Patent Description:
A common type catheter is an over-the-needle catheter. As its name implies, a catheter that is "over-the-needle" may be mounted over an introducer needle having a sharp distal tip. The sharp distal tip may be used to pierce skin and a vein of a patient. Insertion of the catheter into the vein may follow the piercing of the vein by the introducer needle. The introducer needle typically has the sharp distal tip to pierce skin and the vein of the patient with minimal resistance to minimize the pain to the patient.

The introducer needle is generally placed at a steep inclined angle with respect to a surface of the skin and a longitudinal dimension of the vein to be pierced to allow penetration through the skin and a wall of the vein. The needle and the catheter are generally inserted with a bevel of the introducer needle facing away from the skin of the patient. After the tip of the introducer needle pierces the wall, the angle of the insertion is lowered to be able to slide the introducer needle and the catheter into the vein a distance sufficient to properly position the catheter in the vein. Once placement of the introducer needle within the vein has been confirmed, the user may temporarily occlude flow in the vein and withdraw the introducer needle, leaving the catheter in place for future fluid infusion and/or blood withdrawal.

Documents <CIT> and <CIT> disclose catheter adapters with divider in the side port. Documents <CIT> and <CIT> disclose catheter adapter with valves.

In this specifications the following non-SI units are used, which may be converted to the respective SI or metric unit according to the following conversion table:.

The present invention is disclosed in independent claim <NUM>. All methods of use, describe in the description, do not form a part of the invention, but can be used for explanatory reasons.

The present disclosure relates generally to a catheter assembly that may be used for power injection, as well as related devices, systems, and methods. "Power injection" may refer to infusion of large amounts of fluid in a short period of time. In some embodiments, a catheter assembly of the present disclosure may facilitate high flow rates and maintenance of a high pressure within a catheter adapter of the catheter assembly while also maintaining an integrity of a valve disposed within the catheter adapter. In some embodiments, the catheter assembly may increase a breaking threshold (i.e. burst value) of the valve, allowing fluid to be infused into the catheter adapter at high pressures.

The catheter adapter includes a body, which includes a distal end, a proximal end, and a first lumen extending through the distal end and the proximal end. A side port of the catheter adapter extends outwardly from the body and may be disposed between the distal end and the proximal end. The side port includes a second lumen perpendicular to the first lumen.

The catheter assembly includes a catheter, which may extend distally from the distal end of the body. The catheter assembly includes a valve disposed within the first lumen. The valve seals the first lumen from the second lumen. An outer surface of the valve is cylindrical.

In the present invention, the catheter assembly includes a divider, which may be disposed with the second lumen. In some embodiments, the catheter adapter and the divider may be monolithically formed as a single unit. In some embodiments, the divider may divide the second lumen into multiple openings. In some embodiments, the divider may be proximate the first lumen. In some embodiments, the divider may contact the valve. In some embodiments, the divider may be symmetrical. In some embodiments, one or more of the multiple openings may be identical. In some embodiments, the divider may include various shapes and patterns.

In some embodiments, the catheter adapter may include an inner surface, which may form the second lumen. In some embodiments, outer edges of the plurality of openings may form or be aligned with a shape, which may be symmetrical. In some embodiments, the divider may be linear and may extend from one side of the shape to another side of the shape. In some embodiments, the divider may be perpendicular to a longitudinal axis of the catheter adapter. In some embodiments, the divider may be parallel to the longitudinal axis of the catheter adapter.

In some embodiments, the divider may include multiple arms, which may extend from the shape to a central axis of the second lumen. In some embodiments, the divider may include X-shape. In these embodiments, the multiple arms may include a first arm, a second arm, a third arm, and a fourth arm. In some embodiments, two of the first arm, the second arm, the third arm, and the fourth arm may be parallel to the longitudinal axis of the catheter adapter. In some embodiments, the first arm, the second arm, the third arm, and the fourth arm may be offset from the longitudinal axis of the catheter adapter.

In some embodiments, the divider may include a Y-shape. In these embodiments, the multiple arms may include the first arm, the second arm, and the third arm. In some embodiments, one of the first arm, the second arm, and the third arm may be parallel to the longitudinal axis of the catheter adapter and may point distally. In some embodiments, one of the first arm, the second arm, and the third arm may be parallel to the longitudinal axis of the catheter adapter and may point proximally.

