Pediatric catheterization systems and related devices and methods

Abstract

This disclosure relates to a catheter system. The catheter system may include a catheter adapter, which may include a distal end, a proximal end, and an inner lumen extending through the distal and proximal ends of the catheter adapter. The catheter system may include an accordion-style tube, which may include a distal end coupled to the proximal end of the catheter adapter. The accordion-style tube may be positioned in a contracted position and is movable between a contracted position and an deployed position. The catheter system may include a Luer connector, which may be coupled to the proximal end of the accordion-style tube. The catheter system may include a needle assembly, which may include a needle hub and a guide needle extending distally from the needle hub. The accordion-style tube and the Luer connector may be disposed within the needle hub.

Description

Technical Field

[0001] This disclosure generally relates to vascular access systems and related devices and methods. In particular, this disclosure relates to a pediatric catheter system and related devices and methods. 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 peripheral intravenous (“IV”) catheter. In this case, the catheter may be mounted on a guide needle with a sharp distal tip. The catheter and guide needle may be assembled such that the distal tip of the guide needle extends beyond the distal tip of the catheter, and the bevel of the needle faces upward 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 small 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. Once needle placement has been confirmed, clinicians may temporarily block flow in the vascular system and remove the needle, leaving the catheter in place for future blood collection or infusion.

[0005] Confirmation of needle placement is challenging in pediatric patients, including infants, due to poor venous pressure. Furthermore, extravasation of catheter fluid can occur due to the smaller size of veins in pediatric patients, leading to medication leakage into surrounding tissues. In integrated catheter assemblies, an extension tube is integrated into and extends from a side port of the catheter adapter. The extension tube can be used for blood draws and / or infusions. Several additional challenges arise for pediatric patients when catheter assemblies are integrated. First, the use of multiple bandages to secure the extension tube to the pediatric patient's skin can cause discomfort and / or lead to removal or expulsion of the integrated catheter assembly. Second, integrated catheter assemblies typically require pre-filling with a larger flushing volume due to the increased dead zone within the assembly. Third, pediatric patients may find it difficult to support the weight and size of the integrated catheter assembly.

[0006] The subject matter claimed herein is not limited to embodiments that address any shortcomings or operate only in environments such as those described above. Rather, this background art is merely provided as an exemplary technical field for illustrating some of the implementations described herein. Summary of the Invention

[0007] This disclosure generally relates to vascular access systems and related apparatus and methods. In particular, this disclosure relates to a pediatric catheter system and related apparatus and methods. In some embodiments, the catheter system may include a catheter adapter, which may include a distal end, a proximal end, and an inner lumen extending through the distal and proximal ends of the catheter adapter. In some embodiments, the catheter adapter may include one or more pushers. In some embodiments, the catheter adapter may include a first wing and / or a second wing. In some embodiments, the first and second wings may extend outwardly from opposite sides of the body of the catheter adapter.

[0008] In some embodiments, the catheter system may include a concertinaed tube, which may include a distal end coupled to the proximal end of a catheter adapter and / or positioned in a constricted position. In some embodiments, the concertinaed tube may be movable between a constricted position and an extended position. In some embodiments, in response to the movement of the concertinaed tube between the extended and constricted positions, the length of the concertinaed tube may be reduced by 50% to 70%, including the end value. In some embodiments, the catheter system may have a length of about 75 mm or less.

[0009] In some embodiments, the catheter system may include a Luer connector that can be coupled to the proximal end of an accordion-style tube. In some embodiments, the Luer connector may include a cannula and a slit diaphragm surrounding the cannula. In some embodiments, the cannula may include one or more openings. In some embodiments, the proximal end of the slit diaphragm may form a seal with the inner surface of the Luer connector, which may reduce the dead zone within the Luer connector. In some embodiments, due to the reduced dead zone, the catheter system may be flushed with only about 2.0 ml. In some embodiments, the catheter system may be flushed with 2 to 2.5 ml (including the end value).

[0010] In some embodiments, the catheter system may include a needle assembly, which may include a needle hub and a guide needle extending distally from the needle hub. In some embodiments, an accordion-style tube and a Luer connector may be disposed within the needle hub. In some embodiments, the proximal end of the needle hub may include a flashback chamber in fluid communication with the lumen of the guide needle. In some embodiments, the needle hub may include a hydrophobic filter near the flashback chamber.

[0011] In some embodiments, the catheter system may include a catheter extending distally from a catheter adapter. In some embodiments, the distal end of the catheter may include one or more side holes. In some embodiments, the catheter may be configured to provide a flow rate of 1,235 ml / h to 5,400 ml / h (inclusive).

