Patent Description:
The present invention is directed to a catheter insertion tool.

In one embodiment, a catheter insertion tool according to the present invention is defined in claim <NUM>. The dependent claims define further features of further embodiments of the present 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.

A more detailed description of the present disclosure will be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings.

The embodiments shown in and described with reference to <FIG> and <FIG> are not encompassed by the wording of the claims but are considered useful for understanding the invention.

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". Unless specifically indicated otherwise, the word "initially" refers to the state of the insertion tool of the present invention when it is still in the assembled status as delivered to a health-care institution such as a hospital or clinic (or to a patient for use by the patient himself or herself or by the patient's personal care assistant) and has not been operated or used. Unless specifically indicated otherwise, "axial" or "axially" refers to the longitudinal direction of the insertion tool, which is also the orientation of the needle.

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 catheter 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 any length are possible. The catheter insertion tool in one embodiment integrates needle insertion, guidewire advancement, a needle distally extending from the housing and catheter insertion in a single device to provide for a catheter deployment procedure.

Reference is first made to <FIG> and <FIG>, which depict various details of a catheter insertion tool (also referred to "insertion tool" hereinafter), generally depicted at <NUM>, according to one embodiment. As shown in <FIG>, which is the perspective view of the insertion tool, the insertion tool <NUM> includes a housing <NUM> which in turn includes a first portion 12A and a second portion 12B.

In one embodiment, the first portion 12A of the housing <NUM> is separably engaged with a second portion 12B of the housing <NUM>. In one embodiment, the first portion 12A is able to be distally slide with respect to the second portion 12B to release the engagement. Details on the engagement and release will be provided later.

<FIG> is a top view of the cross section of the insertion tool. In one embodiment, as shown in <FIG>, the insertion tool <NUM> includes a rail <NUM> which is integral part of the housing <NUM> or is an independent element but fixated to the housing <NUM>. For example, the rail <NUM> can be an integral portion of the first portion 12A (as shown in <FIG>) of the housing <NUM> or the second portion 12B of the housing <NUM>, or be fixated to the housing <NUM> by molding or assembling.

The insertion tool <NUM> further includes a handle <NUM> for a clinician to stably hold the tool <NUM> while operating the tool. In one embodiment, the handle <NUM> extends from the rail <NUM>. In other embodiments, the handle <NUM> extends from the housing <NUM>, wherein the handle is disposed on the first portion 12A or the second portion 12B of the housing <NUM>. In one embodiment, one surface of the handle <NUM> includes small protrusions in order to increase the friction. In another embodiment, the surface of the handle <NUM> includes other structures that can increase the friction, for example, grooves, wales, frosted surface and so on. Such protrusions or similar structures on the surfaces of the handle <NUM> improve the operational stability when the user such as a clinician operates the insertion tool.

<FIG> and <FIG> are various exploded views of the insertion tool <NUM> of <FIG> and <FIG>. Reference now is made to <FIG>, where a needle hub 18A supporting a hollow needle <NUM> is placed between the housing portions 12A and 12B. The needle <NUM> extends distally form the needle hub 18A, through the body of the insertion tool <NUM> and out of a distal end of the housing <NUM>. In another embodiment, the needle <NUM> is at least partially hollow while still enabling the functionality described herein. In one embodiment, a notch 18B is defined through the wall of the needle <NUM> proximate the distal end thereof. The notch 18B 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 18B can be viewed by a clinician to confirm that the needle is properly inserted into the vasculature.

As shown in <FIG> and <FIG>, the insertion tool <NUM> further includes a catheter advancement assembly <NUM> for distally advancing a catheter <NUM> into the vasculature of the patient. The proximal end of the catheter <NUM> is connected to a catheter hub <NUM>. Both of the catheter <NUM> and catheter hub <NUM> are initially disposed on the needle <NUM>. And at least a portion of the catheter <NUM>, and the catheter hub <NUM>, are pre-disposed within the housing <NUM>. In one embodiment, a distal portion of the catheter <NUM> extends out of the distal end of the housing <NUM>. In one embodiment, the catheter hub <NUM> includes a handle extending out of the housing <NUM> from a slot 12C on the housing, and the handle of the catheter hub <NUM> can be used to effect the advancement of the catheter <NUM> and the catheter hub <NUM>. The slot 12C exists between the first portion 12A and the second portion 12B of the housing <NUM>, allowing the movement of the handle of the catheter hub <NUM>. In another embodiment, the handle of the catheter hub <NUM> is a branch pipe 24A extending from the catheter hub <NUM>. In another embodiment, a sterile protection is provided to the branch pipe.

Reference is continue made to <FIG> and <FIG>, where the insertion tool <NUM> includes a safety cap <NUM>. The safety cap <NUM> is initially attached to the catheter hub <NUM>, and can be separated from the catheter hub <NUM> when it is distally slid to a certain position. In one embodiment, the safety cap <NUM> is locked to the housing <NUM> when sliding to the position. Details on this locking mechanism are to be described below.

In one embodiment, the safety cap <NUM> includes a first portion 26A wrapping the needle and a second portion 26B slidably attached to the rail <NUM>. In one embodiment, the position where the catheter hub <NUM> and the safety cap <NUM> can be separated is a position where the tip of the needle <NUM> is isolated within the first portion 26A of the safety cap <NUM>. In one embodiment, the second portion 26B of the safety cap <NUM> is locked to the rail <NUM> when the safety cap <NUM> slides to the position that the tip of the needle <NUM> is isolated within the first portion 26A of the safety cap <NUM>. The locking between the safety cap <NUM> (more specifically the second portion 26B) and the rail <NUM> prevents the relative movement between the safety cap <NUM> and the needle <NUM>, avoiding the re-exposure of the needle tip and thus eliminating the possibility that the needle pricks the clinician or the patient.

