Patent Description:
In one aspect of the present invention, there is disclosed an insertion tool according to claim <NUM>. Preferred embodiments of the invention are set forth in the dependent claims.

Briefly summarized, embodiments of the present disclosure are directed to an insertion tool for inserting a catheter or other tubular medical device into a body of a patient. The insertion tool unifies needle insertion, guidewire advancement, and catheter insertion in a single device to provide for a simple catheter placement procedure.

According to the invention, the insertion tool comprises a housing in which at least a portion of the catheter is initially disposed, a hollow needle distally extending from the housing with at least a portion of the catheter pre-disposed over the needle, and a guidewire pre-disposed within the needle. An advancement assembly is also included for selectively advancing the guidewire distally past a distal end of the needle in preparation for distal advancement of the catheter. In one embodiment a catheter advancement assembly is also included for selectively advancing the catheter into the patient. Each advancement assembly can include a slide or other actuator that enables a user to selectively advance the desired component.

In one embodiment the catheter advancement assembly further includes a handle that is initially and removably attached to a hub of the catheter within the housing. Distal movement of handle by a user in turn distally moves the catheter distally from the housing. The handle can include a needle safety component for isolating a distal tip of the needle when the needle is removed from the catheter and the distal tip received into the handle.

The embodiments of the invention are illustrated in <FIG> and <FIG>. The examples shown in the other figures do not form part of the invention but represent background art that is useful for understanding the invention.

These and other features of embodiments of the present invention will become more fully apparent from the following description and appended claims, or may be learned by the practice of embodiments of the invention as set forth hereinafter. While the implantation methods described herein do not form part of the invention, they are disclosed as they represent useful background for understanding the invention. In addition, the values expressed hereafter in the imperial system must be converted to the metric system using the conversion whereby one inch is equivalent to approximately <NUM>.

Reference will now be made to figures wherein like structures will be provided with like reference designations. It is understood that the drawings are diagrammatic and schematic representations of exemplary embodiments of the present invention, and are neither limiting nor necessarily drawn to scale.

For clarity it is to be understood that the word "proximal" refers to a direction relatively closer to a clinician using the device to be described herein, while the word "distal" refers to a direction relatively further from the clinician. For example, the end of a catheter placed within the body of a patient is considered a distal end of the catheter, while the catheter end remaining outside the body is a proximal end of the catheter. Also, the words "including," "has," and "having," as used herein, including the claims, shall have the same meaning as the word "comprising.

Embodiments of the present invention are generally directed to a tool for assisting with the placement into a patient of a catheter or other tubular medical device. For example, catheters of various lengths are typically placed into a body of a patient so as to establish access to the patient's vasculature and enable the infusion of medicaments or aspiration of body fluids. The catheter insertion tool to be described herein facilitates such catheter placement. Note that, while the discussion below focuses on the placement of catheters of a particular type and relatively short length, catheters of a variety of types, sizes, and lengths can be inserted via the present device, including peripheral IV's intermediate or extended-dwell catheters, PICC's, central venous catheters, etc. In one embodiment, catheters having a length between about <NUM> inches and about <NUM> inches can be placed, though many other lengths are also possible. In another embodiment a catheter having a length of about <NUM> inches can be placed.

Reference is first made to <FIG> and <FIG>, which depict various details regarding a catheter insertion tool ("insertion tool"), generally depicted at <NUM>, according to one embodiment. As shown, the insertion tool <NUM> includes a housing <NUM> that in turn includes a top housing portion 12A separably mated with a bottom housing portion 12B. A needle hub <NUM> supporting a hollow needle <NUM> is interposed between the housing portions 12A and 12B. The needle <NUM> extends distally from the needle hub <NUM> so as to extend through the body of the insertion tool <NUM> and out a distal end of the housing <NUM>. In another embodiment, the needle is at least partially hollow while still enabling the functionality described herein.

A notch <NUM> is defined through the wall of the needle <NUM> proximate the distal end thereof. The notch <NUM> enables flashback of blood to exit the lumen defined by the hollow needle <NUM> once access to the patient's vasculature is achieved during catheter insertion procedures. Thus, blood exiting the notch <NUM> can be viewed by a clinician to confirm proper needle placement in the vasculature, as will be explained further below.

The insertion tool <NUM> further includes a guidewire advancement assembly <NUM> for advancing a guidewire <NUM> through the needle <NUM> and into the vasculature of the patient once access by the needle has been achieved. The guidewire <NUM> is pre-disposed within the lumen of the needle <NUM>, with a proximal end of the guidewire positioned proximate the proximal end of the needle hub <NUM>, as best seen in <FIG> and <FIG>. The guidewire advancement assembly <NUM> includes a guidewire lever <NUM> that selectively advances the guidewire in a distal direction during use of the insertion tool <NUM> such that the distal portion of the guidewire extends beyond the distal end of the needle <NUM>. The guidewire lever <NUM> includes a lever tab <NUM> that engages the proximal end of the guidewire <NUM> so to push the guidewire through the lumen of the needle <NUM>.

The guidewire advancement assembly <NUM> further includes a slide <NUM> that is slidably attached to the top housing portion 12A. Two tabs 24A of the guidewire lever <NUM> operably attach to the slide <NUM> so that selective movement by a user of the slide results in corresponding movement of the lever <NUM>, and by extension, the guidewire <NUM>. Engagement of the lever tabs 24A to the slide <NUM> also maintains attachment of the slide to the housing <NUM>. Of course, other engagement schemes to translate user input to guidewire movement could also be employed. Suitable tracks are included in the top housing portion 12A to enable sliding movement of the slide <NUM> and the lever <NUM>, including a track <NUM> extending to the distal end of the housing <NUM>.

The slide <NUM> includes two arms <NUM> that wrap partially about rails <NUM> defined by the housing <NUM>. In particular, during initial distal advancement of the slide <NUM>, the arms <NUM> slide on a bottom housing rail 32A, best seen in <FIG>. During further distal advancement of the slide <NUM>, the arms <NUM> slide past the bottom housing rail 32A and on to a top housing rail 32B, best seen in <FIG> and <FIG>. With the arms <NUM> of the slide <NUM> no longer engaged with the bottom housing rail 32A, the two housing portions 12A and 12B are able to separate, as will be described further below.

