SYSTEM FOR CHANGING AN ANGLE OF A SUBJECT'S BONE

专利摘要:
system for changing an angle of a subject's bone. in accordance with some embodiments, systems and methods for altering an angle of a tibia of a subject having arthritis are provided. a system for changing an angle of a tibia of a subject with knee osteoarthritis includes: a non-invasively adjustable implant comprising an adjustable actuator configured to be placed within a longitudinal cavity, within the tibia, and having an outer shell and an inner shaft, telescopically disposed in the outer shell, the outer housing configured to engage a first portion of the tibia, and the inner shaft configured to engage a second portion of the tibia, the second portion of the tibia at least partially separated from the starting from the first portion of the tibia through an osteotomy; and a drive element comprising a permanent magnet and configured to be remotely operable to telescopically move the inner axis with respect to the outer casing.
公开号:BR112015009446B1
申请号:R112015009446-5
申请日:2013-10-28
公开日:2021-07-20
发明作者:David Skinlo；Thomas B. Buford；Ephraim Akyuz；Thomas Weisel；Roger Pisarnwongs；Adam G. Beckett；Jeffrey Lee Gilbert；Frank Yan Liu；Urs Weber；Edmund J. Roschak；Blair Walker；Scott Pool
申请人:Nuvasive Specialized Orthopedics, Inc.；
IPC主号:

专利说明:

Field of Invention
[0001] The field of the invention relates generally to medical devices for the treatment of osteoarthritis of the knee. Background of the Invention
[0002] Osteoarthritis of the knee is a degenerative disease of the knee joint that affects a large number of patients, mainly over the age of 40. The prevalence of this disease has increased significantly over the past decades, attributed partially, but not completely, the growing aging of the population, as well as the increase in obesity. The increase may also be due to the increase of highly active people within the population. Knee osteoarthritis is primarily caused by long-term stress on the knee that degrades the cartilage that covers the articular surfaces of bones in the knee joint. Often the problem becomes worse after a special event, trauma, but it can also be a hereditary process. Symptoms include pain, stiffness, reduced range of motion, swelling, deformation, muscle weakness, and several others. Osteoarthritis can include one or more of the three compartments of the knee: the medial compartment of the tibiofemoral joint, the lateral compartment of the tibiofemoral joint, and the patellofemoral joint. In severe cases, partial or total knee replacement is performed in order to replace the diseased portions with new weight bearing surfaces for the knee, usually made of implant grade plastic materials or metals. These operations involve significant postoperative pain and require substantial physical therapy. The recovery period can last weeks or months. There are several possible complications of surgery, including deep vein thrombosis, loss of movement, infection, and bone fracture. After recovery, surgical patients who have received uni-compartment or total knee replacement should significantly reduce their activity, removing high energy functioning and sports completely from their lifestyle.
[0003] For these reasons, surgeons are trying to intervene early, in order to delay, or even prevent, knee replacement surgery. Osteotomy surgeries can be performed on the femur or tibia in order to change the angle between the femur and the tibia, and thus adjust the stresses on different parts of the knee joint. In closed slice or closed slice osteotomy, a bone angle slice is removed, and the remaining surfaces are fused together, creating a new improved bone angle. In open slice osteotomy a cut is made in the bone and the cut slices are opened, creating a new angle. Bone graft is often used to fill the space again in an open slice shape, and often, a plate is attached to the bone with bone screws. Obtaining a correct angle during any of these types of osteotomy is almost always less than ideal, and even if the result is close to what was desired, there may be a subsequent loss of angle of correction. Some other complications experienced with this technique include non-union and material failure. SUMMARY OF THE INVENTION
[0004] In a first embodiment of the invention, a system for modifying an angle of a bone of a subject includes an adjustable actuator having an outer shell and an inner axis, telescopically disposed in the outer shell, a magnetic assembly configured to adjust the length of the adjustable actuator during axial movement of the inner shaft and outer casing relative to each other, a first support configured for coupling with the outer casing, and a second support piece configured for coupling with the inner shaft, in which the application of a field magnetic moving externally to the subject moving the magnetic field assembly such that the inner axis and outer casing move relative to each other.
[0005] In another embodiment of the invention, a system for modifying an angle of a bone of a subject includes a magnetic assembly, which has a polarized magnet radially coupled to an axis that has external threads, and a block that has internal threads and coupled to the shaft, wherein the rotational motion of the radially polarized magnet causes the shaft to rotate and move axially relative to the block. The system further includes an upper bone interface and a lower bone interface having an adjustable distance, where axial movement of the shaft in a first direction causes the distance to increase.
[0006] In another embodiment of the invention, a system for modifying an angle of a bone of a subject includes a mounting scissors having a first and second scissor arms rotatably coupled through a hinge, the first and second scissor arms coupled, respectively, the upper and lower bone interfaces configured to move relative to each other. The system further includes a hollow magnetic assembly containing an axially movable threaded spindle disposed therein, wherein the hollow magnetic assembly is configured to rotate in response to a moving magnetic field and wherein said translations of rotation into axial movement of the screw. advance. The system further includes a ratchet assembly coupled to one end of the threaded spindle and at the other end to one of the first and second scissors arms, the ratchet assembly comprising a pawl configured to engage teeth disposed at one of the upper and lower bone interfaces , and where the axial movement of the lead screw advances the pawl along the teeth and moves the upper and lower bone interfaces away from each other.
[0007] In another embodiment of the invention, a method of preparing a tibia for implantation of a displacement implant includes making a first incision in the skin of a patient at a location adjacent to the tibial plateau of the patient's tibia, creating a first tibial cavity by removing bone material along a first axis extending in a substantially longitudinal direction from a first point on the tibial plateau to a second point, placing an excavation device within the first cavity , the excavation device including an elongated main body configured to excavate the tibia asymmetrically with respect to the first axis, creating a second cavity in the tibia with the excavating device, wherein the second cavity communicates with the first cavity and extends substantially to one side of the tibia, and removing the digging device.
[0008] In another embodiment of the invention, a method of implanting a non-invasively adjustable system to change an angle of a patient's tibia includes creating an osteotomy between a first portion and a second portion of the tibia, making a first incision in a patient's skin at a location on the tibial plateau of the adjacent patient's tibia, creating a first cavity, in the tibia, along a first axis extending in a substantially longitudinal direction from a first point on the tibial plateau to a second point, placing an excavation device within the first cavity, the excavating device configured to excavate the tibia asymmetrically with respect to the first axis, creating a second cavity in the tibia with the excavating device, wherein the second cavity extends substantially to one side of the tibia, placing a non-invasively adjustable implant through the first cavity and, at least partially into the second cavity, the non-invasively adjustable implant comprising an adjustable actuator having an outer casing and an inner shaft, telescopically disposed in the outer casing, coupling the outer casing to the first portion of the tibia, and coupling the inner shaft to the second portion of the tibia. In some embodiments, the implant can also be modified invasively, such as minimally invasive.
[0009] In another embodiment of the invention, a method of preparing a bone for implantation of an implant includes making a first incision in the skin of a patient, creating a first cavity in the bone by removing bone material along from a first axis extending in a substantially longitudinal direction from a first point on the tibial plateau to a second point, placing an excavating device within the first cavity, the excavating device including an elongated main body shaped to excavate bone asymmetrically with respect to the first axis, the excavating device further comprising an articulated arm having a first end and a second end, the arm including a compaction surface, creating a second cavity in the bone, with the device of excavation, wherein the second cavity communicates with the first cavity and extends substantially to one side of the bone, and the oar. digging device.
[0010] In another embodiment of the invention, a method of preparing a bone for implantation of an implant includes making a first incision in the skin of a patient, creating a first cavity in the bone by removing bone material along from a first axis extending in a substantially longitudinal direction from a first point on the tibial plateau to a second point, placing an excavating device within the first cavity, the excavating device including an elongated main body. configured to excavate bone asymmetrically with respect to the first axis, the excavation device further comprising an articulated arm having a first end and a second end, the arm including an abrasive surface, creating a second cavity in the bone, with the excavation device, wherein the second cavity communicates with the first cavity and extends substantially to one side of the bone, and the removal of the digging device.
[0011] In another embodiment of the invention, a method of preparing a bone for implantation of an implant includes making a first incision in the skin of a patient, creating a first cavity in the bone by removing bone material along from a first axis extending in a substantially longitudinal direction from a first point on the tibial plateau to a second point, placing an excavating device within the first cavity, the excavating device including an elongated main body. configured to excavate the bone asymmetrically with respect to the first axis, the excavating device further comprising a rotary cutting tool configured to be moved substantially toward one side of the bone while the rotary cutting tool is being rotated, the creating a second cavity in the bone with the excavation device, wherein the second cavity communicates with the first cavity and extends substantially to one side of the bone, and removal of the excavation device.
[0012] In another embodiment of the invention, a system for modifying an angle of a patient's bone includes a non-invasively adjustable implant comprising an adjustable actuator having an outer casing and an inner shaft, telescopically disposed in the outer casing, the outer housing configured to engage a first bone portion, and the inner shaft configured to engage a second bone portion, a drive element configured to move the inner shaft relative to the outer shell, and an excavating device including a body main elongate configured to insert into a first cavity of bone along a first axis, the excavating device configured to excavate bone asymmetrically with respect to the first axis to create a second cavity communicating with the first cavity, wherein the actuator is configured adjustable to be coupled to the bone at least partially within the second. in the cavity.
[0013] In another embodiment of the invention, a method for changing a bone angle includes creating an osteotomy between a first portion and a second portion of a patient's tibia; creating a cavity in the tibia, withdrawing bone material along an axis extending in a substantially longitudinal direction from a first point on the tibial plateau to a second point; the placement of a non-invasively adjustable implant into the cavity, the non-invasively adjustable implant comprising an adjustable actuator having an outer shell and inner shaft, telescopically disposed in the outer shell, and a drive element configured to be remotely operable to telescopically shift the inner axis with respect to the outer casing; coupling one of the outer or inner casing of the shaft to the first portion of the tibia; coupling the other of the outer casing or inner shaft to the second portion of the tibia; and remotely operating the drive element to telescopically shift the inner shaft with respect to the outer shell, thereby changing an angle between the first portion and the second portion of the tibia.
[0014] In another embodiment of the invention, a system for modifying an angle of a tibia of a subject with osteoarthritis of the knee includes a non-invasively adjustable implant comprising an adjustable actuator configured to be placed within a longitudinal cavity, in the interior of the tibia, and having an outer casing and an inner shaft, telescopically disposed in the outer casing, the outer housing configured to engage a first portion of the tibia, and the interior shaft configured to engage a second portion of the tibia, the second portion of tibia separated at least partially from the first portion of the tibia by an osteotomy; and a drive element comprising a permanent magnet and configured to be remotely operable to telescopically move the inner axis with respect to the outer shell.
[0015] In another embodiment of the invention, a system for modifying an angle of a patient's bone includes a non-invasively adjustable implant comprising an adjustable actuator having an outer casing and an inner shaft, telescopically disposed in the outer casing, the outer casing associated with a first anchor hole, and the inner shaft associated with a second anchor hole, the first anchor hole configured to transmit a first fastener for adjustable actuator coupling of a first bone portion and the second anchor hole configured to pass a second fastener for coupling the adjustable actuator with a second bone portion, the second bone portion separated, at least partially, from the first bone portion by osteotomy; a drive element configured to be remotely operable to telescopically shift the inner axis relative to the outer shell; and wherein the non-invasively adjustable implant is configured to be angularly unrestricted with respect to at least one of the first bone portion, or the second bone portion when coupled to both the first and second bone portion. BRIEF DESCRIPTION OF THE DRAWINGS
[0016] FIG. 1 illustrates the desired alignment of a knee joint with respect to a femur and tibia.
[0017] FIG. 2 illustrates a knee joint with misalignment and associated medial compartment osteoarthritis.
[0018] FIG. 3 illustrates an opening slice technique on a tibia.
[0019] FIG. 4 illustrates an opening slice technique, with bone graft and an attached plate.
[0020] FIG. 5 illustrates a non-invasively adjustable slice osteotomy device placed in a tibia in accordance with a first embodiment of the present invention placed in a tibia.
[0021] FIG. 6 illustrates a view of the non-invasively adjustable slice osteotomy device of FIG. 5.
[0022] FIG. 7 illustrates a detailed view of the lower clip of the non-invasively adjustable slice osteotomy device of FIGS. 5 and 6.
[0023] FIG. 8 illustrates an embodiment of a magnetically adjustable implant.
[0024] FIG. 9 illustrates a non-invasively adjustable slice osteotomy device based on a spring element in accordance with a second embodiment of the present invention.
[0025] FIG. 10 illustrates a non-invasively adjustable slice osteotomy device based on an attached lift in accordance with a third embodiment of the present invention.
[0026] FIG. 11 illustrates the non-invasively adjustable slice osteotomy device of FIG. 9 to be inserted into a slice opening in a tibia.
[0027] FIG. 12 illustrates a non-invasively adjustable slice osteotomy device based on a scissors socket in accordance with a fourth embodiment of the present invention.
[0028] FIG. 13 illustrates the non-invasively adjustable slice osteotomy device of FIG. 12 with the upper bone interface removed to show the cut-off mechanism.
[0029] FIG. 14 illustrates a cross-sectional view of the non-invasively adjustable slice osteotomy device of FIGS. 12 and 13.
[0030] FIG. 15 illustrates a perspective view of an external adjustment device.
[0031] FIG. 16 illustrates an exploded view of a magnetic handpiece of the external adjustment device of FIG. 15.
[0032] FIG. 17 illustrates a non-invasively adjustable slice osteotomy device in accordance with a fifth embodiment of the present invention.
[0033] FIG. 18 illustrates a cross-sectional view of the non-invasively adjustable slice osteotomy device of FIG. 17.
[0034] FIG. 19 illustrates an exploded view of the non-invasively adjustable slice osteotomy device of FIG. 17.
[0035] Figs. 20-27 illustrate a method of implanting and operating a non-invasive adjustable slice osteotomy device for maintaining or adjusting a slice angle of an osteotomy opening a patient's tibia.
[0036] FIG. 28 illustrates axes of distraction in a tibia.
[0037] Figs. 29 to 31 illustrate a method of implanting and operating a non-invasive adjustable slice osteotomy device for maintaining or adjusting an angle of a sliced tibia osteotomy closure in a patient.
[0038] FIG. 32 illustrates a system for excavating bone material in accordance with a first embodiment of the present invention.
[0039] FIG. 33 illustrates a cutting tool rotation of the system of FIG. 32.
[0040] FIG. 34 illustrates a side view of the rotary cutting tool of FIG. 33.
[0041] FIG. 35 illustrates a cross-sectional view of the rotary cutting tool of FIG. 34, taken along line 35-35.
[0042] FIG. 36 illustrates a drive unit of the system of FIG. 32 with coating removed.
[0043] FIG. 37 illustrates the system of FIG. 32 in place inside a tibia.
[0044] FIG. 38 illustrates the system of FIG. 32 after removal of bone material from the tibia.
[0045] FIG. 39 illustrates a system for excavating bone material in accordance with a second embodiment of the present invention in position within the tibia.
[0046] FIG. 40 illustrates the system of FIG. 39 in an expanded configuration inside the tibia.
[0047] FIG. 41 illustrates an end view of an arm with an abrasive surface as part of an excavating device of the system of FIG. 39.
[0048] FIG. 42 illustrates a system for excavating bone material in accordance with a third embodiment of the present invention in position within the tibia.
[0049] FIG. 43 illustrates the system of FIG. 42 in an expanded configuration inside the tibia.
[0050] FIG. 44 illustrates an end view of an arm with a compaction surface as part of an excavating device of the system of FIG. 42.
[0051] FIG. 45A illustrates a non-invasively adjustable slice osteotomy device in accordance with a sixth embodiment of the present invention.
[0052] FIG. 45B illustrates the non-invasively adjustable slice osteotomy device of FIG. 45 A in a perspective view.
[0053] FIG. 46 illustrates a detailed view of the non-invasively adjustable slice osteotomy device of FIG. 45B taken from inside circle 46.
[0054] FIG. 47 illustrates the non-invasively adjustable slice osteotomy device of FIG. 45A in a distraction first position.
[0055] FIG. 48 illustrates the non-invasively adjustable slice osteotomy device of FIG. 45A in a second distraction position.
[0056] FIG. 49 illustrates a cross-sectional view of the non-invasively adjustable slice osteotomy device of FIG. 45 A in a distraction first position.
[0057] FIG. 50 illustrates a cross-sectional view of the non-invasively adjustable slice osteotomy device of FIG. 45 A in a second distraction position.
[0058] FIG. 51 illustrates a bushing of the non-invasively adjustable slice osteotomy device of FIG. 45 A.
[0059] Figs. 52-55 illustrate a method of implanting and operating the non-invasively adjustable slice osteotomy device of FIG. 45A for maintaining or adjusting an angle of a patient's tibial open-slice osteotomy.
[0060] Figs. 56A-56D illustrate bone screw configurations for the non-invasively adjustable slice osteotomy device of FIG. 45A.
[0061] FIG. Fig. 57 shows a non-invasively adjustable slice osteotomy device in accordance with a seventh embodiment of the present invention.
[0062] FIG. 58 illustrates a bone anchor for use with the non-invasively adjustable slice osteotomy device of FIG. 57.
[0063] Figs. 59-61 illustrate a method of implanting and operating the device in the non-invasively adjustable slice osteotomy of FIG. 57 for maintaining or adjusting a slice angle of an osteotomy opening a patient's tibia.
[0064] FIG. 62 illustrates a non-invasively adjustable slice osteotomy device in accordance with an eighth embodiment of the present invention in a first distraction position.
[0065] FIG. 63 illustrates the non-invasively adjustable slice osteotomy device of FIG. 62 in a second distraction position.
[0066] FIG. 64A illustrates an adjustable magnetic actuator of a non-invasively adjustable slice osteotomy device according to one embodiment of the present invention during removal of a magnetic assembly.
[0067] FIG. 64B illustrates the magnetically adjustable actuator of FIG. 64A after removing a magnet assembly.
[0068] FIG. 64C illustrates the magnetically adjustable actuator FIG of FIG. 64A after replacing an actuator housing cover.
[0069] FIG. 65A illustrates an adjustable magnetic actuator of a non-invasively adjustable slice osteotomy device in accordance with one embodiment of the present invention, prior to removal of a radially polarized permanent magnet.
[0070] FIG. 65B illustrates the magnetically adjustable actuator of FIG. 65A during removal of the radially-polarized permanent magnet.
[0071] FIG. 65C illustrates the magnetically adjustable actuator of FIG. 64 A, after removal of the radially polarized permanent magnet and replacement of a magnetic housing cover.
