U.S. patent application number 10/994372 was filed with the patent office on 2005-05-05 for apparatus and method for coupling therapeutic and/or monitoring equipment to a patient.
Invention is credited to Bishay, Jon M., Leonard, Paul C., Miazga, Jay M..
Application Number | 20050096717 10/994372 |
Document ID | / |
Family ID | 27036785 |
Filed Date | 2005-05-05 |
United States Patent
Application |
20050096717 |
Kind Code |
A1 |
Bishay, Jon M. ; et
al. |
May 5, 2005 |
Apparatus and method for coupling therapeutic and/or monitoring
equipment to a patient
Abstract
A method and apparatus for supporting couplers for therapy
administration and/or monitoring. The apparatus can include a
support member configured to rest on a body of a recipient
proximate to a coupling area. The support member can include a
first coupler location configured to removably carry a first
coupler proximate to a first coupling position of the body of the
recipient. A second coupler location of the support member is
configured to removably carry a second coupler proximate to a
second coupling position of the body of the recipient. The first
and second coupler locations can be arranged to guide the
practitioner to connect the couplers properly to the body. For
example, the first coupler location can be positioned closer than
the second coupler location to the first coupling position.
Accordingly, practitioners can be more likely to connect the first
and second couplers to the correct coupling position on the body of
the recipient.
Inventors: |
Bishay, Jon M.;
(Woodinville, WA) ; Leonard, Paul C.;
(Woodinville, WA) ; Miazga, Jay M.; (Seattle,
WA) |
Correspondence
Address: |
BLANK ROME LLP
600 NEW HAMPSHIRE AVENUE, N.W.
WASHINGTON
DC
20037
US
|
Family ID: |
27036785 |
Appl. No.: |
10/994372 |
Filed: |
November 23, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10994372 |
Nov 23, 2004 |
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09751382 |
Dec 29, 2000 |
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10994372 |
Nov 23, 2004 |
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09452477 |
Dec 1, 1999 |
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6622051 |
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10994372 |
Nov 23, 2004 |
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09666931 |
Sep 21, 2000 |
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6529776 |
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Current U.S.
Class: |
607/116 |
Current CPC
Class: |
A61N 1/0502 20130101;
A61N 1/36021 20130101; A61N 1/36017 20130101; A61N 1/0551
20130101 |
Class at
Publication: |
607/116 |
International
Class: |
A61N 001/00 |
Claims
1. An apparatus for supporting couplers for removable coupling to a
recipient during at least one of therapy administration and/or
recipient monitoring, the apparatus comprising a support member
configured to rest on a body of the recipient, the support member
having a first coupler portion configured to be positioned
proximate to a first coupling position of the body of the
recipient, the support member further having a second coupler
portion configured to be positioned proximate to a second coupling
position of the body of the recipient, the first coupler portion
being configured to removably carry a first coupler, wherein the
first coupler is movable relative to the first coupler portion
between a first carried position with the first coupler carried by
the first coupler portion and a first coupled position with the
first coupler operatively coupled to the recipient at the first
coupling position the second coupler portion being configured to
removably carry a second coupler, wherein the second coupler is
movable relative to the second coupler portion between a second
carried position with the second coupler carried by the second
coupler portion and a second coupled position with the second
coupler operatively coupled to the recipient at the second coupling
position, the support member being spaced apart from the first and
second coupling positions when resting on the body of the
recipient.
2. The apparatus of claim 4, further comprising: a first engagement
member depending from the support member at the first coupler
portion and configured to removably engage the first coupler; and a
second engagement member depending from the support member at the
second coupler portion and configured to removably engage the
second coupler.
3. The apparatus of claim 4, further comprising the first and
second couplers.
4. An apparatus for supporting couplers for removable coupling to a
recipient during at least one of therapy administration and
recipient monitoring, the apparatus comprising: a first coupler
having an electrical contact configured to be connected to a
percutaneous electrical probe inserted into the recipient; a
support member which aids in placement of the couplers on the
recipient, and is configured to rest on a body of the recipient,
the support member having a first coupler portion configured to be
positioned proximate to a first coupling position of the body of
the recipient and a second coupler portion configured to be
positioned proximate to a second coupling position of the body of
the recipient, the first coupler portion being configured to
removably carry the first coupler, the second coupler portion being
configured to removably carry a second coupler, the support member
being spaced apart from the first and second coupling positions
when resting on the body of the recipient; and a flexible cable
connected between the first coupler and the support member, the
cable remaining connected between the first coupler and the support
member when the first coupler is moved from a first carried
position with the first coupler carried by the first coupler
portion to a first coupled position with the first coupler
operatively coupled to the recipient.
5. The apparatus of claim 4, wherein the first coupler is
configured to transmit electrical signals to the recipient when the
first coupler is coupled to the recipient at the first coupled
position.
6. The apparatus of claim 4 wherein the support member is shaped to
rest on at least one of a back, a neck, a head and a leg of the
recipient.
7. The apparatus of claim 1 wherein the first and second coupler
portions are two of a larger plurality of coupler portions, wherein
each of the larger plurality of coupler portions are configured to
be positioned proximate to a corresponding one of a larger
plurality of coupling positions including the first and second
coupling positions, and further wherein an outline of the coupling
positions defines a first shape and an outline of the coupler
locations defines a corresponding second shape at least generally
similar to the first shape.
8. The apparatus of claim 4 wherein the first coupler portion is
positioned closer than the second coupler portion to the first
coupling position.
9. An apparatus for supporting couplers for removable coupling to a
recipient during at least one of therapy administration and
recipient monitoring, the apparatus comprising a support member
configured to rest on a body of the recipient, the support member
being elongated along a support member axis and having a first
coupler portion configured to be positioned proximate to a first
coupling position of the body of the recipient when the support
member rests on the body of the recipient, the support member
further having a second coupler portion configured to be positioned
proximate to a second coupling position of the body of the
recipient when the support member rests on the body of the
recipient, the first coupler portion being configured to removably
carry a first coupler, wherein the first coupler is movable
relative to the first coupler portion between a first carried
position with the first coupler carried by the first coupler
portion and a first coupled position with the first coupler
operatively coupled to the recipient at the first coupling
position, the second coupler portion being configured to removably
carry a second coupler, wherein the second coupler is movable
relative to the second coupler portion between a second carried
position with the second coupler carried by the second coupler
portion and a second coupled position with the second coupler
operatively coupled to the recipient at the second coupling
position, the first coupler portion being positioned closer than
the second coupler portion to the support member axis.
10. The apparatus of claim 9, further comprising: a first
engagement member depending from the support member at the first
coupler portion and configured to removably engage the first
coupler; and a second engagement member depending from the support
member at the second coupler portion and configured to removably
engage the second coupler.
11. The apparatus of claim 9, further comprising the first and
second couplers.
12. The apparatus of claim 9, further comprising: the first
coupler, wherein the first coupler has an electrical contact
configured to be connected to a percutaneous electrical probe
inserted into the patient; and a flexible cable connected between
the first coupler and the support member, the cable remaining
connected between the first coupler and the support member when the
first coupler is moved from the first carried position to the first
coupled position.
13. The apparatus of claim 9, further comprising the first coupler
and wherein the first coupler is configured to transmit electrical
signals to the recipient when the first coupler is coupled to the
recipient at the first coupling position.
14. The apparatus of claim 9 wherein the support member is shaped
to rest on at least one of a back, a neck, a head and a leg of the
recipient.
15. The apparatus of claim 9 wherein the first and second coupler
portions are two of a larger plurality of coupler portions, wherein
each of the larger plurality of coupler portions are configured to
be positioned proximate to a corresponding one of a larger
plurality of coupling positions including the first and second
coupling positions, further wherein an outline of the coupling
positions defines a first shape and an outline of the coupler
portions defines a corresponding second shape at least generally
similar to the first shape.
16. An apparatus for supporting couplers for removable coupling to
a recipient during at least one of therapy administration and
recipient monitoring, the apparatus comprising a support member
configured to rest on a body of the recipient, the support member
having a first coupler portion configured to be positioned
proximate to a first coupling position of the body of the
recipient, the support member further having a second coupler
portion configured to be positioned proximate to a second coupling
position of the body of the recipient, the first coupler portion
being configured to removably carry a first coupler, wherein the
first coupler is movable relative to the first coupler portion
between a first carried position with the first coupler carried by
the first coupler portion and a first coupled position with the
first coupler operatively coupled to the recipient at the first
coupling position the second coupler location being configured to
removably carry a second coupler, wherein the second coupler is
movable relative to the second coupler portion between a second
carried position with the second coupler carried by the second
coupler portion and a second coupled position with the second
coupler operatively coupled to the recipient at the second coupling
position, the first coupler portion configured to be positioned
closer than the second coupler portion to the first coupling
position of the body of the recipient.
17. The apparatus of claim 16, further comprising: a first
engagement member depending from the support member at the first
coupler portion and configured to removably engage the first
coupler; and a second engagement member depending from the support
member at the second coupler portion and configured to removably
engage the second coupler.
18. The apparatus of claim 16, further comprising the first and
second couplers.
19. The apparatus of claim 16, further comprising: the first
coupler, wherein the first coupler has an electrical contact
configured to be connected to a percutaneous electrical probe
inserted into the patient; and a flexible cable connected between
the first coupler and the support member, the cable remaining
connected between the first coupler and the support member when the
first coupler is moved from the first carried position to the first
coupled position.
20. The apparatus of claim 16, further comprising the first coupler
and wherein the first coupler is configured to receive electrical
signals from the recipient when the first coupler is coupled to the
recipient at the first coupling position.
21. The apparatus of claim 16, further comprising the first
coupler, and wherein the first coupler is configured to provide
liquid medicament to the recipient when the first coupler is
coupled to the recipient at the first coupling position.
22. The apparatus of claim 16, further comprising the first coupler
and wherein the first coupler is configured to transmit electrical
signals to the recipient when the first coupler is coupled to the
recipient at the first coupling position.
23. An apparatus for supporting couplers for removable coupling to
a recipient during at least one of therapy administration and
recipient monitoring, the apparatus comprising: a support member
which aids in placement of the couplers on the recipient, and is
configured to rest on a body of the recipient, the support member
having a first coupler portion configured to be positioned
proximate to a first coupling position of the body of the recipient
and a second coupler portion configured to be positioned proximate
to a second coupling position of the body of the recipient, the
first coupler portion being configured to removably carry a first
coupler, the second coupler portion being configured to removably
carry a second coupler, the first coupler portion configured to be
positioned closer than the second coupler portion to the first
coupling position of the body of the recipient; wherein the support
member includes a cavity at the first coupler portion positioned to
receive at least a portion of the first coupler.
24. The apparatus of claim 4 wherein the support member includes a
column at the first coupler portion positioned to be received in an
aperture of the first coupler.
25. The apparatus of claim 16 wherein the support member is shaped
to rest on at least one of a back, a neck, a head and a leg of the
recipient.
26. The apparatus of claim 16 wherein the first and second coupler
portions are two of a larger plurality of coupler portions, wherein
each of the larger plurality of coupler portions are configured to
be positioned proximate to a corresponding one of a larger
plurality of coupling positions including the first and second
coupling positions, further wherein an outline of the coupling
positions defines a first shape and an outline of the coupler
locations defines a corresponding second shape at least generally
similar to the first shape.
