Guidewires and medical devices including laser-cut tubes

Abstract

A guidewire device includes an elongated core wire and a tubular member positioned at a distal end portion of the elongated core wire. The tubular member includes 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. 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.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] 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

[0003] The present application generally relates to medical devices and methods of making and using medical devices to treat diseases. In particular, various embodiments of guidewire devices and methods of making the same are described. Background Art

[0004] Guidewires are widely used in the medical field to guide devices to specific locations within the patient's body for delicate procedures, such as guiding a catheter deep into a blood vessel. Guidewires typically require a variable stiffness profile, typically with the most flexible portion at the distal end, while maintaining good torque transmission for tracking and delivery through tortuous anatomy. It is important to ensure that the guidewire's tip can be bent to a small radius to form a curved shape that facilitates vessel selection.

[0005] Guidewires typically consist of a core wire, which may have a tapered distal end and is reinforced with a structure connected to an atraumatic tip. Traditionally, metal coils have been used as guidewire reinforcements. With the advancement 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 achieved with hypotubes.

[0006] 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 with conventional techniques. It would be desirable to provide a new technique for achieving cutting geometries on guidewire devices that balance the complex requirements of various medical applications for bending flexibility, tensile strength, and torque transmission, and allow the guidewire tip to achieve a smaller bend radius without kinking. Summary of the Invention

[0007] In one aspect, embodiments of the present disclosure are based on a guidewire device. Typically, embodiments of the guidewire device include an elongated core wire and a tubular member at a distal end 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.

[0008] In various embodiments of this aspect, the tapered geometry of at least one of the plurality of transverse cuts comprises a cone angle satisfying the following equation: X ):

[0009] X = 2 arcsin [( c / 2) / ( r-b / 2)]

[0010] in, c represents the cut width of 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 at least one of the plurality of transverse cuts is represented.

[0011] 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.

[0012] In various embodiments of this aspect, the tapered geometry of at least one transverse cut of the plurality of transverse cuts comprises a taper angle ranging from about 8 degrees to about 25 degrees ( X ).

[0013] 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.

[0014] 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.

[0015] 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.

[0016] In various embodiments of this aspect, the plurality of transverse cuts comprises a single beam cut pattern.

[0017] In various embodiments of this aspect, the plurality of transverse cuts comprises a double beam cut pattern.

[0018] In various embodiments of this aspect, the plurality of transverse cuts comprises a three-beam cut pattern.

[0019] In various embodiments of this aspect, the tubular member comprises a metal tube.

[0020] In various embodiments of this aspect, the tubular member comprises a polymeric tube.

[0021] In various embodiments of this aspect, the guidewire device further comprises a radiopaque coil positioned between the tubular member and the elongated core wire.

[0022] 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:

[0023] Provides a thin and long core wire;

[0024] providing a tubular member having an outer surface and an inner surface;

[0025] forming a plurality of transverse cuts in the tubular member at a plurality of axial locations of the tubular 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 tubular 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

[0026] The tubular member is coupled to the distal end portion of the elongated core wire.

[0027] In various embodiments of this aspect, the tapered geometry of at least one of the plurality of transverse cuts comprises a cone angle satisfying the following equation: X ):

[0028] X = 2 arcsin [( c / 2) / ( r-b / 2)]

[0029] in, crepresents 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 cutout of the plurality of transverse cutouts.

[0030] 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） .

[0031] In various embodiments of this aspect, the laser is configured to provide beam pulses having a focal angle equal to, or within 5 degrees greater than or less than, a cone angle of the at least one of the plurality of transverse cuts.

[0032] 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.

[0033] 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.

[0034] 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.

[0035] In another aspect, embodiments of the present disclosure feature a tubular member for a medical device. Generally, embodiments of the tubular member include a plurality of transverse cuts located at multiple axial locations on 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 cut width at the outer surface of the tubular member is greater than the cut width at the inner surface of the tubular member.

[0036] In various embodiments of this aspect, the tapered geometry of at least one of the plurality of transverse cuts comprises a cone angle satisfying the following equation: X ):

[0037] X= 2 arcsin [( c / 2) / ( r-b / 2)]

[0038] in, c represents the cut width of 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 cutout of the plurality of transverse cutouts.

[0039] 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.

