Catheter tip shaping tool

Abstract

The catheter tip shaping system includes a catheter (320) and a tip shaping tool (100). The tip shaping tool includes a body 120 having a first end (121) and a second end (123), and a first pin (130a), a second pin (130b), and a third pin (130c), the first, second, and third pins being disposed at the first end of the body and extending from a first surface of the body. The distal end region of the catheter may be configured to be disposed within a gap between the first, second, and third pins such that the tip shaping tool can be manipulated by a user to generate a curvature in the distal end region of the catheter.

Description

[Technical Field]

[0001] The present disclosure relates to catheters and related accessories for delivering therapeutic agents or devices to sites within body lumens. More particularly, the present disclosure relates to catheters and tipping tools for catheters. [Background technology]

[0002] Various intravascular catheters are known, including small-diameter catheters with a central lumen therethrough that are configured for use in smaller vasculature. Such catheters are known as microcatheters. Microcatheters are typically highly flexible and thin-walled, which can result in limited torque transmission from the proximal hub to the distal tip, reduced kink resistance, and difficulty navigating tortuous vasculature. Typically, the tip of a microcatheter must be shaped to navigate such tortuous vasculature. Current methods include steam shaping and hand shaping. However, these methods are time-consuming, lack precision in the desired angle, and can even result in tip damage. There remains a need for improved catheter tip shaping tools and methods that reduce time consumption and damage while increasing torque transmission and kink resistance.

[0003] There is a continuing need to provide alternative medical devices and alternative methods for making and using medical devices. Summary of the Invention

[0004] The present disclosure provides design, material, manufacturing, and use alternatives for medical devices. An example of a medical device may include a catheter tip shaping system, which may include a catheter and a tip shaping tool. The tip shaping tool may include a body having a first end and a second end, and a first pin, a second pin, and a third pin, the first pin, the second pin, and the third pin disposed at the first end of the body and extending from a first surface of the body. The distal end region of the catheter may be configured to be positioned between a gap between the first, second, and third pins such that the tip shaping tool can be manipulated by a user to generate a curvature in the distal end region of the catheter.

[0005] Alternatively or additionally to any of the above embodiments, the first, second and third pins may be positioned equidistant from each other. Alternatively, or in addition to, any of the above embodiments, the distance between each of the first, second, and third pins may be between about 0.025 inches (about 0.635 mm) and about 0.045 inches (about 1.143 mm).

[0006] Alternatively or additionally to any of the above embodiments, the body may include a grip portion to be grasped by a user. Alternatively, or in addition to, any of the above embodiments, the first, second, and third pins may each include a circular cross-section.

[0007] Alternatively or additionally to any of the above embodiments, the first, second, and third pins may each include a first end region and a second end region, the first end region including a first outer diameter and the second end region including a second outer diameter, the first outer diameter being larger than the second outer diameter.

[0008] Alternatively, or in addition to, any of the above embodiments, the second end regions of the first, second, and third pins may be coupled to a first end of the body of the tip forming tool with the second end regions of the first, second, and third pins disposed between the first surface of the body and the first end regions of the first, second, and third pins.

[0009] Alternatively, or in addition to, any of the above embodiments, the gap between the first end regions of the first, second, and third pins may be smaller than the outer diameter of the distal end region of the catheter, and the gap between the second end regions of the first, second, and third pins may be larger than the outer diameter of the distal end region of the catheter.

[0010] Alternatively, or in addition to any of the above embodiments, the length of the second end region of the first, second and third pins may be greater than the outer diameter of the distal end region of the catheter. Alternatively, or in addition to, any of the above embodiments, when the distal end region of the catheter is positioned within the gap, the first pin may be positioned on a first side of the distal end region of the catheter, and the second and third pins may be positioned on a second, opposite side of the distal end region of the catheter.

[0011] Alternatively, or in addition to, any of the above embodiments, the body may be configured to be rotated to generate a curvature in the distal end region. Alternatively or additionally to any of the above embodiments, the first pin may be located on the concave side of the curve, and the second and third pins are located on the convex side of the curve.

[0012] Alternatively or additionally to any of the above embodiments, the catheter may include an elongate shaft having a distal end and a proximal end. The elongate shaft may include an outer layer formed from a polymer, an inner layer formed from a polymer, and a middle layer formed from a braid having a plurality of strands. Each strand may include a plurality of metal filaments, e.g., at least two, at least three, or at least four metal filaments each. A polymeric distal tip may be attached to the distal end of the elongate shaft.

[0013] A method for shaping a distal end of a catheter using a tip shaping tool may include inserting a distal end region of the catheter into gaps between first, second, and third pins of the tip shaping tool. The tip shaping tool may include a body having a first end and a second end, and the first, second, and third pins may be disposed at the first end of the body and extend from a first surface of the body. The method may further include rotating the tip shaping tool to move the distal end region of the catheter from a first straight configuration to a second curved configuration and removing the distal end region of the catheter from the tip shaping tool, wherein the tip shaping tool may be rotated in a clockwise and / or counterclockwise position.

[0014] Alternatively, or in addition to, any of the above embodiments, when the distal end of the catheter is inserted into the gap of the tip forming tool, the first pin may be located on a first side of the distal end region of the catheter, and the second and third pins are located on a second, opposite side of the distal end region of the catheter.

[0015] Alternatively, or in addition to, any of the above embodiments, the first pin may be located on the concave side of the distal end region of the second curved configuration, and the second and third pins are located on the convex side of the distal end region of the second curved configuration.

[0016] Alternatively, or in addition to, any of the above embodiments, when the distal end region of the catheter is inserted into the tip shaping tool, the end of a marker band located on the catheter may be aligned with the edge of the first end of the tip shaping tool before rotating the tip shaping tool.

[0017] In another example, a catheter tip shaping tool may include a body having a first end and a second end, and a first pin, a second pin, and a third pin, the first pin, the second pin, and the third pin being disposed at the first end of the body and extending from a first surface of the body.

