Left atrial appendage (lAA) transseptal access point optimization

Abstract

One method involves using a processor to identify the septum and left atrial appendage (LAA) of a patient's heart in an anatomical diagram of at least a portion of the heart. An access surface is defined on the anatomical diagram through which a medical device engages with the LAA, the device to be delivered via a sheath penetrating the septum. The normal to the access surface is calculated. Multiple curves are calculated, each curve having (i) an end tangent to the normal, (ii) a second end contacting the septum, and (iii) conforming to specific mechanical properties of the sheath. Multiple candidate locations on the septum are derived from these curves for transseptal puncture using the sheath. These multiple candidate locations are presented to a user.

Description

Technical Field

[0001] This invention relates generally to treatment planning with medical probes, and more specifically to planning the occlusion of the left atrial appendage (LAA) using a transseptal approach with an invasive medical device. Background Technology

[0002] Various methods for planning left atrial appendage (LAA) treatment using catheters have been proposed in patent literature. For example, U.S. Patent Application Publication 2019 / 0090951 describes an ultrasound imager provided for guiding LAA closure. Ultrasound imaging allows for anatomical modeling over time (e.g., throughout the entire cardiac cycle). The anatomical model of the LAA over time is used to create a patient-specific biomechanical model. This personalized model, along with models of one or more closure devices, is used to select a closure device suitable for the patient throughout the entire cardiac cycle and to guide the placement of the selected closure device during implantation. Summary of the Invention

[0003] The embodiments of the invention described below provide a method comprising using a processor to identify the septum and left atrial appendage (LAA) of a patient's heart in an anatomical diagram of at least a portion of the heart. An access surface is defined on the anatomical diagram through which a medical device engages with the LAA, the medical device being delivered via a sheath penetrating the septum. The normal to the access surface is calculated. Multiple curves are calculated, each curve having (i) an end tangent to the normal, (ii) a second end contacting the septum, and (iii) conforming to specific mechanical properties of the sheath. Multiple candidate locations on the septum are derived from these curves for transseptal puncture using the sheath. These multiple candidate locations are presented to a user.

[0004] In some implementations, specific mechanical properties of the sheath include the minimum radius of curvature of the sheath that can be obtained within the heart through external manipulation of the sheath.

[0005] In some implementations, defining the access surface includes: (a) depicting the opening of the LAA on an anatomical diagram, and (b) best fitting the plane to the depicted opening.

[0006] In one implementation, the calculated curve depends on the location where the sheath enters the right atrium (RA) of the heart, whether it comes from the inferior vena cava or the superior vena cava.

[0007] In one embodiment, the medical device is a LAA occlusion device. In another embodiment, the medical device is one of a balloon catheter and a basket catheter.

[0008] In some implementations, uploading the anatomical image involves obtaining it using an invasive ultrasound probe.

[0009] In some implementations, presenting multiple candidate locations includes using a 3D mapping system to present the sheath, entry surface, normal, and candidate location on the diaphragm.

[0010] According to another embodiment of the invention, a system including a memory and a processor is also provided. The memory is configured to store an anatomical diagram of at least a portion of a patient's heart. The processor is configured to: (a) identify the septum and left atrial appendage (LAA) of the heart in the anatomical diagram; (b) define an access surface on the anatomical diagram through which a medical device engages with the LAA, the medical device being delivered via a sheath penetrating the septum; (c) calculate the normal to the access surface; (d) calculate a plurality of curves, each curve (i) having one end tangent to the normal, (ii) having a second end contacting the septum, and (iii) conforming to specific mechanical properties of the sheath; (e) derive a plurality of candidate locations on the septum from these curves for transseptal puncture using the sheath; and (f) present the plurality of candidate locations to a user.

