catheter assembly

Abstract

This application relates to catheter assemblies. The catheter assembly includes: a catheter adapter including a distal end, a proximal end, and a lumen extending between the distal end and the proximal end; and a septum disposed within the lumen, wherein the septum includes a proximal surface that tapers inwardly in a distal direction, such that the proximal surface is configured to guide a probe or catheter distally through the septum. This application also relates to a system for facilitating device delivery via peripheral intravenous catheters.

Description

[0001] This application is a divisional application of the invention patent application entitled "System and method for improving device guidance within an intravenous catheter assembly", with an international application date of July 18, 2018, international application number PCT / US2018 / 042614, and national application number 201880055660.6. Technical Field

[0002] This application relates to catheter assemblies. Background Technology

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

[0004] The most common type of catheter is the needle-type peripheral intravenous (“IV”) catheter. As the name suggests, a needle-type catheter is mounted on a guide needle with a sharp distal end. The catheter and guide needle can be assembled such that the distal end of the guide needle extends beyond the distal end of the catheter, with the bevel of the needle facing upwards away from the patient's skin. The catheter and guide needle are typically inserted into the patient's vascular system through the skin at a shallow angle.

[0005] To verify proper placement of the guide needle and / or catheter in a blood vessel, clinicians typically confirm the presence of blood "flashback" in the flashback chamber of the catheter assembly. Once needle placement is confirmed, the clinician can temporarily block blood flow in the vascular system and remove the needle, leaving the catheter in place for future blood draws or infusions.

[0006] For a variety of reasons, drawing blood using peripheral IV catheters can be difficult, especially when the catheter is in place for more than a day. For example, when a catheter is inserted into a patient for an extended period, it is more likely to narrow, collapse, become kinked, become blocked by debris (such as fibrin or platelet clots), and the catheter tip may adhere to the vascular system. Therefore, while catheters are typically used for blood sampling during placement, they are rarely used for blood sampling during catheter indwelling. Consequently, when blood sampling is needed, additional needle puncture may be required to provide intravenous access for blood collection, which can be painful for the patient and result in higher material costs. Therefore, there is a need for catheter systems and methods that facilitate the placement of blood sampling instruments (such as catheters) and probe instruments into a patient's vascular system without the need for additional needle puncture. Summary of the Invention

[0007] This application generally relates to device 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 diaphragm housing, and a diaphragm.

[0008] In some embodiments, the catheter adapter may include a distal end, a proximal end, and an inner cavity extending between the distal end and the proximal end. In some embodiments, a diaphragm may be disposed within the inner cavity of the catheter adapter. In some embodiments, the diaphragm may be at least partially disposed within a diaphragm housing and configured to at least substantially seal the inner cavity of the catheter adapter. In some embodiments, the diaphragm housing may prevent diaphragm displacement or instability, thereby preventing fluid leakage from the inner cavity of the catheter adapter.

[0009] 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 the Becton Dickinson NEXIVA. TM Closed IV catheter system, Becton Dickinson NEXIVA TM DIFFUSICS TM Closed IV catheter system or Becton Dickinson PEGASUS TM A safe, closed IV 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 engage at a common lumen. In some embodiments, the first lumen may be substantially aligned with the common lumen and / or the second port may include a side port. In some embodiments, a diaphragm and / or a diaphragm housing may be disposed within the first lumen.

[0010] In a closed IV catheter system, the guide needle can be withdrawn via the catheter adapter after the catheter has been inserted into the patient's vascular system. In a closed IV catheter system, when the guide needle is withdrawn via the catheter adapter, a diaphragm can isolate a first lumen from the external environment surrounding the catheter adapter; this first lumen may correspond to a "needle channel." Therefore, the diaphragm can 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 aspiration, the fluid path of the catheter assembly may extend through a second port instead of the first port.

[0011] In some embodiments, the second lumen of the catheter adapter may be connected to a blood aspiration or infusion device via an extension tube that extends from the second port of the catheter adapter. In some embodiments, a diaphragm and / or a diaphragm 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 a non-integrated catheter system or a catheter system without an integrated extension tube.

[0012] In some embodiments, the device may include another catheter or probe. In some embodiments, the device may include a variable diameter along its length. In some embodiments, the device may be guided by one or more features of the catheter system (e.g., one or more tapered surfaces) to allow the device to access the fluid pathway of the catheter assembly and / or the patient's vascular system. In some embodiments, one or more features of the catheter system may guide the device through a septum to access the fluid pathway. In some embodiments, accessing the fluid pathway and / or vascular system through a septum avoids the need for insertion of the device via a long and tortuous path with an integrated extension kit.

