Blockage Detection via Fluid Dilution

Abstract

The present invention is titled "Occlusion Detection via Fluid Dilution". The present invention discloses an occlusion detection method. The method includes the step of positioning a medical tool coupled to a distal portion of a distal end of a delivery catheter at a target cavity within a patient. The medical tool includes an inflatable balloon and at least one sensor. The inflatable balloon is inflated when positioned at the target cavity. The inflatable balloon includes a membrane formed by a plurality of perfusion pores. Fluid is introduced into the target cavity by injection or through the pores or both. Using the sensor, a characteristic of blood in the target cavity is detected. The characteristic of the blood is processed to determine the presence or absence of an occlusion within the cavity.

Description

[0001] Cross - Reference to Related Applications

[0002] This patent application claims the benefit of U.S. Provisional Application No. 62 / 786,957, filed on December 31, 2018, and U.S. Provisional Application No. 62 / 786,997, filed on December 31, 2018, the contents of which are hereby incorporated by reference herein.

[0003] This application incorporates by reference the contents of a non - provisional application titled "Occlusion Detection By Pressure Measurement" filed on the same date as this application, as if fully set forth herein. This non - provisional application claims the benefit of U.S. Provisional Application No. 62 / 786,982, filed on December 31, 2018. This application incorporates the contents of this provisional application by reference herein, as if fully set forth herein. BACKGROUND OF THE INVENTION

[0004] The present invention relates to fluid dilution systems and methods for detecting occlusions within cardiac cavities. However, it should be understood that the systems, devices, and methods of the present invention are not limited to detecting occlusions within cardiac cavities. Additionally, the present invention can be used to determine occlusions in other parts of the body, such as blood clots in the brain. The fluid dilution systems, devices, and methods of the present invention are disclosed in two exemplary embodiments.

[0005] According to a first exemplary embodiment, the fluid dilution systems, devices, and methods are used to detect occlusions of the pulmonary veins ("PV") or other cardiac cavities during ablation of cardiac tissue. Ablation of cardiac tissue has been used to treat arrhythmias. Ablation energy is typically delivered to cardiac tissue by a distal portion that can be advanced along the tissue to be ablated. Some of these catheters deliver ablation energy from various electrode three - dimensional structures. Fluoroscopy can be used to visualize ablation procedures incorporating such catheters.

[0006] According to a second exemplary embodiment, the fluid dilution systems, devices, and methods are used to detect occlusions of the left atrial appendage or left atrium as part of reducing the risks associated with atrial fibrillation. The upper chambers of the heart (i.e., the atria) are each attached to an atrial appendage. For example, the left atrial appendage is a characteristic structure in all human heart structures. The physiological function of such atrial appendages is not fully understood, but the atrial appendages do serve to store blood during normal pumping of the heart. The atrial appendages typically project from the atria and cover an exterior portion of the atria. The atrial appendages are substantially different from one another. For example, one atrial appendage may be configured as a conical projection, and another atrial appendage may be configured as a recessed sock - like opening. There is typically a septum between the inner surface of the atrial appendage and the fibers of the myocardial tissue, and one or more lobules of the myocardial tissue fibers traverse the surface of the atrial appendage.

[0007] When the heart pumps blood through the auricles during normal operation, the auricles do not seem to function. In other words, during normal operation of the heart, the auricles do not exhibit a significant effect on the blood being pumped through them. However, during atrial fibrillation, once atrial arrhythmia occurs, blood may pool inside the auricles and then form thrombi. In addition, if this phenomenon occurs in the left auricle, it may pose a risk of stroke because once normal sinus rhythm resumes after an arrhythmia event, the thrombus may be pumped out of the heart and into the cranial circulation.

[0008] In the past, the auricles were sometimes surgically corrected to reduce the risks caused by atrial fibrillation. In recent years, devices that can be delivered percutaneously into the left auricle have been introduced. The basic function of these devices is to exclude the space inside the auricle with an implant, which can then enable the blood inside the auricle to safely form thrombi and then gradually incorporate into the heart tissue. This process, combined with the growth of endothelium above the surface of the device, can leave a smooth endothelialized surface at the location of the auricle. Compared with surgical procedures used to address problems related to the left auricle, percutaneous implant devices for the same purpose are less invasive methods.

[0009] Generally speaking, occlusion is detected by injecting a contrast fluid into a target cavity such as the pulmonary vein or the left atrium and observing whether the contrast fluid leaks out of the target cavity. However, the contrast fluid has several drawbacks, such as allergic reactions. Therefore, it is advantageous to provide systems, methods, and / or devices that can perform occlusion detection in the pulmonary vein, left auricle, left atrium, and other cavities of the heart, as well as other parts of the human body, without using a contrast fluid. Summary of the Invention

[0010] According to a first exemplary embodiment, a system, apparatus, and method for occlusions detection within a pulmonary vein are disclosed. The system for occlusions detection may include a sheath extending a length in a proximal-distal direction, the sheath including a lumen defined by a sheath wall. The system also includes a delivery system including a catheter extending between a proximal end and a distal end, and a handle coupled to the proximal end of the catheter, the catheter including an internal lumen. The system also includes a medical tool including an inflatable balloon couplable to the sheath. The inflatable balloon includes a distal end and a proximal end defining a longitudinal axis. At least one sensor is configured to sense at least one characteristic of blood located within a target cavity, and at least one processor is configured to process blood characteristic data obtained from the at least one sensor. According to the method, the medical tool is positioned at a target location within a portion of a patient's organ. The method may include inflating the inflatable balloon of the medical tool, injecting fluid through the internal lumen of the catheter, detecting at least one characteristic of blood in the target cavity via the at least one sensor, and processing the at least one characteristic of the blood via the processor. The presence or absence of a characteristic may be determined by the at least one characteristic of the blood. Injecting a fluid such as saline may change the at least one characteristic of the blood within the target cavity. Thus, a change in the at least one characteristic of the blood may indicate the presence or absence of an occlusion.

[0011] According to a second exemplary embodiment, a system and method for detecting an occlusion within a left atrial appendage, within a left atrium, within other cardiac cavities, or within other parts of a human body are disclosed. The system may include a sheath, a delivery system, a medical tool, at least one sensor, and a processor. The sheath has a length and a sheath lumen extending through the length of the sheath. The delivery system may include a delivery catheter extending between a proximal end and a distal end, and a handle coupled to the proximal end of the delivery catheter. The medical tool is coupled to the distal end of the delivery catheter at a target location within a portion of a patient's organ. The medical tool may include a hub including a bore defining an axis; and an occluder portion coupled to the hub. The occluder portion may be configured to move between a non-deployed position in which the occluder portion is positioned within a distal portion of the sheath and a deployed position when the sheath is moved proximally relative to the occluder portion. An anchor portion may be provided extending between a first end coupled to the handle and a second end pivotally couplable to the distal end of the occluder portion. The anchor portion is capable of pivoting between an anchor non-deployed position and an anchor deployed position relative to the occluder portion when the occluder portion is held in the deployed position. The at least one sensor may be configured to detect at least one physical characteristic of blood. The processor may be configured to process blood characteristic data obtained from the at least one sensor. The system may be used to make measurements simultaneously within the left atrial appendage, the left atrium, or both the left atrial appendage and the left atrium.

[0012] The method of the second exemplary embodiment includes positioning a medical tool at a target location within a portion of an organ of a patient. The medical tool may include an occluder portion, an anchor portion, a tissue growth member, and a hub. The method includes deploying the occluder portion to an expanded deployment position, actuating the anchor portion from a retracted position to an anchor deployment position, and injecting a fluid through a delivery catheter and through the hub of the medical tool and into the target cavity. The tissue growth member prevents the fluid from leaving the cavity. The method includes detecting at least one characteristic of blood in the target cavity via the at least one sensor, and processing the at least one characteristic of the blood data via a processor, wherein the presence or absence of a blockage is determined by the at least one characteristic of the blood. Injecting a fluid such as saline can change the at least one characteristic of the blood within the target cavity. Accordingly, a change in the at least one characteristic of the blood can indicate the presence or absence of a blockage. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Figure 1 is a schematic view of an invasive medical procedure including a medical tool having an inflatable balloon according to a first exemplary embodiment of the present invention;

[0014] Figure 2 is a top view of a catheter having a balloon in an inflated state according to the first exemplary embodiment, the catheter being used with a snare catheter extending from a distal portion of the balloon;

[0015] Figure 3 is Figure 2 a perspective view of the balloon together with the snare catheter extending from the distal portion of the balloon;

[0016] Figure 4 is a side view of a distal end of a catheter deployed in a pulmonary vein and its ostial region Figure 2 thereof;

[0017] Figure 5 is Figure 3 a top plan view of a plurality of flexible circuit electrode assemblies prior to being assembled onto a balloon thereof, wherein the electrodes of each assembly include sensors for sensing blood characteristics such as temperature, impedance, or pH, the sensors being located at the center of each electrode;

[0018] Figure 5A is Figure 3 a top plan view of a plurality of flexible circuit electrode assemblies prior to being assembled onto a balloon thereof, the plurality of flexible circuit electrode assemblies including radio-opaque markers;

[0019] Figure 5B is Figure 5A a representation of a fluoroscopic image of a balloon including Figure 3 thereof;

[0020] Figure 6 is a perspective detail view of a flexible circuit electrode assembly after being assembled onto a Figure 3 balloon;

[0021] Figure 7 is a block diagram showing example components of a medical tool for occlusion detection according to a first exemplary embodiment of the present invention;

[0022] Figure 8 is a side view of a medical tool according to a first exemplary embodiment of the present invention located near a pulmonary vein;

[0023] Figure 8A graphically shows experimental results using a first exemplary embodiment on a model simulating a pulmonary vein;

[0024] Figure 8B graphically shows the results of an experiment conducted using a first exemplary embodiment;

[0025] Figure 8C is a side view of an inflatable balloon according to a first exemplary embodiment deployed near a pulmonary vein and its orifice;

[0026] Figure 8D graphically shows the results of an experiment;

[0027] Figure 9 is a flowchart showing a method for occlusion detection according to a first exemplary embodiment of the present invention;

[0028] Figure 10 is a flowchart showing a method for determining a patient baseline measurement for occlusion detection according to a first exemplary embodiment of the present invention;

[0029] Figure 11 is a perspective view of a medical tool and a distal portion of a delivery system according to a second exemplary embodiment of the present invention;

[0030] Figure 11A is along Figure 11 a partial cross-sectional view of the medical tool taken along section line 11A;

[0031] Figure 11B is an enlarged cross-sectional view of a occluder portion taken from detail 11B according to a second exemplary embodiment of the present invention by Figure 11A ;

[0032] Figure 12 is a perspective view of a medical tool according to a second exemplary embodiment of the present invention Figure 11 depicting a frame without a tissue growth member;

[0033] Figure 13 isFigure 12 Top view of the frame member of the occluder portion and the anchor portion of the medical tool, depicting the frame member before assembly cut from a flat sheet by laser;

[0034] Figure 13A is Figure 13 Partial enlarged view of the anchor portion depicted;

[0035] Figure 13B Enlarged view of the hinge coupling between the occluder portion and the anchor portion of the medical tool;

[0036] Figure 14 Perspective view of a medical tool delivery system according to a second exemplary embodiment of the present invention;

[0037] Figure 15 Side view of the end portion of a delivery catheter according to a second exemplary embodiment of the present invention;

[0038] Figure 15A is along Figure 15 Cross-sectional view of the end portion of the delivery catheter taken along the longitudinal axis of the delivery catheter;

[0039] Figure 15B Enlarged view of the end portion of the delivery catheter;

[0040] Figures 16A - 16C Perspective view of a loader according to a second exemplary embodiment of the present invention, depicting the following operations respectively: pushing the loader above the occluder portion of the medical tool, inserting the medical tool into the sheath, and pushing to the distal end of the sheath;

[0041] Figure 17 Side view of the distal portion of a sheath according to a second exemplary embodiment of the present invention, showing a part of the medical tool exposed at the distal end of the sheath in the left atrial appendage (LAA);

[0042] Figure 18 Cross-sectional side view of the distal portion of the delivery system and the medical tool according to a second exemplary embodiment of the present invention, depicting the withdrawal of the sheath to deploy the occluder portion of the medical tool in the LAA, and also depicting the anchor portion in the non-deployed position of the anchor;

[0043] Figure 18A Side view of a handle according to a second exemplary embodiment of the present invention, depicting the handle in a first position corresponding to the non-deployed position of the anchor;

[0044] Figure 19A cross-sectional side view of a distal portion of a delivery system and a medical tool according to a second exemplary embodiment of the present invention, depicting both a occluder portion located in the LAA and an anchor portion in an anchor deployment position;

[0045] Figure 19A A side view of a handle according to a second exemplary embodiment of the present invention, depicting the handle in a second position corresponding to the anchor deployment position;

[0046] Figure 20 A cross-sectional side view of a distal portion of a delivery system and a medical tool according to a second exemplary embodiment of the present invention, depicting the delivery system being released from the medical tool in the LAA;

[0047] Figure 20A A side view of a handle according to a second exemplary embodiment of the present invention, depicting a portion of the handle rotating for releasing the medical tool;

[0048] Figure 20B A side view of a handle according to a second exemplary embodiment of the present invention, depicting a portion of the handle being actuated from a second position to a first position;

[0049] Figure 21 A cross-sectional side view of a distal portion of a delivery system and a medical tool according to a second exemplary embodiment of the present invention, depicting the delivery catheter being completely released from the medical tool;

[0050] Figure 22 A partial perspective view of a proximal side of a medical tool according to a second exemplary embodiment of the present invention, the proximal side being coupled to a delivery system;

[0051] Figure 23A and Figure 23B A cross-sectional side view of a handle according to a second exemplary embodiment of the present invention, depicting a release button in a first position and a second position respectively to facilitate actuation of a plunger shaft;

[0052] Figure 24A and Figure 24B A simplified side profile view of another embodiment of a medical tool, depicting the medical tool in an anchor non-deployment position and an anchor deployment position respectively;

[0053] Figure 25 is Figure 24A and Figure 24B A top view of the occluder portion and the anchor portion of the medical tool, depicting a frame member cut from a flat sheet;

[0054] Figure 26A and Figure 26Bis a simplified side profile view of a medical tool, depicting the medical tool in an anchor non-deployed position and an anchor deployed position, respectively;

[0055] Figure 27 is Figure 26A and Figure 26B top views of the occluder portion and the anchor portion of the medical tool, depicting a frame member cut from a flat sheet;

[0056] Figure 28 is a perspective view of a medical tool delivery system according to a second exemplary embodiment of the present invention, depicting the medical tool attached and deployed at the distal end of the delivery system;

[0057] Figure 28A is according to another embodiment of the present invention Figure 28 a cross-sectional view of section 28A, depicting a lumen defined in the proximal portion of the catheter of the delivery system;

[0058] Figure 28B is according to another embodiment of the present invention Figure 28 a cross-sectional view of section 28B, depicting a sheath lumen of the sheath of the catheter of the delivery system therein;

[0059] Figure 29 is a cross-sectional view of the medical tool and the distal portion of the delivery system according to the second exemplary embodiment of the present invention, depicting fluid flowing from the hub of the medical tool into the left atrial appendage;

[0060] Figure 30 is an enlarged cross-sectional view of the distal portion of the delivery system and the hub of the medical tool (with the occluder portion removed for simplicity) according to the second exemplary embodiment of the present invention, depicting the flow path of fluid through the delivery system and the hub of the medical tool;

[0061] Figure 30A is along Figure 30 an enlarged cross-sectional view taken along region 30A, depicting the flow path of fluid at the distal portion of the delivery system;

[0062] Figure 30B is along Figure 20 an enlarged cross-sectional view taken along region 30B, depicting the flow path of fluid at the hub of the medical tool;

[0063] Figure 31 is a block diagram showing exemplary components of a medical system for occlusion detection according to the second exemplary embodiment of the present invention;

[0064] Figure 32 is a flowchart showing a method for occlusion detection according to the second exemplary embodiment of the present invention; and

[0065] Figure 33 It is a flowchart showing a method for determining a patient baseline measurement for occlusion detection according to a second exemplary embodiment of the present invention. Detailed Description

[0066] The following detailed description should be read in conjunction with the accompanying drawings, in which like numerals in different drawings refer to like elements. The drawings (not necessarily to scale) illustrate selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates the principles of the invention in an illustrative, but not restrictive, manner. This description will clearly enable those skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives, and uses of the invention, including what is presently believed to be the best mode of carrying out the invention.

