1. Technical Field
The present disclosure relates to apparatuses and methods for combining limb shaping with vibrational treatment of bones. More particularly, the present disclosure relates to apparatuses and methods for combining limb shaping with vibrational treatment of bone tissue following a bone-related medical procedure.
The bone-related medical procedure can be performed due to a musculoskeletal-related injury, bone-related condition, such as osteoporosis, bone deformities, or other musculoskeletal related conditions. Some types of bone-related medical procedures include a procedure which entails providing a synthetic bone graft material or bone void filler to influence or facilitate bone ingrowth; a procedure which entails stabilizing a bone fracture by inserting pins through the skin and the bone; limb shaping procedures which entails using external fixators for limb lengthening (distraction osteogenesis) and/or limb straightening; a procedure which entails attaching a limb; a procedure which entails providing the patient with a cast, such as providing the patient with a cast surrounding a portion of a limb or an entire body cast; and joint fusion, a procedure which entails permanently fusing bones, such as in the case of an unnatural fracture of the ankle and spinal fusion procedures using spinal cages.
One type of bone-related medical procedure utilized during bone shaping treatments of particular interest in the present disclosure is the Ilizarov method, which permits bone lengthening at a rate of 1.0 to 1.5 mm per day.
2. Description of the Related Art
A method of using resonant vibrations for treating postural instability (thus affecting the musculoskeletal system of a patient) is described in U.S. Pat. No. 6,607,497. The method includes the steps of (a) providing a vibration table having a non-rigidly supported platform; (b) permitting the patient to rest on the non-rigidly supported platform for a predetermined period of time; and (c) repeating the steps (a) and (b) over a predetermined treatment duration. Step (b) includes the steps of (b1) measuring a vibrational response of the patient's musculoskeletal system using a vibration measurement device; (b2) performing a frequency decomposition of the vibrational response to quantify the vibrational response into specific vibrational spectra; and (b3) analyzing the vibrational spectra to evaluate at least postural stability.
The method described in U.S. Pat. No. 6,607,497 entails the patient standing on the vibration table or unstable standing platform which includes at least one accelerometer mounted to the outboard side thereof. The patient is then exposed to a vibrational stimulus by the unstable standing platform. The unstable standing platform causes a vibrational perturbation of the patient's neuro-sensory control system. The vibrational perturbation causes signals to be generated within at least one of the patient's muscles to create a measurable response from the musculoskeletal system. These steps are repeated over a predetermined treatment duration for approximately ten minutes a day in an effort to improve the postural stability of the patient.
In accordance with the present disclosure, apparatuses and methods are described for combining limb shaping with vibrational treatment of bones.
One technique used during limb shaping is limb-lengthening treatment, which entails using the Ilizarov method. The Ilizarov method is a bone lengthening technique, whereby a bone is lengthened at a rate of 1.0 to 1.5 mm per day. The gradual distraction allows the neurovascular bundle and muscles to lengthen safely. In addition, osteotomy is performed at lower metaphyseal levels for enhanced bone healing. The Ilizarov system is used in a surgical procedure that can be utilized to lengthen and/or shaping limb bones. The procedure is often used to treat complex and/or open bone fractures, where conventional treatment techniques cannot be used. The procedure involves breaking the bone to be adjusted. Metal rings are then attached to the bone sections by rods, wires, and screws. The screws are then periodically adjusted while the bone is healing to get the required shape. Once this has been completed a second operation is performed to remove the apparatus. An advantage of the Ilizarov method (i.e., a limb shaping procedure using the Ilizarov system) is that the Ilizarov system provides support while the bone is recovering thus enabling the patient to remain relatively active during the majority of the treatment.
The vibrational treatment entails using a vibrating inertia device. Other apparatus for creating resonant vibrations for vibrational treatment are described in U.S. patent application filed on Jul. 18, 2006 titled “Vibrational Therapy Assembly for Treating and Preventing the Onset of Deep Venous Thrombosis” and assigned U.S. patent application Ser. No. 11/488,227; U.S. patent application filed on Jul. 17, 2006 titled “Dynamic Motion Therapy Apparatus Having a Treatment Feedback Indicator” and assigned U.S. patent application Ser. No. 11/487,677; U.S. patent application filed on Mar. 24, 2006 titled “Apparatus and Method for Monitoring and Controlling the Transmissibility of Mechanical Vibration Energy During Dynamic Motion Therapy” and assigned U.S. patent application Ser. No. 11/388,286; and U.S. patent application filed on Mar. 6, 2006 titled “Supplemental Support Structures Adapted to Receive a Non-invasive Dynamic Motion Therapy Device” and assigned U.S. patent application Ser. No. 11/369,611; the entire contents of these U.S. patent applications are incorporated herein by reference.
The vibrational treatment is also known as dynamic motion therapy and its effects on the musculoskeletal system are described at www.juvent.com.
