Systems and methods to improve instrument guidance within an intravenous catheter assembly

A catheter assembly and/or an introducer may include one or more features configured to guide a probe and/or a catheter distally through a septum. The catheter assembly may include a catheter adapter and the septum. The catheter adapter may include a distal end, a proximal end, and a lumen extending therebetween. In some embodiments, the septum may be disposed within the lumen. The septum may include a proximal surface that is tapered inwardly in a distal direction such that the proximal surface of the septum is configured to guide the probe and/or the catheter distally through the septum. The catheter assembly may be configured to receive an introducer, which may include an introducer element. A proximal end of the introducer element may include another proximal surface that is tapered inwardly in the distal direction such that the other proximal surface is configured to guide the probe or the catheter distally through the septum.

BACKGROUND OF THE INVENTION

Catheters are commonly used for a variety of infusion therapies. For example, catheters may be used for infusing fluids, such as normal saline solution, various medicaments, and total parenteral nutrition, into a patient. Catheters may also be used for withdrawing blood from the patient.

A common type of catheter is an over-the-needle peripheral intravenous (“IV”) catheter. As its name implies, the over-the-needle 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 the catheter assembly. Once placement of the needle has been confirmed, the clinician may temporarily occlude flow in the vasculature and remove the needle, leaving the catheter in place for future blood withdrawal or fluid infusion.

Blood withdrawal using a peripheral IV catheter may be difficult for several reasons, particularly when an indwelling time of the catheter is more than one day. For example, when the catheter is left inserted in the patient for a prolonged period of time, the catheter may be more susceptible to narrowing, collapse, kinking, blockage by debris (e.g., fibrin or platelet clots), and adhering of a tip of the catheter to the vasculature. Due to this, catheters may often be used for acquiring a blood sample at a time of catheter placement but are much less frequently used for acquiring a blood sample during the catheter dwell period. Therefore, when a blood sample is required, an additional needle stick may be needed to provide vein access for blood collection, which may be painful for the patient and result in higher material costs. Accordingly, there is a need for catheter systems and methods that facilitate placement of blood sample instruments, such as, for example, catheters, and probe instruments in the vasculature of the patient without additional needle sticks.

BRIEF SUMMARY OF THE INVENTION

The present application relates generally to instrument guidance within a catheter system, which may include a peripheral IV catheter system. In some embodiments, the catheter system may include a catheter assembly. In some embodiments, the catheter assembly may include one or more of the following: a catheter, a catheter adapter, a septum housing, and a septum.

In some embodiments, the catheter adapter may include a distal end, a proximal end, and a lumen extending therebetween. In some embodiments, the septum may be disposed within the lumen of the catheter adapter. In some embodiments, the septum may be at least partially disposed within the septum housing and configured to at least substantially seal the lumen of the catheter adapter. In some embodiments, the septum housing may prevent dislodgement or destabilization of the septum, thereby preventing leakage of fluid from the lumen of the catheter adapter.

In some embodiments, the catheter assembly may be part of a closed IV catheter system or a catheter system with an integrated extension tube, such as, for example, the Becton Dickinson NEXIVA™ Closed IV Catheter System, the Becton Dickinson NEXIVA™ DIFFUSICS™ Closed IV Catheter System, or the Becton Dickinson PEGASUS™ Safety Closed IV Catheter System. In these and other embodiments, a proximal end of the catheter adapter may include a first port and a second port. In these and other embodiments, the lumen of the catheter adapter may include a first lumen and/or a second lumen. In some embodiments, the first port may form the first lumen and/or the second port may form the second lumen. In some embodiments, the first and second lumens may join at a common lumen. In some embodiments, the first lumen may be generally aligned with the common lumen and/or the second port may include a side port. In some embodiments, the septum and/or the septum housing may be disposed in the first lumen.

In the closed IV catheter system, an introducer needle may be withdrawn through the catheter adapter after insertion of the catheter into vasculature of a patient. In the closed IV catheter system, when the introducer needle is withdrawn through the catheter adapter, the first lumen, which may correspond to a “needle channel,” may be closed off by the septum from an external environment surrounding the catheter adapter. Thus, the septum may at least substantially seal the first port and prevent fluid from exiting the catheter adapter through the first port. In some embodiments, a fluid pathway of the catheter assembly during fluid infusion and/or blood withdrawal may extend through the second port and not the first port.

