Guiding elements for intravascular access devices

Abstract

A guide element for an intravascular access device can include an intravascular access device having a needle within a catheter lumen and a working space between an outer surface of the needle and an inner surface of the catheter, the working space configured to receive one or more tools therethrough, and a guide element having distal and proximal ends separated by one or more annular elements, the guide element configured to be advanced distally from the intravascular access device within a blood vessel, the one or more annular elements configured to control at least the distal end of the guide element.

Description

[Technical Field]

[0001] [Priority Claim]

[0001] This patent application claims priority to U.S. Provisional Patent Application No. 63 / 408,419, entitled "GUIDE ELEMENT FOR INTRAVASCULAR ACCESS DEVICE," filed September 20, 2022, the entirety of which is incorporated by reference.

[0002] [Incorporated by reference]

[0002] All publications and patent applications mentioned in this specification are incorporated herein by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. [Background technology]

[0003]

[0003] Intravenous access, such as venipuncture, is a necessary component of several medical procedures. Venipuncture generally refers to the process of obtaining intravenous access for any one of a variety of purposes, including intravenous infusion, medical treatment, blood sampling, etc. In hospitals, for example, venipuncture is commonly used to place thin intravenous catheters for intravenous fluid delivery, medication delivery, blood sampling, etc.

[0004] While venipuncture and other forms of vascular access can be straightforward in relatively healthy patients, such access is often required in less healthy patients, who may have arteries and / or veins that are thin, tortuous, collapsed, fragile, and / or difficult to locate. In these patients, venipuncture and other forms of vascular access can be particularly challenging for inexperienced phlebotomists, emergency medical technicians, nurses, and other healthcare professionals.

[0005] In addition to difficult access, many vascular catheter placement systems can result in accidental puncture and / or accidental needle contamination during or after placement of the intravascular catheter. Furthermore, some conventional catheter placement devices employ relatively complicated deployment handle movements that increase both cost and complexity. Additionally, conventional handle placement and movements can obscure the presence and status of the tool's needle and guide structure or element components, thus making use of the insertion tool less intuitive. Summary of the Invention [Problem to be solved by the invention]

[0006] For these reasons, it would be desirable to provide improved methods, systems, and tools for deploying intravascular catheters using needles and guiding structures. It would be particularly desirable to provide simplified deployment systems and assemblies having fewer components, and even more desirable to provide components that are clearly visible to the user and configured to be utilized and operated in a straightforward, intuitive manner. At least some of these objectives will be achieved by the various embodiments that follow. [Means for solving the problem]

[0007]

[0007] Described herein are guide elements, intravascular access devices, and methods of using them.

[0008] In general, a guide element for an intravascular access device comprises an intravascular access device having a catheter body having a distal end, a proximal end, and a lumen extending therethrough, a needle within the catheter lumen, and a working space between the outer surface of the needle and the inner surface of the catheter, the working space may be configured to receive one or more tools therethrough, and a guide element within the working space, wherein a portion of the catheter body adjacent the guide element is displaced in response to distal movement of the guide element along the needle within the working space.

[0008]

[0009] This and other examples described herein also include any of the following: a portion of the catheter body can be displaced by moving a flap formed on the catheter body in response to a guide element; a portion of the catheter body can be displaced by a guide element having a different durometer than the remainder of the catheter body; a portion of the catheter body having a different durometer that can be displaced by movement of the guide element can be an annular portion at the distal-most portion of the catheter body; a portion of the catheter body having a different durometer that can be displaced by movement of the guide element can be adjacent to the working space or within a semicircular portion corresponding to the flat portion of the needle; the catheter body can have a first portion formed from a material of a first durometer and a second portion formed from a material of a second durometer, where the first portion can be adjacent to the working space and the first durometer can be selected such that the first portion deflects or deforms in use in response to the distal end of the guide element being advanced against the first portion.

[0009]

[0010] In general, a guide element for use with an intravascular access device may comprise an intravascular access device having a needle within a catheter lumen and a working space between an outer surface of the needle and an inner surface of the catheter, the working space may be configured to receive one or more tools therethrough, the guide element may have distal and proximal ends separated by one or more annular elements, the guide element may be configured to be advanced distally from the intravascular access device within a blood vessel, and the one or more annular elements may be configured to control at least the distal end of the guide element.

[0010]

[0011] In some examples, the intravascular guide element may further have at least two annular elements, and the first annular element may be configured to control the direction of movement of the guide element distal end. The distal end of the guide element may be an atraumatic tip. The distal end of the guide element may be a shaped distal tip. The guide element may be comprised of multiple segments. The intravascular guide element may further include at least four annular elements. The needle may have at least one flat surface, and the working space is defined by an inner arc of the catheter inner surface and the needle flat surface. The distal tip may further include one or more deployment slits aligned with the working space. The catheter distal tip may further include one or more conformal segments, and the distal tip of the guide element may be configured to engage with the one or more conformal segments.

[0011]

[0012] In general, the intravascular access device may include a handle having a proximal end and a distal end, and a slot extending from the proximal end to the distal end. The catheter may have a proximal catheter hub and a distal catheter lumen, the proximal catheter hub being releasably engageable with the distal end of the handle. The access needle may extend proximally from within the needle holder through the catheter lumen, the access needle having at least one flat surface extending longitudinally along the circumference of the access needle, and a tissue-piercing tip extending distally beyond the catheter lumen. Also included may be a working space within the catheter along the length of the at least one flat, convex, or concave access needle, configured to facilitate passage of one or more tools therethrough distally from the proximal end of the intravascular access device into the blood vessel. The slider can extend through the slot and can be in communication with the proximal end of the guide element such that distal advancement of the slider advances the distal tip portion of the guide element from its position within the guide element notch distally along at least one flat surface of the access needle.

[0012]

[0013] In some examples, at least one flat surface of the access needle extends longitudinally along the outer surface of the access needle. The at least one tool comprises a guide element. A working space may be defined by the needle flat surface and the inner surface of the catheter, the working space being selectively accessible from the proximal end of the intravascular access device. The working space may be configured to selectively open at the distal end of the catheter, the working space being configured to guide a tool or tool segment sliding therethrough. The intravascular access device may further include an access needle lumen, and the guide element may comprise multiple annular elements between the distal end and the proximal end, one or more of which may extend through the access needle lumen. The intravascular access device may further include a hemostatic valve having a longitudinal groove around the periphery of the homeostatic valve, and the hemostatic valve may be disposed in the proximal catheter hub. The access needle may comprise multiple flat surfaces, each of which may be associated with a separate working space within the catheter lumen.

[0013]

[0014] In some examples, the intravascular access device can further include an activation button coupled to the needle holder and an activation element that applies a force to the needle holder toward the proximal end of the handle, whereby when the activation button is depressed, the activation element displaces the needle holder and the access needle toward the proximal end of the handle. The access needle may be retracted proximally toward the handle, and the guide element may be configured to remain in a distally advanced position. The intravascular access device can further include a spool of guide element in communication with the proximal end of the intravascular device, where a length of the guide element can be housed within the spool. The guide element can be made entirely or partially of a metallic material, a polymeric material, or a combination thereof. The guide element can include multiple segments, where one or more of the multiple segments can comprise different materials.

[0014]

[0015] All of the methods and devices described herein are contemplated herein in any combination and may be used to achieve the benefits described herein.

