CA2223682A1 - Apparatus and method for locating a nerve - Google Patents

Apparatus and method for locating a nerve Download PDF

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Publication number
CA2223682A1
CA2223682A1 CA002223682A CA2223682A CA2223682A1 CA 2223682 A1 CA2223682 A1 CA 2223682A1 CA 002223682 A CA002223682 A CA 002223682A CA 2223682 A CA2223682 A CA 2223682A CA 2223682 A1 CA2223682 A1 CA 2223682A1
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Prior art keywords
nerve
response
stimulus
electrodes
array
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CA002223682A
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French (fr)
Inventor
David E. Coats
Stephen A. Raymond
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Brigham and Womens Hospital Inc
UroMed Corp
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Individual
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/05Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/48Other medical applications
    • A61B5/4887Locating particular structures in or on the body
    • A61B5/4893Nerves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014External stimulators, e.g. with patch electrodes
    • A61N1/36021External stimulators, e.g. with patch electrodes for treatment of pain
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36071Pain

Abstract

An apparatus (10) and its method of operation for stimulating andlocating a nerve includes a probe (12) having a plurality of electrodes for applying a stimulus from stimulator (14) and receiving tissue response thereto and a controller (16) for the stimulator (14) and the response detecting means (18). An audible tone module (20) provides a further indication of tissue response to the stimulus from stimulator (14).

Description

W O 96/39932 PCT~US96/08858 Apparatus and Method for Locating a Nerve Background of the lnvention Field of the Invention S The present invention relates to an a~alalus and lmethod for stim~ ting and locating a nerve. More particularly, the present invention is an ~paldlus and method for precisely stim~ ting and locating a nerve using a closed-loop, automated system.

RP~ntP~ A~t Over the years, nerve stim111~tors have been used as a means to effectively locate peripheral nerves for surgical and ~la~t;uLic purposes.
Such purposes include, for example, loç~1i7~tion of the nerve for the a~lmini~tration of regional ~nPsth~si~ or to avoid cutting the nerve during sectioning or excision of tissue. Nerve loc~1i7~tion via the application of electrical energy is based on the fact that a pulse of electricity can stim-11~t~
a nerve fiber to contract an innervated muscle or cause paresth~si~ in the case of sensory nerves. It is known that if the site of stimn1~tion is a ~ignifi~nt ~nre from the target nerve, a stimn111c of high h~ iLy is required to effectively stimlll~tp the nerve. If the site of stiml~l~ti~ n is relatively close to the nerve, a low illlensily stim111nc is sufficient to stim1-1~t~P the nerve.
Conventional nerve stim111~tors have taken the form of an in~ tPr~
hypodermic needle coupled to a source of electrical current. To locate a nerve, the needle is placed within the tissue of the body in what is believed to be the vicinity of the nerve to be located. The needle is then manipulated by the operating physician, while ~imll1t~nPously applying pulses of e1ectri~
current to the target area. Effective stim-ll~tion of the nerve is confirme~l by visual detection of mnsr,~ r contractions or by a report of paresth~ offered by the patient. Based on a subjective evaluation of the perceived effecliv~llessof each stimllllls pulse, the o~,lalillg physician repositions the meedle and applies subsequent stimuli to the target area until loc~li7~tion of the nerve isachieved.
Some nerves are "complex" in nature because they are microscopic, include multiple br~nrll~os, or are located within "messy" ellvilo~ ents of the body. Such factors render loç~li7~tion of a nerve tliffir-llt to accomplish.
Still other nerves evoke response patterns which may not be innm~ tely ~letect~ble by visual observation alone and are, therefule, rlifflrlllt to illL~by the c~c~a~ g physician. Stim~ tion of the cavernosal nerve, for example, results in 1) relaxation of the smooth muscles of the arterioles supplying the penis, 2) dilation of the arteries leading to the penis, 3) con.ctrir~ion of theveins carrying blood away from the penis, and, secondarily 4) ~rC~lm~ tic~n of blood within the cavernosa. This type of response is especially flifflrlllt to evaluate because the response may not occur until some time after application of the stimllhls. Indeed, measurable t~lmloscenre of the penis may not occur until two or more seconds following sllrcessful .stimlll~tion of the cavernosal nerve (if at all). Given the above-described factors, it is tlifflrlllt for an ~ dLhlg phy~,iciall to locate a nerve via visual inspection of the response pattern.
Nerve stimlll~tors ~;ull~llLly known in the art are dependent on the skill of the operating physician to 1) ~r~c;lly manipulate the stimllll-~ applying means, 2) modify the illlel.~,iLy of the stimlll~l~ and 3) accurately assess thelocation of the target nerve based on an obsel ~aLion and h~ L~ion of the elicited response.
Examples of two conventional nerve stimlll~tors are disclosed in U.S.
Patent No. 3,682,162 to Coyler and U.S. Patent No. 4,515,168 to Chester et al. The Coyler patent discloses a combined electrode and syringe needle which acts as a stimlll~tion probe when the syringe needle is conn~cte~l to an electrical supply. The Chester et al. patent discloses a nerve stimlll~tor W O 96/39932 PCT~US96/08858 formed by clamping an electrode to the syringe portion of an ~n~sth~si~ needle assembly. The device of the Chester patent includes a power supply, a pulse ge~ atillg circuit, and a m~ml~lly controlled current-adjusting potentiometer which allows the O~clatOl to m~n~ ly adjust the current supplied to the stimlll~ting needle.
Although both of the above-described devices may be used to stimlll~
a nerve, actual loc~li7~tion of the nerve is .liffi~ t, slow and illll,lccise because the ope,al(~r is ~c~l~ollsible for pelrol"lillg each step of the loc~li7~tion techni~llle. That is, the opelàlor must place the needle within the tissue of the body, deliver a stim~ lc to the tissue, watch for a response (or query the patient for a response in the case of a senso,y nerve), hlL~ lc~ the ~c~onse, reposition the needle, and apply a s~bseqllent stimllllls to the nerve. The devices of the Coyler and Chester patents are not provided with a means for det~cting or illlel~ielillg sllcceC!~rl~l stimlll~tion of the target nerve, nor do they include a means for autom~tir~lly varying the location of the stimlll~ls site.
Thus, the operator must be able to precisely move and hold the needle, as well as pay close attention to the associated muscle to avoid mi.c.cin~ any con~raction of the illnelvated muscle or other anatolllical cue which may be indicative of sllccescful nerve stimlll~ti-)n. Such a t~hniqlle relies wholly onthe skill of the operator and can be time CO~ g and inaccurate. If the Op~;laL~l inad~ellt:l,lly moves the stimlllllC applying means, llli~ult~ ~ the response, or is not paying close attention to the surgical field, the nerve willnot be accurately located. The skill of the ~.ator is especially critical for loc~li7ing complex nerves (such as the cavernosal nerve) for ~e reasons ~licc lssed above.
Still another device for locating a motor nerve is disclosed in U.S.
Patent No. 2,704,064 to Fi_zell et al. The Fi77ell et al. patent discloses a ~u~ cclll~r stimlll~tor having two probes for passing a current to a sub~uL~Ieous nerve. The probes are placed on the patient's body in the area of the nerve to be stimlll~te~l As a current is passed to the probes, the operating surgeon watches for a l~ llse to stimlll~tion of the r~erve. If a W O 96/39932 PCT~US9Gi'C--~8 response is observed, the surgeon ~sl-mt~s that the target nerve is within the vicinity of the stim~ ting probes.
While the device of the Fizzell et al. patent may be useful for the purpose of stimlll~ting a nerve within a target area, precise loc~li7~tion of the nerve is not possible without close obse.~Lion of the innerva~ed muscle because the Fizzell device does not include an ~ulolllaLic response detection means. Like the Chester and Coyler patents, the operator of the Fi~ell device must be capable of m~int~3ining the stimlll~fin~ probes in place to avoidslight movements in probe position which will affect the ability of the operatorto accurately locate the nerve.
Still other devices aL~ L to stim~ te a nerve at a sizeable ~ t~n~e rrolll using relatively large electrodes at high i "~ s (i. e., greater than 10 rnA). Stim~ tion of a peripheral nerve at such an hlL~llsiL~ is not useful for ~he purpose of refined loc~li7~ti-)n of a nerve, as the response to such a stimulus may be so large (i.e., ~tul~Led) that subsequent movennent of the electrode closer to the nerve (or farther from the nerve) yields no ~l~tect~hle change in the l~ onse. In order to determine the ~ t~n~e between the elec~rode and the nerve, the operator must be able to detect and hlhl~l~e~ any change in the response to sll~ces~ful nerve stimlll~tion.
In an effort to automate the technique for locating a nerve, Raymond et al. developed a device for autom~ti~lly detecting and evah-~ting a response of a nerve to stimuli of varying illlellsiLy. Such a device is disclosed in U.S.Patent Nos. 5,284,153 and 5,284,154 for use in loc~li7ing nerves for delivery of local an~sthtosi~ and for protecting nerves against inadvertent cutting during 2~ surgical procedures. The device of the Raymond et al. patents includes a stim~ ting probe or needle, a response ~letecting means, and a means for autom~tir~1ly mo~nl~ting the intensity of subsequently applied stimuli so that the stim~ ting device Illtim~t?ly converges to a stimnl-l~ illL~lLsiLy known to s~lcces~fully stimnl~te the nerve when the probe is within a certain ~ t~nl~e.
While loc~li7~tion of single fiber nerves is efficient and rapid using the Raymond et al. device, it is diffirlllt to locate multiple branches of a nerve or - =

