EP4669247A1 - OPTIMIZATION OF A CORONARY ARTERY BYPASS IMPLANT - Google Patents

OPTIMIZATION OF A CORONARY ARTERY BYPASS IMPLANT

Info

Publication number
EP4669247A1
EP4669247A1 EP23844030.9A EP23844030A EP4669247A1 EP 4669247 A1 EP4669247 A1 EP 4669247A1 EP 23844030 A EP23844030 A EP 23844030A EP 4669247 A1 EP4669247 A1 EP 4669247A1
Authority
EP
European Patent Office
Prior art keywords
recommended
graft
operating plan
processing circuitry
vessel
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP23844030.9A
Other languages
German (de)
French (fr)
Inventor
Max H. BILLARD
Thomas F. VALENZUELA
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medtronic Vascular Inc
Original Assignee
Medtronic Vascular Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Medtronic Vascular Inc filed Critical Medtronic Vascular Inc
Publication of EP4669247A1 publication Critical patent/EP4669247A1/en
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10Computer-aided planning, simulation or modelling of surgical operations
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/30Surgical robots
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B2017/00017Electrical control of surgical instruments
    • A61B2017/00203Electrical control of surgical instruments with speech control or speech recognition
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B2017/00017Electrical control of surgical instruments
    • A61B2017/00207Electrical control of surgical instruments with hand gesture control or hand gesture recognition
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/00234Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00238Type of minimally invasive operation
    • A61B2017/00243Type of minimally invasive operation cardiac
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10Computer-aided planning, simulation or modelling of surgical operations
    • A61B2034/101Computer-aided simulation of surgical operations
    • A61B2034/102Modelling of surgical devices, implants or prosthesis
    • A61B2034/104Modelling the effect of the tool, e.g. the effect of an implanted prosthesis or for predicting the effect of ablation or burring
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10Computer-aided planning, simulation or modelling of surgical operations
    • A61B2034/101Computer-aided simulation of surgical operations
    • A61B2034/105Modelling of the patient, e.g. for ligaments or bones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10Computer-aided planning, simulation or modelling of surgical operations
    • A61B2034/108Computer aided selection or customisation of medical implants or cutting guides

Definitions

  • This disclosure relates to the coronary artery bypass graft (CABG) procedure planning.
  • CABG coronary artery bypass graft
  • a CABG procedure is a medical procedure in which one or more vessels or portions thereof may be harvested from a patient and grafted to anatomy of a patient to bypass an occluded artery of the patient and improve blood flow to the anatomy.
  • the need for a CABG procedure may be determined by a clinician based on imaging data of a patient from an imaging system, such as a coronary computed tomography angiography (CCTA) imaging system or other imaging system, and/or other testing which may be undertaken by the clinician after presentation of coronary symptoms.
  • CABG procedures are typically performed based on general rules for general patient populations.
  • this disclosure is directed to various techniques and medical systems for generating an operating plan for a CABG procedure based on patient-specific data.
  • a medical system may use image data (e.g., CCTA image data and/or other image data, such as angiography or fractional flow reserve (FFR) angiography data) of vasculature of a particular patient and/or other patient-specific information, to determine recommendation(s) for graft locations, routing of a graft vessel, harvest location, harvest vessel length(s), and/or the like.
  • the medical system may present such recommendation(s) to a clinician in an operating plan.
  • the clinician may use such recommendations to assist the clinician during a CABG procedure.
  • the operating plan may include recommended graft locations(s), length(s) and diameter(s) of recommended graft(s), graft (e.g., harvest) vessel edge conditions (such as angle of cut, taper, etc.), recommended harvest vessel segments, recommended surgical access options to access anatomy of the patient, and/or the like. Because the anatomy of each patient may be different, a patient-specific operating plan may provide for better matching of donor vessel diameter to original blocked anatomy, better matching of harvested vessel segment length to length needed for the CABG procedure, and the like, than through the use of general rules based on the general population.
  • the techniques of this disclosure may improve patient outcomes by improving graft patency, reducing or minimizing harvest waste, reducing blood supply loss at harvest site(s), reducing or minimizing procedural time, and reducing or otherwise improving patient recovery time.
  • the medical system may provide the clinician with an opportunity to edit the recommendations to the clinician’s liking. For example, if the clinician would like to route a graft vessel in a different manner than recommended by the medical system, the clinician may use a user interface to edit the recommendation.
  • the techniques of this disclosure may provide for the more precise manner of determining location of grafts, which vessel segments to harvest, how much vessel to harvest, or the like for CABG procedures for a given patient via generation of a patientspecific operating plan, than conventional general population-based approach.
  • the present disclosure describes a technological improvement or a technical solution that is integrated into a practical application.
  • the techniques and systems of this disclosure may obtain input data, including imaging data of vasculature of a patient, determine an operating plan including a recommended location for a graft, and output the operating plan to a display.
  • the techniques and systems of this disclosure may facilitate improved CABG procedures, improved identification of harvest vessel segments of appropriate length, diameter, and/or other characteristics for use as a graft, etc., thereby improving patient outcomes.
  • a medical system includes: memory configured to store an operating plan for a coronary artery bypass graft (CABG) procedure; and processing circuitry communicatively coupled to the memory, the processing circuitry being configured to: obtain input data, the input data comprising imaging data of vasculature of a patient; determine, based on the input data, the operating plan, the operating plan comprising at least one recommended graft location, the recommended graft location including a recommended graft origin, a recommended graft path, and a recommended graft termination; and output, for display, the operating plan.
  • CABG coronary artery bypass graft
  • a method includes: obtaining, by processing circuitry, input data, the input data comprising imaging data of vasculature of a patient; determining, by the processing circuitry and based on the input data, an operating plan, the operating plan comprising at least one recommended graft location, the recommended graft location including a recommended graft origin, a recommended graft path, and a recommended graft termination; and outputting, by the processing circuitry and for display, the operating plan.
  • a non-transitory computer readable medium stores instructions, which, when executed, cause processing circuitry to: obtain input data, input data comprising imaging data of vasculature of a patient; determine, based on the input data, the operating plan, the operating plan comprising at least one recommended graft location, the recommended graft location including a recommended graft origin, a recommended graft path, and a recommended graft termination; and output, for display, the operating plan.
  • FIG. l is a schematic perspective view of an example medical system according to one or more aspects of this disclosure.
  • FIG. 2 is a block diagram of an example of a computing device in accordance with one or more aspects of this disclosure.
  • FIG. 3 is a block diagram illustrating contents of an example operating plan in accordance with one or more aspects of this disclosure.
  • FIG. 4. is a flow diagram illustrating example CABG operating plan techniques according to one or more aspects of this disclosure.
  • FIG. 5 is a conceptual diagram illustrating example potential harvest vessels according to one or more aspects of this disclosure.
  • FIG. 6A-D is a conceptual diagram illustrating different example surgical access techniques.
  • FIG. 7 is a conceptual diagram of an example three-dimensional (3D) model of a heart according to one or more aspects of this disclosure.
  • FIG. 8 is a conceptual diagram illustrating an example recommended graft location in accordance with one or more aspects of this disclosure.
  • FIG. 9 is a conceptual diagram illustrating an example harvested radial artery.
  • FIG. 10 is a conceptual diagram illustrating an example use of a 3D model generated based on imaging data other than CCTA imaging data in accordance with one or more aspects of this disclosure.
  • FIG. 11 is a conceptual diagram illustrating contents of another example operating plan in accordance with one or more aspects of this disclosure.
  • CABG procedures are performed in relatively high volumes globally, with approximately 340,000 in the United States of America per year alone. However, such CABG procedures do not appear to include much patient-specific planning in advance of the CABG procedures themselves.
  • CABG procedures are usually performed within a short window after acute symptoms are detected (e.g., within 48 hours) and clinicians, such as surgeons, tend to follow general guidelines for such CABG procedures applicable to the general population. In some cases, following guidelines applicable to the general population may make sense because patient-specific analysis may take time to perform, and performing the CABG procedure sooner rather than later may be better for the patient.
  • patient-specific CABG planning may be desirable, as patient-specific CABG planning may lead to better patient outcomes.
  • patient-specific CABG planning solutions that match vessels that may be harvested to the native anatomy could help with graft patency, reducing or minimizing harvest waste, and reducing or minimizing planning and procedural time. Such improvements may increase the quality of patient outcomes.
  • the techniques of this disclosure may include processing circuitry and/or software that interacts with patient scans (e.g., imaging data) and/or clinician input to generate an operating plan for CABG procedures.
  • the operating plan may include recommended graft locations(s), length(s) and diameter(s) of recommended graft(s), recommended harvest vessel segments, recommended entry options to access anatomy of the patient, and/or the like.
  • the operating plan may include a harvest site plan including a length of segment(s) of vessel(s) required for the CABG procedure, a suggested (e.g., optimal) segment of the vessel for each bypass, corresponding bypass pathways, and/or an indication of a need for saphenous vein graft (SVG) support if applicable.
  • SVG saphenous vein graft
  • the operating plan may include estimate(s) of flow restoration (e.g., distal segments restored and/or bypass comparison to an obstructed vessel).
  • the operating plan may include robotic positioning and access location(s) if applicable. Targeting outputs for the robot for anastomosis may also be generated and included.
  • such an operating plan may provide a clinician with advanced knowledge of potential case difficulties (e.g., graft length required, robotic articulation limitations, vessel condition, etc.) which may not be available if the clinician is utilizing a generalized population-based approach for the CABG procedure.
  • potential case difficulties e.g., graft length required, robotic articulation limitations, vessel condition, etc.
  • the use of such an operating plan by a clinician may result in improved blood flow in the patient due to minimized graft length and improved diameter matching between the occluded vessel and the grafted (e.g., harvested) vessel, and/or reduced blood supply loss to the harvest site.
  • the software may be updated to improve the efficacy of operating plans the software may generate.
  • the use of such an operating plan may save time in the operating room by reducing the time a clinician may take to select, cut and/or position a vessel for grafting.
  • the software may include a computer vision algorithm which may be trained to recognize vessels and characteristics thereof, such as diameter (e.g., inner diameter), length, identity of the vessel, whether the vessel is occluded, bifurcations of a vessel or lack thereof, and/or the like.
  • the computer vision algorithm may also be trained to recognize contours of anatomy, such as the heart, structures of the heart, potential obstacles to be avoided when determining a recommended graft path, or the like.
  • a clinician may consider a combination of a number of factors when planning a CABG procedure.
  • a clinician may consider which sites are available for harvest of a vessel.
  • graft vessels are harvested from any of, or any combination of, three locations: a radial artery, an internal mammary artery (IMA), or a saphenous spur (SVG).
  • Some of the possible harvest sites may be compromised from previous surgery, patient condition, or natural differences across patient anatomy. Bifurcations and/or branches at certain intervals of a potential harvest vessel may make the use of some vessel sections or segments difficult to use for grafting. With conventional CABG techniques, a clinician may not be aware of such bifurcations and/or branches prior to beginning the CABG procedure (e.g., prior to harvesting).
  • a clinician may consider the size of the occluded artery. It may be important to understand the length and diameter of the artery being replaced when performing a CABG procedure to ensure adequate blood flow is restored to the patient by the CABG procedure. For example, using a substantially narrower vessel segment (e.g., a vessel segment with a substantially lower inner diameter) than the occluded vessel as a graft, may not provide adequate blood flow. A clinician may consider which type of graft may most closely match the native blood flow in the patient. Currently, such a consideration is primarily determined by “rule-of-thumb.” For example, the American College of Cardiology describes the following.
  • LIMA left internal mammary artery
  • RIMA right internal mammary artery
  • IMA internal mammary artery
  • LCX left circumflex coronary artery
  • RCA right coronary artery
  • a left-sided artery may be bypassed with a radial artery if there is greater than 70% stenosis
  • a right-sided artery may be bypassed with a radial artery if there is greater than 90% stenosis.
  • the general patency from best to worst over time is set forth as IMA, then radial artery, then SVG.
  • a clinician may consider a number of bypasses that may be required. It is not unusual for multiple critical obstructions to be discovered simultaneously. As such, a clinician may desire to understand how a plurality of grafts may affect each other. [0033] A clinician may consider, if choosing SVG, any concerns with remodeling of the grafted vessel. Currently, SVG is the most common graft in the world due to the relative ease of harvest and working length of the vessel. Some of the SVG patency concerns appear to be linked to remodeling over time. The cause of the remodeling relates to the difference in arterial pressures and veinous pressures. In some examples, remodeling may be mitigated by a particular surgical technique or by adding device support to the SVG.
  • the clinician may also consider a graft location.
  • the distal graft connection should generally be made distal to a coronary blockage and should generally remain close to where the blockage ends to maximize the amount of revascularization.
  • the clinician may consider the proximal attachment location on the aorta of the grafted vessel. For example, based on how blood is supplied to the coronary arteries (e.g., diastole flow from the aorta), a clinician may consider making the proximal attachment as inferior on the Aortic root as possible. This is also supported by the natural right coronary artery (RCA) and left coronary artery (LCA) ostia.
  • RCA right coronary artery
  • LCA left coronary artery
  • the clinician may desire that the grafted vessel follow the contour of the heart with limited tension, slack and wasted length.
  • excess graft length may increase the chance of poor flow, e.g., due to kinking risk, dead zones, frictional losses, or the like.
  • FIG. l is a schematic perspective view of an example medical system according to one or more aspects of this disclosure.
  • Medical system 100 may include imager 140 (which may be a CCTA imager), display device 110, table 120, additional imager(s) 142, computing device 150, network 156, and server 160. In some examples, fewer or more components of medical system 100 may exist.
  • Medical system 100 may be used to for a medical procedure, such as a CABG procedure. Medical system 100 may generate and display an operating plan for the CABG procedure according to the techniques of this disclosure. For example, computing device 150 and/or server 160 may generate an operating plan including at least one recommended graft location. The recommended graft location may include a recommended graft origin, a recommended graft path, and a recommended graft termination. Medical system 100 may display the operating plan for viewing by a clinician, for example, on display device 110.
  • Such a medical system may facilitate a clinician to make better informed decisions prior to or during the CABG procedure which may improve graft patency, reduce or minimize harvest waste, reduce blood supply loss at harvest site(s), reduce or minimize procedural time, and reduce or otherwise improve patient outcomes, including recovery time.
  • Medical system 100 may be an example of a medical system for use in a surgical ward, a catheterization laboratory (Cath lab), or other healthcare environment.
  • medical system 100 may include other devices.
  • medical system 100 may be used during a medical procedure, such as a CABG procedure.
  • system 100 may be used during a diagnostic session to diagnose cardiovascular issues for a patient.
  • Computing device 150 may include, for example, an off-the-shelf device, such as a laptop computer, desktop computer, tablet computer, smart phone, or other similar device. In other examples, computing device 150 may be a special purpose computing device, such as one specifically designed to be used in medical system 100. Computing device 150 includes memory and processing circuitry. [0042] In some examples, computing device 150 may be configured to control a robotic medical device, an electrosurgical generator, a peristaltic pump, a power supply, or any other accessories and peripheral devices relating to, or forming part of, medical system 100. In some examples, computing device 150 may perform various control functions with respect to imager 140, additional imager(s) 142, display device 110, additional equipment 152, and/or the like. Computing device 150 may be communicatively coupled to imager 140, additional imager(s) 142, one or more devices of additional equipment 152, display device 110, server 160, and/or network 156.
  • features attributed to computing device 150 may be performed by processing circuitry of any of computing device 150, imager 140, server 160, network 156 (e.g., one or more computing devices forming or connected to network 156), other elements of medical system 100, or any combinations thereof.
  • processing circuitry associated with computing device 150 may be distributed and shared across any combination of computing device 150, imager 140, server 160, network 156, display device 110, additional equipment 152, and/or other elements of medical system 100.
  • processing operations or other operations performed by processing circuitry of computing device 150 may be performed by processing circuitry residing remotely, such as one or more cloud servers or processors. For purposes of ease of discussion herein, such processing circuitry may be considered a part of computing device 150.
  • Medical system 100 may include network 156, which is a suitable network such as a local area network (LAN) that includes a wired network or a wireless network, a wide area network (WAN), a wireless mobile network, a Bluetooth network, or the Internet.
  • network 156 may be a secure network, such as a hospital network, which may limit access by users.
  • network 156 may interconnect various devices of medical system 100.
  • Imager 140 may be a CCTA imager, and may image portions of a patient’s body, such as the area around or about the heart of the patient and areas having potential harvest vessels, during or before a medical procedure to visualize characteristics and locations of one or more occluded vessels to be bypassed, locations of potential grafts, anatomy of the patient in the area of the heart, characteristics and locations of potential harvest vessels, and/or the like. Additional imager(s) 142 may also be configured to image portions of a patient’s body, such as a cardiac vasculature of the patient.
  • additional imager(s) 142 may include one or more devices other than a CCTA imager, such as an angiography device (e.g., a fractional flow reserve (FFR) angiography device, ultrasound device (e.g., with an external probe, an intravenous probe, etc.), a fluoroscopy device, an optical coherence tomograph (OCT) device, a near infrared spectroscopy (NIRS) device, a magnetic resonance imaging (MRI) device, a positron emission tomography (PET) device, or the like.
  • Additional imager(s) 142 may capture detail of the anatomy of the patient that may not be captured by imager 140 which may be used to update and/or provide further details for the operating plan.
  • additional imager(s) 142 may capture imaging data of the patient prior to the CABG procedure, e.g., during the same visit to the facility as for the CABG procedure, during a different visit to the facility, or a visit to another facility. In some examples, additional imager(s) 142 may capture imaging data of the patient during the CABG procedure.
  • computing device 150 may be configured to obtain clinician input, such as through a user interface, which computing device 150 may use to iterate the operating plan. For example, the clinician may input a graft angle preference, change a location of a recommended graft, change a desired harvest vessel, or the like. Computing device 150 may then update the operating plan based on the clinician input.
  • Computing device 150 may be configured to execute a computer vision algorithm to determine the operating plan or portions thereof, such as to determine recommended graft locations, determine recommended harvest segments, and/or to generate a three-dimensional (3D) model of the heart and surrounding vascular tissue.
  • computing device 150 may obtain input data, the input data comprising imaging data of vasculature of a patient.
