Catheter tip control device and related systems

Abstract

To provide a catheter assembly to open a fluid path for avoiding obstructions and opening a fluid path for blood collection or fluid delivery.SOLUTION: A catheter assembly to open a fluid path comprises: a catheter adapter comprising a proximal end, a distal end, and a lumen extending along a longitudinal axis therebetween; a catheter extending from the distal end of the catheter adapter; and a stationary base element configured to receive the catheter adapter such that movement of the catheter adapter relative to the stationary base element controls a position of a tip of the catheter.SELECTED DRAWING: Figure 6A

Description

[Background technology]

[0001] Catheters are commonly used for various infusion therapies. For example, catheters may be used to infuse fluids, such as saline, various medications, and total parenteral nutrition, into a patient. Catheters may also be used to withdraw blood from a patient to obtain a blood sample.

[0002] A common catheter is an over-needle peripheral intravenous ("IV") catheter. As the name suggests, an over-needle catheter is a catheter that can be fitted over an introducer needle that has a sharpened distal end. The catheter and introducer needle can be assembled so that the distal tip of the introducer needle extends beyond the distal tip of the catheter, with the needle bevel pointing away from the patient's skin. The catheter and introducer needle are typically inserted into the patient's vascular system at a shallow angle from the skin.

[0003] To verify proper placement of the introducer needle and / or catheter within the blood vessel, the clinician typically checks for a "flashback" of blood within the flashback chamber of the catheter assembly. Once needle placement is confirmed, the clinician may temporarily occlude flow within the vasculature and remove the needle, leaving the catheter in place for subsequent blood draws, infusions, or probe access.

[0004] However, catheter function can be hindered for several reasons, especially if the catheter remains in the vascular system for a long time. For example, leaving a catheter inserted in a patient for more than a day can make the catheter prone to complications and blockages that impede fluid flow. For example, a catheter may become blocked at its tip due to the presence of a fibrin sheath or thrombus that forms within or on the catheter or on the vein wall. As a result, while catheters are commonly used to obtain blood samples at the time of catheter placement, they are rarely used to obtain blood samples during the catheter's dwell period. If a blood sample is desired during the catheter placement period, an additional needle stick is typically used to provide venous access for blood collection, causing additional pain to the patient and increasing material costs. However, moving or manipulating the catheter or the skin around the catheter, also known as applying traction, to move or reposition the catheter tip within the vein has been shown to improve blood collection success and catheter function by avoiding blockages, obstructions, and / or thrombus, or by moving the tip to a position that promotes improved blood flow.

[0005] The subject matter claimed herein is not limited to embodiments that solve any shortcomings or that operate only in such environments. Rather, this background is only provided to illustrate one example technology area where some embodiments described herein may be practiced. Summary of the Invention

[0006] The present disclosure generally relates to catheter assemblies used to infuse fluids and / or collect blood from a patient's vascular system. However, various complications and blockages can impede fluid flow through the catheter, thus impairing its function and performance. For example, a catheter may become blocked at its tip due to the presence of a fibrin sheath, a thrombus, a vein wall, or a valve. Applying traction to the catheter can reposition the catheter's tip within the patient's blood vessel, significantly improving catheter functionality and the success rate of blood collection.

[0007] In some embodiments, a catheter assembly that opens a fluid pathway can include a catheter adapter having a proximal end, a distal end, and a lumen extending along a longitudinal axis therebetween. The wedge adapter can be retained within the lumen and have a wedge coupled thereto. In some embodiments, the wedge can be configured to retain an end of a catheter such that the tip of the catheter extends through the distal end of the catheter adapter.

[0008] In some embodiments, a 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 tip of the catheter to open the fluid pathway.

[0009] In some embodiments, the end of the catheter 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 adhesive.

[0010] 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 tip of the catheter relative to the distal end of the catheter adapter. In some embodiments, the tab or handle may be configured to retract the tip of the catheter relative to a fixed portion of the catheter adapter. In some embodiments, the control feature may be moved to radially reposition the tip of the catheter to a more desirable location within the vein. In some embodiments, the control feature may move the tip of the catheter to a previous location or to another location within the vein.

[0011] In some embodiments, the tab or handle can be moved 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, hi some embodiments, the tab or handle can be moved distally to move the tip of the catheter to a previous or another position within the vein.

