Patent Description:
This document pertains generally, but not by way of limitation, to a scoring device configured to receive a catheter.

In an approach, a catheter is coupled with a scoring device. The scoring device is bonded to a balloon of the catheter, and the scoring device is provided as a unitary assembly. Accordingly, in some approaches the catheter shaft is coupled (e.g., attached, glued, fused, or the like) with the catheter socket. Thus, each of the balloon, catheter, and cage have a specified size, or the like according to the particulars of the health care provider or application for the scoring device.

<CIT> and <CIT> each disclose cutting/scoring devices in the form of sleeves arranged to receive a main elongated medical instrument element such as a catheter.

The invention is a scoring device as defined in the appended claims.

The present inventors have recognized, among other things, that a problem to be solved can include attaching catheters of varying profiles to a scoring device.

In some approaches, the scoring device is coupled to a corresponding cage. For instance, in an approach a balloon catheter having a specified length and balloon profile is coupled with a cage having a specified profile. Accordingly, the balloon catheter is not separable from the cage. However, variations in length of the catheter (and characteristics of the balloon) are optionally needed based on different medical procedures, vascular locations, patient-specific anatomical variations, or the like.

The present subject matter can help provide a solution to this problem, such as by a scoring device that is interchangeable with a plurality of catheters, each of the plurality of catheters optionally having a different profile. For instance, A single or limited number of the scoring devices is maintained on hand by a healthcare provider. The present subject matter allows a healthcare provider to retain a variety of catheters (with varying profiles) on hand for a variety of procedures, vessel locations or the like. Where scoring is specified to assist with treatment of vasculature, one or a limited number of scoring devices are ready for marriage with the plurality of catheters as needed. Thus, the present subject matter minimizes the number of unique catheters needed while at the same time providing enhanced flexibility of selection and marriage, for example by allowing the physician to select catheters as specified (e.g., from any number of brands, sizes or the like) and then marrying the selected catheter to the scoring device described herein.

In an example, the scoring device is configured to retain a catheter shaft. In an example, the scoring device includes a proximal portion and a distal portion. The distal portion includes a distal tip. The scoring device includes a retention sleeve extending between the proximal portion and the distal portion. The retention sleeve includes a catheter socket configured to selectively receive the catheter shaft. For instance, the catheter socket mechanically engages the catheter shaft while the catheter shaft is received in the catheter socket. Accordingly, the scoring device retains the catheter shaft within the catheter socket.

The catheter socket of the scoring device selectively receives the catheter shaft. In contrast, in some approaches the catheter shaft is affixed (e.g., attached, glued, fused, or the like) with the catheter socket and the catheter shaft is not separable from the catheter socket. As described herein, the selective reception of the catheter shaft by the catheter socket of the scoring device facilitates loading and separation of the catheter shaft from the scoring device. Thus, the catheter socket interchangeably receives one or more catheter shafts. For instance, the catheter socket interchangeably receives a first catheter shaft having a first profile, and a second catheter shaft having a second profile (different than the first profile). Accordingly, the scoring device interchangeably retains one or more catheter shafts. Thus, catheters of varying profiles are attached to the scoring device.

In another example, the scoring device includes a deformable catheter port. The deformable catheter port is elastically deformable, for example to receive the catheter shaft. For instance, the catheter socket may selectively receive the catheter shaft through the deformable catheter port. In an example, the catheter port extends between an exterior of the retention sleeve and the catheter socket. The catheter port receives catheter shafts of varying profiles (e.g., a first catheter shaft having a first size, and a second catheter shaft having a second size) because the catheter port is elastically deformable and the elastic deformation permits the catheter port (and the catheter socket) to receive and accommodate catheter shafts of varying profiles.

The scoring device includes a scoring tool. In an example, the scoring tool is coupled with the retention sleeve proximate to the distal portion. The scoring tool includes a balloon socket that selectively receives a balloon of the catheter shaft. The scoring tool includes one or more scoring elements. Optionally, the scoring elements are directed away from the balloon socket. The scoring elements provide localized scoring to vasculature when deployed with a loaded balloon that is inflated. For instance, the scoring elements mechanically deform plaque within a vein, for instance to facilitate removal of the plaque.

As described herein, the balloon socket selectively receives a balloon of the catheter shaft. In an example, the balloon includes a deflated configuration and an inflated configuration. The balloon is expandable (e.g., enlargeable, growable, dilatable, stretchable, or the like) between the deflated and inflated configurations. For example, in the inflated configuration, a volume of the balloon is larger than the volume of the balloon in the deflated configuration. The scoring tool expands outward in conformity with the balloon (with the balloon located in the balloon socket). For example, the scoring tool includes an initial configuration and an expanded configuration. In an example, expansion of the balloon (e.g., between the deflated and inflated configurations) facilitates transition of the scoring tool between the initial configuration and the expanded configuration. For instance, expansion of the balloon engages the balloon with the scoring tool and expands the scoring tool. As the balloon expands from the deflated configuration to the inflated configuration, the scoring tool expands in conformity with the balloon. Accordingly, in an example, transitioning of the balloon between deflated and inflated configurations correspondingly transitions the scoring tool between initial and expanded configurations.

In one example, the balloon socket selectively receives the balloon, for instance because the catheter is separate from the scoring device and loaded into the scoring device. For instance, the balloon socket selectively receives a balloon of a first catheter having a first profile. In an example, the first catheter includes a first catheter shaft having a first balloon, the first balloon having a first expanded volume. The first catheter is optionally interchanged with a second catheter, for instance by separating the first catheter from the scoring device. The second catheter has a second profile. For instance, the second catheter includes a second catheter shaft having a second balloon with a second expanded volume. The scoring device retains the second catheter shaft (e.g., with the retention sleeve selectively receiving and mechanically engaging the second catheter shaft), and the balloon socket selectively receives the second balloon. Accordingly, the scoring device is interchangeable with a plurality of catheters, each of the plurality of catheters optionally having a different profile.

<FIG> illustrates a side view of an example scoring device <NUM>. The scoring device <NUM> includes a proximal portion <NUM> and a distal portion <NUM>. The distal portion <NUM> includes a distal tip <NUM>. The scoring device <NUM> includes a scoring tool <NUM>. For example, the scoring tool <NUM> is coupled proximate to the distal portion <NUM> of the scoring device <NUM>.

The scoring tool <NUM> includes one or more scoring elements <NUM>, for instance a first scoring element 110A. The one or more scoring elements <NUM> provide localized scoring (e.g., scraping, scratching, deforming, dislodging, cutting, shaving, parting, dividing, macerating, or the like) to vasculature. For instance, the scoring elements <NUM> facilitate removal of matter (such as plaque) from vasculature of a patient. In an example, the scoring elements <NUM> score the matter (e.g., plaque, or the like) to facilitate dilation of a vessel and the matter or, in another example, to facilitate separation of the matter from the vasculature. Accordingly, the scoring tool <NUM> facilitates dilation (e.g., compression), removal of matter from the vasculature by scoring the matter with the scoring elements <NUM>.

In an example, the scoring tool <NUM> includes a plurality of sections <NUM>. For example, the scoring tool <NUM> includes a first section 112A, a second section 112B, and a third section 112C, In some examples, and as described herein the sections <NUM> have different profiles from other sections <NUM>. For example, the first section 112A includes a first scoring element profile (e.g., an elliptical profile, semicircular profile, elongate profile or the like) and the second section 112B includes a second scoring element profile (e.g., a helical profile, a screw profile, or the like).

The scoring device <NUM> includes a retention sleeve <NUM>. The retention sleeve <NUM> extends between the proximal portion <NUM> and the distal portion <NUM>. As described herein, the scoring device <NUM> retains a catheter shaft (e.g., the catheter shaft <NUM>, shown in <FIG>). For instance, the retention sleeve <NUM> includes a catheter socket (e.g., the catheter socket <NUM>, shown in <FIG>) that selectively receives and mechanically engages the catheter shaft to retain the catheter shaft in the retention sleeve <NUM> (and the scoring device <NUM>). As described herein, the scoring device <NUM> is configured to interchangeably fit and couple with various catheters to provide flexibility by marrying the scoring device <NUM> with various catheters selected by a physician.

