Guide element for endovascular access device

Abstract

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

Description

[0001] Priority claim

[0002] This patent application claims priority to U.S. Provisional Patent Application No. 63 / 408,419, filed on September 20, 2022, entitled "GUIDE ELEMENT FOR INTRAVASCULAR ACCESS DEVICE," which is incorporated herein by reference in its entirety.

[0003] Incorporated by Reference

[0004] All publications and patent applications mentioned in this specification are herein incorporated 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.

[0005] background

[0006] Venous access, such as venipuncture, is an essential element of a variety of medical procedures. Venipuncture generally refers to the process of obtaining access to a vein for any of a variety of purposes, including intravenous infusions, treatments, blood sampling, etc. For example, in hospitals, venipuncture is often used to place small vein catheters for delivery of intravenous fluids, drug delivery, blood sampling, etc.

[0007] While venipuncture and other forms of vascular access may be a simple matter in relatively healthy patients, such access is often required in patients who are unhealthy and may have small, tortuous, collapsed, fragile and / or difficult to locate arteries and / or veins. In such patients, venipuncture and other forms of vascular access can be very challenging, particularly for inexperienced phlebotomists, paramedics, nurses and other health care practitioners.

[0008] In addition to difficulty in establishing access, many vascular catheter placement systems may result in accidental punctures and / or accidental needle contamination during or after placement of an intravascular catheter. In addition, some conventional catheter placement devices employ relatively complex deployment handle movements, which results in increased cost and complexity. Furthermore, conventional handle placement and movement may obscure the presence and status of the needle and guide structure or guide element components of the tool, thereby making the use of the insertion tool less intuitive.

[0009] For these reasons, it is desirable to provide improved methods, systems and tools for deploying intravascular catheters using needles and guide structures. It is particularly desirable to provide simplified deployment systems and assemblies with fewer components, and even more desirable to provide components that are clearly visible to the user and are configured to be used and manipulated in a direct, intuitive manner. At least some of these goals will be met by the following various embodiments.

[0010] SUMMARY OF THE DISCLOSURE

[0011] Introducing elements, intravascular access devices, and methods of using the same are described herein.

[0012] Generally, a guide element for an intravascular access device can include: 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 being configured to receive one or more tools therethrough; and a guide element within the working space, wherein a portion of the catheter body adjacent to the guide element is displaced in response to distal movement of the guide element along the needle within the working space.

[0013] This example and other examples described herein may also include any of the following. This part of the catheter body can be displaced by moving a flap (flap) formed on the catheter body in response to a guide element. This part of the catheter body can be displaced by a guide element, with a hardness different from the rest of the catheter body. This part of the catheter body with different hardness that can be displaced by the movement of the guide element can be an annular portion at the distal most part of the catheter body. This part of the catheter body with different hardness that can be displaced by the movement of the guide element can be adjacent to the working space or in a semicircular portion corresponding to the flat part of the needle. The catheter body can have a first part formed by a material of a first hardness and a second part formed by a material of a second hardness, wherein the first part can be adjacent to the working space, and the first hardness can be selected so that in use when the distal end of the guide element is advanced against the first part, the first part responsively deflects or deforms.

[0014] Typically, an introduction element for use with an intravascular access device may 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 may be configured to receive one or more tools therethrough, the introduction element may have a distal end and a proximal end separated by one or more annular elements, the introduction element may be configured to be advanced distally from the intravascular access device within a blood vessel, wherein the one or more annular elements may be configured to control at least the distal end of the introduction element.

[0015] In some examples, the intravascular guide element may also have at least two annular elements, wherein the first annular element may be configured to control the direction of travel of the distal end of the guide element. The distal end of the guide element may be an atraumatic end. The distal end of the guide element may be a shaped distal end. The guide element may be composed of multiple segments. The intravascular guide element may also include at least four annular elements. The needle may have at least one flat surface, and wherein the working space is defined by the inner arc of the inner surface of the catheter and the flat surface of the needle. The distal end may also include one or more deployment slits aligned with the working space. The distal end of the catheter may further include one or more conforming segments, wherein the distal end of the guide element may be configured to engage one or more conforming segments.

[0016] Typically, the intravascular access device may include a handle having a proximal end and a distal end, a slot extending from the proximal end to the distal end. The catheter may have a proximal catheter hub and a distal catheter lumen, and the proximal catheter hub may be releasably engaged to the distal end of the handle. An access needle extends proximally from within a needle holder through the catheter lumen, the access needle having at least one flat surface extending longitudinally along the periphery of the access needle and a tissue penetrating tip extending distally beyond the catheter lumen. A working space may also be included within the catheter along the length of the access needle, at least one flat surface, convex surface, or concave surface, or wherein the working space is configured to facilitate one or more tools to pass distally through the working space from the proximal end of the intravascular access device into the blood vessel. A slider may extend through the slot, and the slider may be in communication with the proximal end of the guide element, such that distal advancement of the slider causes a distal end portion of the guide element to be distally advanced from a position within the guide element incision along at least one flat surface of the access needle.

[0017] 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 includes a guide element. A working space can be defined by the needle flat surface and the inner surface of the catheter, wherein the working space is selectively accessible from the proximal end of the intravascular access device. The working space can be configured to be selectively opened at the distal end of the catheter, and wherein the working space is configured to guide a tool or tool segment to slide therethrough. The intravascular access device can also include an access needle lumen, wherein the guide element can include a plurality of annular elements between the distal end and the proximal end, wherein one or more of the annular elements can extend through the access needle lumen. The intravascular access device can also include a hemostatic valve having a longitudinal channel surrounding the periphery of the body balancing valve, wherein the hemostatic valve can be disposed within the proximal catheter hub. The access needle includes a plurality of flat surfaces, wherein each of the plurality of flat surfaces can be associated with a separate working space within the catheter lumen.

[0018] In some examples, the intravascular access device can further include an actuation button coupled to the needle holder, and an actuation element that applies a force on the needle holder toward the proximal end of the handle, wherein when the actuation button is pressed, the actuation element displaces the needle holder and the access needle toward the proximal end of the handle. The access needle retracts proximally toward the handle, and wherein the guide element can be configured to remain in a distally advanced position. The intravenous access device can further include a spool of the guide element connected to the proximal end of the intravascular device, wherein a certain length of the guide element can be contained within the spool. The guide element can be made of a metallic material, a polymer material, or a combination thereof in whole or in part. The guide element can include a plurality of segments, wherein one or more of the plurality of segments can include different materials.

[0019] All methods and apparatus described herein are contemplated herein in any combination and can be used to achieve the benefits described herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] A better understanding of the features and advantages of the methods and apparatus described herein will be obtained by referring to the following detailed description, which sets forth illustrative embodiments, and the accompanying drawings, in which:

[0022] Figure 1 is an illustration of an example of a guidewire element for use with an intravascular access device as described herein.

[0023] Figure 2 Illustrated is a distal end of an atraumatic guidewire element for use with an intravascular access device according to examples described herein.

[0024] Figure 3A and Figure 3B Illustrated are details of the arrangement of a guidewire element associated with an intravascular access device according to examples described herein.

[0025] Figure 4 An example of deployment of an introducer element advanced outwardly from an intravascular access device according to examples described herein is shown.

[0026] Figure 5A and Figure 5B is an illustration of an example of a distal detail of an introducing element as described herein.

[0027] Fig. 6A , Figure 6B and Figure 6C is a cross-sectional view of an example of an intravascular access device and a transition from a retracted configuration to a deployed configuration according to examples described herein.

