Abstract:
A guidable, or steerable, or deflectable catheter is provided that includes a proximal portion and a distal portion for insertion into a body cavity. A selectively deflectable segment having an anisotropic bending stiffness for deflection in individual planes is incorporated into the distal portion of the catheter shaft. The deflectable segment comprises a corrugate structure that provides smooth curvatures of desirable configurations, deflection planarity, and easiness.

Description:
BACKGROUND 
       [0001]    The instant disclosure relates to deflectable and steerable elongate devices, such as medical catheters. In particular, the instant disclosure relates to catheters having segments with anisotropic deflecting or bending stiffness that reduce or eliminate unintended out-of-plane movement of the catheter. 
         [0002]    Deflectable and steerable elongate devices such as catheters are used for an ever-growing number of medical, industrial, and manufacturing procedures. For example, catheters are used for diagnostic, therapeutic, and ablative procedures. During these procedures, a catheter is typically inserted into a vessel near the surface of the body and is guided to a specific location within the body for examination, diagnosis, and treatment. A catheter typically carries one or more energy emitting elements (e.g., electrodes, hyperthermic ablation elements, cryogenic elements, etc.), which may be used for tissue ablation, diagnosis, or the like. Some catheters perform only passive or diagnostic functions such as sensing the electrical waveforms of a beating heart. 
         [0003]    Catheters are often inserted into an artery or vein in the leg, neck, or arm of a patient and guided, sometimes with the aid of a guide wire or introducer, through the vessels until a distal end of the catheter reaches a desired location in the heart. Guidance of a catheter to a specific location in the body can be performed using feel, medical imaging (e.g., fluoroscopy), electrophysiological guidance (e.g., impedance-based and/or magnetic-based localization), computer generated maps/models, and/or various combinations of the above. In any case, it may be necessary to deflect or steer the distal end of the catheter to facilitate movement of the catheter through a body cavity (e.g., vessel) and/or to position the distal end of the catheter relative to an internal structure of interest. 
         [0004]    In this regard, guidable catheters and/or introducers typically include a selectively deflectable segment near their distal tip. For instance, an ablation catheter may include a distal end portion (e.g., insertion portion) having an ablation electrode and a relatively soft and flexible distal deflectable segment that is disposed between the electrode and a relatively more rigid (e.g., metallic wire-braided.) catheter shaft that extends to a proximal actuator. Pull wires may extend from a pull mechanism in the proximal actuator and attach to a pull ring positioned between the deflectable segment and the electrode, Upon manipulation of the actuator, the pull wires can generate a pull force that imposes a bending moment on the flexible deflectable segment. This can lead to the deflection of the distal end of the catheter, which allows the distal end to be routed to and/or positioned relative to the desired internal locations. 
         [0005]    One or more highly flexible polymer materials are typically used to construct a single or multi-segment deflectable body of the catheter. The catheter shaft proximally adjacent to the deflectable segment(s) typically consists of relatively rigid polymer materials. To improve the deflection planarity (i.e., in-plane deflection), prior catheters have incorporated various selectively deflectable segments or catheter bodies having anisotropic bending stiffness into deflectable segments or bodies of the catheters. Other catheters have used a “center strut” bonded to the deflecting portion to assist with maintaining catheter rigidity. See, e.g., U.S. patent application publication No. 2010/0063441, which is hereby incorporated by reference as though fully set forth herein. 
         [0006]    Difficulties with the aforementioned catheters include failing to systematically and synergistically consider axial curvatures, deflection easiness, deflection in-planarity, and elastic recovery after deflection. Deflection planarity and ease of deflection are highly desirable properties or features for a deflectable catheter. 
       BRIEF SUMMARY 
       [0007]    Among other things, various embodiments disclosed herein are directed to a family of deflectable or steerable and flexible devices such as medical catheters that facilitate movement of the distal tip of the device. 
         [0008]    According to a first aspect, a guidable catheter is provided. The catheter includes a catheter body that has a proximal portion and a distal portion where the distal portion is adapted for insertion into a body cavity (e.g., internal tissue lumen, blood vessel, etc.). A deflectable segment is incorporated into the distal portion of the catheter body. The deflectable segment may be interconnected (e.g., axially) to the proximal portion of the catheter body by one or more pull wires. Upon actuation of such pull wires the distal deflectable segment may be deflected to move/sweep the distal catheter tip within a virtual plane called a sweeping plane. 