[0018] Alternatively or additionally to any of the above embodiments, the first, second and third pins may be positioned equidistant from each other. Alternatively or additionally to any of the above embodiments, the first, second, and third pins may each include a first end region and a second end region, the first end region being disposed between the first face of the body and the second end region, and the first end region including an outer diameter smaller than an outer diameter of the second end region.

[0019] The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The following figures and detailed description more particularly exemplify these embodiments.

[0020] The present disclosure may be more fully understood by considering the following detailed description in conjunction with the accompanying drawings, in which: [Brief explanation of the drawings]

[0021] [Figure 1] FIG. [Figure 2] Figure 1. Side view of the tip shaping tool. [Figure 3] Figure 1. End view of the tip shaping tool. [Figure 4] FIG. [Figure 5]Figure 4. Side view of the tip shaping tool. [Figure 6] Figure 4. End view of the tip shaping tool. [Figure 7] 6 is an enlarged view of the first end of the tip shaping tool as in FIG. 5, including the catheter. [Figure 8A] 10A-10C illustrate an exemplary method of using a tip shaping tool with a catheter. [Figure 8B] 10A-10C illustrate an exemplary method of using a tip shaping tool with a catheter. [Figure 9] 10 is an exemplary graph comparing tip angle maintenance between a catheter tip shaped using a tip shaping tool according to the present disclosure and a pre-shaped catheter tip. [Figure 10] FIG. 2 is a partial view of an elongate shaft of a catheter according to one embodiment of the present disclosure, showing the outer, middle, and inner layers of the elongate shaft. [Figure 11] FIG. 10 is a partial view of the braiding of the elongate shaft of a catheter according to an embodiment of the present disclosure. [Figure 12] FIG. 1 shows a kit including a catheter and a tip forming tool. DETAILED DESCRIPTION OF THE INVENTION

[0022] While the present disclosure is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the disclosure to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit of the disclosure.

[0023] For the terms defined below, these definitions shall apply unless a different definition is given in the claims or elsewhere in this specification. All numerical values ​​herein are assumed to be modified by the term "about," whether expressly stated or not. The term "about" generally refers to a range of numerical values ​​that one of ordinary skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many cases, the term "about" may include numbers rounded to the nearest significant figure. The recitation of numerical ranges by endpoints includes all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in its sense to include "and / or" unless the content clearly dictates otherwise. It should be noted that references herein to "one embodiment," "some embodiments," "other embodiments," etc., indicate that the described embodiment may include one or more particular features, structures, and / or characteristics. However, such a description does not necessarily mean that all embodiments include the particular feature, structure, and / or characteristic. In addition, if a particular feature, structure, and / or characteristic is described in connection with one embodiment, it should be understood that such feature, structure, and / or characteristic may also be used in connection with other embodiments, whether or not explicitly described, unless expressly stated to the contrary.

[0024] The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the claims.

[0025] Catheters are typically highly flexible and thin-walled, which can result in limited torque transmission from the proximal hub to the distal tip, reduced kink resistance, and difficulty navigating through tortuous vasculature. Furthermore, the tip of the catheter often needs to be shaped to navigate such tortuous vasculature. Other medical devices, such as guidewires, microcatheters, etc., may also require tip shaping before use. Current shaping methods may include steam shaping and hand shaping. However, these methods can be time-consuming and may result in tip damage. The ability to shape medical devices without using steam may be desirable.

[0026] FIG. 1 is a perspective view of tip shaping tool 100, FIG. 2 is a side view of tip shaping tool 100, and FIG. 3 is an end view of tip shaping tool 100. Tip shaping tool 100 may include a body 120 having a first end 121 and a second end 123. Tip shaping tool 100 may have any desired length and diameter. For example, tip shaping tool 100 may have a length ranging from approximately 2 centimeters to 8 centimeters and an outer diameter (OD) ranging from approximately 0.6 centimeters to 1.5 centimeters. Tip shaping tool 100 may be formed from a rigid material, such as a polymeric and / or metallic material (e.g., acrylonitrile butadiene styrene, thermoplastics, other polymers, glass, metals, alloys, ceramics, etc.). However, other embodiments may include tip shaping tool 100 made from a flexible or semi-rigid material, such as a flexible or semi-rigid plastic material, or any other suitable type of material, such as those further disclosed herein. Furthermore, tipping tool 100 may be formed by any suitable manufacturing technique, including extrusion, co-extrusion, molding, casting, 3D printing, machining, and the like.

[0027] The body 120 of the tip shaping tool 100 may have any desired shape or geometry. For example, the body 120 may include a generally cylindrical shape, as shown in FIGS. 1-3 . In some cases, the body 120 of the tip shaping tool 100 may include a rectangular, square, oval, or any other suitable shape, as desired. The body 120 may further include a grip portion 124 disposed between the first end 121 and the second end 123. The grip portion 124 may be configured to be grasped by a user during use. For example, the grip portion 124 may include one or more recesses 127, which may include a shape and size configured for a user's thumb and / or fingers. In some cases, the grip portion 124 may not include one or more recesses 127; rather, the body 120 may include one or more protrusions, flat surfaces, or the body 120 may include a continuous cylindrical shape or any other desired shape.