In some embodiments, a method of delivering fluid into the catheter adapter may include coupling a power injection device to the side port of the catheter adapter. In some embodiments, the method may include delivering fluid, via the power injection device, into the side port at a pressure. In some embodiments, an integrity of the valve may be maintained in response to delivering the fluid into the side port at the pressure. In some embodiments, the pressure may not exceed a burst value of the valve.

In some embodiments, the pressure may be greater than <NUM> psi. In some embodiments, the pressure may be between <NUM> psi and <NUM> psi. In some embodiments, the pressure may be between <NUM> psi and <NUM> psi. In some embodiments, the pressure may be between <NUM> psi and <NUM> psi. In some embodiments, the pressure may be between <NUM> psi and <NUM> psi. In some embodiments, the pressure may be between <NUM> psi and <NUM> psi. In some embodiments, the pressure may be between <NUM> psi and <NUM> psi, between <NUM> psi and <NUM> psi, between <NUM> psi and <NUM> psi, between <NUM> psi and <NUM> psi, between <NUM> psi and <NUM> psi, or between <NUM> psi and <NUM> psi. In some embodiments, in response to delivering the fluid into the side port at the pressure, the divider may inhibit expansion of the valve and/or shifting of the valve in a proximal direction and a distal direction.

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.

Referring now to <FIG>, a prior art catheter assembly <NUM> is illustrated. The prior art catheter assembly <NUM> may correspond to the BD VENFLON™ Pro Safety Shielded IV Catheter or another catheter assembly. The prior art catheter assembly <NUM> includes a catheter adapter <NUM> and a catheter <NUM> extending distally from the catheter adapter <NUM>. The catheter adapter <NUM> includes a body <NUM>, which 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 adapter <NUM> includes a side port <NUM> extending outwardly from the body <NUM> and may be covered by a removable cap <NUM>. A valve <NUM> is disposed in the lumen <NUM> and seals the side port <NUM> from the lumen <NUM>.

The prior art catheter assembly <NUM> may be unable to withstand the pressure that is delivered by a power injection device <NUM> coupled to the side port <NUM>, which may be used for power injection. The minimum pressure required for power injection, according to ISO <NUM>-<NUM>, is <NUM> psi. However, it has been shown that even pressures below <NUM> psi may exceed the burst value of the valve <NUM> in the prior art catheter assembly <NUM>, resulting in a rupture or break <NUM> of the valve <NUM>, as illustrated, for example, in <FIG>. The valve <NUM> may be the weakest component of the prior art catheter assembly <NUM>.

Further, the valve <NUM> may shift in a distal direction or a proximal direction in response to power injection. Referring now to <FIG>, in response to the power injection device <NUM> delivering the fluid at a high pressure, such as above <NUM> psi, the fluid may flow between an inner surface of the catheter adapter <NUM> and an outer surface of the valve <NUM> in a manner that shifts the valve <NUM> from its original position, illustrated in <FIG>, to a distal position, illustrated in <FIG>, or a proximal position. Thus, the valve <NUM> may be prevented from resealing the side port <NUM> from the lumen <NUM> after completion of the power injection and may no longer be functional.

In some embodiments, the prior art catheter assembly <NUM> may be removably coupled to a prior art needle assembly <NUM>, which may include a needle hub <NUM> and an introducer needle <NUM>. In some embodiments, the introducer needle <NUM> may include a sharp distal tip <NUM>. In some embodiments, a proximal end of the introducer needle <NUM> may be secured within the needle hub <NUM>. In some embodiments, the introducer needle <NUM> may extend through the catheter <NUM> when the prior art catheter assembly <NUM> is in an insertion position ready for insertion into vasculature of a patient, as illustrated, for example, in <FIG>.

In some embodiments, in response to the introducer needle <NUM> being inserted into the vasculature of the patient, flashback of blood may flow through the sharp distal tip <NUM> of the introducer needle <NUM> and may be visible to a clinician between the introducer needle <NUM> and the catheter <NUM> and/or at another location within the prior art catheter assembly <NUM>.

