CN104799904B

CN104799904B - System and method for recognizing mark

Info

Publication number: CN104799904B
Application number: CN201510252975.8A
Authority: CN
Inventors: 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
Original assignee: Smith and Nephew Richards Inc
Current assignee: Smith and Nephew Inc
Priority date: 2008-02-28
Filing date: 2008-08-27
Publication date: 2017-10-27
Anticipated expiration: 2028-08-27
Also published as: CA3043572A1; CA3043572C; JP2015061666A; CN104799904A; WO2009108214A1

Abstract

The present invention discloses a kind of system for being used to recognize mark（1010、1110）.The system includes the field generator for being used to produce magnetic field（1016、1116）, rectificating surgery implant in the magnetic field（1030、1130）, the implant is with least one mark（1028,1128）, with the first magnetic sensor（1026,1126）Dismountable detector（1029,1129）, with the second magnetic sensor（1020、1120）Marker recognition device（1016、1116）And processor（1012、1112）, the processor is for contrasting the sensing data from the first sensor and the second sensor and position of the marker recognition device relative at least one mark being calculated using setpoint distance.The invention enables can carry out blind target positioning to one or more marks.

Description

System and method for recognizing mark

The application is divisional application, and the Application No. 200880128908.3 of original application, the applying date is October 28 in 2010 Day, entitled " being used for the system and method for recognizing mark ".

Cross reference to related applications

This application claims the Application No. PCT/US2008/55300 submitted for 29 days 2 months in 2008 pct international patent The rights and interests of application.The overall disclosure content of this application, which is described herein by reference, to be cited.

It is related to the statement of the research or development of federal patronage

It is inapplicable.

Annex

It is inapplicable.

Technical field

Embodiments of the invention relate generally to rectificating surgery implant, and more particularly, embodiments of the invention are related to knowledge Blind mark on other rectificating surgery implant（blind landmark）.

Background technology

The use of interlocking femur pin has been widened in the marrow of long bone fracture significantly（IM）Fixed range.The locking of intramedullary nail causes Above-mentioned construction is more stable and stopped and follow closely rotation in bone along longitudinal direction.Typical Intramedullary nailing surgical operation is related to and will pressed from both sides Tool, x-ray imaging device and artificial visual inspection apparatus are combined for positioning and getting out distal screw holes.

In the surgical procedures, intramedullary nail is hammered in the conduit of fractured long bones so that the end of fracture is fixed on Together.Under normal circumstances, that implements first is near-end locking and implements the near-end locking usually using fixture.However, nail exists During in insertion marrow the deformation that produces can cause to occur for distal screw fixture it is inaccurate in the case of.Main is tired Difficulty be to far-end locking screw carry out positioning and make drilling tool align to get out distal screw holes the step of because This be in whole implantation process most it is time-consuming also most challenge the step of.Therefore, it is impossible to which implement far-end locking two are main former Because being that inlet point on bone is inaccurate and misorentation of drilling tool.If there is mistake in any factor in the two factors, Then drilling tool will not pass through nail.

The problem of inaccurate rounded ends for also making drill bit of inlet point generally occur within skidding is more complicated, and so that It is difficult to set another drilling adjacent with the relatively early drilling formed.Inaccurate far-end locking can cause prematurely to ruin Damage, and the nail through nail fracture is occurred, is made screw occur being broken or be broken the drill bit in bone.

Manual technique is the most universal also most received technology for being used to observe distal screw holes and produced in orthopaedic srugery Superiority is occupied in industry.Most remote target location technology can all use bushing（Cylindrical sleeve）To guide drilling tool. Make the guide bushing align and hold it in appropriate position mechanism it is different.In some cases, surgeon makes Use half sleeve（Along the bushing for being slit longitudinally into two halves）Or complete sleeve helps the steady drill bit in drilling process.In any feelings Under condition, surgeon will implement to cut to patient and drilling tool is inserted through into the otch.Manual technique is based primarily upon surgery doctor Raw manual technique and the x-ray imaging device and mechanical clamp for having used radiography.

Realize that another method of the purpose is that so-called " standard round is used with the help of C-arm portion in long nail on （perfect circle）" technology.In this case, technical staff is oriented to patient and C-arm portion, so that working as During using the fluoroscopic observation implant, the hole that screw will be passed through shows round shape.If C-arm portion is not Perpendicular to the hole, then it will be presented ellipse or not exist even.

In the art, it is still necessary to provide it is a kind of be used for medical implant mark carry out target positioning system and Method.Further, in the art, it is still necessary to far-end locking screw is accurately positioned and need to make drilling tool alignment with Just distal screw holes are got out.

The content of the invention

The invention provides a kind of system for being used to recognize mark, the system includes：Field for producing magnetic field occurs Device；Rectificating surgery implant in the magnetic field, the rectificating surgery implant is marked with least one；With with institute State the dismountable detector for the first magnetic sensor that at least one mark is separated；Mark with the second magnetic sensor is known Other device；And processor, the processor is for contrasting the sensor number from the first sensor and the second sensor According to and using the setpoint distance come calculate the marker recognition device relative to it is described at least one mark position.

Present invention also offers a kind of system for being used to recognize mark, the system includes：Send out field for producing magnetic field Raw device；Rectificating surgery implant in the magnetic field, the rectificating surgery implant has at least one mark and longitudinal direction Groove, the longitudinal groove has proximal part and distal portions；First magnetic sensor, first magnetic sensor is in institute State longitudinal groove the distal portion office be installed on the rectificating surgery implant and with it is described at least one mark every Open up set a distance；Marker recognition device with the second magnetic sensor；And processor, the processor is for contrasting from described First sensor and the sensing data of the second sensor and the marker recognition is calculated using the setpoint distance Position of the device relative at least one mark.

According to some embodiments, the mark be selected from include structure, space, projection, passage, brake, flange, groove, Component, separator, step, hole, hole, cavity, recess, conduit, gap, recess, aperture, path, otch, eyelet or slit Group.

According to some embodiments, the rectificating surgery implant is intramedullary nail.

According to some embodiments, the rectificating surgery implant has outer surface, the inner surface for forming intubation and positioned at it Between wall portion, and first magnetic sensor is installed in the wall portion.

According to some embodiments, the rectificating surgery implant further comprises recess and the first sensor is set In the recess.

According to some embodiments, the rectificating surgery implant further comprises lid.

According to some embodiments, the rectificating surgery implant further comprises being suitable to the second opening for receiving lid.

According to some embodiments, the rectificating surgery implant further comprises circumferential recess.

According to some embodiments, the system includes being connected to the lead of the first magnetic sensor.

According to some embodiments, the system includes the insertion being detachably attached on the rectificating surgery implant Handle.

According to some embodiments, the system includes being electrically connected to the monitor of the processor.

According to some embodiments, the system includes being connected to dismountable lead of the first sensor.

According to some embodiments, the longitudinal groove is set along the outer surface of the implant.

According to some embodiments, the rectificating surgery implant further comprise intubation, and the longitudinal groove generally with The intubation is adjacent.

According to some embodiments, the marker recognition device includes drill sleeve.

According to some embodiments, the marker recognition device further comprises serrated tip.

According to some embodiments, the marker recognition device further comprises pipeline.

According to some embodiments, the marker recognition device further comprises identifying sensor（marking sensor）.

According to some embodiments, the marker recognition device further comprises handle.

According to some embodiments, the processor has provided the user feedback information.

The invention provides a kind of system for being used to recognize mark, the system includes：Field for producing magnetic field occurs Device；Rectificating surgery implant in the magnetic field, the rectificating surgery implant is marked with least one；Magnet, institute Magnet is stated to be installed on the rectificating surgery implant and separate setpoint distance with least one described mark；Passed with magnetic The marker recognition device of sensor；And processor, the processor is for contrasting the sensing data from the magnetic sensor simultaneously And position of the marker recognition device relative at least one mark is calculated using the setpoint distance.

The invention provides a kind of method for being used to recognize mark, methods described includes：Rectificating surgery implant group is provided Part, the rectangle implant component has rectificating surgery implant and dismountable lead, and the rectangle implant has longitudinal direction Magnetic transducing is attached with groove, dismountable lead and in the longitudinal groove, the rectificating surgery implant At least one mark with proximal part, distal portions and on the distal portions；By the rectificating surgery implant In component implantation；Element is will puncture through first in the proximal part；Using marker recognition device to it is described at least One mark is identified；After it will puncture through element first in the proximal part, it will puncture through element and install in place In at least one mark described in the distal portions；And remove dismountable lead.

