Instrument delivery device and catheter system

Abstract

An instrument delivery device for inserting an instrument through a catheter assembly may include a housing, a connector coupled to the housing, a slider configured to move along a slot of the housing, and an instrument 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 configured to change the direction of the instrument when the instrument is advanced through the connector. A catheter system may include a catheter adapter, which may include a side port. An annular valve may be disposed within the inner cavity and configured to seal the side port. The catheter system may include an instrument advancement feature configured to guide an instrument in a distal direction within the lumen of the catheter adapter such that the instrument is not damaged.

Description

Technical Field

[0001] This disclosure generally relates to an instrument delivery device and a catheter system. Background Technology

[0002] Catheters are commonly used to deliver fluids into a patient's vascular system. For example, catheters can be used to infuse saline solutions, various medications, or total parenteral nutrition. Catheters can also be used to draw blood from a patient.

[0003] The catheter may include a needle-type intravenous (“IV”) catheter. In this case, the catheter may be mounted on a guide needle with a sharp distal end. The catheter and guide needle may be assembled such that the distal end of the guide needle extends beyond the distal end of the catheter, with the bevel face 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.

[0004] To verify proper placement of the guide needle and / or catheter in a blood vessel, clinicians typically confirm the presence of a "flashback" of blood in the flashback chamber of the catheter assembly, including the catheter. Once needle placement is confirmed, clinicians may temporarily occlude flow in the vascular system and remove the needle, leaving the catheter in place for future blood draws or fluid infusions.

[0005] Blood sampling using catheters can be difficult for several reasons, especially when the catheter is left in place for more than a day. For example, when a catheter is inserted into a patient for an extended period, the catheter or vein may be more prone to narrowing, collapsing, twisting, becoming clogged with debris (e.g., fibrin or platelet clots), and the catheter tip may become lodged in the vascular system. Therefore, catheters can be frequently used to collect blood samples during catheter placement, but much less frequently during catheter indwelling. Consequently, when blood samples are needed, an additional needle prick is required to provide venous access for blood sampling, which can be painful for the patient and results in higher material costs. Therefore, there is a need for catheter systems, devices, and methods that facilitate the placement of instruments (e.g., flexible flow tubing or probes for blood sampling) into a patient's vascular system without the need for an additional needle prick.

[0006] The subject matter claimed herein is not limited to embodiments that address any shortcomings or work only in environments such as those described above. Rather, this background is provided merely to illustrate an example technical field in which some of the implementations described herein can be practiced. Utility Model Content

[0007] In some embodiments, this disclosure generally relates to a device delivery device and / or catheter system for facilitating the delivery of a device into a patient's vascular system. In some embodiments, this disclosure generally relates to a connector for facilitating the delivery of a device into a patient's vascular system. In some embodiments, this disclosure generally relates to a method for facilitating the delivery of a device into a patient's vascular system.

[0008] In some embodiments, a device delivery device for inserting a device through a catheter assembly includes: a housing including a proximal end, a distal end, and a slot disposed between the proximal end 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 a device disposed within the housing and coupled to the slider, wherein the device 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 includes a bend configured to change the orientation of the device as it is advanced through the connector.

[0009] In some embodiments, a device delivery device for inserting an instrument through a catheter assembly may include a housing. In some embodiments, the housing may include a proximal end, a distal end, and a slot disposed between the proximal end and the distal end of the housing. In some embodiments, the device delivery device may include a connector coupled to the distal end of the housing. In some embodiments, the device delivery device may include a slider configured to move along the slot. In some embodiments, the device delivery device may include an instrument disposed within the housing and coupled to the slider.

[0010] In some embodiments, the device 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. In some embodiments, the connector may include a bend configured to change the orientation of the device as it advances past the connector. In some embodiments, the device may include a flexible flow tube configured to extend through an indwelling catheter for blood collection. In some embodiments, the bend may be configured to change the orientation of the device by 90° as it advances past the connector. In some embodiments, the bend may include a groove. In some embodiments, the bend may include a closed passage.

[0011] In some embodiments, a closed passage may be provided within the straight end of the connector. In some embodiments, the connector may include a male Luer connector configured to form a seal within the conduit assembly, and the straight end may extend from the male Luer connector. In some embodiments, a closed passage may be provided within the bent end of the connector. In some embodiments, the connector may include a male Luer connector configured to form a seal within the conduit assembly, and the bent end may extend from the male Luer connector.

