Intravascular medical device comprising laser cutting tube
By designing incisions with unique cutting parameters on the tube components of the intravascular device and using laser cutting technology, the problem of difficult to balance the bending flexibility, tensile strength and torque transmission requirements in the prior art is solved, and a more flexible and effective intravascular device design is achieved.
Patent Information
- Application Number
- CN202510164537.X
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2025-02-01
- Filing Date
- 2025-02-14
- Publication Date
- 2025-05-30
AI Technical Summary
Existing intravascular devices have limitations in realizing cutting parameters and geometry, making it difficult to balance complex bending flexibility, tensile strength and torque transmission requirements.
An intravascular device is designed, with a tube member including a distal and proximal portion, each of which has unique parameters such as pitch, cutting length, uncut length and cutting width, and these complex cutting patterns and geometries are achieved by laser cutting technology.
With this design, the intravascular device can achieve a balance of flexibility and rigidity while maintaining good torque transmission, adapting to various complex vascular anatomical structures.
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Figure CN120053855A_ABST
Abstract
Description
Technical Field
[0001] This application generally relates to medical devices and methods of making and using medical devices to treat diseases. Specifically, various embodiments of intravascular devices and methods of making the same are described. Background Art
[0002] Intravascular devices such as catheters and guidewires are widely used in clinical procedures for diagnosis and treatment. Such devices often require a variable stiffness profile, typically having the most flexible section at the distal end while maintaining good torque transmission to achieve trackability and delivery in tortuous anatomies.
[0003] For example, a catheter typically includes a polymer liner, a metal reinforcement layer, and a polymer outer jacket layer. The metal reinforcement layer is the main contributor to the stiffness and torque transmission of the catheter. Traditionally, metal coils or braids have been used as catheter reinforcement layers. As microfabrication techniques have gradually evolved, microfabricated hypotubes have also entered the field as device components. However, due to the size and shape of the cutting elements used, microfabrication techniques are limited in terms of the processing speed, cutting geometry, and cuttable parameters that can be applied to hypotubes.
[0004] Thus, while progress has been made in the field of intravascular devices, there is still an overall need for improvement to overcome these and other problems experienced by traditional techniques. There is a desire to provide a new technique for achieving cutting parameters and geometries on intravascular devices that can balance complex bending flexibility, tensile strength, and torque transmission requirements for various medical application scenarios. Summary of the Invention
[0005] In one aspect, embodiments of the present disclosure feature an intravascular device. Generally, embodiments of the intravascular device include a tube member that includes a distal portion and a proximal portion. Each of the distal portion and the proximal portion of the tube member includes a plurality of incisions that extend circumferentially around a longitudinal axis of the tube member. The plurality of incisions in the distal portion of the tube member include a first pitch, a first cut length, and a first uncut length, the plurality of incisions in the proximal portion of the tube member include a second pitch, a second cut length, and a second uncut length, and the first pitch is less than the second pitch, the first cut length is greater than the second cut length, and the first uncut length is less than the second uncut length.
[0006] In various embodiments of the aspect, the plurality of incisions in the distal portion include a first cut width, and the plurality of incisions in the proximal portion include a second cut width that is less than the first cut width.
[0007] In various embodiments of the aspect, each of the first pitch, the first cut length, the first uncut length, and the first cut width includes a constant value. In various embodiments of the aspect, each of the first pitch, the first cut length, the first uncut length, and the first cut width varies linearly along the distal portion or includes an instantaneous change.
[0008] In various embodiments of the aspect, each of the second pitch, the second cut length, the second uncut length, and the second cut width includes a constant value. In various embodiments of the aspect, each of the second pitch, the second cut length, the second uncut length, and the second cut width varies linearly along the proximal portion or includes an instantaneous change.
[0009] In various embodiments of the aspect, the combination of the first cut length and the first uncut length is greater than or equal to the combination of the second cut length and the second uncut length.
[0010] In various embodiments of the aspect, the plurality of incisions in the distal portion are vertical incisions, and the plurality of incisions in the proximal portion are vertical incisions.
[0011] In various embodiments of the aspect, the plurality of incisions in the distal portion are vertical incisions, and the plurality of incisions in the proximal portion are helical incisions.
[0012] In various embodiments of the aspect, the plurality of incisions in the distal portion are helical incisions, and the plurality of incisions in the proximal portion are helical incisions.
[0013] In various embodiments of the aspects, the tube member further includes a transition portion located between the distal portion and the proximal portion. The transition portion of the tube member includes a plurality of incisions extending circumferentially around the longitudinal axis of the tube member. The plurality of incisions of the transition portion are helical incisions and include a third pitch, a third cut length, and a third uncut length. In an embodiment, the third pitch of the plurality of incisions of the transition portion increases in the proximal direction. The third pitch can increase linearly or non-linearly, for example, including an instantaneous change. In an embodiment, the third cut length and the third uncut length of the transition portion are constant. In an embodiment, the third cut length decreases in the proximal direction, and the third uncut length increases in the proximal direction. The third cut length and the third uncut length can also vary linearly or non-linearly, including an instantaneous change. In an embodiment, the plurality of incisions of the transition portion include a third cut width that is less than or equal to the first cut width of the plurality of incisions of the distal portion. In an embodiment, the third pitch is constant, the third cut length decreases in the proximal direction, and the third uncut length increases in the proximal direction. In an embodiment, each of the third pitch, the third cut length, and the third uncut length of the transition portion is constant.
[0014] In various embodiments of the aspects, the tube member further includes a transition portion located between the distal portion and the proximal portion. The transition portion of the tube member includes a plurality of incisions extending circumferentially around the longitudinal axis of the tube member. The plurality of incisions of the transition portion are vertical incisions and include a third pitch that increases in the proximal direction, a third cut length that decreases in the proximal direction, and a third uncut length that increases in the proximal direction.
[0015] In various embodiments of the aspect, the distal portion of the tube member extends a length of 10 cm or less from the distal end of the tube member, and the proximal portion of the tube member extends from a position 15 cm or more away from the distal end. In an embodiment, the first pitch of the plurality of incisions of the distal portion is in the range from 0.03 mm to 0.30 mm, and the second pitch of the plurality of incisions of the proximal portion is in the range from 0.10 mm to 1.00 mm. In an embodiment, the plurality of incisions of the distal portion include a first cut width ranging from 0.020 mm to 0.160 mm, and the plurality of incisions of the proximal portion include a second cut width ranging from 0.020 mm to 0.051 mm. In an embodiment, the first cut length of the plurality of incisions of the distal portion is in the range from 60 degrees to 177 degrees, the first uncut length of the plurality of incisions of the distal portion is in the range from 3 degrees to 15 degrees, the second cut length of the plurality of incisions of the proximal portion is in the range from 60 degrees to 165 degrees, and the second uncut length of the plurality of incisions of the proximal portion is in the range from 15 degrees to 40 degrees. In an embodiment, the combination of the first cut length and the first uncut length is from 75 degrees to 180 degrees, and the combination of the second cut length and the second uncut length is from 75 degrees to 180 degrees.
