Guide wire and medical device comprising laser cutting tube

Abstract

A guidewire device includes an elongated core wire and a tube member on a distal end portion of the elongated core wire. The tubular member includes a plurality of transverse cutouts at a plurality of axial locations of the tubular member to form a plurality of circumferentially extending rings connected by a plurality of beams. The plurality of transverse cutouts includes a tapered geometry, wherein a cutout width at an outer surface of the pipe member is greater than a cutout width at an inner surface of the pipe member.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 610,697, filed on December 15, 2023, entitled “Guidewire and Medical Device including Laser Cut Tube,” and U.S. Patent Application No. 18 / 963,683, filed on November 28, 2024, entitled “Guidewire and Medical Device including Laser Cut Tube,” the entire contents of which are incorporated herein by reference. Technical Field

[0002] The present application generally relates to medical devices and methods of making medical devices and methods of using medical devices to treat diseases. In particular, various embodiments of guidewire devices and methods of making the same are described. Background Art

[0003] Guidewires are widely used in the medical field to guide devices to specific locations in the patient's body to perform delicate procedures, such as guiding a catheter deep into a blood vessel in the body. Guidewires often require a variable stiffness profile, usually with the most flexible section at the distal end, while maintaining good torque transmission for tracking and delivery in tortuous anatomical structures. It is important to ensure that the tip of the guidewire can be bent to a small radius to form a curved shape that facilitates vessel selection.

[0004] A guidewire typically includes a core wire, which may be tapered at its distal end, reinforced with a structure connected to an atraumatic tip. Traditionally, metal coils have been used as guidewire reinforcements. With the development of micromachining technology, micromachined hypotubes have also entered the field as device components. However, due to the size and shape of the cutting element, micromachining technology is limited in terms of processing speed, cutting geometry, and the length that can be imparted to the hypotube.

[0005] Therefore, although progress has been made in the field of guidewire devices, there is still a general need for improvements to overcome these and other problems encountered by conventional techniques. It would be desirable to provide a new technique for achieving cutting geometries on guidewire devices that can balance the complex requirements of bending flexibility, tensile strength and torque transmission for various medical applications and allow the guidewire tip to achieve a smaller bending radius without kinking. Summary of the invention

[0006] On the one hand, embodiments of the present disclosure are based on guide wire devices. Typically, embodiments of guide wire devices include an elongated core wire and a tubular member on the distal end portion of the elongated core wire. The tubular member includes a plurality of transverse cuts at a plurality of axial positions of the tubular member to form a plurality of circumferentially extending rings connected by a plurality of beams. The plurality of transverse cuts include a tapered geometry, wherein the cut width at the outer surface of the tubular member is greater than the cut width at the inner surface of the tubular member.

[0007] In various embodiments of this aspect, the tapered geometry of at least one of the plurality of transverse cuts comprises a taper angle ( X ): X = 2 arcsin [( c / 2) / ( r-b / 2)] in, c represents the cut width of at least one of the plurality of transverse cuts at the inner surface, r represents the inner radius of the tube member, and b The beam height of the beam adjacent to at least one of the plurality of transverse cutouts is represented.

[0008] In various embodiments of this aspect, the tapered geometry of at least one of the plurality of transverse cuts forms chamfered inner surfaces of a pair of circumferentially extending rings adjacent to the at least one of the plurality of transverse cuts, wherein the chamfered inner surfaces meet flush when the tubular member is bent at an angle.

[0009] In various embodiments of this aspect, the tapered geometry of at least one of the plurality of transverse cuts comprises a taper angle ranging from about 8 degrees to about 25 degrees ( X ).

[0010] In various embodiments of this aspect, the kerf width at the inner surface of the tube member is equal to or less than 30 microns. In an embodiment, the kerf width at the inner surface of the tube member is equal to or less than 10 microns. In an embodiment, the kerf width at the inner surface is between 10 microns and 30 microns.

[0011] In various embodiments of this aspect, the kerf width at the outer surface of the tube member is equal to or less than 47 microns. In an embodiment, the kerf width at the outer surface of the tube member is equal to or less than 15 microns. In an embodiment, the kerf width at the outer surface ranges between 15 microns and 47 microns.

[0012] In various embodiments of this aspect, the plurality of transverse cuts extend in a plane that is substantially perpendicular to the longitudinal axis of the tubular member.

[0013] In various embodiments of this aspect, the plurality of transverse cuts comprises a single beam cut pattern.

[0014] In various embodiments of this aspect, the plurality of transverse cuts comprises a double beam cut pattern.

[0015] In various embodiments of this aspect, the plurality of transverse cuts comprises a three-beam cut pattern.

[0016] In various embodiments of this aspect, the tube member comprises a metal tube.

[0017] In various embodiments of this aspect, the tubular member comprises a polymeric tube.

[0018] In various embodiments of this aspect, the guidewire device further comprises a radiopaque coil positioned between the tubular member and the elongated core wire.

[0019] In another aspect, embodiments of the present disclosure feature a method of manufacturing a guidewire device. Generally, embodiments of the method include the following steps: Provides a thin and long core wire; providing a tubular member having an outer surface and an inner surface; forming a plurality of transverse cuts in the tube member at a plurality of axial locations of the tube member to produce a plurality of circumferentially extending rings connected by a plurality of beams, wherein the plurality of transverse cuts are formed by using a laser to remove more material at the outer surface of the tube member than at the inner surface to form the plurality of transverse cuts having a tapered geometry wherein a cut width at the outer surface is greater than a cut width at the inner surface; and The tubular member is coupled to a distal portion of the elongated core wire.