  • computing device 150 may obtain imaging data from imager 140 and/or additional imager(s) 142.
  • Computing device 150 may determine, based on the input data, an operating plan, the operating plan comprising at least one recommended graft location, the recommended graft location including a recommended graft origin, a recommended graft path, and a recommended graft termination.
  • Computing device 150 may output, for display, the operating plan.
  • computing device may output the operating plan to display device 110 for display such that a clinician may view the operating plan.
  • Additional equipment 152 may include devices configured to be used during a medical procedure, such as a CABG procedure, including, but not limited to, clamps, forceps, scissors, a cardiopulmonary bypass machine, tubing, SVG support devices, or the like.
  • Display device 110 may be configured to display captured imaging data, from, for example, imager 140 and/or additional imager(s) 142.
  • display device 110 may be configured to display a 3D model of the coronary vasculature of a patient (which may be part of an operating plan), instead of or in addition to captured imaging data.
  • display device 110 may be configured to display the various user interfaces disclosed herein. In some examples display device 110 may be configured to display an operating plan and/or revised operating plan as disclosed herein. Display device 110 may be configured to display any other content discussed as being displayed in this disclosure.
  • Table 120 may be, for example, an operating table or other table suitable for use during a medical procedure, such as a CABG procedure. Although depicted as being in the same environment as imager 140, in some examples, table 120 may not be a same environment as imager 140.
  • Server 160 may be configured to store data obtained by and/or determined or generated by computing device 150. In some examples, server 160 may be configured to perform techniques attributed to computing device 150. Server 160 may be communicatively coupled to computing device 150, for example, by wired, optical, or wireless communications and/or by network 156. Server 160 may be a hospital server which may or may not be located in an operating room, such as a cloud-based server, or the like. Server 160 may be configured to store patient data, electronic patient records, or the like.
  • FIG. 2 is a block diagram of an example of a computing device in accordance with one or more aspects of this disclosure.
  • Computing device 200 may be an example of computing device 150, a computing device of network 156, and/or server 160 of FIG. 1 and may include a workstation, a desktop computer, a laptop computer, a server, a smart phone, a tablet, a dedicated computing device, or any other computing device capable of performing the techniques of this disclosure.
  • computing device 200 may be configured to perform processing, control and other functions associated with various devices of FIG. 1, such as display device 110, imager 140, additional imager(s) 142, and/or additional equipment 152.
  • Computing device 200 may include, for example, a memory 202, processing circuitry 204, a display 206, a network interface 208, an input device(s) 210, or an output device(s) 212, each of which may represent any of multiple instances of such a device within the computing system, for ease of description.
  • processing circuitry 204 appears in computing device 200 in FIG.
  • processing circuitry 204 may be performed by processing circuitry of any of computing device 150, imager 140, server 160, computing devices of network 156, or other components of FIG. 1.
  • one or more processors associated with processing circuitry 204 in computing device 200 may be distributed and shared across any combination of computing device 150, imager 140, server 160, computing devices of network 156, or other components of FIG. 1.
  • processing operations or other operations performed by processing circuitry 204 may be performed by one or more processors residing remotely, such as one or more cloud servers or processors, each of which may be considered a part of computing device 200.
  • Computing device 200 may be used to perform any of the techniques described in this disclosure, and may form all or part of devices or systems configured to perform such techniques, alone or in conjunction with other components, such as components of computing device 150, imager 140, server 160, computing devices of network 156, other components of FIG. 1, or a system including any or all of such devices.
  • Memory 202 of computing device 200 includes any non-transitory computer- readable storage media for storing data or software that is executable by processing circuitry 204 and that controls the operation of computing device 150.
  • memory 202 may include one or more solid-state storage devices such as flash memory chips.
  • memory 202 may include one or more mass storage devices connected to the processing circuitry 204 through a mass storage controller (not shown) and a communications bus (not shown).
  • computer-readable media refers to a solid- state storage
  • computer-readable storage media may be any available media that may be accessed by the processing circuitry 204. That is, computer readable storage media includes non-transitory, volatile and non-volatile, removable and non-removable media implemented in any method or technology for storage of information such as computer-readable instructions, data structures, program modules, or other data.
  • computer-readable storage media includes RAM, ROM, EPROM, EEPROM, flash memory or other solid state memory technology, CD-ROM, DVD, Blu-Ray or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium that may be used to store the desired information and that may be accessed by computing device 200.
  • computer-readable storage media may be stored in the cloud or remote storage and accessed using any suitable technique or techniques through at least one of a wired or wireless connection.
  • Memory 202 may store computer vision algorithm 224.
  • Computer vision algorithm 224 may be trained using imaging data collected from past medical procedures and/or user input data.
  • Memory 202 may also store user interface(s) 218.
  • User interface(s) 218 may include one or more user interfaces which processing circuitry 204 may output for display by display 206 and/or display device 110. For example, a clinician may interact with user interface(s) 218 to provide input data for use by processing circuitry 204 to generate, update, or modify an operating plan.
  • Memory 202 may store imaging data 214, operating plan(s) 220, electronic patient record 236, 3D model(s) 232. Imaging data 214 may be captured by imager 140 and/or additional imager(s) 142 (FIG. 1) during a medical procedure of a patient.
  • Processing circuitry 204 may obtain imaging data 214 from imager 140 and/or additional imager(s) 142 and store imaging data 214 in memory 202. Processing circuitry 204 may use imaging data 214 to determine operating plan(s) 220, and/or the like. Processing circuitry 204 may use imaging data 214 to determine one or more 3D model(s) and/or update one or more 3D model(s) 232. Processing circuitry 204 may use information obtained from a clinician to iterate and update operating plan(s) 220.
  • Processing circuitry 204 may execute any of user interface(s) 218 so as to cause display 206 (and/or display device 110 of FIG. 1) to present that UI of user interface(s) 218 to one or more clinicians performing the medical procedure.
  • processing circuitry 204 may obtain information indicative of one or more occluded arteries.
  • processing circuitry 204 may obtain, from imager 140, which may be a CCTA imager, data relating to current arterial blockages.
  • processing circuitry 204 may, additionally, or alternatively, obtain data relating to potential graft sites.
  • processing circuitry 204 may obtain, from imager 140, image data of potential graft sites, and/or obtain, from a user interface (e.g., input device(s) 210) or network interface 208, manually entered information relating to potential graft sites.
  • Processing circuitry 204 may obtain a Coronary Perfusion Pressure (CPP) or an estimate of the CPP, for example from a device of additional equipment 152.
  • CPP may be a measure of a difference between aortic diastolic pressure and left ventricular end- diastolic pressure.
  • Processing circuitry 204 may obtain clinician graft preferences, for example, from a user interface (e.g., input device(s) 210) or a network interface 208.
  • Processing circuitry 204 may obtain an indication of whether the procedure is a robotic or robotic-assisted procedure, for example, from a user interface (e.g., input device(s) 210) or network interface 208.
  • Processing circuitry 204 may, from the obtained information/data, determine one or more suggested (e.g., optimal) locations for proximal anastomosis to the aorta, shortest graft path(s) to bypass the blockage or blockages, suggested suitable graft length(s) to accomplish total (or adequate) restoration of blood flow, suitable donor vessels as graft options based on blocked artery diameter and length required to restore flow, estimates for required SVG support (if it is possible to calculate based on available data) as sometimes SVG vein grafts may collapse, options to reach an IMA graft from the chest wall, an initial estimate for a robotic or robotic assisted surgical approach to minimize incision size, and/or the like.
  • suggested e.g., optimal
  • processing circuitry 204 may generate an operating plan(s) 220 including any of or any combination of such information.
  • Processing circuitry 204 may store operating plan(s) 220 in memory 202.
  • Processing circuitry 204 may control a display device (e.g., display 206, display device 110, etc.) to display operating plan(s) 220 for a clinician to view.
  • a display device e.g., display 206, display device 110, etc.
  • processing circuitry 204 may facilitate a clinician interacting with operating plan(s) 220.
  • processing circuitry 204 may allow a clinician, via a user interface(s) 218, input device(s) 210, and/or network interface 208, to confirm or modify Aorta and/or vessel anastomosis locations.
  • processing circuitry 204 may permit a clinician to review operating plan(s) 220 and any associated imaging data 214 to view potential bypass sites to ensure the potential bypass sites are free from plaque buildup or other potential obstructions.
  • Processing circuitry 204 may permit the clinician to select a graft site location, which processing circuitry 204 may record in operating plan(s) 220.
  • Processing circuitry 204 may permit a clinician to modify a robotic approach if so desired and store the modified approach in operating plan(s) 220.
  • processing circuitry 204 may iterate on operating plan(s) 220 and generate a finalized operating plan. For example, processing circuitry 204 may base a finalized operating plan on the original operating plan and any clinician input. Processing circuitry 204 may store the finalized operating plan in operating plan(s) 220.
  • the finalized operating plan of operating plan(s) 220 may include a harvest site plan including a length of segment(s) required for the CABG procedure, a suggested (e.g., optimal) segment of the harvest vessel for each bypass, corresponding bypass pathways, an indication of the need for SVG support, if applicable, and/or the like.
  • the finalized operating plan of operating plan(s) 220 may include estimates of flow restoration (e.g., distal segments restored and bypass comparison to obstructed vessel).
  • the finalized operating plan of operating plan(s) 220 may include robotic positioning and access location(s) if applicable and/or targeting outputs for the robot for anastomosis.
  • processing circuity 204 may control display 206, output device(s) 212, and/or display device 110, to display the operating plan (e.g., the finalized operating plan), for example, to provide real time guidance during a harvest portion and/or bypass portion of the CABG procedure.
  • Display of the operating plan may assist a clinician in better understanding a harvest location, selecting an appropriate graft length, and determining the specific sections of the harvest vessels that are uninterrupted by branches. As such, the harvest operation of the CABG procedure may be expedited and blood supply loss to the harvest site may be reduced.
  • Display of the operating plan may assist a clinician in understanding the required length of an IMA graft and whether the IMA graft can reach past the blockage without tension.
  • display of the operating plan may minimize (or reduce) the required length of vessel dissected from a chest wall of the patient.
  • Display of the operating plan may also assist the clinician in attaching the bypass grafts to the ideal (e.g., suggested) locations on the Aorta to prevent crowding and/or crossing of vessels while maximizing blood flow to impacted areas of the heart of the patient.
  • Processing circuitry 204 may assist the clinician in selecting the location(s) for aorta anastomosis. For example, processing circuitry 204 may identify the ascending aorta and pulmonary artery from imaging data 214, via execution of computer vision algorithm 224, which may be trained to identify such vessels. For example, it may be desirable for the graft to be attached as close to the aortic valve as possible so as to mimic native anatomy. However, it also may be desirable that the graft navigate around the pulmonary artery trunk without turning downward and risking poor blood flow.
  • processing circuitry 204 may organize bypasses based on proximity to occlusions and assume an anterior sternotomy approach.
  • the origination point may be adjusted by the clinician following an initial operating plan recommendation.
  • a clinician may desire to adjust the origin point in the initial operating plan if there is a patient condition which invalidates the initial placement, such as calcification which can affect anastomosis success.
  • the clinician may, via input device(s) 210, user interface(s) 218, and/or network interface 208, adjust the origin point in the initial operating plan.
  • processing circuitry 204 may determine a recommended (e.g., optimal) aorta graft location and determine potential obstacles, based on imaging data 214.
  • processing circuitry 204 may execute computer vision algorithm 224 to determine potential obstacles and processing circuitry 204 may determine the recommended aorta graft location to include a recommended graft path that avoids such obstacles.
  • processing circuitry 204 may, through 3D model(s) 232 and/or operating plan(s) 220, facilitate the clinician placing a representative clamp and aortic root cannula in a model of the anatomy of the patient. Clamps and aortic root cannulas may reduce the amount of usable aorta for the CABG procedure. By allowing the clinician to represent such devices in 3D model(s) 232, processing circuitry 204 may determine better anastomosis location recommendations and better flow restoration estimates. For example, computer vision algorithm 224 may be trained on data including imaging data with claims and/or aortic root cannulas attached from past procedures and flow data associated with past procedures. As such, the clinician may, via input device(s) 210, user interface(s) 218, and/or network interface 208, place a representative clamp and/or aortic root cannula in 3D model(s) 232.
  • Processing circuitry 204 may determine recommended paths for each bypass based on imaging data 214. For example, it may be desirable for a path to generally run parallel to native anatomy and processing circuitry 204 may recommend a path for each bypass that runs parallel or generally parallel to native anatomy that appears in imaging data 214. For example, once the source and initial curvature is established, processing circuitry 204 may generate the remaining path elements. For example, processing circuitry 204 may generate a 3D model of the heart (e.g., of 3D model(s) 232) based on obtained imaging data, such as CCTA scans. In some examples, one or more of 3D model(s) 232 is part of one or more operating plan(s) 220.
  • processing circuitry 204 may determine a length of harvest vessel to be harvested.
  • processing circuitry 204 may include some additional length, such as 1-2 mm, for the clinician to work with.
  • Processing circuitry 204 may identify the restricted flows and extent of each blockage, based on the obtained imaging data 214 and/or manually input data. For example, if processing circuitry 204 recommends a merge with the occluded vessel 8mm past the blockage (which may be editable by the clinician), processing circuitry 204 may generate a contour generally following the native vessel when possible and the outer contour of the heart merging tangent to the first path section (e.g., to avoid a pulmonary trunk). Once processing circuitry 204 generates the full path, processing circuitry 204 may translate the path’s length into individual graft required lengths and an overall length of harvest which may be required to perform all of the grafts of the CABG procedure.
  • vessel diameter may play a role in graft success.
  • processing circuitry 204 may, based on imaging data 214, such as CCTA scan data of the obstructed vessel(s) and/or harvest site information, rank the possible graft vessels and/or segments based on how similar each diameter (e.g., inner diameter) of a possible harvest vessel and/or segment is to a diameter (e.g., inner diameter) of the obstructed anatomy.
  • the patient’s radial artery may be an appropriate vessel for a graft (e.g., a good match) with straightforward anastomosis.
  • Processing circuitry 204 recommend and/or may facilitate a clinician inputting, e.g., via input device(s) 210, user interface(s) 218, and/or network interface 208, other information for inclusion into the finalized operating plan of operating plan(s) 220.
  • a clinician may enter a contour of anastomosis cut (e.g., angled or straight) which would affect a length of graft and blood flow characteristics.
  • a clinician may enter a desire for excess slack for the graft to allow for a retry of an anastomosis if the initial anastomosis fails.
  • processing circuitry 204 may add additional length to suggested or proposed donor vessel(s) and/or segment(s) to be harvested.
  • a clinician may enter a desire to use a graft vessel from a single source for all bypasses of a given CABG procedure to preserve harvest sites, which may speed up the harvesting procedure and potentially reduce the number of harvest procedures performed.
  • processing circuitry 204 may recommend taking the vessel segments for the grafts from a particular location, e.g., SVG, if three grafts are to be performed and only the SVG can provide graft vessel segments for all three grafts.
  • processing circuitry 204 may determine a recommended graft location based at least in part on the diameter (e.g., inner diameter) of the harvested vessel.
  • a clinician may harvest segment(s) of a vessel and may desire to use such segment(s) as graft(s). Because the inner diameter of a segment to be used as a graft may not necessarily match the inner diameter of the occluded vessel at a given location, processing circuitry may determine where to locate the graft based, at least in part, on the inner diameter of the harvest segment. Such a location may be different than if the segment has an inner diameter that matches the inner diameter of the occluded vessel.
  • an IMA also called internal thoracic artery (ITA)
  • ITA internal thoracic artery
  • An IMA typically runs along the inside of the chest wall and supplies blood to the anterior chest. Often this vessel is dissected and repositioned to supply blood distal to a blockage.
  • Processing circuitry 204 may determine a recommendation, when using an IMA for a graft vessel, that may minimize or reduce dissection of the IMA from the chest wall to mitigate blood supply loss to an anterior chest wall (which may be associated with sternal wound infection).
  • processing circuitry 204 may recommend harvest such as excise the IMA from chest wall up to a specified rib, rather than all the way up to the collar bone.
  • Processing circuitry 204 may examine the potential harvest sites and provide recommendations and/or ranking of potential harvest vessel segments, based on bypass needs, as determined by processing circuitry 204 and/or entered by a clinician. For example, processing circuitry 204 may utilize bypass path determinations, such as (individual segment diameter, length, and/or total procedural needs) and inputs from preliminary harvest site scans (e.g., imaging data 214) to provide guidance during harvest.
  • a minimal total harvest length required for all the grafts to be performed during the CABG procedure may be utilized to determine a harvest location.
  • the SVG is normally substantially longer than the radial artery allowing for more and/or longer bypass requirements.
  • an inner diameter of a potential harvest vessel may be utilized to determine a harvest vessel. For example, it may be desirable for a graft inner diameter to match or relatively match an inner diameter of the occluded vessel.
  • processing circuitry 204 may provide the clinician with an option to utilize a typical anatomy representation for the patient.
  • the typical anatomy may be based on a typical person.
  • the typical anatomy may include length and/or diameter for harvest site vessel(s) which may equate to a length and/or diameter of harvest site vessel(s) for an average person.
  • imaging data 214 may be available, the clinician may use the operating plan of operating plan(s) 220 to plan out multiple vessel sections within a single harvest operation. For example, sections with limited branch interruption may be preferred and may match up with the required lengths for bypass.
  • processing circuitry 204 may facilitate the limitation of the removal of donor vessel tissue to only what is required for the grafts, thus reducing the blood supply loss at the harvest site.
  • Processing circuitry 204 may providing an estimation of restored blood flow that is predicted to occur after a CABG procedure following the operating plan and include such an estimation in the operating plan. Processing circuitry 204 may, based on the planned grafts, utilize a flow diagnosis model to estimate restored flow to regions after the CABG procedure. In some examples, processing circuitry 204 may display such planned grafts together with determined restored flow estimates as part of the operating plan. Such information may be useful to a clinician and may impact a clinician’s decision about whether or not to change the operating plan.
  • a display may display a representation (e.g., via a color) of an estimated FFR based on the planned grafts in the graft vessel and other affected vessels as set forth in the operating plan. For example, the bypassed vessel may be shown in red, indicating a poor FFR, while the planned graft vessel(s) may be displayed in white, green, or another color, indicating a good or acceptable FFR and restored blood flow.