In some embodiments, the second lumen of the catheter adapter may be connectable to blood withdrawal or infusion means via an extension tube that may extend from the second port of the catheter adapter. In some embodiments, the septum and/or the septum housing may be disposed proximal to the second port of the catheter adapter. In some embodiments, the catheter assembly may be part of another type of catheter system, such as, for example, a non-integrated catheter system or a catheter system without the integrated extension tube.

In some embodiments, the instrument may include another catheter or a probe. In some embodiments, the instrument may include a variable diameter along a length of the instrument. In some embodiments, the instrument may be guided by one or more features of the catheter system, such as, for example, one or more tapered surfaces, to allow the instrument to access a fluid pathway of the catheter assembly and/or the vasculature of the patient. In some embodiments, one or more features of the catheter system may guide the instrument through the septum to access the fluid pathway. In some embodiments, by accessing the fluid pathway and/or the vasculature through the septum, insertion of the instrument through a long and tortuous path of an integrated extension set may be avoided.

In some embodiments, the septum may include a proximal surface that is tapered inwardly in a distal direction such that the proximal surface is configured to guide an instrument distally through the septum. In some embodiments, the septum may include a cavity. In some embodiments, a distal end of the cavity may include an annular protrusion, which may form the proximal surface of the septum. In some embodiments, the septum may include a slit disposed at or near a center of or within the annular protrusion. In some embodiments, the proximal surface of the septum may include an inner surface of the septum or a surface of the septum disposed towards the slit of the septum.

In some embodiments, the septum housing may include a proximal surface that is tapered inwardly in the distal direction such that the proximal surface of the septum housing is configured to guide the instrument distally through the septum. In some embodiments, the septum housing may include a distal end and a proximal end. In some embodiments, the septum may be disposed at least partially within the distal end of the septum housing. In some embodiments, the proximal end of the septum housing may include the proximal surface of the septum housing. In some embodiments, the septum housing may include a canister.

In some embodiments, the catheter system may include an extension or introducer, which may be configured to introduce the instrument into the catheter assembly. In some embodiments, the introducer may include an introducer element, which may be coupled with the proximal end of the catheter adapter. In some embodiments, a proximal end of the introducer element may include an opening being at least partially formed by a proximal and/or an inner surface. In some embodiments, the inner surface may be tapered inwardly in the distal direction such that the inner surface is configured to guide the instrument distally through the introducer element and into the proximal end of the catheter adapter.

In some embodiments, the proximal end of the introducer element may include a coupling mechanism. In some embodiments, a distal end of the introducer element may include a tube or tubular element. In some embodiments, in response to the introducer being coupled to the catheter adapter via the coupling mechanism, the tube may penetrate the septum and/or extend proximate a proximal face of septum, which may help guide the instrument within the catheter assembly. In some embodiments, a distal end of the tube may be blunt, which may prevent harm to the septum.

In some embodiments, the introducer may include a cover disposed over top or at least partially covering the tube. In some embodiments, the cover may contact the proximal face of the septum. In some embodiments, the cover may be elastomeric. In some embodiments, the cover may include a slit, which may facilitate penetration of the cover by the instrument. In some embodiments, the slit of the cover may be aligned with the slit of the septum. In some embodiments, the cover may include one or more antimicrobial agents. In some embodiments, the cover may be configured to seal the introducer from any fluid leakage through the septum when the septum is closed.

In some embodiments, the introducer may include a sheath or sleeve, which may be coupled to the introducer element. In some embodiments, the sleeve may surround the instrument, which may protect the instrument from the external environment surrounding the introducer. In some embodiments, the instrument may be at least partially disposed within the sleeve. In some embodiments, the instrument may be advanced to a position beyond a distal end of the sleeve when the sleeve is compressed or collapsed in the distal direction. In some embodiments, the introducer may include a grip, which may be coupled to a proximal end of the sleeve. In some embodiments, a clinician may move the grip distally to compress or collapse the sleeve in the distal direction and advance the instrument to the position beyond the distal end of the sleeve. In some embodiments, the coupling mechanism may be coupled to a particular port of the catheter adapter. In some embodiments, the fluid may be prevented by the septum from exiting the catheter adapter via the particular port. In some embodiments, the sleeve may be at least partially disposed in a housing, as will be described in further detail.

