Patent Description:
Different types of medical devices, such as needles, introducers, trocars, catheters, stents, angiography balloons, cutting tools, and imaging tools can be introduced into the body for various medical procedures. For example, catheters are used to introduce or remove fluids from vessels in the body for a variety of medical procedures. In a typical procedure, to insert a catheter in a vessel, the vessel access is first verified by aspiration using a long hollow needle, such as a syringe needle. A guidewire is then passed through the needle into the vessel. The guidewire acts as a track for the catheter to pass over to reach a target location within the vessel. A catheter is finally passed over the guidewire to the target location in the vasculature of the patient. With the catheter in place, the needle and the guidewire are removed, leaving only the catheter in the vessel. Fluids are then introduced or removed from the vessel through the catheter by connecting a fluid source or aspiration device to the catheter hub.

Various devices are known for placement of a catheter in the vasculature of a patient. Maintaining sterility of the various components of the device by, for example, preventing the contact of the fingers of the operator with the various parts of the needle, the guidewire and the catheter itself during operation, is important for use of these devices. However, known catheter placement devices typically require the use of two hands for the insertion of the guide wire and advancement of the catheter into the vasculature, which increases the risk of contamination and also increases the risk of inadvertently damaging the vessel due to unintended needle point movement. Moreover, conventional catheter placement devices also prevent the continuous use of ultrasound from the point of skin penetration, vessel access, and wire guide insertion, through to having the first distal portion of the catheter in the vessel and needle point shielded. This makes such conventional catheter placement devices less convenient for use. Additionally, the aforementioned drawbacks of conventional catheter placement devices affect the success rate of insertion into the vasculature.

<CIT> describes a catheter insertion device that allows for single-handed insertion of the catheter within the vasculature of the patient. The catheter insertion device includes a handle, a needle cannula partially within the handle, a guidewire partially within the handle and the needle cannula, and a first actuator connected to the handle and the guidewire. The first actuator is movable in a proximal direction relative to the handle to cause the guidewire to move in a distal direction away from the handle, and is movable in a distal direction relative to the handle to cause the guidewire to move in a proximal direction towards the handle. The catheter insertion device can also include a needle support that stabilizes the needle cannula during insertion of the needle cannula into a patient.

<CIT> provides a fluid administration device which includes a catheter holder having a passage extending through it, a plastic cannula connected at the distal end of the passage, an elastomeric seal at the proximal end of the passage, and a fluid administration side port intermediate the ends of the passage. The device includes a needle holder having a needle cannula extending through the seal, passage, and into the catheter. When the needle holder is in its initial position, the seal is in a passage venting position so that a source of administration fluid can be connected to the side port and the device flushed of air. When the air is removed, the needle assembly is moved to an armed position forcing the seal into a compressed condition in the passage. After the catheter has been placed into the vein, the needle is withdrawn proximally from the catheter holder with the plug sealing the proximal end of the passage.

<CIT> presents an outer unit with a shield having an inner cavity and a soft outer needle fixed to the front end of the shield. An inner unit is provided with an inner hub arranged having a portion inside the inner cavity of the shield, a hard inner needle fixed to the front end of the inner hub, and a tube connected to the inner hub. The inner unit displaces relative to the outer unit from an initial position where the inner needle passes through the outer needle and protrudes from the front end of the outer needle, to a retracted position where the inner needle is stored inside the inner cavity of the shield. The inner hub is provided with an operation unit on the side opposite of the inner needle. When the inner unit is positioned in the initial position, the operation unit is positioned outside of the shield.

Therefore, a need exists for a novel catheter insertion device that allows for single-handed insertion of the catheter within the vasculature of the patient. Additionally, a need exists for a catheter insertion device that allows for easy, safe, and fast catheter placement into a patient's vasculature.

In accordance with the present invention in a first aspect there is provided a catheter insertion device as defined in the appended independent claim <NUM>.

There are, of course, additional implementations that will be described below and which will form the subject matter of the claims. In this respect, it is to be understood that the catheter insertion device is not limited in its application to the details of construction and to the arrangements of the components set forth in the following disclosure or illustrated in the drawings. Also, it is to be understood that the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting. As such, the conception upon which this disclosure is based may readily be utilized as a basis for the designing of other structures, methods, and systems for carrying out the several purposes of the catheter insertion device.

Implementations of the catheter insertion device are described with reference to the drawings, in which like reference numerals refer to like parts throughout.

Referring to <FIG>, an implementation of a catheter insertion device <NUM> including a catheter group <NUM> and an insertion group <NUM> is illustrated. The insertion group <NUM> may be separated from the catheter group <NUM> following partial insertion of a catheter <NUM> in the vasculature of a patient. The catheter group <NUM> also includes an extension line assembly <NUM> in fluid communication with the catheter <NUM>. The extension line assembly <NUM> may be connected to a fluid source or an aspiration device. The insertion group <NUM> includes a handle <NUM> that is initially connected to the catheter group <NUM> and that facilitates the insertion of the catheter <NUM> in the vasculature of the patient.

<FIG> illustrates an exploded view of the separate components of the catheter group <NUM> of the catheter insertion device <NUM>. Referring to <FIG>, a partially transparent perspective view of the assembled catheter group <NUM> of the catheter insertion device <NUM> is illustrated. At its proximal region, the catheter group <NUM> includes an extension line assembly <NUM> that includes an elongated extension line <NUM>, an extension line clamp <NUM>, and an extension line hub <NUM>. A vent plug, as shown in <FIG>, may further be attached to the extension line hub <NUM> during insertion of the needle and then removed prior to use by the practitioner, i.e. before the practitioner connects a syringe to the extension line hub <NUM>. The elongated extension line <NUM> defines an elongated lumen that is in fluid communication with the lumen defined by the catheter <NUM> through the lumen defined by a rigid hub <NUM>. The extension line clamp <NUM> is received around the elongated extension line <NUM> and may be slid in a direction perpendicular to the longitudinal axis of the elongated extension line <NUM> to pinch the elongated extension line <NUM> closed. When the extension line clamp <NUM> pinches the elongated extension line <NUM>, fluid is prevented from flowing beyond the extension line clamp <NUM> either distally towards the catheter <NUM> or proximally towards the extension line hub <NUM>. The extension line hub <NUM> defines a lumen that is in fluid communication with the lumen defined by the elongated extension line <NUM>.

