WO1996036278A1 - An orthopedic device supporting two or more treatment systems and associated methods - Google Patents

An orthopedic device supporting two or more treatment systems and associated methods Download PDF

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Publication number
WO1996036278A1
WO1996036278A1 PCT/US1996/007047 US9607047W WO9636278A1 WO 1996036278 A1 WO1996036278 A1 WO 1996036278A1 US 9607047 W US9607047 W US 9607047W WO 9636278 A1 WO9636278 A1 WO 9636278A1
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WIPO (PCT)
Prior art keywords
treatment
control unit
means
orthopedic
support structure
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Application number
PCT/US1996/007047
Other languages
French (fr)
Inventor
John G Stark
Original Assignee
John G Stark
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Publication date
Priority to US44294595A priority Critical
Priority to US08/442,945 priority
Application filed by John G Stark filed Critical John G Stark
Publication of WO1996036278A1 publication Critical patent/WO1996036278A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A63SPORTS; GAMES; AMUSEMENTS
    • A63BAPPARATUS FOR PHYSICAL TRAINING, GYMNASTICS, SWIMMING, CLIMBING, OR FENCING; BALL GAMES; TRAINING EQUIPMENT
    • A63B21/00Exercising apparatus for developing or strengthening the muscles or joints of the body by working against a counterforce, with or without measuring devices
    • A63B21/005Exercising apparatus for developing or strengthening the muscles or joints of the body by working against a counterforce, with or without measuring devices using electromagnetic or electric force-resisters
    • A63B21/0057Exercising apparatus for developing or strengthening the muscles or joints of the body by working against a counterforce, with or without measuring devices using electromagnetic or electric force-resisters using electromagnetic clutches
    • AHUMAN NECESSITIES
    • A63SPORTS; GAMES; AMUSEMENTS
    • A63BAPPARATUS FOR PHYSICAL TRAINING, GYMNASTICS, SWIMMING, CLIMBING, OR FENCING; BALL GAMES; TRAINING EQUIPMENT
    • A63B24/00Electric or electronic controls for exercising apparatus of preceding groups; Controlling or monitoring of exercises, sportive games, training or athletic performances
    • GPHYSICS
    • G06COMPUTING; CALCULATING; COUNTING
    • G06FELECTRIC DIGITAL DATA PROCESSING
    • G06F19/00Digital computing or data processing equipment or methods, specially adapted for specific applications
    • G06F19/30Medical informatics, i.e. computer-based analysis or dissemination of patient or disease data
    • G06F19/34Computer-assisted medical diagnosis or treatment, e.g. computerised prescription or delivery of medication or diets, computerised local control of medical devices, medical expert systems or telemedicine
    • G06F19/3481Computer-assisted prescription or delivery of treatment by physical action, e.g. surgery or physical exercise
    • AHUMAN NECESSITIES
    • A63SPORTS; GAMES; AMUSEMENTS
    • A63BAPPARATUS FOR PHYSICAL TRAINING, GYMNASTICS, SWIMMING, CLIMBING, OR FENCING; BALL GAMES; TRAINING EQUIPMENT
    • A63B21/00Exercising apparatus for developing or strengthening the muscles or joints of the body by working against a counterforce, with or without measuring devices
    • A63B21/002Exercising apparatus for developing or strengthening the muscles or joints of the body by working against a counterforce, with or without measuring devices isometric or isokinetic, i.e. substantial force variation without substantial muscle motion or wherein the speed of the motion is independent of the force applied by the user
    • A63B21/0023Exercising apparatus for developing or strengthening the muscles or joints of the body by working against a counterforce, with or without measuring devices isometric or isokinetic, i.e. substantial force variation without substantial muscle motion or wherein the speed of the motion is independent of the force applied by the user for isometric exercising, i.e. substantial force variation without substantial muscle motion
    • AHUMAN NECESSITIES
    • A63SPORTS; GAMES; AMUSEMENTS
    • A63BAPPARATUS FOR PHYSICAL TRAINING, GYMNASTICS, SWIMMING, CLIMBING, OR FENCING; BALL GAMES; TRAINING EQUIPMENT
    • A63B21/00Exercising apparatus for developing or strengthening the muscles or joints of the body by working against a counterforce, with or without measuring devices
    • A63B21/005Exercising apparatus for developing or strengthening the muscles or joints of the body by working against a counterforce, with or without measuring devices using electromagnetic or electric force-resisters
    • A63B21/0056Exercising apparatus for developing or strengthening the muscles or joints of the body by working against a counterforce, with or without measuring devices using electromagnetic or electric force-resisters using electromagnetically-controlled friction, e.g. magnetic particle brakes
    • AHUMAN NECESSITIES
    • A63SPORTS; GAMES; AMUSEMENTS
    • A63BAPPARATUS FOR PHYSICAL TRAINING, GYMNASTICS, SWIMMING, CLIMBING, OR FENCING; BALL GAMES; TRAINING EQUIPMENT
    • A63B2213/00Exercising combined with therapy
    • A63B2213/001Exercising combined with therapy with radiation therapy
    • AHUMAN NECESSITIES
    • A63SPORTS; GAMES; AMUSEMENTS
    • A63BAPPARATUS FOR PHYSICAL TRAINING, GYMNASTICS, SWIMMING, CLIMBING, OR FENCING; BALL GAMES; TRAINING EQUIPMENT
    • A63B2213/00Exercising combined with therapy
    • A63B2213/004Exercising combined with therapy with electrotherapy
    • AHUMAN NECESSITIES
    • A63SPORTS; GAMES; AMUSEMENTS
    • A63BAPPARATUS FOR PHYSICAL TRAINING, GYMNASTICS, SWIMMING, CLIMBING, OR FENCING; BALL GAMES; TRAINING EQUIPMENT
    • A63B2213/00Exercising combined with therapy
    • A63B2213/008Exercising combined with therapy combined with ultrasound therapy
    • AHUMAN NECESSITIES
    • A63SPORTS; GAMES; AMUSEMENTS
    • A63BAPPARATUS FOR PHYSICAL TRAINING, GYMNASTICS, SWIMMING, CLIMBING, OR FENCING; BALL GAMES; TRAINING EQUIPMENT
    • A63B2220/00Measuring of physical parameters relating to sporting activity
    • A63B2220/10Positions
    • A63B2220/16Angular positions
    • AHUMAN NECESSITIES
    • A63SPORTS; GAMES; AMUSEMENTS
    • A63BAPPARATUS FOR PHYSICAL TRAINING, GYMNASTICS, SWIMMING, CLIMBING, OR FENCING; BALL GAMES; TRAINING EQUIPMENT
    • A63B2220/00Measuring of physical parameters relating to sporting activity
    • A63B2220/50Force related parameters
    • A63B2220/54Torque
    • AHUMAN NECESSITIES
    • A63SPORTS; GAMES; AMUSEMENTS
    • A63BAPPARATUS FOR PHYSICAL TRAINING, GYMNASTICS, SWIMMING, CLIMBING, OR FENCING; BALL GAMES; TRAINING EQUIPMENT
    • A63B23/00Exercising apparatus specially adapted for particular parts of the body
    • A63B23/035Exercising apparatus specially adapted for particular parts of the body for limbs, i.e. upper or lower limbs, e.g. simultaneously
    • A63B23/04Exercising apparatus specially adapted for particular parts of the body for limbs, i.e. upper or lower limbs, e.g. simultaneously for lower limbs
    • A63B23/0494Exercising apparatus specially adapted for particular parts of the body for limbs, i.e. upper or lower limbs, e.g. simultaneously for lower limbs primarily by articulating the knee joints

Abstract

An orthopedic restraining device (100) controls and monitors two functionally distinct orthopedic treatments through a portable, programmable control unit (106). The functionally distinct treatments are selected from exercise based treatments and treatments based on energy propagating transducers. The exercise based treatment structures can be isometric exercise structures or non-isometric based treatment structures. The energy propagating transducer based treatment structures include ultrasonic transducer based treatment structures, pulsed electromagnetic treatment structures, and electrical conduction based treatment structures. An alternative device incorporates a hinge (116) on a support structure (108) for non-isometric exercise where the resistance or range in the hinge (116) can be controlled by electrical signals from a control unit (106). The invention gives a physician the power to design an entire treatment program for a patient using a variety of treatment methods coordinated and monitored through a control unit. The invention integrates the control of each of the selected treatments to optimize treatment results.

Description

AN ORTHOPEDIC DEVICE SUPPORTING TWO OR MORE TREATMENT SYSTEMS AND ASSOCIATED METHODS

FIELD OF THE INVENTION The invention relates to monitored orthopedic treatment devices. More specifically, the invention relates to an intelligent orthopedic brace that allows a selection of treatments including monitored exercise programs and treatments using various energy propagating transducers.

BACKGROUND OF THE INVENTION

It is known that both muscles and bones should be exercised to maintain strength. It is also known that fractures exposed to permissible weight bearing stress often heal more predictably and more rapidly than fractures which are not stressed at all. This is also believed true for connective tissue, such as ligaments and certain cartilage.

