Patent Description:
Intravascular catheters are used in a variety of different treatment and diagnostic procedures to advance and position therapeutic devices to target locations within the body. Reaching such target locations may involve navigating tortuous vascular pathways having extreme turning or bending radiuses and/or dimensions making access difficult for typical catheters. While there are a large number of vascular catheters and microcatheters designed to enable access to different anatomical locations in the vasculature, a key issue that small diameter catheter designs face is providing a combination of desirable pushability, fine torqueability response, axial strength stability, maintaining lumen concentricity, resistance to catheter body plastic deformation or catheter body fatigue and desired variable flexibility across the length of the catheter. Providing and controlling such characteristics is important in order to enable a physician to negotiate access through various complex and often tortuous, anatomical vasculature in the cardiovascular, peripheral vascular, or neurovascular systems to deliver other adjunctive devices, imaging contrasts, aspirate, and other therapeutic agents.

There remains a need for improved designs for such catheters, and more generally, alternative designs for catheter tubes and substructures that allow not only ease of fabrication, but also design control of various characteristics of the components of a catheter, including steerability, torqueability, variable bending flexibility along the working length, pushability, lumen collapse or kink resistance, axial pull strength, tip to catheter body transition compliance, etc., at any point along the catheter.

<CIT> discloses a catheter with a zone comprising a cut pattern segment defining a plurality of spiral cuts with a width of <NUM>, a pitch of <NUM> and a zone diameter of approximately <NUM>. <CIT> discloses a catheter with a spiral cut.

The present disclosure provides a catheter as described in claim <NUM>, including a catheter tube defining: a proximal end; a distal end; a longitudinal axis; a lumen therethrough; and a first zone having a first cut pattern segment therein. The first cut pattern segment defines a plurality of spiral cuts spaced around a circumference of the tube, where each of the plurality of spiral cuts defines a width between <NUM> and <NUM>, where each of the plurality of spiral cuts is spaced from an adjacent cut by a filar having a width between <NUM> and <NUM>, and where each of the plurality of spiral cuts defines a pitch angle with the longitudinal axis between <NUM> degrees and <NUM> degrees. The first zone may have a stiffness between approximately <NUM> gF/mm and approximately <NUM> gF/mm. The plurality of spiral cuts may include between <NUM> and <NUM> cuts. The first zone may have a length between <NUM> and <NUM>. The catheter tube may be constructed from a nitinol and may have a wall thickness between approximately <NUM> and approximately <NUM>. The catheter tube may be constructed from an inconel and may have a wall thickness between approximately <NUM> and approximately <NUM>. The catheter tube may be constructed from stainless steel and may have a wall thickness between approximately <NUM> and approximately <NUM>.

The distal end may include a tip segment having a plurality of helical segments extending around the longitudinal axis. Each helical segment may include two substantially parallel filars connected at distal ends thereof. The plurality of helical segments may include at least <NUM> helical segments.

The catheter may include a polymer liner disposed within the lumen and/or a polymer jacket disposed around the outer diameter of the cut tube.

The catheter tube may include a second zone having a second cut pattern segment therein, where the second cut pattern segment defines a plurality of cuts spaced around a circumference of the tube, where each of the plurality of cuts defines a width between <NUM> and <NUM>, where each of the plurality of cuts is spaced from an adjacent cut by a filar having a width between <NUM> and <NUM>, and where each of the plurality of cuts defines a pitch angle with the longitudinal axis between <NUM> degrees and <NUM> degrees.

The second zone may be located proximal of the first zone and/or have a stiffness between approximately <NUM> gF/mm and approximately <NUM> gF/mm. The plurality of cuts of the second cut pattern segment may include between <NUM> and <NUM> cuts. The second zone may have a length between <NUM> and <NUM>.

A more complete understanding of the present disclosure, and the attendant advantages and features thereof, will be more readily understood by reference to the following detailed description when considered in conjunction with the accompanying drawings wherein:.

