Medical catheter device and preparation method thereof

Abstract

The invention provides a medical catheter device and a preparation method thereof, and belongs to the technical field of medical instruments. The catheter device according to the present invention comprises: a tube member; the tube component comprises a far side part and a near side part; each of the distal portion and the proximal portion of the tube member includes a plurality of cutouts extending circumferentially about a longitudinal axis of the tube member; the plurality of incisions of the distal portion of the tubular member includes a first pitch, a first incision length, and a first non-incision length, the plurality of incisions of the proximal portion of the tubular member includes a second pitch, a second incision length, and a second non-incision length, the first pitch being less than the second pitch, the first incision length being greater than the second incision length, and the second incision length being less than the second incision length. And the first non-cut length is less than the second non-cut length. According to the catheter device, the flexibility, the pushing force, the kink resistance and the dissection adaptability are balanced through gradient incision parameterization design, the catheter device is suitable for complex blood vessel interventional therapy, and the operation safety and the operation efficiency are improved.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 554,138, filed on February 15, 2024, entitled “Medical Device Including Laser Cut Tube,” and priority to U.S. Patent No. 19 / 043,430, filed on February 1, 2025, the disclosures of which are incorporated herein by reference in their entirety. Technical Field

[0003] The present invention relates to the technical field of medical devices, and in particular to a medical catheter device and a preparation method thereof. Background Art

[0004] Catheter devices are widely used in diagnostic and therapeutic medical procedures. Such devices often require a variable stiffness profile, typically with the most flexible section at the distal end, while maintaining good torque transmission for trackability and delivery in tortuous anatomies.

[0005] Catheters typically include a polymer liner, a metal reinforcement layer, and a polymer outer jacket layer. The metal reinforcement layer is the main contributor to catheter stiffness and torque transmission. Traditionally, metal coils or braids are used as catheter reinforcement layers. 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 elements used, micromachining technologies are limited in terms of processing speed, cutting geometry, and the cuttable parameters they can impart to hypotubes.

[0006] Therefore, while advances have been made in the art of catheter devices, there remains a general need for improvements to overcome these and other problems experienced with conventional techniques. It would be desirable to provide a new technique for achieving cutting parameters and geometries on catheter devices that can balance complex bend flexibility, tensile strength, and torque transmission requirements for a variety of medical applications. Summary of the invention

[0007] The present invention provides a medical catheter device and a preparation method thereof, which solves the problem that the current medical catheter device has limited cutting parameters and geometric shapes and is difficult to meet the requirements of bending flexibility, tensile strength and torque transmission.

[0008] In order to solve the above technical problems, the technical solution of the present invention is as follows:

[0009] A catheter device, comprising:

[0010] an elongated liner having a lumen; and

[0011] A tube component disposed on at least one section of the elongated liner, the tube component comprising a distal portion and a proximal portion, the distal portion of the tube component comprising a plurality of cutouts extending circumferentially around a longitudinal axis of the tube component, the proximal portion of the tube component comprising a plurality of cutouts extending circumferentially around the longitudinal axis, wherein

[0012] the plurality of cutouts of the distal portion of the tube member comprising a first spacing, a first cutout length, and a first non-cutout length;

[0013] the plurality of cutouts of the proximal portion of the tube member comprising a second spacing, a second cutout length, and a second non-cutout length; and

[0014] The first spacing is smaller than the second spacing, the first cut length is larger than the second cut length, and the first non-cut length is smaller than the second non-cut length.

[0015] Optionally, a combination of the first incision length and the first non-incision length is greater than or equal to a combination of the second incision length and the second non-incision length.

[0016] Optionally, the plurality of incisions of the distal portion include a first incision width, and the plurality of incisions of the proximal portion include a second incision width that is smaller than the first incision width.

[0017] Optionally, the plurality of incisions in the distal portion are vertical incisions, and the plurality of incisions in the proximal portion are vertical incisions.

[0018] Optionally, the plurality of cuts in the distal portion are vertical cuts, and the plurality of cuts in the proximal portion are spiral cuts.

[0019] Optionally, the plurality of cuts in the distal portion are spiral cuts, and the plurality of cuts in the proximal portion are spiral cuts.

[0020] Optionally, the tube component further comprises a transition portion between the distal portion and the proximal portion, the transition portion of the tube component comprising a plurality of cutouts extending circumferentially around the longitudinal axis of the tube component,

[0021] The plurality of cuts of the transition portion are spiral cuts and include a third pitch, a third cut length, and a third non-cut length.

[0022] Optionally, the third spacing of the plurality of cutouts of the transition portion increases in a proximal direction.

[0023] Optionally, the third interval increases linearly.

[0024] Optionally, the third interval increases nonlinearly.

[0025] Optionally, the third cut length and the third non-cut length of the transition portion are constant.

[0026] Optionally, the third incision length decreases along the proximal direction, and the third non-incision length increases along the proximal direction.

[0027] Optionally, the plurality of cutouts of the transition portion include a third cutout width, and the third cutout width is smaller than the first cutout width of the plurality of cutouts of the distal portion.

[0028] Optionally, the third spacing is constant, the third incision length decreases along the proximal direction, and the third non-incision length increases along the proximal direction.

[0029] Optionally, the tube component further comprises a transition portion between the distal portion and the proximal portion, the transition portion of the tube component comprising a plurality of cutouts extending circumferentially around the longitudinal axis of the tube component,

[0030] wherein said plurality of cutouts of said transition portion are vertical cutouts; and

[0031] The plurality of cutouts of the transition portion include a third spacing that increases in the proximal direction, a third cutout length that decreases in the proximal direction, and a third non-cutout length that increases in the proximal direction.

[0032] Optionally, the distal portion of the tube member extends from the distal end of the tube member to a length of 10 cm or less, and the proximal portion of the tube member extends from a position 25 cm or more from the distal end.

[0033] Optionally, the first spacing of the plurality of cutouts of the distal portion is in the range of 0.07 mm to 0.30 mm, and the second spacing of the plurality of cutouts of the proximal portion is in the range of 0.20 mm to 1.00 mm.

[0034] Optionally, the plurality of cutouts of the distal portion comprise a first cutout width in the range of 0.020 mm to 0.160 mm, and the plurality of cutouts of the proximal portion comprise a second cutout width in the range of 0.020 mm to 0.051 mm.

[0035] Optionally, the first incision length of the multiple incisions of the distal portion is in the range of 60 degrees to 177 degrees, the first non-incision length of the multiple incisions of the distal portion is in the range of 3 degrees to 15 degrees, and wherein the second incision length of the multiple incisions of the proximal portion is in the range of 60 degrees to 165 degrees, and the second non-incision length of the multiple incisions of the proximal portion is in the range of 15 degrees to 40 degrees.

