Finger cuff device with integrated ABSORBeNT pad and lancet guide for capillary sample collection

Abstract

A finger cuff device for use in capillary blood sampling includes a finger cuff having an open end portion sized to receive a user's finger, a finger stop end portion opposite the open end portion, an outer sidewall, and an inner sidewall. The finger cuff also includes at least one lancet guide opening formed through the outer sidewall and the inner sidewall. Additionally, the finger cuff device includes at least one integral absorbent pad disposed on the inner sidewall of the finger cuff.

Description

Technical Field

[0001] The present disclosure relates to a wearable finger cuff device for assisting capillary blood sample collection. More specifically, the present disclosure relates to a patient-wearable finger cuff having a lancet guide opening and an integrated absorbent pad.

[0002] This application claims priority to U.S. Provisional Application No. 63 / 197,784, filed Jun. 7, 2021, entitled “Finger Cuff with Lancet Guide and Integrated Absorbent Pad for Capillary Sample Collection,” the entire disclosure of which is hereby incorporated by reference in its entirety.

Background Art

[0003] Capillary blood sampling is often preferred over venous blood sampling, especially in non-clinical settings and / or applications with small blood volumes. Capillary collection (capillary blood sampling) relies on a lancet (a lancet) to make a small puncture, for example, on the fingertip of a patient, to draw a smaller sample volume compared to venous collection and is generally more comfortable for the patient. Additionally, the absence of a hypodermic needle reduces the risk to the patient and alleviates anxiety. Indeed, since the capillary sampling process is relatively simple, the patient can be instructed to collect the sample themselves, making blood testing more accessible and less expensive.

[0004] However, errors can occur during capillary blood sampling when the sample is taken by a patient or other person without medical training, which can negatively impact the patient experience and sample quality. One such error is the puncture of the patient's finger at a non-ideal location. Generally, finger puncture is recommended to be performed at a location slightly off-center of the finger pad. If the puncture is performed outside this preferred location, the result can be a reduced blood flow from the puncture and / or pain for the patient.

[0005] Another possible error that can occur during capillary collection by the patient or an untrained assistant is that the first drop of blood taken from the finger may enter the sample tube. Typically, this first drop may contain contaminants that could affect the integrity of the sample, so it is recommended to wipe off the first drop of blood with a separate piece of gauze (and therefore not collect it). Furthermore, the first drop of blood may also contain platelet tissue factor, which can undesirably initiate the blood clotting process and interfere with the performance of the analysis. [Overview of the Initiative]

[0006] Therefore, a finger cuff device for use by a patient or an untrained person during capillary blood collection, comprising both a lancet guide opening positioned at the optimal puncture site and an integrated absorbent pad to ensure the removal of the first drop of blood upon removal of the finger cuff device.

[0007] According to one 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 resting end portion opposite the open end portion, an outer side wall, an inner side wall, and at least one lancet guide opening formed through the outer and inner side walls. The finger cuff device also includes at least one integrated absorbent pad positioned on the inner side wall of the finger cuff.

[0008] In certain configurations, at least one lancet guide opening is positioned off-center from the centerline of the finger cuff. In other configurations, at least one lancet guide opening is positioned close to the finger resting end of the finger cuff. In yet another configuration, at least one lancet guide opening is elongated relative to the longitudinal axis of the finger cuff. Optionally, at least one integrated absorbent pad is positioned on the inner sidewall along at least one lancet guide.

[0009] In another configuration, the device includes a pair of openings formed on each side of the finger cuff. Optionally, each opening further comprises a rounded end portion. In certain configurations, the finger cuff is formed of an elastic material.

[0010] According to 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 the user's finger, a finger resting end portion opposite the open end portion, an outer side wall, an inner side wall, at least one lancet guide opening formed through the outer and inner side walls, and at least one integrated absorbent pad positioned on the inner side wall of the finger cuff.

[0011] In certain configurations, at least one lancet guide opening of the finger cuff is positioned off-center from the centerline of the finger cuff. At least one lancet guide opening may be positioned close to the finger resting end portion of the finger cuff. Optionally, at least one lancet guide opening of the finger cuff is elongated with respect to the longitudinal axis of the finger cuff. At least one integrated absorbent pad of the sterile finger cuff device may be positioned on the inner sidewall along at least one lancet guide. In one configuration, the sterile finger cuff device further includes a pair of open end portions formed on each side 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.

[0012] According to another embodiment of the present invention, a method for collecting a capillary blood sample comprises preparing a finger and a desired puncture site for blood sample collection with a sterile wipe, and placing a sterile finger cuff device on the prepared finger at the desired puncture site, the sterile finger cuff device comprising an open end portion sized to accommodate the user's finger, a finger rest end portion opposite the open end portion, an outer side wall, an inner side wall, and at least one lancet guide opening formed through the outer and inner side walls. The method also comprises puncturing the finger at the desired puncture site by pushing a lancet through at least one integrated absorbent pad located on the inner side wall of the finger cuff and at least one lancet guide opening, and removing the sterile finger cuff device from the finger to expose the puncture site and wiping away the first drop of blood from the puncture site via at least one integrated absorbent pad of the sterile finger cuff device.

