Vulnerable arterial plaque identification

The guidewire system with temperature sensors provides a method to identify vulnerable plaques by generating a three-dimensional temperature profile and heat map, addressing the challenge of detecting unstable arterial plaques for timely intervention.

WO2025253228A1PCT designated stage Publication Date: 2025-12-11MEDTRONIC VASCULAR INC
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Patent Information

Application Number
PCT/IB2025/055460
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-06-05
Filing Date
2025-05-27
Publication Date
2025-12-11

AI Technical Summary

Technical Problem

Existing methods fail to effectively identify vulnerable plaques in arteries, which are a major cause of cardiovascular events such as heart attacks and strokes, due to their sudden rupture and blockage of blood flow.

Method used

A guidewire equipped with temperature sensors generates a three-dimensional temperature profile and heat map of arterial plaques, allowing for the identification of vulnerable plaques through thermal heterogeneity analysis.

Benefits of technology

Enables early detection and characterization of high-risk vulnerable plaques, facilitating timely intervention to reduce the risk of myocardial infarction and stroke.

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Abstract

A vulnerable plaque identification system includes a temperature-sensing guidewire and configured for use in identifying vulnerable plaque in an artery. A computing device receives the temperature signals from the guidewire, and generates a three-dimensional temperature profile of the plaque at the target site. The computing device can generate a three-dimensional heat map of the three-dimensional temperature profile of the plaque at the target site and / or analyze the three-dimensional temperature profile to determine whether the three-dimensional temperature profile of the plaque indicates vulnerable plaque.
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Description

VULNERABLE ARTERIAL PLAQUE IDENTIFICATIONCROSS-REFERENCE TO RELATED APPLICATION S)

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 656,452, filed June 5, 2024, which is incorporated herein by reference in its entirety.FIELD

[0002] The present technology is generally related to a vulnerable plaque identification system including a temperature-sensing guidewire and configured for use in identifying vulnerable plaque in an artery.BACKGROUND

[0003] Arterial plaque is made up of fat, cholesterol, calcium, fibrous tissue, and other substances, and overtime, the plaque can harden and narrow or block the lumen of the artery. The major cause (86%) of cardiovascular death in heart attacks and the major cause (45%) of deaths from brain aneurysms are from less obtrusive plaques known as “vulnerable plaques” that rupture suddenly and trigger a blood clot or thrombus that blocks blood flow.SUMMARY

[0004] The techniques of this disclosure generally relate to a vulnerable plaque identification system for use in identifying vulnerable plaque in an artery.

[0005] In one aspect, the present disclosure provides a vulnerable plaque identification system. The system comprises a guidewire including a guidewire body and a plurality of temperature sensors coupled to the guidewire body and spaced apart circumferentially around the guidewire body. The temperature sensors are configured to sense temperature of plaque at a target site within an artery of a subject and generate temperature signals indicative of the sensed temperature of the plaque as the guidewire is moved along the target site. A computing device includes a processing unit and memory storing processor- readable instructions that when executed by the processing unit cause the computing device to receive the temperature signals from the guidewire; generate a three-dimensional temperature profile of the plaque at the target site; and at least one of: (i) generate a three- dimensional heat map of the temperature profile of the plaque at the target site, and (ii)analyze the three-dimensional temperature profile to determine whether the three- dimensional temperature profile of the plaque indicates vulnerable plaque.

[0006] In another aspect, the disclosure provides a vulnerable plaque identification system. The system comprises a computing device including a processing unit and memory storing processor-readable instructions that when executed by the processing unit cause the computing device to: receive temperature signals from a guidewire that includes temperature sensors for detecting temperature of plaque at a target site in an artery; generate a three-dimensional temperature profile of the plaque at the target site; and at least one of: (i) generate a three-dimensional heat map of the temperature profile of the plaque at the target site, and (ii) analyze the three-dimensional temperature profile to determine whether the three-dimensional temperature profile of the plaque indicates vulnerable plaque.

