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Patent 2097857 Summary

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(12) Patent Application: (11) CA 2097857
(54) English Title: FES METHOD IMPROVEMENTS
(54) French Title: AMELIORATION DE LA METHODE FES (FUNCTIONAL ELECTRICAL STIMULATION)
Status: Deemed Abandoned and Beyond the Period of Reinstatement - Pending Response to Notice of Disregarded Communication
Bibliographic Data
(51) International Patent Classification (IPC):
  • A61N 1/36 (2006.01)
(72) Inventors :
  • HAUGLAND, MORTEN (Denmark)
  • HOFFER, ANDY (Canada)
  • SINKJAER, THOMAS (Denmark)
(73) Owners :
  • MORTEN HAUGLAND
  • ANDY HOFFER
  • THOMAS SINKJAER
(71) Applicants :
  • MORTEN HAUGLAND (Denmark)
  • ANDY HOFFER (Canada)
  • THOMAS SINKJAER (Denmark)
(74) Agent: GOWLING WLG (CANADA) LLP
(74) Associate agent:
(45) Issued:
(22) Filed Date: 1993-06-04
(41) Open to Public Inspection: 1994-12-05
Availability of licence: N/A
Dedicated to the Public: N/A
(25) Language of filing: English

Patent Cooperation Treaty (PCT): No

(30) Application Priority Data: None

Abstracts

English Abstract


1
ABSTRACT OF THE DISCLOSURE
The motor function of a partially or completely paralyzed
muscle is restored by implanting a nerve electrode, e.g. a
cuff electrode, for sensing electrical signals from a sensory
nerve which innervates a part of the body which is phy-
siologically related to the partially or completely paralyzed
muscle, stimulating the paralyzed muscle by means of a muscle
stimulator, sensing by means of said nerve electrode an
electrical signal from the sensory nerve, producing a further
control signal for reactivating the muscle stimulator
dependent on the electrical signal sensed after the
expiration of a predetermined period of time after the
stimulation of the muscle, and restimulating the paralyzed
muscle in response to said further control signal. The
electrical signal is amplified, band-pass-filtered, and
optionally rectified and bin-integrated when producing said
further control signal. The bin-integration is performed by
means of an integrator having an adjustable integration
period, said integrator being synchronized with the muscle
stimulator. A secure grip of an object through FES of a
partially or completely paralyzed muscle which is involved in
holding the object, is obtained by detecting the start of a
slip of the object from the ENG signal from the nerve
electrode and immediately upon detection of the start of a
slip producing or modifying a control signal for activating a
muscle stimulator stimulating the paralyzed muscle. The start
of the slip is detected automatically as an event that
exceeds a predetermined threshold value in that the ENG
recorded from the sensory nerve is processed using analog or
digital circuitry, and a low pass-filtered version of the
ENG, delayed by a number of samples, is subtracted from the
actual electrical signal sensed, thereby removing unrelated
background activity from the signal.


Claims

Note: Claims are shown in the official language in which they were submitted.


CLAIMS
1. A method for at least partially restoring the motor
unction of a partially or completely paralyzed muscle, said
method comprising
implanting a nerve electrode for sensing electrical signals
from a sensory nerve which innervates a part of the body
which is physiologically related to the partially or
completely paralyzed muscle
stimulating the paralyzed muscle by means of a muscle stimu-
lator
sensing by means of said nerve electrode an electrical signal
from the sensory nerve
producing a further control signal for reactivating the
muscle stimulator dependent on the electrical signal sensed
after the expiration of a predetermined period of time after
the stimulation of the muscle, and
restimulating the paralyzed muscle in response to said
further control signal.
2. A method according to claim 1 wherein the nerve electrode
is a nerve cuff electrode.
3. A method according to claim 1 or 2 wherein the electrical
signal is amplified, band-pass-filtered, and optionally
rectified and bin-integrated when producing said further
control signal.
4. A method according to claim 3 wherein the bin-integration
is performed by means of an integrator having an adjustable
integration period, said integrator being synchronized with
the muscle stimulator.

41
5. A method according to any of claims 1-4 wherein the part
of the body is innervated by the sensory nerve comprises a
skin area.
6. An FES system for at least partially restoring the motor
function of a human having at least one partially or com-
pletely paralyzed muscle, said system comprising:
a stimulator means for stimulating the paralyzed muscle or
muscles
an implantable nerve electrode for sensing electrical signals
from a sensory nerve which innervates a part of the body
which is physiologically related to the partially or
completely paralyzed muscle or muscles, and
control means responsive to the electrical signals sensed
from said sensory nerve after the expiration of a
predetermined period of time after the stimulation of the
muscle for producing a further control signal for
reactivating said stimulator means.
7, An FES system according to claim 6, wherein said control
means comprises means for amplifying, band-pass-filtering,
and optionally rectifying and bin-integrating the sensed
electrical signal and means for producing said further
control signal in response to said bin-integrated electrical
signal.
8. An FES system according to claim 7, wherein the bin-
integration is performed by means of an integrator having an
adjustable integration period, said integrator being syn-
chronized with the stimulator means.
9. A method for providing a secure grip of an object through
FES of a partially or completely paralyzed muscle which is
involved in holding the object, comprising

42
implanting a nerve electrode for sensing electrical signals
from a sensory nerve which innervates a park of the body
which is physiologically related to the partially for
completely paralyzed muscle,
detecting the start of a slip of the object from the ENG
signal from the nerve electrode,
and immediately upon detection of the start of a slip
producing or modifying a control signal for activating a
muscle stimulator and stimulating the paralyzed muscle in
response to said control signal.
10. A method according to claim 9, wherein the start of the
slip is caused by an external change in the load or weight of
the object.
11. A method according to claim 9, wherein the start of the
slip is caused by an internal disturbance such as fatigue.
12. A method according to claim 9, wherein the start of the
slip i caused by a change in the frictional coefficient of
the skin, such as due to sweating.
13. A method according to any of claims 9-12, wherein the
start of the slip is detected automatically as an event that
exceeds a predetermined threshold value.
14. A method according to claim 13, wherein the ENG recorded
from the sensory nerve is processed using analog or digital
circuitry, and a filtered version of the ENG is subtracted
from the actual electrical signal sensed, thereby removing
unrelated background activity from the signal, the resulting
calculated signal being identified as a signal related to the
start of a slip if it exceeds a predetermined value.

43
15. A method according to claim 14, wherein the filtered
version of the ENG is delayed by a number of samples and then
subtracted from the actual signal sensed.
16. A method according to claim 14 or 15, wherein the
filtered version is a low-pass filtered version.
17. A method according to any of claims 9-16 wherein the
actual signal is an unfiltered signal or a signal which has
been subjected to filtering with a shorter time constant than
the version subtracted.

Description

Note: Descriptions are shown in the official language in which they were submitted.


20~78~7
FES METHOD IMPROVBMENTS
The present invention relate~ to FES method im~xovement~. I~
one aspect, the pre~ent invention ~elate~ ~o a no~el
Rrinciple ~or r~coxdi~ and using natur~1 sensory nexve
a~tivity from pe~ipheral nerve~ ln a system ~or functiona~
electrical stlmula~ion (FE~) wherein the artifac~ ~ignal
generated by muscle stimulation i~ minimize~. In another
aspect, the invention relates to the utilization of a
specific slip-related ~ignal ~or providing a secure grip o~
a~ object throu~h FES os a p~r~ical~y or com~letely paralyzed
muscle which i8 involved in holding the object.
GE~ERAL BA~KGRo~D
It i6 po6~ible to 6timulate paxalysed muscles electrically
and in this way make paralysed limb~ perform functional
lS moveme~ts. T~is tec~nique, called functional electri~al
stimulation (FES), has been known for de~ade~ and se~eral
research grou~s worldwide are currently in~olved in
developing the techniqus. The research i~ dire~ted more and
more towardfi the development of implantable sy~tem~ tha~ use
alo~ed-loop co~trol, since moat pr~viou~ system~ ~ave
su~f~ed from practical and co~metlcal problems becau6e of
the external equipment a~d ~he dif~iculk control of
stlmulated m~le~. To de~elop ~uch 6ystems, it i~ ne~essary
to develop ~nsorg that are ~uitable ~or long-term
imp~an~tion. Some necessary fe~ture~ of such ~enso~s a~e
biocompatibili~y, reliability, durab~lity and small size.
~ry faw artificial sensor~ have these ~eatures.
For a ha~d-grasp prosthesis or foot-drop pxosthesis, nerve
cuf f elec~rode~ might be implanted on lndi~idual nerves in
30 the hand or foot. ~h~3 aign~ expected to tell when a~
object }~as co~ltact with the ski~ (for example in the fins~ers,
the nerve ~ig~al response when the object slips, and in the
foot a~ impact between the sole a~d the ground surface). The
~i~n~ n thus in a hand-grasp prosthesis be used f or i . e .

2~7~7
updating the stimulation intensity if a ~rasped object ~tarts
to 61ip and also to detect the minimum stimulation intensity
necessary for holding an object, and in the ~oot the ner~e
signal can be u~ed to activate the ankle dorsiflexor muscle
at the appropriate time du~ing ~ step-cycle.
Human ~kin, joints and mu~cle~ a~e equipped wi~h numerous
se~sors t~at e~able us to sense our ~urrounding~ ~nd the
st~te of our body. If this info~m~tio~ can be reliably
recorded, it i9 pos~ible to use these _~O~ Lnn~ ~ to
provide feedback si~nals to an F~S system. The technic~l
problem~ of recording the information have been ~ub~tantlal
because of the small size o~ the nerve fibre~ and the low
amplitude of the ~i~n~ hat i~ to be recorded compared to
the noi~e introduced b~ ~timulation o~ ~u~ ne~r~y.
US Pate~t 4,750,499 by J.A. Ho~fer de~cribed an FES Yystem
for p~tially re~toring th~ motor ~un~ion of ~ per~on h~ving
p~r~lyzed mucles, said method comprising implantin~ a ~orce
sensor ~ompxi~ing a nerve electrode for ~ensing electrical
signals pri~ily f~o~ ~ech~noreceptors ~s~ociated with a
2~ ~eripheral sen~ory nerve that supp].ie6 glabrous ~kin of the
pex~on ha~ing the paralyzed mu6cle~;, 6ensing electrical
sign~ls ~ia ~aid force sen~or, proclucing an alectrical
c~n~ol ~ign~l ~or actl~atin~ a mu~cle stimulator i~ response
to the electrical ~ignal~ sen6ed by ~aid ~erve el~ctrode, ~nd
~5 6tlmulating the p~r~lyzed ~usc~le~ in ~ccor~n~e with s~id
contxol ~i~nal. In a practical implementation of this ~ystem
artifact6 ~uch ~ stimulation arti~acts and mus~}e respon~e~
du~ to the ~timulation will, however, be supe~imposed on the
electro~euro~ram (ENG) ~ignal. If the nerve cuff electro~e
must be located in clo~e pro~imity to ~timulated mu6cle, a~
may often be the c~e, th~ EN~ ~ignal will most l~kely be so
disturbed ~hat the proposed sy~tem can not function. ~ ~
In an ~t~empt to xeduce the noi~e introduced by 6timulation ~ :
of muscles nearby, Knaflitz ~nd ~exletti ~ ) have
developed ~ de~ice which eature~ the following: a) a
;:: . :
:. . . : , :
. . .