[0012] In some embodiments, the catheter system may include a passive safety mechanism, such as a passive needle safety clip. In some embodiments, the passive needle safety clip may be disposed within the needle hub, between the proximal end of the Luer connector and the needle hub. In some embodiments, the guide needle may extend through the passive needle safety clip. In some embodiments, the passive needle safety clip may include a proximal opening. In some embodiments, the outer surface of the guide needle may include a feature. In some embodiments, the outer diameter of the feature may be larger than the diameter of the proximal opening, such that the feature is prevented from moving proximally to the proximal side of the proximal opening.

[0013] In some embodiments, a method may include inserting a catheter system into a patient's vascular system. In some embodiments, the method may include removing a needle assembly from the catheter system inserted into the patient's vascular system. In some embodiments, after removing the needle assembly from the catheter system, the method may include moving an accordion-style tube from a constricted position to an extended position.

[0014] In some embodiments, after moving the accordion tube from a constricted position to an extended position, the method may include attaching an extension kit to the proximal end of the accordion tube. In some embodiments, the method may include administering medication to a patient via the extension kit.

[0015] In some embodiments, after moving the accordion-style tubing from the constricted position to the extended position, the method may include attaching an infusion device to the proximal end of the accordion-style tubing. In some embodiments, the pre-filling step may be omitted. In some embodiments, the catheter system may not be pre-filled before being inserted into the patient's vascular system. In some embodiments, the catheter system may be inserted into the patient's vascular system using only one hand. In some embodiments, the resistance on the guide needle may be less than about 1.1 N in response to removing the needle assembly from the catheter system inserted into the patient's vascular system.

[0016] It should be understood that, as claimed, the foregoing general description and the following detailed description are exemplary and illustrative, and not limiting. It should be understood that the various embodiments are not limited to the arrangements and means shown in the accompanying drawings. It should also be understood that these 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 this disclosure, unless so claimed. Therefore, the following detailed description should not be considered limiting. Attached Figure Description

[0017] With the aid of the accompanying drawings, exemplary embodiments will be described and illustrated with additional features and details, wherein:

[0018] Figure 1A This is a top perspective view of an example catheter system according to some embodiments;

[0019] Figure 1B According to some embodiments Figure 1A An exploded view of the catheter system;

[0020] Figure 1C According to some embodiments Figure 1A A cross-sectional view of the catheter system;

[0021] Figure 2A According to some embodiments Figure 1A The upper perspective view of the catheter system shows an exemplary needle assembly removed from the catheter system;

[0022] Figure 2B According to some embodiments Figure 1A The upper perspective view of the catheter system shows the needle assembly removed and an exemplary accordion tube in the extended position;

[0023] Figure 3A This is a cross-sectional view of an exemplary Luer connector according to some embodiments;

[0024] Figure 3B According to some embodiments Figure 3A A cross-sectional view of a Luer connector, showing an exemplary medical device coupled to the proximal end of the Luer connector;

[0025] Figure 4A According to some embodiments Figure 1A The upper perspective view of the catheter system shows an exemplary syringe coupled to the proximal end of the Luer connector;

[0026] Figure 4B According to some embodiments Figure 1A The upper perspective view of the catheter system shows an exemplary extension kit coupled to the proximal end of the Luer connector;

[0027] Figure 4C According to some embodiments Figure 1A The upper perspective view of the catheter system shows another exemplary blood collection device coupled to the proximal end of the Luer connector;

[0028] Figure 4D According to some embodiments Figure 1A The upper perspective view of the catheter system shows another exemplary extension kit coupled to the proximal end of the Luer connector;

[0029] Figure 5A It is in the contracted position according to some embodiments. Figure 1A Top perspective view of the accordion-style tube of the conduit system;

[0030] Figure 5BIt is in the unfolded position according to some embodiments. Figure 1A Top perspective view of the accordion-style tube of the conduit system;

[0031] Figure 6A According to some embodiments Figure 1A A top perspective view of an exemplary passive needle safety clip for a catheter system;

[0032] Figure 6B According to some embodiments Figure 1A A top view of a part of the conduit system;

[0033] Figure 6C It is a link according to some embodiments to Figure 1A Luer connectors for conduit systems Figure 6A Lower perspective view of the passive needle safety clip; and

[0034] Figure 6D According to some embodiments Figure 6A A top view of a passive needle safety clip that shields the exemplary sharp distal end of the guide needle. Detailed Implementation

[0035] Now for reference Figure 1A-1C In some embodiments, the catheter system 10 may include a catheter adapter 12, which may include a distal end 14, a proximal end 16, and an inner lumen 18 extending through the distal end 14 and the proximal end 16 of the catheter adapter 12. In some embodiments, the catheter adapter 12 may include one or more pushers 20. In some embodiments, the catheter adapter 12 may include a first wing 22a and / or a second wing 22b. In some embodiments, the first wing 22a and the second wing 22b may extend outward from opposite sides of the body of the catheter adapter 12.