DETAILED DESCRIPTION OF THE INVENTION

The presently preferred embodiments of the present invention can be understood by reference to the drawings, wherein like reference numbers indicate identical or functionally similar elements. It will be readily understood that the components of the present invention, as generally described and illustrated in the figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description, as represented in the figures, is not intended to limit the scope of the invention as claimed, but is merely representative of presently preferred embodiments of the invention. Moreover, the Figures may show simplified or partial views, and the dimensions of elements in the Figures may be exaggerated or otherwise not in proportion for clarity.

As used in the present disclosure, the terms “proximal” and “distal” may refer to the direction closer to and away from, respectively, a clinician who would place the catheter system into contact with a patient. Thus, for example, the end of the catheter system first touching the body of the patient would be the distal end, while the opposite end of the catheter system (e.g., the end of the device being manipulated by the clinician) would be the proximal end of the catheter system.

The present application relates generally to instrument guidance within a catheter system, which may include a peripheral IV catheter system. Referring now toFIGS. 1A-1C, in some embodiments, the catheter system may include a catheter assembly10. In some embodiments, the catheter assembly may include one or more of the following: a catheter12, a catheter adapter14, a septum housing16, and a septum18.

In some embodiments, the catheter adapter14may include a distal end, a proximal end, and a lumen20extending therebetween. In some embodiments, the septum18may be disposed within the lumen20of the catheter adapter14. In some embodiments, the septum18may be at least partially disposed within the septum housing16. In some embodiments, the septum housing16may prevent dislodgement or destabilization of the septum18, thereby preventing leakage of fluid from the catheter adapter14. In some embodiments, the septum18and the septum housing16may include or correspond to any of the septa18and septum housings16, respectively, illustrated in any of the other Figures.

In some embodiments, the catheter assembly10may be part of a closed IV catheter system or catheter system with an integrated extension tube, such as, for example, the BD NEXIVA™ Closed IV Catheter System, the BD NEXIVA™ DIFFUSICS™ Closed IV Catheter System, or the Becton Dickinson PEGASUS™ Safety Closed IV Catheter System. In these and other embodiments, a proximal end of the catheter adapter14may include a first port22and a second port24. In these and other embodiments, the lumen20of the catheter adapter14may include a first lumen20aand/or a second lumen20b. In some embodiments, the first port22may form the first lumen20aand/or the second port24may form the second lumen20b. In some embodiments, the first and second lumens20a,20bmay join at a common lumen20c. In some embodiments, the first lumen20amay be generally aligned with the common lumen20cand/or the second port24may include a side port. In some embodiments, the septum18and/or the septum housing16may be disposed in the first lumen20a. In some embodiments, the septum18may be configured to at least substantially seal the first lumen20aof the catheter adapter14.

In the integrated or closed IV catheter system, an introducer needle26may be withdrawn through the catheter adapter14after insertion of the catheter12into the vasculature of a patient. In the integrated or closed IV catheter system, when the introducer needle26is withdrawn through the catheter adapter14, the first lumen20a, which may correspond to a “needle channel,” may be closed off by the septum18from an external environment surrounding the catheter adapter14. Thus, the septum18may prevent fluid from exiting the catheter adapter14through the first port20a. In some embodiments, a fluid pathway of the catheter assembly10during fluid infusion and/or blood withdrawal may extend through the second port20band may not extend through the first port20aand the septum18.

In some embodiments, the second lumen20bof the catheter adapter14may be connectable to blood withdrawal or infusion means via an extension tube28that may extend from the second port20bof the catheter adapter14. In some embodiments, the septum18and/or the septum housing16may be disposed proximal to the second port20bof the catheter adapter14.

It is understood that the catheter assembly10may include any number of ports. For example, the catheter assembly10may include a single port in which the septum18and/or the septum housing16may be disposed. In some embodiments, the catheter assembly10may include the first port20a, the second port20b, and one or more additional ports. In some embodiments, fluid may be prevented by the septum18from exiting the catheter adapter14via a particular port in which the septum18is disposed. In some embodiments, the catheter assembly10may be part of another type of catheter system, such as, for example, a non-integrated catheter system. In some embodiments, the extension tubing28and/or second port20bmay be absent. In these and other embodiments, the fluid pathway of the catheter adapter14may extend through the septum18.

In some embodiments, the septum18may include a slit40. In further detail, in some embodiments the septum18, may be pre-slit prior to insertion of the introducer needle26through the septum18or the slit40may be formed when the introducer needle26is inserted through the septum18. In some embodiments, the introducer needle26may be coupled to a needle hub27, which may include a needle safety mechanism.

