Adjustable balloon fixation for sheath

Abstract

The present invention is entitled "Adjustable Balloon Fixation for a Sheath". The present invention provides a tool positioning system for use in a medical procedure, the tool positioning system comprising a medical tool configured to be navigated to a target tool position within a portion of an organ of a patient. The medical tool comprises: a sheath having a tube defined by a sheath wall, the sheath extending a certain length in a proximal-distal direction; and an inflatable balloon connected to the sheath and configured to move in the proximal-distal direction along the length of the sheath. When the inflatable balloon is inflated at a target balloon position along the length of the sheath, the inflatable balloon is fixed at the target balloon position. The tool positioning system also includes a memory configured to store the position of the tool in a three-dimensional (3D) space and at least one processor configured to generate mapping information for displaying the position of the tool in the 3D space.

Description

Summary of the invention

[0001] The present invention provides a tool positioning method, the method comprising positioning a medical tool including a sheath and an inflatable balloon coupled to the sheath at a target tool location within a portion of an organ of a patient. The method further comprises moving the inflatable balloon in a proximal-distal direction along the length of the sheath to the target balloon location, and inflating the inflatable balloon when the balloon is positioned at the target balloon location along the length of the sheath. The method further comprises securing the inflated balloon at the target balloon location along the length of the sheath to prevent the medical tool from moving from the target tool location.

[0002] The present invention provides a medical tool for use in a medical procedure, the medical tool comprising a sheath having a tube defined by a sheath wall. The sheath extends a certain length in a proximal-distal direction. The medical tool also includes an inflatable balloon coupled to the sheath and a balloon movement mechanism coupled to the inflatable balloon. The balloon movement mechanism is configured to move the inflatable balloon to different balloon positions along the length of the sheath. The medical tool also includes a balloon fixing mechanism, which is configured to fix the inflatable balloon in an inflated state to a target balloon position along the length of the sheath to prevent the medical tool from moving from the target tool position within a portion of an organ of a patient.

[0003] The present invention provides a tool positioning system for use in a medical procedure, the tool positioning system comprising a medical tool configured to be navigated to a target tool position within a portion of an organ of a patient. The medical tool comprises: a sheath having a tube defined by a sheath wall, the sheath extending a certain length in a proximal-distal direction; and an inflatable balloon connected to the sheath and configured to move in the proximal-distal direction along the length of the sheath. When the inflatable balloon is inflated at a target balloon position along the length of the sheath, the inflated balloon is fixed at the target balloon position. The tool positioning system also includes a memory configured to store the position of the tool in a three-dimensional (3D) space and at least one processor configured to generate mapping information for displaying the position of the tool in the 3D space.

[0004] These and other objects, features and advantages will become apparent from the following detailed description of illustrative embodiments of the present invention, which is to be read in connection with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0005] A more detailed understanding may be obtained from the following description given by way of example in conjunction with the accompanying drawings, in which:

[0006] Figure 1 is an illustration of an exemplary medical system for navigating tools in a 3D space in which embodiments disclosed herein may be implemented;

[0007] Figure 2 is a block diagram illustrating components of an exemplary medical system for use with the embodiments described herein;

[0008] Figure 3 is an illustration of an exemplary medical tool positioned within a portion of a heart for use with embodiments described herein;

[0009] Figure 4 is a schematic diagram showing components of an exemplary medical tool according to an embodiment;

[0010] Figure 5 To illustrate the embodiment according to Figure 4 A flow chart of an exemplary method of positioning a tool at a target location on a patient's anatomy is shown;

[0011] Fig. 6A is a schematic diagram showing a portion of an exemplary medical tool having a sheath, a balloon, and a collapsible element according to an embodiment;

[0012] Figure 6B is a diagram showing an exemplary collapsible protrusion in a collapsed position and an engaged position relative to a cavity disposed inside a balloon;

[0013] Figure 7 To illustrate the embodiment according to Fig. 6A A flow chart of an exemplary method of securing a sheath at a target location within a patient's anatomy is shown;

[0014] Fig. 8A shows a portion of a tool having a locking mechanism according to an embodiment;

[0015] Figure 8B for Fig. 8A an enlarged cross-sectional view of a portion of the illustrated tool showing the locking mechanism in a closed position;

[0016] Figure 8C for Fig. 8A an enlarged cross-sectional view of a portion of the illustrated tool showing the locking mechanism in an open position; and

[0017] Fig. 9 Shown is a portion of a tool having a sheath, an inflatable balloon having an inflatable portion and a non-inflatable portion, and a pair of rings according to an embodiment. DETAILED DESCRIPTION

[0018] The sheath can be used in intravascular, intracardiac or any intraluminal invasive medical procedures. For example, the sheath can be a tool or part of a tool for an electromagnetic navigation system that is used to determine the position of the sheath in 3D space during a medical procedure. The sheath allows devices (such as catheters, guidewires, and needles, etc.) to pass through the sheath and to aspirate in a specific location of the patient's anatomy. The sheath facilitates navigation through the patient's anatomy, thereby bending the device through the anatomy in a determined direction and maintaining a desired balance between stiffness and flexibility (and in some cases, force), thereby guiding, stabilizing, and using the device in a specific location in the patient's body.

