Method and apparatus for repositioning a percutaneous probe

• US 6,529,776 B1
• Filed: 09/21/2000
• Issued: 03/04/2003
• Est. Priority Date: 12/01/1999
• Status: Expired due to Fees

• Current Assignee: Meagan Medical, Inc.
• Original Assignee: Vertis Neuroscience, Inc. (Northstar Neuroscience, Inc.)
• Inventors: Leonard, Paul C., Bishay, Jon M.
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US09/666,931
• Time in Patent Office: 894 Days
• Field of Search: 607/115, 607/116, 607/117, 600/373, 600/372, 600/382
• US Class Current: 607/116
• 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. The support housing can include a first guide extending axially away from the engaging surface and a second guide extending transverse to the first guide. The apparatus can further include a probe coupled to a guide member with the guide member sequentially engaged with the first guide and the second guide to move in a first direction toward and away from the engaging surface without simultaneously moving in a second direction transverse to the first direction. Accordingly, a practitioner can reposition the probe from one location to the other (for example, by orbiting the probe relative to a central axis of the support body, or by translating the probe linearly relative to the support body) without moving the housing relative to the skin surface.

Claims

1. A method for operating a percutaneous probe, comprising:

engaging a housing coupled to the probe with a selected location on a surface of a section of skin;

inserting the probe into the skin at a first position on the surface of the skin; and

withdrawing the probe from the first position and reinserting the probe into the skin at a second position on the surface of the skin by moving the probe relative to the housing while the housing remains in the selected location.

2. The method of claim 1, further comprising:

moving the probe in a first direction relative to the housing and away from the skin without moving the probe in a second direction relative to the housing and aligned with the skin; and

moving the probe in the second direction relative to the housing without moving the probe in the first direction relative to the housing.

3. The method of claim 1 wherein moving the probe relative to the housing includes orbiting the probe about an axis offset from a central axis of the housing.

4. The method of claim 1 wherein moving the probe relative to the housing includes moving the probe along a straight line in a plane aligned with and offset from the surface of the skin.

5. The method of claim 1 wherein the housing includes a plurality of channels and wherein the method further comprises halting movement of probe relative of the housing by inserting into one of the channels a tab coupled to the probe.

6. The method of claim 1, further comprising receiving mechanical feedback when the probe has moved from a first predetermined point relative to the housing to a second predetermined point relative to the housing.

7. The method of claim 1, further comprising:

overcoming a first level of mechanical resistance by moving the probe toward the skin to a first position with the probe spaced apart from the skin; and

moving the probe from the first position to a second position closer to the skin than the first position against a second level of mechanical resistance that is less than the first level of mechanical resistance.

8. The method of claim 1, further comprising overcoming mechanical resistance to move the probe from a first point where the probe is restricted from moving toward the skin to a second point where the probe can move freely toward the skin.

9. The method of claim 1, further comprising preventing movement of the probe from the first position to the second position while the probe is inserted in the skin.

10. The method of claim 1, further comprising releasably adhering the housing to the surface of the skin.

11. The method of claim 1 wherein the probe is an electrode and wherein inserting the probe includes inserting the electrode at a first position relative to a target nerve region beneath the skin, and wherein the method further comprises coupling the electrode to a source of electrical power to apply electrical stimulation to a region adjacent to the electrode.

12. The method of claim 1, further comprising simultaneously controlling an angle of entry of the probe into the skin while inserting the probe into the skin.

13. A method for operating a percutaneous electrode, comprising:

aligning with an external surface of a section of skin a housing that supports the percutaneous electrode;

engaging the housing with the surface of the skin;

inserting the electrode into the skin at a first position;

withdrawing the electrode from the skin by moving the electrode only in a direction generally normal to the surface of the skin while maintaining the housing in an approximately constant location relative to the skin;

rotating the electrode relative to the housing from the first position to a second position spaced apart from the first position without engaging the electrode with the surface of the skin; and

reinserting the electrode into the skin at the second position.

14. The method of claim 13 wherein the electrode is coupled to a guide member that is received in a housing channel extending away from the skin, and further wherein withdrawing the electrode includes moving the guide member away from the skin in the channel.

15. The method of claim 13 wherein the electrode is coupled to a locator tab, and wherein rotating the electrode relative to the housing includes rotating the locator tab from a first channel of the housing to a second channel of the housing spaced apart from the first channel.

16. The method of claim 13 wherein the housing includes an axial restriction having a first side facing away from the skin and a second side facing toward the skin and the electrode is coupled to a guide member having a portion adjacent to the first side of the axial restriction, and wherein reinserting the electrode includes moving the guide member from the first side of the axial restriction to the second side of the axial restriction.

17. The method of claim 13, further comprising coupling the electrode to a source of electrical power to apply electrical stimulation to a region adjacent to the electrode.

18. The method of claim 13, further comprising at least inhibiting rotation of the electrode relative to the housing while the electrode is inserted into the skin.