[0028] A plurality of pins may extend from the first end 121 of the body 120. For example, a first pin 130a, a second pin 130b, and a third pin 130c may be disposed at the first end 121 of the body 120 and may extend from the first surface 122 of the body 120. The first pin 130a, the second pin 130b, and the third pin 130c each include a first end region 131a, 131b, and 131c, respectively, and a second end region 133a, 133b, and 133c, respectively. The second end regions 133a, 133b, and 133c may be coupled to the first end 121 of the body 120 of the tip forming tool 100, with the second end regions 133a, 133b, and 133c disposed between the first surface 122 of the body 120 and the first end regions 131a, 131b, and 131c. As shown in FIGS. 1-3 , the first pin 130a, the second pin 130b, and the third pin 130c may each include a circular cross-section. However, in other examples, one or more of the first pin 130a, the second pin 130b, and / or the third pin 130c may include a different cross-sectional shape. For example, while the first pin 130a, the second pin 130b, and the third pin 130c are illustrated as including a circular cross-section, it is contemplated that the first pin 130a, the second pin 130b, and the third pin 130c may include a rectangular cross-section, a square cross-section, a triangular cross-section, or some other suitable cross-section. In some cases, the first pin 130a may include a circular cross-section, and the second pin 130b and the third pin 130c may include a cross-sectional shape that is different from the cross-sectional shape of the first pin 130a. In some cases, one or more sides of the first pin 130a, the second pin 130b, and / or the third pin 130c may be convex or arcuate. In some cases, it may be envisioned that the first pin 130a, the second pin 130b, and the third pin 130c may each include a different cross-sectional shape from one another. These are merely examples.

[0029] In some cases, the first pin 130a, the second pin 130b, and the third pin 130c may be positioned equidistant from one another. For example, as shown in FIG. 3, the body 120 may include a central rotational axis 125, and the first pin 130a, the second pin 130b, and the third pin 130c may each be positioned equidistant from one another about the central rotational axis 125. Furthermore, the first pin 130a, the second pin 130b, and the third pin 130c may each be positioned equidistant from the central rotational axis 125. In some cases, the first pin 130a, the second pin 130b, and the third pin 130c may not be equidistant from one another, and / or one or more of the first pin 130a, the second pin 130b, and the third pin 130c may be positioned farther from the central rotation axis 125 than another one of the first pin 130a, the second pin 130b, and the third pin 130c. The distance between each of the first pin 130a, the second pin 130b, and the third pin 130c may comprise a distance configured to accommodate a catheter positioned therebetween. In some cases, the gap 134 between the first pin 130a, the second pin 130b, and the third pin 130c may comprise an equidistance between the first end regions 131a, 131b, 131c and the second end regions 133a, 133b, 133c. The pins 130a, 130b, 130c may be positioned such that the distance between each of the first pin 130a, the second pin 130b, and the third pin 130c may be slightly greater than the outer diameter of the associated catheter. For example, in some cases, the catheter may be a microcatheter, and the distance between each of the first pin 130a, the second pin 130b, and the third pin 130c may comprise a distance of about 0.025 inches (about 0.635 mm) to about 0.045 inches (about 1.143 mm). In some cases, the distance between the first pin 130a, the second pin 130b, and the third pin 130c may comprise a distance of about 0.04 inches (about 1.016 mm) to about 0.06 inches (about 1.524 mm). In some cases, the distance between the first pin 130a, the second pin 130b, and the third pin 130c may be about 0.03 inches (about 0.762 mm). These are just examples.

[0030] In some cases, during use, as further described with reference to FIGS. 8A-8B , when the distal end region of the catheter is disposed within gap 134, first pin 130a may be disposed on a first side of the distal end region of the catheter, and second pin 130b and third pin 130c may be disposed on an opposite, second side of the distal end region of the catheter. When the catheter is disposed within gap 134, body 120 of tip shaping tool 100 may be configured to be manipulated to generate a curvature in the distal end region of the catheter, for example, by rotating it about central rotation axis 125. In some cases, tip shaping tool 100 may be rotated in a clockwise position. In some cases, tip shaping tool 100 may be rotated in a counterclockwise position.

[0031] FIG. 4 is a perspective view of the tip shaping tool 200, FIG. 5 is a side view of the tip shaping tool 200 of FIG. 4, and FIG. 6 is a top view of the tip shaping tool 200 of FIG. 4. In many respects, the tip shaping tool 200 may be similar to the tip shaping tool 100 described above. For example, the tip shaping tool 200 may include a body 220 having a first end 221 and a second end 223. The tip shaping tool 200 may have any desired length and diameter. For example, the tip shaping tool 200 may have a length ranging from about 2 centimeters to 8 centimeters and an outer diameter (OD) of, for example, about 0.6 centimeters to 1.5 centimeters. The tip shaping tool 200 may be formed from a rigid material, such as a polymeric and / or metallic material (e.g., acrylonitrile butadiene styrene, thermoplastics, other polymers, glass, metals, alloys, ceramics, etc.). However, other embodiments may include tip shaping tool 200 made from a flexible or semi-rigid material, such as a flexible or semi-rigid plastic material, or any other suitable type of material, such as those further disclosed herein. Additionally, tip shaping tool 200 may be formed by any suitable manufacturing technique, including extrusion, co-extrusion, molding, casting, 3D printing, machining, etc.

[0032] The body 220 of the tip shaping tool 200 may have any desired shape or geometry. For example, the body 220 may include a generally cylindrical shape, as shown in FIGS. 4-6. In some cases, the body 220 of the tip shaping tool 200 may include a rectangular, square, oval, or any other suitable shape, as desired. The body 220 may further include a grip portion 224 disposed between the first end 221 and the second end 223. The grip portion 224 may be configured to be grasped by a user during use. For example, the grip portion 224 may include a roughened pattern 227, such as a cross-grooved pattern or other knurled surface pattern, which may extend along the length of the body 220, as shown in FIGS. 4 and 5. In some cases, the roughened pattern 227 may be at the first end 221, the second end 223, or an intermediate region 228, or some combination thereof. In other examples, the gripping portion 224 can have another configuration such as, but not limited to, the recesses described above with respect to the tip forming tool 100 .

