An adaptive tourniquet for improved safety in surgery.
Transcription
An adaptive tourniquet for improved safety in surgery.
122 NO.2, IEEE TRANSACTIONS ON BIOMEDICAL ENGINEERING, VOL. BME-29, NO. 2, FEBRUARY 1982 Regular Papers An Improved Safety in Surgery An Adaptive Tourniquet Tourniquet for Improved McEWEN, MEMBER, IEEE, AND ROBERT W. MCGRAW McGRAW JAMES A. MCEWEN, AfJstract-The increasingly of the Abstract-The increasingly recognized recognized inability inability of the current genpneumatic tourniquets pressure with with adequate eration control pressure eration of of pneumatic tourniquets to to control adequate accuracy, and stability has been been associated associated with continuing accuracy, reliability, reliability, and stability has with continuing reports of of tourniquet-related incidents, and Moreover, and hazards. hazards. Moreover, reports tourniquet-related injuries, injuries, incidents, the labor-intensiveness and operating costs with the the use of and operating the labor-intensiveness costs associated associated with of pneumatic tourniquets tourniquets have have significant significant cost implicacurrent types of of pneumatic implications for for hospitals. hospitals. To large extent, the the recent development To a large of a tions development of microprocessor-based tourniquet tourniquet capable and accurately of safely mainmicroprocessor-based capable of safely and accurately maintaining and capable capable of simultaneously performing performing of simultaneously desired pressure, and taining a desired other of alarm conditions, has as detection alarm conditions, has reduced reduced other functions functions such such as detection of these hazards hazards and and operating-cost implications. Furthermore, availthe availthese operating-cost implications. Furthermore, the ability of microprocessor-based tourniquet has facilitated facilitated the the developof a microprocessor-based ability tourniquet has development of the adaptive adaptive tourniquet in this this paper, paper, in in which which the the described in ment of the tourniquet described changed throughout procedure in aa tourniquet cuff is is changed pressure in tourniquet cuff throughout aa surgical surgical procedure as function of of the patient's changing changing intraoperative as a function the patient's intraoperative systolic systolic pressure, thus approximating the the minimum maintain minimum safe safe pressure necessary to maintain thus approximating aa bloodless bloodless field for surgery. While the of an adaptive tourniquet, tourniquet, an adaptive field for surgery. While the use of rather than just just a microprocessor-based microprocessor-based tourniquet rather than set at aa constant tourniquet set pressure may be necessary in most most cases, cases, it it promises promises to to have have signifipressure may not not be necessary in signififor patients cant in certain certain surgical surgical procedures procedures and patients who who may be and for cant value value in may be of tourniquet-induced tourniquet-induced complications. complications. Also, the lower lower at greater risk risk of Also, the average possible through through the the use of of an adaptive average pressures possible adaptive tourniquet tourniquet surgical techniques techniques of longer duration permit the the evolution of surgical of longer duration may permit evolution of in the without concomitant increase the risk toumiquet-induced increase in risk of of tourniquet-induced without aa concomitant complications. despite the increased safety the increased of the the adaptive complications. Finally, Finally, despite adaptive safety of the operating tourniquet, be lower estimated that lower than that the than tourniquet, itit isis estimated operating costs will be for conventional conventional pneumatic pneumatic tourniquets tourniquets due elimination of the need need due to elimination of the for for labor-intensiveness. for compressed gas and reduced reduced labor-intensiveness. INTRODUCTION INTRODUCTION URRENTLY available available types of of surgical CURRENTLY surgical tourniquets tourniquets consist of basic components: a source of of pressurized of three three basic _,sist pressurized gas, pressure-regulating mechanism with pressure gauge, and mechanism with and gas, a pressure-regulating the of is applied to the proximal portion pneumatic cuff which is cuff which a pneumatic applied proximal portion of patient's limb limb and inflated to a suprasystolic in a patient's and inflated suprasystolic pressure pressure in order maintain a bloodless bloodless surgical field in in the portion the distal order to to maintain distal portion surgical field of the limb. properly employing employing a pneumatic pneumatic tourniquet of the In properly limb. In tourniquet the cuff the pressure should for surgery surgery of of the extremities, the pressure in in the cuff should for the extremities, to assure a be maintained maintained at the the minimum minimum pressure necessary be necessary to bloodless field field distal the cuff. cuff. Maintaining bloodless field field bloodless distal to the Maintaining aa bloodless in the the limb easier, surgical techfor surgery makes dissection dissection easier, in limb for surgery makes surgical tech- C 1981. This received June revised October Manuscript received June 3, 3, 1981; October 6, This Manuscript 1981; revised 6, 1981. British Columbia Care ReHealth Care ReColumbia Health work was supported supported in part by the British Grant 94 94 (80-3). search Foundation Foundation under under Grant (80-3). search the Department of Biomedical Biomedical Engineering, with the Department of J. A. McEwen J. McEwen is is with Engineering, V5Z IM9. 1M9. Vancouver, B.C., Canada vsz Vancouver General General Hospital, Hospital, Vancouver, B.C., Canada R. Division of R. W. W. McGraw is the Division of Orthopaedic is with with the Orthopaedic Surgery, Surgery, UniverCanada V5Z 1M9. sity of British British Columbia, Columbia, Vancouver, B.C., Canada V5Z IM9. sity of Vancouver, B.C., niques less and the required for niques less traumatic, traumatic, and the time time required for operations operations shorter [1]. shorter maintaining aa bloodless bloodless field field while [1]. Moreover, Moreover, maintaining while Simultaneously minimizing the pressure in the pneumatic pneumatic the pressure simultaneously minimizing in the tourniquet cuff will minimize minimize the the probability probability of cuff will of pressurepressuretourniquet related injury injury associated [2], [3]. [3] . related associated with with tourniquet tourniquet usage usage [2], Because its usefulness, usefulness, the pneumatic tourniquet widely Because of of its the pneumatic tourniquet isis widely employed. Information Information obtained obtained from and employed. from manufacturers manufacturers and regulatory suggests that America at at least least ten ten regulatory agencies agencies suggests that in in North North America thousand pneumatic pneumatic tourniquets tourniquets are in more more than than one one are used used in thousand million procedures annually. However, none of these million surgical none of these surgical procedures annually. However, pneumatic tourniquets tourniquets are are capable capable of of safely and automatically pneumatic safely and automatically maintaining the minimum minimum pressure pressure necessary necessary to to assure bloodmaintaining the assure aa bloodless field field throughout due to with to factors factors associated associated with less throughout surgery surgery due their design and and construction construction (e.g., -[7]) and they cantheir design (e.g., see see [4] ) and they can-[7] [41 modified readily readily to levels not be be modified to achieve achieve Significantly significantly greater greater levels of reliability. Accordingly, of safety, and reliability. safety, accuracy, accuracy, stability, stability, and Accordingly, itit isis not surprising the widespread use of perhaps not of pneumatic pneumatic perhaps surprising that that the widespread use tourniquets has been accompanied continuing reports reports of tourniquets has been accompanied by by continuing of injuries, e.g., has been that It has been suggested injuries, e.g., [4]-[6], [4] -[6], [8]-[11]. [8] -[11]. It suggested that the true incidence of tourniquet-induced tourniquet-induced complications complications may the true incidence of may be significantly underestimated, and each use use of pneube that each of aa pneusignificantly underestimated, and that matic although matic tourniquet tourniquet may may in in fact fact lead lead to to some some damage, damage, although such damage is generally short-term and reversible reversible [11], such damage is generally short-term and [11], [12]. [12]. Many, but all, tourniquet-related tourniquet-related injuries are pressurepressurebut not not all, Many, injuries are related. Tourniquet-related complications may result result not not only only related. Tourniquet-related complications may from excessive pressure to nerve nerve compression or other other from excessive pressure leading leading to compression or injuries at the site the cuff cuff [2], but also also at the site of of the injuries [2], [13], [13], [14], [14], [16], [16], but from insufficient from to surgical insufficient pressure leading leading to surgical complications, complications, passive congestion, and hemorrhagic hemorrhagic