Patent Description:
Elongated medical devices, such as catheters and guidewires, may be advanced through vasculature of a patient during a medical procedure, such as by a clinician applying an axial pushing force or a rotational force to a portion of the elongated medical device that is outside a body of the patient. For example, a catheter defining at least one lumen may be used to deliver another medical device and/or therapeutic agent within vasculature of a patient. As another example, a guidewire may be used as a guide for placement of a larger device or prosthesis.

<CIT> describes an enema tube and catheter. <CIT> describes a force detection method, apparatus and device. <CIT> describes a method and apparatus for detecting vascular conditions with a catheter. <CIT> describes a stylus for electronic devices.

The invention is as defined by independent claim <NUM>. Dependent claims disclose exemplary embodiments.

In some examples, the present disclosure describes devices, systems, and methods for determining the integrity (e.g., actual or representative flexibility and/or stiffness properties) of an elongated medical device, which can be used, for example, to demonstrate the integrity of elongated medical devices or compare the integrity of multiple elongated medical devices. The elongated medical device can include, for example, a catheter (e.g., a guide catheter, a guide extension catheters, a microcatheter, a push wire of a catheter, or a tubular catheter body), a guidewire, or other type of elongated medical device. In some examples, a device is configured to receive an elongated medical device and transfer a compressive force applied to the elongated medical device to a force sensor, which is configured to generate an electrical signal or other output that is indicative of the amount of compressive force applied to the elongated medical device.

For example, in some examples, a device is configured to receive an elongated medical device and position the elongated medical device relative to a touchscreen of a computing device. An amount of contact between a conductive element of the device and the touchscreen varies based on the compressive force applied to the elongated medical device when the elongated medical device is received within the device. In these examples, the touchscreen may be the force sensor and the computing device may be a force-sensing device.

In examples described herein, a computing device is configured to generate and present a graphical user interface that indicates a parameter that is representative of the compressive force applied to a force sensor by an elongated medical device via the conductive element, e.g., as a numerical force value or another quantitative indication, or as a qualitative indication. For example, the computing device may determine a parameter based on the amount of contact between the conductive element and the touchscreen and generate a graphical user interface indicating the determined parameter. In some examples, a user may determine, based on the displayed graphical user interface, a minimum force required to cause the elongated medical device to bend. In addition or instead, in some examples, processing circuitry of the computing device may automatically determine the minimum force required to cause the elongated medical device to bend based on the input received via the touchscreen, the input indicating an amount of contact between a conductive element and the touchscreen, which varies as a function of the force applied to the conductive element by the elongated medical device received within the body of the force transmission device.

Elongated medical devices, such as, but not limited to a catheter (or a part of a catheter, such as a push assembly or a tubular catheter body) or a guidewire, may be advanced through vasculature of a patient during a medical procedure. For example, a clinician may apply a pushing force to a proximal portion of the medical device to advance the medical device through the vasculature. Thus, the elongated medical device may be configured such that it is relatively flexible to enable the medical device to substantially conform to the curvature of the vasculature, yet stiff enough (e.g., has a sufficiently high columnar strength) to be advanced through vasculature by a pushing force applied to a proximal portion of the medical device without buckling or undesirable bending (e.g., kinking) of the medical device. In addition, in some examples, a clinician may steer an elongated medical device through the vasculature of a patient by rotating the elongated medical device. For example, the clinician may apply torque to the proximal portion of the elongated medical device (or at least a portion of the medical device that is more proximal than the distal portion implanted in the patient) in order to rotate the distal portion of the elongated medical device. Thus, in some cases, an elongated medical device has sufficient structural integrity to transmit the torque applied to a relatively proximal portion to a relatively distal portion.

For at least the reasons discussed above, the integrity (e.g., flexibility and/or stiffness) is a characteristic of an elongated medical device that may differentiate it from other elongated medical devices and may be indicative of its performance during a medical procedure. Described herein are devices and systems configured to quantitatively and/or qualitatively indicate the integrity of an elongated medical devices based on a compressive force applied to the elongated medical device, as well as devices (referred to as force transmission devices in some instances) configured to receive the elongated medical device and transmit a compressive force applied to the elongated medical device to a force sensor. The quantitative or qualitative indication of the integrity of an elongated medical device can be, for example, actual or representative flexibility and/or stiffness properties, such as, but not limited to, a numerical force value or another quantitative parameter of a compressive force that causes the elongated medical device to bend, or as a qualitative parameter that indicates a relative degree of flexibility and/or stiffness of the elongated medical device. In either the quantitative parameter example or the qualitative parameter example, the parameter determined by a computing device varies as a function of a compressive force applied to a conductive element of a force transmission device by an elongated medical device.

<FIG> is a conceptual side view of an example catheter <NUM>, which includes an elongate body <NUM>, a push assembly <NUM>, and a handle <NUM>. Elongate body <NUM> may include an inner liner and an outer jacket (not shown). As shown in <FIG>, elongate body <NUM> may define a proximal end <NUM> and a distal end <NUM>.

While the description of the devices, systems, and techniques described herein primarily refer to the catheter <NUM> of <FIG>, in other examples, the devices, systems, and techniques described herein may be used to determine the integrity of another elongated medical device, such as, but not limited to, a guidewire, a catheter that does not include a push assembly <NUM> and/or handle <NUM>, or a polymer tube used to form a catheter or other elongated medical device. For example, example catheter <NUM> may include a guide catheter, a microcatheter, or any other elongated medical device.

Elongate body <NUM> may be a distal portion of catheter <NUM>. Elongate body <NUM> defines at least one lumen through which a medical device (e.g., another catheter, guidewire, filter, stent delivery system, and the like), therapeutic agent, or other element can be introduced into vasculature or other tissue sites of a patient.

In some examples, catheter <NUM> may be part of an assembly that includes an outer catheter (not shown) defining a lumen through which catheter <NUM> may be introduced in order to access, for example, a distal target site within vasculature of a patient. Thus, at least a portion of the outer catheter may be configured to surround catheter <NUM>. The outer catheter may define a distal opening and, in some examples, at least a portion of elongate body <NUM> may be configured to extend through a lumen of the outer catheter and out the distal opening of the outer catheter, e.g., to effectively extend the reach of the outer catheter within vasculature of a patient and enable delivery of devices, agents, and/or any other suitable elements to target sites that may be difficult for the outer catheter to reach. For example, elongate body <NUM> may be fully or partially pushed through a lumen of the outer catheter until the entire or part of elongate body <NUM> extends past a distal end of the outer catheter, while push assembly <NUM> remains fully or partially within the lumen of the outer catheter.