[0033] A plurality of pins may extend from the first end 221 of the body 220. For example, a first pin 230a, a second pin 230b, and a third pin 230c may be disposed at the first end 221 of the body 220 and extend from the first surface 222 of the body 220. The first pin 230a, the second pin 230b, and the third pin 230c each include a first end region 231a, 231b, 231c, respectively, and a second end region 233a, 233b, 233c, respectively. The second end regions 233a, 233b, 233c may be coupled to the first end 221 of the body 220 of the tip forming tool 200, with the second end regions 233a, 233b, 233c disposed between the first surface 222 of the body 220 and the first end regions 231a, 231b, 231c. The first end regions 231a, 231b, 231c may each include a first outer diameter (e.g., D1 shown in FIG. 7), and the second end regions 233a, 233b, 233c may each include a second outer diameter (e.g., D2 shown in FIG. 7). In some cases, as shown in FIGS. 4, 5, and 7, the first outer diameter D 1は, may be greater than the second outer diameter D2. In some cases, the first outer diameter D 1は It may be the same as the second outer diameter D2.

[0034] As shown in Figures 4-6, the first pin 230a, the second pin 230b, and the third pin 230c may each include a circular cross-section. However, in other examples, one or more of the first pin 230a, the second pin 230b, and / or the third pin 230c may include a different cross-sectional shape. For example, while the first pin 230a, the second pin 230b, and the third pin 230c are shown as including a circular cross-section, it is contemplated that the first pin 230a, the second pin 230b, and the third pin 230c may include a rectangular cross-section, a square cross-section, a triangular cross-section, or some other suitable cross-section. In some cases, the first pin 230a may include a circular cross-section, and the second pin 230b and the third pin 230c may include a cross-sectional shape that is different from the cross-sectional shape of the first pin 230a. In some cases, the side of the second end region 231 a, 231 b, 231 c of one or more of the first pin 130 a, the second pin 130 b, and / or the third pin 130 c may be a convex or arcuate surface. In some cases, it may be envisioned that the first pin 230 a, the second pin 230 b, and the third pin 230 c may each include a different cross-sectional shape from one another. These are merely examples.

[0035] In some cases, the first pin 230a, the second pin 230b, and the third pin 230c may be positioned equidistant from one another. For example, as shown in FIG. 6, the body 220 may include a central rotational axis 225, and the first pin 230a, the second pin 230b, and the third pin 230c may each be positioned equidistant from one another about the central rotational axis 225. Furthermore, the first pin 230a, the second pin 230b, and the third pin 230c may each be positioned equidistant from the central rotational axis 225. In some cases, first pin 230a, second pin 230b, and third pin 230c may not be equidistant from one another and / or one or more of first pin 230a, second pin 230b, and third pin 230c may be positioned farther from central rotation axis 225 than another one of first pin 230a, second pin 230b, and third pin 230c. The distance between each of second end regions 233a, 233b, and 233c of first pin 230a, second pin 230b, and third pin 230c, respectively, may include a distance configured to accommodate a catheter positioned therebetween, as shown in FIG. The pins 230a, 230b, 230c may be positioned such that the distance between each of the second end regions 233a of the first pin 230a, the second end region 233b of the second pin 230b, and the second end region 233c of the third pin 230c may be slightly greater than the outer diameter of the associated catheter. For example, in some cases, the catheter may be a microcatheter, and the distance between each of the second end regions 233a, 233b, 233c may comprise a distance of about 0.025 inches (about 0.635 mm) to about 0.045 inches (about 1.143 mm). In some cases, the distance between each of the second end regions 233a, 233b, 233c may comprise a distance of about 0.04 inches (about 1.016 mm) to about 0.06 inches (about 1.524 mm). In some cases, the distance between each of the second end regions 233a, 233b, 233c may be about 0.03 inches (about 0.762 mm). These are just examples.

[0036] 8A-8B, in use, when the distal end region of the catheter is disposed within gap 234, first pin 230a may be disposed on a first side of the distal end region of the catheter, and second pin 230b and third pin 230c may be disposed on an opposite, second side of the distal end region of the catheter. Once the catheter is disposed within gap 234, body 220 of tip shaping tool 200 may be configured to be manipulated, such as rotated about central rotation axis 225, to generate a curvature in the distal end region of the catheter. In some cases, tip shaping tool 200 may be rotated in a clockwise position. In some cases, tip shaping tool 200 may be rotated in a counterclockwise position.

[0037] FIG. 7 is an enlarged view of the first end 221 of the tip shaping tool 200, as shown in FIG. 5, including the catheter 320. As shown in FIG. 7, the catheter 320 is positioned within a gap 234 between a first pin 230a (located on a first side of the distal end region of the catheter 320) and second and third pins 230b, 230c (located on opposite, second sides of the distal end region of the catheter 320). The third pin 230c is not shown in the side view of FIG. 7. As can be seen, the first pin 230a, the second pin 230b (and, although not explicitly shown, the third pin 230c) include a step, and the first end regions 231a, 231b, 231c have a first outer diameter D1 that is larger than the second outer diameter D2 of the second end regions 233a, 233b, 233c. In some instances, the first outer diameter D 1は The second outer diameter D may range from about 0.05 cm to about 1.0 cm. 2はThe gap 236 between the first end regions 231a, 231b, and 231c may be smaller than the outer diameter of the distal end region of the catheter 320, while the gap 234 between the second end regions 233a, 233b, and 233c may be larger than the outer diameter of the distal end region of the catheter 320. Thus, the gap 234 between the second end regions 233a, 233b, and 233c may be larger than the gap 236 between the first end regions 231a, 231b, and 231c. In some cases, the second end regions 233a, 233b, and 233c may have a length L1, which may be larger than the outer diameter of the distal end region of the catheter 320. In such cases, the distal end region of catheter 320 may fit within gap 234 between second end regions 233a, 233b, 233c, but may not fit within gap 236 between first end regions 231a, 231b, 231c. Thus, first end regions 231a, 231b, 231c may function to hold the distal end region of catheter 320 within gap 234 between second end regions 233a, 233b, 233c while a user shapes the tip of catheter 320 with tip shaping tool 200. In some cases, length L 1は , may be in the range of about 0.03 inches (about 0.762 mm) to about 0.05 inches (about 1.270 mm) or more, or in the range of about 0.05 inches (about 1.270 mm) to about 0.07 inches (about 1.778 mm) or more. This is merely an example. Thus, the distal end region of catheter 320 may be advanced into gap 234 between second end region 233 a of first pin 230 a and second end regions 233 b, 233 c of second and third pins 230 b, 230 c in a direction substantially perpendicular to rotation axis 225, while first end regions 231 a, 231 b, 231 c of first, second, and third pins 230 a, 230 b, 230 c prevent the distal end region of catheter 320 from being removed from gap 234 in a direction substantially parallel to rotation axis 225.

