Catheter systems and related devices for instrument delivery

Abstract

An instrument delivery device for insertion of an instrument (44) through a catheter assembly (48) may include a housing, a connector (42) coupled to the housing, a slider configured to move along a slot of the housing, and an instrument (44) disposed within the housing and coupled to the slider. The instrument may be configured to advance beyond the connector in response to movement of the slider along the slot from a proximal position to a distal position. The connector may include a curved portion 66 configured to change the direction of the instrument when the instrument is advanced through the connector.

Description

BACKGROUND

[0001] Catheters are commonly used to infuse fluids into a patient's vasculature. For example, catheters can be used to infuse solutions of physiological saline, various medicaments, or total parenteral nutrition. Catheters can also be used to withdraw blood from a patient.

[0002] Catheters can include an over-the-needle intravenous ("IV") catheter. In this case, the catheter can be mounted on an introducer needle having a sharp distal tip. The catheter and introducer needle can be assembled so that the distal tip of the introducer needle extends beyond the distal tip of the catheter with the bevel of the needle facing upward away from the patient's skin. The catheter and introducer needle are typically inserted through the skin at a shallow angle into the patient's vasculature.

[0003] To verify proper placement of the introducer needle and / or catheter in the blood vessel, the clinician will typically confirm the presence of "flashback" of blood in the flashback chamber of the catheter assembly, including the catheter. Once placement of the needle is confirmed, the clinician can temporarily occlude flow in the vasculature and remove the needle, leaving the catheter in place for future blood withdrawal or fluid infusion.

[0004] Blood withdrawal using a catheter can be difficult for several reasons, particularly when the catheter has been left in place for more than a day. For example, the catheter or vein can be more susceptible to narrowing, collapsing, kinking, occlusion by debris (e.g., fibrin or platelet clots), and positioning of the catheter tip into the vasculature as the catheter is left in place in the patient for an extended period of time. Thus, catheters can be frequently used to collect blood samples at the time of catheter placement, but are used much less frequently to collect blood samples during the catheter dwell period. Therefore, when a blood sample is needed, an additional needle stick is required to provide venous access for blood collection, which can be painful for the patient and results in higher material costs. Thus, there is a need for catheter systems, devices, and methods that facilitate placement of an instrument (e.g., a flexible flow conduit or probe for blood collection) in a patient's vasculature without an additional needle stick.

[0005] The subject matter claimed herein is not limited to implementations that solve any disadvantages or that operate only in environments such as those described above. Rather, this background is included as merely representative of one example technology area where some implementations disclosed herein can be practiced. SUMMARY

[0006] In some embodiments, the present disclosure is generally directed to an instrument delivery device and / or catheter system for facilitating delivery of an instrument into a patient's vasculature. In some embodiments, the present disclosure is generally directed to a connector for facilitating delivery of an instrument into a patient's vasculature. In some embodiments, the present disclosure is generally directed to a method for facilitating delivery of an instrument into a patient's vasculature.

[0007] In some embodiments, an instrument delivery device for inserting an instrument through a catheter assembly can include a housing. In some embodiments, the housing can include a proximal end, a distal end, and a slot disposed between the proximal end of the housing and the distal end of the housing. In some embodiments, the instrument delivery device can include a connector coupled to the distal end of the housing. In some embodiments, the instrument delivery device can include a slider configured to move along the slot. In some embodiments, the instrument delivery device can include an instrument disposed within the housing and coupled to the slider.

[0008] In some embodiments, the instrument can be configured to advance beyond the connector in response to movement of the slider along the slot from a proximal position to a distal position. In some embodiments, the connector can include a curved portion configured to change a direction of the instrument as the instrument advances through the connector. In some embodiments, the instrument can include a flexible flow tube configured to extend through an indwelling catheter for blood collection. In some embodiments, the curved portion can be configured to change the direction of the instrument by 90° as the instrument advances through the connector. In some embodiments, the curved portion can include a channel. In some embodiments, the curved portion can include an enclosed passageway.

[0009] In some embodiments, the enclosed passageway can be disposed within a straight end of the connector. In some embodiments, the connector can include a male luer that is configured to form a seal within the catheter assembly, and the straight end can extend from the male luer. In some embodiments, the enclosed passageway can be disposed within a curved end of the connector. In some embodiments, the connector can include a male luer that is configured to form a seal within the catheter assembly, and the curved end can extend from the male luer.

[0010] In some embodiments, the instrument delivery device can include a directional indicator to indicate to a clinician an orientation of the instrument delivery device relative to the catheter assembly such that the curved portion is configured to direct the instrument in a distal direction within the catheter assembly. In some embodiments, the connector can include an insertion portion and a plurality of arms. In some embodiments, the insertion portion can be configured to be inserted into the catheter assembly. In some embodiments, the plurality of arms can be configured to snap onto an exterior of the catheter assembly.

[0011] In some embodiments, a catheter system can include a catheter adapter that can include a distal end, a proximal end, a lumen extending through the distal end and the proximal end of the catheter adapter, and a side port disposed between the distal end and the proximal end. In some embodiments, the side port can be disposed at 90° relative to a longitudinal axis of the catheter adapter. In some embodiments, the catheter system can include a catheter extending from the distal end of the catheter adapter.

[0012] In some embodiments, the catheter system can include a ring valve disposed within the internal lumen and configured to seal the side port. In some embodiments, the catheter system can include an instrument advancement feature. In some embodiments, the instrument advancement feature can be configured to direct an instrument in a distal direction within the internal lumen of the catheter adapter when the instrument is inserted through the side port.

