METHOD AND APPARATUS FOR MONITORING TENDON MOTION
FIELD OF THE INVENTION
This invention relates to a method and apparatus which can be used to monitor
energy signatures which are related to specific exchanges or motions during relative
movement of the carpal tunnel (wrist) contents, including the tendons, ligaments, synovium, median nerve, muscles, cartilage and bones. More specifically, the invention
relates to a method and apparatus for analyzing and identifying energy signals or signatures associated with movement of tendons within the carpal tunnel, whereby dynamic, real-time, monitoring of these signals or signatures can be used to diagnose, reduce, alter, or prevent the incidence of so called "idiopathic" carpal tunnel syndrome.
BACKGROUND OF THE INVENTION
Carpal-tunnel syndrome (CTS) is at present the most widespread occupational
health hazard in the industrial world. Many billions of dollars are consumed each year in lost working time and in the diagnosis and treatment of this syndrome. Although some of the physiological factors associated with idiopathic CTS are well documented, including a
non-inflammatory increase in the volume of synovium resulting in an increase of pressure in the carpal tunnel contents, the etiology of the change in the quantity or quality of the
synovium has remained obscure.
Tendons in general have high longitudinal strength and rigidity, but are soft compliant tissues in the transverse direction, much like a bundle of fine wires, which can be easily molded to different cross-sectional shapes, even under tension longitudinally. The
synovium wraps around, nourishes, and lubricates the nine tendons of the extrinsic muscle
tendon units which pass through the carpal tunnel. Each finger of the hand utilizes two of
these nine tendons, with the thumb utilizing the last, to flex and/or stabilize the joints of the
digits. The median nerve also passes through the carpal tunnel to innervate certain muscles and provide sensation to related areas of the hand. Any increase in volume of the carpal tunnel contents, either synovium or tendons, may result in compression of this nerve with
secondary signs and symptoms of CTS.
In anatomic areas other than the caφal tunnel, the biomechanical effect of each tendon is defined by discrete fiberosseous tunnels which effectively form pulleys. These
pulleys dictate the precise offset and location of the tendons as they cross a joint to generate
the rotational forces or moments needed to effect controlled angulation and stability of each
joint. A pulley with a precise moment arm is required in the carpal tunnel for each tendon as it crosses the carpus. Due to the compliant nature of the synovium, these pulleys can
only be formed and maintained in the carpal tunnel, for all motions of the carpus, by a
synergistic tensioning of all nine tendons of the carpal tunnel to form "dynamic soft tissue pulleys" for each tendon.
Without this dynamic action, a singular contraction of a muscle tendon unit results in tension in the related tendon, causing the tendon to rapidly accelerate and translate
transversely across the carpal tunnel until it loses energy via collisions with surrounding soft tissue (synovium, other tendons, lumbrical muscles, or median nerve) or the more rigid
wall of the carpal tunnel (bone or ligament); this may also be referred to as "snapping" action. Under such conditions, the singularly loaded tendon loses the tissue-generated moment arm which is required for precise control over the associated finger movement.
The energy-related parameters associated with transverse translation and related collisions between a carpal tunnel tendon and other surrounding structures are defined as
aspects of that tendon's "energy signature". The energy signature of a carpal tunnel tendon,
therefore, refers to transverse velocity, transverse acceleration, collision signal frequency, collision signal magnitude, transverse displacement magnitude, transverse displacement
direction, etc. Indeed, the energy signature of a transversely translating carpal tunnel tendon may be characterized by one or a combination of any of the following parameters:
1 ) sound amplitude, frequency, and phase of associated tissue vibrations;
2) tendon velocity, magnitude, and direction;
3) tendon displacement and direction;
4) tendon acceleration and direction;
5) behavior of the tendon velocity, displacement or acceleration over time
(profiles);
6) kinetic energy or momentum of the translating tendon;
7) intensity of the kinetic energy associated with transverse tendon translation;
8) force transferred by a tendon to other associated tissues during transverse tendon translation;
9) frequency of events of a certain tendon velocity, displacement, acceleration, kinetic energy, intensity, or force;
10) viscoelastic behavior of the tendons, median nerve and synovium as defined by the interaction between the tendons or the interaction between the
tendons and median nerve or synovium during transverse tendon translation;
and
11) changes in any of the above parameters over time or as a function of hand use which are associated with transverse tendon translation.
Each of the above parameters would desirably be quantified for comparison with
other benchmarking data.
As is described above, the brain normally orchestrates the simultaneous activation of all the proper muscle tendon units to produce dynamic soft tissue pulleys which stabilize the tendon or tendons actually doing the work. The onset of CTS is associated with
scenarios wherein the orchestration between brain and caφal tunnel muscle tendon units
does not provide adequate dynamic soft tissue pulley stabilization. The occurrence of
potentially injurious transverse tendon acceleration, translation, and subsequent collision with associated tissue structures is believed to be particularly likely when a person uses his hand to accomplish a familiar task repeatedly, such as depressing various keyboard keys over and over during typing, or when a person operates his hand in relatively cold
temperatures or under conditions of decreased sensory perception as in a gloved-hand scenario. Some hand activities, such as meat packing, combine several of these scenarios and are known for their relatively high correlation with the onset of CTS symptoms. Other
common tasks such as typing, knitting, and peeling vegetables also have been linked to the
occurrence of CTS.