  • a clinician may review the operating plan and determine that the operating plan provides for an appropriate outcome prior to proceeding with the CABG procedure. If the clinician reviews the operating plan and determines that the operating plan does not provide for an appropriate outcome, the clinician may modify the operating plan prior to proceeding with the CABG procedure. In such a case, processing circuitry 204 may update the operating plan and control a display to display an updated estimated FFR based on the modified operating plan.
  • processing circuitry 204 may consider competing blood flows in determining the restored flow estimates. For example, processing circuitry 204 may consider residual flow through the occluded vessel, flow through the proposed graft, and any reduced flow to the original ostia. If any of these may present concerns (e.g., negatively affect a blood flow analysis), processing circuitry 204 may provide a warning to the clinician and/or recommend adjustments to the operating plan. For example, a graft may shrink because of blood flow issues, which may not be beneficial to the patient. [0086] In some examples, processing circuitry 204 may determine estimates of backflow from the graft into the native vessel.
  • processing circuitry 204 may, based on such determined estimates of backflow, warn against poor hemodynamics and the potential for backflow to dislodge calcium deposits leading to new obstructions distally. For example, if the determined estimates of backflow meet a backflow threshold, processing circuitry 204 may provide a such a warning to the clinician via a display (such as display 206) or any of output device(s) 212. Such a warning may be visual, auditory, haptic, or the like.
  • the techniques of this disclosure may be utilized with a patient who is at intermediate or low risk of clinical events.
  • a patient may present with initial symptoms and undergo one or more screenings which may include CCTA or other imaging to collect imaging data 214.
  • a clinician may elect to use traditional “rule-of-thumb” techniques for patients that are most severe rather than use the patient-specific technique so this disclosure.
  • Processing circuitry 204 may determine recommended graft locations or combination of graft locations based on input data, such as imaging data 214. Additionally, or alternatively, processing circuitry 204 may determine recommended harvest segments based on input data, such as imaging data 214. Processing circuitry 204 may control a display (e.g., display 206) to display or otherwise provide recommendations (an initial operating plan of operating plan(s) 220) to a clinician. Processing circuitry 204 may provide a clinician with an opportunity to refine the initial operating plan. For example, the clinician may change a location for new ostium on the aorta for graft number 2.
  • Processing circuitry 204 may redetermine the recommendations and output for display a revised operating plan of operating plan(s) 220) based on the clinician input, which processing circuitry 204 may iterate with the clinician. Processing circuitry 204 may generate a finalized operating plan for use by the clinician in preparing for and/or during the CABG procedure.
  • Processing circuitry 204 may be implemented by one or more processors, which may include any number of fixed-function circuits, programmable circuits, or a combination thereof. In various examples, control of any function by processing circuitry 204 may be implemented directly or in conjunction with any suitable electronic circuitry appropriate for the specified function.
  • Fixed-function circuits refer to circuits that provide particular functionality and are preset on the operations that may be performed.
  • Programmable circuits refer to circuits that may programmed to perform various tasks and provide flexible functionality in the operations that may be performed. For instance, programmable circuits may execute software or firmware that cause the programmable circuits to operate in the manner defined by instructions of the software or firmware.
  • Fixed-function circuits may execute software instructions (e.g., to receive parameters or output parameters), but the types of operations that the fixed-function circuits perform are generally immutable.
  • the one or more of the units may be distinct circuit blocks (fixed-function or programmable), and in some examples, the one or more units may be integrated circuits.
  • processors such as one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), graphics processing units (GPUs) or other equivalent integrated or discrete logic circuitry.
  • DSPs digital signal processors
  • ASICs application specific integrated circuits
  • FPGAs field programmable gate arrays
  • GPUs graphics processing units
  • processing circuitry 204 as used herein may refer to one or more processors having any of the foregoing processor or processing structure or any other structure suitable for implementation of the techniques described herein.
  • the functionality described herein may be provided within dedicated hardware or software modules configured for encoding and decoding, or incorporated in a combined codec. Also, the techniques could be fully implemented in one or more circuits or logic elements.
  • Display 206 may be touch sensitive or voice activated, enabling display 206 to serve as both an input and output device.
  • a keyboard (not shown), mouse (not shown), joystick (not shown) or other data input device(s)s (e.g., input device(s) 210) may be employed.
  • display 206 may include a virtual reality and/or augmented reality headset.
  • display 206 may include a hologram device.
  • Network interface 208 may be adapted to connect to a network (e.g., network 156) such as a local area network (LAN) that includes a wired network or a wireless network, a wide area network (WAN), a wireless mobile network, a Bluetooth network, or the internet.
  • network interface 208 may include one or more application programming interfaces (APIs) for facilitating communication with other devices.
  • computing device 200 may receive imaging data 214 from imager 140 and/or additional imager(s) 142 during a medical procedure via network interface 208.
  • Computing device 200 may interact with server 160 via network interface 208.
  • Computing device 200 may receive updates to its software, for example, applications 216, via network interface 208.
  • Computing device 200 may also display notifications on display 206 that a software update is available.
  • Input device(s) 210 may include any device that enables a user to interact with computing device 200, such as, for example, a mousejoystick, keyboard, foot pedal, touch screen, augmented-reality input device(s) receiving inputs such as hand gestures or body movements, or voice interface.
  • Output device(s) 212 may include any connectivity port or bus, such as, for example, parallel ports, serial ports, universal serial busses (USB), or any other similar connectivity port known to those skilled in the art.
  • connectivity port or bus such as, for example, parallel ports, serial ports, universal serial busses (USB), or any other similar connectivity port known to those skilled in the art.
  • Applications 216 may include one or more software programs stored in memory 202 and executed by processing circuitry 204 of computing device 200.
  • FIG. 3 is a conceptual diagram illustrating an example operating plan according to one or more aspects of this disclosure.
  • Operating plan 300 may be an example of any of operating plan(s) 220, such as an original operating plan, an iteration of an operating plan, or a final operating plan.
  • Operating plan 300 may include recommended graft location(s) 302.
  • Recommended graft location(s) 302 may include, for each recommended graft, one or more of a recommended graft origin, a recommended graft path, and a recommended graft termination.
  • recommended graft location(s) 302 may include, for a given recommended graft location a recommended graft origin (which may be one of distal to or proximal to a blockage) and a recommended graft termination (which may be the other of distal to or proximal to a blockage) and a recommended graft path therebetween.
  • Operating plan 300 may include a recommended vessel edge condition 330.
  • recommended vessel edge condition 330 may include a recommended cut angle (angle of cutting of the vessel to be used for a graft), a recommended taper (or lack thereof), or other condition of an edge or end of a vessel to be used for a graft.
  • processing circuitry 204 may perform a flow analysis and determine that a particular cut angle of a vessel to be used for a graft may provide an acceptable or preferred rate of flow after the CABG procedure and recommend that cut angle (e.g., 45 degrees) in recommended vessel edge condition 330.
  • Operating plan 300 may include a harvest plan 304.
  • Harvest plan 304 may include recommended segment(s) to harvest from a harvest vessel to use for the grafts.
  • Processing circuitry 204 may determine such recommended segment(s) based on the length of segment (e.g., segment length 322) needed to traverse recommended graft path 310 and attach at recommended graft origin 306 and recommended graft termination 308, and/or the determined diameter (e.g., inner diameter) of the occluded vessel 332 and the determined diameter (e.g., inner diameter) of the harvest vessel segment (segment diameter 324).
  • harvest plan 304 may include a length of segment(s) required for the CABG procedure, a suggested (e.g., optimal) segment of the harvest vessel for each bypass, corresponding bypass pathways, an indication of the need for SVG support, if applicable, and/or the like.
  • operating plan 300 may include one or more of 3D model(s) 232 described above with respect to FIG. 2.
  • operating plan 300 may include imaging data 214.
  • operating plan 300 may include SVG support 312, such as an estimated need for (or lack of a need for) SVG support and/or a recommendation for one or more SVG support devices to be used during the CABG procedure.
  • operating plan 300 may include one or more recommendations for dissecting an IMA graft from a chest wall (reach IMA 314), such as a recommended rib at which to cease detaching the IMA from the chest wall.
  • operating plan 300 may include an estimate of flow restoration 316 to be accomplished by the CABG procedure.
  • estimate of flow restoration 316 may include an estimated fractional flow reserve (FFR) value associated with a graft to be accomplished during the CABG procedure.
  • operating plan 300 may include an indication of a recommendation of robotic assistance 318 for the CABG procedure, such as a recommendation for a robotic assisted surgical approach.
  • recommendation of robotic assistance 318 may include a recommended robotic positioning, at least one recommended access location on the patient, and/or at least one target output for robotic anastomosis.
  • operating plan 300 may include a recommendation for a surgical access strategy 320, such as how to access an area of the patient for attachment of a graft while minimizing incision size.
  • FIG. 4 is a conceptual diagram illustrating example operating plan techniques according to one or more aspects of this disclosure. While described as being performed by computing device 200 of FIG. 2, the techniques of FIG. 4 may be performed by any device or combination of devices of medical system 100 of FIG. 1 or any device(s) capable of performing these techniques.
  • Processing circuitry 204 obtain input data, the input data including imaging data of vasculature of a patient (400). For example, processing circuitry 204 may obtain input data, including imaging data 214 of vasculature of a patient from imager 140 and/or additional imager(s) 142. Processing circuitry 204 may determine, based on the input data, an operating plan, the operating plan including at least one recommended graft location, the recommended graft location including a recommended graft origin, a recommended graft path, and a recommended graft termination (402). For example, processing circuitry 204 may determine operating plan 300 that is patient-specific for the patient.
  • Operating plan 300 may include at least one recommended graft location (e.g., recommended graft location(s) 302).
  • the recommended graft location may include at least one of a recommended graft origin 306 (e.g., the location of the first attachment of a graft), a recommended graft path 310 (e.g., the route a grafted vessel may take from the graft origin to the graft termination), and a recommended graft termination 308 (e.g., the location of the second attachment of the graft).
  • Processing circuitry 204 may output, for display, the operating plan (404). For example, processing circuitry 204 may output operating plan 300 to display 206 and/or display device 110.
  • the at least one recommended graft location includes a recommended graft location for proximal anastomosis to an aorta. In some examples, the at least one recommended graft location includes a recommended graft location for distal anastomosis distal to a coronary obstruction. In some examples, the recommended graft path includes a path between the recommended graft origin and the recommended graft termination, the recommended graft path being configured to avoid any obstacles between the recommended graft origin and the recommended graft termination.
  • operating plan 300 further includes at least one recommended vessel edge condition of a vessel to be used for a graft.
  • the at least one recommended vessel edge condition comprises at least one cut angle.
  • processing circuitry 204 is further configured to determine one or more recommended harvest vessel segment lengths based, at least in part, on the at least one recommended graft location.
  • operating plan 300 further includes the one or more recommended harvest vessel segment lengths.
  • processing circuitry 204 is further configured to determine at least one recommended harvest vessel segment, the at least one recommended harvest vessel segment being based, at least in part, on the one or more recommended harvest vessel segment lengths, and a recommended harvest vessel anatomy.
  • operating plan 300 further includes a harvest plan, the harvest plan including an identification of the at least one recommended harvest vessel segment.
  • the recommended harvest vessel anatomy includes a recommended harvest vessel diameter, the recommended harvest vessel diameter being based on a diameter of an obstructed vessel.
  • processing circuitry 204 is further configured to obtain user input associated with operating plan 300.
  • the user input may be obtained during the CABG procedure.
  • the user input may be obtained prior to the CABG procedure.
  • processing circuitry 204 may amend operating plan 300 based on the user input to generate an amended operating plan or iteration of the operating plan (e.g., of operating plan(s) 220).
  • processing circuitry 204 is configured to output, for display, the amended operating plan.
  • imaging data 214 includes CCTA imaging data.
  • imaging data 214 includes angiogram imaging data.
  • imaging data 214 includes FFR angiogram imaging data.
  • imaging data 214 includes at least one of imaging data of at least one blocked vessel or imaging data of at least one potential harvest vessel.
  • the input data further includes at least one of information relating to at least one potential harvest vessel, a measure or an estimate of coronary perfusion pressure (CPP), or an indication of whether the CABG procedure is a robotic assisted procedure.
  • CPP coronary perfusion pressure
  • a clinician may input such information via user interface(s) 218, input device(s) 210 or network interface 208, and/or processing circuitry 204 may obtain such information from additional equipment 152.
  • processing circuitry 204 is further configured to determine at least one of an estimate for SVG support, one or more recommendations for dissecting an IMA graft from a chest wall, or one or more recommendations of a robotic assisted surgical approach.
  • operating plan 300 may further include at least one of the estimate for SVG support, the one or more recommendations for dissecting an IMA graft from a chest wall, or the one or more recommendations of a robotic assisted surgical approach.
  • processing circuitry 204 is further configured to determine an estimate of flow restoration based on at least one of the recommendations.
  • operating plan 300 may further include a representation of the estimate of flow restoration.
  • processing circuitry 204 is further configured to determine at least one of recommended robotic positioning, at least one recommended access location on the patient, or at least one target output for robotic anastomosis.
  • operating plan 300 may include at least one of the recommended robotic positioning, the at least one recommended access location on the patient, or the at least one target output for robotic anastomosis.
  • Operating plan 300 may provide a clinician with advanced knowledge of case specifics (e.g., graft length required, robotic articulation limitations, vessel condition, etc.).
  • a CABG procedure being performed by a clinician utilizing operating plan 300 may result in improved blood flow due minimizing graft length and matching vessel diameters and reduced blood supply loss to harvest site when compared to not using such an operating plan.
  • the use of operating plan 300 may result in CABG procedure time savings, for selecting, cutting and/or positioning grafts.
  • FIG. 5 is a conceptual diagram illustrating example potential harvest vessels according to one or more aspects of this disclosure.
  • Any of IMA 500, radial arteries 502, or greater saphenous veins 506, or other harvest sites (not shown) may be potential harvest vessels for use in a CABG procedure.
  • processing circuitry 204 may, based on imaging data 214, determine one or more recommended graft location(s) 302.
  • a recommended graft location may include at least one of a recommended graft origin 306, a recommended graft path 310, or a recommended graft termination 308.
  • processing circuitry 204 may determine an appropriate length of a harvest vessel segment for the recommended graft based on the graft location.
  • processing circuitry 204 may determine an appropriate diameter (e.g., inner diameter) of a harvest vessel segment to be used for the graft based on the diameter (e.g., inner diameter) of the occluded vessel the graft is meant to bypass. Processing circuitry 204 may use the information of determined length and diameter to attempt to find an appropriate segment of a harvest vessel to be used for the graft. For example, processing circuitry 204 may use imaging data 214 of potential harvest vessels to identify a vessel segment of a potential harvest vessel having an appropriate length and diameter for use as in the graft.
  • an appropriate diameter e.g., inner diameter
  • Processing circuitry 204 may attempt to identify bifurcations or other structural features in the potential harvest vessels which may make some segments less desirable to use so as to avoid the use, when possible, of such segments.
  • the techniques of this disclosure may be utilized even when a harvest procedure is not part of the CABG procedure. For example, a clinician may use one or more artificial, cadaveric, or animal vessels for the CABG procedure, rather than, or in addition to, one or more harvest vessels from the patient.
  • FIG. 6 is a conceptual diagram illustrating different example surgical access techniques.
  • processing circuitry 204 may recommend a surgical access strategy, for example, based on graft location(s) 302.
  • Surgical access strategy 600 may include a median sternotomy and may provide the greatest access and/or visibility into the region of the patient where the graft will be located. However, surgical access strategy 600 may involve cutting completely through the sternum vertically to open up the entire chest cavity. Surgical access strategy 600 may therefore be considered a relatively highly invasive procedure and generally requires a longer recovery period for the patient than the other potential surgical access strategies.
  • processing circuitry 204 may recommend a different surgical access strategy, such as any of surgical access strategies 602, 604, or 606.
  • Surgical access strategy 602 may involve cutting partially through the sternum vertically and then making one or more lateral cuts across the sternum to open up a portion of the chest cavity (e.g., an upper portion of the chest cavity).
  • Surgical access strategy 604 may involve cutting partially through the sternum vertically and then making a single lateral cut to one side of the sternum to open up a portion of the chest cavity (e.g., an upper-left portion of the chest cavity).
  • Surgical access strategy 606 may completely avoid cutting the sternum, instead making an incision through tissue between the ribs to open up access only through the incision itself.
  • the examples of FIG. 6 are presented, generally, in order of greatest invasiveness/access/visibility with surgical access strategy 600 having the greatest invasiveness/access/visibility, followed by surgical access strategy 602, followed by surgical access strategy 604, and followed by surgical access strategy 606, having the least invasiveness/access/visibility.
  • processing circuitry 204 may recommend the least invasive surgery access strategy which may provide adequate access to perform the recommended graft as part of operating plan 300.
  • FIG. 7 is a conceptual diagram of an example 3D model of a heart according to one or more aspects of this disclosure.
  • 3D model 700 may be an example of one of 3D model(s) 232 of FIGS. 2-3.
  • Processing circuitry 204 may present 3D model 700 via user interface(s) 218 for example, on display 206, either as part of operating plan 300 or separately.
  • a clinician may interact with user interface(s) 218 to, for example, place clamp representation 702 and/or aortic root cannula representation 704 in preferred location(s) on a representation of the heart of the patient.
  • processing circuitry 204 may use the preferred location(s) as inputs to iterate on recommended graft location(s) and any associated harvest plans. For example, processing circuitry 204 may generate an updated plan including updated recommendation(s).
  • FIG. 8 is a conceptual diagram illustrating an example recommended graft location in accordance with one or more aspects of this disclosure.
  • the recommended graft location of FIG. 8 which may be an example of a recommended graft location of recommended graft location(s) 302, may include a recommended graft origin 800, a recommended graft termination 802, and a recommended graft path 804.
  • Recommended graft path 804 may avoid the pulmonary trunk and follow the contour of the heart surface while avoiding obstacles and connect the recommended graft origin 800 to recommended graft termination 802 to bypass the blockage.
