Patent Description:
Common types of intravenous catheter are peripheral IV catheters ("PIVCs"), peripherally inserted central catheters ("PICCs"), and midline catheters. Intravenous catheters may include "over-the needle" catheters, which may be mounted over a needle having a sharp distal tip. The sharp distal tip may be used to pierce skin and the vasculature of the patient. Insertion of the intravenous catheter into the vasculature may follow the piercing of the vasculature by the needle. The needle and the intravenous catheter are generally inserted at a shallow angle through the skin into the vasculature of the patient with a bevel of the needle facing up and away from the skin of the patient.

The international patent application published as <CIT> discloses a system for controlling fluid flow in a catheter assembly.

In order to verify proper placement of the introducer needle and/or the intravenous catheter in the vasculature, a user generally confirms that there is flashback of blood, which may be visible to the user. Once placement of the introducer needle within the vasculature has been confirmed, the user may temporarily occlude flow in the vasculature and withdraw the introducer needle, leaving the intravenous catheter in place for future blood withdrawal and/or fluid infusion.

In some instances, the introducer needle may include a notch disposed towards a distal end of the introducer needle, and in response to the distal tip of the introducer needle being positioned within the vasculature, blood may flow proximally through a needle lumen, exit the needle lumen through the notch, and then travel proximally between an outer surface of the introducer needle and an inner surface of the intravenous catheter. Accordingly, where the intravenous catheter is at least partially transparent, the user may visualize a small amount of primary blood flashback within the catheter tubing. In some instances, in addition to the primary blood flashback, the user may also visualize a small amount of secondary blood flashback in a chamber proximal to the intravenous catheter, thereby confirming placement of the intravenous catheter within the vasculature.

Presence of a vasculature entrance indicator, such as primary and/or secondary blood flashback, may facilitate successful placement of intravenous catheters. However, visualization of blood flashback by the user can be compromised due to blood pressure variations. Blood pressure may vary significantly different in a static venous versus a tourniquet situation, even in a normal patient. The chamber may not provide noticeable flashback with difficult vein insertions and/or may not provide a lasting signal with high blood pressures.

The aforementioned problems are solved according to the invention by means of a catheter system according to appended claim <NUM>.

The present disclosure generally relates to catheter devices, systems, and methods (methods not according to the claimed invention) for flashback visualization at various blood pressures.

A catheter system according to the invention includes the features of appended claim <NUM>, with preferred embodiments of the invention being defined according to the dependent claims.

In some embodiments, the plug may be monolithically formed as a single unit. In some embodiments, the plug may be press fit within the outer housing.

In some embodiments, the proximal end of the introducer needle may be secured within the plug, and the plug may be a needle hub. In other embodiments, the plug may include a luer adapter, which may be coupled to a proximal end of the outer housing. In some embodiments, the luer adapter may include a luer lock or luer slip connector. In some embodiments, the luer adapter may include a male or female luer connector.

In some embodiments, a depth of the first groove may be greater than a depth of the second groove.

According to the invention, the grooves of the outer surface of the plug accommodate varying blood pressures and gauges of introducer needles or catheters. In some embodiments, the first groove may be tuned for a different blood pressure or gauge than the second groove. In some embodiments, for tourniquet blood pressure, the first groove, which, according to the invention, has a greater volume than the second groove, may provide a lasting indication of advancement of the introducer needle within the vein. In some embodiments, for venous pressure, the second groove, which may be shallow and which, according to the invention, has a high surface-area-to-volume ratio compared to the first groove, may provide noticeable blood movement despite low flow rate.

In some embodiments, a proximal end of the first groove may be vented and a proximal end of the second groove may be vented. In some embodiments, the first groove and the second groove may be disposed on a top of the plug, which may facilitate visibility by the user. In some embodiments, the first groove and the second groove may be generally aligned with a longitudinal axis of the plug.

In some embodiments, the outer surface of the plug may include a cavity. In some embodiments, the proximal end of the introducer needle may be disposed within the cavity. In some embodiments, a distal end of the first groove and a distal end of the second groove may be proximate the cavity.