In addition, the tasks most closely associated with CTS symptoms are complex hand operation tasks (also termed "functional hand use" because such movements are related to a task-oriented functional operation of the hand rather than particular hand
muscle activation) requiring the use of several hand-related muscles in concert rather than merely the passive or active flexion of a single finger, for example. This may be the result
of different "programming" of the hand muscles by the brain when a person is asked to perform a complex task, such as placing groceries into a bag repeatedly using his hands, as compared with a scenario wherein a person simply is asked to move a particular joint of his
finger repeatedly. Indeed, a general lack of potentially pathophysiologic collision signals
resulting from transversely translating caφal tunnel tendons during particularized hand
muscle activations has been experimentally confirmed. One of the objectives behind the subject invention is to provide a diagnostic tool for determining which hand use tasks are
more likely to be associated with the onset of CTS symptoms for a given individual.
Normal synovium is a filmy, compliant tissue which is incapable of significantly
resisting any translational repositioning of the tendons transversely across the caφal tunnel.
In the presence of unstable tendons accelerating transversely against adjacent tendons and other structures as they cross the c-upal tunnel, the synovium is subjected to repetitive shear and other stresses which result from the interaction between translating tendons and the
synovium. Such stresses result in thickening of the synovium and loss of elastic
compliance. More specifically, the continuing application of stress to the synovium over
time alters the extracellular matrix which comprises the synovium; this results in a thickening of the tissue and loss of overall elastic compliance. As the synovial thickening occurs over time, the pressure is increased in the caφal tunnel due to geometric constraints.
This increased pressure can result in the compromise of blood supply to the median nerve
and symptoms of CTS.
Concomitant with the change in the extracellular matrix of the synovium is a change in the viscoelastic properties of the synovium. As the synovium becomes thicker, it
becomes a better dampener of rapidly accelerating and transversely translating caφal tunnel
tendons, resulting in a different energy signature.
Changes in the material characteristics of synovium also have been suggested as a
cause of increased adhesions between the median nerve and the surrounding tissues
(transverse caφal ligament and flexor tendons). These adhesions restrict the normal motion (both longitudinal and transverse) of the median nerve and may cause increased
mechanical stress in the nerve. This restriction of mobility also may be a contributor to the
development of CTS. Decreased mobility of the median nerve results in alterations in the energy signature associated with tendons translating transversely through the caφal tunnel.
Currently, there is no method or apparatus to monitor the motions of the tendons in
the caφal tunnel and distinguish whether their energy signatures are normal (related to proper soft tissue pulley action and little or no damage to surrounding soft tissues) or pathophysiologic (related to accelerations in the transverse direction and collisions with
other tissues in such a way as to cause injury to either the tendons or the other surrounding
tissues). Energy signatures considered to be normal may include representations of
longitudinal tendon motion which occurs as the fingers are flexed and extended. Pathophysiologic energy signatures are related to changes in the tissues which predispose the individual to the onset of CTS (typically idiopathic). A method or apparatus for
monitoring, detecting, and evaluating the dynamics of tendons which move transversely through the caφal tunnel and collide with surrounding tissues could serve as an important
tool for diagnosing and facilitating a reduction in the occurrence of CTS.
The existence of both tendon and median nerve motion in the caφal tunnel has been previously observed using limited experimental protocols. K. Nakamichi and S. Tachibana
reported using ultrasound to visually image a shift in position of both the tendons and median nerve in the caφal tunnel while subjects performed the non-functional task of
active-resistive flexion of the fingers. The results of their study was published in
"Transverse sliding of the median nerve beneath the flexor retinaculum", The Journal of
Hand Surgery, April 1992, Vol. 17B, No. 2, pp. 213-216. Similar tendon and median nerve motion within the caφal tunnel was reported using a passive flexion-extension of the index finger protocol by K. Nakamichi and S. Tachibana in "Restricted motion of the median
nerve in caφal tunnel syndrome", The Journal of Hand Surgery, August 1995, Vol. 20B, No. 4, pp. 460-464. In both reports, the authors detected movement of the nerve in the
transverse direction and commented on the nerve's physical relationship with the caφal tunnel tendons. However, there was no method or apparatus by which the transverse
movements of the tendons or nerve were monitored and analyzed during hand use to
determine whether any parameters of the energy signatures associated with such movement were indicative of either potential damage to or existing damage of the surrounding soft
tissues. As is discussed above volatile tendon dynamics within the caφal tunnel, those
which are most likely correlated with CTS, generally are not produced during such simple hand operations. In other words, active or passive flexion of a single finger or two fingers, as was the protocol in the above-referenced experiments, is not likely to produce CTS
pathophysiologic caφal tunnel tendon dynamics. In addition, although these authors were able to conclude that the tendons and nerve may shift transversely within the caφal tunnel, they did not monitor transverse tendon velocity using Doppler ultrasound, micro impulse
radar, or other techniques capable of velocity measurement, they did not monitor collision signal magnitude or frequency using available transducer devices, and they were not able to
quantify the transverse tendon dynamics findings; quantified transverse tendon velocity
ranges and associated collision magnitudes and frequencies may be directly correlated with
injurious tissue dynamics.
