Patent Description:
A wide range of medical procedures involve placing probes, such as catheters, within a patient's body. Location sensing systems have been developed for tracking such probes. Magnetic location sensing is one of the methods known in the art. In magnetic location sensing, magnetic field generators are typically placed at known locations external to the patient. A magnetic field sensor within the distal end of the probe generates electrical signals in response to these magnetic fields, which are processed to determine the coordinate locations of the distal end of the probe. These methods and systems are described in <CIT>, <CIT>, <CIT>, <CIT>,<CIT> and <CIT>, in <CIT>, and in <CIT> and <CIT> and <CIT>. Locations may also be tracked using impedance or current based systems.

One medical procedure in which these types of probes or catheters have proved extremely useful is in the treatment of cardiac arrhythmias. Cardiac arrhythmias and atrial fibrillation in particular, persist as common and dangerous medical ailments, especially in the aging population.

Diagnosis and treatment of cardiac arrhythmias include mapping the electrical properties of heart tissue, especially the endocardium, and selectively ablating cardiac tissue by application of energy. Such ablation can cease or modify the propagation of unwanted electrical signals from one portion of the heart to another. The ablation process destroys the unwanted electrical pathways by formation of non-conducting lesions. Various energy delivery modalities have been disclosed for forming lesions, and include use of microwave, laser and more commonly, radiofrequency energies to create conduction blocks along the cardiac tissue wall. In a two-step procedure, mapping followed by ablation, electrical activity at points within the heart is typically sensed and measured by advancing a catheter containing one or more electrical sensors into the heart, and acquiring data at a multiplicity of points. These data are then utilized to select the endocardial target areas at which the ablation is to be performed.

Electrode catheters have been in common use in medical practice for many years. They are used to stimulate and map electrical activity in the heart and to ablate sites of aberrant electrical activity. In use, the electrode catheter is inserted into a major vein or artery, e.g., femoral vein, and then guided into the chamber of the heart of concern. A typical ablation procedure involves the insertion of a catheter having a one or more electrodes at its distal end into a heart chamber. A reference electrode may be provided, generally taped to the skin of the patient or by means of a second catheter that is positioned in or near the heart. RF (radio frequency) current is applied through the tip electrode(s) of the ablating catheter, and current flows through the media that surrounds it, i.e., blood and tissue, between the tip electrode(s) and an indifferent electrode. The distribution of current depends on the amount of electrode surface in contact with the tissue as compared to blood, which has a higher conductivity than the tissue. Heating of the tissue occurs due to its electrical resistance. The tissue is heated sufficiently to cause cellular destruction in the cardiac tissue resulting in formation of a lesion within the cardiac tissue which is electrically non-conductive.

<CIT>, describes an apparatus and method for performing a verification buy-off operation during an assembly manufacturing process, such as during printed circuit board (PCB) manufacturing. A processing device is configured to establish contact between a probe assembly and a first component of an assembly having a plurality of components loaded in predetermined positions but not yet electrically intercoupled, and to receive from the probe assembly a component value associated with the first component. Preferably, the processing device further determines whether the received component value is within a predetermined specification. The processing device preferably directs a user via a graphical user interface (GUI) to manipulate the probe assembly to a position proximate the first component. The GUI preferably provides a graphical representation of the assembly and a marker that identifies the location of the first component thereon. All of the components of the assembly are preferably verified individually prior to a full production run.

<CIT>, describes an interconnectable circuit board which includes one or more of the following features: (a) a first electrically conductive pad located on a top of the circuit board, (b) a plated through hole on the conductive pad which passes through the circuit board, (c) a second electrically conductive pad coupled to the plated through hole; the second conductive pad capable of being electrically connected to a third electrically conductive pad attached to a top of a second interconnectable circuit board, (d) cut marks indicating safe locations for separating the circuit board, and (e) a second cut mark adjacent to the first cut mark where the area between the first and second cut mark can be utilized to make a safe cut through the circuit board.