[0036] Optionally, a combination of the first cut length and the first non-cut length is between 75 degrees and 180 degrees, and a combination of the second cut length and the second non-cut length is between 75 degrees and 180 degrees.

[0037] A method for preparing a catheter device, the method being used to prepare the above-mentioned catheter device, comprising:

[0038] Providing an elongated polymer liner;

[0039] providing pipe components;

[0040] forming a plurality of cutouts in the tube member;

[0041] coupling the tube member to an elongated polymer liner;

[0042] A sheath layer is applied to the tubular member to obtain a catheter device.

[0043] The above solution of the present invention includes at least the following beneficial effects:

[0044] The catheter device proposed by the present invention includes: a tube component; the tube component includes a distal portion and a proximal portion; each of the distal portion and the proximal portion of the tube component includes a plurality of cuts extending circumferentially around the longitudinal axis of the tube component; the plurality of cuts of the distal portion of the tube component include a first spacing, a first cut length, and a first non-cut length, and the plurality of cuts of the proximal portion of the tube component include a second spacing, a second cut length, and a second non-cut length, the first spacing is smaller than the second spacing, the first cut length is larger than the second cut length, and the first non-cut length is smaller than the second non-cut length. The catheter device of the present invention achieves a balance between flexibility, pushing force, anti-kinking, and anatomical adaptability through gradient cut parameterized design, is suitable for complex vascular interventional treatment, and improves operational safety and surgical efficiency. BRIEF DESCRIPTION OF THE DRAWINGS

[0045] Figure 1 is a schematic diagram of a section or portion of a catheter device provided by an embodiment of the present invention;

[0046] Figure 2 is a schematic diagram of a section or portion of a tube component provided by an embodiment of the present invention, showing a plurality of vertical cuts;

[0047] Figure 3 is a schematic diagram of a section or portion of a tube component provided by an embodiment of the present invention, showing a plurality of spiral cuts;

[0048] Figure 4 is a schematic diagram of a section or portion of a tube component provided by an embodiment of the present invention, showing a spiral around the outer surface of the tube component and a plurality of cuts following or running along the spiral;

[0049] FIG. 5A to FIG. 5C is a schematic diagram of a spiral path provided by an embodiment of the present invention, wherein a cut may be made on the outer surface of a tube component along the spiral path;

[0050] Figure 6 is a schematic diagram of an exemplary tube component including a plurality of sections or portions having different cut patterns and / or parameters provided by an embodiment of the present invention;

[0051] Figure 7 is a schematic diagram of a section or portion of a tube component provided by an embodiment of the present invention, which shows a plurality of spiral cuts with a constant pitch, a constant cut length, and a constant non-cut length;

[0052] Figure 8 is a schematic diagram of a section or portion of a tube component provided by an embodiment of the present invention, showing a plurality of spiral cuts with increasing pitch, a constant cut length, and a constant non-cut length;

[0053] Fig. 9 is a schematic diagram of a section or portion of a tube component provided by an embodiment of the present invention, showing a plurality of spiral cuts with a constant pitch, a decreasing cut length and an increasing non-cut length;

[0054] Fig.10 is a schematic diagram of a section or portion of a tube component provided by an embodiment of the present invention, showing a plurality of spiral cuts with increasing spacing, decreasing cut length and increasing non-cut length;

[0055] Fig.11 is a schematic diagram of a section or portion of a tube component provided by an embodiment of the present invention, showing a plurality of vertical cuts with increasing spacing, decreasing cut length, and increasing non-cut length;

[0056] Fig.12 is a flow chart of exemplary steps of a method for preparing a catheter device provided by an embodiment of the present invention;

[0057] Among them, 100, catheter device; 102, inner cavity; 104, proximal end; 106, distal end; 110, slender body; 120, lining; 130, outer layer; 140, first tube member; 142, first incision; 200, second tube member; 202, first longitudinal axis; 210, second incision; 300, third tube member; 302, second longitudinal axis; 310, first spiral incision; 311, vertical distance of first spiral incision 310; 312, spiral path; 313, distance between consecutive spiral incisions 310 measured in the vertical direction; 314, outer surface; 315, momentary step switch; 600, fourth tube member; 610, distal portion; 612, third incision; 620, proximal portion; 622, fourth incision; 630, transition portion points; 700, first pipe section; 712, second spiral incision; 800, second pipe section; 812, third spiral incision; 900, third pipe section; 912, fourth spiral incision; 1000, fourth pipe section; 1012, fifth spiral incision; 1100, fifth pipe section; 1112, sixth spiral incision; CL, incision length; CL1, first incision length; CL2, second incision length; CL3, third incision length; UL, non-incision length; UL1, first non-incision length; UL2, second non-incision length; UL3, third non-incision length; P, spacing; P1, first spacing; P2, second spacing; P3, third spacing; CW, incision width; CW1, first incision width; CW2, second incision width; CW3, third incision width; AO, angle offset. DETAILED DESCRIPTION

[0058] Various embodiments of catheter devices and methods of manufacturing catheter devices will now be described with reference to the accompanying drawings. 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 set forth in the accompanying drawings to provide a thorough understanding of the present disclosure. It will be apparent to one of ordinary skill in the art that some of these specific details may not be employed to practice 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.

[0059] Embodiments of the present invention provide a catheter device, which includes a tube component for strengthening and improving the performance of the catheter device. The tube component includes a plurality of cuts, and these cuts have unique cut patterns and / or parameters, such as spacing, cut width, cut length, and non-cut length, etc. These cut patterns and / or parameters can ideally balance the bending flexibility, torsional stiffness, and tensile strength of the catheter device. Embodiments of the present invention also provide a method for manufacturing a catheter device using a laser to achieve new cutting geometries and patterns that cannot be obtained with conventional techniques.

