Device and system for blood sampling

• US 9,566,027 B2
• Filed: 06/23/2011
• Issued: 02/14/2017
• Est. Priority Date: 12/25/2007
• Status: Active Grant

• Current Assignee: Rapidx, Ltd.
• Original Assignee: Rapidx, Ltd.
• Inventors: Tamir, Nili
• Primary Examiner(s): Warden, Jill
• Assistant Examiner(s): FISHER, BRITTANY I
• Application Number:
  US13/806,512
• Publication Number:
  US 20130172711A1
• Time in Patent Office: 2,063 Days
• Field of Search: 422/410
• US Class Current: 1/1
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150114 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/150343 Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes sampling from within body cavities A61B5/150015, A61B5/150045
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150748 Having means for aiding positioning of the piercing device at a location where the body is to be pierced means for aiding positioning of devices for bringing media into the body A61M5/427, locating blood vessels A61B5/489
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/6826 Finger
• CPC Class Codes: A61B 5/6838 Clamps or clips

Abstract

A medical device is presented for reduced-pain blood sampling and testing. The device comprises a housing defining a finger site for supporting a user'"'"'s finger or a portion thereof within said finger site during the device operation; piercing, sampling and testing assemblies sequentially actuatable to successively initiate piercing, sampling and testing operational modes of the device; a carriage at least partially accommodated within said housing and being adapted for movement with respect to said finger site between its first position corresponding to the piercing mode of the device and a second position corresponding to the sampling and testing modes of the device, the device being thereby capable of operating in the piercing, sampling and testing modes while at a static position of the user'"'"'s finger.

Claims

1. A medical device for a blood test, the device comprising:

(i) a housing defining a finger site for supporting a user'"'"'s finger or a portion thereof within said finger site during the device operation;

(ii) piercing, sampling and testing assemblies sequentially actuatable to successively initiate piercing, sampling and testing operational modes of the device, the sampling assembly comprises a blood holding element configured as a two part element and comprising a first part being a hollow liquid reservoir for collecting and holding a predetermined volume of a liquid-phase blood sample freely flowing from the finger as a result of piercing, and a second part being selectively movable to be brought into an assembled position with said liquid reservoir thereabove, thereby forming a top portion of said blood holding element having a projecting sloped member and displaced into a dissembled position, thereby removing excess blood from said liquid reservoir,

said hollow liquid reservoir comprises a bottom plate movable between a first position, in which it is aligned with side walls of said liquid reservoir, corresponding to a closed state of the reservoir keeping collected blood in said liquid reservoir, and a second position, in which it is misaligned with the side walls corresponding to an open state of said liquid reservoir allowing blood flow from said liquid reservoir for immediate testing procedure within the device;

(iii) a carriage at least partially accommodated within said housing and being adapted for movement with respect to said finger site between its first position corresponding to the piercing mode of the device and a second position corresponding to the sampling and testing modes of the device, the device being thereby capable of operating in the piercing, sampling and testing modes while at a static position of the user'"'"'s finger.

2. A device according to claim 1, wherein the piercing assembly is accommodated inside said housing with respect to the finger site such that an operation of the piercing assembly in the piercing mode of the device is hidden from the user.

3. A device according to claim 1, comprising a finger holder element configured to be fit on the finger such as to apply pressure to the finger in a manner assisting in withdrawal of blood during the piercing and sampling modes and reducing pain associated with the blood test.

4. A device according to claim 3, wherein said finger holder comprises a band operable to be shifted from its open inoperative position to a closed-loop operative position in which it fits the finger, said band when in the operative position thereof applies the pressure to the finger while preventing over-pressing of the finger, thereby reducing pain involved in the blood test procedures.

5. A device according to claim 1, comprising a finger holder element configured to be fit on the finger such as to apply pressure to a certain location on the finger, said certain location being selected to be spaced a predetermined distance from at least one of the finger tip and a piercing orifice provided in said finger site.

6. A device according to claim 5, wherein said housing comprises a groove located within said finger site and being configured for immobilizingly receiving a portion of the finger holder element therein, thereby fixing a position of the finger with respect to said finger site, during the device operation, said groove being located at a predetermined distance from the piercing orifice, thereby ensuring the application of pressure to the finger by said finger holder element a certain predetermined distance from a location on the finger being pierced.

7. A device according to claim 1, wherein said housing comprises a protrusion defining a distal end of the finger site to be abutted by a finger tip during the device operation.

8. A device according to claim 1, wherein the piercing assembly comprises a piercing element movable along a first axis towards and away from the finger site and accessing the finger via an orifice in said finger site to perform piercing.

9. A device according to claim 8, wherein said piercing assembly is movable by said carriage along a second, intersecting axis, with respect to the finger site, between its first inoperative position in which the piercing element is not aligned with the orifice along the first axis and a second operative position in which the piercing elements is aligned with said orifice along the first axis.

10. A device according to claim 1, wherein the blood holding element is configured such that, when in the sampling mode of the device, the blood holding element has a top portion formed with a projecting sloped member for flowing a portion of collected blood volume above said predetermined volume out of a liquid reservoir towards an indication window, appearance of blood in the indication window being indicative of the blood holding element contains the predetermined volume of blood.

11. A device according to claim 1, wherein the testing assembly comprises a slot made in said housing for a test strip to be at least partially inserted therein in a manner enabling sliding movement of a test strip towards and away from a location of alignment with the piercing orifice.

12. A device according to claim 1, wherein the testing assembly comprises a test strip insertable into a position in which a portion thereof is aligned with a piercing orifice to receive a blood sample from the finger after piercing.

13. A device according to claim 1, wherein said carriage incorporates or is connected to elements of the piercing, sampling and testing assemblies such that the movement of the carriage with respect to the finger site successively brings said elements into an operative position in which the element of the respective assembly is aligned with the finger site corresponding to said first and second positions of the carriage.

14. A device according to claim 1, comprising a reagent holding unit mounted to be selectively brought into alignment position with respect to an element of the testing assembly, when in the testing mode of the device.

15. A system comprising:

(i) the blood test device according to claim 1; and

(ii) a measurement device for non-invasively measuring one or more body parameters.

16. A system according to claim 15, wherein the measurement device is configured and operable for non-invasive measurement of a blood glucose.

17. A system according to claim 15, wherein the measurement device comprises a ring-shaped sensor.

18. A system according to claim 17, wherein the ring-shaped sensor is adapted to be placed on the finger in addition to a finger holding element for use in the blood test.

19. A system according to claim 15, wherein the measurement device comprises a finger encompassing element for applying pressure to the finger.