Patent Grant
11504162
Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application are hereby incorporated by reference under 37 CFR 1.57.
The field of the invention generally relates to medical devices for treating disorders of the skeletal system.
Scoliosis is a general term for the sideways (lateral) curving of the spine, usually in the thoracic or thoracolumbar region. Scoliosis is commonly broken up into different treatment groups, Adolescent Idiopathic Scoliosis, Early Onset Scoliosis and Adult Scoliosis.
Adolescent Idiopathic Scoliosis (AIS) typically affects children between ages 10 and 16, and becomes most severe during growth spurts that occur as the body is developing. One to two percent of children between ages 10 and 16 have some amount of scoliosis. Of every 1000 children, two to five develop curves that are serious enough to require treatment. The degree of scoliosis is typically described by the Cobb angle, which is determined, usually from x-ray images, by taking the most tilted vertebrae above and below the apex of the curved portion and measuring the angle between intersecting lines drawn perpendicular to the top of the top vertebrae and the bottom of the bottom. The term idiopathic refers to the fact that the exact cause of this curvature is unknown. Some have speculated that scoliosis occurs when, during rapid growth phases, the ligamentum flavum of the spine is too tight and hinders symmetric growth of the spine. For example, as the anterior portion of the spine elongates faster than the posterior portion, the thoracic spine begins to straighten, until it curves laterally, often with an accompanying rotation. In more severe cases, this rotation actually creates a noticeable deformity, wherein one shoulder is lower than the other. Currently, many school districts perform external visual assessment of spines, for example in all fifth grade students. For those students in whom an “S” shape or “C” shape is identified, instead of an “I” shape, a recommendation is given to have the spine examined by a physician, and commonly followed-up with periodic spinal x-rays.
Typically, patients with a Cobb angle of 20° or less are not treated, but are continually followed up, often with subsequent x-rays. Patients with a Cobb angle of 40° or greater are usually recommended for fusion surgery. It should be noted that many patients do not receive this spinal assessment, for numerous reasons. Many school districts do not perform this assessment, and many children do not regularly visit a physician, so often, the curve progresses rapidly and severely. There is a large population of grown adults with untreated scoliosis, in extreme cases with a Cobb angle as high as or greater than 90°. Many of these adults, though, do not have pain associated with this deformity, and live relatively normal lives, though oftentimes with restricted mobility and motion. In AIS, the ratio of females to males for curves under 10° is about one to one, however, at angles above 30°, females outnumber males by as much as eight to one. Fusion surgery can be performed on the AIS patients or on adult scoliosis patients. In a typical posterior fusion surgery, an incision is made down the length of the back and Titanium or stainless steel straightening rods are placed along the curved portion. These rods are typically secured to the vertebral bodies, for example with hooks or bone screws, or more specifically pedicle screws, in a manner that allows the spine to be straightened. Usually, at the section desired for fusion, the intervertebral disks are removed and bone graft material is placed to create the fusion. If this is autologous material, the bone is harvested from a hip via a separate incision.
Alternatively, the fusion surgery may be performed anteriorly. A lateral and anterior incision is made for access. Usually, one of the lungs is deflated in order to allow access to the spine from this anterior approach. In a less-invasive version of the anterior procedure, instead of the single long incision, approximately five incisions, each about three to four cm long are made in several of the intercostal spaces (between the ribs) on one side of the patient. In one version of this minimally invasive surgery, tethers and bone screws are placed and are secured to the vertebra on the anterior convex portion of the curve. Currently, clinical trials are being performed which use staples in place of the tether/screw combination. One advantage of this surgery in comparison with the posterior approach is that the scars from the incisions are not as dramatic, though they are still located in a visible area, when a bathing suit, for example, is worn. The staples have had some difficulty in the clinical trials. The staples tend to pull out of the bone when a critical stress level is reached.
In some cases, after surgery, the patient will wear a protective brace for a few months as the fusing process occurs. Once the patient reaches spinal maturity, it is difficult to remove the rods and associated hardware in a subsequent surgery, because the fusion of the vertebra usually incorporates the rods themselves. Standard practice is to leave this implant in for life. With either of these two surgical methods, after fusion, the patient's spine is now straight, but depending on how many vertebra were fused, there are often limitations in the degree of flexibility, both in bending and twisting. As these fused patients mature, the fused section can impart large stresses on the adjacent non-fused vertebra, and often, other problems including pain can occur in these areas, sometimes necessitating further surgery. This tends to be in the lumbar portion of the spine that is prone to problems in aging patients. Many physicians are now interested in fusionless surgery for scoliosis, which may be able to eliminate some of the drawbacks of fusion.
