BLOOD COLLECTION DEVICE INCLUDING PAIN REDUCTION FEATURES - Patent application

Abstract

A device for obtaining a blood sample, the device including a holder for receiving a sample source, the holder having an actuation portion and a port, a container engaging portion connected to the holder, and a pain-relieving member provided on an inner surface of the holder.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 419,123, filed October 25, 2022, entitled "Blood Collection Device Including Pain Relief Features," the entire disclosure of which is incorporated herein by reference in its entirety. [Background technology]

[0002] Background of the Invention FIELD OF THE INVENTION The present disclosure relates generally to devices for obtaining biological samples. More particularly, the present disclosure relates to a finger-based capillary blood collection device that may be provided with features to provide comfort to a patient's finger during use of the blood collection device.

[0003] 2. Description of Related Art Devices for obtaining and collecting biological samples, such as blood samples, are commonly used in the medical industry. One type of blood collection commonly performed in the medical field is capillary blood collection, which is often performed to collect blood samples for testing. Certain diseases, such as diabetes, require periodic testing of a patient's blood to monitor the patient's blood glucose levels, etc. Additionally, test kits, such as cholesterol test kits, often require blood samples for analysis. Blood collection procedures typically involve pricking a finger or other suitable body site to obtain a blood sample. Typically, the amount of blood required for such tests is relatively small, and a small puncture or incision typically provides a sufficient volume of blood. Various types of lancet devices have been developed and are used to puncture a patient's skin to obtain a capillary blood sample from the patient.

[0004] Many different types of lancet devices are commercially available to hospitals, clinics, doctors' offices, and individual consumers. Such devices generally include a sharp-tipped member, such as a needle, or a sharp-tipped member, such as a blade, and are used to quickly puncture or incise a patient's skin to provide a small amount of blood. To simplify capillary blood collection, lancet devices have evolved into automatic devices that puncture or incise a patient's skin upon activation of a trigger mechanism. In some devices, the needle or blade remains in a standby position until triggered by the user. When triggered, the needle or blade punctures or cuts the patient's skin, e.g., a finger. Often, a spring is incorporated into the device to provide the "automatic" force necessary to puncture or cut the patient's skin.

[0005] One type of contact-activated lancet device featuring automatic ejection and retraction of a puncturing or cutting element from and into the device is U.S. Pat. No. 9,380,975, owned by Becton, Dickinson & Company, the assignee of the present application. This lancet device includes a housing and a lancet structure having a puncturing element. The lancet structure is disposed within the housing and adapted for movement between a retained or pre-actuated position, in which the puncturing element is retained within the housing, and a puncturing position, in which the puncturing element extends through the forward end of the housing. The lancet device includes a drive spring disposed within the housing to bias the lancet structure toward the puncturing position, and a retention hub that holds the lancet structure in a retracted position against the biasing force of the drive spring. The retention hub includes a pivot lever that interference-engages with the lancet structure. An actuator within the housing pivots the lever, thereby moving the lancet structure toward the rearward end of the housing and at least partially compressing the drive spring, releasing the lever from interference engagement with the lancet structure. The received blood sample is then collected and / or tested. This testing can be performed by a point-of-care (POC) testing device, or it can be collected and sent to a testing facility.

[0006] The use of a lancet device for capillary blood collection can be complex, requiring a high level of skill from the healthcare professional performing the blood collection procedure. The multi-step nature of the capillary blood collection process can introduce several variables that can cause sample quality issues, such as hemolysis, insufficient sample stabilization, and microthrombi. The use of a lancet device to obtain a blood sample can result in several variables that affect the collection of a capillary blood sample, including, but not limited to, keeping the lancet stationary during testing, obtaining sufficient blood flow from the puncture site, properly collecting blood, preventing clotting, etc. The most common sources of process variability include: (1) inadequate incision site cleaning and initial droplet removal, potentially resulting in a contaminated sample; (2) inconsistent incision location and depth, potentially resulting in insufficient sample volume and excessive interstitial fluid; (3) inconsistent squeezing technique and excessive pressure near the incision site, promoting blood extraction (e.g., blood expression), which can potentially result in hemolysis; (4) variable transfer interface and collection technique, potentially resulting in hemolysis or a contaminated sample; and (5) inadequate sample mixing with anticoagulant, potentially resulting in microthrombi.

[0007] The general population has a wide variety of finger sizes. A patient's finger may be sized between two different sizes for a blood collection device, or the patient's finger may be too small or too large for a particular blood collection device. While capillary blood collection devices and assemblies have been developed to simplify the capillary blood collection process, such as finger-based capillary blood collection devices configured to lancet and compress the finger to collect, stabilize, and dispense a blood sample in a controlled manner, problems related to blood sample quality can still occur. Attempting to perform a blood collection procedure using a device that is not correctly sized for the patient's finger can exacerbate such blood sample quality issues and cause discomfort to the patient's finger. For example, an incorrectly sized blood collection device may apply pressure to the patient's finger in an incorrect or inconsistent manner, resulting in poor blood flow from the punctured finger and pain and soreness in the patient's finger. The blood collection devices and methods disclosed herein are configured to improve patient comfort with the blood collection device and improve blood sample quality. Summary of the Invention

[0008] In one non-limiting embodiment or aspect of the present disclosure, an apparatus for obtaining a blood sample may include a holder for receiving a sample source, the holder having an actuation portion and a port, a container engaging portion connected to the holder, and a pain-relieving member provided on an inner surface of the holder.