Referring to <FIG>, in one embodiment, the insertion tool <NUM> further includes at least one septum <NUM> to prevent blood exposure while the needle and catheter is inserted into or withdrawn from the body of the patient. There can be one or multiple septa placed inside the insertion tool <NUM>. In one embodiment, a septum28 (not shown in <FIG>) is disposed within the lumen of the catheter hub <NUM>. In one embodiment, a septum <NUM> is disposed on the first portion 26A of the safety cap <NUM>. In one embodiment, a septum <NUM> is disposed within the lumen of the first portion 26A of the safety cap <NUM>. To be noted, a septum can also be disposed inside another element of the insertion tool, for example, the branch tube of the catheter hub <NUM>. The size and shape of a septum is configured to fit the corresponding element or a lumen of the element, and when multiple septa are used the size and shape of each septa can be the same or different.

Referring back to <FIG>, in one embodiment, the insertion tool <NUM> comprises a guidewire advancement assembly <NUM> for distally advancing a guidewire <NUM> into, or withdrawing it from, the vasculature of the patient. In one embodiment, the guidewire advancement assembly <NUM> further includes a pusher <NUM> for operating the movement of the guidewire <NUM> in preparation for the advancement of the catheter <NUM>.

In one embodiment, at least a portion of the guidewire <NUM> is disposed within the lumen of the needle <NUM>. In an alternative embodiment, the distal end of the guidewire <NUM> is initially dispose within the tip of the needle <NUM>, while the other end of the guidewire <NUM> is fixated to an anchor point on the housing <NUM> or the rail <NUM>. The guidewire <NUM> proximally extends from the anchor point, enters a hole <NUM> disposed on the pusher <NUM> and is bended by the hole <NUM>, extends away from the hole <NUM> and distally extends into the lumen of the needle <NUM>. In one embodiment, the movement of the pusher <NUM> applies a friction force on the bended portion of the guidewire <NUM>, so as to advance or retract the distal portion of the guidewire <NUM>. When the pusher <NUM> is distally moved, the guidewire <NUM> is distally advanced over a distance two times the moving distance of the pusher <NUM>. This conveniently increases the efficiency of guidewire advancement, which is desired in the operation of such a medical device.

<FIG> and <FIG> are side views of a housing <NUM> of the catheter insertion tool of the present invention. The housing <NUM> includes a first portion <NUM> comprising a distal part 42A and a proximal part 42B, and a second portion <NUM> engaged with the first portion <NUM>, wherein the distal part 42A of the first portion <NUM> is configured to be able to distally slide with respect to the second portion <NUM> to release the engagement <NUM> between the first portion <NUM> and the second portion44.

In one embodiment, the proximal part 42B of the first portion42 is fixated to the second portion <NUM>. Alternatively, the proximal part 42B of the first portion <NUM> is engaged with the second portion <NUM> via a separable configuration, for example a snap-fit joint, pin joint, rivet joint, buckle and so on. A force above a threshold magnitude is required to release the separable engagement between the proximal part 42B of the first portion <NUM> and the second portion <NUM>, so as to prevent accidental separation of the housing. In another embodiment, the proximal part 42B of the first portion <NUM> and the second portion <NUM> are inseparable from each other or form an integrated piece.

In one embodiment, as shown in <FIG> and <FIG>, a hook 46A is disposed on an inner surface of the distal part 42A of the first portion <NUM> of the housing. The hook 46A has a tip extending toward the proximal end of the housing <NUM>. A slot 46B is disposed on the second portion <NUM>. The slot 46B receives the hook 46A when the first portion <NUM> and the second portion <NUM> are engaged, and the hook 46A is released from the slot 46B when the distal part 42A of the first portion <NUM> is slide distally such that the first portion <NUM> is released from the second portion <NUM>.

Refers back to <FIG>, the first portion <NUM> and the second portion <NUM> of the housing <NUM> are engaged with each other through the engagement <NUM> formed by the hook 46A and slot 46B and the engagement between the proximal part 42B of the first portion <NUM> and the second portion <NUM>. In the direction pointed by the arrow, the distal part 42A of the first portion <NUM> can be distally slid with respect to the second portion <NUM> of the housing <NUM>. The distal sliding of the distal part 42A of the first portion <NUM> results in the distal movement of the hook 46A with respect to the hole 46B. When the tip of the hook 46A reaches the position as shown in <FIG>, the hook 46A can be separated from the hole 46B, such that the engagement <NUM> is released and the distal part 42A of the first portion <NUM> and the second portion <NUM> can be separated in a perpendicular direction with respect to each other.

To be noted, while <FIG> only show one pair of hook 46A and hole 46B, in one embodiment, the housing <NUM> of the present invention includes two hooks and two holes. To better stabilize the engagement <NUM>, as an optimal embodiment, two hooks are arranged in parallel on the inner surface of the distal part 42A and, correspondingly, two holes are arranged on the second portion <NUM> in the same way as the two hooks. Other numbers and arrangement of the hooks and the holes are possible.

As shown in <FIG> and <FIG>, in one embodiment, a base <NUM> is disposed on an inner surface of the second portion <NUM> of the housing <NUM> for holding the proximal end of a needle <NUM>. The proximal end of the needle <NUM> is fixated to the hosing. In one embodiment, the base <NUM> includes a hole allowing the guidewire to extend into the lumen of the needle <NUM> via the hole.

As shown in <FIG>, in one embodiment, a groove <NUM> is disposed on an inner surface of at least one of the first and second portions <NUM>/<NUM>, the groove <NUM> having an inner width which is wide enough to allow free movement of the catheter in an axial direction and narrow enough to restrict the movement of the catheter perpendicular to the axial direction. That is, the first and second portions of the housing when engaged with each other provides supporting for the distal portion of the needle <NUM> which limits the swing of the needle <NUM> while the needle <NUM> is being inserted into or withdrawn from a patient's body.

In one embodiment, the distal part 42A and the proximal part 42B are always connected to each other before or after the distal movement of the distal part 42A. The connection can be formed by an elastic, or foldable, or hinged connection. Examples of an elastic or foldable connection can be a hinge, spring or another flexible piece.