[0019] When the sheath is positioned at a target location of a patient (eg, in the heart) during a medical procedure, the sheath is typically passed through a puncture or existing fossa (ie, a transseptal puncture). During the procedure, the location of the sheath serves as an access point to the target location.

[0020] In some cases, after the sheath is positioned at the target location, the sheath may move (e.g., slide) from its target location, requiring re-access to the target location and / or repositioning of the sheath. For example, when the sheath is positioned in the right atrium (e.g., by a cardiologist), the sheath passes through the fossa ovalis in the septum into the left atrium. The fossa ovalis is a depression in the septal tissue that is used as a marker to indicate to the physician the location at which the sheath can be inserted from the right atrium through the septum into the left atrium. When the sheath enters the left atrium, the sheath may slide back into the right atrium, resulting in a loss of access to the sheath. However, re-accessing the sheath and / or repositioning the sheath is time consuming and presents additional risks (e.g., risk of injury) to the patient.

[0021] Embodiments disclosed herein provide a device and method that utilizes a medical tool having an inflatable balloon to position a portion of the medical tool (e.g., a sheath) at a target tool location (e.g., a location appropriate for the size and anatomy of the organ) within an organ of a patient's anatomy (e.g., the left atrium), and to secure the portion of the tool at the target tool location by inflating the balloon at the target location to prevent or limit movement of the tool at the target location in the organ.

[0022] Embodiments disclosed herein provide systems, tools, and methods for adjusting the position of a balloon on a tool (eg, a sheath of a tool) and securing (eg, locking) an inflatable balloon at a specific position on a tool.

[0023] Embodiments disclosed herein provide a sheath that can be a tool or part of a tool for a medical system for generating and displaying information (e.g., a diagram, an anatomical model of a portion of a patient, and signal information). In some embodiments, the medical system can be an electromagnetic navigation system for determining the position of the tool and / or sheath in 3D space during medical procedures. During these medical procedures, the medical tool generates and transmits a signal (e.g., an electrical signal based on the amplitude and phase of a magnetic field) to facilitate determining its position.

[0024] Figure 1 is an illustration of an exemplary medical system 20 that may be used to generate and display information 52 (eg, a graph, an anatomical model of a portion of a patient, and signal information). Figure 1 The system 20 and tool 22 shown are exemplary only. A medical tool such as tool 22 may be any tool used for diagnostic or therapeutic treatment, such as for mapping electrical potentials in a heart 26 of a patient 28. Alternatively, the tool may be used mutatis mutandis for other therapeutic and / or diagnostic purposes in a different portion of the anatomy, such as in the heart, lungs, or other body organs, such as the ear, nose, and throat (ENT). Tools may include, for example, sheaths, probes, catheters, cutting tools, and suction devices.

[0025] Operator 30 may insert tool 22 into a portion of the patient's anatomy (e.g., the vascular system of patient 28) such that tip 56 of tool 22 enters a chamber of heart 26. Console 24 may use magnetic position sensing to determine the 3D position coordinates of the tool (e.g., the coordinates of tip 56) inside heart 26. To determine the position coordinates, driver circuitry 34 in console 24 may drive field generator 36 via connector 44 to generate a magnetic field within the anatomy of patient 28.

[0026] Field generator 36 includes one or more transmitter coils ( Figure 1 ), the transmitting coil is configured to generate a magnetic field in a predetermined working volume containing a portion of interest of the patient's anatomy. Each transmitting coil can be driven by a different frequency to emit a constant magnetic field. For example, Figure 1 In the illustrated example medical system 20 , one or more transmitter coils may be positioned beneath the torso of a patient 28 , and each transmitter coil is configured to generate a magnetic field in a predetermined working volume that includes the patient's heart 26 .

[0027] like Figure 1As shown, the magnetic field position sensor 38 is disposed at the tip 56 of the tool 22. The magnetic field position sensor 38 generates an electrical signal indicating the 3D position coordinates of the tool (e.g., the position coordinates of the tip 56) based on the amplitude and phase of the magnetic field. The electrical signal can be transmitted to the console 24 to determine the position coordinates of the tool. The electrical signal can be transmitted to the console 24 via the wire 45.

