Catheter tip control devices and related systems and methods

Abstract

A catheter assembly can include a catheter adapter having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end. A wedge adapter can be held in the lumen and have a wedge coupled thereto. The wedge can be configured to hold an end of a catheter such that a tip of the catheter extends through the distal end of the catheter adapter. A control feature can extend through an end or sidewall of the catheter adapter. The control feature can be configured to manipulate the wedge to control a position of the catheter tip to open a fluid path within a vasculature.

Description

Technical Field

[0001] In general, this disclosure relates to the field of medical devices. Specifically, this disclosure relates to catheter devices, and more particularly to catheter tip control devices and related systems and methods. Background Technology

[0002] Catheters are commonly used for a variety of infusion therapies. For example, catheters can be used to infuse fluids into patients, such as saline solutions, various medications, and total parenteral nutrition. Catheters can also be used to draw blood from patients to obtain blood samples.

[0003] A common type of catheter is the cannula peripheral venous (“IV”) catheter. As the name suggests, a cannula catheter can be mounted on an insertion needle with a sharp distal end. The catheter and insertion needle can be assembled such that the distal end of the insertion needle extends beyond the distal end of the catheter, while the bevel of the needle faces upward away from the patient's skin. The catheter and insertion needle are typically inserted into the patient's vascular system through the skin at a shallow angle.

[0004] To verify proper placement of the insertion needle and / or catheter in the blood vessel, clinicians typically confirm the presence of blood "backflow" in the flash chamber of the catheter assembly. Once needle placement has been confirmed, clinicians can temporarily block flow in the vascular system and remove the needle, leaving the catheter in place for future blood draws, fluid infusions, or probe insertion.

[0005] However, catheter function can be impaired for several reasons, particularly when the catheter remains in the vascular system for an extended period. For example, when a catheter is inserted into a patient for more than a day, it may become prone to blockages and complications that impede fluid flow. For instance, the catheter may become blocked at its tip due to the presence of a fibrin sheath or thrombus that forms inside, on, or on the vein wall. As a result, while catheters are commonly used to collect blood samples during catheter placement, they are less frequently used to collect blood samples during catheter stay. When blood samples are needed during catheter stay, additional needle pricks are typically used to provide venous access for blood collection, which inflicts additional pain on the patient and increases material costs. However, it has been shown that moving or manipulating the catheter or the skin around it, also known as applying traction to move or reposition the catheter tip within the vein, can improve blood collection success rates and catheter function by avoiding blockages, obstructions, and / or thrombi, or by moving the tip to a location that improves blood flow.

[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 is provided merely to illustrate an example technical field in which some of the implementations described herein can be practiced. Summary of the Invention

[0007] This disclosure generally relates to catheter assemblies for infusing fluids into and / or collecting blood from a patient's vascular system. However, various complications and blockages can impede fluid flow through the catheter, thereby impairing its function and performance. For example, the catheter may become blocked at its distal end due to the presence of fibrin sheaths, thrombi, venous walls, or valves. Applying traction to the catheter to reposition the distal end within the patient's vascular system can significantly improve catheter function and blood collection success rates.

[0008] In some embodiments, the catheter assembly for opening a fluid path may include a catheter adapter having a proximal end, a distal end, and a lumen extending along a longitudinal axis between the proximal and distal ends. A wedge adapter may be retained within the lumen and has a wedge engaged therewith. In some embodiments, the wedge may be configured to retain an end of the catheter such that the distal end of the catheter extends through the distal end of the catheter adapter.

[0009] In some embodiments, the control feature may be located at the proximal end of the wedge adapter. The control feature may extend through the proximal end and / or sidewall of the catheter adapter. In some embodiments, the control feature may be configured to manipulate the wedge to control the position of the catheter tip to open a fluid path.

[0010] In some embodiments, the end of the conduit may be coupled to the wedge via an interference fit. In some embodiments, the wedge may be coupled to the wedge adapter via an interference fit or an adhesive.

[0011] In some embodiments, the control feature may include a tab, a handle, a button, and / or a dial. In some embodiments, the tab or handle may be configured to move proximally to retract the catheter tip relative to the distal end of the catheter adapter. In some embodiments, the tab or handle may be configured to retract the catheter tip relative to a fixed portion of the catheter adapter. In some embodiments, the control feature may be moved to radially reposition the catheter tip to a more desirable location within the vein. In some embodiments, the control feature may move the catheter tip to a previous location or another location within the vein.

[0012] In some embodiments, the tab or handle may be movable distally to advance the tip of the catheter relative to the fixed portion of the catheter adapter or relative to the distal end of the catheter adapter. In some embodiments, the tab or handle may be movable distally to move the tip of the catheter to another or a previous position within the vein.

[0013] In some embodiments, the control feature may include a button or tab and may be configured to be pressed against a wedge to control the position of the catheter tip. In some embodiments, the control feature may include a dial and is configured to be rotatable in the lateral direction relative to the longitudinal axis to control the position of the catheter tip.

