Extension for accommodating a probe or an intravenous catheter

Abstract

A vascular access device may include a housing that may include a proximal end, a distal end, and a slot. The distal end of the housing may be configured to couple to a catheter assembly. The vascular access device may further include an instrument disposed within the housing. The instrument may include a catheter or a probe. The instrument may include a proximal end and a distal tip. The proximal end of the instrument may extend through the slot and may be configured to move along the slot to move the instrument from a proximal position to a distal position. In response to movement of the proximal end of the instrument from the proximal position to the distal position, the catheter may advance beyond the distal end of the housing and into the catheter assembly and / or the patient's vascular system.

Description

[0001] This application is a divisional application of a Chinese patent application with Chinese Application No. 201880055649.X, filing date of July 18, 2018, and title of "Extension for Receiving a Probe or an Intravenous Catheter". Technical Field

[0002] The present invention generally relates to the field of medical devices, and more particularly, the present invention relates to an extension. Background Art

[0003] Catheters are commonly used in various infusion therapies. For example, a catheter can be used to infuse fluids such as saline solutions, various drugs, and total parenteral nutrition into a patient. A catheter can also be used to draw blood from a patient.

[0004] A common type of catheter is a stylet-type peripheral intravenous ("IV") catheter. As the name implies, a stylet-type catheter can be mounted on a introducer needle having a sharp distal end. The catheter and the introducer needle can be assembled such that the distal end of the introducer needle extends beyond the distal end of the catheter, and the bevel of the introducer needle faces upward away from the patient's skin. The catheter and the introducer needle are typically inserted through the skin at a shallow angle into the patient's vasculature.

[0005] To verify the proper placement of the introducer needle and / or the catheter in a blood vessel, a clinician typically confirms the "flashback" of blood in the flashback chamber of the catheter assembly. Once the placement of the needle has been confirmed, the clinician can temporarily occlude the flow in the vasculature and remove the needle, leaving the catheter in place for future blood drawing or fluid infusion.

[0006] For several reasons, it can be difficult to draw blood using a peripheral intravenous catheter, especially when the catheter has been in place for more than one day. For example, when a catheter is inserted into a patient for a long time, the catheter may be more likely to narrow, collapse, kink, become blocked by debris (e.g., fibrin or platelet clots), and the catheter tip may become attached to the vasculature. Thus, a catheter is typically available for collecting a blood sample at the time of catheter placement, but is rarely used for collecting a blood sample during catheter retention. Thus, when a blood sample is needed, additional needle sticks are required to provide venous access for blood collection, which can be painful for the patient and result in higher material costs. Accordingly, there is a need for catheter systems and methods that facilitate the placement of blood sampling instruments, such as catheters and probe instruments, in a patient's vasculature without additional needle sticks. Summary of the Invention

[0007] The present application generally relates to extensions or guides that can accommodate instruments such as probes or intravenous catheters, as well as related systems and methods. In some embodiments, the extension can include a vascular access device that allows an instrument to enter a patient's vasculature through another vascular access device (e.g., a catheter assembly), which can be inserted into the patient's vasculature. In some embodiments, when an instrument is introduced into the catheter assembly through the extension, the instrument can enter the fluid path of the catheter assembly and / or the instrument can extend through the catheter assembly and into the patient's vascular system.

[0008] In some embodiments, the extension can include a blood collection device that can be used to obtain a blood sample. In some embodiments, the catheter of a catheter assembly with a significant dwell time may be prone to narrowing, collapsing, kinking, being blocked by debris (e.g., fibrin or platelet clots), and the distal end of the catheter becoming attached to the vascular system. Therefore, it may be difficult to draw blood using the catheter. In some embodiments, the instrument can include another catheter that can be disposed within the extension, and the other catheter can provide access to the patient's vascular system without any additional needling. Thus, in some embodiments, the extension can be used for needleless blood collection and / or fluid infusion. Advantageously, in some embodiments, the extension can also allow for the maintenance of a closed system and aseptic technique while reducing interference or displacement of the catheter and / or catheter securement dressing.

[0009] In some embodiments, the instrument can include a probe that can be disposed within the extension. In some embodiments, the probe can include one or more openings and / or one or more sensors. In some embodiments, the openings and / or sensors can be disposed towards the distal end of the probe. In some embodiments, the openings can serve as fluid inlets and / or fluid outlets. In some embodiments, the sensors can 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, microorganisms, placement of an implantable stent, endovascular catheter tip stabilization characteristics, or other devices, etc. In some embodiments, the extension can facilitate the placement of the sensor-including portion of the probe within the fluid path of the catheter assembly and / or the patient's vascular system. In some embodiments, the instrument can simultaneously act as a probe and another catheter, including elements of both the probe and the other catheter.

[0010] 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 may be secured within the catheter adapter and extend distally from the catheter adapter. In some embodiments, the catheter assembly may include a peripheral intravenous catheter assembly. In some embodiments, the catheter adapter may include a distal end, a proximal end, and a lumen extending between the distal end and the proximal end. 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 displacement or instability of the septum, thereby preventing fluid leakage from the lumen of the catheter adapter.

