Multifilament Catheter Body Structure
By dividing multiple cutting pattern segments with spiral cutting and filling structures on the catheter body, the problem that existing catheter designs are difficult to achieve multiple performances simultaneously is solved, and the flexible operation and stability of the catheter in complex vascular paths is achieved.
Patent Information
- Application Number
- JP2024557154
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-03-30
- Filing Date
- 2023-03-29
- Publication Date
- 2025-04-15
AI Technical Summary
Existing small diameter catheter designs are difficult to achieve simultaneously - indentability, fine torque response, axis strength stability, luminal concentration, anti-plastic deformation and fatigue resistance, especially when operating in complex vascular paths.
Using a catheter tube body with specific cutting patterns and filling structures, multiple cutting pattern segments are divided on the catheter tube body, each segment containing a helical cutting and filling structure, to adjust the flexibility and rigidity of the catheter, thereby achieving the optimization of various properties.
The flexible operation and stability of the catheter in complex vascular paths is achieved, improving the overall performance of the catheter, including indentability, torque response and fatigue resistance.
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Figure 2025510903000001_ABST
Abstract
Description
[Technical field]
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is related to and claims priority to U.S. Provisional Patent Application No. 63 / 325,320, entitled "Multifilamentary Catheter Body Structure," filed March 30, 2022, which is incorporated by reference in its entirety herein.
[0002] STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT N / A FIELD OF THE DISCLOSURE The present disclosure relates to intravascular medical devices and methods of use thereof. [Background technology]
[0003] Intravascular catheters are used in a variety of different therapeutic and diagnostic procedures to advance and position therapeutic devices at target locations within the body. Reaching such target locations may involve navigating tortuous vascular pathways with extreme turning or bending radii and / or dimensions that make access difficult for typical catheters. Although there are numerous vascular catheters and microcatheters designed to allow access to different anatomical locations within the vasculature, a key challenge facing small diameter catheter designs is to provide a combination of desirable pushability, fine torqueability response, axial strength stability, maintenance of lumen concentricity, resistance to catheter body plastic deformation or catheter body fatigue, and desirable variable flexibility over the length of the catheter. Providing and controlling such properties is critical to allow physicians to navigate and access a variety of complex and often tortuous anatomical vasculatures in the cardiovascular, peripheral, or neurovascular systems to deliver other auxiliary devices, contrast agents, aspirates, and other therapeutic agents.
[0004] There remains a need for improved designs of such catheters, and more generally, alternative designs for catheter tubing and substructures that allow not only ease of manufacture, but also design control of various properties of the catheter components, including steerability at any point along the catheter, torqueability, variable bending flexibility along the working length, pushability, resistance to luminal collapse or kinking, axial tensile strength, tip-to-catheter body transition compliance, etc. Summary of the Invention
[0005] The present disclosure provides a catheter including a catheter tube defining a proximal end, a distal end, a longitudinal axis, a lumen therethrough, and a first section having a first cut pattern segment therein, the first cut pattern segment defining a plurality of spiral cuts spaced around a circumference of the tube, each of the plurality of spiral cuts defining a width between 0.015 mm and 0.040 mm, each of the plurality of spiral cuts being spaced from an adjacent cut by a filler having a width between 0.015 mm and 0.125 mm, and each of the plurality of spiral cuts defining a pitch angle with the longitudinal axis between 30 degrees and 70 degrees.
[0006] The first section may have a stiffness of about 0 gF / mm to about 0.75 gF / mm. The plurality of spiral cuts may include 10 to 40 cuts. The first section may have a length of 1 mm to 100 mm. The catheter tube may be constructed from Nitinol and may have a wall thickness of about 0.0254 mm to about 0.254 mm. The catheter tube may be constructed from Inconel and may have a wall thickness of about 0.0254 mm to about 0.254 mm. The catheter tube may be constructed from stainless steel and may have a wall thickness of about 0.0254 mm to about 0.254 mm.
[0007] The distal end can include a tip segment having a plurality of helical segments extending about a longitudinal axis. Each helical segment can include two substantially parallel fillers connected at its distal end. The plurality of helical segments can include at least two helical segments.
[0008] The catheter may include a polymer liner disposed within the lumen and / or a polymer jacket disposed around the outer diameter of the cutting tube.
[0009] The catheter tube can include a second section having a second cut pattern segment therein, the second cut pattern segment defining a plurality of cuts spaced around a circumference of the tube, each of the plurality of cuts defining a width between 0.015 mm and 0.04 mm, each of the plurality of cuts being spaced from an adjacent cut by a filler having a width between 0.015 mm and 0.125 mm, and each of the plurality of cuts defining a pitch angle with the longitudinal axis between 45 degrees and 55 degrees.
[0010] The second region may be located proximal to the first region and / or may have a stiffness of about 0.75 gF / mm to about 1.25 gF / mm. The plurality of cuts in the second cut pattern segment may include 1 to 40 cuts. The second region may have a length of 1 mm to 100 mm.
[0011] The present disclosure also provides a catheter, the catheter including a catheter tube defining a proximal end, a distal end, a longitudinal axis, a lumen therethrough, and a first region having a first cut pattern segment therein, the first cut pattern segment defining a plurality of cuts spaced apart about a circumference of the tube, the plurality of cuts of the first cut pattern segment including 16-24 cuts, each of the plurality of cuts of the first cut pattern defining a pitch angle with the longitudinal axis between 60 degrees and 70 degrees.
[0012] The catheter tube can include a second section having a second cut pattern segment therein, the second cut pattern segment defining a plurality of cuts spaced around a circumference of the tube, the plurality of cuts of the second cut pattern segment including 16-24 cuts, and each of the plurality of cuts of the second cut pattern defining a pitch angle with the longitudinal axis of 45 degrees to 55 degrees.
[0013] The present disclosure also provides a catheter including a catheter tube defining a proximal end, a distal end, a longitudinal axis, a lumen therethrough, and a first region having a first cut pattern segment therein, the first cut pattern segment defining a plurality of cuts spaced around the circumference of the tube, the distal end including a tip segment having a plurality of helical segments extending around the longitudinal axis, each helical segment including two substantially parallel fillers connected at its distal end.
[0014] The present disclosure also provides a catheter, the catheter including a catheter tube defining a proximal end, a distal end, a longitudinal axis, a lumen therethrough, and a first section having a first cut pattern segment therein, the first cut pattern segment defining a plurality of spiral cuts spaced around a circumference of the tube, each of the plurality of spiral cuts defining a width between 0.018 mm and 0.026 mm, each of the plurality of spiral cuts being spaced from an adjacent cut by a filler having a width between 0.025 mm and 0.037 mm, and each of the plurality of spiral cuts defining a pitch angle with the longitudinal axis between 58 degrees and 68 degrees.
[0015] The cut pattern segments of the first region may have a length between 1.0 mm and 1.3 mm. The first region may include a plurality of first cut pattern segments therein, each of which may be separated from an adjacent first cut pattern segment by a non-cut segment having a length between 0.06 mm and 0.1 mm. The plurality of spiral cuts may include 12 to 22 cuts. The first region may have a stiffness between about 0.1 gF / mm and about 0.16 gF / mm. The catheter tube may have an outer diameter between 0.6 mm and 0.7 mm, the lumen may have a diameter between 0.45 mm and 0.52 mm, and / or the catheter tube may have a wall thickness between 0.07 mm and 0.1 mm.
[0016] The catheter tube can include a second section having a second cut pattern segment therein, the second cut pattern segment defining a plurality of cuts spaced around a circumference of the tube, each of the plurality of cuts defining a width between 0.018 mm and 0.026 mm, each of the plurality of cuts being separated from an adjacent cut by a filler having a width between 0.05 mm and 0.07 mm, and each of the plurality of cuts defining a pitch angle with the longitudinal axis between 44 degrees and 54 degrees.
[0017] The catheter tube can include a third section having a third cut pattern segment therein, the third cut pattern segment defining a plurality of cuts spaced around a circumference of the tube, each of the plurality of cuts defining a width between 0.018 mm and 0.026 mm, each of the plurality of cuts being spaced from an adjacent cut by a filler having a width between 0.05 mm and 0.12 mm, and each of the plurality of cuts defining a pitch angle with the longitudinal axis between 27 degrees and 37 degrees.
[0018] The present disclosure also provides a catheter, the catheter including a catheter tube defining a proximal end, a distal end, a longitudinal axis, a lumen therethrough, and a first section having a first cut pattern segment therein, the first cut pattern segment defining a plurality of spiral cuts spaced around a circumference of the tube, each of the plurality of spiral cuts defining a width between 0.018 mm and 0.026 mm, each of the plurality of spiral cuts being spaced from an adjacent cut by a filler having a width between 0.04 mm and 0.07 mm, and each of the plurality of spiral cuts defining a pitch angle with the longitudinal axis between 70 degrees and 80 degrees.
[0019] The cut pattern segments of the first region may have a length between 1.0 mm and 2.0 mm. The first region may include a plurality of first cut pattern segments therein, each of the first cut pattern segments being separated from an adjacent first cut pattern segment by a non-cut segment having a length between 0.05 mm and 0.15 mm. The plurality of spiral cuts may include 5 to 10 cuts. The first region may have a stiffness between about 0.1 gF / mm and about 0.16 gF / mm.
[0020] The catheter tube may have an outer diameter of 0.65 mm to 0.78 mm, the lumen may have a diameter of 0.4 mm to 0.55 mm, and / or the catheter tube may have a wall thickness of 0.05 mm to 0.11 mm.
[0021] The catheter tube can include a second section having a second cut pattern segment therein, the second cut pattern segment defining a plurality of cuts spaced around a circumference of the tube, each of the plurality of cuts defining a width between 0.018 mm and 0.026 mm, each of the plurality of cuts being separated from an adjacent cut by a filler having a width between 0.045 mm and 0.075 mm, and each of the plurality of cuts defining a pitch angle with the longitudinal axis between 44 degrees and 54 degrees.
[0022] The catheter tube can include a third section having a third cut pattern segment therein, the third cut pattern segment defining a plurality of cuts spaced around a circumference of the tube, each of the plurality of cuts defining a width between 0.018 mm and 0.026 mm, each of the plurality of cuts being spaced from an adjacent cut by a filler having a width between 0.07 mm and 0.10 mm, and each of the plurality of cuts defining a pitch angle with the longitudinal axis between 27 degrees and 37 degrees.
[0023] The present disclosure also provides a catheter, the catheter including a catheter tube defining a proximal end, a distal end, a longitudinal axis, a lumen therethrough, and a first section having a first cut pattern segment therein, the first cut pattern segment defining a plurality of spiral cuts spaced around a circumference of the tube, each of the plurality of spiral cuts defining a width between 0.015 mm and 0.024 mm, each of the plurality of spiral cuts being spaced from an adjacent cut by a filler having a width between 0.025 mm and 0.045 mm, and each of the plurality of spiral cuts defining a pitch angle with the longitudinal axis between 59 degrees and 69 degrees.
[0024] The cut pattern segments of the first region may have a length between 1.0 mm and 1.3 mm. The first region may include a plurality of first cut pattern segments therein, each of the first cut pattern segments being separated from an adjacent first cut pattern segment by a non-cut segment having a length between 0.07 mm and 0.09 mm. The plurality of spiral cuts may include 15 to 25 cuts. The first region may have a stiffness between about 0.1 gF / mm and about 0.24 gF / mm.
[0025] The catheter tube may have an outer diameter of 0.66 mm to 0.86 mm, the lumen may have a diameter of 0.43 mm to 0.63 mm, and / or the catheter tube may have a wall thickness of 0.06 mm to 0.17 mm.
[0026] The catheter tube can include a second section having a second cut pattern segment therein, the second cut pattern segment defining a plurality of cuts spaced around a circumference of the tube, each of the plurality of cuts defining a width between 0.015 mm and 0.024 mm, each of the plurality of cuts being spaced from an adjacent cut by a filler having a width between 0.05 mm and 0.07 mm, and each of the plurality of cuts defining a pitch angle with the longitudinal axis between 43 degrees and 53 degrees.
[0027] The catheter tube can include a third section having a third cut pattern segment therein, the third cut pattern segment defining a plurality of cuts spaced around a circumference of the tube, each of the plurality of cuts defining a width between 0.018 mm and 0.028 mm, each of the plurality of cuts being spaced from an adjacent cut by a filler having a width between 0.07 mm and 0.09 mm, and each of the plurality of cuts defining a pitch angle with the longitudinal axis between 28 degrees and 38 degrees.
[0028] The present disclosure also provides a catheter, the catheter including a catheter tube defining a proximal end, a distal end, a longitudinal axis, a lumen therethrough, and a first section having a first cut pattern segment therein, the first cut pattern segment defining a plurality of spiral cuts spaced around a circumference of the tube, each of the plurality of spiral cuts defining a width between 0.025 mm and 0.035 mm, each of the plurality of spiral cuts being spaced from an adjacent cut by a filler having a width between 0.022 mm and 0.032 mm, and each of the plurality of spiral cuts defining a pitch angle with the longitudinal axis between 59 degrees and 69 degrees.
[0029] The cut pattern segments of the first region may have a length between 1.15 mm and 1.35 mm. The first region may include a plurality of first cut pattern segments therein, each of the first cut pattern segments being spaced from an adjacent first cut pattern segment by a non-cut segment having a length between 0.05 mm and 0.15 mm. The plurality of spiral cuts may include 16 to 24 cuts. The first region may have a stiffness between about 0.01 gF / mm and about 0.08 gF / mm.
[0030] The catheter tube may have an outer diameter of 0.7 mm to 0.8 mm, the lumen may have a diameter of 0.45 mm to 0.65 mm, and / or the catheter tube may have a wall thickness of 0.08 mm to 0.13 mm.
[0031] The catheter tube can include a second section having a second cut pattern segment therein, the second cut pattern segment defining a plurality of cuts spaced around a circumference of the tube, each of the plurality of cuts defining a width between 0.027 mm and 0.037 mm, each of the plurality of cuts being separated from an adjacent cut by a filler having a width between 0.038 mm and 0.048 mm, and each of the plurality of cuts defining a pitch angle with the longitudinal axis between 45 degrees and 55 degrees.
