APPARATUS, SYSTEMS, AND METHODS FOR OPTIMIZING DELIVERY OF RADIATION TO TREAT CARDIAC ARRHYTHMIAS
20200214763 ยท 2020-07-09
Inventors
Cpc classification
A61B8/12
HUMAN NECESSITIES
A61N5/10
HUMAN NECESSITIES
A61B2034/2063
HUMAN NECESSITIES
A61B6/50
HUMAN NECESSITIES
A61B2018/00375
HUMAN NECESSITIES
A61B8/085
HUMAN NECESSITIES
A61B5/055
HUMAN NECESSITIES
A61B6/5247
HUMAN NECESSITIES
A61B2017/00292
HUMAN NECESSITIES
A61B18/1492
HUMAN NECESSITIES
A61B2018/0212
HUMAN NECESSITIES
A61B2090/3966
HUMAN NECESSITIES
A61B8/4245
HUMAN NECESSITIES
A61B2034/301
HUMAN NECESSITIES
A61B90/39
HUMAN NECESSITIES
International classification
A61B18/12
HUMAN NECESSITIES
A61B18/18
HUMAN NECESSITIES
A61B5/055
HUMAN NECESSITIES
Abstract
Apparatus, systems, and methods are provided for optimizing radiation therapy to a patient to treat cardiac arrhythmias. The system generally includes an ultrasound device placed within the esophagus to image and map cardiac structures in real-time. The system may also control the ventilation of the patient to optimize ultrasound monitoring and radiation delivery.
The device in the esophagus is designed to position and monitor the esophagus and/or nearby structures to optimize radiation delivery to targets while minimizing radiation to other key structures. In addition, different ablation technologies may be delivered from within the esophagus to ablate certain tissues that cannot be safely ablated with radiation therapy. Finally, the esophageal device may have electrical or magnetic properties that can be used to guide the radiation therapy.
Claims
1. An ablation system to treat cardiac dysrhythmias of a heart within a patient's body, comprising: an elongate member having a proximal end and a distal end sized to be placed within an esophagus within the patient's body, the elongate member comprising an energy-delivering portion on the distal end, wherein the energy-delivering portion delivers energy through the esophagus to ablate tissue in order to treat cardiac dysrhythmias.
2. The system of claim 1, wherein the energy-delivering portion is configured to deliver one or more of electroporation energy, focused high intensity ultrasound energy, radiation energy, radiofrequency energy, microwave energy, cryothermal energy, and laser energy.
3. The system of claim 2, wherein the energy-delivering portion is configured to deliver energy to ablate one or more of cardiac tissue, pulmonary vein tissue, and ganglionic plexi.
4. The system of claim 2, further comprising a machine that delivers external radiation therapy from outside the patient's body to ablate tissue in order to treat the cardiac dysrhythmias.
5. The system of claim 2, wherein the energy-delivering portion comprises: at least one electroporation electrode; and an electrical pulse generator electrically coupled to the at least one electroporation electrode.
6. The system of claim 2, wherein the elongate member comprises an ultrasound imaging element carried by the distal end, the system further comprising a processor configured to receive signals from the ultrasound imaging element to generate images to track tissue for ablation.
7. The system of claim 6, wherein the processor is configured to integrate the images from the ultrasound imaging element with magnetic resonance imaging (MRI) or computed tomography (CT) images for image registration to map and track tissue.
8. The system of claim 7, further comprising a ventilator, wherein the ventilator is configured to control the patient's respirations to optimize the ablation procedure.
9. The system of claim 8, further comprising at least one robot, wherein the at least one robot is configured to position or control one or more of the ultrasound imaging device, a machine for delivering radiation therapy, the distal end of the elongate member, and the ventilator.
10. The system of claim 8, wherein the robot is configured to manipulate the distal end of the elongate member to move the esophagus relative to the heart.
11. A system to treat cardiac dysrhythmias in a heart within a patient's body, comprising: an elongate member having a proximal end and a distal end sized to be placed within an esophagus within the patient's body, the elongate member comprising an ultrasound transducer carried by the distal end to track target motion within the patient; a robot configured to control a position of the distal end of the elongate member; a machine designed to deliver radiation therapy to cardiac tissue; and a processor coupled to the robot and the machine to treat cardiac dysrhythmias.
12. The system of claim 11, further comprising a ventilator configured to control the respirations of the patient, wherein the processor is configured to control the ventilator.
13. The system of claim 11, further comprising one or more elements on the distal end of the elongate member configured to deliver electroporation energy from within or near the esophagus to target locations outside the esophagus.
