Balloon catheter with sensor elements

Abstract

A medical device system includes an elongated body configured to be inserted into a blood vessel of a patient. The medical device system includes an expandable structure at a distal portion of the elongated body. The medical device system includes a plurality of sensor elements of carried by the expandable structure including at least a first subset of sensor elements and a second subset of sensor elements that form a mesh of sensor elements. The medical device system further includes processing circuitry configured to receive, via the plurality of sensor elements, one or more signals. The processing circuity is configured to determine, based on the one or more signals, an indication of a morphology of a lesion of the blood vessel or a map of pressure values based on one or more pressures applied by a stent or a blood vessel wall against the expandable structure.

Description

PCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001BALLOON CATHETER WITH SENSOR ELEMENTS

[0001] This application claims priority to, and the benefit of, U.S. Provisional Application No. 63 / 688,072, filed August 28, 2024, and entitled “BALLOON CATHETER WITH SENSOR ELEMENTS,” the entire contents of which is incorporated herein by reference.TECHNICAL FIELD

[0002] This disclosure relates to medical catheters.BACKGROUND

[0003] Medical devices including stents, such as bare metal stents or drug coated stents, may be delivered to passages of the body (e.g., blood vessels, ureters and other hollow structures) and expanded to hold open the passage of the body. In some examples, stents are delivered to narrowed arteries to facilitate increased blood flow through the artery. Catheters may be used to deliver and / or expand stents at locations of interest.SUMMARY

[0004] This disclosure describes medical device systems including catheter systems configured to perform multiple functions during a medical procedure, such as a percutaneous coronary intervention (PCI) procedure. Such medical procedures can include stent delivery and expansion via a minimally invasive procedure using a catheter. For example, the systems described herein include catheter systems configured to both expand a balloon and / or a stent against a blood vessel wall as well as determine one or more clinically relevant parameters, measurements, or indices related to the blood vessel or the stent. The medical device systems described herein are configured to perform multiple functions while maintaining a small form factor, such that the systems remain able to navigate to treatment locations within blood vessels of interest (e.g., in the coronary anatomy).

[0005] In the examples described herein, a medical device system includes a catheter system (e.g., a balloon catheter system). The catheter system includes an elongated body and an expandable structure (e.g., a balloon) at a distal portion of the elongated body, and one or more sensor elements (e.g., strips or bands that include one or more individual sensors) carried by the expandable structure. In some examples, the expandable structure is configured to expand against a wall of a vessel and / or stent, e.g., to expand the stent against the vessel wall. The sensor elements may be physically and communicatively coupled to processing circuitry of the medical device system, and the processing circuitry can be configured to receive and process signals toPCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 determine one or more measures, indices, parameters related to the balloon, the blood vessel, or the stent, e.g., while the distal portion of the catheter system is inserted into the blood vessel of the patient. The measures, indices, parameters related to the balloon, the blood vessel, or the stent can include force values and / or pressure values based on forces and / or pressure applied by a stent or a blood vessel wall against the expandable structure (e.g., as measured by the sensor elements), as well as physiological information of the patient, including lesion morphology. In this way, a clinician may be enabled to receive indications of measures, indices, parameters related to the balloon, the blood vessel, or the stent and / or indications of the physiological information with the same device the clinician would use to expand the blood vessel and / or delivery and / or expand the stent.

[0006] In some examples described herein, the sensor elements are positioned and / or oriented in a way to increase the granularity, accuracy, and / or precision of measurements determined by use of the sensor elements. In some examples, the sensor elements overlap with each other to form a mesh and / or network of sensor elements. By forming a mesh of overlapping sensor elements, the system may be able to determine (e.g., identify and / or detect) relevant parameters (e.g., forces and / or pressures applied to the sensor elements and / or expandable structure, which can include a balloon) at a more granular and / or more accurate level as compared to systems that do not have a mesh or network of overlapping sensor elements.

[0007] In some examples described herein, the processing circuitry is configured to determine and / or generate, for output to a user (e.g., a clinician) relevant information of and / or relating to the forces and / or pressures that are measured by the sensor elements. In some examples, the processing circuitry is configured to determine a map of force values and / or pressure values (e.g., a map over a surface of the expandable structure and / or the stent). In some examples, the processing circuitry is configured to generate, for output (e.g., on a user interface), the map of force values and / or pressure values. In some examples, the processing circuitry is configured to determine and / or generate for output, one or more locations of malapposition of the stent against the blood vessel wall. In some examples, the processing circuitry is configured to determine and / or generate for output, one or more degrees of apposition of the stent against the blood vessel wall (e.g., adequately apposed, semi-adequately apposed, inadequately apposed, and / or malapposed). In some examples, the processing circuitry is configured to determine and / or generate for output, a shape (e.g., a geometry, including a cross-sectional shape at one or more locations) of the stent based on the one or more force values and / or pressure values.

[0008] Such information can enable a user (e.g., a clinician) target and / or selectively expand particular portions of the stent (e.g., a distal portion, a proximal portion, or the like) to improvePCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 the apposition of the stent against the blood vessel wall at such portions. In some examples, the processing circuitry is configured to determine and / or generate for output, a shape (e.g., a geometry, including a cross-sectional shape at one or more locations) of a blood vessel (e.g., including a geometry and / or shape of a lesion) based on the one or more force values and / or pressure values. Such information can enable a user (e.g., a clinician) determine whether clinical intervention is needed (e.g., whether to compress the lesion, which can include plaque, via an angioplasty or stenting procedure). Such information can enable a user (e.g., a clinician) to select an appropriate stent (e.g., e.g., a sizing, including length and diameter of one or more stent), and / or make another clinically relevant decision.

[0009] In some examples described herein, the processing circuitry is configured to determine (e.g., identify) one or more stent crimp zones. In some examples, stent crimp zones are characterized by strips of relatively lower pressure that the stent applies along the expandable structure as compared to positions circumferentially adjacent to the strips of relatively lower pressure. In some examples, the processing circuitry is configured to generate, for output (e.g., such as on a user interface) an indication and / or representation of the stent crimp zone. Such indications and / or representation can enable the user (e.g., a clinician) to differentiate stent crimp zones from other areas of relatively high and / or low pressure and / or force, which can enable the user to make clinically relevant decision based on the indications of the stent crimp zones.

[0010] Because a user (e.g., a clinician) may choose to ignore stent crimp zones when deciding whether or not further intervention is necessary (e.g., whether or not to further expand the stent), providing an indication of stent crimp zones along with the map of force values and / or pressure values can facilitate a relatively more accurate representation of forces that represent different degrees of apposition of the stent (e.g., as compared to systems that cannot identify and / or differentiate stent crimp zones from other areas of relatively higher and / or lower pressures not associated with stent crimp zones).

[0011] In some examples, a medical device system includes an elongated body configured to be inserted into a blood vessel of a patient; an expandable structure at a distal portion of the elongated body; a plurality of sensor elements carried by the expandable structure that form a mesh of sensor elements; and processing circuitry configured to: receive, via the plurality of sensor elements, one or more signals that indicate one or more pressures applied by a stent against the expandable structure, determine, based on the one or more signals, a map of pressure values applied by the stent against the expandable structure, determine a stent crimp zone by at least detecting an area of uniform pressure along the expandable structure, and generate, forPCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 output, an indication of the map of pressure values including a distribution of pressure values over the mesh of sensor elements and an indication of the stent crimp zone.

[0012] In some examples, a method includes receiving, by processing circuitry, one or more signals from a plurality of sensor elements carried by an expandable structure, the expandable structure at a distal portion of an elongated body configured to be inserted into a blood vessel of a patient; and determining, by the processing circuitry and based on the one or more signals, one or more of: an indication of a morphology of a lesion of the blood vessel, or a map of pressure values based on one or more pressures applied by a stent or a blood vessel wall against the expandable structure, wherein the plurality of sensor elements includes at least a first subset of sensor elements axially spaced apart along the expandable structure and a second subset of sensor elements circumferentially spaced apart around the elongated body, and wherein each sensor element of the first subset of sensor elements extends around an outer perimeter of the expandable structure and each sensor element of the second subset of sensor elements extends axially along the outer perimeter of the expandable structure such that the first subset of sensor elements and the second subset of sensor elements form a mesh of sensor elements.

[0013] In some examples, a medical device system includes an elongated body configured to be inserted into a blood vessel of a patient; an expandable structure at a distal portion of the elongated body; a plurality of sensor elements carried by the expandable structure that form a mesh of sensor elements; and processing circuitry configured to: receive, via the plurality of sensor elements, one or more signals that indicate one or more pressures applied by a stent against the expandable structure, determine, based on the one or more signals, a map of pressure values applied by the stent against the expandable structure, determine a stent crimp zone by at least detecting an area of uniform pressure along the expandable structure, and generate, for output, an indication of the map of pressure values including a distribution of pressure values over the mesh of sensor elements and an indication of the stent crimp zone.

[0014] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.BRIEF DESCRIPTION OF DRAWINGS

[0015] FIG. 1 A is a schematic illustration of an example medical device system including a catheter system.PCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001

[0016] FIG. IB is a schematic illustration of an example distal portion of the catheter system of FIG. 1 A including a balloon with sensor elements.

[0017] FIG. 1C is a schematic illustration including a cross-sectional view of the example distal portion of the catheter of FIG. IB.

[0018] FIG. 2 is a functional block diagram illustrating some components of the catheter system of FIG. 1A.

[0019] FIG. 3A is a schematic illustration of the catheter system of FIG. 1 A in a blood vessel and being used in conjunction with a stent.

[0020] FIG. 3B is a schematic illustration of an example user interface displaying information related to the catheter system.

[0021] FIG. 3C is a schematic illustration of an example user interface displaying information related to the catheter system.

[0022] FIG. 4 is a flow diagram illustrating an example technique for determining an indication of morphology of a blood vessel or a pressure mapping using a medical device system according to this disclosure.

[0023] Like reference characters denote like elements throughout the description and figures.DETAILED DESCRIPTION

[0024] This disclosure describes devices, systems, and methods relating to medical device systems, including catheter systems used during percutaneous coronary intervention (PCI) procedures. An example PCI procedure includes balloon angioplasty and / or stent placement in a hollow anatomical body (e.g., a blood vessel). Angioplasty balloons and / or stents are configured to expand radially outward at a treatment location, such as to open up a narrowed portion of a blood vessel, which may include an abnormal narrowing or blockage of the blood vessel. During an angioplasty or stent placement procedure, a clinician may insert a first balloon catheter into a blood vessel and inflate the balloon to open up a blood vessel prior to placement of a stent (e.g., as may be referred to herein as pre-dilation procedure). The clinician may then deliver the stent on a second balloon catheter to the treatment location and expand the stent to further open the narrowed portion of the blood vessel. After placement and expansion of the stent the clinician may further expand the stent or ensure uniform expansion with a third catheter (e.g., as may be referred to herein as post-dilation procedure).

[0025] In some examples, clinicians may use feedback from various imaging and / or measurement modalities to determine whether a stent has been sufficiently expanded, or whether further expansion is warranted. For example, clinicians may receive feedback from imagingPCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 modalities or other measurement tools to determine whether a stent has been sufficiently expanded, such after initial delivery and initial expansion and / or after a post-dilation expansion performed with a different catheter. Information about stent deployment and / or expansion may correlate with potential complications, including stent migration, dissection, and longer-term complications such as late stent thrombosis, in-stent restenosis, etc. In some cases, where a clinician receives feedback that a stent has not been adequately expanded and / or a stent is not adequately apposed against a blood vessel wall, a clinician may decide to further expand a stent, such to increase the clinical efficacy of the stent.

[0026] While the imaging and / or measurement systems used separately from the dilation and stent delivery catheters may be useful for assessing or confirming clinically relevant information related to stent delivery and stent placement, these separate systems may lead to extra procedure time, cost, and potential for complications, e.g., because these systems are separate (e.g., physically and communicatively) from the dilation and stent delivery catheters. For example, after a post-dilation expansion of the stent, a clinician may need to remove the post-dilation catheter from the patient in order to insert a separate catheter or medical device system configured for imaging and / or measurement. Examples of such separate and independent systems include intravascular ultrasound (IVUS) or optical coherence tomography (OCT) systems. Additionally, other non-invasive methods of confirming vessel opening (e.g., angiography) may not be accurate and / or precise enough to measure and / or confirm relevant measures of clinical effectiveness, including the degree of stent expansion or the degree of stent apposition.

[0027] In examples described herein, the catheters (e.g., balloon catheters) are configured for expansion against a vessel wall and / or against a stent to open up the vessel and / or expand the stent, as well as determine one or more clinically relevant parameters, measurements, or indices related to stent expansion (e.g., pressures and / or forces applied to and / or by the balloon against a stent and / or a vessel wall, as well as information about a blood vessel, including lesion morphology). In other words, the devices described herein may be configured to perform one or more of pre-dilation, stent delivery, stent expansion, and / or post-dilation stent expansion. Using such a multi-functional system may reduce procedure time and risk for complications by reducing the number of catheters that need to be inserted and removed from the patient. For example, the need for IVUS or OCT systems may be reduced or eliminated, as the catheter systems described in this disclosure may be configured to determine or confirm the parameters and / or measurements that IVUS or OCT systems would normally generate. Particularly in emergency cases where time is limited, using the multi-functional devices described herein may lead to improved patient outcomes, e.g., by sufficiently restoring blood flow to a sufficient levelPCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 in less time as compared to when separate systems are used. It should be understood that it may still be possible to use IVUS or OCT in addition to the techniques described in this disclosure. For example, in some examples, the medical devices systems described herein are configured to co-register with one or more separate imaging modalities. Such separate imaging modalities can include IVUS, OCT, angiography, computed tomography (CT), and / or magnetic resonance imaging (MRI).

[0028] Additionally, the systems may be configured to be a “smart” feedback system, such that balloon and / or stent expansion is automatically driven based on measurements (e.g., force values, pressure values, morphologies, etc.) of the system. Such “smart” systems may reduce or eliminate the need for clinician input, which may reduce time and the potential for human error while increasing safety for patients. For example, the systems described herein may provide (e.g., generate) recommendations to a clinician related to one or more medical procedures, such as angioplasty, stenting, assessment of lesion morphology, or related medical procedures.

[0029] In the examples described herein, a medical device system includes a catheter system (e.g., a balloon catheter system). The catheter system includes an elongated body and an expandable structure (e.g., a balloon) at a distal portion of the elongated body, and one or more sensor elements (e.g., strips or bands that include one or more individual sensors) carried by the expandable structure. In some examples, the expandable structure is configured to expand against a wall of a vessel and / or stent, e.g., to expand the stent against the vessel wall. The sensor elements may be physically and communicatively coupled to processing circuitry of the medical device system, and the processing circuitry can be configured to receive and process signals to determine one or more measures, indices, parameters related to the balloon, the blood vessel, or the stent, e.g., while the distal portion of the catheter system is inserted into the blood vessel of the patient. The measures, indices, parameters related to the balloon, the blood vessel, or the stent can include force values and / or pressure values based on forces and / or pressure applied by a stent or a blood vessel wall against the expandable structure (e.g., as measured by the sensor elements), as well as physiological information of the patient, including lesion morphology. In this way, a clinician may be enabled to receive indications of measures, indices, parameters related to the balloon, the blood vessel, or the stent and / or indications of the physiological information with the same device the clinician would use to expand the blood vessel and / or delivery and / or expand the stent.

[0030] In some examples described herein, the sensor elements are positioned and / or oriented in a way to increase the granularity, accuracy, and / or precision of measurements determined by use of the sensor elements. In some examples, the sensor elements overlap with each other toPCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 form a mesh and / or network of sensor elements. By forming a mesh of overlapping sensor elements, the system may be able to determine (e.g., identify and / or detect) relevant parameters (e.g., forces and / or pressures applied to the sensor elements and / or expandable structure, which can include a balloon) at a more granular and / or more accurate level as compared to systems that do not have a mesh or network of overlapping sensor elements.