[0060] Figure 1 1 is a cross-sectional view of an exemplary catheter device 100 according to an embodiment of the present invention. The catheter device 100 can be configured to perform a medical procedure, such as a neurointervention, a cardiac intervention, or a peripheral vascular system intervention. In summary, the exemplary catheter device 100 includes an elongated body 110 having an inner cavity 102 extending from a proximal end 104 to a distal end 106. The elongated body 110 can include an inner liner 120, an outer layer 130, and a tube member 140 between the inner liner 120 and the outer layer 130. The inner liner 120 can extend through the entire length of the elongated body 110 defining the inner cavity 102 of the catheter device 100. The inner liner 120 can be made of a lubricating material or a low-friction material to provide a smooth surface for facilitating the passage of a device or object through the inner cavity 102. Suitable lubricating materials include, but are not limited to, polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), and other suitable polymer materials. The polymer material may include additives, such as silicone. The outer layer 130 may include a sheath or sheath to provide mechanical integrity to the catheter device 100. The outer layer 130 may be composed of a material such as a thermoplastic elastomer (TPE), such as polyether block amide, thermoplastic polyurethane, polyethylene, nylon, etc. The outer layer 130 may extend from the proximal end 104 of the elongated body 110 to the distal end 106. The tube member 140 may be combined between the liner 120 and the outer layer 130 and partially or substantially extend the entire length of the elongated body 110. The tube member 140 may be composed of a metal such as stainless steel, nitinol, or a polymer such as polyetheretherketone (PEEK), or any combination thereof. The tube member 140 provides reinforcement for the catheter device 100 to prevent the lumen 112 of the elongated body 110 from kinking or flattening when passing through a tortuous vascular system. According to an embodiment of the present invention, tube member 140 includes a plurality of cutouts 142 having a pattern and geometry that provides a desired balance of bending flexibility, torsional stiffness, and tensile strength for catheter device 100, as will be described in greater detail below.

[0061] Figure 2 Depicted is a portion of an exemplary tube component 200 according to an embodiment of the present invention, which may be used as Figure 1 The tubular component 140 of the catheter device 100 is shown. The portion of the tubular component 200 includes a plurality of cutouts 210 extending circumferentially around the longitudinal axis 202 of the tubular component 200. Figure 2 The plurality of cutouts 210 shown in the drawings are vertical and / or segmented at a plurality of axial locations of the tubular component 200. As used herein, the term "axial location" refers to a location along the longitudinal axis 202 of the tubular component 200. The term "vertical cutout" herein refers to a cutout or slot that extends circumferentially along a path perpendicular to the longitudinal axis 202 of the tubular component 200.

[0062] refer to Figure 2 In describing various embodiments of the present invention, the term "cut length" (CL) may be used to indicate the distance that a vertical cut travels in a circumferential direction. The cut length may be expressed in degrees to normalize for different pipe outer diameters. For example, the cut length may be expressed as X degrees in a 360-degree circumference. The term "uncut length" (UL) may be used to indicate the distance between consecutive or adjacent cuts in a circumferential direction, i.e., from the end of one cut to the beginning of the next cut. Similarly, the uncut length may be expressed in degrees to normalize for different pipe outer diameters, such as X degrees in a 360-degree circumference. According to an embodiment of the present invention, a portion of the second pipe component 200 includes a vertical cut having a longer cut length to increase the flexibility of the pipe component. In some embodiments, a portion of the second pipe component 200 includes a vertical cut with a longer uncut length between consecutive or adjacent cuts to increase stiffness and / or improve the torque response of the pipe component. According to some embodiments of the present invention, in a 360 degree circumference, the combined cut length and non-cut length can add up to a factor of 360 degrees, i.e., 60 degrees, 120 degrees, 180 degrees, etc. For example, if two vertical cuts are provided at a given axial position of a pipe component, the cut length of one vertical cut and the non-cut length between the two vertical cuts can add up to 180 degrees. If three vertical cuts are provided at a given axial position of a pipe component, the cut length of one vertical cut and the non-cut length between the two vertical cuts can add up to 120 degrees.

[0063] refer to Figure 2 In describing various embodiments of the present invention, the term "pitch" (P) may be used to refer to the distance in the axial direction between two adjacent vertical second cuts 210 of the second tube component 200. The pitch can be defined as the distance between the proximal side of one cut and the proximal side of the next adjacent cut in the axial direction. The pitch can also be defined as the distance between the distal side of one cut and the distal side of the next adjacent cut in the axial direction. In some embodiments, a portion of the second tube component 200 includes multiple vertical cuts with a smaller pitch to make the tube component more flexible. In some embodiments, a portion of the second tube component 200 includes multiple vertical cuts with a larger pitch to make the tube component harder and / or increase torque response.

[0064] Still reference Figure 2In describing various embodiments of the present invention, the term "cut width" (CW) may be used to indicate the width of a given cut pattern at the outer surface of the second tube component 200. According to embodiments of the present invention, a portion of the second tube component 200 may include multiple vertical cuts with larger cut widths to make the portion more flexible, or include multiple cuts with smaller cut widths to increase torque response. In describing various embodiments of the present invention, the term "angle offset" (AO) may be used to indicate a cut pattern in which a set of cuts at a given axial position is offset by a set angle from a consecutive set of cuts at the next axial position to avoid non-cut sections being adjacent to each other and stiffening the tube.

[0065] Figure 3 Depicted is a portion of an exemplary third tube component 300 according to other embodiments of the present invention, which may be used as Figure 1 The first tubular component 140 of the catheter device 100 is shown. The portion of the third tubular component 300 includes a plurality of first helical cutouts 310 extending circumferentially around the second longitudinal axis 302 of the third tubular component 300. Figure 3 The plurality of first helical cuts 310 shown in FIG. 3 are spiral or helical about the second longitudinal axis 302 of the third tubular component 300. As used herein, the term "helical cut" refers to a cut or slot extending circumferentially along a helical path about the longitudinal axis of a tubular component. Figure 4 Schematically illustrated is a spiral path 312 on the outer surface 314 of the third tube component 300, and a plurality of first spiral cuts 310 following or running along the spiral path 312. It should be noted that the spiral path 312 can run in a clockwise or counterclockwise direction around the tube. The patterns disclosed herein are independent of the direction of the spiral rotation.