[0028] Fig. 7A and Figure 7BA truncated, cross-sectional view of an intravascular access device according to examples described herein is shown illustrating transition of an introducing element from a retracted position to a deployed position.

[0029] FIG. 8A to FIG. 8F Illustrative examples of introducing element configurations along the length of the introducing element including the distal end are shown according to examples described herein.

[0030] 9A to 9D are illustrations of multifilament guiding elements including different configurations according to examples described herein.

[0031] Fig. 10A and Fig. 10B Illustrated is a distal configuration of an intravascular access device according to examples described herein.

[0032] FIG. 11A to FIG. 11C Illustrated are examples of distal configurations of intravascular access devices according to examples described herein.

[0033] Fig. 12A and Fig. 12B Illustrated are examples of distal configurations of intravascular access devices according to examples described herein.

[0034] Fig.13A and Fig. 13B is a cross-sectional view illustrating an example of a distal configuration of an intravascular access device according to examples described herein.

[0035] FIG. 14A to FIG. 14C is a cross-sectional view illustrating an example of an introducer element elongate body configuration as described herein.

[0036] FIG. 15A to FIG. 15C An example of a distal portion of a catheter having details of the distal tip of an introducing element as described herein is illustrated.

[0037] Fig.16 An example of an introducer element for use with an intravascular access device is shown.

[0038] Detailed Description

[0039] The intravascular access device may include a needle at least partially disposed within the catheter. The needle may be configured to pierce and pass through one or more tissue layers until access to the blood vessel is achieved. As the needle is advanced accordingly, the catheter may be advanced through one or more tissue layers. Once inside the blood vessel, it may be desirable for the catheter to be advanced beyond the needle into the blood vessel. A guide element, typically positioned between the outer surface of the needle and the inner surface of the catheter, may be selectively manipulated (e.g., advanced) before the distal end of the catheter to help guide and place the catheter in a position in the blood vessel away from the insertion point. The guide element may have one or more features that provide enhanced functionality, control, and safety.

[0040] As described herein, an intravascular access device can include a working space or working channel created by a needle having a semicircular cross-sectional geometry. Current intravascular access devices provide concentric circular cross-sectional geometries between a needle and a catheter (e.g., a tubular needle within a tubular catheter). The intravascular access device described herein provides a needle having a semicircular cross-sectional geometry. For example, the needle has a circumference comprising an arcuate and substantially flat segments. In some examples, the arcuate 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 removed segment). In some examples, the flat segment on the periphery of the needle can involve a minor segment missing from an otherwise complete circumference.

[0041] The dimension of the working space can be the area of ​​the missing minor segment of the needle. For example, considering the cross-section of the needle and the catheter at any point along their length, the area of ​​the working space can be calculated as the difference between the area of ​​the needle and the area of ​​the circular cross-section of the catheter. For example, at any cross-section of the catheter, the area can be calculated as πr 2 , r is the radius of the circular cross-section of the catheter; and the area of ​​the needle can be calculated as πr 2 -The area of ​​the missing minor segment. Thus, the working space can be the difference between the area inside the catheter and the area of ​​the needle.

[0042] The working space can 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 interior surface of the catheter can be configured to accommodate a guide element, as described herein. In some examples, the working space can be configured to accommodate procedure-related tools. For example, a tool can selectively enter and / or pass through the working space from the proximal end of the intravascular access device to the distal end or distal tip of the intravascular access device (e.g., the distal tip of the catheter).

[0043] The working space can be configured to accommodate the administration of one or more therapeutic agents during an intravascular access procedure. For example, the distal end of the needle can first penetrate and pass through biological tissue until entering a blood vessel. The catheter of the intravascular access device can be passed through the biological tissue with the needle until the distal end of the catheter is within the blood vessel. Then, the operator can introduce a tool from the proximal end of the intravascular access device accessible 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 it is functionally deployed within the blood vessel, as allowed by the positioning of the distal end of the catheter. The operator can 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 can retract the tool through the working space, thereby allowing the intravascular access device to remain in the appropriate position within the blood vessel.

[0044] According to any of the examples described herein, it may be useful to guide an intravascular access device into and / or through the vascular system of a patient. For example, the intravascular access device may first penetrate and pass through biological tissue until entering a blood vessel. The catheter of the intravascular access device may need to be advanced beyond an initial placement position into the blood vessel facilitated by the distal end of the needle. Therefore, a guide element may be deployed prior to catheter deployment to assist in path guidance and positioning of the catheter through a distal region of the vascular system. A guide element as described herein may include a distal end and a proximal end separated by a length of a guide element body that is configured to pass through an intravascular access device having a working space between the needle and the interior of the catheter.

[0045] Figure 1 An example of an intravascular access device 100 as described herein is illustrated, which has been inserted into a patient's blood vessel 101. An example of an introducer element feature is illustrated, wherein the distal end of the introducer element 105 is curled and forms an atraumatic distal end. As described herein, an advantage of the atraumatic end or distal end of the introducer element is to prevent accidental perforation of the blood vessel by the introducer element or other adverse events, such as snagging of the introducer element distal end by the patient's vascular anatomy. When the needle 115 has been inserted into the blood vessel 101, the introducer element distal end 105 can be advanced into the blood vessel and can be curled according to the shape memory of the introducer element material (e.g., nitinol).

[0046] In some examples, an introducing element as described herein may have a distal end configured to engage the interior of a blood vessel. For example, the distal end may include a distal tip (e.g., a distal terminal end) and a segment of the introducing element body. Figure 1As shown, the curled atraumatic distal end of the introducing element can be configured to be advanced through a blood vessel and maintain a geometric shape as it is advanced through the blood vessel. In some examples, the distal end of the introducing element can apply force against the interior of the blood vessel to open or otherwise facilitate passage of the catheter through a collapsed or partially collapsed blood vessel.

[0047] Figure 2 An example of a guide element 105 as described herein is shown. Figure 1 , the distal end 110 of the introducing element is curled to form an atraumatic tip. In some examples, in the retracted or ready configuration, the introducing element is generally linear at the distal end, and the introducing element can automatically conform to the atraumatic distal end as the introducing element 105 is advanced distally from the intravascular access device 100. Figure 2 , the introducing element is shown as being advanced from within needle 115. Needle 115 can have a hole extending through needle 115 from needle distal end 116 to the needle proximal end (not shown). The introducing element can be configured to pass or be advanced through the needle hole into the patient's vascular system.

[0048] The distal end of the introducing element may be flexible at one or more sections including the distal end and / or one or more sections of the introducing element body. Figure 2 The illustration shows that the introducing element has been advanced beyond the needle distal tip and, after contacting the inner surface of the blood vessel, the introducing element continues into the blood vessel by bending against the inner surface of the blood vessel with the help of the curved distal end.

[0049] In some examples, the guide element can be initially positioned in the intravascular device such that the guide element slides through the needle hole and distally further into the vessel beyond the needle tip. In this configuration, the needle can be retracted toward the proximal end of the intravascular access device to allow the guide element to remain in place, or can be advanced into the vascular system without the needle being held. This configuration can reduce the amount of traumatic impact to the vessel because the needle can be completely removed from the vessel and / or from the patient's anatomy, while the guide element remains effectively guiding the catheter as the guide element is advanced into the vessel along the guide element path.