[0007] In yet another aspect, the disclosure provides a guidewire for a plaque identification system. The guidewire comprises a guidewire body configured to be inserted into an artery and traversed to a target site of the artery. Temperature sensors are coupled to the guidewire body and spaced apart circumferentially around the guidewire body. The temperature sensors are configured to sense temperature of plaque at the target site and generate temperature signals indicative of the sensed temperature of the plaque as the guidewire is moved along the target site.

[0008] 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

[0009] FIG. 1 is a conceptual drawing of an embodiment of a vulnerable plaque identification system.

[0010] FIG. 2 is a conceptual drawing of a guidewire of the vulnerable plaque identification system received in an artery.

[0011] FIG. 3 is an enlarged view of a sensing element of an optical temperature sensor for the guidewire.

[0012] FIG. 4 is a perspective coupling portion of the guidewire including temperature sensors.

[0013] FIG. 5 is a side elevation of the coupling portion.

[0014] FIG. 6 is a side elevation of another embodiment of the coupling portion.

[0015] FIG. 7 is a schematic of an algorithm for operating a computing device of the vulnerable plaque identification system.DETAILED DESCRIPTION

[0016] Temperature differences correlate positively with cell macrophage density in atherosclerotic plaques. Thermal heterogeneity is increased in unstable atherosclerotic plaques compared to stable plaques, roughly by 0.3° C. from macrophage activity and the inflammatory response thereof. Early detection and characterization of this high-risk vulnerable plaque can identify patients who are unaware that they are at risk of suffering a myocardial infarction or other cardiovascular events such as stroke and possibly provide a therapy to stabilize this vulnerable plaque to reduce the risk of future infarction.

[0017] Referring to FIG. 1, to aid in detection of vulnerable plaque, a vulnerable plaque identification system is generally indicated at reference numeral 10. The system 10 generally includes a guidewire, generally indicated at 12, configured to sense temperature at a target site (e.g., plaque site) within an artery and generate temperature signals; and a computing device, generally indicated at 14, in communication with the guidewire and configured to process and / or analyze the temperature signals and generate image data indicative of a three-dimensional temperature profile of the plaque and / or analyze the temperature signals to identify vulnerable plaque. The system 10 may also include a display 18 for displaying the image indicative of the three-dimensional temperature profile. As explained below, the system 10 may be used with an angiography system 20, such as a fluoroscopy based angiogram, that is configured to generate images of the target site in the artery. The computing device 14 and the display 18 may be part of a console or other device.

[0018] Referring to FIGS. 1 and 2, the guidewire 12 includes a guidewire body 24 and a plurality of temperature sensors 26 coupled to the guidewire body at a distal end thereof. In one example, the guidewire body 24 may be constructed as a standard 0.014" guidewire body (i.e., guidewire having a nominal diameter of 0.014 in). The guidewire body 24 issuitably flexible and pushable to enable the guidewire 12 to traverse a patient's vasculature to the target site. In one example, the guidewire body 24 may comprise steel or nitinol core wires and solid core wire wrapped in a smaller wire coil or braid. The guidewire body 24 may comprise other materials such as Teflon and other lubricious coatings. The illustrated guidewire body 24 also includes a sensor coupling portion 28 on which the temperature sensors 26 are mounted, as explained in more detail below. The sensor coupling portion 28 may be disposed proximal of an atraumatic tip portion and distal of the remaining portion of the guidewire body 24. In one example, the coupling portion 28 may comprise or be formed from metal, plastic or another material.

[0019] In one or more embodiments, the temperature sensors 26 may be any suitable type of temperature sensor. As examples, the temperature sensors 26 may be piezoelectric sensors, resistance temperature detectors, infrared sensors, optical sensors, or semiconductor thermal sensors. In the illustrated embodiment, each of the temperature sensors 26 is an optical temperature sensor, such as a fiber optic based optical temperature sensor. Referring to FIG. 3, one example of the optical temperature sensor 26 is shown schematically. The sensor 26 includes a sensing element, generally indicated at 30, and an optical fiber 32 (e.g., single mode optical fiber). The optical fiber 32 may have a wavelength of 830 nm to 980 nm and a cladding diameter of 125 pm. A polymer 34, such as a silicone elastomer (e.g., polydimethylsiloxane - PDMS), is deposited on the distal end of the optical fiber to form a distal tip.