[0040] In various embodiments of this aspect, the tapered geometry of at least one transverse cut of the plurality of transverse cuts comprises a taper angle ranging from about 8 degrees to about 25 degrees ( X ).

[0041] 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.

[0042] 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.

[0043] 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.

[0044] In various embodiments of this aspect, the plurality of transverse cuts comprises a single beam cut pattern.

[0045] In various embodiments of this aspect, the plurality of transverse cuts comprises a double beam cut pattern.

[0046] In various embodiments of this aspect, the plurality of transverse cuts comprises a three-beam cut pattern.

[0047] In various embodiments of this aspect, the tubular member comprises a metal tube.

[0048] In various embodiments of this aspect, the tubular member comprises a polymeric tube.

[0049] This Summary is provided to introduce selected aspects and embodiments of the present disclosure in a simplified form. It 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 solely to provide the reader with a summary of certain possible forms of the present invention and are not intended to limit the scope of the invention. Other aspects and embodiments of the present disclosure are described in the Detailed Description.

[0050] 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

[0051] Figure 1 is a simplified illustration of an example guidewire device according to an embodiment of the present disclosure.

[0052] 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.

[0053] 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.

[0054] 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.

[0055] Figure 5 Example tapered cutout geometries are shown according to embodiments of the present disclosure.

[0056] Figure 6 is a simplified illustration of a tubular member including multiple cutouts in a single beam cutout pattern according to an embodiment of the present disclosure.

[0057] Figure 7 is a simplified illustration of a tubular member including multiple cutouts in a dual beam cutout pattern according to an embodiment of the present disclosure.

[0058] 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.

[0059] Figure 9is a flow chart illustrating example steps of a method of manufacturing a guidewire device according to an embodiment of the present disclosure.

[0060] Figure 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. Figure 10B Schematically shown Figure 10A The bending of the pipe components during use.

[0061] Figure 11A is a simplified illustration showing a side view of a vertical cut in a tube member for comparison. Figure 11B Schematically shown Figure 11A The bending of the pipe components during use.

[0062] Figure 12 is a simplified diagram showing some parameters of a cutout in a pipe member.

[0063] Figure 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.

[0064] Figure 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

[0065] 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 the embodiments of the present disclosure and are not necessarily drawn to scale. Certain specific details may be listed in the 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 the 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 the embodiments of the present disclosure.

[0066] Embodiments of the present disclosure provide a guidewire device comprising a tubular member coupled to a distal portion of an elongated core wire for enhanced 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 bend 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 not achievable with conventional techniques.

[0067] 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 can taper toward the distal end to provide greater bending flexibility. The proximal portion 104 of the core wire 102 can have an increased diameter to maintain the pushability and torsional stiffness 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 can be joined 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 torsional forces 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 metal, can be provided for fluoroscopic imaging in the form of a coil wrapped around and / or adhered to the core wire 102, for example. An atraumatic tip 110, such as a rounded shape, can be formed at the distal end of the guidewire device 100 to prevent damage to blood vessels. According to an embodiment of the present disclosure, tubular member 200 includes a plurality of cutouts 210 configured to improve the effectiveness of guidewire device 100, for example, achieving a desired balance between bending flexibility, torsional stiffness, and tensile strength, as will be described in greater detail below.

[0068] refer to Figure 2, shows an example tubular member 200 including a plurality of cutouts or slots 210. The tubular 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 cutouts 210 are formed at various axial locations in the tubular 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 location" is used to refer to a location along the longitudinal axis 201 of the tubular member 200. The term "transverse cutout" 210 refers to a cutout or slot in the tubular member 200 that extends in a plane transverse to the longitudinal axis 201 of the tubular member 200. The transverse cutout 210 can be formed in a plane substantially perpendicular to the longitudinal axis 201 of the tubular member 200. The transverse cutout 210 can also be formed at an angle, for example, from 5 to 45 degrees relative to the plane perpendicular to the longitudinal axis 201 of the tubular 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 the uncut annular structure in the tubular member 200 that extends circumferentially around the longitudinal axis 201 of the tubular member 200. The term "beam" 214 refers to the uncut portion of the tubular 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 tubular 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.