In another embodiment, the distal part 42A of the first portion <NUM> can be separated from the second portion <NUM> after the distal part is distally slid to release the engagement between the first portion <NUM> and the second portion <NUM>.

Continually refer to <FIG>. In another embodiment, the proximal end of the distal part 42A of the first portion <NUM> includes a structure <NUM> which is clamped between the proximal part 42B of the first portion <NUM> and the second portion <NUM>, movement of the structure <NUM> being limited within a cavity formed by the proximal part 42B of the first portion <NUM> and the second portion44. Specifically, in one embodiment, the structure <NUM> includes a flexible sheet 49A extending proximally from the proximal end of the distal part 42A, and two walls 49B vertically extending from two sides of the end portion of the flexible sheet 49A. In one embodiment, after the distal part 42A is distally slid over a certain distance, the structure <NUM> is blocked by the base <NUM> so as to prevent further distal movement of the distal part 42A of the first portion <NUM>. The certain distance is also the distal movement distance of the hook 46A that allows the hook 46A to be released from the hole <NUM>.

In one embodiment, the sheet 49A and the two walls 49B of the structure <NUM> of the distal part 42A engage with a ridge extending from the base <NUM>. The ridge acts like a rail for the structure <NUM>, which allows a distal movement along the ridge, but also restricts the swing of the structure <NUM> during the distal movement.

In one embodiment, the structure <NUM> is clamped by the base <NUM> of the second portion <NUM> and the inner surface of the proximal part 42B of the first portion <NUM>. This prevents the distal part 42A from being detached from the rest of the housing, and allows the open-close movement of the distal part 42A with respect the second portion <NUM> with an angle. Such a mechanism avoids the housing form falling apart after use, which is good for medical safety (for example, prevention of needle stick and/or blood contamination) and user experience.

<FIG> are side views of a housing <NUM> of the catheter insertion tool of the present invention. As shown in <FIG>, the housing <NUM> includes a first portion <NUM> comprising a distal part 52A and a proximal part similar to the proximal part 42B shown in <FIG> and <FIG>, and a second portion <NUM> engaged with the first portion <NUM>. The proximal end <NUM> of the distal part 52A of the first portion <NUM> is configured to be able to be axially locked to the second portion <NUM>, and the distal part 52A of the first portion <NUM> is configured to be able to distally slide with respect to the second portion <NUM> when the locking between the proximal end <NUM> of the distal part 52A of the first portion <NUM> and the second portion <NUM> is released, so as to release the engagement <NUM> between the first portion <NUM> and the second portion <NUM>.

Reference continues to be made to <FIG>, where in one embodiment, as shown in the partially enlarged view "A", a first protrusion 56A extends from the proximal end <NUM> of the distal part 52A toward the second portion <NUM>, and a second protrusion 56B extends from the second portion <NUM> toward the proximal end <NUM> of the distal part 52A of the first portion <NUM>. In <FIG>, the proximal end <NUM> of the distal part 52A of the first portion <NUM> is flexible and is biased (by a slider58 for example) toward the second portion <NUM>, and the first protrusion 56A is proximal relative to the second protrusion 56B, whereby the proximal end <NUM> of the distal part 52A of the first portion <NUM> is axially locked to the second portion <NUM> such that the first portion <NUM> cannot be axially and distally moved relative to the second portion <NUM>.

<FIG> is the side view of the distal part 52A of the first portion <NUM> of the housing shown in <FIG>. The proximal end <NUM> of the distal part 52A shown in <FIG> is in a natural, unbiased state, and it is in the form of a bevel slightly tilting upwards proximally. The bevel may have a consistent thickness. Alternatively the thickness of the bevel may gradually increase or decrease distally, with the least or greatest thickness reached at the location of the first protrusion 56A (without accounting for the height of the first protrusion 56A itself). The bevel having such a varying thickness may help change the amount of the force the slider <NUM> imposes on the bevel and the friction between the slider <NUM> and the bevel.

<FIG> is the side view of the housing <NUM> when the locking between the proximal end <NUM> of the distal part 52A of the first portion <NUM> and the second portion <NUM> is released. In one embodiment, when the slider <NUM> is moved distally, the force the slider <NUM> imposes on the proximal end <NUM> of the distal part 52A of the first portion <NUM> decreases and the proximal end <NUM> is gradually unbiased, and accordingly the first protrusion 56A moves upward relative to the second protrusion 56B. When the slider <NUM> is distally moved to a certain position as shown in <FIG>, the first protrusion 56A moves up to reach a position where the second protrusion 56B no longer blocks the distal movement of the first protrusion 56A and thus the locking between the proximal end <NUM> of the distal part 52A of the first portion <NUM> and the second portion <NUM> is released.

Similar to the housing <NUM> in <FIG>, in one embodiment as shown in <FIG> and <FIG>, a hook 46A is disposed on an inner surface of the distal part 52A of the first portion <NUM> of the housing <NUM>, and a slot 46B is disposed on the second portion <NUM> of the housing <NUM> in a position corresponding to the hook 46A. The hook 46A may be in a form of first perpendicularly protruding from the inner surface of the distal part 52A of the first portion <NUM> of the housing <NUM> and then extending horizontally and proximally, as shown in <FIG>. The slot 46B receives the hook 46A when the first portion <NUM> and the second portion <NUM> are engaged, and the hook 46A is released from the slot 46B when the locking between the proximal end <NUM> of the distal part 52A of the first portion <NUM> and the second portion <NUM> is released and the distal part 52A of the first portion <NUM> is slide distally, such that the first portion52 can be released from the second portion <NUM>.

