CATHETER ASSEMBLY WITH A SLIDABLE SEPTUM AND RELATED SYSTEMS AND METHODS
20210299429 · 2021-09-30
Inventors
Cpc classification
A61M25/0637
HUMAN NECESSITIES
A61M25/0631
HUMAN NECESSITIES
A61M2039/0036
HUMAN NECESSITIES
A61B5/150992
HUMAN NECESSITIES
International classification
Abstract
A catheter assembly configured to selectively isolate a blood fluid pathway from a priming solution fluid pathway. The catheter assembly may include a catheter adapter, which may include a distal end, a proximal end, and a lumen extending therethrough. A catheter may extend from the distal end and a side port may be disposed between the distal end and the proximal end. A septum may be positioned within the lumen and aligned with the side port. The septum may provide a seal between the side port and the catheter in the distal position. The septum may be configured to slide from the distal position to a proximal position proximal to the side port. In the proximal position, the side port may be in fluid communication with the catheter. The catheter assembly may increase a likelihood of obtaining a quick and clear indication of flashback to confirm proper catheter placement.
Claims
1. A catheter assembly, comprising: a catheter adapter, comprising a distal end, a proximal end, a lumen extending through the distal end and the proximal end, and a side port between the distal end of the catheter adapter and the proximal end of the catheter adapter; a catheter extending from the distal end of the catheter adapter; and a septum disposed within the lumen at a distal position aligned with the side port, wherein in response to the septum being in the distal position, the septum provides a seal between the side port and the catheter, wherein the septum is configured to slide from the distal position to a proximal position proximal to the side port, wherein in response to the septum being in the proximal position, the side port is in fluid communication with the catheter.
2. The catheter assembly of claim 1, further comprising a puller element disposed within the lumen, wherein the puller element comprises a distal end coupled to the septum and a proximal end configured to couple to a blood collection set.
3. The catheter assembly of claim 2, wherein the catheter adapter further comprises a slot, wherein a proximal end of the slot comprises a stop, wherein the puller element further comprises an extension extending through the slot and configured to contact the stop in response to the septum sliding from the distal position to the proximal position.
4. The catheter assembly of claim 3, wherein the extension is coupled to a push tab.
5. The catheter assembly of claim 1, wherein the catheter adapter comprises an air vent, wherein an outer surface of the septum comprises an annular groove, wherein in response to the septum being in the distal position, the side port is in fluid communication with the annular groove and the air vent.
6. A catheter system, comprising: a catheter assembly, comprising: a catheter adapter, comprising a distal end, a proximal end, a lumen extending through the distal end and the proximal end, and a side port between the distal end of the catheter adapter and the proximal end of the catheter adapter; a catheter extending from the distal end of the catheter adapter; a stop within the lumen; and a septum disposed within the lumen at a distal position aligned with the side port, wherein in response to the septum being in the distal position, the septum provides a seal between the side port and the catheter; and a needle assembly, comprising: a needle hub coupled to the proximal end of the catheter adapter; an introducer needle, comprising a sharp distal tip, a proximal end, and a needle feature disposed between the sharp distal tip and the proximal end, wherein the proximal end of the introducer needle is secured within the needle hub, wherein in response to withdrawal of the introducer needle in a proximal direction a first amount, the needle feature is configured to contact the septum and slide the septum from the distal position to a proximal position, wherein in response to the septum being in the proximal position, the side port is in fluid communication with the catheter and the stop contacts the septum, wherein in response to withdrawal of the introducer needle in the proximal direction more than the first amount, the needle feature is configured to move proximally with respect to the septum.
7. The catheter assembly of claim 6, wherein the needle feature comprises a bump.
8. The catheter assembly of claim 1, wherein the catheter adapter comprises an air vent, wherein an outer surface of the septum comprises an annular groove, wherein in response to the septum being in the distal position, the side port is in fluid communication with the annular groove and the air vent.
