阅读说明：本技术 管内装置移动速度指导和相关联的装置、系统和方法 (In-line device movement speed guidance and associated devices, systems, and methods ) 是由 F·梅里特 于 2019-08-28 设计创作，主要内容包括：在一个实施例中,公开了一种医疗系统。该医疗系统的一个实施例包括医疗处理单元,其与被配置成在身体管腔内纵向地移动的管内器械通信,并且还与被配置成在管内器械在身体管腔内纵向地移动时获得管内器械的放射线照相图像的放射线照相成像源通信。医疗处理单元被配置成：接收由放射线照相成像源获得的放射线照相图像；在管内器械在身体管腔内纵向地移动时在放射线照相图像内跟踪管内器械；基于跟踪计算移动速度；将计算出的移动速度与预定义的目标移动速度进行比较；基于比较生成速度调节建议；以及将速度调节建议输出到显示器以供用户查看。(In one embodiment, a medical system is disclosed. One embodiment of the medical system includes a medical processing unit in communication with an intravascular device configured to move longitudinally within a body lumen, and also in communication with a radiographic imaging source configured to obtain radiographic images of the intravascular device as the intravascular device moves longitudinally within the body lumen. The medical processing unit is configured to: receiving a radiographic image obtained by a radiographic imaging source; tracking the intravascular device within the radiographic image as the intravascular device is moved longitudinally within the body lumen; calculating a movement speed based on the tracking; comparing the calculated moving speed with a predefined target moving speed; generating a speed adjustment recommendation based on the comparison; and outputting the speed adjustment suggestion to a display for viewing by a user.)

1. A medical system, comprising:

a medical processing unit in communication with an intravascular instrument configured to move longitudinally within a body lumen and further in communication with a radiographic imaging source configured to obtain radiographic images of the intravascular instrument as the intravascular instrument moves longitudinally within the body lumen, wherein the medical processing unit is configured to:

receiving a radiographic image obtained by the radiographic imaging source;

tracking the intravascular instrument within the radiographic image as the intravascular instrument is moved longitudinally within the body lumen;

calculating a movement speed based on the tracking;

comparing the calculated moving speed with a predefined target moving speed;

generating a speed adjustment recommendation based on the comparison result; and

outputting the speed adjustment suggestion to a display for viewing by a user.

2. The medical system of claim 1, wherein the predefined target movement speed is between 1 and 3 millimeters/second, inclusive.

3. The medical system of claim 1, wherein calculating the movement velocity includes compensating for motion of a heartbeat.

4. The medical system of claim 1, wherein the intravascular device comprises an intravascular ultrasound (IVUS) catheter.

5. The medical system of claim 1, wherein the intravascular device includes a pressure sensing guidewire.

6. The medical system of claim 1, wherein the intravascular device includes a radiopaque marker, and tracking the intravascular device within the radiographic image includes tracking the radiopaque marker within the radiographic image.

7. The medical system of claim 1, wherein the speed adjustment advice includes advice to increase a speed at which the intravascular device moves within the body lumen when the calculated movement speed is below the target movement speed.

8. The medical system of claim 1, wherein the speed adjustment advice includes advice to reduce a speed at which the intravascular device moves within the body lumen when the calculated movement speed is above the target movement speed.

9. The medical system of claim 1, wherein the speed adjustment recommendation includes a recommendation to maintain a speed at which the intravascular device moves within the body lumen when the calculated movement speed matches the target movement speed.

10. The medical system of claim 1, wherein calculating the movement velocity includes accounting for movement of the intravascular device through the body lumen in a Z-plane.

11. The medical system of claim 10, wherein accounting for movement of the intravascular device through the body lumen in the Z plane is based on analysis of radiographic images obtained during biplane angiography.

12. The medical system of claim 10, wherein accounting for movement of the intravascular device through the body lumen in the Z-plane is based on analysis of anatomical data related to the structure of the body lumen.

13. A method, comprising:

receiving, by a medical processing unit in communication with a radiographic imaging source, a radiographic image of an intravascular device located within a body lumen, the radiographic image obtained by the radiographic imaging source;

tracking, by the medical processing unit, the intravascular instrument within the radiographic image as the intravascular instrument is moved longitudinally within the body lumen;

calculating, by the medical processing unit, a movement speed based on the tracking;

comparing, by the medical processing unit, the calculated movement speed with a predefined target movement speed;

generating, by the medical processing unit, a speed adjustment recommendation based on the comparison; and

outputting, by the medical processing unit, the speed adjustment suggestion to a display for viewing by a user.

14. The method of claim 13, wherein the predefined target movement speed comprises a target range between 1 mm/sec and 3 mm/sec, the target range including end points.

15. The method of claim 13, wherein the speed adjustment recommendation comprises a graphical image configured to instruct the user to increase, decrease, or maintain a speed at which the intravascular instrument moves within the body lumen.

16. The method of claim 13, wherein the speed adjustment advice comprises textual instructions for increasing, decreasing, or maintaining a speed at which the intravascular instrument moves within the body lumen.

17. The method of claim 13, wherein the speed adjustment advice comprises advice for repeating a pullback operation.

18. The method of claim 13, wherein the intravascular instrument comprises an intravascular ultrasound (IVUS) catheter.

19. The method of claim 13, wherein the intravascular device comprises a pressure sensing guidewire.

20. The method of claim 13, wherein calculating the movement velocity comprises compensating for motion of a heartbeat.

Technical Field

The present disclosure relates generally to the field of intravascular medical devices for assessing the severity of obstructions or other restrictions to the flow of fluid (e.g., blood) through a vessel. Aspects of the present disclosure include continuously calculating a speed of movement of an intravascular instrument during an intravascular operation, and providing real-time feedback to a user and guidance for achieving a target speed of movement.

Background

Cardiovascular disease (CVD) has risen dramatically since the last decade. The number of deaths recorded in 2008 was 1,730 ten thousand (about 30% of the worldwide deaths), with an estimated 2,330 ten thousand reaching by 2030. Heart disease and stroke are the major causes of total loss due to CVD, resulting in the death of 730 and 620 million people, respectively. The developing and less developed countries in the world account for a large percentage of the total CVD burden (almost 80%). The national population census of india in 2010-11 recorded that the number of deaths due to circulatory diseases reached an astonishing 30 million, accounting for 29.8% of the total number of deaths. One of the main causes of CVD is the presence of obstructions or lesions in the vessel that attenuate flow. For example, the accumulation of plaque within a blood vessel can eventually lead to occlusion of the blood vessel by forming a partial or even complete occlusion. The formation of such obstructions can be life threatening, often requiring surgical intervention to save the lives of the afflicted individuals.

Currently accepted techniques for assessing the severity of intravascular stenosis (including the ischemic causing lesions) include Fractional Flow Reserve (FFR) and iFR (instantaneous wave-free ratio). FFR is the calculation of the ratio of the distal pressure measurement (taken distal to the stenosis) to the proximal pressure measurement (taken proximal to the stenosis). iFR is the calculation of the ratio of the distal pressure measurement to the proximal pressure measurement using the pressure measurements obtained during the diagnostic window of the heartbeat/heart cycle when the resistance is naturally constant and minimized. FFR and iFR provide an indication of the severity of the stenosis, which may allow a determination of whether the occlusion limits blood flow within the vessel to a degree that requires treatment.

Given the severity and widespread occurrence of CVD, there remains a need for improved devices, systems, and methods for assessing obstructions within vessels, particularly stenoses within blood vessels.

Disclosure of Invention

Aspects of the present disclosure include a medical processing unit that provides guidance to a user for achieving a target movement speed of an intravascular instrument during an intravascular operation (e.g., a pullback operation). For example, embodiments of the present disclosure include a medical processing unit that tracks an intravascular instrument in radiographic images and uses the tracking to calculate the speed of movement of the intravascular instrument as it moves through a body lumen, such as a blood vessel. The medical processing unit may then provide guidance to the user to assist the user in achieving the target movement speed. In this regard, the medical processing unit may instruct the user to increase, decrease, or maintain the speed in order to achieve the target movement speed. Such guidance advantageously increases the likelihood that the intravascular instrument will be moved at a suitable speed for intravascular data acquisition and co-registration of the intravascular data with radiographic images. Thus, such guidance also advantageously increases efficiency by reducing the likelihood of repeating the in-tube procedure due to poor data and/or inaccurate co-registration. The apparatus, system, and associated methods of the present disclosure overcome one or more deficiencies of the prior art.