In some embodiments, the grooves may further include one or more of the following:
a third groove, a fourth groove, and a fifth groove (which may be referred to in the present disclosure collectively as the "grooves").

In some embodiments, the third groove may have a third surface-area-to-volume ratio. In some embodiments, the first surface-area-to-volume ratio may be less than the third surface-area-to-volume ratio. In some embodiments, the first groove has a greater volume than the third groove.

In some embodiments, the second groove and the third groove may be similar or identical. In some embodiments, the third surface-area-to-volume ratio may be equal to the second surface-area-to-volume and/or a volume of third groove may be equal to the volume of the second groove. In some embodiments, the second groove and the third groove may be disposed on opposing sides of the first groove and/or may be symmetric about the first groove. In some embodiments, a symmetric pattern of the second groove and the third groove about the first groove may facilitate visualization of blood flashback despite gravity bias due to the user's grip technique.

In some embodiments, the fourth groove may have a fourth surface-area-to-volume ratio and/or the fifth groove may have a fifth surface-area-to-volume ratio. In some embodiments, the first surface-area-to-volume ratio may be less than the fourth surface-area-to-volume ratio and/or the fifth surface-area-to-volume ratio. In some embodiments, the first groove has a greater volume than the fourth groove and the fifth groove. In some embodiments, the fourth groove and the fifth groove may be disposed on opposing sides of the first groove and outwardly from the second groove and the third groove. In some embodiments, the fourth groove and the fifth groove may be disposed on opposing sides of the first groove and/or may be symmetric about the first groove. In some embodiments, a symmetric pattern of the fourth groove and the fifth groove may facilitate visualization of blood flashback despite gravity bias due to the user's grip technique.

In some embodiments, the second groove, the third groove, the fourth groove, or the fifth groove may include one or more pockets extending generally perpendicular to a longitudinal axis of the plug and spaced along a length of one or more of the second groove, the third groove, the fourth groove, and the fifth groove.

In some embodiments, one or more of the grooves may be spaced apart by a capillary effect gap, which may pull blood flashback quickly. In some embodiments, the capillary effect gap and/or one or more other portions of the plug may be constructed of a hydrophilic material. In some embodiments, the first groove and the second groove and/or the first groove and the third groove may be spaced apart by the capillary effect gap. In some embodiments, a volume of the capillary effect gap may be less than one or more of the following: the first groove, the second groove, the third groove, the fourth groove, and the fifth groove. In some embodiments, the capillary effect gap may be filled by blood flashback prior to one or more of the following: the first groove, the second groove, the third groove, the fourth groove, and the fifth groove.

It is to be understood that both the foregoing general description and the following detailed description are examples and explanatory and are not restrictive of the invention as claimed. It should be understood that the various embodiments are not limited to the arrangements and instrumentality shown in the drawings. It should also be understood that the embodiments may be combined, or that other embodiments may be utilized and that structural changes, unless so claimed, may be made without departing from the scope of the various embodiments of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense.

Referring now to <FIG>, according to the invention, a catheter system <NUM> includes a catheter assembly <NUM>, which includes a catheter adapter <NUM>. The catheter adapter <NUM> includes a distal end <NUM>, a proximal end <NUM>, and a lumen <NUM> extending through the distal end <NUM> and the proximal end <NUM>. The catheter system <NUM> includes a catheter <NUM>, which extends distally from the distal end <NUM> of the catheter adapter <NUM>.

In some embodiments, the catheter system <NUM> may include a peripheral intravenous catheter system, such as, for example, the BD NEXIVA™ Closed IV Catheter system, the BD CATHENA™ Catheter system, the BD VENFLON™ Pro Safely Shielded IV Catheter system, the BD NEOFLON™ IV Cannula system, the BD INSYTE™ AUTOGUARD™ BC Shielded IV Catheter system, or another suitable peripheral intravenous catheter system. In some embodiments, the catheter system <NUM> may include an integrated catheter system having an integrated extension tube or a non-integrated catheter system. In some embodiments, the catheter system <NUM> may include a PICC system or a midline catheter system.