One group of patients in which the spine is especially dynamic is the subset known as Early Onset Scoliosis (EOS), which typically occurs in children before the age of five, and more often in boys than in girls. This is a more rare condition, occurring in only about one or two out of 10,000 children, but can be severe, sometimes affecting the normal development of organs. Because of the fact that the spines of these children will still grow a large amount after treatment, non-fusion distraction devices known as growing rods and a device known as the EPTRVertical Expandable Prosthetic Titanium Rib (“Titanium Rib”) have been developed. These devices are typically adjusted approximately every six months, to match the child's growth, until the child is at least eight years old, sometimes until they are 15 years old. Each adjustment requires a surgical incision to access the adjustable portion of the device. Because the patients may receive the device at an age as early as six months old, this treatment requires a large number of surgeries. Because of the multiple surgeries, these patients have a rather high preponderance of infection.
Returning to the AIS patients, the treatment methodology for those with a Cobb angle between 20° and 40° is quite controversial. Many physicians proscribe a brace (for example, the Boston Brace), that the patient must wear on their body and under their clothes 18 to 23 hours a day until they become skeletally mature, for example to age 16. Because these patients are all passing through their socially demanding adolescent years, it is quite a serious prospect to be forced with the choice of either wearing a somewhat bulky brace that covers most of the upper body, having fusion surgery that may leave large scars and also limit motion, or doing nothing and running the risk of becoming disfigured and possibly disabled. It is commonly known that many patients have at times hidden their braces, for example, in a bush outside of school, in order to escape any related embarrassment. The patient compliance with brace wearing has been so problematic that there have been special braces constructed which sense the body of the patient, and keep track of the amount of time per day that the brace is worn. Patients have even been known to place objects into unworn braces of this type in order to fool the sensor. Coupled with the inconsistent patient compliance with brace usage, is a feeling by many physicians that braces, even if used properly, are not at all effective at curing scoliosis. These physicians may agree that bracing can possibly slow down or even temporarily stop curve (Cobb angle) progression, but they have noted that as soon as the treatment period ends and the brace is no longer worn, often the scoliosis rapidly progresses, to a Cobb angle even more severe than it was at the beginning of treatment. Some say the reason for the supposed ineffectiveness of the brace is that it works only on a portion of the torso, and not on the entire spine. Currently a prospective, randomized 500 patient clinical trial known as BrAIST (Bracing in Adolescent Idiopathic Scoliosis Trial) is enrolling patients, 50% of whom will be treated with the brace and 50% of who will simply be watched. The Cobb angle data will be measured continually up until skeletal maturity, or until a Cobb angle of 50° is reached, at which time the patient will likely undergo surgery. Many physicians feel that the BrAIST trial will show that braces are completely ineffective. If this is the case, the quandary about what to do with AIS patients who have a Cobb angle of between 20° and 40° will only become more pronounced. It should be noted that the “20° to 40°” patient population is as much as ten times larger than the “40° and greater” patient population.
Distraction osteogenesis, also known as distraction callotasis and osteodistraction has been used successfully to lengthen long bones of the body. Typically, the bone, if not already fractured, is purposely fractured by means of a corticotomy, and the two segments of bone are gradually distracted apart, which allows new bone to form in the gap. If the distraction rate is too high, there is a risk of nonunion, if the rate is too low, there is a risk that the two segments will completely fuse to each other before the distraction period is complete. When the desired length of the bone is achieved using this process, the bone is allowed to consolidate. Distraction osteogenesis applications are mainly focused on the growth of the femur or tibia, but may also include the humerus, the jaw bone (micrognathia), or other bones. The reasons for lengthening or growing bones are multifold, the applications including, but not limited to: post osteosarcoma bone cancer; cosmetic lengthening (both legs-femur and/or tibia) in short stature or dwarfism/achondroplasia; lengthening of one limb to match the other (congenital, post-trauma, post-skeletal disorder, prosthetic knee joint), nonunions.
Distraction osteogenesis using external fixators has been done for many years, but the external fixator can be unwieldy for the patient. It can also be painful, and the patient is subject to the risk of pin track infections, joint stiffness, loss of appetite, depression, cartilage damage and other side effects. Having the external fixator in place also delays the beginning of rehabilitation.