[0013] In some embodiments, the diaphragm may include a proximal surface that tapers inward in a distal direction, such that the proximal surface is configured to guide a device distally through the diaphragm. In some embodiments, the diaphragm may include a cavity. In some embodiments, the distal end of the cavity may include an annular protrusion that may form the proximal surface of the diaphragm. In some embodiments, the diaphragm may include a slit disposed at or near the center of the annular protrusion or within the annular protrusion. In some embodiments, the proximal surface of the diaphragm may include an inner surface of the diaphragm or a surface of the diaphragm disposed toward the slit of the diaphragm.

[0014] In some embodiments, the diaphragm housing may include a proximal surface that tapers inward in a distal direction, such that the proximal surface of the diaphragm housing is configured to guide a device distally through the diaphragm. In some embodiments, the diaphragm housing may include a distal end and a proximal end. In some embodiments, the diaphragm may be at least partially disposed within the distal end of the diaphragm housing. In some embodiments, the proximal end of the diaphragm housing may include a proximal surface of the diaphragm housing. In some embodiments, the diaphragm housing may include a canister.

[0015] In some embodiments, the catheter system may include an extension or guide that may be configured to introduce an instrument into the catheter assembly. In some embodiments, the guide may include a guide element that may be coupled to a proximal end of the catheter adapter. In some embodiments, the proximal end of the guide element may include an opening formed at least partially by a proximal surface and / or an inner surface. In some embodiments, the inner surface may taper inward in a distal direction such that the inner surface is configured to guide an instrument distally through the guide element and into the proximal end of the catheter adapter.

[0016] In some embodiments, the proximal end of the guide element may include a coupling mechanism. In some embodiments, the distal end of the guide element may include a tube or tubular element. In some embodiments, in response to the guide being coupled to the catheter adapter via the coupling mechanism, the tube may penetrate the septum and / or extend near the proximal side of the septum, which can aid in guiding the instrument within the catheter assembly. In some embodiments, the distal end of the tube may be blunt, which can prevent damage to the septum.

[0017] In some embodiments, the guide may include a cover disposed above or at least partially covering the tube. In some embodiments, the cover may contact a proximal side of the diaphragm. In some embodiments, the cover may be elastomeric. In some embodiments, the cover may include a slit that may assist instrument penetration through the cover. In some embodiments, the slit of the cover may be aligned with a slit in the diaphragm. In some embodiments, the cover may include one or more antimicrobial agents. In some embodiments, the cover may be configured to seal the guide when the diaphragm is closed to prevent any fluid leakage through the diaphragm.

[0018] In some embodiments, the guide may include a sheath or cannula that may be coupled to a guide element. In some embodiments, the cannula may surround the instrument, which may protect the instrument from the external environment surrounding the guide. In some embodiments, the instrument may be at least partially disposed within the cannula. In some embodiments, the instrument may advance to a position beyond the distal end of the cannula when the cannula is compressed or collapsed in a distal direction. In some embodiments, the guide may include a grip that may be coupled to the proximal end of the cannula. In some embodiments, a clinician may move the grip distally to compress or collapse the cannula in a distal direction and advance the instrument to a position beyond the distal end of the cannula. In some embodiments, a coupling mechanism may be coupled to a specific port of a catheter adapter. In some embodiments, a diaphragm may prevent fluid from leaving the catheter adapter via the specific port. In some embodiments, the cannula may be at least partially disposed within a housing, as will be described in further detail. Attached Figure Description

[0019] To facilitate understanding of the manner in which the above and other features and advantages of the present invention are obtained, the invention, which has been briefly described above, will be described in more detail with reference to specific embodiments of the invention shown in the accompanying drawings. These drawings depict only exemplary embodiments of the invention and should not be construed as limiting the scope of the invention.

