Guidewires are often used to lead or guide catheters or other interventional devices to a targeted anatomical location within a patient's body. Typically, guidewires are passed into and through a patient's vasculature in order to reach the target location, which is often at the patient's heart or brain, for example. Radiographic imaging may be utilized to assist in navigating the guidewire to the targeted location. In many instances, the guidewire is placed within the body and is then used to guide one or more catheters or other interventional devices to the targeted anatomical location for the delivery of drugs, stents, embolic coils, or other substances or devices for treating the patient.
In many applications, the guidewire must be routed through the tortuous bends and curves of a vasculature passageway to arrive at the targeted anatomy. For example, directing the guidewire to portions of the neurovasculature requires passage through the internal carotid artery and other tortuous paths. Accordingly, such guidewires require sufficient flexibility, particularly at distal portions, to navigate effectively. However, other design aspects must also be considered. For example, the guidewire must also be able to provide sufficient torquability (i.e., the ability to transmit torque applied at the proximal end all the way to the distal end), pushability (i.e., the ability to transmit axial push to the distal end rather than bending and binding intermediate portions), and structural integrity for performing intended medical functions.
Some guidewires are constructed with a core wire (often simply referred to as the core) and an outer tube that surrounds a distal portion of the core. The outer member may also include machined slots or fenestrations to increase its bending flexibility. The intent behind such designs is to reduce the diameter of the core in the distal sections of the guidewire in order to increase the flexibility of the core, while utilizing the larger outer diameter of the outer member for torque transmission.
While such guidewires have been successful, several limitations remain. For example, the core wires of such devices contribute to the axial stiffness of the device, which is beneficial for enabling good “pushability” and linear control. However, if the distal end of the guidewire comes into contact against tissue and the core wire has excessive columnar stiffness, tissue could be injured.
The use of a core wire and a surrounding tube also creates an annular space between the outer surface of the core and the inner surface of the tube. When the guidewire navigates a bend, the core may move out of alignment with the center line of the tube. Such off-centering can disrupt the smooth distal transmission of rotational movement, and can cause a buildup and sudden release of forces resulting in unwanted “snap” and/or “whip” movements. This disruption to the tactile feel and control of the guidewire can make it more difficult for the operator to rotationally position the guidewire as intended, raising the risk of interventional procedure delays, suboptimal outcomes, inability to access the target location, or even tissue injury.
Accordingly, there is an ongoing need for improved guidewires and other intravascular devices. In particular, there is an ongoing need for intravascular devices having core wires optimized to enhanced benefits relative to devices with conventional core wires.
The present disclosure describes microfabricated core wires configured for use in an intravascular device such as a guidewire or microcatheter. A microfabricated core wire includes a plurality of disks spaced apart from one another along a length of the distal section and a plurality of longitudinally extending ribbons interposed between the disks, each ribbon extending between and connecting a pair of adjacent disks. Various arrangements of disks and ribbons may be provided to control stiffness across a length of the core wire, particularly at or near a distal section of the core wire.
In one embodiment, the disks and ribbons are arranged to form a preferred bending plane in the distal section of the core wire, or to form multiple preferred bending planes in the distal section of the core wire. For example, the disks and ribbons are arranged so as to enable the distal section to form a compound curve.
In one embodiment, a distal section of the core wire includes a first portion and a second portion that is distal of the first portion, wherein the first portion is configured to provide a first preferred bending plane, and the second portion is configured to provide a second preferred bending plane different from the first preferred bending plane. In some embodiments, the first and second preferred bending planes are substantially orthogonal to one another
In one embodiment, a core wire may include an arrangement of disks and ribbons where the ribbons have any combination of: a rotational offset; a height placement offset; variable ribbon height; variable ribbon width; multiple sections associated with different preferred bending planes; and intentional shaping ribbons
This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an indication of the scope of the claimed subject matter.
Various objects, features, characteristics, and advantages of the invention will become apparent and more readily appreciated from the following description of the embodiments, taken in conjunction with the accompanying drawings and the appended claims, all of which form a part of this specification. In the Drawings, like reference numerals may be utilized to designate corresponding or similar parts in the various Figures, and the various elements depicted are not necessarily drawn to scale, wherein:
The tube 20 may be microfabricated to include various cutting patterns to control flexibility of the tube 20. The tube 20 extends to an atraumatic distal tip 22, which often comprises a polymer material. The tube itself may be made from any suitable material. A highly flexible or superelastic material, such as nitinol or other materials with similar properties, are suitable.