The invention provides a kind of patterned user interface, the patterned user interface includes：Represent relative to The Part I of the drilling depth of implant；And Part II, the Part II represents the marker recognition device relative to mark Position, the mark is located on the implant.

The present invention has multiple advantages better than existing apparatus and technology.First, the present invention can be independently of fluoroscopy And run and cause X-ray apparatus need not be set to carry out piercing element target positioning, which reduce user and patient's exposure In the degree of radiation.Secondly, drive end can be locked before locking anti-drive end the invention enables user.In other words, one In a little embodiments, the present invention need not use implant to be intubated and make it that near-end locking can be carried out before far-end locking is carried out.

Below in conjunction with accompanying drawing to further aspect of the present invention, aspect and advantage and the multiple embodiments of the present invention Structure and operation are described in detail.

Brief description of the drawings

Accompanying drawing is included in this manual and constitutes the part of this specification.The implementation of the present invention is shown in figure Example, and accompanying drawing together with following specification be used for explain the present invention principle.In the accompanying drawings：

Fig. 1 shows the first embodiment of the system for recognizing mark；

Fig. 2 is the sectional view of the first embodiment of rectificating surgery implant component；

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 component；

Fig. 7 is the front view of dismountable lead；

Fig. 8 is the top view of rectificating surgery implant component shown in Fig. 6；

Fig. 9 shows marker recognition device；

Figure 10 is the sectional view for showing the point contact in first embodiment；

Figure 11 is the sectional view for showing the point contact in second embodiment；

Figure 12 A are the sectional views for the arrangements of electric connection for showing cockle；

Figure 12 B are the schematic diagrames for showing the arrangements of electric connection in the first optional implementation profit;

Figure 12 C are the schematic side views for showing arrangements of electric connection shown in Figure 12 B;

Figure 12 D are the schematic diagrames for showing the arrangements of electric connection in the second optional implementation profit;

Figure 13 A be show first implement profit in be used for make rectificating surgery implant with insert handle align it is other optional The fragmentary perspective view of mechanism；

Figure 13 B are shown to be used to make rectificating surgery implant align with arrangements of electric connection in the second optional implementation profit The fragmentary perspective view of other optional mechanisms;

Figure 14 shows the connection of insertion handle and rectificating surgery implant；

Figure 15 shows the second embodiment of the system for recognizing mark；

Figure 16 is the schematic diagram for showing visual field selection standard；

Figure 17 is to show that the visual field selects the flow chart of step；

Figure 18 is the schematic diagram for showing the first alternative for making marker recognition device align；

Figure 19 is the schematic diagram for showing second of alternative for making marker recognition device align；

Figure 20 shows the exemplary view of monitor；

Figure 21 shows another alternative embodiment of marker recognition device；

Figure 22 shows the first alternative embodiment of insertion handle；

Figure 23 shows the 3rd embodiment of the system for recognizing mark；

Figure 24 shows the second alternative embodiment of insertion handle；

Figure 25 shows the 3rd embodiment of the system for recognizing mark；

Figure 26 shows the detailed viewgraph of cross-section of intramedullary nail；

Figure 27 shows a packaging embodiment；

Figure 28 shows the method that the system is connected to network；

Figure 29 shows the fourth embodiment of the system for recognizing mark；

Figure 30 is shown for the first pass figure using the system；

Figure 31 is shown for the second flow chart using the system；

Figure 32 shows the second embodiment for following the trail of drilling depth；

Figure 33 A and 33B show the 3rd embodiment for following the trail of drilling depth；

Figure 34 shows the fourth embodiment for following the trail of drilling depth；

Figure 35 shows insertion handle；

Figure 36 shows the top perspective of adjustable backstop；

Figure 37 shows the bottom perspective view that backstop is can adjust shown in Figure 36；With

Figure 38 shows the 3rd flow chart for system calibration.

Embodiment

Referring to accompanying drawing, similar reference represents similar element in figure, and Fig. 1 shows the system for recognizing mark 10 first embodiment.System 10 includes processor 12, magnetic field generator 16, marker recognition device 18 and rectificating surgery implant group Part 28.In certain embodiments, system 10 further comprises the monitor 14 for being electrically connected to processor 12 and by removably It is attached to the insertion handle 40 on rectificating surgery implant component 28.Processor 12 is illustrated as desktop computer in Fig. 1, but equally Other types of computing device can also be used.As example, processor 12 can be desktop PC, laptop computer, Personal digital assistant（PDA）, mobile handsets or special purpose device.In the embodiment shown in the drawings, magnetic field generator be can The device provided by following supplier：107 Catamount Drive, Milton Vermont, U.S.A.'s Ascension Technology Corporation； 103 Randall Drive, Waterloo, Ontario, Canada Northern Digital Inc.；Or 40 Hercules Drive, Colchester Vermont, U.S.A. Polhemus.Certainly, it is possible to use other generators.As example, field generator 16 can provide pulse direct current electromagnetic field or Ac magnetic field.In certain embodiments, system 10 further comprises the control unit for being connected to magnetic field generator 16（Do not show Go out）.Control unit controls field generator, receives the signal from small-sized movable inductance sensor and carried out with processor 12 Communication, this is realized by wired or wireless way.In certain embodiments, control unit can be received by hardware or software Enter in processor 12.

System 10 is magnetic position tracing system.For exemplifying purpose, system 10 includes magnetic field generator 16, described Magnetic field generator includes the electromagnetic inductance coil being implemented in any suitably arranged, and the coil is used as space magnetic infrastructural frame（That is X, Y, Z）.System 10 further comprise small-sized movable inductance sensor, and the sensor is attached on the object being tracked.It should be appreciated that：It is other Modification is also to be easy to received.The position of small-sized movable inductance sensor and angular orientation depend on the sensor and by magnetic field The magnetic coupling that the source place that generator 16 is produced is carried out.

It should be noted that：Magnetic field generator 16 generate it is a series of, or one group, different space magnetic field shapes or distribution, It is six herein, each space magnetic field shape or distribution are sensed by small-sized movable inductance sensor.Each series causes small Type movement inductance sensor can produce a series of signal.Processing to this series of signal permits a determination that small-sized movable electricity The position of propagated sensation sensor and/or orientation, and therefore, it is possible to determine to be provided with the object phase of the small-sized movable inductance sensor thereon For the position of magnetic coordinate infrastructural frame, the relation of the magnetic coordinate infrastructural frame and magnetic field generator 16 is fixed.Processor 12 or control unit transformation matrix is formed using Basic Reference Coordinate System and the data that sense, the transformation matrix includes position And orientation information.

Marker recognition device 18 is used for marking, such as the mark on rectificating surgery implant component 28 carries out target positioning. Marker recognition device 18 includes one or more small-sized movable inductance sensors.In the embodiment shown in the drawings, marker recognition device 18 have second sensor 20.Marker recognition device 18 can be any amount of device.As example, marker recognition device 18 can be with It is drilling tool guide 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, The marker recognition device may include one or more of serrated tip 22, pipeline 24 and handle 26.Pipeline 24 is also known as lining Set, cylinder, guide device or drilling tool/screw lay guide device.In the embodiment shown, second sensor 20 is relative to pipe The axis in road 24 is arranged under certain orientation, and the pipeline can receive drilling tool.Sensor 20 formed relative to pipeline 24 this Plant skew and make it that the position of the pipeline and orientation can be relative to another sensors in magnetic field generator 16 or system at six Size（Three translation sizes and three Angular Dimensions）On be located in space.In some embodiments, it may be desired to place Reason device 12 is calibrated to adjust the offset distance of second sensor 20.In certain embodiments, marker recognition device 18 and field Generator 16 can be combined into single part.For example, field generator 16 can be included into handle 26.

Rectificating surgery implant component 28 includes implant 30 and one or more small-sized movable inductance sensors.Shown In embodiment, rectificating surgery implant component 28 has first sensor 32.In the embodiment shown in fig. 1, implant 30 Exist in the form of intramedullary nail, but other types of implant can also be used.As example, implant can be intramedullary nail, bone Plate, hip prosthesis or knee-joint prosthesis.First sensor 32 is set relative to one or more marks on implant 30 It is orientated into certain and is arranged on pre-position.As example, the mark can be structure, space, projection, passage, system Dynamic device, 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, mark is pierced holes 31.First sensor 32 is relative to mark shape Into this skew make it that the position of the mark can be relative to another sensor in magnetic field generator 16 or system at six Size（Three translation sizes and three Angular Dimensions）On be located in space, another sensor is, for example, the second sensing Device.In some embodiments, it may be desired to be calibrated to adjust the offset distance of first sensor 32 to processor 12.

