CN104799904A - System and method for identifying a landmark - Google Patents

System and method for identifying a landmark Download PDF

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Publication number
CN104799904A
CN104799904A CN201510252975.8A CN201510252975A CN104799904A CN 104799904 A CN104799904 A CN 104799904A CN 201510252975 A CN201510252975 A CN 201510252975A CN 104799904 A CN104799904 A CN 104799904A
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CN
China
Prior art keywords
sensor
implant
recognition device
marker recognition
labelling
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CN201510252975.8A
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Chinese (zh)
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CN104799904B (en
Inventor
J·K·雷恩斯
N·S·里基
G·E·奥斯丁
H·B·费伯
N·K·格鲁辛
T·施韦利
W·M·里奇
S·W·詹纳
C·C·赫奥蒂斯
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Smith and Nephew Inc
Original Assignee
Smith and Nephew Richards Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from PCT/US2008/055300 external-priority patent/WO2008106593A2/en
Application filed by Smith and Nephew Richards Inc filed Critical Smith and Nephew Richards Inc
Priority claimed from CN200880128908.3A external-priority patent/CN102014771B/en
Publication of CN104799904A publication Critical patent/CN104799904A/en
Application granted granted Critical
Publication of CN104799904B publication Critical patent/CN104799904B/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
    • A61B17/1707—Guides or aligning means for drills, mills, pins or wires using electromagnetic effects, e.g. with magnet and external sensors
    • 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
    • A61B5/061—Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body
    • A61B5/064—Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body using markers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
    • A61B17/1725—Guides or aligning means for drills, mills, pins or wires for applying transverse screws or pins through intramedullary nails or pins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/72—Intramedullary pins, nails or other devices
    • 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
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3954—Markers, e.g. radio-opaque or breast lesions markers magnetic, e.g. NMR or MRI
    • A61B2090/3958—Markers, e.g. radio-opaque or breast lesions markers magnetic, e.g. NMR or MRI emitting a signal
    • 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
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/397—Markers, e.g. radio-opaque or breast lesions markers electromagnetic other than visible, e.g. microwave

Abstract

A system (1010, 1110) for identifying a landmark is disclosed. The system includes a field generator (1016, 1116) for generating a magnetic field, an orthopaedic implant (1030, 1130) located within the magnetic field, the implant having at least one landmark (1028,1128), a removable probe (1029, 1129) with a first magnetic sensor (1026,1126), a landmark identifier (1016, 1116) with a second magnetic sensor (1020, 1120) and a processor (1012, 1112) for comparing sensor data from the first and second sensor and using the set distance to calculate the position of the landmark identifier relative to the at least one landmark. The system allows for blind targeting of one or more landmarks.

Description

For the system and method for identification marking
The application is divisional application, and the application number of original application is 200880128908.3, and the applying date is on October 28th, 2010, and denomination of invention is " system and method for identification marking ".
To the cross reference of related application
This application claims the rights and interests that the application number submitted on February 29th, 2008 is the pct international patent application of PCT/US2008/55300.The overall disclosure content of this application is cited in this as reference.
Relate to the federal research of patronage or the statement of exploitation
Inapplicable.
Annex
Inapplicable.
Technical field
Embodiments of the invention relate generally to rectificating surgery implant, and more particularly, embodiments of the invention relate to the blind labelling (blind landmark) identified on rectificating surgery implant.
Background technology
Interior (IM) fixed range of marrow of long bone fracture has been widened in the use of interlocking hip nail greatly.The locking of intramedullary pin makes above-mentioned structure longitudinally more stable and stopped the rotation of nail in bone.Typical Intramedullary nailing surgical operation relates to and combines fixture, x-ray imaging device and artificial visually examine's device to locate and to get out distal screw holes.
In this surgical procedures, intramedullary pin is hammered in the conduit of fractured long bones so that by the end winding support of fracture together.Under normal circumstances, that first implements is near-end locking and usually uses fixture to implement the locking of described near-end.But, follow closely the distortion produced in the process in insertion marrow and can cause for distal screw, occur the inaccurate situation of fixture.Main difficulty is the location of carry out far-end locking screw and drilling tool is alignd to get out the step of distal screw holes, this is because this is the challenging step of also most the most consuming time in whole implantation process.Therefore, two main causes cannot implementing far-end locking are misorentations of the inaccurate and drilling tool of the inlet point on bone.If mistake appears in the arbitrary factor in these two factors, then drilling tool can not pass nail.
Inlet point inaccurate also make the rounded ends of drill bit usually occur the problem of skidding is more complicated, and thus make to be difficult to arrange hole adjacent with one that is comparatively early formed another hole.Inaccurate far-end locking can cause occurring prematurely damaging, and makes the nail through nail occur fracture, makes screw occur fracture or make the drill bit in bone occur fracture.
Manual technique is the most general also the most received technology for observing distal screw holes and occupies superiority in orthopedics's industry.Most remote target location technology all can use lining (cylindrical sleeve) to guide drilling tool.This guide bushing is alignd and to hold it in the mechanism of appropriate position different.In some cases, surgeon uses half sleeve (lining longitudinally cut in half) or complete sleeve to help steady drill bit in drilling process.Under any circumstance, surgeon will implement incision to patient and plant drilling tool by this otch.Manual technique mainly employs x-ray imaging device and the mechanical clamp of radiography based on surgical manual technique.
The another kind of method that spike realizes this object is under the help in C-arm portion, use so-called " standard round (perfect circle) " technology.In this case, technical staff carries out orientation to patient and C-arm portion, thus makes when adopting this implant of fluoroscopic observation, and the hole that screw will pass presents round shape.If C-arm portion is also not orthogonal to this hole, then it will present ellipse or even not exist.
In the art, still need to provide a kind of system and method for carrying out target localization to the labelling of medical implant.Further, in the art, still need accurately to locate far-end locking screw and need drilling tool is alignd to get out distal screw holes.
Summary of the invention
The invention provides a kind of system for identification marking, described system comprises: for generation of the field generator in magnetic field; Be positioned at the rectificating surgery implant in described magnetic field, described rectificating surgery implant has at least one labelling; There is dismountable detector of the first magnetic sensor separated with at least one labelling described; There is the marker recognition device of the second magnetic sensor; And processor, described processor is for the sensing data that contrasts from described first sensor and described second sensor and use described setpoint distance to calculate the position of described marker recognition device relative at least one labelling described.
Present invention also offers a kind of system for identification marking, described system comprises: for generation of the field generator in magnetic field; Be positioned at the rectificating surgery implant in described magnetic field, described rectificating surgery implant has at least one labelling and longitudinal groove, and described longitudinal groove has proximal part and distal portions; First magnetic sensor, described first magnetic sensor to be installed in the described distal portion office of described longitudinal groove on described rectificating surgery implant and to separate setpoint distance with at least one labelling described; There is the marker recognition device of the second magnetic sensor; And processor, described processor is for the sensing data that contrasts from described first sensor and described second sensor and use described setpoint distance to calculate the position of described marker recognition device relative at least one labelling described.
According to some embodiments, described labelling is selected from the cohort comprising structure, space, projection, passage, brake, flange, groove, component, separator, step, hole, hole, cavity, recess, conduit, gap, recess, aperture, path, otch, eyelet or slit.
According to some embodiments, described rectificating surgery implant is intramedullary pin.
According to some embodiments, described rectificating surgery implant has outer surface, the inner surface forming intubate and therebetween wall portion, and described first magnetic sensor is installed in described wall portion.
According to some embodiments, described rectificating surgery implant comprises recess further and described first sensor is arranged in described recess.
According to some embodiments, described rectificating surgery implant comprises lid further.
According to some embodiments, described rectificating surgery implant comprises the second opening being suitable for receiving lid further.
According to some embodiments, described rectificating surgery implant comprises the recess of circumference further.
According to some embodiments, described system comprises the lead-in wire being connected to the first magnetic sensor.
According to some embodiments, described system comprises the insertion handle be detachably attached on described rectificating surgery implant.
According to some embodiments, described system comprises the watch-dog being electrically connected to described processor.
According to some embodiments, described system comprises the dismountable lead-in wire being connected to described first sensor.
