US20070213179A1

Movatterモバイル変換

Info

Publication number: US20070213179A1
Application number: US11/716,213
Authority: US
Inventors: Titi Trandafir
Original assignee: Juvent Inc
Current assignee: American Medical Innovations LLC
Priority date: 2006-03-09
Filing date: 2007-03-08
Publication date: 2007-09-13
Also published as: WO2007103414A2; WO2007103414A3

Abstract

A mechanical loading apparatus having an oscillating platform and a signal modulating assembly for modulating an operating signal of the oscillating platform for therapeutically treating damaged tissues, bone fractures, osteopenia, osteoporosis, or other tissue condition, as well as postural instability. The signal modulating assembly modulates the operating signal such that the oscillating platform oscillates at frequency which simulates human activities, such as, walking, jogging, running, stair climbing, etc. The mechanical loading apparatus further includes a control panel having control knobs or buttons for manually selecting a desired activity to be simulated by the mechanical loading apparatus.

Description

PRIORITY

This patent application claims priority to a provisional application filed on Mar. 9, 2006 and assigned U.S. Provisional Application Ser. No. 60/780,656; the entire contents of which are incorporated herein by reference.

CROSS-REFERENCE TO RELATED PATENTS

The present application is related to U.S. Pat. Nos. 6,843,776 and 6,884,227, the contents of which are incorporated herein by reference.

BACKGROUND

1. Technical Field

The present disclosure relates generally to a medical treatment apparatus for stimulating tissue growth and healing. In particular, the present disclosure relates to a mechanical loading apparatus having a signal modulating assembly for therapeutically treating damaged tissues, bone fractures, osteopenia, osteoporosis or other tissue conditions, as well as postural instability.

2. Background of the Related Art

When damaged, tissue in a human body such as connective tissue, ligaments, bones, etc. all require time to heal. Some tissues, such as bone fracture in a human body, require relatively longer periods of time to heal. Typically, a fractured bone must be set and then the bone can be stabilized within a cast, splint or similar type of device. This type of treatment allows the natural healing process to begin. However, the healing process for a bone fracture in the human body may take several weeks and may vary depending upon the location of the bone fracture, the age of the patient, the overall general health of the patient, and other factors that are patient-dependent. Depending upon the location of the fracture, the area of the bone fracture or even the patient may have to be immobilized to encourage complete healing of the bone fracture. Immobilization of the patient and/or bone fracture may decrease the number of physical activities the patient is able to perform, which may have other adverse health consequences. Osteopenia, which is a loss of bone weight, can arise from a decrease in muscle activity, which may occur as the result of a bone fracture, bed rest, fracture immobilization, joint reconstruction, arthritis, and the like. However, this effect can be slowed, stopped, and even reversed by reproducing some of the effects of muscle use on the bone. This typically involves some application or simulation of the effects of mechanical stress on the bone.

Promoting bone growth is also important in treating bone fractures, and in the successful implantation of medical prostheses, such as those commonly known as “artificial” hips, knees, vertebral discs, and the like, where it is desired to promote bony ingrowth into the surface of the prosthesis to stabilize and secure it. Numerous different techniques have been developed to reduce the loss of bone weight. For example, it has been proposed to treat bone fractures by application of electrical voltage or current signals (e.g., U.S. Pat. Nos. 4,105,017; 4,266,533; or 4,315,503). It has also been proposed to apply magnetic fields to stimulate healing of bone fractures (e.g., U.S. Pat. No. 3,890,953). Application of ultrasound to promoting tissue growth has also been disclosed (e.g., U.S. Pat. No. 4,890,953).

It is also known in the art that low level, high frequency stresses can be applied to the bone growth. One technique for achieving this type of stress is disclosed in commonly owned U.S. Pat. No. 6,843,776, the entire contents of which are incorporated herein by reference. A method for therapeutically treating damaged tissue in a body having a weight is described in U.S. Pat. No. 6,843,776 includes the steps of (a) supporting the body on a platform; (b) oscillating the platform at a predetermined frequency to impart an oscillating force on the body; and (c) automatically determining the weight of the body, via a capacitor assembly operatively connected to the platform.