[0013] In some embodiments, the instrument advancement feature can include a ramp disposed within an interior of the ring valve. In some embodiments, the instrument advancement feature can include an attachment sleeve or adhesive that attaches a proximal end of the ring valve to an internal surface of the catheter adapter. In some embodiments, the instrument advancement feature can include a ramp on an internal surface of the catheter adapter. In some embodiments, the catheter system can include a needleless access connector that can include a first end having a female luer fitting. In some embodiments, the needleless access connector can include a second end coupled to the side port. In some embodiments, the second end of the connector can include an instrument advancement feature. In some embodiments, the instrument advancement feature can include a curved portion, and the curved portion can include a channel or a closed passageway.

[0014] In some embodiments, a catheter system can include a catheter adapter that can include a distal end, a proximal end, an internal lumen extending through the distal end and the proximal end of the catheter adapter, and a side port disposed between the distal end and the proximal end. In some embodiments, the side port can be configured at an angle less than 90° relative to a longitudinal axis of the catheter adapter. In some embodiments, the catheter system can include a catheter extending from the distal end of the catheter adapter. In certain embodiments, the catheter system can include a ring valve disposed within the internal lumen and configured to seal the side port. In some embodiments, the side port can be fixed relative to the distal end of the catheter adapter and the proximal end of the catheter adapter at an angle less than 90° relative to a longitudinal axis of the catheter adapter.

[0015] In some embodiments, the catheter system can include a cap coupled to the side port. In some embodiments, a central axis of the cap can be perpendicular to a longitudinal axis of the catheter adapter. In some embodiments, an internal surface of the cap can include a protrusion that seals the side port. In some embodiments, the side port can include a living hinge. In some embodiments, the side port can include a side port lumen having an asymmetric shape. In some embodiments, the side port can be fixed relative to the distal end of the catheter adapter and the proximal end of the catheter adapter at an angle less than 90° relative to a longitudinal axis of the catheter adapter. In some embodiments, the side port can extend from a top of the catheter adapter. In some embodiments, the catheter system can include a septum disposed within the side port.

[0016] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the application as claimed. It should be understood that various embodiments are not limited to the arrangements and instrumentalities shown in the attached drawings. It should also be understood that the embodiments can be combined or other embodiments utilized, and structural changes made, without departing from the scope of the various embodiments of the present application, unless so claimed. Accordingly, the following detailed description is not intended to limit the scope of the application. BRIEF DESCRIPTION OF DRAWINGS

[0017] The exemplary embodiments will be described in additional detail and explained with the use of accompanying drawings in which:

[0018] FIG. 1A is an upper perspective view of a prior art blood withdrawal device;

[0019] FIG. 1B is an upper perspective view of one end of a prior art blood withdrawal device;

[0020] FIG. 1C is a cross-sectional view of a prior art blood withdrawal device in certain circumstances;

[0021] FIG. 1D is a cross-sectional view of a prior art catheter system;

[0022] Figure 2A is a cross-sectional view of an exemplary catheter system according to some embodiments;

[0023] Figure 2B is a cross-sectional view of a catheter system according to some embodiments coupled to an exemplary device delivery apparatus with an exemplary device in an advanced position;

[0024] Figure 2C is an upper perspective view of an exemplary needleless access connector having an exemplary channel according to some embodiments;

[0025] Figure 2D is a cross-sectional view of a catheter system according to some embodiments including a needleless access connector having a closed passageway;

[0026] Figure 2E is an upper perspective view of a needleless connector having a closed passageway according to some embodiments;

[0027] Figure 3A is a cross-sectional view of a catheter system according to some embodiments including an exemplary connector having a closed passageway;

[0028] Figure 3B is an upper perspective view of a connector having a closed passageway according to some embodiments;

[0029] Figure 3Cis a top perspective view of a connector with a closed passageway according to some embodiments;

[0030] Figure 3D is a cross-sectional view of a catheter system showing an example connector with a closed passageway at a straight end according to some embodiments;

[0031] Figure 4A is a top perspective view of a catheter system showing an example ring valve with a ramp therein according to some embodiments;

[0032] Figure 4B is a distal end view of a ring valve with a ramp therein according to some embodiments;

[0033] Figure 4C is a cross-sectional view of a catheter system showing a ring valve with a slit according to some embodiments;

[0034] Figure 4D is a cross-sectional view of a catheter system showing an example attachment sleeve securing a proximal end of a ring valve according to some embodiments;

[0035] Figure 4E is a cross-sectional view of a catheter system showing an example ramp of an example catheter adapter according to some embodiments;

[0036] Figure 4F is a cross-sectional view of a catheter system showing an example opposing ramp of an example catheter adapter according to some embodiments;

[0037] Figure 5A is a top perspective view of a catheter system showing a side port secured at an angle relative to a longitudinal axis of the catheter system according to some embodiments;

[0038] Figure 5B is a cross-sectional view of a catheter system showing a side port secured at the angle according to some embodiments;

[0039] Figure 5C is a cross-sectional view of a catheter system showing an example cap with an example protrusion according to some embodiments;

[0040] Figure 5D is a cross-sectional view of a catheter system showing a cap with a sloped upper surface according to some embodiments;

[0041] Figure 5E is a top view of an example cap showing an example oblong shape according to some embodiments;

[0042] Figure 5F is a top view of an example cap showing an example square or rectangular shape according to some embodiments;

[0043] Figure 6 is a cross-sectional view of a catheter system showing an example hole in a wall of a catheter adapter, according to some embodiments;

[0044] Figure 7A is a cross-sectional view of a catheter system showing an example side port with a movable joint in a first position, according to some embodiments;

[0045] Figure 7B is a cross-sectional view of a catheter system showing a side port with a movable joint in a second position, according to some embodiments;

[0046] Figure 8A is a top perspective view of a catheter adapter with asymmetric side port lumens, according to some embodiments;

[0047] Figure 8B is a top perspective view of a catheter adapter with asymmetric another side port lumens, according to some embodiments;

[0048] Figure 8C is a top perspective view of a connector with example directional indicators, according to some embodiments;

