Guiding element system for intravascular access - Patent Application 20070122997

Abstract

A guide element for 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 being 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 being configured to be advanced distally from the intravascular access device within a blood vessel, the one or more annular elements being 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 / 482,901, entitled "GUIDE ELEMENT SYSTEM FOR INTRAVASCULAR ACCESS," filed February 2, 2023, 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] In general, an intravascular access guide element for use in an intravascular access device may comprise an intravascular access device having a needle within a catheter lumen and a working space between the outer surface of the needle and the inner surface of the catheter; a guide element having a shaft on a proximal end and a tip at a distal end, a portion of the distal end having an outer shape adapted and configured to at least partially conform to the inner surface of the catheter and the outer surface of the needle, the guide element configured for distal and proximal movement along the working space and for advancement within and along the blood vessel and further distally from the intravascular access device, the tip on the distal-most end of the guide element having a rounded distal end and a preset curvature, such that as the guide element is advanced so that the tip exits the working space, the tip begins to transition to the preset curvature, and further, the shaft is one of wire, braid, or a combination of wire and braid.

[0008] This example and any other examples described herein may further include one or more of the following: The tip may further include an open interior portion on the proximal end, the size and shape of the proximal end portion adapted and configured to receive the distal-most end of the shaft. The shaft may be a wire having one or more deformations to increase the surface area of ​​the wire within the tip proximal end portion. The shaft may be a braid. The shaft may be a combination of wire and braid, and may be a wire and braid joined by one or more crimping zones. The tip on the distal-most end of the guide element may be an atraumatic tip. A section of the needle's circumference may be removed or formed into a flat, convex, or concave shape to create a working space inside the inner arc of the catheter inner surface and the needle surface, and a portion of the distal end of the guide element may at least partially conform to the inner arc. A portion of the needle section may be removed to create a combined working and blood flashback space within the inner arc of the catheter inner surface and the needle surface, or may be a contoured feature to create a combined working and blood flashback space.

[0009]

[0009] In general, an intravascular access device comprises a handle having proximal and distal ends and 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 surface extending longitudinally along a periphery of the access needle adapted to engage a portion of the guide element; and a tissue-piercing tip extending distally beyond the catheter lumen. the catheter may comprise an access needle having a guide element; a working space within the catheter along the length of at least one surface of the access needle, the working space configured to facilitate passage of the guide element therethrough distally from the proximal end of the intravascular access device into the blood vessel; and a slider extending through the slot and coupled to the proximal portion of the guide element of the first structure such that distal advancement of the slider advances a distal tip portion of a guide element of a second, different structure distally along the at least one surface of the access needle from a position contacting the guide element notch.

[0010] This example and any other examples described herein may further include one or more of the following: At least one surface of the access needle may extend longitudinally along an outer surface of the access needle. A working space may be defined by the needle surface and an inner surface of the catheter, and the working space may be 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, and the working space may be configured to guide a tool or tool segment sliding therethrough. The access needle may include a plurality of flat surfaces, each of the plurality of flat surfaces associated with a respective working space within the catheter lumen. The intravascular access device may further include an actuation button coupled to the needle holder and an actuation element that applies a force to 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. The access needle can be retracted proximally towards the handle, and the guide element is configured to remain in the distally advanced position.

[0011] The first or second structure of the guide element may be made entirely or partially of a metallic material, a polymeric material, or a combination thereof. The guide element may include multiple segments, one or more of which comprise different materials. The first or second structure of the guide element may be a wire, a braid, or a combination thereof, formed entirely or partially of a metallic material, a polymeric material, or a combination thereof. The access needle has at least one surface extending longitudinally along the circumference of the access needle, the at least one surface being a section of the needle's circumference that is removed or formed into a flat, convex, or concave shape to create a working space within the inner arc of the catheter inner surface, and further, at least a portion of the surface is adapted and configured to conform to the outer surface of the guide element distal end or guide element tip.

