Patent Description:
Balloon catheters may be used in various medical procedures, such as in cardiac ablation. The balloon catheter is typically controlled remotely by a physician. Method and devices for controlling the operation of balloon catheters are known in the art.

For example, <CIT> describes a medical device for the treatment and irrigation of a sinus opening is described. The device allows for single-handed operation to access, dilate and irrigate a sinus opening. The device includes a sinus guide catheter, a guiding element, a balloon dilation catheter, a balloon catheter movement mechanism and a guiding element movement mechanism.

<CIT> describes a steerable ablation catheter system suitable for radiofrequency ablation of intra-cardiac tissue that comprises two parts: a disposable catheter shaft with a deflectable tip at the distal end of the shaft, and a handle with steering mechanisms.

<CIT> describes a delivery device for a stented prosthetic heart valve.

An embodiment of the present invention that is described herein provides a medical instrument according to claim <NUM>.

In some embodiments, the first knob is configured to apply first and second levels of deflection of the medical device relative to the longitudinal axis of the medical instrument by being set at respective selected first and second positions along the longitudinal axis of the medical instrument. In other embodiments, the second knob is configured to set the medical device to first and second shapes by being set at respective selected first and second positions along the longitudinal axis of the medical instrument. In yet other embodiments, the first and second knobs are configured to operate independently of one another.

In an embodiment, at least one of the first and second knobs is movable, within a continuous range, along the longitudinal axis. In another embodiment, the handle includes a grip located in proximity to the first and second knobs, such that both the first and second knobs are accessible by one or more fingers of an operator hand that holds the grip. In yet another embodiment, the medical device is configured to be applied in a medical procedure selected from a list consisting of electrophysiology, ablation, sinuplasty, surgery, endoscopy, angioplasty, otolaryngology and neurology.

In some embodiments, the medical device includes an inflatable balloon catheter having an internal volume configured to receive inflation fluid. In other embodiments, the second knob is configured, when moved in a first direction along the longitudinal axis, to allow an inflation of the internal volume of the balloon catheter, and when moved in a second direction along the longitudinal axis, to deflate the balloon catheter by elongating the balloon and forcing the inflation fluid out of the internal volume. In yet other embodiments, the inflatable balloon catheter includes one or more electrodes coupled to an outer surface of the inflatable balloon catheter.

In an embodiment of the present invention, the medical device includes at least one of electrodes and sensors coupled to the medical device at predefined positions, and at least one of the first and second knobs includes one or more markers indicative of the respective positions of the at least one of electrodes and sensors. In another embodiment, each of the one or more markers includes a respective number of an electrode or a sensor of the at least one of electrodes and sensors.

There is additionally provided, in accordance with an example of the present disclosure that is not claimed, a method including inserting a medical device coupled to a distal end of a medical instrument into a patient organ. A deflection of the medical device, relative to a longitudinal axis of the medical instrument, is controlled by moving a first knob, which is fitted on a handle of the medical instrument, along the longitudinal axis. A shape of the medical device is controlled by moving a second knob, which is fitted on the handle of the medical instrument, along the longitudinal axis of the medical instrument. A medical procedure is conducted in the patient organ using the medical device.

Catheters are used, for example, in various interventional cardiology procedures, such as in treating arrhythmia, by ablating the heart tissue so as to form a lesion that blocks electrical conduction along a path of the heart tissue. A catheter used for ablation may comprise an inflatable balloon assembly having an array of devices, such as ablation electrodes, mounted on an outer surface of the balloon assembly. A catheter of this sort is referred to herein as a balloon catheter.

Embodiments of the present invention that are described hereinbelow provide improved techniques for controlling the operations of inflation and deflection of a balloon catheter.

During an ablation procedure, a physician typically starts with a deflated balloon for navigating the catheter to a target location in a patient heart. At the target location, the physician inflates the balloon so as to make physical contact between at least some of the ablation electrodes and heart tissue at the target location. In some cases, the physician may have to deflect the balloon assembly relative to the longitudinal axis of the catheter, so as to better reach the target tissue and/or improve the physical contact with the tissue.

In some embodiments, the catheter comprises a handle, which is coupled to the catheter proximal end, and which is configured to control the balloon assembly at the catheter distal end. At least first and second knobs are fitted on the handle and are movable along the longitudinal axis of the catheter. The first knob is configured to control a deflection of the balloon assembly relative to the longitudinal axis, and the second knob is configured to control the shape of the balloon catheter by elongating the balloon, thus collapsing it and forcing out inflation fluid through existing holes in the balloon. In some embodiments, the first and second knobs are configured to operate independently of one another, such that the physician may inflate or deflate the balloon assembly before or after deflecting the distal end of the catheter, or in any other suitable operational sequence.