[0050] The guide element can initially be disposed in one or more retracted or ready configurations throughout the intravascular access device. In some examples, the guide element can be substantially linear from the distal end to the proximal end and can be configured to slide through the intravascular access device through the working space between the outer surface of the needle and the inner surface of the catheter. In some examples, the guide element can be configured to slide through the intravascular access device via the needle hole. In some examples, the guide element can be configured to be advanced distally through the needle hole from the distal end of the intravascular access device while wrapping proximally through the working space of the intravascular access device, as described herein. In some examples, the guide element can wrap around into the same area or space from which it was advanced. For example, in Figure 3A , an introducer element distal loop 120 is illustrated with the introducer element 106 being advanced from within a needle hole. A dashed line is included to illustrate an example of the distal end folding back through the needle hole toward the proximal end of the intravascular access device. In some examples, the introducer element can be a single length of one or more materials and can be advanced into a vessel through an intravascular access device guided by the introducer element at a point between the distal and proximal ends. In some examples, the introducer element can include a loop of material that can be advanced through an intravascular access device. Figure 3A In the example shown, the guide element 106 can have a first side 106a and a second side 106b of an elongated body. Thus, the side 106a or 106b can be advanced to provide the ring 120 to be advanced in the blood vessel. For example, when one or both sides of the guide element 106 are advanced distally, the ring 120 can roll outwardly toward the distal side. Figure 3B is a close-up view of the distal end of the intravascular access device, illustrating an example of an introducer element 106. The proximal or distal ends of the introducer element are not shown. However, it can be seen that the introducer element is at least partially positioned within the needle hole and partially positioned within the working space of the intravascular access device 100. In this configuration, the introducer element can be selectively advanced so that the operator can advance the introducer element distally from the intravascular access device through the needle hole, or through the working space, or some combination of the two. For example, the intravascular access device can be positioned within a vessel, and the operator can first attempt to advance the introducer element distally through the working space, then can advance the introducer element through the needle hole to guide the introduction of the introducer element through the vascular system, and then the operator can simultaneously advance both the working space side of the introducer element and the needle hole side of the introducer element. In some examples, advancing both sides (e.g., both ends) of the introducer element distally can create a loop or can adjust the size of the loop created when the introducer element is advanced distally from the intravascular access device. For example, if both sides of the introducing element are advanced, the size of the ring may increase because the introducing element body at the ring may bias the introducing element to an open position, thereby increasing the size of the ring.

[0051] As mentioned above, Figure 4The transition from the retracted position to the advanced position is illustrated, wherein the first side 126 of the introducing element 106 is advanced, showing the advancing element passing through the working space 130 while the needle 115 remains stationary. Notably, the working space 130 is visible, and the intravascular access device 100 is oriented to show the needle flat surface 135 extending partially outward from the catheter distal end 140. It can be appreciated that the flat surface of the needle serves as a platform for the portion of the introducing element 106 that is located within the working space 130. Although not explicitly shown, the interior of the catheter can be a continuous rounded interior surface to form the working space 130 with the flat needle surface 135.

[0052] Figure 5A and Figure 5B An example of a guide element having a shaped distal tip 145 as described herein is illustrated. The guide element distal tip can be defined by a portion of the guide element (e.g., the distal end or distal end segment) or by a shaped distal end. The shaped distal ends of the guide elements described herein can include distal ends that are welded or otherwise attached to the distal tip of the guide element. Figure 5A In the embodiment, the shaped distal end 145 can be molded with the guide element during initial manufacturing, or can be attached to the guide element at a later time. In some examples, the shaped distal end can be a modified distal tip, such that the distal tip of the guide element is modified to a certain shape or configuration. Figure 5A The example shown in FIG. 1 has a shaped distal tip 145 that essentially completes the needle distal end geometry into a cylindrical or tubular shape that tapers from near the distal end of the needle (e.g., near the end of the needle) to the distal end of the catheter 143. In this configuration, the impact of the distal end of the intravascular access device is reduced as it penetrates and passes through the biological tissue and blood vessels of the patient's anatomy, thereby reducing the penetration force. Figure 5B As shown, a similarly shaped distal tip 145 of the guide element 150 protrudes from the distal end of the guide element 150 having more than one annular element 155 (eg, body segment) extending proximally therefrom. Figure 5BA guide element having two annular elements 155 including a guide element body is illustrated. As described herein, a guide element having a body consisting of a plurality of annular elements increases the functionality of the guide element. For example, when the guide element 150 is advanced distally into the vascular system, the two annular elements 155 can be advanced simultaneously and can maintain substantially parallel guide element paths relative to each other. In some examples, less than all of the annular elements 155 can be advanced to facilitate selective directional control of the guide element 150 (e.g., the distal end of the guide element). For example, if the operator advances two annular elements at the same time, the guide element can be advanced distally into the vascular system. If the operator advances less than all of the annular elements 155 at a time, the distal end of the guide element can turn or bend in one direction. In some examples, the guide element 150 can turn or bend in the direction opposite to the advancing annular element. In some examples, the operator can selectively retract less than all of the guidewire annular elements to steer or turn the distal end of the guide element when the guide element is advanced through the vascular system. In some examples, the distal segment of the introducing element is molded, welded, formed, or configured for a specific function.

[0053] Guiding element as described herein may include one or more sections, segments, parts or regions with different materials and / or material properties.For example, guiding element as described herein may include an elongated member extending from the proximal end to the distal end or distal region, and the compliant end may be coupled to the distal end of the elongated member at the distal end or distal region.For example, guiding element as described herein may have a wire (e.g., elongated / annular member) extending from the proximal end to the distal end, and plastic, polymer and / or other acceptable molding materials may be coupled to the wire at the distal end.In some examples, the distal region may be molded, welded, adhered or otherwise attached to the distal end or distal region of the guiding element body.In some examples, the compliant end (e.g., distal region / distal end) of guiding element may be manufactured on the elongated member body of guiding element.In some examples, the elongated member body of guiding element may have one or more features (e.g., tabs, pointed tips, grooves, handles, etc.), and the one or more features may be configured to keep the compliant end coupled thereto. In some examples, the elongated body of the introducing element can be a wire or similar element having appropriate column strength to advance or otherwise control the introducing element during use (eg, into or through the vascular system).

[0054] Figure 5BAlso shown are examples of increased functionality of guide elements as described herein. Each of the annular elements 155 is arched or bent away from each other in a spring-biased manner, forming a bubble or opening that can expand as the guide element is advanced further outward from the intravascular access device. Expanding these annular elements in this manner can increase or otherwise enlarge the vascular opening to facilitate the patient and / or operator during the procedure. In some examples, the shaped distal tip 145 can refer to a nose core or core segment that includes the distal end of each annular element 155 within or attached to the nose or distal end of the guide element 150.

[0055] As described herein, an introducing element may include an atraumatic tip. Fig. 6A and Figure 6B An example of a circular or annular tip 127 of a guide element 123 is illustrated, which is formed at a distal end or distal segment so that the tip can be configured to protect the guide element during blood vessel insertion by making the catheter tip flexible and allowing the element to emerge from the distal end of the catheter after blood vessel insertion. The catheter 112 is shown as being substantially transparent to highlight the position of the guide element in the working space. Thus, the annular element 155 of the guide element 123 is configured to be slidably advanced or retracted through the working space 130 between the flat surface of the needle and the interior of the catheter. Fig. 6A An example of an introducer element in an extended or advanced configuration beyond the distal end of the intravascular access device 100 is illustrated. Figure 6B The guide element 123 is illustrated in a retracted configuration such that the entire distal end of the guide element is retracted and positioned within the catheter 112. In addition, the distal end of the catheter 112 is shown contacting the outer surface of the needle, including contacting the outer needle flat surface, which can be seen extending beyond the distal end of the catheter 112. Figure 6C An exploded view of a cross section of the needle 115 and the annular element 155 of the guide element 123 without a catheter is added in FIG. In particular, the needle flat surface extends across a segment of the needle periphery while being provided with a needle hole 157.

