WO2008015679A2 - Système et procédé de surveillance de déplacements d'objets in vivo - Google Patents
Système et procédé de surveillance de déplacements d'objets in vivo Download PDFInfo
- Publication number
- WO2008015679A2 WO2008015679A2 PCT/IL2007/000966 IL2007000966W WO2008015679A2 WO 2008015679 A2 WO2008015679 A2 WO 2008015679A2 IL 2007000966 W IL2007000966 W IL 2007000966W WO 2008015679 A2 WO2008015679 A2 WO 2008015679A2
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- recs
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; determining position of probes within or on the body of the patient
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
- A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb
- A61B5/1126—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb using a particular sensing technique
- A61B5/1127—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb using a particular sensing technique using markers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/45—For evaluating or diagnosing the musculoskeletal system or teeth
- A61B5/4504—Bones
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/06—Measuring instruments not otherwise provided for
- A61B2090/061—Measuring instruments not otherwise provided for for measuring dimensions, e.g. length
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
- A61B5/6878—Bone
Definitions
- the present invention relates to systems and methods for monitoring displacement between in vivo objects such as, artificial joint members, vertebrae, and segments of fractured or dissected bones. More specifically, embodiments of the present invention relate to systems capable of detecting variations of the distance, and/or relative orientations, between for example, vertebrae, or segments of a bone thus enabling to determine, relative displacement and/or rotations between them.
- the accuracy of monitoring the progress or regression of clinical syndromes regarding bone healing, bone union, bone growth and bone absorption is particularly important in orthopedic procedures.
- Exemplary procedures are surgery of the spine, trauma of the bones, chest bone (sternum) surgery and heart and lung surgical procedures.
- Early accurate diagnosis of the nature of post operative course is of paramount importance for providing data that may herald the necessity of modifying the treatment by medications that prevent bone absorption, such as biphosphonates (Wilkinson JM et al. J. Orthop. Res. 23(1): 1-8, 2005) and promote bone formation such as BMP (Clin Orthop. 417:50-61 , 2003) and Teriparatide (J Clin Endocrinol Metab.
- monitoring is done by imaging modalities such as X Rays (Roentgen), CT, MRI, nuclear imaging and/or Scintimetry which frequently are of insufficient quality due to low resolution, subjective interpretation (observer dependant), disruption by metals and confusion by difficult anatomic structures.
- imaging systems are located remote from most of the clinical physicians, therefore results are often delayed, are more expensive and most of the technologies carry the risk of irradiation.
- Both disclosed systems include: a resonant circuit; a magnetic element having a predetermined structure, geometrical shape and magnetic properties; a transmitter operable to transmit an electromagnetic pulse; a receiver operable to detect oscillations emitted by the resonant circuit in response to said electromagnetic pulse, and an analyzer operable to analyze an amplitude envelope feature and/or the frequency of the oscillations, to thereby determine a distance between the resonant circuit and the magnetic element.
- Fig. 1 is a simplified block diagram of a system for monitoring displacements of in vivo objects according to the present invention
- Fig. 2 is a synthetic description of the signals generated by a system of the invention
- Fig. 3 is an exemplary frequency-distance profile of a system for monitoring displacements of in vivo objects according to the invention
- Figs 4 - 6 schematically describe placements of resonant electric circuits of a system for monitoring displacements according to the present invention respectively applied onto three different bones;
- Fig. 7 presents typical frequency-distance profiles measured for a pair of resonant electric circuits one of which is relatively inclined towards the other in different angles respectively;
- Fig. 8 is a graph of the resonance frequency versus distance measured for two exemplary pairs of resonant electric circuits affixed to two segments of sternum suspended in saline solution;
- a system and method for monitoring displacements and or rotations of in vivo objects is provided. Such system is referred hereinafter by either system of the invention or system for monitoring displacements.
- a system of the invention has at least one pair of magnetically coupled resonant electric circuits (RECs); a transmitter operable in exciting oscillations in each of these RECs; a receiver operable in receiving the electromagnetic radiation emitted by the simultaneously oscillating RECs, and a processor for signal and data processing and for deriving resonance frequencies and further analyzing the measurements' results.
- An operator interface linked to the processor provides for displaying and inputting data to, or by, an operator as known.
- Such a pair of RECs respectively attached to a pair of in vivo objects is first irradiated by means of the transmitter. Any relative motion of these objects effect the magnetic coupling between the RECs, thereby modifying features of the signals received.
