Handheld Device for Drawing, Collecting, and Analyzing Bodily Fluid
A handheld device for drawing, collecting, and analyzing bodily fluid includes a body having a lumen defined therein, a plunger configured to be user-actuated, and a base. Multiple needles are fixed to the plunger, and at least one of the needles is configured to pass through the apertures of the base and penetrate a subject's skin to release bodily fluid when the plunger is actuated. After the plunger is actuated, a mechanism retracts the plunger from the subject's skin and creates a vacuum within the lumen. A network of passages on the base is configured to collect at least some of the bodily fluid and communicate the bodily fluid to one or more sensing areas for analysis.
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The present application claims priority to U.S. Provisional Patent Application Ser. No. 61/590,644, filed Jan. 25, 2012, and U.S. Provisional Patent Application Ser. No. 61/674,415, which are hereby incorporated herein by reference in their entirety.
FIELD OF THE INVENTIONThe present technology relates to medical devices, and in particular, handheld bodily fluid sensing devices for the extraction and subsequent handling of bodily fluids.
BACKGROUND OF THE INVENTIONThe following description is provided to assist the understanding of the reader. None of the information provided or references cited is admitted to be prior art to the present technology.
Current handheld medical devices for bodily fluid extraction, such as lancet finger punctures and syringe blood draws, typically involve a single needle making a single puncture site for fluid extraction. Mechanically or electrically actuated spring-loaded needles are used to achieve high velocity skin penetration to ensure the level of reliability required to draw blood from a single needle. If the device prematurely actuates, or if the subject flinches when the device is triggered, proper skin penetration may not occur. Furthermore, high velocity skin penetration can often be painful for the subject. Once bodily fluid is extracted and collected, an additional step is necessary in order to analyze the fluid, as the analysis step is not integrated into current devices. This results in a need for a low velocity device which functions to collect and analyze bodily fluid in a single, integrated design.
BRIEF SUMMARY OF THE INVENTIONA device includes a body with a proximal end, a distal end, an outer surface, and an inner surface. A base is attached to the distal end of the body. The base includes an outer face, an inner face, multiple apertures, one or more sensing areas, and a network of passages in communication with the apertures and the one or more sensing areas. The device also includes a plunger with a proximal end and a distal end with a face. The distal end of the plunger is configured to be inserted into the proximal end of the body, and the plunger is configured to be user-actuated from the proximal end of the body to the distal end of the body. Multiple needles are fixed to the face of the plunger, and at least a portion of each of the needles is configured to extend through the apertures of the base and beyond the outer surface of the base when the plunger is actuated to the distal end of the body. The device also includes a mechanism configured to retract the face of the plunger from: the distal end of the body to the proximal end of the body and create a vacuum within the body. At least one of the needles is configured to pass through the apertures of the base and penetrate a subject's skin to release bodily fluid. The network of passages of the base is configured to collect at least some of the bodily fluid and communicate the bodily fluid to the one or more sensing areas.
In another aspect, a method of using a device is provided. The device is provided includes a body with a proximal end, a distal end, an outer surface, and an inner surface. A base is attached to the distal end of the body. The base includes an outer face, an inner face, multiple apertures, one or more sensing areas, and a network of passages in communication with the apertures and the one or more sensing areas. The device also includes a plunger with a proximal end and a distal end with a face. The distal end of the plunger is configured to be inserted into the proximal end of the body, and the plunger is configured to be user-actuated from the proximal end of the body to the distal end of the body.
Multiple individual needles are fixed to the face of the plunger, and at least a portion of each of the needles is configured to extend through the various apertures of the base and beyond the outer surface of the base when the plunger is actuated to the distal end of the body. The device also includes a mechanism configured to retract the face of the plunger from the distal end of the body to the proximal end of the body and create a vacuum within the body. At least one of the needles is configured to pass through the apertures of the base and penetrate a subject's skin to release bodily fluid. The network of passages of the base is configured to collect at least some of the bodily fluid and communicate the bodily fluid to the one or more sensing areas. The outer face of the base is placed on a subject's skin. The plunger is manually actuated toward the distal end of the body to cause the needles to pass through the apertures and at least one of the needles to penetrate the subject's skin. The plunger is retracted from the distal end of the body to the proximal end of the body causing a vacuum to form in a space defined by the face of the plunger, the inner surface of the body, and the inner face of the base and drawing bodily fluids from the subject's skin into the network of passages of the base. The bodily fluid is directed through the network of passages of the base to the one or more sensing areas for analysis.