[0009] In one non-limiting embodiment or aspect of the present disclosure, the pain relief member may include at least one elastomeric material positioned on an inner surface of the holder. The pain relief member may be positioned on an inner surface of the working portion of the holder. The at least one elastomeric material may be positioned to contact a dorsal portion of the sample source held in the holder. The pain relief member may include a ring configured to cover an outer peripheral surface of the sample source. The ring may be made of an elastomeric material. The ring may include a plurality of ribs or bumps on its outer surface for gripping the holder. The sample source may be a finger. The finger may be received within the holder, and the port may be in communication with a portion of the finger. The working portion may include a pair of opposing wings configured to be pumped to collect a blood sample from the sample source.

[0010] In one non-limiting embodiment or aspect of the present disclosure, an apparatus for obtaining a blood sample may include a holder for receiving a sample source, the holder having an actuation portion and a port, a container engaging portion connected to the holder, and a clamping device provided on the holder for adjusting the diameter of the holder receiving the sample source.

[0011] In one non-limiting embodiment or aspect of the present disclosure, the clamping device may include a zip tie to reduce the diameter of the holder and clamp the holder to the sample source. The zip tie may include a zip tie strap on a first portion of the holder and a zip tie opening on a second portion of the holder. The clamping device may be located on a bottom surface of the holder. The sample source may be a finger. When the finger is received in the holder, the port may be in communication with a portion of the finger. The actuating portion may include a pair of opposing wings configured to be pumped to collect a blood sample from the sample source. The actuating portion may include a pump member for applying pressure to the sample source.

[0012] In one non-limiting embodiment or aspect of the present disclosure, a kit for use in obtaining a blood sample may include: a blood collection device with a holder for receiving a sample source, the holder having an actuation portion and a port; a container engagement portion connected to the holder; and a pain relief member separate from the blood collection device, the pain relief member configured to minimize or eliminate pain experienced by the sample source held in the holder. The pain relief member may include an elastomeric ring configured to surround an outer circumferential surface of the sample source.

[0013] The present invention is also disclosed in the following clauses.

[0014] Clause 1: A device for obtaining a blood sample, the device comprising: a holder for receiving a sample source, the holder having an actuation portion and a port; a container engaging portion connected to the holder; and a pain-relieving member provided on an inner surface of the holder.

[0015] Clause 2: The device of clause 1, wherein the pain relief member includes at least one elastomeric material positioned on an inner surface of the holder.

[0016] Clause 3: The device of clause 1 or clause 2, wherein the pain relief member is positioned on an inner surface of the working portion of the holder.

[0017] Clause 4: The apparatus of clause 2, wherein the at least one elastomeric material is positioned to contact a back portion of the sample source held in the holder.

[0018] Clause 5: The device of any of clauses 1-4, wherein the pain relief member comprises a ring configured to cover an outer peripheral surface of the sample source.

[0019] Clause 6: The device of clause 5, wherein the ring is made of an elastomeric material.

[0020] Clause 7: The apparatus of clause 5 or clause 6, wherein the ring includes a plurality of ribs or bumps on its outer surface to grip the holder.

[0021] Clause 8: The apparatus of any of clauses 1 to 7, wherein the sample source is a finger.

[0022] Clause 9: The device of clause 8, wherein the port communicates with a portion of the finger when the finger is received within the holder.

[0023] Clause 10: The device of any of clauses 1 to 9, wherein the actuating portion comprises a pair of opposing wings configured to be pumped to aspirate a blood sample from the sample source.

[0024] Clause 11: An apparatus for obtaining a blood sample, the apparatus comprising: a holder for receiving a sample source, the holder having an actuation portion and a port; a container engaging portion connected to the holder; and a clamping device provided on the holder for adjusting the diameter of the holder for receiving the sample source.

[0025] Clause 12: The apparatus of clause 11, wherein the fastening device includes a zip tie for reducing the diameter of the holder to fasten the holder to the sample source.

[0026] Clause 13: The apparatus of clause 12, wherein the zip tie includes a zip tie strap on the first portion of the holder and a zip tie opening in the second portion of the holder.

[0027] Clause 14: The device of any one of clauses 11 to 13, wherein the clamping device is provided on a bottom surface of the holder.

[0028] Clause 15: The apparatus of any of clauses 11 to 14, wherein the sample source is a finger.

[0029] Clause 16: The device of clause 15, wherein the port is in communication with a portion of the finger when the finger is received within the holder.

[0030] Clause 17: The device of any of clauses 11 to 16, wherein the actuating portion comprises a pair of opposing blades configured to be pumped to aspirate a blood sample from the sample source.