19. A method for treating a patient with percutaneous electrical stimulation, comprising:

releasably attaching a percutaneous electrode housing to an external surface of a section of skin;

positioning a guide member of a slider that supports the electrode at least partially within a first axial channel of a sleeve within the housing;

inserting the electrode into the skin at a first selected position relative to a target nerve region beneath the skin by engaging the slider with a plunger and moving the slider and the plunger together toward the skin with the guide member of the slider in the first axial channel of the sleeve and a peg of the plunger in a first axial channel of the housing, the first axial channel of the housing being coextensive with the first axial channel of the sleeve;

withdrawing the electrode from the skin in a direction generally normal to the external surface of the skin by sliding the slider away from the skin while maintaining the housing at an approximately constant position relative to the skin and while at least restricting transverse movement of the electrode relative to the surface of the skin;

orbiting the electrode about a central axis of the housing from the first selected position to a second selected position spaced apart from the first selected position without moving the electrode toward or away from the skin by rotating the sleeve, the slider, the electrode and the plunger together as a unit relative to the housing until the peg of the plunger is positioned within a second axial channel of the housing;

reinserting the electrode into the skin at the second selected position by sliding the slider member toward the skin; and

applying electrical power to the electrode.

20. The method of claim 19 wherein the sleeve has a sleeve tab and rotating the sleeve includes disengaging the sleeve tab from one axial channel in the housing and reinserting the sleeve tab in another axial channel of the housing.

21. A method for manufacturing a device for penetrating skin, comprising:

positioning a probe in a slider member;

disposing the slider member in a cavity of a housing with the probe being generally parallel to and offset from a major axis of the cavity and the slider member being slideable relative to the housing along an axis aligned with the probe; and

at least restricting motion of the slider member out of the cavity by at least restricting rotational motion of the slider member in one direction relative to the housing.

22. The method of claim 21 wherein the housing includes a first portion defining a first portion of the cavity and is pivotably coupled to a second portion defining a second portion of the cavity, and wherein the method further comprises positioning the slider member between the first and second portions of the housing and pivoting at least one of the first and second portions of the housing toward the other to receive a first part of the slider member in the first portion of the cavity and receive a second part of the slider member in the second portion of the cavity.

23. The method of claim 21 wherein the housing includes two internal ramped stop members, each stop member having an inclined surface with a first end and a second end, each stop member further having a stop surface extending away from the second end of the inclined surface, and wherein the method further comprises:

engaging first and second guide tabs of the slider member with the first ends of the inclined surfaces of the ramps;

rotating the slider member relative to the housing to move the first and second guide tabs along the inclined surfaces of the ramps; and

further rotating the slider member relative to the housing to move each tab beyond the second end of one of the inclined surfaces with each tab facing one of the stop surfaces.

24. A method for manufacturing a device for penetrating skin, comprising:

positioning a probe in a slider member;

positioning slider member between first and second pivotably coupled portions of a housing body, the first portion of the housing body having a first cavity and the second portion of the housing body having a second cavity; and

pivoting at least one of the first and second portions of the housing body toward the other to receive a first part of the slider member in the first cavity and receive a second part of the slider member in the second cavity.

25. The method of claim 24, further comprising fixedly positioning the probe along an axis generally parallel to and offset from a major axis of the housing body.

26. The method of claim 24, further comprising at least restricting motion of the slider out of the cavity by at least restricting rotational motion of the slider in one direction relative to the housing body.

27. An apparatus for piercing a skin surface, comprising:

a support housing having a casing defining an axial direction and an engaging surface to engage the skin surface at one end of the casing; and

a probe moveably supported relative to the support housing and moveable relative to the support housing in an axial direction toward and away from the engaging surface between a first position a first distance from the engaging surface and a second position a second distance from the engaging surface greater than the first distance, and the probe being moveable transverse to the axial direction relative to the support housing only when the probe is in the second position.

28. The apparatus of claim 27 wherein the probe is supported by a slider member having at least one guide portion, further wherein the support housing has at least one axial channel coupled to at least one transverse channel, the guide portion being received in the axial channel to move toward and away from the engaging surface, the guide portion being sequentially received in the transverse channel to move transverse to the engaging surface.

29. The apparatus of claim 27 wherein the probe includes an electrode coupleable to a source of electrical power.

30. The apparatus of claim 27 wherein the support housing includes:

a base having the engagement surface and a receiving cylinder projecting away from the engagement surface along a central axis, the receiving cylinder having an inner surface and a plurality of axial channels in the inner surface; and

a sleeve positioned within the receiving cylinder, the sleeve having at least one tab projecting into a corresponding one of the axial channels in the cylinder, the sleeve further having an internal cavity elongated along the central axis, the sleeve being rotatable relative to the base about the central axis and having a plurality of sleeve channels coextensive with the axial channels of the base.