While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. As will be realized, the invention is capable of modifications in various obvious aspects, all without departing from the spirit and scope of the present invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.
Referring generally to the figures, a handheld device is used to draw, collect, and analyze bodily fluid. The handheld device includes of a body with a distal end and a proximal end, a plunger with a face, and a base with multiple apertures, a network of passages, and one or more sensing areas. Multiple needles are fixed to the face of the plunger and aligned such that when a user actuates the device, the needles are guided to pass through the multiple independent apertures of the base. The base is attached to the distal end of the body. The handheld device is user-actuated. A user places the device on a subject's skin and actuates the handheld device by displacing the plunger from the proximal end of the body to the distal end of the body. The displacement of the plunger guides at least a portion of each of the needles fixed to the face of the plunger to pass through the apertures on the base and at least one of the needles penetrates the subject's skin, drawing bodily fluid.
Typical handheld devices for collection of bodily fluid only contain one needle that is electrically or mechanically actuated and must puncture a subject's skin at a high velocity, inflicting a nontrivial amount of pain. The high velocity penetration is necessary to ensure the level of reliability required to draw blood from a single needle. High-velocity needle actuation has thus been preferred because prior art low-velocity systems may not penetrate the skin deeply or reliably enough to ensure that bodily fluid may be extracted, or run the risk of insufficient bodily fluid sample volume. However, in typical devices and applications using high velocity penetration and employing only one needle, the devices are not always successful in drawing blood upon actuation, in part because there is no redundancy. In other known applications and devices, such as patches, microarrays are employed to address this known problem, but utilize arrays of needles that are extremely dense. In such devices, although multiple needles are employed, they are typically concentrated, which may also induce a non-trivial amount of pain and does little to increase the efficacy of fluid collection, as the punctures are all highly localized around a single site, and thus all penetrate the same region of skin, thereby localizing on a single capillary, arterial or other fluid dispersion region. In the many subjects, this may not provide significant coverage to reliably produce a sample. Furthermore, the redundancy of multiple needles for multiple puncture sources does not introduce the needed redundancy for fluidic handling failure, as the cluster of needles is still isolated to a single fluid handling passage.
The various embodiments of the handheld device described herein achieve higher reliability than that observed in the prior art by drawing blood using multiple needles spaced amongst numerous independent sites, thereby utilizing a system that can accommodate less than all of the independent collection sites drawing blood while remaining effective. These handheld devices are user-actuated, thus the needles puncture the subject's skin at a low velocity, minimizing pain while maintaining the increased efficacy and reliability readily observed when drawing from a plurality of distinct sites. When a user actuates the handheld device, and the needles are guided through the apertures on the base, not all of the needles need to penetrate the subject's skin, but enough bodily fluid is drawn by at least one of the needles for the handheld device to work effectively.
In addition, typical handheld devices only perform the step of collecting bodily fluid; they require the transfer of the fluid to a separate system for analysis. The handheld device described herein allows the drawing and analysis of bodily fluid in a single, integrated platform. When a user actuates device and at least one of the needles penetrates the subject's skin, a mechanism retracts the plunger from the distal end to the proximal end of the body, retracting the needles from the subject's skin and creating a vacuum within the body, enhancing fluid extraction and causing bodily fluid to pool on the surface of the skin. The vacuum contributes to the reliability of the handheld device, optimizing fluid extraction from puncture sites where needles penetrate the subject's skin and at the same time minimizing the size of the puncture sites. The bodily fluid is then collected by the network of the passages on the base and directed to one or more sensing areas for analysis. To further enhance reliability, the network of passages may include U-shaped channels that handle the bodily fluid without worrying about air bubbles causing fluid flow failure. Additionally, synchronization of multiple sub-channels is not necessary in order for the handheld device to properly conduct bodily fluid analysis. The handheld device thus eliminates the need for employing an additional step for analysis and provides a simple and effective mechanism for drawing, collecting, and analyzing bodily fluid.