The guidewire lever <NUM> includes a locking arm <NUM> resiliently disposed so as to spring up and engage an extension 36A defined in the interior of the top housing portion 12A when the slide <NUM> has been fully slid distally. This prevents inadvertent retraction of the guidewire <NUM> once distally extended, which could otherwise cause unintended severing of a distal portion of the guidewire by the distal tip of the needle <NUM> during insertion procedures. Note that engagement of the locking arm <NUM> with the extension 36A can provide tactile and/or audible feedback to the user in one embodiment so as to indicate full distal extension of the guidewire <NUM>.

The insertion tool <NUM> further includes a catheter advancement assembly <NUM> for selectively advancing in a distal direction a catheter <NUM>, pre-disposed in the housing <NUM>, and including a catheter tube <NUM> and a hub <NUM> at a proximal end thereof. As seen in <FIG>, the catheter <NUM> is partially and initially pre-disposed within a volume defined by the housing <NUM> such that the lumen of the catheter tube <NUM> is disposed over the needle <NUM>, which in turn is disposed over the guidewire <NUM>, as mentioned.

In particular, the catheter advancement assembly <NUM> includes a handle <NUM> that defines a base 48A and two arms <NUM> extending from the handle base. Each arm <NUM> defines a grip surface 50A, finger grabs 50B, and one of two teeth 50C. The grip surfaces 50A and finger grabs 50B enable the handle to be grasped or contacted by a user in order to selectively advance the catheter <NUM> in a distal direction during use of the insertion tool <NUM> to insert the catheter into the body of the patient. The teeth 50C engage corresponding raised surfaces on the hub <NUM> so as to removably connect the handle <NUM> to the catheter <NUM>.

Additional components are included in relation to the handle <NUM> of the catheter advancement assembly <NUM>. A plug, or valve <NUM>, is interposed between the handle base 48A and the catheter hub <NUM> to prevent blood spillage when the catheter is first introduced into the patient vasculature. A safety housing <NUM>, including a needle safety component <NUM> therein, is removably attached to the handle <NUM> between the arms <NUM>. Specifically, protrusions <NUM> included on the inner surfaces of the handle arms <NUM> engage with corresponding recesses <NUM> (<FIG>) defined in the safety housing <NUM> to removably secure the safety housing to the handle <NUM>. A cap <NUM> supports the needle safety component <NUM> and covers the end of the safety housing <NUM>. As shown in <FIG>, the needle <NUM> initially extends through the aforementioned components in the order as shown in <FIG>. Further details regarding the operation of these components are given below.

Note that in one embodiment the outer diameters of the needle <NUM> and the catheter tube <NUM> are lubricated with silicone or other suitable lubricant to enhance sliding of the catheter tube with respect to the needle and for aiding in the insertion of the catheter into the body of the patient.

The insertion tool <NUM> further includes a support structure <NUM> for stabilizing the needle <NUM> proximate its point of exit from the housing <NUM>. In the present embodiment, the support structure <NUM> includes an interface <NUM> of the top housing portion 12A and bottom housing 12B that is shaped to closely match the round shape of the needle <NUM> and catheter tube <NUM>. The interface <NUM> stabilizes the needle <NUM> so as to prevent excessive "play" in the needle, thus improving user accuracy when initially accessing the vasculature of the patient.

As best seen in <FIG>, the top housing 12A, the needle hub <NUM>, and the bottom housing 12B include engagement features <NUM> to maintain attachment of the proximal end of the housing <NUM> even when more distal portions of the housing are separated, discussed below. Note, however, that various types, sizes, and numbers of engagement features can be employed to achieve this desired functionality.

<FIG> depict various stages of use of the insertion tool <NUM> in placing the catheter <NUM> in the vasculature of a patient. For clarity, the various stages are depicted without actual insertion into a patient being shown. With the insertion tool <NUM> in the configuration shown in <FIG>, a user grasping the insertion tool <NUM> first guides the distal portion of the needle <NUM> through the skin at a suitable insertion site and accesses a subcutaneous vessel. Confirmation of proper vessel access having been achieved is evident via blood flash, i.e., the presence of blood between the outer diameter of the needle <NUM> and the inner diameter of the catheter tube <NUM> due to blood passing out the notch <NUM> from the hollow interior of the needle. Note that in one embodiment, the presence of blood in the safety housing <NUM>, which in one embodiment is a translucent housing, can serve as a secondary blood flash indicator due to blood entering the housing from the needle <NUM> when the vessel is accessed.

After needle access to the vessel is confirmed, the guidewire advancement assembly <NUM> is actuated, wherein the slide <NUM> is advanced by the finger of the user to distally advance the guidewire <NUM> (<FIG>), initially disposed within the hollow needle <NUM>. Note that the guidewire is distally advanced by the lever <NUM>, which is operably attached to the slide <NUM>. Note also that during distal advancement of the slide <NUM>, the slide arms <NUM> thereof travel along the rails <NUM> on either side of the housing <NUM>: first the bottom housing rails 32A, then the top housing rails 32B.

Distal guidewire advancement continues until the slide <NUM> has been distally slid its full travel length, resulting in a predetermined length of the guidewire <NUM> extending past the distal end of the needle <NUM>, as shown in <FIG>. In one embodiment, further distal advancement of the slide <NUM> is prevented by contact of the lever tab <NUM> with a distal portion of the needle hub <NUM>, as shown in <FIG>. <FIG> show that, upon full distal advancement of the slide <NUM>, the slide arms <NUM> thereof are no longer engaged with the bottom housing rails 32A, but rather with only the top housing rails 32B. This in turn enables the housing portions 12A and 12B to separate, as seen further below.

As seen in <FIG>, once the guidewire <NUM> has been fully extended within the vessel of the patient (<FIG>), the catheter advancement assembly <NUM> is actuated, wherein the handle <NUM> is distally advanced by the user to cause the catheter tube <NUM> to slide over distal portions of the needle <NUM> and guidewire <NUM> and into the patient's vasculature via the insertion site. <FIG> show that, as the catheter is advanced via the handle <NUM>, the housing portions 12A and 12B are easily separated so as to enable the catheter hub <NUM> to exit the distal end of the housing <NUM> and for the catheter to be inserted into the patient vasculature to a suitable degree.