[0012] 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, hi some embodiments, the control feature may include a dial and may be configured to rotate transversely to the longitudinal axis to control the position of the catheter tip.

[0013] In some embodiments, the catheter assembly may include a locking element for engaging the control feature and / or the wedge adapter to secure the position of the catheter tip. In some embodiments, the catheter assembly may further include a septum disposed within the lumen of the catheter adapter to seal the proximal end. In some embodiments, the control feature may be disposed proximal to the septum.

[0014] In some embodiments, the catheter adapter may include a first section including a distal end and a second section including a proximal end. In some embodiments, the first section may be slidable relative to the second section along a longitudinal axis. In some embodiments, the catheter may extend from the distal end of the first section such that the first section can move distally relative to the second section to open the fluid pathway.

[0015] In some embodiments, the catheter assembly may include an outer sleeve extending from the distal end of the catheter adapter. The outer sleeve may be configured to receive the catheter therethrough such that the catheter is slidable within the outer sleeve. In some embodiments, the catheter assembly may include a toggle element having a first portion coupled to the catheter and a second portion coupled to the outer sleeve. In some embodiments, depressing the toggle element may retract the catheter relative to the outer sleeve, and releasing the toggle element may advance the catheter relative to the outer sleeve.

[0016] In some embodiments, a catheter assembly for opening a fluid pathway may include a catheter adapter and a catheter extending from a distal end of the catheter adapter. A stationary base element may be configured to receive the catheter adapter such that movement of the catheter adapter relative to the stationary base element controls the position of the tip of the catheter.

[0017] In some embodiments, the catheter adapter may be linearly translated along the longitudinal axis to control the position of the catheter tip, hi some embodiments, the catheter adapter may be configured to rotate transversely relative to the longitudinal axis to control the position of the catheter tip.

[0018] In some embodiments, the catheter adapter may include a side port coupled to an extension set, the extension set configured to rotate transversely relative to the longitudinal axis to rotate the catheter adapter. In some embodiments, the post may extend through a screw track in the stationary base element and contact the catheter adapter. In some embodiments, the screw track may extend along a surface of the stationary base element in a direction parallel to the longitudinal axis. The post may be translated axially along the screw track in response to rotation of the catheter adapter.

[0019] In some embodiments, the catheter assembly may include a traction lug coupled to a surface of the catheter adapter and / or stationary base element to facilitate application of traction to the catheter. In some embodiments, the traction lug may include a curved and / or textured distal surface. In some embodiments, the catheter assembly may include a spring or other device or feature to facilitate application of traction to the catheter. In some embodiments, the spring or other device or feature may be pre-tensioned by other motions.

[0020] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are not restrictive of the present disclosure as claimed. It is to be understood that the various embodiments are not limited to the arrangements and instrumentality shown in the drawings. Also, it is to be understood that embodiments may be combined or other embodiments may be utilized, and that structural changes may be made without departing from the scope of the various embodiments of the present invention, unless so claimed. Therefore, the following detailed description is not to be taken in a limiting sense. [Brief explanation of the drawings]

[0021] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Figure 1] FIG. 1 is a cross-sectional view of an exemplary catheter assembly showing exemplary control features including an exemplary wedge adapter and a dial, according to some embodiments. [Figure 2A] FIG. 2A is a cross-sectional view of another exemplary catheter assembly illustrating another exemplary control feature including a tab actuator according to some embodiments. [Figure 2B] FIG. 2B is a cross-sectional view of the catheter assembly of FIG. 1A showing retraction of the tab actuator according to some embodiments. [Figure 3] FIG. 3 is a cross-sectional view of an exemplary control feature including a push button actuator, according to some embodiments. [Figure 4A] FIG. 4A is a cross-sectional view of another exemplary control feature including a slide actuator and a wedge adapter, according to some embodiments. [Figure 4B] FIG. 4B is a cross-sectional view of another exemplary control feature including a locking element, according to some embodiments. [Figure 5] FIG. 5 is a cross-sectional view of an exemplary catheter adapter having a slidable section, according to some embodiments. [Figure 6A] FIG. 6A is a cross-sectional view of an exemplary toggle element coupled to an outer sleeve and a catheter, according to some embodiments. [Figure 6B] FIG. 6B is a cross-sectional view of the toggle element of FIG. 6A showing the toggle element in an extended position, according to some embodiments. [Figure 7] FIG. 7 is a top perspective view of another exemplary toggle element according to some embodiments. [Figure 8] FIG. 8 is a top perspective view of another exemplary catheter assembly including an exemplary catheter adapter with an exemplary stationary base element and an extension set, according to some embodiments. [Figure 9A]FIG. 9A is a top perspective view of another exemplary catheter assembly including another exemplary stationary base element and an exemplary catheter adapter, according to some embodiments. [Figure 9B] FIG. 9B is an enlarged perspective view of the catheter assembly of FIG. 9A showing the rotation of the catheter adapter relative to the stationary base element, according to some embodiments. [Figure 10] FIG. 10 is a perspective view of an exemplary catheter assembly having an exemplary traction lug, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0022] As used herein, the term "distal" refers to a direction away from the clinician who contacts and brings the device into contact with the patient. The term "proximal" refers to a direction closer to the clinician who contacts the device with the patient and further from the patient. Thus, for example, the end of a catheter that first touches the patient's body is the distal end, while the opposite end of the catheter is the proximal end of the catheter.