[0013] In certain configurations, the method also includes collecting a blood sample into a microtainer tube after the initial blood droplet has been wiped away from the puncture site via at least one integrated absorbent pad of the sterile finger cuff device. Optionally, the method further includes closing the microtainer tube after collecting the desired amount of blood sample and bandaging the finger puncture site. In certain configurations, the method also includes positioning the sterile finger cuff device on a prepared finger, including positioning the finger cuff on the finger such that at least one lancet guide opening is positioned off-center from the centerline of the finger.

[0014] Further details and advantages of the present invention will become apparent upon reading the following detailed description in conjunction with the accompanying drawings. Here, similar parts are indicated by the same reference numbers throughout. [Brief explanation of the drawing]

[0015] [Figure 1] Figure 1 is an isometric view of a finger cuff device according to an embodiment of the present disclosure. [Figure 2] Figure 2 is a side cross-sectional view of the finger cuff device shown in Figure 1. [Figure 3A] Figure 3A is an isometric view of the finger cuff device before sampling. [Figure 3B] Figure 3B is an isometric view of the finger cuff device in the sampling state. [Figure 3C] Figure 3C is an isometric view of the finger cuff device after sampling. [Figure 4] Figure 4 is a flowchart of the capillary blood collection method according to the embodiments of this disclosure. [Modes for carrying out the invention]

[0016] The following description is provided to enable those skilled in the art to create and use the described embodiments intended for carrying out the invention. However, various modifications, equivalents, variations, and substitutes will be readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and substitutes are intended to fall within the spirit and scope of this disclosure.

[0017] Hereafter, for illustrative purposes, “top,” “bottom,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “horizontal,” “vertical,” and their derivatives shall be used in relation to the present invention as oriented in the drawings. However, it will be understood that the present invention may presuppose various alternative modifications unless expressly otherwise specified. It should also be understood that the specific devices shown in the accompanying drawings and described in the following specification are merely exemplary embodiments of the present invention. Therefore, specific dimensions and other physical features relating to the embodiments disclosed herein should not be considered limiting.

[0018] Referring to Figures 1 and 2, a finger cuff device 10 according to an aspect of the present disclosure is shown. The finger cuff device 10 includes an outer side wall 12, an inner side wall 14, a finger resting end portion 16, and an open end portion 18. Furthermore, a pair of openings 20 are formed on each side of the finger cuff device 10. Each opening 20 includes a rounded end portion 21, which allows the finger cuff device 10 to expand into the opening 18 to accommodate the user's finger.

[0019] In the embodiments shown in Figures 1 and 2, the finger resting end portion 16 is substantially closed, which prevents the finger cuff device 10 from moving beyond a desired position relative to the user's fingertip. However, it should be understood that the finger resting end portion 16 does not need to be completely or substantially closed and may include one or more openings formed through it. For example, in some embodiments, the finger resting end portion 16 may include one or more narrow material strips that function to provide restriction or restraint to the finger cuff device 10.

[0020] In some embodiments, the finger cuff device 10 is formed of an elastic material, thereby allowing the finger cuff device 10 to deflect when first placed on the user's finger and return to its original position to better hold the finger cuff device 10 in place on the user's finger, for example, without additional fixation via the user's other hand or adhesive such as medical tape. The finger cuff device 10 may be formed of any suitable elastic material that can be sterilized, such as plastic, polymer, or metal. However, it should be understood that other materials, including non-elastic materials, may also be used.

[0021] Referring further to FIGS. 1 and 2, the finger cuff device 10 further includes at least one lancet guide opening portion 22 formed at a position close to the finger stop end portion 16. As shown in FIG. 1, the lancet guide opening portion 22 is disposed slightly off-center from the center of the finger center line A of the finger cuff device 10. In this way, the lancet guide opening portion 22 provides a guide or template for an ideal puncture position, for example, via a lancet (not shown). As described above, the preferred position for capillary blood sampling is a position off-center from the center of the user's finger pad. Thus, the lancet guide opening portion 22 provides a guide for identifying such position(s), while also blocking undesirable positions such as the center of the finger pad and the tip of the finger. Further, since the finger stop end portion 16 restricts the movement of the finger cuff device 10 relative to the fingertip, the lancet guide opening portion 22 is disposed such that the puncture position is sufficiently away from the joint of the user's finger.