[0011] In some embodiments, the extension may be coupled to a closed intravenous catheter assembly or a catheter assembly having an integral extension tube, e.g., Becton Dickinson NEXIVA TM Closed intravenous catheter system or Becton Dickinson NEXIVA TM DIFFUSICS TM Closed intravenous catheter system. In these and other embodiments, the 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 lumen and the second lumen may connect 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 within the first lumen.

[0012] In some embodiments, the second lumen of the catheter adapter may be coupled to the extension by an extension tube that may extend from the second port of the catheter adapter, which will be explained in further detail later. In some embodiments, after the catheter is inserted into the patient's vasculature, the introducer needle of the catheter assembly may be withdrawn through the catheter adapter. In a closed intravenous catheter system, when the introducer needle is withdrawn through the catheter adapter, the first lumen, which may correspond to the "needle channel", may be isolated from the external environment around the catheter adapter by the septum. Thus, the septum may at least substantially seal the first port and prevent fluid from leaving the catheter adapter through the first port. In some embodiments, during fluid infusion and / or blood withdrawal, the fluid path of the catheter assembly may extend through the second port but not through the first port. In some embodiments, the septum and / or the septum housing may be disposed proximal to the second port of the catheter adapter.

[0013] In some embodiments, the catheter assembly can include another type of catheter assembly, e.g., a non-integrated catheter assembly or a catheter assembly without an integrated extension tube. In some embodiments, the extension can be coupled to the non-integrated catheter assembly.

[0014] In some embodiments, the extension can include a cannula or housing that can include a proximal end and a distal end. In some embodiments, the distal end of the housing can include a coupling mechanism that can couple the extension to the catheter assembly. In some embodiments, the coupling mechanism can be directly coupled to a catheter adapter. In some embodiments, the proximal end of the extension tube of the catheter assembly can be coupled to an adapter or a coupler element that can be coupled to the extension. In some embodiments, the coupler element can include a Y-adapter, a single port, or a dual port. In some embodiments, the coupler element can include a luer fitting and / or a blood control valve. In some embodiments, the coupler element can include a luer fitting and a removable or non-removable needleless connector.

[0015] In some embodiments, the instrument can be at least partially disposed or housed within the housing. In some embodiments, the housing can at least partially surround the instrument, which can protect the instrument from the external environment around the extension. In some embodiments, the housing can include a slot that can extend parallel to the longitudinal axis of the housing. In these and other embodiments, the housing can be rigid or semi-rigid.

[0016] In some embodiments, the extension can include an adapter that can be coupled to the proximal end of the instrument. In some embodiments, the adapter can be configured to move from a proximal position to a distal position and / or from a distal position to a proximal position along the slot. In some embodiments, in response to movement of the adapter along the slot from the proximal position to the distal position, the instrument advances beyond the distal end of the housing. In some embodiments, in response to movement of the adapter along the slot from the distal position to the proximal position, the instrument can be retracted into the housing. In some embodiments, the distal end of the housing can include an elastomer or other suitable material seal to provide a fluid seal between the distal end of the housing of the extension and the instrument.

[0017] In some embodiments, the adapter can include a cavity configured to receive, for example, a syringe and / or a blood collection tube. In some embodiments, the adapter can include a cannula disposed within the cavity that is configured to pierce a septum of the syringe in response to the syringe advancing into the cavity of the adapter. Additionally or alternatively, in some embodiments, the cannula can be configured to pierce a septum of the blood collection tube in response to the blood collection tube advancing into the cavity of the adapter.

[0018] In some embodiments, the adapter can be coupled to the proximal end of the instrument in any number of ways. In some embodiments, the adapter can be integrally formed with the proximal end of the instrument. In some embodiments, the adapter can be permanently coupled to the proximal end of the instrument, or the adapter can be formed monolithically as a single piece with the proximal end of the instrument. In some embodiments, the adapter can be selectively coupled to the proximal end of the instrument. For example, the proximal end of the instrument can include a luer fitting that can be coupled to a corresponding luer fitting of the adapter. In some embodiments, the luer fitting of the proximal end of the instrument can correspond to the luer fittings of any number of devices. In some embodiments, the proximal end of the instrument can include or can be coupled to an instrument interface, an electrical connector, and / or an optical connector.

[0019] In some embodiments, the instrument can include a proximal end and a distal tip. In some embodiments, the proximal end of the instrument (which can include an instrument seat) can extend through a slot, which can allow a clinician to move the proximal end of the instrument along the slot to move the instrument from a proximal position to a distal position and / or from a distal position to a proximal position. In some embodiments, the proximal end of the instrument can include an instrument seat, which will be explained in further detail later. In some embodiments, the distal position or retracted position of the instrument and / or the adapter can correspond to a position for detecting or collecting blood. In some embodiments, when the instrument is disposed in the proximal position, the proximal end of the instrument can be disposed at or near the proximal end of the slot. In some embodiments, when the instrument is disposed in the distal position, the proximal end of the instrument can be disposed at or near the distal end of the slot.