According to the invention, the catheter system <NUM> includes a needle assembly <NUM> coupled to the catheter assembly <NUM>. The needle assembly <NUM> includes a plug <NUM> and an outer housing <NUM>. According to the invention the needle assembly <NUM> includes an introducer needle <NUM>, which includes a proximal end <NUM> and a sharp distal tip <NUM>. In some embodiments, the plug <NUM> may be monolithically formed as a single unit. In some embodiments, the plug <NUM> may be press fit within the outer housing <NUM>. In some embodiments, the proximal end <NUM> of the introducer needle <NUM> may be secured within the plug <NUM>, and the plug <NUM> may be a needle hub.

In other embodiments, the plug <NUM> may include a luer adapter, which may be coupled to a proximal end of the outer housing, as illustrated, for example, in <CIT>, entitled "BLOOD COLLECTION DEVICES, SYSTEMS, AND METHODS FACILITATING BLOOD FLASHBACK,". In some embodiments, the luer adapter may include a luer lock or luer slip connector. In some embodiments, the luer adapter may include a male or female luer connector.

In some embodiments, an outer surface of the plug <NUM> may include multiple grooves, which may be configured to receive blood flashback. In some embodiments, in response to the introducer needle <NUM> being inserted into a vein of a patient, blood flashback may travel from the sharp distal tip <NUM> through the proximal end <NUM> of the introducer needle <NUM> and into the plug <NUM>, where the blood flashback may enter the grooves. Additionally, in some embodiments, the introducer needle <NUM> may include a notch, which may allow blood flashback to travel between an outer surface of the introducer needle <NUM> and an inner surface of the catheter <NUM>. In some embodiments, the proximal end <NUM> of the introducer needle <NUM> may include a notch or opening.

Referring now to <FIG>, according to the invention, the grooves include a first groove <NUM> and a second groove <NUM>. According to the invention, the first groove <NUM> has a first surface-area-to-volume ratio, and the second groove <NUM> has a second surface-area-to-volume ratio. According to the invention, the first surface-area-to-volume ratio is less than the second surface-area-to-volume ratio. According to the invention, the first groove <NUM> has a greater volume than the second groove <NUM>. In some embodiments, a depth <NUM> of the first groove <NUM> may be greater than a depth <NUM> of the second groove <NUM>. In some embodiments, a width <NUM> of the first groove <NUM> may be greater than a width <NUM> of the second groove <NUM>. In some embodiments, a width <NUM> of the second groove <NUM> may be greater than the depth <NUM> of the second groove <NUM>. In some embodiments, a width <NUM> of the first groove <NUM> may be approximately equal to the depth <NUM> of the first groove <NUM>.

In some embodiments, sides of the first groove <NUM> may be formed by opposing walls. In some embodiments, the width <NUM> of the first groove <NUM> may correspond to a distance between the opposing walls. In some embodiments, sides of the second groove <NUM> may be formed by other opposing walls. In some embodiments, the walls and the other opposing walls may contact the outer housing <NUM> to seal flashback blood within the first groove <NUM> and the second groove <NUM>.

In some embodiments, the width <NUM> of the second groove <NUM> may correspond to a distance between the other opposing walls. In some embodiments, one of the opposing walls may correspond to one of the other opposing walls, which may be shared between the first groove <NUM> and the second groove <NUM>. In some embodiments, the depth <NUM> of the first groove <NUM> may correspond to a height of the opposing walls or a distance from a bottom of the first groove <NUM> to an inner surface of the outer housing <NUM>. In some embodiments, the depth <NUM> of the second groove <NUM> may correspond to a height of the other opposing walls or a distance from a bottom of the second groove <NUM> to the inner surface of the outer housing <NUM>.

According to the invention, the grooves of the outer surface of the plug <NUM>, that is the first groove <NUM> and the second groove <NUM>, accommodate varying blood pressures and gauges of introducer needles or catheters. In some embodiments, the first groove <NUM> may be tuned for a different blood pressure or gauge than the second groove <NUM>. In some embodiments, for tourniquet blood pressure, the first groove <NUM>, which, according to the invention, has a greater volume than the second groove, may provide a lasting indication of advancement of the introducer needle <NUM> within the vein. In some embodiments, for venous pressure, the second groove <NUM>, which may be shallow and which, according to the invention, has a high surface-area-to-volume ratio compared to the first groove <NUM>, may provide noticeable blood movement of the blood flashback despite low flow rate.

