The present embodiments relate generally to medical devices, and more particularly, to medical devices for drainage.
The accumulation of air or fluid in the pleural space can prevent the lung(s) from expanding fully during breathing. In some cases, this is life-threatening. Current British Thoracic Society guidelines recommend that initial treatment of pleural disease typically involves the placement of a drainage catheter in order to drain the air and/or excess fluid. Pleural drainage devices require secure and airtight connections to suction devices in order to effectively drain the pleural space. Current pleural drainage product offerings typically have hubs with a conical shape or a luer-lock fitting. These options generally require the use of adapters to connect the drainage catheters to suction equipment that is necessary for drainage. Current product offerings rely on a friction fit between the catheter hub (or adapter) and the suction device. Tape is also widely used for improved securement.
Various styles of stopcocks are commonly used with a syringe to sample fluid from the pleural space, which is necessary for diagnostic workup. The stopcock+syringe is also used to flush the drain or to instill therapeutic fluids as a treatment option. However, commercially available stopcock options have more restrictive internal diameters than all large-bore drains and some small-bore drains.
One general aspect of the present disclosure includes a drainage system, including: a clip including a first grip and a second grip; and a stopcock, which includes: a base, and a first barbed adapter extending from the base, the first barbed adapter including a first shaft portion and a first barbed portion, where the first grip is configured to fit over a first tubing coupled to the first barbed portion, and the second grip is configured to fit over the first shaft portion, such that the first tubing is secured to the stopcock via the clip.
Another general aspect of the present disclosure includes a drainage system, including: a clip including a first grip and a second grip; and a stopcock, which includes: a base, a first barbed adapter extending from the base, the first barbed adapter including a first shaft portion and a first barbed portion, and a second barbed adapter extending from the base, the second barbed adapter including a second shaft portion and a second barbed portion, where the first grip is configured to fit over a first tubing coupled to the first barbed portion, and the second grip is configured to fit over a second tubing coupled to the second barbed portion, such that the first tubing and the second tubing are secured to the stopcock via the clip.
Another general aspect of the present disclosure includes a stopcock, including: a base; a first barbed adapter extending from the base; a second barbed adapter extending from the base, where the first barbed adapter and the second barbed adapter are substantially 180 degrees apart; and a connection port extending from the base, where the connection port is substantially 90 degrees apart from the first barbed adapter and the second barbed adapter.
Another general aspect of the present disclosure includes a clip, including: a first grip including a first arm and a second arm; and a second grip including a third arm and a fourth arm, where the first arm and the second arm are spaced apart a first distance, the first distance being dimensioned such that the first grip fits snugly over a first medical tubing, where the third arm and the fourth arm are spaced apart a second distance, the second distance being dimensioned such that the second grip fits snugly over a second medical tubing, and where the first distance is greater than the second distance.
Another general aspect of the present disclosure includes a clip, including: a first grip including a first arm and a second arm; and a second grip including a third arm and a fourth arm, where the first arm and the third arm are connected via a first bar, where the second arm and the fourth arm are connected via a second bar, and where the second bar includes a bend.
Other systems, methods, features and advantages of the invention will be, or will become, apparent to one with skill in the art upon examination of the following figures and detailed description. It is intended that all such additional systems, methods, features and advantages be within the scope of the invention.
The invention can be better understood with reference to the following drawings and description. The components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention. Moreover, in the figures, like referenced numerals designate corresponding parts throughout the different views.
Various aspects are described below with reference to the drawings in which like elements generally are identified by like numerals. The relationship and functioning of the various elements of the aspects may better be understood by reference to the following detailed description. However, aspects are not limited to those illustrated in the drawings or explicitly described below. It also should be understood that the drawings are not necessarily to scale (although certain drawings may be drawn to scale and relied upon as such), and in certain instances details may have been omitted that are not necessary for an understanding of aspects disclosed herein, such as conventional material, construction, and assembly.
For purposes of promoting an understanding of the presently disclosed embodiments, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. It should nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated device, and such further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates.
