Catheters with reinforced fibers and related devices and methods

Abstract

The catheter assembly may include a catheter adapter, which may include a distal end and a proximal end. The catheter assembly may include a catheter extending from the distal end of the catheter adapter. The catheter may include a shaft and a lumen extending through the shaft. The shaft may include a wall and a plurality of reinforcing fibers within the wall. Each of the reinforcing fibers may have a higher tensile strength than the wall, increasing the kink resistance and strength of the catheter.

Description

[Technical Field]

[0001] The present invention relates to catheters having reinforcing fibers and related devices and methods. [Background technology]

[0002] Catheters are commonly used for various infusion therapies. For example, catheters can be used to infuse therapeutic agents or fluids into patients. Catheters can also be used to withdraw blood from patients. There are various types of catheters commonly used in medical settings, including peripherally inserted central catheters, midline catheters, central venous catheters, dialysis catheters, and arterial catheters. In some instances, catheters may be inserted into a patient's blood vessels via a modified Seldinger technique or Seldinger technique. A common type of catheter device is the "over-the-needle" catheter. As the name suggests, an over-the-needle catheter may be mounted over an introducer needle with a sharp distal tip. A catheter assembly may include a catheter hub, a catheter extending distally from the catheter hub, and an introducer needle extending through the catheter.

[0003] The catheter and introducer needle may be assembled so that the distal tip of the introducer needle extends beyond the distal tip of the catheter, with the needle bevel pointing away from the patient's skin. The catheter and introducer needle are typically inserted into the patient's vasculature at a shallow angle from the skin. To verify proper placement of the introducer needle and / or catheter within the vessel, clinicians typically confirm the presence of a "flashback" of blood within the flashback chamber of the catheter assembly. Once needle placement is confirmed, the catheter may be left in place for future blood withdrawals or fluid injections.

[0004] Unfortunately, kinks can form in a catheter shaft during use when the shaft is bent beyond its minimum bend or twist radius. When kinks form in a catheter shaft during use, one or more internal lumens within the shaft can become occluded, potentially disrupting the flow of therapeutic agents or fluids through the catheter. Therefore, it is desirable to provide a device that resists or prevents such kink-related blockages and interruptions in therapeutic agent or fluid delivery.

[0005] The subject matter claimed herein is not limited to embodiments that solve the problems or that operate only in the contexts described above. Rather, this background is only provided to illustrate one example technology area where some embodiments described herein may be practiced. Summary of the Invention

[0006]

[0001] The present disclosure relates generally to vascular access devices, systems, and methods. More specifically, the present disclosure relates to catheter assemblies and related devices and methods. In some embodiments, the catheter assembly may include a catheter adapter, which may include a distal end and a proximal end. In some embodiments, the catheter assembly may include a catheter extending from the distal end of the catheter adapter. In some embodiments, the catheter may include a shaft and a lumen extending through the shaft. In some embodiments, the shaft may include a wall and multiple reinforcing fibers within the wall. In some embodiments, each of the reinforcing fibers may have a higher tensile strength than the wall, which may facilitate kink resistance and strength of the catheter. In some embodiments, each of the reinforcing fibers may have a greater durometer than the wall, which may facilitate kink resistance and strength of the catheter. In some embodiments, the reinforcing fibers may improve the elastic elongation of the catheter or the tensile strength of the catheter itself at a particular durometer. In some embodiments, the reinforcing fibers may have a reduced elastic elongation compared to the wall.