20g78~37
~'hybxid" outpu~ stage, op~ical isol~tion of both ~he
~timulation output stage and o~ the inp~t ampllfie~ stage,
monophasic or bipha~ timulation output, artif~ot
~uppres~ion obtai~ed by slew rate limiting in the isolated
~tage and signal bl~nking i~ the ~round re~erred stage, and
~i~gle and double differential de~ection o~ the myoelectrlc
sig~al.~ Howe~er, this hae not been a useful approach as the
~witche~ in mo~ ~a~es created more noi~e than ~ras removed
when applied to the high gain ~10000~) ampl~fiers used in
theix ~tudy.
DESt::RIPTION OF ~IE INVEN~IO~
A main aspect of the pre~ent invention relate~ to a method
for a~ lea~t partially restoring the motor fun~tion of a
partially or completel~ p~ralyz~d mu~cle, said method
comprising implanting a nerve electrode for ~e~ing
electrical signals from ~ ~en~ory ner~e which innervate~ a
part of the body which i6 physiologically rel~ted ~o the
partially or completely paralyzed muscle, stimulating ~he
paralyzed muscle by means of a mus~le stimulator, ~en~in;T by
mean~ of said ~er~e electrode an electrical signal from the
sensory nerve, producing a furthe~ control ~ign~l for
reac~ivati~ the muscle ~tl~ulator depende~t on the
electrical signal sensed after the expiration of a
predetermined period of time after the stimula~ion o~ the
muscle, and rest~mulating the p~ralyzed muscle in response ~o
~aid furth~r control ~ignal.
An importan~ ~eature of ~he present inve~tion is that dur~ng
predetermined period o~ time after the ~timulation o~ the
muscle or muscle~, esRentially no electrical ~ignal i8 sensed
~rom the sensory nerve, i.e. the further control signal for
reactivatin~ the muscle ~timulator i~ dependent on~y on the
electrical signal sensed after the expiration of a pre~
determined period of time ~fter the stim~lation o~ the muscle
or ffl~scles~ The objective of thi~ is to a~oid or minimi~e th~
artifact cont~mination ~y the electromyo~ram (EMG) on the EN~

2~978~7
signal. Examples on how this can be aco~pli~hed are described
in more detail in the followiny.
T~e invention ~an al~o be de~cribed a~ a FES ~ystem for at
least partially restoring the rnotor function of a hum~n
5 having ~t least one partially or ~ompletely paralyze~ muscle,
~aid system compr~sing a stimulator mean~3 ~or stimulating the
p~ral~r2;ed m~scle or mu6cles ~ ~n impla:ntable ner~re electrode
for s~n~ing elec~rical ~ignals from a sen~ory nerve whi~h
innerv~te~ a part o~ the bod~ which i~ phy~iologicRlly
10 ~elated to the partially or c:ompletely paralyzed nuscle or
muscle~, and
control means re~ponsive to ~he electrical s~gnal~ sens~d
~ro~n said se~sory ner~e a~ter the expiration of a pre-
detennined p~riod of time after the ~tir~ulation of 'che mu~cle
or mu~cle~ ~or produci~g a ~urthe~ control signal for re-
activating said stimulator mean~.
In a presently preferred embodiment, the invention relate~ to
a FES ~ystem as described above w~e~ei~ said con~rol m~ans
20 compri~es means for amplifying, band-pasE~-filtering, and
optionally reatifying and bln-integrating the sensed electri-
cal signal and means for producing said further control ~ig-
nal in response to ~aid bin-integrat~d electxical sig~al. As
an example, the bin-inte~ration in ~he FBS sys~em according
to the inve~tion can be performed ~ mean~ of an integrator
having an adjustable integration period, ~aid integrator
being synchronized wi~h ~he s~imulator means.
More than on~ par~ially ox completely paraly~ed muscle can be
stimulalted by the method ox ~ES ~ystem o~ the invention, In a
particular e~bodiment whi~h i6 described in more detail in
Example 1, the recordin~ cu~ was placed on the tibial ner~e
~nd the ~o~r plan~Ar~lexor muscles were s~imul~ed in turn by
the co~p~ter. T~e present ~n~ention thu~ ~lso provides ~
method ~or at lea~t partially re~tori~ the motor ~unction of :
~evexal paxtially or compleSely p~ralyzed muscles, said
method comprising impl~nting a nerve electrode for senslng
~,. . .,: i ,

2~7~7
electrical sig~ om a sensory nerve which innervate~ a
part of the body which i~ ph~siologic~lly related to the
parti~lly or completely par~lyzed mu~les, stimul~ting one of
the paralyzed musc~e~ by means o~ a musc~e ~timulator,
5 ~en~ing by means of s~id nerve electrode an electric~l signal
from the ~n~oxy nerve, producing a further con~rol ~ign~l
~o~ ~eactivating ~nother muscle ~timulator ~ependent on ~e
electrical 6ig~al sensed after ~he expiratlon of a pre-
determi~ed period of ~ime ~ft~r the stimulation of ~hè
muscle, and restimulatin~ another paralyzed mu~cle ~n
response to said further control ~isnal. In an alternative
em~odiment, ~everal partially or completely paralyzed muscles
may be stimulated 6imultaneou31~, the further control ~i~nal
for reactiva~in~ the muscle gtimulator or mus~le stimulators
bein~ depe~dent on the electrical ~ignal sen~ed after the
expiration of a predete~mined period of tim~ after the first
stim~l~tion of the mu6cle6. In further embodiments, the
method may compri~e more than one nerve electrode coupled to
one or ~everal mu6cle ~timulator~, i.e. the method may com-
prise the ~ombination o~ two or moxe ~S system~ o~ theinvention workin~ to~ether i~dependently or integrated e.g.
by mean of a computer in an appropriate way.
A ~uitable nerve electrode for se~ing electrical signal~
from a se~o~y nerve can be e.g. a cuff electrode implanted
25 around a peripheral se~ory nerve. In such a cuff elect~ode,
which may be a split cuff or a 6piral cuff elec:trode, the
~tability of th~ re~orded ~ig~al i.~ s~able enough to be used
i~ a FES sys~em. Also othe~ ~uitable nerve electrodes such as
intrafa~cicular ox in~neural electrode ~Hoffer and ~aug-
land, 1~92) m~ be used in the meth~d or FEs system ~ ~heinvention.
In ~ presently pre~erre~ ~mbodime~t, the method according to :~
t~e in~en~on i~ ~ method wh~rein the electrical si~nal i8
ampli~ied, band-pass-fil~ered, and optionally rectified and
bin-int~grated when producing 6aid further control ~i~nal.
- ~ . . : ., .: .
;.... . .. . .. . ... . . . . .. .. .

2~g7~7
The bin-inte~r~ n can be performed b~ mean~ o~ an inte-
grator having an adjustable integration period, said lnte-
grato~ being syn~hroni~ed with the ~uscle ~timul2tor or
~uscle stimulator~. The sensed electrical signal i~ generally
S inte~rated i~to a single ~alue to produce the ~urther control
slg~al .
Within the ~cope of the prese~t invention are al~o msthods
w~erein the EMG artiact i~ minimized by other ~ethod~ such
as subtra~ting the EM~ nal recorded ~y other, ne~r~y e~ec-
0 trodes ~rom the ENG sign~l prior to the proce~ing b~ themethod of the i~ention. By the use of ~ch fuxther methods
for artifact suppre~Rion, the predetermined time period
during which essenti~lly no ele~t~ ignal i8 6en~ed ~rom
the æen60ry nerve can be mi~i~ized.
~n a presently pre~erred embodime~t, the p~rt of the body
innervated by the eensory ner~ compriæe~ a skin area.
However, it i~ contemplated that the method of the i~ve~tlo~
will alæo be u~e~ul when t~e part of the body innervated by
the ~en~ory ner~e compri~es ne~ve~ f~om proprioceptors æuch
as muæcu~ar spindles, Golgi tendon organ~ or join~ recep~or~.
The m~cle ~timul~tion ~a~ be ~ompli~h~d by any suitable
muscle ~timulator. ~or a re~lew, ~ee e . ~ nes a~d Creery,
1~90. ~lso other stimulator~ with appropriate ~eatures can be
uæed in the method of the invention. .
6enerally, for hu~an application~ it i8 pre~ently pr~ferred
that the ætimulation signals should ~e genera~ed ~ ~
~regue~cy o~ about 5-50 E~z, more preferably about 10-20 Hz.
The ~cle re~timul~tion provided by the further stimulation
~on~ol ~i~nal can be ~axied e.g. by ad~us~ing the amplitude
of the stimulation pul~e~. Al~o~ ~he pulse wid~h o~ the
~timul~ion pulse~ c~n be ~aried. Ini ~he presently pre$erred
embodiment~, the pul~e width of the ~ti~ulatio~ipulses i3 i~
the magnitude of about 100 - 300 microseconds, su~h as ~50 -
~0 micros~conds, e.y. 200 microsecond~. Al~o the fre~ue~cy
,''` ` :` : . ' `: ~ ' ' '`. :
: .,:,., : .. : ' ' .. ` :, ` ~
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2~9~7
of the ~ti~ul~tion o~ the mu3cle or muscle~ ma~ be varied~
~owe~ex, i~ a simplified embodiment of the method of the
in~ention, the frequency of the stimulatiôn of the m~scle or
mu~cles is sub~tantially con~tant.
Based upon th~ information in the present ~pecifi~ation a~d
claim~ will be within the skill of th~ pe~son skilled in
~he art to determine a suitable prede~ermined period of time
after the ~timulation of the mu~cle du~ing whi~h e~entiall~
no electrical ~ign~l should be ~ensed from the sensory nerve.
0 Thl~ pe~iod will of course ~ary depending on the diagnosi~ of
the patient, the particular paralyzed m~cle or muscles which
are ~timulated, the distance and orientation ~e~ween the
nerve electrade and the mu6cle stimulator, ~he ~ype o* the
~timulation el~ctrode~, the maximum current neede~ for
stimulation e~c. ~enerally, the period i~ cont~pla~ed to ~e
about 3-10 ms or in certain circumstance~ ~ven 1~8 or more
after the stimulation of the ~uscle. ~s a starting poin~, it
is proposed that the time period i~ set to be about 5-7 ms.
Example 1 describes a cat model ~.o validate reduction of
~0 artifact~ by th~ m~thod of the inv~3ntion, and ~xample ~
de~cribes a ~imple F~S system ~or correction o~ footdrop in a
hemiplegic spasti~ male.
The techni~ue used in the present lnvention i~ ~hown ~hema-
tically in Figur~ lA. A n~rve electrode ~uch ~ a tripolar
cu~f elect~ode, i~ implanted on a ~e~30xy nerve t~at innex-
~ates the part of the body of interest, e.g. skin, joint(s)
ox mu~cle~) or a combination the~eof. ~ dif~ere~tial
amplifier (AMP), with high common-mode reJection and a gain
between o.I million and 1 million, a~plifies the ~ignal
recorded from the ~en~er and the two connected
end-ele~trodea. The amplifier has ~ bandwidth from ~00 Hz to
10 kHz, comparabl~ to the bandwidth of the nerve ~i~nal. Thi~
~ignal i~ then rectified in a ful~-wave act~ve rectifier
(R~iI). When nearby mus~les are ~timulated, this signal
una~oidab}y cont~i~s large peaks o~ stimulation a~ti~acts ~if
~ . , .