[0032] The catheter tube can include a third section having a third cut pattern segment therein, the third cut pattern segment defining a plurality of cuts spaced around a circumference of the tube, each of the plurality of cuts defining a width between 0.02 mm and 0.04 mm, each of the plurality of cuts being spaced from an adjacent cut by a filler having a width between 0.055 mm and 0.075 mm, and each of the plurality of cuts defining a pitch angle with the longitudinal axis between 40 degrees and 50 degrees.
[0033] The present disclosure also provides a catheter, the catheter including a catheter tube defining a proximal end, a distal end, a longitudinal axis, a lumen therethrough, and a first section having a first cut pattern segment therein, the first cut pattern segment defining a plurality of spiral cuts spaced around a circumference of the tube, each of the plurality of spiral cuts defining a width between 0.01 mm and 0.03 mm, each of the plurality of spiral cuts being spaced from an adjacent cut by a filler having a width between 0.04 mm and 0.06 mm, and each of the plurality of spiral cuts defining a pitch angle with the longitudinal axis between 55 degrees and 65 degrees.
[0034] The cut pattern segments of the first region may have a length between 1.0 mm and 1.5 mm. The first region may include a plurality of first cut pattern segments therein, each of which may be separated from an adjacent first cut pattern segment by a non-cut segment having a length between 0.05 mm and 0.15 mm. The plurality of spiral cuts may include 16 to 24 cuts. The first region may have a stiffness between about 0.008 gF / mm and about 0.16 gF / mm. The catheter tube may have an outer diameter between 0.7 mm and 0.8 mm, the lumen may have a diameter between 0.45 mm and 0.65 mm, and / or the catheter tube may have a wall thickness between 0.08 mm and 0.13 mm.
[0035] The catheter tube can include a second section having a second cut pattern segment therein, the second cut pattern segment defining a plurality of cuts spaced around a circumference of the tube, each of the plurality of cuts defining a width between 0.01 mm and 0.03 mm, each of the plurality of cuts being spaced from an adjacent cut by a filler having a width between 0.05 mm and 0.07 mm, and each of the plurality of cuts defining a pitch angle with the longitudinal axis between 45 degrees and 55 degrees.
[0036] The catheter tube can include a third section having a third cut pattern segment therein, the third cut pattern segment defining a plurality of cuts spaced around a circumference of the tube, each of the plurality of cuts defining a width between 0.01 mm and 0.03 mm, each of the plurality of cuts being spaced from an adjacent cut by a filler having a width between 0.06 mm and 0.09 mm, and each of the plurality of cuts defining a pitch angle with the longitudinal axis between 40 degrees and 50 degrees.
[0037] The present disclosure also provides a catheter, the catheter including a catheter tube defining a proximal end, a distal end, a longitudinal axis, a lumen therethrough, and a first section having a first cut pattern segment therein, the first cut pattern segment defining a plurality of spiral cuts spaced around a circumference of the tube, each of the plurality of spiral cuts defining a width between 0.01 mm and 0.03 mm, each of the plurality of spiral cuts being spaced from an adjacent cut by a filler having a width between 0.04 mm and 0.08 mm, and each of the plurality of spiral cuts defining a pitch angle with the longitudinal axis between 55 degrees and 65 degrees.
[0038] The cut pattern segments of the first region may have a length between 1.5 mm and 2.5 mm. The first region may include a plurality of first cut pattern segments therein, each of the first cut pattern segments being separated from an adjacent first cut pattern segment by a non-cut segment having a length between 0.25 mm and 0.5 mm. The plurality of spiral cuts may include 20 to 40 cuts. The first region may have a stiffness between about 0.1 gF / mm and about 45 gF / mm.
[0039] The catheter tube may have an outer diameter of 1.5 mm to 1.8 mm, the lumen may have a diameter of 1.25 mm to 1.75 mm, and / or the catheter tube may have a wall thickness of 0.06 mm to 0.10 mm.
[0040] The catheter tube can include a second section having a second cut pattern segment therein, the second cut pattern segment defining a plurality of cuts spaced around a circumference of the tube, each of the plurality of cuts defining a width between 0.01 mm and 0.03 mm, each of the plurality of cuts being spaced from an adjacent cut by a filler having a width between 0.1 mm and 0.2 mm, and each of the plurality of cuts defining a pitch angle with the longitudinal axis between 45 degrees and 55 degrees.
[0041] The catheter tube can include a third section having a third cut pattern segment therein, the third cut pattern segment defining a plurality of cuts spaced around a circumference of the tube, each of the plurality of cuts defining a width between 0.01 mm and 0.03 mm, each of the plurality of cuts being spaced from an adjacent cut by a filler having a width between 0.1 mm and 0.3 mm, and each of the plurality of cuts defining a pitch angle with the longitudinal axis between 35 degrees and 45 degrees.
[0042] The present disclosure also provides a catheter, the catheter including a catheter tube defining a proximal end, a distal end, a longitudinal axis, a lumen therethrough, and a first section having a first cut pattern segment therein, the first cut pattern segment defining a plurality of spiral cuts spaced around a circumference of the tube, the distal end including a tip segment having a plurality of spiral segments extending around the longitudinal axis, each spiral segment including two substantially parallel fillers connected at its distal end, the two substantially parallel fillers of each spiral segment having a width of 0.02 mm to 0.05 mm, the two substantially parallel fillers of each spiral segment being spaced apart from one another by a cut width of 0.025 mm to 0.1 mm, and each of the spiral segments defining a pitch angle with the longitudinal axis of 50 degrees to 65 degrees.
[0043] The tip segment may include 16 to 24 fillers. The tip segment may have a length of 2 mm to 6 mm.
[0044] The present disclosure also provides a catheter, the catheter including a catheter tube defining a proximal end, a distal end, a longitudinal axis, a lumen therethrough, and a first section having a first cut pattern segment therein, the first cut pattern segment defining a plurality of spiral cuts spaced around a circumference of the tube, the distal end including a tip segment having a plurality of spiral segments extending around the longitudinal axis, each spiral segment including two substantially parallel fillers connected at its distal end, the two substantially parallel fillers of each spiral segment having a width between 0.02 mm and 0.1 mm, the two substantially parallel fillers of each spiral segment being spaced apart from one another by a cut width between 0.07 mm and 0.12 mm, and each of the spiral segments defining a pitch angle with the longitudinal axis between 55 degrees and 65 degrees.
[0045] The tip segment may include 16 to 24 fillers. The tip segment may have a length of 1 mm to 4 mm.
[0046] The present disclosure also provides a catheter, the catheter including a catheter tube defining a proximal end, a distal end, a longitudinal axis, a lumen therethrough, and a first section having a first cut pattern segment therein, the first cut pattern segment defining a plurality of spiral cuts spaced around a circumference of the tube, the distal end including a tip segment having a plurality of spiral segments extending around the longitudinal axis, each spiral segment including two substantially parallel fillers connected at its distal end, the two substantially parallel fillers of each spiral segment having a width of 0.02 mm to 0.05 mm, the two substantially parallel fillers of each spiral segment being spaced apart from one another by a cut width of 0.05 mm to 0.10 mm, and each of the spiral segments defining a pitch angle with the longitudinal axis of 55 degrees to 65 degrees.
[0047] The tip segment may include 16 to 24 fillers. The tip segment may have a length of 1 mm to 4 mm.
[0048] A more complete understanding of the present disclosure, and the attendant advantages and features, will be more readily understood by reference to the following detailed description, when considered in conjunction with the accompanying drawings. [Brief description of the drawings]
[0049] [Figure 1] 1 is an example of a medical device constructed in accordance with the principles of the present disclosure. [Diagram 2] 1 is an example of a distal portion of a catheter body constructed in accordance with the principles of the present disclosure. [Diagram 3] 2 is a more detailed view of a portion of a catheter body tube constructed in accordance with the principles of the present disclosure. [Figure 4] 1 is another detailed view of a portion of a catheter body constructed in accordance with the principles of the present disclosure. [Diagram 5] 1 is an example of a portion of a catheter body having alternating pitch directions constructed in accordance with the principles of the present disclosure. [Figure 6A] 1 is an example of an incision tube portion of a catheter body constructed in accordance with the principles of the present disclosure; [Figure 6B] 1 is an example of an incision tube portion of a catheter body constructed in accordance with the principles of the present disclosure; [Figure 6C] 1 is an example of an incision tube portion of a catheter body constructed in accordance with the principles of the present disclosure; [Figure 6D] 1 is an example of a cutting tube portion of a catheter body constructed in accordance with the principles of the present disclosure. [Figure 6E] 1 is an example of a flat cut tube cut pattern portion of a catheter body constructed in accordance with the principles of the present disclosure; [Figure 6F] 1 is an example of a flat cut tube cut pattern portion of a catheter body constructed in accordance with the principles of the present disclosure. [Figure 6G] 1 is an example of an incision tube portion of a catheter body constructed in accordance with the principles of the present disclosure. [Figure 6H]1 is an example of an incision tube portion of a catheter body constructed in accordance with the principles of the present disclosure. [Figure 6I] 1 is an example of an incision tube portion of a catheter body constructed in accordance with the principles of the present disclosure. [Figure 6J] 1 is an example of an incision tube portion of a catheter body constructed in accordance with the principles of the present disclosure. [Figure 7] 1 is an example of a distal cut tube segment within a catheter distal tip section with cross-sectional rendering of a tip structure of a medical device constructed in accordance with the principles of the present disclosure. [Figure 8] FIG. 8 is a perspective view of the distal tip segment of FIG. [Figure 9] 13 is another example of an incision tube component of a distal tip segment of a medical device constructed in accordance with the principles of the present disclosure. [Figure 10] 11 is a perspective view of another example of an incision tube component of a distal tip segment of a medical device constructed in accordance with the principles of the present disclosure. [Figure 11] 11 is a perspective view of another example of an incision tube portion of another example distal tip segment of a medical device constructed in accordance with the principles of the present disclosure. [Figure 12] 11 is a perspective view of another example cutting tube section of another example distal tip segment of a medical device constructed in accordance with the principles of the present disclosure. FIG. [Figure 13A] 1A-1C are additional examples of incision tube sections of various distal tip segment configurations of a medical device constructed in accordance with the principles of the present disclosure; [Figure 13B] 1A-1C are additional examples of incision tube sections of various distal tip segment configurations of a medical device constructed in accordance with the principles of the present disclosure; [Figure 13C] 1A-1C are additional examples of incision tube sections of various distal tip segment configurations of a medical device constructed in accordance with the principles of the present disclosure; [Figure 13D] 1A-1C are additional examples of incision tube sections of various distal tip segment configurations of a medical device constructed in accordance with the principles of the present disclosure; [Figure 13E]1A-1C are additional examples of incision tube sections of various distal tip segment configurations of a medical device constructed in accordance with the principles of the present disclosure; [Figure 13F] 1A-1C are additional examples of incision tube sections of various distal tip segment configurations of a medical device constructed in accordance with the principles of the present disclosure; [Figure 13G] 11A-11C are additional examples of cutting tube sections of various distal tip segment configurations of a medical device constructed in accordance with the principles of the present disclosure. [Figure 14] 1 is a graph illustrating three-point bend test performance of example catheter bodies constructed in accordance with the principles of the present disclosure. [Figure 15] 1 is a graph illustrating three-point bend test performance of example catheter bodies having polymer layers constructed in accordance with the principles of the present disclosure. [Figure 16] 1 is a graph illustrating friction force testing performance of example catheter bodies constructed in accordance with the principles of the present disclosure. [Figure 17] 1 is a graph illustrating the axial pull test performance of an example catheter body constructed in accordance with the principles of the present disclosure. [Figure 18] 11 is a graph illustrating torque shaft transmission test performance of an example catheter body constructed in accordance with the principles of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0050] The present disclosure provides improved designs of catheter structures, and more generally, alternative designs of catheter tubing and substructures that allow for ease of manufacture as well as control and improvement of various properties of predestinable components along the length of the catheter, providing a desirable combination of pushability including steerability, fine torque characteristic response, axial tensile strength, luminal stability and maintenance of concentricity, using variable bending stiffness and flexibility along the working length of the catheter, resistance to circumferential collapse or kinking bending, resistance to catheter body plastic deformation or catheter body fatigue at any point along the catheter, etc.
[0051] Referring now to the drawings, FIGS. 1-6 show example embodiments of devices and components of an endovascular medical device 10, such as a catheter, configured according to the principles and advantages disclosed herein. The device 10 is a minimally invasive device that can be introduced and manipulated percutaneously and intravascularly in combination with one or more other devices as disclosed herein, such as those used in interventional radiology, cardiology, and neuroradiology, to evaluate and / or treat blockages, occlusions, or other vascular defects, malformations, and / or conditions. Examples of medical devices 10 include, but are not limited to, catheters, microcatheters, balloon catheters, guide catheters, guide catheter extensions, dual lumen catheters, dissection and / or subintimal reentry catheters, aspiration catheters, device delivery catheters for vascular and structural heart valves, stent grafts, stents, or vascular filters, and the like. The medical device may be configured to enter and pass through neurovascular, coronary, peripheral, and / or arterial pathways and may be configured for non-vascular endoscopic and / or laparoscopic applications.
[0052] The device 10 generally includes an elongated catheter body 12 having sufficient length, flexibility, and torque characteristics to be introduced and manipulated from outside the patient and to traverse the vasculature and be positioned proximate to the area to be evaluated or treated. The catheter body 12 generally includes a proximal segment 14, which may be connected to and / or terminated at a hub or other component external to the patient, and a distal segment 16, which may be manufactured from a continuous length of a definable segment. The catheter body 12 further includes or defines a lumen 18 extending therethrough and exiting the distal segment 16, the lumen 18 having a diameter sufficient to pass a guidewire or other interventional device, such as a coil or embolic material, and / or to introduce one or more other medical instruments or devices through the catheter body 12. The catheter body 12 generally may define a longitudinal axis 20 along its length.
