CN121038840A

CN121038840A - Guidewire including a slender body with a flexible distal segment

Info

Publication number: CN121038840A
Application number: CN202480028343.0A
Authority: CN
Inventors: A·R·纳格斯瓦兰; D·J·迪恩
Original assignee: Covidien LP
Current assignee: Covidien LP
Priority date: 2023-04-28
Filing date: 2024-04-26
Publication date: 2025-11-28
Also published as: EP4701707A1; WO2024226927A1

Abstract

A guidewire includes: a core wire defining a longitudinal axis; and an elongated body extending along the longitudinal axis, the elongated body defining: an inner cavity configured to retain a distal portion of the core wire; and a plurality of openings, wherein each of the plurality of openings defines an arc defining a radius of curvature and a concave portion facing a distal end or a proximal end of the elongated body, and wherein the radius of curvature of the plurality of openings varies along the longitudinal axis.

Description

Guidewire including an elongate body with a flexible distal section

This patent application claims priority from U.S. patent application Ser. No. 18/645,022, entitled "GUIDEWIRE INCLUDING AN ELONGATED BODY WITH A FLEXIBLE DISTAL SECTION," filed 24 at 4, 2024, which claims the benefit of U.S. provisional patent application Ser. No. 63/499,005, entitled "GUIDEWIRE INCLUDING AN ELONGATED BODY WITH A FLEXIBLE DISTAL SECTION," filed 28 at 4, 2023, which is incorporated herein by reference in its entirety.

Technical Field

The present disclosure relates to a medical guidewire.

Background

Medical catheters defining at least one lumen have been proposed for use with various medical procedures. For example, in some cases, medical catheters may be used to access and treat defects in blood vessels, such as, but not limited to, lesions or occlusions in blood vessels. A medical guidewire may be disposed within the catheter lumen and configured to control navigation of the medical catheter within the patient's body.

Disclosure of Invention

In some examples, a guidewire includes an elongate body including a proximal section and a distal section, the distal section including a wall defining one or more openings. One or more openings extend at least partially through the inner wall of the elongate body at a thickness. The guidewire may also include one or more other elements such as, but not limited to, an outer sheath, a core wire, and a support member (e.g., a coil and/or braid). One or more openings defined in the wall of the distal section of the elongate body may increase the bending flexibility of the distal section relative to the proximal section of the elongate body. The one or more openings may also provide the distal section of the elongate body with increased bending flexibility without reducing the tensile strength below a threshold for navigability through the vasculature. The present disclosure also describes examples of methods of forming the elongate bodies disclosed herein and methods of using the guidewire with the example elongate bodies.

In some examples, the present disclosure describes a guidewire comprising a core wire defining a longitudinal axis, and an elongate body extending along the longitudinal axis, the elongate body defining a lumen configured to hold a distal portion of the core wire, and a plurality of openings, wherein each opening of the plurality of openings defines an arc defining a radius of curvature and a concave portion facing a distal end of the elongate body or a proximal end of the elongate body, and wherein the radius of curvature of the plurality of openings varies along the longitudinal axis.

In some examples, the present disclosure describes a method of manufacturing a guidewire that includes determining placement of a plurality of openings along an outer surface of an elongate body, determining a radius of curvature for each of the plurality of openings, and forming the plurality of openings into the outer surface of the elongate body, each opening defining a corresponding determined radius of curvature.

In some examples, the present disclosure describes a guidewire comprising a core wire, and an elongate body extending along a longitudinal axis, the elongate body defining a lumen, wherein a distal portion of the core wire is positioned within the lumen, and a plurality of openings disposed along the elongate body between a distal end of the elongate body and a proximal end of the elongate body, wherein each of the plurality of openings defines an arc defining a radius of curvature and extending from a first end to a second end, wherein the first end and the second end are disposed at a same longitudinal position along the elongate body, and wherein for each arc a center of the arc is disposed at a different longitudinal position than the first end and the second end of the arc, wherein the plurality of openings define a plurality of rows of openings around a circumference of the elongate body, wherein a longitudinal distance between longitudinally adjacent rows of openings increases or decreases between the distal end and the proximal end of the plurality of openings.

The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the technology described in this disclosure will be apparent from the description and drawings, and from the claims.

Drawings

FIG. 1 is a conceptual diagram illustrating an example guidewire having an elongate body defining one or more openings in a wall of the elongate body.

Fig. 2A is a conceptual diagram illustrating an elongate body of the example guidewire of fig. 1.

Fig. 2B is a conceptual diagram illustrating a cross-sectional view of a distal section of the example guidewire of fig. 2A, the cross-section being taken along line A-A in fig. 2A.

Fig. 3A is a conceptual diagram illustrating an example opening of the elongated body of fig. 2A.

Fig. 3B is a conceptual diagram illustrating another example opening of the elongate body of fig. 2A.

Fig. 3C is a conceptual diagram illustrating an example of the elongate body of fig. 2A, the elongate body having been cut longitudinally and laid flat.

Fig. 3D is a conceptual diagram illustrating another example of the elongate body of fig. 2A, the elongate body having been cut longitudinally and laid flat.

Fig. 4 is a conceptual diagram illustrating a distal section of the elongate body of fig. 1.

Fig. 5 is a conceptual diagram illustrating a proximal section of the elongate body of fig. 1.

Fig. 6A is a graph illustrating an example bending stiffness of the example guidewire of fig. 1.

Fig. 6B is a graph illustrating an example tensile stiffness of the example guidewire of fig. 1.

Fig. 6C is a graph illustrating an example torque response of the example guidewire of fig. 1.

Fig. 7 is a flow chart illustrating an example method of manufacturing the elongated body of fig. 1.

Fig. 8 is a flow chart illustrating another example method of manufacturing the elongated body of fig. 1.

Detailed Description

In some examples, the medical devices described herein may be used with a medical catheter ("catheter") that includes a relatively flexible catheter body configured to navigate through a patient's vasculature, such as tortuous vasculature in a patient's brain. Catheters may be navigated within the vasculature via the use of medical guidewires ("guidewires"). The guidewire includes a relatively flexible distal section that may exhibit increased flexibility relative to a proximal section of the guidewire. In some examples, the guidewire includes an elongate body (also referred to herein as an "elongate tube") and an outer sheath, and the increased flexibility of the distal section can be attributable at least in part (e.g., partially or fully) to the configuration of the elongate body. For example, the distal section of the elongate body may include one or more openings (also referred to herein as "voids" and/or "cuts") that help increase the bending flexibility of the distal section of the elongate body while maintaining the desired tensile strength of the elongate body. The one or more openings can have any suitable configuration that facilitates increasing the bending flexibility of the elongate body while maintaining the tensile strength of the elongate body and the entire guidewire. Each of the one or more openings may be free of material in the wall or in a locally thinner portion of the wall (e.g., a groove, recess, pit, through hole, etc. in other continuous surfaces), or may be a cut in the wall of the elongate body that is formed without removing material from the wall.

Although examples of the present disclosure have been described primarily with reference to a guidewire and openings on an elongate body, the elongate body as described in any of the examples included herein may be used in other medical applications, for example, as a liner or support member in a medical catheter, and the like.

The elongate body or the guidewire body may require a minimum tensile stiffness and/or a minimum tensile strength for the particular use of the guidewire. Insufficient tensile stiffness or strength can translate into poor navigability of the guidewire through the vasculature of the patient as the clinician is advancing and retracting the guidewire in tortuous anatomy. For example, if the distal stretch stiffness of the elongate body is insufficient, the distal end of the guidewire may not retract from the patient at the same rate as the proximal section, which may reduce the clinician perceived control of the guidewire. Furthermore, if the elongate body has insufficient tensile stiffness, the distal end of the guidewire may remain in place while the proximal end stretches away from the distal end, which may cause the distal section of the guidewire to disengage from the remainder of the guidewire.

The tensile strength and bending flexibility provided by the arrangement of one or more openings in the elongate body described herein may translate into better navigability when the clinician is advancing or retracting the guidewire, such as in tortuous anatomy. For example, the tensile strength of an elongate body defining one or more openings described herein may be sufficient to enable the distal section of the elongate body to be retracted from the patient without compromising the structural integrity of the guidewire. Further, the elongate bodies described herein may have a tensile stiffness that enables both the distal end and the proximal section of a guidewire comprising one of the elongate bodies to retract from the vasculature of a patient at the same rate, which may allow the clinician to perceive more control over the guidewire.

By using the devices and techniques herein, the elongate body can have sufficient tensile strength to allow a clinician to safely retract the distal section of the elongate body even if, for example, a blood vessel around the distal end of the guidewire is contracting the guidewire. The tensile strength of the elongate body can help ensure that the distal section of the elongate body does not separate from the proximal section of the elongate body, for example, during a medical procedure.

The elongate body may include walls defining an inner lumen and an outer surface of the elongate body. Each opening in the elongate body may extend at least partially through the wall, for example at least partially through a wall of a certain thickness, or all the way through a wall of a certain thickness, thereby exposing the lumen of the elongate body. The thickness of the wall may be measured in a direction orthogonal to the longitudinal axis of the elongate body. In some examples, the wall may be thinner at the opening, which may allow the elongate body to have more flexibility at the region that includes and is adjacent to the opening.

In some examples, where the one or more openings extend only partially through a wall of a thickness of the elongate body (also referred to herein as a "partial cut" or "partial opening"), the partial opening may be defined by an outer surface of the wall. For example, a portion of the opening may extend from the outer surface of the wall toward the lumen, but may not extend all the way through the wall to the lumen of the elongate body. By positioning a portion of the opening onto the outer surface of the wall, the inner surface of the elongate body may remain substantially smooth (e.g., smooth or nearly smooth, or without protrusions or indentations that would otherwise obstruct the passage of the medical device), which may facilitate the passage of one or more medical devices (e.g., guide members, embolic protection devices, or embolic retrieval devices, etc.) through the lumen of the elongate body. However, in other examples, the partial opening may be defined by the inner surface of the wall in addition to or instead of the outer surface. In some examples, where the one or more openings extend entirely through a wall of a thickness of the elongate body (also referred to herein as a "through-cut" or "through-opening"), the one or more openings may be arranged such that the elongate body is not divided into physically separate portions. For example, the opening may not extend around the entire circumference or perimeter of the elongate body.

The one or more openings defined by the distal section of the elongate body may be arranged in one or more patterns, as described in further detail below. In some examples, one or more openings may be arranged in a mirror image pattern, wherein longitudinally adjacent openings define a reflective symmetry and/or are mirror images about a reference axis. The reference axis may be orthogonal to the longitudinal axis or may be separated from the longitudinal axis by an angle of less than 90 degrees. Such a mirror image pattern may reduce the spacing between adjacent openings, thereby increasing the density of the openings and increasing the bending flexibility of the elongated body. In some examples, the one or more openings may define one or more arcs that define a varying radius of curvature. In such examples, the one or more openings at the more proximal section of the elongate body may have a different radius of curvature than the one or more openings at the more distal section of the elongate body. Such an arc may increase the overall length of the one or more openings and the corresponding tensile resistance while maintaining sufficient integrity of the elongate body in response to torque. In some examples, one or more other dimensions of the one or more openings may vary along the length of the elongate body between the distal end and the proximal end of the elongate body.

The elongate body described herein includes a distal section and a proximal section having one or more openings. In some examples, the elongate body may consist essentially of a proximal section and a distal section. In some examples, the distal section is immediately adjacent to and mechanically connected to the proximal section (e.g., integrally formed with the proximal section or formed separately from the proximal section and attached thereto). The distal section of the elongate body may comprise a plurality of regions. The plurality of regions may be longitudinally arranged along the length of the distal section. Each of the plurality of regions may include openings having the same characteristics and/or dimensions. For example, the openings in the first region may define the same radius of curvature. As another example, the openings in the first region may all be oriented toward one end (e.g., distal end or proximal end) of the elongate body, and the first region may be a mirror image of the longitudinally adjacent region.

In some examples, a guidewire including an elongate body having a distal section defining one or more openings may be a variable stiffness guidewire that increases flexibility from a proximal end toward a distal end. For example, the proximal section of the elongate body may not include any openings, or may have an arrangement of openings that is different from the arrangement of openings of the distal section (e.g., fewer openings, a different pattern, or a different size) such that the distal section is more flexible than the proximal section. In this way, the opening defined in the distal section of the elongate body may configure the distal section to be more flexible than a more proximal section of the elongate body. The variable stiffness allows the guidewire to exhibit a relatively high level of pushability due to the stiffer proximal section of the elongate body contributing to the overall stiffness of the guidewire, and a relatively high level of flexibility at the distal section of the guidewire due at least in part to the configuration of the distal section of the elongate body.

In some examples, the guidewire described herein includes an elongate body, a support element (e.g., a coil member or a braided member, or a combination thereof), a core member (e.g., a core wire), and an outer sheath that can interact to provide sufficient structural integrity to the relatively flexible elongate body (e.g., column strength, which can be a measure of the maximum compressive load that can be applied to the elongate body without taking a permanent deformation) to permit advancement of the guidewire through the vasculature via thrust applied to the proximal section of the guidewire without causing, for example, buckling, kinking, or other undesired deformation (e.g., ovalization). The distal section of the guidewire may guide the guidewire through the vasculature of the patient. The example elongate bodies described herein may increase the flexibility of the distal section of the guidewire and, thus, may increase the navigability of the guidewire through the vasculature as compared to a guidewire comprising an elongate body that is otherwise identical but does not include one or more openings in the distal section. The elongate body may be formed of a biocompatible metal alloy (e.g., nitinol). The metal alloy may be formed into an elongated tube (e.g., hypotube, etc.) that defines an elongated body. In some examples, the elongate body may be formed as an elongate tube from one or more polymers (e.g., polytetrafluoroethylene (PTFE), etc.).

