A catheter is commonly used to infuse fluids into vasculature of a patient. For example, the catheter may be used for infusing normal saline solution, various medicaments, or total parenteral nutrition. The catheter may also be used for withdrawing blood from the patient.
The catheter may include an over-the-needle peripheral intravenous (“IV”) catheter. In this case, the catheter may be mounted over an introducer needle having a sharp distal end. The catheter and the introducer needle may be assembled so that the distal end of the introducer needle extends beyond the distal end of the catheter with the bevel of the needle facing up away from skin of the patient. The catheter and the introducer needle are generally inserted at a shallow angle through the skin into vasculature of the patient.
In order to verify proper placement of the introducer needle and/or the catheter in the blood vessel, a clinician generally confirms that there is “flashback” of blood in a flashback chamber of the catheter assembly. Once placement of the needle has been confirmed, the clinician may temporarily occlude flow in the vasculature and remove the needle, leaving the catheter in place for future blood withdrawal or fluid infusion.
Catheter functionality, however, may be impeded for several reasons, particularly when there is a prolonged dwelling time of the catheter within the vasculature. For example, when the catheter is left inserted in the patient for more than a day, the catheter may become susceptible to complications and obstructions that impede fluid flow. For example, the catheter may become occluded at a tip of the catheter due to the presence of fibrin sheath, thrombus, vein walls, or valves. Further, if the catheter is fenestrated (i.e., having holes near the tip to decrease fluid velocity at the tip and improve blood draw success), the catheter tends to become occluded faster than a non-fenestrated catheter.
The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in environments such as those described above. Rather, this background is provided to illustrate one example technology area where some implementations described herein may be practiced.
The present disclosure relates generally to vascular access devices, systems, and methods to infuse fluids and/or collect blood from the vasculature of a patient. In particular, the present disclosure relates to systems, devices and methods to facilitate catheter functionality and blood draw success. In some embodiments, various features of a vascular access device may facilitate one or more of the following: repositioning a distal tip of a catheter within the vasculature to open a fluid path, selectively opening and closing the distal tip, and selectively opening and closing one or more fenestrations.
In some embodiments, the vascular access device may include the catheter and an obturator slidably positioned within the lumen of the catheter. In some embodiments, the catheter may include a proximal end, a distal tip, a sidewall defining the lumen between the proximal end and the distal tip, and a first fluid pathway through the opening. In some embodiments, the distal tip may include an opening. In some embodiments, the sidewall of the catheter may include a fenestration forming a second fluid pathway, which may extend through the fenestration.
In some embodiments, the obturator may include a distal end with an outer diameter configured to form an interference fit with an inner diameter of the distal tip of the catheter, which may correspond to an inner diameter of the opening of the distal tip. In some embodiments, the obturator may include a tubular shaft and a third fluid pathway extending through a length of the tubular shaft.
In some embodiments, the obturator may be positioned with the lumen of the catheter such that a fluid is blocked or prevented from flowing through the second fluid pathway. In some embodiments, the obturator may be positioned within the lumen of the catheter such that a fluid is permitted to flow through the second fluid pathway. In some embodiments, a fluid is permitted to flow through the first and third fluid pathways. In some embodiments, a particular fluid pathway, such as, for example, the first fluid pathway or the second fluid pathway, can be cleared by repositioning the obturator within the lumen of the catheter.
In some embodiments, an obturator may include the tubular shaft having a hole formed through a sidewall of the tubular shaft and a fourth fluid pathway through the hole. In some embodiments, the obturator may be positioned within the lumen of the catheter such that a fluid is permitted to flow through the second and fourth fluid pathways. In some embodiments, the obturator may be positioned within the lumen of the catheter such that a fluid is blocked or prevented from flowing through the second and fourth fluid pathways. In some embodiments, a fluid is permitted to flow through the first and third fluid pathways. In some embodiments, moving or repositioning the obturator within the lumen of the catheter causes a distal tip of the catheter to move.