[0056] In some embodiments, the guide element can be maintained in a ready configuration or position within the distal end of the intravascular passage. For example, before, during, and / or after the intravascular access device is inserted into the patient's vascular system, the guide element can continue to remain in a ready configuration within the interior of the catheter. In this configuration, the needle can slide distally and / or proximally without disrupting the position of the guide element. Similarly, the catheter can also be advanced or retracted along the needle with the guide element continuously maintained in the ready configuration. For example, as described herein, the guide element can be maintained in the working space while the needle is initially advanced or extended distally in preparation for tissue penetration, and the guide element can be maintained in the working space by the distal end of the tapered catheter.

[0057] The guide element structure can be constructed or have a geometry that adapts to the working space, the flat surface of the needle, the inner surface of the catheter, the needle hole, the distal end of the needle, the distal end of the needle, the program parameters, the guide element function, the maneuverability of the guide element, etc. For example, the guide element can be geometrically configured to conform to the outside of the needle, and the outside of the needle can be curved so that the guide element cross-sectional geometry is concave to adapt to the curved outside of the needle. In other examples, the flat surface of the needle can be adapted by one or more of the guide element annular elements having corresponding flat surfaces. In some examples, the geometry of each of the annular elements can complement each other so that the annular elements maximize the volume occupied by the guide element in the intravascular access device. In some examples, the geometry of the annular elements can complement each other so that they promote the optimized maneuverability or function of the guide element. In some examples, the guide element can have two or more annular elements, which can be roughly cylindrical (e.g., circular cross-section). In some examples, the size of the guide element and / or each annular element can take into account the function or deployment route of the intravascular access device. For example, the ring elements may have a diameter between 0.0055" and 0.0075". In some examples, each ring element may have a width between 0.0060" and 0.0070". In some examples, the width of the ring element may be 0.0065". In some examples, the width of the ring element may be relative to the width of one or more other ring elements of the same guide element.In some examples, the width of the annular element may be 0.00075", 0.001", 0.00125", 0.0015", 0.00175", 0.002", 0.00225", 0.0025", 0.00275", 0.003", 0.00325", 0.0035", 0.00375", 0.004", 0.00425", 0.0045", 0.00475", 0.005", 0.00525", 0.0055", 0.00575", 0.006", 0.00625", 0.0065", 0.006 75”、0.007”、0.00725”、0.0075”、0.00775”、0.008”、0.00825”、0.0085”、0.00875”、0.009”、0.00925”、0.0095”、0.00975”、0.01”、0.01025”、0.0105”、0.01075”、0.011”、0.01125”、0.0115”、0.01175”、0.012”、0.01225”、0.0125”、0.01275”、0.013”、0.01325”、0.01 35”、0.01375”、0.014”、0.01425”、0.0145”、0.01475”、0.015”、0.01525”、0.0155”、0.01575”、0.016”、0.01625”、0.0165”、0.01675”、0.017”、0.01725”、0.0175”、0.01775”、0.018”、0.01825”、0.0185”、0.01875”、0.019”、0.01925”、0.0195”、0.01975”、0.02”、0.02 0.025", 0.0205", 0.02075", 0.021", 0.02125", 0.0215", 0.02175", 0.022", 0.02225", 0.0225", 0.02275", 0.023", 0.02325", 0.0235", 0.02375", 0.024", 0.02425", 0.0245", 0.02475", 0.025", 0.02525", or more. In some examples, each ring element can have a different width. In some examples, more than one ring element can have the same width.

[0058] In some examples, the annular elements may be in contact with or substantially adjacent to each other. For example, the annular elements may be substantially parallel to each other along a segment of the guide element. In some examples, the annular elements may be separated from each other by a gap (e.g., two annular elements may be separated by a gap of 0.004"). In some examples, the guide element may have a combined cross-sectional width (e.g., two annular elements, the gap between them may be 0.017").

[0059] The introducing element may be used with an intravascular access device having a catheter 160 having a catheter distal end door 165 configured to facilitate transitioning the introducing element 105 from a ready configuration to an advanced configuration or an in-use configuration. Fig. 7A and Figure 7B An example of a longitudinal cross-sectional view illustrating the distal end of an intravascular access device 100 (e.g., a catheter of an intravascular access device) and an introducing element having a curled distal end 108 curled over a needle distal tip is shown. The introducing element extends outwardly from a working space 130 between a catheter 160 and an outer surface of the needle. A needle flat surface 135 extends along the needle body to the needle distal tip, and a catheter distal tip 165 configured to accommodate distal transition of the introducing element from within the working space into a blood vessel is shown in an open position biased open by an advancing introducing element ring 108 therethrough.

[0060] In some examples, the distal end, distal portion, distal segment, etc. of the catheter can be configured to expand or have increased elasticity or flexibility to allow the guiding element to extend distally from the catheter interior to the interior of the blood vessel. For example, the area adjacent to the distal end of the catheter can include a material having a hardness grade less than the proximal portion or proximal segment of the catheter. In this way, the catheter can include a distal opening that is configured to contact the outer surface of the needle when the catheter is initially inserted into the blood vessel. Then, after the catheter has been inserted, the guiding element can be advanced distally from the inside of the working space, and the distal periphery of the catheter can expand or bend, thereby allowing the guiding element to pass through the distal periphery of the catheter and enter the blood vessel. In some examples, the distal periphery of the catheter can be configured to shrink around the outer surface of the needle. In some examples, the distal periphery of the catheter can be configured to shrink around the outer surface of the needle and the outer surface of the guiding element when the guiding element is advanced into the blood vessel. Figure 7B 108, wherein the guide element has been extended to a length 109 beyond the needle tip, thereby maintaining a curled distal end 108. The catheter distal door is a slit or other opening to allow the guide element to pass therethrough while maintaining a maximum amount of continuous contact around the needle periphery. From these cross-sectional views, the guide element can extend through a slit in the distal end of the catheter, through an elastic periphery of the distal end of the catheter, or a combination thereof.

[0061] 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 catheter described herein may include an area (e.g., segment, part, zone, feature, etc.) that has increased flexibility relative to other segments, parts, zones, zones, features, etc. For example, the hardness grade of the catheter or catheter area can be measured according to Shore 00, Shore A or Shore D scales. In some examples, according to Shore 00, Shore A or Shore D scales, the hardness grade of the catheter or catheter area can be 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100 or higher or any value therebetween. For example, compared with the distal end, distal periphery, deployment slit, etc. or a combination thereof, the elongated body of the catheter may include a higher hardness grade. For example, the elongated body of the catheter may be Shore A 40, and the distal area of ​​the catheter (e.g., distal periphery) may be Shore A 20.

[0062] In some examples, the catheter can include one or more materials such as silicone rubber, nylon, polyurethane, polyethylene terephthalate (PET), latex, polyimide, thermoplastic elastomer, etc. Any catheter described herein can include a region (e.g., segment, portion, area, feature, etc.) having increased elasticity relative to other segments, portions, regions, zones, features, etc. For example, a distal end, distal region, or distal periphery of a catheter can have increased elasticity that is configured to enlarge a distal opening and allow a guide element to be advanced distally from a working space.

