The present application relates generally to an obturator assembly. More specifically, the present application relates to an obturator assembly having an obturator movably positioned within a catheter to selectively control a fluid flow through the catheter.
Commonly, conventional IV catheters are kept clear of clotting occlusions during their useful life by flushing the IV catheter periodically with saline or another suitable cleansing fluid or liquid. During the flushing process, the fluid is moved through the catheter to flush out any thrombus-forming clotting material contained within the catheter. Alternatively, some conventional IV catheters are kept clear of clotting occlusions by using an obturator to physically occupy a space within the IV catheter lumen. The obturator method is not universally accepted because it requires the doctor or nurse to place the obturator, which may have been recently exposed to an unsterile external environment, into the lumen of the catheter. This method may increase a risk of infection to the patient by positioning the obturator directly into the catheter such that the obturator may contact the patient's blood stream. Further, when the IV catheter is used in a therapy setting, the obturator must be removed and discard, and a replacement obturator is required.
Many conventional obturators are positioned with in the catheter in order to provide the occlusion prevention, and then removed to provide fluid aspiration and/or infusion therapy. The used obturator should be discarded after each use. This process must be repeated every time the IV catheter is accessed.
In one aspect, an obturator assembly, includes a hub forming a central passage. A catheter has a distal end and an opposing proximal end. The catheter includes a small-bore connector at the proximal end coupled to the hub. The catheter forms a lumen extending between the distal end and the proximal end of the catheter. The lumen is in fluid communication with the central passage. An obturator is movably positioned within the lumen. The obturator is movable between a first position and a second position. The obturator includes a distal end having a tip portion. With the obturator in the first position, the distal end limits fluid flow through the lumen and, with the obturator in the second position, the distal end provides a fluid flow path through the lumen.
In another aspect, an obturator is positionable within a lumen of a device and movable within the lumen between a first position and a second position. The obturator includes a distal tip portion. With the obturator in the first position, the distal tip portion limits fluid communication through the lumen of the device and, with the obturator in the second position, the distal tip portion provides fluid communication through the lumen of the device.
In yet another aspect, a method for selectably controlling a fluid flow in an obturator assembly is provided. The obturator assembly includes an obturator positioned within a lumen of a device, such as a catheter. The obturator is movable within the lumen between a first position and a second position. The method includes urging a proximal end of the obturator to move the obturator in a first direction within the lumen in one of a distal direction or a proximal direction with respect to a distal end of the catheter to provide a fluid flow path through the lumen.
Various embodiments are described below with reference to the drawings in which like elements generally are referred to by like numerals. The relationship and functioning of the various elements of the embodiments may better be understood by reference to the following detailed description. However, embodiments are not limited to those illustrated in the drawings. It should be understood that the drawings are not necessarily to scale, and in certain instances details may have been omitted that are not necessary for an understanding of embodiments disclosed herein, such as—for example—conventional fabrication and assembly.
The invention is defined by the claims, may be embodied in many different forms, and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey enabling disclosure to those skilled in the art. As used in this specification and the claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. Reference herein to any industry standards (e.g., ASTM, ANSI, IEEE, ISO standards) is defined as complying with the currently published standards as of the original filing date of this disclosure concerning the units, measurements, and testing criteria communicated by those standards unless expressly otherwise defined herein. The terms “proximal” and “distal” are used herein in the common usage sense where they refer respectively to a handle/doctor-end of a device or related object and a tool/patient-end of a device or related object. The terms “about,” “substantially,” “generally,” and other terms of degree, when used with reference to any volume, dimension, proportion, or other quantitative or qualitative value, are intended to communicate a definite and identifiable value within the standard parameters that would be understood by one of skill in the art (equivalent to a medical device engineer with experience in this field), and should be interpreted to include at least any legal equivalents, minor but functionally-insignificant variants, standard manufacturing tolerances, and including at least mathematically significant figures (although not required to be as broad as the largest range thereof).
