Echo-source catheter and catheter system

Abstract

To provide a medical instrument or device, such as a catheter, having echogenic properties in addition to or as an alternative to radiopaque properties, to facilitate detection of the medical instrument or device during medical procedures using suitable imaging methods, such as ultrasound imaging and / or x-ray imaging methods.SOLUTION: In example embodiments, an example catheter has a relatively increased radiopacity and echogenicity to make it easy for a clinician to detect the catheter with ultrasound imaging and / or x-ray imaging methods so as to assist the clinician with the insertion, placement and / or maintenance of the catheter, for example.SELECTED DRAWING: Figure 2

Description

Technical Field

[0001] This application generally relates to medical devices or instruments having echogenic properties or features in addition to, or instead of, radiopaque properties or features to facilitate the detection of the medical devices or instruments during medical procedures using suitable imaging methods such as ultrasound imaging and / or X-ray imaging. More particularly, this application relates to catheters having echogenic properties or features in addition to, or as an alternative to, radiopaque properties or features to facilitate the detection of the catheter by ultrasound imaging and / or X-ray imaging to assist clinicians, for example, in the insertion, placement, and maintenance of a catheter during intravascular (IV) therapy.

Background Art

[0002] Peripheral IV catheter placement is the most common invasive hospital technique and is required by up to 90% of inpatients. Clinical guidelines recommend removing an IV catheter when clinically necessary, but up to 50% of placed IV catheters are removed earlier than intended due to complications associated with IV catheter placement.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

Patent Document 5

Patent Document 6

[0004] Placing an IV catheter under the skin of a patient, particularly a patient with "difficult venous access" (DVA), can be difficult. When a catheter is inserted into the vein of a DVA patient, an ultrasound device is frequently used to allow the clinician to visualize the patient's anatomical structure and guide the IV catheter and needle to the appropriate position to facilitate IV therapy. However, the use of ultrasound imaging technology requires a skilled clinician and an expensive ultrasound imaging device. Additionally, while ultrasound imaging can be useful for detecting relatively dense substances, it cannot detect low-density substances such as conventional catheters. The ability to detect a catheter using ultrasound imaging is particularly important for maintaining a properly placed IV catheter during, for example, IV therapy, and / or retrieving a dislodged, malfunctioning, or damaged catheter after the needle has been removed. [Means for Solving the Problems]

[0005] Brief Summary of Some Exemplary Embodiments In one aspect, a medical device includes a catheter adapter and a cannula extending distally from the catheter adapter. The cannula forms a lumen having a length between a first end of the cannula and an opposite second end. The lumen extends parallel to the longitudinal axis of the cannula and along at least a portion of the length. The cannula includes at least one echogenic stripe extending along at least a portion of the length of the cannula.

[0006] In another aspect, the catheter has a distal end and an opposite proximal end. The catheter includes a catheter adapter and a cannula extending distally from the catheter adapter. The cannula forms a lumen that extends between the distal and proximal ends of the catheter parallel to the longitudinal axis of the catheter. One or more stripes are formed on the cannula. The one or more stripes extend along at least a portion of the length of the cannula. The one or more stripes have echogenic properties or characteristics.

[0007] In yet another aspect, a method for forming stripes on the cannula of a catheter includes extruding a thermoplastic polymer material through an array of aligned dies such that stripes having echogenic properties or characteristics are formed between and bonded to adjacent wall portions of the cannula wall formed of a second thermoplastic polymer material that consists of a first thermoplastic polymer material.

[0008] The detailed description is set forth with reference to the accompanying drawings, which show non-limiting and non-exhaustive embodiments. The same reference numbers in different drawings refer to similar or identical items.