In some implementations, the lumen defined by the extension line hub <NUM> may be tapered from its proximal end towards its distal end, while in other implementations, the lumen defined by the extension line hub <NUM> may have a uniform diameter. The proximal end of the extension line hub <NUM> includes a connector, such as a threaded luer lock, for connection to a fluid source or an aspiration device. The fluid source may be a syringe or an intravenous bag, among others.

At its distal end, the catheter group <NUM> includes the elongated catheter <NUM> that is connected to a catheter hub <NUM>. In particular, the proximal end of the elongated catheter <NUM> connects to the distal end of the catheter hub <NUM>. The rigid hub <NUM> is partially received within the proximal end of the catheter hub <NUM>. The rigid hub <NUM> receives a seal <NUM> that acts as a valve within an internal cavity defined by the rigid hub <NUM>. The proximal end of the rigid hub <NUM> is sealed by a rigid hub cap <NUM>. The proximal end of the rigid hub cap <NUM> has an opening that allows the needle cannula <NUM> and the guidewire <NUM> to pass through the rigid hub cap <NUM> to the seal <NUM>. The elongated catheter <NUM> defines an elongated lumen that is at least partially received within the vasculature of the patient. The catheter hub <NUM> defines a tapered cavity that is in fluid communication with the lumen defined by the elongated catheter <NUM> and the lumen defined by the rigid hub <NUM>. The rigid hub <NUM> also includes a side port <NUM> for receiving the elongated extension line <NUM> of the extension line assembly <NUM>. The lumen defined by the side port <NUM> is in fluid communication with the lumen defined by the elongated extension line <NUM>.

The seal <NUM> is a multi-piece seal, as described in greater detail below. In other implementations, the seal may be one-piece seal, as described in <CIT>,. When the catheter group <NUM> is assembled, the seal <NUM> is enclosed by the rigid hub <NUM> and the rigid hub cap <NUM>. In some implementations, the catheter group <NUM> may not include the extension line assembly <NUM> and the fluid source or aspiration device can be connected to a proximal end of the rigid hub <NUM>.

Referring to <FIG>, an exploded view of the separate components of the insertion group <NUM> of the catheter insertion device <NUM> is illustrated along with an assembled view of the catheter group <NUM>. <FIG> illustrate a perspective view and a side view, respectively, of the assembled catheter group <NUM> and insertion group <NUM> of the catheter insertion device <NUM>. The insertion group <NUM> includes the handle <NUM> that is made up of a right housing <NUM> and a left housing <NUM> that are connected together. Top arm <NUM> and bottom arm <NUM> are formed in the distal region of the handle <NUM>. A needle cannula <NUM> is held within the handle <NUM> and a guidewire <NUM>, which slides through the lumen defined by the needle cannula <NUM>, is also held within the handle <NUM>. The needle cannula <NUM> may be anchored within the handle <NUM> by an interference fit within an inner channel defined by the handle <NUM>, by an adhesive, by a threaded connection, or the like. In some implementations, the needle cannula <NUM> may be, for example, a <NUM> gauge needle.

A needle safety clip <NUM> is placed around the outer surface of the needle cannula <NUM> to cover the sharp needle tip <NUM> following separation of the insertion group <NUM> from the catheter group <NUM>. A needle guard <NUM> covers the portion of the needle cannula <NUM> extending from the handle <NUM> before initial use of the catheter insertion device <NUM>. A first actuator, such as a slider <NUM>, is connected to the top of the handle <NUM> and to the guidewire <NUM> and slides the guidewire <NUM> relative to the handle <NUM> in both proximal and distal directions. In some implementations, the guidewire <NUM> may be a spring wire guide, such as a coiled or a coil-less spring wire guide. The length of the guidewire <NUM> is selected such that, before the slider <NUM> is actuated, the distal end of the guidewire does not extend beyond the sharp needle tip <NUM> of the needle cannula <NUM>.

The guidewire <NUM> may have a variable stiffness, as discussed in further detail below. In some implementations, the guidewire <NUM> may have an outer diameter that is substantially uniform and less than or equal to <NUM> inches (<NUM> centimeters). Preferably, the guidewire <NUM> has an outer diameter that is less than or equal to <NUM> inches when the needle cannula <NUM> is a <NUM> GA needle and the elongated catheter <NUM> is a <NUM> GA catheter, so that the guidewire <NUM> may fit within the lumen defined by the <NUM> GA catheter. In other implementations, the guidewire <NUM> may have a varying diameter that narrows distally, such that the diameter of the guidewire <NUM> is the smallest at a distal end of the guidewire <NUM>. When the guidewire <NUM> is fully advanced, the larger diameter section is immediately distal to the needle <NUM>, which helps to guide the catheter <NUM> during advancement and also directs the catheter's movement during the initial part of the advancement. Further, the distal tip of the guidewire <NUM> has a small outer diameter so that it is sufficiently flexible to help the guidewire <NUM> travel a tortuous path out of the needle <NUM> and into the lumen of the vessel. The guidewire also comprises a large diameter tip, such as a tip shaped like a ball so that it is not sharp. Such a large ball-shaped tip helps the clinician determine whether the entire guidewire is removed after use, since the clinician can see if the ball is there, thus indicating that no piece of the guidewire was left behind. Moreover the ball-shaped tip at the distal end of the guidewire <NUM> is not sharp so as to avoid puncturing a patient's vasculature during operation.

In some implementations, the guidewire <NUM> may be made of a metal, such as a metal alloy. For example, the guidewire <NUM> may be made of an alloy of nickel and titanium. In some implementations, the guidewire <NUM> may be coated with polysulfones, polyfluorocarbons, polyolefins, polyesters, polyurethanes, blends and/or copolymers.