<FIG> shows an example of a catheter <NUM>. In an example, the catheter <NUM> includes a catheter shaft <NUM> and a balloon <NUM>. In an example, the balloon <NUM> extends from the catheter shaft <NUM>. <FIG> shows the balloon in a deflated configuration. The balloon <NUM> is expandable between the deflated configuration and an inflated configuration (shown in <FIG>). In the deflated configuration, the balloon <NUM> has a first balloon profile <NUM> (e.g., one or more of cross-section, shape, size, dimensions, contour, radius, perimeter, circumference, diameter, outline, boundary, configuration, pattern, arrangement, thickness, deployment from the catheter shaft <NUM>, or the like). For instance, the balloon <NUM> has a first volume in the deflated configuration. In an example, the balloon <NUM> has a first characteristic <NUM> (e.g., length or the like). The balloon has a second characteristic <NUM> (e.g., a diameter, volume, cross-sectional area, shape, size, qualitative size relative to an inflated configuration or the like). In some examples, the first characteristic <NUM> and the second characteristic <NUM> provides the balloon <NUM> with the first balloon profile <NUM> (and the first volume).

The catheter <NUM> includes a proximal portion <NUM> and a distal portion <NUM>. For example, the balloon <NUM> is included in the distal portion <NUM> of the catheter <NUM>. In an example, the distal tip <NUM> of the scoring device <NUM> (shown in <FIG>) receives the distal portion <NUM> of the catheter <NUM>. For instance, the distal portion <NUM> of the catheter <NUM> includes distal coupling features <NUM>, for example a balloon tip. In another example, the distal tip <NUM> of the scoring device <NUM> (shown in <FIG>) receives the distal coupling features <NUM> of the catheter <NUM>. In one example, the distal portion <NUM> (and the distal coupling features <NUM>) is optionally seated in the distal tip <NUM> of the scoring device <NUM>. In an example, seating of the distal coupling features <NUM> aligns the distal portion <NUM> of the catheter <NUM> relative to the distal portion <NUM> of the scoring device <NUM>.

<FIG> shows another side view of the catheter <NUM> of <FIG>. As described herein, the balloon <NUM> is expandable between the deflated configuration (shown in <FIG>) and an inflated configuration (shown in <FIG>). In the inflated configuration, the balloon <NUM> has a second balloon profile <NUM>. In an example, the second balloon profile <NUM> is larger than the first balloon profile <NUM> (e.g., by volume, cross sectional area, size, shape, deployment from the catheter shaft <NUM> or the like). For instance, the balloon <NUM> has a second volume in the inflated configuration, and the second volume is larger than the first volume of the balloon <NUM> in the deflated configuration. In one example, in the inflated configuration, the balloon <NUM> has a third characteristic <NUM> (e.g., length), and the third characteristic <NUM> is larger than the first characteristic <NUM> (shown in <FIG>). The balloon <NUM> has a fourth characteristic <NUM> (e.g., diameter, volume, cross-sectional area, shape, size, qualitative size relative to a deflated configuration or the like) in the inflated configuration. The fourth characteristic <NUM> is larger than the second characteristic <NUM>. In some examples, the third characteristic <NUM> and the fourth characteristic <NUM> provides the balloon <NUM> with the second balloon profile <NUM> (and the second volume). Accordingly, a transition of the balloon <NUM> between the deflated and inflated configurations correspondingly transitions the balloon <NUM> between having the first balloon profile <NUM> (shown in <FIG>) and having the second balloon profile <NUM> (shown in <FIG>). Thus, the volume of the balloon <NUM> transitions between the first volume in the deflated configuration, and the second volume in the inflated configuration. In an example, a change in volume of the balloon <NUM> includes one or more of a change in length, height, width, cross-sectional area, or the like of the balloon <NUM>.

<FIG> illustrates a detailed side view of the scoring device <NUM> of <FIG>, according to an embodiment of the present subject matter. As described herein, the scoring device <NUM> includes the retention sleeve <NUM>. In an example, the retention sleeve <NUM> facilitates retention of a catheter shaft (e.g., the catheter shaft <NUM>, shown in <FIG>) by the scoring device <NUM>.

In an example, the retention sleeve <NUM> includes a catheter socket <NUM>. The catheter socket <NUM> is configured to receive a catheter shaft, for instance the catheter shaft <NUM> (shown in <FIG>). The catheter socket <NUM> mechanically engages the catheter shaft, for example when the catheter shaft is received in the catheter socket <NUM>. In another example, the catheter socket <NUM> grasps the catheter shaft to facilitate retention of the catheter shaft by the retention sleeve <NUM> (e.g., during loading, use of the assembly or the like).

As described herein, the scoring device <NUM> includes the scoring tool <NUM>. In an example, the scoring tool <NUM> includes a balloon socket <NUM>. The balloon socket <NUM> selectively receives a balloon, for instance the balloon <NUM> (shown in <FIG>). The scoring elements <NUM> surround the balloon socket <NUM>, and with the balloon <NUM> loaded into the scoring device <NUM>, the scoring elements <NUM> surround the balloon including continuously and discontinuously. In another example, the scoring elements <NUM> are directed away from the balloon socket <NUM>. For example, the scoring elements <NUM> include a scoring edge <NUM>. In one example, the scoring edge <NUM> of the scoring elements <NUM> is directed away from the balloon socket <NUM>, for instance to minimize engagement of the scoring edge <NUM> with the balloon <NUM>. In another example, the balloon socket is located on a first side (e.g., an interior side, or the like) of the scoring element <NUM>, and the scoring edge <NUM> is located on a second side (e.g., an exterior side, opposed side or the like) of the scoring element <NUM>. Optionally, the scoring edge <NUM> is located remotely relative to the balloon socket <NUM> to minimize interaction with the balloon <NUM>.

<FIG> illustrates a top view of the scoring device <NUM> of <FIG>, according to an embodiment of the present subject matter. As described herein, the scoring tool <NUM> includes the catheter socket <NUM> (shown in <FIG>). The catheter <NUM> includes a catheter port <NUM> that provides access to the catheter socket <NUM>, for instance through the retention sleeve <NUM>. The catheter port <NUM> is in communication with the catheter socket <NUM>. In an example, the catheter port <NUM> is elastically deformable, for instance to facilitate ingress (or egress) of the catheter shaft into (our out of) the catheter socket <NUM>. As further shown in <FIG>, in this example the catheter port <NUM> of the scoring device includes an elongate slot extending through the retention sleeve <NUM>. The retention sleeve <NUM> is deformable and biases the port <NUM> (e.g., the slot) toward a closed configuration that captures a loaded catheter shaft within the catheter socket <NUM>. As described herein, a loading assembly biases the port <NUM> open, for instance with biasing of a catheter shaft, to initiate loading of the catheter shaft to the catheter socket <NUM> and continue loading through the port <NUM> (e.g., a slot) along the retention sleeve <NUM>.

<FIG> illustrates a detailed top view of the scoring device <NUM> of <FIG>, including the interface between the retention sleeve and the scoring tool <NUM>. As described herein, the scoring device <NUM> includes the catheter port <NUM>, and the catheter port <NUM> is in communication with the catheter socket <NUM>. In an example, the catheter port <NUM> facilitates selective reception of a catheter shaft by the retention sleeve <NUM>. For instance, the catheter port <NUM> (e.g., the retention sleeve <NUM> forming the port) is elastically deformable to facilitate ingress (or egress) of the catheter shaft into (or out of) the catheter socket <NUM>. In one example, the catheter port <NUM> includes a first face <NUM> and a second face <NUM> (also shown in <FIG>). The first face <NUM> is opposed to the second face <NUM>. The first face <NUM> and the second face <NUM> extend between the proximal portion <NUM> and the distal portion <NUM>. A slot <NUM> is optionally located between the opposed first and second faces <NUM>, <NUM>. In one example, the catheter port <NUM> is the slot <NUM> extending at least a portion of the length of the retention sleeve <NUM> (e.g., between the proximal and distal portions).