In some embodiments, the distal end of the obturator may be solid or closed such that a fluid is blocked or prevented from flowing through the distal end of the obturator. In some embodiments, the obturator may be positioned within the lumen of the catheter such that a fluid is blocked or prevented from flowing through the first or second fluid pathways. In some embodiments, the obturator may be positioned within the lumen of the catheter such that a fluid flows through the second fluid pathway. In some embodiments, the obturator may be positioned within the lumen of the catheter such that a fluid is permitted to flow through the first and second fluid pathways.
In some embodiments, an obturator may include a body with an outer diameter configured to slide within the lumen of a catheter. In some embodiments, the outer diameter of the body forms the interference fit with the inner diameter of the distal tip of a catheter. In some embodiments, the body is significantly smaller than the inner diameter of the catheter of the distal tip of the catheter. In some embodiments, the body is rounded or spherical to prevent injury to vasculature when the body is moved distal the distal tip of the catheter. In some embodiments, the body is a soft spring with good compliance. In some embodiments, the obturator further may include a guidewire attached to a distal end of the body. In some embodiments, the guidewire attaches to a place other than the center of the body.
In some embodiments, the guidewire may include a shaped portion with a maximum height that is greater than the inner diameter of the distal tip of the catheter. In some embodiments, the shaped portion of the guidewire is configured to contact an inner wall surface forming the lumen of the catheter to temporarily deform a static conformation of the catheter at a point of contact between the shaped portion of the guidewire and the inner wall surface forming the lumen of the catheter.
In some instances, the obturator may cause the distal tip of the catheter to move away from an inner sidewall of a patient's vein. In some instances, moving or repositioning the obturator causes the distal tip of the catheter to move away from an object or surface occluding the distal tip of the catheter. In some embodiments, the obturator may be positioned within the lumen of the catheter such that a fluid is blocked or prevented from flowing through the first fluid pathway. In some embodiments, the obturator may be positioned within the lumen of the catheter such that a fluid is permitted to flow through the first fluid pathway.
In some embodiments, moving or repositioning the guidewire distally, proximally, and/or rotationally causes the distal tip of the catheter to move. In some embodiments, the body of the obturator may include a tubular shaft and a third fluid pathway extending through a length of the tubular shaft. In some embodiments, the body of the obturator comprises a hole in a sidewall of the tubular shaft and a fourth fluid pathway through the hole. In some embodiments, the body comprises a proximal portion with an outer diameter configured to form an interference fit with the inner diameter of a distal tip of a catheter and a distal portion with an outer diameter that is larger than the outer diameter of the proximal portion. In some embodiments, the body comprises a metal part and a plastic part. In some embodiments, the guidewire attaches to the metal part. In some embodiments, the guidewire is welded to the metal part.
In some embodiments, moving or repositioning the guidewire of the obturator moves or repositions the body of the obturator. In some embodiments, moving or repositioning the guidewire of the obturator moves or repositions the body of the obturator, which in turn moves or repositions the distal tip of the catheter in which the obturator may be positioned. In some embodiments, pulling the guidewire proximally causes bending of the catheter, thereby moving the tip away from occlusions. In some embodiments, rotating the guidewire rotates the obturator, thereby rotating a distal tip of a catheter.
In some embodiments, a fluid is permitted to flow through the first and third fluid pathways. In some embodiments, a fluid is permitted to flow through the first, third and fourth fluid pathways.
In some embodiments, the obturator may one or more slits longitudinally formed through the sidewall of the tubular shaft and in proximity to the distal tip of the obturator, which may be closed. In some embodiments, the slits may have a closed configuration in which a fluid is blocked or prevented from flowing through the slits. In some embodiments, the slits may have an open configuration in which a fluid is permitted to flow through the slits. In some embodiments, the slits may be in the closed configuration when the slits are positioned within the lumen of the catheter. In some embodiments, the slits may be in the open configuration when the slits are positioned distal to the distal tip of the catheter.
In some embodiments, the open configuration of the slits may provide a fifth fluid pathway through the slits. In some embodiments, one or more strips or bands of obturator material may be interposed between the slits and outwardly biased. In some embodiments, the strips or bands of obturator material interposed between the slits may include a resilient material, such as a memory material. In some embodiments, when the slits are positioned distal to the distal tip of the catheter, the slits may open thereby collapsing the position of the distal tip in the proximal direction.