[0014] In some embodiments, the catheter assembly may include a locking element to engage a control feature and / or a wedge adapter to secure the position of the catheter tip. In some embodiments, the catheter assembly may also include a diaphragm disposed in the lumen of the catheter adapter to seal the proximal end. In some embodiments, the control feature may be disposed proximal to the diaphragm.

[0015] In some embodiments, the catheter adapter may include a first segment and a second segment, the first segment including a distal end and the second segment including a proximal end. In some embodiments, the first segment may be slidable relative to the second segment along a longitudinal axis. In some embodiments, the catheter may extend from the distal end of the first segment such that the first segment can be moved distally relative to the second segment to open a fluid path.

[0016] In some embodiments, the catheter assembly may include an outer sleeve extending distal to the catheter adapter. The outer sleeve may be configured to receive the catheter therethrough, allowing the catheter to slide within the outer sleeve. In some embodiments, the catheter assembly may include an actuating element having a first portion coupled to the catheter and a second portion coupled to the outer sleeve. In some embodiments, depressing the actuating element may retract the catheter relative to the outer sleeve, and releasing the actuating element may advance the catheter relative to the outer sleeve.

[0017] In some embodiments, the conduit assembly for opening a fluid path may include a conduit adapter and a conduit extending distally from the conduit adapter. A stationary base element may be configured to receive the conduit adapter such that movement of the conduit adapter relative to the stationary base element controls the position of the conduit tip.

[0018] In some embodiments, the catheter adapter can be linearly translated along the longitudinal axis to control the position of the catheter tip. In some embodiments, the catheter adapter can be configured to rotate laterally relative to the longitudinal axis to control the position of the catheter tip.

[0019] In some embodiments, the catheter adapter may include a side port coupled to an extension kit, wherein the extension kit is configured to rotate laterally relative to a longitudinal axis to rotate the catheter adapter. In some embodiments, a post may extend through a helical track of a stationary base element and may contact the catheter adapter. In some embodiments, the helical track may extend along a surface of the stationary base element in a direction parallel to the longitudinal axis. The post may translate axially along the helical track in response to rotation of the catheter adapter.

[0020] In some embodiments, the catheter assembly may include a traction protrusion coupled to a surface of the catheter adapter and / or a stationary base element to facilitate applying traction to the catheter. In some embodiments, the traction protrusion may include a curved and / or textured distal surface. In some embodiments, the catheter assembly may include a spring or other means or feature for applying traction to the catheter. In some embodiments, the spring or other means or feature may be pre-tensioned by other movements.

[0021] It should be understood that the foregoing summary description and the following detailed description are exemplary and illustrative, and not intended to limit the invention as claimed in the claims. 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, or other embodiments may be utilized, and structural changes may be made without departing from the scope of the various embodiments of this disclosure unless claimed. Therefore, the following detailed description is not restrictive. Attached Figure Description

[0022] Example embodiments will be described and explained with additional features and details using the accompanying drawings, in which:

[0023] Figure 1 This is a cross-sectional view of an example conduit assembly, showing an example wedge-shaped adapter and an example control feature including a dial, according to some embodiments;

[0024] Figure 2A This is a cross-sectional view of another example conduit assembly, showing another example control feature including a tab actuator according to some embodiments;

[0025] Figure 2B yes Figure 2A A cross-sectional view of the conduit assembly, showing the retraction of the tab actuator according to some embodiments;

[0026] Figure 3 This is a cross-sectional view of an example control feature including a button actuator according to some embodiments;

[0027] Figure 4AThis is a cross-sectional view of another example control feature including a sliding actuator and a wedge adapter according to some embodiments;

[0028] Figure 4B This is a cross-sectional view of another example control feature including a locking element according to some embodiments;

[0029] Figure 5 This is a cross-sectional view of an example conduit adapter having a sliding section according to some embodiments;

[0030] Figure 6A This is a cross-sectional view of an example actuating element connected to an outer sleeve and a conduit according to some embodiments;

[0031] Figure 6B yes Figure 6A A cross-sectional view of the toggle element, showing the toggle element in an extended position according to some embodiments;

[0032] Figure 7 This is a top perspective view of another example toggle element according to some embodiments;

[0033] Figure 8 This is a top perspective view of another example catheter assembly, including an example static base element and an example catheter adapter, according to some embodiments, the catheter adapter having an extension kit;

[0034] Figure 9A This is a top perspective view of another example catheter assembly, including another example static base element and an example catheter adapter, according to some embodiments;

[0035] Figure 9B yes Figure 9A An enlarged perspective view of the catheter assembly shows the rotation of the catheter adapter relative to the stationary base element according to some embodiments; while

[0036] Figure 10 This is a perspective view of an example catheter assembly having an example traction protrusion according to some embodiments. Detailed Implementation

[0037] As used in this specification, the term "distal" refers to the direction away from the clinician who places the device in contact with the patient and closer to the patient. The term "proximal" refers to the direction closer to the clinician who places the device in contact with the patient and further away from the patient. Thus, for example, the end of the catheter that first touches the patient's body is the distal end, and the opposite end of the catheter is the proximal end.