It is now also known that the application of certain types of energy to an injured area can, in the proper circumstances, promote healing of muscle, bone or connective tissue. The various applied energies include ultrasound, electromagnetic fields and electric currents. Certain treatment systems, summarized below, have been developed to make use of treatments based on exercise and for treatment using energy propagating transducers.

Two general types of intelligent

(microprocessor controlled) orthopedic braces have been developed to assist and monitor the exercise program of a patient. These braces are generally designed to be worn around a limb, joint or series of joints, such as the knee, elbow, ankle, wrist, shoulder, neck, waist, or other area of the patient. The braces differ, for example, in whether they are designed to assist with isometric exercises where the joint is held fixed during the exercise or whether they are designed to assist with nonisometric exercises such as an exercise involving a patient's active flexing of the joint. U.S. Patents Nos. 5, 052, 375 and 5, 368,546 (both to Stark et al. ) each disclose an intelligent brace designed to monitor and assist with the performance of isometric exercises. The brace preferably has a rigid frame with one or more stress sensors attached. Certain embodiments of the brace have a hinge connecting two portions of the rigid frame. The hinge will be locked during the exercise routine but will allow adjustment of the angle of the hinge to allow exercise at selected angles of the patient's joint. Other embodiments have an incrementally adjustable electromechanical hinge with a potentiometer mechanism to measure the angular orientation, and a brake and/or clutch mechanism to allow for selective adjustment of the angular orientation. The potentiometer mechanism can be used to monitor the range of motion accessible to the patient as healing progresses.

The brace has a control unit, preferably including a microprocessor, connected to the stress sensors and to the electromechanical hinge (if present) . The control unit can serve a variety of purposes in assisting the patient with their exercise program. Minimally, the control unit should provide feedback to the patient, usually through a display, to indicate if appropriate levels of stress are being applied. The control unit should also have a memory device to store the stress measurements to allow later analysis. The control unit can be programmed to alert the patient when it is time to perform exercises and when the exercises have been performed for a sufficient amount of time. The control unit may also allow communication of the exercise results either nearby or at long distances. For example, an output port on the control unit can be electrically connected to a printer/plotter, an external storage device, a modem or another computer. Similarly, the control unit can be attached to a transmitter that provides wireless communication with a receiver at a monitoring station located nearby. A more powerful transmitter can be used to transmit the stress readings over longer distances, such as from the patient's home to the physician's office. The communication of the stress results allows a physician or other health care provider to monitor the progress of the exercise program either contemporaneously with the exercise or at a later time. The stress measurements can be analyzed to allow for adjustments to the exercise program.

The brace enhances the patient's ability to receive the support, control and motivation needed for an extensive program of rehabilitative treatment. The process of strengthening the extremities is an essential element in that treatment. Strengthening the damaged or diseased extremity, when it can be achieved, is a safe and normally effective way of improving function. The conventional monitored physical therapy programs often work because of the intense coaching and supportive environment in which the physical therapy occurs. The use of an intelligent brace can, such as shown in the above referenced patents, reproduce some of the characteristics of a monitored physical therapy program without the attendant cost, personnel time and inconvenience.

While the isometric method, which is primarily employed by the brace described above, has both advantages and disadvantages, strengthening programs using isometric means have been demonstrated to provide valuable and predictable strengthening effects. These effects are often very specific to individual conditioning or individual body structure. The isometric method may be considered an adjunct or, in certain cases, the only possible exercise method in light of the particular damage, disease or other changes. For example, patients can generate their maximum torque with isometric exercises. However, the greatest advantage of isometric exercise is likely that the injured or diseased extremity can be strengthened in the absence of motion, preferably resulting in less pain and less tissue damage. With appropriate modifications, isometric exercises could be used to obtain results which begin to approximate the results generally obtained with isokinetic exercises in certain situations when isokinetic exercises are not possible. U.S. Patent 5,052,379 (Airy et al. ) , entitled

Combination Brace and Wearable Exercise Apparatus for Body Joints, describes an alternative type of orthopedic brace (referred to below as the Airy brace) for monitored exercise. The Airy brace is designed to stabilize a limb, to allow a limited range of motion along one angle defined by a hinge, and to exercise a joint through resistive bending at the joint. The Airy brace has a frame with pivot arms connected by a mechanical hinge. The angular range of motion of the hinge is controlled by a control plate together with moveable stops. These stops provide mechanical restrictions on the range of motion of the hinge.

Various resistance units can be used to supply resistance to the angular motion to allow controlled exercise of the patient. A measurement unit can be supplied to measure various parameters including the range of motion of the body joint, the speed at which the body joint is flexed and extended, and the torque being exerted by the body joint when articulating the frame. The Airy brace has the disadvantage that the amount of resistance is fixed and cannot be controlled electrically, although replaceable resistance units allow for the adjustment of the resistance.

Typically, the recovery process for an injured body joint requires that the joint be held immobile for a period of time after the injury or following surgery. After a period of time the joint is then allowed to move through a controlled, limited degree of rotation about the joint. The treatment will often include rotating the joint through a controlled range of motion against a selected amount of resistance. The range of motion and amount of resistance would usually be increased over time.

The braces referred to above are probably most appropriate for use at different points of time in the treatment process of a particular injury. For example, one brace might be most suitable soon after the injury while another brace may be more suitable after some healing has already taken place. The use of both braces would require the switching of braces at some point and might not easily allow a gradual transition from one type of exercise to another.

Turning to energy propagating transducer based treatments, U. S. Patent 5,003,965 (Talish et al . ) , entitled Medical Device for Ultrasonic Treatment of Living Tissue and/or Cells, describes the use of an ultrasonic transducer for the non-invasive treatment of bone fractures, pseudarthroses, and similar injuries. An ultrasonic transducer produces sound waves in a frequency range between 100 Hertz (Hz) and 1000 Hz. The transducer is part of a treatment head that is mounted onto an orthopedic support. A portable remote control unit provides electrical connections to the treatment head. The treatment head has a power supply for the production of the ultrasonic waves. Control pulses are sent by the remote control unit over a fiber optic cable to signal the treatment head when to apply the ultrasonic waves.

An article by J. D. Heckman, M.D. et al. , at 76A Journal of Bone and Joint Surgery 26-34 (1994) , entitled Acceleration of Tibial Fracture-Healing by Non-Invasive, Low Intensity Pulsed Ultrasound, describes the therapeutic effects of low-energy ultrasound. While different medical applications of ultrasound use energy ranges from 5 milliwatts per square centimeter to 300 watts per square centimeter, the therapeutic treatment described in the Heckman manuscript used low energy ultrasound averaging 30 milliwatts per square centimeter. The treatment head produced sonic pulses of 200 microseconds at a frequency of 1.5 megahertz and a repetition rate of one kilohertz . Treatment was started within seven days of a fracture and consisted of one 20 minute treatment each day. Treatment was continued for 20 days or until the injury was sufficiently healed to end treatment. The treatment with ultrasound resulted in significantly shortened recovery time for a group of patients using the ultrasonic treatments compared with a group using a placebo device that did not apply the sonic waves.

U.S. Patent 5,195,941 (Erickson et al . ) , entitled Contoured Triangular Transducer System for PEMF Therapy, and U.S. Patents 5,269,747 and 5,181,902 (Erickson et al.), both entitled Double-Transducer System for PEMF Therapy, each describe the use of two coil transducers to produce pulsed electromagnetic fields (PEMF) useful for the treatment of resistant problems of the musculo-skeletal system. Noted problems to be treated with PEMF include spinal fusion, united fractures, failed arthrodeses, osteonecrosis, chronic refractory tendinitis, decubitus ulcers, ligament injuries, tendon injuries, osteoporosis and Charcot foot. The coils referred to in the 5,195,941 patent are wound flat and are encapsulated in a semi-rigid shell. The transducer includes two primary windings with about 7 turns each, a secondary winding with about 35 turns and a sense winding with at least one turn. The secondary windings provide energy recovery and assistance in tailoring the electromagnetic field. A control unit controls and monitors the PEMF transducer.