[0012] The intravascular access guide element may further comprise one or more radiopaque marker bands extending along the longitudinal axis of the catheter and interior to the sidewall of the catheter, each of the one or more radiopaque markers having a rectangular body and a beveled tip, the beveled tip being oriented toward the distal-most end of the catheter. Each radiopaque marker of the one or more radiopaque markers is evenly spaced from each of the one or more other radiopaque markers around the circumference of the catheter. The venous access device may further comprise one or more radiopaque marker bands extending along the longitudinal axis of the catheter and interior to the sidewall of the catheter, each of the one or more radiopaque markers having a rectangular body and a beveled tip, the beveled tip being oriented toward the distal-most end of the catheter. Each radiopaque marker of the one or more radiopaque markers may be evenly spaced from each of the one or more other radiopaque markers around the circumference of the catheter.

[0013]

[0013] The outer surface of the needle may be flat and a portion of the guide element tip distal end conforms to the flat portion of the needle, or the outer surface of the needle may have a groove and a portion of the guide element tip distal end conforms to the shape, curvature, or orientation of the groove. An access needle having at least one surface extending longitudinally along a periphery of the access needle adapted to engage with a portion of the guide element includes a flat portion and a portion of the guide element distal tip conforms to the flat portion of the needle, or at least one surface of the needle has a groove and a portion of the guide element tip distal end conforms to the shape, curvature, or orientation of the groove. The guide element may be molded onto the distal section of the shaft. The distal section of the shaft may be affixed to the interior of the guide element.

[0014]

[0014] Generally, 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 the blood vessel, and the one or more annular elements may be configured to control at least the distal end of the guide element.

[0015] 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 a modified flat, convex, or concave surface, and the working space is defined by the inner arc of the catheter inner surface and the modified surface of the needle. 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 conforming segments, and the distal tip of the guide element may be configured to engage with the one or more conforming segments.

[0016] 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 modified surface extending longitudinally along the circumference of the access needle, and the tissue-piercing tip may extend distally beyond the catheter lumen. Further included may be a working space within the catheter along the length of the at least one modified surface of the access needle, including a flat, convex, or concave type surface, 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 the modified surface of the access needle.

[0017] In some examples, the modified surface of the access needle extends longitudinally along the outer surface of the access needle. At least one tool comprises a guide element. A working space may be defined by the needle flat 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.

[0018] 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 sections and / or layers, where one or more of the multiple sections and / or layers can include different materials.

[0019]

[0019] All of the methods and devices described herein are contemplated herein in any combination and may be used to achieve the benefits described herein.

[0020] 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]

[0020] [Figure 1]

[0021] FIG. 1 is a perspective view from the distal end of an intravascular access device, including an example in which a guide wire is extended through a catheter along the outer surface of a needle, as described herein, with a guide element advanced beyond the distal tip of the needle. [Figure 2]

[0022] 2 shows a detailed perspective view of a distal portion of the intravascular access of FIG. 1 including an exemplary atraumatic tip formed by a guide element beyond the distal end of the needle. [Figure 3]

[0023] FIG. 10 is another perspective view of the distal end of the intravascular access device in a retracted or retracted configuration with the guide element seated within the notched tip of the intravascular catheter and the tissue-piercing tip exposed for use. [Figure 4]

[0024] A figure showing another example of a distal section of an intravascular access device, in which an example of a polymeric guide element distal tip is shown in a transparent manner so that the metallic nitinol wire section of the guide wire is positioned within the polymeric guide element distal tip. [Figure 5A]

[0025] FIG. 1 illustrates an example of an access needle as described herein, shown in perspective view with detailed views and cross-sectional features. [Figure 5B] FIG. 1 illustrates an example of an access needle as described herein, shown in perspective view with detailed views and cross-sectional features. [Figure 6]

[0026] Figures 6A, 6B, and 6C are detailed top views of a needle and guide element section showing different needle-guide element configurations as described herein. [Figure 7]

[0027] 1 is a cross-sectional view of a distal portion of a needle and a guide element in contact with each other inside a catheter. [Figure 8A]

[0028] FIG. 1 is a perspective view of an exemplary guide element from its proximal end, including an atraumatic distal tip and a guide element feature adapted for engagement with a guidewire. [Figure 8B] FIG. 1 is a perspective view of an exemplary guide element from its proximal end, including an atraumatic distal tip and a guide element feature adapted for engagement with a guidewire. [Figure 9A]

