Patent ID: 12186502

DETAILED DESCRIPTION

A sheath may be used in intravascular, intracardiac or any intraluminal invasive medical procedures. For example, a sheath may be a tool, or part of a tool, of an electromagnetic navigation system used to determine the location of the sheath in a 3-D space during a medical procedure. This sheath allows devices (such as catheters, guide wires and needles, etc.) to pass through the sheath as well as suctioning in specific locations of a patient's anatomy. The sheath facilitates navigation through the patient's anatomy, curving the devices passing through it in a determined direction and maintaining desired balance between rigidity and flexibility (and force in some cases) to direct, stabilize and use the devices in specific locations in the body of the patient.

When positioning the sheath at a target location of a patient (e.g., in a heart) during a medical procedure, the sheath typically passes through a puncture hole or an existing fossa (i.e. a trans-septal puncture). During the procedure the location of the sheath serves as an access point to the target location.

In some situations, after the sheath is positioned at a target location, the sheath may move (e.g., slips) from its target location, requiring regaining access to the target location and/or repositioning of the sheath. For example, when the sheath is positioned (e.g., by a cardiac physician) into the right atrium, the sheath enters the left atrium through the fossa ovalis in the septum. The fossa ovalis is a depression in the tissue of the septum, which is used as a marker to indicate to the physician a location where 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 can slip back into the right atrium, causing a loss of access to the sheath. Regaining access to the sheath and/or repositioning of the sheath, however, is time consuming and poses additional risk for the patient (e.g., risk of injury).

Embodiments disclosed herein provide an apparatus and method of using a medical tool with an inflatable balloon to position a portion (e.g., a sheath) of the medical tool at a target tool location (e.g., location suitable for organ size and anatomy) inside an organ (e.g., the left atrium) of a patient's anatomy and securing 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.

Embodiments disclosed herein provide systems, tools and methods for adjusting the location of a balloon on a tool (e.g., on the sheath of the tool) and fixing (e.g., locking) the inflatable balloon at the location on the tool.

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

FIG.1is an illustration of an example medical system20which may be used to generate and display information52(e.g., a chart, anatomical models of a portion of a patient and signal information). The system20and the tool22shown inFIG.1are merely by example. Medical tools, such as tool22, can be any tool used for diagnostic or therapeutic treatment, such as for mapping electrical potentials in a heart26of a patient28. Alternatively, tools may be used, mutatis mutandis, for other therapeutic and/or diagnostic purposes of different portions of 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.

An operator30may insert the tool22into a portion of patient anatomy, such as the vascular system of the patient28so that a tip56of the tool22enters a chamber of the heart26. The control console24may use magnetic position sensing to determine 3-D position coordinates of the tool (e.g., coordinates of the tip56) inside the heart26. To determine the position coordinates, a driver circuit34in the control console24may drive, via connector,44, field generators36to generate magnetic fields within the anatomy of the patient28.

The field generators36include one or more emitter coils (not shown inFIG.1), placed at known positions external to the patient28, which are configured to generate magnetic fields in a predefined working volume that contains a portion of interest of the patient anatomy. Each of the emitting coils may be driven by a different frequency to emit a constant magnetic field. For example, in the example medical system20shown inFIG.1, one or more emitter coils can be placed below the torso of the patient28and each configured to generate magnetic fields in a predefined working volume that contains the heart26of the patient.

As shown inFIG.1, a magnetic field location sensor38is disposed at the tip56of tool22. The magnetic field location sensor38generates electrical signals, based on the amplitude and phase of the magnetic fields, indicating the 3-D position coordinates of the tool (e.g., position coordinates of the tip56). The electrical signals may be communicated to the control console24to determine the position coordinates of the tool. The electrical signals may be communicated to the control console24via wire45.

Alternatively, or in addition to wired communication, the electrical signals may be wirelessly communicated to the control console24, for example, via a wireless communication interface (not shown) at the tool22that may communicate with input/output (I/O) interface42in the control console24. For example, U.S. Pat. No. 6,266,551, whose disclosure is incorporated herein by reference, describes, inter alia, a wireless catheter, which is not physically connected to signal processing and/or computing apparatus and is incorporated herein by reference. Rather, a transmitter/receiver is attached to the proximal end of the catheter. The transmitter/receiver communicates with a signal processing and/or computer apparatus using wireless communication methods, such as IR, RF, Bluetooth, or acoustic transmissions. The wireless digital interface and the I/O interface42may operate in accordance with any suitable wireless communication standard that is known in the art, such as for example, IR, RF, Bluetooth, one of the IEEE 802.11 family of standards (e.g., Wi-Fi), or the HiperLAN standard.

