CN106659524B - For executing the patient's matching type instrument and method of surgical operation - Google PatentsFor executing the patient's matching type instrument and method of surgical operation Download PDF
- Publication number
- CN106659524B CN106659524B CN201580041253.6A CN201580041253A CN106659524B CN 106659524 B CN106659524 B CN 106659524B CN 201580041253 A CN201580041253 A CN 201580041253A CN 106659524 B CN106659524 B CN 106659524B
- Prior art keywords
- guiding piece
- surgical device
- Prior art date
Present disclosure is related to field of medical devices and generally directed to can be configured to the unique anatomical feature based on patient The instrument that uses in surgical facilities for particular patient, and production and preparation method thereof.
Cross reference to related applications
The application is the part continuation application for the U.S. Patent Application No. 13/841,069 submitted on March 15th, 2013.This Apply for what the U.S. Provisional Patent Application No. for also requiring on June 7th, 2013 to submit was submitted on July 12nd, 61/832,583,2013 On September 13rd, 61/845,463 and 2,013 61/877,837 priority submitted.These applications are by quoting with its whole Content is incorporated herein.
Complexity and different tools used in these operations, instrument, implantation material in view of surgical operation and its His device, and the anatomical discrepancies of the variation between the patient of those tools, instrument, implantation material and device are received, for It is usually to have challenge that creation, which considers the unique of specific patient and the surgical operation plan of irregular anatomical features sometimes,. For example, being implanted into pedicle screw (as adjunct or independent stabilizing mechanism) in centrum is treating a variety of different backbones Be widely accepted in the surgeon of disease, although and the performances of a variety of different vertebral pedicle bolt structures become can be pre- It surveys, but multiple challenges is still had for the placement and insertion of these pedicle screws or other bone anchors.These challenges appear in Since pervious surgical operation prevents surgeon to exist from the anatomical configurations (anatomy) referring to bony landmark or patient When irregular in shape.
Present surgeon, which has, easily turns magnetic resonance imaging (MRI) data or computer tomography (CT) data It changes by the ability of the readable data set of CAD (CAD) program and/or finite element modeling (FEM) program, then The data set can be used to create such as customized implants, which is the dynamic based on anatomical structure associated therewith Property.Although this data are used by the surgeon at present in surgery surgery planning, largely not yet The instrument or other surgical devices complementary with the unique anatomical of patient construction are designed to for create a set of customization.
The prior art fails to teach a kind of for creating a set of surgical instruments based on the data set for being originated from MRI or CT scan System.It adapts to for example, can permit surgeon using patient specific data's collection for centrum in plate or other bone anchors The slight change of position and orientation aspect, to avoid specific skeletal anatomy construction or in the positioning and alignment of adjacent centrum In scrambling.As another example, can be selected with assisted surgery doctor for implantable device using these data sets Desired track is selected, to avoid crossing over pedicle wall for example in actual operation and destroying canalis spinalis.Use these data sets Surgeon is allowed to pass through the tool and instrument of creation customization to avoid these type of errors, these tools and instrument may include Orientation, end stop member or other security-related features to avoid any implantable device over-torque and excessively insert Enter.These data sets also allow for one or more anatomical features that surgeon's creation is oriented to is represented by the data set The patient contact surfaces that match and thus with position appropriate and orientation quickly and to effectively position and place this or Multiple patient contact surfaces.
It would thus be advantageous to provide the instrument suitable for surgical operation, which is adapted to and/or is configured to And/or multiple anatomical features of specific patient can be complied with and/or comply with one or more other instruments, it is outer to assist Section doctor securely and effectively completes the one or more surgical operation, and additionally reduced significantly not eliminating with On these problems and risk for pointing out.By reading summary of the invention of the invention and part and appended claims being described in detail Book, other advantages better than the prior art will be known.
Summary of the invention
According to the one aspect of present disclosure, a kind of novel make in one or more surgical operations for developing is described The system and method for customizing instrument.According to the system and method use of this embodiment can be originated from capture MRI data or Patient's the unique form of CT or other data, to export one or more " patient's matching type " instruments, these instruments include being based on The complementary surface of multiple data points from MRI the or CT data.Each " patient's matching type " instrument is the solution around patient itself Construction, desired insertion track are cutd open (using 3D CAD software, for example in WO 2008027549 in being arranged in the preoperative The software of disclosure is verified, and the document is incorporated herein by quoting with entire contents) and according to a reality described herein It applies example and is wound on other instruments used in the surgical operation to match and orient.
It is wanted by the additional background of offer, context and the printed instructions for further satisfaction 35U.S.C. § 112 Ask, for explain small notch, small wound or Minimally Invasive Surgery (" MIS ") and further describe it is usually associated therewith these This has a definite purpose for different tools and other instruments, and following documents is incorporated herein by quoting with entire contents: being authorized The U.S. Patent number 6,309,395 of Smith et al.；Authorize the U.S. Patent number 6,142,998 of Smith et al.；It authorizes The U.S. Patent number 7,014,640 of Kemppanien et al.；Authorize the U.S. Patent number 7,406,775 of Funk et al.；It authorizes The U.S. Patent number 7,387,643 of Michelson；Authorize the U.S. Patent number 7,341,590 of Ferree；Authorize Michelson U.S. Patent number 7,288,093；Authorize the U.S. Patent number 7,207,992 of Ritland；Authorize the U.S. of Byrd III et al. The patent No. 7,077,864；Authorize the U.S. Patent number 7,025,769 of Ferree；Authorize the U.S. Patent number of Cornwall et al. 6,719,795；Authorize the U.S. Patent number 6,364,880 of Michelson；Authorize the U.S. Patent number 6,328,738 of Suddab； Authorize the U.S. Patent number 6,290,724 of Marino；Authorize the U.S. Patent number 6,113,602 of Sand；Authorize the beauty of Marino State's patent No. 6,030,401；Authorize the U.S. Patent number 5,865,846 of Bryan et al.；Authorize the United States Patent (USP) of Ojima et al. Numbers 5,569,246；Authorize the U.S. Patent number 5,527,312 of Ray；And authorize the U.S. Patent Application No. of Michelson 2008/0255564。
A variety of different surgical operations can be by the way that bar or plate, screw or other devices are introduced adjacent skeleton dissection Construction is learned to complete so that multiple and different parts of such as vertebra are linked to the corresponding part on adjacent vertebrae.MIS operation is logical Often carried out in the sacroiliac region domain of patient, lumbar vertebrae, thoracic vertebrae or cervical region.The MIS operation usually quilt carried out in this region It is designed to stop and/or eliminate all movements in the segment, this is by damaging some or all of joints in the segment simultaneously And adjacent vertebrae realization further is fastened using the implantable fixed device of bone grafting material and/or rigidity.It is moved by eliminating It is dynamic, it is possible to reduce or avoid backache and further degenerative disc disease.Fusion requires the tool for touching vertebra, Such as the surgery intubation for MIS operation, and other tools for being implanted into desired implantation material, bioactive materials.This A little tools, which usually require that, introduces additional tool to prepare the position for implantation.These tools may include bore, bore guiding piece, Debridement tool, device for casting, vice, fixture, intubation and other insertion/retraction tools.
Spinal surgery and other surgical operations can be carried out by a variety of different MIS operations, this with typically It is required that cutting muscle, general surgical procedures and the method difference boning and retract other natural elements.In the mistake of MIS operation Cheng Zhong implements to construct patient anatomy the approach with smaller breaking-up by using retractor tube or opening, this is utilized Anatomy and current techniques are to limit the damage to structure is intervened.