[0011] The invention will be more fully understood through the following detailed description of embodiments thereof, taken in conjunction with the accompanying drawings, wherein: Attached Figure Description

[0012] Figure 1 This is a schematic diagram of a catheter insertion system according to one embodiment of the present invention, the catheter insertion system including a catheter carrying a left atrial appendage (LAA) occlusion device;

[0013] Figure 2 The search for an embodiment of the present invention makes Figure 1 A schematic diagram of a method for diaphragmatic penetration at one or more candidate sites using a catheter sheath; and

[0014] Figure 3 This is an illustrative description of the search for an embodiment of the present invention. Figure 1 A flowchart of a method for diaphragmatic penetration at one or more candidate locations using a catheter sheath. Detailed Implementation

[0015] Overview

[0016] Catheterization is the established treatment for controlling atrial fibrillation (AF) in the left atrium (LA). To access the LA using a catheter, the physician typically first inserts a catheter into the right atrium (RA) via the body's vascular system and uses the catheter sheath to puncture the septum separating the left and right atria. The physician then inserts the sheath through the puncture site into the LA and delivers a medical device (e.g., a catheter) through the sheath to engage with the LA tissue.

[0017] The appropriate choice of transseptal puncture site is important because it has a significant impact on achieving stable contact with the septal wall tissue during invasive treatment, advancing the sheath to the specific LA target location, and maintaining the catheter position at the target LA location.

[0018] Complicating matters further, physicians must carefully consider the transseptal puncture site, as its location can limit how invasive devices (e.g., catheters) can be introduced into the RA. Specifically, the catheter can be introduced into the RA via the inferior vena cava or the superior vena cava, and the choice of these two options depends on the chosen puncture site. Furthermore, the ability to subsequently control the catheter within the LA depends on which distal vein is chosen to enter the body, through which the sheath is navigated to the inferior or superior vena cava of the RA. Therefore, the combination of these considerations, coupled with the patient's given medical profile, can limit the physician's options for successfully performing the intubation procedure in the LA.

[0019] One invasive procedure requiring special consideration via septal puncture site is the occlusion of the left atrial appendage (LAA). This type of procedure is used to reduce the likelihood of blood clots forming in the LAA, which can occur in some patients with atrial fibrillation (AF). The LAA is occluded by a catheter that deploys the LAA occlusion device. The occlusion procedure requires careful alignment of the catheter relative to the corner of the LAA to achieve a successful outcome. However, due to limitations in the flexibility and maneuverability of the sheath and catheter, successfully navigating the catheter from a suboptimal septal puncture site to the LAA is not straightforward.

[0020] The embodiments of the invention described below provide a technique for identifying multiple candidate septal locations and orientations for invasive devices (such as catheters carrying LAA occlusion devices) to accurately engage a given LA target (such as a LAA). Using the disclosed technique allows physicians to consider multiple potential locations for septal penetration, thereby increasing the selection of both clinically effective RA access routes and suitable invasive medical devices (e.g., LAA devices) available to the physician. Such a wider range of options is important, given medical conditions, for example, where the initial selection of catheters for a given patient can limit the physician's choices (e.g., enlarged RA).

[0021] In some implementations, the processor performs the disclosed techniques for finding one or more candidate septal puncture sites to enter the LAA by executing the following steps:

[0022] ■ Generate a 3D anatomical model (e.g., an anatomical diagram) of the relevant regions (e.g., the region surrounding the diaphragm and LAA).

[0023] ■ Taking into account the type of occlusion device and the shape of the LAA, the landing point of the LAA device is defined, i.e., the orifice of the LAA through which the catheter is inserted. Such a landing point is defined, for example, by depicting the orifice of the LAA as a closed curve on a 3D anatomical model.

[0024] ■ Fit an entry surface (e.g., a plane) that is substantially parallel to the depicted LAA port at the landing point, and calculate the normal to that plane.

[0025] ■ Using the predefined mechanical properties of the sheath used for the delivery device, multiple curves are calculated, each curve having (i) an end tangent to the normal, (ii) a second end in contact with the diaphragm, and (iii) conforming to the specific mechanical properties of the sheath.

[0026] ■ Multiple candidate locations on the diaphragm are derived from these curves for transseptal puncture using the sheath, thereby generating one or more corresponding potential entry points for transseptal puncture at one or more corresponding intersections of the curves and the diaphragm.