[0023] 1 , in some embodiments, the catheter assembly 100 can be configured to control the position of the tip 120 of the catheter 116 within a patient's vasculature to avoid blockages and open a fluid pathway for blood withdrawal or fluid delivery. In some embodiments, the catheter 116 can include a peripheral IV catheter 116, a peripherally inserted central catheter 116, or a midline catheter 116. In some embodiments, the catheter assembly 100 can be pre-inserted into the patient's vasculature or can remain within the vasculature. In such cases, the catheter 116 can be susceptible to blockage by debris (e.g., fibrin or thrombus) and / or adhesion of the tip 120 of the catheter 116 to the vasculature. Therefore, drawing blood using the catheter 116 can be difficult.

[0024] The exemplary catheter assembly 100 may include a catheter adapter 102 having a proximal end 104, a distal end 106, and a lumen 108 extending along a longitudinal axis 110 therebetween. In some embodiments, as discussed in more detail below with reference to FIGS. 8 and 9A-B, the catheter adapter 102 may further include a side port and integral extension set for infusion, blood withdrawal, or instrument delivery. In some embodiments, a wedge adapter 112 may be retained within the lumen 108 and may have a wedge 114 coupled thereto. In some embodiments, the wedge adapter 112 may include an opening 132 or recess for receiving and retaining the wedge 114. In some embodiments, the opening 132 may retain the wedge 114 such that the distal end of the wedge 114 is exposed, thereby facilitating coupling of a catheter 116 thereto. In these and other embodiments, the opening 132 may align with the distal end 106 of the catheter adapter 102 such that when the catheter 116 is coupled to the wedge 114, the tip 120 of the catheter 116 can extend through the distal end 106. Some embodiments may couple the wedge 114 to the wedge adapter 112 via an interference fit, adhesive, and / or any other suitable coupling mechanism.

[0025] In some embodiments, the distal end of the wedge 114 may be configured to retain the end 118 of the catheter 116. In some embodiments, for example, the catheter 116 may include an inner diameter 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 coupling the catheter 116 to the wedge 114 via a press fit or interference fit. In some embodiments, the catheter 116 may be coupled to the wedge via an adhesive or other coupling mechanism. In some embodiments, the end 118 of the catheter 116 may be retained by the distal end of the wedge 114 such that the tip 120 of the catheter 116 extends through the distal end 106 of the catheter adapter 102. In other embodiments, the end 118 of the catheter 116 may be directly coupled to the catheter adapter 102 via an adhesive or other suitable element.

[0026] In some embodiments, the catheter assembly 100 may include control features 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 tip 120 of the catheter 116. In some embodiments, the control features 122 may be used to open a fluid pathway by positioning the tip 120 of the catheter 116 to avoid or clear an obstruction, thus providing access to the patient's vasculature without an additional needlestick. For example, in some embodiments, the control features 122 may control the position of the tip 120 of the catheter 116 to clear a pathway for collecting a blood sample. In some embodiments, the catheter assembly 100 may be used for needleless blood collection and / or fluid injection.

[0027] 1 , 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 catheter adapter 102 and may be movable along the longitudinal axis 110.

