Patent Description:
Catheters are used in a variety of medical procedures, including various drainage procedures such as drainage of the bladder, kidney or biliary system, abscesses, other sites of fluid collection. Typical drainage catheters have an externally-communicating filament lumen in their hub with a seal element (e.g. made of silicone) positioned in the filament lumen that seals around the filament to inhibit leakage of fluids through the filament lumen. Such catheters can also have features for gripping a length of the filament in order to secure the distal end of the catheter in an anchoring profile such as a coiled or "pigtail" profile.

There remain needs for catheters and methods for their preparation and use that effectively seal around a filament, manage proximal portions of the filament, and are robust in use, providing opportunities for multiple modes of operation in and around the catheter hub. Aspects of the present disclosure are addressed to these needs. <CIT> describes drainage catheter hub devices which seal the hub from leakage when connected to a catheter. The catheter hub devices include a hub body having an aperture with a sealing element mounted therein and a fluid passageway that communicates with the aperture. The fluid passageway and sealing element are configured to receive a tension member. A lever arm attached to the hub body is operable to secure the position of the tension member in the sealing element in a locked position or allow movement of the tension member through the sealing element in an unlocked position. The lever arm is configured to engage and compresses the sealing element to block fluid flow through the sealing element and the aperture when the lever arm is in any position. The hub body may include a centering tab to align the tension member along a longitudinal axis of the hub body. <CIT> describes a catheter hub for use with a medical device and a catheter, the hub includes a hub body defining a fluid passageway in communication with a first aperture.

In one aspect, the present disclosure provides a catheter including a catheter tube defining a catheter lumen, the catheter tube having a distal region. A hub is attached to the catheter tube and includes a hub body and a locking arm connected to the hub body. The locking arm has an outer surface defining a cutting notch that can have a cutting notch bottom wall. The catheter also includes a filament for securing the distal region of the catheter tube in an anchoring profile, the filament extending from the distal region of the catheter tube to the hub. The filament includes a proximal filament segment external of the hub body, and the proximal filament segment is positionable to a filament path providing a first filament portion extending over the cutting notch bottom wall of the locking arm outer surface and a second filament portion extending between the locking arm and the hub body. The locking arm is movable relative to the hub body between an unlocked position in which the second filament portion is not positionally fixed by compression between the locking arm and the hub body, and a locked position in which the second filament portion is positionally fixed by compression between the locking arm and the hub body for securing the distal region of the catheter tube in the anchoring profile. In some forms, the hub body defines a hub lumen in fluid communication with the catheter lumen and a seal seat passage fluidly communicating with the hub lumen and having a seal seat passage opening at a location on an outer surface of the hub body, and a sealing element is at least partially positioned in the seal seat passage. The filament can pass from the catheter lumen into the hub lumen, through the seal seat passage and sealing element, and out of the seal seat passage opening. The locking arm can have an inner surface facing the outer surface of the hub body, with the inner surface of the locking arm having a filament fixing region cooperable with a filament fixing region of the outer surface of the hub body to compress and thereby positionally fix the second filament portion when the locking arm is in the locked position. The filament fixing region of the outer surface of the hub body can include a protrusion or protrusions for cooperating with a recess or recesses of the filament fixing region of the inner surface of the locking arm, and/or the filament fixing region of the inner surface of the locking arm can include a protrusion or protrusions for cooperating with a recess or recesses of the filament fixing region of the outer surface of the hub body.

In another aspect, the present disclosure provides a method for securing and releasing a distal anchor of a catheter, the catheter including a hub, a catheter tube attached to the hub and having a distal region securable in an anchoring profile, and a filament extending from the distal region of the catheter tube to the hub, the filament having a first portion and a second portion. The method includes moving a locking arm of the hub to a locked position to compress the second portion of the filament between the locking arm and a hub body of the hub and thereby provide a secured condition of the distal region in the anchoring profile. The method also includes inserting a cutting edge into a cutting notch defined in an outer surface of the locking arm so as to cut the first portion of the filament positioned in the cutting notch, so as to release the secured condition of the distal region in the anchoring profile. The secured condition of the distal region in the anchoring profile can be held by a tensioned length of the filament, and the first portion can occur within the tensioned length of the filament. The cutting notch can have a bottom surface that is recessed relative to surfaces of the locking arm adjacent to the cutting notch.

