Patent Description:
A common type of IV catheter is an over-the-needle peripheral IV catheter. As its name implies, the over-the-needle peripheral IV catheter may be mounted over an introducer needle having a sharp distal tip. The sharp distal tip may be used to pierce skin and a vasculature of the patient. Insertion of the IV catheter into the vasculature may follow the piercing of the vasculature by the introducer needle. The introducer needle and the IV catheter are generally inserted at a shallow angle through the skin into the vasculature of the patient with a bevel of the introducer needle facing away from the skin of the patient.

In order to verify proper placement of the introducer needle and/or the IV catheter in the vasculature, a clinician generally confirms that there is flashback of blood, which may be visible to the clinician. In some instances, the introducer needle may include a single notch, 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 another device (e.g., the IV catheter). Accordingly, where the other device is at least partially transparent, the clinician may visualize a small amount of blood "flashback" and thereby confirm placement of the catheter within the vasculature. Presence of a vasculature entrance indicator, such as flashback, may facilitate successful placement of IV catheters. Once placement of the introducer needle within the vasculature has been confirmed, the clinician may temporarily occlude flow in the vasculature and withdraw the introducer needle, leaving the catheter in place for future blood withdrawal and/or fluid infusion.

In some markets, priming of the IV catheter is common practice. In order to prime the IV catheter, the clinician may fill the IV catheter with saline or another priming fluid to reduce or eliminate any air pockets disposed within the IV catheter. The saline may also fill a portion of a needle lumen proximate the notch, as well as distal to the notch, all the way to the distal tip of the introducer needle. Thus, when the distal tip of the introducer needle enters the vasculature, flashback may be slowed due to diffusion. Flashback may also be difficult to visualize due to mixing of flashback with the saline.

Furthermore, many integrated IV catheter systems having an integrated extension tube do not include a flash chamber, which may be vented. Examples of integrated IV catheter systems may include, for example, the BD NEXIVA™ Closed IV Catheter System, the BD NEXIVA™ DIFFUSICS™ Closed IV Catheter System, or the Becton Dickinson PEGASUS™ Safety Closed IV Catheter System. Thus, after the priming of the IV catheter, the IV catheter system may no longer be vented, and when the distal tip of the introducer needle enters the vasculature, blood may only slowly diffuse into the introducer needle. Also, transfixation of the vasculature may not be observed since the proximal diffusion of the blood may continue even when the distal tip is no longer properly placed within the vasculature.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are not restrictive of the invention, as claimed. <CIT> discloses a multiple cross section needle and elastic plug assembly for a medical device. <CIT> discloses a compliant catheter adapter having a self-slitting needle. <CIT> discloses a vascular access device. <CIT> discloses a catheter introduction device. <CIT>discloses an autoinjector with mixing means. The subject matter of the invention is defined by the appended claims.

The present disclosure relates generally to an introducer needle having a first notch and a second notch, and related devices, systems, and methods (no methods are claimed). The introducer needle includes a proximal end, a distal tip, and a needle lumen extending between the proximal end and the distal tip. The introducer needle includes a wall, which defines the needle lumen. The first notch is formed through the wall, and the second notch is formed through the wall. The second notch is proximal to the first notch.

The catheter system includes a catheter adapter, which includes a distal end, a proximal end, and a lumen extending between the distal end and the proximal end. The catheter system includes a catheter, which may include an IV catheter, such as a peripheral IV catheter, for example. The catheter extends distally from the distal end of the catheter adapter. The catheter system includes the introducer needle, which may extend through the catheter and beyond the distal end of the catheter when the introducer needle is in an insertion position for insertion into vasculature of a patient.

The first notch of the introducer needle is disposed within the catheter when the introducer needle is in the insertion position. At least a portion of the catheter is transparent. In some embodiments, where the proximal end of the introducer needle is vented such that air and/or fluid may travel proximally through the introducer needle, presence of the first and second notches may facilitate pressure-driven blood flow into the catheter for improved flashback and detection of transfixation. In some embodiments, the first and second notches may improve first needle stick success by improving the quality of flashback.