27. An apparatus for supporting couplers for removable coupling to
a recipient during at least one therapy administration and
recipient monitoring, the apparatus comprising: a support member
configured to rest on a body of the recipient proximate to a
coupling region, the support member having a first engagement
portion configured to be positioned proximate to a first coupling
position on the body of the recipient and a second engagement
portion configured to be positioned proximate to a second coupling
position on the body of the recipient; a first engagement member
configured to removably carry a first coupler at the first
engagement portion of the support member, wherein the first coupler
is movable relative to the first coupler portion between a first
attached position with the first coupler carried by the first
engagement member and a first coupled position with the first
coupler operatively coupled to the recipient at the first coupling
position; and a second engagement member configured to removably
carry a second coupler at the second engagement portion of the
support member, wherein the second coupler is movable relative to
the second coupler portion between a second attached position with
the second coupler carried by the second engagement member and a
second coupled position with the second coupler operatively coupled
to the recipient at the second coupling position, the first
engagement member configured to be positioned closer than the
second engagement member to the first coupling position.
28. An apparatus for supporting couplers for removable coupling to
a recipient during at least one of therapy administration and
recipient monitoring, the apparatus comprising: a first coupler
having an electrical contact configured to be connected to a
percutaneous electrical probe inserted into the recipient; a
support member which aids in placement of the couplers on the
recipient, and is configured to rest on a body of the recipient
proximate to a coupling region, the support member having a first
engagement portion configured to be positioned proximate to a first
coupling position on the body of the recipient and a second
engagement portion configured to be positioned proximate to a
second coupling position on the body of the recipient; a first
engagement member configured to removably carry the first coupler
at the first engagement portion of the support member; a second
engagement member configured to removably carry a second coupler at
the second engagement portion of the support member, the first
engagement member configured to be positioned closer than the
second engagement member to the first coupling position; and a
flexible cable connected between the first coupler and the support
member, the cable remaining connected between the first coupler and
the support member when the first coupler is moved from a first
attached position with the first coupler carried by the first
engagement member to a first coupled position with the first
coupler operatively coupled to the recipient.
29. An apparatus for supporting couplers for removable coupling to
a recipient monitoring, the apparatus comprising: a support member
configured to rest on a body of the recipient proximate to a
coupling region, the support member having a first engagement
portion configured to a be positioned proximate to a first coupling
position on the body of ht recipient and a second engagement
portion configured to be positioned proximate to a second coupling
position on the body of the recipient; a first engagement member
configured to removably carry a first coupler at the first
engagement portion of the support member; and a second engagement
member configured to removably carry a second coupler at the second
engagement portion of the support member, the first engagement
member configured to be positioned closer than the second
engagement member to the first coupling position wherein the
support member has a central axis, a first elongated portion
positioned along the central axis, a second elongated portion
extending transversely to the central axis on first and second
sides of the central axis, and a third elongated portion positioned
between the first and second elongated portions and extending
transversely to the central axis on the first and second sides of
the central axis, further wherein the first and second engagement
members are positioned on one of the elongated portions, with the
first engagement member including a first post positioned on the
first side of the central axis and the second engagement member
including second a post positioned on the second side of the
central axis.
30. The apparatus of claim 27 wherein the first coupler is
configured to receive electrical signals from the recipient when
the first coupler is coupled to the recipient at the first coupling
position.
31. The apparatus of claim 27 wherein the first coupler is
configured to provide liquid medicament to the recipient when the
first coupler is coupled to the recipient at the first coupling
position.
32. An apparatus for supporting couplers for removable coupling to
a recipient during at least one of therapy administration and
recipient monitoring, the apparatus comprising: a first coupler; a
support member which aids in placement of the couplers on the
recipient, and is configured to rest on a body of the recipient
proximate to a coupling region, the support member having a first
engagement portion configured to be positioned proximate to a first
coupling position on the body of the recipient and a second
engagement portion configured to be positioned proximate to a
second coupling position on the body of the recipient; a first
engagement member configured to removably carry the first coupler
at the first engagement portion of the support member; a second
engagement member configured to removably carry a second coupler at
the second engagement portion of the support member, the first
engagement member configured to be positioned closer than the
second engagement member to the first coupling position; and a
flexible link connected between the first coupler and the support
member, the link remaining connected between the first coupler and
the support member when the first coupler is moved from the first
attached position to the first coupled position.
33. The apparatus of claim 32 wherein the link includes an
electrical cable configured to be coupled to a source of electrical
pulses to transmit percutaneous electrical stimulation pulses to
the first coupler.
34. The apparatus of claim 32 wherein the link includes an
electrical cable configured to be coupled to a signal monitor to
monitor electrical signals received at the first coupler from the
recipient.
35. The apparatus of claim 32 wherein the link includes a length of
tubing configured to be coupled to a source of liquid
medicament.
36. The apparatus of claim 28 wherein the first engagement member
includes a column projecting away from the support member, the
column configured to be received in an aperture of the first
coupler.
37. The apparatus of claim 28 wherein the support member is
flexible and resilient to conform to a surface of the body.
38. The apparatus of claim 28 wherein the support member is shaped
to rest on at least one of a back, a neck, a head and a leg of the
recipient.
39. An apparatus for supporting couplers for removable coupling to
a recipient during at least one of therapy administrations and
recipient monitoring, the apparatus comprising: a support member
which aids in placement of the couplers on the recipient, and is
configured to reset on a body of the recipient proximate to a
coupling region, the support member having a first engagement
portion configured to be positioned proximate to a first coupling
position on the body of the recipient and a second engagement
portion configured to be positioned proximate to a second coupling
position on the body of the recipient; a first engagement member
configured to removably carry a first coupler at the first
engagement portion of the support member; and a second engagement
member configured to removably carry a second coupler at the second
engagement portion of the support member, the first engagement
member configured to be position closer than the second engagement
member to the first coupling position; wherein the first engagement
member has a cavity positioned to receive at least a portion of the
first coupler.
40. The apparatus of claim 28 wherein an arrangement of the first
and second engagement members corresponds at least approximately to
an arrangement of the first and second coupling positions.
41. The apparatus of claim 27 wherein the first and second
engagement members are two of a larger plurality of engagement
members, wherein each of the larger plurality of engagement members
are configured to be positioned proximate to a corresponding one of
a larger plurality of coupling positions including the first and
second coupling positions, further wherein an outline of the
coupling positions defines a first shape and an outline of the
engagement members defines a corresponding second shape at least
generally similar to the first shape.
42. The apparatus of claim 28 wherein the first and second coupling
positions are two of a larger plurality of coupling positions
located on first and second sides of a central axis of the support
member, and wherein the first and second engagement members are two
of a larger plurality of engagement members arranged in two rows on
opposite sides of the central axis.
43. The apparatus of claim 28 wherein the first and second coupling
positions each have a longitudinal location along a body
longitudinal axis and a lateral location transverse to the body
longitudinal axis, and wherein the support member has a central
support member axis generally aligned with the body longitudinal
axis during operation, further wherein the first engagement member
has a longitudinal location and a lateral location relative to the
central support member axis that correspond to the longitudinal and
lateral locations of the first coupling position relative to the
body longitudinal axis, still further wherein the second engagement
member has a longitudinal location and a lateral location relative
to the central support member axis that correspond to the
longitudinal and lateral locations of the second coupling position
relative to the body longitudinal axis.
44. The apparatus of claim 28, further comprising the first and
second couplers.
45. The apparatus of claim 28 wherein at least a portion of the
first engagement member has a first color and at least a portion of
the second engagement member has a second color different than the
first color.
46. The apparatus of claim 28 wherein the first engagement member
has a visual indicator corresponding to the first coupling
position.
47. An apparatus for supporting couplers for removable coupling to
a recipient during at least one of therapy administration and
recipient monitoring, the apparatus comprising: a support member
which aids in placement of the couplers on the recipient, and is
configured to rest on a body of the recipient proximate to a
coupling region, the support member having a first engagement
portion configured to be positioned proximate to a first coupling
position on the body of the recipient and a second engagement
portion configured to be positioned proximate to a second coupling
position on the body of the recipient; a first engagement member
configured to removably carry a first coupler at the first
engagement position of the support member; a second engagement
member configured to removably carry a second coupler at the second
engagement portion of the support member, the first engagement
member configured to be positioned closer than the second
engagement member to the first coupling position; and the first
coupler, wherein the first coupler includes an electrical connector
positioned for making electrical contact with a percutaneous probe
at the first coupling position.
48. The apparatus of claim 28 wherein the support member includes a
flexible, bio-compatible material.
49. An apparatus for supporting couplers for removable coupling to
a recipient during at least one of therapy administration and
recipient monitoring, the apparatus comprising: a support member
which aids in the placement of the couplers on the recipient, and
is configured to rest on a body of the recipient proximate to a
coupling region the support member having a first engagement
portion configured to be positioned proximate to a first coupling
position on the body of the recipient and a second engagement
portion configured be positioned proximate to a second coupling
position on the body of the recipient; a first engagement member
configured to removably carry a first coupler at the first
engagement portion of the support member; and a second engagement
member configured to removably carry a second coupler at the second
engagement portion of the support member, the first engagement
member configured to be positioned closer than the second
engagement member to the first coupling position wherein the
support member includes a generally flat, rigid material.
50. The apparatus of claim 28 wherein the first coupler includes an
electrically conductive clamp, and wherein the first engagement
member is configured to carry the first coupler including the
electrically conductive clamp.
51. The apparatus of claim 28 wherein the first coupler includes an
electrically conductive alligator clip, and wherein the first
engagement member is configured to carry the first coupler
including the electrically conductive alligator clip.
52. (canceled)
53. An apparatus for supporting a plurality of percutaneous probe
couplers in position for removable coupling to a recipient,
comprising: a flexible support member which aids in placement of
the couplers on the recipient, and is configured to rest on a body
of a recipient and conform to a curvature of the body proximate to
a location where the couplers are to be coupled to the body; a
first engagement member depending from the support member and
configured to be positioned proximate to a first coupling position
on the body; a first coupler removably engaged with the first
engagement member; a first electrical cable attached between the
first coupler and the support member; a second engagement member
depending from the support member body and configured to be
positioned proximate to a second coupling position on the body of
the recipient, the first engagement member configured to be
positioned closer than the second engagement member to the first
coupling position, the second engagement member configured to be
positioned closer than the first engagement member to the second
coupling position; a second coupler removably engaged with the
second engagement member; and a second electrical cable attached
between the second coupler and the support member.
54. The apparatus of claim 53 wherein the first electrical cable is
attached to the support member at a first attachment location, and
the second electrical cable is attached to the support member at a
second attachment location, and further wherein the first and
second electrical cables are bundled together within the support
member and exit the support member adjacent to each other at a
third attachment location.
55. (canceled)
56. The apparatus of claim 53 wherein the first coupler includes an
electrically conductive clamp.
57. The apparatus of claim 53 wherein the first coupler includes an
electrically conductive alligator clip.
58. The apparatus of claim 53 wherein the first and second
electrical cables have approximately the same length.
59. The apparatus of claim 53 wherein the first electrical cable
has a first length and the second electrical cable has a second
length different than the first length.
60. (canceled)
61. The apparatus of claim 53 wherein the first coupler has an
aperture and wherein the first engagement member includes a column
projecting away from the support member and positioned to be
received in the aperture of the first coupler.