         [0009]    The deflectable segment may be substantially tubular and may include a central lumen. Furthermore, the deflectable segment may have a first layer having a first corrugated surface and a second layer having a second corrugated surface. The first and second corrugated surface may be adjacent. The first corrugated surface may include a plurality of troughs and ridges, and the second corrugated surface may also include a second plurality of troughs and ridges. The first plurality of troughs and ridges may be complementary with the second plurality of troughs and ridges. In some embodiments, the first and second corrugated surfaces are bonded together. 
         [0010]    The deflectable bodies may be axially comprised of two corrugate tubes which can be converted to intimately bonded and interlocked-in-place tubular structures after manufacture. The corrugation may comprise a plurality of peaks  40  and troughs  41 , also referred to as radial ridges and troughs or valleys. The two corrugate tubes or layers for each deflectable body may be made of chemically compatible thermoplastic elastomer materials. In some embodiments, the corrugate tubes have different degrees of stiffness, flexibility or hardness. In addition, the corrugate tubes may have different melting or softening temperatures. The melting point of the first layer may differ from the melting point of the second layer by 20-30 degrees. In some embodiments, the first layer is Polyamide 12 and the second layer is a poly(ether block amide) copolymer. In at least one embodiment, the melting point of the first layer is greater than the melting point of the second layer. In at least one embodiment, the melting point of the first layer is less than the melting point of the second layer. 
         [0011]    In at least one embodiment of the invention, the catheter has a tip electrode disposed at the distal end of the catheter body. The tip electrode has an internal lumen which is aligned with and in communication with the central lumen of the deflectable segment. The catheter may also have a deflection actuating structure that includes an annular ring disposed between the distal portion of the deflectable segment and the tip electrode and first and second pull wires extending from the proximal portion of the catheter body and interconnected to the annular ring. The catheter may have a stiffening element disposed along a portion of a length of the deflectable segment. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0012]      FIG. 1  illustrates an exemplary catheter. 
           [0013]      FIG. 2  is a diagrammatic representation of a catheter in a neutral or non-deflected state. 
           [0014]      FIG. 3  is a diagrammatic representation of a catheter in a deflected state. 
           [0015]      FIG. 4A  illustrates a distal deflectable segment of an exemplary catheter in a neutral or non-deflected state. 
           [0016]      FIG. 4B  illustrates a distal deflectable segment of an exemplary catheter in a deflected state. 
           [0017]      FIG. 5  illustrates one example of a device having corrugated layers and a stiffening element. 
           [0018]      FIG. 6A  is across-sectional view taken along line  6 - 6  in  FIG. 5 .  FIG. 6B  is a cross-sectional view of another embodiment also taken along line  6 - 6  in  FIG. 5 . 
           [0019]      FIG. 7A  is a cross-sectional view taken along line  7 - 7  in  FIG. 5 .  FIG. 7B  is a cross-sectional view of another embodiment also taken along line  7 - 7  in  FIG. 5 . 
           [0020]      FIG. 8  illustrates an example of a device having corrugated layers. 
           [0021]      FIGS. 9-11  illustrate examples of different patterns of corrugation that can be used in a deflectable segment of an exemplary catheter. 
       
    
    
     DETAILED DESCRIPTION 
       [0022]    Various embodiments are described herein of various apparatuses, systems, and/or methods. Numerous specific details are set forth to provide a thorough understanding of the overall structure, function, manufacture, and use of the embodiments as described in the specification and illustrated in the accompanying drawings. It will be understood by those skilled in the art, however, that the embodiments may be practiced without such specific details. In other instances, well-known operations, components, and elements have not been described in detail so as not to obscure the embodiments described in the specification. Those of ordinary skill in the art will understand that the embodiments described and illustrated herein are non-limiting examples, and thus it can be appreciated that the specific structural and functional details disclosed herein may be representative and do not necessarily limit the scope of the embodiments, the scope of which is defined solely by the appended claims. 