[0031] Clause 18: The apparatus of any of clauses 11 to 17, wherein the actuating portion includes a pump member for applying pressure to the sample source.

[0032] Clause 19: A kit for use in obtaining a blood sample, the kit comprising: a blood collection device comprising a holder for receiving a sample source, the holder having an actuation portion and a port, and a container engaging portion connected to the holder; and a pain relief member provided separately from the blood collection device, the pain relief member configured to minimize or eliminate pain experienced from the sample source held in the holder.

[0033] Clause 20: The kit of clause 19, wherein the pain relief member comprises an elastomeric ring configured to surround an outer peripheral surface of the sample source. [Brief explanation of the drawings]

[0034] [Figure 1A] FIG. 1A is a perspective view of a capillary blood collection device and collection container for obtaining a blood sample from a patient's finger according to one embodiment of the present disclosure. [Figure 1B] FIG. 1B is a cross-sectional view of a capillary blood collection device and a lancet according to one embodiment of the present disclosure. [Figure 1C] FIG. 1C is a perspective view of a holder for a capillary blood collection device according to one embodiment of the present disclosure. [Figure 1D] FIG. 1D is a schematic diagram showing the top view of the holder of FIG. 1C connected to a patient's finger to perform a blood collection procedure. [Figure 1E] FIG. 1E is another schematic diagram showing the front of the holder of FIG. 1C connected to a patient's finger. [Figure 2] FIG. 2 is a front view of a capillary blood collection device including a pain relief feature according to one embodiment of the present disclosure. [Figure 3] FIG. 3 is a front view of a capillary blood collection device including a finger cuff and an assembly of different finger cuff sizes according to one embodiment of the present disclosure. [Figure 4] FIG. 4 is a front view of a capillary blood collection device including a fastening feature according to one embodiment of the present disclosure. [Figure 5] FIG. 5 is a perspective view of a capillary blood collection device including a fastening feature according to an embodiment of the present disclosure. [Figure 6] FIG. 6 is a diagram of a capillary blood collection device including a fastening feature, according to an embodiment of the present disclosure. [Figure 7] FIG. 7 is a diagram of a capillary blood collection device including a fastening feature according to one embodiment of the present disclosure. [Figure 8] FIG. 8 is a diagram of a capillary blood collection device including a fastening feature according to one embodiment of the present disclosure. [Figure 9A] FIG. 9A is a diagram of a capillary blood collection device including a fastening feature, according to one embodiment of the present disclosure. [Figure 9B] FIG. 9B is a diagram of a capillary blood collection device including a fastening feature, according to one embodiment of the present disclosure. [Figure 10] FIG. 10 is a diagram of a capillary blood collection device including a fastening feature according to one embodiment of the present disclosure. [Figure 11] FIG. 11 is a diagram of a capillary blood collection device including a fastening feature according to one embodiment of the present disclosure. [Figure 12] FIG. 12 is a diagram of a capillary blood collection device including a fastening feature, according to one embodiment of the present disclosure. [Figure 13] FIG. 13 is a diagram of a capillary blood collection device including a fastening feature, according to one embodiment of the present disclosure. [Figure 14] FIG. 14 is a diagram of a capillary blood collection device including a fastening feature, according to one embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0035] Description of the Disclosure The following description is provided to enable any person skilled in the art to make and use the described embodiments contemplated for practicing the invention. However, various modifications, equivalents, variations, and alternatives will remain readily apparent to those skilled in the art. All such modifications, variations, equivalents, and alternatives are intended to be within the spirit and scope of the invention.

[0036] For purposes of the following description, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "lateral," "longitudinal," and their derivatives refer to the present invention as oriented in the drawing figures. However, it should be understood that the present invention may contemplate alternative variations and step sequences, unless expressly specified to the contrary. It should also be understood that the specific devices and processes illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of the present invention. Accordingly, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered limiting.

[0037] The present disclosure is directed to a blood collection device 10 (shown in FIGS. 1A-1E) that includes a pain-reducing feature that helps relieve pain in a patient's finger during use of the blood collection device 10. As will be appreciated by those skilled in the art, with many products, such as clothing, that vary in size, there is generally no safety concern in having multiple people try them on to ensure fit. Furthermore, if there are concerns about proper sizing, the user or wearer can discard the product rather than continue using an improperly sized product. However, with medical devices, such as the blood collection device 10, there may be safety concerns in using an improperly sized device 10 on a patient's finger. Furthermore, discarding a medical device, such as the blood collection device 10, because the device is not the proper size for a particular patient is inefficient and increases the cost of such devices and medical procedures using the device 10. The devices, systems, and methods disclosed herein are intended to improve the comfort of use of the blood collection device 10 and help ensure that the blood collection device 10 used for each patient is comfortable, regardless of the patient's finger size.