[0049] Figure 8D is a top perspective view of a catheter adapter showing example directional indicators, according to some embodiments;

[0050] Figure 8E is a top perspective view of a needleless access connector with example directional indicators, according to some embodiments;

[0051] Figure 9A is a cross-sectional view of a catheter system showing an example septum actuator, according to some embodiments;

[0052] Figure 9B is an enlarged cross-sectional view of a portion of a catheter system showing a septum actuator and showing an example cap removed, according to some embodiments;

[0053] Figure 9C is a cross-sectional view of a septum actuator, according to some embodiments;

[0054] Figure 9D is a cross-sectional view of a needleless access connector coupled to a septum actuator, according to some embodiments;

[0055] Figure 9E is a cross-sectional view of a connector coupled to a septum actuator, according to some embodiments;

[0056] Figure 9Fis a cross-sectional view of a catheter system coupled to a connector according to some embodiments;

[0057] Figure 9G is a cross-sectional view of a catheter adapter according to some embodiments, showing an example septum;

[0058] Figure 9H is a cross-sectional view of a catheter system according to some embodiments, showing another example septum;

[0059] FIG. 10A is an upper perspective view of a prior art connector of a prior art blood draw device according to some embodiments;

[0060] Figure 10B is an upper perspective view of a catheter system according to some embodiments, showing a connector having a plurality of arms coupled to a cap;

[0061] Figure 10C is a schematic top view of a connector having a plurality of arms according to some embodiments; and

[0062] Figure 10D is an upper perspective view of a catheter system according to some embodiments, showing a connector having a plurality of arms coupled to a catheter adapter. DETAILED DESCRIPTION

[0063] Referring now to FIGS. 1A-1C, a prior art blood draw device 10 is shown. The prior art blood draw device 10 can correspond to the PIVOGLU® blood collection set available from Becton, Dickinson and Company of Franklin Lakes, New Jersey. TM Needleless blood draw device. The prior art blood draw device 10 advances a flexible flow tube 11 through an indwelling peripheral intravenous catheter and into a blood vessel to collect a blood sample. The prior art blood draw device 10 includes a housing 12 including a proximal end 14, a distal end 16, and a slot 18 disposed between the proximal end 14 of the housing 12 and the distal end 16 of the housing 12.

[0064] The prior art blood draw device 10 includes a connector 20 coupled to the distal end 16 of the housing 12. The prior art blood draw device 10 includes a slider 22 configured to move along the slot 18. The prior art blood draw device 10 includes a flexible flow tube 11 disposed within the housing 12 and coupled to the slider 22. The flexible flow tube 11 can be advanced through the indwelling peripheral intravenous catheter in response to movement of the slider 22 along the slot 18 from the proximal position to the distal position. Blood can be collected through the flexible flow tube 11 when the flexible flow tube 11 is advanced through the indwelling peripheral intravenous catheter and positioned within the blood vessel. In some cases, the flexible flow tube 11 can be advanced beyond a thrombus, valve, or other obstruction, extending to a new source of blood. Thus, the flexible flow tube 11 can allow blood to be collected through the indwelling peripheral intravenous catheter, extending the use of the indwelling peripheral intravenous catheter without the need for further needle sticks. Blood can be collected via an adapter 24 at a proximal end of the flexible flow tube 11. The adapter 24 can correspond to a BD VACUTAINER® ® LUER-LOK TM Access device.

[0065] Referring now to FIG. ID, a prior art catheter system 26 is shown. The prior art catheter system 26 can correspond to a BD VENFLON® TM Pro safety needle protection IV cannula. Currently, the prior art catheter system 26 is not configured for use with the prior art blood draw device 10, and thus blood can not be easily collected from the prior art catheter system 26. The prior art catheter system 26 includes a catheter adapter 28 including a distal end 30, a proximal end 32, a lumen 34 extending through the distal end 30 and the proximal end 32 of the catheter adapter 28, and a side port 36 disposed between the distal end 30 and the proximal end 32 of the catheter adapter 28. The side port 36 is disposed at 90° relative to a longitudinal axis of the catheter adapter 28. The prior art catheter system 26 can include a peripheral intravenous catheter 38 extending from the distal end 30 of the catheter adapter 28. The prior art catheter system 26 can include a ring valve 40 disposed within the lumen 34 and configured to seal the side port 36. A cap 41 is placed over the side port 36. The ring valve 40 is cylindrical and can collapse in all directions.

[0066] Due to the presence of the annular valve 40, it would be difficult to couple the prior art blood withdrawal device 10 to the side port 36 of the prior art catheter system 26 and advance the flexible flow tube 11 through the side port 36 and the peripheral intravenous catheter 38. Moreover, it would be difficult to change the direction of the flexible flow tube 11 inserted into the side port 36 to exit the peripheral intravenous catheter 38 when the flexible flow tube 11 is advanced through the side port 36.

[0067] Reference is now made to Figures 2A-2E In some embodiments, the needleless access connector 42 can facilitate advancement of the instrument 44 within the ported catheter system 46. In some embodiments, the needleless access connector 42 can facilitate a change in direction of the instrument 44 as the instrument 44 is advanced through the needleless access connector 42 so that the instrument 44 can be delivered distally through the catheter 48. In some embodiments, the catheter 48 can comprise a peripheral intravenous catheter, an arterial catheter, a midline catheter, a peripheral inserted central catheter, or another type of catheter.

[0068] In some embodiments, the catheter system 46 can comprise a catheter assembly that can include a catheter adapter 50 and a catheter 48. In some embodiments, the catheter adapter 50 can include a distal end 52, a proximal end 54, a lumen 56 extending through the distal end 52 and the proximal end 54 of the catheter adapter 50, and a side port 58 disposed between the distal end 52 and the proximal end 54. In some embodiments, the side port 58 can be disposed at 90° relative to a longitudinal axis 60 of the catheter adapter 50. In some embodiments, the catheter 48 can extend from the distal end 52 of the catheter adapter 50.

