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WO2002038047A1 - Dispositif et procede d'evaluation des lesions faites a des ligaments - Google Patents

Dispositif et procede d'evaluation des lesions faites a des ligaments Download PDF

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Publication number
WO2002038047A1
WO2002038047A1 PCT/US2000/041762 US0041762W WO0238047A1 WO 2002038047 A1 WO2002038047 A1 WO 2002038047A1 US 0041762 W US0041762 W US 0041762W WO 0238047 A1 WO0238047 A1 WO 0238047A1
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WO
WIPO (PCT)
Prior art keywords
joint
bone
ligament
signal
pressure member
Prior art date
Application number
PCT/US2000/041762
Other languages
English (en)
Inventor
Arie M. Rijke
Original Assignee
Rijke Arie M
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Rijke Arie M filed Critical Rijke Arie M
Priority to PCT/US2000/041762 priority Critical patent/WO2002038047A1/fr
Priority to AU2001250758A priority patent/AU2001250758A1/en
Publication of WO2002038047A1 publication Critical patent/WO2002038047A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/45—For evaluating or diagnosing the musculoskeletal system or teeth
    • A61B5/4533—Ligaments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Measuring devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/45—For evaluating or diagnosing the musculoskeletal system or teeth
    • A61B5/4528—Joints
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6828—Leg
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6829—Foot or ankle