[0069] refer to Figure 3 and Figure 5 According to an embodiment of the present disclosure, a tubular member 200 is provided with a plurality of transverse cuts 210 having a tapered geometry at various axial locations of the tubular member 200. The transverse cuts 210 having a tapered geometry have a first cut width (CW1) at the outer surface 202 of the tubular member and a second cut width (CW2) at the inner surface 204 of the tubular member 200, wherein the first cut width (CW1) is greater than the second cut width (CW2), i.e., more tubular material is removed from the outer surface 202 of the tubular member 200 than from the inner surface 204. The plurality of transverse cuts 210 having a tapered geometry in the tubular member 200 creates a plurality of circumferentially extending rings 212 having a tapered geometry in the cross-section of the rings. 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 ).

[0070] refer to Figure 3In an embodiment, a plurality of transverse cuts 210 having a tapered geometry are formed on the same side of the tubular member 200, thereby forming a plurality of circumferentially extending rings 212 on 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.

[0071] Figure 4 The bending radius of a pipe member 200 according to the present disclosure (left figure) is compared with that of a conventional pipe member 200' (right figure), both having the same pipe thickness. The pipe member 200 according to the present disclosure is provided with multiple cutouts having a tapered geometry, while the conventional pipe member 200' is provided with multiple cutouts having a perpendicular geometry. When the pipe member 200 according to the present disclosure is bent, for example, toward the side provided with the cutouts 210, the circumferentially extending rings 212 will converge on the outer surface 202 of the pipe member 200 and separate on the inner surface 204 of the pipe member 200. Similarly, when the conventional pipe member 200' is bent toward the side provided with the cutouts, the circumferentially extending rings 212' will converge on the outer surface of the pipe member 200' and separate on the inner surface of the pipe member 200'. If the tubular member 200, 200' bends sufficiently, the rings 212, 212' will collide on the outer surface side, preventing the tubular member 200, 200' from bending any further without kinking. A conventional tubular member 200' provided with multiple vertical cuts 212' allows bending at a radius of R1. With the tapered cuts 210 according to the present disclosure, which remove more material from the outer surface 202 of the tubular member 200, adjacent rings 212 have a larger gap at the outer surface 202 of the tubular member 200, thereby allowing the tubular member 200 to bend further before the rings 212 collide with the outer surface 202 of the tubular member 200, thereby allowing the tubular member 200 to bend at a tighter or smaller radius R2.

[0072] 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 adjacent circumferentially extending rings 212 form the tapered angle ( X Before the ring 212 collides with the outer surface 202 of the tubular 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 cone angle of the transverse cutout 210 ( X ) can be in the range of 8 degrees to 25 degrees. Select the appropriate cone angle ( X Other considerations include the diameter and thickness of the tube member 200, and the desired bend radius (R) of the tube member 200. According to an embodiment of the present disclosure, the taper angle ( X) to allow the tubular 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.

[0073] According to embodiments 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 embodiments of the present disclosure, the kerf width (CW1) at the outer surface ranges from 15 microns to 47 microns, or from 15 microns to 25 microns. In embodiments, the kerf width at the outer surface of a portion of the tubular member ranges from 23 microns to 47 microns. The kerf width (CW1) at the outer surface can be substantially constant along the length of the cut.

[0074] According to embodiments 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 embodiments 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 can be substantially constant along the length of the cut.

[0075] 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 illustrated example, a series of beams 214 are arranged, for example, along the same side of the tubular member to define a preferred bending direction for the tubular member. In alternative embodiments, each successive beam 214 can be rotationally offset relative to the preceding and / or succeeding beam by an angle ranging, for example, between 5 and 180 degrees. At different portions of the tubular member, the successive beams can be offset in a linear, helical pattern with a constant skew angle, or in a nonlinear pattern with random skew angles, or in a combination of both.

[0076] According to an embodiment of the present disclosure, a plurality of transverse cuts 210 having a tapered geometry are formed in a double beam cut pattern. In the double beam pattern, two axially extending beams 214 are formed between a pair of adjacent circumferentially extending rings 212. Figure 7 An example of a double beam cutout style 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 circumferentially (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 together (less than 180 degrees) or farther apart (greater than 180 degrees) in the circumferential direction. Figure 7 In the example shown, the beam pairs are arranged rotationally offset by 90 degrees from the preceding and / or succeeding beam pairs. Alternatively, the offset angle can be any angle between 1 and 90 degrees. Furthermore, in different sections of the tubular member, successive beam pairs can be offset in a linear helical pattern, a nonlinear pattern, or a combination thereof. In some embodiments, a series of beam pairs are arranged so as to be aligned in the same plane.