- the system of the invention provides for determining whether such modified signals are associated with relative displacements and/or rotations of the objects to be monitored.
- FIG. 1 a simplified block diagram of a system for monitoring in accordance with the present invention is shown.
- System for monitoring displacements 10 has one or more pairs, such as pair 12, of magnetically coupled but electrically isolated RECs 14.
- RECs 14 are affixed unto in vivo objects whose relative displacements and/or rotations are to be monitored, such as segments 16 of a broken bone.
- Transmitter 18 having either a programmable pulse generator or CW generator operating at a specified band of frequencies feeds transmitting antenna 20 to radiate electromagnetic waves. Such transmissions excite the two coupled RECs 14 to simultaneously oscillate.
- the electromagnetic radiation induced by these oscillations is received in receiver unit 22 by means of dedicated receiving antenna 24.
- Sampling and digitizing unit 26 which is synchronized with transmitter 18, samples the received signals at a predefined sampling rate and digitizes them at a predefined dynamic range.
- the digitized data are temporarily stored in a buffer memory of sampling and digitizing unit 26 to be transferred to processor 28 for further processing and analysis.
- Operator interface 29 provides for inputting setup and/or working parameters, activating the system and for displaying an operator with the results of the measurements.
- Optional link to a computer of a back office not shown, provides for uploading data related to the measurements and downloading system working parameters, as known.
- a common laptop computer implements processor 28 and operator interface 29 according to an embodiment of the present invention.
- Coupling a pair of resonant circuit is effected by disposing them such that the distance between their centers does not exceed a predefined threshold whose magnitude is dependent on their relative orientation.
- the resonance frequency of each REC of a pair of magnetically coupled RECs is varying with their relative distance and orientation. Therefore a displacement and/or rotation of any member of such pair relative to the other causes the resonance frequencies to respectively change.
- Monitoring such in vivo displacements and/or rotations is accomplished in accordance with the present invention by comparing currently measured resonance frequencies with pre-stored frequencies associated with this pair of RECs.
- Synthetic time profiles representing the actual electric signals transmitted and received by an exemplary system of the invention employing pulsed transmissions are shown in Fig. 2.
- Plot 30 is a time profile of a transmitted DC pulse
- plot 32 is a time profile of an oscillation excited in any of the coupled RECs.
- Plot 34 is the time profile of the sampled signal received.
- the units of both axes of the graph are arbitrary.
- the scaling of the amplitude varies in the three graphs shown in Fig. 2. Namely the peak to peak (p.t.p.) amplitudes of the actual oscillations are significantly larger than the respective values of the received signals, whereas the amplitude of the transmitted pulses is significantly larger compared to the maximal p.t.p amplitude of the oscillations.
- the displacements in the amplitude values of the different time profiles shown are artificially introduced.
- the transmitted power per a single pulse, pulses' widths, the number of transmitted pulses within one session of measurements and the respective pulse repetition rates are programmable in accordance with a preferred embodiment of the present invention.
- an automatic gain control (AGC) or an automatic level control (ALC) as well as tuning of the pulses' width are automatically applied by means of the operating program installed in the system's processor.
- the pulse widths, repetition rates, and the number of pulses in a session are selected according to the method of the present invention such that the signal to noise ratio of the measured frequencies is promoted.
- Blocking is accomplished either by means of a dedicated electrical circuit that is synchronized with the transmitted pulses, or by programming the sampling and digitizing unit to delay the sampling process of a received signal by a predefined time interval. Typical blocking times are of a few dozens of microseconds, whereas typical pulse widths are within a few microseconds.
- the received signal of a pair of magnetically coupled RECs can be described by a monotonic wave whose frequency equals the arithmetic average of both respective resonance frequencies whereas its amplitude is modulated. In a case in which both RECs oscillate at the same amplitude the modulation frequency equals half of the difference in the resonance frequencies. Therefore by properly selecting the sampling rates as well as the ends of the time intervals along which a signal is sampled and further averaging the measured frequencies, a frequency of the received signal is determined.
- the frequencies of the RECs are derived from the values of such measured frequencies.
- the arithmetic average of the resonance frequencies of each REC of a pair of RECs is referred hereinafter as the resonance frequency of the pair.
- a transmitter capable for generating pulsed CW signals is in accordance with the present invention.
- the frequency of the CW generator is selected to be close to the resonance frequency of a pair of RECs.
