CATHETER TIP CONTROL DEVICE AND RELATED SYSTEMS AND METHODS
20220023592 · 2022-01-27
Inventors
- Megan Scherich (Salt Lake City, UT, US)
- Weston F. Harding (Lehi, UT)
- Curtis H. Blanchard (Riverton, UT, US)
- Yiping Ma (Layton, UT, US)
- John Lackey (West Valley City, UT, US)
Cpc classification
A61B5/15074
HUMAN NECESSITIES
A61M39/20
HUMAN NECESSITIES
A61B5/150992
HUMAN NECESSITIES
International classification
Abstract
A catheter assembly may include a catheter adapter having a proximal end, a distal end, and a lumen extending therebetween. A wedge adapter may be retained within the lumen and have a wedge coupled thereto. The wedge may be configured to retain an end of a catheter such that a tip of the catheter extends through the distal end of the catheter adapter. A control feature may extend through an end or side wall of the catheter adapter. The control feature may be configured to manipulate the wedge to control a position of the tip of the catheter to open a fluid path within a vasculature.
Claims
1. A catheter assembly to open a fluid path, comprising: a catheter adapter comprising a proximal end, a distal end, and a lumen extending along a longitudinal axis therebetween; a wedge adapter retained within the lumen and having a wedge coupled thereto, wherein the wedge is configured to retain an end of a catheter such that a tip of the catheter extends through the distal end of the catheter adapter; and a control feature extending from the wedge adapter and through one of the proximal end and a side wall of the catheter adapter, wherein the control feature is configured to manipulate the wedge to control a position of a tip of the catheter to open a fluid path.
2. The catheter assembly of claim 1, wherein the end of the catheter is coupled to the wedge via an interference fit.
3. The catheter assembly of claim 1, wherein the wedge is coupled to the wedge adapter via one of an interference fit and an adhesive.
4. The catheter assembly of claim 1, wherein the control feature comprises at least one of a tab, a handle, a button, and a dial.
5. The catheter assembly of claim 4, wherein at least one of the tab and the handle is configured to move in a proximal direction to retract the tip of the catheter relative to the distal end of the catheter adapter, and configured to move in a distal direction to advance the tip 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 be depressed against the wedge to control the position of the tip of the catheter.
7. The catheter assembly of claim 4, wherein the dial is configured to rotate in a transverse direction relative to the longitudinal axis to control the position of the tip of the catheter.
8. The catheter assembly of claim 1, further comprising a lock element to engage at least one of the control feature and the wedge adapter to secure the position of the tip of the catheter.
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 disposed proximal to the septum.
10. The catheter assembly of claim 1, wherein the catheter adapter comprises a first section comprising the distal end and a second section comprising the proximal end, wherein the first section is slidable relative to the second section 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 therethrough, wherein the catheter is slidable within the outer sleeve.
12. The catheter assembly of claim 11, further comprising a toggle 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 depressing the toggle element advances the catheter relative to the outer sleeve, and wherein releasing the toggle element retracts the catheter relative to the outer sleeve.
14. A catheter assembly to open a fluid path, comprising: 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.
15. The catheter assembly of claim 14, wherein the catheter adapter is linearly translated along the longitudinal axis to control the position of the tip of the catheter.
16. The catheter assembly of claim 14, wherein the catheter adapter is configured to rotate in a transverse direction relative to the longitudinal axis to control the position of the tip of the catheter.
17. The catheter assembly of claim 16, the catheter adapter comprising a side port coupled to an extension set, wherein the extension set is configured to rotate in a transverse direction relative to the longitudinal axis to rotate the catheter adapter.
18. The catheter assembly of claim 16, further comprising a post extending through a screw track of the stationary base element and contacting the catheter adapter, wherein the screw track extends along a surface of the stationary base element in a direction parallel to the longitudinal axis, and wherein the post is axially translated along the screw track in response to rotation of the catheter adapter.
19. The catheter assembly of claim 14, further comprising a traction projection 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.
20. The catheter assembly of claim 19, wherein the traction projection comprises at least one of a curved and a textured distal surface.
Description
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0022] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
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DETAILED DESCRIPTION
[0037] As used in this specification, the term “distal” refers to a direction away from a clinician who would place the device into contact with a patient, and nearer to the patient. The term “proximal” refers to a direction nearer to the clinician who would place the device into contact with the patient, and farther away from the patient. Thus, for example, the end of a catheter first touching the body of the patient is the distal end, while the opposite end of the catheter is the proximal end of the catheter.