[0063] In some examples, the guiding element may have shape memory in one or more of the annular elements. FIG. 8A to FIG. 8E Examples of shape memory of one or more of the annular elements of the guide element are illustrated. The shape of the guide element along a segment of its body or near the distal end can provide benefits to the function and operation of the guide element during the procedure. In some examples, the guide element can initially maintain a linear or substantially linear shape in a ready or retracted configuration. When the guide element is advanced distally from the intravascular access device, the shape memory can exist in any predetermined configuration and be imparted to the guide element and / or guide element components.

[0064] refer to Fig. 8A, and in some examples, the guide elements described herein may include an atraumatic tip at the distal end of an elongated body. Here, the elongated body includes two members 190a and 190b. In some examples, members 190a and 190b can be advanced simultaneously or at different rates relative to each other. In the event that they are advanced at different rates (e.g., member 190a is advanced faster than member 190b), the atraumatic tip 190 can be a different segment of the total length of the guide element so that the characteristics of the atraumatic tip are maintained over the length of the guide element that forms the atraumatic tip. Figure 8B In the example of the guide element, the loop 195 as the atraumatic distal end is included, wherein the segments of the guide element are curled after it has been advanced from the catheter. For example, the elongated body 200 can be coaxial with the distal end of the guide element when the elongated body 200 is stowed in the catheter, and then the distal segment 195 can be curled when the guide element is advanced beyond the needle tip. Figure 8C , examples of variations in the shape of the elongated body of the introducing element are shown. Here, the atraumatic tip 205 may be positioned at the distal end of the two nonlinear members 205a and 205b comprising the elongated body. Thus, in some examples, the introducing elements described herein may have features and properties that improve navigation through a blood vessel or provide additional support and functionality, such as dilating a blood vessel or resolving an obstruction when advanced into the vessel. Fig.8D Another example of an introducing element having a hook end 211 is shown, wherein the distal end 210 is not fully curled at the distal region of the introducing element. Fig. 8E As shown, the guide element can be considered based on different segments or regions of the guide element. For example, the proximal region 215 can include materials with different stiffness or composition to provide column support and strength when advancing the guide element. Region 215 can include a shape memory or material composition configured to facilitate changes in the form and function of the guide element. Finally, the distal end 217 can be configured to provide an atraumatic tip or other attributes or improved deployment and navigation. Fig.8F , which has a distal curl 196 at the end of the elongated body 201. Here, the curl can be a curl greater than 360 degrees. In some examples, the guide element can include a distal end having multiple curls at the distal end. Thus, the distal end can be configured to provide increased flexibility, such as a spring, when navigating tortuous blood vessels.

[0065] 9A to 9D Additional examples of guide elements as described herein are shown. Fig. 9AIn the example of the cross section of the guide element segment, a plurality of annular elements (e.g., 220 and 221) are arranged relative to each other in a generally linear manner, because they can be on top of the flat surface of the needle in the working space before, during, or after the distal advancement. Their cross-sectional geometry is generally circular, but can be any geometry that can help control and operate the guide element and / or the distal end or distal tip of the guide element during surgery. With multiple annular elements (e.g., multiple annular elements with the same or different characteristics), there can be additional capabilities to control and operate the guide element. For example, two central annular elements 221 can allow vertical control or manipulation of the guide element within a blood vessel, or can allow increased structural integrity when the guide element is advanced into the vascular system. The lateral annular element 220 can provide lateral control. For example, first advancing the guide element distally can be accomplished by advancing any one or all of the annular elements, and then the operator can turn the distal tip to one side or the other by retracting or advancing the lateral annular element 220. Fig. 9B Another variation of the guide element described herein having a molded or attached distal tip 515 is shown. Fig. 9B In the example shown, there are multiple ring elements 225a and 225b. However, the molded or attached distal tip on the guide element can be located at the distal end of a single elongated body (e.g., a ring element) or multiple ring elements (e.g., 225a and 225b). Fig. 9C and Fig.9D As shown, based on the manipulation of one or more ring elements, the guide element distal tips 204 and 246 may be able to make turns of up to 180 degrees. For example, one or more ring elements can actuate the transition from a linear guide element configuration to a curled atraumatic distal tip. Fig. 9C and Fig.9D In the invention, the guide element may be formed of a woven material. For example, Fig. 9C A length 230 of an elongated body 235 is illustrated, which can be a braided or woven structure. In some examples, the braided or woven structure of the guide element can be coated or covered (e.g., a biocompatible polymer, metal, etc.). In some examples, the guide elements described herein can have a curled or curved atraumatic distal tip that can be changed from a first position (e.g., a linear shape in a ready configuration) to a second position whereby the distal tip is curled, bent, looped, or otherwise changed from a linear 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.9DMultiple loops or curls are shown of the distal region 245 of the introducing element. In some examples, the distal end of the introducing element can be curled, looped, or otherwise in a non-linear configuration (eg, in a ready-to-use configuration) inside the intravascular access device before it has been advanced.

[0066] Fig. 10A An example of an introducer element and intravascular access device as described herein is shown. The distal end of the intravascular access device 100 is illustrated as a longitudinal cross-sectional view highlighting the retracted or ready configuration of the introducer element 105 within the working space 130 between the needle 115 (e.g., the needle flat surface) and the inner surface of the catheter 112. The working space can be at any position longitudinally along the length of the needle and catheter at the distal end of the intravascular access device relative to the arrangement and orientation of the needle flat surface. For example, Fig. 10A A needle 115 is illustrated having a distal tissue penetrating tip aligned at a position such that the guide element will be advanced distally along the longest length of the needle 115 until it has been advanced beyond the tissue penetrating tip. The flat surface may be at any position longitudinally along the needle body (e.g., radial or clockwise relative to the needle axis). In some examples, there may be more than one working space, whereby the needle of the intravascular access device may have more than one flat surface (e.g., a square or other polygonal geometry), thereby forming a working space with each flat surface and the inner surface of the catheter.

[0067] exist Fig. 10BIn the present invention, an intravascular access device as described herein is illustrated as having a catheter having a distal end including a deployment slit 250 (e.g., a catheter distal end door). The deployment slit 250 can be configured to facilitate the advancement or other operation of the guide element from the working space when the guide element is to be advanced distally from the intravascular access device. For example, the guide element can be advanced distally against the distal end of the catheter with sufficient force or pressure to open or separate the deployment slit 250, and then extend or be able to be advanced beyond the distal end of the catheter. In some examples, the distal slit of the catheter can be a single slit or multiple slits. In some examples, the arrangement of the deployment slit 250 can be associated with the position or arrangement of the intravascular access device working space. For example, the deployment slit 250 can be aligned with the distal terminal of the working space. In some examples, multiple deployment slits can be arranged relative to each other so that they form a wing or a catheter distal end door (e.g., as described above). In some examples, the distal end of the catheter is elastic and can outline 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 distal end of the catheter can expand against the elastic contraction force against the flat surface of the needle to create a seal around the advanced guide element and the needle, thereby preventing unwanted flow of fluid (e.g., blood) from within the vessel through the working space of the catheter.