The present disclosure provides improved designs for catheter constructions, and more generally, alternative designs for catheter tubes and substructures that allow not only ease of fabrication, but also control and improvement of various characteristics of the components definable along the length of a catheter, providing a combination of desirable pushability, including steerability, fine torqueability response, axial pull strength, maintaining lumen stability and concentricity, using variable bending stiffness and flexibility along the catheter working length, circumferential collapse or kink bend resistance, resistance to catheter body plastic deformation or catheter body fatigue, etc., at any point along the catheter.

Now referring to the figures, <FIG> illustrate examples of the device and component embodiments of an intravascular medical device <NUM>, such as a catheter, constructed in accordance with the principles and advantages disclosed herein. The device <NUM> is a minimally-invasive device that can be introduced and operated percutaneously and intravascularly in conjunction with one or more other devices as disclosed herein, such as those used in interventional radiology, cardiology, and neuroradiologically to assess and/or treat occlusions, obstructions or other vascular defects, malformations and or conditions. Examples of the medical device <NUM> include but are not limited to catheters, micro catheters, balloon catheters, guide catheters, guide catheter extensions, dual lumen catheters, dissection and or subintimal re-entry catheters, aspiration catheters, device delivery catheters for vascular and structural heart valves, stent-grafts, stents, or vascular filters or the like. The medical device may be configured for passage in and through neurovascular, coronary, peripheral, and/or arterial pathways, and may also be configured for non-vascular endoscopic and/or laparoscopic applications.

The device <NUM> generally includes an elongated catheter body <NUM> with sufficient length, flexibility, and torqueability characteristics to be introduced and operated from an exterior of the patient, traverse the vasculature, and be positioned proximate the region being assessed or treated. The catheter body <NUM> generally includes a proximal segment <NUM> that may connect to and/or terminate at a hub or other component exterior to a patient, and a distal segment <NUM> (which may be fabricated from one continuous length of definable segments). The catheter body <NUM> further includes or defines a lumen <NUM> extending therethrough and exiting at the distal segment <NUM>, where the lumen <NUM> has a diameter sufficient to pass a guidewire or other interventional devices such as coils or embolic materials therethrough and/or to introduce one or more other medical instruments or devices through the catheter body <NUM>. The catheter body <NUM> may generally define a longitudinal axis <NUM> along a length thereof.

The catheter body <NUM> may be constructed at least in part from a polymer or metallic tube, hypotube, or other tubular or cylindrical construct having one or more segments constructed from metal, nitinol, stainless steel, polymers, polymer compositions and/or other materials and composites thereof. The catheter body <NUM> may constitute a unitary, single-piece construction, or may be modular and include multiple components of similar or varied composition of materials assembled, attached, or otherwise coupled together to form the body <NUM>. Additional features of the device <NUM> and the catheter body <NUM> are provided in <CIT> (<CIT>), entitled 'MODULAR VASCULAR CATHETER,' and <CIT> (<CIT>), entitled 'VARIABLE FLEXIBILITY CATHETER SUPPORT FRAME.

The catheter body <NUM> may include one or more zones 22a, 22b, 22c. 22z (collectively referred to as '<NUM>') along a length thereof that provide varying characteristics related to steerability, torqueability, variable bending flexibility, pushability, collapse or kink resistance, catheter shaft fatigue or resistance to plastic deformability, or the like. Each zone <NUM> may, for example, have varying multi-filar cut patterns, length, spacing between cut pattern segments, wall construction, material composition, or other design features different than the other zones <NUM> to provide a desired functionality of the device <NUM>. The catheter body <NUM> may also be referred to, at least in part, as a catheter tube <NUM>.

Each zone <NUM> may include one or more cut pattern segments 24a, 24b, 24c. 24z (collectively referred to as '<NUM>') extending along a length thereof. The cut pattern segments <NUM> within a particular zone <NUM> may be substantially similar to other cut patterns or cut pattern segments <NUM> within that zone or may vary to provide a range of functional, progressive characteristics in distal or proximal directions within a single zone <NUM>.

