System for withdrawing blood

• US 9,839,387 B2
• Filed: 01/21/2014
• Issued: 12/12/2017
• Est. Priority Date: 10/31/2000
• Status: Expired due to Term

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Fritz, Michael, Sacherer, Klaus-Dieter, List, Hans, Weiss, Thomas, Deck, Frank, Immekus, Claudio
• Primary Examiner(s): TANNER, JOCELIN C
• Application Number:
  US14/159,979
• Publication Number:
  US 20140135808A1
• Time in Patent Office: 1,421 Days
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150183 Depth adjustment mechanism using end caps mounted at the distal end of the sampling device, i.e. the end-caps are adjustably positioned relative to the piercing device housing for example by rotating or screwing
• 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 5/150549 Protectors removed by rotational movement, e.g. torsion or screwing
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150618 Integrally moulded protectors, e.g. protectors simultaneously moulded together with a further component, e.g. a hub, of the piercing element
• CPC Class Codes: A61B 5/150717 manually removed
• 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 5/15153 Multiple piercing elements stocked in a single compartment
• CPC Class Codes: A61B 5/15163 Characterized by propelling the piercing element in an axial direction relative to the disc
• CPC Class Codes: A61B 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/15194 fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin

Abstract

The present invention includes a system for withdrawing body fluids. The system includes a drive unit having a plunger which is moved from a resting position into a lancing position in order to carry out a lancing process and a lancing unit containing a lancet with a needle. The plunger and lancet are coupled together by a form fit in order to carry out a lancing process. The invention additionally concerns a method for temporarily extending a needle from a device for withdrawing body fluid as well as a lancing unit that can be attached to the drive unit.

Claims

1. A lancing unit, comprising:

a plurality of lancets, wherein each of the plurality of lancets includes a needle and a needle tip, wherein the needle tip is embedded in an elastomer before a puncture, and wherein the elastomer is pierced by the needle during a puncture process in order to free the needle tip, characterized in that the elastomer remains on the needle when the lancet is at a fully retracted position and the needle tip is exposed at the fully retracted position; and

a magazine containing the plurality of lancets which can be successively coupled to a plunger of a drive unit.

2. Lancing unit according to claim 1, characterized in that the elastomer tightly surrounds the needle tip.

3. Lancing unit according to claim 1, characterized in that the elastomer is selected from the group comprising styrene-oligoblock copolymers, thermoplastic polyolefins, thermoplastic polyurethanes, thermoplastic copolyesters and thermoplastic copolyamides.

4. Lancing unit according to claim 1, characterized in that each of the plurality of lancets has a base body made of plastic in which a metal needle is located.

5. Lancing unit according to claim 1, characterized in that each of the plurality of lancets has a holding device with holding elements to make a form-fitting connection with a plunger of a drive unit.

6. Lancing unit according to claim 1 as well as a housing in which the at least one of the plurality of lancets is arranged in a resting position.

7. Lancing unit according to claim 6, characterized in that the lancing unit contains a sleeve, wherein the lancet is capable of being moved in the sleeve.

8. Lancing unit according to claim 7, characterized in that an underside of the sleeve has a plate with a central opening wherein the plate prevents the elastomer from emerging through the opening so that the said elastomer is pierced when the needle emerges through the central opening.

9. System for withdrawing body fluid comprising

a drive unit having a plunger which is moved from a resting position into a lancing position in order to carry out a lancing process and

a lancing unit including

a plurality of lancets, wherein each of the plurality of lancets includes a needle and a needle tip, wherein the needle tip is embedded in an elastomer before a puncture and wherein the elastomer is pierced by the needle during a puncture process in order to free the needle tip, characterized in that the elastomer remains on the needle when the lancet is at a fully retracted position and the needle tip is exposed at the fully retracted position,

a magazine containing the plurality of lancets which can be successively coupled to the plunger of the drive unit, and

where each of the plurality of lancets is arranged within the lancing unit in the resting position of the plunger and is displaced by the plunger when the plunger moves into the lancing position in such a manner that the needle at least partially emerges through an exit opening in the lancing unit.

10. System according to claim 9, characterized in that the plunger and lancet are coupled together by a form fit in order to carry out the lancing process.

11. System according to claim 9, characterized in that the plunger has a holding area which is held in a form fitting manner on the lancet by a holding device.