Brief Description of the Drawings

[0009]

Figure 1

Figure 2

Figure 3

Figure 4

Modes for Carrying Out the Invention

[0010] Detailed Description Various embodiments are described below with reference to the drawings in which like elements are generally referred to by like numerals. The relationships and functions of the various elements of the embodiments can be better understood with reference to the following detailed description. However, the embodiments are not limited to what is shown in the drawings. The drawings are not necessarily drawn to scale and, in some cases, details not necessary for an understanding of the embodiments disclosed herein, such as conventional manufacturing and assembly, may be omitted. It should be understood that the present invention is defined by the claims and can be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete and will fully convey the disclosure to those skilled in the art. As used herein and in the claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. References herein to any industry standards (such as ASTM, ANSI, IEEE standards, etc.) are defined as conforming to the generally published standards as of the filing date of the original application of this disclosure with respect to the units, measurements, and inspection criteria conveyed by these standards, unless otherwise defined explicitly herein. As used herein, the terms “proximal” and “distal” are used in their ordinary sense of referring, respectively, to the handle / doctor side and the tool / patient side of an instrument or associated object. The terms “about,” “substantially,” “generally,” and other terms of degree, when used with respect to any volume, dimension, ratio, or other quantitative or qualitative value, are intended to convey a value that is clearly distinguishable within the standard parameters understood by one of ordinary skill in the art (equivalent to a medical device technician with experience in this field) and includes at least any legal equivalents, minor but functionally insignificant variations, standard manufacturing tolerances, and includes at least numerically significant values (although not necessarily as broad as the maximum range).

[0011] The present invention is defined by the claims and can be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete and will fully convey the disclosure to those skilled in the art. As used herein and in the claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. References herein to any industry standards (such as ASTM, ANSI, IEEE standards, etc.) are defined as conforming to the generally published standards as of the filing date of the original application of this disclosure with respect to the units, measurements, and inspection criteria conveyed by these standards, unless otherwise defined explicitly herein. As used herein, the terms “proximal” and “distal” are used in their ordinary sense of referring, respectively, to the handle / doctor side and the tool / patient side of an instrument or associated object. The terms “about,” “substantially,” “generally,” and other terms of degree, when used with respect to any volume, dimension, ratio, or other quantitative or qualitative value, are intended to convey a value that is clearly distinguishable within the standard parameters understood by one of ordinary skill in the art (equivalent to a medical device technician with experience in this field) and includes at least any legal equivalents, minor but functionally insignificant variations, standard manufacturing tolerances, and includes at least numerically significant values (although not necessarily as broad as the maximum range).

[0012] In the exemplary embodiments described herein, an exemplary medical device or instrument, such as a catheter, has echogenic properties or characteristics in addition to, or instead of, radiopaque properties or characteristics, facilitating the detection of the medical device or instrument during a medical procedure using a suitable imaging method, such as ultrasound imaging and / or X-ray imaging. For example, in certain embodiments, the exemplary catheter has a relatively increased echogenicity, facilitating a clinician's detection of the catheter by ultrasound imaging, for example, assisting the clinician with respect to catheter insertion and / or maintenance.

[0013] In an exemplary embodiment, increased radiopacity or radiation density increases the relative inability of a particular electromagnetic radiation, such as an electromagnetic wave, or the X-ray portion of the electromagnetic spectrum, to pass through a particular material. The radiopaque volume of the material has a white appearance in an X-ray photograph as compared to the relatively darker appearance of the radiolucent volume. For example, in a typical X-ray photograph, bone appears white or light gray (radiopaque), while muscle and skin appear black or dark gray and are mostly invisible (radiolucent). A radiopaque agent included in a medical device enhances the visualization of the medical device during implantation for a temporary implant device such as a catheter or guidewire, or for monitoring the position of a permanently implanted medical device such as a stent, hip or knee implant, screw. Metal implants typically have sufficient radiopacity and do not require an additional radiopaque agent, while polymer-type devices may require the incorporation of materials having a high electron density contrast compared to the surrounding tissue. Examples of suitable radiopaque agents include titanium oxide, tungsten, barium sulfate, zinc oxide, iron oxide, platinum oxide, and zirconium oxide.

[0014] Instead, or in addition, increased echogenicity increases the ability of a medical device to reflect an echo, e.g., to return a signal during an ultrasound examination. For example, when gas voids, cores, or bubbles are captured in the ultrasonic frequency field, the gas voids, cores, or bubbles compress or vibrate to reflect characteristic echoes, generating a powerful and unique sonogram in contrast-enhanced ultrasound. In certain embodiments, the gas voids, cores, or bubbles are composed of air or a heavy gas, e.g., a suitable gas such as perfluorocarbon or nitrogen.