In response to the shortcomings of external fixator distraction, intramedullary distraction nails have been surgically implanted which are contained entirely within the bone. Some are automatically lengthened via repeated rotation of the patient's limb. This can sometimes be painful to the patient, and can often proceed in an uncontrolled fashion. This therefore makes it difficult to follow the strict daily or weekly lengthening regime that avoids nonunion (if too fast) or early consolidation (if too slow). Lower limb distraction rates are on the order of one mm per day. Other intramedullary nails have been developed which have an implanted motor and are remotely controlled by an antenna. These devices are therefore designed to be lengthened in a controlled manner, but due to their complexity, may not be manufacturable as an affordable product. Others have proposed intramedullary distractors containing and implanted magnet, which allows the distraction to be driven electromagnetically by an external stator. Because of the complexity and size of the external stator, this technology has not been reduced to a simple and cost-effective device that can be taken home, to allow patients to do daily lengthenings.
In one embodiment, an external adjustment device includes at least one permanent magnet configured for rotation about an axis. The external adjustment device further includes a first handle extending linearly at a first end of the device and a second handle disposed at a second end of the device, the second handle extending in a direction that is angled relative to the first handle. The external adjustment device includes a motor mounted inside the first handle and a first button located in the proximity to one of the first handle or the second handle, the first button configured to be operated by the thumb of a hand that grips the one of the first handle or second handle. The first button is configured to actuate the motor causing the at least one permanent magnet to rotate about the axis in a first direction.
In another embodiment, an external adjustment device includes at least one permanent magnet configured for rotation about an axis and a motor configured for rotating the at least one permanent magnet about the axis. The external adjustment device includes a first handle extending linearly at a first end of the device and a second handle disposed at a second end of the device, the second handle extending in a direction that is substantially off axis with respect to the first handle, wherein one of the first and second handle comprises a looped shape. A first drive button is located in the proximity to one of the first handle or the second handle, the first drive button configured to be operated by the thumb of a hand that grips the one of the first handle or second handle. The first drive button is configured to actuate the motor causing the at least one permanent magnet to rotate about the axis in a first direction.
Distraction turns the magnets 706, 708 one direction and retraction turns the magnets 706, 708 in the opposite direction. Magnets 706, 708 have stripes 809 that can be seen in window 811. This allows easy identification of whether the magnets 706, 708 are stationary or turning, and in which direction they are turning. This allows quick trouble shooting by the operator of the device. The operator can determine the point on the patient where the magnet of the distraction device 1000 is implanted, and can then put the external adjustment device 700 in correct location with respect to the distraction device 1000, by marking the corresponding portion of the skin of the patient, and then viewing this spot through the alignment window 716 of the external adjustment device 700.
A control panel 812 includes several buttons 814, 816, 818, 820 and a display 715. The buttons 814, 816, 818, 820 are soft keys, and able to be programmed for an array of different functions. In one configuration, the buttons 814, 816, 818, 820 have corresponding legends which appear in the display. To set the length of distraction to be performed on the distraction device 1000, the target distraction length 830 is adjusted using an increase button 814 and a decrease button 816. The legend with a green plus sign graphic 822 corresponds to the increase button 814 and the legend with a red negative sign graphic 824 corresponds to the decrease button 816. It should be understood that mention herein to a specific color used for a particular feature should be viewed as illustrative. Other colors besides those specifically recited herein may be used in connection with the inventive concepts described herein. Each time the increase button 814 is depressed, it causes the target distraction length 830 to increase 0.1 mm. Each time the decrease button 816 is depressed it causes the target distraction length 830 to decrease 0.1 mm. Of course, other decrements besides 0.1 mm could also be used. When the desired target distraction length 830 is displayed, and the external adjustment device 700 is correctly placed on the patient, the operator then holds down the distraction button 722 and the External Distraction Device 700 operates, turning the magnets 706, 708, until the target distraction length 830 is achieved. Following this, the external adjustment device 700 stops. During the distraction process, the actual distraction length 832 is displayed, starting at 0.0 mm and increasing until the target distraction length 830 is achieved. As the actual distraction length 832 increases, a distraction progress graphic 834 is displayed. For example a light colored box 833 that fills with a dark color from the left to the right. In
The two handles 702, 704 can be held in several ways. For example the first handle 702 can be held with palm facing up while trying to find the location on the patient of the implanted magnet of the distraction device 1000. The fingers are wrapped around the handle 702 and the fingertips or mid-points of the four fingers press up slightly on the handle 702, balancing it somewhat. This allows a very sensitive feel that allows the magnetic field between the magnet in the distraction device 1000 and the magnets 706, 708 of the external adjustment device 700 to be more obvious. During the distraction of the patient, the first handle 702 may be held with the palm facing down, allowing the operator to push the device down firmly onto the patient, to minimize the distance between the magnets 706, 708 of the external adjustment device and the magnet 1010 of the distraction device 1000, thus maximizing the torque coupling. This is especially appropriate if the patient is large or somewhat obese. The second handle 704 may be held with the palm up or the palm down during the magnet sensing operation and the distraction operation, depending on the preference of the operator.