Elastic deformation of the catheter port <NUM> varies a size of port <NUM>, for instance by changing spacing between the first face <NUM> and the second face <NUM>. In this example, because the catheter port <NUM> is elastically deformable, the catheter port <NUM> is configured to receive a variety of catheter shafts having different profiles (e.g., diameters, cross sectional areas or the like). Accordingly, the catheter port <NUM> facilitates interchangeable reception of catheter shafts having varying profiles. For instance, elastic deformation of the catheter port <NUM> allows the catheter socket <NUM> to interchangeably receive a first catheter shaft having a first profile, a second catheter shaft having a different second profile or the like. Thus, catheter shafts are interchangeably received in the catheter socket <NUM> and loaded and unloaded through the catheter port <NUM> (and deformation of the port).

<FIG> illustrates a side view of the distal portion <NUM> of the scoring device <NUM> of <FIG>, according to an embodiment of the present subject matter. In an example, the distal portion <NUM> includes the distal tip <NUM>. In another example, the distal portion <NUM> of the scoring device <NUM> includes a distal tip socket <NUM>. The distal tip socket <NUM> receives a portion of a catheter, for instance the catheter <NUM> (shown in <FIG>). In one example, the distal portion <NUM> of the catheter <NUM> (shown in <FIG>) is optionally seated in the distal tip socket <NUM> of the scoring device <NUM>.

As discussed herein, the catheter <NUM> includes the distal coupling features <NUM> (shown in <FIG>). In an example, the distal tip socket <NUM> receives the distal coupling features <NUM>. For instance, the distal tip socket <NUM> includes a tapered portion <NUM> that receives the distal coupling features <NUM> of the catheter <NUM>. In another example, the tapered portion <NUM> that receives the distal coupling features <NUM> aligns the distal portion <NUM> of the catheter <NUM> relative to the distal tip socket <NUM>. Further, in some examples, the distal coupling features <NUM> are seated in the tapered portion <NUM>, for example with an interference fit, with complementary profiles or the like between the distal coupling features <NUM> and the tapered portion <NUM>. Accordingly, the distal portion <NUM> of the catheter <NUM> is optionally seated in the distal tip socket <NUM>.

<FIG> illustrates a cross-sectional view of the scoring device <NUM> of <FIG> at the line <NUM>-<NUM>, according to an embodiment of the present subject matter. As described herein, the retention sleeve <NUM> includes the first face <NUM> opposed to the second face <NUM>. For example, the retention sleeve <NUM> extends arcuately from the first face <NUM> to the second face <NUM>. Optionally, the retention sleeve <NUM> has an arcuate cross section interrupted with the catheter port <NUM>. In another example, the catheter port <NUM> is located between the first face <NUM> and the second face <NUM>. In some examples, the catheter port <NUM> includes the slot <NUM> (e.g., an elongate slot, or the like), and the slot <NUM> extends along the first face <NUM> and the second face <NUM>. In one example, elastic deformation of the retention sleeve <NUM> varies the size of the port <NUM> (or slot <NUM>), for instance by changing spacing between the first face <NUM> and the second face <NUM>. The catheter port <NUM> is in communication with the catheter socket <NUM>, and the catheter port <NUM> facilitates ingress (or egress) of a catheter shaft into (or out of) the catheter socket <NUM>. Additionally, as described herein the bias provided by the retention sleeve <NUM> facilitates retention of the catheter shaft within the catheter socket <NUM> during loading and use of the assembled device (e.g., catheter and scoring device). For instance, the retention sleeve <NUM> biases the catheter port <NUM> (or slot <NUM>) toward the initial position shown in <FIG>, and accordingly grasps and retains the catheter shaft therein.

<FIG> shows the catheter socket <NUM> has a first socket profile <NUM> (e.g., one or more of length, cross-section, shape, size, dimensions, contour, radius, perimeter, circumference, diameter, outline, boundary, configuration, pattern, arrangement, thickness or the like). As described herein, the socket profile <NUM> varies with elastic deformation of the retention sleeve <NUM>. For instance, the socket profile <NUM> is varied to change a volume of the catheter socket <NUM> and thereby accommodate various catheter shafts.

<FIG> illustrates an example of catheter assembly <NUM>, according to an embodiment of the present subject matter. In an example, the catheter assembly <NUM> includes the scoring device <NUM> and the catheter <NUM>. As described herein, the scoring device <NUM> retains a catheter shaft, for instance the catheter shaft <NUM>. For example, the catheter socket <NUM> selectively receives the catheter shaft <NUM> through the catheter port <NUM>. In another example, the retention sleeve <NUM> is elastically deformable to facilitate reception of the catheter shaft <NUM>.

For example, <FIG> shows the retention sleeve <NUM> in an initial configuration. In the initial configuration, the catheter socket <NUM> has the first socket profile <NUM>. Elastic deformation of the catheter port <NUM> facilitates reception of the catheter shaft <NUM> by the catheter socket <NUM>. For example, in the initial configuration, the first face <NUM> is proximate the second face <NUM>. Optionally, elastic deformation separates the first face <NUM> from the second face <NUM>, for instance to vary a characteristic <NUM> of the catheter port <NUM>.

Further, <FIG> shows the catheter shaft <NUM> of the catheter <NUM> having a first shaft profile <NUM>. In an example, elastic deformation of the retention sleeve <NUM> allows the socket profile <NUM> to correspond with the shaft profile <NUM>. Accordingly, the retention sleeve <NUM> mechanically engages the catheter shaft <NUM>, for instance when the catheter shaft is selectively received by the catheter socket <NUM>. For example, the mechanical engagement of the catheter socket <NUM> with the catheter shaft <NUM> constrains relative movement between the catheter shaft <NUM> and the retention sleeve <NUM>. In one example, the mechanical engagement constrains rotational movement of the catheter shaft <NUM> about a longitudinal axis of the retention sleeve <NUM>. In another example, the mechanical engagement constrains lateral movement of the catheter shaft along the longitudinal axis of the retention sleeve <NUM>. In yet another example, the retention sleeve <NUM> grasps the catheter shaft <NUM> to facilitate the catheter socket <NUM> mechanically engaging the catheter shaft <NUM>. The retention sleeve <NUM> accordingly joins the scoring device <NUM> with the catheter <NUM> and consolidates the separate devices (scoring device <NUM> and catheter <NUM>) in a unitary assembly for use by the physician.

<FIG> illustrates another example of the catheter assembly <NUM> of <FIG>, according to an embodiment of the present subject matter. As described herein, the retention sleeve <NUM> is elastically deformable. For instance, the retention sleeve includes a loading configuration, and in loading configuration the retention sleeve is elastically deformed relative to the initial configuration (shown in <FIG>). In an example, in the loading configuration the first face <NUM> and the second face <NUM> are biased apart (and the retention sleeve <NUM> is correspondingly deformed) relative to the initial configuration (shown in <FIG>, where the first face <NUM> is proximate the second face <NUM>). Accordingly, the profile of the catheter socket <NUM> is varied from the first socket profile <NUM> (shown in <FIG>) to a second socket profile <NUM>.

For instance, a user (e.g., a technician, healthcare worker, physician or the like) engages (e.g., presses, pushes, squeezes, or the like and optionally using a loading device described herein) the catheter shaft <NUM> with the first and second faces <NUM>, <NUM> to separate the first face <NUM> from the second face <NUM>. Accordingly, the elastically deformed retention sleeve <NUM> having the catheter port <NUM> facilitates reception of the catheter shaft <NUM> through the catheter port <NUM>. Thus, <FIG> shows the retention sleeve <NUM> in a loading configuration, and the catheter shaft <NUM> is at least partially located within the catheter socket <NUM> (e.g., the catheter shaft at least partially intersects the catheter socket <NUM>).

As described herein, elastic deformation of the retention sleeve <NUM> varies a profile of the catheter socket <NUM>. For instance, <FIG> shows the retention sleeve <NUM> in the loading configuration, and the catheter socket <NUM> has a second socket profile <NUM>. In an example, the second socket profile <NUM> (shown in <FIG>) is larger than the first socket profile <NUM> (shown in <FIG>) because of the elastic deformation of the retention sleeve <NUM>.

