tip (114) in the protected position, having a protective surface that covers the needle tip (114) from accidental needle sticks.

14. The manufacturing method according to claim 13, further comprising extending a side port (360) having an elongated body (362) with a bore (364) at a certain angle with respect to the catheter body (126).

15. The manufacturing method according to claim 13 or 14, wherein the needle guard (130) comprises a proximal wall (140) having a periphery (192) forming an opening, and at least one arm (188, 190) extending distally from the proximal wall (140), the at least one arm (188, 190) comprising an elongated arm portion (188c, 190c), a distal wall (188b, 190b), and an elbow (188a, 190a) disposed between the elongated arm portion and the distal wall, wherein a single bend is disposed between the elongated arm portion and the distal wall to form a smooth or flat outer shape at the elbow where the needle guard contacts the distal edge.

16. A catheter assembly (100), A needle (108) attached to the needle hub (106), A catheter tube (104) attached to a catheter hub (102), A valve (120) and a valve actuator (122) are located inside the interior (123) of the catheter hub (102), and the valve (120) has a plurality of valve flaps (194). The valve skirt (250) that forms the inside of the skirt and Equipped with, The valve actuator (122) is movable toward the valve (120) to deflect multiple valve flaps (194) to the open valve position, and is movable toward the valve (120) to allow the valve flaps (194) to return to the closed valve position. A catheter assembly in which the needle (108) protrudes through a valve (120), a valve actuator (122), a catheter hub (102), and a catheter tube (104) in a ready-to-use position.

17. A catheter assembly (100), A needle (108) attached to the needle hub (106), A catheter tube (104) attached to a catheter hub (102), A valve (120) and a valve actuator (122) are located inside the interior (123) of the catheter hub (102), wherein the valve (120) comprises a valve disc (121) having a plurality of valve flaps (194). A fixing device (124) that holds the valve (120) inside the interior (123), Equipped with, The valve actuator (122) is movable toward the valve (120) to deflect multiple valve flaps (194) to the open valve position, and is movable toward the valve (120) to allow the valve flaps (194) to return to the closed valve position. A catheter assembly in which the needle (108) protrudes through a valve (120), a valve actuator (122), a catheter hub (102), and a catheter tube (104) in a ready-to-use position.

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