In one embodiment, a medical system is disclosed. The medical system includes a medical processing unit in communication with an intravascular device configured to move longitudinally within a body lumen and also in communication with a radiographic imaging source configured to obtain radiographic images of the intravascular device as the intravascular device moves longitudinally within the body lumen. The medical processing unit is configured to: receiving a radiographic image obtained by a radiographic imaging source; tracking the intravascular device within the radiographic image as the intravascular device is moved longitudinally within the body lumen; calculating a movement speed based on the tracking; comparing the calculated moving speed with a predefined target moving speed; generating a speed adjustment recommendation based on the comparison; and outputting the speed adjustment suggestion to a display for viewing by a user.

In some embodiments, the predefined target movement speed is between 1 mm/sec and 3 mm/sec, inclusive. In some embodiments, calculating the movement velocity includes compensating for motion of the heartbeat. In some embodiments, the intravascular device comprises an intravascular ultrasound (IVUS) catheter. In some embodiments, the intravascular device includes a pressure sensing guidewire. In some embodiments, tracking the intravascular device within the radiographic image includes tracking the intravascular device within the radiographic image. In some embodiments, the speed adjustment advice includes advice to increase the speed at which the intravascular device moves within the body lumen when the calculated movement speed is below the target movement speed. In some embodiments, the speed adjustment advice includes advice to reduce the speed at which the intravascular device moves within the body lumen when the calculated movement speed is higher than the target movement speed. In some embodiments, the speed adjustment advice includes advice to maintain a speed at which the intravascular device moves within the body lumen when the calculated movement speed matches the target movement speed. In some embodiments, calculating the movement velocity includes considering movement of the intravascular instrument through the body lumen in the Z-plane. In some embodiments, accounting for movement of the intravascular instrument through the body lumen in the Z plane is based on analysis of radiographic images obtained during biplane angiography. In some embodiments, accounting for movement of the intravascular instrument through the body lumen in the Z-plane is based on analysis of anatomical data related to the structure of the body lumen.

In one embodiment, a method is disclosed. The method comprises the following steps: receiving, by a medical processing unit in communication with a radiographic imaging source, a radiographic image of an intravascular device located within a body lumen, the radiographic image obtained by the radiographic imaging source; tracking, by the medical processing unit, the intravascular device in the radiographic image as the intravascular device is moved longitudinally within the body lumen; calculating, by the medical processing unit, a movement speed based on the tracking; comparing, by the medical processing unit, the calculated movement speed with a predefined target movement speed; generating, by the medical processing unit, a speed adjustment recommendation based on the comparison; and outputting, by the medical processing unit, the speed adjustment suggestion to a display for viewing by a user.

In some embodiments, the predefined target movement speed comprises a target range between 1 mm/s to 3 mm/s, inclusive. In some embodiments, the speed adjustment recommendation includes a graphical image configured to instruct a user to increase, decrease, or maintain the speed at which the intravascular device moves within the body lumen. In some embodiments, the speed adjustment advice includes textual instructions for increasing, decreasing, or maintaining the speed at which the intravascular device moves within the body lumen. In some embodiments, the speed adjustment recommendations include recommendations for repeating the pullback operation. In some embodiments, the intravascular device comprises an intravascular ultrasound (IVUS) catheter. In some embodiments, the intravascular device includes a pressure sensing guidewire. In some embodiments, calculating the movement velocity includes compensating for motion of the heartbeat.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory in nature and are intended to provide an understanding of the present disclosure, but are not intended to limit the scope of the disclosure. In this regard, other aspects, features and advantages of the present disclosure will be apparent to those skilled in the art from the following detailed description.

Drawings

Illustrative embodiments of the present disclosure will be described with reference to the accompanying drawings, in which:

fig. 1 is a diagrammatic perspective view of a vessel having a stenosis according to an embodiment of the present disclosure.

Figure 2 is a diagrammatic, partial cross-sectional perspective view of a portion of the vessel of figure 1 taken along section line 2-2 of figure 1.

Fig. 3 is a diagrammatic, partial cross-sectional perspective view of the vessel of fig. 1 and 2 with an instrument according to an embodiment of the present disclosure placed therein.

Fig. 4 is a diagrammatic schematic view of a system in accordance with an embodiment of the present disclosure.

Fig. 5A is a diagrammatic, schematic side view of an intravascular instrument according to an embodiment of the present disclosure.

Fig. 5B is a diagrammatic, schematic side view of an intravascular instrument according to an embodiment of the present disclosure.

Fig. 6 is a radiographic image of vasculature according to an embodiment of the disclosure.

Fig. 7A is a diagrammatic schematic view illustrating a speed adjustment recommendation for an intravascular device and a display of radiographic images according to an embodiment of the present disclosure.

Fig. 7B is a diagrammatic schematic view illustrating a speed adjustment recommendation for an intravascular device and a display of radiographic images according to an embodiment of the present disclosure.

Fig. 7C is a diagrammatic schematic view illustrating a speed adjustment recommendation for an intravascular instrument and a display of radiographic images according to an embodiment of the present disclosure.

FIG. 8A is a diagrammatic schematic view of a display showing speed adjustment suggestions in accordance with an embodiment of the present disclosure.

FIG. 8B is a diagrammatic schematic view of a display showing speed adjustment suggestions in accordance with an embodiment of the present disclosure.

Fig. 8C is a diagrammatic schematic view of a display showing speed adjustment suggestions in accordance with an embodiment of the present disclosure.

FIG. 8D is a diagrammatic schematic view of a display showing speed adjustment suggestions in accordance with an embodiment of the present disclosure.

Fig. 9A is an image of a display showing co-registration of in-tube data with radiographic images according to an embodiment of the present disclosure.

Fig. 9B is an image of the display showing co-registration of the in-tube data with the radiographic image according to an embodiment of the present disclosure.

Fig. 10 is a flow chart of a method according to an embodiment of the present disclosure.

Detailed Description

For the purposes of promoting an understanding of the principles of the disclosure, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the disclosure is thereby intended. Any alterations and further modifications in the described devices, systems, and methods, and any further applications of the principles of the disclosure as described herein, as would normally occur to one skilled in the art to which the disclosure relates, are fully contemplated and encompassed by the present disclosure. In particular, it has been fully contemplated that the features, components, and/or steps described with respect to one embodiment may be combined with the features, components, and/or steps described with respect to other embodiments of the present invention. Additionally, the dimensions provided herein are for specific examples, and it is contemplated that the concepts of the present disclosure can be implemented with different sizes, dimensions, and/or ratios. However, for the sake of brevity, multiple iterations of these combinations will not be described separately.

Referring to fig. 1 and 2, a vessel 100 having a stenosis is shown in accordance with an embodiment of the present disclosure. In this regard, fig. 1 is a diagrammatic perspective view of a vessel 100, and fig. 2 is a partial cross-sectional perspective view of a portion of the vessel 100 taken along section line 2-2 of fig. 1. Referring more particularly to fig. 1, a vessel 100 includes a proximal portion 102 and a distal portion 104. A lumen 106 extends along the length of the vessel 100 between the proximal and distal portions 102, 104. The lumen 106 is configured to allow fluid flow through the vessel. In some cases, vessel 100 is a systemic blood vessel. In some particular cases, vessel 100 is a coronary artery. In such cases, the lumen 106 is configured to facilitate blood flow through the vessel 100.

As shown, the vessel 100 includes a stenosis 108 between the proximal portion 102 and the distal portion 104. Stenosis 108 generally represents any blockage or other structural arrangement that results in restricting fluid flow through lumen 106 of vessel 100. Embodiments of the present disclosure are suitable for a variety of vascular applications, including, but not limited to, coronary, peripheral (including, but not limited to, lower limb, carotid, and neurovascular), renal, and/or venous. Where the vessel 100 is a blood vessel, the stenosis 108 may be the result of plaque build-up, including, but not limited to plaque components such as fibers, fibro-lipids (fibro-fat), necrotic cells, calcification (dense calcium), blood, fresh thrombus, and mature thrombus. In general, the composition of the stenosis will depend on the type of vessel being evaluated. It should be understood that the concepts of the present disclosure are applicable to virtually any type of vessel occlusion or other narrowing that results in a reduced fluid flow.

