# US RE45,534 E1 · Vascular image co-registration

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- Number: US RE45,534 E1
- Document ID: USRE45534E1
- Status: Granted
- Kind: E1
- Application number: 13/865,803
- Filed: 2013-04-18
- Granted: 2015-06-02
- Earliest claimed: 2005-01-11
- Assignees: Volcano Corporation
- Applicants: Volcano Corporation
- Inventors: Richard Scott Huennekens; Stephen M. Fry; Blair D. Walker; Jon D. Klingensmith; Nancy Perry Pool; Vincent J. Burgess; William R. Kanz
- Web page: https://patentgrep.com/patent/USRE45534E1

## CPC

- A61B 5/06: Devices, other than using radiation, for detecting or locating foreign bodies {; Determining position of diagnostic devices within or on the body of the patient}
- A61B 19/5244
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A system and method for providing a vascular image are disclosed wherein a single composite display simultaneously provides a first view of a patient including an angiogram image and a second view including an intravascular image rendered from information provided by an imaging probe mounted on a distal end of a flexible elongate member. A cursor, having a position derived from image information provided by a radiopaque marker proximate the imaging probe, is displayed within the angiogram image to correlate the position of the imaging probe to a presently displayed intravascular image and thus provide an easily discernable identification of a position within a patient corresponding to a currently displayed intravascular image. The resulting composite display simultaneously provides: an intravascular image that includes information about a vessel that is not available from an angiogram and a current location within a vessel of a source of intravascular image data from which the intravascular image is rendered.

## Claims

### Claim 1

A system for acquisition and co-registered display of intravascular information, comprising:
an imaging flexible elongate member having a proximal end and a distal end;
an imaging probe located near the distal end of the flexible elongate member, and configured to obtain information for generating an image of a vessel;
a radiopaque marker located near the imaging probe;
a first memory for storing angiogram image data;
a second memory for storing intravascular image data derived from information obtained by the imaging probe;
a third memory for storing radiopaque marker image data, distinct from the angiogram image data, the radiopaque marker image data being derived from information obtained from a fluoroscopic imaging device;
a display processor configured to retrieve and combine data from the first memory, the second memory and the third memory, and further configured to render a composite image including:
an enhanced radiological image derived from the angiogram image data comprising a superimposition of at least a portion of the angiogram data and the radiopaque marker image data and providing a location of the radiopaque marker based upon an actual location during active fluoroscopy and an estimated location during inactive fluoroscopy,
an intravascular image element corresponding to the intravascular image data, wherein the enhanced radiological image and the intravascular image element are displayed proximate each other; and
a cursor, displayed upon the enhanced radiological image, indicative of a location of the imaging probe while acquiring data for the intravascular image element presently displayed on the composite image, said cursor having a position that is based at least in part on third data derived from the radiopaque marker image data stored in the third memory;
wherein the display processor is further configured to calculate an error function based on a difference between the estimated location of the radiopaque marker and the actual location of the radiopaque marker and wherein the display processor further configured to utilize the error function to correct the estimated location of the radiopaque marker for the preceding period of inactive fluoroscopy.

### Claim 2 (depends on 1)

The system of claim 1 wherein the flexible elongate member is a catheter.

### Claim 3 (depends on 1)

The system of claim 1 wherein the imaging probe comprises an ultrasound device.

### Claim 4 (depends on 3)

The system of claim 3 wherein the ultrasound device is a side-firing intravascular ultrasound transducer assembly.

### Claim 5 (depends on 4)

The system of claim 4 wherein the side-firing intravascular ultrasound transducer assembly comprises an array of transducer elements.

### Claim 6 (depends on 5)

The system of claim 5 wherein the array of transducer elements are linearly arranged along a lengthwise axis of the flexible elongate member.

### Claim 7 (depends on 5)

The system of claim 5 wherein the array of transducer elements are curvilinearly arranged about a lengthwise axis of the flexible elongate member.

### Claim 8 (depends on 5)

The system of claim 5 wherein the array of transducer elements are circumferentially arranged about a lengthwise axis of the flexible elongate member.

### Claim 9 (depends on 3)

The system of claim 3 wherein the ultrasound device comprises a Doppler transducer.