A publication by V. Mooney, M.D., at 15 Spine 708-712 (1990) , entitled A Randomized Double-Blind Prospective Study of the Efficacy of Pulsed Electromagnetic Fields for Interbody Lumbar Fusions, presents clinical results demonstrating the effectiveness of PEMF for treating interbody lumbar fusions. The patients in the active, i.e., non-control group, wore electromagnetic braces with either a single coil (1.8 gauss) or a double coil (4 gauss) The braces also monitored use by the patient . Inconsistent use was defined as less than 8 hours per day. The use of the PEMF improved chances for healing, and patients using the double coil brace had greater success rates than patients wearing the single coil braces. Electrical current has also been applied for healing purposes, both to stimulate bone growth and to strengthen muscles. U.S. Patent 5,304,210 to D. F. Crook, entitled Apparatus for Distributed Bone Growth Stimulation, discloses an apparatus for supplying electrical stimulation to aid in the healing of bones. A cage is mounted on the individual's body directly against the injury site. The apparatus can be further equipped to take resistance readings of the tissue which reflects the progress of bone growth. An integral frame supplies pressure to stabilize the injury site. A conductive mesh can be attached to the frame. It is contemplated that the frame would be directly attached to the underlying bone structure requiring surgery. European Patent Application Publication No. 561,068 (Erickson et al. ) , entitled Implantable Bone Growth Stimulator and Method of Operation, describes an electrical bone growth stimulator that has implantable electrodes that are easily replaced and completely removable. The implantability is described as advantageous in terms of preventing damage to the device and ensuring patient compliance. The device can be designed for use with either alternating current (AC) or direct current (DC) . The AC current, when used, produces a field strength between 0.3 millivolts/centimeter (mV/cm) to 3 mV/cm. The DC current, when used, is supplied at 20μA. The device is designed to be programmable and to enable conventional wireless communication with external devices for monitoring of the treatment.

The publication by L. Snyder-Mackler et al. , at 73A Journal of Bone and Joint Surgery 1025-1036 (1991) , entitled Electrical Stimulation of the Thigh Muscles After Reconstruction of the Anterior Cruciate Ligament, reports on the use of electrical stimulation to promote muscle strengthening. The patients were divided into two groups, one that used electrical stimulation and exercise and a second that just used exercise alone. Patients were treated for 3 days a week during the third through sixth post-operative week The electrical stimulation was provided with 75 pulses per second of 400 microseconds per pulse. The electrical energy was supplied at a 2500 hertz frequency. The pulse train was turned on for 15 seconds followed by 50 seconds with the pulse train turned off, with this cycle being used for a maximum of fifteen "on periods" per session. The amplitude of the current was generally increased during the course of a session. The clinical results demonstrated that the patients that received the neuromuscular stimulation had increased muscular strength and improved functional use of the muscles.

A later study by L. Snyder-Mackler et al. , at 74 Physical Therapy 901, 907 (1994), entitled Use of Electrical Stimulation to Enhance Recovery of Quadriceps Femoris Muscle Force Production in Patients Following Anterior Cruciate Ligament Reconstruction, compared treatment with electrical stimulation at a patient's home using a portable device with treatment in a clinical setting. The study concluded that the treatments in the clinical setting were more effective than in the home setting. The advantages of the clinical setting could not be attributed to the current levels of the different stimulators since the current levels were comparable and were actually higher for the home setting, i.e., 83 mA

(home) versus 55 mA (clinic) . The differences were attributable to the different muscle contractions that resulted from a particular applied electrical stimulation. One hypothetical explanation attributed the worse results obtained by the treatments at home to the lack of equipment for stabilizing the limbs.

These descriptions of orthopedic treatment systems should be considered representative and not in any way complete.

SUMMARY OF THE INVENTION The improved orthopedic device of the present invention will have structures providing at least two functionally distinct treatments. The functionally distinct treatments will be either one exercise treatment means with one energy propagating transducer based treatment structure, two functionally distinct energy propagating transducer based orthopedic treatment structures or a monitored resistive non-isometric exercise means with a monitored isometric exercise means. Also, these distinct treatments will be controlled and monitored by a portable, programmable control unit. Structures associated with the orthopedic device appropriate for exercise treatment include monitored isometric exercise structures and monitored nonisometric exercise structures. Energy transducer based treatment structures include ultrasonic treatment structures, pulsed electromagnetic treatment structures and electrical conduction based treatment structures and electrical conduction treatment structures.

Another orthopedic treatment device within the present invention includes a support structure for restraining flexibly connected body portions of the patient, a hinge between two portions of the support structure, a portable, programmable control unit, and resistance means operably connected to the control unit such that an electrical signal from the control unit determines the resistance in the hinge. The hinge defines an angular position of one portion of the support structure relative to a second portion of the support structure, where the first portion of the support structure supports a flexibly connected body portion of the patient and the second portion of the support structure supports a second flexibly connected body portion of the patient.

An orthopedic treatment method of the present invention includes the steps of connecting an orthopedic treatment device to an individual user in the vicinity of a musculo-skeletal injury and configuring the treatment to utilize at least two functionally distinct treatment protocol means. Again, these functionally distinct treatment protocol means will be either one exercise treatment means with one energy propagating transducer based treatment structure, two functionally distinct energy propagating transducer based orthopedic treatment structures or a monitored resistive non-isometric exercise means with a monitored isometric exercise means. Within this treatment method, the treatment device has a portable, programmable control unit operably connected to the at least two functionally distinct treatment structures.

An alternative treatment method of the present invention includes the steps of evaluating the condition of the patient, developing a treatment strategy based on two or more distinct treatment methods, as described above, that can be controlled and monitored by a control unit, configuring an orthopedic treatment device to implement the treatment strategy, programming the control unit based on the treatment strategy, connecting the orthopedic treatment device on the patient, and activating the control unit. The alternative method can further include the steps of monitoring the progress of the treatment, evaluating the treatment strategy based on the monitored results and modifying the treatment strategy, if appropriate.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a schematic representation of the invention showing the relationship between the control unit and various possible treatment systems;

Figure 2 is a side view of an orthopedic treatment device in accordance with the present invention; Figure 3 is a schematic illustration of elements of an orthopedic treatment device of Figure 2;

Figure 4 is a perspective view of a patient's leg with a support structure having an articulating hinge;

Figure 5 is a side view of a patient's torso with an articulating support structure around their abdomen;

Figure 6 is a sectional view of an electromagnetic hinge taken along line 6-6 of Figure 3; Figure 7 is a sectional view of an electromagnetic hinge taken along line 7-7 of Figure 6;

Figure 8 is a perspective view of an ultrasonic transducer including a mount; Figure 9 is a fragmentary sectional view of the treatment head of the ultrasonic transducer of Figure 8 which includes the central axis of the transducer and its support, the section half above the central axis and the section half below the central axis, taken in separate orthogonally related planes which intersect along the central axis;

Figure 10 is a block diagram schematically depicting the electronics within the treatment head of the ultrasonic transducer of Figure 8; Figure 11 is a perspective view of a PEMF transducer;

Figure 12 is a sectional view of the PEMF transducer of Figure 11 taken along line 12-12;

Figure 13 is a schematic illustration of the electrical connections within the PEMF transducer;

Figure 14 is a partially cut away, perspective view of an H-shaped conduction transducer;

Figure 15 is a perspective view of an implantable conduction transducer; Figure 16 is a perspective view of a partially completed conduction transducer of Figure 15;

Figure 17 is a block diagram schematically indicating the electronic components of the implantable conduction transducer of Figure 15; Figure 18 is a top view of two muscle stimulation electrodes;

Figure 19 is a bottom view of a muscle stimulation electrode;

Figure 20 is a schematic representation of an alternative embodiment of a control unit; Figure 21 is a schematic representation of a second alternative embodiment of the control unit;

Figure 22 is a block diagram schematically depicting one embodiment of the electronic components of the control unit; and

Figure 23 is a flow diagram depicting the general procedure for treatment using the present invention.

The figures, which are idealized, are not to scale and are intended to be merely illustrative and non-limiting.

DETAILED DESCRIPTION OF THE INVENTION

A physician is often faced with a choice among several known treatments for orthopedic or related injuries. However, the use of multiple orthopedic treatment types during the course of treatment would require additional trips by the patient to the physician, or vice versa, along with increased costs associated with the coordination required of the physician. The use of several of these treatments simultaneously, using known treatment modalities, is likely quite difficult and in many cases impossible. The challenge resides in cost and the coordination of the treatments, as well as the amount of training that would be required of the patient, the patient's family, and any allied healthcare professional. Moreover, the lack of recognition of such possibilities has resulted in an absence of devices capable of performing such combined treatments.

Improved treatment in a more cost effective way would be provided if the treatments could be coordinated to allow simultaneous or sequential treatment using several different treatment types with the overall regimen tailored to a particular patient without burdensome follow-on attendance by a physician. Such an improved treatment system would provide convenient ways for both the patient and the physician to monitor the progress of the treatments and promptly modify the treatments accordingly to optimize treatment according to patient response. This improved treatment system could have a single central control unit programmed to monitor and control any or all of the available exercise or energy transducer based treatments.