[0027] ■ Present these multiple candidate locations to the user.

[0028] Examples of mechanical characteristics include the minimum radius of curvature and maximum deflection angle achievable by the sheath, and the location on the sheath that allows the distal end of the sheath to bend (to enter the LAA).

[0029] In one implementation, the processor overlays the identified septal location onto an anatomical map, enabling the physician performing LLA occlusion to select, for example, the most appropriate RA route (e.g., inferior or superior) to reach the LAA using a given LAA occlusion device. The sheath, landing point (e.g., entry surface), normal, and transseptal puncture (also referred to as "entry") point are all mapped in a 3D mapping system (e.g., Visualization in ().

[0030] Typically, a processor is programmed in software containing a specific algorithm that enables the processor to perform each of the processor-related steps and functions described above.

[0031] By identifying one or more candidate septal sites that can be optimally punctured to reach the LAA, the disclosed technique increases the chances of successfully performing invasive LAA surgery for patients with a variety of heart conditions.

[0032] System Description

[0033] Figure 1This is a schematic illustration of a catheter insertion system 20 according to one embodiment of the invention, comprising a catheter 21 carrying a left atrial appendage (LAA) occlusion device 40. A physician 30 inserts the distal end of the catheter shaft 22 through a sheath 23 into the left atrium 45 of the heart 26 of a patient 28 lying on an operating table 29, as seen in illustration 25. During insertion of the shaft 22, the LAA occlusion device 40 is maintained in a collapsed configuration by the sheath 23. By including the LAA occlusion device 40 in the collapsed configuration, the sheath 23 also serves to minimize vascular trauma along the route to the target location.

[0034] To reach the left atrial appendage (LAA) 55 within the left atrium (LA) 45, as seen in illustration 65, the physician 30 first navigates the sheath 23 to the inferior vena cava access route of the right atrium 47. The physician then uses the sheath 23 to puncture a hole 52 in the septum 50 separating the atria by manipulating, for example, a manipulator 32 near the proximal end of the catheter and / or deflecting from the sheath 23. While within the LAA 55, the physician advances the distal end of the shaft 22 via the sheath 23 and deploys an LAA occlusion device 40 coupled to the distal edge of the shaft within the LAA 55.

[0035] Then, the physician 30 uses the catheter handle 31 to manipulate the sheath 23 of the catheter 21 inside the LA 45 to enter and contact the LAA 55. As can be further seen in illustration 65, in order to successfully enter the LAA 55, the physician aligns the sheath 23 in a specific direction 66 toward the opening 57 of the LAA 55.

[0036] The proximal end of catheter 21 is connected to console 24. In the embodiments described herein, catheter 21 can be used for any suitable therapeutic and / or diagnostic purpose, such as electrical sensing in the heart 26, or the aforementioned LAA occlusion, as well as other possible medical uses of such catheters.

[0037] The console 24 includes a processor 41, typically a general-purpose computer, with suitable front-end and interface circuitry 38 for receiving signals from catheter 21, for performing treatment on the heart 26 via catheter 21, and for controlling other components of the system 20. The processor 41 typically includes a general-purpose computer programmed with software to perform the functions described herein. This software can be downloaded electronically to the computer's memory 35 via a network, or alternatively or additionally set and / or stored on a non-transitory tangible medium (such as magnetic storage, optical storage, or electronic storage). Specifically, the processor 41 operates as disclosed herein, including... Figure 3 The dedicated algorithm enables processor 41 to perform the disclosed steps, as further described below.

[0038] Figure 1The exemplary configuration shown is chosen solely for clarity of concept. Other system components and setups can be used to similarly apply the techniques disclosed in this invention. For example, other devices, such as balloon catheters or basket catheters, can be used. Anatomical diagrams can be generated by system 20 employing an invasive ultrasound (US) probe, such as those with… catheter Module generation. As another example, system 20 may include other components, such as additional components for sensing the temperature of heart tissue.