In another aspect, the present disclosure provides a catheter including a catheter tube defining a catheter lumen, the catheter tube having a distal region. A hub is attached to the catheter tube, with the hub including a hub body and a locking arm connected to the hub body. The locking arm is movable relative to the hub body between an unlocked position for allowing travel of a filament portion between the locking arm and the hub body and a locked position in which the filament portion is positionally fixed by compression between a filament fixing region of the locking arm and a filament fixing region of the hub body for securing the distal region of the catheter tube in an anchoring profile. When the locking arm is in the locked position in a relaxed condition, at least a portion of the fixing region of the locking arm is spaced a distance from the fixing region of the hub body. Also included is a filament for securing the distal region of the catheter tube in an anchoring profile, the filament extending from the distal region of the catheter tube to the hub. The filament includes a proximal filament segment external of the hub body, wherein the proximal filament segment includes the filament portion, wherein the filament portion has a diameter, and wherein the ratio of said diameter to said distance is in the range of about <NUM>:<NUM> to about <NUM>:<NUM>. The filament fixing region of the outer surface of the hub body can include a protrusion or protrusions for cooperating with a recess or recesses of the filament fixing region of the inner surface of the locking arm, and/or the filament fixing region of the inner surface of the locking arm can include a protrusion or protrusions for cooperating with a recess or recesses of the filament fixing region of the outer surface of the hub body. The locking arm can define a first opening and a second opening, and the proximal filament segment can extend in a filament path that exits the hub body and passes through the first opening to the outer surface of the locking arm, and through the second opening and into a compression zone between the fixing region of the inner surface of the locking arm and the fixing region of the outer surface of the hub body. The locking arm can also define a third opening, and the filament path can exit the compression zone and pass through the third opening to the outer surface of the locking arm. The locking arm can define a cinching notch proximal of the third opening, with the cinching notch configured to grip and secure the filament when forced into the notch.

In still another aspect, the present disclosure provides a method for securing a distal region of a catheter in an anchoring profile, the catheter including a hub, a catheter tube attached to the hub and having a distal region securable in the anchoring profile, and a filament extending from the distal region of the catheter tube to the hub. The method includes providing a portion of the filament positioned between a fixing surface of the locking arm and a fixing surface of the hub body, the portion of the filament having a diameter. The method further includes moving the locking arm to a locked position to compress the portion of the filament between the fixing surface of locking arm and the fixing surface of the hub body and thereby provide a secured condition of the distal region in the anchoring profile. In the method, the locking arm and hub body are configured such that when the locking arm is in the locked position in a relaxed condition, at least a portion of the fixing surface of the locking arm is spaced a distance from the fixing surface of the hub body, wherein the ratio of said diameter to said distance is in the range of about <NUM>:<NUM> to about <NUM>:<NUM>.

Additional aspects of the present disclosure, including but not limited to methods of assembling catheters as disclosed herein, as well as features and advantages thereof, will be apparent to those skilled in the pertinent field from the disclosures herein.

While the present disclosure may be embodied in many different forms, for the purpose of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the claims is thereby intended. Any alterations and further modifications in the described embodiments and any further applications of the principles of the present disclosure as described herein are contemplated as would normally occur to one skilled in the art to which the disclosure relates.

As disclosed above, in certain aspects, the present disclosure provides catheter devices and methods of their preparation and use. The catheters can have a distal catheter tube region that can be secured in an anchoring profile by a locking engagement of a filament at a catheter hub. The catheter hub can include a locking arm that cooperates with a hub body to provide a locked position that compresses and positionally fixes a first portion of the filament between a fixing surface of the locking arm and a fixing surface of the hub body. The locking arm can define a cutting notch in its outer surface through which a second portion of the filament passes in the locked position, and the second portion of the filament can be cut to release the secured condition of the anchoring profile as the locked position of the hub is maintained. The locked position defined between the hub body and the locking arm can leave at least a portion of the respective fixing surfaces of the locking arm and the hub body spaced from one another a distance, when in a relaxed or unstressed condition. The locking arm can include first, second and third holes for routing the filament between the inner and outer surfaces of the locking arm, which can provide a filament path extending through the cutting notch and between the fixing surfaces of the locking arm and hub body. The locking arm can define a cinching notch for cinching (gripping by friction) and thereby securing a proximal-most segment of the filament when a segment of the filament is forced into the notch. At least a portion of the cinching notch can have a width that is less than the diameter of the forced segment of the filament for these purposes. These and other features of a catheter can be provided singly or in various combinations, including combinations with features provided in the Detailed Description below.

In discussions herein, the terms "proximal" and "distal" will be used to describe the opposing axial ends of the catheter, as well as the opposing axial ends of component features, such as the drainage catheter hub. The term "proximal" is used in its conventional sense to refer to the end of the catheter, or component feature, that is closest to the operator during use. The term "distal" is used in its conventional sense to refer to the end of the catheter, or component feature, that is furthest from the operator during use.

With reference now to <FIG>, there is shown a drainage catheter <NUM> and components thereof according to one embodiment of the present disclosure. In this illustrative arrangement, the catheter <NUM> has a hub <NUM> that includes a hub body <NUM> and a locking arm <NUM> attached and movable with respect to the hub body <NUM>. The locking arm <NUM> is movable to a locked position to compress a filament <NUM> between the locking arm <NUM> and hub body <NUM> to fix the position of the compressed portion of the filament <NUM>. The hub body has a distal end <NUM> that is configured to engage with a catheter tube <NUM> at a proximal end <NUM> of the tube <NUM>. The hub body <NUM> also includes a connector end <NUM> (e.g. a tapered or threaded luer lock end) that is configured for attachment to a drainage collection system (not shown). The hub body <NUM> defines a hub lumen <NUM> that fluidly communicates with a catheter lumen <NUM> of the catheter tube <NUM>. The hub body also defines a seal seat passage <NUM> that fluidly communicates with the hub lumen <NUM>, with the passage <NUM> having a first passage opening <NUM> (see <FIG> and <FIG>) at the hub lumen <NUM> and a second passage opening <NUM> (<FIG>) at a location on the external surface of the hub body <NUM>. A sealing element <NUM> is received in the seal seat passage <NUM>. In its relaxed state, sealing element <NUM> defines a seal element lumen <NUM> extending through the seal element <NUM>, through which the filament <NUM> passes. As received in the seal seat passage <NUM>, the sealing element <NUM> is radially compressed to close the seal element lumen <NUM> around the portion of the filament <NUM> passing through the seal element <NUM>. In some embodiments, an inner surface portion <NUM> of the locking arm <NUM> is configured to contact, and optionally press against and compress, an upper surface <NUM> of the sealing element <NUM> when the locking arm <NUM> is in a locked position relative to the hub body <NUM>. A configuration where the inner surface portion <NUM> presses against upper surface <NUM> can cause compression of the sealing element <NUM> to enhance the seal of the sealing element <NUM> against the filament <NUM>.