[0012] In some embodiments, the device delivery device may include a orientation indicator to indicate to a clinician the orientation of the device delivery device relative to the catheter assembly, such that the curved portion is configured to guide the device distally within the catheter assembly. In some embodiments, the connector may include an insertion portion and a plurality of arms. In some embodiments, the insertion portion may be configured to insert into the catheter assembly. In some embodiments, the plurality of arms may be configured to snap onto the exterior of the catheter assembly.

[0013] In some embodiments, a catheter system includes: a catheter adapter including a distal end, a proximal end, an inner 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; a catheter extending from the distal end of the catheter adapter; an annular valve disposed within the inner lumen and configured to seal the side port; and a device advancement feature, wherein, when a device is inserted through the side port, the device advancement feature is configured to guide the device in a distal direction within the inner lumen of the catheter adapter.

[0014] In some embodiments, a catheter system may include a catheter adapter, the catheter adapter including a distal end, a proximal end, an inner lumen extending through the distal and proximal ends of the catheter adapter, and a side port disposed between the distal and proximal ends. In some embodiments, the side port may be configured at 90° relative to the longitudinal axis of the catheter adapter. In some embodiments, the catheter system may include a catheter extending from the distal end of the catheter adapter.

[0015] In some embodiments, the catheter system may include an annular valve disposed within the lumen and configured to seal the side port. In some embodiments, the catheter system may include a device advancement feature. In some embodiments, when a device is inserted through the side port, the device advancement feature may be configured to guide the device distally within the lumen of the catheter adapter.

[0016] In some embodiments, the device advancement feature may include a ramp disposed within the interior of the annular valve. In some embodiments, the device advancement feature may include an attachment sleeve or adhesive for attaching the proximal end of the annular valve to the inner surface of the catheter adapter. In some embodiments, the device advancement feature may include a ramp on the inner surface of the catheter adapter. In some embodiments, the catheter system may include a needleless access connector, which may include a first end having a female Luer connector. In some embodiments, the needleless access connector may include a second end coupled to a side port. In some embodiments, the second end of the connector may include a device advancement feature. In some embodiments, the device advancement feature may include a curved portion, and the curved portion may include a groove or a closed passage.

[0017] In some embodiments, a catheter system includes: a catheter adapter including a distal end, a proximal end, an inner 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 of less than 90° relative to the longitudinal axis of the catheter adapter; a catheter extending from the distal end of the catheter adapter; and an annular valve disposed within the inner lumen and configured to seal the side port.

[0018] In some embodiments, a catheter system may include a catheter adapter, the catheter adapter including a distal end, a proximal end, an inner lumen extending through the distal and proximal ends of the catheter adapter, and a side port disposed between the distal and proximal ends. In some embodiments, the side port may be configured at an angle of less than 90° relative to the longitudinal axis of the catheter adapter. In some embodiments, the catheter system may include a catheter extending from the distal end of the catheter adapter. In some embodiments, the catheter system may include an annular valve disposed within the inner lumen and configured to seal the side port. In some embodiments, the side port may be fixed relative to the distal and proximal ends of the catheter adapter at an angle of less than 90° relative to the longitudinal axis of the catheter adapter.

[0019] In some embodiments, the catheter system may include a cap coupled to a side port. In some embodiments, the central axis of the cap may be perpendicular to the longitudinal axis of the catheter adapter. In some embodiments, the inner surface of the cap may include a protrusion that seals the side port. In some embodiments, the side port may include a movable connector. In some embodiments, the side port may include a side port lumen having an asymmetrical shape. In some embodiments, the side port may be fixed at an angle of less than 90° relative to the distal and proximal ends of the catheter adapter with respect to the longitudinal axis of the catheter adapter. In some embodiments, the side port may extend from the top of the catheter adapter. In some embodiments, the catheter system may include a diaphragm disposed within the side port.