AlthoughFIG.1shows a single magnetic field location sensor38disposed at the tip56of tool22, tools may include one or more magnetic field location sensors each disposed at any tool portion. The magnetic field location sensor38may include one or more miniature coils (not shown). For example, a magnetic field location sensor may include multiple miniature coils oriented along different axes. Alternatively, the magnetic field location sensor may comprise either another type of magnetic sensor or position transducers of other types, such as impedance-based or ultrasonic location sensors.

The signal processor40is configured to process the signals to determine the position coordinates of the tool22, including both location and orientation coordinates. The method of position sensing described hereinabove is implemented in the CARTO mapping system produced by Biosense Webster Inc., of Diamond Bar, Calif., and is described in detail in the patents and the patent applications cited herein.

The tool22may also include a force sensor54contained within the distal end32. The force sensor54may measure a force applied by the tool22(e.g., the tip56of the tool) to the endocardial tissue of the heart26and generate a signal that is sent to the control console24. The force sensor54may include a magnetic field transmitter and a receiver connected by a spring in the distal end32, and may generate an indication of the force based on measuring a deflection of the spring. Further details of this sort of probe and force sensor are described in U.S. Patent Application Publication No. 2009/0093806, published Apr. 9, 2009, issued as U.S. Pat. No. 8,357,152 on Jan. 22, 2013, and U.S. Patent Application Publication No. 2009/0138007, published May 28, 2009, issued as U.S. Pat. No. 8,535,308 on Sep. 17, 2013, whose disclosures are incorporated herein by reference. Alternatively, the distal end32may include another type of force sensor that may use, for example, fiber optics or impedance measurements.

The tool22may also include an electrode48coupled to the tip56and configured to function as an impedance-based position transducer. Additionally, or alternatively, the electrode48may be configured to measure a certain physiological property, for example the local surface electrical potential (e.g., of cardiac tissue) at one or more locations. The electrode48may be configured to apply RF energy to ablate endocardial tissue in the heart26.

Although the example medical system20may be configured to measure the position of the tool22using magnetic-based sensors, other position tracking techniques may be used (e.g., impedance-based sensors). Magnetic position tracking techniques are described, for example, in U.S. Pat. Nos. 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. Pat. Nos. 5,983,126, 6,456,828 and 5,944,022, the disclosures of which are incorporated herein by reference.

The I/O interface42may enable the control console24to interact with the tool22, the body surface electrodes46and any other sensors (not shown). Based on the electrical impulses received from the body surface electrodes46and the electrical signals received from the tool22via the I/O interface42and other components of medical system20, the signal processor40may determine the location of the tool in a 3-D space and generate the display information52, which may be shown on a display50.

The signal processor40may be included in a general-purpose computer, with a suitable front end and interface circuits for receiving signals from the tool22and controlling the other components of the control console24. The signal processor40may be programmed, using software, to perform the functions that are described herein. The software may be downloaded to the control console24in electronic form, over a network, for example, or it may be provided on non-transitory tangible media, such as optical, magnetic or electronic memory media. Alternatively, some or all of the functions of the signal processor40may be performed by dedicated or programmable digital hardware components.

In the example shown atFIG.1, the control console24is connected, via cable44, to body surface electrodes46, each of which are attached to patient28using patches (e.g., indicated inFIG.1as circles around the electrodes46) that adhere to the skin of the patient. Body surface electrodes46may 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) enabling local digital signal processing, a radio link, and a miniaturized rechargeable battery. In addition or alternative to the patches, body surface electrodes46may also be positioned on the patient using articles worn by patient28which include the body surface electrodes46and may also include one or more position sensors (not shown) indicating the location of the worn article. For example, body surface electrodes46can be embedded in an article (e.g., a vest) disposed on the patient28. During operation, the body surface electrodes46assist in providing a location of the tool (e.g., tool including an inflatable balloon) in 3-D space by detecting electrical impulses generated by the polarization and depolarization of cardiac tissue and transmitting information to the control console24, via the cable44. The body surface electrodes46can be equipped with magnetic location tracking and can help identify and track the respiration cycle of the patient28. In addition to or alternative to wired communication, the body surface electrodes46may communicate with the control console24and one another via a wireless interface (not shown).