According to some embodiments, described longitudinal groove arranges along the outer surface of described implant.
According to some embodiments, described rectificating surgery implant comprises intubate further, and described longitudinal groove is usually adjacent with described intubate.
According to some embodiments, described marker recognition device comprises drill sleeve.
According to some embodiments, described marker recognition device comprises serrated tip further.
According to some embodiments, described marker recognition device comprises pipeline further.
According to some embodiments, described marker recognition device comprises mark sensor (marking sensor) further.
According to some embodiments, described marker recognition device comprises handle further.
According to some embodiments, described processor provides feedback information for user.
The invention provides a kind of system for identification marking, described system comprises: for generation of the field generator in magnetic field; Be positioned at the rectificating surgery implant in described magnetic field, described rectificating surgery implant has at least one labelling; Magnet, described magnet to be installed on described rectificating surgery implant and to separate setpoint distance with at least one labelling described; There is the marker recognition device of magnetic sensor; And processor, described processor is for the sensing data that contrasts from described magnetic sensor and use described setpoint distance to calculate the position of described marker recognition device relative at least one labelling described.
The invention provides a kind of method for identification marking, described method comprises: provide rectificating surgery implant assembly, described rectangle implant assembly has rectificating surgery implant and dismountable lead-in wire, described rectangle implant has longitudinal groove, described dismountable lead-in wire is attached with magnetic transducing and is positioned at described longitudinal groove, described rectificating surgery implant has proximal part, distal portions and is positioned at least one labelling on described distal portions; By in described rectificating surgery implant assembly implantation; First will pierce through element is arranged in described proximal part; Usage flag evaluator identifies at least one labelling described; After first piercing through element and being arranged in described proximal part, be arranged on be arranged at least one labelling described in described distal portions by piercing through element; And remove described dismountable lead-in wire.
The invention provides a kind of patterned user interface, described patterned user interface comprises: the Part I representing the drilling degree of depth relative to implant; And Part II, described Part II represents the marker recognition device position relative to labelling, and described labelling is positioned in described implant.
The present invention has the multiple advantages being better than existing apparatus and technology.First, the present invention can run independent of fluoroscopy and make to carry out target localization without the need to arranging X-ray apparatus to piercing through element, which reduces the degree that user and patient are exposed to radiation.Secondly, the invention enables user can before locking anti-drive end lock drive end.In other words, in certain embodiments, the present invention does not need use implant intubate and make to carry out near-end locking before carrying out far-end locking.
Below in conjunction with accompanying drawing, the structure of further aspect of the present invention, aspect and advantage and multiple embodiment of the present invention and operation are described in detail.
Accompanying drawing explanation
Accompanying drawing is included in this manual and constitutes the part of this description.There is shown embodiments of the invention, and accompanying drawing and description one are below used from and explain principle of the present invention.In the accompanying drawings:
Fig. 1 shows the first embodiment of the system for identification marking;
Fig. 2 is the sectional view of the first embodiment of rectificating surgery implant assembly;
Fig. 3 shows the first embodiment of sensor;
Fig. 4 shows the second embodiment of sensor;
Fig. 5 shows the sensor shown in Fig. 4;
Fig. 6 shows the second embodiment of rectificating surgery implant assembly;
Fig. 7 is the front view of dismountable lead-in wire;
Fig. 8 is the top view of the assembly of rectificating surgery implant shown in Fig. 6;
Fig. 9 shows marker recognition device;
Figure 10 shows the sectional view of the point contact in the first embodiment;
Figure 11 shows the sectional view of the point contact in the second embodiment;
Figure 12 A shows the sectional view of the arrangements of electric connection of cockle;
Figure 12 B shows the schematic diagram of the arrangements of electric connection in the first optional enforcement profit;
Figure 12 C shows the schematic side view of arrangements of electric connection shown in Figure 12 B;
Figure 12 D shows the schematic diagram of the arrangements of electric connection in the second optional enforcement profit;
Figure 13 A shows and implements in profit for making rectificating surgery implant and the fragmentary perspective view inserting other alternative mechanisms that handle aligns first;
Figure 13 B shows the fragmentary perspective view for other alternative mechanisms of making rectificating surgery implant align with arrangements of electric connection in the second optional enforcement profit;
Figure 14 shows the connection of inserting handle and rectificating surgery implant;
Figure 15 shows the second embodiment of the system for identification marking;
Figure 16 shows the schematic diagram of visual field choice criteria;
Figure 17 shows the flow chart that step is selected in the visual field;
Figure 18 shows the schematic diagram of the first optional method that marker recognition device is alignd;
Figure 19 shows the schematic diagram of the second optional method that marker recognition device is alignd;
Figure 20 shows the exemplary view of watch-dog;
Figure 21 shows the another kind of embodiment of marker recognition device;
Figure 22 shows the first embodiment inserting handle;
Figure 23 shows the 3rd embodiment of the system for identification marking;
Figure 24 shows the second embodiment inserting handle;
Figure 25 shows the 3rd embodiment of the system for identification marking;
Figure 26 shows the detailed viewgraph of cross-section of intramedullary pin;
Figure 27 shows a packaging embodiment;
Figure 28 shows the method this system being connected to network;
Figure 29 shows the 4th embodiment of the system for identification marking;
Figure 30 shows the first pass figure for using this system;
Figure 31 shows the second flow chart for using this system;
Figure 32 shows the second embodiment for following the trail of the drilling degree of depth;
Figure 33 A and 33B shows the 3rd embodiment for following the trail of the drilling degree of depth;
Figure 34 shows the 4th embodiment for following the trail of the drilling degree of depth;
Figure 35 shows insertion handle;
Figure 36 shows the top perspective of scalable backstop;
Figure 37 shows the bottom perspective view of the backstop of scalable shown in Figure 36; With
Figure 38 shows the 3rd flow chart for system calibration.
Detailed description of the invention
See accompanying drawing, Reference numeral similar in figure represents similar element, and Fig. 1 shows the first embodiment of the system 10 for identification marking.System 10 comprises processor 12, magnetic field generator 16, marker recognition device 18 and rectificating surgery implant assembly 28.In certain embodiments, system 10 comprises the watch-dog 14 being electrically connected to processor 12 and the insertion handle 40 be detachably attached on rectificating surgery implant assembly 28 further.Processor 12 is illustrated as desktop computer in FIG, but equally also can use the accountant of other type.As an example, processor 12 can be desktop PC, laptop computer, PDA(Personal Digital Assistant), mobile handsets or special purpose device.In the embodiment shown in the drawings, magnetic field generator is the device that can be provided by following supplier: 107 Catamount Drive, the Ascension Technology Corporation of Milton Vermont, U.S.A.; 103 Randall Drive, the Northern Digital Inc. of Waterloo, Ontario, Canada; Or 40 Hercules Drive, the Polhemus of Colchester Vermont, U.S.A..Certainly, also other generator can be used.As an example, field generator 16 can provide pulse direct current electromagnetic field or ac magnetic field.In certain embodiments, system 10 comprises the control unit (not shown) being connected to magnetic field generator 16 further.Control unit controlling filed generator, receive the signal from small-sized movable inductance sensor and communicate with processor 12, this is realized by wired or wireless mode.In certain embodiments, control unit is included in processor 12 by hardware or software.
System 10 is magnetic position tracing systems.For exemplifying object, system 10 comprises magnetic field generator 16, and described magnetic field generator comprises the electromagnetic inductance coil be implemented in any suitably arranged, and this coil is used as space magnetic infrastructural frame (i.e. X, Y, Z).System 10 comprises small-sized movable inductance sensor further, and described sensor is attached on tracked object.Be appreciated that other modification is also be easy to received.The position of small-sized movable inductance sensor and angular orientation depend on the magnetic coupling that this sensor carries out with the place, source produced by magnetic field generator 16.
It should be noted that: magnetic field generator 16 creates a series of, or one group, different space magnetic field shapes or distribution, be six herein, and each space magnetic field shape or distribution are sensed by small-sized movable inductance sensor.Each series makes small-sized movable inductance sensor to produce a series of signal.Position and/or the orientation of determining small-sized movable inductance sensor are made it possible to the process of this series of signal, and therefore, it is possible to determine it is provided with the position of object relative to magnetic coordinate infrastructural frame of this small-sized movable inductance sensor, the relation of this magnetic coordinate infrastructural frame and magnetic field generator 16 is fixing.The data that processor 12 or control unit use the frame of reference to unify to sense are to form transformation matrix, and described transformation matrix comprises position and orientation information.