[0007] In some embodiments, the reinforcing fibers may comprise nylon, aromatic polyamide fibers, KEVLAR™, carbon fibers, carbon nanotubes, glass fibers, silver nanowires, polymeric fibers, or another suitable fiber material. In some embodiments, the length of each of the reinforcing fibers may be between 10 microns and 1,000 microns. In some embodiments, the length of the reinforcing fibers may be short enough to facilitate bending of the catheter and allow the catheter to remain flexible, and the reinforcing fibers may also provide strength and anti-kink properties to the catheter. In some embodiments, the reinforcing fibers may also enhance other properties of the catheter, including electrical conductivity, stiffness, and / or thermal conductivity. In some embodiments, each of the reinforcing fibers may be encapsulated by a wall. In some embodiments, the distance of one or more reinforcing fibers from the longitudinal axis of the catheter may vary so that the depth of the reinforcing fibers within the shaft may vary. In some embodiments, the distal end of one or more reinforcing fibers may overlap the proximal end of one or more other reinforcing fibers, which may impart strength to the catheter. In some embodiments, the reinforcing fibers may be oriented approximately parallel to the central longitudinal axis of the catheter, which may increase the stiffness and strength of the catheter and make it more resistant to kinking.

[0008] Kink resistance is crucial for a catheter to maintain an open flow path. However, because it is often desirable to have a small catheter outer diameter while simultaneously having the largest possible catheter lumen for the highest flow rate, it is becoming increasingly difficult to provide kink resistance through catheter lumen shape and wall thickness alone. Due to the conflicting objectives of a small catheter outer diameter and a high flow rate through the catheter, avoiding catheter kinking can be difficult. In some embodiments, the reinforcing fibers may include a relatively short fiber strain, which allows the shaft and wall to be thin, facilitating high flow rates and allowing the shaft to bend easily without kinking. In some embodiments, the catheter may include a peripheral intravenous catheter (PIVC), a peripherally inserted central catheter (PIVC), a dialysis catheter, a midline catheter, a central venous catheter (CVC), or another suitable catheter.

[0009] In some embodiments, the shaft may include a wall, a stripe or annular layer within the wall, and reinforcing fibers within the stripe or annular layer. In some embodiments, the stripe or annular layer may be conductive, which may provide a path for transmitting and receiving electrical signals through the catheter. In some embodiments, each of the reinforcing fibers may have a higher tensile strength than the wall. In some embodiments, each of the reinforcing fibers may have a higher tensile strength than the stripe or annular layer. In some embodiments, the wall may include an inner surface that forms a lumen and an outer surface that forms the exterior of the catheter.

[0010] In some embodiments, the stripe may be adjacent to the inner surface and extend partially through the wall. In some embodiments, the stripe may be adjacent to the outer surface and extend partially through the wall. In some embodiments, the stripe may extend completely through the wall from the inner surface to the outer surface. In some embodiments, the shaft may include multiple stripes, which may include a stripe. In some embodiments, the stripes may be spaced around the circumference of the shaft. In some embodiments, the wall may completely surround each of the stripes. In some embodiments, the catheter may include another lumen extending through the shaft. In some embodiments, the shaft may include a stripe and another stripe. In some embodiments, the stripe and the other stripe may be on opposite sides of one lumen and completely surrounded by the wall.

[0011] In some embodiments, the annular layer may include an inner surface that forms the lumen and an outer surface that is adjacent to the wall. In some embodiments, the annular layer may extend along all or part of the entire length of the catheter. In some embodiments, the shaft may include the annular layer within its wall, and the wall may sandwich the annular layer.

[0012] In some embodiments, the wall may be composed of a first material, which may include, for example, a resin such as polyurethane. In some embodiments, the resin may provide some degree of torsional resistance. In some embodiments, the first material may include a polyurethane product, such as VIALON™ biomaterial, available from Becton, Dickinson and Company, Franklin Lakes, New Jersey. In some embodiments, the first material may be reinforced with reinforcing fibers to provide additional torsional resistance. In some embodiments, the stripe or annular layer may be composed of a second material different from the first material. In some embodiments, the second material may be of the same class of material as the first material to facilitate bonding between the first and second materials during extrusion. In some embodiments, the first and / or second material may include at least one of polyurethane, nylon, polyether block amide (PEBA), silicone, polypropylene, polyethylene, etc.