With reference to
The example embodiments described herein provide an obturator to prevent catheter occlusion that is not required to be removed prior to therapy. Rather, the multiple state obturator can be positioned in several states. For example, in a first or closed state, the obturator is configured to close or block a lumen of the catheter to prevent occlusion and/or undesirable reverse blood flow, for example. In a second state, the obturator can be moved within the lumen in a distal direction and/or an opposite proximal direction. Further, the obturator may have a reduced outer diameter in certain embodiments such that when the obturator is advanced, the obturator provides a fluid flow path or fluid opening to allow blood return or fluid infusion. As a result, the obturator does not have to be removed from the catheter lumen; thus, reducing a risk for infection and providing a reliable occlusion prevention mechanism. In particular embodiments, the obturator is made of a suitable translucent material to act as a conduit for light-based disinfectant technology used in reducing bioburden in the intraluminal space, for example. As described herein, the example multiple state obturator is selectively controllable to prevent or allow fluid flow through the catheter without having to be removed. The obturator assembly can remain installed for the duration of the therapy and provide both an anti-occlusion mechanism and an infusion capability.
In example embodiments, an obturator assembly includes an obturator positionable within a lumen of a device, such as a catheter. The obturator is movable between a first position and a second position. The obturator has a distal tip portion, wherein, with the obturator in the first position, the distal tip portion limits fluid communication through the lumen of the device and, with the obturator in the second position, the distal tip portion provides or allows fluid communication through the lumen of the device. The obturator is configured to move automatically in a distal direction with respect to a device, e.g., the catheter, toward a second or open position in response to a pressure causing fluid to flow through the catheter lumen in the distal direction to allow the fluid to be expressed from the distal opening of the lumen. With the pressure decreased or removed, the obturator is configured to move automatically toward a first or closed position. For example, a suitable pump operatively coupled to the obturator assembly may cycle to push fluid into the proximal end of the obturator assembly. In certain embodiments, the obturator includes a spring or another suitable biasing member biasing the spring obturator toward the closed position. The obturator is configured to automatically extend from the device, e.g., the catheter, in a distal direction to allow the fluid to exit the catheter lumen at the opposing distal end of the obturator assembly. Once the fluid has passed through the lumen and the fluid pressure within the lumen is decreased, e.g., removed, the obturator is configured to move automatically toward the first or closed position to seal the distal opening of the catheter. In particular embodiments, the pump may be configured to pump some fluid then reverse its peristaltic condition when used with a movable obturator to more fully re-seat the obturator in the sealed position.
Referring now to the figures, and initially to
A catheter 22 is operatively coupled to hub 12. In example embodiments, catheter 22 has a distal end 24 and an opposing proximal end 26. Catheter 22 may include a cannula extending from a distal end 24 toward an opposing proximal end 26 of catheter 22 in certain example embodiments. At proximal end 26, catheter 22 includes an adapter or body, such as a small-bore connector 28 shown in
Referring further to
In example embodiments, with obturator 40 in the first position, distal end 42, e.g., at least a portion of tip portion 46, is positioned within lumen 30 to prevent fluid flow into lumen 30 and, with obturator 40 in the second position, distal end 42, e.g., at least a portion of tip portion 46, extends from catheter 22 in a distal direction to allow fluid flow into lumen 30. Alternatively, in certain embodiments, with obturator 40 in the second position, distal end 42, e.g., at least a portion of tip portion 46, extends into lumen 30 of catheter 22 in a proximal direction to allow fluid flow into lumen 30. In example embodiments described herein, obturator 40 is movable from the first position to the second position in a distal direction with respect to distal end 24 of catheter 22, i.e., away from hub 12, to extend beyond distal end 24 to provide a fluid flow path 54 as shown, for example, in
Referring again to
Obturator assembly 10 includes one or more seals, such as one or more sleeve seals, formed plastic seals, O-ring seals, or any suitable seals known to those having ordinary skill in the art. In certain embodiments, one or more O-ring seals 56 or other suitable seals or gaskets, are positioned about an outer periphery 58 of proximal end 44 of obturator 40 and contact an inner surface 60 of small-bore connector 28 at proximal end 26 of catheter 22. In certain embodiments, each O-ring seal 56 is positioned within a respective annular slot 62 formed in inner surface 60 of small-bore connector 28 to properly maintain O-ring seal 56 positioned about proximal end 44 of obturator 40 and between obturator 40 and catheter 22 to provide a fluid-tight seal within obturator assembly 10.