[0020] In some embodiments, the proximal end of the instrument may include a curved or angled portion that may extend through the slot and / or may be coupled to an adapter or another device. In some embodiments, the adapter may be angled relative to the housing. In some embodiments, the adapter may be oriented parallel to the longitudinal axis of the housing. In some embodiments, the extension may include an advancement tab that may be coupled to the proximal end of the instrument and / or the adapter. In some embodiments, a clinician may pinch or grasp the advancement tab to move the instrument to a proximal position and / or a distal position. In some embodiments, when the adapter is set in the distal position, the instrument advances beyond the distal end of the housing and / or the catheter. In some embodiments, the advancement tab may be offset from the slot, which may facilitate easy movement of the instrument and / or the adapter relative to the slot. In some embodiments, the adapter may serve as the advancement tab.

[0021] In some embodiments, at least a portion of the housing may be axially compressible or axially collapsible. In some embodiments, the extension may include a sheath or sleeve. In some embodiments, the sleeve may at least partially surround the instrument. In these and other embodiments, the sleeve may protect the instrument from contaminants and / or isolate any blood or other fluid that may remain on the instrument after entering the fluid path of the access catheter assembly. In these and other embodiments, the sleeve may protect the instrument from the external environment around the extension.

[0022] In some embodiments, the instrument may be at least partially disposed within the sleeve. In some embodiments, the sleeve may be axially collapsible or axially compressible. More particularly, in some embodiments, when the sleeve collapses or compresses in the distal direction, the instrument may advance to a distal position beyond the distal end of the sleeve.

[0023] In some embodiments, a kit may include one or more of the following: a catheter assembly, an extension, a syringe, a blood collection tube, an alcohol swab, one or more sterile caps, an antimicrobial skin preparation solution, and a catheter securement dressing. In some embodiments, the dressing may include an extension tube slot and / or one or more antimicrobial agents. In some embodiments, the sterile cap may include one or more antimicrobial agents and / or may be configured to enclose a connector element and / or one or more catheter adapter ports. In particular, in some embodiments, the kit may include a blood collection kit, and the instrument may include another catheter. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] To facilitate an understanding of the manner in which the above and other features and advantages of the present invention are obtained, the present invention, which has been briefly described above, will be described in more detail by reference to specific embodiments of the present invention shown in the accompanying drawings. These drawings depict only typical embodiments of the present invention and should not be considered as limiting the scope of the present invention.

[0025] Figure 1A is a top perspective view of an exemplary extension coupled to an exemplary catheter assembly according to some embodiments, showing an exemplary instrument in a proximal position;

[0026] Figure 1B is an extension coupled to a catheter assembly according to some embodiments Figure 1A of a top perspective view, showing the instrument in a distal position;

[0027] Figure 1C is a top perspective view of an exemplary instrument having a variable outer diameter according to some embodiments;

[0028] Figure 2A is according to some embodiments Figure 1A of a top perspective view of an extension, showing an exemplary adapter angled relative to an exemplary housing;

[0029] Figure 2B is a top perspective view of another exemplary extension according to some embodiments, showing an adapter oriented parallel to the longitudinal axis of the housing;

[0030] Figure 2C is a top perspective view of an exemplary Luer connector disposed at the proximal end of an instrument according to some embodiments;

[0031] Figure 2D is according to some embodiments Figure 1A of a top perspective view of an extension, showing an exemplary blood collection tube coupled to an adapter.

[0032] Figure 2E is a top perspective view of an exemplary extension tube coupled to the proximal end of an instrument according to some embodiments;

[0033] Figure 2F is a top perspective view of another exemplary extension tube coupled to the proximal end of an instrument according to some embodiments;

[0034] Figure 2G is a top perspective view of an exemplary marker disposed on an exemplary housing according to some embodiments;

[0035] Figure 2H is a top perspective view of an exemplary sleeve when the instrument is disposed in a proximal position;

[0036] Figure 2I is a top perspective view of the sleeve when the instrument is disposed in the distal position; Figure 2H

[0037] Figure 3 is a top perspective view of another catheter system according to some embodiments, showing another exemplary housing; and

[0038] Figure 4 is a top perspective view of an exemplary kit according to some embodiments. DETAILED DESCRIPTION

[0039] The presently preferred embodiments of the present invention can be understood by reference to the accompanying drawings, wherein like reference numerals indicate identical or functionally similar elements. It will be readily understood that, as generally described and illustrated in the drawings herein, the components of the present invention may be arranged and designed in a wide variety of different configurations. Thus, as shown in the drawings, the following more detailed description is not intended to limit the scope of the claimed invention, but is merely representative of the presently preferred embodiments of the invention. Also, the drawings may show simplified or partial views, and for clarity, the dimensions of the elements in the drawings may be enlarged or otherwise out of proportion.

[0040] As used in the present disclosure, the terms "proximal" and "distal" may refer, respectively, to directions that are closer to and farther from a clinician who positions the catheter system in contact with a patient. Thus, for example, the end of the catheter system that first contacts the patient's body will be the distal end, while the opposite end of the catheter system (e.g., the end of the device manipulated by the clinician) will be the proximal end of the catheter system.

[0041] The present application generally relates to extensions that can accommodate instruments such as probes or intravenous catheters, as well as related systems and methods. Now referring to Figure 1A-1B , in some embodiments, the extension 10 or introducer can be configured to guide the instrument 12 into the catheter assembly 14. In some embodiments, when the instrument 12 is guided into the catheter assembly 14, the instrument 12 can enter the fluid path of the catheter assembly 14 and / or the instrument can extend through the catheter assembly 14 and into the patient's vasculature.