[0022] The lancet guide opening portion 22 is sized to sufficiently accommodate at least the penetrating tip of the lancet. In some embodiments, the lancet guide opening portion 22 is elongated to allow the user to select from puncture positions off-center from several centers. The elongated lancet guide opening portion 22 may be beneficial for users performing somewhat frequent blood sampling procedures, as it may allow the user to avoid re-puncturing the same position during each sampling event.

[0023] Further, although not shown in FIGS. 1 and 2, it should be understood that at least one additional lancet guide opening portion 22 may be provided on the opposite side of the finger center line A. In this way, the user may alternately select a preferred puncture position on the off-center finger pad position and / or which side of the finger to use as the puncture site.

[0024] Additionally and / or alternatively, in some embodiments, near or at the lancet guide opening 22, the finger cuff 10 can incorporate a locking mechanism (not shown) that can capture the lancet after finger puncture. The locking mechanism will be configured to prevent removal of the lancet separately from the overall removal of the finger cuff 10. Such a configuration eliminates the need to dispose of the lancet and finger cuff 10 separately and minimizes the number of actions that a user (or another person assisting the user) has to perform before collecting a capillary blood sample. Further, the presence of the locked lancet obliges the user to completely remove the finger cuff 10 to access the puncture site and prevents an attempt to collect blood while the finger cuff 10 remains attached to the user's finger.

[0025] Referring further to FIGS. 1 and 2, the finger cuff 10 further includes an integral sterile absorbent pad 24. In some embodiments, the absorbent pad 24 is disposed on the inner sidewall 14 proximate to the open end portion 18 and substantially in line with the lancet guide opening 22. The absorbent pad 24 can be affixed to the inner sidewall 14 by any suitable means and / or method such as, for example, an adhesive. Further, the absorbent pad 24 can be formed of any suitable absorbent material such as, for example, woven or non-woven cotton gauze, polyester gauze, absorbent paper, and the like.

[0026] As described above, during typical capillary blood collection, it is preferable that the first drop of blood is wiped away by the user via a separate gauze pad before blood collection. This additional step complicates the procedure and can even be completely overlooked, especially if the collection procedure is performed by the patient themselves or another inexperienced user. However, the integrated absorbent pad 24 of the finger cuff 10 prevents such oversights, as the absorbent pad 24 inevitably passes over the puncture site when the finger cuff 10 is removed after puncture, thereby removing the first drop of blood without the need for an additional wiping step. Furthermore, the position of the absorbent pad 24 substantially protects the puncture site from contact with other surfaces of the finger cuff 10 during removal, thus helping to minimize discomfort during the removal of the finger cuff 10.

[0027] It should be understood that, although not shown, two or more absorbent pads 24 may be provided on the inner side wall 14 and / or at other locations on the finger cuff 10. For example, if multiple lancet guide openings 22 are provided on the finger cuff 10, an associated absorbent pad 24 may be provided for each lancet guide opening 22. Additionally and / or alternatively, the size of the absorbent pads 24 is not limited to those shown in Figures 1 and 2. For example, the absorbent pads 24 may be larger or smaller than those shown in Figures 1 and 2.

[0028] Referring here to Figures 3A-3C, the use of the finger cuff 10 on the user's finger 30 according to an aspect of the present disclosure is shown. As shown in Figure 3A, the user first positions the finger cuff 10 on the tip of the selected finger 30 so that the lancet guide opening 22 is exposed to the portion of the finger 30 that is off-center from the center of the pad and defines the desired puncture site. As described above, the finger cuff 10 is preferably held on the finger 30 by the elasticity of the finger cuff 10 itself. However, other means of securing the finger cuff 10, such as adhesive, may also be used.

[0029] Referring to Figure 3B, after the finger cuff 10 is positioned, the user (or another person) uses the lancet 40 to puncture the user's finger 30 at the puncture site 50 within the lancet guide opening 22. Next, as shown in Figure 3C, after confirming that the puncture site 50 has successfully collected blood, the user (or another person) removes the finger cuff 10 from the finger 30 distally away from the user's fingertip. This removal of the finger cuff 10 simultaneously passes the absorbent pad 24 over the puncture site 50, thereby wiping away the first drop of blood from the puncture site 50, which allows the blood sample to be stored for a longer period before testing and / or reduces the possibility of contamination. The user does not need to perform a separate wiping step; for example, collection of a capillary blood sample in a microtainer tube can be started immediately after removal of the finger cuff 10.

[0030] As described above, the finger cuff 10 simplifies the collection of capillary blood samples by the patient themselves and / or other unskilled individuals, ensuring that a suitable puncture site is selected and that the first drop of blood is wiped away before collection. Because the finger cuff 10 incorporates the lancet guide opening 22 and absorbent pad 24 into a single device, it also allows for one-handed collection by the user themselves. Furthermore, the finger cuff 10 poses minimal risk to the patient and / or sample, simply facilitating proper sample collection techniques without affecting sample quality itself.