Each cut pattern segment <NUM> may include a cut pattern therein having a plurality of cuts or material otherwise removed or absent from the catheter body to provide a desired functionality of the device <NUM>. For example, a cut pattern segment <NUM> may include or define a plurality of circumferentially spaced cuts 26a, 26b, 26c. 26z (collectively referred to as '<NUM>'). The cuts <NUM> within a cut pattern segment <NUM> may be substantially similar to one another, or may vary within a single cut pattern segment <NUM>. Each cut <NUM> may define a pitch angle α with respect to a pitch axis <NUM> and the longitudinal axis <NUM> of the catheter body <NUM>, and may define a cut width <NUM> as measured perpendicular to the pitch angle axis. The direction of the pitch of the cuts <NUM> may vary amongst cut pattern segments <NUM> (i.e., counterclockwise vs. clockwise rotation of the pitch, as shown in <FIG>), and the quantity of the cuts <NUM> within the circumference of a particular cut pattern segment <NUM> may also vary to provide the desired characteristics in a zone <NUM> and the spiral length of cut relative to the longitudinal axis or segment length.

Each cut pattern segment <NUM> may include a plurality of uncut portions or filars 30a, 30b, 30c. 30z (collectively referred to as '<NUM>') between the cuts <NUM> to provide a desired functionality of the device <NUM>. The filars <NUM> within a cut pattern segment <NUM> may be substantially similar to one another, or may vary within a single cut pattern segment <NUM>. Each filar <NUM> may have the same pitch angle α as the cuts <NUM> with respect to the longitudinal axis <NUM> of the catheter body <NUM>, and may define a filar width <NUM> as measured perpendicular to the pitch angle axis. The direction of the pitch of the filars <NUM> may vary amongst cut pattern segments <NUM> (i.e., counterclockwise vs. clockwise rotation of the pitch), and the quantity of the filars <NUM> within the circumference of a particular cut pattern segment <NUM> may also vary to provide the desired characteristics in a zone <NUM>. The disclosed multi-filar feature provides improved axial pull strength compared to prior art mono-filar or filament designs, among other benefits and improved function disclosed herein.

The catheter body <NUM> may include or define an uncut segment <NUM> positioned longitudinally between successive or adjacent pluralities of cuts <NUM>. The uncut segment <NUM> may define a length <NUM> as measured along the longitudinal axis <NUM> to form an uncut region or ring in between successive or adjacent pluralities of cuts <NUM>. The uncut segment(s) <NUM> may be composed of an interruption from one cut pattern to the next. For example, these interrupted cut segments may occur repeatedly along the length of the body <NUM> at substantially the same circumferential location about the center axis and restart the inline cut pattern into the next adjacent cut segment.

Each cut pattern segment <NUM> may define a length <NUM> as measured along the longitudinal axis <NUM>, where the length <NUM> includes the length of the plurality of cuts <NUM> therein and half of each bordering uncut segment length <NUM> on either side of the cuts <NUM>.

In one example, the catheter body <NUM> may include a first zone 22a at or near the distal portion of the medical device <NUM>. The first zone 22a may include at least one cut pattern segment 24a having a plurality of circumferentially-spaced cuts <NUM> having a cut width between <NUM> and <NUM>, and may preferably be approximately <NUM>. The first zone 22a may define a plurality of circumferentially-spaced filars <NUM> having a width between <NUM> and <NUM>, and may preferably be approximately <NUM>.

The plurality of cuts <NUM> and the plurality of filars <NUM> may each have a pitch angle α between <NUM> degrees and <NUM> degrees, and may preferably be approximately <NUM> degrees. The cut pattern segment 24a may include between <NUM> and <NUM> cuts, and between <NUM> and <NUM> filars. The cut pattern segment 24a may preferably include <NUM> cuts, and <NUM> filars.

The first zone 22a may include a plurality of cut pattern segments having the dimensions specified above. The number of cut pattern segments in the first zone 22a may be between <NUM> and <NUM>. Each cut pattern segment of the first zone 22a has a segment length between <NUM> and <NUM>, and may preferably be approximately <NUM>. The first zone 22a may include a plurality of uncut segments <NUM>, with each uncut segment <NUM> defining an uncut segment length between <NUM> and <NUM>, and may preferably be approximately <NUM>.

This first zone 22a may have an average flexibility between approximately <NUM> gF/mm and approximately <NUM> gF/mm.