[0013] In some embodiments, one or more of the reinforcing fibers, stripes, and annular wall may be radiopaque (may contain barium sulfate or another suitable radiopaque compound) to facilitate visualization of the catheter during a medical procedure. In some embodiments, one or more of the reinforcing fibers, wall, stripes, and annular layer may be biocompatible, allowing for insertion into a patient's blood vessel. In some embodiments, the first material or the material of the catheter wall may contain an electrically conductive additive, which may provide a path for transmitting and receiving electrical signals through the catheter. In some embodiments, the reinforcing fibers may contain one or more antibacterial, anticoagulant, or antifouling compounds.

[0014] In some embodiments, a method of manufacturing a catheter can include providing an extrusion pin within an extrusion die. In some embodiments, the extrusion pin can include a body having a first diameter tapering to a nose having a second diameter. In some embodiments, the method can include flowing a polymeric material around an outer surface of the nose and through the extrusion pin. In some embodiments, the polymeric material can include reinforcing fibers. In some embodiments, in response to the polymeric material flowing around the outer surface of the nose and through the extrusion pin, the reinforcing fibers can be configured to orient toward a position aligned with a central longitudinal axis of the catheter. In some embodiments, the method can include withdrawing and / or drawing the polymeric material from the extrusion die. In some embodiments, in response to withdrawing and / or drawing the polymeric material from the extrusion die, the reinforcing fibers can be configured to further orient toward a position aligned with a central longitudinal axis of the catheter.

[0015] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the claimed invention. It is to be understood that the various embodiments are not limited to the arrangements and instrumentality shown in the drawings. Also, it is to be understood that embodiments may be combined or other embodiments may be utilized, and that structural changes may be made without departing from the scope of the various embodiments of the invention, unless so claimed. Therefore, the following detailed description is not to be taken in a limiting sense. [Brief explanation of the drawings]