The particular illustrated hub body <NUM> extends along a longitudinal axis in a substantially cylindrical fashion between its distal end <NUM> and its proximal end <NUM>. The hub lumen <NUM> extends longitudinally between the distal end <NUM> and the proximal end <NUM>. The hub lumen <NUM> is configured to receive a portion of the filament <NUM> and enable liquids and/or gases to pass therethrough.

The hub body <NUM> includes a lower body portion <NUM> opposite an upper body portion <NUM> and a right face <NUM> opposite a left face <NUM> wherein the lower and upper portions <NUM> and <NUM> and the right and left faces <NUM> and <NUM> occur between the distal and the proximal ends <NUM> and <NUM>. Generally, the lower body portion <NUM> has a substantially smooth outer surface. Each of the right and left faces <NUM> and <NUM>, respectively, includes a post <NUM> positioned closer to the distal end <NUM> of the hub body <NUM>. In one form, the posts <NUM> have a cylindrical shape and extend a distance outward from the right and left faces <NUM> and <NUM>, respectively. The posts <NUM> are sized and configured to engage and retain the locking arm <NUM> such that the locking arm <NUM> is able to rotate about the posts <NUM> to provide a pivotal connection of the locking arm <NUM> to the hub body <NUM>. It will be understood that other movable connections are also contemplated as within the scope of this disclosure. Each of the right and left faces <NUM> and <NUM> also includes a transition recess <NUM> spaced a distance from a locking recess <NUM>, wherein the transition recess <NUM> and the locking recess <NUM> are positioned closer to the proximal end <NUM> than the distal end <NUM>. The transition and locking recesses <NUM> and <NUM> are sized and configured to cooperate with an interior nub <NUM> on each side of the locking arm <NUM>, where when moving the locking arm <NUM> toward its locked position the nubs <NUM> enter transition recesses <NUM> and a user receives a tactile indication of cooperation between the locking arm <NUM> and the hub body <NUM>, in the form of resistance to further travel. That resistance can be overcome with force applied to the locking arm <NUM> to outwardly flex the locking arm side portions <NUM> and <NUM> defining the nubs <NUM>, whereupon the nubs <NUM> travel further toward locking recesses <NUM> and then enter locking recesses <NUM> with inward flexure of the locking arm side portions <NUM> and <NUM>, to establish the locking arm <NUM> in its locked position relative to the hub body <NUM>. The transition recesses <NUM> each provide a ramp surface 58A that slopes outwardly in a direction extending toward the lower body portion <NUM>, which can facilitate the engagement and downward slide of the nubs <NUM> onto the right and left faces <NUM> and <NUM>, respectively, prior to the entry of the nubs <NUM> into the locking recesses <NUM> to provide the locked position of the hub <NUM>. In some embodiments, such a locked position spaces at least a portion of filament fixing surface regions from one another, as discussed herein.

The upper body portion <NUM> of the hub <NUM> defines the seal seat passage <NUM> that spans from the hub lumen <NUM> to the external surface of the hub body <NUM>. The passage <NUM> is sized to receive and retain the sealing element <NUM>. The passage <NUM> can be generally cylindrical in shape, although other shapes are also contemplated as suitable for use herein. In some forms, the passage <NUM> has an inner diameter that is smaller than the outer diameter of the sealing element <NUM>, so that insertion of the sealing element <NUM> into the passage <NUM> causes inward radial compression of the sealing element <NUM>. This can in turn deform the sealing element <NUM> to enhance the seal between the sealing element <NUM> and the portion of the filament <NUM> passing therethrough.