         [0023]    Reference throughout the specification to “various embodiments,” “some embodiments,” “one embodiment,” or “an embodiment”, or the like, means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases “in various embodiments,” “in some embodiments,” “in one embodiment,” or “in an embodiment”, or the like, in places throughout the specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. Thus, the particular features, structures, or characteristics illustrated or described in connection with one embodiment may be combined, in whole or in part, with the features, structures, or characteristics of one or more other embodiments without limitation given that such combination is not illogical or non-functional. 
         [0024]    It will be appreciated that the terms “proximal” and “distal” may be used throughout the specification with reference to a physician manipulating one end of an instrument used to treat a patient. The term “proximal” refers to the portion of the instrument closest to the physician and the term “distal” refers to the portion located furthest from the physician. Similarly, “more proximal” means closer to the physician whereas “more distal” means further form the physician. It will be further appreciated that for conciseness and clarity, spatial terms such as “vertical,” “horizontal,” “up,” d “down” may be used herein with respect to the illustrated embodiments. However, surgical instruments may be used in many orientations and positions, and these terms are not intended to be limiting and absolute. 
         [0025]    The present disclosure is generally directed towards a family of medical devices having deflectable segments including corrugated layers. Exemplary embodiments of such devices are depicted in the figures. As described further below, use of a catheter having a distal deflectable segment having anisotropic bending properties allows for improved catheter guidance and/or improved control for tissue access and tissue contact. As used herein, a “catheter” means an elongated structure that can be inserted into and/or through a body cavity, duct, and/or vessel. In at least one embodiment, a catheter may be hollow and/or define a lumen therethrough for passing another medical device, such as a guidewire or another catheter, for example. However, in various embodiments, a catheter may be closed at least at its distal end. 
         [0026]    Referring now to the drawings wherein like reference numerals are used to identify identical or similar components in the various views,  FIG. 1  generally illustrates a deflectable electrophysiology catheter  3  that comprises a tubular body or shaft  21  extending from a proximal handle  20 . As used herein and commonly used in the art, the term “distal” is used generally to refer to components of the system, such as a tip electrode  13 , located toward the insertion end of the of the catheter  3  (i.e., toward the heart or other target tissue when the catheter is in use). In contrast, the term “proximal” is used generally to refer to components or portions of the system that are located or generally orientated toward the non-insertion end of the catheter (i.e., away from or opposite the heart or other target tissue when the catheter is in use). Catheter  3  may be used in any number of diagnostic and therapeutic applications, such as the recording of electrograms in the heart, the performance of a cardiac ablation procedure, and other similar applications/procedures. 
         [0027]    The proximal handle  20  includes an actuator  8  that is interconnected via one or more pull wires (not shown) to a distal deflectable segment  11  that is incorporated into the distal portion of the catheter  3 . In some embodiments it may be beneficial to constrain movement of the catheter tip to a consistent and repeatable plane when actuated by a pull wire in order to facilitate deflection movement of the distal tip of a catheter or other medical device. That is, upon pulling a pull wire (e.g., actuation) to deflect the distal tip of the catheter, the catheter tip may deflect within a sweeping plane that is repeatable from actuation to actuation. However, in extant devices, the tip of the catheter is often able to move out of the desired sweeping plane. That is, deflection of the distal tip of extant devices may not be consistent between actuations. Therefore, in some embodiments it may be beneficial to provide a distal deflectable segment that constrains the movement of the distal tip of the catheter in a predictable and consistent manner as described further below. 
         [0028]    As shown in  FIG. 1 , the distal tip of the exemplary catheter includes an ablation tip/electrode  13 . Located proximally behind the electrode  13  is a pull ring  12  and the distal deflectable segment  11 . The proximal end of the distal deflectable segment  11  is connected to the distal end of the catheter shaft  21 . Additional details regarding such a catheter may be found in U.S. patent application Ser. No. 13/838,124, incorporated by reference as though fully set forth herein. 
         [0029]      FIGS. 2 and 3  illustrate an enhanced view of the catheter  3 . The catheter  3  includes a tubular body or shaft  21  extending from the proximal handle  20 . Distal to the shaft  21  is a deflectable segment  111 . Between the shaft  21 , consisting of relatively rigid polymer(s), and the deflectable segment  111 , containing a softer polymer, is a shaft transition region  22  largely comprised of a polymer with an intermediate material rigidity. Connecting the deflectable segment  111  and a distal tip  24  is a distal transition region  23 .  FIG. 3  illustrates the deflectable segment  111  deflecting in the X-Y sweeping plane of deflection. 