[0066] Reference again Figure 3 In describing various embodiments of the present invention, the term "cut length" (CL) may be used to indicate the distance that a spiral cut travels in the circumferential direction, and this distance is measured in the vertical direction. Figure 3 , reference numeral 310 denotes a spiral cut. Reference numeral 311 indicates the distance in the vertical direction of the first spiral cut 310, and is referred to as the "cut length" of the first spiral cut 310. The cut length may be expressed in degrees to normalize for different tube outer diameters. For example, the cut length 311 of the first spiral cut 310 may be expressed as X degrees out of a 360-degree circle. The term "uncut length" (UL) is used to indicate the distance in the circumferential direction between consecutive or adjacent spiral cuts measured in the vertical direction, i.e., from the end of one cut to the beginning of the next cut. In Figure 3In the figure, reference numeral 313 represents the distance between consecutive first spiral cuts 310 measured in the vertical direction, and is referred to as the "non-cut length". The non-cut length can be expressed in degrees to normalize for different tube outer diameters, such as X degrees in a 360-degree circle. According to an embodiment of the present invention, a portion of the third tube component 300 includes a spiral cut with a longer cut length to increase the flexibility of the tube component. In some embodiments, a portion of the third tube component 300 includes a spiral cut with a longer non-cut length to increase stiffness and / or improve the torque response of the tube component. Due to the spiral nature of the cut pattern, the cut length of the spiral cut and the non-cut length between consecutive spiral cuts do not have to add up to 360 degrees or a factor of 360 degrees, such as 60 degrees, 120 degrees, 180 degrees, etc. In an embodiment of the present invention, the cut length of the spiral cut and the non-cut length between consecutive spiral cuts do not add up to 360 degrees or a factor of 360 degrees to avoid stiffening the tube component by having non-cut segments adjacent to each other. In Figure 2 In the vertical / segmented cut pattern shown, the cuts or groups of cuts may have an angular offset to mitigate the tube stiffening effect.

[0067] refer to Figure 3 In describing various embodiments of the present invention, the term "pitch" (P) is used to represent the distance in the axial direction between adjacent first spiral cuts 310 of the third tube component 300. The pitch can be the distance in the axial direction between the proximal side of one cut and the proximal side of the next cut. The pitch can also be the distance in the axial direction between the distal side of one cut and the distal side of the next cut. In some embodiments, a portion of the tube component includes multiple spiral cuts with a smaller pitch to make the tube component more flexible. In some embodiments, a portion of the tube component includes multiple spiral cuts with a larger pitch to make the tube component harder and increase the torque response.

[0068] According to some embodiments of the present invention, at least a portion of the third tube member 300 may include a plurality of first spiral cuts 310 having a constant pitch, ie, the spiral path or spiral 312 followed by the plurality of cuts has a constant pitch. Figure 5A An exemplary spiral 312 having a constant pitch is schematically shown.

[0069] According to some embodiments of the present invention, at least a portion of the third tube component 300 may include a plurality of first spiral cuts 310 having varying spacing along the length or longitudinal axis of the tube component, such as Figure 5B-5C The varying pitch of the helical cuts can cause the stiffness or flexibility of the tubular component to vary along its length. The pitch can vary linearly along the longitudinal axis of the tubular component, where the pitch increases or decreases by a constant variable, such as Figure 5BIn some embodiments, the varying pitch of the first spiral cutout 310 may include a momentary step switch 315, such as Figure 5C The momentary step switch 315 can indicate a change from a smaller constant pitch to a larger constant pitch, or from a constant pitch to a linearly increasing / decreasing pitch, or from one linearly increasing / decreasing pitch to another linearly increasing / decreasing pitch, etc. Like the pitch, the cut length, non-cut length, and cut width can also be changed linearly or momentarily.

[0070] refer to Figure 6 According to an embodiment of the present invention, an exemplary fourth tube component 600 includes a distal portion 610, a proximal portion 620, and optionally a transition portion 630 between the distal portion 610 and the proximal portion 620. Each of the distal portion 610, the proximal portion 620, and the transition portion 630 includes a plurality of cutouts extending circumferentially around the longitudinal axis of the fourth tube component 600. The pattern and / or parameters of the plurality of cutouts of the distal portion 610, the proximal portion 620, and the transition portion 630 are configured to give the fourth tube component 600 a desired profile, for example, a more flexible distal portion 610, a stiffer proximal portion 620, and a gradual or smooth transition portion 630. The pattern and / or parameters of the plurality of cutouts provide a desired balance between flexibility, torque response, and tensile strength, thereby allowing a catheter device including the fourth tube component 600 to pass through tortuous anatomical structures while also providing support for it to be further advanced into the body.

[0071] refer to Figure 6 , the distal portion 610 may include a plurality of third incisions 612 having a first incision length CL1, a first non-incision length UL1, a first incision width CW1, and a first spacing P1. Each of CL1, UL1, CW1, and P1 may be a constant value, or vary linearly on the distal portion 610, or include an instantaneous change. The proximal portion 620 may include a plurality of fourth incisions 622 having a second incision length CL2, a second non-incision length UL2, a second incision width CW2, and a second spacing P2. Each of CL2, UL2, CW2, and P2 may be a constant value, or vary linearly on the proximal portion 620, or include an instantaneous change. The transition portion 630 may include a plurality of incisions ( Figure 6 Each of CL3, UL3, CW3, and P3 may be a constant value, or vary linearly over the transition portion 630, or include instantaneous changes.

[0072] According to an embodiment of the present invention, the first spacing of the third incisions 612 of the distal portion 610 is smaller than the second spacing of the fourth incisions 622 of the proximal portion 620. In one embodiment, the first incision length of the third incision 612 of the distal portion 610 is greater than the second incision length of the fourth incision 622 of the proximal portion 620. In one embodiment, the first non-incision length of the third incision 612 of the distal portion 610 is smaller than the second non-incision length of the fourth incision 622 of the proximal portion 620. In one embodiment, the first spacing of the third incision 612 of the distal portion 610 is smaller than the second spacing of the fourth incision 622 of the proximal portion 620, the first incision length of the third incision 612 of the distal portion 610 is greater than the second length of the fourth incision 622 of the proximal portion 620, and the first non-incision length of the third incision 612 of the distal portion 610 is smaller than the second non-incision length of the fourth incision 622 of the proximal portion 620.

[0073] According to an embodiment of the present invention, the combined first incision length and the first non-incision length are greater than or equal to the combined second incision length and the second non-incision length.

[0074] According to an embodiment of the present invention, the plurality of third incisions 612 of the distal portion 610 have a first incision width CW1, the plurality of fourth incisions 622 of the proximal portion 620 have a second incision width CW2, and the first incision width is greater than the second incision width. Alternatively, the first incision width of the third incisions 612 of the distal portion 610 is substantially the same as the second incision width of the fourth incisions 622 of the proximal portion 620.

[0075] According to an embodiment of the present invention, the plurality of third cuts 612 of the distal portion 610 include vertical cuts, and the plurality of fourth cuts 622 of the proximal portion 620 include spiral cuts. Alternatively, the plurality of third cuts 612 of the distal portion 610 and the plurality of fourth cuts 622 of the proximal portion 620 are both spiral cuts. In some embodiments, the plurality of third cuts 612 of the distal portion 610 and the plurality of fourth cuts 622 of the proximal portion 620 are both vertical cuts. Typically, a vertical cut pattern allows for smaller spacing and greater cut lengths.