[0053] The catheter body 12 may be constructed, at least in part, from polymer or metal tubing, hypotubes, or other tubular or cylindrical constructions having one or more segments constructed from metals, nitinol, stainless steel, polymers, polymer compositions, and / or other materials and composites thereof. The catheter body 12 may comprise an integral, single-piece structure, or may be modular and include multiple components of materials of similar or varying composition assembled, attached, or otherwise joined together to form the body 12. Additional features of the device 10 and catheter body 12 are provided in U.S. Patent Application No. 15 / 726,024 (U.S. Patent Publication No. 2018 / 0093070), entitled "Modular Vascular Catheter," and U.S. Patent Application No. 16 / 255,141 (U.S. Patent Publication No. 2019 / 0160259), entitled "Variably Flexible Catheter Support Frame," both of which are incorporated herein by reference in their entireties.
[0054] The catheter body 12 can include one or more sections 22a, 22b, 22c...22z (collectively referred to as "22") along its length that provide various properties related to steerability, torqueability, variable bending flexibility, pushability, collapse or kink resistance, resistance to catheter shaft fatigue or plastic deformation capability, etc. Each section 22 can have, for example, a different multifilament cut pattern, length, spacing between cut pattern segments, wall structure, material composition, or other design features that differ from the other sections 22 to provide the desired functionality of the device 10.
[0055] Each region 22 may include one or more cut pattern segments 24a, 24b, 24c...24z (collectively referred to as "24") extending along its length. The cut pattern segments 24 in a particular region 22 may be substantially similar to other cut patterns or cut pattern segments 24 in that region, or may vary to provide a range of functional, progressive properties in the distal or proximal directions within a single region 22.
[0056] Each cut pattern segment 24 may include a cut pattern having a plurality of cuts or material that would otherwise be removed or absent from the catheter body to provide a desired function of the device 10. For example, a cut pattern segment 24 may include or define a plurality of circumferentially spaced apart cuts 26a, 26b, 26c...26z (collectively referred to as "26"). The cuts 26 within a cut pattern segment 24 may be substantially similar to one another or may vary within a single cut pattern segment 24. Each cut 26 may define a pitch angle α relative to a pitch axis 27 and the longitudinal axis 20 of the catheter body 12, and may define a cut width 28 when measured perpendicular to the pitch angle axis. The direction of the pitch of the cuts 26 may vary between cut pattern segments 24 (i.e., counterclockwise vs. clockwise rotation of pitch, as shown in FIG. 5), and the amount of cuts 26 within the circumference of a particular cut pattern segment 24 may also vary to provide desired characteristics within the region 22 and helical length of the cut relative to the longitudinal axis or segment length.
[0057] Each cut pattern segment 24 may include multiple non-cut portions or fillers 30a, 30b, 30c...30z (collectively referred to as "30") between the cuts 26 to provide the desired functionality of the device 10. The fillers 30 within a cut pattern segment 24 may be substantially similar to one another or may vary within a single cut pattern segment 24. Each filler 30 may have the same pitch angle α as the cut 26 relative to the longitudinal axis 20 of the catheter body 12 and may define a filler width 32 as measured perpendicular to the pitch angle axis. The orientation of the pitch of the fillers 30 may vary between cut pattern segments 24 (i.e., counterclockwise vs. clockwise rotation of the pitch), and the amount of fillers 30 within the circumference of a particular cut pattern segment 24 may also vary to provide the desired properties within the region 22. The disclosed multi-filament feature provides improved axial tensile strength compared to prior art monofilament or filament designs, among other advantages and improved functionality disclosed herein.
[0058] The catheter body 12 can include or define a non-cut segment 34 disposed longitudinally between consecutive or adjacent cuts 26. The non-cut segment 34 can define a length 36 measured along the longitudinal axis 20 to form a non-cut region or loop between consecutive or adjacent cuts 26. The non-cut segment(s) 34 can comprise a break from one cut pattern to the next. For example, these break cut segments can repeat along the length of the body 12 at substantially the same circumferential location about the central axis to resume the in-line cut pattern to the next adjacent cut segment.
[0059] Each cut pattern segment 24 can define a length 38 as measured along the longitudinal axis 20, the length 38 including the length of the multiple cuts 26 therein and half the non-cut segment length 36 on each edge on either side of the cut 26.
[0060] In one example, the catheter body 12 may include a first section 22a at or near a distal portion of the medical device 10. The first section 22a may include at least one cut pattern segment 24a having a plurality of circumferentially spaced apart cuts 26 having a cut width that may be between 0.015 mm and 0.03 mm, preferably about 0.023 mm. The first section 22a may define a plurality of circumferentially spaced apart fillers 30 having a width that may be between 0.025 mm and 0.035 mm, preferably about 0.030 mm.
[0061] Each of the plurality of cuts 26 and the plurality of fillers 30 may have a pitch angle α that may be between 60 degrees and 70 degrees, preferably about 65 degrees. Cut pattern segment 24a may include 16-24 cuts and 16-24 fillers. Cut pattern segment 24a may preferably include 20 cuts and 20 fillers.
[0062] The first region 22a may include a plurality of cut pattern segments having the dimensions specified above. The number of cut pattern segments in the first region 22a may be between 1 and 40. Each cut pattern segment in the first region 22a has a segment length that may be between 1 mm and 1.3 mm, preferably about 1.15 mm. The first region 22a may include a plurality of non-cut segments 34, each non-cut segment 34 defining a non-cut segment length that may be between 0.05 mm and 0.1 mm, preferably about 0.075 mm.
[0063] This first section 22a may have an average flexibility of about 0 gF / mm to about 0.75 gF / mm.
[0064] Continuing with this example of an exemplary medical device, the catheter body 12 may include a second section 22b located proximal to the first section 22a. The second section 22b may include at least one cut pattern segment 24b having a plurality of circumferentially spaced apart cuts 26 having a cut width that may be between 0.015 mm and 0.03 mm, preferably about 0.022 mm. The second section 22b may define a plurality of circumferentially spaced apart fillers 30 having a width that may be between 0.055 mm and 0.065 mm, preferably about 0.06 mm.
[0065] Each of the plurality of cuts 26 and the plurality of fillers 30 may have a pitch angle α that may be between 45 degrees and 55 degrees, preferably about 50 degrees. Cut pattern segment 24b may include 16-24 cuts and 16-24 fillers. Cut pattern segment 24b may preferably include 20 cuts and 20 fillers.
[0066] The second region 22b may include a plurality of cut pattern segments having the dimensions specified above. The number of cut pattern segments in the second region 22b may be between 1 and 40. Each cut pattern segment in the second region 22b has a segment length that may be between 2 mm and 2.3 mm, preferably about 2.15 mm. The second region 22b may include a plurality of non-cut segments 34, each non-cut segment 34 defining a non-cut segment length that may be between 0.1 mm and 0.2 mm, preferably about 0.15 mm.
[0067] This second section 22b may have an average flexibility of about 0.75 gF / mm to about 1.25 gF / mm.
[0068] Continuing with this example, the catheter body 12 may include a third section 22c located proximal to the second section 22b. The third section 22c may include at least one cut pattern segment 24c having a plurality of circumferentially spaced apart cuts 26 having a cut width that may be between 0.02 mm and 0.03 mm, preferably about 0.023 mm. The third section 22c may define a plurality of circumferentially spaced apart fillers 30 having a width that may be between 0.08 mm and 0.09 mm, preferably about 0.085 mm.
[0069] Each of the plurality of cuts 26 and the plurality of fillers 30 may have a pitch angle α that may be between 25 degrees and 40 degrees, preferably about 32 degrees. Cut pattern segment 24c may include 16-24 cuts and 16-24 fillers. Cut pattern segment 24c may preferably include 20 cuts and 20 fillers.
[0070] The third region 22c may include a plurality of cut pattern segments having the dimensions specified above. The number of cut pattern segments in the third region 22c may be between 1 and 40. Each cut pattern segment in the third region 22c has a segment length that may be between 3 mm and 5 mm, preferably about 4 mm. The third region 22c may include a plurality of non-cut segments 34, each non-cut segment 34 defining a non-cut segment length that may be between 0.10 mm and 0.25 mm, preferably about 0.17 mm.
[0071] This third section 22c may have an average flexibility of about 1.25 gF / mm to about 1.75 gF / mm.
[0072] In one example, the catheter body 12 can have an inner diameter of 0.254 mm to 1.27 mm, an outer diameter of 0.0508 mm to 0.254 mm, and / or a wall thickness of 0.051 mm to 0.102 mm. Variations of the dimensions and patterns described herein can be incorporated into devices of all applicable inner and outer diameters, including those ranging from 3 French to 34 French.
[0073] In one example, the catheter body 12 may include a first section 22a at or near a distal portion of the medical device 10. The first section 22a may include at least one cut pattern segment 24a having a plurality of circumferentially spaced apart cuts 26 having a cut width that may be between 0.015 mm and 0.25 mm, preferably about 0.02 mm. The first section 22a may define a plurality of circumferentially spaced apart fillers 30 having a width that may be between 0.03 mm and 0.04 mm, preferably about 0.034 mm.
[0074] Each of the plurality of cuts 26 and the plurality of fillers 30 may have a pitch angle α that may be between 60 degrees and 70 degrees, preferably about 64 degrees. Cut pattern segment 24a may include 16-24 cuts and 16-24 fillers. Cut pattern segment 24a may preferably include 20 cuts and 20 fillers.
[0075] The first region 22a may include a plurality of cut pattern segments having the dimensions specified above. The number of cut pattern segments in the first region 22a may be between 1 and 40. Each cut pattern segment in the first region 22a has a segment length that may be between 1 mm and 1.3 mm, preferably about 1.15 mm. The first region 22a may include a plurality of non-cut segments 34, each non-cut segment 34 defining a non-cut segment length that may be between 0.05 mm and 0.1 mm, preferably about 0.08 mm.
[0076] This first section 22a may have an average flexibility of about 0 gF / mm to about 0.75 gF / mm.
[0077] Continuing with this example of an exemplary medical device, the catheter body 12 may include a second section 22b located proximal to the first section 22a. The second section 22b may include at least one cut pattern segment 24b having a plurality of circumferentially spaced apart cuts 26 having a cut width that may be between 0.015 mm and 0.025 mm, preferably about 0.02 mm. The second section 22b may define a plurality of circumferentially spaced apart fillers 30 having a width that may be between 0.055 mm and 0.065 mm, preferably about 0.06 mm.
[0078] Each of the plurality of cuts 26 and the plurality of fillers 30 may have a pitch angle α that may be between 45 degrees and 55 degrees, preferably about 48 degrees. Cut pattern segment 24b may include 16-24 cuts and 16-24 fillers. Cut pattern segment 24b may preferably include 20 cuts and 20 fillers.
[0079] The second region 22b may include a plurality of cut pattern segments having the dimensions specified above. The number of cut pattern segments in the second region 22b may be between 1 and 40. Each cut pattern segment in the second region 22b has a segment length that may be between 2 mm and 2.3 mm, preferably about 2.15 mm. The second region 22b may include a plurality of non-cut segments 34, each non-cut segment 34 defining a non-cut segment length that may be between 0.1 mm and 0.2 mm, preferably about 0.15 mm.
[0080] This second section 22b may have an average flexibility of about 0.75 gF / mm to about 1.25 gF / mm.
[0081] Continuing with this example, the catheter body 12 may include a third section 22c located proximal to the second section 22b. The third section 22c may include at least one cut pattern segment 24c having a plurality of circumferentially spaced apart cuts 26 having a cut width that may be between 0.02 mm and 0.03 mm, preferably about 0.023 mm. The third section 22c may define a plurality of circumferentially spaced apart fillers 30 having a width that may be between 0.07 mm and 0.09 mm, preferably about 0.08 mm.
[0082] Each of the plurality of cuts 26 and the plurality of fillers 30 may have a pitch angle α that may be between 25 degrees and 40 degrees, preferably about 32 degrees. Cut pattern segment 24c may include 16-24 cuts and 16-24 fillers. Cut pattern segment 24c may preferably include 20 cuts and 20 fillers.
[0083] The third region 22c may include a plurality of cut pattern segments having the dimensions specified above. The number of cut pattern segments in the third region 22c may be between 1 and 40. Each cut pattern segment in the third region 22c has a segment length that may be between 3 mm and 5 mm, preferably about 4 mm. The third region 22c may include a plurality of non-cut segments 34, each non-cut segment 34 defining a non-cut segment length that may be between 0.10 mm and 0.25 mm, preferably about 0.18 mm.
[0084] This third section 22c may have an average flexibility of about 1.25 gF / mm to about 1.75 gF / mm.
[0085] In one example, the catheter body 12 can have an inner diameter of 0.254 mm to 1.27 mm, an outer diameter of 0.0508 mm to 0.254 mm, and / or a wall thickness of 0.051 mm to 0.102 mm.
[0086] In another example, the catheter body 12 can have an inner diameter of 0.45 mm to 0.52 mm, an outer diameter of 0.6 mm to 0.7 mm, and / or a wall thickness of 0.07 mm to 0.1 mm. Variations of the dimensions and patterns described herein can be incorporated into devices of all applicable inner and outer diameters, including those ranging from 3 French to 34 French.
[0087] In this example, the catheter body 12 may include a first section 22a at or near a distal portion of the medical device 10. The first section 22a may include at least one cut pattern segment 24a having a plurality of circumferentially spaced apart cuts 26 having a cut width that may be between 0.018 mm and 0.026 mm, preferably about 0.022 mm. The first section 22a may define a plurality of circumferentially spaced apart fillers 30 having a width that may be between 0.025 mm and 0.037 mm, preferably about 0.031 mm.
[0088] Each of the plurality of cuts 26 and the plurality of fillers 30 may have a pitch angle α that may be between 58 degrees and 68 degrees, preferably about 63 degrees. The cut pattern segment 24a may include 12-22 cuts and 12-22 fillers. The cut pattern segment 24a may preferably include 17 cuts and 17 fillers.
[0089] The first region 22a may include a plurality of cut pattern segments having the dimensions specified above. The number of cut pattern segments in the first region 22a may be between 1 and 40. Each cut pattern segment in the first region 22a has a segment length that may be between 1.0 mm and 1.3 mm, preferably about 1.15 mm. The first region 22a may include a plurality of non-cut segments 34, each non-cut segment 34 defining a non-cut segment length that may be between 0.06 mm and 0.1 mm, preferably about 0.08 mm.