[0020] It should be understood that the foregoing general description and the following detailed description are exemplary and explanatory, and not intended to limit the scope of the claimed invention. It should be understood that the various embodiments are not limited to the arrangements and tools shown in the accompanying drawings. It should also be understood that embodiments may be combined, other embodiments may be utilized, and structural changes may be made without departing from the scope of the various embodiments of the invention, unless so claimed. Therefore, the following detailed description is not intended to be limiting. Attached Figure Description

[0021] Exemplary embodiments will be described and explained with additional specificity and detail using the accompanying drawings, wherein:

[0022] Figure 1A This is a top perspective view of an existing blood-drawing device;

[0023] Figure 1B This is a top perspective view of one end of a conventional blood-drawing device;

[0024] Figure 1C This is a cross-sectional view of a conventional blood-drawing device under certain conditions;

[0025] Figure 1D This is a cross-sectional view of a prior art conduit system;

[0026] Figure 2A This is a cross-sectional view of an exemplary catheter system according to some embodiments;

[0027] Figure 2B This is a cross-sectional view of a catheter system according to some embodiments, the catheter system being coupled to an exemplary instrument delivery device, wherein the exemplary instrument is in the forward position;

[0028] Figure 2C This is a top perspective view of an exemplary pinless connector with exemplary grooves according to some embodiments;

[0029] Figure 2DThis is a cross-sectional view of a catheter system according to some embodiments, the catheter system including a needleless access connector with a closed passage;

[0030] Figure 2E This is a top perspective view of a pinless connector with a closed passage according to some embodiments;

[0031] Figure 3A This is a cross-sectional view of a catheter system according to some embodiments, the catheter system including an exemplary connector having a closed passage;

[0032] Figure 3B This is a top perspective view of a connector with a closed passage according to some embodiments;

[0033] Figure 3C This is a top perspective view of a connector with a closed passage according to some embodiments;

[0034] Figure 3D This is a cross-sectional view of a catheter system according to some embodiments, showing an exemplary connector with a closed passage at the straight end;

[0035] Figure 4A This is a top perspective view of a catheter system according to some embodiments, showing an exemplary annular valve having a ramp therein;

[0036] Figure 4B This is a distal view of an annular valve having a ramp, according to some embodiments;

[0037] Figure 4C This is a cross-sectional view of a conduit system according to some embodiments, showing an annular valve with a slit;

[0038] Figure 4D This is a cross-sectional view of a conduit system according to some embodiments, showing an exemplary attachment sleeve at the proximal end of a fixed annular valve;

[0039] Figure 4E This is a cross-sectional view of a catheter system according to some embodiments, showing an exemplary ramp of an exemplary catheter adapter;

[0040] Figure 4F This is a cross-sectional view of a catheter system according to some embodiments, showing an exemplary relative ramp of an exemplary catheter adapter;

[0041] Figure 5A This is a top perspective view of a catheter system according to some embodiments, showing a side port fixed at an angle relative to the longitudinal axis of the catheter system.

[0042] Figure 5BThis is a cross-sectional view of a catheter system according to some embodiments, showing a side port fixed at the stated angle;

[0043] Figure 5C This is a cross-sectional view of a catheter system according to some embodiments, showing an exemplary cap with exemplary protrusions;

[0044] Figure 5D This is a cross-sectional view of a conduit system according to some embodiments, showing a cap with an inclined upper surface;

[0045] Figure 5E This is a top view of an exemplary cap according to some embodiments, showing an exemplary elliptical shape;

[0046] Figure 5F This is a top view of an exemplary cap according to some embodiments, showing an exemplary square or rectangular shape;

[0047] Figure 6 This is a cross-sectional view of a conduit system according to some embodiments, showing exemplary holes in the wall of a conduit adapter;

[0048] Figure 7A This is a cross-sectional view of a catheter system according to some embodiments, showing an exemplary side port with an active connector in a first position;

[0049] Figure 7B This is a cross-sectional view of a catheter system according to some embodiments, showing a side port with an active connector in a second position;

[0050] Figure 8A This is a top perspective view of a catheter adapter with an asymmetrical side port lumen according to some embodiments;

[0051] Figure 8B This is a top perspective view of a catheter adapter having an asymmetrical lumen on the other side of the port, according to some embodiments;

[0052] Figure 8C This is a top perspective view of a connector having an exemplary direction indicator according to some embodiments;

[0053] Figure 8D This is a top perspective view of a catheter adapter according to some embodiments, showing an exemplary direction indicator;

[0054] Figure 8E This is a top perspective view of a pinless connector with an exemplary orientation indicator according to some embodiments;