<FIG> illustrates yet another example of the catheter assembly <NUM> of <FIG>, according to an embodiment of the present subject matter. <FIG> shows the catheter shaft <NUM> selectively received (e.g., loaded) within the catheter socket <NUM> of the retention sleeve <NUM>. For instance, the first socket profile <NUM> corresponds with the first shaft profile <NUM>. Accordingly, the catheter socket <NUM> mechanically engages the catheter shaft <NUM>, and the catheter shaft <NUM> is retained by the scoring device <NUM>.

<FIG> illustrates still yet another example of the catheter assembly <NUM> of <FIG>, according to an embodiment of the present subject matter. In an example, the catheter assembly <NUM> includes a second catheter <NUM><NUM> having a second catheter shaft <NUM>. The second catheter shaft <NUM> has a second shaft profile <NUM> larger than the first shaft profile <NUM> (shown in <FIG>). For example, a diameter of the second catheter shaft <NUM><NUM> is larger than a diameter of the first catheter shaft <NUM>. In another example, the second catheter shaft <NUM> is longer than the first catheter shaft <NUM>. In yet another example, the catheter shaft <NUM> is longer and has a larger diameter than the first catheter shaft <NUM>.

Referring to <FIG>, the socket profile <NUM> corresponds to the shaft profile <NUM>. The socket profile <NUM> corresponds with the shaft profile <NUM> because the retention sleeve <NUM> is elastically deformable. The elastic deformation of the retention sleeve <NUM> enlarges the socket profile <NUM> and allows the catheter socket <NUM> (shown in <FIG>) to interchangeably receive catheters (or portions of catheters) having varied profiles. Accordingly, the scoring device <NUM> retains catheters with varying profiles, for example the first catheter <NUM> with the first shaft profile <NUM> (shown in <FIG>) or the second catheter <NUM> with the second shaft profile <NUM> (shown in <FIG>).

<FIG> illustrates a side view of the scoring tool <NUM> of the scoring device <NUM><NUM>, according to an embodiment of the present subject matter. The scoring device <NUM> includes the scoring tool <NUM> extending between proximal and distal portions <NUM>, <NUM> (shown in <FIG>). The scoring tool <NUM> includes the sections <NUM>, such as the sections 112A, 112B, 112C. The scoring tool <NUM> includes one or more scoring elements <NUM>, for example the first scoring element 110A and a second scoring element 110B. In an example, two or more of scoring elements <NUM> (e.g., elements 110A, 110B) are included in a scoring array <NUM>. For example, the scoring array <NUM> includes scoring elements with varying scoring element profiles <NUM>. In one example, the first section 112A of the scoring tool <NUM> includes a first scoring section 1302A, as shown having a longitudinally extending configuration of scoring elements. The second section 112B of the scoring tool <NUM> includes a second scoring section 1302B, for instance a helical configuration of scoring elements. The second scoring section 1302B has a first scoring element profile 1304A (e.g., helical profile, elliptical profile, semicircular profile, or the like). For instance, the second scoring section 1302B includes the first scoring element 110A, and the first scoring element 110A has the first scoring element profile 1304A. The third section 112C of the scoring tool <NUM> includes a third scoring section 1302C. The third scoring section 1302C has a second scoring element profile 1304B (e.g., an elongate profile or the like). For example, the third scoring section includes the second scoring element 110B, and the second scoring element 110B has the second scoring element profile 1304B similar or identical to the profile 1304B of the first scoring section 1302A.

Referring to <FIG>, the first scoring element 110A is optionally coupled with the second scoring element 110B. In another example, the first scoring section 112A includes a third scoring element 110C, and the third scoring element 110C is coupled with the first scoring element 110A. For instance, a first end <NUM> of the first scoring element 110A is coupled with the third scoring element 110C. A second end <NUM> of the first scoring element 110A is coupled with the second scoring element 110B. Accordingly, the scoring section 1302B extends between the scoring sections 1302A and the scoring section 1302C.

<FIG> illustrates the catheter <NUM> retained by the scoring device <NUM>, according to an embodiment of the present subject matter. For instance, the balloon <NUM> of the catheter <NUM> is loaded within the balloon socket <NUM> (also shown in <FIG> and <FIG>), and the scoring device <NUM> retains the catheter <NUM> therein (e.g., with the retention sleeve <NUM>). The scoring device <NUM> including the scoring elements <NUM> (and the catheter <NUM> including the balloon <NUM>) are navigated through the vasculature <NUM>, for instance a vein, artery, or the like. In some approaches, matter such as plaque <NUM> is adhered (e.g., bound, stuck, attached, compacted, or the like) to the vasculature <NUM>, for instance to a wall <NUM> of the vasculature <NUM>. As described herein, the balloon <NUM> and the scoring tool of the scoring device <NUM> are provided in a compressed or deflated configuration and the balloon <NUM> is inflated to an expanded or inflated configuration that also deploys the scoring tool <NUM>. <FIG> shows the balloon <NUM> in the deflated configuration (also shown in <FIG>).

<FIG> illustrates another example of the catheter <NUM> retained by the scoring device <NUM>, according to an embodiment of the present subject matter. <FIG> shows the balloon <NUM> in the inflated configuration (also shown in <FIG>) and shows the scoring tool <NUM> in an expanded configuration conforming to inflation of the balloon <NUM>. For example, the balloon <NUM> is enlarged to engage the scoring elements <NUM> with one or more of the vasculature <NUM> or the plaque <NUM> adhered to the vasculature <NUM>. Accordingly, the scoring tool <NUM> facilitates scoring of the plaque <NUM>. The balloon <NUM> and the scoring tool <NUM> work in concert to dilate the vessel. In one example, the scoring tool <NUM> separates or subdivides the plaque <NUM> to facilitate dilation of the plaque <NUM> with the inflated balloon <NUM>. Thus, the scoring tool <NUM> enhances treatment of plaque <NUM> from the vasculature <NUM> including, but not limited to, dilation of vessels (compression of plaque <NUM>), removal of plaque or the like.

<FIG> illustrates an example of the catheter assembly <NUM> with the first catheter <NUM> and the scoring device <NUM>, according to an embodiment of the present subject matter. <FIG> shows the balloon <NUM> in the deflated configuration and with the first balloon profile <NUM>. In an example, the balloon <NUM> of the catheter <NUM> is selectively received in the balloon socket <NUM> of the scoring device <NUM> and the scoring device <NUM> retains the catheter <NUM> therein (e.g., with the retention sleeve <NUM>. For instance, the scoring elements <NUM> are directed away from the balloon <NUM> selectively received in the balloon socket <NUM>.

Referring to <FIG>, the scoring tool includes an initial configuration and an expanded configuration. In the initial configuration, the scoring tool has a first tool profile <NUM>. For instance, the balloon <NUM> is selectively received in the balloon socket <NUM> with the balloon <NUM> in the deflated configuration.

<FIG> illustrates another example of the catheter assembly <NUM> with the first catheter <NUM> and the scoring device <NUM>, according to an embodiment of the present subject matter. <FIG> shows the balloon <NUM> in the inflated configuration and with the second balloon profile <NUM>. The balloon <NUM> and the scoring tool <NUM> work in concert to dilate the vessel. In one example, the scoring tool <NUM> separates or subdivides matter (such as plaque) to facilitate dilation of the matter with the inflated balloon <NUM>. In an example, the scoring tool <NUM> expands outward in conformity with the expansion of the balloon <NUM> to the inflated configuration. In another example, the scoring tool <NUM> accommodates the balloon <NUM> transitioning between the deflated and inflated configurations. For instance, the expansion of the balloon <NUM> radially displaces the scoring elements <NUM>. Thus, the scoring tool <NUM> has a second tool profile <NUM> with the balloon <NUM> in the inflated configuration (and having the second balloon profile <NUM>). The second tool profile <NUM> is larger than the first tool profile <NUM>. For example, the scoring elements <NUM> are radially displaced to increase spacing between the scoring elements <NUM> (in comparison to the initial configuration) and provide the scoring tool <NUM> with the second tool profile <NUM>. Accordingly, the balloon socket <NUM> selectively receives the balloon <NUM> with varying balloon profiles (e.g., one or more of the balloon profiles <NUM>, <NUM>).