[0028] Thus, in operation, a user can grasp and pull tab 124 proximally along longitudinal axis 110 to translate wedge adapter 112 proximally along longitudinal axis 110. In some embodiments, tab 124 or other control feature 122 can be pulled or extended proximally beyond the proximal end 104 of catheter adapter 102. In some embodiments, translation of wedge adapter 112 can thus translate wedge 114 proximally along longitudinal axis 110 to retract tip 120 of catheter 116 within the vasculature. Similarly, in some embodiments, tab 124 or other control feature 122 may be pushed or moved distally along longitudinal axis 110, thereby translating wedge adapter 112 and wedge 114 distally to advance tip 120 of catheter 116 within the vasculature.

[0029] 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 transversely relative to the longitudinal axis 110. In some embodiments, rotation of the dial 126 in this manner may rotate the tip 120 of the catheter 116 within the vasculature to steer the catheter 116 as needed. In some embodiments, the tab 124 and the dial 126 may be used in combination to move the tip 120 of the catheter 116 forward, backward, laterally, and / or diagonally within the vasculature. In some embodiments, the combined axial and rotational movement of the control feature 122 may steer the tip 120 of the catheter 116 in any direction within the vasculature.

[0030] As shown in these and other embodiments, a septum or fluid seal 128 may be disposed at or within the proximal end 104 of the catheter adapter 102 to close the fluid pathway. In some embodiments, the control feature 122 and / or the wedge adapter 112 may extend through the fluid seal 128, allowing movement of the control feature 122 relative thereto. In some embodiments, the fluid seal 128 may comprise silicone, rubber, elastomer, a plastic and rubber composite, or another suitable material. In some embodiments, the fluid seal 128 may be provided via an interference fit, mechanical threading, or other connection, or other suitable feature or mechanism. In some embodiments, the fluid seal 128 may include an opening, slit, etc. to accommodate the control feature 122 and / or the wedge adapter 112 therethrough. In this manner, some embodiments of the control feature 122 may manipulate the position of the tip 120 of the catheter 116 while maintaining a closed fluid pathway.

[0031] 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 and extend longitudinally therethrough. In some embodiments, the catheter 116 may be independently movable 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 the two. In other embodiments, the catheter assembly 100 may include a standalone catheter 116 without an outer sleeve 130. In some embodiments, the catheter 116 and / or the outer sleeve 130 may include an anti-thrombogenic material to reduce thrombus formation.

[0032] 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 catheter adapter 102. In some embodiments, at least a portion of the wedge adapter 112 can surround or grip at least a portion of the end 118 of the catheter 116 held by the wedge 114. In this manner, some embodiments of the wedge adapter 112 can further secure the end 118 of the catheter 116 onto 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.

[0033] 2A , for example, tab 124 may protrude through a slot 206 extending longitudinally along the outer surface of sidewall 204. In some embodiments, tab 124 may be movable along the length of slot 206 such that translating tab 124 distally can translate wedge adapter 112 and wedge 114 distally within lumen 108, thereby advancing tip 120 of catheter 116 within the vasculature. Similarly, translating tab 124 proximally along slot 206 can translate wedge adapter 112 and wedge 114 proximally, retracting tip 120 of catheter 116 within the vasculature. In some embodiments, slot 206 may be disposed about the circumference of sidewall 204 such that tab 124 can be rotated to cause rotational movement of tip 120 of catheter 116 within the vasculature.

[0034] In some embodiments, the slot 206 may extend along the outer surface 210 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 one 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 either 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, thereby rotating the catheter 116 tip 120 within the vasculature.

[0035] 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, as shown in FIG. 2B , the outer sleeve 208 may be coupled to the distal end 118 of the catheter adapter 102 such that at least a portion of the catheter 116 can extend therethrough. In some embodiments, the outer sleeve 208 may be coupled to the catheter adapter 102 via an interference fit, a bushing, an adhesive, or other suitable technique or device. In some embodiments, the outer sleeve 208 may thus remain in place when the catheter 116 is moved, reducing the risk of phlebitis, dislodgement, and / or microbial introduction.