[0038] Now for reference Figure 1In some embodiments, the catheter assembly 100 may be configured to control the position of the distal end 120 of the catheter 116 within the patient's vascular system to avoid obstruction and open a fluid pathway for blood collection or fluid delivery. In some embodiments, the catheter 116 may include a peripheral IV catheter 116, a peripherally inserted central catheter 116, or a midline catheter 116. In some embodiments, the catheter assembly 100 may have been pre-inserted into the patient's vascular system and may reside within the vascular system. In this case, the catheter 116 may be easily blocked by debris (e.g., fibrin or thrombus), and / or the distal end 120 of the catheter 116 may adhere to the vascular system. Therefore, blood aspiration using the catheter 116 may be difficult.

[0039] Example catheter assembly 100 may include catheter adapter 102 having a proximal end 104, a distal end 106, and a lumen 108 extending along a longitudinal axis 110 between the proximal end 104 and the distal end 105. In some embodiments, reference is made to the following. Figure 8 and Figure 9A , 9B Discussed in more detail, catheter adapter 102 may further include side ports and an integrated extension kit for infusion, blood draw, or device delivery. In some embodiments, wedge adapter 112 may be retained within lumen 108 and may have a wedge 114 engaged therewith. In some embodiments, wedge adapter 112 may include an opening 132 or a recess to receive and retain the wedge 114. In some embodiments, opening 132 may retain the wedge 114 such that the distal end of the wedge 114 is exposed, thereby facilitating the engagement of catheter 116 thereto. In these and other embodiments, opening 132 may be aligned with the distal end 106 of catheter adapter 102 such that the distal end 120 of catheter 116 may extend through the distal end 106 when catheter 116 is engaged to wedge 114. Some embodiments may engage wedge 114 to wedge adapter 112 by interference fit, adhesive, and / or any other suitable engagement mechanism.

[0040] In some embodiments, the distal end of the wedge 114 may be configured to retain the end 118 of the conduit 116. In some embodiments, for example, the inner diameter of the conduit 116 may be equal to or greater than the diameter of the wedge 114. In some embodiments, the diameter of the wedge 114 may gradually increase proximally along the wedge 114 to facilitate attachment of the conduit 116 to the wedge 114 via a press fit or interference fit. In some embodiments, the conduit 116 may be attached to the wedge via an adhesive or other coupling mechanism. In some embodiments, the end 118 of the conduit 116 may be retained by the distal end of the wedge 114 such that the distal end 120 of the conduit 116 extends through the distal end 106 of the conduit adapter 102. In other embodiments, the end 118 of the conduit 116 may be directly attached to the conduit adapter 102 by an adhesive or other suitable element.

[0041] In some embodiments, the catheter assembly 100 may include a control feature 122 for manipulating the position and / or orientation of the wedge 114. In some embodiments, controlling the wedge 114 in this manner may control the distal end 120 of the catheter 116. In some embodiments, the control feature 122 may be used to open a fluid pathway by positioning the distal end 120 of the catheter 116 to avoid or clear blockages, thereby providing access to the patient's vascular system without any additional needle insertion. For example, in some embodiments, the control feature 122 may control the position of the distal end 120 of the catheter 116 to ensure an unobstructed pathway for collecting blood samples. In some embodiments, the catheter assembly 100 may be used for needle-free blood collection and / or fluid infusion.

[0042] like Figure 1 As shown, in some embodiments, the control feature 122 may include a tab 124 coupled to or integral with the proximal end of the wedge adapter 112. In some embodiments, the tab 124 may extend beyond the proximal end 104 of the conduit adapter 102 and may be movable along the longitudinal axis 110.

[0043] Therefore, in operation, the user can grasp the tab 124 and pull it proximally along the longitudinal axis 110 to translate the wedge adapter 112 proximally along the longitudinal axis 110. In some embodiments, the tab 124 or other control features 122 can be pulled or extended proximally beyond the proximal end 104 of the catheter adapter 102. Thus, in some embodiments, translation of the wedge adapter 112 can cause the wedge 114 to translate proximally along the longitudinal axis 110 to retract the distal end 120 of the catheter 116 within the vascular system. Similarly, in some embodiments, the tab 124 or other control features 122 can be pushed or moved distally along the longitudinal axis 110 to translate the wedge adapter 112 and the wedge 114 distally to advance the distal end 120 of the catheter 116 within the vascular system.