In some examples, catheter <NUM> may be configured to extend out of the distal opening of the outer catheter to extend through heavy tortuosity or calcification within a body vessel. Catheter <NUM> may have a smaller radial profile and may be more flexible than the outer catheter, such that it may more easily navigate through heavy tortuosity or calcification within a body vessel than the outer catheter.

Push assembly <NUM> is configured to enable a clinician to position elongate body <NUM> with respect to an outer catheter and/or with respect to patient vasculature. For example, a proximal portion of push assembly <NUM> may be configured to be gripped and moved by the clinician to position (e.g., advance distally or proximally, and/or rotate) elongate body <NUM> within vasculature of a patient. In some examples, push assembly <NUM> may be used to advance elongate body <NUM> with respect to an outer catheter to advance elongate body <NUM> within the outer catheter and/or extend all or a portion of elongate body <NUM> distal of the outer catheter to access vasculature distal to the outer catheter. Accordingly, push assembly <NUM> may be configured to have a relatively high integrity relative to its low profile. In other words, push assembly <NUM> is configured such that it may receive a relatively high magnitude compressive force (e.g., a pushing force) while resisting bending (e.g., while remaining substantially straight), despite its narrow cross-sectional area. This may enable push assembly <NUM> to efficiently transmit a pushing force to elongate body <NUM>, which may in turn enable a clinician to relatively efficiently place catheter <NUM> at a target site within vasculature of a patient. In contrast, if push assembly <NUM> bends, then it may take longer and may be more difficult for a clinician to distally advance catheter <NUM> through vasculature, e.g., through an outer catheter or otherwise.

In some examples, elongate body <NUM> may include an inner liner and outer jacket that may provide multiple layers between which push assembly <NUM> may be inserted to attach push assembly <NUM> to elongate body <NUM>. This may provide for a relatively strong attachment between push assembly <NUM> and elongate body <NUM>, as well as maintain relatively smooth outer and inner surfaces of elongate body <NUM> at the portion of elongate body <NUM> attached to push assembly <NUM>.

Push assembly <NUM> has a lower profile than elongate body <NUM>, and, as a result, may occupy less space within the outer catheter lumen than elongate body <NUM>. Thus, push assembly <NUM> may both facilitate pushability of the catheter through the outer catheter and/or through vasculature of a patient, while still enabling relatively large medical devices to be introduced through the outer catheter lumen to reach the lumen of the catheter.

In some examples, push assembly <NUM> includes an elongate member 108A (also referred to herein as a shaft) and an anchor member 108B at a distal end of elongate member 108A. Anchor member 108B is configured to facilitate attachment of elongate member 108A to elongate body <NUM>. Anchor member 108B may be positioned at a distal end of the elongate member 108A in some examples. Elongate member 108A may be formed from any suitable material, such as, but not limited to, a metal, a polymer, or any combination thereof. For example, elongate member 108A may include a metal wire or a polymer hypotube.

In some examples described herein, systems and devices may enable a user to determine (e.g., measure) a compressive force that may be applied to push assembly <NUM> (e.g., elongate member 108A) without push assembly <NUM> bending. This compressive force may be referred to herein as a "maximum" compressive force, although it may not be an exact determination of a maximum force. The maximum compressive force may be equivalent to (or nearly equivalent to) the minimum compressive force that causes push assembly <NUM> to bend. Again, the minimum compressive force may not be an exact minimum compressive force that causes push assembly <NUM> to bend but provides an estimation of the actual minimum compressive force that is sufficient to indicate the relative integrity of the elongated medical device.

The maximum or minimum compressive force may be determined in substantially the same way for different elongated medical devices, such that it provides a representation of the integrity of the elongated medical device that can be used to compare the different elongated medical device. In some examples, systems and devices may enable a user to compare the relative flexibilities of two or more elongated medical devices, such as elongated medical devices having different configurations and/or elongated medical devices from different manufacturers. In some examples, the devices and systems described herein (e.g., including a force transmission device and a computing device) are relatively portable to enable easy transport of the devices and systems. For example, the devices and systems described herein may be small and light enough to fit in a user's clothing pocket or in a relatively small carrying case that is specially designed for the system or a standard carrying case such as a laptop bag.

<FIG> is a side view of an example system <NUM> that may be used to determine an integrity (e.g., actual or representative flexibility or stiffness parameters) of an elongated medical device, such as, but not limited to, push assembly <NUM> of catheter <NUM> (<FIG>). As discussed in further detail below, system <NUM> is configured to generate a graphical user interface that provides an indication of the relative integrity of an elongated medical device. In some examples, system <NUM> is configured to determine a minimum amount of compressive force necessary to cause an elongated medical device to bend, or equivalently, the maximum amount of compressive force that may be applied to the elongated medical device without causing the elongated medical device to bend.

System <NUM> includes force-transmission device <NUM> (also referred to herein as a "device" in some instances) and computing device <NUM>. Force-transmission device <NUM> is configured to receive an elongated medical device <NUM>, which may be, for example, an element of push assembly <NUM> (<FIG>), such as elongate member 108A, or another elongated medical device. While elongated medical device <NUM> is also referred to as a wire <NUM> herein, elongated medical device <NUM> may have any suitable configuration and may be formed from any suitable material, such as, but not limited to, a metal and/or a polymer. Force-transmission device <NUM> includes conductive element <NUM> and body <NUM> that is configured to support and align wire <NUM> with respect to conductive element <NUM>.

