Patent Application
20220330858
The present invention relates to bodily fluid culture contamination reduction systems, and more particularly a system and method for reducing bodily fluid culture contamination when using a syringe for a bodily fluid draw.
Certain bodily fluids can become contaminated. For instance, a condition known as bacteraemia is the presence of microorganisms in the blood. Sepsis, on the other hand, is bacteraemia in the presence of clinical symptoms and signs such as fever, tachycardia, tachypnea and hypotension. Bacteraemia and sepsis are associated with a high mortality and an increased incidence and duration of hospital stay and associated costs. Many bacteraemias, sepsis, fungaemias (fungal contamination of a bodily fluid) and other pathogens actually originate from a hospital or other healthcare settings, with catheters and venipunctures being a major source of contamination as potential carriers of these pathogens.
Where the bodily fluid is blood, blood cultures are the standard test used to detect microbial pathogens related to bacteraemia and sepsis in a patient's blood. The term blood culture refers to a single venipuncture, either from a peripheral site or central or arterial line, with the blood inoculated into one or more blood culture bottles or containers. One bottle is considered a blood culture where two or more are considered a set. Multiple sets may be obtained from multiple venipunctures and are associated with different sites on the patient. These methods allow for microbial identification and susceptibility testing to be performed, which is a critical component to managing sepsis, however the lack of rapid results and decreased sensitivity for fastidious pathogens has led to the development of improved systems and adjunctive molecular or proteomic testing.
Collection of bodily fluid samples for conducting fluid cultures is a critical component of modern patient care and can either positively affect the patient outcome by providing an accurate diagnosis, or, by causing an infection or indicating a false positive diagnosis, can adversely affect the outcome by prolonging unnecessary antimicrobial therapy, the length of hospital stays, and increasing costs.
One outcome of collection of blood cultures is contamination. Blood culture contamination can lead to a false positive culture result and/or significant increase in healthcare related costs. Sources of blood culture contamination include improper skin antisepsis, improper collection tube disinfection, and contamination of the initial blood draw which may then skew results.
Fluid culture collection kits generally consist of a “butterfly” set, infusion set, or other type of venipuncture device, and aerobic and anaerobic blood culture bottles. Various different bottles are also available depending on the test requirements. These bottles are specifically designed to optimize recovery of both aerobic and anaerobic organisms. In conventional kits, a bottle used is known generally as a “Vacutainer,” which is a blood collection tube formed of a sterile glass or plastic tube with a closure that is evacuated to create a vacuum inside the tube to facilitate the draw of a predetermined volume of liquid such as blood.
False positive blood cultures are typically a result of poor sampling techniques. They cause the use of antibiotics when not needed, increasing hospital costs and patient anxiety. Blood cultures are drawn from a needlestick into the skin, and then a Vacutainer is attached to capture a sample of blood. Contamination may occur from improper or incomplete disinfection of the skin area in and around the puncture site. It may also occur from the coring of the skin by the needle during insertion, with the cored skin cells and any associated contamination being pulled into the sample.
Blood flow through a hypodermic needle is laminar, and as such, a velocity gradient can be developed over the flow tube as a pressure drop is applied to the hypodermic needle. Either forceful aspiration of blood, or using a very small hypodermic needle, can cause lysis and a release of potassium from the red blood cells, thereby rendering the blood samples abnormal. In other instances, some patients have delicate veins that can collapse under a pressure drop or vacuum, particularly as applied by a syringe's plunger that is drawn too quickly for the patient's condition. Since such condition is impossible to know beforehand, such vein collapses are a risk and very difficult to control. In yet other instances, a syringe is used for a blood draw if a patient's blood pressure is extremely low, as in the case of infants or neonatal patients. The syringe can be connected with the venipuncture needle via tubing and/or other fluid-conveying components.
Various strategies have been implemented to decrease culture contamination rates, e.g. training staff with regard to aseptic collection technique, feedback with regard to contamination rates and implementation of blood culture collection kits. Although skin antisepsis can reduce the burden of contamination, 20% or more of skin organisms are located deep within the dermis and are unaffected by antisepsis or other cleaning, such as swabbing by an alcohol pad. Some conventional systems and techniques for reducing blood culture contamination include discarding the initial aliquot of blood taken from central venous catheters, venipunctures, and other vascular access systems. However, these systems require the user to mechanically manipulate an intravascular device, or require a complex series of steps that are difficult to ensure being followed.