[0038] 8A-8B illustrate an exemplary method of using the tip shaping tool 100 with a catheter 320. While this method is described using the tip shaping tool 100, it should be noted that the tip shaping tool 200 may be used to shape the distal end region of the catheter 320 in a similar manner. This method may include a user grasping the tip shaping tool 100 by its grip portion 124 and inserting the distal end region 321 of the catheter 320 into a gap 134 between the first pin 130a, the second pin 130b, and the third pin 130c of the tip shaping tool 100. In some instances, the user may insert the distal end region 321 through the gap 134 such that the distal-most tip 322 of the distal end region 321 extends beyond the periphery 116 of the first end 121 of the body 120 of the tip shaping tool 100 according to a desired throw length. For example, in some cases, the distal end region 321 may be inserted such that the distal-most tip 322 of the distal end region 321 extends beyond the peripheral edge 116, e.g., by about 0.1 centimeter to about 0.5 centimeter. In some cases, the distal end region 321 of the catheter 320 may include a marker band 324. If the catheter 320 includes a marker band 324, the distal end region 321 of the catheter 320 may be inserted into the tip shaping tool 100 such that an edge (e.g., a proximal end or a distal end) of the marker band 324 is aligned with the peripheral edge 116 of the first end 121 of the tip shaping tool 100 before rotating the body 120 of the tip shaping tool 310.

[0039] In some cases, the first pin 130a may be located on a first side 323 of the distal end region 321 of the catheter 320, while the second pin 130b and the third pin 130c are both disposed on the opposite, second side 325 of the distal end region 321 of the catheter 320. Although the first pin 130a is shown as being located on the first side 323 of the distal end region 321 and the second pin 130b and the third pin 130c are shown as being located on the second side 325 of the distal end region 321, it can be envisioned that the second pin 130b can be located on the first side 323 of the distal end region 321 and the first pin 130a and the third pin 130c can be located on the second side 325 of the distal end region 321. It is also envisioned that the third pin 130c may be located on a first side 323 of the distal end region 321, and the second pin 130b and the first pin 130a may be located on a second side 325 of the distal end region 321. In other words, one of the first, second, and third pins 130a, 130b, 130c may be disposed on the first side 323 of the distal end region 321 of the catheter 320, while the other two of the first, second, and third pins 130a, 130b, 130c may be disposed on the second side of the distal end region 321 of the catheter 320.

[0040] With the distal end region 321 disposed within the gap 134, the tip shaping tool 100 can be rotated about the central rotational axis 125 (shown in FIG. 3 ) such that the distal end region 321 of the catheter 320 moves from a first straight configuration 350 (shown in FIG. 8A ) to a second curved configuration 355 (shown in FIG. 8B ). In some cases, when the catheter 320 moves from the first straight configuration 350 to the second curved configuration 355, the first pin 130 a can be considered to be located on the concave side (e.g., first side 323) of the distal end region 321, and both the second pin 130 b and the third pin 130 c can be considered to be located on the convex side (e.g., second side 325) of the distal end region 321. As described above, if the distal end region 321 is inserted between the pins 130a, 130b, and 130c in different orientations, it is conceivable that the second pin 130b may be located on the concave side of the distal end region 321 and the first pin 130a and the third pin 130c may be located on the convex side of the distal end region 321, or that the third pin 130c may be located on the concave side of the distal end region 321 and the second pin 130b and the first pin 130a may be located on the convex side of the distal end region 321. Although the tip shaping tool 100 is illustrated as being rotated in a counterclockwise direction, as indicated by arrow 340, it is conceivable that the tip shaping tool 100 may be rotated in a clockwise direction. The tip shaping tool 100 may be rotated to generate a curvature in the distal end region 321 of the catheter 320 at any angle desired for navigating through various lumens within the body. For example, in some instances, the tip shaping tool 100 may be rotated to create a 45° (degree) angle, a 55° angle, a 60° angle, a 90° angle, or any other suitable angle at the distal end region 321. The angle may provide a bend between the distal end region 321 and the proximal portion 326 of the catheter 320 proximal to the bend, such that the distal end region 321 and the proximal portion 326 are no longer parallel. The angle created may be determined by the amount the tip shaping tool 100 is rotated. After the desired angle is created at the distal end region 321, the distal end region 321 of the catheter 320 may be removed from the tip shaping tool 100.

[0041] The above-described method of shaping the distal tip region 321 of the catheter 320 may be performed with the catheter 320 at room temperature in the surgical procedure location (e.g., operating room, emergency room, catheter lab, etc.) without the application of heat from a heat source (e.g., without the application of steam). Additionally, the above-described method of shaping the distal tip region 321 of the catheter 320 may be performed manually by medical personnel during a medical procedure (i.e., during surgery) when the catheter 320 is removed from its packaging. As described below, in some examples, the tip shaping tools 100, 200 may be provided in a package along with the catheter 320. In other examples, the tip shaping tools 100, 200 may be provided separately and accessible during the medical procedure.