[0039] Optimization of the transseptal entry point for the left atrial appendage (LAA)

[0040] Figure 2 The search for an embodiment of the present invention makes Figure 1 A schematic diagram of a method for penetrating one or more candidate sites of the diaphragm 50 using the sheath 23 of the catheter 21. The right-hand side of the figure is a lateral section of the heart, and the left-hand side is a frontal view of the diaphragm. The aim of this technique is to achieve optimal access to the LAA 55 (shown in anatomical figure 80) using the catheter 21 carrying the LAA occlusion device 40. A suitable way to achieve this is at the defining surface of the orifice, in a direction 66 generally perpendicular to the orifice 57 (e.g., Figure 1 (As shown) the distal end of the shaft 22 of the upper propulsion conduit 21.

[0041] To this end, processor 41 uploads Figure 80 and defines the landing point of the LAA blocking device as plane 70, which the processor fits to the LAA opening 57. As shown, plane 70 is substantially parallel to the LAA opening at the landing point. Then, processor 41 calculates the normal 72 of plane 70.

[0042] Using predefined mechanical properties of the sheath 23 used for delivering the LAA occlusion device 40, such as those illustrated above, the processor 41 calculates multiple curves 74 between the normal 72 and the plane 70 and the diaphragm 50. As described above, each curve 74 (i) has one end tangent to the normal, (ii) has a second end in contact with the diaphragm, and (iii) conforms to specific mechanical properties of the sheath. In this way, the processor creates one or more corresponding potential entry points for transseptal puncture at one or more corresponding intersections of the curves 74 with, for example, one or more corresponding intersections of the plane 76 to which the processor fits to the diaphragm 50. The positions of these multiple potential entry points on the diaphragm 50 are represented by semicircular curves 56, where a specific selection is... Figure 1 The position of 52 on the semicircle 56.

[0043] As shown in the figure, processor 41 overlays potential access points onto the anatomical diagram 80 presented to the physician performing LAA occlusion surgery, to help, for example, select the most appropriate route to reach the LAA via catheter. In this sense, if a sufficiently good diaphragm location is not found, the physician may attempt to model another sheath or the superior vena cava route.

[0044] Figure 2 The exemplary techniques shown are chosen solely for clarity of concept. In particular, curve 56 has been simplified for clarity. Furthermore, different entry paths of RA 47 can generate multiple entirely different potential entry points (e.g., different from curve 56).

[0045] Figure 3 This is a flowchart schematically illustrating a method for finding one or more candidate locations 52 for diaphragmatic penetration of the catheter sheath according to one embodiment of the invention. The process, performed according to the algorithm of the presented embodiment, begins with processor 41 generating (e.g., uploading from memory 35) an anatomical map 80 including the diaphragm 50 and LAA 55 in an anatomical map generation step 90.

[0046] Next, in the landing point definition step 92, the processor 41 defines the landing point of the LAA blocking device 40 by identifying the port 57 of the LAA 55.

[0047] Next, in geometry construction step 94, the processor fits plane 70 to aperture 57 and then calculates the normal 72 of plane 70.

[0048] Using the predefined mechanical properties of the sheath 23 for delivering the LAA plugging device 40, the processor 41 calculates one or more candidate curves 74 between the normal 72 of the plane 70 and the diaphragm 50 in the candidate curve derivation step 96.

[0049] Using curve 74, the processor calculates multiple potential entry points 56 on the diaphragm 50 as described above in step 98 at the transseptal puncture location calculation position.

[0050] Figure 3 The exemplary flowchart shown is chosen solely for the sake of conceptual clarity. For example, additional steps, such as considering another approach to RA 47 and the subsequent repetition of steps 94-98, have been omitted from the intentionally highly simplified flowchart.

[0051] Although the embodiments described herein are primarily for the left atrial appendage, the techniques described herein can also be used in other cardiac catheterization applications of the left atrial appendage, such as electrophysiological mapping and pulmonary vein isolation. In particular, the disclosed techniques can be applied to plan the landing point at the pulmonary vein (PV) ostium for catheters used for electrophysiological sensing and / or ablation (such as balloon catheters, basket catheters, cable catheters, multi-arm catheters, or tip catheters).