In some embodiments, the level of inflation of the balloon assembly and the level of deflection of the distal end are each controllable in a continuous manner. In an exemplary sequence, the physician may deflect the distal end to its maximal deflection level after inflating a portion (e.g., half) of the internal volume of the balloon assembly, and subsequently, the physician inflates the balloon assembly to a fully inflated position.

The disclosed techniques improve the patient safety by providing the physician with easy control of the inflation and deflection operations of the balloon catheter using a single finger. When using the disclosed techniques, the physician can focus his or her attention on the essence of the procedure rather than on the technical manipulation of the balloon catheter.

Furthermore, the disclosed techniques may increase the success rate of ablation procedures by enabling accurate positioning of the ablation electrodes at the target locations of the tissue.

<FIG> is a schematic, pictorial illustration of a catheterization system <NUM>, in accordance with an embodiment of the present Invention. System <NUM> comprises a medical instrument, such as a balloon catheter <NUM>, and a control console <NUM>. In the embodiment described herein, catheter <NUM> may be used for any suitable therapeutic and/or diagnostic purposes, such as for ablating tissue or sensing electrophysiological (EP) signals from a heart <NUM> of a patient <NUM>.

In some embodiments, console <NUM> comprises a processor <NUM> having suitable front end and interface circuits for receiving signals from catheter <NUM>, and for controlling other components of system <NUM>.

In some embodiments, processor <NUM> typically comprises a general-purpose processor, which is programmed in software to carry out the functions described herein. The software may be downloaded to the computer in electronic form, over a network, for example, or it may, alternatively or additionally, be provided and/or stored on non-transitory tangible media, such as magnetic, optical, or electronic memory.

In some embodiments, console <NUM> further comprises a memory <NUM> and a display <NUM>, which is configured to display data, such as an image <NUM> of at least part of heart <NUM>. In some embodiments, image <NUM> may be acquired using any suitable anatomical imaging system.

Reference is now made to an inset <NUM>. A physician <NUM> inserts a shaft <NUM> through the vascular system of patient <NUM> lying on a table <NUM>. In some embodiments, catheter <NUM> comprises a balloon assembly <NUM> fitted at the distal end of shaft <NUM>. During the insertion of shaft <NUM>, balloon assembly <NUM> is maintained in a collapsed position by a sheath (not shown). By containing assembly <NUM> in the collapsed position, the sheath also serves to minimize vascular trauma along the way to a target location.

In some embodiments, physician <NUM> navigates balloon assembly <NUM> to the target location, such as a left atrium or another cavity of heart <NUM>, by manipulating shaft <NUM> using control handles <NUM> and <NUM> coupled to the proximal end of catheter <NUM>.

In some embodiments, physician applies handle <NUM> for controlling the navigation of shaft <NUM> and for manipulating the distal end of catheter <NUM>, e.g., so as to make contact between assembly <NUM> and tissue of heart <NUM>, as will be described in detail in <FIG> below. Once the distal end of shaft <NUM> has reached the target location, physician <NUM> extracts assembly <NUM> out of the sheath, referred to herein as an "unextended position," and allows a pump, such as an irrigation pump (not shown), to inflate balloon assembly <NUM> to an expanded position, as will also be described in detail in <FIG> below.

In some embodiments, the proximal end of catheter <NUM> is connected to interface circuitry in processor <NUM>, and is described in further detail in <FIG> below.

In some embodiments, the position of distal-end assembly <NUM> in the heart cavity is typically measured using position sensing techniques. This method of position sensing is implemented, for example, in the CARTO™ system, produced by Biosense Webster Inc. (Irvine, Calif. ) and is described in detail in <CIT>,<CIT>, <CIT>, <CIT>, <CIT> and <CIT>, in<CIT>, and in <CIT>, <CIT> and <CIT>.

In some embodiments, console <NUM> comprises a driver circuit <NUM>, which drives magnetic field generators <NUM> placed at known positions external to patient <NUM>, e.g., below the patient torso.

In some embodiments, when the distal end of catheter <NUM> is positioned in the target location (e.g., the cavity of heart <NUM>), physician <NUM> extracts balloon assembly <NUM> out of the sheath and applies handle <NUM> to manipulate assembly <NUM> such that an outer surface of assembly <NUM> makes a physical contact with tissue of the cavity.

