Patent Issued for Selecting A Medical Device For Use In A Medical Procedure (USPTO 10,792,104)

2020 OCT 20 (NewsRx) -- By a News Reporter-Staff News Editor at Insurance Daily News -- According to news reporting originating from Alexandria, Virginia, by NewsRx journalists, a patent by the inventors Wang, Dee Dee (Ann Arbor, MI); Forbes, Michael (Dearborn, MI); Myers, Eric (Ferndale, MI); O’Neill, William (Grosse Pointe Farms, MI), filed on November 8, 2017, was published online on October 19, 2020.

The assignee for this patent, patent number 10,792,104, is Henry Ford Health System (Detroit, Michigan, United States).

Reporters obtained the following quote from the background information supplied by the inventors: “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 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).

“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.

“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.”

In addition to obtaining background information on this patent, NewsRx editors also obtained the inventors’ summary information for this patent: “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 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 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 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 instructions stored therein. The processor is configured to access the memory device and execute the instructions stored therein such that it is operable to acquire 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 based on the defined plurality of points, and select a medical device to be used based on the determined measurements.”

The claims supplied by the inventors are:

“The invention claimed is:

“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 patient’s heart, comprising: 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 depiction, wherein at least one of the plurality of points corresponds to a centroid of an anatomical structure of the patient’s body, the plurality of points comprising two or more of the following individual points: a point within a 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 a 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 plane that contains the fossa ovalis of the patient’s heart, wherein the point corresponds to the centroid of the fossa ovalis; or a point within a plane that contains the inferior vena cava (“IVC”) ostium of the patient’s heart, 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 delivery an LAA occlusion device to the LAA of the patient’s heart.

“2. The method of claim 1, wherein the measurement(s) determined in the determining step comprise(s) at least one of: a distance between the point within the IVC ostium plane corresponding to the centroid of the ostium of the IVC and the point within the fossa ovalis plane corresponding to the centroid of the fossa ovalis; a distance between the point within the fossa ovalis plane corresponding to the centroid of the fossa ovalis and the point within the true ostium plane corresponding to the centroid of the true ostium of the LAA; an angle defined by the point within the IVC ostium plane corresponding to the centroid of the IVC ostium, the point within the fossa ovalis plane corresponding to the centroid of the fossa ovalis, and the point within the true ostium plane corresponding to the centroid of the true ostium of the LAA, wherein the point within the fossa ovalis plane corresponding to the centroid of the fossa ovalis is the vertex of the angle; or an angle defined by the point within the fossa ovalis plane corresponding to the centroid of the fossa ovalis, the point within the true ostium plane corresponding to the centroid of the true ostium of the LAA, and the point within the offset true ostium plane corresponding to the centroid of the true ostium of the LAA, wherein the point within the true ostium plane corresponding to the centroid of the true ostium of the LAA is the vertex of the angle.

“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 the mitral annulus of the patient’s heart and that is aligned with the point within the true ostium plane corresponding to the centroid of true ostium of the LAA, and a second plane that is a duplicate of and offset from the plane containing the mitral annulus and that is aligned with the point within the fossa ovalis plane corresponding to the centroid of the fossa ovalis.

“4. The method of claim 1, further comprising: identifying in the depiction an insertion point along the interatrial septum; selecting a model representative of a medical device that will pass through the interatrial septum during the performance of the medical procedure; importing the model of the medical device into the depiction, wherein the model is positioned within the depiction relative to the identified insertion point; and evaluating the appropriateness of the insertion point, the medical device, or both based on a trajectory of the model of the medical device within the depiction.

“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 depiction an insertion point along the interatrial septum; selecting a model representative of a medical device that will pass through the interatrial septum during the performance of the medical procedure; importing the model of the medical device into the depiction, wherein the model is positioned within the depiction relative to the identified insertion point.

“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 the performance of a medical procedure involving a left atrial appendage (“LAA”) of a patient’s heart, wherein the method comprises: 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 depiction, wherein at least one of the plurality of points corresponds to a centroid of an anatomical structure of the patient’s body, the plurality of points comprises two or more of the following individual points: a point within a 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 a 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 plane that contains the fossa ovalis of the patient’s heart, wherein the point corresponds to the centroid of the fossa ovalis; or a point within a plane that contains the inferior vena cava (“IVC”) ostium of the patient’s heart, 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 delivery an LAA occlusion device to the LAA of the patient’s heart.