W O 96/39932 PCT~US961'~B~.~8 to locate nerves (such as autonomic nerves) having a long delay (greater than 1 second) belweell effective stim~ tion of the nerve and the onset of a ~letect~ble, measurable ~ ollse. Fu~ llllore, the response to stim~ tionof some visceral or aulullo",ic nerves (such as tne cavernosal nerve) may persist S for several seconds after the ces~tion of s~1cces~rul stimlll~tion. This delay and ~e~ re of the response makes ~lltom~t.o-l convergence to a predel~.."il-~od stim~ ls nll~ y, as taught by the Raymond patents, slow (taking 20 seconds or more), as well as ~1ifflrlllt to sustain since re*,ollses to small movements of the probe (which may erÇeclively increase the tli~t~nre beLweell the probe and the nerve) will not be ~1etect~ble until many seconds after tne movement occurs. Thus, the ability of tne o~el~ting ~.ulgeoll to ~r~p~,lly move and hold the stimlll~ting probe at a particular location for a period of time is critical in order to s~lcce~fully locate the nerve using the conv.,.~ ence method of the Raymond et al. patents.
With respect to nerve loc~ tir,n for surgical purposes, there relllau~.
a need for a device which is not dependent on the skill of the operator (i.e., ~uLc~laLed) and is capable of taking into account tne factors described above to enable the user to precisely and rapidly locate the target ~erve using stimlll~ting pulses of minim~ iPS.
With respect to a method for locating a nerve (in particular, the cavernosal nerve) there is a need for a method which is capable of autom~tir~lly locating a nerve using small electrodes at low stimlll~ls ",It;nsilies. Metnods ~;ull~nlly known to those skilled in the art utilize largesingle electrodes, multiple large electrodes disposed on a probe, or cuff elec~rodes at relatively high ;.~ ;,os (see e.g., Shafik, A., Cavernous Nerve Stimlll~ti-)n through an Extrapelvic Subpubic Approach: Role in Penile Erection, Eur Urol, Vol. 26, pp. 98-102, 1994 and Martin et al., Tniti~tion of Erection and Semen Release by Rectal Probe Electrostim~ tiQn, Journal of Urology, Vol. 129, pp. 637-642, 1983.) There is also a need for a mrth~ which is capable of aulol~l~tir~lly rletecting and ev~ ting small changes in response ~ lls and of ~ ~ - ~

W O 96/39932 PCT~US9G/O~Q~

compensating for delay in the response to succçscfill stim~ tion of the nerve.
There is also a need to a~ltom~tP the movement between sites of stim~ tion.
While the device of the Raymond et al. patents is capable of autollldLically rletPcting a response, there is no means for inle~ Lmg small changes in the S response for the purpose of ~ ir-ally modifying the site of subsequent stimnl~tion In addition to locating nerves for surgical purposes, nerve stim-ll~tors have been found to be beneficial for therapeutic ~ul~oses. For example, stimlll~tion of the cavernosal nerve (either transrectally or by an implant) hasbeen envisioned as a Lle~ for impotence. Devices which have been developed for the purpose of stimlll~ting the cavernosal nerve are disclosed, for example, in U.S. Patent No. 3,941,136 to Bucalo, U.S. Patent No.
4,124,028 to Gallo, and U.S. Patent No. 4,663,102 to I31ell...aL. et al.
Although all of the afore-mentioned patents disclose devices which are capable of delivering a stimllhl~ to innervated body tissue, none disclose an d~alalus and method which precisely and ~lltom~tie~lly locate a nerve for optimal stimlll~tion thereof.
The Brenman patent, in particular, discloses a stimul~ting device which is inserted into the rectum of the patient to a stim~ te penile erection. The device includes electrical cil-;uilly for ge-~ i,.g an electrical signal to be applied to the pelvic nerve. Electrodes, placed at specific locations on the surface of the device, apply the signal to the patient. At least one of the electrodes closely contacts the prostate gland when the device is operatively disposed at a region or spot on the prostate gland previously ~eterm;nPd to be sensitive to elPctr~ l stim~ tion. k1Pntif;f~tion of the spot or spots to be stimlll~t~l by the device is accomplished by a se~a,dle, glove-like appalalus which in~llldes a plurality of electrodes mounted thereon. After selecting the desired stimlll~tion site or sites with the glove, the stiml-l~ting electrodes are positioned on the device (in accordance with the electrode positioning of the glove) so that the electrodes contact the "hot spots" when the device is positioned within the rectum.

W O 96/39932 PCT~US96/08858 klentifi~tion of the hot spots via the 131c~ all device may be inaccurate, however, in light of the fact that the physician is ~ onsible for manipulating the glove-like device and for visually ~letecting and mo~ oli~g the tl1mrscenre lcspol~se (i. e. the ~lc~ an device is not an automated, closed-loop system). Rec~1se the Brenman device is not ~11tom~tç~1, it is not capable of taking into account the afore-described factors of the cavermosal nerve system, inr111~1ing the delay which occurs between s11rcescful stimnl~tion of the cavernosal nerve and the onset of tumescence. Moreover, it would appear that accurate p1~r~mrnt of the electrodes on the stim111~ting device is ~lifflc llt since i-lentifir~tinn of the hot spots is accomplished usimg a s~le, glove-like a~aldLus which is structurally dirr~.~nL than the device. Finally, should the rectal tissue shift, the I~relllllall device provides no means to collrlllll that the electrodes of the device are still optimally aligned with the hot spots of the prostate.
Still other devices for tre~tm~nt of impotence (such as the Gallo device, for example) utilize especially large electrodes which ~tim11l~te the tissues of the body at high i~ s. As stated above wi~ respect to nerve loc21i7~tion for surgical purposes, stimlll~tion of the nerve at a high hlLe~ y may result in a salul~ted response which is ~1ifflr111t to hl~ t for the purpose of ~l~te-.. i1-i'-g the location of the stimlllll~ applying means with respect to the pelvic nerve. In addition, a high hlL~nsily stim11111s by a largeelectrode produces a diffuse spread of electrical current that may stim11l~te a nerve other than (or in addition to) the target nerve and which may reduce the user's ability to stim11l~t~ the target nerve. Furthermore, stimlll~tion at highhlL~nsiLies is known to cause the subject considerable pain and discomfort.
Large electrodes are h~lopliaL~ either for m~ximi7ing a response or for ioc~li7ing a nerve. The current density is ~ ir~e~l by the large area of the electrode, m~king local nerve stim~ tion more tlifflr111t (for constant current source stimlll~tion). In the case of voltage source stim~ tion, an exree~ling1y high level of net energy is applied to the tissue of the body via a W O 96~9932 PCTAJS96/08858 large surface electrode. Indeed, ~e energy may reach the point of actually heating tissue to dangerous levels.
Thus, for therapeutic treatment there is a need for a nerve stimnl~fin~
and locating device which is not dependent on the skill of the user and is S capable of precise location by taking into account the factors of an autonomic nerve system. A device which is capable of stimnl~ting a nerve at low ;..lr..~ içs to decrease or altogether avoid patient discomfort is also desired.
Summary of the Invention It was with the above-described needs in mind that the present invention was developed. In light of the fact that surces~ful loc~li7~tion of the target nerve is dependent upon the skill of the opeLatol, and more particularly on tlhe position of the probe, it has been envisioned that stim~ ion of the nerve by a means which dulo~ ;r~lly varies the site of stimnl~tion may be more effective than stim-~l~tion by a single, physically manipulated electrode.
This is particularly true where the nerve fibers are distributed over an area such that a single electrode cannot effectively stimnl~tP the erltire nerve bundle. Accor~ gly, the present invention is an a~a,dlus and method for locating and stim~ tin~ a nerve at specific stimllllls paldlneL~ls which are known to stimlll~te the nerve when the stim-llnc is applied to the nerve within a certain di~ r-e. In the plef~ d embodiment of the invention, the site of stimlll~ti-1n is electronically "floated" over the target area by an array of stiml-l~ting electrodes. Activation of the array is governed in accordance with an electrode selecting algoliLhll~ which autom~tir~lly h~Lel~l~ts and evaluates the lresponse of the nerve to s lccecsful stimlll~tion to deL~lnlille which electrodes are sllccessfully stimlll~tin~ the nerve. Because each step of the locating method is autom~ti~lly controlled, the skill of the opeldtor is no longer as important a factor in s~lccessful nerve loc~li7~tion. In this sense, the dppa~dlus and method of the present invention is closed loop.