Definitions

  • a medical device and method which provide quantitative information on the type and extent of injury to the ligaments of the ankle, elbow, knee and shoulder without the need for x-rays or other imaging modalities.
  • the invention combines stress equipment for ligaments with electronic sensors, a computer interface and analytical software containing predictive functions to provide the care provider with an accurate diagnosis of ligament injury.
  • the initial workup of ligament injury involves, after osteochondral fractures or other complications have been excluded, an accurate assessment of the extent of ligament damage. Determining the extent of the damage to ligaments allows the physician to make the appropriate choice of treatment, including whether or not surgery is required. Equally important is monitoring the functional improvement in order to assess the success of rehabilitation programs.
  • the typical methods for evaluating damage to ligaments are physical ex-tmination, stress examinations including stress radiography, and occasionally magnetic resonance imaging (MRI), computerized axial tomography (CAT) scan and arthroscopy.
  • MRI magnetic resonance imaging
  • CAT computerized axial tomography
  • MRI can directly image the affected ligament, it is unable to assess function properties.
  • each of these diagnostic tools has its own intrinsic value, and contributes to the total assessment of the actual injury, it is evident that, together, they also markedly add to the total cost.
  • a leg positioning device for taking x-rays is described in U.S. Patent 4,232,681 and is one example of an early device for diagnosing ligament injury. The information contained in this patent is incorporated by reference in its entirety.
  • This device sold as the GA- II/E Stress Device by the Telos Corporation (Marburg, Germany) enables the examiner to position the limb and apply a measured force to the joint but requires the physician to take x-rays in order to assess the likelihood of injury to the ligament.
  • the GA-II/E is capable of positioning multiple joints including the ankle, the knee and the shoulder for x-ray analysis of their ligaments.
  • Another technology currently in use to measure joint laxity includes the knee and shoulder testers sold by the Medmetric Corporation (San Diego, CA). These devices include the KT 1000 and KT 2000 knee testers and are described in US Patent Numbers 4,969,471 and 4,583,555. A shoulder tester is also described in US Patent Number 5,911,695 and a patella displacement tester is described in US Patents 5,156,163 and 6,013,039. These patents are incorporated by reference as though reproduced in their entirety. The devices described in these patents use force displacement measurements combined with linear displacement of the appropriate bones to provide diagnostic information on joint laxity.
  • Each of these devices is limited to the assessment of the laxity of a single ligament, and therefore the purchase of multiple systemswould be required to test the various joints resulting in an increase in the cost to the physician and the patient. Further, the only information that is provided to the physician is the actual measurement of the force and the displacement, and the physician would be required to further manipulate this information- in order to arrive at a diagnosis in terms of percentage tear.
  • the novel process of the invention employs a modification of commercially available stress equipment used to assess trauma-induced laxity in a variety of joints including the ankle, knee, elbow and shoulder.
  • Electronic sensors attached to the stress equipment measure the location of specific anatomical reference points. These measurements are used in mathematical models to calculate the percentage of remaining or regained function in the traumatized ligaments without the use of imaging modalities or invasive procedures.
  • Computer software presents the results and diagnosis in a clinical format.
  • the examination is performed in a matter of minutes and at a fraction of the usual cost by a trained technician and does not require a hospital setting.
  • the preferred embodiment of the assembled device is available in a lightweight briefcase-sized portable unit and can be operated wherever a PC or laptop is available.
  • the invention improves standard graded stress radiographic exams to eliminate the need for x-rays or other imaging modalities, and it makes ligament stress exams accessible to non-radiological personnel, such as athletic trainers, without loss in diagnostic accuracy.
  • Figure 1 is a flow diagram of the generic process involved in diagnosing ligament injury.
  • Figure 2 represents a simplified view of the orientation of the invention when used on the ankle and the angular changes during testing that occur due to ankle injury.
  • Figure 3 represents the configuration of the stress device for measurement of ankle ligament injury.
  • Figure 4 shows the configuration of the stress device when it is tested for anterior calcaneal ligament injury.
  • Figure 5 shows the configuration of the stress device when it is tested for deltoid ligament injury.
  • Figure 1 shows a flow diagram of the generic diagnostic process entailed by the invention.
  • the extremity to be tested is appropriately positioned in a stress device 10 and a force is applied to the joint of interest (ankle, knee, elbow or shoulder).
  • the displacement caused by the applied force is read by incremental encoders 12 and a digital or analog signal is generated.
  • An interface board 14 reads the signal and causes conversion to a digital signal if necessary.
  • the interface board processes the force displacement signal and sends the information to a computer processor 16 which analyzes the information using the trigonometric functions described below and presents the information in a clinical format.
  • the invention comprises two main components:
  • Component I Electronic sensors are attached at appropriate locations to commercially available ligament stress equipment. The sensors measure the change in the location of anatomical reference points in an extremity as a function of a range of measured forces which are exerted on a specific anatomical reference point in the joint being tested. It should be noted that the present invention is not limited to any particular type of sensor.
  • Rotary encoders are attached at each of the two points where the ankle piece can be inserted into the stress device, and these encoders measure the rotation of the ankle piece.
  • a shaft on the bottom of the ankle holding piece slides into a hole on the Telos device; the entire ankle holding piece can swivel on this shaft.
  • the rotary encoders are located at the base of this shaft, so that they can measure the rotation of the shaft.
  • a linear encoder is attached to the device in line with the pressure plate to measure the distance that the pressure plate travels while the force is being applied.
  • To test the ankle requires rotational measurements from the rotary encoder, distance measurements from the linear encoder, and measurements of the force applied by the pressure plate.
  • To test knee, elbow, and shoulder ligaments only the distance measurements from the linear encoder and the measurements of the force applied by the pressure plate are required.
  • the use of these types of sensors enables the interface board to digitize and communicate with the diagnostic software.
  • Component II - Mathematical formulas manipulate the data gathered by the sensors in Component I to compute the change in the talar tilt angle of the ankle joint or the relative displacement of the bones in the knee, shoulder, or elbow joint.