Marker recognition device 18 is for labelling, and such as, labelling on rectificating surgery implant assembly 28, carries out target localization.Marker recognition device 18 comprises one or more small-sized movable inductance sensor.In the embodiment shown in the drawings, marker recognition device 18 has the second sensor 20.Marker recognition device 18 can be any amount of device.As an example, marker recognition device 18 can be drilling tool guiding device, drill sleeve, drilling tool, brill nose (drill nose), drilling pipe (drill barrel), drill chuck (drill chuck) or retaining element.In the embodiment shown in fig. 1, marker recognition device 18 is drill sleeve.In certain embodiments, what described marker recognition device can comprise in serrated tip 22, pipeline 24 and handle 26 is one or more.Pipeline 24 also can be referred to as lining, cylinder, guiding device or drilling tool/screw and lay guiding device.In the embodiment shown, under the second sensor 20 is arranged on certain orientation relative to the axis of pipeline 24, described pipeline can receive drilling tool.Sensor 20 makes the position of this pipeline and orientation can be located in space in six sizes (three translation sizes and three Angular Dimensions) relative to another sensor in magnetic field generator 16 or system relative to this skew that pipeline 24 is formed.In certain embodiments, may need to calibrate processor 12 to regulate the offset distance of the second sensor 20.In certain embodiments, marker recognition device 18 and field generator 16 can be combined into single parts.Such as, field generator 16 can be included in handle 26.
Rectificating surgery implant assembly 28 comprises implant 30 and one or more small-sized movable inductance sensor.In the embodiment shown, rectificating surgery implant assembly 28 has first sensor 23.In the embodiment shown in fig. 1, implant 30 exists with the form of intramedullary pin, but also can use the implant of other type.As an example, implant can be intramedullary pin, hone lamella, hip prosthesis or knee-joint prosthesis.First sensor 32 is configured to certain orientation relative to the one or more labellings in implant 30 and is arranged on pre-position.As an example, described labelling can be structure, space, projection, passage, brake, flange, groove, component, separator, step, hole, hole, cavity, recess, conduit, gap, recess, aperture, path, otch, eyelet or slit.In the embodiment shown in fig. 1, labelling is pierced holes 31.First sensor 32 makes the position of this labelling can be located in space in six sizes (three translation sizes and three Angular Dimensions) relative to another sensor in magnetic field generator 16 or system relative to this skew that labelling is formed, and another sensor described is such as the second sensor.In certain embodiments, may need to calibrate to regulate the offset distance of first sensor 32 processor 12.
First sensor 32 and the second sensor 20 are connected to processor 12.This realizes by wired or wireless mode.First sensor 32 and the second sensor 20 can be the sensors with six-freedom degree, described sensor be configured so that along be commonly referred to as three translation shafts of X, Y and Z and be commonly referred to as pitching (pitch), position that three angular orientation of side-sway (yaw) and rolling (roll) (i.e. attitude, namely around the anglec of rotation of X, Y and Z axis) describe each sensor.By by sensor localization in these infrastructural frames, and know position and the orientation of each sensor, marker recognition device 18 can be located relative to the labelling in implant 30.In a particular embodiment, the information carrying out sensor makes surgeon can plan the surgical approach for being fixed and drilling tool is suitably alignd with fixing blind hole.In the embodiment shown, sensor 32,20 is the sensors with six-freedom degree provided by following supplier: 107 Catamount Drive, the Ascension Technology Corporation of Milton Vermont, U.S.A.; 103 Randall Drive, the Northern Digital Inc. of Waterloo, Ontario, Canada; Or 40 Hercules Drive, the Polhemus of Colchester Vermont, U.S.A..Certainly, also other sensor can be used.
First sensor 32 can be attached in implant 30.Such as, first sensor 32 can be attached on outer surface 37.In the embodiment shown in fig. 1, implant 30 comprises groove 34 and recess 36(the best as shown in Figure 2 further).Groove 34 and recess 36 are arranged in the wall portion of implant 30.In the embodiment shown, first sensor 32 to be intended to be attached in implant 30 and to be all installed in patient body during the service life of implant 30.Further, in certain embodiments, rectificating surgery implant assembly 28 comprises lid 38 to cover recess 36 and/or groove 34.Lid 38 can flush substantially with the outer surface 37 of implant 30.Therefore, in certain embodiments, implant 30 comprises second opening 39(the best as shown in Figure 2) to receive lid 38.
It is upper to realize communication and power supply that first sensor 32 can be tied to lead-in wire.Lead-in wire and sensor can be fixed in implant 30.Lead-in wire 50 is used to first sensor 32 to be connected to processor 12 or control unit.Lead-in wire 50 can be made up of biocompatible metal wire.As an example, lead-in wire 50 can by Fort Wayne Metals Research Products Corp., and 9609 Indianapolis Road, the DFT metal wire that Fort Wayne, Indiana 46809 obtains is made.DFT is the registered trade mark of Fort Wayne Metals Research Products Corp..First adapter 52 can be used for laying lead-in wire 50 relative to implant 30.Second adapter 54 can be used for lead-in wire 50 to be connected to another device, as processor 12 or insertion handle 40.
Multiple high rigid binder or polymer can be used to be fixed in recess 36 by first sensor 32, and described multiple high rigid binder comprises epoxy resin, polyurethane, polymethyl methacrylate, polyether-ether-ketone, the binding agent by UV solidification, silicone and other cyanoacrylate of medical grade.As an example, can use by Epoxy Technology, 14 Fortune Drive, the EPO-TEK 301 that Billerica, Massachusetts 01821 provides.Lead-in wire 50 can be fixed in groove in a similar manner.The fixing means of these types can not have a negative impact to the performance of electric component.Lid 38 can be placed in subsequently in implant 30 and by place for described lid welding.Such as, described lid is soldered in implant by laser weld mode.
Watch-dog 14 can be configured so that the position and the orientation that demonstrate first sensor 32 and the second sensor 20, thus makes to provide two sensors position relative to each other and orientation by this surgeon of being shown as.Position data is sent to user interface by wired mode or wireless mode by processor 12, and described user interface can demonstrate the relative position between the implant on marker recognition device and watch-dog to graphically.On this watch-dog 14, the image of display can be configured to certain orientation relative to marker recognition device, thus user interface can be displayed by surgeon and as the extension of marker recognition device.This user interface also can be configured to certain orientation, thus makes surgeon can observe this watch-dog while observation surgical operation visual field.
Insert handle 40 to can be used for rectificating surgery implant assembly 28 being installed and also can be used for by the lead-in wire of certain route guidance from first sensor 32.Such as, inserting handle 40 can by the communication lead of certain route guidance between implant 30 and processor 12 and power supply lead wire.
In the embodiment shown in fig. 1, marker recognition device 18 and insertion handle 40 comprise the communication module 21,25 for wirelessly data to be sent to processor 12 from sensor 20,32 respectively, but one of ordinary skill in the art are appreciated that and can utilize other method, as by wired mode, realize transmitting.In the embodiment shown, the second adapter 54 inserts in communication module 25.Another kind of optional manner is, and it is just as described in greater detail belowly such, implant 30 and insertion handle 40 can have the Electical connector matched, when assembling parts, the described Electical connector matched defines connection, thus makes first sensor 32 be connected to communication module 25.
In certain embodiments, implant 30 can comprise telecommunication circuit and the antenna for realizing radio communication.Power supply for first sensor 32 and/or telecommunication circuit can be positioned in insertion handle 40.Such as, accumulator can be placed in and insert in handle 40, electrical power to be sent to first sensor 32 and/or other electronic device.Another kind of optional manner is, telecommunication circuit, antenna and accumulator can be positioned at inserts handle 40, and each parts in these parts can be tied on first sensor 32.In another embodiment, implant 30 can comprise coil to provide electrical power in inductance mode for telecommunication circuit and to realize the data communication carried out from first sensor 32.Power supply can be simplex power mode can be maybe bimodulus AC/DC.