Referring now toFIGS. 2A-2C, in some embodiments, an instrument may include another catheter and/or a probe30. An example of the probe30is illustrated inFIGS. 2A-2C. However, the probe30may be replaced with the other catheter, an example of which is illustrated inFIGS. 3A-3B. In some embodiments, the instrument may function as both the probe30and the other catheter. In some embodiments, the instrument may be useful for one or more of the following: diagnostics, blood sampling, monitoring, and one or more other purposes.

In some embodiments, the instrument may be guided by one or more features of the catheter system, such as, for example, one or more tapered surfaces, to allow the instrument to access the fluid pathway of the catheter assembly10and/or the vasculature of the patient. In some embodiments, the one or more features of the catheter system may include lead-in features and/or may guide the instrument through the septum18to access the fluid pathway of the catheter assembly10. In some embodiments, by accessing the fluid pathway and/or the vasculature through the septum18, insertion of the instrument through a long and tortuous path of an integrated extension set may be avoided.

In some embodiments, the other catheter may include a replacement catheter, which may be needleless. In some embodiments, the probe30may include one or more openings31and/or one or more sensors32. In some embodiments, the openings31and/or the sensors32may be disposed towards a distal tip of the probe30. In some embodiments, the openings31may serve as fluid inlets and/or outlets. In some embodiments, the sensors32may measure one or more parameters and/or detect one or more elements related to, for example, diagnostic information, blood chemistry, pressure, flow rate, drug identification, microbes, placement of an implantable stent, in-vein catheter tip stabilization feature, or other device, etc. In some embodiments, the one or more features may facilitate placement of a portion of the probe30that includes the sensors32within the fluid pathway of the catheter assembly10and/or the vasculature of the patient.

In some embodiments, the septum18may be a low-drag septum designed to reduce friction on the instrument passing through the septum18, which may aid in threading the instrument through the septum18. In some embodiments, the septum18may be configured to withstand high pressures within the catheter assembly10. In some embodiments, the septum housing16and/or the septum18may be secured within the catheter adapter14in any number of ways. In some embodiments, the septum housing16may include one or more protrusions34. In some embodiments, the one or more protrusions34may include a lip. In some embodiments, the septum housing16may be secured to an inner wall of the catheter adapter14by one or more of the following: an interference fit between the one or more protrusions34and the inner wall, a snap fit between the one or more protrusions34and the inner wall, bonding between the one or more protrusions34and the inner wall, and threading securing the one or more protrusions34to the inner wall. In some embodiments, the inner wall may include a groove or opening.

In some embodiments, the septum housing16may be resilient, and in response to the one or more protrusions34aligning with the groove or opening, the septum housing16may resiliently move outward to retain the one or more protrusions34within the groove or opening in the snap fit. In further detail, in some embodiments, in response to the septum housing16being inserted into the proximal end of the catheter adapter14, the one or more protrusions34may be biased inwardly and/or in response to the one or more protrusions being further inserted into the proximal end and aligning with the groove or opening, the one or more protrusions34may move resiliently outward such that the one or more protrusions34are retained in the groove or opening.

In some embodiments, the bonding between the septum housing16and the inner wall and/or between the septum18and the inner wall may be disposed at various locations on the inner wall. In some embodiments, one or more of the following: adhesive bonding, chemical bonding, ultrasonic welding, and laser welding, may be disposed on all or some surfaces of the inner wall and/or the septum18that are in contact. Additionally or alternatively, one or more of the following: adhesive bonding, chemical bonding, ultrasonic welding, and laser welding, may be disposed on all or some surfaces of the inner wall and/or the septum housing16that are in contact.

In some embodiments, the septum18and/or the septum housing16may be retained within the catheter adapter14without requiring a mechanical or interference interface with the septum housing16. For example, the proximal end of the catheter adapter14may abut and extend over a portion of a surface area of a proximal face of the septum18and/or the septum housing16, thereby retaining the septum18and/or the septum housing16within the catheter adapter14. Thus, the catheter adapter14may prevent the septum18and/or septum housing16from moving proximally within the catheter adapter14due to a wall at the proximal end of the catheter adapter14that abuts and thereby partially blocks the proximal end of the catheter adapter14.