More particularly, the aforementioned authors did not employ Doppler ultrasound techniques to monitor transverse tendon velocities. Doppler ultrasound techniques rely upon a shift in frequency, or Doppler shift, which is the difference between the incident
frequency of emitted ultrasound waves and the reflected frequency of carrier ultrasound waves. In the case of ultrasound being reflected from moving tendon tissues, successive
Doppler shifts are involved as the tendons move transversely across the caφal tunnel. First, ultrasound radiation is transmitted from a stationary transducer, say one mounted
upon the exterior of the wrist, to moving tendon tissues. Second, the moving tendon tissues reflect some of the incident ultrasound back to a transducer which functions as a
reflected signal receiver. The two frequencies may be subtracted, and, given the
propagation speed of surrounding soft tissues, the angle of incidence between the moving tendons and the ultrasound beam direction, and the carrier wave frequency, the velocity of the moving reflector tissues, in this case caφal tunnel tendons, may be calculated.
Some authors have reported the use of either ultrasound or microphones to either
qualitatively or quantitatively describe the motion of tendons in the caφal tunnel (such as reported by Cigali et. al., 1996; Sugamoto et. al., 1998; Buyruk et. al., 1998; Buyruk et. al., 1996; Markison, 1990). However, what has been described by these authors has been the
normal movement of tendons in the longitudinal direction and not in the transverse
direction. In addition, none of these authors describe a method or apparatus capable of
monitoring the motions of the tendons in the caφal tunnel and evaluating their energy signatures for pathophysiologic tendencies.
Radar techniques may also be used to calculate velocity for a given structure given
that structure's change in position over time. Modern radar devices, such as those using
"micro impulse radar" technology disclosed in references such as U.S. Patent No.
5,345,471, are capable of high sampling frequencies and thus enable accurate velocity calculation for moving objects, such as transversely translating tendons. Such devices, in
particular, are capable of sampling rates greater than 10MHz and have relatively favorable
system noise rejection. These devices have not heretofore been used to monitor tendon
dynamics within the caφal tunnel or predict or diagnose pathophysiologic tissue
movement.
It would be highly desirable to have an apparatus and method for monitoring energy signature parameters related to transverse tendon translation within the caφal tunnel during performance of various hand use tasks. It would also be highly desirable for the system to
be capable of evaluating and quantifying the monitored energy signature parameters to determine whether the hand use tasks and associated caφal tunnel tendon activity are likely to be CTS pathophysiologic or not. The inventive apparatus and method described herein accomplish such goals.
SUMMARY OF THE INVENTION
This invention provides an apparatus and method for monitoring and analyzing the energy signatures associated with the movement of tendons transversely across the caφal tunnel. The monitoring results may then be analyzed and used diagnostically or as part of a
preventative plan wherein feedback may be provided to or about the person being
monitored to permit, encourage, or force that person to alter their hand movement pattern
whereby potentially detrimental transverse tendon translation is reduced. Such reductions may result in a lower occurrence of CTS or the minimization of its deleterious effects.
In one variation, the invention is an apparatus for monitoring and evaluating the
activity of tendons within the caφal tunnel comprising an energy signature monitoring
device and a signal processing device. In this variation, the energy signature monitoring device is configured to monitor energy signature parameters related to transverse tendon
translation during performance of a hand use task, produce signals associated with the
tendon activity, and communicate with the signal processing device. The signal processing
device is configured to evaluate and quantify the signals and determine whether the associated tendon activity is likely to be CTS pathophysiologic or not.
In another variation, the invention is a method for monitoring the activity of tendons within the caφal tunnel comprising monitoring at least one energy signature parameter related to transverse tendon translation during performance of a hand use task, and
evaluating and quantifying the at least one energy signature parameter to determine whether
the associated tendon activity is likely to be CTS pathophysiologic or not.
In another form of the apparatus, transducer means are used, either implantable within the wrist area or positioned over the skin in the wrist or hand area (or other areas of
the body acoustically linked to the caφal area), for monitoring characteristics of the energy
signature which are associated with transverse tendon translation in the caφal tunnel.
The apparatus may further comprise means for providing information gathered by
the transducer means to a person or to a computer, such that the information may be compared with previously obtained and stored data. Additionally, the apparatus may
comprise means for providing feedback to or about the person on whom the transducer
means have been placed. The feedback information may be delivered to the subject in real time ("active feedback"). Such feedback may be used to prevent potentially injurious
movements and/or promote movements which limit deleterious (pathomechanic) transverse
tendon translation, thereby resulting in more clinically favorable energy signatures.
In a more specific, active feedback, form of the invention, transducers are
positioned over the hand or wrist areas of the user by either embedment in an enveloping or
band-like garment or directly adhered to the skin. Energy signature characteristic information is gathered and analyzed relative to stored benchmarking information which has been clinically related to injurious activity in the caφal tunnel. Depending upon this
comparative analysis, a feedback algorithm is used to select and transmit feedback to the patient and encourage the patient to adopt more clinically favorable movements via the feedback itself, or by restricting operation of the equipment being used.
The invention also includes a method comprising the steps of monitoring energy signature characteristic information from within the wrist, and conducting comparative
analysis with other stored information to determine if the monitored information is
indicative of potentially injurious transverse tendon translation.
Advantages of the invention will be apparent from the following detailed description and the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
The invention is described in more detail hereinafter with reference to the
accompanying drawings wherein like reference characters refer to the same parts throughout the several views and in which:
FIGURE 1 is a partially cut-away perspective view of a hand showing some of the various
tendons in the hand which control finger and thumb movement;
FIGURE 2 is a cross-sectional view through the caφal tunnel showing dorsal displacement
of the sublimis tendon during its muscle's contraction;
FIGURES 3 and 4 show a sublimis tendon in the hand before and during muscle
contraction, respectively;
FIGURE 5 is a diagram showing the elements of an apparatus or method according to the
invention;
FIGURE 6 is a partial cross section depicting the use of two transducers to monitor caφal
tunnel tendon dynamics; and
FIGURE 7 is a partial cross section depicting the use of Doppler ultrasound techniques to monitor transverse tendon velocity.