For further background, <CIT> describes a system for sensing multiple local electric voltages from endocardial surface of a heart, including: a first elongate tubular member having a lumen, a proximal end and a distal end; a basket assembly including: a plurality of flexible splines for guiding a plurality of exposed electrodes, the splines having proximal portions and distal portions; an anchor for securably affixing the proximal portions of the splines; the anchor being secured at the distal end of the first elongate tubular member; an encapsulated and filament-wrapped distal tip including an encapsulant and a filament for securably affixing the distal portions of the splines in a predetermined angular relationship at the distal tip; wherein the splines comprise a superelastic material; wherein the basket assembly has a radially expanded non-cylindrical shape.

<CIT> describes a thermal neuromodulation apparatus, system, and methods for the ablative and non-ablative application of thermal energy to the renal nerves of a patient. The thermal neuromodulation apparatus includes an elongated, hollow body configured to traverse the tortuous intravascular pathways of the renal vasculature and includes an expandable structure bearing electrodes and configured to selectively apply thermal energy via electric fields to the renal nerves through a vessel wall. <CIT> refers to a further prior art document relevant for the present invention.

There is provided in accordance with an embodiment of the present disclosure, a catheter manufacturing method, including forming flexible circuit strips with respective different symbols marked thereon, each strip including at least one respective electrode, attaching one end of each of the flexible circuit strips to a catheter coupler with the flexible circuit strips being ordered around a circumference of the catheter coupler responsively to the respective symbols of respective ones of the flexible circuit strips, and forming a distal end assembly of a catheter, the distal end assembly including the flexible circuit strips attached to the catheter coupler.

Further in accordance with an embodiment of the present disclosure, the method includes connecting the catheter coupler to an elongated deflectable element.

Still further in accordance with an embodiment of the present disclosure the forming the flexible strips includes forming the flexible circuit strips with respective alignment markings, and the attaching includes aligning the end of each of the flexible circuit strips to the catheter coupler responsively to the respective alignment markings of respective ones of the flexible circuit strips.

Additionally, in accordance with an embodiment of the present disclosure, the method includes forming a flexible circuit panel including the flexible circuit strips in uncut form, and cutting the flexible circuit panel to form the flexible circuit strips as separated strips.

Moreover, in accordance with an embodiment of the present disclosure forming the flexible circuit panel includes forming the flexible circuit panel with multiple copies of each of the symbols.

Further in accordance with an embodiment of the present disclosure, the method includes aligning the distal end assembly with a position tracking system responsively to one of the symbols of a respective one of the flexible circuit strips, and performing a calibration of the catheter with the position tracking system responsively to the aligning.

Still further in accordance with an embodiment of the present disclosure, the method includes aligning a plane of deflection of the distal end assembly with a deflection measurement element responsively to one of the symbols of a respective one of the flexible circuit strips, deflecting the catheter, and checking a deflection of the catheter with the deflection measurement element.

Additionally, in accordance with an embodiment of the present disclosure, the method includes checking a continuity of electrodes of the catheter responsively to respective ones of the symbols of respective ones of the flexible circuit strips.

There is also provided in accordance with another embodiment of the present disclosure, a catheter calibration method, including connecting a catheter with a position tracking system, the catheter including a distal end assembly including flexible circuit strips with respective different symbols marked thereon, each strip including at least one respective electrode, one end of each of the flexible circuit strips being connected to a catheter coupler with the flexible circuit strips being ordered around a circumference of the catheter coupler responsively to the respective symbols of respective ones of the flexible circuit strips, aligning the distal end assembly with the position tracking system responsively to one of the symbols of a respective one of the flexible circuit strips, and performing a calibration of the catheter with the position tracking system responsively to the aligning.

There is also provided in accordance with still another embodiment of the present disclosure, a catheter device, including a distal end assembly including flexible circuit strips with respective different symbols marked thereon, each strip including at least one respective electrode, and a catheter coupler, one end of each of the flexible circuit strips being connected to the catheter coupler with the flexible circuit strips being ordered around a circumference of the catheter coupler responsively to the respective symbols of respective ones of the flexible circuit strips.

Moreover, in accordance with an embodiment of the present disclosure, the device includes an elongated deflectable element connected to the catheter coupler.

When testing catheters such as a basket catheter it is often easy to confuse one spline of the basket with another, especially if the catheter is bidirectional as there is no easy curve indicator to align to. For example, if the catheter has ten or more splines it is often hard to choose which of the two splines is most in plane with the deflection curve in order to test the deflection of the catheter.