<FIG> is the side view of the insertion tool showing the state when the engagement between the distal part 52A of the first portion <NUM> and the second portion <NUM> is released. In one embodiment, the proximal end <NUM> of the distal part 52A of the first portion <NUM> includes a structure 56C which is clamped between the proximal part (not shown in <FIG>) of the first portion <NUM> and the second portion <NUM>, and movement of the structure 56C is limited within a cavity formed by the proximal part of the first portion <NUM> and the second portion <NUM>. Specifically, in one embodiment, the structure 56C is similar to the structure <NUM> as shown in <FIG>. In one embodiment, after the distal part 52A is distally slid over a certain distance, the structure 56C is blocked by the base <NUM> so as to prevent further distal movement of the distal part 52A of the first portion <NUM>, wherein said certain distance is also the distal movement distance of the hook 46A that allows the hook 46A to be released from the slot 46B.

Such a locking mechanism between the proximal end <NUM> of the distal part 52A of the first portion <NUM> and the second portion <NUM> can effectively prevent a clinician's inadvertent operation which may cause distal movement of the distal part of the first portion of the housing and thus prevent unwanted separation of the housing. Additionally, in one embodiment, besides releasing the axial locking between the distal part 52A of the first portion <NUM> and the second portion <NUM>, the distal movement of the slider <NUM> is also configured to advance the guidewire simultaneously, and such a configuration increases the operational efficiency and safety.

<FIG> and <FIG> shows the inner structure of one embodiment of the insertion tool <NUM> of the present invention. Specifically, <FIG>is a top view of the insertion tool <NUM> without the first portion 12A of the housing <NUM>. In one embodiment, the insertion tool <NUM> of the present invention includes a housing <NUM>, a rail <NUM> attached to the housing, a needle <NUM> distally extending from the housing <NUM>, a catheter advancement assembly <NUM>, a guidewire advancement assembly <NUM>, wherein the catheter advancement assembly <NUM> includes a catheter <NUM>, a catheter hub <NUM> and a safety cap <NUM> which is separably attached to the catheter hub <NUM>.

Further to the status shown in <FIG>, <FIG> shows the safety cap <NUM> distally sliding to a position where the safety cap <NUM> is locked to the rail <NUM>. In one embodiment, the safety cap <NUM> is configured to be locked to the housing <NUM> when distally sliding to a position of isolating the tip of the needle <NUM> within the safety cap <NUM>. To be noted, since the rail <NUM> is a part of the housing or is fixated (attached) to the housing, when the safety cap <NUM> is locked to the rail <NUM>, the safety cap <NUM> is also to be considered being locked to the housing <NUM>. <FIG> clearly shows the position that the safety cap <NUM> is locked to the housing and the needle tip is isolated within the safety cap <NUM>. At this position, the relevant movement between the safety cap <NUM> and the needle <NUM> is restricted, so as to prevent the re-exposure of the needle tip.

<FIG> shows the view that the catheter hub <NUM> is separated from the safety cap <NUM> when the safety cap <NUM> is at the position as described in <FIG>.

As shown in <FIG> and <FIG>, in one embodiment, the safety cap <NUM> is locked to the housing <NUM> at a location <NUM> and the tip 18C of the needle <NUM> is isolated within the safety cap <NUM> when the safety cap <NUM> slides to the position of isolating the tip 18C of the needle within the safety cap.

<FIG> shows the structure of the safety cap <NUM> of one embodiment of the present invention. The safety cap <NUM> includes a first portion 26A and a second portion 26B. Viewed in combination with <FIG>, <FIG> and <FIG>, in one embodiment, the first portion 26A of the safety cap <NUM> wraps the needle <NUM> and the second portion 26B of the safety cap <NUM> is slidably attached to a rail <NUM>. Specifically, in one embodiment, the first portion 26A of the safety cap <NUM> includes a lumen 27extendingthrough the first portion 26A which contains and wraps the needle <NUM>.

In one embodiment, the first portion 26A of the safety cap <NUM> has two fingers <NUM>. In one embodiment, the two fingers <NUM> have a slit between them which wraps the needle <NUM>. In another embodiment, three, four or even more fingers are possible. In another embodiment, the fingers <NUM> are in the shape of a strip or column.

<FIG> and <FIG> shows the engagement between the catheter hub <NUM> and the safety cap <NUM> of one embodiment of the present invention. The engagement is formed by inserting a protrusion <NUM> on the fingers <NUM> into a recess <NUM> disposed on the catheter hub <NUM>.

Referring to <FIG>, in one embodiment, the fingers <NUM> are configured to be biased radially toward an inner surface of the catheter hub <NUM> when the stem of the needle <NUM> extends through the first portion 26A of the safety cap <NUM>. That is, when the first portion 26A of the safety cap <NUM> wraps the needle stem, the fingers <NUM> are slightly biased/pressed outward by the needle <NUM>. The radially biased fingers <NUM> insert their protrusion <NUM> into the recess <NUM>, and the pressure from the needle <NUM> helps secure the insertion of the protrusion <NUM> into the recess <NUM>, thus realizing the engagement between the catheter hub <NUM> and the safety cap <NUM>.

Referring to <FIG>, in one embodiment, the fingers <NUM> are configured to be released from the biased position when the safety cap <NUM> distally slides to the position of isolating the tip of the needle <NUM>. That is, when losing the pressure from the needle, the fingers <NUM> converge towards the axis of lumen of the catheter hub <NUM>, and the protrusion <NUM> can be pulled out of the recess <NUM> and thus the catheter hub <NUM> can be separated from the safety cap <NUM>.

Referring to <FIG>, in one embodiment, the fingers <NUM> are configured to remain in the same position when the stem of the needle extends through the first portion 26A of the safety cap <NUM> and when the safety cap <NUM> distally slides to the position of isolating the tip of the needle. That is, the fingers <NUM> are kept at the same position and basically are not biased with or without the pressure from the needle <NUM>. And the outer diameter of the hollow cylinder formed by the fingers do not change whether the needle extends through the hollow cylinder or not. Nonetheless, the pressure from the needle <NUM> facilitates the insertion between the protrusion <NUM> and the recess <NUM>.

Referring to <FIG>, in one embodiment, when losing the pressure from the needle, the fingers <NUM> are kept at the same position as biased/pressed by the needle <NUM>. In this situation, when a user of the insertion tool tries to pull the safety cap <NUM> away from the catheter hub <NUM>, the protrusion <NUM> is pulled out of the recess <NUM>.