[0031] In some examples described herein, the processing circuitry is configured to determine and / or generate, for output to a user (e.g., a clinician) relevant information of and / or relating to the forces and / or pressures that are measured by the sensor elements. In some examples, the processing circuitry is configured to determine a map of force values and / or pressure values (e.g., a map over a surface of the expandable structure and / or the stent). In some examples, the processing circuitry is configured to generate, for output (e.g., on a user interface), the map of force values and / or pressure values. In some examples, the processing circuitry is configured to determine and / or generate for output, one or more locations of malapposition of the stent against the blood vessel wall. In some examples, the processing circuitry is configured to determine and / or generate for output, one or more degrees of apposition of the stent against the blood vessel wall (e.g., adequately apposed, semi-adequately apposed, inadequately apposed, and / or malapposed). In some examples, the processing circuitry is configured to determine and / or generate for output, a shape (e.g., a geometry, including a cross-sectional shape at one or more locations) of the stent based on the one or more force values and / or pressure values.

[0032] Such information can enable a user (e.g., a clinician) target and / or selectively expand particular portions of the stent (e.g., a distal portion, a proximal portion, or the like) to improve the apposition of the stent against the blood vessel wall at such portions. In some examples, the processing circuitry is configured to determine and / or generate for output, a shape (e.g., a geometry, including a cross-sectional shape at one or more locations) of a blood vessel (e.g., including a geometry and / or shape of a lesion) based on the one or more force values and / or pressure values. Such information can enable a user (e.g., a clinician) determine whether clinical intervention is needed (e.g., whether to compress the lesion, which can include plaque, via an angioplasty or stenting procedure). Such information can enable a user (e.g., a clinician) to select an appropriate stent (e.g., e.g., a sizing, including length and diameter of one or more stent), and / or make another clinically relevant decision.

[0033] In some examples described herein, the processing circuitry is configured to determine (e.g., identify) one or more stent crimp zones. In some examples, stent crimp zones are characterized by strips of relatively lower pressure that the stent applies along the expandable structure as compared to positions circumferentially adjacent to the strips of relatively lowerPCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 pressure. In some examples, the processing circuitry is configured to generate, for output (e.g., such as on a user interface) an indication and / or representation of the stent crimp zone. Such indications and / or representation can enable the user (e.g., a clinician) to differentiate stent crimp zones from other areas of relatively high and / or low pressure and / or force, which can enable the user to make clinically relevant decision based on the indications of the stent crimp zones.

[0034] Because a user (e.g., a clinician) may choose to ignore stent crimp zones when deciding whether or not further intervention is necessary (e.g., whether or not to further expand the stent), providing an indication of stent crimp zones along with the map of force values and / or pressure values can facilitate a relatively more accurate representation of forces that represent different degrees of apposition of the stent (e.g., as compared to systems that cannot identify and / or differentiate stent crimp zones from other areas of relatively higher and / or lower pressures not associated with stent crimp zones).

[0035] As described herein, lesion morphology can include classifications of lesions and / or plaque such as calcific, fatty, fibrous, or the like. Other morphological information of lesions may include one or more of plaque composition, concentricity or eccentricity, tortuosity, regularity or irregularity of contour, absence or presence of thrombus, ostial or non-ostial, etc.

[0036] Although the example techniques described herein are described in many instances with reference to blood vessels (for example, cardiac blood vessels) and stents, the example techniques also have application to other anatomical sites (e.g., other suitable hollow and / or tubular anatomical structures, including brain ventricles, gastrointestinal tract such as the esophagus and / or intestines, the urinary track and associated structures, etc.) and the devices and systems described herein can be configured (e.g., have suitable shape and dimensions) for such sites. For example, the catheter systems described in this disclosure may be configured to access and determine information about other blood vessels, such as the neurovasculature, peripheral vasculature, or other suitable vascular sites. In some examples, the catheter systems described in this disclosure can be used to access coronary structures (e.g., such as for structural heart applications).

[0037] As used herein, the terms “distal” and proximal” define a position or direction with respect to the treating clinician or clinician’s control device (e.g., a handle assembly). “Distal” or “distally” can refer to a position distant from or in a direction away from the clinician or clinician’s control device. “Proximal” and “proximally” can refer to a position near or in a direction toward the clinician or clinician's control device.

[0038] While this disclosure is primarily described in term of diameters of vessels, stents, expandable structures, and / or other bodies which are generally tubular structures havingPCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 generally circular cross-sections, other related and / or derivative measures (including radii, area, volume, surface area, maximum dimension, minimum dimension, etc.) may be understood to be interchangeable where a diameter is determined, evaluated, or otherwise referenced.

[0039] FIG. 1 A, FIG. IB, and FIG. 1C illustrate a medical device system 100 and various components thereof. FIG. 1 A is a partially schematic perspective view illustrating a medical device system 100 configured in accordance with examples of the present disclosure. As illustrated in the example of FIG. 1A, medical device system 100 includes a catheter system 108. Catheter system 108 includes an elongated body 110 configured to be inserted into a blood vessel 102 of patient 106 (e.g., by a clinician) and positioned within blood vessel 102. Catheter system 108 includes one or more expandable structures (e.g., at a distal portion of catheter system 108), such as a balloon 112. FIG. IB illustrates a detail view of a distal portion of catheter system 108 including balloon 112 of FIG. 1 A. FIG. 1C illustrates a cross-sectional view of balloon 112, the cross section taken through the A-A section lines in the example of FIG. IB. While the term “catheter system” is used to throughout this disclosure with reference to catheter system 108, in other examples, catheter system 108 can additionally or alternatively be referred to as catheter 108.

[0040] Balloon 112 can have any suitable configuration. In some examples, balloon 112 is configured to expand (e.g., by inflation) when elongated body 110 is positioned within blood vessel 102 of patient 106. Balloon 112 may be configured to expand, for example, to be inflated and expand a stent 160 (e.g., as shown in FIG. IB) against a wall 104 of the blood vessel 102 (e.g., either as a stent-delivery balloon or a post-dilation balloon). In some examples, balloon 112 is configured to expand and exert a sufficient force on stent 160 to cause stent 160 to expand into apposition with vessel wall 104. In some examples, balloon 112 is configured to expand within blood vessel 102 against vessel wall 104, such as during a pre-dilation procedure to open blood vessel 102 or compress plaque before placement and / or expansion of stent 160. Elongated body 110 defines a central longitudinal axis 111 extending through a distal end 158 of elongated body 110. Balloon 112 may be configured to expand radially outwards relative to central longitudinal axis 111 (e.g., substantially perpendicular to central longitudinal axis 111) when balloon 112 is inflated within blood vessel 102 of patient 106.

[0041] Balloon 112 can include any suitable material or combination of materials. Balloon 112 may be constructed of any compliant, semi-compliant or non-compliant material, typically a plastic such as polyurethane, nylon, polyethylene, PET or PEB AX. In some examples, balloon 112 (e.g., the body of balloon 112) includes silicone. In some examples, balloon 112 is a dipped balloon fabricated using a dip molding process. In some examples, balloon 112 is expanded suchPCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 that an exterior surface of balloon 112 contacts vessel wall 104 and / or a stent. The strength of the wall of balloon 112 may be configured (e.g., have sufficient strength) to expand against vessel wall 104 and / or a stent, such as to further open blood vessel 102 and / or the stent.

[0042] In some examples, balloon 112 is configured to expand to a range of dimensions (e.g., diameters). For example, balloon 112 can be a compliant balloon and configured to expand to define a particular dimension within the range based on an inflation pressure within the balloon. In examples, the expanded dimension of balloon 112 is selected by a clinician based on a size of blood vessel 102, e.g., selected to enable balloon 112 to contact vessel wall 104 of blood vessel 102. In examples where balloon 112 is a compliant balloon, balloon 112 may be configured to exhibit a radial growth of about 10 percent or greater over a working range of pressures.

[0043] In some examples, balloon 112 is configured to expand to a fixed or relatively fixed dimension (within a tolerance) over a range of pressures. For example, balloon 112 can be a non- compliant balloon and configured exhibit less expansion over a working range of pressures such as to define a particular dimension regardless of what inflation pressure is selected by a clinician. As long as a minimum pressure is supplied to balloon 112, balloon 112 may be configured to expand to define the particular dimension, and remain at the particular dimension with slight or no expansion as pressure is further increased in balloon 112. In examples where balloon 112 is a non-compliant balloon, balloon 112 may be configured to exhibit a radial growth of about 4 to 6 percent over a working range of pressures.

[0044] In some examples, balloon 112 is configured to exhibit growth rates between that of a compliant balloon and a non-compliant balloon. For example, balloon 112 can be a semi- compliant balloon and configured to exhibit a growth of about 8 to 10 percent over a working range of pressures.

[0045] In examples, balloon 112 is configured such that an imaging system (e.g., an imaging system extracorporeal to patient 106) can capture an image of balloon 112 when balloon 112 is within patient 106. In some examples, elongated body 110 and / or balloon 112 includes one or more radiopaque markers for visualization via a suitable medical imaging technique.

[0046] In some examples, as shown in the example of FIG. IB, catheter system 108 includes a stent 160. In some examples, stent 160 defines a body portion extending between a stent body proximal end 161 A and a stent body distal end 161B. Stent 160 can include a plurality of interconnected struts 162. While the example of FIG. IB only illustrates cross-sectional views of particular struts 162, stent 160 can include interconnected struts 162 that generally form a tubular body of stent 160. In some examples, stent 160 defines a lumen such that stent can be positioned over balloon 112.PCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001

[0047] As illustrated in each of FIG. 1 A, FIG. IB, and FIG. 1C, catheter system 108 includes a plurality of sensor elements 114. FIG. IB illustrates a sensor element 114A, a sensor element 114B, a sensor element 114C, a sensor element 114D, a sensor element 114E, a sensor element 114F, a sensor element 114G, a sensor element 114H, a sensor element 1141, and a sensor element 114 J, which are shown in individually by collectively referred to herein as sensor elements 114. In some examples, each sensor element of sensor elements 114 include one or more piezoresistive sensors (e.g., that include one or more piezoresistive materials), and / or another type of resistive sensor configured to measure force and / or pressure. In some examples, the one or more piezoresistive sensors of each of sensor elements 114 are configured to generate an electrical signal, which can change based on an amount of force and / or pressure applied to the one or more piezoresistive sensors. In some examples, a voltage level of the electrical signal that is output by the one or more piezoresistive sensors changes based on the level (e.g., amount) of applied force and / or pressure to the one or more piezoresistive sensors. In some examples, sensor elements 114 are carried by (e.g., disposed on, embedded in, mechanically coupled to, or the like) balloon 112.

[0048] Device 130 can include suitable hardware and software configurations to enable device 130 to receive and / or process signals from sensor elements 114. In some examples, device 130 is configured to receive and / or process signals from sensor elements 114 for determination of pressure and / or force values, including determination of a map of force values and / or a map of pressure values (e.g., a one-dimensional and / or a multi-dimensional mapping of force values and / or mapping of pressure values) as discussed more fully herein. In some examples, sensor elements 114 forms a sensei matrix including an array or grid of individual sensor elements. In some examples, device 130 is configured to determine a location of one or more forces and / or pressures applied to sensor elements 114 (e.g., which can include a sensei matrix including an array or grid of individual sensor elements) by determining a frequency response of intersecting measurements (e.g., resistance measurements) across sensor elements 114. In some examples, device 130 performs a frequency scan to determine a location of force and / or pressure applied to sensor elements 114. By scanning the frequency response of intersecting measurements (e.g., resistance measurements) across a matrix of sensor elements 114, device 130 can determine a location of a force and / or a pressure applied to the matrix of sensor elements 114 (e.g., an axial and / or longitudinal location across a two-dimensional matrix of sensor elements 114).

[0049] As discussed herein, in some examples, device 130 (e.g., as illustrated in FIG. 1A) is configured to receive signals from sensor elements 114 such that device 130 can determine a level of force and / or pressure applied to sensor elements 114, and thus also the force and / orPCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 pressure applied to balloon 112. For example, sensor elements 114 can be configured to receive and relay signals indicative of one or more forces and / or pressures applied to sensor elements 114. In some examples, device 130 is configured to receive, from sensor elements 114, the signals (e.g., voltage signal) indicative of one or more forces and / or pressures and determine, based on the signals, a level of the force and / or pressure applied to sensor elements 114 (e.g., based on the level of the voltage signal). For example, device 130 can be configured to determine one or more force values and / or pressure values based on the signals indicative of force and / or pressure applied to sensor elements 114. Such force values and / or pressure values can be determined before, during, and / or after balloon 112 is expanded to press against stent 160 or blood vessel wall 104 of blood vessel 102. In this way, device 130 can be configured to determine one or more force values and / or pressure values based on forces and / or pressures applied by stent 160 and / or blood vessel wall 104 against balloon 112 and / or sensor elements 114.

[0050] In some examples, sensor elements 114 are carried balloon 112. For example, sensor elements 114 can be mechanically coupled to a surface (e.g., an external surface) of balloon 112 and / or be integrated into a wall of balloon 112. In some examples, as described further in connection with FIG. 1C, sensor elements 114 can be mechanically coupled to (e.g., disposed in) one or more layers (e.g., layers of material in which sensor elements 114 are embedded) disposed around balloon 112. For example, balloon 112 can include a layer of material that forms balloon 112, and one or more additional layers of material that include sensor elements 114 can be disposed around and mechanically coupled to the layer of material that forms balloon 112.

[0051] In some examples, sensor elements 114 includes multiple subsets of sensor elements 114 that are arranged and / or positioned in different orientations. In some examples, as shown in the example of FIG. IB, sensor elements 114 include a first subset of sensor elements 114 (e.g., including sensor element 114 A, sensor element 114B, sensor element 114C, sensor element 114D, sensor element 114E) axially spaced apart along balloon 112. In some examples, as illustrated in the example of FIG. IB, at least some (e.g., each) of the first subset of sensor elements 114 (e.g., including sensor element 114A, sensor element 114B, sensor element 114C, sensor element 114D, and sensor element 114E) extends around an outer of perimeter balloon 112 (e.g., such that each sensor element of the first subset of sensor elements 114 is perpendicular or substantially perpendicular to central longitudinal axis 111). In some examples, sensor elements 114 include a second subset of sensor elements 114 (e.g., including sensor element 114F, sensor element 114G, sensor element 114H, sensor element 1141, and sensor element 114 J) circumferentially spaced apart around the expandable structure. In some examples,PCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 as illustrated in the example of FIG. IB, at least some (e.g., each) of the second subset of sensor elements 114 (e.g., including sensor element 114F, sensor element 114G, sensor element 114H, sensor element 1141, and sensor element 114 J) extend axially along the outer perimeter of balloon 112 (e.g., such that each sensor element of the second subset of sensor elements 114 is parallel or substantially parallel to central longitudinal axis 111).

[0052] In other examples, first subset of sensor elements 114 (e.g., including sensor element 114A, sensor element 114B, sensor element 114C, sensor element 114D, and sensor element 114E) and second subset of sensor elements 114 (e.g., including sensor element 114F, sensor element 114G, sensor element 114H, sensor element 1141, and sensor element 114 J) have other arrangements relative to balloon 112. For example, in some examples, first subset of sensor elements 114 and second subset of sensor elements 114 are disposed at an angle (e.g., thirty degrees, forty-five degrees, sixty degrees, and / or the like) relative to central longitudinal axis 111 of balloon 112.