A second actuator, such as a release <NUM>, is also connected to the handle <NUM> of the insertion group <NUM> and to the catheter group <NUM>. The release is configured to slide the catheter group <NUM> relative to the handle <NUM> in a distal direction. The release <NUM> includes a proximal arm <NUM> having an enlarged proximal end <NUM>. A needle support <NUM> is attached to a proximal region of the handle <NUM> and swings upward and downward relative to the handle <NUM>. In particular, the needle support <NUM> is rotationally coupled to the top arm <NUM> by a pivot member <NUM>.

A catheter advancer base <NUM> is removably connected to the catheter hub <NUM> and configured to slidably engage the bottom arm <NUM> of the handle <NUM>, as illustrated in <FIG>. The needle support <NUM> may comprise a rigid plastic material to support the needle cannula <NUM> from bending during insertion into a patient's vasculature. The needle support <NUM> includes two parallel walls <NUM> separated by a distance slightly greater than the outer diameter of the elongated catheter <NUM> in which the needle cannula <NUM> passes in order to stabilize lateral movement of the needle cannula <NUM> during insertion of the needle in the vasculature of the patient. This stabilization is especially important for insertion of the needle relatively deep in the tissue of the patient, such as within an organ of the patient. Additionally, the needle support may further include a textured outer surface to aid gripping by a practitioner during insertion of the catheter into the vasculature of a patient. Examples of such a textured outer surface include various patterns of protrusions, divots, grooves, channels and bumps, among others. In other implementations, the textured surface may be formed of a different material, such as rubber, or may be formed as a roughened surface directly on the needle support <NUM>. In some implementations, such examples of a textured surface may also be added to regions of the catheter advancer base <NUM>, such as to a grip arm <NUM> or grip recess <NUM>, among other areas, in order to aid with gripping.

As illustrated in <FIG> and <FIG>, the needle support <NUM> also includes a top portion <NUM> that abuts the bottom surface of the slider <NUM> before the slider is slid proximally in order to prevent swinging of the needle support <NUM> while the catheter insertion device <NUM> is being inserted in the vasculature of the patient. A lip <NUM> may be provided on the needle support <NUM> that defines a seat region configured to hook around a distal end of the bottom arm <NUM> of the housing in order to prevent the needle <NUM> and/or the catheter <NUM> from popping out of the needle support <NUM> prematurely. Further, the needle support <NUM> may comprise a trapezoidal or other geometric shape, and may have an extended longitudinal length, for example <NUM>, configured to provide additional support to the catheter.

As shown in <FIG>, the needle support <NUM> is free to swing about a pivot member <NUM> when the slider <NUM> is retracted to the extent in which it no longer abuts the top portion <NUM> of the needle support. The catheter advancer base <NUM> is configured to receive the catheter hub <NUM> of the catheter group <NUM>, as will be discussed in greater detail below. A retaining member, such as a protruding clip <NUM>, is provided on the catheter advancer base <NUM> and is configured to further secure the wings of the catheter hub <NUM> to help retain the catheter hub <NUM> to the catheter advancer base <NUM> during deployment.

Referring to <FIG>, the needle guard <NUM> includes an open channel <NUM> defined by two parallel side walls <NUM>. A bottom longitudinal feature and a top longitudinal feature between the parallel side walls <NUM> secure around the needle cannula <NUM>. As such, the bottom and top longitudinal features are spaced apart by a distance slightly greater than the outer diameter of the catheter <NUM>. A tab <NUM> may be provided at the proximal end of the needle guard <NUM> to allow the practitioner to initially lift the needle guard <NUM> out of contact with the slider <NUM>, and then push the needle guard <NUM> distally until the proximal ends of the bottom and top longitudinal features are distal of the sharp needle tip <NUM>. At this point, the needle guard <NUM> disengages from the insertion group <NUM> and may be removed to expose the sharp needle tip <NUM>.

Referring to <FIG>, the catheter advancer base <NUM> and the needle support <NUM> are shown isolated from the rest of the catheter insertion device <NUM>. <FIG> shows the catheter group <NUM> engaged with the catheter advancer base <NUM> and the needle support. An upper surface of the catheter advancer base <NUM> includes a catheter seat <NUM> configured to matingly receive the catheter hub <NUM>. In one implementation, the retaining member <NUM> may be configured to allow the catheter hub <NUM> to securely snap into the catheter seat <NUM>. A pair of spaced apart fasteners, such as pins <NUM>, are provided within the catheter seat <NUM> for connecting to respective connector holes on each wing section, which extend outwardly on opposing sides of the catheter hub <NUM>. The catheter hub <NUM> stays connected to and moves with the catheter advancer base <NUM> when the catheter advancer base is advanced distally during the catheter insertion procedure, as will be discussed in detail below.

The catheter advancer base <NUM> may be disconnected and removed from the catheter hub <NUM> during dressing of the catheter <NUM> to a patient. The catheter advancer base <NUM> is also configured to stay with the catheter <NUM> during advancement and may disconnected therefrom during dressing. A longitudinal slide groove provided on the bottom surface of the catheter advancer base <NUM> defines a guide track that is configured to slidingly engage the bottom arm <NUM> of the housing. This guide track is configured to create a sliding motion of the catheter advancer base <NUM> along the bottom arm <NUM> and also prevent twisting of the catheter advancer base <NUM> and catheter hub <NUM> about their longitudinal axis during such sliding motion when they are advanced forward during catheter insertion.

A grip arm <NUM> is provided on each side of the catheter advancer base <NUM>, and a grip recess <NUM> is also provided on each side of the catheter advancer base <NUM>. The grip arms <NUM> and grip recesses <NUM> allow for alternate grip positions of the catheter advancer base <NUM> by a practitioner, including a choked up hand grip position. For instance, in such a choked up hand position, the user may grip the catheter insertion device <NUM> using one hand by placing a thumb in the grip recess <NUM> located on a first side of the catheter advancer base <NUM>, and a middle finger in the grip recess <NUM> located on an opposite second side of the catheter advancer base <NUM>. The user's index finger may then be curled up so that it can manipulate the slider <NUM>. In this choked up position, the closer a user's hand is located toward the distal end of the handle allows for improved control of gripping and advancing the catheter advancer base <NUM> during operation. The catheter advancer base <NUM> may be symmetric about its longitudinal axis to allow for both right-handed and left-handed placement by a user.