9. The catheter assembly of claim 8, wherein the air vent forms the stop.
10. A method, comprising: priming a catheter system with a priming solution, wherein the catheter system comprises: a catheter assembly, comprising: a catheter adapter, comprising a distal end, a proximal end, a lumen extending through the distal end and the proximal end, a side port between the distal end of the catheter adapter and the proximal end of the catheter adapter, and an air vent extending through a wall of the catheter adapter; a catheter extending from the distal end of the catheter adapter; and a septum disposed within the lumen at a distal position aligned with the side port, wherein in response to the septum being in the distal position, the septum provides a seal between the side port and the catheter, wherein an outer surface of the septum comprises an annular groove, wherein in response to the septum being in the distal position, the side port is in fluid communication with the annular groove and the air vent, wherein the septum is configured to slide from the distal position to a proximal position proximal to the side port, wherein in response to the septum being in the proximal position, the side port is in fluid communication with the catheter; and a needle assembly, comprising: a needle hub coupled to the proximal end of the catheter adapter; and an introducer needle, comprising a sharp distal tip, a proximal end, and a notch, wherein the proximal end of the introducer needle is secured within the needle hub; and after priming the catheter system, inserting the introducer needle and the catheter into vasculature, wherein in response to the introducer needle being inserted into the vasculature, blood flows into the sharp distal tip of the introducer needle, through the notch into a space between the introducer needle and the catheter, and proximate the septum, wherein the blood is not in fluid communication with the priming solution.
11. The method of claim 10, wherein the introducer needle further comprises a needle feature disposed between the sharp distal tip and the proximal end of the introducer needle, further comprising after inserting the introducer needle and the catheter into the vasculature, withdrawing the introducer needle in a proximal direction a first amount, wherein in response to withdrawing the introducer needle in the proximal direction the first amount, the needle feature contacts the septum and slides the septum from the distal position to the proximal position.
12. The method of claim 11, further comprising after withdrawing the introducer needle in the proximal direction the first amount, withdrawing the introducer needle in the proximal direction more than the first amount, wherein in response to withdrawal of the introducer needle more than the first amount, the needle feature moves proximally with respect to the septum.
13. The catheter assembly of claim 11, wherein the needle feature comprises a bump.
14. The method of claim 10, wherein the catheter assembly further comprises a puller element disposed within the lumen, wherein the puller element comprises a distal end coupled to the septum and a proximal end configured to couple to a blood collection set.
15. The method of claim 14, wherein the catheter adapter further comprises a slot, wherein a proximal end of the slot comprises a stop, wherein the puller element further comprises an extension extending through the slot and configured to contact the stop in response to the septum sliding from the distal position to the proximal position.
16. The method of claim 15, further comprising: removing the needle assembly from the catheter system; coupling a distal end of a housing of a blood collection set to the proximal end of the puller element, wherein the blood collection set comprises: the housing, comprising a distal end, a proximal end, and a slot; a cannula hub, comprising a wing extending through the slot, wherein the cannula hub is slidable with respect to the housing between a retracted position and an advanced position; a cannula extending distally from the cannula hub; an extension tube, comprising a distal end coupled to the proximal end of the cannula hub; and a blood collection device coupled to a proximal end of the extension tube; and after coupling the distal end of the housing of the blood collection set to the proximal end of the puller element, gripping the wing to slide the cannula hub from the retracted position to the advanced position, wherein the cannula is disposed within the housing in response to the cannula hub being in the retracted position, wherein in response to the cannula hub being in the advanced position, the cannula extends through the distal end of the housing, the puller element, and the septum.
17. The method of claim 16, further comprising after gripping the wing to slide the cannula hub from the retracted position to the advanced position, collecting a blood sample within the blood collection set.
18. The method of claim 17, further comprising after collecting the blood sample within the blood collection set, gripping the wing to slide the cannula hub from the advanced position to the retracted position.
19. The method of claim 17, further comprising after collecting the blood sample within the blood collection set, moving the housing proximally until the extension contacts the stop, wherein in response to moving the housing proximally, the septum slides from the distal position to the proximal position, wherein in response to the extension contacting the stop, the housing is uncoupled from the puller element.