[0067] As used herein, the term "about" or "approximately" for any numerical value or range indicates a suitable dimensional tolerance that allows a collection of components or elements to achieve its intended purpose as described herein. More specifically, "about" or "approximately" can refer to a range of values ±10% of the recited value; for example, "about 90%" can refer to a range of values from 81% to 99%. The terms "distal" and "proximal" are used to indicate the spatial relationship of various components to the operator. For example, a distal component indicates a component that is farther from the operator, while a proximal component indicates that it is closer to the operator. Additionally, as used herein, the terms "patient," "host," "user," and "subject" refer to any human or animal subject, and are not intended to limit the system or method to human use, but the use of the subject invention in human patients represents a preferred embodiment.

[0068] According to a first exemplary embodiment, a system for occlusion detection may include a sheath having a tube defined by a sheath wall, the sheath extending a length in a proximal - distal direction. The system may also include a delivery system that includes a catheter extending between a proximal end and a distal end, and a handle coupled to the proximal end of the catheter, the catheter including an internal lumen. The system further includes a medical tool that includes an inflatable balloon that can be coupled to the sheath. The inflatable balloon may include a distal end and a proximal end that define a longitudinal axis. At least one sensor is configured to sense at least one characteristic of blood located within a target cavity, and the at least one processor is configured to process blood characteristic data obtained from the at least one sensor.

[0069] According to a first exemplary embodiment, the at least one sensor may be a temperature sensor. The at least one temperature sensor may be located on one or more of the distal end of the balloon, the proximal end of the balloon, or the distal end of the catheter and the proximal end of the catheter. The at least one temperature sensor may include a first temperature sensor and a second temperature sensor, the first temperature sensor being located on the distal end of the balloon and the second temperature sensor being located on the proximal end of the balloon. The distal end of the catheter may include a snare portion that extends through the distal portion of the balloon, and the at least one temperature sensor may be located on one or more of the distal end of the balloon, the proximal end of the balloon, and the snare portion of the catheter. The distal end of the catheter may include a snare portion that extends through the distal portion of the balloon, and the at least one temperature sensor may include a first temperature sensor and a second temperature sensor, the first temperature sensor being located on the proximal end of the balloon and the second temperature sensor being located on the snare portion of the catheter.

[0070] The at least one sensor may be at least two electrodes. The at least two electrodes may be located on one or more of the distal end of the balloon and the proximal end of the balloon. The at least two electrodes may be located on one or more of the distal end of the balloon, the proximal end of the balloon, the distal end of the catheter, and the proximal end of the catheter. The distal end of the catheter may include a snare portion that extends through the distal portion of the balloon, and the at least two electrodes are located on one or more of the distal end of the balloon, the proximal end of the balloon, and the snare portion of the catheter. The distal end of the catheter may include a snare portion that extends through the distal portion of the balloon, and the at least one sensor may include a first electrode and a second electrode, the first electrode being located on one of the distal end of the balloon, the proximal end of the balloon, or the snare portion of the catheter, and the second electrode being a reference electrode.

[0071] The at least one sensor may be a pH sensor.

[0072] The processor may be further configured to record measurements of the at least one characteristic of the blood over time. The system may further include a memory configured to store measurements of the at least one characteristic of the blood over time. The system may further include a display configured to display the baseline characteristics of the blood next to or above the at least one characteristic of the blood over time.

[0073] The processor may be further configured to determine whether there is a blockage by comparing at least one blood characteristic data over time with the baseline of the at least one characteristic of the blood. Additionally or alternatively, the processor may be further configured to determine whether there is a blockage in the target cavity based on how quickly the at least one characteristic of the blood returns to its original value after injecting fluid.

[0074] According to the method of the first exemplary embodiment, a medical tool coupled to a distal portion of a distal end of a catheter can be positioned at a target location within a portion of a patient's organ. The method can include inflating an inflatable balloon when the balloon is positioned at the target location, injecting a fluid through an internal lumen of a delivery catheter, and detecting at least one characteristic of blood in a target cavity via the at least one sensor, processing the at least one characteristic of the blood via a processor, wherein the presence or absence of a blockage is determined by the at least one characteristic of the blood.

[0075] The target cavity is one of a pulmonary vein or a left atrium. The injected fluid can be a coolant, such as saline or glucose at a low temperature. The at least one sensor can be a temperature sensor, and the at least one characteristic of the blood is temperature. The at least one sensor can be a first electrode and a second electrode, and the at least one characteristic is bipolar electrical impedance. The at least one sensor can be a first electrode and a second electrode, the second electrode being a reference electrode, and at least one blood measurement is unipolar electrical impedance. The at least one sensor can be a pH sensor, and the at least one characteristic of the blood can be pH.

[0076] The baseline pressure of the at least one characteristic of the blood can be determined by: positioning the medical tool at a target location within a portion of a patient's organ, inflating the inflatable balloon when the balloon is positioned at the target location, injecting a fluid through the internal lumen of the delivery catheter into the target cavity in the absence of a blockage, and detecting at least one characteristic of the blood in the target cavity via the at least one sensor, and processing the at least one characteristic of the blood data via a processor and establishing the data as a baseline measurement.

[0077] The method can further include recording, via the processor, the at least one characteristic of the blood over time. The method can further include storing the measurements of the at least one blood characteristic over time in a memory. The presence or absence of a blockage can be determined by comparing the baseline of the at least one baseline blood measurement with the at least one blood measurement detected over time by the at least one sensor. The method can further include determining, via the processor, the presence or absence of a blockage by comparing the baseline of the at least one characteristic of the blood with the at least one characteristic of the detected blood over time. Additionally or alternatively, the processor can be further configured to determine whether there is a blockage in the target cavity based on how quickly the at least one characteristic of the blood returns to its original value after injecting the fluid.

[0078] The present invention discloses systems and methods for detecting blockages within the pulmonary veins, within the left atrial appendage, or within other cardiac chambers or other regions of the human body. The blockage to be detected may be the result of positioning a medical tool within a cardiac chamber for the purpose of achieving the blockage, or may be the result of a coronary artery blockage or a brain clot. Methods are disclosed wherein a coolant (e.g., saline or glucose maintained at a low temperature) is injected while a balloon catheter is positioned within the pulmonary vein orifice, and a temperature sensor is used to monitor temperature changes within the pulmonary vein or other chamber to identify whether a blockage has been achieved or detected, the temperature sensor being located at a distal or proximal position on the balloon and / or on a diagnostic guidewire (e.g., a snare) extending from the balloon. Instead of a coolant, any fluid that alters the properties of blood may be used. For example, instead of temperature, the impedance, pH, or chemical composition of the blood may be measured. Alternatively or additionally, any two electrodes located on the distal portion and / or proximal portion of the balloon and / or on a diagnostic guidewire (e.g., a snare) may be used to measure impedance (bipolar or unipolar). Alternatively or additionally, a pH sensor or some other sensor for detecting changes in the chemical composition of the blood may be used to measure changes in these blood properties. Methods are also disclosed for injecting a coolant without causing a blockage in order to measure a baseline for a particular patient at a relevant anatomical location (e.g., within the pulmonary vein), and then using that baseline as a reference for full / partial blockage identification. Methods are also disclosed for displaying the baseline and current thermodilution side by side or one after the other so that a physician can determine whether a blockage is present. Methods are also disclosed for automatically comparing the baseline and current thermodilution to identify a blockage. Methods are also disclosed for automatically identifying a blockage by analyzing the dilution pattern of temperature (without any baseline). If the temperature steadily increases, a blockage may be assumed. If the temperature increases in a wave synchronized with the heartbeat, a blockage may not necessarily be assumed. Figure 1 is a schematic illustration of an invasive medical procedure using the device 12 according to a first exemplary embodiment. The procedure is performed by a medical professional 14, and by way of example, it is assumed that the procedure in the following description includes ablating a portion of the myocardium 16 of the heart of a human patient 18. However, it should be understood that the embodiments disclosed herein are not limited to this particular procedure and may include substantially any procedure for biological tissue or non-biological materials.

[0079] To perform the ablation, the medical professional 14 inserts the probe 20 into a sheath 21 that has been pre-positioned within the patient's body cavity. The sheath 21 may include a tube defined by a sheath wall that extends a length in the proximal-distal direction. The sheath 21 is positioned such that the distal end 22 of the probe 20 enters the patient's heart. Hereinafter, reference is made to Figure 2 a medical tool 24, described in more detail below, is deployed through the lumen 17 of the probe 20 and exits from the distal end of the probe 20.

[0080] As Figure 1 shown, the device 12 is controlled by a processing device 46, which is located in the operation console 15 of the device. The device console 15 may include controls 49 used by a professional 14 to communicate with the processing device 46. During this procedure, the processing device 46 generally uses any method known in the art to track the position and orientation of the distal end 22 of the probe 20. For example, the processing device 46 may use a magnetic tracking method, in which magnetic transmitters 25X, 25Y, and 25Z external to the patient 18 generate signals in coils located in the distal end of the probe 20. A system (purchased from Biosense Webster, Inc. of Irvine, California) uses such a tracking method.

[0081] The software for the processing device 46 can be downloaded electronically to the processing device 46, for example, via a network. Additionally or alternatively, the software can be provided on a non-transitory tangible medium such as an optical, magnetic, or electronic storage medium. The tracking of the distal end 22 can be displayed on a three-dimensional representation 60 of the heart of the patient 18 on the display device 62. However, it can be displayed in a two-dimensional manner, for example, by fluoroscopy or MRI.

[0082] To operate the device 12, the processing device 46 communicates with a memory 50 that has a plurality of modules used by the processor to operate the device. Thus, the memory 50 may include a temperature module 52, an ablation module 54, and an electrocardiogram (ECG) module 56, the functions of which are described below. The memory 50 may generally include other modules, such as a force module for measuring the force on the distal end 22, a tracking module for operating the tracking method used by the processing device 46, and a perfusion module that allows the processor to control the perfusion provided to the distal end 22. For the sake of brevity, Figure 1Such other modules are not shown. The module can include both hardware elements and software elements. For example, module 54 can include a radio frequency generator having at least one output or output channel (e.g., ten outputs or ten output channels). Each of the outputs can be individually and selectively activated or deactivated by a switch. That is, each switch can be disposed between the signal generator and the corresponding output. Thus, a generator having ten outputs will include ten switches. These outputs can each be individually coupled to electrodes on the ablation catheter, such as ten electrodes 33 on the balloon 80, as described in further detail below. Such electrical connection can be achieved by establishing a circuit path between each output and each electrode. For example, each output can be connected to the corresponding electrode by one or more wires or suitable electrical connectors. Thus, in some embodiments, the circuit path can include at least one wire. In some embodiments, the circuit path can further include an electrical connector and at least a second wire. Thus, the electrodes 33 can be selectively activated and deactivated with the switches to receive radio frequency energy independently of each of the other electrodes. As Figure 5 Best shown, a sensor 23 can be positioned at the center of each electrode 33 for sensing parameters such as temperature, impedance, and / or pH. It should be understood that the center of the electrode 33 is merely an exemplary location, and the sensor 23 can be located at any position on the surface of the electrode 33. For example, the sensor 23 can be a thermocouple for sensing temperature. The memory 50 can also include a storage device 55 for storing data. The memory 50 can include any volatile and / or non-volatile memory, such as random access memory or a hard disk drive.

[0083] Figure 3 is a schematic perspective view of an inflatable medical tool 24 in the form of a balloon 80 in an inflated configuration. The medical tool 24 is for ablating an orifice 11 of a lumen such as the pulmonary vein 13, as Figure 4 shown, and the medical tool 24 is supported by a tubular shaft 70 having a proximal shaft portion 82 and a distal shaft end 88. The shaft 70 includes a hollow central tube 74 that permits a delivery catheter 72 to pass therethrough and past the distal shaft end 88. The delivery catheter 72 can be a lesion linear catheter 99 (shown in dashed lines in Figure 3 ) or a snare catheter 72, as Figure 3 shown in solid lines in. The snare catheter 72 can be inserted into the pulmonary vein 13 to correctly position the medical tool 24 relative to the orifice 11 ( Figure 4 ) prior to ablation of the orifice 11 ( Figure 4 ). The distal snare portion 72a of the catheter 72 is typically formed of a shape memory retaining material such as nitinol. It should be understood that the medical tool 24 can also be used with a linear or lesion catheter 99 (as Figure 3for use in the pulmonary vein or other parts of the heart, as shown by the dashed line in []. The lesion catheter 99 may include a force sensor (not shown) at its distal end. Thus, the delivery system may include a delivery catheter that is coupled to a handle, and the medical tool 24 is operably coupled to the handle at the distal end of the delivery catheter. The delivery catheter may include an internal lumen through which a fluid (such as saline) may flow. Any catheter used with the diagnostic / therapeutic catheter may have characteristic structures and functions including, for example, pressure sensing, ablation, and diagnosis (such as manipulation and pacing).

[0084] The balloon 80 of the medical tool 24 has an outer wall or membrane 26 of a biocompatible material formed, for example, of a plastic such as polyethylene terephthalate (PET), polyurethane, or . The shaft 70 and the distal shaft end 88 define the longitudinal axis 78 of the balloon 80. The balloon 80 is deployed through the lumen 17 of the probe 20 in a collapsed configuration and may be inflated after exiting the distal end 22. The membrane 26 of the balloon 80 is formed with perfusion pores or holes 27 (shown in Figure 6 ) through which a fluid (e.g., saline) may be discharged from the interior of the balloon 80 to the outside of the balloon to cool the tissue ablation site at the nozzle 11. Although Figure 2 and Figure 4 show the fluid exiting the balloon 80 as a jet, it should be understood that the fluid may exit the balloon at any desired flow rate or pressure, including rates that cause the fluid to exude from the balloon.

