Patent Grant
9198610
The present disclosure relates to blood sampling with vascular access devices. Blood sampling is a common health care procedure involving the withdrawal of at least a drop of blood from a patient. Blood samples are commonly taken from hospitalized, homecare, and emergency room patients either by finger stick, heel stick, or venipuncture. Once collected, blood samples are analyzed via one or more blood test levels.
Blood tests determine the physiological and biochemical states of the patient, such as disease, mineral content, drug effectiveness, and organ function. Blood tests may be performed in a laboratory, a distance away from the location of the patient, or performed at the point of care, near the location of the patient. One example of point of care blood testing is the routine testing of a patient's blood glucose levels, which involves the extraction of blood via a finger stick and the mechanical collection of blood into a diagnostic cartridge. Thereafter the diagnostic cartridge analyzes the blood sample and provides the clinician a reading of the patient's blood glucose level. Other devices are available which analyze blood gas electrolyte levels, lithium levels, ionized calcium levels. Furthermore, some point of care devices identify markers for acute coronary syndrome (ACS) and deep vein thrombosis/pulmonary embolism (DVT/PE).
Despite the rapid advancement in point of care testing and diagnostics, blood sampling techniques have remained relatively unchanged. Blood samples are frequently drawn using hypodermic needles, or vacuum tubes coupled to a proximal end of a needle or a catheter assembly. In some instances, clinicians collect blood from a catheter assembly using a needle and syringe that is inserted into the catheter to withdraw blood from a patient through the inserted catheter. These procedures utilize needles and vacuum tubes as intermediate devices from which the collected blood sample is typically withdrawn prior to testing. These processes are thus device intensive, utilizing multiple devices in the process of obtaining, preparing, and testing blood samples. Furthermore, each device required adds time and cost to the testing process. Accordingly, there is a need for more efficient blood sampling and testing devices and methods.
The present invention has been developed in response to problems and needs in the art that have not yet been fully resolved by currently available blood sampling devices and methods. Thus, these devices, and methods are developed to provide more efficient blood sampling and diagnosis.
The present blood sampling device and method for blood sampling significantly reduce the number of components that are required in order to obtain a diagnostic blood sample immediate after IV insertion. Embodiments of the blood sampling device combines features that obtain, prepare, and directly test blood samples during the normal process of venous access. These embodiments, facilitate the entire blood sampling process for clinicians by reducing the number of process steps and reducing the amount of time between sampling and obtaining test results.
In one aspect, a blood sampling device has a body that is shaped and sized for being partial inserted into a separate vascular access device, such as a catheter, a needle. The body further defines a reservoir within the body, and the reservoir has an internal volume sufficient to contain enough blood for use in a diagnostic blood test. A gas permeable vent is disposed on the body in gaseous communication with the reservoir to enable blood to flow into the reservoir under the force of the patient's blood pressure, as gas flows out the vent.
Implementations may include one or more of the following features. A diagnostic reagent may be disposed within the reservoir. An on-board diagnostic cartridge may be in fluid communication with the reservoir. The body may include a compressible portion that is shaped and sized to eject the contents of the reservoir when compressed. The reservoir may include multiple chambers. When the reservoir includes multiple chambers, at least one of the multiple chambers may include a diagnostic reagent. The reservoir may include a blood preservative. The body may include an indicator of elapsed time since blood sampling. The reservoir may include a distal opening that is in fluid communication with the separate vascular access device when the body is partially inserted into the separate vascular access device. The body may include a male luer adapter shaped and sized for insertion into the separate vascular access device, and the distal opening may be a distal opening of the male luer adapter. The distal opening may include a wicking material disposed therein. The distal opening may include a flow restrictor. The body may include a luer adapter for insertion into the separate vascular access device.
In another aspect, a blood sampling device includes a body shaped and sized for partial insertion into a separate vascular access device. The body defines a reservoir within the body, the reservoir having an internal volume of at least 0.1 μL. A gas permeable vent is disposed on the body, the gas vent in gaseous communication with the reservoir. And a diagnostic component is in fluid communication with the reservoir.