[0069] In some embodiments, the catheter system 46 can be similar or identical to the prior art catheter system 26 of FIG. ID in one or more features and / or operations. In some embodiments, the catheter system 46 can include an annular valve 62 disposed within the lumen 56 and configured to seal the side port 58. In some embodiments, the catheter system 46 can include an instrument advancement feature. In some embodiments, the instrument advancement feature can be configured to direct the instrument 44 in a distal direction within the lumen 56 of the catheter adapter 50 when the instrument 44 is inserted through the side port 58. In some embodiments, the instrument advancement feature can gradually change the direction of the instrument 44 so that the instrument 44 is not damaged.

[0070] In some embodiments, the needleless access connector 42 may include a first end 64 having a female Luer connector. In some embodiments, the needleless access connector 42 may include a second end 66 coupled to a side port 58. In some embodiments, the second end 66 of the needleless access connector 42 may include a device advancement feature. For example, the needleless access connector 42 may include a bent portion configured to change the orientation of the device 44 as it advances through the needleless access connector 42. In some embodiments, the bent portion may be configured to change the orientation of the device 44 by 90° or about 90° (or another desired angle) as the device advances through the needleless access connector 42.

[0071] In some embodiments, device 44 may include a flexible flow tube, guidewire, probe, probe including one or more sensors, or another suitable device for delivery into a patient's vascular system. In some embodiments, when catheter 48 is in place within the vascular system, device advancement features may facilitate movement of device 44 through catheter 48 for blood collection, infusion, removal of blood clots, sensing one or more blood parameters, or another function.

[0072] like Figures 2A-2C As shown, in some embodiments, the curved portion may include a groove 68. In some embodiments, the needleless access connector 42 may include a male Luer connector 70 configured to form a seal within the side port 58, and the groove 68 may extend from the male Luer connector 70. In some embodiments, the outer surface of the male Luer connector 70 may be generally cylindrical or taper inward toward the second end 66 to contact the inner surface of the side port 58 along the length of the male Luer connector 70 and form a seal. In some embodiments, the groove 68 may not be annular. In some embodiments, the groove 68 may extend from the proximal portion of the male Luer connector 70 or be disposed on the proximal portion of the needleless access connector 42. In some embodiments, in response to the needleless access connector 42 being coupled to the side port 58, the groove 68 may depress an annular valve 62, which may facilitate distal advancement of the instrument 44 through the catheter adapter 50 and the catheter 48 into the vascular system.

[0073] In some embodiments, the pinless connector 42 may include a diaphragm 72 disposed within the first end 64. In some embodiments, one or more of the first end 64, the second end 66, and the male Luer connector 70 may be integrally formed as a single unit, or may be separate parts coupled together. In some embodiments, the pinless connector 42 may include an annular collar 74 surrounding the male Luer connector 70. In some embodiments, the inner surface of the annular collar 74 may include barbs 76 configured to insert into holes in the outer surface of the side port 58, which may permanently secure the pinless connector 42 to the side port 58 to maintain sterility. In some embodiments, the inner surface of the annular collar 74 may be threaded to the outer surface of the side port 58, or may engage with the outer surface of the side port 58 in a sliding fit manner.

[0074] In some embodiments, the connector 75 of the device delivery device 77 may be coupled to the first end 64. In some embodiments, the device delivery device 77 may include or correspond to the prior art blood-drawing device 10 in one or more features and / or operations. In some embodiments, the connector 75 may include or correspond to the connector 20 of the prior art blood-drawing device 10 or another connector of another device delivery device for delivering the device to a patient's vascular system.

[0075] like Figures 2D-2E As shown, in some embodiments, the bend may include a closed passage 78. In some embodiments, the closed passage 78 may be disposed within the bend end of the needleless access connector 42, which may correspond to the second end 66. In some embodiments, the bend end may include an annular bend outer surface. In some embodiments, the needleless access connector 42 may include a male Luer connector 70 configured to form a seal within the side port 58, and the bend end may extend from the male Luer connector 70. In some embodiments, the diameter of the closed passage 78 may be smaller than the diameter of the male Luer connector 70. Therefore, in some embodiments, a stepped surface may exist between the bend and the male Luer connector 70. In some embodiments, in response to the needleless access connector 42 being coupled to the side port 58, the closed passage 78 may depress an annular valve 62, which may facilitate distal advancement of the instrument 44 through the catheter adapter 50 and the catheter 48 into the vascular system.

[0076] Now for reference Figures 3A-3D In some embodiments, connector 75 itself may facilitate device 44 (e.g., see...). Figure 2DAdvancement within the ported catheter system 46. In some embodiments, connector 75 may include or correspond to connector 20 of the prior art blood-drawing device 10 or another connector of another device delivery device for delivering the device to a patient's vascular system. In some embodiments, as the device 44 advances through connector 75, connector 75 may facilitate a change in the orientation of the device 44, such that the device 44 may be delivered distally through catheter 48.

[0077] In some embodiments, connector 75 may include opposing lever arms 79a, 79b. In some embodiments, the distal ends of opposing lever arms 79a, 79b may be configured to move apart from each other in response to pressure applied to the proximal ends of opposing lever arms 79a, 79b. In some embodiments, in response to the removal of pressure applied to the proximal ends of opposing lever arms 79a, 79b, the distal ends may move closer together and clamp a portion of a catheter assembly, such as a needleless connector, another connector, or side port 58.

[0078] In some embodiments, connector 75 may include a bent portion configured to change the orientation of instrument 44 as it advances past connector 20. In some embodiments, the bent portion may correspond to an instrument advance feature. In some embodiments, the bent portion may be configured to change the orientation of the instrument by 90° or about 90° (or another desired angle) as it advances past connector 75. In some embodiments, the bent portion may include a groove similar to... Figures 2A-2C Groove 68.