[0020] The sensing element 30 includes a silicone elastomer plug 36 (e.g., PDMS) received in a sensor body or capillary tube 38 (e.g., quartz capillary tube). The capillary tube 38 has a maximum outer diameter of about 250 pm or less, and in one example, the dimensions of the capillary tube may be 250 pm x 250 pm x 75 pm. The plug 36 has opposite concave surfaces forming a flexible membrane at a distal end of the capillary tube 38. The optical fiber 32 is received in the capillary tube 38 so that the tip 35 opposes the proximal concave surface of the plug 36 to create a cavity 40 therebetween. The optical fiber 32 may be secured inside the capillary tube 38 such as by an epoxy 41. The optical fibers 32 extend along the length of the guide wire body 24 to a proximal end of the guidewire body where they are in communication with a detector 42 (e.g., a spectrometer; FIG. 1) for receiving reflected interrogation light. A detailed explanation of the sensor 26and its operation is described in U.S. Patent Application Serial No. 16 / 963,793, filed January 22, 2019, the entirety of which is hereby incorporated by reference.

[0021] Referring to FIGS. 4 and 5, a suitable sensor coupling portion 28 is shown. The sensor coupling portion 28 includes at least two cavities 44 defined by the outer surface of the sensor coupling portion. Each cavity 44 is sized and shaped to receive the sensor body (e.g., capillary tube 38) of each of the temperature sensors 26 to enable thermal communication between the sensing elements 30 of the sensors and the artery (e.g., blood at target site and / or plaque at target site). Accordingly, the cavities 44 may have dimensions of about 250 pm x 250 pm. In this embodiment, the two sensors 26 are spaced 180 degrees apart around the circumference of the coupling portion 28. The sensors 26 may be co-planar and aligned around the circumference. In another embodiment, shown in FIG. 6, the sensors 26 (e.g., four sensors) are offset around the circumference, such that they are spaced apart longitudinally along the coupling portion 28.

[0022] In use, guidewire 12 is delivered to the target site in the artery such that the sensing elements 30 are adjacent the portion of the artery to be diagnosed. In one example the sensing elements 30 are positioned distal of the target site. Then the guidewire 12 is withdrawn or moved proximally along the target site, thereby moving the sensing elements 30 along the target site. During this proximal movement, the temperature sensors 26 sense the temperature at the target site. In particular, because the sensing elements 30 are disposed circumferentially around the guidewire body 24, the temperature sensors 26 generate temperature profile signals indicative of a 360-degree temperature profile of the target site. These temperature profile signals are communicated to the computing device 14, such as wireless or wired communication.

[0023] Referring to FIG. 1, the computing device 14 includes a processing unit 50 (e.g., one or more processors, such as microprocessors) and memory 52 storing processor- readable instructions (e.g., software) that which executed by the processing unit instruct the processor to perform certain operations, such as but not limited to signal processing, image processing, co-registration, and overlaying based on the received temperature profile signals.

[0024] Referring to FIG. 7, a suitable operation of the processing unit 50, based on the instructions stored in memory 52, is shown in the illustrated algorithm flowchart. At step 100, the computing device 14 is configured to receive the temperature profile signals fromthe guidewire 12. At step 102, the computing device 14 processes the signals to determine and compile the three-dimensional temperature profile at the target site. Using the temperature profile, at step 104 the computing device 14 generates heat map data or other visualization data of the temperature profile, whereby different colors are used to indicate different temperatures and / or different possible types of plaque at the target site. In one example, the color red indicates possible vulnerable plaque having above normal temperature, green indicates normal temperature seen in non-vulnerable plaque, and blue indicates sub temperature, possibly calcified plaque. As an example, the computing device 14 generates the three-dimensional heat map model of the target site by co-registering the data with data from an imaging system (e.g., fluoroscopy data) to spatially align the heat map with a three-dimensional model of the target site from the imaging system.). At step 106, the processing unit 50 displays, on the display 18, the heat map superimposed (i.e., overlaid) on the three-dimensional model of target site using image overlaying techniques so that the practitioner is able to visually locate detected vulnerable plaque along the target site. The displayed three-dimensional model with the overlaid heat map may also include graphical annotations, such as text, arrows, shapes, or symbols to highlight possible vulnerable plaque, provide context, or convey information. The heat map may be overlaid on another three-dimensional model from an angiography-based FFR (fractional flow reserve) system or other system displaying a three-dimensional model of the artery.