In one embodiment, each of the fingers <NUM> includes a protrusion <NUM>, and a corresponding number of recesses <NUM> are disposed on the inner surface of the catheter hub. In one embodiment, each of the fingers <NUM> can include one or more protrusions <NUM>.

Reference is now made to <FIG>. The proximal side of the protrusion <NUM> forms an obtuse angle relative to the surface of the finger <NUM> where the proximal side extends from the finger <NUM>. That is, the proximal side of the protrusion <NUM> is a slope which allows the protrusion <NUM> to be pulled out from the recess <NUM> when the fingers <NUM> are not biased/pressed by the needle <NUM>.

Referring to <FIG>, the second portion 26B of the safety cap <NUM> is a lever81, which slides along the rail <NUM>. In one embodiment, the lever 81includes two vertical walls 82vertically extending from the two sides of a surface <NUM> of the lever <NUM> facing the rail <NUM>. Each of the two vertical walls <NUM> has a horizontal part with a protrusion <NUM>, which protrusion is locked within a notch <NUM> formed on the rail <NUM> so as to lock the safety cap <NUM> to the housing <NUM> when the safety cap <NUM> distally slides to the position of isolating the tip of the needle <NUM> within the safety cap <NUM>.

To clearly depict the structure of the lever <NUM>, reference is made to <FIG>, which is a sectional view of a plane perpendicular to the axis of the lumen of the safety cap <NUM>. In one embodiment, the surface <NUM> of the lever facing the rail <NUM> includes two vertical walls <NUM>, and the lever <NUM> is connected to the first portion 26A of the safety cap <NUM> on the opposite side of the surface <NUM>. Each of the two vertical walls <NUM> has a horizontal part with a protrusion <NUM>. Here the horizontal part is basically parallel to the surface <NUM>, and in one embodiment, the vertical walls <NUM> extends throughout the full length of the lever, and the horizontal part is shorter than the full length of the lever. In another embodiment, the vertical walls <NUM> extend over only a partial length of the lever, and the horizontal part is shorter than the length of the vertical walls <NUM>.

As shown in <FIG>, in one embodiment, the notch <NUM> is formed between two prominent bumps 88A and 88B disposed on the rail. In another embodiment, the proximal bump 88A has an inclined slope 88C at the proximal side and is substantially vertical to the surface of the rail at the distal side. In one embodiment, the distal bump 88B is raised higher from the surface of the rail <NUM> than the proximal bump 88A. While the protrusions <NUM> slide over the inclined slope 88C of the proximal bump 88A, the distance between the two protrusions <NUM> of the lever increases along the inclined slope 88C and the tension between the two protrusions <NUM> also gradually increases. When the protrusions <NUM> fall into the notch formed by the prominent bumps 88A and 88B, further movement of the protrusions <NUM> is blocked by the proximal side of the prominent bump 88B and distal side of the prominent bump 88A, and thus the safety cap <NUM> is locked to the rail <NUM>.

In one embodiment, a user of the insertion tool (e.g. a clinician) feels a tactile sensation when the safety cap <NUM> is locked to the housing <NUM>, for example when the protrusions <NUM> of the lever fall into the notch <NUM>. In one embodiment, an audible sound is produced besides the tactile sensation.

Referring to <FIG>, in one embodiment, the insertion tool includes at least one septum <NUM> to prevent blood exposure while the needle is inserted and the catheter is advanced into or away from the body of the patient. In one embodiment, the septum <NUM> can be disposed in a lumen within the insertion tool. For example, the septum <NUM> can be placed in a lumen of the catheter hub <NUM> of the insertion tool, and/or can be placed in a lumen of the safety cap <NUM> of the insertion tool.

In one embodiment, a septum <NUM> is disposed within the lumen of the catheter hub <NUM>. In one embodiment, a septum <NUM> is disposed in the first portion 26A of the safety cap <NUM>. In one embodiment, a septum <NUM> is disposed within the lumen of the first portion 26A of the safety cap <NUM>. To be noticed, the septum can also be disposed in other element of the insertion tool, for example, the branch tube of the catheter hub <NUM>. The size and shape of the septum <NUM> is configured to fit the corresponding element or lumen of the element, and the size and shape of each septa can be the same or different.

<FIG> shows a septum <NUM> of one embodiment of the present invention. Referring to <FIG>, in one embodiment, the septum90 comprises a cylindrical main body <NUM>, and a first protrusion <NUM> which extends from a central portion of a top surface 94A of the main body <NUM>. In one embodiment, the thickness of the cylindrical main body <NUM> is configured to be smaller than the distance between the tip and the notch of the needle <NUM>, so as to reduce the friction between the septum <NUM> and the needle <NUM>.

As shown in <FIG>, the septum <NUM> has a slit <NUM> formed within the septum <NUM> along the longitudinal axis of the septum. In one embodiment, the slit <NUM> is formed within the first protrusion. In one embodiment, the slit <NUM> extends through the septum. Specifically, the slit <NUM> can extend partially or entirely through the cylindrical main body <NUM> and the protrusion. In one embodiment, the slit <NUM> is enlarged when a needle <NUM> extends through it and is closed when the needle <NUM> is withdrawn from the septum <NUM>. When the needle punctures the entire septum, the slit <NUM> consequentially extends throughout the septum. As a preferred embodiment, to ensure the sealing performance of the septum <NUM>, the slit <NUM> initially is not through the entire thickness of the septum <NUM>, and thus when the needle punctures the septum <NUM> during the assembling process, the septum <NUM> will tightly wrap the needle and provide a tight seal around the needle. As another embodiment, the septum <NUM> is formed without a through slit, and when the needle punctures the septum <NUM>, the septum <NUM> tightly wraps the needle and may provide a tighter seal around the needle than a configuration with a slit does (assuming the configuration is the same in all the other aspects).