Referring now toFIGS. 2A-2B, in some embodiments, the septum18may include one or more guiding features that may facilitate guidance of the instrument distally through the septum18. As an example, in some embodiments, the septum18may include an proximal surface that is tapered inwardly in a distal direction such that the proximal surface of the septum18is configured to guide the instrument distally through the septum18. In some embodiments, the proximal surface of the septum18may be funnel-shaped or conical-shaped. In some embodiments, the septum18may include a cavity36. In some embodiments, a distal end of the cavity36may include the proximal surface of the septum18. In some embodiments, a slit40of the septum18may be disposed at or near a center of the proximal surface. In some embodiments, the distal end of the cavity36may include an annular protrusion38, which may form the proximal surface of the septum18. In some embodiments, the slit40may be disposed at or near a center of the annular protrusion38. In some embodiments, the one or more guiding features of the septum18may include ribs, protrusions, grooves, or other guiding features that may facilitate direction of the instrument. In some embodiments, the proximal surface of the septum18may include the one or more guiding features. In some embodiments, guiding the instrument may include contacting the one or more guiding features.

In some embodiments, the one or more guiding features of the septum18may be disposed at a proximal end of the septum18. For example, the proximal surface of the septum18may be disposed at a proximal end of the septum18.FIG. 2Billustrates the proximal surface disposed at the proximal end of the septum and the proximal surface as a funnel-shape41, for example.

Referring now toFIGS. 2C-2D, in some embodiments, the septum housing16may include one or more guiding features that may facilitate guidance of the instrument distally through the septum18and/or the septum housing16. As an example, in some embodiments, the septum housing16may include a proximal surface39that is tapered inwardly in the distal direction such that the proximal surface39is configured to guide the instrument distally through the septum18. In some embodiments, the proximal surface39may be funnel-shaped or conical-shaped. In some embodiments, the septum housing16may include a distal end and a proximal end. In some embodiments, the septum18may be at least partially disposed within the distal end of the septum housing16. In some embodiments, the proximal end of the septum housing16may include the proximal surface39. In some embodiments, the septum housing16may include a canister, as illustrated, for example, inFIG. 2D.

In some embodiments, the one or more guiding features of the septum housing16may include ribs, protrusions, grooves, or other guiding features that may facilitate direction of the instrument. In some embodiments, the proximal surface of the septum housing16may include the guiding features. The proximal surface of the septum18illustrated inFIG. 2Cillustrates the funnel-shape41, as an example proximal surface. In some embodiments, a particular port of the catheter adapter14may include the one or more guiding features of the septum housing16and/or the septum housing16may be integrally formed with the particular port of the catheter adapter14.

Referring now toFIGS. 3A-3B, in some embodiments, the catheter system may include an introducer42, which may be configured to introduce the instrument into the catheter assembly10. In some embodiments, the instrument may include another catheter46, as illustrated, for example, inFIGS. 3A-3B. However, the catheter46may be replaced with the probe30, an example of which is illustrated inFIGS. 2A-2C. In some embodiments, the instrument may function as both the probe30and the other catheter46, including elements of both the probe30and the other catheter46.

In some embodiments, the introducer42may include an introducer element44, which may be coupled with the proximal end of the catheter adapter14. In some embodiments, the introducer element44may include one or more guiding features that may facilitate guidance of the instrument distally through the septum. As an example, in some embodiments, a proximal end of the introducer element44may include an opening48at least partially formed by a proximal and/or inner surface57, which may be tapered inwardly in the distal direction such that the inner surface57is configured to guide the instrument distally through the introducer element44and through the slit40of the septum18. In some embodiments, the inner surface57may be conical-shaped or funnel-shaped, as illustrated, for example, inFIG. 3A. In some embodiments, the inner surface57may include one or more ribs, protrusions, grooves, or other guiding features that may facilitate direction of the instrument.

In some embodiments, the introducer element44may include one or more coupling mechanisms that may facilitate coupling between the proximal end of the catheter adapter14and the introducer element44, which may prevent fluid leakage and/or contamination of the fluid pathway when the instrument is inserted within the catheter assembly14. In further detail, in some embodiments, the introducer element44may be coupled with the proximal end of the catheter adapter14in any number of ways, such as, for example, snap-fit, threads, press-fit, interference-fit, or another suitable means. In some embodiments, a particular coupling mechanism of the introducer element44may be coupled to a particular port of the catheter adapter. As illustrated inFIGS. 3A-3B, in some embodiments, one or more protrusions may snap into one or more recesses of the catheter adapter14.