### Claim 10 (depends on 9)

The system of claim 9 wherein the flexible elongate member comprises a guidewire.

### Claim 11 (depends on 1)

The system of claim 1 wherein the flexible elongate member is a guidewire and the imaging probe comprises a pressure sensor.

### Claim 12 (depends on 1)

The system of claim 1 wherein the radiopaque marker comprises a cylindrical marker band.

### Claim 13 (depends on 1)

The system of claim 1 wherein the radiopaque marker comprises at least one partially complete cylindrical marker band.

### Claim 14 (depends on 13)

The system of claim 13 wherein the radiopaque marker comprises two semi-cylindrical marker bands.

### Claim 15 (depends on 14)

The system of claim 14 wherein the two semi-cylindrical marker bands are skewed in relation to one another along a lengthwise axis of the flexible elongate member.

### Claim 16 (depends on 15)

The system of claim 15 wherein the display processor further comprises an orientation determination function for determining a relative orientation of the imaging probe within the vessel based upon at least a relative size and position of the two semi-cylindrical marker bands in relation to one another.

### Claim 17 (depends on 1)

The system of claim 1 wherein the third data is derived from user-specified points.

### Claim 18 (depends on 1)

The system of claim 1 wherein the third data is derived by automated processes that determine a position of the radiopaque marker within a field of view.

### Claim 19 (depends on 18)

The system of claim 18 wherein the automated processes utilize image pattern recognition to determine the position.

### Claim 20 (depends on 1)

The system of claim 1 wherein the third data is derived from a combination of manual user input and automated calculations.

### Claim 21 (depends on 20)

The system of claim 20 wherein the automated calculations include determination of a predicted path of the imaging probe.

### Claim 22 (depends on 1)

The system of claim 1 wherein the display processor further comprises a bookmark function enabling a user to designate particular images of interest in a stored set of images containing at least the intravascular image element.

### Claim 23 (depends on 1)

The system of claim 1 wherein the enhanced radiological image includes a calculated path of the imaging probe.

### Claim 24 (depends on 1)

The system of claim 1 wherein the display processor further comprises-a slider function associated with the cursor that enables a user to reposition the cursor to a point of interest on the enhanced radiological image through a user interface control, and in response displays a particular instance of the intravascular image element associated with the point of interest.

### Claim 25 (depends on 1)

The system of claim 1, wherein the estimated location is based at least in part on a calculated path of the imaging probe and wherein the calculated path is updated based on the error function that is calculated based on a difference between the estimated location of the radiopaque marker and the actual location of the radiopaque marker.

### Claim 26

A method for acquiring and displaying intravascular information in a system including an imaging flexible elongate member having a proximal end and a distal end, an imaging probe located near the distal end of the flexible elongate member, and configured to obtain information for generating an image of a vessel, and a radiopaque marker located near the imaging probe, the method comprising the steps of:
storing angiogram image data in a first memory;
storing intravascular image data derived from information obtained by the imaging probe in a second memory;
storing radiopaque marker image data, distinct from the angiogram image data, in a third memory, the radiopaque marker image data being derived from information obtained from a fluoroscopic imaging device;
combining, by a display processor, data retrieved from the first memory, the second memory and the third memory to render a composite image including:
an enhanced radiological image derived from the angiogram image data comprising a superimposition of at least a portion of the angiogram data and the radiopaque marker data and providing a location of the radiopaque marker based upon an actual location during active fluoroscopy and an estimated location during inactive fluoroscopy, and
an intravascular image element corresponding to the intravascular image data, wherein the enhanced radiological image and the intravascular image element are displayed proximate each other; and
displaying a cursor upon the enhanced radiological image, indicative of a location of the imaging probe while acquiring data for the intravascular image element presently displayed on the composite image, said cursor having a position that is based at least in part on third data derived from the radiopaque marker image data previously stored in the third memory;
wherein the estimated location is based on a calculated path of the imaging probe, and wherein an error function is calculated based on a difference between the estimated location of the radiopaque marker and the actual location of the radiopaque marker when active fluoroscopy is resumed after inactive fluoroscopy and wherein the error function is utilized to correct the calculated path.

### Claim 27 (depends on 26)

The method of claim 26 wherein the flexible elongate member is a catheter.