[0038] According to one aspect, the present disclosure relates to a method for designing and / or manufacturing a capillary blood collection device 10 that includes a finger cuff or holder 12 that includes features that reduce or eliminate pain caused or resulting from using the blood collection device 10 on a patient's finger. For example, if the holder 12 or finger cuff is too loose, the holder 12 or cuff may shift or fall off during the blood collection procedure. If the holder 12 or finger cuff is too tight, the device 10 may restrict blood flow or cause pain to the patient. During pumping of the blood collection device 10, a portion of the blood collection device 10 may contact and compress the patient's finger. Each of these situations can cause pain or discomfort to the patient's finger during use of the blood collection device 10.

[0039] Blood collection device An example of a blood collection device 10 having dimensions that can be optimized to properly fit a patient within a defined dimensional range is shown in Figures 1A-1E. Blood collection device 10 can be a self-contained, fully integrated, finger-based capillary blood collection device capable of lancing, collecting, and stabilizing large volume capillary blood samples, for example, up to 500 microliters or more. Blood collection device 10 can also be a device formed from separable components (i.e., finger cuff or holder 12, lance, and sample container) that can be connected and / or used together to obtain a blood sample. Some additional exemplary capillary blood collection devices and assemblies that can be modified for use with the systems and methods of the present disclosure are described in U.S. Patent Application Publication No. 2019 / 0216380, entitled "Device for Obtaining a Blood Sample," U.S. Patent Application Publication No. 2019 / 0223772, entitled "Device for Obtaining a Blood Sample," and International Publication No. WO 2020 / 167746, entitled "Capillary Collector with Rotatable Connection," each of which is incorporated herein by reference in its entirety.

[0040] 1A and 1B, an exemplary blood collection device 10 includes an integrated holder 12 (also referred to herein as a finger cuff), a lancet housing or lancet 14 (shown in FIG. 1B) for lancing a patient's finger 19 (shown in FIGS. 1D and 1E), and a collection reservoir 16 (shown in FIG. 1A). In other examples, blood collection device 10 may be provided as a semi-integrated device 10, including, for example, an integrated lancet housing 14 and collection reservoir 16 that may be connected to a separate holder 12. In other examples, a semi-integrated device may have an in-line flow and an integrated lancet housing and collection reservoir that may be connected to a separate holder.

[0041] Holder 12 is configured to receive a sample source, e.g., a patient's finger 19, to provide a biological sample, such as a blood sample. As shown in FIGS. 1C-1E, holder 12 generally includes a finger-receiving portion 20 having a first opening 22, an actuation portion 24, a port 26 having a second opening 28, and a finger end guard 30. First opening 22 can have a width W1 (shown in FIGS. 1D and 1E), which corresponds to the maximum finger width of a finger 19 that can be used with device 10. First opening 22 can also have a height H1 (shown in FIG. 1E), which corresponds to the maximum finger height of a finger 19 that can be used with device 10. Finger-receiving portion 20 can also have a length L1 (shown in FIG. 1D), which corresponds to the maximum finger length of a finger 19 that can be used with device 10 (i.e., the finger length from the fingertip to the second knuckle). If the patient's finger 19 is larger than width W1, height H1, and / or length L1, a different sized blood collection device 10 and / or holder 12 should be used for that patient.

[0042] The finger end guard 30 is configured to provide a stop for properly aligning and securing the finger 19 within the holder 12. The finger end guard 30 further helps ensure that the patient's finger 19 is properly positioned within the finger receiving portion 20 so that pressure applied to the patient's finger 19 results in proper blood flow. The finger end guard 30 may have a curved fingertip rest that ensures that the patient's finger 19 rests securely at the end of the finger receiving portion 20 while allowing the patient's fingernail to clear the end of the finger receiving portion 20. The finger receiving portion 20 allows the holder 12 to be used with artificial and natural fingernail styles present in the patient population.

[0043] First opening 22, having a width W1 and a height H1, is configured to receive a sample source, e.g., a finger 19. Sample sources may also include other body parts, such as a toe or other extremity, that can fit within first opening 22. Port 26 is in communication with finger-receiving portion 20. For example, when finger 19 is received within holder 12, port 26 is in communication with a portion of finger 19. As described in further detail herein, holder 12 may be sized for use with specific subsets of patients. For example, small holder 12 may be appropriately sized for the lower quartile of patients. Medium and large holders 12 may be sized for use with patients in the middle lower quartile of patients (25%-50%) and the middle upper quartile of patients (50%-75%), respectively.

[0044] A second opening 28 of the port 26 is configured to receive the lancet housing or lancet 14 (shown in FIG. 1B) and the collection container 16 (shown in FIG. 1A). In some examples, the port 26 further includes a locking portion 32 for securely receiving the lancet housing or lancet 14 and the collection container 16 within the port 26.

[0045] The actuating portion 24 of the device 10 is movable between a first position in which the holder 12 defines a first diameter and a second position in which the holder 12 defines a second diameter, the second diameter being smaller than the first diameter. Furthermore, in the first position, the holder 12 defines a first elliptical shape or cross-section. In the second position, the holder 12 defines a second elliptical shape or cross-section, the first elliptical shape or cross-section being different from the second elliptical shape or cross-section. In this manner, with the holder 12 having the reduced diameter in the second position, a portion of the holder 12 contacts the sample source (i.e., the finger 19), and the actuating portion 24 of the holder 12 can pump and / or extract blood, as described in more detail below.