Independently, Hall effect sensors 924, 926, 928, 930, 932, 934, 936, 938 may be used as non-optical encoders to track rotation of one or both of the external magnets 706, 708. While eight (8) such Hall effect sensors are illustrated in
If independent stepper motors are used, the resynchronization process may simply be one of reprogramming, but if the two external magnets 706, 708 are coupled together, by gearing or belt for example, then a mechanical rework may be required. An alternative to the Hall effect sensor configuration of
Returning to
In still another embodiment, additional information may be processed by processor 915 and may be displayed on display 715. For example, distractions using the external adjustment device 700 may be performed in a doctor's office by medical personnel, or by patients or members of patient's family in the home. In either case, it may be desirable to store information from each distraction session that can be accessed later. For example, the exact date and time of each distraction, and the amount of distraction attempted and the amount of distraction obtained. This information may be stored in the processor 915 or in one or more memory modules (not shown) associated with the processor 915. In addition, the physician may be able to input distraction length limits, for example the maximum amount that can be distracted at each session, the maximum amount per day, the maximum amount per week, etc. The physician may input these limits by using a secure entry using the keys or buttons of the device, that the patient will not be able to access.
Returning to
For example, the motor 705 would be commanded to rotate the magnets 706, 708 in a first direction when distracting an antegrade placed distraction device 1000, and in a second, opposite direction when distracting a retrograde placed distraction device 1000. The physician may, for example, be prompted by the display 715 to input using the control panel 812 whether the distraction device 1000 was placed antegrade or retrograde. The patient may then continue to use the same external adjustment device 700 to assure that the motor 705 turns the magnets 706, 708 in the proper directions for both distraction and retraction. Alternatively, the distraction device may incorporate an RFID chip 1022 which can be read and written to by an antenna 1024 on the external adjustment device 700. The position of the distraction device 1000 in the patient (antegrade or retrograde) is written to the RFID chip 1022, and can thus be read by the antenna 1024 of any external adjustment device 700, allowing the patient to get correct distractions or retractions, regardless of which external adjustment device 700 is used.
As explained above, with respect to
Each of the first external magnet 706 and second external magnet 708 defines its own vertical axis, perpendicular to the horizontal axis 1110 and through the magnet's elongate rotational axis. First external magnet 706 has a first magnet vertical axis 1113 that is perpendicular to the horizontal axis 1110 and intersects the first elongate rotational axis (i.e., the horizontal axis 1110 and the first magnet vertical axis 1113 intersect at the center of the circle defined by any plane perpendicular to the longitudinal axis of the first external magnet 706). In the same way, second external magnet 708 has a second magnet vertical axis 1112 that is perpendicular to the horizontal axis 1110 and intersects the second elongate rotational axis (i.e., the horizontal axis 1110 and the second magnet vertical axis 1112 intersect at the center of the circle defined by any plane perpendicular to the longitudinal axis of the second external magnet 708).
The first external magnet 706 and the second external magnet 708 are separated by an intermagnet gap 1130, which is defined as the distance along the horizontal axis 1110 between the rightmost edge of the first external magnet 706 and the leftmost edge of the second external magnet 708. A central vertical axis 1111 bisects the horizontal axis 1110 in the center of the intermagnet gap 1130, perpendicular to the horizontal axis 1110. Therefore, the distance from the center of the first external magnet 706 (i.e., the first elongate rotational axis) to the center of the second external magnet 708 (i.e., the second elongate rotational axis) is equal to one half the first magnet diameter 1134 plus one half the second magnet diameter 1132 plus the intermagnet gap 1130. When the first magnet diameter 1134 of the first external magnet 706 and second magnet diameter 1132 of the second external magnet 708 are equal, as shown in
An ideal reference location for the implanted magnet 1010 is on the central vertical axis 1111. In the case where first magnet diameter 1134 and second magnet diameter 1132 are equal, the first external magnet 706 and second external magnet 708 create equal magnetic fields. Therefore, any point along central vertical axis 1111 will experience equal effects by first external magnet 706 and second external magnet 708. The distance between the lowermost edge of the external magnets (i.e., first external magnet 706 and second external magnet 708) and the uppermost edge of the implanted magnet 1010 is defined as the gap distance 1138. It should be understood that, while a reference location for the implanted magnet 1010 on the central vertical axis 1111 is conceptually helpful, the implanted magnet 1010 may also lie off the central vertical axis 1111.
