Method and apparatus for deploying a percutaneous probe

• US 6,904,324 B2
• Filed: 08/11/2001
• Issued: 06/07/2005
• Est. Priority Date: 12/01/1999
• Status: Expired due to Fees

• Current Assignee: Meagan Medical, Inc.
• Original Assignee: Meagan Medical, Inc.
• Inventors: Bishay, Jon M.
• Primary Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US09/928,044
• Publication Number:
  US 20030195599A1
• Time in Patent Office: 1,396 Days
• Field of Search: 607/115, 607/116, 607/149, 600/372, 600386-392, 606/129
• US Class Current: 607/149
• CPC Class Codes: A61N 1/0502 Skin piercing electrodes
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36021 for treatment of pain

Abstract

An apparatus for piercing a skin surface, and methods for operating and manufacturing such an apparatus. In one embodiment, the apparatus can include a support housing having an engaging surface to engage the skin surface. A releasable attachment member can releasably secure the housing to the skin surface, for example, with an adhesive bond. A stop member can operatively engage a percutaneous probe of the apparatus to at least restrict the ability of the probe to be re-used.

Claims

1. An apparatus for administering percutaneous electrical therapy to a recipient, comprising:

a percutaneous electrode;

a housing supporting the percutaneous electrode in position for penetrating a skin surface of the recipient; and

a releasable attachment member having a first portion connected to the housing, the attachment member further having a second portion with an attachment surface facing away from the housing and adapted to engage the skin surface, a releasable bond coupling the second portion to the first portion wherein the releasable bond strength is less than a tear strength of the first portion and less than a tear strength of the second portion, and wherein the first and second portions of the attachment member are formed integrally with each other, and wherein the releasable bond includes perforations between the first and second portions.

2. The apparatus of claim 1 wherein the releasable bond includes a plurality of connecting portions arranged along a line between the first and second portions, the connecting portions being separated by interstitial spaces.

3. The apparatus of claim 1 wherein the releasable bond includes a plurality of connecting portions arranged along a line between the first and second portions, the connecting portions being separated by interstitial spaces, the connecting portions being formed integrally with the first and second portions of the attachment member.

4. The apparatus of claim 1 wherein the attachment member includes a plurality of layers, the first portion having a first plurality of layers, the second portion having a second plurality of layers, and the releasable bond having a third plurality of layers with the third plurality being less than the first plurality and less than the second plurality.

5. The apparatus of claim 1 wherein the first portion includes a first material, the second portion includes a second material and the releasable bond includes a third material different than the first and second materials.

6. The apparatus of claim 5 wherein the first and second materials are the same.

7. The apparatus of claim 1 wherein the housing includes a generally cylindrical portion in which the percutaneous electrode is positioned, the housing further including a flange extending radially outwardly from the generally cylindrical portion toward one end of the generally cylindrical portion, and wherein the first portion of the attachment member is adhesively bonded to the flange and the second portion of the attachment member is positioned radially outwardly from the first portion.

8. The apparatus of claim 1 wherein the first and second portions are formed integrally with each other and have a first thickness in a direction generally normal to the engaging surface, and wherein the releasable bond is formed integrally with the first and second portions and has a second thickness in a direction generally normal to the engaging surface, the second thickness being less than the first thickness.

9. The apparatus of claim 1 wherein the housing has a generally cylindrical portion and the releasable band defines a generally arcuate bond line concentric with the generally cylindrical portion.

10. The apparatus of claim 1 wherein the second portion of the attachment member includes a tab having a non-adhesive surface to remain detached from the skin surface when the attachment surface of the attachment member is engaged with the skin surface.

11. The apparatus of claim 1 wherein the second portion of the attachment member includes a tab having a non-adhesive surface to remain detached from the skin surface when the attachment surface of the attachment member is engaged with the skin surface, the non-adhesive surface being generally co-planar with an adhesive surface.

12. The apparatus of claim 1 wherein the attachment surface includes an adhesive to attach to the skin surface when the attachment surface is engaged with the skin surface.

13. The apparatus of claim 12, further comprising a cover sheet releasably attached to the adhesive.

14. The apparatus of claim 1 wherein the attachment member includes a compressible material on the first and second portions whereby the compressible material is utilized on the second portion of the attachment member when connected to the housing and the first portion.