### Claim 28 (depends on 26)

The method of claim 26 wherein the imaging probe comprises an ultrasound device.

### Claim 29 (depends on 28)

The method of claim 28 wherein the ultrasound device comprises a Doppler transducer.

### Claim 30 (depends on 26)

The method of claim 26 wherein the flexible elongate member is a guidewire and the imaging probe comprises a pressure sensor.

### Claim 31 (depends on 26)

The method of claim 26 wherein the radiopaque marker comprises two semi-cylindrical marker bands that are skewed in relation to one another along a lengthwise axis of the flexible elongate member and wherein the method comprises determining an orientation of the imaging probe based upon at least a relative size and position of the two semi-cylindrical marker bands in relation to one another.

### Claim 32 (depends on 26)

The method of claim 26 wherein the third data is derived from user-specified points.

### Claim 33 (depends on 26)

The method of claim 26 wherein the third data is derived by automated processes that determine a position of the radiopaque marker within a field of view.

### Claim 34 (depends on 26)

The method of claim 26 wherein the third data is derived from a combination of manual user input and automated calculations.

### Claim 35 (depends on 34)

The method of claim 34 wherein the automated calculations determine a predicted path of the imaging probe.

### Claim 36 (depends on 26)

The method of claim 26 further comprising storing a user-designated set of particular images of interest in a stored set of images containing at least the intravascular image element.

### Claim 37 (depends on 26)

The method of claim 26 further comprising incorporating a calculated path of the imaging probe within the enhanced radiological image.

### Claim 38 (depends on 26)

The method of claim 26 further comprising providing a slider function associated with the cursor that enables a user to reposition the cursor to a point of interest on the enhanced radiological image through a user interface control, and in response display a particular instance of the intravascular image element associated with the point of interest.

### Claim 39 (depends on 26)

The method of claim 26, wherein the calculated path is calculated using a first multiplication coefficient if the imaging probe is being pulled through the vessel and a second multiplication coefficient if the imaging probe is being pushed through the vessel.

### Claim 40

A system for acquisition and co-registered display of intravascular information, comprising:
an imaging flexible elongate member having a proximal end and a distal end;
an imaging probe located near the distal end of the flexible elongate member, and configured to obtain information for generating an image of a vessel;
a radiopaque located near the imaging probe;
a first memory portion for storing angiogram image data;
a second memory portion for storing intravascular image data derived from information obtained by the imaging probe;
a third memory portion for storing radiopaque marker image data, the radiopaque marker image data being derived from information obtained from a fluoroscopic imaging device;
a display processor configured to retrieve and combine data from the first memory portion, the second memory portion and the third memory portion, and further configured to render a composite image including:
an enhanced radiological image derived from the angiogram image data comprising a superimposition of at least a portion of the angiogram data and the radiopaque marker image data and providing a location of the radiopaque marker based upon an actual location during active fluoroscopy and an estimated location during inactive fluoroscopy, wherein an error function is calculated based on a difference between the estimated location of the radiopaque marker and the actual location of the radiopaque marker when active fluoroscopy is resumed after inactive fluoroscopy and wherein the error function is utilized to correct the estimated location of the radiopaque marker for the preceding period of inactive fluoroscopy,
an intravascular image element corresponding to the intravascular image data, wherein the enhanced radiological image and the intravascular image element are displayed proximate each other; and
a cursor, displayed upon the enhanced radiological image, indicative of a location of the imaging probe while acquiring data for the intravascular image element presently displayed on the composite image, said cursor having a position that is based at least in part on third data derived from the radiopaque marker image data stored in the third memory portion.

### Claim 41 (depends on 40)

The method of claim 40, wherein the calculated path is calculated using a first multiplication coefficient if the imaging probe is being pulled through the vessel and a second multiplication coefficient if the imaging probe is being pushed through the vessel.

### Claim 42 (depends on 40)

The system of claim 40, wherein the imaging flexible elongate member is a catheter.

### Claim 43 (depends on 40)

The system of claim 40, wherein the imaging flexible elongate member is a guidewire.

### Claim 44 (depends on 40)

The system of claim 40, wherein the imaging probe includes an ultrasound transducer.