[0016] In various embodiments of the aspect, the intravascular device includes a catheter, the catheter including an elongate inner lining having a lumen and the above-described tube member surrounding at least the distal portion of the elongate inner lining.
[0017] In various embodiments of the aspect, the intravascular device includes a guide wire, the guide wire including an elongate core wire and the above-described tube member surrounding at least the distal portion of the elongate core wire.
[0018] In another aspect, embodiments of the present disclosure are characterized by a tube member for use in a medical device. The tube member includes a distal portion and a proximal portion. Each of the distal portion and the proximal portion of the tube member includes a plurality of incisions extending circumferentially around the longitudinal axis of the tube member. The plurality of incisions of the distal portion of the tube member include a first pitch, a first cut length, and a first uncut length, the plurality of incisions of the proximal portion of the tube member include a second pitch, a second cut length, and a second uncut length, and the first pitch is less than the second pitch, the first cut length is greater than the second cut length, and the first uncut length is less than the second uncut length.
[0019] In various embodiments of the aspect, the plurality of incisions of the distal portion include a first cutting width, and the plurality of incisions of the proximal portion include a second cutting width that is less than the first cutting width.
[0020] In various embodiments of the aspect, each of the first pitch, the first cutting length, the first uncut length, and the first cutting width includes a constant value. In various embodiments of the aspect, each of the first pitch, the first cutting length, the first uncut length, and the first cutting width linearly varies along the distal portion or includes an instantaneous change.
[0021] In various embodiments of the aspect, each of the second pitch, the second cutting length, the second uncut length, and the second cutting width includes a constant value. In various embodiments of the aspect, each of the second pitch, the second cutting length, the second uncut length, and the second cutting width linearly varies along the proximal portion or includes an instantaneous change.
[0022] In various embodiments of the aspect, the combination of the first cutting length and the first uncut length is greater than or equal to the combination of the second cutting length and the second uncut length.
[0023] In various embodiments of the aspect, the plurality of incisions of the distal portion are vertical incisions, and the plurality of incisions of the proximal portion are vertical incisions.
[0024] In various embodiments of the aspect, the plurality of incisions of the distal portion are vertical incisions, and the plurality of incisions of the proximal portion are helical incisions.
[0025] In various embodiments of the aspect, the plurality of incisions of the distal portion are helical incisions, and the plurality of incisions of the proximal portion are helical incisions.
[0026] In various embodiments of the aspects described above, the tube member further includes a transition portion located between the distal portion and the proximal portion. The transition portion of the tube member includes a plurality of incisions extending circumferentially around the longitudinal axis of the tube member. The plurality of incisions in the transition portion are helical incisions and include a third pitch, a third cut length, and a third uncut length. In an embodiment, the third pitch of the plurality of incisions in the transition portion increases in the proximal direction. The third pitch can increase linearly or non-linearly. In an embodiment, the third cut length and the third uncut length of the transition portion are constant. In an embodiment, the third cut length decreases in the proximal direction and the third uncut length increases in the proximal direction. The third cut length and the third uncut length can also vary linearly or non-linearly, including an instantaneous change. In an embodiment, the plurality of incisions in the transition portion include a third cut width that is less than or equal to the first cut width of the plurality of incisions in the distal portion. In an embodiment, the third pitch is constant, the third cut length decreases in the proximal direction, and the third uncut length increases in the proximal direction. In an embodiment, each of the third pitch, the third cut length, and the third uncut length of the transition portion is constant.
[0027] In various embodiments of the aspects described above, the tube member further includes a transition portion located between the distal portion and the proximal portion. The transition portion of the tube member includes a plurality of incisions extending circumferentially around the longitudinal axis of the tube member. The plurality of incisions in the transition portion are perpendicular incisions and include a third pitch that increases in the proximal direction, a third cut length that decreases in the proximal direction, and a third uncut length that increases in the proximal direction.
[0028] This summary is provided to introduce a selected aspect and embodiments of the present disclosure in a simplified form and is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to assist in determining the scope of the claimed subject matter. The selected aspect and embodiments are merely presented to provide a summary of certain forms the present invention may take and are not intended to limit the scope of the present invention. Other aspects and embodiments of the present disclosure are described in the detailed description section.
[0029] These and various other aspects, embodiments, features, and advantages of the present disclosure will be better understood after reading the following detailed description in conjunction with the accompanying drawings. Brief Description of the Drawings
[0030] Figure 1 is a simplified illustration of a segment or portion of an exemplary tubular intravascular device in accordance with an embodiment of the present disclosure.
[0031] Figure 2 is a simplified illustration of a section or portion of an exemplary tube member showing multiple vertical cuts in accordance with an embodiment of the present disclosure.
[0032] Figure 3 is a simplified illustration of a section or portion of an exemplary tube member showing multiple helical cuts in accordance with an embodiment of the present disclosure.
[0033] Figure 4 is a simplified illustration of a section or portion of an exemplary tube member showing a helix around the outer surface of the tube member and multiple cuts following or traveling along the helix.
[0034] Figures 5A to 5C is a simplified illustration showing an exemplary helical path along which cuts can be created on the outer surface of a tube member in accordance with an embodiment of the present disclosure.
[0035] Figure 6 is a simplified illustration of an exemplary tube member including multiple segments or portions having different cutting patterns and / or parameters in accordance with an embodiment of the present disclosure.
[0036] Figure 7 is a simplified illustration of a section or portion of an exemplary tube member showing multiple helical cuts having a constant pitch, a constant cut length, and a constant uncut length in accordance with an embodiment of the present disclosure.
[0037] Figure 8 is a simplified illustration of a section or portion of an exemplary tube member showing multiple helical cuts having an increasing pitch, a constant cut length, and a constant uncut length in accordance with an embodiment of the present disclosure.
[0038] Figure 9 is a simplified illustration of a section or portion of an exemplary tube member showing multiple helical cuts having a constant pitch, a decreasing cut length, and an increasing uncut length in accordance with an embodiment of the present disclosure.
[0039] Figure 10 is a simplified illustration of a section or portion of an exemplary tube member showing multiple helical cuts having an increasing pitch, a decreasing cut length, and an increasing uncut length in accordance with an embodiment of the present disclosure.
[0040] Figure 11 is a simplified illustration of a section or portion of an exemplary tube member showing multiple vertical cuts having an increasing pitch, a decreasing cut length, and an increasing uncut length in accordance with an embodiment of the present disclosure.
