Piercing finger sleeve
By designing a sleeve device, including a sleeve, connector, and insert, the sample quality problem in the capillary blood collection process was solved, the blood collection steps were simplified, and the sample collection efficiency and quality were improved.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- BECTON DICKINSON & CO
- Filing Date
- 2024-09-23
- Publication Date
- 2026-06-16
Smart Images
Figure CN122228058A_ABST
Abstract
Description
Cross-references to related applications
[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 584,323, filed on September 21, 2023, entitled “Lancing Finger Sleeve,” the disclosure of which is incorporated herein by reference in its entirety. Technical Field
[0002] This disclosure generally relates to an apparatus for obtaining biological samples. More particularly, this disclosure relates to a finger-based capillary blood collection device and its method of use. Background Technology
[0003] Devices used to obtain and collect biological samples (e.g., blood samples) are commonly used in the medical field. One common blood collection method in medicine is capillary aspiration, which is typically used to collect blood samples for testing. Certain diseases (e.g., diabetes) require regular blood tests to monitor, for example, blood sugar levels. Furthermore, diagnostic kits (e.g., cholesterol test kits) often require blood samples for analysis. Blood collection procedures typically involve pricking a finger or other suitable body part to obtain a blood sample. Generally, this type of testing requires a relatively small amount of blood; a small puncture wound or incision usually provides sufficient blood for these tests. Various types of lancet devices have been developed for puncturing a patient's skin to obtain capillary blood samples.
[0004] Currently, capillary blood collection is a complex, multi-step process requiring a high level of skill. This multi-step nature introduces several variables that can lead to sample quality issues. Some of the most common sources of process variability are: (1) inadequate cleaning of the puncture site and removal of the first drop, which can potentially lead to sample contamination; (2) inconsistent puncture location and depth, which can potentially lead to insufficient sample volume and excessive interstitial fluid; (3) inconsistent squeezing techniques and excessive pressure near the puncture site that promotes blood extraction (e.g., blood squeezing), which can potentially lead to hemolysis; and (4) variable transfer interfaces and collection techniques, which can potentially lead to hemolysis or contamination. Providing devices and methods of use for collecting such blood samples that address and overcome these drawbacks would be beneficial. Summary of the Invention
[0005] This disclosure provides a sleeve comprising: a first end, a second end, and a channel through the sleeve configured to at least partially receive a finger therein; a port adjacent to the first end, the port being substantially transverse to the longitudinal axis of the channel; and a connector at least partially surrounding the port, the connector being configured to releasably attach to a collection container. The sleeve may be made of at least one of rubber, silicone, or isoprene. The connector may include a first interlocking segment and a second interlocking segment spaced apart from each other, wherein each interlocking segment defines a substantially semi-circular shape. The sleeve may include an insert attached to the sleeve having: a first segment adjacent to the first end of the sleeve, and a second segment adjacent to the second end of the sleeve and connected to the first segment. The insert may include at least one arm extending between and connecting the first and second segments. The first segment of the insert may define an orifice at least partially aligned with the port. The second segment of the insert may have a rounded shape configured to apply pressure to the middle segment of the finger within the channel. The sleeve may include orientation marks on its outer surface. The orientation marks may include an illustration of at least a portion of the finger.
[0006] A sleeve is disclosed, comprising: a first end, a second end, and a channel through the sleeve configured to at least partially receive a finger therein; a port adjacent to the first end, the port being substantially transverse to the longitudinal axis of the channel; and an insert attached to the sleeve, the insert having: a first segment adjacent to the first end of the sleeve defining an orifice at least partially aligned with the port; and a second segment adjacent to the second end of the sleeve and connected to the first segment, wherein the second segment is configured to apply pressure to the middle portion of the finger within the channel. The sleeve may include a connector at least partially surrounding the port, the connector being configured to releasably attach to a collection container. The sleeve may be made of at least one of rubber, silicone, or isoprene. The second segment of the insert may have a rounded shape. The sleeve may include orientation marks located on the sleeve.