[0085] The membrane 26 supports and carries the combined electrode and multi-layer flexible circuit electrode assembly 84. The "flexible circuit electrode assembly" 84 may have many different geometric configurations. As Figure 5 best shown, the flexible circuit electrode assembly 84 has a plurality of radial bases or strips 30 on which electrodes 33 are disposed. At the center of each electrode 33, a sensor 23 may be positioned. The bases 30 are evenly distributed around the distal end 88 and the balloon 80. Each base 30 has a wider proximal portion that gradually tapers to a narrower distal portion. Alternatively or additionally, as Figure 5A shown, the bases 30 of the flexible circuit electrode assembly 84 may include radiopaque markers (e.g., 602, 604, 606), which will be described in more detail below. In Figure 5A , for clarity, the electrodes 33 and Figure 5A other details shown in [] are hidden.

[0086] Refer to Figure 3 , Figure 5 and Figure 5A, each substrate 30 has a proximal tail 31P and a distal tail 31D. The proximal tail 31P is tucked under and fastened to the medical tool 24 by a proximal ring 28P mounted on the proximal shaft portion 82 of the shaft 70. The distal tail 31D is tucked under and fastened to the medical tool 24 by a distal ring (not shown). Either or both of the tails 31D and 31P may be further covered by corresponding hemispherical caps such as the distal cap 28D. One or more electrodes 33 on each substrate make galvanic contact with the nozzle 11 during the ablation procedure, during which current flows from the electrodes 33 to the nozzle 11, as Figure 4 shown.

[0087] For simplicity, the flexible circuit electrode assembly 84 ( Figure 3 ) is described with respect to only one of the substrates 30, as Figure 6 shown, but it should be understood that the following description can apply to each substrate 30 of the assembly 84. Now referring to Figure 6 , the flexible circuit electrode assembly 84 includes a flexible and elastic sheet substrate 34 constructed of a suitable biocompatible material (e.g., polyimide). The sheet substrate 34 may have a higher heat resistance (or higher melting temperature) compared to the balloon membrane 26. Alternatively or additionally, the substrate 34 may be constructed of a thermosetting material having a decomposition temperature that is about 100 °C or higher than the melting temperature of the balloon membrane 26.

[0088] The substrate 34 is formed with one or more perfusion pores or holes 35 that are aligned with the perfusion holes 27 of the balloon member 26 such that fluid passing through the perfusion holes 27 and 35 can be delivered to the ablation site on the nozzle.

[0089] The substrate 34 has a first or outer surface 36 remote from the balloon membrane 26 and a second or inner surface 37 facing the balloon membrane 26. On its outer surface 36, the substrate 34 supports and carries a contact electrode 33 adapted to make tissue contact with the orifice 11. On its inner surface 37, the substrate 34 supports and carries a wiring electrode 38. The contact electrode 33 delivers RF energy to the orifice 11 during ablation or is connected to a thermocouple junction for temperature sensing of the orifice 11. In the first exemplary embodiment shown, the contact electrode 33 has a longitudinally elongated portion 40 and a plurality of thin transverse straight portions or fingers 41 that extend perpendicularly from each side of the elongated portion 40 generally between an enlarged proximal end 42P and a distal end 42D and are spaced apart generally uniformly therebetween. The elongated portion 40 has a greater width and each finger has a generally equal smaller width. Thus, the configuration or trace of the contact electrode 33 may resemble a "fishbone", but it should be noted that the present invention is not limited to such a configuration. As opposed to an area or "patch" ablation electrode, the fingers 41 of the contact electrode 33 advantageously increase the circumferential or equatorial contact surface of the contact electrode 33 with the orifice 11, while the void areas 43 between adjacent fingers 41 advantageously allow the balloon 80 to collapse inwardly or expand radially at positions along its equator as needed. In the first exemplary embodiment shown, the fingers 41 have different lengths, some longer and some shorter. For example, the plurality of fingers 41 includes distal fingers, proximal fingers, and fingers therebetween, where each of the fingers therebetween 41 has shorter adjacent fingers. For example, each finger 41 has a length different from that of its immediately distal or proximal adjacent finger 41 such that the length of each finger generally follows the tapered configuration of each substrate 30.

[0090] In the first exemplary embodiment shown, there are 22 fingers extending across the elongated portion 40 (across each of its sides), and the longest finger is the third finger from the enlarged proximal end 42P. The contact electrode 33 may include gold 58B having a seed layer therebetween the gold 58B and the membrane 26. The seed layer may include titanium, tungsten, palladium, silver, or a combination thereof.

[0091] One or more discharge zones 47 are formed within the contact electrode 33, each discharge zone surrounding a perfusion hole 35 formed in the substrate 34. The discharge zones 47 are voids intentionally formed in the contact electrode 33, as further detailed below, to avoid damage to the position and function of the contact electrode 33 when accommodating the perfusion holes 35 during construction of the electrode assembly 84.

[0092] One or more conductive blind vias 48 are also formed in the contact electrode 33. These blind vias are conductive formations or metal-containing formations that extend through the vias in the substrate 34 and are configured as cables that connect the contact electrode 33 on the outer surface 36 and the wiring electrode 38 on the inner surface 37. It should be understood that in all relevant cases, "conductive" can be used interchangeably with "metal-containing" herein.

[0093] In the first exemplary embodiment shown, the longitudinal measurement of the contact electrode 33 is between about 0.1 inches and 1.0 inches, and preferably between about 0.5 inches and 0.7 inches, and more preferably about 0.57 inches, and has four discharge zones 47 and nine blind vias 48.

[0094] On the inner surface 37 of the substrate 34, the wiring electrode 38 is generally configured as an elongated body that is generally similar in shape and size to the elongated portion 40 of the contact electrode 33. The wiring electrode 38 loosely resembles a "ridge" and also functions as a ridge in providing a predetermined degree of longitudinal stiffness to each substrate 30 of the electrode assembly 84. The wiring electrode 38 is positioned such that each blind via 48 is in conductive contact with both the contact electrode 33 and the wiring electrode 38. In the first exemplary embodiment shown, the two electrodes 33 and 38 are longitudinally aligned with other electrodes, and all nine blind vias 48 are in conductive contact with the two electrodes 33 and 38. The wiring electrode 38 may have an inner portion of copper 57 and an outer portion of gold 58.

[0095] The wiring electrode 38 also forms a discharge zone 59 around the perfusion hole 35 in the substrate 34. The wiring electrode 38 also forms a pad portion 61, at least one active pad portion 61A, and one or more inactive pad portions 61B may be present. The pad portions 61A and 61B are extensions of the side of the elongated body of the wiring electrode 38. In the first exemplary embodiment shown, the active pad portion 61A is formed at approximately the middle position along the elongated body, and corresponding inactive pad portions 61B are provided at each of the enlarged distal end 42D and the enlarged proximal end 42P.

[0096] A pair of wires (such as constantan wire 51 and copper wire 53) is attached to the active pad portion 61A, for example, by soldering 63. The copper wire 53 provides a lead to the wiring electrode 33, and the copper wire 53 and the constantan wire 51 provide a thermocouple with the joint at the soldering 63. The pair of wires 51 / 53 passes through the via 29 formed in the film 26. It should be understood that in other embodiments, in the absence of the via 29, the pair of wires 51 / 53 may extend between the film 26 and the substrate 34 and also extend proximally between the film 26 and the proximal tail 31P until the pair of wires 51 / 53 enters the tubular shaft 70 via another via (not shown) formed in the side wall of the tubular shaft closer to the proximal ring 28.

[0097] A flexible circuit electrode assembly 84 including a substrate 30 and tails 31P and 31D is attached to the balloon membrane 26 such that the outer surface 36 of the substrate 34 is exposed and the inner surface 37 of the substrate 34 is attached to the balloon membrane 26, wherein the wiring electrode 38 and the wire pairs 51 / 53 are sandwiched between the substrate 34 and the balloon membrane 26. The perfusion holes 35 in the substrate 34 are aligned with the perfusion holes 27 on the balloon membrane 26. The discharge regions 59 in the wiring electrode 38 and the discharge regions 47 in the contact electrode 33 are concentrically aligned with each other and are respectively concentrically aligned with the perfusion holes 27 and 35 in the balloon 26 and the substrate 34.

[0098] Reference Figure 7 and Figure 8 , for occlusion detection, the system 700 may include a sheath 102, a delivery system 19, a medical tool 24 (including the balloon 80 and the processing device 46 as described above), and at least one sensor 23. The system may also include a memory 50 and a display device 62 as described above. The processing device 46, the memory 50, and the display device 62 may be part of an operating console 15. The system may optionally include additional sensors 23 located throughout the system 700, as described below. The operating console 15 may also include an I / O interface.

[0099] The at least one sensor 23 may be configured to detect at least one physical property of the blood. As an example, the at least one sensor 23 may be a temperature sensor 23, such as a thermocouple. Now refer to Figure 3 , Figure 4 and Figure 8 , according to a first exemplary embodiment, the at least one temperature sensor 23 may be located on one or more of the distal end of the balloon 80, the proximal end of the balloon 80, the distal end of the catheter 72, and the proximal end of the catheter 72, or at the center of each electrode 33. The at least one temperature sensor 23 may include a first temperature sensor 23 and a second temperature sensor 23, the first temperature sensor 23 being located on the distal end of the balloon 80 and the second temperature sensor 23 being located on the proximal end of the balloon 80. The distal end of the catheter 72 may include a snare portion 72a that extends through the distal portion of the balloon 80, as described above, and the at least one temperature sensor 23 may be located on one or more of the distal end of the balloon 80, the proximal end of the balloon 80, and the snare portion 72a of the catheter 72. The distal end of the catheter 72 may include a snare portion 72a that extends through the distal portion of the balloon 80, as described above, and the at least one temperature sensor 23 may include a first temperature sensor 23 and a second temperature sensor 23, the first temperature sensor 23 being located on the proximal end of the balloon 80 and the second temperature sensor 23 being located on the snare portion 72a of the catheter 72, as Figure 8As shown. Alternatively or additionally, according to the first exemplary embodiment, the at least one sensor 23 may be at least two electrodes. The at least two electrodes may be located on one or more of the distal end and the proximal end of the balloon 80. Alternatively or additionally, the at least two electrodes may be located on one or more of the distal end of the balloon 80, the proximal end of the balloon 80, the distal end of the catheter 72a, and the proximal end of the catheter 72. The distal end of the catheter 72 may include a snare portion 72a that extends through the distal portion of the balloon 80, and the at least two electrodes may be located on one or more of the distal end of the balloon 80, the proximal end of the balloon 80, and the snare portion 72a of the catheter 72. Alternatively or additionally, the distal end of the catheter 72 may include a snare portion 72a that extends through the distal portion of the balloon 80, and the at least one sensor 23 may include a first electrode and a second electrode, the first electrode being located on one of the distal end of the balloon 80, the proximal end of the balloon 80, or the snare portion 72a of the catheter 72, and the second electrode being a reference electrode.

[0100] Alternatively or additionally, the at least one sensor 23 may be a pH sensor.

[0101] The processing device 46 may be further configured to record measurements of the at least one characteristic of the blood over time. The system 700 may further include a memory 50 configured to store measurements of the at least one characteristic of the blood.

[0102] Now referring to Figure 8A , the display device 62 may be configured to display the at least one characteristic of the blood over time. The display device 62 may display the at least one characteristic of the blood over time in a meaningful manner (such as a chart or graph), as Figure 8A shown. The display device 62 may be further configured to display the baseline characteristics of the blood next to or above the at least one characteristic of the blood over time. In Figure 8A , two graphs are shown, showing the results of an experiment using a model simulating the pulmonary vein. In each graph, temperature is plotted against time. The model includes a heater, a circulator, and two pulmonary veins for heating water to a baseline temperature (e.g., about 37 °C), and the model provides the ability to control the flow rate of water through the model pulmonary veins to simulate blood flow through human pulmonary veins. In one of the models labeled "Baseline (no obstruction)" represented by the leftmost graph in Figure 8A , the PV remains unobstructed, while in the one represented by Figure 8AIn another model labeled "Occlusion Intent" represented by the rightmost curve graph, PV is represented as being completely occluded by the medical tool 24 placed therein. Both curve graphs show the temperature change over time with the introduction of a coolant such as normal saline. In both cases (no occlusion and complete occlusion), the coolant is injected through the inner lumen of the delivery catheter and into the model pulmonary vein through the hub of the medical tool 24, while the temperature change therein is monitored using the temperature sensor 23 located on the distal portion of the balloon 80 and / or on the distal portion of the catheter (such as the snare 72a). The left curve graph shows that in the absence of any occlusion, when the coolant is injected into the model cavity, the blood temperature rapidly drops from the steady-state baseline temperature of about 37°C to about 27.5°C, and then rapidly approaches or returns to the baseline temperature due to the rapid flushing of the coolant from the model PV in the absence of occlusion. In contrast, in the right curve graph, in the presence of complete occlusion, when the coolant is injected, the temperature rapidly drops from the baseline to a significantly lower temperature (about 23°C) and returns to the steady-state baseline temperature over a longer period of time. It should be understood that normal saline is an exemplary coolant, and other suitable coolants can be employed in this application in the human pulmonary vein. As an alternative to the coolant, a fluid material having a pH or impedance different from that of blood can replace the coolant and its measurement is used to determine the presence or absence of occlusion. For example, instead of temperature, the impedance of normal saline, which has a lower impedance than blood, can be measured. Thus, the presence or absence of occlusion can be determined based on the profile of the curve. The processing device 46 can be further configured to monitor at least one blood characteristic curve to understand the effect of the heartbeat that may be related to the occlusion level.

[0103] Now referring to Figure 8B , a summary of the experimental results is shown in this figure, where the medical tool 24 of the first exemplary embodiment is inserted into the superior vena cava to create no occlusion, partial occlusion, and complete occlusion conditions in the cavity. The sensor 23 (e.g., thermocouple) is placed on the distal end of the balloon 80 and / or on the loop of the snare 72a, but can be placed anywhere in the cavity to detect temperature changes. The curve graph summarizes the results of the experiments conducted under no occlusion, partial occlusion, and complete occlusion conditions in the cavity. For example, normal saline is introduced into the cavity as a coolant, first through the perfusion pores 27 ( Figure 6 ) of the balloon 80 during inflation of the balloon in the cavity, and then a predetermined amount of normal saline, such as 10 or 20 ml, is injected through the hub of the medical tool 24 over a predetermined period of time, such as within a 4-second period.

[0104] As Figure 8BAs shown in the graph, the experimental results indicate that, in the absence of blockage, when the coolant as described above is introduced into the cavity, there is a slight deviation, but it almost immediately returns to the baseline or steady-state temperature of approximately 37°C. Compared with the results without blockage, when the medical tool 24 is placed to create a partial blockage within the cavity, when the same coolant is introduced in the above-described manner, the temperature rapidly drops from the baseline to a lower temperature, i.e., approximately 24°C, and it takes a longer period of time to return to the baseline temperature of approximately 37°C. Finally, when compared with the results of no blockage and partial blockage, when the medical tool 24 is placed within the cavity to create a complete blockage, when the same coolant is introduced in the above-described manner, the temperature rapidly drops from the baseline to an even lower temperature, i.e., approximately 22°C, and it includes a longer recovery period to return to the steady-state or baseline temperature. Using such temperature / time profiles or curves, the presence and sufficiency of blockage can be determined.