[0036] 3 , in some embodiments, the control feature 122 may include a push button 300 that extends from the wedge adapter 112 through the top surface 408 of the catheter adapter 102. In this manner, the push button 300 may be accessible via the exterior of the catheter adapter 102 and may be actuated by depressing the button 300 in a downward direction perpendicular to the longitudinal axis 110. In some embodiments, the push button 300 may extend laterally through the side wall 204 or proximal end 104 of the catheter adapter 102. In these and other embodiments, the push button 300 may be actuated by depressing the top surface of the push button 300 laterally against the exterior surface of the side wall 204, or by depressing the side of the push button 300 in a downward direction perpendicular to the longitudinal axis 110, like a lever.

[0037] In these and other embodiments, the push button 300 may be configured to be pressed against the wedge 114 to control the position of the tip 120 of the catheter 116. In some embodiments, the push button 300 may compress the wedge 114 and end 118 of the catheter 116 downward, thereby moving the tip 120 of the catheter 116 upward within the vasculature.

[0038] In some embodiments, wedge adapter 112 may include a biasing element 304 or spring disposed between wedge adapter 112 and catheter adapter 102 such that depressing push button 300 compresses biasing element 304. Similarly, releasing push button 300 may release the compression of biasing element 304 such that biasing element 304 urges wedge adapter 112 upward to its initial start position.

[0039] In some embodiments, the wedge adapter 112 may include a locking element 302 for selectively securing the position of the wedge adapter 112 relative to the catheter adapter 102. In some embodiments, as shown in FIG. 3 , the locking element 302 may include a protrusion extending from a lower edge of the wedge adapter 112. In some embodiments, the lumen 112 of the catheter adapter 102 may include a corresponding locking feature 306, such as a groove or other suitable feature. The locking feature 306 of the catheter adapter 102 may selectively engage the locking element 302 of the wedge adapter 112 via a snap fit, for example, to prevent movement of the tip 120 of the catheter 116 within the vasculature.

[0040] In operation, some embodiments of the push button 300 may be pressed to urge the wedge adapter 112 downward against the biasing element 304. Additionally, in some embodiments, the push button 300 may be tilted or translated proximally downward such that the locking element 302 engages the corresponding locking feature 306. In this manner, the locking element 302 may secure the position of the tip 120 of the catheter 116 within the vasculature. In some embodiments, the locking element 302 may be released from the locking feature 306 in a similar manner. Specifically, in some embodiments, the push button 300 may be pressed such that the wedge adapter 112 is depressed against the biasing element 304. In some embodiments, the push button 300 may be tilted or compressed distally to disengage the locking element 302 from the locking feature 306. The biasing element 304 may then urge the wedge adapter 112 upward to its initial position.

[0041] 4A and 4B illustrate alternative embodiments of the catheter assembly 100 including a push button 300 extending from the wedge adapter 112. As shown in FIG. 4A, in some embodiments, the control feature 122 may include the push button 300 extending from the wedge adapter 112 and through the top surface 408 of the catheter adapter 102 such that the control feature 122 is accessible via the outside of the catheter adapter 102. In some embodiments, the push button 300 may extend through the side wall 204 or the proximal end 104 of the catheter adapter 102. In some embodiments, the push button 300 may extend through a slot 410 in the catheter adapter 102 such that the push button 300 may be translated along the slot 410 to translate the wedge adapter 112 within the lumen 108.

[0042] 4A, the wedge adapter 112 may be disposed within the lumen 108 of the catheter adapter 102 and may include a recess 400 having a size 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 device or mechanism.

[0043] In some embodiments, the recess 400 can be substantially aligned with the distal end 106 of the catheter adapter 102 such that the distal end of the wedge 114 can retain the end 118 of the catheter 116 and the tip 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 can extend substantially perpendicular to the longitudinal axis 110.

[0044] In some embodiments, the wedge adapter 112 can include a locking element 302 for securing the position of the wedge adapter 112 and the wedge 114 within the lumen 108. For example, as shown in FIG. 4A , the locking element 302 can include a proximal portion 404 extending perpendicularly from a bottom end 406 of the wedge adapter 112. In some embodiments, upon actuation of the push button 300, the push button 300 can be translated 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 can engage a recess 414 formed by a shoulder 412 of the lumen 108, thereby disaligning the wedge 114 with the distal end 106 of the catheter adapter 102 and securing the position of the tip 120 of the catheter 116 within the vasculature.