[0007] A method for collecting a fluid sample is disclosed, the method comprising: positioning at least a portion of a finger in a longitudinal channel of a sleeve, wherein the sleeve defines a port substantially transverse to the longitudinal channel and a connector substantially surrounding the port; piercing a portion of the finger through the port; attaching the connector to a collection container; and collecting a fluid sample from the pierced portion of the finger using the collection container. The sleeve may include an insert attached to the sleeve, the insert having: a first section defining an orifice at least partially aligned with the port; and a second section adjacent to a second end of the sleeve and connected to the first section, wherein the method further comprises applying pressure to the middle portion of the finger using the second section of the insert. Applying pressure to the middle portion of the finger using the second section of the insert may include at least partially bending the finger. Attached Figure Description
[0008] A more complete understanding of this disclosure and its accompanying advantages and features will be more readily obtained by referring to the following detailed description in conjunction with the accompanying drawings: Figure 1 An example of a finger sleeve constructed according to the principles of this disclosure is shown; Figure 2 for Figure 1 A close-up view of the finger sleeve; Figure 3 for Figure 1 Another view of the finger sleeve; and Figure 4 for Figure 1 Another view of the finger sleeve. Detailed Implementation
[0009] The following description is provided to enable those skilled in the art to make and use the described aspects intended for carrying out the invention. However, various modifications, equivalents, variations, and substitutions will be apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and substitutions are intended to fall within the spirit and scope of the invention.
[0010] Unless the context clearly indicates otherwise, as used herein, the singular forms “a,” “one,” and “the” include plural referents.
[0011] Spatial or directional terms such as “left,” “right,” “inner,” “outer,” “above,” and “below” relate to the embodiments or aspects shown in the accompanying drawings and should not be considered limiting, as various alternative orientations may be adopted for the embodiments or aspects.
[0012] All figures used in the specification and claims should be understood to be modified in all cases by the term "about". "About" refers to a range of plus or minus twenty-five percent of the stated value. However, this should not be regarded as a limitation on any value analysis under the doctrine of equivalence.
[0013] Unless otherwise stated, all ranges or ratios disclosed herein should be understood to encompass both the starting and ending values, and any and all subranges or subratios contained therein. For example, the stated range or ratio “1 to 10” should be considered to include any and all subranges or subratios between the minimum value of 1 and the maximum value of 10 (inclusive); that is, all subranges or subratios begin with a minimum value of 1 or greater and end with a maximum value of 10 or less. The ranges and / or ratios disclosed herein represent the average of a particular range and / or ratio.
[0014] The terms “first”, “second”, etc., do not refer to any specific order or sequence, but rather to different conditions, characteristics, or elements.
[0015] All documents mentioned in this article are incorporated in their entirety by reference.
[0016] The term "at least" is synonymous with "greater than or equal to".
[0017] As used herein, “at least one of…” is synonymous with “one or more of…”. For example, the phrase “at least one of A, B, or C” means any one of A, B, or C, or any combination of any two or more of A, B, or C. For example, “at least one of A, B, and C” includes A alone; or B alone; or C alone; or A and B; or A and C; or B and C; or all of A, B, and C.
[0018] The terms "comprising" and "including" do not exclude the presence of any elements or steps other than those listed in any claim or the entire specification. In this specification, "comprising" means "including," and "including" means "comprising."
[0019] As used herein, the term “parallel” or “substantially parallel” means a relative angle between two objects (if extended to a theoretical point of intersection) (e.g., an elongated object and including a reference line) of 0° to 5°, or 0° to 3°, or 0° to 2°, or 0° to 1°, or 0° to 0.5°, or 0° to 0.25°, or 0° to 0.1°, including the stated values.
[0020] As used herein, the terms “vertical,” “lateral,” “substantially vertical,” or “substantially lateral” mean that the relative angle between two objects at their actual or theoretical point of intersection is 85° to 90°, or 87° to 90°, or 88° to 90°, or 89° to 90°, or 89.5° to 90°, or 89.75° to 90°, or 89.9° to 90°, including the stated values.