[0105] Now referring to Figure 8C and Figure 8D , experiments were conducted in which the balloon 80 was inserted into the appropriate position within the opening 11 of the superior vena cava to create a partial blockage to include a blocked area and a leakage area indicated by arrow 81 ( Figure 8C ). In this blocked area, the balloon 80 touches the inner wall of the cavity, and in this leakage area, blood can flow past the balloon 80. The temperature sensors 23 are located at the center of each electrode 33 positioned above the circumference of the balloon 80 ( Figure 3 and Figure 5 ). Thus, most of the sensors 23 are positioned to touch the cavity wall in the blocked area, and one or two sensors 23 are positioned away from the cavity wall in the leakage area. By positioning the sensors 23 in this way, temperature changes in the leakage area and the blocked area can be detected and compared. As Figure 8D shows, line 86 indicates the temperature sensed in the blood leakage area. In contrast, line 90 indicates the temperature sensed in the blocked area. When the coolant, such as normal saline (at a rate of 35 ml / min), is introduced into the cavity through the perfusion pores 27 during the inflation of the balloon 80, a more rapid temperature drop is detected in the blocked area 90 than in the leakage area 86. Additionally, when the coolant is introduced by injection (indicated as "coolant injection 20 cc"), the rate of temperature drop in the leakage area 86 increases. As Figure 8D shows, when the coolant injection is completed, the temperature recovery in the leakage area 86 is different from that in the blocked area 90. When the blockage or "release of blockage" is removed from the cavity, the temperature in both areas eventually returns to the baseline temperature, as indicated at lines 86 and 90. Alternatively or additionally, during the inflation of the balloon, the coolant can be introduced into the cavity only through the perfusion pores 27 without any injection through the hub of the medical tool 24.

[0106] Alternatively or additionally, the processing device 46 may be further configured to determine whether a blockage exists by comparing at least one blood characteristic data over time with a baseline of the at least one characteristic of the blood. The processing device 46 may be configured to perform an algorithm based on the at least one blood characteristic to determine the presence or absence of a blockage, or to calculate a figure indicative of the degree of blockage. The at least one blood characteristic may be any physical or chemical characteristic of the blood, the physical or chemical characteristic being measured prior to the procedure to establish a baseline such that any change over time exceeding a predetermined threshold after balloon inflation can be used to infer that a blockage is occurring or being achieved.

[0107] Reference Figure 9 , a method for blockage detection is disclosed. The method may be performed using the system for blockage detection disclosed above. At step 901, the medical tool 24 is positioned at a target location within a portion of a patient's organ such that a blockage will be established. The medical tool 24 is positioned via a delivery catheter 72. The delivery catheter 72 may be a lesion linear catheter 99 or a snare catheter 72a. The medical tool 24 is coupled to a distal portion of the distal end of the delivery catheter 72, as discussed above. The medical tool 24 may include an inflatable balloon 80 and at least one sensor 23, as described above. At step 902, when the balloon 80 is positioned at the target location, the inflatable balloon 80 is inflated. The inflatable balloon 80 has a distal end and a proximal end defining a longitudinal axis 78, as described above. At step 903, fluid is injected into the target cavity through the inner lumen of the delivery catheter 72. Additionally or alternatively, the inflatable balloon 80 may include perfusion pores 27, as described above, and fluid may be injected into the target cavity through the delivery catheter 72 and through one or more of the perfusion pores 27 of the inflatable balloon 80. The target cavity may be one of the pulmonary veins or the left atrium of the heart. The fluid may be a coolant, such as saline or glucose at a low temperature. At step 904, the at least one characteristic of the blood is detected via the at least one sensor 23. At step 905, the processing device 46 processes the at least one characteristic of the blood. The presence or absence of a blockage is determined by the at least one characteristic of the blood. Injecting a fluid such as saline may change the at least one characteristic of the blood within the target cavity. Accordingly, a change in the at least one characteristic of the blood may indicate the presence or absence of a blockage.

[0108] The at least one sensor 23 can be a temperature sensor, and the at least one characteristic of the blood can be temperature. Alternatively or additionally, the at least one sensor 23 can be a first electrode and a second electrode, and the at least one characteristic can be bipolar electrical impedance. Alternatively or additionally, the at least one sensor 23 can be a first electrode and a second electrode, the second electrode being a reference electrode, and the at least one blood measurement can be monopolar electrical impedance. Alternatively or additionally, the at least one sensor 23 can be a pH sensor, and the at least one characteristic of the blood can be pH.

[0109] Reference Figure 10 , a baseline pressure of the at least one characteristic of the blood can be determined. At step 1002, the medical tool 24 can be positioned at a target location within a portion of the patient's organ such that no blockage is established. At step 1002, when the balloon 80 is positioned at the target location, the inflatable balloon 80 can be inflated. At step 1003, a fluid is injected through the inner lumen of the delivery catheter. Additionally or alternatively, the inflatable balloon 80 can include perfusion pores 27, as described above, and the fluid can be injected into the target cavity through the delivery catheter 72 and through one or more of the perfusion pores 27 of the inflatable balloon 80. At step 1004, at least one characteristic of the blood in the target cavity is detected via the at least one sensor 23. At step 1005, the processing device 46 processes the at least one characteristic of the blood data and establishes the data as a baseline measurement.

[0110] The method can further include recording, via the processing device 46, the at least one characteristic of the blood over time. The method can further include storing, in the memory 50, the measurements of the at least one blood characteristic over time. The presence or absence of a blockage can be determined by comparing the baseline of the at least one baseline blood measurement with the at least one blood measurement over time detected by the at least one sensor 23. The method can further include determining, via the processing device 46, the presence or absence of a blockage by comparing the baseline of the at least one characteristic of the blood with the at least one characteristic of the detected blood over time. Additionally or alternatively, the processing device 46 can be further configured to determine whether there is a blockage in the target cavity based on how quickly the at least one characteristic of the blood returns to its original value after the injection of the fluid. The method can further include executing, via the processing device 46, an algorithm to detect the presence or absence of a blockage or to calculate a number indicative of the degree of blockage. The method can further include monitoring, via the processing device 46, the curve of the at least one characteristic of the blood over time to understand the effect of the heartbeat that can be related to the level of blockage.

[0111] Regarding Figure 9 and Figure 10The methods described and shown are also algorithms that skilled software engineers can use to generate the necessary step-by-step computer code to implement the entire method in a computer system (e.g., a general-purpose computer or a special-purpose computer, such as the Carto system), such that the embodiments described herein can be used to detect blockages.

[0112] According to a second exemplary embodiment, a medical tool system for detecting blockages in the left atrial appendage ("LAA") of the heart is provided.

[0113] A method for detecting blockages according to the present disclosure includes positioning a medical tool coupled to the distal end of a delivery catheter at a target location within a portion of a patient's organ, the medical tool including an occluder portion, an anchor portion, a tissue growth member, and a hub; deploying the occluder portion of the medical tool and, when the occluder portion is in an expanded deployed position, actuating the anchor portion from a retracted position to an anchor deployed position; injecting a fluid through the delivery catheter and into the target cavity through the hub of the medical tool, wherein the tissue growth member prevents the fluid from leaving the cavity; detecting at least one characteristic of the blood in the target cavity via at least one sensor; and processing the at least one characteristic of the blood data via a processor, wherein the presence or absence of a blockage is determined by the at least one characteristic of the blood.

[0114] According to a second exemplary embodiment, the fluid may include a coolant, such as saline. Additionally or alternatively, the fluid may include glucose at a low temperature.

[0115] The at least one sensor may include a temperature sensor, and the at least one characteristic includes temperature. Alternatively or additionally, the at least one sensor includes a first electrode and a second electrode, and the at least one characteristic may include bipolar electrical impedance. Alternatively or additionally, the at least one sensor may include a first electrode and a second electrode, and the second electrode may be a reference electrode, and the at least one characteristic may include monopolar electrical impedance. Alternatively or additionally, the at least one sensor may include a pH sensor, and the at least one characteristic may include pH.

[0116] Alternatively or additionally, according to a second exemplary embodiment, the method may further include determining a baseline of the at least one characteristic of the blood by: positioning a medical tool at a target location within a portion of an organ of a patient such that no occlusion is established; deploying a occluder portion of the medical tool, and when the occluder portion is in an expanded deployed position, actuating an anchor portion having barbs from a retracted position to an anchor deployed position without establishing a complete occlusion; injecting a fluid through a delivery catheter and into the target cavity through a hub of the medical tool; detecting at least one characteristic of the blood in the target cavity via the at least one sensor; and processing the at least one characteristic of the blood data via a processor and establishing the data as a baseline measurement.

[0117] The method of the second exemplary embodiment may further include recording, via a processor, measurements of the at least one characteristic of the blood over time. The method may further include storing the measurements of the at least one characteristic of the blood over time in a memory.

[0118] According to the second exemplary embodiment, the presence or absence of an occlusion is determined by comparing the baseline measurement with at least one characteristic of the detected blood over time. The method may further include determining, via a processor, the presence or absence of an occlusion by comparing the baseline measurement with at least one characteristic of the detected blood over time.

[0119] According to the second exemplary embodiment, the target cavity may be the LAA, and the barbs of the anchor portion may be configured to engage tissue with the LAA. The processor may be further configured to determine whether there is an occlusion in the LAA based on how quickly the at least one characteristic of the blood returns to its original value after injecting the fluid.

[0120] According to the second exemplary embodiment, the barbs of the anchor portion may be configured to engage tissue with the LAA and the left atrium. The method may be performed twice, once on the LAA and once on the left atrium. The processor may be further configured to record the at least one blood characteristic of the LAA over time and the at least one characteristic of the blood in the left atrium, and compare the at least one characteristic of the blood in the LAA with the at least one characteristic of the blood in the left atrium. Alternatively or additionally, the processor may be further configured to use the comparison of the at least one characteristic of the blood in the LAA with the at least one characteristic of the blood in the left atrium to determine whether there is an occlusion in the LAA, and use the comparison of the at least one characteristic of the blood in the LAA with the at least one characteristic of the blood in the left atrium to determine whether there is an occlusion in the left atrium.

[0121] A system for occlusion detection according to the present disclosure includes a sheath, a delivery system, a medical tool, at least one sensor, and a processor. The sheath has a length and a sheath lumen extending through the length of the sheath. The delivery system includes a delivery catheter extending between a proximal end and a distal end, and a handle coupled to the proximal end of the delivery catheter. The medical tool is coupled to the distal end of the delivery catheter at a target location within a portion of a patient's organ. The medical tool includes a hub that includes a bore defining an axis; an occluder portion coupled to the hub, the occluder portion being configured to be moved to an occluder non-deployed position, wherein the occluder portion is within a distal portion of the sheath; and the occluder portion being configured to be moved to an occluder deployed position when the sheath is moved proximally relative to the occluder portion; and an anchor portion extending between a first end and a second end, the anchor portion having barbs configured to engage tissue, the first end being coupled to the handle, and the second end being pivotally coupled to a distal end portion of the occluder portion, wherein the anchor portion is capable of pivoting relative to the occluder portion between an anchor non-deployed position and an anchor deployed position when the occluder portion maintains the occluder deployed position. The at least one sensor is configured to detect at least one physical property of blood. The at least one processor is configured to process blood property data obtained from the at least one sensor.

[0122] In a second exemplary embodiment, the at least one sensor may include a temperature sensor. The at least one sensor may include at least two electrodes. One electrode may include a reference electrode. Alternatively or additionally, the at least one sensor may include a pH sensor.

[0123] The at least one sensor may be located on a distal portion of the sheath. Alternatively or additionally, the at least one sensor may be located on a distal end of the delivery catheter, or may be located on a proximal end of the delivery catheter.

[0124] In a second exemplary embodiment, the barbs of the anchor portion may be configured to engage tissue within the LAA. Alternatively or additionally, the barbs of the anchor portion may be configured to engage tissue within the left atrium.

[0125] In a second exemplary embodiment, the processor may be further configured to compare blood characteristic data obtained from the at least one sensor with baseline blood characteristics. Alternatively or additionally, the processor may be further configured to record measurements of the at least one characteristic of the blood over time. The system may also include a memory configured to store measurements of the at least one characteristic of the blood. The system may also include a display configured to display the at least one characteristic of the blood over time. The display may be further configured to display the baseline characteristics of the blood next to or above the at least one characteristic of the blood over time. The processor may be further configured to determine whether there is an occlusion in the LAA based on how quickly the at least one characteristic of the blood returns to its original value after fluid is detected.

[0126] According to the second exemplary embodiment, the tines of the anchor portion may be configured to engage tissue with the LAA and the left atrium. The processor may be further configured to record the at least one blood characteristic of the LAA and the at least one blood characteristic of the blood in the left atrium, and compare the at least one blood characteristic of the blood in the LAA with the at least one blood characteristic of the blood in the left atrium. Alternatively or additionally, the processor may be further configured to: use the comparison of the at least one blood characteristic of the blood in the LAA with the at least one blood characteristic of the blood in the left atrium to determine whether there is an occlusion in the LAA; and use the at least one blood characteristic of the blood in the LAA and the at least one blood characteristic of the blood in the left atrium to determine whether there is an occlusion in the left atrium.

[0127] First referring to Figure 11 and Figure 11A , a distal end portion of a medical tool 1020 and a delivery system 1022 are provided. The medical tool 1020 and the delivery system 1022 may be used in an interventional procedure to close and correct an opening or cavity (not shown) within the heart (not shown), such as the LAA, through the skin. The medical tool 1020 may include a frame member of a occluder portion 1024 and an anchor portion 1026, and the occluder portion 1024 further includes a tissue growth member 1028 attached thereto. Additionally, the anchor portion 1026 may be pivotally coupled to the occluder portion 1024 such that when the occluder portion 1024 is deployed, the anchor portion 1026 can be actuated between a deployed position and a non-deployed position (not shown) via an actuation mechanism (not shown) at the handle of the delivery system 1022. With this arrangement, the medical tool 1020 and the delivery system 1022 may provide the following functions: separating the steps of deploying the occluder portion 1024 and the anchor portion 1026, thus providing additional and enhanced functionality to the physician to properly position the medical tool 1020 within the LAA and then implant the LAA.

[0128] As described above, the occluder portion 1024 may include an occluder material or tissue growth member 1028 attached thereto. The tissue growth member 1028 may be a porous material, or other cell attachment material or substrate configured to promote endothelialization and tissue growth thereon. The tissue growth member 1028 may extend above the proximal side of the medical tool 1020, particularly above the occluder portion 1024, and may extend above a portion of the anchor portion 1026 and above the hinge coupling the anchor portion 1026 to the occluder portion 1024. Thus, due to the shape of the frame member of the occluder portion 1024, the tissue growth member 1028 may include a generally convex proximal side to form an outer surface 1040. The tissue growth member 1028 may also include an inner surface 1042 that is generally concave in shape on its distal side. According to a second exemplary embodiment, the tissue growth member 1028 may extend primarily above the outer surface of the frame member of the occluder portion 1024, and a portion of the tissue growth member 1028 extends on both the outer surface and the inner surface of the frame member of the occluder portion 1024. Alternatively or additionally, the tissue growth member 1028 may extend primarily above both the outer surface and the inner surface of the frame member of the occluder portion 1024 of the medical tool 1020. The tissue growth member 1028 may extend only above the outer surface of the frame member of the occluder portion 1024.