[0015] When a catheter is inserted into a vein of a "difficult venous access" (DVA) patient, an ultrasound device is frequently used to assist the clinician in visualizing the patient's anatomical structure and guiding the IV catheter needle and catheter to the appropriate position to facilitate IV therapy. Although the use of ultrasound is useful, it can be difficult to learn and acquire. For example, the plane of the ultrasound beam is very thin - on the order of thousandths of an inch in thickness or width - and it can be difficult for the clinician to see the catheter and associated needle when using ultrasound for catheter and needle placement.

[0016] Some conventional catheters or needles are echogenic (the catheter or needle is made more visible by ultrasound imaging). In these conventional catheters or needles, material is added, the surface finish is changed, or it is made less smooth to better reflect ultrasonic energy. The increased surface roughness reflects ultrasonic energy and appears in the ultrasound image. However, an increase in the material of the catheter or needle, or an increase in the surface roughness of the catheter or needle, can undesirably promote thrombus formation and / or blood clotting.

[0017] In the exemplary embodiments described herein, an echogenic enhancing composition is added to the radiopaque stripe of the catheter tube (e.g., gas bubbles, chemically formed bubbles, glass balloons, voids, irregularities, and / or relatively dense materials such as tungsten, glass beads, or sand), while maintaining a smooth surface with the outer diameter (OD) and inner diameter (ID) of the catheter tube. In certain embodiments, for example, substantially transparent tungsten particles having an average diameter of less than 100 nanometers (nm) are added to the radiopaque stripe to provide an increased radiopaque response and increased flashback visibility. Improving the echogenic composition of the stripe can be achieved in various ways as described herein. For example, in certain exemplary embodiments, when the material is co-extruded with a conventional catheter material, a chemical blowing agent is added to the radiopaque material of the stripe to provide these advantages and maintain a very smooth finish on the surface that can contact body fluids such as blood. In an alternative exemplary embodiment, at least a portion of the outer surface of the cannula and / or at least a portion of the inner surface of the cannula forming the lumen includes an intentionally regularly patterned surface.

[0018] Referring now to the figures, and initially to FIGS. 1 - 3, an exemplary catheter 10 has a distal end 12 and an opposite proximal end 14. The catheter 10 includes a catheter adapter 15 and a cannula 16 extending distally from the catheter adapter 15. In an exemplary embodiment, the catheter adapter 15 is configured to couple the catheter 10 to a small - bore luer - taper - lock fitting. The cannula 16, in certain exemplary embodiments, has a length extending from the distal end 12 to the opposite proximal end 14 of the catheter 10. The catheter 10 forms or defines a lumen 18 that extends between the distal end 12 and the proximal end 14 of the catheter 10 along or parallel to the longitudinal axis 20 of the catheter 10. In an exemplary embodiment, the cannula 16 has an outer diameter (OD) and an inner diameter (ID) that forms the lumen 18 extending through the catheter 10, and in certain embodiments, includes a capillary tube that extends proximally beyond the distal end of the catheter adapter 15. Further, referring to FIGS. 2 and 3, in an exemplary embodiment, the outer surface 22 of the cannula 16 (defining the outer diameter of the cannula 16) and the opposing inner surface 24 of the cannula 16 that forms the lumen 18 (defining the inner diameter of the cannula 16) include smooth, antithrombogenic surfaces that prevent or limit the accumulation of tissue and / or fluid at the surface, such as blood clotting or coagulation at the outer surface 22 and the inner surface 24.

[0019] In an exemplary embodiment, the catheter adapter 15 is configured to couple to a cooperating small - bore fitting or connector, tube, hub, or another suitable connector, and the lumen 18 provides a fluid flow path through the catheter 10. In an exemplary embodiment, the lumen 18 has a suitable diameter or suitable cross - sectional dimensions to facilitate the flow of fluid through the catheter 10. Additionally or alternatively, the lumen 18 may accommodate a medical device or instrument, such as a needle or obturator, that is movably disposed within the lumen 18.