### Claim 45 (depends on 40)

The system of claim 40, wherein the imaging probe includes a pressure sensor.

### Claim 46

A system for acquisition and co-registered display of intravascular information, comprising:
a flexible elongate member having a proximal end and a distal end;
a diagnostic probe located near the distal end of the flexible elongate member, and configured to obtain information related to a vessel;
a radiopaque marker located near the diagnostic probe;
a first memory for storing angiogram image data;
a second memory for storing intravascular data derived from information obtained by the diagnostic probe;
a third memory for storing radiopaque marker image data, distinct from the angiogram image data, the radiopaque marker image data being derived from information obtained from a fluoroscopic imaging device;
a display processor configured to retrieve and combine data from the first memory, the second memory and the third memory, and further configured to render a composite image including:
an enhanced radiological image derived from the angiogram image data comprising a superimposition of at least a portion of the angiogram data and the radiopaque marker image data and providing a location of the radiopaque marker based upon an actual location during active fluoroscopy and an estimated location during inactive fluoroscopy,
an intravascular image element corresponding to the intravascular data, wherein the enhanced radiological image and the intravascular image element are displayed proximate each other; and
a cursor, displayed upon the enhanced radiological image, indicative of a location of the diagnostic probe while acquiring data for the intravascular image element presently displayed on the composite image, said cursor having a position that is based at least in part on third data derived from the radiopaque marker image data stored in the third memory;
wherein the display processor is further configured to calculate an error function based on a difference between the estimated location of the radiopaque marker and the actual location of the radiopaque marker and wherein the display processor further configured to utilize the error function to correct the estimated location of the radiopaque marker for the preceding period of inactive fluoroscopy.

### Claim 47 (depends on 46)

The system of claim 46 wherein the flexible elongate member is a catheter.

### Claim 48 (depends on 46)

The system of claim 46 wherein the diagnostic probe comprises an ultrasound device.

### Claim 49 (depends on 48)

The system of claim 48 wherein the ultrasound device is a side-firing intravascular ultrasound transducer assembly.

### Claim 50 (depends on 49)

The system of claim 49 wherein the side-firing intravascular ultrasound transducer assembly comprises an array of transducer elements.

### Claim 51 (depends on 50)

The system of claim 50 wherein the array of transducer elements are linearly arranged along a lengthwise axis of the flexible elongate member.

### Claim 52 (depends on 50)

The system of claim 50 wherein the array of transducer elements are curvilinearly arranged about a lengthwise axis of the flexible elongate member.

### Claim 53 (depends on 50)

The system of claim 50 wherein the array of transducer elements are circumferentially arranged about a lengthwise axis of the flexible elongate member.

### Claim 54 (depends on 48)

The system of claim 48 wherein the ultrasound device comprises a Doppler transducer.

### Claim 55 (depends on 54)

The system of claim 54 wherein the flexible elongate member comprises a guidewire.

### Claim 56 (depends on 46)

The system of claim 46 wherein the flexible elongate member is a guidewire and the diagnostic probe comprises a pressure sensor.

### Claim 57 (depends on 46)

The system of claim 46 wherein the radiopaque marker comprises a cylindrical marker band.

### Claim 58 (depends on 46)

The system of claim 46 wherein the radiopaque marker comprises at least one partially complete cylindrical marker band.

### Claim 59 (depends on 58)

The system of claim 58 wherein the radiopaque marker comprises two semi-cylindrical marker bands.

### Claim 60 (depends on 59)

The system of claim 59 wherein the two semi-cylindrical marker bands are skewed in relation to one another along a lengthwise axis of the flexible elongate member.

### Claim 61 (depends on 60)

The system of claim 60 wherein the display processor further comprises an orientation determination function for determining a relative orientation of the diagnostic probe within the vessel based upon at least a relative size and position of the two semi-cylindrical marker bands in relation to one another.

### Claim 62 (depends on 46)

The system of claim 46 wherein the third data is derived from user-specified points.

### Claim 63 (depends on 46)

The system of claim 46 wherein the third data is derived by automated processes that determine a position of the radiopaque marker within a field of view.

### Claim 64 (depends on 63)

The system of claim 63 wherein the automated processes utilize image pattern recognition to determine the position.