[0090] This first section 22a may have an average flexibility of about 0.1 gF / mm to about 0.16 gF / mm.
[0091] Continuing with this example of an exemplary medical device, the catheter body 12 may include a second section 22b located proximal to the first section 22a. The second section 22b may include at least one cut pattern segment 24b having a plurality of circumferentially spaced apart cuts 26 having a cut width that may be between 0.018 mm and 0.026 mm, preferably about 0.022 mm. The second section 22b may define a plurality of circumferentially spaced apart fillers 30 having a width that may be between 0.05 mm and 0.07 mm, preferably about 0.06 mm.
[0092] Each of the plurality of cuts 26 and the plurality of fillers 30 may have a pitch angle α that may be between 44 degrees and 54 degrees, preferably about 49 degrees. Cut pattern segment 24b may include 12-22 cuts and 12-22 fillers. Cut pattern segment 24b may preferably include 17 cuts and 17 fillers.
[0093] The second region 22b may include a plurality of cut pattern segments having the dimensions specified above. The number of cut pattern segments in the second region 22b may be between 20 and 80. Each cut pattern segment in the second region 22b has a segment length that may be between 2.0 mm and 2.3 mm, preferably about 2.14 mm. The second region 22b may include a plurality of non-cut segments 34, each non-cut segment 34 defining a non-cut segment length that may be between 0.08 mm and 0.18 mm, preferably about 0.13 mm.
[0094] This second region 22b may have an average flexibility of about 0.16 gF / mm to about 0.55 gF / mm.
[0095] Continuing with this example, the catheter body 12 may include a third section 22c located proximal to the second section 22b. The third section 22c may include at least one cut pattern segment 24c having a plurality of circumferentially spaced apart cuts 26 having a cut width that may be between 0.018 mm and 0.026 mm, preferably about 0.023 mm. The third section 22c may define a plurality of circumferentially spaced apart fillers 30 having a width that may be between 0.05 mm and 0.12 mm, preferably about 0.085 mm.
[0096] Each of the plurality of cuts 26 and the plurality of fillers 30 may have a pitch angle α that may be between 27 degrees and 37 degrees, preferably about 32 degrees. Cut pattern segment 24c may include 12-22 cuts and 12-22 fillers. Cut pattern segment 24c may preferably include 17 cuts and 17 fillers.
[0097] The third region 22c may include a plurality of cut pattern segments having the dimensions specified above. The number of cut pattern segments in the third region 22c may be between 50 and 150. Each cut pattern segment in the third region 22c has a segment length that may be between 3.5 mm and 4.5 mm, preferably about 3.95 mm. The third region 22c may include a plurality of non-cut segments 34, each non-cut segment 34 defining a non-cut segment length that may be between 0.12 mm and 0.22 mm, preferably about 0.17 mm.
[0098] This third region 22c may have an average flexibility of about 0.56 gF / mm to about 0.88 gF / mm.
[0099] In another example, the catheter body 12 can have an inner diameter of 0.4 mm to 0.55 mm, an outer diameter of 0.65 mm to 0.78 mm, and / or a wall thickness of 0.05 mm to 0.11 mm. Variations of the dimensions and patterns described herein can be incorporated into devices of all applicable inner and outer diameters, including those ranging from 3 French to 34 French.
[0100] In this example, the catheter body 12 may include a first section 22a at or near a distal portion of the medical device 10. The first section 22a may include at least one cut pattern segment 24a having a plurality of circumferentially spaced apart cuts 26 having a cut width that may be between 0.018 mm and 0.026 mm, preferably about 0.022 mm. The first section 22a may define a plurality of circumferentially spaced apart fillers 30 having a width that may be between 0.04 mm and 0.07 mm, preferably about 0.055 mm.
[0101] Each of the plurality of cuts 26 and the plurality of fillers 30 may have a pitch angle α that may be between 70 degrees and 80 degrees, preferably about 75 degrees. Cut pattern segment 24a may include 5-10 cuts and 5-10 fillers. Cut pattern segment 24a may preferably include 7 cuts and 7 fillers.
[0102] The first region 22a may include a plurality of cut pattern segments having the dimensions specified above. The number of cut pattern segments in the first region 22a may be between 1 and 40. Each cut pattern segment in the first region 22a has a segment length that may be between 1.0 mm and 2.0 mm, preferably about 1.5 mm. The first region 22a may include a plurality of non-cut segments 34, each non-cut segment 34 defining a non-cut segment length that may be between 0.05 mm and 0.15 mm, preferably about 0.11 mm.
[0103] This first section 22a may have an average flexibility of about 0.1 gF / mm to about 0.16 gF / mm.
[0104] Continuing with this example of an exemplary medical device, the catheter body 12 may include a second section 22b located proximal to the first section 22a. The second section 22b may include at least one cut pattern segment 24b having a plurality of circumferentially spaced apart cuts 26 having a cut width that may be between 0.018 mm and 0.026 mm, preferably about 0.022 mm. The second section 22b may define a plurality of circumferentially spaced apart fillers 30 having a width that may be between 0.045 mm and 0.075 mm, preferably about 0.06 mm.
[0105] Each of the plurality of cuts 26 and the plurality of fillers 30 may have a pitch angle α that may be between 44 degrees and 54 degrees, preferably about 49 degrees. Cut pattern segment 24b may include 12-22 cuts and 12-22 fillers. Cut pattern segment 24b may preferably include 17 cuts and 17 fillers.
[0106] The second region 22b may include a plurality of cut pattern segments having the dimensions specified above. The number of cut pattern segments in the second region 22b may be between 25 and 75. Each cut pattern segment in the second region 22b has a segment length that may be between 2.0 mm and 2.3 mm, preferably about 2.14 mm. The second region 22b may include a plurality of non-cut segments 34, each non-cut segment 34 defining a non-cut segment length that may be between 0.10 mm and 0.17 mm, preferably about 0.13 mm.
[0107] This second region 22b may have an average flexibility of about 0.16 gF / mm to about 0.56 gF / mm.
[0108] Continuing with this example, the catheter body 12 may include a third section 22c located proximal to the second section 22b. The third section 22c may include at least one cut pattern segment 24c having a plurality of circumferentially spaced apart cuts 26 having a cut width that may be between 0.018 mm and 0.026 mm, preferably about 0.023 mm. The third section 22c may define a plurality of circumferentially spaced apart fillers 30 having a width that may be between 0.07 mm and 0.10 mm, preferably about 0.085 mm.
[0109] Each of the plurality of cuts 26 and the plurality of fillers 30 may have a pitch angle α that may be between 27 degrees and 37 degrees, preferably about 32 degrees. Cut pattern segment 24c may include 12-22 cuts and 12-22 fillers. Cut pattern segment 24c may preferably include 17 cuts and 17 fillers.
[0110] The third region 22c may include a plurality of cut pattern segments having the dimensions specified above. The number of cut pattern segments in the third region 22c may be between 50 and 150. Each cut pattern segment in the third region 22c has a segment length that may be between 3.0 mm and 5.0 mm, preferably about 3.95 mm. The third region 22c may include a plurality of non-cut segments 34, each non-cut segment 34 defining a non-cut segment length that may be between 0.1 mm and 0.3 mm, preferably about 0.17 mm.
[0111] This third region 22c may have an average flexibility of about 0.55 gF / mm to about 0.88 gF / mm.
[0112] In another example, the catheter body 12 can have an inner diameter of 0.43 mm to 0.63 mm, an outer diameter of 0.66 mm to 0.86 mm, and / or a wall thickness of 0.06 mm to 0.17 mm. Variations of the dimensions and patterns described herein can be incorporated into devices of all applicable inner and outer diameters, including those ranging from 3 French to 34 French.
[0113] In this example, the catheter body 12 may include a first section 22a at or near a distal portion of the medical device 10. The first section 22a may include at least one cut pattern segment 24a having a plurality of circumferentially spaced apart cuts 26 having a cut width that may be between 0.015 mm and 0.024 mm, preferably about 0.019 mm. The first section 22a may define a plurality of circumferentially spaced apart fillers 30 having a width that may be between 0.025 mm and 0.045 mm, preferably about 0.34 mm.
[0114] Each of the plurality of cuts 26 and the plurality of fillers 30 may have a pitch angle α that may be between 59 degrees and 69 degrees, preferably about 64 degrees. Cut pattern segment 24a may include 15-25 cuts and 15-25 fillers. Cut pattern segment 24a may preferably include 20 cuts and 20 fillers.
[0115] The first region 22a may include a plurality of cut pattern segments having the dimensions specified above. The number of cut pattern segments in the first region 22a may be between 1 and 40. Each cut pattern segment in the first region 22a has a segment length that may be between 1.0 mm and 1.3 mm, preferably about 1.14 mm. The first region 22a may include a plurality of non-cut segments 34, each non-cut segment 34 defining a non-cut segment length that may be between 0.07 mm and 0.09 mm, preferably about 0.079 mm.
[0116] This first section 22a may have an average flexibility of about 0.1 gF / mm to about 0.24 gF / mm.
[0117] Continuing with this example of an exemplary medical device, the catheter body 12 may include a second section 22b located proximal to the first section 22a. The second section 22b may include at least one cut pattern segment 24b having a plurality of circumferentially spaced apart cuts 26 having a cut width that may be between 0.015 mm and 0.024 mm, preferably about 0.019 mm. The second section 22b may define a plurality of circumferentially spaced apart fillers 30 having a width that may be between 0.05 mm and 0.07 mm, preferably about 0.059 mm.
[0118] Each of the plurality of cuts 26 and the plurality of fillers 30 may have a pitch angle α that may be between 43 degrees and 53 degrees, preferably about 48 degrees. Cut pattern segment 24b may include 16-24 cuts and 16-24 fillers. Cut pattern segment 24b may preferably include 20 cuts and 20 fillers.
[0119] The second region 22b may include a plurality of cut pattern segments having the dimensions specified above. The number of cut pattern segments in the second region 22b may be between 25 and 75. Each cut pattern segment in the second region 22b has a segment length that may be between 2.0 mm and 2.3 mm, preferably about 2.14 mm. The second region 22b may include a plurality of non-cut segments 34, each non-cut segment 34 defining a non-cut segment length that may be between 0.10 mm and 0.20 mm, preferably about 0.14 mm.
[0120] This second section 22b may have an average flexibility of about 0.24 gF / mm to about 0.80 gF / mm.
[0121] Continuing with this example, the catheter body 12 may include a third section 22c located proximal to the second section 22b. The third section 22c may include at least one cut pattern segment 24c having a plurality of circumferentially spaced apart cuts 26 having a cut width that may be between 0.018 mm and 0.028 mm, preferably about 0.023 mm. The third section 22c may define a plurality of circumferentially spaced apart fillers 30 having a width that may be between 0.07 mm and 0.09 mm, preferably about 0.79 mm.
[0122] Each of the plurality of cuts 26 and the plurality of fillers 30 may have a pitch angle α that may be between 28 degrees and 38 degrees, preferably about 33 degrees. Cut pattern segment 24c may include 16-24 cuts and 16-24 fillers. Cut pattern segment 24c may preferably include 20 cuts and 20 fillers.
[0123] The third region 22c may include a plurality of cut pattern segments having the dimensions specified above. The number of cut pattern segments in the third region 22c may be between 75 and 150. Each cut pattern segment in the third region 22c has a segment length that may be between 3.5 mm and 4.5 mm, preferably about 4.12 mm. The third region 22c may include a plurality of non-cut segments 34, each non-cut segment 34 defining a non-cut segment length that may be between 0.1 mm and 0.3 mm, preferably about 0.18 mm.
[0124] This third section 22c may have an average flexibility of about 0.80 gF / mm to about 2.4 gF / mm.
[0125] In another example, the catheter body 12 can have an inner diameter of 0.45 mm to 0.65 mm, an outer diameter of 0.7 mm to 0.8 mm, and / or a wall thickness of 0.08 mm to 0.13 mm. Variations of the dimensions and patterns described herein can be incorporated into devices of all applicable inner and outer diameters, including those ranging from 3 French to 34 French.
[0126] In this example, the catheter body 12 may include a first section 22a at or near a distal portion of the medical device 10. The first section 22a may include at least one cut pattern segment 24a having a plurality of circumferentially spaced apart cuts 26 having a cut width that may be between 0.025 mm and 0.035 mm, preferably about 0.03 mm. The first section 22a may define a plurality of circumferentially spaced apart fillers 30 having a width that may be between 0.022 mm and 0.032 mm, preferably about 0.027 mm.
[0127] Each of the plurality of cuts 26 and the plurality of fillers 30 may have a pitch angle α that may be between 59 degrees and 69 degrees, preferably about 64 degrees. Cut pattern segment 24a may include 16-24 cuts and 16-24 fillers. Cut pattern segment 24a may preferably include 20 cuts and 20 fillers.
[0128] The first region 22a may include a plurality of cut pattern segments having the dimensions specified above. The number of cut pattern segments in the first region 22a may be between 1 and 40. Each cut pattern segment in the first region 22a has a segment length that may be between 1.15 mm and 1.35 mm, preferably about 1.25 mm. The first region 22a may include a plurality of non-cut segments 34, each non-cut segment 34 defining a non-cut segment length that may be between 0.05 mm and 0.15 mm, preferably about 0.1 mm.
[0129] This first section 22a may have an average flexibility of about 0.01 gF / mm to about 0.08 gF / mm.
[0130] Continuing with this example of an exemplary medical device, the catheter body 12 may include a second section 22b located proximal to the first section 22a. The second section 22b may include at least one cut pattern segment 24b having a plurality of circumferentially spaced apart cuts 26 having a cut width that may be between 0.027 mm and 0.037 mm, preferably about 0.032 mm. The second section 22b may define a plurality of circumferentially spaced apart fillers 30 having a width that may be between 0.038 mm and 0.048 mm, preferably about 0.043 mm.
[0131] Each of the plurality of cuts 26 and the plurality of fillers 30 may have a pitch angle α that may be between 45 degrees and 55 degrees, preferably about 50 degrees. Cut pattern segment 24b may include 16-24 cuts and 16-24 fillers. Cut pattern segment 24b may preferably include 20 cuts and 20 fillers.