[0045] 4B, the locking element 302 may include legs 402 extending distally from the proximal portion 404 in a direction parallel to the longitudinal axis 110. In some embodiments, depressing the push button 300 downward may also compress the wedge adapter 112 downward, causing the wedge adapter 112 and wedge 114 to become misaligned with the distal end 106 of the catheter adapter 102. In some embodiments, depressing the push button 300 in this manner may cause the legs 402 to align with the channel 410 in the lumen 108.

[0046] In some embodiments, push button 300 can then be translated distally along slot 206, thereby translating legs 402 of wedge adapter 112 distally to engage channel 410 within lumen 108. In some embodiments, this can fix the position of tip 120 of catheter 116 within the vasculature.

[0047] 5 , in some embodiments, the catheter adapter 102 may include a first section 500 including the distal end 106 and a second section 502 including the proximal end 104. In some embodiments, the catheter 116 may extend from the distal end 106 of the first section 500. In some embodiments, the first section 500 may be axially slidable relative to the second section 502. Thus, in some embodiments, the first section 500 may move in a proximal direction 508 relative to the second section 502 to retract the tip 120 of the catheter 116 within the vasculature, or may move in a distal direction 510 relative to the second section 502 to advance the tip 120 of the catheter 116 within the vasculature.

[0048] In some embodiments, a flexible joint 504 may be incorporated between the first section 500 and the second section 502. The flexible joint 504 may comprise a flexible polymer or other suitable material to provide flexible and controlled relative movement between the first section 500 and the second section 502, thereby facilitating the application of traction to the catheter 116. In some embodiments, for example, the flexible joint 504 may comprise a short piece of rubber or other suitable material or device.

[0049] In some embodiments, the catheter assembly 100 may include one or more gripping elements 506 a,b coupled to or integral with the first section 500 and / or the second section 502 to facilitate moving the first section 500 and the second section 502 relative to one another to apply traction to the catheter 116. In some embodiments, the gripping elements 506 a,b may include protrusions, indentations, tabs, handles, ridges and / or textured surfaces, or other suitable features or elements to promote a reliable grip.

[0050] 6 and 6B, in some embodiments, a 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 movement of the catheter adapter 102 can control the position of the tip 120 of the catheter 116 within the vasculature.

[0051] 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 may remain stationary within the vasculature. 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 by adhesive, a bushing, an interference fit, or any other suitable method or device.

[0052] 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 may receive the catheter 116 therethrough. In some embodiments, the outer sleeve 208 may include a length that approximates the length of the catheter 116. In some embodiments, the length of the outer sleeve 208 may be shorter than the length of the catheter 116 such that the tip 120 of the catheter 116 can extend distally beyond the outer sleeve 208.

[0053] In some embodiments, the catheter 116 may be axially slidable within the outer sleeve 208. In some embodiments, the catheter assembly 100 may include a toggle element 602 to facilitate translating the catheter 116 relative to the outer sleeve 208, thereby applying a traction force to the catheter 116 within the vasculature. The toggle element 602 may also reduce the risk of contamination from manipulating the catheter 116 within the vasculature. As shown in FIG. 6A , the catheter adapter 102 may be disposed over a stationary base element 608, and the outer sleeve 208 may be coupled to a distal end 610 of the stationary base element 608 such that the outer sleeve 208 is aligned with the catheter 116 of the catheter adapter 102. In this manner, in some embodiments, the catheter 116 of the catheter adapter 102 may be received by the outer sleeve 208 of the stationary base element 608. In some embodiments, one or more sealing elements 614 a, b may be disposed between the stationary base element 608 and the catheter adapter 102 to seal a fluid path between the catheter 116 and the outer sleeve 208.

[0054] In some embodiments, the toggle element 602 can 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 a stationary base element 608. In some embodiments, the toggle element 602 can axially translate the catheter adapter 102 in a proximal and / or distal direction relative to the stationary base element 608. In some embodiments, the toggle element 602 can laterally rotate the catheter adapter 102 relative to the stationary base element 608.