[0042] ​In some embodiments, the extension member 10 can include a blood collection device that can be used to obtain a blood sample. In some embodiments, the catheter 16 of the catheter assembly 14 having a significant dwell time may be prone to narrowing, collapsing, kinking, being blocked by debris (e.g., fibrin or platelet clots), and the distal end 18 of the catheter 16 being attached to the vasculature. Thus, it may be difficult to draw blood using the catheter 16. In some embodiments, the instrument 12 can include another catheter that can be disposed within the extension member and that can provide access to the patient's vasculature without any additional needling, e.g., as Figure 1B shown. Thus, in some embodiments, the extension member 10 can be used for needleless blood collection and / or fluid infusion.

[0043] In some embodiments, the instrument 12 can include a probe that can be at least partially disposed within the extension member 10. In some embodiments, the probe can include one or more openings and / or one or more sensors. In some embodiments, the openings and / or sensors can be disposed toward the distal end of the probe. In some embodiments, the openings can serve as fluid inlets and / or outlets. In some embodiments, the sensors can measure one or more parameters and / or detect one or more elements related to, e.g., diagnostic information, blood chemistry, pressure, flow rate, drug identification, microorganisms, placement of an implantable stent, characteristics of the stability of the intravenous catheter tip, or other devices, etc. In some embodiments, the extension member 10 can facilitate placement of a portion of the probe including the sensors within the fluid path of the catheter assembly 14 and / or within the patient's vasculature. In some embodiments, the instrument 12 can act as both the probe and the other catheter, including elements of both the probe and the other catheter.

[0044] In some embodiments, the catheter assembly 14 can include one or more of the following: the catheter 16, the catheter adapter 20, the septum housing, and the septum. In some embodiments, the catheter 16 can be fixed within the catheter adapter 20 and extend distally from the catheter adapter. In some embodiments, the catheter assembly 14 can include a peripheral intravenous catheter assembly. In some embodiments, the catheter adapter 20 can include a distal end, a proximal end, and a lumen extending between the distal end and the proximal end. In some embodiments, the septum can be disposed within the lumen of the catheter adapter 20. In some embodiments, the septum can 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 can prevent displacement or instability of the septum, thereby preventing fluid leakage from the lumen of the catheter adapter.

[0045] In some embodiments, the extension member 10 may be coupled to a closed intravenous catheter assembly or a catheter assembly having an integral extension tube 22, e.g., Becton Dickinson NEXIVA TM Closed intravenous catheter system or Becton Dickinson NEXIVA TM DIFFUSICS TM Closed intravenous catheter system. In these and other embodiments, the proximal end of the catheter adapter 20 may include a first port 24 and a second port 26. In these and other embodiments, the lumen of the catheter adapter 20 may include a first lumen and / or a second lumen. In some embodiments, the first port 24 may form the first lumen and / or the second port 26 may form the second lumen. In some embodiments, the first lumen and the second lumen may be connected at a common lumen. In some embodiments, the first lumen may be generally aligned with the common lumen, and / or the second port 26 may include a side port. In some embodiments, a septum and / or a septum housing may be disposed in the first lumen 24.

[0046] In some embodiments, the second lumen of the catheter adapter 20 may be coupled to the extension member 10 via an extension tube 22 that may extend from the second port 26 of the catheter adapter 20, which will be explained in further detail later. In some embodiments, after the catheter 16 is inserted into a patient's vasculature, a guidewire needle (not shown) of the catheter assembly 14 may be withdrawn through the catheter adapter 20. In a closed intravenous catheter system, when the guidewire needle is withdrawn through the catheter adapter 20, the first lumen 24 may be isolated from the external environment around the catheter adapter 20 by a septum, and the first lumen may correspond to a "needle channel". Thus, the septum may at least substantially seal the first port 24 and prevent fluid from leaving the catheter adapter 20 through the first port 24. During fluid infusion and / or blood withdrawal, the fluid path of the catheter assembly 14 may extend through the second port 26 and not through the first port 24. In some embodiments, a septum and / or a septum housing may be disposed proximal to the second port 26 of the catheter adapter 20.

[0047] In some embodiments, the catheter assembly 14 may include another type of catheter assembly, e.g., a non-integrated catheter assembly or a catheter assembly without an integral extension tube 22. In some embodiments, the extension member 10 may be coupled to a non-integrated catheter assembly. In some embodiments, the extension member 10 may be directly coupled to a port of a non-integrated catheter assembly. In some embodiments, by passing through a specific septum and / or the first port 24 into the fluid path and / or the vasculature, the insertion of the instrument 12 through the longer path of the extension tube 22 or an integrated extension kit may be avoided.

[0048] In some embodiments, the instrument 12 can be guided by one or more features (e.g., one or more tapered surfaces) to allow the instrument 12 to enter the fluid path of the catheter assembly and / or the patient's vasculature. The operation of guiding the instrument 12 through the catheter assembly 14 is described in further detail in U.S. Patent Application No. 62 / 534,557, filed on July 19, 2017, entitled "Systems and Methods to Improve Instrument Guidance Within an Intravenous Catheter Assembly", which is incorporated herein by reference in its entirety.