[0025] The vulnerable plaque identification system 10 facilitates early detection and characterization of high-risk vulnerable plaque. In real-time during an angiogram, for example, the practitioner can identify patients who are unaware that they are at risk of suffering a myocardial infarction or other cardiovascular events such as stroke and possibly provide a therapy to stabilize this vulnerable plaque to reduce the risk of future infarction.

[0026] The invention may be further described by reference to the following numbered paragraphs:1. A vulnerable plaque identification system comprising: a guide wire including a guide wire body and a plurality of temperature sensors coupled to the guidewire body and spaced apart circumferentially around the guidewire body, wherein the temperature sensors are configured to sense temperature of plaque at a target site within an artery of a subject and generate temperature signals indicative of thesensed temperature of the plaque as the guidewire is moved along the target site; a computing device including a processing unit and memory storing processor-readable instructions that when executed by the processing unit cause the computing device to: receive the temperature signals from the guidewire; generate a three-dimensional temperature profde of the plaque at the target site; and at least one of: (i) generate a three- dimensional heat map of the three-dimensional temperature profde of the plaque at the target site, and (ii) analyze the three-dimensional temperature profde to determine whether the three-dimensional temperature profde of the plaque indicates vulnerable plaque.2. The vulnerable plaque identification system set forth in paragraph 2, wherein the processor-readable instructions, when executed by the processing unit, cause the computing device to generate the three-dimensional heat map of the three-dimensional temperature profde of the plaque at the target site.3. The vulnerable plaque identification system set forth in paragraph 2, wherein the computing device generates the three-dimensional temperature profde by coregistering the temperature signals with image data of the treatment site from a separate imaging system.4. The vulnerable plaque identification system set forth in any one of paragraphs 2 or 3, wherein the image data of the treatment site is angiography data from an angiography system.5. The vulnerable plaque identification system set forth in paragraph 4, wherein the angiography data is fluoroscopy data from a fluoroscopy angiography system.6. The vulnerable plaque identification system set forth in any one of paragraphs 2 to 5, wherein the processor-readable instructions, when executed by the processing unit, cause the computing device to display the three-dimensional heat map on a display.7. The vulnerable plaque identification system set forth in paragraph 6, wherein on the display the three-dimensional heat map is superimposed on a three- dimensional model of the target site generated from image data from the imaging system.8. The vulnerable plaque identification system set forth in paragraph 7, wherein the processor-readable instructions, when executed by the processing unit, cause the computing device to (i) analyze the three-dimensional temperature profile to determine whether the three-dimensional temperature profile of the plaque indicates vulnerableplaque, and (ii) indicate location of the vulnerable plaque relative to the three-dimensional model on the display.9. The vulnerable plaque identification system set forth in any one of paragraphs 1 to 8, wherein the processor-readable instructions, when executed by the processing unit, cause the computing device to (i) analyze the three-dimensional temperature profile to determine whether the three-dimensional temperature profile of the plaque indicates vulnerable plaque.10. The vulnerable plaque identification system set forth in any one of paragraphs 1 to 8, wherein the temperature sensors are optical temperature sensors.11. A vulnerable plaque identification system comprising: a computing device including a processing unit and memory storing processor-readable instructions that when executed by the processing unit cause the computing device to: receive temperature signals from a guidewire that includes temperature sensors for detecting temperature of plaque at a target site in an artery; generate a three-dimensional temperature profile of the plaque at the target site; and at least one of: (i) generate a three-dimensional heat map of the temperature profile of the plaque at the target site, and (ii) analyze the three- dimensional temperature profile to determine whether the three-dimensional temperature profile of the plaque indicates vulnerable plaque.12. The vulnerable plaque identification system set forth in paragraph 11, wherein the processor-readable instructions, when executed by the processing unit, cause the computing device to generate the three-dimensional heat map of the temperature profile of the plaque at the target site.13. The vulnerable plaque identification system set forth in any one of paragraphs 11 or 12, wherein the computing device generates the three-dimensional temperature profile by co-registering the temperature signals with image data of the treatment site from a separate imaging system.14. The vulnerable plaque identification system set forth in paragraph 13, wherein the image data of the treatment site is angiography data from an angiography system.15. The vulnerable plaque identification system set forth in any one of paragraphs 11 to 14, wherein the processor-readable instructions, when executed by the processing unit, cause the computing device to (i) analyze the three-dimensionaltemperature profile to determine whether the three-dimensional temperature profile of the plaque indicates vulnerable plaque, and (ii) indicate location of the vulnerable plaque relative to a three-dimensional model of the artery on the display.16. The vulnerable plaque identification system set forth in paragraph 11, wherein the processor-readable instructions, when executed by the processing unit, cause the computing device to (i) analyze the three-dimensional temperature profile to determine whether the three-dimensional temperature profile of the plaque indicates vulnerable plaque.17. A guidewire for a plaque identification system, the guidewire comprising: a guidewire body configured to be inserted into an artery and traversed to a target site of the artery; and a plurality of temperature sensors coupled to the guidewire body and spaced apart circumferentially around the guidewire body, wherein the temperature sensors are configured to sense temperature of plaque at the target site and generate temperature signals indicative of the sensed temperature of the plaque as the guidewire is moved along the target site.18. The guidewire set forth in paragraph 17, wherein each temperature sensor is an optical temperature sensor including an optical sensing element adjacent a distal end of the guidewire body.19. The guidewire set forth in paragraph 18, further comprising at least one optical fiber in communication with the optical sensing elements and extending along the guidewire body.20. The guidewire set forth in paragraph 17, wherein the optical sensing element has a maximum outer dimension no greater than 250 pm.