The overall length of the guidewire device 10 may vary according to application needs, but typically ranges from about 200 cm to about 300 cm. The length of the microfabricated tube 20 may also vary according to particular application needs, but will typically range from about 25 cm to about 45 cm.
Often, a second distal section 18 of the core wire 11 is flattened and has a rectangular cross-sectional shape, as shown in the cross-sectional view of
The core wire 11 provides beneficial internal structure and axial stiffness to distal sections of the guidewire device 10. However, too much stiffness in the core wire 11 may be detrimental. For example, if the core wire 11 has too much column stiffness, particularly at distal sections of the core wire 11, then bumping the distal end of the guidewire against tissue could cause injury to the tissue. This could happen during navigation of the guidewire through the vasculature, for example. Put another way, if the column stiffness of the core wire 11 is too high, the distal tip of the device will impinge and/or puncture contacted tissue before the core wire laterally deflects under the applied load.
Guidewire devices such as guidewire device 10 also typically have an annular space between the outer surface of the core wire 11 and the inner surface of the tube 20. Because of the annular space, when the guidewire device navigates a bend, the core wire 11 may move out of alignment with the center line of the tube 20. Such off-centering can disrupt the smooth distal transmission of rotational movement, and can cause a buildup and sudden release of forces resulting in undesirable “snap” and/or “whip” movements.
For a given diameter of tube 20, simply increasing the diameter or cross-sectional size of the core wire 11 to better fill the annular space is not a practical option because doing so would make the distal sections of the core wire 11 much too stiff. In other words, though making the core wire 11 larger in distal sections of the guidewire may provide better centering of the core wire 11 within the tube 20, it likely also results in excessive bending stiffness, column stiffness, or both.
As one example, a guidewire core 11 may be ground down to about 0.002 inches in diameter near the distal end. Flattening the distal end 18 of the core provides a width of about 0.003 inches in the longest dimension. The inner diameter of the tube 20 may be about 0.008 inches. This means that the ratio of the outer diameter or size (i.e., size in longest cross-sectional dimension) of the distal section of the core wire to the inner diameter of the tube is about 0.25 or 0.375. For larger guidewire sizes, the core wire typically has similar distal dimensions because of the practical limits on diameter/size required to avoid excessive stiffness. Thus, for larger guidewire sizes with larger tube diameters (e.g., 0.018 inches, 0.024 inches), the ratios of core diameter/size to tube inner diameter are even lower.
A lower ratio means there is more annular space to be filled and thus more potential for the core wire to become axially misaligned with the tube at bends. As mentioned above, increasing the diameter/size of the core risks overly increasing the stiffness (bending and/or column) of the core. However, the microfabricated core wires disclosed herein can be provided with a relatively larger diameter/size. The microfabricated structure of the core provides additional bending flexibility and/or reduced column stiffness that allows the use of larger diameters/sizes without the usual associated problems of excessive stiffness.
For example, an intravascular device (e.g., guidewire) utilizing a microfabricated core wire as disclosed herein may include a tube such as shown in
Thus, for an intravascular device having a tube with an inner diameter of about 0.008 inches, the core wire may have a diameter/size greater than 0.002 inches or greater than about 0.003 inches, such as about 0.0035 inches to about 0.008 inches, or about 0.004 inches to about 0.006 inches, or within a range defined by endpoints selected from any two of the foregoing values. Where the inner diameter of the tube is a different size, these values may be adjusted proportionally.
For purposes of determining the above ratios, the diameter/size of the core wire should include at least the distal most 1 to 3 cm of the core wire. Providing relatively larger sizes at the very distal regions of the core while maintaining acceptable flexibility and performance characteristics at these distal regions represents an advancement over conventional intravascular devices. That is, a standard guidewire core may have a larger diameter/size at more proximal regions of the device, but not at the more distal regions of the device.