Note that, as shown in <FIG>, during removal of the catheter from within the housing <NUM> of the insertion tool <NUM>, the catheter slides distally along the needle <NUM> until the distal needle tip is received into the safety housing <NUM> and engaged with the needle safety component <NUM>. <FIG> shows that the insertion tool <NUM> can then be separated from the catheter <NUM>, leaving the handle <NUM> still attached to the catheter hub <NUM>. As mentioned, the handle <NUM> includes the valve <NUM> interposed between the catheter hub <NUM> and the handle <NUM>. Upon removal of the needle <NUM> and safety housing <NUM> from the catheter <NUM>, the valve <NUM> occludes the catheter lumen so as to prevent inadvertent blood spillage from the catheter hub <NUM>. As shown in <FIG>, the handle <NUM> be removed from engagement with the catheter hub <NUM> via pulling, twisting, etc., so as to disengage the teeth 50C of the handle from the hub. An extension leg can be attached to the catheter hub and the catheter <NUM> dressed down, per standard procedures. Then housing <NUM> and handle <NUM> of the insertion tool <NUM> can be discarded.

1OA-IOC give further details regarding the safety housing <NUM>, as well as the needle safety component <NUM> and its interaction with the needle <NUM> in isolating the distal end thereof. As shown, the safety housing <NUM> is configured to enable the needle <NUM> to pass therethrough during use of the insertion tool <NUM>, as has been described, exiting the housing via the extension <NUM> on the distal end of the housing. The cap <NUM> is placed into the proximal end of the safety housing <NUM> and is configured to support the needle safety component <NUM> such that the needle <NUM> initially passes through the safety housing, the cap, and the needle safety component. Note that the extension <NUM> of the safety housing <NUM> in the present embodiment extends into the valve <NUM> so as to open the valve during use of the insertion tool <NUM>, which eliminates undesired friction between the valve and the needle.

<FIG> shows that the needle safety component <NUM> includes a bent body, or binding element <NUM> through which the needle initially extends, and a friction element <NUM>. As seen in <FIG>, when the needle <NUM> is withdrawn from the catheter <NUM> (<FIG>), the distal tip of the needle is withdrawn proximally through the extension <NUM> and past the distal portion of the needle safety component such that the needle is no longer in contact therewith. This enables the friction element <NUM> to cause the binding element <NUM> to cant slightly, thus binding the needle <NUM> in place and preventing its further travel with respect to the safety housing <NUM> and isolating the needle distal tip within the housing so as to prevent inadvertent needle sticks. In the present embodiment the friction element <NUM> includes a suitably sized O-ring. Suitable O-rings can be acquired from Apple Rubber Products, Lancaster, NY, for instance. Note that further details regarding the needle safety component, its operating principles, and similar devices are disclosed in <CIT>, <CIT>,<CIT>, <CIT>, <CIT>, and<CIT>. Of course, other needle safety devices can be employed to isolate the distal end of the needle.

Reference is now made to <FIG> in describing a catheter insertion tool <NUM> according to one embodiment. Note that in this and succeeding embodiments, various features are similar to those already described in connection with the above embodiment. As such, only selected aspects of each embodiment to follow will be described.

The insertion tool <NUM> includes a housing <NUM> defined by a top housing portion 112A and a bottom housing portion 112B that together partially enclose the catheter <NUM>. A needle hub <NUM> supporting a distally extending needle <NUM> is included for disposal within the housing <NUM> and positioned such that the catheter tube <NUM> of the catheter <NUM> is disposed over
the needle. Note that partial enclosure of the catheter by the insertion tool in this and other embodiments enables a clinician to manipulate the insertion tool with hands that are closer to the distal end of the needle than what would otherwise be possible.

<FIG> give further details regarding the needle hub <NUM>, which is attached to the top housing portion 112A, A needle holder <NUM>, included on a distal end of the needle hub <NUM>, receives the proximal end of the needle <NUM> therein. The needle <NUM> is secured within the needle holder <NUM> via adhesive, welding, or other suitable manner. Extensions <NUM> are included on opposite sides of the needle holder <NUM> and are configured to be slidably received within corresponding slots <NUM> defined on the sides of the bottom housing portion 112B. Such engagement enables the bottom housing portion 112B to slide distally with respect to the top housing portion 112A.

A top rail <NUM> is included on the needle hub <NUM> and is configured to engage a corresponding slot <NUM> defined in the proximal portion of the top housing portion 112A so as to secure the needle hub to the top housing portion. A lock out arm <NUM> is also included with the needle hub <NUM> and positioned to engage the back plate <NUM> when the bottom housing portion 112B is slid distally to extend the guidewire from the needle <NUM>, thus preventing its retraction. Note that the guidewire <NUM> initially distally extends from the back plate <NUM> and through the needle holder <NUM> and needle <NUM>, as best seen in <FIG>.

A guidewire advancement assembly <NUM> is included to selectively advance a guidewire <NUM>, initially disposed within the lumen of the needle, distally past the distal end of the needle <NUM>. The guidewire advancement assembly <NUM> includes the bottom housing portion 112B to which the guidewire <NUM> is attached at a proximal back plate <NUM> thereof. As will be seen, the bottom housing portion 112B is distally slidable with respect to the top housing portion 112A to enable selective distal advancement of the guidewire <NUM>.

The insertion tool <NUM> further includes a catheter advancement assembly <NUM> for selectively advancing the catheter <NUM> over the needle <NUM>. The advancement assembly <NUM> includes a handle <NUM> initially and slidably disposed between the top and bottom housings 112A and112B and removably attached to the hub <NUM> of the catheter <NUM>. As best seen in <FIG> and <FIG>, the handle <NUM> includes two arms <NUM> for allowing a user to selectively slide the handle in order to advance the catheter <NUM>. The handle <NUM> further includes a recess <NUM> in which is placed a needle safety component <NUM> for isolating the distal tip of the needle <NUM> when the needle is withdrawn from the catheter <NUM>. Further details regarding the needle safety component are disclosed in <CIT>, <CIT>, <CIT>, <CIT>,<CIT>, and <CIT>.