[0068] In some examples, the deployment slits can be one or more perforation lines arranged around the distal end of the catheter to provide or facilitate a path for the distal end of the guide element to transition from the stowed configuration to the deployed configuration. In some examples, one or more deployment slits can indicate a line or area of ​​increased flexibility such that the catheter outer surface remains continuous, yet the deployment slits can be configured to expand to allow the guide element to transition from the stowed configuration to the deployed configuration.

[0069] Deploying the slit arrangement may include orienting the slit distally from the catheter. For example, Figures 11A-11C Deployment slits at various angles or arrangements at or near the distal end of the catheter are illustrated to facilitate manipulation of a guide element or another tool that is advanced through or out of an intravascular access device (e.g., a working space). In some examples, the deployment slits may also facilitate one or more annular elements of the guide element. For example, as Figure 4 As shown, where the guide element can extend within or through the needle hole 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 hole into or through the working space.

[0070] refer to Fig.11A, the deployment slit 251 is angled and configured to provide a minimized opening in the periphery of the distal end of the catheter. In some examples, when the guide element is advanced against the deployment slit 251, a passage, flap, door, etc. can be created. Similarly, in Fig. 11B In some embodiments, the deployment slit 252 is angled so that the distal end of the fin or opening is larger around the perimeter of the distal end of the catheter. In some examples, the geometry of the deployment region or zone of the distal end of the catheter can be configured to accommodate a tool or guide element distal end having a complementary geometry. For example, a guide element or tool that is advanced distally from within a catheter having a larger distal tip can benefit from a catheter such as Fig. 11B ), which has a larger opening or elastic area at the distal periphery of the catheter. Finally, Fig. 11C Yet another example of an introducer element deployment region on the distal side of catheter 113 is illustrated having parallel deployment slits 253 that provide an area or tab configured to facilitate distal advancement of the introducer element distal tip from within the catheter.

[0071] In some examples, any catheter described herein may include a continuous distal end, whereby a segment, region, periphery, or zone of the distal end of the catheter may be configured to allow a guide element to be advanced distally from within the catheter without disrupting the continuous outer surface of the catheter. For example, a flap or door provided by a deployment slit described herein may represent a zone of reduced structural integrity or increased elasticity that allows a guide element to be deployed from within the catheter while the distal end of the catheter remains in substantial contact with the outer surface of the needle and the guide element extending therethrough. For example, in any catheter described herein, the distal end may be configured to facilitate deployment of the guide element without disrupting the structure of the catheter itself.

[0072] In any example, the deployment region (e.g., a deployment slit, a door, a flap, an elastic region, an elastic perimeter, a distal region with a lower hardness level, etc.) can be configured to facilitate the introduction of tools or other interventional devices deployed from the interior of the catheter through the working space between the outer surface of the needle (e.g., the flat surface of the needle) and the inner surface of the catheter. For example, a cutting device, a suction device, an imaging device, a light, a balloon, etc. can be deployed from within the catheter.

[0073] Fig. 12A and Fig. 12B Examples of transitions for guide elements that include a deployment slit or a catheter distal door created by more than one deployment slit are illustrated. Fig. 12B Introducing element 200 is shown extending outwardly from deployment opening 256 with the curled end of the introducing element advanced forwardly and distally beyond needle 115. Fig. 12A , the guide element is in a stowed or ready-to-use configuration prior to deployment from within the catheter 113 and the working space therein. Fig. 12B, introducing element 200 has been advanced distally through opening 256 and continues beyond needle 115 .

[0074] Similarly, Fig.13A and Fig. 13B The longitudinal cross-sectional view of FIG. 1 illustrates an example of a flexible distal end 275 or segment of the catheter 271. Fig.13A In the embodiment of the present invention, the distal end of the catheter 276 contacts the outer surface of the needle 115, so that the guide element 123 remains in the working space and in the stowed configuration. Fig. 13B , introducing element 123 has been deployed against resilient perimeter 276 such that the catheter perimeter now contacts the outer surface of the needle and the outer surface of the introducing element extending therethrough.

[0075] In some examples, the distal end or region of the catheter has a deployment feature (e.g., a catheter door / deployment slit) to facilitate the transformation, advancement, or other functions of the intravascular device (e.g., a guide element). In some examples, the deployment feature is a deployment slit or slit configuration that can provide a door, flap, or otherwise selectively openable distal lumen of the catheter to allow the guide element and / or needle to extend therethrough. In some examples, the deployment feature can be an area of ​​the expandable (e.g., elastic or compressible) distal lumen of the catheter that can be biased around the outer periphery of the intravascular access device (e.g., a needle), which can seal or close the working space until the guide element is advanced through the deployment feature. For example, the guide element can be located within the working space and advanced against the compression of the distal lumen (e.g., deployment feature) of the catheter to fully expand the opening, thereby allowing the guide element to be advanced therefrom. In some examples, the distal lumen (e.g., deployment feature) of the catheter can conform to the outer periphery of the intravascular access device, the outer periphery of the intravascular access device including the periphery of the guide element extending therethrough.

[0076] In some examples, the distal end or distal tip of the catheter can have a conformable segment that conforms to the distal end of the guiding element. The guiding element has a shaped or connected distal tip that has a geometry that is complementary to the conformable segment of the distal end of the catheter. In this configuration, when the distal tip is located within the conformable distal segment of the catheter, the guiding element distal tip can be in a ready-to-use configuration. Fig.14A , Fig. 14B and Fig. 14C Additional illustrative examples of guide element ring element configurations are provided with consideration for needle 115. The number of ring elements, the arrangement of the ring elements, and the size of the ring elements may be based on or associated with the size of the working space (e.g., the length or surface of the needle flat surface and / or the volume of the working space formed by the needle flat surface and the interior of the catheter). For example, Fig.14A Two annular elements 280 are shown, and Fig. 14B A single annular element 281 is illustrated having an elliptical cross-sectional geometry, and Fig. 14C Yet another example of a plurality of annular elements 282 is illustrated. Fig. 14B Further details of examples of coupling or attachment of an introducer element to an introducer element distal tip are illustrated. Examples of introducers attached, coupled or otherwise engaged to a shaped distal tip are shown here. The distal tip of the introducer element can be formed into an atraumatic geometry to increase safety and improve maneuverability within a vessel.

[0077] exist FIG. 15A to FIG. 15C A further example of a guide element configuration is illustrated in FIG. Fig.15A , the distal segment of the guide element is shown having a molded or attached distal tip 290 at the distal end of an elongated body 292 comprising two annular elements. An engagement feature 291 is located on the proximal side of the distal tip 290 that is configured to seat within a corresponding feature or element of the distal tip of the catheter. Fig. 15B , the guide element distal tip 290 can be seen in a prepared position and seated in a corresponding feature or notch in the distal end of the catheter. Here, the guide element distal tip 290 is also shown as being in a configuration that provides a smooth transition at the distal end of the catheter. For example, the guide element distal tip 290 can be configured to seat in or otherwise engage the distal end of the catheter in a manner that completes the distal circumference or perimeter of the distal end of the catheter. In this way, when the catheter 196 is inserted into the blood vessel, there is a minimal amount of expansion required for insertion. Additionally, in Fig. 15B In the embodiment, the distal tip 290 of the introducing element is placed in the conformable section of the distal tip of the catheter, and then when the introducing element is advanced, the distal tip moves distally from the conformable section of the catheter tip beyond the needle. Fig. 15C , introducing element distal tip 290 has been advanced from catheter feature 295 and may be advanced into the vessel.