[0016] A more complete understanding of the features and advantages of the methods and apparatus described herein will be obtained by reference to the following detailed description that sets forth illustrative embodiments and the accompanying drawings. [Brief explanation of the drawings]

[0015] [Figure 1]

[0017] 1A-1C are diagrams of examples of guidewire elements described herein for use with intravascular access devices. [Figure 2]

[0018] 1 illustrates a distal end of an atraumatic guidewire element for use with an intravascular access device, according to examples described herein. [Figure 3A]

[0019] 10A-10C are diagrams illustrating details of the configuration of a guidewire element associated with an intravascular access device, according to examples described herein. [Figure 3B] 10A-10C are diagrams illustrating details of the configuration of a guidewire element associated with an intravascular access device, according to examples described herein. [Figure 4]

[0020] 10A-10C illustrate an example deployment of a guide element advancing outward from an intravascular access device, according to examples described herein. [Figure 5]

[0021] 5A and 5B are diagrams of example details of the distal end of a guide element described herein. [Figure 6]

[0022] Figures 6A, 6B, and 6C are cross-sectional views of an intravascular access device and an example of a transition from a retracted configuration to a deployed configuration according to examples described herein. [Figure 7]

[0023] 7A and 7B are cutaway cross-sectional views of an intravascular access device showing the transition of a guide element from a retracted position to a deployed position according to examples described herein. [Figure 8]

[0024] 8A is a diagram illustrating an exemplary example of a guide element configuration along a length of a guide element including a distal end, according to examples described herein; FIG. 8B is a diagram illustrating an exemplary example of a guide element configuration along a length of a guide element including a distal end, according to examples described herein; FIG. 8C is a diagram illustrating an exemplary example of a guide element configuration along a length of a guide element including a distal end, according to examples described herein; FIG. 8D is a diagram illustrating an exemplary example of a guide element configuration along a length of a guide element including a distal end, according to examples described herein; FIG. 8E is a diagram illustrating an exemplary example of a guide element configuration along a length of a guide element including a distal end, according to examples described herein; and FIG. 8F is a diagram illustrating an exemplary example of a guide element configuration along a length of a guide element including a distal end, according to examples described herein. [Figure 9]

[0025] 9A, 9B, 9C, and 9D are diagrams of multifilament guide elements including different configurations according to examples described herein, respectively. [Figure 10]

[0026] 10A and 10B illustrate a distal end configuration of an intravascular access device according to examples described herein. [Figure 11]

[0027] 11A, 11B, and 11C are diagrams illustrating example distal end configurations of an intravascular access device according to examples described herein. [Figure 12]

[0028] 12A and 12B illustrate example distal end configurations of an intravascular access device, according to examples described herein. [Figure 13]

[0029] 13A and 13B are cross-sectional views illustrating example distal end configurations of intravascular access devices, according to examples described herein. [Figure 14]

[0030] 14A, 14B, and 14C are cross-sectional views illustrating example guide element elongate body configurations described herein. [Figure 15]

[0031] Figures 15A, 15B, and 15C show examples of distal catheter sections including details of guide element distal tips as described herein. [Figure 16]

[0032] 10A-10C illustrate examples of guide elements for use with an intravascular access device. DETAILED DESCRIPTION OF THE INVENTION

[0016]

[0033] The intravascular access device may include a needle disposed at least partially within the catheter. The needle may be configured to pierce and traverse one or more layers of tissue until access to the blood vessel is achieved. The catheter may optionally advance through one or more layers of tissue as the needle is advanced. Once inside the blood vessel, it may be desirable to advance the catheter over the needle and into the blood vessel. Generally, a guide element positioned between the outer surface of the needle and the inner surface of the catheter may be selectively manipulated (e.g., advanced) to direct the catheter distal tip forward to help guide and position the catheter within the blood vessel distal to the insertion point. The guide element may have one or more features that provide increased function, control, and safety.

[0017]

[0034] The intravascular access devices described herein can include a working space or channel created by a needle having a semicircular cross-sectional geometry. Current intravascular access devices provide a concentric circular cross-sectional geometry between the needle and the catheter (e.g., a tubular needle inside a tubular catheter). The intravascular access devices described herein provide a needle having a semicircular cross-sectional geometry, such as a needle having a circumference that includes an arc and a generally flat segment. In some examples, the arc portion of the needle circumference can be less than 360 degrees, less than 350 degrees, less than 340 degrees, less than 330 degrees, less than 320 degrees, less than 310 degrees, less than 300 degrees, less than 270 degrees, less than 180 degrees, or more. In some examples, the flat surface of the needle defines a discontinuous circular circumference (e.g., a circle with a segment removed). In some examples, the flat segment on the circumference of the needle can relate to a small segment missing from an otherwise complete circumference.

[0018]

[0035] The dimension of the workspace can be the area of ​​a small section of the needle missing. For example, if we consider a cross section of the needle and catheter at any point along their length, the area of ​​the workspace can be calculated as the difference between the area of ​​the needle and the circular cross section of the catheter. For example, at any cross section of the catheter, the area is πr 2 The area of ​​the needle can be calculated as πr, where r is the radius of the catheter circular cross section. 2 -It can be calculated as the area of ​​the small missing section. Therefore, the working space can be the difference between the area inside the catheter and the area of ​​the needle.

[0019]

[0036] The working space may be configured to accommodate one or more tools (e.g., a guide element). In some examples, the working space between the exterior of the needle and the inner surface of the catheter may be configured to accommodate a guide element, as described herein. In some examples, the working space may be configured to accommodate procedure-related tools. For example, tools may be selectively moved into and / or through the working space from the proximal end of the intravascular access device to the distal end or tip of the intravascular access device (e.g., the distal tip of a catheter).

[0020]

[0037] The working space may be configured to accommodate the administration of one or more therapies during an intravascular access procedure. For example, a distal tip of a needle may first penetrate the tissue and traverse the tissue until entering a blood vessel. A catheter of the intravascular access device may traverse the tissue with the needle until the distal tip of the catheter enters the interior of the blood vessel. An operator may then introduce a tool through the proximal end of the intravascular access device, accessible from outside the patient's body, and advance the tool through the intravascular access device so that the tool passes or slides within the working space between the outer surface of the needle and the inner surface of the catheter until the tool is operatively deployed within the blood vessel as achieved by positioning the distal tip of the catheter. The operator may engage the proximal end of the tool and / or the proximal end of the intravascular access device to control the tool within the blood vessel. After the procedure is completed, the operator may retract the tool through the working space, allowing the intravascular access device to remain in place within the blood vessel.

[0021]

[0038] According to any of the examples described herein, it may be beneficial to guide an intravascular access device into and / or through a patient's vasculature. For example, the intravascular access device may first penetrate and traverse the tissue until entering the blood vessel. The catheter of the intravascular access device may need to be advanced beyond initial placement into the blood vessel, aided by the needle distal tip. Thus, to aid in routing and positioning the catheter through distal areas of the vasculature, a guide element may be deployed prior to catheter deployment. The guide element may include distal and proximal ends separated by a length of a guide element body configured to pass through the intravascular access device, having a working space between the needle and the interior of the catheter, as described herein.

[0022]

[0039] FIG. 1 illustrates an example of an intravascular access device 100 described herein engaging a patient's blood vessel 101. An example guide element feature is shown in which the distal end of the guide element 105 is curled to form an atraumatic distal end. An advantage of the atraumatic tip or distal end of the guide element described herein is that it prevents unintentional vessel perforation by the guide element or other adverse events, such as snagging of the guide element distal end by the patient's vascular anatomy. Once the needle 115 is inserted into the blood vessel 101, the guide element distal end 105 can be advanced into the blood vessel and curled in accordance with the shape memory of the guide element material (e.g., Nitinol).

[0023]

[0040] In some examples, the guide elements described herein may have a distal end configured to engage the inside of a blood vessel. For example, the distal end may include a distal tip (e.g., a distal terminal end) and a section of the guide element body. As shown in FIG. 1 , the curled atraumatic distal end of the guide element may be configured to advance through the blood vessel and maintain a geometry when advanced through the blood vessel. In some examples, the distal end of the guide element can apply a force against the inside of the blood vessel to open a collapsed or partially collapsed blood vessel or otherwise facilitate passage of a catheter through the collapsed or partially collapsed blood vessel.

[0024]

[0041] FIG. 2 shows an example of a guide element 105 described herein. Similar to FIG. 1, the guide element distal end 110 is curled to form an atraumatic tip. In some examples, the guide element is generally straight at the distal end in a retracted or ready configuration and can automatically conform to the atraumatic distal end as the guide element 105 is advanced distally from the intravascular access device 100. In FIG. 2, the guide element is shown advanced from within a needle 115. The needle 115 may have an aperture extending therethrough from the needle distal tip 116 to the proximal end of the needle (not shown). The guide element may be configured to pass through or be advanced through the needle aperture to enter a patient's vasculature.