The upper body portion <NUM> defines an outer surface that includes a filament fixing region <NUM> and the locking arm defines an inner surface that includes a filament fixing region <NUM>. Surface regions <NUM> and <NUM> cooperate to form a compression zone for compressing a portion of the filament <NUM>. When the locking arm <NUM> is in a locked position relative to the hub body <NUM>, the fixing region <NUM> and the fixing region <NUM> compress and thereby positionally fix the portion of the filament <NUM> positioned between the fixing regions <NUM> and <NUM>. In beneficial forms, the filament fixing region <NUM> includes at least one protrusion for cooperating with a recess of the filament fixing region <NUM>, and/or the filament fixing region <NUM> includes at least one protrusion for cooperating with a recess of the filament fixing region <NUM>. In certain forms, the filament fixing region <NUM> includes a plurality of protrusions for cooperating with a plurality of recesses of the filament fixing region <NUM>, and/or the filament fixing region <NUM> includes a plurality of protrusions for cooperating with a plurality of recesses of the filament fixing region <NUM>. The protrusion(s) can have any suitable contour, for example having a polygonal shape (e.g. a triangular or rectangular shape) or a curved shape presenting a smoothly rounded convex surface contour, and in beneficial forms are elongate in a direction transverse to the longitudinal axis of the hub body <NUM> and locking arm <NUM> (e.g. in the form of elongate rib protrusion(s)). The recess(es) for cooperating with the protrusion(s) can present a concave surface contour that may correspond to the contour of the protrusion(s), for example a triangular recess(es) for cooperating with a triangular protrusion(s), a rectangular recess(es) for cooperating with a rectangular protrusion(s), or a curved recess(es) for cooperating with a curved protrusion(s). In other embodiments, the recess(es) can present a concave surface contour that does not correspond to the contour of the protrusion(s) with which it or they cooperate. The recess(es) in beneficial forms are also elongate in a direction transverse to the longitudinal axis of the hub body <NUM> and locking arm <NUM>, for example in the form of elongate troughs. In the illustrated embodiment, provided on the hub body <NUM> are a plurality of curved protrusions 68A, each defining an elongate, smoothly-curved apex surface contour, and provided on the locking arm <NUM> are a plurality of recesses 70B each defining a concave contour that does not correspond to the contour of their respective opposed protrusions 68A, and thus does not extend in parallel to the surface contour of the opposed protrusions 68A in the locked position. As well, provided on the locking arm <NUM> are a plurality of curved protrusions 70B, each defining an elongate, smoothly-curved apex surface contour, and provided on the hub body <NUM> are a plurality of recesses 68B, each defining a concave contour that does not correspond to the contour of their respective opposed protrusions 70B, and thus does not extend in parallel to the surface contour of the opposed protrusions 70B in the locked position. It will be understood that in other embodiments, recess(es) on the hub body <NUM> and/or locking arm <NUM> can define a surface contour that extends in parallel to the surface contour of their opposed protrusion(s) in the locked position of the locking arm <NUM>.

The locking arm <NUM> is movable relative to the hub body <NUM> between an unlocked position (see e.g. <FIG>) and a locked position (see e.g. <FIG> and <FIG>). In the unlocked position, a portion of filament <NUM> located between fixing region <NUM> and fixing region <NUM> is not positionally fixed and can slide longitudinally. In the locked position, a portion of filament <NUM> located between fixing region <NUM> and fixing region <NUM> is compressed between regions <NUM> and <NUM> and thereby positionally fixed so as to secure a distal region of the catheter tube in an anchoring profile, for example a profile as discussed further below. In certain embodiments, when the locking arm <NUM> is in the locked position relative to the hub body <NUM> and in a relaxed (unstressed) condition, at least a portion of, or at least a plurality of portions of, the fixing region <NUM> of the locking arm <NUM> is/are spaced a distance "D" (see <FIG>) from the fixing region <NUM> of the hub body <NUM>. In preferred forms, a portion of the filament <NUM> to be received and compressed between fixing surfaces <NUM> and <NUM> has an outer diameter, and the distance D is selected to define a ratio relative to such outer diameter of at about <NUM>:<NUM> or greater, for example in the range of about <NUM>:<NUM> to about <NUM>:<NUM>, or in the range of about <NUM>:<NUM> to about <NUM>:<NUM>. With a defined spacing between fixing regions <NUM> and <NUM> in the locked position, it has been discovered that a more facile and reliable movement of the locking arm <NUM> to its locked condition relative to hub body <NUM> can be facilitated, e.g. as compared to a configuration in which the fixing regions <NUM> and <NUM> are configured to continuously contact one another when the locking arm <NUM> is in the locked position relative to the hub body <NUM> in a relaxed condition (without a filament received between the arm <NUM> and body <NUM>). In advantageous forms, a substantial percentage (i.e. greater than about <NUM>%) of the surface area of the fixing region <NUM> is spaced the distance D from the fixing region <NUM> with the locking arm <NUM> in the locked position in a relaxed condition, more preferably greater than about <NUM>%, and in some forms in the range of about <NUM>% to about <NUM>%.