[0044] In some embodiments, the control feature 122 may include a dial 126 extending from the proximal end of the wedge adapter 112. In some embodiments, the dial 126 may be coupled to or integral with the tab 124. In operation, in some embodiments, the dial 126 may rotate the wedge adapter 112 and the wedge 114 in a lateral direction relative to the longitudinal axis 110. In some embodiments, rotating the dial 126 in this manner may rotate the distal end 120 of the catheter 116 within the vascular system to manipulate the catheter 116 as needed. In some embodiments, the tab 124 and the dial 126 may be used in combination to move the distal end 120 of the catheter 116 forward, backward, laterally, and / or obliquely within the vascular system. In some embodiments, combined axial and rotational movements of the control feature 122 may manipulate the distal end 120 of the catheter 116 in any direction within the vascular system.

[0045] As shown in these and other embodiments, a diaphragm or fluid seal 128 may be disposed at or within the proximal end 104 of the conduit adapter 102 to close the fluid path. In some embodiments, a control feature 122 and / or a wedge adapter 112 may extend through the fluid seal 128 and allow the control feature 122 to move relative to the fluid seal 128. In some embodiments, the fluid seal 128 may comprise silicone, rubber, elastomer, plastic, rubber composite, or another suitable material. In some embodiments, the fluid seal 128 may be provided via an interference fit, a mechanical helical connection, or other connection or other suitable feature or mechanism. In some embodiments, the fluid seal 128 may include orifices, slits, etc., through which the control feature 122 and / or the wedge adapter 112 are received. In this way, some embodiments of the control feature 122 may manipulate the position of the end 120 of the conduit 116 while maintaining a closed fluid path.

[0046] In some embodiments, as discussed in more detail below, the catheter assembly 100 may include an outer sleeve 130 coupled to the distal end 106 of the catheter 116, such that the catheter 116 can be received within the outer sleeve 130 and can extend longitudinally through the outer sleeve 130. In some embodiments, the catheter 116 can move independently within the outer sleeve 130. In some embodiments, a lubricant or other suitable coating may be applied between the catheter 116 and the outer sleeve 130 to reduce friction between them. In other embodiments, the catheter assembly 100 may include a separate catheter 116 without the outer sleeve 130. In some embodiments, the catheter 116 and / or the outer sleeve 130 may include an antithrombotic material to reduce thrombus formation.

[0047] Now for reference Figure 2A and 2B Some embodiments of the control feature 122 may include a tab 124 coupled to the wedge adapter 112 such that the tab 124 extends through the sidewall 204 of the conduit adapter 102. In some embodiments, at least a portion of the wedge adapter 112 may surround or clamp at least a portion of the end 118 of the conduit 116 held by the wedge 114. In this way, some embodiments of the wedge adapter 112 may further secure the end 118 of the conduit 116 to the wedge 114. In operation, in some embodiments, a user may manipulate the position and / or orientation of the tab 124 to manipulate the position of the wedge 114 in the same manner.

[0048] For example, such as Figure 2A As shown, the tab 124 can protrude through a slot 206 extending longitudinally along the outer surface of the sidewall 204. In some embodiments, the tab 124 can move along the length of the slot 206 such that translation of the tab 124 in the distal direction can also translate the wedge adapter 112 and the wedge 114 in the distal direction within the lumen 108, thereby advancing the distal end 120 of the catheter 116 within the vascular system. Similarly, translation of the tab 124 along the slot 206 in the proximal direction can translate the wedge adapter 112 and the wedge 114 proximally, thereby retracting the distal end 120 of the catheter 116 within the vascular system. In some embodiments, the slot 206 can be arranged around the circumference of the sidewall 204 such that the tab 124 can rotate to produce rotational movement of the distal end 120 of the catheter 116 within the vascular system.

[0049] In some embodiments, the slot 206 may extend along the outer surface 210 of the sidewall 204 of the catheter adapter 102 in a direction transverse to the longitudinal axis 110. In some embodiments, the slot 206 may include an "L" shape, such that a portion of the slot 206a extends along the outer surface 210 in a direction parallel to the longitudinal axis 110, and a second portion of the slot 206b extends in a direction transverse to the longitudinal axis 110. In any case, in some embodiments, translation of the tab 124 along the slot 206 in a direction transverse to the longitudinal axis 110 may rotate the associated wedge adapter 112 and wedge 114 to rotate the tip 120 of the catheter 116 within the vascular system.

[0050] Some embodiments of the catheter assembly 100 may include an outer sleeve 208 extending from the distal end 106 of the catheter adapter 102. In some embodiments, such as Figure 2B As shown, the outer sleeve 208 can be coupled to the distal end 118 of the catheter adapter 102, allowing at least a portion of the catheter 116 to extend through it. In some embodiments, the outer sleeve 208 can be coupled to the catheter adapter 102 via an interference fit, bushing, adhesive, or other suitable technology or device. In some embodiments, the outer sleeve 208 can thus be held in place as the catheter 116 moves, reducing the risk of phlebitis, displacement, and / or microbial invasion.