^ 8 2097~7
sur~ace ~timulation is ~sed, t~e ~timulation pul~e~ will
t~pically have an amplitude of 100 v, whereas the recorded
ne~v~ ~ignal is ln the order of 1 ~V~.
After ampIif~cation of the signal from the nerve cu~f ele~- :
trode, further proces~ing i5 ne~e~sary to remove noise ~nd
artifact~, produce a ~ignal t~at ~epresen~s the over~ll
acti~ity in the ~er~e, and change that siynal into a cont~ol
~igmal to the ~timulator. An ~xample of a ~ircuit to do thi~
h~ been implemented for a portable ~oot-drop corre~tion
system, ~ased on analog components.
The circuit consi6ts of the followin~ parts as shown in the
block diagxam (Fi~ure ls):
HP-filter
Thi~ high-pass filter is m~inly nece~ary ~ecause of ~ossible
offset voltages ~rom the ampli~ier ~ha~ supplies the cir~uit
with information from the electrode. However, ~in~e ~ere
mi~ht be some ~nintended muscle acti~ity in the recorded
~ignal, the cutof~ ~re~uency has been set high, to
approximately 600 Hz.
~0 Active rectifier
Af~er the hig~-pass ~ilter, the ~ignal is now without DC
off~et and i~ then full-wave rectified, a~ the first stage of
producing an envelope of the nerve ~ al. The recti~ier is
acti~e, i.e. it doe~ not lose inform~tio~ beca~se o~ ~ diode-
~oltage drop for negati~e ~alues, as would a p~iverecti:Eier.
Bin-inte~.r~tor with timing circuit
In ~he pre~ent embodiment the bin-integ~ator is the key part
o~ the arSi~act remo~al sche~e. It ~on~ists of an int~grator
30 that can be re~et, as controlled by an external
IB2376B~ /AS/lg93o6o4 ::
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::;' , :: ' : ,
:,:: , :

2~7~;~7
synchroni~ation signal and the timer circuit ~eing part o~
the integ~at~r. When a muscle i~ electrically stimulated, the
stimulator gen~s a sy~chroniza~ion signal to the bin-
integrator. Thi~ nal is high for t~pically 100 ~8 duri~y
each stimulus. D~rin~ thi6 time, ~he i~p~ to the integrator
ia di~conne~ed by U4~ (see Figure lC), re~ulting in the
value on the output of the i~tegrator being kept constant.
When the synchronization signal end~, it ~ta~ts a timer (U3A
on the circuit diagram) (Fi~ure lC) tha~ short-circuit~ the
capacitor i~ the integrator (C3). The tim~r i8 ad~u~table up
to 27 ms. During thi~ p~riod, that i~ adjustable in du~ation
b~ P~, the integrator i~ reset, and thus ignores the signal.
The timer is norm~lly adjusted to time ou~ ri~ht a~ter stimu
lation arti~cts that contaminate the si~nal have ~ied out.
Then the integrator ~tart8 to integrate during a perlod which
the ~ignal contain8 only neu~al i~formation wi~hout artifacts
until a new synchronization ~ign~l appears from the ~timula-
tor. ~uring the time the integrator outpu~ i8 kept con~tant,
the switches U4~ ~nd U4D co~ec~ it to the hold-circuit made
up by C4 and U2C, ~hereby ~oring the fin~l value of the
inte~ration. The ~equence o~ the~e values is ~s~ally re~exred
to as the recti~ied, bin-integrate~l ENG, or jus~ E~G, and
i8 a direct mea~ure of the overall activity ~n the nerve.
~ndpa~s filter
25 It is nece~sary to process further the RE~-ENG ~o produce a
cc~ntrol signal for the stimulator. In the present em~odiment,
the fir~t step is band-pa~ filtering to produce a ~ooth
signal that woul~ reflect overall change~ in the nerve
activity rather than ~he absolute ~ctivity. ~his is done by
ca~cadin~ tw~ pa~Bive first order ~ilte~ - a lQwpass section
(R10 ~nd ~7) with ~ ~utof~ f~equency of ~pproxim~tely 20 Hz,
and a highpa6s ~ection (~5 and R~0) ~et at approximately
1 H~. An inverting amplifler with gain = lo then ~ollows
~ecause o~ loss o~ signal amplitude in ~he passi~e ~ilte~s.
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lo 2897~7
Acti~e rec~ifier
~sually the astest change~ in nexve ac~i~it~ are increases
(as when the heel ~trikes the floor), but sometimes ~
decrease could gi~e ~he most p~ominent peak in ~he highpass
fil~ered ox differentiated nerve activity. To increa~e
detection reliability, both the positi~e an~ negative peak
are used for detection by rectifying the si~nal firet. ~ain,
the rectifier i~ a~tive in order no~ to lose infoxma~ion
because o~ diode-~oltaye drops.
Comparator
After highpas~ filtering and rectification, heel-s~ik~ o~n
now be detected by simple thresh~ld detectio~.
Timer
In the present example, ~ timer that ~tart~ at heel-~trike
and time~ out a~ter a time that corresponds to the duration
o~ the stance ph~se h~ been emplo~ed. In this way the
inform~tio~ obtained when She heel hits ~he floor has been
used. The timer control~ a tranæistor that rwitches the
st~mul~tor on and off (whi~h iB a commercially available
20 unit). The stimulator is turned on when the timer ru~s out
(estimat~d time of foot lift~ ~nd off when the heel hits the
floor Iwhich then initiate~ a new c~cle). The timer i~ :
adjus~able up to 2.7 ~. This system might ~e modified to use
the inormation obtained when the heel i8 lifted fxo~ the
floor.
T~e analo~ c~rcu~t described abo~e i~ ba~ed on a digital
implement~tion, uising al di~ital 6ignal proces60r tDSP) (TMS
320C35) placed on a plug-in ~rd in a I~M-~ompa~i~le peF~-ona
compute~ The sircuit wa~ thus implemented as a~ ~nalog
30 circui~ as at tha~ time it di~ not seem practi~ally possible ::~
to make a ~m~ll DSP ~ard ~or a porta~le ~nit. It i~
contempl~ted, however, that in the near ~uture it will be
18~37~iEII.001/AS/1493Q~; 04
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2 ~ 7
pos~ible ~o ad~pt a~ existing portable DSP æ~tem that will
be able to perform t~e same function and other functlon~
well.
The circuit presen~ed ~n Fi~ure lC is implemented using ~tan-
dard analog componentS. However, the size can be dra~t~cally
reduced by using 6urface mou~ted componentS (SMD), as the
present inventor~ have done with the amplifiers th~t have
been ~onstruc~ed. Furthermore, there seem to ~e no m~jo~
problems in implementin~ a digital version on a custom-
desi~ned chip (ASIC) that would include bo~h the ampli~ler~or t~e neural ~i~nal~, the electronics ~escribe~ here for
control of a s~imulator, and th~ s~imulator itself. This ha~
been done by others for more 8~ mple stimulators (~ee e.g.
~gnes and Creery), which has made it po~ible to mount all
the Compo~e~ts inside a biocompati~le case and im~lant thiS
in the body. ~ .
In ~ummary, ~o remove the ar~i~act~ described above, t~e
recti~ied ~ignal i~ thu~ bin-integrated in su~h a w~y th~t : ~:
the noise-free signal in-betwee~ stimuli i8 integrat~d into a
~in~le value by means of a ~witched integrator and
sample-and-hold circuit con~rolled by the ~timulation or
alte~native an~log or digital methods a~ described above.
Co~a~ina~io~ by s~imulation axti~acts wa~ ~educed by
~ampling the ENG only durin~ periods in-bet~een artifacts.
The resul~lng 3ignal, w~ich correspo~d~ to the smoot~ed
en~elope v~ She nerve signal, or in oSher words, the o~erall
a~tivity in the ner~e is then processe~ (~OGIC), after which
it can be used as a feedback ~iqn~l for the ~timul~tor :
~STIM).
Anoth~r method f~r suppre~sion o~ a stimulation artif~ct
could be to blank i~ out by ~i~her di~onneoting or shor~-
cir~uiting the recording electrode during and for ~ome time
after the sti~ulu~ pxi~ciple thi~ would wo~k if ~oi~ele~s
~witches we~e available. Howe~ex, ln e~perime~ts pe~foxmed by
the present inventors with currently a~ailable switches,
1~376~.~SIASI~3~
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lZ 2 ~ 5 7
these proved to be una~ceptable becaus~ o~ ad~itional
switching no~e. The metho~ of the invention only ~equires
tha~ the ~irst stage of amplification has a short
recovery-ti~e a~ter eYe~tual SatUration. It ia con~empl~ted
tha~ a recovexy-time in the range o~ 0-~ m~ will ~e
pre~erred, ~ut reco~e~y-times up to about 5-7 ms or even more
will be acc~pt~ble - depending on the ~equency o~ ~u~cle
stimulation.
Due to ~he larger distanceY that can be obtained between
stimu~ation electrode~ and a nerve cuff electrode it can be
expected that in human FES systems, th~ arti~act problem~ ma~
be smaller than thoYe presented i~ the cat model ~see Example
1~. On the other hand, human muscles can ~e larger than ca~
muscle6, and the numb~r of mu~cle~ ~i~ulated in a F~S system
o~ the invention may be much larger than fou~, which may in-
crease the number of artifacts. Ho~ever, as long as there i
at least 10 ~ between any two ~timuli, it should be posstble
to ~ample noise-free ENG. This ca~ be obtained if group~ of
~us~les axe stimulated ~i~ulta~eou~ly rather than ~n a random
or time-distributed manner. In hu~n applications, it i~ also
likely that the stimulation frequency will be lower than the
25 Hz per muscle uYed fo~ the cat expe~iment~, thereby
leaving longer artifact-free periocls between the consee~tive
~timuli.
25 Among several restorative application~ that can be envi~ion- :
ed, ~wo, in par~ r, ~o~ld in prin~iple be implemented
readily~ con~rol of ha~d fun~ion i~ ~uadriple~ic or hemi-
plegic per~on~, and control o~ stance and g~it in paraplegic
or hemiple~i~ pe~on3.
Elec~rical 6timulation of the pe~oneal ner~e, used for cor-
reGtion o a drop-~oo~ ha~ ~ecome an ~ bli~hed therapeutic -~
a~d fu~tion~l method. The ~timulation i6 applied during the
swing ph~se of the ~ffected leg and prevent~ drop-~oot, so
the patient walks faster and more securel~ The use of the
~5 natural tactile inform~tion recorded f~o~ ner~e~ suppl~ing
~ fi~ A~1~3~
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13 2~7~7
the foo~ can make it po~sib~e for ~he pa~ient to walk without
wires running from an exte~nal heel cont~ct sen~or to the
stimul~tor. using the distin~t peak th~t appear~ i~ the sur
ENG ~i~nal at heel - contact and the method of the invention,
it h~ ~e~n possible to cont~ol a drop-foot ~timulator dur~g
w~lking (see Ex~mple 2). The di~in~ neural peaks are
contemplated to relate to p~essure changes on the skin and
a~sociated stre~che~ of the ~kin mechanorece~o~ in the ~kin
area ~hat ~ innerv~ted by the ~ural ~erve.
10 The hum~n fingertip has ~ great capabi~ity to detect slips
between an objeat a~d the surface of the skin. ~urface fea-
ture~ protruding a few micrometers from the 3ur~Ace of an
object can be di~criminated whe~ ~troked alon~ the surfa~e of
the skin a~d small sli~s invol~i~g onl~ ~ p~rt of the ~kin :~
surface in contact with ~n object held in a precision grip
can be d~tected ~Johansson and We~tling, 1~87). T~i~
capabili~y ori~inate~ from the large number of low threshold
mechanore~eptors in the ~kin of the fingertips (as many a~
241 units/cm2 (Johansson and Vallbo, 1979)). The infGrmation
~rom these receptors is importa~t for the control of
preci6ion grip; if the ~kln i~ anae~thetized, the ~b~e~t
be~ome~ ina~pable o~ ~dequately adjus~ing the grip ~orce to
the weight ~nd surface structure o~ an objec~ (Joh~n~on ~nd
Westling, 1984).
During p~ecision ~asks, normal subjects u~ually produ~ g~ip
force~ ~re~y greater than the minimum force required to hold
a~ objec~ (Johans~on and Westlin~ 87), which is determ~ned
by both the weight of the object and the fric~ional prop-
er~ies of the sur~ace in cont~ct with the f inger8. If the
~0 grip force is insufficient and thQ object ~tarts to 81ip,
mo~t low-~hre~hold merchanorecep~ive ~ni~ re~pond with ~harp
bursts of ~cti~it~. Slips may happen if the grip force
ch~nge~; a~ ~ oonseqlle~e of ~h~ngin~ joint angles or f~ti~e,
if the weigh~ of ~he object increases (e.g. a coffee c~p ~hat
gets filled) or if the frictional coefficient decreases (e.g.
caused by per6piration). In normal human subjects it has been
18:Z376i31.0011AS/19~3~
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14 ~978~7
shown that a ahort-latency spinal reflex of cutaneou6 oxigin
is usually elicited by ~uch a ælip, ~o that withln 80 ms of
the ~tart o~ a slip, th~ grip force increases and the objec~
is held set;:urely again (,Johansson and Westl:Lng, 1987). This
rapid corr~ctive re~pon~e iS automatic, ~nd doe~ not i~olve
conscious particip~tion by th~ 8u~j ect~. The re~lex ~ction i~
quite powerful, to the extent tha~ sub; ects often cann~t
voluntarily relea~e their grip slowl~ ~o let an ob~ect fall,
be~ause the reflex tends to interfere ~ohans~o~ a~d
Westling, 1~87).
The cumulatlve activi~y of cutaneous merchanoreceptor~ can bç
reco~ded with a nerve cuff electrode (reviewed by Hoffer,
lggO) and is pre~umed ~o be adeguate ~or feedback control of
a sy~tem for ~un~tional electri~al ~timul~tion (~ES). The
relation ~etween the electroneurogram (ENG) o~tained from a
nerve cuff implanted on a sen~ory ner~e and the ~orce applied
perpendicularly on the sk~n innervated by the ner~ wa~
identified, but contained ~ome inherent ~on-li~earities tha~
made it difficult to use the EN~ for estimation o the
~0 perpendicular skin contact force. The sen~i~ivity of t~e
cutaneou~ mechanoreceptorQ to ~lip~ occur~i~g betwee~ the
skin and an ob~ect ~uggests that the ENG may contain a
different, and possibly ~rery u~eful, kind of infor~nation
other that ju~t information about per~endi~ula~ co~tact
force. The possibility o~ e~tracting 81ip ~elated information
from the ENG recorded with a ~erve cu~f electro~e and its
pos~ible applica~ion in an FES system for hand grasp is a
central feature of the present invention. Wi~h rellable Qllp
in~ormation available, an FES 8y~tem impleme~ting ~
r~ iGial gxipping re~lex~ should enable a par~lysed ha~d
to hold an obje~t with onl~r the neces~ary force and maintain
a good grip ev~n if the muscle~; fatigue, if skin~to-object
~iction ~ ges o~ i~ the weight of ~he obj e~t c:h~n~es . A
di~erent version of a~ H~r~i~icial gripping re~lex" ha3
prevlou~ly been imple~ented ~or the control o~ prosthetic
hand6, where the incipient slip o~ an ob; ec~ bei~ held by ~n
',:, - ~' ~ ` i
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~7~
amputee in a pro~thetic hand wa~ measured and u6ed to c~ntrol
the force o~ prehension (Colman and Salisbur~, 1967).
Ou~ e~perimental m~del of a h~nd ~aspang and lifting an
object was the foot of an an~es~hetized cat pressin~ ag~inst
5 an objec~ that would slide down if the force exerted by ~he
~oot was in~u~icien~ to hold the object in place. The fox~e
wa~ p~od~ced ~y stimulation of the plantar~lexor muscle~ vi~
intramuscular electrodes, u~ing a c~mputer controlled FES
s~tem. Slip i~formation extracted fxom ~he tibial ENG wa~
u3ed to compensate for slip occurring in two d~ff~ren~
experimental situations: When mu~cle ac~ivatlon declane~ a~d
the grip force ~ell below ~he minimu~ level re~uired for a
secure grip or when the weight of th~ object increased
suddenly while being held with a constant grip force, ~au8ing
15 the obj ect to move .
The findings made in connection wit~ these experimen~s gave
rise to another important main aspect o~ the prese~t
inventlon. This a~pect of the ~nve~tlon relates to a met~od
~or pro~iding a sec~e ~rip of an objec~ through FES o~ a
partially or completely paralyzed muscle which is involved in
holdin~ the obj ect, compri~ing
implanting a nerve electrode ~or ~e~n~ing electrical signals
~rom a sensory nerve which innerYates a part o~ the bod~
which i~ phy~iologically related to the partially or
completely paraly~d m~Rcle,
detec~ing the s~art of a slip o~ the obje~t from the ENG
si~nal from the nerve electrode,
and immediately upon detection of ~he ~tar~ o~ a slip
producing or modifying a control signal for activating a
muscle ~timulator and ~timulating the paralyæed mu~cle in
respons~ to gai~ control ~ignal.