Referring now to the figures, the handheld device for drawing and analyzing bodily fluids will be described in detail.
In these exemplary embodiments, when a user actuates the handheld device 10 by imparting a force on the plunger 18, the plunger 18 is displaced towards the distal end 16 of the body 12 through the lumen 22. Once the plunger 18 reaches its full displacement, a mechanism for retracting the plunger 18 is triggered. In the embodiment shown in
By increasing the number of the plurality of needles 30, the handheld device 10 increases the probability of extracting a proper amount of bodily fluid. The configuration of the plurality of needles 30 thereby ensures bodily fluid extraction but without as much pain as is caused by a single, high velocity needle used in typical handheld fluid extraction devices or array devices. This approach also lowers the variability induced by the number of capillaries present at various locations on the subject's skin and differences or defects in the manufacturing of the plurality of needles 30. Additionally, the low velocity needle penetration allows a simple design for the handheld device 10, as low velocity needle penetration requires fewer mechanical parts than a typical high velocity device.
In one embodiment, bodily fluid extracted by the plurality of needles 30 may be blood. In another embodiment, bodily fluid extracted may be interstitial fluid. Once bodily fluid is extracted from the subject and begins to pool on the subject's skin, the mechanism for retracting the plunger 18 is activated. The spring 24 retracts the plunger 18 through the lumen 22 from the distal end 16 to the proximal end 14 of the body 12, removing the plurality of needles 30 from the subject's skin and creating a vacuum in the vacuum creation space 22, which is the portion of the lumen 22 distal to the plunger 18. In an alternative embodiment, a membrane (not shown) may be attached to the membrane tethering area 26, and the membrane retracts the plunger 18 from the distal end 16 to the proximal end 14 of the body 12 through the lumen 22, removing the plurality of needles 30 from the subject's skin and creating a vacuum in the lumen 22 distal to the plunger 18. The vacuum created in the lumen 22 creates a vacuum at each of the fluid extraction sites 32, thereby enhancing the pooling of bodily fluid on the subject's skin, optimizing fluid extraction from each puncture site where one of the plurality of needles 30 penetrates the subject's skin, and at the same time minimizing the size of each puncture site. The vacuum created may be from greater than 0 Pa to 75,000 Pa.
When a user actuates the handheld device 10, resulting in bodily fluid pooling in at least one of the fluid extraction sites defined by the plurality of apertures 32 in the base 20, the network of passages 34 collects the bodily fluid pooling on the surface of the subject's skin from at least one of the fluid extraction sites. The network of passages 34 collects bodily fluid from any fluid extraction site in which fluid extraction by the plurality of needles 30 was successful. In the embodiment shown in
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In an exemplary embodiment of the handheld device 220 depicted in
In an exemplary embodiment of the handheld device 240 depicted in
In an exemplary embodiment of the handheld device 260 depicted in
According to the handheld device 400 embodiment of
In the embodiments depicted in
Although the present invention has been described with reference to preferred embodiments, persons skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention.
Claims
1. A device comprising:
- a. a body comprising a proximal end, a distal end, an outer surface, and a lumen defined within the body;
- b. a base attached to the distal end of the body, the base comprising an outer face, an inner face, a plurality of apertures, at least one sensing area, and a network of passages in communication with the plurality of apertures and the at least one sensing area;
- c. a plunger comprising: i. a proximal end; and ii. a distal end comprising a face; iii. wherein the distal end of the plunger is configured to be disposed within the lumen at the proximal end of the body and the plunger is configured to be user-actuated within the lumen from the proximal end of the body to the distal end of the body; and
- d. a plurality of needles fixed to the face of the plunger, wherein at least a portion of each of the plurality of needles is configured to extend through the plurality of apertures of the base and beyond the outer face of the base when the plunger is actuated to the distal end of the body;
- e. wherein: i. at least one of the plurality of needles is configured to pass through the plurality of apertures of the base and penetrate a subject's skin to release bodily fluid; and ii. the network of passages of the base is configured to collect at least some of the bodily fluid and communicate the bodily fluid to the at least one sensing area.
2. The device of claim 1, further comprising a mechanism configured to retract the face of the plunger within the lumen from the distal end of the body to the proximal end of the body and create a vacuum within the lumen.