Computing device <NUM> may be any suitable electronic device configured to receive input from a force sensor indicative of a force applied to wire <NUM> (and transmitted to the force sensor via force-transmission device <NUM>) and generate an output based on the force, e.g., a parameter that varies based on a magnitude of the force, which can include a quantitative output (e.g., a numerical force value), a qualitative value (e.g., a color or other qualitative visual attribute that changes as a function of the amount of applied force), or a combination of a quantitative value and a qualitative output. In the example shown in <FIG>, the force sensor is a touch-sensitive screen ("touchscreen") <NUM> (depicted parallel to the x-y plane in <FIG>, where orthogonal x-y-z axes are shown in the figures for ease of description only). In other examples, however, other force sensors may be used, such as, but not limited to, a pressure transducer, a weighing scale, or a piezoelectric sensor, separate from a display screen of computing device <NUM>. Thus, while examples described herein primarily refer to a touchscreen, the devices, systems, and techniques described herein may be used with other type of pressure sensing devices.

In the example of <FIG>, computing device <NUM> is depicted as a mobile device, such as a smartphone or tablet. However, in other examples, computing device <NUM> may be another type of computing device. Computing device <NUM> includes any suitable components necessary to provide the functions described herein. In the example shown in <FIG>, computing device <NUM> includes processing circuitry <NUM>, and a computer-readable medium, such as memory <NUM>.

In some examples, touchscreen <NUM> may include a capacitive touchscreen. For example, touchscreen <NUM> may include an embedded grid of electrically conductive strips of material, such as indium tin oxide. Touchscreen <NUM> may be configured to detect a physical contact with an electrically conductive element, such as a finger of a human user or conductive element <NUM>, and generate an electrical signal indicative of the physical contact. While capacitive touchscreens are primarily referred to herein, in other examples, touchscreen <NUM> may include other types of touchscreens, such as, but not limited to a resistive touchscreen configured to detect an electrical connection when a portion of a layer of touchscreen <NUM> (e.g., an outer layer) is depressed against another layer (e.g., an inner layer) by a compressive force applied to the resistive touchscreen by a finger or conductive element <NUM>.

Conductive element <NUM> is electrically conductive and is configured to be detected by touchscreen <NUM> when conductive element <NUM> is placed in physical contact with the touch-sensitive portion of touchscreen <NUM>. In some examples, conductive element <NUM> comprises an electrically conductive silicone rubber. For example, conductive element <NUM> may include a conductive rubber tip (or "nib"), such as that of a stylus pen.

When wire <NUM> is received within body <NUM>, conductive element <NUM> is disposed between distal end <NUM> of wire <NUM> and touchscreen <NUM> of computing device <NUM>. Conductive element <NUM> is configured to receive a compressive force (e.g., in the negative-z-axis direction in <FIG>) applied to wire <NUM> (e.g., by a user or by a robotic arm other device), and in response, an amount of contact between conductive element <NUM> and touchscreen <NUM> changes. In this way, conductive element <NUM> may transfer an indication of that compressive force to a surface of touchscreen <NUM> by changing the amount of contact between conductive element <NUM> and the screen in response to the magnitude of the compressive force. For example, conductive element <NUM> may physically deform in response to the compressive force (e.g., flatten against touchscreen <NUM>).

Touchscreen <NUM> is configured to generate an electrical signal indicative of (e.g., that changes as a function of) an amount of contact between conductive element <NUM> and touchscreen. Thus, the electrical signal may also be indicative of a magnitude of the compressive force applied to wire <NUM> when wire is received in body <NUM> and in contact with conductive element <NUM>. In some examples, a greater compressive force may correspond to an increased conductive response by touchscreen <NUM>. For example, a larger compressive force may cause a physical deformation (e.g., a flattening, on the macroscopic level, of a rounded tip) of conductive element <NUM>, creating a larger area of contact between conductive element <NUM> and touchscreen <NUM>. As another example, a larger compressive force may cause an increase in electrical conductance between conductive element <NUM> and touchscreen <NUM>, due to an increased number of electrical connections at the microscopic level.

Computing device <NUM> is configured to receive data indicative of the electrical signal from touchscreen <NUM> and determine a parameter based on the data (e.g., an approximate magnitude of the compressive force) based on the electrical signal. In some examples, computing device <NUM> is configured to generate and present a graphical user interface (GUI) via touchscreen <NUM>, the GUI indicating the determined parameter (e.g., an example of which is discussed with reference to <FIG>). The determined parameter can be a quantitative value (e.g., a numerical value of the magnitude of force) or a qualitative value (e.g., a color or depth of color, or other visual indication) that varies based on the amount of contact between the conductive element and the touchscreen.

<FIG> is a perspective view of body <NUM> of device <NUM> of the system depicted in <FIG>. In some examples, body <NUM> may be configured to support an elongated medical device, such as push assembly <NUM> (<FIG>) or wire <NUM> (<FIG>). Body <NUM> may be relatively lightweight and portable as compared to some other integrity-testing devices. For example, body <NUM> may be made of plastic, such as a molded plastic, and may have at least one dimension that is smaller than a mobile device to enable body <NUM> to sit on a touchscreen of the mobile device. Body <NUM> may include a single piece of material, or multiple pieces of material fused, welded, or otherwise connected together.

In some examples, base <NUM> is configured to rest on a touchscreen <NUM> of computing device <NUM> (<FIG>). For example, base <NUM> may include a planar undersurface <NUM> configured to align with and sit directly on or indirectly on a planar surface of touchscreen <NUM>. In some examples, base <NUM> may include a relatively high-friction material on undersurface <NUM> to increase the static friction between base <NUM> and touchscreen <NUM> (e.g., a glass or plastic surface of touchscreen <NUM>). Thus, the relatively high-friction material may help minimize movement between base <NUM> and touchscreen <NUM>, e.g., during the application of compressive force to wire <NUM> received within body <NUM>. The relatively high friction material can be, for example, a coating applied to undersurface <NUM>, a material integrated into a material of base <NUM>, a surface treatment of underside <NUM> of body <NUM>, or a separate friction element applied (e.g., a non-conductive rubber and/or silicone) to undersurface <NUM>.