[0029] FIG. 10 shows a side view of the guidewire and guide element distal section in both the atraumatic and straight or retracted configurations, including a more detailed cross-sectional view of the guide element to expose the braided guide element interior. [Figure 9B] FIG. 10 shows a side view of the guidewire and guide element distal section in both the atraumatic and straight or retracted configurations, including a more detailed cross-sectional view of the guide element to expose the braided guide element interior. [Figure 9C] FIG. 10 shows a side view of the guidewire and guide element distal section in both the atraumatic and straight or retracted configurations, including a more detailed cross-sectional view of the guide element to expose the braided guide element interior. [Figure 10]

[0030] FIG. 10 is a perspective view of a guide element with a section removed from the view to expose another example of a braided interior comprising an annular element comprising various material properties as described herein. DETAILED DESCRIPTION OF THE INVENTION

[0021]

[0031] 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 placement of 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.

[0022]

[0032] The intravascular access devices described herein can include a working space or working 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. For example, the needle has a circumference comprising an arc and a generally flat, concave, or convex section. 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, concave, or convex surface of the needle defines a discontinuous circular circumference (e.g., a circle with a segment removed). In some instances, the discontinuous sections on the circumference of the needle may relate to small sections removed or formed from an otherwise complete circumference where the small sections have been removed or formed.

[0023]

[0033] The dimension of the working space can be the area of ​​the small section removed or formed by the needle. For example, considering a cross-section of the needle and 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 circular cross-sectional area of ​​the catheter. For example, at any cross-section of the catheter, the area can be calculated as itr2, where r is the radius of the catheter circular cross-section, and the area of ​​the needle can be calculated as itr2 - the area of ​​the small section removed or formed. Thus, the working space can be the difference between the area of ​​the inside of the catheter and the area of ​​the needle.

[0024]

[0034] 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).

[0025]

[0035] 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.

[0026]

[0036] 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.

[0027]

[0037] 1 illustrates an example of an intravascular access device 100 having a handle 150 and slider 155 adapted to control deployment of a guide element 105 through a lumen extending through a catheter 106 and along the outer surface of a needle positioned within the catheter lumen. An example of a guide element feature is shown, where the guide element 105 is generally curled and formed with an atraumatic distal end beyond the needle tip, so that the guide element may be within a patient's blood vessel when deployed. In some examples, an advantage of the atraumatic tip or distal end of the guide elements described herein is to prevent 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.

[0028]

[0038] The guide elements described herein may have a distal end 108 configured to engage the inside of a blood vessel. For example, the guide element distal end 108 may comprise a distal tip (e.g., 121, 122, etc.) and a section of a guide element body proximal to the tip. With reference to FIG. 1 , the guide element 105 may include a curled atraumatic distal end 108 configured to advance through a blood vessel and maintain a curled geometry when advanced through the blood vessel. In some examples, the distal end of the guide element may 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.

[0029]

[0039] 2 shows further details of the guide element 105 shown in FIG. 1 , with the curled guide element distal end 108 forming an atraumatic tip. In some examples, the guide element may be configured to transition from a generally straight configuration when in a stored or ready-to-use configuration and then automatically conform to the atraumatic distal end 108 as the guide element 105 is advanced distally from the intravascular access device 100. In FIG. 2 , the guide element is shown advancing from a needle 109. The needle 109 may have an aperture 110 extending therethrough from the needle distal tip to the proximal end of the needle (not shown). The guide element 105 may be configured to pass through or be advanced through the needle aperture to enter the patient's vasculature.

[0030]

[0040] In some examples, the guide element 105 may initially be provided in one or more retracted or ready configurations throughout the intravascular access device 100. When the guide element distal end 108 is advanced from the catheter 106 and out of a distal slit or notch 111 in the catheter distal end, it curls over the needle tissue-piercing tip 116 when deployed as shown in FIG. 2. The notch 111 in the catheter distal end may be configured to receive a portion of the guide element when the guide element 105 is in the retracted configuration to provide a seamless or smooth transition from the tissue-piercing tip to the catheter body.

[0031]

[0041] 2 further shows the distal end of the intravascular access device 100 and the distal end 108 of the guide element curled over the needle distal tip. The guide element extends outward from the working space between the inner surface of the catheter 106 and the outer surface of the needle. In this example, the needle flats extend along the needle body to the needle distal tip, and the catheter distal tip slit 111 is shown in an open position, biased open by the passage of the advanced guide element therethrough.