[0129] Relative to Figure 11A and Figure 11B, the tissue growth component 1028 may include one or more types of materials and / or layers. The tissue growth component 1028 may include a first material layer 1030 and a second material layer 1032. The first material layer 1030 may be mainly the lower or base layer of the tissue growth component 1028. The first material layer 1030 may have porous and conformable structural properties. For example, the first material layer 1030 may comprise a foam-type material such as polyurethane foam or any other suitable polymeric material such as a woven or knitted polymeric fabric. The second material layer 1032 may include one or more layers of, for example, expanded polytetrafluoroethylene (ePTFE) material. The second material layer 1032 may be attached to the outer surface of the first material layer 1030 using, for example, an adhesive. The second material layer 1032 may include a first layer 1032A, a second layer 1032B, and a third layer 1032C such that the first layer 1032A may be directly attached to the first material layer 1030, and the third layer 1032C may be the outermost layer covering the proximal side of the medical device 1020, while the second layer 1032B extends between the first layer and the third layer. The layers of the second material layer 1032 may be bonded together using an adhesive and / or a thermal bonding heating process or other suitable processes known in the art. In a specific example, the outermost layers such as the second layer 1032B and the third layer 1032C may be formed of ePTFE material having an inter-node distance (sometimes referred to as pore size) of about 70 μm to about 90 μm. The first layer 1032A adjacent to the first material layer 1030 of the second material layer 1032 may be formed of ePTFE material having a reduced inter-node distance relative to the second layer 1032B and the third layer 1032C. For example, the inter-node distance of the first layer 1032A may be about 10 μm. The first layer 1032A may be bonded or adhered to the first material layer 1030 using an adhesive material. Any other appropriately sized ePTFE layer may also be employed, such as an ePTFE layer having a maximum inter-node distance of about 250 μm. Additionally, there may be one or more additional layers, the size of such layers being similar to that of the first layer 1032A, extending above the hub end 1034 using fins 1036 (contoured in an "X" configuration), in which the delivery system 1022 is interconnected with the medical tool 1020 (see Figure 1 ).

[0130] The second material layer 1032 made of ePTFE effectively prevents blood passage because the first layer 1032A therein has a smaller inter-node distance and pore size, while the other layers (such as 1032B and 1032C) have a larger inter-node distance, thus enabling tissue in-growth and endothelialization. In addition, the first material layer 1030 formed of polyurethane foam enables tissue to actively grow from the LAA wall into the tissue growth member 1028 at the inner or concave side of the medical tool 1020. Moreover, the first material layer 1030 provides an exposed shelf 1038 on the outer surface 1040 around the perimeter and distal end portion of the tissue growth member 1028 to promote the active growth of fibroblasts and tissue, thereby further causing endothelialization above the outer surface 1040 of the second material layer 1032. It is worth noting that using an appropriate adhesive material between the first material layer 1030 and the next adjacent layer 1032A can also help fill the small holes in the next adjacent layer 1032A and further inhibit the possibility of blood flowing through the tissue growth member 1028. An additional ePTFE layer can also be added to the second material layer 1032 of the tissue growth member 1028.

[0131] Reference Figure 12 and Figure 13 , the medical tool 1020 and its frame components will be described below. Figure 12 Depicts the frame components that have been installed and are in a fully deployed state, and Figure 13Depicts a frame member cut from a flat sheet. As previously described, the medical tool 1020 includes a occluder portion 1024 and an anchor portion 1026. The occluder portion 1024 may include a plurality of occluder frame segments that may be interconnected to form the occluder portion 1024. The occluder portion 1024 may extend between a first end 1044 and a second end 1046, with a surface strut 1050 and an occluder zigzag portion 1052 therebetween. Additionally, the occluder portion 1024 includes a base extension 1048 extending from the first end 1044. The base extension 1048 may be coupled to a hub 1054 via a ring 1056, where a notch is defined at the inner diameter of the ring 1056. Each base extension 1048 may extend from the most proximal portion of the occluder portion 1024 or from the first end 1044, which is one end of each base extension 1048 and the surface strut 1050. The size and configuration of each base extension 1048 may be set to be positioned around the hub 1054 and held by one or more rings 1056. Each base extension 1048 may extend at the first end 1044 to a surface strut 1050 of the occluder portion 1054, and the surface strut 1050 extends radially distally from the first end 1044. Each surface strut 1050 may include a projection 1058 on its back surface, and the projection 1058 has a hook-like configuration sized and configured to hold a portion of a tissue growth member (not shown). Additionally, each surface strut 1050 extends to a V projection 1060 of the occluder zigzag portion 1052 such that the distal end of each V projection 1060 may be coupled to the distal end of an adjacent V projection 1060 (side by side) to define the occluder zigzag portion 1052. The occluder zigzag portion 1052 may expand radially distally from the surface strut 1050 to the distal end or the second end 1046 of the occluder portion 1024. The occluder portion 1024 may include an occluder eyelet 1062 at the second end 1046, and the size and configuration of the eyelet are set to be coupled to the anchor portion 1026 in a hinged manner.

[0132] The anchor portion 1026 may include a plurality of anchor frame segments that may be connected to each other to form the anchor portion 1026. The anchor portion 1026 may extend between a first end 1064 and a second end 1066, with an anchor actuator arm 1068 and an anchor zigzag portion 1070 therebetween. The anchor actuator arm 1068 may extend between the first end 1064 and the anchor zigzag portion 1070. Each anchor actuator arm 1068 may be configured to be coupled to a snap ring configuration or a spline sleeve 1072 at the first end 1064 of the anchor portion 1026 such that the anchor actuator arms 1068 are coupled together or as a unit via the spline sleeve 1072. The spline sleeve 1072 may be configured to be actuated along the axis 1074 of the medical tool 1020 to move the anchor portion 1026 between an anchor deployment position and an anchor non-deployment position (not shown), which will be discussed in more detail below.

[0133] Now referring to Figure 12 、 Figure 13 and Figure 13A , the anchor actuator arm 1068 may also include a bend portion 1076. The bend portion 1076 defines a taper 1082 and a radius that extend along the radial length of the bend portion 1076 toward the anchor zigzag portion 1070 and then widen again at the anchor zigzag portion 1070. This taper 1082 along the radial length in the bend portion 1076 facilitates the repeated movement of the anchor portion 1026 between the deployment position and the non-deployment position while also maintaining the structural integrity of the anchor portion 1026 and minimizing stress and strain in the bend portion 1076 while favoring a compact radius or loop. In one embodiment, the anchor actuator arms 1068 may each include a coil (not shown) that may be wound around a portion of the actuator arm and over the bend portion 1076, with the ends of the coil fixed to the anchor actuator arm 1068. Such a coil may substantially capture the anchor actuator arm 1068 such that it cannot extend to an undesirable position in the LAA, thereby preventing breakage or fragmentation of the anchor actuator arm 1068.

[0134] Each bent portion 1076 of the anchor actuator arm 1068 may extend to an anchor V extension 1078 such that the proximal end of each anchor V extension 1078 may be coupled to the proximal end of an adjacent anchor V extension 1078 (similar to the occluder zigzag portion 1052) to form an anchor zigzag portion 1070. At the connection of the proximal end of the anchor V extension 1078 or the second end 1066 of the anchor portion 1026, such proximal ends define an anchor eyelet 1080. The size and configuration of the anchor eyelet 1080 may be set to be coupled in a hinged manner to a corresponding occluder eyelet 1062 in the occluder portion 1024, as shown by the dashed line 1084 (see Figure 13 ).

[0135] See Figure 13A , the anchor struts or anchor V extensions 1078 of the anchor zigzag portion 1070 may include one or more hooks 1086 or barbs that may extend away from the occluder portion 1024 from the anchor portion 1026 or the anchor V extension at an acute angle 1088. The range of such acute angle 1088 may be between about forty-five degrees and about sixty degrees. Additionally, the hook 1086 may extend from the anchor V extension 1078 at a predetermined height 1090 to effectively engage the tissue wall within the LAA, but not to the extent of fully piercing the tissue wall, so as not to cause LAA leakage. The hook also has a thickness 1092 (see Figure 12 ). This thickness 1092 may be similar to the thickness of the sheet of material from which the frame members (i.e., the occluder portion 1024 and the anchor portion 1026) of the medical tool 1020 are cut.

[0136] Relative to Figure 13 , the occluder portion 1024 and the anchor portion 1026 are shown in a preformed state after being laser cut from a flat sheet or sheet material (e.g., a superelastic material such as nitinol). Thus, the occluder portion 1024 and the anchor portion 1026 in the preformed state may be substantially flat planes, and then, as is known to those of ordinary skill in the art, the frame members of the occluder portion 1024 and / or the anchor portion 1026 may be heat set into the desired shape and configuration, which is similar to the fully deployed configuration (see Figure 12)。In addition, those of ordinary skill in the art also know that other processes (such as chemical etching and electrolytic polishing processes) can be used to machine the frame components. The occluder portion 1024 may include ten surface struts 1050 and ten base protrusions 1048, and ten occluder holes 1062 extend from the occluder zigzag portion 1052. Similarly, the anchor portion 1026 may include ten anchor actuator arms 1068, and ten anchor holes 1080 extend from the anchor zigzag portion 1070. It should be noted that the occluder portion 1024 and the anchor portion 1026 may include more or fewer frame components, such as the corresponding surface struts 1050 and anchor actuator arms 1068, as is known to those of ordinary skill in the art. As shown by the dashed line 1084, the occluder holes 1062 may be configured to be coupled to the corresponding anchor holes 1080 in a hinge-like coupling arrangement. By directly interlocking the occluder holes 1062 with the anchor holes 1080 (as Figure 12 shown), such a coupling arrangement can be employed.

[0137] The frame components of the occluder portion 1024 and the anchor portion 1026 can be laser cut from tubular material instead of flat sheets. The frame components can be laser cut first and then heat set into the desired configuration (similar to Figure 12 the shown configuration). It is readily understood by those of ordinary skill in the art that various frame components of the occluder portion 1024 and the anchor portion 1026 may need to be modified.

[0138] Referring Figure 13B , the occluder portion 1024 and the anchor portion 1026 can be coupled together in an articulated manner by aligning the occluder holes 1062 with the anchor holes 1080 and then passing a single interlock 1094 (shown in outline) through each of the corresponding aligned holes 1062, 1080 and positioning it within the aligned holes. Such an interlock 1094 can be a polymer filament or the like. The ends 1096 of the interlock 1094 can be heated to form a bulbous shape (not shown) at the ends 1096, which hardens and retains the bulbous shape when cooled to prevent the corresponding aligned holes from disengaging. In this way, the occluder holes 1062 and the anchor holes 1080 can be interlocked via the interlock 1094 to provide an articulated coupling arrangement of the anchor portion 1026 to pivot the anchor portion relative to the occluder portion 1024, and more specifically, to pivot the anchor portion 1026 about the occluder holes 1062. In another embodiment, the interlock 1094 can be a metal rivet that is press fit through the aligned holes to form an articulated coupling arrangement.

[0139] Now referring Figure 14, a medical tool delivery system 1100 is provided for delivering a medical tool 1020 to, for example, the LAA. The medical tool delivery system 1100 may include the aforementioned delivery system 1022, the medical tool 1020, and a sheath 1102. The delivery system 1022 may include a delivery catheter 1104 that is coupled to a handle 1106, and the medical tool 1020 is operably coupled to the handle 1106 at a distal end of the delivery catheter 1104. The delivery catheter 1104 may be sized and configured to be inserted through the sheath 1102 such that the medical tool 1020 can be advanced through the sheath 1102 to a distal end of the sheath. At least one sensor 23 may be located on the distal end of the sheath 1102. As shown, the medical tool 1020 may be partially exposed during certain stages of delivery. The functions and details of the various components of the medical tool delivery system 1100 will be described in detail below.

[0140] Now referring to Figure 15 , Figure 15A and Figure 15B , the distal portion of the delivery catheter 1104 will now be described. Figure 15A For Figure 15 is a cross-sectional view of the distal portion of the delivery catheter 1104 taken along the axis 1105 of the delivery catheter 1104 as described in Figure 15BAn enlarged cross-sectional view of a portion of the distal portion of the delivery catheter. The delivery catheter 1104 may define a lumen 1108 that longitudinally extends therethrough between a proximal end (not shown) and a distal end 1110 of the delivery catheter 1104. The delivery catheter 1104 may include a shaft (not shown), a helical cutting portion 1112, an inner distal tube 1114, and a collet 1116. The distal portion of the delivery catheter 1104 may include at least one sensor 23. Additionally or alternatively, the proximal portion of the delivery catheter 1104 may include at least one sensor 23. The distal portion of the delivery catheter 1104 may have increased lateral flexibility along a region of the helical cutting portion 1112. That is, the distal portion of the delivery catheter 1104 may be more flexible than a portion of the delivery catheter 1104 that is more proximal to the helical cutting portion 1112. As shown, the helical cutting portion 1112 may be formed by helically cutting slits in the peripheral structure of the distal portion of the delivery catheter 1104. The inner distal tube 1114 may be coupled to the delivery catheter 1104 and may be located within the lumen 1108 of the distal portion of the delivery catheter 1104. The collet 1116 may be positioned at the distal end 1110 of the delivery catheter 1104 and thermally coupled thereto, and may be located within the inner distal tube 1114, with collet fingers 1118 extending distally therefrom. The size and configuration of the collet fingers 1118 may be set to latch onto a hub (not shown) of a medical tool, with a protrusion 1120 or projection extending from the free end of the collet fingers 1118. The collet fingers 1118 are capable of moving outwardly as shown by arrow 1122 and are biased to an inward position as shown. The collet 1116 and the collet fingers 1118 may be made of a metallic material such as stainless steel or nitinol, or any other suitable metallic material that can maintain a biasing force. This inward biasing of the collet fingers 1118 will be described in further detail below. With respect to the increased flexibility of the delivery catheter 1104 along the helical cutting portion 1112, this increased flexibility facilitates the self-centering of a medical tool during deployment in the LAA. In other words, the radial strength of the medical tool (not shown) may be greater than the lateral force of the delivery catheter 1104 along the helical cutting portion 1112, allowing the medical tool to self-center within the LAA in the event that the shaft 1105 of the delivery catheter is not concentric with the ostium of the LAA during delivery and deployment of the medical tool.