[0055] Figure 9A This is a cross-sectional view of a catheter system according to some embodiments, illustrating an exemplary diaphragm actuator;

[0056] Figure 9B This is an enlarged cross-sectional view of a portion of a catheter system according to some embodiments, showing a diaphragm actuator and an exemplary cap that has been removed;

[0057] Figure 9C This is a cross-sectional view of a diaphragm actuator according to some embodiments;

[0058] Figure 9D This is a cross-sectional view of a pinless access connector coupled to a diaphragm actuator according to some embodiments;

[0059] Figure 9E This is a cross-sectional view of a connector connected to a diaphragm actuator according to some embodiments;

[0060] Figure 9F This is a cross-sectional view of a conduit system connected to a connector according to some embodiments;

[0061] Figure 9G This is a cross-sectional view of a catheter adapter according to some embodiments, showing an exemplary diaphragm;

[0062] Figure 9H This is a cross-sectional view of a catheter system according to some embodiments, showing another exemplary diaphragm;

[0063] Figure 10A This is a top perspective view of a prior art connector of a prior art blood-drawing device according to some embodiments;

[0064] Figure 10B This is a top perspective view of a catheter system according to some embodiments, showing a connector having multiple arms connected to a cap;

[0065] Figure 10C This is a schematic top view of a connector with multiple arms according to some embodiments; and

[0066] Figure 10D This is a top perspective view of a catheter system according to some embodiments, showing a connector having multiple arms that are coupled to a catheter adapter. Detailed Implementation

[0067] Now for reference Figure 1A-1C The prior art blood-drawing device 10 is shown. The prior art blood-drawing device 10 may correspond to the PIVO available from Becton, Dickinson and Company, Franklin Lake, New Jersey. TMNeedleless blood collection device. The prior art blood collection device 10 advances a flexible flow tube 11 through an indwelling peripheral venous catheter and into a blood vessel to collect a blood sample. The prior art blood collection device 10 includes a housing 12, which includes a proximal end 14, a distal end 16, and a slot 18 disposed between the proximal end 14 and the distal end 16 of the housing 12.

[0068] The prior art blood collection device 10 includes a connector 20 coupled to the distal end 16 of a housing 12. The prior art blood collection device 10 includes a slider 22 configured to move along a slot 18. The prior art blood collection 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 advance through an indwelling peripheral venous catheter in response to movement of the slider 22 along the slot 18 from a proximal position to a distal position. Blood can be collected through the flexible flow tube 11 as it advances through the indwelling peripheral venous catheter and is positioned within the blood vessel. In some cases, the flexible flow tube 11 can advance beyond a thrombus, valve, or other obstruction, extending to a new blood source. Therefore, the flexible flow tube 11 allows blood collection through an indwelling peripheral venous catheter, extending the use of the indwelling peripheral venous catheter without the need for further needle insertion. Blood can be collected via an adapter 24 at the proximal end of the flexible flow tube 11. Adapter 24 can be compatible with BD available from Becton, Dickinson and Company, Franklin Lake, New Jersey. LUER-LOK TM Access device.

[0069] Now for reference Figure 1D The prior art catheter system 26 is shown. The prior art catheter system 26 can correspond to the BD VENFLON available from Becton, Dickinson and Company, Franklin Lake, New Jersey. TMPro safety needle protects the IV cannula. Currently, the prior art catheter system 26 is not configured for use with the prior art blood collection device 10, and therefore blood collection from the prior art catheter system 26 may not be easy. The prior art catheter system 26 includes a catheter adapter 28 comprising a distal end 30, a proximal end 32, an inner lumen 34 extending through the distal end 30 and proximal end 32 of the catheter adapter 28, and a side port 36 disposed between the distal end 30 and proximal end 32 of the catheter adapter 28. The side port 36 is configured at 90° relative to the longitudinal axis of the catheter adapter 28. The prior art catheter system 26 may include a peripheral intravenous catheter 38 extending from the distal end 30 of the catheter adapter 28. The prior art catheter system 26 may include an annular valve 40 disposed within the inner lumen 34 and configured to seal the side port 36. A cap 41 is placed on the side port 36. The annular valve 40 is cylindrical and can collapse in various directions.