nerve infiltration infiltration [14], [14], passive congestion, and from excessive periods from excessive of tourniquet periods of tourniquet application application [9], [9], [15], [15], [16], application of of the or from the cuff from application without due due consideraconsideracuff without [16], or tion of the the underlying underlying anatomy anatomy [11], tion of To aa large [ I 1], [17], [ 17], [18]. [18]. To large the risk extent, the risk of of injury associated with these factors has with these factors has extent, injury associated been significantly reduced by by the the recent recent development development of of aa been significantly reduced microprocessor-based having aa much higher degree much higher microprocessor-based tourniquet tourniquet having degree of safety, of the of and reliability objective of The objective the safety, accuracy, accuracy, and reliability [4]. [4]. The work described paper was work was to to determine whether the the in this this paper determine whether described in already tourniquet could be could be already developed developed microprocessor-based microprocessor-based tourniquet modified and used effectively effectively to to further reduce the the probability further reduce probability modified and used of injury in the of adjusting the the pressure pressure in the tourniquet tourniquet injury by by adaptively adaptively adjusting cuff intraoperatively, the patient's patient's changing changing of the cuff as a function function of intraoperatively, as in order to minimize systolic pressure, in minimize the pressure necessary order to the pressure systolic pressure, necessary to maintain aa bloodless bloodless field during surgery. to maintain field during surgery. 0018-9294/82/0200·0122$00.75 0018-9294/82/0200-0122$00.75 © 1982 © IEEE 1982 IEEE Authorized licensed use limited to: The University of British Columbia Library. Downloaded on April 21, 2009 at 14:19 from IEEE Xplore. Restrictions apply. 123 123 MC EWEN EWEN AND AND MC GRAW: TOURNIQUET TOURNIQUET FOR IMPROVED SAFETY FOR IMPROVED SAFETY IN IN SURGERY SURGERY MC GRAW: MC ADAPTIVE ADAPTIVE TOURNIQUET TOURNIQUET At At present, present, pressures pressures in in pneumatic pneumatic tourniquets tourniquets are are commonly commonly set constant, preestablished preestablished levels: pressures at constant, for example, set at levels: for example, pressures of approximately mmHg for for upper upper limbs of 300 mmHg and 500 500 mmHg limbs and approximately 300 mmHg for lower lower limbs limbs are are widely widely employed employed [1], for pres· (1], [13]. Such pres[131. Such sures are are clearly clearly much higher than than normal normal systolic pressures, sures much higher systolic pressures, but used traditionally but have have been been used traditionally to to accommodate hysteresis accommodate hysteresis in pressure-regulating pressure-regulating mechanisms, mechanisms, errors errors in pressure gauges, gauges, in in pressure suboptimal cuff geometries, leaks, leaks, and cuff geometries, and intraoperative suboptimal intraoperative increases increases It has in systolic pressure. It in has been been suggested that improved systolic pressure. suggested that improved safety safety would result result from from setting pressure P would to some some setting tourniquet tourniquet pressure PTT to threshold K K above constant threshold above aa patient's patient's preoperative preoperative systolic constant systolic pressure some arbitrary Ps(to), rather rather than to some unnecespressure Ps(to), than to arbitrary and and unnecessarily high level level [2] i.e., sarily high (2],, i.e., = Ps (to) + PT =Ps(to) + K. PT (1) (1) It been suggested that 30-75 mmHg might be It has has been suggested specifically specifically that 30-75 mmHg might be K for appropriate of K for upper upper limbs and appropriate values values of limbs [2], [3], [9], [91, and [2], [3], that K that K might might be be set set to to PS(to) Ps(to) for for lower lower limbs, provided the the limbs, provided patient was was normotensive did not have grossly not have normotensive and and did patient grossly hyperhypertrophied or obese thighs thighs [19]. or obese the above-noted trophied above-noted However, the (191. However, limitations the accuracy accuracy and and reliability of widely widely used types limitations in in the used types reliability of of pneumatic their use either hazardous of pneumatic tourniquets makes their use either hazardous or tourniquets makes or labor-intensive because constant monitoring would needed. constant monitoring labor-intensive because would be be needed. In contrast, the lower lower pressures pressures which which have In been advocated have been advocated contrast, the have been been implementedimplemented through the use use of the previously have of the through the previously mentioned microprocessor-based microprocessor-based tourniquet, resulting in in reducreducmentioned tourniquet, resulting tions in in tourniquet tourniquet pressure pressure by by as much as as 40 40 percent percent in tions as much in comcomparison to to traditional levels, with with aa simultaneous reduction in traditional levels, simultaneous reduction in panson labor-intensiveness and labor-intensiveness and increased minimum increased safety safety [4] Thus, aa minimum [4] .. Thus, constant pressure ,can be achieved use of achieved through the use of such constant pressure can be such aa through the In certain device. In certain cases, however, aa dynamically device. cases, however, dynamically changing changing pressure in in the the tourniquet cuff may may be warranted to to further be warranted further pressure tourniquet cuff reduce the pressure and and thereby thereby increase increase safety for cercerthe mean mean pressure reduce safety for tain patients patients at risk of tourniquet-induced complicaat greater of tourniquet-induced tain greater risk complications, e.g., e.g., those who have have thin thin'limbs protective limbs with little protective those who with little tions, musculature such as infants, infants, small children, and and certain adults. musculature small children, such as certain adults. Particularly these patients and perhaps Particularly for for these, patients and perhaps for for others, others, aa tourtourniquet capable capable of minimizing its cuff pressure of adaptively niquet adaptively minimizing its cuff pressure throughout procedure promises promises to to be be safer than one one throughout aa surgical surgical procedure safer than which only capable is only capable of pressure. which is of maintaining maintaining aa constant constant pressure. Because the the patient's patient's systolic pressure Ps Because Ps can vary throughthroughsystolic pressure can vary out the out the time time tt of surgical procedure as aa function of aa surgical procedure as variables function of of variables such as as changes in anesthetic such anesthetic technique or physiologic physiologic' status, changes in technique or status, tourniquet pressure PT PT should also be be aa time-varying should also tourniquet pressure time-varying function function in order to minimize the in order to minimize the pressure pressure necessary necessary to to maintain maintain aa bloodless and (1) be expressed expressed as as bloodless field field and (1) should should be = PS (t) + +K PT(t) =Ps(t) K. PT(t) (2) (2) the threshold in (2) Also, should be be set Also, the threshold K K in (2) should set according according to to other other variables, i.e., variables, i.e., The patient's true pressure Ps Ps(t) related to to the the true systolic The patient's systolic pressure (t) isis related measured pressure PSM(t) PSM(t) as determined by by an as determined an indirect measured systolic indirect systolic pressure oscillometry or Korotkoff-sound analysis analysis in in method such method such as as oscillometry or Korotkoff-sound the following following manner: manner: the (4) .(4) Ps(t) 1M .- PSM PSM(t) (t) ++ ep (t) ==fM Ps ep where fM = fM(WM, CM, gM) (5) (5) of the the pneumatic and width of pneumatic cuff cuff used used for for and where where wM the width WM isis the of blood pressure blood CM isis the the the circumference of the pressure measurement, measurement, cM circumference limb, gM the anatomy, associated with with the anatomy, geometry, geometry, limb, factor associated gm isis aa factor and shape of the is measured, at which which blood blood pressure pressure is and shape of the limb limb site site at measured, and ep error associated with the the indirect indirect measurement measurement and associated with some error ep isis some technique - [24] . technique [20] [201-[24]. If set at at (N If tourniquet pressure is is set discrete times {tt} , tourniquet pressure (N++ 1) 1) discrete times {tj}, i = 0, procedure rather continuously, than continuously, i= rather than 1, ... *-* ,, N, during aa procedure 0, 1, N, during then (2) becomes becomes then (2) PT(t)=PS(ti)+K+eA(t-tj) (6) (6) PT(t) =Ps(ti) + K+ eA(t - ti) titi<t~tj+l < t 6 ti+1 where eA eA represents the maximum in the patient's maximum increase where increase in the patient's represents the systolic pressure which may have have arisen which may arisen since since the the last last measuresystolic pressure ment because of of changes patient's cardiovascular cardiovascular status status the patient's ment because in the changes in or for other reasons. Combining (4) (4) and or and (6) for other reasons. Combining (6) yields yields +e PT(t) = 1M .