In some embodiments, balloon assembly <NUM> comprises an inflatable balloon (not shown) made from polyethylene terephthalate (PET), polyurethane, polyamide, or any other suitable flexible material. The inflatable balloon is configured to receive inflation fluid into an internal volume of balloon assembly <NUM>.

In some embodiments, physician <NUM> may apply handle <NUM> to bring balloon assembly <NUM> to a non-extended position and allow it to fill with the inflation fluid, or by using any other suitable inflation technique. The level of inflation determines the shape of assembly <NUM> so that, in some embodiments, handle <NUM> is configured to control the level of inflation as will be described in detail in <FIG>, as well as in the method described in <FIG> below.

In some embodiments, handle <NUM> is further configured to control a deflection level of balloon assembly <NUM> relative to a longitudinal axis of catheter <NUM>. In case the contact between assembly <NUM> and the heart tissue is insufficiently firm, physician <NUM> may apply handle <NUM> to deflect assembly <NUM> so as to make improved contact between assembly <NUM> and the heart tissue.

In some embodiments, physician <NUM> may determine the levels of inflation and deflection of assembly <NUM> by setting one or more knobs (typically two knobs as shown in <FIG>) of handle <NUM> to a selected position.

In some embodiments, the operations of inflation and deflection may be carried out separately (e.g., an inflation operation followed by a deflection operation), in parallel (e.g., setting both the shape of the balloon and the deflection level simultaneously), alternately (e.g., by setting an initial shape followed by initial deflection, and subsequently inflating (or deflating) assembly <NUM> to a final shape and deflecting again so as to better reach the target tissue and achieve the intended level of physical contact between assembly <NUM> and the heart tissue. In other embodiments, any other suitable sequence of operations, or a different combination of the operations described above, may be used.

In some embodiments, assembly <NUM> further comprises one or more electrodes <NUM> (ten electrodes in the example of <FIG>), coupled to the outer surface of assembly <NUM> and configured to exchange electrical signals with the proximal end of catheter <NUM> and to conduct the electrical signals to or from the tissue of heart <NUM>. During a medical procedure, such as cardiac EP mapping or tissue ablation, electrodes <NUM> are brought into contact with the tissue of heart <NUM>, so as to sense electrical signals originated therefrom, or to apply ablation signals for ablating the tissue as described above.

In the context of the present disclosure, the term "electrodes" refers to sensing electrodes or to ablating electrodes configured to sense electrical signals from heart <NUM> or to ablate tissue of heart <NUM>, respectively.

The configuration of system <NUM> shown in <FIG> is an example configuration, which is chosen purely for the sake of conceptual clarity. In alternative embodiments, any other suitable configuration can also be used. For example, the size and shape of distal-end assembly <NUM>, and additional components, such as thermocouples and irrigation holes may be implemented in any suitable location in assembly <NUM>.

<FIG> is a schematic, pictorial illustration of handle <NUM> in a home position, in accordance with an embodiment of the present invention.

In some embodiments, handle <NUM> comprises a grip <NUM>, typically located at the proximal end of handle <NUM> and held by a hand of physician <NUM>. In the example of <FIG> physician <NUM> holds handle <NUM> in one hand, and uses the other hand located near the end of the sheath to further control the movement. We generally assume that the physician holds the catheter by his or her right hand, but a left-handed person may hold the handle by the left hand.

In some embodiments, handle <NUM> comprises a deflection knob <NUM>, which is configured to move along a longitudinal axis (shown in <FIG>) of catheter <NUM> so as to control the deflection of assembly <NUM> relative to the longitudinal axis of catheter <NUM>. In some embodiments, physician <NUM> may use the thumb (or one or more other fingers) of his or her right hand (i.e., the same hand holding the catheter handle) to advance knob <NUM>, so as to deflect assembly <NUM> relative to the longitudinal axis of catheter <NUM>.

In similar embodiments, physician <NUM> may use one or more fingers of his or her right hand to retract knob <NUM>, so as to align assembly <NUM> relative to the longitudinal axis of catheter <NUM>.

In some embodiments, handle <NUM> comprises a shape-control knob <NUM>, which is configured to control the shape of balloon assembly <NUM>. As described in <FIG> above, physician <NUM> may apply control knob <NUM> to control the shape of assembly <NUM> by elongating the balloon of assembly <NUM>, thus collapsing it and forcing out the inflation fluid through existing holes in the balloon.

In some embodiments, physician <NUM> may control the shape of assembly <NUM> by moving shape-control knob <NUM> using one or more fingers in a similar manner as described above for deflection knob <NUM>.

