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CA-3041538-C - SELECTING A MEDICAL DEVICE FOR USE IN A MEDICAL PROCEDURE

CA3041538CCA 3041538 CCA3041538 CCA 3041538CCA-3041538-C

Abstract

A method for selecting a medical device for use in the performance of a medical procedure. The method comprises acquiring image data relating to an anatomical region of interest of a patient's body and generating a multi-dimensional depiction of the anatomical region of interest using the acquired image data. The method further comprises defining a plurality of points relative to the multi-dimensional depiction, determining one or more measurements based on the defined plurality of points, and then selecting a medical device to be used based on the determined measurements.

Inventors

  • Dee Dee Wang
  • Michael Forbes
  • Eric Myers
  • William O'Neill

Assignees

  • HENRY FORD HEALTH SYSTEM

Dates

Publication Date
20260505
Application Date
20171108
Priority Date
20161108

Claims (16)

  1. CLAIMS 1. A method for selecting a medical device for use in the performance of a medical procedure involving a left atrial appendage ("LAA") of a heart of a patient, comprising: acquiring image data relating to an anatomical region of interest of a body of the patient; 5 generating a multi-dimensional depiction of the anatomical region of interest using the acquired image data; defining a plurality of points relative to the multi-dimensional depiction, wherein at least one of the plurality of points corresponds to a centroid of an anatomical structure of the body of the patient, and further wherein the plurality of points comprises two or more of the following individual points: a point within a true ostium plane that contains a true ostium of the LAA, wherein the point corresponds to the centroid of the true ostium of the LAA; a point within an offset true ostium plane that is a duplicate of and offset from the true ostium plane, wherein the point is offset from the point in the true ostium plane and corresponds to the centroid of the true ostium of the LAA; a point within a fossa ovalis plane that contains the fossa ovalis of the heart of the patient, wherein the point corresponds to the centroid of the fossa ovalis; or a point within an inferior vena cava ("IVC") plane that contains the IVC ostium of the heart of the patient, wherein the point corresponds to the centroid of the ostium of the IVC; obtaining one or more measurements in the multi-dimensional depiction, the one or more measurements being at least partially based on the defined plurality of points; and selecting a medical device to be used based on the obtained measurements, wherein the 25 medical device comprises a catheter to be used to deliver an LAA occlusion device to the LAA of the heart of the patient.
  2. 2. The method of claim 1, wherein the one or more measurements obtained in the 30 obtaining step comprise at least one or more of: a distance between the origin of the IVC ostium plane and the origin of the fossa ovalis plane; 27 Date Re9ue/Date Received 2024-02-16 a distance between the origin of the fossa ovalis plane and the origin of the true ostium plane; an angle defined by the origin of the IVC ostium plane, the origin of the fossa ovalis plane, and the origin of the true ostium plane; and 5 an angle defined by the origin of the fossa ovalis plane, the origin of the true ostium plane, and the origin of the offset true ostium plane.
  3. 3. The method of claim 2, wherein the measurements further include a distance between a first plane that is a duplicate of and offset from a plane containing a mitral annulus of the 10 heart of the patient and that is aligned with the origin of the true ostium plane, and a second plane that is a duplicate of and offset from the plane containing the mitral annulus and that is aligned with the origin of the fossa ovalis plane. 15
  4. 4. The method of claim 1, further comprising: identifying in the multi-dimensional depiction an insertion point along an interatrial septum; selecting a model representative of the medical device that will pass through the interatrial septum during the performance of the medical procedure; positioning the model of the medical device in the multi-dimensional depiction, wherein the model is positioned within the multi-dimensional depiction relative to the identified insertion point; and evaluating the appropriateness of the insertion point, the medical device, or both based on the trajectory of the model of the medical device within the depiction.
  5. 5. The method of claim 1, further comprising receiving at least one user input, and in response to that at least one user input, the method further comprising: identifying in the multi-dimensional depiction an insertion point along an interatrial septum; selecting a model representative of the medical device that will pass through the interatrial septum during the performance of the medical procedure; positioning the model of the medical device in the multi-dimensional depiction, wherein the model is positioned within the multi-dimensional depiction relative to the identified insertion point. 28 Date Re9ue/Date Received 2024-02-16