In one embodiment, the outer diameter of the main body <NUM> of the septum <NUM> is slightly larger than the inner diameter of the lumen of the catheter insertion tool before the septum <NUM> is installed in the lumen. Specifically, the outer diameter of the main body <NUM> of the septum <NUM> is larger than the inner diameter of the catheter hub <NUM>. When the septum <NUM> is assembled in the lumen of the catheter hub <NUM>, the inner surface of the catheter hub <NUM> is in tight contact with the septum <NUM> and thus provides better sealing.

In one embodiment, the first protrusion <NUM> of the septum is in the form of a circular truncated cone tapering from the top surface 94A of the main body <NUM> as shown in <FIG>. And the circular truncated cone is coaxial with the main body <NUM>. In one embodiment, the first protrusion <NUM> is integral with the main body <NUM>.

In one embodiment, the top surface 94A of the septum <NUM> is rounded at the peripheral. In one embodiment, the top surface of the circular truncated cone is rounded at the peripheral.

In one embodiment, the septum <NUM> of the present invention further includes a second protrusion <NUM> which extends from a central portion of the bottom surface 98A of the main body <NUM> opposite to the top surface 94A.

In one embodiment, the second protrusion <NUM> is in the form of a circular truncated cone tapering from the bottom surface 98A as shown in Figures 9A and 9B. And the circular truncated cone is coaxial with the main body <NUM>. In one embodiment, the second protrusion <NUM> is integral with the main body <NUM> and forms an integrated body. In another embodiment, the second protrusion <NUM> is in the form of a cylinder embedded in the central of the main body <NUM>. In another embodiment, the first protrusion <NUM> and the second protrusion <NUM> forms a cylinder embedded in the central of the main body <NUM>. In one embodiment, the slit <NUM> partially extends in the cylinder formed by the first protrusion <NUM> or the second protrusion <NUM>. In another embodiment, the slit <NUM> extends throughout the cylinder.

In one embodiment, the first and the second protrusion are the same in size and shape. In another embodiment, the second protrusion <NUM> is lower than the first protrusion <NUM>. When the lumen of the catheter hub <NUM> is full of fluid (e.g. blood) at a side of the septum <NUM>, the side surface of the first or the second protrusion facing the fluid assumes the centripetal pressure from the fluid and wraps the needle more tightly when a needle extends through the septum or shuts the slit more tightly if a slit has been formed through the septum, thus providing better fluid sealing.

<FIG> and <FIG> show a septum <NUM> assembled in the catheter hub <NUM>. In one embodiment, as shown in <FIG> the septum <NUM> is disposed at the distal end of a lumen <NUM> of the catheter hub <NUM>, which lumen is to accept the safety cap <NUM>. The lumen <NUM> has a step 101A where the inner diameter of the lumen <NUM> drops distally. Proximal to the step 100A, the outer diameter of the main body <NUM> of the septum <NUM> is big enough to provide a fluid-sealing contact with the inner surface of the lumen <NUM> of the catheter hub <NUM>. Distal to the step 101A, the first protrusion <NUM> of the septum <NUM> extends into the lumen <NUM> distal to the step 101A. To be understood, the septum can also be disposed in other positions within the lumen <NUM> of the catheter hub <NUM>. In another embodiment as shown in <FIG>, the septum <NUM> is sandwiched between two steps 101A and 101B formed in the inner surface of the lumen <NUM> of the catheter hub <NUM>.

In one embodiment, the septum <NUM> is made of polyisoprene, silicone rubber, polyurthane, butyl rubber or latex.

<FIG> and <FIG> show a septum100 of one embodiment of the present invention. Referring to <FIG>, in one embodiment, the septum <NUM> comprises a circular end portion <NUM> and a tubular portion <NUM> extending from the peripheral of the end portion <NUM>. In one embodiment, the septum <NUM> is in the shape of a tubular with a close end (circular end portion <NUM>) at the distal end of the septum <NUM> and an open end at the proximal end of the septum <NUM>. Specifically, in one embodiment, the end portion <NUM> is a rounded thin film, and the tubular portion <NUM> extends from the perimeter of the film in a direction perpendicular to the plane of the end portion <NUM>.

In one embodiment, the septum <NUM> further includes a protrusion <NUM> extending from a central portion of a surface of the circular end portion <NUM> opposite to the tubular portion <NUM>. In one embodiment, the protrusion <NUM> is in the form of a cylinder. In another embodiment, the protrusion <NUM> is in the form of a circular truncated cone tapering from the bottom surface. The protrusion <NUM> is coaxial with the circular end portion <NUM>. In one embodiment, the protrusion <NUM>, the circular end portion <NUM> and the tubular portion <NUM> form an integral piece.

Similar to the septum <NUM>, the end portion <NUM> of the septum <NUM> can be formed with or without a slit.

<FIG> shows the septum <NUM> assembled on the distal portion of the safety cap <NUM>. In one embodiment, the septum <NUM> is disposed on the fingers of the safety cap <NUM>, wherein the sidewall of the tubular portion <NUM> includes at least one recess <NUM> which allows the protrusions disposed on the fingers to extend through the recess <NUM>. In one embodiment, the number and position of the recesses <NUM> disposed on the tubular portion <NUM> correspond to the number and position of the protrusion disposed on the fingers of the safety cap <NUM>. As mentioned above, the fingers of the safety cap are separated from each other in the distal portion of the fingers, and are configured to be biased radially when wrapping the needle and to be converged centrally when the needle is pulled out therefrom. The septum <NUM> is configured to cap/cover the fingers so as to provide a sealing to prevent blood from leaking from the fingers of the safety cap.

Moreover, when the fingers <NUM> of the safety cap <NUM> are fully or partially inside the lumen <NUM> of the catheter hub <NUM>, for example as shown in <FIG>, <FIG> or <FIG>, the septum <NUM> disposed on the fingers <NUM> enhances the sealing between the safety cap <NUM> and the catheter hub <NUM>. And the septum <NUM> provides an appropriate friction between the safety cap <NUM> and the catheter hub <NUM>, and the friction requires the user/clinician to apply a force to separate the catheter hub <NUM> and the safety cap <NUM> when the safety cap <NUM> slides to a locking position that the needle tip is isolated within the safety cap.