Note that both deflection knob <NUM> and shape-control knob <NUM> are located in close proximity to grip <NUM>, such that when physician holds grip <NUM>, for example, using his or her right hand, each of deflection knob <NUM> and control knob <NUM> is accessible by one or more fingers (e.g., the thumb) of the same hand that holds grip <NUM>.

In the example of <FIG>, deflection knob <NUM> and shape-control knob <NUM> are fully retracted so that assembly <NUM> is not inflated and is substantially aligned with the longitudinal axis of catheter <NUM>. This position is referred to herein as a "home position," which is the typical position of assembly <NUM> during introduction through the sheath.

<FIG> is a schematic, pictorial illustration of handle <NUM> in an extended position, in accordance with an embodiment of the present invention. In the context of the present disclosure and in the claims, the terms "expanded position", "extended position" and "inflated position" are used interchangeably and refer to a position in which balloon assembly <NUM> is fully (or partially) inflated with the inflation fluid.

In some embodiments, physician <NUM> may move deflection knob <NUM> over a deflection setting range <NUM> along axis <NUM> of handle <NUM>, in directions represented by a two-way arrow <NUM>, so as to set the degree of deflection of assembly <NUM> relative to axis <NUM>. For example, physician <NUM> may move deflection knob <NUM> to one end of deflection setting range <NUM> (e.g., the distal end), so as to obtain the maximal level of deflection of assembly <NUM>, and may similarly align assembly <NUM> with axis <NUM> by setting deflection knob <NUM> at the opposite (e.g., proximal) end of deflection setting range <NUM>. In some embodiments, the handle comprises mechanical stoppers at the ends of deflection setting range <NUM>.

In the example of <FIG>, deflection knob <NUM> is fully retracted to the proximal end of deflection setting range <NUM>, so that it makes contact with the mechanical stopper, such as the distal end of grip <NUM> that is configured to limit the motion of knob <NUM> within deflection setting range <NUM>.

In the example of <FIG>, knob <NUM> is fully advanced to the distal end of deflection setting range <NUM>, so that it makes contact with the mechanical stopper that prevents further deflection of assembly <NUM>.

In some embodiments, shape-control knob <NUM> is limited to move within a predefined range, referred to herein as a shape setting range <NUM> having, for example, a similar configuration and operational mode described above for the deflection setting range of deflection knob <NUM>.

In some embodiments, physician may advance shape-control knob <NUM> along shape setting range <NUM>, so as to extract the distal end of the balloon of assembly <NUM> to the unextended position, and to allow the irrigation pump to inflate the balloon with inflation fluid (not shown). In these embodiments, by sliding shape-control knob <NUM> forward to a certain position, physician <NUM> sets the shape of balloon assembly <NUM>.

In an embodiment, physician <NUM> may advance shape-control knob <NUM> along axis <NUM> in directions represented by a two-way arrow <NUM>, to the distal end of shape setting range <NUM> so as to set assembly <NUM> in an "inflated position.

Similarly, physician <NUM> may retract shape-control knob <NUM> to the proximal end of shape setting range <NUM>, referred to herein as "home position" of knob <NUM> as shown in <FIG>. In the home position of knob <NUM>, the balloon of assembly <NUM> is elongated so that the inflation fluid is forced out of the internal volume of assembly <NUM>, e.g., into the body of patient <NUM>, or into a reservoir (not shown) of system <NUM>.

Note that, when deflection knob <NUM> and shape-control knob <NUM> are, each, positioned at the distal end of respective ranges <NUM> and <NUM>, assembly <NUM> is fully deflected relative to axis <NUM> and is fully inflated. This extended position typically assists physician <NUM> in manipulating assembly <NUM> to make the intended contact of the balloon catheter with the target tissue of heart <NUM>.

In some embodiments, deflection knob <NUM> can be positioned at any point along deflection setting range <NUM>. In alternative embodiments, deflection knob <NUM> can be set only at one or more predefined positions along the range.

In some embodiments, deflection knob <NUM> and shape-control knob <NUM> may be fitted on the distal end of grip <NUM> as shown in <FIG>, or may be coupled to handle <NUM> using any other suitable configuration and coupling technique. For example, deflection knob <NUM> and shape-control knob <NUM> may be fitted on handle <NUM> side-by-side instead of after one another along axis <NUM>.

In some embodiments, shape-control at least one of knobs <NUM> and <NUM> may have one or more numbers marked on the surface, as shown in <FIG>. In an embodiment, each number indicates a position of a respective electrode <NUM> on the outer surface of assembly <NUM>, so as to assist physician <NUM> in knowing the orientation of balloon assembly <NUM> in heart <NUM>, without relying on a mapping system or X-ray visualization. In other embodiments, the numbers, or any other suitable marker, may be used to indicate the position of any device, such as one or more electrodes and/or sensors coupled to the outer surface of assembly <NUM>.