[0141] Now refer to Figure 16A 、 Figure 16B and Figure 16C, the steps that can be used to load the medical tool 1020 into the sheath 1102 will be described below. For example, the delivery catheter 1104 can include a loader 1124, the size and configuration of which are set to facilitate loading the occluder portion 1024 of the medical tool 1020 into the sheath 1102, such that the delivery catheter 1104 can push the occluder portion 1024 through the sheath 1102 to the distal portion of the sheath. Refer to Figure 16A , the loader 1124 can include a tube portion 1126 and a handle portion 1128. The loader 1124 can be positioned slidably above the delivery catheter 1104 such that the delivery catheter 1104 extends through the bore defined by the loader 1124. The loader 1124 can be moved to above the distal end of the delivery catheter 1104 and manually moved or pushed above the occluder portion 1024 of the medical tool 1020 such that the occluder portion 1024 moves to a contracted position enclosed within the tube portion 1126. However, before moving the loader 1124 above the occluder portion 1024, the anchor portion should be in the non-deployed position such that the actuator knob and the plunger shaft of the handle 1106 should move to the proximal position, as Figure 18 and Figure 18A shown. Referring back to Figure 16A , when the loader 1124 is fully moved above the occluder portion 1024, the medical tool 1020 can then be advanced through the sheath 1102. At this point, the sheath 1102 has been advanced through the circulatory system into the heart, and the distal portion of the sheath 1102 is positioned in the LAA (not shown) using typical techniques known in the art.

[0142] As Figure 16B and Figure 16C shown, the loader 1124 can be inserted into the sheath 1102, and more specifically, into the sheath hub 1130. The sheath hub 1130 can be coupled to the proximal end of the sheath 1102. The components of the sheath hub 1130 can include a valve 1132 and a sheath fluid port 1134. The valve 1132 can be a rotary hemostatic valve, such as a Touhy Borst valve, etc., which is configured to constrict or limit the backflow of blood from the sheath 1102 when the valve 1132 is rotated. The sheath fluid port 1134 can extend from the sheath hub 1130, and its size and configuration can be set to purge and aspirate the air that remains trapped when the medical tool 1020 is loaded into the sheath 1102. The loader 1124 can also include a valve positioned around the delivery catheter 1104 to facilitate maintaining hemostasis when inserted into the sheath hub 1130.

[0143] As described above, the loader 1124 can be snap-fitted by snap-fastening or inserting into the sheath hub 1130, or by a click fit with a protrusion 1136 located at the distal end of the tube portion 1126 and ribs (not shown) within a bore 1138 defined in the sheath hub 1130. When the loader 1124 is positioned within the sheath hub 1130, the delivery catheter 1104 can be advanced through a longitudinally defined lumen within the sheath 1102 such that the distal end of the delivery catheter 1104 moves toward the distal portion of the sheath 1102 to expose the distal end of the occluder portion 1024 of the medical tool 1020 from the distal end of the sheath 1102. With this arrangement, the distal end of the occluder portion 1024 can be exposed at the distal end of the sheath 1102, and due to the occluder material, this distal end provides a buffer tip 1140 without exposing any metal frame members, facilitating atraumatic entry into the LAA and thus reducing the likelihood of leakage in the LAA.

[0144] Reference Figures 17 to 21 , the deployment and detachment of the medical tool 1020 within the LAA 1005 (shown in outline) relative to the delivery system 1022 will now be described. Relative to Figure 17 and Figure 18 , when the physician positions the distal portion of the sheath 1102 within the LAA 1005, the medical tool 1020 is positioned within the distal portion of the sheath 1102 and the buffer tip 1140 of the occluder portion 1024 is exposed at the distal end of the sheath 1102, allowing the physician to atraumatically position the distal portion of the sheath 1102 at the desired location within the LAA 1005. Once the desired location is determined, the physician can deploy the occluder portion 1024 of the medical tool 1020. This can be achieved by simply withdrawing the sheath 1102 or manually moving the sheath 1102 in the proximal direction. When withdrawing the sheath 1102, the occluder portion 1024 self-deploys to the occluder deployment position while the anchor portion 1026 remains in the anchor non-deployment position, as Figure 18 shown.

[0145] Relative to Figure 18, shows the distal portion of the delivery catheter 1104 coupled to the medical tool 1020. The delivery catheter 1104 of this embodiment is arranged to be coupled to the medical tool 1020 via the occluder hub nut 1142 and the collet 1116. For example, the distal portion of the delivery catheter 1104 includes an inner distal tube 1114 and an actuator shaft 1144. The actuator shaft 1144 may include a laminated coil, such as a speedometer cable, at its distal end portion, and the laminated coil may be coupled to an inner distal connector 1146 that can move within the collet 1116. As previously described, the collet 1116 may include collet fingers 1118 extending distally from the collet 1116. The inner distal connector 1146 may include threads sized and configured to couple to the occluder hub nut 1142, and more specifically, to a threaded connection hole 1148 defined in the occluder hub nut 1142. The occluder hub nut 1142 may include a splined sleeve 1072 at its distal end. As previously described, the size and configuration of the splined sleeve 1072 may be set to couple the end portions of each anchor actuator arm 1068. Alternatively or additionally, the inner distal connector 1146 and the occluder hub nut 1142 may be reversed such that the inner distal connector 1146 has a nut configuration and the occluder hub nut 1142 has a screw configuration. In either case, the medical tool 1020 can be threadedly coupled to the delivery catheter 1104.

[0146] Reference Figure 18A , depicts an embodiment of the handle 1106. The handle 1106 may include a handle housing 1150, an anchor actuator release button 1152, a plunger shaft 1154, and an actuator knob 1156. The handle housing 1150 may be coupled to the proximal portion of the delivery catheter 1104. The plunger shaft 1154 and the actuator knob 1156 are shown in a first position associated with the anchor portion 1026, where the anchor portion is in the non-deployed position (see Figure 18 ). When the anchor actuator release button 1152 is pressed, the plunger shaft 1154 and the actuator knob 1156 can move bilinearly between the first position and the second position. The function of the handle 1106 and its various components will be apparent to those of ordinary skill in the art and will be discussed in detail below.

[0147] As Figure 18 and Figure 18A shown, the anchor portion 1026 of the medical tool 1020 is in the anchor non-deployed position. Before loading the medical tool 1020 into the loader 1124, the actuator knob 1156 and the plunger shaft 1154 are moved to the first position, as indicated by the arrow 1155 corresponding to the anchor non-deployed position, and then loaded into the sheath 1102 (see Figure 16A and Figure 16B)。In the non-deployment position of the anchor, the inner distal connector 1146 can be threadedly coupled to the occluder wheel nut 1142 and positioned proximal to the wheel 1054 by the anchor portion 1026 in the first position or the non-deployment position of the anchor or the anchoring position (where a portion of the anchor actuator arm 1068 is proximal to the wheel 1054 and located within the bore 1158 defined in the wheel 1054). Additionally, in the non-deployment position of the anchor, the plunger shaft 1154 and the knob 1156 of the handle 1106 can also be in the proximal position or the first position. With this arrangement, by placing the occluder portion 1024 in the deployment position prior to deploying the anchor portion 1026, the physician can determine the most advantageous position of the medical tool 1020 within the LAA 1005.

[0148] Now refer to Figure 19 and Figure 19A, once the physician determines that the occluder portion 1024 to be deployed is positioned as needed within the LAA 1005, the anchor portion 1026 of the medical tool 1020 can be moved to the anchor deployment position or the anchor-out position or the second anchor position. This anchor deployment position can be achieved by manually moving the actuator knob 1156 distally (as indicated by arrow 1160) and simultaneously pressing the release button 1152. At the anchor deployment position, the inner distal connector 1146 and the occluder hub nut 1142 also move distally from the collet 1116 into or through the hub 1054. This linear distal movement also moves the anchor actuator arm 1068 coupled to the spline sleeve 1072 from the distal portion of the delivery catheter 1104, through and out of the hub 1054 to the everted deployment position or the open position, thereby radially opening or deploying the anchor portion 1026 by pivoting or rotating at the hinge connection (i.e., the occluder eyelet 1062 and the anchor eyelet 1080) between the occluder portion 1024 and the anchor portion 1026. At the anchor deployment position, the hooks 1086 or barbs of the anchor portion 1026 are sized and configured to grab tissue and prevent movement, thereby effectively anchoring the medical tool 1020 within the LAA 1005. Additionally or alternatively, the hooks 1086 or barbs of the anchor portion 1026 are sized and configured to grab tissue and prevent movement, thereby effectively anchoring the medical tool 1020 within the left atrium. Once the anchor portion 1026 is deployed, the physician can observe the medical tool 1020 through imaging techniques to ensure proper positioning of the medical tool 1020 within the LAA 1005 and simultaneously perform a stability test by pulling the handle 1106 proximally to ensure that the medical tool 1020 effectively engages the LAA 1005. This imaging technique can be strategically enhanced by markers located on the medical tool 1020 and the delivery catheter 1104 to provide imaging information to the physician. Such markers can be made of radiopaque materials such as platinum, gold, tantalum, or alloys thereof, or any other suitable biocompatible radiopaque material.

[0149] The hooks 1086 of the anchor portion 1026 can extend distally or proximally, thereby substantially preventing movement of the medical tool 1020 relative to the LAA 1005 in the proximal and distal directions. The hooks 1086 can include an acute angle 1088 ( Figure 13A ) with respect to the struts of the shaft 1074 of the medical tool 1020 or the anchor zigzag portion 1070. The hooks 1086 are configured to grab or pierce the tissue of the LAA 1005. The size, orientation, and configuration of such hooks 1086 are set such that they prevent the hooks 1086 from fully puncturing or piercing through the tissue of the LAA 1005, but provide an effective and even aggressive engagement with the tissue to provide secure anchoring of the medical tool 1020 within the LAA 1005.

[0150] If the physician is not satisfied with the position or engagement of the medical tool in the LAA, the physician can move the actuator knob 1156 in the proximal direction to a first position ( Figure 18A ), while moving the actuator shaft 1144 proximally, thus pivoting the anchor portion 1026 to a disengaged position or an anchor non-deployed position, and easily disengaging the anchor portion 1026 from the tissue of the LAA. The physician can then reposition the occluder portion 1024 within the LAA 1005, and once satisfied with the position of the occluder portion 1024 within the LAA 1005, the physician can easily move the actuator knob 1156 in the forward or distal direction to pivot and re-engage the anchor portion 1026 with the tissue of the LAA 1005. The physician can then re-determine whether the medical tool 1020 is positioned within the LAA 1005 in an effective and safe manner satisfactory to the physician through imaging and stability testing. It can be readily understood that the steps of repositioning the occluder portion 1024 and re-engaging the anchor portion 1026 of the medical tool 1020 can be repeated until the physician is satisfied.

[0151] Now referring to Figure 20 、 Figure 20A and Figure 20B , the function of releasing the medical tool 1020 will be described. The medical tool 1020 can be separated or released by unscrewing the inner distal connector 1146 from the screw hole 1148 defined in the occluder hub nut 1142. This release can be achieved by rotating the actuator knob 1156 of the handle 1106 counterclockwise several turns, as indicated by arrow 1162, until the inner distal connector 1146 is loosened from the screw hole 1148 of the occluder hub nut 1142. The actuator knob 1156 is then pulled back proximally to the first position, as indicated by arrow 1164, while pressing the release button 1152, which facilitates the movement of the inner distal connector 1146 in the proximal direction. As the inner distal connector 1146 moves proximally through or into the collet 1116, the collet fingers 1118 extending distally from the collet 1116 collapse inwardly since the collet fingers 1118 can be biased towards the inner position. In other words, prior to loosening the inner distal connector 1146, the collet fingers 1118 can be maintained in an outer position substantially concentric with the shaft 1074 of the medical tool 1020, which keeps the delivery catheter 1104 locked to the medical tool 1020. The collet fingers 1118 include outwardly extending protrusions 1120 that remain in contact with a base 1166 located within the hub 1054 (also shown in Figure 19)。In this way, once the inner distal connector 1146 is unscrewed from the occluder hub nut 1142 and moved to a proximal position away from the collet fingers 1118, the collet fingers 1118 flexibly collapse inwardly with a certain biasing force to move the protrusion 1120 away from the base 1166 in the hub 1054, thereby unlocking the medical tool 1020 or unlatching the delivery catheter 1104. Then, the collet fingers 1118 can be collapsed and the protrusion 1120 can be moved proximally from the base 1166 within the hub 1054 to remove the delivery catheter 1104 from the medical tool 1020, as Figure 21 shown.

[0152] See Figure 12 and Figure 22 , which depict a movable part that may include a spring 1170. The movable part may include a spring 1170 having a polymer cover in the form of a polymer flap or occluder flap 1036. The size and configuration of such a movable part with the spring 1170 can be set to be able to close the bore 1158 of the hub 1054 once the delivery catheter 1104 is released from the medical tool 1020. The spring 1170 can have a cloverleaf configuration or any other suitable configuration to effectively close the hub 1054. The spring 1170 can move between a first biased position (or a first open position) and a second relaxed position (or a second closed position). Figure 22 shows the first biased position of the spring 1170 (shown in outline), and the spring 1170 is in this position when the delivery catheter 1104 is coupled to the hub 1054. The position where the delivery catheter 1104 is attached to the hub 1054 holds the spring 1170 in the biased position or the first open position. Once the delivery catheter 1104 is removed from the hub 1054, the spring 1170 can spontaneously move to the closed second relaxed position (see Figure 12 ), at which time the occluder flap 1036 (also see Figure 11 ) substantially minimizes or even completely eliminates any through holes adjacent to the proximal surface and adjacent to the hub 1054. In the second relaxed position of the spring 1170, the bore 1158 defined in the hub 1054 is substantially closed by the occluder flap 1036, leaving only a cross-shaped slit (as shown by the adjacent extended occluder flaps 1036 in Figure 11 ), and substantially eliminating any exposed metal at the hub 1054. In this way, the occluder flap 1036 in the closed second position advantageously provides a surface at the proximal side of the device without exposing metal at the hub 1054. In addition, it provides a continuous surface with the polymeric material of the occluder part to close the hub 1054.

[0153] As described above, the spring 1170 can be embedded in the occluder material or tissue growth member 1028, or can be attached to the surface of the inner occluder material, such that the spring 1170 can include various layers and / or folds, such as ePTFE, and one or more slits defining the flaps 1036 facilitate the connection of the delivery catheter 1104 to the hub 1054 when the spring 1170 is in the first biased position, but can substantially close the bore 1158 defined in the hub 1054 when the spring is in the second relaxed position. This arrangement facilitates substantially preventing blood from flowing through the hub 1054, or substantially preventing the potential risk of embolism or thrombus migration from the hub 1054 itself after the medical tool 1020 is positioned in the LAA. In this way, the spring 1170 facilitates closing the through-hole of the hub 1054 and / or covering any metal exposed at the hub, such that preventing embolism or thrombus that can collect on the metal from escaping from the hub. In other words, the flaps 1036 provide a barrier that is substantially impermeable to embolism or thrombus that might otherwise migrate in the hub 1054.