In the typical MIS operation carried out on backbone, bony landmark is established with fluoroscopy detection mode and at these Small notch is manufactured on mark.According to a variety of distinct methods known in the art, using a series of expanders until in the anatomy One or more intubations are placed in structure.In some operations, then microscope is placed on operative site to provide illumination With the amplification of the 3-D view to anatomical site, to ensure that surgeon can be accurately located desired patient anatomical It learns and constructs and be oriented properly and be oriented in any tool, instrument or other surgical devices used in MIS operation.However Microscope is expensive and not extensive device, it is desirable that surgical back and the uncomfortable revolution of neck progress are necessary to obtain View, and it is also troublesome thing (must be placed on big aseptic plastic bag in this eight feet of high structures) that covering, which is got up,. Due to microscopical size, also it is difficult using enough illuminations.
Progress MIS operation, the main hazard that intervertenral space is especially touched during epispinal MIS performs the operation are nothing Nerve by the contact of meaning ground or injury vertebra, including issue nerve root (exiting nerve root), passing nerve (traversing ) and cauda equina nerve (cauda equina) nerve.The accurate location of nerve cannot essence before starting operation by these vertebras Really determine and therefore depend on the ability that surgeon is subject to vision positioning after manufacturing initial incision to it.In addition, Intervertenral space in backbone has to be arranged in for be inserted into intervertebral region Surigical tool to be unable at the position of perfect forecast before Other Sensitive nerves.Correspondingly, the danger for pinching or damaging spinal nerve when touching intervertenral space is proved to be limited in very much micro- The method and apparatus used during wound spinal surgery.In addition, pass through patient back receive intubation when, such as when into When row Minimally invasive procedure is performed the operation, thus thin vessels rupture stops surgeon to see the intervertebral area being intubated after being inserted into Domain.Other anatomical features of specific patient may also interfere surgical sight or make it difficult to provide photograph in intubation It is bright.Therefore, the present disclosure specific disadvantage to be solved is to provide patient's matching type device to be not necessarily to microscope or other devices Promote to tool appropriate positioning and orientation and also eliminates problem associated with prior art MIS operation.
The advantages of surpassing the prior art is provided in terms of the matching of customization and the integration of this system disclosed at present, especially It is to thereby reduce the mistake in the one or more surgical operation by providing multiple interlockings and/or match point for each instrument In journey it is unjustified, misplace and a possibility that subsequent mistake.
Correspondingly, the one aspect of present disclosure is to provide a kind of method for being used to prepare customization surgical device or instrument, In preferred embodiment method includes the following steps:
Obtain data associated with the anatomical configurations of patient；
By data conversion obtained at one or more 3-D data sets；
At least one track or path are determined in order to execute surgical operation to the patient；
Determine at least one surface associated with the anatomical configurations of the patient；
Generate the three dimensional representation of the customization surgical device or instrument, the expression combine at least one track or path with And the match surface at least one surface associated with the anatomical configurations of the patient；And
The customization surgical device or instrument are made using the three-dimensional surface.
According to the other side of present disclosure, a kind of system and method for assisting one or more surgical operations include Following steps:
Data associated with the anatomical configurations of the patient are obtained by MRI or CT scan；
The MRI or CT scan data are converted into one or more 3-D data sets；
Determination will be configured for the device for assisting to need the one or more surgical operation for executing the patient Orientation one or more axis or plane；
Using identified axis and consider any other constraint for being originated from converted one or more data sets, To this for assisting the device of the one or more surgical operation to model；
The prototype of modeled device is generated by using rapid prototyping forming machine；And
The prototype is prepared for using during the one or more surgical operation.
As described above this aspect, consider be originated from converted one or more data sets any other about This method and step of beam may include: the size of the modeled device of adjustment to adapt to limit surgical space, it is right The element of the device modeled be oriented with avoid certain anatomical features, creation can be convenient in the one or more Associated one or more surfaces of one or more instrument and/or tool operation used in surgical operation, etc..
According to the yet other aspects of present disclosure, which includes use from radiophotography Imaging machine, fluorescence The data that spectroscopy, ultrasound machine or nuclear medicine scan device obtain.
On the other hand, these patient's matching characteristics can be confirmed by one or more other processes, such as Fluoroscopy or other processes well known by persons skilled in the art.
In the one aspect of present disclosure, this method includes using the bone obtained by the CT scan constructed to patient anatomy Density data is come for planning the track of surgical guidance part and corresponding fixed device or instrument, such as is intended to penetrate bone anatomy Cutting/path/borehole apparatus of construction.This data can be by it is considered herein that the other modes with description be come using outer to assist Section doctor plans the surgical operation of patient, visualizes or otherwise prepares.
It, can be with the data from bone density scan instrument to from the above description this again in another alternate embodiment The data that one of a little scanning means obtain supplement or merge them, are designed to complete the surgery hand to manufacture one kind The device of patient's body is stayed in after art.It will be clearly understood that the data from bone density scan instrument retouch practice herein These inventions stated are not necessary but can be determined with supplementary data and assisted surgery doctor or other healthcare givers Appropriate position, track, orientation or the alignment of these different instruments of this description.
According to the yet other aspects of present disclosure, these data can be mended with the data from bone density scan instrument It fills or merges them, to realize the further control to the orientation of any desirable axis, especially in the surgical operation It is related in the case where being inserted into one or more implantable devices.
According to still another embodiment, the data obtained from the patient allow the instrument to be made with across the instrument Restriction path, these paths and at least one tool, instrument or implantation material it is operatively associated and allow this at least one A tool, instrument or implantation material are inserted into the path of these restrictions in a manner of consistent and is reproducible.It is being implanted or The example for staying in the device of patient's body includes anchor, such as screw, pin, clip, hook etc., and implantable dress It sets, such as spacer, replacement joint, exchange system, bracket etc..
According to the yet other aspects of present disclosure, a kind of surgical template of pre-configuration is disclosed, which includes using In the one or more guiding pieces for receiving at least one tool.According to this embodiment, the one or more guiding piece is further Including be formed substantially with the consistent multiple patient contact surfaces of the anatomical features of patient.The surgical template of the pre-configuration Be configured so that, these patient contact surfaces be configured for by match engagement in a manner of with multiple anatomical features phase Contact, to ensure the correct alignment and installation of the guiding piece or template, and these guidance of the surgical template of the pre-configuration Part is oriented with the direction selected before the surgical template for manufacturing the pre-configuration, so that implementation tool is in the one or more Desired positioning, alignment or propulsion in guiding piece.
According to the yet other aspects of present disclosure, disclose a kind of for creating the side of the template used in surgical operation Method, method includes the following steps:
Collect the data corresponding with the unique anatomical of patient construction from patient；
According to the model of the collected data creation template, which includes the unique anatomical construction for the patient Multiple match surfaces；
Data associated with model are supplied to production machinery；
Quickly generate the template with multiple match surface is included and further comprise in the surgical operation Used at least one tool or at least one corresponding other match surface of instrument；And
The permanent device used in the surgical operation is generated based on the template.
In one embodiment of present disclosure, which is mathematical model.In another embodiment of present disclosure, the mould Type is physical model.
According to the yet other aspects of present disclosure, a kind of system for executing surgical operation to patient is disclosed, this is System includes:
Surgical guidance part；
The surgical guidance part includes the multiple surfaces determined according to the data obtained from the patient scan, multiple surface quilt It is disposed for matching the skeletal anatomy construction of the patient；
The surgical guidance part further comprise it is determining according to the skeletal anatomy of patient construction, for assisting the surgery At least one track or path of operation；
The surgical guidance part further comprises at least one sleeve, which is constructed from a material that be electrically conducting and has first end And second end；
Instrument including at least one first part, the first part be made of an electrically conducting material and be adapted to pass through by At least one first part be inserted into the first end of at least one sleeve and be accepted at least one sleeve and Contact the conductive material of at least one sleeve；
Wherein at least one first part of the instrument is adapted for across at least one sleeve and leaves The second end of at least one sleeve；And
Wherein the surgical guidance part can receive electric current to construct with the surgical guidance part and with patient anatomy It is provided in art during being in contact and monitors (IOM).