The disks 102 and ribbons 104 may be formed using any suitable microfabrication method, including cutting or other micro-machining techniques and/or laser ablation/cutting techniques (e.g., using a femtosecond laser). Machining or ablating away some of the stock material of the core wire forms the ribbons 104 while the disks 102 are defined between each “cut” of the stock material. The arrangement of disks 102 and ribbons 104 can be beneficially tailored to provide desired flexibility characteristics of the core wire 100. As compared to a similarly sized core wire that has not been microfabricated, the microfabricated core wire 100 can be made to be significantly more flexible.
The length of the microfabricated distal section of the core wire 100 may vary according to particular application needs. In some embodiments, it may have a length of at least about 0.5 cm up to about 1 cm, or up to about 3 cm, or up to about 5 cm, or up to about 7.5 cm, or up to about 10 cm, or up to about 15 cm, or up to about 20 cm, or up to about 25 cm, or up to about 30 cm, or up to about 35 cm.
The disks 102 and ribbons 104 may be configured with various different sizes and shapes to provide different characteristics to the core wire 100. For example, spreading out the “cuts” (used herein to include cuts, ablations, or other subtractive machining processes) of the core wire 100 so that there is greater space between each ribbon 104 will make the resulting disks 102 longer. The length of a disk is the distance from one side of a disk to the other in a longitudinal direction. Longer disks 102 and greater spacing between ribbons 104 results in greater stiffness than shorter disks 102 with less spacing between ribbons 104, all else being equal. Each disk also has a disk width, defined as the diameter of the planer face of the disk. This disk width may be equal to the width of the core wire 100. The disk width may also vary according to the needs of the application and different disk widths may be used for different sections of the core wire (e.g., the distal section may have a narrower disk width than more proximal sections).
The length of ribbons 104 (distance from one disk to the next in the longitudinal direction) may also be adjusted. Longer ribbons 104 provide more flexibility than shorter ribbons 104, all else being equal. Each ribbon 104 also has a width defined as the distance between lateral face 116a to lateral face 116b. Narrower ribbons provide more flexibility than wider ribbons, all else being equal. Each ribbon 104 also has a height defined as the distance between planar face 114a to planar face 114b. The height of the ribbons can be controlled by adjusting the depth of the cut made into the material and thus the amount of material removed to form the ribbon. Ribbons with shorter height provide more flexibility than ribbons with greater height, all else being equal.
In some embodiments, the disks 102 and ribbons 104 are arranged to form a preferred bending plane in the distal section of the core wire 100. As shown, because multiple ribbons 104 are aligned within the same general plane, the core wire 100 will have a preferred bending plane orthogonal to the width of the ribbons 104 while resisting bending in the plane parallel to the width of the ribbons 104. Other embodiments may be configured to provide additional bending planes or to avoid the formation of any bending planes (see, e.g.,
Other embodiments may utilize different rotational offsets. For example, the rotational offset may be more or less than 90 degrees so that when applied to multiple ribbons along a length of the core wire 200 the ribbons form a “helical” pattern that rotates about the circumference of the core wire as it moves along its length. A helical pattern minimizes preferred bending axes in the core wire 200.
Other beneficial “distributed” arrangements may alternatively be utilized to avoid preferred bending axes. These are described in more detail in International Patent Publication No. WO 2018/218216 A1, titled “Micro-Fabricated Medical Device Having a Non-Helical Cut Arrangement,” and which is incorporated herein by this reference in its entirety. WO 2018/218216 A1 describes various cut patterns mostly in the context of tubular members, and may be applied to any of the tubes used with the presently disclosed core wires. It is contemplated by the present disclosure that the same cut pattern principles described in WO 2018/218216 A1 may be applied to the core wires described herein.
The rotational offset is shown here as being applied to each successive ribbon 204. In other embodiments, a rotational offset may be applied less frequently, such as after a set of two or more ribbons (referred to herein as a “ribbon set”), or according to some other pattern. The rotational offset may be a constant value. Alternatively, a varying rotational offset (such as one that gets progressively greater or smaller toward the distal end 206) may be applied.