[0020] Figure 1A This is a cross-sectional top view of an exemplary catheter assembly according to some embodiments;

[0021] Figure 1B According to some embodiments Figure 1A A partial exploded view of the catheter assembly;

[0022] Figure 1C It is constructed according to some embodiments to be similar to Figure 1A A top perspective view of an exemplary needle hub connected to a catheter assembly;

[0023] Figure 2A This is a cross-sectional view of an exemplary diaphragm including guiding features according to some embodiments;

[0024] Figure 2B According to some embodiments, including Figure 2A A cross-sectional view of another exemplary diaphragm with one guiding feature and another guiding feature;

[0025] Figure 2C This is a cross-sectional view of a diaphragm housing having another exemplary guiding feature according to some embodiments;

[0026] Figure 2D According to some embodiments Figure 2C A perspective view of the upper part of the diaphragm housing;

[0027] Figure 3A This is a cross-sectional view of an exemplary guide coupled to another example catheter assembly according to some embodiments, showing the guide in a first position;

[0028] Figure 3B According to some embodiments Figure 3A A cross-sectional view of the guide, showing the guide in the second position;

[0029] Figure 3C This is a cross-sectional view of another exemplary guide according to some embodiments, showing the guide in a second position;

[0030] Figure 3D This is a cross-sectional view of an exemplary cover disposed on an exemplary guide element according to some embodiments;

[0031] Figure 4AThis is a cross-sectional view of another exemplary guide according to some embodiments;

[0032] Figure 4B According to some embodiments Figure 4A A cross-sectional view of the guide; and

[0033] Figure 5 According to some embodiments Figure 4A A cross-sectional view of the guide. Detailed Implementation

[0034] The presently preferred embodiments of the invention can be understood by referring to the accompanying drawings, wherein similar reference numerals denote the same or functionally similar elements. It will be readily understood that, as generally described and illustrated in the accompanying drawings, the components of the invention can be arranged and designed in a variety of different configurations. Therefore, as shown in the drawings, the following more detailed description is not intended to limit the scope of the claimed invention, but merely represents the presently preferred embodiments of the invention. Furthermore, the drawings may show simplified or partial views, and for clarity, the dimensions of elements in the drawings may be enlarged or not to scale.

[0035] As used in this disclosure, the terms “proximal” and “distal” can refer, respectively, to directions closer to and further away from the clinician who positions the catheter system to contact the 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 manipulated by the clinician) will be the proximal end of the catheter system.

[0036] This application generally relates to device guidance within a catheter system, which may include a peripheral IV catheter system. Reference is now made to... Figure 1A -1C, In some embodiments, the catheter system may include a catheter assembly 10. In some embodiments, the catheter assembly may include one or more of the following: a catheter 12, a catheter adapter 14, a diaphragm housing 16, and a diaphragm 18.

[0037] In some embodiments, the catheter adapter 14 may include a distal end, a proximal end, and an inner cavity 20 extending between the distal end and the proximal end. In some embodiments, a diaphragm 18 may be disposed within the inner cavity 20 of the catheter adapter 14. In some embodiments, the diaphragm 18 may be at least partially disposed within a diaphragm housing 16. In some embodiments, the diaphragm housing 16 may prevent displacement or instability of the diaphragm 18, thereby preventing fluid leakage from the catheter adapter 14. In some embodiments, the diaphragm 18 and the diaphragm housing 16 may each include or correspond to either the diaphragm 18 or the diaphragm housing 16, as shown in any of the other figures.

[0038] In some embodiments, the catheter assembly 10 may be part of a closed IV catheter system or a catheter system with an integrated extension tube, for example, Closed IV catheter system Closed IV catheter system or A secure closed IV catheter system. In these and other embodiments, the proximal end of the catheter adapter 14 may include a first port 22 and a second port 24. In these and other embodiments, the lumen 20 of the catheter adapter 14 may include a first lumen 20a and / or a second lumen 20b. In some embodiments, the first port 22 may form the first lumen 20a and / or the second port 24 may form the second lumen 20b. In some embodiments, the first and second lumens 20a, 20b may engage at a common lumen 20c. In some embodiments, the first lumen 20a may be substantially aligned with the common lumen 20c and / or the second port 24 may include a side port. In some embodiments, a diaphragm 18 and / or a diaphragm housing 16 may be disposed in the first lumen 20a. In some embodiments, the diaphragm 18 may be configured to at least substantially seal the first lumen 20a of the catheter adapter 14.

[0039] In integrated or closed IV catheter systems, after catheter 12 is inserted into the patient's vascular system, the guide needle 26 can be withdrawn via catheter adapter 14. In integrated or closed IV catheter systems, when the guide needle 26 is withdrawn via catheter adapter 14, the first lumen 20a corresponding to the "needle channel" can be closed by diaphragm 18 to isolate it from the external environment surrounding catheter adapter 14. Therefore, diaphragm 18 prevents fluid from leaving catheter adapter 14 through first port 22. In some embodiments, during fluid infusion and / or blood aspiration, the fluid path of catheter assembly 10 may extend through second port 24 and may not extend through first port 22 and diaphragm 18.