The other aspect of present disclosure is related to system as described above, and further comprises surgical guidance part, by At least one electrode is provided on the conductive material of the surgical guidance part and provides electric current at least one electrode, which draws Guiding element receives electric current.
The other aspect of present disclosure provides a kind of in over-the-counter manufacturing site location, making in site place, clinic, operation Center, surgeon office, public hospital or the method in private hospital manufacture surgical guidance part.
Other aspects again of present disclosure include a kind of surgical guidance part manufactured using one of method described herein, wherein The guiding piece is manufactured by technique selected from the group below, which is made of the following terms: rapid prototyping molding machine, stereolithography (SLA) machine, selective laser sintering (SLS) machine, selective thermal sintering (SHM) machine, fusion sediment modeling (FDM) machine, directly gold Belong to laser sintered (DMLS) machine, powder bed printing (PP) machine, digital light processing (DLP) machine, ink-jet photographic resin machine and electronics Beam melting (EBM) machine.
The U.S. patents and patent applications of method and apparatus relevant to surgical operation are related generally to below by quoting It is incorporated herein with entire contents, so that the different aspect for present disclosure provides and written illustrates to support.It is incorporated to by quoting United States Patent (USP) and pending application are as follows: U.S. Patent number 7,957,824,7,844,356 and 7,658,610 and United States Patent (USP) Publication number 2010/0217336,2009/0138020,2009/0087276 and 2008/0114370.
Those skilled in the art is it should be understood that the embodiment of present disclosure can have different sizes.Present disclosure Embodiment these different elements size can based on it is a variety of difference because usually determining, the anatomy structure including such as patient Make, operate or otherwise using the instrument individual or other devices, surgical site position, with it is described herein The physical features (including such as width, length and thickness) for the device and instrument that these devices are used together and the surgery device The size of tool.
Among other advantages, the embodiment of present disclosure proposes the several advantages for surpassing the prior art, including for example The speed and effect of operation, the minimally invasive aspect of operation, the property disposed of these prototype plants, with the smallest risk and to surrounding group Customization instrument or tool are led to the ability of surgical site, lower infection risk, more optimally put by the minimal damage knitted Instrument associated with the surgical operation is placed and is inserted into be further reduced by the guiding piece and implantable device setting and orient The instrument occur it is unjustified or dislocation a possibility that more stable and controlled method and it is less and/or it is cheaper Tool and instrument in surgical site.For example, these embodiments reduce multiple supports used in specific surgical operation Disk, the quantity of instrument and different size of device and the needs to it thus reduce as completion surgical operation and necessary dress Standby cost.The accumulation that these embodiments also reduce both surgeon in surgical environments and healthcare givers and patient is put Penetrate exposure.
Those skilled in the art is it should be understood that the embodiment of present disclosure can be and be configured to be used for by known materials It provides or is predictably manufactured into for providing these different aspects of present disclosure.These materials may include for example Stainless steel, titanium alloy, aluminium alloy, evanohm and other metal or metal alloy.These materials can also include for example PEEK, carbon fiber, ABS plastic, polyurethane, polyethylene, photopolymer, resinae especially wrap up resin material, the rubber of fiber Glue, latex, synthetic rubber, synthetic material, polymer and natural material.
Those skilled in the art is it should be understood that the embodiment of present disclosure can be with use automation or semi-automation The device of manipulation is used in combination.The embodiment of present disclosure is designed such that, can be for example, remotely by operator, remote Journey by operator by computer control, by operator using matching device, sequencing by computer control, by watching Take control mechanism, be hydraulically operated mechanism, by pneumatic actuation mechanism or by piezoelectric actuator come to the instrument carry out at Type and verifying.Purpose for present disclosure is it will be clearly understood that can be in these system and method disclosed herein Using the other kinds of machinery other than rapid prototyping forming machine, such as pass through computerization numerical control (CNC) machinery.
Invention summation part of the invention is neither intended to the whole ranges and model for being also not construed as representing present disclosure It encloses.It is always addressed in invention in appended attached drawing and detailed description of the invention part and elaborates present disclosure with a variety of different the level of detail, And in this summation of the invention includes or do not include that certain component, assembly units etc. are not intended to and limit the range of present disclosure System.From detailed description, when especially understanding together with attached drawing, other aspects of present disclosure will become easier to understand.
Benefit described above, embodiment and/or characterization particularly with for patentable theme disclosed herein not It must be complete or exhausted.By individually or combination is using as set forth above and/or in attached drawing and/or in following explanation Content described in book can be able to achieve other benefits, embodiment and/or the characterization of present disclosure.However, the right being presented below It is required that defining the present invention.
Detailed description of the invention
In conjunction in the description and constitute these part thereof of attached drawings illustrate present disclosure embodiment and with On the general remark that provides and the attached drawing being provided below the principle for being used to illustrate these disclosure contents together is described in detail.
It should be understood that these attached drawings are not necessarily drawn to scale.In some cases, it may have been left out for reason Solution present disclosure is not details that is required or causing other details to be difficult to understand.It should be understood of course that present disclosure need not be by It is limited to specific embodiment shown herein.
In the drawings:
Fig. 1 be according to the perspective view of the threedimensional model of the unique anatomical features group of one embodiment of present disclosure, from These anatomical features can derive one group of data point；
Fig. 2 is to show according to the flow chart of one embodiment of present disclosure and execute a kind of manufacture and use for assisting These different steps of the method for the instrument of surgical operation；
Fig. 3 is the side elevation view according to the particular instrument for assisting surgical operation of one embodiment of present disclosure；
Fig. 4 is the rear elevation view of instrument shown in Fig. 3；
Fig. 5 is relative to unique anatomical features group and the instrument according to one embodiment of present disclosure, Fig. 3 Plan view from above；
Fig. 6 is the perspective view of instrument shown in Fig. 5 and unique anatomical features group；
Fig. 7 is another perspective view of instrument shown in Fig. 3, instantiates patient's match surface of the customization of the instrument；
Fig. 8 is the perspective view according to the instrument of an alternate embodiment of present disclosure；
Fig. 9 is the perspective view according to present disclosure and the instrument of another alternate embodiment；
Figure 10 is that another is thoroughly used in the specific surgical procedure together with the instrument of custom fabricated for instrument shown in Fig. 3 View；
Figure 11 A-B is the perspective view according to the instrument of another alternate embodiment of present disclosure；
Figure 12 is the perspective view of instrument shown in Figure 11 A-B in the assembled state；
Figure 13 is the perspective view according to present disclosure and the instrument of another alternate embodiment；
Figure 14 is the perspective view according to present disclosure and the instrument of another alternate embodiment；
Figure 15 is the perspective view according to present disclosure and another alternate embodiment；
Figure 16 is the different perspective views of instrument shown in Figure 15；
Figure 17 is the decomposition perspective view of instrument shown in Figure 15.
