Patent Application
20240268729
The present disclosure relates to a wearable finger cuff device to aid in capillary blood sample collection. More specifically, the present disclosure relates to a patient-wearable finger cuff having a lancet guide opening and integrated absorbent pad.
Capillary blood draw is often preferable to venous blood draw, particularly in a non-clinical setting and/or small blood volume applications. Capillary collection relies upon a lancet to make a small puncture in, e.g., a patient's fingertip, which draws a smaller sample volume as compared to venous collection, and is generally more comfortable for the patient. Additionally, the lack of a hypodermic needle results in lower risk and less anxiety for the patient. In fact, because the process for capillary collection is relatively simple, patients themselves can be taught to collect a sample, making blood tests more accessible and less expensive.
However, when sample collection performed by the patient or another person without medical training, errors can be made during capillary blood draw which may negatively impact patient experience and sample quality. One such error is the puncture of the patient's finger in a less-than-ideal location. Generally, it is recommended that the finger puncture be performed at a slightly off-center location on the pad of the finger. If the puncture is executed outside of this preferred location, the result may be low blood flow from the puncture and/or pain for the patient.
Another possible error made by the patient or untrained assistant during capillary collection may be that the first drop of blood drawn from the finger is into the sample tube. Typically, it is recommended that the first drop of blood be wiped away with separate gauze (and, thus, not collected), as this first drop may contain contaminants that can impact the integrity of sample. Additionally, the first drop of blood may also contain platelet tissue factor, which can undesirably begin the blood clotting process and may prevent analysis from being performed.
Accordingly, a finger cuff device for use by a patient or untrained person during capillary blood collection, wherein the finger cuff device includes both a lancet guide opening located at an optimal puncture location and an integrated absorbent pad so as to ensure removal of the first drop of blood upon removal of the finger cuff device.
In accordance with an embodiment of the present disclosure, a finger cuff device for use in capillary blood sample collection includes a finger cuff having an open end portion sized to accommodate a user's finger, a finger stop end portion opposite the open end portion, an outer sidewall, an inner sidewall, and at least one lancet guide opening formed through the outer sidewall and inner sidewall. The finger cuff device also includes at least one integrated absorbent pad positioned on the inner sidewall of the finger cuff.
In certain configurations, the at least one lancet guide opening is positioned off-center from a centerline of the finger cuff. In other configurations, the at least one lancet guide opening is positioned proximate the finger stop end portion of the finger cuff. In still other configurations, the at least one lancet guide opening is elongated relative to a longitudinal axis of the finger cuff. Optionally, the at least one integrated absorbent pad is positioned on the inner sidewall in line with the at least one lancet guide.
In another configuration, the device includes a pair of open portions formed on respective sides of the finger cuff. Optionally, each open portion further comprises a rounded end portion. In certain arrangements, the finger cuff is formed of an elastic material.
In accordance with another embodiment of the present disclosure, a kit for capillary blood sample collection includes a lancet, a microtainer collection tube, at least one sterile wipe, a bandage, and a sterile finger cuff device. The sterile finger cuff device includes an open end portion sized to accommodate a user's finger, a finger stop end portion opposite the open end portion, an outer sidewall, an inner sidewall, at least one lancet guide opening formed through the outer sidewall and inner sidewall, and at least one integrated absorbent pad positioned on the inner sidewall of the finger cuff.
In certain configurations, the at least one lancet guide opening of the finger cuff is positioned off-center from a centerline of the finger cuff. The at least one lancet guide opening may be positioned proximate the finger stop end portion of the finger cuff. Optionally, the at least one lancet guide opening of the finger cuff is elongated relative to a longitudinal axis of the finger cuff. The at least one integrated absorbent pad of the sterile finger cuff device may be positioned on the inner sidewall in line with the at least one lancet guide. In one configuration, the sterile finger cuff device further includes a pair of open portions formed on respective sides of the finger cuff. Optionally, each open portion of the finger cuff further includes a rounded end portion. The finger cuff may be formed of an elastic material.
In accordance with another embodiment of the present invention, a method of capillary blood sample collection includes preparing a finger and desired puncture site for blood sample collection with a sterilized wipe, placing a sterile finger cuff device over the prepared finger at the desired puncture site, the sterile finger cuff device including an open end portion sized to accommodate a user's finger, a finger stop end portion opposite the open end portion, an outer sidewall, an inner sidewall, and at least one lancet guide opening formed through the outer sidewall and inner sidewall. The method also includes at least one integrated absorbent pad positioned on the inner sidewall of the finger cuff, pressing a lancet through the at least one lancet guide opening to puncture the finger at the desired puncture site, and removing the sterile finger cuff device from the finger to expose the puncture site and wipe away a first blood drop from the puncture site via the at least one integrated absorbent pad of the sterile finger cuff device.
In certain configurations, the method also includes collecting a blood sample in a microtainer tube after the first blood drop is wiped away from the puncture site via the at least one integrated absorbent pad of the sterile finger cuff device. Optionally, the method further includes closing the microtainer tube after collection of a desired volume of blood sample and bandaging the puncture site on the finger. In certain configurations, the method also includes placing the sterile finger cuff device over the prepared finger comprises placing the finger cuff on the finger such that the at least one lancet guide opening is positioned off-center of a centerline of the finger.
Further details and advantages of the invention will become clear upon reading the following detailed description in conjunction with the accompanying drawing figures, wherein like parts are designated with like reference numerals throughout.
The following description is provided to enable those skilled in the art to make and use the described aspects contemplated for carrying out the invention. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present disclosure.