[0041] Figure 12 is a flow chart illustrating exemplary steps of a method of manufacturing an intravascular device in accordance with an embodiment of the present disclosure. Detailed Description
[0042] Referring to the various figures, various embodiments of an intravascular device and a method of manufacturing an intravascular device will now be described. The figures 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 figures to provide a thorough understanding of the embodiments 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 employed to practice the embodiments of the present disclosure. In other instances, structures, components, systems, materials, and / or operations that are often associated with known medical procedures may not be shown or described in detail so as not to unnecessarily obscure the description of the embodiments of the present disclosure.
[0043] Embodiments of the present disclosure provide an intravascular device that includes a tube member for strengthening and improving the performance of the intravascular device. The tube member includes a plurality of incisions having a unique cutting pattern and / or parameters such as pitch, cut width, cut length, and uncut length, which can balance the bending flexibility, torsional rigidity, and tensile strength of the intravascular device as desired. Embodiments of the present disclosure also provide a method of manufacturing an intravascular device using a laser to achieve new incision geometries and patterns that are difficult to obtain with conventional techniques.
[0044] Figure 1An exemplary endovascular device 100 in accordance with an embodiment of the present disclosure is illustrated in cross-section. The endovascular device 100 can be configured for performing clinical procedures such as neurological, cardiovascular, or peripheral vascular interventions. Generally speaking, the exemplary endovascular device 100 includes an elongate body 110 having a lumen 102 extending from a proximal end 104 to a distal end 106. The elongate body 110 can include an inner liner 120, an outer layer 130, and a tube member 140 located between the inner liner 120 and the outer layer 130. The inner liner 120 can extend through the entire length of the elongate body 110 that defines the lumen 102 of the endovascular device 100. The inner liner 120 can be composed of a lubricious or low-friction material to provide a smooth surface for advancing a device or object through the lumen 102. Suitable lubricious materials include, but are not limited to, polytetrafluoroethylene (PTFE), fluorinated ethylene propylene copolymer (FEP), siloxanes, and other suitable polymeric materials. The polymeric materials can include additives such as siloxanes. The outer layer 130 can include a jacket or sheath to provide mechanical integrity to the endovascular device 100. The outer layer 130 can be composed of a material such as a thermoplastic elastomer (TPE) (e.g., polyether block amide, thermoplastic polyurethane, polyethylene, nylon, etc.). The outer layer 130 can extend from the proximal end 104 to the distal end 106 of the elongate body 110. The tube member 140 can be incorporated between the inner liner 120 and the outer layer 130 and extend partially or substantially the entire length along the elongate body 110. The tube member 140 can 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 to the endovascular device 100 to prevent the inner lumen 102 of the elongate body 110 from kinking or flattening when navigating through tortuous vasculature. In accordance with an embodiment of the present disclosure, the tube member 140 includes a plurality of incisions 142 having patterns and geometries that will be described in more detail below, which provide a desired balance of bending flexibility, torsional rigidity, and tensile strength to the endovascular device 100.
[0045] Figure 2 A portion of an exemplary tube member 200 in accordance with an embodiment of the present disclosure is depicted, and the exemplary tube member 200 can be used as Figure 1 the tube member 140 of the endovascular device 100 shown. A portion of the tube member 200 includes a plurality of incisions 210 that circumferentially extend around a longitudinal axis 202 of the tube member 200. Figure 2 The plurality of incisions 210 shown are perpendicular and / or segmented at a plurality of axial positions of the tube member 200. As used herein, the term "axial position" refers to a position along the longitudinal axis 202 of the tube member 200. The term "perpendicular incision" can be used herein to refer to an incision or slot that circumferentially extends along a path orthogonal to the longitudinal axis 202 of the tube member 200.
[0046] ReferenceFigure 2 In describing various embodiments of the present disclosure, the term "cut length" (CL) may be used to indicate the distance that a vertical cut travels in the circumferential direction. The cut length can be expressed in degrees to standardize for different tube outer diameters. For example, the cut length can be expressed as X degrees in a 360-degree circumference. The term "uncut length" (UL) may be used to indicate the distance between sequential or adjacent cuts in the circumferential direction, i.e., the distance from the end of one cut to the start of the next cut. Similarly, the uncut length can be expressed in degrees to standardize for different tube outer diameters, e.g., X degrees in a 360-degree circumference. According to an embodiment of the present disclosure, a portion of the tube member 200 includes vertical cuts having a longer cut length to increase the flexibility of the tube member. In some embodiments, a portion of the tube member 200 includes vertical cuts having a longer uncut length between sequential or adjacent cuts to increase the stiffness of the tube member and / or improve the torque response of the tube member. According to some embodiments of the present disclosure, the combined cut length and uncut length in a 360 circumference can total a factor of 360 degrees, i.e., 60 degrees, 120 degrees, 180 degrees, etc. As an example, if two vertical cuts are provided at a given axial position of the tube member, the cut length of the vertical cuts and the uncut length between the two vertical cuts can total 180 degrees. If three vertical cuts are provided at a given axial position of the tube member, the cut length of the cuts and the uncut length between two of the vertical cuts can total 120 degrees.
[0047] Reference Figure 2 In describing various embodiments of the present disclosure, the term "pitch" (P) may be used to indicate the distance between two adjacent vertical cuts 210 of the tube member 200 in the axial direction. The pitch can be defined as the distance in the axial direction between the proximal side of one cut and the proximal side of the next adjacent cut. The pitch can also be defined as the distance in the axial direction between the distal side of one cut and the distal side of the next adjacent cut. In some embodiments, a portion of the tube member 200 includes a plurality of vertical cuts having a relatively small pitch to make the tube member more flexible. In some embodiments, a portion of the tube member 200 includes a plurality of vertical cuts having a relatively large pitch to make the tube member stiffer and / or improve the torque response.
[0048] Still referring Figure 2, when describing various embodiments of the present disclosure, the term "cutting width" (CW) may be used to refer to the width of a given cutting pattern at the outer surface of the tube member 200. According to an embodiment of the present disclosure, a portion of the tube member 200 may include a plurality of vertical incisions having a larger cutting width to make the portion more flexible, or may include a plurality of incisions having a smaller cutting width to improve torque response. When describing various embodiments of the present disclosure, the term "angular offset" (AO) may be used to indicate a cutting pattern in which a set of incisions at a given axial position is offset by a set angle from a set of incisions at the next successive axial position to avoid stiffening of the tube due to positioning uncut segments adjacent to each other.