During the diagnostic treatment, the signal processor40may present the display information52and may store data representing the information52in a memory58. The memory58may include any suitable volatile and/or non-volatile memory, such as random access memory or a hard disk drive. The operator30may be able to manipulate the display information52using one or more input devices59. Alternatively, the medical system20may include a second operator that manipulates the control console24while the operator30manipulates the tool22. It should be noted that the configuration shown inFIG.1is exemplary. Any suitable configuration of the medical system20may be used and implemented.

FIG.2is a block diagram illustrating example components of a medical system200for use with embodiments described herein. As shown inFIG.2, the system200includes medical tool222, processing device204, display device206and memory212. The processing device204, display device206and memory212are a part of computing device214. In some embodiments, the display device206may be separate from computing device214. Computing device214may also include an I/O interface, such as I/O interface42shown inFIG.1

Tool222includes an array of electrodes208each configured to detect electrical activity (electrical signals) of an area of an organ (e.g., a heart) over time. When an ECG is performed, each electrode detects the electrical activity of an area of the organ in contact with the electrode. Tool222also includes a plurality of sensors208. The sensors208include, for example, a magnetic field location sensor (e.g., sensor38inFIG.1) for providing location signals to indicate the 3-D position coordinates of the tool222. In some procedures, one or more additional sensors210that are separate from the tool222, as shown in example system200, are also used to provide location signals. Additional sensors210may also include sensors (e.g., electrodes on the skin of a patient) used to assist with detection of electrical activity of an organ via detection of electrical changes on the skin due to the electro-physiologic pattern of the organ, such as the heart. Tool222also includes an inflatable balloon202, which may be adjusted and inflated at a target location in the organ of the patient to secure the tool222at the target location by preventing or limiting movement of the tool222at the target location, as described in more detail below.

Processing device204may include one or more processors each configured to process the ECG signals, record ECG signals over time, filter ECG signals, fractionate ECG signals into signal components (e.g., slopes, waves, complexes) and generate and combine ECG signal information for displaying the plurality of electrical signals on display device206. Processing device204may also generate and interpolate mapping information for displaying 3D maps of the heart on display device206. Processing device204may include one or more processors (e.g., signal processor40) configured to process the location information acquired from sensors (e.g., additional sensors210and sensors216) to determine the position coordinates of the tool222, including both location and orientation coordinates.

In addition, processing device204determines locations of anatomical regions of an organ (e.g., the heart) on the map, determines which electrical signals correspond to areas of the organ that are located within the anatomical regions of the organ and generate signal information (e.g., correlated ECG information) for displaying electrical signals determined to correspond to the areas of the organ that are located within the anatomical regions of the organ (i.e., determined to be the electrical signals acquired by electrodes (i.e., poles) disposed at the corresponding areas of the organ). Processing device204drives display device206to display dynamic maps (i.e., spatio-temporal maps) of the organ and the electrical activity of the organ using the mapping information and the signal information. Processing device204also drives display device206to display the signals determined to be located within the anatomical region of the organ using the correlated signal information.

Display device206may include one or more displays each configured to display 3D maps of the organ representing spatio-temporal manifestations of the electrical activity of the organ over time and display the electrical signals acquired from the organ over time. For example, a 3D map of the organ representing the electrical activity of the organ for a specific time interval and the electrical signals acquired from the organ during the time interval may be displayed concurrently 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.

The electrodes208, sensor(s)216and additional sensor(s)210may be in wired or wireless communication with processing device204. Display device206may also be in wired or wireless communication with processing device204.

FIG.3is an illustration of an example medical tool, positioned within a portion of a heart, for use with embodiments described herein. In the example shown inFIG.3, the medical tool322comprises a sheath301(comprising a shaft or tube) and an inflatable balloon302coupled (e.g., directly or indirectly connected) to the sheath301.FIG.3illustrates the sheath301and the balloon302positioned in the left atrium303of the heart after having entered the left atrium303from the right atrium304. The balloon302is shown in an inflated state inside the left atrium303, providing stability by preventing the sheath301from moving (e.g., slipping back) into the right atrium304.

Although the tool322is shown in a heart inFIG.3, the use of the tool322in a heart is an example. The tool322may be used in other organs and other portions of a patient's anatomy. The location of the balloon302around the shaft of the sheath301shown inFIG.3is also an example. The balloon302is adjustable to different locations around the shaft of the sheath301, suitable for different procedures, users and anatomies as well as sheath and catheter maneuvering strategies.