In further detail, in some embodiments, the catheter system may include a first fluid pathway, which may extend from the first notch to the second notch between an outer surface of the introducer needle and an inner surface of a wall of the catheter, and a second fluid pathway, which may extend from the first notch to the second notch within the needle lumen. During flashback, blood may flow through the first fluid pathway and/or the second fluid pathway. In some embodiments, the first fluid pathway may provide pressure-driven flashback, even after the catheter system is primed. In some embodiments, flashback may be faster through the first fluid pathway than the second fluid pathway. In some embodiments, flashback through the first fluid pathway may be visible due to the transparency of the catheter.

In some embodiments, the first fluid pathway may have a larger volume than the second fluid pathway, which may facilitate faster flashback through the first fluid pathway than the second fluid pathway. In some embodiments, a cross-section taken through the catheter system perpendicular to a central axis of the catheter system and between the first notch and the second notch may include a needle lumen area and another area between the outer surface of the introducer needle and the inner surface of the wall of the catheter. In some embodiments, the other area may be greater than the needle lumen area. In some embodiments, the other area may be greater than the needle lumen area in each cross-section taken through the catheter system perpendicular to the central axis along an entire length between the first notch and the second notch.

In some embodiments, the catheter system may include a flash chamber, which may facilitate flashback. In some embodiments, the flash chamber may be in fluid communication with the needle lumen. In some embodiments, the flash chamber may include a gas permeable vent. In some embodiments, the gas permeable vent of the flash chamber may provide the venting that allows air and/or fluid to travel proximally through the introducer needle. In some embodiments, the flash chamber may be disposed proximal to the proximal end of the introducer needle. In some embodiments, the gas permeable vent may provide at least some resistance to air flow.

In some embodiments, the catheter may be primed prior to insertion of the catheter and introducer needle into the vasculature of the patient. In some embodiments, the catheter may be primed when the introducer needle is in the insertion position. In some embodiments, in order to prime the catheter, the user may fill the catheter with a priming fluid, such as, for example, saline, to reduce or eliminate any air pockets disposed within the catheter. In some embodiments, the priming fluid may be disposed in a first portion of a needle lumen proximate the first notch and including the distal tip of the introducer needle. Additionally, in some embodiments, the priming fluid may be disposed in a second portion of the needle lumen proximate the second notch. In some embodiments, when the gas permeable vent provides the resistance, the priming fluid in the first portion may be separated from the priming fluid in the second portion, and air may be disposed between the first portion and the second portion in the needle lumen.

In some embodiments, in response to the distal tip of the introducer needle entering the vasculature, blood pressure will drive the flashback into the needle. Additionally, in some embodiments, at least some of the flashback may then be driven out of the introducer needle at the first notch and into the catheter. Furthermore, in some embodiments, in response to the distal tip of the introducer needle entering the vasculature, the priming fluid outside the introducer needle and within the catheter tube between the first notch and the second notch may be driven into the introducer needle through the second notch and may eventually reach the flash chamber. In some embodiments, in response to the distal tip of the introducer needle entering the vasculature, blood may flow proximally through the needle as well. In some embodiments, the pressure-driven blood flow through the first fluid pathway, which may initially be filled with the priming fluid, may be faster than diffusion.

In some embodiments, the flash chamber may include a large, non-restrictive volume, which may facilitate the pressure-driven flow of the priming fluid and/or blood towards or into the flash chamber. In some embodiments, a volume of the flash chamber may be large enough to hold the priming fluid disposed outside the introducer needle and within the catheter between the first notch and the second notch and/or the priming fluid that may travel into the flash chamber during priming of the catheter. Additionally, in some embodiments, the volume of the flash chamber may be large enough to hold blood when the distal tip of the introducer needle is disposed within the vasculature.

A portion of the wall of the introducer needle between the first notch and the second notch is pinched or crimped such that fluid, such as blood, is prevented from flowing in the needle lumen between the first notch and the second notch. In some embodiments, the crimped portion of the wall may facilitate rapid flashback through the first fluid pathway.