[0046] In some examples, the actuating portion 24 includes a contact member 34. When the actuating portion 24 is in a first position, the contact member 34 is in a disengaged position, i.e., the contact member 34 is disposed at a first position relative to the sample source such that the contact member 34 may make slight contact therewith. When the actuating portion 24 is in a second position, the contact member 34 is in an engaged position, i.e., the contact member 34 is disposed at a second position relative to the finger 19 such that the contact member 34 makes pressure contact with the finger 19, allowing the actuating portion 24 of the holder 12 to pump and / or extract blood. For example, when the contact member 34 is in the engaged position, the contact member 34 exerts pressure on the sample source.

[0047] In some embodiments, the actuation portion 24 includes a pumping member 36 for applying pressure to the finger 19, such as a pair of opposing tabs or wings 38. Each wing 38 can include a contact member 34. The holder 12 can also include a living hinge portion 42. The living hinge portion 42 allows a user to squeeze the wings 38 between a first position (passive state) and a second position (active state). Using the tabs or wings 38 to draw blood from the patient's finger 19 is believed to minimize hemolysis while maintaining adequate blood flow from the patient's finger 19. The resting position and hinge of the wings 38 are designed to maintain contact and retention with the smallest patient's finger that can fit into the holder 12, while flexing to accommodate the largest patient's finger within the holder 12 without blood blockage. In some examples, the wings 38 can be positioned on the finger-receiving portion 20 at the proximal end of the patient's nail and distal to the patient's first joint to avoid hard tissue on the patient's finger 19.

[0048] Holder 12 may be configured to allow a user to repeatedly squeeze and release wings 38 to pump and / or extract blood from finger 19 until a desired amount of blood fills collection container 16. Wings 38 are configured to maintain gentle contact with a range of patient finger sizes that may be used with holder 12 and to flex to hold holder 12 on patient's finger 19. Wings 38 may also provide an active pressure function for holder 12.

[0049] In some embodiments, holder 12 can include a stability extension 40, which provides additional support for securely placing holder 12 on finger 19. In one embodiment, finger receiving portion 20 generally forms a C-shaped member and includes a plurality of inner gripping members for providing additional grip and support for securely placing holder 12 on finger 19. Stability extension 40 helps to maintain contact with the patient's finger 19 during use of holder 12 while avoiding the patient's finger's blood supply and knuckles.

[0050] The blood collection device 10 for obtaining a blood sample also includes a lancet housing or lancet 14 (shown in FIG. 1B) removably connectable to the port 26 of the holder 12. Referring to FIG. 1B, the lancet housing or lancet 14 may include an entrance or opening 50, an interior 52, a puncturing element 54, an engagement portion 56, a retractable mechanism 58, and a drive spring 60. The puncturing element 54 may be movable between a pre-actuated position in which the puncturing element 54 is retained within the interior 52 of the lancet housing 14 and a puncturing position in which at least a portion of the puncturing element 54 extends through the entrance 50 of the lancet housing or lancet 14 to incise a portion of the finger 19. In one example, the lancet 14 of the present disclosure is a contact-activated lancet and may be configured according to the features disclosed in U.S. Pat. No. 9,380,975, entitled "Contact-Activated Lancet Device," which is incorporated herein by reference in its entirety.

[0051] In some examples, the holder 12 and the lancet housing or lancet 14 are separate components that are removably connectable to the port 26 of the holder 12. In such examples, the lancet housing or lancet 14 includes an engagement portion 56. The lancet housing or lancet 14 can be pressed into the port 26 of the holder 12 such that the engagement portion 56 of the lancet housing or lancet 14 locks into the locking portion 32 of the holder 12. In this manner, the lancet housing 14 is securely coupled and locked to the holder 12 such that the puncturing element 54 of the lancet housing 14 can be actuated to lance or lance the sample source, e.g., the finger 19. In some examples, the port 26 of the holder 12 includes a plurality of ribs for securely locking the lancet 14 or collection container 16 within the port 26.

[0052] To activate the lancet 14, the lancet 14 is pressed against the finger 19, activating the retractable mechanism 58 and drive spring 60 of the lancet 14 and lancing the finger 19. After lancing, the lancing element 54 is immediately retracted and safely secured within the interior 52 of the lancet housing 14. Once the finger 19 is punctured, a blood sample is expressed from the finger 19 into the collection container 16. The collection container 16 may also include a sample stabilizer, such as an anticoagulant, to stabilize the blood sample and / or components of the blood sample disposed therein. The collection container 16 may also include at least one fill line(s) corresponding to a predetermined volume of sample. The collection container 16 may also indicate / measure the amount of blood collected.