The insertion tool <NUM> further includes a support structure <NUM> for stabilizing the needle <NUM> proximate the distal end of the housing <NUM>. The support structure <NUM> in the present embodiment includes two flaps <NUM> that arc hingedly connected to the distal portion of the bottom housing portion 112B. When closed as seen in <FIG> and <FIG>, the flaps <NUM> serve to stabilize the needle <NUM> to assist the user of the insertion tool <NUM> in inserting the needle into the patient. When open (<FIG>), the flaps <NUM> provide an opening to enable the catheter hub <NUM> to be removed from the distal end of the housing <NUM>, as will be detailed further below. Before the bottom housing portion 112B is slid with respect to the top housing portion 112A, the flaps <NUM> are disposed in a track <NUM> defined by the top housing portion. Other types and configurations of support structures can also be employed. The insertion tool <NUM> further includes gripping surfaces <NUM> on either side of the housing <NUM> to aid in use of the tool during catheter insertion procedures, detailed below.

<FIG> depict various stages of use of the insertion tool <NUM> in inserting a catheter into a patient. With the insertion tool <NUM> in the configuration shown in <FIG>, vascular access is achieved with the needle <NUM> via user insertion of the needle into the patient at an insertion site. Confirmation of vessel access can be achieved via the observation of blood flashback via a distal notch in the needle <NUM>, as described in the previous embodiment, or in other suitable ways.

Once the distal portion of the needle <NUM> is disposed within a vessel of the patient, the guidewire <NUM> is extended past the distal end of the needle and into the vessel by distally advancing the bottom housing portion 112B. Such advancement is achieved in the present embodiment by placing a user's fingers on the folded-up flaps <NUM> of the bottom housing portion 112B and pushing the flaps distally, thus extending the guidewire <NUM>. The guidewire <NUM> is advanced until fully extended. The lock out arm <NUM> of the needle hub <NUM> then engages the back plate <NUM> of the bottom housing portion 112B and prevents retraction of the guidewire <NUM>.

At this stage, the handle <NUM> of the catheter advancement assembly <NUM> is distally advanced, by a user grasping of one or both arms <NUM> thereof, so as to distally advance the catheter <NUM> through the insertion site and into the patient vasculature. This is shown in <FIG>, wherein the catheter tube <NUM> is shown distally advancing over the needle <NUM> and the guidewire122.

As shown in <FIG>, continued distal advancement of the catheter <NUM> causes the catheter hub <NUM> to urge the flaps <NUM> to open, thus providing a suitable opening through which the hub may pass from the insertion tool housing <NUM>. Note that the flaps <NUM> are shaped such that contact with the catheter hub <NUM> urges each flap to fold outward, as seen in <FIG>. Note also that the flaps <NUM> are no longer disposed within the track <NUM> due to full distal advancement of the guidewire <NUM> via finger pressure applied to the flaps <NUM> as described above.

<FIG> shows that, with the flaps no longer engaged within the track <NUM>, the top housing portion 112A and bottom housing portion 112B are able to separate at the distal ends thereof such that the handle <NUM>, still attached to the catheter hub <NUM>, can separate from the housing <NUM>. Though not shown at this stage, the needle safety component <NUM> disposed in the recess <NUM> of the handle <NUM> isolates the distal end of the needle <NUM>. The handle <NUM> can then be manually removed from the catheter hub <NUM> (<FIG>), and placement and dressing of the catheter <NUM> can be completed. The insertion tool <NUM>, including the needle <NUM> isolated by the needle safety component <NUM> of the handle <NUM>, can be safely discarded.

Reference is now made to <FIG> in describing a catheter insertion tool <NUM> according to one example, The insertion tool <NUM> includes a housing <NUM> defined by a top housing portion 212A and a bottom housing portion 212B that together partially enclose the catheter <NUM>. A sliding needle hub <NUM> supporting a distally extending hollow needle <NUM> is slidably attached to the housing <NUM>. In particular, the needle hub <NUM> includes tracks 214A that slidably engage corresponding rails <NUM> defined on the top and bottom housing portions 212A, 212B in a manner described further below. As shown in <FIG>, the needle hub <NUM> is positioned distally with respect to the housing <NUM> such that the needle <NUM> extends through a needle channel <NUM> (<FIG>) and out a hole defined in a distal end of the top housing portion 212A so that the needle is positioned as shown in <FIG>.

As seen in <FIG>, the housing <NUM> of the insertion tool <NUM> encloses a portion of the catheter <NUM>. An integrated guidewire/dilator <NUM> is included and disposed within the lumen of the catheter tube <NUM>, as shown in <FIG> and <FIG>. The guidewire/dilator <NUM> includes a distal guidewire portion 220A and a proximal dilator portion 220B. So configured, the guidewire/dilator <NUM> can not only serve as a guidewire in directing the catheter tube <NUM> through the insertion site of the patient into the accessed vessel, but can dilate the insertion site in advance of catheter insertion therethrough. In other embodiment, no guidewire/dilator need be used. In one example, it is appreciated that the guidewire/dilator <NUM> can proximally extend through the entire catheter <NUM> and include on a proximal end thereof a luer cap connectable to a proximal luer connector of the catheter. Note also that <FIG> shows a sterile bag <NUM> attached to the housing <NUM> so as to cover and isolate the proximal portion of the catheter <NUM>. For clarity, the bag <NUM> is included only in <FIG>, but could be included with insertion tools of varying configurations so as to protect and isolate portions of the catheter.

As seen in <FIG>, the needle <NUM> includes a longitudinally extending needle slot <NUM> extending from a beginning point along the length of the needle to the distal end thereof. <FIG> shows that the slot <NUM> can be optionally wider in a proximal portion thereof relative to more distal slot portions. So configured, the needle slot <NUM> enables the guidewire/dilator <NUM> to be inserted into, slid relative to, and removed from the needle <NUM> during operation of the insertion tool <NUM>, described below. Note that the needle slot can extend the entire length of the needle, in one example.