[0053] Sensor elements 114 may have any suitable configuration along and / or around balloon 112. In examples, as illustrated in FIG. IB, each sensor element of first subset of sensor elements 114 (e.g., including sensor element 114A, sensor element 114B, sensor element 114C, sensor element 114D and sensor element 114E) wraps circumferentially around balloon 112, e.g., such that each sensor element of first subset of sensor elements 114 at least partially wraps around balloon 112. In some examples, each sensor element of first subset of sensor elements 114 completely circumnavigates balloon 112. In examples, as illustrated in FIG. IB, each sensor element of second group of sensor elements 114 (e.g., including sensor element 114F, sensor element 114G, sensor element 114H, sensor element 1141, and sensor element 114 J) extends along balloon 112, e.g., such that each sensor elements of second group of sensor elements 114 extends at least a partial distance along balloon 112 between cone sections of balloon 112. In some examples, each sensor element of second group of sensor elements 114 extends completely between cone sections of balloon 112.

[0054] In some examples, sensor elements 114 form a mesh and / or network of sensor elements. Such an arrangement of sensor elements 114 can also be referred to as a grid of sensor elements 114 or a matrix of sensor elements 114. Sensor elements 114 can have any suitable configuration for forming a mesh and / or network of sensor elements 114. For example, as shown in the example of at least FIG. IB, sensor elements 114 of the first subset of sensor elements 114 (e.g., including sensor element 114A, sensor element 114B, sensor element 114C, sensor element 114D, and sensor element 114E) and sensor elements 114 from the second subset of sensor elements 114 (e.g., including sensor element 114F, sensor element 114G, sensor element 114H,PCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 sensor element 1141, and sensor element 114J) can at least partially overlap with each other (e.g., cross over each other) such that the first subset of sensor elements and the second subset of sensor elements form a mesh of overlapping sensor elements 114. By forming a mesh of overlapping sensor elements 114, system 100 may be able to determine (e.g., identify and / or detect) forces and / or pressures applied by stent 160 and / or blood vessel wall 104 to sensor elements 114 and / or balloon 112 at a more granular and / or more accurate level as compared to systems that do not have a mesh or network of overlapping sensor elements. For example, in some examples, device 130 is configured to determine a map of force values and / or a map of pressure values based on forces and / or pressures applied by stent 160 and / or blood vessel wall 104 against balloon 112 and / or sensor elements 114. Such determination of the map of force values and / or the map of pressure values may be possible (and / or useful to the extent that such maps can be used to make clinically relevant decisions), at least in part, because sensor elements 114 form a mesh and / or network of sensor elements.

[0055] As used herein, a “map” of values (e.g., in the context of a map of force values and / or map of pressure values) can be arranged in a one-dimensional, two-dimensional, and / or-three- dimensional configuration with individually plotted values and / or groups of values. As discussed in connection with FIG. 3B and FIG. 3C, a map of values can include multiple values that are grouped according to a certain range of values such that an output of the indication of the map includes a representation of values falling within respective groups. For example, groups of values can correspond to certain levels such as low, medium, and high. In some examples, groups of values (e.g., groups of force values and / or groups of pressure values) can also correspond to other clinically relevant measures and / or determinations, including a level apposition of stent 160 against vessel wall 104 of blood vessel 102. In some examples, because blood vessel 102, balloon 112 and / or stent 160 can generically have tubular and / or cylindrical shapes, a map of values can correspond to the values over a circumference of one or more of blood vessel 102, balloon 112 and / or stent 160 (e.g., which can be presented as a two-dimensional plane, if the circumference of blood vessel 102, balloon 112 and / or stent 160 were cut and laid flat).

[0056] Sensor elements 114 can have any suitable relative spacing between adjacent respective sensor elements 114. In some examples, as illustrated in FIG. IB, each of sensor elements 114 of the first subset of sensor elements 114 (e.g., including sensor element 114A, sensor element 114B, sensor element 114C, sensor element 114D, and sensor element 114E) carried by balloon 112 is separated by at least a longitudinal distance LI measured along central longitudinal axis 111 (e.g., such that at least some sensor elements 114 of the first subset of sensor elements 114 are longitudinally spaced apart from respective adjacent sensor elements 114PCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 along balloon 112). In the example of FIG. IB, all sensor elements of sensor elements 114 are equally spaced apart (e.g., are separated by longitudinal distance LI). However, in other examples, some or all of first subset of sensor elements 114 can have unequal spacing.

[0057] In some examples, as illustrated in FIG. IB, each of sensor elements 114 of the second subset of sensor elements 114 (e.g., including sensor element 114F, sensor element 114G, sensor element 114H, sensor element 1141, and sensor element 114J) carried by balloon 112 is separated by at least a circumferential distance L2 measured in a direction perpendicular to central longitudinal axis 111 and / or tangential to balloon 112 (e.g., such that at least some sensor elements 114 of the second subset of sensor elements 114 are circumferentially spaced apart from respective adjacent sensor elements 114 around balloon 112). In the example of FIG. IB, all sensor elements of second subset of sensor elements 114 are equally spaced apart (e.g., are separated by circumferential distance L2). However, in other examples, some or all of second subset of sensor elements 114 can have unequal spacing.

[0058] Longitudinal distance LI and circumferential distance L2 can be any suitable distance, e.g., for facilitate a suitable measurement density. In some examples, each of longitudinal distance LI and circumferential distance L2 are less than 1.0 mm. In some examples, each of longitudinal distance LI and circumferential distance L2 are 0.5 mm to 1.0 mm (e.g., about 0.64 mm or 0.64 mm). In some examples, longitudinal distance LI and circumferential distance L2 are less than an expanded cell size (e.g., a maximum internal dimension of a cell) of a stent that is being measured via sensor elements 114.

[0059] Although the example of FIG. IB illustrates catheter system 108 with ten sensor elements 114, catheter system 108 can include any suitable number of sensor elements 114 (e.g., one, two, three, four, five, six, seven, eight, nine, ten, twelve, fifteen, twenty, fifty, one-hundred, or more sensor elements 114, etc.). The number and / or spacing of sensor elements 114 may correspond to the granularity of measurements via sensor elements 114. For example, including sensor elements 114 spaced closer together (e.g., closer together along central longitudinal axis 111) may facilitate a more granular determination of diameters of balloon 112 along central longitudinal axis 111. Further, a number of sensor elements can depend on a size (e.g., length and / or diameter) of balloon 112. For example, a longer balloon can be configured to include more sensor elements along the length of the balloon as compared to a balloon with shorter length, e.g., to maintain a similar granularity of measurement between each of the two balloons.

[0060] Although the example of FIG. IB illustrates catheter system 108 as including sensor elements 114 in longitudinal and circumferential orientations that form right angles with respect to adjacent sensor elements 114, other suitable arrangement are possible. In some examples,PCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 sensor elements 114 are wrapped around balloon in a spiral (e.g., such that the mesh of overlapping sensor elements 114 form diamonds). In some examples, the mesh of overlapping sensor elements 114 overlap at non-orthogonal angles. In some examples, the mesh of overlapping sensor elements 114 mirrors a pattern of stent struts (e.g., of a stent being expanded by balloon 112). In some examples, sensor elements 114 are configuration (e.g., sized, shaped, positioned, and / or arranged) to follow struts of a stent.

[0061] Elongated body 110 can include any suitable configuration for supporting sensor elements 114 and / or balloon 112. In some examples, as shown the example of FIG. 1 A, elongated body 110 defines a distal portion 110A (“distal body portion 110A”) and a proximal portion HOB (“proximal body portion HOB”). Plurality of sensor elements 114 and / or balloon 112 are positioned on and / or carried by distal portion 110A in the example shown in FIG. 1 A. In some examples, catheter system 108 is configured to assume a relatively low-profile delivery configuration in which at least one of distal portion 110A and / or balloon 112 defines a fist dimension (e.g., a diameter), which can be measured in a direction perpendicular to central longitudinal axis 111. The first dimension may define a dimension sufficient to allow the passage of at least distal body portion 110A and balloon 112 through vasculature of patient 106 to reach a target treatment location within patient 106. In some examples, elongated body 110 define a lumen 113 for receiving the guidewire for delivery of elongated body 110 (e.g., at least distal body portion 110A) using a suitable technique, e.g., either an over the wire (OTW) technique or a rapid exchange (RX) technique.

[0062] In some examples, balloon 112 may be delivered with a guide device, such as guide sheath (not shown in the examples of FIG. 1 A or FIG. IB), with or without a using guidewire. In examples in which catheter system 108 includes a guide sheath, when balloon 112 is at the target treatment location, the guide sheath may be at least partially withdrawn or retracted or balloon 112 is advanced beyond the distal end of the guide sheath so that balloon 112 may be transformed into an expanded configuration. In other examples, elongated body 110 may be steerable itself such that balloon 112 and / or sensor elements 114 may be delivered to the treatment location without the aid of a guidewire and / or a guide sheath.

[0063] In some examples, distal body portion 110A is configured to locate sensor elements 114 at an intraluminal (e.g., intravascular) location. Intraluminal (e.g., intravascular) locations can include blood vessels with diameters on the order of millimeters, such as about 1 mm to 8 mm. In some examples, target locations include one or more coronary arteries, such as the left main coronary artery (LMCA), left anterior descending artery (LAD), and / or circumflex artery (CX), and Right Coronary Artery (RCA), and their respective side branches. However, otherPCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 blood vessels of smaller or larger sizes are contemplated (e.g., cranial blood vessels, peripheral blood vessels, etc.). Balloon 112 is configured to expand from the delivery configuration to an expanded configuration (e.g., FIG. IB) to, for example, position and / or stabilize distal body portion 110A and / sensor elements 114 when distal body portion 110A locates sensor elements 114 at the target treatment location.

[0064] In some examples, system 100 includes a device 130 configured to control, monitor, supply, and / or otherwise support operation of system 100 (e.g., including catheter system 108). In some examples, device 130 includes one or more of a processing device, power generation device, which may include any suitable configuration of inputs, outputs, displays, power supplies, and / or combinations of hardware and software for functioning of system 100. While device 130 is described in connection with catheter system 108, device 130 may be configured in other ways, such for use with multiple catheters and / or other medical systems, including other medical imaging systems such as IVUS and OCT systems.

[0065] In some examples, device 130 may include (or be coupled to) a user interface 132 configured to receive input from a user and / or output information to a user. For example, user interface 132 can include a button or keypad, a touch screen, a speaker configured to receive and / or output audible information, and / or a display, such as a liquid crystal (LCD), light-emitting diode (LED), or organic light-emitting diode (OLED). In some examples, user interface 132 is configured to output (e.g., present or display) information, such as one or more an indication of one or more force values and / or pressure values sensed by sensor elements 114 of balloon 112. In some examples, user interface 132 is configured to output a graphical representation (e.g., an image, picture, schematic representation, etc.) of blood vessel 102, other anatomical structures (e.g., a lesion, plaque, a blood vessel wall, and / or the like), stent 160, and / or balloon 112. In some examples, user interface 132 is configured to output the graphical representation of blood vessel 102, other anatomical structures (e.g., a lesion, plaque, a blood vessel wall, and / or the like), stent 160, and / or balloon 112 including one or more determined values (e.g., one or more force values and / or pressure values, including a map of force values and / or a map of pressure values). The graphical representation can include one or more colors, legends, and / or other keys.

[0066] In some examples, device 130 is configured to control, monitor, supply, and / or otherwise support operation of catheter system 108. For example, device 130 can be configured to generate a selected form and / or magnitude of energy (e.g., current) to sensor elements 114. For example, device 130 can include a generator configured to generate energy (e.g., pulsed field, electrical current, microwave, radiofrequency, monopolar, and / or bipolar energy). In other examples, device 130 may be another type of device configured to generate and deliver anotherPCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 suitable type of energy to catheter system 108. In some examples, device 130 is configured to receive one or more resulting signals from sensor elements 114 based on the signals applied to sensor elements 114. For example, device 130 can be configured to receive a resulting voltage signal from sensor elements 114, e.g., for determination of one or more of a pressure and force applied to sensor elements 114 and / or balloon 112. As discussed in relation to later examples, device 130 can be configured to determine a map of force values and / or map of pressure values over the mesh of overlapping sensor elements 114.

[0067] In examples where balloon 112 is expanded against a stent (e.g., stent 160 as shown in the examples of FIG. IB and FIG. 1C), device 130 can configured to determine one or more locations of stent malapposition (e.g., against vessel wall 104 of blood vessel 102), one or more degrees of apposition of stent 160 against vessel wall 104, as well as other measures and indices related to the expansion of stent 160 and the apposition of stent 160 against vessel wall 104 of blood vessel 102.

[0068] In some examples, as shown in the example of FIG. IB, catheter system 108 includes a plurality of conductor wires 152. Conductor wires may be physically and / or communicatively coupled to each of sensor elements 114 and device 130, such that electrical signals may be transmitted between sensor elements 114 and device 130. Sensor elements 114 and device 130 may additionally or alternatively be communicatively coupled in other ways, including via printed circuits, or other suitable techniques, including, but not limited to, intermediate microelectronics, micro-electromechanical system (MEMS) devices, and the like. In other examples, sensor elements 114 and device 130 are configured to communicate wireless and / or at least partially wirelessly.

[0069] Medical device system 100 includes a cable 147 configured to deliver power and / or facilitate communication between device 130 and catheter system 108. Along cable 147 or at another suitable location within medical device system 100, medical device system 100 may include a control device 145 configured to initiate, terminate, and / or adjust operation of one or more components of catheter system 108 directly and / or via device 130. In some examples, device 130 is configured to execute an automated control algorithm and / or to receive control instructions from an operator. Similarly, in some implementations, device 130 is configured to provide feedback to an operator before, during, and / or after a treatment procedure via an evaluation / feedback algorithm.

[0070] In some examples, medical device system 100 includes a handle portion 150 coupled to proximal body portion HOB, which is configured to remain outside vasculature of patient 106 when distal body portion 110A is within vasculature of patient 106. Handle portion 150 may bePCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 configured to allow a clinician to navigate at least distal body portion 110A through the vasculature, allow inflation and / or deflation of balloon 112, and / or enable other functions of medical device system 100 which may assist in the delivery of a treatment to patient 106. At least some portion of catheter system 108 (e.g., distal body portion 110A) may be substantially flexible, such that catheter system 108 may flex and / or bend enroute to positioning balloon 112 and / or sensor elements 114 within blood vessel 102 of patient 106. Hence, although illustrated as substantially linear in FIG. 1 A, catheter system 108 (or portions thereof) may be configured to assume linear, curved, and / or curvilinear shapes. Correspondingly, central longitudinal axis 111 (and / or portions thereof) defined by catheter system 108 may be linear, curved, and / or curvilinear.

[0071] In examples, catheter system 108 is configured to inflate and / or expand balloon 112 with a fluid (e.g., liquid) such as water, saline, contrast, conductive fluid, another suitable liquid, or a combination thereof. In some examples, balloon 112 defines an interior volume 116, e.g., such that balloon 112 is configured to be inflated by fluid (e.g., a liquid). In some examples, the fluid water or saline. In some examples, catheter system 108 is configured such that the fluid may flow into a fluid inlet 118, through an inlet lumen defined by elongated body 110, through interior volume 116, in order to inflate balloon 112. Inlet 118 may also serve as an outlet, e.g., such as to remove fluid and deflate balloon 112. In some examples, device 130 is configured to inflate balloon 112, e.g., through controlled delivery of a fluid. However, in other examples, a separate automated device (e.g., pump) or manual device (e.g., hand-held syringe or other manual balloon catheter inflation device) inflates balloon 112.

[0072] FIG. 1C illustrates a cross-sectional view of balloon 112 of catheter system 108, the cross section taken through the A-A section lines in the example of FIG. IB. As shown in the example of FIG. 1C, catheter system 108 can include one or more layers disposed around balloon 112 in which sensor elements 114 are caried. In some examples, as shown in the example of FIG. 1C, balloon 112 includes at least a first layer 115A and a second layer 115B surrounding first layer 115A. Sensor elements 114 can be disposed in (e.g., embedded in), mechanically affixed to, and / or otherwise defined by one of more of first layer 115A and second layer 115B.