In some embodiments, in response to confirmation via the blood flashback that the catheter <NUM> is positioned within vasculature of the patient, the prior art needle assembly <NUM> may be removed from the prior art catheter assembly <NUM>, as illustrated in <FIG>. In some embodiments, when the prior art needle assembly <NUM> is coupled to the prior art catheter assembly <NUM>, as illustrated, for example, in <FIG>, the introducer needle <NUM> of the prior art needle assembly <NUM> may extend through the valve <NUM> disposed within the lumen <NUM> of the catheter adapter <NUM>.

Referring now to <FIG>, a catheter assembly <NUM> is illustrated, according to some embodiments. In some embodiments, the catheter assembly <NUM> may include or correspond to the prior art catheter assembly <NUM>. For example, one or more components of the catheter assembly <NUM> may include or correspond to one or more components of the prior art catheter assembly <NUM>.

In some embodiments, the catheter assembly <NUM> may include a catheter adapter <NUM>. In some embodiments, the catheter adapter <NUM> may include a body <NUM>, which may include a distal end <NUM>, a proximal end <NUM>, and a first lumen <NUM> extending through the distal end <NUM> and the proximal end <NUM>. In some embodiments, the catheter adapter <NUM> may include a side port <NUM> extending outwardly from the body <NUM>. In some embodiments, the side port <NUM> may be disposed between the distal end <NUM> and the proximal end <NUM>. In some embodiments, the side port <NUM> may include a second lumen <NUM>, which may be perpendicular to the first lumen <NUM>. In some embodiments, the second lumen <NUM> may extend through the side port <NUM> to the first lumen <NUM>. In some embodiments, the first lumen <NUM> may be generally cylindrical, and the second lumen <NUM> may be generally cylindrical.

In some embodiments, the catheter assembly <NUM> may include a catheter <NUM>, which may extend distally from the distal end <NUM> of the body <NUM> and may be secured within the catheter adapter <NUM>. In some embodiments, the catheter assembly <NUM> may include a valve <NUM> disposed within the first lumen <NUM>. In some embodiments, the valve <NUM> may seal the first lumen <NUM> from the second lumen <NUM>, preventing fluid from travelling between the first lumen <NUM> and the second lumen <NUM>. In some embodiments, an outer surface of the valve <NUM> may be cylindrical. In some embodiments, the valve <NUM> may be solid. In other embodiments, the valve <NUM> may include an opening extending through a distal end of the valve <NUM> and a proximal end of the valve <NUM>. In some embodiments, the valve <NUM> may be constructed of silicon or another suitable material.

In some embodiments, the catheter assembly <NUM> may include a divider <NUM>, which may be disposed within the second lumen <NUM>. In some embodiments, the catheter adapter <NUM> and the divider <NUM> may be monolithically formed as a single unit, which may secure the divider <NUM> in response to power injection through the side port <NUM>. In some embodiments, the divider <NUM> may divide the second lumen <NUM> into multiple openings <NUM>. In some embodiments, the divider <NUM> may be constructed of plastic, metal, or another suitable material. In some embodiments, the divider <NUM> may be rigid.

In some embodiments, the divider <NUM> may be proximate the first lumen <NUM>. In some embodiments, the divider may be disposed between an outer surface <NUM> of the body <NUM> and an inner surface <NUM> of the body <NUM> forming the first lumen <NUM>. In some embodiments, the divider <NUM> may be disposed between the side port <NUM> and the inner surface <NUM> of the body <NUM>. In some embodiments, the divider <NUM> may be disposed within the side port <NUM> or a portion of the second lumen <NUM> disposed within the side port <NUM>.

In some embodiments, the divider <NUM> may contact the valve <NUM>. In some embodiments, the divider <NUM> may be symmetrical, which may provide an evenly distributed amount of pressure on the valve <NUM> during power injection. In some embodiments, the divider <NUM> may be asymmetrical. In some embodiments, one or more of the multiple openings <NUM> may be identical. In some embodiments, the divider <NUM> may include various shapes and patterns.