:
16 ~9~7
~he ~tart o~ the slip ma~r, e . g ., be caused by an ex~xnal
change in the load or wei~ht o~ the object, or ~y an in~ernal
d~sturba~ce such as fa~ , or it may be c~used ~y ~ chans~e
in the frictional coefficien~ of the ~kin, such a~ due to
sweating.
As will ~e expl~ined in greater detail in the following, the
start o~ the slip is pre~erably detected ~utomatically a~ an
event that exceeds a predetermined threshold value, A
6uitable way of doin~ t~ig is whe~e the ENG recorded from the
sensory nerve is processed u~ing analog or digital circuitry,
arld a ~ilte~ed version of the ENG is subtr~cted from the
actu~l electri~al ~ignal sen6ed, thereby removing unrelated
background a~ti~ity ~rom ~he signal, the res~lting ~lcu~ted
signal being ident~fied ~s a signal related to the start of a
slip if it exceeds a predetermined ~alue. The fi~tered
version of the ENG, ~uch as a low pa~s-filtered ~ersio~, is
suitably delayed by a number of samples and then subtracted
from the act~al ~ignal ~en6ed. The actual signal which may or
20 may not represe~t a "start of sl~p-related signal", ~
suitably ~n unfilte~d ~ignal or ~ ~ignal which has been :
subjected to filtering wlth a shorter time constant than the
first-mentioned filtered ver~ion.
Fur~her de~ails concerning thi~ aspect of the invention are
given in below:
Sig~als from cutaneou~ mechanorec~ptor~ were recorded with a
nerv~ cuff electrode implanted on the tibial nerve of cats.
The~e ~lgnals ~an be rel2ted to the perpe~dicular ski~
co~tact ~orce appl~ed on the central footpad. The sig~al~ can
also be recorded during functional electrical stimulation
~ES) and th2ref~re may be u~ed a~ ~eedback ~or an FES s~stem
appropriate for restoring motor ~unctions ln patient6
paraly~ed ~y, for example, a ~pinal cord injury or ~troke.
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17 2~97~7
Example ~ describes how slip-related information wa~ derived
from the cu~aneous electroneurogram (EN¢). This inormation
was used in ~n ~vent-driven contxoller ~or pre~ision grip
that allowed the FES system to compensate ~or unexpected
5 61ips between an object and the skin. In thi~ way an "a~ti~i-
cial gripping reflex~ was implemented that comp~nsated auto-
matlcally for internal change~ tigue) and external pertur-
ba~ion~ lincreased load, changing frlctlonal coefficient).
Thls control acheme proved to be ~o~ust, and is presumed to
be applicable ~or restoration of precision grip in paraly~ed
humanfi using FES.
The info~mation recorded with a nerve cuff elec~rode
implan~ed on a cutaneous nexve can be used reliably for
~eedba~ ~o~t~ol i~ a ~ES sy~tem. This appro~ch could havP
dlrect applications for the restora~ion of preci~ion gr~p ln
spinal cord inju~ed patient~ (e.g. C4-C6 ~uadriple~ic;, where
i~ could ~e u~ed ~o i~plement a~ "artific~al gripping ~eflex'
zimilar to the natural ~ripping re~lex that 1~ prese~t 1
normal h~man~.
The ~ em of the invention reliably detected slips from the
re~orded ENG, in ~ituations where t~he slips occurred either
because of decreasi~g ~rip force or be~au~e in increased load
force. The grip wa~ ~ully regained by i~suing a pul~e doublet
to each of the four muscle~, combined with a 25-30% increase
in ~he duration o~ ~ubsequent pul~es. The reaulting grip
~orce clo~ely re~embled th~t o ~u~ane when ad~usting to a
~udder~ increa~e i~ load force (~oh~nsson and Westling, 198~)
by increasing rapidly to a high value and the ~et~lin~ at a
value ~omewh~t high than b~fore the load ~hange. ~he time
30 ~etween the obje~t fir~t started to move and ~lip detection
was in ~he range o~ 50 to 100 m~. Typically, for ~lip8 cauaed
by ou~ "fatigue" p~r~digm, the object moved less than 3 mm
before it w~ c~ught, and for ~lips caused by a ~udden
increase in load the object moved lesa than 4 mm befoxe it
W~S c~ugh~. The method proved ~o be equally robust in ~11
three c~t~ u~ed in thi~ ~tudy.
. _ . . .. . .
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` 18 2~7~7
Only one pa~a~eter (the threshold v~lue) i~ the slip det~c-
tion algorithm needed initial adjustment at ~ach da~ o~
experiment, although it did ~ot need any ~urther change~ for
~he ~st bf the recording ~e~qion (that usually l~ted 4-6
hour~ he threshold ~a~eter could be increas~d ~y more
t~an 50~ of its optimal value wi~hout ~eriously effecti~g the
detection of 81ips. Once ~et, the thre~hold value ~eeded no
other ~d~ustment durlng the re~t of th~ experimen~ that day.
The increme~t in the ~timulat~on intensi~y after ~lip w~s set
to 25-30~ in the pres~nt experiment~, whic~ proved necessary
and sufficient to ~ecure the ~rip i~ these specific ~itu-
ations. In a clinical FES system, the optimal value of thi~
factor will depend not only on the inst~ntaneou~ recruitment
curre for the stimula~ed muscle~s), but also on the rea~ons
15 for ~lips, e.g~ how the weight of the obje~t ha~ changed, how ~ :
strong a per~urbation was, as well as a number of other
factors, æuch as the frayility of the object. It is antici-
pated that this value ma~ be easil~ ad~ustable by the usex,
to ~it the exact condi~lons of his/her muscles, ~emperament,
and FES system.
In additio~ to e~abli~g an FES sy~tem to compensate for
declining grip for~e or external perturbations, slip informa-
tion may also be used for an initial determination of the
optimal sti~ulation i~tensity, and thus a~oid causing muscle
fatigue ~rom using unnece~sarily strong stimulation. The
sti~ulatio~ ~chem~ shown in Fig. ~, i.e., a ~lowly decreasing
intensity co~bi~ed with slip detec~ion and compensation,
~toma~ic~lly determine~ ~he minim~m ne~ess~xy intensit~ ~o
hold an object and to adjust to Qlowly varying load change6,
~0 or i~ may just be used initially to de~ermine a suitable
in~en~ity that i~ ~hen held constant unl~s and unti~ other
~ occur.
In the intact human, infoxmatio~ from ski~ re~eptors is
es~ential for the regula~ion of force duri~g p~e~isio~ grip.
Visual cues s~ch as ~ize, material a~d surface structure play
: . . . ' ' " ' ' ' . . . ;, ., ' ,, ' ' `: ~ ,
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~ 19 2~7~
a role in deciding the ini~ial f~rce~ when gripping and
lifting an object, but for the s~eady-state holding pha~e,
the ~oma~o~e~ory i~o~matio~ ~rom the skin effectively
defines the necessary force wi~h no app~rent relation to pre-
lift visual cues. The ra~ult~ repo~ted hexe suggest that an
FES system for precision grip in paralysed human~ could u6e
the same cutaneous afferent in~ormation a~ the intact
organism ~nd implement a slmilar ~ontrol strategy, thereby
adj4sting the ~rip for~e automatically to the weight and
surface ~tru~ture of ~he objeGt in hand in the form of an
"ar~ificial gripping ref l~x " .
In paraly~ed humans, tactile information ari~ing from the
th~mb, index and~or middle fingers could be recorded with
nerve cuff electrodes, either from the palmar ~taneous
branch of t~e med~an nerve p~o~imal to the wri~t, or from
individual internal digital nerve branches in the hand.
Experimen~s with a nerve cu~f implanted on the median ner~e
of a monkey (Milner et al., 1~1) have produced ~G -~ignal~
d~ring perturbation~ of p~ecision grip that closely re~bmble
~0 those repre~ented in the cat experiment~ by the pre~ent
inventor6 sug~esting that the median nerve may be a ~uitable
~ource of the de~ired signal.
~or the restoration of gait and ~tance 1n per~o~ i~paired by
paraplegia or ~troke, cutaneou~ feedback information
2~ originating from mechanoreceptor~ in th2 601e~ of the fe~t
could be recorded with nerve cuff electrodes implanted on the
internal and external plantar branche~ of the po~te~ior
ti~ial nerve, and the ~ural ~e~ve. The ~ibial nerve branches
contain afferent~ ~xom the medial and lateral aspects of the
30 ball of the foot, ~nd the su~l nerve contain3 affexent~ fro~
the ~eel. To avoid me~hanical damage to the ner~es or cuff
electrodes, the ele~trodes wo~ld ~e~t he installed proximal
to the ankle, rather than in the foot.
I~ st~oke patients who ma~ require o~ly electricsl ~timula-
kion o~ ~he pe~oneal nerve to control ankle dorsiflexion

