A catheter is commonly used to infuse fluids into vasculature of a patient. For example, the catheter may be used for infusing normal saline solution, various medicaments, or total parenteral nutrition. The catheter may also be used for withdrawing blood from the patient.
The catheter may include an over-the-needle peripheral intravenous (“IV”) catheter. In this case, the catheter may be mounted over an introducer needle having a sharp distal tip. The catheter and the introducer needle may be assembled so that the distal tip of the introducer needle extends beyond the distal tip of the catheter with the bevel of the needle facing up away from skin of the patient. The catheter and introducer needle are generally inserted at a shallow angle through the skin into vasculature of the patient.
In order to verify proper placement of the introducer needle and/or the catheter in the blood vessel, a clinician generally confirms that there is “flashback” of blood in a flashback chamber of a catheter assembly that includes the catheter. After placement of the needle has been confirmed, the clinician may remove the needle, leaving the catheter in place for future blood withdrawal or fluid infusion.
Many catheter assemblies have a septum proximal to an extension tube inlet, creating a region distal to the septum that is difficult to flush free of fluids (such as blood or infusates). Stagnant fluid within the region distal to the septum may lead to accumulation of bacteria within the catheter assembly, which may result in infection or removal of the catheter from the patient.
The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in environments such as those described above. Rather, this background is only provided to illustrate one example technology area where some implementations described herein may be practiced.
The present disclosure relates generally to vascular access devices, systems, and methods. More particularly, the present disclosure relates to a catheter assembly having a side port pathway, as well as related devices and methods. In some embodiments, the catheter assembly may include a catheter adapter, which may include a distal end, a proximal end, and an inner surface extending through the distal end and the proximal end. In some embodiments, the inner surface of the catheter adapter may form a lumen. In some embodiments, the catheter adapter may include a side port forming a side port pathway through a sidewall of the catheter adapter and in fluid communication with the lumen.
In some embodiments, the catheter assembly may facilitate flushing of the catheter assembly to avoid stagnant fluid within the catheter assembly. In some embodiments, the side port pathway of the catheter assembly may include one or more features to direct fluid flow and induce turbulent fluid flow within the catheter assembly, which may facilitate flushing. In some embodiments, the features of the side port pathway may facilitate flushing of a region within the catheter assembly that may otherwise be difficult to flush free of fluids (such as blood or infusates). In some embodiments, the region may be disposed distal to the septum. Stagnant fluid within the region distal to the septum may lead to accumulation of bacteria within the catheter assembly, which may result in infection or removal of the catheter from the patient.
In some embodiments, the catheter assembly may include an extension tube integrated within the side port. In some embodiments, a diameter of the side port pathway may increase in a distal direction. In some embodiments, the catheter assembly may include a catheter extending distally from the distal end of the catheter adapter. In some embodiments, the catheter may include a peripheral intravenous catheter, a peripherally-inserted central catheter, or a midline catheter. In some embodiments, the catheter assembly may include a septum, which may be disposed within the lumen proximal to the side port pathway.
In some embodiments, the side port pathway may include a first side and a second side opposite the first side. In some embodiments, the first side may be straight. In some embodiments, a proximal end of the second side may be straight, and a distal end of the second side may be angled proximally with respect to the proximal end of the second side. In some embodiments, the first side may be distal to the second side. In some embodiments, the distal end of the second side may contact the septum.
In some embodiments, the septum may include an elastomeric body surrounded by a canister. In some embodiments, the septum and catheter assembly may not include the canister. In some embodiments, the septum may include a one-piece septum, a two-piece septum, or another suitable septum.
In some embodiments, the side port pathway may include a non-cylindrical portion. In some embodiments, the non-cylindrical portion may include multiple grooves or ribs generally parallel to a central axis of the side port pathway. In some embodiments, the grooves or ribs may be evenly spaced around an inner circumference of the catheter adapter. In some embodiments, the catheter assembly may include the extension tube integrated with the side port. In some embodiments, each of the grooves or ribs may include a proximal end proximate the extension tube. In some embodiments, each of the grooves or ribs may include a distal end proximate the lumen.
In some embodiments, the non-cylindrical portion may include a helical groove. In some embodiments, a distal end of the helical groove may be proximate the septum. In some embodiments, the catheter assembly may include the extension tube integrated with the side port, and a proximal end of the helical groove is proximate the extension tube.