[0073] First layer 115A and second layer 115B can have any suitable configuration for carrying and / or defining sensor elements 114. In some examples, each of first layer 115A and second layer 115B include a film (e.g., a polymer film). In some examples, respective subsets of sensors elements 114 are embedded in each of first layer 115A and second layer 115B. Each of each of first layer 115A and second layer 115B can include a suitable thickness, which can enable catheter system 108 including balloon 112 to maintain a relatively low-profile and / orPCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 facilitate deliverability. In some examples, each of first layer 115A and second layer 115B defines a thickness of less than 1 mm. In some examples, each of first layer 115A and second layer 115B defines a thickness of less than 0.5 mm. In some examples, each of first layer 115A and second layer 115B defines a thickness of less than 0.2 mm (e.g., less than 0.1 mm).

[0074] First layer 115A and second layer 115B can be mechanically affixed to and / or integrated with balloon 112 in any suitable manner. In some examples, each of first layer 115A and second layer 115B and / or sensor elements 114 are bonded to balloon 112. In some examples, each of first layer 115A and second layer 115B and / or sensor elements 114 are crimped to balloon 112 (e.g., crimped to balloon 112 when balloon 112 is in a low-profile, deflated configuration). In some examples, each of first layer 115A and second layer 115B and / or sensor elements 114 are merged (e.g., mechanically coupled) with and / or to balloon 112 via a heat treatment process. In some examples, sensor elements 114 are directly merged to balloon 112 (e.g., without additional layers such as first layer 115A and / or second layer 115B). As discussed through this disclosure, balloon 112 can include one or more of a post-dilation balloon, a stent expansion balloon, and / or another type of balloon.

[0075] In some examples, as illustrated in FIG. 1C, the first subset of sensor elements 114 (e.g., including at least sensor element 114 A, sensor element 114B, sensor element 114C, sensor element 114D, sensor element 114E, with only sensor element 114C illustrated in the example of FIG. 1C) is disposed in and / or defined by first layer 115A. In some examples, as illustrated in FIG. 1C, the second subset of sensor elements 114 (e.g., including at least sensor element 114F, sensor element 114G, sensor element 114H, sensor element 1141, and sensor element 114 J) is disposed in and / or defined second layer 115B. By using multiple layers (e.g., at least first layer 115A and second layer 115B) with respective subsets of sensor elements 114, a relatively higher density of sensor elements 114 can be used with balloon 112 (e.g., as opposed to system that only use a single layer with one type and / or orientation of sensor elements). Additionally, using multiple layers (e.g., at least first layer 115A and second layer 115B) each having sensor elements 114 in different orientations can facilitate a relatively easier assembly and / or manufacturing process to create mesh and / or network of overlapping sensor elements 114.

[0076] In some examples, second layer 115B defines at least one channel 154. In some examples, channel 154 extends axially through at least a portion of first layer 115A. In some examples, channel 154 is configured to receive at least one of conductor wires 152. Channel 154 can enable electrical connection of device 130 to one or more sensor elements 114 via one or more conductor wires 152 (e.g., at least sensor element 114C as shown in FIG. 1C) while maintaining a relatively small form factor of catheter system 108 and / or balloon 112.PCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001

[0077] Although the example of FIG. 1C illustrates first layer 115A (e.g., that includes the first subset of sensor elements 114) as radially inside of second layer 115B (e.g., that includes second subset of sensor elements 114), such relative positioning of first layer 115A and second layer second layer 115B can be flipped. For example, first layer 115A (e.g., that includes the first subset of sensor elements 114) can be radially outside of second layer 115B (e.g., that includes second subset of sensor elements 114).

[0078] Although the example of FIG. 1C illustrates catheter system 108 as having two layers (e.g. first layer 115A and second layer 115B) radially outside of balloon 112, catheter system 108 (including balloon 112) can include more or less layers (e.g., more layers with and / or without more of sensor elements 114). For example, in some examples, catheter system 108 includes a third layer with a third subset of sensor elements 114 positioned radially outside of second layer 115B. The third subset of sensor elements 114 can have a different orientation relative to balloon 112 as compared to first subset of sensor elements 114 and second subset of sensor elements 114 described above. For example, the third subset of sensor elements can be disposed at an acute angle (e.g., forty-five degrees) relative to first subset of sensor elements 114 and second subset of sensor elements 114.

[0079] Although not shown in the examples of FIG. 1 A, FIG. IB, and / or FIG. 1C, system 100, including catheter system 108 can include one or more additional sensors and / or therapy elements. Additional sensors can include one or more electrodes, optical sensors, temperature sensors, ultrasound sensors and / or ultrasound transducers, accelerometers, flow sensors, etc., or a combination thereof. Therapy delivery elements can include one or more electrodes configured to transmit electrical stimulation therapy, ultrasound transducers configured to transmit ultrasound energy, and / or the like. For example, catheter system 108 can include one or more sensors and / or therapy deliver elements along elongated body 110, either within the area defined by balloon 112, as well as proximal to and / or distal to balloon 112 along elongated body 110.

[0080] FIG. 2 is a functional block diagram illustrating components of an example device 130, which is configured to receive and process signals related to catheter system 108, as well output information and control one or more operations related to catheter system 108. As described above, device 130 is configured to receive and process signals from the one or more sensor elements 114. Device 130 includes processing circuitry 30, memory 32, signal generation circuitry 34, sensing circuitry 36, telemetry circuitry 38, and power source 40. Although processing circuitry 30, signal generation circuitry 34, sensing circuitry 36, and telemetry circuitry 38 are described herein as separate components, one or more functionalities may be attributed generally to the processing capability of device 130. For example, functionalities ofPCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 signal generation circuitry 34, sensing circuitry 36, and telemetry circuitry 38 may herein be generally described as a functionality of processing circuitry 30. In some examples, device 130 includes user interface 132 (as described in connection with FIG. 1 A), as well as suitable hardware and / or software configuration generating and presenting information via user interface 132. Any of the functionalities of device 130 described in this disclosure can be attributed to processing circuitry 30, alone and / or in combination with any of memory 32, signal generation circuitry 34, sensing circuitry 36, telemetry circuitry 38, power source 40, and / or user interface 132.

[0081] Signal generation circuitry 34 includes any suitable configuration (e.g., hardware) configured to generate signals (e.g., electrical signals such as current or voltage, as other types of signals) to and / or between one or more sensor elements 114. Although primarily described in the context of electrical signals, signal generation circuitry 34 may be configured to deliver any suitable type of signal (e.g., ultrasound, etc.) for determining information about blood vessels and / or stents. Processing circuitry 30 is configured to control signal generation circuitry 34 to generate signals. Processing circuitry 30 may be configured to control signal generation circuitry 34 to generate signals according to a predefined program, which may define one or more of an amplitude, duration, pulse rate, or another suitable signal parameter. The generated signals may be of any suitable form, such as pulses or continuous-time signals (e.g., sine waves). When processing circuitry 30 (e.g., via signal generation circuitry 34) applies a current to sensor elements 114, sensor elements 114 may output a resulting voltage signal (e.g., which can change based on the amount of pressure and / or force applied to sensor elements 114). In this way, processing circuitry 30 is configured to apply an electrical signal (e.g., current signal and / or voltage signal) to sensor elements 114 to induce an output signal (e.g., voltage signals) in the sensor elements 114. In other examples, the resulting signal from sensor elements 114 may be one or more of the other signals described herein (e.g., a resulting current from an applied voltage).

[0082] Sensing circuitry 36 is configured to receive, via sensor elements 114, one or more signals for determination of information, including one or more forces and / or pressures applied by stent 160 or blood vessel wall 104 against balloon 112 including sensor elements 114. Sensing circuitry 36 may include any sensing hardware configured to receive signals from sensor elements 114, which may include a resulting voltage from sensor elements 114 based on the electrical signal applied to sensor elements 114 by signal generation circuitry 34. Processing circuitry 30 may receive, alone or in combination with sensing circuitry 36, the resulting signals from sensor elements 114. In some examples, processing circuitry 30 additionally receives one orPCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 more additional signals, including signals indicative of temperature, for determination of information, including morphology of a lesion of the blood vessel, and / or force and / or pressure values sensed by sensor elements 114 of balloon 112.

[0083] In some examples, processing circuitry 30, alone or in combination with the sensing circuitry 36, determines, based on the received signals from sensor elements 114, a map of pressure values and / or map of force values based on one or more pressures applied by stent 160 or blood vessel wall 104 against balloon 112 (as well as sensor elements 114). For example, in some examples, processing circuitry 30 is configured to receive resulting voltage values from sensor elements 114 and determine a map of pressure values by applying the resulting voltage values to an equation, a model, a lookup table, and / or another relational method to determine pressures and / or forces. In some examples, the equation, the model, and / or the lookup table relates voltage values (e.g., measured and / or recorded voltage values) from sensor elements 114 to pressure values and / or force values.

[0084] In some examples, processing circuity 30 is configured to generate the map of pressure values and / or map of force values using known locations of sensor elements 114 relative to balloon 112. In some examples, memory 32 stores the predetermined and / or known location of sensor elements 114 such that processing circuitry 30 can access such predetermined locations and generate the map of pressure values and / or map of force values, at least in part, with the predetermined and / or known location of sensor elements 114.

[0085] In some examples, the processing circuitry 30 is configured to determine and / or generate for output, a shape (e.g., a geometry, including a cross-sectional shape at one or more locations) of stent 160 based on the one or more force values and / or pressure values (e.g., including based on the map of pressure values and / or map of force values). For example, in some examples, processing circuitry 30 determines that stent 160 defines a circular shape (e.g., cross- sectional shape) at one or more locations (e.g., axial locations along balloon 112 and / or stent 160) based on a measured uniform or relatively uniform force and / or pressure around the circumference of balloon 112 (e.g., as measured by sensor elements 114). In some examples, processing circuitry 30 determines that stent 160 defines a non-circular shape (e.g., cross- sectional shape) at one or more locations (e.g., axial locations along balloon 112 and / or stent 160) based on a measured non-uniform force and / or pressure around the circumference of balloon 112 (e.g., as measured by sensor elements 114). In some examples, processing circuitry 30 generates for output (e.g., via user interface 132) indications of the determined shape (e.g., determined cross-sectional shape and / or geometry) of stent 160 (e.g., a two-dimensional or three- dimensional representation of a determined shape of stent 160). Such information can enable aPCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 clinician to target and / or selectively expand particular portions of stent 160 (e.g., a distal portion, a proximal portion, or the like) to improve the apposition of stent 160 in such portions of stent 160. By selectively expanding only portions of stent 160 to reach an adequate level of apposition, over-expansion of adequately apposed portions of stent 160 can be reduced and / or entirely avoided.

[0086] In examples where processing circuitry 30 is configured to apply voltage signal values to a model to determine forces and / or pressures, the model defines a relationship between the one or more voltage signal values and the one or more force values and / or pressures values. For example, the model may include a include a predefined equation relating the one or more voltage signal values and the force values and / or pressures values. For example, the model may use sensed information and / or user input information to determine force values and / or pressures values applied to sensor elements 114 (and thus also to balloon 112, which can be based on balloon expanding against vessel wall 104 and / or stent 160).

[0087] In some examples, where processing circuitry 30 is configured to apply received signals from sensor elements 114 to a model to determine a map of pressure values and / or map of force values, the model may include an artificial intelligence (Al) or machine learning (ML) model. Additionally or alternatively, processing circuitry 30 is configured to apply signals indicative of lesion morphology to an Al model or ML model to determine one or more measures of lesion morphology. In some examples, the Al model or ML model includes one or more of a statistical machine learning model, deep learning model (e.g., neural network), a physics informed neural network (e.g., that includes equations relating changes in pressure and / or force as measured by sensor elements 114 to dimensions of balloon 112, a stent, blood vessel 102 and / or dimensions or measures of other relevant structures). In some examples, the Al model or ML model is configured to output information (e.g., force and / or pressure values, as well as dimensions of balloon 112, a stent, blood vessel 102 and / or other relevant structures) based on one or more inputs (e.g., voltage signal values and / or other signals from sensor elements 114). In some examples, the Al model is trained (e.g., via supervised, semi-supervised, unsupervised, or reinforcement learning) on clinical data or other experimental data. For example, the Al model may be trained with data relating voltage signal values to force and / or pressure values, dimensions of balloon 112, a stent, blood vessel 102 and / or other relevant structures, and / or morphological data of lesions of vessels from previous procedures and / or experiments (e.g., data measured or verified with other measurement modalities, including IVUS and / or OCT). In some examples, the Al model or ML model is configured to output the force and / or pressure values, dimensions of balloon 112, a stent, blood vessel 102 and / or other relevant structures, and / orPCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 morphological data of one or more lesions of blood vessel 102. In some examples, the Al model or ML model is additionally configured to output a confidence score indicative of a confidence of the output. The confidence score may indicate an accuracy of the output.

[0088] In some examples, the model includes reference information (e.g., reference diameters) for use in determining additional information (e.g., degrees of stent expansion and stent apposition) based on the measured pressures and / or forces. Reference information, including diameters may include and / or be based on previous measurements of a blood vessel (e.g., before stent deployment), and / or a characterized (nominal) stent size. In some examples, an output of the model (e.g., resulting from the one or more voltage signal values applied to the model) includes the one or more dimensions (e.g., diameters) of balloon 112 and / or the blood vessel 102 and / or a stent.

[0089] In some examples, processing circuitry 30 determines, based on a determined diameter of the stent as expanded and the reference diameter of the stent, a degree of stent expansion. For example, a reference diameter for a particular stent may be nominal or desired diameter, such as 5 millimeters (mm), and the determined diameter can include the actual or estimated diameter of the stent (e.g., 3 mm, 5 mm, 7 mm, etc.). By comparing the reference diameter for the stent and the determined diameter, the degree of stent expansion can be expressed qualitatively (e.g., under-expanded, optimally expanded, over-expanded, etc.) and / or quantitatively. For example, for a particular stent with a reference diameter of 5 mm, a 3 mm determined expanded diameter may indicate under-expansion, a 5 mm (or nearly 5mm) determined expanded diameter may indicate optimal expansion, and a 7 mm determined expanded diameter may indicate over-expansion. As another example, the degree of stent expansion may be a percentage of the reference diameter of the stent (e.g., 30 percent, 40 percent, 50 percent, 60 percent, 70 percent, 80 percent, 90 percent, 100 percent, 110 percent, 120 percent etc.).

[0090] In some examples, processing circuitry 30 determines a minimum value, maximum value, average, mean, standard deviation, or another statistical measure from multiple determined values (e.g., pressure values and / or force values) or related values (e.g., values of the degree of stent expansion and / or values of the degree of stent apposition). For example, processing circuitry 30 may determine a minimum or maximum pressure and / or force applied to balloon 112. Such minimum or maximum pressures and / or forces, or other values, may be output to a user (e.g., a clinician) as described elsewhere in this disclosure.

[0091] Further examples of clinically relevant measures and indices which processing circuitry 30 may be configured to determine include one or more of a lesion length, dissection ofPCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 the lesion or blood vessel 102 (e.g., medial dissection), and / or other clinically relevant information. These other clinically relevant measures may be performed by expanding balloon 112 against the vessel wall 104 of blood vessel 102, such as before stent placement.

[0092] In some examples, processing circuitry 30, alone or in combination with the sensing circuitry 36, determines an indication of a morphology of a lesion of blood vessel 102 based on received signals from sensor elements 114 (e.g., signals that indicate one or more force and / or pressure values). In some examples, a clinician expands balloon 112 against vessel wall 104 including a lesion such that reaction forces and / or pressures of the lesion are applied to the sensor elements 114. In some examples, processing circuitry 30 compares such reaction to a predetermined ranges of force and / or pressure values corresponding to lesions having particular morphological characteristics. For example, in some examples, processing circuitry 30 is configured to classify the lesion as a calcific lesion, a soft lesion (e.g., lipid based), a fatty lesion, a fibrous lesion, and / or another type of lesion based on signals that indicate one or more force values and / or pressure values. In some examples, relatively higher force values and / or pressure values determined by processing circuitry 30 correspond to harder and / or calcific lesions (e.g., which can indicate that the lesion is not deforming in response pressure applied by balloon 112). In some examples, relatively lower force and / or force values determined by processing circuitry 30 correspond to softer lesions (e.g., which can indicate that the lesion is deforming in response pressure applied by balloon 112). Other morphological information of lesions may include one or more of concentricity or eccentricity, tortuosity, regularity or irregularity of contour, absence or presence of thrombus, ostial or non-ostial, as well as other relevant measures and indices. Morphological information may be determined in accordance with The American College of Cardiology / American Heart Association (ACC / AHA) lesion morphology classification and / or the subsequent modified ACC / AHA classification.

