Adjustable balloon fastening for sheath

Abstract

Positioning medical tools. [Solution] A tool positioning system for use in medical procedures is provided, which includes a medical tool configured to navigate to a target tool position within a portion of a patient's organs. The medical tool includes a sheath having a tube defined by a sheath wall, the sheath extending a certain length in the proximal-distal direction, and an inflatable balloon connected to the sheath and configured to move along the length of the sheath in the proximal-distal direction. 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 three-dimensional (3D) space, and at least one processor configured to generate mapping information for displaying the position of the tool in 3D space.

Description

Background Art

[0001] There is provided a tool positioning method including positioning a medical tool including a sheath and an inflatable balloon connected to the sheath at a target tool position within a part of a patient's organ. The method also includes moving the inflatable balloon in a proximal-distal direction along the length of the sheath to a target balloon position, and inflating the inflatable balloon when the balloon is positioned at the target balloon position along the length of the sheath. The method further includes fixing the inflated balloon at the target balloon position along the length of the sheath to prevent the medical tool from moving from the target tool position.

[0002] There is provided a medical tool for use in a medical procedure, including 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 connected to the sheath and a balloon movement mechanism connected 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 configured to fix the inflatable balloon at a target balloon position along the length of the sheath when inflated, to prevent the medical tool from moving from a target tool position within a part of a patient's organ.

[0003] A tool positioning system for use in medical procedures is provided, which includes a medical tool configured to navigate to a target tool position within a portion of a patient's organs. The medical tool includes a sheath having a tube defined by a sheath wall, the sheath extending a certain length in the proximal-distal direction, and an inflatable balloon connected to the sheath and configured to move along the length of the sheath in the proximal-distal direction. 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 three-dimensional (3D) space, and at least one processor configured to generate mapping information for displaying the position of the tool in 3D space.

[0004] These and other purposes, features, and advantages will become apparent from the following detailed description of exemplary embodiments, which should be interpreted in conjunction with the attached drawings. [Brief explanation of the drawing]

[0005] A more detailed understanding can be achieved from the following explanation, which is provided as an example along with the attached diagram. [Figure 1] This figure shows an exemplary medical system for navigating tools in a functional 3D space as described herein. [Figure 2] A block diagram showing an exemplary component of a medical system to be used with the embodiments described herein. [Figure 3] This figure shows an exemplary medical tool positioned in conjunction with a portion of the heart, for use with the embodiments described herein. [Figure 4] This figure shows the components of an exemplary medical tool according to one embodiment. [Figure 5] This flowchart illustrates an exemplary method for positioning the tool shown in Figure 4 at a target location on a patient's anatomical structure, according to one embodiment. [Figure 6A]This figure shows a part of an exemplary medical tool having a sheath, balloon, and foldable element according to one embodiment. [Figure 6B] This figure shows an example of a foldable projection in its folded and engaged positions relative to a cavity located inside a balloon. [Figure 7] This flowchart illustrates an exemplary method for fixing the sheath shown in Figure 6A to a target location within the patient's anatomical structure, according to one embodiment. [Figure 8A] A part of a tool having a locking mechanism according to one embodiment is shown. [Figure 8B] This is a cross-sectional view of a portion of the tool shown in Figure 8A, illustrating the locking mechanism in the closed position. [Figure 8C] Figure 8A is an enlarged cross-sectional view of a portion of the tool shown, illustrating the locking mechanism in the open position. [Figure 9] The image shows a part of a tool according to one embodiment, which includes a sheath, an inflatable balloon having an inflatable portion and a non-inflatable portion, and a pair of rings. [Modes for carrying out the invention]

[0006] The sheath may be used in intravascular, intracardiac, or any intracavitary invasive medical procedure. For example, the sheath may be a tool or part of an electromagnetic navigation system used to determine the position of the sheath in 3D space during a medical procedure. The sheath allows a device (such as a catheter, guidewire, and needle) to pass through the sheath and to be aspirated at a specific location in the patient's anatomical structure. The sheath facilitates navigation through the patient's anatomical structure, bending the device as it passes through the sheath in a determined direction, and maintaining a desired balance between rigidity and flexibility (and possibly force) to orient, stabilize, and use the device at a specific location within the patient's body.

[0007] When positioning the sheath at a target location in the patient (e.g., within the heart) during a medical procedure, the sheath typically passes through a puncture site or an existing cavity (i.e., a transseptal puncture). During the procedure, the sheath's position serves as an access point to the target location.

[0008] Depending on the situation, after the sheath has been positioned at the target location, it may move (e.g., slip) from that target location, requiring 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 enters the left atrium through the fossa ovale within the septum. The fossa ovale is a depression in the tissue of the septum, which is used as a marker to indicate to the physician where the sheath can be inserted from the right atrium through the septum into the left atrium. When the sheath enters the left atrium, it may backflow into the right atrium, resulting in a loss of access to the sheath. However, regaining access to the sheath and / or repositioning the sheath is time-consuming and poses an additional risk to the patient (e.g., risk of trauma).

[0009] Embodiments disclosed herein provide apparatus and methods for using a medical tool having an inflatable balloon, which positions a portion of the medical tool (e.g., a sheath) at a target tool location (e.g., a location suitable for organ size and anatomical structure) within an organ of a patient's anatomical structure (e.g., left atrium), and fixes the portion of the tool at the target tool location (by inflating the balloon at the target location to prevent or restrict the movement of the tool at the target location within the organ).