<FIG> illustrates an example of the catheter assembly <NUM> with the second catheter <NUM> and the scoring device <NUM>, according to an embodiment of the present subject matter. The second catheter <NUM> includes a second balloon <NUM> that includes deflated and inflated configurations. The balloon <NUM> has a third balloon profile <NUM> in the deflated configuration. For example, the third balloon profile <NUM> includes a first initial volume for the second balloon <NUM>. Referring to <FIG>, the first balloon profile <NUM> includes a second initial volume for the first balloon <NUM>, In an example, the first balloon profile <NUM> is smaller than the third balloon profile <NUM>. Thus, the scoring tool <NUM> has a third tool profile <NUM> with the balloon <NUM> in the deflated configuration (and having the third balloon profile <NUM>). The third tool profile <NUM> is optionally, larger than the first tool profile <NUM>.

<FIG> shows the balloon <NUM> in the deflated configuration and with the first balloon profile <NUM>. In an example, the balloon <NUM> of the catheter <NUM> is selectively received in the balloon socket <NUM> of the scoring device <NUM><NUM>. Accordingly, the balloon socket <NUM> selectively receives the balloons, for instance the balloon <NUM> or the balloon <NUM> with varying balloon profiles (e.g., one or more of the balloon profiles <NUM>, <NUM>, <NUM>).

<FIG> illustrates another example of the catheter assembly <NUM> with the second catheter <NUM><NUM> and the scoring device <NUM>, according to an embodiment of the present subject matter. <FIG> shows the balloon <NUM> in the inflated configuration with a fourth balloon profile <NUM>. In an example, the scoring tool <NUM> expands outward in conformity with the expansion of the balloon <NUM> (or the balloon <NUM>, shown in <FIG>) to the inflated configuration. In another example, the scoring tool <NUM> accommodates the balloon <NUM> transitioning between the deflated and inflated configurations. Thus, the scoring tool <NUM> has a fourth tool profile <NUM> with the balloon <NUM> in the inflated configuration (and having the fourth balloon profile <NUM>). The fourth tool profile <NUM> is larger than the third tool profile <NUM>. For example, the scoring elements <NUM> are radially displaced to increase spacing between the scoring elements <NUM> (in comparison to the initial configuration) and provide the scoring tool <NUM> with the fourth tool profile <NUM>. Accordingly, the balloon socket <NUM> selectively receives the balloon <NUM><NUM> (or the balloon <NUM>) with varying balloon profiles (e.g., one or more of the balloon profiles <NUM>, <NUM>, <NUM>, <NUM>).

<FIG> illustrate side and detailed plan views (respectively) of another example of the scoring device <NUM>, according to an embodiment of the present subject matter. In an example, the scoring device <NUM> includes at least one longitudinal expansion region <NUM>. As shown in this example, the longitudinal expansion region <NUM> includes one or more expansion ribbons <NUM> that elastically deform and facilitate expansion of the scoring tool <NUM> (e.g., expansion from the initial configuration to the expanded configuration). The expansion ribbons <NUM> in one example include a serpentine or concertina configuration that facilitates elastic expansion and contraction that maintains the scoring tool <NUM> in conformance with the balloon in both inflated and deflated configurations and intermediate configurations therebetween. Additionally, as described herein the expansion ribbons <NUM> permit inflation of a balloon received in the balloon socket of the scoring tool <NUM> while minimizing interference of inflation that may affect the specified inflation configuration of the balloon (e.g., by binding, anchoring or the like with struts or features that fail to expand).

In one example, the expansion ribbons <NUM> facilitate one or more of axial or radial expansion of the scoring tool <NUM>. The expansion of the scoring tool <NUM><NUM> from the initial configuration to the expanded configuration in some examples axially expands and radially expands the scoring tool. For instance, the radius of the balloon perimeter relative to the catheter shaft enlarges through inflation of the balloon. The scoring tool <NUM> shown in <FIG> expands to accommodate the enlargement. Because the radius of the balloon increases during expansion and the scoring tool <NUM> is coupled along the balloon, the scoring tool follows the increase in radius (at both ends of the balloon) and thereby lengthens with the expansion ribbons <NUM> to accommodate the change in balloon radius while minimizing interference with balloon inflation.

In an example, the expansion ribbons <NUM> are isolated from proximate expansion ribbons <NUM>. For example, the scoring tool <NUM> includes a first ribbon 2002A isolated from a second ribbon 2002B. Instead, the first and second ribbons 2002A, B separately extend between scoring elements or other components of the scoring tool <NUM>. In another example, the first ribbon 2002A is not directly coupled with the second ribbon 2002B. Accordingly, the first ribbon 2002A is allowed to expand axially independently of the axial expansion of the ribbon 2002B. Thus, axial expansion of the scoring tool <NUM> is enhanced, for instance because the first ribbon 2002A does not bind with the second ribbon 2002B while the scoring tool transitions between initial and expanded configurations. Additionally, each of the ribbons <NUM> independently conforms to changes in the balloon during inflation without interference from proximate ribbons <NUM>.

In another example, the ribbons <NUM> extend helically around the balloon socket <NUM>. Helically winding the ribbons <NUM> around the balloon socket <NUM> minimizes sagging or separation of the scoring tool <NUM> from a balloon (e.g., the balloon <NUM>, shown in <FIG>) selectively received within the balloon socket <NUM>. Accordingly, retention and engagement of the scoring tool <NUM> to the loaded balloon is enhanced with helical wrapping of the balloon socket (and the balloon therein) with the ribbons <NUM>. Additionally, performance of the scoring device <NUM> is enhanced, because the scoring tool <NUM> mechanically engages the balloon in each of the deflated and inflated configurations (and intermediate configurations) and helical winding of the ribbons <NUM> around the balloon socket <NUM> enhances the mechanical engagement between the scoring tool <NUM> and the balloon and thereby facilitates enhanced conformance of the scoring tool <NUM> to the profile of the balloon.

<FIG> illustrates an example of a loading assembly <NUM>, according to an embodiment of the present subject matter. For instance, the loading assembly <NUM> includes an assembly tool <NUM> that facilitates assembly of a catheter assembly, for example the catheter assembly <NUM> (shown in <FIG>), having the scoring device <NUM> described herein and one or more catheters (e.g., balloon catheters). In an example, the assembly tool <NUM> facilitates assembly of the scoring device <NUM> to a catheter, for instance the catheter <NUM> (shown in <FIG>) or the catheter <NUM> (shown in <FIG>). For example, the assembly tool <NUM> facilitates elastic deformation of the catheter port <NUM> (shown in <FIG>) and ingress of the catheter <NUM> into the catheter socket <NUM> of the scoring device <NUM>. Accordingly, the assembly tool <NUM> facilitates reception of a balloon within the balloon socket of the scoring device <NUM>, opening of the scoring device <NUM>, and loading of the catheter shaft into the retention sleeve for retention of the shaft therein. Thus, the assembly tool <NUM> facilitates assembly of the scoring device <NUM> with a plurality of catheters, each of the catheters having different profiles.

In an example, the assembly tool <NUM> includes an assembly interface <NUM>. The assembly interface <NUM> receives each of the retention sleeve <NUM> and the catheter <NUM> in separated or partially separated conditions. For instance, the assembly interface <NUM> facilitates assembly of the retention sleeve <NUM> over the catheter shaft <NUM>.

In an example, the loading assembly <NUM> includes a scoring tool sheath <NUM> coupled with the assembly tool <NUM>. For instance, the scoring tool sheath <NUM> surrounds and protects the scoring tool <NUM> of the scoring device <NUM><NUM>. The scoring tool sheath <NUM> extends between the assembly interface <NUM> and a distal portion of the loading assembly <NUM>.