[0078] Fig.16An example of a guide element when deployed from within a working space by an intravascular access device 300 in use is illustrated. The intravascular access device 300 has a handle 305 and a slider 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. An enlarged view of the distal end of the catheter shows the catheter 123 in a stowed position within the working space outside the needle 115 and inside the catheter 315. In this example, the distal end 315a of the catheter can be an example of an area having increased elasticity, a reduced hardness level, or otherwise configured to shrink around the outside of the needle. That is, until the slider 310 is advanced, thereby advancing the guide element 123 distally along the outer surface of the needle 115 and passing through the distal end 315a of the catheter. As the slider 310 and the guide element 123 are advanced, the distal end of the guide element contacts the interior of the distal end 315 of the catheter to expand the distal end 315a of the catheter or is otherwise deployed from the catheter 315. In some examples, catheter distal end 315a may then maintain contact with introducing element 123 .

[0079] In some examples, the distal end of the guide element can be configured as a spring. For example, a bend or loop at the distal segment of the guide element can provide increased structural integrity compared to a partially looped distal segment, whereby the distal segment can be more compressible around the bend. In some examples, the bend or loop can provide a spring that can absorb forces or contact between the distal end of the guide element and the patient's anatomy.

[0080] 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, two, three, four...to a number of annular element segments sufficient to facilitate the optimized function and operation of the guide element and the associated intravascular access device. In some examples, the number of annular element segments can be related to the maneuverability of the guide element when it is advanced. For example, one or more of the annular element segments can be selectively displaced based on the desired progression or perception of obstacles within the vascular system.

[0081] In some examples, the distal end of the catheter can have a gap in a continuous circumference that is selectively opened by advancing an introducing element through the distal end of the catheter. The orientation of the gap or slit can be based on: the configuration of the distal geometry of the introducing element; the deployment function of the introducing element; the size of the introducing element; the vessel or vascular location where the intravascular access device is deployed; the distal tip of the introducing element; or more.

[0082] Some examples of materials comprising an introducer element or introducer element segments may include Nitinol, PEEK, or another material having sufficient hardness and stiffness to support advancement through the vascular system. Additionally, the material may have a memory property wherein a shape may be imparted to the material by molding or other forming means such that the shape is restrained in a retracted state and the shape is reestablished after the shaped portion is pushed out of the IV device / system.

[0083] In some examples, one or more of the guide element and / or guide element components may include one or more alloys. In some examples, the alloy composition of the guide element may be different at different zones of the segment along the length of the guide element or at each segment of the guide element. For example, the distal end may include one or more alloys that are configured to adapt, adjust or otherwise change the shape or orientation of the alloy segment. For example, the distal end may be a first alloy, the segment adjacent to the distal end may be a second alloy, and the segment adjacent to it may be a third alloy. The second alloy may have properties different from the first alloy and the third alloy, so that the second alloy segment changes, confirms or otherwise responds to different environmental factors, resulting in a predetermined or desired change in the configuration and orientation of the distal end of the guide element. In some examples, the alloy segment may shrink at a faster rate in the presence of a lower temperature than other alloys, thereby producing a predetermined bend or bend at the segment. In some examples, the guide element may have more than one annular segment, and each annular segment may include a different alloy and / or be composed of materials having different properties (such as stiffness, ductility, hardness, conductivity, etc.). For example, one annular element may include a material of sufficient stiffness to be advanced through an occlusion without causing bending or kinking in the guide element as it is advanced through the occlusion, while a second annular element may have less stiffness that may bend if the guide element is advanced using only the softer annular element. In such a configuration, the soft-sided annular element may act as a test element when advancing the guide element through the vascular system, and the soft-sided annular element may allow for testing of the amount of force required to advance the guide element through the occlusion.

[0084] The guide elements described herein (e.g., guidewires and related structures) can be used during a medical procedure (e.g., intravascular access) and / or in association with an intravascular access device. The intravascular access devices described herein (e.g., any elements of an intravascular access device) can be used in a medical procedure and / or in association with a medical procedure.

[0085] There may be one or more variations, alternatives, configurations, compositions and / or components described herein that may be used to modify elements, components, devices, systems, processes, etc. of an introducing element, intravascular access device, and / or related structures or processes. Therefore, any variations, descriptions, examples, elements, components, processes, methods, method steps, etc. described herein may be used as modifications, variations and / or substitutes for any elements, devices, systems, compositions, examples, components, processes, methods, method steps, etc. described in PCT application number PCT / US23 / 65556, filed on April 7, 2023, entitled “INTRAVASCULAR CATHETER WITH INTEGRATED GUIDE STRUCTURE”; and / or may be used as modifications, variations and / or substitutes for any elements, devices, systems, compositions, examples, components, processes, methods, method steps, etc. described in PCT application number PCT / US21 / 54046, filed on October 7, 2021, entitled “INTRAVASCULAR CATHETER WITH INTEGRATED GUIDE STRUCTURE”, the entire contents of which are incorporated herein.

[0086] It should be appreciated that all combinations of the foregoing concepts and additional concepts discussed in greater detail below (provided such concepts are not mutually inconsistent) are contemplated as being part of the inventive subject matter disclosed herein and can be used to achieve the benefits described herein.

[0087] When a feature or element is described as "on another feature or element" in this article, it can be directly on other features or elements, or there may also be intermediate features or elements. On the contrary, when a feature or element is described as "directly on another feature or element", there are no intermediate features or elements. It should also be understood that when a feature or element is described as "connected", "attached" or "coupled" to another feature or element, it can be directly connected, attached or coupled to other features or elements, or there may be intermediate features or elements. On the contrary, when a feature or element is described as "directly connected", "directly attached" or "directly coupled" to another feature or element, there are no intermediate features or elements. Although described or shown with respect to one embodiment, the features and elements described or shown in this way can be applied to other embodiments. It should also be understood by those skilled in the art that the reference to the structure or feature set "adjacent" another feature may have a portion overlapping or below an adjacent feature.

[0088] The terms used herein are only used for the purpose of describing specific embodiments and are not intended to limit the present invention. For example, unless the context clearly indicates otherwise, as used herein, the singular forms "a", "an", and "the" are intended to include the plural forms as well. It should also be understood that the terms "comprises" and / or "comprising" when used in this specification specify the presence of stated features, steps, operations, elements, and / or parts, but do not exclude the presence or addition of one or more other features, steps, operations, elements, parts, and / or groups thereof. As used herein, the term "and / or" includes any combination and all combinations of one or more of the relevant listed items, and may be abbreviated as " / ".

[0089] Spatially related terms, such as "under", "below", "lower", "over", "upper", etc., may be used herein for convenience of description to describe the relationship of one element or feature to another one or more elements or features as shown in the drawings. It should be understood that spatially related terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the drawings. For example, if the device in the drawings is reversed, elements described as "below other elements or features" or "beneath other elements or features" will be oriented to be "above other elements or features". Thus, the exemplary term "below" can cover both "above" and "below" orientations. The device can be oriented otherwise (rotated 90 degrees or in other orientations), and the spatially related descriptors used herein are interpreted accordingly. Similarly, the terms "upwardly", "downwardly", "vertical", "horizontal", etc. are used herein for illustrative purposes only, unless specifically stated otherwise.

[0090] 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 indicates otherwise. These terms may be used to distinguish one feature / element from another feature / element. Therefore, without departing from the teachings of the present invention, the first feature / element discussed below may be referred to as the second feature / element, and similarly, the second feature / element discussed below may be referred to as the first feature / element.