In addition, as another embodiment, the septum <NUM> disposed on the fingers of the safety cap <NUM> and the septum <NUM> disposed in the lumen <NUM> of the catheter hub <NUM> contacts each other when the safety cap <NUM> and the catheter hub <NUM> are connected. Specifically, in one embodiment, the main body <NUM> or protrusion <NUM>/<NUM> of the septum <NUM> is in tight contact with the protrusion <NUM> or end portion <NUM> of the septum <NUM> when the finger portion of the safety cap <NUM> is fully inserted into the lumen <NUM> of the catheter hub <NUM>. Such a configuration can prevent blood leaking while the needle tip passes through the septa <NUM> and <NUM>, and accordingly prevent blood exposure when the safety cap <NUM> and the catheter hub <NUM> are separated from each other.

In one embodiment, as shown in <FIG>, the catheter insertion tool <NUM> further includes a septum <NUM> disposed in the lumen of the first portion 26A. Specifically, as an embodiment, the septum <NUM> is in the shape of a cylinder. In one embodiment, the thickness of the septum <NUM> is configured to be smaller than the distance between the tip and the notch of the needle <NUM>, so as to reduce friction between the septum <NUM> and the needle <NUM>.

Similar to the septum <NUM>, septum <NUM> can be formed with or without a slit.

In one embodiment, the outer diameter of the septum <NUM> is larger than the inner diameter of the lumen of the first portion 26A of the safety cap <NUM> before the septum <NUM> is installed in the lumen.

In one embodiment, the septum <NUM> is disposed in the proximal end of the lumen of the first portion 26A, so as to form a closed cavity together with the septum <NUM> and the lumen <NUM>. Accordingly, the closed cavity prevents blood from leaking when the needle tip is isolated within the closed cavity of the safety cap <NUM>.

Referring back to <FIG> or <FIG>, in one embodiment, the insertion tool <NUM> comprises a guidewire advancement assembly <NUM> for distally advancing a guidewire <NUM> into the vasculature of the patient or proximally withdrawing the guidewire from the vasculature of the patient. In one embodiment, the guidewire advancement assembly <NUM> further includes a pusher <NUM> for operating movement of the guidewire <NUM> in preparation for the advancement of the catheter <NUM>.

<FIG> and <FIG> show the sectional view of the guidewire advancement assembly <NUM> before and after advancing the guidewire <NUM>. In one embodiment, at least a portion of the guidewire <NUM> is disposed within the lumen of the needle <NUM>. One end of the guidewire <NUM> is fixated to an anchor point <NUM> on the housing <NUM>, and the guidewire32 proximally extends from the anchor point <NUM>, enters a hole <NUM> of the pusher <NUM> via a first potion of the rail122A, extends away from the hole <NUM>, distally extends into a second portion of the rail122B, and finally extends into the lumen of the needle <NUM> through the needle base.

In one embodiment, the rail 122A-B includes a groove aligned with the hole <NUM> in the longitudinal direction of the catheter insertion tool. The groove serves to restrict the guidewire <NUM> and prevents unwanted waggle or bending of the guidewire <NUM> during operation. Specifically, as an embodiment, the anchor point <NUM> and the first portion of the rail 122A is disposed on an inner surface of the first portion 12A of the housing <NUM>. The anchor point <NUM>, the first portion of the rail 122A and the upper opening of the hole <NUM> of the pusher <NUM> are arranged in a line, which allows the guidewire <NUM> to straightly extend from the anchor point <NUM> to the hole <NUM>. The second portion of the rail 122B is disposed on an inner surface of the second portion 12B of the housing <NUM>. The bottom opening of the hole <NUM>, the second portion of the rail 122B and the proximal end of the needle <NUM> are arranged in a line, which allows the guidewire <NUM> to straightly extend from the hole <NUM> into the lumen of the needle <NUM>. In another embodiment, at least a part of the rail 122A-B is a pipe.

<FIG> shows the configuration of the guidewire advancement assembly <NUM> before operation, where the pusher <NUM> is positioned close to the proximal end of the housing. When the pusher <NUM> is distally moved to a position close to the needle base as shown in <FIG>, the guidewire <NUM> is distally advanced over a distance two times the moving distance of the pusher <NUM>.

<FIG> shows the structure of pusher <NUM>. <FIG> is a perspective view of one embodiment of the pusher <NUM>, where the pusher <NUM> includes a pushing block <NUM> and a slider <NUM>. In one embodiment, the pushing block <NUM> includes a hole <NUM> extending through the pushing block <NUM> from a top surface to a bottom surface of the pushing block <NUM>.

<FIG> is a sectional view of the pushing block <NUM>, and <FIG> is a perspective view of the pushing block <NUM>. As shown in <FIG> and <FIG>, the pushing block <NUM> includes four sidewalls defining the hole <NUM>. In one embodiment, the four sidewalls of the hole <NUM> includes a first sidewall 134A in the form of a planar curve, and a straight second sidewall 134B opposite to the first sidewall. The minimum distance between the first and second sidewalls 134A and 134B is wide enough to allow free longitudinal movement of a guidewire <NUM> and is narrow enough to restrict sway of the guidewire <NUM>. In another embodiment, the second sidewall 134B is also in the form of a planar curve, wherein the planar surface of the second sidewall 134B is in parallel to the planar surface of the first sidewall 134A. In one embodiment, the other two sidewalls are straight.

Referring back to <FIG> and <FIG>, in one embodiment, the slider <NUM> is connected to the pushing block <NUM>, the pushing block <NUM> is disposed inside the housing <NUM> and the slider <NUM> is partially disposed outside the housing <NUM>. In one embodiment, a slit is formed between the second portion 13B of the housing and the proximal portion of the first portion 13A of the housing, which clamps the connection part between the pushing block <NUM> and the slider <NUM>, and allows the pusher <NUM> slide with respect to the housing <NUM>.