In the example shown in <FIG>, body <NUM> includes base <NUM> and arm <NUM> extending from base <NUM>. Base <NUM> and arm <NUM> are configured to support and align wire <NUM> with respect to touchscreen <NUM>. For example, base <NUM> may be configured to support and retain distal end <NUM> of wire <NUM>, and arm <NUM> may be configured to support wire <NUM> at a second point along its length. In some examples, arm <NUM> may be spaced far enough from base <NUM> to provide stability for wire <NUM>, but close enough to base <NUM> such that a majority of the length of wire <NUM> extends above arm <NUM> in the z-axis direction when wire <NUM> is received within body <NUM>. For example, arm <NUM> may be spaced approximately <NUM> millimeters (e.g., <NUM> millimeters to the extent permitted by manufacturing tolerances) from base <NUM> for a wire <NUM> having a length of approximately <NUM> millimeters. In other examples, arm <NUM> may be spaced relatively far from base <NUM>, such that a majority of wire <NUM> is disposed within a region between base <NUM> and arm <NUM> when wire <NUM> is received within body <NUM>. The distance between base <NUM> and arm <NUM>, as well as the length of wire <NUM> (measured from proximal to distal ends) may dictate where wire <NUM> bends in response to the compressive force applied to wire <NUM> in a direction towards touchscreen <NUM>.

Body <NUM> is configured to hold wire <NUM> (or another elongated medical device) relative to touchscreen <NUM>, e.g., in a substantially fixed x-y position (to the extent base <NUM> remains in place relative to touchscreen <NUM>) while a compressive force is being applied to wire <NUM>. For example, in some examples, base <NUM> defines base opening <NUM>, which is configured to receive distal end <NUM> of wire <NUM>, and arm <NUM> defines arm opening <NUM>, through which distal end <NUM> of wire <NUM> may be received to reach base opening <NUM>. For example, arm opening may have a diameter approximately two to three times as wide as wire <NUM> (e.g., as a widest cross-sectional dimension of wire <NUM>, such as a diameter of wire <NUM> in examples in which wire <NUM> has a circular cross-section). Arm opening <NUM> may be substantially aligned (e.g., sharing a common central axis as permitted by manufacturing tolerances) with base opening <NUM>, so as to receive a straight wire <NUM> (when no compressive force is being applied to wire <NUM>). When wire <NUM> is received in body <NUM> such that it extends through both base opening <NUM> and arm opening <NUM>, body <NUM> supports and aligns wire <NUM>, for example, along the z-axis depicted in <FIG>.

In some examples, base opening <NUM> may also be configured (e.g., sized and shaped) to receive and surround conductive element <NUM> (<FIG>), such that when wire <NUM> extends through both base opening <NUM> and arm opening <NUM>, conductive element <NUM> is positioned between distal end <NUM> of wire <NUM> and touchscreen <NUM>. In other examples, however, conductive element <NUM> can be positioned distal to base opening <NUM> (i.e., such that base opening <NUM> is between conductive element <NUM> and arm opening <NUM>).

<FIG> is a block diagram of an example computing device that is configured to determine a parameter based on data indicating an amount of contact between conductive element <NUM> and touchscreen <NUM> and generate and present a graphical user interface on touchscreen <NUM> indicating the parameter. In the example shown in <FIG>, computing device <NUM> includes touchscreen <NUM>, processing circuitry <NUM>, memory <NUM>, and power source <NUM>.

Touchscreen <NUM> is configured to receive an input from conductive element <NUM> indicative of a compressive force applied to conductive element <NUM> by wire <NUM> (e.g., as applied to the wire from a user). Touchscreen <NUM> is configured to generate a signal indicative of the input, e.g., an electrical signal that varies in at least one characteristic (e.g., amplitude or frequency) as a function of the amount of contact between conductive element <NUM> and touchscreen <NUM>, and provide the electrical signal to processor <NUM>. As discussed above, touchscreen <NUM> can be a capacitive touchscreen, configured to detect a change in its internal electric field, or a resistive touchscreen, configured to detect a contact between two internal conductive layers. In other examples, computing device <NUM> includes a non-touchscreen display and a separate force sensor. In these examples, the force sensor is configured to receive the input from conductive element <NUM>.

Processing circuitry <NUM> is configured to receive the electrical signal from touchscreen <NUM> indicative of a compressive force applied to conductive element <NUM> via wire <NUM> and determine a parameter based on the electrical signal. In some examples, the parameter can be, for example, a numerical value of the magnitude of the compressive force, a graphical representation of the magnitude, or a qualitative indication of the compressive force, such as a relative color scale.

For example, processing circuitry <NUM> may be configured to execute an algorithm to convert the electrical signal generated by touchscreen <NUM> into an approximate magnitude of the compressive force.

In some examples, processing circuitry <NUM> may store the determined parameter in memory <NUM>. Memory <NUM> may comprise any suitable medium, such as random-access memory (RAM), read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), electronically erasable programmable read-only memory (EEPROM), flash memory, comprising executable instructions for causing processing circuitry <NUM> to perform the actions attributed to it. For example, memory <NUM> may store instructions thereon, that, when executed by processing circuitry <NUM>, cause processing circuitry <NUM> to determine a magnitude of a compressive force applied to wire <NUM> based on an electrical signal received from touchscreen <NUM>. In some examples, memory <NUM> may encode a lookup table storing a set of values of magnitudes of compressive forces, as well as a set of respective electrical signals that may be received from touchscreen <NUM>.

<FIG> is a perspective view of the system <NUM> and illustrates a user applying a compressive force to wire <NUM> received by device <NUM>. <FIG> illustrates base <NUM> of body <NUM> of device <NUM> placed on touchscreen <NUM> (e.g., on an outer surface) of computing device <NUM>. A distal end <NUM> of wire <NUM> has been introduced through arm opening <NUM> and base opening <NUM>, until distal end <NUM> contacts conductive element <NUM>, such that it extends away from a major surface of touchscreen <NUM> in the z-axis direction. In examples in which wire <NUM> is substantially straight in an "at rest" position in which user <NUM> is not applying a compressive force to wire <NUM>, wire <NUM> may be substantially parallel to the z-axis (e.g., parallel but for manufacturing tolerances that result in a non-straight wire <NUM>).