  6. 6. A non-transitory, computer-readable storage medium storing instructions thereon that when executed by one or more electronic processors causes the one or more processors to carry out a method of selecting a medical device for use in performance of a medical procedure involving a left atrial appendage ("LAA") of a heart of a patient, wherein the method 5 compnses: acquiring image data relating to an anatomical region of interest of a body of the patient; generating a multi-dimensional depiction of the anatomical region of interest using the acquired image data; defining a plurality of points relative to the multi-dimensional depiction, wherein at 10 least one of the plurality of points corresponds to a centroid of an anatomical structure of the body of the patient, and further wherein the plurality of points comprises two or more of the following individual points: a point within a true ostium plane that contains a true ostium of the LAA, wherein the point corresponds to the centroid of the true ostium of the LAA; a point within an offset true ostium plane that is a duplicate of and offset from the true ostium plane, wherein the point is offset from the point in the true ostium plane and corresponds to the centroid of the true ostium of the LAA; a point within a fossa ovalis plane that contains the fossa ovalis of the heart of the patient, wherein the point corresponds to the centroid of the fossa ovalis; or a point within an inferior vena cava ("IVC") plane that contains the IVC ostium of the heart of the patient, wherein the point corresponds to the centroid of the ostium of the IVC; determining one or more measurements based on the defined plurality of points; and selecting a medical device to be used based on the determined measurements, wherein the medical device comprises a catheter to be used to deliver an LAA occlusion device to the LAA of the heart of the patient. 30
  7. 7. The storage medium of claim 6, wherein the one or more measurements comprise at least one or more of: a distance between the origin of the IVC ostium plane and the origin of the fossa ovalis plane; 29 Date Re9ue/Date Received 2024-02-16 a distance between the origin of the fossa ovalis plane and the origin of the true ostium plane; an angle defined by the origin of the IVC ostium plane, the origin of the fossa ovalis plane, and the origin of the true ostium plane; and 5 an angle defined by the origin of the fossa ovalis plane, the origin of the true ostium plane, and the origin of the offset true ostium plane.
  8. 8. The storage medium of claim 6, wherein the plurality of points comprises at least two or more of the following individual points: 10 an origin of a plane that contains a mitral annulus of the heart of the patient ("mitral plane"); an origin of a plane that is a duplicate of and offset from the mitral plane ("offset mitral plane"); and an intersection point of the offset mitral plane and a plane that is offset from the fossa 15 ovalis plane ("offset fossa ovalis plane").
  9. 9. The storage medium of claim 8, wherein the one or more measurements comprise at least one or more of: a distance between the origin of the mitral plane and the origin of the offset mitral plane; 20 a distance between the origin of the mitral plane and the intersection point of the offset mitral plane and offset fossa ovalis plane; a distance between the offset mitral plane and the intersection point of the offset mitral plane and offset fossa ovalis plane; an angle formed by the origin of offset mitral plane, the origin of the mitral plane, and 25 the intersection point of the offset mitral plane and off set fossa ovalis plane; an angle formed by the origin of the mitral plane, the origin of the offset mitral plane, and the intersection point of the offset mitral plane and offset fossa ovalis plane; an angle formed by the origin of the mitral plane, the intersection point of the offset mitral plane and offset fossa ovalis plane, and the origin of the offset mitral plane; 30 an angle formed by the origin of the IVC ostium plane, the original of the fossa ovalis plane, and the origin of the mitral plane; and an angle formed by the origin of the fossa ovalis plane, the origin of the mitral plane, and the origin of the off set mitral plane. Date Re9ue/Date Received 2024-02-16
  10. 10. The method of claim 6, wherein the method carried out by the one or more processors further comprises: identifying in the multi-dimensional depiction an insertion point along an interatrial septum; selecting a model representative of the medical device that will pass through the interatrial septum during the performance of the medical procedure; positioning the model of the medical device in the multi-dimensional depiction, wherein the model is positioned within the multi-dimensional depiction relative to the identified insertion point; and evaluating appropriateness of the insertion point, the medical device, or both based on the trajectory of the model of the medical device within the multi-dimensional depiction.