In the example of <FIG>, deflection knob <NUM> and shape-control knob <NUM> are movable along respective linear ranges (e.g., deflection setting range <NUM> and shape setting range <NUM>) along axis <NUM>. In alternative embodiments, at least one of these ranges may have a nonlinear shape, such as a curved shape or any other suitable shape. For example, deflection knob <NUM> may control the deflection of assembly <NUM> by rotating, rather than by moving in a linear range.

<FIG> is a flow chart that schematically illustrates a method for conducting a medical procedure using balloon catheter <NUM>, in accordance with an embodiment of the present invention. The method begins at a catheter insertion step <NUM>, with physician <NUM> inserting catheter <NUM> into the body of patient <NUM> and navigating assembly <NUM> to the cavity of heart <NUM>. At a balloon inflation step <NUM>, physician <NUM> advances shape-control knob <NUM> towards the distal end of shape setting range <NUM>, unextending balloon and then inflates assembly <NUM> with the inflation fluid using the irrigation pump.

At a balloon deflection step <NUM>, physician <NUM> advances deflection knob <NUM> towards the distal end of deflection setting range <NUM>, so as to deflect assembly <NUM> relative to axis <NUM>. In some embodiments, physician <NUM> may check, after concluding each of steps <NUM> and <NUM>, whether assembly <NUM> makes the intended contact with the tissue of heart <NUM>. In case the intended contact is not obtained, physician <NUM> may repeat step <NUM> and/or step <NUM> until the intended contact between assembly <NUM> and the tissue is obtained.

After bringing assembly <NUM> into the intended contact with the tissue, physician <NUM> may carry out the medical procedure, such as ablating the tissue of heart <NUM>, at a treatment step <NUM>. In some embodiments, the medical procedure may involve diagnostics, such as sensing of EP signals from the tissue of heart <NUM>.

After concluding the medical procedure, physician <NUM> may align assembly <NUM> with axis <NUM> by retracting deflection knob <NUM> to the proximal end of deflection setting range <NUM>, at a distal end alignment step <NUM>.

At a deflating step <NUM>, physician retracts shape-control knob <NUM> to the proximal end of shape setting range <NUM>, so as to force the fluid out of the internal volume of assembly <NUM>, thereby to set assembly <NUM> in the unextended position. After concluding step <NUM>, handle <NUM> is set at home position as shown in <FIG> above.

In some embodiments, physician <NUM> may change the order between steps <NUM> and <NUM>, or may apply any suitable sequence as described in <FIG> above, so as to obtain, before applying the medical procedure at step <NUM>, the intended contact between assembly <NUM> and the tissue of heart <NUM>.

In some embodiments, after concluding the medical procedure at step <NUM>, physician <NUM> may change the order between steps <NUM> and <NUM>, or may apply any other suitable sequence, so as to set handle <NUM> at home position.

In some embodiments, after inflating balloon assembly <NUM> at step <NUM> physician <NUM> may extract balloon assembly <NUM> out of the sheath, as described in <FIG> above. In some embodiments, after concluding step <NUM>, assembly <NUM> is in the unextended position and aligned with axis <NUM>. At this stage, physician <NUM> may insert assembly <NUM> into the sheath, thereby setting assembly <NUM> at a collapsed position.

At a retraction step <NUM>, physician retracts catheter <NUM> so as to extract assembly <NUM> out of the body of patient <NUM>. Step <NUM> concludes the method of <FIG>.

Although the embodiments described herein mainly address cardiac arrhythmia, the methods and systems described herein can also be used in other applications, such as in electrophysiology, ablation of tissue, sinuplasty, surgery, endoscopy, angioplasty, otolaryngology and neurology.

Claim 1:
A medical instrument, comprising:
a first knob (<NUM>), which is fitted on a handle (<NUM>) of the medical instrument, and which is movable along a longitudinal axis (<NUM>) of the medical instrument to control a deflection of a medical device coupled to a distal end of the medical instrument relative to the longitudinal axis, wherein the medical device comprises at least one of electrodes (<NUM>) and sensors coupled to the medical device at predefined positions; and
a second knob (<NUM>), which is fitted on the handle of the medical instrument, and which is movable along the longitudinal axis to control a shape of the medical device, wherein at least one of the first and second knobs comprises one or more markers indicative of the respective positions of the at least one of electrodes and sensors.