Several exercise based and energy propagating transduction based therapy systems are now known to enhance the healing of injured bone and/or muscle tissue. While these systems can be somewhat advantageously used individually, the present invention dramatically alters their use and contribution to patient care by coordinating and integrating the treatment techniques in a personalized treatment program according to each particular patient's needs. A physician designed treatment program based on several simultaneous or sequential treatment techniques is more efficient and more effective for patient care and recovery. In many cases, novel combinations of treatment may directly accelerate the patient's recovery. For example, as noted above, the electrical stimulation of muscles in a home environment has been found to be not as advantageous as in the clinical setting because the limbs are not adequately supported. However, use of such stimulation in combination with the innovative braces designed for exercise based therapy will provide the support necessary, as well as provide measurements of the contractive forces being applied to allow better monitoring of the home based electrical stimulation treatments. Another example of the impact of this invention on patient care is the opportunity to now permit a gradual transition from isometric exercises to non-isometric exercises without the need to switch between two or more different types of braces. Generally, though, the most significant advantages of the present invention are found in the improved flexibility in the design of treatment, the increased efficiency and efficacy of allowing the physician to design a comprehensive treatment program, and the efficient monitoring of that program. A treatment program can be designed for the entire treatment period which can be modified based on monitored results.

The preferred embodiments of the present invention allow for the optional use of a variety of different treatment methods. The physician will select the treatment methods from a group of treatments including those based on controlled and monitored exercise and those which use energy propagating transducers to direct appropriate energy to the damaged region to stimulate healing. The exercise treatments include isometric exercise methods and nonisometric exercise methods such as those based on controlled flexing about a joint. Both of these exercise methods use a brace around the joint near the injury. The energy propagating transducer based treatments include ultrasonic treatments, pulsed electromagnetic treatments and electrical conductance treatments. While various mechanical embodiments of the invention are possible, the following examples of structure are useful for disclosing certain possible embodiments of the invention.

Generally, the treatment apparatus 100 for practicing the present invention includes a control unit 106 to control, coordinate and monitor the treatments and the necessary structures to practice the particular selected treatment methods. The treatment apparatus 100 of one embodiment will allow a selection from all of the above described treatments. The schematic relationship in apparatus 100 between the various treatment means is displayed in Figure 1. The treatment means are discussed in more detail below. Such an apparatus is representatively shown in Figure 2, where the apparatus 100 is set up for treatment of an injury near the knee 102 of patient 104. Appropriate modification to adapt the apparatus for other joints such as an ankle, neck, elbow, wrist, shoulder, back or pelvis are straightforward based on this disclosure.

Referring to Figures 2 and 3, the treatment apparatus 100 includes a control unit 106 and various structures that are designed for appropriate treatment methods. Since the preferred embodiments allow for a selection from a variety of treatment methods, the apparatus 100 will include a support structure 108 or brace that is required for the exercise treatments and that therefore form part of the isometric exercise means 109 and the nonisometric exercise means 111. The support structure 108 can include a frame 110 comprised of a left restraining portion 112 and right restraining portion 114 and hinges 116. Each restraining portion 112, 114 of the frame 110 includes a first and second distal end section, 118 and 120 respectively. In this particular embodiment, strain gauges 122 are attached to the restraining portions 112, 114.

The restraining portions 112, 114 can be constructed of various rigid materials including steel, aluminum, and other metals and alloys. The preferred materials for the restraining portions 112, 114 may be selected from non-metals or more specifically non-conductors to avoid interference with the performance of the energy propagating transducers. Some appropriate materials for restraining portions 112, 114 include, but are not limited to, fiberglass, composites, and similar materials.

The frame 110 can be replaced by other types of support structures 108 that cover varying portions of the injured part of the person's body. For example, the support structure 108 can surround the entire circumference of a portion of a limb or body part. A hinge may comprise virtually any structure that allows relative motion of two parts of a support structure 108. Certain portions of the patient's body may be particularly suitable for the use of more particularized support structures and hinges. For example, a human knee is a cam structure rather than a simple hinge pivoting about a single point. Therefore, as shown in Figure 4, better support can be provided with a support structure 121 surrounding the leg and having an articulating hinge 123 between the parts 125, 127 of the support structure on either side of the knee. Stress sensors 122 can be built into the support structure. Other particularized articulated support structures would be appropriate for supporting a back injury. One such support structure 129 is schematically shown in Figure 5 with articulating hinge 131.

While the support structure 108 is required for the exercise treatments, it can also prove beneficial in the energy propagating transducer based treatments either directly by supporting the energy transducers or indirectly by stabilizing the portion of the limb being treated. The exact design of the support structure 108 can incorporate appropriate features to coordinate with the other components. The apparatus 100 in Figure 2 includes optional combinations of treatment methods including ultrasonic transducer 124, pulsed electromagnetic field transducer 126, implantable electrical current transducer 128 for bone healing stimulation, surface contact electrical current transducer 130 for bone healing stimulation, and electrical muscle contraction stimulator 132. Referring to Figure 3, in one embodiment, each restraining portion 112, 114 is supplied with two strain gauges 122 for a total of four strain gauges 122. One possible position for the strain gauges is shown. The two strain gauges 122 on a particular restraining portion 112, 114 are attached on opposite edges of the restraining portion 112, 114. The strain gauges 122 can be foil type strain gauges. The strain gauges 122 are electrically connected with control unit 106 by way of strain gauge wire 134.

Many possible constructions are possible for hinges 116, 123 and 131. One construction of hinges 116 involves electromechanical hinges, shown in Figures 3, 6 and 7. One electromechanical hinge 116 is secured to the first and second distal end portions 118, 120 of each restraining portion 112, 114. The second distal end portion 120 includes as an integral unit a first, second and third shouldered pin or bolt segments 136, 138, 140. Electromechanical hinge 116 includes a clutch housing 142 which is secured to the first distal end portion 118. The first distal end portion turns around the shoulder pin segment 138. The end of the second shouldered pin segment 138 has exterior threads 144 for receiving nut 146 for securing the first distal end portion 118 to the second distal end portion 120. The nut 146 secures a washer 148 against the first distal end portion 118 such that the first distal end portion 118 can turn freely about the second shouldered pin segment 138 when the hinge 116 is permitted to turn by the electromechanical brake/clutch. The third shouldered pin segment 140 passes through an opening (not shown) in the magnetically attractable armature 150. The armature 150 includes a spline 152 which fits into an armature groove 154 for receiving the spline 152, located in the third shouldered pin segment 140, so that the armature 150 will only turn in a rotary movement with the shouldered pin segments 136, 138, 140. A threaded arm 156 extends from the third shouldered pin segment 140. The boundary between the threaded arm 156 and the third shouldered pin segment 140 form a shoulder against which a wiper arm 158 is secured. The exterior threads of the threaded arm 156 receive a second nut 160 which secures the wiper arm 158 against third shouldered pin segment 140.

The threaded arm 156 includes a flat side 161 which provides a key to turn a molded insulating element portion 162 of the wiper arm 158. The insulating element portion 162 is bonded to the conductive element 164 of wiper arm 158. The insulating element 162 is made of suitable polymeric material which insulates the third shouldered pin segment 140 from the electrical current that normally flows through the conductive element 164 of the wiper arm 158.

Since the wiper arm 158 is keyed to the threaded arm 156, the wiper arm 158 turns in a common rotary movement with the threaded arm 156 and all of the shouldered pin segments 136, 138, 140. As the wiper arm 158 turns, conductive element 164 remains in contact with a contact arm 166 which is connected to a first lead 168 which is in turn electrically connected to control unit 106. The second lead 170 is connected to a resistive slide line element 172 and also with control unit 106. The electrical connection of the conductive element 164 with the resistive slide element 172 forms a potentiometer-like mechanism 174 that is electrically connected to control unit 106 to provide an output to the control unit 106 which can be calibrated to indicate the relative position of the contact point between the resistive slide line element 172 and the wiper arm 158, and, therefore, the angle between the respective distal end portions 118, 120 of the restraining portions 112, 114. The electromechanical hinge 116 includes an electromechanical brake/clutch mechanism 176 similar to those which are standard in the art. The preferred electromechanical clutch mechanism 176 is interconnected with control unit 106 with wires extending from clutch lead 178. Clutch lead 178 is electrically connected with a stator coil 180 within stator housing 182 which is designed to attract armature 150 when a sufficient magnetic field is created by the electric current passing through the stator coil 180, thereby preventing the armature 150 from turning with respect to the stator coil 180. The current may be derived from a source of electricity within the control unit 106. Separate wires or connectors connect control unit 106 to the potentiometer-like mechanism 174. The electromechanical break/clutch mechanism

176 of the electromechanical hinge 116 can be controlled by either pushing a release or a brake button (not shown) on the control unit 106 which will respectively free the armature 150 to turn with respect to the stator coil 180 or by the response of the control unit 106 according to its program. When the release button is pushed, the armature 150 is free to turn with respect to the stator coil 180 and the angle between the respective distal end portions 118, 120 may be manually adjusted. In some embodiments, the change of the angle between the respective distal end portions 118, 120 can be monitored by watching a readout display (not shown) on the control unit 106 as the angle is adjusted. When the angle reaches the desired angle, the brake may be applied by again pushing the brake button, wherein a circuit is completed allowing an electrical current to pass through the stator coil 180, thereby creating a magnetic field which arrests the armature 150 and prevents the armature 150 from turning with respect to the coil 180. Referring to Figure 6, when the armature 150 is attracted to the coil 180, a pair of free riding annular disks 184, 186 are gripped between the armature 150 and a stator housing 182 within the clutch housing 188. The outer annular disk 186 is preferably made of a suitable metal and the inner annular disk 184 is preferably made of a suitable polymeric material to provide for a smooth gripping between the surfaces and prevent wear between them. The free riding disks 184, 186 encircle a center portion of the armature 150. A coil spring 190 biases the armature 150 away from stator housing 182 when the magnetic attraction between the coil 180 and the armature 150 is insufficient to overcome the mechanical force of the coil spring 190 which biases the armature 150 away from the stator housing 182.