[0072] FIG. 65D illustrates the magnetically adjustable actuator of FIG. 64 A, after replacing an actuator housing cover.
[0073] Figs. 66-69 schematically illustrate various embodiments of alternative sources of a drive element of a non-invasively adjustable slice osteotomy device. DETAILED DESCRIPTION OF ILLUSTRATED ACHIEVEMENTS
[0074] FIG. 1 illustrates a standard alignment of a femur 100, and a tibia 102, a knee joint 104, where the hip joint (at the head femur 108), a knee joint 104, and an ankle joint (at the midline of the distal tibia 110) are oriented along a single line 112. Fibula 106 is shown alongside tibia 102. The knee joint 104 of FIG. 2 is shown in an arthritic state, in which a medial compartment 114 has been compromised, causing line 112 to pass medially outside the center of the knee joint 104.
[0075] FIG. 3 illustrates an open slice osteotomy 118 formed by cutting along a cut line 120, and an open slice angle of FIG. 4 illustrates the final configuration of this open slice by placing bone graft material within the osteotomy opening 122 in slice 118, and then placing a plate 124, which is then secured to the tibia 102 with tibial screws 126.
[0076] FIG. 5 illustrates a tibia 102 with a non-invasive adjustable slice osteotomy device 128 implanted. The non-invasively adjustable slice osteotomy device 128 is shown without the tibia 102 in FIG. 6. The non-invasively adjustable slice osteotomy device 128 includes an actuator 142 comprising an outer casing 130 and an inner rod 132 telescopically coupled within the outer casing 130 for non-invasive longitudinal adjustment. To implant the non-invasively adjustable slice osteotomy device 128, a hole 138 is drilled into the tibia 102, and then a cut is made along the cut line 120. The actuator 142 is then inserted, the distal end 140 first, into hole 138. A slice opening 144 is open enough to be able to insert a lower support member 136 and an upper support 134. The lower support 136, as seen in FIG. 7 has an opening 146 and an inside diameter 148 which enable it to be fitted over a circumferential groove 150 around the outer housing 130. The lower bracket 136 is then secured to the tibia 102 in the lower portion 152 of the opening 144 by slicing placement. bone screws (not shown) through holes 154. top bracket 134 is then dropped into place and secured to a proximal end 156 of actuator 142 by tightening a clamp screw 158 that aligns through a threaded hole in inner shaft 132 of actuator 142. Top bracket 134 is then secured to tibia 102 at top portion 162 of slice opening 144 by placing bone screws (not shown) through holes 164.
[0077] FIG. 8 illustrates an adjustable magnetic actuator 142 that can be used in the embodiments of Figs. 5-7, or other embodiments described herein. An inner shaft 132, having an end 160, is telescopically adjustable within an outer housing 130 through the use of a magnetic assembly 166 contained therein. Magnet assembly 166 comprises a radially polarized, cylindrical magnet 168 that engages with one or more planetary gear stages 170. The planetary gear stages output 170 to a lead screw 172. In some embodiments, the final gear stage 170 may be secured to lead screw 172 with a high strength stud, eg a stud constructed from 400 series stainless steel. Inner shaft 132 contains a cavity 174 to which a nut 176 is attached which has a female thread which interacts with the male thread of lead screw 172. A radial bearing 178 and thrust bearing 180 allow the magnet assembly 166 to operate with relatively low friction. A seal ring 182 is held within a circumferential groove within the outer shell wall 130, and the inner diameter of the seal ring 182 dynamically seals the outer diameter of the inner shaft 132.
[0078] Returning to FIG. 5, the non-invasively adjustable slice osteotomy device 128 is used to gradually open slice opening 144 over time. By applying a moving magnetic field from a location relative external to the patient, for example, after the patient has recovered from surgery, actuator 142 of FIG. 6 can be gradually increased (eg about one (1) mm per day), allowing the opening of slice 144 to reach the desired angle, which can be tested by having the patient perform different motion studies (stepping, turning , etc.) until the most comfortable condition is reached. Gradual elongation may allow for the possibility of Ilizarov osteogenesis, in which new bone material forms in the slice opening as it is opened. In this mode, a bone graft may be unnecessary. After the desired slice opening angle 144 is reached, the newly grown bone material can be allowed to consolidate. If, during the process, the elongation has been too fast, or new bone has not been sufficiently consolidated, a moving magnetic field can be applied in an opposite direction thereby shortening the actuator 142 to increase compression and create a good dimension for the formation. of corns. After confirming that sufficient callus formation has occurred, stretching can be resumed at the same speed, or at a different speed. Once the elongation is sufficiently complete, and bone consolidated is stable, it may be desirable to remove the entire non-invasive adjustable slice osteotomy device 128, or simply the magnetic assembly 166.
[0079] FIG. 9 illustrates a non-invasively adjustable slice osteotomy device 184 in magnetic assembly comprising a magnet 192, including, for example, a radially polarized cylindrical magnet 186, which is coupled to a drive screw 188. As a radially polarized cylindrical magnet 186 is connected by an externally applied moving magnetic field, drive screw 188 rotates within a block 190 having a female thread, causing drive screw 188 and magnet 192 assembly to be moved in an axial direction first. place (A). As the magnetic assembly 192 moves axially it pushes a curved shaped memory (eg Nitinol® super elastic) spring plate 194 at the connection point 196. A thrust bearing 198 at the connection point 196 allows for rotation continuous cylindrical magnet 186 as polarized force increases. As an inner curve 200 of plate spring 194 is pressed from Nitinol in the first axial direction (A), the width (W) of plate spring 194 increases Nitinol. A cutout 202 in the spring plate Nitinol 194 provides space for the radially polarized cylindrical magnet 186 to turn on and to move in the first axial direction (A).
[0080] FIG. 10 illustrates a non-invasively adjustable slice osteotomy device 216 similar to the non-invasively adjustable slice osteotomy device 184 of FIG. 9, except that the nitinol plate spring 194 of FIG. 9 is replaced by a connecting elevator 204. The elevator 204 comprises a lower plate 206 and an upper plate 208, which are connected to a block 190 by means of pins 210, which allow each plate 206 and 208 to increase the angulation to the along the arrows (B). Plates 206 and 208 are connected to inner plates 212 and 214 by means of pins 210. The hinged structure of inner plates 212, 214 is pushed forward in a similar manner as the Nitinol spring plate 194 is pushed in the axial direction first (A) in fig. 9.
[0081] FIG. 11 illustrates a non-invasively adjustable slice osteomy device 184 being placed in a slice opening 144 in a tibia 102. The non-invasively adjustable slice osteomy device 216 of FIG. 10 can be entered in the same way.
Figs. 12-14 illustrate a non-invasively adjustable slice osteomy device 218 based on hand scissors. The non-invasively adjustable slice osteomy device 218 comprises a main shell 220 having a lower bone interface 222 and an upper bone interface 224, the upper bone interface 224 adjustable with respect to the main shell 220 and the lower bone of interface 222. FIG. 13 shows a non-invasively adjustable slice osteomy device 218 with the upper bone interface 224 removed to better appreciate the internal components. A scissors assembly 225 comprises a first scissors 226 and a second scissors 228, which can be coupled by means of a central pin 230 in a hinged manner. Distal arms 234 and 238 226 and 228 can be coupled to the distal ends of the lower bone interface 222 and upper bone interface 224 by an arm 240. The pins 232 of the second scissors 228 are coupled to an interconnect 242 of a magnetic field assembly 244 with a pin 240. A hollow magnet assembly 246 has internal threads 247 that engage external threads 249 of a lead screw 248 that is connected to interconnect 242. The hollow magnet assembly 246 may comprise a hollow radially biased magnet. Interlock 242 includes a pawl 251, which is capable of engaging teeth 253 of a ratchet plate 255. As applied externally in motion causes the magnetic field of magnet 246 to rotate, lead screw 248 and interlock 242 are moved in a first axial direction (A), causing the assembly 225 to open scissors, and thus increase the distance (D) between the lower bone interface 222 and the upper bone interface 224. An arm 236 of the first scissors 226 is capable of sliding into a channel 257 at the interface of the upper bone 224. The pawl 251 and teeth 253 of the ratchet plate 255 form a one-way ratchet, allowing the distance (D) to be increased , but not decreased.
[0083] FIG. 15 illustrates an external adjustment device 1180 that is used to non-invasively adjust the devices and systems described herein. The external adjustment device 1180 comprises a magnetic hand piece 1178, a control box 1176 and a power supply 1174. The box control 1176 includes a control panel of a 182 with one or more controls (buttons, switches and touch, motion, audio, or light sensors) and a monitor 1 184. The display 1184 can be visual, auditory, tactile, etc., or a combination of the aforementioned features. The external adjustment device 1180 may contain software that allows for programming by the clinician.
[0084] FIG. 16 shows in better detail the handpiece 1178 of the external adjustment device 1180. As seen in FIG. 16, there are a plurality of, for example two (2), magnets 1186 having a cylindrical shape (also, other shapes are possible). The 1186 magnets can be made from rare earth magnets, and can in some embodiments be radially polarized. Magnets 1186 are bonded or unsecured within magnetic cups 1187. Magnetic cups 1187 include a shaft 1198, which is connected to a first magnet gear 1212 and a second magnet gear 1214, respectively. The orientation of the poles of each of the two magnets 186 are maintained relative to each other by means of the shifting system (by use of center gear 1210, which meshes with the first sprocket both magnet 1212 and second gear magnet 1214). In one embodiment, the north pole of one of the magnets 1186 rotates synchronously with the south pole of the other magnet 1186 at corresponding watch positions throughout one full rotation. The configuration has been known to provide improved torque delivery, for example, cylindrical magnet 168 or 246. Examples of methods and embodiments of external adjustment devices that can be used to adjust non-invasively shape adjustable slice, osteotomy device 218, or other embodiments of the present invention are described in U.S. Patent No. US 8,382,756, the disclosure of which is incorporated herein by reference in its entirety, and in Serial Patent Application No. US 13/172,598 which was published under the number of publication US 2012/0004494 A1, the disclosure of which is incorporated herein by reference in its entirety.
[0085] The components of the magnetic hand piece 1178 are held together between the magnet plate 1 190 and a face plate 1 192. Most of the components are protected by a cover 1216. The magnets 1 186 rotate within a static magnet cover 188, so that the magnetic handpiece 1178 can be placed directly on the patient while not transmitting any movement to the external surfaces of the patient. Prior to distracting intramedullary elongation device 1110, the operator places the magnetic handpiece 1178 through the patient near the location of the cylindrical magnet 1134. A magnet insulator holder 194 that is interposed between the two magnets 1186 contains a viewing window 1196, to assist with placement. For example, a mark made on the patient's skin at the appropriate location with an indelible marker can be seen through the viewing window 1196. To perform a distraction, the operator holds the magnetic handpiece 1178 by its 1200 handles and depresses a switch distral 1228, making the 1202 engine steer in a first direction. Motor 1202 has a gearbox 1206 which causes the rotation speed of an output gear 1204 to be different from the rotation speed of motor 1202 (eg a slower speed). Output gear 1204 then turns a 1208 reduction gear which meshes with the 1210 center gear, causing it to rotate at a different rotational speed than the 1208 reduction gear. The 1210 center gear meshes as much. with the 1st magnet gear 1212 and the 2nd magnet gear 1214 transforming them at a rate that is identical to another. Depending on the part of the body where the magnets 1186 of the external adjustment device 1180 are located, it is desired that this rate be controlled, to minimize the density of the resulting induced current transmitted by the cylindrical magnet 1 186 and 1 134 though tissue and fluid of the body. For example, a magnet rotation speed of 60 RPM or less is contemplated although other speeds may be used, such as 35 RPM or less. At any time, distraction can be reduced by pressing the retraction switch 1230, which may be desirable if the patient experiences pain, or numbness in the area holding the device.
[0086] Figs. 17-19 illustrate a non-invasively adjustable slice osteomy device 300 comprising an adjustable magnetic actuator 342 having a first end 326 and a second end 328. An inner shaft 332 having a cavity 374 is telescopically coupled within a housing exterior 330, which comprises a distraction structure 312 and a gearbox 306. At least one transverse hole 305 passes through an end cap 302 located at the first end 326 of the magnetically adjustable actuator 342. The end cap 302 is attachable sealingly to the gearbox 306 by a circumferential solder joint 390. A second solder joint 392 sealingly protects the distractor housing 312 in the gearbox 306. One or more transverse holes 364 pass through the inner shaft 332 The one or more transverse holes 364 and the at least one transverse hole 305 allow passage of at least one foot. locking bolt. Some embodiments use only one transverse hole 364 and one transverse hole 305, so as to better allow rotational play between the magnetically adjustable actuator 342 and the clamping screws as the magnetically adjustable actuator 342 is adjusted. One or more longitudinal grooves 372 on the outer surface of inner shaft 332 codedly engage with lugs 375 in an anti-rotation ring 373 which engages within recesses of the end of housing 312 distractingly to a flat edge 384 of anti-rotation ring 373. One or more fin guides 383 in anti-rotation ring 373 can keep anti-rotation ring 373 rotationally static within cuts of 391 in distraction structure 312.
[0087] The contents of the magnetically adjustable actuator 342 are protected from bodily fluids by one or more O-rings 334 residing within circumferential grooves 382 on the inner shaft 332, the dynamic seal along the inner surface of the housing 312. The interior of the shaft Distractor 332 is driven axially with respect to outer housing 330 by a lead screw 348 which is connected by a radially polarized cylindrical magnet 368. The radially polarized cylindrical magnet 368 is connected within a first magnet housing 308 and a second housing 310 and the magnet is rotatably held on a pin 336 at one end by a radial bearing 378, which directly engages the recess 304 of the cover 302. The second magnet housing 310 outputs a first stage 367 of three-stage planetary gears 370. planetary gears 387 of the three-phase planetary gear 370 in turn inside inner teeth 321 inside the gearbox. gears 306. First stage 367 exits to second stage 369, and second stage 369 exits to third stage 371. Third stage 371 is coupled to threaded spindle 348 by a locking pin 385, which passes through holes 352 at both third stage outputs 371 and lead screw 348. A lead screw coupler 339 is also held to lead screw 348 of pin 385, which passes through hole 359. Threaded lead screw 348 engages a nut 376 which is attached within cavity 374 of inner rod 332. Each planetary gear phase 370 incorporates a 4:1 gear ratio, producing a total gear ratio of 64:1, so 64 turns of the radially polarized cylindrical magnet 368 causes a single turn of lead screw 348. A thrust bearing 380, is loosely held in the axial direction between edges on gearbox 306. Lead screw engagement 339 includes a boss 355, which is similar to a lug. opposite edge (not shown) at the base of threaded spindle 348. If the inner shaft 332 is retracted to the minimum length, the edge at the base of lead screw 348 abuts shoulder 355 of the coupler lead screw, ensuring that the lead screw feed 348 cannot be pressed against the nut with too high a torque. Thrust bearing 380 is carried between an edge 393 in gearbox 306 and an insert 395 in the end of gearbox 306. Thrust bearing 380 serves to protect radially polarized cylindrical magnet 368, planetary gear stages 370, magnet housings 308 and 310, as well as the radial bearing 378 from damage due to compression. A holding member 346 comprising a thin arc of magnetic material, such as "400 series" stainless steel, is attached within gearbox 306, adjacent to radially polarized cylindrical magnet 368, and can attract a pole of radially polarized cylindrical magnet 368. in order to minimize the possibility of the radially polarized cylindrical magnet 368 turning when it is not being adjusted by the external adjustment device 1180, for example, during patient movement.
[0088] The non-invasively adjustable slice osteomy device 300 has the ability to increase or decrease its length by at least about three millimeters from each direction, in one embodiment, and about nine millimeters from each direction in another embodiment. The non-invasively adjustable slice osteomy device 300 can achieve a distraction force of 240 kilos when the magnetic handpiece 1178 of the external adjustment device 1180 is placed so that the magnets 1186 are about half an inch from the cylindrical magnet. radially polarized 368. Most components of the non-invasively adjustable slice osteomy device can be made from titanium or titanium alloys such as titanium-6A1-4V, chromium, cobalt, stainless steel, or other alloys. When implanted, the non-invasively adjustable slice osteomy device 300 can be inserted manually or can be attached to an insertion tool (e.g., a piercing guide). An interface 366 comprising an internal thread 397 is located on the end cap 302 for reversible engagement with the male threads of an insertion tool. Alternatively, these features may be located over end 360 of inner rod 332. In addition, a detachable tie rod may be attached to either end of the non-invasively adjustable slice osteomy device 300 so that they can be easily removed, if placed incorrectly.
[0089] Figs. 20-27 illustrate a method of implanting and operating a non-invasively adjustable slice osteomy device 125 to alter an angle of a patient's tibia. In FIG. 20, a front view of the right knee joint 104 of a patient with osteoarthritis of the knee is shown, including the femur 100, tibia 102, and fibula 106. The non-invasively adjustable slice osteomy device 125 can be placed to the side. of the medial tibia 102 (away from the fibula 106). The tibial bone 102 is thus prepared to allow a non-central placement of the non-invasively adjustable slice osteomy device. A skin incision is made with a medial side of the tibia 102 and an open slice osteotomy 118 is made relative to a pivot point 107, by creating a first cut 103, for example with an oscillating saw, and opening the osteotomy opening in slice1 18, as seen in FIG. 21. A typical location for pivot point 107 can be described by distances X and Y in FIG. 20. In some embodiments, X = 10 mm and Y = 15 mm. At the pivot point, it is common to drill a small drill hole and place an apex pin, for example a point pin with a diameter of about 3mm to about 4mm. The open-slice osteotomy 118 now separates a first part 119 and a second part 121 of the tibia 102.
[0090] As can be seen in FIG. 22, an incision is made in the skin, a drill 111 is placed in the center of the tibial plateau 101, and a first cavity 109 having a first axis 117 is drilled from the tibial plateau 101 into the tibial medullary canal 102. May be desired during this drilling step to place a temporary slice 123 into the osteotomy open slice 118 in order to maintain stability. A drill diameter of about 12 mm or less, or more preferably about 10 mm or less is used to create the first cavity 109. FIGS. 23 and 24 illustrate the steps for creating a generalized second cavity 15. Various embodiments are represented here by an excavating device 113 which is inserted into the first cavity 109 through the opening in the tibial plate 101. The second cavity 115 is then formed to one side of the first cavity 109, in this case the medial side. As shown in FIG. 25, after cupping device 113 has been removed, a non-invasively adjustable slice osteomy device 125 having an outer casing 129 and an inner shaft 127 is inserted into the first cavity 109. In FIG. 25, the non-invasively adjustable slice osteomy device 125 is shown with the inner shaft 127 facing upwards (upwards) over the patient, but may in certain cases for implantation of the shape adjustable slice osteomy device. non-invasive 125 with inner shaft 127 facing inferiorly (downwards). First transverse hole 135 and second transverse hole 137 in the non-invasively adjustable slice osteomy device 125 are configured for positioning bone anchors, e.g., fixation screws.