[0076] For example, the fourth tube member 600 according to an embodiment of the present invention includes a distal portion 610 extending from the distal end of the tube member for a length of 10 cm or less, and a proximal portion 620 extending from an axial position of 25 cm or more from the distal end. Each of the distal portion 610 and the proximal portion 620 of the fourth tube member 600 includes a plurality of spiral cuts. In the distal portion 610 of the fourth tube member 600, the pitch of the plurality of third cuts 612 is in the range of 0.07 mm to 0.30 mm, the cut width is in the range of 0.0008 inches to 0.0060 inches (0.020 mm to 0.160 mm), the non-cut length is in the range of 3 degrees to 15 degrees, the cut length is in the range of 60 degrees to 177 degrees, and the combined cut length and non-cut length are in the range of 75 degrees to 180 degrees. In the proximal portion 620 of the fourth tube component 600, the plurality of fourth slits 622 have a pitch in the range of 0.30 mm to 1.00 mm, a slit width in the range of 0.0008 inches to 0.0020 inches (0.020 mm to 0.051 mm), a non-slit length in the range of 15 degrees to 40 degrees, a slit length in the range of 60 degrees to 165 degrees, and a combined slit length and non-slit length in the range of 75 degrees to 180 degrees.

[0077] It should be noted that the above specific dimensions, sizes and degrees are provided for a thorough understanding of the present invention. The claims and the scope of the present invention are not limited to the specific dimensions, sizes and degrees.

[0078] In conjunction with each of the above embodiments, the optional transition portion 630 of the fourth tube component 600 includes a plurality of cuts having a cut pattern and / or parameters configured to facilitate a smooth or gradual transition from the more flexible distal portion 610 to the more rigid proximal portion 620 .

[0079] Figure 7 An exemplary first pipe segment 700 is depicted, which may be used as a transition portion 630 of the fourth pipe component 600, according to an embodiment of the present invention. Figure 7As shown, the first tube segment 700 includes a plurality of second spiral cuts 712. The plurality of second spiral cuts 712 have a constant third pitch P3, a constant third cut length CL3, and a constant third non-cut length UL3. In one embodiment, the third pitch P3 of the second spiral cuts 712 of the first tube segment 700 is greater than or equal to the first pitch P1 of the third cuts 612 of the distal portion 610 of the fourth tube component 600. Alternatively, the third pitch P3 of the second spiral cuts 712 of the first tube segment 700 is less than or equal to the second pitch P2 of the fourth cuts 622 of the proximal portion 620 of the fourth tube component 600. The third cut length CL3 of the second spiral cuts 712 of the first tube segment 700 may be less than or equal to the first cut length CL1 of the third cuts 612 of the distal portion 610 of the fourth tube component 600. Alternatively, the third cut length CL3 of the second spiral cut 712 of the first tube segment 700 may be greater than or equal to the second cut length CL2 of the fourth cut 622 of the proximal portion 620 of the fourth tube component 600. The third non-cut length UL3 of the second spiral cut 712 of the first tube segment 700 may be greater than or equal to the first non-cut length UL1 of the third cut 612 of the distal portion 610 of the fourth tube component 600, and / or less than or equal to the third non-cut length UL3 of the fourth cut 622 of the proximal portion 620 of the fourth tube component 600. The combined third cut length CL3 and third non-cut length UL3 of the cut 712 of the first tube segment 700 may be less than or equal to 180 degrees.

[0080] Figure 8 Another exemplary second pipe segment 800 is depicted, which may be used as the transition portion 630 of the fourth pipe component 600, according to an embodiment of the present invention. Figure 8As shown, the second tube segment 800 includes a plurality of third spiral cuts 812. The plurality of third spiral cuts 812 have a proximally increasing pitch (P3, P3+Δ), a constant third cut length CL3, and a constant third non-cut length UL3, Δ being an increment. The pitch (P3, P3+Δ) of the third spiral cuts 812 of the second tube segment 800 may be greater than the first pitch P1 of the third cuts 612 of the distal portion 610 of the fourth tube component 600, and increase in the proximal direction. The pitch (P3, P3+Δ) of the third spiral cuts 812 of the second tube segment 800 may increase linearly along the longitudinal axis of the second tube segment 800, or increase nonlinearly along the longitudinal axis of the second tube segment 800, for example, including an instantaneous pitch change. While increasing proximally, the pitch (P3, P3+Δ) of the third spiral cuts 812 of the second tube segment 800 may be less than the second pitch P2 of the fourth cuts 622 of the proximal portion 620 of the fourth tube component 600. The third cut length CL3 of the third spiral cut 812 of the second tube segment 800 may be less than or equal to the first cut length CL1 of the third cut 612 of the distal portion 610 of the fourth tube component 600, and / or greater than or equal to the second cut length CL2 of the fourth cut 622 of the proximal portion 620 of the fourth tube component 600. The third non-cut length UL3 of the third spiral cut 812 of the second tube segment 800 may be greater than or equal to the first non-cut length UL1 of the third cut 612 of the distal portion 610 of the fourth tube component 600, and / or less than or equal to the second non-cut length UL2 of the fourth cut 622 of the proximal portion 620 of the fourth tube component 600. The combined third cut length CL3 and third non-cut length UL3 of the cut 812 of the second tube segment 800 may be less than or equal to 180 degrees.

[0081] Fig. 9 Another exemplary third pipe segment 900 is depicted, which may be used as a transition portion 630 of the fourth pipe component 600, according to an embodiment of the present invention. Fig. 9As shown, the third tube segment 900 includes a plurality of fourth spiral cuts 912. The plurality of fourth spiral cuts 912 have a constant third pitch P3, a cut length (CL3, CL3-Δ) that decreases proximally, and a non-cut length (UL3, UL3+Δ) that increases proximally. The constant third pitch P3 of the fourth spiral cuts 912 of the third tube segment 900 may be greater than or equal to the first pitch P1 of the third cuts 612 of the distal portion 610 of the fourth tube component 600, and / or less than or equal to the second pitch P2 of the fourth cuts 622 of the proximal portion 620 of the fourth tube component 600. The cut length (CL3, CL3-Δ) of the fourth spiral cuts 912 of the third tube segment 900 may be less than the first cut length CL1 of the third cuts 612 of the distal portion 610 of the fourth tube component 600, and decrease linearly or nonlinearly in the proximal direction, for example, including an instantaneous change. While decreasing proximally, the cut length (CL3, CL3-Δ) of the fourth helical cut 912 of the third tube segment 900 may be greater than the second cut length CL2 of the fourth cut 622 of the proximal portion 620 of the fourth tube component 600. The non-cut length (UL3, UL3+Δ) of the fourth helical cut 912 of the third tube segment 900 may be greater than the first non-cut length UL1 of the third cut 612 of the distal portion 610 of the fourth tube component 600, and increase linearly or non-linearly in the proximal direction, for example, including an instantaneous change. While increasing proximally, the non-cut length (UL3, UL3+Δ) of the fourth helical cut 912 of the third tube segment 900 may be less than the second non-cut length UL2 of the fourth cut 622 of the proximal portion 620 of the fourth tube component 600. The combined third cut length CL3 and the third non-cut length UL3 of the fourth helical cut 912 of the third tube segment 900 may be less than or equal to 180 degrees.