During assembly, the electrodes on the splines are checked for continuity and if the testing operator confuses one spline with another, it can create erroneous readings or delays in testing.

One solution to the above problems is to provide additional electrode rings on one or more of the splines to help distinguish one spline from the other. While an additional electrode may be a useful indicator, it only identifies one or two of the splines and requires some interpretation.

The present invention solves the above problems by directly labelling the flexible circuit strips of catheter splines with letters (e.g., A, B, C etc.) or other symbols (e.g., numerals). Any character or shape that is legible can be applied to the circuit. The letters or other symbols may then be used in catheter manufacture to easily determine how the splines should be connected to the rest of the catheter. The letters or other symbols may also be useful during testing and configuration by easily allowing an operator to align the catheter according to the letters or symbols shown on the splines. For example, during configuration, the catheter may be easily aligned to a position tracking system using the letters or other symbols. The letters or symbols may also be useful to identify problems with the catheter or its configuration. The letters or symbols may be easily added to the flexible circuit design along with the functional component of the flexible circuit strips.

Alignment marks (e.g., lines) may also be added to flexible circuit strips to help align parts during manufacture rather than relying upon additional measurements. These alignment marks may also serve as additional post-assembly checks to verify that the device was assembled properly.

It should be noted that the differently labeled strips may also comprise different electrical functionality and/or a different number and/or a different spacing of electrodes. In other embodiments, two or more of the differently labeled strips may be identical apart from the different labeling.

A problem may occur when assembling basket catheters from splines formed from a panel of flexible circuits which includes individual strips. If one of the strips is faulty, the whole set may need to be discarded. Embodiments of the present invention provide a more cost-effective manufacturing process by labelling the flexible circuit strips with letters or symbols and providing duplicate flexible circuit strips on a single panel so that if one strip is faulty, another one with the same letter of symbol may be used instead. For example, <NUM> circuit strips may be formed on a single flexible circuit panel with the strips being labeled A through J (for example) again and again. The flexible circuit panel is then cut up. If one of the strips (or splines) marked "A" (for example) proves to be faulty, another "A" strip (or spline) may be used instead, and so on.

The present invention includes a catheter device including a distal end assembly comprising flexible circuit strips with respective different symbols marked thereon, each strip including at least one respective electrode. The catheter device also includes a catheter coupler. One end of each flexible circuit strip is connected to the catheter coupler with the flexible circuit strips being ordered around a circumference of the catheter coupler responsively to the respective symbols (e.g., in the order A, B, C and so on from some marker) of the flexible circuit strips. In some embodiments an elongated deflectable element is connected proximally to the catheter coupler. In other embodiments the catheter coupler is formed integrally with the elongated deflectable element.

The present invention includes a catheter manufacturing method which includes forming a distal end assembly of a catheter from flexible circuit strips attached to a catheter coupler which may be connected proximally to an elongated deflectable element. The method also includes forming the flexible circuit strips with respective different symbols marked thereon and optionally with respective alignment markings. Each strip generally includes one or more electrodes.

In some embodiments, the method includes forming a flexible circuit panel which comprises the flexible circuit strips in uncut form, and cutting the flexible circuit panel to form the flexible circuit strips as separated strips. In some embodiments, forming the flexible circuit panel includes forming the flexible circuit panel with multiple copies of each of the symbols, for example, multiple strips with letter A thereon, and multiple strips with letter B thereon, and so on.

The method of the invention includes attaching one end of each flexible circuit strip to the catheter coupler with the flexible circuit strips being ordered around a circumference of the catheter coupler responsively to the respective symbols of the flexible circuit strips. The flexible circuit strips may be ordered around the catheter coupler according to the letters marked on the strips starting at letter A, followed by letter B, and so on. In some embodiments, the attaching includes aligning the end of each flexible circuit strip to the catheter coupler responsively to the respective alignment markings of the flexible circuit strips.