The locking arm <NUM> includes features for defining a filament management path in association with the hub <NUM>. In the illustrated embodiment, the locking arm <NUM> defines a first opening <NUM> that is sized to receive the filament <NUM> therethrough in a direction from the inner surface of the locking arm <NUM> to the external surface of the locking arm <NUM>. The first opening <NUM> is desirably positionable to longitudinally coincide at least in part with and in some forms entirely with the seal seat passage opening <NUM>, for example when the locking arm <NUM> is in the locked position, and/or is desirably elongate in the longitudinal direction of the hub <NUM>. The locking arm also defines a second opening <NUM> spaced proximally from the first opening <NUM> and sized to receive the filament <NUM> therethrough in a direction from the outer surface to the inner surface of the locking arm <NUM>. The locking arm <NUM> also defines a third opening <NUM> at a position spaced proximally from the second opening and sized to receive the filament <NUM> therethrough in a direction from the inner surface to the outer surface of the locking arm <NUM>. The second opening <NUM> and the third opening <NUM> occur to either side of the fixing region <NUM> of the locking arm <NUM>. In this manner, a proximal segment of the filament that is external of the hub body <NUM> can be positioned in a filament path that passes through the first opening <NUM> to the external surface of the locking arm <NUM>, over the external surface of the locking arm to the second opening <NUM>, through the second opening <NUM> to the internal surface of the locking arm, across the fixing surface <NUM> of the locking arm <NUM>, to the third opening <NUM>, and through the third opening <NUM> to the external surface of the locking arm <NUM> (see <FIG>). A proximal-most length of the filament <NUM> can then be exposed out of the third opening <NUM>. In certain forms, the locking arm <NUM> further defines a cinching notch <NUM>, desirably at or proximate to the proximal end <NUM> of the locking arm <NUM>. The proximal-most length of the filament <NUM> can be cinched and secured in the cinching notch <NUM> and, if desired, an end portion of the filament <NUM> extending proximally beyond the notch <NUM> can be trimmed off.

All or some of the transitions between surfaces in the filament management path, including surfaces on the hub body <NUM> and on the locking arm <NUM>, can be filleted. In this manner, smooth or smoother travel of the filament longitudinally through the filament path can be provided. Thus, the transition between the surface of the hub lumen <NUM> and the inner wall of seal seat passage can be filleted; and/or the transition between the wall of the opening <NUM> and the bottom wall <NUM> of the notch <NUM> can be filleted; and/or the transition between the bottom wall <NUM> of the cutting notch <NUM> and the wall of the opening <NUM> can be filleted; and/or the transition between the wall of the opening <NUM> and the filament fixing surface region <NUM> can be filleted; and/or the transition between the filament fixing surface region <NUM> and the wall of the opening <NUM> can be filleted; and/or the transition between the wall of the opening <NUM> and the adjacent outer surface of the locking arm <NUM> can be filleted. In some embodiments, each of these surface transitions can be filleted. A filleted transition between two surfaces provides a smooth rounded corner between the two surfaces, which in some forms may be a constant-radius rounded surface.

In the illustrated embodiment, the locking arm <NUM> defines an elongate cutting notch <NUM> positioned between the first opening <NUM> and the second opening <NUM>. The cutting notch <NUM> can be elongate in a direction transverse (e.g. perpendicular) to the path of filament <NUM> between the first and second openings <NUM> and <NUM>, which can also be transverse (e.g. perpendicular) to the longitudinal axis of the hub <NUM>. Cutting notch <NUM> has a bottom surface <NUM> defined by the locking arm <NUM> and occurring as a portion of the external surface of the locking arm <NUM>. In use, the portion of filament <NUM> passing through cutting notch <NUM> can be severed, for example by inserting a sharp edge of an instrument (e.g. a scalpel) into the cutting notch <NUM>, to release the secured condition of the distal region <NUM> of the catheter tube <NUM> in the anchoring profile. This can be done while the locking arm <NUM> is in its locked position relative to the hub body <NUM>. In advantageous forms, as in the illustrated form, the bottom surface <NUM> of the cutting notch <NUM> is recessed relative to the outer surfaces of the locking arm adjacent to the cutting notch <NUM>, so that a portion of the filament <NUM> passing over and against bottom surface <NUM> is also recessed relative to such adjacent outer surfaces. In this manner, the portion of the filament passing through cutting notch <NUM> can be relatively protected against undesired contact, for instance snagging or rubbing, during use of catheter <NUM> with the locking arm <NUM> in the locked position (e.g. during the catheter <NUM> insertion procedure or during an indwelling period of catheter <NUM>).

As to other features, the locking arm <NUM> can also include at least one, or a plurality of, top rib(s) <NUM> defined on its exterior surface. The locking arm <NUM> can also include one or more elongated side ribs <NUM> on its exterior surface along a right side portion <NUM> and along a left side portion <NUM> of the locking arm <NUM>. The top rib(s) <NUM> and the side rib(s) <NUM> provide a tactile sensation to a user when they grip or handle the catheter hub <NUM>. The top and side rib(s) <NUM> and <NUM> can also provide a gripping surface for a user such that when a syringe is secured to the catheter hub <NUM>, the user has a gripping surface to hold onto to prevent the catheter hub <NUM> from rotating. The locking arm <NUM> can also include an undercut recess <NUM> at or proximate to the proximal end <NUM>. The tip of an implement such as a pair of forceps can be used to engage undercut recess <NUM> and pry upon locking arm <NUM> to forcibly release it from its locked position relative to hub body <NUM>, during which nubs <NUM> will be forced to exit locking recesses <NUM> and arm <NUM> will pivot away from hub body <NUM>.