Referring more specifically to fig. 2, the lumen 106 of the vessel 100 has a diameter 110 proximal of the stenosis 108 and a diameter 112 distal of the stenosis 108. In some cases, diameters 110 and 112 are substantially equal to each other. In this regard, the diameters 110 and 112 are intended to represent healthy portions of the lumen 106, or at least healthier portions as compared to the stenosis 108. Accordingly, these healthier portions of the lumen 106 are shown as having a substantially constant cylindrical profile, and thus, the height or width of the lumen is referred to as the diameter. However, it should be understood that in many cases, these portions of the lumen 106 will also have plaque build-up, asymmetric contours, and/or other irregularities, but to a lesser extent than the stenosis 108, and thus will not have a cylindrical contour. In such cases, diameters 110 and 112 should be understood to represent relative sizes or cross-sectional areas of the lumens, and do not imply a circular cross-sectional profile.

As shown in fig. 2, stenosis 108 comprises a plaque buildup 114 that narrows the lumen 106 of vessel 100. In some cases, plaque buildup 114 may not have a uniform or symmetric profile, such that contrast assessment of such stenosis may not be reliable. In the illustrated embodiment, plaque buildup 114 includes an upper portion 116 and an opposing lower portion 118. The lower portion 118 has an increased thickness relative to the upper portion 116, which results in an asymmetric and non-uniform profile relative to the portions of the lumen proximal and distal to the stenosis 108. As shown, plaque buildup 114 reduces the available space for fluid flow through lumen 106. In particular, plaque buildup 114 reduces the cross-sectional area of lumen 106. At the narrowest point between the upper and lower portions 116, 118, the lumen 106 has a height 120, which represents a reduced size or cross-sectional area relative to the diameters 110 and 112 proximal and distal of the stenosis 108. It should be noted that stenosis 108, including plaque buildup 114, is exemplary in nature and should not be considered limiting in any way. In this regard, it should be understood that the stenosis 108 has other shapes and/or compositions that restrict fluid flow through the lumen 106 in other instances. Although the vessel 100 is shown in fig. 1 and 2 with a single stenosis 108, and the description of the embodiments below is primarily made in the context of a single stenosis, it should be understood that the devices, systems, and methods described herein have similar application to vessels with multiple stenotic regions.

Referring now to fig. 3, a vessel 100 is shown having instruments 130 and 132 according to embodiments of the present disclosure placed therein. In general, instruments 130 and 132 may include any form of device, instrument, or probe sized and shaped to be positioned within a vessel. In the illustrated embodiment, instrument 130 generally represents a guidewire and instrument 132 generally represents a catheter or guide catheter. In general, the instruments 130, 132 may include a flexible elongate member including a proximal portion and a distal portion. In this regard, the instrument 130 may extend through a central lumen of the instrument 132. However, in other embodiments, the instruments 130 and 132 may take other forms. In some embodiments, instruments 130 and 132 may take a similar form. For example, in some cases, both instruments 130 and 132 may include a guidewire. In other instances, both instruments 130 and 132 may include catheters. In another aspect, in some embodiments, such as the illustrated embodiment, instruments 130 and 132 may take different forms, with one instrument comprising a catheter and the other instrument comprising a guidewire. Further, in some cases, as shown in the embodiment shown in fig. 3, instruments 130 and 132 may be disposed coaxially with one another. In other cases, one of the instruments may extend through an eccentric lumen of the other instrument. In other cases, instruments 130 and 132 may extend side-by-side. In some particular embodiments, at least one of the instruments includes a rapid exchange device, such as a rapid exchange catheter. In such embodiments, the other instrument may include a dual guidewire or other device configured to facilitate the introduction and removal of a rapid exchange device. Further, in other cases, a single instrument may be utilized in place of the two separate instruments 130 and 132. In some embodiments, a single instrument may combine multiple functions (e.g., data acquisition) of the two instruments 130 and 132.

The instrument 130 may be configured to obtain diagnostic information about the vessel 100. For purposes of this disclosure, the term "diagnostic information" will be used, although in some instances diagnostic information may include diagnostic data, biological information, biological data, cardiovascular information, cardiovascular data, and/or other information or data. Diagnostic information may be collected continuously about every 0.01 second, about every 0.1 second, about every 0.25 seconds, about every 0.5 seconds, about once per second, about once every two seconds, about once every 5 seconds, about once every 10 seconds, about once every heartbeat, and/or other time frames. It is also contemplated that diagnostic information may be collected in response to a trigger, in response to a command, or in response to a request. The diagnostic information may include one or more of the following: pressure, flow (velocity), images (including images obtained using ultrasound (e.g., IVUS), OCT, thermal, and/or other imaging techniques), temperature, heart rate, electrical activity, and/or combinations thereof.

Accordingly, the instrument 130 may include one or more sensors, transducers, and/or other monitoring elements configured to obtain diagnostic information about the vessel. One or more sensors, transducers, and/or other monitoring elements may be positioned adjacent a distal portion of instrument 130. Sensors, transducers and/or other monitoring elements may be described with reference to aspects of their embodiments. For example, the pressure sensor may include a sensor configured to measure pressure. In another example, the aortic transducer may comprise a transducer located in the aorta and/or interacting with diagnostic information about the aorta. In some cases, a transducer such as an aortic transducer may be positioned outside the patient and/or a proximal portion of the instrument 130. For example, the transducer may be in fluid communication with a pressure sensing location located at a distal portion of the instrument 130 positioned within the patient. The pressure at the pressure sensing location within the patient may be measured by the aortic transducer based on the fluid communication. In some cases, one or more sensors, transducers, and/or other monitoring elements may be positioned less than 30 centimeters, less than 10 centimeters, less than 5 centimeters, less than 3 centimeters, less than 2 centimeters, and/or less than 1 centimeter from the distal tip 134 of the instrument 130. In an embodiment, at least one of the one or more sensors, transducers, and/or other monitoring elements may be positioned at the distal tip of the instrument 130.

The instrument 130 may include at least one element configured to monitor pressure within the vessel 100. The pressure monitoring element may take the form of a piezoresistive pressure sensor, a piezoelectric pressure sensor, a capacitive pressure sensor, an electromagnetic pressure sensor, a fluid column (in communication with a fluid column sensor that is separate from and/or positioned at a portion of the instrument proximal to the fluid column), an optical pressure sensor, and/or combinations thereof. In some cases, one or more features of the pressure monitoring element may be implemented as a solid state component manufactured using semiconductor and/or other suitable manufacturing techniques. Examples of commercially available guidewire products that include suitable pressure monitoring elements include, but are not limited to, PrimeWire, available from Volcano corporationPressure guide wire, PrimePressure guide wire and ComboXT pressure and flow guide wires, and pressure wire Certus guide wires and pressure wire Aeris guide wires available from st. The instrument 130 may be sized so that it can be positioned through the stenosis 108 without significantly affecting fluid flow through the stenosis, which may affect the distal pressure reading. Accordingly, in some instances, the instrument 130 may have an outer diameter of 0.018 "or less. In some embodiments, the instrument 130 may have an outer diameter of 0.014 "or less.

The instrument 132 may also be configured to obtain diagnostic information about the vessel 100. In some cases, instrument 132 may be configured to obtain the same diagnostic information as instrument 130. In further instances, instrument 132 may be configured to obtain different diagnostic information than instrument 130, which may include additional diagnostic information, less diagnostic information, and/or alternative diagnostic information. Diagnostic information may be collected continuously about every 0.01 second, about every 0.1 second, about every 0.25 seconds, about every 0.5 seconds, about once per second, about once every two seconds, about once every 5 seconds, about once every 10 seconds, about once every heartbeat, and/or other time frames. It is also contemplated that diagnostic information may be collected in response to a trigger, in response to a command, and/or in response to a request. The diagnostic information obtained by instrument 132 may include one or more of pressure, flow (velocity), images (including images obtained using ultrasound (e.g., IVUS), OCT, thermal, and/or other imaging techniques), temperature, or a combination thereof.