[0028] Alternatively, or in addition to wired communication, the electrical signal may be wirelessly transmitted to the console 24, for example, via a wireless communication interface (not shown) at the tool 22, and the tool 22 may communicate with an input / output (I / O) interface 42 in the console 24. For example, U.S. Pat. No. 6,266,551, the disclosure of which is incorporated herein by reference, describes, among other things, a wireless catheter that is not physically connected to a signal processing and / or computing device and is incorporated herein by reference. Instead, a transmitter / receiver is attached to the proximal end of the catheter. The transmitter / receiver communicates with the signal processing and / or computer device using a wireless communication method (e.g., IR, RF, Bluetooth, or an acoustic transmission device). The wireless digital interface and the I / O interface 42 may operate according to any suitable wireless communication standard known in the art, such as IR, RF, Bluetooth, one of the IEEE 802.11 family of standards (e.g., Wi-Fi), or a HiperLAN standard.

[0029] although Figure 1 A single magnetic field position sensor 38 is shown disposed at the tip 56 of the tool 22, but the tool may include one or more magnetic field position sensors, each disposed at any tool portion. The magnetic field position sensor 38 may include one or more microcoils (not shown). For example, the magnetic field position sensor may include a plurality of microcoils oriented along different axes. Alternatively, the magnetic field position sensor may include another type of magnetic sensor or other type of position transducer, such as an impedance-based position sensor or an ultrasonic position sensor.

[0030] Signal processor 40 is configured to process the signals to determine position coordinates, including both position coordinates and orientation coordinates, of tool 22. The position sensing method described above is implemented in the CARTO mapping system produced by Biosense Webster Inc. of Diamond Bar, California, and is described in detail in the patents and patent applications cited herein.

[0031] The tool 22 may also include a force sensor 54 housed within the distal end 32. The force sensor 54 may measure the force applied to the endocardial tissue of the heart 26 by the tool 22 (e.g., the tip 56 of the tool) and generate a signal that is sent to the console 24. The force sensor 54 may include a magnetic field transmitter and receiver connected by a spring in the distal end 32, and may generate an indication of the force based on measuring the deflection of the spring. Further details of such probes and force sensors are described in U.S. Patent Application Publications 2009 / 0093806 and 2009 / 0138007, the disclosures of which are incorporated herein by reference. Alternatively, the distal end 32 may include another type of force sensor that may use, for example, optical fiber or impedance measurement.

[0032] The tool 22 may also include an electrode 48 coupled to the distal end 56 and configured to function as an impedance-based position transducer. Additionally or alternatively, the electrode 48 may be configured to measure a physiological property, such as a local surface potential at one or more locations (e.g., a local surface potential of cardiac tissue). The electrode 48 may be configured to apply RF energy to ablate endocardial tissue in the heart 26.

[0033] Although the example medical system 20 can be configured to use a magnetic-based sensor to measure the position of the tool 22, other position tracking techniques (e.g., impedance-based sensors) can be used. Magnetic position tracking techniques are described, for example, in U.S. Patents 5,391,199, 5,443,489, 6,788,967, 6,690,963, 5,558,091, 6,172,499, 6,177,792, the disclosures of which are incorporated herein by reference. Impedance-based position tracking techniques are described, for example, in U.S. Patents 5,983,126, 6,456,828, and 5,944,022, the disclosures of which are incorporated herein by reference.

[0034] The I / O interface 42 can enable the console 24 to interact with the tool 22, the body surface electrodes 46, and any other sensors (not shown). Based on the electrical pulses received from the body surface electrodes 46 and the electrical signals received from the tool 22 via the I / O interface 42 and other components of the medical system 20, the signal processor 40 can determine the position of the tool in 3D space and generate display information 52 that can be shown on the display 50.

[0035] The signal processor 40 may be included in a general purpose computer having a suitable front end and interface circuitry for receiving signals from the tool 22 and controlling other components of the console 24. The signal processor 40 may be programmed using software to perform the functions described herein. The software may be downloaded to the console 24 in electronic form, such as over a network, or may be provided on a non-transitory tangible medium such as an optical, magnetic or electronic memory medium. Alternatively, some or all of the functions of the signal processor 40 may be performed by dedicated or programmable digital hardware components.