14. (canceled)
15. A method for treating cardiac dysrhythmias in a heart within a patient's body, comprising: providing a radiation delivery machine adjacent the patient's body; introducing a distal end of an elongated member into an esophagus within the patient's body; and selectively delivering electroporation energy from one or more elements on the distal end from within the esophagus and activating the machine to deliver radiation energy into the patient's body such that both electroporation energy and radiation energy are delivered during the same procedure to treat cardiac dysrhythmias.
16. The method of claim 15, wherein the electroporation energy and radiation energy are delivered to ablate one or more of cardiac tissue, pulmonary vein tissue, and ganglionic plexi.
17. The method of claim 15, wherein the electroporation energy and radiation energy are delivered simultaneously.
18. The method of claim 15, wherein the electroporation energy and radiation energy are delivered individually.
19. The method of claim 15, wherein the electroporation energy is delivered through a wall of the esophagus into tissue in the patient's heart.
20. The method of claim 15, further comprising acquiring ultrasound image signals using an imaging element carried by the distal end to generate images to track tissue while delivering the electroporation energy and radiation energy.
21. The method of claim 20, further comprising integrating the images with magnetic resonance imaging (MRI) or computed tomography (CT) images for image registration to map and track the tissue.
22-29. (canceled)
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0029] The invention is best understood from the following detailed description when read in conjunction with the accompanying drawings. It will be appreciated that the exemplary apparatus shown in the drawings are not necessarily drawn to scale, with emphasis instead being placed on illustrating the various aspects and features of the illustrated embodiments.
[0030]
[0031]
[0032]
[0033]
[0034]
[0035]
[0036]
DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS
[0037] Turning to the drawings,
[0038] In accordance with an exemplary embodiment, the system includes a transesophageal device 40, which is shown being positioned within the esophagus 21, and a radiation delivery device (not shown). As described elsewhere herein, the radiation delivery device may be a machine external to the patient that is positioned and oriented towards the patient's body, e.g., operated using a robot or other controller to deliver radiation energy into the patient's body from one or more locations, and/or may be introduced internally, e.g., into the patient's heart 90 as part of the device 40 or as a separate device. Generally, the transesophageal device 40 includes a proximal end (not shown), e.g., including a handle and/or one or more actuators (also not shown), and a distal end sized for introduction into the esophagus 21 that carries one or more sensors, markers, and/or actuatable components, as described elsewhere herein.
[0039] For example, the device 40 may include one or more sensors and/or imaging elements having imaging capabilities (e.g., ultrasound to visualize key structures). The distal end of the device 40 may also include one or more markers, e.g., to function as a fiducial for x-rays or other imaging modalities, e.g., to be linked to a three-dimensional mapping/imaging system, such as ultrasound or impedance-based mapping systems. The device 40 may also have a magnet or one or more electromagnetic elements configured to help facilitate mapping, imaging, or guidance of radiation.
[0040]
[0041] In another embodiment, the distal end of the device 40 (within the esophagus 21) may be actuated to change shape, e.g., to move the esophagus 21 away from the left atrium 11, position the left atrium 11 and pulmonary veins 15, and/or otherwise manipulate the esophagus 21, e.g., such that delivery of radiation is tangential to the esophagus 21. Optionally, the distal end of the device 40 may include one or more elements to generate magnetic forces to further optimize delivery of radiation.
[0042] In another embodiment, the distal end of the transesophageal device 40 may include a positively or negatively charged electrode, or other elements to create an electric field, which may be used to help guide, control, or direct radiation from the radiation delivery device. In another embodiment, one or more charged electrodes may be provided on the distal end to function as a sink to attract radiation or expel radiation away from the device 40 to protect the esophagus 21.
[0043] In another embodiment, the system may include one or more patches that may be placed on the exterior chest of the patient (not shown). The patches and the esophageal device 40 may function as a fiducial for x-ray therapy. In addition or alternatively, the patches and esophageal device 40 may help to create a map using external ultrasound and/or impedance mapping. By combining the fiducials from x-rays with the created map, targets for radiation may be monitored in real-time. Therefore, during the cardiac cycle, patient movement, or patient breathing, real-time monitoring of structures within the patient may facilitate delivery of radiation by the radiation delivery device.
[0044] Turning to
[0045] In addition, the control processor may be connected to an ultrasound transducer, e.g., carried on the distal end of the transesophageal device, which may be positioned within the esophagus. The controller may receive signals from the transducer to track cardiac tissue during the cardiac cycle, as well as based on patient movement (including breathing), e.g., while the distal end and transducer are moved within the esophagus, e.g., by manipulating the transesophageal device from outside the patient's body.