The locking arm <NUM> in the illustrated embodiment it defines a concave interior shape configured to enclose and substantially cover the upper body portion <NUM>, the right face <NUM>, and the left face <NUM> of the hub body <NUM>. Each of the right side portion <NUM> and left side portion <NUM> of the locking arm <NUM> defines an opening <NUM> that is sized and positioned to receive the corresponding post <NUM> therein to attach the locking arm <NUM> to the hub body <NUM>. In assembling the locking arm <NUM> onto the hub body <NUM>, the right and left side portions <NUM> and <NUM> of the locking arm <NUM> can be flexed outwardly to position the openings <NUM> over the posts <NUM>, and then caused or allowed to flex back inwardly to position and retain the posts <NUM> within the openings <NUM>. Other cooperative connections of the locking arm <NUM> and hub body <NUM> are contemplated. For example, in one alternative, the hub body <NUM> may define a hole and the locking arm <NUM> may include a post receivable in the hole to connect the locking arm <NUM> to the hub body <NUM>. Other embodiments may include still other cooperative connections between the locking arm <NUM> and the hub body <NUM> that permit movement of the two relative to one another, and may include for example pivoting connections, hinged connections, sliding connections or other movable connections.

With the locking arm <NUM> connected to the hub body <NUM>, the locking arm <NUM> can rotate to the locked position as discussed above. Rotation in the opposite (opening) direction is also permitted, preferably to a stop point at which an interaction between a locking arm <NUM> surface and a hub body <NUM> surface prevents further rotation in the opening direction. In the illustrated embodiment, the hub body <NUM> defines a boss region <NUM> (see <FIG>) that contacts a distal stop region <NUM> of the outer surface of the locking arm <NUM> to prevent further rotation of the locking arm <NUM> in the opening direction. As illustrated, the boss region <NUM> can occur on a proximally-facing ridge defined by the hub body <NUM> that longitudinally overlaps a portion of the outer surface of the locking arm <NUM> and contacts the stop region <NUM> thereof at the stop point. In some forms, with the locked position of the locking arm <NUM> considered as <NUM> degrees, the locking arm can be rotated to a stop point in the range of about <NUM> degrees to about <NUM> degrees, or in some forms in the range of about <NUM> degrees to about <NUM> degrees.

As discussed above, in certain embodiments, when in the locked position relative to the hub body <NUM>, the locking arm <NUM> can contact, and in certain variants compress, the sealing element <NUM>. When the locking arm <NUM> compresses the sealing element <NUM>, this compression can enhance a seal around the filament <NUM> by the sealing element <NUM>, while still allowing longitudinal movement of the filament <NUM> through the sealing element <NUM> (when the locking arm is in an unlocked position). For these purposes, the interior surface of the locking arm <NUM> can include a seal-engagement portion <NUM>. In the illustrated embodiment, the engagement portion <NUM> is movable out of contact with the sealing element <NUM> by rotating the locking arm <NUM> in the opening direction. In certain forms, the engagement portion <NUM> can be circular in shape and can form a concave domed recess surface <NUM>, as illustrated. Other embodiments of the engagement portion <NUM> can have different shapes or contours as appropriate to contact and in some forms compress a particular sealing element design or position in or on the hub. When the surface of the seal engagement portion <NUM> compresses the sealing element <NUM>, it can cause the upper surface <NUM> of the sealing element <NUM> to conform to the shape of the surface of the seal-engagement portion <NUM>, for example with the upper surface <NUM> being compressed to a domed convex shape conforming to the concave domed recess surface <NUM> in the illustrated embodiment, see e.g. <FIG>.

The catheter tube <NUM> has a distal region <NUM> that is securable in an anchoring profile (<FIG>). The anchoring profile can include a curved configuration of the distal region <NUM>, including for example a coiled or "pigtail" configuration. In desirable forms, the distal region <NUM> is formed having shape memory that positions distal region <NUM> at least partially into its anchoring profile to be secured by tensioning filament <NUM>, which extends from distal region <NUM> to the hub <NUM> in the illustrated embodiment passing through the lumen <NUM> of the catheter tube <NUM>. As shown, the filament can include a first end region <NUM> secured to a distal location on the hub body <NUM>. In one form, the hub body <NUM> includes a loop structure <NUM> (<FIG>) on the external surface of a frusto-conical connection barb <NUM>, distal to a proximal end <NUM> of the connection barb <NUM> providing the largest diameter of the barb <NUM>. The loop structure <NUM> is desirably contained within the longitudinal profile defined by the proximal end <NUM> of the barb <NUM>, with the outermost surface of the loop structure <NUM> extending radially outward from the central axis of the hub body <NUM> a distance equal to, or preferably less than, the distance that the proximal end <NUM> of the barb <NUM> extends radially outward from the central axis of the hub body <NUM>. The first end region <NUM> of the filament <NUM> can extend through the opening of the loop structure <NUM> and be tied to the loop structure <NUM>. The filament <NUM> can extend in a path distally from the end region <NUM> through the lumen <NUM> to the distal region <NUM> to exit a first opening <NUM>. From first opening <NUM>, the filament <NUM> travels external of the catheter tube <NUM> to a second opening <NUM> at a location distal to the first opening <NUM> along the length of catheter tube <NUM>. Distal region can have additional openings <NUM> intermediate to the first and second openings <NUM> along the length of catheter tube <NUM>. Filament <NUM> enters the second opening <NUM> and travels proximally in the catheter lumen <NUM> and into the hub lumen <NUM>. Filament then extends through the seal seat passage <NUM> and the seal element <NUM>, exiting the hub body <NUM> to provide an externalized proximal filament segment to be managed in a path by the features of the hub body <NUM> and locking arm <NUM>, as discussed above.