         [0030]    Generally, the plane for deflection within which a deflectable segment has the greatest bending stiffness may define a reinforced plane of the segment. The plane for deflection within which the segment has the lowest bending stiffness may define a virtual, sweeping plane. The sweeping plane is typically perpendicular to the reinforced plane, and both planes pass through a reference, longitudinal axis (e.g., central X-axis in the neutral position) of the deflectable segment along its length. 
         [0031]      FIGS. 4A and 4B  illustrate an example of the distal deflectable segment according to the present teachings. As shown in  FIG. 4A , in a neutral, non-deflected state, the distal deflectable segment  211  extends, as a substantially tubular structure, between the distal end of a catheter shaft  10  and a tip electrode  13 . Generally, the catheter shaft  10  is more rigid than the distal deflectable segment  211 . For instance, the catheter shaft  10  may be formed of a flexible resilient material covered by a wire-braiding that may extend to a proximal handle  20  (not shown in  FIGS. 4A and 4B ). Such construction is well understood and need not be further described herein. 
         [0032]    In one exemplary embodiment, the shaft  10  is fabricated with a flexible resilient material. The shaft  10  can be fabricated of materials suitable for use in humans, such as biocompatible polymers. Suitable polymers include those well known in the art, such as numerous thermoplastics including, but not limited to, fluoropolymers, polyolefins, polyesters, polyamides, polycarbonate, polyurethanes, polyimides, polysulfones, polyketones, liquid crystal polymers and the like. Various thermoplastic elastomer (TPE) materials can also be selected, including, but not limited to, thermoplastic polyurethanes, polyamide-based TPE&#39;s, polyester-based TPE&#39;s, thermoplastic polyolefins, and styrenic TPE&#39;s. 
         [0033]    Located proximally behind the electrode  13  is a pull ring  12 . In order to deflect the deflectable segment  211 , pull wires (not shown) may extend from an actuator mechanism in a catheter handle (see, e.g., handle  20  shown in  FIG. 1 ) and attach to pull ring  12  located in the proximal vicinity of tip electrode  13 . 
         [0034]    As illustrated in  FIG. 4B , the distal tip (e.g., tip electrode  13 ) is caused to move within a bending or sweeping plane  100  (e.g., the X-Y plane). Such constraint to the desired sweeping plane may provide consistent and predictable displacement between deflections of the catheter. 
         [0035]    Previous deflectable segments have permitted some out-of-plane movement, which may be undesirable. To overcome these problems and minimize out-of-plane deflection, the distal deflectable segment  211  disclosed herein has anisotropic bending stiffness to facilitate the isolation of deflections of the segment  211  to a desired plane (e.g., the sweeping plane  100 ). As such, in its neutral position, the deflectable segment  211  has minimal bending moment of section bending stiffness about the Z-Z axis, which is perpendicular to the designated sweeping plane of deflection, namely the X-Y plane. 
         [0036]    As shown in  FIG. 5 , the deflectable segment  211  comprises interlocking, corrugated tubular structures that provide smooth curvatures of desirable configurations, deflection planarity and manipulation easiness. The corrugated structures for the segment  211  also lead to decreased kinking tendency and allow for high torque transfer from the shaft  10  to the tip electrode  13 . 
         [0037]      FIG. 5  illustrates a delectable segment  211  that includes two corrugated layers,  14  and  15 . The deflectable segment  211  includes a first corrugated inner layer  15  and a second corrugated outer layer  14 . Layers  14  and  15  can be made of chemically compatible thermoplastic elastomer materials. Layers  14  and  15  have different stiffness (or flexibility or hardness) and may further have different melting (or softening) temperatures. Thermoplastic elastomer materials can be selected from commercially available poly(ether-block-amide) copolymers (such as Pebax® and Vestamid® E), the thermoplastic polyurethane elastomers (such as Pellethane®, Tecoflex®, Tecoplast®, Tecothane®, Carbothane®, Elasthane®, Bionate®, Biospan®, Pursil®, and Carbosil®), polyester-based thermoplastic elastomers such as Hytrel® and Arnitel®), polyamides (PA11, PA12, PA612, etc.), polyesters such as PET and PBT, poly(bisphenol A carbonate), and the like. In some embodiments, the thermoplastic elastomer material is selected from PA11, PA12, and PA612. 