### Claim 65 (depends on 46)

The system of claim 46 wherein the third data is derived from a combination of manual user input and automated calculations.

### Claim 66 (depends on 65)

The system of claim 65 wherein the automated calculations include determination of a predicted path of the diagnostic probe.

### Claim 67 (depends on 46)

The system of claim 46 wherein the display processor further comprises a bookmark function enabling a user to designate particular images of interest in a stored set of images containing at least the intravascular image element.

### Claim 68 (depends on 46)

The system of claim 46 wherein the enhanced radiological image includes a calculated path of the diagnostic probe.

### Claim 69 (depends on 46)

The system of claim 46 wherein the display processor further comprises-a slider function associated with the cursor that enables a user to reposition the cursor to a point of interest on the enhanced radiological image through a user interface control, and in response displays a particular instance of the intravascular image element associated with the point of interest.

### Claim 70 (depends on 46)

The system of claim 46, wherein the estimated location is based at least in part on a calculated path of the diagnostic probe and wherein the calculated path is updated based on the error function that is calculated based on a difference between the estimated location of the radiopaque marker and the actual location of the radiopaque marker.

### Claim 71 (depends on 46)

The system of claim 46, wherein the intravascular image element is a cross-sectional intravascular ultrasound (IVUS) image.

### Claim 72 (depends on 46)

The system of claim 46, wherein the intravascular image element is a graph representing the intravascular data.

### Claim 73 (depends on 72)

The system of claim 72, wherein the graph represents at least one of blood pressure, blood flow velocity, shear stress, and fractional flow reserve.

### Claim 74

A method for acquiring and displaying intravascular information in a system including a flexible elongate member having a proximal end and a distal end, a diagnostic probe located near the distal end of the flexible elongate member, and configured to obtain information related to a vessel, and a radiopaque marker located near the diagnostic probe, the method comprising the steps of:
storing angiogram image data in a first memory;
storing intravascular data derived from information obtained by the diagnostic probe in a second memory;
storing radiopaque marker image data, distinct from the angiogram image data, in a third memory, the radiopaque marker image data being derived from information obtained from a fluoroscopic imaging device;
combining, by a display processor, data retrieved from the first memory, the second memory and the third memory to render a composite image including:
an enhanced radiological image derived from the angiogram image data comprising a superimposition of at least a portion of the angiogram data and the radiopaque marker data and providing a location of the radiopaque marker based upon an actual location during active fluoroscopy and an estimated location during inactive fluoroscopy, and
an intravascular image element corresponding to the intravascular data, wherein the enhanced radiological image and the intravascular image element are displayed proximate each other; and
displaying a cursor upon the enhanced radiological image, indicative of a location of the diagnostic probe while acquiring data for the intravascular image element presently displayed on the composite image, said cursor having a position that is based at least in part on third data derived from the radiopaque marker image data previously stored in the third memory;
wherein the estimated location is based on a calculated path of the diagnostic probe, and wherein an error function is calculated based on a difference between the estimated location of the radiopaque marker and the actual location of the radiopaque marker when active fluoroscopy is resumed after inactive fluoroscopy and wherein the error function is utilized to correct the calculated path.

### Claim 75 (depends on 74)

The method of claim 74 wherein the flexible elongate member is a catheter.

### Claim 76 (depends on 74)

The method of claim 74 wherein the diagnostic probe comprises an ultrasound device.

### Claim 77 (depends on 76)

The method of claim 76 wherein the ultrasound device comprises a Doppler transducer.

### Claim 78 (depends on 74)

The method of claim 74 wherein the flexible elongate member is a guidewire and the diagnostic probe comprises a pressure sensor.

### Claim 79 (depends on 74)

The method of claim 74 wherein the radiopaque marker comprises two semi-cylindrical marker bands that are skewed in relation to one another along a lengthwise axis of the flexible elongate member and wherein the method comprises determining an orientation of the diagnostic probe based upon at least a relative size and position of the two semi-cylindrical marker bands in relation to one another.

### Claim 80 (depends on 74)

The method of claim 74 wherein the third data is derived from user-specified points.

### Claim 81 (depends on 74)

The method of claim 74 wherein the third data is derived by automated processes that determine a position of the radiopaque marker within a field of view.