[0049] Figure 3 Depicts a portion of an exemplary tube member 300 according to an alternative embodiment of the present disclosure, which exemplary tube member 300 can be used as Figure 1 the tube member 140 of the intravascular device 100 shown. A portion of the tube member 300 includes a plurality of incisions 310 that circumferentially extend around the longitudinal axis 302 of the tube member 300. Figure 3 The plurality of incisions 310 shown are coiled or helical around the longitudinal axis 302 of the tube member 300. As used herein, the term "helical incision" refers to an incision or groove that circumferentially extends along a path that spirals around the longitudinal axis of the tube. Figure 4 Schematically shows a helical path 312 on the outer surface 314 of the tube member 300 and a plurality of incisions 310 that follow or travel along the helical path 312. It should be noted that the helix 312 can travel around the tube in a clockwise or counterclockwise direction. The patterns disclosed herein are independent of the direction of helical rotation.
[0050] Returning to Figure 3 , when describing various embodiments of the present disclosure, the term "cutting length" (CL) may be used to indicate the distance that a helical incision travels in the circumferential direction as measured in the vertical direction. In Figure 3 , reference numeral 310 indicates the helical incision. Reference numeral 311 indicates the distance of the helical incision 310 in the vertical direction and is referred to as the "cutting length" of the helical incision 310. The cutting length can be expressed in degrees to standardize for different tube outer diameters. For example, the cutting length 311 of the helical incision 310 can be expressed as X degrees in a 360-degree circumference. The term "uncut length" (UL) is used to indicate the distance in the circumferential direction between sequential or adjacent helical incisions as measured in the vertical direction, i.e., the distance from the end of one incision to the start of the next incision. In Figure 3In this case, reference numeral 313 indicates the distance between sequential helical cuts 310 measured in the vertical direction and is referred to as the "uncut length". The uncut length can be expressed in degrees to standardize for different tube outer diameters, e.g., X degrees out of 360 degrees of circumference. According to embodiments of the present disclosure, a portion of the tube member 300 includes helical cuts with a relatively long cut length to increase the flexibility of the tube member. In some embodiments, a portion of the tube member 300 includes helical cuts with a relatively long uncut length to increase the stiffness of the tube member and / or improve the torque response of the tube member. Due to the helical nature of the cut pattern, the cut length of the helical cuts and the uncut length between sequential helical cuts need not add up to 360 degrees or a factor of 360 degrees, such as 60 degrees, 120 degrees, 180 degrees, etc. In embodiments of the present disclosure, the cut length of the helical cuts and the uncut length between sequential helical cuts do not add up to 360 degrees or a factor of 360 degrees to avoid the effect of stiffening the tube member by positioning uncut segments adjacent to each other. In Figure 2 the vertical / segmented cut pattern shown, the cuts or groups of cuts can have an angular offset to mitigate the tube stiffening effect.
[0051] Reference Figure 3 , in describing various embodiments of the present disclosure, the term "pitch" (P) is used to indicate the distance between adjacent helical cuts 310 of the tube member 300 in the axial direction. 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 member includes a plurality of helical cuts with a relatively small pitch to make the tube member more flexible. In some embodiments, a portion of the tube member includes a plurality of helical cuts with a relatively large pitch to make the tube member stiffer and improve the torque response.
[0052] According to some embodiments of the present disclosure, at least a portion of the tube member 300 can include a plurality of helical cuts 310 with a constant pitch, i.e., the helical path or helix 312 followed by the plurality of cuts has a constant pitch. Figure 5A An example helix 312 with a constant pitch is schematically shown.
[0053] According to some embodiments of the present disclosure, as Figure 5B and Figure 5C shown, at least a portion of the tube member 300 can include a plurality of helical cuts 310 with a varying pitch along the length or longitudinal axis of the tube member. The varying pitch of the helical cuts can result in a varying stiffness or flexibility of the tube member along the length of the tube member. As Figure 5BAs shown, the pitch can vary linearly along the longitudinal axis of the tube member, where the pitch increases or decreases at a constant variable. In some embodiments, as Figure 5C shown, the varying pitch of the helical cut 310 can include an instantaneous step or switch 315. The pitch step or switch 315 can indicate a change from a smaller constant pitch to a larger constant pitch, or a change from a constant pitch to a linearly increasing / decreasing pitch, or a change from a linearly increasing / decreasing pitch to another linearly increasing / decreasing pitch, etc. In the same manner that the pitch can vary in these many ways, the cut length, the uncut length, and the cut width can also vary linearly or change instantaneously.
[0054] Referring Figure 6 to, according to an embodiment of the present disclosure, an exemplary tube member 600 includes a distal portion 610, a proximal portion 620, and optionally a transition portion 630 located 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 incisions that circumferentially extend around the longitudinal axis of the tube member 600. The pattern and / or parameters of the plurality of incisions of the distal portion 610, the proximal portion 620, and the transition portion 630 are configured to impart a desired profile to the tube member 600, e.g., 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 incisions provide a desired balance between flexibility, torque response, and tensile strength, such that an intravascular device including the tube member 600 can navigate tortuous anatomy while also giving it support to be further advanced into the body.
[0055] Referring Figure 6 to, the distal portion 610 can include a plurality of incisions 612 having a first cut length (CL1), a first uncut length (UL1), a first cut width (CW1), and a first pitch (P1). Each of CL1, UL1, CW1, and P1 can be a constant value or vary linearly throughout the distal portion 610 or include an instantaneous change. The proximal portion 620 can include a plurality of incisions 622 having a second cut length (CL2), a second uncut length (UL2), a second cut width (CW2), and a second pitch (P2). Each of CL2, UL2, CW2, and P2 can be a constant value or vary linearly throughout the proximal portion 620 or include an instantaneous change. The transition portion 630 can include a plurality of incisions (not shown in Figure 6 ) having a third cut length (CL3), a third uncut length (UL3), a third cut width (CW3), and a third pitch (P3). Each of CL3, UL3, CW3, and P3 can be a constant value or vary linearly throughout the transition portion 630 or include an instantaneous change.
[0056] According to an embodiment of the present disclosure, a first pitch of the incision 612 of the distal portion 610 is less than a second pitch of the incision 622 of the proximal portion 620. In an embodiment, a first cutting length of the incision 612 of the distal portion 610 is greater than a second cutting length of the incision 622 of the proximal portion 620. In an embodiment, a first uncut length of the incision 612 of the distal portion 610 is less than a second uncut length of the incision 622 of the proximal portion 620. In an embodiment, a first pitch of the incision 612 of the distal portion 610 is less than a second pitch of the incision 622 of the proximal portion 620, a first cutting length of the incision 612 of the distal portion 610 is greater than a second length of the incision 622 of the proximal portion 620, and a first uncut length of the incision 612 of the distal portion 610 is less than a second uncut length of the incision 622 of the proximal portion 620.
[0057] According to an embodiment of the present disclosure, a combined first cutting length and first uncut length is greater than or equal to a combined second cutting length and second uncut length.
