The present application claims priority to provisional application Ser. No. 62/988,257, and filed on Mar. 11, 2020, which is hereby incorporated by reference for all that it discloses or teaches.
When drawing blood, a phlebotomist typically uses a blood collection apparatus that includes a needle and a blood collection vial connected to the needle via a first length of tubing. The blood collection apparatus is typically coupled to a waste tube by another length of tubing. The waste tube receives waste that is expelled from the blood collection apparatus as the blood accumulates in the blood collection vial. For example, the waste may include a saline solution and/or air that is initially in the blood collection vial prior to the blood draw. As this waste is displaced by blood, the waste is drawn into waste tube which remains vacuum-sealed throughout the blood draw. Use of the waste tube ensures that the blood collection vial remains free of any potential contaminants. When used correctly, a waste tube may be sterilized post-use and recycled for future use.
In some cases, a hub is used to help attach the waste tube to tubing that extends from the needle to the blood collection vial. The hub may, for example, include a casing that the waste tube rests within to keep the waste tube properly positioned during the blood draw. The casing typically includes a needle that provides a channel into the waste tube when the waste tube is correctly inserted in the hub. This configuration allows for vacuum-sealed transmission of fluids between the blood collection apparatus and the waste tube.
While industry standard, the above-described configuration presents some challenges. Typically, a phlebotomist attaches the waste tube to the hub after inserting the blood draw needle into a vein. Thus, the phlebotomist uses one hand to hold the needle in place within the vein and has only one free hand to insert the waste tube into the hub. If the waste tube is inserted at an angle such that there exists a slight misalignment between an aperture in a rubber tip of the waste tube and the first end of the needle, the needle may puncture the glass side of the waste tube, breaking it and rendering it unusable. In current applications, the waste tube failure rate of this operation is as high as 25-30%. The need to replace rather than reuse nearly ⅓ of all waste tubes directly impacts supply costs for medical facilities. Moreover, since it is relatively easy to accidently break the waste tube, phlebotomists may take extra care during blood draw procedures to correctly attach the waste tube to the hub. This increases the total time of each blood draw operation, reducing overall efficiency. In clinic trials, phlebotomists may be critiqued on their ability to meet per-sample time goals (e.g., collect a number of samples in a set period of time). The high waste tube failure rate and reduced efficiency associated with current designs frustrate these goals.
According to one implementation, a cartridge for securing a waste tube during a phlebotomy operation has a T-shaped body that includes a tubular central portion and one or more gripping flanges. The tubular central portion has an open first end and an elongated cavity, the elongated cavity being sized and shaped to receive the waste tube through the open first end. The one or more gripping flanges are attached to a second end of the tubular central portion that is opposite the first end and positioned to extend from the tubular central portion in a plane substantially perpendicular to elongated cavity. The cartridge further includes a plunger mechanism affixed to the T-shaped body that includes a stem adapted to slide into the elongated cavity through the second end of tubular central portion responsive to an applied external force to eject the waste tube from the elongated cavity through the open first end of the cavity.
This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. Other implementations are also described and recited herein.
The technology disclosed herein includes a cartridge that is used to secure a waste tube within a hub during a blood draw. Features of the cartridge simplify coupling of the waste tube and the hub so as to reduce waste tube failure rates, extending the effective lifetime of each waste tube and thereby reducing total supply costs.
By example and without limitation, the waste tube 106 is shown to include a rubber stopper 110 that is designed to mate with a portion of the hub needle 102 internal to the hub 104. For example, the portion of the hub needle 102 internal to the hub 104 may include a rubber sleeve 114 that is adapted for insertion into a tiny aperture in the rubber stopper 110, such that the rubber sleeve 114 may form an air tight seal against the rubber stopper 110 while allowing fluid to flow up through the needle 102 and into the waste tube 106.
In traditional phlebotomy operations, it can be difficult to properly position the waste tube 106 within the hub 104, particularly if the user has only one free hand (e.g., because the other hand is used to apply pressure to a needle within a vein). If the waste tube 106 is inserted into the hub 104 at a slight angle, the portion of the needle that is internal to the hub 104 may strike and break the glass of the waste tube 106.
In the system of
In one implementation, the cartridge 116 is designed to remain external to the waste tube 106 and is therefore completely isolated from the fluid channel that draws liquid waste air up the hub needle 102 and into the waste tube 106 such that there is no risk that the cartridge 116 may come into contact with fluids that are flowed into and stored within the waste tube 106. Thus, the cartridge 116 can be readily reused without a need for sterilization between uses.
Although the cartridge 116 may have different features in different implementations, the cartridge 116 of
In addition to the tubular central portion 124, the cartridge 116 further includes gripping flanges 126 and 128 that extend in a direction substantially perpendicular to a primary axis of the tubular central portion 124. As used herein, “substantially perpendicular” shall refer to an angle that is within +/−5% of true perpendicular.
