Patent Description:
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.

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.

<CIT>, <CIT>, <CIT>, <CIT> and <CIT> each disclose prior art with regard to the subject matter of independent claim <NUM>.

The subject matter of the invention is defined by the appended claims.

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.

In order that the manner in which the above-recited and other features and advantages of the invention are obtained will be readily understood, a more particular description of the invention briefly described above will be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings. These drawings depict only typical embodiments of the invention and are not therefore to be considered to limit the scope 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 to <FIG>, in some embodiments, the catheter system may include a catheter assembly <NUM>. In some embodiments, the catheter assembly may include one or more of the following: a catheter <NUM>, a catheter adapter <NUM>, a septum housing <NUM>, and a septum <NUM>.

In some embodiments, the catheter adapter <NUM> may include a distal end, a proximal end, and a lumen <NUM> extending therebetween. In some embodiments, the septum <NUM> may be disposed within the lumen <NUM> of the catheter adapter <NUM>. In some embodiments, the septum <NUM> may be at least partially disposed within the septum housing <NUM>. In some embodiments, the septum housing <NUM> may prevent dislodgement or destabilization of the septum <NUM>, thereby preventing leakage of fluid from the catheter adapter <NUM>. In some embodiments, the septum <NUM> and the septum housing <NUM> may include or correspond to any of the septa <NUM> and septum housings <NUM>, respectively, illustrated in any of the other Figures.

In some embodiments, the catheter assembly <NUM> may 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 adapter <NUM> may include a first port <NUM> and a second port <NUM>. In these and other embodiments, the lumen <NUM> of the catheter adapter <NUM> may include a first lumen 20a and/or a second lumen 20b. In some embodiments, the first port <NUM> may form the first lumen 20a and/or the second port <NUM> may form the second lumen 20b. In some embodiments, the first and second lumens 20a,20b may join at a common lumen 20c. In some embodiments, the first lumen 20a may be generally aligned with the common lumen 20c and/or the second port <NUM> may include a side port. In some embodiments, the septum <NUM> and/or the septum housing <NUM> may be disposed in the first lumen 20a. In some embodiments, the septum <NUM> may be configured to at least substantially seal the first lumen 20a of the catheter adapter <NUM>.

In the integrated or closed IV catheter system, an introducer needle <NUM> may be withdrawn through the catheter adapter <NUM> after insertion of the catheter <NUM> into the vasculature of a patient. In the integrated or closed IV catheter system, when the introducer needle <NUM> is withdrawn through the catheter adapter <NUM>, the first lumen 20a, which may correspond to a "needle channel," may be closed off by the septum <NUM> from an external environment surrounding the catheter adapter <NUM>. Thus, the septum <NUM> may prevent fluid from exiting the catheter adapter <NUM> through the first port 20a. In some embodiments, a fluid pathway of the catheter assembly <NUM> during fluid infusion and/or blood withdrawal may extend through the second port 20b and may not extend through the first port 20a and the septum <NUM>.

In some embodiments, the second lumen 20b of the catheter adapter <NUM> may be connectable to blood withdrawal or infusion means via an extension tube <NUM> that may extend from the second port 20b of the catheter adapter <NUM>. In some embodiments, the septum <NUM> and/or the septum housing <NUM> may be disposed proximal to the second port 20b of the catheter adapter <NUM>.

It is understood that the catheter assembly <NUM> may include any number of ports. For example, the catheter assembly <NUM> may include a single port in which the septum <NUM> and/or the septum housing <NUM> may be disposed. In some embodiments, the catheter assembly <NUM> may include the first port 20a, the second port 20b, and one or more additional ports. In some embodiments, fluid may be prevented by the septum <NUM> from exiting the catheter adapter <NUM> via a particular port in which the septum <NUM> is disposed. In some embodiments, the catheter assembly <NUM> may be part of another type of catheter system, such as, for example, a non-integrated catheter system. In some embodiments, the extension tubing <NUM> and/or second port 20b may be absent. In these and other embodiments, the fluid pathway of the catheter adapter <NUM> may extend through the septum <NUM>.

In some embodiments, the septum <NUM> may include a slit <NUM>. In further detail, in some embodiments the septum <NUM>, may be pre-slit prior to insertion of the introducer needle <NUM> through the septum <NUM> or the slit <NUM> may be formed when the introducer needle <NUM> is inserted through the septum <NUM>. In some embodiments, the introducer needle <NUM> may be coupled to a needle hub <NUM>, which may include a needle safety mechanism.