62. The apparatus of claim 53 wherein the support member is shaped
to rest on at least one of a back, a neck, a head and a leg of the
recipient.
63. The apparatus of claim 53 wherein an arrangement of the first
and second engagement members corresponds at least approximately to
an arrangement of the first and second coupling positions.
64. The apparatus of claim 53 wherein the first and second
engagement members are two of a larger plurality of engagement
members, wherein each of the larger plurality of engagement members
are configured to be positioned proximate to a corresponding one of
a larger plurality of coupling positions including the first and
second coupling positions, further wherein an outline of the
coupling positions defines a first shape and an outline of the
engagement members defines a corresponding second shape at least
generally similar to the first shape.
65. An apparatus for supporting a plurality of percutaneous probe
couplers in position for removable coupling to a recipient,
comprising: a flexible support member which aids in placement of
the couplers on the recipient, and is configured to rest on a body
of a recipient and conform to a curvature of the body proximate to
a coupling location where the couplers are to be coupled to the
body, the support member having a central axis; a first engagement
member depending from the support member and positioned on a first
side of the central axis, the first engagement member configured to
be positioned proximate to a first coupling position on the body of
the recipient, the first coupling position located on the first
side of the central axis; a first coupler removably engaged with
the first engagement member; a first electrical cable attached
between the first coupler and the support member; a second
engagement member depending from the support member and positioned
on a second side of the central axis opposite the first side of the
central axis, the second engagement member configured to be
positioned proximate to a second coupling position on the body of
the recipient, the second coupling position located on the second
side of the central axis; a second coupler removably engaged with
the second engagement member; and a second electrical cable
attached between the second coupler and the support member.
66. The apparatus of claim 65 wherein the first electrical cable is
attached to the support member at a first attachment location, and
the second electrical cable is attached to the support member at a
second attachment location, and further wherein the first and
second electrical cables are bundled together within the support
member and exit the support member adjacent to each other at a
third attachment location.
67. (canceled)
68. The apparatus of claim 65 wherein the first coupler includes an
electrically conductive clamp.
69. The apparatus of claim 65 wherein the first coupler includes an
electrically conductive alligator clip.
70. The apparatus of claim 65 wherein the first and second
electrical cables have approximately the same length.
71. The apparatus of claim 65 wherein the first electrical cable
has a first length and the second electrical cable has a second
length different than the first length.
72. (canceled)
73. The apparatus of claim 65 wherein the first coupler has an
aperture and wherein the first engagement member includes a post
projecting away from the support member and positioned to be
received in the aperture of the first coupler.
74. The apparatus of claim 65 wherein the support member is shaped
to rest on at least one of a back, a neck, a head and a leg of the
recipient.
75. The apparatus of claim 65 wherein an arrangement of the first
and second engagement members corresponds at least approximately to
an arrangement of the first and second coupling positions.
76. The apparatus of claim 65 wherein the first and second
engagement members are two of a larger plurality of engagement
members, wherein each of the larger plurality of engagement members
are configured to be positioned proximate to a corresponding one of
a larger plurality of coupling positions including the first and
second coupling positions, further wherein an outline of the
coupling positions defines a first shape and an outline of the
engagement members defines a corresponding second shape at least
generally similar to the first shape.
77. (canceled)
78. (canceled)
79. (canceled)
80. (canceled)
81. (canceled)
82. (canceled)
83. An apparatus for supporting couplers for removable coupling to
a recipient during at least one of therapy administration and
recipient monitoring, the apparatus comprising: support member
which aids in placement of the couplers on the recipient, and is
configured to rest on a body of the recipient, the support member
having a first coupler portion configured to be positioned
proximate to a first coupling position of the body of the
recipient, the support member further having a second coupler
portion configured to be positioned proximate to a second coupling
position of the body of the recipient, the first coupler portion
configured to be positioned closer than the second coupler portion
to the first coupling position on the body of the recipient; a
first coupler configured to be operatively coupled to the body when
spaced apart from the first coupler portion and configured to be
removably supported at the first coupler portion; a second coupler
configured to be operatively coupled to the body when spaced apart
from the second coupler portion and configured to be removably
supported at the second-coupler portion; a recipient care unit
configured to deliver therapy, monitor a condition of the
recipient, or delivery therapy and monitor a condition of the
recipient; and a first link between the care unit and the first
coupler and a second link between the care unit and the second
coupler.
84. (Canceled).
85. The apparatus of claim 83 wherein the recipient care unit
includes a source of medicament.
86. The apparatus of claim 83 wherein the recipient care unit
includes a monitor of electrical signals.
87. An apparatus for supporting couplers for removable coupling to
a recipient during at least one of therapy administration and
recipient monitoring, the apparatus comprising: a support member
which aids in placement of the couplers on the recipient, and is
configured to rest on a body of the recipient, the support member
having a first coupler portion configured to be positioned
proximate to a first coupling position of the body of the
recipient, the support member further having a second coupler
portion configured to be positioned proximate to a second coupling
position of the body of the recipient, the first coupler portion
configured to be positioned closer than the second coupler portion
to the first coupling position on the body of the recipient; a
first coupler configured to be operatively coupled to the body and
removably supported at the first coupler portion; a second coupler
configured to be operatively coupled to the body and removably
supported at the second coupler portion; a recipient care unit
configured to deliver therapy monitor a condition of the recipient,
or delivery therapy and monitor a condition of the recipient; and a
first link between the care unit and the first coupler and second
link between the care unit and the second coupler; wherein the
first coupler is moveable relative to the support member between an
attached position with the first coupler engaged with the support
member at the first coupler location, a detached position with the
first coupler disengaged from the first coupler location, and a
coupled position with the first coupler operatively coupled to the
recipient at the first coupling position, the first coupler having
an electrical contact for connecting to a percutaneous electrical
probe inserted into the patient, and further wherein the first link
includes a flexible electrical cable.
88. (canceled)
89. The apparatus of claim 83 wherein the first coupler has an
aperture and wherein the support member includes a post at the
first coupler location positioned to be received in the aperture of
the first coupler.
90. The apparatus of claim 83 wherein the support member is
flexible and resilient to conform to a surface of the body.
91. The apparatus of claim 83 wherein the support member is shaped
to rest on at least one of a back, a neck, a head and a leg of the
recipient.
92. The apparatus of claim 83 wherein an arrangement of the first
and second coupler locations corresponds at least approximately to
an arrangement of the first and second coupling positions.
93. The apparatus of claim 83 wherein the first and second coupler
portions are two of a larger plurality of coupler portions, wherein
each of the larger plurality of coupler portions are configured to
be positioned proximate to a corresponding one of a larger
plurality of coupling positions including the first and second
coupling positions, further wherein an outline of the coupling
positions defines a first shape and an outline of the coupler
locations defines a corresponding second shape at least generally
similar to the first shape.
94. A method for coupling therapy and/or monitoring equipment to a
recipient, comprising: positioning a support member against a body
of a recipient proximate to a coupling area of the body and spaced
apart from first and second coupling positions in the coupling
area; supporting a first coupler relative to the body at a first
coupler location of the support member proximate to the first
coupling position; supporting a second coupler relative to the body
at a second coupler location of the support member proximate to the
second coupling position; removing the first coupler from the first
coupler location of the support member and coupling the first
coupler to the body at the first coupling position; and removing
the second coupler from the second coupler location of the support
member and coupling the second coupler to the body at the second
coupling position.
95. The method of claim 94 wherein positioning the support member
includes positioning a first elongated portion of the support
member along a longitudinal axis of the coupling area, positioning
a second elongated portion of the support member transverse to the
longitudinal axis, and positioning a third elongated portion of the
support member transverse to the longitudinal axis between the
first and second elongated portions.
96. The method of claim 94 wherein coupling the first coupler to
the body includes electrically coupling the first coupler to the
body, and wherein the method further includes transmitting
electrical signals to the body.
97. The method of claim 94 wherein supporting the first coupler
includes supporting the first coupler closer than the second
coupler to the first coupling position.
98. The method of claim 94, further comprising conforming the
support member to a curved surface of the body.
99. The method of claim 94 wherein positioning the support member
against the body includes positioning the support member against at
least one of a back, a neck, a head and a leg of the recipient.
100. The method of claim 94 wherein the first and second coupling
positions are two of a larger plurality of coupling positions and
the first and second coupler locations are two of a larger
plurality of coupler locations and wherein the method further
comprises orienting the support member with an outline of the
coupler locations being generally similar to an outline defined by
the coupling positions.
101. The method of claim 94 wherein coupling the first coupler
includes coupling the first coupler to a percutaneous probe at the
first coupling position.
102. A method for coupling therapy and/or monitoring equipment to a
recipient, comprising: positioning a support member against a body
of a recipient proximate to a coupling area of the body, the
support member being elongated along a support member axis;
supporting a first coupler relative to the body at a first coupler
location of the support member proximate to a first coupling
position of the body; supporting a second coupler relative to the
body at a second coupler location of the support member proximate
to a second coupling position of the body with the first coupler
positioned closer than the second coupler to the support member
axis; removing the first coupler from the first coupler location of
the support member and coupling the first coupler to the body at
the first coupling position; and removing the second coupler from
the second coupler location of the support member and coupling the
second coupler to the body at the second coupling position.
103. The method of claim 102 wherein positioning the support member
includes positioning a first elongated portion of the support
member along a longitudinal axis of the coupling area, positioning
a second elongated portion of the support member transverse to the
longitudinal axis, and positioning a third elongated portion of the
support member transverse to the longitudinal axis between the
first and second elongated portions.
104. The method of claim 102 wherein coupling the first coupler to
the body includes electrically coupling the first coupler to the
body, and wherein the method further includes transmitting
electrical signals to the body.
105. The method of claim 102 wherein supporting the first coupler
includes supporting the first coupler closer than the second
coupler to the first coupling position.
106. The method of claim 102, further comprising conforming the
support member to a curved surface of the body.
107. The method of claim 102 wherein positioning the support member
against the body includes positioning the support member against at
least one of a back, a neck, a head and a leg of the recipient.
108. The method of claim 102 wherein the first and second coupling
positions are two of a larger plurality of coupling positions and
the first and second coupler locations are two of a larger
plurality of coupler locations and wherein the method further
comprises orienting the support member with an outline of the
coupler locations being generally similar to an outline defined by
the coupling positions.
109. The method of claim 102 wherein coupling the first coupler
includes coupling the first coupler to a percutaneous probe at the
first coupling position.
110. A method for coupling therapy and/or monitoring equipment to a
recipient, comprising: positioning a support member against a body
of a recipient proximate to a coupling area; supporting a first
coupler relative to the body at a first coupler location of the
support member proximate to a first coupling position on the body;
supporting a second coupler relative to the body at a second
coupler location of the support member proximate to a second
coupling position on the body, the first coupler location being
positioned closer than the second coupler location to the first
coupling position; removing the first coupler from the first
coupler location of the support member and coupling the first
coupler to the body at the first coupling position; and removing
the second coupler from the second coupler location of the support
member and coupling the second coupler to the body at the second
coupling position.
111. The method of claim 110 wherein positioning the support member
includes positioning a first elongated portion of the support
member along a longitudinal axis of the coupling area, positioning
a second elongated portion of the support member transverse to the
longitudinal axis, and positioning a third elongated portion of the
support member transverse to the longitudinal axis between the
first and second elongated portions.
