Lancing finger sleeve

Abstract

A sleeve, including a first end, a second end, and a passage therethrough configured to at least partially receive a finger therein; a port adjacent the first end, the port being substantially transverse to a longitudinal axis of the passage; and a connector at least partially surrounding the port, the connector configured to releasably attach to a collection container. The sleeve may include an insert attached to the sleeve, the insert including a first section adjacent the first end of the sleeve and defining an aperture at least partially aligned with the port; and a second section adjacent the second end of the sleeve and connected to the first section, where the second section is configured to exert pressure on a midsection of a finger within the passage.

Description

LANCING FINGER SLEEVECROSS-REFERENCE TO RELATED APPLICATION

[0001] The present application claims priority to United States Provisional Patent Application No. 63 / 584,323 entitled “Lancing Finger Sleeve” filed September 21, 2023, the disclosure of which is hereby incorporated by reference in its entirety.FIELD OF THE INVENTION

[0002] The present disclosure relates generally to a device for obtaining a biological sample. More particularly, the present disclosure relates to a finger-based capillary blood collection device and methods of use thereof.BACKGROUND OF THE INVENTION

[0003] Devices for obtaining and collecting biological samples, such as blood samples, are commonly used in the medical industry. One type of blood collection that is commonly done in the medial field is capillary blood collection which is often done to collect blood samples for testing. Certain diseases, such as diabetes, require that the patient's blood be tested on a regular basis to monitor, for example, the patient's blood sugar levels. Additionally, test kits, such as cholesterol test kits, often require a blood sample for analysis. The blood collection procedure usually involves pricking a finger or other suitable body part in order to obtain the blood sample. Typically, the amount of blood needed for such tests is relatively small and a small puncture wound or incision normally provides a sufficient amount of blood for these tests. Various types of lancet devices have been developed which are used for puncturing the skin of a patient to obtain a capillary blood sample from the patient.

[0004] Currently, capillary blood collection workflow is a complex multi-step process requiring high skill level. The multi-step nature of this process introduces several variables that could cause sample quality issues. Some of the most common sources of process variability are: (1) inadequate lancing site cleaning and first drop removal which can potentially result in a contaminated sample; (2) inconsistent lancing location and depth which could potentially result in insufficient sample volume and a large fraction of interstitial fluid; (3) inconsistent squeezing technique and excessive pressure near the lancing site to promote blood extraction (e.g., blood milking) which could potentially result in a hemolyzed sample; and (4) variable transfer interfaces and collection technique which could potentially result in ahemolyzed or contaminated sample. It would be beneficial to provide devices and methods of use thereof for collecting such blood samples that address and overcome these shortcomings.SUMMARY OF THE INVENTION

[0005] The present disclosure provides a sleeve, including a first end, a second end, and a passage therethrough configured to at least partially receive a finger therein; a port adjacent the first end, the port being substantially transverse to a longitudinal axis of the passage; and a connector at least partially surrounding the port, the connector configured to releasably attach to a collection container. The sleeve may be constructed from at least one of rubber, silicone or isoprene. The connector may include first and second interlocking segments spaced from each other, wherein each interlocking segment defines a substantially semi-circular shape. The sleeve may include an insert attached to the sleeve, the insert having a first section adjacent the first end of the sleeve, and a second section adjacent the second end of the sleeve and connected to the first section. The insert may include at least one arm extending between and connecting the first and section sections. The first section of the insert may define an aperture at least partially aligned with the port. The second section of the insert may have a rounded shape configured to exert pressure on a midsection of a finger within the passage. The sleeve may include an orientation indicia on an exterior surface thereof. The orientation indicia may include an illustration of at least a portion of a finger.