Referring now to <FIG>, in some embodiments, an instrument may include another catheter and/or a probe <NUM>. An example of the probe <NUM> is illustrated in <FIG>. However, the probe <NUM> may be replaced with the other catheter, an example of which is illustrated in <FIG>. In some embodiments, the instrument may function as both the probe <NUM> and 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 assembly <NUM> and/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 septum <NUM> to access the fluid pathway of the catheter assembly <NUM>. In some embodiments, by accessing the fluid pathway and/or the vasculature through the septum <NUM>, 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 probe <NUM> may include one or more openings <NUM> and/or one or more sensors <NUM>. In some embodiments, the openings <NUM> and/or the sensors <NUM> may be disposed towards a distal tip of the probe <NUM>. In some embodiments, the openings <NUM> may serve as fluid inlets and/or outlets. In some embodiments, the sensors <NUM> may 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 probe <NUM> that includes the sensors <NUM> within the fluid pathway of the catheter assembly <NUM> and/or the vasculature of the patient.

In some embodiments, the septum <NUM> may be a low-drag septum designed to reduce friction on the instrument passing through the septum <NUM>, which may aid in threading the instrument through the septum <NUM>. In some embodiments, the septum <NUM> may be configured to withstand high pressures within the catheter assembly <NUM>. In some embodiments, the septum housing <NUM> and/or the septum <NUM> may be secured within the catheter adapter <NUM> in any number of ways. In some embodiments, the septum housing <NUM> may include one or more protrusions <NUM>. In some embodiments, the one or more protrusions <NUM> may include a lip. In some embodiments, the septum housing <NUM> may be secured to an inner wall of the catheter adapter <NUM> by one or more of the following: an interference fit between the one or more protrusions <NUM> and the inner wall, a snap fit between the one or more protrusions <NUM> and the inner wall, bonding between the one or more protrusions <NUM> and the inner wall, and threading securing the one or more protrusions <NUM> to the inner wall. In some embodiments, the inner wall may include a groove or opening.

In some embodiments, the septum housing <NUM> may be resilient, and in response to the one or more protrusions <NUM> aligning with the groove or opening, the septum housing <NUM> may resiliently move outward to retain the one or more protrusions <NUM> within the groove or opening in the snap fit. In further detail, in some embodiments, in response to the septum housing <NUM> being inserted into the proximal end of the catheter adapter <NUM>, the one or more protrusions <NUM> may 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 protrusions <NUM> may move resiliently outward such that the one or more protrusions <NUM> are retained in the groove or opening.

In some embodiments, the bonding between the septum housing <NUM> and the inner wall and/or between the septum <NUM> and 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 septum <NUM> that 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 housing <NUM> that are in contact.

In some embodiments, the septum <NUM> and/or the septum housing <NUM> may be retained within the catheter adapter <NUM> without requiring a mechanical or interference interface with the septum housing <NUM>. For example, the proximal end of the catheter adapter <NUM> may abut and extend over a portion of a surface area of a proximal face of the septum <NUM> and/or the septum housing <NUM>, thereby retaining the septum <NUM> and/or the septum housing <NUM> within the catheter adapter <NUM>. Thus, the catheter adapter <NUM> may prevent the septum <NUM> and/or septum housing <NUM> from moving proximally within the catheter adapter <NUM> due to a wall at the proximal end of the catheter adapter <NUM> that abuts and thereby partially blocks the proximal end of the catheter adapter <NUM>.