In use, rectificating surgery implant assembly 28 is installed in patient body.Such as, when carrying out inside and being fixing, intramedullary pin is placed in marrow inner catheter.Optional manner is, user can use and pierce through element, as screw, first to lock the near-end of intramedullary pin.Operator uses target locating set 18 and first sensor 32 so that identification marking 31.Such as, when carrying out Intramedullary nailing, surgeon uses target locating set 18 to identify and drill through this hole to lay pierce through element to piercing through blind hole.
Fig. 2 further illustrates the implant 30 shown in Fig. 1.Implant 30 comprises first sensor 32, longitudinal groove 34, recess 36, lid 38 and the second opening 39.As an example, cover 38 and can comprise gold or titanium foil sheet.In certain embodiments, implant 30 comprises inner surface 35, and described inner surface defines intubate 33.Implant 30 comprises outer surface 37.
Fig. 3 shows the first embodiment of first sensor 32.First sensor 32 comprises two coils, described two coil placements intersected with each other and have angle α.
Fig. 4 and Fig. 5 shows the second embodiment of first sensor 32.First sensor comprises usually two orthogonal coils to set up orientation and position on six-freedom degree.First coil can have the orientation of the length along implant 30.Second coil can be configured to the orientation of the circumference being wound on implant, and described winding such as realizes in the trench, or this second coil can have the orientation of the radius along implant 30.In addition, although preferably make coil perpendicular to one another, also other orientation can be used, but mathematically may be more complicated.Further, coil can be configured to the orientation of spiral around implant 30.This orientation can allow two coils to be placed perpendicular to each other, and two coils be not only placed along the length of implant but also along the circumference of implant 30.
Fig. 6-Fig. 8 shows the second embodiment of rectificating surgery implant assembly 60.Rectificating surgery implant assembly 60 comprises implant 30.In the embodiment illustrated in fig. 6, implant 30 comprises the labelling existed with the form of pierced holes 31.Implant 30 comprises longitudinal internal groove 66 and dismountable lead-in wire 64.In the embodiment shown in fig. 8, the diameter of longitudinal groove 66 is as shown in the figure vertical with intubate 33; But in other embodiments, the diameter of longitudinal internal groove is comprised between outer surface 37 and inner surface 35.Dismountable lead-in wire 64 comprises the first sensor 32 being positioned at its distal portions 65 place.This first sensor 32 is known relative to the skew that labelling 31 is formed.Implant shown in Fig. 6-Fig. 8 comprises biocompatible material, and can be metal alloy or polymer.Longitudinal groove 66 is arranged on appropriate position by mach mode or molded and shaped mode.
In use, the implant 30 with dismountable lead-in wire is installed in patient body.Such as, when carrying out inside and being fixing, intramedullary pin is placed in marrow inner catheter.Alternatively, user can use and pierce through element, as screw, so that the near-end of first locking of intramedullary nails.Due to the position of longitudinal groove 66, therefore dismountable lead-in wire 64 produces interference to the near-end of first locking of intramedullary nails.Operator uses target locating set 18 and first sensor 32 so that identification marking 31.Such as, for carrying out the situation of Intramedullary nailing, surgeon uses target locating set 18 so that identification is pierced through blind hole and drilled through this hole so that element is pierced through in placement.After implant 30 is fixed, operator removes this dismountable lead-in wire 64 and is abandoned.
Fig. 9 further illustrates a specific embodiment of marker recognition device 18 as shown in Figure 1.In this particular example, described marker recognition device 18 comprises sensor 20, serrated tip 22, pipeline 24 and handle 26.Drilling tool 90 has mark 92, and described mark and mark sensor 19 interact, and described mark sensor is adjacent with pipeline 24.The similarity of this interaction and a pair digital measurement slide calliper rule is: the position identified between 92 and sensor 19 is equal to certain distance.This distance can be utilized to determine that drilling tool pierces the degree of depth in bone and finally determines the length of the nail be inserted in the hole that gets out.Only when sensor 92 and 19 each other tight adjacent time, namely only when drilling tool 90 be positioned at pipeline 24 inner time, just can obtain range reading or drilling degree of depth reading.Be that on January 13rd, 2004 licenses to the U.S. Patent No. 6 of Sasaki etc., 675,491 and license to the U.S. Patent No. 7,253 of Me etc. on August 7th, 2007, describe typical measuring device in 611, each described patent is cited in this as reference.In the embodiment shown, mark sensor 19 is connected to communication module 21.Another kind of optional manner is that mark sensor 19 is connected to processor 12 by wired mode.In fig .9, communication module 21 comprises the 3rd sensor 23 for being electrically connected to processor 12.Other embodiment of marker recognition device has been shown in Figure 32-34.
Figure 10-Figure 12 shows for implant 30 being electrically connected to the typical method inserting handle 40, and described implant and insertion handle have corresponding Electical connector.In Fig. 10, biasing element 72 makes contact device 70 be biased towards insertion handle 40.In fig. 11, implant 30 has resilient electrical contact device 74.In fig. 12, the metal wire extended between lead-in wire 50 with another parts is together with joint 76 cockle.In one approach, metal wire exempts from tear (torn free) and separated at joint 76 after having installed rectificating surgery implant assembly 28.In another method, after rectificating surgery implant assembly 28 has been installed, above joint 76, cut described metal wire.In Figure 12 B and 12C, one or more pad 57 is soldered together thus wire harness 55 is connected to sensor by two pieces of flexed plates 53.Wire harness 55 can be installed to and inserts on handle 40 or be installed in the intubate of insertion handle 40.In the illustrated embodiment, four pads 57 are soldered together.Lock tabs 59 is sandwiched in implant 30 and inserts between handle 40, thus tolerance inserts relevant wearing and tearing and stretching to implant.Be removed once insert handle, wire harness 55 can be pulled thus make to pull out the inconsistent material of all biologies thereupon.In fig. 12d, ring 61,63 are connected in the fabrication process.After the implants, by pulling the metal wire 67 of cover, ring 61,63 are all removed.
Referring now to Figure 13 A and 13B, implant 30 and/or insertion handle 40 can comprise one or more alignment feature 44 and recess with matching 80, or can comprise alignment pin 46 and hole with matching 82.Insert handle can be configured to align with the upper surface of implant.In one embodiment, inserting handle can have keyway, and described keyway is configured to match with the slit be positioned in implant.Other alignment guide can be used.In addition, guiding device can have electric connector, and described electric connector is configured to match with the electric connector in implant.Connecting device between guiding device and implant can be spring-loaded device, to guarantee to realize electrical contact between electrical.In order to avoid short circuit appears in the connecting device between guiding device and implant, insulated maintaining can be carried out to electric connector.As another example insertion handle being electrically connected to implant, electric connector can comprise post and slip ring.Ring can be positioned in implant, and post is positioned on insertion handle.This post is biased so that and loop contacts.In such an embodiment, insert handle not to be fixed relative to the angle position of implant axis.This makes no matter have what kind of angle position, inserts handle and all can be located relative to implant.
In another embodiment shown in Figure 13 B, implant 30 and/or insertion handle 40 can comprise one or more alignment pin 47 and hole with matching 83.Alignment pin 47 can be the needle-valve point pin being designed to realize single joint, and when being removed, the pin retained part of implant removes the inconsistent material of all biologies thereupon.
Any electric connector mentioned above can comprise the memory storage (not shown) of the shift value for storage sensors calibration.
Referring now to Figure 14, implant 30 and insertion handle 40 can be made into certain size, even if thus make, when assembling parts or coordinating, still can obtain the space for this first adapter 52.
As an example, the system for identification marking can be used to carry out target localization to the screw blind hole of implanted intramedullary pin.In the implanted patient body of this intramedullary pin.Electromagnetic field generator is activated.Processor receives from the signal of the sensor be installed on intramedullary pin and the signal from the sensor be installed on marker recognition device, and described marker recognition device is such as drill sleeve.The computer program run on a processor uses the information of at least two sensors and graphically demonstrates the relative position of these at least two sensors on a monitor.It is in place that surgeon uses the feedback provided by processor that marker recognition device is moved.When marker recognition device is positioned at appropriate position, surgeon drills through skeleton and intramedullary pin to form screw hole.In certain embodiments, processor can provide to by the relevant feedback of the degree of depth in hole that gets out.Surgeon can make screw pass this by the hole that gets out to carry out attached solid to the blind hole of intramedullary pin subsequently.