[0082] Fig.10 A fourth pipe segment 1000 is depicted, which may be used as a transition portion 630 of a fourth pipe component 600, according to an embodiment of the present invention. Fig.10As shown, the fourth tube segment 1000 includes a plurality of fifth spiral cuts 1012. The plurality of fifth spiral cuts 1012 have a proximally increasing pitch (P3, P3+Δ), a proximally decreasing cut length (CL3, CL3-Δ), and a proximally increasing non-cut length (UL3, UL3+Δ). The pitch (P3, P3+Δ) of the fifth spiral cuts 1012 of the fourth tube segment 1000 may be greater than the first pitch P1 of the third cuts 612 of the distal portion 610 of the fourth tube component 600, and increase in the proximal direction. The proximally increasing pitch (P3, P3+Δ) may increase linearly or nonlinearly along the longitudinal axis of the fourth tube segment 1000. While increasing proximally, the pitch (P3, P3+Δ) of the fifth spiral cuts 1012 of the fourth tube segment 1000 may be less than the second pitch P2 of the fourth cuts 622 of the proximal portion 620 of the fourth tube component 600. The cut length (CL3, CL3-Δ) of the fifth spiral cut 1012 of the fourth tube segment 1000 may be less than the first cut length CL1 of the third cut 612 of the distal portion 610 of the fourth tube component 600, and decrease linearly or nonlinearly in the proximal direction. While decreasing proximally, the cut length (CL3, CL3-Δ) of the fifth spiral cut 1012 of the fourth tube segment 1000 may be greater than the second cut length CL2 of the fourth cut 622 of the proximal portion 620 of the fourth tube component 600. The non-cut length (UL3, UL3+Δ) of the fifth spiral cut 1012 of the fourth tube segment 1000 may be greater than the first non-cut length UL1 of the third cut 612 of the distal portion 610 of the fourth tube component 600, and increase linearly or nonlinearly in the proximal direction. While increasing proximally, the non-cut length (UL3, UL3+Δ) of the fifth spiral cut 1012 of the fourth tube segment 1000 may be less than the second non-cut length UL2 of the fourth cut 622 of the proximal portion 620 of the fourth tube component 600. The combined third cut length CL3 and the third non-cut length UL3 of the fifth spiral cut 1012 of the fourth tube segment 1000 may be less than or equal to 180 degrees.

[0083] Fig.11 A fifth pipe segment 1100 is depicted, which may be used as a transition portion 630 of the fourth pipe component 600, according to an embodiment of the present invention. Fig.11As shown, the fifth tube segment 1100 includes a plurality of sixth spiral cuts 1112 segmented at a plurality of axial positions of the fifth tube segment 1100. The plurality of sixth spiral cuts 1112 of the fifth tube segment 1100 define a proximally increasing pitch (P3, P3+Δ), a proximally decreasing cut length (CL3, CL3-Δ), and a proximally increasing non-cut length (UL3, UL3+Δ). The pitch (P3, P3+Δ) of the sixth spiral cuts 1112 of the fifth tube segment 1100 may be greater than the first pitch P1 of the third cuts 612 of the distal portion 610 of the fourth tube component 600, and increase linearly or non-linearly in the proximal direction. While increasing proximally, the pitch (P3, P3+Δ) of the sixth spiral cuts 1112 of the fifth tube segment 1100 may be less than the second pitch P2 of the fourth cuts 622 of the proximal portion 620 of the fourth tube component 600. The cut length (CL3, CL3-Δ) of the sixth spiral cut 1112 of the fifth tube segment 1100 may be less than the first cut length CL1 of the third cut 612 of the distal portion 610 of the fourth tube component 600, and decrease linearly or nonlinearly in the proximal direction. While decreasing proximally, the cut length (CL3, CL3-Δ) of the sixth spiral cut 1112 of the fifth tube segment 1100 may be greater than the second cut length CL2 of the fourth cut 622 of the proximal portion 620 of the fourth tube component 600. The non-cut length (UL3, UL3+Δ) of the sixth spiral cut 1112 of the fifth tube segment 1100 may be greater than the first non-cut length UL1 of the third cut 612 of the distal portion 610 of the fourth tube component 600, and increase linearly or nonlinearly in the proximal direction. While increasing proximally, the non-cut length (UL3, UL3+Δ) of the sixth spiral cut 1112 of the fourth tube segment 1000 may be less than the second non-cut length UL2 of the fourth cut 622 of the proximal portion 620 of the fourth tube component 600. The combined cut length (CL3, CL3-Δ) and non-cut length (UL3, UL3+Δ) of the sixth spiral cut 1112 of the fourth tube segment 1000 may be a factor of 360 degrees, i.e., 60 degrees, 120 degrees, 180 degrees, etc.

[0084] It should be noted that although the transition portion of the combined pipe component (e.g. Figure 6 The transition portion 630 of the fourth tube member 600 is shown to describe Figure 7-9 The first pipe segment 700, the second pipe segment 800, the third pipe segment 900 and the fourth pipe segment 1000 are shown in the embodiment, but the above-mentioned incision pattern and parameters and Figure 7-9 The cut patterns and parameters shown may be used in the distal portion, the proximal portion, or the entire length of a tube component included in a catheter device or other medical device.

[0085] Embodiments of the present invention provide a method for manufacturing a catheter device. The method utilizes laser cutting of a tube component to obtain patterns and / or geometries that are not obtainable by conventional techniques. The novel cutting patterns and / or geometries provide the catheter device with a desired balance between bending flexibility, torsional stiffness, and tensile strength. Beneficially, the laser cutting techniques described herein allow for more precise control over the design input, for example, by providing a wide range of kerf widths by, for example, adjusting the width of the laser beam. With conventional micromachining, the kerf width must be equal to the width of a cutting element such as a physical saw.