Continuing in this example of an exemplary medical device, the catheter body <NUM> may include a second zone 22b located proximal of the first zone 22a. The second zone 22b may include at least one cut pattern segment 24b having a plurality of circumferentially-spaced cuts <NUM> having a cut width between <NUM> and <NUM>, and may preferably be approximately <NUM>. The second zone 22b may define a plurality of circumferentially-spaced filars <NUM> having a width between <NUM> and <NUM>, and may preferably be approximately <NUM>.

The plurality of cuts <NUM> and the plurality of filars <NUM> may each have a pitch angle α between <NUM> degrees and <NUM> degrees, and may preferably be approximately <NUM> degrees. The cut pattern segment 24b may include between <NUM> and <NUM> cuts, and between <NUM> and <NUM> filars. The cut pattern segment 24b may preferably include <NUM> cuts, and <NUM> filars.

The second zone 22b may include a plurality of cut pattern segments having the dimensions specified above. The number of cut pattern segments in the second zone 22b may be between <NUM> and <NUM>. Each cut pattern segment of the second zone 22b has a segment length between <NUM> and <NUM>, and may preferably be approximately <NUM>. The second zone 22b may include a plurality of uncut segments <NUM>, with each uncut segment <NUM> defining an uncut segment length between <NUM> and <NUM>, and may preferably be approximately <NUM>.

This second zone 22b may have an average flexibility between approximately <NUM> gF/mm and approximately <NUM> gF/mm.

Continuing in this example, the catheter body <NUM> may include a third zone 22c located proximal of the second zone 22b. The third zone 22c may include at least one cut pattern segment 24c having a plurality of circumferentially-spaced cuts <NUM> having a cut width between <NUM> and <NUM>, and may preferably be approximately <NUM>. The third zone 22c may define a plurality of circumferentially-spaced filars <NUM> having a width between <NUM> and <NUM>, and may preferably be approximately <NUM>.

The plurality of cuts <NUM> and the plurality of filars <NUM> may each have a pitch angle α between <NUM> degrees and <NUM> degrees, and may preferably be approximately <NUM> degrees. The cut pattern segment 24c may include between <NUM> and <NUM> cuts, and between <NUM> and <NUM> filars. The cut pattern segment 24c may preferably include <NUM> cuts, and <NUM> filars.

The third zone 22c may include a plurality of cut pattern segments having the dimensions specified above. The number of cut pattern segments in the third zone 22c may be between <NUM> and <NUM>. Each cut pattern segment of the third zone 22c has a segment length between <NUM> and <NUM>, and may preferably be approximately <NUM>. The third zone 22c may include a plurality of uncut segments <NUM>, with each uncut segment <NUM> defining an uncut segment length between <NUM> and <NUM>, and may preferably be approximately <NUM>.

This third zone 22c may have an average flexibility between approximately <NUM> gF/mm and approximately <NUM> gF/mm.

In one example, the catheter body <NUM> may have an inner diameter between <NUM> and <NUM>, and outer diameter between <NUM> and <NUM>, and/or a wall thickness between <NUM> and <NUM>. Variations of the dimensions and patterns described herein may be incorporated into devices of all applicable inner and outer diameters, including those ranging from <NUM> French to <NUM> French.

In one example, the catheter body <NUM> may have an inner diameter between <NUM> and <NUM>, and outer diameter between <NUM> and <NUM>, and/or a wall thickness between <NUM> and <NUM>.

In another example, the catheter body <NUM> may have an inner diameter between <NUM> and <NUM>, and outer diameter between <NUM> and <NUM>, and/or a wall thickness between <NUM> and <NUM>. Variations of the dimensions and patterns described herein may be incorporated into devices of all applicable inner and outer diameters, including those ranging from <NUM> French to <NUM> French.

In this example, the catheter body <NUM> may include a first zone 22a at or near the distal portion of the medical device <NUM>. The first zone 22a may include at least one cut pattern segment 24a having a plurality of circumferentially-spaced cuts <NUM> having a cut width between <NUM> and <NUM>, and may preferably be approximately <NUM>. The first zone 22a may define a plurality of circumferentially-spaced filars <NUM> having a width between <NUM> and <NUM>, and may preferably be approximately <NUM>.