In some embodiments, the non-cylindrical portion may include multiple ridges, which may be generally perpendicular to a central axis of the side port pathway. In some embodiments, the ridges may be evenly spaced apart. In some embodiments, the ridges may be annular.
In some embodiments, the non-cylindrical portion may include a narrowed diameter portion. In some embodiments, the narrowed diameter portion may include a first diameter. In some embodiments, the side port pathway may include a second diameter distal to the first diameter and a third diameter proximal to the first diameter. In some embodiments, the second diameter and the third diameter may be greater than the first diameter. In some embodiments, the non-cylindrical portion may be disposed within the extension tube, which may be disposed within the side port pathway. Thus, in some embodiments, the non-cylindrical portion may be disposed within the side port pathway in this manner. In some embodiments, the extension tube may extend into or through the side port pathway.
In some embodiments, the catheter assembly may include an insert disposed at least partially within the side port pathway and configured to divert fluid flow. In some embodiments, the insert may extend into the lumen from the side port pathway and may include one or more holes. In some embodiments, a distal end of the insert may include a corkscrew shape. In some embodiments, the insert may include a groove extending along a longitudinal axis of the insert. In some embodiments, the insert may be formed by a distal end of the extension tube, which may extend into or through the side port pathway and which may divert fluid flow.
In some embodiments, the insert may include a protrusion on the inner surface of the catheter adapter. In some embodiments, the protrusion may divide the side port pathway into a first fluid pathway extending in a distal direction and a second fluid pathway extending in a proximal direction.
In some embodiments, the catheter assembly may include a fluid diverter disposed between the septum and the catheter and aligned with the side port pathway. In some embodiments, the fluid diverter may include a rotation element, which may include a straight pathway extending therethrough. In some embodiments, the rotation element may be a cylinder or a sphere. In some embodiments, the rotation element may be configured to rotate in response to infusion of fluid from the side port pathway to the lumen. In some embodiments, the fluid diverter may include a pivot element coupled to the inner surface and configured to pivot in response to infusion of fluid from the side port pathway to the lumen.
It is to be understood that both the foregoing general description and the following detailed description are examples and explanatory and are not restrictive of the invention, as claimed. It should be understood that the various embodiments are not limited to the arrangements and instrumentality illustrated in the drawings. It should also be understood that the embodiments may be combined, or that other embodiments may be utilized and that structural changes, unless so claimed, may be made without departing from the scope of the various embodiments of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense.
Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
The present disclosure relates generally to vascular access devices, systems, and methods. More particularly, the present disclosure relates to a catheter assembly, as well as related devices and methods. Referring now to
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In some embodiments, the catheter assembly 30 may include a catheter 47 extending distally from the distal end 34 of the catheter adapter 32. In some embodiments, the catheter 47 may include a peripheral intravenous catheter, a peripherally-inserted central catheter, or a midline catheter. In some embodiments, the catheter assembly 30 may include a wedge 50, which may secure the catheter 47 within the distal end 34 of the catheter adapter 32. In some embodiments, the catheter assembly 30 may include a septum 48, which may be disposed within the lumen 40 proximal to the side port pathway 44.
In some embodiments, the catheter assembly 30 may facilitate flushing of the catheter assembly 30 to avoid stagnant fluid within the catheter assembly 30. In some embodiments, the side port pathway 44 of the catheter assembly 30 may include one or more features to direct fluid flow and induce turbulent fluid flow within the catheter assembly 30, which may facilitate flushing. In some embodiments, the features of the side port pathway 44 may facilitate flushing of a region within the catheter assembly 30 that may otherwise be difficult to flush free of fluids (such as blood or infusates). In some embodiments, the region may be disposed distal and/or proximate to the septum 48. Stagnant fluid within the region distal to the septum 48 may lead to accumulation of bacteria within the catheter assembly 30, which may result in infection or removal of the catheter from the patient. However, the features of the side port pathway 44 may facilitate fluid turbulence within the region, decreasing a likelihood of accumulation of bacteria. In some embodiments, the catheter assembly 30 may reduce build-up of blood on the inner surface 38 and/or reduce interactions of incompatible fluids.
In some embodiments, the catheter assembly may include an extension tube 52 integrated within the side port 42. In some embodiments, the side port pathway 44 may be used for fluid infusion and/or blood collection. In some embodiments, a proximal end of the extension tube 52 may be coupled to a blood collection device.