Figure 18-19 is the perspective view according to present disclosure and another alternate embodiment；
Figure 20-21 is the perspective view according to present disclosure and another alternate embodiment；
Figure 22 is the perspective view according to present disclosure and another alternate embodiment；
Figure 23 is the perspective view according to present disclosure and another alternate embodiment；
Figure 24 is the perspective view according to present disclosure and another alternate embodiment；
Figure 25 is the perspective view according to present disclosure and another alternate embodiment；
Figure 26 A is the perspective view according to present disclosure and another alternate embodiment；
Figure 26 B is the perspective view of embodiment shown in 6A according to fig. 2；
Figure 27 A is the forward sight elevation according to present disclosure and another alternate embodiment；
Figure 27 B is the perspective view of embodiment shown in 7A according to fig. 2；
Figure 28 is the elevation according to present disclosure and another alternate embodiment；
Figure 29 A is the perspective view according to present disclosure and another alternate embodiment；
Figure 29 B is the perspective view according to present disclosure and another alternate embodiment；
Figure 30 is the perspective view according to present disclosure and another alternate embodiment；
Figure 31 is the perspective view according to present disclosure and another alternate embodiment；
Figure 32 A is the perspective view according to present disclosure and another alternate embodiment；
Figure 32 B is the perspective view of the embodiment according to Figure 32 A；
Figure 33 A is the perspective view according to present disclosure and another alternate embodiment；
Figure 33 B is the perspective view of the embodiment according to Figure 33 A；
Figure 33 C is the embodiment according to Figure 33 A, describes another perspective view for having the cutting guiding piece of Figure 32 A；
Figure 34 A is the perspective view according to present disclosure and another alternate embodiment；
Figure 34 B is the perspective view according to present disclosure and another alternate embodiment；
Figure 35 is the plan view from above according to present disclosure and another alternate embodiment；
Figure 36 is the detailed view of the device of the embodiment according to Figure 35；
Figure 37 is another plan view from above of the device of the embodiment according to Figure 35；
Figure 38 is the plan view from above according to present disclosure and another alternate embodiment；
Figure 39 is another plan view from above of the device of the embodiment according to Figure 38；
Figure 40 A-D is the other plan view from above of these devices of the embodiment according to Figure 35-39；
Figure 41 includes the side elevation view according to the device of another alternate embodiment of present disclosure；
Figure 42 A-B is the plan view from above according to the device of another alternate embodiment of present disclosure；
Figure 43 A-B is the other plan view from above according to present disclosure and the device of another alternate embodiment；
Figure 44 A-B is the perspective view of device shown in Figure 43 A-B；
Figure 45 includes the side elevation view according to the drill sleeve device of another alternate embodiment of present disclosure；
Figure 46 is the forward sight elevation according to another alternate embodiment of present disclosure；
Figure 47 A-D is the view of the Component tray and arrangement according to another alternate embodiment of present disclosure；
Figure 48 A-C is the view for providing the device of patient-specific contact surface and track in patients with cervical；
Figure 49 A-C is the view for providing another device of patient-specific contact surface and track in patients with cervical Figure；
Figure 50 A-D and 51A-C are again another for providing patient-specific contact surface and track in patients with cervical The view of a device；
Figure 52 A-C is for providing patient-specific contact surface and track another device again in patients with cervical View；
Figure 53 A-E is for providing the unassembled of patient-specific contact surface and track in patients with cervical and assembling Device view；
Figure 54 A-C is the device for providing patient-specific contact surface and track and the instrument for positioning the device The view of device；
Figure 55 A-C is for providing patient-specific contact surface and track another device again in patients with cervical View；
Figure 56 A-D is for providing patient-specific contact surface and track another device again in patients with cervical View；
Figure 57 is the side for the patient-specific insert being used together with device shown in above-mentioned Figure 48 A-56D Depending on elevation；
Figure 58 A-C is filled for creating patient-specific or versatility guiding piece the modeling with predetermined track The view set；
Figure 59 A-D is the view of the still another embodiment of the guiding piece used in patients with cervical；
Figure 60 A-C is the other view of the guiding piece used in patients with cervical；
Figure 61 A-C shows the view of the still another embodiment of the guiding piece used in patients with cervical；
Figure 62 A-E shows the view of the still another embodiment of the guiding piece used in patients with cervical；
Figure 63 A-H show the other embodiment of the guiding piece used in patients with cervical and related equipment it is multiple not Same view；
Figure 64-66 is the view of the device with the customization insert for being inserted into seal wire；
Figure 67 is device shown in Figure 64-66, and wherein insert is removed；
Figure 68 shows Figure 67, and wherein device is removed but these retain；And
Figure 69-73 be according to present disclosure again another alternate embodiment MIS operation used in device it is more A different views；
Figure 74 be further comprise one or more optional alignment/depth/position control components, shown in Figure 69-73 Device perspective view；
Figure 75 is the alternate embodiment of device shown in Figure 69-73；
Figure 76 A-C is the substitution for further comprising one or more optional alignment/depth/position control component devices The view of property embodiment；
Figure 77 A-G is further comprise one or more optional alignment/depth/position control component devices another The view of a alternate embodiment；
Figure 78 A-B is further comprise one or more optional alignment/depth/position control component devices another The view of a alternate embodiment；
Figure 79 A-B is further comprise one or more optional alignment/depth/position control component devices another The view of a alternate embodiment；
Figure 80 is the detailed view of the device of Figure 79 A-B；
Figure 81 A-C is multiple and different views according to the MIS device of another embodiment；
Figure 82 A-B is multiple and different views according to the MIS device of still another embodiment；
Figure 83 A-D is multiple and different views according to the MIS device of still another embodiment；
Figure 84 A-C is multiple and different views according to the MIS device of still another embodiment；
Figure 85 is the view according to another MIS device of alternate embodiment；
Figure 86 A-C is multiple and different views according to the MIS device of still another embodiment；
Figure 87 A-B is multiple and different views according to the MIS device of still another embodiment；
Figure 88 A-B is multiple and different views according to the MIS device of still another embodiment；
Figure 89 A-B is multiple and different views according to the MIS device of still another embodiment；
Figure 90 A-C is multiple and different views according to the MIS device of still another embodiment；
Figure 91 A-D is multiple and different views according to the MIS device of still another embodiment；
Figure 92 A-D is multiple and different views according to the MIS device of still another embodiment；
Figure 93 A-D is the template that the method described herein for being used to create patient-specific device can be used to draw profile Multiple and different views；
Figure 94 A-C is multiple and different views of one embodiment of present disclosure, which includes multiple patient-specific Guiding piece；
Figure 95 A-C is the side elevation view according to the bindiny mechanism of one embodiment of present disclosure；
Figure 96 A-C is the side perspective according to the bindiny mechanism of another embodiment of present disclosure；
Figure 97 A-C is the side perspective according to the bindiny mechanism of the still another embodiment of present disclosure；
Figure 98 A-C is the side perspective of the insert and guiding piece sleeve according to one embodiment of present disclosure；
Figure 99 A-G shows the system for guiding piece to be aligned according to one of these different embodiments described herein Different views；
Figure 100 A-D is the side perspective according to the insert of one embodiment of present disclosure；And
Figure 101 A-D be according to present disclosure again another alternate embodiment patient-specific guiding piece it is multiple not Same view.
Being described in further detail as shown in the drawings and here, present disclosure is related to a kind of existing for developing The novel system and method for patient's matching type instrument of a variety of customizations used in many different surgical operations.The system and Method derives one or more patient's matching types using the patient's the unique form that can be originated from capture MRI data or CT data Instrument, these instruments include relative to that encountered during the one or more surgical operation for being originated from one group of data point The complementary surface on a little surfaces.According to different embodiments described herein, which, which may further include, is wished The axis of prestige and/or insertion track.According to an alternate embodiment described herein, which can be into one It walks and matches at least other instruments used during the surgical operation.Check content disclosed below of the invention And after different embodiments, other features of present disclosure be will be apparent.
Multiple embodiments of present disclosure are depicted in Fig. 1-101.Referring now to Fig. 1, one according to present disclosure is shown The perspective view of the threedimensional model of the unique anatomical features group of a embodiment.Here, model 2 be made of multiple centrums 4,6 but It is that can also be made of any anatomy group of particular patient according to other embodiments.Data associated with model 2 can be from MRI or CT scan or the radiographic image constructed from the correspondence skeletal anatomy of the patient are (or alternatively from other data Source) capture.After capturing the data, known software tool can be used and be converted into CAD program, wherein the data set Representative model 2 and can be used to provide be used to form need the profile of one or more instrument used in surgical operation, The other data point of size, shape and orientation.