[0046] In addition or alternatively, sometimes it may be desirably to manipulate the distal end of the transesophageal device to move and/or distort the patient's anatomy. For example, the distal end may include one or more expandable members, e.g., balloons, mechanically expandable structures, and the like (not shown), e.g., to increase an outer profile and/or shape of the distal end. In one embodiment, the external aspects of the device may be fixed, while internal components may be actuatable, e.g., using one or more actuators on the proximal end, to move without effecting the patient's anatomy in order to optimize delivery of ablation energy without requiring repeat scans to identify the anatomy.
[0047] In addition, as shown in
[0048] The control processor may also be coupled to one or more electroporation electrodes, e.g., carried on an external radiation delivery device that may be positioned externally on or around the patient's body. In other embodiments, these electrodes may be configured to delivery other forms of ablation energy used to ablate cardiac tissue, such as focused high intensity ultrasound energy, radiation energy, radiofrequency energy, microwave energy, cryothermal energy, laser energy, and the like.
[0049] In addition or alternatively, the control processor may be coupled to a radiation emitter included in an external radiation delivery device. This may be a linear accelerator or other source of radiation. The radiation emitter may be controlled by a robot (not shown) communicating with or contained within the controller to direct radiotherapy to the target structures within the patient's body as determined by the proceduralists).
[0050] In addition, the control processor is also coupled to one or more physiologic sensors, e.g., placed externally to the patient's body. These sensors may include surface electrodes to monitor the cardiac cycle, respiratory sensors to monitor the breathing cycle, movement sensors, and other physiologic sensors. The control processor may combine physiologic sensor data from these sensor(s) with imaging data to track and model how various structures within the patient's body move during the procedure. By modeling how the structures in the patient's body move during the procedure, energy may be delivered to the target locations while minimizing error.
[0051] As shown in
[0052] For example, with additional reference to
[0053] Furthermore, with reference again to
[0054] The control processor may also be coupled to a ventilator. This may be useful because respirations not only move markers or targets that may be provided on the patient's skin or introduced within the heart or elsewhere in the chest cavity, but lung volumes/pressures influence imaging windows and the orientation of structures within the chest. Therefore, the optimal time to deliver radiation therapy may be with the lungs collapsed or fully expanded. In some embodiments, the ventilator is designed to control single lung respiration. In one embodiment, this enables one lung to be collapsed while the other lung is ventilated. By controlling the ventilation, ultrasound imaging, target modeling, and radiation delivery may be optimized by the controller. In some circumstances, the patient is sedated and paralyzed so that the ventilator has complete control over respirations.
[0055] Turning to
[0056] Image processing at step 54 may include various filtering modalities, various mapping techniques, gamma correction, image enhancement, spectral processing, and/or the like. The image data from the various modalities are combined with the data from the physiologic sensors and undergo image processing 54. Once the image processing 54 has been combined with physiologic sensors data 53, these data undergo image registration 58. Image registration 58 generally involves spatially transforming the various images to align with the target image. In some cases, the target and surrounding tissue are determined a priori utilizing an imaging modality. This imaging is used to create a treatment plan 59.
[0057] The treatment plan 59 may include identifying the target volume or location, and the desired dose to the target is prescribed. Sensitive tissue structures (or critical structures) in the vicinity of the target are also delineated and may be assigned a maximum dose that can be deposited to these structures. A computer program, e.g., within the controller of the system or an external device communicating with the controller, then receives the various targets and critical structures, the prescribed doses, the geometric configuration of the radiation delivery system, and the ventilation control 70 in order to compute the position and orientation of beams from the radiation delivery device paired with the ventilation in order to determine and optimize the treatment plan 59. The computer program also determines the radiation dose received by all tissue. This data can be reviewed by the proceduralist(s) to verify the radiation to the target and critical structures. The treatment plan 59, image registration 58, and ventilation control 70 are all then combined to validate motion and treatment 71.
[0058] Once the treatment plan has been validated, ablation therapy may be delivered to treat the patient at step 72. In an exemplary embodiment, treating the patient may include delivering radiation therapy and/or other ablation technologies from within the esophagus, e.g., using one or more treatment elements carried by the distal end of the transesophageal device. The treatment may also include using one or more robots, e.g., to control patient ventilation as well as the ablation technologies, e.g., one or both external to the patient and from within the esophagus. The proceduralist(s) must also verify the plan for ventilation control 70 is appropriate for the patient receiving therapy. This may include collapsing a lung, prolonged breath holds, hyperventilation, and the like in order to optimize the ablation procedure. However, certain maneuvers or duration may not be safe for all patients. Therefore, the proceduralist(s) must verify all aspects of the plan before proceeding with the treatment.