[0036] exist Figure 1 In the illustrated example, the console 24 is connected via a cable 44 to body surface electrodes 46, each of which is attached to the patient's skin using a patch (e.g., Figure 1 The surface electrodes 46 are attached to the patient 28 (indicated in FIG. 4 as a circle around the electrode 46). The surface electrodes 46 may include one or more wireless sensor nodes integrated on a flexible substrate. The one or more wireless sensor nodes may include a wireless transmit / receive unit (WTRU) capable of local digital signal processing, a radio link, and a miniaturized rechargeable battery. In addition to or in place of the patch, the surface electrodes 46 may be positioned on the patient using an article including the surface electrodes 46 worn by the patient 28, and may also include one or more position sensors (not shown) indicating the position of the worn article. For example, the surface electrodes 46 may be embedded in an article (e.g., a vest) disposed on the patient 28. During operation, the surface electrodes 46 assist in providing the position of a tool (e.g., a tool including an inflatable balloon) in 3-D space by detecting electrical pulses generated by polarization and depolarization of cardiac tissue and transmitting the information to the console 24 via the cable 44. The surface electrodes 46 may be equipped with magnetic position tracking and may help identify and track the respiratory cycle of the patient 28. In addition to or in lieu of wired communications, body surface electrodes 46 may communicate with console 24 and each other via a wireless interface (not shown).

[0037] During diagnostic processing, the signal processor 40 may present display information 52 and may store data representing the information 52 in a memory 58. The memory 58 may include any suitable volatile and / or non-volatile memory, such as a random access memory or a hard drive. The operator 30 may be able to manipulate the display information 52 using one or more input devices 59. Alternatively, the medical system 20 may include a second operator manipulating the console 24 while the operator 30 manipulates the tool 22. It should be noted that Figure 1 The configuration shown is exemplary. Any suitable configuration of medical system 20 may be used and implemented.

[0038] Figure 2 is a block diagram illustrating example components of a medical system 200 for use with the embodiments described herein. Figure 2 As shown, system 200 includes medical tool 222, processing device 204, display device 206, and memory 212. Processing device 204, display device 206, and memory 212 are part of computing device 214. In some embodiments, display device 206 may be separate from computing device 214. Computing device 214 may also include I / O interfaces, such as Figure 1 An I / O interface 42 is shown.

[0039] Tool 222 includes an array of electrodes 208, each electrode being configured to detect electrical activity (electrical signals) of a region of an organ (e.g., a heart) over time. When performing an ECG, each electrode detects electrical activity of the region of the organ in contact with the electrode. Tool 222 also includes a plurality of sensors 208. Sensors 208 include, for example, magnetic field position sensors (e.g., Figure 1 28) for providing a position signal to indicate the 3D position coordinates of the tool 222. In some procedures, one or more additional sensors 210 separate from the tool 222, as shown in the exemplary system 200, are also used to provide a position signal. The additional sensors 210 may also include sensors (e.g., electrodes on the patient's skin) for assisting in detecting electrical activity of the heart by detecting electrical changes on the skin due to electrophysiological patterns of an organ such as the heart. The tool 222 also includes an inflatable balloon 202 that can be adjusted and inflated at a target location in the patient's organ to secure the tool 222 at the target location by preventing or limiting movement of the tool 222 at the target location, as described in more detail below.

[0040] The processing device 204 may include one or more processors, each of which is configured to process ECG signals, record ECG signals over time, filter ECG signals, fractionate ECG signals into signal components (e.g., slope, wave, complex wave), and generate and combine ECG signal information for displaying multiple electrical signals on the display device 206. The processing device 204 may also generate and interpolate mapping information for displaying a 3D map of the heart on the display device 206. The processing device 204 may include one or more processors (e.g., signal processor 40) configured to process position information obtained from sensors (e.g., additional sensor 210 and sensor 216) to determine position coordinates (including both position coordinates and orientation coordinates) of the tool 222.

[0041] In addition, the processing device 204 determines the location of the anatomical region of the organ (e.g., the heart) on the map, determines which electrical signals correspond to the region of the organ located within the anatomical region of the organ, and generates signal information (e.g., related ECG information) for displaying the electrical signals determined to correspond to the region of the organ located within the anatomical region of the organ (i.e., determined to be electrical signals acquired by electrodes (i.e., poles) disposed at the corresponding region of the organ). The processing device 204 drives the display device 206 to display the dynamic map of the organ (i.e., spatiotemporal map) and the electrical activity of the organ using the mapping information and the signal information. The processing device 204 also drives the display device 206 to display the signals determined to be located within the anatomical region of the heart using the related signal information.

[0042] The display device 206 may include one or more displays each configured to display a 3D map of the organ representing a spatiotemporal representation of the electrical activity of the organ over time, and to display electrical signals acquired from the organ over time. For example, a 3D map of the organ representing the electrical activity of the organ at a particular time interval and the electrical signals acquired from the organ during the time interval may be displayed simultaneously on the same display device. Alternatively, the 3D map of the organ and the electrical signals acquired during the same time interval may be displayed on separate display devices.

[0043] Electrodes 208, sensors 216, and additional sensors 210 may communicate with processing device 204 in wired or wireless communication. Display device 206 may also communicate with processing device 204 in wired or wireless communication.