[0093] Once processing circuitry 30 has determined one or more force values and / or pressure values (e.g., including a map of force values and / or pressure values) based on received signals from sensor elements 114, processing circuitry 30 may generate, for output, an indication of the force values and / or pressure values (e.g., including an indication of map of force values and / or pressure values). For example, in some examples, processing circuitry 30 is configured to generate, for output (e.g., via a display, such as user interface 132 of device 130) a numerical representation (e.g., a value) of the one or more force values and / or pressure values. In some examples, as discussed in connection with FIG. 3B and FIG. 3C processing circuitry is configured to generate, for output, an indication of the map of pressure values including an indication of a distribution of pressure values over the mesh of sensor elements 114. AdditionallyPCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 or alternatively, processing circuitry 30 may be configured to generate, for output, other determined values, as have been described herein, including the degree of stent expansion, the degree of stent apposition, and / or of the like. In examples in which device 130 determines a shape of stent 160, processing circuitry 30 may generate, for output, one or more indications of a shape (e.g., a cross-sectional shape) of stent 160. In examples in which device 130 determines morphology of a lesion of blood vessel 102, processing circuitry 30 may be configured to generate, for output, an indication of the morphology of blood vessel 102 (e.g., including an indication whether the lesion is a calcific lesion or a soft lesion).

[0094] In some examples, processing circuitry 30 is configured to output, e.g., via user interface 132, a graphical representation (e.g., an image, picture, schematic representation, etc.) of blood vessel 102, other anatomical structures (e.g., a lesion, plaque, a blood vessel wall, and / or the like), stent 160, and / or balloon 112. Further, in some examples, processing circuitry 30 is configured to overlay one or more determined values (e.g., force values, pressure values, maps of force values, maps of pressure values) with or over the graphical representation of blood vessel 102, other anatomical structures (e.g., a lesion, plaque, a blood vessel wall, and / or the like), stent 160, and / or balloon 112. For example, processing circuitry 30 may overlay force values, pressure values, and / or other indications of force values, pressure values over a portion of a graphical representation of blood vessel 102, stent 160, other anatomical structures (e.g., a lesion, plaque, a blood vessel wall, and / or the like), and / or balloon 112 that corresponds to the particular determined values (e.g., at the location of stent 160 where the particular force value and / or pressure value occurs). In some examples, as discussed further in relation to FIG. 3 A, FIG. 3B, and FIG. 3C, processing circuitry 30 is configured to generate (e.g., for output, e.g., via user interface 132), an indication (e.g., a graphical representation) of a map of pressure values including a distribution of pressure values over a representation of the mesh of sensor elements.

[0095] The indication of the one or more determined force values and / or pressure values applied by and / or against balloon 112 and / or the blood vessel 102 and / or stent 160 may enable a clinician to make a clinically relevant decision or confirm efficacy of a previous treatment. For example, the indication of the force values and / or pressure values (including a map of force values, map of pressure values, and / or the like) and / or other determined values are determined with instruments a clinician would already be using (e.g., a stent delivery catheter or post-dilation catheter), which may reduce and / or eliminate the need for other instruments (e.g., IVUS and OCT) and / or decrease procedure time. For example, a clinician may confirm an acceptable expansion and / or apposition of stent 160 against a vessel wall 104. As another example, a clinician may decide that further intervention is necessary based on a level of apposition of stentPCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001160 being below a particular threshold and / or an indication of an area of malapposition of stent 160. In cases where further intervention is necessary, a clinician may further expand stent 160 with the same balloon catheter (e.g., including stent 160) used to determine the force values and / or pressure values. In this way, the need for additional imaging and / or imaging systems for determining force values and / or pressure values is reduced and / or eliminated given the multifunctional catheter system 108 according to this disclosure.

[0096] While the need for additional imaging and / or imaging systems may be reduced and / or eliminated, in some examples, processing circuitry 30 is configured to co-register the map of force values, map of pressure values, and / or the like with a separate medical imaging modality. In some examples, the separate medical imaging modality includes one or more of angiography, computed tomography (CT), magnetic resonance imaging (MRI), CathWorks® model, and / or the like. For example, in some examples, processing circuitry 30 is configured to receive image data from the separate imaging modality and generate the map of force values, map of pressure values, and / or the like with the image data from the separate imaging modality. In some examples, processing circuitry 30 can overlay the map of force values and / or map of pressure values onto images from the separate imaging modality. Such co-registering can enable processing circuitry 30 to better correlate force values and / or pressure values with specific locations on balloon 112, stent 160 and / or blood vessel 102 (e.g., as compared to catheter systems with sensors that do not co-register measurements with a separate medical imaging modality).

[0097] In some examples, processing circuitry 30 is configured to generate, for output, one or more recommendations to a user (e.g., clinician) based on determined information (e.g., one or more force and / or pressure values, a map of force and / or pressure values, and / or other determined information). For example, in some examples, processing circuitry 30 is configured to generate for output (e.g., on user interface 132), one or more of a recommended position for catheter system 108, such as a position of balloon 112 in relation to blood vessel 102, a recommended inflation pressure or pressure change (e.g., increase or decrease) to balloon 112, a recommended amount to expand stent 160 (e.g., a recommended diameter to expand stent 160 to), and / or another clinically relevant recommendation. In some examples, such recommendations may facilitate a clinician’s decision to move catheter system 108 (including balloon 112) within blood vessel 102. In some examples, processing circuitry 30 is configured to output a recommendation to move stent 160 (e.g., to a new location within blood vessel 102 for further expansion) based on the determined information (e.g., one or more force and / or pressure values, a map of force and / or pressure values, and / or other determined information). In somePCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 examples, such recommendations may facilitate a clinician’s decision to further inflate and / or deflate balloon 112 (e.g., for further expansion of a stent or for further compressing balloon 112 against vessel wall 104). In some examples, such recommendation may facilitate a clinician’s decision to take other appropriate course of action, including (but not limited to), delivery of additional stents, introducing a drug into blood vessel 102, and / or introducing another medical device into blood vessel 102.

[0098] Although system 100 is primarily described in the context of manual inflation via fluid inlet 118, device 130 (including processing circuitry 30) may be able to control (e.g., automatically control) inflation of balloon 112. For example, device 130 (e.g., processing circuitry 30) may be configured to receive one or more inputs including one or more measured force and / or pressure values, a level of stent expansion and / or apposition (e.g., a desired or target level and / or degree of stent expansion and / or apposition), or another relevant value, and inflate (e.g., automatically inflate) balloon 112 based on the one or more inputs.

[0099] In some examples, sensing circuitry 36 is additionally or alternatively configured to sense a physiological parameter of a patient including temperature, pressures, sounds, light, infrared signals such as via one or more electrodes, sensors (e.g., optical receivers, pressure sensors) or the like. The one or more electrodes and / or sensors be the same or different from plurality of sensor elements 114 configured to receive signals via signal generation circuitry 34. Processing circuitry 30 can use the sensed physiological signals to further assess information about blood vessel 102 and / or the stent. For example, sensing circuitry 36 may receive signals indicative of temperature (e.g., via a temperature sensor within a blood vessel). In some examples, processing circuitry 30 uses temperature values for determination of morphological information.

[0100] In some examples, sensing circuitry 36 and / or processing circuitry 30 includes signal processing circuitry configured to perform any suitable analog conditioning of the sensed physiological signals. For example, sensing circuitry 36 may communicate to processing circuitry 30 an unaltered (e.g., raw) signal. Processing circuitry 30 may be configured to modify a raw signal to a usable signal by, for example, filtering (e.g., low pass, high pass, band pass, notch, or any other suitable filtering), amplifying, performing an operation on the received signal (e.g., taking a derivative, averaging), performing any other suitable signal conditioning (e.g., converting a current signal to a voltage signal), or any combination thereof. In some examples, the conditioned analog signals may be processed by an analog-to-digital converter of processing circuitry 30 or other component to convert the conditioned analog signals into digital signals. In some examples, processing circuitry 30 may operate on the analog or digital form of the signalsPCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 to separate out different components of the signals. In some examples, sensing circuitry 36 and / or processing circuitry 30 may perform any suitable digital conditioning of the converted digital signals, such as low pass, high pass, band pass, notch, averaging, or any other suitable filtering, amplifying, performing an operation on the signal, performing any other suitable digital conditioning, or any combination thereof. Additionally or alternatively, sensing circuitry 36 may include signal processing circuitry to modify one or more raw signals and communicate to processing circuitry 30 one or more modified signals.

[0101] Although shown as part of device 130 in FIG. 2, in other examples, sensing circuitry 36 can be a part of a device separate from device 130. For example, sensing circuitry 36 can be included in handle portion 150 of catheter system 108.

[0102] Processing circuitry 30, as well as other processors, processing circuitry, controllers, control circuitry, and the like, described herein, may include any combination of integrated circuitry, discrete logic circuity, analog circuitry, such as one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), or field-programmable gate arrays (FPGAs). In some examples, control circuitry may include multiple components, such as any combination of one or more microprocessors, one or more DSPs, one or more ASICs, or one or more FPGAs, as well as other discrete or integrated logic circuitry, and / or analog circuitry.

[0103] Memory 32 is configured to store program instructions, such as software, which may include one or more program modules, which are executable by processing circuitry 30. When executed by processing circuitry 30, such program instructions may cause processing circuitry 30 to provide the functionality ascribed to processing circuitry 30 herein. The program instructions may be embodied in software and / or firmware. Memory 32 may include any volatile, nonvolatile, magnetic, optical, or electrical media, such as a random-access memory (RAM), readonly memory (ROM), non-volatile RAM (NVRAM), electrically-erasable programmable ROM (EEPROM), flash memory, or any other digital media.

[0104] Processing circuitry 30 is configured to control telemetry circuitry 38 to send and receive information. Telemetry circuitry 38, as well as telemetry modules in other devices including an external computing device or an external user interface (e.g., display), may accomplish communication by any suitable communication techniques, such as radiofrequency (RF) communication techniques.

[0105] Power source 40 is configured to deliver operating power to various components of device 130. Power source 40 may include a rechargeable or non-rechargeable battery and a power generation circuit to produce the operating power. Power source 40 may be configured toPCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 deliver enough power for determining force and / or pressure values applied to sensor elements 114 carried by balloon 112.

[0106] FIG. 3A, FIG. 3B, and FIG. 3C illustrate one or more functionalities of system 100 according to the examples of this disclosure. FIG. 3 A is a schematic cross-sectional illustration of a portion of catheter system 108 within a blood vessel 102 of patient 106, the blood vessel 102 including vessel wall 104 and defining an inner dimension VI (which may be a diameter VI in the case of a circular or near-circular cross section). The components of catheter system 108 as shown in FIG. 3 A are configured according to the respective descriptions of the examples of FIG. 1 A, FIG. IB, FIG. 1C, and FIG. 2, except as described herein. FIG. 3B and FIG. 3C illustrate an example display 370 of an example user interface (e.g., user interface 132 of the example of FIG. 1 A and FIG. IB) displaying information related to pressures and / or forces determined based on signals from sensor elements 114. One or more components described in connection with FIG. 1 A, FIG. IB, FIG. 1C, and / or FIG. 2 may be referenced herein to further describe the functionality of such components (e.g., such as device 130, which can include processing circuitry 30).

[0107] In the example illustrated in FIG. 3 A, balloon 112 is delivered intravascularly to the treatment location (e.g., proximate a lesion 105) using a guidewire in an over the wire (OTW) technique or a rapid exchange (RX) technique. At the treatment location, the guidewire can be left inserted, and balloon 112 may be expanded from the delivery configuration to a partially expanded configuration (e.g., as shown in FIG. 3A) and / or to a fully expanded configuration. In some examples, the guidewire is removed or partially removed prior to inflating and / or expanding balloon 112. In some examples, balloon 112 may position sensor elements 114 proximate to stent 160, e.g., such that sensor elements can measures a reaction force and / or pressure of stent 160 as stent is expanded within blood vessel 102.

[0108] As illustrated in the example of FIG. 3 A, catheter system 108 additionally includes stent 160, which may be delivered and / or expanded via catheter system 108. In the example of FIG. 3 A, stent 160 is at least partially expanded against a portion of blood vessel 102 that includes lesion 105. Stent 160 is partially expanded because a portion of stent 160 abutting lesion 105 is narrowed compared to the largest diameter (e.g., diameter VI) of blood vessel 102. Lesion 105 may include any abnormal narrowing of blood vessel 102, including material in or within blood vessel 102 that be fibrous, calcific, fatty, thrombogenic, or a combination thereof.

[0109] In the example of FIG. 3A, balloon 112 is in an at-least partially expanded (e.g., inflated) configuration press against stent 160 with enough pressure to conform to the at least partially expanded diameter of stent 160.PCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001

[0110] In some examples, balloon 112 is configured to transform to a low-profile (e.g., delivery) configuration. In some examples, in the delivery configuration, defines a diameter small enough to be delivery across stent 160 (e.g., narrow enough to fit through an opening defined by the at least partially expanded stent 160).[OHl] In the example of FIG. 3A, balloon 112 is shown in at least partially expanded (e.g., inflated) configuration to exert pressure against stent 160 with enough pressure to conform to the at least partially expanded diameter of stent 160, but not enough pressure to further expand stent 160. At this point, a user (e.g., a clinician) may initiate, or processing circuitry 30 may automatically initiate, determination of one or more forces and / or pressures applied to sensor elements 114 and / or balloon 112. Such determination of one or more forces and / or pressures applied to sensor elements 114 can enable processing circuitry to determine (e.g., generate) a map of pressure values and / or force values applied by stent 160 against the portion of balloon 112 that includes sensor elements 114. In some examples, as discussed in relation to FIG. 3B and FIG. 3C, processing circuitry 30 determines (e.g., and / or generates, for output via user interface 132), based on the one or more forces and / or pressures applied to sensor elements 114, an indication of stent malapposition of stent 160 against vessel wall 104, a degree of stent apposition of stent 160 against vessel wall 104, an indication of a stent crimp zone of stent 160 (e.g., by determining areas of uniform low pressure along an axial length of balloon 112), and / or other relevant indices and / or parameters related to stent 160 and / or blood vessel 102.

[0112] In examples where balloon 112 is at least partially expanded directly against vessel wall 104 of blood vessel 102 (e.g., without stent 160 between balloon 112 and vessel wall 104, which can include a portion of vessel wall including lesion 105), processing circuitry 30 can be configured to determine (e.g., generate) a map of pressure values and / or force values applied by vessel wall 104 against the portion of balloon 112 that includes sensor elements 114. In some examples, processing circuitry 30 is configured to generate a map of force values and / or map of pressure values based on the one or more forces and / or pressures applied to (e.g., directly applied to) sensor elements 114 and / or balloon 112 by vessel wall 104. This feedback can enable a clinician to determine whether to further expand balloon 112 (e.g., to further compress lesion 105, which can include plaque). In some examples, balloon 112 can be used as a plain old balloon angioplasty (POBA) catheter.