[0020] In various embodiments of this aspect, the tapered geometry of at least one of the plurality of transverse cuts comprises a taper angle ( X ): X = 2 arcsin [( c / 2) / ( r-b / 2)] in, c represents the cut width of the at least one transverse cut of the plurality of transverse cuts at the inner surface, r represents the inner radius of the tube member, and b The beam height of the beam adjacent to the at least one transverse cutout among the plurality of transverse cutouts is represented.

[0021] In various embodiments of this aspect, the tapered geometry of at least one of the plurality of transverse cuts comprises a taper angle ranging from about 8 degrees to about 25 degrees. （X） . In various embodiments of this aspect, the laser is configured to provide beam pulses having a focal angle equal to a cone angle of at least one of the plurality of transverse cuts, or within 5 degrees greater or less than a cone angle of at least one of the plurality of transverse cuts.

[0022] In various embodiments of this aspect, the kerf width at the inner surface of the tube member is equal to or less than 30 microns. In an embodiment, the kerf width at the inner surface of the tube member is equal to or less than 10 microns. In an embodiment, the kerf width at the inner surface is between 10 microns and 30 microns.

[0023] In various embodiments of this aspect, the kerf width at the outer surface of the tube member is equal to or less than 47 microns.

[0024] In various embodiments of this aspect, the kerf width at the outer surface of the tube member is equal to or less than 22 microns. In an embodiment, the kerf width at the outer surface is between 15 microns and 47 microns. In an embodiment, the kerf width at the outer surface is between 15 microns and 25 microns. In an embodiment, the kerf width at the outer surface of a portion of the tube member is between 23 microns and 47 microns.

[0025] In another aspect, embodiments of the disclosure feature a tubular member for a medical device. In general, embodiments of the tubular member include a plurality of transverse cuts at a plurality of axial locations of the tubular member to form a plurality of circumferentially extending rings connected by a plurality of beams, wherein the plurality of transverse cuts include a tapered geometry, and the width of the cuts at the outer surface of the tubular member is greater than the width of the cuts at the inner surface of the tubular member.

[0026] In various embodiments of this aspect, the tapered geometry of at least one of the plurality of transverse cuts comprises a taper angle ( X ): X = 2 arcsin [( c / 2) / ( r-b / 2)] in, c represents the cut width of at least one of the plurality of transverse cuts at the inner surface, r represents the inner radius of the tube member, andb The beam height of the beam adjacent to the at least one transverse cutout among the plurality of transverse cutouts is represented.

[0027] In various embodiments of this aspect, the tapered geometry of at least one of the plurality of transverse cuts forms chamfered inner surfaces of a pair of circumferentially extending rings adjacent to the at least one of the plurality of transverse cuts, wherein the chamfered inner surfaces meet flush when the tubular member is bent at an angle.

[0028] In various embodiments of this aspect, the tapered geometry of at least one of the plurality of transverse cuts comprises a taper angle ranging from about 8 degrees to about 25 degrees ( X ).

[0029] In various embodiments of this aspect, the kerf width at the inner surface of the tube member is equal to or less than 30 microns. In an embodiment, the kerf width at the inner surface of the tube member is equal to or less than 10 microns. In an embodiment, the kerf width at the inner surface is between 10 microns and 30 microns.

[0030] In various embodiments of this aspect, the kerf width at the outer surface of the tube member is equal to or less than 47 microns. In an embodiment, the kerf width at the outer surface of the tube member is equal to or less than 22 microns. In an embodiment, the kerf width at the outer surface is between 15 microns and 47 microns. In an embodiment, the kerf width at the outer surface is between 15 microns and 25 microns. In an embodiment, the kerf width at the outer surface of a portion of the tube member is between 23 microns and 47 microns.

[0031] In various embodiments of this aspect, the plurality of transverse cuts extend in a plane that is substantially perpendicular to the longitudinal axis of the tubular member.

[0032] In various embodiments of this aspect, the plurality of transverse cuts comprises a single beam cut pattern.

[0033] In various embodiments of this aspect, the plurality of transverse cuts comprises a double beam cut pattern.

[0034] In various embodiments of this aspect, the plurality of transverse cuts comprises a three-beam cut pattern.

[0035] In various embodiments of this aspect, the tube member comprises a metal tube.

[0036] In various embodiments of this aspect, the tubular member comprises a polymeric tube.

[0037] The present disclosure is provided to introduce selected aspects and embodiments of the present disclosure in a simplified form, and is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to help determine the scope of the claimed subject matter. The selected aspects and embodiments are presented only to provide the reader with some forms of the present disclosure that the present invention may take, rather than to limit the scope of the present invention. Other aspects and embodiments of the present disclosure are described in the detailed description section.

[0038] These and various other aspects, embodiments, features and advantages of the present disclosure will be better understood from the following detailed description read in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Figure 1 is a simplified illustration of an example guidewire device according to an embodiment of the present disclosure.

[0040] Figure 2 is a simplified illustration of an example tubular member that may be used as a guidewire device assembly according to an embodiment of the present disclosure.

[0041] Figure 3 is a cross-sectional side view of an example tube member including a plurality of tapered cuts according to an embodiment of the present disclosure.

[0042] Figure 4 The bending radius of a conventional pipe member including a plurality of vertical cutouts was compared with a pipe member including a plurality of tapered cutouts according to an embodiment of the present disclosure.

[0043] Figure 5 Example tapered cutout geometries are shown in accordance with embodiments of the present disclosure.