[0049] In some embodiments, the extension 10 can include a barrel or housing 28, which can include a proximal end and a distal end. In some embodiments, the distal end of the housing 28 can include a coupling mechanism 30, which can couple the extension 10 to the catheter assembly 14. In some embodiments, the coupling mechanism 30 can be a Luer connector, e.g., a male Luer connector or a Luer lock threaded collar. In some embodiments, the coupling mechanism 30 can include a non-Luer coupling mechanism. In some embodiments, the coupling mechanism 30 can be part of a guide element, as described in further detail in U.S. Patent Application No. 62 / 534,557, filed on July 19, 2017, entitled "Systems and Methods to Improve Instrument Guidance Within an Intravenous Catheter Assembly".

[0050] In some embodiments, the coupling mechanism 30 can be directly coupled to the catheter adapter 20. In some embodiments, the proximal end of the extension tube 22 of the catheter assembly 14 can include an adapter or coupling element 32, which can be coupled to the corresponding coupling mechanism 30 of the extension 10. In some embodiments, the extension tube 22 can provide compliance and / or flexibility in the system, which can allow the length of the extension 10 to be shortened and / or prevent the use of another extension tube, which will be explained in further detail later. In some embodiments, the coupling element 32 can include a Y-type adapter, a single port, or a double port. In some embodiments, the coupling element 32 can include a Luer connector and / or a blood control valve. In some embodiments, the blood control valve can facilitate the maintenance of a closed system and prevent blood leakage.

[0051] In some embodiments, the coupling mechanism 30 can include at least one valve that can provide a fluid seal through which the instrument penetrates. The valve of the coupling mechanism 30 can be disposed at any number of locations to prevent fluid from the catheter assembly 14 from entering all or a portion of one or more of the following: the coupling mechanism 30, the sleeve 55 ( Figure 2H-2I shown in), and the housing 28. In some embodiments, the valve can include a diaphragm and / or a slit. In some embodiments, the valve can cover the distal opening of the coupling mechanism 30. In some embodiments, the valve can be disposed within the lumen of the coupling mechanism 30 and / or extend across the diameter of the lumen.

[0052] In some embodiments, the instrument 12 can be at least partially disposed or housed within the housing 28. In some embodiments, the housing 28 can at least partially surround the instrument, which can protect the instrument 12 from the external environment and / or microorganisms around the extension 10. In some embodiments, the housing 28 can include a slot 34 that can extend parallel to the longitudinal axis of the housing 28. In these and other embodiments, the housing 28 can be rigid or semi-rigid. In some embodiments, the housing 28 can be transparent or opaque.

[0053] In some embodiments, at least a portion of the housing 28 can be axially compressible or axially collapsible. For example, the housing 28 can include one or more collapsible and / or telescoping tubes. Additionally or alternatively, the housing 28 can include a slot 34. In some embodiments, a first concentric tube can be advanced into a second concentric tube. In some embodiments, at least a portion of the first concentric tube and / or the second concentric tube can be collapsible.

[0054] In some embodiments, the extension 10 can include an adapter 36 that can be coupled to the proximal end of the instrument 12. In some embodiments, the adapter 36 can be configured to move from a proximal position to a distal position and / or from a distal position to a proximal position along the slot 34. In some embodiments, in response to the movement of the adapter 36 along the slot 34 from the proximal position to the distal position, the instrument 12 advances beyond the distal end of the housing 28. In some embodiments, in response to the movement of the adapter 36 along the slot 34 from the distal position to the proximal position, the instrument 12 can be retracted into the housing 28.

[0055] In some embodiments, the adapter 36 can include a cavity configured to receive, for example, a syringe and / or a blood collection tube. In some embodiments, the adapter 36 can include a cannula 38 disposed within the cavity that is configured to pierce a septum of the syringe in response to the syringe advancing into the cavity of the adapter 36. Additionally or alternatively, in some embodiments, the cannula 38 can be configured to pierce a septum of the blood collection tube in response to the blood collection tube advancing into the cavity of the adapter 36. In some embodiments, the adapter 36 can correspond to a Becton Dickinson single-use holder or a similar holder.

[0056] In some embodiments, the instrument 12 can include a proximal end and a distal tip 42. In some embodiments, the distal tip 42 can include one or more holes 44, which can be inlet holes and / or outlet holes. In some embodiments, the distal tip 42 can be constructed of a material that is softer and / or more rigid than the proximal end of the instrument 12 to resist warping. In some embodiments, the distal tip 42 can be blunt, straight, or tapered. In some embodiments, the proximal end of the instrument 12 can extend through the slot 34, which can allow a clinician to move the proximal end of the instrument 12 along the slot 34 to move the instrument from a proximal position to a distal position and / or from a distal position to a proximal position.

[0057] Now referring to Figure 1C , in some embodiments, the instrument 12 can include a variable outer diameter. In some embodiments, the outer diameter of the distal portion 41 of the instrument can be less than the outer diameter of the proximal portion 43 of the instrument 12. Additionally or alternatively, the instrument 12 can have a variable stiffness along the length of the instrument 12. In some embodiments, the distal portion 41 can be configured to bend at the transition from the second inner lumen of the catheter adapter 20 to the common lumen, as Figure 1C shown. In these and other embodiments, the proximal portion 43 can be more rigid than the distal portion 41. In some embodiments, the distal portion 41 can be more rigid than the proximal portion 43.