[0006] A sleeve is disclosed, including a first end, a second end, and a passage therethrough configured to at least partially receive a finger therein; a port adjacent the first end, the port being substantially transverse to a longitudinal axis of the passage; and an insert attached to the sleeve, the insert having: a first section adjacent the first end of the sleeve, the first section defining an aperture at least partially aligned with the port; and a second section adjacent the second end of the sleeve and connected to the first section, wherein the second section is configured to exert pressure on a midsection of a finger within the passage. The sleeve may include a connector at least partially surrounding the port, the connector configured to releasably attach to a collection container. The sleeve may be constructed from at least one of rubber, silicone or isoprene. The second section of the insert may have a rounded shape. The sleeve may include an orientation indicia on the sleeve.

[0007] A method of collecting a fluid sample is disclosed, the method including positioning at least a portion of a finger in a longitudinal passage of a sleeve, wherein the sleeve defines a port substantially transverse to the longitudinal passage, and a connector substantially surrounding the port; lancing a portion of the finger through the port; attaching the connectorto a collection container; and collecting a fluid sample from the lanced portion of the finger with the collection container. The sleeve may include an insert attached thereto, the insert having: a first section defining an aperture at least partially aligned with the port; and a second section adjacent the second end of the sleeve and connected to the first section, wherein the method further includes exerting pressure on a midsection of the finger with the second section of the insert. Exerting pressure on a midsection of the finger with the second section of the insert may include at least partially bending the finger.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] A more complete understanding of the present disclosure, and the attendant advantages and features thereof, will be more readily understood by reference to the following detailed description when considered in conjunction with the accompanying drawings, wherein:

[0009] FIG. 1 illustrates an example of a finger sleeve constructed in accordance with the principles of the present disclosure;

[0010] FIG. 2 is a closer view of the finger sleeve of FIG. 1;

[0011] FIG. 3 is another view of the finger sleeve of FIG. 1; and

[0012] FIG. 4 is yet another view of the finger sleeve of FIG. 1.DETAILED DESCRIPTION OF THE INVENTION

[0013] The following description is provided to enable those skilled in the art to make and use the described aspects contemplated for carrying out the invention. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention.

[0014] As used herein, the singular form of “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise.

[0015] Spatial or directional terms, such as “left”, “right”, “inner”, “outer”, “above”, “below”, and the like, relate to the embodiments or aspects as shown in the drawing figures and are not to be considered as limiting as the embodiments or aspects can assume various alternative orientations.

[0016] All numbers used in the specification and claims are to be understood as being modified in all instances by the term “about”. By “about” is meant within plus or minus twenty-five percent of the stated value. However, this should not be considered as limiting to any analysis of the values under the doctrine of equivalents.

[0017] Unless otherwise indicated, all ranges or ratios disclosed herein are to be understood to encompass the beginning and ending values and any and all subranges or subratios subsumed therein. For example, a stated range or ratio of “1 to 10” should be considered to include any and all subranges or subratios between (and inclusive of) the minimum value of 1 and the maximum value of 10; that is, all subranges or subratios beginning with a minimum value of 1 or more and ending with a maximum value of 10 or less. The ranges and / or ratios disclosed herein represent the average values over the specified range and / or ratio.

[0018] The terms “first”, “second”, and the like are not intended to refer to any particular order or chronology, but refer to different conditions, properties, or elements.

[0019] All documents referred to herein are “incorporated by reference” in their entirety.

[0020] The term “at least” is synonymous with “greater than or equal to.”

[0021] 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.

[0022] The word “comprising” and “comprises”, and the like, does not exclude the presence of elements or steps other than those listed in any claim or the specification as a whole. In the present specification, “comprises” means “includes” and “comprising” means “including.”

[0023] As used herein, the terms “parallel” or “substantially parallel” mean a relative angle as between two objects (if extended to theoretical intersection), such as elongated objects and including reference lines, that is from 0° to 5°, or from 0° to 3°, or from 0° to 2°, or from 0° to 1°, or from 0° to 0.5°, or from 0° to 0.25°, or from 0° to 0.1°, inclusive of the recited values.