The method described in U.S. Pat. No. 6,843,776 entails the treatment of damaged tissues, bone fractures, osteopenia, osteoporosis, and other conditions. The patient stands on an oscillating platform apparatus configured to impart oscillating force on the body. A capacitor assembly is positioned adjacent the platform for automatically determining the weight of the body being supported on the platform. Once the weight of the body is determined, the amplitude of a frequency of the oscillating force is adjusted to provide a desired therapeutic treatment to the patient. The apparatus and method described in U.S. Pat. No. 6,843,776 provides an oscillating platform wherein the patient is subjected to a constant oscillating force. The peak-to-peak vertical displacement of the platform oscillating may be less than 2 mm.

SUMMARY

The present disclosure provides a mechanical loading apparatus having an oscillating platform and a signal modulating assembly for modulating an operating signal of the oscillating platform for therapeutically treating damaged tissues, bone fractures, osteopenia, osteoporosis, or other tissue condition, as well as postural instability. The signal modulating assembly in accordance with the present disclosure effectively modulates the operating signal such that the oscillating platform oscillates or vibrates at a frequency which simulates a human activity, such as, walking, jogging, running, stair climbing, etc.

In a preferred embodiment, the mechanical loading apparatus further includes a control panel having control knobs or buttons for enabling a user to select a desired activity to be simulated by the mechanical loading apparatus. A processor assembly is included for receiving a signal from the control panel. The processor assembly is adapted for sending instructions to the signal modulating assembly for modulating the operating signal in accordance with the signal received from the control panel. The signal modulating assembly then modulates the operating signal of the oscillator in accordance with the instructions received from the processor assembly. The operating signal may include a variety of waveforms, such as, for example, a sinusoidal wave, half-sinusoidal wave, triangular wave, square wave, saw-tooth wave or trapezoidal wave, and the like. A method of therapeutically treating damaged tissue of a body by modulating the operating signal is also envisioned.

Other features and advantages of the present disclosure will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, which illustrate, by way of example, the principles of the disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing features of the present disclosure will become more readily apparent and will be better understood by referring to the following detailed description of preferred embodiments, which are described hereinbelow with reference to the drawings wherein:

FIG. 1 is a side cross-sectional view of an oscillating platform of the mechanical loading apparatus having a signal modulating assembly in accordance with the present disclosure;

FIG. 2 is a flow diagram illustrating various circuitry blocks of the mechanical loading apparatus shown byFIG. 1;

FIG. 2A illustrates a control panel of the mechanical loading apparatus in accordance with the present disclosure;

FIG. 3A illustrates a signal waveform generated by the signal modulating assembly in accordance with the present disclosure;

FIG. 3B illustrates two signal waveforms generated by the signal modulating assembly in accordance with the present disclosure;

FIG. 4 is a perspective view illustrating an oscillating platform of a mechanical loading apparatus having a signal modulating assembly in accordance with the present disclosure being mounted to an ergonomic hand support structure; and

FIG. 5 is a perspective view illustrating another embodiment of the ergonomic support structure having an ergonomic hand support structure, a monitor provided on a column and a platform for supporting the oscillating platform having a signal modulating assembly in accordance with the present disclosure.

DETAILED DESCRIPTION

With reference toFIG. 1, there is shown a mechanical loading apparatus for therapeutically treating damaged tissues, bone fractures, osteopenia, osteoporosis or other tissue conditions, as well as postural instability. The mechanical loading apparatus can also be used for stimulating cartilage growth and for bony ingrowth.

The mechanical loading apparatus includes an oscillating platform and a signal modulating assembly adapted for modulating an operating signal of the oscillating platform. The operating signal is modulated substantially in real-time in order for the oscillating platform to oscillate or vibrate in real-time at a frequency which simulates a human activity, such as, for example, walking, jogging, running, stair climbing, etc.

Referring now in detail to the drawing figures, in which like references numerals identify similar or identical elements, a mechanical loading apparatus having a signal modulating assembly in accordance with the present disclosure is illustrated byFIG. 1 and is designated generally byreference numeral100.

Mechanical loading apparatus

100 includes anoscillating platform110 and asignal modulating assembly152. Theoscillating platform110 is highly stable and relatively insensitive to positioning of the patient on theplatform110, while providing low displacement, high frequency mechanical loading of a body tissue sufficient to promote healing and/or growth of tissue damage, bone tissue, or reduce, reverse, or prevent osteopenia, osteoporosis or other tissue condition, as well as treat postural instability.