-PSM(ti) PsM(tj) + PT(t) =fM (7) (7) where e =fT + ep + eH + es + eA(t - ti) (8) (8) for for i= O~ , -N. , ti < t<ti+ To of short-term in tourniquet tourniquet To reduce short-term changes the magnitude reduce the magnitude of changes in pressure as of the in successive the variability successive determidetermifunction of pressure as aa function variability in nations , moving average value could be employed, be a value could of PPSM, nations of moving average employed, SM e.g., aa three-point e.g., three-point moving moving average average PSM = 3 E PSM(ti-3+f) j=I (9) (9) could be substituted for PS in (7). substituted for could be PSM (7). M in As an example the application of (7) As an of the one might example of application of (7) above, above, one might consider the case consider the indirect determination of blood case where where indirect determination of blood prespressure being performed sure isis being on one one upper limb by some system performed on upper limb by some system the requirements of the the draft draft AAMI AAMI standards meeting the meeting requirements of standards [23][23] [24], and where where such information isis used to manually [24], and such information used to reset manually reset the pressure in aa commercially the pressure in tourniquet commercially available available pneumatic pneumatic tourniquet the other applied to the other upper at intervals of 30 applied to upper limb limb at intervals of 30 min or more. more. min or In such to 16 In 16 mmHg such aa case, should be be adequate for case, setting setting ep mmHg should adequate for ep to of PPSM values of values within two standard deviations of PPs. two standard deviations of Other SM within s . Other typical values are are typical values IM= fm = 11 K = eH + eS +fT(WT, CTgT) (3) (3) fr== 10 10 mmHg fT mmHg where is inherent error due where eH eH is inherent error due to to hysteresis the pressurehysteresis in in the pressure= 20mmHg 20 mmHg regulating the pressure-sensing regulating mechanism, mechanism, es in the the error error in pressure-sensing es es isis the es = means, and and fT is aa function fr is function of of tourniquet cuff width limb means, tourniquet cuff width wT, WT, limb 50 mmHg eeA(30 A (30 min) min) == 50 mmHg circumference and considerations considerations related circumference CT, to the the shape related to and shape and CT, and geometry the limb gT [9], of the and assuming and cuff cuff gT geometry of limb and [11], [17], [17], [18], 50 mmHg, [18], [20]. assuming eH only 50 (7) becomes mmHg, (7) becomes (91, [11], eH isis only [20] . and Authorized licensed use limited to: The University of British Columbia Library. Downloaded on April 21, 2009 at 14:19 from IEEE Xplore. Restrictions apply. IEEE TRANSACTIONS TRANSACTIONS ON ON BIOMEDICAL BIOMEDICAL ENGINEERING, ENGINEERING, VOL. VOL. BME-29, BME-29, NO. NO.2, FEBRUARY 1982 1982 IEEE 2, FEBRUARY 124 124 PT(t) ==PSM(ti) PSM(tj) ++ 146 146 mmHg mmHg PT(t) . ti+ < tt" ti+ I1 tjtj < = 0,1 ,N. ii=O,I,···,N. (10) (10) Thus, in this this example, example, tourniquet tourniquet pressure pressure should be set at 146 mmHg above patient's intraoperative systolic pressure the above patient's intraoperative systolic 146 for safe safe operation. operation. In practice, practice, this threshold might be much larger, e.g., typical typical values of 150 ISO mmHg mmHg for eH eH have been be desirable desirable in [7]. Therefore, although it might might be reported [71. lower pressures of of as little little as 30-75 30-75 principle to use suggested lower [2], [3], [3], [9], [9], preoperative systolic level level [2], mmHg above the preoperative such suggestions with with commonly commonly used used implementation of such hazardous_ tourniquets would be hazardous. previously mentioned mentioned microproThe projected use of the previously the above above example example is instructive. cessor-based tourniquet in the adaptively set on could be adaptively Assuming that tourniquet pressure could of systolic systolic blood blood presthe basis of automatic determinations of I-min intervals, the equivalent values for (8) (8) sure made at 1-min would be as follows: IT== 10 lOmmHg mmHg fT ep = 16 ep 16 mmHg eH = =6mmHg 6 mmHg eH es == 3 mmHg mmHg es eA(1 min) == 15 IS mmHg eA(l min) and (7) would become + 50 mmHg, PT(t) == PSM PSM(tj) mmHg, (ti) + PT(t) ti < t < ti+ 1 i=O,I,···N, i = 0, 1 , * N. (11) 11 resulting in considerably lower pressure in the tourniquet cuff. tourniquet cuff. For nonstandard employing a nonstandard For blood pressure measurements employing system, cuff, or anatomical location, be a function function would be location, 1M fM would of the variables indicated in (5) rather than a constant. Similarly, IT variables, as fT is generally a function of corresponding variables, suggested by (3). DESCRIPTION SYSTEM DESCRIPTION OF OF SYSTEM Fig. I1 shows of the the tourof the the prototype of diagram of block diagram shows a block niquet which was initially developed in order to determine determine whether it would be possible to adaptively tourniquet adjust tourniquet adaptively adjust pressure as a function of intraoperative systolic With systolic pressure. With the exception of the pressure-measuring module, printer, and blood pressure cuff depicted in Fig. I, 1, all components are similar to those in the prototype of the microprocessor-based microprocessor-based tourniquet described previously The micromicroelsewhere [4]. [4]. The previously elsewhere computer employs an Intel 8085A microprocessor with 2K byte byte RAM and 8K byte PROM. The hardware was based on an STD bus with card cage and PROLOG 780 7801I CPU board, board, PROLOG 7000 motherboard. TTL I/O 7604 TTL PROLOG 7604 board, I/O board, motherboard, PROLOG custom analog I/O board, and power-supply As sugpower-supply board. As gested by Fig. I, 1, pressure in the cuff is controlled by a combination of pressure-generating element and and pressure-release pressure-release pressure-generating element valve. The pressure-generating element is an electrical electrical pump with appropriate control circuitry limit and modifications modifications to limit circuitry and the maximum pressure to 500 mmHg. Data obtained from obtained from the pressure transducer/processor in the the regulation regulation used in. transducer/processor are used of pressure in the cuff to within ±± 6 mmHg. The regulation of of The regulation mmHg. ALPHANUMERIC PRINTER ADAPTIVE ALARMS! CONTROLS n :~ PERIODIC ~NON-INVASIVEI SYSTOLIC PRESSURE MEASUREMENT II II PRESSURE GENERATING ELEMENT PRESSURE RelEASE VALVE t J 't;J :' UFF TOURN UF B PRESSURE TRANSOUCER! ~ROCESSOII .1. MEMORY MICROPROCESSOR ~8D85A; : ~ ~ USER USER ALARMS! ALARMS! CUFF CUFF CONTROL CONTROL PANEL PANEL INDICATORS INDICATORS STATUS STATUS PRESSURE t DISPLAY DISPLAY 12K PROM 21< RAM t ELAPSED ELAPSED E TIME TIM. DISPLAY DISPLAY : tourniquet. 1. Block diagram of the prototype of the adaptive tourniquet. Fig. 1. pressure thus thus achieved achieved is is an an order order of of magnitude magnitude better better than than pressure used at that of pneumatic that of pneumatic tourniquets tourniquets which which are are widely widely used at present. present. not only only perelement not Use Use of pressure-generating element perof an an electrical electrical pressure-generating operating also reduces of pressure, mits better control control of mits better pressure, but but also reduces operating conventional tourcosts eliminating the costs by by eliminating the requirement requirement of of conventional tourniquets for for compressed gas. compressed gas. niquets the tourcontrol/display panel of the The configuration of The configuration the control/display panel of of the tourconThe panel panel conFig. 2. 2. The seen in in Fig. niquet in Fig. can be be seen Fig. I1 can depicted in niquet depicted of cuff cuff period of the period to indicate indicate the tains an an elapsed-time display to tains elapsed-time display of variety of to indicate and aa variety cuff pressure, pressure, and inflation, indicate cuff display to inflation, aa display as such as of hazardous conditions such hazardous conditions audiovisual alarms to to warn warn of audiovisual alarms of periods of excessive periods underpressurization, excessive overpressurization, underpressurization, overpressurization, malfunctions internal malfunctions lines, and and internal of the the cuff cuff lines, kinking of inflation, kinking inflation, the also shows shows the of aa pressure Fig. 22 also transducer. Fig. such such as as failur~ failure of pressure transducer. protoin the the protoemployed in alphanumeric and the the device device employed printer and alphanumeric printer This type for periodically pressure PPSM. measuring systolic systolic pressure periodically measuring type for SM . This Model 845 845 nonnonpressure-measuring was aa DINAMAP DINAMAP Model device was pressure-measuring device presestimates systolic systolic presinvasive invasive blood blood pressure monitor which which estimates pressure monitor of an Controls an oscillometriC [25]. Controls sure sure by means of oscillometric algorithm algorithm [25]. by means of were set set so so that that values values of on the the pressure-measuring device were on pressure-measuring device The intervals. The at I-min be generated PS would normally 1-min intervals. PSM normally be generated at M would DINAMAP