In some embodiments, the first groove <NUM> may facilitate visualization of blood flashback at high blood pressures or large gauges, such as, for example, <NUM>-<NUM> Ga. Low blood pressure may occur in difficult vein access (DVA) situations. In some embodiments, the second groove <NUM> may facilitate visualization of blood flashback at low blood pressures or small gauges, such as, for example, <NUM>-<NUM> Ga.

In some embodiments, a proximal end of the first groove <NUM> may be vented and a proximal end of the second groove <NUM> may be vented. In these embodiments, the plug <NUM> may include one or more vents <NUM>, which may each include a microgroove that may vent air while preventing blood from passing. In some embodiments, the vents <NUM> may include a porous membrane that may vent air while preventing blood from passing. In some embodiments, the vents <NUM> may be proximate the first groove <NUM> and/or the second groove <NUM>.

Referring now to <FIG>, in some embodiments, the vents <NUM> may be disposed on a bottom of the plug <NUM>, which may facilitate better fluid containment. In some embodiments, flashback may flow proximally through the first groove <NUM> and the second groove <NUM> and then down one or more sides of the plug <NUM> to a location proximate the vents <NUM>. In some embodiments, a proximal end of the plug <NUM> may include a seal <NUM>, which may include a rib and/or may extend from one side of the vents <NUM> to the other.

Referring back to <FIG>, in some embodiments, the first groove <NUM> and the second groove <NUM> may be disposed on a top of the plug <NUM>, which may facilitate visibility by the user when the catheter system <NUM> is in the insertion configuration and inserted into the patient. In some embodiments, a bevel of the sharp distal tip <NUM> may face upwards or towards a top of the catheter system <NUM>, as illustrated in <FIG>. In some embodiments, the first groove <NUM> and the second groove <NUM> may be generally aligned with a longitudinal axis <NUM> of the plug <NUM>, which may facilitate easy visualization. In other embodiments, one or more of the grooves may be curved or serpentine to increase blood flashback duration.

In some embodiments, the outer surface of the plug <NUM> may include a cavity <NUM>. In some embodiments, the proximal end of the introducer needle <NUM> may be disposed within the cavity <NUM>. In some embodiments, a distal end of the first groove <NUM> and a distal end of the second groove <NUM> may be proximate the cavity <NUM>. In some embodiments, the cavity <NUM> may be deeper than the first groove <NUM> and/or the second groove <NUM>. In some embodiments, blood travelling through a fluid pathway of the catheter system <NUM> may be forced from the cavity <NUM> to an outside of the plug <NUM>, which may improve visibility of the blood within the fluid pathway to the user.

Referring now to <FIG>, a plug <NUM> of the catheter system <NUM> is illustrated, according to some embodiments. In some embodiments, the plug <NUM> may be similar or identical to the plug <NUM> in terms of one or more included features and/or operation. In some embodiments, an outer surface of the plug <NUM> may include multiple grooves. In some embodiments, the grooves may include one or more of the following in addition to the first groove <NUM> and the second groove <NUM>: a third groove <NUM>, a fourth groove <NUM>, and a fifth groove <NUM>. In some embodiments, the third groove <NUM> may be similar or identical to the second groove <NUM> in terms of one or more included features and/or operation. According to the invention, the outer housing <NUM> seals a top of the grooves of the following to prevent blood from flowing out the top of the grooves.

According to the invention, the first surface-area-to-volume ratio of the first groove <NUM> is less than a second surface-area-to-volume ratio of the second groove <NUM> and may be less than a third surface-area-to-volume ratio of a third groove <NUM>. According to the invention, the first groove <NUM> has a greater volume than the second groove <NUM> and may have a greater volume than the third groove <NUM>. In some embodiments, the second groove <NUM> and the third groove <NUM> may be similar or identical.