[0051] Now for reference Figure 3 In some embodiments, the control feature 122 may include a button 300 extending from the wedge adapter 112 through the top surface 408 of the conduit adapter 102. In this way, the button 300 can be accessed via the outside of the conduit adapter 102 and can be actuated by pressing the button 300 in a downward direction perpendicular to the longitudinal axis 110. In some embodiments, the button 300 may extend laterally through the sidewall 204 or proximal end 104 of the conduit adapter 102. In these and other embodiments, the button 300 can be actuated by pressing its top surface against the outer surface of the sidewall 204 in a lateral direction, or by pressing its side surface (similar to a lever) in a downward direction perpendicular to the longitudinal axis 110.

[0052] In these and other embodiments, button 300 may be configured to be pressed against wedge 114 to control the position of distal end 120 of catheter 116. In some embodiments, button 300 may push wedge 114 and distal end 118 of catheter 116 in a downward direction, thereby causing distal end 120 of catheter 116 to move in an upward direction within the vascular system.

[0053] In some embodiments, the wedge adapter 112 may include a biasing element 304 or a spring disposed between the wedge adapter 112 and the conduit adapter 102, such that pressing the button 300 compresses the biasing element 304. Similarly, the release button 300 may release the compression of the biasing element 304, such that the biasing element 304 pushes the wedge adapter 112 in an upward direction to its initial starting position.

[0054] In some embodiments, the wedge adapter 112 may include a locking element 302 to selectively fix the position of the wedge adapter 112 relative to the conduit adapter 102. In some embodiments, such as Figure 3 As shown, locking element 302 may include a protrusion extending from the lower edge of wedge adapter 112. In some embodiments, the lumen 112 of catheter adapter 102 may include a corresponding locking feature 306, such as a groove or other suitable feature. The locking feature 306 of catheter adapter 102 may selectively engage locking element 302 of wedge adapter 112 via, for example, snap-fit ​​engagement, to prevent the tip 120 of catheter 116 from moving within the vascular system.

[0055] In operation, some embodiments of button 300 can be pressed down against biasing element 304 to push wedge adapter 112 downward. Additionally, in some embodiments, button 300 can be tilted downward or translated proximally, causing locking element 302 to engage the corresponding locking feature 306. In this way, locking element 302 can secure the position of the distal end 120 of catheter 116 within the vascular system. In some embodiments, locking element 302 can be released from locking feature 306 in a similar manner. Specifically, in some embodiments, button 300 can be pressed down against biasing element 304. In some embodiments, button 300 can be tilted distally or pushed to disengage locking element 302 from locking feature 306. Biasing element 304 can then push wedge adapter 112 upward to its initial position.

[0056] Figure 4A and Figure 4B An alternative embodiment of the catheter assembly 100 is shown, including a button 300 extending from the wedge adapter 112. (See diagram below.) Figure 4AAs shown, in some embodiments, the control feature 122 may include a button 300 extending from the wedge adapter 112 and through the top surface 408 of the conduit adapter 102, such that the button 300 is accessible via the outside of the conduit adapter 102. In some embodiments, the button 300 may extend through the sidewall 204 or proximal end 104 of the conduit adapter 102. In some embodiments, the button 300 may extend through a slot 410 in the conduit adapter 102, such that the button 300 can be translated along the slot 410 to translate the wedge adapter 112 within the lumen 108.

[0057] like Figure 4A As shown, the wedge adapter 112 may be disposed in the lumen 108 of the conduit adapter 102 and may include a recess 400 having dimensions and shape configured to receive and retain the wedge 114. In some embodiments, the recess 400 may retain the wedge 114 via an interference fit, adhesive, or any other suitable fastening means or mechanism.

[0058] In some embodiments, the recess 400 may be substantially aligned with the distal end 106 of the catheter adapter 102 such that the distal end of the wedge 114 can hold the end 118 of the catheter 116, and the distal end 120 of the catheter 116 can extend through the distal end 106 of the catheter adapter 102. As shown, in some embodiments, the wedge adapter 112 may extend substantially perpendicular to the longitudinal axis 110.

[0059] In some embodiments, the wedge adapter 112 may include a locking element 302 to secure the wedge adapter 112 and the wedge 114 within the lumen 108. For example, as Figure 4A As shown, the locking element 302 may include a proximal portion 404 extending vertically from the lower edge 406 of the wedge adapter 112. In some embodiments, when the button 300 is actuated, the button 300 may translate proximally along the channel 410, thereby translating the wedge adapter 112 proximally within the lumen 108. In some embodiments, the proximal portion 404 of the wedge adapter 112 may engage a recess 414 formed by the shoulder 412 of the lumen 108, thereby causing the wedge 114 to misalign with the distal end 106 of the catheter adapter 102 to secure the position of the distal end 120 of the catheter 116 within the vascular system.