The second notch is disposed within the catheter when the needle is in the insertion position. The second notch is In some embodiments, the second notch may be disposed within the lumen of the catheter adapter when the needle is in the insertion position. In some embodiments, a distance between the first notch and the second notch may be greater than a length of the catheter, which may facilitate visibility of transfixation.

In some embodiments, the catheter system may include a needle hub, which may be coupled to the catheter adapter when the introducer needle is in the insertion position. In some embodiments, a proximal end of the introducer needle may be secured within the needle hub. In some embodiments, the flash chamber may be disposed within the needle hub.

The catheter system includes a blood control septum, which is disposed within the lumen of the catheter adapter. The septum divides the lumen of the catheter adapter into a proximal chamber and a distal chamber. The second notch is disposed distal to the septum when the introducer needle is in the insertion position.

In some embodiments, the catheter adapter may include a gas permeable vent, which may be selectively opened and/or closed. In some embodiments, the gas permeable vent of the catheter adapter may be disposed distal to the septum such that air in the distal chamber may freely flow out of the gas permeable vent when the vent is opened. In some embodiments, the gas permeable vent of the catheter adapter may be opened during priming of the catheter, which may prevent the priming fluid from being disposed in the first portion of the needle proximate the first notch and/or the second portion of the needle proximate the second notch, as the gas permeable vent of the catheter adapter may provide a path of low resistance for the priming fluid.

In some embodiments, the catheter system may include a seal, which may be secured within the lumen of the catheter adapter. In these and other embodiments, the portion of the wall of the introducer needle between the first notch and the second notch may be pinched or crimped such that fluid is prevented from flowing in the needle lumen between the first notch and the second notch. In some embodiments, the introducer needle may be rotatable from a priming position to the insertion position and/or from the insertion position to the priming position. In some embodiments, the introducer needle may be disposed in the priming position during priming of the catheter and may be disposed in the insertion position during insertion into the vasculature.

In some embodiments, when the introducer needle is in the priming position, the seal may cover and seal the second notch, which may prevent fluid from flowing through the second notch. In some embodiments, when the introducer needle is in the insertion position, the seal may not cover or seal the second notch and fluid may flow through the second notch. In some embodiments, in response to the second notch being uncovered or unsealed, rapid flashback may occur with blood flowing into the needle lumen via the second notch. In some embodiments, the seal may include a septum or flapper.

In some embodiments, the introducer needle may be rotatable between the priming position and the insertion position about the central axis of the catheter system, which may extend through the needle lumen. In some embodiments, the introducer needle may be rotated by twisting the needle hub. In some embodiments, the introducer needle may be rotated in a first direction and/or a second direction opposite the first direction. In some embodiments, the second notch may be aligned with the seal when the introducer needle is in the priming position and the insertion position. In these and other embodiments, the introducer needle may extend a same distance from the distal tip of the catheter when the introducer needle is in the priming position as when the introducer needle is in the insertion position.

In some embodiments, the catheter system may include a plug constructed of a dissolvable material. In some embodiments, the plug may be disposed on top of the second notch to seal the second notch during priming of the catheter system.

It is to be understood that both the foregoing general description and the following detailed description are exemplary 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.

The present disclosure relates generally to an introducer needle having a first notch and a second notch, and related devices, systems, and methods. Referring now to <FIG>, in some embodiments, a catheter system <NUM> may include a catheter adapter <NUM>, which may include a distal end, a proximal end, and a lumen extending between the distal end and the proximal end. The catheter system <NUM> includes a catheter <NUM>, which may include an IV catheter, such as a peripheral IV catheter, for example. The catheter <NUM> extends distally from the distal end of the catheter adapter <NUM>. The catheter system <NUM> includes the introducer needle <NUM>, which may extend through the catheter <NUM> and beyond the distal end of the catheter <NUM> when the introducer needle <NUM> is in an insertion position for insertion into vasculature of a patient.