[0025]

[0042] The distal end of the guide element may be flexible in one or more sections, including the distal end and / or one or more sections of the guide element body. For example, Figure 2 shows the guide element being advanced beyond the needle distal tip and, after contacting the inner surface of the blood vessel, bending against the inner vessel surface and continuing into the blood vessel with the aid of the curved distal end.

[0026]

[0043] In some instances, the guide element may be initially positioned within the intravascular device so that it slides through the needle aperture and further distally past the needle tip into the blood vessel. In such a configuration, the needle may be retractable toward the proximal end of the intravascular access device, allowing the guide element to remain in place, or the guide element may be advanceable into the vasculature without the needle having to remain in place. Such a configuration can reduce the amount of invasive trauma to the blood vessel because the needle may be completely removed from the blood vessel and / or the patient's anatomy, yet the guide element remains effective to guide the catheter as it is advanced into the blood vessel along the guide element path.

[0027]

[0044] The guide element may initially be provided in one or more retracted or ready configurations throughout the intravascular access device. In some examples, the guide element may be generally linear from the distal end to the proximal end and configured to slide within the intravascular access device through the working space between the needle outer surface and the catheter inner surface. In some examples, the guide element may be configured to slide within the intravascular access device via the needle aperture. In some examples, as described herein, the guide element may be configured to advance distally from the distal end of the intravascular access device through the needle aperture while looping proximally through the working space of the intravascular access device. In some examples, the guide element may loop back to the same area or space from which it was advanced. For example, in FIG. 3A , a guide element distal loop 120 is shown, where the guide element 106 is advanced from within the needle aperture. A dotted line is included to illustrate an example of the distal end retracing back through the needle aperture toward the proximal end of the intravascular access device. In some examples, the guide element may be a single length of material or materials and may be advanced through the intravascular access device into a blood vessel, guided by a point between the distal and proximal ends of the guide element. In some examples, the guide element may comprise a loop of material that can be advanced through the intravascular access device. In the example shown in FIG. 3A, the guide element 106 may have a first side 106a and a second side 106b of an elongate body. Thus, either side 106a or 106b may be advanced to create a loop 120 that can be advanced into the blood vessel. For example, the loop 120 may roll outward distally as one or both sides of the guide element 106 are advanced distally. FIG. 3B is a detailed view of the distal end of an intravascular access device showing an example guide element 106. Neither the proximal nor distal ends of the guide element are shown. However, the guide element can be understood to be positioned at least partially within the needle aperture and partially within the working space of the intravascular access device 100 .In this configuration, the guide element may be selectively advanced such that the operator can advance the guide element distally from the intravascular access device through the needle aperture, through the working space, or some combination of both. For example, the intravascular access device may be positioned inside a blood vessel, and the operator may first attempt to advance the guide element distally through the working space, then advance the guide element through the needle aperture to guide the advancement of the guide element through the vasculature, and then the operator may advance both the working space side of the guide element and the needle aperture side of the guide element simultaneously. In some examples, distally advancing both sides (e.g., both ends) of the guide element can create a loop or adjust the size of the loop created as the guide element is advanced distally from the intravascular access device. For example, when both sides of the guide element are advanced, the size of the loop can increase because the guide element body can bias the guide element toward an open position at the loop, thereby increasing the loop size.

[0028]

[0045] As mentioned above, Figure 4 illustrates the transition from the retracted position to the advanced position, in which the first side 126 of the guide element 106 is advanced, and the needle 115 remains stationary while the guide element is advanced through the working space 130. Notably, the working space 130 is visible, and the intravascular access device 100 is oriented to reveal the needle flat 135, which extends partially outward from the catheter distal end 140. It can be seen that the needle flat serves as a platform for the portion of the guide element 106 that is positioned within the working space 130. Although not explicitly shown, the interior of the catheter may be a continuous circular interior surface that, together with the flat needle surface 135, forms the working space 130.

[0029]

[0046] 5A and 5B show examples of guide elements described herein having a formed distal tip 145. The guide element distal tip may be defined by a portion of the guide element (e.g., the distal end or distal end section) or by a formed distal tip. The formed distal tip of the guide elements described herein can include a distal tip welded or otherwise attached to the distal tip of the guide element. In FIG. 5A, the formed distal tip 145 may be molded with the guide element during initial manufacturing or affixed to the guide element at a later time. In some examples, the formed distal tip can be a modified distal tip, where the distal tip of the guide element is modified to a certain shape or configuration. The example shown in FIG. 5A has a formed distal tip 145 that essentially finishes the needle distal tip geometry to a cylindrical or tubular shape that tapers from near the distal end of the needle (e.g., near the needle tip) to the distal end of the catheter 143. In this configuration, impact of the distal end of the intravascular access device is reduced as it penetrates and traverses the anatomy and blood vessels of a patient's anatomy, thereby reducing penetration force. FIG. 5B shows a similarly shaped distal tip 145 of a guide element 150 highlighting the distal end of the guide element 150 having two or more annular elements 155 (e.g., body sections) extending proximally therefrom. In particular, FIG. 5B illustrates a guide element having two annular elements 155 comprising a guide element body. As described herein, a guide element having a body comprised of multiple annular elements enhances the function of the guide element. For example, as the guide element 150 is advanced distally into the vasculature, both annular elements 155 can be advanced simultaneously, maintaining a generally parallel guide element path relative to one another. In some instances, less than all of the annular elements 155 can be advanced to facilitate selective directional control of the guide element 150 (e.g., the guide element distal tip). For example, if the operator advances both annular elements simultaneously, the guide element can be advanced distally into the vasculature.If the operator advances less than all of the annular elements 155 at a time, the distal end of the guide element may deflect or bend in one direction. In some examples, the guide element 150 may deflect or bend in the opposite direction from the advancing annular elements. In some examples, as the distal end of the guide element is advanced through the vasculature, the operator can selectively retract less than all of the guidewire annular elements to steer or deflect the distal end of the guide element. In some examples, the distal section of the guide element is molded, welded, formed, or configured for a specific function.

[0030]

[0047] The guide elements described herein may include one or more sections, segments, portions, or regions having different materials and / or material properties. For example, the guide elements described herein may include an elongated member extending from a proximal end to a distal end or region, and a conformable tip may be coupled to the distal end of the elongated member. For example, the guide elements described herein may have a wire (e.g., an elongated / annular member) extending from the proximal end to the distal end, to which a plastic, polymer, and / or other acceptable moldable material is coupled. In some examples, the distal region may be molded, welded, glued, or otherwise affixed to the distal end or region of the guide element body. In some examples, the conformable tip (e.g., distal region / end) of the guide element may be fabricated on the elongated member body of the guide element. In some examples, the elongated member body of the guide element may have one or more features (e.g., tabs, prongs, groves, grips, etc.) configured to retain the conformable tip coupled thereto. In some examples, the elongate body of the guide element may be a wire or similar element having suitable column strength to advance or otherwise control the guide element during use.

[0031]

[0048] 5B further illustrates an example of the enhanced functionality of the guide element described herein. Each of the annular elements 155 bends or flexes away from one another in a spring-biased manner to form a bubble or opening that can expand as the guide element is advanced further outward from the intravascular access device. Expansion of these annular elements in this manner enlarges or otherwise widens the vascular opening, aiding the patient and / or operator during the procedure. In some examples, the formed distal tip 145 may refer to a nose core or core section that includes the distal end of each annular element 155 within or affixed to the nose or distal tip of the guide element 150.

[0032]

[0049] As described herein, the guide element may include an atraumatic tip. Figures 6A and 6B show an example of a guide element 123 with a rounded or looped tip 127 formed at its distal end or distal section, such that the tip is configured to protect the guide element during vascular insertion by having a catheter tip mate therewith, thereby allowing the element to emerge from the distal tip of the catheter after vascular insertion. The catheter 112 is shown substantially transparent to highlight the position of the guide element within the working space. Thus, the annular element 155 of the guide element 123 is configured to be slidably advanced or retracted within the working space 130 between the flat face of the needle and the interior of the catheter. Here, Figure 6A shows an example of a guide element in an extended or advanced configuration beyond the distal end of the intravascular access device 100, and Figure 6B shows the guide element 123 in a retracted configuration, with the entire distal end of the guide element retracted and positioned within the catheter 112. Additionally, the distal end of catheter 112 is shown in contact with the outer surface of the needle, including contact with an outer needle flat, which may be understood to extend beyond the distal end of catheter 112. Included in Figure 6C is an exploded view of a cross section of needle 115 and annular element 155 of guide element 123, without the catheter. In particular, the needle flat extends around a section of the needle's circumference while providing needle aperture 157.