In some embodiments, the divider <NUM> may facilitate high flow rates and maintenance of a high pressure within the catheter adapter <NUM> while also maintaining the integrity of the valve <NUM>. In some embodiments, the divider <NUM> may increase a burst value of the valve <NUM> such that the valve <NUM> is able to withstand high pressure during power injection into the catheter adapter <NUM> without breaking. Thus, in some embodiments, the valve <NUM> may include a multi-use valve usable for multiple power injections.

In some embodiments, in response to delivering the fluid into the side port <NUM> at a pressure during power injection, the divider <NUM> may reduce or eliminate expansion of the valve <NUM> as the valve <NUM> contacts and presses upon the divider <NUM>. In some embodiments, in response to delivering the fluid into the side port <NUM> at the pressure during power injection, the divider <NUM> may reduce or eliminate shifting of the valve <NUM> in a proximal direction and a distal direction.

In some embodiments, the pressure may be greater than <NUM> psi. In some embodiments, the pressure may be between <NUM> psi and <NUM> psi. In some embodiments, the pressure may be between <NUM> psi and <NUM> psi. In some embodiments, the pressure may be between <NUM> psi and <NUM> psi. In some embodiments, the pressure may be between <NUM> psi and <NUM> psi. In some embodiments, the pressure may be between <NUM> psi and <NUM> psi. In some embodiments, the pressure may be between <NUM> psi and <NUM> psi, between <NUM> psi and <NUM> psi, between <NUM> psi and <NUM> psi, between <NUM> psi and <NUM> psi, between <NUM> psi and <NUM> psi, or between <NUM> psi and <NUM> psi. In some embodiments, in response to delivering the fluid into the side port <NUM> at the pressure, the divider <NUM> may inhibit expansion of the valve <NUM> and/or shifting of the valve <NUM> in the proximal direction and the distal direction. In some embodiments, the multiple openings <NUM> may be configured to allow fluid to flow from the side port <NUM> to the body <NUM> at a flow rate of between about <NUM> and <NUM> per second and/or at the pressure. In some embodiments, the multiple openings <NUM> may be configured to allow fluid to flow from the side port <NUM> to the body <NUM> at another suitable flow rate.

In some embodiments, the burst value of the valve <NUM> may be greater than <NUM> psi. In some embodiments, the burst value of the valve <NUM> may be between <NUM> psi and <NUM> psi. In some embodiments, the burst value of the valve <NUM> may be between <NUM> psi and <NUM> psi. In some embodiments, the burst value of the valve <NUM> may be between <NUM> psi and <NUM> psi. In some embodiments, the burst value of the valve <NUM> may be between <NUM> psi and <NUM> psi. In some embodiments, the burst value of the valve <NUM> may be between <NUM> psi and <NUM> psi. In some embodiments, the burst value of the valve <NUM> may be between <NUM> psi and <NUM> psi, between <NUM> psi and <NUM> psi, between <NUM> psi and <NUM> psi, between <NUM> psi and <NUM> psi, between <NUM> psi and <NUM> psi, or between <NUM> psi and <NUM> psi. In some embodiments, the valve <NUM> may be stronger than body <NUM>, which may rupture or break at a lower pressure than the valve <NUM>.

Referring now to <FIG>, in some embodiments, the catheter adapter <NUM> may include another inner surface <NUM>, which may form the second lumen <NUM>. In some embodiments, outer edges <NUM> of the multiple openings <NUM> may form or be aligned with a shape <NUM> which may be an ellipse or a geometric shape, such as a circle or triangle. In some embodiments, the shape <NUM> may be symmetric. In some embodiments, the outer edges <NUM> may include arcs, which may connect two lines forming inner edges of the multiple openings <NUM> or ends of a single line forming an inner edge of the multiple openings <NUM>. In some embodiments, the two lines may intersect at a corner or a rounded edge.