Figure 15 shows the second embodiment of the system 110 for identification marking.System 110 comprises processor 112, marker recognition device 118 and rectificating surgery implant assembly 128.In certain embodiments, system 110 comprises watch-dog 114 further and inserts handle 140.
Marker recognition device 118 is for carrying out target localization to labelling.Marker recognition device 118 comprises the second sensor 120.In embodiment as shown in figure 15, marker recognition device 118 is the drill sleeve with serrated tip 122, pipeline 124 and handle 126.In the embodiment shown, under the second sensor 120 is arranged on certain orientation relative to the axis of pipeline, described pipeline can receive drilling tool.Sensor makes the position of this pipeline can be located in space in six sizes (three translation sizes and three Angular Dimensions) relative to another sensor in conveyer or system relative to this skew that pipeline is formed.In certain embodiments, may need to calibrate processor to regulate the offset distance of the second sensor 20.
Rectificating surgery implant assembly 128 comprises implant 130 and magnet 132.This magnet can be permanent magnet or electromagnet.Magnet 132 is configured to certain orientation relative to the labelling in implant 130 and is positioned at pre-position.Magnet makes the position of this labelling can be located in space in six sizes (three translation sizes and three Angular Dimensions) relative to another sensor in conveyer or system relative to this skew that labelling is formed, and another sensor described is such as the second sensor.In certain embodiments, may need to calibrate to regulate the offset distance of magnet 132 processor 12.In the embodiment shown in fig. 1, implant 130 comprises recess 136 and lid 138 further.For the situation of electromagnet, lead-in wire 150 is connected to magnet 132 and is comprised in groove 134.
As an example, the system for identification marking can be used to carry out target localization to the screw blind hole of implanted intramedullary pin.In the implanted patient body of this intramedullary pin.Processor receives the signal from the sensor be installed on marker recognition device, and described marker recognition device is such as drill sleeve.The computer run on a processor uses the information of sensor and graphically demonstrates the relative position of this sensor relative to this magnet on a monitor.It is in place that surgeon uses the feedback provided by processor that marker recognition device is moved.When marker recognition device is positioned at appropriate position, surgeon drills through skeleton and intramedullary pin to form screw hole.In certain embodiments, processor can provide to by the relevant feedback of the degree of depth in hole that gets out.Surgeon can make screw pass this by the hole that gets out to carry out attached solid to the blind hole of intramedullary pin subsequently.
Figure 16 shows a kind of for selecting the method in the visual field corresponding with marker recognition device position.In certain embodiments, the position of marker recognition device relative to implant is depended in the display visual field on a monitor.The diameter of implant is divided into multiple sector or field domain.In embodiment as shown in figure 16, this diameter is divided into three field domains: (A) 135 degree to 225 degree; (B) 0 degree to 135 degree; (C) 225 degree to 360 degree.This initial visual field based on be the orientation of marker recognition device relative to implant.When user makes marker recognition device shift to implant or move away from implant, watch-dog demonstrates zooming in or out of region on selected field domain.
Figure 17 is for selecting the visual field and showing the flow chart of a labelling.This process can constantly repeat for multiple labelling.This processor 12 uses transformation matrix in following process steps.In step 200, based on the position calculation marker recognition device of related sensor relative to the position of implant, and the labelling closest to marker recognition device is selected to display it.Limit the overall visual field in step 210, this visual field shows the whole implant under selected labelling is arranged on certain orientation so that when suitably observing.The overall situation visual field is similar with the situation of to observe implant in position spaced apart.In a step 220, determine whether that multiple labelling has identical orientation.If answer is yes, then in step 230, processor calculate which labelling and marker recognition device position the most close to and select this labelling to observe.If answer is no, then limits local field of view in step 240 and make this visual field centered by selection marquee.Local field of view is similar with the situation of to observe this implant in close together position.In certain embodiments, when limiting local field of view, this marker recognition device hiding may be wished.In step 250,260 and 270, processor 12 identifies the distance from marker recognition device to this labelling, and hides according to made above-mentioned judgement or present this marker recognition device.In step 250, marker recognition device is calculated to the distance of this labelling and the variable T of the distance D this calculated and setting the overall situationand T locallycompare.If D is greater than T the overall situation, then the overall visual field is selected in step 260 and processor advances to step 285.If D is less than T locally, then select local field of view in step 270 and make this visual field be labeled as center with this.Subsequently, processor advances to step 275.In optional step 275, marker recognition device is hidden.Another kind of mode is, in step 280, and the position of camera in the middle of calculating based on distance D, thus make it possible to the transition smoothing to local field of view from the overall visual field.In step 285, marker recognition device is presented out.In step 290, the scene with selected position of camera is provided.
Figure 18 schematically shows the first optional method that marker recognition device is alignd.Can use the computer program that runs on a processor obtain described in the information of at least two sensors and the relative position (this second sensor is relative to the relative position of this first sensor) of at least two sensors described in display on a monitor to graphically.This makes user can use laying of this System guides marker recognition device.When drilling goes out intramedullary pin blind hole, this System guides user carries out laying of drill sleeve and suitably drills through this hole in this intramedullary pin subsequently.Patterned user interface can comprise the alignment guide mark for each degree of freedom provides.MIN alignment level can be set, thus make surgeon continue to carry out orientation to marker recognition device, until each degree of freedom meets MIN alignment level, thus placement markers evaluator effectively.Example shown in Figure 18 gives such a case, wherein meets required MIN tracking lay along laying of Y-direction.But other translation freedoms or rotary freedom all do not meet this MIN demand.Although show tracking amplitude in the mode of bar diagram in figure, other graphical representations mode, such as color coding also can be used.
Figure 19 schematically shows the second optional method that marker recognition device is alignd.In this embodiment, use multiple LED can be placed on marker recognition device to the graphic interface that drilling tool positions, described marker recognition device is such as drill sleeve.By using LED to carry out track tracking to drilling tool, surgeon can make drilling tool align with fixing blind hole.In addition, this track also can use secondary display to be system increase more information.Such as, in order to affect the amplitude of accommodation, this track can comprise makes LED glimmer, thus makes the flicker needs adjustment by a larger margin of high frequency, and low frequency flicker then can need adjustment more by a small margin.Similarly, color can increase the information relevant to the adjustment carried out to realize aliging.
Figure 20 shows the exemplary view of watch-dog.Part I 500 shows the drilling distance of carrying out on every side of implant.This makes user can understand the drilling degree of depth better and sends to user the alarm when stopped when reaching the suitable drilling degree of depth.Part II 510 provides alignment information for user.As an example, embodiment as shown in Figure 9 can be used to obtain the data of the drilling degree of depth.
Figure 21 shows another embodiment of marker recognition device.This marker recognition device is configured so that demonstrate position and trace information by LED thus realize suitable alignment.The size of LED can demonstrate the additional information relevant to the required amplitude of accommodation.This track lamp can demonstrate the simple toggle switch between the track and unjustified track of alignment.As another example, color coding can be carried out to track LED to provide the suggestion of the required amplitude of accommodation thus to realize suitable alignment.
Figure 22 shows the first embodiment inserting handle 700.This insertion handle 700 comprises arcuate slot 710.This arcuate slot limits the movement of marker recognition device 18,118 in working place.When identifying screw blind hole, this arcuate slot limits the movement of drill sleeve thus carries out fine adjustment to its position.In certain embodiments, insert handle 700 and comprise support 712, described support receives marker recognition device and advances in slit 710.
Figure 23 shows the 3rd embodiment of the system for identification marking.In this embodiment, rectificating surgery implant 800 is hone lamella and inserts handle 810 by the attached guiding device be affixed on this hone lamella.In the embodiment shown, inductance sensor is placed on the surface of rectificating surgery implant 800 relative to one or more labelling.Guiding device 810 makes marker recognition device 818 can carry out translation and/or rotation relative to guiding device, and to make marker recognition device suitably align with labelling 802, described labelling is such as fastener hole.In addition, for arranging the situation of multiple fixing hole over the implant, the additional bullport 812 that guiding device 810 is arranged can contribute to the position close to additional fixing hole.