In the present application, the term “configured to” is used to describe structural limitations in a particular manner that requires specific construction to accomplish a stated function and/or to interface or interact with another component(s), and is not used to describe mere intended or theoretical uses. Relative terminology and broader terms such as “generally,” “about,” “substantially,” and the like will be understood by those of skill in the art as providing clear and definite scope of disclosure and/or claiming. For example, the term “substantially 180 degrees apart” will be understood as not requiring exactly 180 degrees apart, but rather including that and functional equivalents.
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The stopcock 12 also includes a plug 30 rotatably disposed in the base 14 and configured to provide directional flow through the stopcock 12. In some embodiments, as shown in
Moreover, ribbed or “coin edge” grip on the plug 30 allows for easy actuation while wearing medical gloves. The orientation of the barbed fittings/adapters of this stopcock, as compared to commercial 2-way and 3-way luer stopcocks, allows for an ergonomic hand hold during valve actuation, providing a more comfortable grip and stability during twisting of the valve mechanism (e.g., the plug 30) instead of relying on gripping attached tubes.
In some embodiments, the plug 30 may have rounded edges and a reduced profile to minimize discomfort to a patient. In some embodiments, the plug 30 and the base 14 may include corresponding detents for locking them together and/or preventing accidental rotation of the plug 30. Providing a physical hard-stop between the plug 30 and the base 14 of the stopcock prevents inadvertent over-rotation (e.g., preventing rotation of the plug more than 270 degrees) and minimizes the likelihood of use error that could result in patient harm. In some embodiments, the plug 30 and the base 14 may be mated with a semi-circular ridge, so that they can be easily paired during the manufacturing process.
In some embodiments, the stopcock 12 may be configured to have an inner diameter 32 (e.g., as shown in
The ID (“inner diameter”) of commercially available stopcocks is smaller than the OD (“outer diameter”) of inserters (e.g., stiffeners, obturators, trocars, bougies) which are used to aid in the insertion of 14 Fr and larger chest drains (e.g., Seldinger technique or trocar technique). When clinicians desire high flow from a chest drain, they often select a large bore tube. Commercially available stopcocks create a bottleneck in the system when connected to any large bore drain. Imposing a bottleneck in flow negates the benefit of using a drain with a large inner diameter, effectively reducing the flow to the ID of the stopcock instead of the drain ID. The stopcock 12 in this application will reduce the likelihood of a bottleneck for large bore drains up to 24 or 32 Fr. For example, when a drainage catheter having an outer diameter equal to or larger than 16 Fr is connected to the stopcock 12, a flow through the drainage catheter is not reduced to an inner diameter of the stopcock 12.
The disclosed stopcock 12 with 180 degree orientation between barbed fittings/adapters provides a straight and consistent ID from end-to-end, minimizing the likelihood that debris from pleural fluid (e.g., fibrin strands, pus, chyle, thrombi) may become stuck or entrapped, as may be expected with an ID reduction or change in flow direction. 180 degree opposed barbed fittings/adapters with wide bore allow for unimpeded passage of air or fluid, as well as associated tools and instruments such as dilators, obturators, guide wires, rigid or flexible scopes, viscous materials, medical or therapeutic agents.
The outer diameters of the barbed fittings/adapters are selected for compatibility with a variety of tubing commonly connected to chest drains, including tubing that comes with commercially available vacuum pumps, water seals, and dry seals. Such tubing may be silicone, vinyl, or other materials that are more compliant or more rigid. The configuration of the barbed fittings/adapters (e.g., diameters and tapers) are designed to securely contact the ID of any tubing mated to them. This improves sealing and minimizes the need for taping connections. The distance or length of the barbed fittings/adapters is shortened compared to common “Christmas tree” or 5-in-1 connectors. This reduces the overall bulk of the stopcock for benefit to patient comfort. Patients with chest drains are commonly inpatient and in a bed. Larger connections on chest drains are more likely to produce discomfort or injury to the patient if (or when) the patient accidentally lays on the device.