[0027] It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the techniques). In addition, while certain aspects of this disclosure are described as being performed by a single module or unit for purposes of clarity, it should be understood that the techniques of thisdisclosure may be performed by a combination of units or modules associated with, for example, a medical device.

[0028] In one or more examples, the described techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Computer-readable media may include non-transitory computer-readable media, which corresponds to a tangible medium such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).

[0029] Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry. Accordingly, the term “processor” as used herein may refer to any of the foregoing structure or any other physical structure suitable for implementation of the described techniques. Also, the techniques could be fully implemented in one or more circuits or logic elements.

[0030] The following examples are illustrative of the techniques described herein.

[0031] Example 1. A vulnerable plaque identification system comprising:a guidewire including a guidewire body and a plurality of temperature sensors coupled to the guide wire body and spaced apart circumferentially around the guidewire body, wherein the temperature sensors are configured to sense temperature of plaque at a target site within an artery of a subject and generate temperature signals indicative of the sensed temperature of the plaque as the guidewire is moved along the target site; a computing device including a processing unit and memory storing processor-readable instructions that when executed by the processing unit cause the computing device to: receive the temperature signals from the guidewire; generate a three-dimensional temperature profile of the plaque at the target site; and at least one of: (i) generate a three-dimensional heat map of the three-dimensional temperature profile of the plaque at the target site, and (ii) analyze the three-dimensional temperature profile to determine whether the three-dimensional temperature profile of the plaque indicates vulnerable plaque.