Mechanical loading apparatus

100 is housed within ahousing102 and includesoscillating actuator104,capacitor assembly106, and signal modulatingassembly108. Thehousing102 includes upper plate or oscillatingplatform110,lower plate112 andside walls114.

Oscillatingactuator104 mounts tolower plate112 byoscillator mounting plate116 and connects to drivelever118 by one ormore connectors120. It is noted thatFIG. 1 is partially cut away to show details of the connection of oscillatingactuator104 to drivelever118. At rest, thedrive lever118 is supported in static equilibrium at a first end thereof by a damping member orspring122. Dampinglever118 is activated by oscillatingactuator104 which causes drivelever118 to pivot a fixed distance around drivelever pivot point124. Drivelever pivot point124 is mounted on a drivelever mounting block126. Oscillatingactuator104 may be, for example, a voice coil.

Oscillatingactuator104 actuates thedrive lever118 at a first predetermined frequency. Preferably, thedrive lever118 oscillates between 30 and 100 Hz or at a frequency to simulate a human activity as described hereinbelow. The frequency is typically within the range or 25-40 Hz and fixed or varied in accordance with the treatment desired, i.e., bone fracture healing, postural instability treatment, osteoporosis treatment, cartilage growth stimulation, bony ingrowth, etc

Oscillating platform

110 is preferably part of a harmonically excited system. Accordingly, the first predetermined frequency is equal to, or equivalent to, the resonant frequency, thus requiring minimum energy input. The resonant frequency is a function of the characteristics of the weight of the person andspring122.

The motion of thedrive lever118 around the drivelever pivot point124 is damped byspring122.Spring122 creates an oscillation force at a second predetermined frequency. One end ofspring122 is connected to spring mountingpost128, which is supported to mountingblock130, while the other end ofspring122 is connected to distributinglever support platform132. Distributinglever support platform132 is connected to drivelever118 by connectingplate134.

With continued reference toFIG. 1 and in accordance with the present disclosure,capacitor assembly106 includes a pair of capacitors136,138 and a common plate140 being positioned adjacent to a second end ofdrive lever118. Thecapacitor assembly106 is configured to generate and transmit an electronic signal which is representative of a distance between at least one of the capacitors136 and138, and common plate140 for determining the weight of a patient on theupper plate110, as described by U.S. Pat. No. 6,843,776, with reference toFIGS. 14A-C andFIGS. 15-16. Themechanical loading apparatus100 can also include two accelerometers for determining the weight of a patient as described in U.S. Provisional Application No. 60/665,013 filed on Mar. 24, 2005, the entire contents of which are incorporated herein by reference.

With reference toFIGS. 1-2 of the present disclosure,signal modulating assembly108 will now be discussed. The primary function ofsignal modulating assembly108 is to modulate the operating or drive signal of oscillatingactuator104 for oscillatingplatform110 at frequencies which simulate human activities, such as, for example, walking, jogging, running, stair climbing, etc. Signal modulatingassembly108 receives instructions fromprocessor assembly152 and, in turn, modulates the operating signal of oscillatingactuator104 according to the instructions received fromprocessor assembly152.

Signal modulatingassembly108 is preferably mounted tolower plate112 ofhousing102 by signal modulating mountingplate142. Signal modulatingassembly108 includescable assembly144 for operably connectingsignal modulating assembly108 to oscillatingactuator104; andcable assembly146 for connectingsignal modulating assembly108 toprocessor assembly152.Processor assembly152 is connected to acontrol panel150 either wirelessly or viacable assembly147.

With reference toFIG. 2A, in conjunction withFIGS. 1-2,control panel150 will now be discussed in detail.Control panel150 includes a plurality of control knobs or buttons for controllingsignal modulating assembly108 and permitting a user to select an activity to be simulated bymechanical loading apparatus100, such as, for example, walking, jogging, running, stair climbing, etc.Control panel150 may also be touch sensitive wherein the user is able to select an activity by touching the appropriate section corresponding to the activity desired.Control panel150 includes awindow display154 for displaying treatment information and other information to the user during vibrational treatment.Buttons156 permit the user to select a desired human activity to be simulated bymechanical loading apparatus100. The user may choose to simulate walking, jogging, running, or stair climbing by selecting anappropriate button156. Moreover, the user may select an activity and then usespeed button158 to increase or decrease the frequency and intensity of oscillation.

