System and Method for Sampling Device for Bodily Fluids
There is provided a device for sampling bodily fluids. Some embodiments have a handle, a lumen, and a diverter valve. The distal end of the handle is adapted to connect with a sampling device and is in fluid communication with the lumen. There is a vacuum connection on the proximal end of the handle that is also in fluid communication with the lumen. A suction valve may desirably be located in the lumen to control the application of vacuum from the vacuum connection to the sampling device. The diverter valve directs the flow through the lumen such that a sample from the patient goes into a sputum trap when the trap is connected. The device may further have a saline port in fluid communication with the lumen, located distal to the suction valve, for rinsing the tube and diluting secretions.
This application claims the benefit of U.S. provisional patent application 61/444,451 filed Feb. 18, 2011 and U.S. provisional patent application 61/393,482 filed Oct. 15, 2010.
The present disclosure relates generally to the field of medicine and more particularly relates to obtaining a sample in an integrated system and identifying the bacterial load in that sample specifically in sputum.
When a patient is admitted to a hospital, or a specific unit of the hospital, e.g.; the ICU (intensive care unit), they are often tested for the presence of infection causing microorganisms in their system through blood, urine, skin, and sputum. Depending on hospital protocol this screening test is completed upon admission to the various areas of the hospital or upon clinical signs of infection including fever, increased white blood cell count, discolored sputum, purulent sputum, decreased oxygenation, hazy chest X-ray, etc.
Currently, the sputum samples are obtained via bronchoscopy, non-bronchoscopic broncheoaviolar lavage (BAL), closed suction catheter, open suction catheter, or expectorated sample. The sample is then retained in a separate sputum trap container that is connected to the sampling device through flexible tubing connections or other means (
The sample in the sputum trap is transported to the clinical microbiology laboratory for microbial testing and analysis. The sputum trap is commonly transported in a pneumatic system from the ICU to the lab. A problem that sometimes arises is that the sample can spill or leak in the pneumatic tubing as it is being transported. This can contaminate the pneumatic system, putting the integrity of other samples transported at risk and requiring a re-sampling of the patient, with its concomitant risks.
While the clinician is waiting for the microbial data to return and the patient is showing clinical signs of infection, common practice is to give the patient 3-5 broad spectrum antibiotics to cover all possible organisms that could be the causing the infection. These antibiotics have toxic side effects to the patient. For example, some antibiotics can cause harm to the function of the kidneys. Overuse of unnecessary antibiotics can cause super bugs and antibiotic resistance, which is a well published universal problem in health care. The use of these potentially unnecessary antibiotics also incurs a large cost to the hospital. The clinician may also isolate a patient that is suspected of having a resistant or highly contagious organism (e.g.; MRSA or TB). There is, of course, an associated cost to so isolate a patient suspected of carrying a concerning organisms.
The first round of microbial data that a physician receives is called a gram stain. A gram stain identifies if a bacterial organism is in either the gram negative or gram positive class and the morphology of the bacteria (i.e. cocci, rod, etc . . . ). This allows the clinician to remove antibiotic(s) that affect the class of organisms with which the patient is not infected. A gram stain test takes approximately 1 hour to perform, but with transportation time of the sample and the typical lab testing back-log, our results show that most ICU clinicians receive the gram stain results in 12-24 hours. During this time a patient is placed on the 3-5 broad spectrum antibiotics mentioned above until the clinician reviews the gram stain results and removes 1-3 unnecessary broad spectrum antibiotics.
