Patent Description:
Balloon sinuplasty is a procedure that ear, nose and throat surgeons may use for the treatment of blocked sinuses. The procedure involves inserting a balloon over a wire guidewire to a sinus passageway. After insertion, the balloon is inflated with the goal of widening the walls of the sinus passageway.

Documents incorporated by reference in the present patent application are to be considered an integral part of the application except that, to the extent that any terms are defined in these incorporated documents in a manner that conflicts with definitions made explicitly or implicitly in the present specification, only the definitions in the present specification should be considered.

<CIT> describes a guidewire movement mechanism configured to translate to thereby cause translation of the guidewire relative to a handle. The guidewire movement mechanism includes a rotation mechanism configured to impart rotation upon the guidewire.

An embodiment of the present invention provides a manipulator, including:.

Typically, the first wheel includes a first wheel axle, the adjuster further including retaining slots configured to accept the axle, so that on rotation of the first wheel about the first wheel axle the first wheel slides in the retaining slots to engage the guidewire.

In a disclosed embodiment the second wheel rotates about a second wheel axis, the adjuster further including a plurality of cylinders enclosed by the second wheel and having respective axes parallel to the second wheel axis, so that on rotation of the second wheel about the second wheel axis, the cylinders move orthogonally to their axes to engage the guidewire. The second wheel may contain an open triangular portion, and the plurality of cylinders consists of three cylinders located at respective apices of the triangular portion. Typically, on rotation of the second wheel about the second wheel axis, the cylinders are pushed inwards by sides of the triangular portion so as to engage the guidewire.

In a further disclosed embodiment the balloon is attached in a fluid-tight manner to the port at a proximal end of the balloon.

In a yet further disclosed embodiment the manipulator includes a balloon retaining tube, traversing the port, attached to a distal end of the balloon.

In an alternative embodiment the U-shaped channel contains a passage configured to restrain the balloon and the guidewire from deviating out of the passage. Typically, the balloon translates along the passage when the adjuster slides in the U-shaped channel.

In a further alternative embodiment the manipulator includes a rigid tube, removably attached to the elongated chassis, configured to accept the tubular balloon and the guidewire. Typically, the rigid tube is attached in a position not in line with the elongated chassis.

There is further provided, according to an embodiment of the present invention, a guidewire, including:.

In a disclosed embodiment the plastic tube includes a first plastic tube cemented to a second plastic tube, and the lumen is common to the first and second tubes. The first and the second plastic tubes may have differing flexibilities. The first and the second plastic tubes may have differing thicknesses.

The present disclosure will be more fully understood from the following detailed description of the embodiments thereof, taken together with the drawings, in which:.

<FIG> is a schematic perspective view of a sinuplasty guidewire and balloon manipulator <NUM>, <FIG> is a partly exploded view of the manipulator, <FIG> is an enlarged section of the exploded view as seen from above, and <FIG> is an enlarged section of the exploded view as seen from below, according to an embodiment of the present invention. As is described in more detail below, manipulator <NUM> is configured to enable a physician performing a sinuplasty procedure to single-handedly manipulate a guidewire used for the procedure, as well as to advance and retract a balloon used in the procedure. A distal section <NUM> of the manipulator is also described below.

Manipulator <NUM> comprises an elongated generally U-shaped chassis <NUM> to which is movably attached a chassis holder <NUM>. In one embodiment chassis <NUM> is formed as two mirror image sections 24A, 24B which are cemented together. Holder <NUM> is designed to be held by and conform to the fingers of the physician, and the holder may be positioned and fixed distally/proximally with respect to the chassis by sliding the holder along a ridge <NUM> formed in the external base of chassis <NUM>.