         [0038]    To manufacture the deflectable segment  211 , the inner layer  15 , which may have either consistent and uniform corrugation patterns or axially varying patterns (for example, as shown in  FIG. 11 ), can be prepared from a polymer having a higher melting (or softening) temperature than the outer layer  14  using injection molding, compression molding, or 3D printing. The inner layer  15  will form a corrugated tubular structure having a central lumen  30 . The second outer layer  14  can be pre-extruded into tubing from other polymer having a lower melting (or softening) temperature than the inner layer  15 , and then applied onto the pre-molded inner layer  15 . Upon thermal fusion or reflow processes, the outer layer  14  will fill into the valleys of the corrugated inner layer  15 , and adhere onto the corrugated surfaces of the inner layer  15 . In the end, the layers  14  and  15  will be integrated into an inseparable deflectable segment. The corrugations of layer  14  will be complementary to the corrugations of layer  15 , but it should be understood that the term “complementary” does not mean that there are no gaps between the corrugations of layers  14  and  15 . Indeed, it is contemplated that interstitial spaces will remain between layers  14  and  15 . 
         [0039]    To facilitate bonding of layers  14  and  15 , in some embodiments, a shrink tubing may be applied onto the second outer layer  14 , and a metallic rod may be inserted into the lumen  30  of the inner layer  15 . Upon uniform heating onto the shrink tube, the outer layer  14  melts and fills into the corrugations of the inner layer  15  under the inwards shrink pressure arising from the shrink tube, while the metallic rod preserves the integrity of central lumen  30 . During the processes, the pre-molded inner layer  15  remains in its solid state because of its higher melting point. 
         [0040]    To achieve suitable thermal fusion between the pre-molded inner layer  15  and the pre-extruded outer layer  14 , the melting (or softening) temperature for the inner layer  15  should be at least 10° C. higher than that of the outer layer  14 . In sonic embodiments, the melting (or softening) temperature for the inner layer is about 20-30° C. greater than that of the outer layer  14 . For example, PA12 having a melting temperature ranging from 175 to 180° C. can be used for the inner layer  15 , while a poly(ether block amide) copolymer (PEBA), such as Pebax®) 5533 SA 01 (having the melting temperature of about 160° C.) or Pebax® 4033 SA 01 (having the melting temperature of about 147° C.), or Pebax® 3533 SA 01 (having the melting temperature of about 144° C.) can be used as the outer layer  14 . 
         [0041]    In another example, the inner layer  15  can be made of Pebax® 7233 SA 01 and the outer layer  14  can be made of Pebax® 4033 SA 01 or Pebax® 3533 SA 01 or Pebax® 2533 SA 01. 
         [0042]    In another example, the inner layer  15  is made of PA11, and the outer layer  14  is made of a polytetramethylene glycol based polyurethane elastomer such as Pellethane® 2363-90AE or Pellethane® 2363-80AE. 
         [0043]    In another embodiment, the polymers of inner layer  15  and outer layer  14  can be selected to have distinctly different hardness but similar softening temperatures for melt processing. In such embodiments, a highly flexible elastomeric adhesive layer, such as proper urethane adhesives and silicone adhesives, can be introduced between the inner layer  15  and outer layer  14  to fill in any gaps between the complementary peaks (or ridges) and troughs (or valleys) of layers  15  and  14 . The curing temperature for the adhesives should not soften the body materials. 
         [0044]    As shown in  FIG. 5 , the deflectable segment  211  can have a stiffening element  16  such as those disclosed in U.S. Pat. No. 7,985,215, which is hereby incorporated in its entirety by reference. The stiffening element  16  has a Young&#39;s modulus greater than the Young&#39;s modulus of the surrounding material of the deflectable segment  211 . 