In some embodiments, a diameter of the side port pathway 44 may increase in a distal direction. For example, a proximal portion of the side port pathway 44 may include a first diameter 54, and a distal portion of the side port pathway 44 may include a second diameter 56, which may be greater than the first diameter 54.
In some embodiments, the side port pathway 44 may include a first side 58 and a second side 60 opposite the first side 58. In some embodiments, the first side 58 may be straight or a have a linear cross-section, as illustrated, for example, in
In some embodiments, the septum 48 may include an elastomeric body surrounded by a canister 66. In some embodiments, the septum 48 and catheter assembly 30 may not include the canister 66. In some embodiments, the septum 48 may include a one-piece septum, a two-piece septum, or another suitable septum.
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In some embodiments, the helical groove 74 may facilitate flushability by inducing more turbulent fluid flow that increases fluid exchange. In some embodiments, the helical groove 74 may terminate just distal of the septum 48, creating a fluid path to the region difficult to flush. In some embodiments, the side port 42 may be molded with a threaded core pin. In some embodiments, in response to the threaded core pin being screwed or unscrewed during molding, the helical groove 74 may be created.
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In some embodiments, the narrowed diameter portion 82 may be proximate the lumen 38. In some embodiments, the narrowed diameter portion 82 may be asymmetric. For example, the narrowed diameter portion 82 may include a protrusion only on a distal side of the side port pathway 44. In these and other embodiments, the narrowed diameter portion 82 may facilitate turbulence and a rotational flow and deflection toward the septum 48.
In some embodiments, the non-cylindrical portion may be disposed within the extension tube 52, which may be disposed within the side port pathway 44 and/or may extend to the lumen 40. Thus, in some embodiments, the narrowed diameter portion 82 may be disposed within the extension tube 52. In some embodiments, the extension tube 52 may not extend into the lumen 40.
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In some embodiments, a distal end of the insert 90 disposed within the lumen 40 may include the holes 92. In some embodiments, a proximal end 96 of the insert 90 may be adjacent and/or contacting the extension tube 52. In some embodiments, the insert 90 may be tubular or conical. In some embodiments, the insert 90 may include an opening 94 aligned with the central axis of the side port pathway 44 and/or larger than the holes 92 such that a significant portion of the fluid continues in the distal direction. In some embodiments, the term “insert” may refer to an element that is inserted within the catheter adapter 32 and is not monolithically formed with the catheter adapter as a single unit. In some embodiments, the insert 90 may be formed by a distal end of the extension tube 52, which may extend into or through the side port pathway 44 and which may divert fluid flow.
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In some embodiments, the cannula may include a first side hole 102 and a second side hole 104. In some embodiments, the first side hole 102 may be aligned with the opening 100, and the first side hole 102 and the opening 100 may be configured to receive the introducer needle therethrough. In some embodiments, the second side hole 104 may be configured to direct fluid from the side port 42 proximally toward the septum 48 and the region difficult to flush. In some embodiments, the second side hole 104 may be proximal to the first side hole 102. In some embodiments, a proximal end 105 of the insert 98 may be adjacent and/or contacting the extension tube 52.
In some embodiments, the insert 98 may be formed by a distal end of the extension tube 52, which may extend into or through the side port pathway 44 and which may divert fluid flow. Thus, in some embodiments, the insert 98 and the extension tube 52 may be monolithically formed as a single unit.
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In some embodiments, the insert 114 may be advanced through the side port 42 and into the catheter 47 immediately prior to flushing. In some embodiments, during flushing, the groove may direct fluid flow toward the septum 48 and the region otherwise difficult to flush. In some embodiments, after completion of flushing, the insert 114 may be removed from the catheter assembly 30 so as to not interfere with infusion or aspiration.
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All examples and conditional language recited herein are intended for pedagogical objects to aid the reader in understanding the invention and the concepts contributed by the inventor to furthering the art and are to be construed as being without limitation to such specifically recited examples and conditions. Although embodiments of the present inventions have been described in detail, it should be understood that the various changes, substitutions, and alterations could be made hereto without departing from the spirit and scope of the invention.
The present application claims priority to U.S. Provisional Application Ser. No. 63/188,834, entitled “Catheter Assembly Having a Side Port Pathway and Related Methods”, filed May 14, 2021, the entire disclosure of which is hereby incorporated by reference in its entirety.
Number | Date | Country | |
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63188834 | May 2021 | US |