[0091] In fig. 26, the non-invasively adjustable slice osteomy device 125 is then placed within the second cavity 115 and secured with a first anchoring means 131 of the first transverse hole 135 and a second anchor 133 through the second transverse hole 137. in calculations made from pre-operative and/or surgical X-ray or other images, a slice angle (i is defined between the first portion 19 and a second portion 121 of the tibia. After post-surgical recovery, the patient can return for a dynamic imaging session (for example x-ray) during which the patient stands, and even moves the knee joint 104, in order to better confirm that slice angle i is allows for optimal conformation of the knee joint 104. If, for example, at this time, it is desired to increase the slice angle i, the magnetic handpiece 1178 of the external adjustment device 1180 of Fig. 15 is then placed over the patient's knee joint 104 andis operated so that the inner rod 127 is distracted from the outer casing 129, to increase to a greater slice angle 2 (FIG. 27). It may be desired for at least one of the anchors (eg second anchor 133) to have sufficient clearance in the transverse hole (eg second transverse hole 137) so that any angling that occurs while the osteomy device 125 Non-invasively Adjustable Slice Osteomy Device is distracted, will not put an additional flexion moment on the 125 Non-invasively Adjustable Slice Osteomy Device. The dynamic imaging session can be done at a time after surgery when the swelling has decreased, but before bone consolidation is significant. This period can be approximately one to two weeks after surgery. If an adjustment (increase or decrease) is performed, an additional dynamic imaging session can be performed, for example, a week later. The non-invasively adjustable slice osteomy device 125 is provided so that it can be lengthened or shortened or, in other words, so that the open slice osteomy angle 118 can be further increased or decreased, depending on the determination of the desired correction.
[0092] An alternative way of quantifying the amount of opening of the osteotomy opening slice 1 18 is to measure, for example, through radiographs, the gap G1, G2 at the medial edge 181 of the open slice osteomy 118. In the typical range of the open-slice osteomy angle 118, and the typical 102 tibia size range of patients, the G1, G2 difference in millimeters tends to approximate the slice angle (X1, 2 in degrees. For example, G1 (mm) ~ 1 (°); G2 (mm) ~ 2 (°). It is expected that, assuming correction is necessary, productive stretching will be done at a rate in the range of about 2 mm interval (G) increase per day, or less gap increase rate (GIR) can be defined as the change in gap in millimeters per day. One consideration in determining the rate of gap increase (GIR) to use is the patient's pain tolerance. greater pain, for example, the pain caused by stretching the soft tissue, and thus a rate of increased internal upper range (GIR). Another consideration is the amount of bone growth that can occur. One method to assess the amount of bone growth is through radiography. The preferred gap rate increase (GIR) is one in which bone growth is occurring within the open slice osteotomy 118, but early bone consolidation is not occurring (consolidation that would "freeze" the mobility of the open slice osteotomy 118, making -o unable to be opened anymore). It may be desirable to purposefully deploy the adjustable slice osteotomy 125 device with an undersized initial clearance (G0) so that an optimal range (G1) can be gradually achieved through non-invasive adjustments. It is contemplated that, during the adjustment period, a total of one to twenty or more adjustment procedures may be performed, for a total amount of from about 1 mm to about 20 mm of gap increase (G), such as during an adjustment period of one month or less. Typically, the fitting period can extend for approximately ten days, involve around ten adjustment procedures and involve a total amount of around 5 mm to gap increase of around 12 mm.
[0093] By locating the non-invasively adjustable slice osteomy device 125 medially, in the tibia, rather than near the centerline, a larger moment can be placed over the first portion 119 and a second portion 121 to open the slice. opening 118 at osteotomy relative to pivot point 107. In addition, for a special distraction force applied by the non-invasively adjustable slice osteotomy device 125, a greater amount of distraction can be achieved. In FIG. 28, three different axes of distraction (A, B, C) are shown, which represent three possible positions of the shape of the non-invasively adjustable slice osteomy device 125. The axis of distraction A is approximately midline on the tibia 102, while distraction axis B is about 11° angular from the midline, and distraction axis C is about 22° angular from the midline. The length Dd from hinge point 107 to distraction axis B may be about 32% greater than the length Db from hinge point 107 relative to distraction axis A. More significantly, length Dc from hinge point 107 to distraction axis C may be approximately 60% greater than the length from pivot point 107 relative to distraction axis A. The distraction force of the non-invasively adjustable slice osteomy device 125 is required to overcome a series of resistances arranged along the tibia due to the binding effect of the soft tissue. Placement of the non-invasively adjustable slice osteomy device 125 along the C axis and therefore in the second cavity 115 (FIG. 27) may allow for more effective distraction of the open slice osteomy 118.
[0094] Figs. 29-31 illustrate a method of implanting and operating a non-invasively adjustable slice osteomy device 125 to alter an angle of a patient's tibia, but unlike the open slice osteomy 118 shown in FIGS. 20 to 27, a closed slice osteomy 141 is shown. In FIG. 29, the first cut 103 is made, but in FIG. 30 a second cut 105 is made and a slice of bone is removed. The second cut 105 purposely removes slightly more bone than necessary to optimize the correction angle, and as shown in FIG. 31, the closed-slice osteotomy 141 is left with a slight clearance, allowing it to be adjusted posteriorly in any direction (to increase or decrease the angle thereafter). The deployment method continues by following the remaining steps outlined in FIGS. 22 to 26, and the closed-slice osteomy angle 141 can be increased or decreased as described in FIG. 27.
[0095] Figs. 32-36 illustrate a first system for excavating bone material 400. The system for excavating bone material 400 is configured to create a second cavity 15 generally as described in FIGS. 22 to 24. A drive unit 404 is coupled to a rotary cutting tool 402 by means of a flexible drive train 408. The rotary cutting tool 402 is an embodiment of excavating device 113 as shown in FIG. 23, but may also serve as drill bit 111 of FIG. 22. The rotary cutting tool 402, as shown in FIGS. 32-35, extends between a first end 444 and second end 446 (as shown in FIG. 34.), and comprises a distal stent 412 that is coupled to a proximal stent 410. As shown in FIG. 35, distal stent 412 includes a small diameter portion 440 that inserts into proximal stent 410. A circumferential engagement member 434 is held axially between distal stent 412 and proximal stent 410, and includes a number of cutouts 435 (FIG. 34) arranged around its circumference, forming a pulley. Distal reamer 412, proximal reamer 410 and circumferential engagement member 434 are made together with pins 437, which are passed through holes 436, and which ensure that all components rotate in unison. A set screw 438 is secured within an inner surface female thread of the proximal reamer 410. The distal reamer 412 additionally includes a cone 442 and a blunt tip 414. The outer diameter of the rotary cutting tool 402 may be about 12 mm or less, and more specifically about 10 mm or less. The outer diameter of the proximal countersink 410 can be about 9 mm and the outside diameter of the distal countersink can taper from about 9 mm to about 6.35 mm at the blunt end 414. The drive unit 404, as best seen in Figs. 32 and 36 comprises a gearbox 416 covered by a pulley cover plate 418 and a unit cover plate 420. Several screws 421 secure the unit cover plate 420 to the gearbox 416, and four screws 426 secure the cover plate pulley 418 to drive box 416. Drive box 416 is not shown in FIG. 36 in order to show more detail of the internal components. In FIG. 32, a fastener 406 is coupled via screws 424 to a mounting plate identifier 422 which in turn is detachably attached to the drive box 416 (e.g., by means of screws or a tweezer).
[0096] A shaft 428 (Fig. 36) having a keyway 430, is configured for detachable coupling to an electric drill motor 468 (Figs. 37 and 38). A large pulley 450 is attached to shaft 428 with an adjustment screw 451 so that rotation of shaft 428 by electric drill unit 468 causes rotation of large pulley 450. Shaft 428 and large pulley 450 are held between two bearings ball bearing 448 (bottom of ball bearing not visible), and a shim washer 464 and wave washer 466 are located on both sides of the large pulley 450 in order to control the amount of axial play. A roller wheel 452 is rotatably connected to the end of a rolling wheel blade 456 with a pin 454. The roller 456 sledding wheel is capable of sliding axially within the drive housing 416 and cover plate unit 420 with the loosening of a thumbscrew 432 whose threaded shaft engages with internal threads 462 on the roller wheel slide 456. The roller declination wheel 456 can be secured by tightening the screw 432 so that it does not slip during use. Longitudinal slit 460 in sliding wheel roller 456 controls the total amount of axial slip, providing a first end 461 and a second end 463 abutting a stop 458.
[0097] Flexible drive train 408 comprises a small toothed belt, eg a Kevlar® width of about 3 mm or a fiberglass reinforced polyurethane belt having a slip torque greater than 10 inch-ounces when used with the large pulley 450 or the circumferential hitch member 434. A potential example of torque for skidding is 13 inch-ounce. The teeth of the flexible drive train can be located at a pitch of two millimeters. FIG. 37 shows drive unit 404 of bone material excavation system 400 coupled to electric drill motor 468. Electric drill motor 468 includes a motor housing 476, a handle 470, and a battery 472. The handle may include any number. of Interfaces known in the art for turning the electric drill apparatus 468 on or off, or controlling the speed. In some embodiments, the drill unit 468 may plug directly into a standard power source, rather than having the battery 472. The key end 430 of the shaft 428 is coupled to a coupler of the shaft 474 of the electric drill unit 468.
[0098] In fig. 37, the first cavity 109 having been created, the flexible drive train 408 is inserted through the medial incision and into the open slice osteotomy 118, between the first portion of 119 and the second portion 121 of the tibia. The rotary cutting tool 402 is then placed under the first cavity 109 of the tibia 102, so that the desired amount that the flexible drive train 408 turns around the circumferential engaging element 434 of the rotary cutting tool 402. the 432 thumb screw loosened from tension on the flexible train unit 408 is adjusted and then tighten the thumb 432 is tightened. At this desired tension, the teeth of flexible drive train 408 should mate well within cutouts 435 (Fig. 34) of circumferential engagement member 434 and roller 452 rotates should rotatably contact the outer surface of circumferential engagement member 434, its stabilization. The electric drill unit 468 is operated, causing the large pulley 450 of FIG. 36 to rotate flexible drive train 408, and thereby rotate rotation cutting tool 402 through engagement with circumferential engagement member 434 (FIG. 34). The large pulley 450 may be twice the diameter of the circumferential engagement member 434, thus causing the rotary cutting tool 402 to rotate at half the speed of the output of the electric drill unit 468. Other ratios are also within the scope of the present invention. It may be desirable to control the rotation speed of the rotary cutting tool 402 in order to minimize heating of the bone surrounding the bone being cut material, and thus limiting damage to the bone, which may impede normal growth during healing process. While rotary cutting tool 402 is rotated by drive unit 404, handle 406 is pulled causing rotary cutting tool 402 to cut a second cavity 115 following path 477 (FIG. 38). The proximal reamer 410 cuts into the first part 119 of the tibia 102 and the distal reamer 412 cuts into the second part 121 of the tibia 102. After the second cavity 115 is created, the screw 432 is loosened and tensioned on the flexible drive train 408 is at least partially reduced. The rotary cutting tool 402 is then removed and the flexible drive train 408 is pulled out of the open slice osteotomy 118. A line of rope can be connected to the rotary cutting tool 402, for example, through cap screw 438 , and to apply tension, thus facilitating removal. A swivel joint may further be included between the tie line and the rotary cutting tool 408 in order to keep the rope line from being twisted.
[0099] FIGS. 39 to 41 illustrate a second system for excavating bone material 500. The system for excavating bone material comprises an excavating device 502 having a hollow outer shaft 508. The hollow outer shaft 508 has a distal end 507 and an end proximal 509 and is connected to a manual outer shaft 510 which is configured to be held with one hand to stabilize or move the excavating device 502. An adjustment element 512 having a threaded end 516 is connected to an adjustment handle 514. Threaded end 516 threadingly engages internal threads (not shown) within hollow outer shaft 508, and rotating adjustment element 512 by manipulating adjustment lever 514 moves adjustment element 512 axially with respect to Outer hollow shaft 508. Outer hollow shaft 508 has a cut away section 151 adjacent to a pivotable arm 504. The threaded end 516 is coupled to the arm 504 by means of a link 520. Link 520 attaches to arm 504 at a first pivot point 518, and link 520 attaches to threaded end 516 of adjusting element 512 at a second pivot point 521 (as seen in fig. 40). Rotation of the adjustment knob 514 in a direction of rotation R, relative to the hollow outer shaft 508 and outer shaft 510, treats the causes of the adjustment member 512 to move in the direction D with respect to the hollow outer shaft 508, and causes causing the arm 504 to expand in path E relative to the hollow outer shaft 508.
[0100] The arm 504 comprises an abrasive surface 506 for removing bone material. As seen in FIG. 41, arm 504 may be an elongate member having a semi-cylindrical cross section, and abrasive surface 506 may comprise a scraper, covered with a plurality of sharp projections 513. FIG. 39 shows excavating device 502 placed within a first cavity 109 made within a tibia 102. In order to create a second cavity 115 to one side of the first cavity 109, the operator grips to manipulate the outer shaft 510 with one hand. and the adjustment handle 514 with the other hand, and begins to move the bone material excavation system 500 in a back and forth motion 522, while slowly turning the adjustment handle 514 in the direction of rotation R. bone material is removed, arm 504 is able to be expanded further along path E (FIG. 40), as adjustment handle 514 is connected in direction of rotation R and system for excavating bone material 500 is moved in a reciprocating motion 522. The culmination of this step is seen in FIG. 40, with the second cavity 115 created in the first portion of 119 and the second portion 121 of the tibia 102. At the end of this step, the adjustment handle is attached in a direction of rotation opposite to the direction of rotation R, thus allowing the arm to 504 to collapse, and the excavation device 502 to be removed from the tibia 102.
[0101] FIGS. 42-44 illustrate a third system for excavating bone material 600. The system for excavating bone material 600 comprises an excavating device 602 having a hollow outer shaft 608. The hollow outer shaft 608 has a distal end 607 and an end proximal 609 and is connected to a manual outer shaft 610 that is configured to be held with one hand to stabilize or move the excavation device 602. An adjustment element 612 having a threaded end 616 is connected to an adjustment handle 614. The threaded end 616 by threading fits the internal thread (not shown) within the hollow outer shaft 608, and rotating the adjustment element 612 by manipulating the adjustment lever 614 moves the adjustment element 612 axially with respect to the hollow outer shaft 608. The hollow outer shaft 608 has a distance cut section 611 adjacent to a pivotable arm 604. The threaded end 616 is coupled to the arm 604 by mei. that of a link 620. Link 620 connects to arm 604 at a first pivot point 618, and link 620 connects to threaded end 616 of adjusting element 612 of a second pivot point 621. of adjustment element 614 in a direction of rotation R, with respect to the hollow outer axis 608 and of the outer axis 610 treat the causes of the adjustment member 612 to move in direction D with respect to the hollow outer axis 608, and causes the arm 604 to expand in the path of E with respect to the hollow outer shaft 608, as seen in FIG. 43.
[0102] As can be seen in FIG. 44, arm 604 comprises a compaction surface 606 for compacting cancellous bone. Arm 604 may be an elongated member having a tubular or partially tubular cross-section, and compacting surface 606 may include a leading edge 690 for cutting a path through cancellous bone and a first sloping surface 692 that extends from leading edge 690. The first sloped surface 692 serves to compact cancellous bone, but also allows some cancellous bone to slide past as cancellous bone moves out of the way. Likewise, a second angled surface 694 at a different angle than the first angled surface 692 may be configured as part of the compaction surface 606. FIG. 42 shows the excavation device 602 placed within a first cavity 109 made within a tibia 102. In order to create a second cavity 115 to one side of the first cavity 109, the operator grips to manipulate the outer shaft 610 with one hand and the adjustment handle 614 with the other hand, and the adjustment handle 614 begins to slowly rotate in the direction of rotation R. The cancellous bone is compacted as the arm 604 is expanded further along the path E by connecting the adjustment handle 614 in the direction of rotation R. The culmination of this step is seen in FIG. 43, with the second cavity 115 created in the second portion 121 of the tibia 102. The digging device 602 can be moved over the tibia 102 and compaction can be completed within the first portion 119 of the tibia 102. Upon completion of the compaction step, the adjustment handle which is attached in a direction of rotation opposite to the direction of rotation R, thus allows the arm 604 to collapse, and the excavating device 602 to be removed from the tibia 102.
[0103] Figs. 45A to 50 illustrate a non-invasively adjustable slice osteotomy device 700. The non-invasively adjustable slice osteotomy device 700 has a first end 726 and a second end 728, as shown in FIG. 45A, and is similar in construction to the non-invasively shaped osteotomy adjustable slice device 300 of FIGS. 17-19. However, the first end 726 of the non-invasively adjustable slice osteomy device 700 comprises a Herzog curve 780, wherein the first end 726 projects the angle . In some embodiments, the angle can range from about 5° to about 20°, or more specifically, between about 8° to 12°, or about 10°, relative to the central axis 782 of the slice osteomy device. non-invasively adjustable 700. A magnetically adjustable actuator 742 comprises an inner shaft 732 telescopically disposed within an outer housing 730, the outer housing 730 further comprising a distraction housing 712 and a gearbox 706. First transverse hole 735, second transverse hole 743, third transverse hole 737 and fourth transverse hole 739 are sized for passage of the bone anchor, e.g. fixation screws having diameters from about 3.0mm to about 5.5mm and more specifically, about 4.0 mm to about 5.0 mm. In some embodiments, the diameter of outer shell 730 is between about 7.0 mm and about 9.5 mm, and more specifically about 8.5 mm. The diameter of the inner shaft 732 may also taper to about 8.5 mm in the portion of the inner shaft 732, containing the second transverse hole 743 and third transverse hole 737. This value is larger than the small diameter portion 784 of the inner rod 732, which shortens within the outer casing 730, and thus this increase in diameter allows the second transverse hole 743 and third transverse hole 737 in turn to be constructed with larger diameters, allowing the use of screws. stronger bone, larger diameter. Likewise, the diameter of the first end 726 can taper to about 10.7 mm in order to allow even larger bone screws to be used. In a non-invasively adjustable slice osteomy device 700 having a housing 730 outside diameter of about 8.5 mm, tapering to about 10.7 mm at the first end 726, and with an inner shaft 732 that tapers upward to about 8.5 mm, it is contemplated that bone screws with a diameter of about 4.0 mm are placed through the second transverse hole 743 and the third transverse hole 737, while bone screws with a diameter of about 5.0 millimeters are placed through the first transverse hole 735 and the fourth transverse hole 739. An exemplary length of the non-invasively adjustable slice osteotomy device 700 of the extensions from the first end 726 to the second end 728 is about 150 mm.