For example, if the user initially elects to simulate walking, the user may subsequently switch to jogging or running by pressing the up arrow ofdisplay158. Accordingly, a signal is transmitted toprocessor assembly152 which in turn sends instructions to modulatingassembly108 to increase the modulation (i.e., increase the frequency) of the operating signal of oscillatingactuator104 based on the received signal. The user may then return to a slower or a walking pace by pressing the down arrow ofdisplay158 to decrease the modulation (i.e., decrease the frequency) of the operating signal of oscillatingactuator104. It is envisioned that the patient may choose from a variety of activities. For example, a user may choose to simulate walking, jogging, running, stair climbing, etc.

Alternatively, the user, viacontrol panel150, can select a preprogrammed series of activities, such as, for example, by pressingprogram A button160 andprogram B button162, whereinprogram A button160 enablesmechanical loading apparatus100 to execute treatment program A which can include simulating walking, jogging, and then walking again. A more intense program is presented by pressingprogram B button162, wheremechanical loading apparatus100 executes treatment program B which can include simulating walking, jogging, running, and walking again. Moreover, a patient may customize the session by selectingcustom button164, which permits the user to customize a treatment program for simulating one or more human activities during a treatment duration. Preferably,control panel150 includes atimer button166 for displaying the elapsed time and adistance display button168 for displaying the distance the patient would have traveled if he was actually performing the simulated human activities. Avisual display panel170 indicates diagrammatically the distance the patient would have traveled.

Control panel

150 can further be designed for enabling a user to select a particular signal waveform for use in driving thesignal modulating assembly108 during at least a portion of the treatment duration. The signal waveform can be triangular, square, sinusoidal, half-sinusoidal, trapezoidal, saw-tooth, staircase, sweeping vibrational signal, continuous ramping (increasing diagonal signal), bursts with relaxation time as shown byFIG. 3A and without relaxation time (continuous bursts), and combinations thereof. The sweeping vibrational signal is a signal which sweeps from a first frequency to a second and final frequency. For example, the sweeping vibrational signal can sweep from 30 Hz to 120 Hz in 24 minutes at increments of 30 Hz every 8 minutes during a treatment time of 32 minutes (30 Hz for the first eight minutes; 60 Hz for the second eight minutes; 90 Hz for the third eight minutes; and 120 Hz for the last eight minutes). The signal waveforms can also be generated by themechanical loading apparatus100 automatically and without any user selection or intervention.

When a user selects an activity viacontrol panel150 or a particular signal waveform for modulating the operating signal of theoscillating actuator104, or themechanical loading apparatus100 automatically selects a signal for modulating the operating signal of theoscillating actuator104, a signal is sent toprocessor assembly152 which generates instructions which are transmitted via signals to signal modulatingassembly108. Whensignal modulating assembly108 receives the instructions fromprocessor assembly152,signal modulating assembly108 modulates the operating signal of theoscillating actuator104 for simulating the desired human activity, or for driving theoscillating actuator104 using the desired signal waveform as selected viacontrol panel150 or automatically selected by themechanical loading apparatus100. Numerous other features may be added to controlpanel150, such as, for example, an incline button for controlling an incline mechanism withinhousing102 to control incline and decline ofoscillating platform110 ofmechanical loading apparatus100.

With reference toFIG. 3B, two modulated operating signals of theoscillating actuator104 are illustrated.Sinusoidal wave302 is an operating signal for simulating walking.Sinusoidal wave304 is an operating signal for simulating running. Although sinusoidal waves are illustrated in the figure, other waveforms are envisioned, such as, for example, trapezoidal waves, sinusoidal waves, half-sinusoidal waves, triangular waves, square waves, saw-tooth waves, etc.