[0058] Now referring to Figure 2A-2F, in some embodiments, the adapter 36 can be coupled to the proximal end of the instrument 12 in any number of ways. In some embodiments, the adapter 36 can be removably or non-removably coupled to the proximal end of the instrument 12. In some embodiments, another extension tube can extend from the proximal end of the instrument 12 to the adapter 36. The adapter 36 can be integrally formed with the proximal end of the instrument 12. In some embodiments, the adapter 36 can be permanently coupled to the proximal end of the instrument 12, or the adapter can be integrally formed as a single piece with the proximal end of the instrument 12. In some embodiments, the adapter 36 can be selectively coupled to the proximal end of the instrument 12. For example, the proximal end of the instrument can include a Luer connector 40, such as Figure 2C shown, and this Luer connector can be coupled to a corresponding Luer connector of the adapter 36. In some embodiments, the Luer connector 40 at the proximal end of the instrument 12 can correspond to and be coupled to the Luer connectors of any number of devices. In some embodiments, the proximal end of the instrument 12 can include an instrument interface, electrical connectors, and / or optical connectors.

[0059] In some embodiments, the proximal end of the instrument 12 can include a bent or angled portion that can extend through the slot 34 and / or can be coupled to the adapter 36 or another device. In some embodiments, another extension tube can extend through the slot 34. In some embodiments, the proximal end of the instrument can include an instrument seat that can facilitate coupling to the adapter. In some embodiments, the instrument seat can include the bent or angled portion and / or can extend through the slot 34. In some embodiments, the instrument seat can be joined to the distal portion of the instrument 12 by mechanical, adhesive, solvent, ultrasonic, or another suitable type of bonding. For clarity, in some embodiments, the proximal end of the instrument 12 can extend through the slot 34 via the instrument seat extending through the slot 34 or another portion of the instrument 12 extending through the slot 34.

[0060] In some embodiments, the adapter 36 can be angled relative to the housing, such as Figure 2A shown. In some embodiments, the adapter 36 can be oriented parallel to the longitudinal axis of the housing 28, such as Figure 2B shown.

[0061] In some embodiments, the extension may include a forward tab 46 that may be coupled to the proximal end of the instrument 12 and / or the adapter 36. In some embodiments, a clinician may pinch or grasp the forward tab 46 to move the instrument 12 to a proximal position and / or a distal position. In some embodiments, when the adapter 36 is in the distal position, the instrument 12 advances beyond the distal end of the housing 28. In some embodiments, the forward tab 36 may be disposed in any number of positions. In some embodiments, the forward tab 46 may be offset from the slot 34, such as as Figure 2A-2E shown, which may facilitate easy movement of the instrument 12 and / or the adapter 36 relative to the slot 34. In some embodiments, the forward tab 46 may be aligned with the slot 34. As an alternative or in addition to the forward tab 46, the extension 10 may include one or more other grasping surfaces. For example, the adapter 36 may include one or more grasping surfaces. Figure 2D A blood collection tube 48 disposed within the cavity of the adapter 36 is shown in accordance with some embodiments.

[0062] Figure 2E The distal end of an extension tube 49 coupled to the proximal end of the instrument 12 is shown in accordance with some embodiments. In some embodiments, the proximal end of the extension tube 49 may be coupled to the adapter 36 or another device. In some embodiments, the proximal end of the extension tube 49 may include a coupling mechanism, such as a luer fitting that may be compatible with the luer fitting of the adapter 36 and / or another device. In some embodiments, the extension tube 49 may be constructed of a flexible material. In some embodiments, the extension tube 49 may facilitate greater compliance and / or flexibility during blood collection, which may reduce interference with the catheter 16 and / or the catheter fixation dressing.

[0063] Now referring to Figure 2F , in some embodiments, the extension tube 49 may extend through the proximal end of the housing 28. In some embodiments, the extension tube 49 may include an extended length. In these and other embodiments, the housing 28 may not include a slot 34. In some embodiments, the extension tube 49 may be moved distally into the housing 28 to move the instrument to a distal position. In some embodiments, the extension tube 49 may be moved proximally away from the housing to retract the instrument to a proximal position. In some embodiments, the extension tube 49 may be rigid or semi-rigid. In some embodiments, the proximal end of the housing 28 may include a stop 51 that may prevent fluid from leaking out of the proximal end of the housing 28. In some embodiments, the extension tube 49 may extend through the stop 51.

[0064] Now referring to Figure 2G, in some embodiments, the housing 28 may include one or more markings 53 or metrics that may visually indicate to the clinician the insertion depth of the instrument 12. In some embodiments, the markings 53 may indicate the distance of insertion and / or retraction of one or more different instruments 12, such as the instruments may include different types of catheters. In some embodiments, the extension 10 may include a locking mechanism that may allow the instrument 12 to be locked in a distal position, a proximal position, or one or more positions between the distal and proximal positions. In some embodiments, the instrument 12 may be selectively locked. In some embodiments, the markings may include stoppers or other features that may permanently or selectively hold the instrument 12. In some embodiments, the markings 53 may indicate one or more of the following: the distal position of the instrument, the proximal position of the instrument, and the position between the distal end and the proximal position of the instrument.