[0016] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Figure 1A] FIG. 1A is a top perspective view of an exemplary catheter system, according to some embodiments. [Figure 1B]FIG. 1B is a longitudinal cross-sectional view of an exemplary catheter showing exemplary misaligned or randomly oriented reinforcing fibers, according to some embodiments. [Figure 2A] FIG. 2A is a cross-sectional view of an exemplary extrusion system, according to some embodiments. [Figure 2B] FIG. 2B is a top perspective view of an exemplary ejector pin, according to some embodiments. [Figure 2C] FIG. 2C is a longitudinal cross-sectional view of an exemplary catheter showing exemplary reinforcing fibers oriented generally aligned or parallel to the longitudinal axis of the catheter, according to some embodiments. [Figure 3] FIG. 3 is a longitudinal cross-sectional view of an exemplary catheter showing exemplary reinforcing fibers overlapping and oriented generally aligned or parallel to the longitudinal axis of the catheter, according to some embodiments. [Figure 4A] FIG. 4A is a cross-sectional view of an exemplary catheter showing a plurality of exemplary stripes, according to some embodiments. [Figure 4B] FIG. 4B is a longitudinal cross-sectional view of the catheter of FIG. 4A showing stripes, according to some embodiments. [Figure 5A] FIG. 5A is a cross-sectional view of an exemplary catheter showing exemplary stripes, according to some embodiments. [Figure 5B] FIG. 5B is a longitudinal cross-sectional view of the catheter of FIG. 5A showing stripes, according to some embodiments. [Figure 6A] FIG. 6A is a cross-sectional view of an exemplary catheter showing a plurality of exemplary stripes, according to some embodiments. [Figure 6B] FIG. 6B is a longitudinal cross-sectional view of the catheter of FIG. 6A showing stripes, according to some embodiments. [Figure 7A] FIG. 7A is a cross-sectional view of an exemplary catheter showing an exemplary annular layer, according to some embodiments. [Figure 7B] FIG. 7B is a longitudinal cross-sectional view of the catheter of FIG. 7A showing the annular layer, according to some embodiments. [Figure 8A] FIG. 8A is a cross-sectional view of an exemplary catheter showing an annular layer, according to some embodiments. [Figure 8B] FIG. 8B is a longitudinal cross-sectional view of the catheter of FIG. 8A showing the annular layer, according to some embodiments. [Figure 9A] FIG. 9A is a cross-sectional view of an exemplary catheter showing an annular layer, according to some embodiments. [Figure 9B] FIG. 9B is a longitudinal cross-sectional view of the catheter of FIG. 9A showing the annular layer, according to some embodiments. [Figure 10] FIG. 10 is a cross-sectional view of an exemplary catheter showing multiple exemplary lumens and exemplary stripes, according to some embodiments. [Figure 11] FIG. 11 is a cross-sectional view of an exemplary catheter showing an annular layer, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0017] Referring now to FIG. 1A , in some embodiments, a catheter system 10 may include a catheter assembly 11, which may include a catheter adapter 12 and a catheter 14 extending distally from the catheter adapter 12. In some embodiments, the catheter system 10 may include a needle assembly 16, which may include a needle hub 18 and an introducer needle 20. In some embodiments, the catheter 14 may be over-the-needle, and the introducer needle 20 may extend through the catheter 14 when the catheter system 10 is in an insertion configuration ready for insertion into a patient, for example, as shown in FIG. 1A . The catheter system 10 is merely one example of various catheter systems that may be used in accordance with the present disclosure. In some embodiments, the catheter assembly 11 may include any suitable catheter or needle assembly. In some embodiments, a catheter according to the present disclosure may not be over-the-needle but may include any other suitable type of catheter. In some embodiments, a catheter described in accordance with the present disclosure may include a peripherally inserted central catheter, a midline catheter, a central venous catheter, a dialysis catheter, an arterial catheter, or another type of catheter. In some examples, a catheter according to the present disclosure may be inserted into a patient's blood vessel via a modified Seldinger technique, a Seldinger technique, or another suitable technique.

[0018] 1B , in some embodiments, the catheter 14 may include a shaft 22 and a lumen 24 extending through the shaft 22. In some embodiments, the shaft 22 may include a wall 26 and a plurality of reinforcing fibers 28 within the wall 26. In some embodiments, the wall 26 may be annular. In some embodiments, the catheter 14 may include a distal end 30, which may be tapered, and a proximal end 32. In some embodiments, each of the reinforcing fibers 28 may include a greater tensile strength than the wall 26, which may facilitate kink resistance and strength of the catheter 14. In some embodiments, each of the reinforcing fibers 28 may be encapsulated by the wall 26. In some embodiments, the catheter 14 may include a central longitudinal axis 31.

[0019] In some embodiments, the reinforcing fibers 28 may comprise nylon, aromatic polyamide fibers, polyurethane, KEVLAR™, carbon fibers, carbon nanotubes, glass fibers, polymeric fibers, silver nanowires, or another suitable fiber material. In some embodiments, the length of each of the reinforcing fibers 28 may be between 10 microns and 1,000 microns. In some embodiments, the length of the reinforcing fibers 28 may be between 10 microns and 100 microns, 100 microns and 200 microns, 200 microns and 300 microns, 300 microns and 400 microns, 400 microns and 500 microns, 500 microns and 600 microns, 600 microns and 700 microns, 700 microns and 800 microns, 800 microns and 900 microns, or 900 microns and 1,000 microns. In some embodiments, the length of the reinforcing fibers 28 may be short enough to facilitate bending of the catheter 14 and allow the catheter 14 to remain flexible, while also providing strength and anti-kink properties to the catheter 14. In some embodiments, each of the reinforcing fibers 28 may be of uniform length to facilitate predictable anti-kink properties of the catheter 14.