  • the talar tilt angle is calculated which makes it possible to determine the remaining lateral or medial ligament function using the Graded Stress Technique (GST) system.
  • GST was first applied to ligaments as published by Rijke and colleagues in the journal Clinical Orthopaedics, Vol. 210, September, 1986, which is incorporated herein by reference in its entirety. Such analysis has correlated well with arthrography and operative techniques as described in Rijke et al., The American Journal of Sports Medicine, Vol. 16, No. 3, 1988, pps.256- 259 and in Rijke & Vierhout, Acta Radiologica, vol. 31, 1990, pps. 151-155 which are incorporated herein by reference in their entireties.
  • the formulas used to calculate the talar tilt reflect the specifics of the human leg and ankle anatomy as well as the dynamics of the stress equipment. Specifically, the distance from the counter plate B to the ankle joint (distance BC in Fig. 2B and distance BE in Fig. 2C, respectively) is measured for each patient. The distance between the midpoints of the two extension arms on the stress device is also measured. This is distance AB in figures 2B and 2C. In addition, the distance between the midpoint of the threaded spindle holding the pressure plate and the midpoint of the extension arm holding the counter plate near the knee is measured. This is distance C in figure 2C. The formulas also allow for the unsuspected presence or unknown extent of • subtalar instability or hypermobility in the patient.
  • Figure 2A is a schematic representing the relationship between the ankle holding piece, the ankle joint, the counter plate, and the direction of the applied force when testing the ankle for lateral ligament insufficiency in a stress device.
  • AB represents the distance between the position of the ankle piece and the counter plate near the knee and C is the position of the ankle joint.
  • the pressure plate is positioned 2 cm proximal to the ankle joint, a distance c, from the counter plate.
  • Subtalar instability and hypermobility are uncommon insufficiencies of the ligaments of the foot involving, respectively, tears and overstietching of the talocalcaneal ligaments such as the cervical and interosseous ligaments as well as the capsule of the subtalar joint. Diagnostically, subtalar insufficiency is difficult to distinguish from the much more common lateral ankle sprain with symptoms and signs overlapping.
  • the software directly distinguishes between talar tilt ⁇ and subtalar tilt ⁇ and thereby make possible a prompt diagnostic distinction between the two entities - without perfo ⁇ ning any additional examinations. This is because the subtalar tilt ⁇ equals the difference between the talar tilt ⁇ , computed according to Equation 1 and the talar tilt ⁇ computed according to Equation 2. This relationship is expressed in Equation
  • the talar tilt ⁇ according to Equation 1 assumes the talocalcaneal joint to be rigid whereas the talar tilt according to Equation 2 assumes a measure of mobility in this joint.
  • Normal subtalar joints show a finite value for ⁇ , equaling that of the opposite foot. Hypermobility will show as slack in the talocalcaneal ligaments but will show normal visco-elastic behavior of these ligaments in the higher ranges of forces applied.
  • Instability is associated with partial or complete tears of the ligaments. This will show as abnormal force - subtalar tilt relationships from which the extent of tear including complete tears can be diagnosed accurately.
  • the instant invention not only facilitates the determination of both types of insufficiency in one, non-invasive examination, but also distinguishes between subtalar hypermobility and subtalar instability with quantitative assessment of ligament slack in the former and percentage of tear in the latter case.
  • Figure 3 is a graphic representation of a leg positioned in a Telos stress device to determine injury to the ligaments of the ankle.
  • a foot 18 is placed in the ankle holding piece 20 and attached to an extension arm 22.
  • the ankle holding piece 20 is free to rotate around a pin that affixes the ankle holding piece 20 to die extension arm 22.
  • a rotary encoder 24 is attached between the ankle holding piece 20 and the extension arm 22 to measure the rotation of the ankle holding piece 20.
  • a counter support 26 is attached behind the leg and the pressure device 28 is adjusted to impact the leg by pressing the release button 30 and sliding the pressure device 28.
  • a diagnosis begins by adjusting the turning grip 32 such that the pressure device 28 is moved along a threaded spindle 34 and force is applied to the limb.
  • Figure 4 shows the orientation of the ankle holding piece 20, the counter support 26 and the pressure device 28 when the right ankle is tested for anterior calcaneal ligament injury.
  • Figure 5 shows the orientation of the ankle holding piece 20, the counter • support 26 and the pressure device 28 when the left ankle is tested for deltoid ligament injury.
  • Assessing posterior cruciate hgament injuries requires a measurement of the translation of the joint rather than the widening of the joint space, and thus a different position of the pressure plate and the counter plates in the conventional stress device.
  • the amount of translation in the joint has also been found to be sufficiently proportional to the distance traveled by the pressure plate to make this measurement useful for the GST system, so this distance can once again be used to compute the extent of injury using the GST system.
  • a special wrist fixation device has been designed and patented (U.S. Patents 5,724,991 and 5,462,068) to do this job.
  • the unilateral widening of the joint space has now been found to be sufficiently linearly proportional to the distance traveled by the pressure plate to make this measurement useful for the GST system, so this distance can once again be used to compute the extent of injury using the GST system without the need for x-rays.
  • Telos equipment originally designed for stress examination of ankle and knee ligaments, includes an optional shoulder positioning device that features a support bar on which the pressure plate can be mounted.
  • a force from the pressure plate can be applied in a correct anatomical position and direction to measure (and record on x-rays) humero-glenoid subluxation, in a manner similar to that in which the laxity of knee ligaments are routinely measured.
  • the force - displacement relationship in suspected shoulder ligament insufficiency can be recorded by our new technology using the linear encoder mounted on the pressure plate and processing the data by our software without the use of x-rays.
  • the Shoulder tester as described in U.S. Patent 5,911,695 assigned to Medmetric Corporation of San Diego CA, is a modified KT model that operates on the same principle of applying force and measuring the resultant movement in the joint.
  • Our software is capable of measuring the force - displacement relationship as recorded by the Shoulder tester and computing the percentage ligament damage (or recovery) in the same fashion as is done for knee ligaments using the KT2000 model in conjunction with our software.
  • the software performs all calculations necessary to arrive at the diagnosis, expressing the post-injury condition of the involved ligaments in terms of percentage remaining function or, if on rehabilitation, recovery of function.
  • the program allows easy access to all data gathered and processed for comparison, reproducibility or cross checking for operator errors in the event of unexpected results. Users will also be able to access a national database compiled by the collective user program for comparison with gender/age related groups.