- the selected pulse width is significantly larger compared to the respective cycle time according to an embodiment of the present invention.
- the receiver is similarly blocked in such case for a predefined time interval following the end of a transmitted pulse.
- the derivation of the resonance frequencies by means of such system is similar to the method described above.
- each of the RECs of an irradiated pair are forced to oscillate at the same frequency which equals the frequency of the transmitter. The level of these oscillations increases as the transmitter frequency approaches the resonance frequency of the respective REC.
- the level of the received signal reaches its maximal value at a frequency equal, or closely equal, to the resonance frequency of the respective pair. Therefore, by sweeping the frequency of a transmitted CW signal having a fixed pre-selected amplitude, within a predefined frequency band, and further detecting the frequency in which the received signals gets their maximal value, this frequency can be determined, as known.
- a REC of a system of the invention such as any common RLC circuit consists of inductor having a predefined inductance, a capacitor of a predefined capacity and a predefined ohmic resistance.
- Q factor quality factor
- the ohmic resistance of the wire is the only resistor employed.
- Typical Q factors of RECs of a system of the invention can reach and/or exceed the value of 150 close to their resonance frequencies.
- the inductors are designed according to a preferred embodiment of the present invention to have a predefined diameter in the range of 1 - 3 mm; a predefined length in the range of 5 - 15 mm and a core of ferrite onto which the electrical wire is coiled.
- An inductor of a REC of a system of the invention typically has a predefined number of windings, such that a predefined inductance is achieved, which is in the range of a few milli Henrys.
- the wire which is a common cooper wire typically utilized for manufacturing inductors, is preferably coiled on the surface of the ferrite core, as known, in layers each of which includes dozens of windings.
- the terminals of an inductor are electrically connected to the terminals of a common capacitor whose capacity is in the range of a number of hundreds of pF, but less than 2000 pF.
- a REC is wrapped or coated with an electrically insulating layer made of biocompatible material, such as parylene C.
- a REC is further coated with relatively thick cover layer providing for strengthening its mechanical structure and securing the REC from the in vivo chemical environment.
- an adhering material typically utilized in arthroplasty is utilized for such coating.
- Any glue normally utilized in osteotomy such as Simplex P (TM) , Speedset Radiopaque Bone Cement (TM) , Refobacin Plus Bone Cement (TM) , Biomet Plus Bone Cement (TM) , Orthoset 1 Radiopaque Bone Cement (TM) , is suitable as long as such coating when is cured provides for mechanically strengthening the structure of a REC and promotes its sustainability to the in vivo chemical and mechanical environment.
- TM is made of a biocompatible plastic resin such as polyurethane.
- the value of the mutual inductance associated with any of the RECs of a pair increases as their separation decreases.
- the mutual inductance reaches its extreme values for each separation distance at a collinear configuration.
- Each REC of a pair is respectively attached to a segment of a pair of bones or segments of bones whose relative displacements and/or rotations are to be monitored. Attaching according to a preferred embodiment of the present invention is accomplished such that the RECs' axes are not collinear but parallel.
- the axes of the RECs of an attached pair preferably point in opposite directions such that the values of their mutual inductance are maximized for this configuration.
- exemplary resonance frequency - distance profile 40 measured by employing pulsed transmissions according to a preferred embodiment of the present invention is shown.
- the resonance frequency of a pair of RECs decreases as their relative distance increases. Similarly the resonance frequency of a pair decreases as the angle between their axes increases while their separation remains fixed. Therefore by monitoring changes in the measured resonance frequency of a pair of RECs its RECs respectively attached to segment of a bone or bones, displacements and/or rotations of the respective segments of the bone or bones are determined.
- the resonance frequency of a pair of RECs monotonically decreases, as the distance between the respective segments of the bone or bones increases.
- the difference between extreme values of the resonance frequency of a pair of RECs measured along a predefined time interval increases as the amplitude of the rotational motion of the respective segments of bone or bones increases.
- a smaller distance between the RECs of a pair or lower amplitude of their relative rotations results in an increased resonance frequency and/or decreased difference between the extreme frequency values measured within a relatively short time.
- Attaching each of the RECs to a segment of bone is accomplished by means of any of the aforementioned adhering material or bones' glues.
- the RECs are introduced into conforming niches or bores drilled into and/or through the bone prior to their attaching.
- the cover of RECs is threaded such that the REC is screwable into a drilled bore disposed on the surface of a segment of bone.