Referring to <FIG>, a cross-sectional side view of the right housing <NUM> including the slider <NUM> and the guidewire <NUM> is illustrated. The handle <NUM> includes a looped proximal end <NUM> through which the guidewire <NUM> passes. In particular, the guidewire <NUM> passes through the channel <NUM> defined by the handle <NUM>. The diameter of the channel <NUM> is slightly greater than the diameter of the guidewire <NUM> so that the guidewire <NUM> stably passes through the channel <NUM>. The slider <NUM> can be slid by a finger, such as the index finger in overhand operation or the thumb in underhand operation, of a practitioner proximally and distally within a chamber <NUM> defined by the handle <NUM>. The chamber <NUM> is sized to be slightly larger than the slider <NUM> to stabilize the movement of the slider <NUM> within the chamber <NUM>.

Due to the looping of the guidewire <NUM> within the looped proximal end <NUM>, proximal movement of the slider <NUM> translates into distal movement of the distal tip of the guidewire <NUM> and vice versa. The looping of the guidewire <NUM>, as opposed to a linear geometry, also enables one-handed operation of the catheter insertion device <NUM> while maintaining continuous grip of the gripping features <NUM> of the handle <NUM>. In addition, the looping of the guidewire <NUM> reduces the likelihood of piercing the vasculature of the patient during advancement of the guidewire <NUM> due to the force of the practitioner being indirectly applied to the guidewire <NUM>.

Referring to <FIG>, a cross-section view of the assembled handle <NUM> with the guidewire <NUM> and the slider <NUM> is illustrated. The handle <NUM> includes gripping features <NUM> that help the practitioner grip the handle <NUM> of the catheter insertion device <NUM>. A right-handed practitioner can, for example, grip the gripping feature <NUM> on the left housing <NUM> using his thumb and grip the gripping feature <NUM> on the right housing using his middle finger. Alternatively, a left-handed practitioner can, for example, grip the gripping feature <NUM> on the left housing <NUM> using his middle finger and grip the gripping feature <NUM> on the right housing using his thumb. The handle <NUM> can be gripped by the practitioner overhand or underhand using the same fingers. The gripping feature <NUM> may comprise a plurality of depressed lines, grooves, corrugations, projections, or a roughened surface, among others, formed on the outer surface of the handle <NUM>. For example, raised lines may be formed in place of the depressed lines, a textured surface may be formed, a plurality of bumps may be formed, or a different material, such as rubber, may be provided over the region of the handle <NUM> corresponding to the gripping features <NUM>.

Three openings are defined by the front face <NUM> of the handle <NUM>. The bottom opening <NUM> is sized to receive the rigid hub cap <NUM> of the catheter group <NUM>. In particular, the diameter of the bottom opening <NUM> is slightly greater than the diameter of the rigid hub cap <NUM>. The middle opening <NUM> is sized to receive the guidewire <NUM> and the needle cannula <NUM>, and the top opening <NUM> is sized to receive the slider <NUM> and the proximal arm <NUM> of the release <NUM>. The top opening <NUM> includes a wider bottom region that receives the slider <NUM> and a narrower top region that receives the proximal arm <NUM> of the release <NUM>. The bottom opening <NUM> and the middle opening <NUM> are separated by a portion of the handle <NUM>, whereas the middle opening <NUM> and the top opening <NUM> are not separated to allow a bottom arm <NUM> of the slider <NUM> to slide within middle opening <NUM>, as explained in greater detail below.

In particular, referring to <FIG>, a transparent side view of a portion of the slider <NUM> is illustrated. The slider <NUM> includes a bottom arm <NUM> extending from the bottom of the slider <NUM> in a direction perpendicular to the longitudinal axis of the slider <NUM>. The bottom arm <NUM> includes a through hole <NUM> that receives the proximal end <NUM> of the guidewire <NUM>. The proximal end <NUM> may include a ball <NUM> to anchor the tip of the proximal end of the guidewire <NUM> in place. The through hole <NUM> has an internal diameter that is slightly larger than the outer diameter of the guidewire <NUM> but slightly smaller than the diameter of the ball <NUM> formed at the tip end of the guidewire <NUM>. The guidewire <NUM> is therefore secured within the through hole <NUM> by an interference fit. The through hole <NUM> does not extend along the entirety of the length of the bottom arm <NUM>, such that the distal end of the through hole <NUM> is closed. Although the ball <NUM> is secured within the through hole <NUM> by an interference fit, in some implementations, the ball <NUM> may be secured by an adhesive, by a threaded connection, or the like.

Due to the interference fit between the through hole <NUM> and the guidewire <NUM>, as the slider <NUM> is moved in a longitudinal direction for a given distance, the guidewire will also move in the opposite direction for the same distance and vice versa. Stated another way, the portion of the guidewire <NUM> that is between the slider <NUM> and the loop portion in the handle will move in the same direction as the slider itself. Conversely, the portion of the guidewire <NUM> that is between the loop portion of the handle and the distal tip will move in the opposite direction of the slider <NUM>. The slider <NUM> includes one or more grips <NUM> that allow a finger, such as the index finger in an overhand operation or the thumb in an underhand operation, of the practitioner to predictably actuate the slider <NUM> in either a distal or proximal direction. In some implementations, the grips <NUM> may be shaped like arrows that point in the proximal direction. Adjacent to each grip <NUM> may be an indicator <NUM>, such as a number, that indicates a relative extension of the guidewire <NUM> distally from the sharp needle tip <NUM>.