Turning to
The intermagnet gap 1130 can have an effect on the magnetic flux density observed along the central vertical axis 1111. Magnetic flux density drops off at approximately 1/r3 (an inverse cube). Therefore, a very small gap distance may observe relatively high flux densities along the central vertical axis 1111. By contrast, because of how quickly the flux density drops off, a lower limit of flux density is reached relatively quickly with medium and large intermagnet gaps 1130.
Turning again to
As can be seen, in applications for which a small gap distance is possible or required, intermagnet gap may be varied to increase or decrease the flux density. If higher flux densities are useful or required (such as when higher torques are useful or required), the intermagnet gap may be decreased while holding the gap distance constant—i.e., first external magnet 706 and the second external magnet 708 may be brought closer together on horizontal axis 1110. By contrast, if lower flux densities are useful or required (such as when high torques are not needed or could be detrimental), the intermagnet gap may be increased while holding the gap distance constant—i.e., the first external magnet 706 and the second external magnet 708 may be moved apart on the horizontal axis 1110. Of course, both intermagnet gap and gap distance may be varied.
In some embodiments, the external adjustment device 700 may be “smart” and able to vary the intermagnet gap based one or more factors, such as, but not limited to, user input and a sensed parameter. Therefore, such a “smart” external adjustment device 700 may manipulate intermagnet gap to increase or decrease the flux density as needed. For example, a user may input several parameters that allow the external adjustment device to select the appropriate intermagnet gap distance for the given application. Such variable may include implant location, patient age, patient weight, patient body mass index (BMI), gap distance, etc. By contrast to input parameters, a “smart” external adjustment device 700 may be able to use sensed parameters such as gap distance magnetic coupling slippage, torque generated, force generated, etc.
In response to one or more of these user inputs and sensed parameters, the intermagnet gap may be adjusted. In some embodiments, the external adjustment device 700 may inform a user that a given adjustment could improve treatment efficacy. In such a case, the user could use any of a number of tools, systems, and methods to increase the intermagnet gap. Alternatively, a “smart” external adjustment device 700 may process the user inputs and/or sensed parameters, determine that a change (increase or decrease) in flux density or torque generation would be advantageous, and automatically adjust the intermagnet gap to the optimum intermagnet gap that remains within system capabilities (i.e., due to physical constraints, there are both lower and upper limits on the intermagnet gap).
As explained with reference to
Turning again to
In its reference orientation, shown in both
The first external magnet 706 may be rotated to an example first central magnetic axis 1122′ by a first angle of rotation 1123. In some embodiments, as just mentioned, the first angle of rotation 1123 is positive, and in some embodiments the first angle of rotation 1123 is negative. The first angle of rotation 1123 may rotate the first central magnetic axis 1122 in a positive direction from 0° to 360°. Additionally, the first angle of rotation 1123 may rotate the first central magnetic axis 1122 in a negative direction from 0° to −360°. Rotations of the first external magnet 706 such that the first central magnetic axis 1122 is rotationally offset by a first angle of rotation 1123 of >0° to <180° are uniquely positive rotational offsets. In the same way, rotations of the first external magnet 706 such that the first central magnetic axis 1122 is rotationally offset by first angle of rotation 1123 of <0° to >−180° are uniquely negative rotational offsets. As will be readily understood, rotations of the first external magnet 706 by a first angle of rotation 1123 of >180° to <360° are equivalent to rotations of the first external magnet 706 by a first angle of rotation 1123 of <0° to >−180°, and rotations of the first external magnet 706 by a first angle of rotation 1123 of <−180° to <−360° are equivalent to rotations of the first external magnet 706 by a first angle of rotation 1123 of >0° to <180°. Rotations of the first external magnet 706 by a first angle of rotation 1123 of >0° to <180° are uniquely positive rotational offsets that are known as “upward rotations” or “upward offsets.” By contrast, rotations of the first external magnet 706 by a first angle of rotation 1123 of <0° to >−180° are uniquely negative rotational offsets that are known as “downward rotations” or “downward offsets.”