[0032]

[0042] In Figure 3, the guide element 105 is fully retracted into the working space 112 between the catheter and needle 109. In some examples, the guide element 105 may be generally straight from its distal end to its proximal end and may be configured to slide through the intravascular access device 100, passing through the working space 112 between the needle outer surface and the catheter inner surface. The guide element distal tip 121 is seated within the catheter distal end using a guide element docking feature 140 and seated in a catheter notch. The view of Figure 3 also includes several examples of location markers or radiopaque elements 145 within the catheter 106 configured to indicate the position of the catheter within a patient.

[0033]

[0043] In some examples, the devices described herein may be configured to access a blood vessel using a needle 109 that includes a retracted guide element 105 in a notch 111 at the distal end of the catheter. Once the blood vessel has been accessed, the guide element 105 may be deployed to assist in advancing and positioning the catheter within the blood vessel before the guide element and needle are retracted, leaving the catheter in place inside the patient.

[0034]

[0044] In FIG. 4 , guide element 105 may be attached to polymer filament or metallic wire 113 by overmolding or another method. In this example, polymer filament or metallic wire 113 is constructed or formed with features in distal section 114 to facilitate mechanical locking and permanent attachment of the guide element to the polymer filament or metallic wire. The metallic wire (e.g., guide wide) may include one or more features, such as 114, that include an irregular geometry compared to the length of the wire extending proximally therefrom. Engagement feature 114 may be molded onto the distal end of guide wire 113 and thus configured to aid in connection between guide wire 113 and guide element 105.

[0035]

[0045] 4, guide element 105 is shown in a substantially transparent format to allow exposure of an engagement feature 114 positioned within guide element 105 that is molded onto a distal end or portion of wire 113. An example of an engagement feature 114 is a flat spatula-shaped feature that will retrain the connection between guide element 105 and wire 113 to prevent guide element 105 from separating and dislodging the wire after being molded onto wire 113.

[0036]

[0046] 5A and 5B are detailed views of the distal end of an intravascular access device needle, illustrating examples of needle segments removed or formed along the circumference and cross-sectional area of ​​the needle described herein. Referring to FIG. 5A, the needle 109 is shown with a close-up detail highlighting the flat surface 109a along the outside of the needle. The flat surface can increase the volume of the interior space or working space of the catheter 106 when the needle is positioned therethrough. For example, the needle flat surface creates a circular section-shaped working space within the catheter between the inner catheter surface and the outer needle surface, allowing a guide element to pass therethrough. The tissue-piercing tip 116 is visible, with the needle lumen 118 opening through a beveled surface adjacent to the tissue-piercing tip 116. The proximal end of the needle is not shown.

[0037]

[0047] The needle configurations described herein may be adapted to selectively advance a guide element such that an 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. In this configuration, the needle lumen 118 remains patent, allowing blood flashback and visualization through the side vent 119 during intravascular access.

[0038]

[0048] In some examples, an alternative to a flat surface may be a shaped needle section with a groove 117 having a U-shaped or C-shaped cross-section, thus combining the working space and needle lumen 118a into one longitudinal open cross-sectional area.

[0039]

[0049] 6A through 6C further illustrate example needle cross-sectional geometries, including a top perspective view of guide element distal end 108, including guide element distal tips 121a, 121b, and 121c adjacent the needle outer surface. Focusing on the cross-section at the distal portion of the needle highlights example needle configurations (e.g., conforming surfaces). With reference to FIG. 6A, flat surface 119 is visible. While the contact surface of the guide element is not shown, FIG. 6A may further include a guide element with a conforming flat surface for contacting and sliding along needle flat surface 119. With reference to FIG. 6B, groove 117a is visible and can extend along the entire length of the needle or along a length less than the entire length of the needle. Groove 117a may have a width and depth that the guide element can conform to or substantially conform to. For example, guide element tip 121b may have a surface adapted to seat or conform to groove 117a. Referring to Figure 6C, a groove 117b is formed in the needle body. Similar to Figure 6B, the distal tip 121c shown in Figure 6C may have a conforming surface adjacent to the groove 117c to facilitate routing of the guide element and to increase the amount of working space inside the catheter for the guide element to operate or be stored within the catheter. Each of the examples shown in Figures 6A, 6B, and 6C includes a guide element docking feature 140 adapted to engage the catheter distal end (e.g., notch 111 not shown).