[0113] In some examples where balloon 112 is expanded directly against a portion of vessel wall 104 that includes lesion 105, processing circuitry 30 can be configured to determine a shape and / or geometry of lesion 105 based on one or more forces and / or pressures applied to (e.g., directly applied to) sensor elements 114 and / or balloon 112 by vessel wall 104. For example,PCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 processing circuity 30 can be configured to determine a cross-sectional shape of lesion 105 based on force and / or pressure values corresponding to particular locations around balloon 112. Such information can enable a user (e.g., a clinician) determine whether clinical intervention is needed (e.g., whether to compress the lesion 105, which can include plaque via an angioplasty or stenting procedure). Such information can enable a user (e.g., a clinician) to select an appropriate stent (e.g., e.g., a sizing, including length and diameter of one or more stent), and / or make another clinically relevant decision.

[0114] FIG. 3B and FIG. 3C illustrate an example display 370 of an example user interface (e.g., user interface 132 of the example of FIG. 1 A and FIG. IB) displaying information related to pressures and / or forces determined based on signals from sensor elements 114. In some examples, as illustrated in FIG. 3B and FIG. 3C, processing circuitry 30 determines (e.g., calculates and / or generates, such as for output on user interface 132) a map of pressure values (e.g., such as one or more of a first map 371 of pressure values and a second map 372 of pressure values, as illustrated in FIG. 3B) based on one or more pressures applied by stent 160 and / or blood vessel wall 104 against balloon 112 and sensed by sensor elements 114. While the example of FIG. 3B and FIG. 3C is described in terms of pressure values and maps of pressure values, force values and / or maps of force values can additionally or alternatively be used. For example, any reference to force values and and / or maps of force values can additionally or alternatively include force values and / or maps of force values.

[0115] In some examples, as illustrated in the example of FIG. 3B, processing circuitry 30 generates, for output, an indication of a map of pressure values (e.g., such as one or more of first map 371 of pressure values and second map 372 of pressure values, as illustrated in FIG. 3B). In some examples, processing circuitry 30 generates the indication of the map of pressure values in conjunction with a representation of at least a portion of stent 360 (e.g., which may be a representation of stent 160, as shown and described in connection with at least FIG. 3 A). Representation of stent 360 can include a representation of struts 362 (which may be a representation of struts 162, as shown and described in connection with at least FIG. 3A). For example, as shown in the example of FIG. 3B, first map 371 of pressure values and a second map 372 of pressure values are overlaid with the representation of stent 360, which can enable a clinician to visually identify which portions of stent 360 are malapposed and / or adequately apposed against a blood vessel wall (e.g., blood vessel wall 104 of blood vessel 102 of FIG. 3A).

[0116] In some examples, as illustrated in the example of FIG. 3B, processing circuitry 30 generates, for output, an indication of a map of pressure values (e.g., such as one or more of first map 371 of pressure values and second map 372 of pressure values, as illustrated in FIG. 3B) inPCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 conjunction with a representation of one or more sensor elements 314 (e.g., which may be a representation of a portion of sensor elements 114, as shown and described in connection with at least FIG. 3 A). Representation of sensor elements 314 can include a representation of a portion of sensor elements 114 (e.g., such as a portion of sensor elements 114 that where individual sensor elements overlap with other sensor elements 114).

[0117] In some examples, the map of pressure values (e.g., first map 371 of pressure values and / or second map 372 of pressure values) extend between a proximal end 390A and a distal end 390B. In some examples, proximal end 390 A and distal end 390B correspond to a proximal end a distal end of a collection (e.g., a mesh) of sensor elements 114. In some examples, each of proximal end 390A and distal end 390B of first map 371 and / or second map 372 of pressure values are labeled, positioned, or otherwise demarcated to indicate to a user (e.g., a clinician) that proximal end 390 A corresponds to a proximal end of a collection (e.g., a mesh) of sensor elements 114 and distal end 390B corresponds to a distal end of the collection (e.g., the mesh) of sensor elements 114.

[0118] In some examples, as illustrated in FIG. 3B, processing circuitry 30 is configured to generate, for output, an indication of a map of pressure values (e.g., such as one or more of a first map 371 of pressure values and a second map 372 of pressure values, as illustrated in FIG. 3B) including a distribution of pressure values over mesh of sensor elements 114. In some examples, each of first map 371 of pressure values and second map 372 of pressure values correspond to different portions of stent 160. For example, in some examples, first map 371 of pressure values corresponds to a first portion of stent 160 and second map 372 can correspond to a second portion of stent 160. In some examples, first map 371 of pressure values corresponds to an anterior portion of stent 160 and second map 372 corresponds to a posterior portion of stent 160. In some examples, first map 371 of pressure values corresponds to a superior portion of stent 160 and second map 372 corresponds to an inferior portion of stent 160. Using multiple maps of pressure values (e.g., in such a split-view configuration as shown in FIG. 3B) that correspond to different portions of stent 160 can enable a user (e.g., a clinician) to more easily identify which portions of stent 160 correspond to low pressure and / or poor apposition of stent 160 and / or which portions of stent 160 correspond to an adequate pressure and / or adequate apposition of stent 160. In other examples, processing circuitry 30 generates a mapping of pressure values that includes a representation of stent 360 that includes the entire circumference of stent 160.

[0119] In some examples, processing circuity 30 is configured to determine one or more locations (e.g., one or more locations along and / or around stent 160, blood vessel 102, and / or balloon 112) of adequate apposition of stent 160 against vessel wall 104 and / or one or morePCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 locations of malapposition of stent 160 against vessel wall 104. For example, in some examples, processing circuitry 30 determines, based on the one or more pressures applied by stent 160 against balloon 112 (e.g., as measured by sensor elements 114) one or more locations of adequate apposition of stent 160 against vessel wall 104 and / or one or more locations of malapposition of stent 160 against vessel wall 104.

[0120] In some examples, catheter system 108 includes one or location references markers (e.g., radiopaque structures, such as markerbands positioned on elongated body 110). In some examples, one or more of sensor elements 114 themselves can serve as location references markers. In some examples, such location reference markers can enable a clinician and / or processing circuitry 30 to align a portion of balloon 112 (e.g., a body portion of balloon 112 of balloon between proximal and distal cones of balloon 112) with stent 160. For example, because one or more portions of stent 160 can be visible via a suitable medical imaging modality (e.g., fluoroscopy, angiography, radiography, and / or the like), a clinician can align a portion of balloon 112 that includes sensor elements 114 with a portion of stent 160. Such alignment can enable a user and / or processing circuitry 30 to determine which location of stent 160 is adequately apposed and / or malapposed against vessel wall 104.

[0121] In some examples, as illustrated in FIG. 3B, processing circuitry 30 is configured to generate, for output, an indication of a map of pressure values that includes at least three levels or three ranges of pressure values. For example, as shown in the example of FIG. 3B, processing circuitry 30 generates a first indication 382, which can correspond to a first range of pressure values, a second indication 384, which can correspond to a second range of pressure values, and a third indication 386, which can correspond to a third ranges of pressure values. In some examples, first indication 382 corresponds to a first range of pressure values that meets (e.g., is equal to and / or above) a first predetermined pressure threshold. In some examples, the first predetermined pressure threshold is 1000 kilopascals (kPa). In some examples, the first range of pressures associated with first indication 382 corresponds to adequate apposition of stent 160 against vessel wall 104 (e.g., adequate such that stent 160 does not need to be further expanded against vessel wall 104 of blood vessel 102). For example, measured pressure values above the first predetermined pressure threshold (e.g., 1000 kPa) correspond to adequate apposition of stent 160 against vessel wall 104.

[0122] In some examples, second indication 384 corresponds to a second range of pressure values that is between the first predetermined pressure threshold and a second predetermined pressure threshold (e.g., where pressures below the second predetermine pressure threshold are associated with areas of stent 160 that are malapposed against vessel wall 104). In somePCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 examples, the second predetermined pressure threshold is 100 kPa. In some examples, the second range of pressures associated with second indication 384 corresponds to a relatively lower pressure of stent 160 against vessel wall 104 (e.g., relatively lower pressure values as compared to first range of pressure values, such in the case that stent 160 is contacting vessel wall 104, but may be less than fully apposed). For example, measured pressure values between the second predetermined pressure threshold (e.g., 100 kPa) and the first predetermined pressure threshold (e.g., 1000 kPa) correspond to stent 160 contacting vessel wall 104, but less than fully apposed against vessel wall 104.

[0123] In some examples, third indication 386 corresponds to a third range of pressure values that does not meet (e.g., is below) the second predetermined pressure threshold (e.g., 100 kPa). In some examples, the third range of pressures associated with third indication 386 corresponds to inadequate apposition and / or malapposition of stent 160 against vessel wall (e.g., inadequate such that stent 160 needs to be expanded further against vessel wall 104 of blood vessel 102). In this way, processing circuitry 30 is configured to output indication of the one or more locations of adequate apposition and / or malapposition of stent 160 against blood vessel wall 104 of blood vessel 102.

[0124] In some examples, processing circuitry 30 determines, based on the one or more pressures applied by stent 160 against balloon 112 (e.g., measured and / or sensed pressure values) and one or more reference pressures, one or more degrees of apposition of the stent against the blood vessel wall. In some examples, degrees of stent apposition include qualitative measures of apposition of stent 160 against vessel wall 104 (e.g., adequate apposition, semi-adequate apposition, inadequate apposition). In some examples, such qualitative measures of apposition can be based on predetermined pressures thresholds associated with each of the degrees of apposition of stent 160 against vessel wall 104. In some examples, the one or more reference pressures include one or more predetermine pressure values. Such predetermine pressure values can be stored in memory 32 of device 130 (as shown and described in connection with FIG. 2) and / or input by a user (e.g., a clinician) prior to obtaining measurements via catheter system 108.

[0125] In some examples, processing circuitry 30 determines the one or more degrees of apposition of stent 160 against blood vessel wall 104 by comparing the one or more pressures by stent 160 against balloon 112 (e.g., measured and / or sensed pressure values) to at least one predefined threshold of one or more predefined pressure thresholds. In some examples, the one or more predefined pressure thresholds includes at least two predefined pressure thresholds (e.g., cutoffs). In some examples, the one or more predefined pressure thresholds includes at least three predefined pressure thresholds (e.g., cutoffs). In some examples, the predefined pressurePCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 thresholds can correspond to one or more of: adequate apposition of stent 160 against vessel wall 104, semi-adequate apposition of stent 160 against vessel wall 104, inadequate apposition of stent 160 against vessel wall, and / or malapposition of stent 160 against vessel wall 104. In this way, processing circuitry 30 can determine the one or more degrees of apposition of stent 160 against blood vessel wall 104 at least in part based on the comparison of measured pressure values (e.g., as measured by sensor elements 114 of balloon 112) and one or more predefined pressure thresholds.

[0126] In some examples, processing circuitry 30 generates, for output, the indication of the one or more degrees of apposition of the stent 160 against blood vessel wall 104. For example, as illustrated in FIG. 3B, processing circuitry 30 generates, for output, first indication 382 which corresponds to a first degree of apposition of apposition (e.g., adequate apposition of stent 160), second indication 384 which corresponds to a second degree of apposition (e.g., semi-adequate apposition of stent 160, and / or less than adequate apposition of stent 160), and / or third indication 386 that corresponds to a third degree of apposition of stent 160 (e.g., inadequate apposition and / or malapposition of stent 160). As illustrated in FIG. 3B, each of first indication 382, second indication 384, and / or third indication 386 can be overlaid on a corresponding location of representation of stent 360 such that each of first indication 382, second indication 384, and / or third indication 386 can indicate, such as to a user (e.g., a clinician) which specific areas (e.g., locations) of stent 160 exhibit which levels and / or degrees of apposition. Such information can enable a clinician to target and / or selectively expand particular portions of stent 160 (e.g., a distal portion, a proximal portion, or the like) to improve the apposition of stent 160 in such portions of stent 160. By selectively expanding only portions of stent 160 to reach an adequate level of apposition, over-expansion of adequately apposed portions of stent 160 can be reduced and / or entirely avoided.

[0127] In some examples, processing circuitry 30 generates, for output, the one or more degrees of apposition of stent 160 against blood vessel wall 104 based on comparisons of the one or more pressures (e.g., one or more pressure values) as measured by sensor elements 114 of balloon 112 to the one or more predefined pressure thresholds. For example, in some examples, one pressure threshold can correspond to stent 160 either having adequate apposition or inadequate apposition against blood vessel wall 104 (e.g., such that measured pressure values greater than or equal to the predefined pressure threshold correspond to adequate apposition of stent 160 against vessel wall 104 and measured pressure values less than the predefined pressure threshold correspond to inadequate apposition of stent 160 against vessel wall 104).PCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001

[0128] In some examples, processing circuitry 30 determines whether one or more pressures (e.g., one or more pressure values, as determined from the measured signals of sensor elements 114) meets and / or exceeds a predefined pressure threshold (e.g., a predefined threshold corresponding to adequate apposition of stent 160 for pressure values greater than or equal to the predefined threshold and corresponding to inadequate apposition of stent 160 for pressure values less than the predefined threshold). In this example, processing circuitry 30 includes an indication of adequate apposition of stent 160 against vessel wall 104 in the generated indication of the one or more degrees of apposition of stent 160 against vessel wall 104 based on the one or more pressures (e.g., one or more pressure values, as measured by sensor elements 114) meeting or exceeding the at least one predefined threshold of the one or more predefined pressure thresholds. Said another way, if the one or more pressures (e.g., as measured by sensor elements 114 of balloon 112) meets (e.g., is equal to) or exceeds (e.g., is greater than) the predefined pressure threshold, the indication of the degree of apposition of stent 160, as generated by processing circuitry 30, includes an indication of adequate apposition of stent 160 against blood vessel wall 104 (e.g., such as first indication 382 as illustrated in the example of FIG. 3B).

[0129] In some examples, processing circuitry 30 includes an indication of inadequate apposition of stent 160 against vessel wall 104 in the generated indication of the one or more degrees of apposition of stent 160 against vessel wall 104 based on the one or more pressures (e.g., one or more pressure values, as measured by sensor elements 114) not meeting or exceeding the at least one predefined threshold of the one or more predefined pressure thresholds. Said another way, if the one or more pressures (e.g., as measured by sensor elements 114 of balloon 112) does not meet (e.g., is less than) the predefined pressure threshold, the indication of the degree of apposition of stent 160, as generated by processing circuitry 30, includes an indication of inadequate apposition of the stent against the blood vessel wall (e.g., such as third indication 386 as illustrated in the example of FIG. 3B).

[0130] In some examples, processing circuitry 30 determines whether to include an indication of adequate apposition of stent 160 against blood vessel wall 104 in the indication of the one or more degrees of apposition of stent 160 against blood vessel wall 104 based on the determination of whether the one or more pressures (e.g., one or more pressure values, as measured by sensor elements 114) meets or exceeds the at least one predefined threshold of the one or more predefined pressure thresholds. In some examples, processing circuitry 30 does not include an indication of adequate apposition of stent 160 against blood vessel wall 104 if the one or more pressures (e.g., one or more pressure values, as measured by sensor elements 114) does not meet or exceed the at least one predefined threshold.PCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001

[0131] Any number of predefined pressure thresholds and / or ranges can be used for generating any number of degrees of apposition of stent 160 against vessel wall 104. Processing circuitry 30 can be configured to compare one or more pressures (e.g., one or more pressure values, as measured by sensor elements 114) against any number of predefined pressure threshold (e.g., one threshold, two thresholds, three thresholds, or more).

[0132] Each of first indication 382, second indication 384, and third indication 386 can correspond to a different color, hue, shading, pattern, another visual parameters, and / or a combination or sub-combination therefore such that first indication 382, second indication 384, and third indication 386 are visually distinct from each other. For example, in some examples, first indication 382 corresponds to a first color, second indication 384 corresponds to a second color different than the first color, and third indication 386 corresponds to a third color different than the first color and different than the second color.