[0042] FIG. 9 shows an exemplary graph 400 comparing angle maintenance between distal tip regions of catheters shaped using a tip shaping tool according to the present disclosure and pre-shaped catheters. Sample catheters with tips shaped with a tip shaping tool according to the present disclosure were compared with sample catheters with pre-shaped tips. As described with reference to FIGS. 8A and 8B , the distal tip region of a catheter (e.g., distal tip region 321 of catheter 320) may be formed with the catheter at room temperature in the surgical procedure site without the application of heat from a heating source. The distal tip regions of multiple sample catheters were shaped at room temperature to a nominal angle of approximately 90 degrees using a tip shaping tool according to the present disclosure. As shown in FIG. 9 , the average initial tip angle 410 of the distal tip regions of the sample catheters was approximately 90 degrees + / −2 degrees, as indicated by reference numeral 415. The molded distal tip regions of the sample catheters were then held in a straight configuration (a mandrel was inserted into the lumen to straighten the molded distal tip so that it was parallel to the proximal catheter shaft) and immersed in a 37°C water bath for 30 minutes. The sample catheters were then removed from the water bath, and the angle of the distal tip regions was measured again after the mandrel was removed. As shown, the distal tip regions of the sample catheters molded in accordance with the present disclosure had a final angle 420, indicated by the numeral 425, of about 76 degrees + / - 2 degrees, maintaining about 84% of the initial angle 410. Thus, the distal tip regions of catheters molded in accordance with the present disclosure have distal tip angle retention of 60% or more, 70% or more, or 80% or more of their initial molded angle.

[0043] For comparison, the initial angle of the preformed catheter samples was measured. The average initial angle 430 of the preformed distal tip regions of the preformed catheter samples, as indicated by reference numeral 435, was approximately 82 degrees + / - 2 degrees. The preformed catheter samples were subjected to the same test: the preformed distal tip regions of the preformed catheter samples were held in a straight configuration (a mandrel was inserted into the lumen to straighten the preformed distal tip so that it was parallel to the proximal catheter shaft) and immersed in a 37°C water bath for 30 minutes. The preformed-tip sample catheters were then removed from the water bath, and the angle of the distal tip region was measured again after the mandrel was removed. The preformed distal tip region catheter samples had an average final angle 440 of approximately 54 degrees + / - 2 degrees, as indicated by reference numeral 445, thus maintaining approximately 65% ​​of the initial angle 430.

[0044] Thus, distal tip regions shaped with a tip shaping tool according to the present disclosure have better retention angles than catheters with pre-shaped distal tip regions, as shown in graph 400. Retention of the distal tip region allows a user (e.g., a physician) to maintain access and / or more easily navigate through tortuous blood vessels throughout a medical procedure.

[0045] 10 is a partial view showing an elongate shaft 500, an outer layer 510, a middle layer 520, and an inner layer 530 of a catheter 320 according to an embodiment of the present disclosure. The inner layer 530 may define a lumen 535 extending therethrough. The lumen 535 may be considered a guidewire lumen, an infusion lumen, or the like. By way of example, in use, a practitioner may insert the catheter 320 over a guidewire (not shown). Once the target blood vessel is reached, the practitioner may remove the guidewire and infuse fluid into the target site through the lumen 535.

[0046] The elongate shaft 500 inner layer 530 may be formed from or include a coating of a material having a suitably low coefficient of friction. An example of a suitable material may include polytetrafluoroethylene (PTFE). The inner layer 530 may be sized to define a lumen 535 having an inner diameter suitable to accommodate the intended use. In some cases, the inner layer 530 may define a lumen 535 having a diameter of about 0.021 inches (about 0.533 mm) to about 0.027 inches (about 0.686 mm).

[0047] The outer layer 510 may be formed from a polymer that may provide the desired flexibility and strength. In some cases, the outer layer 510 may be formed from a nylon polymer, a thermoplastic polymer, an elastomeric polyamide, or some other suitable polymer. The outer layer 510 may be sized to define the outer diameter of the elongate shaft 500. In some cases, the outer diameter of the elongate shaft 500 may be less than 3 French. In some cases, the outer layer 510 may have an OD of 1.7 French or less, 2 French or less, 2.5 French or less, 2.8 French or less, or some other suitable outer diameter.

[0048] The intermediate layer 520 may be disposed between the outer layer 510 and the inner layer 530 and may be formed of a reinforcing structure such as a braid or coil. The intermediate layer 520 may be considered a reinforcing layer that increases the torque response of the elongate shaft 500. The intermediate layer 520 may be formed of any suitable material, such as stainless steel, tungsten, gold, titanium, silver, copper, platinum, or nitinol. In some cases, the intermediate layer 520 may be formed of a non-metallic material, such as a polymer fiber, glass fiber, or liquid crystal polymer (LCP) fiber. When provided as a braided reinforcing layer, the intermediate layer 520 may be formed using a variety of different weave patterns, such as a three-over-three weave, a four-over-four weave, or the like. In some cases, the intermediate layer 520 may be formed using a two-over-two weave configuration, as further described with reference to FIG. 11 .

[0049] FIG. 11 is a partial view of a braid 550 of the elongate shaft 500. As previously discussed and with reference to FIG. 9, the braid 550 may form an intermediate layer (e.g., intermediate layer 520) of the elongate shaft 500. The braid 550 may be formed from multiple strands 552, and each strand may be formed from multiple filaments 554. The braid 550 may include 12 to 20 strands 552. In some cases, the braid 550 may include 16 strands 552. The braid 550 pattern may range from about 100 to about 140 picks per inch (PPI). In some cases, the braid 550 pattern may be in the range of about 120 PPI. In some embodiments, the braid 550 may achieve at least 70 percent coverage of the surface area of ​​the exterior surface of the inner layer 530, thereby providing the elongate shaft 500 with high burst pressure capabilities. In some cases, braid 550 may achieve at least 60 percent coverage, 80 percent coverage, 90 percent coverage, or some other suitable coverage of the surface area of ​​the outer surface of inner layer 530.