[0044] Figure 3 is an illustration of an exemplary medical tool positioned within a portion of a heart for use with embodiments described herein. Figure 3 In the example shown, the medical tool 322 includes a sheath 301 (including a shaft or tube) and an inflatable balloon 302 coupled to (eg, directly or indirectly connected to) the sheath 301 . Figure 3 The sheath 301 and balloon 302 are shown positioned in the left atrium 303 of the heart after having entered the left atrium 303 from the right atrium 304. The balloon 302 is shown in an inflated state within the left atrium 303, providing stability by preventing the sheath 301 from moving (e.g., sliding back) into the right atrium 304.

[0045] Although Tool 322 Figure 3 322 is shown in the heart, but the use of tool 322 in the heart is an example. Tool 322 can be used in other organs and other parts of the patient's anatomy. Figure 3The illustrated position of balloon 302 about the axis of sheath 301 is also exemplary. Balloon 302 can be adjusted to different positions about the axis of sheath 301 to accommodate different procedures, users and anatomies, as well as different sheath and catheter manipulation strategies.

[0046] Figure 4 Schematic diagram showing the components of tool 422 according to an embodiment. Tool 422 includes a sheath 401 and a rotatable handle 406 connected to the sheath via a line 407. Sheath 401 includes an inflatable balloon 402 and a spring element 403, which is connected to the balloon 402 and connected to the line 407 in the wall of the sheath 401. The spring element 403 is configured to expand and contract to adjust the balloon 402 to different positions along the sheath 401. Each spring element 403 may include a coil spring. The spring element may also include other types of spring-like mechanisms configured to adjust the balloon 402 to different positions along the sheath 401. In addition, the sheath may include any number of spring elements (including a single spring element) to adjust the balloon 402 to different positions along the sheath 401. The tool may include any number of lines (including a single line) to adjust the balloon 402 to different positions along the sheath 401.

[0047] The rotatable handle 406 includes a screw element 404 disposed within the rotatable handle 406. The screw element 404 may be, for example, a screw having a thread configured to rotatably engage with an opposing thread of the sheath. The spring element 403, the rotatable handle 406, the screw element 404, and the wire 407 together form a balloon movement mechanism for moving the balloon 402 to different positions along the sheath 401. For example, the rotatable handle 406 is rotated around the screw element 404 to apply a force (e.g., a push or pull, depending on the rotation direction of the rotatable handle 406) to the wire 407, thereby causing the spring element 403 coupled to the wire 407 to extend or contract. The extension and contraction of the spring element 403 causes the balloon 402 coupled to the spring element 403 to move in opposite directions along the sheath 401.

[0048] Figure 5 To illustrate the embodiment according to Figure 4 Flowchart of an exemplary method 500 for positioning and securing a portion of a tool 422 at a target tool location within an anatomical structure of a patient. As indicated at block 502, the method 500 includes positioning a tool 422 (e.g., a sheath 401 of the tool 422) within a portion of an organ, such as Figure 3303 is shown in the left atrium 303. As shown in box 504, method 500 includes rotating the rotatable handle 406 to move (i.e., adjust) the balloon 402 to a target balloon position along the sheath 401. For example, rotating the rotatable handle 406 (e.g., by a physician) about the screw element 404 causes the spring element 403 to expand or contract via the wire 407. The expansion of the spring element 403 causes the balloon 402 to move along the sheath 401 in one direction, and the contraction of the spring element 403 causes the balloon 402 to move along the sheath 401 in the opposite direction.

[0049] When the balloon reaches the target balloon position along the sheath 401, the rotation of the rotatable handle 406 stops and the balloon 402 is inflated, as shown in box 506. The inflated balloon 502 is then fixed at the target balloon position along the sheath 501, as shown in box 508. For example, the balloon 402 is fixed at the target balloon position by locking the balloon 402 at the target balloon position using a locking mechanism (such as those described herein). Thus, the sheath 401 is prevented from moving from the target tool position to another position within the patient's anatomy (e.g., from sliding out of the left atrium 303). The above method 500 can be facilitated using ultrasound, fluorescence imaging, or other techniques known to those skilled in the art.

[0050] Fig. 6A 622 is a schematic diagram showing components of a tool 622 according to an embodiment. Fig. 6A As shown, tool 622 includes a sheath 601 having a sheath wall 603 , a balloon 602 , a collapsible element 604 , a protrusion wire 605 , a first balloon wire 606 , and a second balloon wire 607 .