Retained within a U-shaped channel <NUM> of the chassis is a guidewire position adjuster <NUM>. The channel defines distal and proximal directions for the chassis. As explained in more detail below, adjuster <NUM> enables the physician holding the manipulator to translate and rotate a guidewire <NUM> passing through the adjuster. The translation, which may be in a distal direction or a proximal direction, is along an axis of the guidewire, as illustrated by a double-headed arrow <NUM>, and the rotation is around an axis of the guidewire, as illustrated by a double-headed arrow <NUM>. The translation and rotation may be performed by a single finger, or the thumb, of the physician's hand holding the manipulator. (As is also described below, adjuster <NUM> enables the physician to translate and inflate a sinuplasty balloon attached to the adjuster. The adjuster typically comprises channels for the inflation, which may be performed by a device such as a pump connected to the adjuster.

Adjuster <NUM> comprises three wheels, a first wheel <NUM> which is rotatable about an axis orthogonal to the axis of guidewire <NUM>, a second wheel <NUM> which is rotatable about an axis parallel to the axis of the guidewire, and a third wheel <NUM> which has a rotation axis parallel to the axis of wheel <NUM>. Wheel <NUM> is internal to adjuster <NUM>, and so is not visible in <FIG>, but is illustrated in <FIG> below.

<FIG> and <FIG> illustrate adjuster <NUM>, according to an embodiment of the present invention. In <FIG> second wheel <NUM> is not shown, so as to illustrate internal structure within the second wheel. <FIG> is a sectional illustration of adjuster <NUM> and a portion of manipulator <NUM>, so as to illustrate internal structure related to first wheel <NUM>.

As shown in <FIG>, adjuster <NUM> comprises a slot <NUM> which retains an axle <NUM> (<FIG>) of wheel <NUM>. Slot <NUM> allows the axle, and its wheel, to move orthogonally with respect to the guidewire. In the absence of pressure from a finger of the physician, axle <NUM> is situated in the upper part of the slot and wheel <NUM>, while contacting the guidewire, does not engage it. In this situation, the guidewire is free to move with respect to wheel <NUM>.

When the physician applies pressure to wheel <NUM>, for example by rotating the wheel with a finger or thumb, the axle <NUM> moves down in slot <NUM>, so that wheel <NUM> engages guidewire <NUM> and presses the guidewire against a freely rotating wheel <NUM>. Thus, while the physician applies pressure so as to rotate wheel <NUM>, the guidewire translates along its axis, in the direction of arrow <NUM> (<FIG>). Conversely, if the physician does not apply pressure to rotate wheel <NUM>, the guidewire is not engaged by the wheel so is not constrained in a guidewire axial direction by the wheel.

Wheel <NUM> (<FIG>) performs a generally similar function to wheel <NUM>, so that in the case of the physician applying pressure on wheel <NUM> so as to rotate the wheel, the guidewire rotates about its axis, in the direction of arrow <NUM> (<FIG>). On the other hand, if no pressure is applied, there is no engagement of the wheel with the guidewire, as explained below.

Within wheel <NUM>, and enclosed by the wheel, are three generally similar cylinders <NUM>, which have axes parallel to the axis of wheel <NUM>. Cylinders <NUM> are arranged at the apices of an equilateral triangle, and the cylinders are retained in place by end portions <NUM> and <NUM> which also hold wheel <NUM>.

<FIG> shows schematic cross-sections of wheel <NUM> in two states, according to an embodiment of the present invention. As shown in both diagrams <NUM> and <NUM>, an internal portion <NUM> of wheel <NUM> has a generally triangular open cross-section. In a first "relaxed" state of wheel <NUM>, schematically illustrated in diagram <NUM>, wheel <NUM> is not rotated, and while cylinders <NUM> may contact guidewire <NUM> because of the force of gravity, there is substantially no frictional force preventing guidewire movement along its axis. In a second rotating state of the wheel, illustrated in diagram <NUM>, cylinders <NUM> are pushed inwards by the sides of triangular portion <NUM>, moving orthogonally to their axes, and so engage guidewire <NUM>. The engagement causes the guidewire to rotate.

As is shown in <FIG>, adjuster <NUM> is also attached in a watertight manner to a sinuplasty tubular balloon <NUM>. As is described below, application of a fluid to the balloon causes the balloon to expand at its distal end.