[0052] Furthermore, the disclosed technology can be applied to other LA treatment sites (e.g., mitral valve) and other catheter-carrying devices (e.g., artificial valves).

[0053] Therefore, it should be understood that the embodiments described above are cited by way of example, and the invention is not limited to what is specifically shown and described above. Rather, the scope of the invention includes combinations and sub-combinations of the various features described above, as well as variations and modifications thereof, which will occur to those skilled in the art upon reading the above description, and which are not disclosed in the prior art. Documents incorporated herein by reference are considered an integral part of this application, and unless any terminology defined in such incorporated documents conflicts with the definitions expressly or implicitly given in this specification, only the definitions in this specification shall be considered.

Claims

1. A method comprising: The processor is used to identify the septum and left atrial appendage (LAA) of the heart in an anatomical diagram of at least a portion of the patient's heart; An access surface is defined on the anatomical diagram, through which the medical device engages with the LAA, and the medical device is delivered via a sheath that penetrates the septum; Calculate the normal to the surface entering the surface; Calculate multiple curves, each curve having (i) an end tangent to the normal, (ii) a second end in contact with the diaphragm, and (iii) conforming to specific mechanical properties of the sheath; Multiple candidate locations on the diaphragm are derived from the curve for use in transseptal puncture with the sheath; as well as Present the multiple candidate locations to the user.

2. The method according to claim 1, wherein, The specific mechanical properties of the sheath include the minimum radius of curvature of the sheath that can be obtained within the heart through external manipulation of the sheath.

3. The method according to claim 1, wherein, The defined access surface includes: The anatomical diagram depicts the mouth of the LAA; and The plane is best fitted to the depicted opening.

4. The method according to claim 1, wherein, The calculation of the curve depends on whether the sheath enters the right atrium (RA) of the heart from the inferior vena cava or the superior vena cava.

5. The method according to claim 1, wherein, The medical device is an LAA occlusion device.

6. The method according to claim 1, wherein, The medical device is one of a balloon catheter and a basket catheter.

7. The method according to claim 1, wherein, Uploading the anatomical image includes obtaining the anatomical image using an invasive ultrasound probe.

8. The method according to claim 1, wherein, Presenting the multiple candidate locations includes using a 3D mapping system to present the sheath, the entry surface, the normal, and the candidate locations on the diaphragm.

9. A system comprising: A memory configured to store anatomical diagrams of at least a portion of a patient's heart; and Processor, the processor being configured to: Identify the septum and left atrial appendage (LAA) of the heart in the anatomical diagram; An access surface is defined on the anatomical diagram, through which the medical device engages with the LAA, and the medical device is delivered via a sheath that penetrates the septum; Calculate the normal to the surface entering the surface; Calculate multiple curves, each curve having (i) an end tangent to the normal, (ii) a second end in contact with the diaphragm, and (iii) conforming to specific mechanical properties of the sheath; Multiple candidate locations on the diaphragm are derived from the curve for use in transseptal puncture with the sheath; as well as Present the multiple candidate locations to the user.

10. The system according to claim 9, wherein, The specific mechanical properties of the sheath include the minimum radius of curvature of the sheath that can be obtained within the heart through external manipulation of the sheath.

11. The system according to claim 9, wherein, The processor is configured to define the access surface in the following manner: The anatomical diagram depicts the mouth of the LAA; and The plane is best fitted to the depicted opening.

12. The system according to claim 9, wherein, The processor is configured to calculate the curve depending on whether the sheath enters the right atrium (RA) of the heart from the inferior vena cava or the superior vena cava.

13. The system according to claim 9, wherein, The medical device is an LAA occlusion device.

14. The system according to claim 9, wherein, The medical device is one of a balloon catheter and a basket catheter.

15. The system according to claim 9, wherein, The processor is configured to obtain the anatomical map using an invasive ultrasound probe.

16. The system according to claim 9, wherein, The processor is configured to present the plurality of candidate locations by using a 3D mapping system to present the sheath, the entry surface, the normal, and the candidate locations on the diaphragm.

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