The second zone 22b may include a plurality of cut pattern segments having the dimensions specified above. The number of cut pattern segments in the second zone 22b may be between <NUM> and <NUM>. Each cut pattern segment of the second zone 22b has a segment length between <NUM> and <NUM>, and may preferably be approximately <NUM>. The second zone 22b may include a plurality of uncut segments <NUM>, with each uncut segment <NUM> defining an uncut segment length between <NUM> and. <NUM>, and may preferably be approximately <NUM>.

Continuing in this example, the catheter body <NUM> may include a third zone 22c located proximal of the second zone 22b. The third zone 22c may include at least one cut pattern segment 24c having a plurality of circumferentially-spaced cuts <NUM> having a cut width between between <NUM> and <NUM>, and may preferably be approximately <NUM>. The third zone 22c may define a plurality of circumferentially-spaced filars <NUM> having a width between <NUM> and <NUM>, and may preferably be approximately <NUM>.

Continuing in this example of an exemplary medical device, the catheter body <NUM> may include a fourth zone 22d located proximal of the first zone 22a. The fourth zone 22d may include at least one cut pattern segment 24d having a plurality of circumferentially-spaced cuts <NUM> having a cut width between <NUM> and <NUM>, and may preferably be approximately <NUM>. The fourth zone 22b may define a plurality of circumferentially-spaced filars <NUM> having a width between <NUM> and <NUM>, and may preferably be approximately <NUM>.

The plurality of cuts <NUM> and the plurality of filars <NUM> may each have a pitch angle α between <NUM> degrees and <NUM> degrees, and may preferably be approximately <NUM> degrees. The cut pattern segment 24d may include between <NUM> and <NUM> cuts, and between <NUM> and <NUM> filars. The cut pattern segment 24d may preferably include <NUM> cuts, and <NUM> filars.

The fourth zone 22d may include a plurality of cut pattern segments having the dimensions specified above. The number of cut pattern segments in the fourth zone 22d may be between <NUM> and <NUM>. Each cut pattern segment of the fourth zone 22d has a segment length between <NUM> and <NUM>, and may preferably be approximately <NUM>. The fourth zone 22d may include a plurality of uncut segments <NUM>, with each uncut segment <NUM> defining an uncut segment length between <NUM> and <NUM>, and may preferably be approximately <NUM>.

This fourth zone 22b may have an average flexibility between approximately <NUM> gF/mm and approximately <NUM> gF/mm.

Continuing in this example, the catheter body <NUM> may include a fifth zone 22e located proximal of the fourth zone 22e. The fifth zone 22e may include at least one cut pattern segment 24e having a plurality of circumferentially-spaced cuts <NUM> having a cut width between <NUM> and <NUM>, and may preferably be approximately <NUM>. The fifth zone 22e may define a plurality of circumferentially-spaced filars <NUM> having a width between <NUM> and <NUM>, and may preferably be approximately <NUM>.

The plurality of cuts <NUM> and the plurality of filars <NUM> may each have a pitch angle α between <NUM> degrees and <NUM> degrees, and may preferably be approximately <NUM> degrees. The cut pattern segment 24e may include between <NUM> and <NUM> cuts, and between <NUM> and <NUM> filars. The cut pattern segment 24e may preferably include <NUM> cuts, and <NUM> filars.

The fifth zone 22e may include a plurality of cut pattern segments having the dimensions specified above. The number of cut pattern segments in the fifth zone 22e may be between <NUM> and <NUM>. Each cut pattern segment of the fifth zone 22e has a segment length between <NUM> and <NUM>, and may preferably be approximately <NUM>. The fifth zone 22e may include a plurality of uncut segments <NUM>, with each uncut segment <NUM> defining an uncut segment length between <NUM> and <NUM>, and may preferably be approximately <NUM>.

This fifth zone 22e may have an average flexibility between approximately <NUM> gF/mm and approximately <NUM> gF/mm.

Continuing in this example of an exemplary medical device, the catheter body <NUM> may include a sixth zone 22f located proximal of the fifth zone 22e. The sixth zone 22f may include at least one cut pattern segment 24f having a plurality of circumferentially-spaced cuts <NUM> having a cut width between <NUM> and <NUM>, and may preferably be approximately <NUM>. The sixth zone 22f may define a plurality of circumferentially-spaced filars <NUM> having a width between <NUM> and <NUM>, and may preferably be approximately <NUM>.