In certain embodiments of the invention, the electromechanical brake/clutch mechanism 176 is controlled by a microprocessor (for example as shown in Figure 22) in the control unit 106. Generally, the hinge is locked at certain positions during periods of isometric exercises. After a specified number of isometric repetitions, the control unit 106 will release the brake and allow the hinge to move until a new angle is reached when the brake is applied again to stop the rotation. Another set of isometric exercises will be performed at this new angle. In this manner an entire isometric exercise routine can be controlled by the control unit 106. The hinge can be locked between isometric exercise routines.

For performing nonisometric exercises, the control unit can supply a calibrated amount of current to the electromechanical brake mechanism 176 that is lower than the amount to lock the hinge 116 to provide a selected amount of resistance in the hinge 116. The control unit 106 can also selectively supply a greater amount of current to brake the hinge 116 to prevent motion outside of a certain angular range. In this way, the control unit 106 can control a flexing nonisometric exercise routine.

Other designs are possible for the hinge. The electromechanical hinge 116 can be designed to be locked when no current is flowing to the brake/clutch mechanism and unlocked when sufficient current is flowing. Alternatively, the resistance to rotation can be supplied by a highly viscous fluid preferably comprised of silicon, for example as shown in U.S. Patent 5,052,379. In addition, a fluid or fluids may be used which function to create a variable viscosity device which may vary according to an applied electric field or other means, so the resistance to rotation of the hinge 116 can be altered by the control unit 106. The locking mechanism can be electromechanical, electrical or mechanical. One mechanical locking mechanism would have engaging members that are tightened with a manual screwing mechanism rather than electrically controlled through the control unit 106.

Consistent with the present invention, the hinge may be any device that articulates between two portions of a support structure. The resistance between the relative motion of two portions of the support structure can be built into the hinge by any means either electronically controlled or not. For articulating hinges 123 and 131, resistance means can be built into space around the articulating portions of the hinge.

Referring to Figure 8, a representative ultrasonic transducer 124, such as one similar to that disclosed in U.S. Patent 5,003,965, includes a treatment head 200 and a mount 202. The treatment head 200 is connected to control unit 106 through cable 204. In one embodiment, cable 204 has two separately sheathed fiber-optic lines 206, 208. These fiber-optic lines 206, 208 can be replaced by electrical connections if desired. The treatment head 200 has a housing 210 integrally formed with a tubular projecting cylindrical wall 212 having a turned-in flange 214 at its outer end. Cupped shell 216 protrudes from the tubular wall 212. Projecting from housing 210 are studs 218 at diametrically opposite positions and actuator switch buttons 220 at 90* relative to studs 218. Studs 218 have grooves 222. Actuator switch buttons 220 project from local land formations 224 of housing 210. Mount 202 is generally rectangular and provides an outward flange 226 which extends peripherally around a truncated-pyramid wall 228. Truncated pyramidal wall 228 presents a truncated face 230. The center of truncated face 230 is characterized by an opening 232 defined by an integrally formed cylindrical flange 234 for insertional telescopic acceptance of the cylindrical wall 212 of treatment head 200. Truncated face 230 has two slots 236. These slots 236 open into two diametrically opposed enlargements 238. Treatment head 200 and mount 202 engage through a bayonet-type lock. Studs 218 can enter into enlargements 238 at corresponding ends of slots 236. Grooves 222 accommodate local mount 202 thickness at face 230. To engage the bayonet-lock, studs 218 are inserted into enlargements 238, and the treatment head 200 is rotated relative to the mount 202 to complete the engagement of studs 218 in slots 236. Land formations 224 of housing 210 ride up ramp slopes 237 on truncated face 230 to rest on surfaces 239 on truncated face 230. Engagement of the bayonet-lock causes the depression of buttons 220 which closes actuator switches 240. When actuator switches 240 are open, no power can be supplied to transducer 242.

Referring to Figure 9, transducer 242 is bonded to the inner surface of the closed end wall of cupped shell 216. Transducer 242 may be a commercially available piezoelectric ceramic disc that is constructed of, for example, the lead-zirconium-titanate material known as PZT-4. Transducer 24 includes a separate foil electrode (not shown) bonded to each of its front and back surfaces, to enable thickness fluctuations in response to driven excitation via connections 243. Cupped shell 216 has a base flange 244. An inner wall 246 is secured to shell 216. Inner wall 246 is spaced from transducer 242 and provides support for a cylindrical body of foamed plastic 248. The other end of the cylindrical body of foamed plastic 248 is supported by projecting wall 249. The cylindrical body of foamed plastic 248 provides softly yielding compliant suspension of shell 216.

An optional flexible plastic sleeve 250 is constructed of vinyl or silicone. The plastic sleeve 250 is circumferentially bonded to the outer rim of shell 216. Plastic sleeve 250 does not interfere with the bending of cup shell 216 relative to tubular wall 212 to orient the transducer 242 properly for use. Treatment head 200 has a circuit board 252 holding electrical components to drive the oscillator, as shown in Figure 9. Connections 243 lead from transducer 242 to circuit board 252. Figure 10 displays a schematic of the electrical components and appropriate electrical connections within treatment head 200. Opto receiver 256 and opto driver 258 are connected to fiber optics 206, 208, respectively, for communication with control unit 106. Treatment head 200 also contains an oscillator 260, signal monitoring means 262, fixture interlock means 264 and a battery 266 which serves as a power supply for the treatment head 200.

The opto receiver 256 can be a photodiode which receives control pulses via optical fiber 206 from control unit 106. The control pulses indicate whether oscillator 260 should be turned on or off corresponding to the on/off control of ultrasonic transducer 242. A connection 268 enables the signal monitoring means 262 to monitor the output of oscillator 260. The monitored signal is used by the signal monitoring means 262 to provide an output signal to opto driver 258, whereby the monitoring signal may be transmitted by way of fiber optic 208 back to control unit 106. Opto driver 258 may be a light emitting diode. A typical frequency for oscillator 260 is 1.5 MHz. The actual frequency used will be selected based on the property of the particular transducer 242.

While the above ultrasonic treatment head 200 provides one suitable design for an ultrasonic treatment device, other designs for ultrasonic treatment devices can be successfully used in the present invention. Generally, a gel 272, displayed in phantom lines in Figure 9, provides coupling between transducer 242 and adjacent body tissue. Insufficient coupling between transducer 242 and adjacent body tissue is detected by signal monitoring means 262, shown in Figure 10, which is communicated to control unit 106. At that point, the operation of treatment head 200 is turned off.

A representative pulsed electromagnetic field transducer 300, as disclosed in U.S. Patent 5,195,941, is shown in Figure 11. The PEMF transducer 300 is shaped to fit around a joint of the patient. The PEMF transducer 300 may be essentially triangular in shape with bends to allow for placement around the joint or injured body part. The triangle is defined by three angles 302, 304, 306 formed with three sides 308, 310, 312. Side 312 is bent out of the plane of the triangle to allow the transducer 300 to fit around the desired injured or treated body portion of the patient. Side 312 essentially crosses a portion of the patient's body near the joint with angles 302 and 304 on either side of the joint. Drive electronics 314 are integrated into the structure of the PEMF transducer 300. PEMF cord 316 connects PEMF transducer 300 with control unit 106.

The coils 318 of the PEMF transducer 300 are wound generally flat. Referring to Figure 12, the PEMF transducer 300 has an roughly flat cross section due to the flat winding of the coils 318. The windings 318 include primary coils 320, secondary coils 322 and sense coils 324. The transducer 300 includes two primary coils 320 with about 7 turns each, a secondary coil 322 with about 35 turns and a sense coil 324 with at least one turn. The primary coil 320 and secondary coil 322 can be wound with commercially available 18 gauge magnet wire, and the sense coil 324 can be wound with 22 gauge magnet wire. The winding bundle is roughly 0.75 by 0.12 inches. The wire is commercially available with an adhesive overcoat such as polyurethane adhesive. After winding, the winding bundle is heated in an oven to cure the adhesive.

The secondary windings 322 provide energy recovery and assist in the adjustment of the field output from the transducer 300. The secondary windings 322 are likely not necessary, and their functions can be replaced by more efficient electronics. Drive electronics 314 are carried by a circuit board embedded in the shell 326. The drive electronics 314 are connected to the primary 320, secondary 322 and sense 324 coils and the control unit 106 through PEMF cord 316.