Many studies have tested the specificity and sensitivity of the standard gram stain and the general consensus is that the gram stain in about 80% sensitive and 80% specific. The gram stain is a subjective test because the lab technician is viewing the sample under a microscope to identify the color and location of a staining dye in bacteria cells and tests results could be gram variable, meaning the technician could not identify the bacterial gram class. There are also several steps to complete a gram stain that include chemical washings and dyes that are user dependent. If these steps are not followed well, the test could be less accurate. The gram stain procedure generally includes the followings steps: 1) place a slide with a bacterial smear on a staining rack, 2) stain the slide with crystal violet for 1-2 minutes, 3) pour off the stain, 4) flood slide with Gram's iodine for 1-2 min., 5) pour off the iodine, 6) decolorize by washing the slide briefly with acetone (2-3 seconds), 7) wash slide thoroughly with water to remove the acetone—do not delay with this step, 8) flood slide with safranin counter stain for 2 min., 9) wash with water, 10) blot excess water and dry by hand over (Bunsen) flame.
The second round of microbial data that a physician receives is called a microbial specificity. These results are obtained in 24-48 hours and require culturing of the organisms on an agar plate. Microbial specificity identifies the exact organism(s) that are causing the infection and the concentration of that organism(s) in a quantitative or semi-quantitative fashion. These results allow the clinician to change the broad spectrum antibiotics to antibiotics targeted for the specific organism that is causing the infection. The clinician may also wait to change antibiotics if the patient is improving or until further results are obtained.
The third round of microbial data that a physician received is call antibiotic sensitivities. These results are obtained in 48-72 hours and require testing the cultured sample against known antibiotics to determine the resistance pattern of the organism. Once it is know what antibiotics the organism is sensitive to or will kill the organism(s), the clinician can change to one targeted antibiotic to cure the infection.
Thus, there remains a need in the art for a sampling system that is easy to use and maintains the integrity of the sample, both during sampling and transportation, and that reduces the likelihood that medical personnel with come in contact with the sample. This will improve the quality of the sample and reduce the need for re-sampling of the patient, saving the patient from repeated physical intrusion, saving time in beginning proper treatment and saving money currently used on inappropriate medication.SUMMARY
In response to the difficulties and problems discussed herein, the present disclosure provides a sampling device for the collection of secretions from a patient. According to the disclosure, a sputum sample is obtained from the patient, desirably below the corina and ideally in the third generation lung lobe. This sample is retained in the sputum trap for transportation to a lab for analysis.
The sampling is done in such a way as to minimize the possibility of exposure of the medical personnel to microbes and to reduce the likelihood of spills and leakage of the sample. As noted below, the system described herein is closed and provides protection for the sample and the medical personnel. The unique valving and optional loss prevention media help to keep the system closed even if the sample container is inverted or tipped over accidentally during the sampling procedure.
By providing a reliable sample, this rapid system for microbial identification should allow the clinician to prescribe fewer and perhaps less initial antibiotics to the patient, thus saving toxicity to the patient, decreasing antibiotic resistance, and saving the hospital costs on unnecessary antibiotics.
In one embodiment, there is a device for sampling bodily fluids using a handle having a lumen. The distal end of the handle is adapted to connect to a sampling device which is in fluid communication with the lumen in the handle. There is also a vacuum connection on the proximal end of the handle which is also in fluid communication with the lumen in the handle. A diverter valve is located in the lumen in the handle and is used to direct a sample from a patient into a sputum trap.
In some embodiments, the sample is directed from the patient into the sputum trap by connecting the trap to the diverter valve body. In these embodiments, the flow of fluid occurs from the distal end of the device to the suction source when the trap is not attached. When the trap is attached to the valve body, the flow is diverted into the trap so that the sample may be captured. In some embodiments the trap is attached to the valve body by pushing it upwardly onto the valve body. In other embodiments the trap is attached to the valve body by inserting the valve body into the top of the trap and turning the valve body relative to the trap. Other attachment connections between the trap and the valve body involve combinations of pushing, inserting, and/or turning these respective parts.
There may be a saline port present in some embodiments to allow saline solution to be injected into the lungs of the patient to loosen and reduce the viscosity of secretions to be sampled.