Implementations may include one or more of the following features. The diagnostic component may include an on-board diagnostic cartridge. The diagnostic component may include a diagnostic reagent disposed within the reservoir. The reservoir may include multiple chambers, and at least two of the multiple chambers may include a separate diagnostic component.
In yet another aspect, a blood sampling device includes a body shaped and sized for partial insertion into a separate vascular access device. The body has a compressible portion and a reservoir defined within the body. The compressible portion of the body is shaped and sized to eject at least a portion of the contents of the reservoir when it is compressed. The reservoir has an internal volume of at least 0.1 μL. A gas permeable vent is disposed on the body in gaseous communication with the reservoir. Implementations may include one or more of the following features. The reservoir may have an internal volume of less than 10 mL, or in some embodiments, the internal volume is less than 2 mL. And the reservoir may include a blood preservative.
In still another aspect, a method for blood sampling using a ventable blood sampling device includes inserting a vascular access device into the vasculature of a patient. Next, the method includes inserting a blood sampling device into the vascular access device, the blood sampling device including a body shaped and sized for partial insertion into a separate vascular access device; a reservoir defined within the body, the reservoir having an internal volume sufficient to contain enough blood for use in a diagnostic blood test; and a gas permeable vent disposed on the body, the gas vent in gaseous communication with the reservoir. The method finally includes causing blood to flow from the vasculature of the patient into the blood sampling device to fill the reservoir with blood. Implementations may further include causing to flow by at least one of blood pressure and wicking.
These and other features and advantages of the present invention may be incorporated into certain embodiments of the invention and will become more fully apparent from the following description and appended claims, or may be learned by the practice of the invention as set forth hereinafter. The present invention does not require that all the advantageous features and all the advantages described herein be incorporated into every embodiment of the invention.
In order that the manner in which the above-recited and other features and advantages of the invention are obtained will be readily understood, a more particular description of the invention briefly described above will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. These drawings depict only typical embodiments of the invention and are not therefore to be considered to limit the scope of the invention.
The presently preferred embodiments of the present invention will be best understood by reference to the drawings, wherein like reference numbers indicate identical or functionally similar elements. It will be readily understood that the components of the present invention, as generally described and illustrated in the figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description, as represented in the figures, is not intended to limit the scope of the invention as claimed, but is merely representative of presently preferred embodiments of the invention.
The present invention relates to a blood sampling device that may collect a blood sample from a variety of extravascular system.
Referring now to
As shown, a blood sampling device 102 may be inserted into a port 120 of the Y adapter 104 to collect a blood sample therefrom. Alternatively, as shown in
After the introducer needle 116 is withdrawn from the extravascular system 100 both ports of the Y adapter 104 are closed. At this point blood is contained within the system 100. The clamp 110 on the integrated extension tubing 108 may then selectively limit or eliminate blood flow to the blood sampling device 102. As the clamp 110 opens the extension tubing 108, blood flows into the blood sampling device 102 to fill the internal reservoir with enough blood for an adequate blood sample. Generally, an adequate blood sample includes between 0.1 μL-200 mL of blood.
Referring now to
Upon inserting into an open extravascular system, the blood sampling device 102 draws blood therein. In some embodiments, blood flows into the blood sampling device 102 under venous pressure. Referring back to
In other embodiments, blood is drawn into the blood sampling device using, at least in part, other power sources. For examples, in some embodiments, the blood sampling device is a vacuum tube that draws blood therein using vacuum force. In other embodiments, blood is drawn into the blood sampling device using a pump or a syringe. In other embodiments, the blood sampling device receives blood via a wicking means disposed within the distal end of the blood sampling device. In some embodiments, the wicking material comprises micro fluidics.