[0020] As shown in FIGS. 2 and 3, at least a portion of the catheter 10, e.g., at least a portion of the cannula 16 at the distal end 12 of the catheter 10, includes a plurality of stripes 30 having echogenic properties and / or characteristics, and / or radiopaque properties and / or characteristics, e.g., extending generally parallel to the longitudinal axis 20 of the catheter 10 along at least a portion of the length of the catheter 10. In an exemplary embodiment, the stripes 30 are formed on the cannula 16 using suitable methods or techniques to maintain the smooth outer surface 22 and inner surface 24 of the cannula 16. For example, the cannula 16 is formed through an array of aligned dies such that each stripe 30 is formed between and bonded to adjacent transparent wall portions 32 of the wall 34 of the cannula 16 by extruding a suitable material, e.g., a biocompatible thermoplastic polymer material such as polyurethane or fluoropolymer material, during a die extrusion process. In this extrusion process, a first thermoplastic polymer material is extruded through a plurality of sub-dies, e.g., six sub-dies, to form individual stripes 30 having echogenic properties and / or characteristics, and / or radiopaque properties and / or characteristics, and a second thermoplastic polymer material is extruded through a main die to form the transparent wall portions 32. As a result of this extrusion process, one or more stripes 30 are formed encapsulated within the wall 34 of the cannula 16 while maintaining the smooth outer surface 22 and smooth inner surface 24 of the cannula 16. Since only the stripes 30 include echogenic properties and / or characteristics, and / or radiopaque properties and / or characteristics, the surface finish of the cannula 16 is maintained. In an alternative exemplary embodiment, at least a portion of the outer surface of the cannula 16, and / or at least a portion of the inner surface of the cannula 16 forming the lumen 18, includes a surface that is intentionally and regularly patterned.Furthermore, the transparent or translucent wall portion 32 provides visibility to the clinician through the cannula 16, visualizing the blood flow through the lumen 18, i.e., the blood flow occurring in the annular space between the outer diameter of the needle inserted into the lumen 18 and the inner diameter of the cannula 16, and ensuring, for example, the proper placement of the needle tip within the patient's vein.

[0021] As described above, in an exemplary embodiment, the stripe 30 may include radiopaque properties or characteristics. In an exemplary embodiment, the stripe 30 includes a biocompatible thermoplastic polymer material filled with a material or substance opaque to X-rays, thereby making the stripe 30 visible under fluoroscopy or X-ray imaging. These fillers, or radiopaque agents such as, for example, high-density metal powders, affect the energy attenuation of photons in the X-ray beam when the X-ray beam passes through the stripe 30, reducing the intensity of the photons by absorbing or deflecting them. Since the stripe 30 exhibits a higher attenuation coefficient than soft tissue or bone, the stripe 30 will appear brighter on a fluoroscope or X-ray film. This visibility may provide the contrast necessary to accurately position or place the catheter 10 in the desired vein. In certain embodiments, the contrast and sharpness of the image may be varied by the type and / or amount of radiopaque agent within the stripe 30 and adapted to the particular use of the catheter 10.

[0022] For example, in the case of a thin-walled catheter cannula or tube, more filling with a radiopaque material may be required than in the case of a thick-walled catheter cannula or tube. To prevent overfilling that could result in a loss of the mechanical properties of the material, the amount of additive may also be limited. Radiopaque agents suitable for the stripe 30 include, without limitation, barium sulfate, bismuth compounds (bismuth trioxide, basic bismuth carbonate, or bismuth oxychloride), tungsten, titanium, and zirconium oxide, including metals that are excellent absorbers of X-rays. A blend of one or more radiopaque materials, such as barium sulfate and a bismuth compound, may be incorporated into the stripe 30.

[0023] In addition to or as an alternative to the radiopaque property or characteristic, in an alternative embodiment, stripe 30 includes an echo-source property or characteristic. For example, as shown in FIG. 3, in an exemplary embodiment, stripe 30 includes a plurality of voids 32 between the outer surface 22 and the inner surface 24 of cannula 16. In a particular exemplary embodiment, the plurality of voids 32 includes gas pockets or air bubbles, e.g., air pockets or air bubbles, formed within the thickness of each stripe 30 between the outer surface 22 and the inner surface 24 of cannula 16. The voids 32 can be formed in stripe 30 by injecting a gas, e.g., air, into the thermoplastic polymer material used to form stripe 30 during the extrusion process as described above. When gas is directly injected into the thermoplastic polymer material during the extrusion process, voids 32 are formed in stripe 30, enhancing the echo-source property of stripe 30.