In some embodiments, the catheter adapter14and/or the introducer element44may be monolithically formed as a single piece. In some embodiments, the instrument may be coupled with the introducer element44. In other embodiments, the instrument may not be coupled with the introducer element44.

In some embodiments, the introducer42may include a sheath or sleeve50, which may be coupled to the introducer element44. In some embodiments, the sleeve50may surround the instrument. In these and other embodiments, the sleeve50may shield the instrument from contaminants and/or isolate any blood or other fluids that may remain on the instrument after accessing the fluid pathway of the catheter assembly10. In these and other embodiments, the sleeve50may protect the instrument from the external environment surrounding the introducer42.

In some embodiments, the instrument may be at least partially disposed within the sleeve50. In some embodiments, the sleeve50may constructed of a flexible and/or compliant material. In some embodiments, the sleeve50may be axially-collapsible or axially-compressible. In further detail, in some embodiments, the instrument may be advanced to a position beyond a distal end of the sleeve50when the sleeve is collapsed or compressed in the distal direction. In some embodiments, the introducer42may include a handle or grip52, which may be coupled to a proximal end of the sleeve50. In some embodiments, the clinician may move the grip52distally to collapse or compress the sleeve50in the distal direction and advance the instrument to the position beyond the distal end of the sleeve50.

In some embodiments, various types of sleeves50may be used. In some embodiments, the introducer42may include a housing (not illustrated), which may be coupled with the introducer element44. In some embodiments, the housing may include one or more components, such as, for example, concentric barrels. In some embodiments, at least a portion of the housing may be axially-collapsible or axially-compressible. For example, a first concentric barrel may be advanced into a second concentric barrel.

In some embodiments, the sleeve50may be at least partially disposed within the housing, which may be rigid or semi-rigid. An example housing is described in U.S. Provisional Patent Application. No. 62/534,552, filed Jul. 19, 2017, entitled “Extension Housing a Probe or Intravenous Catheter,” which is hereby incorporated by reference in its entirety. In some embodiments, the housing may include a slot. In some embodiments, a tab or an adapter may be coupled with the proximal end of the instrument or near the proximal end of the instrument. In some embodiments, the tab or the adapter may be configured to move along the slot from a proximal position to a distal position. In some embodiments, in response to movement of the adapter from the proximal position to the distal position, the instrument may be advanced beyond the distal end of the sleeve50and/or the housing. In some embodiments, the adapter may include a cavity configured to receive a syringe or blood collection tube and/or a cannula configured to puncture a septum of the syringe and/or the blood collection tube. An example slot and example adapter is described in U.S. Provisional Patent Application. No. 62/534,552, filed Jul. 19, 2017, entitled “Extension Housing a Probe or Intravenous Catheter.”

As mentioned, in some embodiments, at least a portion of the housing may be axially-collapsible or axially-compressible. For example, the housing may include one or more collapsing and/or telescoping barrels. Additionally or alternatively, the housing may include the slot. In some embodiments, a first concentric barrel may be advanced into a second concentric barrel. In some embodiments, at least a portion of the first concentric barrel and/or the second concentric barrel may be collapsible.

In some embodiments, the introducer42may not include the sleeve50and/or the grip52. In these and other embodiments, the introducer element44may have an extended length such that a portion of the introducer element44protrudes from underneath a dressing used to cover an insertion site of the catheter12, facilitating easy access to the septum18and/or supporting the instrument.

In some embodiments, the introducer element44, the grip52, or another portion of the introducer42may be connected to a luer fitting, Becton Dickinson LUER-LOK™ Access Device, or another device for blood collection and/or monitoring. In some embodiments, a fluid pathway of the introducer42may extend through the grip52. In some embodiments, the introducer element44, the grip52, or another portion of the introducer42may be connected to a monitoring interface and/or monitoring equipment.