[0024] As used herein, the terms “perpendicular”, “transverse”, “substantially perpendicular,” or “substantially transverse” mean a relative angle as between two objects at their real or theoretical intersection is from 85° to 90°, or from 87° to 90°, or from 88° to 90°, or from 89° to 90°, or from 89.5° to 90°, or from 89.75° to 90°, or from 89.9° to 90°, inclusive of the recited values.

[0025] Now referring to the attached figures, an example of a sleeve 10 constructed in accordance with the principles of the present invention is shown. For example, as shown in FIGS. 1-4, the sleeve 10 generally defines or includes a substantiality tubular or cylindrical body. The sleeve 10 generally defines or includes a first end 12, a second end 14, and a passage 16 therein sized and configured to receive at least a portion of a finger or other appendagetherein. A longitudinal axis Al extends along the length of the passage 16 and the body of the sleeve 10 from the first end 12 to the second end 14. In one example, the sleeve 10 has sufficient length such that the first end 12 is positionable adjacent to or in proximity to a fingertip (e.g., distal portion) of a finger within the passage 16, and the second end 14 is positionable adjacent or in proximity to a knuckle or midsection of the finger.

[0026] The sleeve 10 may be constructed from one or more materials providing sufficient elasticity to accommodate a range of finger sizes, and sufficient compression to aid or improve blood flow for collection. For example, the sleeve 10 may be constructed from rubber, silicone or isoprene. The sleeve 10 may further define a wall thickness to provide the desired elasticity and compression. The sleeve 10 may generally have an elastic expansion characteristic sufficient to expand a diameter of the passage 16 from the original, unexpanded size.

[0027] The sleeve 10 defines or includes a port 18 adjacent to or in proximity to the first end 12 of the sleeve 10. The port 18 is configured to facilitate accurate targeting and puncture of the finger within the sleeve 10, as described herein. The port 18 may include or define an opening or aperture in a sidewall of the sleeve 10 to access or expose a portion of the finger or appendage disposed within the passage 16. The port 18 may generally be substantially transverse or perpendicular to the passage 16 and / or the longitudinal axis Al. The port 18 may be sized and shaped to circumscribe or surround a portion of the finger to be lanced for subsequent blood collection. Although the port is illustrated as a rounded or circular opening, other geometries may be implemented to accommodate variations in targeted anatomy or lancet configuration.

[0028] The sleeve 10 may include a connector 20 configured to matably engage or releasably attach to a complimentary structure or portion of a collection container 22. For example, the connector 20 may include or define a first interlocking segment 20a and a second interlocking segment 20b that substantially surround or circumscribe the port 18. In the illustrated example, the first and second interlocking segments 20a, 20b are separate substantially semi-circular components spaced apart from each other. The interlocking segments 20a, 20b are sized and shaped to engage an interior or exterior diameter of an opening in the collection container 22 to form a compression fit or snap fit between the connector 20 and the collection container 22. The connector 20 may include additional or alternative geometric and mechanical features to provide a secure coupling to the collection container 22.

[0029] The connector 20 may be constructed from one or more materials providing sufficient strength to withstand the forces exerted during coupling and de-coupling from the collection container 22.

[0030] Now referring to FIG. 3, the sleeve 10 may include an insert 24 attached to or embedded therein configured to apply pressure to one or more pressure points on or adjacent to the mid- and distal portions of the finger within the sleeve 10, and thereby improve blood flow for collection. The insert 24 may generally define a first section 26 adjacent or in proximity to the first end 12 of the sleeve 10, and a second section 28 adjacent or in proximity to the second end 14 of the sleeve 10. The first section 26 may include a rounded profile with an aperture 30 therein that aligns with or at least partially surrounds a portion of the port 18 and / or the connector 20. The aperture 30 may be sized and shaped similarly to the port 18 and / or connector 20 to present a coaxial, aligned access opening that exposes a surface of the finger positioned within the sleeve 10 for lancing and blood collection. The second section 28 may define or include a generally rounded or button-shaped profile positionable to abut a proximal or midsection of the finger in the sleeve 10. The insert 24 may include one or more arms 32 that extend between and connect the first and second sections of the insert 24.