[0104] As can be seen in more detail in FIG. 46, an interface 766 at the first end 726 of the non-invasively adjustable slice osteomy device 700 includes internal threads 797 for reversible engagement with the male threads of an insertion tool. Examples of methods and instrument embodiments that can be used to implant the non-invasively adjustable slice osteomy device 700, or other embodiments of the present invention, are described in US Patent No. 8,449,543, the disclosure of which is incorporated herein. by reference in its entirety. The fourth transverse hole 739 comprises a dynamic construction that allows for some movement between a bone anchor and the non-invasively adjustable slice osteomy device 700 when the non-invasively adjustable slice osteomy device 700 is implanted and being adjusted non-invasively. A bush 751, with substantially cylindrical outer and inner diameters resides within the fourth transverse bore 739 and has an inner diameter 753 configured to smoothly pass the shaft of a locking screw, e.g., a tightening screw with a diameter of about 5 .0 mm. In some embodiments, bushing 751 can be constructed of metallic materials, such as titanium-6A1-4V. In other embodiments, bushing 751 can be constructed of PEEK. Bushing 751 may be angularly unrestricted, thus being capable of swinging or pivoting within the fourth transverse hole 739.
[0105] FIG. 47 shows the non-invasively adjustable slice osteomy device 700 in a first, undistracted state. Inner shaft 732 is substantially retracted within outer shell 730. FIG. 48 shows the non-invasively adjustable slice osteomy device 700 in a partially distracted state, with a portion of the inner shaft 732 extending from the outer casing 730 (e.g., after it has been magnetically distracted). Furthermore, Figs. 47 and 48 show two different possible positions for a bone screw 755, having a head 757, a rod 759 and a threaded portion 761 for engaging cortical bone. Bone screw 755 is described to swing or rotate the torso along a general arcuate path 763. Bushing 751 may generally swing within the fourth transverse hole 739, or bushing 751 may actually pivot over a shaft. For example, the pins may extend transversely to the outer diameter of bushing 751 at approximately the midpoint of its length, and attach into holes or recesses formed transversely within fourth transverse hole 739. The words "pivot" and "rock" , as used herein, are generally intended to indicate a movement that does not have a central rotation point. "Angularly unrestricted" as used herein is intended to denote any freedom of movement of bushing 751 that allows for angulation, not necessarily in a single plane, of bone screw 755 relative to non-invasively adjustable slice osteomy device 700. "Angularly unrestricted", as used herein, is intended to include both swaying and swaying.
[0106] Figs. 49 and 50 illustrate cross-sectional views of bush 751 moving in an angularly constrained fashion within fourth transverse hole 739. As seen in FIG. 51, bushing 751 comprises two large diameter spans 765, 770 and two small diameter spans 767, 768, separated by a transition area 769. In some embodiments, a longitudinal slot 771 along one side of bushing 751 may be present to allow bone screws 755 having a certain amount of outer diameter variation to fit within inner diameter 753. In FIG. 49, bush 751 has not reached its degrees against fourth transverse hole 739. In contrast, FIG. 50 shows a large diameter enlargement 765 abutting a first point 773 within the fourth transverse hole 739, and the other large diameter branch 770 abutting a second point 775 within the fourth transverse hole 739. In addition, this longitudinal slot 771, or alternatively , external contours over bush 751, may fit within contours corresponding to fourth transverse hole 739 so that bush 751 cannot rotate about its cylindrical axis (relative to fourth transverse hole 739), but is still capable of swing or articulate. The sizing of the two large diameter extensions 765, 770 and two small diameter extensions 767, 768 can be controlled, for example, so that the bearing 751 is able to swing or rotate around 15° in one direction, but in about 0° the other direction. This about 15°, for example, can be chosen to correspond to the total amount of osteotomy open slice opening 118 in a particular patient. The extent of this angulation can be controlled on different models of the 751 bushing. For example, about 15° in each direction, about 0° in the other direction; about 10° in one direction, about 5° in the other direction; about 20° in one direction, about 0° in the other direction; and about 10° in one direction, about 10° in the other direction.
[0107] Figs. 52-55 illustrate a method of implanting and operating the non-invasively adjustable slice osteomy device 700 of FIGS. 45A-51 for maintaining or adjusting a slice angle of a patient tibial opening osteotomy. In FIG. 52, a first cavity 109, extending from a first point of tibia 102 on tibial plate 101, is made. In some embodiments, first cavity 109 may be made as shown in FIGS. 20-22. In FIG. 53, the non-invasively adjustable slice osteomy device 700 is inserted into the first cavity 109, the inner shaft 732 first, followed by the outer casing 730. In Figure 54, the non-invasively adjustable slice osteomy device 700 is secured to the first portion 119 of the tibia 102 with a first bone screw 755, which is passed through the fourth transverse hole 739 of FIG. 45B, and a second bone screw 777 passes through the first transverse hole 735 of FIG. 45B. In this embodiment, only the fourth transverse hole 739 has the bush 751 incorporated therein. A third bone screw 779 and a fourth bone screw 781 are passed through the second transverse hole 743 in FIG. 45B, and the third transverse hole 737, in FIG. 45B, respectively, and secured to the second portion 121 of the tibia 102. The non-invasively adjustable slice osteomy device 700 is secured within the tibia 102 so that the Herzog curve 780 of FIG. 45A, points anteriorly (eg to the patellar tendon). FIG. 55 illustrates the non-invasively adjustable slice osteomy device 700 after it has been distracted through one or more non-invasive distractions over a period of one or more days. The angle of the open slice osteotomy 118 was increased as the inner axis 732 was displaced out of the outer casing 730. The bone screw 755 was able to change its angle relative to the non-invasively adjustable slice osteomy device 700 , for example, by shaking or pivoting bush 751 of FIG. 49 inside the fourth transverse hole 739.
[0108] Figs. 56A to 56D illustrate four possible bone screw configurations for securing the first end 726 of the non-invasively adjustable slice osteomy device 700 to the first portion 119 of the tibia 102 with the first bone screw 755 and the second bone screw 777. medial 800, lateral 802, anterior 804, and posterior 806 portions of tibia 102 are denoted. The medial portion 800 and the lateral portion 802 in FIGS. 56A to 56D is left to right, respectively, in each figure, while in Figs. 52 to 55, medial was on the right and lateral was on the left. In the configuration of fig. 56A, the first bone screw 755 is fixed unicortically (across the tibial cortex 102 on one side only) and forms an angle B of ~10° with the lateral-medial axis 810. The second bone screw 777 is fixed bicortically ( through, the cortex of the tibia 102 on both sides) and forms an angle A of ~20° with the anterior-posterior axis 808. In the configuration of fig. 56B, the first bone screw 755 is fixed unicortically and makes an angle B of ~10° (in the opposite direction as in FIG. 56A) with the lateral-medial axis 810. The second bone screw 777 is fixed bicortically and forms an angle A of ~ 20 ° with the anterior-posterior axis 808. In the configuration of fig. 56C, the first bone screw 755 and the second bone screw 777 are both bicortically secured. The first bone screw 755 is fixed at an angle D of ~45° with the anterior-posterior axis 808, and the second bone screw 777 is fixed at an angle of A~20° with the anterior-posterior axis 808. In the configuration in Fig . 56D, the first bone screw 755 and the second bone screw 777 are both bicortically secured. The first bone screw 755 is fixed at an angle of D ~ 45° with the anterior-posterior axis 808, and the second bone screw 777 is fixed at an angle E of ~45° with the anterior-posterior axis 808.
[0109] Although not shown in FIGS. 56A through 56D, the third bone screw 779 and the fourth bone screw 781 can be secured in various orientations. Although shown in FIGS. 54 and 55, oriented slightly inclined to the anteroposterior plane, they can also be placed in other orientations, for example an angle of approximately 35 ° to the lateral-medial plane.
[0110] Fig. 57 illustrates a non-invasively adjustable slice osteomy device 900. The non-invasively adjustable slice osteomy device 900 comprises an adjustable magnetic actuator 942 has a first end 926 and a second end 928, and is similar in construction to the non-invasively adjustable slice osteomy device 300 of the Figures. 17-19. The second end 928 includes an inner shaft 932 having a small diameter portion 984 that is telescopically and axially displaceable within an outer housing 930. The outer housing 930 comprises a distraction housing 912 and a gearbox 906. A first plate 950 extends from the outer housing 930 and is configured to be placed in proximity to an outer surface of a bone, e.g., the second portion 121 of a tibia 102 shown in FIG. 59. One or more mounting holes 952 is formed in the first plate 950, and configured to interface with corresponding bone screws. A bone screw 954 is shown in FIG. 58, and includes a threaded connection, taper head 956 and a threaded shaft 958, a pair of keyed cavity 960 with a motive instrument (not shown). The first plate 950 has a bone interface side 962 and a non-bone interface side 964. A second plate 966, which has a bone interface side 968 and a non-bone interface side 970, extends from the inner axis 932. The second plate 966 is coupled to the inner shaft 932 by a cover 972, and secured with a set screw 974. One or more anchor holes 976 are disposed on the second plate 966, and configured to interface with the corresponding bone screws, for example, bone screw 954. Anchor hole 978 is shown having a threaded taper 980, to interface with the tapered head 956 of bone screw 954.
[0111] Figs. 59-61 illustrate a method of implanting and operating the non-invasively adjustable slice osteomy device of FIG. 57 for maintaining or adjusting a tibial opening slice osteotomy angle of a patient. In FIG. 59, an opening slice osteomy 118 is made in the tibia 102. In FIG. 60, the non-invasively adjustable slice osteomy device 900 is placed through an incision and is secured to the tibia 102 by coupling the first plate 950 to the second portion 121 of the tibia 102 and coupling the second plate 966 to the first portion of 119 of the tibia, for example, with bone screws 954. FIG. 61 illustrates the tibia 102 after the non-invasively adjustable slice osteomy device 900 has been non-invasively distracted, for example, with the external adjustment device 1180.
[0112] Figs 62 and 63 illustrate a non-invasively adjustable slice osteomy device 1000. The non-invasively adjustable slice osteomy device 1000 comprises an adjustable magnetic actuator 1042 having a first end 1026 and a second end 1028, and is of similar construction to the non-invasively adjustable slice osteomy device 300 of FIGS. 17-19, and the non-invasively adjustable slice osteomy device 900 of FIG. 57. Magnetically adjustable actuator 1042 comprises an outer casing 1030 and an inner shaft 1032 telescopically disposed within the outer casing 1030. Like the non-invasively adjustable slice osteomy device 900 of FIG. 57, the non-invasively adjustable slice osteomy device 1000 has a first plate 1050 extending from the outer shell 1030. A second plate 1066 is secured to the inner shaft 1032 by a cap 1072. The second plate 1066 is coupled to rotatable shape in cap 1072 to pivot point 1091, thus allowing second plate 1066 to rotate from the position in FIG. 62 to the position in FIG. 63 along arrow 1081, for example, as the inner axis 1032 is distracted from the position in FIG. 62 to the position in FIG. 63. This allows the first portion 119 of the tibia 102 to be moved beyond the second portion 121 of the tibia 102, and thus opening the open slice osteotomy 118, but without creating large bending moments (increased friction and force and alike) on the movement of the inner shaft 1032 within the outer casing 1030. In this way, the torque provided by the magnetic coupling of the outer adjustment device 1180 of FIG. 15 will be sufficient to distract the magnetically adjustable actuator 1042. The ability to rotate the second plate 1066 relative to the rest of the non-invasively adjustable slice osteomy device 900 is analogous to the angularly unrestricted movement of the bush 751 and the screw bone 755 with respect to the non-invasively adjustable slice osteomy device 700 of FIGS. 45A to 50.
[0113] The use of the non-invasively adjustable slice osteomy device 900 or the non-invasively adjustable slice osteomy device 1000, which do not require any bone removal in tibial plateau 101, may be preferred in certain patients in the which is desired to keep the knee joint 104 in as original a condition as possible. This may include younger patients, patients who may be able to avoid knee replacement after partial or complete, or patients with knee deformities 104. It may also include smaller patients who have intramedullary devices that will not fit well.
[0114] Figs. 64A through 64C illustrate an adjustable magnetic actuator 1504 that can be used with any of the embodiments of the present invention, and that allows for the temporary or permanent removal of a rotating magnetic assembly 1542. Patients undergoing magnetic resonance imaging (MRI) may require the radially polarized permanent magnet 1.502 is removed prior to magnetic resonance in order to avoid an image artifact that can be caused by the radially polarized permanent magnet 1502. In addition, there is a risk that an implanted radially polarized permanent magnet -1502 may be demagnetized about an MRI scanner. In some embodiments, a housing cover of actuator 1588 has a male thread 1599 that engages with a female thread 1597 of the outer casing 1505 of the magnetically adjustable actuator 1504. In other embodiments, a pressure/disengagement interface may be used. A 1595 smooth diameter portion of the 1588 actuator housing cover is sealed within a sealing ring 1593 which is held within a circumferential groove in the outer housing 1505. 1504 If the rotating magnet assembly 1542 were to be removed, leaving the rest of the implant intact, a small incision could be made in the subject's skin in proximity to the 1588 actuator housing cover, and the 1588 drive housing cover could be unscrewed. . The rotating magnet assembly 1542 can then be removed, as shown in FIG. 64A. FIGS. 64B and 64C show the subsequent steps of replacing the 1588 actuator housing cover for the 1504 magnetically adjustable actuator, again sealing it with the 1593 O-ring. The incision can then be closed, and the patient can be subjected to to typical MRI resonance. If desired, after MRI scanning, magnet assembly 1542 can be replaced following a reverse method.
[0115] Figs. 65A to 65D illustrate an adjustable magnetic actuator 1604 which can be used with any of the embodiments of the present invention, and which advantageously allows for the temporary or permanent removal of the radially polarized permanent magnet 1602. An actuator housing cover 1688 and attaches separates Magnetically adjustable actuator 1604 is used in the same manner as magnetically adjustable actuator 1504 of FIGS. 64A to 64C. The radially polarized permanent magnet 1602 has two radially polarized portions 1687 and two flat portions 1685. The two flat portions 1685 fit within the flat walls 1683 of a magnetic housing 1640, which allows rotation of the radially polarized permanent magnet 1602 to directly transmit torque over the 1640 magnetic casing without the need for any adhesive or epoxy. A cover of magnetic housing 1681 with a sealing ring 1679 is attachable to and removable from magnetic housing 1640. If an MRI of the subject is desired and it has been determined that the radially polarized permanent magnet 1602 must be removed, a small incision is made on the subject's skin in proximity to the 1688 actuator housing cover, and the 1688 drive housing cover is removed. Then, the cover of magnetic housing 1681 is removed from magnetic housing 1640. A tie rod 1677 extends through a longitudinal hole (not shown) in the radially polarized permanent magnet-1602, which extends at one end so that it can be grasped, for example, using forceps or hemostats. The drawbar 1677 may have a flat base 1675 at the opposite end, so that when it is pulled, it can drag the radially polarized permanent magnet 1602 with it. The radially polarized permanent magnet 1602 can be permanently or temporarily removed (FIG. 65B) (removal path 1691) and from the cover of magnetic housing 1681 replaced (FIG. 65C). The 1688 actuator housing cover is replaceable (FIG. 65D). The incision is then closed, and the subject can undergo typical MRI resonance. If desired, after magnetic resonance imaging, the radially polarized permanent magnet-1602 can be replaced, following a reverse method. Alternatively, magnetic housing cover 1681 or actuator housing cover 1688 can be replaced with an alternatively shaped cover that guides to a keyway within magnet actuator 1604, thus maintaining internal mechanisms. of turning, and keeping the particular amount of the adjustment object from altering while the subject walks, runs or stretches.
[0116] Throughout the presented embodiments, a radially polarized permanent magnet 168 (eg of FIG. 8), as part of a magnetic assembly (eg 166), a driving element is used to remotely create motion in a non-invasively adjustable slice osteomy device. FIGS. 66 to 69 schematically show four alternative embodiments, in which other types of energy transfer are used in place of permanent magnets.
[0117] FIG. 66 illustrates a non-invasively adjustable slice osteomy device 1300 comprising an implant 1306 having a first portion of the implant 1302 and a second portion of the implant 1304, the second portion of the implant 1304 displaceable non-invasively with respect to the first implant portion 1302. First implant portion 1302 is secured to a first bone portion 197 and second implant portion 1304 is secured to a second bone portion 199 within a patient 191. A motor 1308 is operable to make whereby the first implant portion 1302 and the second implant portion 1304 move relative to each other. An external adjustment device 1310 has a control panel 1312 for operator input, a display 1314 and a transmitter 1316. Transmitter 1316 sends a control signal 1318 through the skin 195 of patient 191 to a receiver 1320. The implantable 1320 communicates with the motor 1308 through a conductor 1322. The motor 1308 can be powered by an implantable battery, or it can be powered or charged by the inductive coupling.
[0118] FIG. 67 illustrates a non-invasively adjustable slice osteomy device 1400 comprising an implant 1406 having a first portion of the implant 1402 and a second portion of the implant 1404, the second portion of the implant 1404 being non-invasively displaceable relative to to the first implant portion 1402. The first implant portion 1402 is secured to a first bone portion 197 and the second implant portion 1404 is secured to a second bone portion 199 within a patient 191. An ultrasonic motor 1408 is operable to cause the first implant portion 1402 and the second implant portion 1404 to move relative to each other. An external adjustment device 1410 has a control panel 1412 for operator input, a display 1414 and an ultrasonic transducer 1416, which is attached to the skin 195 of the patient 191. The ultrasonic transducer 1416 produces ultrasound waves 1418, which pass through the skin 195 of patient 191 and operate the ultrasonic motor 1408.