In some embodiments, the catheter system <NUM> may include a needle hub <NUM>, which may be coupled to the catheter adapter <NUM> when the introducer needle <NUM> is in the insertion position. In some embodiments, a proximal end of the introducer needle <NUM> may be secured within the needle hub <NUM>. In some embodiments, the catheter system <NUM> may include a needle shield <NUM>. In some embodiments, the catheter system <NUM> may be integrated or non-integrated. In some embodiments, the catheter system <NUM> may include the needle shield <NUM> or any other type of suitable needle safety mechanism.

Referring now to <FIG>, the introducer needle <NUM> includes a proximal end, a distal tip <NUM>, and a needle lumen <NUM> extending between the proximal end and the distal tip <NUM>. The introducer needle <NUM> includes a wall <NUM>, which may define the needle lumen <NUM>. The first notch <NUM> is formed through the wall <NUM>, and the second notch <NUM> is formed through the wall <NUM>. The second notch <NUM> is proximal to the first notch <NUM>. In some embodiments, the wall <NUM> may include more than two notches.

The first notch <NUM> of the introducer needle <NUM> is disposed within the catheter <NUM> when the introducer needle <NUM> is in the insertion position. At least a portion of the catheter <NUM> is transparent. In some embodiments, presence of the second notch <NUM> may facilitate pressure-driven blood flow into the catheter <NUM> for improved flashback and detection of transfixation. In some embodiments, the second notch <NUM> may improve first needle stick success by improving the quality of flashback.

In further detail, in some embodiments, the catheter system <NUM> may include a first fluid pathway <NUM>, which may extend from the first notch <NUM> to the second notch <NUM> between an outer surface of the introducer needle <NUM> and an inner surface of a wall <NUM> forming the catheter <NUM>, and a second fluid pathway <NUM>, which may extend from the first notch <NUM> to the second notch <NUM> within the needle lumen <NUM>. In some embodiments, during flashback, blood may flow through the first fluid pathway <NUM> and/or the second fluid pathway <NUM>. In some embodiments, the first fluid pathway <NUM> may provide pressure-driven flashback, even after the catheter system <NUM> is primed. In some embodiments, flashback or proximal blood travel may be faster through the first fluid pathway <NUM> than the second fluid pathway <NUM>. In some embodiments, flashback through the first fluid pathway <NUM> may be visible due to the transparency of the catheter <NUM>.

The second notch <NUM> is disposed within the catheter <NUM> when the introducer needle <NUM> is in the insertion position. The second notch <NUM> is disposed within the lumen of the catheter adapter (as illustrated, for example, in <FIG>) when the introducer needle <NUM> is in the insertion position. In some embodiments, a distance between the first notch <NUM> and the second notch <NUM> may be greater than a length of the catheter <NUM>, which may facilitate visibility of transfixation.

In some embodiments, the first fluid pathway <NUM> may have a larger volume than the second fluid pathway <NUM>, which may facilitate faster flashback or proximal blood travel through the first fluid pathway <NUM> than the second fluid pathway <NUM>. Referring now to <FIG>, in some embodiments, a cross-section taken through the catheter system <NUM> perpendicular to a central axis <NUM> of the catheter system <NUM> and between the first notch <NUM> and the second notch <NUM> may include a needle lumen area <NUM> and another area <NUM> between the outer surface of the introducer needle <NUM> and the inner surface of the wall <NUM> of the catheter <NUM>. In some embodiments, the other area <NUM> may be greater than the needle lumen area <NUM>. In some embodiments, the other area <NUM> may be greater than the needle lumen area <NUM> in each cross-section taken through the catheter system <NUM> perpendicular to the central axis <NUM> along an entire length between the first notch <NUM> and the second notch <NUM>.

Referring now to <FIG>, a in some embodiments, a portion of the wall <NUM> of the introducer needle <NUM> between the first notch <NUM> and the second notch <NUM> is pinched or crimped such that fluid, such as blood, is prevented from flowing in the needle lumen <NUM> between the first notch <NUM> and the second notch <NUM>. In some embodiments, the crimped portion <NUM> of the wall <NUM> may facilitate rapid flashback through the first fluid pathway <NUM>.

Referring now to <FIG>, in some embodiments, a plug <NUM>, which may be constructed of a dissolvable material, may seal the second notch <NUM> during priming of the catheter <NUM>. In some embodiments, the plug <NUM> may be dissolved when the catheter system <NUM> is introduced into the vasculature of the patient.