[0032] Example 2. The vulnerable plaque identification system set forth in example 2, wherein the processor-readable instructions, when executed by the processing unit, cause the computing device to generate the three-dimensional heat map of the three-dimensional temperature profile of the plaque at the target site.

[0033] Example 3. The vulnerable plaque identification system set forth in example 2, wherein the computing device generates the three-dimensional temperature profile by coregistering the temperature signals with image data of the treatment site from a separate imaging system.

[0034] Example 4. The vulnerable plaque identification system set forth in any one of examples 2 or 3, wherein the image data of the treatment site is angiography data from an angiography system.

[0035] Example 5. The vulnerable plaque identification system set forth in example 4, wherein the angiography data is fluoroscopy image data from a fluoroscopy angiography system.

[0036] Example 6. The vulnerable plaque identification system set forth in any one of examples 2 to 5, wherein the processor-readable instructions, when executed by the processing unit, cause the computing device to display the three-dimensional heat map on a display.

[0037] Example 7. The vulnerable plaque identification system set forth in example 6, wherein on the display the three-dimensional heat map is superimposed on a three- dimensional model of the target site generated from image data from the imaging system.

[0038] Example 8. The vulnerable plaque identification system set forth in example 7, wherein the processor-readable instructions, when executed by the processing unit, cause the computing device to (i) analyze the three-dimensional temperature profile to determine whether the three-dimensional temperature profile of the plaque indicates vulnerable plaque, and (ii) indicate location of the vulnerable plaque relative to the three-dimensional model on the display.

[0039] Example 9. The vulnerable plaque identification system set forth in any one of examples 1 to 8, wherein the processor-readable instructions, when executed by the processing unit, cause the computing device to (i) analyze the three-dimensional temperature profile to determine whether the three-dimensional temperature profile of the plaque indicates vulnerable plaque.

[0040] Example 10. The vulnerable plaque identification system set forth in any one of examples 1 to 8, wherein the temperature sensors are optical temperature sensors.

[0041] Example 11. A vulnerable plaque identification system comprising: a computing device including a processing unit and memory storing processor-readable instructions that when executed by the processing unit cause the computing device to: receive temperature signals from a guidewire that includes temperature sensors for detecting temperature of plaque at a target site in an artery; generate a three-dimensional temperature profile of the plaque at the target site; and at least one of: (i) generate a three-dimensional heat map of the temperature profile of the plaque at the target site, and (ii) analyze the three-dimensional temperature profile to determine whether the three-dimensional temperature profile of the plaque indicates vulnerable plaque.

[0042] Example 12. The vulnerable plaque identification system set forth in example 11, wherein the processor-readable instructions, when executed by the processing unit, cause the computing device to generate the three-dimensional heat map of the temperature profile of the plaque at the target site.

[0043] 13. The vulnerable plaque identification system set forth in any one of examples 11 or 12, wherein the computing device generates the three-dimensional temperature profile by co-registering the temperature signals with image data of the treatment site from a separate imaging system.

[0044] Example 14. The vulnerable plaque identification system set forth in example 13, wherein the image data of the treatment site is angiography data from an angiography system.

[0045] Example 15. The vulnerable plaque identification system set forth in any one of examples 11 to 14, wherein the processor-readable instructions, when executed by the processing unit, cause the computing device to (i) analyze the three-dimensional temperature profile to determine whether the three-dimensional temperature profile of the plaque indicates vulnerable plaque, and (ii) indicate location of the vulnerable plaque relative to a three-dimensional model of the artery on the display.

[0046] Example 16. The vulnerable plaque identification system set forth in example 11, wherein the processor-readable instructions, when executed by the processing unit, cause the computing device to (i) analyze the three-dimensional temperature profile to determine whether the three-dimensional temperature profile of the plaque indicates vulnerable plaque .

[0047] Example 17. A guidewire for a plaque identification system, the guidewire comprising: a guidewire body configured to be inserted into an artery and traversed to a target site of the artery; and a plurality of temperature sensors coupled to the guidewire body and spaced apart circumferentially around the guidewire body, wherein the temperature sensors are configured to sense temperature of plaque at the target site and generate temperature signals indicative of the sensed temperature of the plaque as the guidewire is moved along the target site.