[0086] Fig.12 1 is a flowchart of exemplary steps of a method 1200 for manufacturing a catheter device according to an embodiment of the present invention. The method is described in conjunction with an embodiment of manufacturing a catheter device. In step 1201, an elongated polymer liner is provided. The polymer liner can be composed of a biocompatible lubricating or low-friction material to provide a smooth surface for a device or object to pass through the lumen. Suitable lubricating materials include, but are not limited to, polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), polyether block amide (PEBA) and other suitable polymer materials. The polymer material may include additives such as siloxane. The polymer liner can be a single continuous tubular member extending substantially over the entire axial length of the catheter device. The polymer liner can also be a multi-piece or multi-region structure, in which each piece or region is made of different materials having different properties (e.g., flexibility or rigidity). For example, the proximal section or region of the polymer liner can be made of a relatively rigid material to obtain better pushability and torsionability, while the distal section of the polymer liner can be made of a relatively more elastic material to obtain better maneuverability and traceability. The polymer liner can be constructed by extrusion or any other suitable method.

[0087] The polymer liner can have a length sufficient to reach the target site in the patient's body. Typically, the length of the polymer liner ranges between 40 cm and 160 cm. The distal section of the polymer liner can taper toward the distal end to provide greater bending flexibility. The proximal section of the polymer liner can have an increased diameter to maintain the pushability and torsional rigidity of the catheter device. Depending on the application, the polymer liner can have an inner diameter of 0.012 inches to 0.3 inches and a wall thickness of 0.00025 inches to 0.0030 inches. In one embodiment, a catheter device with an outer diameter greater than 0.125 inches can be manufactured according to the method 1200 of the present invention.

[0088] In step 1202, a tube component is provided. The tube component can be made of a metal, a metal alloy, a polymer, a metal-polymer composite material, or any combination thereof. Suitable metals and metal alloys for the tube component 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 tube component include polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), polyether ether ketone (PEEK) and other suitable polymer materials.

[0089] The tube member may have a length that covers at least a portion of the length of the polymer liner. In some embodiments, the tube member may have a length that covers the entire length of the polymer liner. For example, the tube member may have a length of, for example, 40 cm to 160 cm to be applied to a catheter device.

[0090] The tubular component may have an outer diameter, an inner diameter, and a wall thickness that are selected to provide one or more desired base properties for a particular application, such as stiffness, flexibility, tensile strength, torque response, etc. In general, if the outer diameter of the tubular component is increased and the wall thickness is decreased, the tubular component may have the same bending stiffness and increased torque response at the expense of some mechanical strength. In another example, if the outer diameter of the tube is decreased and the wall thickness is increased, the tubular component may have increased axial stiffness with the same bending stiffness at the expense of reduced torque response.

[0091] In step 1203, a plurality of cuts or slots are formed in the tube component. The plurality of cuts formed in the tube component extend circumferentially around the longitudinal axis of the tube component with pre-designed cut lengths, widths, spacings and other parameters. The plurality of cuts may be vertical cuts extending circumferentially along paths each perpendicular to the longitudinal axis of the tube component. The plurality of cuts may also be spiral cuts extending along a spiral path around the longitudinal axis of the tube component.

[0092] According to embodiments of the present invention, a laser is used to form a plurality of cuts or slots in a tube component. A laser beam or pulse can cut or remove material from a thin tubular part or tube component with high accuracy and resolution without mechanical deformation or burrs. According to embodiments of the present invention, laser pulses are used to form patterns and / or geometric shapes of micron or sub-micron dimensions. The laser cutting process can be automated or configured with computer software for efficient high-speed processing.

[0093] Various types of lasers are available in the art and can be selected for use in the method of manufacturing the guide wire device of the present invention. According to an embodiment of the present invention, a gas-assisted laser is used to cut a tube component, wherein a pressurized gas jet or assisting gas is used to blow away molten material, cool the material and prevent it from warping or re-solidifying to improve the quality and efficiency of the cutting process.

[0094] The duration, frequency, shape and other parameters of the laser pulses may be set or selected based on the cut size, geometry and cutting speed, etc. If the tube component is thin, a high pulse frequency and a short pulse duration may be used. The pulse duration is the time elapsed between the start and end of a single pulse of energy, measured in seconds. The shorter the pulse duration, the greater the effectiveness of the cut, with fewer burrs or defects (e.g., heat affected zones). Ultrashort pulses ranging from tens of picoseconds to femtoseconds may be used in embodiments of the present invention.

[0095] The stage can be used to hold and / or move the tube component during the cutting process. The stage can be controlled by a precision motor system that can horizontally translate and / or rotate the tube component with micron or sub-micron precision. For example, during the cutting process, the tube component can be held and / or moved by the stage while the beam pulses from the laser source are aimed and deposited on the tube component. In some embodiments, the laser source includes a series of optical devices that can be controlled and / or adjusted during the cutting process while the tube component is held and / or moved by the stage.

[0096] In one 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 the desired cut length (measured in degrees) is achieved, the laser source can be turned off.

[0097] In one embodiment, the tube member is held at a first axial position. As the tube member rotates at the first axial position, pulses of the laser beam may be deposited to the tube member. A first vertical cut is formed at the first axial position of the tube member. The tube member is then translated to a second axial position. As the tube member rotates at the second axial position, pulses of the laser beam may be deposited to the tube member. A second vertical cut is formed at the second axial position of the tube member. In this manner, multiple vertical cuts may be formed at multiple axial positions in the tube member.

[0098] In one embodiment, the tube member is translated from a first axial position to a second axial position and rotated during the translation. Pulses of the laser beam can be deposited onto the tube member while the tube member is simultaneously translated and rotated. In this manner, 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.

[0099] In step 1204, the tubular component is coupled to the elongated polymer liner. The polymer liner can be inserted into the interior of the tubular component and securely bonded to the tubular component using a suitable bonding means.

[0100] In step 1205, a jacket layer may be applied to the pipe component-polymer liner assembly, such as by coating. Suitable materials for the jacket layer include, but are not limited to, thermoplastic elastomers (TPEs), such as polyether block amides, thermoplastic polyurethanes, polyethylene, nylon, and the like.