[0055] 6A and 6B , in some embodiments, depressing the flexible arm 600 compresses the first portion 604 and associated catheter adapter 102 proximally against the stationary base element 608, thereby retracting the catheter 116 relative to the outer sleeve 600. Similarly, in some embodiments, releasing downward pressure on the flexible arm 600 moves the first portion 604 of the flexible arm 600 and 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 second portion 606 of the flexible arm 600 can be manually or automatically manipulated to move the catheter adapter 102 to retract, advance, or rotate the tip 120 of the catheter 116 within the vasculature. In either case, in some embodiments, the outer sleeve 208 can remain fixed within the vasculature so that the insertion site is not affected by movement of the catheter 116.

[0056] 7, in some embodiments, toggle element 602 may include a switch element 700 coupled to catheter 116 and extending through an opening 702 in outer sleeve 208. In some embodiments, a lower end 704 of switch element 700 may be coupled to catheter 116 such that an upper end 706 of switch element 700 can be switched between a first position and a second position to translate catheter 116 relative to outer sleeve 208.

[0057] In some embodiments, a user may toggle the switch element 700 between a first position and a second position to verify the presence of blood flashback in the catheter adapter 102 in each position. In this manner, the switch element 700 may be used to confirm that applying traction to the catheter 116 by retracting and / or advancing the catheter 116 within the vasculature does not compromise the placement of the catheter 116 within the vein.

[0058] 8 , in some embodiments, the catheter adapter 102 may include a side port 800 coupled to an extension set 802. In some embodiments, the stationary base element 608 may be stationary or fixed relative to the patient via, for example, 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 the catheter adapter 102 may 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 a traction force to the catheter 116 within the vasculature.

[0059] In some embodiments, the catheter adapter 102 can include a fixed outer portion 814 that holds a rotatable inner portion 808. The rotatable inner portion 808 can include the wedge adapter 112, the wedge 114, and / or the end 118 of the catheter 116. In some embodiments, the inner portion 808 can include a pin, screw, post 804, or other suitable element coupled to its outer surface and extending perpendicular to the longitudinal axis 110. In some embodiments, the post 804 or other suitable element can extend through a track or groove 806 in the fixed outer portion 814.

[0060] In some embodiments, the inner portion 808 can rotate within the outer portion 814 such that the post 804 rotates within the groove 806 of the outer portion 814. In some embodiments, rotating the catheter adapter 102 can rotate or twist the inner portion 808 relative to the outer portion 814, thereby retracting the catheter 116 within the vasculature. In some embodiments, reversing the direction of rotation of the catheter adapter 102 can advance the inner portion 808 relative to the outer portion 814, thereby advancing the catheter 116 within the vasculature.

[0061] In some embodiments, groove 806 can extend longitudinally along the outer surface of outer portion 814 of catheter adapter 102. In operation, in some embodiments, rotation of inner portion 808 of catheter adapter 102 relative to outer portion 814 of catheter adapter 102 can cause post 804 to translate axially in the proximal direction along groove 806.

[0062] 9A and 9B, in some embodiments, the stationary base element 608 may include one or more retaining bands 900, retaining channels, or other suitable retaining elements for rotatably retaining the catheter adapter 102 relative to the stationary base element 608. In some embodiments, the retaining bands 900 may be centered relative to the stationary base element 608 and extend substantially laterally above the catheter adapter 102. In other words, the retaining bands 900 may extend perpendicularly or diagonally above the catheter adapter 102 relative to its longitudinal axis 110, 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 positioned on opposite sides of the catheter adapter 102 to stabilize the catheter adapter 102 as it moves.

[0063] In some embodiments, one or more retaining bands 900 may be positioned adjacent to the side port 800 of the catheter adapter 102. In some embodiments, the side port 800 may be positioned between one or more retaining bands 900 to stabilize the rotation of the side port 800 within the retaining bands 900. In some embodiments, rotating the side port 800 relative to the stationary base element 608 may rotate the catheter adapter 102 in the same manner. In some embodiments, an extension set 802 may be coupled to the side port 800 to facilitate such rotation. For example, in some embodiments, a user may grasp the extension set 802 to rotate the side port 800 and the associated catheter adapter 102.

[0064] In either case, rotating the catheter adapter 102 in one direction may translate the catheter adapter 102 proximally relative to the stationary base element 608, thereby retracting the catheter 116 within the vasculature. Similarly, rotating the catheter 116 in the opposite direction may translate the catheter adapter 102 distally relative to the stationary base element 608, thereby advancing the catheter 116 within the vasculature.