[0051] The first balloon wire and the second balloon wire are linear elements that can be moved (pulled and released) to facilitate Fig. 6A The sheath 601 is shown positioned at a target tool location of a patient (e.g., a target location within the left atrium of the heart). Balloon wires 606 and 607 together form a balloon movement mechanism for adjusting the position of the balloon 602 along the length of the sheath axis, while the protrusion wire 605 is used to fix (e.g., lock) the balloon 602 at the target location along the sheath 601. For example, the first balloon wire 606 can be used to move the balloon 602 along the sheath 601 in a direction from the proximal side of the sheath 601 to the distal side (closer to the tip) of the sheath 601. The second balloon wire 306 can be used to move the balloon 602 along the sheath 601 in the opposite direction from the distal side of the sheath 601 to the proximal side of the sheath 601. Fig. 6A The number of balloon wires shown is exemplary only. The balloon movement mechanism may include any number of balloon wires to adjust the position of balloon 602 along sheath 601.

[0052] Figure 6B 604a and 604b are diagrams showing exemplary collapsible projections in collapsed and engaged positions relative to a cavity 602a disposed on an inner side 608 of a balloon 602. Fig. 6A An example of a collapsible element 604 is shown. Figure 6B As shown, collapsible protrusions 604a and 604b (e.g., tooth-shaped protrusions) are disposed on the sheath wall 603. The collapsible protrusion 604a is shown in its collapsed position. The collapsible protrusion 604b is shown in an engaged (i.e., extended) position. The balloon 602 includes a cavity 602a disposed on the inner side 608 of the balloon 602, which engages and disengages the collapsible protrusions 604a and 604b disposed on the sheath wall 603 to adjust the balloon 602 to different positions along the length of the sheath 601 and prevent (e.g., lock) the balloon 602 from moving along the length of the sheath 601. The number of protrusions 604a and cavities 602a and their positions are shown in Figure 6B The positions in are merely exemplary. In another embodiment, a cavity disposed on the sheath wall may engage a collapsible protrusion disposed on the inner side of the balloon.

[0053] For example, when the target position of the balloon is obtained along the proximal-distal direction, the balloon 102 is inflated and the protrusion line 605 is pulled to cause the protrusions 604a and 604b to move to their engaged positions until the collapsible protrusions 604a and 604b align with and engage the cavity 602a of the balloon 602. When the protrusions 604a and 604b engage with the cavity 602a, the protrusion line 605 is released and the balloon 602 is fixed or locked at the target position. Fig. 6A Rotate the sheath 601 in the direction indicated by arrow 610 in FIG. 6 to align the collapsible protrusions 604a and 604b with the cavity 602a.

[0054] Figure 7 To illustrate the embodiment according to Fig. 6A Flow chart of an exemplary method 700 for securing a sheath 601 at a target tool location within a patient's anatomy. As indicated at block 702, the method 700 includes positioning the sheath 601 within a portion of an organ, such as Figure 3 As shown in the left atrium 303. As shown in block 704, the method 700 includes moving one or both of the balloon wires 606 and 607 coupled to the balloon 602 to move (i.e., adjust) the balloon along the sheath 601. For example, the balloon wires 606 and 607 can be used to adjust the position of the balloon 602 in opposite directions along the sheath 601.

[0055] As shown in block 706, the method 700 includes inflating the balloon 602 when the target balloon position along the sheath 610 is obtained. As shown in block 708, the method 700 includes fixing the balloon 602 at the target position along the sheath 601. For example, the protrusion line 605 can be pulled until the collapsible element 604 (e.g., one or more collapsible protrusions 604a) engage with the one or more relative cavities 602a. When the one or more collapsible protrusions 604a engage with the one or more relative cavities 602a, the protrusion line 605 is released and the balloon 602 is fixed (e.g., locked) at the target position on the sheath 601. The above method 700 can be facilitated using ultrasound, fluorescence imaging, or other techniques known to those skilled in the art.

[0056] Fig. 8A A portion of an exemplary tool 822 having a locking mechanism 804 is shown according to an embodiment. Fig. 8A As shown, tool 822 includes a sheath 801 having a sheath wall 803, an inflatable balloon 802, a locking mechanism line 806, a first balloon line 808, and a second balloon line 809. Sheath 801 includes a fan-shaped element 810, which includes a fan-shaped element 810 disposed on the sheath wall 803. Figure 8B and Figure 8C The first balloon line 808 includes a fan-shaped element 812 opposite to the fan-shaped element 810 disposed on the sheath arm 803, and the fan-shaped element includes a fan-shaped element 812 shown in FIG. Figure 8B and Figure 8C The fan-shaped protrusion 812a in the. Fig. 8A The second balloon wire 809 shown does not include a scalloped element. Some embodiments include a second balloon wire 809 having a scalloped element. Embodiments may include any number of balloon wires, including a single balloon wire.