The guidewire <NUM> may further comprise a variable stiffness that facilitates insertion of the catheter <NUM> into the vasculature of a patient. In one implementation, the guidewire <NUM> may comprise various segments, such as a first segment defining a thin section of increased flexibility, a second segment defining a tapered transitioned section, and a third segment defining a thick and rigid section that assists the catheter <NUM> in following bends in the guidewire <NUM>. The third segment, which is nearest to the catheter <NUM> when the variable stiffness guidewire is fully extended, has the most stiffness which helps the catheter more easily follow any bends of the guidewire during insertion into a patient's vasculature. The stiffness gradually decreases towards the distal tip of the guidewire, such that the first segment is the most flexible region since it has the smallest diameter, which may be, for example, between. <NUM> in and. The increased flexibility of the first segment allows it to easily bend upon entry into the vasculature in order to minimize piercing through the vasculature wall. As previously noted above, the ball-shaped distal tip of the guidewire <NUM> also helps minimize such piercing through the vasculature wall. The length of the segment of the guidewire may vary. In one implementation, for example, the length of the first and third segments may be approximately <NUM>, and the length of the second segment may be approximately <NUM>.

<FIG> shows a portion of the catheter insertion device depicting the release <NUM> and the catheter advancer base <NUM>, and <FIG> shows a portion of the catheter insertion device depicting the release <NUM> without the catheter advancer base <NUM>. The distal side of the release <NUM> includes a notch <NUM> configured to receive the side port <NUM> of the rigid hub <NUM>. The release <NUM> is sized to be received from around the bottom arm <NUM> to the slider <NUM>. The notch <NUM> is sized to be slightly larger than the diameter of the side port <NUM> to stably secure the side port <NUM>. When the practitioner actuates the release <NUM> in a distal direction using, for example, his index finger, the catheter group <NUM> is also actuated in the distal direction by the same distance through the interface between the notch <NUM> and the side port <NUM>.

As shown in <FIG>, the release <NUM> includes a continuous side wall <NUM>. If the practitioner's finger were to push down onto the slider <NUM> or top arm <NUM> of the handle <NUM> while the needle cannula <NUM> is still in the vasculature of the patient, the resulting downward movement of the needle cannula <NUM> may cause damage to the vasculature of the patient. As such, the release <NUM> includes a distal lip <NUM> that extends radially outward from the release <NUM> in order to help prevent the practitioner's finger from slipping past the distal end of the release <NUM>.

The release <NUM> also includes a proximal arm <NUM> having an enlarged proximal end <NUM>. The proximal arm <NUM> slides within the top opening <NUM> of the handle <NUM>. The enlarged proximal end of the release <NUM> is dimensioned to be larger than the top opening <NUM> so that distal movement of the release <NUM> is limited to the length of the proximal arm <NUM>, and so that the release <NUM> does not separate from the handle <NUM>. The release <NUM> may also include a grip <NUM> that allows a finger, such as the index finger in an overhand operation or the thumb in an underhand operation, of the practitioner to predictably actuate the release <NUM> in either a distal or proximal direction.

Referring to <FIG>, a partially transparent perspective view of a region of the assembled catheter insertion device <NUM> is illustrated. The bottom arms <NUM> of the right housing <NUM> and the left housing <NUM> abut against one another to support the weight of the catheter hub <NUM>. The top arms <NUM> of the right housing <NUM> and the left housing <NUM> are spaced apart by a distance slightly greater than the width of the needle support <NUM> to allow the needle support <NUM> to swing upwards during removal of the catheter group <NUM>. The outer surface of each opposite spaced apart parallel wall <NUM> of the needle support <NUM> includes a pivot member <NUM>, such as a hinge, pivotally connected to the corresponding inner surface of each spaced apart top arm <NUM> of the handle.

The needle support <NUM> includes two parallel walls <NUM> that are perpendicular to the plane of the top surface of the bottom arms <NUM>. As explained above, the parallel walls <NUM> are spaced apart by a distance slightly greater than the outer diameter of the elongated catheter <NUM> to stabilize the needle cannula <NUM> during insertion into the vasculature of the patient. In various implementations, the parallel walls <NUM> of the needle support <NUM> may be sized to mate with the catheter or needle gauge size, such as <NUM> ga, <NUM> ga, or <NUM> ga, among others. Both top arms <NUM> also include a groove <NUM> configured to receive a corresponding tongue of the needle guard <NUM>. Such a tongue and groove connection stably secures the needle guard <NUM> to the handle <NUM> to protect the catheter before use of the catheter insertion device <NUM>.

<FIG> illustrate various operating positions of the catheter insertion device <NUM> during advancement of the catheter group <NUM> from the insertion group <NUM>. When the slider <NUM> is in the fully extended position, as shown in <FIG>, the top portion <NUM> of the needle support <NUM> abuts the bottom surface of the slider <NUM> to block the needle support <NUM> from swinging upward which in turn blocks the catheter advancer base <NUM> from moving, thus locking the release <NUM> from being actuated in order to retain the catheter group <NUM> in place between the needle support <NUM> and the release <NUM>. Upon sliding the slider <NUM> proximally toward the handle <NUM>, as will be discussed below, the top surface <NUM> of the needle support <NUM> becomes free since it no longer abuts the slider. Further, the release <NUM> becomes unlocked such that pushing it distally toward the needle support <NUM> urges the catheter advancer base <NUM> distally into contact with the needle support <NUM>. The catheter advancer base <NUM> accordingly urges the needle support <NUM> to swing upward about the pivot member <NUM>, thus creating a clearance for the entire catheter group <NUM> to be disconnected from the insertion group <NUM>, as shown in <FIG>, so that the catheter <NUM> can be advanced forward into the patient's vasculature.

Before the practitioner slides the slider <NUM> proximally, the distal end <NUM> of the slider <NUM> extends beyond the distal end of the top arm <NUM> and, as such, extends distally along a portion of the needle support <NUM> without extending beyond the needle support. As shown in <FIG>, which illustrates a cross-sectional view of the region of the assembled catheter insertion device <NUM> along the center longitudinal plane of the handle <NUM>, the needle support is oriented in a support position such that the bottom surface of the slider <NUM> abuts against the top portion <NUM> of the needle support <NUM> before the slider <NUM> is slid proximally in order to prevent the needle support <NUM> from swinging out of engagement with the catheter prior to being inserted in the vasculature of the patient.