209~ 7
during t~e ~wing phas~, a ~i~gle ~ural or tibial nerve cuff
w~uld ba ~uf~icient to monitor whether or not the ~ected
~oot i5 ~upporting wel~ht. Recording~ frvm the sural nerve in
man (Slnk~2r et al., 1991) hae demon trated a di~tlnct peak
in ~he nerve ~ignal at ~oot contact. In paxtially or oo~pl~t~
par~lçgi~ ~atients, wher~ the coordlnated activation o~ both
legs must be re6tored, three cuf~ recording electrodes in
each leg would provide in~orm~tion on mediolateral and
anteropo~ter~or welgh~ di~tri~ution on each leg, as well a~
on timing of foot contact and inter-limb load dl~txibution,
con~idered e~ential for ~u~cessful restora~lon o~ g~it with
~ES. although ~u~h lnformation ~an be obtained with external
preQsure sensor~ placed inside shoes, inherent problem~ of
calibration, ~echanical and electrical dri~t, lead breakage,
and ~en~itivity to en~ironmental factors like moiature and
temperature, th~t afect external tr~n~ducers, would be
avoided i~ nerve c~$f electr4des were used. Becau~e sati~-
~actory re~toration of gait often cannot b~ achieved u~ing
F~S alone, individual ~ol~t~on~ ~re likely to involve F~S-
ba~ed hybrid sy6tem~ tailored to the epecific pattern of~e~60rimotor def~c~t pre~ented by each patient.
For hand control application~, the tactile feedback recorded
~rom the median nerve or from ~ts ~ranche8 would regulate the
~utput of a portable mulsi~hannel FES ~ystem to control
~e~eral type~ o~ grip by stimulating for~arm and hand muscles
via, e.~., permanently lmplanted ep~my~ial electrode~. To
a~old ri3ks associated wi~h tran~out~neou~ pa~sage of lead~,
it would be pref~rabl~ that both the nerve ~ecoxding and the
musclQ etimulation information would be telemetered acros~
the ~kin. The command ~ignal~ for the FES ~y~tem would be
generated by the user, u~ing unaffected motor functionc. In
initial application~, regu~atory feedback would be
lmplemen~ed to uae slip ln o~mation to automatlcally update
the ~timulation parameter~. To also implement continuou~
~5 regulatory feedback, app~opriate algorithm~ would have to be
avallable to extract momen~-to-moment informa~ion on grip
force or other xele~ant p~rameter, fro~ the ~NG ~ignal.
1~2376BI.~OIIAS119~306 0~

~` 21 2097~7
The principle of the present lnvention may also be useful in
other ~pplications where physiologic~l sig~ls must ~e
sampled during stimulation o~ nearb~ muscles, e.~. in FES
systems USiXl~ the EMG from int~ct or partially int~ct muscle~
or ENG from e~i~ere~t nerves a~ a means to ~o~trol the stimu-
~ator or prothesis.
It i~ evident that ~he two abo~e main aspec~s o~i the
i~vention can be used independently or combined in o~der to
impro~e FES methods.
': ' ` ': '~ ':, :', : .: ` , ' ' , . : ~: ,

2~ 2~97~7
LEGEND ~O F~GURES:
Figure 1.
A) Principle for recordin~ a~d using natural sensory nerve
acti~ity from peripheral nerves in a sy~tem for functional
neuromu~cular stimulation. Figure shows as an example a
~ystem for restor~tion of upper limb fu~ction, but the
principle would be similar for lowe~ limb.
1. Telemetxic coupling between i~pl~nted and ex~ernal
equipment
10 ~. Implanted stimulator
3. Shoulder position ~enso~
4. Stimulation ele~txode~
5. External portable control units and batterie~
AMP: Amplifier for the ne~ral ~i~nal
15 ~BI; ~e~tifier ~ bin-integrator (see Figure lB)
~OGIC: Extr~ction of information and generation of control
signal
STIM: S~i~ula~or
~) Block dia~x~m o~ the artifact ~uppression technique and
met~od to co~t~ol a foo~drop stimu]Lator. The fir~t par~, tha~
corresponds to the RBI unit in ~i~ure lA, i~ where ~he
axtifact~ in the neural signal are ~uppressed. It consists of
the highpass fil~er, rectifier ~nd bin-integrator ~see text
for de~ail6). The second par~ peci~ic to the ~oot-dro~
prosthe~is application, and gene~ates a control signal for
the stimula~or based on the artifa~t free ne~ve ~ign~l. Thi6
~-- part corrsponds to the LOGI~ uni~ in Figure lA, ~nd con~ist~
o~ the band-pass ilter, rectifier, comparator and timer ~see
text for det~il~).
C) ~xample of how the ~y~tem in Fig~re lB can be implemanted
using standard analog elec~ronics. The p~rt~ separated ~y
d~shed lines corr~pond to the blocks in Figure lB. The
: ~ . :, ;;, . .
. .

23 2~97~
circuit here has bee~ used in a port~ble ~tem ~or footdrop
correction. See text for detailed description of the circuit.
Figure Z.
R~w ~i~nal recorded ~xom the ~ibial nerve cuff while nearby
~uscle~ were ti~ulat~d. Four sweeps o~ data are shown
~uperimposed. ~n the top trace, the b~ndwid~h was 65 Hz - 10
kHz, and the EM~ ~olleys were clearly present, wh~re~s in the
bot~om ~race, the signal was high-pass filtered at lOOo Ez
and the EMG pickup was pra~ti~lly removed. ~orizontal bar~
lo show the period~ duxi~g which the ner~e cuff signal w~s
bin-integrated ~d ~mpled by the computer.
AS - amplifier saturation
TO = Temporary tape o~erload due to saturation
Figure 3.
Veri~icatio~ of the a~ti~act removal method, The solid ~xa~es
~how ~he force (top3 and normal rectified, bin-integrat~d E~G
(bottom) during st~mulation of the four cal~ muscles in a cat
model under anaestesia. ~h~ da6hed traces ~how a similar
trial, with the tibial nerv~ blocked distal to the recordin~
cuff.
Figure 4.
~e~tified ~nd bin-inte~ted (RBI) hum~n ~ural ner~e cuf~
reco~ding~ while tapping with a finger on the ~kin within the
innervation area o~ the nerve. In the ~op trace, ~o elec- :
trical sti~lation is applied and the ner~e signal is no~
dis~urbed ~y artifactL~ ~hs middl~ trac~ shows the dist~r~ed ~ .
nerved signal when a 100 Hz stimulation is applied ne~t to
the nerve without ar~ifact suppre~sion. The bottom ~ra~e
shows ~he ~erve sig~l du~i~g e~e ~ame 100 Hz, but wlth
artifact suppression.
... .. .
' ' ' .~ , ' , . . ' .' ' ' ' ' ~ ' '
" ~ ~ " '. ' . ' ' I ~
~ '. ', . ~, , . ~ , ,

24 ~ 7 8 5 7
Figure 5.
Diagxam of elect~odes implanted in cat hindli~b and apparatu~
u~ed to measure ~eural respon~e~ during grip. The cat was
under anesthesi~. The limb was fixed at the ankle malleoli
and knee with atx~a~ic, cupped clamps. Forcas ~ere produced
by F~S via electrodes implanted in the ~our ankl~ dorsiflexor
~u~cles (MG, LG, Sol and Pl; not ~ re shown). ENG acti~ity
in the tibi~l ner~e was recorded wi~h a tripolar nerve cuff
electrode. ~hen the plantarflexor muscles were stimulated the
paw moved (curved arrow until the footp~d pressed against an
object ~hat could slide vertically along a low~riction
hearing. It wa~ covered with fine sandpaper o~ t~e s~rfa~e
contacted by t~e ca~'s footpad, and contained two ~orce
transducers to measuxe vertical (load) force a~d horizontol
(g~ip) f~rce, as well a~ a linear po~ition transducer to
measure vextical position.