20. The method of claim 18, wherein the extension is coupled to a tab, wherein moving the housing proximally until the extension contacts the stop comprises gripping the housing and the tab.
Description
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0028] 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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DESCRIPTION OF EMBODIMENTS
[0046] Referring now to
[0047] In some embodiments, a catheter system 100 may include a catheter assembly 101. In some embodiments, a catheter assembly 101 may include a catheter adapter 102, which may include a lumen 108 extending longitudinally between a distal end 104 and a proximal end 106 thereof. In some embodiments, the lumen 108 may have an inner diameter at least slightly larger than an outer diameter of a catheter 110, which may be over-the-needle. In some embodiments, the catheter 110 may be coupled to the distal end 104 of the catheter adapter 102. In some embodiments, the catheter 110 may be secured and mechanically sealed to the catheter adapter 102 by way of, for example, a threaded connection, a press fit, a wedge, or by any other means known to those in the art.
[0048] In some embodiments, the inner diameter of the lumen 108 may increase between the distal end 104 and the proximal end 106 of the catheter adapter 102. In some embodiments, an inside diameter of the catheter adapter 102 at the distal end 104 may substantially match an outside diameter of an associated catheter 110 to tightly engage an introducer needle 112 therein. This may prevent peel back of the catheter 110 during insertion of the catheter 110 into a blood vessel. In some embodiments, the proximal end 106 of the catheter adapter 102, on the other hand, may include a substantially larger inside diameter to receive and/or engage a blood collection set or other peripheral device.
[0049] In some embodiments, a side port 132 may extend from the catheter adapter 102 and communicate with the lumen 108. In this manner, the side port 132 may provide an independent fluid pathway between the catheter 110 and an infusion set or other infusion device coupled to the side port 132. In some embodiments, the infusion set may be coupled to a needleless access connector 136 or directly to an adapter disposed at a proximal end of an extension tube extending from the side port 132.
[0050] In some embodiments, the side port 132 may be used to provide an independent fluid pathway for dispensing a priming fluid or solution, such as saline or the drug intended for infusion, to prime the catheter system 100. Similarly, in some embodiments, the side port 132 may provide an independent fluid pathway to infuse fluids into a patient's vasculature. Fluids may include, for example, saline solution, various medicaments, total parenteral nutrition, and the like.
[0051] In some embodiments, a septum 114 may be disposed within the lumen 108 of the catheter adapter 102. In some embodiments, the septum 114 may include a substantially resilient and fluid impervious material to facilitate creating an effective fluid seal between the side port 132 and the lumen 108. In some embodiments, the septum 114 may include a material, such as silicone, foam, rubber, a composite, or the like. In some embodiments, the material may be configured to expand or otherwise substantially occupy the interior space or volume of the lumen 108. In some embodiments, the septum 114 and/or the lumen 108 may include a coating or lubricant to facilitate the ability of the septum 114 to slide within the lumen 108 and/or seal the fluid pathway between the lumen 108 and the side port 132.
[0052] Further, in some embodiments, the septum 114 may include dimensions sufficient to selectively occlude and seal a fluid pathway between the side port 132 and the lumen 108. In some embodiments, the septum 114 may include a substantially circular cross-section having a diameter substantially matching a diameter of the lumen 108 of the catheter adapter 102. The septum 114 may further include a length and height sufficient to occlude a distal opening 138 of the side port 132. Of course, the septum 114 may include any shape and/or dimensions to seal a fluid pathway between the side port 132 and the lumen 108.
[0053] As discussed in more detail below, in some embodiments, the septum 114 may be configured to slide and/or otherwise move within the lumen 108 between a distal position and a proximal position. In some embodiments, in the distal position, the septum 114 may be substantially aligned with the side port 132 such that the septum 114 provides a seal between the side port 132 and the catheter 110. In this manner, a fluid pathway between the distal end 104 and the proximal end 106 of the catheter adapter 102 may be isolated to prevent contamination from current or residual fluid in the side port 132. In the proximal position, on the other hand, the septum 114 may create a pathway between the side port 132 and the catheter adapter 102 to facilitate the side port 132 to be in fluid communication with the catheter 110.