In another example, the loading assembly <NUM> includes a catheter loading mandrel <NUM>. The catheter loading mandrel <NUM> facilitates alignment of components of the loading assembly <NUM>. For instance, the mandrel <NUM> facilitates axial alignment of the scoring device <NUM> with the catheter <NUM>. The catheter loading mandrel <NUM> is optionally coupled with the scoring tool sheath <NUM>. For example, the catheter loading mandrel <NUM> extends through the assembly tool <NUM> (and the assembly interface <NUM>) from an opposed end of the scoring tool sheath <NUM>. Optionally, the catheter loading mandrel <NUM> extends through one or more of the catheter socket <NUM> of the retention sleeve <NUM> or the balloon socket <NUM> of the scoring tool <NUM>. For instance, the catheter loading mandrel <NUM> extends between the proximal and distal portions <NUM>, <NUM> of the scoring device <NUM> and is within the catheter and balloon sockets <NUM>, <NUM> of the scoring device. In some examples, the distal tip socket <NUM> of the scoring device passes the catheter loading mandrel <NUM> through the balloon socket <NUM>. The mandrel <NUM> optionally extends through the distal tip socket <NUM>, for example through the mandrel lumen <NUM> of the distal portion <NUM> of the scoring device <NUM>. Accordingly, the mandrel <NUM> extends through one or more components of the loading assembly <NUM> to facilitate alignment (and assembly) of the scoring device <NUM> and the catheter <NUM>.

<FIG> illustrates a cross-sectional view the loading assembly <NUM> including the assembly interface <NUM>, according to an embodiment of the present subject matter. In an example, the assembly interface <NUM> includes a loading interface <NUM> and an assembly fitting <NUM>. The loading interface <NUM> facilitates assembly of the catheter assembly <NUM>, for example by aligning the retention sleeve <NUM> with the mandrel <NUM>. In one example, the mandrel <NUM> is at least partially received in the catheter socket <NUM>. In an example, the mandrel <NUM> elastically deforms the catheter port <NUM> and the retention sleeve to facilitate ingress of the catheter shaft <NUM> into the catheter socket <NUM>. Thus, the mandrel <NUM> facilitates assembly of the catheter assembly <NUM> by assisting in the elastic deformation of the retention sleeve. Accordingly, the mandrel <NUM> facilitates the catheter socket <NUM> selectively receiving the catheter shaft <NUM> by elastically deforming the retention sleeve <NUM> and aligning the catheter <NUM> relative to the scoring device <NUM>. In another example, the catheter loading mandrel <NUM> guides the balloon (e.g., the balloon <NUM>) of the catheter through the assembly tool <NUM> and into the balloon socket <NUM> of the scoring tool <NUM>.

As described herein, the assembly interface <NUM> includes the assembly fitting <NUM>. The assembly fitting <NUM> facilitates assembly of the retention sleeve <NUM> over the catheter <NUM>. For instance, the assembly fitting <NUM> receives each of the retention sleeve <NUM> and the catheter <NUM>, with the sleeve <NUM> and the catheter <NUM> in a decoupled configuration. In an example, the decoupled configuration includes the catheter shaft <NUM> separate from the catheter socket <NUM> of the scoring device <NUM>. In another example, the balloon of the catheter is received within the balloon socket <NUM> of the scoring tool <NUM>. For instance, the mandrel <NUM> guides the balloon (e.g., the balloon <NUM>) of the catheter through the assembly tool <NUM> and into the balloon socket <NUM> of the scoring tool <NUM>.

In another example, the mandrel <NUM> and the loading interface <NUM> cooperate to align the retention sleeve <NUM> relative to the catheter shaft <NUM>. The assembly fitting <NUM> receives each of the retention sleeve <NUM> and the catheter <NUM> (for instance the catheter shaft <NUM>) and assembles the retention sleeve over the catheter <NUM> to provide an assembled configuration to the catheter assembly <NUM>.

In an example, the assembly fitting <NUM> is a collet <NUM> that extends around the retention sleeve <NUM> and the catheter <NUM>. For instance, the assembly collet <NUM> is compressible (e.g., elastomeric, squeezable, shrinkable, squishable, or the like) to assemble the retention sleeve <NUM> over the balloon catheter <NUM>. In another example, the assembly fitting <NUM> biases the retention sleeve <NUM> over the catheter <NUM>. For instance, the assembly fitting <NUM> opens an elongate slot (e.g., the slot <NUM>, shown in <FIG>) through radial compression around each of the retention sleeve and the catheter <NUM>. The compression biases the catheter <NUM> through the catheter port <NUM> of the retention sleeve (e.g., an elongate slot extending along the retention sleeve). In yet another example, opening the elongate slot facilitates reception of the catheter <NUM> within the retention sleeve <NUM> because elastic deformation of the retention sleeve <NUM> allows ingress (or egress) of the catheter shaft <NUM> into the catheter socket <NUM>. Thus, the assembly fitting <NUM> facilitates loading of the catheter <NUM> to the scoring device <NUM> by driving the catheter <NUM> through the catheter port <NUM> and into the catheter socket of the retention sleeve <NUM>.

In another example, the assembly fitting <NUM> is forced (e.g., pushed, extruded, compressed, pulled, drawn, or the like) through the loading interface <NUM>, for instance to compress the assembly fitting <NUM> (and assemble the scoring device <NUM> with the catheter <NUM>). For instance, the assembly interface <NUM> is rotatably coupled relative to the assembly collet <NUM>. In one example, the assembly interface <NUM> is rotatably coupled with the loading interface <NUM>. The assembly fitting <NUM> is received in the loading interface <NUM>, and rotation of the assembly interface <NUM> compresses the assembly fitting <NUM> with the loading interface <NUM>. For example, the assembly collet <NUM> is forced through a compression orifice <NUM> of the loading interface <NUM>. The compression orifice <NUM> includes a constriction (e.g., reduction in cross-sectional area, or the like) within the loading interface <NUM>, and forcing of the collet <NUM> through the orifice <NUM> compresses the assembly collet <NUM>. For instance, the collet <NUM> is deformable, and compression of the collet <NUM> deforms the collet <NUM> to engage the collet <NUM> with components received therein (e.g., one or more of the retention sleeve <NUM>, the catheter, or the mandrel <NUM>, or the like). In an example, the loading assembly evenly applies a force across the catheter assembly as the collet <NUM> is forced through the orifice <NUM> (e.g., the collet <NUM> is compressed concentrically around a perimeter of the collet <NUM>). In another example, assembly fitting <NUM> clamps the retention sleeve <NUM> to the catheter <NUM>, for instance by compressing the collet <NUM> with one or more components of the catheter <NUM> located in the collet <NUM>. Accordingly, the clamping of the retention sleeve to the catheter <NUM> minimizes separation of the retention sleeve <NUM> from the catheter <NUM>.

As discussed herein, rotation of the assembly interface <NUM> compresses the assembly fitting <NUM>. For instance, the loading assembly <NUM> includes an assembly drive <NUM>, and rotation of the assembly interface <NUM> displaces the assembly drive <NUM> relative to the loading interface <NUM>. The assembly interface <NUM> (and the assembly drive <NUM>) are rotatably coupled with the assembly fitting <NUM>, and in an example, the displacement of the assembly drive <NUM> compresses the assembly collet <NUM> by engaging with the collet <NUM> to force the collet <NUM> through the compression orifice <NUM> of the loading interface <NUM>. For instance, a barrel of the assembly drive <NUM> engages with the assembly fitting <NUM> (in this example the collet <NUM>). Optionally, the barrel of the assembly drive <NUM> is received by a corresponding barrel socket of the loading interface <NUM>. Accordingly, the assembly fitting <NUM> transitions the retention sleeve <NUM> and the catheter from the decoupled configuration to the assembled configuration. Thus, the loading assembly <NUM> facilitates biasing of the retention sleeve <NUM> over the catheter to assemble the catheter assembly <NUM> (shown in <FIG>).