[0132] The second region 22b may include a plurality of cut pattern segments having the dimensions specified above. The number of cut pattern segments in the second region 22b may be between 1 and 40. Each cut pattern segment in the second region 22b has a segment length that may be between 1.25 mm and 1.75 mm, preferably about 1.52 mm. The second region 22b may include a plurality of non-cut segments 34, each non-cut segment 34 defining a non-cut segment length that may be between 0.05 mm and 0.15 mm, preferably about 0.1 mm.
[0133] This second section 22b may have an average flexibility of about 0.08 gF / mm to about 0.24 gF / mm.
[0134] Continuing with this example, the catheter body 12 may include a third section 22c located proximal to the second section 22b. The third section 22c may include at least one cut pattern segment 24c having a plurality of circumferentially spaced apart cuts 26 having a cut width that may be between 0.02 mm and 0.04 mm, preferably about 0.031 mm. The third section 22c may define a plurality of circumferentially spaced apart fillers 30 having a width that may be between 0.055 mm and 0.075 mm, preferably about 0.064 mm.
[0135] Each of the plurality of cuts 26 and the plurality of fillers 30 may have a pitch angle α that may be between 40 degrees and 50 degrees, preferably about 45 degrees. Cut pattern segment 24c may include 14 to 22 cuts and 14 to 22 fillers. Cut pattern segment 24c may preferably include 18 cuts and 18 fillers.
[0136] The third region 22c may include a plurality of cut pattern segments having the dimensions specified above. The number of cut pattern segments in the third region 22c may be between 1 and 40. Each cut pattern segment in the third region 22c has a segment length that may be between 1.4 mm and 1.6 mm, preferably about 1.52 mm. The third region 22c may include a plurality of non-cut segments 34, each non-cut segment 34 defining a non-cut segment length that may be between 0.05 mm and 0.15 mm, preferably about 0.1 mm.
[0137] This third section 22c may have an average flexibility of about 0.24 gF / mm to about 1.04 gF / mm.
[0138] Continuing with this example of an exemplary medical device, the catheter body 12 may include a fourth section 22d located proximal to the first section 22a. The fourth section 22d may include at least one cut pattern segment 24d having a plurality of circumferentially spaced apart cuts 26 having a cut width that may be between 0.02 mm and 0.04 mm, preferably about 0.28 mm. The fourth section 22b may define a plurality of circumferentially spaced apart fillers 30 having a width that may be between 0.06 mm and 0.08 mm, preferably about 0.072 mm.
[0139] Each of the plurality of cuts 26 and the plurality of fillers 30 may have a pitch angle α that may be between 35 degrees and 45 degrees, preferably about 40 degrees. Cut pattern segment 24d may include 16-24 cuts and 16-24 fillers. Cut pattern segment 24d may preferably include 18 cuts and 18 fillers.
[0140] The fourth region 22d may include a plurality of cut pattern segments having the dimensions specified above. The number of cut pattern segments in the fourth region 22d may be between 1 and 40. Each cut pattern segment in the fourth region 22d has a segment length that may be between 1.25 mm and 1.75 mm, preferably about 1.52 mm. The fourth region 22d may include a plurality of non-cut segments 34, each non-cut segment 34 defining a non-cut segment length that may be between 0.05 mm and 0.15 mm, preferably about 0.1 mm.
[0141] This fourth region 22b may have an average flexibility of about 1.04 gF / mm to about 1.68 gF / mm.
[0142] Continuing with this example, the catheter body 12 may include a fifth section 22e located proximal to the fourth section 22e. The fifth section 22e may include at least one cut pattern segment 24e having a plurality of circumferentially spaced apart cuts 26 having a cut width that may be between 0.02 mm and 0.04 mm, preferably about 0.03 mm. The fifth section 22e may define a plurality of circumferentially spaced apart fillers 30 having a width that may be between 0.07 mm and 0.09 mm, preferably about 0.08 mm.
[0143] Each of the plurality of cuts 26 and the plurality of fillers 30 may have a pitch angle α that may be between 25 degrees and 35 degrees, preferably about 30 degrees. Cut pattern segment 24e may include 16-24 cuts and 16-24 fillers. Cut pattern segment 24e may preferably include 18 cuts and 18 fillers.
[0144] The fifth region 22e may include a plurality of cut pattern segments having the dimensions specified above. The number of cut pattern segments in the fifth region 22e may be between 1 and 40. Each cut pattern segment in the fifth region 22e has a segment length that may be between 1.25 mm and 1.75 mm, preferably about 1.53 mm. The fifth region 22e may include a plurality of non-cut segments 34, each non-cut segment 34 defining a non-cut segment length that may be between 0.05 mm and 0.15 mm, preferably about 0.1 mm.
[0145] This fifth region 22e may have an average flexibility of about 1.68 gF / mm to about 3.68 gF / mm.
[0146] Continuing with this example of an exemplary medical device, the catheter body 12 may include a sixth section 22f located proximal to the fifth section 22e. The sixth section 22f may include at least one cut pattern segment 24f having a plurality of circumferentially spaced apart cuts 26 having a cut width that may be between 0.02 mm and 0.04 mm, preferably about 0.028 mm. The sixth section 22f may define a plurality of circumferentially spaced apart fillers 30 having a width that may be between 0.07 mm and 0.1 mm, preferably about 0.089 mm.
[0147] Each of the plurality of cuts 26 and the plurality of fillers 30 may have a pitch angle α that may be between 22 degrees and 32 degrees, preferably about 27 degrees. Cut pattern segment 24f may include 16-24 cuts and 16-24 fillers. Cut pattern segment 24f may preferably include 18 cuts and 18 fillers.
[0148] The sixth region 22f may include a plurality of cut pattern segments having the dimensions specified above. The number of cut pattern segments in the sixth region 22f may be between 1 and 40. Each cut pattern segment in the sixth region 22f has a segment length that may be between 1.25 mm and 1.75 mm, preferably about 1.52 mm. The sixth region 22f may include a plurality of non-cut segments 34, each non-cut segment 34 defining a non-cut segment length that may be between 0.05 mm and 0.15 mm, preferably about 0.1 mm.
[0149] The sixth section 22f may have an average flexibility of about 3.68 gF / mm to about 4.56 gF / mm.
[0150] Continuing with this example, the catheter body 12 may include a seventh section 22g located proximal to the sixth section 22f. The seventh section 22g may include at least one cut pattern segment 24g having a plurality of circumferentially spaced apart cuts 26 having a cut width that may be between 0.02 mm and 0.04 mm, preferably about 0.029 mm. The seventh section 22g may define a plurality of circumferentially spaced apart fillers 30 having a width that may be between 0.075 mm and 0.10 mm, preferably about 0.091 mm.
[0151] Each of the plurality of cuts 26 and the plurality of fillers 30 may have a pitch angle α that may be between 15 degrees and 25 degrees, preferably about 20 degrees. Cut pattern segment 24g may include 16-24 cuts and 16-24 fillers. Cut pattern segment 24g may preferably include 18 cuts and 18 fillers.
[0152] The seventh region 22g may include a plurality of cut pattern segments having the dimensions specified above. The number of cut pattern segments in the seventh region 22g may be between 1 and 40. Each cut pattern segment in the seventh region 22g has a segment length that may be between 1.25 mm and 1.75 mm, preferably about 1.52 mm. The seventh region 22g may include a plurality of non-cut segments 34, each non-cut segment 34 defining a non-cut segment length that may be between 0.05 mm and 0.15 mm, preferably about 0.1 mm.
[0153] The seventh section 22g may have an average flexibility of about 4.56 gF / mm to about 6.08 gF / mm.
[0154] In another example, the catheter body 12 can have an inner diameter of 0.45 mm to 0.65 mm, an outer diameter of 0.7 mm to 0.8 mm, and / or a wall thickness of 0.08 mm to 0.13 mm. Variations of the dimensions and patterns described herein can be incorporated into devices of all applicable inner and outer diameters, including those ranging from 3 French to 34 French.
[0155] In this example, the catheter body 12 may include a first section 22a at or near a distal portion of the medical device 10. The first section 22a may include at least one cut pattern segment 24a having a plurality of circumferentially spaced apart cuts 26 having a cut width that may be between 0.01 mm and 0.03 mm, preferably about 0.02 mm. The first section 22a may define a plurality of circumferentially spaced apart fillers 30 having a width that may be between 0.04 mm and 0.06 mm, preferably about 0.049 mm.
[0156] Each of the plurality of cuts 26 and the plurality of fillers 30 may have a pitch angle α that may be between 55 degrees and 65 degrees, preferably about 60 degrees. Cut pattern segment 24a may include 16-24 cuts and 16-24 fillers. Cut pattern segment 24a may preferably include 20 cuts and 20 fillers.
[0157] The first region 22a may include a plurality of cut pattern segments having the dimensions specified above. The number of cut pattern segments in the first region 22a may be between 1 and 40. Each cut pattern segment in the first region 22a has a segment length that may be between 1.0 mm and 1.5 mm, preferably about 1.24 mm. The first region 22a may include a plurality of non-cut segments 34, each non-cut segment 34 defining a non-cut segment length that may be between 0.05 mm and 0.15 mm, preferably about 0.1 mm.
[0158] This first section 22a may have an average flexibility of about 0.008 gF / mm to about 0.16 gF / mm.
[0159] Continuing with this example of an exemplary medical device, the catheter body 12 may include a second section 22b located proximal to the first section 22a. The second section 22b may include at least one cut pattern segment 24b having a plurality of circumferentially spaced apart cuts 26 having a cut width that may be between 0.01 mm and 0.03 mm, preferably about 0.02 mm. The second section 22b may define a plurality of circumferentially spaced apart fillers 30 having a width that may be between 0.05 mm and 0.07 mm, preferably about 0.057 mm.
[0160] Each of the plurality of cuts 26 and the plurality of fillers 30 may have a pitch angle α that may be between 45 degrees and 55 degrees, preferably about 50 degrees. Cut pattern segment 24b may include 16-24 cuts and 16-24 fillers. Cut pattern segment 24b may preferably include 20 cuts and 20 fillers.
[0161] The second region 22b may include a plurality of cut pattern segments having the dimensions specified above. The number of cut pattern segments in the second region 22b may be between 1 and 40. Each cut pattern segment in the second region 22b has a segment length that may be between 1.25 mm and 1.75 mm, preferably about 1.5 mm. The second region 22b may include a plurality of non-cut segments 34, each non-cut segment 34 defining a non-cut segment length that may be between 0.05 mm and 0.15 mm, preferably about 0.1 mm.
[0162] This second region 22b may have an average flexibility of about 0.16 gF / mm to about 0.48 gF / mm.
[0163] Continuing with this example, the catheter body 12 may include a third section 22c located proximal to the second section 22b. The third section 22c may include at least one cut pattern segment 24c having a plurality of circumferentially spaced apart cuts 26 having a cut width that may be between 0.01 mm and 0.03 mm, preferably about 0.02 mm. The third section 22c may define a plurality of circumferentially spaced apart fillers 30 having a width that may be between 0.06 mm and 0.09 mm, preferably about 0.074 mm.
[0164] Each of the plurality of cuts 26 and the plurality of fillers 30 may have a pitch angle α that may be between 40 degrees and 50 degrees, preferably about 45 degrees. Cut pattern segment 24c may include 14 to 22 cuts and 14 to 22 fillers. Cut pattern segment 24c may preferably include 18 cuts and 18 fillers.
[0165] The third region 22c may include a plurality of cut pattern segments having the dimensions specified above. The number of cut pattern segments in the third region 22c may be between 1 and 40. Each cut pattern segment in the third region 22c has a segment length that may be between 1.25 mm and 1.75 mm, preferably about 1.5 mm. The third region 22c may include a plurality of non-cut segments 34, each non-cut segment 34 defining a non-cut segment length that may be between 0.05 mm and 0.15 mm, preferably about 0.1 mm.
[0166] This third section 22c may have an average flexibility of about 0.48 gF / mm to about 1.04 gF / mm.
[0167] Continuing with this example of an exemplary medical device, the catheter body 12 may include a fourth section 22d located proximal to the first section 22a. The fourth section 22d may include at least one cut pattern segment 24d having a plurality of circumferentially spaced apart cuts 26 having a cut width that may be between 0.01 mm and 0.03 mm, preferably about 0.2 mm. The fourth section 22b may define a plurality of circumferentially spaced apart fillers 30 having a width that may be between 0.07 mm and 0.09 mm, preferably about 0.082 mm.
[0168] Each of the plurality of cuts 26 and the plurality of fillers 30 may have a pitch angle α that may be between 35 degrees and 45 degrees, preferably about 40 degrees. Cut pattern segment 24d may include 16-24 cuts and 16-24 fillers. Cut pattern segment 24d may preferably include 18 cuts and 18 fillers.
[0169] The fourth region 22d may include a plurality of cut pattern segments having the dimensions specified above. The number of cut pattern segments in the fourth region 22d may be between 1 and 40. Each cut pattern segment in the fourth region 22d has a segment length that may be between 1.25 mm and 1.75 mm, preferably about 1.5 mm. The fourth region 22d may include a plurality of non-cut segments 34, each non-cut segment 34 defining a non-cut segment length that may be between 0.05 mm and 0.15 mm, preferably about 0.1 mm.
[0170] This fourth region 22d may have an average flexibility of about 1.04 gF / mm to about 1.84 gF / mm.
[0171] Continuing with this example, the catheter body 12 may include a fifth section 22e located proximal to the fourth section 22e. The fifth section 22e may include at least one cut pattern segment 24e having a plurality of circumferentially spaced apart cuts 26 having a cut width that may be between 0.01 mm and 0.03 mm, preferably about 0.02 mm. The fifth section 22e may define a plurality of circumferentially spaced apart fillers 30 having a width that may be between 0.07 mm and 0.11 mm, preferably about 0.09 mm.
[0172] Each of the plurality of cuts 26 and the plurality of fillers 30 may have a pitch angle α that may be between 28 degrees and 38 degrees, preferably about 33 degrees. Cut pattern segment 24e may include 12-24 cuts and 12-24 fillers. Cut pattern segment 24e may preferably include 18 cuts and 18 fillers.