[0053] 1A-1E, the desired finger 19 is first cleaned, and a holder 12 having dimensions appropriate for the desired finger 19 is selected and securely placed on the finger 19. Next, a lancet housing or lancet 14 is connected to port 26 of holder 12. As previously described, the lancet housing or lancet 14 is pressed into port 26 of holder 12 so that engagement portion 56 of the lancet housing or lancet 14 locks into locking portion 32 of holder 12. In this manner, the lancet housing or lancet 14 is securely coupled and locked to holder 12 so that the puncturing element 54 of the lancet housing 14 can be actuated to incise or puncture the finger 19. With the lancet 14 connected to port 26 of holder 12, the lancet 14 is in communication with the finger 19.

[0054] When it is desired to actuate the lancet 14 to lancing the skin of the finger 19, the lancet 14 is pressed against the finger 19, activating the retractable mechanism 58 of the lancet 14 to lancing the finger 19. After the finger 19 has been lancing to induce blood flow from the finger 19, the lancet 14 is removed from the holder 12 and the collection container 16 is pushed into the port 26 of the holder 12. With the container 16 properly secured in the holder 12 for collection of a blood sample, the user repeatedly squeezes and releases the wings 38 of the holder 12 to draw and / or extract blood from the finger 19 until a desired amount of blood is collected in the collection container 16. Advantageously, with the holder 12 placed on the finger 19, the holder 12 does not restrict blood flow and defines the lancing and finger squeezing position. The squeeze tabs or wings 38 provide a predefined range of squeeze pressure that is consistently applied across the finger 19. In doing so, the holder 12 provides a gentle, controlled finger massage that stimulates blood extraction and minimizes potential hemolysis.

[0055] Once a desired amount of blood has been collected in the container 16, the blood collector portion, including the collection container 16, can be disconnected from the collection device 10 for purposes of sending the collected sample to diagnostic and / or testing equipment. The blood collection portion can be sealed via a cap or septum once removed from the blood collection device 10 to protectively seal the blood sample within the blood collection container 16.

[0056] Pain relief or elimination function Due to the contact of the wings 38 against the patient's finger, the patient may experience pain or discomfort on the dorsal surface of the finger due to the constant contact from the wings 38. It is also contemplated that the patient may experience pain or discomfort on the bottom surface of the finger due to the pressure of the wings 38 pressing the patient's finger into the holder 12. Referring to FIG. 2 , according to one aspect or embodiment of the present disclosure, the blood collection device 10 may include at least one pain relief member 100A, 100B to reduce or eliminate pain or discomfort experienced by the patient when using the blood collection device 10. In one example, the pain relief members 100A, 100B may be positioned on an inner surface of the blood collection device 10 such that they contact the patient's finger 19 when held in the blood collection device 10, with at least a portion of the pain relief member 100A, 100B positioned on the wings 38 and at least a portion of the pain relief member 100A, 100B positioned on the holder 12. In another example, pain relief members 100A, 100B may be positioned on the entire inner surface of wings 38 and holder 12 to contact all portions of the patient's finger 19 that contact the blood collection device 10. In one example, blood collection device 10 may include a first pain relief member 100A positioned on a first wing 38 and a second pain relief member 100B positioned on a second wing 38, with pain relief members 100A, 100B positioned to contact opposing sides of the patient's finger 19.

[0057] The pain relief members 100A, 100B may be made of an elastomeric material that provides a cushion for the patient's finger 19 to rest against when the wings 38 are being pumped. In one example, the pain relief members 100A, 100B may be elastomeric pads, patches, or strips that are removably attached to the inner surfaces of the wings 38 and holder 12. The pain relief members 100A, 100B may also be permanently secured to the wings 38 and holder 12 using adhesives, by welding, or other similar connecting methods. In another example, the pain relief members 100A, 100B may be integrally formed with the wings 38 and holder 12. The pain relief members 100A, 100B may be configured to absorb concentrated stress from the wings 38 and minimize or eliminate pain experienced by the patient. The pain relief members 100A, 100B may be configured to reduce stress and pain on the dorsal or upper portions of the patient's finger 19.

[0058] Referring to FIG. 3 , according to a non-limiting embodiment or example of the present disclosure, the blood collection device 10 may include a pain relief member 102, which may be configured to reduce or eliminate pain on the patient's finger 19 due to the patient's finger 19 being too small for the size of the blood collection device 10 to be used by the patient. The pain relief member 102 may be used when the patient's finger 19 is not the recommended size for the particular blood collection device 10 to be used by the patient. In one example, the pain relief member 102 may be an elastomeric sleeve or ring that is placed on the patient's finger 19 and acts as a cushion between the patient's finger 19 and the holder 12. The pain relief member 102 may be used for a patient's finger 19 that is between sizes for the blood collection device 10 or that is too small to fit into the small cuff size for the blood collection device 10. The pain relief member 102 may be ring-shaped and cover the entire circumference of the patient's finger 19. In one example, the pain relief member 102 may be configured to reduce or eliminate pain on the dorsal or upper portion of the patient's finger 19. The pain relief member 102 may also include ribs or bumps on its outer surface to assist the patient's fingers 19 in gripping the blood collection device 10 when positioned in the holder 12. In another example, a kit may be provided with the blood collection device 10 and, separately, the pain relief member 102.