W O 96/39932 PCTrUS96/08858 _9 _ In one aspect of the invention, the app~dlus for locating and ~ stim~ ting a nerve includes a means for applying a stimulus to a nerve at a plurality of sites, a means for ~letçcting a response to a stim~ s, amd a means for autom~tir~lly modifying the site of stim~ tic n. The means for S ~ "~l ir~lly modifying the site of stim-ll~tion includes a means for illLGl~lGtillg the response provided by the .c~vllse (1çtectin~ means. The meams for applying a stimllln~ to a nerve may be an array of stimlll~ting electrodes, a m~gnPtir induction device, or an electrode movably positioned on a track. The electrodes of the array may be arranged iEn a multi-.limf ncional configuration for activation in sl~ccessive triplets to d~ Pille the longi~1t~ in~l axis and symmetry of the nerve. The illL~.~lGLillg means illL~lplc~LS data from the response detection means to ~li.cc;.;",i";1te bGLweell trends in response states corresponding to periods of s~ccç~rul stim-ll~ti~ n and states corresponding to llncuccessful stimnl~tion of the nerve.
In another aspect of the invention, an a~dlaLus for stimlll~ting and locating the cavernosal nerve is provided. The appa~dLus includes a probe havi ;lg an array of electrodes, a control means for governing activation of thearray of electrodes, and a response detection means for tlçtecting and mea~ulillg a t lmrsr,çnre response. The electrodes of the array are activated in accol-ldl~e with an electrode selecting algoliLlllll which evaluates a m~occenre response to sl~ccescful stimlll~tion of the cavernosal nerve. The response detecti~n means provides response feedb~rl~ information to the control means for evaluation by the electrode selecting algoliLI~l. A
11lmrsce~re monitor CO~ liSillg a mercury-filled (lictencihle tubing may serve as thLe response det~ctic-n means. The a~dldLus may also include a filter to isolate ch~n~ec in the tllm~scence response from changes in~ ceA by other aspects of the locating or surgical procedure. If desired, the most distal electrode of the array may be angled at approximately 45~ to position the electrode at the physical tip of the array, thus allowing the array to function as a single electrode or pointer. The apparatus may also include a means for in(lir~ting to the user the location of the nerve to the user.

_ -W O 96/39932 PCTAJS96/088~8 In another aspect, the invention is an a~aldlus for locating and optimally stim~ ting a nerve for therapeutic purposes. The a~alallls includes an implant comprising an array of electrodes, a control means for gOV~ ing activation of the array, and a response detection means. The control means of the apparatus activates the electrodes of the implant in accordance with an electrode selecting algoli~ which evaluates a response to s~1oce~sful stimn1~tion of the nerve. The response detection means of the a~aLus provides response feedb~c~ information to the control means for evaluation by the electrode s~lectin~ algol;Ll-lll. The implant may take the form of a stent which is implanted within a natural body cavity of the patient. The response etrction means, particularly for cavernosal nerve stim~ tion~ may be a ~"~rSce~re monitor.
In yet another aspect of the invention, a method for stimnl~tin~ and locating a nerve is provided. The method includes the steps of applying a stim~ to a nerve, detçcting a response to stimn1~tit)n of the nerve, ev~1n~ting the response to stim~ tic)n of the nerve, and autom~tir~11y modifying the site of stimn1~ti~ n based on the evaluation of the response. The stimn~ is of an hlLel~ y known to stimn1~tP the nerve when the site of stimn1~tion is within a known ~ re from the nerve. The site of s1im111~tinn is modified in accordance with a site selecting algoliLllln which is based on information provided by a response flPtectin~ means and a stimnl~ion input means.
A method for speci~lcally locating the cavernosal nerve is also provided. The method includes the steps of applying a stimn111~ to the nerve to evoke a tumescence response, ~letrcting a t~1mPscçn~e response to stimn1~tion of the nerve, ev~ ting the blmloscence response to the stimn1~ti~n of the nerve, and autom~tir~11y modifying the site of subsequent stim1l1~tiQn based on an evaluation of the tnm~scence response. The stim11l11s is of an hlLel~ily known to stim111~te the nerve when the site of stimn1~tion is within a known ~ t~nre from the nerve, specifir~lly 1 mm. The steps of the method are repeated until loc~1i7~tion of the nerve is achieved. The stimlllllc may be W O 96/39932 PCTAJS~Gi'~5~8 a train of electrical pulses. A t~ oscence monitor may be used to detect a - ~onse to s~cces~ful stimnl~tion of the nerve. The change in the res~ollse pattern may be evaluated by a response hl~ elillg means. The site of stimn-l~tion may be auLo",~lir~lly modified in accordal~ce with an electrode S sel~cting algolill~
In still another aspect of the invention, a method for stim--l~ting the cavernosal nerve to facilitate loc~li7~tinn thereof is provided. This metnod inrl~ s the step of applying a stim--l--c to a nerve which is capable of g sub-m~xim~l tllm~scçnre of the penis such that subsequent hlm~scçnre responses to subsequently applied stimuli occur with shorter delay from the onset of sllccessful stim-ll~tion. The stim--l--c may be el~ctrir~lly, eh~mic~lly, or m~ch~nic~lly applied to the patient.

Brief Description of the Figures Various objects, Ç~aluies and ~ttenrl~nt advantages of the present lS invention will be more fully appleciated as the same becomes better understood from the following det~ilerl description of the present invention when considered in connection with the accolllpallyillg drawings, in which:
Figure 1 is a sch~ ic drawing of the component parts of the apparatus of the present invention;
Figure 2 is a side elevational view of the array probe component;
Figure 3A is a side elevational view of the array tip shown in Figure 2;
Figure 3B is a bottom plan view thereof;
Figure 3C is a front elevational view thereof;
Figure 4 illustrates several devices for use as the response ~l~tectit)n means of the invention;
Figures SA-5C illustrate the latency phenomenon as ~l~tecte~l by a six-minute stim~ tion epoch in a canine ~lepal~lion;
Figure 6 is a plotting illu~Llalillg the change of l~-mPscence versus star~ing t~lmescence;

W O 96~.9932 PCT~US96/08858 Figure 7 illustrates another embodiment of the array probe of the present of the invention;
Figure 8 illustrates an expandable stent having a plurality of electrodes;
Figure 9 is a chart of a library of states or characteristics of a response;
Figure 10 is an illustration of a gauge CO~ lg a plurality of linearly arranged LEDs for co.. ~ir~ting stimlll~tion ~ lalion to the operating physician; and Figure 11 is an illustration of an alL~ aLiv~ stim~ ting device for autom~tir~lly varying the site of stimnl~tiQn.

Detailed Descriphon of the Preferred Embodiments With reference now to the ~It~rh~d Figures, the a~paldLus and method of the ~l~;f~lred embodiment of the invention will be described.

Apparatus of the Invention Turning now to Figure 1, a ~l~rell~d embodiment of the apparatus for locating a nerve is shown generally at 10. Nerve locator 10 generally colllplises a stim-~l~ting probe 12, a stim~ tor circuit 14, a control means 16,and a response ~letectic-n means 18.
As shown in Figures 1, 2 and 3A-3C, stim~ ting probe 12 is generally wand-like in shape and inrl~ es a tip portion 22, a flexible handle 24, a switch panel 26, a flexible cable 28 and a conllc~,Lul 30.
Tip portion 22 is curvilinear in shape and extends approximately 0.760 inches from distal end 32 of handle 24. Tip portion 22 is provided with a pc board 34 to which an array of ~timlll~fing electrodes 36 are connected in a linear relationship. A polycarbonate, or other suitable mf.~1ir.~1 grade plastic, is molded about the pc board and electrode array to form the nnain body element of the tip portion of the probe.

CA 02223682 1997-12-0~

W O 96~9932 PCTAJS96/Q~8 Electrodes 36 are preferably pl~timlm having a rli~mPter of - approximately 200-500 microns. The electrodes should be no smaller than the described ~limPncion~ as a protruding electrode of a smaller ~ mPter may cut or otherwise damage the nerve. Electrodes 36 extend approximately 0.1-0.75 mm from the main body portion of the probe so that the tips of the electrodes may be brought into contact with the tissue to be stim~ t~d As shown in Figures 3A-3C, eight electrodes are positioned on pc board 34 approximately 1.0 mm apart. Although eight electrodes are shown, it should be realized by those skilled in the art that any number of electrodes may be positioned on the pc board at any suitable di~t~n~e. Naturally, the spacing and number of the electrodes may be varied depending on the type of nerve to be stim~ ted and the tissue of the target area. Furthermore, the length of electrodes 36 may be varied for the purpose of locating a nerve which is deep within the tissues of the body.
In the plercllcd embo(lim~nt the most distal electrode of the array 38 is arranged approximately 45 ~ off the line of the other electrodes so that the tip of the electrode may be used as a pointer or as a means to more accurately posi~ion the array of the probe within or beneath the tissues of the body. In an ~ . .,.l i v~ application of the invention, stim~ tion may be restricted to the most distal electrode of the array for use as a single, m~nn~lly-moveable electrode assembly.
The electrode arrangement illustrated in Figures 1, 2, and 3A-3C is especially advantageous for loc~li7~tion of the cavernosal nerve, as the most distal electrode of the array may be directly placed beneath the prostate and below the urethra. Naturally, more than one electrode may be offset at any ~ angle to facilitate positioning of the probe in any desired area. Similarly, the tip portion of the probe may be otherwise contoured to allow the tip portion of the probe to conform to the surface area of the tissue to be stimlll~t~-l It is also envisioned that the tip portion of the probe may be formed from a plastic which is capable of closely collfo~ illg to the surface area of the tissue to be stimlll~t~

CA 02223682 l997-l2-05 The plcrellcd ~limencions of the tip portion of the probe are listed below (in inches) as iclentifie~ in Figures 3A, 3B, and 3C of the dld~illgs:

Length A .760 Diameter B .300 Diameter C .238 Width D .070 Width E .150 Width F .075 Naturally, the tip portion of the probe may be otherwise dimensioned in acc-~r.lal-ce with the type of nerve to be located and its location within the tissue of the human body.
Colle~olldingly positioned above each electrode is a small light emitting diode (LED) 40 which in-lirAtPs to the user which electrode has sllcce~fully located the target nerve (that is, under which electrode(s) the target nerve, or br~n~ s thereof, lies). Each LED is approximately 1 mm in ~liAm.Qter and corresponds in location to the spacing of the electrodes. If the nerve to be located is in a "messy" surgical environment (that is, if there is a lot of blood or other bodily fluids/tissues in the surgical field), the c~el~or may not be able to visualize the LED array of the device. It is, therefore, desirable to provide a second array 25 (Figure 2) along the handle portion of the probe to enable the operator to see which electrode has sllccessfully located the target nerve.
At its proximal end 32, tip portion 22 of probe 12 is joined to a handle 24 which enables the user to properly position the probe within the body tissue. Handle 24 is made mAlleAhle by providing a copper wire 48 of 8-12 gauge through the central core of the handle. Handle 24 is preferably formed from any suitable medical grade plastic which exhibits a certain degree of flexibility and is capable of being sterilized. Formed in~egral with handle 24 is a panel 26 which includes switches 44 and 46 for inil;AI;ng and terminAting the various stimlllAting modes of the al~pal~Lus. Extending from panel 26 is a patient ground lead 50. Electrodes 36 are preferably grounded CA 02223682 1997-12-0~

to a st~inlPss steel spreader plate used to m~int~in the tissue of the patient in - an exposed condition for surgical purposes. If a spreader plate is not available, the ground can be clipped to a silver plate or other implement with a large surface area in contact with any wet body tissue, and preferably axial S to the course of the nerve to be stim~ te(l A suction port 33 (Figure 2) formed within handle 24 is provided to remove bodily fluids from the surgical field which may i lL.,lÇ~,.e with the surgeon's ability to view the surgical field.
At the end o~osiLe handle 24, switch panel 26 is conrPcte~l to a silicone j~cl~te~l, flexible cable 28 which is approximately 12 ft. in length tolend the o~ dL-ng surgeon an o~L-.l.u.n range of mo-ve.-le,lL. A cable similar to that for use with an electrocautery probe is suitable for the purposes of thepresent invention.
Molded on the end of cable 28 is a suitable 9-wire connector 30 for coupling the probe of the apparatus to the control means of the invention.
Such a connector is available from Lemo, Basil, Switzerland.
Stim~ tc-r circuit 14 generates a symmetric biphasic square pulse current in response to a trigger by control means 16. The circuit initially converts a digital number to a voltage level beLweell 0-5 volts. An i~lvellhlg unity gain circuit Ll~rOlllls this single voltage level into two symmetric levels, one positive and one negative each having a m~tf lling amplitude. The digital to analog Collvt:llol voltage is varied by plUgldlll control between 0-5volts. A standard timing board (such as the CTM ~5 available from Keithley Metrabyte, Taunton, M~.s~chllsett~) is used under program control to control a silicon switch (e.g., a DG 300, siliconix, or like switch) to connect first the negative and then the positive voltage to a ~ g operational amplifier (op-amp) "adder", thus forming a biphasic voltage pulse whose amplitude is governed by the DAC voltage and whose timing and duration of each phase is governed by the two pulses from the timing card. The two pulses are sepaldted by 1 ,us such that the t~,vo phases of the biphasic voltage pulse combine se~aldtely at the output of the adder. A voltage-controlled current CA 02223682 l997-l2-05 W O 96~9932 PCT/U~,G/0 ~;en~ ol using op-amp driving high voltage current mirrors co~ L~l to high voltage batteries coll~,elLs this biphasic voltage signal to a pulse of constantcurrent which is deliverable to the target area by stim~ ting probe 12. The current pulse ranges from 100 ~bs-1000 ~s in the duration of each half pulse S and in amplitude from ~t200 ,uA to ~t25 mA. The delivery of such pulses to particular electrodes of array 36 is accomplished by a set of relays ~ct~l~tPd under program control. It should be noted tnat the stimllllus generated by stim~ tor circuit 14 may be in isolated pulses or in sllst:~inP~l trains of either regularly timed or irregularly timed pulses. Thus, a single stimlllll~ may colllplise a single pulse or a train of multiple pulses. The importance of a pulsed stimllllls viz-a-viz a continuous stimulus will be described in more detail below.
Control means 16 com~lises a colll~uL~l which utilizes data acquisition haldwal~ and software. An Intel 80386 DX conl~uL~ and a Metabyte-16 data acquisition board (available from Metabyte Corporation, Taunton, M~s~rhlleett~) are suitable for the purposes of the present invention. The data ~cqlli~ition board should have at least a one channel (12 bit) analog-digital converter, one or two digital-analog collvt;ll~.~, and timer chips. The data acquisition sor~waLe is written to hllc.pl~L a response from response ~1et~cti~ n means 18 (to be described in more detail below) in acco,da"ce with a response illlt.~r~ling and electrode selecting algolill,u,. The response illlel~l~,li,lg and electrode selecting algorithm of the control means is a function of the nerve to be located and is based on elllpi,ical data. The algo.il~n is premised on response pattern recognition and may take into account many factors, 2~ including the multiple phases in the response pattern of an autononnic nerve, the delay between succe~ful stim~ tion of the nerve and tne onset of a ~letect~ble response, and the stim~ tion and response history of the nerve.
This ,nru-l"ation is used to formlll~te a response i"L~lpreling algo,illll,l which ~leL~ Ps whether a particular electrode of the array has successfully stimlll~te(l the nerve.

-W O 96/39932 PCT~US96/088~8 The l~ollse hlL~ lillg algo~ llll is based on a library of response - states derived from empirical data. This library of states may be caLt;goli~ed as shown in Figure 9. The listing of states det~ilerl in Figure 9 is a lese.~ on of some of the possible conditions or cl~.;hlislics of any S givem response. The "level" of the response is chalacL~ ed with respect to a pre-~et~rmin~d baseline value for the particular nerve to be located. The response hlL~l~r~Lillg alguliLl~ lete,...i.~s whether the response is above baseline, at baseline, below baseline or â gradation thereof.
The response "trend" is evaluâted in light of the direction of the previous level of the response. That is, the algoliLl,.n tlete.. ~ os whether the response is rising, stable or falling in COlll~dliSOIl to the previous level of the response.
The "relative level" of the ~esllullse is also evaluated with respect to the previous ~ onse level. For example, the algolilll,ll considers whether the response is greater than or less than a recent m~ximllm response. There is an implied variable in the "relative position" with respect to a time interval which may be defined by 2 epochs timed at 20 and 5 seconds, for example.
Each response includes an "acceleration" plc~elLy which is indicative of the rate of change of the response. This characteristic is evaluated against a pre-determin~ criterion value of acceleration and is based on a time interval which may be eva~ t~d, for example, every S seconds.
The "stimlll~l~" state is in-lic~tive of whether the stim~ s is on, off, recently applied, or recently stopped for that resyollse record.
Each response is evaluated and ch~dcLt;li~ed at a time, t, as set forth above. For example, the level of the response may be above baseline, rising at a rate of change greater than criterion, and positioned relative to a recent m~ximllm For each combination of states, the algorithrn will determin,o whether the response is indicative of s~lcces~ful or lm~ucces~ful stimlll~tion of the nerve. After categoli~illg the response, the algo,iLl-.ll works backwards (taking into account the delay factor) to determine which electrode or electrodes were responsible for sllrcessfully stimlll~tin~ the nerve. Based on CA 02223682 l997-l2-05 W O 96/39932 PCTrU~;O~X

this evaluation, the electrode selecting al~oliLllnl of the co~trol means sets up a subsequent stim~ -s train among that subset of electrodes. Ongoing stim~ til~n of the target nerve is restricte(l (as go~ ed by the algo~ ) to a subset of the array which produces a criterion response with the least S m~nitnlie of sffm~ tion. The algo~iL}l~ll continues to illl~ L the response to successful (as well as lln~llcce~ful) stim--l~tion of the nerve until the location of the electrode(s) closest to the nerve is illPntifiPtl Upon locating the nerve, the LED(s) corresponding to the electrode lying imme li~tely above or adjacent to the target nerve (or branches thereof) is ilhlrnin~tto(1 to in~1ic~t~
to the operator the location of the target nerve beneath the array.
In another embodiment of the invention, control means 16 may be provided with a separate inrlir~tor program which audibly inrlir~tes to the userthat the target nerve has been located. Loc~li7~tion is in-lir~t~-l to the user via a tone module 20 of constant or variable pitch.
With reference again to Figure 1, the response detection means of the present invention will now be described. As shown in the srh~m~tir of Figure 1, response detection means 18 is shown conn~cte~l to control means 16 of the device. Response detection means 18 functions to detect and measure a response to successful stimlll~tion of the target nerve. The m~gnihl-1e of the response is recorded by the response detection means and Çol wal~edL to control means 16 for i ll~ L~Lion by the algorithm of the device. Control means 16 h~Lt~lpl~LS the response data provided by response ~let~ction means 18 in order to determine which electrode or electrodes of the array were responsible for successful stimnl~tion of the target nerve. The response data is evaluated by the algorithm in accordance with the stim~ tion and response history of the nerve and the other factors ~ c~secl above which tend to complicate loc~li7~tion of the target nerve. As the response information is received and ~ e~pleled~ the electrode selecting algolilllnl of the invention flet~nin~s which subset of electrodes will receive the next stim~ tion pulse. l[he device contiml~ to stimlll~te the nerve (and hlL~lpr~t the response thereto) until loc~li7~til n of the target nerve is achieved.