<FIG> shows the manner of entry of the guidewire/dilator <NUM> into the slot <NUM> of the needle <NUM> according to one example, wherein the guidewire/dilator extends distally along a guide channel <NUM> defined in the top housing portion 212A and into the hollow needle <NUM>, which is disposed in the needle channel <NUM>, via the needle slot. (The guide channel <NUM> is also seen in <FIG>. ) In this way, the guidewire/dilator <NUM> can be distally slid through the hollow needle <NUM> so as to extend beyond the distal needle end while still being able to be removed from the needle via the slot <NUM> when the guidewire/dilator and needle are separated from one another, as will be seen.

<FIG> also shows a support structure <NUM> for stabilizing the needle <NUM>, including an interface <NUM> defined by portions of the top housing portion 212A and the bottom housing portion 212B about the hole through which the needle extends. Of course, other support structures can be employed to provide stability to the needle to assist in inserting the needle into the patient vasculature. <FIG> shows details of a lockout <NUM> for the needle hub <NUM>, included on the bottom housing portion 212B, for preventing further movement of the needle hub after it has been retracted, as described below.

<FIG> depict various stages of use of the insertion tool <NUM> in inserting a catheter into a patient. With the insertion tool <NUM> in the configuration shown in <FIG>, vascular access is achieved with the needle <NUM> via user insertion of the needle into the patient at an insertion site.

Once the distal portion of the needle <NUM> is disposed within a vessel of the patient, the guidewire/dilator <NUM> is manually fed through the hollow needle <NUM> so as to extend past the distal end of the needle and into the vessel. Such advancement is achieved in the present embodiment by distally moving the housing <NUM> and catheter <NUM> together while keeping the needle hub <NUM> stationary. The guidewire <NUM> is advanced distally a suitable distance, which in the present example. includes advancement until a distal end of the housing <NUM> arrives at the skin insertion site.

<FIG> show that after the guidewire/dilator <NUM> has been distally extended into the vessel, the needle <NUM> is retracted from the vessel by proximally sliding the needle hub <NUM> along rail portions 218A disposed on the top housing portion 212A. Proximal sliding of the needle hub <NUM> continues until the hub engages the rail portions 218B of the bottom housing portion 212B and is fully slid to the proximal end of the housing <NUM>, as shown in <FIG>. The needle hub <NUM> engages the lock out <NUM> (<FIG>) so as to prevent future distal movement of the needle hub or needle <NUM>. In this position, the needle <NUM> is fully retracted into the insertion tool housing <NUM> such that the distal end of the needle is safely isolated from the user (<FIG>). Note that in one embodiment a needle safety component can be added to the insertion tool to further isolate the tip of the needle. Note that the distal portion of the guidewire/dilator <NUM> remains in the vessel of the patient, having been able to separate from the needle <NUM> during retraction thereof via the needle slot <NUM>.

At this stage, the bottom housing portion <NUM> (<FIG>) and the top housing portion 212A (<FIG>) are removed from the catheter <NUM>. The catheter <NUM> can then be inserted through the insertion site and into the vessel of the patient. Note that the guidewire/dilator <NUM> is still disposed within the catheter tube <NUM> and that the dilator portion assists the distal end of the catheter tube to enter the vessel by gradually enlarging the insertion site and the vessel entry point,.

As mentioned, in one example, the proximal portion of the catheter <NUM>, including the hub <NUM> and connected extension leg, is covered by a sterile bag, which is attached to the housing <NUM>. The sterile bag can be removed after the catheter is fully inserted into the patient vessel or can be removed when the housing portions 212A and 212B are removed. In <FIG>, the guidewire/dilator <NUM> is then removed from the catheter <NUM> and the catheter dressed and finalized for use. The guidewire/dilator <NUM> and other portions of the insertion tool <NUM> are discarded.

<FIG> depict details regarding a needle blunting system for isolating a distal end 316A of a hollow needle <NUM>, according to one example. As shown, the needle distal end 316A includes a bevel that is configured such that its cutting surfaces are disposed at an inner diameter <NUM> of the needle <NUM>. Thus, when a suitably sized guidewire <NUM> is distally extended past the distal end 316A of the needle <NUM>, the cutting surfaces of the needle are blocked by the proximity thereto of the guidewire, thus safely isolating the needle end from a user. In addition, blunting the distal end 316A of the needle <NUM> in this manner prevent the needle end from damaging sensitive inner walls of the vessel after the needle tip has been inserted herein. At this point, a distal end 44A of the catheter tube <NUM> can then be distally advanced over the needle <NUM> and guidewire <NUM>. <FIG> depicts a needle end bevel 316A according to another example, including an additional fillet component <NUM>. Such a blunting system can be employed in one or more of the insertion tools described herein.

Reference is now made to <FIG> in describing a catheter insertion tool <NUM> according to one example. The insertion tool <NUM> includes a housing <NUM> that partially encloses the catheter <NUM>. A distally extending hollow needle <NUM> is disposed with the housing <NUM> such that the needle extends out the distal end of the housing <NUM>.

A guidewire advancement assembly <NUM> is shown for selectively advancing a guidewire <NUM>, including a slide <NUM> that slides along a track <NUM> defined in the housing <NUM>. The guidewire <NUM> is attached to the slide <NUM> and extends proximally within the housing <NUM> until it bends, forming a guidewire bend 422A, toward the distal end of the housing and passes into the hollow needle <NUM> via a proximal end 416A thereof for selective distal advancement past the distal end of the needle via user actuation of the slide. Distal advancement of the guidewire <NUM> out the distal end of the needle <NUM> is stopped when the guidewire bend 422A engages the needle proximal end 416A.

A catheter advancement assembly <NUM> is also shown for selectively advancing the catheter tube <NUM> over the needle <NUM>, including a slide <NUM> that slides along the track <NUM>, and a carriage <NUM> disposed within the housing <NUM> and operably connected to the slide <NUM>. The carriage <NUM> is initially engaged with the catheter hub <NUM> such that distal sliding of the slide <NUM> causes the catheter to be distally advanced toward the distal housing end.