[0054] In some embodiments, manipulating a position of the septum 114 in this manner may prevent one fluid from contaminating or diluting another. In some embodiments, priming solution may be dispensed via the side port 132 to prime the catheter system 100. In some embodiments, the fluid pathway used to dispense the priming solution may be sealed with respect to the lumen 108 of the catheter adapter 102. This may enable pure or undiluted blood to be drawn from a cannula of a blood collection set (see, for example, the blood collection set 801 of
[0055] Of course, one skilled in the art will recognize that embodiments of the present disclosure are not limited to any particular fluids and/or number or orientation of fluid pathways, as all fluids and any number and/or orientations of fluid pathways are contemplated herein. For example, a length of the septum 114 may be extended or the dimensions of the septum 114 may be modified to enable more than one side port 132 to be sealed simultaneously. In other embodiments, the side port 132 orientation may be varied to create any number of fluid pathways. For example, two or more side ports 132 may be disposed on opposite sides of the catheter adapter 102 such that translating the septum 114 within the lumen 108 may expose more than one side port 132 at a time.
[0056] In some embodiments, a puller element 116 may be disposed within the lumen 108 such that a distal end 118 of the puller element 116 is positioned substantially adjacent to a proximal end of the septum 114. In some embodiments, a proximal end 120 of the puller element 116 may be configured to couple to, for example, a needle hub 134 and/or the blood collection set. In other embodiments, the distal end 118 of the puller element 116 may be integrated with or coupled to the proximal end of the septum 114. In some embodiments, the puller element 116 and the septum 114 may be monolithically formed as a single unit. In some embodiments, the distal end 118 of the puller element 116 may be positioned substantially adjacent to the proximal end of the septum 114.
[0057] In some embodiments, the catheter adapter 102 may include a slot 124 to receive at least a portion of the puller element 116. For example, in some embodiments, the puller element 116 may include an extension 126 extending through the slot 124. In some embodiments, a push tab 130 may be coupled to an end of the extension 126 to enable manual translation of the puller element 116 through a wall of the catheter adapter 102.
[0058] In some embodiments, a proximal end of the slot 124 may include a stop 128, such as a narrowing, edge, ridge, or any other suitable feature that is integrated with or coupled to the slot 124. In some embodiments, the stop 128 may contact the extension 126 when the septum 114 is moved from the distal position to the proximal position.
[0059] Referring now to
[0060] As illustrated in
[0061] In certain embodiments, an air vent 304 may be integrated with or coupled to an aperture in the outer surface of the catheter adapter 102 to facilitate air to flow between the lumen 108 of the catheter adapter 102 and an external environment. Some embodiments of an air vent 304 may include a hydrophobic membrane to avoid any interference with priming fluid or any other fluid or solution. In some embodiments, the hydrophobic membrane may be permeable to air but not priming fluid or any other fluid or solution.
[0062] In some embodiments, an outer surface of the septum 114 may include an annular groove 306 disposed between its distal end and its proximal end. This design may relieve frictional force when the septum 114 is translated between the distal position and the proximal position. In some embodiments, the annular groove 306 may also create a distal edge 308 at the distal end of the septum 114 and proximal edge 310 at the proximal end of the septum 114. In some embodiments, when the septum 114 is in the distal position, the side port 132 may be in fluid communication with the annular groove 306 and the air vent 304. In certain embodiments, the air vent 304 may form a stop to contact the proximal edge 310 of the septum 114 within the lumen 108. In some embodiments, the stop may secure the position of the septum 114 with respect thereto and prevent further translation of the septum 114 in a distal direction.