<FIG> shows schematic cross-sections of balloon <NUM> as it is attached to a port <NUM> in adjuster <NUM>, according to an embodiment of the present invention. Port <NUM> is at a distal end of adjuster <NUM>, and thus is distal to wheels <NUM> and <NUM>. Guidewire <NUM> exits from the adjuster, and passes through a central lumen <NUM> of tubular balloon <NUM>. Balloon <NUM> is attached in an air/watertight, i.e., a fluid-tight, manner to port <NUM> at the balloon's proximal end. The balloon is also attached at its distal end to a balloon retaining tube <NUM>, and the retaining tube traverses port <NUM> and is attached at its proximal end to adjuster <NUM>. The balloon may be filled with a fluid, such as pressurized air or a saline solution, via a channel <NUM> (port <NUM>, tube <NUM>, and channel <NUM> are also shown in <FIG>) incorporated in adjuster <NUM>. A diagram <NUM> illustrates the balloon and the guidewire in the balloon's unexpanded state; a diagram <NUM> illustrates the balloon and the guidewire when the balloon has been expanded by injection of fluid (liquid or air) into the balloon via channel <NUM>. For simplicity, other elements of manipulator <NUM>, described below, are not shown in <FIG>.

<FIG> illustrates a straight passage <NUM> within U-shaped channel <NUM>, according to an embodiment of the present invention. (Passage <NUM> is also shown in <FIG>. ) Balloon <NUM> fits into passage <NUM>, and the passage is configured to restrain the balloon, and also guidewire <NUM>, from deviating out of the passage. Adjuster <NUM> is configured to be translatable in a distal direction or a proximal direction along U-shaped channel <NUM>, and it will be understood that when it is translated, balloon <NUM> also translates in passage <NUM>.

<FIG> illustrates distal section <NUM> of manipulator <NUM>, and <FIG> illustrates the distal section in a partially exploded form, according to an embodiment of the present invention. Section <NUM> comprises a rigid tube <NUM>, which is coupled, as described below, to chassis <NUM> so that a proximal end of the tube aligns with a distal end of passage <NUM>. A distal end <NUM> of tube <NUM> is formed of interlocking articulated sections <NUM>, and the sections can be deflected or undeflected by turning of a knurled knob <NUM> in a clockwise or a counterclockwise direction. Sections <NUM> may be coupled to knob <NUM> by any convenient method known in the art. A method for coupling sections <NUM> to knob <NUM> so as to achieve the deflection and undeflection referred to herein is described in <CIT>. The method uses a metal ribbon, having a curved cross-section, that connects sections <NUM> to knob <NUM>, so that rotation of the knob translates the ribbon distally or proximally along tube <NUM>. Optionally, tube <NUM> comprises orifices <NUM> via which irrigation fluid may be ejected from the tube.

Tube <NUM> fits fixedly into a tube housing <NUM>, but the tube may be removed from the housing, exposing a cylindrical element <NUM>, as is shown in <FIG>. The tube may then be rotated, and the element <NUM> may then be reinserted into the housing, and once in the housing the tube and element <NUM> may be locked in place with a lock <NUM>. Such removal and reinsertion enables the deflection of sections <NUM> of distal end <NUM> to be in any selected direction with respect to the axis of tube <NUM>.

<FIG> and <FIG> show tube <NUM> in line with chassis <NUM>. However, the tube may be rotated into one or more fixed positions so that while it is not in line with the chassis a proximal end of the tube still aligns with a distal end of passage <NUM>. To accomplish this rotation, a distal portion <NUM> of chassis <NUM> is configured with a protruding axis <NUM> which is orthogonal to the axis of tube <NUM>. In addition, axis <NUM> is configured to rotatingly mate with a circular hole <NUM> in a distal portion <NUM> of chassis <NUM>, and a tooth <NUM> in housing <NUM> can fit into one of a number of receiving indentations <NUM> in distal portion <NUM>. Once tooth <NUM> is fit into one of indentations <NUM>, tube <NUM> may be locked with respect to rotation about axis <NUM> with a lock <NUM>.