After the blood sampling device collects an appropriate blood sample, the sample can be analyzed. With continued reference to
Referring now to
In some embodiments, the body 312 is shaped and sized for insertion into an extravascular system, as previously discussed. In some embodiments, the distal end of the body includes a male coupler 356 in the form of an elongate stem or cannula, such as the shown in
As discussed above, in some embodiments, a gas permeable vent 304 is disposed on the body 312 to allow airflow to pass therethrough and to prevent fluid, such as blood from passing therethrough. This gas permeable vent 304 is in fluid communication with the reservoir 302. The vent may be hydrophobic or hydrophilic and may be a glass, polyethylene terephthalate (PET), a microfiber material, or other synthetic material made of high-density polyethylene fibers, such as TYVEK® material from DuPont. As shown, the gas permeable vent 304 is disposed on a proximal end of the body 312. However, in other embodiments, the gas permeable vent 304 is located on other surfaces or portions of the body 312. For instance, in some embodiments, the gas permeable vent 304 is disposed on a side of the body. Furthermore, more than one gas permeable vent 304 can be disposed on the body 312. For instance, when more than one chamber is included in the reservoir 302, each chamber can have a separate gas permeable vent 304.
Because different blood tests required different quantities of blood, in some embodiments, the reservoir is sized to retain a quantity of blood needed for a specific blood test or for a specific number of blood tests. In some embodiments, a set of blood sampling devices is provided to a clinician having multiple blood sampling devices of different sizes. Accordingly,
As shown in
In some embodiments, the body has no compressible portion, but is rigid. As such, to extract the blood sample, in some embodiments a wicking means is inserted into the blood sampling device and wicked therefrom. In other embodiment, blood is merely poured out of the distal opening of the blood sampling device. In other instances, the gas permeable membrane is pierced to enable blood to flow out the distal opening. In still other embodiments, blood is withdrawn with a needle and syringe.
Since some blood samples may not be immediately tested, in some embodiments the blood sampling device contains one or more preservative within the reservoir 302 to preserve the blood for later testing. Referring now to
Furthermore, in some embodiments, the blood sampling device includes a time indicator 520 that provides an indication to the clinician or laboratory technician the amount of time has elapsed since the sample was taken. In some embodiments, the time indicator 520 is external to the reservoir, such as a color changing sticker that changes color based on elapsed time and/or temperature. In other embodiments, the time indicator 520 is a time stamp. In other embodiments, the time indicator 520 indicates the passage of time in which the blood sample is no longer useful, such as an expiration time. In some embodiments, the time indicator 520 is disposed within the reservoir and is activate by contact with the blood sample.
Additionally or alternatively, the blood sample can be tested within the blood sampling device. In some embodiments, the reservoir includes one or more diagnostic reagent disposed within the reservoir 302 that reacts with the blood sample and provides a visual indication to the clinician. Diagnostic reagents can indicate a patient's physiological and biochemical states, such as disease, mineral content, drug effectiveness, and organ function. Referring now to
In some embodiments, different diagnostic reagents are kept separate to enable more accurate results. Accordingly, as shown in
In some embodiments, the reservoir chambers 608, 610, 612 are also separated by a distal flow restrictor 620. The flow restrictor 620 limits fluid communication between each chamber by limiting the speed at which fluid passes therethrough. Accordingly, once blood passes through the filter and mixes with the reagent it is partially limited by the flow restrictor 620 from exiting the chamber and entering another reservoir chamber by the flow restrictor 620. In some embodiments, the flow restrictor includes a continuous, porous filter that spans the reservoir cross section and limits the speed at which fluid passes therethrough. Alternative examples of flow restrictors are illustrated in
In some embodiments, the divider portions 654 of the body 652 extend distally to the male coupler 306. In other embodiments, the divider portions 654 of the body 652 extend into the male coupler 306, such that fluid is segregated into the various chambers immediately upon entry into the blood sampling device 650. In still other embodiments, the divider portions 654 of the body 652 extend only partially into the male coupler 306. In yet other embodiments, the divider portions 654 of the body 652 do not extend all the way to the male coupler 306, but extend only partially between the proximal and the distal ends of the reservoir 302, similar to that shown in
Referring now to
Referring now to
In some embodiments, a flow restrictor is disposed within the male coupler 702. Thus positioned, as the blood sampling device is removed from the separate vascular access device the flow restrictor prevent exposure to blood otherwise within the male coupler 702. In other embodiments, the flow restrictor is disposed with the reservoir of the blood sampling device, as explained above.