In some embodiments, the second groove <NUM> and the third groove <NUM> may be disposed on opposing sides of the first groove <NUM> and/or may be symmetric about the first groove <NUM>. In further detail, in some embodiments, a shape of the second groove <NUM> may be a mirror image of a shape of the third groove <NUM>. In some embodiments, a symmetric pattern of the second groove <NUM> and the third groove <NUM> about the first groove <NUM> may facilitate visualization of blood flashback despite gravity bias due to the user's grip technique.

In some embodiments, the first surface-area-to-volume ratio may be less than a fourth surface-area-to-volume ratio of the fourth groove <NUM> and/or a fifth surface-area-to-volume ratio of the fifth groove <NUM>. In some embodiments, the first groove <NUM> has a greater volume than the fourth groove <NUM> and the fifth groove <NUM>. In some embodiments, the fourth groove <NUM> and the fifth groove <NUM> may be disposed on opposing sides of the first groove <NUM> and outwardly from the second groove <NUM> and the third groove <NUM>. In some embodiments, the fourth groove <NUM> and the fifth groove <NUM> may be disposed on opposing sides of the first groove <NUM> and/or may be symmetric about the first groove <NUM>. In further detail, in some embodiments, a shape of the fourth groove <NUM> may be a mirror image of a shape of the fifth groove <NUM>. In some embodiments, a symmetric pattern of the fourth groove <NUM> and the fifth groove <NUM> may facilitate visualization of blood flashback despite gravity bias due to the user's grip technique.

In some embodiments, the second groove <NUM>, the third groove <NUM>, the fourth groove <NUM>, or the fifth groove <NUM> may include one or more pockets <NUM> extending generally perpendicular to a longitudinal axis of the plug <NUM> and spaced along a length of one or more of the second groove <NUM>, the third groove <NUM>, the fourth groove <NUM>, and the fifth groove <NUM>. In some embodiments, the pockets <NUM> may facilitate visualization to the user of how far blood flashback has travelled.

In some embodiments, one or more of the grooves may be spaced apart by a capillary effect gap <NUM>, which may pull blood flashback quickly due to the capillary effect. In some embodiments, the capillary effect gap <NUM> and/or one or more other portions of the plug <NUM>, such as the grooves, may be constructed of a hydrophilic material. In some embodiments, the first groove <NUM> and the second groove <NUM> and/or the first groove <NUM> and the third groove <NUM> may be spaced apart by the capillary effect gap <NUM>. In some embodiments, a volume of the capillary effect gap <NUM> may be less than one or more of the following: the first groove <NUM>, the second groove <NUM>, the third groove <NUM>, the fourth groove <NUM>, and the fifth groove <NUM>. In some embodiments, the capillary effect gap <NUM> may be filled by blood flashback prior to one or more of the following: the first groove <NUM>, the second groove <NUM>, the third groove <NUM>, the fourth groove <NUM>, and the fifth groove <NUM>.

In some embodiments, each of the first groove <NUM>, the second groove <NUM>, the third groove <NUM>, the fourth groove <NUM>, and the fifth groove <NUM> may be vented and a proximal end of the second groove <NUM> may be vented. In these embodiments, the plug <NUM> may include the vents <NUM>. In some embodiments, the plug <NUM> may be constructed of plastic or another suitable material.

Claim 1:
A catheter system (<NUM>), comprising:
a catheter assembly (<NUM>), comprising:
a catheter adapter (<NUM>), comprising a lumen (<NUM>) extending through the catheter adapter;
a catheter (<NUM>) extending distally from the catheter adapter ; and
a needle assembly (<NUM>) coupled to the catheter assembly, the needle assembly comprising:
a plug (<NUM>), wherein an outer surface of the plug comprises a first groove (<NUM>) having a first surface-area-to-volume ratio and a second groove (<NUM>) having a second surface-area-to-volume ratio, wherein the first surface-area-to-volume ratio is less than the second surface-area-to-volume ratio, wherein the first groove has a greater volume than the second groove;
an outer housing (<NUM>), wherein the outer housing seals a top of the first groove and a top of the second groove to prevent blood from flowing out the top of the first groove and the top of the second groove; and
an introducer needle (<NUM>), comprising a distal end (<NUM>) and a proximal end (<NUM>), wherein the proximal end of the introducer needle is in fluid communication with the first groove and the second groove.