[0040] In some embodiments, the second inner cavity 20b of the catheter adapter 14 may be connected to a blood extraction or infusion device via an extension tube 28 that extends from the second port 24 of the catheter adapter 14. In some embodiments, a diaphragm 18 and / or a diaphragm housing 16 may be disposed proximal to the second port 24 of the catheter adapter 14.

[0041] It should be understood that the catheter assembly 10 may include any number of ports. For example, the catheter assembly 10 may include a single port in which a diaphragm 18 and / or a diaphragm housing 16 may be disposed. In some embodiments, the catheter assembly 10 may include a first port 22, a second port 24, and one or more additional ports. In some embodiments, the diaphragm 18 may prevent fluid from leaving the catheter adapter 14 via a specific port in which the diaphragm 18 is disposed. In some embodiments, the catheter assembly 10 may be part of another type of catheter system, such as a non-integrated catheter system. In some embodiments, the extension tube 28 and / or the second port 24 may be absent. In these and other embodiments, the fluid path of the catheter adapter 14 may extend through the diaphragm 18.

[0042] In some embodiments, the diaphragm 18 may include a slit 40. More specifically, in some embodiments, the slit 40 may be pre-formed in the diaphragm 18 before the guide needle 26 is inserted through it, or the slit 40 may be formed as the guide needle 26 is inserted through the diaphragm 18. In some embodiments, the guide needle 26 may be coupled to a needle holder 27, which may include a needle safety mechanism.

[0043] Now for reference Figure 2A -2C, In some embodiments, the device may include another catheter and / or probe 30. Figure 2A An example of probe 30 is shown in -2C. However, probe 30 can be replaced by another catheter, in Figure 3A An example of this catheter is shown in -3B. In some embodiments, the device can simultaneously function as probe 30 and another catheter. In some embodiments, the device can be used to perform one or more of the following: diagnosis, blood sampling, monitoring, and one or more other purposes.

[0044] In some embodiments, the device may be guided by one or more features of the catheter system (e.g., one or more tapered surfaces) to allow access to the fluid pathway of the catheter assembly 10 and / or the patient's vascular system. In some embodiments, one or more features of the catheter system may include an introduction feature and / or a device-guided feature through the diaphragm 18 to access the fluid pathway of the catheter assembly 10. In some embodiments, access to the fluid pathway and / or vascular system via the diaphragm 18 avoids the need for long and tortuous insertion of the device through an integrated extension kit.

[0045] In some embodiments, another catheter may include a replacement catheter, which may be needle-free. In some embodiments, probe 30 may include one or more openings 31 and / or one or more sensors 32. In some embodiments, openings 31 and / or sensors 32 may be positioned toward the distal end of probe 30. In some embodiments, opening 31 may serve as a fluid inlet and / or outlet. In some embodiments, sensor 32 may measure one or more parameters and / or detect one or more elements related to, for example, diagnostic information, blood biochemistry, pressure, flow rate, drug recognition, microbiology, placement of implantable stents, intravenous catheter tip stability features, or other devices. In some embodiments, one or more features may facilitate placement of a portion of probe 30, including sensor 32, within the fluid path of catheter assembly 10 and / or within the patient's vascular system.

[0046] In some embodiments, the diaphragm 18 may be a low-resistance diaphragm designed to reduce friction on instruments passing through the diaphragm 18, which can facilitate instrument passage. In some embodiments, the diaphragm 18 may be configured to withstand high pressure within the catheter assembly 10. In some embodiments, the diaphragm housing 16 and / or the diaphragm 18 may be secured within the catheter adapter 14 in any manner. In some embodiments, the diaphragm housing 16 may include one or more protrusions 34. In some embodiments, the one or more protrusions 34 may include a lip. In some embodiments, the diaphragm housing 16 may be secured to the inner wall of the catheter adapter 14 by one or more of the following methods: an interference fit between the one or more protrusions 34 and the inner wall, a snap-fit ​​fit between the one or more protrusions 34 and the inner wall, an engagement between the one or more protrusions 34 and the inner wall, and threading the one or more protrusions 34 to the inner wall. In some embodiments, the inner wall may include a groove or an opening.