[0079] For example, such as Figures 3A-3D As shown, in some embodiments, the bent portion of connector 75 may include a closed passage 80. In some embodiments, the closed passage 80 may be disposed within the bent end 82 of connector 75 having an annular bent outer surface. In some embodiments, when connector 75 is coupled to side port 58, the bent end 82 may press down an annular valve 62, which may facilitate the device 44 (e.g., see...). Figure 2D The catheter advances distally through catheter adapter 50 and catheter 48 into the vascular system. In some embodiments, when connector 75 is engaged with side port 58, opposing lever arms 79a, 79b may hook onto side port 58, the cap of side port 58, or another feature. In some embodiments, opposing lever arms 79a, 79b may be on opposite sides of longitudinal axis 60, which may facilitate the clinician to clamp opposing lever arms 79a, 79b.

[0080] For example, such as Figure 3DAs shown, in some embodiments, a closed passage 80 may be disposed within the straight end 84 of the connector 75. In some embodiments, the closed passage 80 may exit the connector 75 at a side hole in the straight end 84. In some embodiments, the connector 75 may include a male Luer connector 86 configured to form a seal within a side port 58, and the straight end 84 may extend from the male Luer connector 86. In some embodiments, the connector 75 may include a male Luer connector 86 configured to form a seal within a side port 58, and Figures 3A-3D The bent end 82 may extend from the male Luer connector 86. In some embodiments, in response to the connector 75 being engaged to the side port 58, the straight end 84 may depress the annular valve 62, which may facilitate the distal advancement of the instrument 44 through the catheter adapter 50 and the catheter 48 into the vascular system.

[0081] Now for reference Figures 4A-4B In some embodiments, the instrument advance feature may include a ramp 88 disposed within the annular valve 62. In some embodiments, the proximal end 90 of the ramp 88 may be higher or thicker than the distal end 92 of the ramp 88, such that in response to an instrument 44 inserted through the side port 58 (e.g., see...), the device advance feature may be... Figure 2D The proximal end of the annular valve 62 can be depressed less than the distal end of the annular valve 62. Therefore, the ramp 88 can facilitate the entry of the instrument 44 into the lumen 56 at the distal end of the annular valve 62 and its movement toward the distal end of the catheter system 46. In some embodiments, the upper surface of the ramp 88 can be smooth or planar, which can facilitate the movement of the instrument 44 on the annular valve 62 and the ramp 88. In some embodiments, the ramp 88 can be integrally formed as a single unit with the annular valve 62.

[0082] Now for reference Figure 4C In some embodiments, the annular valve 62 may include a slit 94, such that the device 44 (e.g., see...) Figure 2D The instrument 44 can be inserted into the lumen 56 through the slit 94 and advanced distally. In some embodiments, the slit 94 creates a passage for the instrument 44 to enter the lumen 56.

[0083] Now for reference Figure 4D In some embodiments, the device advancement feature may include an attachment sleeve 96 that attaches the proximal end of the annular valve 62 to the inner surface 98 of the catheter adapter 50. In some embodiments, the inner surface 98 may form an inner cavity 56. In some embodiments, the attachment sleeve 96 may be annular. In some embodiments, the attachment sleeve 96 may be coupled to the inner surface 98 and / or the proximal end of the annular valve 62 via an adhesive or another attachment mechanism. In some embodiments, the annular valve 62 and / or the attachment sleeve 96 may be made of silicone, plastic, or another suitable material. In some embodiments, when the device 44 (e.g., see...)Figure 2D When the annular valve 62 is contacted from the side port 58, the attachment sleeve 96 can cause the annular valve 62 to collapse toward its distal end. In some embodiments, collapsing the distal end of the annular valve 62 in this manner can form a ramp to guide the instrument 44 distally into the lumen 56 and facilitates turning from the side port 58.

[0084] In some embodiments, instead of the attachment sleeve 96, an adhesive applied to the proximal end of the annular valve 62 can adhere the proximal end of the annular valve 62 to the inner surface 98 and cause the annular valve 62 to collapse toward the distal end of the annular valve 62 when the instrument contacts the annular valve 62 from the side port 58, thereby ensuring that the instrument 44 passes distally through the catheter assembly.

[0085] Now for reference Figure 4E In some embodiments, the device advancement feature may include a ramp 100 on the inner surface 98 of the catheter adapter 50. In some embodiments, the proximal end 102 of the ramp 100 may be higher or thicker than the distal end 104 of the ramp 100. In some embodiments, the upper surface of the ramp 100 may be planar or smooth to facilitate the device 44 (e.g., see...). Figure 2D Movement on ramp 100. In some embodiments, the proximal end 102 of ramp 100 may be aligned with or near the proximal sidewall 106 of side port 58, so that instrument 44 is not trapped near ramp 100. In some embodiments, ramp 100 may be spaced apart from the opposing wall of catheter adapter 50, which may facilitate the free passage of fluid, tubing or other devices from the proximal end 54 of catheter adapter 50.

[0086] In some embodiments, one or more protrusions 97 extending toward the central axis of the side port 58 may be removed (e.g., see...). Figure 4D This ensures that when the instrument 44 enters the inner cavity 56 from the side port 58, the instrument 44 will not be stuck by the protrusion 97.

[0087] Now for reference Figure 4F In some embodiments, ramp 88 may be located at the bottom of annular valve 62 or on the side of annular valve 62 away from side port 58. In some embodiments, ramp 88 may be a first ramp, and a second ramp 89 may be positioned opposite the first ramp within annular valve 62. In some embodiments, the shape of the first ramp may be similar to that of the second ramp 89, such that the first ramp and the second ramp 89 are symmetrical within annular valve 62. The first ramp and the second ramp 89 may be spaced apart to allow fluid, tubing, or another device to pass through the proximal end 54 of conduit adapter 50.