According to alternate embodiment, these data can be obtained from ultrasound or nuclear medicine scan device.Again another replace For in property embodiment, supplement can be carried out to the data with the data from bone density scan instrument or merge them, to make It is designed to stay in the device of patient's body after completing the surgical operation, or is alternatively wished to realize to any The further control of the orientation of the axis of prestige is especially related to being inserted into the feelings of one or more implantable devices in the surgical operation Under condition.
Fig. 2 is to show according to different embodiments described herein, execute a kind of device manufactured for assisting surgical operation The flow chart of these different steps of the method for tool.According to a preferred embodiment, method includes the following steps:
A data associated with the anatomical configurations of the patient) are obtained by MRI or CT scan；
B the MRI or CT scan data) are converted into one or more 3-D data sets；
C) determination will be configured for the dress for assisting to need the one or more surgical operation for executing the patient The one or more axis for the orientation set；
D) using identified axis and consider be originated from converted one or more data sets any other about Beam, to this for assisting the device of the one or more surgical operation to model；
E the prototype of modeled device) is generated by using rapid prototyping forming machine；And
F the prototype is prepared) for using during the one or more surgical operation.
As shown in Figure 2, this method may include other step or can be for another used in surgical operation Outer device and repeat.Obtain data the step of typically in a conventional manner, by using MRI or CT or other in ability The scanning equipment being suitble to known to domain makes patient be subjected to scanning to carry out.Then the instrument captures data, and by software or Other algorithmic tools being known in the art can convert this data to one or more 3-D data sets, such as by should Data export in known modeling software routines, which allows to indicate data with such as CAD format.Once should Data are converted, so that it may device is modeled it is complementary with the one or more data set, and with by surgeon it One of preceding or the preliminary sweep by observing the anatomical configurations from the patient the one or more data set determination Or multiple axis are oriented the device.
Consider that this method and step for any other constraint for being originated from converted one or more data sets can wrap Include: the size of the modeled device of adjustment is to adapt to limit surgical space, carry out to the element of the device modeled Orientation is to avoid certain anatomical features, creation can be convenient with one used in the one or more surgical operation or Multiple instruments and/or the associated one or more surfaces of tool operation, etc..Known quick original can be used in the prototype It type forming machine or is generated alternatively by milling machinery such as CNC milling machine.Alternatively, it is made by this method initial Device can further be considered by surgeon and/or be manipulated in transitory state and then using retouching herein The one of these methods stated finally constructs it.These steps can be repeated for complementary device, these complementary dresses Some or all of set may include the device for constructing relative to patient anatomy or previously making other match surface (that is, these manufactured devices can have for making the adjacent match surface together of one or more devices, such as it is following more It describes in detail).
Alternatively, system and method described herein can promote the alignment of the different anatomic feature of particular patient, example Such as the alignment of multiple centrums of patient's body, to correct deformity of spine.For example, the one or more data set can provide It the initial position of these anatomical features but is further handled by surgeon in being arranged in the preoperative with desired by creating One or more data sets, for example, the one or more surgical operation complete when these anatomical features final position.With This mode, these devices formed by system described above and method can be used in the initial position of these anatomical features Or it can match in final position and for each stage of the surgical operation with those specific positions and orientation.This A little stage devices will provide vision guide in turn for surgeon, pass through the surgical operation compared with preoperative plan to determine The correction degree realized.Other variations of the method for present disclosure are described in Summary and are included in institute In attached claims.
Production method may include using rapid prototyping molding machine, such as stereolithography (STL) machine, selective laser sintering (SLS) machine or fusion sediment model (FDM) machine, direct metal laser sintering (DMLS), electron-beam smelting (EBM) machine or other Increasing material manufacturing machine.One example of such rapidform machine is commercially available from 3D Systems company and known models are SLA-250/50.The rapid prototyping molding machine is selectively by liquid, powdered or other unhardened resins or metal Harden into three-dimensional structure, which can be separated with remaining unhardened resin, it be carried out wash/sterilize and It is used directly as the instrument.The prototype molding machine receive these individual digital data sets and generate with it is desired The corresponding structure of each instrument.
May have generally, due to the resin of stereolithography machinery production and non-optimal mechanical property is (for special outer Usually may be unacceptable for section's surgical application), prototype molding machine alternatively can be used and carry out production mould.It is preparing After the mold, conventional pressure or vacuum molding machine can be used and produce the instrument by the material being more suitable for, as stainless steel, Titanium alloy, aluminium alloy, evanohm, PEEK, carbon fiber or other metal or metal alloy.
According to another alternate embodiment, which may include being supplied to the one or more data set CNC machine, the machine so that can with come by the material of satisfactory mechanical property listed above manufacture it is a kind of customize milling device Tool.In another alternate embodiment again, such as specific the case where being orientated or being inserted into track is shared between jumpbogroup patient Under, a large amount of manufactures of the instrument according to embodiment described here also may be implemented.
According to present disclosure specific embodiment, provide a kind of relevant to the backbone of patient a variety of for being produced on The system and method for instrument used in surgical operation.It is prominent with degenerative disc disease, natural deformation of spinal column, interverbebral disc Out, the individual of spinal injury or other spinal diseases generally require affected part carry out surgical operation with alleviate individual pain and The further damage of prevention.Such spinal surgery may relate to the removal of impaired joint tissue, anatomic implants insert Enter and/or the fixation of two or more adjacent vertebrals, wherein the surgical operation depends on the property and degree of damage and changes.
For the trouble with different degrees of degenerative disc disease associated with back pain and/or neurothlipsis Person treats this degenerative disease usually using spinal fusion surgery or lumbar spinal fusion (" fusion ").Fusion is usually directed to One or more intervertenral spaces are strutted and/or depressurized, any associated zygapophysial joint or articular disc is then removed, then will The combination of two or more adjacent vertebraes or " fusion " are together.The fusion of centrum also generally relates to two or more adjacent vertebras The fixation of bone, this can be completed by the way that bar or plate and screw or other devices to be introduced into ridge joint, so as to by vertebra Different piece is connected in the corresponding portion on adjacent vertebrae.
Fusion can carry out in the lumbar vertebrae, thoracic vertebrae or cervical region of patient.Fusion needs to be used for enter vertebra and will The tool of the implantation such as desired implantation material, any bioactive materials.Such operation generally require to introduce other tool and/ Or instrument, including bore, bore guiding piece, debridement tool, flusher, vice, fixture, intubation, retractor, Distraction Apparatus, cutter, cut Cut guiding piece and other insertion/drafting tools and instrument.The insertion, alignment and placement of these tools, instrument and fixed device Success for surgical procedure is critical.Similarly, provide customization and patient-specific tool or instrument increase A possibility that surgical operation success.
For example, depict in figures 3 and 4 by system described above and method formation and can be used for it is specific The related surgical operation of fixation a kind of particular instrument.According to one embodiment of present disclosure, which can be in pedicle of vertebral arch The form of screw guide 10, the pedicle screw guiding piece include intermediate body member 12 and two generally elongated wings 14, Each wing 14 terminates in generally cylindrical column 16.In a preferred embodiment, as described in Fig. 3, these circles Each of cylindrical column 16 is all substantially hollow to allow the device of one or more types to be inserted through wherein. Intermediate body member 12 further comprises longitudinal cavity 20 for being formed about in the lower surface of intermediate body member 12 (as obtained in Fig. 3 Shown in perspective view).As described in more detail below, these cylindrical each of columns 16 further comprise lower part patient Contact surface 18,19, lower part patient contact surfaces and longitudinal cavity 20 together provide for multiple anatomical features phases Matched multiple patient-specific profiles.