DESCRIPTION OF THE PREFERRED EMBODIMENT
The foundation of the present invention is the recognition that so called idiopathic
caφal tunnel syndrome, particularly as it occurs in keyboard operators, is a result of the way in which people use their fingers, hands, wrists, and forearms, referred to as hand use
patterns. Typically, many subjects form habits or patterns of using the fingers with the distal joint extended so that, for example, the keys on a keyboard are pressed with the palmar aspect of the pulp of the finger, rather than with its palmar-distal tip. This "habit", along with a minimal actuation force requirement of the "modern" computer keyboard,
allows the relatively singular contraction of one of the extrinsic muscle tendon units
(typically the flexor digitorum sublimis), while leaving other extrinsic muscle tendon units relatively or absolutely relaxed where they pass through the caφal tunnel.
Due to angulation of the tendon as it crosses the wrist, tension in a singular tendon urges the tendon transversely against other tissues and may result in rapid acceleration and movement of this singular tendon transversely across the diameter of the caφal tunnel and
between the neighboring tendons. As a singularly activated tendon accelerates and
transversely translates, it collides with other tissues in the region, more specifically the synovial membranes of these other tissues and the median nerve, producing stresses, such as shear stresses and principal stresses, in the membranes and nerve. Repeated episodes of
application of such stresses to the synovial membranes of the associated tissue structures result in increased degrees of edema formation and an associated cellular transudate with
proteinaceous materials in the interstitial spaces whereby normal synovial tissue is
progressively converted to relatively inelastic "fibrous tissue." It is the continuation of this injury mechanism that ultimately results in a rise in caφal tunnel pressures, with secondary
signs and symptoms of CTS.
A progressive hypertrophy of tissues is alluded to in a monograph by Dr. Paul W. Brand, "Repetitive Stress on Insensitive Feet, The Pathology and Management of Plantar
Ulceration in Neuropathic Feet", U.S. Public Health Service Hospital, Carville, Louisiana. He referred to two tests where moderate loads were repetitively placed on rat foot pads. In the first, these repetitive stresses built up an inflammatory state day-by-day until it finally
caused an ulceration. In the second test, the same load was applied with 20 percent fewer daily repetitions and rest at weekends, which allowed the feet to pass through the inflammatory phase and move on to a hypertrophy of the tissues without inflammation,
which protected the foot from further damage. This hypertrophy is a commonly observed
phenomenon in the soft tissues of the body where moderate stress, more particularly shear stress, causes a thickened or callused area without inflammation.
The same process could be visualized in the caφal tunnel as a progressive transformation of the thin, relatively elastic synovial membrane into a more edematous,
thickened, and less compliant structure due to mechanical stresses such as shear stresses.
Pathophysiologically, this would cause an increase in caφal tunnel pressures paralleled by
the clinical development of CTS and its known signs and symptoms.
At first, a cyclic increase and then decrease in caφal tunnel pressure would be seen as the edema fluid would accumulate and then dissipate as a function of the level of injury
to the synovium. With persistent mechanical stress induced by the transverse motion of
caφal tunnel tendons, the thickening would progressively increase, thereby producing a constant increase in caφal tunnel pressures and an established clinical case of CTS.
To avoid this injury process, it is desirable to modify the hand use patterns of persons who may be routinely, but unknowingly, moving their wrists and digits in inappropriate or unhealthy ways. Before such modifications can be made, however, the
condition of the tendons, median nerve and synovium in the caφal tunnel must be
monitored and evaluated.
Since the use of keyboards is a common hand use which has been associated with CTS, such use can be used as a basis for explaining how monitoring can be achieved.
When a keyboard is to be used, the selection of an appropriate key actuation force can be determined from the anatomical dimensions of the distal joints of the fingers, along
with the strength of the flexor digitorum sublimus (FDS) muscle tendon unit as it acts at the proximal inteφhalangeal (PIP) joint. In terms of caφal tunnel tendons, the individual is
mainly using the FDS muscle tendon unit with the intrinsic muscles (flexor digitorum profundus electrically and mechanically silent) to depress a key, keeping the distal inteφhalangeal (DIP) joints relatively extended. The forces are transmitted through the DIP joints to the pulp at the tip of the distal phalanx, via the DIP joint capsular ligaments
and volar plate. The distal and middle phalanx act as one "rigid" structure, with key
actuation force provided by a single extrinsic muscle tendon unit, i.e. the flexor digitorum
sublimis only.