[0024] The voids 32 can be formed in stripe 30 using other suitable methods. For example, in an exemplary embodiment, a chemical blowing agent is added to the thermoplastic polymer material. In this embodiment, the chemical blowing agent decomposes during the extrusion process to produce a gas that forms gas bubbles creating the voids 32. Alternatively, various materials such as ceramic beads or particles (e.g., glass or carbon beads or particles), metal beads or particles, and / or expandable thermoplastic foaming agents and / or lightweight fillers (e.g., Expancel™ microspheres) can be added to the thermoplastic polymer material to create the voids 32. In certain embodiments, the void-forming process can include a combination of these and / or other methods.

[0025] In an exemplary alternative embodiment, also shown in FIG. 3, stripe 30 includes one or more irregularities 36 formed in one or more stripes 30, e.g., a plurality of irregularities or discontinuities 36. The one or more irregularities or discontinuities 36 include, without limitation, one or more ridges, grooves, valleys, hills, ridges, and / or undulations, which can enhance the echo-source reflection characteristics of the stripe. For example, the shape and / or contour of stripe 30 can be changed from a general elliptical cross-section to, for example, a cross-sectional shape and / or contour having ridges, grooves, valleys, hills, ridges, undulations, and / or flower petals, optimizing the echo-source enhancement characteristics of stripe 30 for ultrasonic imaging methods. In certain embodiments, the change in the cross-sectional shape of stripe 30, and / or the irregularities or discontinuities 36 on the outer surface of stripe 30, or the formation of non-planar aspects, can potentially enhance the echo-source characteristics of stripe 30 without the need to add any additives to stripe 30. These changes to the cross-sectional shape of stripe 30 can be effected by using a die having a corresponding profile or cross-sectional area, rather than a conventional die having a circular or elliptical cross-sectional area.

[0026] In an alternative embodiment, stripe 30 may include a suitable, relatively high-density material that can create the echo-source enhancing properties of stripe 30. For example, stripe 30 may include a relatively high-density material 31 such as sand, silica, microparticles, and / or glass beads. This high-density material may also enhance the radiopacity of stripe 30. Combinations of these methods that create the echo-source enhancing properties of stripe 30 may be used to offset a potential reduction in radiopacity resulting from the formation of voids 32 in stripe 30. Thus, the methods described herein may be utilized to form stripe 30 that is optimized to provide both echo-source and radiopacity properties or characteristics. In an alternative exemplary embodiment, at least a portion of catheter 10, e.g., at least a portion of cannula 16, includes one or more stripes 30 formed of, or including, an echo-source and radiopaque wire, such as a suitable metal wire, for example.

[0027] Echo-source features may be offset, stepped, or arranged to better detect catheter 10. For example, the echo-source properties of catheter 10, or a system including, for example, a needle, catheter 10, and / or a flashback notch, may be segmented with echo-source features or properties and non-echo-source features or properties to provide additional information regarding, for example, the tip, depth, and placement of the needle.

[0028] Referring again to FIG. 1, at the proximal end 14, the catheter 10 includes an adapter such as a small-bore connector 40. The small-bore connector 40 is configured to removably couple to any suitable medical instrument or component, such as a cooperating small-bore fitting, instrument, or medical tube. The medical instrument, component, or tube includes a cooperating element such as a cooperating small-bore connector, which may facilitate, for example, the coupling of the medical instrument, component, or tube to the catheter 10. In an exemplary embodiment, the small-bore connector 40 includes a twist-lock mechanism for removably coupling the small-bore connector 40 to a cooperating small-bore connector having a cooperating twist-lock mechanism. The small-bore connector 40 can be easily removed from the cooperating small-bore connector by rotating the small-bore connector 40 in the opposite direction relative to the cooperating connector to unscrew the threads. In an alternative exemplary embodiment, the small-bore connector 40 can be a slip small-bore fitting that is pressed against a cooperating small-bore connector.