The catheter <NUM> can also include a cap <NUM> (see <FIG> and cap shown in phantom in <FIG>) that covers a transition region between the hub body <NUM> and the catheter tube <NUM> and can provide strain relief between the body <NUM> and tube <NUM>. Cap <NUM> includes an end opening <NUM> through which catheter tube <NUM> is received, and a proximal connection region <NUM> for establishing a connection to the hub body <NUM>. In the illustrated embodiment, the connection region <NUM> includes circumferentially-extending slots 124A and interiorly-directed posts 124B. The slots 124A can receive corresponding projections 126A on a distal region of hub body <NUM>, and the posts 124B can be received in corresponding recesses 126B on the distal region of hub body <NUM>, whereafter the cap <NUM> and hub body <NUM> can be rotated relative to one another to lock the cap <NUM> to the hub body <NUM>.

<FIG> show hub body designs providing alternative features for securing the first end region <NUM> of the filament <NUM> to the hub body. Except for the following differences, the hub body 12A (<FIG>) and the hub body 12B (<FIG>) can have the same features as the hub body <NUM> discussed above. With reference to <FIG>, the frusto-conical barb 108A in hub body 12A does not have the loop structure <NUM>, but instead has a wall portion <NUM> that defines a thru-hole <NUM>. The first end region <NUM> of filament <NUM> can be passed into the distal opening <NUM> and then through the thru-hole <NUM>, and then tied to itself at that location. In this embodiment, like with hub body <NUM> discussed above, the first end region <NUM> of the filament <NUM> is attached to the hub body at a location distal of the largest-diameter proximal end of the barb 108A. This can provide an advantageous filament attachment in these specific illustrated embodiments or other embodiments within the present disclosure. With reference to <FIG>, the frusto-conical barb 108B in hub body 12B does not have the loop structure <NUM>, but instead the distal region of hub body for connecting the transition cap has a post that defines a post undercut region <NUM> around which the first end region <NUM> of the filament <NUM> can be tied to itself.

Illustrative methods of using the catheter <NUM> will now be described. Initially, the distal region <NUM> of the catheter tube <NUM> is percutaneously inserted into a body cavity, such as the bladder. This step can be performed by inserting the distal end of a thin-walled hollow needle through the abdominal wall and into the bladder in a well-known manner. A wire guide can then be inserted through the needle into the bladder, and the needle can be removed, leaving the wire guide in place. A dilator may be used alone or in conjunction with an introducer or access sheath over the wire guide to increase the size of the puncture site. In advantageous forms, the hub <NUM> defines a small enough outer profile so that it may be used with a <NUM> French sheath without deformation to the sheath.

During percutaneous insertion of the catheter tube <NUM> over the wire guide, the catheter tube <NUM> will typically be manipulated into a generally straight configuration, with the locking arm <NUM> in an open position (e.g. as shown in <FIG>). This generally straight configuration may be achieved by inserting a flexible stiffener (not shown), such as a stylet, through the hub lumen <NUM> and the catheter lumen <NUM>. Following insertion of the straightened distal region <NUM> of the catheter tube <NUM> into the bladder, the wire guide and flexible stiffener can be removed from the patient. Where the distal region <NUM> has shape memory to self-configure to or toward the anchoring profile, the removal of the flexible stiffener will allow the region <NUM> to do so. The distal region <NUM> of the catheter tube <NUM> can be left in place for providing fluid flow from the bladder through the openings <NUM>-<NUM> of the distal region <NUM>, through the catheter tube lumen <NUM>, through the hub lumen <NUM>, and to a conventional fluid collection system (not shown), such a system including for example a tubing fluidly coupled to the end <NUM> of the hub body <NUM> and a plastic collection bag.

To inhibit unintended withdrawal or dislodgement of the distal region <NUM> of the catheter tube <NUM> from the bladder or other body cavity, the locking features of the hub <NUM> are used to secure the distal region <NUM> in the anchoring profile, for example a loop as shown in <FIG>.

To secure the anchoring profile, an operator can grasp and apply tension to the proximal portion of the filament <NUM>, while the locking arm <NUM> is in an unlocked, or open position (<FIG>), and then the locking arm <NUM> can be moved to its locked position (<FIG> and <FIG>). In some forms, where the distal region <NUM> has shape memory to self-configure toward the desired anchoring profile, the application of tension to filament <NUM> with the locking arm <NUM> in an unlocked position will reconfigure the self-configured profile caused by the shape memory to the final desired anchoring profile. In other forms, the distal region <NUM> may lack shape memory to or toward the desired anchoring profile (e.g. be generally straight), and the application of tension to the filament <NUM> with the locking arm <NUM> in the unlocked position can configure the distal region <NUM> from a generally straight profile to the desired anchoring profile. Movement of the locking arm <NUM> to the locked position relative to the hub body while maintaining the applied tension to the filament <NUM> can then secure the distal region <NUM> in the desired anchoring profile. The proximal-most portion of the filament <NUM> can then be secured in the cinching notch <NUM> and, if desired, some or all of the remaining filament extending proximal of the notch <NUM> can be trimmed off. In other uses, the cinching notch <NUM> can be employed to cinch the filament <NUM> for temporary filament positioning adjustments (e.g. to adjust tension on the filament <NUM>) prior to locking the locking arm <NUM>.