[0047] In some embodiments, the diaphragm housing 16 may be resilient and, in response to alignment of one or more protrusions 34 with a recess or opening, the diaphragm housing 16 may resiliently move outward to retain one or more protrusions 34 within the recess or opening in a snap-fit ​​engagement. More specifically, in some embodiments, in response to insertion of the diaphragm housing 16 into the proximal end of the catheter adapter 14, one or more protrusions 34 may be biased inward, and / or in response to further insertion of one or more protrusions into the proximal end and alignment with a recess or opening, one or more protrusions 34 may resiliently move outward such that one or more protrusions 34 are retained within the recess or opening.

[0048] In some embodiments, the bonding between the diaphragm housing 16 and the inner wall and / or between the diaphragm 18 and the inner wall can be provided at various locations on the inner wall. In some embodiments, one or more of the following can be provided on all or some of the contact surfaces of the inner wall and / or the diaphragm 18: adhesive bonding, chemical bonding, ultrasonic welding, and laser welding. Additionally or alternatively, one or more of the following can be provided on all or some of the contact surfaces of the inner wall and / or the diaphragm housing 16: adhesive bonding, chemical bonding, ultrasonic welding, and laser welding.

[0049] In some embodiments, the diaphragm 18 and / or the diaphragm housing 16 may be retained within the catheter adapter 14 without mechanical or interference engagement with the diaphragm housing 16. For example, the proximal end of the catheter adapter 14 may abut against and extend over a portion of the surface region of the proximal side of the diaphragm 18 and / or the diaphragm housing 16, thereby retaining the diaphragm 18 and / or the diaphragm housing 16 within the catheter adapter 14. Thus, due to the abutment at the proximal end of the catheter adapter 14, and therefore partially blocking the wall of the proximal end of the catheter adapter 14, the catheter adapter 14 can prevent proximal movement of the diaphragm 18 and / or the diaphragm housing 16 within the catheter adapter 14.

[0050] Now for reference Figure 2A -2B, In some embodiments, the diaphragm 18 may include one or more guiding features that facilitate distal guidance of a device through the diaphragm 18. For example, in some embodiments, the diaphragm 18 may include a proximal surface that tapers inward in a distal direction, such that the proximal surface of the diaphragm 18 is configured to guide a device distally through the diaphragm 18. In some embodiments, the proximal surface of the diaphragm 18 may be funnel-shaped or conical. In some embodiments, the diaphragm 18 may include a cavity 36. In some embodiments, the distal end of the cavity 36 may include the proximal surface of the diaphragm 18. In some embodiments, a slit 40 of the diaphragm 18 may be located at or near the center of the proximal surface. In some embodiments, the distal end of the cavity 36 may include an annular protrusion 38 that may form the proximal surface of the diaphragm 18. In some embodiments, the slit 40 may be located at or near the center of the annular protrusion 38. In some embodiments, one or more guiding features of the diaphragm 18 may include ribs, protrusions, grooves, or other guiding features that may aid in the orientation of the device. In some embodiments, the proximal surface of the diaphragm 18 may include one or more guiding features. In some embodiments, the guiding device may include contact with one or more guiding features.

[0051] In some embodiments, one or more guiding features of the diaphragm 18 may be provided at the proximal end of the diaphragm 18. For example, the proximal surface of the diaphragm 18 may be provided at the proximal end of the diaphragm 18. Figure 2BThe proximal surface disposed at the proximal end of the diaphragm and, for example, the proximal surface of the funnel-shaped 41 are shown.

[0052] Now for reference Figure 2C -2D, In some embodiments, the diaphragm housing 16 may include one or more guiding features that facilitate distal guidance of the device through the diaphragm 18 and / or the diaphragm housing 16. For example, in some embodiments, the diaphragm housing 16 may include a proximal surface 39 that tapers inward in a distal direction, such that the proximal surface 39 is configured to guide the device distally through the diaphragm 18. In some embodiments, the proximal surface 39 may be funnel-shaped or conical. In some embodiments, the diaphragm housing 16 may include a distal end and a proximal end. In some embodiments, the diaphragm 18 may be at least partially disposed within the distal end of the diaphragm housing 16. In some embodiments, the proximal end of the diaphragm housing 16 may include the proximal surface 39. In some embodiments, the diaphragm housing 16 may include a canister, such as... Figure 2D As shown.

[0053] In some embodiments, one or more guiding features of the diaphragm housing 16 may include ribs, protrusions, grooves, or other guiding features that may aid in the orientation of the device. In some embodiments, the proximal surface of the diaphragm housing 16 may include guiding features. Figure 2C The proximal surface of the diaphragm 18 shown is illustrated as a funnel shape 41, which serves as an exemplary proximal surface. In some embodiments, a particular port of the catheter adapter 14 may include one or more guiding features of the diaphragm housing 16 and / or the diaphragm housing 16 may be integrally formed with the particular port of the catheter adapter 14.