[0058] According to an embodiment of the present disclosure, a plurality of incisions 612 of the distal portion 610 have a first cutting width (CW1), a plurality of incisions 622 of the proximal portion 620 have a second cutting width (CW2), and the first cutting width is greater than the second cutting width. Alternatively, the first cutting width of the incision 612 of the distal portion 610 is substantially the same as the second cutting width of the incision 622 of the proximal portion 620.
[0059] According to an embodiment of the present disclosure, a plurality of incisions 612 of the distal portion 610 include vertical incisions, and a plurality of incisions 622 of the proximal portion 620 include helical incisions. Alternatively, a plurality of incisions 612 of the distal portion 610 and a plurality of incisions 622 of the proximal portion 620 are both helical incisions. In some embodiments, a plurality of incisions 612 of the distal portion 610 and a plurality of incisions 622 of the proximal portion 620 are both vertical incisions. Generally speaking, a vertical cutting pattern allows for a smaller pitch and a larger cutting length.
[0060] As an example, a tube member 600 according to an embodiment of the present disclosure includes a distal portion 610 having a length extending 10 cm or less from the distal end of the tube member and a proximal portion 620 extending from an axial position 15 cm or more from the distal end. Each of the distal portion 610 and the proximal portion 620 of the tube member 600 includes a plurality of helical cuts. In the distal portion 610 of the tube member 600, the plurality of helical cuts 612 have a pitch ranging from 0.03 mm to 0.30 mm, a cut width ranging from 0.0008 inches to 0.0060 inches (0.020 mm to 0.160 mm), an uncut length ranging from 3 degrees to 15 degrees, a cut length ranging from 60 degrees to 177 degrees, and a combined cut length and uncut length ranging from 75 degrees to 180 degrees. In the proximal portion 620 of the tube member 600, the plurality of helical cuts 622 have a pitch ranging from 0.10 mm to 1.00 mm, a cut width ranging from 0.0008 inches to 0.0020 inches (0.020 mm to 0.051 mm), an uncut length ranging from 15 degrees to 40 degrees, a cut length ranging from 60 degrees to 165 degrees, and a combined cut length and uncut length ranging from 75 degrees to 180 degrees.
[0061] It should be noted that the above specific dimensions, sizes, and degrees are provided for a thorough understanding of the present disclosure. The scope of the claims and the disclosure is not limited to the specific dimensions, sizes, and degrees.
[0062] In combination with each of the above embodiments, an optional transition portion 630 of the tube member 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 stiffer proximal portion 620.
[0063] Figure 7Depicts an example pipe segment 700 according to an embodiment of the present disclosure, which can be used as a transition portion 630 of the pipe member 600. As shown, the pipe segment 700 includes a plurality of helical cuts 712. The plurality of helical cuts 712 have a constant pitch (P3), a constant cut length (CL3), and a constant uncut length (UL3). In an embodiment, the pitch (P3) of the helical cuts 712 of the pipe segment 700 is greater than or equal to the pitch (P1) of the cuts 612 of the distal portion 610 of the pipe member 600. Alternatively or additionally, the pitch (P3) of the helical cuts 712 of the pipe segment 700 is less than or equal to the pitch (P2) of the cuts 622 of the proximal portion 620 of the pipe member 600. The cut length (CL3) of the helical cuts 712 of the pipe segment 700 may be less than or equal to the cut length (CL1) of the cuts 612 of the distal portion 610 of the pipe member 600. Alternatively or additionally, the cut length (CL3) of the helical cuts 712 of the pipe segment 700 may be greater than or equal to the cut length (CL2) of the cuts 622 of the proximal portion 620 of the pipe member 600. The uncut length (UL3) of the helical cuts 712 of the pipe segment 700 may be greater than or equal to the uncut length (UL1) of the cuts 612 of the distal portion 610 of the pipe member 600, and / or less than or equal to the uncut length (UL3) of the cuts 622 of the proximal portion 620 of the pipe member 600. The combined cut length (CL3) and uncut length (UL3) of the cuts 712 of the pipe segment 700 may be less than or equal to 180 degrees.
[0064] Figure 8Depicts another exemplary pipe segment 800 according to an embodiment of the present disclosure, which can be used as a transition portion 630 of the pipe member 600. As shown, the pipe segment 800 includes a plurality of helical cuts 812. The plurality of helical cuts 812 have a proximally increasing pitch (P3, P3 + Δ), a constant cut length (CL3), and a constant uncut length (UL3). The pitch (P3, P3 + Δ) of the helical cuts 812 of the pipe segment 800 can be greater than the pitch (P1) of the cuts 612 of the distal portion 610 of the pipe member 600 and increases in the proximal direction. The pitch (P3, P3 + Δ) of the helical cuts 812 of the pipe segment 800 can increase linearly along the longitudinal axis of the pipe segment 800 or non-linearly along the longitudinal axis of the pipe segment 800, for example, including an instantaneous pitch switch. When increasing proximally, the pitch (P3 or P3 + Δ) of the helical cuts 812 of the pipe segment 800 can be less than the pitch (P2) of the cuts 622 of the proximal portion 620 of the pipe member 600. The cut length (CL3) of the helical cuts 812 of the pipe segment 800 can be less than or equal to the cut length (CL1) of the cuts 612 of the distal portion 610 of the pipe member 600, and / or greater than or equal to the cut length (CL2) of the cuts 622 of the proximal portion 620 of the pipe member 600. The uncut length (UL3) of the helical cuts 812 of the pipe segment 800 can be greater than or equal to the uncut length (UL1) of the cuts 612 of the distal portion 610 of the pipe member 600, and / or less than or equal to the uncut length (UL2) of the cuts 622 of the proximal portion 620 of the pipe member 600. The combined cut length (CL3) and uncut length (UL3) of the cuts 812 of the pipe segment 800 can be less than or equal to 180 degrees.