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Abstract

L'invention porte sur un procédé et un dispositif de quantification et suivi du pourcentage de fonctionnalités d'un ligament par des mesures externes de points de référence anatomiques à l'aide de capteurs électroniques ajoutés à des dispositifs existants de contrainte de ligaments, puis application de modèles mathématiques aux mesures fournies par les capteurs. L'extrémité à vérifier est placée dans un dispositif de contrainte (10) et on applique une force sur l'articulation considérée. Le déplacement produit par la force est lu par des codeurs incrémentaux (12) qui émettent des signaux. Un circuit interface (14) traite lesdits signaux et transmet les informations au processeur (16) d'un ordinateur qui les analyse à l'aide de fonctions trigonométriques pour déterminer le pourcentage des fonctionnalités du ligament et présenter les informations dans un format clinique.
PCT/US2000/041762 2000-11-02 2000-11-02 Dispositif et procede d'evaluation des lesions faites a des ligaments WO2002038047A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
PCT/US2000/041762 WO2002038047A1 (fr) 2000-11-02 2000-11-02 Dispositif et procede d'evaluation des lesions faites a des ligaments
AU2001250758A AU2001250758A1 (en) 2000-11-02 2000-11-02 Device and method for evaluating ligament injuries

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2000/041762 WO2002038047A1 (fr) 2000-11-02 2000-11-02 Dispositif et procede d'evaluation des lesions faites a des ligaments

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008040790A1 (fr) * 2006-10-05 2008-04-10 Genourob Dispositif de detection et de suivi d'une lesion du ligament croise anterieur du genou
FR2906699A1 (fr) * 2006-10-05 2008-04-11 Stephane Nouveau Dispositif de detection et de suivi d'une lesion du ligament croise anterieur (l.c.a.) du genou.
FR2906706A1 (fr) * 2006-10-05 2008-04-11 Stephane Nouveau Dispositif de detection et de suivi d'une lesion du ligament croise anterieur (l.c.a.) du genou.
US20120226199A1 (en) * 2009-10-22 2012-09-06 Genourob The device for detecting and following up a complete or partial anterior cruciate ligament injury by means of comparing the two limbs

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4913163A (en) * 1986-03-27 1990-04-03 Roger Gregory J Measurement of laxity of anterior cruciate ligament
US5156163A (en) * 1991-04-26 1992-10-20 Medmetric Corporation Patella displacement measuring device
US5335674A (en) * 1991-08-01 1994-08-09 Drexel University Apparatus and method for determining load-displacement and flexibility characteristics of a joint
US5348025A (en) * 1993-02-22 1994-09-20 Yale University Apparatus and method for measuring mobility of the scaphoid

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4913163A (en) * 1986-03-27 1990-04-03 Roger Gregory J Measurement of laxity of anterior cruciate ligament
US5156163A (en) * 1991-04-26 1992-10-20 Medmetric Corporation Patella displacement measuring device
US5335674A (en) * 1991-08-01 1994-08-09 Drexel University Apparatus and method for determining load-displacement and flexibility characteristics of a joint
US5348025A (en) * 1993-02-22 1994-09-20 Yale University Apparatus and method for measuring mobility of the scaphoid

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008040790A1 (fr) * 2006-10-05 2008-04-10 Genourob Dispositif de detection et de suivi d'une lesion du ligament croise anterieur du genou
FR2906699A1 (fr) * 2006-10-05 2008-04-11 Stephane Nouveau Dispositif de detection et de suivi d'une lesion du ligament croise anterieur (l.c.a.) du genou.
FR2906706A1 (fr) * 2006-10-05 2008-04-11 Stephane Nouveau Dispositif de detection et de suivi d'une lesion du ligament croise anterieur (l.c.a.) du genou.
US20120226199A1 (en) * 2009-10-22 2012-09-06 Genourob The device for detecting and following up a complete or partial anterior cruciate ligament injury by means of comparing the two limbs

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Publication number Publication date
AU2001250758A1 (en) 2002-05-21

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