[0065] 10 , in some embodiments, the catheter assembly 100 may include a traction grip 1000 as a separate feature or a feature 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 to the catheter 116. In some embodiments, the traction grip 1000 may be curved or include another suitable shape to facilitate a reliable grip. In some embodiments, the traction grip 1000 may include one or more roughened or textured surfaces to increase friction and thereby facilitate a reliable grip. In some embodiments, the textured surface may include ridges, bumps, indentations, or other suitable texturing features. In some embodiments, the traction grip 1000 may include one or more markings 1006 to indicate finger placement, thereby promoting consistency in the application of traction.

[0066] 10 , in some embodiments, the traction grip 1000 may include a tall tab 1008 or protrusion integrated with the outer surface 1002 of the catheter adapter 102 at the distal end 106. In some embodiments, the tall tab 1008 may include a distal surface 1004 that is curved proximally to facilitate application of traction to the catheter 116. In some embodiments, the distal surface 1004 may be roughened or otherwise textured, marked with one or more indicator markings 1006 for consistency in the location of traction application.

[0067] All examples and conditional language described herein are intended for educational purposes to aid in understanding the invention and concepts provided by the inventor to further the technology, and should be construed as not being limited to the specifically recited examples and conditions. Although embodiments of the present disclosure have been described in detail, it should be understood that various changes, substitutions, and alterations can be made thereto without departing from the spirit and scope of the disclosed embodiments.

Claims

1. 1. A catheter assembly for opening a fluid pathway, comprising: a catheter adapter including a proximal end, a distal end, and a lumen extending along a longitudinal axis therebetween; a catheter extending from the distal end of the catheter adapter; a stationary base element configured to receive the catheter adapter, wherein movement of the catheter adapter relative to the stationary base element controls the position of the tip of the catheter.

2. The catheter assembly of claim 1 , wherein the catheter adapter translates linearly along a longitudinal axis to control the position of the catheter tip.

3. The catheter assembly of claim 1 , wherein the catheter adapter is configured to rotate transversely relative to the longitudinal axis to control the position of the tip of the catheter.

4. 4. The catheter assembly of claim 3, wherein the catheter adapter comprises a side port coupled to an extension set, the extension set configured to rotate transversely relative to the longitudinal axis to rotate the catheter adapter.

5. 4. The catheter assembly of claim 3, further comprising a post extending through a threaded track of the stationary base element and contacting the catheter adapter, the threaded track extending along a surface of the stationary base element in a direction parallel to the longitudinal axis, and the post axially translating along the threaded track in response to rotation of the catheter adapter.

6. The catheter assembly of claim 1 , further comprising a traction lug coupled to a surface of at least one of the catheter adapter and the stationary base element to facilitate application of traction to the catheter.

7. The catheter assembly of claim 6 , wherein the traction lug includes at least one of a curved distal surface and a textured distal surface.

8. The catheter assembly of claim 1 , wherein the stationary base element is configured to fix the position of the catheter adapter relative to a patient.

9. The catheter assembly of claim 1 , further comprising a toggle element configured to move the catheter relative to the stationary base element.

10. The catheter assembly of claim 9 , wherein the toggle element includes a flexible arm having a first portion coupled to the catheter adapter and a second portion coupled to the stationary base element.

11. The catheter assembly of claim 9 , wherein the toggle element is configured to axially move the catheter relative to the stationary base element.

12. The catheter assembly of claim 9 , wherein the toggle element is configured to rotate the catheter relative to the stationary base element.

13. The catheter assembly of claim 1 , further comprising an outer sleeve extending from the distal end of the catheter adapter, the catheter being movably disposed within at least a portion of the outer sleeve.

14. The catheter assembly of claim 1 , further comprising an outer sleeve extending from a distal end of the stationary base element, the catheter being movably disposed within at least a portion of the outer sleeve.

15. 15. The catheter assembly of claim 13 or claim 14, further comprising one or more sealing elements disposed between the stationary base element and the catheter adapter to seal a fluid path between the catheter and the outer sleeve.

16. The catheter assembly of claim 1 , further comprising one or more retaining bands configured to rotatably retain the catheter adapter relative to the stationary base element.

17. The catheter assembly of claim 1 , wherein the stationary base element includes oppositely disposed wings extending laterally from the catheter adapter.

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