`` 2s 2097~7
RE FEREN~ES
P.grles, W. F., MacCreery, r). E~., editor~, "Neural Prosthesis~
ln: dFundamerltal Studies~, Printice Hall, New ~er~ , USA,
l9gO .
CoL~a~. ~.B., I,l. Salisbur5r, A~ ol. Eng. S, pp~ SOS-~ll, 19~7.
tior~o~, A.~, }1, F~rssb~rg, R.S. Johansson, ~:;. ~cs~ Ylsul~ d~ cues ~ ~e progr~nF,
of ~an~p~lla~e fo~ces du~g prec~s~on ~p," ~p. Br~;n Rcs., 83, ~p. 477-482~ 1~91.
Haugl~nd, l~X., ~A. Hoffer, T. Sin~ "Ski~ contactforce i~f~a~o~ i~ elec~D~ ~aphic
sigr ~s ~:co~d by imp~ted ~lerve ~uff clec~dcs," JEEE rransaclzoAs on Biom~. En~.,
(sub~tted concu~ iiy).
Ra~glantl~ ~, J~. Hoffer, ~'Senso~y aervc s~nals ~ecorW by ~lg~nud cuff c~cctrodc~
duAslgfi~on~l e~ ic~l s~a~on of ~imb D:uscks,"lEEE ~oc~o ls on~iorr~d. ~ng.,
tsu~il~;a COD~n~ty),
~cr; JA., "TcchDiqucs to ~udy spinql-co~, p~ripheral n~. ~nd mu~cle activitS~ iA f~ely
m3~ ~a~s," NcuromcJfsod~, Yol. 15. pp. 6~ 1990.
J.A., ~u~land ~ ~nd Li, T~ Obta3~:ng skin ~ontact fos~e info~o~ ~m irt~plantcd
n~e cuff~ecording el~e~od~s, Pro~. IF~E L-ng. fn M~d, d~Biol. 30c, Inr~. ~or~ 928-
g~g, ~8~.
~o~e~, J~., Hau~ltnd~ ~ and Sin~, T. Fun~o~al resrora~on of ~ecision ~ip usl~ slip
~forma~n ob~ed f~ pesiphe~l ne~ve~eco~n~s. ~roc. Ann. ~ tl. Co~. IE~E Eng. in
~fcd ~ Biot. Soc. 13:~96-~g7, lg91.
Hoffer, ~A. and~laugland, M. Si~ls f~o~ tact;lg sens~rs in ~3abrous s}~n sl~itable for resPring :
motar f~ncdo~s in pa~alyzed human~ VRA~ ~RO~THESFS ~ Re,D~ b~g ~o~or
Fl~ncJion ~er Discose or ~ fsabil~ty, R.B. Stcin, ~EL Pe~ m ~d I~. Popov~c, edi~s. ~ :
Oxf~d U~i~. Psess, pp. 9~-12~, 1992.
Hof~cr, J.A., N. Sugano, (~.E. I,Deb, W.B. M~ks, hq.;l. O'I~ono~an, C.A. Pratt, "C~t ~indlimb
a~o20neumns dus;n~ 10con~ation. II. ~om~ tivîty pattent8t~ 30~ , of ~e~uop~ys. ~al, S7,
~o. 2, 3~p. 53~-553, ~eb. 1987.
. . ,
18~376131.M~/AS/19~3 ~
.: ~ : : . . : . ~ : : . , : . . . : .
:.: . . . :: : . , ,: ::
i . .: - ~: ~ I :: . . .

26 2~g78~7
Joh~ssDa, ~s., A~. 'It~o, "T~ sensibiliy i ~c human band: ~el~e a~d absol~
der~si~ies o~ pes ~f me~hano~ecep~e ur~iTs in gl~brous skin~"J. P~ ol. (Lond~ 2815,
pp. ~83-300, l9~g.
nsson, RS., G. Wes~ng, "~ s of ~labrous s~n ~eprors ~nd sensorlmolor ma~y in
au~oma~c c0~ f pr~isio~ ~p ~heJ~ ng rouE h~ ar n~ore slippay obje~ tas~
Res.~ 36, PF~ ~S0-5~4, lg84.
3Oha~s50n, ~.S., ~. ~es~ing, "Siga~ls in ~d~e ~ffere~ e fingers eliciPng ~p~l~e rno~
~sponses d~g pre~ grip," E;~p. Bra~ ~es, 6~. pp. 141~154, 1~87.
Joh~sso~. RS.. C;. Wes~ing, "Pn~gramm~d ~sd ~ggered ~e~n~ id loa~ ~ge8 d~ g
prcc~sic n ~ip," E~p. Br~in R~s., 71, pp. 7~-86, 1988.
l~ilncr, T~., C~ Dug~s, N. Pic8$d, A. SInltb "~usaneous ~ nt acti~ n the meti~n ~e . . .
dun~g ~aspnng in thcpr~a~c,~aln~cs., 548, pp. æ8 ~41, l~gl.
Si~ ugl~d, M., Haase, J. and ~of~e~, J.A. Whole senso~ ve re~s 1~ hu~
-~n app~icadon f~rne~al p~s~eses. P~oc. Ann. ~ntl. Co~ E; Eng. in ~ed. ~ Bisl. Soc.
900~ 91.
~P1lbO~ A.B., R~. Joha~s~on, '~p~es of sutancous ~cc~anor~ep~r~ he hu~Dan hand
rcla~ oucb sensa~on," H~n Ncuro~o~. 3~ 14, S~ger Verlag, l9~A
Wcs~ling, ~ RS. ~oh~sson, "Rcsponses in glabsous sldn mechanorec~s d~ p~slon
~p fn h~mans," E~p. br~in re~carch, N~. 66, pp. 128-140, 1987.
Zaj~c, E:~.. ~L. ~oung, '~schar~o prop~cs of hindlisllb moto~curons L~ d~brate ca~ during ~ ~ :
~ocomo~o~ ~nduced by mese~ceph2~ic s~mu~a~on", Jour~ of ~europhysiology, vol. 43, pp.
1221-1~35, May 1980~.
. . .
~, : , : ,~
;,: . . , : : . :

--` 2~8~
27
EXAMPLl~S
EXAMPLE 1
MINIMIZING ~ G~AR'rIFAt:~T SIGNAI GENERATEr) BY MUSC~E
~:TIMU~TION I~ A CAT E~CPERI?~ilT
5 ~_
In ~at~ which were surgic~lly ane~thetized, a 30-40 mm long,
2.2 mm I.~. silicone rubber cu~$ with 3 circumfer&ntial
~tainle~ steel wire electrodes (Cooner A~ 631) wa~ impla~ted
on t~e le~t ~ibial ne~v~, 2-4 cm proximal to the ankle joint.
A scia~ic ner~e recording cuff, 20 mm long, 4 mm I.D. with
three stainless steel wire electrodes, was implanted in the
mid-thigh region. Leads from the cuffs and other lmplanted
device~ coursed 0ubcu~aneou~1y to a~ external connector
mounted on the cat'~ back a~ described in ~offer, 1~0. A~ter
:L5 6urgery, catq were ~ive~ analgesics (Acepromazine Male~te ~nd
subcut~neous Morphine, 0.10 mg/kg) for at least ~4 hr.
Recording sessions ~tarted 4-7 day~ after implantation.
Nerve blocking cuffs:
To exclude the participation of motor activity in the ENG
~0 recorded from the tibial nerve during walkin~, in several
cats a blocking cuff 8 mm long, was placed on the tlbi~
nerve, b~tween the ti~ial and sciatic recording ~u~s. ~xonal
condu~tion w~ blocke~d by infusing lidocairle sodium solution
(~), via a catheter that 1~3d to the bloclcing cu:E:E from a :
25 ~ort in the external connector. The conduction block was :
asse~sed from the pr~gre~si~e reduction of the compound
action ~otential xecorded by the s~iatic ner~e cu~f, e~oked
by stimulation o~ the tibial ner~e at the distal r~cording
cu~. Usually, the tibial nerve was completely blocked after
30 20-30 mix~ute~. ~t ~che end o e~L~h expe~im~nt the block wa6
rever~ed wi~ usion of norma~ ~aline solution. . .
'. , . , ' : ': '. '.':'~ ~ ' "' i '. ' ~ " ' ::

2~ 2~97~7
~n o~hex cat3, a tibial nerve blocking cuff wa~ placed dis~al
to the tibial nerve re~ording ~uff in order to identify the
contributions fro~ footpad ~erents, and the pre~ence in the
recording cuff ~i~nal o~ any artifacts cau~ed by the ~timuli
s a~d/o~ compound EMG potent~al~ d~ri~g FES of nearby mu~sley.
ata ~ollection:
~ average once per week during a 1-3 mo~ths period, each cat
w~s anaesthetized with halothane g~s, the left ~oot wa~
shaved, remaining hair was removed with depilatoxy cream, ~nd
~he leg was s~cured at the ~nkle malleoli ~nd knee with two
pair~ of cup~ed holders. In the first series o~ experime~t~,
a servo-controlled motor wa~ u~ed ~o pu~h perpendicularly on
the ~entral footpad with ~ 1 cm di~c~6haped probe, ~pplied
fo~ces were monitored by a ~ries tran~du~ex, The ~osition
and compli~n~e of the motor were electronically re~ulated
with posi~ion, veloci~y and ~or~e f~edback. Control 8igna
were generated with ~n IBM-compatihle l386 computer. ~e
tibial E~G wa8 analog-rectified ancl bin-~ntegrated i~ 1-lo ms
bi~ ak PSI-l). ENG, m~tor position ~nd forc~ d~ta were ~:
digitized on-line (100 Hz/channel) with the same computer.
Removal o~ arti~c~
Two ~teps are used to reduçe the ~mplitude of arti~act~ from
near~ mus~le activity (EMG) in the nerve ~ctivity ~ENG
si~nal): 1) High-p~g~ filtering and 2) ~ynchronization of
6ampling and stimula~ion.
) The freq~ency di~t~ibution~ of ENG and EM~ re~orded by
tripolar nerve cuf~ electrodes are largely ~on-over-
lapping. Most o~ the E~G could th~r&~ore ~e ~extracted~
from the cuff signal by filtering the ~ignal w~th a ~harp
hiyh-pa66 analog filter at 1~00 ~z (Ithaco model 4302,
set at 80 ds/decad2).
~) Bec~use the times of 6timulation were k~ow~ a~d both the
~timulatlon artlfa~t a~d the EMG CAPs were limited in
8~376~ 1~306 P4

- 29 2~978~7
~ime, it was pc~6~ible to reduce th~ arti~ac~ pickup ~ub-
stantially ~ only u~lng the cuff ~i~nal at the end of
the inter-pul~e int~rval, i.e. the sa~pling wa5 locked to
the ~timula~lon, resulting in a ~ampling frequency of
loo Hz.
Figure 2 ~hows 4 superimposed recording~ o~ the cuff signal
durlng FES. Each record wa~ 40 m~ long and thus included 4
~timuli. The four tra~es were ~yn~hronized to the time ~f
stimulation of the soleus muscle. Each tim~ a muscle was
stimul~ted ~abelled 'Stiml), the fi~t event in the ~uff
signal w~ the ~timulation axtifact, ~howing up ~ a narrow
spike that would vary in ampl$tude depending on the
~timulation inten~ity and the ~uscle that wa~ ~timulated.
This was followed by the compound EMG volley fxom the
~timulated mu~cle, ~howing up a3 a ~lower, large ~mplitud0
wave in the cuff ~ignal (la~elled EIN). T~e shape of this ~MG
bur~t depended on the stimulus in~ensity and ~he mu~cle being
~timula~ed, but ~ otherwise very repeatable, The neural
~ignal itself wa~ the hi~er-frequency signal, 5 ~V in
amplitude, onto which the artif~ct~ wer~ ~dded.
Th~ data in Fi~ure ~ were obtai~ed by record$ng the cu~
signal on an FM ~ape re~order while~ the co~pute~ c~ntrolled
the stimulation intensity using external foxce feed~ack, as
de~cribed above. The signal was then replayed and ~ample~ at
a high rate t20 kHz) to produc~ the. ~igure. For large
po~itive arti~act amplitude~, the amplifter satuxated (marked
AS) and for la~e ~egative amplltudes, the t~pe record~r
overloaded (marked TO) ca~ g th~ nal to be zero during
the overload.
The effecti~ of filteri~g ~an be seen by comparing tihe top a~d
bottom tra~es in Figure 2. In the top panel, filtered b~tween
~5 ~z and ~O k~z, the pickup of the EMG volley ~howed up very
clearly. In the hottom panel, the same ~ignal wa~ ur~her
high-pa~ filtered at 1 kHz, and the EM~ çontamination wa~
3S laryely removed.
I~37~x.~ ~306~