The plurality of cuts <NUM> and the plurality of filars <NUM> may each have a pitch angle α between <NUM> degrees and <NUM> degrees, and may preferably be approximately <NUM> degrees. The cut pattern segment 24f may include between <NUM> and <NUM> cuts, and between <NUM> and <NUM> filars. The cut pattern segment 24f may preferably include <NUM> cuts, and <NUM> filars.

The sixth zone 22f may include a plurality of cut pattern segments having the dimensions specified above. The number of cut pattern segments in the sixth zone 22f may be between <NUM> and <NUM>. Each cut pattern segment of the sixth zone 22f has a segment length between <NUM> and <NUM>, and may preferably be approximately <NUM>. The sixth zone 22f may include a plurality of uncut segments <NUM>, with each uncut segment <NUM> defining an uncut segment length between <NUM> and <NUM>, and may preferably be approximately <NUM>.

This sixth zone 22f may have an average flexibility between approximately <NUM> gF/mm and approximately <NUM> gF/mm.

Continuing in this example, the catheter body <NUM> may include a seventh zone <NUM> located proximal of the sixth zone 22f. The seventh zone <NUM> may include at least one cut pattern segment <NUM> having a plurality of circumferentially-spaced cuts <NUM> having a cut width between <NUM> and <NUM>, and may preferably be approximately <NUM>. The seventh zone <NUM> may define a plurality of circumferentially-spaced filars <NUM> having a width between <NUM> and <NUM>, and may preferably be approximately <NUM>.

The plurality of cuts <NUM> and the plurality of filars <NUM> may each have a pitch angle α between <NUM> degrees and <NUM> degrees, and may preferably be approximately <NUM> degrees. The cut pattern segment <NUM> may include between <NUM> and <NUM> cuts, and between <NUM> and <NUM> filars. The cut pattern segment <NUM> may preferably include <NUM> cuts, and <NUM> filars.

The seventh zone <NUM> may include a plurality of cut pattern segments having the dimensions specified above. The number of cut pattern segments in the seventh zone <NUM> may be between <NUM> and <NUM>. Each cut pattern segment of the seventh zone <NUM> has a segment length between <NUM> and <NUM>, and may preferably be approximately <NUM>. The seventh zone <NUM> may include a plurality of uncut segments <NUM>, with each uncut segment <NUM> defining an uncut segment length between <NUM> and <NUM>, and may preferably be approximately <NUM>.

This seventh zone <NUM> may have an average flexibility between approximately <NUM> gF/mm and approximately <NUM> gF/mm.

This fourth zone 22d may have an average flexibility between approximately <NUM> gF/mm and approximately <NUM> gF/mm.

Continuing in this example, the catheter body <NUM> may include a third zone 22c located proximal of the second zone 22b. The third zone 22c may include at least one cut pattern segment 24c having a plurality of circumferentially-spaced cuts <NUM> having a cut width between <NUM> and <NUM>, and may preferably be approximately <NUM>. The third zone 22c may define a plurality of circumferentially-spaced filars <NUM> having a width between <NUM> and <NUM>, and may preferably be approximately <NUM>. The plurality of cuts <NUM> and the plurality of filars <NUM> may each have a pitch angle α between <NUM> degrees and <NUM> degrees, and may preferably be approximately <NUM> degrees. The cut pattern segment 24c may include between <NUM> and <NUM> cuts, and between <NUM> and <NUM> filars. The cut pattern segment 24c may preferably include <NUM> cuts, and <NUM> filars.

<FIG> show additional examples of cut pattern segments for the catheter body <NUM>. For example, <FIG> shows a cut pattern segment having a plurality of circumferentially-spaced cuts <NUM> having a cut width between <NUM> and <NUM>, and may preferably be approximately <NUM>, and a plurality of circumferentially-spaced filars <NUM> having a width between <NUM> and <NUM>, and may preferably be approximately <NUM>. The plurality of cuts <NUM> and the plurality of filars <NUM> may each have a pitch angle α between <NUM> degrees and <NUM> degrees, and may preferably be approximately <NUM> degrees. The cut pattern segment may include between <NUM> and <NUM> cuts, and between <NUM> and <NUM> filars, and preferably include <NUM> cuts and <NUM> filars. The segment may have a length between <NUM> and <NUM>.