W O 96/39932 PCT~U~9 -19- . ~

Selection of a device to detect and measure a response to s~ccessf -l stimn1~tion is dependent upon the nerve to be located. For example, if the user is dlL~ Lulg to locate a sensG,y nerve, any means capable of detçctin~
and measuring action potentials within a nerve fiber may be used to accomplish ~e objectives of the invention. For motor nerves, any means capable of ~letecting and m~llring a response of the innervated muscle or organ is suitable. For the cavernosal nerve, in particular, any means capable of ~lelecli"g and measuring t lm~scence of the penis (or dilation of cavernosal blood vessels, or other direct results of stiml-l~ti~-n of the cavernosal nerve)may be used to enable loc~ tion of the nerve. Devices capable of cletçcting and mP~ g penile L~ osce~ e are disclosed in Figure 4. Such devices include distensible tubing 52 filled with a conductive fluid (such as mercury), EMG electrodes 54, and a Doppler flow head 56 which is position~cl on the dorsal artery of the penis P to image the same. If EMG electrodes are used, an arnplifier must be incol~oldled into the device to boost the ~letecte~l signals to levels ~rol,liate for analog-digital conversion by control means 16. A
laser Doppler flow head (not shown) for measuring capillary flow within the tissue of the penis may also be used. Increases (or decreases) in l~m~scen~e may be also be tletPcte~l by a needle capable of ~1etecting changes in ~l~;s~iule within the spaces of the erectile tissues of the penis. Still other devices for m~ lring ~lmtoscçnre include a condom or sheath-like device which is capable of ~letecting ch~nges in resi~t~n~e as the volume of blood within the penis changes. It is also envisioned that t--m~scenre may be measured in terms of tissue density by an ultrasonic ap~ardLus. Naturally, other devices capable of cletecting and m.o~cllring a response to s~lcces~ful stimnl~tion are suitaLble for accomplishing the objectives of the present invention.
In the ~lerelled embodiment of the invention, a non-linear filter to elimin~te noise from a surgical knife (or noise from other irrelevant surgical illL~l vc;llLion) is provided to assist in the cletçction of the very earliest signs of effective stimnl~tion. Other filters for optimally enhancing signals are used in the signal detection circuits of the response ~letecting means.

W O 96/39932 -PCT~US96/08858 With reference to Figure 10, it is envisioned that the a~palaLus of the invention may be provided with a separate gauge consisting of a plurality of linearly arranged LEDs which may be ilhlmin~t~fl to col.""l"~ir~t~ stim~ tion illfollllation to the operating physician. For example, the left end of the gauge could be illnmin~te~l (as ~irt~t~d by the control means of the appaldLus) to inAic~te to the plly~iciall that the last s~lccescful stimnl~tinn epoch occurred 60 seconds ago. The middle portion of the gauge could be illnmin~te~ to inAic~t~
that the last succç~sful epoch occurred 30 seconds ago, while the right-hand end of the gauge could be illllmin~tP~l to in~1ic~te that ~rcçs~irul stim~ tion occurred 1 second ago. Naturally, the gauge may be provided with any number of LEDs and may be illnmin~te(l to co"""""i~tto any type of information con~ ing stim~ tion of the nerve. It is also contemplated that the LEDs of the gauge may be colorized to reflect effective (or i,lerr~cLiv~) stimlll~tion of the nerve.

1~ Operation of the Apparatus of the Invention Having described its component parts, operation of the ~al~s will now be described.

Pnming For certain types of nerves (such as the complex, autonomic nerve described above), it has been found that "pre-conAitioning" or "priming" of the nerve assists in loc.~ fion in a more precise and expeditious manner by disposing the system to respond more quickly and to a greater degree to a subseq~çntly applied stimulus. As noted earlier in this application, autonomic nerve (such as the cavernosal nerve) may be characterized by the fact that there is a time delay between succes~ful stim~ tiQn of the target nerve and the onset of a ~letect~ble response (that is, the response of an innervated muscle or organ does not imm.oAi~fely follow sllccçs~ful stiml-l~tinn of the nerve).
-W O 96/39932 PCT~US96/08858 The results of recent studies in-lir~t~: that this time delay may be decreased by applying "priming" stimuli of sub-saturation i~ y to the target nerve. As stimuli of such an illlel~iLy are applied to the target nerve, the response of the associated muscle or organ is evoked more rapidly and to a larger m~gnih~
S when subseqlnPnt stimuli are delivered within an a~ iate delay (2-60 sec)from the priming stimuli. This decrease in the time delay assists in loc~li7~tion of the nerve, as each change in the response (i.e. the dirr~r~.l;allc~ollse) of the associated muscle or organ may be more quickly and precisely tied to a particular electrode or stiml~l~ti~ n site. Evidence of the exi~tçrlre of the priming phenomenon will be ~ c~ls~e~l in more detail below with particular lcfel~.lce to loc~li7~tion of the cavernosal nerve.
To prime the target nerve, the ~elator places the electrode array of probe 12 on or near an area believed to contain the target nerve. The operator then activates the priming switch located on handle 24 of probe 12 to initiate the priming mode of the a~dldLus. Upon activating the plil~ lg switch, control means 16 initi~tP~ a stimlll~tion pattern or seq~en~e using either all or a subset of the electrodes of the array. The illL~siLy of the stim--h-e train to be applied to the nerve generally ranges between 2-10 mA, 100-800 ~4s, 5-30 Hz and is dependent on the type of nerve to be primed.
That is, the software which governs the priming mode of the a~pd~dLus is based on a fl~t~h~e of information which is specifically directed to effective stim-ll~tion of the target nerve at various stimlll~ting hlL~llsiLies and ~ t~n~es.
Thus, for the priming mode of the invention, the control means prescribes a stim--l~ting sequence of a constant or variable inLellsiLy which has been previously d~ t ",; ~PA to evoke a sub-saturation response for the type of nerveto be located.
Control means 16 continues to run the pre-defined priming sequence without stopping to actually locate the nerve. The control means never stops to consider which electrode is sl~ccessfully stim~ ting the nerve, but contimlesto run the same sequence to record stimlll~tiQn hlfo~llldLion for use during thelocating phase of the invention. In this respect, the priming phase of the W O 96/39932 PCTrUS96/088~8 invention is "open-loop" in that the control means does not evaluate or hltel~let the response of t_e nerve for the purpose of locating the same with respect to the electrodes of the array. Sufficient prirning of the nerve is achieved when t~m~osce~re of approximately 10-20% of the m~ximnm tllm.oscP~re has been achieved.
It should be noted that priming of the target nerve may also be accomplished by using a single electrode of the array at a sub-saturation intel~ily. Regardless of the number of stimnl~tin~ electrodes to be used, the application of stimuli of a sub-saturation illL~ y will serve to prime the nerve for the purpose of decreasing the time delay belweell effective stim~ tion and the onset of a measurable response.
Although priming of a nerve has been described using stim-ll~ting pulses of electricity, it should be noted that l,.i".;n~ of a nerve may also be achieved chPmir~lly or merh~nir~lly. For example, the patient may be injected with a drug known to evoke a desired response from a muscle or organ i~ /aL~d by the target nerve. To achieve a penile erection, for example, the patient may be injected with papaverine for the purpose of priming the cavernosal nerve. ~ltern~tively, the nerve may be stimnl~ted mPcl~nir~lly by a applying a vibrating pulse to an approplialc area of the patient.
While the priming step of the invention facilitates rapid and precise localization of the target nerve, it should be noted that priming is not required to s~lcce~cfully locate the nerve. The algoli~llll of the invention will result in loc~li7~ti-)n of the nerve whether or not the plilllillg step is pel~olllled.

2~ Locating Following priming, the device is switched to the locating mode to actually locate the nerve. At this stage, the appaldLus of the in~ention is "closed-loop" in nature in that the control means ill~ lcls a change in the response pattern for the purpose of deterrnining which electrode of the array W O 96/39932 PCT~US96/08858 is responsible for stim~ ting the target nerve. This operation is independent - of the o~el~tor and is Lherefore more accurate and precise than previously known nerve locators which are dependent on the skill of the operator to manipulate the device and hll~ L response feedback illÇollllation.
S Upon activating the locating switch of the ~l~paldLUS~ the electrodeselecting al~ol;Lhlll of the control means i~ tes a pre-arranged sequence among all or part of the array. It should be lm(lerstood that the electrodes of the array may be fired in any particular order or sequence.
The stimllllls pulses of the locating phase are of an hlLensily capable of e~reclive stim~ tiQn of the target nerve when applied within a ~ f~n~e of 1-2 mm. As the electrodes are fired in the pre-arranged sequence, the l~,~olLse ~le~e~ g means of the appal~lus detects and measures a change in the response of the associated muscle or organ. A response to sllccee~fill stim~ tion of the target nerve will rapidly occur, as the priming step of the method has erreclively decreased the time delay btLween effective stimlll~tion of the nerve and the onset of a m~ llr~ble l~onse. Response fee~ib~
information from the response ~lel~c~;, .g means is sent to the control means for inLel~leLation by the lcs~onse hl~el~leLillg algoli~llll. The lcspollse illL~ Lhlg means colllpares the absence of a change in the l~ onse at one (or more) sites against a change in the response at one or more other sites.
Based on this colll~ison, the control means (via electrode selecting algolillllll) ~let~rminPs which electrodes were most sllcces~ful in stim~ ting the target nerve (that is, which electrodes evoked a response in~lic~tive of succe~ful stimlll~tion of the nerve). Equally important, those electrodes which were not responsible for evoking a change in the response pattern will be identified.
The electrode se!~octing algoli~ ll of the control means restricts a second stimlll~ting sequence to that set of electrodes known to evoke a response to sll~ce~ful stimlll~tion of the target nerve. The response to the second sequen~e is evaluated by the control means to further detellllil.e the position of the nerve bel1eal~l the electrode array. Based on the stimlll~tion W O 96/39932 P¢TAJS96/08858 and response history derived from the first and second sequence, the control means prescribes a third sequence. The program continues to run until the most effective (i. e., closest) electrode(s) is identified. The electrode(s) closest to the nerve has been ~etçrmin~d to be that electrode capable of evoking a change in the response pattern at the lowest hl~e.~i~y known to evoke a response when the electrode is within 1 mm of the target nerve.
Upon identifying the most effective electrode(s), the LED(s) corresponding to that electrode is ilhlmin~t~-l on the probe tip and on the handle portion of the probe. At this point, the stim~ s pulse may be further decreased to ap~lv~illlately O.S mA to col~ lll that the target nerve is indeed beneath the m~rkeA electrode(s).
It should be noted that throughout the locating phase, the i~ ~iLy of the stimllllls need not be changed in response to ~rr~Live stimlll~tion of the nerve. The ~Lxed stimllll-s hlL~llsiLy selected for the locating phase is capable of locating the nerve when the stimlll~tin~ probe is within 1 to 2 mm of the target nerve. It should be further realized that, like the priming phase, the electrodes of the array may be fired in any order (in either direction) and are not n~cçe~rily fired in seq~lenti~lly adjacent order.