First sensor 32 and second sensor 20 are connected to processor 12.This can be real by wired or wireless way It is existing.First sensor 32 and second sensor 20 can be the sensors with six-freedom degree, and the sensor is configured to Just along commonly referred to as X, Y and Z three translation shafts and commonly referred to as pitching（pitch）, side-sway（yaw）And rolling（roll）（That is posture, that is, around X, Y and the Z axis anglec of rotation）Three angular orientations the position of each sensor is described.By inciting somebody to action Sensor is positioned in these infrastructural frames, and knows position and the orientation of each sensor, and marker recognition device 18 can be relative to Mark on implant 30 is positioned.In a particular embodiment, the information from sensor cause surgeon can to Planned in the surgical approach being fixed and drilling tool is suitably alignd with fixed blind hole.In illustrated embodiment In, sensor 32,20 is the sensor with six-freedom degree provided by following supplier：107 Catamount Drive, Milton Vermont, U.S.A. Ascension Technology Corporation； 103 Randall Drive, Waterloo, Ontario, Canada Northern Digital Inc.；Or 40 Hercules Drive, Colchester Vermont, U.S.A. Polhemus.Certainly, it is possible to use other sensors.

First sensor 32 can be attached on implant 30.For example, first sensor 32 can be attached to outer surface 37 On.In the embodiment shown in fig. 1, implant 30 further comprises groove 34 and recess 36（It is optimal as shown in Figure 2）.Groove 34 and recess 36 be located at implant 30 wall portion in.In the embodiment shown, first sensor 32 is intended to be attached to implant All it is installed in patient body on 30 and during the service life of implant 30.Further, in certain embodiments, it is orthopedic Surgical implant component 28 includes lid 38 to cover recess 36 and/or groove 34.Lid 38 can be with implant 30 outer surface 37 Generally flush.Therefore, in certain embodiments, implant 30 includes the second opening 39（It is optimal as shown in Figure 2）To receive Lid 38.

First sensor 32 can be tied onto lead to realize communication and power.Lead and sensor can be fixed to On implant 30.Lead 50 is used to first sensor 32 being connected to processor 12 or control unit.Lead 50 can be by biology Compatible metal wire is made.As an example, lead 50 can be by Fort Wayne Metals Research Products Corp., the DFT metal wires that 9609 Indianapolis Road, Fort Wayne, Indiana 46809 are obtained are made.DFT It is Fort Wayne Metals Research Products Corp. registration mark.First connector 52 can be used for relative Lead 50 is laid in implant 30.Second connector 54 can be used for lead 50 being connected to another device, such as processor 12 or slotting Enter handle 40.

It can be used a variety of high rigidity binding agents or polymer that first sensor 32 is fixed in recess 36, it is described a variety of high Rigid binder include epoxy resin, polyurethane, polymethyl methacrylate, polyether-ether-ketone, the binding agent that can be solidified by UV, Silicone and the other cyanoacrylate of medical grade.As example, it can be used by Epoxy Technology, 14 Fortune The EPO-TEK 301 that Drive, Billerica, Massachusetts 01821 is provided.Lead 50 can be consolidated in a similar manner Determine in the trench.The fixing means of these types will not have a negative impact to the performance of electric component.Lid 38 can then be put In on implant 30 and the lid welding is in place.For example, the lid can be soldered on implant by laser welding mode.

Monitor 14 may be constructed such that position and the orientation for showing first sensor 32 and second sensor 20, so that So that can be shown as surgeon by this and provide two sensors position relative to each other and orientation.Processor 12 can lead to Cross wired mode or wireless mode to send position data to user interface, the user interface can show mark to graphically Remember the relative position between the implant on identifier and monitor.The image shown on the monitor 14 can be known relative to mark Other device is configured to certain orientation, so that surgeon can display user interface and prolonging as marker recognition device Stretch.The user interface is also configured to certain orientation, so that surgeon can be while surgical operation visual field be observed Observe the monitor.

Insertion handle 40 can be used for installing rectificating surgery implant component 28 and can be additionally used in and guiding be routed from the The lead of one sensor 32.For example, guiding leading between implant 30 and processor 12 can be routed in insertion handle 40 Believe lead and power supply lead wire.

In the embodiment shown in fig. 1, marker recognition device 18 and insertion handle 40 include being used to wirelessly to respectively Data are sent to the communication module 21,25 of processor 12 from sensor 20,32, but one of ordinary skill in the art should be appreciated that：Can Using other methods, such as by wired mode, transmission is realized.In the embodiment shown, the second connector 54 insertion communication module In 25.Another optional mode is, and just as described in greater detail below such, and implant 30 and insertion handle 40 can have phase The Electical connector of cooperation, when being assembled to part, the Electical connector being engaged forms connection, so that First sensor 32 is connected to communication module 25.

In certain embodiments, implant 30 may include telecommunication circuit and the antenna for realizing radio communication.For One sensor 32 and/or the power supply of telecommunication circuit can be positioned in insertion handle 40.For example, battery can be placed in insertion handle In 40, so as to which electrical power is sent into first sensor 32 and/or other electronic devices.Another optional mode is that communication is electric Road, antenna and battery can be located in insertion handle 40, and each part in these parts can be tied to first sensor 32 On.In another embodiment, implant 30 may include coil so as to inductively to provide electrical power and real for telecommunication circuit The data communication now carried out from first sensor 32.Power supply can be simplex power mode or can be bimodulus AC/DC.

In use, rectificating surgery implant component 28 is installed in patient body.For example, fixed inside progress In the case of, intramedullary nail is placed in marrow inner catheter.Optional mode is that piercing element, such as screw, so as to first can be used in user The near-end of intramedullary nail is locked.Operator is using target locating set 18 and first sensor 32 to recognize mark 31. For example, in the case where carrying out Intramedullary nailing, surgeon is identified simultaneously using 18 pairs of puncture blind holes of target locating set The hole is drilled through to lay piercing element.

Fig. 2 further illustrates the implant 30 shown in Fig. 1.Implant 30 include first sensor 32, longitudinal groove 34, Recess 36, the opening of lid 38 and second 39.As example, lid 38 may include gold or titanium foil sheet.In certain embodiments, implant 30 Including inner surface 35, the inner surface forms intubation 33.Implant 30 includes outer surface 37.

Fig. 3 shows the first embodiment of first sensor 32.First sensor 32 includes two coils, described two lines Circle is intersected with each other to be placed and with angle [alpha].

Fig. 4 and Fig. 5 show the second embodiment of first sensor 32.First sensor includes two be generally orthogonal to one another Individual coil is orientated and position to be set up on six-freedom degree.First coil can have taking along the length of implant 30 To.Second coil can be configured to the orientation of the circumference wound on implant, and the winding is e.g. realized in the trench , or second coil can the orientation with the radius along implant 30.Although in addition, it is preferred that make coil perpendicular to one another, Other orientations can also be used, but mathematically may be increasingly complex.Further, coil can be configured to spiral about The orientation of implant 30.This orientation can allow two coils to be placed perpendicular to each other, and two coils are both along implant Length is placed along the circumference of implant 30 again.

Fig. 6-Fig. 8 shows the second embodiment of rectificating surgery implant component 60.Rectificating surgery implant component 60 is wrapped Include implant 30.In the embodiment illustrated in fig. 6, implant 30 includes the mark existed in the form of pierced holes 31.Implantation Thing 30 includes longitudinal internal groove 66 and dismountable lead 64.In the embodiment shown in fig. 8, longitudinal ditch as depicted The diameter of groove 66 is vertical with intubation 33；However, in other embodiments, the diameter of longitudinal internal groove is comprised in appearance Between face 37 and inner surface 35.Dismountable lead 64 includes being located at the first sensor 32 at its distal portions 65.This first Sensor 32 is known relative to the skew that mark 31 is formed.Implant shown in Fig. 6-Fig. 8 includes the material of bio-compatible Material, and can be metal alloy or polymer.Longitudinal groove 66 can be set by mach mode or the mode being molded Put and locate in position.

In use, the implant 30 with dismountable lead is installed in patient body.For example, in carrying out In the case that portion is fixed, intramedullary nail is placed in marrow inner catheter.Alternatively, piercing element, such as screw, so as to head can be used in user The near-end of first locking of intramedullary nails.Due to the position of longitudinal groove 66, therefore dismountable 64 pairs of lead locking of intramedullary nails first Near-end produces interference.Operator is using target locating set 18 and first sensor 32 to recognize mark 31.For example, for entering For the situation of row Intramedullary nailing, surgeon is pierced through blind hole and drills through the hole using target locating set 18 to recognize To place piercing element.After implant 30 is by fixation, operator removes dismountable lead 64 and abandoned.