[0033]

[0050] In some embodiments, the guide element may be held in a ready configuration or position within the distal end of the intravascular access. For example, the guide element may continue to be held in a ready configuration within the catheter before, during, and / or after the intravascular access device is inserted into the patient's vasculature. The needle can slide distally and / or proximally in this configuration without disturbing the position of the guide element. Similarly, the catheter may also be advanced or retracted along the needle while the guide element continues to be held in the ready configuration. For example, as described herein, the guide element may be held within the working space, but the needle may first be advanced or extended distally in preparation for tissue penetration, and the guide element may be held within the working space by the tapered catheter distal end.

[0034]

[0051] The guide element structure may be configured or have a geometry to complement the workspace, needle planar surface, catheter interior surface, needle aperture, needle distal end, needle distal tip, procedural parameters, guide element function, guide element maneuverability, etc. For example, the guide element may be geometrically configured to conform to the needle exterior, and the needle exterior may be curved such that the guide element cross-sectional geometry is concave to complement the curved exterior of the needle. In other examples, the needle planar surface may be complemented by one or more of the guide element annular elements having corresponding flat surfaces. In some examples, the respective geometries of the annular elements may complement each other so that the annular elements maximize the volume occupied by the guide element within the intravascular access device. In some examples, the geometries of the annular elements may complement each other so that the annular elements promote optimized maneuverability and function of the guide element. In some examples, the guide element may have two or more annular elements, which may be generally cylindrical (e.g., circular cross-section). In some examples, the dimensions of the guide element and / or each annular element may take into account its function or deployment route through the intravascular access device. For example, the annular elements may have a diameter between 0.0055 inches and 0.0075 inches. In some examples, each annular element may have a width between 0.0060 inches and 0.0070 inches. In some examples, the width of an annular element may be 0.0065 inches. In some examples, the width of an annular element may be relative to the width of one or more other annular elements of the same guide element. In some examples, the width of the annular element is 0.01905 mm (0.00075 inches), 0.0254 mm (0.001 inches), 0.03175 mm (0.00125 inches), 0.0381 mm (0.0015 inches), 0.04445 mm (0.00175 inches), 0.0508 mm (0.002 inches), 0.05715 mm (0.00225 inches), 0.0635 mm (0.0025 inches), 0.06985 mm (0.00275 inches), 0.0762 mm (0.003 inches), 0.08255mm (0.00325 inch), 0.0889mm (0.0035 inch), 0.09525mm (0.00375 inch), 0.1016mm (0.004 inch), 0.10795mm (0.00425 inch), 0.1143 (0.0045 inch), 0.12065mm (0.00475 inch), 0.127mm (0.005 inch), 0.13335 (0.00525 inch), 0.1397mm (0.0055 inch), 0.14605mm (0.00575 inch), 0.1524mm (0.006 inch), 0.15875 mm (0.00625 inch), 0.1651 (0.0065 inch), 0.17145 mm (0.00675 inch), 0.1778 mm (0.007 inch), 0.18415 mm (0.00725 inch), 0.1905 mm (0.0075 inch), 0.19685 mm (0.00775 inch), 0.2032 mm (0.008 inch), 0.20955 mm (0.00825 inch), 0.2159 mm (0.0085 inch), 0.22225 mm (0.00875 inch), 0.2286 mm (0.009 inch), 0.23495 mm (0.00925 inch), 0.2413mm (0.0095 inch), 0.24765mm (0.00975 inch), 0.254mm (0.01 inch), 0.26035mm (0.01025 inch), 0.2667mm (0.0105 inch), 0.27305mm (0.01075 inch), 0.2794mm (0.011 inch), 0.28575mm (0.01125 inch), 0.2921mm (0.0115 inch), 0.29845mm (0.01175 inch), 0.3048mm (0.012 inch), 0.31115mm (0 .01225 inch), 0.3175mm (0.0125 inch), 0.32385mm (0.01275 inch), 0.3302mm (0.013 inch), 0.33655mm (0.01325 inch), 0.3429mm (0.0135 inch), 0.34925mm (0.01375 inch), 0.3556mm (0.014 inch), 0.36195mm (0.01425 inch), 0.3683mm (0.0145 inch), 0.37465mm (0.01475 inch), 0.381mm (0.015 inch), 0.38735mm (0.0.01525 inch), 0.3937 mm (0.0155 inch), 0.40005 mm (0.01575 inch), 0.4064 mm (0.016 inch), 0.41275 mm (0.01625 inch), 0.4191 mm (0.0165 inch), 0.42545 mm (0.01675 inch), 0.4318 mm (0.017 inch), 0.43815 mm (0.01725 inch), 0.4445 mm (0.0175 inch), 0.45085 mm (0.01775 inch), 0.4572mm (0.018 inch), 0.46355mm (0.01825 inch), 0.4699mm (0.0185 inch), 0.47625mm (0.01875 inch), 0.4826mm (0.019 inch), 0.48895mm (0.01925 inch), 0.4953mm (0.0195 inch), 0.50165mm (0.01975 inch), 0.508mm (0.02 inch), 0.51435mm (0.02025 inch), 0.5 207mm (0.0205 inch), 0.52705mm (0.02075 inch), 0.5334mm (0.021 inch), 0.53975mm (0.02125 inch), 0.5461mm (0.0215 inch), 0.55245mm (0.02175 inch), 0.5588mm (0.022 inch), 0.56515mm (0.02225 inch), 0.5715mm (0.0225 inch), 0.57785mm (0.02275 inch), 0.5842mm (0.023 inch), 0.59055 mm (0.02325 inch), 0.5969 mm (0.0235 inch), 0.60325 mm (0.02375 inch), 0.6096 mm (0.024 inch), 0.61595 mm (0.02425 inch), 0.6223 mm (0.0245 inch), 0.62865 mm (0.02475 inch), 0.635 mm (0.025 inch), 0.64135 mm (0.02525 inch), or more. In some examples, each annular element may have a different width. In some examples, two or more annular elements may have the same width.

[0035]

[0052] In some examples, the annular elements are in contact with or substantially adjacent to one another. For example, the annular elements may be generally parallel to one another along a section of the guide element. In some examples, the annular elements may be separated from one another by a gap (e.g., two annular elements may be separated by a gap of 0.1016 mm (0.004 inches)). In some examples, the guide element may have a wide cross-sectional width (e.g., two annular elements may have a gap of 0.4318 mm (0.017 inches) between them).

[0036]

[0053] The guide element may be used with an intravascular access device having a catheter 160 with a catheter distal tip door 165 configured to facilitate transition of the guide element 105 from a ready configuration to an advanced or in-use configuration. Figures 7A and 7B show example longitudinal cross-sectional views of the distal end of an intravascular access device 100 (e.g., a catheter of an intravascular access device) and a guide element having a curled distal end 108 that curls over the needle distal tip. The guide element extends outward from a working space 130 between the catheter 160 and the outer needle surface. The needle flat 135 extends along the needle body to the needle distal tip, and the catheter distal tip 165, configured to accommodate transition of the guide element from within the working space distally into the blood vessel, is shown in an open position, biased open by the passage of the advanced guide element loop 108 therethrough.