Model Model 950 950 printer, which printer, which printer was aa DINAMAP employed was printer employed and which which device and is compatible the pressure-measuring with the pressure-measuring device is compatible with connector. can system connector. can accept other serial serial input through aa system input through accept other was fabricated fabricated tourniquet was the adaptive adaptive tourniquet The prototype of the The prototype of and from from device and from the the conventional pressure-measuring device from conventional pressure-measuring by tourniquet by the previously described microprocessor-based microprocessor-based tourniquet the previously described MICRO/SYS of three hardware. First, First, aa MICRO/SYS means of three basic changes in in hardware. basic changes means STD the card card cage and STD cage and dual serial serial interface card was was added added to to the dual interface card from was removed the and an EIA-to-TTL chip converter chip was removed from the bus; bus; and an EIA-to-TTL converter data for the printer. serial to levels board to generate compatible data levels for the printer. generate compatible serial board in Fig. as depicted cables and cables auxiliary connectors connectors and Fig. I,1, auxiliary depicted in Second, Second, as to connect line between between pressurewere installed installed to the serial serial line pressureconnect the were the serial board of of the the tourtourand printer to the serial board device and measuring printer to measuring device of softthe development of softas well; this change permitted the development niquet well; this change permitted niquet as to in the, data being ware in the the tourniquet scan the, alphanumeric alphanumeric data being ware tourniquet to scan to easily extract successive deterto the in order order to successive deterthe printer easily extract passed printer in passed to The third hardof the the patient's third hardminations minations of pressure. The systolic pressure. patient's systolic the of an extra and of control ware consisted of the provision of an extra control and ware change consisted provision change in to the can be seen operdisplay panel, which can be seen in Fig. 2, to permit the operwhich Fig. 2, permit display panel, Authorized licensed use limited to: The University of British Columbia Library. Downloaded on April 21, 2009 at 14:19 from IEEE Xplore. Restrictions apply. EWEN AND AND MC FOR IMPROVED IMPROVED SAFETY SAFETY IN MC MC EWEN MC GRAW: GRAW: TOURNIQUET SURGERY IN SURGERY TOURNIQUET FOR 125 125 (a) (a) 300 ............ ..(.:..... .. ~~.~~~~.;;~~.~; .~~~.~~~;:~ ..;~~;~;~.~~; ... . 300 Conventional pneumatic tourniquet (b) (b) (b) ~Ecm , t Microprocessor-based Microprocessor·based ~ ..,.................. "''''... ''.'''''' ~ s~ ~~~~~~~~~~~ (tourniquet ~ :........ .................. -: _ tourniquet ~ 200 ..§.E ,,,,,,,,,.7 P ~·-·-··---T~~.~.~~:==:. g .~~.~~.~.~~~.~~~~~~.~~~.~~~.T~~~·~;·;~·;·~---~::........... ....... ................. T01 T rue systolic True systolic pressure pressure Ps 1001 Fig. 2. 2. Physical Physical configuration of the the prototype of the configuration of Fig. the adaptive prototype of adaptive tournitourniin which which the quet in the printer, noninvasive pressure-measuring printer, noninvasive quet pressure-measuring module, and module, and as well well as cuff, as as microprocessor-based and cuff, microprocessor-based tourniquet cuff, can be be seen. tourniquet and cuff, can seen. ator to select select either either an adaptive adaptive pressure or a constant pressure at or to for the the tourniquet. tourniquet. for Following hardware hardware modifications, to existing modifications, changes changes to Following softexisting software were were made made to to permit it to to function of an adaptive permit it adaptive function as part of prototype in the the following As part of of the following manner. As prototype in preoperative the preoperative preparation of a patient, the pneumatic preparation of patient, the pressure· pneumatic cuff cuff for for the the pressuremeasuring device device and and the the tourniquet measuring tourniquet cuff cuff are applied the applied to the patient, in Fig. The pressure-measuring illustrated in Fig. 2. patient, as illustrated 2. The pressure-measuring module module and printer then activated, and the activated, and and printer are then the printer printer is is checked checked to that reasonable reasonable measurements of systolic assure that measurements of systolic pressure are being induction of Following induction being generated. generated. Following of anesthesia anesthesia and and exsanguination of of the limb for for surgery, the guination the limb the tourniquet activated in in tourniquet isis activated the "constant state. The the "constant pressure" pressure" state. The tourniquet tourniquet can then be then be changed changed to an adaptive adaptive state when when desired desired by by momentarily momentarily the depressing switch (see appropriate switch depressing the appropriate Fig. 2). LED indicators indicators (see Fig. 2). LED display display the the current state. In In the the adaptive adaptive state, state, values values of of PSM PSM are normally 1-min intervals normally obtained obtained at at I-min intervals by by analyzing analyzing the the character character string string generated generated by by the the pressure-measuring pressure-measuring module. module. In In the the presence of of excessive excessive artifact artifact or other other problems, problems, the the generation generation of of values values of of PSM PSM is is automatically automatically suspended suspended by by the the pressure-measuring pressure-measuring module module and and the the previously previously obtained obtained value value is is substituted substituted by by the the tourniquet. tourniquet. Successive Successive values values of = i which are PSM(ti), = 0, 1, ... ,N, thus obtained are checked PsM(ti), * **,N. for for compliance compliance with with the the following following three three criteria: criteria: 80 160; 80 <PSM(t,) <PsM(tD < < 160; At < 33 min tlt.;;;; min for for successive successive estimates estimates PSM(ti - At), ~t), PsM(ti and and - PsM(tD; PsM(td); IPSM(t)- PSM(ti- At)I < 32 mmHg. Failure Failure to to satisfy satisfy the the first first of of the the above-noted above-noted criteria criteria indicates indicates that that the the patient's patient's systolic systolic pressure falls falls outside outside generally generally acac· cepted cepted limits, limits, and and therapeutic therapeutic action action may be be required. required. Failure Failure to to satisfy satisfy the the second second criterion criterion may indicate indicate the the presence of of excessive excessive artifact artifact or other other problems problems requiring requiring operator interinter· vention. vention. Failure Failure to to satisfy satisfy the the third third criterion criterion indicates indicates aa flucfluc· (c) ~~~~~~~~(c) Adaptive Adaptive tourn iquet tourniquet Ps O,L---~~---72-----3~--~4----~5--~~ 3 4 5 Time {min} Time (min) Fig. cuff for for a Fig. 3. 3. Comparative Comparative tourniquet tourniquet pressures PT in upper·limb PT in upper-limb cuff (a) conpatient with rapidly patient with rapidly fluctuating fluctuating systolic systolic pressure Ps for (a) (t) for PS (t) ventional pneumatic pneumatic device device with 300 mrnHg, with PT venitional mmHg, (b) micromicroPT set at 300 PT set at approximately approximately 80 processor-based device with PT processor-based device with 80 mmHg above the preoperative systolic and (c) adaptive the patient's patient's preoperative systolic level level (see (see text), text), and adaptive described in the example example given the text. device with with PT device in the in the PT set as described text. given in Note that that the the adaptive adaptive tourniquet Note tourniquet in in this case would achieve the the maintaining a safe lowest while still lowest mean cuff cuff pressure while still maintaining safe margin beintraoperative systolic pressure. tween cuff cuff pressure and and intraoperative systolic pressure. 