  • FIG. 9 is a conceptual diagram illustrating an example harvested radial artery.
  • Harvested radial artery 900 may be an example of a segment of a radial artery harvested without the use of harvest plan 304.
  • harvested radial artery 900 may be harvested for use in two grafts. Once harvested, a clinician may cut harvested radial artery 900 for use in the two grafts.
  • Segment 902 may be designated for use in a first graft and segment 904 may be designated for use in a second graft.
  • segment 902 may include a clipped branch 908 (e.g., formerly a bifurcation) which may be undesirable in a graft.
  • a clipped branch 908 e.g., formerly a bifurcation
  • harvested radial artery 900 may be greater than necessary as harvested radial artery 900 has an arbitrary end point 906 where the clinician cut the radial artery during harvesting.
  • harvested radial artery 900 includes a wasted segment 910, which would have been better left in place in the arm of the patient. If harvest plan 304 had been used, the harvest plan may have set forth a better planned end point than arbitrary end point 906 and avoided recommending segment 902 for use in a graft due to clipped branch 908 or a bifurcation.
  • FIG. 10 is a conceptual diagram illustrating an example use of a 3D model generated based on imaging data other than CCTA imaging data in accordance with one or more aspects of this disclosure.
  • the techniques of this disclosure may be used with imaging data such as CCTA imaging data and/or other imaging data.
  • imaging data such as CCTA imaging data and/or other imaging data.
  • a patient may go to a Cath lab for a coronary angiography and/or percutaneous coronary intervention (PCI) due to the patient experiencing chest pain, fatigue, and/or the like.
  • PCI percutaneous coronary intervention
  • a clinician may discover that the patient is suffering from multivessel lesions. In such a case, the patient may then be referred to undergo a CABG procedure.
  • additional imager(s) 142 may include one or more imagers such as a FFR angiography imager. Additional imager(s) 142 may capture and/or perform an analysis of a whole coronary tree, including the RCA and LCA, at once by taking multiple angio images. Such a procedure may be easier and quicker than running a pressure wire through every potential lesion, like traditional FFR and/or instantaneous wave-free ratio (IFR).
  • IFR instantaneous wave-free ratio
  • System 100 may utilize imaging data 214 from other imager(s) 142, such as an FFR angiography imager, to generate a 3D model used to calculate FFR from angiography images.
  • system 100 may store such a 3D model in 3D model(s) 232.
  • system 100 may use the imaging data and/or the 3D model used to calculate FFR to generate one or more of 3D model(s) 232 and/or operating plan(s) 220, including a recommended graft origin, a recommended graft path, and a recommended graft termination.
  • system 100 may display user interface 1000, e.g., on display device 110, which may include a representation of the 3D model used to calculate FFR.
  • User interface 1000 may be an example of a user interface of user interface(s) 218 (FIG. 2).
  • User interface 1000 may include a user selectable button or icon 1002 which a clinician may select to invoke additional processing by system 100 to adapt (e.g., optimize) the 3D model for use by system 100 to generate operating plan(s) 220 for graft placement.
  • FIG. 11 is a conceptual diagram illustrating contents of another example operating plan in accordance with one or more aspects of this disclosure.
  • This additional processing step which may only take minutes, may, for example, be initiated by a clinician at any point, such as during a transfer from diagnostic to surgery, during a follow up exam, or the like.
  • the additional processing step may be initiated by a structural heart surgeon, rather than an interventional cardiologist, as the patient is being transferred from diagnostic to surgery and/or being prepared for surgery using the already captured images (e.g., imaging data 214) instead of obtaining more images, such as CCTA images from imager 140.
  • this process can also be performed during a follow up appointment if the case is not severe enough to warrant a CABG the day the lesions are discovered, as imaging data 214 may already be stored within system 100.
  • additional images such as CCTA images, may be captured from imager 140 and/or additional imager(s) 142 by system 100 if desired for additional data which may be used to generate or alter any of 3D model(s) 232 and/or operating plan(s) 220.
  • harvest site information may not be available, for example, if only obtained coronary angiography imaging data is used.
  • generated operating plan(s) 220 may still incorporate recommendations, such as length and diameter(s) of harvest vessels to help aid a clinician in determining harvest sites, such as recommendation 1100 for a harvest vessel for use as a bypass vessel 1102. Additional information, such as a placement location into the diseased artery, as well as aortic placement may be included in operating plan(s) 220.
  • operating plan(s) 220 may include a recommended graft origin, a recommended graft path, and a recommended graft termination regardless of whether imaging data 214 includes CCTA imaging data, FFR angiography imaging data, or other imaging data.
  • the techniques described in this disclosure may be implemented, at least in part, in hardware, software, firmware or any combination thereof.
  • various aspects of the described techniques may be implemented within one or more processors or processing circuitry, including one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), or any other equivalent integrated or discrete logic circuitry, as well as any combinations of such components.
  • DSPs digital signal processors
  • ASICs application specific integrated circuits
  • FPGAs field programmable gate arrays
  • Such hardware, software, and firmware may be implemented within the same device or within separate devices to support the various operations and functions described in this disclosure.
  • any of the described units, circuits or components may be implemented together or separately as discrete but interoperable logic devices. Depiction of different features as circuits or units is intended to highlight different functional aspects and does not necessarily imply that such circuits or units must be realized by separate hardware or software components. Rather, functionality associated with one or more circuits or units may be performed by separate hardware or software components or integrated within common or separate hardware or software components.
  • Computer readable medium such as a computer-readable storage medium, containing instructions. Instructions embedded or encoded in a computer-readable storage medium may cause a programmable processor, or other processor, to perform the method, e.g., when the instructions are executed.
  • Computer readable storage media may include random access memory (RAM), read only memory (ROM), programmable read only memory (PROM), erasable programmable read only memory (EPROM), or electronically erasable programmable read only memory (EEPROM), or other computer readable media.
  • Example 1 A medical system comprising: memory configured to store an operating plan for a coronary artery bypass graft (CABG) procedure; and processing circuitry communicatively coupled to the memory, the processing circuitry being configured to: obtain input data, the input data comprising imaging data of vasculature of a patient; determine, based on the input data, the operating plan, the operating plan comprising at least one recommended graft location, the recommended graft location including a recommended graft origin, a recommended graft path, and a recommended graft termination; and output, for display, the operating plan.
  • CABG coronary artery bypass graft
  • Example 2 The medical system of example 1, wherein the at least one recommended graft location comprises a recommended graft location for proximal anastomosis to an aorta.
  • Example 3 The medical system of example 1 or 2, wherein the at least one recommended graft location comprises a recommended graft location for distal anastomosis distal to a coronary obstruction.
  • Example 4 The medical system of any of examples 1-3, wherein the recommended graft path comprises a path between the recommended graft origin and the recommended graft termination, the recommended graft path being configured to avoid any obstacles between the recommended graft origin and the recommended graft termination.
  • Example 5 The medical system of any of examples 1-4, wherein the operating plan further comprises at least one recommended vessel edge condition of a vessel to be used for a graft.
  • Example 6 The medical system of example 5, wherein the at least one recommended vessel edge condition comprises at least one cut angle.
  • Example 7 The medical system of any of examples 1-6, wherein the processing circuitry is further configured to determine one or more recommended harvest vessel segment lengths based, at least in part, on the at least one recommended graft location, and wherein the operating plan further comprises the one or more recommended harvest vessel segment lengths.
  • Example 8 The medical system of example 7, wherein the processing circuitry is further configured to determine at least one recommended harvest vessel segment, the at least one recommended harvest vessel segment being based, at least in part, on the one or more recommended harvest vessel segment lengths, and a recommended harvest vessel anatomy, and wherein the operating plan further comprises a harvest plan, the harvest plan comprising an identification of the at least one recommended harvest vessel segment.
  • Example 9 The medical system of example 8, wherein the recommended harvest vessel anatomy comprises a recommended harvest vessel diameter, the recommended harvest vessel diameter being based on a diameter of an obstructed vessel.
  • Example 10 The medical system of any of examples 1-9, wherein the processing circuitry is further configured to: obtain user input associated with the operating plan; amend the operating plan based on the user input to generate an amended operating plan; and output, for display, the amended operating plan.
  • Example 11 The medical system of any of examples 1-10, wherein the imaging data comprises coronary computed tomography angiogram (CCTA) imaging data.
  • CCTA coronary computed tomography angiogram
  • Example 12 The medical system of any of examples 1-11, wherein the imaging data comprises angiogram imaging data.
  • Example 13 The medical system of any of examples 1-12, wherein the imaging data comprises fractional flow reserve (FFR) angiogram imaging data.
  • Example 14 The medical system of any of examples 1-13, wherein as part of determining the operating plan, the processing circuitry is configured to determine a three-dimensional model based on the input data.
  • FFR fractional flow reserve
  • Example 15 The medical system of any of examples 1-14, wherein the imaging data comprises at least one of imaging data of at least one blocked vessel or imaging data of at least one potential harvest vessel.
  • Example 16 The medical system of any of examples 1-15, wherein the input data further comprises at least one of information relating to at least one potential harvest vessel, a measure or an estimate of coronary perfusion pressure (CPP), or an indication of whether the CABG procedure is a robotic assisted procedure.
  • CPP coronary perfusion pressure
  • Example 17 The medical system of any of examples 1-16, wherein the processing circuitry is further configured to determine at least one of an estimate for saphenous vein graft (SVG) support, one or more recommendations for dissecting an internal mammary artery (IMA) graft from a chest wall, or one or more recommendations of a robotic assisted surgical approach, and wherein the operating plan further comprises at least one of the estimate for SVG support, the one or more recommendations for dissecting thelMA graft from a chest wall, or the one or more recommendations of the robotic assisted surgical approach.
  • SVG saphenous vein graft
  • IMA internal mammary artery
  • Example 18 The medical system of any of examples 1-17, wherein the processing circuitry is further configured to determine an estimate of flow restoration based on at least one of the recommendations, and wherein at least one of the operating plan further comprises a representation of the estimate of flow restoration.
  • Example 19 The medical system of any of examples 1-18, wherein the processing circuitry is further configured to determine at least one of recommended robotic positioning, at least one recommended access location on the patient, or at least one target output for robotic anastomosis, and wherein the operating plan comprises at least one of the recommended robotic positioning, the at least one recommended access location on the patient, or the at least one target output for robotic anastomosis.
  • Example 20 A method comprising: obtaining, by processing circuitry, input data, the input data comprising imaging data of vasculature of a patient; determining, by the processing circuitry and based on the input data, an operating plan, the operating plan comprising at least one recommended graft location, the recommended graft location including a recommended graft origin, a recommended graft path, and a recommended graft termination; and outputting, by the processing circuitry and for display, the operating plan.
  • Example 21 The method of example 20, wherein the at least one recommended graft location comprises a recommended graft location for proximal anastomosis to an aorta.
  • Example 22 The method of example 20 or 21, wherein the at least one recommended graft location comprises a recommended graft location for distal anastomosis distal to a coronary obstruction.
  • Example 23 The method of any of examples 20-22, wherein the recommended graft path comprises a path between the recommended graft origin and the recommended graft termination, the recommended graft path being configured to avoid any obstacles between the recommended graft origin and the recommended graft termination.
  • Example 24 The method of any of examples 20-23, wherein the operating plan further comprises at least one recommended vessel edge condition of a vessel to be used for a graft.
  • Example 25 The method of example 24, wherein the at least one vessel edge condition comprises at least one cut angle.
  • Example 26 The method of any of examples 20-25, further comprising determining, by the processing circuitry, one or more recommended harvest vessel segment lengths based, at least in part, on the at least one recommended graft location, and wherein the operating plan further comprises the one or more recommended harvest vessel segment lengths.
  • Example 27 The method of example 26, further comprising determining, by the processing circuitry, at least one recommended harvest vessel segment, the at least one recommended harvest vessel segment being based, at least in part, on the one or more recommended harvest vessel segment lengths, and a recommended harvest vessel anatomy, and wherein the operating plan further comprises a harvest plan, the harvest plan comprising an identification of the at least one recommended harvest vessel segment.
  • Example 28 The method of example 27, wherein the recommended harvest vessel anatomy comprises a recommended harvest vessel diameter, the recommended harvest vessel diameter being based on a diameter of an obstructed vessel.
  • Example 29 The method of any of examples 20-28, further comprising: obtaining, by the processing circuitry, user input associated with the operating plan; amending, by the processing circuitry, the operating plan based on the user input to generate an amended operating plan; and outputting, by the processing circuitry and for display, the amended operating plan.
  • Example 30 The method of any of examples 20-29, wherein the imaging data comprises coronary computed tomography angiogram (CCTA) imaging data.
  • CCTA coronary computed tomography angiogram
  • Example 31 The method of any of examples 20-30, wherein the imaging data comprises angiogram imaging data.
  • Example 32 The method of any of examples 20-31, wherein the imaging data comprises fractional flow reserve (FFR) angiogram imaging data.
  • FFR fractional flow reserve
  • Example 33 The method of any of examples 20-32, wherein determining the operating plan comprises determining a three-dimensional model based on the input data.
  • Example 34 The method of any of examples 20-33, wherein the imaging data comprises at least one of imaging data of at least one blocked vessel or imaging data of at least one potential harvest vessel.
  • Example 35 The method of any of examples 20-34, wherein the input data further comprises at least one of information relating to at least one potential harvest vessel, a measure or an estimate of coronary perfusion pressure (CPP), or an indication of whether a CABG procedure is a robotic assisted procedure.
  • CPP coronary perfusion pressure
  • Example 36 The method of any of examples 20-35, further comprising determining, by the processing circuitry, at least one of an estimate for saphenous vein graft (SVG) support, one or more recommendations for dissecting an internal mammary artery (IMA) graft from a chest wall, or one or more recommendations of a robotic assisted surgical approach, and wherein the operating plan further comprises at least one of the estimate for SVG support, the one or more recommendations for dissecting the IMA graft from a chest wall, or the one or more recommendations of the robotic assisted surgical approach.
  • SVG saphenous vein graft
  • IMA internal mammary artery
  • Example 37 The method of any of examples 20-36, further comprising determining, by the processing circuitry, an estimate of flow restoration based on at least one of the recommendations, and wherein at least one of the operating plan further comprises a representation of the estimate of flow restoration.
  • Example 38 The method of any of examples 20-37, further comprising determining, by the processing circuitry, at least one of recommended robotic positioning, at least one recommended access location on the patient, or at least one target output for robotic anastomosis, and wherein the operating plan comprises at least one of the recommended robotic positioning, the at least one recommended access location on the patient, or the at least one target output for robotic anastomosis.
  • Example 39 A non-transitory computer-readable storage medium storing instructions, which, when executed, cause processing circuitry to: obtain input data, input data comprising imaging data of vasculature of a patient; determine, based on the input data, an operating plan, the operating plan comprising at least one recommended graft location, the recommended graft location including a recommended graft origin, a recommended graft path, and a recommended graft termination; and output, for display, the operating plan.

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Abstract

Example systems and techniques are disclosed that may generate a CABG procedure operating plan. An example system may include memory configured to store an operating plan for a coronary artery bypass graft (CABG) procedure and processing circuitry communicatively coupled to the memory. The processing circuitry is configured to obtain input data, the input data comprising imaging data of vasculature of a patient. The processing circuitry is configured to determine, based on the input data, the operating plan, the operating plan including at least one recommended graft location, the recommended graft location including a recommended graft origin, a recommended graft path, and a recommended graft termination. The processing circuitry is configured to output, for display, the operating plan.

Description

CORONARY ARTERY BYPASS GRAFT OPERATING PLAN
[0001] This application claims the benefit of U.S. Provisional Application No. 63/486,803, filed February 24, 2023, and entitled, “CORONARY ARTERY BYPASS GRAFT OPTIMIZATION.”
TECHNICAL FIELD
[0002] This disclosure relates to the coronary artery bypass graft (CABG) procedure planning.
BACKGROUND
[0003] A CABG procedure is a medical procedure in which one or more vessels or portions thereof may be harvested from a patient and grafted to anatomy of a patient to bypass an occluded artery of the patient and improve blood flow to the anatomy. The need for a CABG procedure may be determined by a clinician based on imaging data of a patient from an imaging system, such as a coronary computed tomography angiography (CCTA) imaging system or other imaging system, and/or other testing which may be undertaken by the clinician after presentation of coronary symptoms. CABG procedures are typically performed based on general rules for general patient populations.
SUMMARY
[0004] In general, this disclosure is directed to various techniques and medical systems for generating an operating plan for a CABG procedure based on patient-specific data. For example, a medical system may use image data (e.g., CCTA image data and/or other image data, such as angiography or fractional flow reserve (FFR) angiography data) of vasculature of a particular patient and/or other patient-specific information, to determine recommendation(s) for graft locations, routing of a graft vessel, harvest location, harvest vessel length(s), and/or the like. The medical system may present such recommendation(s) to a clinician in an operating plan. The clinician may use such recommendations to assist the clinician during a CABG procedure. The operating plan may include recommended graft locations(s), length(s) and diameter(s) of recommended graft(s), graft (e.g., harvest) vessel edge conditions (such as angle of cut, taper, etc.), recommended harvest vessel segments, recommended surgical access options to access anatomy of the patient, and/or the like. Because the anatomy of each patient may be different, a patient-specific operating plan may provide for better matching of donor vessel diameter to original blocked anatomy, better matching of harvested vessel segment length to length needed for the CABG procedure, and the like, than through the use of general rules based on the general population. The techniques of this disclosure may improve patient outcomes by improving graft patency, reducing or minimizing harvest waste, reducing blood supply loss at harvest site(s), reducing or minimizing procedural time, and reducing or otherwise improving patient recovery time.
[0005] In some examples, the medical system may provide the clinician with an opportunity to edit the recommendations to the clinician’s liking. For example, if the clinician would like to route a graft vessel in a different manner than recommended by the medical system, the clinician may use a user interface to edit the recommendation.
[0006] The techniques of this disclosure may provide for the more precise manner of determining location of grafts, which vessel segments to harvest, how much vessel to harvest, or the like for CABG procedures for a given patient via generation of a patientspecific operating plan, than conventional general population-based approach. In view of the above, the present disclosure describes a technological improvement or a technical solution that is integrated into a practical application.