[0029] Referring to FIG. 4, in a further embodiment, as described herein, the echogenic, and in some embodiments, radiopaque catheter 10 can be combined with other complementary medical devices or instruments such as a needle 52, for example, to facilitate access to the vein of a DVA patient. The following are some exemplary combinations of instruments, properties, and / or features that can provide an exemplary catheter system 50 including the exemplary catheter 10 described herein.

[0030] A combination of echogenic needle (or needle tip) technologies for providing echogenic needles and echogenic catheters, as described in the echogenic catheter disclosed and echogenic needles and echogenic catheters, incorporated herein by reference in their entirety, such as U.S. Patent Application No. 12 / 930,580, entitled "Ultrasound-Guided Echogenic Catheter and Related Methods," U.S. Patent Publication No. 2011 / 0172542, and U.S. Patent Application No. 15 / 297,731, entitled "Echogenic Needle," U.S. Patent Publication No. 2017 / 0112464. the disclosed echo-source catheter and the combination of magnetic needle (and pre-magnetized) technology as shown in FIG. 4, described in, for example, U.S. Patent Application No. 15 / 154,353, titled "Invasive Medical Device Cover with Magnet", U.S. Patent Publication No. 2017 / 0325713, which is hereby incorporated by reference in its entirety; U.S. Patent Application No. 15 / 154,362, titled "Electromagnetic Needle Catheter Insertion System", U.S. Patent Publication No. 2017 / 0325714, which is hereby incorporated by reference in its entirety; U.S. Patent Application No. 15 / 170,518, titled "Medical Devices, Systems and Methods Utilizing Permanent Magnets and Magnetizable Functions", U.S. Patent Publication No. 2017 / 0348510, which is hereby incorporated by reference in its entirety; U.S. Patent Application No. 15 / 170,497, titled "Invasive Medical Devices, Systems and Methods Comprising Magnetic Regions", U.S. Patent Publication No. 2017 / 0347913, which is hereby incorporated by reference in its entirety; U.S. Patent Application No. 15 / 170,531, titled "Invasive Medical Devices, Systems and Methods Comprising Magnetic Regions", U.S. Patent Publication No. 2017 / 0347914, which is hereby incorporated by reference in its entirety; and U.S. Patent Application No. 62 / 481,964, titled "System for Visualization of Insertion of a Vascular Access Device with Multiple Magnetic Features on a Needle Assembly", which is hereby incorporated by reference in its entirety. the disclosed echo-source catheter and the combination with guidewire placement techniques for providing an echo-source needle tip, a magnetic needle tip and an echo-source catheter in a device or system as described in, for example, U.S. Patent Application No. 15 / 604,244, titled "Medical Devices, Systems and Methods Utilizing Permanent Magnets and Magnetizable Features", U.S. Patent Publication No. 2017 / 0348511, which is hereby incorporated by reference in its entirety. the disclosed echo-source catheter and the combination with, for example, a reduced bevel length or a shortened needle shape for better first stick success as described in U.S. Patent Application No. 62 / 541,205, titled "Introducer Needle for Catheter Placement", filed on August 4, 2017, which is hereby incorporated by reference in its entirety, and / or The disclosed echo - source and radioactive catheters, in combination with an antibacterial, silver coating, or an anti - infectious coating such as a copper coating, as described in U.S. Patent Application No. 14 / 326,036, U.S. Patent Publication No. 2016 / 0008517, which are hereby incorporated by reference in their entirety, and titled, for example, "Antibacterial Coating and Kink - Resistant Function for Vascular Access Devices".

[0031] The subject matter is described in language specific to structural features and / or methodological acts, but it should be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or acts described. Rather, the specific features and acts are disclosed as exemplary forms of carrying out the claims. Those skilled in the art will understand that a virtually unlimited number of variations are possible with respect to the above description, and that the examples and the accompanying drawings are merely for the purpose of illustrating one or more examples of implementation. It will be understood by those skilled in the art that various other modifications can be made without departing from the claimed subject matter and equivalents can be substituted. Furthermore, many modifications can be made to adapt a particular situation to the teachings of the claimed subject matter without departing from the core concepts described herein. Accordingly, the claimed subject matter is not limited to the specific embodiments disclosed, and it is intended that such claimed subject matter may include all embodiments within the scope of the appended claims and their equivalents.