FIG.4is a diagram illustrating components of tool422according to an embodiment. The tool422includes a sheath401and a rotatable handle406coupled to the sheath via wires407. The sheath401includes an inflatable balloon402and spring elements403, coupled to the balloon402in a wall of the sheath401and coupled to the wires407. Spring elements403are configured to expand and contract to adjust the balloon402to different locations along the sheath401. Each spring element403may include a helical spring. Spring elements may also include other types of spring-like mechanisms configured to adjust the balloon402to different locations along the sheath401. In addition, sheaths may include any number of spring elements, including a single spring element, to adjust the balloon402to different locations along the sheath401. Tools may include any number of wires, including a single wire, to adjust the balloon402to different locations along the sheath401.

Rotatable handle406includes a screw element404disposed within the rotatable handle406. The screw element404may, for example, be a screw having threads which are configured to rotatably engage with opposable threads of the sheath. Spring element403, rotatable handle406, screw element404, and wires407together form a balloon moving mechanism, used to move the balloon402to different locations along the sheath401. For example, the rotatable handle406is rotated about the screw element404to exert a force (e.g., push force or pull force depending on the rotational direction of the rotatable handle406) on the wires407, which causes the spring elements403, which are coupled to the wires407, to expand or contract. The expanding and contracting of the spring elements403causes the balloon402, which are coupled to the spring elements403, to move in opposing directions along the sheath401.

FIG.5is a flow diagram illustrating an example method500of positioning and securing a portion of the tool422shown inFIG.4at a target tool location within a patient's anatomy according to an embodiment. As shown at block502, the method500includes positioning the tool422(e.g., the sheath401of the tool422) within a portion of an organ, such as the left atrium303shown inFIG.3. As shown at block504, the method500includes rotating the rotatable handle406to move (i.e., adjust) the balloon402to a target balloon location along the sheath401. For example, the rotatable handle406is rotated (e.g., by a physician) about the screw element404, causing spring element403to expand or contract via wires407. The expansion of the spring element403causes the balloon402to move in one direction along the sheath401and the contraction of the spring element403causes the balloon402to move in an opposite direction along the sheath401.

When the balloon reaches the target balloon location along the sheath401, rotation of the rotatable handle406stops and the balloon402is inflated, as shown at block506. The inflated balloon502is then fixed at the target balloon location along the sheath501as shown at block508. The balloon402is fixed at the target balloon location, for example, by locking the balloon402at the target balloon location using a locking mechanism, such as those described herein. Accordingly, the sheath401is prevented from moving from the target tool location to another location within the patient's anatomy (e.g., prevented from slipping out of the left atrium303). The method500described above may be facilitated using ultrasound, fluoroscopic imaging, or other techniques known to those skilled in the art.

FIG.6Ais a diagram illustrating components of a tool622according to an embodiment. As shown inFIG.6A, the tool622includes a sheath601having a sheath wall603, a balloon602, a collapsible element604, a protrusion wire605, a first balloon wire606and a second balloon wire607.

The first balloon wire and the second balloon wire are string-like elements that can be moved (pulled and released) to facilitate the positioning of the sheath601shown inFIG.6Aat a target tool location of a patient (e.g., target location within the left atrium of the heart). The balloon wires606and607together form a balloon moving mechanism, which are used to adjust the location of the balloon602along the length of the sheath's shaft while the protrusion wire605is used to fix (e.g., lock) the balloon602at a target location along the sheath601. For example, the first balloon wire606may be used to move the balloon602in a direction along the sheath601from a proximal side of the sheath601to a distal side (closer to the tip) of the sheath601. The second balloon wire306may be used to move the balloon602in the opposite direction along the sheath601from a distal side of the sheath601to a proximal side of the sheath601. The number of balloon wires shown inFIG.6Ais merely exemplary. Balloon moving mechanisms may comprise any number of balloon wires to adjust the location of the balloon602along the sheath601.