Fig. 9 further illustrates a specific embodiment of marker recognition device 18 as shown in Figure 1.In the specific embodiment In, the marker recognition device 18 includes sensor 20, serrated tip 22, pipeline 24 and handle 26.Drilling tool 90 has mark 92, described Mark interacts with mark sensor 19, and the mark sensor is adjacent with pipeline 24.This interaction and a pair of numerals The similarity of formula measurement slide calliper rule is：Position between mark 92 and sensor 19 is equal to a certain distance.Using this Distance is to determine depth that drilling tool is pierced in bone and finally to determine the length for the nail being inserted into the hole got out.Only work as biography When sensor 92 and 19 is closely adjacent one another, i.e., only it can just obtain range reading or drilling when drilling tool 90 is located at 24 inside of pipeline Depth reading.It is to license to Sasaki etc. United States Patent (USP) No. 6,675,491 on January 13rd, 2004 and in August 7 in 2007 Day licenses in Me etc. United States Patent (USP) No. 7,253,611 and describes typical measurement apparatus, and each patent is herein It is cited as reference.In the embodiment shown, mark sensor 19 is connected to communication module 21.Another optional mode It is that mark sensor 19 can be connected to processor 12 by wired mode.In fig .9, communication module 21 includes being used to be electrically connected It is connected to the 3rd sensor 23 of processor 12.The other embodiments of marker recognition device are shown in Figure 32-34.

Figure 10-Figure 12 show for by implant 30 be electrically connected to insertion handle 40 typical method, the implant and Insertion handle has corresponding Electical connector.In Fig. 10, biasing element 72 makes contact device 70 be biased towards insertion handle 40. In fig. 11, the flexible Electical connector 74 of implant 30.In fig. 12, extend between lead 50 and another part Metal wire in the cockle of joint 76 together.In one approach, metal wire is to exempt to tear（torn free）And it is being mounted with Separated after rectificating surgery implant component 28 in joint 76.In another method, orthopaedic srugery's implantation is being mounted with After thing component 28, in the top of the joint 76 cutting metal wire.In Figure 12 B and 12C, two pieces of flexed plates 53 by one or Multiple pads 57 are soldered together wire harness 55 being connected to sensor.Wire harness 55 can be mounted to insertion handle 40 In the intubation for going up or being installed in insertion handle 40.In the illustrated embodiment, four pads 57 are soldered together.Locking Tab 59 is sandwiched between implant 30 and insertion handle 40, so as to be resistant to the abrasion and stretching related to implant insertion.Once Insertion handle is removed, and wire harness 55 can be pulled so that pulling out the incompatible material of all biologies therewith.In fig. 12d, Ring 61,63 is connected in the fabrication process.After the implants, there is the metal wire 67 of set by pulling, ring 61,63 is removed.

Referring now to Figure 13 A and 13B, implant 30 and/or insertion handle 40 may include one or more Hes of alignment feature 44 Recess 80 with matching, or may include alignment pin 46 and hole with matching 82.Insertion handle may be constructed such that with The upper surface alignment of implant.In one embodiment, insertion handle can have keyway, and the keyway is configured so as to plant with being located at The slit entered on thing is engaged.Other alignment guides can be used.In addition, guide device can have electric connector, the electricity Connector is configured so as to be engaged with the electric connector on implant.Attachment means between guide device and implant can be with It is spring-loaded device, to ensure to realize electrical contact between electrical.In order to avoid guide device and implant it Between attachment means occur short circuit, can to electric connector carry out insulated maintaining.The another of implant is electrically connected to as by insertion handle One example, electric connector may include post and slip ring.Ring can be located on implant, and post is located on insertion handle.The post biased with Just contacted with ring.In such an embodiment, insertion handle is not fixed relative to the angle position of implant axis.This causes nothing By with what kind of angle position, insertion handle can be all positioned relative to implant.

In another embodiment shown in Figure 13 B, implant 30 and/or insertion handle 40 may include one or more alignment pins 47 and hole with matching 83.Alignment pin 47 can be the needle-valve point pin for being designed specifically for realizing single engagement, and split Except when, the pin retained part of implant removes the incompatible material of all biologies therewith.

Any electric connector mentioned above may include the memory storage for the shift value calibrated for storage sensors Device（Not shown in figure）.

Referring now to Figure 14, implant 30 and insertion handle 40 can be sized, even if so that when to part When being assembled or being coordinated, the space of first connector 52 is still available for.

As example, it can be used for recognizing the system of mark so as to the screw blind hole for the intramedullary nail being implanted progress mesh Demarcate position.The intramedullary nail is implanted in patient body.Electromagnetic field generator is activated.Processor, which receives to come from, is installed to intramedullary nail On sensor signal and signal from the sensor being installed on marker recognition device, the marker recognition device is, for example, Drill sleeve.The computer program run on a processor uses the information of at least two sensors and graphically existed The relative position of at least two sensor is shown on monitor.Surgeon uses the feedback provided by processor to make mark Identifier movement is in place.When marker recognition device is in place place, surgeon drills through bone and intramedullary nail to be formed Screw hole.In certain embodiments, processor can provide the related feedback of depth in the hole to being drilled.Surgeon then may be used Make screw attached solid to be carried out to the blind hole of intramedullary nail through the hole that this is drilled.

Figure 15 shows the second embodiment of the system 110 for recognizing mark.System 110 includes processor 112, mark Identifier 118 and rectificating surgery implant component 128.In certain embodiments, system 110 further comprises the He of monitor 114 Insert handle 140.

Marker recognition device 118 is used to carry out target positioning to mark.Marker recognition device 118 includes 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, second sensor 120 is arranged under certain orientation relative to the axis of pipeline, and the pipeline can be received Drilling tool.Sensor make it that the position of the pipeline can be relative to another in conveyer or system relative to this skew that pipeline is formed One sensor and in six sizes（Three translation sizes and three Angular Dimensions）On be located in space.In some embodiments In, it may be necessary to it is calibrated to adjust the offset distance of second sensor 20 to processor.

Rectificating surgery implant component 128 includes implant 130 and magnet 132.The magnet can be permanent magnet or electromagnetism Body.Magnet 132 is configured to certain orientation relative to the mark on implant 130 and is located at pre-position.Magnet relative to This skew that mark is formed make it that the position of the mark can be relative to another sensor in conveyer or system at six Size（Three translation sizes and three Angular Dimensions）On be located in space, another sensor is, for example, the second sensing Device.In some embodiments, it may be desired to be calibrated to adjust the offset distance of magnet 132 to processor 12.In such as Fig. 1 In shown embodiment, implant 130 further comprises recess 136 and lid 138.For when electromagnet, lead 150 It is connected to magnet 132 and is comprised in groove 134.

As example, it can be used for recognizing the system of mark so as to the screw blind hole for the intramedullary nail being implanted progress mesh Demarcate position.The intramedullary nail is implanted in patient body.Processor receives the letter from the sensor being installed on marker recognition device Number, the marker recognition device is, for example, drill sleeve.The computer run on a processor using sensor information and with The mode of figure shows relative position of the sensor relative to the magnet on a monitor.Surgeon is used by processor The feedback of offer makes the movement of marker recognition device in place.When marker recognition device is in place place, surgeon drills through bone With intramedullary nail to form screw hole.In certain embodiments, processor can provide related anti-of depth in the hole to being drilled Feedback.Surgeon can then make screw attached solid to be carried out to the blind hole of intramedullary nail through the hole that this is drilled.

Figure 16 shows a kind of method for being used to select the visual field corresponding with marker recognition device position.In some embodiments In, the visual field of display on a monitor depends on position of the marker recognition device relative to implant.The diameter of implant is divided into Multiple sectors or field domain.In embodiment as shown in figure 16, the diameter is divided into three field domains：（A）135 degree to 225 degree；（B）0 degree to 135 degree；With（C）225 degree to 360 degree.The initial visual field is based on marker recognition device taking relative to implant To.When user makes marker recognition device shift to implant or move away from implant, monitor is shown on selected field domain Region zoom in or out.