[0007] Unlike conventional medical systems, the techniques and systems of this disclosure may obtain input data, including imaging data of vasculature of a patient, determine an operating plan including a recommended location for a graft, and output the operating plan to a display. By basing a recommendation for a graft location on imaging data relevant to an individual patient, the techniques and systems of this disclosure may facilitate improved CABG procedures, improved identification of harvest vessel segments of appropriate length, diameter, and/or other characteristics for use as a graft, etc., thereby improving patient outcomes.
[0008] In one example, a medical system includes: memory configured to store an operating plan for a coronary artery bypass graft (CABG) procedure; and processing circuitry communicatively coupled to the memory, the processing circuitry being configured to: obtain input data, the input data comprising imaging data of vasculature of a patient; determine, based on the input data, the operating plan, the operating plan comprising at least one recommended graft location, the recommended graft location including a recommended graft origin, a recommended graft path, and a recommended graft termination; and output, for display, the operating plan. [0009] In another example, a method includes: obtaining, by processing circuitry, input data, the input data comprising imaging data of vasculature of a patient; determining, by the processing circuitry and based on the input data, an operating plan, the operating plan comprising at least one recommended graft location, the recommended graft location including a recommended graft origin, a recommended graft path, and a recommended graft termination; and outputting, by the processing circuitry and for display, the operating plan.
[0010] In another example, a non-transitory computer readable medium stores instructions, which, when executed, cause processing circuitry to: obtain input data, input data comprising imaging data of vasculature of a patient; determine, based on the input data, the operating plan, the operating plan comprising at least one recommended graft location, the recommended graft location including a recommended graft origin, a recommended graft path, and a recommended graft termination; and output, for display, the operating plan.
[0011] These and other aspects of the present disclosure will be apparent from the detailed description below. In no event, however, should the above summaries be construed as limitations on the claimed subject matter, which subject matter is defined solely by the attached claims.
[0012] This summary is intended to provide an overview of the subject matter described in this disclosure. It is not intended to provide an exclusive or exhaustive explanation of the apparatus and methods described in detail within the accompanying drawings and description below. Further details of one or more examples are set forth in the accompanying drawings and the description below.
BRIEF DESCRIPTION OF DRAWINGS
[0013] FIG. l is a schematic perspective view of an example medical system according to one or more aspects of this disclosure.
[0014] FIG. 2 is a block diagram of an example of a computing device in accordance with one or more aspects of this disclosure.
[0015] FIG. 3 is a block diagram illustrating contents of an example operating plan in accordance with one or more aspects of this disclosure.
[0016] FIG. 4. is a flow diagram illustrating example CABG operating plan techniques according to one or more aspects of this disclosure. [0017] FIG. 5 is a conceptual diagram illustrating example potential harvest vessels according to one or more aspects of this disclosure.
[0018] FIG. 6A-D is a conceptual diagram illustrating different example surgical access techniques.
[0019] FIG. 7 is a conceptual diagram of an example three-dimensional (3D) model of a heart according to one or more aspects of this disclosure.
[0020] FIG. 8 is a conceptual diagram illustrating an example recommended graft location in accordance with one or more aspects of this disclosure.
[0021] FIG. 9 is a conceptual diagram illustrating an example harvested radial artery. [0022] FIG. 10 is a conceptual diagram illustrating an example use of a 3D model generated based on imaging data other than CCTA imaging data in accordance with one or more aspects of this disclosure.
[0023] FIG. 11 is a conceptual diagram illustrating contents of another example operating plan in accordance with one or more aspects of this disclosure.
DETAILED DESCRIPTION
[0024] CABG procedures are performed in relatively high volumes globally, with approximately 340,000 in the United States of America per year alone. However, such CABG procedures do not appear to include much patient-specific planning in advance of the CABG procedures themselves. CABG procedures are usually performed within a short window after acute symptoms are detected (e.g., within 48 hours) and clinicians, such as surgeons, tend to follow general guidelines for such CABG procedures applicable to the general population. In some cases, following guidelines applicable to the general population may make sense because patient-specific analysis may take time to perform, and performing the CABG procedure sooner rather than later may be better for the patient.
[0025] However, as patient scans, such as coronary computed tomography angiography (CCTA), become more sophisticated, processor technology decreases computational time, and software becomes increasingly available within the hospital itself, patient-specific CABG planning may be desirable, as patient-specific CABG planning may lead to better patient outcomes.
[0026] For example, patient-specific CABG planning solutions that match vessels that may be harvested to the native anatomy could help with graft patency, reducing or minimizing harvest waste, and reducing or minimizing planning and procedural time. Such improvements may increase the quality of patient outcomes.
[0027] For example, the techniques of this disclosure may include processing circuitry and/or software that interacts with patient scans (e.g., imaging data) and/or clinician input to generate an operating plan for CABG procedures. The operating plan may include recommended graft locations(s), length(s) and diameter(s) of recommended graft(s), recommended harvest vessel segments, recommended entry options to access anatomy of the patient, and/or the like. For example, the operating plan may include a harvest site plan including a length of segment(s) of vessel(s) required for the CABG procedure, a suggested (e.g., optimal) segment of the vessel for each bypass, corresponding bypass pathways, and/or an indication of a need for saphenous vein graft (SVG) support if applicable. The operating plan may include estimate(s) of flow restoration (e.g., distal segments restored and/or bypass comparison to an obstructed vessel). The operating plan may include robotic positioning and access location(s) if applicable. Targeting outputs for the robot for anastomosis may also be generated and included.
[0028] In some examples, such an operating plan may provide a clinician with advanced knowledge of potential case difficulties (e.g., graft length required, robotic articulation limitations, vessel condition, etc.) which may not be available if the clinician is utilizing a generalized population-based approach for the CABG procedure. The use of such an operating plan by a clinician may result in improved blood flow in the patient due to minimized graft length and improved diameter matching between the occluded vessel and the grafted (e.g., harvested) vessel, and/or reduced blood supply loss to the harvest site.
[0029] As case data is collected over time, the software may be updated to improve the efficacy of operating plans the software may generate. The use of such an operating plan may save time in the operating room by reducing the time a clinician may take to select, cut and/or position a vessel for grafting. For example, the software may include a computer vision algorithm which may be trained to recognize vessels and characteristics thereof, such as diameter (e.g., inner diameter), length, identity of the vessel, whether the vessel is occluded, bifurcations of a vessel or lack thereof, and/or the like. The computer vision algorithm may also be trained to recognize contours of anatomy, such as the heart, structures of the heart, potential obstacles to be avoided when determining a recommended graft path, or the like. [0030] The length, diameter, and location of a blood vessel makes a significant difference in the resultant flow. Currently many clinicians favor a “one-size-fits-all” approach (e.g., an approach based on the general population) due to the urgency and criticality of a CABG procedure, but it is unlikely that this approach is truly ideal for all patients. Currently, a clinician may consider a combination of a number of factors when planning a CABG procedure. A clinician may consider which sites are available for harvest of a vessel. Typically, graft vessels are harvested from any of, or any combination of, three locations: a radial artery, an internal mammary artery (IMA), or a saphenous sein (SVG). Some of the possible harvest sites may be compromised from previous surgery, patient condition, or natural differences across patient anatomy. Bifurcations and/or branches at certain intervals of a potential harvest vessel may make the use of some vessel sections or segments difficult to use for grafting. With conventional CABG techniques, a clinician may not be aware of such bifurcations and/or branches prior to beginning the CABG procedure (e.g., prior to harvesting).
[0031] A clinician may consider the size of the occluded artery. It may be important to understand the length and diameter of the artery being replaced when performing a CABG procedure to ensure adequate blood flow is restored to the patient by the CABG procedure. For example, using a substantially narrower vessel segment (e.g., a vessel segment with a substantially lower inner diameter) than the occluded vessel as a graft, may not provide adequate blood flow. A clinician may consider which type of graft may most closely match the native blood flow in the patient. Currently, such a consideration is primarily determined by “rule-of-thumb.” For example, the American College of Cardiology describes the following. For left anterior descending artery (LAD) obstructions, choose left internal mammary artery (LIMA) first as a harvest vessel, if possible, then go to right internal mammary artery (RIMA). Use an internal mammary artery (IMA) for left circumflex coronary artery (LCX) and right coronary artery (RCA) if the RCA has greater than 90% stenosis. A left-sided artery may be bypassed with a radial artery if there is greater than 70% stenosis, and a right-sided artery may be bypassed with a radial artery if there is greater than 90% stenosis. The general patency from best to worst over time is set forth as IMA, then radial artery, then SVG.
[0032] A clinician may consider a number of bypasses that may be required. It is not unusual for multiple critical obstructions to be discovered simultaneously. As such, a clinician may desire to understand how a plurality of grafts may affect each other. [0033] A clinician may consider, if choosing SVG, any concerns with remodeling of the grafted vessel. Currently, SVG is the most common graft in the world due to the relative ease of harvest and working length of the vessel. Some of the SVG patency concerns appear to be linked to remodeling over time. The cause of the remodeling relates to the difference in arterial pressures and veinous pressures. In some examples, remodeling may be mitigated by a particular surgical technique or by adding device support to the SVG.
[0034] These factors and others may be processed by the clinician shortly before the CABG procedure or during the CABG procedure itself, in the most critical cases. As can be seen, these factors are numerous and may be complicated, even when applied based on a general population model. When attempting to plan a CABG procedure including patient-specific factors, such planning may be too complicated to be accomplished in a human brain. The stress associated with a quick turnaround or emergency procedure may further complicate such planning.
[0035] In conjunction with graft planning, the clinician may also consider a graft location. The distal graft connection should generally be made distal to a coronary blockage and should generally remain close to where the blockage ends to maximize the amount of revascularization. Additionally, the clinician may consider the proximal attachment location on the aorta of the grafted vessel. For example, based on how blood is supplied to the coronary arteries (e.g., diastole flow from the aorta), a clinician may consider making the proximal attachment as inferior on the Aortic root as possible. This is also supported by the natural right coronary artery (RCA) and left coronary artery (LCA) ostia. Additionally, the clinician may desire that the grafted vessel follow the contour of the heart with limited tension, slack and wasted length. For example, excess graft length may increase the chance of poor flow, e.g., due to kinking risk, dead zones, frictional losses, or the like.
[0036] Currently, surgical access is typically accomplished via full or partial sternotomy or thoracotomy. In general, more access may make for an easier and quicker anastomosis (e.g., connection between adjacent blood vessels) for the surgeon, but increases recovery time (which may increase hospital costs and occupancy), the potential for complications, and pain for the patient. Some graft locations, or a combination of grafts, could preclude minimally invasive operations based on surgeon reach and visualization. [0037] It should be noted that some CABG procedures, including robotic assisted surgeries, may be accomplished through incisions between the ribs without the need for a sternotomy. Therefore, in some examples, it may be desirable to plan out graft location balanced with access, such as robotic manipulator reach, for example, in non-emergent cases.
[0038] FIG. l is a schematic perspective view of an example medical system according to one or more aspects of this disclosure. Medical system 100 may include imager 140 (which may be a CCTA imager), display device 110, table 120, additional imager(s) 142, computing device 150, network 156, and server 160. In some examples, fewer or more components of medical system 100 may exist.
[0039] Medical system 100 may be used to for a medical procedure, such as a CABG procedure. Medical system 100 may generate and display an operating plan for the CABG procedure according to the techniques of this disclosure. For example, computing device 150 and/or server 160 may generate an operating plan including at least one recommended graft location. The recommended graft location may include a recommended graft origin, a recommended graft path, and a recommended graft termination. Medical system 100 may display the operating plan for viewing by a clinician, for example, on display device 110. Such a medical system may facilitate a clinician to make better informed decisions prior to or during the CABG procedure which may improve graft patency, reduce or minimize harvest waste, reduce blood supply loss at harvest site(s), reduce or minimize procedural time, and reduce or otherwise improve patient outcomes, including recovery time.
[0040] Medical system 100 may be an example of a medical system for use in a surgical ward, a catheterization laboratory (Cath lab), or other healthcare environment. In some examples, medical system 100 may include other devices. In some examples, medical system 100 may be used during a medical procedure, such as a CABG procedure. In some examples, system 100 may be used during a diagnostic session to diagnose cardiovascular issues for a patient.
[0041] Computing device 150 may include, for example, an off-the-shelf device, such as a laptop computer, desktop computer, tablet computer, smart phone, or other similar device. In other examples, computing device 150 may be a special purpose computing device, such as one specifically designed to be used in medical system 100. Computing device 150 includes memory and processing circuitry. [0042] In some examples, computing device 150 may be configured to control a robotic medical device, an electrosurgical generator, a peristaltic pump, a power supply, or any other accessories and peripheral devices relating to, or forming part of, medical system 100. In some examples, computing device 150 may perform various control functions with respect to imager 140, additional imager(s) 142, display device 110, additional equipment 152, and/or the like. Computing device 150 may be communicatively coupled to imager 140, additional imager(s) 142, one or more devices of additional equipment 152, display device 110, server 160, and/or network 156.
[0043] While a number of features are described herein as being attributed to computing device 150, in some examples, features attributed to computing device 150 may be performed by processing circuitry of any of computing device 150, imager 140, server 160, network 156 (e.g., one or more computing devices forming or connected to network 156), other elements of medical system 100, or any combinations thereof. In some examples, processing circuitry associated with computing device 150 may be distributed and shared across any combination of computing device 150, imager 140, server 160, network 156, display device 110, additional equipment 152, and/or other elements of medical system 100. Additionally, in some examples, processing operations or other operations performed by processing circuitry of computing device 150 may be performed by processing circuitry residing remotely, such as one or more cloud servers or processors. For purposes of ease of discussion herein, such processing circuitry may be considered a part of computing device 150.
[0044] Medical system 100 may include network 156, which is a suitable network such as a local area network (LAN) that includes a wired network or a wireless network, a wide area network (WAN), a wireless mobile network, a Bluetooth network, or the Internet. In some examples, network 156 may be a secure network, such as a hospital network, which may limit access by users. In some examples, network 156 may interconnect various devices of medical system 100.
[0045] Imager 140 may be a CCTA imager, and may image portions of a patient’s body, such as the area around or about the heart of the patient and areas having potential harvest vessels, during or before a medical procedure to visualize characteristics and locations of one or more occluded vessels to be bypassed, locations of potential grafts, anatomy of the patient in the area of the heart, characteristics and locations of potential harvest vessels, and/or the like. Additional imager(s) 142 may also be configured to image portions of a patient’s body, such as a cardiac vasculature of the patient. In some examples, additional imager(s) 142 may include one or more devices other than a CCTA imager, such as an angiography device (e.g., a fractional flow reserve (FFR) angiography device, ultrasound device (e.g., with an external probe, an intravenous probe, etc.), a fluoroscopy device, an optical coherence tomograph (OCT) device, a near infrared spectroscopy (NIRS) device, a magnetic resonance imaging (MRI) device, a positron emission tomography (PET) device, or the like. Additional imager(s) 142 may capture detail of the anatomy of the patient that may not be captured by imager 140 which may be used to update and/or provide further details for the operating plan. In some examples, additional imager(s) 142 may capture imaging data of the patient prior to the CABG procedure, e.g., during the same visit to the facility as for the CABG procedure, during a different visit to the facility, or a visit to another facility. In some examples, additional imager(s) 142 may capture imaging data of the patient during the CABG procedure. [0046] In some examples, computing device 150 may be configured to obtain clinician input, such as through a user interface, which computing device 150 may use to iterate the operating plan. For example, the clinician may input a graft angle preference, change a location of a recommended graft, change a desired harvest vessel, or the like. Computing device 150 may then update the operating plan based on the clinician input. [0047] Computing device 150 may be configured to execute a computer vision algorithm to determine the operating plan or portions thereof, such as to determine recommended graft locations, determine recommended harvest segments, and/or to generate a three-dimensional (3D) model of the heart and surrounding vascular tissue. [0048] According to the techniques of this disclosure, computing device 150 may obtain input data, the input data comprising imaging data of vasculature of a patient. For example, computing device 150 may obtain imaging data from imager 140 and/or additional imager(s) 142. Computing device 150 may determine, based on the input data, an operating plan, the operating plan comprising at least one recommended graft location, the recommended graft location including a recommended graft origin, a recommended graft path, and a recommended graft termination. Computing device 150 may output, for display, the operating plan. For example, computing device may output the operating plan to display device 110 for display such that a clinician may view the operating plan. [0049] Additional equipment 152 may include devices configured to be used during a medical procedure, such as a CABG procedure, including, but not limited to, clamps, forceps, scissors, a cardiopulmonary bypass machine, tubing, SVG support devices, or the like. [0050] Display device 110 may be configured to display captured imaging data, from, for example, imager 140 and/or additional imager(s) 142. In some examples, display device 110 may be configured to display a 3D model of the coronary vasculature of a patient (which may be part of an operating plan), instead of or in addition to captured imaging data. In some examples, display device 110 may be configured to display the various user interfaces disclosed herein. In some examples display device 110 may be configured to display an operating plan and/or revised operating plan as disclosed herein. Display device 110 may be configured to display any other content discussed as being displayed in this disclosure.
[0051] Table 120 may be, for example, an operating table or other table suitable for use during a medical procedure, such as a CABG procedure. Although depicted as being in the same environment as imager 140, in some examples, table 120 may not be a same environment as imager 140.
[0052] Server 160 may be configured to store data obtained by and/or determined or generated by computing device 150. In some examples, server 160 may be configured to perform techniques attributed to computing device 150. Server 160 may be communicatively coupled to computing device 150, for example, by wired, optical, or wireless communications and/or by network 156. Server 160 may be a hospital server which may or may not be located in an operating room, such as a cloud-based server, or the like. Server 160 may be configured to store patient data, electronic patient records, or the like.
[0053] FIG. 2 is a block diagram of an example of a computing device in accordance with one or more aspects of this disclosure. Computing device 200 may be an example of computing device 150, a computing device of network 156, and/or server 160 of FIG. 1 and may include a workstation, a desktop computer, a laptop computer, a server, a smart phone, a tablet, a dedicated computing device, or any other computing device capable of performing the techniques of this disclosure.