During testing of the catheter, the method may include aligning a plane of deflection of the distal end assembly with a deflection measurement element responsively to one or more of the symbols of one or more of the flexible circuit strips (e.g., aligning the strips marked A and F with a plane of the deflection measurement element, deflecting the catheter (e.g., to a maximum deflection), and checking a deflection of the catheter with the deflection measurement element. In some embodiments, deflection measurement element may include a laminated paper drawing may be used which shows a nominal curve and an acceptable zone in which the deflectable area may fall.

During other testing of the catheter, the method may include checking a continuity of electrodes of the catheter responsively to the symbols of the flexible circuit strips. For example, the electrodes may be tested for the strip marked with letter A, followed by the strip marked with letter B, and so on.

During a calibration procedure, the method may include aligning the distal end assembly with a position tracking system (e.g., a magnetic position tracking system) responsively to one or more of the symbols of one or more of the flexible circuit strips (e.g., aligning the strip marked A with an axis of a magnetic radiator), and performing a calibration of the catheter with the position tracking system responsively to the aligning.

Reference is now made to <FIG>, which is a schematic view of a catheter <NUM> constructed and operative in accordance with an embodiment of the present invention. The catheter <NUM> described with reference to <FIG> is a basket catheter by way of example. The catheter <NUM> may be implemented as any suitable spline-based catheter, for example, the PENTARAY® of Biosense Webster of Irvine, California. The catheter <NUM> described with reference to <FIG> includes ten splines. The catheter <NUM> may be implemented with any suitable number of splines.

The catheter <NUM> includes an elongated deflectable element <NUM> having a distal end <NUM>, a coupler <NUM> connected to the distal end <NUM>, and a pusher <NUM> including a distal portion <NUM>. The pusher <NUM> is configured to be advanced and retracted through the deflectable element <NUM>, for example, using a manipulator or handle (not shown). The catheter <NUM> also includes a distal end assembly <NUM> comprising a plurality of flexible circuit strips <NUM> (only some labeled for the sake of simplicity). Each flexible circuit strip <NUM> includes multiple electrodes <NUM> disposed thereon (only some labeled for the sake of simplicity). In some embodiments, a strip <NUM> may include one electrode <NUM>. The coupler <NUM> is connected to the elongated deflectable element <NUM>. The proximal end of the coupler <NUM> may be connected to the elongated deflectable element <NUM> using any suitable connection method, such as using adhesive, for example, epoxy. In some embodiments, the coupler <NUM> and the elongated deflectable element <NUM> are formed as an integral element. The catheter <NUM> also includes a nose connector <NUM> connected distally to the pusher <NUM>. One end of each flexible circuit strip <NUM> is connected to the inner surface of the coupler <NUM> and another end of each flexible circuit strip <NUM> is connected to the inner surface of the nose connector <NUM> as described in more detail with reference to <FIG>. The catheter <NUM> also includes a nose cap <NUM> covering the distal end of the nose connector <NUM>. The ends of the flexible circuit strips <NUM> are folded over into the nose connector <NUM>. In some embodiments, the ends of the flexible circuit strips <NUM> may not be folded over.

Each flexible circuit strip <NUM> is backed with an elongated resilient support element <NUM> (only one labeled for the sake of simplicity) providing a shape of the distal end assembly <NUM> in the expanded form of the distal end assembly <NUM>. The elongated resilient support elements <NUM> may include any suitable material, for example, but not limited to, Nitinol and/or Polyetherimide (PEI). The elongated resilient support elements <NUM> may run from the proximal end of the flexible circuit strips <NUM> until hinges <NUM> (only one labeled for the sake of simplicity) described in more detail with reference to <FIG>. In some embodiments, the elongated resilient support elements <NUM> are optional.

Reference is now made to <FIG>, which is a schematic view of a flexible circuit panel <NUM> constructed and operative in accordance with an embodiment of the present invention. The flexible circuit strips <NUM> may be formed from a single piece of polymer, such as polyimide. Circuit strips <NUM> may be connected to each other by polyimide, or assembled as individual pieces that are held in proper alignment and secured to coupler <NUM>. Respective first ends <NUM> of the respective flexible circuit strips <NUM> include an electrical connection array <NUM>. An inset <NUM> shows that the electrical connection array <NUM> includes electrical contacts <NUM> thereon (only some labeled for the sake of simplicity). The electrical contacts <NUM> are connected via traces (not shown) on the back of the flexible circuit strips <NUM> to respective ones of the electrodes <NUM> disposed on the front of the flexible circuit strips <NUM>. Wires (not shown) may connect the electrodes <NUM> to control circuitry (not shown) via the electrical contacts <NUM>. The wires may be disposed in lumens (not shown) of the elongated deflectable element <NUM> (<FIG>).