Figure 17 is for selecting the visual field and showing a flow chart marked.The process can be repeated constantly for multiple marks Carry out.The processor 12 uses transformation matrix in procedure below step.In step 200, the position based on related sensor Position of the marker recognition device relative to implant is calculated, and selects the mark closest to marker recognition device to display it. Limit the global visual field in step 210, the visual field show in the case where select mark is arranged on and is necessarily orientated in order to Whole implant in the case of appropriate observation.The global visual field and the situation in observation implant spaced apart position It is similar.In a step 220, determining whether there is multiple marks has identical orientation.If answer is yes, in step In 230, it is closest and select the mark to be observed that processor calculates which mark and the position of marker recognition device.If answered Case is no, then limits local field of view in step 240 and make the visual field centered on selection marquee.Local field of view with close The situation that the implant is observed at adjoining position is similar.In certain embodiments, may when limiting local field of view Wish to hide the marker recognition device.In step 250,260 and 270, processor 12 is identified from marker recognition device to the mark Distance, and hide according to the above-mentioned judgement made or be presented the marker recognition device.In step 250, mark is calculated to know Other device to the mark distance and by this calculate apart from D with setting variable T_{It is global}And T_{It is local}Compare.If D is more than T_{It is global}, then the global visual field is selected in step 260 and processor advances to step 285.If D is less than T_{It is local}, then in step 270 Selection local field of view simultaneously makes the visual field centered on the mark.Then, processor advances to step 275.In optional step 275 In, marker recognition device is hidden.Another way is, in step 280, based on the position of camera in the middle of being calculated apart from D, from And make it possible to carry out smooth transition from the global visual field to local field of view.In step 285, marker recognition device is presented out Come.There is provided the scene with selected position of camera in step 290.

Figure 18 schematically shows the first alternative for making marker recognition device align.It can be used and run on a processor Computer program obtain at least two sensor information and to graphically on a monitor described in display at least The relative position of two sensors（Relative position of the second sensor relative to the first sensor）.This causes user to make With the placement of the System guides marker recognition device.In the case where drilling goes out intramedullary nail blind hole, System guides user is bored Have laying and subsequently appropriately drilling through the hole in the intramedullary nail for sleeve.Patterned user interface may include for it is each from The alignment guide mark provided by degree.The alignment level of bottom line can be set, so that surgeon continues to marker recognition Device is oriented, until each free degree meets the alignment level of bottom line, so that effectively placement markers identifier.Figure Example shown in 18 gives such a case, wherein the tracking of the bottom line needed for being met along the placement of Y-direction is pacified Put.However, other translation freedoms or rotary freedom all do not meet the demand of the bottom line.Although with column diagram in figure Mode show tracking amplitude, but other graphical representations modes, such as color coding can also be used.

Figure 19 schematically shows the second alternative for making marker recognition device align.In this embodiment, using many The graphic interface that individual LED is positioned to drilling tool can be placed on marker recognition device, and the marker recognition device is, for example, drilling tool Sleeve.Trackization is carried out by using LED to drilling tool to follow the trail of, surgeon can make drilling tool align with fixed blind hole.In addition, the rail Mark it is also possible to use secondary display to increase more information for system.For example, in order to influence the amplitude of accommodation, the track may include Flash LED, so that the flicker of high frequency needs regulation by a larger margin, and low frequency flicker can then need tune more by a small margin Section.Similarly, color can increase the information related in order to realize the regulation alignd and carried out.

Figure 20 shows the exemplary view of monitor.Part I 500 shows the brill carried out on every side of implant Cut distance.This causes user to be best understood from drilling depth and be sent out in the case where reaching appropriate drilling depth to user Go out the alarm when stopped.Part II 510 has provided the user alignment information.As an example, it can be used as shown in Figure 9 Embodiment obtain drilling depth data.

Figure 21 shows another alternative embodiment of marker recognition device.The marker recognition device is configured to will pass through LED and shown Position and trace information are shown to realize appropriate alignment.LED size can show related to the required amplitude of accommodation attached Plus information.The track lamp can show the simple toggle switch between the track of alignment and unjustified track.As another One example, can be color coded the suggestion so as to the amplitude of accommodation needed for providing to realize appropriate alignment to track LED.

Figure 22 shows the first alternative embodiment of insertion handle 700.The insertion handle 700 includes arcuate slot 710.The arch Slit limits 18,118 movement in operating space of marker recognition device., should in the case where screw blind hole is identified Arcuate slot limits the movement of drill sleeve to carry out accurate adjustment to its position.In certain embodiments, handle 700 is inserted Including support 712, the support receives marker recognition device and advanced in slit 710.

Figure 23 shows the 3rd embodiment of the system for recognizing mark.In this embodiment, rectificating surgery implant 800 be hone lamella and insertion handle 810 is by the attached guide device being affixed on the hone lamella.In the embodiment shown, inductance sensor phase It is placed in for one or more marks on the surface of rectificating surgery implant 800.Guide device 810 causes marker recognition device 818 can be translated and/or be rotated relative to guide device, so that marker recognition device suitably aligns with mark 802, the mark Note for example, fastener hole.In addition, for when setting multiple fixing holes over the implant, being set in guide device 810 The additional bullport 812 put can help to the position close to additional fixing hole.

Figure 24 shows the second alternative embodiment of insertion handle.The insertion handle 900 is included by using small servo motor 920th, 922, the position of 924 pairs of marker recognition devices 918 carries out accurate adjustment.Servo motor 920,922,924 can be to marker recognition The orientation of device 918 and position are adjusted.By automated manner or the servo motor can be controlled by surgeon.

Figure 25 shows bone 100 and for the 3rd embodiment for the system 1010 for recognizing mark.System 1010 includes control Unit 1012, field generator 1014, marker recognition device 1016, intramedullary nail 1024 and detector 1029.Marker recognition device 1016 Target locating set can be regarded as.Control unit 1012 can be included as processor described above a part or can be with It is a single unit.Intramedullary nail 1024 is inserted into bone 100, and intramedullary nail 1024 has hole or mark 1028.In figure Show in embodiment, field generator 1014 is electrically connected to control unit 1012.In the illustrated embodiment, insertion handle 1022 is removable It is attached to unloading above intramedullary nail 1024.Insert handle 1022 and/or intramedullary nail 1024 can be with intubation.In certain embodiments, Inserting handle 1022 includes 3rd sensor 1032.

Marker recognition device 1016 includes second sensor 1020.The bootable drill bit 1018 of marker recognition device 1016, and bore First 1018 can be connected to drilling tool（Not shown in figure）Above.By wired mode or wirelessly, second passes Sensor 1020 can be connected to control unit 1012.In certain embodiments, field generator 1014 can be directly installed on mark Remember above identifier 1016.

Detector 1029 includes wire 1030, band 1034 and backstop 1036.In the illustrated embodiment, band 1034 be can be from Sycamore, Illinois Ideal Industries, the 300 of 0.060 inch of wide 0.125 inch that Inc. is obtained is The stainless-steel roll band of row.However, it should be appreciated by those skilled in the art：Other materials and other sizes can also be used.Example Such as, the arrowband of any polymer, composite or metal is used as band 1034, it is preferred that using nonferrous metal.Laying Before entering in intramedullary nail 1024, band 1034 can be wound.May result in the band with 1034 winding has nature Curvature.In certain embodiments, band 1034 can have the orientation for participating in the band so that it is placed in inserting for intramedullary nail 1024 Rectangular geometry in pipe.Can also be using ellipse, square or circular geometry.In certain embodiments, it is golden Category silk 1030 can be operatively coupled on band 1034.For example, this process can be realized by using adhesive or fastener. It may include scale or locking key that the depth of the band is represented when being inserted into implant with 1034.

By wired mode or wirelessly, first sensor 1026 is connected to control unit 1012. In the illustrated embodiment, first sensor 1026 is connected by using wire 1030 and connector 1038.In some embodiments In, connector 1038 can be saved.First sensor 1026 can be connected to the distal end of band 1034, and backstop 1036 can be connected To the near-end of band 1034.

In certain embodiments, detector 1029 may include the sensor outer housing for covering first sensor 1026（In figure not Show）.The sensor outer housing can be attached to above band 1034.Sensor outer housing can be by nonferrous material such as polymer, compound Material or metal are made.The sensor outer housing may include appropriate strain relief to protect wire 1030 not answered masterpiece With.The sensor outer housing can be constructed and arranged to sufficiently large to keep first sensor 1026 and be constructed and arranged to foot Enough small intubations to fit through insertion handle or implant.In addition, the sensor outer housing can be constructed and arranged to long enough To allow by the bending section in intramedullary nail bending section, intramedullary nail arcuate section and/or pertinent instruments.The sensor outer housing Front end face and rear end face can be designed such that so that the sensor outer housing will not keep off or be stuck in inserting for the instrument or implant Pipe is above.

Backstop 1036 can be used for the placement for controlling sensor 1026.If the length of band 1034 is fixed and known from insertion handle End to hole 1028 distance, then the repeatably placement of first sensor 1026 can be realized.Band 1034 can have foot Enough long length, so that sensor 1026 aligns with hole 1028, adjacent to the hole 1028, or is produced from the hole 1028 Skew.