The profile and position of these lower parts patient contact surfaces 18,19 and longitudinal cavity 20 are by using from patient What one or more data sets that MRI or CT scan convert were formed.Pedicle screw guiding piece 10 shown in Fig. 3 and 4 Rest part can be formed to meet surgical special preferences.For example, these wings 14 only need long enough and by this Two cylindrical columns 16 are located in the position of corresponding patient's matching type anatomical features.In the novelty without departing from present disclosure In the case where aspect, these wings can be using other shapes, orientation, thickness etc..Similarly, intermediate body member 12 only need by Other extensions for accommodating longitudinal cavity 20 and may include other than these wings 14 are sized to, to help such as Catch or manipulate as desired pedicle screw guiding piece 10.
In addition, these wings 14 can be malleable or semi-rigid material is made by half, to work as 10 quilt of pedicle screw guiding piece At least generating unit point is interference fitted when being placed in the corresponding anatomy group for specific surgical procedure.For example, working as the two Cylindrical column 16 and inferior articular process can form buckle or interference when being adjacent to placement by the subtle deflection of these wings 14 Cooperation, once and then these wings are positioned with their final orientation, just deflect to desired position.More fully below Ground describes the another aspect of present disclosure in this regard.
Fig. 5 is relative to unique anatomical features group, the instrument according to one embodiment of present disclosure, Fig. 3 Plan view.Herein, pedicle screw guiding piece 10 is positioned such that intermediate body member 12 is centrally located on the central part of centrum 4 Top, so that the profile of longitudinal cavity 20 and the spinous process 41 of this specific centrum 4 matches.Equally, these cylindrical columns 16 are oriented at each medial side of pedicle screw guiding piece 10 one, so that vertebra of these wings 14 across centrum 4 Plate 43 and these cylindrical columns 16 are located near inferior articular process 44,45.The lower part patient contact surfaces of cylindrical column 16 18,19 are formed to match with the profile of inferior articular process 44,45 and at the rear of processus articular superior 42.
Therefore, pedicle screw guiding piece 10 provides multiple pairings or matching position, any one position of these positions It all will affect taking a seat for other two position if setting and not being correctly positioned.The pedicle screw guiding piece mentions in this respect The significant improvement for surpassing the prior art is supplied, the prior art may slightly rotate, unjustified or misplace and cure in surgery Raw apparently device still seems correctly to take a seat.The redundancy and plurality of mating face ensures that pedicle screw guides Part 10 was not only correctly positioned but also was properly aligned.If pedicle screw guiding piece 10 is not correctly positioned or right Together, then lower part patient contact surfaces 18,19 will not be able to cooperate on each inferior articular process 44,45 and thus prevent longitudinal cavity 20 are firmly sitting on the spinous process 41.
Fig. 6 is the perspective view of instrument shown in Fig. 5.Desired insertion trajectory line A, B is shown to illustrate: in addition to every Also to these, cylindrical column 16 is positioned except the orientation of these axis of the column 16 of a cylinder, this can be relative to They and inferior articular process 44,45 it is adjacent take a seat and it is independent (that is, the axis is relative to method between these cylindrical columns 16 The direction of line can be different).The orientation of these cylindrical columns 16 is also to derive from the one or more number described above According to collection and the selected of the orientation is to be based in a preferred embodiment, which will allow for fix device (that is, vertebral arch Root screw) it is consistent with the vertebral arch location of root ground and avoiding the fixation device from being inserted upwardly into from the side that the pedicle of vertebral arch penetrates It (extends through the pedicle of vertebral arch that is, eliminating the screw or causes the pedicle screw to exit from the side of the pedicle of vertebral arch with one Angle a possibility that being inserted into).
These customizations of instrument shown in Fig. 3-6 or configuration patient contact surfaces pass through the pedicle of vertebral arch screw in Fig. 7 The face upwarding view of guiding piece 10 is followed closely to be illustrated.Here, these lower parts patient contact surfaces 18,19 may include with more The dynamic outline of a compound radius, so that these surfaces 18,19 and the corresponding anatomical features of these vertebras are completely the same.Cause This, these surfaces will substantially be located in the surface of this these vertebras with column 16 cylindrical in surgical procedures It is consistent, and will not be substantially consistent from a different surface of these vertebras.By this method, if pedicle screw guide part 10 misalignments, surgeon can be apprised of immediately, this is because it will be not properly fixed on these vertebras.
Fig. 8 shows the instrument of an alternate embodiment according to present disclosure.In this embodiment, it shows opposite In the multi-segmental pedicle screw guiding piece 10' of the centrum 4,6,8 of several adjoinings.Multi-segmental pedicle screw guide part 10' packet Multiple second level wing 14' and the three-level wing 14 " are included, each of which has corresponding for being inserted into multiple pedicle screws And it is registered to the cylindrical column 16' in adjacent vertebra section 6,8,16 ".It should be clearly understood that may be implemented in number Upper multiple segments more than or less than three, without departing from spirit of the invention.
Fig. 9 shows the instrument of another alternate embodiment again according to present disclosure, which includes multiple sections 12",12'",12"".Similar to embodiment shown in fig. 8, this pedicle screw guiding piece 10 " allows pedicle screw pair In quasi- and insertion backbone multiple segments 4,6,8.", 12' ", 12 " ", respectively have in modified however, multiple section 12 Between ontology, which includes abutting end and receiving end, and ", 12' ", 12 " " can be as in Fig. 9 so that multiple section 12 It is shown to be connected.The receiving end of each of multiple section 12 ", 12' ", 12 " " section and abutting end are different, so that It can only realize that these sections 12 ", 12' ", 12 " " are correctly ordered (that is, section 12 " can only be with section 12' " is even in assembling Knot).The yet other aspects of present disclosure are instantiated in this figure, especially make specific device pairing or connection adjacent to each other Ability, to further ensure that being aligned and match and providing to vertebra for particular anatomical features associated with each device Bone applies the means of corrective force and visualizes malformation correction degree.
Figure 10 shows the instrument of the embodiment according to Fig. 5 of the instrument with customization, and the instrument of the customization is specific outer Section can be used cooperatively during performing the operation with the instrument.For example, in spinal fusion (such as described above that), Commonly one or more pedicle screws are attached on the vertebra of patient to realize in desired centrum by surgeon Fusion.Cylindrical column 16 can have interior diameter corresponding with the overall diameter of instrument 60 being gradually increased, so that instrument 60 It can only be advanced in cylindrical column 16 to predetermined distance, thus rigid backstop action is provided and provide in turn For preventing pedicle screw 62 to be advanced to means too far in patient bone anatomical configurations.According to still another embodiment, The hollow space of cylindrical column 16 can have the section (being not shown in Figure 10) of an interior diameter with constriction, the section Correspond to the end stop member cooperated with the overall diameter of instrument 60 with position in one way, to prevent the instrument from excessively penetrating In cylindrical column 16 and thus pedicle screw 62 is inserted into more than safety margins.
Figure 11 is the perspective view according to present disclosure and the instrument of another alternate embodiment.Here, the instrument is vertebra Pedicle screw guiding piece 100, it further comprises the narrow bridge 112 around the intermediate body member, which allows lantern ring 130 and warp The pedicle screw guiding piece 100 of modification is connected, as shown in Figure 12.Lantern ring 130 may include the spinous process phase with patient The lower surface (similar to longitudinal cavity of embodiment shown in Fig. 3) for the belt profile matched and pedicle screw can be inserted into To match with the specific anatomical features of the vertebra to undergo surgery during surgical operation in guiding piece 100.Therefore, In this embodiment, other than the lower part patient contact surfaces 118,119 of the two cylindrical columns 116, lantern ring 130 is also At least one of profile matching profile is matched including these patients and can be removed and according to outer on different vertebras Section's operation needs to be replaced with other differently contoured lantern rings.In this embodiment, these cylindrical columns 116 can be into One step includes one or more apertures 111, so as to when pedicle screw is being advanced in these cylindrical columns 116 Conducive to so that the pedicle screw visualizes.