The flexible circuit strips <NUM> may have any suitable dimensions. For example, the length of the flexible circuit strips <NUM> may be in the range of <NUM> to <NUM>, e.g., <NUM>, the width of the flexible circuit strips <NUM> may be in the range of <NUM> to <NUM>, e.g., <NUM>, and the thickness of the flexible circuit strips <NUM> may be in the range of <NUM> to <NUM>.

Each flexible circuit strip <NUM> is labeled with a different letter or number <NUM>. In the example of <FIG>, each strip <NUM> is labeled with a different letter twice, once close to end <NUM> and once close to the other (tapered) end <NUM>. For example, a letter A is disposed close to the end <NUM> of one of the flexible circuit strips <NUM>, and another letter A is disposed close to the other end <NUM> of that strip <NUM>.

The symbols may be added during the circuit manufacturing process through standard lithographic methods such as etching, sputtering, plating, or direct laser marking. Each flexible circuit strips <NUM> may also include an alignment marking <NUM> (e.g., a line or other mark or symbol). Only some of the alignment markings <NUM> are labeled for the sake of simplicity.

Reference is now made to <FIG>, which is a schematic view of a single flexible circuit strip cut <NUM> from the panel <NUM> of <FIG>. The cut flexible circuit strips <NUM> may then be reinforced using the elongated resilient support elements <NUM> as well as connected to other elements and coverings as described in more detail with reference to <FIG>.

Reference is now made to <FIG>, which is a cross-sectional view through line A:A of <FIG>.

A yarn <NUM> may be run along the length of the elongated resilient support element <NUM> (<FIG>), e.g., formed from Nitinol or Polyethylenimine (PEI), and beyond so that the yarn <NUM> also runs the length of the hinge <NUM> (<FIG>). The elongated resilient support elements <NUM> may have any suitable thickness, for example, in the range of <NUM> to <NUM>. A covering <NUM>, such as a thermoplastic polymer resin shrink wrap (PET), may be placed over the yarn <NUM> and the elongated resilient support element <NUM>. Epoxy may be injected into the covering <NUM>. Heat may then be applied to the covering <NUM> thereby shrinking the covering <NUM> over the yarn <NUM> and the elongated resilient support element <NUM>. One reason to cover the elongated resilient support element <NUM> with the covering <NUM> is to electrically isolate the elongated resilient support element <NUM> from the circuit traces of the flexible circuit strip <NUM>. The covering <NUM> may be omitted, for example, if the elongated resilient support element <NUM> is covered with an insulating coating (e.g., polyurethane) or is comprised of an insulating material.

The flexible circuit strip <NUM> may then be placed over the yarn <NUM> and the elongated resilient support element <NUM> with the circuit trace side of the flexible circuit strip <NUM> facing the elongated resilient support element <NUM> and the electrode(s) <NUM> of the flexible circuit strips <NUM> facing away from the elongated resilient support element <NUM>. A covering <NUM> may then be disposed around the flexible circuit strip <NUM>, yarn <NUM>, and elongated resilient support element <NUM> combination, and epoxy <NUM> is injected into the covering <NUM>. The covering <NUM> may then be heated, thereby shrinking the covering <NUM> around the combination. The flexible circuit strips <NUM> are therefore covered with the covering <NUM>, e.g., a thermoplastic polymer resin shrink wrap (PET).

The yarn <NUM> may comprises any one or more of the following: an ultra-high-molecular-weight polyethylene yarn; or a yarn spun from a liquid-crystal polymer. The yarn <NUM> may be any suitable linear density, for example, in a range between <NUM> denier and <NUM> denier.