  11. 11. The method of claim 6, wherein the method carried out by the one or more processors further comprises receiving at least one user input, and in response to that at least one user 15 input, the method further comprises: identifying in the multi-dimensional depiction an insertion point along an interatrial septum; selecting a model representative of the medical device that will pass through the interatrial septum during the performance of the medical procedure; positioning the model of the medical device in the multi-dimensional depiction, wherein the model is positioned within the multi-dimensional depiction relative to the identified insertion point.
  12. 12. A system for selecting a medical device of use in a medical procedure involving a left 25 atrial appendage ("LAA") of a heart of a patient, comprising: an electronic processor; and an electronic memory device electrically coupled to the electronic processor and having instructions stored therein, wherein the processor is configured to access the memory device and execute the 30 instructions stored therein such that it is operable to: acquire image data relating to an anatomical region of interest of a body of the patient; generate a multi-dimensional depiction of the anatomical region of interest using the acquired image data; 31 Date Re9ue/Date Received 2024-02-16 and define a plurality of points relative to the multi-dimensional depiction, wherein at least one of the plurality of points corresponds to a centroid of an anatomical structure of the body of the patient, and further wherein the plurality of points comprises two or more of the following individual points: a point within a true ostium plane that contains a true ostium of the LAA, wherein the point corresponds to the centroid of the true ostium of the LAA; a point within an offset true ostium plane that is a duplicate of and offset from the true ostium plane, wherein the point is offset from the point in the true ostium plane and corresponds to the centroid of the true ostium of the LAA; a point within a fossa ovalis plane that contains the fossa ovalis of the heart of the patient, wherein the point corresponds to the centroid of the fossa ovalis; or a point within an inferior vena cava ("IVC'') plane that contains the IVC ostium of the heart of the patient, wherein the point corresponds to the centroid of the ostium of the IVC; determine one or more measurements based on the defined plurality of points; select a medical device to be used based on the determined measurements, wherein the medical device comprises a catheter to be used to deliver an LAA occlusion device 20 to the LAA of the heart of the patient.
  13. 13. The system of claim 12, wherein the one or more measurements comprise at least one or more of: a distance between the origin of the IVC ostium plane and the origin of the fossa ovalis plane; a distance between the origin of the fossa ovalis plane and the origin of the true ostium plane; an angle defined by the origin of the IVC ostium plane, the origin of the fossa ovalis 30 plane, and the origin of the true ostium plane; and an angle defined by the origin of the fossa ovalis plane, the origin of the true ostium plane, and the origin of the off set true ostium plane. 32 Date Re9ue/Date Received 2024-02-16
  14. 14. The system of claim 13, wherein the measurements further include a distance between a first plane that is a duplicate of and offset from a plane containing a mitral annulus of the heart of the patient and that is aligned with the origin of the true ostium plane, and a second plane that is a duplicate of and offset from the plane containing the mitral annulus and that is 5 aligned with the origin of the fossa ovalis plane.
  15. 15. The system of claim 12, wherein the processor is further operable to: identify in the multi-dimensional depiction an insertion point along an interatrial septum; select a model representative of a medical device that will pass through the interatrial septum during the performance of the medical procedure; positioning the model of the medical device into the multi-dimensional depiction, wherein the model is positioned within the multi-dimensional depiction relative to the identified insertion point; and evaluate the appropriateness of the insertion point, the medical device, or both based on the trajectory of the model of the medical device within the multi-dimensional depiction.
  16. 16. The system of claim 12, wherein in response to one or more user inputs, the processor is further operable to: identify in the multi-dimensional depiction an insertion point along an interatrial septum; select a model representative of a medical device that will pass through the interatrial septum during the performance of the medical procedure; and positioning the model of the medical device in the multi-dimensional depiction, 25 wherein the model is positioned within the multi-dimensional depiction relative to the identified insertion point. 33 Date Re9ue/Date Received 2024-02-16