[0044] Figure 6 is a simplified illustration of a tube member including multiple cutouts in a single beam cutout pattern according to an embodiment of the present disclosure.

[0045] Figure 7 is a simplified illustration of a tube member including multiple cutouts in a dual beam cutout pattern according to an embodiment of the present disclosure.

[0046] Figure 8 is a simplified illustration of a tube member including multiple cutouts in a triple beam cutout pattern according to an embodiment of the present disclosure.

[0047] Fig. 9 is a flow chart illustrating example steps of a method of manufacturing a guidewire device according to an embodiment of the present disclosure.

[0048] Fig. 10A is a simplified illustration showing a side view of a tapered cutout in a tube member according to an embodiment of the present disclosure. Fig. 10B Schematically shows Fig. 10AThe bending of the pipe components during use.

[0049] Fig.11A is a simplified illustration showing a side view of a vertical cut in a tube member for comparison. Fig. 11B Schematically shows Fig.11A The bending of the pipe components during use.

[0050] Fig.12 is a simplified illustration showing some parameters of a cutout in a tube component.

[0051] Fig.13 An example laser beam is shown deposited on a tube member to form a tapered cut according to an embodiment of the present disclosure.

[0052] Fig.14 is a simplified illustration of a tube component showing some details of the tapered cut geometry according to an embodiment of the present disclosure. DETAILED DESCRIPTION

[0053] With reference to the accompanying drawings, various embodiments of guidewire devices and methods of manufacturing guidewire devices will now be described. The accompanying drawings are intended to facilitate the description of embodiments of the present disclosure and are not necessarily drawn to scale. Certain specific details may be listed in the accompanying drawings to provide a comprehensive understanding of the present disclosure. It will be clear to those of ordinary skill in the art that some of these specific details may not be used to implement embodiments of the present disclosure. In other cases, structures, components, systems, materials and / or operations that are typically associated with known medical procedures may not be shown or described in detail to avoid unnecessarily obscuring the description of embodiments of the present disclosure.

[0054] Embodiments of the present disclosure provide a guidewire device including a tubular member coupled to a distal portion of an elongated core wire for strengthening and improving performance. The tubular member includes a plurality of transverse cuts, the pattern and / or geometry of the cuts providing the guidewire device with an ideal balance between bending flexibility, torsional stiffness, and tensile strength, while also enabling the distal portion of the guidewire device to achieve a smaller bending radius without kinking. Embodiments of the present disclosure also provide a method for manufacturing a guidewire device using a laser to achieve new cutting geometries and processing speeds that are not achievable with conventional techniques.

[0055] Figure 1An example guidewire device 100 according to an embodiment of the present disclosure is shown. The guidewire device 100 is generally configured to be used in conjunction with a medical device to perform a medical procedure. An example application of the guidewire device 100 of the present disclosure is for guiding a catheter deep within a neurovascular vessel. In summary, the guidewire device 100 includes an elongated core wire 102 and a tubular member 200 coupled to the core wire 102. The elongated core wire 102 extends between a proximal portion 104 and a distal portion 106 and has a length suitable for a particular application. The distal portion 106 of the core wire 102 may taper toward the distal end to provide greater bending flexibility. The proximal portion 104 of the core wire 102 may have an increased diameter to maintain the pushability and torsional rigidity of the guidewire device 100. The tubular member 200 is disposed on the distal portion 106 of the core wire 102. The tubular member 200 may be bonded to the distal portion 106 of the core wire 102 at one or more attachment points using, for example, adhesives, welding, soldering, etc., to allow torque to be transferred from the proximal portion 104 of the core wire 102 to the tubular member 200 and / or from the tubular member 200 to the distal portion 106 of the core wire 102. In the space between the tubular member 200 and the distal portion 106 of the core wire 102, a radiopaque material 108 such as platinum, gold or other heavy metals, in the form of a coil wrapped around and / or adhered to the core wire 102, may be provided for fluoroscopic imaging. An atraumatic tip 110, such as a rounded shape, may be formed at the distal end of the guidewire device 100 to prevent damage to the blood vessel. According to an embodiment of the present disclosure, the tubular member 200 includes a plurality of cutouts 210 configured to improve the effectiveness of the guidewire device 100, for example, to achieve a desired balance between bending flexibility, torsional stiffness, and tensile strength, as will be described in more detail below.

[0056] refer to Figure 2, shows an example tube member 200 including a plurality of cuts or grooves 210. The tube member 200 includes an outer surface 202, an inner surface 204, and a thickness between the outer surface 202 and the inner surface 204. A plurality of transverse cuts 210 are formed at a plurality of axial positions of the tube member 200 to form a plurality of circumferentially extending rings 212 connected by a plurality of beams or axially extending beams 214. For ease of describing the various embodiments of the present disclosure, the term "axial position" is used to refer to a position along the longitudinal axis 201 of the tube member 200. The term "transverse cut" 210 refers to a cut or groove in the tube member 200 extending in a plane transverse to the longitudinal axis 201 of the tube member 200. The transverse cut 210 can be formed in a plane substantially perpendicular to the longitudinal axis 201 of the tube member 200. The transverse cut 210 can also be formed at an angle of, for example, 5 to 45 degrees relative to a plane perpendicular to the longitudinal axis 201 of the tube member 200. The term "cut width" may be used to refer to the width of the tube material removed or the width of the gap created by cutting. The term "circumferentially extending ring" 212 refers to an uncut annular structure in the tube member 200 that extends circumferentially around the longitudinal axis 201 of the tube member 200. The term "beam" 214 refers to the uncut portion of the tube member 200 that connects adjacent circumferentially extending rings 212. The term "axially extending beam" may be used interchangeably with the term "beam" because the beam extends along the longitudinal axis 201 of the tube member 200 when connecting adjacent circumferentially extending rings. The term "beam height" may be used to refer to the dimension of the beam that separates two adjacent transverse cuts in a plane.