[0021] Referring now to the accompanying drawings, an example of a sleeve 10 constructed according to the principles of the present invention is shown. For example, as... Figures 1 to 4 As shown, the sleeve 10 typically defines or includes a substantially tubular or cylindrical body. The sleeve 10 typically defines or includes a first end 12, a second end 14, and a channel 16 within the sleeve, the channel 16 being sized and configured to receive at least a portion therein of a finger or other appendage. A longitudinal axis A1 extends from the first end 12 to the second end 14 along the length of the channel 16 and the body of the sleeve 10. In one example, the sleeve 10 has sufficient length such that the first end 12 can be positioned adjacent to or near the fingertip (e.g., the distal portion) of a finger within the channel 16, and the second end 14 can be positioned adjacent to or near the knuckle or middle segment of a finger.
[0022] The sleeve 10 can be made of one or more materials that provide sufficient elasticity to accommodate various finger sizes and sufficient compressibility to aid or improve blood flow for collection. For example, the sleeve 10 can be made of rubber, silicone, or isoprene. The sleeve 10 can be further defined in wall thickness to provide the desired elasticity and compressibility. The sleeve 10 can typically have elastic expansion properties sufficient to expand the diameter of the channel 16 from its original unexpanded size.
[0023] The sleeve 10 defines or includes a port 18 adjacent to or near a first end 12 of the sleeve 10. As described herein, the port 18 is configured to facilitate accurate aiming and puncture of a finger within the sleeve 10. The port 18 may include or define an opening or orifice in the sidewall of the sleeve 10 to access or expose a portion of a finger or appendage disposed within the channel 16. The port 18 may generally be substantially transverse to or perpendicular to the channel 16 and / or longitudinal axis A1. The port 18 may be sized and shaped to surround or enclose a portion of the finger to be punctured for subsequent blood collection. Although the port is shown as a rounded opening or a circular opening, other geometries may be implemented to accommodate variations in target anatomy or lancet construction.
[0024] Sleeve 10 may include connector 20, configured to mate with or releasably attach to a complementary structure or portion of collection container 22. For example, connector 20 may include or define a first interlocking segment 20a and a second interlocking segment 20b that substantially surrounds or encloses port 18. In the example shown, the first interlocking segment 20a and the second interlocking segment 20b are separate, substantially semi-circular components spaced apart from each other. Interlocking segments 20a, 20b are sized and shaped to engage the inner or outer diameter of an opening in collection container 22 to form a press-fit or snap-fit between connector 20 and collection container 22. Connector 20 may include additional or alternative geometric and mechanical features to provide a secure connection with collection container 22.
[0025] The connector 20 may be made of one or more materials that provide sufficient strength to withstand the forces applied when connecting to and disconnecting from the collection container 22.
[0026] Now for reference Figure 3 The sleeve 10 may include an insert 24 attached thereto or embedded therein, the insert 24 being configured to apply pressure to one or more pressure points on or near the middle and distal portions of the finger within the sleeve 10, thereby improving blood flow for collection. The insert 24 may generally define a first segment 26 adjacent to or near a first end 12 of the sleeve 10, and a second segment 28 adjacent to or near a second end 14 of the sleeve 10. The first segment 26 may include a rounded profile having an aperture 30 that aligns with or at least partially surrounds a portion of the port 18 and / or connector 20. The aperture 30 may be sized and shaped similarly to the port 18 and / or connector 20 to provide a coaxial, aligned access opening that exposes the surface of the finger located within the sleeve 10 for puncture and blood collection. The second segment 28 may define or include a substantially rounded or button-shaped profile, positioned adjacent to the proximal or middle portion of the finger within the sleeve 10. The insert 24 may include one or more arms 32 that extend between and connect the first and second segments of the insert 24.