[0036] In some embodiments, such as Figure 1C As shown, the catheter system 10 may include an accordion-style tube 24, which may include a distal end 26 connected to the proximal end 16 of the catheter adapter 12 and / or positioned in a constricted position. In some embodiments, the accordion-style tube 24 may be movable between a constricted position and an extended position. In some embodiments, in response to the movement of the accordion-style tube 24 between the extended and constricted positions, the length from the distal end 26 to the proximal end 28 of the accordion-style tube 24 may be reduced by 50% to 70%, including the end value. In some embodiments, in response to the movement of the accordion-style tube 24 between the extended and constricted positions, the length from the distal end 26 to the proximal end 28 of the accordion-style tube 24 may be reduced by approximately 60%.

[0037] In some embodiments, the conduit system 10 may include a Luer connector 30 that can be coupled to the proximal end 28 of the accordion tube 24. In some embodiments, the Luer connector 30 may include a sleeve 32 and a slit diaphragm 34 surrounding the sleeve 32. In some embodiments, the sleeve 32 may include one or more openings 36.

[0038] In some embodiments, the catheter system 10 may include a needle assembly 38, which may include a needle hub 40 and a guide needle 42 extending distally from the needle hub 40. In some embodiments, an accordion-style tube 24 and a Luer connector 30 may be disposed within the needle hub 40. In some embodiments, the proximal end 44 of the needle hub 40 may include a flashback chamber 46 in fluid communication with the lumen of the guide needle 42, the flashback chamber extending through the pointed distal end 48 of the guide needle 42. In some embodiments, the needle hub 40 may include a hydrophobic filter 50 near the flashback chamber 46. In some embodiments, the hydrophobic filter 50 may be fused to the proximal end 44 of the needle hub 40 and may reduce or eliminate the need for pre-inflation of the catheter system 10 before insertion into a vascular system. In some embodiments, the hydrophobic filter 50 may have an airflow capacity between 5 cc / min and 50 cc / min (inclusive) when subjected to 1.0 ± 0.1 PSI.

[0039] In some embodiments, the needle hub 40 may include one or more side grips 51. In some embodiments, the side grips 51 may include a generally elliptical surface, which may be generally flat and / or disc-shaped. In some embodiments, the generally elliptical surface may include one or more protrusions that may be aligned with the longitudinal axis of the needle hub 40 or in other configurations. In some embodiments, the pusher 20 and / or one or more other features (e.g., the side grips 51) may facilitate a variety of insertion or removal techniques, such as using one hand to insert the catheter system 10 into a patient's vasculature and / or remove the needle assembly 38 from the catheter system 10.

[0040] In some embodiments, the catheter system 10 may include a catheter 52 extending from the distal end 14 of the catheter adapter 12. In some embodiments, the distal end 54 of the catheter 52 may include a distal opening 56 aligned with the longitudinal axis of the catheter 52. In some embodiments, the catheter 52 may include one or more side holes 57 that provide additional fluid pathways into and out of the catheter 52. In some embodiments, the catheter 52 having one or more side holes 57 may be configured to provide a flow rate of about 1.235 ml / h to about 5.400 ml / h (including endpoints). In some embodiments, the catheter system 10 may have a length of about 75 mm. In some embodiments, the length of the catheter system may extend from the most distal portion of the distal end 54 of the catheter 52 to the most proximal portion of the proximal end 44 of the needle hub 40.

[0041] In some embodiments, the catheter system 10 may include a passive safety mechanism, such as a passive needle safety clip 58. In some embodiments, the passive needle safety clip 58 may be disposed in the needle hub 40, between the Luer connector 30 and the proximal end 44 of the needle hub 40.

[0042] In some embodiments, the catheter system 10 can reduce the area it occupies on a pediatric patient's body. In some embodiments, the catheter system 10 can be compact and may not include an extension tube extending from the catheter adapter 12, which can reduce the number of bandages used to secure the catheter system 10 to the patient's skin and eliminate the need for clamps. In some embodiments, the catheter system 10 can be straight and / or closed.