[0057] refer to Figure 3 and Figure 5 According to an embodiment of the present disclosure, a tube member 200 is provided with a plurality of transverse cuts 210 with a tapered geometry at a plurality of axial positions of the tube member 200. The transverse cuts 210 with a tapered geometry have a first cut width (CW1) at the outer surface 202 of the tube member and a second cut width (CW2) at the inner surface 204 of the tube member 200, wherein the first cut width (CW1) is greater than the second cut width (CW2), i.e., more tube material is removed from the outer surface 202 of the tube member 200 than from the inner surface 204. The plurality of transverse cuts 210 with a tapered geometry in the tube member 200 produces a plurality of circumferentially extending rings 212 with a tapered geometry in the cross section of the ring. The plurality of circumferentially extending rings 212 having a tapered geometry have a first ring width ( RW1 ) at the outer surface 202 of the tubular member 200 and a second ring width ( RW2 ) at the inner surface 204 of the tubular member 200 , wherein the first ring width ( RW1 ) is less than the second ring width ( RW2 ).

[0058] refer to Figure 3In an embodiment, a plurality of transverse cuts 210 having a tapered geometry are formed at the same side of the tubular member 200, thereby forming a plurality of circumferentially extending rings 212 at the same side. This arrangement allows the tubular member 200 to be bent in a preferred orientation and / or a smaller bending radius, such as Figure 4 shown.

[0059] Figure 4 The bending radius of the tube member 200 of the present disclosure (left figure) and the conventional tube member 200' (right figure) are compared, both of which have the same tube thickness. The tube member 200 of the present disclosure is provided with a plurality of cutouts having a tapered geometry, while the conventional tube member 200' is provided with a plurality of cutouts having a perpendicular geometry. When the tube member 200 of the present disclosure is bent in a direction toward, for example, the side where the cutouts 210 are provided, the circumferentially extending rings 212 will be close together on the outer surface 202 side of the tube member 200 and separate on the inner surface 204 side of the tube member 200. Similarly, when the conventional tube member 200' is bent in a direction toward the side where the cutouts are provided, the circumferentially extending rings 212' will be close together on the outer surface side of the tube member 200' and separate on the inner surface side of the tube member 200'. If the tube member 200, 200' is bent sufficiently, the rings 212, 212' will collide on the outer surface side to prevent the tube member 200, 200' from any further bending without kinking. A conventional tube member 200' provided with a plurality of vertical cuts 212' allows bending at a radius of R1. For the tapered cuts 210 according to the present disclosure that remove more material from the outer surface 202 of the tube member 200, adjacent rings 212 have a larger gap at the outer surface 202 of the tube member 200, thus allowing the tube member 200 to bend further before the rings 212 collide with the outer surface 202 of the tube member 200, thereby allowing the tube member 200 to bend at a tighter or smaller radius R2.

[0060] refer to Figure 5 , according to an embodiment of the present disclosure, an exemplary tapered geometry of the transverse cutout 210 and / or the circumferentially extending ring 212 is shown. The non-parallel sides or legs of the trapezoidal geometry of the adjacent circumferentially extending ring 212 form a tapered angle ( X Before the ring 212 collides with the outer surface 202 of the tube member 200, a larger cone angle ( X ) will provide a larger bending clearance for the circumferentially extending ring 212. According to an embodiment of the present disclosure, the taper angle ( X ) can be in the range of 8 degrees to 25 degrees. Selecting an appropriate cone angle ( X ) include the diameter and thickness of the tube member 200, and the desired bending radius (R) of the tube member 200. According to an embodiment of the present disclosure, the taper angle ( X) to allow the tube member 200 to bend at least 180 degrees, or 270 degrees, or 360 degrees, or any angle between 180 degrees and 360 degrees without kinking.

[0061] According to an embodiment of the present disclosure, the kerf width (CW1) of the plurality of transverse cuts at the outer surface is equal to or less than 47 microns, or equal to or less than 22 microns. In some embodiments, the kerf width (CW1) at the outer surface is equal to or less than 55 microns. According to an embodiment of the present disclosure, the range of the kerf width (CW1) at the outer surface is between 15 microns and 47 microns, or between 15 microns and 25 microns. In an embodiment, the kerf width at the outer surface in a portion of the tube member is between 23 microns and 47 microns. The kerf width (CW1) at the outer surface may be substantially constant along the cut.

[0062] According to an embodiment of the present disclosure, the kerf width (CW2) of the plurality of transverse cuts at the inner surface is equal to or less than 30 microns. In some embodiments, the kerf width (CW2) at the inner surface is equal to or less than 10 microns. According to an embodiment of the present disclosure, the kerf width (CW2) at the inner surface ranges between 10 microns and 30 microns. The kerf width (CW2) at the inner surface may be substantially constant along the cut.