A loss- or spill-prevention media may be included in the sputum trap to minimize the chance that a sample will exit the trap should the trap be inadvertently overturned. In addition, a slit, dome or other type of self-sealing valve may be used in the top of the sputum trap to help minimize the chance that a sample will spill from the trap.
It should be noted that the terms “distal” and “proximal” are used in their common medical usage throughout; distal being on the side closer to a patient and proximal being on the side farther away from the patient. Using this terminology, the side of a device closed to a patient is the distal side and the side farther away is the proximal side.
The saline port, if present, is in fluid communication with the lumen 24. Saline solution can be injected into the saline port 26 to rinse the tubing 22 and distal device and to rinse or dilute secretions within the patient's body to make them less viscous and easier to remove. The saline port 26 can accept a tapered luer, luer lock syringe, or a standard saline bullet. The saline port 26 desirably includes a valve, desirably a one way check valve (not shown) to close the port when a syringe is not connected in order to prevent contaminates from entering or escaping. Inserting a saline bullet opens the check valve and allows saline solution to flow into the lavage/suction lumen 24 of the handle 20. The saline port 26 is in direct communication with the handle's lavage/suction lumen 24. When the saline bullet is removed, the check valve closes, thus maintaining the integrity of the closed system.
The handle 20 desirably incorporates a finger suction control valve 28 for regulating vacuum to the distal end of the device and/or catheter. Alternatively, suction control can be incorporated into a distal device, e.g. a bronchoscope, so that a suction control valve is not needed on the handle. The valve 28 is in the normally closed position (no flow through the lumen 24) and is activated, i.e. opened for fluid flow through the lumen, upon the application of finger-induced pressure to depress the valve body 25 into the handle. Depressing the valve body 25 aligns a hole or passageway in the valve body 25 with the lumen 24, thereby allowing fluid flow through the lumen 24 and valve 28. The valve 28 automatically returns to the closed position after the user removes his finger from the valve 28, desirably by the action of a spring, though other suitable mechanisms may be used. This valve 28 could make use of a number of known mechanism designs including trumpet valves, Ballard TrachCare® thumb valves, Ballard ReadyCare® valves, etc. In this embodiment (
The handle 20 also incorporates a male vacuum port 30 to which standard vacuum tubing used in the typical hospital can attach. The vacuum port 30 is in communication with the lumen 24. The handle 20 is designed to be used with a continuous vacuum sources supplied by the hospital or by portable vacuum units.
The handle 20 also has a sputum trap port 32 where a sputum trap 40 (
The handle 20 functions with or without a sputum trap 40 attached. The handle 20 in this embodiment incorporates a diverter valve 36 within the handle 20 which allows flow from the patient either directly towards the vacuum port 30 or into the sputum trap 40 when the trap 40 is attached. When the sputum trap 40 is not attached, the diverter valve 36 does not block the lumen 24 because valve 36 is pushed out of the way by a spring 38 or other mechanism like a coil, leaf, or elastic material etc. (
The sputum trap 40 is spill resistant when it is not connected to the sputum trap port 32 via a self-sealing valve 46 incorporated into the sputum trap cap 44. Such spill resistant means could be a slit-type or “slit” valve 46 as shown in
Another type of spill resistant means that could be used is shown in
The entire sputum trap cap 44 may be removed in a manner similar to prior art sputum traps. This allows lab techs to easily access the sample within according to known procedures. A secondary cap 42 can be attached to the sputum trap cap 44 for use for long term storage or shipping/handling to the lab for extra security and confidence. The secondary cap 42 desirably fits into the cap 44 where the handle sputum trap port 32 has been removed.