- a segment of the surface of the cover layer is threaded and/or textured providing for its attaching into an inner surface of a drilled bore by pressing.
- the axes of different pairs are preferably such oriented that they are not mutually parallel, to thereby promote the sensitivity of detecting relative rotations.
- Pairs of RECs such as pair 50 and 52, of a system for monitoring in vivo displacements and/or rotations are respectively attached to two halves of a sternum. Such configuration provides for monitoring the healing of a sternum following for example an open chest surgery.
- Pair of RECs 60 provides for monitoring displacements and/or rotations of vertebra 62 relative to vertebra 64 in a spine.
- pair of RECs 70 provides for monitoring displacements and/or rotations of segment 72 relative to the bone of skull 74 following craniotomy.
- the relative displacements and/or rotations of segments of fractured or dissected bones, prostheses attached to a segment of bone or artificial joints can be monitored by means of a system of the invention.
- the progress of healing of bone trauma and/or dissection can be determined by monitoring the changes in the respective resonance frequency of a pair of RECs. In cases in which such changes do not exceed a respective threshold the respective segments of the bone or bones are regarded stationary thereby healing is determined according to the method of the present invention.
- a typical sampling rate of the received signal according to a preferred embodiment of the present invention is within a few dozens of hundreds Hz.
- the samples are digitized with a common 14 bits A/D converter.
- Most of the signal processing including filtering is accomplished by the operating software of the systems processor.
- the measured frequency is derived, such as by means of FFT or a filter matched to the resonance frequencies of the pairs, in cases of pulsed transmissions.
- An adaptive matched filtering such as by an adaptive neural network filter is suitable for measuring the resonance frequencies of pairs in cases of CW transmissions.
- a measured resonance frequency of pairs of RECs is averaged according to a preferred embodiment of the present invention over a predefined number of repeatedly measured frequencies within a first time interval.
- An exemplary first time interval includes samples having signal to noise ratios (SNR) exceeding a predefined threshold.
- a process of sampling the data includes the following steps: (a) signals are repeatedly sampled at a predefined sampling rate along a time interval which is significantly longer compared to a cycle time of the modulated amplitude of the received signals; (b) averaged values of SNR are derived for successive time intervals shorter compared to a cycle time of the modulated amplitude, these intervals are contained within the first time interval; (c) a region in time in which such averaged SNR gets its maximal value is selected; (d) FFT computation is carried out considering a predefined number of samples received along this selected time region; (e) a frequency bin whose output value is maximal including its adjacent bins are selected; (f) a frequency value is derived by averaging the frequencies related to these selected frequency bins, averaging is carried out considering the values of the output of a selected frequency bin.
- Such repeatedly measured frequencies as well as their averaged value associated with a specified pair of RECs are stored in a record associated with an identity of a patient in a database.
- Currently averaged frequency is compared to values of averaged frequencies related to this specific pair of RECs previously stored in the database.
- a deviation of the currently measured frequency off a respective stored frequency is determined.
- Cases in which the currently averaged frequencies are smaller compared to the respective averaged frequencies previously measured correspond to displacements in which the distance between the respective RECs is extended, and/or rotational movement by extended angles occurred.
- a notice to the operator is automatically displayed.
- an alert is automatically transmitted to the backward computer to which the system processor is linked and/or the responsible physician is similarly alerted in such cases.
- a laboratory experiment for demonstrating the functional behavior of the resonance frequency of a pair of RECs of a system according to a preferred embodiment of the present invention is hereby described with reference to Fig. 7.
- a pair of RECs whose relative distances and orientations are controlled were irradiated by trains of electromagnetic pulses.
- the RECs were disposed one aside the other, such that the angles between their axes as well as their relative distance could be varied.
- Plot 80 is a frequency (f) - distance (d) profile measured for a fixed orientation in which both RECs are parallelly disposed such that their mutual inductances are maximal for each distance.
- Plot 82 is a frequency - distance profile measured for a fixed orientation in which the angle between the axes is of 10°.
- Plot 84 represents a frequency - distance profile measured at an inclination angle of 20°.
- the frequency scale is measured in kHz.
- the distances were measured between the surfaces of the cover layers of both RECs in mm. Therefore the values presented are off a minimal value which is close to the length of the diameter of the RECs.
- a laboratory experiment demonstrating the stability and repeatability of the measurements of the respective resonance frequency of two pairs of RECs of a system according to a preferred embodiment of the present invention was conducted while monitoring displacements of one segment of bone relative to another.