The second external magnet 708 may also have a rotational offset. The second external magnet 708 may be rotated to an example second central magnetic axis 1120′ by a second angle of rotation 1121. In some embodiments, the second angle of rotation 1121 is positive, and in some embodiments the second angle of rotation 1121 is negative. The second external magnet 708, including the second central magnetic axis 1120, may be rotated by a second angle of rotation 1121 in a positive direction from 0° to 360°. Additionally, the second external magnet 708, including the second central magnetic axis 1120, may be rotated by a second angle of rotation 1121 in a negative direction from 0° to −360°. Rotations of the second external magnet 708 such that the second central magnetic axis 1120 is rotationally offset by a second angle of rotation 1121 of >0° to <180° are uniquely positive rotational offsets. In the same way, rotations of the second external magnet 708 such that the second central magnetic axis 1120 is rotationally offset by second angle of rotation 1121 of <0° to >−180° are uniquely negative rotational offsets. As discussed with respect to the first external magnet 706, rotations of the second external magnet 708 by a second angle of rotation 1121 of >180° to <360° are equivalent to rotations of the second external magnet 708 by a second angle of rotation 1121 of <0° to >−180°, and rotations of the second external magnet 708 by a second angle of rotation 1121 of <−180° to <−360° are equivalent to rotations of the second external magnet 708 by a second angle of rotation 1121 of >0° to <180°. Rotations of the second external magnet 708 by a second angle of rotation 1121 of >0° to <180° are uniquely positive rotational offsets that are known as “upward rotations” or “upward offsets.” By contrast, rotations of the second external magnet 708 by a second angle of rotation 1121 of <0° to >−180° are uniquely negative rotational offsets that are known as “downward rotations” or “downward offsets.”
Either one or both magnets may be rotationally offset. In some embodiments, only the first external magnet 706 is rotated in one of a positive and a negative direction (i.e., upward rotation or downward rotation). In other embodiments, only the second external magnet 708 is rotated in one of a positive and a negative direction (i.e., upward rotation or downward rotation). In yet other embodiments, both magnets are rotated. Any permutation of dual magnet rotation is possible: both first external magnet 706 and second external magnet 708 being rotated upward (by equal or different amounts); both first external magnet 706 and second external magnet 708 being rotated downward (by equal or different amounts); first external magnet 706 being rotated upward while second external magnet 708 being rotated downward (by equal or different amounts); and first external magnet 706 being rotated downward while second external magnet 708 being rotated upward (by equal or different amounts). When both the first external magnet 706 and the second external magnet 708 are rotated equally upward, the rotational systemic offset is the sum of the magnitude of the two offsets. For example, when the first external magnet 706 has an upward rotation of 40° and the second external magnet 708 has a rotation of 40°, the system's rotation is termed, for example, an “upward 80°” or “80° upward.” In the same fashion, if the first external magnet 706 has a downward rotation of −15° and the second external magnet 708 has a downward rotation of −15°, the system's rotation is termed, for example, a “downward 30°” or “30° downward.”
Depending on the point on the central vertical axis 1111, changing the rotational offset of one or both the first external magnet 706 and the second external magnet 708 may either increase or decrease the observed flux density for a given gap distance 1138. For example, as will be discussed in greater detail, below, an upward rotational offset (i.e., >0° to <180°) generally increases flux density on the central vertical axis 1111 at a given gap distance 1138. By contrast, a downward offset (i.e., <0° to >−180°) generally decreases flux density on the central vertical axis 1111 at a given gap distance 1138 (however, downward offsets may increase flux density on the central vertical axis 1111 at small gap distances 1138). Once the first external magnet 706 and second external magnet 708 are unilaterally or bilaterally rotated out of phase in either an upward or a downward direction, they may be rotationally locked with respect to each other and rotated as described above (e.g., at the same angular velocity).