31. An apparatus for piercing a skin surface, comprising:

a support housing having an engaging surface to engage a surface of a section of skin, the support housing having a first guide extending axially away from the engaging surface and a second guide extending transverse to the first guide; and

a probe coupled to a guide member, the guide member sequentially engaged with the first guide and the second guide to move in a first direction toward and away from the engaging surface without simultaneously moving in a second direction transverse to the first direction, and move in the second direction without simultaneously moving in the first direction.

32. The apparatus of claim 31 wherein the probe includes an electrode coupleable to a source of electrical power.

33. The apparatus of claim 31 wherein the first guide includes a first channel, the second guide includes a second channel, and the guide member is slideably received sequentially in the first and second channels.

34. The apparatus of claim 31 wherein the support housing includes:

a base having the engagement surface and a receiving cylinder projecting away from the engagement surface along a central axis, the receiving cylinder having an inner surface and a plurality of axial channels in the inner surface; and

a sleeve positioned within the receiving cylinder, the sleeve having at least one tab projecting into a corresponding one of the axial channels in the cylinder, the sleeve further having an internal cavity elongated along the central axis, the sleeve being rotatable relative to the base about the central axis and having a plurality of sleeve channels coaxial with the axial channels of the base.

35. A replaceable cartridge for use with a plunger having an electrical contact for administering percutaneous electrical stimulation, comprising:

a support housing having a generally flat engagement surface to engage a section of skin, the support housing further having a receiving cylinder projecting away from the engagement surface along a first axis;

a slider member positioned within the receiving cylinder and having at least one plunger engaging surface to removably engage the plunger; and

an electrode projecting away from the slider member along a second axis offset from and at least approximately parallel to the first axis, the electrode being coupleable to the electrical contact of the plunger.

36. The apparatus of claim 35 wherein the support housing includes:

a base having the engagement surface and a receiving cylinder projecting away from the engagement surface along a central axis, the receiving cylinder having an inner surface and a plurality of axial channels in the inner surface; and

a sleeve positioned within the receiving cylinder, the sleeve having at least one tab projecting into a corresponding one of the axial channels in the cylinder, the sleeve further having an internal cavity elongated along the central axis, the sleeve being rotatable relative to the base about the central axis and having a plurality of sleeve channels coaxial with the axial channels of the base.

37. An apparatus for providing percutaneous electrical stimulation, comprising:

a base having a generally flat engagement surface to engage the skin of a recipient, the base further having a receiving cylinder projecting away from the engagement surface along a first axis, the receiving cylinder having an inner surface and a plurality of axial channels in the inner surface;

a sleeve positioned within the receiving cylinder, the sleeve having at least one tab projecting into a corresponding one of the axial channels in the cylinder, the sleeve further having an internal cavity elongated along the first axis, the sleeve being rotatable relative to the base about the first axis, the sleeve further having two transverse channel portions, each transverse channel portion being proximate to a first axial stop member and a first rotational stop member, each transverse channel portion being coupled to an axial channel portion aligned with one of the axial channels of the base;

a slider positioned within the internal cavity of the sleeve, the slider having an electrode aperture aligned with a second axis that is parallel to and offset from the first axis, the slider further having two slots extending circumferentially about the first axis, the slider still further having a second axial stop member to engage the first axial stop member of the sleeve and a second rotational stop member to engage the first rotational stop member of the sleeve;

an electrode positioned within the electrode aperture of the slider and projecting away from the slider along the second axis, the electrode being coupleable to a source of electrical power; and

a plunger elongated along the first axis and having two plunger pegs, each plunger peg extending radially outwardly through one of the slots of the slider to engage the slider and drive the slider axially relative to the sleeve between a retracted position with the electrode positioned within the receiving cylinder and an extended position with the electrode projecting from the receiving cylinder beyond the base, each plunger peg further extending radially outwardly into one of the axial channels of the sleeve, with the plunger, the slider and the sleeve being rotatable as a unit about the first axis to orbit the electrode about the first axis, each plunger peg still further extending radially outwardly into one of the axial channels of the base.

38. The apparatus of claim 37 wherein the sleeve has a retaining groove transverse to the first axis and the sleeve has a lip received in the retaining groove to at least restrict axial motion of the sleeve relative to the base.

39. An apparatus for delivering percutaneous electrical stimulation, comprising:

a support housing having an engaging surface to engage a surface of a section of skin, the support housing having a first guide extending axially away from the engaging surface and a second guide extending transverse to the first guide;

an electrode having a sharp end and coupled to a guide member, the guide member having an engaging portion sequentially engaged with the first guide and the second guide to move in a first direction toward and away from the engaging surface without simultaneously moving in a second direction transverse to the first direction, and move in the second direction without simultaneously moving in the first direction;

an electrical contact releasably coupled to the electrode;

an electrical power source; and

an electrical link coupled between the electrical power source and the electrical contact.

40. The apparatus of claim 39 wherein the first guide includes an axial channel, the second guide includes a transverse channel and the guide member is sequentially received in the first and second channels.