[0133] In some examples, processing circuitry 30 generates, for output (e.g., on user interface 132) a legend 375. In some examples, processing circuitry 30 generates legend 375 in conjunction with one or more maps of pressure values (e.g., first map 371 of pressure values and second map 372 of pressure values). In some examples, legend 375 indicates a pressure value or a range of values for each of first indication 382, second indication 384, and / or third indication 386 (e.g., such that a user, such as a clinician, can correlate each of first indication 382, second indication 384, and third indication 386 to a pressure value and / or range of pressure values). In some examples, legend 375 additionally or alternatively includes one or more of an indication of the apposition of stent 160 against vessel wall 104 and / or an indication of the malapposition of stent 160 against vessel wall 104. In some examples, legend 375 includes text and / or or another visual indicator (e.g., an icon, picture, or the like) that correlates each of first indication 382, second indication 384, and third indication 386 to a corresponding level or degree of apposition of stent 160 against vessel wall 104. For example, in some examples, legend 375 indicates that first indication 382 corresponds to a first degree of apposition of apposition (e.g., adequate apposition of stent 160), second indication 384 corresponds to a second degree of apposition (e.g., semi-adequate apposition of stent 160, and / or less than adequate apposition of stent 160), and that third indication 386 corresponds to a third degree of apposition of stent 160 (e.g., inadequate apposition and / or malapposition of stent 160).

[0134] While the example of FIG. 3B shows three levels or ranges of pressure values, processing circuitry 30 can be configured to generate for output (e.g., on user interface 132) any suitable number of pressure levels and / or pressure ranges (e.g., levels of resolution), and as well as visual indicators corresponding to the any suitable number of pressure levels and / or pressurePCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 ranges (e.g., one, two, three, four, five, six, seven, eight, nine, ten, fifteen, twenty, forty, fifty, one-hundred pressure level(s) and / or range(s) of pressures). In some examples, processing circuitry 30 is configured to determine and / or generate a map of pressure values (e.g., either or both of first map 371 and second map 372) with one pressure level and / or range (e.g., that corresponds to either adequate apposition of stent 160 against vessel wall 104 or not). In such examples, processing circuitry 30 can generate a map of pressure values (e.g., either or both of first map 371 and second map 372) with a single color, pattern, shading, or other visual indicator showing areas of adequate stent apposition and / or inadequate apposition of stent 160 against vessel wall 104.

[0135] Based on the determined force values and / or pressure values, including a map of force values and / or pressure values, a clinician, or device 130 via processing circuitry 30, may further inflate balloon 112, e.g., to further expand balloon 112, which may further expand stent 160. As discussed herein, processing circuitry 30 can be configured to generate, for output (e.g., via user interface 132) an indication of force values and / or pressure values, including a map of force values and / or pressure values. Based on the output, a clinician may be enabled to decide whether further medical intervention (e.g., further expansion of stent 160) is warranted. In such examples where further intervention is warranted, the clinician may further inflate balloon 112, e.g., to a fully inflated configuration. In some examples, processing circuitry 30 is configured to automatically (e.g., without additional user input), cause device 130 to further inflate balloon 112, e.g., to the fully inflated configuration. For example, where a force value and / or pressure value is below a minimum threshold, processing circuitry 30 may configured to automatically (e.g., without additional user input), cause device 130 to further inflate balloon 112, e.g., to the fully inflated configuration.

[0136] Once balloon 112 has been expanded such as to expand stent 160 to a fully deployed diameter (e.g., to diameter VI as shown in the example of FIG. 3 A), a clinician and / or processing circuitry 30 may repeat determination of one or more pressure values and / or the map of pressure values. One or more cycles of expansion of balloon 112 and / or stent 160 may be performed, such as reach a desired level of stent expansion, stent apposition, etc. Further, determinations may be repeated a later time, such as after catheter system 108 has been removed from patient 106. In some examples, another device (e.g., a second catheter system 108) is introduced at a later time (e.g., for measurements to determine diameters or other related information). For example, follow up measurements may be taken hours, days, weeks, months, or years after initial placement of stent 160. However, in some examples, a clinician and / or processing circuitry 30PCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 only determines pressure values or related information at a single point in time (e.g., before stent placement, after stent placement and before post-dilation, or after post-dilation).

[0137] In some examples, processing circuitry 30 is configured to identify and evaluate a dissection of blood vessel 102. In some examples, a dissection of blood vessel 102 includes a tear (e.g., a partial tear) of lesion 105 and / or vessel wall 104 of vessel 102. In some examples, one or more of stent 160, a guidewire, a portion of a guidewire, etc. may cause the dissection of blood vessel 102. In some examples, processing circuitry 30 is configured to identify the dissection via sensor elements 114. For example, in some examples, processing circuitry 30 is configured to identify one or more discontinuities in a shape of vessel wall 104 of blood vessel 102 and / or lesion 105 over an axial length (e.g., a length of balloon 112). Processing circuitry 30 may classify the discontinuities in the shape of vessel wall 104 of blood vessel 102 and / or lesion 105 for determining whether the discontinuities include a dissection. For example, processing circuitry 30 may identify the dissection by classifying a discontinuity in the shape of vessel wall 104 of blood vessel 102 and / or lesion 105 (e.g., as above a predefined discontinuity threshold).

[0138] FIG. 3C illustrates an example display 370 of an example user interface (e.g., user interface 132 of the example of FIG. 1 A and FIG. IB) displaying information related to pressures and / or forces determined based on signals from sensor elements 114. In some examples, as illustrated in the example of FIG. 3C, processing circuitry 30 is configured to generate, for output, one or more indications of structural features of stent 160 and / or known areas of high and / or low pressures corresponding to stent 160. For example, when stent 160 is crimped onto a balloon (e.g., balloon 112), the crimping processing can cause certain portions of stent 160 to exhibit a relatively higher and / or lower pressures on balloon 112 and / or sensor elements 114 (e.g., once balloon 112 is expanded to cause stent 160 to expand to appose vessel wall 104). As discussed herein, in some examples, processing circuitry 30 is configured to determine (e.g., identify) areas (e.g., zones) corresponding to one or more locations of crimps along and / or around stent 160.

[0139] In some examples, as illustrated in the example of FIG. 3C, processing circuitry 30 generates, for output, third map 373 of pressure values. Third map 373 may be similar to each of first map 371 of pressure values and second map 372 of pressure values of FIG. 3B, except as described herein. In some examples, as illustrated in in FIG. 3C, processing circuitry 30 generates, for output, third map 373 of pressure values in conjunction with a representation of at least a portion of stent 360 (e.g., which may be a representation of stent 160, as shown and described in connection with at least FIG. 3 A). Representation of stent 360 can include aPCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 representation of struts 362 (which may be a representation of struts 162, as shown and described in connection with at least FIG. 3 A).

[0140] In some examples, processing circuitry 30 determines (e.g., identifies) one or more stent crimp zones along and / or around stent 160. For example, in some examples, processing circuitry 30 determines a stent crimp zone of stent 160 by at least detecting an area of uniform pressure along balloon 112 (e.g., as measured by sensor elements 114). In some examples, the area of uniform pressure along balloon 112 (e.g., as measured by sensor elements 114) corresponding to a stent crimp zone is a strip of uniform pressure extending axially along the surface of balloon 112 (e.g., in a direction along central longitudinal axis 111 of FIG. 3A). In some examples, the strip of uniform pressure extending axially along the surface of balloon 112 corresponding to a stent crimp zone includes a strip of relatively lower pressure as compared to positions circumferentially adjacent to the strip (e.g., as measured in a direction around central longitudinal axis 111 of FIG. 3 A). The relatively lower pressure associated with stent crimp zones could otherwise be mistaken as areas of malapposition of stent 160 (e.g., but such areas in reality are not considered true areas of malapposition of stent 160). As discussed herein, by being configured to determine (e.g., identify) stent crimp zones, processing circuitry 30 can generate, for output to a user (e.g., a clinician), one or more indications of stent crimp zones. Such indications can enable the user (e.g., a clinician) to differentiate stent crimp zones as compared to other portions of balloon 112, which can enable the user to make clinically relevant decision (e.g., whether or not to further expand stent 160) based on the indications of the stent crimp zones. In some examples, a user (e.g., a clinician) may choose to ignore stent crimp zones when deciding whether or not further intervention is necessary based on third map 373 of pressure values (e.g., whether or not to inflate balloon 112 more to cause further expansion of stent 160). By providing an indication of stent crimp zones along with third map 373 of pressure values, processing circuitry 30 can facilitate a relatively more accurate representation of different degrees of apposition of the stent (e.g., as compared to systems that cannot identify and / or differentiate stent crimp zones from other areas of relatively higher and / or lower pressures not associated with stent crimp zones).

[0141] As illustrated in FIG. 3C, in some examples, processing circuitry 30 generates, for output (e.g., on user interface 132) an indication of one or more stent crimp zones. For example, in some examples, processing circuitry 30 generates at least first indication 382, which can correspond to a first range of pressure values (e.g., as discussed above with respect to FIG. 3B), and a fourth indication 388, which can correspond to (e.g., indicate) a stent crimp zone. In some examples, fourth indication 388 that corresponds to a stent crimp zone can include a differentPCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 visual indicator (e.g., color different color, hue, shading, pattern, another visual parameters, and / or a combination or sub-combination) as compared to any other visual indicators presented on third map 373 of pressure values. In some examples, legend 375 includes text and / or another visual indicator to indicate that fourth indication 388 corresponds to a stent crimp zone.

[0142] In some examples, processing circuitry 30 generates, for output via user interface 132, the one or more stent crimp zones as one or more strips overlaid on third map 373 of pressure values. In some examples, processing circuitry 30 generates, for output via user interface 132, a label (e.g., text, icon, and / or the like) on or near one or more stent crimp zones. In some examples, as illustrated in FIG. 3C, the strips extend between proximal end 390A and distal end 390B of third map 373 of pressure values. Such indications of stent crimp zones can enable the user (e.g., a clinician) to visually identify stent crimp zones as compared to other portions of balloon 112, which can enable the user to make clinically relevant decision based on the indications of the stent crimp zones.

[0143] In other examples in which processing circuitry 30 determines a stent crimp zone, processing circuitry is configured to generate third map 373 of pressure values without an indication of the stent crimp zone (e.g., “ignore” the stent crimp zone). In particular, processing circuitry 30 can be configured to generate, for output, an indication of third map 373 of pressure values including a distribution of pressure values over the mesh of sensor elements 114 that does not include the area of uniform pressure along balloon 112 that corresponds to a stent crimp zone. For example, because some users (e.g., clinicians) may desire to ignore stent crimp zones when evaluating the degree of apposition of stent 160 against vessel wall 104, processing circuitry 30 can be configured to, either automatically or based on user input, generate third map 373 of pressure values without an indication of the one or more stent crimp zones (e.g., even though processing circuitry 30 has previously determined and / or identified one or more stent crimp zones). In other words, processing circuitry 30 can be configured to “ignore” certain areas of uniform pressure, such as stent crimp zones, and exclude from presentation indicators that correspond to such areas of uniform pressure, such as stent crimp zones.

[0144] In some examples, processing circuitry 30 identifies one or more other features of a stent in addition to or instead of a stent crimp zone via mesh of sensor elements 114. In some examples, processing circuity 30 identifies a location where one of sensor elements 114 overlaps with a stent strut (e.g., a location where one of sensor elements 114 is radially aligned with a stent strut). In some examples, processing circuity 30 identifies a location where one of sensor elements 114 overlaps with a stent cell (e.g., a location between struts). Such identification of struts and / or cells can enable to processing circuitry 30 and / or a user to determine shape and / orPCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 size of expanded cells of a stent. Additionally or alternatively, such identification of struts and / or cells of a stent can enable to processing circuitry 30 and / or a user to identify areas of mesh of sensor elements 114 that correspond to struts and / or cells.

[0145] An example technique for determining force values and / or pressure values (e.g., including map of force values and / or a map of pressure values), lesion morphology and / or one or more and / or other information using the catheter system described herein is illustrated in FIG. 4. The technique is described mainly with reference to medical device system 100 of FIG. 1 A, FIG. IB, and FIG. 1C, and processing circuitry 30 as discussed in connection with FIG. 2, however the technique may be applied to other medical systems in other examples.

[0146] The technique includes receiving, by processing circuitry 30, one or more signals from one or more sensor elements 114 carried by balloon 112 at distal body portion 110A of elongated body 110 (400). Processing circuitry 30 receives signals from one or more sensor elements 114 and determines, based on the received signals, one or more force values and / or pressure values, and / or morphological information (e.g., of lesion 105), or other information in accordance with this disclosure.

[0147] The technique includes determining, by processing circuitry 30, one or more of an indication of morphology (e.g., of lesion 105) or a map of force values and / or a map of pressure values (402). As discussed above, in some examples, processing circuitry 30 applies the received signal values to one or more of an equation, a model, a lookup table, and / or another relational method that relates voltage values (e.g., measured and / or recorded voltage values) from sensor elements 114 to pressure values and / or force values.

[0148] In some examples, the technique further includes generating, by processing circuitry 30, one or more outputs, such as for presentation via user interface 132 of device 130. In some examples, processing circuitry 30 generates, for output (e.g., such as via user interface 132 of device 130), an indication of a map of pressure values and / or a map of force values. In some examples, processing circuitry 30 generates map of pressure values and / or the map of force using known locations of sensor elements 114 relative to balloon 112. In some examples, processing circuitry generates, for output (e.g., such as via user interface 132 of device 130), an indication of the morphology of blood vessel 102 (e.g., which can include an indication of whether lesion 105 is a calcific lesion or a soft lesion, such as a lipid based lesion).

[0149] In some examples, the technique further includes determining and / or generating, by processing circuitry 30, other relevant measures and / or indices related to the determined force values and / or pressure values. For example, in some examples and as discussed throughout this disclosure, processing circuitry 30 determines one or more locations of malapposition of stentPCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001160 against blood vessel wall 104 and / or one or more degrees of apposition of stent 160 against blood vessel wall 104. In some examples and as discussed throughout this disclosure, processing circuitry 30 generates, for output (e.g., such as via user interface 132 of device 130), an indication of the one or more locations of malapposition of stent 160 against blood vessel wall 104 and / or an indication of the one or more degrees of apposition of stent 160 against blood vessel wall 104.

[0150] In some examples, the technique further includes determining and / or generating, by processing circuitry 30, indications related to stent crimp zones. For example, in some examples, the technique includes determining, by processing circuitry 30, a stent crimp zone of stent 160 by at least detecting an area of uniform pressure along balloon 112 (e.g., when balloon 112 is inflated and expanded against stent 160 such that sensor elements 114 are able to measure pressure along stent 160).

[0151] The techniques described in this disclosure, including those attributed to system 100, catheter system 108, device 130, or various constituent components, may be implemented, at least in part, in hardware, software, firmware or any combination thereof. For example, various aspects of the techniques may be implemented within one or more processors, including one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field-programmable gate array (FPGAs), or any other equivalent integrated or discrete logic circuitry, as well as any combinations of such components, embodied in programmers, such as clinician or patient programmers, medical devices, or other devices. Processing circuitry, control circuitry, and sensing circuitry, as well as other processors and controllers described herein, may be implemented at least in part as, or include, one or more executable applications, application modules, libraries, classes, methods, objects, routines, subroutines, firmware, and / or embedded code, for example. In addition, analog circuits, components and circuit elements may be employed to construct one, some or all of the processing circuitry 30, instead of or in addition to the partially or wholly digital hardware and / or software described herein. Accordingly, analog or digital hardware may be employed, or a combination of the two.

[0152] In one or more examples, the functions described in this disclosure may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored on, as one or more instructions or code, a computer- readable medium and executed by a hardware-based processing unit. The computer-readable medium may be an article of manufacture including a non-transitory computer-readable storage medium encoded with instructions. Instructions embedded or encoded in an article of manufacture including a non-transitory computer-readable storage medium encoded, may causePCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 one or more programmable processors, or other processors, to implement one or more of the techniques described herein, such as when instructions included or encoded in the non-transitory computer-readable storage medium are executed by the one or more processors. Example non- transitory computer-readable storage media may include random-access memory (RAM), readonly memory (ROM), programmable ROM (PROM), erasable programmable ROM (EPROM), electronically erasable programmable ROM (EEPROM), flash memory, a hard disk, a compact disc ROM (CD-ROM), a floppy disk, a cassette, magnetic media, optical media, or any other computer readable storage devices or tangible computer readable media.