In operation, when a specific load is placed onupper plate110 ofhousing102 ofmechanical loading apparatus100, i.e. a patient,capacitor assembly106 automatically determines the weight of the body being supported onmechanical platform100, in a manner described in detail in U.S. Pat. No. 6,843,776. Once the weight of the body is determined, an amplitude of the frequency of the oscillating force is adjusted to provide a desired therapeutic treatment to the patient according to the patient's weight. The patient can then usecontrol panel150 to select one or more desired human activities to be simulated by the mechanical loading apparatus over the treatment duration, as described hereinabove. Whensignal modulating assembly108 receives the control signal fromprocessor assembly152,signal modulating assembly108 modulates the operating signal and transmits it to oscillatingactuator104 for changing the oscillation ofplatform110 to simulate a human activity, such as walking, jogging, running, stair climbing, etc.

With reference toFIG. 4-5,mechanical loading apparatus100 is preferably mounted to a supplemental support structure including an ergonomic hand support structure, as disclosed and described in U.S. Provisional Patent Application No. 60/659,159, filed on Mar. 7, 2005, the entire contents of which are incorporated herein by reference. With particular reference toFIG. 4, an ergonomic hand support structure is designated generally byreference numeral200. The ergonomichand support structure200 includes aframe202 having a mountingtray204 for placement of amechanical loading apparatus100 thereon. Preferably,mechanical loading apparatus100 is removable from mountingtray204. Mountingtray204 is pivotable with respect to avertical column206 offrame202 at one end of thevertical column206 configured for standingframe202 on a flat surface. Another end ofvertical column206 includes two parallel extension bars208 protruding vertically fromvertical column206.

The two parallel extension bars208 support amonitor210, twocup holders212 and ahand support structure214. The two parallel extension bars208 slide in and out ofvertical column206 for changing the height of theframe202 by pulling onadjustment knob209.

Monitor

210 receivescontrol panel150 displays treatment information and other information, including video, to a patient during vibrational treatment.Monitor210 is provided within a monitor support216. Preferably, monitor210 is inlaid within the monitor support216 for enabling a patient to place a book, laptop, etc. on the monitor support216 without contacting the monitor216.

Thehand support structure214 includes acurved holding bar218 and alateral holding bar220. It is desirable for the patient to grasp thelateral holding bar220 when climbing on and off themechanical loading apparatus100 and to grasp thecurved holding bar218 during vibrational treatment.

After themechanical loading apparatus100 is placed on the mountingtray204, a patient suffering from damaged tissues, bone fractures, osteopenia, osteoporosis, or other condition as well as postural instability can stand onmechanical loading apparatus100 and be treated by themechanical loading apparatus100. During treatment, thecurved holding bar218 enables the patient to grasp and maintain his balance while being treated by themechanical loading apparatus100.

With reference toFIG. 5, there is shown a perspective view of an ergonomic hand support structure designated generally byreference numeral500.Ergonomic support structure500 includes an ergonomichand support structure502 and aplatform504 for supporting a mechanical loading apparatus100asimilar tomechanical loading apparatus100 and having modulatingsignal assembly108. The mechanical loading apparatus100ais preferably removable from theplatform504.

The ergonomichand support structure502 includes acurved structure506 having inner and outer

curved walls

508a,508band two

curved ends

510a,510bconnecting the two

walls

508a,508b.During vibrational treatment by mechanical loading apparatus100a,the patient grasps the longcurved end510aor lightly touches the innercurved wall508a.

Theergonomic support structure500 further includes aseat512 for placement on two opposing surfaces (not shown) defined by the innercurved wall508a.Accordingly, during vibrational treatment by the mechanical loading apparatus100a,the patient can sit on theseat512.

Theergonomic support structure500 further includes anRFID reader514 for reading an RFID tag provided on the patient for identifying the patient. TheRFID reader514 further includes adisplay516 for displaying patient identification data and other data, including video. TheRFID reader514 also includes a processor (not shown) storing patient-related data, such as patient identification data, and treatment data, such as, for example, the dates and duration times of the last five vibrational treatment sessions. The patient-related data for each particular patient is accessed and portions thereof displayed by thedisplay516 after the patient's corresponding RFID tag is read by theRFID reader514.

Theergonomic support structure500 further includes avertical column518 having amonitor520 for displaying patient identification data and other data, such as patient treatment data, including video. Preferably, themonitor520 is inlaid withinvertical column518 for enabling the patient to place a book, laptop, etc. onvertical column518 without contactingmonitor520.Vertical column518 is preferably height adjustable to accommodate patients of differing heights. Anothermonitor522 is provided on theouter wall508b.Theouter wall508bis further provided with alight source524 above themonitor520 andcontrol buttons526.