[0063] According to an embodiment of the present disclosure, the plurality of transverse cutouts 210 having a tapered geometry are formed in a single beam cutout style. In the single beam cutout style, a single axially extending beam 214 connects a pair of adjacent circumferentially extending rings 212. Figure 6 An example of a single beam cutout pattern is shown. Figure 6 In the example shown, a series of beams 214 are arranged, for example, on the same side of the tube member to form a preferred bending direction of the tube member. In alternative embodiments, each continuous beam 214 can be rotationally offset relative to the previous beam and / or the next beam, for example, in an angular range between 5 degrees and 180 degrees. At different parts of the tube member, the continuous beams can be offset in a linear spiral pattern with a constant deflection angle, or in a nonlinear pattern with a random deflection angle, or in a combination of the two.

[0064] According to an embodiment of the present disclosure, a plurality of transverse cutouts 210 having a tapered geometry are formed in a double beam cutout pattern. In the double beam pattern, two axially extending beams 214 are formed between pairs of adjacent circumferentially extending rings 212. Figure 7 An example of a double beam cutout pattern is shown. Figure 7 In the example shown, the beam pairs 214 are arranged symmetrically, or the two beams 214 of the beam pair are equally spaced apart in the circumferential direction (180 degrees relative to each other). Alternatively, the beam pairs can be arranged asymmetrically, that is, the two beams 214 of the beam pair are closer in the circumferential direction (less than 180 degrees) or farther apart (greater than 180 degrees). Figure 7 In the example shown, the beam pairs are arranged to be rotationally offset 90 degrees from the previous and / or next beam pairs. Alternatively, the offset angle can be any angle between 1 and 90 degrees. In addition, in different parts of the tube member, consecutive beam pairs can be offset in a linear spiral pattern or a nonlinear pattern or a combination thereof. In some embodiments, a series of beam pairs are arranged to be aligned in the same plane.

[0065] According to an embodiment of the present disclosure, the plurality of transverse cutouts 210 having a tapered geometry are formed in a three-beam cutout pattern. In the three-beam cutout pattern, three beams 214 (a “beam set”) are formed between pairs of adjacent circumferentially extending rings 212 . Figure 8 An example of a three-beam cut pattern is shown. Like the two-beam cut pattern, the beams 214 in the three-beam cut pattern can be formed symmetrically, such as equally spaced at 120 degrees circumferentially, or asymmetrically. Similarly, the beam groups in the three-beam cut pattern can be arranged in a rotational offset from the previous and / or next beam group at an offset angle between 1 degree and 90 degrees. In different parts of the tube member, consecutive beam groups can be offset in a linear spiral pattern, or a nonlinear pattern, or a combination thereof.

[0066] Embodiments of the present disclosure provide a method for manufacturing a guide wire device. The method utilizes a laser to cut a tube member into a pattern and / or geometry that cannot be achieved by conventional techniques. Novel cut patterns and / or geometries provide a desired balance between bending flexibility, torsional rigidity, and tensile strength for the guide wire device. Advantageously, the cutting geometry allows the inner faces of adjacent circumferentially extending rings to meet flushly when bent, thereby allowing the guide wire device to bend with a smaller radius without kinking or deforming.

[0067] Fig. 9 300 is a flowchart showing example steps of a method 300 for manufacturing a guide wire device according to an embodiment of the present disclosure. In step 302, an elongated core wire is provided. The core wire may be made of a metal such as stainless steel, titanium, nickel titanium alloy, or Nitinol, or of other biocompatible materials. The core wire may be a single continuous wire extending substantially over the entire axial length of the guide wire device. The core wire may also be a multi-piece or multi-region structure, wherein each piece or each region is made of a different material having different properties, such as flexibility or rigidity. For example, the proximal portion or region of the core wire may be made of relatively rigid stainless steel to obtain better pushability and torquability, while the distal portion of the core wire may be made of relatively elastic Nitinol to obtain better maneuverability and trackability. The core wire may be solid, hollow, or have other internal structures.

[0068] The core wire can have a length sufficient to reach the target site in the patient's body. Typically, the length of the core wire ranges from 200 cm to 320 cm. The distal portion of the core wire can taper toward the distal end to provide greater bending flexibility. The tapered distal portion of the core wire can have a circular, rectangular or other regular or irregular cross-sectional shape. The proximal portion of the core wire can have an increased diameter to maintain the pushability and torsional rigidity of the guide wire device. Alternatively, the core wire has a circular cross-section and / or a constant diameter.

[0069] In some embodiments, the distal portion of the core wire is wrapped with a radiopaque coil for fluoroscopic imaging. Suitable materials for the radiopaque coil include platinum, gold, or other heavy metals.

[0070] At step 304, a tubular member is provided. The tubular member may be made of a metal, a metal alloy, a polymer, a metal-polymer composite, or any combination thereof. Suitable metals and metal alloys for the tubular member include stainless steel, nickel-titanium alloy or nitinol, or other nickel alloys, such as cobalt-chromium alloy, nickel-molybdenum alloy, nickel-copper alloy, nickel-cobalt alloy, other nickel-iron alloys, nickel-tungsten alloy, cobalt-chromium-molybdenum alloy, etc. Suitable polymers for the tubular member include polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), and other suitable polymeric materials.

[0071] The tubular member may have a length suitable for being a component of the distal end portion of the core wire coupled to a guidewire device. For example, the tubular member may have a length range, for example, from 10 cm to 55 cm, applied to a guidewire device. It should be noted that embodiments of the present disclosure may be applied to manufacture other medical devices, such as catheter devices, which may have a length suitable for use in catheter devices.