[0060] In some embodiments, such as Figure 4BAs shown, the locking element 302 may include a leg 402 extending distally from the proximal portion 404 in a direction parallel to the longitudinal axis 110. In some embodiments, pressing the button 300 downward may also push the wedge adapter 112 downward, causing the wedge adapter 112 and wedge 114 to misalign with the distal end 106 of the conduit adapter 102. In some embodiments, pressing the button 300 in this manner may align the leg 402 with the channel 410 in the lumen 108.

[0061] In some embodiments, button 300 can then be translated distally along slot 206, thereby translating leg 402 of wedge adapter 112 distally to engage channel 410 within lumen 108. In some embodiments, this can secure the position of distal end 120 of catheter 116 within the vascular system.

[0062] Now for reference Figure 5 In some embodiments, the catheter adapter 102 may include a first segment 500 and a second segment 502, the first segment 500 including a distal end 106 and the second segment 502 including a proximal end 104. In some embodiments, the catheter 116 may extend from the distal end 106 of the first segment 500. In some embodiments, the first segment 500 may slide axially relative to the second segment 502. In this way, in some embodiments, the first segment 500 may be moved proximally 508 relative to the second segment 502 to retract the distal end 120 of the catheter 116 within the vascular system, or may be moved distally 510 relative to the second segment 502 to advance the distal end 120 of the catheter 116 within the vascular system.

[0063] In some embodiments, a flexible joint 504 may be provided between the first segment 500 and the second segment 502. The flexible joint 504 may include a flexible polymer or other suitable material to provide flexibility and controlled relative movement between the first segment 500 and the second segment 502, thereby facilitating the application of traction force to the catheter 116. For example, in some embodiments, the flexible joint 504 may include a short section of rubber or other suitable material or device.

[0064] In some embodiments, the catheter assembly 100 may include one or more gripping elements 506a, 506b coupled to or integral with the first segment 500 and / or the second segment 502 to allow the first segment 500 and the second segment 502 to move relative to each other, thereby applying traction to the catheter 116. In some embodiments, the gripping elements 506a, 506b may include protrusions, recesses, tabs, handles, raised and / or textured surfaces, or other suitable features or elements to facilitate reliable gripping.

[0065] Now for reference Figure 6Aand Figure 6B In some embodiments, the stationary base element 608 can fix the position of the catheter adapter 102 relative to the patient. In some embodiments, the stationary base element 608 can be configured to allow the catheter adapter 102 to move relative to the stationary base element 608, such that the movement of the catheter adapter 102 can control the position of the tip 120 of the catheter 116 within the vascular system.

[0066] In some embodiments, the outer sleeve 208 may extend from the distal end 106 of the catheter adapter 102, or in some embodiments, from the distal end 610 of the stationary base element 608. Some embodiments of the outer sleeve 208 include at least a portion that can remain stationary within the vascular system. In some embodiments, the end 612 of the outer sleeve 208 may be coupled to the catheter adapter 102 or the stationary base element 608 via adhesive, bushing, interference fit, or by any other suitable method or means.

[0067] In some embodiments, the outer sleeve 208 may include an inner diameter sufficient to accommodate the outer diameter of the catheter 116, such that the outer sleeve 208 can pass through and receive the catheter 116. In some embodiments, the length of the outer sleeve 208 may be approximately the length of the catheter 116. In some embodiments, the length of the outer sleeve 208 may be less than the length of the catheter 116, such that the distal end 120 of the catheter 116 can extend distally beyond the outer sleeve 208.

[0068] In some embodiments, the catheter 116 may slide axially within the outer sleeve 208. In some embodiments, the catheter assembly 100 may include an actuating element 602 to translate the catheter 116 relative to the outer sleeve 208, thereby applying traction to the catheter 116 within the vascular system. The actuating element 602 may also reduce the risk of contamination when manipulating the catheter 116 within the vascular system. Figure 6A As shown, the conduit adapter 102 can be disposed on top of the stationary base element 608, and the outer sleeve 208 can be coupled to the distal end 610 of the stationary base element 608 such that the outer sleeve 208 is aligned with the conduit 116 of the conduit adapter 102. In this way, in some embodiments, the conduit 116 of the conduit adapter 102 can be received by the outer sleeve 208 of the stationary base element 608. In some embodiments, one or more sealing elements 614a, 614b can be disposed between the stationary base element 608 and the conduit adapter 102 to seal the fluid path between the conduit 116 and the outer sleeve 208.

[0069] In some embodiments, the actuating element 602 may include a resilient or flexible arm 600 having a first portion 604 coupled to the catheter adapter 102 and a second portion 606 coupled to the stationary base element 608. In some embodiments, the actuating element 602 may cause the catheter adapter 102 to be axially translated relative to the stationary base element 608 in a proximal and / or distal direction. In some embodiments, the actuating element 602 may cause the catheter adapter 102 to be laterally rotated relative to the stationary base element 608.