[0038] Referring now to
[0039] An example 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 with reference to
[0040] In some embodiments, a distal end of the wedge 114 may be configured to retain an end 118 of the catheter 116. In some embodiments, for example, the catheter 116 may include an inner diameter that is equal to or greater than a diameter of the wedge 114. In some embodiments, the diameter of the wedge 114 may gradually increase in the proximal direction along the wedge 114 to facilitate coupling the catheter 116 to the wedge 114 via a press 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 coupled directly to the catheter adapter 102 by an adhesive or other suitable element.
[0041] In some embodiments, the catheter assembly 100 may include a control feature 122 to manipulate a 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 feature 122 may be used to open a fluid pathway by positioning the tip 120 of the catheter 116 to avoid or clear obstructions, thus providing access to the vasculature of the patient without any additional needle sticks. For example, in some embodiments, the control feature 122 may control the position of the tip 120 of the catheter 116 to clear the pathway for collecting a blood sample. In some embodiments, the catheter assembly 100 may be used for needle-free blood collection and/or fluid infusion.
[0042] As shown in
[0043] Thus, in operation, a user may grasp and pull the tab 124 in a proximal direction along the longitudinal axis 110 to translate the wedge adapter 112 in a proximal direction along the longitudinal axis 110. In some embodiments, the tab 124 or other control feature 122 may be pulled or extended in a proximal direction beyond the proximal end 104 of the catheter adapter 102. In some embodiments, translation of the wedge adapter 112 may thus translate the wedge 114 in a proximal direction along the longitudinal axis 110 to retract the tip 120 of the catheter 116 within the vasculature. Similarly, in some embodiments, the tab 124 or other control feature 122 may be pushed or moved in a distal direction along the longitudinal axis 110 to thereby translate the wedge adapter 112 and the wedge 114 in a distal direction to advance the tip 120 of the catheter 116 within the vasculature.
[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 integrated with the tab 124. In operation, in some embodiments, the dial 126 may rotate the wedge adapter 112 and wedge 114 in a transverse direction 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 maneuver the catheter 116 as desired. 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, combined axial and rotational movement of the control feature 122 may maneuver the tip 120 of the catheter 116 in any direction within the vasculature.
[0045] As illustrated 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 path. In some embodiments, the control feature 122 and/or the wedge adapter 112 may extend through the fluid seal 128 and permit movement of the control feature 122 relative thereto. In some embodiments, the fluid seal 128 may include silicone, rubber, an 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 aperture, slit, or the like to accommodate the control feature 122 and/or 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 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 may be received within the outer sleeve 130 and may 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 an independent catheter 116 without an outer sleeve 130. In some embodiments, the catheter 116 and/or the outer sleeve 130 may include an antithrombogenic material to reduce the formation of thrombus.
[0047] Referring now to
[0048] As shown in
[0049] In some embodiments, the slot 206 may extend along an outer surface 210 of the catheter adapter 102 side wall 204 in a direction transverse to the longitudinal axis 110. In some embodiments, the slot 206 may comprise 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 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 catheter 116 tip 120 within the vasculature.
[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, as shown in
[0051] Referring now to
[0052] 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 urge the wedge 114 and end 118 of the catheter 116 in a downward direction, thereby causing the tip 120 of the catheter 116 to move in an upward direction within the vasculature.
[0053] In some embodiments, the wedge adapter 112 may include a biasing element 304 or spring disposed between the wedge adapter 112 and the catheter adapter 102 such that depressing the push button 300 compresses the biasing element 304. Similarly, releasing the push button 300 may release compression of the biasing element 304 such that the biasing element 304 urges the wedge adapter 112 in an upward direction to its initial starting position.
[0054] In some embodiments, the wedge adapter 112 may include a lock element 302 to selectively secure a position of the wedge adapter 112 with respect to the catheter adapter 102. In some embodiments, as shown in
[0055] In operation, some embodiments of the push button 300 may be depressed to urge the wedge adapter 112 downward against the biasing element 304. Further, in some embodiments, the push button 300 may be tilted downward or translated in a proximal direction such that the lock element 302 engages the corresponding lock feature 306. In this manner, the lock element 302 may secure the position of the tip 120 of the catheter 116 within the vasculature. In some embodiments, the lock element 302 may be released from the lock feature 306 in a similar manner. Specifically, in some embodiments, the push button 300 may be depressed such that the wedge adapter 112 is depressed against the biasing element 304. In some embodiments, the push button 300 may be tilted or urged in a distal direction to disengage the lock element 302 from the lock feature 306. The biasing element 304 may then urge the wedge adapter 112 upward to its initial position.