Referring now to <FIG>, in some embodiments, the septum <NUM> may include one or more guiding features that may facilitate guidance of the instrument distally through the septum <NUM>. As an example, in some embodiments, the septum <NUM> may include an proximal surface that is tapered inwardly in a distal direction such that the proximal surface of the septum <NUM> is configured to guide the instrument distally through the septum <NUM>. In some embodiments, the proximal surface of the septum <NUM> may be funnel-shaped or conical-shaped. In some embodiments, the septum <NUM> may include a cavity <NUM>. In some embodiments, a distal end of the cavity <NUM> may include the proximal surface of the septum <NUM>. In some embodiments, a slit <NUM> of the septum <NUM> may be disposed at or near a center of the proximal surface. In some embodiments, the distal end of the cavity <NUM> may include an annular protrusion <NUM>, which may form the proximal surface of the septum <NUM>. In some embodiments, the slit <NUM> may be disposed at or near a center of the annular protrusion <NUM>. In some embodiments, the one or more guiding features of the septum <NUM> may include ribs, protrusions, grooves, or other guiding features that may facilitate direction of the instrument. In some embodiments, the proximal surface of the septum <NUM> may 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 septum <NUM> may be disposed at a proximal end of the septum <NUM>. For example, the proximal surface of the septum <NUM> may be disposed at a proximal end of the septum <NUM>. <FIG> illustrates the proximal surface disposed at the proximal end of the septum and the proximal surface as a funnel-shape <NUM>, for example.

Referring now to <FIG>, in some embodiments, the septum housing <NUM> may include one or more guiding features that may facilitate guidance of the instrument distally through the septum <NUM> and/or the septum housing <NUM>. As an example, in some embodiments, the septum housing <NUM> may include a proximal surface <NUM> that is tapered inwardly in the distal direction such that the proximal surface <NUM> is configured to guide the instrument distally through the septum <NUM>. In some embodiments, the proximal surface <NUM> may be funnel-shaped or conical-shaped. In some embodiments, the septum housing <NUM> may include a distal end and a proximal end. In some embodiments, the septum <NUM> may be at least partially disposed within the distal end of the septum housing <NUM>. In some embodiments, the proximal end of the septum housing <NUM> may include the proximal surface <NUM>. In some embodiments, the septum housing <NUM> may include a canister, as illustrated, for example, in <FIG>.

In some embodiments, the one or more guiding features of the septum housing <NUM> may include ribs, protrusions, grooves, or other guiding features that may facilitate direction of the instrument. In some embodiments, the proximal surface of the septum housing <NUM> may include the guiding features. The proximal surface of the septum <NUM> illustrated in <FIG> illustrates the funnel-shape <NUM>, as an example proximal surface. In some embodiments, a particular port of the catheter adapter <NUM> may include the one or more guiding features of the septum housing <NUM> and/or the septum housing <NUM> may be integrally formed with the particular port of the catheter adapter <NUM>.

Referring now to <FIG>, in some embodiments, the catheter system may include an introducer <NUM>, which may be configured to introduce the instrument into the catheter assembly <NUM>. In some embodiments, the instrument may include another catheter <NUM>, as illustrated, for example, in <FIG>. However, the catheter <NUM> may be replaced with the probe <NUM>, an example of which is illustrated in <FIG>. In some embodiments, the instrument may function as both the probe <NUM> and the other catheter <NUM>, including elements of both the probe <NUM> and the other catheter <NUM>.

In some embodiments, the introducer <NUM> may include an introducer element <NUM>, which may be coupled with the proximal end of the catheter adapter <NUM>. In some embodiments, the introducer element <NUM> may 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 element <NUM> may include an opening <NUM> at least partially formed by a proximal and/or inner surface <NUM>, which may be tapered inwardly in the distal direction such that the inner surface <NUM> is configured to guide the instrument distally through the introducer element <NUM> and through the slit <NUM> of the septum <NUM>. In some embodiments, the inner surface <NUM> may be conical-shaped or funnel-shaped, as illustrated, for example, in <FIG>. In some embodiments, the inner surface <NUM> may include one or more ribs, protrusions, grooves, or other guiding features that may facilitate direction of the instrument.

In some embodiments, the introducer element <NUM> may include one or more coupling mechanisms that may facilitate coupling between the proximal end of the catheter adapter <NUM> and the introducer element <NUM>, which may prevent fluid leakage and/or contamination of the fluid pathway when the instrument is inserted within the catheter assembly <NUM>. In further detail, in some embodiments, the introducer element <NUM> may be coupled with the proximal end of the catheter adapter <NUM> in 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 element <NUM> may be coupled to a particular port of the catheter adapter. As illustrated in <FIG>, in some embodiments, one or more protrusions may snap into one or more recesses of the catheter adapter <NUM>.

In some embodiments, the catheter adapter <NUM> and/or the introducer element <NUM> may be monolithically formed as a single piece. In some embodiments, the instrument may be coupled with the introducer element <NUM>. In other embodiments, the instrument may not be coupled with the introducer element <NUM>.