[0010] Embodiments disclosed herein provide systems, tools, and methods for adjusting the position of a balloon on a tool (e.g., on the sheath of the tool) and for fixing (e.g., locking) an inflatable balloon in place on the tool.

[0011] Embodiments disclosed herein provide a tool or sheath, which may be part of a tool, used to generate and display information (e.g., charts, partial anatomical models of a patient, and signal information) in a medical system. In some embodiments, the medical system may be an electromagnetic navigation system used to determine the position of the tool and / or sheath in 3D space during a medical procedure. During these medical procedures, the medical tools generate and transmit signals (e.g., electrical signals based on the amplitude and phase of a magnetic field) to facilitate the determination of their position.

[0012] Figure 1 shows an exemplary medical system 20 that can be used to generate and display information 52 (e.g., charts, anatomical models of parts of a patient, and signal information). The system 20 and tool 22 shown in Figure 1 are merely examples. Medical tools such as tool 22 may be any tools used for diagnostic or therapeutic procedures such as electromapping within the heart 26 of a patient 28. Alternatively, the tools may be used for other therapeutic and / or diagnostic purposes in various anatomical parts such as the heart, lungs, or other human organs (e.g., ear, nose, and throat (ENT)). Examples of tools include sheaths, probes, catheters, cutting tools, and suction devices.

[0013] Operator 30 can insert the tool 22 into a part of the patient's anatomical structure (e.g., the patient's vascular system) so that the tip 56 of the tool 22 enters the cavity of the heart 26. The control console 24 may use magnetic position detection to determine the three-dimensional position coordinates of the tool inside the heart 26 (e.g., the coordinates of the tip 56). To determine the position coordinates, a drive circuit 34 in the control console 24 can drive a magnetic field generator 36 via a connector 44 to generate a magnetic field within the anatomical structure of the patient 28.

[0014] The magnetic field generator 36 includes one or more emitter coils (not shown in Figure 1) positioned at known locations outside the patient 28, each configured to generate a magnetic field within a predetermined working area containing a target portion of the patient's anatomical structure. Each emitter coil can be driven at various frequencies to emit a constant magnetic field. For example, in the exemplary medical system 20 shown in Figure 1, one or more emitter coils may be positioned beneath the torso of the patient 28, each configured to generate a magnetic field within a predetermined working area containing the patient's heart 26.

[0015] As shown in Figure 1, a magnetic field position sensor 38 is positioned at the tip 56 of the tool 22. Based on the amplitude and phase of the magnetic field, the magnetic field position sensor 38 generates an electrical signal indicating the three-dimensional position coordinates of the tool (e.g., the position coordinates of the tip 56). The electrical signal can be transmitted to the control console 24 to determine the position coordinates of the tool. The electrical signal may also be transmitted to the control console 24 via a wire 45.

[0016] Alternatively, or in addition to wired communication, electrical signals may be wirelessly transmitted to the control console 24 via a wireless communication interface (not shown) of a tool 22 that can communicate with the input / output (I / O) interface 42 of the control console 24. For example, U.S. Patent No. 6,266,551, whose disclosure is incorporated herein by reference, describes, among other things, a wireless catheter that is not physically connected to a signal processing device and / or computing device, which is incorporated herein by reference. More precisely, the transceiver is attached to the proximal end of the catheter. The transceiver communicates with the signal processing device and / or computer device using a wireless communication method such as, for example, IR transmission, RF transmission, Bluetooth transmission, or acoustic transmission. The wireless digital interface and I / O interface 42 can operate according to any suitable wireless communication standard known in the art, such as IR, RF, Bluetooth, one of the IEEE 802.11 standard family (e.g., Wi-Fi), or the HiperLAN standard.

[0017] Figure 1 shows a single magnetic field position sensor 38 positioned at the tip 56 of the tool 22, but the tool may include one or more magnetic field position sensors, each positioned at any part of the tool. The magnetic field position sensor 38 may include one or more miniature coils (not shown). For example, the magnetic field position sensor may include a number of miniature coils oriented along different axes. Alternatively, the magnetic field position sensor may include either another type of magnetic sensor or another type of position detector (e.g., an impedance-based position sensor or an ultrasonic position sensor).

[0018] The signal processor 40 is configured to determine the position coordinates of the tool 22, including both the position and orientation coordinates, by processing signals. The above-described position detection method is implemented in a CARTO mapping system manufactured by Biosense Webster Inc. (Diamond Bar, Calif.) and is described in detail in the patents and patent applications cited herein.

[0019] The tool 22 may also include a force sensor 54 housed within the distal end 32. The force sensor 54 can 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 transmitted to the control 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 indicator of force based on the measurement of the spring deflection. Further details of this type of probe and force sensor are described in U.S. Patent Application Publication Nos. 2009 / 0093806 and 2009 / 0138007, the disclosures of which are incorporated herein by reference. Additionally, the distal end 32 may include another type of force sensor that can use, for example, optical fibers or impedance measurements.

[0020] The tool 22 may include electrodes 48 that are coupled to the tip 56 and configured to function as an impedance-based position detector. Additionally or alternatively, the electrodes 48 may be configured to measure certain physiological properties, such as local surface potentials (e.g., the potential of heart tissue) at one or more locations. The electrodes 48 may be configured to apply RF energy to ablate the endocardial tissue of the heart 26.