[0059] Referring to FIG. 4 , according to a non-limiting embodiment or example of the present disclosure, the blood collection device 10 may include a clamping device 104, which may help reduce or eliminate pain in the patient's finger 19 during use of the blood collection device 10. The clamping device 104 may be configured to clamp the holder 12 when the patient's finger 19 is positioned within the holder 12. Clamping the holder 12 around the patient's finger 19 reduces pressure from the wings 38 and portions of the holder 12 when the blood collection device 10 is in use. Because the wings 38 do not need to press inward only when the holder 12 is not clamped against the patient's finger 19, less force is required to press against the patient's finger 19, thereby reducing or eliminating pain in the patient's finger 19. The clamping device 104 may be used when the patient's finger 19 is too small for the blood collection device 10 being used by the patient. In one example, by clamping the holder 12, the diameter of the holder 12 is reduced to accommodate the smaller patient's finger 19. The fastening device 104 may include a zip tie mechanism including a zip tie strip 106 and a zip tie opening 108 that receives the zip tie strip 106. The zip tie strip 106 can be pulled through the zip tie opening 108 to fasten the holder 12 to the patient's finger 19. In another example, instead of a zip tie mechanism, the holder 12 can include a hook and loop strip to fasten the holder 12 to the patient's finger 19. By using the fastening device 104 with the blood collection device 10, the blood collection device 10 can be adjusted to fit any size patient's finger 19, thus eliminating the need to customize the blood collection device 10 to fit a specific patient's finger.

[0060] 5 and 6 , according to one non-limiting embodiment or aspect of the present disclosure, the blood collection device 10 can include a squeeze limiting element 110 to limit the amount or distance the wings 38 of the blood collection device 10 are squeezed, thereby reducing pain experienced by a patient when the wings 38 are over-squeezed. The squeeze limiting element 110 can be attached to any inner surface of the wings 38 so that as the wings 38 are squeezed, opposing elements of the squeeze limiting element 110 abut against each other if the wings 38 are over-squeezed, thereby preventing the wings 38 from further closing against the patient's finger 19. As shown in FIG. 6 , the squeeze limiting element 110 can also be rotated downward to create added pressure against the patient's finger 19 held in the holder 12 and reduce pain caused by the wings 38 against the dorsal portion of the patient's finger 19. The squeeze limiting element 110 can be attached to the wings 38 via a living hinge. The blood collection device can also include a rear gripper 112 attached to the holder 12 via a living hinge 114. The living hinge 114 allows the rear gripper 112 to be rotated from a downward position to an upward position in which the rear gripper 112 receives the holder 12 over it.

[0061] 7 , according to one non-limiting embodiment or aspect of the present disclosure, the holder 12 may be designed with a plurality of differently sized finger holding grooves 116 to accommodate multiple sizes of patient fingers. In particular, the top portion of the holder 12 may include the largest of the finger holding grooves 116, and the bottom portion of the holder 12 may include the smallest of the finger holding grooves 116. When using the blood collection device 10, the patient may insert their finger into the holder 12 and move their finger down along the finger holding groove 116 until they find a finger holding groove 116 that is comfortable for them to place their finger in. Ensuring that the patient uses an appropriately sized finger holding groove 116 reduces or eliminates any pain experienced by the patient.

[0062] Referring to FIG. 8 , according to one non-limiting embodiment or aspect of the present disclosure, the holder 12 may be designed with wings 118 that are designed and configured to be biased toward a closed position. In this manner, the wings 118 are opened in the reverse order of the wings 38 described above, which are squeezed into the closed position. The wings 118 shown in FIG. 8 are configured to rest in a closed position and can be squeezed to open and receive a patient's finger. Once the wings 118 are released, they close and rest against the patient's finger, thereby allowing a number of different sizes of patient's fingers to be used with the blood collection device 10. To open the wings 118, a user grasps the outer surfaces of the wings 118 and squeezes the wings 118 toward each other, thereby expanding the channel defined by the wings 118 to receive the patient's finger.

[0063] 9, according to one non-limiting embodiment or aspect of the present disclosure, the holder 12 may be designed with wings 120 that include cutouts 122 to accommodate different sizes of patient's fingers. In this configuration, inner wings 124 may be used to accommodate smaller sized patient's fingers, thereby ensuring that the wings 120 and holder 12 rest comfortably against the patient's finger when using the blood collection device 10. As also shown in FIG. 9, hinges 126 for the inner wings 124 may be adjusted based on the size of the patient's finger.

[0064] 10 , according to one non-limiting embodiment or aspect of the present disclosure, the holder 12 may include an inflatable pad 128 positioned on a bottom surface of the holder 12. The inflatable pad 128 may be inflated or deflated to reduce the inner diameter of a channel defined by the holder 12, thereby allowing patient fingers of different sizes to be accommodated within the holder 12. The inflatable pad 128 may be a bladder-type pad that can accommodate and expel fluids or liquids to increase or decrease the size of the inflatable pad 128. In one embodiment, the inflatable pad 128 is filled with a heating gel to act as a heat source during blood collection, which promotes blood flow in the patient's finger. Referring to FIG. 11 , according to one non-limiting embodiment or aspect, the holder 12 may be designed as a two-part configuration, including a first part including the inflatable pad 128 and wings 38 and a second part including an adjustable band 130 for holding the finger cuff and the patient's finger to the holder 12.