Referring now to <FIG>, in some embodiments, a sleeve <NUM>, which may be constructed of a dissolvable material, may seal the second notch <NUM> during priming of the catheter <NUM>. In some embodiments, the sleeve <NUM> may be dissolved when the catheter system <NUM> is introduced into the vasculature of the patient.

Referring now to <FIG>, in some embodiments, the catheter system <NUM> may include a flash chamber <NUM>, which may facilitate flashback. In some embodiments, the flash chamber <NUM> may be in fluid communication with the needle lumen <NUM>. In some embodiments, the flash chamber <NUM> may include a gas permeable vent <NUM>. In some embodiments, the flash chamber <NUM> may be disposed proximal to the proximal end <NUM> of the introducer needle <NUM>. In some embodiments, the gas permeable vent <NUM> may provide at least some resistance to air flow. In some embodiments, the flash chamber <NUM> may be disposed within the needle hub <NUM>, as illustrated, for example, in <FIG> illustrate a needle assembly with the needle shield <NUM> removed, according to some embodiments.

In some embodiments, the catheter <NUM> may be primed prior to insertion of the catheter <NUM> and the introducer needle <NUM> into the vasculature of the patient. In some embodiments, the catheter <NUM> may be primed when the introducer needle <NUM> is in the insertion position. In some embodiments, in order to prime the catheter <NUM>, the user may fill the catheter <NUM> with a priming fluid, such as, for example, saline, to reduce or eliminate any air pockets disposed within the catheter. In some embodiments, the priming fluid may be disposed in a first portion of a needle lumen proximate the first notch <NUM> and including the distal tip <NUM> of the introducer needle <NUM>. Additionally, in some embodiments, the priming fluid may be disposed in a second portion of the needle lumen <NUM> proximate the second notch <NUM>. In some embodiments, when the gas permeable vent <NUM> provides the resistance, the priming fluid in the first portion may be separated from the priming fluid in the second portion, and air may be disposed between the first portion and the second portion in the needle lumen <NUM>.

In some embodiments, in response to the distal tip <NUM> of the introducer needle <NUM> entering the vasculature, blood pressure will drive the flashback into the introducer needle <NUM>. Additionally, in some embodiments, at least some of the flashback may then be driven out of the introducer needle <NUM> at the first notch <NUM> and into the catheter <NUM>. Furthermore, in some embodiments, in response to the distal tip <NUM> of the introducer needle <NUM> entering the vasculature, the priming fluid outside the introducer needle <NUM> and within the catheter <NUM> between the first notch <NUM> and the second notch <NUM> may be driven into the introducer needle <NUM> through the second notch <NUM> and may eventually reach the flash chamber <NUM>. In some embodiments, in response to the distal tip <NUM> of the introducer needle16 entering the vasculature, blood may flow proximally through the introducer needle <NUM> as well. In some embodiments, the pressure-driven blood flow through the first fluid pathway <NUM>, which may initially be filled with the priming fluid, may be faster than diffusion.

In some embodiments, the flash chamber <NUM> may include a large, non-restrictive volume, which may facilitate the pressure-driven flow of the priming fluid and/or blood towards or into the flash chamber <NUM>. In some embodiments, a volume of the flash chamber <NUM> may be large enough to hold the priming fluid disposed outside the introducer needle <NUM> and within the catheter <NUM> between the first notch <NUM> and the second notch <NUM> and/or the priming fluid that may travel into the flash chamber <NUM> during priming of the catheter <NUM>. Additionally, in some embodiments, the volume of the flash chamber <NUM> may be large enough to hold blood when the distal tip <NUM> of the introducer needle <NUM> is disposed within the vasculature.

Referring now to <FIG>, the catheter system <NUM> includes a blood control septum <NUM>, which is disposed within the lumen <NUM> of the catheter adapter <NUM>. The septum <NUM> divides the lumen <NUM> of the catheter adapter <NUM> into a proximal chamber <NUM> and a distal chamber <NUM>. The second notch <NUM> is disposed distal to the septum <NUM> when the introducer needle <NUM> is in the insertion position.