[0021] The exemplary medical system 20 can be configured to measure the position of the tool 22 using a magnetic-based sensor, although other position tracking techniques may be used (e.g., impedance-based sensors). Magnetic position tracking techniques are described, for example, in U.S. Patent Nos. 5,391,199, 5,443,489, 6,788,967, 6,690,963, 5,558,091, 6,172,499, and 6,177,792, the disclosures of which are incorporated herein by reference. Impedance-based position tracking techniques are described, for example, in U.S. Patent Nos. 5,983,126, 6,456,828, and 5,944,022, the disclosures of which are incorporated herein by reference.

[0022] The I / O interface 42 enables interaction between the control console 24 and the tool 22, body surface electrodes 46, and any other sensors (not shown). The signal processor 40 can determine the position of the tool in 3D space and generate display information 52 based on electrical impulses received from the body surface electrodes 46 and electrical signals received from the tool 22 via the I / O interface 42 and other components of the medical system 20, and this information can be presented on the display 50.

[0023] The signal processor 40 can be included in a general-purpose computer having front-end circuits and interface circuits suitable for receiving signals from the tool 22 and controlling other components of the control console 24. The signal processor 40 may be programmed using software to perform the functions described herein. The software may be downloaded to the control console 24 in electronic form via a network, or may be provided on a non-transitory tangible medium such as an optical, magnetic, or electronic recording medium. Alternatively, some or all of the functions of the signal processor 40 may be performed by dedicated or programmable digital hardware components.

[0024] In the embodiment shown in Figure 1, a control console 24 is connected to surface electrodes 46 via a cable 44, and each of the surface electrodes 46 is attached to a patient 28 using a patch that adheres to the patient's skin (for example, shown as a circle around the electrode 46 in Figure 1). The surface electrodes 46 may include one or more wireless sensor nodes integrated on a flexible substrate. One or more wireless sensor nodes may include a wireless transmit / receive unit (WTRU) that enables local digital signal processing, a wireless link, and a small rechargeable battery. In addition to or instead of patches, the surface electrodes 46 may also be placed on the patient using an article containing the surface electrodes 46 that is worn by the patient 28, and may include one or more position sensors (not shown) that indicate the position of the worn article. For example, the surface electrodes 46 may be embedded in an article (e.g., a vest) placed on the patient 28. During surgery, the surface electrodes 46 help provide the position of a tool (e.g., a tool including an inflatable balloon) in 3D space by detecting electrical impulses resulting from the polarization and depolarization of cardiac tissue and transmitting the information to the control console 24 via the cable 44. The surface electrodes 46 may also be equipped with a magnetic position tracking device, which may help identify and track the respiratory cycle of the patient 28. In addition to or instead of wired communication, the surface electrodes 46 may communicate with and with the control console 24 via a wireless interface (not shown).

[0025] During a diagnostic procedure, the signal processor 40 can present display information 52 and store data representing the information 52 in memory 58. Memory 58 may include any suitable volatile and / or non-volatile memory, such as random-access memory or a hard disk 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 who operates the control console 24 while the operator 30 operates the tool 22. Note that the configuration shown in Figure 1 is illustrative. Any suitable configuration of the medical system 20 can be used and implemented.

[0026] Figure 2 is a block diagram showing exemplary components of a medical system 200 for use with embodiments described herein. As shown in Figure 2, the system 200 includes a medical tool 222, a processing device 204, a display device 206, and a memory 212. The processing device 204, the display device 206, and the memory 212 are part of a computing device 214. In some embodiments, the display device 206 may be separated from the computing device 214. The computing device 214 may also include an I / O interface, such as the I / O interface 42 shown in Figure 1.

[0027] Tool 222 includes an array of electrodes 208, each configured to detect electrical activity (electrical signals) in a region of an organ (e.g., the heart) over time. When an ECG is performed, each electrode detects electrical activity in the region of the organ that is in contact with the electrode. Tool 222 also has a plurality of sensors 208. Sensors 208 include, for example, a magnetic field position sensor (e.g., sensor 38 in Figure 1) for providing a position signal indicating the 3D position coordinates of tool 222. In some procedures, one or more additional sensors 210 separated from tool 222 are also used to provide position signals, as shown in the exemplary system 200. Additional sensors 210 may also include sensors (e.g., electrodes on the patient's skin) used to assist in detecting the electrical activity of an organ by detecting electrical changes on the skin due to the electrophysiological patterns of the organ, such as the heart. Tool 222 also includes an inflatable balloon 202 which may be adjusted and inflated at a target location within the patient's organs to fix Tool 222 in the target location by preventing or limiting the movement of Tool 222 at the target location, as described in more detail below.

[0028] The processing device 204 may include one or more processors for displaying multiple electrical signals on the display device 206, each configured to process the ECG signal, record the ECG signal over time, filter the ECG signal, split the ECG signal into single components (e.g., slope, wave, complex), and generate and combine ECG signal information. The processing device 204 can 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 positional information obtained from sensors (e.g., additional sensors 210 and 216) to determine the positional coordinates of the tool 222, including both positional and orientational coordinates.