The guide wires described herein may be configured to exhibit a relatively high level of flexibility, pushability, torqueability (e.g., torque responsiveness), and/or structural integrity. In some examples, the guidewire includes an elongate body having a distal section defining one or more openings, a structural support member, and an outer sheath that interact to provide sufficient structural integrity (e.g., column strength) to the guidewire to advance the guidewire through the vasculature by a pushing force applied to the proximal section of the guidewire without causing buckling or undesirable bending (e.g., kinking) of the guidewire. In some examples, the flexible guidewire is configured to substantially conform to the curvature of the vasculature. Further, in some examples, the guidewire may define a post strength and flexibility that at least allows the distal section of the guidewire to navigate from the femoral artery through the patient's aorta and into the patient's intracranial vascular system, for example, to reach relatively distal treatment sites, including Middle Cerebral Artery (MCA), internal Carotid Artery (ICA), wili's ring, and tissue sites farther than the MCA, ICA, and wili's ring. The MCA, and thus the vasculature distal to the MCA, may be relatively difficult to access as the carotid siphon segment anatomy must be traversed to reach the location.

Although primarily described as being used to reach relatively distal vasculature sites, the guide wires described herein may be readily configured for use with other target tissue sites. For example, guidewires can be used to access tissue sites in the entire coronary and peripheral vasculature, gastrointestinal tract, urethra, ureter, fallopian tube, and other body cavities.

Fig. 1 is a conceptual diagram illustrating an example guidewire 100. The guidewire 100 may define a longitudinal axis 106 extending between the distal section 103A and the proximal section 103B. As shown, the guidewire 100 includes a core wire 102, an elongate body 104, and an atraumatic tip 105. The core wire 102 extends along a longitudinal axis 106 of the guidewire 100 between the distal section 102A and the proximal section 102B. The elongate body 104 extends along a longitudinal axis 106 between a distal end 104A and a proximal end 104B and defines a lumen. The distal end 104A may be coupled to the atraumatic tip 105 and/or the core wire 102. The core wire 102 may be disposed within a lumen defined by the elongate body 104. The elongate body 104 can be configured to retain the distal section 102A of the core wire 102 such that the elongate body 104 is mechanically responsive to a force exerted on the proximal section 102B of the core wire 102. For example, the elongate body 104 can be configured to retain the distal section 102A of the core wire 102 within a lumen defined by the elongate body 104. As described in more detail below, the elongate body 104 may define one or more openings in a wall of the elongate body 104.

The guidewire 100 may define a suitable length for accessing a target tissue site within a patient from a vascular access point. The length may be measured along the longitudinal axis 106 of the guidewire 100. The target tissue site may depend on the medical procedure in which the guidewire 100 and/or accompanying catheter is used. For example, if the catheter is a distal access catheter for accessing the vasculature in the patient's brain from a femoral artery access point at the groin of the patient, the length of the guidewire 100 may be at least about 125 centimeters (cm) to about 135cm, such as about 132cm, although other lengths may be used. The distal section 103A of the guidewire 100 may be disposed within the vasculature of the patient and the proximal section 103B may be disposed outside the body of the patient. The clinician may manipulate the proximal section 103B of the guidewire 100 to rotate, retract, and/or advance the distal section 103A of the guidewire 100 within the vasculature.

The guidewire 100 may be used to access a relatively distal location within a patient, such as the middle cerebral artery ("MCA") in the brain of the patient. MCAs, as well as other vasculature or other relatively distal tissue sites in the brain (e.g., relative to a vascular access point), may be relatively difficult to reach with a catheter due, at least in part, to the tortuous path (e.g., including relatively sharp twists or turns) through the vasculature to these tissue sites. The guidewire 100 may be structurally configured to be relatively flexible, pushable, and relatively resistant to kinking and buckling such that the guidewire may resist buckling when a pushing force is applied to a relatively proximal section of the catheter to advance the catheter body distally through the vasculature, and such that the guidewire may resist kinking when traversing around sharp turns in the vasculature. Kinking or buckling of the guidewire 100 may prevent the clinician from pushing the catheter body distally, such as through a turn effort. Such kinking or buckling of the guidewire 100 is more likely to occur at the distal portion 103A of the guidewire 100 because the distal portion 103A may experience a relatively greater bending force than the proximal portion 103B because both the leading portion of the guidewire 100 and the distal-most portion of the guidewire 100 are positioned in the vasculature, which may become progressively more tortuous from the vascular access point to the target tissue site.

As discussed in further detail below, one structural property that may at least contribute to the flexibility of the guidewire 100, particularly at the distal portion 103A, is the flexibility of the elongate body 104. The flexibility of the elongate body 104 may be based at least in part on a cutting pattern defined by one or more openings in the wall 107 of the distal section 103A. One or more openings in the distal section 103A of the elongate body 104 may improve the navigability of the guidewire 100 through the vasculature of a patient relative to another guidewire comprising the elongate body without any openings in the wall of the elongate body. Without being limited to any particular theory, the bending force exerted on the guidewire 100 may bend the guidewire 100 away from the longitudinal axis 106. For example, the bending force may bend the guidewire 100 along a plane orthogonal to the longitudinal axis 106. The bending force may create a compressive force in a portion of the guidewire 100 facing the bending direction of the guidewire 100 and a tensile force in a portion of the guidewire 100 facing away from the bending direction. One or more openings on the elongate body 104 can provide an interruption (e.g., void or cutout) for reducing the resulting tension and/or provide a space (e.g., void) for reducing the resulting compression force as compared to the same elongate body without openings, such that the elongate body 104 can provide reduced resistance to bending forces as compared to the same elongate body without any openings.

Core wire 102 may extend from atraumatic tip 105 to a proximal end of proximal portion 102B. During navigation of the core wire 102 within the vasculature of a patient, the distal section 102A may be disposed within the vasculature and the proximal section 102B may be external to the body of the patient. The clinician may manipulate the proximal segment 102B to advance, retract, rotate, and/or bend the guidewire 100 within the vasculature. The core wire 102 may transmit a force and/or torque, for example, applied to the proximal section 102B by a clinician, along the longitudinal axis 106 to the atraumatic tip 105. At least a portion of the distal section 102A is disposed within the lumen defined by the elongate body 104 and transmits force and/or torque from the proximal section 102B to the atraumatic tip 105. The core wire 102 may be formed from one or more biocompatible metal alloys, including but not limited to stainless steel. The core wire 102 may be selected for a variety of properties, including mechanical strength sufficient to maintain integrity and transfer force from the distal section 102B to the proximal section 102A, and flexibility sufficient to allow the core wire 102 to be positioned within a more proximal portion of the pathway in the vasculature. However, the mechanical strength of the core wire 102 may be substantially higher than that required for the forces experienced at the distal portion 103A.

The elongate body 104 is constructed with a higher flexibility than the core wire 102 while maintaining sufficient mechanical strength. The elongate body 104 defines one or more openings on an outer surface of the elongate body 104 from the distal end 104A to the proximal end 104B. The openings may have different patterns, sizes, and/or designs between the distal end 104A and the proximal end 104B, for example, to increase the flexibility of the distal section 110A of the elongate body 104 relative to the proximal section 110B of the elongate body 104. For example, during navigation of the catheter through relatively tortuous vasculature, the distal section 103A of the guidewire 100 may experience forces along the axis 106 (e.g., tensile or compressive forces), forces about the axis 106 (e.g., torque), and/or forces away from the axis 106 (e.g., bending forces). The distal section of the same elongate body, not including the opening, may provide resistance to these forces. While resistance to forces along and about the axis 106 may ensure adequate pushability of the guidewire 100, resistance to forces away from the axis 106 may reduce navigability of the guidewire 100. The opening may be configured to improve the navigability of the distal section 103A relative to an identical guidewire that does not include the opening by reducing the resistance of the elongate body 104 to forces away from the axis 106 without substantially reducing the resistance of the elongate body 104 to forces along and/or about the axis 106 (exceeding the resistance for maintaining pushability of the elongate body 104). For example, the flexibility of the distal section 103A of the elongate body 104 including the opening may be less than or equal to half the flexibility of the same elongate body that does not include the opening. The same elongated body may be a round wire of metal (e.g., stainless steel) of equal size that does include any openings. In some examples, distal section 110A including the opening is at least as flexible as a round wire without the opening, which defines a larger outer diameter than distal section 110A.

In some examples, the elongate body 104 includes openings having separate, opposing, and/or common properties that are configured to provide increased flexibility to the elongate body 104 as compared to an identical elongate body without any openings. For example, the respective properties may include properties of the respective openings, such as size or shape, the relative properties may include properties of two or more openings or groups of openings relative to each other, such as spacing, and the common properties may include properties of the plurality of openings, such as density of the openings, and/or flexibility of the distal section 110A or portions of the distal section 110A provided by the openings.

In some examples, the elongated body 104 includes openings arranged in a particular pattern configured to provide increased flexibility to the elongated body 104 as compared to the same elongated body without any openings. The pattern of one or more openings can be selected to achieve a threshold level of structural integrity (e.g., threshold bending stiffness, threshold tensile strength, threshold torsionality) while increasing the flexibility of the distal section 110A of the elongate body 104 relative to the distal section of the same elongate body without any openings. The pattern of one or more openings may define different arrangements and/or sizes from the distal end 104A to the proximal end 104B of the elongate body 104, e.g., to increase flexibility of the distal section 110A of the elongate body 104 while maintaining tensile strength of the distal section 110A.

Each opening in the elongated body 104 may define a continuous arc along an outer surface of the wall 107 of the elongated body 104. Each arc may be a semicircular arc, a parabolic arc, an elliptical arc, etc. Each arc may define a concave portion extending toward the distal end 104A or the proximal end 104B of the elongate body 104. Each arc may be defined along a plane along the longitudinal axis 106, e.g., such that each arc defines an end having the same longitudinal orientation and a center of the arc having a different longitudinal orientation than the ends of the arc. The arc of each opening may be defined by a radius of curvature. For example, the arc length of each opening is defined by the respective radius of curvature of the arc. In some examples, the opening may define a varying radius of curvature along the length of the elongate body 104 from the distal end 104A to the proximal end 104B.

In some examples, some of the openings may be mirror images of other openings. In such examples, one or more openings are mirror images of one or more other openings across a reference axis orthogonal to the longitudinal axis 106. Mirroring at least some of the openings may increase the density of openings on the elongate body 104 (e.g., may reduce the longitudinal distance between longitudinally adjacent openings) without changing other dimensions of the openings (e.g., the radius of curvature of the openings). Increasing the density of openings on a portion of the elongate body 104 (e.g., on the distal section 110A of the elongate body 104) may increase the flexibility of a portion of the elongate body 104 compared to the same elongate body without mirrored openings.

The openings may be arranged in circumferential rows around the outer surface of the elongated body 104. In some examples, each circumferential row of openings is disposed along a reference plane that is orthogonal to the longitudinal axis 106. In some examples, one or more circumferential row openings are offset from longitudinally adjacent circumferential row openings. For example, each of the first circumferential row of openings is circumferentially offset from a corresponding opening in a longitudinally adjacent second circumferential row of openings by a circumferential offset angle. The circumferential offset of longitudinally adjacent circumferential rows of openings may inhibit preferential bending of the elongated body 104 along a particular plane. In some examples, the elongate body 104 includes an opening that is shaped and/or positioned to locally increase flexibility of a portion of the elongate body 104 at or near a particular opening.

Each opening may be defined by a corresponding set of dimensions including length, width, beam length, spacing, radius of curvature, angular offset angle, and circumferential offset angle. The spacing of each opening defines a longitudinal distance between longitudinally alternating openings. The beam length of the openings defines the uncut length of the elongated body 104 between a first end of one opening and a second end of a circumferentially adjacent opening. The beam length may be measured along a reference plane orthogonal to the longitudinal axis 106. The angular offset angle defines an offset angle between two longitudinally alternating openings and/or between corresponding openings of a longitudinally spaced apart pattern of openings along the longitudinal length of the elongated body 104. The angular offset angle of the openings may define a rotational spacing between the openings and/or the repeating pattern of openings. The openings and/or repeating pattern of openings may define one or more helical or spiral patterns along the longitudinal length of the elongated body 104, each helical or spiral pattern defined by a corresponding rotational pitch. For example, the openings and/or the repeating pattern of openings may define a spiral or helix of openings that surrounds the outer surface of the wall 107 and extends along the longitudinal axis 106. Each dimension may vary along the length of the elongate body 104 or along the length of certain sections of the elongate body 104, for example, to vary the flexibility and tensile strength of certain sections of the elongate body 104 relative to other sections of the elongate body 104. For example, the opening at the distal end 104A defines a different beam length, spacing, radius of curvature, circumferential offset angle, and/or angular offset angle than the other openings at the proximal end 104B of the elongate body 104.

The distal section 110A of the elongate body 104 can define an increased density of openings relative to a more proximal section (e.g., proximal section 110B) of the elongate body 104 by defining at least a reduced beam length, spacing, and/or angular offset angle between the openings and/or an increased radius of opening curvature relative to the openings on the more proximal section of the elongate body 104. The increased density of openings may provide several material property benefits to the distal section 110A of the elongate body 104. The increased radius of curvature of the openings and the reduced spacing between the openings may increase the tensile strength and torque response of the elongate body 104 while maintaining a low bending stiffness of the distal section 110A. In some examples, the reduced spacing between the openings reduces the bending radius of the distal section 110A and/or reduces the localized strain imposed on any uncut section of the distal section 110A. The distal section 110A may define an opening with a combined reduced beam length and spacing between the openings to reduce the bending stiffness and increase the flexibility of the distal section 110A.