[0032] In the above detailed description, numerous specific details are set forth in order to provide a thorough understanding of the claimed subject matter. However, it will be understood by those skilled in the art that the claimed subject matter may be practiced without these specific details. In other instances, methods, apparatuses, or systems that would be known to those skilled in the art are not described in detail so as not to obscure the claimed subject matter.

[0033] References to "one embodiment" or "an embodiment" throughout this specification may mean that a particular feature, structure, or characteristic described in connection with the particular embodiment may be included in at least one embodiment of the claimed subject matter. Thus, appearances of the phrases "in one embodiment" or "an embodiment" in various places throughout this specification are not necessarily intended to refer to the same embodiment or any of the particular embodiments described. Further, it is to be understood that the particular features, structures, or characteristics described may be combined in any suitable manner in one or more embodiments. Of course, generally, these issues and others may vary depending on the specific context of use. Thus, the specific context of the description or the use of these terms may provide useful guidance regarding the inferences drawn in that situation.

[0034] Various implementations have been specifically described. However, many other implementations are possible.

[0035] Those skilled in the art will understand that embodiments not explicitly shown in this specification, including the combinations of the features described herein for different embodiments with each other and / or with currently known or future-developed technologies, may be practiced within the scope of the claims. Although specific terms are used in this specification, they are used only in a general and descriptive sense and not for purposes of limitation, unless clearly defined by context, usage, or other explicit designation. Accordingly, the foregoing detailed description is intended to be illustrative rather than limiting. It is understood that the following claims, including all equivalents, are intended to define the spirit and scope of the invention. Further, the above advantages are not necessarily the only advantages of the invention, and it is not necessarily expected that all of the recited advantages will be achieved in all embodiments. In any inconsistent disclosure or definition from this application that conflicts with any document incorporated by reference, the disclosure or definition herein is likely to prevail.

Claims

Claim 1 A medical device, a catheter adapter, and the cannula forming a lumen having a length between a first end and a second end opposite the first end of the cannula, the lumen extending parallel to the longitudinal axis of the cannula and along at least a portion of the length, the cannula including a wall and a plurality of stripes encapsulated in the wall and extending along at least a portion of the length of the cannula, the plurality of stripes being formed of a first thermoplastic polymer material filled with both a plurality of radiopaque agents and a plurality of echogenic voids, the wall being formed of a second thermoplastic polymer material filled with neither a radiopaque agent nor an echogenic void, forming an outer surface of the cannula and an inner surface of the cannula adjacent to the lumen, the first thermoplastic polymer material being bonded to the second thermoplastic polymer material, each of the plurality of stripes being encapsulated in the second thermoplastic polymer material, the plurality of echogenic voids forming an irregular outer surface of each of the plurality of stripes, the plurality of echogenic voids being spaced from the outer surface of the cannula and the inner surface of the cannula, and the outer surface of the cannula and the inner surface of the cannula having a shape unaffected by the plurality of echogenic voids and being smooth, the cannula; A medical device characterized by comprising the above. Claim 2 The medical device according to claim 1, wherein each of the plurality of stripes includes a plurality of glass beads or sand formed therein. Claim 3 A method of forming one stripe of a plurality of stripes on a cannula of a catheter of the medical device according to claim 1, the method comprising extruding a portion of a thermoplastic polymer through an array of aligned dies such that the stripe is formed of the first thermoplastic polymer material. Claim 4 The method according to claim 3, further comprising injecting a gas into the first thermoplastic polymer material used to form the stripe to form voids in the stripe. Claim 5 The method according to claim 3, further comprising adding a chemical blowing agent to the first thermoplastic polymer material used to form the stripe to form voids in the stripe.

6. The method according to claim 3, further comprising adding ceramic beads or particles, metal beads or particles, and / or expandable thermoplastic blowing agents, and / or lightweight fillers to the first thermoplastic polymer material used to form the stripe to form voids in the stripe.

7. The method according to claim 3, wherein the stripe has a radiopaque property or characteristic.

8. The medical device according to claim 1, wherein the second thermoplastic polymer material forms a plurality of transparent wall portions between the plurality of stripes.

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