[0173] The fifth region 22e may include a plurality of cut pattern segments having the dimensions specified above. The number of cut pattern segments in the fifth region 22e may be between 1 and 40. Each cut pattern segment in the fifth region 22e has a segment length that may be between 1.25 mm and 1.75 mm, preferably about 1.53 mm. The fifth region 22e may include a plurality of non-cut segments 34, each non-cut segment 34 defining a non-cut segment length that may be between 0.05 mm and 0.15 mm, preferably about 0.1 mm.
[0174] This fifth region 22e may have an average flexibility of about 1.84 gF / mm to about 3.6 gF / mm.
[0175] Continuing with this example of an exemplary medical device, the catheter body 12 may include a sixth section 22f located proximal to the fifth section 22e. The sixth section 22f may include at least one cut pattern segment 24f having a plurality of circumferentially spaced apart cuts 26 having a cut width that may be between 0.01 mm and 0.03 mm, preferably about 0.02 mm. The sixth section 22f may define a plurality of circumferentially spaced apart fillers 30 having a width that may be between 0.08 mm and 0.12 mm, preferably about 0.098 mm.
[0176] Each of the plurality of cuts 26 and the plurality of fillers 30 may have a pitch angle α that may be between 22 degrees and 32 degrees, preferably about 27 degrees. Cut pattern segment 24f may include 12-24 cuts and 12-24 fillers. Cut pattern segment 24f may preferably include 18 cuts and 18 fillers.
[0177] The sixth region 22f may include a plurality of cut pattern segments having the dimensions specified above. The number of cut pattern segments in the sixth region 22f may be between 1 and 40. Each cut pattern segment in the sixth region 22f has a segment length that may be between 1.25 mm and 1.75 mm, preferably about 1.52 mm. The sixth region 22f may include a plurality of non-cut segments 34, each non-cut segment 34 defining a non-cut segment length that may be between 0.05 mm and 0.15 mm, preferably about 0.1 mm.
[0178] The sixth section 22f may have an average flexibility of about 3.6 gF / mm to about 4.32 gF / mm.
[0179] Continuing with this example, the catheter body 12 may include a seventh section 22g located proximal to the sixth section 22f. The seventh section 22g may include at least one cut pattern segment 24g having a plurality of circumferentially spaced apart cuts 26 having a cut width that may be between 0.01 mm and 0.03 mm, preferably about 0.02 mm. The seventh section 22g may define a plurality of circumferentially spaced apart fillers 30 having a width that may be between 0.08 mm and 0.12 mm, preferably about 0.1 mm.
[0180] Each of the plurality of cuts 26 and the plurality of fillers 30 may have a pitch angle α that may be between 19 degrees and 29 degrees, preferably about 24 degrees. Cut pattern segment 24g may include 12-24 cuts and 12-24 fillers. Cut pattern segment 24g may preferably include 18 cuts and 18 fillers.
[0181] The seventh region 22g may include a plurality of cut pattern segments having the dimensions specified above. The number of cut pattern segments in the seventh region 22g may be between 1 and 40. Each cut pattern segment in the seventh region 22g has a segment length that may be between 1.25 mm and 1.75 mm, preferably about 1.52 mm. The seventh region 22g may include a plurality of non-cut segments 34, each non-cut segment 34 defining a non-cut segment length that may be between 0.05 mm and 0.15 mm, preferably about 0.1 mm.
[0182] The seventh section 22g may have an average flexibility of about 4.32 gF / mm to about 4.8 gF / mm.
[0183] In another example, the catheter body 12 can have an inner diameter of 1.25 mm to 1.75 mm, an outer diameter of 1.5 mm to 1.8 mm, and / or a wall thickness of 0.06 mm to 0.10 mm. Variations of the dimensions and patterns described herein can be incorporated into devices of all applicable inner and outer diameters, including those ranging from 3 French to 34 French.
[0184] In this example, the catheter body 12 may include a first section 22a at or near a distal portion of the medical device 10. The first section 22a may include at least one cut pattern segment 24a having a plurality of circumferentially spaced apart cuts 26 having a cut width that may be between 0.01 mm and 0.03 mm, preferably about 0.02 mm. The first section 22a may define a plurality of circumferentially spaced apart fillers 30 having a width that may be between 0.04 mm and 0.08 mm, preferably about 0.062 mm.
[0185] Each of the plurality of cuts 26 and the plurality of fillers 30 may have a pitch angle α that may be between 55 degrees and 65 degrees, preferably about 60 degrees. Cut pattern segment 24a may include 20-40 cuts and 20-40 fillers. Cut pattern segment 24a may preferably include 30 cuts and 30 fillers.
[0186] The first region 22a may include a plurality of cut pattern segments having the dimensions specified above. The number of cut pattern segments in the first region 22a may be between 1 and 40. Each cut pattern segment in the first region 22a has a segment length that may be between 1.5 mm and 2.5 mm, preferably about 1.9 mm. The first region 22a may include a plurality of non-cut segments 34, each non-cut segment 34 defining a non-cut segment length that may be between 0.25 mm and 0.5 mm, preferably about 0.36 mm.
[0187] This first section 22a may have an average flexibility of about 0.1 gF / mm to about 45 gF / mm.
[0188] Continuing with this example of an exemplary medical device, the catheter body 12 may include a second section 22b located proximal to the first section 22a. The second section 22b may include at least one cut pattern segment 24b having a plurality of circumferentially spaced apart cuts 26 having a cut width that may be between 0.01 mm and 0.03 mm, preferably about 0.02 mm. The second section 22b may define a plurality of circumferentially spaced apart fillers 30 having a width that may be between 0.1 mm and 0.2 mm, preferably about 0.14 mm.
[0189] Each of the plurality of cuts 26 and the plurality of fillers 30 may have a pitch angle α that may be between 45 degrees and 55 degrees, preferably about 50 degrees. Cut pattern segment 24b may include 16-24 cuts and 16-24 fillers. Cut pattern segment 24b may preferably include 20 cuts and 20 fillers.
[0190] The second region 22b may include a plurality of cut pattern segments having the dimensions specified above. The number of cut pattern segments in the second region 22b may be between 1 and 40. Each cut pattern segment in the second region 22b has a segment length that may be between 1.5 mm and 2.5 mm, preferably about 1.9 mm. The second region 22b may include a plurality of non-cut segments 34, each non-cut segment 34 defining a non-cut segment length that may be between 0.25 mm and 0.5 mm, preferably about 0.36 mm.
[0191] This second region 22b may have an average flexibility of about 45 gF / mm to about 154 gF / mm.
[0192] Continuing with this example, the catheter body 12 may include a third section 22c located proximal to the second section 22b. The third section 22c may include at least one cut pattern segment 24c having a plurality of circumferentially spaced apart cuts 26 having a cut width that may be between 0.01 mm and 0.03 mm, preferably about 0.02 mm. The third section 22c may define a plurality of circumferentially spaced apart fillers 30 having a width that may be between 0.1 mm and 0.3 mm, preferably about 0.17 mm.
[0193] Each of the plurality of cuts 26 and the plurality of fillers 30 may have a pitch angle α that may be between 35 degrees and 45 degrees, preferably about 40 degrees. Cut pattern segment 24c may include 16-24 cuts and 16-24 fillers. Cut pattern segment 24c may preferably include 20 cuts and 20 fillers.
[0194] The third region 22c may include a plurality of cut pattern segments having the dimensions specified above. The number of cut pattern segments in the third region 22c may be between 1 and 40. Each cut pattern segment in the third region 22c has a segment length that may be between 1.5 mm and 2.5 mm, preferably about 1.9 mm. The third region 22c may include a plurality of non-cut segments 34, each non-cut segment 34 defining a non-cut segment length that may be between 0.25 mm and 0.5 mm, preferably about 0.36 mm.
[0195] This third region 22c may have an average flexibility of about 154 gF / mm to about 223 gF / mm.
[0196] Continuing with this example of an exemplary medical device, the catheter body 12 may include a fourth section 22d located proximal to the first section 22a. The fourth section 22d may include at least one cut pattern segment 24d having a plurality of circumferentially spaced apart cuts 26 having a cut width that may be between 0.015 mm and 0.035 mm, preferably about 0.25 mm. The fourth section 22b may define a plurality of circumferentially spaced apart fillers 30 having a width that may be between 0.1 mm and 0.3 mm, preferably about 0.22 mm.
[0197] Each of the plurality of cuts 26 and the plurality of fillers 30 may have a pitch angle α that may be between 25 degrees and 35 degrees, preferably about 30 degrees. Cut pattern segment 24d may include 16-24 cuts and 16-24 fillers. Cut pattern segment 24d may preferably include 20 cuts and 20 fillers.
[0198] The fourth region 22d may include a plurality of cut pattern segments having the dimensions specified above. The number of cut pattern segments in the fourth region 22d may be between 1 and 40. Each cut pattern segment in the fourth region 22d has a segment length that may be between 1.5 mm and 2.5 mm, preferably about 2 mm. The fourth region 22d may include a plurality of non-cut segments 34, each non-cut segment 34 defining a non-cut segment length that may be between 0.25 mm and 0.5 mm, preferably about 0.36 mm.
[0199] This fourth region 22d may have an average flexibility of about 223 gF / mm to about 245 gF / mm.
[0200] 6A-6D show additional examples of cut pattern segments for the catheter body 12. For example, FIG. 6A shows a cut pattern segment having a plurality of circumferentially spaced apart cuts 26 having a cut width that may be 0.02 mm to 0.04 mm, preferably about 0.03 mm, and a plurality of circumferentially spaced apart fillers 30 having a width that may be 0.05 mm to 0.07 mm, preferably about 0.058 mm. Each of the plurality of cuts 26 and the plurality of fillers 30 can have a pitch angle α that may be 55 degrees to 65 degrees, preferably about 60 degrees. The cut pattern segment may include 25 to 35 cuts and 25 to 35 fillers, preferably including 30 cuts and 30 fillers. The segment may have a length of 2 mm to 3 mm.
[0201] FIG. 6B illustrates a cut pattern segment having a plurality of circumferentially spaced apart cuts 26 having a cut width that may be between 0.02 mm and 0.04 mm, preferably about 0.03 mm, and a plurality of circumferentially spaced apart fillers 30 having a width that may be between 0.07 mm and 0.09 mm, preferably about 0.08 mm. Each of the plurality of cuts 26 and the plurality of fillers 30 may have a pitch angle α that may be between 45 degrees and 55 degrees, preferably about 50 degrees. The cut pattern segment may include 25-35 cuts and 25-35 fillers, preferably including 30 cuts and 30 fillers. The segment may have a length of 4 mm to 6 mm.
[0202] FIG. 6C illustrates a cut pattern segment having a plurality of circumferentially spaced apart cuts 26 having a cut width that may be between 0.02 mm and 0.04 mm, preferably about 0.03 mm, and a plurality of circumferentially spaced apart fillers 30 having a width that may be between 0.08 mm and 0.12 mm, preferably about 0.1 mm. Each of the plurality of cuts 26 and the plurality of fillers 30 may have a pitch angle α that may be between 35 degrees and 45 degrees, preferably about 40 degrees. The cut pattern segment may include 25-35 cuts and 25-35 fillers, preferably including 30 cuts and 30 fillers. The segment may have a length of 6 mm to 8 mm.
[0203] FIG. 6D illustrates a cut pattern segment having a plurality of circumferentially spaced apart cuts 26 having a cut width that may be between 0.02 mm and 0.04 mm, preferably about 0.03 mm, and a plurality of circumferentially spaced apart fillers 30 having a width that may be between 0.10 mm and 0.15 mm, preferably about 0.12 mm. Each of the plurality of cuts 26 and the plurality of fillers 30 may have a pitch angle α that may be between 25 degrees and 35 degrees, preferably about 30 degrees. The cut pattern segment may include 25 to 35 cuts and 25 to 35 fillers, preferably including 30 cuts and 30 fillers. The segment may have a length between 8 mm and 12 mm.
[0204] 6E and 6F show examples of flattened depictions of the cut pattern segments disclosed herein, illustrating the significant variations in pitch angle and orientation of the cut pattern segments that can be implemented along the length of the medical device 10 to provide the desired properties disclosed herein.
[0205] Figures 6G and 6H show additional examples of cut pattern segments having significant changes in pitch angle and orientation of the cut pattern segments that may be implemented along the length of the medical device 10. For example, Figures 6G and 6H show examples where the pitch angle of the cuts and fillers changes dramatically between a first section 22a and an adjacent second section 22b to allow the catheter frame to be set from a straight position into a curved shape without compromising the cut pattern or lumen concentricity.
[0206] 6I and 6J show additional examples of cut pattern segments configured according to the principles and advantages disclosed herein. For example, FIG. 6I shows one example of a multi-filament cut pattern segment with interrupted spiral cuts between the fillers in a region to form an interrupted spiral cut pattern. The interrupted segments between the cuts can be staggered, parallel, or offset to various degrees relative to the interruption of adjacent cuts. This example of an interrupted cut pattern can be implemented with various configurations and dimensions of one or more regions described herein.
[0207] 6J shows an example of a multifilament cut pattern in one or more sections of a catheter body, where the helical length and width of one or more filaments in a single section differs from the width of one or more other filaments in the section. Varying widths of filaments in a section can be implemented to achieve a desired axial stiffness, flexibility, axial tensile strength, or other functional property as described herein, and can likewise be implemented with various configurations and dimensions of one or more sections as described herein.
[0208] 7-12, the catheter body may include a distal tip segment 40 at or near the most distal end of the catheter body 12. The distal tip segment 40 may include one or more cut pattern segments having a plurality of cuts 26 and fillers 30 as described herein. Individual pairs of fillers 30 within a cut pattern segment of the distal tip segment 40 may be bonded, joined, or otherwise formed together to terminate at a filler tip 42, thus eliminating the sharp leading edge of a "single wire tip". The filler tip 42 may be rounded or have an atraumatic profile so as not to penetrate one or more linings or protective layers of the medical device 10. Thus, the paired fillers 30 form a plurality of helical segments extending about the longitudinal axis 20 of the catheter body 12.
[0209] The filament / spiral segment pair may terminate at different lengths along the longitudinal axis of the catheter body 12, examples of which are shown in Figures 7-10. Alternatively, the filament / spiral segment pair of the distal tip segment 40 may terminate substantially in the same plane or at a single longitudinal location along the catheter body 12, as shown in Figures 11-12.