[0048] Example 18. The guidewire set forth in example 17, wherein each temperature sensor is an optical temperature sensor including an optical sensing element adjacent a distal end of the guidewire body.

[0049] Example 19. The guidewire set forth in example 18, further comprising at least one optical fiber in communication with the optical sensing elements and extending along the guide wire body.

[0050] Example 20. The guidewire set forth in example 17, wherein the optical sensing element has a maximum outer dimension no greater than 250 pm.

Claims

WHAT IS CLAIMED IS:

1. A vulnerable plaque identification system comprising: a computing device including a processing unit and memory storing processor- readable instructions that when executed by the processing unit cause the computing device to: receive temperature signals from a guidewire that includes temperature sensors for detecting temperature of plaque at a target site in an artery; generate a three-dimensional temperature profile of the plaque at the target site; and at least one of: (i) generate a three-dimensional heat map of the temperature profile of the plaque at the target site, and (ii) analyze the three-dimensional temperature profile to determine whether the three-dimensional temperature profile of the plaque indicates vulnerable plaque.

2. The vulnerable plaque identification system set forth in claim 1, wherein the processor-readable instructions, when executed by the processing unit, cause the computing device to generate the three-dimensional heat map of the temperature profile of the plaque at the target site.

3. The vulnerable plaque identification system set forth in any one of claims 1 or 2, wherein the computing device generates the three-dimensional temperature profile by co-registering the temperature signals with image data of the treatment site from a separate imaging system.

4. The vulnerable plaque identification system set forth in claim 3, wherein the image data of the treatment site is angiography data from an angiography system.

5. The vulnerable plaque identification system set forth in any one of claims 1 to 4, wherein the processor-readable instructions, when executed by the processing unit, cause the computing device to (i) analyze the three-dimensional temperature profile to determine whether the three-dimensional temperature profile of the plaque indicatesvulnerable plaque, and (ii) indicate location of the vulnerable plaque relative to a three- dimensional model of the artery on the display.

6. The vulnerable plaque identification system set forth in claim 1, wherein the processor-readable instructions, when executed by the processing unit, cause the computing device to (i) analyze the three-dimensional temperature profile to determine whether the three-dimensional temperature profile of the plaque indicates vulnerable plaque.

7. The vulnerable plaque identification system set forth in any one of claims 1-6 further comprising: a guidewire including a guidewire body and a plurality of temperature sensors coupled to the guidewire body and spaced apart circumferentially around the guidewire body, wherein the temperature sensors are configured to sense temperature of plaque at a target site within an artery of a subject and generate temperature signals indicative of the sensed temperature of the plaque as the guidewire is moved along the target site.

8. The guidewire set forth in claim 7, wherein each temperature sensor is an optical temperature sensor including an optical sensing element adjacent a distal end of the guide wire body.

9. The guidewire set forth in claim 8, further comprising at least one optical fiber in communication with the optical sensing elements and extending along the guidewire body.

10. The guidewire set forth in claim 9, wherein the optical sensing element has a maximum outer dimension no greater than 250 pm.

11. A guidewire for a plaque identification system, the guidewire comprising: a guidewire body configured to be inserted into an artery and traversed to a target site of the artery; anda plurality of temperature sensors coupled to the guide wire body and spaced apart circumferentially around the guidewire body, wherein the temperature sensors are configured to sense temperature of plaque at the target site and generate temperature signals indicative of the sensed temperature of the plaque as the guide wire is moved along the target site.

12. The guidewire set forth in claim 11, wherein each temperature sensor is an optical temperature sensor including an optical sensing element adjacent a distal end of the guide wire body.

13. The guidewire set forth in claim 12, further comprising at least one optical fiber in communication with the optical sensing elements and extending along the guide wire body.

14. The guidewire set forth in claim 11, wherein the optical sensing element has a maximum outer dimension no greater than 250 pm.

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