112. The method of claim 110 wherein coupling the first coupler to
the body includes electrically coupling the first coupler to the
body, and wherein the method further includes transmitting
electrical signals to the body.
113. The method of claim 110 wherein coupling the first coupler to
the body includes electrically coupling the first coupler to the
body, and wherein the method further includes receiving electrical
signals from the body.
114. The method of claim 110 wherein the first coupler is
configured to provide liquid medicament to the recipient and
wherein the method further comprises delivering liquid medicament
to the first coupler and the recipient when the first coupler is
coupled to the recipient at the first coupling position.
115. The method of claim 110 wherein removing the first coupler
includes removing the first coupler from an aperture of the support
member.
116. The method of claim 110 wherein removing the first coupler
includes removing the first coupler from a post of the support
member.
117. The method of claim 110, further comprising conforming the
support member to a curved surface of the body.
118. The method of claim 110 wherein positioning the support member
against the body includes positioning the support member against at
least one of a back, a neck, a head and a leg of the recipient.
119. The method of claim 110 wherein positioning the support member
includes orienting the support member with an arrangement of the
first and second coupler locations corresponding at least
approximately to an arrangement of the first and second coupling
positions.
120. The method of claim 110 wherein the first and second coupling
positions are two of a larger plurality of coupling positions and
the first and second coupler locations are two of a larger
plurality of coupler locations and wherein the method further
comprises orienting the support member with an outline of the
coupler locations being generally similar to an outline defined by
the coupling positions.
121. The method of claim 110 wherein coupling the first coupler
includes coupling the first coupler to a percutaneous probe at the
first coupling position.
122. The method of claim 110 wherein coupling the first coupler
includes clamping the first coupler to a percutaneous electrode
inserted in the recipient.
123. A method for administering percutaneous electrical therapy to
a recipient, comprising: aligning a flexible support member with a
body of a recipient; positioning the support member against the
body proximate to a coupling area; conforming the support member to
a curvature of the body supporting a first coupler relative to the
body at a first coupler location of the support member proximate to
a first coupling position of the body; supporting a second coupler
relative to the body at a second coupler location of the support
member proximate to a second coupling position of the body with the
first coupler location positioned closer than the second coupler
location to the first coupling position; removing the first coupler
from the first coupler location of the support member and
electrically coupling the first coupler to a first percutaneous
probe positioned in the body at the first coupling position;
removing the second coupler from the second coupler location of the
support member and electrically coupling the second coupler to a
second percutaneous probe in the body at the second coupling
position; and electrically coupling the first and second couplers
to a source of electrical potential.
124. The method of claim 123, further comprising actuating the
first coupler to insert the first percutaneous probe in the
recipient.
125. The apparatus of claim 123 wherein the support member has a
central axis, a first elongated portion positioned along the
central axis, a second elongated portion extending transversely to
the central axis on first and second sides of the central axis, and
a third elongated portion positioned between the first and second
elongated portions and extending transversely to the central axis
on the first and second sides of the central axis, further wherein
the first and second coupler locations are positioned on one of the
elongated portions, with the support member including a post
positioned at the first coupler location on the first side of the
central axis and the support member further including a post
positioned at the second coupler location on the second side of the
central axis.
126. The method of claim 123 wherein the first coupler has an
aperture and wherein removing the first coupler includes
disengaging the aperture with a post of the support member.
127. The method of claim 123, further comprising resting the
support member on at least one of a back, a neck, a head and a leg
of the recipient.
128. The method of claim 123, further comprising orienting the
support member with an arrangement of the first and second coupler
locations corresponding at least approximately to an arrangement of
the first and second coupling positions.
129. A method for administering percutaneous electrical therapy to
a recipient, comprising: aligning a flexible support member with a
body of a recipient by aligning a first elongated portion of the
support member with a spine of the recipient and positioning second
and third elongated portions of the support member transverse to
the spine; conforming the support member to the body proximate to a
coupling area; removing five pairs of electrical couplers from the
support member and connecting the electrical couplers to
percutaneous probes inserted into the recipient while the
electrical couplers remain connected to the support member with
electrical cables, wherein removing the five pairs of electrical
couplers includes removing couplers of a first pair positioned
toward an end of the first elongated portion, removing couplers of
a second pair positioned at opposite ends of the second elongated
portion, removing couplers of a third pair positioned at opposite
ends of the third elongated portion, removing couplers of a fourth
pair positioned between the first and second pair, and removing
couplers of a fifth pair positioned between the second and third
pair; and electrically connecting each coupler to an electrically
conductive percutaneous probe inserted in the body.
130. The method of claim 129, further comprising electrically
coupling each coupler to a source of electrical potential.
131. The apparatus of claim 4 wherein the support member is
elongated along a support member axis.
132. The apparatus of claim 4, further comprising: a first
engagement member depending from the support member at the first
coupler portion and configured to removably engage the first
coupler; and a second engagement member depending from the support
member at the second coupler portion and configured to removably
engage the second coupler.
133. The apparatus of claim 4, further comprising the second
coupler.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation-in-part of: (1) U.S.
application Ser. No. 09/452,477, titled "Percutaneous Electrical
Therapy System with Electrode Entry Angle Control," filed Dec. 1,
1999; and (2) U.S. application Ser. No. 09/666,931, titled "Method
and Apparatus for Repositioning a Percutaneous Probe," filed Sep.
21, 2000, both incorporated herein in their entireties by
reference.
TECHNICAL FIELD
[0002] This invention relates generally to apparatuses and methods
for coupling therapeutic and/or monitoring equipment to a
patient.
BACKGROUND
[0003] Electrical therapy has long been used in medicine to treat
pain and other conditions. For example, transcutaneous electrical
nerve stimulation (TENS) systems deliver electrical energy through
electrode patches placed on the surface of a patient's skin to
treat pain in tissue beneath and around the location of the
patches. However, the TENS systems may not adequately alleviate
pain in certain circumstances.
[0004] More, recently, a technique in which electrodes are placed
through the patient's skin into the target tissue has been
proposed. Percutaneous Neuromodulation Therapy ("PNT") (also
sometimes called Percutaneous Electrical Nerve Stimulation or
"PENS") using percutaneously placed electrodes achieves
significantly better pain relief results than TENS treatments using
skin surface electrodes. This therapy is described in Ghoname et
al., "Percutaneous Electrical Nerve Stimulation for Low Back Pain,"
JAMA 281:818-23 (1999); Ghoname et al., "The Effect of Stimulus
Frequency on the Analgesic Response to Percutaneous Electrical
Nerve Stimulation in Patients with Chronic Low Back Pain," Anesth.
Analg. 88:841-6 (1999); Ahmed et al., "Percutaneous Electrical
Nerve Stimulation (PENS): A Complementary Therapy for the
Management of Pain Secondary to Bony Metastasis," Clinical Journal
of Pain 14:320-3 (1998); and Ahmed et al., "Percutaneous Electrical
Nerve Stimulation: An Alternative to Antiviral Drugs for Herpes
Zoster," Anesth. Analg. 87:911-4 (1998). The contents of these
references are incorporated herein by reference.
[0005] Thus far, PNT practitioners have used percutaneously placed
acupuncture needles attached to waveform generators via cables and
alligator clips to deliver the therapy to the patient. One feature
of conventional PNT systems is that they typically include a number
of electrical cables that must be properly connected to the
corresponding percutaneous electrodes to deliver effective
electrical therapy. Accordingly, a drawback with these conventional
systems is that it can be difficult (particularly for inexperienced
practitioners) to connect each electrical cable to the proper
corresponding electrode. This drawback is shared as well by other
systems that require multiple connections to the patient. Such
systems include electrical monitoring systems and drug delivery
systems.
SUMMARY
[0006] The invention is directed to apparatuses and methods for
supporting therapeutic and/or diagnostic couplers for removable
coupling to a recipient. An apparatus in accordance with one aspect
of the invention can include a support member configured to rest on
a body of the recipient proximate to a coupling region. The support
member can include a first coupler location configured to removably
carry a first coupler proximate to a first coupling position of the
body of the recipient. The support member can further include a
second coupler location configured to removably carry a second
coupler proximate to a second coupling position of the body of the
recipient. In one aspect of the invention, the support member can
be spaced apart from the first and second coupling positions. In
another aspect of the invention, the support member can be
elongated along a support member axis and the first coupler
location can be positioned closer than the second coupler location
to the support member axis. In still another aspect of the
invention, the first coupler location can be positioned closer than
the second coupler location to the first coupling position.
Accordingly, the apparatus can guide a practitioner to connect the
couplers to the correct coupling position.
[0007] In another aspect of the invention, the support member can
be flexible and resilient to conform to a surface of the body, and
can be shaped to rest on at least one of a back, a neck, a head,
and a leg of the recipient. The apparatus can further include a
flexible link coupled between the first coupler and the support
member. The link can remain connected between the first coupler and
the support member when the first coupler is moved from an attached
position to a detached position and then to a coupled position with
the coupler coupled to the body of the recipient. The link can
include an electrical cable configured to be coupled to a source of
electrical pulses, an electrical cable configured to be coupled to
a signal monitor, and/or a length of tubing configured to be
coupled to a source of liquid medicament.
[0008] In yet another aspect of the invention, the first and second
coupling positions can be two of a larger plurality of coupling
positions and the first and second coupler locations can be two of
a larger plurality of coupler locations. An outline of the coupling
positions can define a first shape and an outline of the coupler
locations can define a corresponding second shape at least
generally similar to the first shape.
[0009] The invention is also directed toward a method for coupling
therapy and/or monitoring equipment to a recipient. The method can
include positioning a support member against a body of a recipient
proximate to a coupling area, supporting a first coupler relative
to the body at a first coupler location of the support member
proximate to a first coupling position of the body, and supporting
a second coupler relative to the body at a second coupler location
of the support member proximate to a second coupling position of
the body. In one aspect of the invention, the support member can be
elongated along a support member axis and the first coupler
location can be positioned closer than the second coupler location
to the first coupling position and/or to the support member axis.
In another aspect of the invention, the support member can be
spaced apart from the first and second coupling positions. The
method can further include removing the first coupler from the
support member and coupling the first coupler to the body at the
first coupling position, and removing the second coupler from the
support member and coupling the second coupler to the body at the
second coupling position.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] FIG. 1A-G are schematic renderings of a percutaneous
electrical therapy system according to one embodiment of this
invention.
[0011] FIG. 1A shows electrode and angle of insertion assemblies
wherein the electrode is in an undeployed and uninserted state.
[0012] FIG. 1B shows the electrode and angle of insertion
assemblies of FIG. 1A during deployment but prior to insertion of
the electrode into a patient's tissue.
[0013] FIG. 1C shows the electrode and angle of insertion
assemblies of FIG. 1A during deployment and insertion of the
electrode into the patient's tissue.
[0014] FIG. 1D shows the electrode of FIG. 1A inserted into the
patient's tissue.
[0015] FIG. 1E shows the electrode of FIG. 1A attached to a control
unit to provide percutaneous electrical therapy.
[0016] FIG. 1F shows the electrode and angle of insertion
assemblies of FIG. 1A during undeployment but prior to removing the
electrode from the patient's tissue.
[0017] FIG. 1G shows the electrode and sharp point protection
assemblies of FIG. 1A during undeployment and after removing the
electrode from the patient's tissue.