[0070] Because of the presence of the annular valve 40, it is difficult to connect the prior art blood-drawing device 10 to the side port 36 of the prior art catheter system 26 and to advance the flexible flow tube 11 through the side port 36 and the peripheral venous catheter 38. Furthermore, when the flexible flow tube 11 advances through the side port 36, it is difficult to change the direction of the flexible flow tube 11 inserted into the side port 36 to exit the peripheral venous catheter 38.

[0071] Now for reference Figures 2A-2E In some embodiments, the needleless access connector 42 may facilitate the advancement of the device 44 within the ported catheter system 46. In some embodiments, as the device 44 advances through the needleless access connector 42, the needleless access connector 42 may facilitate a change in orientation of the device 44, allowing the device 44 to be delivered distally through the catheter 48. In some embodiments, the catheter 48 may include a peripheral venous catheter, an arterial catheter, a midline catheter, a peripherally inserted central catheter, or another type of catheter.

[0072] In some embodiments, the catheter system 46 may include a catheter assembly, which may include a catheter adapter 50 and a catheter 48. In some embodiments, the catheter adapter 50 may include a distal end 52, a proximal end 54, an inner 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 may be configured at 90° relative to the longitudinal axis 60 of the catheter adapter 50. In some embodiments, the catheter 48 may extend from the distal end 52 of the catheter adapter 50.

[0073] In some embodiments, the catheter system 46 may be compatible with [other systems] in one or more features and / or operations. Figure 1DThe prior art catheter system 26 is similar to or identical to this one. In some embodiments, the catheter system 46 may 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 may include a device advancement feature. In some embodiments, when the device 44 is inserted through the side port 58, the device advancement feature may be configured to guide the device 44 in a distal direction within the lumen 56 of the catheter adapter 50. In some embodiments, the device advancement feature may gradually change the orientation of the device 44 so that the device 44 is not damaged.

[0074] 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.

[0075] 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.

[0076] like Figure 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.

[0077] 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.

[0078] 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.

[0079] like Figure 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.

[0080] 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, allowing the device 44 to be delivered distally through catheter 48.

[0081] 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.

[0082] 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... Figure 2A-2C Groove 68.

[0083] 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.

[0084] 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.

[0085] 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 Upon contact, 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.

[0086] 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 into the lumen 56.

[0087] 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.

[0088] 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.

[0089] 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.

[0090] 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.

[0091] 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.

[0092] It should be understood that these embodiments can be combined. For example, Figure 4F The annular valve 62 shown can be connected to Figure 4D The attachment sleeve 96. In some embodiments, the slit 94 may extend through the annular valve 62 and the second ramp 89. In some embodiments, the first ramp and / or the second ramp 89 may be integrally formed as a single unit with the annular valve 62.

[0093] Now for reference Figures 5A-5E In some embodiments, the side port 58 may be fixed at an angle of less than 90° relative to the distal end 52 and proximal end 54 of the catheter adapter 50 with respect to the longitudinal axis 60 of the catheter adapter 50. For example, the side port 58 may be fixed at an angle of 60°, 45°, 50°, 25°, or another suitable angle relative to the distal end 52 and proximal end 54 of the catheter adapter 50 with respect to the longitudinal axis 60 of the catheter adapter 50. More specifically, the central axis of the side port 58 may be fixed at an angle of 60°, 45°, 50°, 25°, or another suitable angle relative to the distal end 52 and proximal end 54 of the catheter adapter 50 with respect to the longitudinal axis 60 of the catheter adapter 50. In some embodiments, the catheter adapter 50 may be integrally formed as a single unit and / or constructed of a rigid material (e.g., rigid plastic).

[0094] In some embodiments, the catheter system 46 may include a cap 108 coupled to a side port 58. In some embodiments, the cap 108 may include a base 110 and an annular collar 112 extending from the base 110. In some embodiments, the central axis 114 of the cap 108 may be perpendicular to the longitudinal axis 60 of the catheter adapter 50. In some embodiments, the inner surface of the base 110 of the cap 108 may include a protrusion 116 that seals the side port 58. In some embodiments, because the outer surface of the cap 108 is straight or symmetrical about the central axis 114 perpendicular to the longitudinal axis 60, the cap 108 may facilitate gripping during insertion of the catheter 48 into the patient. In some embodiments, the interior of the cap 108 may be asymmetrical due to the protrusion 116.