In certain embodiments, insertion handle 1022 can be saved.In such a case, it is possible to select different belt lengths.So that Obtain a part or the end of the jointing nail 1024 of backstop 1036.

Figure 26 shows the detailed view of intramedullary nail 1024, sensor 1026 and hole 1028.Sensor 1026 and hole 1028 Alignment, the neighbouring hole 1028, or produce skew from the hole 1028.In the illustrated embodiment, sensor 1026 is generally The neighbouring hole 1028.

In use, intramedullary nail 1024 is placed into bone 100.Insertion handle 1022 can be attached on intramedullary nail 1024 Face.Detector 1029 is fed through in the intubation for being intubated and entering intramedullary nail 1024 of insertion handle 1022 until backstop 1036 engagement insertion handles 1022.In a particular embodiment, wire 1030 is connected in control unit 1012, and is made Sensor 1026,1020 and 1032 is calibrated with control unit 1012.In certain embodiments, detector 1029 is being carried out It can be removed after calibration.If it were to be so, 3rd sensor 1032 and transformation matrix can be used to recognize second sensor 1020 relative position, thus marker recognition device 1016.Selectively, user can use piercing element, such as screw, so that The near-end of locking of intramedullary nails first.Operating personnel recognize mark using marker recognition device 1016 and first sensor 1026 1028.For example, in the case of Intramedullary nailing, surgeon is recognized blind pierced holes using marker recognition device 1016 and bored Cut through the hole to lay piercing element.

Figure 27 shows a packaging embodiment.Generally, intramedullary nail has to be sterilized before being implanted into.If Just sensor is being installed in intramedullary nail before being sterilized, then in sterilization process, particularly if sterilization process is related to And if radiation, sensor may lose its calibration degree.For example, γ radiation can be used for carrying out seal member such as sensor Sterilization.Implementation shown in Figure 27, which is illustrated while allowing to re-start calibration to sensor, keeps the sterile side of intramedullary nail Formula.Embodiment shown in Figure 27 includes the first packaging 1040, second and packs the 1042, first connector 1044, the second connector 1046 and cable 1048.In the illustrated embodiment, sensor（Not shown in figure）It is located at the first packaging 1040 with intramedullary nail 1024 It is interior.Another optional mode is that detector 1029 and sensor are located in the first packaging 1040.In another example, only sense Device is located in the first packaging 1040.Memory storage（Not shown in figure）Sensor can be connected to.Memory storage can be used for storage Deposit calibration transfer matrix（x1,y1,z1,x2,y2,z2）And other data, the length and size of such as intramedullary nail or detector. Memory storage can be mounted or be placed in above intramedullary nail 1024 or detector 1029.First connector 1044 is electrically connected, But it is detachably attached, to above the second connector 1046.First connector 1044 is also electrically connected to sensor or memory Above device.First packaging 1040 keeps the device in it sterile.Cable 1048 is electrically connected to the second connector 1046 and note Recall device（Not shown in figure）.Calibration for the sensor is downloaded above storage device and by connector 1044, 1046 transmit to sensor and memory storage.Calibration step is can perform before implantation implant in the fabrication process or just Suddenly.

Figure 28 shows the method that the system 1010 is connected to network.Figure 28 shows network 1060, computing device 1050th, cable 1048, the second connector 1046, the first connector 1044 and intramedullary nail 1024.In the illustrated embodiment, sensor （Not shown in figure）In intramedullary nail 1024.Another optional mode is that sensor can be attached to above detector 1029 It is either freestanding.In certain embodiments, intramedullary nail 1024 can be enclosed in the packaging of packaging such as first 1040 and/or second In packaging 1042, but also not always so.Memory storage（Not shown in figure）Sensor can be connected to.Memory storage（Figure Not shown in）Sensor can be connected to.Memory storage can be used for storing calibration transfer matrix（x1,y1,z1,x2,y2,z2） And other data, the length and size of such as intramedullary nail or detector.Memory storage can be mounted or be placed in intramedullary nail 1024 or detector 1029 above.Network 1060 can be LAN or wide area network.Computing device 1054 is connected to network In 1060.In certain embodiments, network service can be encrypted.By using connector 1044,1046, cable 1048 will Computing device 1054 is connected to above sensor or memory storage.In this manner it is achieved that the calibration of the sensor can be from calculating Device 1054 and/or network 1060 are downloaded above.Although showing that sensor is located in intramedullary nail in diagram embodiment, also simultaneously Not always so.Sensor can be attached to above detector either freestanding.In certain embodiments, memory storage can In control unit, and control unit is connected to network so as to download calibration data.

Figure 29 shows the fourth embodiment of the system 1110 for recognizing mark.System 1110 includes control unit 1112nd, field generator 1114, marker recognition device 1116, intramedullary nail 1124, stop 1136 and detector 1129.Control unit 1112 It a part for processor described above can be included as or can be a single unit.Intramedullary nail 1124 is inserted into In bone 100, and intramedullary nail 1124 has hole or mark 1128.In the illustrated embodiment, by wired mode or logical Wireless mode is crossed, field generator 1114 is electrically connected to control unit 1112.In the illustrated embodiment, insertion handle 1122 is removable It is attached to unloading above intramedullary nail 1124.Insert handle 1122 and/or intramedullary nail 1124 can be with intubation.In certain embodiments, Inserting handle 1122 includes 3rd sensor 1144.Stop 1136 may include the 4th sensor 1139.

Marker recognition device 1116 includes second sensor 1120.The bootable drill bit 1018 of marker recognition device 1116, and bore First 1018 can be connected to drilling tool（Not shown in figure）Above.By wired mode or wirelessly, second passes Sensor 1120 can be connected to control unit 1112.In certain embodiments, field generator 1114 can be directly installed on mark Remember above identifier 1116.

Detector 1129 includes wire 1130, band 1134 and backstop 1136.In certain embodiments, band 1134 can have The orientation of the band is participated in so that it is placed in the rectangular geometry in the intubation of intramedullary nail 1124.In some embodiments In, wire 1130 can be operatively coupled on band 1134.For example, this can be realized by using adhesive or fastener Process.By wired mode or wirelessly, first sensor 1126 is connected to control unit 1112.In figure Show in embodiment, first sensor 1126 is connected by using wire 1130.In certain embodiments, it can be used separable Connector.First sensor 1126 can be connected to the distal end of band 1134, and backstop 1136 can be connected to the near of band 1134 End.Backstop 1136 can be used for the placement for controlling sensor 1126.If the length of band 1134 is fixed and the known end from insertion handle Distance of the portion to mark 1128, then the repeatably placement of first sensor 1126 can be realized.Band 1134 can have enough Long length, so that sensor 1126 aligns with mark 1128, the neighbouring mark 1128, or from the mark 1128 Produce skew.

In use, intramedullary nail 1124 is placed into bone 100.Insertion handle 1122 can be attached on intramedullary nail 1124 Face.Detector 1129 is fed through insertion handle 1122 and entered in intramedullary nail 1124 until the engagement insertion handle of backstop 1136 1122.In a particular embodiment, wire 1130 is connected in control unit 1112, and uses control unit 1112 Sensor 1126,1120 and 1132 is calibrated.In certain embodiments, detector 1129 can be split after being calibrated Remove.If it were to be so, the sensor 1139 of 3rd sensor 1132 and/or the 4th and transformation matrix can be used to recognize second The relative position of sensor 1120, thus target locating set 1116.Selectively, user can use piercing element, for example Screw, so that the near-end of locking of intramedullary nails first.Operating personnel are known using marker recognition device 1116 and first sensor 1126 Not other mark 1128.For example, in the case of Intramedullary nailing, surgeon recognizes blind pierced holes using marker recognition device 1116 And drilling is through the hole to lay piercing element.

Figure 30 shows the first method for being marked using the system identification.This method is since step 1210. In step 1212, sensor is placed in nail.In step 1214, insertion handle, which is connected to, to be nailed on, and stop is attached Onto 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 is recorded Come.In step 1224, from nailing on face removal sensor.In step 1226, nail is implanted in bone.In step 1228, Drilled using target locating set.This method ends at step 1230.