[0050] In some cases, as shown in FIG. 11 , each of the plurality of strands 552 may include four filaments 554. The filaments 554 may be formed of any suitable material, such as stainless steel, tungsten, gold, titanium, silver, copper, platinum, or nitinol. In some cases, at least one strand 552 may include at least one stainless steel filament 554 and at least one tungsten filament 554. In other cases, at least one strand 552 may include two stainless steel filaments 554 and two tungsten filaments 554. In other cases, at least one strand 552 may be formed from four stainless steel filaments 554, and a second strand 552 may be formed from four tungsten filaments 554. Each strand 552 may be formed from any suitable combination of filaments 554, as desired. Some example strands may have five or more filaments. Other examples may have strands consisting of exactly four filaments.

[0051] In some instances, each strand 552 is formed from four filaments 554 arranged side-by-side and braided in a two-over-two-under weave configuration. A four-filament 554 braid 550 in an over-two-under-two configuration may provide greater torque response to the elongate shaft 500 and may allow for greater pushability, thereby reducing the number of kinks that may occur within the elongate shaft 500. The structure of the braid 550 may provide desired radial strength to prevent the lumen 535 from collapsing during a catheter tip shaping process, such as the methods disclosed herein. Additionally, the structure of the braid 550 may provide sufficient flexibility to allow the catheter tip to maintain its desired shape (e.g., any curves that occur) during the catheter tip shaping process.

[0052] The filaments 554 may, in some examples, have a circular cross-sectional shape. Alternatively, the filaments 554 may include a flattened, rectangular, oval, or any other suitable cross-sectional shape. The filaments 554 may each include an outer diameter of less than 0.0009 inches (about 0.023 mm). In some cases, each filament 554 may include an outer diameter of 0.00085 inches (about 0.022 mm) or less, 0.0008 inches (about 0.020 mm) or less, 0.00075 inches (about 0.019 mm) or less, 0.0006 inches (about 0.015 mm) or less, or some other suitable diameter. Filaments 554 may have an outer diameter, for example, in the range of about 0.0006 inches (about 0.015 mm) to about 0.0009 inches (about 0.023 mm), or in the range of about 0.00075 inches (about 0.019 mm) to about 0.00085 inches (about 0.022 mm). Each filament 554 may be the same size and shape, or filaments 554 may be of different sizes and shapes. For example, strand 552 may include two larger tungsten filaments 554 and two smaller stainless steel filaments 554.

[0053] In some cases, the distal end of the elongate shaft 500 of the catheter 320 may be provided with a distal tip (shown in FIG. 12 ). The distal tip may be a polymeric distal tip, which may be formed from an elastomer (e.g., Pebax®), a thermoplastic polymer, or any other suitable polymer. The distal tip may be formed from a softer material than the rest of the elongate shaft 500 of the catheter 320, such as by using a polymer or elastomer with a Shore hardness of less than 63D. In some cases, the distal tip may be formed from a polymer with a Shore hardness of about 40D or 35D. In some cases, the distal tip may have a length of about 1 millimeter (mm). In other cases, the distal tip may have a length of about 1.5 mm, about 1.3 mm, about 1.7 mm, or some other suitable length.

[0054] The elongate shaft of the catheter 320 may be adapted to provide improved torque response, i.e., such that a particular rotation made at the proximal end region is transmitted to the distal end region 321. In some cases, the elongate shaft may be adapted to provide sufficient torque response such that a particular rotation made at the proximal end region provides a torque response at the distal end region 321 of at least 0.9:1 (e.g., 90 percent). As an example, a 90-degree rotation made at the proximal end region will correlate with approximately 81 degrees of rotation made at the distal end region 321. In some cases, the elongate shaft may provide a torque response of at least 0.95:1 (e.g., 95 percent). As an example, a 90-degree rotation made at the proximal end region will correlate with approximately 85.5 degrees of rotation made at the distal end region 321. In other cases, the elongate shaft may provide a torque response at the distal end region 321 of at least 0.98:1 (e.g., 98 percent). As an example, a 360° rotation made in the proximal end region would correlate to approximately 356° rotation made in the distal end region 321. These are merely examples.

[0055] FIG. 12 illustrates a kit 600 including a catheter 320 and a tip shaping tool 100, where the catheter 320 and the tip shaping tool 100 are provided in packaging 610. As shown in FIG. 12, the catheter 320 may include an elongate shaft 500 having a distal end region 321 extending to a distal-most tip 322. The catheter 320 may include a hub 330 secured to the proximal end of the elongate shaft 500. The catheter 320 may have any desired length and outer diameter. For example, the catheter 320 may have a length ranging from approximately 50 to 200 centimeters and may have an outer diameter (OD) of, for example, less than 3 French. In some cases, the catheter 320 may have an OD of 1.7 French or less, 2 French or less, 2.5 French or less, 2.8 French or less, or some other suitable outer diameter. In some cases, the catheter 320 may include an OD of about 2.6 French along the distal end region 321 and an OD of about 2.8 French along the proximal end region 322. In some cases, the catheter 320 may have an inner diameter (ID) of, for example, about 0.021 inches (about 0.533 mm) to 0.027 inches (about 0.686 mm). In other cases, the catheter 610 may have an ID of about 0.02 inches (about 0.508 mm), 0.03 inches (about 0.762 mm), or some other suitable inner diameter. These sizes may vary depending on the particular use.

[0056] While the catheter 320 is shown packaged with the tip shaping tool 100, in other examples, the catheter 320 may be packaged in the package 610 with the tip shaping tool 200 or another tip shaping tool having the features and functionality as disclosed herein. Thus, upon opening the package 610 to access the catheter 320, medical personnel may also be provided with the tip shaping tool 100, 200 for manually shaping the distal end region of the catheter 320 into a desired curvature or shape during surgery. These are merely examples. The tip shaping tools 100, 200, the catheter 320, and various components thereof may be manufactured according to essentially any suitable manufacturing technique, including coextrusion, molding, casting, 3D printing, machining, etc., as well as any other suitable technique. Furthermore, the various structures may include materials commonly associated with medical devices, such as metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, etc., or other suitable materials. These materials may include transparent or translucent materials to aid in visualization during the procedure. Some examples of suitable metals and metal alloys include stainless steels such as 304V, 304L, and 316LV stainless steels, mild steel, nickel-based alloys, or any other suitable material.