[0040]

[0050] In some examples, the guide element surface that contacts the needle outer surface may include a shaped distal tip 121. 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 shaped distal tip. The shaped distal ends of the guide elements described herein may include distal ends attached to the distal tip of the guide element. These shaped distal ends 121 may be molded with the guide element during initial manufacturing or may be affixed to the guide element at some later time. In some examples, the shaped distal end may be a modified distal tip, such that the distal tip of the guide element is modified into a certain shape or configuration.

[0041]

[0051] FIG. 7 provides a cross-section of a profile view from the distal end of the needle 116, the guide element's formed distal tip 122, and the interior radiopaque marker 145 of the catheter 106. In this example, the guide element contact surface 157 is shown formed and substantially conforming to the groove 117. For example, the guide element surface 157 effectively completes the geometry of the needle's distal end into a cylindrical or tubular shape by seating in the groove 117. Furthermore, the guide element distal tip 122 is shown tapering from near the distal end of the needle (e.g., near the needle tip) to the distal end of the catheter. This configuration results in reduced impact at the distal end of the intravascular access device as it moves through and penetrates the biological tissue and vessels of the patient's anatomy, thereby reducing penetration forces. In some examples, the distal section of the guide element is molded, welded, formed, or configured for a specific function.

[0042]

[0052] 8A and 8B are views of the guide element alone, without any other components of the intravascular access device. The molded guide element 105a may be manufactured first and then separately affixed to a polymer filament or metallic wire. Referring to FIG. 8A, openings 125 may be configured to accept adhesive or another coupling mechanism to affix the guide element 105a to a wire (not shown). For example, after the guide element 105a is formed, the wire may be introduced through the guide element 105a and then affixed using openings 125 and / or 123 in FIG. 8B. Each of these openings can be used to facilitate attachment of the polymer filament, metallic wire, or combination thereof to the guide element 105a, with the parts remaining interlocked after assembly via adhesive, welding, or any other specific assembly process.

[0043]

[0053] In some instances, the guide element may have a braided core or interior. Figures 9A, 9B, and 9C show a guide element 130 for an intravascular access device whereby the guide element is a composite of annular elements having different material properties.

[0044]

[0054] 9A and 9B, guide element 130 is shown in a curled configuration (e.g., deployed configuration) and a retracted configuration in FIG. 9B, in which the guide element is substantially straight. Guide element proximal end 131 may be relatively stiff to provide pushability. In FIG. 9C, guide element distal end 132 is soft and flexible for atraumatic insertion into the vasculature, and braided inner core 133 provides proximal end 131 with sufficient tensile strength for crimping within crimping zone 134. The braided inner core is positioned within outer sheath 135, which provides a smooth surface during insertion into the vasculature. In this example, the looped or curled distal end of the element may be formed using a pre-set method, molding, dip coating, welding, or any other specific assembly process.

[0045]

[0055] 10 shows an example of a guide element for an intravascular access device in an extended or advanced configuration, whereby the guide element 136 is a composite of annular elements with different material properties. In this example, the polymeric filament or metallic wire 137 is overbraided with polymeric or metallic filaments in a single or multi-layer pattern 138. The braided polymeric filament or metallic wire 137 is overmolded 139 to form the guide element 105. On the other hand, the braided section of the guide element provides the guide element with sufficient tensile strength, yet provides some stiffness for pushability. The braided polymeric filament or metallic wire 137 is positioned within an outer sheath 140, which provides a smooth surface during insertion into the vasculature.

[0046]

[0056] The guide element structure may be configured or have a geometry to complement the workspace, needle forming surface or needle flat 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 some examples, the 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 the function or deployment route through the intravascular access device. For example, the annular elements may have a diameter between 0.127 mm (0.005 inch) and 1.27 mm (0.050 inch). In some examples, each annular element may have a width between 0.127 mm (0.005 inch) and 1.27 mm (0.050 inch). 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, each annular element may have a different width. In some examples, two or more annular elements may have the same width.