1 2 tuating systolic pressure tuating systolic pressure which which again may require require operator again may intervention. intervention. In In the the event that one one or or more more of of these these criteria event that are satisfied, the are not not satisfied, the prototype prototype is is programmed programmed to to revert revert from an adaptive state state to to aa constant-pressure state, at an adaptive constant-pressure state, the initially at the set while simultaneously set pressure, pressure, while simultaneously activating activating an an audiovisual alarm alarm to to indicate the change change of of states. The alarm alarm can can be be supsup· indicate the states. The pressed pressed by by momentarily momentarily depressing depressing an an "alarms "alarms reset" reset" switch on tourniquet (see 2) which on the the tourniquet (see Fig. Fig. 2) which will will leave leave the the device device in aa constant-pressure constant-pressure state; state; the the operator operator can can change change back back to to the adaptive state by adaptive state by activating activating the the appropriate appropriate switch switch after after any remedial remedial action action has has been been taken. taken. In In the the event event that that successive values values of of PSM PSM satisfy satisfy all all of of the the above-noted above·noted criteria, criteria, pressure in in the the tourniquet tourniquet cuff cuff is is adaptively adaptively changed changed by by the the prototype in in accordance accordance with with (7), (7), (8), (8), and and (9), (9), assuming assuming standard standard blood pressure pressure and and tourniquet tourniquet cuffs cuffs are are employed employed on on opposite opposite upper upper limbs. lower-limb surgery, limbs. For For cases cases of oflower-limb surgery, or or for for other other cases cases such as as those those involving involving use use of of nonstandard nonstandard cuffs cuffs as as described described below, the 1M and and fT IT specified specified approappro· the same same equations equations can can be be used used with with fM as functions functions of of their their variables. variables. priately as priately Fig. Fig. 33 illustrates illustrates comparative comparative cuff cuff pressures pressures arising arising from from the use of aa conventional conventional pneumatic pneumatic tourniquet tourniquet set set at at aa traditional use of level, level, the the microprocessor-based microprocessor-based device device set set at at aa constant constant prespres· sure of the the patient's patient's preoperative sure based based on on aa determination determination of systolic systolic pressure, pressure, and and the the microprocessor-based microprocessor-based device device in in an an adaptive adaptive mode. mode. According According to to common common practice, practice, the the convenconven· tional tional tourniquet tourniquet would would be be set set at at approximately approximately 300 300 mmHg mmHg for for upper-limb upper·limb surgery; surgery; this this value value is is roughly roughly consistent consistent with with the the level level suggested suggested by by the the nominal nominal values values given given in in the the example example above above which which led led to to (10). (10). In In aa constant-pressure constant·pressure state state the microprocessor-based microprocessor-based tourniquet tourniquet could could safely safely be be set set at at approxapproximately imately 80 80 mmHg mmHg above above the the preoperative preoperative systolic systolic level, level, as as sugsuggested gested in in the the literature literature (e.g., (e.g., [21, [2], [9]) [9]) and and by by the the nominal 126 126 BIOMEDICAL ENGINEERING, ENGINEERING, VOL. VOL. BME-29, BME-29, NO. NO.2, FEijRUARY 1982 1982 IEEE TRANSACTIONS ON BIOMEDICAL 2, FEBRUARY values to (II), that intraoperative intraoperative systolic systolic values which which led led to (11), assuming assuming that 45 mmHg pressure would would not increase by by more than 45 not increase more than mmHg throughthroughpressure out the touran adaptive state the the tourIn contrast, in an the procedure. contrast, in adaptive state out procedure. In of approximately niquet threshold of approximately 50 50 constant threshold niquet maintains maintains aa constant The mmHg periodically measured pressure. The measured systolic systolic pressure. mmHg above above periodically result is is aa mean mean tourniquet tourniquet pressure pressure which which is is significantly significantly result lower than than in two cases. cases. It It should be noted noted from from in the other two should be lower the other Fig. 33 that that the the adaptive tourniquet is is capable maintaining an capable of of maintaining an Fig. adaptive tourniquet adequate margin margin of rapid and and signifiof safety despite relatively relatively rapid signifiadequate safety despite cant increases increases in systolic pressure. pressure. Thus, the results results of of initial initial in systolic cant Thus, the of lab tests tests indicate that the the adaptive adaptive tourniquet tourniquet is is capable capable of lab indicate that maintaining intraoperatively intraoperatively aa cuff cuff pressure pressure close the minito the miniclose to maintaining for to assure assure aa bloodless bloodless field field for mum safe pressure necessary mum safe pressure necessary to surgery. surgery. DUAL-FUNCTION CUFF CUFF DUAL-FUNCTION A modules for for periodically determinA number number of noninvasive modules periodically determinof noninvasive various algorithms algorithms could be ing systolic pressure by by means of'various could be ing systolic pressure means of employed in the prototype. This is because in a configuration employed in the prototype. This is because in a configuration Figs. 11 and systolic pressure such as as the the one one illustrated and 2, 2, systolic pressure is is such illustrated in in Figs. of a separate cuff applied to an measured through the use of a separate cuff applied to an measured through the use upper limb limb not not involved involved in in the the surgical procedure, i.e., surgical procedure, i.e., tourtour-upper are applied separate niquet cuff and pressure cuffs cuffs are applied to to separate niquet cuff and blood blood pressure one dual-function dual-function linibs. would be be preferable preferable to to employ employ one limbs. It It 'would cuff both purposes: purposes: for for example, upper (proximal) for both an upper cuff for example, an (proximal) segment of cuff could could be be employed of such such aa cuff employed for for measuring measuring syssyssegment tolic pressure pressure periodically periodically and'a and a lower could lower (distal) (distal) segment segment could tolic be be maintained maintained at pressure. The The use use of one dualdualat aa suprasystolic of one suprasystolic pressure. function cuff in conjunction with with the the adaptjve in conjunction function cuff adaptive tourniquet tourniquet might reasons, e.g., be desirable for aa variety of reasons, variety of e.g., occlusive occlusive cuffs cuffs might be desirable for on upper limbs affect intravenous on both both upper limbs might intravenous administration administration might affect of fluids medications [25]. A separate blood pressure pressure of and medications fluids and [25]. A separate blood to aa lower cuff coqld be applied involved with the cuff lower limb limb not not involved with the could be applied to of two two cuffs cuffs would be surgical procedure, procedure, but but application application of would still still be surgical and physically obstructive. more cumbersome, and more labor-intensive, labor-intensive, cumbersome, physically obstructive. The development of of aa combined combined dual-purpose dual-purpose cuff, however, The development cuff, however, is clearly dependent upon the use in the aqaptive tourniquet the in the use adaptive tourniquet is clearly dependent upon of of aa noninvasive pressure-measuring module module employing an employing an noninvasive pressure-measuring algorithm capable capable of of accurately accurately measuring measuring pressure pressure with with greatly greatly algorithm reduced blood blood flow flow at measurement site. at the the measurement site. reduced of systolic pressure Published data data indicate that measurement measurement of systolic pressure Published indicate that under such using aa manual conditions using manual sphygmomanometric under such conditions sphygmomanometric technique based based on on K-sound K~sound analysis analysis is possible [21], is possible [21], [26]. [26]. technique However, it it was was anticipated the outset outset that that automatic automatic meameaat the However, anticipated at surement under under such such conditions conditions might less accurate accurate and and be less surement might be less reliable with an algorithm based based on K-sound analysis analysis than than an algorithm on K-sound less reliable with on oscillometry, with an an algOrithm based on oscillometry, primarily primarily because because it it with algorithm based be more was thought thought that algorithms would would be more depenwas that K-sound depenK-sound algorithms on flow-related dent than oscillometric dent than oscillometric algorithms flow-related phenomena phenomena algorithms on [21], To initially initially test test this this hypothesis, an experiment hypothesis, an experiment [21], [25]. [25]. To was conducted with the the configuration co~figuration of devices illustrated illustrated in in was conducted with of devices to aa Vitastat Vitastat Model was first connected to Model Fig. 4. Each subject was first connected Fig. 4. Each subject monitor with 900-S blood blood pressure pressure monitor with the the cuff cuff located located proximally proximally 900-S on an upper limb; the Vitastat Model 900-S normally measures on an upper the Model 900-S normally measures limb; Vitastat an of blood based on an algorithm based on analysis of K-sounds, analysis K-sounds, blood pressure pressure by by algorithm but second algorithm but automatically to aa second based on switches to on algorithm based automatically switches oscillometry if microphone in deliberately deacif aa microphone in the the cuff cuff isis deliberately deacoscillometry tivated. As by Fig. Fig. 4, 4, aa standard Kidde pneumatic pneumatic tivated. As suggested standard Kidde suggested by '7) /' TOURNIQUET CUFF 4. Configuration employed for for obtaining comparative estimates estimates obtaining comparative Fig. 4. Configuration employed by oscillometry -sound analysis analysis with blood with blood of systolic pressure by oscillometry and and K K-sound flow greatly