The measurement may vary along the length of the elongate body 104. For example, the proximal section 110B may define an increased density of openings relative to the distal section 110A. The increased density of openings at the proximal section 110B may simplify fabrication of the proximal section 110B, thereby simplifying the overall fabrication complexity and fabrication cost of the elongate body 104.

In some examples, as shown in fig. 1, at least some of the openings are mirror images of one or more other openings on the elongated body 104. For example, the one or more openings define a reflective symmetry of one or more other openings, e.g., the one or more openings are reflections of the one or more other openings across a reflection axis or plane. The reflection axis or plane may be orthogonal to the longitudinal axis 106. The mirror image of one opening may be an opening of the same size with a different orientation. In some examples, the opening is oriented toward one end of the elongated body 104 and a mirror image of the opening is oriented toward an opposite end of the elongated body 104. For example, the open section of the open concave portion is oriented toward one end of the elongated body 104, and the open section of the mirror-image open concave portion is oriented toward the opposite end of the elongated body 104. The longitudinally adjacent openings may be mirror images orthogonal to the longitudinal axis 106 across the reference plane or offset from the longitudinal axis 106 by a predetermined angle. In some examples, the group of openings (e.g., one or more circumferential rows of openings) may be a mirror image of the other groups of openings. Each set of openings may be disposed within one of a plurality of regions defined by the elongate body 104. Each region may be a mirror image of another region of the elongate body 104. As will be described further below, such mirroring of the openings may enable a higher density of openings having a non-linear shape (such as an arcuate shape) while maintaining a minimum distance (e.g., minimum spacing) between the openings, for example, as compared to the same elongated body 104 without mirrored openings.

The distal section 110A includes a distal end 104A of the elongate body 104, and the proximal section 110B includes a proximal end 104B of the elongate body 104. Distal section 110A may have any suitable length. In some examples, the distal section 110A is about 5% to about 50% of the total length of the elongate body 104, such as about 10% to about 40%, about 5% to about 25%, or about 10% to about 25% of the total length of the elongate body 104. In some examples, the distal section 110A may define a length of about 5cm to about 40cm, such as about 5cm to about 35cm, or about 5cm to about 10cm. In some of these examples, the elongate body 104 defines an overall length of about 132 cm. The distal section 110A may be configured to provide a leading end for navigation through the vasculature, while the proximal section 110B may be configured to conform to the changing curvature of the vasculature. As such, the distal section 110A and the proximal section 110B may be configured to have different properties corresponding to different functions of each section.

Atraumatic tip 105 may define a distal-most portion of guidewire 100. Atraumatic tip 105 may be configured to prevent adverse interactions between portions of guidewire 100 (e.g., distal end 104A of elongate body 104) and the patient's tissue as guidewire 100 is navigated through the patient's vasculature. Atraumatic tip 105 may define a blunt and/or hemispherical shape, for example, to prevent unintended penetration of patient tissue. Atraumatic tip 105 may be formed of biocompatible materials including, but not limited to, biocompatible glues, biocompatible polymers, and the like. Atraumatic tip 105 may be coupled to (e.g., permanently attached to) both the elongate body 104 and the distal end of core wire 102. For example, a relatively radially inward portion of the proximal end of atraumatic tip 105 is coupled to the distal tip of core wire 102, and a relatively radially outward portion of the proximal end of atraumatic tip 105 is coupled to the distal end of elongate body 104. Coupling atraumatic tip 105 to both core wire 102 and elongate body 104 may fix the positioning and orientation of elongate body 104 relative to core wire 102, and vice versa, e.g., to prevent unintended rotation and/or separation of elongate body 104 from core wire 102.

In some examples, the outer diameter of the guidewire 100 may be uniform along the length of the guidewire 100. In other examples, the outer diameter of the guidewire 100 may taper from a first outer diameter at the proximal section 102B of the core wire 102 to a second outer diameter at the distal section 102A of the core wire 102, the second outer diameter being less than the first outer diameter. In some examples, the taper may be continuous along the length of the guidewire 100 such that the outer surface of the core wire 102 defines a smooth transition between the portions of different diameters. In some examples, as shown in fig. 1, the distal section 102A tapers to a smaller outer diameter such that when the elongate body 104 is disposed on the reduced diameter portion of the distal section 102A of the core wire 102, the outer diameter of the elongate body 104 defines the same or a smaller outer diameter than the portion of the core wire 102 proximate the proximal end 104B of the elongate body 104. In other examples, the core wire 102 may define a discrete step-wise decrease in outer diameter to define a taper. The discrete progressively decreasing diameter sizes may be selected to reduce the number of edges that may hook onto anatomical features within the vasculature and/or with the catheter as the guidewire 100 is advanced through the vasculature.

The larger diameter proximal section 102B of the core wire 102 may provide better proximal support for the core wire 102 than the smaller diameter proximal section 102B, which may help increase pushability of the guidewire 100. Further, the smaller diameter distal section 102A of the core wire 102 may increase the navigability of the guidewire 100 through tortuous vasculature as compared to the larger diameter distal section 102A. Thus, reducing the outer diameter of the core wire 102 at the distal section 102A may improve the navigability of the guidewire 100 through tortuous vasculature, while still maintaining a relatively high level of proximal pushability, relative to the same core wire 102 defining a larger diameter distal section 102A or defining a uniform outer diameter.

In some examples, at least a portion of the outer surface of the guidewire 100 includes one or more coatings, such as, but not limited to, an anti-thrombogenic coating, an antimicrobial coating, or a lubricious coating that may help reduce in vitro thrombosis. The lubricious coating may be configured to reduce static or dynamic friction between the guidewire 100 and tissue of a patient and/or a catheter holding the guidewire 100 as the guidewire 100 is advanced through the vasculature. The lubricious coating may be, for example, a hydrophilic coating. In some examples, the entire working length of the guidewire 100 (from the atraumatic tip 105 to the proximal section 102B of the core wire 102) is coated with a hydrophilic coating. In other examples, only a portion of the working length of the guidewire 100 is coated with a hydrophilic coating. This may provide a length of the guidewire 100, e.g., at the proximal section 102B, which the clinician may utilize to grasp the guidewire 100 (e.g., the core wire 102), e.g., to rotate the guidewire 100, pull the guidewire 100, or push the guidewire 100 through the vasculature.

Fig. 2A is a conceptual diagram illustrating a side view of an elongate body 104 of the guidewire 100 of fig. 1. The elongate body 104 is disposed at the distal section 103A of the guidewire 100 and surrounds the distal section 102A of the core wire 102 of the guidewire 100. The elongate member 104 includes a wall 107 extending along the longitudinal axis 106 from the distal end 104A to the proximal end 104B. The distal end 104A may be coupled to an atraumatic tip 105. A plurality of openings 108 are provided in the wall 107 of the elongate body 104.

The opening 108 may include a cutout, void, or any other interruption in the wall 107 that alters the ability of at least a portion of the elongate body 104 to compress or expand in response to an external force applied to the elongate body 104. In some examples, at least one of the openings 108 extends from an outer surface 202 of the elongate body 104 to an inner surface of the elongate body 104 defining an interior cavity of the elongate body 104. In some examples, at least one of the openings 108 extends partially from an outer surface of the elongate body 104 toward the lumen of the elongate body 104 without penetrating an inner surface of the elongate body 104 defining the lumen.

The elongate body 104 can define a plurality of longitudinal regions 204A-204N (collectively, "longitudinal regions 204" or "regions 204"). The longitudinal region 204 may extend from the distal end 104A to the proximal end 104B. Each of the regions 204 may be longitudinally adjacent to one or more other ones of the regions 204. For example, region 204B is longitudinally adjacent to and near region 204A and longitudinally adjacent to and distal from region 204C. Each region 204 may include one or more openings 108 or circumferential rows of openings 108 around the outer periphery of the elongated body 104. Different sets of openings 108 may be disposed within the longitudinal regions 204A-204N. Each region 204 may define a different bending stiffness, a different tensile stiffness, or a different torsionality relative to another region 204 (e.g., longitudinally adjacent regions 204) in response to the same type and magnitude of external force. Within each of the regions 204, the size of the openings 108 within the respective region may remain uniform. For example, the openings 108 within a single region 204 may define the same radius of curvature, spacing, beam length, etc. The size of the openings 108 may vary between longitudinally adjacent regions 204. For example, each opening 108 within region 204B may define the same size, and the first opening 108 within region 204B may define a different size than the second opening 108 within region 204A and the third opening 108 within region 204C. In some examples, one or more of regions 204 may be a mirror image of another of regions 204. For example, the openings 108 in a first region may be a mirror image of the openings 108 in a longitudinally adjacent second region across a reference plane between the first and second regions.

Each of the regions 204 may have the same longitudinal length along the longitudinal axis 106. In some examples, at least two of the regions 204 may have different longitudinal lengths. Each region 204 may have the same number of rows of openings 108 and/or the same number of openings 108. In some examples, the one or more regions 204 may include a single opening 108, two openings 108, or a single circumferential row of openings 108. In some examples, at least two of the regions 204 may have a different number of rows of openings 108 and/or a different number of openings 108 within each region 204.

Fig. 2B is a conceptual diagram illustrating a cross-sectional view of the distal section 103A of the example guidewire 100 of fig. 2A, the cross-section being taken along line A-A in fig. 2A. As shown in fig. 2B, the guidewire 100 includes a core wire 102, an elongate body 104, a support member 210, and an atraumatic tip 105. The elongate body 104 can define a lumen 206 and the support member 210 can define a lumen 208. The support member 210 may be disposed within the lumen 206 of the elongate body 104. The distal section 214 of the core wire 102 may be connected to the atraumatic tip 105. The distal section 214 of the core wire 102 may be disposed within the lumen 206 and the lumen 208.

The distal section 110A and the proximal section 110B may have a unitary body construction, for example, may be formed as one body such that the wall 107 of the elongate body 104 is continuous along the entire length of the elongate body 104 such that the elongate body 104 is a single seamless tubular body. The seamless elongate body 104 can, for example, be free of any seams (e.g., seams formed by joining two separate tubular bodies together at an axial location along the longitudinal axis 106) such that the seamless elongate body 104 is a unitary body, rather than a plurality of discrete bodies that are separately formed and subsequently joined together. The seamless elongate body 104 may slide more easily over another device (e.g., a guide member) than an elongate body formed of two or more longitudinal sections mechanically connected to one another because the seamless elongate body may define a smoother lumen. In contrast, the joint between the sections of the elongate body formed by two or more longitudinal sections may define surface protrusions or other irregularities along the lumen, which may interfere with passage of the device through the lumen. In addition, the seamless elongate body 104 can help distribute thrust and rotational forces along the length of the guidewire 100. Thus, the seamless elongate body 104 can help promote pushability of the guidewire 100.

In some examples, the thickness of the wall 107 of the elongate body 104 is substantially constant along the length of the elongate body 104. In other examples, the thickness of the wall 107 varies along the length of the elongated body 104. For example, the thickness of the wall 107 may decrease toward the distal end 104A (e.g., the thickness of the wall 107 may decrease from the proximal end 104B of the elongate body 104 to the distal end 104A, or may decrease from the proximal end of the distal section 110A to the distal end of the distal section 110A). The thickness of the linear wall 107 may increase linearly or non-linearly from the distal end 104A. In some examples, the thickness of the linear wall 107 may decrease linearly or non-linearly from the proximal end 104B and/or from the distal end of the distal section 110A. For example, the thickness of the wall 107 may decrease from about 0.33 millimeters (mm) at the proximal end of the elongate body 104 to about 0.0127mm (about 0.0005 inches) at the distal end of the elongate body 104. However, other wall thicknesses may be used in other examples, and may depend on the particular procedure in which the guidewire 100 is used.

In some examples, the elongate body 104 may define the same outer diameter along the length of the elongate body 104 as the thickness of the wall 107 varies along the length of the elongate body 104. In such examples, the inner diameter of the lumen 206 may vary along the length of the elongate body 104, for example, to maintain the same outer diameter. In some examples, the lumen 206 may define the same inner diameter along the length of the elongate body 104 as the thickness of the wall 107 varies along the length of the elongate body 104. In some examples, both the outer diameter of the elongate body 104 and the inner diameter of the lumen 206 may vary as the thickness of the wall 107 varies along the length of the elongate body 104.

In the example of fig. 2B, the opening 108 extends through the entire thickness of the wall 107 (measured in a direction perpendicular to the longitudinal axis 106 of the guidewire 100, which may also be the longitudinal axis of the elongate body 104). In other examples, the opening 108 extends partially through the wall 107. For example, the opening 108 may extend from the outer surface of the elongate body 104 toward the lumen 206 of the elongate body 104 but not reach the lumen. The depth of the partial opening 108 may be described as a percentage of the thickness of the wall 107 or as units of length (e.g., millimeters). In some examples, the depth of the partial opening 108 may be about 20% to about 80% of the thickness of the wall 107, such as about 50% to about 75% of the thickness of the wall 107. In contrast, the through opening 108 may extend through 100% of the thickness of the wall 107.