[0070] like Figure 6A and 6B As shown, in some embodiments, depressing the flexible arm 600 can push the first portion 604 and the associated catheter adapter 102 proximally relative to the stationary base element 608, thereby retracting the catheter 116 relative to the outer sleeve 600. Similarly, in some embodiments, releasing the downward pressure on the flexible arm 600 can move the first portion 604 of the flexible arm 600 and the associated catheter adapter 102 distally relative to the stationary base element 608, thereby advancing the catheter 116 relative to the outer sleeve 600. Alternatively, in some embodiments, the first portion 604 and / or the second portion 606 of the flexible arm 600 can be manually or automatically manipulated to move the catheter adapter 102, thereby retracting, advancing, or rotating the tip 120 of the catheter 116 within the vascular system. In any case, in some embodiments, the outer sleeve 208 can remain fixed within the vascular system so that the insertion site is unaffected by the movement of the catheter 116.

[0071] Now for reference Figure 7 In some embodiments, the actuating element 602 may include a switching element 700, which is coupled to the conduit 116 and extends through a hole 702 in the outer sleeve 208. In some embodiments, the lower end 704 of the switching element 700 may be coupled to the conduit 116 such that the upper end 706 of the switching element 700 can be tossed between a first position and a second position to translate the conduit 116 relative to the outer sleeve 208.

[0072] In some embodiments, the user can toggle the switch element 700 between a first position and a second position to verify the presence of blood backflow within the catheter adapter 102 in each position. In this way, the switch element 700 can be used to confirm that applying traction to the catheter 116 by retracting and / or advancing it within the vascular system will not impair the placement of the catheter 116 in the vein.

[0073] Now for reference Figure 8In some embodiments, the catheter adapter 102 may include a side port 800 coupled to the extension kit 802. In some embodiments, the stationary base element 608 may be stationary or fixed relative to the patient, for example by means of an adhesive applied to its bottom surface. In some embodiments, the stationary base element 608 may be configured to hold the catheter adapter 102 such that it can rotate relative to the stationary base element 608 and the longitudinal axis 110. In some embodiments, the catheter adapter 102 may be translated distally or proximally relative to the stationary base element 608 to apply traction to the catheter 116 within the vascular system.

[0074] In some embodiments, the conduit adapter 102 may include a fixed outer portion 814 that holds a rotatable inner portion 808. The rotatable inner portion 808 may include a wedge adapter 112, a wedge 114, and / or an end 118 of the conduit 116. In some embodiments, the inner portion 808 may include a pin, screw, post 804, or other suitable element coupled to an outer surface of the inner portion 808 and extending in a direction perpendicular to the longitudinal axis 110. In some embodiments, the post 804 or other suitable element may extend through a track or groove 806 of the fixed outer portion 814.

[0075] In some embodiments, the inner portion 808 may rotate within the outer portion 814, causing the post 804 to rotate within a recess 806 in the outer portion 814. In some embodiments, rotation of the catheter adapter 102 may cause the inner portion 808 to rotate or twist relative to the outer portion 814, thereby retracting the catheter 116 within the vascular system. In some embodiments, reversing the direction of rotation of the catheter adapter 102 may cause the inner portion 808 to move forward relative to the outer portion 814, thereby moving the catheter 116 forward within the vascular system.

[0076] In some embodiments, the groove 806 may extend longitudinally along the outer surface of the outer portion 814 of the catheter adapter 102. In operation, in some embodiments, rotation of the inner portion 808 of the catheter adapter 102 relative to the outer portion 814 of the catheter adapter 102 may cause the column 804 to translate axially along the groove 806 in a proximal direction.

[0077] Now for reference Figure 9A and 9BIn some embodiments, the stationary base element 608 may include one or more retaining straps 900, retaining channels, or other suitable retaining elements to rotatably retain the catheter adapter 102 relative to the stationary base element 608. In some embodiments, the retaining straps 900 may be centrally positioned relative to the stationary base element 608 and may extend on the catheter adapter 102 in a substantially transverse direction. In other words, the retaining straps 900 may extend vertically or obliquely on the catheter adapter 102 relative to the longitudinal axis 110 of the catheter adapter 102, thereby allowing the catheter adapter 102 to rotate relative to the stationary base element 608. In some embodiments, wings 810 of the stationary base element 608 may be disposed on opposite sides of the catheter adapter 102 to stabilize the catheter adapter 102 as it moves.

[0078] In some embodiments, one or more retaining straps 900 may be disposed adjacent to the side port 800 of the catheter adapter 102. In some embodiments, the side port 800 may be disposed between one or more retaining straps 900 to stabilize rotation of the side port 800 within the retaining straps 900. In some embodiments, rotation of the side port 800 relative to the stationary base element 608 may cause the catheter adapter 102 to rotate in the same manner. In some embodiments, an extension kit 802 may be coupled to the side port 800 to facilitate this rotation. For example, in some embodiments, a user may grasp the extension kit 802 to rotate the side port 800 and the associated catheter adapter 102.