[0037]

[0054] In some examples, the distal end, portion, section, etc. of the catheter may be configured to expand or have increased elasticity or flexibility to allow the guide element to extend distally from within the catheter into the interior of the blood vessel. For example, the region adjacent the distal tip of the catheter may include a material having a lower durometer rating than the proximal portion or section of the catheter. In this manner, the catheter may have a distal opening configured to contact the outer surface of the needle when initially inserted into the blood vessel. Then, after the catheter has been inserted, the guide element may be advanced distally from within the working space, causing the distal circumference of the catheter to expand or flex, thereby allowing the guide element to pass through the catheter distal circumference and enter the blood vessel. In some examples, the catheter distal circumference may be configured to contact around the outer surface of the needle. In some examples, the catheter distal circumference may be configured to contact around the outer surface of the needle and the outer surface of the guide element when the guide element is advanced into the blood vessel. The extended configuration is shown in Figure 7B, where the guide element is extended to a length 109 beyond the needle tip while maintaining a curled distal end 108. The catheter distal door is a slit or other opening that allows the guide element to pass through while maintaining the maximum amount of continuous contact around the needle circumference. From these cross-sectional views, it can be seen that the guide element may extend through a slit in the distal end of the catheter, through a resilient circumference in the distal end of the catheter, or a combination thereof.

[0038]

[0055] In some examples, a catheter may include one or more materials, such as silicone rubber, nylon, polyurethane, polyethylene terephthalate (PET), latex, polyimide, thermoplastic elastomer, etc. Any of the catheters described herein may include a region (e.g., a section, portion, area, feature, etc., having increased flexibility relative to another section, portion, region, area, feature, etc.). For example, the durometer rating of a catheter or catheter region may be measured according to the Shore 00, Shore A, or Shore D scale. In some examples, the durometer rating of a catheter or catheter region can be 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, or more, or any value therebetween, according to the Shore 00, Shore A, or Shore D scale. For example, the elongate body of the catheter may have a higher durometer rating compared to the distal end, the distal circumference, the deployment slit(s), etc., or a combination thereof. For example, the elongate body of the catheter may be Shore A40, while the distal region of the catheter (eg, the distal circumference) may be Shore A20.

[0039]

[0056] In some examples, the catheter may include one or more materials such as silicone rubber, nylon, polyurethane, polyethylene terephthalate (PET), latex, polyimide, thermoplastic elastomer, etc. Any of the catheters described herein may include a region (e.g., a section, portion, area, feature, etc.) having increased resiliency relative to another section, portion, region, area, feature, etc.) For example, the catheter distal end, distal region, distal circumference may have increased resiliency configured to expand the distal opening and allow the guide element to be advanced distally from the working space.

[0040]

[0057] In some examples, the guide element may have shape memory for one or more of the annular elements. Figures 8A through 8E show examples of shape memory for one or more of the annular elements of the guide element. The shape of the guide element along a segment of its body or near its distal end can be beneficial in terms of the function and operation of the guide element during a procedure. In some examples, the guide element may be initially held in a straight or substantially straight shape in a ready or retracted configuration. When the guide element is advanced distally from the intravascular access device, the shape memory may assume any configuration that has been predetermined and imparted to the guide element and / or components of the guide element.

[0041]

[0058] Referring to FIG. 8A and in some examples, the guide elements described herein may include an atraumatic tip at the distal end of the elongate body. Here, the elongate body includes two members 190a and 190b. In some examples, members 190a and 190b may be advanced simultaneously or at different speeds relative to each other. If they are advanced at different speeds (e.g., member 190a is advanced faster than member 190b), the atraumatic tip 190 may be a different section of the overall length of the guide element such that the atraumatic tip characteristics are maintained throughout the length of the guide element forming the guide element. In FIG. 8B, this example guide element includes a loop 195 as the atraumatic distal end, which includes a section of the guide element that curls after being advanced from the catheter. For example, the elongate body 200 can be coaxial with the distal tip of the guide element when retracted within the catheter, and then the distal section 195 can curl when the guide element is advanced beyond the needle tip. FIG. 8C illustrates an example of a guide element elongate body shape change. Here, an atraumatic tip 205 can be positioned at the distal end of two non-linear members 205a and 205b that comprise the elongate body. Thus, in some examples, the guide elements described herein can have properties and attributes to improve navigation through a blood vessel or can provide additional assistance and functionality, such as dilating the vessel or addressing obstructions, when advanced into the vessel. FIG. 8D illustrates another example of a guide element with a hook end 211, where the distal end 210 does not fully curl around the distal region of the guide element. In some examples, as shown in FIG. 8E, the guide element can be considered based on different sections or regions of the guide element. For example, the proximal region 215 can include materials with different stiffnesses or compositions to provide columnar support and strength as the guide element is advanced. Region 215 can also include shape memory or material compositions configured to facilitate changes in the form and function of the guide element. Finally, the distal end 217 may be configured to provide an atraumatic tip or other features or improved deployment and navigation.Yet another example of a guide element is shown in FIG. 8F , which includes a distal curl 196 at the end of the elongate body 201. Here, the curl can be 360 ​​degrees or more. In some examples, the guide element may include a distal end with multiple curls at the distal end. Thus, the distal end may be configured to provide increased flexibility, such as a spring, when navigating tortuous blood vessels.

[0042]

[0059] 9A through 9D show further examples of guide elements described herein. In FIG. 9A, an example cross-section of a guide element segment shows multiple annular elements (e.g., 220 and 221) arranged in a generally linear fashion relative to one another as they may be on top of the needle flat in the working space before, during, or after distal advancement. Their cross-sectional geometry is generally circular, but may be any geometry that can facilitate control and manipulation of the guide element and / or the guide element distal end or tip during the procedure. With multiple annular elements (e.g., multiple annular elements with the same or different properties), there may be additional capabilities for controlling and manipulating the guide element. For example, two central annular elements 221 may enable vertical control or steering of the guide element within a vessel or may allow for increased structural integrity when advancing the guide element through the vasculature. The outer annular elements 220 may provide lateral control. For example, initially advancing the guide element distally may be accomplished by advancing any one or all of the annular elements, and then the operator can steer the distal tip to one side or another by retracting or advancing the outer annular element 220. Figure 9B shows another example of a guide element variation described herein having a molded or affixed distal tip 515. The example shown in Figure 9B has multiple annular elements 225a and 225b. However, molded or affixed distal dips on the guide element may be located on the distal end of a single elongate body (e.g., annular element) or multiple annular elements (e.g., 225a and 225b). As shown in Figures 9C and 9D, the guide element distal tips 204 and 246 may be capable of rotation up to 180 degrees based on manipulation of one or more annular elements. For example, one or more annular elements may actuate a transition from a straight guide element configuration to a curled, atraumatic distal tip. 9C and 9D, the guide elements may be made of braided materials. For example, FIG. 9C shows a length 230 of an elongate body 235 that may be a woven or braid-like structure.In some examples, the woven or braided structure of the guide element may be coated or covered (e.g., with a biocompatible polymer, metal, etc.). In some examples, the guide elements described herein may have a curled or curved atraumatic distal tip that can change from a first position (e.g., a straight shape in a ready configuration) to a second position, whereby the distal tip curls, bends, loops, or otherwise changes from a straight shape at or near the distal tip when the guide element is advanced beyond the distal end of the intravascular access device. For example, FIG. 9D shows multiple loops or curls in the distal region 245 of the guide element. In some examples, the distal end of the guide element may be curled, looped, or otherwise in a non-straight configuration within the intravascular access device before being advanced (e.g., in a ready-to-use configuration).

[0043]

[0060] FIG. 10A illustrates an example of a guide element and intravascular access device described herein. The distal end of the intravascular access device 100 is shown in a longitudinal cross-section highlighting the retracted or ready configuration of the guide element 105 within the working space 130 between the needle 115 (e.g., needle flat) and the inner surface of the catheter 112. The working space may be located anywhere longitudinally along the length of the needle and catheter at the distal end of the intravascular access device relative to the placement and orientation of the needle flat. For example, FIG. 10A illustrates a needle 115 with the distal tissue-piercing tip aligned in such a position that the guide element will advance distally along the longest length of the needle 115 until it has advanced beyond the tissue-piercing tip. The flat may be located longitudinally along the needle body at any position (e.g., radially or clockwise relative to the needle axis). In some examples, there may be two or more working spaces, whereby the needle of the intravascular access device can have two or more flat surfaces (e.g., square or other polygonal geometric shapes) to create a working space with each flat surface and the inner surface of the catheter.