[0043] Now for reference Figure 2A-2B In some embodiments, a method may include inserting a catheter system 10 into a patient's vascular system. In some embodiments, in response to the insertion of a guide needle 42 into the vascular system, blood may flow through the guide needle 42 and into a flashback chamber 46, where a clinician can observe the blood. In some embodiments, the method may include removing a needle assembly 38 from the catheter system 10 inserted into the patient's vascular system. In some embodiments, the needle assembly 38 may be disposed of after removal from the catheter system 10.

[0044] In some embodiments, the pre-filling step may be omitted. In some embodiments, the catheter system 10 may not be pre-filled before being inserted into the patient's vascular system. In some embodiments, the drag force on the guide needle 42 may be less than about 1.1 N in response to removing the needle assembly 38 from the catheter system 10 inserted into the patient's vascular system.

[0045] In some embodiments, in response to removal of the needle assembly 38 from the catheter system, the sharp distal end 48 of the guide needle 42 can be shielded within a passive needle safety clip 58. In some embodiments, after removing the needle assembly 38 from the catheter system 19, the method may include moving the accordion-style tube 24 from a retracted position to an extended position, for example, as... Figure 2B As shown.

[0046] Now for reference Figures 3A-3B In some embodiments, after moving the accordion tube 24 from the retracted position to the extended position, the method may include coupling a medical device 62 to a Luer connector 30. The medical device 62 may include a blood collection device, an infusion device, or an extension kit. In some embodiments, when the accordion tube 24 is in the retracted position, the medical device 62 may be coupled to the Luer connector 30, and then the accordion tube 24 may be moved to the extended position.

[0047] In some embodiments, the proximal end 64 of the slit diaphragm 34 can form a seal with the inner surface 66 of the Luer connector 30, which can reduce the dead zone within the Luer connector 30. In some embodiments, the conduit system 10 can be flushed with only about 2.0 mL due to the reduced dead zone. In some embodiments, the conduit system 10 can be flushed with 2 to 2.5 mL (including the end value). In some embodiments, for example, the proximal end 64 of the slit diaphragm 34 can be easily disinfected with an alcohol swab.

[0048] In some embodiments, in response to insertion and / or coupling of the medical device 62 to the Luer connector 30, the medical device 62 may contact the slit diaphragm 34 and compress the medical device 62 distally to expose the cannula 32. In some embodiments, in response to opening of the slit diaphragm 34, fluid may flow distally from the medical device 62 through the opening 36 of the cannula 32 and out through the distal opening 68 of the Luer connector 30. In some embodiments, in response to opening of the slit diaphragm 34, blood may flow into the distal opening 68 of the Luer connector 30, flow proximally through the opening 36, and flow into the medical device 62, which may include a blood collection device.

[0049] In some embodiments, the distal end of the medical device 62 may include a Luer connector 70 compatible with the Luer connector 30. In some embodiments, the Luer connector 70 may include a male Luer connector, and the Luer connector 30 may include a female Luer connector. In some embodiments, the Luer connector 30 may include a 6% Luer taper connection (compliant with ISO 954) or other suitable percentage. In some embodiments, the Luer connector 70 may include a sliding male Luer connector or a threaded male Luer connector. In some embodiments, in response to the presence of the Luer connector 30 within the catheter system 10, clamping the extension tube may not be required during the coupling and / or disconnection of the medical device to and from the catheter system 10.

[0050] Now for reference Figure 4A In some embodiments, the medical device 62 may include an infusion device, such as a syringe, which may be coupled to the Luer connector 30. In some embodiments, the infusion device may be activated when the accordion-style tubing moves from a constricted position to an extended position. In some embodiments, fluid may flow through the catheter system 10 in response to activation of the infusion device or depressurization of the syringe plunger.

[0051] Now for reference Figure 4B In some embodiments, the medical device 62 may include an extension kit that can be used to administer medication to a patient or for other suitable purposes. In some embodiments, the method may include coupling the extension kit to the Luer connector 30. In some embodiments, after moving the accordion tube 24 from a retracted position to an extended position, the method may include administering medication to a patient via the extension or infusing fluid to a patient via the extension kit.

[0052] Now for reference Figure 4C In some embodiments, medical device 62 may include a blood collection device, such as a VACUTAINER. ® (Available from Beckton Dickinson, Franklin Lake, New Jersey) or other suitable blood collection devices. In some embodiments, the blood collection device may include a retainer 72 and a cannula 74 disposed within a punctureable elastomeric sheath 76. In some embodiments, the blood collection device may be configured to receive a vacuum blood collection tube. In some embodiments, the method may include collecting blood from a patient via the blood collection device after moving the accordion-style tube 24 from a constricted position to an extended position.