[0020] In some embodiments, wall 26 may be constructed of a polymeric material, which may include, for example, a resin such as polyurethane. In some embodiments, the resin may provide some degree of torsional resistance. In some embodiments, the polymeric material may include a polyurethane product, such as VIALON™ biomaterial, available from Becton, Dickinson and Company, Franklin Lakes, New Jersey.

[0021] In some embodiments, the extrusion system used to create a particular catheter 14 of the present disclosure may vary. For example, the extrusion system may include multiple extrusion dies, multiple extrusion pins, and / or one or more baffles. In some embodiments, the catheter 14 extruded with reinforcing fibers 28 may be created using any number of standard extrusion processes known in the art, which may be specific to a particular thermoset or thermoplastic resin. In some embodiments, the extrusion process may include extruding the polymeric material through an extrusion die or dies and drawing down the extrusion, which may cause the reinforcing fibers 28 to be oriented generally axially of the extrusion or along the central longitudinal axis of the catheter 14.

[0022] Referring now to FIG. 2A , an extrusion system 34 is shown, according to some embodiments. The extrusion system 34 is merely one example of an extrusion system. In some embodiments, the extrusion system 34 may differ from that shown in FIG. 2A . In some embodiments, the extrusion system 34 may be used to orient the reinforcing fibers 28 parallel or generally parallel to the central longitudinal axis 31 of the catheter 14, which may increase the stiffness and strength of the catheter 14 and resist kinking. In some embodiments, the extrusion system 36 may include an extruder 38 that may be used to form the shaft 22 into a tubular shape. In some embodiments, the extruder 38 may include a hopper 40 that contains a quantity of the reinforcing fibers 28 mixed with a polymeric material 39 to form the tubular shape. In some embodiments, a screw 42 may deliver the polymeric material 39 and the reinforcing fibers 28 to an extrusion die 46 via a conduit 44. For example, a motor 48 may deliver rotational power to the screw 42 via a shaft 50 to extrude the polymeric material 39 and the reinforcing fibers 28 through the conduit 44 toward the extrusion die 46.

[0023] In some embodiments, the mandrel or extrusion pin 52 may be positioned within the extrusion die 46. In some embodiments, the extrusion pin 52 may be heated to an elevated temperature during the extrusion process. In some embodiments, the extrusion pin 52 may be housed within a cavity 54 of the extrusion die 46, leaving a gap between the extrusion pin 52 and the extrusion die 46 to allow the molten polymeric material 39 and reinforcing fibers 28 to flow (as indicated by the arrows in FIG. 2A ). In some embodiments, the extrusion pin 52 may be positioned within the extrusion die 46 such that the central longitudinal axis of the extrusion pin 52 is longitudinally aligned with the central longitudinal axis of the extrusion die 46. In some embodiments, the extrusion pin 52 may be secured within the extrusion die 46 by securing an end cap 56 to the rear of the extrusion die 46 using one or more fasteners or the like.

[0024] In some embodiments, after the extruded shaft 22 exits the extrusion die 46 through the opening 58 in the extrusion die 46, the shaft 22 may pass through a water bath 60 or other cooling device. In some embodiments, the water bath 60 may help cool the shaft 22 by extracting thermal energy from the shaft 22 into the water or other fluid by conduction. In some embodiments, the extrusion system 34 may also include a puller 62 that controls the pulling rate (i.e., the longitudinal advancement rate) of the shaft 22 from the extrusion die 46.