[0065] 12 , according to one non-limiting embodiment or aspect of the present disclosure, holder 12 may include a foam port 132 configured to allow expanding foam 134 to be directed into holder 12 to surround patient's finger 19 and ensure the patient's finger is comfortably seated within holder 12. Based on the size of the patient's finger 19, expanding foam 134 may be used to allow smaller patient's fingers 19 to be received and held within holder 12 without moving within the excess space of holder 12. In one embodiment, expanding foam 134 may be filled with a heating gel to act as a heat source to promote blood flow in patient's finger 19.

[0066] 13 , according to one non-limiting embodiment or aspect of the present disclosure, holder 12 includes a hook-and-loop strap 136 to allow the size of holder 12 to be adjusted to accommodate various patient finger sizes. Hook-and-loop strap 136 may be integrated into holder 12 or may be a separate hook-and-loop strap band that fastens on the outer surface of holder 12 to secure holder 12 to the patient's finger.

[0067] 14 , according to one non-limiting embodiment or aspect of the present disclosure, the holder 12 may include a rigid shell 138 having an inflatable pad 140 disposed in an interior channel of the rigid shell 138. The inflatable pad 140 may be filled with any fluid or liquid, such as air, to increase or decrease the diameter of the channel defined by the rigid shell 138. The inflatable pad 140 may be inflated and deflated to accommodate a number of different sized patient fingers and may be controlled by a control unit 142. The liquid or fluid used in the inflatable pad 140 may be heated to act as a heat source to promote blood flow in the patient's finger.

[0068] While different embodiments of the blood collection device and method are shown in the accompanying drawings and described in detail herein, other embodiments will be apparent to and readily made by those skilled in the art without departing from the scope and spirit of the invention. Accordingly, the foregoing description is intended to be illustrative rather than limiting. The invention as described herein is defined by the appended claims, and all modifications of the invention that come within the meaning and range of equivalency of the claims are embraced within their scope.

Claims

1. 1. A device for obtaining a blood sample, said device comprising: a holder for receiving a sample source, said holder having an actuation portion and a port; a container engaging portion connected to the holder; and a pain relief member provided on the inner surface of the holder; An apparatus comprising:

2. The device of claim 1 , wherein the pain relief member comprises at least one elastomeric material positioned on the inner surface of the holder.

3. The device of claim 1 , wherein the pain relief member is positioned on an inner surface of the working portion of the holder.

4. The device of claim 2 , wherein the at least one elastomeric material is positioned to contact a rear portion of the sample source held in the holder.

5. The device of claim 1 , wherein the pain relief member comprises a ring configured to cover an outer periphery of the sample source.

6. The device of claim 5 , wherein the ring is made of an elastomeric material.

7. The device of claim 5 , wherein the ring includes a plurality of ribs or bumps on its outer surface for gripping the holder.

8. The device of claim 1 , wherein the sample source is a finger.

9. The device of claim 8 , wherein the port communicates with a portion of the finger when the finger is received in the holder.

10. The device of claim 1 , wherein the actuating portion comprises a pair of opposing wings configured to be pumped to aspirate the blood sample from the sample source.

11. 1. A device for collecting a blood sample, said device comprising: a holder for receiving a sample source, said holder having an actuation portion and a port; a container engaging portion connected to the holder; and a clamping device provided on the holder for adjusting the diameter of the holder that receives the sample source; An apparatus comprising:

12. The apparatus of claim 11 , wherein the clamping device comprises a zip tie for reducing the diameter of the holder to clamp the holder to the sample source.

13. 13. The device of claim 12, wherein the zip tie includes a zip tie strap on a first portion of the holder and a zip tie opening on a second portion of the holder.

14. The apparatus of claim 11 , wherein the clamping device is provided on a bottom surface of the holder.

15. The device of claim 11 , wherein the sample source is a finger.

16. 16. The device of claim 15, wherein the port communicates with a portion of the finger when the finger is received within the holder.

17. 12. The device of claim 11, wherein the actuating portion comprises a pair of opposing wings configured to be pumped to collect a blood sample from the sample source.

18. The apparatus of claim 11 , wherein the actuating portion includes a pump member for applying pressure to the sample source.

19. 1. A kit for use in obtaining a blood sample, said kit comprising:

1. A blood collection device comprising: a holder for receiving a sample source, said holder having an actuation portion and a port; and a container engaging portion connected to the holder; a blood collection device comprising: a pain relief member separate from the blood collection device, the pain relief member configured to minimize or eliminate pain experienced from the sample source held in the holder; A kit comprising:

20. 20. The kit of claim 19, wherein the pain relief member comprises an elastomeric ring configured to surround an outer periphery of the sample source.

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