A simple way to inhibit this undesirable hand use pattern is to require forces greater than the FDS and intrinsic muscles can provide alone, without exceeding the combined capability of the FDS and FDP muscles. The total mechanics in the digits are very
complex, but in this case as described above, a simple analysis based on the geometry and FDS tendon forces should be sufficient. L.D. Ketchum from measurements in vivo, estimated the maximum tendon force capability in 40 individuals, as reported in "A clinical study of forces generated by the intrinsic muscles of the index finger and the extrinsic
flexor and extensor muscles of the hand", The Journal of Hand Surgery, Nov. 1978, vol. 3,
No. 6, pp. 571-578. He also measured the joint moment arms in 10 fresh frozen cadavers. The remaining anatomical data for the calculation is described by G. T. Lin in "Functional
anatomy of the human digital flexor pulley system", The Journal of Hand Surgery, Nov. 1989 vol. 14A, No. 6, pp. 949-956. Lin measured bone lengths in a radiographic
study of 10 hands. These measurements of bone length can be used to approximate the
distance from the PIP joint center of rotation to the middle of the pad of the distal phalanx.
The analysis is that of a simple structure with forces creating moments about the PIP joint center of rotation. If a force peφendicular to the axis of the phalanx is assumed,
the equation for the key force capability can be derived and is described as follows and is
calculated in the following table:
Key force = FDS tendon force x PIP moment arm/(DP length + MP length)
Finger DP length MP length FD
FDS Key mm mm mo
Force Force ran
Kg Kg
Index 18.73 24.03 8.3
6.91 1.34
Long 18.61 28.00 8.7
7.63 1.42
Ring 18.48 26.04 8.5
6.21 1.19
Little 16.85 18.57 7.4
3.73 0.78
Based on this nominal data, the desired key force for actuation would be in the range of one kilogram. Even though this is an average case, in reality, individuals with lesser or greater strength would find it difficult or impossible to type using the FDS alone with this level of force required. In any case, this analysis shows that calculations can be
made which provide guidance as to a specific method of avoiding finger movements which
may result in the symptoms associated with CTS. Such guidance is appropriate only where accurate information about what is going on within the caφal tunnel can be collected. Thus, this invention relates to the collection and use of such information, and the active or passive feedback of that information.
EXPERIMENTAL
Previous biomechanical studies (such as that reported by Martin Skie, et. al., in "Caφal tunnel changes and median nerve compression during wrist flexion and extension
seen by magnetic resonance imaging", The Journal of Hand Surgery, 1990, Vol. 15 A. pgs 934-9) have defined a potential for tension forces, in the caφal tunnel tendons of an
angulated wrist, to compress the median nerve against the flexor retinaculum.
A cadaver study was done to examine biomechanical factors that produce instability
of the sublimis digital flexor tendons in the caφal tunnel (reported by Agee et. al., in "Moment arms of the digital flexor tendons at the wrist: role of differential loading in
stability of caφal tunnel tendons", The Journal of Hand Surgery, Nov. 1998, Vol. 23 A, No. 6, pp. 998-1003). This study tested the hypothesis that tendon instability created by
differential tendon loading can be the initiating cause of "idiopathic" CTS.
When a single sublimus tendon is loaded in excess of its neighboring tendons, that tendon moves around adjacent tendons thereby providing the energy for mechanical
stresses and other cyclic load phenomenon that could lead to synovial thickening, loss of
both median nerve blood supply and mobility, and secondary CTS.
Six fresh cadaver specimens were instrumented to simultaneously monitor digital flexor-tendon excursion and wrist-joint angular displacement during arcs of wrist flexion-
extension, and radial-ulnar deviation. With each arc of motion, the instantaneous moment
arms of each of the caφal tunnel tendons were calculated and recorded. Baseline data defined the moment arms of these tendons at the wrist using identical tension loads in each tendon (85 grams). The experiment was then repeated four times with each sublimis tendon loaded higher than the other eight tendons (540 gms). Compared to the balanced
loads, a reproducible shift in moment arms was demonstrated with each sublimus tendon at the higher loading condition. This shift demonstrated tendon translation transversely across
the tunnel of that higher-loaded sublimus tendon, with a displacement of the other tendons
around it.
By repeating the experiment with the fingers in extension, mid flexion, and full
flexion, the potential effect of related structures, such as the anatomically linked profundus tendons and the lumbrical muscles, was considered.
The normally thin and compliant synovium of the caφal tunnel is mechanically incapable of assuring a continuous stable relationship between differentially loaded tendons of the caφal tunnel. This data supports the hypothesis that stability of single or multiple
caφal tunnel tendons can only be achieved by a continuous synergistic contraction of a host
of muscle tendon units orchestrated by the brain. This synergism allows neighboring tendons to provide a stable path for those tendons that are actually performing the
instantaneous tasks needed to accomplish a given finger/hand function. Tendon instability accompanying certain common hand use patterns may create transverse tendon translation,
with the mechanical energy from this movement being transferred to surrounding tissue structures, namely the synovium, in the form of cyclic mechanical stresses. Such stresses
lead to the edema, fibrosis, synovial thickening, and loss of both median nerve blood supply and mobility seen in idiopathic CTS. In the use of certain keyed instruments, such as the computer or piano, or certain occupational tasks, such as meat packing, an individual
operator may adopt certain hand use patterns that fail to "recruit" the synergistic muscle contractions necessary to stabilize the motions of each tendon as it performs its function.
By way of further description of the drawings, Figure 1 illustrates the tendons in the
hand which pass through the caφal tunnel within a tendon sheath (10) (tenosynovium or
ulnar bursa). Tension on the sublimis tendon (12) causes dorsal movement of the tendon
and subjects the inteφosed synovium (i.e., the "tendon sheath") to mechanical stresses,
such as shear stresses, which can result in micro trauma.