Figure 24 shows the second embodiment inserting handle.This insertion handle 900 comprises by using the position of small servo motor 920,922,924 pairs of marker recognition devices 918 to carry out fine adjustment.Servo motor 920,922,924 can regulate the orientation of marker recognition device 918 and position.By automated manner or can be controlled this servo motor by surgeon.
Figure 25 shows the 3rd embodiment of bone 100 and the system 1010 for identification marking.System 1010 comprises control unit 1012, field generator 1014, marker recognition device 1016, intramedullary pin 1024 and detector 1029.Marker recognition device 1016 also can be called target locating set.Control unit 1012 can be included as a part for processor mentioned above or can be an independent unit.Intramedullary pin 1024 is inserted in bone 100, and intramedullary pin 1024 has hole or labelling 1028.In the illustrated embodiment, field generator 1014 is electrically connected to control unit 1012.In the illustrated embodiment, insert handle 1022 to be detachably attached to above intramedullary pin 1024.Insertion handle 1022 and/or intramedullary pin 1024 can with intubate.In certain embodiments, insert handle 1022 and comprise the 3rd sensor 1032.
Marker recognition device 1016 comprises the second sensor 1020.The bootable drill bit 1018 of marker recognition device 1016, and drill bit 1018 can be connected to above drilling tool (not shown).Or by wired mode or wirelessly, the second sensor 1020 can be connected to control unit 1012.In certain embodiments, field generator 1014 can be directly installed on above marker recognition device 1016.
Detector 1029 comprises tinsel 1030, band 1034 and backstop 1036.In the illustrated embodiment, 1034 are with to be can from the rustless steel winding of 300 series of wide 0.125 inch 0.060 inch of the Ideal Industries of Sycamore, Illinois, Inc. acquisition.But, it should be appreciated by those skilled in the art: also can use other material and other size.Such as, the arrowband of any polymer, composite or metal can be used as band 1034, but preferably uses nonferrous metal.Before laying and entering into intramedullary pin 1024, band 1034 can reel.Winding with 1034 may cause described band to have natural curvature.In certain embodiments, be with 1034 can have the orientation that participates in described band and be placed in rectangular geometry in the intubate of intramedullary pin 1024 to make it.Also ellipse, square or circular geometry can be adopted.In certain embodiments, tinsel 1030 can be operatively coupled on band 1034.Such as, by using binding agent or fastener to realize this process.Scale or the locking key of the degree of depth of described band is represented when can be included in be inserted in implant with 1034.
Or by wired mode or wirelessly, first sensor 1026 is connected to control unit 1012.In the illustrated embodiment, by using tinsel 1030 to be connected first sensor 1026 with adapter 1038.In certain embodiments, adapter 1038 can be saved.First sensor 1026 can be connected to the far-end of band 1034, and backstop 1036 can be connected to the near-end of band 1034.
In certain embodiments, detector 1029 can comprise the sensor outer housing (not shown) covering first sensor 1026.This sensor outer housing can be attached to above band 1034.Sensor outer housing can be made up of nonferrous material such as polymer, composite or metal.This sensor outer housing can comprise suitable strain relief thus protection tinsel 1030 is not subject to stress.This sensor outer housing can be constructed and arranged to enough large in order to keep first sensor 1026 and to be constructed and arranged to the enough little intubate in order to assemble by inserting handle or implant.In addition, this sensor outer housing can be constructed and arranged to long enough to allow by the bending section in intramedullary pin bending section, intramedullary pin arcuate section and/or pertinent instruments.The front end face of this sensor outer housing and rear end face can be designed thus this sensor outer housing can not be kept off or be stuck in above the intubate of described instrument or implant.
Backstop 1036 can be used to control laying of sensor 1026.If band 1034 length are fixed and known to inserting the end of handle to the distance in hole 1028, can repeatedly laying of first sensor 1026 so can be realized.Band 1034 can have sufficiently long length, thus sensor 1026 is alignd with hole 1028, contiguous described hole 1028, or produces skew from described hole 1028.
In certain embodiments, insertion handle 1022 can be saved.In this case, different belt length can be selected.Thus make a part or the end of backstop 1036 jointing nail 1024.
Figure 26 shows the detailed view in intramedullary pin 1024, sensor 1026 and hole 1028.Sensor 1026 aligns with hole 1028, contiguous described hole 1028, or produces skew from described hole 1028.In the illustrated embodiment, sensor 1026 contiguous described hole 1028 substantially.
In use, intramedullary pin 1024 is placed in bone 100.Insert handle 1022 can be attached to above intramedullary pin 1024.Detector 1029 is supplied to the intubate by inserting handle 1022 and enters into the intubate of intramedullary pin 1024 until backstop 1036 engages insertion handle 1022.In a particular embodiment, tinsel 1030 is connected on control unit 1012, and uses control unit 1012 pairs of sensors 1026,1020 and 1032 to calibrate.In certain embodiments, detector 1029 can be removed after calibrating.If so, the relative position of the 3rd sensor 1032 and transformation matrix identification second sensor 1020 can be used, thus marker recognition device 1016.Selectively, user can use and pierce through element, such as screw, thus the near-end of first locking of intramedullary nails.Operator's usage flag evaluator 1016 and first sensor 1026 carry out identification marking 1028.Such as, when Intramedullary nailing, surgeon's usage flag evaluator 1016 identifies blind pierced holes and drilling pierces through element through described hole in order to lay.
Figure 27 shows a packaging embodiment.Usually, intramedullary pin must sterilize before implanting.If be just installed in intramedullary pin by sensor before sterilizing, so in sterilization process, if particularly sterilization process relates to radiation, sensor may lose its calibration degree.Such as, gamma-radiation can be used for sterilizing to seal member such as sensor.Embodiment shown in Figure 27 shows the mode keeping intramedullary pin aseptic while allowing to re-start calibration to sensor.Embodiment shown in Figure 27 comprises the first packaging 1040, second and packs the 1042, first adapter 1044, second adapter 1046 and cable 1048.In the illustrated embodiment, sensor (not shown) and intramedullary pin 1024 are positioned at the first packaging 1040.Another kind of optional manner is that detector 1029 and sensor are positioned at the first packaging 1040.In another example, only sensor is positioned at the first packaging 1040.Memory (not shown) can be connected to sensor.Memory can be used to stored calibration transformation matrix (x1, y1, z1, x2, y2, z2) and other data, the length of such as intramedullary pin or detector and size.Memory can be mounted or be placed in above intramedullary pin 1024 or detector 1029.First adapter 1044 is electrically connected, but is removably attached, above the second adapter 1046.First adapter 1044 is also electrically connected to above sensor or memory.First packaging 1040 keeps the device in it aseptic.Cable 1048 is electrically connected to the second adapter 1046 and memory (not shown).Calibration for described sensor is downloaded and is transferred to sensor and memory by adapter 1044,1046 above storage device.Calibration steps can be performed in the fabrication process or just before implantation implant.
Figure 28 shows the method this system 1010 being connected to network.Figure 28 shows network 1060, accountant 1050, cable 1048, second adapter 1046, first adapter 1044 and intramedullary pin 1024.In the illustrated embodiment, sensor (not shown) is positioned at intramedullary pin 1024.Another kind of optional manner is, sensor can be attached to detector 1029 or freestanding above.In certain embodiments, intramedullary pin 1024 can be enclosed in packaging such as the first packaging 1040 and/or the second packaging 1042, but also always not like this.Memory (not shown) can be connected to sensor.Memory (not shown) can be connected to sensor.Memory can be used to stored calibration transformation matrix (x1, y1, z1, x2, y2, z2) and other data, the length of such as intramedullary pin or detector and size.Memory can be mounted or be placed in above intramedullary pin 1024 or detector 1029.Network 1060 can be LAN or wide area network.Accountant 1054 is connected in network 1060.In certain embodiments, can be encrypted network service.By using adapter 1044,1046, accountant 1054 is connected to above sensor or memory by cable 1048.In this manner, the calibration of described sensor can be downloaded above accountant 1054 and/or network 1060.Although illustrated in illustrated embodiment that sensor is positioned at intramedullary pin, also always not like this.Sensor can be attached to above detector or freestanding.In certain embodiments, memory can be positioned at control unit, and control unit is connected to network so that download calibration data.