[0065] Now refer to Figure 2H-2I , in some embodiments, the extension 10 may include a sheath or sleeve 55. In some embodiments, the sleeve 55 may at least partially surround the instrument 12. In these and other embodiments, the sleeve 55 may protect the instrument 12 from contaminants and / or may isolate any blood or other fluid that may remain on the instrument 12 after entering the fluid path of the catheter assembly 14. In these and other embodiments, the sleeve 55 may protect the instrument 12 from the external environment around the extension.

[0066] In some embodiments, the sleeve 55 may be axially collapsible or axially compressible. More specifically, in some embodiments, for example, when the sleeve 55 collapses or compresses in the distal direction, the instrument 12 may advance to a distal position beyond the distal end of the sleeve 55 and / or the catheter 16, such as as Figure 2I shown. In some embodiments, the proximal end of the sleeve 55 may be coupled to the instrument. For example, the proximal end of the sleeve 55 may be coupled to the proximal end of the instrument 12. In some embodiments, the distal end of the sleeve 55 may be coupled to the coupling mechanism 30 or another part of the housing 28. In some embodiments, the sleeve 55 may extend through the slot 34 or may not extend through the slot.

[0067] Now refer to Figure 3, in some embodiments, at least a portion of the sleeve 55 may be axially compressible or axially collapsible. More specifically, in some embodiments, when the sleeve 55 is compressed or collapsed in the distal direction, the instrument 12 may be advanced to a position beyond the distal end of the sleeve 55. In some embodiments, the extension 10 may include a seat or a gripping portion 50 that may be coupled to the proximal end of the sleeve 55. In some embodiments, a clinician may move the gripping portion 50 distally to compress or collapse the sleeve 55 in the distal direction and advance the instrument 12 to a position beyond the distal end of the sleeve 55. In some embodiments, a clinician may move the gripping portion 50 proximally to expand the sleeve 55 in the proximal direction and retract the instrument 12 into the sleeve 55, where the instrument 12 may be locked. In some embodiments, the gripping portion 50 and / or the instrument 12 may be coupled to, for example, an adapter 36, another device, an instrument interface, an electrical connector, and / or an optical connector. In some embodiments, as Figure 3 shown, the extension 10 may not include a housing 28.

[0068] Now referring to Figure 4 , in some embodiments, a kit 52 may include one or more of the following: a catheter assembly 14, an extension 10, a syringe 54, a blood collection tube 48, an alcohol swab 56, one or more sterilization caps 58, and a catheter fixation dressing (not shown). In some embodiments, the dressing may include an extension tube slot and / or one or more antimicrobial agents. In some embodiments, the sterilization cap 58 may include one or more antimicrobial agents and / or may be configured to enclose a connector element 32 and / or one or more catheter adapter ports. In particular, in some embodiments, the kit 52 may include a blood collection or line draw kit, and the instrument 12 may include another catheter.

[0069] In some embodiments, a method of using the extension 10 and / or kit 52 can include disinfecting the connector element 32 with an alcohol swab 56. In some embodiments, after disinfecting the connector element 32, the extension 10 can be coupled to the catheter assembly 14 through the connector element 32. In some embodiments, the catheter assembly 14 can have been previously inserted into a patient's vasculature. In some embodiments, the instrument 12 can then be advanced through the fluid path of the catheter assembly 14, and / or the distal end 42 of the instrument can be placed into the vasculature distal to the end 18 of the catheter 16. In some embodiments, after the instrument is advanced, a syringe 54 (which can be pre-filled) can be used to flush the catheter assembly 14 to remove stagnant blood and / or medication. In some embodiments, the plunger of the syringe 54 can be pulled to aspirate a discarded sample. In some embodiments, a blood collection tube 48 can be coupled to the adapter 36 to obtain a blood sample. In some embodiments, after blood collection and / or detection, the extension 10 can be detached from the catheter assembly 14, and a disinfecting cap 58 can be placed on the connector element 32 for disinfection, the disinfecting cap can include one or more antimicrobial agents. In some embodiments, one or more steps of the method can be optional, such as the step of flushing the catheter assembly 14 and / or the step of aspirating a discarded sample. In some embodiments, the extension 10 can be discarded after use.

[0070] Without departing from the structure, method, or other essential features of the invention as broadly described herein and claimed below, the invention may be embodied in other specific forms. The described embodiments are to be considered in all respects only as illustrative and not restrictive. Thus, the scope of the invention is indicated by the appended claims rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims

1. An extension configured to be coupled to a catheter assembly, the extension comprising: A housing including a proximal end, a distal end, and a slot, wherein the slot includes a proximal end and a distal end, and wherein the proximal end of the slot is distal to the proximal end of the housing; and An instrument disposed within the housing, wherein the instrument includes a proximal end and a distal portion forming a blunt distal tip through which blood can be collected, wherein the proximal end of the instrument extends outwardly through the slot to form a blood collection adapter, and the proximal end of the instrument including the blood collection adapter is configured to be movable along the slot from a proximal position distal to the proximal end of the slot to a distal position, wherein the extension is configured such that when the proximal end of the instrument is in the proximal position distal to the proximal end of the slot, the distal tip of the instrument is within the housing, and wherein in response to movement of the proximal end of the instrument from the proximal position to the distal position, the distal tip of the instrument is configured to advance distally of the housing such that blood can be collected directly from a patient's vasculature via the blood collection adapter.