The instrument 132 may include one or more sensors, transducers, and/or other monitoring elements configured to obtain this diagnostic information. In one embodiment, one or more sensors, transducers, and/or other monitoring elements may be positioned adjacent a distal portion of the instrument 132. Sensors, transducers and/or other monitoring elements may be described with reference to aspects of their embodiments. For example, the pressure sensor may include a sensor configured to measure pressure. In another example, the aortic transducer may comprise a transducer located in the aorta and/or interacting with diagnostic information about the aorta. In some cases, a transducer, such as an aortic transducer, may be positioned outside the patient and/or at a proximal portion of the instrument 130. For example, the transducer may be in fluid communication with a pressure sensing location located at a distal portion of the instrument 132 positioned within the patient. The pressure at the pressure sensing location within the patient may be measured by the aortic transducer based on the fluid communication. One or more sensors, transducers, and/or other monitoring elements may be positioned less than 30 centimeters, less than 10 centimeters, less than 5 centimeters, less than 3 centimeters, less than 2 centimeters, and/or less than 1 centimeter from the distal tip 136 of the instrument 132. In some cases, at least one of the one or more sensors, transducers, and/or other monitoring elements may be positioned at the distal tip of the instrument 132.

Similar to instrument 130, instrument 132 may also include at least one element configured to monitor pressure within vessel 100. The pressure monitoring element may take the form of a piezoresistive pressure sensor, a piezoelectric pressure sensor, a capacitive pressure sensor, an electromagnetic pressure sensor, a fluid column (in communication with a fluid column sensor that is separate from and/or located at a portion of the instrument proximal to the fluid column), an optical pressure sensor, and/or combinations thereof. In some cases, one or more features of the pressure monitoring element may be implemented as a solid state component manufactured using semiconductor and/or other suitable manufacturing techniques. In some embodiments, a miller catheter may be used. Currently available catheter products that can be used with one or more of the Xper Flex cardiac physiology monitoring system of philips, the Mac-Lab XT and XTi hemodynamic recording system of GE, AXIOM Sensis XP VC11 of siemens, horizons Cardiology Hemo of mechenson, and horizons XVu hemodynamic monitoring system of Mennen, and that include pressure monitoring elements, may be used in some instances for the instrument 132.

According to aspects of the present disclosure, at least one of the instruments 130 and 132 may be configured to monitor pressure within the vessel 100 distal to the stenosis 108 (e.g., blood pressure) and at least one of the instruments 130 and 132 may be configured to monitor pressure within the vessel proximal to the stenosis. In this regard, the instruments 130, 132 may be sized and shaped to allow positioning of at least one element configured to monitor pressure within the vessel 100 to be positioned appropriately proximal and/or distal of the stenosis 108 based on the configuration of the device. Fig. 3 shows a location 138 suitable for measuring pressure distal to the stenosis 108. In some cases, the location 138 may be a distance of less than 5 centimeters, less than 3 centimeters, less than 2 centimeters, less than 1 centimeter, less than 5 millimeters, and/or less than 2.5 millimeters from the distal end of the stenosis 108 (shown in fig. 2).

FIG. 3 also shows a number of suitable locations for measuring pressure proximal of the stenosis 108. Locations 140, 142, 144, 146, and 148 each represent locations that may be suitable for monitoring pressure proximal to a stenosis under certain circumstances. Locations 140, 142, 144, 146, and 148 are positioned at different distances from the proximal end of stenosis 108, ranging from greater than 20 centimeters down to about 5 millimeters or less. The proximal pressure measurement may be spaced apart from the proximal end of the stenosis. Thus, in some cases, proximal pressure measurements may be taken at a distance from the proximal end of the stenosis that is equal to or greater than the inner diameter of the vessel lumen. In the case of coronary pressure measurements, proximal pressure measurements may be made at locations proximal to the stenosis and distal to the main artery, within the proximal portion of the vessel. However, in certain particular cases of coronary pressure measurements, the proximal pressure measurement may be taken from a location within the aorta. In this case, the obtained pressure data may be referred to as aortic pressure data. In other cases, proximal pressure measurements may be taken at the root or ostium of the coronary artery.

Referring now to fig. 4, shown therein is a system 150 in accordance with an embodiment of the present disclosure. In this regard, fig. 4 is a diagrammatic, schematic view of a system 150. As shown, the system 150 includes an instrument 152. In this regard, in certain instances, instrument 152 is suitable for use as at least one of instruments 130 and 132 discussed above. Accordingly, in some instances, instrument 152 includes features similar to those discussed above with respect to one or both of instruments 130 and 132. In the illustrated embodiment, the instrument 152 is a guidewire having a distal portion 154 and a housing 156 positioned adjacent the distal portion. In this regard, the housing 156 is spaced about 3 centimeters from the distal tip of the instrument 152. The housing 156 is configured to house one or more sensors, transducers, and/or other monitoring elements configured to obtain diagnostic information about the vessel. In the illustrated embodiment, the housing 156 contains at least one pressure sensor configured to monitor the pressure within the lumen in which the instrument 152 is positioned. A shaft 158 extends proximally from the housing 156. A torque device 160 is positioned and coupled to a proximal portion of the shaft 158. Proximal portion 162 of instrument 152 is coupled to connector 164. A cable 166 extends from connector 164 to a connector 168. In some cases, the connector 168 is configured to plug into the interface 170. In this regard, in some cases, interface 170 is a Patient Interface Module (PIM). In some cases, cable 166 may be replaced with a wireless connection. In this regard, it should be understood that various communication paths between the instrument 152 and the interface 170 may be utilized, including physical connections (including electrical, optical, and/or fluid connections), wireless connections, and/or combinations thereof.

Interface 170 is communicatively coupled to computing device 172 via connection 174. Computing device 172 generally represents any device suitable for performing the processing and analysis techniques discussed in this disclosure. In some embodiments, computing device 172 includes a processor, random access memory, and a storage medium. In this regard, in some particular instances, the computing device 172 is programmed to perform the steps associated with the normalization, data acquisition, and data analysis described herein. Accordingly, it should be understood that any steps related to the standardization, data acquisition, data processing, instrument control, and/or other processing or control aspects of the present disclosure may be implemented by the computing device 172 using corresponding instructions stored on or within a non-transitory computer readable medium accessible to the computing device 172. In some cases, computing device 172 is a console device. In some particular cases, computing device 172 is similar to an s5 imaging system or an s5i imaging system, which are available from Volcano corporation. In some cases, the computing device 172 is portable (e.g., handheld, on a cart, etc.). In some cases, all or a portion of computing device 172 may be implemented as a bedside controller, such that one or more of the process steps described herein may be performed by a processing component of the bedside controller. An exemplary Bedside Controller is described in U.S. provisional application No.62/049,265 entitled "Bedside Controller for assistance of Vessels and Associated Devices, Systems, and Methods" filed on 11.9.2014 (for evaluating Vessels and related apparatus, Systems and Methods), moreover, it should be understood that in some instances, the computing device 172 comprises a plurality of computing devices and/or virtual computing devices. Any division and/or combination of processing and/or control aspects described below across multiple computing devices and/or virtual computing devices is within the scope of the present disclosure.

Together, connector 164, cable 166, connector 168, interface 170, and connection 174 facilitate communication between one or more sensors, transducers, and/or other monitoring elements of instrument 152 and computing device 172. However, this communication path is exemplary in nature and should not be considered limiting in any way. In this regard, it should be understood that any communication path between the instrument 152 and the computing device 172 may be utilized, including physical connections (including electrical, optical, and/or fluid connections), wireless connections, and/or combinations thereof. In this regard, it should be understood that in some instances, the connection 174 is wireless. In some cases, connection 174 includes a communication link through a network (e.g., an intranet, the internet, a telecommunications network, and/or other network). In this regard, it should be understood that in some instances, the computing device 172 is located remotely from the operating area in which the instrument 152 is being used. Having the connection 174 comprise a connection over a network may facilitate communication between the instrument 152 and the remote computing device 172, whether the computing device is in an adjacent room, adjacent building, or in a different state/country. Further, it should be understood that in some instances, the communication path between the instrument 152 and the computing device 172 is a secure connection. Still further, it should be understood that in some instances, data communicated over one or more portions of the communication path between the instrument 152 and the computing device 172 is encrypted.