[0057] Figure 8B for Fig. 8A An enlarged cross-sectional view of a portion of the sheath 801 and balloon 802 is shown illustrating the locking mechanism 804 in a closed position. Figure 8C for Fig. 8A An enlarged cross-sectional view of a portion of the sheath 801 and balloon 802 is shown, showing the locking mechanism 804 in an open position. The locking mechanism includes a locking mechanism wire 806 and a pivot arm 814. The pivot arm is configured to pivot about a pivot point 816. The pivot arm 814 is coupled to the locking mechanism wire 806 at the pivot end (via a connector not shown) and is coupled to the scallop 810a at the balloon end via the balloon 802. Figure 8C In the open position shown, the scallops 812a on the sheath wall 803 are spaced apart from the opposing scallops 810a on the balloon 802. Figure 8BIn the closed position shown, the scalloped protrusion 812a on the sheath wall 803 moves closer to the opposing scalloped protrusion 810a on the balloon 802. For example, when the locking mechanism line 806 is moved (pushed or pulled), the pivot arm 814 is caused to pivot about the pivot point 816 so that the pivot arm 814 is in the closed position. Figure 8B and Figure 8C and causes the fan-shaped protrusion 810a to move between the positions shown in Figure 8B and Figure 8C In addition, unlike Fig. 6A and Figure 6B The protrusion 604a, scalloped protrusions 810a and 812a in the illustrated embodiment are non-collapsible.

[0058] Figures 8A-8C Each of the protrusions 810a are shown to be equally spaced apart from one another. Figures 8A-8C Each of the protrusions 812a is also shown as being equally spaced from one another. However, embodiments may include unequal spacing between protrusions. Figures 8A-8C The number and positions of protrusions 810a and 812a shown are exemplary. Embodiments may include any number of protrusions. Fig. 6A and Figure 6B , embodiments may include a balloon movement mechanism that includes any number of balloon wires to adjust the position of the balloon 802 along the sheath 801.

[0059] After the tool 822 is positioned at the target location of the patient's organ (eg, the left atrium 103), the first balloon wire 808 is pulled, thereby causing the balloon 802 to extend along the sheath 801 in the proximal-distal direction (ie, Figures 8A-8C Move in the left-right direction in the Figure 8C As shown in the position in FIG. 1 , the fan-shaped protrusion 810a and the fan-shaped protrusion 812a are separated from each other so that they can move in opposite directions (i.e., left and right directions) without contacting each other, thereby enabling the balloon 802 to move to the target position. When the balloon 802 reaches the target position along the sheath 801, the locking mechanism line 806 is moved (e.g., pulled), thereby causing the fan-shaped protrusion 810a and the opposite fan-shaped protrusion 812a to move closer to each other (i.e., in Figures 8A-8C in the up-down direction) until the locking mechanism 804 is closed and the protrusions 810a and 812a reach their positions as shown in FIG. Figure 8B position in the middle and secures (e.g., locks) the balloon 802 at the target balloon position along the sheath 801.

[0060] Fig. 9 A portion of a tool 922 is shown according to an embodiment. Fig. 9As shown, tool 922 includes a sheath 901 having a sheath wall 903, a balloon 902 covering a distal portion of the sheath 902, a pair of rings 904 and 905, a wire 906 disposed within the sheath wall 903, a catheter 907, and a saline tube 908. The rings 904 and 905 disposed on each side of the balloon 902 are spaced apart from each other and are configured to slide on the balloon 902. The distance between the two rings 904 and 905 is determined by a fixing element (in Fig. 9 904 and 905), thereby allowing the rings 904 and 905 to move together distally and proximally ( Fig. 9 The balloon 902 is moved in the left-right direction (in the left-right direction) while maintaining an equal distance between each other. The balloon 902 has an inflatable portion 902a disposed between the rings 904 and 905 and non-inflatable portions 902b and 902c disposed on both sides of the rings 904 and 905. The inflatable portion 902a depends on the flow of saline via the saline tube 908. Therefore, the position and size of the inflatable portion 902a of the balloon 902 depends on the position of the rings 904 and 905, which block the flow of saline, thereby causing the balloon 902 to inflate between the rings 904 and 905. Similar to the above-described embodiments, the balloon movement mechanism may include any number of balloon wires to adjust the position of the balloon 902 to different positions along the sheath 901. A saline tube 908 enters the balloon 902 between the loops 904 and 905 and is attached to a puller wire of the balloon 902 to inflate the inflatable portion 902a of the balloon 902 between the loops 904 and 905 with saline.

[0061] After the tool 922 is positioned at a target location of an organ (e.g., the left atrium 103) of the patient, the wire 906 is used to move the rings 904 and 905 along the balloon 902 to different locations along the sheath 901. As the balloon is moved, the rings 904 and 905 may slide along the balloon-covered distal portion of the sheath 901. When the target location of the rings 904 and 905 along the balloon 902 is obtained, the balloon 902 is fixed (e.g., locked) in place by inflating an inflatable portion 902a of the balloon 902, which is a portion located between the rings 904 and 905 depending on the position of the rings 904 and 905 after adjustment.