[0057] Some examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block esters, polyurethanes (e.g., Polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyetheresters (e.g., ARNITEL® available from DSM Engineering Plastics), ether or ester-based copolymers (e.g., butylene / poly(alkylene ether) phthalates and / or other polyester elastomers such as HYTREL® available from DuPont), polyamides (e.g., DURETHAN® or Elf® available from Bayer), and the like. CRISTAMID® available from Atochem), elastomeric polyamides, block polyamide / ethers, polyether block amides (PEBA, e.g., available under the trade name PEBAX®), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), MARLEX® high density polyethylene, MARLEX® low density polyethylene, linear low density polyethylene (e.g., REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (EMS American GRILAMID® available from Grillon, etc.), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxies, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS50A), polycarbonate, ionomer, biocompatible polymer, other suitable material, or mixtures, combinations, copolymers, polymer / metal composites, etc. In some embodiments, the sheath may be blended with a liquid crystal polymer (LCP). For example, the mixture may contain up to about 6% LCP.

[0058] In at least some embodiments, the catheter 320 may also be doped with, made of, or otherwise include a radiopaque material. A radiopaque material is understood to be a material that can produce a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image assists the user of the catheter 320 in determining the location of the catheter. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials loaded with radiopaque fillers, and the like. Additionally, other radiopaque marker bands and / or coils may also be incorporated into the design of the catheter 320 to achieve the same results.

[0059] It will be understood that this disclosure is, in many respects, merely illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps, without exceeding the scope of the disclosure. This may include, to the extent appropriate, using any of the features of one example embodiment in other embodiments. The scope of the disclosure is, of course, defined in the language in which the appended claims are expressed.

Claims

1. 1. A catheter tip shaping system comprising: a catheter; a tip shaping tool, the tip shaping tool comprising: a body having a first end and a second end; a first pin, a second pin, and a third pin, the first pin, the second pin, and the third pin being disposed at the first end of the body and extending from a first surface of the body; the distal end region of the catheter is configured to be positioned between one gap between the first, second, and third pins so that the tip shaping tool can be manipulated by a user to generate a curvature in the distal end region of the catheter; Catheter tip shaping system.

2. The catheter tip shaping system of claim 1 , wherein the first, second, and third pins are positioned equidistant from one another.

3. 3. The catheter tip shaping system of claim 1, wherein the distance between each of the first, second, and third pins is between about 0.635 mm and about 1.143 mm.

4. The catheter tip shaping system according to any one of claims 1 to 3, wherein the body includes a grip portion that is gripped by the user.

5. The catheter tip shaping system of any one of claims 1 to 4, wherein the first, second, and third pins each comprise a circular cross-section.

6. 6. The catheter tip shaping system of claim 1, wherein the first, second, and third pins each include a first end region and a second end region, the first end region including a first outer diameter, and the second end region including a second outer diameter, the first outer diameter being larger than the second outer diameter.

7. 7. The catheter tip shaping system of claim 6, wherein the second end regions of the first, second, and third pins are coupled to the first end of the body of the tip shaping tool with the second end regions of the first, second, and third pins disposed between the first surface of the body and the first end regions of the first, second, and third pins.

8. 8. The catheter tip shaping system of claim 7, wherein a gap between the first end regions of the first, second, and third pins is smaller than an outer diameter of the distal end region of the catheter, and a gap between the second end regions of the first, second, and third pins is larger than an outer diameter of the distal end region of the catheter.

9. 9. The catheter tip shaping system of claim 8, wherein when the distal end region of the catheter is positioned within the gap, the first pin is positioned on a first side of the distal end region of the catheter and the second and third pins are positioned on a second, opposite side of the distal end region of the catheter.

10. 1. A method of shaping a distal end of a catheter using a tip shaping tool, the method comprising: inserting the distal end region of the catheter into gaps between first, second, and third pins of the tip shaping tool, the tip shaping tool comprising: a body having a first end and a second end, the first pin, the second pin, and the third pin being disposed at the first end of the body and extending from a first surface of the body; rotating the tip shaping tool to move the distal end region of the catheter from a first straight configuration to a second curved configuration; removing the distal end region of the catheter from the tipping tool; the tip shaping tool is rotatable in a clockwise or counterclockwise direction, or in a clockwise and counterclockwise direction; method.

11. 11. The method of claim 10, wherein when the distal end of the catheter is inserted into the gap of the tip forming tool, the first pin is located on a first side of the distal end region of the catheter and the second and third pins are positioned on a second, opposite side of the distal end region of the catheter.

12. 12. The method of claim 10 or 11, wherein the first pin is located on a concave side of the distal end region of the second curved configuration, and the second and third pins are located on a convex side of the distal end region of the second curved configuration.

13. 13. The method of claim 10, wherein when the distal end region of the catheter is inserted into the tip shaping tool, an end of a marker band disposed on the catheter is aligned with an edge of the first end of the tip shaping tool before rotating the tip shaping tool.

14. 1. A catheter tip forming tool comprising: a body having a first end and a second end; a first pin, a second pin, and a third pin, the first pin, the second pin, and the third pin being disposed at the first end of the body and extending from a first surface of the body; Catheter tip shaping tool.

15. 15. The catheter tip forming tool of claim 14, wherein the first, second, and third pins each include a first end region and a second end region, the first end region being disposed between the first surface of the body and the second end region, and the first end region including an outer diameter that is smaller than an outer diameter of the second end region.

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