User <NUM> may apply a compressive force (such as with a finger, in the negative-z-axis direction) to proximal end <NUM> of wire <NUM> or to a portion of wire <NUM> that is between proximal end <NUM> and arm <NUM> of device <NUM>. Once user <NUM> has applied a sufficient compressive force, wire <NUM> will bend, such as in the x-y plane (indicated in <FIG> by arrow <NUM> at the center of wire <NUM>, pointing in the y-axis direction). For example, arm <NUM> and base <NUM> may be spaced relatively close together, such that wire <NUM> tends to bend in a region above (in the z-axis direction) arm <NUM>. In other words, the majority of the length of wire <NUM> may be disposed in a region proximal to user <NUM> relative to arm <NUM>, providing space for wire <NUM> to bend. In other examples, arm <NUM> and base <NUM> may be spaced relatively far apart, such that wire <NUM> tends to bend in a region between arm <NUM> and base <NUM>. In other words, the majority of the length of wire <NUM> may be disposed in a region between arm <NUM> and base <NUM>, providing space for wire <NUM> to bend.

In response to the compressive force applied to wire <NUM> by user <NUM>, conductive element <NUM> may deform, increasing an amount of contact with touchscreen <NUM>. For example, the physical contact between conductive element <NUM> and touchscreen <NUM> may increase in surface area and/or pressure as a function of the compressive force applied to wire <NUM>. Touchscreen <NUM> is configured to output an electrical signal indicating the amount (e.g., area and/or pressure) of the contact with conductive element <NUM>. Thus, the electrical signal output by touchscreen <NUM> may also be indicative of a compressive force applied to conductive element <NUM> via wire <NUM>.

Processing circuitry <NUM> of computing device <NUM> receives the electrical signal from touchscreen <NUM> and determines a parameter based on the electrical signal. For example, processing circuitry <NUM> may determine an approximate measurement of the magnitude of the compressive force based on the electrical signal, such as by executing an algorithm relating the data from the touchscreen to a respective magnitude of a compressive force. In other examples, processing circuitry <NUM> may be configured to retrieve an entry from a lookup table stored by memory <NUM> relating electrical signals (or specific signal characteristics) generated by touchscreen <NUM> to a respective magnitude of a compressive force. Processing circuitry <NUM> may then generate and present a GUI on touchscreen <NUM>, the GUI comprising an output region that displays the determined parameter indicative of the compressive force.

In some examples, user <NUM> may visually determine (e.g., estimate) the magnitude of the applied compressive force at the point at which wire <NUM> bends, which may be the minimum compressive force that causes wire <NUM> to bend or the maximum compressive force that wire <NUM> can withstand before bending, as discussed above. For example, processing circuitry <NUM> may update the GUI at a rate (e.g., multiple times per second) that enables the GUI to reflect an amount of compressive force currently being applied to wire <NUM>. User <NUM> may subjectively estimate the first appearance of a curvature along wire <NUM>, and observe the force measurement presented on the GUI at or near that point in time to determine the magnitude of the applied compressive force at the point at which wire <NUM> bends.

In addition to or instead of user <NUM> determining the magnitude of the applied compressive force at the point at which wire <NUM> bends based on the force information displayed via the GUI, in some examples, processing circuitry <NUM> is configured to determine the applied compressive force at which wire <NUM> bends, which may be indicative of the integrity of wire <NUM>. For example, at the point at which the compressive force applied to wire <NUM> causes the wire to bend, the energy applied to wire <NUM> may be redirected into deformation (bending) of wire <NUM>, rather than into deformation of conductive element <NUM> against touchscreen <NUM>, and accordingly, the amount of contact between conductive element <NUM> and touchscreen <NUM> may temporarily stop increasing or otherwise changing in response to the increased force. Accordingly, in some examples, processing circuitry <NUM> may be configured to receive an electrical signal from touchscreen <NUM>, where a signal parameter of the electrical signal changes as a function of the contact between conductive element <NUM> and touchscreen <NUM>, and determine the point at which a signal parameter of the electrical signal stops changing, and determine the magnitude of the compressive force at that point. For example, processing circuitry <NUM> may be configured to determine a peak of magnitude of the electrical signal and determine that peak to be the magnitude of the applied compressive force at the point at which wire <NUM> bends.

Although force-transmission device <NUM> shown in <FIG>, <FIG>, and <FIG> is configured to hold wire <NUM> generally transverse (e.g., perpendicular) to a major surface of touchscreen <NUM>, in other examples, a force-transmission device can be configured to hold wire <NUM> generally parallel to major surface of touchscreen <NUM>. This may help better simulate the orientation of wire <NUM> during a medical procedure and provide a user with a more "real world" setting in which the relative integrity of wire <NUM> is determined.

<FIG> is a side view of a system <NUM> including another example force-transmission device configured to receive an elongated medical device and transfer a compressive force applied to the elongated medical device to a force-sensing device. System <NUM> includes force-transmission device <NUM> (detailed further with respect to <FIG>, below) and computing device <NUM>. In the example depicted in <FIG>, force-transmission device <NUM> is configured such that, unlike in the previous example, base <NUM> of body <NUM> does not rest on touchscreen <NUM>. Because conductive element <NUM> is the only object in physical contact with touchscreen <NUM>, the example system of <FIG> may provide more accurate measurements of a compressive force compared to system <NUM> shown in <FIG>. However, with either system, consistent methodology in obtaining data may be sufficient to account for touchscreen-related error.

Force-transmission device <NUM> includes body <NUM> and conductive element <NUM>. Body <NUM> is configured to receive an elongated medical device (e.g., wire <NUM>) and hold the elongated medical device <NUM> relative to touchscreen <NUM>. Body <NUM> is further configured to transfer (e.g., redirect) a compressive force applied to wire <NUM> (e.g., in the negative-x-axis direction) when wire <NUM> is received in body <NUM> to conductive element <NUM> (e.g., in the negative-z-axis direction).

<FIG> is a perspective view of body <NUM> of force-transmission device <NUM> of the system <NUM>. Body <NUM> may be made from any suitable material, such as, but not limited to plastic, such as a molded plastic. Body <NUM> includes base <NUM>, proximal arm 308A, distal arm 308B, and lever <NUM>.