[0088] It should be understood that these embodiments can be combined. For example, Figure 4F The annular valve 62 shown can be connected toFigure 4D In some embodiments, the slit 94 can extend through the annular valve 62 and the second ramp 89. In some embodiments, the first ramp and / or the second ramp 89 can be integrally formed with the annular valve 62 as a single unit.

[0089] Referring now to Figures 5A-5E In some embodiments, the side port 58 can be fixed relative to the distal end 52 of the catheter adapter 50 and the proximal end 54 of the catheter adapter 50 at an angle less than 90° relative to the longitudinal axis 60 of the catheter adapter 50. For example, the side port 58 can be fixed relative to the distal end 52 of the catheter adapter 50 and the proximal end 54 of the catheter adapter 50 at an angle of 60°, 45°, 50°, 25°, or another suitable angle relative to the longitudinal axis 60 of the catheter adapter 50. In more detail, a central axis of the side port 58 can be fixed relative to the distal end 52 of the catheter adapter 50 and the proximal end 54 of the catheter adapter 50 at an angle of 60°, 45°, 50°, 25°, or another suitable angle relative to the longitudinal axis 60 of the catheter adapter 50. In some embodiments, the catheter adapter 50 can be integrally formed as a single unit and / or constructed of a rigid material (e.g., rigid plastic).

[0090] In some embodiments, the catheter system 46 can include a cap 108 coupled to the side port 58. In some embodiments, the cap 108 can include a base 110 and an annular collar 112 extending from the base 110. In some embodiments, a central axis 114 of the cap 108 can be perpendicular to the longitudinal axis 60 of the catheter adapter 50. In some embodiments, an inner surface of the base 110 of the cap 108 can include a protrusion 116 that seals the side port 58. In some embodiments, because the outer surface of the cap 108 is straight or symmetric about the central axis 114 that is perpendicular to the longitudinal axis 60, the cap 108 can facilitate gripping during insertion of the catheter 48 into a patient. In some embodiments, the interior of the cap 108 can be non-symmetrical due to the protrusion 116.

[0091] In some embodiments, the side port 58 can be positioned on a top of the catheter adapter 50, or on a side that is farthest from the patient's skin, when the catheter system 46 is inserted into the patient's vasculature. In some embodiments, the side port 58 disposed on the top of the catheter adapter 50 can provide access for an instrument 44 (e.g., see FIG. 1) to access the catheter 48 without having to reach around the catheter adapter 50. Figure 2Deasy access into the vasculature through the catheter adapter 50. In some embodiments, the catheter system 46 can include a needle hub 118 and an introducer needle 120 extending distally from the needle hub 118. In some embodiments, the introducer needle 120 can include a sharp distal tip configured to pierce the skin and vasculature of a patient to insert the catheter 48 through the skin and into the vasculature. In some embodiments, the introducer needle 120 can include a bevel 122 forming the sharp distal tip, which can face upward, or toward the top of the catheter system 46, in an insertion position ready for insertion into a patient, for example, as shown in Figure 5A

[0092] In some embodiments, the base 110 of the cap 108 can be ramped or inclined in a distal direction, for example, as shown in Figures 5E-5F More particularly, the inclined upper surface of the base 110 can provide a push feature on which a clinician can push distally when inserting the catheter system 46 into a patient. In some embodiments, the perimeter of the cap 108 can be non-circular, such as oval, square, or rectangular, which can help the cap 108 cover the side port 58 disposed at an angle. In these embodiments, the perimeter or shape of the cap 108 can facilitate gripping during insertion of the catheter 48 into a patient while still allowing the cap 108 to cover the side port 58. Figures 7A-7B

[0093] In some embodiments, the side port 58 includes a living hinge (see, for example, Figure 6 ), such as a hinge, ball and socket, cylindrical sleeve, which can facilitate movement of the side port 58 from a straight position perpendicular to the longitudinal axis 60 to a position angled relative to the longitudinal axis 60. In these and other embodiments, the outer surface of the catheter adapter 50 distal of the side port 58 can include a push tab that can be grasped to facilitate insertion of the catheter 48 into a patient.

[0094] Referring now to Figure 2D In some embodiments, the catheter adapter 50 can not include a side port 58 that can provide direct access for the instrument 44 to the lumen 56 (see, for example, Figures 7A-7B In these embodiments, the top of the catheter adapter 50 can include a planar and / or smooth surface that can include a hole therethrough. In some embodiments, the hole can be aligned with and proximate to the annular valve 62.

[0095] Referring now to Figure 7A In some embodiments, the side port 58 can include a living hinge 124 that can move between a straight position (see, for example, Figure 7B and an angled position (see, for example,​​Figure 7B In some embodiments, for example, the articulating joint 124 can be locked in a straight position and / or an angled position to prevent the articulating joint 124 from moving during insertion of the catheter 48 into a patient. In some embodiments, the articulating joint 124 can be moved to an angled position to facilitate delivery of the instrument 44 through the side port 58 and distally through the catheter 48. In some embodiments, when the articulating joint 124 is in the angled position, the side port 58 can be pointed proximally and at an angle of less than 90° relative to the longitudinal axis 60 of the catheter adapter 50.

[0096] In some embodiments, the articulating joint 124 can include a ball and socket or a cylindrical sleeve. In more detail, in some embodiments, the articulating joint 124 can include a ball portion that can include a substantially spherical outer surface. In some embodiments, the ball portion can be configured to rotate within a socket that can include a substantially spherical inner surface. In some embodiments, the ball portion and the socket can fit together tightly to prevent fluid leakage through the articulating joint 124.