[0029] In addition, the processing device 204 determines the location of the anatomical region of an organ (e.g., the heart) on the map, determines which electrical signals correspond to the organ regions located within the organ's anatomical region, and generates signal information (e.g., correlated ECG information) for displaying the electrical signals determined to correspond to the organ regions located within the organ's anatomical region (i.e., determined to be electrical signals acquired by electrodes (i.e., poles) placed in the corresponding regions of the organ). The processing device 204 uses the mapping information and signal information to drive the display device 206 for displaying the organ's dynamic map (i.e., spatiotemporal map) and the organ's electrical activity. The processing device 204 also uses the correlated signal information to drive the display device 206 to display the signals determined to be located within the organ's anatomical region.

[0030] The display device 206 may include one or more display units, each configured to display a 3D map of an organ representing the spatiotemporal manifestation of the organ's electrical activity over time, and to display electrical signals acquired from the organ over time. For example, a 3D map of an organ representing the organ's electrical activity over a specific time interval and electrical signals acquired from the organ during that time interval can be displayed simultaneously on the same display device. Alternatively, the 3D map of the organ and electrical signals acquired during the same time interval can be displayed on separate display devices.

[0031] The electrodes 208, the sensor(s) 216, and the additional sensor(s) 210 may be connected to the processing device 204 by wire or wireless communication. The display device 206 may also be connected to the processing device 204 by wire or wireless communication.

[0032] Figure 3 shows an exemplary medical tool positioned with a portion of the heart for use with embodiments described herein. In the example shown in Figure 3, the medical tool 322 comprises a sheath 301 (equipped with a shaft or tube) and an inflatable balloon 302 connected to the sheath 301 (e.g., directly or indirectly). Figure 3 shows the sheath 301 and balloon 302 positioned within the left atrium 303 of the heart after entering the left atrium 303 from the right atrium 304. The balloon 302 is shown in an inflated state inside the left atrium 303, providing stability by preventing the sheath 301 from moving (e.g., regurgitating) into the right atrium 304.

[0033] Although tool 322 is shown on the heart in Figure 3, the use of tool 322 in the heart is an example. Tool 322 may be used in other organs and other parts of the patient's anatomical structure. The position of balloon 302 around the shaft of sheath 301 shown in Figure 3 is also an example. Balloon 302 is adjustable to different positions around the shaft of sheath 301 to suit different procedures, users, and anatomical structures, as well as sheath and catheter handling strategies.

[0034] Figure 4 shows the components of a tool 422 according to one embodiment. The tool 422 includes a sheath 401 and a rotatable handle 406 connected to the sheath via a wire 407. The sheath 401 includes an inflatable balloon 402 and a spring element 403 connected to the balloon 402 within the wall of the sheath 401 and also connected to the wire 407. 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 helical 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. Furthermore, the sheath may include any number of spring elements, including a single spring element, for adjusting the balloon 402 to different positions along the sheath 401. The tool may include any number of wires, including a single wire, for adjusting the balloon 402 to different positions along the sheath 401.

[0035] The rotatable handle 406 includes a threaded element 404 located within the rotatable handle 406. The threaded element 404 may be a screw having threads configured to rotatably engage with opposing threads of the sheath, for example. The spring element 403, the rotatable handle 406, the threaded element 404, and the wire 407 together form a balloon moving mechanism used to move the balloon 402 to different positions along the sheath 401. For example, the rotatable handle 406 is rotated around the threaded element 404 to apply a force (e.g., a pushing or pulling force depending on the direction of rotation of the rotatable handle 406) to the wire 407, causing the spring element 403 connected to the wire 407 to expand or contract. The expansion and contraction of the spring element 403 causes the balloon 402 connected to the spring element 403 to move in opposite directions along the sheath 401.

[0036] Figure 5 is a flowchart illustrating an exemplary method 500 for positioning and securing a portion of the tool 422 shown in Figure 4 to a target tool location within a patient's anatomical structure, according to one embodiment. As shown in block 502, method 500 includes positioning the tool 422 (e.g., the sheath 401 of the tool 422) within a portion of an organ, such as the left atrium 303 shown in Figure 3. As shown in block 504, method 500 includes rotating a rotatable handle 406 to move (i.e., adjust) the balloon 402 to a target balloon location along the sheath 401. For example, the rotatable handle 406 is rotated (e.g., by a physician) around a screw element 404, expanding or contracting a spring element 403 via a wire 407. Expansion of the spring element 403 moves the balloon 402 in one direction along the sheath 401, and contraction of the spring element 403 moves the balloon 402 in the opposite direction along the sheath 401.

[0037] When the balloon reaches the target balloon position along the sheath 401, the rotation of the rotatable handle 406 stops, as shown in block 506, and the balloon 402 is inflated. The inflated balloon 502 is then fixed in place at the target balloon position along the sheath 501, as shown in block 508. The balloon 402 is fixed in place at the target balloon position by locking it in place at the target balloon position, for example, using a locking mechanism as described herein. Thus, the sheath 401 is prevented from moving from the target tool position to another location within the patient's anatomical structure (for example, from sliding out of the left atrium 303). The above method 500 may be facilitated by using ultrasound, fluoroscopy, or other techniques known to those skilled in the art.