In some embodiments, the obturator may be positioned within the lumen of the catheter such that a fluid is blocked or prevented from flowing through the second, fourth, and fifth fluid pathways. In some embodiments, the obturator may be positioned within the lumen of the catheter such that a fluid is permitted to flow through the fifth fluid pathway. In some embodiments, the obturator may be positioned within the lumen of the catheter such that a fluid is permitted to flow through the second, fourth, and fifth fluid pathways.
It is to be understood that both the foregoing general description and the following detailed description are examples and explanatory and are not restrictive of the present disclosure. It should be understood that the various embodiments are not limited to the arrangements and instrumentality illustrated in the drawings. It should also be understood that the embodiments may be combined, or that other embodiments may be utilized and that structural changes, unless so claimed, may be made without departing from the scope of the various embodiments of the present disclosure. The following detailed description is, therefore, not to be taken in a limiting sense.
Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
As used in the present disclosure, 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. As used in the present disclosure, 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.
As previously mentioned, catheter functionality may be impeded for several reasons, particularly when a dwelling time of a catheter within a vasculature is prolonged. For example, the catheter may become occluded at a distal tip and its fenestrations due to the presence of fibrin sheath, thrombus, vein walls, or valves. Applying traction to move or reposition the distal tip within the vein may significantly improve blood draw success and catheter functionality by avoiding such occlusions and obstacles. Further, occlusion may be prevented by selectively opening and closing the tip of the catheter and/or one or more fenestrations. Embodiments described herein disclose a vascular access device that enables aspirations, blood draws, and/or infusions by passively repositioning the tip of the catheter and opening a fluid path and/or by selectively opening and closing at least one of the catheter tip and/or one or more fenestrations.
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In some embodiments, the obturator 50 is slidably positioned within the lumen 32 of the catheter 20 and may include a distal end 52 with an outer diameter 54 configured to form an interference fit with the inner diameter 30 of the distal tip 24 of the catheter 20. In some embodiments, the obturator 50 may include a tubular shaft 56 and a third fluid pathway 60 extending through a length of the tubular shaft 56.
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In some embodiments, the shaped portion 66 of the guidewire 64 is S-shaped. In some embodiments, the shaped portion 66 of the guidewire 64 is V-shaped. In some embodiments, the shaped portion 66 of the guidewire 64 is Z-shaped, M-shaped, N-shaped or an equivalent shape that that contacts the inner surface of the catheter lumen at two or more points. In some embodiments, the shaped portion 66 of the guidewire 64 is coiled. In some embodiments, moving or repositioning the guidewire 64 distally, proximally, and/or rotationally causes the distal tip 24 of the catheter 20 to move. In some instances, the moving or repositioning the obturator 50 causes the distal tip 24 of the catheter 20 to move away from an inner sidewall of a patient's vein 68. In some instances, moving or repositioning the obturator 50 causes the distal tip 24 of the catheter 20 to move away from an object or surface occluding the distal tip 24 of the catheter 20.
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In some embodiments, the slits 70 have a closed configuration wherein a fluid is blocked or prevented from flowing through the slits 70 and an open configuration wherein a fluid is permitted to flow through the slits 70. In some embodiments, the slits 70 is in the closed configuration when the slits 70 may be positioned within the lumen 32 of the catheter 20, as illustrated in
In some embodiments, an open configuration of the slits 70 provides a fifth fluid pathway 72 through the slits 70. In some embodiments, the strips or bands of obturator material interposed between the slits 70 is outwardly biased, such that when the slits 70 are advanced distally beyond distal tip 24, the interposed material expands outwardly, thereby opening slits 70. In some embodiments, the strips or bands of obturator material interposed between the slits 70 may include a resilient material, such as a memory material. In some embodiments, when the slits 70 may be positioned distal to the distal tip 24 of the catheter 20, the slits open thereby collapsing the position of the solid distal tip 71 in the proximal direction.
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The present application claims priority to U.S. Provisional Application Ser. No. 63/065,773, entitled “Obturator to Facilitate Catheter Line Draw”, filed Aug. 14, 2020, the entire disclosure of which is hereby incorporated by reference in its entirety.
Number | Date | Country | |
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63065773 | Aug 2020 | US |