The insertion tool <NUM> further includes a support structure <NUM> for stabilizing the needle <NUM>, including two doors <NUM> hingedly attached via pins to the distal end of the housing <NUM>. The doors <NUM> serve to stabilize the needle <NUM> during insertion into the patient. Later, when the catheter tube <NUM> and catheter hub <NUM> are advanced distally by the slide <NUM>, the doors <NUM> are opened, enabling the catheter <NUM> to pass through the doors and be separated by the user from the insertion tool <NUM>. In the present example, a wedge feature is included on the bottom surface of the slide <NUM>, the wedge feature being configured to push the doors <NUM> open when the slide is slid distally, as described herein. Such a wedge or other suitable feature can be included in other embodiments described herein as well.

After separation from the insertion tool <NUM>, the catheter <NUM> can then be advanced and placed as needed into the patient by the user. Note that, though none is shown, a needle safety component can be included for isolating the distal tip of the needle <NUM>. In one example, distal sliding of the guidewire slide <NUM> can partially open the doors <NUM> in preparation for catheter advancement.

<FIG> shows the insertion tool <NUM> including a support structure <NUM> according to another example, wherein two half-conically shaped doors <NUM> are hingedly connected to the housing <NUM> (via living hinges or other suitable connective scheme) and configured to stabilize the needle <NUM>. The carriage of the insertion tool <NUM> in <FIG> is also longer relative to that of <FIG>. Thus, it is appreciated that various different support structures and configurations can be employed for stabilizing the needle at or near its exit point from the insertion tool housing.

Reference is now made to <FIG> in describing a catheter insertion tool <NUM> according to one example. The insertion tool <NUM> includes a housing <NUM> that partially encloses the catheter <NUM>. A hollow needle <NUM> distally extends from a needle hub <NUM> that caps a proximal end of the housing <NUM> such that the needle extends out the distal end of the housing <NUM>.

A guidewire advancement assembly <NUM> is shown for selectively advancing a guidewire <NUM>, including a slide <NUM> that slides along a track <NUM> defined in the housing <NUM>. The guidewire <NUM> is attached to the slide <NUM> and extends proximally within the housing <NUM> and out through a pigtail <NUM>, attached to the proximal end of the housing <NUM>, via a top one of two holes 514A defined in the needle hub <NUM>. Near the proximal end of the pigtail <NUM>, the guidewire <NUM> bends to form a U-shaped guidewire bend 522A and distally extends back into the housing <NUM> to pass into the hollow needle <NUM> via a bottom one of the two needle hub holes 514A, for eventual distal advancement out the distal end of the needle when the slide <NUM> is selectively actuated by a user. Such distal advancement of the guidewire <NUM> out the distal end of the needle <NUM> is stopped when the guidewire bend 522A abuts the holes <NUM>14A defined in the needle hub <NUM>.

A catheter advancement assembly <NUM> is also shown for selectively advancing the catheter tube <NUM> over the needle <NUM>, including a slide <NUM> that slides along the track <NUM>, and a carriage <NUM> disposed within the housing <NUM> and operably connected to the slide. The carriage <NUM> can be initially engaged with the catheter hub <NUM> such that distal sliding of the slide <NUM> causes the catheter to be distally advanced toward the distal housing end. In the present example a bulge 522B is included on the guidewire <NUM> such that, when the guidewire is distally advanced by user actuation of the (guidewire advancement) slide <NUM>, the bulge is advanced and engages an internal portion of the (catheter advancement) slide <NUM>. This in turn causes the slide <NUM> to be advanced as well, resulting in distal advancement of the catheter <NUM>. Thus, the catheter can be advanced directly via the slide <NUM>, or indirectly via the slide <NUM>, in one example.

The insertion tool <NUM> further includes a support structure <NUM> for stabilizing the needle <NUM>, including a plug <NUM> that includes a plug hole <NUM> defined therein through which the needle <NUM> extends. The plug <NUM> is attached via the track <NUM> to the slide <NUM> and occludes the distal end of the housing <NUM>, thus serving to stabilize the needle <NUM> that passes therethrough during needle insertion into the patient. Later, when the guidewire <NUM> is advanced distally by the slide <NUM>, the plug <NUM> also distally advances out the housing <NUM>, thus opening the housing distal end and enabling the catheter <NUM> to pass therethrough. The catheter <NUM> can then be separated by the user from the insertion tool <NUM><NUM> and advanced into final position by the user. Note that, though none is shown, a needle safety component can be included for isolating the distal tip of the needle <NUM>. Note also that after the plug <NUM> is removed from its initial position in the housing <NUM>, the catheter tube <NUM> and needle <NUM>, no longer being constrained by the support structure plug hole <NUM>, can axially relocate toward the center of the housing, in one example. This holds true for the examples of <FIG> and <FIG> as well.

Reference is now made to <FIG> in describing, a catheter insertion tool <NUM> according to one example. The insertion tool <NUM> includes a housing <NUM> that partially encloses the catheter <NUM>. A hollow needle <NUM> distally extends from a needle hub <NUM> that caps a proximal end of the housing <NUM> such that the needle extends out the distal end of the housing <NUM>. The needle <NUM> includes a longitudinally extending proximal slot 616A that extends from the proximal end of the needle <NUM> to a distal end 616B of the slot.

A guidewire advancement assembly <NUM> is shown for selectively advancing a guidewire <NUM>, including a slide <NUM> that slides along a track <NUM> defined in the housing <NUM>, The guidewire <NUM> is attached to the slide <NUM> and extends proximally within the housing <NUM> until it bends, forming a U-shaped guidewire bend 622A, toward the distal end of the housing and passes into the hollow needle <NUM> via the proximal slot 616A thereof for selective distal advancement past the distal end of the needle via user actuation of the slide. Note that distal advancement of the slide <NUM> causes the slide to separate from the housing <NUM> while still being attached to the guidewire <NUM>. Distal advancement of the guidewire <NUM> out the distal end of the needle <NUM> is stopped when the guidewire bend 622A engages the distal end 616B of the proximal slot 616A of the needle.