[0056]
[0057] As shown in
[0058] In some embodiments, the recess 400 may substantially align with the distal end 106 of the catheter adapter 102 such that the distal end of the wedge 114 may retain the end 118 of the catheter 116 and the tip 120 of the catheter 116 may extend through the distal end 106 of the catheter adapter 102. As shown, in some embodiments, the wedge adapter 112 may extend substantially perpendicularly relative to the longitudinal axis 110.
[0059] In some embodiments, the wedge adapter 112 may include a lock element 302 to secure a position of the wedge adapter 112 and wedge 114 within the lumen 108. For example, as shown in
[0060] In some embodiments, as shown in
[0061] In some embodiments, the push button 300 may then be translated in a distal direction along the slot 206 to thereby translate the leg 402 of the wedge adapter 112 in a distal direction to engage the channel 410 within the lumen 108. In some embodiments, this may secure a position of the tip 120 of the catheter 116 within the vasculature.
[0062] Referring now to
[0063] 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 flexibility and controlled relative motion 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 include a short piece of rubber or other suitable material or device.
[0064] In some embodiments, the catheter assembly 100 may include one or more grip elements 506a, b coupled to or integrated 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 each other to apply traction to the catheter 116. In some embodiments, the grip element 506a, b may include a projection, an indentation, a tab, a handle, a raised and/or textured surface, or other suitable feature or element to promote a reliable grip.
[0065] Referring now to
[0066] In some embodiments, an 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 which may remain stationary within the vasculature. In some embodiments, an end 612 of the outer sleeve 208 may be coupled to the catheter adapter 102 or stationary base element 608 via an adhesive, a bushing, an interference fit, or by any other suitable method or device.
[0067] In some embodiments, the outer sleeve 208 may include an inner diameter sufficient to accommodate an 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 approximating a 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 tip 120 of the catheter 116 may extend distally beyond the outer sleeve 208.
[0068] 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 traction to the catheter 116 within the vasculature. The toggle element 602 may also reduce a risk of contamination from manipulating the catheter 116 within the vasculature. As shown in
[0069] In some embodiments, the toggle 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 toggle element 602 may 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 may rotate the catheter adapter 102 transversely relative to the stationary base element 608.
[0070] As shown in
[0071] Referring now to
[0072] In some embodiments, a user may toggle the switch element 700 between the first position and the second position to verify the presence of blood flashback within 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 will not compromise placement of the catheter 116 in the vein.
[0073] Referring now to
[0074] In some embodiments, the catheter adapter 102 may include a fixed outer portion 814 retaining a rotatable inner portion 808. The rotatable inner portion 808 may include the wedge adapter 112, the wedge 114, and/or the end 118 of the catheter 116. In some embodiments, the inner portion 808 may include a pin, screw, post 804, or other suitable element coupled to an exterior surface thereof and extending in a perpendicular direction relative 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 such that the post 804 turns within the groove 806 of the outer portion 814. In some embodiments, rotation of the catheter adapter 102 may 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 may advance the inner portion 808 relative to the outer portion 814, thereby advancing the catheter 116 within the vasculature.
[0076] In some embodiments, the groove 806 may extend longitudinally along an exterior 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 post 804 to be axially translated along the groove 806 in a proximal direction.
[0077] Referring now to
[0078] In some embodiments, one or more retaining bands 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 the retaining bands 900 to stabilize 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 cause the catheter adapter 102 to rotate in the same manner. In some embodiments, the 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 associated catheter adapter 102.
[0079] In any case, rotating the catheter adapter 102 in one direction may translate the catheter adapter 102 in a proximal direction relative to the stationary base element 608, thereby retracting the catheter 116 within the vasculature. Similarly, rotating the catheter 116 in an opposite direction may translate the catheter adapter 102 in a distal direction relative to the stationary base element 608, thereby advancing the catheter 116 within the vasculature.
[0080] Referring now to
[0081] As shown in
[0082] All examples and conditional language recited herein are intended for pedagogical objects to aid the reader in understanding the present disclosure and the concepts contributed by the inventor to furthering the art, and are to be construed as being without limitation to such specifically recited examples and conditions. Although embodiments of the present disclosure have been described in detail, it should be understood that the various changes, substitutions, and alterations could be made hereto without departing from the spirit and scope of the present disclosure.