- a sternum of a pig was longitudinally bisected.
- Two pairs of RECs symmetrically disposed close to the edges of the cut were attached unto niches drilled through each segment of the sternum by means of bond cement as described hereinabove.
- the pairs of RECs are placed along the sternum as describe hereinabove with reference to Fig. 4 to which reference is again made.
- the segments of the bone and the RECs were immersed in saline solution to mimic in vivo environment.
- the setup of the experiment provides for controlling the distances between both edges of the cut along the sternum. Electromagnetic CW radiation emitted by the transmitter of the system respectively excited oscillations in each of both pairs. Distinguishing between the different pairs was achieved by respectively positioning the antenna at a close proximity to each of the pairs.
- Plot 90 is a frequency - distance profile measured for the pair of RECs that were initially disposed closer to each other at a minimal distance of 4 mm.
- Plot 92 is a frequency - distance profile of the pair initially disposed at a minimal distance of 7 mm.
- the horizontal axis of the graph displays distances measured between the edges of both segments of sternum disposed along the cut.
- the differences in resonance frequencies respectively related to each pair being at the same distance separating between its RECs shown can be interpreted by deviations in the initial orientations as well as by differences in their inductances' values. The same results were obtained for measurements repeated a number of times within the same tolerances which are lower by far than the value of the threshold defining a stationary configuration corresponding to a "healed bone".
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Abstract
Système pour la surveillance de déplacements et/ou d'un mouvement rotatif d'objets in vivo. Le système comprend un ou plusieurs circuits électriques résonants (REC) couplés par liaison magnétique, un émetteur pour exciter les paires de REC afin de les faire osciller, un récepteur pour recevoir les signaux électromagnétiques émis par les REC oscillants, et un processeur pour déduire les fréquences associées aux signaux reçus. Chaque REC d'une paire est respectivement fixé à un objet in vivo, tel qu'un segment d'os. Un mouvement relatif en translation et/ou en rotation d'une paire de segments d'un ou plusieurs os entraîne une variation des fréquences de résonance des REC respectifs. La surveillance est réalisée par comparaison des fréquences de résonances actuellement mesurées à des fréquences préalablement stockées. Lorsque les variations des fréquences mesurées n'excèdent pas une valeur seuil prédéfinie, un état stationnaire est établi.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US82127006P | 2006-08-03 | 2006-08-03 | |
US60/821,270 | 2006-08-03 |
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WO2008015679A2 true WO2008015679A2 (fr) | 2008-02-07 |
WO2008015679A8 WO2008015679A8 (fr) | 2008-05-22 |
WO2008015679A3 WO2008015679A3 (fr) | 2009-04-23 |
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EP2268218A2 (fr) * | 2008-04-01 | 2011-01-05 | CardioMems, Inc. | Système et appareil pour évaluation in vivo de la position relative d'un implant |
US8777947B2 (en) | 2010-03-19 | 2014-07-15 | Smith & Nephew, Inc. | Telescoping IM nail and actuating mechanism |
US8896324B2 (en) | 2003-09-16 | 2014-11-25 | Cardiomems, Inc. | System, apparatus, and method for in-vivo assessment of relative position of an implant |
US9078563B2 (en) | 2005-06-21 | 2015-07-14 | St. Jude Medical Luxembourg Holdings II S.à.r.l. | Method of manufacturing implantable wireless sensor for in vivo pressure measurement |
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US9918742B2 (en) | 2011-05-16 | 2018-03-20 | Smith & Nephew, Inc. | Measuring skeletal distraction |
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US9265428B2 (en) | 2003-09-16 | 2016-02-23 | St. Jude Medical Luxembourg Holdings Ii S.A.R.L. (“Sjm Lux Ii”) | Implantable wireless sensor |
US9078563B2 (en) | 2005-06-21 | 2015-07-14 | St. Jude Medical Luxembourg Holdings II S.à.r.l. | Method of manufacturing implantable wireless sensor for in vivo pressure measurement |
US11672684B2 (en) | 2006-10-20 | 2023-06-13 | Nuvasive Specialized Orthopedics, Inc. | Adjustable implant and method of use |
US11234849B2 (en) | 2006-10-20 | 2022-02-01 | Nuvasive Specialized Orthopedics, Inc. | Adjustable implant and method of use |
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WO2008015679A3 (fr) | 2009-04-23 |
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