When removal of the catheter <NUM> from the patient is desired, in one mode of use, an operator can insert a sharp edge of an implement into cutting notch <NUM> to thereby sever the filament <NUM> at that location. This separates a portion of the filament proximal thereof that remains compressed and positionally fixed between fixing regions <NUM> and <NUM> of the hub body and locking arm, respectively, from a portion of the filament that occurs distal of severed filament location that is now capable of longitudinal movement in a distal direction. In another mode of use, the locking arm <NUM> can be forced from the locked position to an unlocked position, to thereby eliminate the positionally-fixing compression of the filament <NUM> by the fixing regions <NUM> and <NUM> and allow longitudinal movement of the filament in the distal direction. For this operation, in the illustrated embodiment, the tip of an instrument, such as the tip of a pair of forceps, can be inserted into undercut recess <NUM> and used to pry the locking arm <NUM> from its locked position to an unlocked position. After severing the filament <NUM> in the cutting notch <NUM>, or after movement of the locking arm <NUM> to an unlocked position, the catheter <NUM> can be pulled from the patient during which the distal region <NUM> can return to a generally straight condition for travel through patient tissues. In cases where the distal region <NUM> has shape memory for configuring to or toward the anchoring profile, contact with patient tissues can overcome the shape memory and force the distal region <NUM> to a generally straight condition. Alternatively, it would be possible to insert a straightening implement such as a stylet into the catheter <NUM> to bring it to a generally straight condition, and the implement and catheter <NUM> removed together.

The components of a catheter system may be formed with any suitable material. These include for example synthetic polymeric materials. For example, the hub body <NUM> may be formed from a synthetic polymeric material, for example polybutylene terephthalate; the locking arm <NUM> may be formed from a suitable synthetic polymeric material, for example high density polyethylene; the catheter tube <NUM> may be formed from a suitable synthetic polymeric material, for example a polyurethane polymer; the filament <NUM> may be formed from a natural or synthetic polymeric material or a metallic material, and in preferred forms is a monofilament structure and especially a polyamide polymer (e.g. nylon) monofilament; the cap <NUM> may be formed from a suitable synthetic polymeric material, for example high density polyethylene; and, the sealing element <NUM> may be formed from an elastomeric material, for example a synthetic polymeric elastomeric material such as silicone. The components of hub assembly <NUM>, including the hub body <NUM>, the locking arm <NUM>, and the sealing element <NUM>, may be manufactured by injection molding. In one embodiment, the locking arm <NUM> is configured to flex more than the hub body <NUM>, and for these purposes can be made from a synthetic polymeric material that has a lower tensile modulus than that of which the hub body <NUM> is made. The filament <NUM> may be manufactured by extrusion, especially when formed from a synthetic polymeric material.

It is to be appreciated in the context of the present disclosure that, to the extent that certain methods disclosed herein may be applied to the living human or animal body, it will be appreciated that such methods may also be applied in circumstances which do not provide any surgical or therapeutic effect. For example, such methods may be applied without any reference to tissue and/or ex vivo, to tissue samples that are not part of the living human or animal body. For example, the methods described herein may be practiced on meat, tissue samples, cadavers, and other non-living objects.

The uses of the terms "a" and "an" and "the" and similar references herein (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., "such as") provided herein, is intended merely to better illuminate embodiments of the disclosure and does not pose a limitation on the scope of the disclosure unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the products or methods defined by the claims.

Claim 1:
A catheter, comprising:
a catheter tube (<NUM>) defining a catheter lumen, the catheter tube having a distal region (<NUM>);
a hub (<NUM>) attached to the catheter tube, the hub including a hub body (<NUM>) and a locking arm (<NUM>) connected to the hub body, the locking arm having an outer surface defining a cutting notch (<NUM>) having a cutting notch bottom wall comprising a portion of an external surface of the locking arm;
a filament (<NUM>) for securing the distal region of the catheter tube in an anchoring profile, the filament extending from the distal region of the catheter tube to the hub, the filament including a proximal filament segment external of the hub body, wherein the proximal filament segment is positionable to a filament path providing a first filament portion extending over the cutting notch bottom wall of the locking arm outer surface and a second filament portion extending between the locking arm and the hub body; and
the locking arm movable relative to the hub body between an unlocked position in which the second filament portion is not positionally fixed by compression between the locking arm and the hub body and a locked position in which the second filament portion is positionally fixed by compression between the locking arm and the hub body for securing the distal region of the catheter tube in the anchoring profile.