[0044]

[0061] In FIG. 10B , an intravascular access device described herein is shown with a catheter including a distal end with a deployment slit 250 (e.g., a catheter distal tip door). The deployment slit 250 may be configured to facilitate advancement or other manipulation of the guide element from within the working space when the guide element is advanced distally from the intravascular access device. For example, the guide element may be advanced distally against the catheter distal end with sufficient force or pressure to open or separate the deployment slit 250 and then extend or be able to advance beyond the distal end of the catheter. In some examples, the catheter distal slit may be a single slit or multiple slits. In some examples, the placement of the deployment slit 250 may be related to the location or placement of the intravascular access device working space. For example, the deployment slit 250 may be aligned with the distal end of the working space. In some examples, multiple deployment slits may be positioned relative to one another (e.g., as described above) to form a flap or catheter distal tip door. In some examples, the distal end of the catheter is resilient and can conform to the contours of the outer surface of the needle in a ready configuration (e.g., when the needle and catheter are inserted into a blood vessel). In some examples, as the guide element is advanced through the working space, the catheter distal end can expand against an elastic retraction force against the needle flat surface to create a seal around the advanced guide element and needle, thereby preventing unwanted flow of fluid (e.g., blood from within the blood vessel through the catheter working space).

[0045]

[0062] In some examples, the deployment slit can be a line or lines of perforations disposed around the distal end of the catheter to allow or facilitate passage of the guide element distal tip as it transitions from the retracted configuration to the deployed configuration. In some examples, the deployment slit or slits can represent lines or areas of increased flexibility so that the catheter outer surface remains continuous, but further, the deployment slits can be configured to expand to allow the guide element to transition from the retracted configuration to the deployed configuration.

[0046]

[0063] The deployment slit configuration can include the orientation of the slit from the distal end of the catheter. For example, Figures 11A through 11C show deployment slits of various angles or configurations at or near the distal end of the catheter to facilitate the advancement of a guide element or another tool from within or out of an intravascular access device (e.g., a working space). In some examples, the deployment slit can further facilitate one or more annular elements of the guide element. For example, as seen in Figure 4, where the guide element may extend within or through the needle aperture and continue through the working space, the deployment slit can facilitate the transition of the guide element (e.g., one or more of the annular elements) from the needle aperture into or through the working space.

[0047]

[0064] Referring to FIG. 11A, deployment slit 251 is angled and configured to provide a minimal opening around the circumference of the distal end of the catheter. In some examples, a passageway, flap, door, or the like can be created when a guide element is advanced against deployment slit 251. Similarly, in FIG. 11B, deployment slit 252 is angled so that the distal end of the flap or opening is larger around the circumference of the catheter distal end. In some examples, the geometry of the deployment region or area at the catheter distal end may be configured to accommodate the distal end of a tool or guide element having a complementary geometry. For example, a guide element or tool advanced distally from within a catheter with a larger distal tip can benefit from a catheter such as the catheter shown in FIG. 11B, which has a larger opening or elastic region around the distal circumference of the catheter. Finally, FIG. 11C shows yet another example of a guide element deployment area on the distal end of catheter 113 with parallel deployment slits 253 that provide a region or flap configured to facilitate distal advancement of the guide element distal tip from within the catheter.

[0048]

[0065] In some examples, any of the catheters described herein can include a continuous distal end, whereby a section, region, periphery, or area of ​​the catheter distal end can be configured to allow distal advancement of a guide element from within the catheter without disturbing the continuous outer surface of the catheter. For example, the flap or door provided by the deployment slit described herein can represent an area of ​​reduced structural integrity or increased resilience that allows the catheter distal end to deploy a guide element from within the catheter while maintaining substantial contact with the outer surface of the needle and the guide element extending therethrough. For example, in any of the catheters described herein, the distal end can be configured to facilitate deployment of a guide element without disturbing the structure of the catheter itself.

[0049]

[0066] In any example, the deployment region (e.g., a deployment slit, door, flap, elastic region, elastic surround, distal region, etc., having a lower durometer rating) may be configured to facilitate the introduction of a tool or other interventional device deployed from within the catheter through a working space between the outer surface of the needle (e.g., the needle flat) and the inner surface of the catheter. For example, a cutting device, a suction device, an imaging device, a light source, a balloon, etc. may be deployable from within the catheter.

[0050]

[0067] 12A and 12B show example transitions for a guide element including a deployment slit or catheter distal door created by two or more deployment slits. For example, FIG. 12B shows guide element 200 extending outward from deployment opening 256 while the curled tip of the guide element advances forward and distally past needle 115. With reference to FIG. 12A, the guide element is in a stored or ready-to-use configuration prior to deployment from within catheter 113 and the working space therein. In FIG. 12B, guide element 200 is advanced distally through opening 256 and continues to remain beyond needle 115.

[0051]

[0068] Similarly, the longitudinal cross-sectional views of Figures 13A and 13B show an example of a resilient distal end 275 or section of catheter 271. The distal end of catheter 276 contacts the outer surface of needle 115 in Figure 13A, such that guide element 123 is held within the working space and in a retracted configuration. Then, in Figure 13B, guide element 123 is deployed against resilient surround 276, such that the catheter surround now contacts the outer surface of the needle and the outer surface of the guide element extending therethrough.

[0052]

[0069] In some examples, the deployment feature is a distal tip or region of the catheter having a deployment feature (e.g., a catheter door / deployment slit) to facilitate transition, advancement, or other function of an intravascular device (e.g., a guide element). In some examples, the deployment feature is a configuration of slits that can provide a deployment slit, or a door, flap, or another means of selectively opening the catheter distal lumen to allow the guide element and / or needle to extend therethrough. In some examples, the deployment feature can be a region of the catheter's expandable (e.g., resilient or compressible) distal lumen that can be biased around the outer periphery of the intravascular access device (e.g., a needle), which can seal or confine the working space until the guide element is advanced through the deployment feature. For example, the guide element can be positioned within the working space and advanced against compression of the catheter's distal lumen (e.g., deployment feature) to sufficiently expand the opening to allow the guide element to advance therethrough. In some examples, the catheter's distal lumen (e.g., deployment feature) can conform to the outer periphery of the intravascular access device, including the periphery of the guide element extending therethrough.

[0053]

[0070] In some examples, the catheter distal end or tip may have a conforming section for conforming to the distal tip of the guide element. The guide element has a formed or connected distal tip with a geometry that is complemented by the conforming section of the catheter distal tip. In such a configuration, the guide element distal tip may be in a ready-to-use configuration when the distal tip is seated on the catheter conforming distal section. Figures 14A, 14B, and 14C provide further illustrative examples of guide element annular element configurations that take into account the needle 115. The number of annular elements, their arrangement, and annular element size may be based on or related to the dimensions of the workspace (e.g., the length or surface of the needle flat and / or the volume of the workspace created by the needle flat and the interior of the catheter). For example, while Figure 14A shows two annular elements 280, Figure 14B shows a single annular element 281 having an oval cross-sectional geometry, and yet another example of multiple annular elements 282 is shown by Figure 14C. 14B shows further details of an example guide element bonding or attachment, including the guide element distal tip. Shown here is an example guide element affixed, bonded, or otherwise engaged to a formed distal tip. The guide element distal tip can be formed into an atraumatic geometry to provide increased safety and improved maneuverability within the vessel.

[0054]

[0071] Yet another example of a guide element configuration is shown in FIGS. 15A-15C. In FIG. 15A, the distal section of the guide element is shown with a distal tip 290 molded or affixed to the distal end of an elongate body 292 comprising two annular elements. Proximal to the distal tip 290 is an engagement feature 291 configured to seat within a corresponding feature or element of a catheter distal tip. Referring to FIG. 15B, the guide element distal tip 290 is visible in the ready position and within a corresponding feature or notch of the catheter distal end. Here, the guide element distal tip 290 is further shown configured to provide a smooth transition at the catheter distal end. For example, the guide element distal tip 290 may be configured to seat or otherwise engage the distal end of the catheter in a manner that completes the distal circumference or perimeter of the catheter distal end. In this way, when the catheter 196 is inserted into a blood vessel, the amount of expansion required for insertion is minimized. Further, in Figure 15B, the guide element distal tip 290 is seated in a conforming section of the catheter distal tip, and then as the guide element is advanced, the distal tip moves distally from the conforming section of the catheter tip and beyond the needle. Then, in Figure 15C, the guide element distal tip 290 has been advanced from the catheter feature 295 and can be advanced into the blood vessel.