[0119] FIG. 68 illustrates a non-invasively adjustable slice osteomy device 1700 comprising an implant 1706 having a first portion of the implant 1702 and a second portion of the implant 1704, the second portion of the implant 1704 being non-invasively displaceable relative to to the first implant portion 1702. The first implant portion 1702 is secured to a first bone portion 197 and the second implant portion 1704 is secured to a second bone portion 199 within a patient 191. An actuator 1708 with memory of shape is operable to cause the first implant portion 1702 and the second implant portion 1704 to move relative to each other. An external adjustment device 1710 has a 1712 control panel for operator input, a 1714 dislay, and a 1716 transmitter. The 1716 transmitter sends a 1718 control signal through the skin 195 of the patient 191 to a 1720 receiver. The implantable 1720 communicates with the shape memory actuator 1708 through a conductor 1722. The shape memory actuator 1708 can be powered by an implantable battery, or it can be powered or charged by inductive coupling.
[0120] FIG. 69 illustrates a non-invasively adjustable slice osteomy device 1800 comprising an implant 1806 having a first portion of the implant 1802 and a second portion of the implant 1804, the second portion of the implant 1804 being non-invasively displaceable relative to to the first implant portion 1802. The first implant portion 1802 is secured to a first bone portion 197 and the second implant portion 1804 is secured to a second bone portion 199 within a patient 191. A hydraulic pump 1808 is operable to cause the first implant portion 1802 and the second implant portion 1804 to move relative to each other. An 1810 external adjustment device has an 1812 control panel for input to an operator, an 1814 display, and an 1816 transmitter. The 1816 transmitter sends an 1818 control signal through the skin 195 of the patient 191 to an 1820 receiver. implantable 1820 communicates with hydraulic pump 1808 via a conductor 1822. Hydraulic pump 1808 may be powered by an implantable battery, or it may be powered or charged by inductive coupling. The hydraulic pump 1808 can alternatively be replaced by a pneumatic pump.
[0121] In one embodiment, a system of changing an angle of a bone of a subject includes an adjustable actuator having an outer casing and an inner shaft, telescopically disposed in the outer casing; a magnetic assembly configured to adjust the length of the adjustable actuator during axial movement of the inner shaft and outer casing relative to each other; a first support configured for coupling with the outer shell; a second support configured for coupling with the inner shaft; and wherein applying an externally moving magnetic field to the subject moves the magnetic assembly such that the inner shaft and outer casing move relative to each other.
[0122] In another embodiment, a system of changing an angle of a bone of a subject includes a magnetic assembly comprising a radially polarized magnet coupled to a shaft that has external threads; a block having internal threads and coupled to the shaft, wherein the rotational movement of the radially polarized magnet causes the shaft to rotate and move axially with respect to the block; an upper bone interface and a lower bone interface having an adjustable distance; and where axial movement of the shaft in a first direction causes the distance to increase. The upper and lower bone interfaces can be formed as part of a plate spring. The upper and lower bone interfaces can be formed as part of a plurality of interconnected plates.
[0123] In another embodiment, a system of changing an angle of a bone of a subject includes a scissor assembly comprising a first and second scissor arms rotatably coupled through a hinge, the first and second scissor arms coupled, respectively, to upper and lower bone interfaces configured to move relative to one another; a hollow magnetic assembly having an axially movable threaded spindle disposed therein, wherein the hollow magnetic assembly is configured to rotate in response to a moving magnetic field and wherein said translation of rotation into axial movement of the guide screw; a ratchet assembly coupled at one end to the lead screw and at the other end to one of the first and second scissors arms, the ratchet assembly comprising a pawl configured to engage teeth disposed at one of the upper and lower bone interfaces; and where the axial movement of the lead screw advances the pawl along the teeth and moves the upper and lower bone interfaces away from each other
[0124] In another embodiment, a method of preparing a tibia for implantation of a displacement implant includes making a first incision in a patient's skin at a location adjacent to the tibial plateau of the patient's tibia; creating a first cavity in the tibia by removing bone material along a first axis extending in a substantially longitudinal direction from a first point on the tibial plateau to a second point; placing an excavating device within the first cavity, the excavating device including an elongated main body configured to excavate the tibia asymmetrically with respect to the first axis; creating a second cavity in the tibia with the cupping device, wherein the second cavity communicates with the first cavity and extends substantially to one side of the tibia; and removing the digging device. The second cavity may extend substantially laterally into the patient. The second cavity may extend substantially medially in the patient. The method may further include compacting a portion of the trabecular bone of the tibia in creating a second cavity pass. The digging device may comprise an articulated arm having a first end and a second end, the arm including a compaction surface. The compaction surface may include a leading edge and at least one angled surface. The arm can be adjustable relative to the elongated main body. The first end of the arm can be hingedly coupled to the elongated main body and the second end of the arm can be adjusted for a plurality of distances from the elongated main body. The excavating device can be coupled to an adjustment element configured to move the second end of the arm at least one of the plurality of distances from the elongated body. Creating a second cavity pitch may further comprise adjusting the adjustment member to move the second end of the arm along at least several of the plurality of distances from the elongated main body such that the compaction compacts the cancellous bone against the cortical bone. Creating a second cavity step can include removing bone material from the tibia. The excavating device may comprise an articulated arm having a first end and a second end, the arm including an abrasive surface. The abrasive surface may comprise a scrape. The arm can be adjustable relative to the elongated main body. The first end of the arm can be hingedly coupled to the elongated main body and the second end of the arm can be adjusted for a plurality of distances from the elongated main body. The excavating device may be coupled to an adjustment element configured to move the second end of the arm at least one of the plurality of distances from the elongated main body. Creating a second cavity step may further comprise moving the excavating apparatus longitudinally along a bidirectional path approximately corresponding to the first axis and adjusting the adjusting element to move the second end of the arm of at least one of the plurality of distances from the elongated main body such that the abrasive surface removes material from the bone. The elongated main body may comprise a rotary cutting tool having a first end, a second end, a cutting zone extending at least partially between the first and second ends, and a circumferential engaging member and the cutting device. The excavation may further comprise a flexible pulling unit configured to engage the circumferential engagement member. The step of placing an excavation device may further comprise creating a pathway through the cortical bone on at least one side of the tibia, inserting the flexible traction unit through a pathway, and coupling the flexible drive train to the tool. rotary cutting tool, so that the movement of the flexible drive train causes rotation of the rotary cutting tool. Creating a second cavity step may further comprise moving the circumferential engagement member of the rotating cutting tool substantially to one side of the tibia while the rotating cutting tool is being rotated by the flexible drive train. Flexible drive train can be moved by drive unit. The rotary cutting tool can be used to create the first cavity. The rotating cutting tool may comprise a reamer. The first end of the rotating cutting tool may comprise a blunt tip. The second end of the rotary cutting tool can be coupled to a retrieval anchor group that extends from the first incision. The recovery rod can be coupled to the rotary cutting tool by a swivel joint. The removal step may comprise removing the rotational cutting tool, applying tension to the retrieval rod from a location external to the patient. The method may further comprise the step of creating an osteotomy between a first portion and a second portion of the tibia, wherein the flexible drive train extends through the osteotomy.
[0125] In another embodiment, a method of implanting a non-invasively adjustable system to change an angle of a patient's tibia includes creating an osteotomy between a first portion and a second portion of the tibia; making a first incision in the patient's skin at a site adjacent to the tibial plateau of the patient's tibia; creating a first cavity in the tibia along a first axis extending in a substantially longitudinal direction from a first point on the tibial plateau to a second point; placing an excavating device within the first cavity, the excavating device configured to excavate the tibia asymmetrically with respect to the first axis; creating a second cavity in the tibia with the cupping device, wherein the second cavity extends substantially to one side of the tibia; placing a non-invasively adjustable implant through the first well and at least partially into the second well, the non-invasively adjustable implant comprising an adjustable actuator having an outer casing and an inner axis, telescopically disposed in the outer casing; coupling the outer casing to the first portion of the tibia; and coupling the inner rod to the second portion of the tibia. The first part can be superior to the osteotomy and the second part can be below the osteotomy. The first portion can be below the osteotomy and the second portion can be above the osteotomy. The second cavity can communicate with the first cavity. The method may further comprise step non-invasively causing the inner shaft to move relative to the outer shell. The non-invasively adjustable implant may comprise a drive element configured to move the inner axis relative to the outer shell. The drive element can be selected from the group comprising: a permanent magnet, an inductively coupled motor, an ultrasonically driven motor, a subcutaneous hydraulic pump, a subcutaneous pneumatic pump, and a shape-oriented memory actuator.
[0126] In another embodiment, a method of preparing a bone for implantation of an implant includes making a first incision in the skin of a patient; creating a first cavity in the bone, removing bone material along a first axis extending in a substantially longitudinal direction from a first point to a second point; placing an excavating device within the first cavity, the excavating device including an elongated main body configured to excavate the bone asymmetrically with respect to the first axis, the excavating device further comprising an articulated arm having a first end and a second end, the arm including a compaction surface; creating a second cavity in the bone with the cupping device, wherein the second cavity communicates with the first cavity and extends substantially to one side of the bone; and removing the digging device.
[0127] In another embodiment, a method of preparing a bone for implantation of an implant includes making a first incision in the skin of a patient; creating a first cavity in the bone by withdrawing bone material along a first axis extending in a substantially longitudinal direction from a first point to a second point; placing an excavating device within the first cavity, the excavating device including an elongated main body configured to excavate the bone asymmetrically with respect to the first axis, the excavating device further comprising an articulated arm having a first end and a second end, the arm including an abrasive surface; creating a second cavity in the bone with the cupping device, wherein the second cavity communicates with the first cavity and extends substantially to one side of the bone; and removing the digging device.
[0128] In another embodiment, a method of preparing a bone for implantation of an implant includes making a first incision in the skin of a patient; creating a first cavity in the bone, removing bone material along a first axis extending in a substantially longitudinal direction from a first point to a second point; placing an excavating device within the first cavity, the excavating device including an elongated main body configured to excavate the bone asymmetrically with respect to the first axis, the excavating device further comprising a configured rotary cutting tool to be moved substantially towards one side of the bone while the rotary cutting tool is being rotated; creating a second cavity in the bone with the cupping device, wherein the second cavity communicates with the first cavity and extends substantially to one side of the bone; and removing the digging device.
[0129] In another embodiment, a system of changing an angle of a patient's bone includes a non-invasive implant is adjustable, comprising an adjustable actuator having an outer casing and an inner shaft, telescopically disposed in the outer casing, the casing the outer shaft configured to mate with a first part of the bone, and the inner shaft configured to mate with a second part of the bone; a drive element configured to move the inner axis with respect to the outer casing; and an excavating device including an elongated main body configured to insert into a first bone cavity along a first axis, the excavating device configured to excavate bone asymmetrically with respect to the first axis to create a second cavity that communicates with the first cavity, wherein the adjustable actuator is configured to be coupled to bone at least partially within the second cavity. The drive element can be selected from the group comprising: a permanent magnet, an inductively coupled motor, an ultrasonically driven motor, a subcutaneous pump, and a shape-oriented memory actuator. The excavation device can be configured to compact cancellous bone. The excavating device may comprise an articulated arm having a first end and a second end, the arm including an abrasive surface. The abrasive surface may comprise a scrape. The excavating device may comprise a rotary cutting tool having a first end, a second end, a cutting zone extending at least partially between the first and second ends, and a circumferential engaging member, and the device. The excavator may further comprise a flexible pulling unit configured to engage the circumferential engagement member.
[0130] In another embodiment, a system of changing an angle of a patient's bone includes a non-invasively adjustable implant, comprising an adjustable actuator having an outer casing and an inner shaft, telescopically disposed in the outer casing, the outer casing configured to engage a first bone portion, and the inner shaft configured to engage a second bone portion; and a drive element configured to move the inner shaft relative to the outer casing, wherein the drive element is selected from the group comprising: a permanent magnet, an inductively coupled motor, an ultrasonically driven motor, a hydraulic pump via subcutaneous, a pneumatic subcutaneous pump, and a shape-oriented memory actuator. The driving element may comprise a permanent magnet.
[0131] In another embodiment, a system of changing at an angle of a tibia of a subject with osteoarthritis of the knee includes a non-invasively adjustable implant comprising an adjustable actuator having an outer casing and an inner axis, telescopically disposed on the outer shell, the outer shell having a first transverse hole, and the inner shaft having a second transverse hole; a drive element configured to move the inner shaft relative to the outer casing, wherein the drive element is selected from the group comprising: a permanent magnet, an inductively coupled motor, an ultrasonically driven motor, a subcutaneous hydraulic pump , a subcutaneous pneumatic pump, and a shape-oriented memory actuator; a first anchor configured to place through the first transverse hole and to engage a first portion of the tibia; and a second fastener configured to place through the second transverse hole and to engage a second portion of the tibia, wherein at least one of the first and second anchorage fasteners is configured to be pivotable relative to the non-invasively adjustable implant when coupled to either the first portion or the second portion of the tibia. The driving element may comprise a permanent magnet.
[0132] In another embodiment, a method of modifying a bone angle includes creating an osteotomy between a first portion and a second portion of a patient's tibia; creating a cavity in the tibia by withdrawing bone material along an axis extending in a substantially longitudinal direction from a first point on the tibial plateau to a second point; the placement of an adjustable non-invasive implant into the cavity, the non-invasively adjustable implant comprising an adjustable actuator having an outer shell and inner shaft, telescopically disposed in the outer shell, and a drive element configured to be remotely operable to telescopically shift the inner axis with respect to the outer casing; coupling one of the outer or inner casing of the shaft to the first portion of the tibia; coupling the other of the outer casing or inner shaft to the second portion of the tibia; and remotely operating the drive element to telescopically shift the inner shaft with respect to the outer shell, thereby changing an angle between the first portion and the second portion of the tibia.
[0133] While embodiments of the present invention have been shown and described, various modifications can be made without departing from the scope of the present invention. Any of the embodiments of the non-invasively adjustable slice osteomy device can be used for gradual distraction (Ilizarov osteogenesis) or for correction of an incorrect acute angle. The implant can itself be used as any of the elements of the excavation device, for example the outer portion of the implant can have features that allow it to be used as a bone reamer, scraper or compactor. As an alternative, the remote adjustment described above can be replaced by a manual control of any implanted part, for example, manual pressure by the patient or carer of a button placed under the skin. The invention, therefore, is not to be limited except by the following claims and their equivalents.
[0134] It is contemplated that various combinations or subcombinations of the characteristics and specific aspects of the embodiments described above can be made and still fall within one or more of the inventions. In addition, the disclosure herein of any special feature, aspect, method, property, feature, quality, attribute, component, or the like in connection with one embodiment may be used in all other embodiments presented herein. Therefore, it is to be understood that various features and aspects of the described embodiments may be combined with or substituted for one another in order to form different modes of the disclosed inventions. Thus, it is intended that the scope of the present inventions described herein should not be limited by the particular disclosed embodiments described above. Furthermore, although the invention is susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and are described in detail herein. It should be understood, however, that the invention is not to be limited to the particular forms or methods described, but rather, the invention covers all modifications, equivalents and alternatives that fall within the spirit and scope of the various embodiments described and the claims attached. Any methods described here need not be performed in the order recited. The methods disclosed here include certain actions taken by a professional; however, they may also include any third party instructions for these actions, either expressly or by implication. For example, actions such as “the insertion of a bone reamer for the first part of' include "instructing the insertion of a bone reamer for the first part". , and their combinations. Language such as "until", "at least", "greater than", "less than", "between", and the like includes the recited number. Numbers preceded by a term such as "approximately", "about ", and "substantially" used herein include the numbers recited, and also represent an amount close to the stated value that still performs a desired function or achieves a desired result. For example, the terms "about", "approximately" and "substantially " may refer to an amount that is, in less than 10% of, within less than 5% of, in less than 1% of, within less than 0.1% of, and within less than than 0.01% of the indicated amount.