<FIG> and <FIG> show another embodiment of a guidewire advancement assembly <NUM> not encompassed by the wording of the claims but considered useful for understanding the invention. In one embodiment, the guidewire advancement assembly <NUM> includes a wheel <NUM> and a gear <NUM>, wherein the gear <NUM> is fixated to the wheel <NUM> coaxially. The rotation of the gear <NUM> synchronously drives the rotation of the wheel <NUM>. In one embodiment, a guidewire <NUM> is partially rolled around the outer diameter of the wheel <NUM>.

In one embodiment, the guidewire advancement assembly <NUM> further includes a rack <NUM>, which engage with the gear <NUM> through the engagement between the teeth of the rack146 and the teeth of the gear <NUM>. In one embodiment, a distal end of the rack <NUM> is slidably attached to a rail disposed on the housing. The sliding movement of the rack <NUM> along the rail drives the rotation of the gear <NUM> and the rotation of the wheel <NUM>, and the guidewire <NUM> is accordingly driven around the wheel <NUM>.

In one embodiment, the guidewire advancement assembly <NUM> further includes at least one idler <NUM> for restricting the guidewire <NUM> against the peripheral surface of the wheel <NUM>. In one embodiment, at least the peripheral surface of the wheel <NUM> is configured to provide sufficient friction for preventing skid between the wheel <NUM> and the guidewire <NUM>. This can be done by way of special treatment of the peripheral surface or by selecting a proper material to form the surface.

In one embodiment, the guidewire advancement assembly <NUM> further includes a pipe rail for guiding the movement of the guidewire <NUM>.

The advancement efficiency of the guidewire advancement assembly <NUM> depends on the ratio between the diameter of the gear <NUM> and the wheel <NUM>. For example, if the ratio between the diameter of the gear <NUM> and the wheel <NUM> is <NUM>:<NUM>, the ratio between the sliding distance of the rack <NUM> and the moving distance of the guidewire is also <NUM>:<NUM>.

<FIG> depict various stage of the operation of the insertion tool <NUM> to place the catheter <NUM> into 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 on <FIG>, a user grasping the insertion tool <NUM> first guides the distal portion needle <NUM> through the patient's 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 <NUM> due to blood passing out of the notch from the hollow interior of the needle. Note that in one embodiment, the presence of blood in the safety cap <NUM> serves 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 user operates the guidewire advancement assembly <NUM> or <NUM>. In one embodiment, as to the guidewire advancement assembly <NUM> shown in <FIG>, the pusher <NUM> is distally slid by the finger of the user to distally advance the guidewire <NUM>, which is initially disposed within the hollow needle <NUM>. In another embodiment, as to the guidewire advancement assembly <NUM> shown in <FIG>, the rack <NUM> is distally slid by the finger of the user to distally advance the guidewire <NUM>. The distal advancement of the guidewire continues until the pusher <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>. In one embodiment, further distal advancement of the pusher <NUM> is prevented when the pushing block <NUM> contacts the needle base.

Once the guidewire <NUM> has been fully extended within the vessel of the patient, the user operates the catheter advancement assembly <NUM>, wherein the catheter hub <NUM> is distally advanced by the user to cause the catheter <NUM> to slide distally over the needle <NUM> and the guidewire <NUM> and into the patient's vasculature via the insertion site. At this stage, further distal movement of the catheter hub and the catheter is prevented by the distal portion of the housing. The user then may slide the distal part of the first portion of the housing with respect to the second portion of the housing to release the engagement between the two housing portions. After the release, further distal movement of the catheter hub and the catheter is allowed. To be noted, during the distal sliding of the catheter hub <NUM>, since the safety cap <NUM> is initially engaged with the catheter hub <NUM>, the safety cap <NUM> also slides with the catheter hub <NUM>.

After the catheter <NUM>, catheter hub <NUM> and safety cap <NUM> are released from the housing, the user may further advance the catheter hub <NUM> distally and withdraw the needle <NUM> from the body of the patient. These two movements can be operated simultaneously or successively. Distal movement of the catheter hub and the safety cap relative to the needle or the housing is stopped when the safety cap is locked to the locking point and the needle tip is isolated within the safety cap.

With the needle tip withdrawn from the fingers of the safety cap and stopped inside the lumen of the first portion of the safety cap, the catheter hub <NUM> is free to be separated from the safety cap by the user. As mentioned, the septa in the catheter cap and the safety cap prevents exposure of blood of the patient. Then the catheter <NUM> remain in the body of the patient, the catheter hub <NUM> remains close to the insertion site, and the housing <NUM>, needle <NUM>, safety cap <NUM> and guidewire advancement assembly can be removed.

In one embodiment the insertion tool <NUM> of the present invention can include a cap or other protective device that is removably attached to the insertion tool before use so as to protect the needle and catheter.

Claim 1:
A catheter insertion tool, comprising:
a housing (<NUM>) in which at least a portion of a catheter (<NUM>) is initially disposed;
a needle (<NUM>) distally extending from the housing (<NUM>); and
a safety cap (<NUM>) slidable along the needle (<NUM>), wherein the safety cap (<NUM>) is configured to be locked to the housing (<NUM>) when distally sliding to a position of isolating the tip of the needle (<NUM>) within the safety cap (<NUM>), and
a catheter hub (<NUM>) which is connected to the safety cap (<NUM>) until the safety cap (<NUM>) is locked to the housing (<NUM>) when distally sliding to the position of isolating the tip of the needle (<NUM>), wherein a proximal end of the catheter (<NUM>) is connected to the catheter hub (<NUM>), wherein the safety cap (<NUM>) includes a first portion (26A) wrapping the needle (<NUM>) and a second portion (26B) slidably attached to a rail (<NUM>), the rail (<NUM>) being an integral part of or fixated to the housing (<NUM>).