reduced by by means of aa distal to cuff inflated inflated to flow means of distal tourniquet tourniquet cuff greatly reduced aa suprasystolic suprasystolic pressure (see (see text). text). tourniquet cuff with aneroid aneroid gauge gauge and bulb was was then then conand bulb contourniquet cuff with to nected to the the same limb of distal to of the the subject, subject, immediately immediately distal nected to same limb 845 blood the blood-pressure blood-pressure cuff. A Dinamap Dinamap Model Model 845 blood pressure pressure the cuff. A monitor the other other upper upper limb in order order to the limb in monitor was was then then connected connected to to obtain reference pressure by by oscillometry. of systolic values of systolic pressure oscillometry. to obtain reference values In the experiment, both pressure-measuring pressure-measuring devices devices were were actiactiIn the experiment, both to obtain at 'I-min intervals to obtain comparable vated Simultaneously at intervals comparable vated simultaneously 1-min estimates of of systolic pressure. By By successively activating and and successively activating estimates systolic pressure. deactivating the Vitastat microphone during this period, this Vitastat the microphone during period, deactivating alternating measurements measurements based based on oscillometry and and K-sound K-sound on oscillometry alternating for comparison analysis were obtained obtained from one limb limb for comparison with with from one analysis were tourniThe other limb. oscillometric measurements from the other limb. The tournifrom the oscillometric measurements quet cuff cuff was then quickly pressure to aa suprasystolic inflated to was then suprasystolic pressure quet quickly inflated of (approximately 250 mmHg) and measurements of systolic measurements and systolic (approximately 250 mmHg) for another pressure continued in the same manner for another 44 min. the manner min. in same pressure continued The cuffs were then switched to corresponding positions to on The cuffs were then switched corresponding positions on The opposite limbs and the same experiment was repeated. The was same experiment repeated. opposite limbs and the results the first first six are given Table I. in Table I. tested are six subjects given in results from from the subjects tested The results show that in all six subjects either an oscillometric either an oscillometric The results show that in all six subjects to meameaalgorithm or algorithm could could be be employed K-sound algorithm or aa K-sound employed to algorithm sure systolic pressure at the measurement site, despite greatly sure systolic pressure at the measurement site, despite greatly reduced blood flow at the due to an inflated inflated tourniquet to an the site site due tourniquet reduced blood flow at and experimental cuff. Table also indicates indicates for for each each subject cuff.' Table II also subject and experimental simultaneous condition the difference between between simultaneous the maximum condition maximum difference at the limb and measurement pressure on on the the test test limb and at the of systolic measurement of systolic pressure reference The results in Table Table II emphasize emphasize reference site. site. The results summarized summarized in of systolic systolic pressure the variation in in indirect indirect measurements measurements of the variation pressure which can be anticipated anticipated when measuring over periods over short short periods which can be when measuring at at the when measuring measuring simultaneously on opposite opposite the same same site, simultaneously on site, when limbs, or or when when measuring measuring with with devices devices employing employing different different limbs, algorithms or even implementations of of the the same even different different implementations same algorithms or algorithm. In these respects, of the initial experiIn these the results results of the initial experialgorithm. respects, the ment tended tended to with previous previous findings findings of others arising ment to agree of others arising agree with from extensive extensive studies, e.g., [21], blood prespresA blood from [24], [25]. [25]. A studies, e.g., [21], [24], sure employing an algorithm (see (see Fig. an oscillometric monitor employing oscillometric algorithm Fig. 2) 2) sure monitor the prototype was for incorporation an adaptive adaptive was chosen incorporation into into the prototype of of an chosen for because tourniquet intended for dual-function cuff cuff because tourniquet intended for use use with with aa dual-function module for for this has . die use of of an oscillometric module this application application has the use an oscillometric the it eliminates for aa microphone need for microphone in eliminates the the advantage advantage that that it the need in the precision the reduces the precision required required in in the dual-function dual-function cuff, cuff, itit reduces it may positioning the the cuff cuff on on the the limb, limb, and and it may permit permit measuremeasurepositioning in situations ments of pressure to pe made made in of systolic to be situations where ments where systolic pressure measurement by K-sound K-sound analysis be difficult. measurement by would be difficult. Although Although analysis would aa discrete discrete commercially commercially available available oscillometric oscillometric device was device was employed initially, an module or module based based an oscillometric or aa module oscillometric module employed initially, on the on aa K-sound K-sound algorithm algorithm could clearly be be incorporated into the could clearly incorporated into prototype of of adaptive in the the future future if if warranted. warranted. prototype adaptive tourniquet tourniquet in Authorized licensed use limited to: The University of British Columbia Library. Downloaded on April 21, 2009 at 14:19 from IEEE Xplore. Restrictions apply. 127 127 EWEN AND AND MC MC GRAW: GRAW: TOURNIQUET FOR IMPROVED IMPROVED SAFETY SAFETY IN IN SURGERY SURGERY MC MC EWEN TOURNIQUET FOR TABLE II TABLE MEAN SYSTOLIC SYSTOLIC PRESSURES LIMB MEAN PRESSURES OBTAINED OBTAINED SIMULTANEOUSLY FROM AA TEST TEST LIMB SIMULTANEOUSLY FROM AND A REFERENCE REFERENCE LIMB, AND LIMB, BEFORE BEFORE AND AND AFTER INFLATION OF OF AA TOURNIQUET AFTER INFLATION TOURNIQUET ON THB THE TEST CuFF CUFF ON TEST LIMB. LIMB. RESULTS ARE GIVEN GIVEN FOR FOR SIX SIX SUBJBCTS AND FOR FOR RESULTS ARB SUBJECTS AND CoNTRALATERAL CONTRALATERAL UPPBR UPPER LIMBS LIMBS FOR LIMBS SUCCBSSIVELY SUCCESSIVELY SERVING SERVING AS TEST LIMBS AS TBST FOR EACH SUBJECT. EACH SUBJECT. SBB SEE TEXT EXPLANATION TEXT FOR FOR FuIlTHBR FURTHER EXPLANATION A PRE-INFLAT ION PRE-INFLATION POST-INFLATION POST-INFLATION Mean Pressures Pressures (mmHg) (mmHg) Mean 5liljectl renee Li rrb : Reference Lirrb: iMaximLlll Test limb: Test Lirrb: Limb: )Reference Test Limb: Refe Reference Linb: Test Litb: Maximum Subject/ Test Subject/ Test Limb: Test Linb: Sliljectl Tes ci 11 ome try Testt Lirrb K-Sounds Oscillometry K-Sounds Oscillometry DifferenceTest Lirrb Linb K-50unds Limb K-Sounds Oscillometry Osci Test Oscillowetry 11 ome try Oi fferenceOscillometry Os Oscillometry Simul taneousI 5i multaneous Msmts Msmts I I"ean Mean Pressure (mrrI-Ig). (mmHg) I I I I1 Maximum Maximum Oiffe renceDifferenceSimu1 Simul taneous taneous Msmts Msmts J/Left J/Left 134 134 140 )40 139 139 -8 -8 J/Left J/Left 117 117 130 130 132 132 -20 -20 J/Right J/Right 129 129 1 34 134 1 45 145 -17 -17 J/Right /JRight III 111 138 138 136 136 -23 -23 R/Left R/Left 136 136 133 133 139 139 -99 R/Left R/Left 144 144 129 129 139 139 -11 R/Right R/Right 146 146 123 123 140 140 -23 -23 R/Right R/Right 146 146 129 129 140 140 -15 W/Left W/Left 136 136 138 138 1~/Left 130 130 137 137 -11 -11 141 141 -14 -14 W/Left WI Ri ght W/ Right 131 131 136 136 141 141 1 144 144 -13 -13 W/ Right W/Right 136 1-36 137 137 138 138 +9 +9 K/Left KlLeft 105 105 103 103 119 119 -23 -23 K/Left K/Left 112 112 102 102 114 114 -13 -13 K/Right K/Right 102 102 109 109 116 116 -16 -16 KlRight K/Right 110 110 102 102 115 115 -16 -16 E/Left E/Left 110 110 127 127 138 138 -29 -29 E/Left E/Left 108 108 124 124 134 134 -29 -29 E/Right E/Right 133 133 124 124 1~ 130 -12 -12 E/RiQht E/Ricght 141 141 130 130 126 126 +22 ! I M/Left M/Left 127 127 131 131 136 136 -16 -16 M/Left M/Left 130 130 120 120 1 30 130 -18 -18 M/Right M/Right 118 118 131 131 126 126 -11 -11 H/RiQht M/Right 132 132 118 118 125 125 +8 For an an initial initial assessment assessment of of the the feasibility feasibility of of aa dual-function For dual-function cuff, aa' commercially available two-chamber commercially available two-chamber tourniquet cuff, tourniquet cuff cuff (Zimmer Inflatomatic Inflatomatic Dual Dual Cuff) Cuff) normally normally used used for for intrave(Zimmer intravenous regional regional anesthesia anesthesia was was connected connected to to the the adaptive adaptive tourntournnous niquet. This This cuff cuff functioned functioned satisfactorily satisfactorily in in lab the niquet. lab tests, tests, with with the proximal section employed employed for determinations of of proximal section for periodic periodic determinations systolic and the section maintained systolic pressure pressure and the distal distal section at suprasysmaintained at suprasystolic As expected, expected, values of systolic systolic pressure tolic pressure. pressure. As values of deterpressure