[0054] Now for reference Figure 3A -3B, In some embodiments, the catheter system may include a guide 42, which may be configured to introduce an instrument into the catheter assembly 10. In some embodiments, the instrument may include another catheter 46, such as... Figure 3A As shown in -3B. However, catheter 46 can be replaced by probe 30, in Figure 2A An example of the probe is shown in -2C. In some embodiments, the instrument may simultaneously function as both probe 30 and another catheter 46, comprising elements of both probe 30 and another catheter 46.

[0055] In some embodiments, the guide 42 may include a guide element 44 that may be coupled to the proximal end of the catheter adapter 14. In some embodiments, the guide element 44 may include one or more guiding features that may facilitate distal guidance of the device through the diaphragm. As an example, in some embodiments, the proximal end of the guide element 44 may include an opening 48 formed at least partially by a proximal surface / or an inner surface 57, the opening being distally tapering inward such that the inner surface 57 is configured to guide the device distally through the guide element 44 and through a slit 40 of the diaphragm 18. In some embodiments, the inner surface 57 may be conical or funnel-shaped, for example as... Figure 3A As shown. In some embodiments, the inner surface 57 may include one or more ribs, protrusions, grooves, or other guiding features that may aid in the orientation of the instrument.

[0056] In some embodiments, the guide element 44 may include one or more coupling mechanisms that facilitate connection between the proximal end of the catheter adapter 14 and the guide element 44, preventing fluid leakage and / or contamination of the fluid path when the instrument is inserted into the catheter assembly 10. More specifically, in some embodiments, the guide element 44 may be coupled to the proximal end of the catheter adapter 14 in any manner (e.g., snap-fit, threaded, press-fit, interference fit, or other suitable manner). In some embodiments, a specific coupling mechanism of the guide element 44 may be coupled to a specific port of the catheter adapter. Figure 3A As shown in -3B, in some embodiments, one or more protrusions may engage with one or more recesses of the catheter adapter 14.

[0057] In some embodiments, the catheter adapter 14 and / or guide element 44 may be integrally formed as a single piece. In some embodiments, the device may be coupled to the guide element 44. In other embodiments, the device may not be coupled to the guide element 44.

[0058] In some embodiments, the guide 42 may include a sheath or cannula 50 that can be coupled to the guide element 44. In some embodiments, the cannula 50 may surround the device. In these and other embodiments, the cannula 50 may protect the device from contaminants and / or isolate any blood or other fluid that may remain on the device after the fluid path of the access catheter assembly 10. In these and other embodiments, the cannula 50 may protect the device from the external environment surrounding the guide 42.

[0059] In some embodiments, the instrument may be at least partially disposed within the cannula 50. In some embodiments, the cannula 50 may be constructed of a flexible and / or compliant material. In some embodiments, the cannula 50 may collapse or compress axially. More specifically, in some embodiments, when the cannula collapses or compresses in a distal direction, the instrument may advance to a position beyond the distal end of the cannula 50. In some embodiments, the guide 42 may include a handle or grip 52 that may be coupled to the proximal end of the cannula 50. In some embodiments, a clinician may move the grip 52 distally to cause the cannula 50 to collapse or compress in a distal direction and advance the instrument to a position beyond the distal end of the cannula 50.

[0060] In some embodiments, various types of sleeves 50 may be used. In some embodiments, the guide 42 may include a housing (not shown) that may be coupled to the guide element 44. In some embodiments, the housing may include one or more components, such as concentric cylinders. In some embodiments, at least a portion of the housing may be axially collapsed or axially compressed. For example, a first concentric cylinder may advance into a second concentric cylinder.

[0061] In some embodiments, the cannula 50 may be at least partially disposed within a housing, which may be rigid or semi-rigid. An exemplary housing is described in U.S. Provisional Patent Application No. 62 / 534,552, filed July 19, 2017, entitled “Extension for Receiving a Probe or Intravenous Catheter,” the entire contents of which are incorporated herein by reference. In some embodiments, the housing may include a groove. In some embodiments, a tab or adapter may be associated with or near the proximal end of the instrument. In some embodiments, the tab or adapter may be configured to move along the groove from a proximal position to a distal position. In some embodiments, in response to the adapter moving from the proximal position to the distal position, the instrument may advance beyond the distal end of the cannula 50 and / or the housing. In some embodiments, the adapter may include a lumen configured to receive a syringe or blood collection tube and / or a cannula configured to puncture a septum of the syringe and / or blood collection tube. Exemplary slots and example adapters are described in U.S. Provisional Patent Application No. 62 / 534,552, filed July 19, 2017, entitled “Extension for Receiving Probes or Intravenous Catheters.”