The ability of tube <NUM> to be rotated with respect to chassis <NUM> facilitates use of manipulator <NUM> during a sinuplasty procedure, since, as is known, such procedures typically require the use of other tools, such as an endoscope, in confined areas of operation such as the nostrils of a patient.

<FIG>, <FIG>, and <FIG> schematically illustrate guidewire <NUM>, according to an embodiment of the present invention. <FIG> illustrates a distal portion <NUM> of the guidewire in a cutaway form, and part of a proximal portion <NUM> of the guidewire. In one embodiment the overall length of guidewire <NUM> is approximately <NUM>, and distal portion <NUM> is approximately <NUM>, but other embodiments may have different values for the overall length and for the length of the distal portion.

Proximal portion <NUM> and distal portion <NUM> respectively comprise cylindrical plastic tubes <NUM> and <NUM>. The tubes are cemented together, and form a common lumen <NUM> within the tubes. A nitinol wire <NUM> is located in lumen <NUM> and typically traverses the full length of the guidewire, although in some embodiments it may be shorter.

Tubes <NUM> and <NUM> are typically formed from a plastic such as polyimide or polyamide, and each tube is reinforced for example by a braid incorporated into the tube. The braid is typically braided stainless steel. Alternatively, the braid may comprise a braided polymer where the polymer may also be formed from polyimide.

Distal portion <NUM> is typically configured to be slightly more flexible than proximal portion <NUM>. The difference in flexibility may be achieved by forming the two sections from plastics having different appropriate properties. Alternatively or additionally, tube <NUM> may be configured to be thicker than tube <NUM>.

<FIG> schematically shows cross-sections of tubes <NUM> and <NUM>, taken orthogonal to an axis <NUM> of the guidewire. Tube <NUM> has a braid <NUM> incorporated into the tube. Tube <NUM> has a braid <NUM> incorporated into the tube. Wires <NUM>, in lumen <NUM>, traverse the full length of the guidewire, and the function of the wires is described below.

<FIG> schematically shows a distal end <NUM> of distal portion <NUM>. End <NUM> comprises a single axis coil <NUM> which acts as a position sensor. Coil <NUM> is wound on a polyimide tube <NUM>, the tube being penetrated by nitinol wire <NUM>. Wires <NUM> (shown in <FIG> as a cylinder) connect to the single axis coil, and convey signals generated in the coil back to manipulator <NUM>, and from there to a processor (not shown in the figures). Signals generated by the coil, due to alternating magnetic fields traversing the coil, enable the processor to determine the location and orientation of the coil. Such a system is well known in the art, and is used, for example, in the Carto system produced by Biosense Webster of Technology Drive, Irvine, CA <NUM> USA.

Distal end <NUM> is sealed at its tip by a biocompatible cement plug <NUM> so that lumen <NUM> is water and air-tight.

In one embodiment, nitinol wire <NUM> is slightly bent, typically by approximately <NUM>°, so that distal end <NUM> is also bent with respect to the remaining part of the guidewire.

Claim 1:
A manipulator (<NUM>), comprising:
an elongated chassis (<NUM>) containing a U-shaped channel (<NUM>) defining a distal direction and a proximal direction; and
an adjuster (<NUM>) configured to slide in the U-shaped channel, the adjuster comprising:
a first wheel (<NUM>) which, on rotation, is configured to translate a guidewire (<NUM>) positioned in the adjuster along an axis of the guidewire, wherein the first wheel comprises a first wheel axle (<NUM>);
retaining slots (<NUM>) configured to accept the axle, so that on rotation of the first wheel about the first wheel axle the first wheel slides in the retaining slots to engage the guidewire;
a second wheel (<NUM>) which, on rotation, is configured to rotate the guidewire positioned in the adjuster about the axis of the guidewire; and
a port (<NUM>), distal to the first and the second wheel, configured to accept a tubular balloon (<NUM>) and the guidewire,
wherein the first wheel is configured to engage the guidewire on application of pressure to rotate the first wheel and to disengage the guidewire when no pressure is applied to rotate the first wheel.