The system 150 also includes an instrument 175. In this regard, in some instances, instrument 175 is suitable for use as at least one of instruments 130 and 132 described above. Accordingly, in some instances, instrument 175 includes features similar to those discussed above with respect to one or both of instruments 130 and 132. In the illustrated embodiment, the instrument 175 is a catheter-type device. In this regard, the instrument 175 includes one or more sensors, transducers, and/or other monitoring elements adjacent a distal portion of the instrument 175 that are configured to obtain diagnostic information about the vessel. In the illustrated embodiment, the instrument 175 includes a pressure sensor configured to monitor the pressure within the lumen in which the instrument 175 is positioned. The instrument 175 communicates with the interface 176 via a connection 177. In some cases, interface 176 is a hemodynamic monitoring system or other control device, such as AXIOM Sensis, honeynen Horizon XVu, and Philips Xper IM Physiomonitoring 5. In one particular embodiment, instrument 175 is a pressure sensing catheter that includes a fluid column extending along its length. In such embodiments, interface 176 includes a hemostasis valve fluidly coupled to the fluid column of the catheter, a manifold fluidly coupled to the hemostasis valve, and a conduit suitably extending between the components to fluidly couple the components. In this regard, the fluid column of the conduit is in fluid communication with the pressure sensor via valves, manifolds, and conduits. In some cases, the pressure sensor is part of the interface 176. In other cases, the pressure sensor is a separate component positioned between the instrument 175 and the interface 176. Interface 176 is communicatively coupled to computing device 172 via connection 178.

Computing device 172 is communicatively coupled to display device 180 via wired or wireless connection 182. In some embodiments, display device 180 is a component of computing device 172, while in other embodiments, display device 180 is different from computing device 172. In some embodiments, the display device 180 is implemented as a bedside controller with a touch screen display, as described in, for example, U.S. provisional application No.62/049,265 entitled "Bedside Controller for Assessment of Vessels and Associated Devices, Systems, and Methods," filed on 11.9.2014, the computing device 172 may generate a screen display including data collected by the instruments 152 and 175 and other instruments, a calculated quantity based on the collected data, a visual representation of the vessel in which the data is collected, and a visual representation based on the collected data and the calculated quantity.

The computing device 172 is communicatively coupled to the radiographic imaging unit 186. For example, data obtained by radiographic imaging unit 186 may be sent to computing device 172 and/or received by computing device 172, either directly or indirectly, e.g., via wired or wireless connection 184. The radiographic imaging unit 186 can obtain diagnostic information of the patient's vasculature and can communicate such diagnostic information to the computing device 172. The unit 186 may be referred to as an external imaging unit in some embodiments because it acquires imaging data of a body lumen inside the body while positioned outside the body. In various embodiments, the diagnostic information obtained by the external imaging unit 186 may include obtained from externally obtained angiographic images, X-ray images, CT images, PET images, MRI images, SPECT images, fluoroscopic images, radiographic images, combinations thereof, and/or other imaging sources that delineate extraluminal portions of the patient's vasculature in two or three dimensions. For example, the angiographic image may be a single, still radiographic image of the patient's vasculature and/or one or more intravascular devices located within the vasculature. For example, the fluoroscopic images may be multiple, moving radiographic images of the vasculature and/or one or more intravascular devices located within the vasculature. In some cases, diagnostic information and/or data obtained by the instruments 130, 132, 152, and/or 175 may be associated or registered with diagnostic information obtained by the radiographic imaging unit 186 (e.g., angiographic images and/or other two-dimensional or three-dimensional images of the patient's vasculature). In some embodiments, radiographic imaging unit 186 obtains radiographic images after contrast media has been delivered into the vessels and/or other lumens. In other embodiments, the radiographic imaging unit 186 obtains radiographic images without contrast agent within the vessels and/or other lumens.

Computing device 172 may additionally be communicatively coupled to a user interface device. The user interface device allows a user to interact with the screen display on the display device 180. For example, a user may provide user input to modify all or a portion of a screen display using a user interface device. In some embodiments, the user interface device is a separate component from the display device 180. In other embodiments, the user interface device is part of the display device 180. For example, the user interface device may be implemented as a Bedside Controller with a touch screen display, such as described in U.S. provisional application No.62/049,265 entitled "Bedside Controller for Assessment of Vessels and Associated Devices, Systems, and Methods", filed on 11.9.2014, which is hereby incorporated by reference in its entirety.

Similar to the connection between the instrument 152 and the computing device 172, the interface 176 and the connections 177 and 178 facilitate communication between one or more sensors, transducers, and/or other monitoring elements of the instrument 175 and the computing device 172. However, this communication path is exemplary in nature and should not be considered limiting in any way. In this regard, it should be understood that any communication path between the instrument 175 and the computing device 172 may be utilized, including physical connections (including electrical, optical, and/or fluid connections), wireless connections, and/or combinations thereof. In this regard, it should be understood that the connection 178 is wireless in some instances. In some cases, connection 178 includes a communication link through a network (e.g., an intranet, the internet, a telecommunications network, and/or other network). In this regard, it should be understood that in some instances, the computing device 172 is located remotely from the operating area in which the instrument 175 is being used. Having the connection 178 include a connection over a network may facilitate communication between the instrument 175 and the remote computing device 172 regardless of whether the computing device is in an adjacent room, adjacent building, or in a different state/country. Further, it should be understood that in some instances, the communication path between the instrument 175 and the computing device 172 is a secure connection. Still further, it should be understood that in some instances, data communicated over one or more portions of the communication path between the instrument 175 and the computing device 172 is encrypted.

It should be understood that in other embodiments of the present disclosure, one or more components of the system 150 are not included, are implemented in a different arrangement/order, and/or are replaced by alternative devices/mechanisms. For example, in some cases, system 150 does not include interface 170 and/or interface 176. In this case, connector 168 (or other similar connector in communication with instrument 152 or instrument 175) may be inserted into a port associated with computing device 172. Alternatively, the instruments 152, 175 may be in wireless communication with the computing device 172. In general, the communication path between one or both of the instruments 152, 175 and the computing device 172 may have no intermediate nodes (i.e., a direct connection), one intermediate node between the instrument and the computing device, or multiple intermediate nodes between the instrument and the computing device.

It should be understood that one or more of the instruments 130, 132, 150, 152 may be a guidewire, a guiding catheter, a catheter, or any other suitable endoluminal device. In this regard, the instruments 130, 132, 150, 152 include flexible elongate members that form the body of the endoluminal instrument. In use, the proximal portion of the flexible elongate member is positioned outside the patient's body. One, two, three, four, or more sensors are coupled to a distal portion of the flexible elongate member and configured to obtain any suitable data associated with the body lumen when positioned therein. The data may include one or more of pressure, flow (velocity), images (including images obtained using ultrasound (e.g., IVUS), OCT, thermal, and/or other imaging techniques), temperature, or a combination thereof. One or more of instruments 130, 132, 150, 152 may be an Intracardiac (ICE) echocardiographic catheter and/or a transesophageal echocardiographic (TEE) probe. The instruments 130, 132, 150, 152 are sized and shaped, structurally arranged, and/or otherwise configured to be positioned within any suitable body lumen of a patient. Body lumens may represent natural and artificial fluid-filled or fluid-surrounded structures. The body lumen may be a blood vessel, such as an artery or vein of a patient's vascular system, including the heart vasculature, peripheral vasculature, nerve vasculature, renal vasculature, and/or any other suitable lumen within the body. For example, the instruments 130, 132, 150, 152 may be used to examine any number of anatomical locations and tissue types, including but not limited to: organs, including liver, heart, kidney, gall bladder, pancreas, lung; a pipeline; a bowel; nervous system structures including the brain, dural sac, spinal cord, and peripheral nerves; the urinary tract; as well as valves in the blood, chambers or other parts of the heart, and/or other systems of the body. In addition to natural structures, the instruments 130, 132, 150, 152 may be used to examine artificial structures such as, but not limited to, heart valves, stents, shunts, filters, and other devices.