[0065] Figure 9Depicts another exemplary pipe section 900 according to an embodiment of the present disclosure, which can be used as the transition portion 630 of the pipe member 600. As shown, the pipe section 900 includes a plurality of helical cuts 912. The plurality of helical cuts 912 have a constant pitch (P3), a proximally decreasing cut length (CL3, CL3-Δ), and a proximally increasing uncut length (UL3, UL3+Δ). The constant pitch (P3) of the helical cuts 912 of the pipe section 900 can be greater than or equal to the pitch (P1) of the cuts 612 of the distal portion 610 of the pipe member 600, and / or less than or equal to the pitch (P2) of the cuts 622 of the proximal portion 620 of the pipe member 600. The cut length (CL3, CL3-Δ) of the helical cuts 912 of the pipe section 900 can be less than the cut length (CL1) of the cuts 612 of the distal portion 610 of the pipe member 600, and decreases linearly or non-linearly in the proximal direction, for example, including an instantaneous switch. When decreasing proximally, the cut length (CL3, CL3-Δ) of the helical cuts 912 of the pipe section 900 can be greater than the cut length (CL2) of the cuts 622 of the proximal portion 620 of the pipe member 600. The uncut length (UL3, UL3+Δ) of the helical cuts 912 of the pipe section 900 can be greater than the uncut length (UL1) of the cuts 612 of the distal portion 610 of the pipe member 600, and increases linearly or non-linearly in the proximal direction, for example, including an instantaneous change. When increasing proximally, the uncut length (UL3, UL3+Δ) of the helical cuts 912 of the pipe section 900 can be less than the uncut length (UL2) of the cuts 622 of the proximal portion 620 of the pipe member 600. The combined cut length (CL3) and uncut length (UL3) of the helical cuts 912 of the pipe section 900 can be less than or equal to 180 degrees.
[0066] Figure 10Depicts another pipe section 1000 according to an embodiment of the present disclosure, which can be used as a transition portion 630 of the pipe member 600. As shown, the pipe section 1000 includes a plurality of helical cuts 1012. The plurality of helical cuts 1012 have a proximally increasing pitch (P3, P3+Δ), a proximally decreasing cut length (CL3, CL3-Δ), and a proximally increasing uncut length (UL3, UL3+Δ). The pitch (P3, P3+Δ) of the helical cuts 1012 of the pipe section 1000 can be greater than the pitch (P1) of the cuts 612 of the distal portion 610 of the pipe member 600 and increases in the proximal direction. The proximally increasing pitch (P3, P3+Δ) can increase linearly or non-linearly along the longitudinal axis of the pipe section 1000. While increasing proximally, the pitch (P3, P3+Δ) of the helical cuts 1012 of the pipe section 1000 can be less than the pitch (P2) of the cuts 622 of the proximal portion 620 of the pipe member 600. The cut length (CL3, CL3-Δ) of the helical cuts 1012 of the pipe section 1000 can be less than the cut length (CL1) of the cuts 612 of the distal portion 610 of the pipe member 600 and decreases linearly or non-linearly in the proximal direction. While decreasing proximally, the cut length (CL3, CL3-Δ) of the helical cuts 1012 of the pipe section 1000 can be greater than the cut length (CL2) of the cuts 622 of the proximal portion 620 of the pipe member 600. The uncut length (UL3, UL3+Δ) of the helical cuts 1012 of the pipe section 1000 can be greater than the uncut length (UL1) of the cuts 612 of the distal portion 610 of the pipe member 600 and increases linearly or non-linearly in the proximal direction. While increasing proximally, the uncut length (UL3, UL3+Δ) of the helical cuts 1012 of the pipe section 1000 can be less than the uncut length (UL2) of the cuts 622 of the proximal portion 620 of the pipe member 600. The combined cut length (CL3) and uncut length (UL3) of the helical cuts 1012 of the pipe section 1000 can be less than or equal to 180 degrees.
[0067] Figure 11Depicts another pipe segment 1100 according to an embodiment of the present disclosure, which can be used as a transition portion 630 of the pipe member 600. As shown, the pipe segment 1100 includes a plurality of vertical cuts 1112 segmented at a plurality of axial positions of the pipe segment 1100. The plurality of vertical cuts 1112 of the pipe segment 1100 define a proximal increasing pitch (P3, P3+Δ), a proximal decreasing cut length (CL3, CL3-Δ), and a proximal increasing uncut length (UL3, UL3+Δ). The pitch (P3, P3+Δ) of the helical cuts 1112 of the pipe segment 1100 can be greater than the pitch (P1) of the cuts 612 of the distal portion 610 of the pipe member 600 and increase linearly or non-linearly in the proximal direction. When increasing proximally, the pitch (P3, P3+Δ) of the helical cuts 1112 of the pipe segment 1100 can be less than the pitch (P2) of the cuts 622 of the proximal portion 620 of the pipe member 600. The cut length (CL3, CL3-Δ) of the helical cuts 1112 of the pipe segment 1100 can be less than the cut length (CL1) of the cuts 612 of the distal portion 610 of the pipe member 600 and decrease linearly or non-linearly in the proximal direction. When decreasing proximally, the cut length (CL3, CL3-Δ) of the helical cuts 1112 of the pipe segment 1100 can be greater than the cut length (CL2) of the cuts 622 of the proximal portion 620 of the pipe member 600. The uncut length (UL3, UL3+Δ) of the helical cuts 1112 of the pipe segment 1100 can be greater than the uncut length (UL1) of the cuts 612 of the distal portion 610 of the pipe member 600 and increase linearly or non-linearly in the proximal direction. When increasing proximally, the uncut length (UL3, UL3+Δ) of the helical cuts 1112 of the pipe segment 1100 can be less than the uncut length (UL2) of the cuts 622 of the proximal portion 620 of the pipe member 600. The combined cut length (CL3, CL3-Δ) and uncut length (UL3, UL3+Δ) of the helical cuts 1112 of the pipe segment 1100 can be a factor of 360 degrees, i.e., 60 degrees, 120 degrees, 180 degrees, etc.
[0068] It should be noted that although the embodiments of the pipe segments 700, 800, 900, and 1000 depicted in Figure 6 are described in relation to a transition portion of a pipe member (such as Figures 7 to 9 the transition portion 630 of the pipe member 600 shown), the cutting patterns and parameters described above and shown in Figures 7 to 9 can be used in the distal portion, proximal portion, or the entire length of a pipe member to be included in an intravascular device or other medical device.
[0069] Embodiments of the present disclosure provide a method of manufacturing an intravascular device. The method uses a laser to cut a tube member in patterns and / or geometries that are difficult to obtain by conventional techniques. The novel cutting patterns and / or geometries provide a desired balance between bending flexibility, torsional rigidity, and tensile strength to the intravascular device. Advantageously, the laser cutting techniques described herein allow for more precise control of design inputs, e.g., by adjusting the width of the laser beam to provide a wide range of cut widths. In conventional microfabrication, the cut width must be equal to the width of a cutting element such as a physical saw.