In some embodiments, a diameter of the shape <NUM>, which may include a maximum diameter of the shape <NUM>, may be less than a diameter of a portion of the other inner surface <NUM> that is proximate the shape <NUM> and closer to an outer opening <NUM> of the side port <NUM>, as illustrated, for example, in <FIG>. Thus, in some embodiments, the second lumen <NUM> may be stepped and the divider <NUM> may extend from a stepped surface. In other embodiments, the diameter of the shape <NUM> may be equal to the diameter of the portion of the other inner surface <NUM> that is proximate the shape <NUM> and closer to an outer opening <NUM> of the side port <NUM>. In these embodiments, the divider <NUM> may not extend from a stepped surface.

In some embodiments, the divider <NUM> may include multiple arms <NUM>, which may extend from the shape <NUM> to a central axis <NUM> (see also <FIG>) of the second lumen <NUM>. In some embodiments, the divider <NUM> may include X-shape. In these embodiments, the multiple arms <NUM> may include a first arm 70a, a second arm 70b, a third arm 70c, and a fourth arm 70d. In some embodiments, two of the first arm 70a, the second arm 70b, the third arm 70c, and the fourth arm 70d may be parallel to a longitudinal axis <NUM> (see also <FIG>) of the catheter adapter <NUM>, as illustrated in <FIG>. As illustrated in <FIG>, in some embodiments, the first arm 70a, the second arm 70b, the third arm 70c, and the fourth arm 70d may be offset from the longitudinal axis <NUM> of the catheter adapter <NUM>, such as, for example, by about <NUM>° or another suitable angle.

Referring now to <FIG>, in some embodiments, the divider <NUM> may include a Y-shape. In these embodiments, the multiple arms <NUM> may include the first arm 70a, the second arm 70b, and the third arm 70c. In some embodiments, one of the first arm 70a, the second arm 70b, and the third arm 70c may be parallel to the longitudinal axis <NUM> of the catheter adapter <NUM> and may point distally, as illustrated in <FIG>. As illustrated in <FIG>, in some embodiments, one of the first arm 70a, the second arm 70b, and the third arm 70c may be parallel to the longitudinal axis <NUM> of the catheter adapter <NUM> and may point proximally. In some embodiments, none of the first arm 70a, the second arm 70b, or the third arm 70c may be aligned with the longitudinal axis <NUM> of the catheter adapter <NUM>.

Referring now to <FIG>, in some embodiments, the divider <NUM> may be linear and may extend from one side of the shape <NUM> to another side of the shape <NUM>. In some embodiments, the divider <NUM> that is linear and/or oriented perpendicular to the longitudinal axis <NUM> of the catheter adapter <NUM> may reduce leakage of fluid between the outer surface of the valve <NUM> and the inner surface <NUM> of the body <NUM> that might otherwise shift the valve <NUM> in the proximal direction or the distal direction during power injection. In some embodiments, the divider <NUM> may be perpendicular to the longitudinal axis <NUM> of the catheter adapter <NUM>, as illustrated in <FIG>. In some embodiments, the divider <NUM> may be parallel to the longitudinal axis <NUM> of the catheter adapter <NUM>, as illustrated in <FIG>.

In some embodiments, a method of delivering fluid into the catheter adapter <NUM> may include coupling the power injection device <NUM> to the side port <NUM> of the catheter adapter <NUM>. In some embodiments, the method may include delivering fluid, via the power injection device <NUM>, into the side port <NUM> at the pressure. In some embodiments, an integrity of the valve <NUM> may be maintained in response to delivering the fluid into the side port <NUM> at the pressure. In some embodiments, the pressure may not exceed the burst value of the valve <NUM>.

Claim 1:
A catheter assembly (<NUM>), comprising:
a catheter adapter (<NUM>), comprising:
a body (<NUM>), comprising a distal end (<NUM>), a proximal end (<NUM>), and a first lumen (<NUM>) extending through the distal end and the proximal end;
a side port (<NUM>) extending outwardly from the body and disposed between the distal end and the proximal end, wherein the side port comprises a second lumen (<NUM>) perpendicular to the first lumen;
a catheter (<NUM>) extending distally from the distal end of the body;
a valve (<NUM>) disposed within the first lumen and sealing the first lumen from the second lumen, wherein an outer surface of the valve is cylindrical; and
a divider (<NUM>) disposed with the second lumen, wherein the divider divides the second lumen into a plurality of openings (<NUM>).