A catheter advancement assembly <NUM> is also shown for selectively advancing the catheter tube <NUM> over the needle <NUM>, including a carriage <NUM> disposed within the housing <NUM> and operably connected to the slide <NUM> such that actuation of the slide distally advances both the guidewire <NUM> and the carriage <NUM>. The carriage <NUM> is not initially engaged with the catheter hub <NUM>, but engages the hub after an amount of distal advancement. This in turn causes the catheter <NUM> to be distally advanced toward the distal housing end.

The insertion tool <NUM> further includes a support structure <NUM> for stabilizing the needle <NUM>, including a plug <NUM> that includes a plug hole <NUM> defined therein through which the needle <NUM> extends. The plug <NUM> is attached via the track <NUM> to the slide <NUM> and occludes the distal end of the housing <NUM>, thus serving to stabilize the needle <NUM> that passes therethrough during needle insertion into the patient. Later, when the guidewire <NUM> is advanced distally by the slide <NUM>, the plug <NUM> also distally advances out the housing <NUM>, thus opening the housing distal end and enabling the catheter <NUM> to pass therethrough. The catheter <NUM> can then be separated by the user from the insertion tool <NUM> and advanced into final position by the user. Note that, in one example, the carriage <NUM> can include a needle safety component for isolating the distal end of the needle <NUM>.

An advancement assembly <NUM> is shown for selectively advancing a guidewire <NUM> and catheter <NUM>. The advancement assembly <NUM> includes a wheel <NUM>, selectively rotatable by a user, that is attached via a filament <NUM> or other suitable component to a carriage <NUM>. The guidewire <NUM> is attached to the carriage <NUM> and extends proximally within the housing <NUM> and out through a pigtail <NUM>, attached to the proximal end of the housing <NUM>, via a one of two holes defined in the needle hub <NUM> (similar to the holes 514A in the needle hub <NUM> of <FIG>), Near the proximal end of the pigtail <NUM>, the guidewire <NUM> bends to form a U-shaped guidewire bend 722A and distally extends back into the housing <NUM> to pass into the hollow needle <NUM> via the other of the two holes defined in the needle hub <NUM> for eventual distal advancement out the distal end of the needle when the wheel <NUM> is selectively actuated by a user. Such distal advancement of the guidewire <NUM> out the distal end of the needle <NUM> is stopped when the guidewire bend 722A abuts the above-mentioned holes defined in the needle hub <NUM>.

The advancement assembly <NUM> selectively advances the catheter tube <NUM> over the needle <NUM> and includes the aforementioned carriage <NUM> disposed within the housing <NUM> and operably connected to the wheel <NUM> via the filament <NUM> such that rotation of the wheel distally advances the carriage <NUM>. The guidewire <NUM>, a proximal end of which being attached to the carriage <NUM>, is also advanced distally through the needle, as described above. Note that in one example the wheel <NUM>, by virtue of the non-rigid filament <NUM> connecting the wheel to the carriage <NUM>, ensures that the guidewire <NUM> is only distally advanced, and not proximally retractable.

Distal advancement of the carriage <NUM> causes the carriage - which is not initially engaged with the catheter hub <NUM> on to engage the hub after an amount of distal advancement. This in turn causes the catheter <NUM> to be distally advanced toward the distal housing end.

The insertion tool <NUM> further includes a support structure <NUM> for stabilizing the needle <NUM>, including a door <NUM> hingedly attached to the distal end of the housing <NUM> and including a hole <NUM> therein for enabling passage of the needle <NUM> therethrough. The door <NUM> serves to stabilize the needle <NUM> during insertion into the patient. Later, when the catheter tube <NUM> and catheter hub <NUM> are advanced distally by the wheel <NUM> and the carriage <NUM>, the door <NUM> is pushed open by the hub, enabling the catheter <NUM> to be separated by the user from the insertion tool <NUM>. The catheter <NUM> can then be advanced for final placement within the patient by the user. Note that, though none is shown, a needle safety component can be included for isolating the distal tip of the needle <NUM>.

Reference is now made to <FIG> in describing a catheter insertion tool <NUM> according to one example. The insertion tool <NUM> includes a housing <NUM> that at least partially encloses the catheter <NUM>. A hollow needle <NUM> distally extends from a needle hub <NUM> included within the housing <NUM> such that the needle initially extends out the distal end of the housing <NUM>. The needle <NUM> includes a distal slot 816A, similar to the previously described needle slot <NUM> (<FIG>), for enabling a guidewire/dilator <NUM>, similar to the previously described guidewire/dilator <NUM> (<FIG>) to be removably inserted therein. The catheter <NUM> is disposed over the guidewire/dilator <NUM>.

The needle hub <NUM> further includes a needle retraction system <NUM> for selectively retracting the needle <NUM> into the housing <NUM> so as to isolate the distal tip of the needle from the user in a safe manner. The retraction system <NUM> includes a spring <NUM> or other suitable retraction device operably coupled to the needle <NUM> for effecting the needle retraction.

An advancement assembly <NUM> is shown for selectively advancing the guidewire/dilator <NUM> as well as the catheter <NUM>. The advancement assembly <NUM> includes a slide <NUM> that travels in a track <NUM> defined in the housing <NUM>. The slide <NUM> is operably attached to a ratchet bar <NUM> slidably disposed within the housing <NUM>. The ratchet bar <NUM> includes a plurality of upper teeth <NUM> for selective catheter advancement, and at least one lower tooth 826A for actuating a retraction trigger <NUM> of the needle retraction system <NUM>, as will be described. The hub <NUM> of the catheter <NUM> disposed within the housing <NUM> has removably attached thereto a cap <NUM> including a prong <NUM> for engaging the upper teeth <NUM> of the ratchet bar <NUM>.

The insertion tool <NUM> further includes a support structure <NUM> for stabilizing the needle <NUM>, including a housing hole <NUM> defined by the distal end of the housing <NUM>. The housing hole <NUM> is sized to provide stability to the needle <NUM> at its point of exit from the housing.