[0054] In some examples, computing device 200 may be configured to perform processing, control and other functions associated with various devices of FIG. 1, such as display device 110, imager 140, additional imager(s) 142, and/or additional equipment 152. Computing device 200 may include, for example, a memory 202, processing circuitry 204, a display 206, a network interface 208, an input device(s) 210, or an output device(s) 212, each of which may represent any of multiple instances of such a device within the computing system, for ease of description. [0055] While processing circuitry 204 appears in computing device 200 in FIG. 2, in some examples, features attributed to processing circuitry 204 may be performed by processing circuitry of any of computing device 150, imager 140, server 160, computing devices of network 156, or other components of FIG. 1. In some examples, one or more processors associated with processing circuitry 204 in computing device 200 may be distributed and shared across any combination of computing device 150, imager 140, server 160, computing devices of network 156, or other components of FIG. 1. Additionally, in some examples, processing operations or other operations performed by processing circuitry 204 may be performed by one or more processors residing remotely, such as one or more cloud servers or processors, each of which may be considered a part of computing device 200. Computing device 200 may be used to perform any of the techniques described in this disclosure, and may form all or part of devices or systems configured to perform such techniques, alone or in conjunction with other components, such as components of computing device 150, imager 140, server 160, computing devices of network 156, other components of FIG. 1, or a system including any or all of such devices.
[0056] Memory 202 of computing device 200 includes any non-transitory computer- readable storage media for storing data or software that is executable by processing circuitry 204 and that controls the operation of computing device 150. In one or more examples, memory 202 may include one or more solid-state storage devices such as flash memory chips. In one or more examples, memory 202 may include one or more mass storage devices connected to the processing circuitry 204 through a mass storage controller (not shown) and a communications bus (not shown).
[0057] Although the description of computer-readable media herein refers to a solid- state storage, it should be appreciated by those skilled in the art that computer-readable storage media may be any available media that may be accessed by the processing circuitry 204. That is, computer readable storage media includes non-transitory, volatile and non-volatile, removable and non-removable media implemented in any method or technology for storage of information such as computer-readable instructions, data structures, program modules, or other data. For example, computer-readable storage media includes RAM, ROM, EPROM, EEPROM, flash memory or other solid state memory technology, CD-ROM, DVD, Blu-Ray or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium that may be used to store the desired information and that may be accessed by computing device 200. In one or more examples, computer-readable storage media may be stored in the cloud or remote storage and accessed using any suitable technique or techniques through at least one of a wired or wireless connection.
[0058] Memory 202 may store computer vision algorithm 224. Computer vision algorithm 224 may be trained using imaging data collected from past medical procedures and/or user input data. Memory 202 may also store user interface(s) 218. User interface(s) 218 may include one or more user interfaces which processing circuitry 204 may output for display by display 206 and/or display device 110. For example, a clinician may interact with user interface(s) 218 to provide input data for use by processing circuitry 204 to generate, update, or modify an operating plan.
[0059] Memory 202 may store imaging data 214, operating plan(s) 220, electronic patient record 236, 3D model(s) 232. Imaging data 214 may be captured by imager 140 and/or additional imager(s) 142 (FIG. 1) during a medical procedure of a patient.
Processing circuitry 204 may obtain imaging data 214 from imager 140 and/or additional imager(s) 142 and store imaging data 214 in memory 202. Processing circuitry 204 may use imaging data 214 to determine operating plan(s) 220, and/or the like. Processing circuitry 204 may use imaging data 214 to determine one or more 3D model(s) and/or update one or more 3D model(s) 232. Processing circuitry 204 may use information obtained from a clinician to iterate and update operating plan(s) 220.
[0060] Processing circuitry 204 may execute any of user interface(s) 218 so as to cause display 206 (and/or display device 110 of FIG. 1) to present that UI of user interface(s) 218 to one or more clinicians performing the medical procedure.
[0061] For example, processing circuitry 204 may obtain information indicative of one or more occluded arteries. For example, processing circuitry 204 may obtain, from imager 140, which may be a CCTA imager, data relating to current arterial blockages. Processing circuitry 204 may, additionally, or alternatively, obtain data relating to potential graft sites. For example, processing circuitry 204 may obtain, from imager 140, image data of potential graft sites, and/or obtain, from a user interface (e.g., input device(s) 210) or network interface 208, manually entered information relating to potential graft sites.
[0062] Processing circuitry 204 may obtain a Coronary Perfusion Pressure (CPP) or an estimate of the CPP, for example from a device of additional equipment 152. CPP may be a measure of a difference between aortic diastolic pressure and left ventricular end- diastolic pressure. Processing circuitry 204 may obtain clinician graft preferences, for example, from a user interface (e.g., input device(s) 210) or a network interface 208. Processing circuitry 204 may obtain an indication of whether the procedure is a robotic or robotic-assisted procedure, for example, from a user interface (e.g., input device(s) 210) or network interface 208.
[0063] Processing circuitry 204 may, from the obtained information/data, determine one or more suggested (e.g., optimal) locations for proximal anastomosis to the aorta, shortest graft path(s) to bypass the blockage or blockages, suggested suitable graft length(s) to accomplish total (or adequate) restoration of blood flow, suitable donor vessels as graft options based on blocked artery diameter and length required to restore flow, estimates for required SVG support (if it is possible to calculate based on available data) as sometimes SVG vein grafts may collapse, options to reach an IMA graft from the chest wall, an initial estimate for a robotic or robotic assisted surgical approach to minimize incision size, and/or the like. For example, processing circuitry 204 may generate an operating plan(s) 220 including any of or any combination of such information. Processing circuitry 204 may store operating plan(s) 220 in memory 202. Processing circuitry 204 may control a display device (e.g., display 206, display device 110, etc.) to display operating plan(s) 220 for a clinician to view.
[0064] In some examples, processing circuitry 204 may facilitate a clinician interacting with operating plan(s) 220. For example, processing circuitry 204 may allow a clinician, via a user interface(s) 218, input device(s) 210, and/or network interface 208, to confirm or modify Aorta and/or vessel anastomosis locations. Processing circuitry 204 may permit a clinician to review operating plan(s) 220 and any associated imaging data 214 to view potential bypass sites to ensure the potential bypass sites are free from plaque buildup or other potential obstructions. Processing circuitry 204 may permit the clinician to select a graft site location, which processing circuitry 204 may record in operating plan(s) 220. Processing circuitry 204 may permit a clinician to modify a robotic approach if so desired and store the modified approach in operating plan(s) 220.
[0065] After considering any clinician input, processing circuitry 204 may iterate on operating plan(s) 220 and generate a finalized operating plan. For example, processing circuitry 204 may base a finalized operating plan on the original operating plan and any clinician input. Processing circuitry 204 may store the finalized operating plan in operating plan(s) 220. The finalized operating plan of operating plan(s) 220 may include a harvest site plan including a length of segment(s) required for the CABG procedure, a suggested (e.g., optimal) segment of the harvest vessel for each bypass, corresponding bypass pathways, an indication of the need for SVG support, if applicable, and/or the like. The finalized operating plan of operating plan(s) 220 may include estimates of flow restoration (e.g., distal segments restored and bypass comparison to obstructed vessel). The finalized operating plan of operating plan(s) 220 may include robotic positioning and access location(s) if applicable and/or targeting outputs for the robot for anastomosis. [0066] For example, processing circuity 204 may control display 206, output device(s) 212, and/or display device 110, to display the operating plan (e.g., the finalized operating plan), for example, to provide real time guidance during a harvest portion and/or bypass portion of the CABG procedure. Display of the operating plan may assist a clinician in better understanding a harvest location, selecting an appropriate graft length, and determining the specific sections of the harvest vessels that are uninterrupted by branches. As such, the harvest operation of the CABG procedure may be expedited and blood supply loss to the harvest site may be reduced.
[0067] Display of the operating plan may assist a clinician in understanding the required length of an IMA graft and whether the IMA graft can reach past the blockage without tension. Thus, display of the operating plan may minimize (or reduce) the required length of vessel dissected from a chest wall of the patient.
[0068] Display of the operating plan may also assist the clinician in attaching the bypass grafts to the ideal (e.g., suggested) locations on the Aorta to prevent crowding and/or crossing of vessels while maximizing blood flow to impacted areas of the heart of the patient.
[0069] Processing circuitry 204 may assist the clinician in selecting the location(s) for aorta anastomosis. For example, processing circuitry 204 may identify the ascending aorta and pulmonary artery from imaging data 214, via execution of computer vision algorithm 224, which may be trained to identify such vessels. For example, it may be desirable for the graft to be attached as close to the aortic valve as possible so as to mimic native anatomy. However, it also may be desirable that the graft navigate around the pulmonary artery trunk without turning downward and risking poor blood flow.
[0070] For example, processing circuitry 204 may organize bypasses based on proximity to occlusions and assume an anterior sternotomy approach. In some examples, the origination point may be adjusted by the clinician following an initial operating plan recommendation. For example, a clinician may desire to adjust the origin point in the initial operating plan if there is a patient condition which invalidates the initial placement, such as calcification which can affect anastomosis success. As such, the clinician may, via input device(s) 210, user interface(s) 218, and/or network interface 208, adjust the origin point in the initial operating plan.
[0071] For example, processing circuitry 204 may determine a recommended (e.g., optimal) aorta graft location and determine potential obstacles, based on imaging data 214. For example, processing circuitry 204 may execute computer vision algorithm 224 to determine potential obstacles and processing circuitry 204 may determine the recommended aorta graft location to include a recommended graft path that avoids such obstacles.
[0072] In some examples, processing circuitry 204 may, through 3D model(s) 232 and/or operating plan(s) 220, facilitate the clinician placing a representative clamp and aortic root cannula in a model of the anatomy of the patient. Clamps and aortic root cannulas may reduce the amount of usable aorta for the CABG procedure. By allowing the clinician to represent such devices in 3D model(s) 232, processing circuitry 204 may determine better anastomosis location recommendations and better flow restoration estimates. For example, computer vision algorithm 224 may be trained on data including imaging data with claims and/or aortic root cannulas attached from past procedures and flow data associated with past procedures. As such, the clinician may, via input device(s) 210, user interface(s) 218, and/or network interface 208, place a representative clamp and/or aortic root cannula in 3D model(s) 232.
[0073] Processing circuitry 204 may determine recommended paths for each bypass based on imaging data 214. For example, it may be desirable for a path to generally run parallel to native anatomy and processing circuitry 204 may recommend a path for each bypass that runs parallel or generally parallel to native anatomy that appears in imaging data 214. For example, once the source and initial curvature is established, processing circuitry 204 may generate the remaining path elements. For example, processing circuitry 204 may generate a 3D model of the heart (e.g., of 3D model(s) 232) based on obtained imaging data, such as CCTA scans. In some examples, one or more of 3D model(s) 232 is part of one or more operating plan(s) 220. Based on the path and the curvature, which may be represented in the 3D model, processing circuitry 204 may determine a length of harvest vessel to be harvested. In some examples, processing circuitry 204 may include some additional length, such as 1-2 mm, for the clinician to work with.
[0074] Processing circuitry 204 may identify the restricted flows and extent of each blockage, based on the obtained imaging data 214 and/or manually input data. For example, if processing circuitry 204 recommends a merge with the occluded vessel 8mm past the blockage (which may be editable by the clinician), processing circuitry 204 may generate a contour generally following the native vessel when possible and the outer contour of the heart merging tangent to the first path section (e.g., to avoid a pulmonary trunk). Once processing circuitry 204 generates the full path, processing circuitry 204 may translate the path’s length into individual graft required lengths and an overall length of harvest which may be required to perform all of the grafts of the CABG procedure. [0075] In addition to the path requirements, vessel diameter may play a role in graft success. As such, processing circuitry 204 may, based on imaging data 214, such as CCTA scan data of the obstructed vessel(s) and/or harvest site information, rank the possible graft vessels and/or segments based on how similar each diameter (e.g., inner diameter) of a possible harvest vessel and/or segment is to a diameter (e.g., inner diameter) of the obstructed anatomy. For example, if a native vessel distal to a blockage has an inner diameter of 2.5mm which closely matches this patient’s radial artery inner diameter of 2.2mm, the patient’s radial artery may be an appropriate vessel for a graft (e.g., a good match) with straightforward anastomosis.
[0076] Processing circuitry 204 recommend and/or may facilitate a clinician inputting, e.g., via input device(s) 210, user interface(s) 218, and/or network interface 208, other information for inclusion into the finalized operating plan of operating plan(s) 220. For example, a clinician may enter a contour of anastomosis cut (e.g., angled or straight) which would affect a length of graft and blood flow characteristics. A clinician may enter a desire for excess slack for the graft to allow for a retry of an anastomosis if the initial anastomosis fails. In such case, processing circuitry 204 may add additional length to suggested or proposed donor vessel(s) and/or segment(s) to be harvested. A clinician may enter a desire to use a graft vessel from a single source for all bypasses of a given CABG procedure to preserve harvest sites, which may speed up the harvesting procedure and potentially reduce the number of harvest procedures performed. For example, processing circuitry 204 may recommend taking the vessel segments for the grafts from a particular location, e.g., SVG, if three grafts are to be performed and only the SVG can provide graft vessel segments for all three grafts.
[0077] In some examples, such as where a clinician may harvest a vessel prior to processing circuitry 204 determining a recommended graft location, processing circuitry 204 may determine a recommended graft location based at least in part on the diameter (e.g., inner diameter) of the harvested vessel. For example, a clinician may harvest segment(s) of a vessel and may desire to use such segment(s) as graft(s). Because the inner diameter of a segment to be used as a graft may not necessarily match the inner diameter of the occluded vessel at a given location, processing circuitry may determine where to locate the graft based, at least in part, on the inner diameter of the harvest segment. Such a location may be different than if the segment has an inner diameter that matches the inner diameter of the occluded vessel.
[0078] In some examples, an IMA (also called internal thoracic artery (ITA)) may be used as a graft vessel. An IMA typically runs along the inside of the chest wall and supplies blood to the anterior chest. Often this vessel is dissected and repositioned to supply blood distal to a blockage. Processing circuitry 204 may determine a recommendation, when using an IMA for a graft vessel, that may minimize or reduce dissection of the IMA from the chest wall to mitigate blood supply loss to an anterior chest wall (which may be associated with sternal wound infection). In some examples, processing circuitry 204 may recommend harvest such as excise the IMA from chest wall up to a specified rib, rather than all the way up to the collar bone.
[0079] Processing circuitry 204 may examine the potential harvest sites and provide recommendations and/or ranking of potential harvest vessel segments, based on bypass needs, as determined by processing circuitry 204 and/or entered by a clinician. For example, processing circuitry 204 may utilize bypass path determinations, such as (individual segment diameter, length, and/or total procedural needs) and inputs from preliminary harvest site scans (e.g., imaging data 214) to provide guidance during harvest. [0080] For example, a minimal total harvest length required for all the grafts to be performed during the CABG procedure may be utilized to determine a harvest location. For example, the SVG is normally substantially longer than the radial artery allowing for more and/or longer bypass requirements. If the radial artery has an insufficient length to cover all bypasses, the clinician may harvest from the SVG rather than harvest from multiple sites. Alternatively, or additionally, an inner diameter of a potential harvest vessel may be utilized to determine a harvest vessel. For example, it may be desirable for a graft inner diameter to match or relatively match an inner diameter of the occluded vessel.
[0081] If imaging data for the harvest site is unavailable for some reason, processing circuitry 204 may provide the clinician with an option to utilize a typical anatomy representation for the patient. In some examples, the typical anatomy may be based on a typical person. In some examples, the typical anatomy may include length and/or diameter for harvest site vessel(s) which may equate to a length and/or diameter of harvest site vessel(s) for an average person.
[0082] If imaging data 214 is available, the clinician may use the operating plan of operating plan(s) 220 to plan out multiple vessel sections within a single harvest operation. For example, sections with limited branch interruption may be preferred and may match up with the required lengths for bypass. By providing an indication of such harvest vessel recommendations, processing circuitry 204 may facilitate the limitation of the removal of donor vessel tissue to only what is required for the grafts, thus reducing the blood supply loss at the harvest site.
[0083] Processing circuitry 204 may providing an estimation of restored blood flow that is predicted to occur after a CABG procedure following the operating plan and include such an estimation in the operating plan. Processing circuitry 204 may, based on the planned grafts, utilize a flow diagnosis model to estimate restored flow to regions after the CABG procedure. In some examples, processing circuitry 204 may display such planned grafts together with determined restored flow estimates as part of the operating plan. Such information may be useful to a clinician and may impact a clinician’s decision about whether or not to change the operating plan.
[0084] For example, a display (such as display 206) may display a representation (e.g., via a color) of an estimated FFR based on the planned grafts in the graft vessel and other affected vessels as set forth in the operating plan. For example, the bypassed vessel may be shown in red, indicating a poor FFR, while the planned graft vessel(s) may be displayed in white, green, or another color, indicating a good or acceptable FFR and restored blood flow. In this manner, a clinician may review the operating plan and determine that the operating plan provides for an appropriate outcome prior to proceeding with the CABG procedure. If the clinician reviews the operating plan and determines that the operating plan does not provide for an appropriate outcome, the clinician may modify the operating plan prior to proceeding with the CABG procedure. In such a case, processing circuitry 204 may update the operating plan and control a display to display an updated estimated FFR based on the modified operating plan.
[0085] In some examples, processing circuitry 204 may consider competing blood flows in determining the restored flow estimates. For example, processing circuitry 204 may consider residual flow through the occluded vessel, flow through the proposed graft, and any reduced flow to the original ostia. If any of these may present concerns (e.g., negatively affect a blood flow analysis), processing circuitry 204 may provide a warning to the clinician and/or recommend adjustments to the operating plan. For example, a graft may shrink because of blood flow issues, which may not be beneficial to the patient. [0086] In some examples, processing circuitry 204 may determine estimates of backflow from the graft into the native vessel. If appropriate, processing circuitry 204 may, based on such determined estimates of backflow, warn against poor hemodynamics and the potential for backflow to dislodge calcium deposits leading to new obstructions distally. For example, if the determined estimates of backflow meet a backflow threshold, processing circuitry 204 may provide a such a warning to the clinician via a display (such as display 206) or any of output device(s) 212. Such a warning may be visual, auditory, haptic, or the like.