Figure 13 is the perspective according to present disclosure and the instrument for assisting surgical operation of another alternate embodiment Figure.It in this embodiment, include laminectomy cutting guidance by the instrument that system described above and method are formed Part 150.This laminectomy cutting guiding piece further comprise for be inserted into seal wire or other tightening members at least one Alignment channel 151 and the cutting line of rabbet joint 152 for guiding the path of blade or other cutting edges.As retouched in Fig. 3 above The pedicle screw guiding piece stated, it also includes lower part patient contact surfaces 155 that this laminectomy, which cuts guiding piece 150, should Lower part patient contact surfaces allow laminectomy cutting guiding piece 150 and one or more centrums to match.Although in Figure 13 Be illustrated as the prism of overall rectangular, but it should be expressly understood that, for laminectomy cutting guiding piece 150 other Geometry is same practical and should be considered within the scope of present disclosure.
Figure 14 shows another alternate embodiment again of present disclosure.In this embodiment, by described above The instrument that system and method are formed includes pipe retractor 160, which also includes lower part patient contact surfaces 165. This patient contact surfaces 165 is with being formed in the property of can choose of the pipe retractor from the cylindrical sheet of pipe retractor 165 In the section 164 removed on body 163, so that section 164 is re-formed and is connected to cylinder when for each patient When on shape ontology 163, the pipe retractor 165 can be reused in many operations.The pipe retractor further include for The generally hollow inner cavity 162 and at least one contact pin 161, assisted surgery doctor manipulated in insertion process ensures that pipe is led Open the correct alignment of device 160.
Figure 15-17 instantiates another alternate embodiment again of present disclosure.In this embodiment, which can wrap Patient's matching type guiding piece 180 is included, with for assisting the placement of one or more interbodies, such as example but not It is limited to: for introducing the implantable stent or artificial intervertebral disk of one or more bioactive substances or bone graft.In Figure 15 In 16, patient's matching type guiding piece 180 is with a possible position relative to unique anatomy group (in two adjacent vertebras Between bone) to show one or more interbodies are placed with assisted surgery doctor.
Patient's matching type guiding piece 180 is shown with decomposition view in Figure 17, uses system described above to show How system and method can manufacture multiple components for specific surgical procedure.These components include patient-specific insertion piece 182, guiding piece sleeve 184 and multiple connectors 186, they form patient shown in Figure 15 under final assembled state Distribution type guiding piece 180.
Referring now in detail to Figure 18-19, another alternate embodiment of present disclosure is shown.According to this embodiment, retouch Surgical template 190 is drawn, which can be further combined with having multiple fixed devices 198,198', these fix device can For fastening the template 190 in a number of different manners.According to this embodiment, template 190 includes being oriented to across trouble It the centre portion 192 of person's spinous process and may further include for being inserted into the more of one or more fixed devices 198,198' A aperture (being not shown in Figure 18-19).Template 190 may further include the part that two extend laterally or " wing " 194, this A little parts or the wing are respectively with the termination of guiding piece 196.To saying for the guiding piece provided above in conjunction with other embodiments disclosed herein It is bright to be incorporated to hereby about this embodiment by quoting.
Multiple fixed devices 198,198 ' can be passed through the centre of template 190 by the embodiment according to shown in Figure 18-19 Multiple aperture (not shown) in section 192 are inserted into stablize template 190 and be fastened on patient's spinous process.According to one Embodiment, the direction of the first fixed device 198 and orientation are different from orientation and the direction of the second fixed device 198', so as into one Step improves the stability of the template 190 before improving these permanent fixtures.According to still another embodiment, this some holes It mouthful can be located at and to be different from discribed position and can be according to surgeon and patient-specific bone in Figure 18-19 The demand of anatomical configurations and quantity is smaller or larger.
Referring now in detail to Figure 20-21, another alternate embodiment again of present disclosure is shown.In this embodiment In, template 200 further comprises two other contact surfaces 205, these contact surfaces preferably have at patient contact end It the hollow open at place and extends through wherein for insertion into the aperture of fixed device 199,199'.As combined Figure 18-above Described in 19, these fix device 199, the purpose of 199' is in order to which template 200 is fastened to skeletal anatomy structurally simultaneously And it assists to fasten multiple permanent fixture (not shown) by multiple guiding pieces 206.
Referring to fig. 20, template 200 includes extending from the top surface of template 200 for be inserted into the first fixation device 199 Protrusion 208, protrusions 208 are the hollow shapes and length to adapt to the fixation device 199 in part.Protrusion 208 is in mould The part extended laterally or " wing " 204 top of plate 200 extend, as shown in figure 20.Protrusion 208 can extend above template It is more more or less than shown in Figure 20, in order to provide the rigid backstop action of the insertion to fixed device 199.Similarly, template 200 The opposite part extended laterally or " wing " also include raised 208' for be inserted into the second fixation device 199'.
In conjunction with above with respect to patient contact surfaces and the disclosure content that models to it is determined, according to this embodiment template 200 have at least four patient-specific contact surfaces 205,207.This embodiment improves the stability of template and positioning, And surgeon is allowed to realize the surgical template of dynamic stability, this ensures all permanent fixtures for spy in turn Determine the predetermined direction of surgical needs and orientation is positioned and is inserted into.This is by providing this four patient contact surfaces It realizes, these patient contact surfaces are worked just as the leg of desk and determined about subjects bones' anatomical configurations Position further improves the stability and positioning of template 200 in different location (and on a different plane).
It is special that the embodiment according to shown in Figure 18-21, these guiding pieces and other patient contact surfaces can be depth Property and can be adapted to provisional fixed device insertion subjects bones' anatomy structure further combined with there is certain inner diameter To controlled depth in making.In addition, these guiding pieces can have specific thread inner surface to adapt to specifically fix device And it is convenient for the insertion of screw fixing device such as screw.In certain embodiments, these templates can for particular patient come It designs to prevent these from fixing devices and excessively to penetrate in skeletal anatomy construction or fixed convenient for first group of controlled depth Device temporarily fastens these templates.
According to still another embodiment, each of these patient contact surfaces surface may have band contact patient Cutting surfaces integrated blade, the blade be around the patient contact surfaces at least part it is integrated so as to solid at these Determine taking a step forward for the insertion of device to set the template and be fastened to skeletal anatomy structurally.The purpose of the blade is to cut Soft tissue is worn to realize better template and the bone-contact between template and subjects bones' anatomical configurations.These guiding pieces Other of hollow space and template patient contact surfaces further allow for soft tissue and have been set at desired position in template Become to be located in these cavity surfaces after setting, thus further will be on dies plate tap to subjects bones' anatomical configurations.The knife Piece can be it is substantially cylindrical or it is circular with match the shape of guiding piece or can be oval, polygon or other Shape is to match patient contact surfaces.
In order to further to patient contact surfaces described herein to patient anatomy structurally take a seat and place increase Stability, these contact surfaces may further include one or more spines or tooth, these spines or tooth are for contacting and extremely Penetrate patient anatomy's construction partially to fasten the device to position.In one embodiment, these spines or tooth can To be manufactured from the same material and can be permanently attached on patient contact surfaces.In another embodiment, these points Thorn or tooth can by different materials, for example those of be described herein and be made, and can be further as needed by selectively It is inserted on one or more surfaces in these patient contact surfaces.
Referring now to Figure 22, another alternate embodiment again of present disclosure is shown.According to this embodiment, template 220 have multiple patient contact surfaces 212,219, these patient contact surfaces are by using " floating " patient's matching type portion What part 214 was realized, which can be inserted before or after first group of patient contact surfaces 212 are positioned Enter in one of multiple guiding pieces 216.Patient's matching type component 214 may further include longitudinal key 218, the longitudinal key and guidance The line of rabbet joint or groove (being not shown in Figure 22) in part 216 it is corresponding with convenient patient's matching type component 214 relative to template 220 appropriate positioning (rotatably).