Reference is now made to <FIG>, which is a schematic view of a flexible circuit panel <NUM> with multiple copies of different symbol strips <NUM>. The flexible circuit panel <NUM> provides duplicate flexible circuit strips <NUM> (only some labeled for the sake of simplicity) on a single panel so that if one strip <NUM> is faulty, another one with the same symbol may be used instead. For example, <NUM> circuit strips <NUM> may be formed on a single flexible circuit panel with the strips <NUM> being labeled A through J (for example) again and again. The flexible circuit panel is then cut up. If one of the strips <NUM> marked "A" (for example) proves to be faulty, another "A" strip <NUM> may be used instead, and so on.

Reference is now made to <FIG> and <FIG>, which are schematic views of the catheter <NUM> of <FIG> showing the symbols <NUM> on the flexible circuit strips <NUM>.

<FIG> shows the nose connector <NUM> connected to the distal portion <NUM> of the pusher <NUM>. <FIG> and <FIG> show that the flexible circuit strips <NUM> are connected via the hinges <NUM> (only some labeled for the sake of simplicity) of the flexible circuit strips <NUM> to the nose connector <NUM>. The flexible circuit strips <NUM> are disposed circumferentially around the distal portion <NUM> of the pusher <NUM>, with first ends <NUM> (<FIG>) of the strips <NUM> being connected to an inner surface of the coupler <NUM>.

<FIG> shows the nose cap <NUM> (<FIG>) removed from the catheter <NUM> to illustrate how the flexible circuit strips <NUM> are connected to the nose connector <NUM>. The nose connector <NUM> includes a distal receptacle <NUM> having an inner surface <NUM> and a distal facing opening <NUM>. Second ends <NUM> (only some labeled for the sake of simplicity) of the strips <NUM> comprising the respective hinges <NUM> entering the distal facing opening <NUM> are connected to the inner surface <NUM> of the distal receptacle <NUM> of the nose connector <NUM>.

As previously mentioned with reference to <FIG>, the elongated resilient support elements <NUM> extend along inner surface of the respective strips <NUM> from the coupler <NUM> until before the respective hinges <NUM>. The hinge region may therefore be much thinner than the region including the elongated resilient support element <NUM>. The hinges <NUM> may have any suitable thickness, for example, in the range of <NUM> to <NUM> microns.

<FIG> also shows that the second ends <NUM> of the respective flexible circuit strips <NUM> are tapered along the width of the flexible circuit strips <NUM> to allow inserting the second ends <NUM> into the distal receptacle <NUM> without overlap. The hinges <NUM> may be connected to the inner surface <NUM> of the distal receptacle <NUM> using any suitable adhesive, for example, epoxy, and/or using any suitable connection method. As previously mentioned with reference to <FIG>, the hinges <NUM> of the flexible circuit strips <NUM> are supported with a length of yarn <NUM> (<FIG>), which typically runs the length of each respective flexible circuit strip <NUM>. <FIG> also shows a position sensor <NUM> disposed in the distal receptacle <NUM> of the nose connector <NUM>.

<FIG> and <FIG> show the distal end assembly <NUM> including the flexible circuit strips <NUM> with respective different symbol <NUM> (only some labeled for the sake of simplicity) marked thereon, and each strip <NUM> including electrode(s) <NUM> (<FIG>). The end <NUM> of each flexible circuit strip <NUM> is connected to the catheter coupler <NUM> with the flexible circuit strips <NUM> being ordered around a circumference of the catheter coupler <NUM> responsively to the respective symbols <NUM> of respective flexible circuit strips <NUM>. <FIG> also shows the alignment markings <NUM> (only some labeled for the sake of simplicity) used to align the flexible circuit strips <NUM> with the distal edge of the coupler <NUM>. When the coupler <NUM> is transparent or translucent, the alignment markings <NUM> may be aligned proximally to the distal edge of the coupler <NUM> (i.e. inside the coupler <NUM>) as the alignment marking <NUM> may then be seen from outside of the coupler <NUM>.

Reference is now made to <FIG>, which is a schematic view illustrating configuration and testing of the catheter <NUM> of <FIG>. The symbol <NUM> (e.g., the letter A shown in the inset <NUM>) allows a user to easily align a plane <NUM> of deflection of the catheter <NUM> with a deflection measurement element <NUM>, and/or to align the catheter <NUM> with a position tracking system <NUM>, which may include magnetic radiators aligned in a given configuration, and/or to easily select electrodes <NUM> (only some labeled) from among the different flexible circuit strips <NUM> (only some labeled) for testing.