Referring now to fig. 5A and 5B, a diagrammatic, schematic side view of an intravascular instrument 202 is shown. Fig. 5A and 5B illustrate a distal portion of an intravascular instrument 202. It should be understood that, in use, the intravascular device 202 may be positioned within a patient's vasculature. In one embodiment, the intravascular device 202 may be a component of the system 150 and/or may interact with a component of the system 150. In this regard, in certain instances, the intravascular device 202 may be adapted for use as at least one of the devices 130, 132, 152, and 175 discussed above. Accordingly, in some instances, the intravascular device 202 includes features similar to those discussed above with respect to one or more of the devices 130, 132, 152, and 175. In some cases, the intravascular device 202 may include a pressure sensing guidewire or catheter. In some cases, the intravascular device 202 may include an IVUS guidewire or catheter.

In the illustrated embodiment, the intravascular device 202 includes a sensor 210, a radiopaque region 214, and a non-radiopaque region 216. A pattern may be formed by radiopaque regions 214 and non-radiopaque regions 216. One possible pattern is shown in fig. 5A, while a different pattern is shown in fig. 5B. In fig. 5A, the entire area distal to the sensor 210 is radiopaque, while the entire area proximal to the sensor 210 is non-radiopaque. In fig. 5B, the entire area distal to the sensor 210 is radiopaque, while the area proximal to the sensor 210 has alternating radiopaque and non-radiopaque areas 214, 216.

The sensor 210 may be configured to obtain pressure data. In this regard, the sensor 210 may comprise a piezoresistive pressure sensor, a piezoelectric pressure sensor, a capacitive pressure sensor, an electromagnetic pressure sensor, a fluid column (separate from the intravascular device 202 and/or positioned at a portion of the intravascular device 202 proximal the fluid column), an optical pressure sensor, and/or combinations thereof.

In some cases, the sensor 210 may include an imaging component. The imaging assembly may include a transducer or a transducer array including a plurality of transducer elements or acoustic elements. The intravascular device 202 may transmit ultrasound energy from the transducer array. The ultrasound energy is reflected by tissue structures (e.g., walls of a body lumen such as a blood vessel) surrounding the transducer array, and ultrasound echo signals are received by the transducer array. The transducer array may include any suitable number of individual transducers between 1 acoustic element and 1000 acoustic elements, including values such as 2 acoustic elements, 4 acoustic elements, 36 acoustic elements, 64 acoustic elements, 128 acoustic elements, 500 acoustic elements, 812 acoustic elements, and/or other values greater or less. The transducer array may be a phased array. In some cases, the transducer elements of the array may be arranged in any suitable configuration, such as a linear array, a planar array, a curved array, a circumferential array, a circular array, a phased array, a matrix array, a one-dimensional (1D) array, a 1. x-dimensional array (e.g., a 1.5-dimensional array), or a two-dimensional (2D) array. The transducer array may be divided into segments, such as one or more rows and/or columns, which may be independently controlled and activated. The transducer array and/or individual transducers may be arranged to transmit and/or receive ultrasound energy at an oblique angle relative to a longitudinal axis of the intravascular instrument 202. The transducer may be a Piezoelectric Micromachined Ultrasonic Transducer (PMUT), a Capacitive Micromachined Ultrasonic Transducer (CMUT), a single crystal, lead zirconate titanate (PZT), a PZT composite, other suitable transducer types, and/or combinations thereof. An exemplary capacitive micromachined ultrasonic transducer (cMUT) is disclosed, for example, in U.S. patent application No.14/812,792 entitled "Ultrasound Imaging Apparatus, Interface Architecture, and Method of Manufacturing" filed on 29.7.2015, which is incorporated herein by reference in its entirety. Depending on the transducer material, the fabrication process of the transducer may include dicing, slitting, grinding, sputtering, wafer techniques (e.g., SMA, sacrificial layer deposition), other suitable processes, and/or combinations thereof.

The intravascular device 202 may be used to collect diagnostic information from within the vasculature of a patient, such as within the aorta and/or coronary arteries. In this regard, one or more sensors of the intravascular instrument 202 may collect pressure data, flow (velocity) data, images (including images obtained using ultrasound (e.g., IVUS), OCT, thermal, and/or other imaging techniques), temperature data, or a combination thereof. In some cases, the intravascular device 202 may be used to collect pressure data that is used to calculate pressure ratios, FFR values, and/or iFR (instantaneous wave-free ratio) values. Exemplary embodiments of determining a diagnostic window within a patient's heartbeat cycle and calculating an iFR value based on pressure measurements obtained within the diagnostic window are described in U.S. patent No.9,339,348, which is incorporated herein by reference in its entirety. Thus, the intravascular device 202 may be disposed within a vessel having a stenosis such that the intravascular device 202 may measure a pressure (Pd) distal to the stenosis, while another intravascular device may measure a pressure (Pa) proximal to the stenosis. In this regard, the intravascular device 202 may be positioned within the vessel such that the sensor 210 is distal of the stenosis.

During acquisition of diagnostic information, the intravascular device 202 may be moved longitudinally through the vasculature of the patient. In some cases, such movement may be part of a pullback operation (e.g., movement from a distal location within the vessel to a proximal location within the vessel). In other instances, such movement may include advancing the intravascular device 202 through the vasculature (e.g., movement from a proximal location within the vessel to a distal location within the vessel). The speed of movement may be manually controlled by a user, e.g. a physician, by acting on a proximal portion of the intravascular device that is disposed outside the patient's body. While existing electromechanical pullback devices may control the movement of the instrument 202 through the vessel, they are not preferred by users because they undesirably lengthen the operation by having to be mounted and connected to the instrument 202. As a result, if the user is required to use the pullback device, valuable intraluminal information may sometimes not be available to the user using the instrument 202. Users would prefer to allow simpler and faster workflow by manual, user-controlled withdrawal or advancement of the instrument 202 through a body lumen.

The speed at which the intravascular device 202 moves through the vasculature may affect the quality of the diagnostic information obtained and may affect the efficiency of the intravascular procedure. Because the operator is controlling the movement of the instrument 202, it may be difficult to achieve the correct speed. For example, if the intravascular device 202 moves too quickly, the diagnostic information may be distorted. Moving the intravascular device 202 too quickly may also result in a lack of diagnostic information for certain portions of the vasculature, such as those portions that are bypassed before diagnostic information can be obtained. Moving the intravascular device 202 too quickly may reduce the accuracy of co-registration when co-registering the diagnostic information obtained within the vessel with externally obtained radiographic images. On the other hand, moving the intravascular instrument 202 too slowly may only prolong the intravascular procedure without improving the quality of the obtained diagnostic information or improving the accuracy of the co-registration.

Thus, the target moving speed can be established. The target movement speed may be established by a user or may be automatically determined by a medical processing unit (e.g., computing device 172) in communication with the intravascular device 202. The target moving speed may be a moving speed at which accurate diagnostic information can be obtained and/or a moving speed at which the in-tube data can be accurately co-registered with the one or more radiographic images. The medical processing unit may determine the target movement velocity based on an analysis of the movement velocities of past data acquisitions and the success of such data acquisitions. For example, when the medical processing unit determines that data acquisition performed at a movement speed of 1 cm/sec is unsuccessful, the medical processing unit may establish a target movement speed of less than 1 cm/sec. The success of the data acquisition may be determined by the user, e.g., by the user indicating approval or disapproval of the medical processing unit, and/or may be determined by the medical processing unit itself, e.g., by determining that no diagnostic information has been obtained for certain portions of the vasculature or by determining that the intravascular procedure is repeated due to poor data quality. In this regard, the medical processing unit may store information indicating the speed of movement and success or failure of past intratubular operations, either locally or remotely.

The target movement speed may be a discrete value, such as 2 mm/sec, or may include a range of acceptable values, such as between 1 mm/sec and 3 mm/sec, inclusive. In this regard, the target movement speed may be any discrete value or range of values between 0.5 mm/sec and 10 mm/sec, inclusive. In some cases, the target movement speed may be any discrete value or range of values between 1 mm/sec and 5 mm/sec, inclusive. In some cases, the target movement speed may be any discrete value or range of values between 1 mm/sec and 3 mm/sec, inclusive. Although several exemplary discrete values and ranges are provided above, the target movement speed may in some cases be any suitable value or range of values, including values and ranges outside of the exemplary values and ranges described above. As described in more detail below, establishment of the target speed may enable the medical processing unit to provide guidance to the user in the form of speed adjustment recommendations.