[0031] The insert 24 may be sufficiently flexible as to allow a finger or appendage within the sleeve 10 to bend, while providing sufficient resistance or rigidity to exert pressure on the finger through the first and second sections when the insert 24 is at least partially bent or an external pressure is exerted thereon. The insert may have a generally slim or low 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 be adhered to an inner surface of the passage 16 to directly abut or contact a finger or appendage therein, or may alternatively be embedded within one or more layers of material constituting the sleeve 10.

[0032] The insert 24 may have a unitary, single-piece construction including the first and second sections 26, 28 and the arms 32. In one example, the connector 20 may also be formed integral with or otherwise attached to the insert 24 (the connector 20 is not shown in FIG. 3 for ease of illustrating the features of the insert 24).

[0033] The sleeve 10 may include one or more orientation indicia 34 located on one or more portions of the sleeve 10 to aid a clinician or user in positioning the sleeve 10 about a finger or appendage to collect a fluid sample. For example, the one or more orientation indicia 34 may include an arrow or other directional signal, signage, or visual marker to aid in positioning the first end 12 of the sleeve 10 adjacent or in proximity to a distal end or tip of the finger. The orientation indicia 34 may additionally or alternatively provide visual aids or markers to locate and properly position the second end 14 and / or port 18 in the desired position for effective blood sampling. In the example illustrated in FIG. 4, the orientation indicia 34 includes a graphical or illustrative representation of at least portion of a finger (such as a fingernail,knuckle, or other anatomical feature) to aid in properly positioning the sleeve 10. The orientation indicia 34 may be printed on or otherwise attached to an exterior surface of the sleeve 10.

[0034] The sleeve 10 may include or otherwise be used with additional mechanical, biological, and / or pharmaceutical components to aid in obtaining a sample from a finger within the sleeve 10. For example, one or more vasodilating agents or thermal agents may be applied, coated, and / or embedded into one or more surfaces or components of the sleeve 10. One or more heating elements, vibration mechanisms, and / or compression mechanisms (for example, a belt, tie, lace, or other diameter restricting means) may be implemented into, on, or otherwise in conjunction with the sleeve 10.

[0035] In an exemplary method of use, the sleeve 10 may be positioned over at least a portion of a finger or appendage such that the first end 12 is adjacent or in proximity to a distal portion or tip of a finger, the port 18 is adjacent or in proximity to an underside of a fingertip where a sample is to be drawn, and the second end 14 and / or the second section 28 of the insert 24 are adjacent or in proximity to a midsection of the finger. The orientation indicia 34 may guide the positioning of the sleeve 10 about the finger or appendage as it is received within the passage 16 and adjusted accordingly to achieve the desired position and orientation between the sleeve 10 and finger.

[0036] Once in the sleeve 10 is in the desired position, a lance or other puncturing device may be used to break or pierce the skin of the finger or appendage exposed through the port 18. The connector 20 of the sleeve 10 may then be attached, engaged, or otherwise coupled to the collection container 22 such that a fluid sample from the finger or appendage flows into the container. The fluid flow from the finger is improved or aided by the pressure exerted on the finger by the sleeve, and may also be enhanced by the insert 24. For example, the finger may be at least partially bent such that the second section 28 of the insert 24 applies pressure to the midsection of the finger, thereby promoting fluid flow from proximal portions of the finger to the distal portion of the finger exposed by the port 18 and / or at least partially surrounded by the first section 26 of the insert 24. Additionally and / or alternatively, external pressure may be applied to the second section 28 of the insert 24 by directly pressing down on the second section 28 to apply pressure to the midsection of the finger.

[0037] The devices and methods disclosed herein consistently yield high volumes of fluid sampling through the distinctly identified puncture site of the lancing port, and providing optimum amounts of passive pressure and active pressure on the surrounding tissue of the distal and intermediate sections of the finger to encourage blood flood into the target capillaries, andinto the collection container. The connection between the sleeve and the collection container further facilitates efficient sample collection and avoids spillage while reducing the likelihood of contaminating the sample.