The present disclosure describes apparatuses and methods for combining limb shaping with vibrational treatment of bones. The apparatuses and methods according to the present disclosure are typically employed following a determination that vibrational treatment of a patient's bone following a limb shaping medical procedure would produce a beneficial result.
Several bone-related medical procedures which the apparatus and methods described herein can be used following the performance thereof include a procedure which entails providing a synthetic bone graft material or bone void filler to influence or facilitate bone ingrowth (see Walsh, W. R., et al., “Influence of Dynamic Motion Therapy on bone ingrowth into a bone graft substitute” which is submitted herewith and whose entire disclosure, including photographs, is a part of this provisional application); a procedure which entails stabilizing a bone fracture by inserting pins through the skin and the bone; a procedure which entails using external fixators for limb lengthening (distraction osteogenesis), limb straightening and/or limb shaping; a procedure which entails attaching a limb; a procedure which entails providing the patient with a cast, such as providing the patient with a cast surrounding a portion of a limb or an entire body cast; and joint fusion, a procedure which entails permanently fusing bones, such as in the case of an unnatural fracture of the ankle and spinal fusion procedures using spinal cages. The vibrational treatment apparatus and method can also be used following other bone-related medical procedures which are not listed above. Preferably, the bone-related medical procedure that the present disclosure relates to is a limb shaping procedure, such as may be performed using the Ilizarov method.
The Ilizarov method is a limb correction process for reshaping injured or deformed limbs, involving little invasive treatment. This method introduced the concept of law of tension-stress, which describes the process of new bone and soft tissue regeneration under the effect of slow and gradual distraction. It relies on the body's ability to heal itself through distraction osteogenesis.
In the first phase of the Ilizarov method, the surgeon performs a minimally invasive procedure, an osteotomy, in which the bone that is to be lengthened is cut.
In the second phase, distraction osteogenesis is achieved by surgically applying an external fixator and then creating a special fracture of the affected bone called a corticotomy. This bone cut is performed through a very small incision, leaving the surrounding muscle and periosteum, with its healing blood supply, attached to the bone. The external fixator is designed and built before surgery to match the existing deformity. It is attached to the limb through bone by thin steel wires and thick pins. The thin steel wires, preferably of 1.5 mm diameter, are passed percutaneously (through the skin) through bones by means of a drill. The protruding ends of these wires are then preferably fixed to rings with special wire-fixation bolts. These rings in turn are connected and fixed to one another by threaded rods. Once it is fixed, the Ilizarov frame affords a stable support to the affected limb.
In the third phase, postoperatively, under the direction of the surgeon, the patient gradually adjusts the fixator, slowly reshaping the bone to correct the length or deformity. As the bone segments separate, new bone tissue forms in the gap, ultimately assuming the strength of the original bone. It takes between 5 and 10 days for the body's natural inflammatory response to occur. As a result, the actual lengthening or straightening of the bone begins. During this time period, the patient or a family member adjusts the small wheel on the fixator at designated times during the day. Typically, the bone is pulled apart at a rate of 1 millimeter a day (about 1/25 of an inch) and the body's response is to grow new bone to fill the gap.
Referring to
The vibrational support 12 is configured to hold the energy moving device 14. The vibrational support 12 may be constructed by using any of a plurality of materials.
The energy moving device 14 is configured to vibrate for subjecting the musculoskeletal system, including the bone requiring treatment following a bone-related medical procedure, e.g., the Ilizarov method, to a vibrational stimulus while the patient is using the vibrational treatment apparatus 10. The energy moving device 14 preferably vibrates to produce resonant vibrations having a frequency suitable for treating bone, and is discussed in more detail infra. The resonant vibrations provide the vibrational stimulus at substantially the same frequency to the bone tissue. Vibrational treatment is preferably performed at a predetermined frequency for a predetermined period of time and for a predetermined treatment duration depending on one or more parameters. The parameters include the type of bone tissue requiring vibrational treatment, the location of the bone tissue, factors relating to the patient (age, sex, weight, postural stability, etc.), whether the patient has any abnormalities, and/or the condition of the patient and/or bone tissue (stiffness, brittleness, etc.) requiring vibrational treatment. At least one low-mass accelerometer 16 may be mounted to the vibrational treatment apparatus 10 on an outer side of the vibrational treatment apparatus 10 as described in U.S. Pat. No. 6,607,497, the contents of which are incorporated herein by reference. Accelerometer 16 is used to measure the vibrational response of the patient's musculoskeletal system to simultaneously determine postural stability of the patient, if so desired, using the method described in U.S. Pat. No. 6,607,497, while providing vibrational treatment to the bone in accordance with the present disclosure.
Therefore, the Ilizarov system 20 is used in surgical procedures to lengthen or reshape limb bones, such as the tibia 24. However, the Ilizarov system can be used on various bones of the human body. The surgical procedure is often used to treat complex and/or open bone fractures, where conventional treatment techniques cannot be used. The surgical procedure involves breaking the bone to be adjusted, for example the tibia 24. The at least two metal rings 28 are then attached to the bone sections by rods 30, wires 32, 34, and/or screws (not shown). The screws are then periodically adjusted while the bone is healing to get the required shape. Once this has been completed the fixator is removed.