Figure 29 shows the 4th embodiment of the system 1110 for identification marking.System 1110 comprises control unit 1112, field generator 1114, marker recognition device 1116, intramedullary pin 1124, lower falling bodies 1136 and detector 1129.Control unit 1112 can be included as a part for processor mentioned above or can be an independent unit.Intramedullary pin 1124 is inserted in bone 100, and intramedullary pin 1124 has hole or labelling 1128.In the illustrated embodiment, or by wired mode or wirelessly, field generator 1114 is electrically connected to control unit 1112.In the illustrated embodiment, insert handle 1122 to be detachably attached to above intramedullary pin 1124.Insertion handle 1122 and/or intramedullary pin 1124 can with intubate.In certain embodiments, insert handle 1122 and comprise the 3rd sensor 1132.Lower falling bodies 1136 can comprise four-sensor 1139.
Marker recognition device 1116 comprises the second sensor 1120.The bootable drill bit 1018 of marker recognition device 1116, and drill bit 1018 can be connected to above drilling tool (not shown).Or by wired mode or wirelessly, the second sensor 1120 can be connected to control unit 1112.In certain embodiments, field generator 1114 can be directly installed on above marker recognition device 1116.
Detector 1129 comprises tinsel 1130, band 1134 and backstop 1136.In certain embodiments, be with 1134 can have the orientation that participates in described band and be placed in rectangular geometry in the intubate of intramedullary pin 1124 to make it.In certain embodiments, tinsel 1130 can be operatively coupled on band 1134.Such as, by using binding agent or fastener to realize this process.Or by wired mode or wirelessly, first sensor 1126 is connected to control unit 1112.In the illustrated embodiment, by using tinsel 1130 to connect first sensor 1126.In certain embodiments, detachable connector can be used.First sensor 1126 can be connected to the far-end of band 1134, and backstop 1136 can be connected to the near-end of band 1134.Backstop 1136 can be used to control laying of sensor 1126.If band 1134 length are fixed and known to inserting the end of handle to the distance of labelling 1128, can repeatedly laying of first sensor 1126 so can be realized.Band 1134 can have sufficiently long length, thus sensor 1126 is alignd with labelling 1128, contiguous described labelling 1128, or produces skew from described labelling 1128.
In use, intramedullary pin 1124 is placed in bone 100.Insert handle 1122 can be attached to above intramedullary pin 1124.Detector 1129 is supplied to by inserting handle 1122 and entering into intramedullary pin 1124 until backstop 1136 engages insert handle 1122.In a particular embodiment, tinsel 1130 is connected on control unit 1112, and uses control unit 1112 pairs of sensors 1126,1120 and 1132 to calibrate.In certain embodiments, detector 1129 can be removed after calibrating.If so, the relative position of the 3rd sensor 1132 and/or four-sensor 1139 and transformation matrix identification second sensor 1120 can be used, thus target locating set 1116.Selectively, user can use and pierce through element, such as screw, thus the near-end of first locking of intramedullary nails.Operator's usage flag evaluator 1116 and first sensor 1126 carry out identification marking 1128.Such as, when Intramedullary nailing, surgeon's usage flag evaluator 1116 identifies blind pierced holes and drilling pierces through element through described hole in order to lay.
Figure 30 shows the first method for using this system identification labelling.The method is from step 1210.In step 1212, sensor is placed in nail.In step 1214, insertion handle is connected to and nails on, and lower falling bodies are attached on insertion handle.In step 1216, control unit is connected to sensor.In step 1218, sensor is calibrated.In step 1220, sensor aligns with hole.In step 1222, by using control unit, sensing station goes on record.In step 1224, from nailing on face removal sensor.In step 1226, nail is implanted in bone.In step 1228, use target locating set boring.The method ends at step 1230.
Figure 31 shows the second method for using this system identification labelling.In step 1310, tracing system is switched on.In step 1312, intramedullary pin is inserted in bone.In step 1314, detector is inserted in intramedullary pin pipeline with precalculated position and orientation.In step 1316, need to judge that intramedullary pin is that needs carried out near-end locking before far-end.If so in step 1326, lower falling bodies are attached to and nail on.In step 1328, the side-play amount between calculating detector and lower falling bodies.In other words, transformation matrix is produced.Another kind of optional manner is that lower falling bodies are not connected with intramedullary pin, but uses to be installed in and insert sensor in handle to calculate side-play amount.In step 1330, remove detector from nailing on face.In step 1334, described nail is locked by near-end.This process is by usage flag evaluator, mechanical clamp or manually operate and be achieved.In step 1336, marker recognition device is used to carry out target localization to drilling tool.In step 1338, get out the hole for distal screw.In step 1340, intramedullary pin is by far-end locking.On the other hand, if judge first to carry out far-end locking, so in step 1318, marker recognition device and detector are used to carry out target localization to drill bit.In step 1320, the hole for distal screw is got out.In step 1322, intramedullary pin is by far-end locking.In step 1324, above intramedullary pin, remove detector.In step 1324, intramedullary pin is locked by near-end.This process is by usage flag evaluator, mechanical clamp or manually operate and be achieved.
Figure 32 shows a kind of system of laying the degree of depth for measuring drill bit.System 1400 comprises stator 1410 and sliding part 1412.Stator 1410 and sliding part 1412 define the capacitive character array that can sense relative motion.The voltage pulsation making stator 1410 and sliding part 1412 relative to each other carry out Linear-moving to cause can being interpreted as and being used to the distance determining to have advanced.In certain embodiments, electronic measurement circuit (not shown) and sliding part 1412 can be housed in marker recognition device, and drill bit can be specially constructed into the stator 1410 had along outer surface, thus make stator 1410 and sliding part 1412 very linearly close to each other.The Linear-moving of drill bit stator 1410 is receiving the voltage responded in sliding part 1412 and produce and can be interpreted as the range measurements of electronic measurement circuit.This range measurements can be sent to control unit and/or be shown on a monitor.Capacitance sensor is very responsive for dampness, and therefore some embodiments can be used for preventing liquid such as body fluid from flowing between stator 1410 and sliding part 1412.Can in conjunction with O shape circle or the wiper of some other similar type in marker recognition device, to keep drill bit to be dry substantially.
Figure 33 A and 33B shows another kind of system of laying the degree of depth for measuring drill bit.System 1500 comprises reflection code-disc or bar 1510, lens 1512 and encoder 1514.Lens 1512 by light focusing on code-bar 1510.Along with code-bar 1510 rotates, the alternating pattern of the light projected by window and code-bar respectively drops on above the photodiode of encoder 1514.This pattern transformation is become to represent that the numeral of code-bar linear movement exports by encoder 1514.In the illustrated embodiment, the encoder used is can from 350 W Trimble Road, the AEDR-8300 type reflective optical encoder of the Avago Technologies acquisition of San Jose, California.Another kind of optional manner also to use the LED-based navigation system of Avago Technologies ADNS-5000 One Chip USB.It is inner that encoder and support electronic installation thereof can be installed in marker recognition device, thus make its input area orientation towards " window " in marker recognition device intubate.Mark, such as dark concentric ring or light tone tore of reflection can be added to above drill bit, to strengthen the visibility of drill bit relative to encoder.These marks also can in order to indicate the beginning zero point for measuring.Along with drill bit carries out Linear-moving in marker recognition device, encoder measures the movement of described drill bit.This range measurements can be sent to control unit and/or be shown on a monitor.