权利要求:
Claims (5)
[0001]
1. A system for changing an angle of a subject bone, the system comprising: a non-invasively adjustable implant (700) comprising an adjustable actuator (742) having an outer casing (730) and an inner shaft ( 732), telescopically disposed in the outer shell (730), the outer shell (730) associated with a first anchor hole (739), and the inner shaft (732) associated with a second anchor hole (743), the first hole anchor (739) configured to transmit a first fastener (755) for adjustable actuator engagement (742) of a first bone portion and second anchor hole (743) configured to transmit a second fastener (779) for actuator engagement adjustable (742) with a second bone portion, the second bone portion separated at least partially from the first bone portion by an osteotomy; a drive element configured to be remotely operable to telescopically displace the inner shaft (732) relative to the outer casing (730); and wherein the non-invasively adjustable implant (700) is configured to be angularly unrestricted with respect to the call minus one of the first bone portion or the second bone portion when coupled to both the first bone portion and the second bone portion; characterized in that the inner shaft (732) is tapered having a first smaller diameter adjacent the outer casing (730) to a second larger diameter distal to the outer casing (730).
[0002]
2. System according to claim 1, characterized in that the drive element comprises a permanent magnet.
[0003]
3. System according to claim 1, characterized in that the drive element comprises an inductively coupled motor.
[0004]
4. System according to claim 1, characterized in that the drive element comprises an ultrasonically driven motor.
[0005]
5. System according to claim 1, characterized in that the drive element comprises a subcutaneous hydraulic pump.