[0077] According to an embodiment of the present disclosure, a plurality of transverse cuts 210 having a tapered geometry are formed in a three-beam cut pattern. In the three-beam cut 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, for example, equally spaced at 120 degrees circumferentially, or asymmetrically. Similarly, the beam groups in the three-beam cut pattern can be rotationally offset from the previous and / or subsequent beam groups at an offset angle between 1 and 90 degrees. In different sections of the tubular member, successive beam groups can be offset in a linear helical pattern, a nonlinear pattern, or a combination thereof.

[0078] 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. The novel cut pattern and / or geometry provides 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.

[0079] Figure 9 is a flow chart illustrating example steps of a method 300 for manufacturing a guidewire device according to an embodiment of the present disclosure. In step 302, an elongated core wire is provided. The core wire can be made of a metal such as stainless steel, titanium, nickel titanium alloy, or Nitinol, or made of other biocompatible materials. The core wire can be a single continuous wire that extends substantially the entire axial length of the guidewire device. The core wire can also be a multi-piece or multi-region structure, where each piece or each region is made of a different material with different properties (such as flexibility or rigidity). For example, the proximal portion or region of the core wire can be made of relatively rigid stainless steel to achieve better pushability and twistability, while the distal portion of the core wire can be made of relatively flexible Nitinol to achieve better maneuverability and trackability. The core wire can be solid, hollow, or have other internal structures.

[0080] 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.

[0081] 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.

[0082] At step 304, a tubular member is provided. The tubular member can 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.

[0083] The tubular member can have a length suitable for use as a component of a distal end portion of a core wire coupled to a guidewire device. For example, the tubular member can have a length ranging from 10 cm to 55 cm, for example, for use with a guidewire device. It should be noted that embodiments of the present disclosure can be applied to manufacture other medical devices, such as catheter devices, and can have a length suitable for use with a catheter device.

[0084] Tubular components can 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. Generally, if the outer diameter of a tubular component is increased while the wall thickness is decreased, the tubular component can have the same bending stiffness and increased torque response, but with some loss of mechanical strength. In another example, if the outer diameter of the tube is decreased while the wall thickness is increased, the tubular component can have increased axial stiffness at the expense of reduced torque response for the same bending stiffness.

[0085] 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.

[0086] According to embodiments of the present disclosure, lasers are used to form multiple cuts or grooves in tubular components. Laser beams or pulses can cut or remove material from thin tubular components or tubular components with high precision and resolution, without mechanical deformation or burrs. According to embodiments of the present disclosure, laser pulses are used to form micron or submicron-sized patterns and / or geometric shapes. The laser cutting process can be automated or configured using computer software to achieve efficient, high-speed processing.

[0087] 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 the tubular component, wherein a pressurized gas jet or assist gas is utilized to blow away the molten material, cool the material, and prevent it from warping or resolidifying, thereby improving the quality and efficiency of the cutting process.

[0088] 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. For thin tube components, a high pulse frequency and short pulse duration can be used. Pulse duration is the time, measured in seconds, between the start and end of a single energy pulse. Shorter pulse durations increase cutting effectiveness and reduce 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.

[0089] During the cutting process, a stage can be used to hold and / or move the tubular member. The stage can be controlled by a precision motor system that can horizontally translate and / or rotate the tubular member with micron or submicron precision. For example, during the cutting process, the tubular member can be held and / or moved by the stage while the beam pulses from a laser source are aimed and deposited on the tubular member. In some embodiments, the laser source includes a series of optical devices that can be controlled and / or adjusted while the tubular member is held and / or moved by the stage during the cutting process.

[0090] In an embodiment, the tubular member is held at a fixed axial position. As the tubular member rotates or turns in the fixed axial position, a laser source can be activated to deposit a beam pulse onto the tubular member to form an incision having a predetermined incision width and / or length. The incision can be a transverse incision formed in a plane perpendicular to the longitudinal axis of the tubular member, or in a plane angled relative to the plane perpendicular to the longitudinal axis of the tubular member. After the desired cut length (measured in degrees) is achieved, the laser source can be turned off.