Turning now to fig. 6, an angiographic image 300 is shown. The angiographic image 300 may have been obtained by a radiographic imaging source (e.g., the radiographic unit 186). As described above, the radiographic imaging source may be in communication with a medical processing unit (e.g., computing device 172). An angiographic image 300 may be obtained while the contrast agent fills the vasculature, and the location of various vessels (e.g., coronary arteries) may be delineated accordingly. In this regard, as described in more detail below, the angiographic image 300 may be used as a roadmap for calculating the speed of movement of the intravascular instrument and for co-registering the intravascular data with the radiographic image, e.g., as shown in fig. 9A and 9B.

Turning now to fig. 7A-7C, illustrated therein are diagrammatic, schematic diagrams of a display 400 showing a speed adjustment recommendation and radiographic images of an intravascular instrument according to an embodiment of the present disclosure. The radiographic images shown in fig. 7A to 7C are fluoroscopic images in the case where no contrast agent or at least very little contrast agent is present in the vasculature. The intravascular device 402 is visible in the radiographic image. Fig. 7A-7C depict different positions of the intravascular device 402 as it moves through the vessel, for example, during an intravascular procedure such as a pullback procedure.

In an embodiment, the intravascular device 402 may include and/or may interact with elements of the system 150. In this regard, in certain instances, the intravascular device 402 may be adapted for use as at least one of the devices 130, 132, 152, 175, or 202 discussed above. Accordingly, in some instances, the intravascular device 402 includes features similar to those discussed above with respect to one or more of the devices 130, 132, 152, 175, or 202. In some cases, the intravascular device 402 can include a pressure sensing guidewire or catheter. In some cases, the intravascular device 402 can include an IVUS guidewire or catheter.

The intravascular device 402 can include one or more radiopaque regions 414 and one or more non-radiopaque regions 416. The particular pattern formed by the radiopaque regions 414 and the non-radiopaque regions 416 may allow a medical processing unit (e.g., computing device 172) to detect and/or track the intravascular device 402 within the radiographic image. For example, the medical processing unit may analyze radiographic imaging data received from a radiographic imaging unit (e.g., radiographic imaging unit 186) for a characteristic pattern that may identify the in-tube instrument 402. In this regard, tracking the intravascular instrument 402 can include tracking the radiopaque region 414 and/or tracking a pattern. The intravascular device 402 may be tracked continuously every millisecond, every hundredth of a second, every tenth of a second, every 0.25 seconds, every second, the intravascular device 402 may be tracked on some other schedule, the intravascular device 402 may be tracked in response to a trigger such as a heartbeat or data acquisition event, or the intravascular device 402 may be tracked according to any combination of the preceding. The radiopaque region 414 may be a radiopaque marker or a sensor of the instrument 402. In some cases, the processor may be configured to distinguish between the radiopaque markers and the sensors, identifying the location of the sensors to locate the location within the vessel where the intravascular data was obtained in a given time or frame of the radiographic image stream. In some cases, the processor identifies the location of the sensor in the vessel using a pattern of radiopaque markers or a known arrangement of radiopaque markers and sensors.

In some cases, the pattern formed by the radiopaque regions 414 and the non-radiopaque regions 416 may further allow the medical processing unit to determine the location of the data acquisition elements (e.g., pressure sensors, ultrasound transducers, or transducer arrays, etc.) of the intravascular device 402. The position of the data acquisition element may be used to co-register the intravascular data with a radiographic image (e.g., an angiographic image). As used herein, co-registration of intravascular data with a radiographic image refers to displaying the intravascular data adjacent to and/or superimposed on the radiographic image along with an indication of the location on the radiographic image, which is indicative of the location within the vasculature from which the intravascular data was obtained.

The processor may co-register the position of the instrument 402, e.g., the data acquisition elements, in each frame of acquired radiographic data. In this manner, the processor identifies the location of the instrument 402 within the vessel for each frame of radiographic image. The processor determines the position of the instrument 402 by co-registration and receives the time at which the corresponding radiographic image frames are obtained from the radiographic image source. The processor uses the position of the instrument 402 and the corresponding image timestamp to calculate the velocity of movement of the instrument within the tube. Aspects of co-registration are described, for example, in U.S. patent No.7,930,014 and U.S. patent No.8,298,147, which are incorporated herein by reference in their entirety.

The medical processing unit may calculate the speed of movement of the intravascular device 402 as the intravascular device 402 moves through the vasculature. The movement speed may be calculated based on tracking the in-tube instrument 402. For example, by tracking the intravascular device 402, the medical processing unit can determine how far the intravascular device has moved within a certain period of time. If the intravascular device moves 2 millimeters in one second, the speed of movement of the intravascular device 402 is 2 millimeters/second. The medical processing unit may calculate the movement velocity continuously every millisecond, every hundredth of a second, every tenth of a second, every 0.25 seconds, every second, may calculate the movement velocity after some other time has elapsed, may calculate the movement velocity in response to a trigger such as a heartbeat or a data acquisition event, or may calculate the movement velocity in response to any combination of the preceding. In some cases, the medical processing unit may calculate a movement speed (e.g., 30 frames per second or other suitable amount) for each frame of radiographic image data. The calculated movement speed may reflect a current speed, an average speed, a pattern speed, or any combination of the preceding. In some embodiments, the speed of the intravascular device 402 can be the speed of the sensor.

As described above, the calculation of the movement speed may be based on tracking the intravascular instrument 402 in a radiographic image or images from the image stream. In general, movement of the intravascular device 402 in the radiographic image represents movement of the intravascular device 402 in the vasculature. However, it is understood that in some cases, the radiographic image is two-dimensional. In this case, the radiographic image can depict movement in the X and Y planes, but cannot depict movement in the Z plane. The intravascular device 402 can be advanced through the three-dimensional vasculature and can be moved in X, Y and the Z-plane. To account for movement in the Z-plane, the medical processing unit may access transformation data, such as anatomical data, as described below. In other cases, for example, in biplane angiography, three-dimensional radiographic images may be obtained that allow the tracking of the intravascular instrument 402 in X, Y and the Z-plane within the radiographic images themselves. It should also be understood that the radiographic image may be magnified by a factor such that movement of a distance in the radiographic image is not equal to movement of the same distance within the vasculature, even with respect to movement purely in the X and Y planes. As described below, the medical processing unit may access the transformation data, e.g. scaling data, to take account of such magnification.

The medical processing unit may store the transformation data locally or remotely to allow the medical processing unit to infer movement within the vasculature from movement in the radiographic image. The conversion data may include scaling data, e.g., data indicative of a factor by which the radiographic image magnifies the vasculature. The transformation data may also include anatomical data, for example, data about the three-dimensional structure of the vasculature. Such anatomical data may be based on medical averages and/or may be based on patient-specific anatomical data. The anatomical data may be determined by the medical processing unit based on past operations and may be updated when a new operation is performed. Thus, calculating the movement velocity may include compensating for movement in the Z-plane and/or compensating for an amplification factor.

In some cases, the calculation of the movement velocity also takes into account anatomical motion, such as described in U.S. publication No.2010/0157041 and U.S. patent No.9,216,065, which are incorporated herein by reference in their entirety. Anatomical motion may include the patient's heartbeat, inflation and deflation of the patient's lungs, contraction or relaxation of one or more muscles, and the like. The movement due to anatomical motion may be counteracted so as not to bias the calculation of the speed of movement of the intravascular device 402 through the vasculature. In this regard, the medical processing unit may store, either locally or remotely, anatomical motion data identifying characteristics of various anatomical motions. The medical processing unit may identify and eliminate anatomical motion based on the anatomical motion data.