Reference is now made to <FIG>, which is a flowchart <NUM> including steps in a method of manufacture and testing of the catheter <NUM> of <FIG>. Reference is also made to <FIG>. The method optionally includes connecting (block <NUM>) the coupler <NUM> to the elongated deflectable element <NUM>. The method includes forming (block <NUM>) the distal end assembly <NUM>. The step of block <NUM> includes forming (block <NUM>) the flexible circuit strips with respective different symbols <NUM> (<FIG>) marked thereon and optionally with respective alignment markings <NUM> (<FIG>), each strip including at least one respective electrode <NUM>. The step of block <NUM> may include forming (block <NUM>) the flexible circuit panel <NUM> (<FIG>) comprising the flexible circuit strips <NUM> in uncut form, and cutting (block <NUM>) the flexible circuit panel <NUM> to form the flexible circuit strips <NUM> as separated strips <NUM>. In some embodiments, the step of block <NUM> includes forming a flexible circuit panel <NUM> (<FIG>) with multiple copies of each of the symbols <NUM>. In other words, forming multiple identical flexible circuit strips <NUM>. The step of block <NUM> also includes attaching (block <NUM>) end <NUM> (<FIG>) of each flexible circuit strip <NUM> to the coupler <NUM> (and optionally the second end <NUM> (<FIG>) of each flexible circuit strip <NUM> to the nose connector <NUM> (<FIG>)) with the flexible circuit strips <NUM> being ordered around a circumference of the catheter coupler <NUM> responsively to the respective symbols <NUM> of respective flexible circuit strips <NUM>. In some embodiments, the attaching includes aligning end <NUM> of each flexible circuit strip <NUM> to the catheter coupler <NUM> responsively to the respective alignment markings <NUM> of the respective flexible circuit strips <NUM>.

As part of calibrating the catheter <NUM>, the method may include aligning (block <NUM>) the distal end assembly <NUM> with the position tracking system <NUM> (<FIG>) responsively to one or more of the symbols <NUM> of a respective one or more of the flexible circuit strips <NUM> (e.g., aligning the strip <NUM> marked A with an axis of one or more of the magnetic radiators of the position tracking system <NUM>), and performing (block <NUM>) a calibration of the catheter <NUM> with the position tracking system <NUM> responsively to the aligning.

As part of a testing procedure, the method may include aligning (block <NUM>) the plane <NUM> (<FIG>) of deflection of the distal end assembly <NUM> with the deflection measurement element <NUM> (<FIG>) responsively to one or more of the symbols <NUM> of a respective one or more of the flexible circuit strips <NUM>, deflecting (block <NUM>) the catheter <NUM> (e.g., fully deflecting the catheter <NUM>), and checking (block <NUM>) a deflection of the catheter <NUM> with the deflection measurement element <NUM>. As part of a testing procedure, the method may include checking (block <NUM>) a continuity of electrodes <NUM> of the catheter <NUM> responsively to respective ones of the symbols <NUM> of respective ones of the flexible circuit strips <NUM>.

Various features of the invention which are, for clarity, described in the contexts of separate embodiments may also be provided in combination in a single embodiment. Conversely, various features of the invention which are, for brevity, described in the context of a single embodiment may also be provided separately or in any suitable sub-combination.

Claim 1:
A catheter manufacturing method, comprising:
forming flexible circuit strips (<NUM>), each strip including respective different letters or numbers (<NUM>) marked thereon and at least one respective electrode (<NUM>);
attaching one end of each of the flexible circuit strips (<NUM>) to a catheter coupler (<NUM>) with the flexible circuit strips (<NUM>) being ordered around a circumference of the catheter coupler (<NUM>) in the order of the respective letters or numbers (<NUM>) of respective ones of the flexible circuit strips (<NUM>); and
forming a distal end assembly of a catheter (<NUM>), the distal end assembly comprising the flexible circuit strips (<NUM>) attached to the catheter coupler (<NUM>).