[0018] FIGS. 2A-E are schematic renderings of a percutaneous
electrical therapy system according to another embodiment of this
invention.
[0019] FIG. 2A shows a percutaneous electrical therapy system with
electrode and angle of insertion assemblies wherein the electrode
is in an undeployed and uninserted state.
[0020] FIG. 2B shows the percutaneous electrical therapy system of
FIG. 2A during deployment, but prior to insertion, of the
electrode.
[0021] FIG. 2C shows the percutaneous electrical therapy system of
FIG. 2A with the electrode in a deployed and inserted state.
[0022] FIG. 2D shows the percutaneous electrical therapy system of
FIG. 2A during undeployment of the electrode.
[0023] FIG. 2E shows the percutaneous electrical therapy system of
FIG. 2A after the electrode has been undeployed.
[0024] FIG. 3 shows an electrode montage for use in percutaneous
neuromodulation therapy to treat low back pain. FIG. 4 is an
exploded sectional view of an electrode and angle of insertion
assembly according to yet another embodiment of this invention.
[0025] FIG. 5 is a partially exploded elevational view of the
embodiment of FIG. 4.
[0026] FIG. 6 is an elevational view of the embodiment of FIG. 4
showing the electrode and angle of insertion assemblies and a
coupler.
[0027] FIG. 7 is a sectional view of the embodiment of FIG. 4
showing the electrode and angle of insertion assemblies and a
coupler.
[0028] FIG. 8 is a sectional view of the embodiment of FIG. 4
showing the coupler in engagement with the electrode and angle of
insertion assemblies prior to insertion of the electrode into a
patient's tissue.
[0029] FIG. 9 is a sectional view of the embodiment of FIG. 4 with
the electrode in its deployed and inserted state.
[0030] FIG. 10 shows a montage for using the embodiment of FIG. 4
to treat low back pain with the electrodes in a partially deployed
but uninserted state.
[0031] FIG. 11 shows the electrode montage of FIG. 10 at the
beginning of the electrode insertion step.
[0032] FIG. 12 shows the electrode montage of FIG. 10 with the
electrodes deployed, inserted and attached to a control unit to
provide electrical therapy to the patient.
[0033] FIG. 13 is an exploded view of an electrode introducer and
angle of insertion assembly of yet another embodiment of this
invention.
[0034] FIG. 14 is a partial sectional view of the introducer and
angle of insertion assembly of FIG. 13.
[0035] FIG. 15 is a sectional view of the introducer and angle of
insertion assembly of FIG. 13.
[0036] FIG. 16 is an elevational view of gear assemblies of the
introducer and angle of insertion assembly of FIG. 13.
[0037] FIG. 17 shows part of the electrode assembly of the
embodiment of FIGS. 13-16 in a montage used for treating low back
pain using PNT.
[0038] FIG. 18 is an elevational view showing the introducer of
FIG. 13 in the process of deploying an electrode.
[0039] FIG. 19 is a sectional view showing the introducer of FIG.
13 in the process of deploying an electrode, prior to insertion of
the electrode.
[0040] FIG. 20 is a sectional view showing the introducer of FIG.
13 in the process of deploying an electrode, during insertion of
the electrode.
[0041] FIG. 21 is a sectional view showing the introducer of FIG.
13 in the process of deploying an electrode, also during insertion
of the electrode.
[0042] FIG. 22 is a sectional view of an inserted electrode
assembly of the embodiment of FIGS. 13-16.
[0043] FIG. 23 is a partially schematic, top isometric view of a
coupler support in accordance with an embodiment of the
invention.
[0044] FIG. 24 is a partially schematic, top isometric view of a
coupler support positioned on the back of a recipient in accordance
with another embodiment of the invention.
[0045] FIG. 25 is a partially schematic, top plan view of a support
member positioned near coupling positions in accordance with
another embodiment of the invention.
[0046] FIG. 26 is a top isometric view of a portion of a coupler
support configured to support a coupler in accordance with another
embodiment of the invention.
[0047] FIG. 27 is a top isometric view of a portion of a coupler
support having an aperture configured to receive a clamp-type
coupler in accordance with still another embodiment of the
invention.
[0048] FIG. 28 is a top isometric view of a portion of a coupler
support having a post configured to be clamped by a clamp-type
coupler in accordance with yet another embodiment of the
invention.
[0049] FIG. 29 is a partially schematic illustration of an
arrangement that includes a coupler support configured to support
couplers for receiving diagnostic information in accordance with
yet another embodiment of the invention.
[0050] FIG. 30 is a partially schematic illustration of an
arrangement that includes a coupler support configured to support a
plurality of couplers that administer liquid medicament in
accordance with still another embodiment of the invention.
DETAILED DESCRIPTION
[0051] Percutaneous electrical therapy systems, such as PNT
systems, deliver electric current to a region of a patient's tissue
through electrodes that pierce the skin covering the tissue. The
electric current is generated by a control unit external to the
patient and typically has particular waveform characteristics such
as frequency, amplitude and pulse width. Depending on the treatment
or therapy being delivered, there may be one electrode containing
both a cathode and an anode or a plurality of electrodes with at
least one serving as a cathode and at least one serving as an
anode.
[0052] The electrode has a sharp point not only to facilitate
insertion through the patient's skin but also to enhance local
current density during treatment. The placement and location of the
electrode point is therefore an important aspect of the therapy.
The electrodes must also be properly coupled to the control unit to
form a complete circuit for delivering therapeutic electric current
to the patient.
[0053] FIGS. 1A-G are block diagrams showing deployment and use of
a percutaneous electrical therapy system and electrode assembly in
accordance with an embodiment of the invention. As shown in FIGS.
1A and 1B, the system can include an electrode 1 having a sharp
point 2 at its distal end and a housing 4 surrounding at least the
sharp point 2 when the electrode is in its undeployed and
uninserted states. The undeployed and uninserted states include
pre-deployment and post-deployment states of the electrode 1. The
housing 4 can have an aperture 5 at its distal end. An actuator 6
can interact with a handle 11 at the proximal end of electrode 2 as
shown to move the electrode 1.
[0054] Deployment of the electrode assembly can include the steps
taken to place the electrode assembly in proper position and
condition for use in electrical therapy. FIG. 1A shows the
electrode assembly in an undeployed (pre-deployed) state. During
deployment, the distal face 7 of housing 4 is placed against a
patient's skin 22, as shown in FIG. 1B. This action supports
housing 4 with respect to the patient's skin, thereby controlling
the angle between the housing and the patient's skin. Electrode 2
is then inserted through aperture 5 into the tissue underlying the
patient's skin by moving actuator 6 distally, as shown in FIG. 1C.
As it moves, actuator 6 (and therefore electrode 2) is supported by
housing 4 to control the angle at which the electrode 1 enters into
the patient's tissue.
[0055] The actuator 6 may have a limit stop 9 element cooperating
with a limit stop area 8 of the housing 4 to limit distal motion of
the actuator 6 and to control the depth of insertion of the sharp
point 2 of the electrode 1. In one embodiment, for example, when
the electrical therapy system is used to provide percutaneous
neuromodulation therapy, the predetermined electrode depth is 3 cm.
Other electrode depths may be used, of course, depending on the
intended application and therapy.
[0056] After insertion, the housing 4 and the actuator 6 (which
have heretofore acted as an electrode introducer) can be removed,
as shown in FIG. 1D. The electrode 1 can be connected to a control
unit 10 via a conductor or cable 16. For use with PNT, the control
unit 10 can supply a current-regulated and current-balanced
waveform with an amplitude of up to approximately 20 mA, a
frequency between approximately 4 Hz and 50 Hz, and pulse width of
between approximately 50 .mu.sec and 1 msec. Other electrical
waveforms having other parameters may be used, of course, depending
on the therapy to be provided. Also, while FIG. 1E shows only one
electrode connected to the control unit, it should be understood
that a plurality of electrodes may be connected to a single control
unit.
[0057] After completion of the electrical therapy, the electrode
assembly can be undeployed. In an embodiment shown in FIG. 1F, the
aperture 5 of housing 4 is placed over the handle portion 11 of
electrode 1. Housing 4 may be the same housing used to deploy and
insert the electrode (i.e., the electrode introducer), or it may be
an entirely different assembly (e.g., an electrode remover). The
sharp point 2 of electrode 1 is then drawn into housing 4 of sharp
point protection assembly 3 by moving actuator 6 proximally, as
shown in FIG. 1G.
[0058] FIGS. 2A-E are block diagrams showing another embodiment of
the invention. In one aspect of this embodiment, a control unit 10
is connected to an electrode 12 within an electrode assembly 13 via
a conductor 16. As above, for use with PNT, the control unit 10 can
supply a current-regulated and current-balanced waveform with an
amplitude of up to approximately 20 mA, a frequency between
approximately 4 Hz and 50 Hz, and pulse width of between
approximately 50 .mu.sec and 1 msec. In other embodiments, the
control unit 10 can supply electrical current having other
characteristics. As shown in its undeployed state in FIG. 2A and in
its uninserted stated in FIG. 2B, the system can include a housing
18 surrounding the sharp point 20 of electrode 12 when the
electrode point 20 has not yet been inserted through the patient's
skin 22.
[0059] To begin deployment, a distal face 21 of the housing 18 is
placed against the patient's skin 22, as shown in FIG. 2B. As with
the previous embodiment, this action supports the housing 18 with
respect to the patient's skin, thereby controlling the angle
between the housing and the patient's skin. The sharp point 20 of
electrode 12 is then inserted through an aperture 24 into the
tissue underlying the patient's skin by moving an actuator 19
distally, as shown in FIG. 2C. As it moves, the actuator 19 (and
therefore the electrode 12) is supported by the housing 18 to
control the angle at which the electrode enters into the patient's
tissue.
[0060] The actuator 19 may be part of the electrode assembly 13 or
a separate component of the system. The actuator 19 may also have a
limit stop element 23 that cooperates with a limit stop area 17 of
housing 18 to limit distal movement of actuator 19, thereby
controlling the depth of insertion of electrode 12. In one
embodiment, for example, when the electrical stimulation system is
used to provide percutaneous neuromodulation therapy, the
predetermined electrode depth is approximately 3 cm, although other
electrode depths may be used depending on the application. The
control unit 10 may then provide the appropriate therapy to the
patient through the electrode 12 and any other electrodes connected
to it.
[0061] During undeployment, the actuator 19 can draw the electrode
12 back proximally into the housing 18. After the electrode 12 is
removed from the patient's skin, the housing 18 of sharp point
protection assembly 14 once again surrounds the sharp point 20 of
the now uninserted electrode 12, as shown in FIGS. 2D and 2E. The
actuator 19 helps enable this operation to occur without ever
exposing the sharp point 20 of the electrode 12 when the sharp
point 20 is no longer in the patient. In fact, the operator of the
electrode assembly never sees the sharp point 20 of the electrode
12. Thus, sharp point protection assembly 14 shields the
potentially contaminated portion of the undeployed electrode 12 and
protects the patient's caregiver or other bystander from unintended
contact with the sharp point 20 of the electrode 12 before, during
and after electrical therapy.
[0062] While FIGS. 2A-E show the electrode connected to the control
unit prior to deployment and insertion of the electrode into the
patient's skin, the connection between the control unit and the
electrode could be made during deployment or after insertion. Also,
while FIGS. 2A-E show only one electrode connected to the control
unit, it should be understood that a plurality of electrodes may be
connected to a single control unit, as called for by the desired
electrical stimulation treatment.