[0053] Now for reference Figure 4DIn some embodiments, the medical device 62 may include another extension kit, which may include a stop valve 82. In some embodiments, after moving the accordion-style cannula 24 from the retracted position to the extended position, the method may include administering medication to the patient through the other extension kit, or infusing fluid to the patient through the extension kit.

[0054] Now for reference Figures 5A-5B An accordion-style tube 24 is shown. In some embodiments, a clinician can position the accordion-style tube 24 in... Figure 5A The contraction position shown and Figure 5B The accordion tube 24 moves between the shown extended positions. In some embodiments, in response to the withdrawal of the guide pin 42, the accordion tube 24 can automatically move from the retracted position to the extended position. In some embodiments, the accordion tube 24 may include multiple pleats. In some embodiments, in response to the movement of the accordion tube 24 from the retracted position to the extended position, the length of the accordion tube 24 may increase. In some embodiments, the accordion tube 24 may be flexible and bendable. In some embodiments, the accordion tube 24 may be made of polyvinyl chloride, polytetrafluoroethylene, or other suitable materials.

[0055] Now for reference Figures 6A-6D According to some embodiments, a passive needle safety clip 58 is shown. In some embodiments, the passive needle safety clip 58 may include a V-shaped clip. In some embodiments, a guide needle 42 may extend through the passive needle safety clip 58. In some embodiments, the passive needle safety clip 58 may include a proximal opening 78. In some embodiments, the outer surface of the guide needle 42 may include a feature 80, which may include a ridge or other suitable feature. In some embodiments, the outer diameter of the feature 80 may be larger than the diameter of the proximal opening 78, such that the feature is prevented from moving proximal to the proximal side of the proximal opening 78. In some embodiments, the passive needle safety clip 58 may include a claw 83 that may engage with a Luer adapter in response to the guide needle 42 extending through the catheter adapter 12.

[0056] All examples and conditional language described herein are intended for pedagogical purposes to aid the reader's understanding of this disclosure and the inventors' ideas for further development of the art, and should be construed as not being limited to such specific examples and conditions. Although embodiments of this disclosure 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 this disclosure.

Claims

1. A catheter system, characterized by The catheter system comprises: a catheter adapter comprising a distal end, a proximal end, and a lumen extending through the distal end and the proximal end; an accordion tube comprising a distal end coupled to the proximal end of the catheter adapter and disposed in a collapsed position, wherein the accordion tube is movable between the collapsed position and an expanded position; a luer connector coupled to the proximal end of the accordion tube; and a needle assembly comprising a needle hub and a guide needle extending distally from the needle hub, wherein the accordion tube and the luer connector are disposed within the needle hub, wherein the luer connector is configured to extend through the accordion tube in response to movement of the accordion tube from the expanded position to the collapsed position such that the luer connector extends distally of the distal end of the accordion tube.

2. The catheter system of claim 1, wherein, The catheter system further comprises a catheter extending from the distal end of the catheter adapter, wherein a distal end of the catheter comprises a plurality of side holes.

3. The catheter system of claim 2, wherein, The catheter is configured to provide a flow rate of 1.235 milliliters per hour to 5.400 milliliters per hour, inclusive.

4. The catheter system of claim 1, wherein, The catheter system further comprises a passive needle safety clip disposed within the needle hub and between the luer connector and the proximal end of the needle hub, wherein the guide needle extends through the passive needle safety clip.

5. The catheter system of claim 4, wherein, The passive needle safety clip comprises a proximal opening, wherein an outer surface of the guide needle comprises a feature, wherein an outer diameter of the feature is greater than a diameter of the proximal opening such that the feature is prevented from moving proximally of the proximal opening.

6. The catheter system of claim 1, wherein, The accordion tube decreases in length by 50% to 70%, inclusive, when the accordion tube is moved between the expanded position and the collapsed position.

7. The catheter system of claim 1, wherein, The luer connector comprises a sleeve and a slit septum surrounding the sleeve, wherein the sleeve comprises a plurality of openings.

8. The catheter system of claim 7, wherein, A proximal end of the slit septum forms a seal with an inner surface of the luer connector.

9. The catheter system of claim 1, wherein, A proximal end of the needle hub comprises a flashback chamber and a hydrophobic filter proximate the flashback chamber.

10. The catheter system of claim 1, wherein, The catheter system has a length less than or equal to 75 millimeters.

11. The catheter system of claim 1, wherein, The catheter adapter comprises one or more push tabs.

12. The catheter system of claim 1, wherein, The catheter adapter comprises a first wing and a second wing, wherein the first wing and the second wing extend outwardly from opposite sides of a main body of the catheter adapter.

13. The catheter system of claim 1, wherein, A proximal end of the needle hub comprises a hydrophobic filter.

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