[0038] Figure 6A shows the components of a tool 622 according to one embodiment. As shown in Figure 6A, the tool 622 includes a sheath 601 having a sheath wall 603, a balloon 602, a foldable element 604, a protruding wire 605, a first balloon wire 606, and a second balloon wire 607.

[0039] The first and second balloon wires are string-like elements that can be moved (pulled away, released) to facilitate the positioning of the sheath 601 shown in Figure 6A at the patient's target tool location (e.g., a target location in the left atrium of the heart). The balloon wires 606 and 607 together form a balloon movement mechanism, which are used to adjust the position of the balloon 602 along the length of the sheath shaft, while the protruding 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 may be used to move the balloon 602 in the direction along the sheath 601 from the proximal side to the distal side (closer to the tip) of the sheath 601. The second balloon wire 306 may be used to move the balloon 602 in the opposite direction along the sheath 601 from the distal side to the proximal side of the sheath 601. The number of balloon wires shown in Figure 6A is merely illustrative. The balloon movement mechanism may include any number of balloon wires for adjusting the position of the balloon 602 along the sheath 601.

[0040] Figure 6B shows exemplary foldable projections in a folded and engaged position relative to the cavity 602a located inside 608 of the balloon 602. Foldable projections 604a and 604b are examples of the foldable element 604 shown in Figure 6A. As shown in Figure 6B, the foldable projections 604a and 604b (e.g., tooth-shaped projections) are located on the sheath wall 603. Foldable projection 604a is shown in its folded position. Foldable projection 604b is shown in the engaged (i.e., extended) position. The balloon 602 includes a cavity 602a located inside 608 of the balloon 602, which engages with and disengages from foldable projections 604a and 604b located on the sheath wall 603 to adjust the balloon 602 to different positions along the length of the sheath 601 and to prevent (e.g., lock) the balloon 602 from moving along the length of the sheath 601. The number and positions of the projections 604a and cavity 602a shown in Figure 6B are illustrative only. In another embodiment, a cavity located on the sheath wall may engage with foldable projections located inside the balloon.

[0041] For example, once the target position of the balloon is obtained along the proximal-distal direction, the balloon 102 is inflated, and the projection wire 605 is pulled, moving the projections 604a and 604b to their engagement positions until they align and engage with the cavity 602a of the balloon 602. Once the projections 604a and 604b engage with the cavity 602a, the projection wire 605 is released, and the balloon 602 is fixed or locked in the target position. The foldable projections 604a and 604b may also be aligned with the cavity 602a by rotating the sheath 601 in the direction indicated by arrow 610 in Figure 6A.

[0042] Figure 7 is a flowchart illustrating an exemplary method 700 for fixing the sheath 601 shown in Figure 6A to a target tool location within a patient's anatomical structure, according to one embodiment. As shown in block 702, method 700 includes positioning the sheath 601 within a portion of an organ, such as the left atrium 303 shown in Figure 3. As shown in block 704, method 700 includes moving one or both of the balloon wires 606 and 607 connected to the balloon 602 to move (i.e., adjust) the balloon along the sheath 601. For example, the balloon wires 606 and 607 may be used to adjust the position of the balloon 602 in opposite directions along the sheath 601.

[0043] As shown in block 706, method 700 includes inflating the balloon 602 once the target balloon position along the sheath 610 is obtained. As shown in block 708, method 700 includes fixing the balloon 602 to the target position along the sheath 601. For example, the projection wire 605 may be pulled until the folding element 604 (e.g., one or more folding projections 604a) engages with one or more opposing cavities 602a. Once one or more folding projections 604a engage with one or more opposing cavities 602a, the projection wire 605 is released and the balloon 602 is fixed (e.g., locked) to the target position on the sheath 601. Method 700 described above may be facilitated by using ultrasound, fluoroscopy, or other techniques known to those skilled in the art.

[0044] Figure 8A shows a portion of an exemplary tool 822 having a locking mechanism 804 according to one embodiment. As shown in Figure 8A, the tool 822 includes a sheath 801 having a sheath wall 803, an inflatable balloon 802, a locking mechanism wire 806, a first balloon wire 808, and a second balloon wire 809. The sheath 801 includes a corrugated element 810 having a corrugated projection 810a, as shown in Figures 8B and 8C, which is positioned on the sheath wall 803. The first balloon wire 808 includes a corrugated element 812 having a corrugated projection 812a, as shown in Figures 8B and 8C, which is opposite the corrugated element 810 positioned on the sheath wall 803. The second balloon wire 809 shown in Figure 8A does not include a corrugated element. Some embodiments include a second balloon wire 809 having a corrugated element. Embodiments may include any number of balloon wires, including a single balloon wire.

[0045] Figure 8B is an enlarged cross-sectional view of a portion of the sheath 801 and balloon 802 shown in Figure 8A, showing the locking mechanism 804 in the closed position. Figure 8C is an enlarged cross-sectional view of a portion of the sheath 801 and balloon 802 shown in Figure 8A, showing the locking mechanism 804 in the open position. The locking mechanism includes a locking mechanism wire 806 and a pivot arm 814. The pivot arm is configured to rotate about a pivot point 816. The pivot arm 814 is connected to the locking mechanism wire 806 at its pivot end (via a connecting mechanism (not shown)) and to the corrugated projection 810a at its balloon end via the balloon 802. In the open position shown in Figure 8C, the corrugated projection 812a on the sheath wall 803 is spaced apart from the opposing corrugated projection 810a on the balloon 802. However, in the closed position shown in Figure 8B, the corrugated projection 812a on the sheath wall 803 is moved to approach the opposing corrugated projection 810a on the balloon 802. For example, when the locking mechanism wire 806 is moved (pushed or pulled), the pivot arm 814 is rotated around the pivot point 816, thereby moving the pivot arm 814 between the positions shown in Figures 8B and 8C, and the corrugated projection 810a is moved between those positions shown in Figures 8B and 8C. In addition, unlike the projection 604a in the embodiments shown in Figures 6A and 6B, the corrugated projections 810a and 812a are not foldable.