[0062] As mentioned, in some embodiments, at least a portion of the housing may be axially collapsed or axially compressed. For example, the housing may include one or more collapsible and / or telescopic cylinders. Additionally or alternatively, the housing may include a groove. In some embodiments, a first concentric cylinder may advance into a second concentric cylinder. In some embodiments, at least a portion of the first and / or second concentric cylinders may be collapsed.

[0063] In some embodiments, the guide 42 may not include the cannula 50 and / or the gripping portion 52. In these and other embodiments, the guide element 44 may have an extended length such that a portion of the guide element 44 protrudes from beneath the dressing used to cover the insertion site of the catheter 12, thereby facilitating access to the diaphragm 18 and / or support device.

[0064] In some embodiments, the guide element 44, the grip 52, or another portion of the guide 42 may be connected to a Luer connector, Becton Dickinson LUER-LOK. TM Access device or another device for blood collection and / or monitoring. In some embodiments, the fluid path of the guide 42 may extend through the grip 52. In some embodiments, the guide element 44, the grip 52, or another portion of the guide 42 may be connected to a monitoring interface and / or a monitoring device.

[0065] Now for reference Figure 3C In some embodiments, guide element 44 may include a coupling mechanism. In some embodiments, the proximal end of guide element 44 may include the coupling mechanism. In some embodiments, the distal end of guide element 44 may include a tube 54. In some embodiments, the coupling mechanism may be located proximal to the tube 54. In some embodiments, in response to guide 42 being coupled to catheter adapter 14 via the coupling mechanism of guide element 44, tube 54 may be located within lumen 36 and / or proximal to diaphragm 18. In these and other embodiments, tube 54 may not penetrate diaphragm 18. In these and other embodiments, tube 54 may contact proximal to diaphragm 18 near slit 40. In some embodiments, proximal to diaphragm 18 may be located within lumen 36, although in some embodiments, diaphragm 18 may not include lumen 36 and / or first and second proximally extending arms forming lumen 36. In some embodiments, the width of tube 54 may be approximately equal to the width of lumen 36. In some embodiments, the distal end of tube 54 may be blunt, which may prevent damage to diaphragm 18. In some embodiments, tube 54 may extend from the bottom 56 portion of guide element 44. Figure 3C Probe 30 is shown, and as previously described, the probe can be replaced by another conduit 46.

[0066] Now for reference Figure 3DIn some embodiments, guide element 44 may include a fluid seal that prevents fluid from entering the distal opening of tube 54. For example, guide element 44 may include a cover 58 configured to be permeable by a device and provide a seal between diaphragm 18 and guide element 44. In some embodiments, cover 58 is disposed on top of or at least partially covers tube 54. In some embodiments, cover 58 may cover the distal opening of tube 54. In some embodiments, cover 58 may be elastomeric and compliant. In some embodiments, cover 58 may include a slit 60 that facilitates device penetration of cover 58. In some embodiments, cover 58 may include one or more antimicrobial agents. In some embodiments, cover 58 may contribute to a fluid seal on the proximal side of diaphragm 18.

[0067] In some embodiments, the guide 42 may include at least one valve 59, which can provide a seal against instrument penetration. In some embodiments, the valve 59 may include a slit. The valve 59 of the guide 42 may be located in any number of positions to prevent fluid from the catheter assembly 10 from entering all or part of the guide 42 and / or exiting the proximal end of the guide. Figure 3D An exemplary valve 59 is shown. In some embodiments, the guide 42 may include the valve 59 and / or the cover 58. In some embodiments, when the guide 42 does not penetrate the diaphragm 18, for example in Figure 3C In this configuration, the guide 42 may not include the valve 59 and / or the cover 58.

[0068] In some embodiments, for example, any component of the catheter system (including any component of guide 42 and / or any component of catheter assembly 10) may include one or more antimicrobial agents, such as antimicrobial coatings, antimicrobial lubricants, etc. In some embodiments, antimicrobial agents may reduce the risk of contaminating the fluid path of the catheter system.