类似技术:

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公开号 | 公开日 | 专利标题

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同族专利:

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公开号 | 公开日

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CN104902854B|2017-10-03|

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US20150223854A1|2015-08-13|

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RU2015120291A|2016-12-27|

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CN104902854A|2015-09-09|

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EP2911616A4|2016-07-13|

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BR112015009446A2|2017-07-04|

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AU2013338218B2|2017-05-04|

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IN2015DN03762A|2015-10-02|

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US20140155946A1|2014-06-05|

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US11191579B2|2021-12-07|

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CA2889769A1|2014-05-08|

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WO2014070681A1|2014-05-08|

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EP2911616B1|2020-10-07|

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US20190159817A1|2019-05-30|

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US20190046252A1|2019-02-14|

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WO2014070681A8|2015-05-21|

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EP2911616A1|2015-09-02|

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RU2017126066A|2019-01-31|

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US10130405B2|2018-11-20|

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US11213330B2|2022-01-04|

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AU2013338218A1|2015-05-21|

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EP3760147A1|2021-01-06|

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法律状态:
2018-04-24| B25A| Requested transfer of rights approved|Owner name: NUVASIVE, INC. (US) |

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2018-05-15| B25A| Requested transfer of rights approved|Owner name: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. (US) |

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2018-11-21| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2019-12-03| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2021-05-11| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2021-07-20| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 28/10/2013, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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US201261719887P| true| 2012-10-29|2012-10-29|

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US61/719,887|2012-10-29|

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US201361868535P| true| 2013-08-21|2013-08-21|

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US61/868,535|2013-08-21|

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