The windings 318 are covered with a semi-rigid shell 326. The semi-rigid shell 326 maintains the contour of the PEMF transducer 300, but the shell 326 may be bendable to customize the contour for the individual patient. The shell 326 is produced from a plasticized elastomer such as polyurethane with a selected degree of rigidity. The shell can contain a polyurethane comprised of isocyanate and a polyol . The shell has approximate cross sectional dimensions of 1.50 by 0.31 inches. The cured winding bundle is placed in a mold to produce the shell. The drive electronics 314 are positioned in the mold and are electrically connected to the windings 318 and to the cord 316 before the elastomer is added to the mold. After the addition of the elastomer, the mold is placed in an oven for curing.

The drive electronics 314 control the production of the PEMF fields within the transducer 300. Figure 13 schematically depicts the electrical features of transducer 300. The drive electronics 314 include an FET switch 328 connected to one side of the primary coils 320. The FET switch has its control gate coupled to the control electronics. The FET switch 328 controls the powering and unpowering of the transducer 300. The other side of primary coils 320 are connected to a power supply in control unit 106. When the FET switch is turned off, current flows through the secondary windings 322 as the transducer 300 is denergized. Four energy recovery capacitors 330 store energy during transducer de-powering and release energy during transducer powering. Along with diode 332, capacitors 330 operate with the secondary winding 322 to store energy and thereby to conserve energy.

The sense windings 324 are coupled to the control unit 106. The sense windings 324 permit the detection of the electromagnetic fields generated by the transducer 300 enabling the control unit 106 to monitor the operation of the PEMF transducer 300. The energy supply for the transducer can be conveniently supplied by a battery (not shown) that is located either in the transducer unit 300 or the control unit 106. Other designs for the PEMF transducer are equally applicable to the present invention. Figure 14 displays a H-frame conduction transducer 350 similar to that shown in U.S. Patent 5,304,210 used to stimulate bone growth. H-frame conduction transducer 350 includes a brace 352 containing cavities 354, 356. Cavities 354, 356 contain electronics 358 for performing bone stimulation, healing monitoring, pain control, and other functions. A battery 360 can also be contained in cavities 354, 356. Cavities 354, 356 are covered by plates 362, 364 which are secured by fasteners 366 or are welded in place. Covers 362, 364 can have an opening 368 to permit the passage of wires 370 for connection of the H-frame conduction transducer 350 to control unit 106. Openings 372 provide for the attachment of fasteners, such as bolts, screws, etc., for anchoring the H-frame transducer 350 to the injured bone site. Alternatively, the H-frame conduction transducer 350 can be secured to restraining portions 112, 114 of frame 110 to obviate the need for surgery to hold the H-frame conduction transducer in its proper position. Figure 15 discloses an implantable AC conduction transducer 400 as described in European Patent Application 561,068 for stimulating bone growth. Figure 16 displays the implantable AC conduction transducer 400 prior to final assembly. The AC conduction transducer 400 includes a thin elongated arm 402 made of an elastic polymer. Elongated arm 402 connects a first electrode 404 and a second electrode 406. Elongated arm 402 positions the electrodes 404, 406 while allowing the conformation of the AC conduction transducer to the patient's body when it is surgically implanted. Elongated arm 402 is preferably made from Dow-Corning silicon based polymer MDX 4-4516, although other materials including urethane and silicon-urethane polymers can also be used. Electrodes 404, 406 can be made from titanium. Electrode 404 is exposed through a surface of electronics housing 408. Electronics housing 408 is coated with a non-conductive material such as parylene so no conductive material other than electrode 404 is exposed. Tube 410 provides a passage for electrical lead 412 which connects electrode 406 with the interior of electronics housing 408. Electrical lead 412 can be a helical coil of a medical grade metal such as MP35N. Electronics housing 408 has two lips 414 with rough surfaces to facilitate the attachment of electronics housing 408 with elongated arm 402. AC conducting transducer 400 is about 6 inches long and 0.2 inches thick.

AC conducting transducer 400 produces an alternating current between electrodes 404, 406. The alternating current produces an electric field that can be used to stimulate tissue healing or activity. The spacing of the electrodes and the AC nature of the current allows for the implantation of the AC conducting transducer 400 subcutaneously some distance away from the bone. The electrodes are implanted facing outward to minimize unwanted muscle stimulation.

Figure 17 schematically depicts the components within electronics housing 408. The components form an integrated circuit 416 with 28 external connections, pads 1 through 28. Integrated circuit 416 includes a crystal oscillator circuit 418, a power on reset circuit 420, a main time base circuit 422, an output driver circuit 424, a transmitter circuit 426, a PPM decoder circuit 428, a communication modem circuit 430, a lead status circuit 432, a receiver circuit 434, a battery status circuit 436 and a voltage reference/regulator circuit 438.

Crystal oscillator circuit 418 generates a clock signal, for example a typical frequency would be 76.8 kHz. Power on reset circuit 420 generates three reset outputs to set all other circuits in an initial state after power up. Main time base circuit 422 generates the pulse time signals for controlling the output driver circuit 424 which controls the output signal delivered to the patient. Transmitter circuit 426 combines pulse timing parameters from the PPM decoder 428 with the data output from the communications modem 430 to transmit a low frequency electromagnetic signal to an external receiver within control unit 106. PPM decoder circuit 428 produces the pulse position protocol for the transmitter circuit 426, and PPM decoder circuit 428 determines if information from receiver circuit 434 is a valid down-linked communication.

Communications modem circuit 430 receives signals from battery status circuit 436 and lead status circuit 432 to generate an 11-bit communications word for transmission to transmission circuit 426. Communications modem circuit 430 also controls the mode of operation of the integrated circuit 416 out of four possible modes through two output bits. Lead status circuit 432 compares the impedance of the output leads with threshold values. Receiver circuit 434 produces a digital signal based on an analog signal received from an external transmitter within control unit 106. Battery status circuit 436 monitors the voltage supplied to the circuit by an associated battery and signals the communications modem circuit 430 when the battery voltage reaches certain trip points. Voltage reference/regulator circuit 438 generates the bias currents used by integrated circuit 416.

Referring to Figures 18 and 19, muscle stimulation electrodes 450, 452 are depicted. The top portions 454 of electrodes 450, 452 are made from insulating polymeric material. Electrodes 450, 452 have leads 456 to provide electrical connection to control unit 106. The bottom surface of electrodes 450, 452 have a conducting portion 458 made from a conducting metal, graphite or similar material. Control unit 106 controls the flow of current to muscle stimulation electrodes 450, 452. Other bone and muscle stimulating conduction treatment transducers can be used in the invention besides those described above. Above, several energy transducer based treatment devices appropriate for use in the present invention have been discussed. Other energy transducers would also be appropriate for use in this invention, for example, a heating unit (not shown) for supplying heat to a treatment area and an inflatable bladder (not shown) that can be used to supply pressure to the treatment area. Furthermore, the present invention is not limited to the use of the specific embodiments or number of the energy transducers described above. Figure 2 depicts portable control unit 106 attached to support structure 108. The control unit 106 can take other forms such as a unit worn around the patient's waist 480, for example, as shown in Figure 20, or a portable table top model 482, for example, as shown in Figure 21. Furthermore, the control unit 106 can be placed within multiple housings.

Figure 22 displays a block diagram schematically representing control unit 106. The various components of control unit 106 are illustrated as being suitably electrically connected. The basic functions of the control unit 106 are to control the various treatment devices, monitor the functioning of the treatment devices, analyze the feedback from the treatment devices, vary the treatments based on the analysis, communicate the results to an optional monitoring station (not shown) , if applicable, and modify the treatment program based on input from the monitoring station, if applicable.

The control unit 106 includes a microprocessor 500. It will be appreciated that additional similar or different microprocessors may be utilized in the present invention. A variety of microprocessors are suitable including those from many manufacturers. The microprocessor is also illustrated as including nonvolatile data memory 502 and nonvolatile program memory 504. Non-volatile data memory 502 can be low power CMOS memory which can be read or written into. Non-volatile program memory 504 might be electronically programmable read only memory (EPROM) . Control unit 106 is further illustrated with a real time clock 506 including an alarm function. Control unit 106 includes a power supply 508 and an appropriate battery 510, such as a nickel cadmium battery. While Figure 20 shows a single power supply 508, the various power demands within control unit 106 might necessitate more than one power supply. Also, the control unit 106 can have a cord (not shown) for connecting to a standard power outlet to replace or supplement battery 510. Power supply 508 and battery 510 might also supply power to several of the treatment devices through connections to control unit 106. In alternative embodiments, a speaker and voice synthesizer (not shown) might be used to provide voice commands and information to the user, for example using the PCMCIA technology or similar means. In Figure 22, control unit 106 is displayed with a keypad 512 for user input into control unit 106. It will be appreciated that various types of user input devices might be utilized, e.g., a keypad having individual keys, a touch sensitive pad or others. The control unit 106 is illustrated with a graphic liquid crystal display 514 with various possible resolutions for displaying graphics and text information and suitable user alerts. Numerous display types can be successfully utilized in the present invention. A piezo alarm 516 can be used to supply audible alerts to the patient. Similarly, a common electromechanical vibrator 518 can be used to supply a palpable alarm. Control unit 106 is illustrated with an EIA 232C asynchronous communications port 520 to enable communications with remote devices. Of course, multiple communications ports might be present, and multiple communications protocols might be used. The communications port capability can have many uses, e.g., printout of selected information on a printer/plotter, downloading of memory onto an external storage device with removable media to allow transportation to a remote location, or other uses. The port can also be used for connection to a modem to enable communication with a remote computer or for direct connection to a nearby computer. Wireless transmission to a remote monitoring station can also be accomplished either through the use of the communications port 520 for connecting to an external receiver/transmitter or, alternatively, control unit 106 can have an internal transmitter 522 and a receiver 524 for communications to a monitoring station.