[0063] To use the percutaneous electrical therapy systems of FIGS.
1A-G and FIGS. 2A-E to treat a patient, one or more electrodes are
inserted through the patient's skin into the underlying tissue. As
an example, to treat low back pain using PNT with unipolar
electrodes, an array or montage such as that shown in FIG. 3 may be
used. The "T12"-"S1" designations refer to the patient's vertebrae.
The control unit or generator supplies current pulses between pairs
of electrodes for durations of a few minutes to several hours,
preferably delivering the current-regulated waveform described
above. Thirty-minute treatments are recommended in the Ghoname et
al. low back pain treatment articles.
[0064] FIGS. 4-12 show a system in accordance with another
embodiment of this invention. An electrode assembly 30 can include
a base 32, an electrode 34, and a plunger or actuator 36. The base
32 can have a flange or flared end 44 that is adapted to make
contact with a patient's skin. The base 32 may be formed from any
suitable polymer or metal, such as a high-density polyethylene
(HDPE). The base 32 can be opaque so that the electrode 34 cannot
be seen by a needle-shy patient.
[0065] The actuator 36 fits within a housing portion 40 of base 32
in a slidable arrangement. A locking assembly can prevent relative
movement between the actuator 36 and the housing 40 of the base 32.
In one embodiment, the locking assembly of the actuator 36 has
integrally-formed resilient detents 48 on its exterior cylindrical
surface. In the undeployed state of electrode assembly 30, the
detents 48 mate with corresponding openings 50 in the base 32 to
hold the actuator 36 and the base 32 in place with respect to each
other to prevent the electrode 34 from moving outside of the
protective housing 40 of the base 32, thereby providing sharp point
protection. In other embodiments, mechanisms other than the detent
and opening arrangement may be used to hold the actuator and base
in place.
[0066] In one embodiment, the electrode 34 can include a 3-cm long
32-gauge stainless steel needle. Other sizes and materials may be
used for the electrode 34, of course, without departing from the
scope of the invention. The actuator 36 can be formed from HDPE as
well, although other suitable materials may be used.
[0067] The electrode 34 can have a larger-diameter handle 52 at its
proximal end. The handle 52 can fit within a channel 54 formed
within the actuator 36. The channel 54 can have a narrow opening 56
at its distal end, with a diameter slightly larger than the
diameter of electrode 34 but narrower than the diameter of handle
52 to hold electrode 34 in place within the actuator 36 after
initial manufacture and assembly. In the undeployed state shown in
FIG. 7, the sharp point 38 of electrode 34 is disposed within
housing portion 40 of base 32, specifically, within a narrow
channel 42 of the housing 40.
[0068] To deploy one or more electrode assemblies on a patient in
order to provide electrical stimulation therapy (such as PNT), the
distal surface 46 of the flange portion 44 of the base 32 can be
mounted on the desired site on the patient's skin, preferably with
a compressible adhesive pad (not shown) surrounding a ring 43
extending downward from surface 46 around an aperture 41 formed at
the distal end of channel 42, although other means of attaching
base 32 to the patient may be used as appropriate. This action
aligns the base 32 with respect to the patient's skin. The flange
portion 44 of the base 32 provides extra stability for the
electrode assembly during electrode insertion and use.
[0069] A coupler or actuator tool 60 can be used to both insert the
electrode and connect the electrode electrically with a control
unit 62. The coupler 60 and the electrode assembly 30 can also
interact to provide the sharp point protection assembly of this
embodiment. When the distal end of the coupler 60 is placed against
the proximal ends of the base 32 and the actuator 36, the exposed
proximal end 64 of the electrode handle 52 makes electrical contact
with a contact surface 66 within the coupler 60. The contact
surface 66, in turn, can be electrically connected to the control
unit 62 via a cable or other conductor 68.
[0070] The coupler 60 can have two oppositely disposed pegs 70
extending outwardly from the distal portion of its cylindrically
surface. The pegs 70 can mate with two corresponding slots 72 in
the actuator 36 and with two corresponding grooves 74 in the base
32. The second of the two slots 72 and the second of the two
grooves 74 are each opposite the slot 72 and groove 74,
respectively, shown in FIGS. 4 and 5. When connecting the coupler
60 to the electrode assembly 30, the pegs 70 move along
longitudinal portions 76 of the slots 72 and along longitudinal
portions 78 of the grooves 74. Concurrently, the exposed distal end
64 of the electrode handle 52 begins to make sliding contact with
the contact surface 66 of actuator tool 60 to create the electrical
connection between coupler 60 and the electrode 32.
[0071] The coupler 60 can be rotated clockwise (looking down on the
assembly), after the pegs 70 reach the end of the longitudinal
portions 76 and 78. Accordingly, the pegs 70 move into short
circumferential portions 80 and 82, respectively, of the slots 72
and the grooves 74. The length of the circumferential portions 80
of the slots 72 is less than the length of the circumferential
portions 82 of the grooves 74. Continued movement of the pegs 70
along the circumferential portions 82 will therefore move the pegs
70 against the ends 81 of the circumferential slots 80. Further
clockwise rotation of the coupler 60 will cause the actuator 36 to
rotate clockwise as well, thereby moving the detents 48 out of the
openings 50 and allowing the electrode 34 and the actuator 36 to
move with respect to base 32.
[0072] Second longitudinal portions 84 of the grooves 74 can be
formed in base 32 at the end of circumferential portions 82.
Movement of the pegs 70 distally along the second longitudinal
portions 84 pushes the pegs 70 against the distal edges of the
circumferential slot portions 80, thereby moving the actuator 36
and the electrode 34 in a controlled fashion distally toward the
patient's skin 22.
[0073] As it moves, the electrode 34 passes through the channel 42,
and the sharp point of electrode 34 moves out through aperture 41.
The channel 42 and the actuator 36 provide axial support to the
electrode 34 during this forward movement and also, along with the
support provided by the flange 44, provide entry angle guidance to
the electrode 34. In addition, downward pressure on the patient's
skin during electrode deployment can compress the compressible
adhesive pad and press the ring 43 against the patient's skin 22,
which helps ease electrode entry through the skin and also lessens
the insertion pain experienced by the patient.
[0074] The alignment of the base 32 with respect to the patient's
skin and the controlled movement of the actuator 36 and the
electrode 34 within the base 32 can control the angle at which the
electrode enters the tissue underlying the patient's skin. Distal
movement of the electrode 34 and its actuator within the base 32
can continue until a distal surface 86 of a cylindrical cap portion
92 of the coupler 60 meets an annular surface 88 of housing 40. At
this point, the sharp point 38 of the electrode 34 has extended a
predetermined depth into the tissue underlying the patient's skin.
In one embodiment, this predetermined depth is approximately 3 cm,
and the depth can have other values depending on the treatment to
be performed.
[0075] The electrode assembly 30 can also include a deployed
electrode holding mechanism. In one aspect of this embodiment, an
interference fit between the inner surface of channel 42 and the
outer surface 55 of channel 52 performs this function.
[0076] Electrical stimulation treatment may begin once the
electrodes have been deployed and inserted. The control unit 62 can
supply stimulation current to the electrodes, e.g., in the manner
described in the Ghoname et al. articles. The electrical waveform
provided by the control unit depends on the application. For
example, in one embodiment, the control unit 62 can provide a
current-regulated and current-balanced waveform with an amplitude
of up to approximately 20 mA, frequency between approximately 4 Hz
and 50 Hz, and pulse width of between approximately 50 .mu.sec and
1 msec. In other embodiments, the control unit 62 can provide
electrical current at other frequencies.
[0077] The interaction of the coupler 60 and the base 32 can
provide stability to the electrode 34 and its electrical connection
to the control unit during treatment by holding the electrode in
place, by providing strain relief for tugging forces on the cable
68, and by providing a robust mechanical connection. It should also
be noted that in one aspect of these embodiments, the sharp point
of the electrode 34 is not exposed to the operator or to any other
bystander at any point during deployment and use of the electrode
assembly.
[0078] After treatment has been completed, the electrode may be
removed from the patient. To do so, the coupler 60 can be moved
proximally away from the patient. As the pegs 70 move proximally
along the longitudinal portions 84 of the grooves 74, the pegs 70
push against the proximal edges of the actuator's circumferential
slot portions 80, thereby moving the actuator 36 and the electrode
34 proximally as well. When the pegs 70 reach the proximal end of
the longitudinal groove portions 84, the sharp end 38 of the
electrode 34 is out of the patient and safely inside the housing 40
of the base 32. Counterclockwise movement of the coupler 60 moves
the pegs 70 along the circumferential portions 80 and 82 of the
slot 72 and the groove 74, respectively. Because the
circumferential portion 80 is shorter than the circumferential
portion 82, this counterclockwise movement will turn the actuator
36 counterclockwise.
[0079] At the limit of the counterclockwise movement, the detents
48 move back into the openings 50 to prevent further movement of
the electrode and the actuator with respect to the base 32. Further
distal movement of the coupler 60 moves the pegs 70 distally along
the longitudinal portions 76 and 78 of the slot 72 and the groove
74, respectively, to disconnect the coupler 60 from the electrode
assembly 30. The base 32 can then be removed from the patient.
[0080] FIGS. 10-12 show the use of the electrode and sharp point
protection assemblies of FIGS. 4-9 to treat low back pain using
PNT. As shown in FIG. 10, ten electrode assemblies 30a-j are
arranged in a montage on the patient's back and attached with
adhesive. Next, ten couplers 60a-j are attached to the ten
electrode assemblies 30a-j. In one embodiment (shown in FIG. 11),
the couplers 60a-j are supported or carried prior to deployment by
a coupler support 61 (FIG. 12). In one aspect of this embodiment,
the coupler support 61 can include a generally flat, rigid support
member 63 having ten engagement members 65 positioned at
corresponding coupler locations of the support member 63. Each
engagement member 65 can be configured to removably support or
carry one of the couplers 60. For example, each engagement member
65 can include a post projecting upwardly from the support member
63 to be removably received in a corresponding axial aperture of
the coupler 60. As shown in FIG. 12, each coupler 60 can be
connected to the support member 63 with an individual cable 68a-j.
The individual cables 68a-j can be bundled together to form a link
69 (such as a multi-wire cable) that provides electrical
communication between the couplers 60 and a control unit 62.
[0081] In another aspect of this embodiment, an arrangement of the
engagement members 65 on the support member 63 can correspond to an
arrangement of the electrode assemblies 30a-j on the patient's
back. For example, when the electrode assemblies 30a-j are
connected to the patient at ten sites arranged in two rows on each
side of the patient's spine, the engagement members 65 can be
arranged in two rows, one on each side of a central axis 67 (FIG.
11) that can be aligned with the patient's spine. Accordingly, the
arrangement of the engagement members 65 can guide the practitioner
to connect each coupler 60 to the proper electrode assembly 30.
Because each electrode assembly 30 is paired with another to define
a complete electrical circuit (with one electrode serving as an
anode and an adjacent electrode serving as a cathode), it can be
important to correctly match the individual cable 68 with the
corresponding electrode assembly. For example, if a given electrode
assembly 30 serving as an anode is inadvertently placed too distant
from the corresponding electrode assembly 30 serving as a cathode,
the current applied to the electrode assemblies may be too weak to
be effective. Furthermore, when the characteristics of the
electrical signals supplied to each circuit are controlled
separately, it may not be clear which circuit is being controlled
if the couplers 60 are attached to the wrong electrode assemblies.