[0025] Referring now to FIG. 2B, an ejector pin 52 is shown, according to some embodiments. In some embodiments, the ejector pin 52 may include a body 64 that includes a generally cylindrical portion 66 and / or a base 68 at a rear end 70 of the body 64 of the ejector pin 52. In some embodiments, the ejector pin 52 may also include a conical portion 72 forward of the cylindrical portion 66, tapering the forward end of the body 64 downward. In some embodiments, the conical portion 72 of the body 64 may taper toward a nose 74. In some embodiments, the body 64 may have a first diameter that tapers to a nose 74 having a second diameter. In some embodiments, the nose 74 may include one or more generally cylindrical portions 76, depending, for example, on the desired number of lumens in the catheter 14. FIG. 2B shows two generally cylindrical portions for forming two lumens in the catheter 14, according to some embodiments. 2A-2B, in some embodiments, nose 74 may extend to the front end 78 of pusher pin 52. The shape of nose 74 and / or pusher pin 52 may vary, for example, according to the desired shape or composition of a particular catheter, as is known in the art.

[0026] In some embodiments, the polymeric material 39 and the reinforcing fibers 28 may flow around the exterior surface of the nose 74 and through the extrusion pins 52. In some embodiments, in response to the polymeric material 39 mixed with the reinforcing fibers 28 flowing around the exterior surface of the nose 74 and through the extrusion pins 52, the reinforcing fibers 28 may be configured to orient toward a position aligned with the central longitudinal axis 31 of the catheter 14. In some embodiments, the polymeric material 39 and the reinforcing fibers 28 exit the extrusion die 46. In some embodiments, in response to pulling and / or withdrawing the polymeric material 39 mixed with the reinforcing fibers 28 from the extrusion die 46, the reinforcing fibers 28 may be configured to further orient toward a position aligned with the central longitudinal axis 31 of the catheter 14.

[0027] 2C-3, a catheter 14 is shown having reinforcing fibers 28 generally aligned with a central longitudinal axis 31 of the catheter 14, according to some embodiments. In some embodiments, the reinforcing fibers 28 may be oriented generally parallel to the central longitudinal axis 31 of the catheter 14, which may increase the stiffness and strength of the catheter 14 and resist kinking. In some embodiments, the distance of one or more reinforcing fibers 28 from the central longitudinal axis 31 of the catheter 14 may vary, such that the depth of the reinforcing fibers 28 within the shaft 22 may vary. As shown in FIG. 3, in some embodiments, a distal end 80 of one or more reinforcing fibers 28 may overlap a proximal end 82 of one or more other reinforcing fibers 28, which may provide strength to the catheter 14.

[0028] 4-6 , in some embodiments, shaft 22 may include walls 26, stripes 84 within walls 26, and reinforcing fibers within stripes 84. In some embodiments, stripes 84 may be electrically conductive, which may provide a path for transmitting and receiving electrical signals through catheter 14. In some embodiments, stripes 84 may be electrically and / or thermally conductive. In some embodiments, each of reinforcing fibers 28 may have a higher tensile strength than walls 26. In some embodiments, each of reinforcing fibers 28 may have a higher tensile strength than stripes 84. In some embodiments, reinforcing fibers 28 may improve the overall tensile strength of catheter 14.

[0029] 4A-4B, in some embodiments, multiple stripes 84 may be spaced around the circumference of shaft 22. In some embodiments, wall 26 may completely surround each of stripes 84. In some embodiments, stripes 84 may extend along all or part of the entire length of catheter 14.

[0030] In some embodiments, wall 26 may include an inner surface that forms lumen 24 and an outer surface that forms the outer diameter and outer diameter of catheter 14. As shown in FIGS. 5A-5B, in some embodiments, stripes 84 may extend entirely through wall 26 from the inner surface to the outer surface. As shown in FIGS. 6A-6B, in some embodiments, stripes 84 may be adjacent to the inner surface and extend partially through (through) wall 26. As also shown in FIGS. 6A-6B, in some embodiments, stripes 84 may be adjacent to the outer surface and extend partially through wall 26. As further shown in FIGS. 6A-6B, in some embodiments, the shaft may include multiple stripes 84.