Description

SELECTING A MEDICAL DEVICE FOR USE IN A MEDICAL PROCEDURE CROSS REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Application No. 62/419,072 5 filed November 8, 2016. TECHNICAL FIELD This disclosure relates generally to periprocedural planning for medical procedures, and more particularly, to periprocedural planning for non-invasive medical procedures involving the heart, including the selection of medical devices to be used in such procedures. BACKGROUND Non-invasive percutaneous implantation of cardiac devices poses certain challenges to physicians. As opposed to surgically invasive procedures, such as, for example, open heart surgery, physicians performing non-invasive cardiac implantation procedures have a limited field of view and are generally limited to guidance during the procedure using images generated 15 by two-dimensional (2D) imaging modalities (e.g., ultrasound, fluoroscopy, etc.). Because physicians are typically limited to 2D imaging during the performance of a procedure, proper periprocedural planning and evaluation is required to accurately assess and determine, for example, the size of certain anatomical structures and the type(s) and/or size(s) of devices to be used during the procedure (e.g., catheters). 20 As with in-procedure guidance, however, conventional periprocedural planning technology has generally been based on imaging platforms and modalities that employ 2D imaging. Accordingly, like the implantation procedure itself, periprocedural planning for such procedures poses challenges to physicians due to the inherent limitations of the conventional 2D imaging that is used. 25 Accordingly, there is a need for a periprocedural planning method and system that minimizes and/or eliminates one or more of the above-identified deficiencies in conventional periprocedural planning methodologies/techniques. 1 Date Re9ue/Date Received 2024-02-16 WO 2018/089461 PCT/0S2017/060592 SUMMARY According to one embodiment, a method for selecting a medical device for use in the performance of a medical procedure is provided. The method comprises acquiring image data relating to an anatomical region of interest of a patient's body, generating a multi-dimensional 5 depiction of the anatomical region of interest using the acquired image data, defining a plurality of points relative to the multi-dimensional depiction, determining one or more measurements based on the defined plurality of points, and selecting a medical device to be used based on the determined measurements. According to another embodiment, a non-transitory, computer-readable storage 10 medium storing instructions thereon is provided. The stored instructions are such that when they are executed by one or more electronic processors, the one or more processors are caused to carry out the method of: acquiring image data relating to an anatomical region of interest of a patient's body; generating a multi-dimensional depiction of the anatomical region of interest using the acquired image data; defining a plurality of points relative to the multi-dimensional 15 depiction; determining one or more measurements based on the defined plurality of points; and selecting a medical device to be used based on the determined measurements. According to yet another embodiment, a system for selecting a medical device of use in a medical procedure is provided. The system comprises an electronic processor and an electronic memory device electrically coupled to the electronic processor and having 20 instructions stored therein. The processor is configured to access the memory device and execute the instructions stored therein such that it is operable to acqmre image data relating to an anatomical region of interest of a patient's body, generate a multi-dimensional depiction of the anatomical region of interest using the acquired image data, define a plurality of points relative to the multi-dimensional depiction, determine one or more measurements 25 based on the defined plurality of points, and select a medical device to be used based on the determined measurements. 2 WO 2018/089461 PCT/0S2017/060592 BRIEF DESCRIPTION OF DRAWINGS One or more embodiments of the invention will hereinafter be described in conjunction with the appended drawings, wherein like designations denote like elements, and wherein: FIG. 1 is a schematic and diagrammatic view a portion of the human heart; FIG. 2 is a schematic and block diagram of an illustrative embodiment of a system for performing one or more embodiments of the methodology described herein; FIG. 3 is a flowchart of an illustrative embodiment of a method that may be used to select or determine a medical device to be used in a medical procedure; FIGS. 4a-4c are computed tomography (CT) images of portions of a patient's heart that 10 may be used, for example, in the performance of one or more steps of the method illustrated in FIG. 3; FIGS. 5-13 are various depictions of models that may be used in th