Accordingly, the coupler support 61 can increase the effectiveness
of the electrical stimulation therapy by reducing the likelihood
that the couplers 60 will be incorrectly deployed. In other
embodiments, the coupler support 61 can have other configurations
and can support couplers having other configurations, as described
below with reference to FIGS. 23-30.
[0082] Once each electrode assembly 30 has been actuated by its
respective coupler 60 to insert an electrode into the patient's
tissue (as shown in FIG. 12), the control unit 62 provides
electrical signals to treat the patient. As described above, half
the electrodes (e.g., assemblies 30b, 30d, 30g, 30h and 30i) can
serve as anodes, and the other half as cathodes. In one embodiment,
the control unit 62 can provide a current-regulated and
current-balanced waveform with an amplitude of up to approximately
20 mA, frequency between approximately 4 Hz and 50 Hz, and pulse
width of between approximately 50 .mu.sec and 1 msec. to treat the
patient's low back pain using PNT.
[0083] FIGS. 13-22 illustrate an apparatus in accordance with
another embodiment of the invention. In one aspect of this
embodiment, an electrode introducer and an alignment member mounted
on the patient's skin provide an electrode angle of insertion
assembly controlling the electrode's angle of entry into the
patient's tissue. In a further aspect of this embodiment, an
electrode introducer 100 shown in FIGS. 13-16 and 19-21 can insert
multiple electrodes. It should be understood that the principles of
this invention could be applied to an introducer designed to hold
and insert any number of electrodes.
[0084] Twelve electrodes 102 are disposed within a magazine 103
rotatably mounted within a housing 104. In one embodiment, the
housing 104 is a two-part injection molded polystyrene assembly. As
shown in FIG. 14, the magazine 103 rotates about a hub 105 mounted
on supports formed in housing 104. A leaf spring 106 mates with one
of twelve radial grooves 108 formed in the magazine 103 to form a
twelve-position ratchet mechanism for the rotatable magazine 103 in
the housing 104.
[0085] The magazine 103 can have twelve electrode chambers 115
arranged radially about the hub 105. When the introducer 100 is
completely full, each chamber 115 contains one electrode 102. The
diameter of an upper portion 118 of the chamber 115 is sized to
form an interference fit with the wider portions 112 and 114 of
electrode handle portion 107 of electrode 102. A lower wide portion
114 of electrode 102 can be formed from a compressible material.
The diameter of a lower portion 119 of the chamber 115 is slightly
larger so that there is no interference fit between the lower
portion 119 and the electrode handle 107, for reasons explained
below. Each time the leaf spring 106 is within a groove 108, the
opening 106 of a magazine chamber 115 is lined up with the aperture
117 of the introducer 100, as shown in FIGS. 14 and 15.
[0086] A slide member 109 is disposed on a rail 110 formed in the
housing 104. Extending longitudinally downwardly from the slide
member 109 is a drive rod 111, and extending longitudinally
upwardly from the slide member 109 is a gear rack 120. The teeth of
the gear rack 120 cooperate with the teeth on a rotational gear 122
mounted about a shaft 124 extending into a shaft mount 126 formed
in the housing 104. A second set of teeth are mounted on a smaller
diameter rotational gear 128 (shown more clearly in FIG. 16) which
is also mounted about the shaft 124. The gears 122 and 128 rotate
together about the shaft 124.
[0087] The teeth of the smaller diameter gear 128 mesh with the
teeth of a second gear rack 130 extending from a
longitudinally-movable actuator 132. A spring 134 mounted between
the actuator 132 and a spring platform 136 biases the actuator 132
away from the housing 104.
[0088] To deploy the electrode assembly of this embodiment, a
flexible and compressible annular patch 140 is placed on the
patient's skin at the desired site, preferably with an adhesive
(not shown). For example, to treat low back pain using PNT, the
arrangement or montage shown in FIG. 17 may be used. In this
montage, five electrodes serve as cathodes and five serve as
anodes.
[0089] As shown in FIGS. 19 and 20, the patch 140 has an annular
rigid member 141 disposed in its center and extending upwardly from
it. The rigid member 141 has a smaller diameter opening 142 leading
to a larger diameter opening 144. The diameter of the opening 142
is slightly smaller than the lower wide portion 114 of the handle
portion 107 of the electrode 102 and slightly larger than the
diameter of the central portion 113 of handle portion 107 of the
electrode 102.
[0090] After the patch 140 is in place, the distal end of the
introducer 100 is placed against the patch 140 so that the
introducer aperture 117 surrounds the upwardly extending portion of
rigid patch member 141, as shown in FIG. 18. This interaction
aligns the opening 116 of one of the introducer's magazine chambers
115 with the opening 142 of the rigid member 141 and helps control
the electrode's angle of entry, as shown in FIG. 19. Downward
pressure on the introducer 100 compresses the patch 140, thereby
causing the upper surface of the rigid member 141 to engage a lower
surface of the magazine 103, and pressing the rigid member 141
downward into the patient's skin 22. This pressure on the patient's
skin around the insertion site can reduce the pain caused by
inserting the electrode.
[0091] Depressing the actuator 132 moves the gear rack 130
distally, which causes the gears 128 and 122 to rotate. Because the
diameter and tooth count of the gear 128 differ from the diameter
and tooth count the gear 122, the gear rack 120 moves
longitudinally a much greater distance than the corresponding
longitudinal movement of the gear rack 130. This feature enables
the electrode to be inserted its required distance into the
patient's skin using only a comparatively small movement of the
operator's thumb. Distal movement of the gear rack 120 is guided by
the movement of the slide member 109 along the rail 110.
[0092] As the slide member 109 moves distally, the drive rod 111
moves into a magazine chamber 115 until the distal end of the drive
rod 111 engages the top surface of the electrode's handle portion
107. As shown in FIG. 20, further distal movement of the drive rod
111 pushes the electrode 102 downwardly so that the sharp point 108
of the electrode 102 leaves the introducer housing and enters the
patient's skin 22 and the tissue beneath the skin. The chamber 115
provides axial stability to the electrode 102 during insertion.
[0093] When the top portion 112 of the electrode handle portion 107
leaves the smaller diameter portion 118 of the magazine chamber
115, it enters the larger diameter portion 119 of the chamber 115.
At this point (shown in FIG. 21), because the diameter of chamber
portion 119 is wider than the diameter of the electrode handle 107,
the electrode is no longer attached to the introducer 100.
[0094] Continued downward movement of the actuator 132 and the
drive rod 111 pushes the lower larger diameter portion 114 of the
electrode handle 107 through the smaller diameter portion 142 of
rigid member 141 by compressing the handle portion 114. Further
downward movement pushes the handle portion 114 into the larger
diameter portion 144 of the rigid member 141 so that the rigid
member's smaller diameter portion lies between the larger diameter
portions 112 and 114 of the electrode handle 107. This interaction
holds the electrode in place in the patient's tissue and helps
provide depth control for electrode insertion. In this embodiment,
the preferred depth of the electrode's sharp point 108 is
approximately 3 cm, although the electrode may be inserted to other
depths depending on the treatment to be performed. The slider
member 109 also acts as a limit stop at this point when it engages
the limit stop area 145 of housing 104, thereby also controlling
electrode insertion depth.
[0095] The magazine 103 can be rotated to a new insertion position
and placed against an empty patch 140 after insertion of each
electrode until all electrodes have been deployed and inserted. A
suitable electrical connector 148, such as an alligator clip, can
be electrically connected to electrode 102 through an aperture (not
shown) formed in the upper larger diameter portion 112 of electrode
handle 107 to provide electrical communication between a control
unit 150 and electrode 102 via a cable or other conductor 149, as
shown in FIG. 22. The patch 140 can provide strain relief for the
electrode 102 by preventing tugging forces on the cable 149 from
dislodging the electrode from the patient, thereby helping keep the
electrode in place. In one aspect of this embodiment, the sharp
point of the electrode is not exposed to the operator or bystander
at any point during the electrode deployment, insertion and
electrical therapy treatment processes.
[0096] The control unit 150 supplies stimulation current to the
electrodes, e.g., in the manner described in the Ghoname et al.
articles. Once again, the electrical waveform provided by the
control unit depends on the application. For example, in an
embodiment of a system providing percutaneous neuromodulation
therapy, the control unit 150 can provide a current-regulated and
current-balanced waveform with an amplitude of up to approximately
20 mA, frequency between approximately 4 Hz and 50 Hz, and pulse
width of between approximately 50 .mu.sec and 1 msec.
[0097] In an alternative embodiment, the lower wide portion of the
electrode handle can be formed from a rigid material and can have
rounded camming edges. The central annulus of patch 140 in this
alternative embodiment is either compressible or has a resilient
camming opening under the camming action of the electrode
handle.
[0098] FIG. 23 is a top isometric view of a coupler support 200
that supports or carries couplers 260 in accordance with another
embodiment of the invention. In one aspect of this embodiment, the
coupler support 200 includes a support member 220 and ten
engagement members 240 positioned at coupler locations of the
support member 220. Each engagement member 240 can removably
support one of the couplers 260. In one aspect of this embodiment,
the couplers 260 can be generally similar to the coupler 60
described above with reference to FIGS. 4-12. Alternatively, the
coupler 260 can have other configurations, such as the
configuration disclosed in co-pending U.S. application Ser. No.
09/666,931, entitled "Method and Apparatus for Repositioning a
Percutaneous Probe," incorporated above by reference. In other
embodiments, the coupler can have other configurations, for
example, those described below with reference to FIGS. 27-30.
[0099] When the couplers 260 are generally similar to the couplers
60 described above with reference to FIGS. 4-12, each engagement
member 240 can have columnar or post shape and can be removably
received in a downward facing aperture of the coupler 260. The
engagement member 240 can extend a sufficient distance upwardly
into the aperture of the coupler 260 to firmly support the coupler
260 relative to the support member 220. In other embodiments, the
engagement member 240 can have other configurations (for example,
when the coupler has other configurations), as described below with
reference to FIGS. 26-30.
[0100] The coupler support 200 can include links 250 between the
support member 220 and each coupler 260. In one aspect of this
embodiment, the links 250 can include electrical cables to transmit
electrical signals to the couplers 260 and to the patient or
recipient to whom the couplers 260 are attached. In other
embodiments, the links 250 can have other configurations, as
described below with reference to FIGS. 27-30. In any of these
embodiments, different links 250 can have different lengths to
allow the corresponding coupler 260 to be coupled to the
appropriate site on the recipient. Alternatively, each link 250 can
have the same length, so long as the length is sufficient for each
coupler 260 to be coupled to the proper site on the recipient. For
example, in one embodiment, a single support member 220 with a
single set of links 250 can be compatible with recipients ranging
in height from about 4.5 feet to about 6.5 feet.
[0101] When the links 250 include electrical cables, each link 250
can enter the support member 220 at an entry attachment point 223.
The links 250 can then pass through a cable channel 212 of the
support member 220 and exit the support member 220 at an exit
attachment point 224. The links 250 can be bundled together to form
a bundled link 251 that can be attached to an electrical connector
252 for coupling to a source of electrical potential.