2. The extension according to claim 1, wherein, The blood collection adapter includes a cavity configured to receive a syringe or a blood collection tube, and wherein the blood collection adapter further includes a cannula disposed within the cavity and configured to pierce a septum of the syringe or the blood collection tube in response to advancement of the syringe or the blood collection tube into the cavity of the blood collection adapter.

3. The extension according to claim 1, wherein, The blood collection adapter is angled relative to the housing.

4. The extension according to claim 1, wherein, The blood collection adapter is oriented parallel to the longitudinal axis of the housing.

5. The extension of claim 1, further comprising an advancement tab coupled to the instrument.

6. The extension according to claim 5, wherein The advancement tab is offset from the slot.

7. The extension member according to claim 1, wherein, The outer diameter of the distal portion of the instrument is less than the outer diameter of the proximal portion of the instrument.

8. The extension according to claim 1, wherein, The stiffness of the instrument varies along the length of the instrument.

9. The extension member according to claim 8, wherein, The proximal portion of the instrument is more rigid than the distal portion of the instrument.

10. The extension member according to claim 1, wherein, The instrument includes a probe.

11. The extension according to claim 1, wherein The proximal end of the instrument extends outwardly through the slot.

12. The extension according to claim 1, wherein, The distal end of the housing includes a luer fitting mechanism.

13. The extension according to claim 1, wherein, The instrument includes a catheter.

14. An extension configured to be coupled to a catheter assembly, the extension comprising: A housing including a proximal end and a distal end; An instrument disposed within the housing, wherein the instrument includes a catheter or a probe, and wherein the instrument includes a proximal end and a blunt distal tip through which blood can be collected, and wherein the instrument is configured to be movable relative to the housing from a proximal position to a distal position, and wherein when the instrument is disposed in the distal position, the instrument is advanced beyond the distal end of the housing; and An extension tube, wherein the proximal end of the instrument is coupled to the distal end of the extension tube.

15. The extension member according to claim 14, further comprising an adapter, wherein, The proximal end of the extension tube is coupled to the adapter, wherein the adapter includes a cavity configured to receive a syringe or a blood collection tube, and wherein the adapter further includes a cannula disposed within the cavity and configured to pierce the septum of the syringe or blood collection tube in response to the syringe or blood collection tube being advanced into the cavity of the adapter, and wherein the extension tube extends through the proximal end of the housing.

16. A vascular access system comprising: A catheter assembly including a catheter adapter having: a distal end from which a catheter extends; A first port formed at the proximal end through which a guide needle is selectively coupled to the catheter adapter; And a side port; And An extension including: A housing including a proximal end and a distal end, wherein the distal end of the housing is coupled to the side port; An instrument disposed within the housing, wherein the instrument includes a catheter or a probe, and wherein the instrument includes a proximal end and a blunt distal tip through which blood can be collected, and wherein the instrument is configured to be movable relative to the housing from a proximal position to a distal position, and wherein when the instrument is disposed in the distal position, the instrument is advanced beyond the distal end of the housing; and An extension tube, wherein the proximal end of the instrument is coupled to the distal end of the extension tube.

17. The vascular access system according to claim 16, further comprising an adapter, wherein, The proximal end of the extension tube is coupled to the adapter, wherein the adapter includes a cavity configured to receive a syringe or a blood collection tube, and wherein the adapter further includes a cannula disposed within the cavity and configured to pierce the septum of the syringe or blood collection tube in response to the syringe or blood collection tube being advanced into the cavity of the adapter, and wherein the extension tube extends through the proximal end of the housing.

18. A vascular access device comprising: A housing including a proximal end and a distal end; A sleeve including a proximal end and a distal end, the proximal end of the sleeve being coupled to the distal end of the housing, wherein the distal end of the sleeve is configured to be coupled to a catheter assembly, and wherein the sleeve is collapsible in a distal direction; and An instrument disposed within the sleeve, wherein the instrument includes a proximal end and a blunt distal tip, and wherein the instrument includes a catheter or a probe, and wherein the instrument is configured to be movable relative to the housing from a proximal position to a distal position, and wherein when the instrument is disposed in the distal position, the instrument is advanced beyond the distal end of the sleeve, and wherein when the sleeve collapses in the distal direction, the instrument is advanced to a position beyond the distal end of the housing.

19. The vascular access device according to claim 18, wherein, The device includes a catheter and further includes an adapter coupled to the proximal end of the device, wherein the adapter includes a cavity configured to receive a syringe or a blood collection tube, and wherein the adapter further includes a cannula disposed within the cavity and configured to pierce a septum of the syringe or the blood collection tube in response to the syringe or the blood collection tube being advanced into the cavity of the adapter.

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