[0027] The insert 24 may have sufficient flexibility to allow a finger or appendage within the sleeve 10 to bend, while providing sufficient resistance or stiffness to apply pressure to the finger via the first and second sections when the insert 24 is at least partially bent or subjected to external pressure. The insert may have a generally slender or low-profile side profile. The insert 24 may be attached to or otherwise coupled to the sleeve 10 in various ways. For example, the insert 24 may adhere to the inner surface of the channel 16 to directly abut or contact a finger or appendage therein, or alternatively may be embedded within one or more layers of material constituting the sleeve 10.
[0028] Insert 24 may have an integral, single-piece structure, including a first segment 26, a second segment 28, and an arm 32. In one example, connector 20 may also be integrally formed with insert 24 or otherwise attached to insert 24 (for ease of illustrating the features of insert 24, in...). Figure 3 Connector 20 is not shown in the image.
[0029] The sleeve 10 may include one or more orientation marks 34 located on one or more portions of the sleeve 10 to assist clinicians or users in positioning the sleeve 10 relative to a finger or appendage for fluid sample collection. For example, one or more orientation marks 34 may include arrows or other directional signals, signs, or visual identifiers to help position the first end 12 of the sleeve 10 adjacent to or near the distal end or fingertip of the finger. The orientation marks 34 may additionally or alternatively provide visual aids or identifiers to place and correctly position the second end 14 and / or port 18 at the desired location for effective blood collection. Figure 4 In the example shown, orientation mark 34 includes a graphic or illustrative representation of at least a portion of a finger (e.g., fingernail, knuckle, or other anatomical feature) to aid in the correct positioning of sleeve 10. Orientation mark 34 may be printed on or otherwise attached to the outer surface of sleeve 10.
[0030] The sleeve 10 may include, or be used in conjunction with, additional mechanical, biological, and / or pharmaceutical components to aid in obtaining samples from a finger within the sleeve 10. For example, one or more vasodilators or thermosensitive agents may be applied, coated, and / or embedded in one or more surfaces or components of the sleeve 10. One or more heating elements, vibration mechanisms, and / or compression mechanisms (e.g., belts, ties, laces, or other diameter limiting devices) may be implemented in, on, or otherwise combined with the sleeve 10.
[0031] In an exemplary method of use, the sleeve 10 may be positioned on at least a portion of a finger or appendage such that the first end 12 is adjacent to or near the distal portion of the finger or fingertip, the port 18 is adjacent to or near the underside of the fingertip from which the sample is to be extracted, and the second end 14 and / or the second segment 28 of the insert 24 is adjacent to or near the middle portion of the finger. Orientation markings 34 may guide the positioning of the sleeve 10 with respect to the finger or appendage when the finger or appendage is received within the channel 16, and may be adjusted accordingly to achieve the desired position and orientation between the sleeve 10 and the finger.
[0032] Once the sleeve 10 is in the desired position, the skin of the finger or appendage exposed through port 18 can be punctured or broken using a lancet or other puncture device. The connector 20 of the sleeve 10 can then be attached, engaged, or otherwise coupled to the collection container 22, allowing a fluid sample from the finger or appendage to flow into the container. Fluid flow from the finger is improved or aided by the pressure applied to the finger by the sleeve, and can also be enhanced by the insert 24. For example, the finger can be at least partially bent, causing the second segment 28 of the insert 24 to apply pressure to the middle of the finger, thereby promoting fluid flow from the proximal portion of the finger to the distal portion of the finger exposed by port 18 and / or at least partially surrounded by the first segment 26 of the insert 24. Additionally and / or alternatively, external pressure can be applied to the second segment 28 of the insert 24 by directly pressing down on the second segment 28 to apply pressure to the middle of the finger.
[0033] The apparatus and method disclosed herein continuously generate a large volume of fluid sample through a clearly identified puncture site, and provide optimal amounts of passive and active pressure to the surrounding tissue of the distal and intermediate segments of the finger to induce blood flow into the target capillaries and collection container. The connection between the sleeve and the collection container further facilitates efficient sample collection and prevents spillage, while reducing the possibility of sample contamination.