In examples where the opening 108 includes a plurality of partial openings, each partial opening 108 may have a substantially similar depth, or at least two of the partial openings 108 may have different depths. For example, each of the partial openings 108 may have the same depth as measured in units of length. As another example, the unit length of the depth of the partial opening 108 may be different, but the depth measured as a percentage of the thickness of the wall 107 may be the same. If the elongate body 104 is stretched during the manufacturing process, the partial openings 108 at the more distal sections of the elongate body 104 may have a depth less than the depth of the more proximal openings 108, however, the thickness percentages of the depths of the two openings 108 may be substantially the same (e.g., equal to or within 5% of each other). In some examples where the opening 108 is a partial opening, the opening 108 extends from an outer surface of the wall 107 toward the lumen 206, where the outer surface may be the surface closest to the outer sheath or other outer layer or surface of the guidewire 100. In these examples, the inner surface of the elongate body 104 defining the lumen 206 may be relatively smooth, which may help facilitate passage of the medical device through the lumen 206. For example, the guide member may not catch on the opening 108 as it traverses through the lumen 206 from the proximal end of the guidewire 100 toward the distal end of the guidewire 100. In other examples, the opening 108 may extend from an inner surface toward an outer surface of the wall 107 defining the lumen 206. For example, the angular orientation of the opening relative to an axis extending normal to the longitudinal axis 106 may be selected to minimize the likelihood of the guide member hooking onto the opening.

In some examples, the opening 108 may be elliptical or define a concave portion. The elliptical opening may comprise, for example, an elongated rectangle, an elongated oval, an ellipse, or another elongated polygonal shape (e.g., an elongated trapezoid, an elongated quadrilateral, an elongated pentagon, an elongated octagon, etc.). The depth, length, and/or width of the opening 108 may be defined, at least in part, by or may define, at least in part, the beam length, offset angle, spacing, and/or radius of curvature of the opening 108.

Portions of the elongate body 104 may define a density of openings 108, which may be the number of openings 108 per unit length of the elongate body 104 (the length being measured in a direction along the longitudinal axis 106). The density of the openings 108 may be based on the length and/or width of each opening 108, and/or the beam length, spacing, angular offset angle, and/or radius of curvature of the opening 108. For example, as shown in fig. 2A, longitudinally adjacent rows of openings 108 that exhibit reflective symmetry may increase the density of openings 108, for example, by reducing the amount of space between longitudinally adjacent rows.

In some examples, the density of the openings 108 may be uniform along the length of the elongate body 104. In some examples, the density of the openings 108 may vary along the length of the elongate body 104. For example, the density of the openings 108 may increase in the distal direction such that there are more openings 108 near the distal end 104A of the elongate body 104 than near the proximal end 104. In these examples, for an otherwise identical elongate body 104, the distal section 110A of the elongate body 104 may have a greater bending flexibility than the proximal section 110B of the elongate body 104. As another example, the density of the openings 108 may decrease in the distal direction such that fewer openings 108 are near the distal end 104A of the elongate body 104 than near the proximal end 104.

The density of the openings 108 may increase as one or more of the beam length between the openings 108, the spacing between the openings 108, the length of each opening 108, and/or the width of each opening 108 decreases. In some examples, the density of the openings 108 may increase as the radius of curvature of the openings 108 increases. Conversely, the density of the openings 108 may decrease as one or more of the beam length, spacing, length, and/or width of the openings 108 increases and/or as the radius of curvature of the openings 108 decreases.

The density of the openings 108 on the elongate body 104 can be about 4% to about 30% (e.g., such as about 5% to about 25%, about 11% to about 19%, or about 14%). The 4% density of the openings 108 indicates that at a particular portion of the elongated body 104 (e.g., region 204N), the openings 108 cover 4% of the surface area of the particular portion of the elongated body 104 (e.g., 4% of the surface area of the region 204N of the elongated body 104). That is, about 4% to about 30% of the elongate body 104 may be cut. The percentage of the elongated body 104 that is cut may be, for example, an area percentage of the outer surface of the elongated body 104.

The opening 108 may be formed in the elongate body 104 using one or more techniques. In some examples, the openings 108 may be etched, laser cut, or mechanically cut into a tubular body or other material forming the elongated body 104 via a blade, a router, an abrasive disk, or the like. In other examples, the elongate body 104 may be formed by wrapping an elongate body ribbon (e.g., PTFE) around the bead. As another example, the elongated body 104 may be formed using an additive manufacturing process (also referred to as a three-dimensional printing technique in some examples). The opening 108 may then be defined during additive manufacturing.

The support member 210 is configured to increase the structural integrity of the guidewire 100 while allowing the guidewire 100 to remain relatively flexible. For example, the support member 210 may be configured to help the guidewire 100 substantially maintain its cross-sectional shape, or at least to help prevent the guidewire 100 from buckling or kinking as it navigates through tortuous anatomy. In some examples, the guidewire 100 may include another layer, such as a support layer, that adheres the support member 210 to the elongate body 104. The support member 210, along with the elongate body 104, can help distribute thrust and rotational forces along the length of the guidewire 100, which can help prevent the guidewire 100 from kinking when the guidewire 100 is rotated, or from buckling when thrust is applied to the core wire 102. Thus, the clinician may apply a pushing force, a rotating force, or both, to the proximal section 103B of the guidewire 100, and such force may distally advance, rotate, or both, respectively, the distal section 103A of the guidewire 100. The support member 210 can define a lumen 208 configured to retain a distal section 214 of the core wire 102.

In the example of fig. 2B, the support member 210 extends along only a portion of the length of the core wire 102. For example, the proximal end of the support member 210 may be positioned distal to the proximal end 104B of the elongate body 104. The outer diameter of the core wire 102 may decrease from the proximal section 103B to the atraumatic tip 105, e.g., to allow placement of the distal section 214 in the lumen 206 of the elongate body 104 and the lumen 208 of the support member 210, without increasing the outer diameter of the distal section 103A of the guidewire 100.

In some examples, the support member 210 includes a generally tubular braided structure, a coil member defining a plurality of turns, for example, in a helical shape, or a combination of braided and coil members. Thus, in some other examples, although examples of the present disclosure describe support member 210 as a coil, the catheter bodies described herein include a braided structure and no or other than a coil. For example, the proximal section of the support member 210 may comprise a braided structure, and the distal section of the structural support member 210 may comprise a coil member. The support member 210 may be made of any suitable material, such as, but not limited to, a metal (e.g., nickel titanium alloy (nitinol) or stainless steel), a polymer, a fiber, or any combination thereof.

The support member 210 may be coupled, adhered, or mechanically connected to at least a portion of the inner surface of the elongate body 104, such as via a support layer. The support layer may be a thermoplastic or thermoset material, such as a thermoset polymer or thermoset adhesive. In some cases, the material forming the support layer may have elastic properties such that there may be a tendency for the support layer to return to a rest position. In some examples, the support layer is positioned between the entire length of support member 210 and the elongate body 104. In other examples, the support layer is positioned only between a portion of the length of support member 210 and the elongate body 104.

Fig. 3A is a conceptual diagram illustrating an example opening 108 of the elongated body 104 of fig. 2A. As shown in fig. 3A, the opening 108 may have a non-linear shape from the first end 205A through the center 205C to the second end 205B. The nonlinear shape may include an arc (e.g., a semicircular arc, a parabolic arc, an elliptical arc). For each opening 108, the arc length 224 (e.g., the distance along the length of the arc from the first end 205A to the second end 205B) is greater than the chord length 223 (e.g., the linear distance between the first end 205A and the second end 205B). Each arc may include a center point 203 defining a radial center of a circle, parabola, or ellipse that defines an arc of opening 108.

For each opening 108, an arc may extend from the first end 205A through the center 205C to the second end 205B. The center 205C defines a halfway point along the arc and may be equidistant (e.g., linearly, along the length of the arc) from both the first end 205A and the second end 205B. The first end 205A and the second end 205B may have the same longitudinal positioning relative to the longitudinal axis 106, and the center 205C may have a different longitudinal positioning than the first end 205A or the second end 205B.

In some examples, each arc may define a concave portion extending from the first end 205A through the center 205C of the arc to the second end 205B. The concave portion of the arc may face (i.e., in a direction 217 perpendicular to the tangential axis 215 of the center 205C of the arc) the distal end 104A or the proximal end 104B of the elongate body 104 along the longitudinal axis 106, e.g., such that the long axis 304 of the arc is orthogonal to the longitudinal axis 106. Each arc may define a central angle 209 (e.g., relative to the center 203 of the circle, ellipse, or parabola defined by the arc) from the first end 205A to the second end 205B. The center angle may be up to about 180 degrees.

Each opening 108 defines an arc defining a radius of curvature 207. Radius of curvature 207 may be related to an axial span 221 (distance along axis 106) and a circumferential span (distance about axis 106) of the corresponding opening 108 (e.g., chord 223 of opening 108). The radius of curvature 207 for a given chord 223 of the opening 108 may define the axial span 221 of the opening 108 and vice versa. The radius of curvature 207 for a given axial span may define the chord 223 of the opening 108 and vice versa. For example, a larger radius of curvature 207 for an opening 108 having a particular chord 223 may define a smaller axial span 221 than an opening 108 having the same chord 223 and a lower radius of curvature 207. The radius of curvature 207 of the opening 108 may affect the tensile strength and/or torque response of the elongate body 104. The radius of curvature of the opening 108 may allow for increased axial spacing (e.g., along the longitudinal axis 106) over a linear opening that is orthogonal to the longitudinal axis 106. Thus, combining the increased radius of curvature of the openings 108 and the reduced spacing between the openings 108 may increase the tensile strength of the elongated body 104 while maintaining the bending stiffness and torque responsiveness of the elongated body 104. In contrast, an elongated body having a linear opening orthogonal to the longitudinal axis of the elongated body will define a reduced bending stiffness due to the increased tensile strength, thereby reducing the flexibility and bending radius of the elongated body, e.g., as compared to the elongated body 104.

The radius of curvature 207 of the opening 108 may vary between the distal end 104A and the proximal end 104B. As described above, different portions of the elongate body 104 may be configured to provide different functions, and the radius of curvature 207 may be varied to provide characteristics for those particular functions, such as varying bending flexibility or tensile strength.

In some examples, the change in radius of curvature 207 may be linear or non-linear. As one example, the radius of curvature 207 may vary at a linear rate relative to the distance along the longitudinal axis 106. As another example, the radius of curvature 207 may vary at a non-linear rate (e.g., at an exponential rate, at a logarithmic rate) relative to the distance along the longitudinal axis 106. In some examples, the change in radius of curvature 207 may be continuous or discrete along the elongate body 104. As one example, the radius of curvature 207 may vary continuously along the length of the elongate body 107 such that each opening may have a different radius of curvature than an adjacent opening along the longitudinal axis. As another example, the radius of curvature 207 of the opening 108 may vary along a particular portion of the elongated body 104 that is separated by other portions of the elongated body 104 that include the opening 108 defining a uniform radius of curvature 207. In some examples, the opening 108 at the proximal section 110B of the elongate body 104 defines a smaller or larger radius of curvature than the opening 108 at the distal section 110A of the elongate body 104. The opening 108 defining the larger radius of curvature 207 may define a greater angle 209 than the opening 108 defining the smaller radius of curvature 207. The openings 108 defining a smaller radius of curvature 207 may reduce the flexibility of the elongated body 104 about the respective openings 108 relative to the openings 108 defining the same chord 223 of the larger radius of curvature 207. The distal section 110A of the elongate body 104 can define an opening 108 that defines a larger radius of curvature than the proximal section 110B of the elongate body 104, for example, to increase flexibility of the distal section 110A relative to the proximal section. The radius of curvature 207 of the opening 108 may be about 0.3 millimeters (mm) to about 3mm (e.g., about 0.012 inches (in) to about 0.12 in).

Fig. 3B is a conceptual diagram illustrating another example opening 108 of the elongate body 104 of fig. 2A. The opening 108 may define a reference axis 211B that extends linearly from the first end 205A to the second end 205B. The opening 108 may be offset from the longitudinal axis 106, for example, such that the reference axis 211B is offset from the reference axis 211A by an angle 213. The reference axis 211A is orthogonal to the longitudinal axis 106. The angle 213 may be up to about 90 degrees. Offsetting the opening 108 from the longitudinal axis 106, such as in the manner shown in fig. 3B, may inhibit preferential bending of the elongate body 104 along a particular plane in response to external forces on the elongate body 104.

Fig. 3C is a conceptual diagram illustrating an example of the elongate body of fig. 2A, the elongate body having been cut longitudinally and laid flat. The openings 108 may be in circumferential rows 234A, 234B (collectively referred to herein as "circumferential rows 234", "rows 234") around the circumference of the elongate body 104. As shown in fig. 3C, each row 234 of openings 108 may include two openings 108. In some examples, each row of openings 234 includes one opening 108 or three or more openings 108. Circumferentially adjacent openings 108 of each row 234 are separated by an uncut portion of wall 107. As shown in fig. 3C, each row 234 includes two uncut portions of wall 107. The opening 108 may be offset from the longitudinal axis 106 in a clockwise direction as shown in fig. 3B (i.e., angle 213 extends from reference axis 211A to reference axis 211B in a clockwise direction). In some examples, the opening 108 is offset from the longitudinal axis 106 in a counterclockwise direction (i.e., the angle 213 extends from the reference axis 211A to the reference axis 211B in a counterclockwise direction).

Each row 234 of openings 108 may define circumferentially adjacent openings 108 on a reference plane. The reference plane may be the longitudinal axis 106 or perpendicular to the longitudinal axis. In some examples, the reference plane may be offset from a plane perpendicular to the longitudinal axis 106 by an angle of up to about 90 degrees (e.g., about 45 degrees, about 75 degrees, about 80 degrees). Each row 234 of openings 108 may be longitudinally adjacent to one or more other rows of openings 108. For example, as shown in fig. 3C, each circumferential row 234A is longitudinally adjacent to at least one circumferential row 234B and longitudinally alternates with another circumferential row 234A. In some examples, each row of openings 108 may be directly adjacent to two other rows of openings 108 along the longitudinal axis 106. For example, as shown in fig. 3C, each circumferential row 234A is immediately adjacent to at least one circumferential row 234B and is not immediately adjacent to any other circumferential row 234A. As described in this disclosure, two longitudinally adjacent rows of openings 108 have no other row of openings 108 between the two rows, which are "directly adjacent".