It is contemplated to provide the support structures shown inFIGS. 4-5 with circuitry and related components for connecting to a network, such as the Internet, wirelessly and/or non-wirelessly and at least one processor for transmitting and receiving data via the network as known in the art. The data transmitted can include patient monitoring data to determine at a central monitoring station if the patient is complying with a treatment regiment and data to determine whether the patient is properly positioned on the mechanical loading apparatus100ato obtain optimum treatment effects. The data can include video and/or sensor data obtained by a video camera and/or at least one sensor mounted to the support structures and transmitted via the network to the central monitoring station. The data received can include Internet content and treatment-related data transmitted from the central monitoring station. The data received can include visual and/or audio content for viewing via the

monitor

210,520 and/or listening via earphones connected to audio circuitry embedded within the support structure.

It will be understood that various modifications and changes in form and detail may be made to the embodiments of the present disclosure without departing from the spirit and scope of the disclosure. Therefore, the above description should not be construed as limiting the disclosure but merely as exemplifications of preferred embodiments thereof.

Claims

1. An apparatus for therapeutically treating tissue in a body, the apparatus comprising:

a platform configured to support the body;

an oscillating actuator configured to receive an operating signal for oscillating the platform at a first frequency; and

a modulating assembly operably connected to the oscillating actuator for modulating the operating signal of the oscillating actuator to change the oscillation of the platform from the first frequency to a second frequency.

2. The apparatus according toclaim 1, further comprising a capacitor assembly positioned adjacent the platform for automatically determining the weight of the body being supported on the platform.

3. The apparatus according toclaim 1, further comprising a control panel operably connected to the modulating assembly for controlling the modulation of the operating signal.

4. The apparatus according toclaim 1, wherein oscillation of the platform at the first frequency simulates a first human activity and oscillation of the platform at the second frequency simulates a second human activity.

5. The apparatus according toclaim 4, wherein the first and second human activities are selected from the group consisting of walking, jogging, running and stair climbing.

6. The apparatus according toclaim 1, further comprising a processor assembly for controlling the modulating assembly.

7. The apparatus according toclaim 6, wherein the processor assembly stores at least one treatment program capable of simulating at least one human activity when executed by said processor assembly.

8. The apparatus according toclaim 3, wherein the control panel includes a custom button for customizing a treatment program for simulating at least one human activity during a treatment duration.

9. The apparatus according toclaim 3, wherein the control panel includes a control button for manually controlling the modulation assembly.

10. The apparatus according toclaim 1, wherein the operating signal is selected from the group consisting of triangular, square, sinusoidal, half-sinusoidal, trapezoidal, saw-tooth, staircase, continuous ramping, sweeping vibrational signal, bursts with relaxation time and without relaxation time, and combinations thereof.

11. The apparatus according toclaim 1, further comprising:

means for engaging the platform; and

support means operatively connected to the means for engaging for supporting the patient on the platform.

12. A method for therapeutically treating tissue in a body, the method comprising:

supporting the body on a platform;

oscillating the platform at a first frequency to simulate a first human activity; and

oscillating the platform at a second frequency to simulate a second human activity.

13. The method ofclaim 12, further comprising the step of determining the weight of the body supported on the platform.

14. The method ofclaim 12, wherein the first and second human activities are selected from the group consisting of walking, jogging, running and stair climbing.

15. The method ofclaim 12, further comprising the step of controlling the oscillation of the platform from a control panel.

16. The method ofclaim 12, further comprising the step of customizing a treatment program for simulating at least one human activity during a treatment duration.

17. The method ofclaim 12, further comprising the step of displaying the distance the patient would have traveled if actually performing the simulated first and second human activities.

18. The method ofclaim 12, further comprising transmitting treatment data from a platform site via a communications medium to a remote monitoring station.

19. The method ofclaim 12, further comprising the step of controlling a modulating assembly operably connected to an oscillating actuator for modulating an operating signal of the oscillating actuator for performing the oscillating steps.

20. The method ofclaim 12, wherein the duration of each oscillating step is determined according to a stored treatment program.

21. The method ofclaim 12, wherein the first and second frequencies are different for simulating human activities selected from the group consisting of walking, jogging, running and stair climbing.