[0072] The tubular member may have an outer diameter, an inner diameter, and a wall thickness that are selected to provide one or more desired basic properties for a particular application, such as stiffness, flexibility, tensile strength, torque response, etc. In general, if the outer diameter of the tubular member increases and the wall thickness decreases, the tubular member may have the same bending stiffness and increased torque response, but some mechanical strength may be lost. In another example, if the outer diameter of the tube decreases and the wall thickness increases, the tubular member may have increased axial stiffness at the expense of reduced torque response at the same bending stiffness.

[0073] A plurality of transverse cuts or slots are formed in the tubular member at a plurality of axial locations of the tubular member at step 306. The plurality of transverse cuts formed in the tubular member form a plurality of circumferentially extending rings connected by a plurality of axially extending beams.

[0074] According to an embodiment of the present disclosure, a laser is used to form a plurality of cuts or grooves in a tube member. A laser beam or pulse can cut or remove material from a thin tubular component or tube member with high precision and high resolution without mechanical deformation or burrs. According to an embodiment of the present disclosure, a pattern and / or geometric shape of micron or submicron size is formed with a laser pulse. The laser cutting process can be automated or configured using computer software to achieve efficient high-speed processing.

[0075] Various types of lasers are available in the art and can be selected for use in the method of manufacturing the guidewire device of the present disclosure. According to an embodiment of the present disclosure, a gas-assisted laser is used to cut a tube member, wherein a pressurized gas jet or auxiliary gas is used to blow away the molten material, cool the material, and prevent it from warping or re-solidifying to improve the quality and efficiency of the cutting process.

[0076] The duration, frequency, shape and other parameters of the laser pulse can be set or selected based on the cutting size, geometry and cutting speed, etc. If the tube member is thin, a high pulse frequency and a short pulse duration can be used. The pulse duration is the time between the start and end of a single energy pulse, in seconds. The shorter the pulse duration, the greater the cutting effectiveness and the fewer burrs or defects (such as heat affected zones). In embodiments of the present disclosure, ultrashort pulses ranging from tens of picoseconds to femtoseconds can be used.

[0077] During the cutting process, a stage can be used to hold and / or move the tube member. The stage can be controlled by a precision motor system that can horizontally translate and / or rotate the tube member with micron or sub-micron precision. For example, during the cutting process, the tube member can be held and / or moved by the stage while the beam pulses from the laser source are aimed and deposited on the tube member. In some embodiments, the laser source includes a series of optical devices that can be controlled and / or adjusted while the tube member is held and / or moved by the stage during the cutting process.

[0078] In an embodiment, the tube member is held at a fixed axial position. When the tube member is rotated or turned at the fixed axial position, the laser source can be activated to deposit a beam pulse onto the tube member to form a cut having a predetermined cut width and / or length. The cut can be a transverse cut formed in a plane perpendicular to the longitudinal axis of the tube member, or a transverse cut formed in a plane at an angle to the plane perpendicular to the longitudinal axis of the tube member. After achieving the desired cut length (measured in degrees), the laser source can be turned off.

[0079] In an embodiment, the tube member is held at a first axial position. When the tube member is rotated at the first axial position, pulses of the laser beam may be irradiated onto the tube member. A first transverse cut is formed at the first axial position of the tube member. Then, the tube member is translated to a second axial position. When the tube member is rotated at the second axial position, pulses of the laser beam may be deposited onto the tube member. A second transverse cut is formed at the second axial position of the tube member. In this way, multiple transverse cuts may be formed at multiple axial positions of the tube member.

[0080] In an embodiment, the tube member is translated from a first axial position to a second axial position and rotates during the translation. While the tube member is translating and rotating, pulses of the laser beam can be deposited onto the tube member. In this way, a spiral cut extending between the first axial position and the second axial position of the tube member can be formed in the tube member. The laser source can be turned on and off while the tube member is simultaneously translated and rotated to form a plurality of spiral cuts.

[0081] In an embodiment, the laser source can be configured to provide a beam pulse suitable for cutting a tube member having a tapered geometry. For example, the laser source can be configured to deposit a beam pulse with a suitable focus so that more tube material is removed at the outer surface of the tube member than at the inner surface, thereby forming a cut having a tapered geometry, wherein the cut width at the outer surface is greater than the cut width at the inner surface.

[0082] A cutout having a tapered geometry is beneficial because the inner faces or surfaces of adjacent circumferentially extending rings may meet in a flush manner, thereby allowing the tubular member to bend at smaller bend angles without kinking or deforming. Fig. 10A 2 is a cross-sectional side view of a tube member 200 having a cutout 210 with a tapered geometry according to an embodiment of the present disclosure. As shown, the tube member 200 has an outer surface 202 and an inner surface 204. The cutout 210 in the tube member 200 forms two circumferentially extending rings 212 connected by an axially extending beam 214. The cutout 210 has a tapered geometry through the thickness of the tube member 200 between the outer surface 202 and the inner surface 204. The chamfered surfaces or inner surfaces 218 of adjacent circumferentially extending rings 212 form a tapered angle ( X ).like Fig. 10B As shown, when the tube member 200 is bent to the maximum extent, the inner surfaces 218 of the adjacent rings 212 meet flushly, so that the outer edges 219 of the adjacent rings 212 are in contact without deformation when the tube member 200 is bent to the maximum extent. Fig.11A and Fig. 11B This is in contrast to the conventional straight or vertical cutout 210' shown formed in the tubular member 200', in which the edge 219' of the adjacent circumferentially extending ring 212' would impinge or prevent the tubular member 200' from intersecting with the tubular member 200'. Fig. 10A and Fig. 10B bends at the same maximum bend angle without kinking or deforming.