In this support position, or pre-advancement position, the needle support <NUM> blocks the catheter advancer base <NUM> and the catheter group <NUM> from moving forward. A portion of the catheter <NUM> proximate to the distal end of the needle support <NUM> is supported to resist force from three directions such as from the bottom, the left side, and the right side. A portion of the catheter <NUM> proximate to the proximal end of the needle support <NUM> is supported by the rigid catheter advancer base <NUM> to resist force from a fourth direction, such as from the top. The needle support <NUM> thus provides sufficient support to the catheter <NUM> in order to improve its rigidity in order to avoid excessive bending during insertion into the vasculature of a patient. A lip <NUM> is provided on the bottom of the needle support <NUM> and is configured to hood around a distal end of the bottoms arms <NUM> of the handle in order to prevent the catheter group <NUM> from popping out accidentally during use. Further, when the needle support <NUM> is oriented in the support position, the catheter advancer base <NUM> and the catheter hub <NUM> remain nested between the top and bottom arms <NUM>, <NUM> of the housing <NUM>, and between the release <NUM> and the needle support <NUM> to retain the catheter group <NUM> during use.

<FIG> illustrates a cross-sectional view of the region of the assembled catheter insertion device <NUM> along the center longitudinal plane of the handle <NUM> following actuation of the slider <NUM> by the practitioner. The distal end <NUM> of the slider <NUM> is slid proximal of the needle support <NUM> so that the top portion <NUM> no longer abuts the bottom surface of the slider <NUM> and is free to swing upwards as the catheter group <NUM> is separated from the insertion group <NUM>.

<FIG> illustrates a cross-sectional view of the region of the assembled catheter insertion device <NUM> along the center longitudinal plane of the handle <NUM> following actuation of the release <NUM> by the practitioner. According to another aspect, the practitioner may advance the catheter without using the release <NUM>. As shown in <FIG>, the release <NUM> is pushed forward toward the distal end of the handle such that it correspondingly pushes the rigid hub <NUM> distally so that the catheter advancer base <NUM> contacts the needle support <NUM> and urges the needle support <NUM> to swing upward about the pivot members <NUM>.

The release <NUM> may be pushed forward until it reaches a stop position, after which the practitioner may continue advancing the catheter group <NUM> by gripping the catheter advancer base <NUM> and moving it forward. According to another aspect, the practitioner may grip the extension line <NUM>, or more particularly an arm of the rigid hub that contains the extension line inside of it, to advance the catheter group <NUM> forward. As previously discussed, a practitioner may grip each grip recess <NUM> of the catheter advancer base <NUM> in a choked up position in order to facilitate advancement of the catheter advancer base <NUM>. As shown in <FIG>, the needle support <NUM> continues to swing out of the way of the catheter advancer base <NUM> and catheter hub <NUM> during advancement thereof. The needle support <NUM> is therefore moved out of the path of the catheter advancer base <NUM> and the catheter hub <NUM> in order to allow the distal end of the catheter advancer base <NUM> and the catheter hub <NUM> to extend distally beyond the needle support <NUM>. The catheter advancer base <NUM> and the catheter hub <NUM> thus initially abut the needle support <NUM>, and distally move past the needle support <NUM> once the needle support <NUM> is urged by the catheter advancer base <NUM> to swing upward to provide clearance for full deployment of the catheter group <NUM>, as shown in <FIG>. Thus, the catheter group is advanced distally such that the catheter group <NUM> is distal of the distal end of the handle <NUM>. At this point, the needle safety clip <NUM> is still mounted to the rigid hub cap <NUM>, as explained below.

Referring to <FIG>, a perspective view of the needle safety clip <NUM> mounted to the rigid hub <NUM> is illustrated. Referring to <FIG>, a rear view of the needle safety clip <NUM> is illustrated. Referring to <FIG>, a front view of the needle safety clip <NUM> is illustrated. The needle safety clip <NUM> includes a proximal wall <NUM> that includes a round aperture <NUM> having a diameter slightly greater than the outer diameter of the needle cannula <NUM>. In some implementations, the round aperture <NUM> may have a sharp inner surface to grip the outer surface of the needle cannula <NUM> when the needle cannula <NUM> is at an angle with respect to the central axis of the round aperture <NUM>. In other words, the sharp inner surface of the round aperture <NUM> digs into the outer surface of the needle cannula <NUM> when the needle cannula <NUM> is tilted with respect to the needle safety clip <NUM>, as shown in <FIG>, to prevent movement of the needle cannula <NUM> with respect to the needle safety clip <NUM>.

Referring back to <FIG>, a top wall <NUM> extends distally of the proximal wall <NUM> and defines a top opening <NUM>. The top opening <NUM> allows the spring arm <NUM> to extend partially above the top wall <NUM> in its compressed state, as shown in <FIG>. The spring arm <NUM> is illustrated having a C-shape. However, the spring arm <NUM> may be designed to have other shapes that are resilient and may be shaped to be, for example, stepped, blocked, jagged, or amorphous. The top distal portion of the spring arm <NUM> is connected to the distal bottom surface of the top wall <NUM> to secure the spring arm <NUM> to the rest of the needle safety clip <NUM>. The spring arm <NUM> may be made of any flexible material, such as, for example, plastic, stainless steel, aluminum or titanium. The spring arm <NUM> may be made of the same material as the rest of the needle safety clip <NUM> or made of a different material having the desired characteristics.

A first distal wall <NUM> extends downward from the distal end of the top wall <NUM> and defines a first distal channel. A second distal wall <NUM> curves upward from the first distal wall <NUM> and defines a second distal channel. A narrow tab <NUM> extends distally from the distal end of the second distal wall <NUM> and a broad tab <NUM> extends distally from the narrow tab <NUM>. The narrow tab <NUM> is received within a narrow recess <NUM> at the top of the rigid hub cap <NUM> and the broad tab <NUM> is received within a broad recess <NUM> at the top of the rigid hub cap <NUM> to mount the needle safety clip <NUM> to the rigid hub cap <NUM>. When the needle safety clip <NUM> is mounted to the rigid hub cap <NUM>, the narrow tab <NUM> prevents lateral movement of the needle safety clip <NUM> while broad tab <NUM> prevents longitudinal movement of the needle safety clip <NUM>.