[0031] In some embodiments, the finger cuff 10 may be provided as part of an overall sample collection provided to the user for capillary blood sample collection at home. The kit may include, for example, a lancet, a microtainer collection tube, at least one sterile wipe, a sterile finger cuff 10, and a bandage for use at the puncture site after collection.

[0032] Next, referring to Figure 4, a method 100 for capillary blood sample collection according to an aspect of the present disclosure is shown. First, in step 102, the user (or another person) selects a desired finger / puncture site and prepares the site for blood sample collection. This preparation may include, for example, washing the puncture site with a sterile wipe. Next, in step 104, a sterile finger cuff, as described above with respect to Figures 1-3C, is placed on the selected finger. In step 106, the lancet is pressed through the lancet guide opening of the finger cuff to puncture the user's finger pad at the selected puncture site, thereby drawing the first drop of blood from the puncture site. The lancet may be held by the user themselves or by another person.

[0033] Next, in step 108, the user (or another person) removes the finger cuff from the finger as described above with respect to Figures 1-3C, simultaneously exposing the puncture site and wiping away the first drop of blood from the puncture site. Once the finger cuff is removed, the user can dispose of the finger cuff and / or lancet in an appropriate container.

[0034] After properly removing the finger cuff and the initial blood droplet, in step 110, the user (or another person) may utilize a suitable capillary collection microtainer tube to obtain the required sample volume. Then, when the required sample volume has been collected, in step 112, the user (or another person) may close the microtainer tube with a suitable cap or lid and bandage the puncture site on the user's finger.

[0035] Using Method 100, a capillary blood sample can be obtained from a puncture site off-center from the user's finger, minimizing the chance of user error. Furthermore, since the absorbent pad is integrated within the finger cuff, the initial blood droplet is wiped away from the puncture site simultaneously with the removal of the finger cuff. In this way, Method 100 avoids the extra wiping step, which is cumbersome for the user obtaining their sample and is often overlooked or completely skipped.

[0036] While several embodiments of a finger cuff with a lancet guide and an integrated absorbent pad (and their use in capillary blood sampling) are described in the detailed description above, those skilled in the art can modify and alter these embodiments without departing from the scope and spirit of the invention. Therefore, the description above is intended to be illustrative rather than restrictive. The invention as described above is defined by the appended claims, and all modifications to the invention that fall within the meaning and equivalence of the claims are encompassed within those scopes.

Claims

1. A finger cuff device for use in collecting capillary blood samples, It is a finger cuff, An open end portion sized to accommodate the user's fingers, The finger resting end portion opposite to the aforementioned open end portion, outer side wall, Inner side wall, and an opening in at least one lancet guide formed through the outer and inner side walls. A finger cuff equipped with, At least one integrated absorbent pad disposed on the inner side wall of the finger cuff, Includes, A finger cuff device wherein the at least one lancet guide opening is positioned off-center from the centerline of the finger cuff and close to the finger resting end portion of the finger cuff.

2. The finger cuff device according to claim 1, wherein the at least one lancet guide opening is elongated with respect to the longitudinal axis of the finger cuff.

3. The finger cuff device according to claim 1, wherein the at least one integrated absorbent pad is positioned on the inner side wall along the at least one lancet guide.

4. The finger cuff device according to claim 1, further comprising a pair of openings formed on each side of the finger cuff.

5. The finger cuff device according to claim 4, wherein each opening portion further comprises a rounded end portion.

6. The finger cuff device according to claim 1, wherein the finger cuff is formed of an elastic material.

7. A kit for collecting capillary blood samples, Lancet and, Microtainer collection tube, At least one sterile wipe, Bandages and, A sterile finger cuff device, It is a finger cuff, An open end portion sized to accommodate the user's fingers, The finger-stopping end portion opposite to the aforementioned open end portion, outer side wall, Inner side wall, and an opening in at least one lancet guide formed through the outer and inner side walls. A finger cuff, Furthermore, at least one integrated absorbent pad is disposed on the inner side wall of the finger cuff, A sterile finger cuff device equipped with, Includes, The kit is configured such that the at least one lancet guide opening is positioned off-center from the centerline of the finger cuff and close to the finger resting end portion of the finger cuff.

8. The kit according to claim 7, wherein the at least one lancet guide opening of the finger cuff is elongated with respect to the longitudinal axis of the finger cuff.

9. The kit according to claim 7, wherein the at least one integrated absorbent pad of the sterile finger cuff device is positioned on the inner side wall along the at least one lancet guide.

10. The kit according to claim 7, wherein the sterile finger cuff device further comprises a pair of openings formed on each side of the finger cuff.

11. The kit according to claim 10, wherein each opening portion of the finger cuff further comprises a rounded end portion.

12. The kit according to claim 7, wherein the finger cuff is formed of an elastic material.

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