The calculated moving speed may be displayed on the display 400 as shown in fig. 7A to 7C. Although the moving speed is displayed adjacent to the radiographic image in fig. 7A to 7C, it is to be understood that the moving speed may be superimposed on the radiographic image in some cases, and may be superimposed in some cases in the vicinity or proximity of the in-tube apparatus 402 or the data acquisition element of the in-tube apparatus 402. The calculated moving speed displayed on the display 400 may reflect a current speed (as shown in fig. 7A to 7C), an average speed, a mode speed, or any combination thereof.

The medical processing unit may compare the calculated movement speed with a predefined target movement speed. The medical processing unit may then provide guidance to a user (e.g., a physician or operator) based on the comparison. For example, the medical processing unit may output guidance to the display 400 in the form of speed adjustment recommendations. The speed adjustment recommendations may include recommendations to accelerate, decelerate, maintain speed (as shown in fig. 7A-7C), repeat in-line operations (e.g., pullback operations), or any combination thereof. When the calculated moving speed is lower than the target moving speed, a suggestion of acceleration may be given. When the calculated moving speed is higher than the target moving speed, a recommendation of deceleration may be given. When the calculated moving speed matches the target moving speed, a suggestion to maintain the speed may be given. A recommendation to repeat an in-tube operation may be given when the data quality is below a predefined threshold, when the average velocity during or for some part of the in-tube operation is above or below a predefined threshold, or when the accuracy of the co-registration is below a predefined threshold, or any combination thereof. The medical processing unit may output the speed adjustment advice continuously every millisecond, every hundredth of a second, every tenth of a second, every 0.25 second, every second, may output the speed adjustment advice after some other time has elapsed, may output the speed adjustment advice in response to a trigger such as a heartbeat, a data acquisition event, or a comparison between a calculated movement speed and a target movement speed being completed, or may output the speed adjustment advice in response to any combination of the foregoing.

Such speed adjustment recommendations advantageously increase the likelihood that the intravascular instrument will be moved at the proper speed for intravascular data acquisition and co-registration of the intravascular data with the radiographic images. Thus, such guidance also advantageously increases efficiency by reducing the likelihood of repeating the in-tube procedure due to poor data and/or inaccurate co-registration. Such guidance advantageously helps to ensure that the in-tube operation is repeated as appropriate if the in-tube data acquisition and/or co-registration is unsuccessful.

The guidance may be output in the form of graphics, text, symbols, sound, tactile feedback, or any combination thereof. For example, fig. 8A-8D show diagrammatic, schematic views of display 500 depicting speed adjustment suggestions. In this regard, fig. 8A and 8B show two different graphics 525, an upward arrow and a rabbit, respectively, suggesting that the user increase the speed at which the intravascular device moves through the vasculature. In FIGS. 8A and 8B, the graphic 525 is accompanied by text 535 suggesting that the user "accelerate! ". Fig. 8C and 8D show two different graphics 525, a downward arrow and a turtle, respectively, suggesting that the user reduce the speed at which the intravascular device moves through the vasculature. In FIGS. 8C and 8D, the graphic 525 is accompanied by text 535 suggesting that the user "slow down! ".

In case the movement of the intravascular device is automatically controlled, the medical processing unit may or may not output the guidance to the display. In this regard, the medical processing unit may automatically adjust the speed of the intravascular instrument based on a comparison of the calculated movement speed and the target movement speed, such as by automatically adjusting the speed of the pullback device.

Turning now to fig. 9A, there is shown a pictorial illustration of a screen display 600 depicting co-registration of intratubular data 642 with a radiographic image 646. In fig. 9A, the intratubular data 642 includes tomographic IVUS images. The in-tube data 643 includes a longitudinal view of a vessel that includes a stack of tomographic IVUS images. In fig. 9A the radiographic image 646 includes an angiographic image. Angiographic images are used for co-registration because the presence of contrast agent within the vasculature allows for a better view of the location of the various vessels that make up the vasculature. A position marker 648 has been superimposed on the radiographic image 646. The position marker 648 represents the location at which the intratubular data 642 (in this case, the IVUS image) was obtained. Position markers 649 are also provided in the longitudinal display 643 to identify the position of the corresponding IVUS image. Since sufficient IVUS data is collected during the movement of the intravascular device through the vessel at the appropriate speed, IVUS data is provided in co-registration. The guidance described herein may advantageously allow a user to move an intravascular device at an appropriate speed.

Turning now to FIG. 9B, there is shown a diagrammatic schematic view of a display 650 depicting co-registration of the in-line data with a radiographic image 656. In fig. 9B, the intravascular data includes iFR values calculated from pressure measurements obtained from one or more pressure sensing instruments. In fig. 9B, the radiographic image 656 includes an angiographic image. Angiographic images are used for co-registration because the presence of contrast agent within the vasculature allows for a better view of the location of the individual vessels making up the vasculature. Indicia 657 represents the pressure drop attributable to the adjacent location of the vessel (e.g., change in iFR value). Marker 658 indicates the longitudinal extent of the vessel selected by the user. Overlay mark 659 provides the length of the vessel in the selected region (mark 658) and the change in iFR value in the selected length. The value 652 provides the iFR value at the Distal position of the vessel (iFR disk), the total change in iFR value in the two selected regions (iFR drop in Selection), and the Expected iFR value at the Distal position in the two selected regions due to treatment (e.g., stent placement) (Expected iFR disk). A plot 653 of the iFR values along the length of the vessel is also provided. Since sufficient pressure data is collected during movement of the intravascular device through the vessel at the appropriate speed, iFR data is provided in co-registration. The guidance described herein may advantageously allow a user to move an intravascular device at an appropriate speed. An indication 655 may be provided if insufficient intravascular data is obtained in a given section of the vessel, for example, due to the pressure sensing guidewire moving too quickly through the vessel.

Referring now to fig. 10, shown therein is a flow diagram of a method 700 in accordance with an embodiment of the present disclosure. Some portions of the method 700 may correspond to the techniques discussed above with reference to fig. 1-9B and may be performed using hardware and/or software components of the system 150, the intravascular device 202, the intravascular device 402, the radiographic imaging unit 186, the computing device 172, or a combination thereof. The method 700 begins at block 702, where a radiographic image of an intravascular device located within a body lumen is received by a medical processing unit in communication with a radiographic imaging source at block 702. The intravascular device may include an intravascular ultrasound (IVUS) guidewire or catheter. The intravascular device may include a pressure sensing guidewire or catheter. Radiographic images may be obtained from a radiographic imaging source. The method continues at block 704 where the medical processing unit tracks the intravascular device within the radiographic images as the intravascular device is moved longitudinally within the body lumen at block 704. Block 704 may include co-registration such that as the intravascular device moves within the body lumen, the location of the intravascular device is identified in the frame of the radiographic image. At block 706, the medical processing unit calculates a movement speed of the intravascular instrument based on the tracking. Calculating the movement velocity may include compensating for motion of the heartbeat. At block 708, the medical processing unit compares the calculated movement velocity to a predefined target movement velocity. The predefined target movement speed may include a target range between 1 mm/sec and 3 mm/sec, inclusive. The method continues at block 710 where the medical processing unit generates a speed adjustment recommendation based on the comparison at block 710. At block 712, the medical processing unit outputs the speed adjustment suggestions to the display for viewing by the user. The speed adjustment recommendation may include a graphical image configured to instruct a user to increase, decrease, or maintain a speed at which an intravascular device moves within a body lumen. The speed adjustment advice may include textual instructions to increase, decrease, or maintain the speed at which the intravascular device moves within the body lumen. The speed adjustment advice may include advice to repeat the pullback operation. Although not shown in fig. 10, the method 700 may further include additional steps consistent with the foregoing disclosure. Further, the method 700 may omit some of the steps shown in fig. 10, and/or perform the steps in a different order, without departing from the scope of the present disclosure.

Those skilled in the art will also recognize that the above-described apparatus, systems, and methods may be modified in various ways. Therefore, those of ordinary skill in the art will appreciate that the embodiments encompassed by the present disclosure are not limited to the specific exemplary embodiments described above. In this regard, while exemplary embodiments have been shown and described, various modifications, changes, and substitutions are contemplated in the foregoing disclosure. It will be appreciated that such variations may be made to the foregoing without departing from the scope of the present disclosure. Accordingly, it is appropriate that the appended claims be construed broadly and in a manner consistent with the disclosure.