Figure 31 shows the second method for being marked using the system identification.In step 1310, tracing system quilt Connect.In step 1312, intramedullary nail is inserted into a bone.In step 1314, detector is inserted into precalculated position and orientation In intramedullary nail pipeline., it is necessary to judge that intramedullary nail is to need to carry out near-end locking before distal end in step 1316.If Words, then in step 1326, stop, which is attached to, to be nailed on.In step 1328, the skew between calculating detector and stop Amount.In other words, transformation matrix is produced.Another optional mode is that stop is not connected with intramedullary nail, but slotting using being installed in Enter the sensor in handle to calculate offset.In step 1330, detector is removed from the face that nails on.It is described in step 1334 Nail is locked by near-end.This process by using marker recognition device, mechanical clamp or can be manually operated and be achieved. In step 1336, marker recognition device is used to carry out target positioning to drilling tool.In step 1338, get out for distal screw Hole.In step 1340, intramedullary nail is by far-end locking.On the other hand, if it is determined that if carrying out far-end locking first, then In step 1318, marker recognition device and detector are used to carry out target positioning to drill bit.In step 1320, get out for remote Hold the hole of screw.In step 1322, intramedullary nail is by far-end locking.In step 1324, detector is removed above intramedullary nail. In step 1324, intramedullary nail is locked by near-end.This process can be by using marker recognition device, mechanical clamp or by manual Operate and be achieved.

Figure 32 shows a kind of system for being used to measure drill bit placement depth.System 1400 includes stator 1410 and slided Part 1412.Stator 1410 and sliding part 1412, which are formd, can sense the capacitive array of relative motion.Make stator 1410 Carry out the distance that linear movement can cause can be interpreted and be used to determine to have advanced relative to each other with sliding part 1412 Voltage pulsation.In certain embodiments, electronic measurement circuit（Not shown in figure）Marker recognition can be housed in sliding part 1412 In device, and drill bit can be specially constructed into the stator 1410 along outer surface, so that stator 1410 and slip Part 1412 is very linear close to each other.Sensing generation can in sliding part 1412 is received for the linear movement of drill bit stator 1410 It is interpreted the voltage of the range measurements of electronic measurement circuit.The range measurements can be sent to control unit and/ Or be shown on a monitor.Capacitance sensor is very sensitive for moisture, therefore some embodiments can be used for preventing liquid example As body fluid flows between stator 1410 and sliding part 1412.O-ring can be combined in marker recognition device or some are other The wiper of similar type, to keep drill bit to be substantially dry.

Figure 33 A and 33B show another system for being used to measure drill bit placement depth.System 1500 includes reflection code-disc Or bar 1510, lens 1512 and encoder 1514.Lens 1512 are by light focusing on code-bar 1510.With code-bar 1510 Rotated, the alternating pattern of the light projected respectively by window and code-bar falls on the photodiode of encoder 1514 Face.Encoder 1514 by the pattern transformation into represent code-bar linear movement numeral output.In the illustrated embodiment, it is used Encoder is can be obtained from 350 W Trimble Road, San Jose, California Avago Technologies AEDR-8300 type reflective optical encoders.Another optional mode is can also to use Avago Technologies The LED-based navigation system of ADNS-5000 One Chip USB.Encoder and its support electronic installation may be mounted to that mark Inside identifier, so that its input area is orientated " window " in being intubated towards marker recognition device.Mark, such as dark is same Thimble or light tone tore of reflection can be added to above drill bit, to strengthen visibility of the drill bit relative to encoder.These marks Can also be to indicate the beginning zero point for measurement.As drill bit is linearly moved in marker recognition device, encoder is surveyed Measure the movement of the drill bit.The range measurements can be sent to control unit and/or be shown on a monitor.

Figure 34 shows another system for measuring drilling depth.System 1600 has used linear variable differential transformation Device（LVDT）1612.Linear variable difference transformer is a kind of transformer for being used to measure linear displacement.Linear variable differential becomes Depressor 1612 includes multiple end-to-end magnetic plugs 1618 laid around pipeline 1610, and it is in the illustrated embodiment mark Remember identifier.In the embodiment shown in Figure 34, centering coil is primary coil, and two coils of outside are secondary coils.Circle Such as drill bit of ferromagnetic core 1610 of cylindricality enters line slip along the axis of pipeline.Alternating current 1614 is driven through primary line Circle, causes proportionally to sense generation voltage with its mutual inductance with primary coil in each secondary coil.Pickup is passed Sensor 1616 measures the size of output voltage, the distance that the output voltage is moved with fuse（It is up to its extreme limit of travel）Into Direct ratio.The phase of voltage represents the direction of the displacement.Because sliding core does not contact the inside of pipeline, therefore it can be without friction Under conditions of move so that linear variable difference transformer turn into a kind of highly reliable device.There is no any slip Or rotating contact causes linear variable difference transformer to be completely sealed relative to environment.The range measurements can be sent To control unit and/or it is shown on a monitor.

Figure 35-37 shows insertion handle 1700 and adjustable backstop 1800.Inserting handle 1700 has in end portion office 1712 with implant such as intramedullary nail（Not shown in figure）Connected drill steel 1710.Insertion handle 1700 may include to be used to be attached to only Quick connector 1716 above shelves, near-end target locating set or some Other Instruments or equipment.Inserting handle includes top Part 1714, the top section may include hole and/or alignment feature.Adjustable backstop 1800 may include slit 1810, alignment Component 1812 and fastener hole 1814.

In the embodiment shown in Figure 35-37, adjustable backstop 1800 can be detachably attached to top section Above 1714.In certain embodiments, adjustable backstop can be integrally formed with insertion handle 1700.In other embodiments, it is adjustable Section backstop can be permanently attached is above insertion handle 1700.In the illustrated embodiment, alignment member 1812 is assemblied in the top Rotated in the alignment feature of portion part so as to prevent from can adjust backstop.Fastener（Not shown in figure）It can be placed through tight Gu device hole 1814 is inserted above handle 1700 so as to which adjustable backstop be attached to.Band 1034,1134 can be placed through slit 1810, through drill steel 1710 and enter intramedullary nail intubation in.Slit 1810 can have what the geometry with band matched Shape, so as to contribute to it to insert or prevent the band from rotating.Band 1034,1134 may include to be used to represent for given Mark, scale or the locking key of appropriate depth are represented for nail is long.In certain embodiments, can adjust backstop 1800 may include to be used for The locking mechanism of temporary transient locking strip 1034,1134 at certain depth（Not shown in figure）.Most simply, the locking mechanism can be with It is the fastener of frictional engagement band 1034,1134.

Figure 38 shows the method that calibration is used to recognize the system of mark.For the degree of accuracy, calibration is necessary. This method is since step 1900, and the step may include for the system energization.In step 1910, if packaging, from Detector and marker recognition device are removed in packaging, and detector and marker recognition device are scanned.In certain embodiments, Equally stop is scanned.The scanning may include to read bar code using bar code reader.The scanning is caused in step The system of this in 1912 fetches the offset sensor data corresponding with the bar code in inquiry table.The inquiry table can be local Or with network as internet is connected.Another optional mode is, detector and marker recognition device may include sequence number or Other unique identifiers, and unique identifier is used in combination with inquiry table so as to fetching offset sensor data. In step 1914, the offset sensor data are stored in the local memory of system.In step 1916, user relative to Implant lays detector and attempts to follow the trail of mark using marker recognition device.In step 1918, to judge whether that calibration is Correctly.If it does, this method ends at step 1920.Otherwise, new shift value is fetched in step 1912.

In a particular embodiment, the feedback information provided is selected from auditory information, visual information and tactile data.Listen Feel that feedback can be output by loudspeaker, headphone, ear bud or earphone.Using radio frequency or ground data transmission by having Line or wireless mode transmission auditory feedback signal.Visual feedback can pass through cathode-ray tube, liquid crystal display or plasma display Show that device is output.As example, visual feedback means may include that TV monitor, personal digital assistant or personal multi-media are played Device.Transmitted using radio frequency or ground data and visual feedback signal is transmitted by wired or wireless way.Touch feedback can lead to Gloves, utensil or carpet is crossed to be output.Transmitted using radio frequency or ground data and tactile is transmitted by wired or wireless way Feedback signal.

The present invention further comprises a kind of method for being used to recognize mark.It the described method comprises the following steps：There is provided orthopedic Surgical implant component, the rectangle implant component has rectificating surgery implant and dismountable lead, and the rectangle is planted Enter thing and have to be attached with magnetic transducing on longitudinal groove, dismountable lead and in the longitudinal groove, it is described to rectify Shape surgical implant has proximal part, distal portions and at least one mark on the distal portions；Rectified described In shape surgical implant component implantation；Element is will puncture through first in the proximal part；Use marker recognition At least one described mark is identified device；After it will puncture through element first in the proximal part, it will puncture through Element is mounted at least one described mark in the distal portions；And remove dismountable lead.Should Method make it that near-end locking can be carried out to the implant before far-end locking is carried out.This is an advantage over prior art One obvious advantage, because existing device needs to carry out far-end locking before near-end locking is carried out.