[0095] In some embodiments, when the catheter system 46 is inserted into the patient's vascular system, the side port 58 may be located on top of the catheter adapter 50 or on the side furthest from the patient's skin. In some embodiments, the side port 58 located on top of the catheter adapter 50 may provide a means for inserting the instrument 44 (e.g., see...) Figure 2DAn easy access to a blood vessel is provided via catheter adapter 50. In some embodiments, catheter system 46 may include a needle hub 118 and a guide needle 120 extending distally from the needle hub 118. In some embodiments, guide needle 120 may include a sharp distal end configured to pierce the patient's skin and vascular system to insert catheter 48 through the skin into the vascular system. In some embodiments, guide needle 120 may include a bevel 122 forming the sharp distal end, which may face upward or toward the top of catheter system 46 in an insertion position ready for insertion into the patient, for example, as shown in the image. Figure 5A As shown.

[0096] For example, such as Figure 5D As shown, in some embodiments, the base 110 of the cap 108 may be sloped or inclined in the distal direction. More specifically, the inclined upper surface of the base 110 may provide a pushing feature on which a clinician can push distally when the catheter system 46 is inserted into the patient. For example, as Figures 5E-5F As shown, in some embodiments, the periphery of the cap 108 may be non-circular, such as elliptical, square, or rectangular, which can help the cap 108 cover the angled side port 58. In these embodiments, the periphery or shape of the cap 108 can facilitate gripping during insertion of the catheter 48 into the patient's body, while still allowing the cap 108 to cover the side port 58.

[0097] In some embodiments, side port 58 includes a movable connector (e.g., see...). Figures 7A-7B For example, hinges, ball sockets, or cylindrical sleeves can facilitate the movement of the side port 58 from a straight position perpendicular to the longitudinal axis 60 to an angled position relative to the longitudinal axis 60. In these and other embodiments, the outer surface of the catheter adapter 50 distal to the side port 58 may include a pusher that can be gripped to facilitate insertion of the catheter 48 into the patient.

[0098] Now for reference Figure 6 In some embodiments, the catheter adapter 50 may not include a direct access route that could provide the instrument 44 to the lumen 56 (e.g., see [link to relevant documentation]). Figure 2D The side port 58 of the conduit adapter 50. In these embodiments, the top of the conduit adapter 50 may include a flat and / or smooth surface, which may include a hole through it. In some embodiments, the hole may be aligned with and close to the annular valve 62.

[0099] Now for reference Figures 7A-7B In some embodiments, the side port 58 may include a movable connector 124 that can be in a straight position (e.g., as shown in the image). Figure 7A (as shown) and angular positions (e.g., as shown) Figure 7B The device 44 can move between the two positions shown. In some embodiments, for example, the movable connector 124 may be locked in a straight position and / or an angled position to prevent movement of the movable connector 124 during insertion of the catheter 48 into the patient. In some embodiments, the movable connector 124 may 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 movable connector 124 is in the angled position, the side port 58 may be pointed proximally and at an angle of less than 90° relative to the longitudinal axis 60 of the catheter adapter 50.

[0100] In some embodiments, the movable connector 124 may include a ball socket or a cylindrical sleeve. More specifically, in some embodiments, the movable connector 124 may include a ball portion that may include a generally spherical outer surface. In some embodiments, the ball portion may be configured to rotate within a socket that may include a generally spherical inner surface. In some embodiments, the ball portion and the socket may fit tightly together to prevent fluid leakage through the movable connector 124.

[0101] In some embodiments, a portion of the side port cavity 125 extending through the ball portion may be shaped such that the instrument 44 is not jammed or trapped when inserted through the side port 58. For example, when the movable connector 124 is in an angled position, such as Figure 7B As shown, the distal edge of this portion of the side port lumen 125 can be aligned with or close to the distal end of the hole through the catheter adapter 50 so as not to form a protrusion that would otherwise cause the instrument 44 to get stuck on.

[0102] In some embodiments, unlike the ball portion, the movable connector 124 may include a cylindrical portion. In some embodiments, the cylindrical portion may be configured to rotate within a sleeve, which may be generally cylindrical. For further details on exemplary ball sockets or cylindrical sleeves, see U.S. Patent No. 11,590,323, filed May 4, 2020, entitled “Catheter Assembly Support Device, System, and Method,” which is incorporated herein by reference in its entirety.