<FIG> shows a cut pattern segment having a plurality of circumferentially-spaced cuts <NUM> having a cut width between <NUM> and <NUM>, and may preferably be approximately <NUM>, and a plurality of circumferentially-spaced filars <NUM> having a width between <NUM> and <NUM>, and may preferably be approximately <NUM>. The plurality of cuts <NUM> and the plurality of filars <NUM> may each have a pitch angle α between <NUM> degrees and <NUM> degrees, and may preferably be approximately <NUM> degrees. The cut pattern segment may include between <NUM> and <NUM> cuts, and between <NUM> and <NUM> filars, and preferably include <NUM> cuts and <NUM> filars. The segment may have a length between <NUM> and <NUM>.

<FIG> and <FIG> show examples of flattened images of cut pattern segments disclosed herein, illustrating the significant variations in pitch angle and orientation of cut pattern segments that may be implemented along the length of the medical device <NUM> to provide the desired characteristics disclosed herein.

<FIG> show additional examples of cut pattern segments having significant variations in pitch angle and orientation of cut pattern segments that may be implemented along the length of the medical device <NUM>. For example, <FIG> illustrate examples where the pitch angle of the cuts and filars shifts dramatically between a first zone 22a and an adjacent second zone 22b to enable the catheter frame to be shape set into a curve from a straight position without compromising the cut pattern or lumen concentricity.

Now referring to <FIG>, the catheter body may include a distal tip segment <NUM> at or near the distal-most end of the catheter body <NUM>. The distal tip segment <NUM> may include one or more cut pattern segments having a plurality of cuts <NUM> and filars <NUM> as described herein. Individual pairs of filars <NUM> within a cut pattern segment of the distal tip segment <NUM> may be coupled, joined, or otherwise formed together to terminate at a filar tip <NUM>, thus eliminating a "single wire tip" sharp leading edge. The filar tip <NUM> may be rounded or otherwise have an atraumatic profile to avoid penetrating one or more linings or protective layers of the medical device <NUM>. The paired filars <NUM> thus form a plurality of helical segments extending around the longitudinal axis <NUM> of the catheter body <NUM>.

The pairs of filars/helical segments may terminate at different lengths along the longitudinal axis of the catheter body <NUM>, examples of which are shown in <FIG>. Alternatively, the pairs of filars/helical segments of a distal tip segment <NUM> may terminate at substantially coplanar or single longitudinal position along the catheter body <NUM>, as shown in <FIG>.

The direction of the pitch of the filars <NUM> within the distal tip segment <NUM> may vary, and the quantity of the filars <NUM> within the circumference of a particular distal tip segment <NUM> may also vary to provide the desired characteristics. For example, the distal tip segment shown in <FIG> includes <NUM> filars constituting <NUM> paired helical segments with staggered termination points along the length of the distal tip segment <NUM>. Such staggard termination will produce a graduation of axial stiffness and enable a reduction in the tip compliance from the catheter segmented body into the tip paired helical segments <NUM> and molded tip body <NUM>. <FIG> illustrates an example of a distal tip segment <NUM> having <NUM> filars constituting <NUM> paired helical segments that jointly terminate at a single position along the length of the distal tip segment <NUM>. <FIG> illustrates an example of a distal tip segment <NUM> having <NUM> filars constituting <NUM> paired helical segments that jointly terminate at a single position along the length of the distal tip segment <NUM>.

In one example, distal tip segment <NUM> may include at least one cut pattern segment having a plurality of circumferentially-spaced cuts <NUM> having a cut width between <NUM> and <NUM>, and a plurality of circumferentially-spaced filars <NUM> having a width between <NUM> and <NUM>. The plurality of cuts <NUM> and the plurality of filars <NUM> may each have a pitch angle α between <NUM> degrees and <NUM> degrees. The distal tip segment <NUM> may include between <NUM> and <NUM> cuts, and between <NUM> and <NUM> filars. The distal tip segment <NUM> may have a segment length between <NUM> and <NUM>.