Figure 2 is a cross-sectional view through the caφal tunnel showing the manner in which tension on the sublimis tendon (12) causes dorsal movement of the tendon and
subjects the tendon synovium (sheath) to mechanical stresses such as shear stresses This
phenomenon is also illustrated in Figures 3 and 4.
Figure 5 is a block diagram depicting the monitoring apparatus or method of the
invention. Data is first obtained via a monitoring device which may comprise a transducer (16) or probe. Many types of monitoring devices, such as transducers, are well known in
the art of gathering data from the body. Any of these which are sensitive enough to
monitor characteristics of energy signatures associated with transverse tendon translation in the caφal tunnel will be useful in the invention. Indeed, the types of data collected from
suitable monitoring devices, the relevant anatomy, and hand use patterns which may be associated with tendon instabilities, among other factors, indicate that tendon translation can be monitored using any device that will measure the energy signature characteristics
associated with the interaction of caφal tunnel tendons and surrounding tissues (i.e., the synovium, other tendons, median nerve, and walls of the caφal tunnel) during tendon translation. Many types of devices are suitable for monitoring relevant aspects of caφal
tunnel tendon energy signatures.
In a preferred form, the invention is a method of monitoring the occurrence of transverse tendon translations. Such monitoring, in its simplest form, can be accomplished
through listening to characteristics of the energy signature which are in the range audible to the human ear (i.e., audible sounds which are a subset of the tendon motion), even though
other characteristics are detectable. A simple transducer such as a stethoscope may be used
to enhance the capability of the listener to identify particular aspects of energy signatures associated with transversely translating tendons, particularly sounds resulting from the rapid acceleration of tendons and the collisions between transversely translating caφal tunnel tendons and the tissues comprising the caφal tunnel structure including the related
synovium, median nerve, and other caφal tunnel tendons. Many suitable stethoscope or
similar devices are known in the art, such as those described in U.S. Pat. Nos. 5,883,340, 5,861,584, 5,825,895, 5,774,563, 5,638,453, and 5,550,902. Sensitive microphones, such as those described in U.S. Pat. Nos. 5,590,211, 5,673,330, 5,490,220, 5,359,157, 5,255,328,
and 5,161,200 may also be employed for transducing such sounds either directly, or in
concert with a stethoscope such as that described in U.S. Pat. No. 5,852,263 which incoφorates a microphone. Other types of acoustic transducers, such as those described in
U.S. Pat. Nos. 5,629,578, 5,486,734, 5,343,443, 5,335,210, 4,870,972, and 4,698,541, may also be employed for sound transduction.
For example, in one variation of the invention, an acoustic transducer such as a
microphone may be coupled to the skin in an overlying area of the subject's wrist and used
to monitor audible sounds emanating from the wrist during hand use patterns which produce potentially injurious transverse tendon translation. A suitable monitoring device
preferably will have the capacity to gather signal data falling within a broad frequency range, with high sensitivity, accuracy, and at a rapid sampling rate. The monitoring device
may also comprise means for gathering, storing, and analyzing the sound data. From the sound data, information regarding the pathophysiologic nature of the energy signature can
be extracted, including its collision signal amplitude, frequency, or phase. Signals
emanating from the monitoring device may be communicated to a signal processing device
capable of analyzing the signals for pathophysiologic characteristics.
Velocity and acceleration are aspects of a transversely translating caφal tunnel
tendon's energy signature which are highly relevant to the detection and prevention of CTS. This is because relatively high velocities and accelerations of caφal tunnel tendons may be
correlated with heightened frequency and magnitude of collisions with other tissues,
including synovial tissues, and therefore may also be correlated with greater inflicted
stresses upon such tissues. As is described above, heightened frequency and magnitude of
such stresses, especially when such stress application occurs over a relatively long time period, may be related to the development or occurrence of CTS. Further variations of the
invention are therefore designed to monitor energy signature characteristics such as transverse velocity and transverse acceleration of transversely translating tendons using any
number of known monitoring devices. Such variations generally require emission of a signal, such as an ultrasound beam or radar signal, which may be detected by the monitoring device after it has reached targeted tissue and been reflected by the tissue.
Other variations may employ X-ray or other common imaging techniques to pass a signal through targeted tissues, which may be radioopaquely labelled, and form images which
may be studied in series to calculate displacement, velocity, and acceleration. The monitoring device may be used to feed the information back to the person being monitored, or to others who need to know, such as a physician, supervisor, or employer after the
signals emanating therefrom are processed by a signal processing device capable of
analyzing such signals for pathophysiologic characteristics.
In one variation of the invention, for example, an ultrasound transducer, such as a
Doppler ultrasound transducer, may be coupled to an overlying area of the subject's wrist and used to emit and receive ultrasound signals. The ultrasound transducer may consist of
either a dual element transmitter/receiver or an array of transmitter/receivers; in both cases the ultrasound transducer may comprise both the signal emitting device and the monitoring device. Because ultrasound signals must be acquired while individuals perform hand use
activities and ultrasound signals are sensitive to loss of contact between the transducer and
the skin, care must be taken to either insure sufficient skin contact or mitigate the effects of
these erroneous signals. Many suitable ultrasound transducers are known in the art, such as those described in U.S. Pat. Nos. 5,823,962, 5,744,898, 5,678,554, and 5,418,759.