Turning back to <FIG>, the first distal wall <NUM> defines a channel having a round top region <NUM> and a rectangular bottom region <NUM>. The diameter of the round top region <NUM> is slightly larger than the outer diameter of the needle cannula <NUM> to allow the needle cannula <NUM> to slide through the round top region <NUM> with low friction and to prevent lateral movement of the needle cannula <NUM>. The rectangular bottom region <NUM> has a width that is less than the outer diameter of the needle cannula <NUM> to both keep the safety from springing upward until the needle tip is between the first distal wall and the second distal wall and block the needle cannula <NUM> from being able to extend distally past the second distal wall <NUM>, as explained in greater detail below. The second distal wall <NUM> also includes a round top region <NUM> that has a diameter that is greater than the outer diameter of the needle cannula <NUM> and a rectangular bottom region <NUM>. The width of the rectangular bottom region <NUM> may be equal to the diameter of the round top region <NUM> to allow the needle cannula <NUM> to move downward relative to the needle safety clip <NUM> under force of the spring arm <NUM>.

Referring to <FIG>, a perspective view of the needle safety clip <NUM> released from the rigid hub <NUM> is illustrated. After the needle cannula <NUM> is withdrawn from the rigid hub <NUM>, it passes proximally through the round top region <NUM> of the second distal wall <NUM> and then through the round top region <NUM> of the first distal wall <NUM>. Once the round top region <NUM> does not stabilize the needle cannula <NUM> (that is, once the width of the sharp needle tip, Wn, becomes smaller than the width of the rectangular bottom region <NUM>), the needle safety clip <NUM> is free to tilt relative to the needle cannula <NUM>. The spring arm <NUM> then decompresses, as shown in <FIG>, to push the needle safety clip <NUM> upward. Because the needle cannula <NUM> is still within the round aperture <NUM>, it is gripped by the sharp inner edges of the round aperture <NUM>, which prevents longitudinal movement of the needle cannula <NUM> with respect to the needle safety clip <NUM>. As such, the first distal wall <NUM> and the second distal wall <NUM> cover the sharp needle tip <NUM> and protect the practitioner from potential needle pricks.

Referring to <FIG>, a perspective view of the sharp needle tip <NUM> of the needle cannula <NUM> is illustrated. The sharp needle tip <NUM> may be formed by back grinding as illustrated, or in other implementations, the sharp needle tip <NUM> may have a lancet tip. The sharp needle tip <NUM> tapers in the distal direction such that the width Wn of the sharp needle tip <NUM> at a plane along the sharp needle tip <NUM> is equal to the width of the rectangular bottom region <NUM>. As such, the needle cannula <NUM> cannot extend distally past the first distal wall <NUM> beyond that plane where the sharp needle tip <NUM> has the width Wn when the needle safety clip <NUM> is released from the rigid hub <NUM> because the needle cannula <NUM> is wider than the rectangular bottom region <NUM> proximal of that plane. However, the length Ln may still extend distally beyond the first distal wall <NUM> because the needle cannula <NUM> is thinner than the rectangular bottom region <NUM> distal of that plane. Therefore, as shown in <FIG>, to prevent exposure of the sharp needle tip <NUM> beyond the second distal wall <NUM>, the needle safety clip <NUM> is designed so that the distance Dc between the first distal wall <NUM> and the second distal wall <NUM> in the axis aligned with the longitudinal axis of the needle cannula <NUM> is greater than the length Ln.

As shown throughout the <FIG>, the needle cannula <NUM> may further comprise a swage <NUM> having a pressed area of the metal tube near the distal tip of the needle. The swage may have a substantially oval-shaped, or ellipse-shaped, cross sectional bulge that differs from the round cross section of the rest of the needle. The major diameter of the oval-shaped swage <NUM> is smaller than the cut out portions of the first and second distal walls <NUM>, <NUM> of the safety latch <NUM>, but is larger than the hole <NUM> in the proximal wall <NUM>. This arrangement further ensures the safety clip <NUM> cannot be pulled distally off the tip of the needle.

Additionally, the minor diameter of the oval-shaped swage is larger than the width of the rectangular bottom region cut out <NUM> in the first distal wall of the safety latch. This ensures that the safety would not spring upward when the swage passes by the first distal wall <NUM> even if the rectangular bottom region <NUM> slot of the safety is parallel to the swage instead of being perpendicular, as it normally is. Moreover, the inner diameter of the swage <NUM> is greater than the outer diameter of the guidewire <NUM> so that the guidewire <NUM> can pass therethrough.

Referring to <FIG>, partially transparent side views of the catheter insertion device <NUM> during separation of the catheter group <NUM> are illustrated. As explained above in connection with <FIG>, the slider <NUM> is initially slid proximally to provide clearance to allow the needle support <NUM> to swing upwards, and then the release <NUM> is slid distally to push the catheter advancer base <NUM> forward. The practitioner can then fully advance the catheter into the patient, i.e. until the distal end of the catheter hub <NUM> almost touches the skin. The practitioner then uses the hand that is not grasping the handle <NUM> to stabilize the catheter group <NUM>. For example, the practitioner can use his non-dominant hand to grasp the catheter hub <NUM> and/or the rigid hub <NUM> to stabilize the rigid hub <NUM> at a constant position within the vasculature of the patient. The practitioner can then pull the insertion group <NUM> proximally to remove the needle cannula <NUM> from the catheter group <NUM>.