FIG.6Bis an illustration showing examples collapsible protrusions in collapsed positions and engaged positions relative to cavities602adisposed on a inner side608of balloon602. The collapsible protrusions604aand604bare examples of a collapsible element604shown inFIG.6A. As shown inFIG.6B, collapsible protrusions604aand604b(e.g., tooth shaped protrusions) disposed on the sheath wall603. Collapsible protrusions604aare shown in their collapsed positions. Collapsible protrusion604bis shown in an engaged (i.e., extended) position. The balloon602includes cavities602adisposed on an inner side608of the balloon602, which engage and disengage from the collapsible protrusions604aand604bdisposed on the sheath wall603to adjust the balloon602to different locations along the length of the sheath601and prevent (e.g., lock) the balloon602from moving along the length of the sheath601. The number of protrusions604aand cavities602aand their locations shown inFIG.6Bis merely exemplary. In another embodiment, cavities disposed on the sheath wall may engage collapsible protrusions disposed on the inner side of the balloon.

For example, when a target location of the balloon is obtained along the proximal-distal direction, the balloon102is inflated and the protrusion wire605is pulled to cause the protrusions604aand604bto move to their engaged positions until the collapsible protrusions604aand604balign with and engage the cavities602aof the balloon602. When the protrusions604aand604bengage with the cavities602a, the protrusion wire605is released and the balloon602is fixed at or locked at the target location. The collapsible protrusions604aand604bmay also be aligned with the cavities602aby rotating the sheath601in the directions shown by the arrows610inFIG.6A.

FIG.7is a flow diagram illustrating an example method700of securing the sheath601shown inFIG.6Aat a target tool location within a patient's anatomy according to an embodiment. As shown at block702, the method700includes positioning the sheath601within a portion of an organ, such as the left atrium303shown inFIG.3. As shown at block704, the method700includes moving one or both of the balloon wires606and607, which are coupled to the balloon602, to move (i.e., adjust) the balloon along the sheath601. For example, balloon wires606and607may be used to adjust the location of the balloon602in opposing directions along the sheath601.

As shown at block706, the method700includes inflating the balloon602when the target balloon location along the sheath610is obtained. As shown at block708, the method700includes fixing the balloon602at the target location along the sheath601. For example, the protrusion wire605may be pulled until the collapsible element604(e.g., one or more collapsible protrusions604a) are engaged with one or more opposing cavities602a. When one or more collapsible protrusions604aare engaged with one or more opposing cavities602a, the protrusion wire605is released and the balloon602is fixed (e.g., locked) at the target location on the sheath601. The method700described above may be facilitated using ultrasound, fluoroscopic imaging, or other techniques known to those skilled in the art.

FIG.8Ashows a portion of an example tool822having a locking mechanism804according to one embodiment. As shown inFIG.8A, tool822includes sheath801having a sheath wall803, an inflatable balloon802, a locking mechanism wire806, a first balloon wire808and a second balloon wire809. The sheath801includes a scalloped element810, comprising scalloped protrusions810ashown inFIGS.8B and8C, disposed on the sheath wall803. The first balloon wire808includes a scalloped element812, comprising scalloped protrusions812ashown inFIGS.8B and8C, opposing the scalloped element810disposed on the sheath wall803. The second balloon wire809shown inFIG.8Adoes not include a scalloped element. Some embodiments include a second balloon wire809having a scalloped element. Embodiments may include any number of balloon wires, including a single balloon wire.

FIG.8Bis an expanded, cross-sectional view of a portion of the sheath801shown inFIG.8Aand the balloon802illustrating the locking mechanism804in a closed position.FIG.8Cis an expanded, cross-sectional view of a portion of the sheath801shown inFIG.8Aand the balloon802illustrating the locking mechanism804in an open position. The locking mechanism includes a locking mechanism wire806and a pivoting arm814. The pivoting arm is configured to pivot about a pivot point816. The pivoting arm814is coupled to the locking mechanism wire806at a pivoting end (via a linkage, which is not shown) and the scalloped protrusions810a, via the balloon802, at a balloon end. In the open position shown inFIG.8C, the scalloped protrusions812aon the sheath wall803are spaced from the opposing scalloped protrusions810aon the balloon802. In the closed position shown inFIG.8B, however, the scalloped protrusions812aon the sheath wall803are moved closer to the opposing scalloped protrusions810aon the balloon802. For example, when the locking mechanism wire806is moved (pushed or pulled), pivoting arm814is caused to pivot about pivot point816such that pivoting arm814moves between locations shown inFIGS.8B and8Cand the scalloped protrusions810aare caused to move between their positions shown inFIGS.8B and8C. In addition, unlike the protrusions604ain the embodiment shown inFIGS.6A and6B, the scalloped protrusions810aand812aare not collapsible.