[0210] The direction of the pitch of the filaments 30 within a distal tip segment 40 may vary, and the amount of filaments 30 within the circumference of a particular distal tip segment 40 may also vary to provide desired properties. For example, the distal tip segment shown in Figures 7-10 includes 12 filaments that make up six pairs of helical segments with staggered termination points along the length of the distal tip segment 40. Such staggered terminations provide a gradual change in axial stiffness, allowing for a decrease in tip compliance from the segmented body of the catheter to the paired helical segments 40 and the molded tip body 44. Figure 11 shows an example of a distal tip segment 40 having 12 filaments that make up six pairs of helical segments that terminate together at a single location along the length of the distal tip segment 40. Figure 12 shows an example of a distal tip segment 40 having 10 filaments that make up five pairs of helical segments that terminate together at a single location along the length of the distal tip segment 40.
[0211] In one example, the distal tip segment 40 can include at least one cut pattern segment having a plurality of circumferentially spaced apart cuts 26 having a cut width between 0.025 mm and 0.1 mm, and a plurality of circumferentially spaced apart fillers 30 having a width between 0.02 mm and 0.05 mm. Each of the plurality of cuts 26 and the plurality of fillers 30 can have a pitch angle α between 50 degrees and 65 degrees. The distal tip segment 40 can include 16 to 24 cuts and 16 to 24 fillers. The distal tip segment 40 can have a segment length between 2 mm and 6 mm.
[0212] In another example, the distal tip segment 40 can include at least one cut pattern segment having a plurality of circumferentially spaced apart cuts 26 having a cut width between 0.07 mm and 0.12 mm and a plurality of circumferentially spaced apart fillers 30 having a width between 0.02 mm and 0.1 mm. Each of the plurality of cuts 26 and the plurality of fillers 30 can have a pitch angle α between 55 degrees and 65 degrees. The distal tip segment 40 can include 16 to 24 cuts and 16 to 24 fillers. The distal tip segment 40 can have a segment length between 1 mm and 4 mm.
[0213] In another example, the distal tip segment 40 can include at least one cut pattern segment having a plurality of circumferentially spaced apart cuts 26 having a cut width between 0.05 mm and 0.10 mm and a plurality of circumferentially spaced apart fillers 30 having a width between 0.02 mm and 0.05 mm. Each of the plurality of cuts 26 and the plurality of fillers 30 can have a pitch angle α between 55 degrees and 65 degrees. The distal tip segment 40 can include 16 to 24 cuts and 16 to 24 fillers. The distal tip segment 40 can have a segment length between 1 mm and 4 mm.
[0214] Further examples of distal tip segments 40 are shown in Figures 13A-13G having various static or progressive cut widths, pitch angles, filler widths and / or axial struts therebetween.
[0215] 14-17, there are shown graphs of test results recorded for examples of the medical device 10 and its components described herein. FIG. 14 shows data for a three-point bend test along the length of a catheter body having prescribable incremental flexibility along the length of the catheter body in the proximal to distal direction. FIG. 15 similarly shows data for a three-point bend test along the length of a catheter body having a polymer liner and jacket, the catheter body assembly having prescribable incremental flexibility along the length of the catheter body in the proximal to distal direction. FIG. 16 shows guidewire friction force data when the guidewire is removed from within a catheter body constructed as disclosed herein based on various distal trajectory contours simulating vascular anatomy, demonstrating ease of use in over-the-wire applications. The different simulated paths of catheter curvature for which friction forces were measured are shown in the pictorial representation of the test fixture labeled "A," "B," and "C."
[0216] 17 shows a graph of axial tensile force testing of a single-filament construction for an example of a catheter body (e.g., "multifilament") configured as disclosed herein. As shown by the graph, the multifilament construction provides increased axial tensile strength compared to a single-filament construction, which provides such improved axial tensile strength while maintaining high flexibility, as shown in other tables and graphs disclosed herein.
[0217] 18 shows a graph of torque transmission testing of a single filament structure for an example of a catheter body (e.g., "multifilament") configured as disclosed herein. As shown by the graph, the multifilament structure provides comparable torque response in both clockwise and counterclockwise transmission compared to the single filament structure, and the multifilament structure provides comparable torque transmission while also maintaining high flexibility as shown in other tables and graphs disclosed herein.
[0218] The above-described examples of medical device 10 and associated dimensions can be modified for different applications to match and / or accommodate use in different anatomies and / or different patients. One or more portions of device 10 may be radiopaque and / or include radiopaque markers to assist in medical imaging of the device during a procedure. Radiopaque features may be achieved, for example, by the use of marker bands, plating, inclusion or infusion of tantalum, platinum, gold, tungsten, bismuth and / or barium sulfate in or on one or more components of the device. Device 10 may also include one or more polymer liners and outer jackets, as well as coating(s) 44 on its surface 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 allow a continuous transition of flexibility compliance from the catheter shaft to the distal polymer tip.
[0219] Those skilled in the art will understand that the present disclosure is not limited to what has been specifically shown and described herein above. Furthermore, unless otherwise noted above to the contrary, it should be noted that all of the accompanying drawings are not to scale. Of note, system components are represented by conventional symbols in the drawings where appropriate, and only specific details pertinent to understanding the embodiments of the present disclosure are shown, so as not to obscure the present disclosure with details that will be readily apparent to those skilled in the art having the benefit of the description herein. Furthermore, although a particular embodiment or figure described herein may exhibit features that are not explicitly shown in other figures or embodiments, it will be understood that the features and components of the examples disclosed herein are not necessarily mutually exclusive, and may be included in various different combinations or configurations without departing from the scope and spirit of the present disclosure. Various modifications and variations are possible in light of the above teachings without departing from the scope and spirit of the present disclosure, which is limited only by the following claims.
Claims
1. A catheter comprising: A catheter tube, the catheter tube comprising: A proximal end; A distal end. A longitudinal axis; a lumen passing through it; a first area having a first cut pattern segment therein; Define the first cut pattern segment defines a plurality of first spiral cuts spaced around a circumference of the tube; each of the plurality of first spiral cuts defines a width between 0.015 mm and 0.040 mm; each of the plurality of first spiral cuts is spaced from an adjacent cut by a filler having a width between 0.015 mm and 0.125 mm; The catheter, wherein each of the plurality of first spiral cuts defines a pitch angle with the longitudinal axis of between 30 degrees and 70 degrees.
2. The catheter of claim 1 , wherein the first section has a stiffness of about 0.1 gF / mm to about 0.75 gF / mm.
3. The catheter of claim 1 , wherein the plurality of first spiral cuts comprises between 10 and 40 cuts.
4. The catheter of any one of claims 1 to 3, wherein the first section has a length of between 1 mm and 100 mm.
5. The catheter of any one of claims 1 to 4, wherein the catheter tube is constructed from Nitinol and has a wall thickness of about 0.0254 mm to about 0.254 mm.
6. The catheter of any one of claims 1 to 4, wherein the catheter tube is constructed from Inconel and has a wall thickness of about 0.0254 mm to about 0.254 mm.
7. The catheter of any one of claims 1 to 4, wherein the catheter tube is constructed from stainless steel and has a wall thickness of about 0.0254 mm to about 0.254 mm.
8. The catheter of any one of claims 1 to 7, wherein the distal end includes a tip segment having a plurality of helical segments extending about the longitudinal axis.
9. The catheter of claim 8 , wherein each helical segment includes two substantially parallel fillers connected at their distal ends.
10. The catheter of claim 9 , wherein the plurality of helical segments includes at least two helical segments.
11. The catheter of any one of claims 1 to 10, further comprising a polymeric liner disposed within the lumen.
12. The catheter of any one of claims 1 to 11, further comprising a polymer jacket disposed about an outer diameter of the cutting tube.
13. the catheter tube further comprising a second section having a second cut pattern segment therein; the second cut pattern segment defines a plurality of second cuts spaced around a circumference of the tube; each of the plurality of second cuts defines a width between 0.015 mm and 0.04 mm; each of the plurality of second incisions is spaced from an adjacent incision by a filler having a width between 0.015 mm and 0.125 mm; The catheter of any one of claims 1 to 12, wherein each of the plurality of second cuts defines a pitch angle with the longitudinal axis of between 45 degrees and 55 degrees.
14. The catheter of claim 13 , wherein the second section is located proximal to the first section.
15. The catheter of claim 13 or 14, wherein the second section has a stiffness of about 0.75 gF / mm to about 1.25 gF / mm.
16. The catheter of any one of claims 13 to 15, wherein the plurality of second incisions comprises 1 to 40 incisions.
17. The catheter of any one of claims 13 to 16, wherein the second section has a length of between 1 mm and 100 mm.
18. A catheter comprising: A catheter tube, the catheter tube comprising: A proximal end; A distal end. A longitudinal axis; a lumen passing through it; a first area having a first cut pattern segment therein, the first cut pattern segment defines a plurality of first cuts spaced around a circumference of the tube; the plurality of first incisions includes 16 to 24 incisions; a first section, each of the plurality of first cuts defining a pitch angle with the longitudinal axis of between 60 degrees and 70 degrees; a second area having a second cut pattern segment therein, the second cut pattern segment defines a plurality of second cuts spaced around a circumference of the tube; the plurality of second incisions includes 16 to 24 incisions; a second section, each of the plurality of second cuts defining a pitch angle with the longitudinal axis of between 45 degrees and 55 degrees; A catheter.
19. A catheter comprising: A catheter tube, the catheter tube comprising: A proximal end; A distal end. A longitudinal axis; a lumen passing through it; a first region having a first cut pattern segment therein, the first cut pattern segment defining a plurality of first cuts spaced about a circumference of the tube; Define A catheter, the distal end of which includes a tip segment having a plurality of helical segments extending about the longitudinal axis, each helical segment including two substantially parallel fillers connected at its distal end.
20. A catheter comprising: A catheter tube, the catheter tube comprising: A proximal end; A distal end. A longitudinal axis; a lumen passing through it; a first area having a first cut pattern segment therein; Define the first cut pattern segment defines a plurality of first spiral cuts spaced around a circumference of the tube; each of the plurality of first spiral cuts defines a width between 0.018 mm and 0.026 mm; each of the plurality of first spiral cuts is spaced from an adjacent cut by a filler having a width between 0.025 mm and 0.037 mm; The catheter, wherein each of the plurality of first spiral cuts defines a pitch angle with the longitudinal axis of between 58 degrees and 68 degrees.
21. The catheter of claim 20, wherein the first cut pattern segment has a length between 1.0 mm and 1.3 mm.
22. 22. The catheter of claim 20, wherein the first section includes a plurality of first cut pattern segments therein, each of the first cut pattern segments being spaced from an adjacent first cut pattern segment by a non-cut segment having a length between 0.06 mm and 0.1 mm.
23. The catheter of any one of claims 20 to 22, wherein the plurality of first spiral cuts comprises between 12 and 22 cuts.
24. The catheter of any one of claims 20 to 23, wherein the first section has a stiffness of about 0.1 gF / mm to about 0.16 gF / mm.
25. The catheter of any one of claims 20 to 24, wherein the catheter tube has an outer diameter of 0.6 mm to 0.7 mm.
26. The catheter of any one of claims 20 to 25, wherein the lumen has a diameter of 0.45 mm to 0.52 mm.
27. The catheter of any one of claims 20 to 26, wherein the catheter tube has a wall thickness of 0.07 mm to 0.1 mm.
28. the catheter tube further comprising a second section having a second cut pattern segment therein; the second cut pattern segment defines a plurality of second cuts spaced around a circumference of the tube; each of the plurality of second cuts defines a width between 0.018 mm and 0.026 mm; each of the plurality of second incisions is spaced from an adjacent incision by a filler having a width of 0.05 mm to 0.07 mm; The catheter of any one of claims 20 to 27, wherein each of the plurality of second cuts defines a pitch angle with the longitudinal axis of between 44 degrees and 54 degrees.
29. the catheter tube further comprising a third section having a third cut pattern segment therein; the third cut pattern segment defines a plurality of third cuts spaced around a circumference of the tube; each of the plurality of third cuts defines a width between 0.018 mm and 0.026 mm; each of the plurality of third incisions is spaced from an adjacent incision by a filler having a width between 0.05 mm and 0.12 mm; The catheter of claim 28, wherein each of the plurality of third incisions defines a pitch angle with the longitudinal axis of between 27 degrees and 37 degrees.
30. A catheter comprising: A catheter tube, the catheter tube comprising: A proximal end; A distal end. A longitudinal axis; a lumen passing through it; a first area having a first cut pattern segment therein; Define the first cut pattern segment defines a plurality of first spiral cuts spaced around a circumference of the tube; each of the plurality of first spiral cuts defines a width between 0.018 mm and 0.026 mm; each of the plurality of first spiral cuts is spaced from an adjacent cut by a filler having a width between 0.04 mm and 0.07 mm; The catheter, wherein each of the plurality of first spiral cuts defines a pitch angle with the longitudinal axis of between 70 degrees and 80 degrees.
31. The catheter of claim 30, wherein the first cut pattern segment has a length between 1.0 mm and 2.0 mm.
32. 32. The catheter of claim 30, wherein the first section includes a plurality of first cut pattern segments therein, each of the first cut pattern segments being spaced from an adjacent first cut pattern segment by a non-cut segment having a length between 0.05 mm and 0.15 mm.
33. The catheter of any one of claims 30 to 32, wherein the plurality of first spiral cuts comprises between 5 and 10 cuts.
34. The catheter of any one of claims 30 to 33, wherein the first section has a stiffness of about 0.1 gF / mm to about 0.16 gF / mm.
35. The catheter of any one of claims 30 to 34, wherein the catheter tube has an outer diameter of 0.65 mm to 0.78 mm.
36. The catheter of any one of claims 30 to 35, wherein the lumen has a diameter of 0.4 mm to 0.55 mm.
37. The catheter of any one of claims 30 to 36, wherein the catheter tube has a wall thickness of 0.05 mm to 0.11 mm.
38. the catheter tube further comprising a second section having a second cut pattern segment therein; the second cut pattern segment defines a plurality of second cuts spaced around a circumference of the tube; each of the plurality of second cuts defines a width between 0.018 mm and 0.026 mm; each of the plurality of second incisions is spaced from an adjacent incision by a filler having a width between 0.045 mm and 0.075 mm; The catheter of any one of claims 30 to 37, wherein each of the plurality of second cuts defines a pitch angle with the longitudinal axis of between 44 degrees and 54 degrees.