Base <NUM> may include a relatively flat (e.g., planar) surface <NUM> configured to be aligned (e.g., in the x-y plane) with computing device <NUM> (<FIG>). For example, when in use, base <NUM> may be placed adjacent to computing device <NUM>, such as on top of a common planar surface. In some examples, base <NUM> includes planar surface <NUM>, configured to contact and rest on a common planar surface with computing device <NUM>. In some examples, <NUM> may include a friction-enhancing element, such as a rubber coating, to reduce or prevent body <NUM> from moving or slipping (in the x-y plane) with respect to computing device <NUM>.

Proximal and distal arms 308A, 308B are configured to receive and support respective ends of wire <NUM>. For example, proximal arm 308A may define proximal arm opening 310A configured to receive and support proximal end <NUM> of wire <NUM>, and distal arm 308B may define distal arm opening 310B configured to receive and support distal end <NUM> of wire <NUM>. Distal arm opening 310B may be substantially aligned (e.g., sharing a common central axis) with proximal arm opening 310A, so that a substantially straight wire <NUM> may be relatively easily extend through both openings 310A, 310B. Proximal arm 308A may be spaced apart from distal arm 308B such that, when wire <NUM> is received within body <NUM>, a majority of the length of wire <NUM> is disposed in a region between the two arms, such that wire <NUM> has space to bend within this region. Proximal arm opening 310A and distal arm opening 310B may be a common distance from base <NUM> (in the z-axis direction) such that wire <NUM> is disposed parallel to touchscreen <NUM> when wire <NUM> is received within body <NUM>. Proximal arm opening 310A may be, for example, approximately <NUM> centimeters (about four inches)(in the x-axis direction) from distal arm opening 310B.

Lever <NUM> defines recess 320A configured to receive distal end <NUM> of wire <NUM>. For example, recess 320A may be aligned with distal arm opening 310B, such that when wire <NUM> in a substantially linear configuration is inserted through distal arm opening 310B, wire <NUM> also extends through recess 320A. Recess 320A is not a through-hole, and defines a predetermined region for wire <NUM> to engage with lever <NUM> to cause lever <NUM> to move in response to a compressive force applied to wire <NUM>. In other examples, lever <NUM> may not define recess 320A, but, rather, distal end <NUM> of wire <NUM> may engage with an outer surface of lever <NUM>.

Lever <NUM> includes an element configured to redirect a compressive force from wire <NUM>, for example, from the negative-x-axis direction into the negative-z-axis direction. For example, lever <NUM> may be rotatably or pivotably connected, via hinge <NUM>, to distal arm 308B, such that lever <NUM> rotates toward the negative-z-axis direction when wire <NUM> contacts lever <NUM> in the negative-x-axis direction. In some examples, lever <NUM> is configured to receive conductive element <NUM>. However, in other examples, lever <NUM> and conductive element <NUM> may be the same component, such that conductive element <NUM> is pivotably connected to distal arm 308B, and is configured to directly receive distal end <NUM> of wire <NUM>.

In some examples, lever <NUM> includes lower set screw <NUM> and upper set screw <NUM> (depicted in <FIG>). Lower set screw <NUM> includes a threaded element configured to allow a user to adjust the height of conductive element <NUM> with respect to touchscreen <NUM> of computing device <NUM>. For example, lower set screw <NUM> may be rotated so as to partially enter or exit lever <NUM> such that, when conductive element <NUM> is resting on top of touchscreen <NUM>, lever <NUM> is in physical contact with distal arm 308B at contact point <NUM>. Once lower set screw <NUM> has been adjusted to the proper height, upper set screw <NUM> may be inserted into lever <NUM> to secure lower set screw <NUM> in place.

In some examples, device <NUM> includes Tuohy-Borst Adaptor <NUM>, configured to receive and support distal end <NUM> of wire <NUM>. However, other examples of device <NUM> may not include Tuohy-Borst Adaptor <NUM>.

<FIG> is a side view of the system of <FIG> and illustrates a user applying a compressive force to an elongated medical device <NUM> received within the force-transmission device <NUM>. User <NUM> removes upper set screw <NUM> to unlock lower set screw <NUM>. User <NUM> places base <NUM> of device <NUM> adjacent to computing device <NUM>, such that conductive element <NUM> is above touchscreen <NUM> (e.g., in the positive z-axis direction). User <NUM> adjusts lower set screw <NUM> to a height at which conductive element <NUM> contacts touchscreen <NUM>, and lever <NUM> contacts distal arm 308B at contact point <NUM>. User <NUM> re-inserts upper set screw <NUM> until upper set screw <NUM> contacts lower set screw <NUM> to secure lower set screw <NUM> in place.

User <NUM> inserts distal end <NUM> of wire <NUM> through proximal arm opening 310A and distal arm opening 310B, until distal end <NUM> contacts lever <NUM>. User <NUM> applies a compressive force (such as with one or more fingers, in the negative-x-axis direction) to handle <NUM> at proximal end <NUM> of wire <NUM>. Lever <NUM> rotates in response to the contact from wire <NUM>, redirecting the compressive force from the negative-x-axis direction into the negative-z-axis direction, and onto touchscreen <NUM>.

In response to the compressive force, conductive element <NUM> may deform, increasing an amount of contact with touchscreen <NUM>. For example, the physical contact between conductive element <NUM> and touchscreen <NUM> may increase in both area and/or pressure as a function of the compressive force applied to wire <NUM>. Touchscreen <NUM> is configured to output an electrical signal, e.g., data, indicating the amount (e.g., area and/or pressure) of contact with conductive element <NUM>.

Computing device <NUM> receives the data from touchscreen <NUM> and determines an approximate measurement of the magnitude of the compressive force based on the data. For example, computing device <NUM> may be configured to execute an algorithm relating the data from the touchscreen to a respective magnitude of a compressive force. In other examples, computing device <NUM> may be configured to retrieve an entry from a lookup table relating the data from the touchscreen to a respective magnitude of a compressive force. Computing device may then output the measurement via a GUI displayed on touchscreen <NUM>.

Once user <NUM> has applied a sufficient compressive force, wire <NUM> will bend, such as in the y-z plane between proximal arm 308A and distal arm 308B (indicated in <FIG> by the thick black arrow pointing in the z-axis direction).