15. The apparatus of claim 1, wherein the percutaneous electrode is movable relative to the housing between a first position with the percutaneous electrode located within the housing and a second position with the percutaneous electrode at least partially external to the housing for penetrating the skin surface, and wherein the apparatus still further comprises a stop member coupled to the housing and movable relative to the housing between a non-restricting position and restricting position, the stop member being operatively decoupled from the percutaneous electrode when in the non-restricting position to allow axial motion of the electrode, the stop member being positioned to at least restrict axial motion of the percutaneous electrode when the stop member is in the restricting position.

16. The apparatus of claim 1 wherein the housing has a generally cylindrical casing with an aperture extending through the casing, and wherein the housing has at least one guide channel, and wherein the apparatus further comprises:

a slider member supporting the percutaneous electrode and having at least one guide portion received in the guide channel, the slider member being movable relative to the housing to move the percutaneous electrode between a first position with the percutaneous electrode located within the housing and a second position with the percutaneous electrode at least partially external to the housing for penetrating the skin surface; and

a stop member connected to the attachment member and movable relative to the housing between a non-restricting position and a restricting position, the stop member being disengaged from the slider member when in the non-restricting position to allow axial motion of the electrode between the first and second positions, the stop member being axially aligned with the slider member when in the restricting position to at least restrict motion of the percutaneous electrode away from the second position, the stop member having a tab portion positioned and adapted to be engaged by a human digit for movement between the non-restricting and the restricting position, the stop member further including an engaging portion positioned in the aperture of the casing, the engaging portion being generally co-planar with the casing when the stop member is in the non-restricting position, the engaging portion being positioned inwardly of the casing and aligned with the slider member when the stop member is the restricting position.

17. An apparatus for administering percutaneous electrical therapy to a recipient, comprising:

a support housing having an engaging surface positioned and adapted to engage a skin surface of the recipient;

a percutaneous electrode movably supported relative to the support housing and movable relative to the support housing toward and away from the engaging surface between a first position with the electrode a first distance from the engaging surface and a second position with the electrode a second distance away from the engaging surface; and

an adhesive member having a first portion connected to the support housing, the adhesive member further having a second portion with an adhesive surface facing away from the housing and adapted to engage the skin surface, a releasable bond coupling the second portion to the first portion and wherein releasable bond strength is less than the first portion strength and less than the second portion strength, with the adhesive member preferentially separating at the releasable bond when a first force is applied to the first portion and a second force at least partially opposing the first force is applied to the second portion.

18. The apparatus of claim 17, wherein the first and second portions of the adhesive member are formed integrally with each other and wherein the releasable bond includes perforations between the first and second portions.

19. The apparatus of claim 17 wherein the releasable bond includes a plurality of connecting portions arranged along a line between the first and second portions, the connecting portions being separated by interstitial spaces.

20. The apparatus of claim 17 wherein the releasable bond includes a plurality of connecting portions arranged along a line between the first and second portions, the connecting portions being separated by interstitial spaces, the connecting portions being formed integrally with the first and second portions of the adhesive member.

21. The apparatus of claim 17 wherein the support housing includes a generally cylindrical portion in which the percutaneous electrode is positioned, the housing further including a flange extending radially outwardly from the generally cylindrical portion toward one end of the generally cylindrical portion, the flange carrying the engaging surface, and wherein the first portion of the attachment member is adhesively bonded to the flange and the second portion of the adhesive member is positioned radially outwardly from the first portion.

22. The apparatus of claim 17 wherein the second portion of the adhesive member includes a tab having a non-adhesive surface to remain detached from the skin surface when the adhesive surface of the attachment member is attached to the skin surface.

23. The apparatus of claim 17, further comprising a stop member coupled to the housing and moveable relative to the housing between a non-restricting position and a restricting position, the stop member being operatively decoupled from the percutaneous electrode when in the non-restricting position to allow axial motion of the electrode between the first and second positions, the stop member being positioned to at least restrict motion of the percutaneous electrode away from the second position when the stop member is in the restricting position.