In the fabrication process, feasible system is calibrated before the implantation of implant after the distribution or just.Calibration Step is registering with computer-assisted surgery similar.May because of it is different the reason for and need to be calibrated.Example Such as, it may be desirable to carry out pick up calibration to be modified manufacturing tolerance.The system is based on CAD Model is designed, and calibration is used to lay sensor relative to each other exactly.The processor or control are single Member may include to be used to generate X, Y, Z, pitching（pitch）, side-sway（yaw）And rolling（roll）Shift value is so as to by the sensing Device is positioned in global coordinate system or simply laid relative to each other.In one embodiment, the system is in system Be produced and calibrated during making, and be assigned unique identifier, such as sequence number, colour coding, bar code or Person's radio frequency identification（RFID) label.If the system needs to be recalibrated, then or in part or on network Unique identifier can be used to fetch shift value.It is possible to further fetch other numbers using unique identifier According to the size or intramedullary nail and/or the length of detector of such as intramedullary nail.

It can see by description above：Multiple advantages are realized and obtained by the present invention.

The embodiment for selecting and describing above be intended to the present invention principle and its practical application most preferably illustrated, by This enables one of ordinary skill in the art in the best way using multiple embodiments of the invention, and it is envisioned that is used suitable for specific The various modifications on way.

Due to that can make many to the construction and method for being described herein and illustrating in the case of without departing from the scope of the present invention The all the elements for including or being shown in the drawings in kind of modification, therefore description above should be interpreted exemplary rather than limit Property processed.For example, although fig 1 illustrate that for by the attached recess being affixed on implant of first sensor, but can also be used other Structure and/or method by these objects it is attached it is solid together.Therefore, range of the invention and scope should not necessarily be limited by any of above typical case Any embodiment in embodiment, but should be according only to appended claims below and its equivalents range And scope.

Claims

1. a kind of be used to guide the detector for placing identifier relative to rectificating surgery implant, including：

Elongated member, it includes anti-rotational feature, and the anti-rotational feature includes the non-circular cross sections shape of the elongated member Shape, wherein the elongated member is configured to engage backstop at any place of multiple points of the length along the elongated member, with And its described in elongated member at least a portion have along the elongated member length natural curvature, the elongated member Part be configured to when the elongated member through slot acceptance in the backstop when limitation elongated member relative to the backstop rotation Turn, the backstop has the non-circular transverse cross-section for the non-circular transverse cross-section for matching the elongated member substantially；And

It is connected to the magnetic sensor of the elongated member；

Wherein described elongated member includes mark, scale or the locking key along the length of the elongated member, the mark, scale Or at least one of locking key indicates the position of length thereof of the elongated member between the backstop and the magnetic sensor Put, being designed and sized to for the length thereof will be described when in the passage that the detector is inserted into the rectificating surgery implant Magnetic sensor is placed on known location relative to the mark of the rectificating surgery implant.

2. detector as claimed in claim 1, wherein：

The elongated member has proximally and distally；

The magnetic sensor is connected to the distal end of the elongated member；And

The elongated member is flexible thin component.

3. detector as claimed in claim 1, wherein, when the backstop is located at indicating positions, the elongated member is in institute The length thereof between backstop and the magnetic sensor is stated to be designed and sized to when the backstop engages orthopaedic srugery's implantation The magnetic sensor is placed on the known location during end of thing.

4. detector as claimed in claim 1, wherein, when the backstop is located at indicating positions, the elongated member is in institute The length thereof between backstop and the magnetic sensor is stated to be designed and sized to when backstop engagement and the detector are independent Insertion handle specific part when the magnetic sensor is placed on the known location.

5. detector as claimed in claim 4, wherein, the length thereof of the elongated member is dimensioned such that, in institute State in the known placement of magnetic sensor, the elongated member extends through the passage of the insertion handle and extends into described rectify The passage of shape surgical implant, the elongated member may move through the passage of the insertion handle.

6. detector as claimed in claim 1, wherein, when the backstop is located at indicating positions, the elongated member is in institute The length thereof stated between backstop and the magnetic sensor is dimensioned such that, is being placed known to the magnetic sensor In, the magnetic sensor aligns with the hole being limited in the rectificating surgery implant, or neighbouring hole alignment.

7. detector as claimed in claim 1, wherein the elongated member has longitudinal axis, wherein the anti-rotational feature It is rectangle, oval or at least one of square cross section to have including the elongated member perpendicular to the longitudinal axis.

8. detector as claimed in claim 1, wherein the elongated member is included with the elongated member described orthopedic outer The corresponding locking key of specific insertion depth in the passage of surgical implant.

9. detector as claimed in claim 1, wherein the elongated member has a longitudinal extent, and the elongated member Non-circular transverse cross-section continuously extends along the whole longitudinal extent of the elongated member.

10. detector as claimed in claim 1, wherein the anti-rotational feature be configured to limit the elongated member with Rotation in the passage of circular cross section.

11. detector as claimed in claim 1, wherein the rectificating surgery implant is the intramedullary nail with length-specific, And with the elongated member on an instruction elongated member in the mark, scale or locking key on the elongated member The corresponding position of proper placement depth, target positioning is carried out with the mark with the length-specific to the intramedullary nail.

12. with the elongated member on an instruction elongated member in detector as claimed in claim 8, wherein locking key The corresponding position of proper placement depth of part, target is carried out with the mark with length-specific to the rectificating surgery implant Positioning.

13. detector as claimed in claim 1, includes the storage device of the calibration data of the storage magnetic sensor.

14. a kind of system, including：

Rectificating surgery implant, it has mark and passage, and the proximal end region of the passage has circular cross section, the passage With near-end；

Identity recognizer；

Detector, it is configured to be inserted into the near-end of the passage, and the detector includes magnetic field sensor and elongated member Part, the elongated member is configured to the magnetic field when in the passage that the detector is inserted into the rectificating surgery implant Sensor is placed on the known location relative to the mark, and at least a portion of the elongated member is extended along a longitudinal axis simultaneously With the natural curvature along the longitudinal axis, and the elongated member includes anti-rotational feature, and it is described that it is configured to limitation Elongated member the region with circular cross section rotation, wherein the anti-rotational feature of the detector include it is described thin The non-circular transverse cross-section of long element, the anti-rotational feature is configured to limit the elongated member to be inserted in the detector The near-end of the passage rotates when neutralizing by having the proximal end region of circular cross-section；

Backstop, its adjustable length along the elongated member, the backstop limits slit, and the slit has basic matching described The non-circular transverse cross-section of the non-circular transverse cross-section of elongated member, it is described orthopedic outer that the backstop is configured to engagement The near-end of surgical implant；And

Control unit, it is operably connected to the identity recognizer and the magnetic field sensor,

The system configuration is put into the passage neutralization for causing the sensor when the detector to be located at the rectificating surgery implant Put in the precalculated position relative to the mark, the system can be used the guiding identity recognizer relative to the mark The placement of knowledge.

15. system as claimed in claim 14, wherein the rectificating surgery implant is intramedullary nail, and wherein described elongated member Part is flexible thin component.

16. system as claimed in claim 14, wherein the elongated member includes metal tape and the elongated member is with vertical To axis, and wherein described anti-rotational feature includes the metal tape and had perpendicular to the generally rectangular horizontal stroke of the longitudinal axis Section.

17. system as claimed in claim 14, wherein the elongated member includes indicating the elongated member described orthopedic Mark, scale or the locking key of insertion depth in the passage of surgical implant.

18. system as claimed in claim 14, wherein the elongated member is between the backstop and the magnetic field sensor Length thereof be designed and sized to the magnetic field when in the passage that the detector is inserted into the rectificating surgery implant Sensor is placed on the known location of the mark relative to the rectificating surgery implant.

19. system as claimed in claim 15, in addition to it is installed to the storage device of the intramedullary nail or the detector, institute State the calibration data that storage device stores the magnetic field sensor.

20. system as claimed in claim 19, wherein the storage device also stores the instruction intramedullary nail or the detection The length of device or the data of size.

21. system as claimed in claim 14, wherein the backstop include being configured to engaging the rectificating surgery implant or Handle is inserted to limit the alignment characteristicses of rotation of the backstop relative to the rectificating surgery implant；And

Wherein described backstop has the hole for being defined through the backstop, and the hole is biased from the slit.

22. system as claimed in claim 14, wherein the backstop includes locking mechanism, it is configured to adjustably keep institute State the position of length of the backstop along the elongated member.