[0083] refer to Fig.12 According to an embodiment of the present disclosure, the appropriate taper angle of the cutout 210 ( X ) can be determined by drawing an isosceles triangle 230, where the height of triangle 230 is equal to the inner radius of tube member 200 ( r ) minus the height of the axially extending beam 214 ( b ), and the base of the triangle is the cut width at the inner surface 204 of the tube member 200 ( c ). This assumes that adjacent circumferentially extending rings 212 connected by axially extending beams 214 contact the inner diameter 204 of the tubular member 200 when bent, thereby forming a triangle 230. This yields the following equation: X = 2 arcsin [( c / 2) / ( r-b / 2)] in X represents the cone angle, c represents the cut width at the inner surface of the pipe component, r represents the inner radius of the pipe component, and b represents the height of the beam adjacent to the cutout. Once the above equation is used for a given pipe member ( r ) on the desired cut width ( c ) and beam height ( b ) determines the cone angle ( X ), the cone angle can be used as a target or guide for selecting or configuring a series of optical devices in the laser source to provide laser beam pulses with the appropriate focal angle to perform the cutting.

[0084] Fig.13 Schematically illustrated is a collimated laser beam 232 shaped by a series of optics (not shown) passing through a focusing lens 234 to form a laser beam 236 having a focal angle (θ). The focused laser beam 236 is deposited onto the tube member 200 to form a through cut wherein more tube member material is removed at or adjacent the outer surface of the tube member than at or adjacent the inner surface of the tube member, thereby forming a tapered geometry through the thickness of the tube member.

[0085] According to embodiments of the present disclosure, the optics of the laser source may be arranged or selected to provide a focal angle (θ) substantially equal to the cone angle (θ) of the cut to be formed in the tube member. X ). According to some embodiments of the present disclosure, the optics of the laser source may be arranged or selected to provide a focal angle (θ) that is smaller than the cone angle ( X) The laser beam can be adjusted within a 5 degree (+ / - 5°) range to accommodate changes in the focal length of the laser beam and cutting power. Fig.14 is an enlarged view of a portion of a tube member cut by a laser beam having a focal angle (θ), showing cutting features and parameters ( r, c, b, X ).

[0086] According to an embodiment of the present disclosure, a series of optical devices of a laser source are arranged or configured to provide laser beam pulses to form a cone angle ( X ) incisions in the range of about 8 degrees to about 25 degrees.

[0087] According to an embodiment of the present disclosure, a series of optical devices of the laser source are arranged or configured to provide laser beam pulses to form a cut in the tube member, the cut width at the outer surface of which is equal to or less than 47 microns. In some embodiments, the cut width at the outer surface is equal to or less than 22 microns. In an embodiment, the range of the cut width at the outer surface is between 15 microns and 47 microns. In an embodiment, the range of the cut width at the outer surface is between 15 microns and 25 microns. In an embodiment, the range of the cut width at the outer surface of a portion of the tube member is between 23 microns and 47 microns.

[0088] According to an embodiment of the present disclosure, a series of optical devices of the laser source are arranged or configured to provide laser beam pulses to form a cut in the tube member, the cut width at the inner surface of which is equal to or less than 30 microns. In some embodiments, the cut width at the inner surface is equal to or less than 10 microns. According to an embodiment of the present disclosure, the cut width at the inner surface ranges between 10 microns and 30 microns.

[0089] Return to Fig. 9 At step 308, a tubular member is bonded to the distal end portion of the elongated core wire. The tubular member may be bonded to the distal end portion of the core wire using, for example, adhesives, welding, soldering, etc. at one or more attachment points.

[0090] The cutting process may be automated using computer software that may be configured or programmed to control the movement of a stage supporting the tube member and / or the operation of a laser source providing the beam pulses.

[0091] Example A commercially available laser source was used to cut a tube member supported by a stage controlled by a motor system. The outer diameter of the tube member was 0.013 inches, the inner diameter was 0.0096 inches, and the length was 35 cm. A series of cuts were formed in the tube member, the cut width at the outer diameter was 31 microns, and the cut width at the inner diameter was 14 microns. The cut had a conical geometry with a cone angle of 22°. The cutting length ranged from about 160° at the tip where a smaller bending radius was required to about 63° at the other end. More than 5,000 cuts were produced in the tube member, of which 616 were located within a portion 1 cm from the tip where a smaller bending radius was required.

[0092] Various embodiments of guidewire devices and methods for manufacturing guidewire devices have been described with reference to the accompanying drawings. It should be noted that the aspects described in conjunction with a specific embodiment are not necessarily limited to that embodiment, but may be implemented in any other embodiment. The accompanying drawings are intended to illustrate the embodiments, rather than to describe or limit the scope of the present disclosure in detail. Without departing from the principles of the claims of the present invention, other structures, components and materials will be easily considered feasible. In addition, although some embodiments of the present disclosure are described in conjunction with guidewire devices, this is not meant to be restrictive. For example, a tubular member including a transverse incision with a tapered geometry can be configured as or used as a catheter device, and / or as a component of other interventional devices.