[0047]

[0057] In some instances, the retracted guide element forms an atraumatic surface with the distal end of the intravascular catheter, thereby reducing the impact of the distal end of the intravascular access device as it moves through the tissue and vessels of the patient's anatomy, thereby reducing penetration forces. For example, and as shown in FIG. 7, the formed distal tip 122 effectively completes the geometry of the needle distal end, tapering from near the distal end of the needle (e.g., near the needle tip) to the distal end of the catheter into a cylindrical or tubular shape.

[0048]

[0058] 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.

[0049]

[0059] In some examples, the guide element and / or one or more of the components of the guide element may comprise one or more materials. The materials may be alloy or polymeric in nature. In some examples, the material composition of the guide element may vary in different areas of the segment along the length of the guide element or in various segments of the guide element. For example, the distal end may comprise one or more materials configured to conform, adjust, or otherwise change the shape or orientation of the distal segment. For example, the distal tip may be a first material, a segment adjacent to the distal tip may be a second material, and a segment adjacent thereto may be a third material. The second material may have different properties from the first and third materials, causing the second material segment 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, a segment may contract at a faster rate when at a cooler temperature compared to other segments, thereby causing a predetermined curvature or bend in the segment. In some examples, a segment may contract at a faster rate than another segment when subjected to higher tension caused by the braid, thereby causing a predetermined curvature or bend in the segment. In some examples, a guide element may have two or more annular segments, and each annular segment may comprise a different material and / or may be made of a material having different properties, such as stiffness, malleability, hardness, conductivity, etc. For example, one annular element may comprise a material that is hard enough to be advanced through the occlusion without causing the guide element to bend or kink when advanced through the occlusion, 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.

[0050]

[0060] 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 substitution for any elements, devices, systems, compositions, examples, components, processes, methods, method steps, etc. described in PCT Application No. PCT / US23 / 84427, entitled "HYPODERMIC NEEDLES AND METHODS OF MANUFACTURE," filed December 15, 2023, and / or PCT Application No. PCT / US23 / 86107, entitled "INTRAVASCULAR ACCESS DEVICE," filed December 27, 2023, the entireties of which are incorporated herein by reference.

[0051]

[0061] 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.

[0052]

[0062] 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.

[0053]

[0063] 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 " / ."

[0054]

[0064] 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.

[0055]

[0065] 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.

[0056]

[0066] 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.

[0057]

[0067] 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.

[0058]

[0068] 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.

[0059]

[0069] 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.

[0060]

[0070] 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. An intravascular access guide element for use in 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; b. a guide element having a shaft on a proximal end and a tip at a distal end, a portion of said distal end having an outer shape adapted and configured to at least partially conform to the inner surface of the catheter and the outer surface of the needle, the guide element configured for distal and proximal movement along said working space and for further distal advancement from said intravascular access device within and along a blood vessel; c) an intravascular access guide element, wherein the tip on a distal-most end of the guide element has a rounded distal end and a preset curvature, and wherein the tip begins to transition to the preset curvature as the guide element is advanced so that the tip exits the working space, and further wherein the shaft is one of a wire, a braid, or a combination of wire and braid.

2. 10. The intravascular access guide element of claim 1, wherein the tip further comprises an open interior portion on the proximal end, the proximal end portion being sized and shaped to receive the distal-most end of the shaft.

3. The intravascular access guide element of claim 2 , wherein the shaft is a wire having one or more deformations to increase the surface area of ​​the wire within the tip proximal end portion.

4. The intravascular access guide element of claim 2 , wherein the shaft is braided.

5. The intravascular access guide element of claim 2 , wherein the shaft is a combination of wire and braid, the wire and braid joined by one or more crimping zones.

6. The intravascular access guide element of any of claims 1 to 5, wherein the tip on the distal-most end of the guide element is an atraumatic tip.

7. 6. The intravascular access guide element of claim 1, wherein a section of the needle's circumference is removed or formed into a flat, convex, or concave shape to create a working space within an inner arc of the catheter inner surface and the needle surface, and a portion of the distal end of the guide element at least partially conforms to the inner arc.

8. 6. The intravascular access guide element of claim 1, wherein a portion of the needle section is removed or configured to create a combined working and blood flashback space within the inner arc of the catheter inner surface and the needle surface.