2~78~7
The ~timul~tion artifacts were bla~ed out by sampling the
BNG ~nl~ durin~ period~ _ -between artifact~. Periods of
artifacts are normally e~ily located by visuel inspection of
he ~NG-signal since remain~ o~ stimulus-related EMG, direct
stimula~io~ ar~i~act~ and amplifi~r r~covery are ~ynchronized
~o the stimul~tion, which i8 no~ ~e case for the ENG. ~he
bin was defined so that none o~ the~e ~rti~act~ we~e apparent
within the window. Instead, we used a re~ti~ier/integra~or
(B~k RBI-l) that had an adjustable inte~r~tion period a~d was
reset in synchrony wi~h an external clock. Thi~ clock was
supplied by the ~tlmulator, and it was thus pos~ible to
integrate the E~G signal in bin~ that las~ed 3-4 ~ and that
included only data from the la~t pa~ of each inter-stimulus
interval (~o~izontal bars in Figure 2~. The ENG in eac~ o~
15 the~e periods was ~ectified an~ in~egrated, resulting in a
sin~le value ~or each bin that was sampled just before a new
stimulation pulse was elicited.
The ~alidlty of thi~ method of noise or artifa~ suppre~sion
WAS demonstrated by the ~ollowing ~xperiment. ~he muscle~
20 were first stimulated to generate a force profile show~ by
the ~olid trace in Fig~re 3, top panel. Thi6 gavç rise to the
~NG signal shown by the ~olid trac~3 in Pigure 3, bo~tom
panel. Wi~hout changing the setup, conduction in the ne~ve
was th~n blocked with infusion of 0.4 ml lidocaine to the
blocking cuff. A~ter approximately half an hour, the ENG
~ignal recorded from ~he tibi~l nerve was insensitive to
touching a~d squeezing o the ~oot, demonstrati~g that
afferent conduction wa~ completely blo~ked. The -~timulation
was then repeated and a similar force profile was generated,
(shown by the dashed line in Figure 3, top pan~l). The
sampled cuf f ~ignal was ~ow redu~ed to the ~lat dashed line
in ~igure 3, bottom p~nel, i.e. containing ~either E~G, nor
s~imulation artifacts or EMG. Since ~he only difference w~s
the blocking o~ the ~ex~e distal to the reco~ding cu~f, thi~
experiment showed that for the unblocked ner~e, the sampling
method removed all introduGed artifacts and only ~ampled ENG
~c~i~it~.
IU376EX.0011AS1199306 04

31 2~78~7
EXAMPLE ~
FOOTDROP PROSTHESI~ ~N A H~MIP~E~IC SPASTIC MALE
For the footdrop prosthe~i~, the neural ~ignal from the sural
nerve can be u~ed ~or detection of foot-contact.
S Hi~hpa~s-filtering at 1 Hz followed by rectiEicat~on and
threshold ~omparison reliably detects when ~he hebl touche~
the floor during walking. Thi~ h~s been u~ed ~o ~witch on and
off a commercially available peroneal stimulato~ lKDC 200~A)
a~d in ~his way, replaci~g the usual heel-switch ~at mu~t be
mounted in the shoe with the ~atural sensors in the 6kin of
the ~oot.
In the present example, the sural nerve in a 35 year old
hemiple~ic ~pastic male subject with a drop foo~ was
instrumentecl with a ~ripolar whole nerve cuff electrode
15 approximately 7 cm proximal and 3 cm pos~erior of the ~atsral
malleolus of the right ank~e joint. A cli~ical examination
had xevealed tha~ the ~atient had an Achille~ tendon con-
tracture and tremor ~round the ankle j oint. ~he subject gave
his con~ent and the ~tudy wan approved by the Local Ethioal
Committee.
Surgical procedure
The surgery was performe~ during lo~al ~naesthesia. To
pre~ent compres~ion-neuropathy a~oci~t~d wlth post-surg~cal
oedema, it was ensured that the inner dlameter o~ the cuff ~.
wa~ more tha~ 3~ la~ger ~han the ner~e diame~ex. The th~ee
Teflon-coated multi~t~nd ~tainless steel l~ad out wixes
~ooner Wire Company, ~5A) from the ~uff elec~rode we~e put
through ~he skin approxir~a~ely 25 ~m abo~re ~he la~eral
malleolu~3, The rlerve cu~ was placed so that the nerre was
30 neither pulled xlor tor~ed by 'che wires. Thls make~ the
long-tenn prognosis of a nerve prepa~a'cion excellent.
ls237~;~lAsll~3o6 o~

32 2~7~S7
Nerve cuff electrode confiquration
The nerve cuff recording ~lectrode consisted o~ an insulating
cuff (silioone tubing) cont~ining thr~e circumferential metal
electrodey (~lexible 40-str~nd stainle~s ~teel wir~, ~e~lon-
co~ted~, placed around pa~t of the sural nerve. The de~ign,fabxica~ion and surgical implan~atlon of nerve cuff r~cording
electrodes have been reviewed in detail elsewhere (~o~er,
lg90). The in~ulating cuff ~erve6 to re~ol~e the sm~ll act1on
currents gener~ted by nerve fibres, by constraining the
current ~low within a long, narrow resi~ti~e path. In this
applic~tion, the ~uff wa~ 3 cm lon~ ~nd had an inner di~met~r
of 2.5 mm.
eural ~e~ g~Sion_and s~imulation
The leads ~rom the implanted nerve cuff electrode ~ere con-
nected to a dif~erential ENG ampli~ier with a high common
mode rejection. The ~r~n~cutaneous ~timulat~on was m~de by
means of a reference electrode abo~e the tibiali~ a~terior
muscle and an ac~lve ele~trode above ~he common perone~l
nerve just distal to th~ br~nching off of the ~uperficial
~O peroneal nerve.
The neural amplifierrwas ba~ery-~upplied a~d optlcally
isolated ~rom the mai~s ~o increase the common mode rejection
and to reduce the risk to the gubj~ct. To further reduce
noise pick-ups, an external ref~rence electrode wa~ placed
b~twee~ the stimulation elec~ode~ And the nerve ~uff
electxode. T~e ~eural signa~ wa~ fourth-order b~nd pass
filtered from 0.7 to 10 kH~ (Kron-Hite, model 3750). This
would red~ce remai~i~g pick-up of 50 Hz from the m~ins, if
any, and the EMG from ~eigh~ouring mus~les to a negligible
level. ~he bandwidth of th~ record~d neural ~ignal ran~ed
~ro~ 0.2 to 3.0 kHz.
1~376EX.WI/AS/1~306 W

`~ 33 2~97~7
and wlthou~ removal o~ arti~act~ ~xom_ ~he nerve ~iqnal
The ~ural nerve activit~ in a human Eubject was r~cord~d
while tapping with a ~inger on the skin w$thi~ the inner
vation ~rea o~ ~he nexve. Fig. 4 (top) ~hows the ampli~ed,
recti~ied and integ~ted (RBI) nerve si~nal without an
el~ctrical Qtimulation. A ~lear peak in the ~erve signal was
observed when the finger touched the skin. Fig. 4 (middle)
show~ the RBI sural nerve activity when an electric~l ~timu-
lation every lO ms (100 Hz) was applied ~ex~ to the nerve.
The electrical 6timulation eli~ited an a~tion pote~ial in .
the nerve r~cordings approximately 2 m~ after the st~mulation
~i~h a duratio~ of approximately 2 ms (not ~hown). Fig. 4
~middle) shows how thi~ unwa~ted ~ignal incr~ased the
xecorded activity making it ~ery difficult to detect thenerve re~pon~es caused by the finger-tapping. Applying the
~rtif~ct suppression techni~ue by samplin~ the nerve signal
in a window from 5 to 1~ ms after each stimulation, the art~-
facts ~ere removed and the ~erve ~esponses to the finger-
tapping were again reco~nized in the cuff electrode recor-
dings tfig. 4 (bottom)). The ~ecti~ied and integrated nerve
signal in each of the sampled periods after a stimulatio~
re~ulted in ~ single ~alue ~or each bin that was ~ampled ~us~
be~ore a new stimulation pul~e was elicited. The artifact ::
~5 suppression is made exactly as desGribed for the cat data in
Exampl~
BXANPLE 3
Slip-detection and ~ompensation in a eat model of human
position grip
The hindlimb of anaestheti~ed cat~ was used as an
experime~t~l ~odel for the paralysed human limb, with the
central footpad as a mod~1 gla~rou~ skin. Three cat6 (4-~ kg)
were chroni~lly implan~ed using asep~ic technig~es,
~ :
l R~37~ A~ g93 o6 o~l ~
' j : ' ' ' ' .................................... : ' '
' " . '~ ' ", ~ . , , ~ , , ' :

, ~4 2~7~7
~ollowing the procedure~ and guidelines described in ~xample
1.
Bipolar intramus~ular stimulation elec~rodes were im~lanted
in each o~ ~our ankle extensor muscles: Medi~l a~d lateral
ga~trocnemius (~G, LG), ~oleu6 (Sol~ an~ plant~ris (Pl). The
electrodes ~onsisted of two Teflon coated, 40-~tr~nd ~tain-
les~ ~teel wire~ (Cooner 634), with the e~d~ dein~ulated for
15 mm, and ~ere in~ert~d in the muscle diagon~lly to the
fibres, about 2 cm ~part in the proximal part of the muscle
(see Fig. 5). Bipolar ~timulati~n electrodes were used,
rather than monopolar with respect to a common ~ro~nd,
because of the higher 6electivity attained~
A tripolar nerve recording cu~ ~30 mm long, 2.2 mm I.D.) was
implanted on the tibial nerve, distal to the mu~cular
branches; and 4-5 ~m above the ankle. A~ this level, the
tibial nerve contains mainly Affere~t fibre~, mo~tly from the
plantar Yur~açe of the foot and the ~ootpads, and the cuff
could ~e implan~ed without obstxuc~ing the blood ~upply to
~he nerve or causing mechanical damage to t~e nerve.
The cats recovered for at least 3 days ater ~urgery ~efore
the first experiment was performed, in order for the
implanted devlce~ to sta~ilize wlthin the l~g. At the
begi~ning of each recording session, ~he cat was
a~ae~thetized with an intr~enous injection of Thiopentothal
(8-10 mg/kg) throu~h a catheter implanted in a superficial
jugular vein, intubated and maintained under anae~thesia with
Halothane in a mixture of nitrou~ o~ide and oxygen.
To remove sen~oxr affe~ent ~ontribution~ from hair receptors
in ~he skin surrounding the centxal footpad, prior to ea~h
experiment the ~oot was sha~ed ~nd treated with ~epila~ory
cream, followed by ~ thorough wash and application of
moisturizing cre~m.
Ig~376BX.WI/A~/19930C 04 ~