Appli~tion of the Apparatus and Method of the F~ese..l Invention for T,or~tin~ the Cavernosal Nerve It has been found that during radical prostatectomy surgery, the ability of the operating surgeon to locate and spare the cavernosal nerve greatly reduces the othenvise high, post surgery rate of impotence. The apparatus and method of the present invention is especially suited for locating the cavernosal nerve, as it is capable of taking into account the response pattern which is evoked by successful stim~ tion of the cavernosal nerve. The operation of the device with respect to loç~li7~tion of the cavernosal nerve will now be described.

W O 96~9932 PCTrUS96/08858 Evidence of the Eff~ectiveness of Priming the Cave~nosal Nerve For the cavernosal nerve, it is known that there is a time delay between effective stim~ tion of the nerve and the onset of a change in ~.. ~sce~-re. In 1~ , this delay may be as short as 2 seconds and as long S as 30 seconds. Based on eXper1m~o-nt~l studies pelro~ ed on dogs and rats, it has been discovered that s~t~in~o~l stim~ tion at a sub-m~xim~l hllel~,ily will minimi7~ the response delay to a subsequ~lltly applied stimnllls train.
Evidence of the ~rrecLivelless of priming for the cavernosal nerve is illustrated graphically in Figures SA-5C. Figure 5A illustrates a first and second stiml~ln~ epoch of a six-minute canine record, while Figure SB
illustrates a third and fourth stimll~ epoch of the same record. Figure SC
is a s~ ."~ on of the graphs of Figures 5A and 5B. As seen in Figure SA, a first stimlllll~ epoch A was applied to the subject dog at time 2044 for a total of 33 seconds. The par~m~ot~rs of the stimlll~tin~ probe were standardized at a level sufficient to stim--l~t~o- the nerve within a ~ re of 1-2 mln (i.e., 8 mA, 800 ,us, 16Hz). Although the stirnulus epoch was initi~tlq~l at tirne 2044, the response of the nerve did not pass criterion until time 2053, a full 9 seconds after the onset of the initial stim~ epoch. I~us, for the first stimlll~tion epoch, a 9 second delay between stiml-l~ti~ n and an in increase int--m~scence was observed. The second stimnll-~ epoch B was initi~te~l at time 2092 for a total of 8.5 seconds. During the second stiml-l--~ epoch, the response of the nerve passed the criterion level at approxirnately ~ime 2096 a total of 4 seconds after the onset of the second stirnulus epoch. The third stim--l--~ epoch C (see Figure 5B) was initi~te~l at tirne 2147 for 8.1 seconds.After only 1.65 seconds, the response of the nerve ex~eecl~o~i the criterion level. Thus, it can be seen that by priming the cavernosal nerve, the time delay between effective sfim~ tion and the onset of a response change may be decreased to about 1-2 seconds.
Yet another illustration of the err~cliv~,less of ylhnillg is shown in Figure 6. Figure 6 plots the results of one priming study from an experirnent on 7 dogs. It can be seen that at a starting t--mPscen~e of 0% (no y~ g), stim~ tion of the cavernosal nerve yields only a 4% percent change in t~mPscence (point A). However, when starting IllmP-scPnre is at 20%
(moderate plilllillg), a 22.5 % change in t~mlosc~nre is observed (point B) . Ata starting ~ scellce of 30%, a signifir~nt 32% change in tllm~scenre occurs (point C).
Taken together the graphs and plot of Figures 5 and 6 illustrate that after sufficiently stim~ ting the cavernosal nerve to elicit at least a partial t~lmPsc~n~e response, a measurable change in the fllm~scent response occurs more rapidly and on a larger m~gnil~l(le to subsequently applied stiml-ll-c pulses delivered to the nerve before the response fully recovers.
Priming of the cavernosal nerve may be accomplished with the array probe of the present invention or with a single stim~ tin~ electrode.
Regardless of the number of electrodes to be used, the priming method for the cavernosal nerve involves the step of applying a stim--lns to the nerve to evokea sub-m~xim~l tllm~scen~e of the penis such that subsequ~?nf tumescence responses to subsequently applied stimuli occur more rapidly.
For priming of the cavernosal nerve, the ground or l~r~lellce should be located near the mi-llin~ caudal to the stim--l~tion site (not laterally or to the side of the site). After grounding the patient, the operator places the probe of the device as previously described adjacent to the approximate location of the cavernosal nerve so that the array spans its possible locus.
S~t~inP~l (as opposed to pulsatile~ stimuli having an illlensi~y capable of evoking a sub-saturation criterion response are applied to the nerve via the array of the a~a~aLus. Stimuli of such an illL~l~iLy are applied to the nerve in accol.la"ce with the pre-de~med electrode sequence to evoke an initial tl~mescent response, which will expedite the onset of subseq~ent tnmpscent responses to subsequently applied stimuli. Following the priming step, the ,~sl,onse to effective stim~ ti~ n of the cavernosal nerve will occur more rapidly and on a larger m~gni1u~1~P.

The parameters for priming of the cavernosal nerve are preferably set ~ at 2-8 mA, 800 ~s, and 16Hz. Such parameters have been found to evoke a sub-saturation criterion response desirable for priming of the nerve.
Naturally, the parameters of the priming stimuli may be varied so long as the S ~ g stimuli are capable of evoking a sub-saturation response.
To prime the cavernosal nerve using a single electrode, the electrode is passed over the area believed to be the location of the target nerve, while .~imnltAn~ously applying stimnlll~ pulses of the above-described pArAm~t~rS.
The user continues to sweep the electrode over the target area until the nerve has been snfflriently primed.

Location of the Cavernosal Nerve After priming the cavernosal nerve (or in the case where priming is deem~d lmn~cessAry), the same may be located using the array probe of the present invention in accordance with the following method. The method for locating the cavernosal nerve generally co~ lises the steps of a) applying a stiml~ to the nerve to evoke a hlm~oscen~e response, b) detecting a ~lm~scence response to stimlll~tion of the nerve, c) ev~ln~ting the hlm~oscen~e response to stimlll~tion of the nerve, and d) autom~ti~lly modifying the site of subsequent stimlll~ti~n based on the evaluation of the hlm~scence response.
The method is unique in that the stimlllll~ is of a low inlelLsiLy known to stim~ te the nerve when the site of stim~ tion within 1-2 mm of the nerve.
The method is also unique due to the fact that the steps of evAlll~ting the response and modifying the site of stim~ tion are performed ~uLo~ "i~ir~lly by a control means.
To locate the nerve using the a~aldLus of the invention, the device is switched to the locating mode of operation. Upon initi~ting the locating mode, the electrode selecting algoriLIIlll of the control means hliLiaL~s a pre-arranged sequence among all or part of the electrode array. A pulsed stimlllns train is applied to the nerve in accordance with a pre-arranged electrode W O 96t39932 PCT~US~8~58 sequence. The parameters of the stim~ s train are set at an ill~ellsiLy known to stim~ t-p- the nerve when the stimnl~tin~ electrode is within 1.0 mm of the nerve. For loc~li7~tion of the cavernosal nerve, such parameters are set at 2~
mA, S00 ~s, 16 Hz. The stimuli to be applied to the nerve may be pulsed (as opposed to sust~inPd) as changes in the response pattern to pulsed stimuli (i. e., increases or decreases in penile hlm~scPn~e~) are easier to distinguish and hl~ t than changes in the re~onse pattern to sn~t~inP~l stimuli.
Changes in the response pattern are det~Pct~P~l and measured by the response measuring means of the apparatus. For location of the cavernosal nerve, the response m~c~lrin~ means is preferably a tnmPscenre monitor coll~lising mercury-filled distensible tubing. Naturally, any one of the other means described in this application for ~lPtecting and m~llring hlmP~cPnt~e of the penis is equally suitable for achieving the objectives of the present invention.
Response fee~lb~ck hlrolll,alion (that is, i"r "naLion collce~l~,g an increase or decrease in hlmPscence) is sent to the control means, where the control means in~ L~, the change in the f~lmPscent response in light of the stimnl~tion and response history of the cavernosal nerve. Based on the change in the response pattern, the control means dPte. ~ s which electrodes were most effective in stimlll~ting the cavernosal nerve and formlll~tPs and applies a second sequence of stimll1~ting pulses to the neNe by those electrodes found to be most effective. The program continues to run until the con~rol means identifiP~ which electrode is most effective at stim~ fin~ the nerve at an i"le~ily known to stimlll~tP~ the nerve at a ~ t~nre of 1 mm or less. At this stage in the method, the stimllllls pulse may be decreased to approximately 1-3 mA to confirm that the cavernosal nerve is indeed below the i~ntifi electrode.
By loc~li7ing the cavernosal nerve, the same can be spared during the excision of humorous tissue of the prostate. Following excision of tissue, the apparatus may be used again in the manner previously described to confirm that the cavernosal nerve has been spared and remains functional.