To ensure sufficient contact between the transducer and skin, a flex-circuit may be
utilized in association with the monitoring and signal emitting devices to minimize the
overall rigidity of the transducer and enable the device interfaces of the transducer to contour more closely with the changing shape of the skin surface. Suitable flex-circuit designs are well known in the art of electronic componentry and are described in references
such as U.S. Pat. Nos. 5,768,776 and 5,482,473. Attachment of the transducer to the skin may be accomplished using either an adhesive backed tape or a strap that applies contact
pressure between the transducer and skin. A bandlike member or garment may be
configured to hold the transducer in place against the skin, somewhat akin to the manner in which a tightened watch band holds a watch bezel against a portion of the forearm skin. A coupling gel such as that commonly used with ultrasound transducers can be used to
improve the transducer-to-skin coupling, and may be retained by a flexible circumferential coupling gel retainer member, preferably comprised of a compliant material such as
polyurethane, which surrounds the transducer interface and retains the coupling gel when the transducer is urged against the skin. Because the transducer may be worn for extended
periods of time while individuals perform one or more hand use tasks, it may be necessary
to replenish the coupling gel routinely. To avoid removal and reattachment of the
transducer if the coupling gel level becomes inadequate, a coupling gel replenishment port through a portion of the device may be used for supplying gel to the transducer-to-skin interface.
Multiple transducers may offer advantages for mitigating the effects from
transducer-to-skin coupling noise. Two transducers positioned closely together, but pointed in distinct non-overlapping directions, may be used to determine whether an energy signature characteristic is associated with an actual tendon translation or with coupling effects. If the signature characteristic in question is observed by both transducers, the
signal likely stems from coupling. If the signature characteristic is observed only in the
transducer directed toward the contents of the caφal tunnel, the signature most likely is associated with an actual tendon translation.
A dual transducer arrangement may also be useful in separating longitudinal motion of the tendons from transverse motion. In the orientation shown in Figure 6, two
transducers (100, 102) are positioned longitudinally outside of the caφal tunnel structural
tissue (104). In the case of longitudinal motion (107) of a caφal tunnel tendon (106), the first transducer (100) would see a Doppler frequency shift of the same magnitude as, but of opposite sign than, the shift seen by the second transducer (102). Transverse motion (108) of the tendon (106) would result in both transducers (100, 102) observing a Doppler
frequency shift identical in magnitude and sign.
Transducer performance is dependent on the acoustic impedance between the transducer and the skin. Acoustic impedance mismatch may result in undesirable reflection
of the ultrasound waves at the skin level. To reduce the acoustic impedance mismatch
between the transducer and the skin, impedance matching materials are preferably incoφorated either in the design of the transducer or in an interface layer between the transducer and the skin. Other suitable methods and devices for reducing impedance mismatch are known in the art of medical imaging, and are described in references such as
U.S. Pat. Nos. 5,511,424, 5,434,827, 5,423,319, and 5,386,395.
In the standard configuration, the transducer is connected to its associated analog circuitry by standard RF cable. However, because the performance of certain hand use
tasks may not be conducive to such a tethered connection between the transducer and its associated analog circuitry, a telemetry interface may be used to facilitate or enable data
collection. Suitable telemetry interfaces are known in the art of medical and other
electronic devices, and are described in references such as U.S. Pat. Nos. 5,899,931, 5,871,451, 5,782,890, 5,752,977, 5,704,351, and 5,694,940. In either case, amplification of the ultrasound signals may be performed within the transducer to improve the signal-to- noise ratio, as is described in various transducer references such as U.S. Pat. No. 5,191,327.
Knowing the Doppler shift frequencies enables computation of the velocities or
vector components of the velocities of the translating tendons. A Doppler ultrasound transverse velocity monitoring variation may comprise means for gathering, storing, and analyzing the velocity data. Such data may be used alone to predict and diagnose pathophysiologic hand and wrist biomechanics, or it may be combined with other useful
data extracted from the energy signatures of the caφal tunnel tendons, such as collision
signal information. Figure 7 is a diagram showing the transmission, reflection, and
detection of ultrasound beams from a transversely translating caφal tunnel tendon. Referring to Figure 7, a caφal tunnel tendon (106) is depicted translating transversely along a path (108) toward the structural wall of the caφal tunnel (104) while an ultrasound
transducer (100) sends and receives an ultrasound beam (112) which approaches the path (108) of the translating caφal tunnel tendon (106) at an angle (110) and is reflected back to
the transducer (100).
In another variation of the invention, a micro impulse radar device, comprising both
a radar signal emitter and a radar signal monitoring device, may be used to emit and receive
radar signals and calculate changes in position and thus velocity of transversely translating caφal tunnel tendons based upon the differences between emitted and received signals. A
high sampling frequency, given the velocity and transverse translation path of transversely translating caφal tunnel tendons, as well as Nyquist sampling accuracy requirements known to those skilled in the art of data acquisition facilitate accurate transverse velocity
data acquisition. Such transverse data may be used to predict and diagnose pathophysiologic hand and wrist biomechanics in a manner similar to that discussed above for Doppler ultrasound-based transverse velocity data. Micro impulse radar devices are further described in references such as U.S. Pat. Nos. 5,345,471 and 5,361,070.