[0046] Each of the protrusions 810a shown in Figures 8A to 8C is evenly spaced from one another. Each of the protrusions 812a shown in Figures 8A to 8C is also evenly spaced from one another. However, embodiments may include uneven spacing between the protrusions. The number and positions of the protrusions 810a and 812a shown in Figures 8A to 8C are illustrative. Embodiments may include any number of protrusions. Similar to Figures 6A and 6B, embodiments may include a balloon movement mechanism comprising any number of balloon wires for adjusting the position of the balloon 802 along the sheath 801.

[0047] After the tool 822 is positioned at the target location on the patient's organ (e.g., left atrium 103), the first balloon wire 808 is pulled, moving the balloon 802 along the sheath 801 in a proximal-distal direction (i.e., left-to-left direction in Figures 8A-8C). The corrugated projections 810a and 812a are separated from each other, as shown in their positions in Figure 8C, so that they can move in opposite directions (i.e., left-to-right direction) without contacting each other, allowing the balloon 802 to move to the target location. When balloon 802 reaches the target position along the sheath 801, the locking mechanism wire 806 is moved (e.g., pulled) to move the corrugated projection 810a and the opposing corrugated projection 812a closer to each other (i.e., vertically in Figures 8A-8C), until the locking mechanism 804 is closed, and the projections 810a and 812a reach their positions shown in Figure 8B, fixing (e.g., locking) balloon 802 to the target balloon position along the sheath 801.

[0048] Figure 9 shows a portion of a tool 922 according to one embodiment. As shown in Figure 9, the tool 922 includes a sheath 901 having a sheath wall 903, a balloon 902 covering the distal portion of the sheath 902, a pair of rings 904 and 905, a wire 906 positioned within the sheath wall 903, a catheter 907, and a saline tube 908. The rings 904 and 905 are positioned around the balloon 902 on each side of the balloon 902, spaced apart from each other, and configured to slide on the balloon 902. The distance between the two rings 904 and 905 is maintained by a fixing element (shown as a horizontal bar between the two rings 904 and 905 in Figure 9), allowing the rings 904 and 905 to move together distally and proximal (left-right in Figure 9) while maintaining an equidistant distance from each other. The balloon 902 has an inflatable portion 902a positioned between rings 904 and 905, and non-inflatable portions 902b and 902c positioned on the opposite side of rings 904 and 905. The inflatable portion 902a relies on the saltwater flow through the saltwater tube 908. Thus, the position and size of the non-inflatable portion 902a of the balloon 902 depend on the positions of rings 904 and 905, which isolate the saltwater flow that inflates the balloon 902 between rings 904 and 905. Similar to the embodiments described above, the balloon moving mechanism may include any number of balloon wires for adjusting the position of the balloon 902 to different positions along the sheath 901. The saltwater tube 908 enters the balloon 902 between rings 904 and 905 and is attached to the towing wire of the balloon 902 to inflate the inflatable portion 902a of the balloon 902 between rings 904 and 905 with saltwater.

[0049] After the tool 922 is positioned at the target location on the patient's organ (e.g., left atrium 103), the wire 906 is used to move the rings 904 and 905 along the balloon 902 to different positions along the sheath 901. As the balloon moves, the rings 904 and 905 may slide along the distal portion of the balloon covering of the sheath 901. Once the target positions of the rings 904 and 905 along the balloon 902 are obtained, the balloon 902 is fixed in place (e.g., locked) by inflating the inflatable portion 902a of the balloon 902, which is the portion between the rings 904 and 905, according to the adjusted positions of the rings 904 and 905.

[0050] This method can be implemented in a general-purpose computer, processor, or processor core. Suitable processors include, for example, general-purpose processors, dedicated processors, conventional processors, digital signal processors (DSPs), multiple microprocessors, one or more microprocessors associated with a DSP core, controllers, microcontrollers, application-specific integrated circuits (ASICs), field-programmable gate array (FPGA) circuits, any other type of integrated circuit (IC), and / or state machines. Such processors can be manufactured by configuring a manufacturing process using the results of processed hardware description language (HDL) instructions and other intermediate data such as netlists (such instructions can be stored in a computer-readable medium). The result of such processing may be a mask work, which is then used in a semiconductor manufacturing process to manufacture a processor that implements the features of this disclosure.

[0051] The methods or flowcharts provided herein can be implemented in computer programs, software, or firmware incorporated into non-temporary computer-readable storage media for implementation by a general-purpose computer or processor. Examples of non-temporary computer-readable storage media include read-only memory (ROM), random access memory (RAM), registers, cache memory, semiconductor memory devices, magnetic media such as internal hard disks and removable disks, magneto-optical media, and optical media such as CD-ROM discs and digital versatile disks (DVDs).