As alluded to above, in cases where a syringe is used for a blood or other fluid draw from a patient, a transfer device may be needed. The transfer device facilitates transfer from the syringe into a collection container such as a Vacutainer® bottle or other container, but only after the transfer device is disconnected from a fluid collection set. However, once a needle set or its tubing is disconnected, if the connection with the contents of the syringe are not closed, there could be inadvertent, and possibly serious, fluid leakage that could negate the effectiveness of the entire draw.
This document discloses a transfer system for a fluid collection set. The transfer system includes a syringe for drawing bodily fluids from a patient via a sealed and secured connector or proximal adapter, and a collection adapter that accepts a collection device such as a bottle or tube for transferring the drawn bodily fluids from the syringe to the collection device once the proximal adapter is disconnected. The proximal adapter and the connection between the syringe and the collection adapter is configured to remain sealed after the proximal adapter is disconnected, and until a collection device is received by the collection adapter.
In some aspects, a bodily fluid collection system for collecting a bodily fluid from a patient is disclosed. The bodily fluid collection system includes a patient needle for venipuncture of the patient to access a sample of the bodily fluid from the patient, and a fluid channel having a distal end connected with the patient needle to convey at least a sampling portion of the sample of the bodily fluid accessed from the patient. The system further includes a syringe having a barrel to contain bodily fluid, a plunger that can be activated to produce a vacuum in the barrel to draw at least some of the sampling portion of the bodily fluid into the barrel, and a hub opposite the plunger to create an inlet into the barrel. The system further includes a collection adapter having a connection port configured to securely connect with the hub of the syringe, and a collection interface opposite the connection port that creates a fluid conduit to the barrel via the connection port and the inlet of the hub. The system further includes a proximal adapter connected to the proximal end of the fluid channel, the proximal adapter being configured to removably interact with the collection interface of the collection adapter to connect the proximal end of the fluid channel to the barrel via the fluid conduit and inlet to the barrel to allow conveyance into the barrel of the at least some of the sampling portion of the sample of bodily fluid.
In other aspects, A bodily fluid transfer system for transferring a sampling portion of a bodily fluid collected by a syringe from a fluid channel, the syringe having a barrel to contain bodily fluid, a plunger that can be activated to produce a vacuum in the barrel to draw at least some of the sampling portion of the bodily fluid into the barrel, and a hub opposite the plunger to create an inlet into the barrel.
The bodily fluid transfer system includes a collection adapter having a connection port configured to securely connect with the hub of the syringe, and a collection interface opposite the connection port that creates a fluid conduit with the barrel via the connection port and the inlet of the hub. The bodily fluid transfer system further includes a proximal adapter connected to a proximal end of the fluid channel, the proximal adapter being configured to removably interact with the collection interface of the collection adapter to connect the proximal end of the fluid channel to the barrel via the fluid conduit and inlet to the barrel to allow conveyance into the barrel of the at least some of the sampling portion of the sample of bodily fluid, and upon removal of the proximal adapter from the collection interface, allow transfer of at least some of the sampling portion of the sample of the bodily fluid in the barrel to a second collector connected with the collection interface of the collection adapter.
The details of one or more embodiments are set forth in the accompanying drawings and the description below. Other features and advantages will be apparent from the description and drawings, and from the claims.
These and other aspects will now be described in detail with reference to the following drawings.
Like reference symbols in the various drawings indicate like elements.
This document describes a bodily fluid collection system 100 as illustrated in
The bodily fluid collection system 100 further includes a fluid collection device such as a syringe 108 that provides the drawing or vacuum force through the fluid optimization device 104 and to the fluid access device 102. The syringe 108 can also be part of a transfer device or system 110 that can include a collection adapter 112 connected with the syringe 108 to allow two way fluid flow therebetween based on operation of the syringe 108, and proximal adapter 114 that securely connects the set 106 to the collection adapter 112 and transfer system 110, as will be explained further below.