:
`` 35 2~3~7~7
During an experiment, the cat waE~ supported ~y a heated
sling, with the implanted hindlimb fixed by two pairs of
cupped claTnps pressed around ~he an1~le ~nd knee jOlnt8 (~ig.
5). This allowed the a~kle joint mo~re and did 3lot do ~erious
5 damage to the 3}cin. The ankle and knee angles were 100. The
foot huny Yertically w~exl ~o~ ~imulated. When the ankle
extensor mll~3cles were ~timulated, the ~ootpad p~l~hecl
horizontally again~t a ~e6t object that could s~ide
ve~tically with low fri~ion alo~ two bars, and that would
fall if held by ~he foot.
I~:? analogy to the precisios~ ~rip experimenta by Westling and
Johansson ~19~7), th~ o~ject w~s equi~ed with force aensor~
that mea~ured the horizontal grip force ~nd the vertical lo~d
~orce by means of strai~-gauge force transducers ~Revere,
FT50). T~e vertical position of the object wa~ measured with
a m~ch~nical linear po~ition transducer (W~ters, LRT-S-lOOB)
(Fig. 5). ~ravity caused a constan~ downwards pull of 1.4 ~,
since the object weighed abou~ 140 grams. The ~urface of the
obj ect was 600 grit sandpaper .
~0 The s~imulator we uaed for F~g ~as the same a~ in ~xample 1,
produced rectangular monopha~ic co:n~tant current pul8es with
a fl~ed ~mplitude for ea~h channel. Pulse widths were
independently controlled for each of the fo~r muacles between
û and 255 ~lS, in s~eps of l~s, by a '386 computer via a
parallel po~t. Each muacle was 6timulated at a fixed
frequenc~ o~ 25 Hz, i.e. with interpulae intervals of 40 ms.
To re~uce ~orce rip~le ~au8ed by unfused tetani, the four
muscles were ~timulated se~uentially, so that o~e of the
muscles wa~ ~timulated every lO ma, giving ~n ~ggr~gate
stimulation frequency of 1~ Hz, e.g. the ~me a~ de~cxibed
in E~ample l.
The ENG si~nal xecoxded from the tibial nerve was filtered :~
~lk-lo kHz bandpass), rec~ified ~nd bin-integrated (in one 3
ms bin every 10 ms) be~ore sampling. This procedure ~a~ used :~
3$ to cancel out the pickup o~ artifacts as de~cribed in Example
1~2376EX.0011AS/1~9~06 04
. :: ,: . ` . ` , : : .
~': ~ ~ : .' : , : ` :

~~` 36 2~7~
1, ~nd also allowed the u~e of a l~wer ~amplin~ fre~uenc~
(100 H ) that the ~requency necessary to sample the raw E~G
~20 kH~. The bin-integrator and sampling were ~ynchronized
to the delivery of stimulation pulses by the com~uter. In
khis way the EN~ envelope ~a~ ~mpled at the sa~e $requency
as th~ ~ggregate ~timulation rate (100 ~z). In the following
the term llE~Gll will ~efer to the envelope of the ENG rat~er
that to the raw ENG, since o~ly the envelope w~ ~pled ~or
feedback purpo~e~.
lo Resul t~
To investiga~e slip-related info~matio~ contained in ~he E~
~ign~l, the following initial experiments were done: The four
plantarflexvr mu~cles ~ere stimulated with a train of pul~e~
o~ constant width, thus generating a force that was
approximately const~nt. The pulse width wa~ chosen 80 that
the generated fo~ce was not suf~lcient for the foot to hold
the ob~ect in place. Uhder these condition~, the ob~ect had
to be partially ~upported by the e~perimenter, who ~ould thus
allow it to fall by relea~i~g it~ ~upport in ~m~ll 8teps,
each step cau~in~ a slip betwe~n the pa~ and the object as
de~cri~ed in Hof~er and Haugland ".~92.
The ~harp bursts of ~G activit~ that signalled when ~lip8
occurred were typical ~or all e~perime~ts and f~r all cat~
used in thi6 ~tudy. Slip-~el~ted burs~s were di ti~ct eno~gh
from the backgxound ENG to be detected wi~h great ~u~acy,
and very early in the sl~p phase.
The sharp bur~ts.o~ ~NG activit~ that ~ignalled when ~lips
occurred werf3 ~pical ~or all experime~t.q and for all cats
u~ed in this ~t~d~. Slip-relaSed burst~ we~e dl~in~ enoguh
30 from the ~ack~round E~ to be detected with great accuracy,
and very early in the slip phase.
lR~ nnllA~ nftn~ ~

37 2~97~57
A. Detect1on of sli~
Sinçe ~lip~ were accompanied by ENG bur~t~, they could be
detected comparing the di~eren~ial E~G to ~ th~eshold ~alue.
Simple dif~erentiation, through, calcula~ed a~ the dif~erence
~e~ween the present ~Ç v~l~e and an old ENG ~alue, pro~ed
too noi~y. In~tead~ a "slip detec~ion" ~ignal waa calculated
by subtrac~ing d lo~-pass ~iltered (time con~tant = 0. 28)
ve~ion of ~he F~NG ~l~nal dela~ed by 20 sample~ (20Q~) from
the ~unfilte~ed' E~G, thereby remo~ing the b~ckground
activity from the ENG. The 'unfiltexed~ ENG al~o needed some
~i~tering to reduce no~e, but thi~ was done with a ~orter
time con~tant (0. 07s). The set of time constant~, ~ela~ and
threshold value save the most sensitive and robu~t ~lip
detection were ~ou~d by trial and error.
Implementation of the d~tection algorithm wa~ done in C
(Tur~o-C 2.0, Borla~d), and the filt~rs were i~plemented a~
~irst order auto-regressi~e (AR) ilters, which are computa-
ti~nally ~ery ~imple. ~he algorithm to detect slip is show~
below:
repeat (this loop xu~ a~ 100 Hz)
Update 20 samples o~ old E~G v~l~e~ :
Sample new ENG v~lue
Background~G~BackgroundEN~*a+OldENG* (l.a~
SlipENG-SlipEN¢~b+NewENG*(1-b)
SlipDetect-Slip~NG-B~Ckgr~UndENG
if SlipDetect~Thxe~hold then ~iqnal that ~ ~lip o~curred
e~d
The constants a a~d b were de~ermined from the time constants
di~cussed abo~e (for O=~.2~ a=0.~51 and n,o . 07s--
~
~Y0.867). Within the al~o~thm, the mu~cle stimulation inten-
sitie6 were also determined and pulse~ were ~ ed by the
computer, as de~cribed below.
18Z376~X.~I/AS/19~306 04

38 2097~57
B. Increase of force after slip
A~ ~oon as a slip was detected, the fo~c:e was in~rea~ed as
fast as po~3ible to reesta~ ;h a secure grip of the object
hefore it moved out of reach. This was done by one of the
~ollowing two di~exen~ method~ By introduoing immediate-
ly a single, closely ~paced pair o~ stimula~ion ~ulses (~dou-
blet") to each of the four mu~cle~. ~his i~ a technique thatis also u~ed by the central nervous system i;n ~o~rnal çondi-
tion~ ~nd can cause t~e force to not only increa~e rapidly,
but al~o remain high for a prolonged period afte~ an extra
pul~e. The ~ime be~ween the two pul~e~ was set to 5 ms. 2).
By increasin~ the pulse width ~arkedly for a ~hort period
after the 61ip, in order to recrult ~o~e mo~or units~
Once the gr~p wa.s re-establishad, it w~s maintaimed by incre-
~ing the pul~e width moderately (rel~tive to the original
PW). ~i~h ~his approach, the grip force change~ cloaely
resembled those seen in hum~n~ d~rlng the ad~ustment to
~udden increases in load force (~ohansson and Westling,
1988).
Because the ENG was sampled at 100 H~, a maximum of 10 ms
could elapse b~tween ~he detec~ion of a slip ~om the ~NG and
the response from the controlle~. Since the ENG w~s ~a~pled
jwst before each stimulus pulse wa~ elicited, ~he fastest
response ~o a detected ~lip wa~ determined only by ~he time
it took to do the calculations (le3s th~n 1 ms). The main
delay in the ~lip detection was caused by the low-pass f il-
tering of the EN~ that wa~ necessary to remove ~alse detec-
tions caused by normal variations in the ENG. The time-con-
stant for thiæ ~ilte~ wa~ 70m~, as de~ribed a~ovQ. The delay
30 fxs~m ~he monl~nt the object first started to slide dow~ un~il
the ~lip w~ detected w~R betwee~ 50 to 100 ms, ~ut ~aried
considera~ly.
doublet pulse caused the next ENG sample to contain addi- -
tional stimulus artifact, but this wa~ not a problem, becau~e
t~2376~X,OOl/AS/19~3~ 04

` ~g 20978~7
once the controlle~ was switched i~to "~lip comperlsation
mode", it did no~ req~ire or expe~t ~lid ~ample~ fo~ the
ne~t 300 m~. Thls p~evented e~xoneo~ detec~ions o~ ~lip
during rapid in increase~ in stimulation intensity, which
predictably gave ri~e ~o ph~sic EN~ burst~ ~hat could
resemble t~o~e caused ~y a 81ip.
The stimulation ~lgorithm in~luded an ~utomatic ~hut-o~f o~
stimulation in the ob~ect dropped ou~ or rang~, determined by
monitoring the signal from the vertical position transducer.
lo C. Te~t o~ closed-l~oP_slip com~en~ation controller
Two set~ of expe~iments were done~
1) In experiments that ~ lated progressive "~atigue" in the
stimulaa~ed muscles, the stimulation ~tarted at ~ le~el higher
that the minimum nese~ y to hold the object. The inten~ity
of sti~lation was then decrea~ed at a constant ra~e, until
the ~or~e became in~ufficient to hold the object, whiah then
~t~rted to alip. De~ection of the ~lip triggered the control-
ler to lncrease the intensity and gra~p the object a~
detailed ln the preceding ~ectiOn, i.e~. an llartificial grip-
ping reflexll was ellcl~ed. ~he in~en~ty of ~timulation wa~~hen slowly decreased at the same rate as prior to khe slip.
2) In experime~t~ ~hat ~odeled the response to lncrea~es ln
external load, the st~mulation inte~sity was held constant at
a le~el ~ufficient for the foot to hold the object. After a
fi~ed time, an extra load wa~ dropped o~ the object, causing
the obiect to ~lip and start to ~11. The ~artificial reflex
loop" cau~ed th~ slip information obtained from the neur~l
~ign~l to increase the ~timulation inten-~ity and thu~ o
the ~rip foxce, in orde~ to ~atah the object before it fell~
1a~q7~1:Y nn~A~I1aoqn~n~
:,' ' . , , , ~ ~ , ,., ,,,: ''

Representative Drawing
A single figure which represents the drawing illustrating the invention.
Administrative Status

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Event History

Description Date
Inactive: Inventor deleted 2001-12-27
Inactive: Inventor deleted 2001-12-27
Inactive: Inventor deleted 2001-12-27
Application Not Reinstated by Deadline 1999-06-04
Time Limit for Reversal Expired 1999-06-04
Deemed Abandoned - Failure to Respond to Maintenance Fee Notice 1998-06-04
Application Published (Open to Public Inspection) 1994-12-05

Abandonment History

Abandonment Date Reason Reinstatement Date
1998-06-04
Owners on Record

Note: Records showing the ownership history in alphabetical order.

Current Owners on Record
MORTEN HAUGLAND
ANDY HOFFER
THOMAS SINKJAER
Past Owners on Record
None
Past Owners that do not appear in the "Owners on Record" listing will appear in other documentation within the application.
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Document
Description 
Date
(yyyy-mm-dd) 
Number of pages   Size of Image (KB) 
Drawings 1994-12-05 7 358
Claims 1994-12-05 4 210
Abstract 1994-12-05 1 72
Cover Page 1994-12-05 1 43
Descriptions 1994-12-05 39 2,427
Representative drawing 1998-08-11 1 15
Courtesy - Abandonment Letter (Maintenance Fee) 1998-07-02 1 189
Fees 1997-05-23 1 38
Fees 1996-05-29 1 36
Fees 1995-05-24 1 39
PCT Correspondence 1994-02-07 1 27
PCT Correspondence 1998-02-03 1 34
Courtesy - Office Letter 1998-03-11 2 40
Courtesy - Office Letter 1994-01-21 1 19
Courtesy - Office Letter 1994-04-08 1 16