[0052] It should be understood that many modifications are possible based on the disclosures herein. Although features and elements are described above in specific combinations, each feature or element may be used alone without other features and elements, or in various combinations with or without other features and elements.

[0053] [Implementation Method] (1) A tool positioning method, Positioning a medical tool, which includes a sheath and an inflatable balloon connected to the sheath, at a target tool location within a portion of a patient's organs, The inflatable balloon is moved along the length of the sheath in the proximal-distal direction to the target balloon position. When the balloon is positioned at the target balloon position along the length of the sheath, the inflatable balloon is inflated, A tool positioning method comprising fixing the inflated balloon at the target balloon position along the length of the sheath to prevent the medical tool from moving away from the target tool position. (2) The method according to Embodiment 1, wherein moving the inflatable balloon involves rotating a rotatable handle connected to the inflatable balloon via at least one spring element, and by rotating the rotatable handle, the at least one spring element expands or contracts, moving the inflatable balloon in the proximal-distal direction. (3) Moving the inflatable balloon includes moving at least one balloon wire connected to the inflatable balloon, The method according to Embodiment 1, wherein fixing the inflated balloon to the target balloon position involves engaging at least one foldable projection located on one of the sheath and the inflatable balloon with at least one cavity located on the other of the sheath and the inflatable balloon. (4) Fixing the inflated balloon to the target balloon position, Pulling the projection wire until at least one of the foldable projections engages with the at least one cavity, The method according to Embodiment 3, further comprising releasing the projection wire when the at least one foldable projection engages with the at least one cavity. (5) Moving the inflatable balloon includes pulling at least one balloon wire connected to the inflatable balloon, The method according to Embodiment 1, wherein fixing the inflated balloon to the target position includes moving a scalloped projection located on the sheath toward an opposing scalloped projection located on the at least one balloon wire, and engaging it with the opposing scalloped projection.

[0054] (6) Moving the inflatable balloon includes pulling at least one balloon wire connected to the inflatable balloon, The method according to Embodiment 1, wherein fixing the inflated balloon to the target position involves inflating an inflatable portion of the inflatable balloon located between a pair of rings spaced apart from each other in the proximal-distal direction and arranged around the inflatable balloon, so that each of the opposing sides of the inflatable portion of the inflatable balloon contacts one of the pair of rings. (7) Medical tools for use in medical procedures, A sheath having a tube defined by a sheath wall, the sheath extending a certain length in the proximal-distal direction, An inflatable balloon connected to the aforementioned sheath, A balloon moving mechanism is connected to the inflatable balloon and configured to move the inflatable balloon to different balloon positions along the length of the sheath, A medical tool comprising: a balloon fixing mechanism configured to fix the inflatable balloon to a target balloon position along the length of the sheath when inflated, thereby preventing the medical tool from moving away from the target tool position within a portion of a patient's organs. (8) At least one spring element connected to the inflatable balloon and configured to expand and contract and move the inflatable balloon along the length of the sheath, A rotatable handle comprising a screw located within the rotatable handle and configured to rotate along the screw, The system further comprises at least one wire connected between the at least one spring element and the rotatable handle, The medical tool according to Embodiment 7, wherein rotation of the rotatable handle causes the at least one spring element to expand or contract, moving the inflatable balloon in the proximal-distal direction along the length of the sheath. (9) At least one balloon wire connected to the inflatable balloon, At least one foldable projection positioned on either the sheath or the inflatable balloon, The further comprising at least one cavity located above the other of the sheath and the inflatable balloon, The movement of the at least one balloon wire causes the inflatable balloon to move in the proximal-distal direction along the length of the sheath, The medical tool according to Embodiment 7, wherein the inflated balloon is fixed to the target balloon position when the at least one foldable projection engages with the at least one cavity. (10) The medical tool according to Embodiment 9, wherein the inflated balloon is fixed to the target balloon position by pulling a projection wire until the at least one foldable projection engages with the at least one cavity, and then releasing the projection wire once the at least one foldable projection engages with the at least one cavity.