[0097] In some embodiments, a portion of the side port lumen 125 that extends through the ball portion can be shaped so that the instrument 44 does not get stuck or trapped when the instrument 44 is inserted through the side port 58. For example, as shown in Figures 8A-8B the distal edge of this portion of the side port lumen 125 can be aligned with or proximate to the distal end of the bore through the catheter adapter 50 so that no protrusion is formed that the instrument 44 can get stuck on when the articulating joint 124 is in the angled position.

[0098] In some embodiments, rather than a ball portion, the articulating joint 124 can include a cylindrical portion. In some embodiments, the cylindrical portion can be configured to rotate within a sleeve that can be substantially cylindrical. For more details on exemplary ball and socket or cylindrical sleeve, see U.S. Patent No. 11,590,323, filed May 4, 2020, entitled “Catheter Assembly Support Device, System, and Method,” which is incorporated by reference herein in its entirety.

[0099] In some embodiments, the side port 58 can be constructed of a material that is thinner and / or more flexible than the rest of the catheter adapter 50, which will allow the side port 58 to flex from the first angle to the second angle relative to the longitudinal axis 60 of the catheter adapter 50.

[0100] Reference is now made to Figures 3A-3CIn some embodiments, the side port 58 can include a side port lumen 125 having an asymmetric shape. In some embodiments, all or a portion of the side port lumen 125 can include an asymmetric shape. In these embodiments, the side port lumen 125 can facilitate positioning of the connector 75 of the instrument delivery device 77 (see, e.g., Figure 8C ) in a desired orientation such that the instrument advancement feature directs the instrument 44 distally into the lumen of the catheter adapter 50. Thus, the asymmetric shape can facilitate a "lock and key" type fit between the instrument delivery device 77 and the side port 58. In some embodiments, the asymmetric shape can include an oval, a triangle, a diamond, or another suitable shape.

[0101] Referring now to Figure 8D In some embodiments, the instrument delivery device 77 can include a directional indicator 126 to indicate to the clinician the orientation of the instrument delivery device 77 relative to the catheter assembly such that the curved portion or other instrument advancement feature is configured to direct the instrument in a distal direction within the catheter assembly. In some embodiments, the directional indicator 126 can include an arrow or another suitable indicator. In some embodiments, the arrow or other suitable indicator can point toward the catheter 48 or catheter assembly. In some embodiments, a particular directional indicator 126 on the side port 58 or catheter assembly can be configured to mate or align with another particular directional indicator 126 on the instrument delivery device 77 to indicate the correct orientation of the instrument delivery device 77 relative to the side port 58 or catheter assembly. In some embodiments, the particular directional indicator 126 can include a first color and the other particular directional indicator 126 can include a second color, e.g., the second color can be a different shade than the first color.

[0102] Referring now to Figure 8E In some embodiments, the catheter adapter 50 can include a directional indicator 126 to indicate to the clinician the orientation of the instrument delivery device 77 relative to the catheter assembly such that the curved portion or other instrument advancement feature is configured to direct the instrument in a distal direction within the catheter assembly.

[0103] Referring now to Figures 9A-9C In some embodiments, the needleless access connector 42 can include a directional indicator 126 to indicate to the clinician the orientation of the instrument delivery device 77 relative to the catheter assembly such that the curved portion or other instrument advancement feature is configured to direct the instrument in a distal direction within the catheter assembly.

[0104] Referring now to Figures 9D-9FIn some embodiments, a split septum 128 and / or a septum actuator 130 can be disposed within the side port 58. In these and other embodiments, the annular valve 62 can not be disposed. In some embodiments, a spring 134 can be coupled to the septum actuator 130 and configured to return the septum actuator 130 from the second position to the first position after the medical device is removed from the side port 58. Thus, the septum actuator 130 can be used multiple times. In some embodiments, the septum actuator 130 can advance through the split septum 128 to open the split septum 128 in response to the medical device being coupled to the side port 58. In some embodiments, the medical device can include an instrument delivery device 77 or another suitable medical device. In some embodiments, the split septum 128 can prevent backflow of blood or medication when the side port 58 is in a non-use state.

[0105] Referring now to Figure 9F In some embodiments, the septum actuator 130 can be coupled to the needleless access connector 42 or the connector 75. In some embodiments, the septum actuator 130 can be coupled to the needleless access connector 42 or the connector 75 by adhesive, interference fit, or other suitable method. In these embodiments, the septum actuator 130 can be inserted into the side port 58 in response to the needleless access connector 42 or the connector 75 being coupled to the side port 58. In some embodiments, for example, as shown in Figure 9G the septum actuator 130 can be inserted through the split septum 128 to open the split septum 128 in response to the needleless access connector 42 or the connector 75 being coupled to the side port 58.

[0106] In some embodiments, the septum actuator 130 can include an internal step and an end of a long nose or insertion portion of the connector 75 can abut the internal step. In some embodiments, coupling of the septum actuator 130 with the needleless access connector 42 or the connector 75 can reduce the need for venous compression during insertion and blood withdrawal, thereby reducing the risk of blood exposure.

[0107] Referring now to Figure 9H In some embodiments, a septum 136 can be disposed at an end of the side port 58. In some embodiments, the septum 136 can include a split septum having a slit therethrough. In some embodiments, the septum 136 can cover an end of the side port 58 and / or be disposed within the side port lumen 125 in an interference fit. In some embodiments, the side port 58 can include an annular protrusion configured to receive opposing lever arms of a connector. Referring now to Figures 10B-10D In some embodiments, the septum 136 can be disposed within the side port lumen 125 and / or spaced apart from an end of the side port 58. In some embodiments, the septum 136 can prevent microorganisms from entering.