In some embodiments, the catheter adapter <NUM> may include a gas permeable vent <NUM>, which may be selectively opened and/or closed. In some embodiments, the gas permeable vent <NUM>, which may be disposed through a wall of the catheter adapter <NUM>, may be disposed distal to the septum <NUM> such that air in the distal chamber <NUM> may freely flow out of the gas permeable vent <NUM> when the gas permeable vent <NUM> is opened. In some embodiments, the gas permeable vent <NUM> of the catheter adapter <NUM> may be opened during priming of the catheter <NUM>, which may prevent the priming fluid from being disposed in the first portion of the introducer needle <NUM> proximate the first notch <NUM> and/or the second portion <NUM> of the introducer needle <NUM> proximate the second notch <NUM>.

In some embodiments, the catheter system <NUM> may include a seal <NUM>, which may be secured within the lumen <NUM> of the catheter adapter <NUM>. In these and other embodiments, the portion of the wall of the introducer needle <NUM> between the first notch <NUM> and the second notch <NUM> may be pinched or crimped such that fluid is prevented from flowing in the needle lumen <NUM> between the first notch <NUM> and the second notch <NUM>. In some embodiments, the introducer needle <NUM> may be rotatable from a priming position to the insertion position and/or from the insertion position to the priming position. <FIG> illustrates the introducer needle <NUM> in the insertion position, according to some embodiments, and <FIG> illustrates the introducer needle <NUM> in the priming position, according to some embodiments. In some embodiments, the introducer needle <NUM> may be disposed in the priming position during priming of the catheter and may be disposed in the insertion position during insertion into the vasculature. In some embodiments, the catheter system <NUM> may not include the seal <NUM> and/or the priming and insertions positions may be the same.

In some embodiments, when the introducer needle <NUM> is in the priming position, the seal <NUM> may cover or seal the second notch, which may prevent fluid from flowing through the second notch <NUM>. In some embodiments, when the introducer needle <NUM> is in the insertion position, the seal <NUM> may not cover or seal the second notch <NUM> and fluid may flow through the second notch <NUM>. In some embodiments, in response to the second notch <NUM> being uncovered or the priming position and the insertion position, as illustrated in <FIG>, for example. In these and other embodiments, the introducer needle <NUM> may extend a same distance from the distal tip of the catheter <NUM> when the introducer needle <NUM> is in the priming position as when the introducer needle <NUM> is in the insertion position.

Claim 1:
A catheter system (<NUM>), comprising:
a catheter adapter (<NUM>), comprising a distal end, a proximal end, and a lumen (<NUM>) extending therebetween;
a catheter (<NUM>) extending distally from the distal end of the catheter adapter (<NUM>); and
a blood control septum (<NUM>) disposed within the lumen (<NUM>) and dividing the lumen (<NUM>) into a proximal chamber (<NUM>) and a distal chamber (<NUM>); and
an introducer needle (<NUM>) having a wall (<NUM>) defining a needle lumen (<NUM>) of the introducer needle (<NUM>), a first notch (<NUM>) formed through the wall (<NUM>), and a second notch (<NUM>) formed through the wall (<NUM>), wherein the second notch (<NUM>) is proximal to the first notch (<NUM>), wherein the introducer needle (<NUM>) extends through the catheter (<NUM>) and beyond the distal end of the catheter (<NUM>) when the introducer needle (<NUM>) is in an insertion position for insertion into a patient, wherein the first notch (<NUM>) is disposed within the catheter (<NUM>) when the introducer needle (<NUM>) is in the insertion position, wherein at least a portion of the catheter (<NUM>) is transparent, wherein the second notch (<NUM>) is disposed distal to the septum (<NUM>) when the introducer needle (<NUM>) is in an insertion position,
characterized in that
a portion of the wall (<NUM>) between the first notch (<NUM>) and the second notch (<NUM>) is crimped such that fluid is prevented from flowing in the needle lumen (<NUM>) between the first notch (<NUM>) and the second notch (<NUM>).