24. An apparatus for administering percutaneous electrical therapy to a recipient, comprising:

a support housing having an engaging surface positioned and adapted to engage a skin surface of the recipient;

a percutaneous electrode movably supported relative to the support housing and movable relative to the support housing along an axis towards and away from the engaging surface between a first position with the electrode a first distance from the engaging surface and a second position with the electrode a second distance away from the engaging surface, the electrode being movable transverse to the axis relative to the support housing only when the probe is in the second position; and

an adhesive member having a first portion connected to the support housing, the adhesive member further having a second portion with an adhesive surface facing away from the housing and adapted to engage the skin surface, a releasable bond coupling the second portion to the first portion and wherein the releasable bond strength is less than the first portion strength and less than the second portion strength, with the adhesive member preferentially separating at the releasable bond when opposing forces are applied to the first and second portions.

25. The apparatus of claim 24 wherein the first and second portions of the adhesive member are formed integrally with each other and wherein the releasable bond includes perforations between the first and second portions.

26. The apparatus of claim 24 wherein the support housing includes a generally cylindrical portion in which the percutaneous electrode is positioned, the housing further including a flange extending radially outwardly from the generally cylindrical portion toward one end of the generally cylindrical portion, the flange carrying the engaging surface, and wherein the first portion of the attachment member is adhesively bonded to the flange and the second portion of the adhesive member is positioned radially outwardly from the first portion.

27. The apparatus of claim 24 wherein the second portion of the adhesive member includes a tab having a non-adhesive surface to remain detached from the skin surface when the adhesive surface of the adhesive member is attached to the skin surface.

28. The apparatus of claim 24, further comprising a stop member coupled to the housing and moveable relative to the housing between a non-restricting position and a restricting position, the stop member being operatively decoupled from the percutaneous electrode when in the non-restricting position to allow axial motion of the electrode between the first and second positions, the stop member being positioned to at least restrict motion of the percutaneous electrode away from the second position when the stop member is in the restricting position.

29. The apparatus of claim 24 wherein the housing has a base and a receiving cylinder, and wherein the apparatus further comprises:

a sleeve positioned in the receiving cylinder and rotatable about the axis; and

a slider member supporting the percutaneous electrode in a position parallel to and offset from the axis, the slider member being slideable relative to the sleeve and the housing along the axis.

30. An apparatus for administering percutaneous electrical therapy to a recipient comprising:

a percutaneous electrode;

a housing supporting a percutaneous electrode in position for penetrating the skin surface of the recipient; and

a removable attachment member initially separate from the housing, the attachment member having a first portion with an adhesive upper surface positioned to adhere to the housing, the attachment member further having a second portion with an adhesive lower surface facing away from the upper surface and adapted to engage the skin surface, a releasable bond coupling the second portion to the first portion, and wherein a tear strength of the releasable bond is less than a tear strength of the first portion and less than a tear strength of the second portion.

31. The apparatus of claim 30 wherein the upper surface has a first adhesive and the lower surface has a second adhesive, the first adhesive being configured to form a first bond with the housing, the second adhesive being configured to form a second bond with the skin surface, the second bond being weaker than the first bond.

32. The apparatus of claim 30, further comprising a first releasable cover removably attached to the upper surface and a second releasable cover removably attached to the second surface.

33. The apparatus of claim 30 wherein the first and second portions of the attachment member are formed integrally with each other and wherein the releasable bond includes perforations between the first and second portions.

34. The apparatus of claim 30 wherein the support housing includes a generally cylindrical portion in which the percutaneous electrode is positioned, the housing further including a flange extending radially outwardly from the generally cylindrical portion towards one end of the generally cylindrical portion, and wherein the first portion of the attachment member is shaped to adhesively bond to the flange and the second portion of the attachment member is positioned radially outwardly from the first portion.

35. The apparatus of claim 30 wherein the housing has a generally cylindrical portion and the releasable bond defines a generally arcuate bond line concentric with the generally cylindrical portion.

36. The apparatus of claim 30, further comprising the percutaneous electrode, and wherein the percutaneous electrode is movable relative to the housing between a first position with the percutaneous electrode located within the housing and a second position with the percutaneous electrode at least partially external to the housing to penetrate he skin surface, and wherein the apparatus still further comprises a stop member coupled to the housing and moveable relative to the housing between a non-restricting position and a restricting position, the stop member being operatively decoupled from the percutaneous electrode when in the non-restricting position to allow axial motion of the electrode, the stop member being positioned to at least restrict axial motion of the percutaneous electrode when the stop member is in the restricting position.