[0091] In this specification and the appended claims, unless the context requires otherwise, the term "comprise" and variations thereof such as "comprises" and "comprising" mean that various components can be used together in methods and articles (e.g., compositions and apparatus, including devices and methods). For example, the term "comprising" will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.

[0092] In general, any apparatus and method described herein should be understood to be inclusive, but all or a subset of components and / or steps may alternatively be exclusive and may be expressed as "consisting of various components, steps, sub-components or sub-steps" or alternatively "consisting essentially of various components, steps, sub-components or sub-steps."

[0093] As used herein in the specification and claims, including in the examples, and unless otherwise expressly stated, all numbers may be understood as beginning with the word "about" or "approximately", even if the term does not appear explicitly. The phrase "about" or "approximately" may be used when describing the amplitude and / or position to indicate that the value and / or position described are within the reasonable expected range of the value and / or position. For example, a numerical value may have a value of + / -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. Any numerical value given herein should also be understood to include about or approximate the value, unless the context otherwise indicates. For example, if the value "10" is disclosed, then "about 10" is also disclosed. Any numerical range listed herein is intended to include all subranges contained therein. It should also be understood that when a value is disclosed, "less than or equal to" the value, "greater than or equal to" the value, and possible ranges between values ​​are also disclosed, as appropriately understood by those skilled in the art. For example, if the value "X" is disclosed, then "less than or equal to X" and "greater than or equal to X" (e.g., where X is a numerical value) are also disclosed. It should also be understood that throughout the application, data is provided in a variety of different formats, and that the data represents endpoints and starting points and ranges for any combination of data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, it should be understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15, and between 10 and 15 are considered disclosed. It should also be understood that each unit between two specific units is also disclosed. For example, if 10 and 15 are disclosed, 11, 12, 13, and 14 are also disclosed.

[0094] Although various illustrative embodiments are described above, any of several changes may be made to the various embodiments without departing from the scope of the invention as described in the claims. For example, in alternative embodiments, the order in which the various described method steps are performed may generally be changed, and in other alternative embodiments, one or more method steps may be skipped altogether. Optional features of the various device and system embodiments may be included in some embodiments and not included in other embodiments. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be construed as limiting the scope of the invention as set forth in the claims.

[0095] The examples and descriptions included herein show specific embodiments in which the subject matter can be practiced by way of illustration and not limitation. As mentioned, other embodiments can be utilized and derived therefrom so that structural and logical replacements and changes can be made without departing from the scope of the present disclosure. For convenience only, such embodiments of the subject matter of the present invention may be referred to herein individually or collectively by the term "invention", and if in fact more than one is disclosed, it is not intended that the scope of the present application is actively limited to any single invention or inventive concept. Therefore, although specific embodiments have been illustrated and described herein, any arrangement that is considered to achieve the same purpose may replace the specific embodiments shown. The present disclosure is intended to cover any and all modifications or variations of various embodiments. After reading the above description, those skilled in the art will understand the combination of the above embodiments and other embodiments not specifically described herein.

Claims

1. An introducing 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 a lumen of a catheter 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; and A guide element is 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.

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

3. The guide element according to claim 2, wherein: The portion of the catheter body displaced by the guiding element has a different stiffness than the remainder of the catheter body.

4. The guide element according to claim 3, wherein: The portion of the catheter body having a different hardness that is displaceable by movement of the guiding element is an annular portion at a distal-most portion of the catheter body.

5. The guide element according to claim 3, wherein: The portion of the catheter body having different hardness that can be displaced by movement of the guiding element is adjacent to the working space or in a semicircular portion corresponding to the flat portion of the needle.

6. The guide element according to claim 1, wherein The catheter body has a first portion formed from a material of a first hardness and a second portion formed from a material of a second hardness, wherein the first portion is adjacent to the working space and the first hardness is selected so that in use, when the distal end of the guide element is advanced against the first portion, the first portion responsively deflects or deforms.

7. An introducing element for an intravascular access device, comprising: an intravascular access device having a needle within a lumen of a catheter 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; and An introducing element having a distal end and a proximal end separated by one or more annular elements, the introducing element being configured to be advanced distally from the intravascular access device within a blood vessel, wherein the one or more annular elements are configured to control at least the distal end of the introducing element.

8. The introducing element of claim 7, further comprising at least two annular elements, wherein a first annular element is configured to control a direction of travel of a distal end of the introducing element.

9. The guide element according to claim 7, wherein: The distal end of the introducing element is an atraumatic tip.

10. The guide element according to claim 7, wherein The distal end of the introducing element is a shaped distal tip.

11. The guide element according to claim 7, wherein: The guide element is composed of a plurality of segments.

12. The guide element of claim 7, further comprising at least one annular element.

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

14. The guide element according to claim 7, wherein: The distal tip of the catheter includes one or more deployment slots aligned with the working space.

15. The guide element according to claim 7, wherein The distal tip of the catheter includes one or more compliant segments, wherein the distal tip of the introducing element is configured to engage the one or more compliant segments.

16. An intravascular access device comprising: a handle having a proximal end and a distal end, a slot extending from the proximal end to the distal end; a catheter having a proximal catheter hub and a distal catheter lumen, the proximal catheter hub being 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 along a periphery of the access needle and a tissue penetrating tip extending distally beyond the catheter lumen; a working space within the catheter along the length of the access needle, the working space having a non-uniform circumferential cross-sectional geometry, wherein the working space is configured to facilitate passage of one or more tools distally through the working space into a blood vessel from a proximal end of the intravascular access device; and A slider extends through the slot, the slider communicating with the proximal end of the guide element such that distal advancement of the slider advances the distal tip portion of the guide element distally from a position within the guide element cutout along a surface of the access needle.

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

18. The intravascular access device of claim 16, wherein: The at least one tool comprises a guide element.

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

20. The intravascular access device of claim 16, wherein: The working space is configured to be selectively opened at the distal end of the catheter, and wherein the working space is configured to guide a tool or a tool segment sliding therethrough.

21. The intravascular access device of claim 16, further comprising an access needle lumen, wherein the introducing element can include a plurality of ring elements between a distal end and a proximal end, wherein one or more of the ring elements can extend through the access needle lumen.

22. The intravascular access device of claim 16, further comprising a hemostatic valve having a longitudinal passage around a perimeter of the intravascular balancing valve, wherein the hemostatic valve is disposed within the proximal catheter hub.

23. The intravascular access device of claim 16, wherein: The access needle includes a plurality of planar surfaces, wherein each of the plurality of planar surfaces is associated with a separate working space within the catheter lumen.

24. The intravascular access device of claim 16, further comprising an actuation button coupled to the needle holder, and an actuation element that applies a force on the needle holder toward the proximal end of the handle, wherein when the actuation button is depressed, the actuation element displaces the needle holder and the access needle toward the proximal end of the handle.

25. The intravascular access device of claim 16, wherein: The access needle is retracted proximally toward the handle, and wherein the introducing element is configured to remain in a distally advanced position.

26. The intravascular access device of claim 16, further comprising a spool of an introducing element in communication with the proximal end of the intravascular device, wherein a length of the introducing element is contained within the spool.

27. The intravascular access device of claim 16, wherein: The guide element is made completely or partially of a metallic material, a polymer material or a combination thereof.

28. The intravascular access device of claim 16, wherein: The guide element comprises a plurality of segments, wherein one or more of the plurality of segments comprises a different material.

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