[0153] In some examples, a computer-readable storage medium includes a non-transitory medium. The term “non-transitory” may indicate that the storage medium is not embodied in a carrier wave or a propagated signal. In certain examples, a non-transitory storage medium may store data that can, over time, change (e.g., in RAM or cache).

[0154] The functionality described herein may be provided within dedicated hardware and / or software modules. Depiction of different features as modules or units is intended to highlight different functional aspects and does not necessarily imply that such modules or units must be realized by separate hardware or software components. Rather, functionality associated with one or more modules or units may be performed by separate hardware or software components, or integrated within common or separate hardware or software components. Also, the techniques could be fully implemented in one or more circuits or logic elements.

[0155] As used herein, “about” and / or “substantially” can indicate the exact value or nearly the exact value to the extent permitted by manufacturing tolerances. “About” and / or “substantially” can also refer to a certain percentage of the recited value (e.g., within about 1%, 5%, or 10%).

[0156] This disclosure includes the following non-limiting examples.

[0157] Example 1 : A medical device system includes a catheter including: an elongated body configured to be inserted into a blood vessel of a patient, an expandable structure at a distal portion of the elongated body, and a plurality of sensor elements carried by the expandable structure including at least a first subset of sensor elements axially spaced apart along the expandable structure and a second subset of sensor elements circumferentially spaced apart around the expandable structure, wherein each sensor element of the first subset of sensor elements extends around an outer perimeter of the expandable structure and each sensor element of the second subset of sensor elements extends axially along the outer perimeter of the expandable structure such that the first subset of sensor elements and the second subset of sensor elements form a mesh of sensor elements; and processing circuitry configured to: receive, via thePCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 plurality of sensor elements, one or more signals, and determine, based on the one or more signals, one or more of: an indication of a morphology of a lesion of the blood vessel, or a map of pressure values based on one or more pressures applied by a stent or a blood vessel wall against the expandable structure.

[0158] Example 2: The medical device system of example 1, wherein the processing circuitry is configured to: generate, for output, an indication of the map of pressure values including a distribution of pressure values over the mesh of sensor elements.

[0159] Example 3: The medical device system of any of examples 1 or 2, wherein the processing circuitry is configured to: determine a stent crimp zone by at least detecting an area of uniform pressure along the expandable structure.

[0160] Example 4: The medical device system of example 3, wherein in response to determining the stent crimp zone, the processing circuitry is configured to: generate, for output, an indication of the stent crimp zone.

[0161] Example 5: The medical device system of any of example 3 and 4, wherein in response to determining the stent crimp zone, the processing circuitry is configured to: generate, for output, an indication of the map of pressure values including a distribution of pressure values over the mesh of sensor elements that does not include the area of uniform pressure along the expandable structure of the stent crimp zone.

[0162] Example 6: The medical device system of any of examples 1 through 5, wherein the indication of morphology of the lesion includes an indication of whether the lesion is a calcific lesion or a soft lesion.

[0163] Example 7: The medical device system of any of examples 1 through 6, wherein the processing circuitry is configured to: determine, based on the one or more pressures applied by the stent against the expandable structure, one or more locations of malapposition of the stent against the blood vessel wall, and generate, for output, an indication of the one or more locations of malapposition of the stent against the blood vessel wall.

[0164] Example 8: The medical device system of any of examples 1 through 7, wherein the processing circuitry is configured to: determine, based on the one or more pressures applied by the stent against the expandable structure and one or more reference pressures, one or more degrees of apposition of the stent against the blood vessel wall, and generate, for output, an indication of the one or more degrees of apposition of the stent against the blood vessel wall.

[0165] Example 9: The medical device system of example 8, wherein the one or more reference pressures includes one or more predefined pressure thresholds, and wherein to determine the one or more degrees of apposition of the stent against the blood vessel wall, thePCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 processing circuitry is configured to: compare the one or more pressures by the stent against the expandable structure to at least one predefined threshold of the one or more predefined pressure thresholds, and determine the one or more degrees of apposition of the stent against the blood vessel wall at least in part based on the comparison.

[0166] Example 10: The medical device system of example 9, wherein the processing circuitry is configured to: determine whether the one or more pressures meets or exceeds the at least one predefined threshold of the one or more pressure thresholds; based on the one or more pressures meeting or exceeding the at least one predefined threshold of the one or more predefined pressure thresholds, include an indication of adequate apposition of the stent against the blood vessel wall in the indication of the one or more degrees of apposition of the stent against the blood vessel wall; and based on the one or more pressures not meeting or exceeding the at least one predefined threshold of the one or more predefined pressure thresholds, include an indication of inadequate apposition of the stent against the blood vessel wall in the indication of the one or more degrees of apposition of the stent against the blood vessel wall.

[0167] Example 11 : The medical device system of any of examples 1 through 10, wherein the processing circuitry is configured to co-register the map of pressure values based on the one or more pressures applied by the stent or the blood vessel wall against the expandable structure with a separate medical imaging modality, the separate medical imaging modality selected from a group comprising angiography, computed tomography (CT), and magnetic resonance imaging (MRI).

[0168] Example 12: The medical device system of any of examples 1 through 11, wherein the expandable structure includes a balloon, the balloon configured to be inflated by a liquid.

[0169] Example 13: The medical device system of any of examples 1 through 12, wherein the expandable structure at the distal portion of the elongated body is configured to expand the stent against a wall of the blood vessel.

[0170] Example 14: The medical device system of any of examples 1 through 13, wherein the one or more sensor elements are disposed in one or more layers disposed around the expandable structure.

[0171] Example 15: The medical device system of example 14, wherein the one or more layers includes at least a first layer and a second layer surrounding the first layer, and wherein the first subset of sensor elements is disposed in the first layer and the second subset of sensor elements is disposed in the second layer.

[0172] Example 16: A method includes receiving, by processing circuitry, one or more signals from a plurality of sensor elements carried by an expandable structure, the expandablePCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 structure at a distal portion of an elongated body configured to be inserted into a blood vessel of a patient; and determining, by the processing circuitry and based on the one or more signals, one or more of: an indication of a morphology of a lesion of the blood vessel, or a map of pressure values based on one or more pressures applied by a stent or a blood vessel wall against the expandable structure, wherein the plurality of sensor elements includes at least a first subset of sensor elements axially spaced apart along the expandable structure and a second subset of sensor elements circumferentially spaced apart around the elongated body, and wherein each sensor element of the first subset of sensor elements extends around an outer perimeter of the expandable structure and each sensor element of the second subset of sensor elements extends axially along the outer perimeter of the expandable structure such that the first subset of sensor elements and the second subset of sensor elements form a mesh of sensor elements.

[0173] Example 17: The method of example 16, further includes generating, by the processing circuitry and for output, an indication of the map of pressure values including a distribution of pressure values over the mesh of sensor elements.

[0174] Example 18: The method of any of examples 16 or 17, further includes determining, by the processing circuitry, a stent crimp zone by at least detecting an area of uniform pressure along the expandable structure.

[0175] Example 19: The method of example 18, wherein the method further includes: in response to determining the stent crimp zone, generating, by the processing circuitry and for output, an indication of the stent crimp zone.

[0176] Example 20: The method of any of examples 18 and 19, wherein the method further includes: in response to determining the stent crimp zone, generating, by the processing circuitry and for output, an indication of the map of pressure values including a distribution of pressure values over the mesh of sensor elements that does not include the area of uniform pressure along the expandable structure of the stent crimp zone.

[0177] Example 21 : The method of any of examples 16 through 20, wherein the indication of morphology of the lesion includes an indication of whether the lesion is a calcific lesion or a soft lesion.

[0178] Example 22: The method of examples 16 through 21, further includes determining, by the processing circuitry and based on the one or more pressures applied by the stent against the expandable structure, one or more locations of malapposition of the stent against the blood vessel wall, and generating, by the processing circuitry and for output, an indication of the one or more locations of malapposition of the stent against the blood vessel wall.PCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001

[0179] Example 23: The method of any of examples 16 through 22, further includes determining, by the processing circuitry and based on the one or more pressures applied by the stent against the expandable structure and one or more reference pressures, one or more degrees of apposition of the stent against the blood vessel wall, and generating, by the processing circuitry and for output, an indication of the one or more degrees of apposition of the stent against the blood vessel wall.

[0180] Example 24: The method of example 23, wherein the one or more reference pressures includes one or more predefined pressure thresholds, and wherein determining the one or more degrees of apposition of the stent against the blood vessel wall includes: comparing, by the processing circuitry, the one or more pressures by the stent against the expandable structure to at least one predefined threshold of the one or more predefined pressure thresholds, and determining, by the processing circuitry, the one or more degrees of apposition of the stent against the blood vessel wall at least in part based on the comparison.

[0181] Example 25: The method of example 24, further includes determining, by the processing circuitry, whether the one or more pressures meets or exceeds the at least one predefined threshold of the one or more pressure thresholds; and determining, by the processing circuitry, whether to include an indication of adequate apposition of the stent against the blood vessel wall in the indication of the one or more degrees of apposition of the stent against the blood vessel wall based on the determination of whether the one or more pressures meets or exceeds the at least one predefined threshold of the one or more predefined pressure thresholds.

[0182] Example 26: The method of any of examples 16 through 25, further includes coregistering, by the processing circuitry, the map of pressure values based on the one or more pressures applied by the stent or the blood vessel wall against the expandable structure with a separate medical imaging modality, the separate medical imaging modality selected from a group comprising angiography, computed tomography (CT), and magnetic resonance imaging (MRI).

[0183] Example 27: The method of any of examples 16 through 26, wherein the expandable structure includes a balloon, the balloon configured to be inflated by a liquid.

[0184] Example 28: The method of any of examples 16 through 27, wherein the expandable structure at the distal portion of the elongated body is configured to expand the stent against a wall of the blood vessel.

[0185] Example 29: The method of any of examples 16 through 28, wherein the one or more sensor elements are disposed in one or more layers disposed around the expandable structure.

[0186] Example 30: The method of example 29, wherein the one or more layers includes at least a first layer and a second layer surrounding the first layer, and wherein the first subset ofPCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001 sensor elements is disposed in the first layer and the second subset of sensor elements is disposed in the second layer.

[0187] Example 31 : A medical device system includes an elongated body configured to be inserted into a blood vessel of a patient; an expandable structure at a distal portion of the elongated body; a plurality of sensor elements carried by the expandable structure that form a mesh of sensor elements; and processing circuitry configured to: receive, via the plurality of sensor elements, one or more signals that indicate one or more pressures applied by a stent against the expandable structure, determine, based on the one or more signals, a map of pressure values applied by the stent against the expandable structure, determine a stent crimp zone by at least detecting an area of uniform pressure along the expandable structure, and generate, for output, an indication of the map of pressure values including a distribution of pressure values over the mesh of sensor elements and an indication of the stent crimp zone.

[0188] Example 32: The medical device system of example 31, wherein the expandable structure at the distal portion of the elongated body is configured to expand the stent against a wall of the blood vessel.

[0189] Various examples of the disclosure have been described. Any combination of the described systems, operations, or functions is contemplated. These and other examples are within the scope of the following claims.

Claims

PCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W001WHAT IS CLAIMED IS:

1. A medical device system comprising: a catheter including: an elongated body configured to be inserted into a blood vessel of a patient, an expandable structure at a distal portion of the elongated body, and a plurality of sensor elements carried by the expandable structure including at least a first subset of sensor elements axially spaced apart along the expandable structure and a second subset of sensor elements circumferentially spaced apart around the expandable structure, wherein each sensor element of the first subset of sensor elements extends around an outer perimeter of the expandable structure and each sensor element of the second subset of sensor elements extends axially along the outer perimeter of the expandable structure such that the first subset of sensor elements and the second subset of sensor elements form a mesh of sensor elements; and processing circuitry configured to: receive, via the plurality of sensor elements, one or more signals, and determine, based on the one or more signals, one or more of: an indication of a morphology of a lesion of the blood vessel, or a map of pressure values based on one or more pressures applied by a stent or a blood vessel wall against the expandable structure.

2. The medical device system of claim 1, wherein the processing circuitry is configured to: generate, for output, an indication of the map of pressure values including a distribution of pressure values over the mesh of sensor elements.

3. The medical device system of any of claims 1 or 2, wherein the processing circuitry is configured to: determine a stent crimp zone by at least detecting an area of uniform pressure along the expandable structure.

4. The medical device system of claim 3, wherein in response to determining the stent crimp zone, the processing circuitry is configured to: generate, for output, an indication of the stent crimp zone.PCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W0015. The medical device system of any of claims 3 and 4, wherein in response to determining the stent crimp zone, the processing circuitry is configured to: generate, for output, an indication of the map of pressure values including a distribution of pressure values over the mesh of sensor elements that does not include the area of uniform pressure along the expandable structure of the stent crimp zone.

6. The medical device system of any of claims 1 through 5, wherein the indication of morphology of the lesion includes an indication of whether the lesion is a calcific lesion or a soft lesion.

7. The medical device system of any of claims 1 through 6, wherein the processing circuitry is configured to: determine, based on the one or more pressures applied by the stent against the expandable structure, one or more locations of malapposition of the stent against the blood vessel wall, and generate, for output, an indication of the one or more locations of malapposition of the stent against the blood vessel wall.

8. The medical device system of any of claims 1 through 7, wherein the processing circuitry is configured to: determine, based on the one or more pressures applied by the stent against the expandable structure and one or more reference pressures, one or more degrees of apposition of the stent against the blood vessel wall, and generate, for output, an indication of the one or more degrees of apposition of the stent against the blood vessel wall.

9. The medical device system of claim 8, wherein the one or more reference pressures includes one or more predefined pressure thresholds, and wherein to determine the one or more degrees of apposition of the stent against the blood vessel wall, the processing circuitry is configured to: compare the one or more pressures by the stent against the expandable structure to at least one predefined threshold of the one or more predefined pressure thresholds, and determine the one or more degrees of apposition of the stent against the blood vessel wall at least in part based on the comparison.PCT / US25 / 41374 08 August 2025 (08.08.2025)Docket No.: A0011683W001 / 1241-312W00110. The medical device system of claim 9, wherein the processing circuitry is configured to: determine whether the one or more pressures meets or exceeds the at least one predefined threshold of the one or more pressure thresholds; based on the one or more pressures meeting or exceeding the at least one predefined threshold of the one or more predefined pressure thresholds, include an indication of adequate apposition of the stent against the blood vessel wall in the indication of the one or more degrees of apposition of the stent against the blood vessel wall; and based on the one or more pressures not meeting or exceeding the at least one predefined threshold of the one or more predefined pressure thresholds, include an indication of inadequate apposition of the stent against the blood vessel wall in the indication of the one or more degrees of apposition of the stent against the blood vessel wall.

11. The medical device system of any of claims 1 through 10, wherein the processing circuitry is configured to co-register the map of pressure values based on the one or more pressures applied by the stent or the blood vessel wall against the expandable structure with a separate medical imaging modality, the separate medical imaging modality selected from a group comprising angiography, computed tomography (CT), and magnetic resonance imaging (MRI).

12. The medical device system of any of claims 1 through 11, wherein the expandable structure includes a balloon, the balloon configured to be inflated by a liquid.

13. The medical device system of any of claims 1 through 12, wherein the expandable structure at the distal portion of the elongated body is configured to expand the stent against a wall of the blood vessel.

14. The medical device system of any of claims 1 through 13, wherein the one or more sensor elements are disposed in one or more layers disposed around the expandable structure.

15. The medical device system of claim 14, wherein the one or more layers includes at least a first layer and a second layer surrounding the first layer, and wherein the first subset of sensor elements is disposed in the first layer and the second subset of sensor elements is disposed in the second layer.

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