         [0045]    The stiffening element  16  may extend over the entirety of the length of the deflectable segment  211  and/or multiple stiffening elements  16  may be disposed in, for example, series and/or parallel. In one arrangement, stiffening elements  16  have a Young&#39;s modulus that is greater than the Young&#39;s modulus of the material forming the deflectable segment  211 . In such an arrangement, stiffening elements  16  may be formed of for example, relatively rigid polymeric material and/or metallic material. In any arrangement, the cross section of a stiffening element  16  may have an area moment of inertia about a first centroidal axis that is greater than an area moment of inertia about a second centroidal axis. In this regard, the stiffening element  16  may permit bending or deflection in a plane in parallel with the first centroidal axis, while significantly restricting bending in another plane. Accordingly, such a stiffening element  16  may be disposed in the vicinity of a reinforced plane of a distal deflectable segment  211  to prevent out-of-plane movement while permitting in-plane movement (e.g., sweeping plane movement). 
         [0046]      FIGS. 6A, 6B, 7A, and 7B  show various cross-sections of deflectable segment  211 , depicted in  FIG. 5 , including stiffening elements  16 . In  FIGS. 6A and 7A , the stiffening element  16  is a separate, rigid and thin center element that can be inserted and integrated into the inner layer  15  as disclosed in U.S. Pat. No. 7,985,215. The stiffening element  16  helps improve the deflection planarity within the sweeping plane, i.e., XY plane. The stiffening element  16  as shown in  FIGS. 6A and 7A  can be made of a rigid thermoplastic having a higher hardness than either layer  15  or layer  14 . In some embodiments, the stiffening element  16  is a thin sheet metal. In an alternative embodiment depicted in  FIGS. 6B and 7B , the stiffening element  16  is part of the pre-molded inner layer  15 . 
         [0047]    Thus, stiffening element  16  can be made of metals or metallic alloys commonly used for reinforcing catheter shafts, including steels, stainless steels, NiTi alloys, tungsten, and others. Also, those stiffening materials can be engineering polymers such as polycarbonates, nylons, polyesters, polyurethanes, nylon-based copolymers, polystyrenes, poly(methyl methacrylate), polysulfones, liquid crystalline polymers, and the like. 
         [0048]    The stiffening element  16  is placed near a neutral in-plane bending axis, i.e., Z-axis. Therefore, the stiffening element  16  has minimal contribution to the in-plane bending stiffness about the neutral in-plane bending axis, i.e., Z-axis. However, due to the high Young&#39;s modulus of the stiffening element  16 , the stiffening element  16  increases the out-of-plane bending stiffness about the neutral out-of-plane bending axes, i.e., X-axis and Y-axis. 
         [0049]      FIG. 8  shows a deflectable segment  311  having at least one metal braid assembly  18  axially extending into part or all of the deflectable segment  311 . The metal braid assembly  18  may be a braided wire mesh. The metal braid assembly  18  may be formed of stainless steel wire. The metal braid assembly may be formed separately on a disposable core and slipped about inner layer  15  of the deflectable segment. Those of skill in the art will be familiar with the use of braid assembly  18  in catheter construction, and thus it need not be described further herein. 
         [0050]      FIGS. 9-11  illustrate a variety of possible contours for the corrugated, inner layer  15  of the deflectable body  211 . The corrugation can take various regular or irregular geometries such as semi-circular, rectangular, triangular, trapezoidal, sinusoidal, wave-like, and the like.  FIG. 9  represents a semi-circle variation,  FIG. 10  represents a rectangular variation, and  FIG. 11  represents an altered axial repeating pattern. As shown, the corrugation profile can remain uniform throughout deflectable segment  211  or may vary axially. If it varies, it may be a repeating pattern or a non-repetitive design. 
         [0051]    Although several embodiments of this disclosure have been described above with a certain degree of particularity, those skilled in the art could make numerous alterations to the disclosed embodiments without departing from the scope of this disclosure. All directional references (e.g., upper, lower, upward, downward, left, right, leftward, rightward, top, bottom, above, below, vertical, horizontal, clockwise, and counterclockwise) are only used for identification purposes to aid the reader&#39;s understanding of the present disclosure, and do not create limitations, particularly as to the position, orientation, or use of the embodiments of the disclosure. Joinder references (e.g., attached, coupled, connected, and the like) are to be construed broadly and may include intermediate members between a connection of elements and relative movement between elements. As such, joinder references do not necessarily infer that two elements are directly connected and in fixed relation to each other. 
         [0052]    It is intended that all matter contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative only and not limiting. Changes in detail or structure may be made without departing from the spirit of the disclosure as defined in the appended claims. 
         [0053]    Any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated materials does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.