[0031] 7-9 and 11 , in some embodiments, shaft 22 may include a wall 26, an annular layer 86 within wall 26, and reinforcing fibers 28 within annular layer 86. In some embodiments, annular layer 86 may be electrically conductive, which may provide a path for transmitting and receiving electrical signals through catheter 14. In some embodiments, annular layer 86 may be electrically and / or thermally conductive. In some embodiments, each of reinforcing fibers 28 may have a higher tensile strength than wall 26. In some embodiments, each of reinforcing fibers 28 has a higher tensile strength than annular layer 86.

[0032] In some embodiments, as shown in Figures 7A-7B, shaft 22 may include an annular layer 86 within wall 26, which may sandwich annular layer 86. As shown in Figures 8A-8B, in some embodiments, annular layer 86 may include an inner surface proximate wall 26 and an outer surface that forms the outer diameter and outer diameter of catheter 14. As shown in Figures 9A-9B, in some embodiments, annular layer 86 may include an inner surface that forms lumen 24 and an outer surface proximate wall 26. In some embodiments, annular layer 86 may extend along all or part of the entire length of catheter 14.

[0033] In some embodiments, wall 26 may be composed of a first material, such as a polymeric material 39 (see, e.g., FIG. 2A). In some embodiments, the first material may include a resin, such as, for example, polyurethane. In some embodiments, the resin may provide some degree of torsional resistance. In some embodiments, the first material may include a polyurethane product, such as VIALON™ biomaterial, available from Becton, Dickinson and Company, Franklin Lakes, New Jersey. In some embodiments, the first material may be reinforced with reinforcing fibers 28 to provide additional torsional resistance.

[0034] 4-11 , in some embodiments, the stripe 84 or the annular layer 86 may be composed of a second material, which may be of the same class of material as the first material, to facilitate bonding between the first and second materials during extrusion. In some embodiments, one or more of the reinforcing fibers 28, the stripe 84, and the wall 26 may be radiopaque (which may include barium sulfate or another suitable radiopaque compound) to facilitate visualization of the catheter 14 during a medical procedure. In some embodiments, one or more of the reinforcing fibers 28, the wall 26, the stripe 84, and the annular layer 86 may be biocompatible, allowing for insertion into a patient's blood vessel. In some embodiments, reinforcing fibers 28 composed of a biocompatible material may facilitate one or more of the reinforcing fibers 28 in proximity to a fluid pathway extending through the catheter 14. In some embodiments, when the reinforcing fibers 28, stripes 84, or annular layer 85 are separated from the fluid pathway by the wall 26, a wider range of materials can be used to construct the reinforcing fibers 28, stripes 84, and annular layer 85 when the reinforcing fibers 28, stripes 84, and annular layer 85 are not in contact with the fluid pathway leading to the patient. In some embodiments, the first material or the material of the wall 26 of the catheter 14 may include a conductive additive, which may provide a path for transmitting and receiving electrical signals through the catheter 14. In some embodiments, the reinforcing fibers 28 may include one or more antibacterial, anticoagulant, or antifouling compounds.

[0035] 10 , in some embodiments, the catheter 14 may include multiple lumens 24 extending through the shaft 22. For example, the catheter 14 may include one to five lumens 24, or another suitable number of lumens. In some embodiments, the shaft 22 may include two of the stripes 84. In some embodiments, the stripes 84 may be opposite each other and / or between the lumens 24 and completely surrounded by the wall 26.

[0036] All examples and conditional language described herein are intended for educational purposes to help the reader understand the present invention and the concepts provided by the inventors to facilitate the present technology, and should be construed as not being limited to the specifically recited examples and conditions. Although embodiments of the present invention have been described in detail, it should be understood that various changes, substitutions, and alterations can be made herein without departing from the spirit and scope of the present invention.