Circumferentially adjacent openings 108 within each row are separated by uncut portions of wall 107. Each uncut portion of wall 107 may be defined by a beam length 228. The beam length 228 corresponds to the length of a corresponding uncut portion of the wall 107 around the circumference of the elongate body 104. For example, a first end 205A of one opening 108 is separated from a second end 205B of a circumferentially adjacent opening 108 by a beam length 228. A larger beam length 228 value may increase the tensile strength of the elongated body 104 relative to the elongated body 104 having the same opening 108 with a smaller beam length 228 value. The smaller beam length 228 value may increase the torque responsiveness of the elongated body 104 relative to the elongated body 104 having the same opening 108 with the larger beam length 228 value. The beam length 228 may vary along the length of the elongate body 104, such as from the distal end 104A to the proximal end 104B. For example, as shown in fig. 2A, the beam length 228 may increase from the distal end 104A to the proximal end 104B. The beam length 228 of the opening 108 may include a minimum beam length value, for example, such that a portion of the elongate body 104 defines a minimum tensile strength that exceeds or equals a threshold minimum tensile strength desired by a clinician.

Longitudinally alternating rows 234 of openings 108 may be separated by a spacing 226. For example, each circumferential row 234B of openings 108 is separated from longitudinally alternating circumferential rows 234B of openings 108 by a spacing 226. The smaller spacing 226 may reduce the bending radius and/or bending stiffness of the elongated body 104 relative to another elongated body 104 having the same openings 108 separated by the larger spacing 226. The larger spacing 226 may increase the pushability of the elongated body 104 relative to another elongated body 104 having the same openings 108 separated by the smaller spacing 226. The spacing 226 may vary along the length of the elongate body 104, such as from the distal end 104A to the proximal end 104B. For example, as shown in fig. 2A, the spacing 226 of the openings 108 increases from the distal end 104A to the proximal end 104B, e.g., to reduce the bending stiffness and bending radius of the distal section 110A of the elongate body 104 relative to the proximal section 110B of the elongate body 104.

The rows 234 of openings 108 may define a repeating pattern 235 along the elongate body 104. The repeating pattern 235 may define a helix or spiral along the longitudinal length of the elongate body 104. For example, the circumferential row 234A of openings 108 may define a first helix or spiral along the longitudinal length of the elongate body 104, and the circumferential row 234B of openings 108 may define a second helix or spiral along the longitudinal length of the elongate body 104. Each spiral or helical thread may define a plurality of coils, each defined by a separate circumferential row 234 of openings 108. The spacing between longitudinally adjacent coils of the spiral or helical thread may vary along the longitudinal length of the elongate body 104, for example, based on the variation in the spacing 226 between the openings 108 of the circumferential rows 234.

Each row 234 of openings 108 may be offset circumferentially by an angle 230 from the offset angle of the adjacent repeating pattern 235 of the corresponding row 234. For example, as shown in fig. 3C, each circumferential row 234B is offset from a longitudinally adjacent circumferential row 234B by an angle 230. The angular offset angle 230 may define a pitch of spirals or rotations of the repeating pattern 235, e.g., a pitch of spirals or spirals. Each repeating pattern 235 may include two or more rows 234 of openings 108. In some examples, the repeating pattern 235 may include a first circumferential row 234A of openings 108 and a second circumferential row 234B of openings 108, wherein the second circumferential row 234B of openings 108 is a mirror image of the first circumferential row 234A of openings 108 across the reference plane 236. The reference plane 236 may be orthogonal to the longitudinal axis 106, or may be similar or identical to the reference axis 211A, as shown in fig. 3B. In some examples, the corresponding circumferential row 234 openings 108 of adjacent repeating patterns 235 may be longitudinally alternating circumferential rows 234A openings 108 of adjacent repeating patterns 235 relative to the first circumferential row 234A openings 108. Each repeating pattern 235 may define a constant angular offset angle 230 or a varying angular offset angle 230. For example, as shown in fig. 2A, the repeating pattern 235 of openings 108 defines an increasing angular offset angle 230 from the distal end 104A to the proximal end 104B. The angular offset angle 230 may be about 4 degrees to about 14 degrees.

Each pattern 235 in the repeating pattern 235 may have a different size. One pattern 235 may include openings 108 that define a different pitch 226, radius of curvature 207, beam length 228, and/or angular offset angle 230 than the openings 108 of an adjacent pattern 235. For example, the first repeating pattern 235 includes openings 108 that define a smaller pitch 226, a smaller beam length 228, a larger radius of curvature 207, and a smaller angular offset angle 230 than the openings 108 of the second repeating pattern 235 that are closer to the first repeating pattern 235, and vice versa. In some examples, the first repeating pattern 235 includes openings 108 having the same or similar chord 223, smaller arc 224, and smaller axial span 221 as the openings 108 in the second repeating pattern 235. The elongated body 104 may define the same repeating pattern 235 along the length of the elongated body 104, or may define two or more different repeating patterns 235 along the length of the elongated body 104. Each of the two or more different repeating patterns 235 may define a different spiral or helix.

The pattern 235 may define a spatial arrangement of the openings 108 along (e.g., axially) and/or about (e.g., circumferentially) the axis 106. Each pattern 235 may be internally symmetrical or asymmetrical. For example, the openings 108 within each row 234 of openings 108 in the pattern 235 may be symmetrically arranged with respect to the longitudinal axis 106 to define radial symmetry. The openings 108 may define other types of symmetrical patterns 235 including, but not limited to, reflective symmetry (e.g., mirror image openings 108), rotational, sliding reflective, or spiral symmetry. For example, as shown in fig. 3C, the openings 108 of each circumferential row illustrate radial symmetry. For example, as shown in fig. 3C, the openings 108 of the first circumferential row 234A exhibit slip reflection symmetry and reflection symmetry relative to the openings 108 of the second circumferential row 234B. In some examples, the elongate body 104 can define a symmetrical opening along a portion of the distal section 103A and an asymmetrical opening along a different portion of the distal section 103A.

The pattern 235 may be repeated along the length of the elongate body 104. The repeating pattern 235 may collectively define a helical or spiral arrangement of openings extending at least partially along the elongate body 104. The same opening 108 of the repeating pattern 235 may define a first spiral or helix having a first pitch of rotation in one direction (e.g., in a clockwise direction) and a second spiral or helix having a second pitch of rotation in a second direction (e.g., in a counter-clockwise direction).

Each row 234 of openings 108 may be circumferentially offset from a longitudinally adjacent row 234 of openings by a circumferential offset angle 232. For example, each circumferential row 234A is circumferentially offset from a longitudinally adjacent circumferential row 234B by a circumferential offset angle 232. For example, the centers 205C of the openings 108 on a first circumferential row 234A are circumferentially offset from the corresponding openings 108 on a second circumferential row 234B longitudinally adjacent to the first circumferential row 234A. Longitudinally adjacent rows 234 may be circumferentially offset by a circumferential offset angle 232 of about 90 degrees plus one half of the angular offset angle 230, e.g., to prevent any portion of the elongated body 104 from preferentially bending along any particular plane. For example, if the angular offset angle 230 between two longitudinally adjacent circumferential rows 234A is 14 degrees, then the circumferential offset angle 232 between one of the two circumferential rows 234A and the circumferential row 234B between the two circumferential rows 234A is 97 degrees. As another example, if the angular offset angle 230 between two longitudinally adjacent circumferential rows 234B is 4 degrees, then the circumferential offset angle 232 between one of the two circumferential rows 234B and the circumferential row 234A between the two circumferential rows 234B is 92 degrees. As the angular offset angle 230 between the repeating pattern 235 of openings 108 varies along the length of the elongate body 104 (e.g., increases from the distal end 104A toward the proximal end 104B), the circumferential offset angle 232 between longitudinally adjacent ones 234 of the rows 234 defining the repeating pattern 235 of openings 108 may vary accordingly.

In some examples, longitudinally adjacent rows 234 of openings 108 may be mirror images about a reference plane 236 that is orthogonal to the longitudinal axis 106 or offset from the longitudinal axis 106 by an angle (e.g., angle 213). The mirroring of the rows 234 of openings 108 may reduce the spacing 226 between longitudinally alternating rows 234 of openings 108 along the longitudinal axis 106, thereby increasing the density of openings 108 along a set length of the elongated body 104 as compared to the same set length on the same elongated body 104 without any mirrored rows 234 of openings 108. The increased density of openings 108 increases the flexibility of the elongated body 104 relative to the same elongated body 104 without any mirrored rows 234 of openings 108.

In some examples, the dimensions (e.g., pitch, radius of curvature, beam length, angle of angular offset, reflection symmetry) of the opening 108 may vary (e.g., linearly or non-linearly) between the distal end 104A and the proximal end 104B. The opening 108 may define a change in the size of the opening 108 from the distal end 104A to the proximal end 104B. For example, the radius of curvature 207 of the first opening 108 is greater than the radius of curvature 207 of the second opening 108 proximate the first opening 108. In some examples, the radius of curvature 207 of the first opening 108 and the second opening 108 is greater than the radius of curvature 207 of the third opening 108 proximate to the second opening 108.

One row 234 of openings 108 may be separated from a first longitudinally adjacent row 234 of openings 108 by a first spacing and from another longitudinally adjacent row 234 of openings 108 by a second spacing different from the first spacing. For example, a row 234A of openings 108 may be separated from a longitudinally adjacent and proximal row 234B of openings 108 by a first spacing and from a longitudinally adjacent and distal row 234B of openings 108 by a second spacing. In such examples, the spacing 226 between longitudinally alternating rows 234 may be a sum of the first spacing and the second spacing. Longitudinally adjacent rows 234 may be separated by a distance that alternates between a first pitch and a second pitch. The non-uniform spacing between longitudinally adjacent rows 234 may increase the tensile stiffness of the elongate body 104 without reducing the torque responsiveness of the elongate body 104.

Within each region 204, the first pitch may define a uniform longitudinal distance and the second pitch may define another uniform longitudinal distance. For example, within the example region 204, the first spacing may be about 0.15mm (e.g., about 0.006 in) and the second spacing may be about 0.20mm (e.g., about 0.008 in). In some examples, within each region 204, the first pitch and the second pitch may define a variable longitudinal distance. The first and second pitches may increase or decrease from the distal end 104A to the proximal end 104B. For example, the first spacing between the rows 234 at or about the distal end 104A is less than the first spacing between the rows 234 at or about the proximal end 104B, and vice versa.

Fig. 3D is a conceptual diagram illustrating another example of the elongate body of fig. 2A, the elongate body having been cut longitudinally and laid flat. As shown in fig. 3D, two or more longitudinally adjacent rows 234 of openings 108 may define a set 238A, 238B (collectively referred to herein as "set 238") of rows 234. The rows 234 within each group 238 may be of the same type. For example, group 238A includes only circumferential row 234A and group 238B includes only circumferential row 234B. One group 238A may be a mirror image of another group 238B on the reference plane 236. The mirrored set 238 of rows 234 may increase the density of openings 108 along a set portion of the elongated body 104 relative to another elongated body 104 without the mirrored set 238 of rows 234.

Fig. 4 is a conceptual diagram illustrating a distal section 110A of the elongate body 104 of fig. 1. Fig. 5 is a conceptual diagram illustrating a proximal section 110B of the elongate body 104 of fig. 1. As shown in fig. 4 and 5, the openings define varying radii of curvature and reflective symmetry. In some examples, the opening on the elongated body 104 may define a varying radius of curvature or reflective symmetry. Further, while the openings shown in fig. 4 and 5 define arcs, examples described below may include openings defining other shapes.

As shown in fig. 4, the openings 108 may include a first set of openings 108 ("openings 302A") and a second set of openings 108 ("openings 302B"). Similarly, as shown in fig. 5, the openings 108 may include a first set of openings ("openings 402A") and a second set of openings ("openings 402B"). In some examples, opening 302B may have a different size than opening 302A, and opening 402B may have a different size 402A. In some examples, the opening 302B may be a mirror image of the opening 302A (e.g., with respect to a reference plane perpendicular to the longitudinal axis 106). In some examples, the opening 402B may be a mirror image of the opening 402A (e.g., with respect to a reference plane perpendicular to the longitudinal axis 106). In some examples, opening 302A may be the same as opening 302B and/or opening 402A may be the same as opening 402B.

In some examples, the openings 302A, 302B, 402A, and 402B may each define a different repeating pattern of openings 235. In some examples, the one or more rows of openings 302A and the one or more rows of openings 302B may define a first repeating pattern 235, and the one or more rows of openings 402A and the one or more rows of openings 402B may define a second repeating pattern 235. In some examples, the rows of openings 302A and the rows of openings 302B may define a repeating pattern 235, and the openings 402A, 402B may define the same repeating pattern 235, e.g., having different dimensions (e.g., different lengths, widths, depths, beam lengths, spacing, angular offset angles, radii of curvature).

As shown in fig. 4, each of the openings 302A, 302B (collectively "openings 302") defines an arc. For each of the openings 302, an arc may extend from the first end, through the center, and terminate at the second end. For each of the openings 302, the first and second ends may have a first longitudinal orientation relative to the longitudinal axis 106 and may have a different longitudinal orientation than the center. Each arc defined by the opening 302 defines a concave portion that extends toward the distal end of the elongate body 104 (distal end 104A of fig. 1, 2A, or 2B) or toward the proximal end of the elongate body 104 (proximal end 104B of fig. 1, 2A, or 2B). For example, as shown in fig. 4, the opening 302A defines a concave portion extending toward the proximal end 104B, and the opening 304B defines a concave portion extending toward the distal end 104A. Each of the openings 304B may be a mirror image of one or more of the openings 304A.