[0069] Now for reference Figure 4A -4B, In some embodiments, in response to the guide 42 being coupled to the catheter adapter 14 via the coupling mechanism of the guide element 44, the tube 54 may penetrate the diaphragm 18. In these and other embodiments, fluid flow within the lumen 36 of the diaphragm 18 may be reduced and / or compressive axial load on the device may be reduced compared to when the device itself opens the diaphragm 18. In some embodiments, the distal end of the tube 54 may be blunt, which may prevent damage to the diaphragm 18. In some embodiments, Figure 4A The guide 42 of -4B may include a sleeve 50, a gripping portion 52, and one or more of one or more other components discussed with respect to Figures 1 through 3. Figure 4 shows a conduit 46 prior to insertion into the guide element 44 according to some embodiments.

[0070] exist Figure 4B Another exemplary valve 59 is shown. In some embodiments, valve 59 may be disposed within a needleless connector. In some embodiments, the needleless connector may form the proximal end of guide element 44. In some embodiments, valve 59 may be disposed distal to diaphragm 18 within catheter adapter 14. In these embodiments, tube 54 may penetrate diaphragm but not valve 59, and instrument may penetrate valve 59. In some embodiments, valve 59 may provide less resistance to instrument compared to diaphragm 18.

[0071] Now for reference Figure 5 As previously explained, in some embodiments, the guide element 44 can be coupled to the proximal end of the catheter adapter 14 via any number of coupling mechanisms. For example, the guide element 44 can be coupled to the proximal end of the catheter adapter via snap-fit, thread, press-fit, interference fit, etc. In some embodiments, the guide element 44 may include a connector 62, which may include one or more coupling mechanisms, such as threads, etc. Figure 5 As shown. In some embodiments, connector 62 may be coupled to the proximal end of catheter adapter 14 via one or more coupling mechanisms. In some embodiments, connector 62 may be removed from guide element 44 and / or catheter adapter 14. In other embodiments, connector 62 may not be removed from guide element 44 and / or catheter adapter 14 or may be permanently coupled to said guide element and / or catheter adapter. Figure 5 A guide element 44 coupled to sleeve 50 is shown according to some embodiments.

[0072] The invention may be practiced in other specific forms without departing from the structure, method, or other essential features of the invention as broadly described herein and claimed hereinafter. The described embodiments should be considered illustrative in all respects only, and not restrictive. Therefore, the scope of the invention is indicated by the appended claims rather than the foregoing description. All modifications falling within the equivalent meaning and scope of the claims should be included within their scope.

Claims

1. A catheter assembly, the catheter assembly comprising: A catheter adapter, the catheter adapter including a distal end, a proximal end, and an inner lumen extending between the distal end and the proximal end; and A diaphragm disposed within the inner cavity, wherein the diaphragm includes a slit, an annular protrusion, and an annular wall, wherein the annular protrusion and the annular wall define a cavity within the diaphragm, and wherein: The annular protrusion extends from the distal portion of the diaphragm in a proximal direction relative to the slit and within the annular wall, and includes a curved proximal surface configured to receive and guide a probe or catheter toward the slit, the curved proximal surface defining the distal end of the lumen.

2. The catheter assembly according to claim 1, wherein, The slit is located at the center of the annular protrusion.

3. The catheter assembly according to claim 1, wherein the catheter assembly further comprises an extension tube, wherein, The proximal end of the catheter adapter includes a first port and a second port, wherein the lumen includes a first inner lumen, a second inner lumen, and a common inner lumen, wherein the first port forms the first inner lumen, the second port forms the second inner lumen, wherein the first inner lumen and the second inner lumen are joined at the common inner lumen, wherein the first inner lumen is aligned with the common inner lumen, wherein a diaphragm is disposed in the first inner lumen to prevent fluid from leaving the catheter adapter through the first port, and wherein the second port is connected to an extension tube.

4. The catheter assembly according to claim 1, wherein the catheter assembly further comprises a diaphragm housing, wherein, The diaphragm is at least partially disposed within the diaphragm housing, wherein the diaphragm housing includes a proximal inner surface that tapers inward in a distal direction, such that the proximal inner surface of the diaphragm housing is configured to guide the probe or the conduit distally through the diaphragm.

5. The catheter assembly according to claim 4, wherein, The diaphragm housing includes a distal end and a proximal end, wherein the diaphragm is at least partially disposed within the distal end of the diaphragm housing, and wherein the proximal end of the diaphragm housing includes the proximal inner surface of the diaphragm housing.

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