Therefore, in the first embodiment of the present disclosure, the vibrational treatment apparatus 44 may be attached to any of the rods 30 that hold together the metal rings 28 (shown in
During treatment according to the method of the present disclosure, the vibrational treatment apparatus 44 is attached to the Ilizarov system 42. Vibrations generated by the energy moving device 14 (shown in
For example, for bones located in the leg of a person, the frequencies imparted by the vibration treatment apparatus 10 may be in the range between 30-90 Hz with a peak amplitude between 0.04 and 0.4 g for bones located in a patient's leg. Preferably, the frequency of the vibration treatment apparatus 10 is approximately 30 Hz and the peak amplitude is 0.3 g. However, the preferred frequencies may vary according to the limb or bone desired to be treated.
In addition, the vibration waves are preferably sinusoidal, however other waveforms are contemplated. Typically, the resonant vibrations provide the vibrational stimulus at substantially the same frequency to the bone tissue. The vibrational stimulus causes the bone tissue to shake or vibrate at a vibrational frequency for producing a beneficial healing effect. The method also includes the step of evaluating a healing response of the bone tissue. Preferably, the predetermined period of time is approximately ten minutes and the predetermined treatment duration is at least four weeks.
Therefore, in the second embodiment of the present disclosure, the vibrational treatment apparatuses 54, 56 may be attached to the rods in a similar manner as the metal rings 28 are attached to the Ilizarov system 40 show by
Referring to
A third magnet 66 is placed in between the two electromagnets 62, 64 in order to obtain linear vibration (or rotational or semi-circular vibration where the vibrational treatment apparatus has a circular configuration as shown in
In another embodiment, the energy moving device may be selected from the group consisting of speakers, air moving devices (blowers and fans) and sub-woofers, or combinations thereof. Preferably, the energy moving device includes a plurality of speakers positioned near the bone tissue to be treated. The plurality of speakers may generate low frequency waves in a manner described hereinabove. Moreover, each speaker may be configured to generate waves having a frequency different from the frequencies of the waves generated by the other speakers. Accordingly, bone tissue can be subjected to a vibrational stimulus produced by waves having frequencies (delivering broadband of signals).
In another embodiment, the energy moving device may also be a spring loaded solenoid for creating the required vibration. The spring mechanism may be a motorized or a non-motorized spring mechanism, which causes the vibrational support 12 (shown in
Referring to
Referring to
Referring to
During vibrational treatment, the energy moving device 60 generates vibratory energy which is focused to the bone requiring vibrational treatment in accordance with the method of the present disclosure. The at least one energy moving device 60 may generate waves having a frequency in the range of 1 Hz to 100 KHz. The waves, as the resonant vibrations described above, provide a vibrational stimulus at substantially the same frequency to the bone tissue being treated. Vibrational treatment using the at least one energy moving device 60 is preferably performed at a predetermined frequency for a predetermined period of time and for a predetermined treatment duration depending on one or more parameters. The parameters include the type of bone tissue requiring vibrational treatment, the location of the bone tissue, factors relating to the patient (age, sex, weight, postural stability, etc.), whether the patient has any abnormalities, and/or the condition of the patient and/or bone tissue (stiffness, brittleness, etc.) requiring vibrational treatment. For example, the predetermined frequency is 30 Hz, the predetermined period of time is ten minutes and the predetermined treatment duration is approximately four weeks for bones located in a patient's leg. However, the predetermined period of time may vary depending on the limb receiving treatment.
Furthermore, the method may also include the step of evaluating a healing response of the bone tissue and adjusting at least one of the predetermined period of time and the predetermined treatment duration accordingly. In the apparatus and method in accordance with the present disclosure, the vibrational stimulus provided by the vibratory energy causes the patient and the bone tissue to shake or vibrate for producing a beneficial healing effect for the bone tissue. In addition, the vibrational response is measured and recorded by a spectrum analyzer/computer (not shown) which is electrically connected to the accelerometer 16.
While the methods of the present disclosure utilize a vibrational treatment apparatus as described and shown by the various figures as the fundamental perturbing agent for vibrating the musculoskeletal system, including the bone tissue which has undergone a bone-related medical procedure, it is contemplated that any other apparatus or method can be employed for providing the vibrational stimulus required for vibrationally treating the bone tissue in accordance with the methodology of the present disclosure.
This application is a continuation-in-part application from an application filed on Dec. 4, 2007 and assigned U.S. patent application Ser. No. 11/950,368 which claims priority to a U.S. provisional application filed on Dec. 7, 2006 and assigned U.S. Provisional Application Ser. No. 60/873,327; the contents of both applications are incorporated herein by reference.
Number | Date | Country | |
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60873327 | Dec 2006 | US |
Number | Date | Country | |
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Parent | 11950368 | Dec 2007 | US |
Child | 11951876 | US |