By contrast to
First line 2310 is a plot of magnetic flux density versus gap distance for a two magnet system (e.g., a system having a first external magnet 706 and a second external magnet 708) in which the magnets have a intermagnet gap of 0.75 inches and no angular offset (i.e., neither the first external magnet 706 nor the second external magnet 708 is rotated out of phase). An example flux map of such a system is shown in
Second line 2320 is a plot of magnetic flux density versus gap distance for a two magnet system (e.g., a system having a first external magnet 706 and a second external magnet 708) in which the magnets have an intermagnet gap of 0.75 inches and a systemic angular offset of an upward 40 degrees (i.e., each of first external magnet 706 and second external magnet 708 has an upward rotation of 20 degrees). An example flux map of such a system is shown in
Third line 2330 is a plot of magnetic flux density versus gap distance for a two magnet system (e.g., a system having a first external magnet 706 and a second external magnet 708) in which the magnets have an intermagnet gap of 0.75 inches and a systemic angular offset of a downward 40 degrees (i.e., each of the first external magnet 706 and the second external magnet 708 has a downward rotation of 20 degrees). An example flux map of such a system is shown in
Finally, fourth line 2340 is a plot of magnetic flux density versus gap distance for a two magnet system (e.g., a system having a first external magnet 706 and a second external magnet 708) in which the magnets have an intermagnet gap of 0.75 inches and a systemic angular offset of a downward 80 degrees (i.e., each of the first external magnet 706 and the second external magnet 708 has a downward rotation of 40 degrees). An example flux map of such a system is shown in
As just mentioned, the two magnet system that produced first line 1510 and second line 1520 have a zero degree rotational offset. However, the first two magnet system that produced first line 1510 had an intermagnet gap of about 0.2 inches whereas the second two magnet system that produced second line 1520 had an intermagnet gap of about 0.75 inches. The system in which the magnets were closer together initially has a significantly higher flux density than the system in which the magnets were farther apart—in fact, it is approximately 30% higher at a gap distance of zero. The graph illustrates that the gains achieved through small intermagnet gaps are realized at only relatively short gap distance. The first line 1510 and the second line 1520 substantially converge at about 30 mm, after which they remain approximately equal. This is entirely consistent with
As discussed above, and by contrast to the zero rotational offset system just discussed, the two magnet system that produced third line 1530 and fourth line 1540 have a systemic downward 80 degree rotational offset. However, the first two magnet system that produced third line 1530 had an intermagnet gap of about 0.2 inches whereas the second two magnet system that produced fourth line 1540 had an intermagnet gap of about 0.75 inches. The system in which the magnets were closer together initially had a significantly higher flux density than the system in which the magnets were farther apart—in fact, it is approximately 70% higher at a gap distance of zero. The graph illustrates that the gains achieved through small intermagnet gaps in systems having a downward rotational offset are realized across a much broader range of gap distances than for systems having no rotational offset. As mentioned above, systems having no rotational offset maintain an increased flux density only for gap distances lower than about 25 mm. By marked contrast, the system having a downward 80 degree rotational offset still experienced an increased flux density at about 50 mm—twice the gap distance. The rotationally offset systems converged at about 50 mm at which point in time they continued to track each other. However, they remain above the systems having no rotational offset.
It will also be understood that there are some applications in which small gap distances are uncommon if not impossible, and where medium to large gap distances must be addressed. An instance of such an application is in magnetically adjustable intramedullary femoral nails. Such nails are placed in the intramedullary canal of the femur; consequently, while adipose, fascia, and muscle may be compressed to some degree, the gap distance is substantially increased by the tissues overlying the femur. Some examples of such devices are disclosed in U.S. Pat. Nos. 8,449,543 and 8,852,187, which are incorporated by reference in their entirety herein. As noted above, a downward rotational offset generally causes an increase in flux density as gap distance increases. Therefore, in these applications, downward rotational offset systems will likely be more effective than their aligned counterparts. For systems having a downward rotational offset of 80 degrees, any increase in flux density due to decreased intermagnet gap is generally lost by about 50 mm. Therefore, if an application for which increased torque (and therefore flux density) is desirable, has a gap distance of greater than about 50 mm, decreasing the intermagnet gap will play very little role in increasing torque. However, if the gap distance is less than about 50 mm, decreasing the gap distance could dramatically increase the possible torque. While it is unlikely that any femoral intramedullary nail would ever experience a small gap distance, if the gap distance is smaller than about 25 mm, having a downward rotational offset would degrade the system's ability to generate higher torques. In that case, a rotationally aligned system having a small gap distance would be better. It should be noted that the effects of rotational offset and intermagnet gap have been discussed here in only a very limited context, and for example's sake only. As is discussed herein there are additional ranges and variables that may be altered to either increase or decrease the magnetic flux density experienced at a given point.