[0108] Figure 10A shows the connector 20 of a prior art blood-drawing device 10. Now refer to... Figure 10B In some embodiments, connector 75 may include a long nose or insertion portion 138 and a plurality of arms 140. In some embodiments, insertion portion 138 may be configured to insert into and / or form a seal with catheter adapter 50. In some embodiments, the plurality of arms 140 may be configured to engage with or snap onto the exterior of the catheter assembly, such as cap 108 (e.g., see...). Figure 10D ) or conduit adapter 50 (for example, see ​ In some embodiments, the plurality of arms 140 may snap onto an annular connector of cap 108, which connects cap 108 to side port 58. In some embodiments, the end of each of the plurality of arms 140 may include a flange 142 to facilitate snapping onto cap 108 or conduit adapter 50.

[0109] In some embodiments, the plurality of arms 140 may include three arms. In some embodiments, the plurality of arms 140 may include more than three arms. In some embodiments, a tether for the cap 108 may extend between the annular connector and a cover portion of the cap 108 configured to cover and / or seal the opening. In some embodiments, the tether may extend between two arms of the plurality of arms 140, which may be coupled to the same side of the catheter adapter 50. In these and other embodiments, a single arm of the plurality of arms 140 may be coupled to a side of the catheter adapter 50 opposite to the two arms. In some embodiments, the single arm may be positioned between the two arms to provide stability for the connection between the connector 20 and the catheter adapter 50.

[0110] All examples and conditional language described herein are intended for pedagogical purposes to aid the reader's understanding of the invention and the concepts contributed by the inventors to further advance the field, and should be construed as not being limited to these specifically described examples and conditions. Although embodiments of the invention have been described in detail, it should be understood that various changes, substitutions, and modifications can be made thereto without departing from the spirit and scope of the invention.

Claims

1. An instrument delivery device for inserting an instrument through a catheter assembly, the instrument delivery device comprising: a housing comprising a proximal end, a distal end, and a slot disposed between the proximal end of the housing and the distal end of the housing; a connector coupled to the distal end of the housing; a slider configured to move along the slot; and an instrument disposed within the housing and coupled to the slider, wherein the instrument is configured to advance beyond the connector in response to movement of the slider along the slot from a proximal position to a distal position, wherein the connector comprises a curved portion configured to change a direction of the instrument as the instrument is advanced through the connector. the curved portion is configured to change the direction of the instrument by 90° as the instrument is advanced through the connector.

2. The device delivery apparatus of claim 1, wherein, the curved portion comprises a channel.

3. The device delivery apparatus of claim 1, wherein, the curved portion comprises a closed passageway.

4. The device delivery apparatus of claim 1, wherein, the closed passageway is disposed within a straight end of the connector.

5. The device delivery apparatus of claim 4, wherein, the connector comprises a male luer that is configured to form a seal within the catheter assembly, wherein the straight end extends from the male luer.

6. The device delivery apparatus of claim 5, wherein, the closed passageway is disposed within a curved end of the connector.

7. The device delivery apparatus of claim 4, wherein, the connector comprises a male luer that is configured to form a seal within the catheter assembly, wherein the curved end extends from the male luer.

8. The device delivery apparatus of claim 7, wherein, the instrument delivery device further comprises a directional indicator that indicates to a clinician an orientation of the instrument delivery device relative to the catheter assembly such that the curved portion is configured to direct the instrument in a distal direction within the catheter assembly.

9. The device delivery apparatus of claim 1, wherein, the connector comprises an insertion portion and a plurality of arms, wherein the insertion portion is configured to be inserted into the catheter assembly, wherein the plurality of arms are configured to snap onto an exterior of the catheter assembly.

10. The device delivery apparatus of claim 1, wherein, 11. A catheter system comprising: a catheter adapter comprising a distal end, a proximal end, a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter, and a side port disposed between the distal end of the catheter adapter and the proximal end of the catheter adapter; a catheter extending from the distal end of the catheter adapter; a ring valve disposed within the lumen and configured to seal the side port; and an instrument advancement feature, wherein the instrument advancement feature is configured to direct an instrument in a distal direction within the lumen of the catheter adapter when the instrument is inserted through the side port. the instrument advancement feature comprises a ramp disposed within an interior of the ring valve. the instrument advancement feature comprises an attachment sleeve or adhesive that attaches a proximal end of the ring valve to an interior surface of the catheter adapter.

12. The catheter system of claim 11, wherein, the instrument advancement feature comprises a ramp on an interior surface of the catheter adapter.

13. The catheter system of claim 11, wherein, the catheter system further comprises a needleless access connector comprising:

14. The catheter system of claim 11, wherein, a first end comprising a female luer; and 15. The catheter system of claim 11, wherein, a second end comprising a male luer. ​ a second end coupled to the side port, wherein the second end includes the instrument advancement feature, wherein the instrument advancement feature includes a curved portion, wherein the curved portion includes a channel or a closed passageway.

16. A catheter system comprising: a catheter adapter including a distal end, a proximal end, a lumen extending through the distal end and the proximal end of the catheter adapter, and a side port disposed between the distal end and the proximal end of the catheter adapter, wherein the side port is configured at an angle less than 90° relative to a longitudinal axis of the catheter adapter; a catheter extending from the distal end of the catheter adapter; and a ring valve disposed within the lumen and configured to seal the side port.

17. The catheter system of claim 16, wherein, the side port is fixed relative to the distal end of the catheter adapter and a proximal end of the catheter at an angle less than 90° relative to a longitudinal axis of the catheter adapter, the catheter system further comprising a cap coupled to the side port, wherein a central axis of the cap is perpendicular to the longitudinal axis of the catheter adapter, wherein an inner surface of the cap includes a protrusion that seals the side port.

18. The catheter system of claim 16, wherein, the side port includes a living hinge.

19. The catheter system of claim 16, wherein, the side port includes a side port lumen having an asymmetric shape.

20. The catheter system of claim 16, wherein, the side port is fixed relative to the distal end of the catheter adapter and the proximal end of the catheter adapter at an angle less than 90° relative to a longitudinal axis of the catheter adapter, wherein the side port extends from a top of the catheter adapter, the catheter system further comprising a septum disposed within the side port.

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