Each of the protrusions810ashown inFIGS.8A-8Care spaced equally from each other. Each of the protrusions812ashown inFIGS.8A-8Care also spaced equally from each other. Embodiments may, however, include unequal spaces between the protrusions. The number and location of the protrusions810aand812ashown inFIGS.8A-8Care exemplary. Embodiments may include any number of protrusions. Similar toFIGS.6A and6B, embodiments may include a balloon moving mechanism which comprises any number of balloon wires to adjust the location of the balloon802along the sheath801.

After the tool822is positioned at a target location of an organ (e.g., the left atrium103) of the patient, the first balloon wire808is pulled, causing the balloon802to move along the sheath in a proximal-distal direction (i.e, in a left-right direction inFIGS.8A-8C) along the sheath801. The scalloped protrusions810aand scalloped protrusions812a, as shown in their positions inFIG.8C, are separated from each other such that they are able to move in opposite directions (i.e., left and right directions) without contacting each other, enabling the balloon802to move to the target location. When the balloon802reaches the target location along the sheath801, the locking mechanism wire806is moved (e.g., pulled), causing the scalloped protrusions810aand opposing scalloped protrusions812ato move closer to each other (i.e., in an up-down direction inFIGS.8A-8C) until the locking mechanism804is closed and protrusions810aand812areach their positions shown inFIG.8B, and fix (e.g., lock) the balloon802at the target balloon location along the sheath801.

FIG.9shows a portion of tool922according to an embodiment. As shown inFIG.9, the tool922includes a sheath901having a sheath wall903, a balloon902covering a distal part of the sheath902, a pair of rings904and905, a wire906disposed within the sheath wall903, a catheter907and a saline tube908. The rings904and905are disposed around the balloon902on each side of the balloon902, are spaced from each other and configured to slide on the balloon902. The distance between the two rings904and905is maintained by a fixed element (shown as horizontal bar between the two rings904and905inFIG.9), allowing the rings904and905to move together distally and proximally (left-right directions inFIG.9) while maintaining an equal distance from each other. The balloon902has an inflatable part902adisposed between the rings904and905and non-inflatable portions902band902cdisposed on opposite side of the rings904and905. The inflatable part902ais dependent on the saline flow via the saline tube908. Accordingly, the location and size of the inflatable part902aof the balloon902depends on the location of the rings904and905which quarantine the saline flow causing the balloon902to inflate between the rings904and905. Similar to the embodiments described above, a balloon moving mechanism may comprise any number of balloon wires to adjust the location of the balloon902to different locations along the sheath901. The saline tube908enters the balloon902between rings904and905and is attached to the puller wire of the balloon902to inflate the inflatable portion902aof the balloon902between the rings904and905with saline.

After the tool922is positioned at a target location of an organ (e.g., the left atrium103) of the patient, the wire906is used to move the rings904and905along the balloon902to different locations along the sheath901. When the balloon is moved, the rings904and905may slide along the balloon covered distal part of the sheath901. When the target location of rings904and905along the balloon902is obtained, the balloon902is fixed (e.g., locked) into place by inflating the inflatable part902aof the balloon902, which is the part between rings904and905depending on the location of the rings904and905after adjustment.

The methods provided can be implemented in a general purpose computer, a processor, or a processor core. Suitable processors include, by way of example, a general purpose processor, a special purpose processor, a conventional processor, a digital signal processor (DSP), a plurality of microprocessors, one or more microprocessors in association with a DSP core, a controller, a microcontroller, Application Specific Integrated Circuits (ASICs), Field Programmable Gate Arrays (FPGAs) circuits, any other type of integrated circuit (IC), and/or a state machine. Such processors can be manufactured by configuring a manufacturing process using the results of processed hardware description language (HDL) instructions and other intermediary data including netlists (such instructions capable of being stored on a computer readable media). The results of such processing can be maskworks that are then used in a semiconductor manufacturing process to manufacture a processor which implements features of the disclosure.

The methods or flow charts provided herein can be implemented in a computer program, software, or firmware incorporated in a non-transitory computer-readable storage medium for execution by a general purpose computer or a processor. Examples of non-transitory computer-readable storage mediums include a read only memory (ROM), a random access memory (RAM), a register, 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 disks, and digital versatile disks (DVDs).

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 can be used alone without the other features and elements or in various combinations with or without other features and elements.