determined in this manner high in comparison to mined in this manner were were high in comparison to simultaneous simultaneous determinations on the the contralateral determinations on contralateral limb, limb, likely to the the due to likely due fact fact that that the the cuff cuff was was much much narrower narrower than than conventional conventional blood blood pressure pressure cuffs cuffs and and was was of of nonstandard nonstandard design design [20], [20], [23]. On [231. On the of aa dual-function the basis basis of of these these initial initial results, results, samples samples of dual-function cuff cuff specifically specifically intended intended for for evaluation evaluation with with the the prototype prototype have have been been fabricated fabricated by by aa manufacturer manufacturer of of conventional conventional tournitourniquet quet cuffs. cuffs. The The proximal proximal (upper) (upper) section section of ofth~ dual-function the dual-function cuff cuff has has dual dual ports ports for for connection connection to to the the pressure-measuring pressure-measuring module module of of the the adaptive adaptive tourniquet, tourniquet, but but has has aa narrower narrower width width and and other other physical physical differences differences which which necessitate necessitate that that 1M in fM in (4) be specified. specified. The The distal distal (lower) (lower) section section of of the the cuff cuff also also has has (4) be dual dual ports ports for for connection connection to to the the pressure-controlling pressure-controlling portion portion of I), so of the the tourniquet tourniquet (see (see Fig. Fig. 1), so that that it it can can be be adaptively adaptively inflated inflated to to the the minimum minimum pressure pressure necessary necessary to to maintain maintain aa bloodless bloodless field. field. As As with with the the pressure-measuring pressure-measuring section, section, the the width width and and other other physical physical characteristics characteristics of of the the pressure-control pressure-control section section of of the the cuff cuff have have been been changed, changed, necessitating necessitating aa deterdetermination mination of offT h for for use use in in (8). (8). The The primary primary reason reason for for reducing reducing the the width width of of both both sections sections in in relation relation to to conventional conventional cuffs cuffs was to minimize was to minimize surgical surgical obstruction. obstruction. An An evaluation evaluation of of these these new new dual-function dual-function cuffs cuffs must must be be made made to to determine determine their their reliability reliability and and define define fM 1M and and fT h prior prior to to employing employing them them in in clinical clinical trials. trials. If If the the results results of of the the trials trials of of these these cuffs cuffs are are promising, other other sizes sizes and and shapes of dual-function cuffs will dual-function cuffs promising, will shapes of be be fabricated for evaluation on upper and lower lower limbs limbs having evaluation on fabricated for upper and having aa variety of shapes and sizes. variety of sizes. shapes and DISCUSSION DISCUSSION Further work is being carried out in connection with Further work is being carried out with the the development and and clinical clinical evaluation evaluation of of the prototype of of the development adaptive tourniquet and various cuffs such the dual-function various cuffs such as the adaptive tourniquet and dual-function cuff cuff described described above. above. Following of a technical Following completion of evaluation of of the adaptive prototype and and cuffs cuffs by by biomedical the adaptive evaluation staff to assure that they perform to expectations, engineering staff much as possible possible with with pertinent standards, standards, that they they comply comply as much that and that an adequate level of reliability reliability has been achieved, a clinical evaluation evaluation will will be be completed. completed. In the clinical evaluation clinical as as in in past past clinical clinical trials trials of of the the microprocessor-based microprocessor-based tourniquet, tourniquet, the the prototype prototype will only only be be used used with with aa biomedical biomedical engineer in constant attendance attendance and and with with aa conventional tourniquet constant available immediately immediately as as backup backup in in the the event of unforeseen available problems. problems. Other Other work work will will be be carried carried out out to to determine determine whether whether or fM in or not not fT IT and and 1M in (3) (3) and and (5) (5) can can be be set set automatically automatically and and whether whether or or not not changes changes should should be be made made to to the the adaptive adaptive softsoftware ware to to accommodate accommodate lower-limb lower-limb surgery surgery with with and and without without dual-function dual-function cuffs. cuffs. Also, Also, if if the the results results of pf the the initial initial clinical clinical evaluation evaluation are are promising, promising, the the hardware hardware and and software software will will be be revised revised and and an an oscillometric oscillometric pressure-measuring pressure-measuring module module may be be physically physically incorporated incorporated into into the the prototype prototype so so that that it it can be of surgical surgical procedures be clinically clinically evaluated evaluated in in aa wide wide variety variety of over an an extended extended period. period. over The of the the current generation of The widely widely recognized recognized inability inability of pneumatic tourniquets tourniquets to to control control pressure pressure with adequate pneumatic accuracy, reliability, reliability, and and stability stability has has clearly clearly been associated accuracy, with of tourniquet-related tourniquet-related injuries, injuries, incidents, incidents, with continuing continuing reports reports of Authorized licensed use limited to: The University of British Columbia Library. Downloaded on April 21, 2009 at 14:19 from IEEE Xplore. Restrictions apply. 128 128 IEEE NO.2, IEEE TRANSACTIONS TRANSACTIONS ON ON BIOMEDICAL ENGINEERING, VOL. VOL. BME-29, NO. 2, FEBRUARY 1982 and hazards. and operating the labor-intensiveness labor-intensiveness and and hazards. Moreover, Moreover, the pneumatic with the the use use of of current current types of pneumatic costs associated associated with types of tourniquets have have significant cost implications for hospitals. tourniquets significant cost implications for hospitals. To extent the of aa microprocessor-based microprocessor-based tournitourniTo aa large the advent advent of large extent quet capable of safely and and accurately of safely desired quet capable accurately maintaining maintaining aa desired pressure and performing other and capable of simultaneously other pressure capable of simultaneously performing functions of alarm has reduced reduced functions such such as as detection detection of alarm conditions conditions has these hazards hazards and and operating-cost operating-cost implications. implications. Furthermore, these Furthermore, the availability of aa microprocessor-based has the availability of microprocessor-based tourniquet has facilitated the development of an an adaptive adaptive tourniquet in which in which facilitated the development of the pressure pressure in changed throughout throughout aa the in the the tourniquet tourniquet cuff cuff isis changed as aa function of the patient's changing surgical procedure procedure as function of the patient's surgical changing intraoperative systolic pressure, thus thus approximately apprOximately the the intraoperative systolic pressure, minimum safe pressure necessary necessary to to maintain bloodless field minimum safe pressure maintain aa bloodless field for surgery. While use of for surgery. While the the use of an an adaptive rather adaptive tourniquet, tourniquet, rather than just aa microprocessor-based set at than just at aa constant microprocessor-based tourniquet tourniquet set constant pressure may be necessary in most promises to not be most cases, to pressure may not necessary in cases, itit promises have value in procedures and in certain and for for have significant significant value certain surgical surgical procedures patients who be at of tourniquet-induced who may at greater risk of patients may be greater risk tourniquet-induced complications, e.g., patients patients with protective musculature. musculature. with little little protective complications, e.g., The tourniqliet may permit aa safer pressure to also permit to The adaptive safer pressure adaptive tourniquet may also be employed hypertrophied limbs (having aa suboptimal with hypertrophied limbs (having be employed with suboptimal ratio width to if appropriate appropriate values values of ratio of of cuff cuff width to circumference) of circumference) if fr and 1M be determined determined automatically entered manually fM can be automatically or entered manually fT and for such such patients. patients. Also, Also, the lower average pressures possible possible for the lower average pressures through the use of an adaptive permit the of an the the use through adaptive tourniquet tourniquet may may permit evolution of longer evolution of of surgical duration without without surgical techniques techniques of longer duration increase in risk of in the the risk of tourniquet-induced aa concomitant concomitant increase comtourniquet-induced complications. Finally, Finally, despite the increased increased complexity of the the plications. despite the complexity of adaptive that the between estimated that the difference difference between adaptive tourniquet, tourniquet, itit isis estimated of the the adaptive adaptive device the projected the projected capital capital cost cost of device and and aa comcommonly used used type of pneumatic pneumatic tourniquet may be be offset after offset after monly type of tourniquet may two years years of reduced operating costs two of normal normal usage due to to reduced usage due operating costs arising from elimination need for gas and and elimination of of the the need for compressed arising from compressed gas reduced labor-intensiveness. reduced labor-intensiveness. Klenerman, "Tourniquet ~'Tourniquet time-How long?" Hand, Hand, vol. vol. 12, pp. [9) L. L. Klenerman, time-How long?" 12, pp. [9] 231-234,1980. 