Figure 34 shows another system for measuring the drilling degree of depth.System 1600 employs linear variable difference transformer (LVDT) 1612.Linear variable difference transformer is a kind of transformator for measure linear displacement.Linear variable difference transformer 1612 comprises multiple end-to-end magnetic plug 1618 carrying out laying around pipeline 1610, and it is marker recognition device in the illustrated embodiment.In the embodiment shown in Figure 34, centering coil is primary coil, and two coils of outside are secondary coils.Columniform ferromagnetic core 1610 such as drill bit slides along the axis of pipeline.Alternating current 1614 is driven through primary coil, causes responding to generation voltage pro rata with its mutual inductance with primary coil in each secondary coil.Pickoff sensor 1616 measures the size of output voltage, and described output voltage is directly proportional to the distance (being up to its extreme limit of travel) of fuse movement.The phase place of voltage represents the direction of this displacement.Because sliding core does not contact the inside of pipeline, therefore it can move under friction free condition, thus makes linear variable difference transformer become one device highly reliably.Without any slip or rotating contact, linear variable difference transformer is completely sealed relative to environment.This range measurements can be sent to control unit and/or be shown on a monitor.
Figure 35-37 shows and inserts handle 1700 and scalable backstop 1800.Insert handle 1700 and there is the drill steel 1710 be connected with implant such as intramedullary pin (not shown) in end portion office 1712.Insertion handle 1700 can comprise the quick connector 1716 for being attached to above lower falling bodies, near-end target locating set or some Other Instruments or equipment.Insert handle and comprise top section 1714, described top section can comprise hole and/or alignment feature.Scalable backstop 1800 can comprise slit 1810, alignment member 1812 and fastener hole 1814.
In the embodiment shown in Figure 35-37, scalable backstop 1800 can be detachably attached to above top section 1714.In certain embodiments, scalable backstop can be integrally formed with insertion handle 1700.In other embodiments, scalable backstop for good and all can be attached to and be inserted above handle 1700.In the illustrated embodiment, alignment member 1812 be assemblied in described top section alignment feature in thus prevent scalable backstop from rotating.Fastener (not shown) can be placed through fastener hole 1814 thus scalable backstop is attached to and insert above handle 1700.Band 1034,1134 can be placed through slit 1810, enters into intramedullary pin intubate through drill steel 1710.Slit 1810 can have the shape matched with the geometry of band, thus contributes to its insertion or prevent described band from rotating.Band 1034,1134 can comprise for representing for the mark of given nail long speech expression appropriate depth, scale or locking key.In certain embodiments, scalable backstop 1800 can comprise the locking mechanism (not shown) for locking strip 1034,1134 temporary transient at certain depth place.The most simply, this locking mechanism can be the fastener of frictional engagement band 1034,1134.
Figure 38 shows the method for calibration for this system of identification marking.For accuracy, calibration is necessary.The method is from step 1900, and this step can comprise for this system energization.In step 1910, if wrapped words, remove detector and marker recognition device from packaging, and detector and marker recognition device are scanned.In certain embodiments, equally lower falling bodies are scanned.This scanning can comprise use bar code reader and read bar code.This scanning causes this system in step 1912 to fetch the offset sensor data corresponding with the bar code in question blank.This question blank can be local or with network as the Internet is connected.Another kind of optional manner is that detector and marker recognition device can comprise serial number or other unique evaluator, and this unique evaluator is combined with question blank thus fetches offset sensor data.In step 1914, these offset sensor data are stored in the local memory of system.In step 1916, user lays detector relative to implant and attempts usage flag evaluator and follows the trail of labelling.In step 1918, judge whether that it is correct for calibrating.If the method ends at step 1920.Otherwise, in step 1912, fetch new shift value.
In a particular embodiment, the feedback information provided is selected from auditory information, visual information and tactile data.Auditory feedback is output by speaker, headphone, ear bud or earphone.Radio frequency or ground data transmission can be utilized and transmit auditory feedback signal by wired or wireless mode.Visual feedback is output by cathode ray tube, liquid crystal display or plasma scope.As an example, visual feedback means can comprise TV monitor, personal digital assistant or personal multimedia player.Radio frequency or ground data transmission can be utilized and transmit visual feedback signal by wired or wireless mode.Tactile feedback is output by glove, utensil or carpet.Radio frequency or ground data transmission can be utilized and transmit tactile feedback signal by wired or wireless mode.
The present invention comprises a kind of method for identification marking further.Said method comprising the steps of: rectificating surgery implant assembly is provided, described rectangle implant assembly has rectificating surgery implant and dismountable lead-in wire, described rectangle implant has longitudinal groove, described dismountable lead-in wire is attached with magnetic transducing and is positioned at described longitudinal groove, described rectificating surgery implant has proximal part, distal portions and is positioned at least one labelling on described distal portions; By in described rectificating surgery implant assembly implantation; First will pierce through element is arranged in described proximal part; Usage flag evaluator identifies at least one labelling described; After first piercing through element and being arranged in described proximal part, be arranged on be arranged at least one labelling described in described distal portions by piercing through element; And remove described dismountable lead-in wire.The method makes to make before carrying out far-end locking, to carry out near-end locking to this implant.This is the obvious advantage being better than prior art, this is because existing device needs to carry out far-end locking before carrying out near-end locking.
In the fabrication process, after the distribution or just feasible system calibration before the implantation of implant.Registration in calibration steps and computer-assisted surgery is similar.May need because of different reasons to calibrate.Such as, may need carry out pick up calibration thus revise manufacturing tolerance.Described system designs based on Computer Aided Design Model, and calibration is used to lay sensor exactly relative to each other.Described processor or control unit can comprise for generating X, Y, Z, pitching (pitch), side-sway (yaw) and rolling (roll) shift value thus relative to each other being laid in global coordinate system or simply by described sensor localization.In one embodiment, described system is produced in the fabrication process and is calibrated, and has been assigned with unique identifier, such as serial number, colour coding, bar code or RF identification (RFID) label.If described system needs to recalibrate, so or in local or unique identifier can be used on network to fetch shift value.Further, unique identifier can be used to fetch other data, the length of the size of such as intramedullary pin or intramedullary pin and/or detector.
Can be seen by description above: realized by the present invention and obtain multiple advantage.
To select above and the embodiment described is intended to set forth best principle of the present invention and practical application thereof, make one of ordinary skill in the art can use multiple embodiment of the present invention in the best way thus, and envision the various modification being suitable for special-purpose.
Due to can when not departing from scope of the present invention to describe at this and illustrated structure and method make multiple modification, to comprise in the description therefore or all the elements illustrated in the accompanying drawings should be interpreted as exemplary and nonrestrictive.Such as, although Fig. 1 shows for by attached for the first sensor recess be affixed in implant, other structure and/or method also can be used to consolidate attached for these objects together.Therefore, range of the present invention and scope should not be limited to any embodiment in any above-mentioned exemplary embodiments, but should only according to appended following claims and this range of equivalents thereof and scope.

Claims (11)

1., for a system for identification marking, described system comprises:
A. for generation of the field generator in magnetic field;
B. be positioned at the rectificating surgery implant in described magnetic field, described rectificating surgery implant has at least one labelling;
C. there is dismountable detector of the first magnetic sensor separated with at least one labelling described;
D. there is the marker recognition device of the second magnetic sensor; With
E. processor, described processor is for the sensing data that contrasts from described first sensor and described second sensor and use described setpoint distance to calculate the position of described marker recognition device relative at least one labelling described.
2. system according to claim 1, wherein said labelling is selected from the cohort comprising structure, space, projection, passage, brake, flange, groove, component, separator, step, hole, hole, cavity, recess, conduit, gap, recess, aperture, path, otch, eyelet or slit.
3. system according to claim 1 and 2, wherein said rectificating surgery implant is intramedullary pin.
4. the system according to any one of claim 1-3, wherein said rectificating surgery implant has outer surface, forms the inner surface of intubate and the wall portion between described outer surface and described inner surface.
5. the system according to any one of claim 1-4, comprises the insertion handle that is detachably attached on described rectificating surgery implant further and described insertion handle has the 3rd sensor.
6. the system according to any one of claim 1-5, comprises the watch-dog being electrically connected to described processor further.
7. the system according to any one of claim 1-6, comprises the lower falling bodies with four-sensor further.
8. the system according to any one of claim 1-7, wherein said dismountable detector comprises band further.
9. the system according to any one of claim 1-8, wherein said marker recognition device comprises drill sleeve.
10. the system according to any one of claim 1-8, wherein said marker recognition device comprises serrated tip further.
11. systems according to any one of claim 1-10, wherein said processor provides feedback information for user.
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