[0063] In some embodiments, the needle feature 204 may be configured to catch on a distal end of the septum 114. In some embodiments, withdrawing the introducer needle 112 from the catheter adapter 102 in the proximal direction may urge the needle feature 204 against a distal end of the septum 114. In some embodiments, a withdrawal force exerted on the introducer needle 112 in the proximal direction may in turn cause the needle feature 204 to passively force the septum 114 to slide or otherwise move from the distal position to the proximal position.
[0064] In some embodiments, in the proximal position, as illustrated in
[0065] In some embodiments, the withdrawal force exerted on the introducer needle 112 in the proximal direction may exceed a force needed to move the septum 114 to the proximal position, causing the needle feature 204 to continue to move proximally through the septum 114. In this manner, the needle feature 204 may be translated through a proximal end of the septum 114, thereby enabling the introducer needle 112 to be removed from the catheter adapter 102.
[0066] Referring now to
[0067] In some embodiments, the puller element 116 may be positioned adjacent to the septum 114 within the lumen 108. In some embodiments, a housing or actuator 800 of a blood collection set 801 may engage a proximal end of the puller element 116 and thereby urge the puller element 116 in a distal direction in response to a force applied in the proximal direction by the clinician. In some embodiments, in response to urging of the puller element 116 in the distal direction, a distal end of the puller element 116 coupled to the proximal end of the septum 114 may automatically slide the septum 114 proximally, such as to the proximal position.
[0068] In some embodiments, a proximal end of the puller element 116 may include a male or female connector portion, and a distal end of the actuator 800 may include a male or female connector portion. In some embodiments, a proximal end of the septum 114 may include a male or female connector portion and a distal end of the puller element 116 may include a male or female connector portion. As illustrated, for example, a proximal end of the puller element 116 may include a female connector portion and a distal end of the actuator 800 may include a male connector portion. As also illustrated, for example, a proximal end of the septum 114 may include a female connector portion and a distal end of the puller element 116 may include a male connector portion.
[0069] In some embodiments, in operation, the actuator 800 may be inserted into the proximal end 106 of the catheter adapter 102 such that the male connector portion of the actuator 800 engages the female connector portion of the puller element 116. In some embodiments, the actuator 800 may then be urged in the distal direction, causing the male connector portion of the puller element 116 to engage the female connector portion of the septum 114. In some embodiments, continuing to urge the actuator in the distal direction in this manner may cause the septum 114 to slide from the proximal position to the distal position. In some embodiments, as illustrated in
[0070] Referring now to
[0071] In some embodiments, the septum 114 may be initially positioned in the distal position to facilitate a priming process to reduce or eliminate air from the catheter assembly 101. In some embodiments, in the distal position, the septum 114 may occlude the lumen 108 such that priming solution cannot enter or prime the lumen 108 or contact the catheter 110. In some embodiments, preventing exposure of the catheter 110 to priming fluid in this manner may prevent softening of the catheter 110 during insertion. In some embodiments, however, the septum 114 may include an annular groove 306 to permit priming fluid to flow from the side port 132 and across the annular groove 306 to prime a distal portion of the lumen 108 corresponding to the annular groove 306. In some embodiments, the priming fluid may also prime a portion of the air vent 304 exposed to the lumen 108. In some embodiments, the air vent 304 may include a hydrophobic membrane or other suitable air vent to seal the priming fluid within the lumen 108.
[0072] Referring now to
[0073] Referring now to
[0074] Referring now to
[0075] In some embodiments, the blood collection set 801 may include an extension tube 1117 (see
[0076] In some embodiments, after collecting the blood sample within the blood collection device 1118 or set 801, the wing 1116 may be gripped and moved along the slot 1110 to slide the cannula 1115 between the advanced position and the retracted position. In some embodiments, the distal end of the cannula 1115 may be disposed within the actuator 800 in response to the cannula 1115 being in the retracted position.
[0077] Referring now to
[0078] All examples and conditional language recited herein are intended for pedagogical objects to aid the reader in understanding the invention 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 inventions 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 invention.