Sequential introduction of skin penetrators

• US 8,409,144 B2
• Filed: 06/20/2011
• Issued: 04/02/2013
• 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: Haueter, Ulrich, Niederhauser, Sandro, Feldmann, Peter, Hof, Christian
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): Eisenberg, Rebecca E
• Application Number:
  US13/164,072
• Publication Number:
  US 20110245774A1
• Time in Patent Office: 652 Days
• Field of Search: 604159-162, 600/365, 600181-183
• 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 method of introducing skin penetrators into skin, the method involving a device which comprises a puncturing part which pierces the skin, an indwelling part, wherein the indwelling part moves from an initial position to an indwelling position in which the indwelling part is introduced into the skin through an opening generated by the puncturing part and remains there, a guide with a guide slot for guiding the puncturing part and the indwelling part into the skin, and a drive device adapted to drive the puncturing part into the skin;

and said method comprises;

operating the device such that the indwelling part moves relative to the puncturing part during movement from the initial position to the indwelling position, and introducing the puncturing part and the indwelling part into the skin sequentially via the guide slot of the guide.

2. The method according to claim 1, wherein the guide comprises a receiver slot, and wherein the method comprises receiving the puncturing part after its puncturing movement in the receiver slot.

3. The method according to claim 2, wherein the method comprises extending the receiver slot at an angle relative to the guide slot.

4. The method according to claim 1, wherein the device further comprises a housing comprising a housing underside having one or more openings therein for contacting the skin, and the method comprises moving the indwelling part 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.

5. The method according to claim 4, wherein the method comprises arranging the puncturing part and the indwelling part in or on the housing.

6. The method according to claim 1, wherein the method further comprises driving the puncturing part into the skin with the drive device.

7. The method according to claim 1, comprising associating the puncturing part and the indwelling part separately with the device.

8. The method according to claim 1, 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, and wherein the method further comprises moving the puncturing part and the indwelling part 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.

9. The method according to claim 8, comprising operably coupling the puncturing part and the indwelling part during at least part of the operable movement.

10. The method according to claim 9, comprising guiding the puncturing part and the indwelling part through different guides.

11. The method according to claim 1, wherein in the device further comprises a retaining member associated with the guide, and wherein the method further comprises 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 of the retaining member.

12. A method of introducing skin penetrators into skin, the method involving a device which comprises a puncturing part, an indwelling part, at least one guide, and a drive device adapted to drive the puncturing part into the skin, said method comprising:

operating the drive device such that the puncturing part pierces the skin to define an opening therein, the indwelling part moves from an initial position to an indwelling position in which the indwelling part is introduced into the skin through the opening generated by the puncturing part, wherein the indwelling part moves relative to the puncturing part during movement from the initial position to the indwelling position, and which, after the puncturing part, the indwelling part is introduced into the skin through the opening in or on the at least one guide.

13. The method according to claim 12, comprising arranging in or on a housing the puncturing part and the indwelling part.

14. The method according to claim 13, wherein the method further comprises introducing both the puncturing part and the indwelling part into the skin guided in the guide.

15. The method according to claim 14, wherein the guide has a hold point assigned to at least one of a puncture position or an in-use position, and wherein the method comprises providing an abutment for at least one of the puncturing part and the indwelling part at the holding point.

16. The method according to claim 15, wherein the puncturing part and the indwelling part are guided in the guide in a coupling movement, and the method comprises generating the hold point by the abutment onto which the puncturing part is guided after the puncturing procedure, thereby carrying the indwelling part into the in-use position.

17. The method according to claim 15, comprising receiving the puncturing part and the indwelling part in the housing in which the guide and the abutment are accommodated, and the housing having a passage for the puncturing part and the indwelling part.

18. The method according to claim 13, wherein the device further comprises a puncturing part receiver associated with at least one of the guide or the housing, and wherein the method further comprises receiving and holding the puncturing part, after the puncturing part is moved from the puncture position.

19. The method according to claim 12, further comprises providing a locking engagement for the puncturing part and the indwelling part arranged in or on the guide.

20. The method according to claim 19, comprising locking first the puncturing part and thereafter the indwelling part in or on the guide forming a single releasable locking engagement.

21. A method of introducing skin penetrators into skin, comprising:

providing a device which comprises;

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 the indwelling part is introduced into the skin through the opening generated by the puncturing part,

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

a drive device adapted to drive the puncturing part into the skin;

applying the bottom surface of the device to the skin; and

operating the device to move the puncturing part via the drive device from the initial position to the puncturing position such that the puncturing part pierces the skin to define the opening and from the puncturing position to the post-puncturing position thereby removing the puncturing part from the opening, and

moving the indwelling part relative to the puncturing part from the initial position to the indwelling position, wherein respective movements of the puncturing part and indwelling part are substantially spaced-apart from each other throughout their respective movements into the skin.