[0093] Unless otherwise expressly defined, all technical and scientific terms used herein have the meanings commonly understood by those of ordinary skill in the art. As used in the specification and the appended claims, the singular forms "a", "an" and "the" include plural forms unless the context clearly dictates otherwise. The term "or" refers to a non-exclusive "or" unless the context clearly dictates otherwise. The term "proximal" and its grammatical equivalents refer to a position, direction or orientation toward a user or doctor's side. The term "distal" and its grammatical equivalents refer to a position, direction or orientation away from a user or doctor's side. The names "backward", "forward", etc. are not meant to limit the reference component to a specific orientation. It should be understood that such names refer to the direction of the reference component shown in the accompanying drawings; the systems and devices of the present disclosure can be used in any direction suitable for the user. When describing various similar elements, the terms "first" or "second" and the like can be used to distinguish one element from another. It should be noted that the terms "first" and "second" used herein include reference to two or more. In addition, the use of the terms "first" or "second" should not be interpreted as any particular order unless the context clearly dictates otherwise. In other embodiments, the order in which the method steps are performed may be changed. One or more method steps may be skipped entirely, and one or more optional steps may also be included. All numerical values ​​are provided for illustration and are assumed to be modified by the term "about", whether or not explicitly indicated. The term "about" generally refers to a numerical range that one skilled in the art would consider equivalent to the numerical value, e.g., having the same function or result. The term "about" may include numbers rounded to the nearest significant figure. Numerical ranges expressed as endpoints include all numbers within the range.

[0094] Those skilled in the art will appreciate that various other modifications may be made. All of these or other changes and modifications are contemplated by the inventor and are within the scope of the present invention.

Claims

1. A guide wire device, comprising: an elongated core wire extending between the proximal portion and the distal portion; as well as a tubular member on the distal portion of the elongated core wire, the tubular member having an outer surface and an inner surface, wherein The tube member includes a plurality of transverse cuts at a plurality of axial locations of the tube member to form a plurality of circumferentially extending rings connected by a plurality of beams, wherein the plurality of transverse cuts include a tapered geometry and a cut width at the outer surface of the tube member is greater than a cut width at the inner surface of the tube member.

2. The guide wire device according to claim 1, wherein: The tapered geometry of at least one of the plurality of transverse cuts comprises a taper angle satisfying the following equation: X : X = 2 arcsin [( c / 2) / ( r-b / 2)] wherein c represents the cut width of the at least one transverse cut of the plurality of transverse cuts at the inner surface, r represents the inner radius of the tube member, and b represents the beam height of the beam adjacent to the at least one transverse cut of the plurality of transverse cuts.

3. The guide wire device according to claim 1, wherein: The tapered geometry of at least one of the plurality of transverse cuts forms chamfered inner faces of a pair of circumferentially extending rings adjacent the at least one of the plurality of transverse cuts, wherein the chamfered inner faces meet flush when the tubular member is bent at an angle.

4. The guide wire device according to claim 1, wherein: The tapered geometry of at least one of the plurality of transverse cuts comprises a taper angle ranging from about 8 degrees to about 25 degrees. X .

5. The guide wire device according to claim 1, wherein: The cut width at the inner surface of the tube member is equal to or smaller than 30 micrometers.

6. The guide wire device according to claim 1, wherein: The cut width at the outer surface of the tube member is equal to or less than 47 micrometers.

7. The guide wire device according to claim 1, wherein: The cut width at the outer surface of the tube member is equal to or less than 22 micrometers.

8. The guide wire device according to claim 1, wherein: The plurality of transverse cuts extend in a plane that is substantially perpendicular to the longitudinal axis of the tubular member.

9. The guide wire device according to claim 1, wherein: The plurality of transverse cuts comprises a single beam cut pattern.

10. The guide wire device according to claim 1, wherein: The plurality of transverse cuts comprises a double beam cut pattern.

11. The guide wire device according to claim 1, wherein: The plurality of transverse cuts comprises a three-beam cut pattern.

12. The guide wire device according to claim 1, wherein: The pipe member includes a metal pipe.

13. The guide wire device according to claim 1, wherein: The tube member comprises a polymer tube.

14. The guidewire device of claim 1, further comprising a radiopaque coil positioned between the tubular member and the elongated core wire.

15. A method of manufacturing a guidewire device, the method comprising: Provides a thin and long core wire; providing a tubular member having an outer surface and an inner surface; forming a plurality of transverse cuts in the tube member at a plurality of axial locations of the tube member to produce a plurality of circumferentially extending rings connected by a plurality of beams, wherein the plurality of transverse cuts are formed by using a laser to remove more material at the outer surface of the tube member than at the inner surface to form the plurality of transverse cuts having a tapered geometry, wherein a width of the cut at the outer surface is greater than a width of the cut at the inner surface; as well as The tubular member is coupled to a distal portion of the elongated core wire.

16. The method according to claim 15, wherein: The tapered geometry of at least one of the plurality of transverse cuts comprises a taper angle satisfying the following equation: X : X = 2 arcsin [( c / 2) / ( r-b / 2)] wherein c represents the cut width of the at least one transverse cut of the plurality of transverse cuts at the inner surface, r represents the inner radius of the tube member, and b represents the beam height of the beam adjacent to the at least one transverse cut of the plurality of transverse cuts.

17. The method of claim 16, wherein: The tapered geometry of at least one transverse cut of the plurality of transverse cuts includes a taper angle ranging from about 8 degrees to about 25 degrees.

18. The method of claim 16, wherein: The laser is configured to provide beam pulses having a focal angle equal to, or within 5 degrees greater or less than, a cone angle of the at least one of the plurality of transverse cuts.

19. The method according to claim 15, wherein: The cut width at the inner surface of the tube member is equal to or smaller than 30 micrometers.

20. The method according to claim 15, wherein: The cut width at the outer surface of the tube member is equal to or less than 47 micrometers.

21. The method according to claim 15, wherein: The cut width at the outer surface of the tube member is equal to or less than 22 micrometers.

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