As shown in <FIG>, the insertion group <NUM> is pulled proximally to the point where the sharp needle tip <NUM> of the needle cannula <NUM> is proximal of the second distal wall <NUM>, but still distal of the first distal wall <NUM>. As such, the plane where the sharp needle tip <NUM> has the width Wn is still distal of the first distal wall <NUM> and the needle cannula <NUM> is stabilized within the round top region <NUM>. As shown in <FIG>, the width, Wn, of the sharp needle tip <NUM> is less than the width of the rectangular bottom region <NUM> and, therefore, the needle safety clip is free to tilt relative to the needle cannula. The spring arm <NUM> then decompresses to tilt the needle safety clip upward, so that the second distal wall <NUM> and/or the first distal wall <NUM> cover the sharp needle tip <NUM>.

Referring to <FIG>, a perspective view of an implementation of the seal <NUM> is illustrated. The seal <NUM> is a two-part seal that includes a proximal part <NUM> and a distal part <NUM>. Referring to <FIG>, the proximal part <NUM> has a flat proximal face <NUM> and a proximal region <NUM> having a reduced diameter. The proximal part <NUM> defines an inner cavity <NUM> that extends along a majority of the longitudinal axis of the proximal part <NUM>. Relative to the seal <NUM>, the inner cavity <NUM> reduces the surface area of the seal <NUM> that the needle cannula <NUM> contacts, thereby reducing the frictional forces applied during advancement of the catheter group and removal of the needle cannula <NUM>. According to further aspects, lubricant may be added the cavity <NUM> to further reduce these frictional forces. Additionally, the cavity <NUM> also provides empty space for the displaced seal material volume to move into when the cannula is inserted into the seal during the shelf life of the device, i.e. prior to removal of the cannula. This prevents a small portion of the seal material from being displaced out the back of the rigid cap of the catheter or distally into the catheter, i.e. inside the rigid catheter hub.

Referring to <FIG>, the distal part <NUM> is solid and includes a proximal region <NUM> of reduced diameter. The diameter of the proximal region <NUM> is slightly smaller than the diameter of the inner cavity at the distal end of the proximal part <NUM> to prevent lateral movement of the distal part <NUM> relative to the proximal part <NUM> when the seal <NUM> is assembled within the rigid hub <NUM> and the rigid hub cap <NUM>. The distal part <NUM> also has a tapered distal region with a diameter that reduces distally. The seal <NUM> may be made of a resilient material, such as, for example, silicon, rubber, polyisoprene, or the like.

Referring to <FIG>, a partial cross-sectional view of the assembled rigid hub <NUM>, two-part seal <NUM>, and rigid hub cap <NUM> taken along the plane defined by the diameter of the rigid hub <NUM> and the longitudinal axis of the side port <NUM> is illustrated. The proximal region <NUM> having the reduced diameter is compressed within the rigid hub cap <NUM> to force the seal material radially inward in response to pressure applied to the flat distal face <NUM>. The flat distal face <NUM> is flush with the distal end of the rigid hub cap <NUM> to allow for complete evacuation of the inner volume of the rigid hub <NUM> when flushing the catheter insertion device <NUM>.

As shown in <FIG>, the distal seal diameter is larger than the diameter of the mating cavity in the rigid hub. This helps to generate a compression force to prevent air or fluid leakage after the needle/cannula is removed during routine use of the catheter by the practitioner, such as for drawing blood or injecting fluid. Further, the radiused portion on the distal seal (in the middle of the assembly) mates with the corresponding radius on the inside of the rigid cap to facilitate placement and location of the distal seal, as well as resist pressure from the distal end inside the catheter body and extension line in order to keep the seal in place. Additional compression forces on the proximal side of the seal further close off the previous hole from the cannula. Also, the proximal side of the seal may be flush, or just beyond flush, with the outside of the rigid cap to allow cleaning of the hub.

Referring to <FIG>, a perspective view of a distal region of the needle cannula <NUM> is illustrated. The distal region of the needle cannula <NUM> includes one or more and, preferably, eight echogenic features. The echogenic features may be, for example, through holes <NUM> drilled within opposite sides of the needle cannula <NUM>. Although the sharp needle tip <NUM> is echogenic when observed under ultrasound, the through holes <NUM> improve the echogenicity of the needle cannula <NUM>. In particular, the through holes <NUM> are visible through the wall thickness of the elongated catheter <NUM> under ultrasound. In addition, through holes <NUM> allow for blood flow from within the lumen of the needle cannula <NUM> to the outer surface of the needle cannula <NUM>. The blood then flows to the inner surface of the catheter <NUM> to allow for visual observation of the blood.

The through holes <NUM> are angled relative to one another. For example, the through holes <NUM> are drilled <NUM> degrees apart from one another, as shown in <FIG>. The different angles of the through holes <NUM> and the number of through holes <NUM> results in at least two echogenic features being visible under ultrasound at all times - one echogenic feature being the sharp needle tip <NUM> and the other being at least one of the through holes <NUM>. The two visible echogenic features enable the practitioner to know the angle of insertion of the needle cannula <NUM>.

Claim 1:
A catheter insertion device comprising:
a handle (<NUM>) having a proximal body portion and two cantilever arms (<NUM>, <NUM>) each extending distally from said body portion;
a needle cannula (<NUM>) having a proximal end located within the handle proximal body portion, said needle cannula extending distally from the handle proximal body portion and defining a distal cantilever portion disposed partially between the two cantilever arms (<NUM>, <NUM>) of the handle (<NUM>);
a catheter assembly (<NUM>) removably coupled to the handle (<NUM>) and configured to slide on the needle cannula (<NUM>), the catheter assembly (<NUM>) comprising an elongated catheter (<NUM>), a catheter hub (<NUM>) connected to a proximal end of the elongated catheter (<NUM>), and a catheter advancer base (<NUM>) releasably connected to the catheter hub (<NUM>); and
a needle support (<NUM>) having two parallel walls (<NUM>) pivotally connected to the handle (<NUM>), said needle support (<NUM>) pivoting between a first position and a second position, said needle support (<NUM>) configured to support the needle cannula (<NUM>) on the cantilever portion of said needle cannula when the needle support is in the first position and said needle cannula (<NUM>) is disposed between said two parallel walls (<NUM>) of the needle support, said needle support (<NUM>) blocking distal advancement of the catheter assembly (<NUM>) when said needle support is in the first position.