[0055] (11) A plurality of first wave-shaped projections arranged on the sheath wall, A first balloon wire connected to the inflated balloon and having a plurality of second wave-shaped protrusions facing the plurality of first wave-shaped protrusions, A locking mechanism connected to at least one of the plurality of first wave-shaped protrusions and the plurality of second wave-shaped protrusions, The locking mechanism further comprises a locking wire connected to the locking mechanism, When the first balloon wire moves, the inflatable balloon moves, As the locking wire moves, the plurality of first wave-shaped protrusions and the plurality of second wave-shaped protrusions move toward each other and engage with each other, thereby fixing the inflated balloon to the target balloon position, according to Embodiment 7 of the medical tool. (12) A plurality of first wave-shaped projections arranged on the sheath wall, A first balloon wire connected to the inflated balloon and having a plurality of second wave-shaped protrusions facing the plurality of first wave-shaped protrusions, The device further comprises a locking mechanism connected to at least one of the plurality of first wave-shaped protrusions and the plurality of second wave-shaped protrusions, and configured to move between a first position and a second position. When the locking mechanism is in the first position, the plurality of first wave-shaped protrusions are separated from the plurality of second wave-shaped protrusions, thereby allowing the inflatable balloon to move in the proximal-distal direction. The medical tool according to Embodiment 7, wherein when the locking mechanism is in the second position, the plurality of first wave-shaped projections and the plurality of second wave-shaped projections are configured to engage with each other and prevent the inflated balloon from moving in the proximal-distal direction. (13) The inflatable balloon is positioned around the sheath and comprises an inflatable portion and a non-inflatable portion, and the medical tool is At least one balloon wire connected to the inflatable balloon, The inflatable balloon is further comprising a pair of rings arranged around it and spaced apart from each other in the proximal-distal direction, The medical tool according to embodiment 7, wherein when the inflatable balloon is inflated, one of each of the opposing sides of the inflated portion of the inflatable balloon contacts one of the pair of rings, thereby fixing the inflated balloon to the target balloon position. (14) A tool positioning system for use in medical procedures, A medical tool configured to navigate to a target tool location within a portion of a patient's organs, A sheath having a tube defined by a sheath wall, the sheath extending a certain length in the proximal-distal direction, A medical tool comprising: an inflatable balloon connected to the sheath and configured to move along the length of the sheath in the proximal-distal direction, wherein 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; A memory configured to store positional data corresponding to acquired positional signals, indicating the position of the tool in a three-dimensional (3D) space including the organs of the patient, A tool positioning system comprising: at least one processor configured to generate mapping information for displaying the position of the tool in the 3D space from the position data. (15) The medical tool At least one spring element connected to the inflatable balloon and configured to expand and contract, and to move the inflatable balloon along the length of the sheath, A rotatable handle comprising a screw located within the rotatable handle and configured to rotate along the screw, The system further comprises at least one wire connected between the at least one spring element and the rotatable handle, The tool positioning system according to embodiment 14, wherein rotation of the rotatable handle causes at least one spring element to expand or contract, moving the inflatable balloon in the proximal-distal direction along the length of the sheath.

[0056] (16) The medical tool said to be At least one balloon wire connected to the inflatable balloon, At least one foldable projection positioned on either the sheath or the inflatable balloon, The further comprising at least one cavity located above the other of the sheath and the inflatable balloon, The movement of the at least one balloon wire causes the inflatable balloon to move in the proximal-distal direction along the length of the sheath, The tool positioning system according to embodiment 14, wherein the inflated balloon is fixed to the target balloon position when the at least one foldable projection engages with the at least one cavity. (17) The tool positioning system according to Embodiment 16, wherein the inflated balloon is fixed to the target balloon position by pulling a projection wire until the at least one foldable projection engages with the at least one cavity, and then releasing the projection wire once the at least one foldable projection engages with the at least one cavity. (18) The medical tool said to be A plurality of first wave-shaped protrusions arranged on the sheath wall, A first balloon wire connected to the inflated balloon, having a plurality of second wave-shaped protrusions facing the plurality of first wave-shaped protrusions, A locking mechanism connected to at least one of the plurality of first wave-shaped protrusions and the plurality of second wave-shaped protrusions, The locking mechanism further comprises a locking wire connected to the locking mechanism, When the first balloon wire moves, the inflatable balloon moves, The tool positioning system according to Embodiment 14, wherein when the lock wire moves, the plurality of first wave-shaped protrusions and the plurality of second wave-shaped protrusions move toward each other, engage with each other, and fix the inflated balloon in the target balloon position. (19) The medical tool said to be A plurality of first wave-shaped protrusions arranged on the sheath wall, A first balloon wire connected to the inflated balloon, having a plurality of second wave-shaped protrusions facing the plurality of first wave-shaped protrusions, The device further comprises a locking mechanism connected to at least one of the plurality of first wave-shaped protrusions and the plurality of second wave-shaped protrusions, and configured to move between a first position and a second position. When the locking mechanism is in the first position, the plurality of first wave-shaped protrusions are separated from the plurality of second wave-shaped protrusions, thereby allowing the inflatable balloon to move in the proximal-distal direction. The tool positioning system according to embodiment 14, wherein when the locking mechanism is in the second position, the plurality of first wave-shaped protrusions and the plurality of second wave-shaped protrusions are configured to engage with each other and prevent the inflated balloon from moving in the proximal-distal direction. (20) The inflatable balloon is positioned around the sheath and comprises an inflatable portion and a non-inflatable portion, and the medical tool is At least one balloon wire connected to the inflatable balloon, The inflatable balloon is further comprising a pair of rings arranged around it and spaced apart from each other in the proximal-distal direction, The tool positioning system according to embodiment 14, wherein when the inflatable balloon is inflated, one of each of the opposing sides of the inflated portion of the inflatable balloon contacts one of the pair of rings, thereby fixing the inflated balloon to the target balloon position.

Claims

[Claim 1] A medical tool used in medical procedures, A sheath having a tube defined by a sheath wall, the sheath extending a certain length in the proximal-distal direction, An inflatable balloon connected to the aforementioned sheath, A balloon moving mechanism is connected to the inflatable balloon and configured to move the inflatable balloon to different balloon positions along the length of the sheath, A medical tool comprising: a balloon fixing mechanism configured to fix the inflatable balloon to a target balloon position along the length of the sheath when inflated, thereby preventing the medical tool from moving away from the target tool position within a portion of a patient's organs.

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