[0034] Those skilled in the art will understand that this disclosure is not limited to what has been specifically shown and described above. Furthermore, unless otherwise stated above, it should be noted that all the drawings are not drawn to scale. It is worth noting that in the drawings, system components have been indicated by conventional symbols where appropriate, and only those specific details relevant to understanding embodiments of this disclosure are shown to avoid obscuring this disclosure with details readily apparent to those skilled in the art as described herein. Moreover, while some embodiments or drawings described herein may show features not explicitly indicated in other drawings or embodiments, it should be understood that the features and components of the examples disclosed herein are not necessarily mutually exclusive and may be included in various different combinations or configurations without departing from the scope and spirit of this disclosure. Based on the foregoing teachings, various modifications and variations are possible without departing from the scope and spirit of this disclosure, which is defined only by the appended claims.
Claims
1. A sleeve adapted to receive a portion of a patient therein, the sleeve comprising: A first end, a second end, and a channel penetrating the sleeve, the channel being configured to at least partially receive a finger therein; The port adjacent to the first end is substantially transverse to the longitudinal axis of the channel; as well as A connector that at least partially surrounds the port, the connector being configured to be releasably attached to the collection container.
2. The sleeve according to claim 1, wherein, The sleeve is made of at least one of rubber, silicone or isoprene.
3. The sleeve according to claim 1, wherein, The connector includes a first interlocking segment and a second interlocking segment spaced apart from each other, wherein each interlocking segment defines a substantially semi-circular shape.
4. The sleeve of claim 1, further comprising an insert attached to the sleeve, the insert comprising: The first section adjacent to the first end of the sleeve, and The second section is adjacent to the second end of the sleeve and connected to the second section of the first section.
5. The sleeve according to claim 4, wherein, The insert further includes at least one arm that extends between the first segment and the second segment and connects the first segment and the second segment.
6. The sleeve according to claim 4, wherein, The first section of the insert defines an opening that is at least partially aligned with the port.
7. The sleeve according to claim 4, wherein, The second section of the insert has a rounded shape, which is configured to apply pressure to the middle section of the finger within the channel.
8. The sleeve according to claim 1, wherein the sleeve further comprises an orientation mark located on the sleeve.
9. The sleeve according to claim 8, wherein, The orientation markings include an illustration of at least a portion of a finger.
10. A sleeve, the sleeve comprising: A first end, a second end, and a channel penetrating the sleeve, the channel being configured to at least partially receive a finger therein; The port adjacent to the first end is substantially transverse to the longitudinal axis of the channel; as well as An insert attached to the sleeve, the insert comprising: A first section adjacent to a first end of the sleeve, the first section defining an orifice at least partially aligned with the port; and A second section adjacent to the second end of the sleeve and connected to the second section of the first section, wherein the second section is configured to apply pressure to the middle section of the finger within the channel.
11. The sleeve of claim 10, further comprising a connector at least partially surrounding the port, the connector being configured to be releasably attached to the collection container.
12. The sleeve according to claim 10, wherein, The sleeve is made of at least one of rubber, silicone or isoprene.
13. The sleeve according to claim 10, wherein, The second section of the insert has a rounded shape.
14. The sleeve of claim 10, further comprising an orientation mark located on the sleeve.
15. A method for collecting fluid samples, the method comprising: Position at least a portion of a finger in a longitudinal channel of a sleeve, wherein the sleeve defines a port substantially transverse to the longitudinal channel and a connector substantially surrounding the port; Pierce a portion of the finger through the port; Attach the connector to the collection container; and A fluid sample is collected from the punctured portion of the finger using the collection container.
16. The method of claim 15, wherein, The sleeve includes an insert attached to the sleeve, the insert comprising: A first section, the first section defining an opening at least partially aligned with the port; and The second segment, adjacent to the second end of the sleeve and connected to the first segment, further includes applying pressure to the middle section of the finger using the second segment of the insert.
17. The method according to claim 16, wherein, Applying pressure to the middle section of the finger using the second section of the insert includes at least partially bending the finger.