Another embodiment (
When a sputum trap 40 is attached to the handle 20 of the embodiment of
In still another embodiment,
As shown in
It should be clear that some of the embodiments contain a valve having a first position in which a distal end of the valve is in fluid communication with a source of vacuum and a second position in which the distal end of the valve is in fluid communication with a sputum trap and the sputum trap is in fluid communication with the source of vacuum. The diverter valve in these embodiments may be moved from the first position to the second position by the connection of the sputum trap to the valve body
In the use of the disclosed device, once the sampling tube 22 (or its associated distal device as discussed above) is inserted into the desired location (desirably below the corina, ideally in the third generation lung lobe), saline solution may be injected via the saline port 26 and allowed to travel into the patient's respiratory tract. Suction may be applied by depressing the suction valve 28 to remove the secretions from the patient. If it is desired to capture the secretions, a sputum trap 40 can be connected to the sputum trap port 32 and suction applied thereafter by depressing the suction valve 28. A sample of the secretions is then diverted into the sputum trap 40 for collection. Once sufficient sample has been collected, the sputum trap 40 may be disconnected, automatically closing it, and the trap 40 sent to a lab for analysis.
The sample may also desirably be analyzed while it is still in the sputum trap. This procedure would provide a more immediate result than sending a sample to a lab located some distance from the patient. Such a result would potentially have cost advantages because proper (i.e. more targeted) antibiotics could be administered to the patient earlier in his treatment.
The valve, handle and sputum trap may be made from plastics like polyolefins and nylon. The sputum trap is desirably transparent so that the user may see if a sample has been collected.
While the disclosure has been described in detail with respect to specific embodiments thereof, it will be apparent to those skilled in the art that various alterations, modifications and other changes may be made to the disclosure without departing from the spirit and scope of the present disclosure. It is therefore intended that the claims cover all such modifications, alterations and other changes encompassed by the appended claims.
1. A device for sampling bodily fluids comprising a handle having a lumen,
- a distal end of said handle adapted to connect to a sampling device and in fluid communication with said lumen;
- a vacuum connection on a proximal end of said handle and also in fluid communication with said lumen;
- a diverter valve in fluid communication with said lumen to direct a sample from a patient into a sputum trap when said trap is connected to said handle.
2. The device of claim 1 further comprising a suction valve in fluid communication with said lumen to control the application of vacuum.
3. The device of claim 2 wherein said diverter valve is located proximal to said suction valve.
4. The device of claim 3 further comprising a saline port in fluid communication with said lumen.
5. The device of claim 4 wherein said saline port is located distal to said suction valve.
6. The device of claim 1 wherein said sampling device is a suction catheter, a deep lung suctioning catheter, a bronchoscope, tubing or other airway suction catheter device.
7. The device of claim 1 further comprising a loss prevention media is said sputum trap to prevent said sample from escaping.
8. The device of claim 7 wherein said loss prevention media is a nonwoven fabric, breathable film or combination thereof.
9. A diverter valve for taking a sample from a patient comprising a valve body containing a valve having a first position in which a distal end of said valve is in fluid communication with a source of vacuum and a second position in which said distal end of said valve is in fluid communication with a sputum trap and said sputum trap is in fluid communication with said source of vacuum.
10. The diverter valve of claim 9 wherein said valve is moved from said first position to said second position by the connection of said sputum trap to said valve body.
11. The diverter valve of claim 10 wherein said valve is moved from said first position to said second position by the connection of said sputum trap to said valve body by twisting said valve body in a keyway in said sputum trap.
12. The diverter valve of claim 9 further comprising a loss prevention media is said sputum trap to prevent said sample from escaping.
13. The diverter valve of claim 12 wherein said loss prevention media is a nonwoven fabric, breathable film or combination thereof.
Filed: Oct 7, 2011
Publication Date: Apr 19, 2012
Inventors: Scott M. Teixeira (Cumming, GA), Andrew T. Baker (Norcross, GA), Brian J. Cuevas (Cumming, GA), Andrienne A. Hershey (Cumming, GA), Kok-Ming Tai (Lawrenceville, GA), Benone Tarcau (Lawrenceville, GA), Joseph A. Cesa (Cumming, GA), Amy G. Williams (Cumming, GA)
Application Number: 13/268,009
International Classification: A61B 5/00 (20060101);