As discussed in greater detail below, in some embodiments, the stopcock 12 may be the only necessary connection between the drain and vacuum unit. The use of a stopcock eliminates the need for multiple adapters and connectors for basic drainage and therapeutic fluid instillation functions or diagnostic sampling. The configuration of the stopcock 12 eliminates the need to connect more than one adapter for draining, sampling fluids, instilling therapeutic fluids, and venting a pneumothorax. The stopcock 12 allows for the drain (e.g., chest drain) and the vacuum tubing to connect at a single hub without sacrificing any functionality of current sets and trays. The reduced quantity of parts in the connection setup reduces the likelihood that components would contact surfaces outside the sterile field. The stopcock is also advantageous for controlling flow or air release after drain placement. To improve the securement of tubing on the barbed adapters of the stopcock 12, the stopcock 12 may be configured to be compatible with clips or other securement devices to limit heavy taping around the drain and simplify maintenance.
The perpendicular connection port 20 (e.g., luer sideport) can allow for instillation of a therapeutic agent or insertion of a pressure monitor, or evacuation or sampling of fluid/air. A standard luer closure may also be attached to maintain hygiene and prevent accidental opening (and patient harm). A luer fitting must necessarily meet industry standards for luer connections, which define ID dimensions and taper characteristics—essentially mandating a bottleneck compared to the ID of any large bore chest drain. Therefore, it is ideal to place the connection port 20 perpendicular to the high-flow pathway between the 180-degree-apart barbed fittings/adapters.
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In some embodiments, as shown in
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The first grip 33 and the second grip 35 may be configured such that the first distance 44 and the second distance 46 may be varied during use (e.g., the grips are made of a flexible material) to accommodate the tubing and stopcock with different sizes. In some embodiments, the first distance 44 may be in the range of about 11 mm-13 mm, for example, the first distance 44 may be about 12 mm. In some embodiments, the second distance 46 may be in the range of about 6.5 mm-8.0 mm, for example, the second distance 46 may be about 7.25 mm.
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The configuration of the first clip 34 and the first embodiment of the drainage system 10 including a stopcock 12 and two first clips 34a and 34b is advantageous for assisting users with versatility and efficient securement throughout drain care. For example, if a patient needs to be transported, the first tubing 48 (e.g., vacuum tubing) can be easily disconnected without disruption to the connection between the second tubing 48′ (e.g., drainage tubing) and the stopcock 12. In addition, the first clip 34 provides users with a cleaner workspace by limiting the use of tape during drain observation and maintenance.
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In some embodiments, the second clip 56 may also include a support bar 78 extending between the first grip 55 and the second grip 57. As shown in
In some embodiments, as shown in
The first grip 55 and the second grip 57 may be configured such that the first distance 70 and the second distance 72 may be varied during use (e.g., the grips are made of a flexible material) to accommodate tubing and stopcock with different sizes. In some embodiments, the first distance 70 and the second distance 72 may be the same, and in the range of about 10.5 mm-12.0 mm.
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The configuration of the second clip 56 is advantageous for providing simplified securement of tubing connections on both ends of the barbed stopcock 12 without the need of using multiple smaller clips. In some embodiments, the first clip 34 and the second clip 56 may each include a tether attachment. The tether may connect on both the clip and the stopcock so that if the clip was taken off the stopcock it would not fall far from the assembly. In other words, even if some parts drop, it would not break the sterility of the part. Adding the clip tether to the larger assembly would also mitigate dropping of the clips after drain placement. The first clip 34 and the second clip 56 each may be made of a soft (yet not pliable) material, without sharp edges or hard materials that cause discomfort and/or harm the patient when they are rolled onto. A variety of softer plastic materials may be considered for the clips to ensure patient comfortability throughout placement. In some embodiments, the first clip 34 and the second clip 56 each may include flat side surfaces, which is advantageous for preventing assembly shifting or disconnection.
While various embodiments of the invention have been described, the invention is not to be restricted except in light of the attached claims and their equivalents. Moreover, the advantages described herein are not necessarily the only advantages of the invention and it is not necessarily expected that every embodiment of the invention will achieve all of the advantages described.
This application claims priority from U.S. Provisional Application No. 63/433,841, filed Dec. 20, 2022, which is hereby fully incorporated by reference herein in its entirety.
Number | Date | Country | |
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63433841 | Dec 2022 | US |