Other electromagnetic signal forms, such as light, microwave, infrared, and X-ray
may also be used to monitor caφal tunnel tendon dynamics. In an additional form of the invention, the motion of tendons is monitored by means of a rapid motion magnetic resonance imaging signal emitting and monitoring device, commonly referred to as MRI or rapid MRI. This imaging modality gives a cross-sectional and/or three dimensional view of
the internal soft tissues in the body. With proper selection of the plane of the cross section, single or multiple tendons can be viewed as they pass through the caφal tunnel. With
pattern recognition software and sampling at adequate frequencies given the velocity and transverse translation path of transversely translating caφal tunnel tendons, as well as
Nyquist sampling accuracy requirements known to those skilled in the art of data acquisition , the translation of a tendon or tendons across the tunnel may be visualized and
recorded. The resultant data may be used in concert with a feedback and control system to
facilitate limitation or modification of the hand use patterns of the individual being
monitored. Other electromagnetic imaging devices and techniques, such as Computed
Tomography (CT), may be similarly utilized to monitor caφal tunnel tendon dynamics.
Combinations of any of the above referenced signal detection devices may be used to enhance the information contained in the energy signature of tendons translating
transversely across the caφal tunnel. Hand use requires coordination between the brain and muscles of the forearm and hand. Electric potentials are generated in both the brain and
muscles of the forearm and hand during hand use. The electric potentials in the brain and muscles may be monitored using tissue monitoring electrodes configured for
electroencephalography (EEG) and electromyography (EMG), respectively. Such techniques may be performed in combination with any of the above referenced signal
detection devices to correlate the pathophysiological tendon translations with certain
electric potential patterns. Suitable tissue monitoring electrodes for EMG analysis are described in references such as U.S. Pat. Nos. 5,785,040 and 5,593,429, as well as in "Repeatability of Phasic Muscle Activity: Performance of Surface and Intramuscular Wire Electrodes in Gait Analysis," J. Orthop. Res. 3:350-359, 1985. Suitable tissue monitoring
electrodes for EEG analysis are described in references such as U.S. Pat. Nos. 5,357,957,
5,038,782, and 4,967,038.
Data is optimally acquired while individuals perform their routine hand use tasks.
Monitoring of these individuals may be required for extended periods of time to acquire sufficient data for analysis. Because the active measurement devices discussed above involve electromagnetic radiation and certain levels of electromagnetic radiation have been
determined to exhibit certain exposure risks, the measurement system may be configured to
automatically monitor both the electromagnetic radiation dosage and the activity level of
the individual to limit its application as required.
In the preferred embodiment, energy signature data, such as sound or transverse velocity data, may be transmitted to a computer data acquisition board using a data transmission output line which is interfaced between the signature monitoring device or
transducer and the signal processing device. As is discussed above, the data communication link between the monitoring device and the signal processing device may comprise a telemetric, or wireless, communication link. Similarly, the communication link
between any of the physically separate components of a variation of the inventive apparatus may comprise a wireless communication link to facilitate physiologic biomechanics of the
tested person as well as ease of use. Components which communicate with other portions
of the apparatus using wireless communications links may require power supplies; such components are preferably configured to have small portable power supplies, such as batteries, which also do not require extraneous wiring. Because high sampling rates may be
required to collect the rapidly occurring tendon translation events, large datasets may exist. To reduce the amount of data, collection may occur after a triggering event. A frequency
or amplitude trigger allows signals above a cutoff frequency or amplitude to trigger data collection and reduction, thereby eliminating unnecessary data collection, reduction and
storage.
Many standard data storage devices may be employed, such as tape recorders, video
camcorders, oscilloscopes, or computer memory devices. Similarly, many electronic signal processing devices are known in the art of data acquisition and signal processing. In the
preferred embodiment, data is transmitted to a data acquisition board and is either stored and analyzed by computer software or processed by integrated digital signal processing
(DSP) before storage and further analysis by computer software. The computer software
may be used to analyze the incoming data (digital or analog) in real time, or later after it is retrieved from the computer storage device. The analysis conducted, preferably by computer, may include filtration, amplification, spectrum analysis, mixing, Fourier
transformation, wavelet transformation, and so forth, to view and extract relevant data
points from the raw energy signature information. Since the processed data is quantified data, analysis may also include comparative analysis wherein a comparator can be used to
examine the differences between the data points gathered and analyzed from the given subject and those from another subject, data file, or benchmarking dataset. Further analysis
may be performed using computer software to post-process the extracted data to determine more specific information regarding transverse tendon translation.
Integrated data collection, analysis and comparison devices are known for
monitoring other sounds generated in the body, most commonly the heart, and these devices may be incoφorated into the method or apparatus of the invention. An example of such a device is described in U.S. Pat. No. 5,010,889.
The analyzed or compared data may be used to generate a feedback signal (22) to provide feedback to the subject, or to someone working with the subject. The feedback
signal (22) portion of the apparatus or method of the invention may include active means
for controlling or altering the hand use patterns of the subject (such as disabling the keyboard of a computer if improper hand use patterns are detected). This method may thus
be used to allow a user to modify their hand use patterns to eliminate transverse tendon translation within the caφal tunnel, or, at the least, it can be used to identify those
individuals who will be at risk of developing CTS if they continue their hand use patterns without modification.
Each of the U.S. Patent documents, U.S. patent application documents, foreign
Patent documents, and scientific reference documents (including texts and scientific journal articles) referred to in the text of this document is incoφorated by reference into this document in its entirety.
Many alterations and modifications may be made by those of ordinary skill in the art without departing from the spirit and scope of this invention. The illustrated
embodiments have been shown only for puφoses of clarity. These examples should not be taken as limiting the invention defined by the following claims, said claims including all equivalents now or later devised.