[0154] Now referring to Figure 23A and Figure 23B , the release button 1152 of the actuation handle 1106 is depicted in the figure. The handle housing 1150 defines a hole 1172 that can extend along the longitudinal axis of the handle housing 1150, and the size of the hole is set to hold the plunger shaft 1154 such that the plunger shaft moves bidirectionally therethrough. The handle housing 1150 can also define a hollow portion 1174 therein. The plunger shaft 1154 can extend through the handle housing 1150 and be coupled to the following components, which are coupled to the actuator shaft 1144 and the inner distal connector 1146 at the distal portion of the delivery catheter 1104 (see Figure 9 ). The handle 1106 can also include a leaf spring 1176 that is configured to bias against the release button 1152. The release button 1152 can include a button post 1178. The leaf spring 1176 can be coupled to the button post 1178 to bias the release button 1152 to the popped-up position or the first position. The plunger shaft 1154 can also include two travel stops 1180 fixed thereto. After pressing the release button 1152 to the depressed position or the second position, the button post 1178 depresses the leaf spring 1176 and moves within the cavity 1182. Once the button post 1178 moves within the cavity 1182, the travel stops 1180 coupled to the plunger shaft 1154 can freely move distally (and then proximally back) a predetermined distance past the button post 1178, which is measured by the travel distance of the travel stops 1180 within the hollow portion 1174 defined by the handle housing 1150. In this way, the plunger shaft 1154 can move a predetermined distance, which directly corresponds to the distance or length that the actuator shaft 1144 moves to actuate the anchor portion of the medical tool 1020 between the non-deployed position and the deployed position of the anchor (seeFigure 18 and Figure 19 )。

[0155] Referring back Figure 18 , the sheath 1102 may include an imaging device 1190. It will be apparent to those of ordinary skill in the art that the size and configuration of the imaging device 1190 may be configured to be positioned at the distal end of the sheath 1102, and the imaging device may include one or more lines 1192 that extend proximally from the imaging device 1190 towards the sheath hub 1130 ( Figure 16C ), transmitting imaging information from the imaging device 1190 to a computer and a display (not shown) so that the physician can view the imaging information in real time. After the sheath 1102 is withdrawn from the occluder portion 1024, the sheath is substantially positioned concentric with or proximal to the medical tool 1020, and at this time the sheath may be located at a favorable site and position adjacent to the LAA within the left atrium, thereby providing the physician with detailed imaging information that would otherwise be difficult to obtain. The imaging device 1190 may be an ultrasonic imaging device or any other suitable imaging device known in the art. The imaging device 1190 may be positioned proximal to the distal end of the delivery catheter 1104 in a manner similar to that described above. The distal end of the delivery catheter 1104 and / or the sheath 1102 may include one or more positioning sensors 1191. The positioning sensors 1191 may be configured to sense pressure, flow rate, and any other cardiac dynamics parameters that may be useful to the physician. In this way, the positioning sensors 1191 and / or the imaging device 1190 can provide additional information to assist the physician in accurately positioning the medical tool 1020 within the LAA 1005.

[0156] Now referring Figure 24A and Figure 24B , another embodiment of the medical tool 1200 is provided in the figure, which is coupled to the distal portion of the delivery catheter 1202, and the medical tool 1200 (shown in a simplified profile view) is respectively set in a partially deployed position and a fully deployed position. As described in the previous embodiment, the medical tool 1200 may include an occluder portion 1204 and an anchor portion 1206 that can be deployed separately. For example, once the sheath 1208 is positioned within the LAA (not shown) and the medical tool 1200 is located at its distal end portion, the sheath 1208 is withdrawn to deploy the occluder portion 1204 of the medical tool 1200 or to partially deploy the medical tool 1200. Once the occluder portion 1204 is deployed, the anchor portion 1206 can be deployed to fully deploy the medical tool 1200.

[0157] In this embodiment, the occluder portion 1204 is substantially similar to the previous embodiments, except that the tissue growth member 1210 is attached to the outer surface of the frame member of the occluder portion 1204. The tissue growth member 1210 of this embodiment may include one or more materials similar to the layer-like tissue growth members described in detail in Figure 11B In addition, although the anchor portion 1206 may be coupled to the occluder portion 1204 in a hinged manner, and the hinge arrangement 1212 functions in many respects similar to the previous embodiments, the anchor portion 1206 of this embodiment includes a plurality of independent and distinct anchor frame segments 1214, as best shown in Figure 25 .

[0158] Referring to Figure 25 , the frame members of the occluder portion 1204 and the anchor portion 1206 are shown in a preformed state after being laser cut from a superelastic flat sheet material (such as Nitinol), for example. For simplicity purposes, only one anchor frame segment 1214 is shown, but in this embodiment, there may be five anchor frame segments 1214 to correspond to and couple to, for example, the occluder frame holes 1216 of the occluder portion 1204. As shown, the frame member of the occluder portion 1204 may be substantially similar to the frame member of the occluder portion 1204 described in the previous embodiments in conjunction with Figure 13 .

[0159] Regarding the anchor frame segment 1214, each anchor frame segment 1214 may extend between a first end 1218 and a second end 1220, and two actuator arms 1222 extend therebetween such that each anchor frame segment 1214 may exhibit a "Y" or "V" configuration in the preformed state. Each actuator arm 1222 may include an anchor hinge hole 1224 located at the second end 1220, and at the first end 1218, the actuator arm 1222 may be coupled to a snap ring arrangement 1226 or a spline sleeve, similar to the previous embodiments. With this arrangement, as shown in Figure 24A and Figure 24B , the actuator arms 1222 may pivot about the occluder portion 1204 at the hinge arrangement 1212. In addition, the actuator arms 1222 may form a loop configuration or a loop protrusion at the anchor deployment position, and the first end 1218 of the actuator arms 1222 is capable of being moved or actuated through the hub 1228 of the medical tool 1200.

[0160] Now referring to Figure 26A , Figure 26B and Figure 27 , a partial deployment position ( Figure 26A ) and a fully deployed position ( Figure 26B are shown similar to the previous embodiments.)Another embodiment of the medical tool 1250. In this embodiment, the occluder portion 1252 may be similar to the previous embodiments, but the anchor portion 1254 may include an anchor zigzag portion 1256 and a loop extension 1258 or an actuator arm as separate anchor frame components. In this embodiment, the medical tool 1250 may include a double-hinged arrangement. For example, the occluder portion 1252 may be pivotally coupled to the anchor zigzag portion 1256, and the first hinge arrangement 1260 and the anchor zigzag portion 1256 may be pivotally coupled to the loop extension 1258 and the second hinge arrangement 1262. The profile and function of the medical tool 1250 may be similar to the previous embodiments, except that due to the second hinge arrangement 1262 therebetween, the loop extension 1258 may form a more direct inward angle with the anchor zigzag portion 1256. Similar to Figure 25 embodiments, this embodiment may include ten loop extensions 1258 or actuator arms, but for simplicity purposes, only two loop extensions 1258 (as a single loop extension segment) are shown in Figure 27 . It should be noted that the embodiments of FIGS. 24 and 26 also provide a feature structure that facilitates cushioning the tip (not shown) when retracted into the sheath 1264 as shown in Figure 17 . Additionally, it should be noted that the alternatives shown and described in connection with Figure 11 , FIGS. 24 and 26 include similar features and structures, and thus, the description provided in one embodiment may also apply to the other embodiments described.

[0161] Now referring to Figures 28 to 30 , another alternative for a medical tool 1300 and a medical tool delivery system 1302 for modifying the LAA 1005 of the heart is provided. According to this alternative of the second exemplary embodiment, the structural components and functionality of the medical tool 1300 and the medical tool delivery system 1302 may be substantially similar to any of the previous embodiments. For example, the medical tool 1300 may include an occluder portion 1306 and an anchor portion 1308, similar to those described above.

[0162] According to this alternative, when the medical tool 1300 is positioned within the LAA 1005 and the anchor portion 1308 is deployed to engage the tissue of the LAA 1005, the medical tool delivery system 1302 and the medical tool 1300 may include a common flow path 1310 defined therethrough for injecting fluid 1304 through the hub 1312 of the medical tool 1300 and to the distal side of the medical tool 1300 and into the LAA 1005. An important aspect of this alternative may be that the occluder portion 1306 of the medical tool includes a substantially impermeable material such as a polymeric material (such as foam and / or ePTFE) described in the previous embodiments herein as a tissue growth member. The ePTFE may be an impermeable material.

[0163] The occluder portion 1306 of the medical tool 1300 may comprise a polymeric material such as the foam and / or ePTFE described previously. The polymeric material may include a biologic agent coated on or impregnated within the polymeric material. Such a biologic agent may be configured to enhance tissue growth and endothelialization above the proximal side of the occluder portion 1306 of the medical tool 1300. Alternatively or additionally, the polymeric material may include a coating thereon, which may be an antithrombogenic agent coating such as Heprin. In addition to or in place of the aforementioned polymeric materials, the occluder portion may include biologic tissue. Such biologic tissue may be tissue of biologic origin such as pericardial tissue and / or peritoneal tissue, or any suitable biologic tissue known in the art to be biocompatible. Additionally, the biologic tissue may be impermeable, resilient, and thin to facilitate movement between a collapsed configuration and a deployed configuration with the lacrimal punctum occluder portion frame structure. Additionally, the impermeable nature of the pericardial tissue may be used to substantially contain the fluid 1304 within the LAA 1005 when the medical tool is positioned within the LAA. Alternatively or additionally, the biologic tissue may be permeable, or include portions with permeable characteristics and other portions with impermeable characteristics.

[0164] Reference Figure 28 , Figure 28A and Figure 28B , the medical tool delivery system 1302 includes a sheath 1316, a delivery catheter 1318 coupled to a handle 1320, and a medical tool 1300 coupled to the distal end of the delivery catheter 1318, similar to that described herein in connection with Figure 14The system(s) described and shown (as well as other embodiments herein). A delivery catheter 1318 extends between a proximal end and a distal end such that the proximal end is coupled to a handle 1320 and the distal end of the delivery catheter 1318 is coupled to an implantable medical tool 1300. Additionally, the delivery catheter 1318 defines a lumen 1322 that extends along the longitudinal length of the delivery catheter 1318. The handle 1320 may include a fluid port 1324 sized and configured to be in direct communication with the lumen 1322 of the delivery catheter 1318. Additionally, the delivery catheter 1318 may include an actuator shaft 1326 extending therethrough (coupled to the handle 1320 and actuatable by an actuation knob 1321) for controlling actuation of an anchor portion 1308 of the medical tool 1300. With this arrangement, fluid may be injected through the fluid port 1324 of the handle 1320 and directly through the lumen 1322 of the delivery catheter 1318 such that the fluid may be advanced toward the medical tool 1300. Additionally, a distal portion of the delivery catheter 1318 may include at least one sensor 23. Additionally or alternatively, a proximal portion of the delivery catheter 1318 may include at least one sensor 23.

[0165] As described in previous embodiments, the delivery catheter 1318 and the medical tool 1300 coupled at its distal end may be sized and configured to be pushed through a cannula lumen 1317 defined along the length of a sheath 1316. The sheath 1316 may also include a sheath fluid port 1328 sized and configured to inject fluid and pass the fluid through the cannula lumen 1317 and out of the distal end of the sheath 1316. Additionally, a distal portion of the sheath 1316 may include at least one sensor 23.

[0166] Fluid may be injected using an injection device 1330 through the fluid port 1324 of the handle 1320 and the sheath fluid port 1328 of the sheath 1316. The injection device 1330 may be a syringe for manual injection through the fluid port 1324 of the handle 1320 or through the sheath fluid port 1328 of the sheath 1316. Alternatively or additionally, the injection device 1330 may include an injector that controls the pressure, amount, and / or flow rate of the fluid injected through the fluid port 1324 of the handle 1320 (or through the sheath fluid port 1328 of the sheath 1316), as would be known to one of ordinary skill in the art.

[0167] Now referring Figure 29 and Figure 30 , in the case where the medical device 1300 is positioned in the LAA 1005, fluid may flow through the lumen 1322 of the delivery catheter 1318, as described above, and through a hub 1312 (and associated components) of the medical tool 1300. When the fluid exits the hub 1312 of the medical tool 1300, asFigure 29 As shown by arrow 1332 in, the fluid mixes with the blood in the LAA 1005. Since the occluder portion 1306 has a substantially impermeable material associated therewith, if the medical tool 1300 is properly positioned within the LAA 1005, then the fluid can remain substantially within the LAA 1005, but there is no discernible source or gap for general seepage around the outer periphery 1314 of the medical tool 1300. The meaning of keeping the fluid substantially within the LAA is to keep the fluid substantially contained, persistent, and / or retained within the LAA, ignoring general seepage along the outer periphery 1314. Relative to Figure 30 , Figure 30A and Figure 30B , the flow path of the fluid flowing through the hub 1312 from the delivery catheter 1318 will now be described (as shown by arrow 1310 in Figure 30 ). The flow path 1310 extends through the lumen 1322 of the delivery catheter 1318 and moves around and along the length of the actuator shaft 1326 and the delivery catheter 1318. Figure 30 The cross-section 30C identified in can be substantially similar to the cross-section described and shown in Figure 28A , which depicts the delivery catheter 1318 defining the lumen 1322 and the actuator shaft 1326 positioned therethrough. The flow path 1310 continues to advance along the clip 1336 and then outward into the space 1334 or passage defined between the clip fingers 1338 (see Figure 30 and Figure 30A ). The flow path 1310 continues to advance between the inner distal connector 1340 and the delivery catheter 1318 and then between the inner distal connector 1340 and the medical tool 1300 (only the hub 1312 is shown), as shown in Figure 30 and Figure 30A . The hub 1312 includes a guide ring 1342 that can be inserted into the inner diameter or bore 1344 defined within the hub 1312 itself. The guide ring 1342 includes a hole 1346 defined therein (see Figure 30B), the flow path 1310 extends through the aperture. The aperture 1346 may include an annular space or a partially annular configuration or space. Alternatively or additionally, the inner diameter or bore may include an annular protrusion instead of the guide ring 1342 such that the bore 1344 between the annular protrusion and the inner distal connector 1340 may define an annular space through which the flow path 1310 extends (instead of through the aperture 1346). Once the flow path 1310 continues through the aperture 1346 or annular space and past the guide ring 1342 or annular protrusion in the bore 1344, the flow path 1310 will continue through the bore 1344 of the hub 1312 and advance distally over the inner distal connector 1340. The inner distal connector 1340 may include threads along its inner diameter for coupling to threads on the proximal end of the anchor hub 1350. The flow path 1310 continues to advance through the hub 1312 until it exits the hub 1312, as shown by arrow 1332, such that fluid 1304 may enter the LAA 1005 on the distal side of the medical tool 1300, as Figure 29 shown. With this arrangement, each of the handle 1320, delivery catheter 1318, and hub 1312 of the medical tool 1300 includes a common, shared, or corresponding flow path 1310 that facilitates the outflow of fluid 1304 on the distal side of the medical tool 1300.

[0168] Reference Figure 31 , the system 2100 for occlusion detection may include a sheath 1102, a delivery system 1022, a medical tool 1020, at least one sensor 23 as described above, and a processing device 2101. The system 2100 may further include a memory 2102 and a display device 2103. The processing device 2101, memory 2102, and display device 2103 may be part of a computing device 2110. The system 2100 may optionally include additional sensors located throughout the system. The computing device 2110 may also include an I / O interface.