In some examples, user <NUM> may visually determine (e.g., estimate) the magnitude of the applied compressive force at the point at which wire <NUM> bends. For example, the GUI may continuously update to reflect the amount of compressive force currently being applied to wire <NUM>. User <NUM> may subjectively estimate the first appearance of a curvature along wire <NUM>, and observe the force measurement on the GUI at that point.

In other examples, computing device <NUM> may be configured to quantitatively estimate and store the minimum applied compressive force required for wire <NUM> to bend. For example, at the point at which the compressive force applied to wire <NUM> causes the wire to bend, the energy applied to wire <NUM> may be redirected into deformation (bending) of wire <NUM>, rather than into deformation of conductive element <NUM> against touchscreen <NUM>, and accordingly, the amount of contact between conductive element <NUM> and touchscreen <NUM> may temporarily stop increasing or otherwise changing in response to the increased force. Accordingly, computing device <NUM> may be configured to monitor the signal received from touchscreen <NUM> and determine the point at which the signal stops changing, and determine the magnitude of the compressive force at that point.

<FIG> illustrates an example GUI <NUM> that may be generated and displayed by a computing device of any of the systems described herein. For example, processing circuitry <NUM> may generate and present GUI <NUM> on touchscreen <NUM> of computing device <NUM> (<FIG>). GUI <NUM> includes input region <NUM> and output region <NUM>. Input region <NUM> graphically indicates an area on which a user may place surface <NUM> of base <NUM> of body <NUM> of device <NUM> (<FIG>). For example, a user may place base <NUM> of device <NUM> within input region <NUM> such that conductive element <NUM> is aligned with contact point <NUM>. In other examples, user may place device <NUM> anywhere within input region <NUM>, or use contact point <NUM> as a visual guide for placement. Touchscreen <NUM> may detect an electrical signal from contact point <NUM> when conductive element <NUM> contacts contact point <NUM>.

Output region <NUM> includes an area configured to display an indication of a parameter indicative of compressive force, based on the amount of contact between the conductive element <NUM> and touchscreen <NUM>, determined by processing circuitry <NUM>. For example, processing circuitry <NUM> may determine an approximate magnitude of a compressive force based on an electrical signal generated by touchscreen <NUM> based on input received via contact point <NUM> of input region <NUM>, and GUI <NUM> may display the approximate magnitude as a numerical value within output region <NUM>. For example, GUI <NUM> may display the numerical value of the compressive force in units of Newtons (N) or Earth-gravities (g) within output region <NUM>. In some examples, GUI <NUM> may display a previously determined parameter, such as a force magnitude, for comparison with a current parameter.

<FIG> is another example GUI <NUM> that may be generated by processing circuitry <NUM> and displayed on touchscreen <NUM> of computing device <NUM>. GUI <NUM> may be configured to interact with system <NUM> of <FIG>.

GUI <NUM> includes input region <NUM> and output region <NUM>. Input region <NUM> graphically indicates an area of touchscreen <NUM> with which conductive element <NUM> can be aligned (<FIG>). For example, a user may place base <NUM> of device <NUM> next to computing device <NUM> such that when conductive element <NUM> pivots into contact with touchscreen <NUM>, conductive elements <NUM> contacts the portion of touchscreen <NUM> in which input region <NUM> is displayed.

Output region <NUM> includes an area configured to display an indication of a parameter based on an electrical signal indicating the amount of contact between the conductive element <NUM> and touchscreen <NUM> determined by processing circuitry <NUM>. For example, processing circuitry <NUM> may determine an approximate magnitude of a compressive force based on an electrical signal generated by touchscreen <NUM> based on input received via input region <NUM>, and GUI <NUM> may display the approximate magnitude as a numerical value within output region <NUM>. For example, GUI <NUM> may display the numerical value of the compressive force in units of Newtons (N), Earth-gravities (g), or gram-force (gf) within output region <NUM>. In some examples, GUI <NUM> may additionally or alternatively display the approximate magnitude graphically, such as with circular force meter <NUM>.

In examples in which computing device <NUM> is configured to determine the magnitude of the compressive force at which wire <NUM> begins to bend, GUI <NUM> may include reset button <NUM> and save button <NUM>, enabling a user to determine a new value of the magnitude, or store the currently determined value, respectively.

<FIG> are example GUIs 1100A, 1100B, and 1100C that may be generated by processing circuitry <NUM> and displayed on touchscreen <NUM> of computing device <NUM> in some examples. <FIG> depicts an example main "home" page 1100A that allows a user to select between a demonstration page (<FIG>) and an information page (<FIG>).

<FIG> depicts an example demonstration ("demo") page 1100B of a GUI. The demo page is a GUI display via which a user obtains data regarding the flexibility of an elongated medical device. For example, GUI 1100B may be GUI <NUM> (<FIG>) or GUI <NUM> (<FIG>). GUI 1100B includes an input region <NUM> and output region <NUM>. Input region <NUM> defines a predetermined area with which a user may align conductive element <NUM> and in which touchscreen <NUM> may receive input indicative of a compressive force applied to wire <NUM>. Output region <NUM> is configured to display one or more parameters indicative of the amount of compressive force applied to wire <NUM>, e.g., which processing circuitry <NUM> determines based on an amount contact between conductive element <NUM> and touchscreen <NUM>. For example, output region <NUM> may display an indication of the compressive force, as determined by computing device <NUM>. The indication may include a numerical value, a graphical indication, or a qualitative indication, such as a respective color that changes as a function of the amount of contact between touchscreen <NUM> and conductive element <NUM>.

<FIG> depicts an information ("info") page 1100C of a GUI. The information page is a GUI display enabling a user to view data acquired on demo page 1100B. For example, info page 1100C may display for comparing the determined force values acquired from multiple trials on demo page 1100B, which may be trials using the same medical device or different medical devices. In some examples, info page 1100C may be configured to display the determined force values for two or more similar elongated medical devices, such as two different wires <NUM>. Info page 1100C may display the results for comparison as numerical values or as graphical representations, such as bar graph <NUM>.