Openings 302A and 302B may define rows of similar openings, each circumferential row extending around the perimeter of elongated body 104. For example, each row of similar openings may entirely include opening 302A or opening 302B. The multiple rows of openings 302 may be directly adjacent to one another, for example, wherein the multiple rows of openings 302 are not separated by a third row of openings 302 along the longitudinal axis 106. In some examples, the rows of openings 302 may alternate longitudinally (also referred to herein as "longitudinally alternating rows"), for example, wherein the rows of openings 302 are separated along the longitudinal axis 106 by a third row of openings 302.

In some examples, longitudinally adjacent rows of similar openings (e.g., openings 302A) may be separated by two or more rows of different openings (e.g., openings 302B). For example, each row of openings 302B may be directly adjacent to a row of openings 302A and a row of openings 302B. In such examples, each row of openings 302B may be a mirror image of a directly adjacent row of openings 302A. Within each row of openings 302, the openings 302 are disposed about the perimeter of the elongated body 104. The openings 302 may be symmetrically or asymmetrically disposed about the perimeter. Each row may include a plurality of openings 302, such as two or more openings 302.

Longitudinally adjacent rows of openings 302 may be circumferentially offset from one another. For example, each opening 302 in each row of openings 302 is circumferentially offset from a longitudinally adjacent opening 302 in a longitudinally adjacent row of openings 302. Alternatively, longitudinally adjacent rows of openings 302 may be offset from one another about the circumference of the elongate body 104. The offset of longitudinally adjacent rows of openings 302 may prevent preferential bending of the elongated body 104 along a particular plane. The center of each opening 302 may be offset from the center of a longitudinally adjacent opening 302 by a circumferential offset angle of 90 degrees plus half the angular offset angle between the repeating patterns 235 of openings 302 in the circumferential direction. For example, the angular offset angle between the repeating pattern 235 of openings 302 is about 4 degrees to about 14 degrees, and the circumferential offset angle of longitudinally adjacent rows of openings 302 is about 92 degrees to about 97 degrees.

The distal section 110A of the elongate body 104 can include one or more of the regions 204, such as region 204A. The regions 204 may be configured with openings 302 or rows of openings 302 having different parameters such that different regions 204 may have different characteristics, such as bending flexibility. For example, the particular region 204 may have characteristics suitable for the particular function of the particular region 204 at a location on the elongate body 104, or may provide a transition between adjacent regions 204. Each region 204 may include one or more rows of openings 302A and/or one or more rows of openings 302B. In some examples, as shown in fig. 4, region 204A includes multiple rows of openings 302A and multiple rows of openings 302B. In some examples, the region 204A may include a single row of openings 302A and a single row of openings 302B. In some examples, the region 204A may include two or more rows of openings 302A, and the longitudinally adjacent region (e.g., region 204B) may include two or more rows of openings 302B. In such examples, region 204B may be a mirror image of region 204A.

Each of the openings 302 may be defined by a length 306, an axial span 307, and a depth (not labeled). The axial span 307 of each opening 302 may be measured along the longitudinal axis 106, for example, from the center of each opening 302 to the ends of the openings 302. The length 306 may be measured along an axis perpendicular to the longitudinal axis 106. The length 306 and axial span 307 may vary along the length of the distal section 110A and/or within each region 204. In other examples, length 306 and axial span 307 may be the same within each of regions 204.

The length 306 may be measured from a first end of each opening 302 to a second end of the opening 302. Length 306 may be a linear length (also referred to as a "chord length") from a first end to a second end or an arc length along opening 302 from a first end to a second end. At the distal-most section of distal section 110A, each opening 302 may be substantially straight (e.g., such that the chord length and arc length of openings 302 are the same). The axial span 307 of each opening 302 may be determined based on the length 306 and the radius of curvature 310 of each opening 302. The depth may be measured from an outer radial limit of the opening 302 to an inner radial limit of the opening 302. For example, for an opening extending through wall 107, the depth may be the distance between the outer surface of wall 107 and the inner surface of wall 107. For another example, for an opening that does not extend through wall 107, the depth may be the total distance between the outer surface of wall 107 and the inner surface of wall 107 that does not include the material of wall 107.

Within each row of openings 302, circumferentially adjacent openings 302 are separated by a beam length 312. The beam length 312 may be an uncut length of the elongate body 104 between circumferentially adjacent openings 302. For example, a first end of one of the openings 302 is separated from a second end of a circumferentially adjacent opening 302 by a beam length 312. The beam length 312 may vary along the elongate body 104. Increasing the beam length 312 may increase the tensile strength, torque responsiveness, and pushability of the elongate body 104. Reducing the beam length 312 may increase the flexibility of the elongated body 104. The beam length 312 may increase from the distal end of the distal section 110A (e.g., the distal end 104A) toward the proximal end of the distal section 110A, e.g., to increase the flexibility of the distal section 110A. In some examples, the distal-most section of the elongate body 104 may include a row of openings 302 that define a greater beam length 312 than a more proximal row of openings 302 in the distal section 110A, e.g., to increase the stiffness of the distal-most section of the elongate body 104. In some examples, the openings 302 in each region 204 may define the same beam length 312. In some examples, the mirror row of openings 302 may define the same beam length 312.

The longitudinally alternating rows of openings 302 may be separated by a spacing 308. The spacing 308 may be measured as a longitudinal distance along the longitudinal axis 106. The spacing 308 may be measured relative to the same location (e.g., center, first end, second end) on the corresponding opening 302. The spacing 308 may vary along the length of the elongate body 104, for example, to increase stiffness or flexibility at particular sections of the elongate body 104. The larger spacing 308 may increase the bending stiffness and/or bending radius of the elongate body 104, thereby increasing pushability along the length of the guidewire 100. The smaller spacing 308 may reduce the bending stiffness and/or bending radius of the elongate body 104, thereby increasing the flexibility of a portion of the elongate body 104. The change in pitch 308 may be linear or non-linear.

The spacing 308 may increase from the distal end of the distal section 110A toward the proximal end of the distal section 110A, e.g., to increase flexibility along the distal section 110A. In some examples, the spacing 308 of the rows of openings 302 at the distal-most section of the distal section 110A may be greater than the spacing 308 between more proximal rows of openings 302 in the distal section 110A, e.g., to increase the stiffness of the distal-most section of the distal section 110A of the elongate body 104. In some examples, the rows of openings 302 in each of the regions 204 may be separated by the same spacing 308, and the rows of openings 302 in different regions 204 may be separated by different spacing 308.

As shown in fig. 4, the rows of openings 302A and 302B of each pair may form a pattern 311 of repeating units representing the overall pattern of the elongated body 104. Within each pattern 311, the openings 302A and 302B are mirror images of each other, and are circumferentially offset by an angle of up to 90 degrees. The plurality of patterns 311 may define a helix or spiral along the length of the elongate body 104. In some examples, the pattern 311 may define a first spiral or helix in one direction (e.g., in a clockwise direction) and a second spiral or helix in another direction (e.g., in a counter-clockwise direction). The spiral or helical thread may be defined by a spiral or pitch of rotation. The helical pitch may be constant along the length of the elongate body 104 or may vary from the distal end to the proximal end of the distal section 110A. In some examples, the helical pitch may increase from the distal end to the proximal end of the distal section 110A.

Longitudinally adjacent patterns 311 may be offset by an angle 304. Two corresponding openings 302 of two longitudinally adjacent patterns 311 (e.g., two corresponding openings 302A as illustrated in fig. 4) may define an angular offset angle 304. For example, the circumferential offset between the centers, first ends, and/or second ends of two corresponding openings 302 may define an angular offset angle 304. The angular offset angle 304 may be up to 15 degrees, for example up to 10 degrees. In some examples, offset angle 304 is about 4 degrees to about 14 degrees. The angular offset angle 304 may vary (e.g., linearly or non-linearly) along the length of the distal section 110A. For example, the angular offset angle 304 may decrease from the distal end to the proximal end of the distal section 110A. In some examples, the angular offset angle 304 may be about 7.75 degrees to about 10 degrees.

The angular offset angle 304 may control the circumferential offset angle between longitudinally adjacent rows of openings 302 (e.g., within the same pattern 311 defining the angular offset angle 304). The circumferential offset angle may be about 90 degrees plus half the angular offset angle 304. For example, if the angular offset angle 304 is 14 degrees, the circumferential offset angle between longitudinally adjacent rows of openings 302 of the pattern 311 defining the angular offset angle 304 is 97 degrees.

Each of the openings 302 may define a radius of curvature 310. The larger radius of curvature 310 reduces the curvature of the opening 302, which may maintain or improve the torque responsiveness of the elongate body 104 as compared to elongate bodies including openings having smaller radii of curvature. The smaller radius of curvature 310 increases the curvature of the opening 302, which may increase the tensile strength of the elongated body 104 as compared to an elongated body comprising an opening having a smaller radius of curvature. In some examples, the opening 302 may define a varying radius of curvature 310 along the elongate body 104, e.g., from a distal end to a proximal end of the distal section 110A. The variation may be linear or non-linear. In some examples, the radius of curvature 310 may decrease from the distal end to the proximal end of the distal section 110A, e.g., to increase tensile strength along the length of the distal section 110A, while maintaining torque responsiveness of the elongate body 104.

Mirror row openings 302 may include openings 302 having the same dimensions (e.g., the same length 306, axial span 307, beam length 408, spacing 410, radius of curvature 310, and/or depth). For example, as shown in fig. 3, each row of openings 302A may have an opening 302A with the same length 306 and axial span 307 as the openings 302B in the longitudinally adjacent row of openings 302B. The longitudinally adjacent rows of openings 302 and/or longitudinally adjacent regions 204 may define different sizes.

Fig. 5 illustrates an example proximal section 110B of the elongate body 104. The proximal section 110B includes a plurality of openings 402A, 402B (collectively "openings 402"). The opening 402 may be similar to the opening 302 of fig. 4 having a different size. In some examples, each of the openings 402B is a mirror image of one of the openings 402A. Openings 402A may be arranged in circumferential rows of openings 402A, and openings 402B may be arranged in circumferential rows of openings 402B. Each row of openings 402B may be offset from a longitudinally adjacent row of openings 402A by an angle in the circumferential direction. For example, the openings 402B may be offset in the circumferential direction from longitudinally adjacent openings 402A by an angle. The angle may be up to 90 degrees, for example, the angle may be 45 degrees. As shown in fig. 5, the openings 402A, 402B (collectively, "openings 402") may define dimensions (e.g., length, width, depth, beam length, pitch, angle of angular offset, angle of circumferential offset, radius of curvature) having different values than the openings 302 of fig. 4.

The proximal section 110B may include one or more of the regions 204 (e.g., region 204N), each region 204 including one or more rows of openings 402A and/or one or more rows of openings 402B. The rows of openings 402A and 402B may define a pattern 411. For example, each of the patterns 411 may include a single row of openings 402A and a single row of openings 402B. In other examples, pattern 411 may include two or more rows of openings 402A and/or two or more rows of openings 402B. The pattern 411 may be the same pattern as the pattern 311 of fig. 4 or a different pattern. The plurality of patterns 411 may define a spiral or helix extending along the proximal section 110B. The spiral or helix formed by pattern 411 may be part of the spiral or helix formed by pattern 311 or may be a separate spiral or helix.

Each of the openings 402 may define a length, an axial span 407, and a depth. The length, axial span 407, and depth of opening 402 may be similar to the length 306, axial span 307, and depth of opening 302, but with different values. For example, the length and axial span 407 may be measured in the same manner as the length 306 and axial span 307, respectively. The length and axial span 407 may vary along the proximal section 110B. For example, the length may increase from the distal end of the proximal section 110B to the proximal end of the proximal section 110B (e.g., proximal end 104B), and the axial span 407 may increase from the distal end of the proximal section 110B to the proximal end of the proximal section 110B. The length of each of the openings 402 may include an arc length 406 and a chord length 409, e.g., as discussed above.

Circumferentially adjacent openings 402 may be separated by a beam length 408. The beam length 408 represents the circumferential length of the uncut portion of the elongate body 108 between the openings 402 and may be measured from a first end of one opening 402 to a second end of a circumferentially adjacent opening 402. The portion of the elongate body 104 having the opening 402 defining the greater beam length 408 may exhibit increased tensile resistance and torque responsiveness relative to another portion of the elongate body 104 having the lower beam length 408.

The beam length 408 may vary along the length of the proximal section 110B of the elongate body 104. In some examples, the beam length 408 may increase from the distal end of the proximal section 110B to the proximal end of the proximal section 110B. In some examples, longitudinally adjacent or alternating rows of openings 402 may define different beam lengths 408. In some examples, a row of openings 402 within the same region 204 may define the same beam length 408, and different regions 204 may define different beam lengths 408.

The spacing 410 may be a longitudinal distance between longitudinally alternating rows of openings 402. The spacing 410 may be measured between the same points on the openings 402 in alternating rows of openings 402 (e.g., between the centers of two openings 402, between the first ends of two openings 402, between the second ends of two openings 402). The spacing 402 may vary along the proximal section 110B of the elongate body 104. For example, the spacing 402 may increase from the distal end of the proximal section 110B to the proximal end of the proximal section 110B. An increase in the spacing 402 along the proximal section 110B may increase the bending stiffness of the elongate body 104 along the proximal section 110B. In some examples, the spacing 402 may vary linearly or non-linearly along the proximal section 110B.