For the purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the invention as it is oriented in the drawings. However, it is to be understood that the invention may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary aspects of the invention. Hence, specific dimensions and other physical characteristics related to the aspects disclosed herein are not to be considered as limiting.
Referring to
In the embodiment shown in
In some embodiments, the finger cuff device 10 is formed of an elastic material, thereby allowing the finger cuff device 10 to deflect when initially positioned on a user's finger, yet return toward an original position so as to better hold the finger cuff device 10 in place on the user's finger without additional securement via, e.g., another hand of the user, an adhesive such as medical tape, etc. The finger cuff device 10 may be formed of any appropriate elastic material capable of sterilization, such as, e.g., plastic, polymer, metal, etc. However, it is to be understood that other materials, including non-elastic materials, may be utilized.
Referring still to
The lancet guide opening 22 is sized to sufficiently accommodate at least a piercing tip of a lancet. In some embodiments, lancet guide opening 22 is elongated so as to enable the user to choose from several off-center puncture locations. An elongated lancet guide opening 22 may be beneficial for a user performing somewhat frequent blood collection procedures, as it may enable the user to avoid re-puncturing the same location with each collection event.
Furthermore, while not shown in
Additionally and/or alternatively, in some embodiments, at or near the lancet guide opening 22, the finger cuff 10 could incorporate a locking mechanism (not shown) capable of capturing the lancet after the finger puncture is performed. The locking mechanism would be configured to prevent removal of the lancet separate from removal of the finger cuff 10 in its entirety. Such a configuration would eliminate the need to separately dispose of the lancet and the finger cuff 10, minimizing the number of actions the user (or another person assisting the user) would need to take prior to collecting the capillary blood sample. Furthermore, due to the presence of the locked lancet, the user would be forced to fully remove the finger cuff 10 in order to access the puncture site, preventing attempted blood draw with the finger cuff 10 still in place on the user's finger.
Referring still to
As noted above, during typical capillary blood collection, it is preferable for the first blood drop to be wiped away by the user via a separate gauze pad prior to blood collection. This additional step adds complexity to the procedure, and may even be overlooked entirely, particularly when the collection procedure is being performed by the patient themselves or another inexperienced user. However, integrated absorbent pad 24 of finger cuff 10 prevents such an oversight, as removal of the finger cuff 10 after puncture necessarily causes the absorbent pad 24 to pass over the puncture site, thereby removing the first blood drop without the need for an additional wiping step. Additionally, the location of the absorbent pad 24 helps to minimize discomfort during removal of the finger cuff 10, as it substantially protects the puncture site from contact with other surfaces of the finger cuff 10 during removal.
While not shown, it is to be understood that more than one absorbent pad 24 may be provided on interior sidewall 14 and/or on other locations of finger cuff 10. For example, if more than one lancet guide opening 22 is provided in finger cuff 10, an associated absorbent pad 24 may be provided relative to each lancet guide opening 22. Additionally and/or alternatively, the size of absorbent pad 24 is not limited to that which is shown in
Referring now to
Referring to
As detailed above, the finger cuff 10 simplifies capillary blood sample collection by the patient themselves and/or another unskilled person, ensuring that an appropriate puncture site is selected and that the first blood drop is wiped away prior to collection. As the finger cuff 10 incorporates the lancet guide opening 22 and absorbent pad 24 in a single device, single-handed collection by the user themselves is also made possible. Moreover, as the finger cuff 10 merely facilitates a proper sample collection technique and does not itself impact sample quality, few risks to the patient and/or the sample are possible.
In some embodiments, the finger cuff 10 may be provided as part of an overall sample collection provided to the user for at-home capillary blood sample collection. The kit may include, e.g., a lancet, a microtainer collection tube, at least one sterile wipe, the sterile finger cuff 10, and a bandage for use on the puncture site post-collection.
Next, referring to
Next, at step 108, the user (or other person) removes the finger cuff from the finger, which simultaneously exposes the puncture site and wipes the first blood drop from the puncture site, as described above with respect to
After appropriate removal of the finger cuff and the first blood drop, at step 110, the user (or other person) can utilize an appropriate capillary-collection microtainer tube in order to obtain a required sample volume. Then, upon collection of the required sample volume, at step 112, the user (or other person) may close the microtainer tube with an appropriate cap or lid and bandage the user's finger at the puncture site.
Using method 100, a capillary blood sample can be obtained from a preferred off-center puncture site on the user's finger, with minimal opportunity for user error. Additionally, because the absorbent pad is integrated within the finger cuff, the first blood drop is simultaneously wiped away from the puncture site with removal of the finger cuff. In this way, the method 100 avoids an extra wiping step that is, at the very least, cumbersome to a user obtaining their own sample, and is often overlooked or skipped altogether.
While several embodiments of a finger cuff with a lancet guide and integrated absorbent pad (and a method of its use in capillary blood collection) were described in the foregoing detailed description, those skilled in the art may make modifications and alterations to these embodiments without departing from the scope and spirit of the invention. Accordingly, the foregoing description is intended to be illustrative rather than restrictive. The invention described hereinabove is defined by the appended claims and all changes to the invention that fall within the meaning and the range of equivalency of the claims are embraced within their scope.
The present application claims priority to U.S. Provisional Application Ser. No. 63/197,784, entitled “Finger Cuff with Lancet Guide and Integrated Absorbent Pad for Capillary Sample Collection”, filed Jun. 7, 2021, the entire disclosure of which is hereby incorporated by reference in its' entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US22/32115 | 6/3/2022 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63197784 | Jun 2021 | US |