[0038] It will be appreciated by persons skilled in the art that the present disclosure is not limited to what has been particularly shown and described herein above. In addition, unless mention was made above to the contrary, it should be noted that all of the accompanying drawings are not to scale. Of note, the system components have been represented where appropriate by conventional symbols in the drawings, showing only those specific details that are pertinent to understanding the embodiments of the present disclosure so as not to obscure the disclosure with details that will be readily apparent to those of ordinary skill in the art having the benefit of the description herein. Moreover, while certain embodiments or figures described herein may illustrate features not expressly indicated on other figures or embodiments, it is understood that the features and components of the examples disclosed herein are not necessarily exclusive of each other and may be included in a variety of different combinations or configurations without departing from the scope and spirit of the disclosure. A variety of modifications and variations are possible in light of the above teachings without departing from the scope and spirit of the disclosure, which is limited only by the following claims.

Claims

WHAT IS CLAIMED IS:

1. A sleeve, adapted to receive a portion of a patient therein, comprising: a first end, a second end, and a passage therethrough configured to at least partially receive a finger therein; a port adjacent the first end, the port being substantially transverse to a longitudinal axis of the passage; and a connector at least partially surrounding the port, the connector configured to releasably attach to a collection container.

2. The sleeve of claim 1, wherein the sleeve is constructed from at least one of rubber, silicone or isoprene.

3. The sleeve of claim 1, wherein the connector includes first and second interlocking segments spaced 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: a first section adjacent the first end of the sleeve, and a second section adjacent the second end of the sleeve and connected to the first section.

5. The sleeve of claim 4, wherein the insert further comprises at least one arm extending between and connecting the first and section sections.

6. The sleeve of claim 4, wherein the first section of the insert defines an aperture at least partially aligned with the port.

7. The sleeve of claim 4, wherein the second section of the insert has a rounded shape configured to exert pressure on a midsection of a finger within the passage.

8. The sleeve of claim 1, further comprising an orientation indicia on the sleeve.

9. The sleeve of claim 8, wherein the orientation indicia includes an illustration of at least a portion of a finger.

10. A sleeve, comprising: a first end, a second end, and a passage therethrough configured to at least partially receive a finger therein; a port adjacent the first end, the port being substantially transverse to a longitudinal axis of the passage; and an insert attached to the sleeve, the insert comprising: a first section adjacent the first end of the sleeve, the first section defining an aperture at least partially aligned with the port; and a second section adjacent the second end of the sleeve and connected to the first section, wherein the second section is configured to exert pressure on a midsection of a finger within the passage.

11. The sleeve of claim 10, further comprising a connector at least partially surrounding the port, the connector configured to releasably attach to a collection container.

12. The sleeve of claim 10, wherein the sleeve is constructed from at least one of rubber, silicone or isoprene.

13. The sleeve of claim 10, wherein the second section of the insert has a rounded shape.

14. The sleeve of claim 10, further comprising an orientation indicia on the sleeve.

15. A method of collecting a fluid sample, comprising: positioning at least a portion of a finger in a longitudinal passage of a sleeve, wherein the sleeve defines a port substantially transverse to the longitudinal passage, and a connector substantially surrounding the port; lancing a portion of the finger through the port; attaching the connector to a collection container; andcollecting a fluid sample from the lanced portion of the finger with the collection container.

16. The method of claim 15, wherein the sleeve includes an insert attached thereto, the insert comprising: a first section defining an aperture at least partially aligned with the port; and a second section adjacent the second end of the sleeve and connected to the first section, wherein the method further comprises exerting pressure on a midsection of the finger with the second section of the insert.

17. The method of claim 16, wherein exerting pressure on a midsection of the finger with the second section of the insert includes at least partially bending the finger.

Images