[0091] In an embodiment, the tubular member is held in a first axial position. As the tubular member rotates in the first axial position, pulses of the laser beam can be directed onto the tubular member. A first transverse cut is formed at the first axial position of the tubular member. The tubular member is then translated to a second axial position. As the tubular member rotates in the second axial position, pulses of the laser beam can be deposited onto the tubular member. A second transverse cut is formed at the second axial position of the tubular member. In this manner, multiple transverse cuts can be formed at multiple axial positions of the tubular member.

[0092] In an embodiment, a tubular member is translated from a first axial position to a second axial position and rotated during the translation. Pulses of a laser beam can be deposited onto the tubular member while the tubular member translates and rotates. In this manner, a spiral cut extending between the first and second axial positions of the tubular member can be formed in the tubular member. The laser source can be turned on and off while the tubular member is simultaneously translated and rotated to form the plurality of spiral cuts.

[0093] In an embodiment, the laser source can be configured to provide beam pulses suitable for cutting a tubular member having a tapered geometry. For example, the laser source can be configured to deposit beam pulses having a suitable focus such that more tubular material is removed at the outer surface of the tubular 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.

[0094] Cutouts having a tapered geometry are beneficial because the inner faces or surfaces of adjacent circumferentially extending rings can meet in a flush manner, thereby allowing the tubular member to bend at smaller bend angles without kinking or deforming. Figure 10A FIG2 is a cross-sectional side view of a tubular member 200 having a cutout 210 with a tapered geometry according to an embodiment of the present disclosure. As shown, the tubular member 200 has an outer surface 202 and an inner surface 204. The cutout 210 in the tubular 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 tubular 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 Figure 10B As shown, when the pipe 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 pipe member 200 is bent to the maximum extent. Figure 11A and Figure 11B This is in contrast to the conventional straight or vertical cutout 210' shown formed in the tubular member 200' where the edge 219' of the adjacent circumferentially extending ring 212' would impinge on or prevent the tubular member 200' from intersecting with the tubular member 200'. Figure 10A and Figure 10B bends in the same maximum bend angle without kinking or deforming.

[0095] refer to Figure 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 the triangle 230 is equal to the inner radius of the 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:

[0096] X = 2 arcsin [( c / 2) / ( r-b / 2)]

[0097] in X represents the cone angle, c represents the cut width at the inner surface of the pipe member, r represents the inner radius of the pipe member, and b represents the height of the beam adjacent to the cutout. Once the above equation is used based on the given pipe member ( r ) on the desired kerf 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 components in the laser source to provide laser beam pulses with the appropriate focal angle to perform the cutting.

[0098] Figure 13 Schematically, a collimated laser beam 232 shaped by a series of optical devices (not shown) passes 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 in which more tube member material is removed at or near the outer surface of the tube member than at or near the inner surface of the tube member, thereby forming a tapered geometry through the thickness of the tube member.

[0099] 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 range of 5 degrees (+ / - 5°) to accommodate changes in the laser beam focal length and cutting power. Figure 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 ).

[0100] 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.

[0101] 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 an incision in a tube member, wherein the incision width at the outer surface thereof is equal to or less than 47 microns. In some embodiments, the incision width at the outer surface is equal to or less than 22 microns. In an embodiment, the incision width at the outer surface ranges from 15 microns to 47 microns. In an embodiment, the incision width at the outer surface ranges from 15 microns to 25 microns. In an embodiment, the incision width at the outer surface of a portion of the tube member ranges from 23 microns to 47 microns.

[0102] 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 an incision in a tube member, wherein the incision width at the inner surface thereof is equal to or less than 30 microns. In some embodiments, the incision width at the inner surface is equal to or less than 10 microns. According to an embodiment of the present disclosure, the incision width at the inner surface ranges from 10 microns to 30 microns.

[0103] Return to Figure 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.

[0104] 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.