9. 1. An intravascular access device comprising: a handle having a proximal end and a distal end, 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 surface extending longitudinally along a periphery of the access needle adapted to engage a portion of a guide element, and a tissue-piercing tip extending distally beyond the catheter lumen; a working space within the catheter along the length of at least one surface of the access needle, the working space configured to facilitate passage of the guide element therethrough distally from the proximal end of the intravascular access device into a blood vessel; a slider extending through the slot and coupled to a proximal portion of the guide element of a first configuration such that distal advancement of the slider advances a distal tip portion of the guide element of a second, different configuration distally along the at least one surface of the access needle from a position contacting the guide element notch.

10. The intravascular access device of claim 9 , wherein the at least one surface of the access needle extends longitudinally along an outer surface of the access needle.

11. The intravascular access device of claim 9 or claim 10, wherein the working space is defined by the needle surface and the inner surface of the catheter, and the working space is selectively accessible from the proximal end of the intravascular access device.

12. The intravascular access device of claim 11 , wherein the working space is configured to selectively open at the catheter distal end, the working space being configured to guide a tool or tool segment sliding therethrough.

13. The intravascular access device of any of claims 9 to 12, wherein the access needle comprises a plurality of flat surfaces, each flat surface being associated with a separate working space within the catheter lumen.

14. The intravascular access device of any of claims 9 to 13, further comprising an actuation button coupled to the needle holder and an actuation element that applies a force to 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 access needle toward the proximal end of the handle.

15. The intravascular access device of claim 14 , wherein the access needle is configured to be retracted proximally toward the handle and the guide element to remain in a distally advanced position.

16. The venous access device of claim 9, wherein the first structure or the second structure of the guide element is made completely or partially of a metallic material, a polymeric material, or a combination thereof.

17. The venous access device of any of claims 1-16, wherein the guide element comprises a plurality of sections, one or more of the plurality of sections comprising different materials.

18. 17. The venous access device of any of claims 1-16, wherein the first structure or second structure of the guide element is a wire, braid, or combination formed completely or partially of a metallic material, a polymeric material, or a combination thereof.

19. 10. The venous access device of claim 9, wherein the access needle has at least one surface extending longitudinally along the circumference of the access needle, the at least one surface being a section of the needle's circumference that is removed or formed into a flat, convex, or concave shape to create a working space within an inner arc of the catheter inner surface, and wherein at least a portion of the surface is adapted and configured to conform to an outer surface of a guide element distal end or guide element tip.

20. 10. The intravascular access guide element of claim 1, further comprising one or more radiopaque marker bands extending along the longitudinal axis of the catheter and interior to a sidewall of the catheter, each of the one or more radiopaque markers having a rectangular body and a beveled tip, the beveled tip directed toward the distal-most end of the catheter.

21. 21. The intravascular access guide element of claim 20, wherein each radiopaque marker of the one or more radiopaque markers is evenly spaced from each of the other one or more radiopaque markers around the circumference of the catheter.

22. 10. The venous access device of claim 9, further comprising one or more radiopaque marker bands extending along the longitudinal axis of the catheter and within a sidewall of the catheter, each of the one or more radiopaque markers having a rectangular body and a beveled tip, the beveled tip directed toward the distal-most end of the catheter.

23. 23. The venous access device of claim 22, wherein each radiopaque marker of the one or more radiopaque markers is evenly spaced from each of the other one or more radiopaque markers around the circumference of the catheter.

24. 2. The intravascular access guide element of claim 1, wherein the outer surface of the needle is flat and a portion of the guide element tip distal end conforms to the flat portion of the needle, or the outer surface of the needle has a groove and a portion of the guide element tip distal end conforms to the shape, curvature, or orientation of the groove.

25. 10. The venous access device of claim 9, wherein the access needle includes a flattened portion having at least one surface extending longitudinally along a periphery of the access needle adapted to engage a portion of a guide element, and a portion of the guide element distal tip conforms to the flattened portion of the needle, or the at least one surface of the needle has a groove and a portion of the guide element tip distal end conforms to the shape, curvature, or orientation of the groove.

26. The venous access device of claim 1 , wherein the guide element is molded onto the distal section of the shaft.

27. The venous access device of claim 1 , wherein a distal section of the shaft is affixed to the interior of the guide element.

Images