[0087] In some examples, the techniques of this disclosure may be utilized with a patient who is at intermediate or low risk of clinical events. For example, a patient may present with initial symptoms and undergo one or more screenings which may include CCTA or other imaging to collect imaging data 214. In some examples, a clinician may elect to use traditional “rule-of-thumb” techniques for patients that are most severe rather than use the patient-specific technique so this disclosure.
[0088] Less severe patients with “elective” surgery may receive additional testing and/or scans to provide imaging data 214. Processing circuitry 204 may determine recommended graft locations or combination of graft locations based on input data, such as imaging data 214. Additionally, or alternatively, processing circuitry 204 may determine recommended harvest segments based on input data, such as imaging data 214. Processing circuitry 204 may control a display (e.g., display 206) to display or otherwise provide recommendations (an initial operating plan of operating plan(s) 220) to a clinician. Processing circuitry 204 may provide a clinician with an opportunity to refine the initial operating plan. For example, the clinician may change a location for new ostium on the aorta for graft number 2. Processing circuitry 204 may redetermine the recommendations and output for display a revised operating plan of operating plan(s) 220) based on the clinician input, which processing circuitry 204 may iterate with the clinician. Processing circuitry 204 may generate a finalized operating plan for use by the clinician in preparing for and/or during the CABG procedure.
[0089] Processing circuitry 204 may be implemented by one or more processors, which may include any number of fixed-function circuits, programmable circuits, or a combination thereof. In various examples, control of any function by processing circuitry 204 may be implemented directly or in conjunction with any suitable electronic circuitry appropriate for the specified function. Fixed-function circuits refer to circuits that provide particular functionality and are preset on the operations that may be performed. Programmable circuits refer to circuits that may programmed to perform various tasks and provide flexible functionality in the operations that may be performed. For instance, programmable circuits may execute software or firmware that cause the programmable circuits to operate in the manner defined by instructions of the software or firmware. Fixed-function circuits may execute software instructions (e.g., to receive parameters or output parameters), but the types of operations that the fixed-function circuits perform are generally immutable. In some examples, the one or more of the units may be distinct circuit blocks (fixed-function or programmable), and in some examples, the one or more units may be integrated circuits.
[0090] Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), graphics processing units (GPUs) or other equivalent integrated or discrete logic circuitry. Accordingly, the term processing circuitry 204 as used herein may refer to one or more processors having any of the foregoing processor or processing structure or any other structure suitable for implementation of the techniques described herein. In addition, in some aspects, the functionality described herein may be provided within dedicated hardware or software modules configured for encoding and decoding, or incorporated in a combined codec. Also, the techniques could be fully implemented in one or more circuits or logic elements. [0091] Display 206 may be touch sensitive or voice activated, enabling display 206 to serve as both an input and output device. Alternatively, a keyboard (not shown), mouse (not shown), joystick (not shown) or other data input device(s)s (e.g., input device(s) 210) may be employed. In some examples, display 206 may include a virtual reality and/or augmented reality headset. In some examples, display 206 may include a hologram device.
[0092] Network interface 208 may be adapted to connect to a network (e.g., network 156) such as a local area network (LAN) that includes a wired network or a wireless network, a wide area network (WAN), a wireless mobile network, a Bluetooth network, or the internet. In some examples, network interface 208 may include one or more application programming interfaces (APIs) for facilitating communication with other devices. For example, computing device 200 may receive imaging data 214 from imager 140 and/or additional imager(s) 142 during a medical procedure via network interface 208. Computing device 200 may interact with server 160 via network interface 208. Computing device 200 may receive updates to its software, for example, applications 216, via network interface 208. Computing device 200 may also display notifications on display 206 that a software update is available.
[0093] Input device(s) 210 may include any device that enables a user to interact with computing device 200, such as, for example, a mousejoystick, keyboard, foot pedal, touch screen, augmented-reality input device(s) receiving inputs such as hand gestures or body movements, or voice interface.
[0094] Output device(s) 212 may include any connectivity port or bus, such as, for example, parallel ports, serial ports, universal serial busses (USB), or any other similar connectivity port known to those skilled in the art.
[0095] Applications 216 may include one or more software programs stored in memory 202 and executed by processing circuitry 204 of computing device 200. [0096] FIG. 3 is a conceptual diagram illustrating an example operating plan according to one or more aspects of this disclosure. Operating plan 300 may be an example of any of operating plan(s) 220, such as an original operating plan, an iteration of an operating plan, or a final operating plan.
[0097] Operating plan 300 may include recommended graft location(s) 302. Recommended graft location(s) 302 may include, for each recommended graft, one or more of a recommended graft origin, a recommended graft path, and a recommended graft termination. For example, recommended graft location(s) 302 may include, for a given recommended graft location a recommended graft origin (which may be one of distal to or proximal to a blockage) and a recommended graft termination (which may be the other of distal to or proximal to a blockage) and a recommended graft path therebetween.
[0098] Operating plan 300 may include a recommended vessel edge condition 330. For example, recommended vessel edge condition 330 may include a recommended cut angle (angle of cutting of the vessel to be used for a graft), a recommended taper (or lack thereof), or other condition of an edge or end of a vessel to be used for a graft. For example, processing circuitry 204 may perform a flow analysis and determine that a particular cut angle of a vessel to be used for a graft may provide an acceptable or preferred rate of flow after the CABG procedure and recommend that cut angle (e.g., 45 degrees) in recommended vessel edge condition 330. [0099] Operating plan 300 may include a harvest plan 304. Harvest plan 304 may include recommended segment(s) to harvest from a harvest vessel to use for the grafts. Processing circuitry 204 may determine such recommended segment(s) based on the length of segment (e.g., segment length 322) needed to traverse recommended graft path 310 and attach at recommended graft origin 306 and recommended graft termination 308, and/or the determined diameter (e.g., inner diameter) of the occluded vessel 332 and the determined diameter (e.g., inner diameter) of the harvest vessel segment (segment diameter 324). For example, harvest plan 304 may include a length of segment(s) required for the CABG procedure, a suggested (e.g., optimal) segment of the harvest vessel for each bypass, corresponding bypass pathways, an indication of the need for SVG support, if applicable, and/or the like.
[0100] In some examples, operating plan 300 may include one or more of 3D model(s) 232 described above with respect to FIG. 2. In some examples, operating plan 300 may include imaging data 214. In some examples, operating plan 300 may include SVG support 312, such as an estimated need for (or lack of a need for) SVG support and/or a recommendation for one or more SVG support devices to be used during the CABG procedure. In some examples, operating plan 300 may include one or more recommendations for dissecting an IMA graft from a chest wall (reach IMA 314), such as a recommended rib at which to cease detaching the IMA from the chest wall.
[0101] In some examples, operating plan 300 may include an estimate of flow restoration 316 to be accomplished by the CABG procedure. For example, estimate of flow restoration 316 may include an estimated fractional flow reserve (FFR) value associated with a graft to be accomplished during the CABG procedure. In some examples, operating plan 300 may include an indication of a recommendation of robotic assistance 318 for the CABG procedure, such as a recommendation for a robotic assisted surgical approach. In some examples, recommendation of robotic assistance 318 may include a recommended robotic positioning, at least one recommended access location on the patient, and/or at least one target output for robotic anastomosis. In some examples, operating plan 300 may include a recommendation for a surgical access strategy 320, such as how to access an area of the patient for attachment of a graft while minimizing incision size.
[0102] FIG. 4 is a conceptual diagram illustrating example operating plan techniques according to one or more aspects of this disclosure. While described as being performed by computing device 200 of FIG. 2, the techniques of FIG. 4 may be performed by any device or combination of devices of medical system 100 of FIG. 1 or any device(s) capable of performing these techniques.
[0103] Processing circuitry 204 obtain input data, the input data including imaging data of vasculature of a patient (400). For example, processing circuitry 204 may obtain input data, including imaging data 214 of vasculature of a patient from imager 140 and/or additional imager(s) 142. Processing circuitry 204 may determine, based on the input data, an operating plan, the operating plan including at least one recommended graft location, the recommended graft location including a recommended graft origin, a recommended graft path, and a recommended graft termination (402). For example, processing circuitry 204 may determine operating plan 300 that is patient-specific for the patient. Operating plan 300 may include at least one recommended graft location (e.g., recommended graft location(s) 302). The recommended graft location may include at least one of a recommended graft origin 306 (e.g., the location of the first attachment of a graft), a recommended graft path 310 (e.g., the route a grafted vessel may take from the graft origin to the graft termination), and a recommended graft termination 308 (e.g., the location of the second attachment of the graft). Processing circuitry 204 may output, for display, the operating plan (404). For example, processing circuitry 204 may output operating plan 300 to display 206 and/or display device 110.
[0104] In some examples, the at least one recommended graft location includes a recommended graft location for proximal anastomosis to an aorta. In some examples, the at least one recommended graft location includes a recommended graft location for distal anastomosis distal to a coronary obstruction. In some examples, the recommended graft path includes a path between the recommended graft origin and the recommended graft termination, the recommended graft path being configured to avoid any obstacles between the recommended graft origin and the recommended graft termination.
[0105] In some examples, operating plan 300 further includes at least one recommended vessel edge condition of a vessel to be used for a graft. In some examples, the at least one recommended vessel edge condition comprises at least one cut angle. [0106] In some examples, processing circuitry 204 is further configured to determine one or more recommended harvest vessel segment lengths based, at least in part, on the at least one recommended graft location. In some examples, operating plan 300 further includes the one or more recommended harvest vessel segment lengths. In some examples, processing circuitry 204 is further configured to determine at least one recommended harvest vessel segment, the at least one recommended harvest vessel segment being based, at least in part, on the one or more recommended harvest vessel segment lengths, and a recommended harvest vessel anatomy. In some examples, operating plan 300 further includes a harvest plan, the harvest plan including an identification of the at least one recommended harvest vessel segment. In some examples, the recommended harvest vessel anatomy includes a recommended harvest vessel diameter, the recommended harvest vessel diameter being based on a diameter of an obstructed vessel.
[0107] In some examples, processing circuitry 204 is further configured to obtain user input associated with operating plan 300. In some examples, the user input may be obtained during the CABG procedure. In some examples, the user input may be obtained prior to the CABG procedure. In some examples, processing circuitry 204 may amend operating plan 300 based on the user input to generate an amended operating plan or iteration of the operating plan (e.g., of operating plan(s) 220). In some examples, processing circuitry 204 is configured to output, for display, the amended operating plan. [0108] In some examples, imaging data 214 includes CCTA imaging data. In some examples, imaging data 214 includes angiogram imaging data. In some examples, imaging data 214 includes FFR angiogram imaging data. In some examples, imaging data 214 includes at least one of imaging data of at least one blocked vessel or imaging data of at least one potential harvest vessel. In some examples, the input data further includes at least one of information relating to at least one potential harvest vessel, a measure or an estimate of coronary perfusion pressure (CPP), or an indication of whether the CABG procedure is a robotic assisted procedure. For example, a clinician may input such information via user interface(s) 218, input device(s) 210 or network interface 208, and/or processing circuitry 204 may obtain such information from additional equipment 152.
[0109] In some examples, processing circuitry 204 is further configured to determine at least one of an estimate for SVG support, one or more recommendations for dissecting an IMA graft from a chest wall, or one or more recommendations of a robotic assisted surgical approach. In such examples, operating plan 300 may further include at least one of the estimate for SVG support, the one or more recommendations for dissecting an IMA graft from a chest wall, or the one or more recommendations of a robotic assisted surgical approach.
[0110] In some examples, processing circuitry 204 is further configured to determine an estimate of flow restoration based on at least one of the recommendations. In such examples, operating plan 300 may further include a representation of the estimate of flow restoration.
[OHl] In some examples, processing circuitry 204 is further configured to determine at least one of recommended robotic positioning, at least one recommended access location on the patient, or at least one target output for robotic anastomosis. In such examples, operating plan 300 may include at least one of the recommended robotic positioning, the at least one recommended access location on the patient, or the at least one target output for robotic anastomosis.
[0112] Operating plan 300 may provide a clinician with advanced knowledge of case specifics (e.g., graft length required, robotic articulation limitations, vessel condition, etc.). A CABG procedure being performed by a clinician utilizing operating plan 300 may result in improved blood flow due minimizing graft length and matching vessel diameters and reduced blood supply loss to harvest site when compared to not using such an operating plan. The use of operating plan 300 may result in CABG procedure time savings, for selecting, cutting and/or positioning grafts.
[0113] FIG. 5 is a conceptual diagram illustrating example potential harvest vessels according to one or more aspects of this disclosure. Any of IMA 500, radial arteries 502, or greater saphenous veins 506, or other harvest sites (not shown) may be potential harvest vessels for use in a CABG procedure. For example, processing circuitry 204 may, based on imaging data 214, determine one or more recommended graft location(s) 302. A recommended graft location may include at least one of a recommended graft origin 306, a recommended graft path 310, or a recommended graft termination 308. For a given graft location, processing circuitry 204 may determine an appropriate length of a harvest vessel segment for the recommended graft based on the graft location. Also, processing circuitry 204 may determine an appropriate diameter (e.g., inner diameter) of a harvest vessel segment to be used for the graft based on the diameter (e.g., inner diameter) of the occluded vessel the graft is meant to bypass. Processing circuitry 204 may use the information of determined length and diameter to attempt to find an appropriate segment of a harvest vessel to be used for the graft. For example, processing circuitry 204 may use imaging data 214 of potential harvest vessels to identify a vessel segment of a potential harvest vessel having an appropriate length and diameter for use as in the graft.
Processing circuitry 204 may attempt to identify bifurcations or other structural features in the potential harvest vessels which may make some segments less desirable to use so as to avoid the use, when possible, of such segments. [0114] It should be noted that the techniques of this disclosure may be utilized even when a harvest procedure is not part of the CABG procedure. For example, a clinician may use one or more artificial, cadaveric, or animal vessels for the CABG procedure, rather than, or in addition to, one or more harvest vessels from the patient.
[0115] FIG. 6 is a conceptual diagram illustrating different example surgical access techniques. When determining operating plan 300, processing circuitry 204 may recommend a surgical access strategy, for example, based on graft location(s) 302. Surgical access strategy 600 may include a median sternotomy and may provide the greatest access and/or visibility into the region of the patient where the graft will be located. However, surgical access strategy 600 may involve cutting completely through the sternum vertically to open up the entire chest cavity. Surgical access strategy 600 may therefore be considered a relatively highly invasive procedure and generally requires a longer recovery period for the patient than the other potential surgical access strategies. If less access is likely to be needed to perform the CABG procedure, processing circuitry 204 may recommend a different surgical access strategy, such as any of surgical access strategies 602, 604, or 606. Surgical access strategy 602 may involve cutting partially through the sternum vertically and then making one or more lateral cuts across the sternum to open up a portion of the chest cavity (e.g., an upper portion of the chest cavity). Surgical access strategy 604 may involve cutting partially through the sternum vertically and then making a single lateral cut to one side of the sternum to open up a portion of the chest cavity (e.g., an upper-left portion of the chest cavity). Surgical access strategy 606 may completely avoid cutting the sternum, instead making an incision through tissue between the ribs to open up access only through the incision itself. The examples of FIG. 6 are presented, generally, in order of greatest invasiveness/access/visibility with surgical access strategy 600 having the greatest invasiveness/access/visibility, followed by surgical access strategy 602, followed by surgical access strategy 604, and followed by surgical access strategy 606, having the least invasiveness/access/visibility. As patient recovery times and comfort may be affected by which access strategy is ultimately used by a clinician, processing circuitry 204 may recommend the least invasive surgery access strategy which may provide adequate access to perform the recommended graft as part of operating plan 300.
[0116] FIG. 7 is a conceptual diagram of an example 3D model of a heart according to one or more aspects of this disclosure. 3D model 700 may be an example of one of 3D model(s) 232 of FIGS. 2-3. Processing circuitry 204 may present 3D model 700 via user interface(s) 218 for example, on display 206, either as part of operating plan 300 or separately. A clinician may interact with user interface(s) 218 to, for example, place clamp representation 702 and/or aortic root cannula representation 704 in preferred location(s) on a representation of the heart of the patient. As, clamps and aortic root cannulas may reduce the amount of usable aorta for the CABG procedure, processing circuitry 204 may use the preferred location(s) as inputs to iterate on recommended graft location(s) and any associated harvest plans. For example, processing circuitry 204 may generate an updated plan including updated recommendation(s).
[0117] FIG. 8 is a conceptual diagram illustrating an example recommended graft location in accordance with one or more aspects of this disclosure. The recommended graft location of FIG. 8, which may be an example of a recommended graft location of recommended graft location(s) 302, may include a recommended graft origin 800, a recommended graft termination 802, and a recommended graft path 804. Recommended graft path 804 may avoid the pulmonary trunk and follow the contour of the heart surface while avoiding obstacles and connect the recommended graft origin 800 to recommended graft termination 802 to bypass the blockage.
[0118] FIG. 9 is a conceptual diagram illustrating an example harvested radial artery. Harvested radial artery 900 may be an example of a segment of a radial artery harvested without the use of harvest plan 304. For example, harvested radial artery 900 may be harvested for use in two grafts. Once harvested, a clinician may cut harvested radial artery 900 for use in the two grafts. Segment 902 may be designated for use in a first graft and segment 904 may be designated for use in a second graft. However, segment 902 may include a clipped branch 908 (e.g., formerly a bifurcation) which may be undesirable in a graft. Additionally, the length of harvested radial artery 900 may be greater than necessary as harvested radial artery 900 has an arbitrary end point 906 where the clinician cut the radial artery during harvesting. As such, harvested radial artery 900 includes a wasted segment 910, which would have been better left in place in the arm of the patient. If harvest plan 304 had been used, the harvest plan may have set forth a better planned end point than arbitrary end point 906 and avoided recommending segment 902 for use in a graft due to clipped branch 908 or a bifurcation.