In some embodiments, the introducer <NUM> may include a sheath or sleeve <NUM>, which may be coupled to the introducer element <NUM>. In some embodiments, the sleeve <NUM> may surround the instrument. In these and other embodiments, the sleeve <NUM> may 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 assembly <NUM>. In these and other embodiments, the sleeve <NUM> may protect the instrument from the external environment surrounding the introducer <NUM>.

In some embodiments, the instrument may be at least partially disposed within the sleeve <NUM>. In some embodiments, the sleeve <NUM> may constructed of a flexible and/or compliant material. In some embodiments, the sleeve <NUM> may 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 sleeve <NUM> when the sleeve is collapsed or compressed in the distal direction. In some embodiments, the introducer <NUM> may include a handle or grip <NUM>, which may be coupled to a proximal end of the sleeve <NUM>. In some embodiments, the clinician may move the grip <NUM> distally to collapse or compress the sleeve <NUM> in the distal direction and advance the instrument to the position beyond the distal end of the sleeve <NUM>.

In some embodiments, various types of sleeves <NUM> may be used. In some embodiments, the introducer <NUM> may include a housing (not illustrated), which may be coupled with the introducer element <NUM>. 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 sleeve <NUM> may be at least partially disposed within the housing, which may be rigid or semi-rigid. An example housing is described in <CIT>, entitled "Extension Housing a Probe or Intravenous Catheter,". 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 sleeve <NUM> and/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 <CIT>, 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 introducer <NUM> may not include the sleeve <NUM> and/or the grip <NUM>. In these and other embodiments, the introducer element <NUM> may have an extended length such that a portion of the introducer element <NUM> protrudes from underneath a dressing used to cover an insertion site of the catheter <NUM>, facilitating easy access to the septum <NUM> and/or supporting the instrument.

In some embodiments, the introducer element <NUM>, the grip <NUM>, or another portion of the introducer <NUM> may 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 introducer <NUM> may extend through the grip <NUM>. In some embodiments, the introducer element <NUM>, the grip <NUM>, or another portion of the introducer <NUM> may be connected to a monitoring interface and/or monitoring equipment.

Referring now to <FIG>, in some embodiments, the introducer element <NUM> may include a coupling mechanism. In some embodiments, a proximal end of the introducer element <NUM> may include the coupling mechanism. In some embodiments, a distal end of the introducer element may include a tube <NUM>. In some embodiments, the coupling mechanism may be disposed proximal to the tube <NUM>. In some embodiments, in response to the introducer <NUM> being coupled to the catheter adapter <NUM> via the coupling mechanism of the introducer element <NUM>, the tube <NUM> may be disposed within the cavity <NUM> and/or proximate a proximal face of the septum <NUM>. In these and other embodiments, the tube <NUM> may not penetrate the septum <NUM>. In these and other embodiments, the tube <NUM> may contact the proximal face of the septum <NUM> proximate the slit <NUM>. In some embodiments, the proximal face may be disposed within the cavity <NUM>, although in some embodiments, the septum <NUM> may not include the cavity <NUM> and/or first and second proximally-extending arms forming the cavity <NUM>. In some embodiments, a width of the tube <NUM> may be approximately equal to a width of the cavity <NUM>. In some embodiments, a distal end of the tube <NUM> may be blunt, which may prevent harm to the septum <NUM>. In some embodiments, the tube <NUM> may extend from a base <NUM> portion of the introducer element <NUM>. <FIG> illustrates the probe <NUM>, which may be replaced with the other catheter <NUM>, as previously mentioned.

Referring now to <FIG>, in some embodiments, the introducer element <NUM> may include a fluid seal, which may prevent fluid from entering a distal opening of the tube <NUM>. For example, the introducer element <NUM> may include a cover <NUM>, which may be configured to be penetrated by the instrument and provide a seal between the septum <NUM> and the introducer element <NUM>. In some embodiments, the cover <NUM> disposed over top or at least partially covering the tube <NUM>. In some embodiments, the cover <NUM> may cover the distal opening of the tube <NUM>. In some embodiments, the cover <NUM> may be elastomeric and compliant. In some embodiments, the cover <NUM> may include a slit <NUM>, which may facilitate penetration of the cover <NUM> by the instrument. In some embodiments, the cover <NUM> may include one or more antimicrobial agents. In some embodiments, the cover <NUM> may facilitate a fluid seal against the proximal face of the septum <NUM>.

