Sequential introduction of skin penetrators

• US 7,985,203 B2
• Filed: 08/30/2007
• Issued: 07/26/2011
• Est. Priority Date: 03/04/2005
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics International AG (Roche Holding AG)
• Inventors: Feldmann, Peter, Niederhauser, Sandro, Hof, Christian, Haueter, Ulrich
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): Eisenberg; Rebecca E
• Application Number:
  US11/847,857
• Publication Number:
  US 20080140009A1
• Time in Patent Office: 1,426 Days
• Field of Search: 600/365, 604159-162, 606181-183
• US Class Current: 604/158
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 2017/3492 against the outside of the body
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: A61B 5/6849 in combination with a needle set
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2005/1587 suitable for being connected to an infusion line after insertion into a patient
• CPC Class Codes: A61M 2039/0202 for taking samples
• CPC Class Codes: A61M 2039/0205 for injecting media
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body

Abstract

A device for facilitating the use or application of skin penetrators, the device including a puncturing part for piercing the skin, an indwelling part which can be introduced into the skin through an opening generated by the puncturing part and remains there, wherein the puncturing part and indwelling part are operably associated with the device, and a guide operably associated with the device, wherein, in use, the indwelling part is moved, via the guide, into a position of use after the puncturing part has pierced the skin. In some embodiments, the puncturing and indwelling parts are separate from each other prior to use. A method of using skin penetrators is encompassed and includes sequentially introducing the puncturing part and the indwelling part into the skin.

Claims

1. A device for application of skin penetrators, the device comprising:

a housing comprising a housing underside for contacting the skin, the housing underside having one or more openings therein;

a puncturing part for piercing the skin;

an indwelling part which can be introduced into the skin through an opening in the skin generated by the puncturing part and remains there;

a guide associated with the device; and

an elastic drive device adapted to drive the puncturing part into the skin;

wherein, in use, the indwelling part and the puncturing part are introduced into the skin sequentially such that the indwelling part is moved through one of the one or more openings in the housing underside after the puncturing part is moved through one of the one or more openings in the housing underside.

2. The device according to claim 1, wherein the puncturing part and the indwelling part are separate from each other and the device prior to use.

3. The device according to claim 1, wherein the housing carries the guide.

4. The device according to claim 3, wherein the guide comprises an abutment for contact by at least one of the puncturing part and the indwelling part, the abutment forming a hold point for at least one of the puncturing part and the indwelling part, wherein the puncturing part and the indwelling part are guided in the guide in an operable movement that brings the puncturing part into contact with the abutment thereby holding the puncturing part at the hold point, the operable movement then continuing to move the indwelling part into an indwelling use position.

5. A device for use in the use of skin penetrators, the device comprising a puncturing part, which pierces the skin to define an opening therein, an indwelling part, and an elastic drive device adapted to drive the puncturing part into the skin, wherein the indwelling part moves from an initial position to an indwelling position in which it is introduced into the skin through the opening generated by the puncturing part, wherein the puncturing part and indwelling part are provided separately on the device, and wherein the indwelling part moves relative to the puncturing part during movement from the initial position to the indwelling position, and at least one guide in or on which, after the puncturing part, the indwelling part is introduced into the skin through the opening.

6. The device according to claim 5, further comprising a housing in or on which the puncturing part and the indwelling part are arranged.

7. The device according to claim 6, further comprising a guide whereby the puncturing part and the indwelling part are introduced into the skin through the guide.

8. The device according to claim 7, further comprising a retaining member associated with the guide, said retaining member at least one of retaining the puncturing part in the retracted position and holding the coupled puncturing part and indwelling part in the in-use position of the indwelling part.

9. The device according to claim 7, further comprising a puncturing part receiver associated with at least one of the guide or the housing to receive and hold the puncturing part, after the puncturing part is moved from the puncture position.

10. The device according to claim 7, wherein the guide has a hold point assigned to at least one of a puncture position or an in-use position.

11. The device according to claim 10, wherein the hold point is formed by an abutment for at least one of the puncturing part and the indwelling part.

12. The device according to claim 11, wherein the puncturing part and the indwelling part are guided in the guide in a coupled movement, and the hold point is generated by an abutment onto which the puncturing part is guided after the puncturing procedure, thereby carrying the indwelling part into the in-use position.

13. The device according to claim 11, wherein the puncturing part and the indwelling part are received in a housing in which the guide and the abutment are accommodated, and the housing has a passage for the puncturing part and the indwelling part.

14. The device according to claim 10, wherein the hold point is formed by a locking engagement for the puncturing part and the indwelling part, the locking engagement being arranged in or on the guide.

15. The device according to claim 14, wherein a single releasable locking engagement is provided in or on the guide, into which first the puncturing part and thereafter the indwelling part can lock.

16. The device according to claim 5, wherein the puncturing part and the indwelling part are guided through different guides.

17. The device according to claim 5, wherein the guide is one of a curved guide, a linear guide or a combination curved and linear guide.

18. The device according to claim 5, wherein the indwelling part is made of a material that has a greater stiffness at ambient or room temperature than it does at body temperature.

19. The device according to claim 5, wherein the indwelling part is a sensor for measuring a physiological parameter.

20. The device according to claim 19, wherein the physiological parameter interstitial glucose concentration.

21. A device for application of skin penetrators, the device comprising:

a puncturing part for piercing the skin, wherein the puncturing part moves from an initial position to a puncturing position in which the puncturing part pierces the skin to define an opening therein, and from the puncturing position to a post-puncturing position in which the puncturing part is removed from the opening;

an indwelling part, wherein the indwelling part moves from an initial position to an indwelling position in which it is introduced into the skin through the opening generated by the puncturing part, wherein the puncturing part and indwelling part are spaced-apart from each other substantially throughout their respective movements into the skin, and the indwelling part moves relative to the puncturing part during movement from the initial position to the indwelling position;

a housing in or on which the puncturing part and the indwelling part are arranged, wherein in the initial position a distal end of the indwelling part is disposed above a bottom surface of the housing, and in the indwelling position the distal end of the indwelling part is disposed below the bottom surface of the housing;

a guide associated with the device, wherein the indwelling part is moved in or onto the guide after the puncturing part is moved in or onto the guide; and

an elastic drive device adapted to drive the puncturing part into the skin.

22. A device for application of skin penetrators, the device comprising:

a housing comprising a housing underside for contacting the skin, the housing underside having one or more openings therein;

a puncturing part for piercing the skin;

an indwelling part which can be introduced into the skin through an opening in the skin generated by the puncturing part and remains there,

a guide associated with the device, the guide comprising a guide slot for guiding the piercing part and the indwelling part into the skin and a receiver slot adapted to receive the puncturing part after its puncturing movement, wherein the receiver slot extends at an angle relative to the guide slot; and

wherein, in use, the indwelling part and the puncturing part are introduced into the skin sequentially such that the indwelling part is moved through the guide slot and one of the one or more openings in the housing underside after the puncturing part is moved through the guide slot and one of the one or more openings in the housing underside.

23. The device according to claim 22, further comprising an elastic drive device adapted to drive the puncturing part into the skin.

24. The device according to claim 23, wherein the guide slot and the receiver slot form a continuous path.