[0055]

[0072] FIG. 16 shows an example of a guide element in use when deployed from within a working space by an intravascular access device 300. The intravascular access device 300 has a handle 305 and a sliding device 310 in operative communication with the guide element 123. A catheter 315 extends from a catheter hub 316 coupled to the distal end of the intravascular access device 300. A close-up of the catheter distal end shows the catheter 123 in a retracted position outside the needle 115 and within the working space inside the catheter 315. In this example, the catheter distal end 315a may be an example of a region having increased resiliency, a reduced durometer rating, or may otherwise be configured to contact around the outside of the needle, i.e., until the sliding device 310 is advanced, thereby advancing the guide element 123 distally along the outer surface of the needle 115 and through the catheter distal end 315a. As the sliding device 310 and guide element 123 are advanced, the guide element distal end contacts the inside of the catheter distal end 315, expanding or otherwise deploying the catheter distal end 315a from the catheter 315. Thus, in some examples, the catheter distal end 315a can maintain contact with the guide element 123.

[0056]

[0073] In some examples, the distal end of the guide element may be configured as a spring. For example, a curve or looping in the distal section of the guide element can provide increased structural integrity compared to a partially looped distal section, making the distal section more compressible around the curve. In some examples, the curve or loop can provide a spring that can absorb forces or contact between the guide element distal end and the patient's anatomy.

[0057]

[0074] In some examples, the guide element can have multiple annular element segments. In some examples, the annular element segments define the length of the guide element from the distal segment of the guide element to the proximal portion of the guide element. For example, there can be four annular element segments. In some examples, there can be one annular element segment, two, three, four, etc., up to a quantity of annular element segments sufficient to facilitate optimized function and operation of the guide element and associated intravascular access device. In some examples, the number of annular element segments can relate to the maneuverability of the guide element as it advances. For example, one or more of the annular element segments can be selectively displaced based on a desired travel or recognition of an obstacle within the vasculature.

[0058]

[0075] In some examples, the distal end of the catheter may have a continuous circumferential split that is selectively opened by advancing a guide element through the distal end of the catheter. The orientation of the split or slit may be based on the configuration of the guide element distal geometry, the deployment function of the guide element, the size of the guide element, the vessel or vascular site where the intravascular access device is to be deployed, the distal tip of the guide element, or more.

[0059]

[0076] Some examples of materials comprising the guide element, or guide element segments, can include Nitinol, PEEK, or another material that has sufficient hardness and rigidity to aid advancement through the vasculature. Additionally, the material may have a memory that allows a shape to be imparted to the material through molding or other forming means such that the shape is restricted in a retracted state and the shape is restored after the shaped portion is advanced from the IV device / system.

[0060]

[0077] In some examples, the guide element and / or one or more of the guide element components may include one or more alloys. In some examples, the alloy composition of the guide element may vary in different areas of the section along the length of the guide element or in various sections of the guide element. For example, the distal end may include one or more alloys configured to conform, adjust, or otherwise change the shape or orientation of the alloy section. For example, the distal tip may be a first alloy, a section adjacent to the distal tip may be a second alloy, and a section adjacent thereto may be a third alloy. The second alloy may have different properties from the first and third alloys, causing the second alloy section to change, conform to, or interact differently with different environmental factors to cause a predetermined or desired change in the configuration and orientation of the guide element distal end. In some examples, the alloy section may contract at a faster rate in the presence of a lower temperature compared to other alloys, resulting in a predetermined curvature or bend in the section. In some examples, the guide element may have two or more annular segments, and each annular segment may have a different alloy and / or may be made of a material with different properties, such as stiffness, malleability, hardness, conductivity, etc. For example, one annular element may include a material that is hard enough to allow the guide element to be advanced through the occlusion without bending or kinking, while a second annular element may have a lower stiffness that may cause the guide element to bend if advanced only with the softer annular element. In such a configuration, the softer annular element may act as a test element when advancing the guide element through the vasculature, thereby allowing the amount of force required to advance the guide element through the occlusion to be tested.

[0061]

[0078] The guide elements (e.g., guidewires and related structures) described herein may be used during a medical procedure (e.g., intravascular access) and / or in association with an intravascular access device. The intravascular access devices (e.g., any elements of an intravascular access device) described herein may be used and / or associated with a medical procedure.

[0062]

[0079] There may be one or more variations, alternatives, structures, compositions, and / or components described herein that may be used to modify the guide element, intravascular access device, and / or related structural or process elements, components, devices, systems, processes, etc. Accordingly, any variations, descriptions, examples, elements, components, processes, methods, method steps, etc. described herein may be used as a modification, variation, and / or alternative to any elements, devices, systems, compositions, examples, components, processes, methods, method steps, etc. described in PCT Application No. PCT / US23 / 65556, filed April 7, 2023, entitled "INTRAVASCULAR CATHETER WITH INTEGRATED GUIDE STRUCTURE," and / or PCT Application No. PCT / US21 / 54046, filed October 7, 2021, entitled "INTRAVASCULAR CATHETER WITH INTEGRATED GUIDE STRUCTURE," both of which are incorporated herein in their entireties.

[0063]

[0080] It should be understood that all combinations of the foregoing concepts, and additional concepts discussed in more detail below (provided such concepts are not mutually inconsistent), are contemplated as being part of the inventive subject matter disclosed herein and may be used to obtain the benefits described herein.

[0064]

[0081] As used herein, when a feature or element is referred to as being "on" another feature or element, the feature or element may be directly on the other feature or element, or there may be intervening features and / or elements. In contrast, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features or elements present. When a feature or element is referred to as being "coupled," "attached," or "bonded" to another feature or element, it will be understood that the feature or element may be directly coupled, attached, or bonded to the other feature or element, or there may be intervening features or elements present. In contrast, when a feature or element is referred to as being "directly coupled," "directly attached," or "directly bonded" to another feature or element, there are no intervening features or elements present. Although described or illustrated with respect to one embodiment, the features and elements so described or illustrated may also apply to other embodiments. Those skilled in the art will also understand that a reference to a structure or feature being located "adjacent" another feature may have portions that overlap or underlie the adjacent feature.

[0065]

[0082] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the invention. For example, as used herein, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that as used herein, the terms "comprises" and / or "comprising" specify the presence of stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as " / ."

[0066]

[0083] Spatially related terms such as "below," "lower," "below," "above," "upper," and the like may be used herein to describe the relationship of one element or feature to another element or feature shown in the figures for ease of description. It will be understood that spatially related terms are intended to encompass different orientations of the device during use or operation in addition to the orientation shown in the figures. For example, if a device in a figure were inverted, an element described as being "below" or "directly below" another element or feature would be oriented "above" the other element or feature. Thus, the exemplary term "below" may encompass both an above and below orientation. A device may be oriented in other ways (rotated 90 degrees or at other orientations), and the spatially related descriptors used herein will be interpreted accordingly. Similarly, unless specifically indicated otherwise, the terms "upward," "downward," "vertical," "horizontal," and the like are used herein for descriptive purposes only.

[0067]

[0084] Although the terms "first" and "second" may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms unless the context clearly indicates otherwise. These terms may be used to distinguish one feature / element from another. Thus, a first feature / element discussed below may be referred to as a second feature / element, and similarly, a second feature / element discussed below may be referred to as a first feature / element, without departing from the teachings of the present invention.

[0068]

[0085] Unless the context requires otherwise, throughout this specification and the claims that follow, the word "comprise," and variations such as "comprises" and "comprising," mean that various components may be employed together in methods and articles (e.g., compositions and apparatuses, including apparatus and methods). For example, the term "comprising" is understood to imply the inclusion of any stated elements or steps, but not the exclusion of any other elements or steps.

[0069]

[0086] Generally, any of the devices and methods described herein should be understood to be inclusive, although all or a subset of the components and / or steps may alternatively be exclusive and may be expressed as "consisting of," or alternatively, "consisting essentially of," various components, steps, subcomponents, or substeps.