[0070] Figure 12 FIG. illustrates example steps of a method 1200 of manufacturing an intravascular device in accordance with an embodiment of the present disclosure. The method is described in the context of an embodiment of manufacturing a catheter device. It should be noted that the steps of the method 1200 can be implemented to manufacture other intravascular devices such as guidewires. At step 1202, an elongate polymeric liner is provided. The polymeric liner can be composed of a biocompatible lubricious or low-friction material to provide a smooth surface for advancing a device or object through an inner lumen. Suitable lubricious materials include, but are not limited to, polytetrafluoroethylene (PTFE), fluorinated ethylene propylene copolymer (FEP), polyether block amide (PEBA), and other suitable polymeric materials. The polymeric material can include additives such as siloxanes. The polymeric liner can be a single continuous tube member that extends substantially along the entire axial length of the catheter device. The polymeric liner can also be a multi-piece or multi-region configuration, where each piece or region is made of a different material having different properties such as flexibility or rigidity. For example, the proximal section or region of the polymeric liner can be made of a relatively rigid material to obtain better pushability and torsionality, whereas the distal section of the polymeric liner can be made of a relatively more elastic material to obtain better maneuverability and trackability. The polymeric liner can be constructed by extrusion or any other suitable method.
[0071] The polymeric liner can have a length sufficient to reach a target site within a patient. Generally, the length of the polymeric liner ranges from 5 cm to 300 cm. The distal section of the polymeric liner can be tapered towards the distal end to provide greater bending flexibility. The proximal section of the polymeric liner can have an increased diameter to maintain the pushability and torsional rigidity of the catheter device. Depending on the application, the polymeric liner can have an inner diameter ranging from 0.012 inches to 0.115 inches and a wall thickness ranging from 0.00025 inches to 0.0030 inches. In an embodiment, a catheter device having an outer diameter equal to or less than 0.125 inches can be manufactured in accordance with the method 1200 of the present disclosure.
[0072] In step 1204, a tube member is provided. The tube member can be made of metal, metal alloy, polymer, metal-polymer composite, or any combination thereof. Suitable metals and metal alloys for the tube member include stainless steel, nitinol or nickel-titanium alloy, 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 member include polytetrafluoroethylene (PTFE), fluorinated ethylene propylene copolymer (FEP), polyetheretherketone (PEEK), and other suitable polymer materials.
[0073] The length of the tube member can cover at least a portion of the polymer lining. In some embodiments, the length of the tube member can cover the entire length of the polymer lining. As an example, the tube member can have a length in the range of, for example, 5 cm to 300 cm for use in a catheter device. It should be noted that the embodiments of the present disclosure can be applied when manufacturing other medical devices such as a guide wire device, which has a length suitable for use as a guide wire device.
[0074] The tube member can have an outer diameter, an inner diameter, and a wall thickness that are selected to provide one or more desired base properties such as rigidity, flexibility, tensile strength, torque response, etc. for a particular application. Generally speaking, if the outer diameter of the tube member increases while the wall thickness decreases, the tube member can have the same bending stiffness with an improved torque response at the cost of a certain mechanical strength. In another example, if the outer diameter of the tube member decreases while the wall thickness increases, the tube member can have an increased axial stiffness with the same bending stiffness at the cost of a reduced torque response.
[0075] In step 1206, a plurality of incisions or slots are formed in the tube member. The plurality of incisions formed in the tube member extend circumferentially around the longitudinal axis of the tube member with pre-designed cutting lengths, widths, pitches, and other parameters. The plurality of incisions can be vertical incisions that extend circumferentially along a path that is perpendicular to the longitudinal axis of the tube member. The plurality of incisions can also be helical incisions that extend along a helical path around the longitudinal axis of the tube member.
[0076] According to an embodiment of the present disclosure, a laser is used to form a plurality of incisions or slots in the tube member. The laser beam or pulse can cut or remove material from a thin tubular portion or tube member with high precision and high resolution without generating mechanical deformation or burrs. According to an embodiment of the present disclosure, micron or sub-micron sized patterns and / or geometries are formed using laser pulses. The laser cutting process can be automated or configured using computer software to achieve efficient high-speed machining.
[0077] In the art, various types of lasers are available and various types of lasers can be selected for use in the method of manufacturing the guide wire device of the present disclosure. According to an embodiment of the present disclosure, a gas-assisted laser is used for cutting the tube member, wherein a pressurized gas jet or assist gas is utilized to blow away the molten material, cool the material, and prevent the material from warping or re-solidifying to improve the quality and efficiency of the cutting process.
[0078] The duration, frequency, shape, and other parameters of the laser pulse can be set or selected based on the cut size, geometry, cutting speed, etc. If the tube member is thin, a high pulse frequency and short pulse duration can be used. The pulse duration is the time elapsed between the start and end of a single energy pulse measured in seconds. The shorter the pulse duration, the greater the effectiveness of the cutting and the fewer burrs or defects (such as the heat-affected zone). Ultrashort pulses ranging from a few tens of picoseconds to several femtoseconds can be used in the embodiments of the present disclosure.
[0079] A platform can be used to hold and / or move the tube member during the cutting process. The platform can be controlled by a precision motor system that can translate and / or rotate the tube member at a micron or sub-micron precision level. For example, during the cutting process, the platform can be used to hold and / or move the tube member when the beam pulse from the laser source is aimed at and deposited on the tube member. In some embodiments, the laser source includes a series of optical devices that can be controlled and / or adjusted during the cutting process while the tube member is being held and / or moved by the platform.
[0080] In an embodiment, the tube member is held at a fixed axial position. The laser source can be actuated to deposit the beam pulse on the tube member while the tube member rotates or turns at the fixed axial position, thereby forming a cut having a predetermined cut width and / or length. The cut can be a transverse cut formed in a plane orthogonal to the longitudinal axis of the tube member or in a plane at an angle to the plane orthogonal to the longitudinal axis of the tube member. After achieving the desired length of the cut (measured in degrees), the laser source can be turned off.
[0081] In an embodiment, the tube member is held at a first axial position. The laser beam pulse can be deposited on the tube member while the tube member is rotating at the first axial position. A first vertical cut is formed at the first axial position of the tube member. Then, the tube member is translated to a second axial position. While the tube member is rotating at the second axial position, the pulse of the laser beam can be deposited on the tube member. A second vertical cut is formed at the second axial position of the tube member. In this way, multiple vertical cuts can be formed at multiple axial positions in the tube member.
[0082] In an embodiment, the tube member is translated from a first axial position to a second axial position and the tube member is rotated during the translation. A laser beam pulse can be deposited onto the tube member while the tube member is being translated and rotated simultaneously. In this manner, a helical cut can be formed in the tube member extending between the first axial position and the second axial position. The laser source can be turned on and off while the tube member is being translated and rotated simultaneously to form a plurality of helical cuts.
[0083] In step 1208, the tube member is coupled to an elongate polymeric liner. The polymeric liner can be inserted inside the tube member and the polymeric liner can be securely combined with the tube member using a suitable bonding means.
[0084] In step 1210, a jacket layer can be applied to the tube member-polymeric liner assembly, for example, by coating. Suitable materials for the jacket layer include, but are not limited to, thermoplastic elastomers (TPE) such as polyether block amide, thermoplastic polyurethane, polyethylene, nylon, and the like.