Longitudinally adjacent patterns 411 may be offset by an angle 404. Two corresponding openings 402 of two longitudinally adjacent patterns 411 (e.g., two corresponding openings 402A as shown in fig. 5) may define an angular offset angle 404. For example, the circumferential offset between the centers, first ends, and/or second ends of two corresponding openings 402 may define an angular offset angle 404. The angular offset angle 304 may vary (e.g., linearly or non-linearly) along the length of the elongated body 104. For example, the angular offset angle 304 may decrease from the distal end of the proximal section 110B to the proximal end of the proximal section 110B. In some examples, the angular offset angle 404 may be about 4 degrees to about 7 degrees. The angular offset angle 404 may control the circumferential offset angle of longitudinally adjacent rows of openings 402 within each pattern 411, e.g., as previously described herein.

Each of the openings 402 may define a radius of curvature 412. The radius of curvature 412 may be greater than the radius of curvature 310, for example, to increase the tensile strength of the proximal section 110B of the elongate body 104. Radius of curvature 412 may vary along proximal section 110B. In some examples, the radius of curvature 412 increases from the distal end of the proximal section 110B to the proximal end of the proximal section 110B.

In some examples, as shown in fig. 4 and 5, the elongate body 104 is divided into a distal section 110A and a proximal section 110B, each section having an opening 108 defining different parameters (e.g., different lengths, widths, spacing, radius of curvature, beam length, angle of angular offset, angle of circumferential offset, etc.). In other examples, the elongate body 104 is divided into three or more sections (e.g., 10 sections, 13 sections, 20 sections) along the longitudinal axis 106. Each section of the elongate body 104 may include an opening 108 defining a parameter value that is different from one or more other sections of the elongate body 104. The section of the elongate body 104 may be formed from a single continuous elongate member.

The openings 108 (e.g., openings 302, 402) within the section (e.g., from the distal end 104A to the proximal end 104B) across the section of the elongate body 104 may define a length having an arc length (e.g., arc lengths 309, 409) of about 0.300mm to about 0.500mm (e.g., about 0.0118in to about 0.0197 in) and a chord length (e.g., chord lengths 306, 406) of about 0.300mm to about 0.5mm (e.g., about 0.0118in to about 0.0197 in). The opening 108 may define a beam length (e.g., beam lengths 312, 408) of about 0.0600mm to about 0.200mm (e.g., about 0.0023in to about 0.0079 in). The openings 108 may define a pitch (e.g., pitches 308, 410) of about 0.12mm to about 2.54mm (e.g., about 0.0048in to about 0.0100 in). The opening 108 may define an angular offset angle (e.g., angular offset angles 304, 404) of about 4 degrees to about 14 degrees. The opening 108 may define a radius of curvature (e.g., radii of curvature 310, 412) of about 0.50mm to about 3.30mm (e.g., about 0.0196in to about 0.130 in).

Fig. 6A is a graph 600 illustrating an example bending stiffness of the example guidewire 100 of fig. 1. Graph 600 illustrates bending forces 604 experienced by the guidewire 100 and a comparable guidewire 602 in response to displacement 606 of the guidewire 100. The elongate body of the guidewire 602 can define a linear opening extending along a plane orthogonal to the longitudinal axis of the elongate body. The elongate body of the guidewire 602 can define varying parameters of the openings (e.g., spacing between the openings, beam length between the openings, circumferential offset angle) along the length of the elongate body.

The greater amount of bending force 604 experienced by the guidewire in response to a particular amount of displacement 606 corresponds to the increased bending stiffness of the guidewire. The displacement 606 defines an amount of bending away from a longitudinal axis of the guidewire 100, 602 (e.g., the longitudinal axis 106 of the guidewire 100). For each of the guidewires 100, 602, a greater displacement 506 represents a greater bending of the guidewire 100, 602 away from the longitudinal axis of each respective guidewire. The guidewire 602 can include an elongate body having the same or similar dimensions (e.g., length, thickness, outer diameter of the elongate body) as the elongate body 104 of the guidewire 100.

As shown in fig. 6A, the guidewire 606 may experience a similar force 504 in response to the same level of displacement 606 as the guidewire 100. In some examples, the guidewire 100 experiences a relatively increased or relatively decreased force 604 in response to the same level of displacement 606. The level of force experienced by the guidewire 100 in response to a particular amount of displacement 606 may depend on the radius of curvature of the openings 108 of the elongate body 104 of the guidewire 100 and/or the density of the openings 108 along a portion of the elongate body 104 (e.g., the spacing between the openings 108 and/or the beam length). For example, the increased density of openings 108 reduces the amount of force experienced by the guidewire 100 for a given amount of displacement 606, thereby reducing the bending stiffness of the guidewire 100. In some examples, the varying parameters of the openings 108 described herein may result in a significant increase in the tensile stiffness of the guidewire 100 in exchange for a marginal increase in the bending stiffness of the guidewire 100.

Fig. 6B is a graph 610 illustrating an example tensile stiffness of the example guidewire 100 of fig. 1. In graph 610, a greater force 612 along the longitudinal length of the guidewire corresponds to a greater tensile stiffness for the same amount of longitudinal displacement 614. As shown in graph 610, the guidewire 100 may exhibit a greater tensile stiffness than a comparable guidewire 602, e.g., such that for the same amount of longitudinal displacement 614, the guidewire 100 transmits a greater amount of force 612 along the longitudinal length of the guidewire 100 than the guidewire 602. For example, due to the increased transmission of force along the longitudinal length of the guidewire 100, the increased tensile stiffness may make the distal section 103A of the guidewire 100 more responsive to the force applied by the clinician to the proximal section 103B of the guidewire 100 than the guidewire 602. The varying parameters of the openings 108 of the guidewire 100 (e.g., radius of curvature, spacing, beam length, mirror image, angle of angular offset, length or width of the openings 108) may increase the tensile stiffness of the guidewire 100 without significantly increasing the bending stiffness, for example, as shown in graph 600. For example, the distal portion 110A of the elongate body 104 of the guidewire 100 can include openings having an increased radius of curvature and reduced spacing as compared to the proximal portion 110B of the elongate body 104, and can increase the tensile stiffness while maintaining the bending stiffness.

Fig. 6C is a graph 620 illustrating an example torque responsiveness of the example guidewire 100 of fig. 1. Graph 620 illustrates the transfer of force 622 in a circumferential direction (e.g., about the longitudinal axis of the guidewire) in response to circumferential displacement 624 of the guidewire about the longitudinal axis of the guidewire. For example, graph 620 illustrates an amount of force 622 transmitted in a circumferential direction along the length of each of the guidewires 100, 602 in response to a clinician rotating a proximal section (e.g., proximal section 103B) of each guidewire by a particular amount of displacement 624. As shown in graph 620, a guidewire 100 having an opening 108 (e.g., as previously described herein) may cause the guidewire 100 to exhibit the same level of torque responsiveness as a comparable guidewire 602 and an increase in the tensile stiffness of the guidewire 100 (e.g., as shown in graph 610). For example, the increased radius of curvature and reduced spacing of portions of the elongate body 104 can maintain the same or similar torque responsiveness of the guidewire 100 as the guidewire 602 while increasing the tensile stiffness of the guidewire 100 relative to the guidewire 602.

Fig. 7 is a flow chart illustrating an example method of manufacturing the elongated body 104 of fig. 1. Although the example method shown in fig. 7 is described herein primarily with respect to an example elongate body 104 having openings 108 similar to openings 302 and 402 as described in fig. 3-5, the example method may be applied to elongate bodies 104 having any other openings, cutouts, or voids as described herein.

The manufacturing system may determine placement (702) of a first plurality of rows of openings (e.g., openings 108, 302, 402) along the outer surface 202 of the elongated body 104. The plurality of first row openings 108 may be collectively referred to herein as a "first set of openings 108". The openings 108 in the first row of openings 108 may be oriented in the same direction. For example, each opening 108 in the first row of openings 108 may define a concave portion directed toward one of the distal end 104A or the proximal end 104B of the elongate body 104. The manufacturing system may determine the size of each of the openings 108 and/or the size between the openings 108 and/or retrieve a predetermined or preset size of the openings 108 and/or the size between the openings 108 and mark the placement of the openings 108 on the outer surface 202 of the elongated body 104 based on the retrieved size.

The dimensions of each opening 108 may include a length (e.g., chord 223, 306, 406, arc 224, 309, 409), a width (e.g., axial span 221, 307, 407), a radius of curvature (e.g., radius of curvature 207, 310, 412), and/or a depth (e.g., a thickness perpendicular to the plane of wall 107) of the opening 108. The dimensions between the openings 108 may include a beam length (e.g., beam lengths 228, 312, 408) between circumferentially adjacent openings 108, a spacing (e.g., spacing 226, 308, 410) between longitudinally alternating first rows of openings 108, an angular offset angle (e.g., angular offset angles 230, 304, 404) between longitudinally adjacent patterns (e.g., patterns 235, 311, 411) of openings 108, and/or a circumferential offset angle (e.g., circumferential offset angle 232). The size of the openings 108 and/or the size between the openings 108 may vary along the elongate body 104. For example, one or more of the dimensions (e.g., beam length, spacing) may increase from the distal end 104A to the proximal end 104B, and one or more of the dimensions (e.g., length, radius of curvature, angle of angular offset) may decrease from the distal end 104A to the proximal end 104B.

Based on the determined dimensions, the manufacturing system may determine the placement of the other openings 108 forming the first row of openings 108 based on the placement of one or more openings 108. The manufacturing system may determine placement of the first openings 108 on the distal section 110A of the elongate body 104 and determine placement of the remaining openings 108 defining the first row of openings 108 based on the determined size and position relative to the first openings 108.

The manufacturing system may determine placement of the plurality of second row openings 108 along the outer surface of the elongated body 104 (704). The plurality of second row openings 108 may be collectively referred to herein as a "second set of openings 108". Each second row of openings 108 may be a mirror image of the first row of openings 108. For example, with respect to the example distal section 110A shown in fig. 3, the first row of openings 108 may include openings 302A and the second row of openings 108 may include openings 302B. In some examples, the openings 108 in the first and second rows of openings 108, 108 may define concave portions directed toward the ends of the elongated body 104 and in opposite directions.

Each second row of openings 108 may be longitudinally adjacent to two first rows of openings 108. In some examples, as shown in fig. 1-4, each second row of openings 108 may be disposed between two first rows of openings 108, thereby longitudinally alternating the first rows of openings 108. The openings 108 in each second row of openings 108 may be circumferentially offset from the openings in the longitudinally adjacent first row of openings 108, e.g., as previously discussed herein. The manufacturer may determine the placement of the second row based on the size of the second row and/or the relationship between the first row and the second row.

The first row of openings 108 and the second row of openings 108 may form a repeating pattern (e.g., patterns 235, 311, and 411) on the elongated body 104. In some examples, a manufacturer may determine a plurality of regions 204 on the elongate body 104 and place two or more rows of openings 108 (first and/or second rows) in each region 204. In some examples, the openings 108 within each region 204 may have the same size and/or may be the same type of openings 108 (e.g., openings 302A, 302B, 402A, 402B). In some examples, each of the regions 204 may include two or more types of openings 108. For example, one region (e.g., region 204A) may include openings 302A and 302B, and another region 204 (e.g., region 204N) may include openings 402A and 402B. One or more of the regions 204 may be a mirror image of another of the regions 204. For example, the region 204B may be a mirror image of the region 204A relative to a reference plane perpendicular to the longitudinal axis 106 of the elongate body 104.

The manufacturing system may form a plurality of first row openings 108 and a plurality of second row openings (706) on an outer surface of the elongated body 104. In some examples, the manufacturing system may first form the elongated body 104 and form the openings in the first and second rows of openings 108, 108 on the elongated body 104 using any suitable technique. For example, the manufacturing system may form the openings 108 via etching, laser cutting, or mechanical cutting into the tubular body or other material forming the wall 107 of the elongated body 104 via a blade, slot plane, abrasive disk, or the like. In some examples, the manufacturing system may use additive manufacturing techniques (e.g., three-dimensional (3D) printing techniques) to form the elongated body 104 and define the opening 108 during additive manufacturing.

Fig. 8 is a flow chart illustrating another example method of manufacturing the elongated body 104 of fig. 1. Although fig. 8 primarily depicts the formation of openings 108 having varying radii of curvature on the elongated body 104, the example method shown in fig. 8 may be applied to the formation of openings 108 having the same radii of curvature or having other varying dimensions on the elongated body 104.

The manufacturing system may determine placement of the plurality of openings 108 along an outer surface of the elongate body 104 (802). The manufacturing system may determine the placement of each of the openings 108, e.g., as previously described herein. Each of the openings 108 may define an arc defining a concave portion. The concave portion may extend toward the distal end 104A or the proximal end 104B of the elongate body 104. Each of the openings 108 may define a different size than the longitudinally distal and/or longitudinally proximal openings 108. In some examples, the size of the openings 108 and/or the size between the openings 108 (e.g., as previously described herein) may vary (e.g., increase or decrease) along the elongate body 104 from the distal end 104A to the proximal end 104B. In some examples, the manufacturing system may arrange the openings 108 in circumferential rows of openings 108. In such examples, longitudinally adjacent rows of openings 108 may define concave portions extending toward different ends of the elongated body 104.

The manufacturing system may define a plurality of regions 204 on the outer surface of the elongated body 104 and place the row of openings 108 in each of the regions 204. The regions 204 may have the same longitudinal length along the longitudinal axis 106, or may have different longitudinal lengths. Each region 204 may have the same number of rows of openings 108 and/or the same number of openings 108 as another region 204. In some examples, the region 204 may have a different number of rows of openings 108 and/or a different number of openings 108. In some examples, the openings 204 within each region 204 may have the same size and/or may define the same size between the openings 108. In some examples, the openings 108 within one region 204 (e.g., region 204A) may have different sizes or define different sizes between the openings 108 than the openings 108 of another region 204 (e.g., region 204B).