Referring to <FIG>, in an example the loading assembly <NUM> includes a cutter <NUM>. For instance, the cutter <NUM> includes a sleeve cutting element <NUM> received in a sleeve cutting housing <NUM>. In an example, the sleeve cutting housing <NUM> is coupled with the assembly tool <NUM>, for instance coupled with the loading interface <NUM>. In another example, the sleeve cutting element <NUM> is positioned along the retention sleeve <NUM>, and the retention sleeve <NUM> passes through the sleeve cutting element <NUM>. As described herein, the catheter assembly <NUM> includes a decoupled configuration and an assembled configuration. In the decoupled configuration, the retention sleeve <NUM> passes through a cutting orifice (e.g., the cutting orifice <NUM>, shown in <FIG>) of the sleeve cutting element <NUM>. A user engages with the cutter <NUM>, for instance to rotate the sleeve cutting element <NUM> relative to the sleeve cutting housing <NUM>. In an example, rotation of the sleeve cutting element <NUM> severs the retention sleeve <NUM>. For instance, the sleeve cutting element <NUM> proximate the cutting orifice engages with the retention sleeve <NUM> to sever (e.g., cut, slice, chop, shear, or the like) the retention sleeve <NUM>. Thus, in the assembled configuration, the sleeve cutting element severs the retention sleeve <NUM>, for instance to trim the retention sleeve <NUM> to a specified length (e.g., to a retention sleeve length corresponding to a length of a catheter shaft). Accordingly, the retention sleeve <NUM> is severed proximate the catheter, for example to facilitate marriage of the retention sleeve <NUM> with the catheter.

<FIG> illustrates a detailed side view of the distal portion <NUM> of the loading assembly <NUM>, according to an embodiment of the present subject matter. As described herein, the mandrel <NUM> extends through the balloon socket <NUM> of the scoring device <NUM>, and the scoring elements <NUM> surround the balloon socket <NUM>. The scoring device <NUM> includes the distal portion <NUM>, and the mandrel <NUM> extends through the distal portion <NUM> of the scoring device <NUM> (e.g., through a distal tip socket, or the like).

<FIG> illustrates the loading assembly <NUM> including the catheter <NUM>, according to an embodiment of the present subject matter. For instance, the catheter <NUM> is loaded onto the mandrel <NUM>, and the mandrel <NUM> facilitates assembly of the catheter with the scoring device <NUM>. For instance, the mandrel <NUM> guides the balloon <NUM> (shown in <FIG>) of the catheter <NUM> through one or more of the catheter socket <NUM> or the balloon socket <NUM>. Thus, the balloon optionally extends through the balloon socket <NUM> and the distal portion <NUM> of the catheter <NUM> is seated into the distal portion <NUM> of the scoring device <NUM> (e.g., the balloon <NUM> is engaged with the tapered portion <NUM> of the distal tip socket <NUM>, shown in <FIG>). <FIG> illustrates the distal portion <NUM> of the loading assembly <NUM>, according to an embodiment of the present subject matter. The balloon <NUM> is optionally located in the balloon socket <NUM>, and into the distal tip socket <NUM> of the scoring device <NUM>.

<FIG> illustrates a side view of an example of the loading assembly <NUM> with the scoring tool sheath <NUM> and the assembly interface <NUM> separated from the assembly tool <NUM>, according to an embodiment of the present subject matter. For instance, rotation of the assembly interface <NUM> facilitates separation of one or more of the assembly interface <NUM>, the sheath <NUM>, or the mandrel <NUM> from the assembly tool <NUM>. The catheter <NUM> optionally includes a hub <NUM>, and in some examples the hub is engaged with the loading interface <NUM> (e.g., by pulling the catheter <NUM> through the assembly tool <NUM>). In another example, the catheter, such as the catheter shaft <NUM> and the hub <NUM> are moved through the assembly tool <NUM>. For instance, the catheter <NUM> is loaded into the scoring device <NUM>. The distal portions <NUM>, <NUM> of the catheter <NUM> and the scoring device are moved (e.g., pushed, pulled, or the like) relative to the assembly tool <NUM> and the retention sleeve <NUM> is biased over the catheter shaft <NUM> of catheter <NUM>. Movement of the catheter assembly <NUM> relative to the assembly tool <NUM> optionally engages the hub <NUM> with the loading interface <NUM> (shown in <FIG>).

<FIG> illustrates a detailed perspective view of the loading assembly <NUM>, according to an embodiment of the present subject matter. In an example, the assembly interface <NUM> includes a locking feature <NUM> that engages with the loading interface <NUM> to attach the assembly interface <NUM> with the assembly tool <NUM>. For instance, the assembly interface <NUM> includes a socket <NUM> that receives the locking feature <NUM> to attach the assembly interface <NUM> with the assembly tool <NUM>. In an example, rotation of the assembly interface <NUM> disengages the locking feature <NUM> from the socket <NUM>, for instance to facilitate separation of one or more of the assembly interface <NUM>, the sheath <NUM>, or the mandrel <NUM> from the assembly tool <NUM>. <FIG> shows the catheter shaft <NUM> on a first (e.g., distal, or the like) side of the assembly tool <NUM>. Additionally, the balloon <NUM> is received in the balloon socket <NUM> on a second side of the scoring tool <NUM>.

<FIG> illustrates another detailed perspective view of the loading assembly <NUM>, according to an embodiment of the present subject matter. In an example, the assembly interface <NUM> includes drive coupling features <NUM>, and the assembly drive <NUM> includes corresponding interface coupling features <NUM>. The drive coupling features <NUM> engage with the interface coupling features <NUM>, for example to facilitate displacement of the assembly drive <NUM>. In an example, rotation of the assembly interface <NUM> correspondingly rotates the assembly drive <NUM> because the drive coupling features <NUM> are engaged with the interface coupling features <NUM>. Optionally, the assembly drive <NUM> is threadingly engaged with the loading interface <NUM>, and rotation of the assembly drive <NUM> displaces the assembly drive <NUM> relative to the loading interface <NUM>. Accordingly, the loading assembly <NUM> facilitates assembly of the catheter assembly <NUM>, for instance by transitioning the retention sleeve <NUM> (shown in <FIG>) and the catheter <NUM> from the decoupled configuration to tire assembled configuration. In an example, the retention sleeve and catheter in the assembled configuration extend from the assembly fitting <NUM>.

<FIG> illustrates another side view of the loading assembly <NUM> including the catheter <NUM>, according to an embodiment of the present subject matter. In an example, the catheter <NUM> and the scoring device <NUM> are displaced relative to the assembly tool <NUM> (e.g., by pulling the distal portion <NUM>, or the like). In another example, the hub <NUM> is engaged with the loading interface <NUM> by displacing the scoring device <NUM> and the catheter <NUM> relative to the assembly tool <NUM>. In an example, displacing the scoring device <NUM> and the catheter <NUM> facilitates assembly of the retention sleeve <NUM> over the catheter <NUM>, for instance by biasing the retention sleeve <NUM> over the catheter shaft <NUM>. Thus, the loading assembly <NUM> facilitates the selective reception of the balloon <NUM> within the balloon socket <NUM> (also shown in <FIG>) and the selective reception of the catheter shaft <NUM> within the catheter socket <NUM> (also shown in <FIG>).

<FIG> illustrates a side view of the loading assembly <NUM> including the cutter <NUM>, according to an embodiment of the present subject matter. In an example, the cutter <NUM> includes a cutting operator <NUM> (e.g., a handle, lever, switch, or the like) that operates the cutter <NUM> to sever the retention sleeve <NUM>. For instance, the cutting operator <NUM> is coupled with the sleeve cutting element <NUM> (also shown in <FIG>), and the cutting operator is rotated to correspondingly rotate the cutting element <NUM>. As described herein, rotation of the cutting element <NUM> severs the retention sleeve <NUM>. Accordingly, the cutter <NUM> facilitates trimming of the retention sleeve <NUM>, for instance to terminate the retention sleeve <NUM> proximate to the hub <NUM>. For example, the cutter <NUM> allows the scoring device <NUM> to retain a plurality of catheters (with each of the catheters having a different profile, such as the catheters <NUM>, <NUM> shown respectively in <FIG> and <FIG>), for instance because the cutter <NUM> allows the length of the retention sleeve <NUM> to be trimmed to correspond with a length of one or more of the plurality of catheters. Thus, in an example, the loading assembly <NUM> facilitates transitioning of the catheter assembly <NUM> between the decoupled and assembled configurations, with the catheter assembly <NUM> including a plurality of catheters (with each of the catheters having a different profile).