In some embodiments, the introducer <NUM> may include at least one valve <NUM>, which may provide a seal that is penetrated by the instrument. In some embodiments, the valve <NUM> may include a slit. The valve <NUM> of the introducer <NUM> may be disposed at any number of locations to prevent fluid from the catheter assembly <NUM> from entering all or a portion of the introducer <NUM> and/or exiting the proximal end of the introducer. An example valve <NUM> is illustrated in <FIG>. In some embodiments, the introducer <NUM> may include the valve <NUM> and/or the cover <NUM>. In some embodiments, when the introducer <NUM> does not penetrate the septum <NUM>, such as, for example, in <FIG>, the introducer <NUM> may not include the valve <NUM> and/or the cover <NUM>.

In some embodiments, any of the components of the catheter system, including any component of the introducer <NUM> and/or any component of the catheter assembly <NUM>, 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 to <FIG>, in some embodiments, in response to the introducer <NUM> being coupled to the catheter adapter <NUM> via the coupling mechanism of the introducer element <NUM>, the tube <NUM> may penetrate the septum <NUM>. In these and other embodiments, fluid within the cavity <NUM> of the septum <NUM> may be reduced and/or a compressive axial load on the instrument may be decreased compared to when the instrument itself opens the septum <NUM>. In some embodiments, a distal end of the tube <NUM> may be blunt, which may prevent harm to the septum <NUM>. In some embodiments, the introducer <NUM> of <FIG> may include one or more of the sleeve <NUM>, the grip <NUM>, and one or more other components discussed with respect to <FIG>. <FIG> illustrates the catheter <NUM> prior to insertion within the introducer <NUM>, according to some embodiments.

Another example valve <NUM> is illustrated in <FIG>. In some embodiments, the valve <NUM> may be disposed within a needleless connector. In some embodiments, the needleless connector may form a proximal end of the introducer element <NUM>. In some embodiments, the valve <NUM> may be disposed within the catheter adapter <NUM> distal to the septum <NUM>. In these embodiments, the tube <NUM> may penetrate the septum <NUM> but not the valve <NUM>, which may be penetrated by the instrument. In some embodiments, the valve <NUM> may provide less resistance to the instrument than the septum <NUM>.

Referring now to <FIG>, as explained previously, in some embodiments, the introducer element <NUM> may be coupled with the proximal end of the catheter adapter <NUM> via any number of coupling mechanisms. For example, the introducer element <NUM> may 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 introducer <NUM> may include a connector <NUM>, which may include the one or more coupling mechanisms, such as, for example, threads, as illustrated in <FIG>. In some embodiments, the connector <NUM> may be coupled to the proximal end of catheter adapter <NUM> via the one or more coupling mechanisms. In some embodiments, the connector <NUM> may be removable from the introducer element <NUM> and/or the catheter adapter <NUM>. In other embodiments, the connector <NUM> may be non-removable from or permanently coupled to the introducer element <NUM> and/or the catheter adapter <NUM>. <FIG> illustrates the introducer element <NUM> coupled with the sleeve <NUM>, according to some embodiments.

Claim 1:
An introducer (<NUM>), comprising:
an introducer element (<NUM>) configured to be coupled with a proximal end of a catheter adapter (<NUM>), wherein a proximal end of the introducer element (<NUM>) comprises a coupling mechanism configured to couple the introducer element (<NUM>) to a catheter adapter (<NUM>), wherein a distal end of the introducer element (<NUM>) comprises a tube, further comprising an elastomeric cover disposed over top of the tube, wherein a distal end of the tube is blunt, and wherein the elastomeric cover (<NUM>) provides a seal between a septum (<NUM>) and the introducer element;
a sleeve (<NUM>) coupled to the proximal end of the introducer element (<NUM>); and
a grip (<NUM>) coupled to a proximal end of the sleeve (<NUM>), wherein the sleeve (<NUM>) is configured to surround a probe or catheter, wherein the grip (<NUM>) is configured to move distally to compress the sleeve (<NUM>) and advance the probe or the catheter to a position beyond a distal tip of a catheter of the catheter adapter (<NUM>);
characterised in that the introducer comprises a valve (<NUM>) to prevent fluid from entering all or a portion of the introducer and/or exiting the proximal end of the introducer.