[0059] Turning to
[0060] As shown in the detail of
[0061] In addition, the elongated member 65 may also carry one or more electrodes 42 on the distal end 65a. These electrodes 42 may be used to deliver electroporation ablation to the target structures. These electrodes 42 may be configured in various shapes and sizes, including elongated electrodes used in various other electroporation ablation procedures. Furthermore, these or other electrodes may be provided on the distal end 65a to monitor physiological signals to guide the ablation procedure. In some embodiments, the system also includes ventilation control 70 (not shown), similar to other embodiments described herein. In addition, the patient 91 will be closely monitored during the ablation procedure, including pulse oximetry, heart rate, and blood pressure (not shown.
[0062] Turning to
[0063] Optionally, the elongated member 65 may also include a motorized control portion 66, e.g., on the distal end, capable of moving the esophagus 21 in space and/or rotating the esophagus 21 when actuated. Alternatively, the motorized control portion 66 may move components inside of the elongated member 65 without affecting the esophagus 21.
[0064] In some embodiments, the elongated member 65 may include one or more chambers 44 carried on or within the distal end, e.g., defined by balloons or other enclosed structures, e.g., formed from compliant, non-compliant, or substantially non-compliant material. Gas, water, or other fluid may be introduced into and/or removed from the chambers 44 to selectively expand and contract the structures. For example, by inflating one or more of the chambers 44, the distal end of the elongated member 65 may have better contact with the esophagus 21 or have better control in moving the esophagus 21.
[0065] Furthermore, in some embodiments, the elongated member 65 may include one or more lumens 45 extending between the proximal and distal ends of the elongated member 65. These lumens 45 may have access to the gastric fluid or provide the ability to inflate or deflate one or more of the chambers 44. In some embodiments, inflation of one chamber 44 will move the esophagus 21 in one direction while inflation of another chamber 44 will move the esophagus in the opposite direction. This movement may be performed with or without the support of the motorized control portion 66. In addition, the esophagus 21 may be selectively manipulated using the various described mechanisms in combination with the ventilation control 70, since respiration and intrathoracic pressure affects the ability to move the esophagus in relation to the heart 90. In addition, in some embodiments, the lumens 45 may contain electromagnetic material, which may create a magnetic field capable of directing charged radiation away from critical tissue and towards target structures.
[0066] Optionally, the elongated member 65 may carry one or more electroporation electrodes 42 on the distal end. In addition or alternatively, the elongated member 65 may have a variety of energy-delivering portions, including focused high intensity ultrasound energy, radiation energy, radiofrequency energy, microwave energy, cryothermal energy, and laser energy. Electroporation ablation is tissue specific and can safely ablate nearby tissue without critical damage to the esophagus 21. In some cases, a plurality of electrodes 42 are positioned spaced apart along the distal end of the elongated member 65. However, in other embodiments, at least one electrode 42 may be provided to deliver the electroporation ablation. These electrodes 42 may then be coupled to an electrical pulse generator, e.g., via the controller, to deliver ablation energy. By combining some form of ablation from the esophagus 21 with an external radiotherapy device 61, a complete ablation procedure may be performed without substantial risk of injury to critical tissues, including the esophagus 21.
[0067] In some embodiments, the ablation procedure may be performed with the patient intubated, sedated, and/or on a ventilator and be used to treat a variety of cardiac dysrhythmias, including atrial fibrillation. The ablation energy from the elongated member 65 may be used to ablate cardiac tissue, pulmonary vein tissue, and/or ganglionic plexi, as prescribed by the proceduralist(s). Controlling ventilation is paramount for the ablation procedure. Lung volumes influence the relationship between the left atrium 11 and the esophagus 21. The volumes influence the angles of radiation ablation as well as the ability of ultrasound transducer 41 to map and tract tissue. Therefore, in some embodiments, a processor (not shown) controls the ventilator (not shown) in order to optimize the ablation procedure. Furthermore, in some situations the esophagus 21 may need to be moved. Therefore, in some embodiments, a motorized control portion and/or robot 66 may be coupled to the distal end of the elongated member 65, which may manipulate the distal end to position or control the elongated member 65. The robot 66 may be used to move the esophagus 21 relative to the heart 90.
[0068] The external radiation source 61 (shown in
[0069] Similar to other embodiments herein, the elongated member 65 may also include an ultrasound transducer 41 carried on the distal end. The images from the ultrasound transducer 41 may be used for image registration with other imaging modalities such as MRI or CT images by a controller (not shown), also similar to other embodiments herein. The images from the ultrasound transducer 41 may be used to map and track tissue for ablation, both from within the esophagus 21 or externally.
[0070] It will be appreciated that elements or components shown with any embodiment herein are exemplary for the specific embodiment and may be used on or in combination with other embodiments disclosed herein.
[0071] While the invention is susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular forms or methods disclosed, but to the contrary, the invention is to cover all modifications, equivalents and alternatives falling within the scope of the appended claims.