[0103] In some embodiments, the side port 58 may be made of a thinner and / or more flexible material than the rest of the catheter adapter 50, which would allow the side port 58 to buckle from a first angle to a second angle relative to the longitudinal axis 60 of the catheter adapter 50.

[0104] Now for reference Figures 8A-8BIn some embodiments, the side port 58 may include a side port cavity 125 having an asymmetrical shape. In some embodiments, all or a portion of the side port cavity 125 may include an asymmetrical shape. In these embodiments, the side port cavity 125 may facilitate the delivery of the connector 75 of the instrument delivery device 77 (e.g., see...). Figures 3A-3C Positioned in the desired orientation, the instrument advance feature guides the instrument 44 distally into the lumen of the catheter adapter 50. Therefore, the asymmetrical shape facilitates a "lock and key" engagement between the instrument delivery device 77 and the side port 58. In some embodiments, the asymmetrical shape may include an ellipse, triangle, rhombus, or another suitable shape.

[0105] Now for reference Figure 8C In some embodiments, the device delivery device 77 may include a direction indicator 126 to indicate to a clinician the orientation of the device delivery device 77 relative to the catheter assembly, such that a curved portion or other device advancement feature is configured to guide the device in a distal direction within the catheter assembly. In some embodiments, the direction indicator 126 may include an arrow or another suitable indicator. In some embodiments, the arrow or other suitable indicator may point to the catheter 48 or the catheter assembly. In some embodiments, a particular direction indicator 126 on the side port 58 or the catheter assembly may be configured to mate or align with another particular direction indicator 126 on the device delivery device 77 to indicate the correct orientation of the device delivery device 77 relative to the side port 58 or the catheter assembly. In some embodiments, a particular direction indicator 126 may include a first color, while another particular direction indicator 126 may include a second color, for example, the second color may be a different shade than the first color.

[0106] Now for reference Figure 8D In some embodiments, the catheter adapter 50 may include a direction indicator 126 to indicate to a 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 guide the instrument in a distal direction within the catheter assembly.

[0107] Now for reference Figure 8E In some embodiments, the needleless access connector 42 may include a direction indicator 126 to indicate to a 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 guide the instrument in a distal direction within the catheter assembly.

[0108] Now for reference Figures 9A-9CIn some embodiments, the split septum 128 and / or the septum actuator 130 may be disposed within the side port 58. In these and other embodiments, the annular valve 62 may be omitted. In some embodiments, a spring 134 may be coupled to the septum actuator 130 and configured to return the septum actuator 130 from a second position to a first position after the medical device has been removed from the side port 58. Thus, the septum actuator 130 can be used multiple times. In some embodiments, the septum actuator 130 may 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 may include an instrument delivery device 77 or another suitable medical device. In some embodiments, the split septum 128 may prevent backflow of blood or medication when the side port 58 is not in use.

[0109] Now for reference Figure 9D-9F In some embodiments, the diaphragm actuator 130 may be coupled to the pinless access connector 42 or connector 75. In some embodiments, the diaphragm actuator 130 may be coupled to the pinless access connector 42 or connector 75 by adhesive, interference fit, or other suitable methods. In these embodiments, the diaphragm actuator 130 may be inserted into the side port 58 in response to the pinless access connector 42 or connector 75 being coupled to the side port 58. In some embodiments, for example, as Figure 9F As shown, the diaphragm actuator 130 can be inserted through the diaphragm 128 to open the diaphragm 128 in response to the pinless access connector 42 or connector 75 being connected to the side port 58.

[0110] In some embodiments, the diaphragm actuator 130 may include an internal step, and the end of the long nose or insertion portion of the connector 75 may abut against the internal step. In some embodiments, the connection of the diaphragm actuator 130 to the needleless access connector 42 or the connector 75 may reduce the need for compression of the vein during insertion and blood draw, thereby reducing the risk of blood exposure.

[0111] Now for reference Figure 9G In some embodiments, a diaphragm 136 may be disposed at the end of the side port 58. In some embodiments, the diaphragm 136 may include a separating membrane having a slit extending therethrough. In some embodiments, the diaphragm 136 may cover the end of the side port 58 and / or be disposed within the side port cavity 125 in an interference-fit manner. In some embodiments, the side port 58 may include an annular protrusion configured to receive an opposing lever arm of a connector. Referring now to Figure 9H In some embodiments, the diaphragm 136 may be disposed within the cavity 125 of the side port and / or spaced apart from the end of the side port 58. In some embodiments, the diaphragm 136 may prevent the entry of microorganisms.