With continued reference to
The third external magnet 2408 may be rotated by a third angle of rotation 2425 to a third central magnetic axis 2424 (shown in
While
In addition to simple magnets, such as a compass, a horseshoe magnet, or even a rotational poled cylindrical magnet such as the first external magnet 706 and second external magnet 708, it is possible to create complex magnets in which the flux direction for each pole may be selected at will. A common example of a complex magnet is the refrigerator magnet in which magnetism exists only on one side—the back of the magnet will stick to a refrigerator while the front will not. This phenomenon is due to selective orientation of the flux direction during construction of the magnet that allows magnetic field to only to be present on one side of the magnet. The phenomenon is known as the Halbach effect and the arrangement known as a Halbach array. Straight magnets may be created in Halbach arrays so that a magnetic field exists on only one side by simply arranging north-south poled pieces side-by-side so that each consecutive piece's north pole has been rotated a quarter turn from the previous magnet. Once aligned as described, the direction of magnetization will be rotating uniformly as you progress in a particular direction.
Generally a Halbach array is an arrangement of permanent magnets that can augment the magnetic field on one side of the Halbach array while canceling the magnetic field to near zero or substantially near zero on the other side of the Halbach array. For example, the magnetic field can be enhanced on the bottom side of the Halbach array and cancelled on the top side (a one-sided flux) of the Halbach array. The quarter turn rotating pattern of permanent magnets can be continued indefinitely and have the same effect. Increasingly complex Halbach arrays may be used to shape the magnetic field for any magnet, including cylindrical magnets.
The International Commission on Non-Ionizing Radiation Protection has issued “Guidelines for Limiting Exposure to Time-Varying Electric, Magnetic, and Electromagnetic Fields (Up To 300 GHz)” and “Guidelines on Limits of Exposure to Static Magnetic Fields.” Both sets of guidelines are incorporated by reference in their entirety herein. These guidelines limit exposure to both time-varying magnetic fields and static magnetic fields to protect health. The limits are, however, different for different areas of the body. For example, a finger may have a higher limit than the brain. For time varying magnetic field limits, two variables are particularly important: field strength and field movement speed (e.g., with respect to the body). A weak magnetic field could generally be moved around the body relatively quickly while staying within the prescribed limits. By contrast, a very strong magnet would need to be move very slowly around the body to stay within the prescribed limits. This is one reason that patients undergoing MRI scans are told not to move—they are being subjected to incredibly strong magnetic fields. Much movement by a person in an MRI machine would likely exceed the prescribed limits. By contrast to time varying magnetic field limits, static field limits are concerned primarily with field strength. However, the guidelines note that they “do not apply to the exposure of patients undergoing medical diagnosis or treatment.” If they did apply, it is almost certain that MRI machines would fall outside the limits.
In view of the guidelines discussed above, it can be seen that magnetic medical devices should ideally use the weakest magnetic field possible in the slowest manner possible to still achieve the desired clinical outcome. Several of the systems disclosed herein, including the external adjustment device 700 shown in
Parameters that may be varied by a user in an external adjustment device 700 or by a “smart” external adjustment device 700 itself, include: intermagnet gap; gap distance; rotational offset (unilateral and bilateral); and magnet rotational velocity. Selectively varying one or more of these variable may allow the user or the “smart” external adjustment device 700 to optimize the system to have the lowest flux (weakest magnetic field) that is still clinically effective.
Although this invention has been disclosed in the context of certain preferred embodiments and examples, it will be understood by those skilled in the art that the present invention extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the invention and obvious modifications and equivalents thereof. In addition, while a number of variations of the invention have been shown and described in detail, other modifications, which are within the scope of this invention, will be readily apparent to those of skill in the art based upon this disclosure. It is also contemplated that various combinations or sub-combinations of the specific features and aspects of the embodiments may be made and still fall within the scope of the invention. Accordingly, it should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the disclosed invention. Thus, it is intended that the scope of the present invention herein disclosed should not be limited by the particular disclosed embodiments described above, but should be determined only by a fair reading of the claims that follow.
Similarly, this method of disclosure, is not to be interpreted as reflecting an intention that any claim require more features than are expressly recited in that claim. Rather, as the following claims reflect, inventive aspects lie in a combination of fewer than all features of any single foregoing disclosed embodiment. Thus, the claims following the Detailed Description are hereby expressly incorporated into this Detailed Description, with each claim standing on its own as a separate embodiment.
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| Number | Date | Country | |
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| 20210100588 A1 | Apr 2021 | US |
| Number | Date | Country | |
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| 62276196 | Jan 2016 | US | |
| 62265430 | Dec 2015 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 16004099 | Jun 2018 | US |
| Child | 17066338 | US | |
| Parent | PCT/US2016/066179 | Dec 2016 | US |
| Child | 16004099 | US |