[0169] The at least one sensor 23 may be configured to detect at least one physical property of blood. As described above, the at least one sensor 23 is located on the distal portion of the sheath 1102. Additionally or alternatively, the at least one sensor 23 may be located on the distal end of the delivery catheter. Additionally or alternatively, the at least one sensor 23 may be located on the proximal end of the delivery catheter. Additional sensors may be located elsewhere throughout the system. For example, as Figure 11 , Figure 11A , Figure 11B , Figure 12 , Figure 14 , Figure 16C , Figure 28 and Figure 29As shown, the sensors are located at exemplary positions, including outside and inside the occlusion portion 1024. Although not shown in the figures, one or more sensors 23 may also be located outside or inside the anchoring portion 1026.

[0170] The at least one sensor 23 may include a temperature sensor, and the at least one characteristic includes temperature. Alternatively or additionally, the at least one sensor 23 includes a first electrode and a second electrode, and the at least one characteristic may include bipolar electrical impedance. Alternatively or additionally, the at least one sensor 23 may include a first electrode and a second electrode, and the second electrode may be a reference electrode, and the at least one characteristic may include monopolar electrical impedance. Alternatively or additionally, the at least one sensor 23 may include a pH sensor, and the at least one characteristic may include pH.

[0171] The processing device 2101 may include one or more processors. The processing device 2101 may be configured to process blood characteristic data obtained from the at least one sensor 23. The processing device 2101 may be further configured to record the at least one characteristic of the blood over time.

[0172] The display device 2103 may include one or more displays configured to display the at least one characteristic of the blood data over time. The display device 2103 may display the at least one characteristic of the blood over time in a meaningful manner (such as a chart or graph). The display device 2103 may be further configured to display the baseline characteristics of the blood next to or above the at least one characteristic of the blood over time. The processing device 2101 may be further configured to determine whether there is an occlusion by comparing the at least one blood characteristic data over time with the baseline of the at least one characteristic of the blood. Additionally or alternatively, the processing device 2101 may be further configured to determine whether there is an occlusion in the LAA based on how quickly the at least one characteristic of the blood returns to its original value. Additionally or alternatively, the processing device 2101 may be further configured to record the at least one blood characteristic of the LAA and the at least one characteristic of the blood in the left atrium, and compare the at least one characteristic of the blood in the LAA with the at least one characteristic of the blood in the left atrium. Alternatively or additionally, the processing device 2101 may be further configured to use the comparison of the at least one characteristic of the blood in the LAA with the at least one characteristic of the blood in the left atrium to determine whether there is an occlusion in the LAA; and use the at least one characteristic of the blood in the LAA and the at least one characteristic of the blood in the left atrium to determine whether there is an occlusion in the left atrium.

[0173] The at least one sensor 23 may communicate with the processing device 2101 in a wired or wireless manner. The display device 2103 may also communicate with the processing device 2101 in a wired or wireless manner.

[0174] The system may further include a memory 2102. The memory 2102 may include a storage device for storing data. The memory 2102 may be configured to store measurements of the at least one characteristic of the blood. Alternatively or additionally, the memory 2102 may be configured to store a baseline of the at least one characteristic of the blood. The memory 2102 may include any volatile and / or non-volatile memory, such as random access memory or a hard disk drive.

[0175] Reference Figure 32 , at step 2201, the medical tool 1020 may be positioned at a target location within a patient's organ, such as the heart, as described above. At step 2202, the occluder portion of the medical tool may be deployed, as described above. At step 2203, when the occluder portion is in the expanded deployed position, the spiked anchor portion 1026 of the medical tool 1020 may move from the retracted position to the anchor deployment position, as described above. At step 2204, a fluid may be injected into the cavity through the delivery catheter, as described above. The fluid may be a coolant. The fluid may be saline. Additionally or alternatively, the fluid may be glucose at a low temperature. Injecting the fluid may change the at least one characteristic of the blood within the target cavity. Thus, a change in the at least one characteristic of the blood may indicate the presence or absence of a blockage. At step 2205, at least one characteristic of the blood is detected via at least one sensor 23. At step 2206, the processing device 2101 processes the at least one characteristic of the blood data detected by the at least one sensor 23. The presence or absence of a blockage is determined by the at least one characteristic of the blood. For example, after injecting the fluid into the target cavity, due to fluid expansion, the at least one characteristic of the blood may change. Fluid expansion may cause changes in blood characteristics, including but not limited to temperature, impedance, and pH. Thus, a change in blood characteristics may indicate a blockage, a partial blockage, or a complete blockage. The physician may observe the fluid expansion change on the display 2103, and the physician may determine the presence or absence of a blockage based on the change. Additionally or alternatively, the processing device 2101 may be further configured to determine the presence or absence of a blockage, as described in more detail below.

[0176] The at least one sensor 23 may be a temperature sensor, and the at least one characteristic of the blood is temperature. Alternatively or additionally, the at least one sensor 23 may be a first electrode and a second electrode, and the at least one characteristic is bipolar electrical impedance. Alternatively or additionally, the at least one sensor 23 may be a first electrode and a second electrode, the second electrode being a reference electrode, and the at least one characteristic is monopolar electrical impedance. Alternatively or additionally, the at least one sensor 23 is a pH sensor, and the at least one characteristic is pH.

[0177] Reference Figure 33 According to a second exemplary embodiment, a baseline measurement of a patient at a relevant anatomical location can be determined by method 2300 and then used as a reference for determining whether there is a complete or partial blockage. At step 2301, the medical tool 1020 can be positioned at a target location within the patient's organ as described above. However, the medical tool 1020 is positioned such that there will be no complete blockage. At step 2302, the occluder portion of the medical tool can be deployed as described above. At step 2303, when the occluder portion is in the expanded deployed position, the barbed anchor portion 1026 of the medical tool 1020 can move from the retracted position to the anchor deployment position as described above. At step 2304, fluid can be injected into the target cavity via the delivery catheter as described above. At step 2305, at least one characteristic of the blood is detected via at least one sensor 23. At step 2306, the processing device 2101 processes the at least one characteristic of the blood data detected by the at least one sensor 23 and establishes the data as a baseline measurement of the at least one characteristic of the blood.

[0178] Optionally or additionally, the method further includes recording measurements of the at least one characteristic of the blood over time via the processing device 2101. The method further includes storing the measurements of the at least one blood characteristic over time in the memory 2102.

[0179] For identifying a blockage using the system 2100 of the present disclosure, it is not necessary to determine the baseline characteristics of the blood. For example, in one embodiment, the at least one characteristic of the blood in the LAA is measured before injecting the fluid. Then the fluid is injected and the at least one characteristic of the blood is observed over a period of time. If the at least one characteristic of the blood returns to the original value relatively quickly, it is assumed that no blockage has occurred. Similarly, if the at least one characteristic of the blood takes a relatively long time to return to its original value, it is assumed that a blockage has occurred. The display can be configured to display the original measurement of the at least one characteristic of the blood and the at least one characteristic of the blood over time after injecting the fluid such that a physician can determine whether there is a blockage. Additionally or alternatively, the processing device 2101 can be further configured to compare the original measurement of the at least one characteristic of the blood and the at least one characteristic of the blood over time after injecting the fluid to determine whether there is a blockage.

[0180] The cusp teeth of the anchor member portion 1026 can be configured to engage tissue with the LAA and the left atrium, as described above, and the method 2100 can be performed twice: once on the left atrium and once on the LAA. The LAA measurement and the left atrium measurement can be performed simultaneously. The display device 2103 can be configured to display the at least one characteristic of the blood in the left atrium and the at least one characteristic of the blood in the LAA such that a physician can compare the measured values to determine whether a blockage exists. For example, if the at least one characteristic of the blood changes in a similar manner within the LAA and the left atrium, it is assumed that no blockage has occurred. If the at least one characteristic of the blood changes in a different manner within the LAA and the left atrium, it is assumed that a blockage has occurred. Additionally or alternatively, the processing device 2101 can be configured to compare the at least one characteristic of the blood in the left atrium and the at least one characteristic of the blood in the LAA and determine whether a blockage exists. Regarding Figure 32 and Figure 33 The methods described and shown are also algorithms that a skilled software engineer can utilize to generate the necessary step-by-step computer code to implement the entire method in a computer system (e.g., a general-purpose computer or a special-purpose computer, such as a Carto system) such that the embodiments described herein can be used to detect blockages.

[0181] It should be understood that many variations are possible based on the disclosure of the first and second exemplary embodiments herein. While the features and elements have been described above in specific combinations, each feature or element can be used alone without the other features and elements, or each feature or element can be used in various combinations with or without the other features and elements.

Claims

1. A system for occlusion detection, comprising: a sheath having a lumen defined by a sheath wall, the sheath extending a length in a proximal-distal direction; a delivery system comprising: a catheter extending between a proximal end and a distal end, the catheter comprising an internal lumen; and a handle coupled to the proximal end of the catheter; a medical tool coupled to a distal portion of the distal end of the catheter, the medical tool comprising: an inflatable balloon coupled to the sheath, the inflatable balloon comprising a distal end and a proximal end defining a longitudinal axis and a membrane formed by a plurality of perfusion pores, wherein the inflatable balloon is inflated when positioned at a target cavity within a patient; at least one sensor configured to sense an original value of at least one characteristic of blood in the target cavity before introducing a fluid into the target cavity and to sense a value of the at least one characteristic of blood in the target cavity over time after introducing the fluid into the target cavity; and at least one processor configured to: process the value of the at least one characteristic of blood over time after introducing the fluid into the target cavity obtained from the at least one sensor, and determine a time from when the fluid is introduced into the target cavity to when the value of the at least one characteristic of blood over time after introducing the fluid into the target cavity returns to the original value of the at least one characteristic of blood in the target cavity before introducing the fluid into the target cavity, and determine the presence or absence of an occlusion based on the time, wherein the target cavity is the left atrial appendage or the left atrium, wherein the at least one processor is configured to: record at least one characteristic of blood in the left atrial appendage and at least one characteristic of blood in the left atrium over time; use a comparison of the at least one characteristic of blood in the left atrial appendage with the at least one characteristic of blood in the left atrium to determine whether there is an occlusion in the left atrial appendage and use a comparison of the at least one characteristic of blood in the left atrial appendage with the at least one characteristic of blood in the left atrium to determine whether there is an occlusion in the left atrium, such that if the at least one characteristic of blood in the left atrial appendage and the at least one characteristic of blood in the left atrium change in a similar manner, it is assumed that no occlusion has occurred, and if the at least one characteristic of blood in the left atrial appendage and the at least one characteristic of blood in the left atrium change in a different manner, it is assumed that an occlusion has occurred.

2. The system according to claim 1, wherein the distal end of the catheter comprises a snare portion extending through the distal portion of the inflatable balloon, and the at least one sensor is located on one or more of the distal end of the inflatable balloon, the proximal end of the inflatable balloon, and the snare portion of the catheter.

3. The system according to claim 1, wherein the at least one sensor is located on one or more of the distal end of the inflatable balloon, the proximal end of the inflatable balloon, the distal end of the catheter, and the proximal end of the catheter.

4. The system according to claim 1, wherein the at least one sensor includes a temperature sensor, and the at least one characteristic of the blood includes temperature.

5. The system according to claim 1, wherein the at least one sensor includes a first electrode and a second electrode, and the at least one characteristic includes bipolar electrical impedance.

6. The system according to claim 1, wherein the at least one sensor includes a first electrode and a second electrode, the second electrode is a reference electrode, and the at least one blood characteristic includes monopolar electrical impedance.

7. The system according to claim 1, wherein the at least one sensor includes a pH sensor, and the at least one characteristic of the blood includes pH.

8. The system according to claim 1, wherein the processor is further configured to determine whether there is a blockage by comparing at least one blood characteristic data over time with a baseline of the at least one characteristic of the blood.

9. The system according to claim 1, wherein the processor is configured to perform an algorithm based on the at least one blood characteristic to determine the presence or absence of a blockage, or to determine a number indicating the degree of blockage.

10. A system for blockage detection, comprising: a sheath having a length and a sheath lumen extending through the length of the sheath; a delivery system comprising: a delivery catheter extending between a proximal end and a distal end; and a handle coupled to the proximal end of the delivery catheter; a medical tool coupled to the distal end of the delivery catheter at a target location within a portion of a patient's organ, the medical tool comprising: a hub including a bore defining an axis; an occluder portion coupled to the hub, the occluder portion being configured to be moved to an occluder non-deployed position, wherein the occluder portion is within the distal portion of the sheath; and the occluder portion being configured to be moved to an occluder deployed position when the sheath is moved proximally relative to the occluder portion; and an anchor portion extending between a first end and a second end, the anchor portion having barbs configured to engage tissue, the first end coupled to the handle, and the second end pivotally coupled to a distal end portion of the occluder portion, wherein when the occluder portion maintains the occluder deployed position, the anchor portion is pivotable relative to the occluder portion between an anchor non-deployed position and an anchor deployed position; At least one sensor configured to detect an original value of at least one physical property of blood in the target cavity before injecting a fluid into the target cavity of a patient and to detect a value of the at least one physical property of blood in the target cavity over time after injecting the fluid into the target cavity; and At least one processor configured to: process the value of the at least one physical property of blood over time obtained from the at least one sensor after injecting the fluid into the target cavity, and determine a time from when the fluid is introduced into the target cavity until the value of the at least one physical property of blood over time after injecting the fluid into the target cavity returns to the original value of the at least one physical property of blood in the target cavity before injecting the fluid into the target cavity, and determine the presence or absence of a blockage based on the time, wherein the target cavity is the left atrial appendage or the left atrium, wherein the barbs of the anchoring portion engage the tissue with the left atrial appendage and the left atrium, wherein the at least one processor is configured to: record at least one property of blood in the left atrial appendage and at least one property of blood in the left atrium over time; use a comparison of the at least one property of blood in the left atrial appendage with the at least one property of blood in the left atrium to determine whether there is a blockage in the left atrial appendage and use a comparison of the at least one property of blood in the left atrial appendage with the at least one property of blood in the left atrium to determine whether there is a blockage in the left atrium, such that if the at least one property of blood in the left atrial appendage and the at least one property of blood in the left atrium change in a similar manner, it is assumed that no blockage has occurred, and if the at least one property of blood in the left atrial appendage and the at least one property of blood in the left atrium change in a different manner, it is assumed that a blockage has occurred.

11. The system according to claim 10, wherein the at least one sensor comprises a temperature sensor and the at least one physical property of blood is temperature.

12. The system according to claim 10, wherein the at least one sensor comprises at least two electrodes.

13. The system according to claim 10, wherein the at least one sensor comprises a pH sensor and the at least one physical property of blood comprises pH.

14. The system according to claim 10, wherein the at least one sensor is located on a distal portion of the sheath.

15. The system according to claim 10, wherein the at least one sensor is located on a distal end of the delivery catheter.

16. The system according to claim 10, wherein the at least one sensor is located on a proximal end of the delivery catheter.

17. The system according to claim 10, wherein the processor is further configured to compare the at least one physical property of the blood obtained from the at least one sensor with a baseline blood property.

18. The system according to claim 10, wherein the processor is further configured to record measurements of the at least one physical property of the blood over time.

Images