[0105] Example

[0106] A commercially available laser source was used to cut a tubular member supported by a stage controlled by a motor system. The tubular member had an outer diameter of 0.013 inches, an inner diameter of 0.0096 inches, and a length of 35 cm. A series of cuts were made in the tubular member, with a cut width of 31 microns at the outer diameter and a cut width of 14 microns at the inner diameter. The cuts had a conical geometry with a cone angle of 22°. The cut lengths ranged from approximately 160° at the tip where a smaller bending radius was required to approximately 63° at the other end. More than 5,000 cuts were made in the tubular member, of which 616 were located within a portion 1 cm from the tip where a smaller bending radius was required.

[0107] Various embodiments of guidewire devices and methods of manufacturing guidewire devices have been described with reference to the accompanying drawings. It should be noted that the aspects described in conjunction with a particular 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 in detail or limit the scope of the present disclosure. Other structures, components and materials will be readily considered feasible without departing from the principles of the claims of the present invention. In addition, although some embodiments of the present disclosure have been described in conjunction with guidewire devices, this is not meant to be restrictive. For example, a tubular member comprising a transverse incision having a tapered geometry can be configured as or used as a catheter device, and / or as a component of other interventional devices.

[0108] Unless expressly defined otherwise, all technical and scientific terms used herein have the meanings commonly understood by one of ordinary skill in the art. As used in the specification and appended claims, the singular forms "a," "an," and "the" include the 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 the side of a user or physician. The term "distal" and its grammatical equivalents refer to a position, direction, or orientation away from the side of a user or physician. The designations "rearward," "forward," and the like are not intended to limit the referenced components to a particular orientation. It should be understood that such designations refer to the orientation of the referenced components as shown in the drawings; the systems and devices of the present disclosure can be used in any orientation suitable for the user. When describing various similar components, the terms "first" or "second," etc., may be used to distinguish one component from another. It should be noted that the terms "first" and "second" as used herein include reference to two or more components. Furthermore, the use of the terms "first" or "second" should not be construed to imply 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, or one or more optional steps may be included. All numerical values ​​are provided for illustration and are assumed to be modified by the term "about," whether or not explicitly stated. The term "about" generally refers to a range of values ​​that one skilled in the art would consider equivalent to the stated 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 that range.

[0109] Those skilled in the art will appreciate that various other modifications may be made. All of these and other changes and modifications are contemplated by the inventors and are within the scope of the invention.

Claims

1. A guide wire device, comprising: an elongated core wire extending between a proximal portion and a 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 tubular member including a plurality of transverse cuts at a plurality of axial locations on 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 a cut width at the outer surface of the tubular member is greater than a cut width at the inner surface of the tubular member; The tapered geometry of at least one of the plurality of transverse cuts comprises a cone angle satisfying the equation X : X = 2 arcsin [( c / 2) / ( r-b / 2)] wherein c represents a cut width of the at least one transverse cut of the plurality of transverse cuts at the inner surface, r represents an inner radius of the pipe member, and b represents a beam height of a beam adjacent to the at least one transverse cut of the plurality of transverse cuts.

2. 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.

3. 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 .

4. 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.

5. The guide wire device according to claim 1, wherein: The cut width at the outer surface of the tube member is equal to or smaller than 47 micrometers. The guide wire device according to claim 1 , wherein: The cut width at the outer surface of the tube member is equal to or smaller than 22 micrometers.

7. 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.

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

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

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

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

12. The guide wire device according to claim 1, wherein: The tubular member comprises a polymeric tube.

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

14. 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 tubular member at a plurality of axial locations of the tubular 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 tubular 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 coupling the tubular member to a distal portion of the elongated core wire; The tapered geometry of at least one of the plurality of transverse cuts comprises a cone angle satisfying the 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 pipe member, and b represents the beam height of the beam adjacent to the at least one transverse cut of the plurality of transverse cuts.

15. The method according to claim 14, 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.

16. The method of claim 14, wherein: The laser is configured to provide beam pulses having a focal angle equal to, or within 5 degrees greater than or less than, a cone angle of the at least one of the plurality of transverse cuts.

17. The method according to claim 14, wherein: The cut width at the inner surface of the tube member is equal to or smaller than 30 micrometers.

18. The method according to claim 14, wherein The cut width at the outer surface of the tube member is equal to or smaller than 47 micrometers.

19. The method according to claim 14, wherein The cut width at the outer surface of the tube member is equal to or smaller than 22 micrometers.

Images