<FIG> depict various stages of use of the insertion tool <NUM> in inserting a catheter into a patient. With the insertion tool <NUM> in the configuration shown in <FIG>, vascular access is achieved with the needle <NUM> via user insertion of the needle into the patient at an insertion site. Blood flashback can be observed via the distal slot 816A of the needle <NUM> to confirm proper positioning of the distal end of the needle within the patient's vessel. As shown in <FIG>, the slide <NUM> is slid distally to advance the guidewire/dilator <NUM>, a distal portion of which is pre-disposed within the needle <NUM> via the distal slot 816A, distally out the distal end of the needle and into the vessel of the patient. As shown, the guidewire/dilator <NUM> is advanced indirectly by the ratchet bar <NUM>, which is moved by the slide <NUM>. In particular, a proximate one of the upper teeth <NUM> of the ratchet bar <NUM> engages the prong <NUM> of the cap <NUM> fitted over the catheter hub <NUM>. Thus, when the slide <NUM> and ratchet bar <NUM> are moved distally, the catheter <NUM> and guidewire/dilator <NUM> disposed therein are also moved distally, as shown in <FIG>. Similar ratcheting movement occurs in the successive steps as well.

Sliding of the slide <NUM> in the stage shown in <FIG> also causes the bottom tooth 826A of the ratchet bar <NUM> to engage the retraction trigger <NUM> of the needle retraction system <NUM>. This in turn enables the spring <NUM> to expand and retract the needle <NUM> and retraction system <NUM> into the housing <NUM> such that the distal tip of the needle is isolated from the user within the housing.

<FIG> shows the return of the slide <NUM> to its initial position, which causes the ratchet bar <NUM> to also return to its initial position. Because the prong <NUM> of the cap <NUM> attached to the catheter hub <NUM> is distally angled, however, the teeth <NUM> of the ratchet bar slide past without retracting the catheter <NUM> such that the catheter remains in position.

In <FIG>, the slide <NUM> is again distally advanced, which causes a proximate upper tooth <NUM> of the ratchet bar <NUM> to engage the cap prong <NUM> and further advance the guidewire/dilator <NUM> distally into the vessel. As it is disposed over the guidewire/dilator <NUM>, the catheter <NUM> at this or a successive stage is also advanced into the vessel, depending on catheter length, distance to insertion site, etc. The slide <NUM> is subsequently retracted to its initial position, as shown in <FIG>. Note that ratchet retraction can be user activated or automatically activated by a suitable system included in the insertion tool <NUM>.

the slide <NUM> and ratchet bar <NUM> are again distally advanced, resulting in further distal advancement out of the housing <NUM> of the guidewire/dilator <NUM> and catheter <NUM>. The slide <NUM> is subsequently retracted to its initial position, as shown in <FIG>. In <FIG>, the slide <NUM> and ratchet bar <NUM> are distally advanced a final time, resulting in near-complete distal advancement of the guidewire/dilator <NUM> and attached catheter <NUM> from the housing <NUM> of the insertion tool <NUM>. At this stage, the hub <NUM> of the catheter <NUM> can be grasped and the catheter removed from the insertion tool <NUM>, which can then be discarded. Final positioning of the catheter <NUM> within the vessel can then be manually performed by the user. The cap <NUM> is also removed from the catheter hub <NUM>.

<FIG> depict details of a needle safety component for isolating the distal end 16A of the needle <NUM>, the needle including the distal notch <NUM> as discussed above in connection with <FIG>, according to one embodiment. As shown, a safety housing <NUM> including a hinged door is included so as to ride over the needle <NUM>. Two needle safety components <NUM> are oppositely disposed within the safety housing <NUM> and each also rides over the needle <NUM>. Each needle safety component includes a base <NUM> defining a hole through which the needle <NUM> passes and a plurality of arms <NUM>. The arms <NUM> extend from the base <NUM> and converge toward one another in conical fashion such that an end of each arm abuts the needle surface. The arms <NUM> are configured to engage the notch <NUM> defined in the distal portion of the needle <NUM> and prevent further movement of the needle <NUM> with respect to the needle safety component <NUM>. In particular, each arm <NUM> compressively engages the outer surface of the needle <NUM> such that when one of the arms encounters the needle notch <NUM>, the arm will descend into the notch slightly so as to lock the needle <NUM> in place with respect to the needle safety component <NUM>. Two needle safety components <NUM> are disposed in the safety housing <NUM> so as to prevent further needle movement in either direction, distally or proximally. Thus, the distal end 16A of the needle <NUM> is safely isolated within the safety housing <NUM>, as seen in <FIG>. Note that the needle safety component described here is useful for isolating a needle even when the guidewire <NUM> still extends therethrough, as seen in <FIG>, for example.

In other embodiments, only one needle safety component as described above may be used. Thus, the needle safety component described here serves as one example of a variety of needle safety components that may be employed in connection with the present disclosure.

It is appreciated that in one embodiment the insertion tool can include a sterile sheath or bag that is disposed over a distal portion of the catheter that distally extends from the insertion tool housing so as to isolate the catheter. The needle, pre-disposed within the catheter and retractable into the insertion tool housing, can extend from the bag to gain vascular access. Thereafter, the bag can be compressed toward the housing as the catheter is advanced into the vasculature, then disposed of once the catheter is fully inserted. In one embodiment, the bag can include a grip wing or other device that helps to grasp the catheter or needle through the bag during insertion. Further note that the insertion tools described herein can include a cap or other protective device that is removably attached to the insertion tool before use so as to preserve the sterility of the needle and catheter.

Claim 1:
An insertion tool for inserting a catheter into a body of a patient, comprising: a housing (<NUM>) in which at least a portion of the catheter (<NUM>) is initially disposed;
an at least partially hollow needle (<NUM>) distally extending from the housing, at least a portion of the catheter pre-disposed over the needle;
a guidewire (<NUM>) pre-disposed within the needle; and
an advancement assembly (<NUM>) for selectively advancing the guidewire distally past a distal end of the needle in preparation for distal advancement of the catheter,
wherein the housing includes a top housing portion (12A) and a bottom housing portion (12B) separably attached to one another, wherein the guidewire advancement assembly includes a user-actuated slide, and wherein distally sliding of the slide enables at least partial separation of the top and bottom housing portions.