Referring now toFIG. 3C, in some embodiments, the introducer element44may include a coupling mechanism. In some embodiments, a proximal end of the introducer element44may include the coupling mechanism. In some embodiments, a distal end of the introducer element may include a tube54. In some embodiments, the coupling mechanism may be disposed proximal to the tube54. In some embodiments, in response to the introducer42being coupled to the catheter adapter14via the coupling mechanism of the introducer element44, the tube54may be disposed within the cavity36and/or proximate a proximal face of the septum18. In these and other embodiments, the tube54may not penetrate the septum18. In these and other embodiments, the tube54may contact the proximal face of the septum18proximate the slit40. In some embodiments, the proximal face may be disposed within the cavity36, although in some embodiments, the septum18may not include the cavity36and/or first and second proximally-extending arms forming the cavity36. In some embodiments, a width of the tube54may be approximately equal to a width of the cavity36. In some embodiments, a distal end of the tube54may be blunt, which may prevent harm to the septum18. In some embodiments, the tube54may extend from a base56portion of the introducer element44.FIG. 3Cillustrates the probe30, which may be replaced with the other catheter46, as previously mentioned.

Referring now toFIG. 3D, in some embodiments, the introducer element44may include a fluid seal, which may prevent fluid from entering a distal opening of the tube54. For example, the introducer element44may include a cover58, which may be configured to be penetrated by the instrument and provide a seal between the septum18and the introducer element44. In some embodiments, the cover58disposed over top or at least partially covering the tube54. In some embodiments, the cover58may cover the distal opening of the tube54. In some embodiments, the cover58may be elastomeric and compliant. In some embodiments, the cover58may include a slit60, which may facilitate penetration of the cover58by the instrument. In some embodiments, the cover58may include one or more antimicrobial agents. In some embodiments, the cover58may facilitate a fluid seal against the proximal face of the septum18.

In some embodiments, the introducer42may include at least one valve59, which may provide a seal that is penetrated by the instrument. In some embodiments, the valve59may include a slit. The valve59of the introducer42may be disposed at any number of locations to prevent fluid from the catheter assembly10from entering all or a portion of the introducer42and/or exiting the proximal end of the introducer. An example valve59is illustrated inFIG. 3D. In some embodiments, the introducer42may include the valve59and/or the cover58. In some embodiments, when the introducer42does not penetrate the septum18, such as, for example, inFIG. 3C, the introducer42may not include the valve59and/or the cover58.

In some embodiments, any of the components of the catheter system, including any component of the introducer42and/or any component of the catheter assembly10, for example, may include one or more antimicrobial agents, such as for example, an antimicrobial coating antimicrobial lubricant, etc. In some embodiments, the antimicrobial agents may reduce a risk of contamination of a fluid pathway of the catheter system.

Referring now toFIGS. 4A-4B, in some embodiments, in response to the introducer42being coupled to the catheter adapter14via the coupling mechanism of the introducer element44, the tube54may penetrate the septum18. In these and other embodiments, fluid within the cavity36of the septum18may be reduced and/or a compressive axial load on the instrument may be decreased compared to when the instrument itself opens the septum18. In some embodiments, a distal end of the tube54may be blunt, which may prevent harm to the septum18. In some embodiments, the introducer42ofFIGS. 4A-4Bmay include one or more of the sleeve50, the grip52, and one or more other components discussed with respect toFIGS. 1-3.FIG. 4illustrates the catheter46prior to insertion within the introducer44, according to some embodiments.

Another example valve59is illustrated inFIG. 4B. In some embodiments, the valve59may be disposed within a needleless connector. In some embodiments, the needleless connector may form a proximal end of the introducer element44. In some embodiments, the valve59may be disposed within the catheter adapter14distal to the septum18. In these embodiments, the tube54may penetrate the septum18but not the valve59, which may be penetrated by the instrument. In some embodiments, the valve59may provide less resistance to the instrument than the septum18.

Referring now toFIG. 5, as explained previously, in some embodiments, the introducer element44may be coupled with the proximal end of the catheter adapter14via any number of coupling mechanisms. For example, the introducer element44may be coupled with the proximal end of the catheter adapter via a snap-fit, threads, a press-fit, an interference-fit, etc. In some embodiments, the introducer44may include a connector62, which may include the one or more coupling mechanisms, such as, for example, threads, as illustrated inFIG. 5. In some embodiments, the connector62may be coupled to the proximal end of catheter adapter14via the one or more coupling mechanisms. In some embodiments, the connector62may be removable from the introducer element44and/or the catheter adapter14. In other embodiments, the connector62may be non-removable from or permanently coupled to the introducer element44and/or the catheter adapter14.FIG. 5illustrates the introducer element44coupled with the sleeve50, according to some embodiments.