In another example, distal tip segment <NUM> may include at least one cut pattern segment having a plurality of circumferentially-spaced cuts <NUM> having a cut width between <NUM> and <NUM>, and a plurality of circumferentially-spaced filars <NUM> having a width between <NUM> and <NUM>. The plurality of cuts <NUM> and the plurality of filars <NUM> may each have a pitch angle α between <NUM> degrees and <NUM> degrees. The distal tip segment <NUM> may include between <NUM> and <NUM> cuts, and between <NUM> and <NUM> filars. The distal tip segment <NUM> may have a segment length between <NUM> and <NUM>.

Additional examples of the distal tip segment <NUM> are shown in <FIG>, having varying static or progressive cut widths, pitch angles, filar widths and/or axial struts therebetween.

Now referring to <FIG>, graphs of recorded test results for examples of the medical device <NUM> and components thereof described herein are shown. <FIG> shows data regarding a <NUM>-point bend test along the length of a catheter body having a definable progressive flexibility along the length of the catheter body in a proximal-to-distal direction. <FIG> similarly shows data regarding a <NUM>-point bend test along the length of a catheter body with a polymer liner and jacket, the catheter body assembly having a definable progressive flexibility along the length of the catheter body in a proximal-to-distal direction. <FIG> shows guidewire frictional force data when a guidewire is removed from within a catheter body constructed as disclosed herein under varying distal track contours simulating vascular anatomy, demonstrating ease of use in over-the-wire applications. The different simulated paths for the curvature of the catheter under which the frictional force was measured is shown in pictures of the test fixture labeled 'A', 'B', and 'C'.

<FIG> illustrates a graph of axial pull force testing on an example of a catheter body constructed as disclosed herein (e.g., "Multi-Filar") versus a single filar construction. As shown by the graph, the multi-filar construction provides increased axial pull strength compared to the single filar construct, and the multi-filar construction provides such improved axial pull strength while also maintaining a high degree of flexibility as shown in the other tables and graphs disclosed herein.

<FIG> illustrates a graph of torque transmission testing on an example of a catheter body constructed as disclosed herein (e.g., "Multi-Filar") versus a single filar construction. As shown by the graph, the multi-filar construction provides equivalent torque response in both clockwise and counter clockwise transmission compared to a single filar construct, and the multi-filar construction provides equivalent torque transmission while also maintaining a high degree of flexibility as shown in the other tables and graphs disclosed herein.

The examples and associated dimensions of the medical devices <NUM> described above may be modified for different applications to conform to and/or adapt for use in different anatomical structures and/or for different patients. One or more portions of the device <NUM> may be radiopaque and/or include radiopaque markers to aid in medical imaging of the device during a procedure. Radiopaque features may be achieved, for example, through the use of marker bands, plating, the inclusion or infusion of tantalum, platinum, gold, tungsten, bismuth, and/or barium sulphate into or onto one or more components of the device. The device <NUM> may also include one or more polymer liners and outer jackets as well as coating(s) <NUM> on surfaces thereof along the length of the device. A filled polymer with one or more of these radiopaque materials may be melted into the distal tip pattern to enable a continuous transition of flexibility compliance from the catheter shaft to the distal polymer tip end.

Claim 1:
A catheter (<NUM>), comprising:
a catheter tube (<NUM>) defining:
a proximal end (<NUM>);
a distal end (<NUM>);
a longitudinal axis (<NUM>);
a lumen (<NUM>) therethrough; and
a first zone (<NUM>) having a first cut pattern segment (<NUM>) therein,
wherein the first cut pattern segment (<NUM>) defines a plurality of spiral cuts (<NUM>) spaced around a circumference of the tube (<NUM>),
wherein each of the plurality of spiral cuts (<NUM>) defines a width (<NUM>) between <NUM> and <NUM>,
wherein each of the plurality of spiral cuts (<NUM>) is spaced from an adjacent cut (<NUM>) by a filar (<NUM>) having a width (<NUM>) between <NUM> and <NUM>, and
wherein each of the plurality of spiral cuts (<NUM>) defines a pitch angle (α) with the longitudinal axis (<NUM>) between <NUM> degrees and <NUM> degrees.