3. The device of claim 2 wherein the mechanism further comprises a spring.
4. The device of claim 2 wherein the mechanism further comprises an elastic membrane.
5. The device of claim 2, wherein the vacuum created by the mechanism is from greater than 0 Pa to 75,000 Pa.
6. The device of claim 1, further comprising at least one pre-loaded spring, wherein the preloaded spring is activated by the actuation of the plunger so as to return the plunger to its original location following actuation.
7. The device of claim 1, further comprising a one-way valve.
8. The device of claim 1, wherein the outer face of the base comprises an adhesive configured to releaseably adhere the device to the subject's skin.
9. The device of claim 1, wherein the plurality of apertures comprises from two to 100 apertures.
10. The device of claim 1, wherein the plurality of needles comprises a plurality of microneedles.
11. The device of claim 1, wherein each of the needles has a gauge from 29 gauge to 40 gauge.
12. The device of claim 1, wherein the network of passages comprises tubes, microfluidic channels, or paper channels.
13. The device of claims 1, wherein the at least one sensing area further comprises a sensing apparatus, said sensing apparatus selected from a group consisting of: an electrical sensing apparatus, an audial sensing apparatus, and a visual sensing area.
14. The device of claim 1, wherein the bodily fluid is blood or interstitial fluid.
15. A method comprising:
- a. providing a handheld device for drawing, collecting, and analyzing bodily fluid, the device comprising: i. a body comprising a proximal end, a distal end, an outer surface, and a lumen defined within the body; ii. a base attached to the distal end of the body, the base comprising an outer face, an inner face, a plurality of apertures, at least one sensing area, and a network of passages in communication with the plurality of apertures and the at least one sensing area; iii. a plunger comprising: 1. a proximal end; and 2. a distal end comprising a face; 3. wherein the distal end of the plunger is configured to be disposed within the lumen of the body and the plunger is configured to move between the proximal end of the body and the distal end of the body; and iv. a plurality of needles fixed to the face of the plunger, wherein at least a portion of each of the plurality of needles is configured to extend through the plurality of apertures of the base and beyond the outer face of the base when the plunger is actuated to the distal end of the body; v. wherein: 1. at least one of the plurality of needles is configured to pass through the plurality of apertures of the base and penetrate a subject's skin to release bodily fluid; and 2. the network of passages of the base is configured to collect at least some of the bodily fluid and communicate the bodily fluid to the at least one sensing area;
- b. placing the outer face of the base on a subject's skin;
- c. manually actuating the plunger within the lumen toward the distal end of the body to cause the plurality of needles to pass through the plurality of apertures of the base and at least one of the plurality of needles to penetrate the subject's skin;
- d. retracting the plunger from the distal end of the body to the proximal end of the body, thereby causing a vacuum to form in the lumen and drawing bodily fluid from the subject's skin into the network of passages of the base; and
- e. directing the bodily fluid through the network of passages of the base to the at least one sensing area for analysis.
16. The method of claim 12, further comprising providing a mechanism configured to retract the face of the plunger from the distal end of the body to the proximal end of the body and create a vacuum within the lumen;
17. The method of claim 16, wherein the mechanism comprises a spring or an elastic membrane.
18. The method of claim 16, wherein the bodily fluid is blood or interstitial fluid.
19. The method of claim 16, wherein the retracting comprises removal of the manual activation force from the plunger.
20. The method of claim 16, wherein the retracting comprises activation of an internal mechanism triggered when the user-provided force imparted on the plunger pushes the plunger past a trigger point.
21. The method of claim 20, wherein the internal mechanism is a preloaded spring.
22. The method of claim 15, wherein the vacuum is from greater than 0 Pa to 75,000 Pa.
23. The method of claim 15 further comprising: providing a readout from the at least one sensing area that is electrical, visual, or auditory.
24. The device of claim 16, further comprising providing a one-way valve, wherein the one-way valve creates the vacuum.
Type: Application
Filed: Jan 25, 2013
Publication Date: Aug 15, 2013
Applicant: TASSO, INC. (Madison, WI)
Inventor: TASSO, INC.
Application Number: 13/750,526
International Classification: A61B 5/151 (20060101); A61B 5/15 (20060101); A61B 5/157 (20060101);