In some implementations, for example, a fluid sample optimization device 104 for optimizing a fluid sample collected by a fluid collection device from a fluid source, where a first portion of the fluid sample potentially likely has contaminants, includes a housing defining an inlet port, an outlet port, a contaminant containment chamber connected with the inlet port, and a sampling channel having a proximal end connected with the inlet port and a distal end connected with the outlet port. The contaminant containment chamber includes a vent configured to allow air to be displaced therein by a first portion of blood entering the inlet port and into the contaminant containment chamber such that a second portion of blood flows into the sampling channel past the contaminant containment chamber and to the outlet port. In some particular implementations, the vent can include a plug to enclose the vent to inhibit air from entering the contaminant containment chamber. In yet other implementations, the vent forms the plug to close when contacted by a bodily fluid such as blood.
The syringe 206 includes a barrel 221 to contain bodily fluid, a plunger 223 that can be activated to produce a vacuum in the barrel 221 to draw at least some of the sampling portion of the bodily fluid into the barrel 221, and a hub 225 opposite the plunger 223 to create an inlet into the barrel.
The fluid sample optimization device 204 can be connected to the patient needle by tubing, Luer connector, or the like, and the syringe 206 can be connected with the fluid sample optimization device 204 also by tubing or other fluid conveyance device.
Where the syringe 206 is used to draw fluid through the needle 202 and the fluid sample optimization device 204, it is common that the drawn fluid needs to be transferred to another collection device, such as a Vacutainer® bottle or the like. Accordingly, the bodily fluid collection system 200 includes a transfer system 208 that includes the syringe 206 and a collection adapter 210 attached to the opening of the syringe. The collection adapter 210 connects to the syringe by a connection port, such as a Luer connector, and includes a housing and an opening opposite the connection port that is sized and adapted for receiving a collection bottle or tube, such as an evacuated bottle. In some implementations, the collection adapter further includes a collection needle, initially connected with fluid sample optimization device 204 via proximal tubing or other fluid conduit and a proximal adapter 212, and through which at least some of the subsequent portions of fluid drawn by the syringe 206 are conveyed to the syringe 206. The proximal adapter 212 can be part of the set 201 as the proximal end of tubing connected with the fluid sample optimization device 204.
The proximal adapter 212 can be a self sealing membrane or pre slit membrane and may include a Luer connection, a snap arm, twist, friction fit, or other securement device for securely attaching the set 201 to the transfer system 208, via the collection adapter. The proximal adapter 212 seals to the transfer system 208 to allow fluid to flow into the transfer system 208 and to the syringe 206.
Importantly, the set 201 needs a way or mechanism to seal once it is disconnected from the transfer system 208 to prevent any residual fluid in the set 201 from leaking out. In some implementations, the proximal adapter 212 has a self-sealing access port, such as a pierceable septum, for covering the collection needle in the collection adapter 210, whether or not the collection needle is sealed with a boot or other cover. In other implementations, a separate side clamp, pinch clamp, or on/off valve on or connected with the tubing can be provided for the user to actuate prior to disconnecting the set 201 from the transfer system 208, as described in further detail below.
In some implementations, turning the proximal adapter to connect and lock it to the collection adapter can actuate the opening of the fluid conduit through the proximal adapter, while turning the proximal adapter in a reverse direction to disconnect it from the collection adapter can actuate the closing or sealing of the fluid conduit. In these implementations, an external clamp or valve or other closure device is not needed.
However, instead of having a booted needle, the transfer system can have an external valve 902 to open and close flow between the syringe and the collection adapter, as shown in
In some implementations consistent with the subject matter described herein, a bodily fluid collection system, as described herein, can be used in the following manner. The user inserts the patient needle into the patient for blood collection. The insertion is part of a venipuncture that can occur in the patient's arm, or on another part of the patient's body. Once the fluid sample optimization device is primed, i.e. the first portion of the drawn sample is sidelined and at least temporarily contained in a contaminant containment chamber, the practitioner can draw subsequent portions of fluid samples by pulling back on the syringe plunger. Once the desired volume of fluid has been drawn and collected into the syringe, the patient needle is removed from the patient.
Next, the fluid collection set is removed from the transfer system that includes the syringe. The practitioner can then attach a collection bottle or tube to the collection adapter, to transfer fluid drawn into the syringe to one or more collection bottles or tubes, where a vacuum inside the bottle or tube pulls the appropriate volume into the collection bottle or tube.
In some implementations, as shown in
Although a few embodiments have been described in detail above, other modifications are possible. Other embodiments may be within the scope of the following claims.
| Number | Date | Country | |
|---|---|---|---|
| 63161906 | Mar 2021 | US |