Adjusting the widths of the ribbons 404 may be accomplished by forming cuts on lateral surfaces of the ribbons 404 in addition to the cuts that form the planar surfaces. In this way, the lateral surfaces of the ribbons 404 do not necessarily align with the circumference of the adjacent disks 402. The extra space resulting from these lateral cuts can also beneficially allow room for placement of a marker band on or around the ribbon 404. The marker band may be made of a radiopaque material (e.g., platinum or other material more radiopaque than stainless steel).
In the illustrated embodiment, a height offset is applied to each successive ribbon 604 along a length of the core wire 600, resulting in a “slanted” arrangement of ribbons 604. The height offset may be adjusted to make the slant(s) of the core wire 600 shallower or steeper. The height offset may be applied between each successive ribbon 604, as shown, or may be applied between ribbon sets. The height offset may be a constant value. Alternatively, a varying height offset (such as one that gets progressively greater or smaller toward the distal end 606) may be applied. The result of the successive height offset is a slanted profile, as illustrated in
Generally, embodiments such as those in
Because the separate bending planes are associated with discrete, separate regions of the core wire 800, the separate bending planes allow the core wire 800 to be bent and/or shaped into a compound curve. This can beneficially enable the surgeon to put the distal tip of an intravascular device into multiple orientations by utilizing one or more of the bending planes in addition to selectively rotating the intravascular device.
The exemplary microfabricated core wires shown in
Any of the microfabricated core wires described herein may be utilized in an intravascular device such as a guidewire. For example, any of the microfabricated core wires described herein may replace the core wire 11 of
In some embodiments, the difference between the outer diameter of the core wire and the inner diameter of the tube will be optimized to improve the annular space between the core wire and the tube. In some embodiments, the ratio of the outer diameter of the core wire to the inner diameter of the tube is greater than about 0.375, preferably about 0.5 or greater, more preferably about 0.625 or greater.
Although the microfabricated core wires disclosed herein can be made larger in diameter/size at distal sections than conventional core wires, and thereby better fill the annular space between the core wire and the tube, there may still be some amount of annular space remaining. Various additional centering mechanisms, including one or more coils, polymer fillers, and/or tubes, may be provided to help further fill the annular space and further enhance centering. Such centering mechanisms are described in greater detail in U.S. patent application Ser. No. 16/742,211, titled “Guidewire with Core Centering Mechanisms,” and which is incorporated herein by this reference in its entirety.
While certain embodiments of the present disclosure have been described in detail, with reference to specific configurations, parameters, components, elements, etcetera, the descriptions are illustrative and are not to be construed as limiting the scope of the claimed invention.
Furthermore, it should be understood that for any given element of component of a described embodiment, any of the possible alternatives listed for that element or component may generally be used individually or in combination with one another, unless implicitly or explicitly stated otherwise.
In addition, unless otherwise indicated, numbers expressing quantities, constituents, distances, or other measurements used in the specification and claims are to be understood as optionally being modified by the term “about” or its synonyms. When the terms “about,” “approximately,” “substantially,” or the like are used in conjunction with a stated amount, value, or condition, it may be taken to mean an amount, value or condition that deviates by less than 20%, less than 10%, less than 5%, or less than 1% of the stated amount, value, or condition. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.
Any headings and subheadings used herein are for organizational purposes only and are not meant to be used to limit the scope of the description or the claims.
It will also be noted that, as used in this specification and the appended claims, the singular forms “a,” “an” and “the” do not exclude plural referents unless the context clearly dictates otherwise. Thus, for example, an embodiment referencing a singular referent (e.g., “widget”) may also include two or more such referents.
It will also be appreciated that embodiments described herein may include properties, features (e.g., ingredients, components, members, elements, parts, and/or portions) described in other embodiments described herein. Accordingly, the various features of a given embodiment can be combined with and/or incorporated into other embodiments of the present disclosure. Thus, disclosure of certain features relative to a specific embodiment of the present disclosure should not be construed as limiting application or inclusion of said features to the specific embodiment. Rather, it will be appreciated that other embodiments can also include such features.
This application claims priority to and the benefit of U.S. Provisional Patent Application Ser. No. 63/087,411, filed Oct. 5, 2020, and titled “Microfabricated Core Wire for an Intravascular Device.” The entirety of the foregoing application is incorporated herein by this reference.
Number | Date | Country | |
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63087411 | Oct 2020 | US |