The manufacturing system may define a radius of curvature (e.g., radius of curvature 310, radius of curvature 412) for each opening 108 of the plurality of openings 108 (804). The manufacturing system may define the radius of curvature of the opening 108 to vary along the length of the elongated body 104. For example, the manufacturing system may define the radius of curvature of the opening 108 to increase from the distal end 104A to the proximal end 104B, e.g., to decrease the radius of curvature of the distal section 110A of the elongate body 104. The change may be linear, non-linear, or discrete (e.g., a gradual change in radius of curvature). In some examples, the radius of curvature of the openings 108 defining the row may be the same for each row of openings 108. In some examples, each of the regions 204 may include an opening 108 defining a different radius of curvature. In such examples, each region 204 may define an opening 108 defining a radius of curvature greater than the longitudinal proximal region 204. For each opening 108, the manufacturer may select a radius of curvature based on a desired bending stiffness and/or radius of curvature along a particular location of the elongate body 104 including the opening 108. The manufacturer may then form a plurality of openings 108 (806) on the outer surface of the elongate body 104, e.g., as previously described herein.

The examples described herein may be combined in any permutation or combination. The disclosure herein describes all of the following embodiments.

Embodiment 1 a guidewire comprising a core wire defining a longitudinal axis, and an elongate body extending along the longitudinal axis, the elongate body defining a lumen configured to hold a distal portion of the core wire, and a plurality of openings, wherein each opening of the plurality of openings defines an arc defining a radius of curvature and a concave portion facing either a distal end of the elongate body or a proximal end of the elongate body, and wherein the radius of curvature of the plurality of openings varies along the longitudinal axis.

Embodiment 2 the guidewire of embodiment 1, wherein the radius of curvature of the plurality of openings decreases from the distal end of the elongate body to the proximal end of the elongate body.

Embodiment 3 the guidewire of any one of embodiments 1 and 2, wherein the radius of curvature of the plurality of openings increases from a proximal portion of the elongate body to the distal end of the elongate body.

Embodiment 4 the guidewire of any one of embodiments 1-3, wherein the plurality of openings comprises a first set of openings disposed at a first location on the elongate body and a second set of openings disposed at a second location on the elongate body, the first set of openings defining a first radius of curvature and the second set of openings defining a second radius of curvature, wherein the second location is closer to the first location, and wherein the first radius of curvature is greater than the second radius of curvature such that the elongate body is more resistant to tension at the first location than at the second location.

Embodiment 5 the guidewire of any one of embodiments 1-4, wherein the plurality of openings comprises a first set of openings disposed at a first location on the elongate body and a second set of openings disposed at a second location on the elongate body, the first set of openings defining a first radius of curvature and the second set of openings defining a second radius of curvature, wherein the second location is further from the first location, and wherein the first radius of curvature is greater than the second radius of curvature such that the elongate body is more resistant to tension at the first location than at the second location.

Embodiment 6 the guidewire of any one of embodiments 1-5, wherein the elongate body defines a first region and a second region along the longitudinal axis, the second region longitudinally adjacent to the first region, wherein the first region comprises a first set of openings of the plurality of openings, and the second region comprises a second set of openings of the plurality of openings, wherein the openings of the first set define a different radius of curvature than the openings of the second set.

Embodiment 7 the guidewire of any one of embodiments 1-6, wherein the plurality of openings comprises a first set of openings and a second set of openings, wherein each opening of the first set of openings is longitudinally adjacent to and a mirror image of a corresponding opening of the second set of openings along a plane perpendicular to the longitudinal axis.

Embodiment 8 the guidewire of any one of embodiments 1-7, wherein the plurality of openings comprises a plurality of circumferential row openings, wherein each circumferential row opening is separated from an adjacent circumferential row opening in the direction of the longitudinal axis, wherein for each circumferential row opening, circumferentially adjacent openings are separated by a beam length, and wherein the beam length increases as the radius of curvature of an opening in the corresponding circumferential row opening decreases along the length of the elongate body.

Embodiment 9 the guidewire of embodiment 8, wherein the beam length decreases in a distal direction along the length of the elongate body.

Embodiment 10 the guidewire of embodiment 8, wherein the beam length increases in a distal direction along the length of the elongate body.

Embodiment 11 the guidewire of any one of embodiments 1-10, wherein the plurality of openings comprises a plurality of circumferential rows of openings, wherein longitudinally adjacent circumferential rows of openings are separated by a longitudinal distance, wherein the longitudinal distance varies along the length of the elongate body, wherein the longitudinal distance varies in a direction opposite the variation in the radius of curvature, and wherein the variation in the longitudinal distance and the variation in the radius of curvature increase flexibility of the distal portion of the elongate body relative to the proximal portion of the elongate body.

Embodiment 12 the guidewire of embodiment 11, wherein the longitudinal distance decreases in the distal direction.

Embodiment 13 the guidewire of embodiment 11, wherein the longitudinal distance increases in the distal direction.

Embodiment 14 the guidewire of any one of embodiments 1-13, wherein the elongate body comprises a hypotube.

Embodiment 15 the guidewire of any one of embodiments 1-14, wherein each arc defines an angle of less than or equal to 180 degrees.

Embodiment 16 the guidewire of any one of embodiments 1-15, wherein the radius of curvature is from 0.5 millimeters (mm) to 3mm.

Embodiment 17 the guidewire of any one of embodiments 1-16, wherein the change in the radius of curvature of the plurality of openings increases a tensile strength of a distal portion of the elongate body relative to a proximal portion of the elongate body.

Embodiment 18 the guidewire of any one of embodiments 1-17, wherein the arc defined by the plurality of openings enables the elongate body to bend in any plane about the longitudinal axis.

Embodiment 19 a method of manufacturing the guidewire of any one of embodiments 1-18, the method comprising determining placement of the plurality of openings along an outer surface of the elongate body, determining the radius of curvature of each of the plurality of openings, and forming the plurality of openings into the outer surface of the elongate body, each opening defining a corresponding determined radius of curvature.

Embodiment 20 a guidewire comprising a core wire, and an elongate body extending along a longitudinal axis, the elongate body defining a lumen, wherein a distal portion of the core wire is positioned within the lumen, and a plurality of openings disposed along the elongate body between a distal end of the elongate body and a proximal end of the elongate body, wherein each of the plurality of openings defines an arc defining a radius of curvature and extending from a first end to a second end, wherein the first end and the second end are disposed at a same longitudinal position along the elongate body, and wherein for each arc a center of the arc is disposed at a different longitudinal position than the first end and the second end of the arc, wherein the plurality of openings define a plurality of rows of openings around a circumference of the elongate body, wherein the longitudinal distances between longitudinally adjacent rows of openings and the radius of curvature of the plurality of openings increase or decrease between the distal end and the proximal end.

Embodiment 21 the guidewire of embodiment 20, wherein the radius of curvature of the plurality of openings increases or decreases non-linearly from the distal end to the proximal end.

Embodiment 22 the guidewire of any one of embodiments 20 and 21, wherein the radius of curvature of the plurality of openings increases or decreases linearly from the distal end to the proximal end.

Embodiment 23 the guidewire of any one of embodiments 20-22, wherein the longitudinal distance decreases in a distal direction along the longitudinal axis, and wherein the radius of curvature of the plurality of openings increases in the distal direction along the longitudinal axis.

Embodiment 24 the guidewire of any one of embodiments 20-23, wherein the longitudinal distance increases in a distal direction along the longitudinal axis and the radius of curvature of the plurality of openings decreases in a distal direction along the longitudinal axis.

Embodiment 25 the guidewire of any one of embodiments 20-24, wherein the elongate body defines a first longitudinal region and a second longitudinal region, wherein the first longitudinal region comprises a first plurality of rows of openings and the second longitudinal region comprises a second plurality of rows of openings, and wherein the first plurality of rows of openings are separated by a first longitudinal distance, wherein the second plurality of rows of openings are separated by a second longitudinal distance, and wherein the first longitudinal distance is greater than the second longitudinal distance.

Embodiment 26 the guidewire of embodiment 25, wherein each first row of openings defines a first radius of curvature, wherein each second row of openings defines a second radius of curvature, and wherein the first radius of curvature is less than the second radius of curvature.

Embodiment 27 the guidewire of any one of embodiments 20-26, wherein for each row of openings in the plurality of openings, circumferentially adjacent openings are separated by a beam length, and wherein the beam length increases or decreases between the distal end and the proximal end.

Embodiment 28 the guidewire of any one of embodiments 20-27, wherein the plurality of openings comprises a first set of openings and a second set of openings, wherein each opening of the first set of openings is longitudinally adjacent to and a mirror image of a corresponding opening of the second set of openings along a plane perpendicular to the longitudinal axis.

Various aspects of the disclosure have been described. These and other aspects are within the scope of the following claims.

Claims

1. A guidewire, the guidewire comprising:

Core wire, the core wire defining a longitudinal axis; and

An elongated body extending along the longitudinal axis, the elongated body defining:

An inner cavity, the inner cavity being configured to hold the distal portion of the core wire; and

A plurality of openings, wherein each of the plurality of openings defines an arc, the arc defining a radius of curvature and a concave portion facing a distal end or a proximal end of the elongated body, and wherein the radius of curvature of the plurality of openings varies along the longitudinal axis.

2. The guidewire of claim 1, wherein the radius of curvature of the plurality of openings decreases from the distal end of the elongated body to the proximal end of the elongated body.

3. The guidewire according to any one of claims 1 or 2,

The plurality of openings includes a first set of openings at a first location on the elongated body and a second set of openings at a second location on the elongated body, the first set of openings defining a first radius of curvature and the second set of openings defining a second radius of curvature.

The second position is closer to the first position, and

The first radius of curvature is greater than the second radius of curvature, which makes the slender body more resistant to tension at the first position than at the second position.

4. The guidewire according to any one of claims 1 to 3,

The second position is farther away from the first position, and

5. The guidewire according to any one of claims 1 to 4, wherein the elongated body defines a first region and a second region along the longitudinal axis, the second region being longitudinally adjacent to the first region, wherein the first region includes a first set of openings among the plurality of openings, and the second region includes a second set of openings among the plurality of openings, wherein the openings in the first set define a different radius of curvature than the openings in the second set.

6. The guidewire according to any one of claims 1 to 5, wherein the plurality of openings comprises a first group of openings and a second group of openings, wherein each opening in the first group of openings is longitudinally adjacent to a corresponding opening in the second group of openings along a plane perpendicular to the longitudinal axis and is a mirror image of the corresponding opening in the second group of openings.

7. The guidewire according to any one of claims 1 to 6, wherein the plurality of openings comprises a plurality of circumferential row openings, wherein each circumferential row opening is separated from an adjacent circumferential row opening in the direction of the longitudinal axis, wherein for each circumferential row opening, circumferentially adjacent openings are separated by a beam length, and wherein the beam length increases as the radius of curvature of the opening in the corresponding circumferential row opening decreases along the length of the elongated body.

8. The guidewire according to any one of claims 1 to 7, wherein the plurality of openings comprises a plurality of circumferential rows of openings, wherein longitudinally adjacent circumferential rows of openings are separated by a longitudinal distance, wherein the longitudinal distance varies along the length of the elongated body, wherein the longitudinal distance varies in a direction opposite to the change in the radius of curvature, and wherein the change in the longitudinal distance and the change in the radius of curvature increase the flexibility of the distal portion of the elongated body relative to the proximal portion of the elongated body.

9. The guidewire according to any one of claims 1 to 8, wherein the elongated body comprises a hyaluronic acid tube.

10. The guidewire according to any one of claims 1 to 9, wherein the change in the radius of curvature of the plurality of openings increases the tensile strength of the distal portion of the elongated body relative to the proximal portion of the elongated body.

11. The guidewire according to any one of claims 1 to 10, wherein the arc defined by the plurality of openings allows the elongated body to bend about the longitudinal axis in any plane.

12. The guidewire according to any one of claims 1 to 11,

The first group of openings defines a plurality of first circumferential row openings, and the second group of openings defines a plurality of second circumferential row openings.

Each of the first circumferential row openings is separated from the second circumferential row opening adjacent to the first longitudinal row by a first longitudinal distance, and

Each of the first circumferential row openings is separated from the second longitudinally adjacent second circumferential row opening by a second longitudinal distance, wherein the second longitudinally adjacent second circumferential row opening is different from the first longitudinally adjacent second circumferential row opening, and wherein the second longitudinal distance is different from the first longitudinal distance.

13. A guidewire, the guidewire comprising:

Core wire; and

An elongated body extending along a longitudinal axis, the elongated body defining:

The inner cavity, wherein the distal portion of the core wire is positioned within the inner cavity; and

A plurality of openings are disposed along the elongated body between a distal end and a proximal end of the elongated body, wherein each of the plurality of openings defines an arc, the arc defining a radius of curvature and extending from a first end to a second end, wherein the first end and the second end are disposed at the same longitudinal position along the elongated body, and wherein for each arc, the center of the arc is disposed at a different longitudinal position from the first end and the second end of the arc.

The plurality of openings define multiple rows of openings around the periphery of the elongated body, wherein longitudinally adjacent rows of openings are separated by a longitudinal distance, and wherein the longitudinal distance between longitudinally adjacent rows and the radius of curvature of the plurality of openings increase or decrease between the distal end and the proximal end.

14. The guidewire according to claim 13,

The elongated body defines a first longitudinal region and a second longitudinal region, wherein the first longitudinal region includes a plurality of first row openings and the second longitudinal region includes a plurality of second row openings.

The plurality of first row openings are separated by a first longitudinal distance, the plurality of second row openings are separated by a second longitudinal distance, and the first longitudinal distance is greater than the second longitudinal distance.

15. The guidewire according to any one of claims 13 or 14,