[0079] In any case, rotating the catheter adapter 102 in one direction can cause the catheter adapter 102 to translate proximally relative to the stationary base element 608, thereby retracting the catheter 116 within the vascular system. Similarly, rotating the catheter 116 in the opposite direction can cause the catheter adapter 102 to translate distally relative to the stationary base element 608, thereby advancing the catheter 116 within the vascular system.

[0080] Now for reference Figure 10In some embodiments, the catheter assembly 100 may include a traction grip 1000 as a separate feature, or a feature that may be coupled to or integrated with the outer surface 1002 of the catheter adapter 102 and / or the stationary base element 700 to facilitate the application of traction force to the catheter 116. In some embodiments, the traction grip 1000 may be curved, or may include other suitable shapes to facilitate a reliable grip. In some embodiments, the traction grip 1000 may include one or more roughened or textured surfaces to increase friction, thereby aiding in a reliable grip. In some embodiments, the textured surface may include ridges, protrusions, depressions, or other suitable textural features. In some embodiments, the traction grip 1000 may include one or more markings 1006 to indicate finger placement, thereby contributing to consistency in traction application.

[0081] like Figure 10 As shown, in some embodiments, the traction handle 1000 may include a raised tab 1008 or protrusion integral with the outer surface 1002 of the catheter adapter 102 at its distal end 106. In some embodiments, the raised tab 1008 may include a distal surface 1004 that is curved in a proximal direction to facilitate the application of traction force to the catheter 116. In some embodiments, the distal surface 1004 may be roughened or otherwise textured and may be marked with one or more indicator marks 1006 to maintain consistency in the traction application location.

[0082] All examples and conditional language listed herein are for illustrative purposes, to aid the reader in understanding the concepts of this disclosure and the inventors' contributions to the advancement of the art, and are to be construed as not being limited to these specifically listed 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 conduit assembly for opening a fluid path, comprising: A catheter adapter configured to be secured to the outside of a patient, the catheter adapter including a proximal end, a distal end, and a lumen extending along a longitudinal axis between the proximal and distal ends; A wedge adapter, which is held within the lumen and has a wedge connected thereto, wherein the wedge is configured to hold the end of the catheter in the catheter adapter such that the end of the catheter extends through the distal end of the catheter adapter, and wherein the diameter of the wedge gradually increases along the wedge in the proximal direction; A control feature extending from the wedge adapter and through one of the sidewall and proximal end of the catheter adapter, wherein the control feature is configured to manipulate the wedge to control the position of the catheter tip to reposition the catheter tip within the patient's vascular system, thereby preventing obstruction and opening the fluid path; and A locking element for engaging at least one of the control feature and the wedge adapter, thereby fixing the position of the wedge adapter relative to the conduit adapter.

2. The catheter assembly according to claim 1, wherein, The end of the conduit is connected to the wedge via an interference fit.

3. The catheter assembly according to claim 1, wherein, The wedge is connected to the wedge adapter via one of the methods of interference fit and adhesive.

4. The catheter assembly according to claim 1, wherein, The control feature includes at least one of a tab, a handle, a button, and a dial.

5. The catheter assembly according to claim 4, wherein, At least one of the tab and the handle is configured to be movable in a proximal direction to retract the distal end of the catheter relative to the distal end of the catheter adapter, and is configured to be movable in a distal direction to advance the distal end of the catheter relative to the distal end of the catheter adapter.

6. The catheter assembly of claim 4, wherein, At least one of the button and the tab is configured to press against the wedge to control the position of the end of the conduit.

7. The catheter assembly according to claim 4, wherein, The dial is configured to rotate in the lateral direction relative to the longitudinal axis to control the position of the end of the catheter.

8. The catheter assembly according to claim 1, wherein, The locking element is configured to selectively engage with the locking feature to prevent the tip of the catheter from moving within the patient's vascular system.

9. The catheter assembly of claim 1, further comprising a septum disposed within the lumen of the catheter adapter to seal the proximal end, wherein, The control feature is located on the proximal side of the diaphragm.

10. The catheter assembly of claim 1, wherein, The catheter adapter includes a first segment and a second segment, the first segment including the distal end and the second segment including the proximal end, wherein the first segment is slidable relative to the second segment along the longitudinal axis.

11. The catheter assembly of claim 1, further comprising an outer sleeve extending from the distal end of the catheter adapter and configured to receive the catheter through the outer sleeve, wherein, The conduit is capable of sliding within the outer sleeve.

12. The catheter assembly of claim 11, further comprising an actuating element, the actuating element comprising a first portion coupled to the catheter and a second portion coupled to the outer sleeve.

13. The catheter assembly of claim 12, wherein, Pressing down the actuating element moves the conduit forward relative to the outer sleeve, and releasing the actuating element retracts the conduit relative to the outer sleeve.

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