The internal transmitter 522 and receiver 524 can use various communications protocols depending on the demands of the transmission, such as the distance and location of the monitoring station. Examples of such protocols are disclosed in but not limited to protocols found in co-pending and commonly owned U.S. Patent applications serial nos. 08/298,591 filed August 31, 1994; 08/388,879 filed February 15, 1995; and 08/389,680 filed February 15, 1995, all of which are incorporated herein by reference.

Many of the components of control unit 106 are designed for interaction with the various treatment devices. Strain gauge 122 on restraining portions 112, 114 are connected to an amplifier 526. The output from amplifier 526 pass through a low pass filter 528 for filtering out background noise and other unwanted signal interference. The signal frequency from low pass filter 528 is roughly 400 Hz. The output from low pass filter 528 is transferred to sample/hold circuitry 530 which periodically samples the output from the low pass filter 528 and outputs the sampled electrical signal value to the analog to digital converter 532.

The control unit 106 receives an analog signal from position sensor (potentiometer-like mechanism) 174 which is configured to sense the relative angular position of first and second distal end portions 118, 120 of restraining portions 112, 114. The position sensor 174 is suitably electrically connected to analog to digital converter 532 which converts analog signals to digital signals. Voltage regulator 534 is appropriately connected to the electromechanical brake mechanism 176 or similar device to control the resistance to rotation of hinge 116.

In one embodiment, ultrasonic transducer 200 communicates with control unit 106 by way of fiber optic lines 206, 208. Note that the fiber optics lines 206, 208 can be replaced with electrical connections (not shown) where corresponding changes are made to the components of the control unit 106. Within control unit 106, a pulse generator 536, in conjunction with a pulse-width controlling device 538, e.g., a one-shot multivibrator, produces control pulses of a specified width and repetition rate. These control pulses regulate the on/off operation of ultrasonic transducer 200. Production of the control pulses can only proceed as long as an AND device 540 certifies that it is receiving a signal from treatment timer 542 indicating that the treatment time initiated by microprocessor 500 has not yet timed out. Pulsed output of AND device 540 is delivered to opto-driver 542, which may be a light emitting diode coupled for transmission of corresponding light pulses in fiber-optic line 206 to ultrasonic transducer 200. If signal monitoring means 262 in ultrasonic transducer 200 detects low battery output, signal changes, insufficient coupling of the transducer 242 with the patient or other problems, this is communicated by way of optical fiber 208 to opto receiver 544 in control unit 106. The shut-down signal received by opto receiver 544 is communicated to non-compliance/disable means 546. An alarm circuit 548 communicates to the microprocessor 500 in response to the receipt of the shut-down signal. An elapsed time indicator 550, in communication with microprocessor 500, is connected separately to the output line of the control pulse transmission and to the non-compliance/disable means 546. The elapsed time indicator 550 keeps track of total treatment time reflecting the increment of treatment time only as long as signal pulses monitored by signal monitoring means 262 compare favorably with intended signal transmission to the patient.

PEMF transducer is connected to control unit 106 by way of PEMF cord 316. The microprocessor 500 and interval timer/pulse counter 552 control a transducer drive amplifier 554. The transducer drive amplifier 554 controls the powering and unpowering of PEMF transducer 300. A field sense amplifier 556 is used to measure the resulting electromagnetic field and provide a corresponding signal to the microprocessor 500.

Wire 370 connects H-frame conduction transducer 350 with microprocessor 500. It should be noted that some or all of the electronic components can be moved from the H-frame conduction transducer 350 to the control unit 106 if desired.

Implantable conduction transducer 400 communicates with control unit 106 by way of transducer transmitter 558 and transducer receiver 560. PPM decoder 562 determines if valid information was received by transducer receiver 560 and generates the pulse position protocol used by transducer transmitter 558. Communications modem 564 mediates the communication between microprocessor 500 and implantable conduction transducer 400.

Voltage regulator 566 is controlled by microprocessor 500. Voltage regulator 566 directly controls the supply of power to muscle stimulating electrodes 450 and 452. The above description of control unit 106 is representative of one possible embodiment, and it is specific for the particular set of transducers described above. Appropriate modification would clearly follow from the use of different types of transducers or with the use of different designs of the same types of transducers. Appropriate modifications can be made by one of ordinary skill in the art based on the description provided. Also, even with the same set of transducers, a variety of configurations of control unit 106 are possible within this invention.

In one manner of placing the treatment device of the present invention on a patient, thin energy transducers are first applied to the patient's skin after the injured site has been suitably prepared. Next, a fabric stocking is preferably placed over the injured site and over the previously applied thin transducers. The fabric stocking protects and stabilizes the tissue in the vicinity of the injured site. The fabric stocking can be made from various natural and/or synthetic materials. The stocking could have an opening near the joint of the patient nearest the injured site. Any wires from the thin transducers can be passed through this opening for attachment to the control unit 106. The fabric stocking can be cut to form a hole to provide access to the skin for other thicker transducers. Next, a rigid support structure is preferably placed around the joint of the patient both to provide a support for the injured area and for the various treatment devices. The rigid support can be frame 110 as shown in Figure 2 or some other suitable support which surrounds the patient's injured area. A control unit 106, within one of the various possible forms noted above, is supplied and connected to the various treatment devices. The remaining energy transducers are put in place with support provided by the rigid support structure, if appropriate.

The physician's role is critical in the functioning of the present invention. Referring to Figure 23, the physician begins by performing 600 any required direct treatment of the injured site, for example, surgery or setting of broken bones. When any direct treatment is completed, the physician evaluates 602 the patient based on the extent of the injury, expected natural healing ability and tolerances to possible treatments. Next, the physician develops 604 a treatment strategy using the available treatment devices. The strategy preferably extends throughout the entire time of the healing process. Using this treatment strategy, the physician designs 606 the optimum placement and mix of specific transducers and support structures which make up the entire treatment device within the present invention.

Given the designed treatment device and the treatment strategy, the control unit 106 is programmed 608. The physician places 610 the treatment device on the patient and activates 612 the control unit. The progress of treatment is monitored periodically from the input received by a monitoring station or from data directly downloaded from the control unit 106. The physician will examine the monitored data to evaluate 616 the adequacy and appropriateness of the treatment. If necessary, the physician will modify 618 the treatment strategy by reprogramming 620 the control unit 106. The control unit 106 is reprogrammed by way of the monitoring station or by direct input into the control unit 106. The activation sequence 612 is repeated after reprogramming. The monitoring 614 and following steps are repeated until it is determined 622 the treatment is completed.

The unique features of the above orthopedic treatment process is that the physician develops a treatment strategy based on a variety of orthopedic treatment methods that can all be simultaneously and conveniently monitored and controlled. Therefore, the optimal treatment can be designed for a particular patient and modified as appropriate as treatment progresses . This allows the physician to efficiently and effectively provide improved care to an orthopedic injury patient. The methods and devices of the invention integrate the control of each of the selected treatments to optimize treatment results while minimizing intra and inter device interference.

Although the invention has been described and illustrated with a certain degree of particularity, it is understood that the present disclosure of embodiments has been made by way of example only and that numerous changes in the arrangement and combination of parts as well as steps may be resorted to by those skilled in the art without departing from the spirit and scope of the invention as claimed.