In addition to the features discussed above, the cartridge 116 further includes a plunger mechanism 118 affixed to the T-shaped body 120. The plunger mechanism 118 includes a stem 130 that is adapted to slide in and out of the cavity in the tubular central portion 124 responsive to an external force applied to push the stem 130 toward the cavity. The plunger mechanism 118 is shown to be spring-loaded such that a majority of the stem 130 is external to the cavity in the absence of applied force. When the user applies a force to the plunger mechanism 118, the spring collapses and allows the stem 130 to contact and dislodge the waste tube 106 within the cavity, pushing the waste tube 106 out through the open end 122. For example, the user uses an index and middle finger on one hand to pull the gripping flanges 126, 128 in a first direction while using his/her thumb to force the stem 130 of the plunger mechanism 118 into the cavity, thereby forcibly ejecting the waste tube 106 out through the open end 122. By engaging the plunger mechanism 118 in this way, the waste tube 106 may be selectively dislodged and pushed out of the cartridge without requiring the user to physically touch the waste tube 106.
Since the cartridge 216 prevents the needle in the hub 204 from striking the waste tube 206 at an angle (which could potentially shatter the glass tube), use of the cartridge 216 decreases the failure rate of the waste tube 206. Moreover, the cartridge 216 is easy to grip with one hand, thereby improving the ease of connecting the waste tube 206 to the hub 204 and improving the speed of such process.
Although not shown in
The tubular central portion 308 includes one or apertures proximal to the second end 324 (e.g., an aperture 326) that function to expel air from the central elongated cavity that is displaced by the waste tube 304 when the waste tube 304 is inserted. In the illustrated design, two apertures are include on opposite sides of the tubular central portion 308 such that it is possible to see straight through the cartridge 302 when the waste tube is not inserted. Other implementations may have one or more differently shaped or placed apertures that provide the same or similar functionality.
A plunger mechanism 318 is affixed to the T-shaped body 320 and includes a stem 322 adapted to slide into the central elongated cavity through a second end 324 of tubular central portion 308 responsive to an applied external force that compresses a spring 328. For example, a user may place a thumb on the end of the plunger mechanism 318 while wrapping his/her index finger and middle finger of the same hand around flanges 312 and 314. While in this position, the user pushes the thumb toward the index and middle fingers (in the direction of arrow “A”) to compress a spring 328 and slide the stem 322 into the central elongated cavity of the tubular central portion 308, which forcibly ejects the waste tube 304 from the first end 310 of the central elongated cavity.
According to one implementation, waste tube 402 can be easily inserted into the cartridge 400 (e.g., via single push of the waste tube 402 into the cartridge cavity) and touchlessly expelled from the cartridge 400, such as to drop the waste tube 402 into a biohazard collection box. Since the cartridge 400 remains entirely external to the waste tube, there is no potential for contamination of the cartridge 400 with the waste fluid that is collected within the waste tube 402 during a blood draw procedure. This ensures that the cartridge can be recycled without a need for extra sanitation operations. In some implementations, the stem 434 is not spring-loaded as described and shown in
In some implementations, the cartridge 500 may be made of a more flexible material than the waste tube such that the user force applied to the waste tube causes the sidewalls of the elongated cavity 512 to flex away from the cartridge 500, allowing the cartridge 500 to slide past the inwardly-protruding features 510. Effectively, the textured ribs 510 lock the waste tube into place within the cavity 512 such that the waste tube may not be easily dislodged (e.g., fall out of) the elongated cavity 512 absent a user-applied ejection force.
The tubular central portion has a first end coupled to a flange piece 506 which forms a top of the “T” in the T-shaped central body 502. As shown in view B, the flange piece 506 has an aperture 514 through which a stem 508 may be threadedly inserted in the direction indicated by arrows in
The flange piece 506 and provides gripping surfaces around which a user may wrap two fingers (e.g., index and middle finger) while positioning the thumb on a plunger mechanism, which may have characteristics the same or similar to the plunger mechanism 318 shown and described with respect to
The tubular central portion 602 further provides one or more through-holes 616 that provide a channel between the elongated cavity 604 and an environment external to the tubular central portion 602. In at least one implementation, the waste tube is designed to be just slightly smaller than the largest diameter of the elongated cavity 604 such air displaced cannot readily flow through the interface between the waste tube and the sidewall of the elongated cavity 604. Rather, the insertion of the waste tube into the elongated cavity 604 forces air out through the one or more through-holes 616. In one implementation, the diameter of the elongated cavity 604 is approximately 11.1 mm and the corresponding diameter of the waste tube is approximately 10.25 mm. Thus, the waste tube fits snugly within the elongated cavity 604. The waste tube may include internally-protruding features, such as textured ribs or teeth (as described elsewhere herein) to provide friction that effectively locks the waste tube into place. These features may locally reduce the internal diameter of the internal cavity to approximately match or to be less than the diameter of the waste tube.
In addition to those features discussed above, the tubular central portion 602 also includes a stem-guiding portion 618 for receiving and guiding a stem (such as the stem 508 in
In addition to those features discussed above and with respect to
The above specification, examples, and data provide a complete description of the structure and use of exemplary embodiments of the invention. Since many implementations of the invention can be made without departing from the spirit and scope of the invention, the invention resides in the claims hereinafter appended. Furthermore, structural features of the different embodiments may be combined in yet another implementation without departing from the recited claims.
Number | Date | Country | |
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62988257 | Mar 2020 | US |