39. the catheter tube further comprising a third section having a third cut pattern segment therein; the third cut pattern segment defines a plurality of third cuts spaced around a circumference of the tube; each of the plurality of third cuts defines a width between 0.018 mm and 0.026 mm; each of the plurality of third incisions is spaced from an adjacent incision by a filler having a width between 0.07 mm and 0.10 mm; 39. The catheter of claim 38, wherein each of the plurality of third incisions defines a pitch angle with the longitudinal axis of between 27 degrees and 37 degrees.
40. A catheter comprising: A catheter tube, the catheter tube comprising: A proximal end; A distal end. A longitudinal axis; a lumen passing through it; a first area having a first cut pattern segment therein; Define the first cut pattern segment defines a plurality of first spiral cuts spaced around a circumference of the tube; each of the plurality of first spiral cuts defines a width between 0.015 mm and 0.024 mm; each of the plurality of first spiral cuts is spaced from an adjacent cut by a filler having a width between 0.025 mm and 0.045 mm; The catheter, wherein each of the plurality of first spiral cuts defines a pitch angle with the longitudinal axis of between 59 degrees and 69 degrees.
41. The catheter of claim 40, wherein the first cut pattern segment has a length between 1.0 mm and 1.3 mm.
42. 42. The catheter of claim 40 or 41, wherein the first section includes a plurality of first cut pattern segments therein, each of the first cut pattern segments being spaced from an adjacent first cut pattern segment by a non-cut segment having a length between 0.07 mm and 0.09 mm.
43. The catheter of any one of claims 40 to 42, wherein the plurality of first spiral cuts comprises between 15 and 25 cuts.
44. The catheter of any one of claims 40 to 43, wherein the first section has a stiffness of about 0.1 gF / mm to about 0.24 gF / mm.
45. The catheter of any one of claims 40 to 44, wherein the catheter tube has an outer diameter of 0.66 mm to 0.86 mm.
46. The catheter of any one of claims 40 to 45, wherein the lumen has a diameter of 0.43 mm to 0.63 mm.
47. The catheter of any one of claims 40 to 46, wherein the catheter tube has a wall thickness of 0.06 mm to 0.17 mm.
48. the catheter tube further comprising a second section having a second cut pattern segment therein; the second cut pattern segment defines a plurality of second cuts spaced around a circumference of the tube; each of the plurality of second cuts defines a width between 0.015 mm and 0.024 mm; each of the plurality of second incisions is spaced from an adjacent incision by a filler having a width of 0.05 mm to 0.07 mm; The catheter of any one of claims 40 to 47, wherein each of the plurality of second cuts defines a pitch angle with the longitudinal axis of between 43 degrees and 53 degrees.
49. the catheter tube further comprising a third section having a third cut pattern segment therein; the third cut pattern segment defines a plurality of third cuts spaced around a circumference of the tube; each of the plurality of third cuts defines a width between 0.018 mm and 0.028 mm; each of the plurality of third incisions is spaced from an adjacent incision by a filler having a width between 0.07 mm and 0.09 mm; 49. The catheter of claim 48, wherein each of the plurality of third incisions defines a pitch angle with the longitudinal axis of between 28 degrees and 38 degrees.
50. A catheter comprising: A catheter tube, the catheter tube comprising: A proximal end; A distal end. A longitudinal axis; a lumen passing through it; a first area having a first cut pattern segment therein; Define the first cut pattern segment defines a plurality of first spiral cuts spaced around a circumference of the tube; each of the plurality of first spiral cuts defines a width between 0.025 mm and 0.035 mm; each of the plurality of first spiral cuts is spaced from an adjacent cut by a filler having a width between 0.022 mm and 0.032 mm; The catheter, wherein each of the plurality of first spiral cuts defines a pitch angle with the longitudinal axis of between 59 degrees and 69 degrees.
51. 51. The catheter of claim 50, wherein the first cut pattern segment has a length between 1.15 mm and 1.35 mm.
52. 52. The catheter of claim 50 or 51, wherein the first section includes a plurality of first cut pattern segments therein, each of the first cut pattern segments being spaced from an adjacent first cut pattern segment by a non-cut segment having a length between 0.05 mm and 0.15 mm.
53. 53. The catheter of claim 50, wherein the plurality of first spiral cuts comprises between 16 and 24 cuts.
54. 54. The catheter of any one of claims 50 to 53, wherein the first section has a stiffness of about 0.01 gF / mm to about 0.08 gF / mm.
55. The catheter of any one of claims 50 to 54, wherein the catheter tube has an outer diameter of 0.7 mm to 0.8 mm.
56. 56. The catheter of any one of claims 50 to 55, wherein the lumen has a diameter of 0.45 mm to 0.65 mm.
57. A catheter according to any one of claims 50 to 56, wherein the catheter tube has a wall thickness of 0.08 mm to 0.13 mm.
58. the catheter tube further comprising a second section having a second cut pattern segment therein; the second cut pattern segment defines a plurality of second cuts spaced around a circumference of the tube; each of the plurality of second cuts defines a width between 0.027 mm and 0.037 mm; each of the plurality of second incisions is spaced from an adjacent incision by a filler having a width between 0.038 mm and 0.048 mm; 58. The catheter of claim 50, wherein each of the plurality of second cuts defines a pitch angle with the longitudinal axis of between 45 degrees and 55 degrees.
59. the catheter tube further comprising a third section having a third cut pattern segment therein; the third cut pattern segment defines a plurality of third cuts spaced around a circumference of the tube; each of the plurality of third incisions defines a width between 0.02 mm and 0.04 mm; each of the plurality of third incisions is spaced from an adjacent incision by a filler having a width between 0.055 mm and 0.075 mm; 60. The catheter of claim 58, wherein each of the plurality of third incisions defines a pitch angle with the longitudinal axis of between 40 degrees and 50 degrees.
60. A catheter comprising: A catheter tube, the catheter tube comprising: A proximal end; A distal end. A longitudinal axis; a lumen passing through it; a first area having a first cut pattern segment therein; Define the first cut pattern segment defines a plurality of helical first cuts spaced around a circumference of the tube; each of the plurality of spiral first cuts defines a width between 0.01 mm and 0.03 mm; each of the plurality of spiral first cuts is spaced from an adjacent cut by a filler having a width of 0.04 mm to 0.06 mm; The catheter, wherein each of the plurality of helical first cuts defines a pitch angle with the longitudinal axis of between 55 degrees and 65 degrees.
61. 61. The catheter of claim 60, wherein the first cut pattern segment has a length between 1.0 mm and 1.5 mm.
62. 62. A catheter according to any one of claims 60 or 61, wherein the first section includes a plurality of first cut pattern segments therein, each of the first cut pattern segments being spaced from an adjacent first cut pattern segment by a non-cut segment having a length of between 0.05 mm and 0.15 mm.
63. 63. The catheter of any one of claims 60-62, wherein the plurality of first spiral cuts comprises between 16 and 24 cuts.
64. 64. The catheter of any one of claims 60 to 63, wherein the first section has a stiffness of about 0.008 gF / mm to about 0.16 gF / mm.
65. The catheter of any one of claims 60 to 64, wherein the catheter tube has an outer diameter of 0.7 mm to 0.8 mm.
66. 66. The catheter of any one of claims 60 to 65, wherein the lumen has a diameter of 0.45 mm to 0.65 mm.
67. 67. The catheter of any one of claims 60 to 66, wherein the catheter tube has a wall thickness of 0.08 mm to 0.13 mm.
68. the catheter tube further comprising a second section having a second cut pattern segment therein; the second cut pattern segment defines a plurality of second cuts spaced around a circumference of the tube; each of the plurality of second incisions defines a width between 0.01 mm and 0.03 mm; each of the plurality of second incisions is spaced from an adjacent incision by a filler having a width of 0.05 mm to 0.07 mm; 68. The catheter of any one of claims 60 to 67, wherein each of the plurality of second cuts defines a pitch angle with the longitudinal axis of between 45 degrees and 55 degrees.
69. the catheter tube further comprising a third section having a third cut pattern segment therein; the third cut pattern segment defines a plurality of third cuts spaced around a circumference of the tube; each of the plurality of third incisions defines a width between 0.01 mm and 0.03 mm; each of the plurality of third incisions is spaced from an adjacent incision by a filler having a width between 0.06 mm and 0.09 mm; 69. The catheter of claim 68, wherein each of the plurality of third incisions defines a pitch angle with the longitudinal axis of between 40 degrees and 50 degrees.
70. A catheter comprising: A catheter tube, the catheter tube comprising: A proximal end; A distal end. A longitudinal axis; a lumen passing through it; a first area having a first cut pattern segment therein; Define the first cut pattern segment defines a plurality of first spiral cuts spaced around a circumference of the tube; each of the plurality of first spiral cuts defines a width between 0.01 mm and 0.03 mm; each of the plurality of first spiral cuts is spaced from an adjacent cut by a filler having a width between 0.04 mm and 0.08 mm; The catheter, wherein each of the plurality of first spiral cuts defines a pitch angle with the longitudinal axis of between 55 degrees and 65 degrees.
71. 71. The catheter of claim 70, wherein the first cut pattern segment has a length between 1.5 mm and 2.5 mm.
72. 72. The catheter of claim 70 or 71, wherein the first section includes a plurality of first cut pattern segments therein, each of the first cut pattern segments being spaced from an adjacent first cut pattern segment by a non-cut segment having a length between 0.25 mm and 0.5 mm.
73. 73. The catheter of claim 70, wherein the plurality of first spiral cuts comprises between 20 and 40 cuts.
74. 74. The catheter of any one of claims 70 to 73, wherein the first section has a stiffness of about 0.1 gF / mm to about 45 gF / mm.
75. The catheter of any one of claims 70 to 74, wherein the catheter tube has an outer diameter of 1.5 mm to 1.8 mm.
76. 76. The catheter of any one of claims 70 to 75, wherein the lumen has a diameter of 1.25 mm to 1.75 mm.
77. A catheter according to any one of claims 70 to 76, wherein the catheter tube has a wall thickness of 0.06 mm to 0.10 mm.
78. the catheter tube further comprising a second section having a second cut pattern segment therein; the second cut pattern segment defines a plurality of second cuts spaced around a circumference of the tube; each of the plurality of second incisions defines a width between 0.01 mm and 0.03 mm; each of the plurality of second incisions is spaced from an adjacent incision by a filler having a width of 0.1 mm to 0.2 mm; The catheter of any one of claims 70 to 77, wherein each of the plurality of second cuts defines a pitch angle with the longitudinal axis of between 45 degrees and 55 degrees.
79. the catheter tube further comprising a third section having a third cut pattern segment therein; the third cut pattern segment defines a plurality of third cuts spaced around a circumference of the tube; each of the plurality of third incisions defines a width between 0.01 mm and 0.03 mm; each of the plurality of third incisions is spaced from an adjacent incision by a filler having a width of 0.1 mm to 0.3 mm; 79. The catheter of claim 78, wherein each of the plurality of third incisions defines a pitch angle with the longitudinal axis of between 35 degrees and 45 degrees.
80. A catheter comprising: A catheter tube, the catheter tube comprising: A proximal end; A distal end. A longitudinal axis; a lumen passing through it; a first area having a first cut pattern segment therein; Define the first cut pattern segment defines a plurality of first spiral cuts spaced around a circumference of the tube; the distal end includes a tip segment having a plurality of helical segments extending about the longitudinal axis, each helical segment including two substantially parallel fillers connected at a distal end thereof; the two substantially parallel fillets of each helical segment having a width of between 0.02 mm and 0.05 mm; the two substantially parallel fillers of each helical segment are spaced apart from each other by a cut width of 0.025 mm to 0.1 mm; The catheter, wherein each of the helical segments defines a pitch angle with the longitudinal axis of between 50 degrees and 65 degrees.
81. The catheter of claim 80, wherein the tip segment comprises between 16 and 24 filaments.
82. 82. The catheter of claim 80, wherein the tip segment has a length of between 2 mm and 6 mm.
83. A catheter comprising: A catheter tube, the catheter tube comprising: A proximal end; A distal end. A longitudinal axis; a lumen passing through it; a first area having a first cut pattern segment therein; Define the first cut pattern segment defines a plurality of first spiral cuts spaced around a circumference of the tube; the distal end includes a tip segment having a plurality of helical segments extending about the longitudinal axis, each helical segment including two substantially parallel fillers connected at a distal end thereof; the two substantially parallel fillets of each helical segment having a width of between 0.02 mm and 0.1 mm; the two substantially parallel fillers of each helical segment are spaced apart from each other by a cut width of 0.07 mm to 0.12 mm; The catheter, wherein each of the helical segments defines a pitch angle with the longitudinal axis of between 55 degrees and 65 degrees.
84. The catheter of claim 83, wherein the tip segment comprises between 16 and 24 filaments.
85. 85. The catheter of claim 83, wherein the tip segment has a length of 1 mm to 4 mm.
86. A catheter comprising: A catheter tube, the catheter tube comprising: A proximal end; A distal end. A longitudinal axis; a lumen passing through it; a first area having a first cut pattern segment therein; Define the first cut pattern segment defines a plurality of first spiral cuts spaced around a circumference of the tube; the distal end includes a tip segment having a plurality of helical segments extending about the longitudinal axis, each helical segment including two substantially parallel fillers connected at a distal end thereof; the two substantially parallel fillets of each helical segment having a width of between 0.02 mm and 0.05 mm; the two substantially parallel fillers of each helical segment are spaced apart from each other by a cut width of 0.05 mm to 0.10 mm; The catheter, wherein each of the helical segments defines a pitch angle with the longitudinal axis of between 55 degrees and 65 degrees.
87. The catheter of claim 86, wherein the tip segment comprises between 16 and 24 filaments.
88. 88. The catheter of claim 86, wherein the tip segment has a length of 1 mm to 4 mm.