Although speci~lc parameters are listed above for both priming and loca~ing of the cavernosal nerve, the stiml-hls p~r~mPters may vary within the following ranges:
0.5-25 mA: Stim~ tit)n above 8 rnA h~ siLy ~ Ps spatial resolution while less current will make it easier to miss the effect altogether because the electrode will have to be right on the nerve for errecliv~ stimlll~fion to take place. At 4-8 rnA the electrode will activate the nerve from 1-2 m~n away.
200-2000 ~s: Durations of less than 200 ~s resulLt in individual pulse i.. ~ os which are too high. Longer durations add little nerve stiml-l~ting effect to each pulse.
4-50 Hz: Lower frequencies require a longer time period to activate the nerve response, while higher frequencies are associa~d with cl responses over the long term.

Alt~ live Embo.l;.. ~ and Appli~ n~

Alternative Electrode Configurations Although the electrodes of the array have been described as being spaced in a one ~limPn~ional or linear relationship, this is not to say that theelectrodes of the array may not be otherwise arranged. Tnr~ee-l, the electrodes 20of the array may be arranged in a non-linear (i.e., curved) arrangement or two(or multi) dimensionally as illustrated in Figure 7. Where the electrodes are arranged two dimensionally, they may be arranged in a grid-like formation.
In one aspect, this grid may be used to map the longitll~lin~l axis and symmetry of the target nerve. To map the axis of the nerve, a stimnl~tion 25method of successive triplets is applied. Using the successive triplet method,20-50 electrodes are arranged in a grid-like formation such that a cathode is ded on either side by an anode. The triplets of electrodes are then activated in accordance with a triplet selecting algolill~ to identify the longitll~l;n~l axis of the nerve. For reasons known to those skilled in the art 30of stim~ tin~ nerve axons, those triplets positioned orthogonal to the axis of W O 96/39932 PCT~US96/08858 the nerve will be less effective at stim~ ting the nerve than those triplets positioned in line with the axis.
The two-~limPn~ional, grid-like configuration is especially beneficial for optimal stim~ tion purposes (~ ccll~ecl below), as the electrode se1~cting algo.iLhl~l of the a~al~Lus is capable of locating the nerve (by ~wilCl~illg among the electrodes of the grid) to thereafter m~xim:llly stim~ te the nerve by combined stimlll~tion of the individual electrodes each capable of independently increasing or causing a response.

Nerve Lo~n~iz~7tion and Stimulalion for Therapeutic Purposes It is envisioned that the al)pandlus of the present invention may be used for ~lc~a~euLic purposes such as for the treatment of impotence. When stim--l~ting a nerve for a therapeutic purpose (either intraoperatively, tr~n~Cllt~n~ously~ transrectally or through an implant) the goal is to optimallystimlll~tr the nerve with a stimlll~l~ of the lowest possible inLellbiLy to avoid potential undesired effects such as patient pain, mllsclll~r twitches, urination, defecation, or toxicitv from ion deposition from the electrodes. The apparatus of the present invention is especially suited for this purpose in light of the fact that the apparatus is capable of autom~tir~lly locating and stimnl~tillg a nerveusing a single device coln~ illg small, closely-spaced electrodes activated at low stimlllll~ ies. The a~aldLus eli.,.i.. ~i~s reliance on the skill of the operator to enable precise location of nerves ~lifficult to see without a microscope (such as the cavernosal nerve). The apparatus of the device is also superior over prior stimlll~ting devices because it does not utilize cuff electrodes which tend to degenerate or deteriorate the nerve.
To optimally stim~ tr the cavernosal nerve using the device of Figure 1, probe 12 is first inserted within the rectum to locate the same. ~he nerve is located by the apparatus in accordance with the priming and/or locating methods previously described in this application. After locating the nerve, the electrodes closest to the nerve are repeatedly fired to optimally stimlll~te the CA 02223682 l997-l2-0~

W O 96/39932 PCT/U~/Q~8 nerve. If the opc.dtor wishes to stimnl~te the branches of the cavernosal nerve, multiple electrodes of the array may be activated in a rapid sequential manner to optimally stim~ ttq all branches of the nerve.
Rec~llse the array of the ap~aldLus utilizes small, closely spaced S electrodes, the a~alalus is capable of stiml-1:~ting the cavernosal nerve and any of its branches without c~ in~ the undesired effects described above, particularly that of pain. In fact, stim~ tion of the cavernosal nerve via the small-~ m~oter electrodes of the present invention is more effective (and efficient) than stim~ tion of the nerve by a larger electrode, as ~he current density of a low-hlL~l~iLy stim-~ c applied directly to the nerve by a small electrode is greater than the current density of the high-i~ sily stim~lns required to activate the nerve by a large electrode even at the same fli~t~n~e.
Although the probe shown in Figures 1-3 may be used to locate and optimally stim--l~t~ the cavernosal nerve (or any other nerve), a probe having an electrode array configured multi dimensionally may be used.
Alle~ dlively, the stimnl--c applying means of the a~palalus may be configured as an implant which may be surgically implanted within the body, adhesively applied to the skin, or inserted into a natural body cavity including, but not limited to, the rectum, vagina or urethra.
The implant in combination with the aukJlllaled control and response detection means of the present invention enables precise loc~li7~tion and optimal stimnl~tion of a nerve and any of its associated branches. Naturally, the implant should be capable of conforming to the tissue of the body or the body cavity into which it is inserted. An implant which may be inserted into a natural body cavity is shown in Figure 8. This implant takes the form of an exp~n~l~ble stent 60 provided with a plurality of electrodes 36. Stent 60 may be coupled to the a~alaLus of Figure 1 in place of probe 12 for the purpose of locating and optimally stim-~l~ting a nerve as previously described.
For the tr~n~c~t~n~ous stim~ tion of a nerve, it is envisioned that the electrode array may be configured as a patch which may be affLxed to the skin by a suitable adhesive. Akin to the probe of the appaldlus, the patch may be CA 02223682 1997-12-0~

W O 96/39932 ~CT~US96/08858 provided with an array of .stim~ tin~ electrodes positioned in a grid-like or other formation. T~ c~ ~ous sfim-ll~tion of a nerve is accomplished by first locating the nerve (via the patch) using the method previously described.
After locating the nerve, the electrode (or electrodes) found to be most S effective at stimlll~ting the nerve are activated to optimally stiml~l~te the nerve.
Naturally, the implant may take a form other than that suggested herein, the form of the implant being dependent upon the nerve to be located and its location within the tissues of the body.
An advantage of the implant embodiment of the present invention over prior implants is that the device takes into account shifts in tissue which may result in mic~lignmPnt of the target nerve with the electrodes of the array. In order to re-establish loc~li7~ti~n of the nerve, the o~e.~lor need only re-run the priming and locating steps of the a~aldlus to re-locate the nerve for optimal stim-ll~tion purposes. There is no need to remove the implant or reposition the same, in light of the fact that the array of electrodes is capable of s~imlll~ting the tissue of the body cavity at various sites.
It is also envisioned that the array probe may be used to identify and locate the severed end of a nerve so that r~tt~chm~nt of the nerve can be performed.

Alternative Means for Automatically Varying the Stimulation Site As stated previously in this application, one of the advantages of the present invention over the prior art is the provision of a lmeans for autom~tir~lly varying the site of stimlll~tion in response to information provided by the response detection means. Although the electrode array is well-suited to achieve the objectives of the present invention, other means for ?.~ltom~tir~lly varying the location of the stimlll~tion site have been envisioned.
One such device is a m~gn~ti-~ sphere which utilizes three m~n~tic induction coils which are positioned orthogonally with respect to each other to W O 96/39932 PCT~US96'/Q~58 m~gn~ti~.~lly induce a current in a specific site. The intlllcecl current may befocused as ~lirt~t~-l by the control means of the invention to apply a stimnlllsto a particular area for the purpose of activating and loç~li7.ing a target nerve.
A suitable m~gn-otir sphere is disclosed in U.S. Patent No. 4,905,698 to Clir-Strohl et al., the disclosure of which is incorporated herein by lefclellce. Them~gn~tic sphere of the Clir-Strohl et al. patent is cu~ llcl-;ially available from Navion, Stoughton, ~S~ ett~.
Yet another device for varying the site of stimnl~t;Qn is a single, small electrode movably positioned on a track. With lefelGllce to Figure 11, the site of stimnl~tion is altered by moving electrode 36 along a track 70 in accoldance with an electrode positioning algolilll,ll gove.lled by ~e control means of the hlvelllioll. By moving the electrode along the track, the exact location of the target nerve may be ~ kd by the method previously desclibed.
It should be lm~l~orstood that although not specifically described herein, other means capable of ~ltering the site of stimnl~tion are ~pl~,~liate for accomplishing the objectives of the present invention.
The foregoing description is considered to be illustrative of the principles of the present invention. It is not intended to limit the scope of the invention, as the same may be practiced otherwise than as specifically described herein. The scope of the invention is hereby defined by the following claims.