[0119] FIG. 10 is a conceptual diagram illustrating an example use of a 3D model generated based on imaging data other than CCTA imaging data in accordance with one or more aspects of this disclosure. As discussed above, the techniques of this disclosure may be used with imaging data such as CCTA imaging data and/or other imaging data. For example, not all patients will go from the emergency room to receive a CCTA, but the techniques of this disclosure may still be used with such a patient via other imaging modalities. For example, a patient may go to a Cath lab for a coronary angiography and/or percutaneous coronary intervention (PCI) due to the patient experiencing chest pain, fatigue, and/or the like. Once in the Cath lab, a clinician may discover that the patient is suffering from multivessel lesions. In such a case, the patient may then be referred to undergo a CABG procedure.
[0120] As technology like FFR angiography becomes more widely used, this technology may become a relatively quick and reliable way to diagnose multiple lesions and assess lesion severity. For example, additional imager(s) 142 may include one or more imagers such as a FFR angiography imager. Additional imager(s) 142 may capture and/or perform an analysis of a whole coronary tree, including the RCA and LCA, at once by taking multiple angio images. Such a procedure may be easier and quicker than running a pressure wire through every potential lesion, like traditional FFR and/or instantaneous wave-free ratio (IFR).
[0121] System 100 may utilize imaging data 214 from other imager(s) 142, such as an FFR angiography imager, to generate a 3D model used to calculate FFR from angiography images. In some examples, system 100 may store such a 3D model in 3D model(s) 232. In some examples, system 100 may use the imaging data and/or the 3D model used to calculate FFR to generate one or more of 3D model(s) 232 and/or operating plan(s) 220, including a recommended graft origin, a recommended graft path, and a recommended graft termination. For example, system 100 may display user interface 1000, e.g., on display device 110, which may include a representation of the 3D model used to calculate FFR. User interface 1000 may be an example of a user interface of user interface(s) 218 (FIG. 2). User interface 1000 may include a user selectable button or icon 1002 which a clinician may select to invoke additional processing by system 100 to adapt (e.g., optimize) the 3D model for use by system 100 to generate operating plan(s) 220 for graft placement.
[0122] FIG. 11 is a conceptual diagram illustrating contents of another example operating plan in accordance with one or more aspects of this disclosure. This additional processing step, which may only take minutes, may, for example, be initiated by a clinician at any point, such as during a transfer from diagnostic to surgery, during a follow up exam, or the like. In some examples, the additional processing step may be initiated by a structural heart surgeon, rather than an interventional cardiologist, as the patient is being transferred from diagnostic to surgery and/or being prepared for surgery using the already captured images (e.g., imaging data 214) instead of obtaining more images, such as CCTA images from imager 140.
[0123] In some examples, this process can also be performed during a follow up appointment if the case is not severe enough to warrant a CABG the day the lesions are discovered, as imaging data 214 may already be stored within system 100. In such a case, additional images, such as CCTA images, may be captured from imager 140 and/or additional imager(s) 142 by system 100 if desired for additional data which may be used to generate or alter any of 3D model(s) 232 and/or operating plan(s) 220.
[0124] In some examples, harvest site information may not be available, for example, if only obtained coronary angiography imaging data is used. However, generated operating plan(s) 220 may still incorporate recommendations, such as length and diameter(s) of harvest vessels to help aid a clinician in determining harvest sites, such as recommendation 1100 for a harvest vessel for use as a bypass vessel 1102. Additional information, such as a placement location into the diseased artery, as well as aortic placement may be included in operating plan(s) 220. For example, operating plan(s) 220 may include a recommended graft origin, a recommended graft path, and a recommended graft termination regardless of whether imaging data 214 includes CCTA imaging data, FFR angiography imaging data, or other imaging data.
[0125] The techniques discussed herein may be used in any combination or alone.
[0126] The techniques described in this disclosure may be implemented, at least in part, in hardware, software, firmware or any combination thereof. For example, various aspects of the described techniques may be implemented within one or more processors or processing circuitry, including one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), or any other equivalent integrated or discrete logic circuitry, as well as any combinations of such components. The terms “controller”, “processor”, or “processing circuitry” may generally refer to any of the foregoing logic circuitry, alone or in combination with other logic circuitry, or any other equivalent circuitry. A control unit comprising hardware may also perform one or more of the techniques of this disclosure. Such hardware, software, and firmware may be implemented within the same device or within separate devices to support the various operations and functions described in this disclosure. In addition, any of the described units, circuits or components may be implemented together or separately as discrete but interoperable logic devices. Depiction of different features as circuits or units is intended to highlight different functional aspects and does not necessarily imply that such circuits or units must be realized by separate hardware or software components. Rather, functionality associated with one or more circuits or units may be performed by separate hardware or software components or integrated within common or separate hardware or software components.
[0127] The techniques described in this disclosure may also be embodied or encoded in a computer-readable medium, such as a computer-readable storage medium, containing instructions. Instructions embedded or encoded in a computer-readable storage medium may cause a programmable processor, or other processor, to perform the method, e.g., when the instructions are executed. Computer readable storage media may include random access memory (RAM), read only memory (ROM), programmable read only memory (PROM), erasable programmable read only memory (EPROM), or electronically erasable programmable read only memory (EEPROM), or other computer readable media.
[0128] This disclosure includes the following non-limiting examples.
[0129] Example 1. A medical system comprising: memory configured to store an operating plan for a coronary artery bypass graft (CABG) procedure; and processing circuitry communicatively coupled to the memory, the processing circuitry being configured to: obtain input data, the input data comprising imaging data of vasculature of a patient; determine, based on the input data, the operating plan, the operating plan comprising at least one recommended graft location, the recommended graft location including a recommended graft origin, a recommended graft path, and a recommended graft termination; and output, for display, the operating plan.
[0130] Example 2. The medical system of example 1, wherein the at least one recommended graft location comprises a recommended graft location for proximal anastomosis to an aorta.
[0131] Example 3. The medical system of example 1 or 2, wherein the at least one recommended graft location comprises a recommended graft location for distal anastomosis distal to a coronary obstruction.
[0132] Example 4. The medical system of any of examples 1-3, wherein the recommended graft path comprises a path between the recommended graft origin and the recommended graft termination, the recommended graft path being configured to avoid any obstacles between the recommended graft origin and the recommended graft termination. [0133] Example 5. The medical system of any of examples 1-4, wherein the operating plan further comprises at least one recommended vessel edge condition of a vessel to be used for a graft.
[0134] Example 6. The medical system of example 5, wherein the at least one recommended vessel edge condition comprises at least one cut angle.
[0135] Example 7. The medical system of any of examples 1-6, wherein the processing circuitry is further configured to determine one or more recommended harvest vessel segment lengths based, at least in part, on the at least one recommended graft location, and wherein the operating plan further comprises the one or more recommended harvest vessel segment lengths.
[0136] Example 8. The medical system of example 7, wherein the processing circuitry is further configured to determine at least one recommended harvest vessel segment, the at least one recommended harvest vessel segment being based, at least in part, on the one or more recommended harvest vessel segment lengths, and a recommended harvest vessel anatomy, and wherein the operating plan further comprises a harvest plan, the harvest plan comprising an identification of the at least one recommended harvest vessel segment.
[0137] Example 9. The medical system of example 8, wherein the recommended harvest vessel anatomy comprises a recommended harvest vessel diameter, the recommended harvest vessel diameter being based on a diameter of an obstructed vessel.
[0138] Example 10. The medical system of any of examples 1-9, wherein the processing circuitry is further configured to: obtain user input associated with the operating plan; amend the operating plan based on the user input to generate an amended operating plan; and output, for display, the amended operating plan.
[0139] Example 11. The medical system of any of examples 1-10, wherein the imaging data comprises coronary computed tomography angiogram (CCTA) imaging data.
[0140] Example 12. The medical system of any of examples 1-11, wherein the imaging data comprises angiogram imaging data.
[0141] Example 13. The medical system of any of examples 1-12, wherein the imaging data comprises fractional flow reserve (FFR) angiogram imaging data. [0142] Example 14. The medical system of any of examples 1-13, wherein as part of determining the operating plan, the processing circuitry is configured to determine a three-dimensional model based on the input data.
[0143] Example 15. The medical system of any of examples 1-14, wherein the imaging data comprises at least one of imaging data of at least one blocked vessel or imaging data of at least one potential harvest vessel.
[0144] Example 16. The medical system of any of examples 1-15, wherein the input data further comprises at least one of information relating to at least one potential harvest vessel, a measure or an estimate of coronary perfusion pressure (CPP), or an indication of whether the CABG procedure is a robotic assisted procedure.
[0145] Example 17. The medical system of any of examples 1-16, wherein the processing circuitry is further configured to determine at least one of an estimate for saphenous vein graft (SVG) support, one or more recommendations for dissecting an internal mammary artery (IMA) graft from a chest wall, or one or more recommendations of a robotic assisted surgical approach, and wherein the operating plan further comprises at least one of the estimate for SVG support, the one or more recommendations for dissecting thelMA graft from a chest wall, or the one or more recommendations of the robotic assisted surgical approach.
[0146] Example 18. The medical system of any of examples 1-17, wherein the processing circuitry is further configured to determine an estimate of flow restoration based on at least one of the recommendations, and wherein at least one of the operating plan further comprises a representation of the estimate of flow restoration.
[0147] Example 19. The medical system of any of examples 1-18, wherein the processing circuitry is further configured to determine at least one of recommended robotic positioning, at least one recommended access location on the patient, or at least one target output for robotic anastomosis, and wherein the operating plan comprises at least one of the recommended robotic positioning, the at least one recommended access location on the patient, or the at least one target output for robotic anastomosis.
[0148] Example 20. A method comprising: obtaining, by processing circuitry, input data, the input data comprising imaging data of vasculature of a patient; determining, by the processing circuitry and based on the input data, an operating plan, the operating plan comprising at least one recommended graft location, the recommended graft location including a recommended graft origin, a recommended graft path, and a recommended graft termination; and outputting, by the processing circuitry and for display, the operating plan.
[0149] Example 21. The method of example 20, wherein the at least one recommended graft location comprises a recommended graft location for proximal anastomosis to an aorta.
[0150] Example 22. The method of example 20 or 21, wherein the at least one recommended graft location comprises a recommended graft location for distal anastomosis distal to a coronary obstruction.
[0151] Example 23. The method of any of examples 20-22, wherein the recommended graft path comprises a path between the recommended graft origin and the recommended graft termination, the recommended graft path being configured to avoid any obstacles between the recommended graft origin and the recommended graft termination.
[0152] Example 24. The method of any of examples 20-23, wherein the operating plan further comprises at least one recommended vessel edge condition of a vessel to be used for a graft.
[0153] Example 25. The method of example 24, wherein the at least one vessel edge condition comprises at least one cut angle.
[0154] Example 26. The method of any of examples 20-25, further comprising determining, by the processing circuitry, one or more recommended harvest vessel segment lengths based, at least in part, on the at least one recommended graft location, and wherein the operating plan further comprises the one or more recommended harvest vessel segment lengths.
[0155] Example 27. The method of example 26, further comprising determining, by the processing circuitry, at least one recommended harvest vessel segment, the at least one recommended harvest vessel segment being based, at least in part, on the one or more recommended harvest vessel segment lengths, and a recommended harvest vessel anatomy, and wherein the operating plan further comprises a harvest plan, the harvest plan comprising an identification of the at least one recommended harvest vessel segment.
[0156] Example 28. The method of example 27, wherein the recommended harvest vessel anatomy comprises a recommended harvest vessel diameter, the recommended harvest vessel diameter being based on a diameter of an obstructed vessel. [0157] Example 29. The method of any of examples 20-28, further comprising: obtaining, by the processing circuitry, user input associated with the operating plan; amending, by the processing circuitry, the operating plan based on the user input to generate an amended operating plan; and outputting, by the processing circuitry and for display, the amended operating plan.
[0158] Example 30. The method of any of examples 20-29, wherein the imaging data comprises coronary computed tomography angiogram (CCTA) imaging data.
[0159] Example 31. The method of any of examples 20-30, wherein the imaging data comprises angiogram imaging data.
[0160] Example 32. The method of any of examples 20-31, wherein the imaging data comprises fractional flow reserve (FFR) angiogram imaging data.
[0161] Example 33. The method of any of examples 20-32, wherein determining the operating plan comprises determining a three-dimensional model based on the input data.
[0162] Example 34. The method of any of examples 20-33, wherein the imaging data comprises at least one of imaging data of at least one blocked vessel or imaging data of at least one potential harvest vessel.
[0163] Example 35. The method of any of examples 20-34, wherein the input data further comprises at least one of information relating to at least one potential harvest vessel, a measure or an estimate of coronary perfusion pressure (CPP), or an indication of whether a CABG procedure is a robotic assisted procedure.
[0164] Example 36. The method of any of examples 20-35, further comprising determining, by the processing circuitry, at least one of an estimate for saphenous vein graft (SVG) support, one or more recommendations for dissecting an internal mammary artery (IMA) graft from a chest wall, or one or more recommendations of a robotic assisted surgical approach, and wherein the operating plan further comprises at least one of the estimate for SVG support, the one or more recommendations for dissecting the IMA graft from a chest wall, or the one or more recommendations of the robotic assisted surgical approach.
[0165] Example 37. The method of any of examples 20-36, further comprising determining, by the processing circuitry, an estimate of flow restoration based on at least one of the recommendations, and wherein at least one of the operating plan further comprises a representation of the estimate of flow restoration. [0166] Example 38. The method of any of examples 20-37, further comprising determining, by the processing circuitry, at least one of recommended robotic positioning, at least one recommended access location on the patient, or at least one target output for robotic anastomosis, and wherein the operating plan comprises at least one of the recommended robotic positioning, the at least one recommended access location on the patient, or the at least one target output for robotic anastomosis.
[0167] Example 39. A non-transitory computer-readable storage medium storing instructions, which, when executed, cause processing circuitry to: obtain input data, input data comprising imaging data of vasculature of a patient; determine, based on the input data, an operating plan, the operating plan comprising at least one recommended graft location, the recommended graft location including a recommended graft origin, a recommended graft path, and a recommended graft termination; and output, for display, the operating plan.
[0168] Various examples have been described. These and other examples are within the scope of the following claims.

Claims

WHAT IS CLAIMED IS:
1. A medical system comprising: memory configured to store an operating plan for a coronary artery bypass graft (CABG) procedure; and processing circuitry communicatively coupled to the memory, the processing circuitry being configured to: obtain input data, the input data comprising imaging data of vasculature of a patient; determine, based on the input data, the operating plan, the operating plan comprising at least one recommended graft location, the recommended graft location including a recommended graft origin, a recommended graft path, and a recommended graft termination; and output, for display, the operating plan.
2. The medical system of claim 1, wherein the at least one recommended graft location comprises a recommended graft location for proximal anastomosis to an aorta.
3. The medical system of claim 1 or 2, wherein the at least one recommended graft location comprises a recommended graft location for distal anastomosis distal to a coronary obstruction.
4. The medical system of any of claims 1-3, wherein the recommended graft path comprises a path between the recommended graft origin and the recommended graft termination, the recommended graft path being configured to avoid any obstacles between the recommended graft origin and the recommended graft termination.
5. The medical system of any of claims 1-4, wherein the operating plan further comprises at least one recommended vessel edge condition of a vessel to be used for a graft.
6. The medical system of claim 5, wherein the at least one recommended vessel edge condition comprises at least one cut angle.
7. The medical system of any of claims 1-6, wherein the processing circuitry is further configured to determine one or more recommended harvest vessel segment lengths based, at least in part, on the at least one recommended graft location, and wherein the operating plan further comprises the one or more recommended harvest vessel segment lengths.
8. The medical system of claim 7, wherein the processing circuitry is further configured to determine at least one recommended harvest vessel segment, the at least one recommended harvest vessel segment being based, at least in part, on the one or more recommended harvest vessel segment lengths, and a recommended harvest vessel anatomy, and wherein the operating plan further comprises a harvest plan, the harvest plan comprising an identification of at least one recommended harvest vessel segment.
9. The medical system of claim 8, wherein the recommended harvest vessel anatomy comprises a recommended harvest vessel diameter, the recommended harvest vessel diameter being based on a diameter of an obstructed vessel.
10. The medical system of any of claims 1-9, wherein the processing circuitry is further configured to: obtain user input associated with the operating plan; amend the operating plan based on the user input to generate an amended operating plan; and output, for display, the amended operating plan.
11. The medical system of any of claims 1-10, wherein the imaging data comprises at least one of coronary computed tomography angiogram (CCTA) imaging data, angiogram imaging date, or fractional flow reserve (FFR) angiogram imaging data.
12. The medical system of any of claims 1-11, wherein the imaging data comprises at least one of imaging data of at least one blocked vessel or imaging data of at least one potential harvest vessel.
13. The medical system of any of claims 1-12, wherein the input data further comprises at least one of information relating to at least one potential harvest vessel, a measure or an estimate of coronary perfusion pressure (CPP), or an indication of whether the CABG procedure is a robotic assisted procedure.
14. The medical system of any of claims 1-13, wherein the processing circuitry is further configured to determine at least one of an estimate for saphenous vein graft (SVG) support, one or more recommendations for dissecting an internal mammary artery (IMA) graft from a chest wall, or one or more recommendations of a robotic assisted surgical approach, and wherein the operating plan further comprises at least one of the estimate for SVG support, the one or more recommendations for dissecting the IMA graft from a chest wall, or the one or more recommendations of the robotic assisted surgical approach.
15. A method comprising: obtaining, by processing circuitry, input data, the input data comprising imaging data of vasculature of a patient; determining, by the processing circuitry and based on the input data, an operating plan, the operating plan comprising at least one recommended graft location, the recommended graft location including a recommended graft origin, a recommended graft path, and a recommended graft termination; and outputting, by the processing circuitry and for display, the operating plan.
EP23844030.9A 2023-02-24 2023-12-08 OPTIMIZATION OF A CORONARY ARTERY BYPASS IMPLANT Pending EP4669247A1 (en)

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US9042613B2 (en) * 2013-03-01 2015-05-26 Heartflow, Inc. Method and system for determining treatments by modifying patient-specific geometrical models
US10772684B2 (en) * 2014-02-11 2020-09-15 Koninklijke Philips N.V. Spatial visualization of internal mammary artery during minimally invasive bypass surgery
WO2016092420A1 (en) * 2014-12-08 2016-06-16 Koninklijke Philips N.V. Devices, systems, and methods for vessel assessment and intervention recommendation
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