Obturator 40 has a central axis 70, shown in
In example embodiments, an amount of fluid flow (i.e., a volume of fluid) through fluid flow path 54 can be optimized by adjusting a cross-sectional area of an opening formed between an outer surface of obturator 40 and an inner wall of catheter 22 forming lumen 30. For example, an outer diameter of obturator 40 and/or an inner diameter of catheter 22 at the distal end of catheter 22 may be adjusted to reduce hemolysis and provide a desired blood sample during a blood draw application. For example, referring to
As shown in
In certain embodiments, locking collar 72 includes a tab 74 positionable within or configured to interfere with a depression 76 formed in obturator 40 with locking collar 72 in the locked configuration. Tab 74 is actuatable to allow locking collar 72 to move between the locked configuration and the unlocked configuration. For example, in example embodiments, tab 74 is depressed to allow locking collar 72 to move from the locked configuration to the unlocked configuration, which allows obturator 40 to move between the first position and the second position. In certain example embodiments, locking collar 72 is biased toward the locked configuration in one of the first position and the second position. More specifically, tab 74 may be biased, using a spring or other suitable biasing member (not shown in the figures), toward the locked configuration in one of the first position and the second position.
Referring to
A collar, such as a locking collar, is operatively coupled to the hub of the obturator assembly. In example embodiments, the method includes configuring 106 the collar in a locked configuration to prevent movement of the obturator within the lumen or in an unlocked configuration to allow movement of the obturator in the distal direction and/or the opposite proximal direction within the lumen. In the locked configuration, the collar is configured to retain the obturator in a selected position, e.g., the first position or the second position. For example, the collar can be positioned in the locked configuration to retain the obturator in the first position, e.g., a closed position preventing fluid flow through the lumen, and prevent the obturator from moving from the first position, e.g., to the second position. The collar can also be positioned in the locked configuration to retain the obturator in the second position, e.g., the open position creating a fluid flow path, and prevent the obturator from moving from the second position, e.g., to the first position. The collar can also be positioned in the unlocked configuration to allow the obturator to move with respect to the catheter in a distal direction or an opposite proximal direction. With the collar in the unlocked configuration, the obturator can be moved between the first position and the second position, for example. In certain example embodiments, the collar is biased toward the locked configuration in one of the first position and the second position. More specifically, a tab of the collar may be biased, using a spring or other suitable biasing member, toward the locked configuration in one of the first position and the second position.
Those of skill in the art will appreciate that embodiments not expressly illustrated herein may be practiced within the scope of the claims, including that features described herein for different embodiments may be combined with each other and/or with currently-known or future-developed technologies while remaining within the scope of the claims. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation unless specifically defined by context, usage, or other explicit designation. It is therefore intended that the foregoing detailed description be regarded as illustrative rather than limiting. And, it should be understood that the following claims, including all equivalents, are intended to define the spirit and scope of this invention. Furthermore, the advantages described above are not necessarily the only advantages of the invention, and it is not necessarily expected that all of the described advantages will be achieved with every embodiment. In the event of any inconsistent disclosure or definition from the present application conflicting with any document incorporated by reference, the disclosure or definition herein shall be deemed to prevail.
This application is a divisional of U.S. patent application Ser. No. 15/697,140, filed on Sep. 6, 2017, entitled OBTURATOR ASSEMBLY WITH SELECTIVELY CONTROLLABLE FLUID FLOW PATH, which is incorporated herein in its entirety.
Number | Date | Country | |
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Parent | 15697140 | Sep 2017 | US |
Child | 16918599 | US |