“7. The storage medium of claim 6, wherein the measurement(s) comprise(s) at least one of: a distance between the point within the IVC ostium plane corresponding to the centroid of the ostium of the IVC and the point within the fossa ovalis plane corresponding to the centroid of the fossa ovalis; a distance between the point within the fossa ovalis plane corresponding to the centroid of the fossa ovalis and the point within the true ostium plane corresponding to the centroid of the true ostium of the LAA; an angle defined by the point within the IVC ostium plane corresponding to the centroid of the IVC ostium, the point within the fossa ovalis plane corresponding to the centroid of the fossa ovalis, and the point within the true ostium plane corresponding to the centroid of the true ostium of the LAA, wherein the point within the fossa ovalis plane corresponding to the centroid of the fossa ovalis is the vertex of the angle; or an angle defined by the point within the fossa ovalis plane corresponding to the centroid of the fossa ovalis, the point within the true ostium plane corresponding to the centroid of the true ostium of the LAA, and the point within the offset true ostium plane corresponding to the centroid of the true ostium of the LAA, wherein the point within the true ostium plane corresponding to the centroid of the true ostium of the LAA is the vertex of the angle.

“8. The method of claim 6, wherein the method carried out by the one or more processors further comprises: identifying in the depiction an insertion point along the interatrial septum; selecting a model representative of a medical device that will pass through the interatrial septum during the performance of the medical procedure; importing the model of the medical device into the depiction, wherein the model is positioned within the depiction relative to the identified insertion point; and evaluating the appropriateness of the insertion point, the medical device, or both based on a trajectory of the model of the medical device within the depiction.

“9. 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 input, the method further comprises: identifying in the depiction an insertion point along the interatrial septum; selecting a model representative of a medical device that will pass through the interatrial septum during the performance of the medical procedure; importing the model of the medical device into the depiction, wherein the model is positioned within the depiction relative to the identified insertion point.

“10. A system for selecting a medical device of use in a medical procedure involving the left atrial appendage (“LAA”), 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 instructions stored therein such that it is operable to: acquire 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, wherein at least one of the plurality of points corresponds to a centroid of an anatomical structure of the patient’s body, the plurality of points comprising two or more of the following individual points: a point within a 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 a 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 plane that contains the fossa ovalis of the patient’s heart, wherein the point corresponds to the centroid of the fossa ovalis; or a point within a plane that contains the inferior vena cava (“IVC”) ostium of the patient’s heart, 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; and select a medical device to be used based on the determined measurements, wherein the medical device comprises a catheter to be used to delivery an LAA occlusion device to the LAA of the patient’s heart.

“11. The system of claim 10, wherein the measurement(s) comprise at least one of: a distance between the point within the IVC ostium plane corresponding to the centroid of the ostium of the IVC and the point within the fossa ovalis plane corresponding to the centroid of the fossa ovalis; a distance between the point within the fossa ovalis plane corresponding to the centroid of the fossa ovalis and the point within the true ostium plane corresponding to the centroid of the true ostium of the LAA; an angle defined by the point within the IVC ostium plane corresponding to the centroid of the IVC ostium, the point within the fossa ovalis plane corresponding to the centroid of the fossa ovalis, and the point within the true ostium plane corresponding to the centroid of the true ostium of the LAA, wherein the point within the fossa ovalis plane corresponding to the centroid of the fossa ovalis is the vertex of the angle; or an angle defined by the point within the fossa ovalis plane corresponding to the centroid of the fossa ovalis, the point within the true ostium plane corresponding to the centroid of the true ostium of the LAA, and the point within the offset true ostium plane corresponding to the centroid of the true ostium of the LAA, wherein the point within the true ostium plane corresponding to the centroid of the true ostium of the LAA is the vertex of the angle.

“12. The system of claim 11, wherein the measurements further include a distance between a first plane that is a duplicate of and offset from a plane containing the mitral annulus of the patient’s heart and that is aligned with the point within the true ostium plane corresponding to the centroid of true ostium of the LAA, and a second plane that is a duplicate of and offset from the plane containing the mitral annulus and that is aligned with the point within the fossa ovalis plane corresponding to the centroid of the fossa ovalis.

“13. The system of claim 10, wherein the processor is further operable to: identify in the depiction an insertion point along the interatrial septum; select a model representative of a medical device that will pass through the interatrial septum during the performance of the medical procedure; import the model of the medical device into the depiction, wherein the model is positioned within the depiction relative to the identified insertion point; and evaluate the appropriateness of the insertion point, the medical device, or both based on a trajectory of the model of the medical device within the depiction.

“14. The system of claim 10, wherein in response to one or more user inputs, the processor is further operable to: identify in the depiction an insertion point along the 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 import the model of the medical device into the depiction, wherein the model is positioned within the depiction relative to the identified insertion point.”

For more information, see this patent: Wang, Dee Dee; Forbes, Michael; Myers, Eric; O’Neill, William. Selecting A Medical Device For Use In A Medical Procedure. U.S. Patent Number 10,792,104, filed November 8, 2017, and published online on October 19, 2020. Patent URL: http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=10,792,104.PN.&OS=PN/10,792,104RS=PN/10,792,104

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