[0112] Figure 10A The connector 20 of a prior art blood-drawing device 10 is shown. Now refer to... Figure 10B-10D 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 10B ) or catheter adapter 50 (for example, see Figure 10D 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.

[0113] 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.

[0114] All examples and conditional language described herein are intended for pedagogical purposes to aid the reader's understanding of the present invention and the ideas 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 present 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 present invention.

Claims

1. A device delivery apparatus for inserting a device through a catheter assembly, characterized in that, The device delivery device includes: A housing, the housing including a proximal end, a distal end, and a slot disposed between the proximal end and the distal end of the housing; A connector, which is 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. The connector includes a bent portion configured to change the orientation of the instrument when it is pushed through the connector.

2. The instrument delivery device according to claim 1, characterized in that, The curved portion is configured to change the orientation of the instrument by 90° when the instrument is pushed through the connector.

3. The instrument delivery device according to claim 1, characterized in that, The curved portion includes grooves.

4. The instrument delivery device according to claim 1, characterized in that, The curved portion includes a closed passage.

5. The instrument delivery device according to claim 4, characterized in that, The closed passage is located within the straight end of the connector.

6. The instrument delivery device according to claim 5, characterized in that, The connector includes a male Luer connector configured to form a seal within the conduit assembly, wherein the straight end extends from the male Luer connector.

7. The instrument delivery device according to claim 4, characterized in that, The closed passage is located within the bent end of the connector.

8. The instrument delivery device according to claim 7, characterized in that, The connector includes a male Luer connector configured to form a seal within the conduit assembly, wherein the bent end extends from the male Luer connector.

9. The instrument delivery device according to claim 1, characterized in that, The device delivery device also includes a direction indicator that directs the clinician to the orientation of the device delivery device relative to the catheter assembly, such that the curved portion is configured to guide the device in a distal direction within the catheter assembly.

10. The instrument delivery device according to claim 1, characterized in that, The connector includes an insertion portion and a plurality of arms, wherein the insertion portion is configured to be inserted into the catheter assembly, and wherein the plurality of arms are configured to snap onto the exterior of the catheter assembly.

11. A catheter system, characterized in that, The catheter system includes: A catheter adapter, the catheter adapter including a distal end, a proximal end, an inner 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; A catheter extending from the distal end of the catheter adapter; An annular valve, the annular valve being disposed within the inner cavity and configured to seal the side port; and A device advancement feature, wherein when a device is inserted through the side port, the device advancement feature is configured to guide the device in a distal direction within the lumen of the catheter adapter.

12. The catheter system according to claim 11, characterized in that, The device propulsion feature includes a ramp disposed inside the annular valve.

13. The catheter system according to claim 11, characterized in that, The device advancement feature includes an attachment sleeve or adhesive that attaches the proximal end of the annular valve to the inner surface of the catheter adapter.

14. The catheter system according to claim 11, characterized in that, The instrument propulsion feature includes a ramp on the inner surface of the catheter adapter.

15. The catheter system according to claim 11, characterized in that, The catheter system also includes a needleless access connector, which comprises: The first end, the first end including a female Luer connector; and The second end is connected to the side port, wherein the second end includes the instrument propulsion feature, wherein the instrument propulsion feature includes a curved portion, wherein the curved portion includes a groove or a closed passage.

16. A catheter system, characterized in that, The catheter system includes: A catheter adapter includes a distal end, a proximal end, an inner 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 of less than 90° relative to the longitudinal axis of the catheter adapter. A catheter, the catheter extending from the distal end of the catheter adapter; and An annular valve, wherein the annular valve is disposed within the inner cavity and configured to seal the side port.

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

18. The catheter system according to claim 16, characterized in that, The side port includes a movable connector.

19. The catheter system according to claim 16, characterized in that, The side port includes a side port cavity with an asymmetrical shape.

20. The catheter system according to claim 16, characterized in that, The side port is fixed at an angle of less than 90° relative to the distal end and the proximal end of the catheter adapter with respect to the longitudinal axis of the catheter adapter, wherein the side port extends from the top of the catheter adapter, and the catheter system further includes a diaphragm disposed within the side port.

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