[0101] Various embodiments of catheter devices and methods of manufacturing catheter 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 and can be practiced in any other embodiment. The accompanying drawings are intended to illustrate the embodiments rather than to describe in detail or to limit the scope of the invention. Without departing from the principles of the claimed invention, alternative structures, components and materials will be easily considered feasible. In addition, although some embodiments of the present invention are described in conjunction with catheter devices, this is not intended to be restrictive. For example, a tube component including multiple vertical and / or spiral cuts can be constructed as a component for a guidewire device and other intervascular devices. As an example, a guidewire device can include an elongated core wire and a tube component as described herein, which is arranged on a distal section of the core wire.

[0102] Unless otherwise specifically 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 of "a", "an" and "the" include plural references unless the context clearly dictates otherwise. Unless the context clearly dictates otherwise, the term "or" refers to a non-exclusive "or". The term "proximal" and its grammatical equivalents refer to a position, direction or orientation toward the user or physician's side. The term "distal" and its grammatical equivalents refer to a position, direction or orientation away from the user or physician's side. The names "backward", "forward", etc. do not mean that the referenced components are limited to a specific orientation. It should be understood that such names refer to the orientation of the referenced components shown in the drawings; the systems and devices of the present invention can be used in any orientation suitable for the user. The terms "first" or "second" and the like can be used to distinguish one element from another when describing various similar elements. It should be noted that the terms "first" and "second" used herein include references to two or more than two. In addition, the use of the terms "first" or "second" should not be interpreted as in any particular order unless the context clearly dictates otherwise. In alternative embodiments, the order in which the method steps are performed can be changed. One or more method steps can be skipped entirely, and one or more optional steps can 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 value, e.g., having the same function or result. The term "about" may include numbers rounded to the nearest significant figure. Numerical ranges expressed by endpoints include all numbers within the range.

[0103] 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 invention.

Claims

1. A catheter device, characterized in that: include: an elongated liner having a lumen; and A tube component disposed on at least one section of the elongated liner, the tube component comprising a distal portion and a proximal portion, the distal portion of the tube component comprising a plurality of cutouts extending circumferentially around a longitudinal axis of the tube component, the proximal portion of the tube component comprising a plurality of cutouts extending circumferentially around the longitudinal axis, wherein the plurality of cutouts of the distal portion of the tube member comprising a first spacing, a first cutout length, and a first non-cutout length; the plurality of cutouts of the proximal portion of the tube member comprising a second spacing, a second cutout length, and a second non-cutout length; and The first spacing is smaller than the second spacing, the first cut length is larger than the second cut length, and the first non-cut length is smaller than the second non-cut length.

2. The catheter device according to claim 1, characterized in that A combination of the first slit length and the first non-slit length is greater than or equal to a combination of the second slit length and the second non-slit length.

3. The catheter device according to claim 1, characterized in that The plurality of cutouts of the distal portion include a first cutout width, and the plurality of cutouts of the proximal portion include a second cutout width that is smaller than the first cutout width.

4. The catheter device according to claim 1, characterized in that The plurality of cuts of the distal portion are vertical cuts, and the plurality of cuts of the proximal portion are vertical cuts.

5. The catheter device according to claim 1, characterized in that The plurality of cuts of the distal portion are vertical cuts, and the plurality of cuts of the proximal portion are spiral cuts.

6. The catheter device according to claim 1, characterized in that The plurality of cuts of the distal portion are spiral cuts, and the plurality of cuts of the proximal portion are spiral cuts.

7. The catheter device according to claim 1, characterized in that The tube component further includes a transition portion between the distal portion and the proximal portion, the transition portion of the tube component including a plurality of cutouts extending circumferentially around a longitudinal axis of the tube component, The plurality of cuts of the transition portion are spiral cuts and include a third pitch, a third cut length, and a third non-cut length.

8. The catheter device according to claim 7, characterized in that The third spacing of the plurality of cutouts of the transition portion increases in a proximal direction.

9. The catheter device according to claim 8, characterized in that The third interval increases linearly.

10. The catheter device according to claim 8, characterized in that The third spacing increases non-linearly.

11. The catheter device according to claim 8, characterized in that The third cut length and the third non-cut length of the transition portion are constant.

12. The catheter device according to claim 8, characterized in that The third incision length decreases along the proximal direction, and the third non-incision length increases along the proximal direction.

13. The catheter device according to claim 7, characterized in that The plurality of cutouts of the transition portion include a third cutout width, and the third cutout width is less than the first cutout width of the plurality of cutouts of the distal portion.

14. The catheter device according to claim 7, characterized in that The third spacing is constant, the third slit length decreases in a proximal direction, and the third non-slit length increases in the proximal direction.

15. The catheter device according to claim 1, characterized in that The tube component further includes a transition portion between the distal portion and the proximal portion, the transition portion of the tube component including a plurality of cutouts extending circumferentially around a longitudinal axis of the tube component, wherein said plurality of cutouts of said transition portion are vertical cutouts; and The plurality of cutouts of the transition portion include a third spacing that increases in the proximal direction, a third cutout length that decreases in the proximal direction, and a third non-cutout length that increases in the proximal direction.

16. The catheter device according to claim 1, characterized in that The distal portion of the tube member extends from a distal end of the tube member to a length of 10 cm or less, and the proximal portion of the tube member extends from a position 25 cm or more from the distal end.

17. The catheter device according to claim 16, characterized in that The first pitch of the plurality of cutouts of the distal portion is in a range of 0.07 mm to 0.30 mm, and the second pitch of the plurality of cutouts of the proximal portion is in a range of 0.20 mm to 1.00 mm.

18. The catheter device according to claim 17, characterized in that The plurality of cutouts of the distal portion include a first cutout width in a range of 0.020 mm to 0.160 mm, and the plurality of cutouts of the proximal portion include a second cutout width in a range of 0.020 mm to 0.051 mm.

19. The catheter device according to claim 18, characterized in that The first incision length of the multiple incisions of the distal portion is in the range of 60 degrees to 177 degrees, the first non-incision length of the multiple incisions of the distal portion is in the range of 3 degrees to 15 degrees, and wherein the second incision length of the multiple incisions of the proximal portion is in the range of 60 degrees to 165 degrees, and the second non-incision length of the multiple incisions of the proximal portion is in the range of 15 degrees to 40 degrees.

20. The catheter device of claim 19, wherein: A combination of the first slit length and the first non-slit length is between 75 degrees and 180 degrees, and a combination of the second slit length and the second non-slit length is between 75 degrees and 180 degrees.

21. A method for preparing a catheter device, characterized in that: The method is used to prepare a catheter device according to any one of claims 1 to 20, comprising: Providing an elongated polymer liner; providing pipe components; forming a plurality of cutouts in the tube member; coupling the tube member to an elongated polymer liner; A sheath layer is applied to the tubular member to obtain a catheter device.

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