<FIG> is a flow diagram depicting an example method of determining the integrity of an elongated medical device, such as via system <NUM> depicted in <FIG>. User <NUM> places base <NUM> of body <NUM> of force-transmission device <NUM> onto touchscreen <NUM> of computing device <NUM> (<NUM>). User <NUM> inserts distal end <NUM> of wire <NUM> through arm opening <NUM> and into base opening <NUM>, until distal end <NUM> contacts conductive element <NUM> (<NUM>). User <NUM> applies a compressive force, such as with a finger, to proximal end <NUM> of wire <NUM> or to a portion of wire <NUM> between proximal end <NUM> and arm <NUM> (<NUM>). Once user <NUM> has applied a sufficient compressive force, wire <NUM> will bend. Processing circuitry <NUM> of computing device <NUM> receives an indication (such as an electrical signal) of the amount of contact between conductive element <NUM> and touchscreen <NUM>, and determines a parameter based on the indication, such as an approximate measurement of the magnitude of the compressive force. In some examples, processing circuitry <NUM> generates and presents a GUI (e.g., GUI <NUM> shown in <FIG> or GUI 1100B shown in <FIG>) that displays the parameter on touchscreen <NUM> for observation by user <NUM> (<NUM>).

<FIG> is a flow diagram depicting an example method of determining the integrity of an elongated medical device, such as via system <NUM> depicted in <FIG>. User <NUM> removes upper set screw <NUM> (<NUM>). User <NUM> places base <NUM> of device <NUM> adjacent to computing device <NUM>, such that conductive element <NUM> is above touchscreen <NUM> (<NUM>). User <NUM> adjusts lower set screw <NUM> to a height at which conductive element <NUM> contacts touchscreen <NUM>, and lever <NUM> contacts distal arm 308B at contact point <NUM> (<NUM>). User <NUM> inserts upper set screw <NUM> until upper set screw <NUM> contacts lower set screw <NUM> (<NUM>). User <NUM> inserts distal end <NUM> of wire <NUM> through proximal arm opening 310A and distal arm opening 310B, until distal end <NUM> contacts lever <NUM> (<NUM>). User <NUM> applies a compressive force, such as with one or more fingers, to proximal end <NUM> of wire <NUM> or to a portion of wire <NUM> between proximal end <NUM> and proximal arm 308A (<NUM>). Lever <NUM> rotates in response to the contact with wire <NUM>, redirecting the force onto touchscreen <NUM>. Once user <NUM> has applied a sufficient compressive force, wire <NUM> will bend, such as between proximal arm 308A and distal arm 308B (indicated in <FIG> by the thick black arrow pointing in the z-axis direction). Computing device <NUM> receives an indication (such as an electrical signal) of the compressive force via conductive element <NUM>, and determines an approximate measurement of the magnitude of the compressive force based on the indication. In some examples, computing device may output the measurement via a GUI displayed on touchscreen <NUM>, for observation by user <NUM> (<NUM>).

<FIG> is a flow diagram depicting a method of testing or measuring the flexibility of an elongated medical device. Although <FIG> is primarily described with reference to computing device <NUM>, in other examples, processing circuitry of another computing device alone or in combination with computing device <NUM> may perform any part of the techniques described herein.

In the method of <FIG>, processing circuitry <NUM> receives data from touchscreen <NUM>, where the data may include an electrical signal that changes as a function of an amount of contact (such as an area of contact or an amount of force or pressure) between conductive element <NUM> and touchscreen <NUM>, and, therefore, as a function of a compressive force applied to conductive element <NUM> by wire <NUM> (<NUM>). Other data from touchscreen <NUM> and received by processing circuitry <NUM> may indicate, for example, a location on the touchscreen.

Based on the received data, processing circuitry <NUM> determines a parameter, such as an approximate measurement of the magnitude of the compressive force applied to the wire (<NUM>). For example, computing device may compute a pre-determined algorithm relating the electrical signal to a magnitude of a compressive force. In another example, computing device <NUM> may retrieve, from a memory storage, an entry from a lookup table indicating a compressive force magnitude corresponding to the electrical signal.

In some examples, computing device <NUM> may be configured to monitor the signal received from the touchscreen and determine the point at which the corresponding compressive force stops increasing or otherwise changing, and store this value as the minimum compressive force required to cause the medical device to bend.

Computing device <NUM> may output the determined magnitude of the compressive force to a GUI for display on the touchscreen (<NUM>). For example, the GUI may display an indication of the compressive force as a numerical value, or as a graphical representation.

If implemented in software, the functions may be stored on or transmitted over, as one or more instructions or code, a computer-readable medium and executed by a hardware-based processing unit. Computer-readable media may include computer-readable storage media, which corresponds to a tangible medium such as data storage media, or communication media, which includes any medium that facilitates transfer of a computer program from one place to another, e.g., per a communication protocol. In this manner, computer-readable media generally may correspond to (<NUM>) tangible computer-readable storage media, which is non-transitory or (<NUM>) a communication medium such as a signal or carrier wave. A computer program product may include a computer-readable storage medium.

For example, if information is transmitted from a website, server, or other remote source using a coaxial cable, fiber optic cable, twisted pair, digital subscriber line (DSL), or wireless technologies such as infrared, radio, and microwave, then the coaxial cable, fiber optic cable, twisted pair, DSL, or wireless technologies such as infrared, radio, and microwave are included in the definition of medium.

Instructions may be executed by processing circuitry, e.g., one or more processors, such as one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry. Accordingly, the term "processor" and "processing circuitry" as used herein may refer to any of the foregoing structure or any other structure suitable for implementation of the techniques described herein. In addition, in some aspects, the functionality described herein may be provided within dedicated hardware and/or software modules.

The techniques of this disclosure may be implemented in a wide variety of devices or apparatuses.

Claim 1:
A device (<NUM>, <NUM>) comprising:
a body (<NUM>, <NUM>) configured to receive an elongated medical device (<NUM>); and
a conductive element (<NUM>) configured to contact a touchscreen (<NUM>) of a computing device (<NUM>), wherein an amount of contact between the conductive element (<NUM>) and the touchscreen (<NUM>) varies based on a compressive force applied to the elongated medical device (<NUM>) when the elongated medical device (<NUM>) is received within the body (<NUM>, <NUM>);
wherein the body is configured to support and align the elongated medical device and the conductive element such that the compressive force applied to the elongated medical device is transferred to the conductive element.