Claims

1. 1. A catheter assembly comprising: a catheter adapter having a distal end and a proximal end; a catheter extending from the distal end of the catheter adapter, the catheter including a shaft and a lumen extending through the shaft, the shaft including a wall, a stripe or annular layer within the wall, and a plurality of reinforcing fibers within the stripe or annular layer, each of the plurality of reinforcing fibers having a higher tensile strength than the wall, and each of the plurality of reinforcing fibers having a higher tensile strength than the stripe or annular layer; A catheter assembly comprising:

2. The catheter assembly of claim 1 , wherein the wall comprises an inner surface that defines the lumen and an outer surface that defines an exterior of the catheter.

3. The catheter assembly of claim 2 , wherein the shaft includes the stripe, the stripe being adjacent the inner surface and extending partially through the wall.

4. The catheter assembly of claim 2 , wherein the shaft includes the stripe, the stripe being adjacent the outer surface and extending partially through the wall.

5. The catheter assembly of claim 2 , wherein the shaft includes the stripes, the stripes extending through the wall from the inner surface to the outer surface.

6. 2. The catheter assembly of claim 1, wherein the shaft includes a plurality of stripes spaced around the circumference of the shaft, the plurality of stripes constituting the stripe, and the wall completely surrounds each of the plurality of stripes.

7. 2. The catheter assembly of claim 1, wherein the catheter includes another lumen extending through the shaft, the shaft including the stripe and another stripe, the stripe and the another stripe being on opposite sides of the lumen and completely surrounded by the wall.

8. The catheter assembly of claim 1 , wherein the plurality of reinforcing fibers comprises nylon, aromatic polyamide fibers, or carbon fibers.

9. The catheter assembly of claim 1 , wherein the shaft includes the stripes, and the stripes are electrically conductive.

10. 10. The catheter assembly of claim 1, wherein each of the plurality of reinforcing fibers has a length between 10 microns and 1,000 microns.

11. 2. The catheter assembly of claim 1, wherein each of the plurality of reinforcing fibers has a different distance from the longitudinal axis of the catheter, and wherein a distal end of a particular one of the plurality of reinforcing fibers overlaps a proximal end of another particular one of the plurality of reinforcing fibers.

12. The catheter assembly of claim 1 , wherein the plurality of reinforcing fibers are oriented generally parallel to the longitudinal axis of the catheter.

13. The catheter assembly of claim 1 , wherein the shaft includes the annular layer within the wall, the annular layer including an inner surface that defines the lumen and an outer surface adjacent the wall.

14. The catheter assembly of claim 1 , wherein the shaft includes the annular layer within the wall, the wall sandwiching the annular layer.

15. a catheter adapter having a distal end and a proximal end; a catheter extending from the distal end of the catheter adapter, the catheter including a shaft and a lumen extending through the shaft, the shaft including a wall and a plurality of reinforcing fibers within the wall, each of the plurality of reinforcing fibers having a higher tensile strength than the wall; A catheter assembly comprising:

16. The catheter assembly of claim 13, wherein the plurality of reinforcing fibers comprises nylon, aromatic polyamide fibers, or carbon fibers.

17. The catheter assembly of claim 13 , wherein the plurality of reinforcing fibers are electrically conductive.

18. 14. The catheter assembly of claim 13, wherein each of the plurality of reinforcing fibers has a length between 10 microns and 1,000 microns.

19. The catheter assembly of claim 13 , wherein each of the plurality of reinforcing fibers is encapsulated by the wall.

20. 1. A method of manufacturing a catheter, comprising: providing an extrusion pin in an extrusion die; flowing a polymeric material around an outer surface of the extruder pin and through the extrusion die, the polymeric material including a plurality of reinforcing fibers, the plurality of reinforcing fibers configured to orient toward a position aligned with a longitudinal axis of the catheter in response to the polymeric material flowing around the outer surface of the extruder pin and flowing the polymeric material through the extrusion die; withdrawing the polymeric material from the extrusion die, wherein in response to withdrawing the polymeric material from the extrusion die, the plurality of reinforcing fibers are configured to further orient toward the position aligned with the longitudinal axis of the catheter; A method comprising:

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