[0070]

[0087] As used herein in the specification and claims, including when used in the examples, and unless expressly specified otherwise, all numbers may be read as if preceded by the word "approximately" or "about," even if the term does not explicitly appear. The phrase "approximately" or "about" may be used when describing a size and / or location to indicate that the stated value and / or location falls within an expected reasonable range of values ​​and / or locations. For example, a numerical value may have a value that is + / - 0.1% of the stated value (or range of values), + / - 1% of the stated value (or range of values), + / - 2% of the stated value (or range of values), + / - 5% of the stated value (or range of values), + / - 10% of the stated value (or range of values), etc. Unless the context indicates otherwise, any numerical value given herein should also be understood to include approximately that value or approximately that value. For example, if the value "10" is disclosed, then "approximately 10" is also disclosed. Any numerical range stated herein is intended to include all subranges subsumed therein. As will be appreciated by those of skill in the art, when a value is disclosed, it is understood that "less than or equal to" that value, "greater than or equal to" that value, and possible ranges between values ​​are also disclosed. For example, if a value "X" is disclosed, "less than or equal to X" and "greater than or equal to X" (e.g., where X is a number) are also disclosed. It is understood that throughout this application, data is provided in a number of different formats, and this data represents endpoints and starting points, and ranges for any combination of the data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, it is understood that not only between 10 and 15, but also greater than 10 and 15, greater than or equal to 10 and 15, less than 10 and 15, less than or equal to 10 and 15, and equal to 10 and 15 are considered to be disclosed. It is also understood that each unit amount between two specific unit amounts is disclosed.For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0071]

[0088] While various exemplary embodiments have been described above, any of a number of changes may be made to the various embodiments without departing from the scope of the invention as set forth in the claims. For example, the order in which the various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments, one or more method steps may be omitted entirely. Optional features of the various apparatus and system embodiments may be included in some embodiments and not in other embodiments. Accordingly, the foregoing description has been provided primarily for illustrative purposes and should not be construed as limiting the scope of the invention as set forth in the claims.

[0072]

[0089] The examples and examples contained herein indicate, for purposes of illustration and not limitation, specific embodiments in which the subject matter may be practiced. As noted, other embodiments may be utilized or derived therefrom, such that structural and logical substitutions and changes may be made without departing from the scope of the present disclosure. Such embodiments of the inventive subject matter may be referred to herein by the term "invention," either individually or collectively, for mere convenience and without intending to intentionally limit the scope of this application to any single invention or inventive concept if more than one is actually disclosed. Thus, while specific embodiments have been illustrated and described herein, any configurations calculated to achieve the same purpose may be substituted for the specific embodiments shown. The present disclosure is intended to include any and all modifications or variations of the various embodiments. Combinations of the above embodiments, as well as other embodiments not specifically described herein, will be apparent to those skilled in the art upon consideration of the above description.

Claims

1. 1. A guide element for an intravascular access device, comprising: a catheter body having a distal end, a proximal end, and a lumen extending therethrough; an intravascular access device having a needle within the catheter lumen and a working space between an outer surface of the needle and an inner surface of the catheter, the working space configured to receive one or more tools therethrough; a guide element within the working space, wherein a portion of the catheter body adjacent the guide element is displaced in response to distal movement of the guide element along the needle within the working space; and Equipped with A guide element for an intravascular access device.

2. the portion of the catheter body is displaced in response to the guide element by moving a flap formed on the catheter body. The guide element according to claim 1 .

3. the portion of the catheter body being displaced by the guide element having a different durometer than the remainder of the catheter body; A guide element according to claim 2.

4. the portion of the catheter body having a different durometer that can be displaced by movement of the guide element is an annular portion of the distal-most portion of the catheter body. A guide element according to claim 3.

5. the portion of the catheter body having a different durometer that can be displaced by movement of the guide element is adjacent to the working space or within a semicircular portion corresponding to a flat portion of the needle; A guide element according to claim 3.

6. the catheter body having a first portion formed from a material of a first durometer and a second portion formed from a material of a second durometer; the first portion is adjacent to the workspace; the first durometer is selected such that, in use, the first portion deflects or deforms in response to a distal end of the guide element being advanced against the first portion. The guide element according to claim 1 .

7. 1. A guide element for an intravascular access device, comprising: an intravascular access device having a needle within a catheter lumen and a working space between an outer surface of the needle and an inner surface of the catheter, the working space being configured to receive one or more tools therethrough; a guide element having distal and proximal ends separated by one or more annular elements, the guide element configured to be advanced distally from the intravascular access device within a blood vessel, the one or more annular elements configured to control at least the distal end of the guide element; Equipped with A guide element for an intravascular access device.

8. and further comprising at least two annular elements, a first annular element configured to control a direction of movement of the guide element distal end. A guide element according to claim 7.

9. the distal end of the guide element is an atraumatic tip; A guide element according to claim 7.

10. the distal end of the guide element is a formed distal tip; A guide element according to claim 7.

11. The guide element is made up of a plurality of sections. A guide element according to claim 7.

12. further comprising at least one annular element; A guide element according to claim 7.

13. the needle has at least one flat, convex, or concave surface; the working space is defined by an inner arc of the catheter inner surface and the needle surface; A guide element according to claim 7.

14. the catheter distal tip includes one or more deployment slits aligned with the working space; A guide element according to claim 7.

15. the catheter distal tip comprises one or more conformable sections; a distal tip of the guide element configured to engage the one or more conformal sections; A guide element according to claim 7.

16. 1. An intravascular access device comprising: a handle having a proximal end and a distal end and a slot extending from said proximal end to said distal end; a catheter having a proximal catheter hub and a distal catheter lumen, the proximal catheter hub releasably engaged to the distal end of the handle; an access needle extending proximally from within the needle holder through the catheter lumen, the access needle having at least one flat surface extending longitudinally around a circumference of the access needle and a tissue-piercing tip extending distally beyond the catheter lumen; a working space within the catheter along the length of the access needle having a non-uniform circumferential cross-sectional geometry, the working space configured to facilitate passage of one or more tools therethrough distally from the proximal end of the intravascular access device into a blood vessel; a slider extending through the slot and in communication with the proximal end of the guide element such that distal advancement of the slider advances a distal tip portion of the guide element from a position within the guide element notch distally along the face of the access needle; Equipped with Intravascular access devices.

17. at least one flat surface of the access needle extends longitudinally along an outer surface of the access needle; 17. The intravascular access device of claim 16.

18. the at least one tool comprises a guide element; 17. The intravascular access device of claim 16.

19. the working space is defined by a needle flat surface and an inner surface of the catheter; the working space is selectively accessible from a proximal end of the intravascular access device; 17. The intravascular access device of claim 16.

20. the working space is configured to be selectively open at the catheter distal end; the workspace is configured to guide a tool or tool segment sliding therein; 17. The intravascular access device of claim 16.

21. further comprising an access needle lumen; The guide element may comprise a plurality of annular elements between a distal end and a proximal end; One or more of the annular elements may extend through the access needle lumen.

17. The intravascular access device of claim 16.

22. a hemostatic valve having a longitudinal groove around a periphery of the homeostatic valve; the hemostatic valve is located in the proximal catheter hub; 17. The intravascular access device of claim 16.

23. the access needle having a plurality of flat surfaces; each of the plurality of planar surfaces is associated with a separate working space within the catheter lumen; 17. The intravascular access device of claim 16.

24. an actuation button coupled to the needle holder; an actuation element that applies a force to the needle holder toward the proximal end of the handle; Furthermore, When the activation button is depressed, the activation element displaces the needle holder and access needle toward the proximal end of the handle.

17. The intravascular access device of claim 16.

25. The access needle is retracted proximally toward the handle, and the guide element is configured to remain in a distally advanced position.

17. The intravascular access device of claim 16.

26. a spool of guide elements in communication with the proximal end of the intravascular device; a length of the guide element is contained within the spool; 17. The intravascular access device of claim 16.

27. the guide element is made entirely or partly of a metallic material, a polymeric material, or a combination thereof; 17. The intravascular access device of claim 16.

28. the guide element comprises a plurality of sections; one or more of the plurality of sections comprises a different material; 17. The intravascular access device of claim 16.

Images