### Claim 82 (depends on 74)

The method of claim 74 wherein the third data is derived from a combination of manual user input and automated calculations.

### Claim 83 (depends on 82)

The method of claim 82 wherein the automated calculations determine a predicted path of the diagnostic probe.

### Claim 84 (depends on 74)

The method of claim 74 further comprising storing a user-designated set of particular images of interest in a stored set of images containing at least the intravascular image element.

### Claim 85 (depends on 74)

The method of claim 74 further comprising incorporating a calculated path of the diagnostic probe within the enhanced radiological image.

### Claim 86 (depends on 74)

The method of claim 74 further comprising providing a slider function associated with the cursor that enables a user to reposition the cursor to a point of interest on the enhanced radiological image through a user interface control, and in response display a particular instance of the intravascular image element associated with the point of interest.

### Claim 87 (depends on 74)

The method of claim 74, wherein the calculated path is calculated using a first multiplication coefficient if the diagnostic probe is being pulled through the vessel and a second multiplication coefficient if the diagnostic probe is being pushed through the vessel.

### Claim 88 (depends on 74)

The method of claim 74, wherein the intravascular image element is a cross-sectional intravascular ultrasound (IVUS) image.

### Claim 89 (depends on 74)

The method of claim 74, wherein the intravascular image element is a graph representing the intravascular data.

### Claim 90 (depends on 89)

The method of claim 89, wherein the graph represents at least one of blood pressure, blood flow velocity, shear stress, and fractional flow reserve.

### Claim 91

A system for acquisition and co-registered display of intravascular information, comprising:
a flexible elongate member having a proximal end and a distal end;
a diagnostic probe located near the distal end of the flexible elongate member, and configured to obtain information related to a vessel;
a radiopaque marker located near the diagnostic probe;
a first memory portion for storing angiogram image data;
a second memory portion for storing intravascular data derived from information obtained by the diagnostic probe;
a third memory portion for storing radiopaque marker image data, the radiopaque marker image data being derived from information obtained from a fluoroscopic imaging device;
a display processor that combines data retrieved from the first memory portion, the second memory portion and the third memory portion to render a composite image including:
an enhanced radiological image derived from the angiogram image data comprising a superimposition of at least a portion of the angiogram data and the radiopaque marker image data and providing a location of the radiopaque marker based upon an actual location during active fluoroscopy and an estimated location during inactive fluoroscopy, wherein an error function is calculated based on a difference between the estimated location of the radiopaque marker and the actual location of the radiopaque marker when active fluoroscopy is resumed after inactive fluoroscopy and wherein the error function is utilized to correct the estimated location of the radiopaque marker for the preceding period of inactive fluoroscopy,
an intravascular image element corresponding to the intravascular data, wherein the enhanced radiological image and the intravascular image element are displayed proximate each other; and
a cursor, displayed upon the enhanced radiological image, indicative of a location of the diagnostic probe while acquiring data for the intravascular image element presently displayed on the composite image, said cursor having a position that is based at least in part on third data derived from the radiopaque marker image data stored in the third memory portion.

### Claim 92 (depends on 91)

The system of claim 91, wherein the estimated location of the radiopaque marker is calculated using a first multiplication coefficient if the diagnostic probe is being pulled through the vessel and a second multiplication coefficient if the diagnostic probe is being pushed through the vessel.

### Claim 93 (depends on 91)

The system of claim 91, wherein the diagnostic probe is a catheter.

### Claim 94 (depends on 91)

The system of claim 91, wherein the diagnostic probe is a guidewire.

### Claim 95 (depends on 91)

The system of claim 91, wherein the diagnostic probe includes an ultrasound transducer.

### Claim 96 (depends on 91)

The system of claim 91, wherein the diagnostic probe includes a pressure sensor.

### Claim 97 (depends on 91)

The system of claim 91, wherein the intravascular image element is a cross-sectional intravascular ultrasound (IVUS) image.

### Claim 98 (depends on 91)

The system of claim 91, wherein the intravascular image element is a graph representing the intravascular data.

### Claim 99 (depends on 98)

The system of claim 98, wherein the graph represents at least one of blood pressure, blood flow velocity, shear stress, and fractional flow reserve.