[0085] Various embodiments of the intravascular device and the method of manufacturing the intravascular device have been described with reference to the figures. It should be noted that aspects described in connection with a particular embodiment are not necessarily limited to that embodiment and can be practiced in any other embodiment. The figures are intended to illustrate the use of the embodiments and are not intended to provide an exhaustive description or to limit the scope of the disclosure. Alternative structures, components, and materials will be readily recognizable without departing from the principles of the claimed invention. Additionally, although some embodiments of the disclosure have been described in connection with catheter devices, this is not intended to be limiting. For example, a tube member including a plurality of vertical cuts and / or helical cuts can be configured as a component for a guide wire device and other intervascular devices. As an example, a guide wire device can include an elongate core wire and a tube member disposed along the distal section of the core wire as described herein.
[0086] Unless specifically defined otherwise, all technical and scientific terms used herein have the meanings as commonly understood by one of ordinary skill in the art. As used in the specification and the appended claims, unless the context clearly dictates otherwise, the singular forms "a", "an", and "the" also include plural references. The term "or" as used herein 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 user or medical staff side. The term "distal" and its grammatical equivalents refer to a position, direction, or orientation away from the user or medical staff side. The terms "backward", "forward", etc. are not intended to limit the referenced components to a specific orientation. It should be understood that such terms refer to the orientation of the referenced components as illustrated in the respective figures; the systems and devices of the present disclosure can be used in any orientation suitable for the user. The terms "first", "second", etc. may be used to distinguish one element from another when describing various similar elements. It should be noted that the terms "first" and "second" as used herein include references to two or more. In addition, unless the context clearly dictates otherwise, the use of the terms "first" or "second" should not be construed as in any particular order. The order of performing method steps may vary in alternative embodiments. One or more method steps may be completely skipped, and one or more optional steps may be included. All numerical values are provided for illustration purposes and are considered to be modified by the term "about" whether or not clearly indicated. The term "about" generally refers to a range of values that one of ordinary skill 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 digit. The recitation of a numerical range by endpoints includes all numbers within that range.
[0087] Those skilled in the art will understand that various other modifications can be made. All such variations and modifications are contemplated by the inventors and are within the scope of the present invention.
Claims
1. An intravascular device comprising a tubular member, the tubular member comprising a distal portion and a proximal portion, wherein: the distal portion of the tubular member comprising a plurality of cutouts extending circumferentially about a longitudinal axis of the tubular member, the plurality of cutouts of the distal portion of the tubular member comprising a first pitch, a first cut length, and a first uncut length; the proximal portion of the tubular member comprising a plurality of cutouts extending circumferentially about the longitudinal axis, the plurality of cutouts of the proximal portion of the tubular member comprising a second pitch, a second cut length, and a second uncut length; and The first pitch is smaller than the second pitch, the first cut length is larger than the second cut length, and the first uncut length is smaller than the second uncut length.
2. The intravascular device according to claim 1, wherein: A combination of the first cut length and the first uncut length is greater than or equal to a combination of the second cut length and the second uncut length.
3. The intravascular device according to claim 1, wherein: The plurality of cuts of the distal portion include a first cutting width, and the plurality of cuts of the proximal portion include a second cutting width that is smaller than the first cutting width.
4. The intravascular device according to claim 1, wherein: 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 intravascular device according to claim 1, wherein: 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 intravascular device according to claim 1, wherein: 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 intravascular device according to claim 1, wherein: The tubular member further includes a transition portion between the distal portion and the proximal portion, the transition portion of the tubular member including a plurality of cutouts extending circumferentially around the longitudinal axis of the tubular member, Wherein, the plurality of cuts of the transition portion are spiral cuts and include a third pitch, a third cut length, and a third uncut length.
8. The intravascular device according to claim 7, wherein: The third pitch of the plurality of cutouts of the transition portion increases in a proximal direction.
9. The intravascular device according to claim 8, wherein: The third pitch increases linearly.
10. The intravascular device according to claim 8, wherein: The third pitch increases non-linearly.
11. The intravascular device according to claim 8, wherein: The third cut length and the third uncut length of the transition portion are constant.
12. The intravascular device according to claim 8, wherein: The third cut length decreases in the proximal direction and the third uncut length increases in the proximal direction.
13. The intravascular device according to claim 7, wherein: The plurality of cutouts of the transition portion include a third cut width that is smaller than the first cut width of the plurality of cutouts of the distal portion.
14. The intravascular device according to claim 7, wherein: The third pitch is constant, the third cut length decreases in a proximal direction, and the third uncut length increases in the proximal direction.
15. The intravascular device of claim 1, wherein: The tubular member further includes a transition portion between the distal portion and the proximal portion, the transition portion of the tubular member including a plurality of cutouts extending circumferentially around the longitudinal axis of the tubular member, wherein the plurality of cutouts of the transition portion are vertical cutouts; and The plurality of cuts of the transition portion include a third pitch that increases in a proximal direction, a third cut length that decreases in the proximal direction, and a third uncut length that increases in the proximal direction.
16. The intravascular device of claim 1, wherein: The distal portion of the tube member extends a length of 10 cm or less from a distal end of the tube member, and the proximal portion of the tube member extends from a position of 15 cm or more from the distal end.
17. The intravascular device of claim 16, wherein: The first pitch of the plurality of cutouts of the distal portion is in a range from 0.03 mm to 0.30 mm, and the second pitch of the plurality of cutouts of the proximal portion is in a range from 0.10 mm to 1.00 mm.
18. The intravascular device of claim 17, wherein: The plurality of cuts of the distal portion include a first cutting width within a range from 0.020 mm to 0.160 mm, and the plurality of cuts of the proximal portion include a second cutting width within a range from 0.020 mm to 0.051 mm.
19. The intravascular device of claim 18, wherein: The first cut length of the multiple cuts of the distal portion is in the range from 60 degrees to 177 degrees, the first uncut length of the multiple cuts of the distal portion is in the range from 3 degrees to 15 degrees, and wherein the second cut length of the multiple cuts of the proximal portion is in the range from 60 degrees to 165 degrees, and the second uncut length of the multiple cuts of the proximal portion is in the range from 15 degrees to 40 degrees.
20. The intravascular device of claim 19, wherein: The combination of the first cut length and the first uncut length is from 75 degrees to 180 degrees, and the combination of the second cut length and the second uncut length is from 75 degrees to 180 degrees.
21. The intravascular device of claim 1, further comprising an elongated inner liner having a lumen, wherein: The tubular member surrounds at least a distal portion of the elongated liner.
22. The intravascular device of claim 1, further comprising an elongated core wire, wherein: The tubular member surrounds at least a distal portion of the elongated core wire.
Citation Information
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