[0062] The provided methods may be implemented in a general purpose computer, a processor, or a processor core. By way of example, suitable processors include a general purpose processor, a special purpose processor, a conventional processor, a digital signal processor (DSP), a plurality of microprocessors, one or more microprocessors associated with a DSP core, a controller, a microcontroller, an application specific integrated circuit (ASIC), a field programmable gate array (FPGA) circuit, any other type of integrated circuit (IC), and / or a state machine. Such processors may be manufactured by configuring a manufacturing process using the result of processed hardware description language (HDL) instructions and other intermediate data including a network table (such instructions can be stored on a computer readable medium). The result of such processing may be a mask work that is subsequently used in a semiconductor manufacturing process to manufacture a processor that implements the features of the present disclosure.

[0063] The methods or flow charts provided herein may be implemented in a computer program, software or firmware incorporated into a non-transitory computer-readable storage medium for execution by a general-purpose computer or processor. Examples of non-transitory computer-readable storage media include read-only memory (ROM), random access memory (RAM), registers, cache memory, semiconductor memory devices, magnetic media (e.g., internal hard disks and removable disks), magneto-optical media, and optical media (e.g., CD-ROM disks and digital versatile disks (DVDs)).

[0064] It should be understood that many variations are possible based on the disclosure herein. Although features and elements are described above in particular combinations, each feature or element may be used alone without other features and elements, or each feature or element may be used in various combinations with or without other features and elements.

Claims

1. A medical tool for use in a medical procedure, comprising: a sheath having a tube defined by a sheath wall, the sheath extending a length in a proximal-distal direction; an inflatable balloon coupled to the sheath; a balloon movement mechanism coupled to the inflatable balloon and configured to move the inflatable balloon to different balloon positions along the length of the sheath; and a balloon securing mechanism configured to secure the inflatable balloon in an inflated condition to a target balloon position along the length of the sheath to prevent movement of the medical tool from the target tool position within a portion of an organ of a patient, The medical tools also include: A plurality of first fan-shaped protrusions, wherein the plurality of first fan-shaped protrusions are arranged on the jacket wall; a first balloon wire coupled to the inflated balloon and comprising a plurality of second scalloped protrusions opposite the plurality of first scalloped protrusions; and a locking mechanism coupled to at least one of the plurality of first fan-shaped protrusions and the plurality of second fan-shaped protrusions and configured to move between a first position and a second position, wherein when the locking mechanism is in the first position, the plurality of first fan-shaped protrusions are spaced apart from the plurality of second fan-shaped protrusions so that the inflatable balloon is allowed to move in the proximal-distal direction, and When the locking mechanism is in the second position, the plurality of first scalloped protrusions and the plurality of second scalloped protrusions are configured to engage each other and prevent the inflated balloon from moving in the proximal-distal direction.

2. The medical tool according to claim 1, further comprising: A locking wire is coupled to the locking mechanism.

3. A tool positioning system for use in a medical procedure, comprising: A medical tool configured to be navigated to a target tool location within a portion of an organ of a patient, the medical tool comprising: a sheath having a tube defined by a sheath wall, the sheath extending a length in a proximal-distal direction; and an inflatable balloon coupled to the sheath and configured to move in the proximal-distal direction along the length of the sheath, wherein when the inflatable balloon is inflated at a target balloon location along the length of the sheath, the inflated balloon is secured at the target balloon location; a memory configured to store position data corresponding to the acquired position signal indicating a position of the tool in a three-dimensional (3D) space including the organ of the patient; and at least one processor configured to generate mapping information from the position data for indicating the position of the tool in the three-dimensional (3D) space, The medical tools also include: A plurality of first fan-shaped protrusions, wherein the plurality of first fan-shaped protrusions are arranged on the jacket wall; a first balloon wire coupled to the inflated balloon and comprising a plurality of second scalloped protrusions opposite the plurality of first scalloped protrusions; and a locking mechanism coupled to at least one of the plurality of first fan-shaped protrusions and the plurality of second fan-shaped protrusions and configured to move between a first position and a second position, wherein when the locking mechanism is in the first position, the plurality of first fan-shaped protrusions are spaced apart from the plurality of second fan-shaped protrusions so that the inflatable balloon is allowed to move in the proximal-distal direction, and When the locking mechanism is in the second position, the plurality of first scalloped protrusions and the plurality of second scalloped protrusions are configured to engage each other and prevent the inflated balloon from moving in the proximal-distal direction.

4. The tool positioning system of claim 3, wherein the medical tool further comprises: A locking wire is coupled to the locking mechanism.

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