Claims

What is claimed is:
1. An orthopedic device comprising:
(a) two functionally distinct orthopedic treatment means, where said two functionally distinct orthopedic treatment means are selected from the group consisting of one exercise treatment means with one energy propagating transducer based treatment structure, two functionally distinct energy propagating transducer based orthopedic treatment structures and one monitored resistive non-isometric exercise means with one monitored isometric exercise means; and
(b) a portable, programmable control unit operably connected to each of said two functionally distinct orthopedic treatment means, wherein said control unit controls and monitors operation of said two functionally distinct treatment means.
2. The orthopedic device of claim 1, wherein said exercise treatment means include monitored isometric exercise means and monitored non-isometric exercise means, said orthopedic device further comprising a support structure wherein said support structure restrains flexibly connected body portions of an individual.
3. The orthopedic device of claim 3, wherein said monitored non-isometric exercise means include monitored resistive exercise means and monitored non-resistive exercise means.
4. The orthopedic device of claim 2, wherein said monitored isometric exercise means comprises at least one stress sensor for sensing stress on said support structure and for providing an electronic signal representative of said stress to said control unit, and where said support structure can selectively prevent relative motion of one of said flexibly connected body portions of an individual with respect to a second of said flexibly connected body portions of an individual.
5. The orthopedic device of claim 4, wherein a first of said functionally distinct treatment structures is said isometric exercise means and a second of said functionally distinct treatment structures is selected from said energy propagating transducer based treatment structures.
6. The orthopedic device of claim 3, wherein said monitored resistive exercise means comprises:
(a) a hinge for defining a selectable angular position of one portion of said support structure relative to a second portion of said support structure, wherein said first portion of said support structure restrains one of said flexibly connected body portions of an individual and said second portion of said support structure restrains a second of said flexibly connected body portions so that said selectable angular position defined by said hinge corresponds to an angle formed by said first and second flexibly connected body portions of an individual;
(b) resistance means providing selected resistance within said hinge against an angular motion of said hinge from one angular position to a second angular position; and
(c) a transducer operably connected to said control unit, said transducer providing an electronic signal representative of said angular position of said hinge.
7. The orthopedic device of claim 6, further comprising a range means selectively controlling an obtainable range of angular positions defined by said hinge.
8. The orthopedic device of claim 7, wherein said range means is operably connected to said control unit such that said control unit determines said permissible range of angular positions.
9. The orthopedic device of claim 6, wherein said resistance means is operably connected to said control unit such that an electrical signal from said control unit determines said selected resistance.
10. The orthopedic device of claim 6, wherein a first of said functionally distinct treatment means is said monitored resistive exercise means and a second of said functionally distinct treatment means is selected from said energy propagating transducer based treatment structures.
11. The orthopedic device of claim 6, wherein a first of said functionally distinct treatment means is said monitored resistive exercise means and a second of said functionally distinct treatment structures is an isometric exercise means comprising at least one stress sensor for sensing stress on said support structure and for providing an electronic signal representative of said stress to said control unit; where said support structure, in cooperation with said hinge, can selectively prevent relative motion of one of said flexibly connected body portions of an individual with respect to a second of said flexibly connected body portions of an individual .
12. The orthopedic device of claim 2, further comprising a support structure configured so that said energy propagating transducer based orthopedic treatment structures can be positioned on said support structure to direct energy toward an injured portion of an individual.
13. The orthopedic device of claim 1, in which said energy propagating transducer based treatment structures are selected from a list including ultrasonic treatment structures, pulsed electromagnetic field treatment structures, electrical conduction treatment structures, heating structures and inflatable bladders.
14. The orthopedic device of claim 13, wherein said ultrasonic treatment structure comprises: (a) a treatment head operably connected to said control unit, said treatment head including an ultrasonic transducer; and (b) attachment means for binding said treatment head and of securing said head proximate to a selected body portion of an individual.
15. The orthopedic device of claim 13, wherein said pulsed electromagnetic field structure comprises:
(a) coils constructed of a conducting material; and
(b) an insulating housing covering said coils, said insulating housing comprised of an elastomeric material; wherein the flow of electrical current to said coils is controlled by said control unit.
16. The orthopedic device of claim 13, wherein said electrical conduction treatment structures can be selected from the group consisting of muscle stimulation treatment structures and electric field bone growth stimulation treatment structures.
17. The orthopedic device of claim 13, wherein said electrical conduction treatment structures can be implantable.
18. An orthopedic treatment device comprising:
(a) a support structure for restraining flexibly connected body portions of an individual; (b) a hinge for defining a selectable angular position of one portion of said support structure relative to a second portion of said support structure, wherein said first portion of said support structure restrains one of said flexibly connected body portions of an individual and said second portion of said support structure restrains a second of said flexibly connected body portions so that said selectable angular position defined by said hinge corresponds to an angle formed by said first and second flexibly connected body portions of an individual; (c) a portable, programmable control unit; and
(d) resistance means providing selected resistance within said hinge against angular motion of said hinge from one angular position to a second angular position; said resistance means being operably connected to said control unit so that an electrical signal from said control unit determines the selected resistance.
19. The orthopedic treatment device of claim 18, further comprising a transducer operably connected to said control unit, said transducer providing an electronic signal representative of said angular position of said hinge.
20. The orthopedic device of claim 18, further comprising a stress sensor for sensing stress on said support structure and for providing an electrical signal representative of said stress to said control unit.
21. The orthopedic device of claim 18, further comprising a range means selectively controlling an obtainable range of angular positions defined by said hinge.
22. The orthopedic device of claim 21, wherein said range means is operably connected to said control unit such that said control unit determines said obtainable range of angular positions permitted by said range means.
23. A method of treating an orthopedic injury comprising the steps of: (a) connecting an orthopedic treatment device to an individual user in the vicinity of a musculo-skeletal injury; and
(b) configuring the orthopedic treatment device to utilize at least two functionally distinct treatment protocol means controlled by a portable, programmable control unit operably connected to each of said two functionally distinct treatment protocol means; where said two functionally distinct orthopedic treatment protocol means are selected from the group consisting of one exercise treatment means with one energy propagating transducer based treatment structure, two functionally distinct energy propagating transducer based orthopedic treatment structures and a monitored resistive non-isometric exercise means with a monitored isometric exercise means.
24. The method of claim 23, further comprising the step of the individual user following any treatment instructions provided by said control unit.
25. A method of treating an orthopedic injury comprising the steps of:
(a) evaluating the condition of a patient;
(b) developing a treatment strategy including two or more distinct treatment methods, wherein said treatment methods can be controlled and monitored by a control unit;
(c) configuring an orthopedic treatment device to implement said treatment strategy;
(d) programming said control unit based on said treatment strategy; (e) connecting said orthopedic treatment device to said patient; and
(f) activating said control unit; where said two distinct orthopedic treatment methods are selected from the group consisting of one exercise treatment methods with one energy propagating transducer based treatment method, two functionally distinct energy propagating transducer based orthopedic treatment method and a monitored resistive non-isometric exercise method with a monitored isometric exercise method.
26. The method of claim 25, further comprising the steps of:
(a) monitoring the progress of said treatment based on said treatment strategy;
(b) evaluating said treatment strategy based on said monitored results; and (c) modifying said treatment strategy, if appropriate.
27. The method of claim 26 further comprising periodic repetition of steps (a) - (c) of claim 26 until treatment is completed.
28. The method of claim 27, wherein said exercise treatment methods include monitored isometric exercise methods and monitored non-isometric exercise methods, said orthopedic treatment device further comprising a support structure wherein said support structure restrains flexibly connected body portions of an individual.
29. The method of claim 28, wherein said orthopedic treatment device further comprises at least one stress sensor for sensing stress on said support structure and for providing an electronic signal representative of said stress to said control unit, and where said support structure can selectively prevent relative motion of one of said flexibly connected body portions of an individual with respect to a second of said flexibly connected body portions of an individual.
30. The method of claim 28, wherein said orthopedic treatment device further comprises:
(a) a hinge for defining a selectable angular position of one portion of said support structure relative to a second portion of said support structure, wherein said first portion of said support structure restrains one of said flexibly connected body portions of an individual and said second portion of said support structure restrains a second of said flexibly connected body portions so that said selectable angular position defined by said hinge corresponds to an angle formed by said first and second flexibly connected body portions of an individual;
(b) resistance means providing selected resistance within said hinge against angular motion of said hinge from one angular position to a second angular position; and (c) a transducer operably connected to said control unit, said transducer providing an electronic signal representative of said angular position of said hinge.
31. The method of claim 25, wherein said energy transducer propagating treatment methods are based on structures that include ultrasonic treatment structures, pulsed electromagnetic field treatment structures, electrical conduction treatment structures, heating units and inflatable bladders.
32. The method of claim 25, wherein said control unit adjusts functioning of treatment structures implementing said treatment methods, where said adjustments are based on monitored results and are devised to approach maximized healing within the user's physical capabilities.
PCT/US1996/007047 1995-05-17 1996-05-16 An orthopedic device supporting two or more treatment systems and associated methods WO1996036278A1 (en)

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US08/442,945 1995-05-17

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EP96920238A EP0957762A4 (en) 1995-05-17 1996-05-16 An orthopedic device supporting two or more treatment systems and associated methods
JP8535054A JPH11505161A (en) 1995-05-17 1996-05-16 Surgical apparatus and method for supporting two or more therapeutic system

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EP0957762A1 (en) 1999-11-24
EP0957762A4 (en) 2003-04-02
JPH11505161A (en) 1999-05-18

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