231-234,1980. [10) S. Weingarden, D. D. L. Louis, and and G. W. Waylonis, Waylonis, "Electromyo"ElectromyoL. Louis, S. I.I. Weingarden, G. W. [10] matic 1248matic tourniquet," tourniquet," J. J. Amer. A mer. Med. Med. Ass., Ass., voL vol. 241, 241, pp. pp. 1248- 1250, 1979. 1250,1979. [11) H. Rorabeck Rorabeck and and J. J. C. C. Kennedy, Kennedy, "Tourniquet-induced "Tourniquet-induced nerve nerve [11] C. C. H. ischemia complicating knee ligament ligament surgery," surgery," Amer. J. Sports ischemia complicating knee Med., vol. vol. 8, 8, pp. 98-102, 1980. 98-102,1980. Med., H. Rorabeck, Rorabeck, "Tourniquet-induced "Tourniquet-induced nerve nerve ischemia: ischemia: An An experiexperi[12) C. H. [12] C. vol. 20, 20, pp. pp. 280-286, 280-286, 1980. mental investigation," mental investigation," J. J. Trauma, 1980. Trauma, vol. B. Jarem, Jarem, "Pneumatic "Pneumatic tourniquets," tourniquets," AnesAnes[13) H. Flewellen Flewellen and and B. E. H. [13] E. vol. 5, 5, pp. 31-34,1978. thesiol. Rev., vol. thesiol. 31-34,1978. · [14) J. Arenson Arenson and and L. Wei!, "The uses and and abuses abuses of of tourniquets tourniquets D. J. L. S. S. Weil, "The uses [14] D. J. Amer. Amer. Pod. Pod. Ass., Ass., vol. vol. 66, 66, pp. pp. in field foot in bloodless foot surgery," bloodless field surgery," J. 854-861, 854-861, 1976. 1976. Flatt, "Tourniquet time in in hand hand surgery," surgery," Arch. Arch. Surg., Surg., vol. vol. [15) A. E. E. Flatt, [15] A. "Tourniquet time 104,pp. 190-192, 1972. 104, pp.190-192,1972. [16) M. Bruner, "Time, "Time, pressure and and temperature factors factors in in the the safe J. M. [16] J. of the the tourniquet," tourniquet," Hand, vol. vol. 2, 2, pp. 39-42, 39-42, 1970. use of 1970. (17) J. C. Griffiths and O. 0. B. Heywood, "Bio-mechanical aspects of Griffiths and [17] J. Heywood, "Bio-mechanical the tourniquet," vol. 5, pp. 113-117,1973. the tourniquet," Hand, vol.5, 113-117, 1973. (18) "Ischaemic effects external and and internal internal pressure on A. 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Instrum., vol. of measuring arterial blood Part I," 15, 15, pp. 11-21, 11-21, 1981. 1981. , "Comparison "Comparison of of direct direct and and indirect indirect methods methods of of measuring measuring [22) [22] -, arterial.blood pressure, Part Part II," II," vol. vol. 15, 97-101, 1981. arterial-blood 1981. 15, pp. 97-101, (23) (Proposed) Non-Automated Sphygmomanometers, Standard for for Non-Automated [23] (Proposed) Standard Sphygmomanometers, Arlington, VA, Aug. 1980. Ass. Advancement Med. Instrum., Arlington, (24) (Proposed) Electronic or Automated Automated Sphygmomano[24] Standard for for Electronic (Proposed) Standard SphygmomanoAss. Advancement Advancement Med. Med. Instrum., Instrum., Arlington, Aug. meters, Ass. meters, Arlington, VA, VA, Aug. 1980. 1980. D. P. P. Paulus, Paulus, "Noninvasive "Noninvasive blood b100d pressure measurements," measurements," Med. Med. (25) D. [251 vol. 15, pp. 91-94, 1981. 1981. Instrum., vol. 15,pp.91-94, (26) F. F. H. H. Vanbergen al., "Comparison "Comparison of of direct direct and and indirect indirect methmeth[26] et al., Vanbergen et ods of of measuring blood pressure," pressure," Circulation, vol. vol. 10, ods measuring arterial arterial blood 10, pp.481-490~ 1954. pp. 481-490, 1954. ACKNOWLEDGMENT ACKNOWLEDGMENT The provided by by Dr. M. A. A. The clinical advice and and assistance assistance provided clinical advice Dr. M. Wachsmuth of the Division Division of Orthopaedic Surgery, Surgery, University University Wachsmuth of the of Orthopaedic of of British British Columbia the Columbia isis gratefully gratefully acknowledged, acknowledged, as as isis the engineering assistance of of R. MacNeil, M. M. Koombes, E. Ho, Ho, engineering assistance R. MacNeil, Koombes, E. J. Ing, lng, and and E. of the Department of EngiJ. E. Froese Froese of the Department of Biomedical Biomedical Engineering, neering, Vancouver Vancouver General General Hospital and the Department of Hospital and the Department of Electrical Engineering, University of of British British Columbia. Electrical Engineering, University Columbia. REFERENCES REFERENCES [11 H. "Surgical technique," Campbell's Operative [1) H. Smith Smith "Surgical technique," in in Campbell's Operative OrthoOrthoLouis, MO: MO: Mosby, p. 58. paedics, 5th 5th ed. ed. St. paedics, St. Louis, Mosby, 1971, 1971, p.58. [2] R. R. Sanders, Sanders, "The Instrument or or weapon?" Hand, vol. vol. [2) "The tourniquet: tourniquet: Instrument weapon?" Hand, 5, pp. 119-123,1973. S pp.119-123,1973. [3] J.J. C. Adams, Standard Operation& New [3) C. Adams, Standard Orthopaedic Orthopaedic Operations. New York: York: Churchill and and Livingston, Livingston, 1976, 1976, pp. 4-5. Churchill pp. 4-5. A. McEwen, [4] J.J. A. McEwen, "Complications "Complications of of and and improvements improvements in in pneupneu[4) matic tourniquets used in surgery," vol. 15, 15, pp. surgery," Med. Med. Instrum., Instrum., vol. pp. matic tourniquets used in 253-257,1981. 253-257, 1981. [5] D. Fry, Fry, "Inaccurate "Inaccurate tourniquet tourniquet gauges," [5) D. gauges," Brit. Brit. Med. Med. J., J., vol. vol. 1,1, p.p. 511,1972. 511,1972. [6] S. J. Prevoznik, from use use of of pneumatic tourniquets," [6) S. J. Prevoznik, "Injury pneumatic tourniquets," "Injury from Anesthesiol., vol. vol. 32, Anesthesiol., 32, p. 177, 177, 1970. 1970. [7] D. L. L. Johnson, P. D. D. Neufeld, R. G. G. Hussey, Hussey, "Hazards "Hazards in in Johnson, P. Neufeld, and and R. [7) D. single-stage regulation regulation of cuffs," J.J. Clin. 5, of pressure pressure cuffs," Clin. Eng., Eng., vol. vol. 5, single-stage pp. 59-62, pp. 59-62, 1980. 1980. [8] of the the Kidde Kidde automatic automatic tourniquet," tourniquet," in in Medical [8) "Malfunction "Malfunction of Medical Devices Alert Alert No. No. 16, Health Protection Canada, Dec. Devices 16, Health Protection Branch, Dec. 13, 13, Branch, Canada, 1978. 1978. James A. McEwen McEwen (S'74-M'75) (S'74-M'75) received received the the James A. of British British Ph.D. ddegree from the University of the University egree from Jh.A. 1975. Columbia, Vancouver, Vancouver, B.C., B.C., Canada, Canada, in in 1975. Columbia, of the the Biomedical Biomedical Engineering Engineering He is He is Director Director of the Vancouver Vancouver General General Hospital Hospital Department at the 1 Department ' the and the Health Health Sciences Centre Hospital Hospital at the and the Sciences Centre 9 University of British British Columbia, the largest largest University of Columbia, the its kind kind in in Canada. Canada. He He is is also also department of of its if ILI| department the Department Adjunct Associate Associate Professor Professor in in the Department Adjunct of of Electrical Electrical Engineering Engineering at at the the University University of of British Columbia. Columbia. He is is a Registered Registered ProfesProfesBritish sional Engineer and and a Certified Certified Clinical Clinical Engineer. His main interests are sional Engineer in clinical clinical engineering engineering and of need-oriented medical medical in and in the development of of diagnosis and treatment, technology in in order to improve technology improve the qualtiy of of health health care. care. and and control control the the costs costs of Dr. McEwen is Medical and and Dr. McEwen is a member member ·ooff AAMI AAMI and and the Canadian Canadian Medical Biological Engineering Biological Engineering Society. Society. iEi M.D. degree University of of from the the University Robert W. McGraw received the M.D. degree from B.C., Canada, Canada, in in 1960. 1960. British Columbia, Vancouver, B.C., He is is currently in the the Division Division of of Orthopaedic Orthopaedic Surgery, Surgery, He currently aa Professor Professor in British Columbia. Columbia. of British Faculty of Medicine, Medicine, at the University of the Royal Royal College College of Surgeons of Surgeons Fellow of of the Dr. McGraw McGraw became aa Fellow of (Canada) (Canada) in Orthopaedic Surgery Surgery in in 1966. 1966. He became a Diplomate Diplomate of the American Board of of Orthopaedic Surgery in and a Fellow Fellow of of in 1972, the American Board Orthopaedic Surgery 1972, and Academy of of Orthopaedic Orthopaedic Surgery in 1975. American Academy 1975. the American Surgery in