12. System according to claim 9, in which the lancing unit is detachably attached to the drive unit.

13. System according to claim 9, wherein:

the lancet includes at least one holding element configured to move transversely to a direction the plunger moves in order to carry out the lancing process; and

the plunger and the holding element are decoupled when at the resting position.

14. System according to claim 13, further comprising:

a sleeve in which the lancet is disposed; and

wherein the holding element has a shoulder configured to retain the needle tip within the sleeve when the lancet is retracted and the needle tip is exposed.

15. Method for temporarily extending a first needle out of a device for withdrawing body fluid, comprising the steps

coupling the first needle of a plurality of needles contained in a magazine to a plunger of a drive unit, wherein each of the plurality of needles has a needle tip embedded in an elastomer before the puncture;

carrying out a puncture with the plunger during which the elastomer is pierced by the first needle;

retracting the needle to a fully retracted position with the plunger during which the elastomer remains on the needle and the needle tip is exposed in the fully retracted position; and

coupling a second needle of the plurality of needles contained in the magazine to the plunger.

16. Method according to claim 15, comprising the steps

wherein said coupling the first needle includes coupling the first needle to the plunger of the drive unit in a form-fitting manner, wherein either the plunger has a holding area and the first needle has a holding device, or the first needle has a holding area and the plunger has a holding device,

moving the plunger from a resting position in which the first needle is arranged within the magazine of a lancing unit into a position in which the first needle emerges from an exit opening of the magazine of the lancing unit, and

retracting the plunger in order to pull the first needle back into the magazine of the lancing unit.

17. Method for temporarily extending a needle from a device for withdrawing body fluid, comprising:

coupling a lancet to a plunger of a drive unit in a form-fitting manner, wherein the lancet is one of a plurality contained in a magazine which can be successively coupled to the plunger of the drive unit, where either the plunger has a holding area and the lancet has a holding device or the lancet has a holding area and the plunger has a holding device,

moving the plunger from a resting position in which the needle of the lancet is located inside a lancing unit into a position in which the needle emerges from an exit opening of the lancing unit, wherein at least one holding element of the holding device is moved transversely to the longitudinal direction by means of a longitudinal movement of the holding device during said moving the plunger from the resting position such that at least one holding element at least partially closes around the holding area, and

moving the plunger back in order to retract the needle into the lancing unit.

18. Method as claimed in claim 17, in which the lancet is coupled to the drive unit by attaching the lancing unit to the drive unit.

19. Method as claimed in claim 17, in which the lancet and plunger are disconnected by removing the lancing unit from the drive unit.

20. Method as claimed in claim 17, wherein:

the lancet has a needle with a needle tip which is located in an elastomer before a puncture;

said moving the plunger from the resting position includes carrying out the puncture during which the elastomer is pierced by the needle; and

said moving the plunger back includes retracting the lancet during which the elastomer remains on the needle and the needle tip is exposed.

21. Method as claimed in claim 20, further comprising:

wherein the holding device includes at least one holding element; and

coupling at least one holding element with the holding area by moving the at least one holding element in a transverse direction during said moving the plunger from the resting position.

22. Method as claimed in claim 21, further comprising:

decoupling the at least one holding element from the holding area after said moving the plunger back; and

retaining the needle tip in the lancing unit by engaging a shoulder of the at least one holding element with the lancing unit.

23. System for withdrawing body fluid comprising:

a drive unit having a plunger which is moved from a resting position into a lancing position in order to carry out a lancing process;

a lancing unit in which a lancet with a needle is located, wherein the lancet includes a needle and a needle tip, wherein the needle tip is embedded in an elastomer before a puncture and wherein the elastomer is pierced by the needle during a puncture process in order to free the needle tip, characterized in that the elastomer remains on the needle when the lancet is at a fully retracted position and the needle tip is exposed at the fully retracted position, where the lancet is arranged within the lancing unit in the resting position of the plunger and is displaced by the plunger when the plunger moves into the lancing position in such a manner that the needle at least partially emerges through an exit opening in the lancing unit;

wherein the lancet includes at least one holding element configured to move transversely to a direction the plunger moves in order to carry out the lancing process;

wherein the plunger and the at least one holding element are decoupled when at the resting position;

a sleeve in which the lancet is disposed; and

wherein the at least one holding element has a shoulder configured to retain the needle tip within the sleeve when the lancet is retracted and the needle tip is exposed.