Referring now to
Reference will now be made to
On-board diagnostic cartridges, thus, enable a clinician to receive electronic analysis of a blood sample at the point of care and in a relatively short period of time. Referring now to
In some embodiments, the on-board diagnostic cartridge 904 is integrated into the body 910 of the blood sampling device 900. In other embodiments, the on-board diagnostic cartridge 904 is selectively coupled to the body 910 and selectively removable from the body 910. Accordingly, in some embodiment the body 910 includes a slot, latch, clip, or channel for receiving a selectively removable on-board diagnostic cartridge 904.
As stated above, the on-board diagnostic cartridge 904 employs internal analysis capabilities. Thus, in some embodiments, the on-board diagnostic cartridge 904 includes an internal circuit board; a power source, such as a battery; and appropriate components necessary to separate the blood into components and analyze the blood. To display the results of the analysis the on-board diagnostic cartridge 904 includes a display. In some embodiments, the display is a LCD display 954 (shown in
The blood sampling device having an on-board diagnostic cartridge 904 combines features of medical technology that obtain, prepare, and directly test blood samples into a single, easy to use device. Such a device reduces the number of process steps and reduces the amount of time between sampling and obtaining test results.
From the foregoing it will be seen that a blood sampling device can be utilized to collect a blood sample from a patient. Accordingly, a method for blood sampling using a ventable blood sampling device involves, first, inserting a vascular access device into the vasculature of a patient. As illustrated in
Next, the blood sampling device is inserted into the vascular access device. In some embodiments, the blood sampling devices includes a distal male coupler of the body of the blood sampling device includes a threaded male luer connector. In other embodiments, the distal male coupler comprises a projection having an interior lumen, but has no threads.
Lastly, blood is caused to flow from the vasculature of the patient into the blood sampling device to fill the reservoir of the blood sampling device with blood. In some embodiments, blood flow into the reservoir is powered by venous pressure from the patient, and facilitated by the inclusion of a gas permeable vent in fluid communication with the reservoir. As venous pressure forces blood into the reservoir, the gas permeable vent allows gases within the reservoir to escape through the vent. In other embodiments, blood flow into the reservoir is powered by a vacuum within the reservoir. In still other embodiments, blood flow into the reservoir is powered by a syringe coupled to the body of the blood sampling device.
Thus, the present blood sampling device and method for blood sampling significantly reduce the number of components that are required in order to obtain a diagnostic blood sample immediate after IV insertion. As described herein, embodiments of the blood sampling device may combines features that obtain, prepare, and directly test blood samples during the normal process of venous access. These embodiments, facilitate the entire blood sampling process for clinicians by reducing the number of process steps and reducing the amount of time between sampling and obtaining test results.
The present invention may be embodied in other specific forms without departing from its structures, methods, or other essential characteristics as broadly described herein and claimed hereinafter. The described embodiments are to be considered in all respects only as illustrative, and not restrictive. The scope of the invention is, therefore, indicated by the appended claims, rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.
This application is a divisional of application Ser. No. 12/831,891, filed Jul. 7, 2010, now U.S. Pat. No. 8,383,044, and entitled BLOOD SAMPLING DEVICE, which claims the benefit of U.S. Provisional Application No. 61/224,208, filed Jul. 9, 2009, entitled CATHETER VENTING, BLOOD SAMPLING AND COLLECTION DEVICE FOR POINT OF USE DIAGNOSTIC TESTING. This application claims priority to and has incorporated herein by reference the utility and provisional application.
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