Claims (68)

What is Claimed:
1. An apparatus for stimulating and locating a nerve, comprising:
means for applying a stimulus to a nerve at a plurality of sites;
means for detecting a response to said stimulus; and means for automatically modifying the site of stimulation, said means for automatically modifying said site of stimulation including a means for interpreting the response provided by said response detecting means.
2. The apparatus of claim 1, wherein said means for applying a stimulus to a nerve applies said stimulus transcutaneously.
3. The apparatus of claim 1, wherein said means for applying a stimulus to a nerve applies said stimulus to a nerve exposed at an operative site.
4. The apparatus of claim 1, wherein said means for applying a stimulus to a nerve applies said stimulus to the nerve via a natural body orifice.
5. The apparatus of claim 1, wherein said means for applying a stimulus to a nerve is a magnetic induction device capable of focusing a magnetic field to induce an electrical stimulating current.
6. The apparatus of claim 1, wherein said means for applying a stimulus to a nerve is an array of electrodes.
7. The apparatus of claim 1, wherein said means for applying a stimulus to a nerve is a patch comprising an array of electrodes.
8. The apparatus of claim 1, wherein said means for applying a stimulus to a nerve comprises an electrode movably positioned on a track.
9. The apparatus of claim 6, wherein said electrodes are arranged in a multi-dimensional configuration.
10. The apparatus of claim 6, wherein said array includes 20-50 electrodes.
11. The apparatus of claim 6, wherein said electrodes are spaced 0.1-4.0 mm apart.
12. The apparatus of claim 1, wherein said stimulus comprises a train of multiple pulses.
13. The apparatus of claim 9, wherein said electrodes are activated in successive triplets to determine the longitudinal axis and symmetry of the nerve.
14. The apparatus of claim 1, wherein said interpreting means interprets data from said response detection means and wherein said interpreting means discriminates between states corresponding to periods of successful stimulation and states corresponding to unsuccessful stimulation of the nerve.
15. The apparatus of claim 1, wherein said modifying means is a microprocessor.
16. The apparatus of claim 1, wherein said modifying means modifies the application of stimuli by said stimulus applying means in accordance with an electrode selecting algorithm.
17. The apparatus of claim 1, wherein said stimulus applying means is a probe used intraoperatively.
18. The apparatus of claim 1, wherein said means for detecting a response to a stimulus is an ultrasonic density gauge.
19. An apparatus for stimulating and locating the cavernosal nerve, comprising:
a probe having a handle portion and a stimulating tip for applying a stimulus to a nerve, said stimulating tip comprising an array of electrodes;
a control means for governing activation of said array of electrodes, said array of electrodes being activated in accordance with an electrode selecting algorithm which evaluates a tumescence response to successful stimulation of the cavernosal nerve; and a response detection means for detecting and measuring a tumescence response, said response detection means providing response feedback information to said control means for evaluation by said electrode selecting algorithm.
20. The apparatus of claim 19, wherein said stimulus a train of pulses.
21. The apparatus of claim 19, wherein said electrodes are spaced 1.0 mm apart.
22. The apparatus of claim 19, wherein said array of electrodes conmprises 4-16 electrodes.
23. The apparatus of claim 19, wherein said response detection means is a tumescence monitor comprising distensible tubing filled with a conductive fluid.
24. The apparatus of claim 19, wherein the parameters of said stimulus range between 0.5-25 mA, 100-2000 ,us, 4-50 Hz.
25. The apparatus of claim 19, wherein said control means evaluates the change in the tumescence response.
26. The apparatus of claim 25, further comprising a filter to isolate the change in the tumescence response from changes induced by other aspects of the locating procedure.
27. The apparatus of claim 19, wherein the most distal electrode of said array is angled at approximately 45° to position said electrode below theprostate gland or urethra of a patient.
28. The apparatus of claim 19, wherein said handle of said probe is flexible to enable positioning of the probe within the body tissue.
29. The apparatus of claim 19, wherein said apparatus further includes a means for indicating the location of the nerve to the user.
30. An apparatus for locating and optimally stimulating a nerve, comprising:
an implant comprising an array of electrodes for delivering a stimulus to a nerve;
a control means for governing activation of said electrodes of said array, said array of electrodes being activated in accordance with an electrode selecting algorithm which evaluates a response to successful stimulation of the nerve; and a response detection means for detecting and measuring a response, said response detection means providing response feedback information to said control means for evaluation by said electrode selecting algorithm.
31. The apparatus of claim 30, wherein said electrodes are positioned in a multi-dimensional formation.
32. The apparatus of claim 30, wherein said electrodes are spaced 0.1-4.0 mm apart.
33. The apparatus of claim 30, wherein a selected subset of said electrodes are determined to be near the nerve and are activated in rapid sequence to optimally stimulate the nerve.
34. The apparatus of claim 30, wherein said nerve is the cavernosal nerve.
35. The apparatus of claim 30, wherein said implant is a stent inserted within a natural body cavity of the patient.
36. The apparatus of claim 34, wherein said response detection means is a tumescence monitor.
37. A method for stimulating the cavernosal nerve to facilitate localization thereof comprising the step of:
applying a stimulus, said stimulus being capable of initiating sub-maximal tumescence of the penis such that subsequent tumescence responses to subsequently applied stimuli occur with shorter delay from the onset of successful stimulation.
38. The method of claim 37, wherein said stimulus is a train of electrical pulses.
39. The method of claim 38, wherein the parameters of said stimulus are within the range of 0.5-25 mA, 100-2000 µs, 4-50 Hz.
40. The method of claim 38, wherein said stimulus is applied to the nerve by a probe having an array of electrodes.
41. The method of claim 40, wherein said array comprises 4-16 electrodes.
42. The method of claim 37, wherein said stimulus is a drug capable of evoking a tumescence response.
43. The method of claim 42, wherein said drug is papaverine.
44. The method of claim 37, wherein said stimulus is a vibrating pulse.
45. A method for stimulating and locating the cavernosal nerve, comprising the steps of:
(a) applying a stimulus to the nerve to evoke a tumescence response, said stimulus having an intensity known to stimulate the nerve when said site of stimulation is within a known distance from the nerve;
(b) detecting a tumescence response to stimulation of said nerve;
(c) evaluating the tumescence response to stimulation of said nerve;
and (d) automatically modifying the site of subsequent stimulation based on the evaluation of the tumescence response.
46. The method of claim 45, wherein said stimulus is of an intensity known to stimulate the cavernosal nerve when said site of stimulation is within 1 mm of the nerve.
47. The method of claim 45, wherein steps (a)-(d) are repeated until localization of the nerve is achieved.
48. The method of claim 47 further comprising the step of indicating to the user the location of the nerve.
49. The method of claim 45, wherein said stimulus is applied to said nerve by a probe having an array of electrodes.
50. The method of claim 45, wherein said stimulus is applied to said nerve by an implant having an array of electrodes positioned in a multi-dimensional arrangement.
51. The method of claim 50, wherein said electrodes of said implant are activated in successive triplets to determine the longitudinal axis of the nerveto optimally stimulate the nerve.
52. The method of claim 45, wherein the stimulus comprises a current pulse of 0.5-25 mA.
53. The method of claim 45, wherein said stimulus is a train of pulses.
54. The method of claim 45, wherein said response to successful stimulation of the cavernosal nerve is detected by a tumescence monitor.
55. The method of claim 54, wherein the change in the tumescence response is evaluated by a response interpreting means.
56. The method of claim 49, wherein said site of stimulation is automatically modified among the electrodes of the array in accordance with an electrode selecting algorithm.
57. A method for locating a nerve, comprising the steps of:
(a) applying a stimulus to a nerve;
(b) detecting a response to stimulation of the nerve;
(c) evaluating the response to successful stimulation of the nerve; and (d) automatically modifying the site of stimulation based on the evaluation of the response.
58. The method of claim 57, wherein said stimulus is of an intensity known to stimulate the nerve when the site of stimulation is within a known distance from the nerve.
59. The method of claim 57, wherein said steps (a)-(d) are repeated.
60. The method of claim 59, further comprising the step of indicating to the user the location of the nerve.
61. The method of claim 57, wherein said stimulus is applied to the nerve by am instrument including an array of electrodes.
62. The method of claim 57, wherein said site of stimulation is modified in accordance with a site selecting algorithm which is based on information provided by a response detecting means and stimulation input means.
63. The apparatus of claim 19 further comprising a suction port for the removal of bodily fluids from the surgical field.
64. An apparatus for locating a nerve, comprising:
a source of electricity;
a stimulus applying means coupled to said source of electricity, said stimulus applying means including an array of electrodes and a means for varying activation of said electrodes of said array; and means for detecting a response to said stimulus.
65. A method for stimulating and locating a nerve, comprising the steps of:
(a) applying a low intensity stimulus to the nerve to evoke a sub-maximal tumescence response, said stimulus having an intensity known to stimulate the nerve when said site of stimulation is within a minimal distance from said nerve;
(b) detecting a tumescence response to stimulation of said nerve;
(c) evaluating the differential of the tumescence response to stimulation of said nerve;
(d) automatically modifying the site of subsequent stimulation based on the evaluation of the differential of the tumescence response.
66. The method of claim 45, wherein steps (a)-(d) are repeated until localization of the nerve is achieved.
67. The method of claim 66, further comprising the step of indicating to the user the location of the nerve.
68. The method of claim 65, wherein said stimulus is applied to said nerve by an array of electrodes, each electrode of said array having a diameter less than 2 mm.
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