<FIG> illustrates a cross-sectional view of the loading assembly <NUM>, according to an embodiment of the present subject matter. The loading assembly <NUM> includes the cutter <NUM>, and the cutter <NUM> includes the sleeve cutting element <NUM>. The sleeve cutting element <NUM> includes a cutting orifice <NUM>. In the decoupled configuration, the retention sleeve <NUM> passes through the sleeve cutting element <NUM>. As described herein, the catheter assembly <NUM> includes a decoupled configuration and an assembled configuration. In the decoupled configuration, the retention sleeve <NUM> passes through the cutting orifice <NUM> of the sleeve cutting element <NUM>. A user engages with the cutter <NUM>, for instance by engaging with the cutting operator <NUM> (shown in <FIG>) to rotate the sleeve cutting element <NUM> relative to the sleeve cutting housing <NUM>. In an example, rotation of the sleeve cutting element <NUM> severs the retention sleeve <NUM>. For instance, the sleeve cutting element <NUM> proximate the cutting orifice <NUM> engages with the retention sleeve <NUM> to sever (e.g., cut, slice, chop, shear, or the like) the retention sleeve <NUM>. Thus, in the assembled configuration, the sleeve cutting element <NUM> severs the retention sleeve <NUM>, for instance to trim the retention sleeve <NUM> to a specified length (e.g., to a retention sleeve length corresponding to a length of a catheter shaft). Accordingly, the retention sleeve <NUM> is severed proximate the catheter, for example to facilitate marriage of the retention sleeve <NUM> with the catheter shaft <NUM>.

In an example, the hub <NUM> of the catheter <NUM> is at least partially received by the loading interface <NUM>. For instance, the loading interface <NUM> receives a portion of the hub to align the proximal portion of the catheter <NUM> relative to the proximal portion <NUM> of the scoring device <NUM>. Accordingly, in the assembled configuration the catheter assembly <NUM> includes one or more components of the loading assembly <NUM>, for instance the loading interface <NUM>.

<FIG> illustrates yet another side view of the loading assembly <NUM>, according to an embodiment of the present subject matter. In an example, one or more components of the loading assembly <NUM> are separable from other ones of the components of the loading assembly <NUM>. For instance, in the assembled configuration the loading interface <NUM> is separable from the cutter <NUM>. Accordingly, the cutter <NUM> (or other components of the loading assembly <NUM>) are optionally discarded once the catheter assembly <NUM> is transitioned to the assembled configuration.

<FIG> illustrate various views of another example of the loading assembly <NUM>. As described herein, the loading assembly <NUM> includes one or more of the assembly tool <NUM>, assembly interface <NUM>, and the loading interface <NUM>, or the assembly fitting <NUM>. The loading assembly <NUM> optionally includes the assembly drive <NUM>. In an example, the assembly interface <NUM> receives each of the retention sleeve <NUM> and the catheter <NUM> in separated or partially separated conditions. For instance, the assembly interface <NUM> facilitates assembly of the retention sleeve <NUM> over the catheter shaft <NUM>.

In an example, the assembly interface <NUM> is rotatably coupled relative to the assembly fitting <NUM>. In one example, the assembly interface <NUM> is rotatably coupled with the loading interface <NUM>. The assembly fitting <NUM> is received in the loading interface <NUM>, and rotation of the assembly interface <NUM> compresses the assembly fitting <NUM> with the loading interface <NUM>. For example, the assembly fitting <NUM> is forced through the compression orifice <NUM> of the loading interface <NUM>. The compression orifice <NUM> includes a constriction (e.g., reduction in cross-sectional area, or the like) within the loading interface <NUM>, and forcing of the assembly fitting through the orifice <NUM> compresses the assembly fitting <NUM>.

In one example, the loading interface <NUM> facilitates transitioning of the catheter assembly <NUM> from the decoupled configuration to the assembled configuration. For instance, the loading interface <NUM> biases the retention sleeve <NUM> over the catheter shaft <NUM>. In another example, the assembly fitting <NUM> guides the retention sleeve <NUM> onto catheter shaft <NUM> and loads the shaft <NUM> into the sleeve <NUM> similar to as discussed herein. In another example, the assembly interface <NUM> is rotated relative to the drive <NUM> and the interior (e.g., a barrel, or the like) of the assembly interface <NUM> is driven toward an affixation seal, such as the collet <NUM>. In one example, the assembly fitting <NUM> is the assembly interface <NUM>. In yet another example, longitudinal compression of the assembly interface <NUM> (or the collet <NUM>) causes inward compression of the assembly interface <NUM>, and corresponding compression of the retention sleeve <NUM> and the catheter <NUM>. Two or more of these fitting assembly examples can work together to ensure the seating of the catheter shaft <NUM> in the retention sleeve <NUM>. Accordingly, the loading assembly <NUM> facilitates transitioning of the catheter assembly <NUM> from the decoupled configuration to the assembled configuration.

<FIG> illustrates a diagram of a method <NUM> for assembling a scoring device to a catheter, including one or more of the scoring device <NUM> or the catheters <NUM>, <NUM> described herein. In describing the method <NUM>, reference is made to one or more components, features, functions and operations previously described herein. Where convenient, reference is made to the components, features, operations and the like with reference numerals. The reference numerals provided are exemplary and are not exclusive. For instance, components, features, functions, operations and the like described in the method <NUM> include, but are not limited to, the corresponding numbered elements provided herein and other corresponding elements described herein (both numbered and unnumbered) as well as their equivalents.

At <NUM>, the method <NUM> includes delivering a catheter shaft <NUM> of the catheter <NUM> into a catheter socket <NUM> of a scoring device <NUM>. At <NUM>, the method <NUM> includes delivering a balloon <NUM> of the catheter shaft <NUM> into a balloon socket <NUM> of the scoring device <NUM>. At <NUM>, the method <NUM> includes mechanically locking the catheter shaft <NUM> with a retention sleeve <NUM> of the scoring device <NUM>.

Several options for the method <NUM> follow. For instance, a force is optionally applied to the catheter shaft <NUM> to deliver the catheter shaft <NUM> into the balloon socket <NUM>. In another example, delivering the catheter shaft <NUM> into the catheter socket <NUM> includes delivering the catheter shaft <NUM> through a catheter port <NUM>. For instance, the catheter port <NUM> is in communication with the catheter socket <NUM> to facilitate reception of the catheter <NUM> by the scoring device <NUM>. The method <NUM> optionally includes expanding the scoring array <NUM> with the balloon <NUM> of the catheter <NUM> (e.g., between deflated and inflated configurations). In yet another example, mechanically locking the catheter shaft <NUM> with the retention sleeve <NUM> includes biasing the retention sleeve <NUM> over the catheter shaft <NUM>. For instance, biasing the retention sleeve <NUM> over the catheter shaft <NUM> includes delivering each of the retention sleeve <NUM> and the catheter shaft <NUM> into an assembly fitting, for instance the assembly fitting <NUM> of the loading assembly <NUM>. The assembly fitting <NUM> optionally biases the catheter shaft into the catheter socket through a catheter port.

The above description includes references to the accompanying drawings, which form a part of the detailed description.

Geometric terms, such as "parallel", "perpendicular", "round", or "square", are not intended to require absolute mathematical precision, unless the context indicates otherwise. Instead, such geometric terms allow for variations due to manufacturing or equivalent functions. For example, if an element is described as "round" or "generally round," a component that is not precisely circular (e.g., one that is slightly oblong or is a many-sided polygon) is still encompassed by this description.

Claim 1:
A scoring device (<NUM>) configured for retention of a catheter shaft (<NUM>), the scoring device comprising:
a proximal portion (<NUM>);
a distal portion (<NUM>), including a distal tip (<NUM>);
a retention sleeve (<NUM>) extending between the proximal and distal portions, the retention sleeve having a catheter socket (<NUM>) configured to selectively receive and mechanically engage the catheter shaft (<NUM>) and the retention sleeve being configured to extend from a shaft distal portion (<NUM>) to proximate to a hub (<NUM>) of the catheter shaft (<NUM>); and
a scoring tool (<NUM>) coupled with the retention sleeve (<NUM>) proximate to the distal portion (<NUM>) and located distally with respect to the retention sleeve (<NUM>), the scoring tool including:
a balloon socket (<NUM>) configured to selectively receive a balloon (<NUM>) of the catheter shaft (<NUM>); and
one or more scoring elements (<NUM>) extending around the balloon socket (<NUM>), the one or more scoring elements configured to provide localized scoring to vasculature.