[0102] In one embodiment, the support member 220 can include an
upper portion 210 bonded to a lower portion 211. The upper portion
210 can include the cable channel 212 and the engagement members
240. The support member 220 can be formed by molding the upper
portion 210, inverting the upper portion 210, and laying a cable
harness (which includes the bundled link 251 and the individual
links 250) into the cable channel 212. The lower portion 211 can be
attached to the upper portion 210 (for example, in an overmold
process) to fix the harness into the support member 220. In other
embodiments, the coupler support 200 can be formed with other
techniques. In any of these embodiments, the support member 220 can
include a flexible, soft durometer, bio-compatible, thermoplastic
elastomeric material, such as Sanoprene.RTM., available from
Advanced Elastomeric Systems of Akron, Ohio. Accordingly, the
support member 220 can conform to the shape of the recipient's
body, as described below with reference to FIG. 24.
[0103] In a further aspect of this embodiment, the shape of the
support member 220 and the positions of the engaging members on the
support member 220 can be configured to aid the practitioner in
connecting each coupler 260 to the correct corresponding coupling
site on the recipient's body. For example, when the coupler support
200 is configured to administer electrical therapy to the
recipient's back, the support member 220 can have an axial
elongated portion 221 aligned with a central axis 270. The support
member 220 can further include two transverse elongated portions
222 (shown as a first transverse elongated portion 222a and second
transverse elongated portion 222b) arranged transverse to the
central axis 270. In one aspect of this embodiment, the coupler
support 200 generally and the elongated portions 221, 222 in
particular can be configured to be spaced apart from corresponding
coupling sites on the recipient's back, so as not to interfere with
the operation of attaching the couplers 260 to the recipient. For
example, in one embodiment, the axial elongated portion 221 can
have a length of about 11 inches .+-.0.25 inch (measured from the
exit attachment point 224). The transverse elongated portions 222a,
222b can have lengths of about 6.8 inches and about 7.5 inches,
respectively, .+-.0.25 inch. In other embodiments, the elongated
portions 221, 222 can have other dimensions. In any of these
embodiments, each coupler 260 can be positioned proximate to its
corresponding coupling site to aid the practitioner in connecting
the couplers with the appropriate coupling site, as described below
with reference to FIG. 24.
[0104] FIG. 24 is a partially schematic, top isometric view of the
coupler support 200 (shown in phantom lines) placed in position on
the back of a recipient. For purposes of clarity, the coupler
support 200 is shown schematically in FIG. 24 without the couplers
260. In one aspect of this embodiment, the central axis 270 of the
coupler support 200 is aligned with a body longitudinal axis 271
(such as the spine) to position the coupler support 200 proximate
to a coupling area 280 on the recipient. The coupling area can be
on the recipient's back (as shown in FIG. 24) or, alternatively the
coupling area can be on the recipient's neck, head, leg or other
body part. When the coupler support 200 is in position on the
coupling area 280, the elongated portions 221, 222a and 222b can
flex to conform to the shape of the recipient's body in the
coupling area 280. Accordingly, the coupler support 200 can be less
likely to be dislodged from the recipient's body and can more
accurately align the couplers 260 with the appropriate portions of
the coupling area 280.
[0105] The coupling area 280 includes a plurality of coupling
positions or sites 281 (shown as 281a-j) at which a corresponding
plurality of electrode assemblies 230 (shown as 230a-j) are
attached. In one embodiment, the electrode assemblies 230 are
arranged in cathode/anode pairs with five circuits formed by
electrode assembly pairs 230a and 230b; 230c and 230d; 230e and
230f; 230g and 230h; and 230i and 230j. Once the coupler support
200 is in position on the recipient's back, each engagement member
240 (shown as 240a-j) is positioned proximate to its corresponding
electrode assembly 230a-j. For example, those engagement members
240 that are to be coupled with electrode assemblies 230 close to
the body longitudinal axis 271 are positioned close to the central
axis 270 of the coupler support 200. Those engagement members 240
that are to be coupled with electrode assemblies 230 further away
from body longitudinal axis 271 are positioned further away from
the central axis 270 of the coupler support 200. Accordingly, many
of the couplers 260 are positioned closer to the one corresponding
electrode assembly 230 to which that coupler 260 is to be connected
than to any other electrode assembly. As a result, practitioners
will be less likely to link the couplers 260 to the incorrect
electrode assembly 230.
[0106] FIG. 25 is a top plan view of the coupler support 200 with
the couplers 260 removed so that the tops of the engagement members
240a-j are visible. In one aspect of this embodiment, the
engagement members 240a-j can be marked to indicate which circuit
the corresponding couplers 260 are connected to. For example, the
engagement members 240a and 240b can be marked with a numeral "1"
to indicate that the couplers 260 removed from these engagement
members are connected to the recipient to form circuit number "1."
An advantage of this arrangement is that if the control unit 62
(FIG. 9) indicates that circuit number "1" is faulty or defective,
the practitioner can easily narrow the field of potentially faulty
couplers 260 to the two couplers 260 removed from engagement
members 240a and 240b.
[0107] In another aspect of this embodiment, the coupler support
200 can include other features to further aid the practitioner in
attaching the couplers 260 to the correct coupling site 281. For
example, the engagement member 240a can be can be offset to the
right side of the central axis 270 and the engagement member 240b
can be offset to the left side of the central axis 270 so that the
practitioner will be more likely to connect the corresponding
couplers 260a, 260b (FIG. 24) to the appropriate coupling site
281a, 281b. In a further aspect of this embodiment, the engagement
members 240a, 240e, 240f, 240i and 240j positioned on the right
side of the central axis 270 can have a different color than the
engagement members 240b, 240c, 240d, 240g and 240h positioned on
the left side of the central axis 270. As is also shown in FIGS. 24
and 25, the overall shape of the coupler support 200, and in
particular, an outline defined by the positions of the engagement
members 240, is generally similar to an outline defined by the
positions of the coupling sites 281. In other embodiments, for
example, when the coupler support 200 is configured to rest on the
recipient's leg, neck or head for therapy to these regions, the
outline defined by the engagement members can also correspond to
the outline defined by the coupling sites. In any of these
embodiments, the relative longitudinal and lateral locations of the
engagement members 240 can correspond at least roughly with the
relative longitudinal and lateral locations of the coupling sites
281 on the recipient's body.
[0108] FIG. 26 is a top isometric view of a portion of a coupler
support 300 having a transverse elongated portion 322a with an
engagement member 340 in accordance with another embodiment of the
invention. The overall shape of the coupler support 300 can be
generally similar to that described above with reference to FIGS.
23-25. In one aspect of this embodiment, the engagement member 340
can include an aperture 341 positioned to receive the housing of a
coupler, such as the coupler 260 described above with reference to
FIG. 23 or the coupler 60 described above with reference to FIGS.
4-8. In still a further aspect of this embodiment, the engagement
member 340 can include a pair of entrance slots 342 positioned to
receive the pegs 70 (FIG. 5) of the coupler 60. Once the pegs 70
have been moved into the entrance slots 342, the coupler 60 can be
rotated clockwise to move the pegs 70 into transverse locking slots
343. Accordingly, an advantage of this arrangement is that it can
securely, yet removably, engage the coupler 60.
[0109] FIG. 27 is a top isometric view of a portion of a coupler
support 400 having a transverse elongated portion 422a with an
engagement member 440 in accordance with another embodiment of the
invention. In one aspect of this embodiment, the engagement member
440 can include an aperture 441 configured to receive a clamping
coupler 460, such as an alligator clip. The clamping coupler 460
can be attached directly to a percutaneous acupuncture needle 402
or another percutaneous or transcutaneous device. When the clamping
coupler 460 is not attached to the needle 402, it can be removably
positioned in the aperture 441 while remaining connected to an
electrical link 450, such as a cable. In an alternate arrangement
shown in FIG. 28, the coupler support 400 can include an engagement
member 440a having a post shape. In one aspect of this embodiment,
the clamping coupler 460 can be clamped to the engagement member
440a to support the coupler 460 relative to the coupler support
400.
[0110] In one aspect of the embodiments described above with
reference to FIGS. 27 and 28, the clamping coupler 460 can be
attached to a percutaneous electrode, such as the electrode 102
described above with reference to FIG. 22. Alternatively, the
coupler 460 (or other couplers) can be attached to a transcutaneous
electrical nerve stimulation system. In still a further embodiment
(shown in FIG. 29), a clamping coupler 660 can be clamped to a
diagnostic electrode, such as a patch electrode or an EMG needle
electrode 630 of the type available from SLE of South Croydon,
England. A plurality of the couplers 660 (one of which is shown in
FIG. 29) can be connected to a support 600 (shown schematically in
FIG. 29) in a configuration generally similar to that described
above with reference to FIG. 23 and/or FIG. 11. The support 600 can
be connected with a bundled link 651 to a care unit 690. The care
unit 690 can include a diagnostic instrument that receives
electrical signals from the coupler 660, rather than providing
electrical signals to the coupler 660. Accordingly, the support 600
can aid the practitioner in coupling the plurality of couplers 660
to the correct corresponding electrode 630.
[0111] FIG. 30 is a partially schematic view of a coupler support
700 that can aid the practitioner in delivering medicament to a
plurality of coupling sites on the recipient in accordance with
another embodiment of the invention. Accordingly, the coupler
support 700 can include a plurality of medicament links 750 (one of
which is shown in FIG. 30), such as a length of drug delivery
tubing. Each link 750 can include a coupler 760 for attaching to a
needle or other drug delivery device 730 inserted into the
recipient. The individual medicament links 750 can be bundled
together to form a bundled link 751 which is connected to a care
unit 790. The care unit 790 can include a pump, drip bag, or other
arrangement for providing liquid medicament to the coupler support
700 and the recipient.
[0112] A feature of embodiments of the coupler support arrangements
described above with reference to FIGS. 11 and 23-30 is that the
supports are configured to position the couplers proximate to the
appropriate coupling location. Accordingly, practitioners,
including relatively inexperienced practitioners, can be less
likely to connect the couplers to an incorrect coupling location.
An advantage of this arrangement is that the couplers can provide
more reliable and/or more efficacious therapy and/or diagnostic
information. A further advantage is that the practitioner can more
quickly connect the couplers to the recipient, increasing the
efficiency with which the practitioner can provide therapy and/or
diagnostic information.
[0113] Still a further advantage of embodiments of the coupler
support described above is that a single support can accommodate a
wide variety of applications. For example, a single support can be
used with recipients ranging in height from about 4.5 feet to about
6.5 feet, as discussed above. A single coupler support can also be
used with recipients having a wide variety of body shapes. Still
further, a single coupler support can be positioned on recipients
having a variety of postures. For example, a single coupler support
can rest on the recipient's back whether the recipient is prone,
leaning over, or partially upright, while still allowing the
couplers to be connected to the appropriate coupling locations.
[0114] From the foregoing, it will be appreciated that, although
specific embodiments of the invention have been described herein
for purposes of illustration, various modifications may be made
without deviating from the spirit and scope of the invention. For
example, the couplers can be connected directly to the recipient
rather than being connected to an intermediate device such as an
electrode (i.e., the electrode can be integrated with the coupler).
The coupler locations of the support member can include posts or
columns, apertures, or any other feature that removably carries the
couplers. Accordingly, the invention is not limited except as by
the appended claims.
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