Therefore, according to this embodiment, template 220 can be fastened to position desired by it by using by template 220 At least two fixed device (not shown) and be fastened in first position, and then can be by multiple patient's matching types portion Part 214 is inserted into these guiding pieces 216 of template 220 and enters around two different locations of subjects bones' anatomical configurations Seat.
Referring now to Figure 23, the still another embodiment according to present disclosure is shown, wherein instrument 240 can be used to assist Help insertion according to the template 230 of different embodiments disclosed herein.The instrument 240 is preferably by 244 structure of handle 242 and adjutage At the length of, the adjutage can depend on particular patient anatomical features and/or surgeon's preference and change.Extending The far-end of arm 244 is contact pin 246, which is formed the correspondence line of rabbet joint that matching is located on a surface of template 230 236.In operation, instrument 240 can be connected with template 230 and for template 230 to be inserted and positioned on the outer of patient In section's operative site.
Referring now to Figure 24, another alternate embodiment of present disclosure is shown.According to this embodiment, can provide With lower template 250, the template be not patient-specific (but can be in an alternative embodiment patient-specific) and Further provide the means multiple patient-specific components 254 being attached in template 250.As shown in figure 24, can pass through By aperture 252,258 be aligned and be attached one or more clamp devices (being not shown in Figure 24) such as screw, pin or its His similar device, these components 254 are fastened in template 250.Once these components 254 are secured in template 250, this A little patient contact surfaces 262 may be used for guiding the template 250 of the component 254 with integration and be located at institute In desired position.In this way, it is possible to provide standard form 250 before obtaining any patient data and by the standard Template is combined with the patient-specific component 254 formed after having captured patient anatomy's data, is thus eliminated The customization of the template is machined or is made for specific surgical procedure application.
According to this embodiment, template 250 can be can reusing or can be in an alternative embodiment primary Property.Template 250 can be made of any material listed here but is closed by metal, metal in a preferred embodiment Gold or the material based on polymer are formed.According to another alternate embodiment again, these components 254 can buckle in place or tool There is frictional fit to connect and does not need screw or other clamp devices therefore to be attached in template 250.In another substitution Property embodiment in, template 250 can be sized and be orientated offer with various, so as to cover patient anatomy construction Variation and different size of centrum (for the different segment of patient spine or region).
Referring now in detail to Figure 25, another embodiment of present disclosure is shown.In this embodiment, template 270 has There are multiple patient contact surfaces 276,278 and further comprises for template 270 to be fastened to the supraspinous multiple folders of patient Tool 272.According to this embodiment, these fixtures 272 respectively there are patient contact surfaces 274 (be designed to herein each Kissing spines around lateral side) so as on the desired position that constructs dies plate tap to patient anatomy.In these fixtures 272 Each can laterally be positioned relative to template 270 (being shown in elevation) and ontology relative to template 270 is attached It is connected to setting position.These fixtures 272 can be fastened to fixed position against spinous process by a variety of any means knowns, these Means include bolt mouth structure, ratchet mechanism, direction specificity blocking mechanism or the releasable tightening mechanism of selectivity.At this In embodiment, these fixtures 272 allow the opposing force occurred in skeletal anatomy construction to carry out relative to the template 270 of patient Balance.In turn, which ensures and template 270 is maintained to thereby further ensure that pass relative to the alignment of bone surface Accuracy for the insertion of permanent fixture.These fixtures can take various shapes or embodiment, including pin, The apparent surface of the opposed stability force of the application of blade or any other type.
According to one embodiment, the surgical guidance part described in Figure 24 and 25 may include the trouble in these guiding piece sleeves Surface (referring to 254, Figure 24) around person's contact jaw herein should so as to soft tissue existing for complying at articular process complex The vertebra of the patient contact end in contact patient of guiding piece sleeve (referring to 278, Figure 25).Therefore, according to this embodiment, this Or multiple generally cylindrical guiding piece sleeves include being rendered as half of cylindrical body or part cylindrical (such as institute in Figure 24 and 25 Show) patient contact surfaces contacted to avoid with this soft tissue.
In an alternative embodiment, which, which may further include, has been cut open or can select The one or more parts for being cut open or disconnecting to selecting property are placed with benefit.It is outer as showing one in Figure 26 A and 26B Section's guiding piece.According to this embodiment, which includes multiple patient contact surfaces, one or more of patients Contact surface has been modified into the gap (surface in 6A referring to fig. 2 be conducive to when the guiding piece is being placed in position 282).In addition, surgical guidance part described herein may include one or more for the guiding piece to be fastened on optimum position In clamping element, such as the fixture 284 described in Figure 26 A and 26B.
According to still another embodiment, the one or more guiding piece sleeve 254 can further allow for insertion one or Multiple inserts and guiding piece sleeve 288, as shown in figs. 27 a and 27b.These inserts 288 can be sized to so that The interior diameter of overall diameter and the one or more guiding piece sleeve 254, which matches and has, extends longitudinally through insert 288 To accommodate the inner openings of different size of apex point or screw tap (for example).In practice, insert 288 can promote and Guidance apex point creates pilot hole to be further inserted into fixed device, such as screw.According to one embodiment, insert 288 can To further comprise identifying one or more labels of specific insert 288 for the specific segment for patient spine or referring to The direction of the bright insert 288, orientation, purposes or purpose other labels.
Referring now to Figure 28, equipped with these inserts 288 of the surgical guidance part for being matched with guiding piece sleeve 254 It can have different length L and the geometry of these guiding pieces, patient anatomy's construction, insert can be depended on Purpose etc. and be made into longer or shorter.For example, if requiring the specific bit of longer depth, insert 288 can be compared with It is short to be further penetrated through in patient's vertebra with adapting to apex point.Equally, the internal holes of insert 288 can depend on being intended to and the insertion Particular tool or instrument that object is used together and there is different-diameter (as drawn in Figure 29 A and 29B).By this method, surgery is cured It is raw to may insure when executing surgical operation he or she to pass through each of these inserts that (insert be into one Step includes the commitment positions for being used to indicate the insert or one or more labels of special-purpose) correct tool is used, Such as drill bit or screw tap.The further explaination of these principles is described above by reference to Figure 29 A and 29B, is accordingly retouched in these figures Insert with 4.5 millimeter apertures for placing screw tap instrument is drawn and for being used together with 1/8 inch drill bit The insert of 1/8 inch aperture.
Referring now to Figure 30, according to one embodiment, these inserts 288 described above can also include that patient is special Property contact surface 294, with for other than guiding piece sleeve 254 further such that the insert 288 and patient-specific solution Construction is cutd open to match.This allows the bigger stability of insert 288 and positions and allow to include drawing for insert 288 Guiding element is in correct position.In addition, for the insert 288 being used in combination with drill bit or other vibrations or oscillation tool, insertion These patient's match surfaces 294 on object 288 will also prevent the distal end of the drill bit when creating initial pilot hole in the table of centrum On face " walking " or mobile, the true risk of the skew of fixed device is thus reduced.
According to the other embodiment of present disclosure, by more detailed from (and according to several embodiments described herein) above These patient contact surfaces that one or more protruding portions that the main body of the surgical guidance part of description extends are formed may include point Sharp or half sharp engagement edge, with soft around patient anatomy's (for example, zygapophysial joint) for penetrating and being attached to Tissue.According to this embodiment, these contact surfaces may include the recessed cavity for soft tissue intrusion.These are recessed Cavity have around the edge of branch leg outer side, these edges can be sharp or selectively be sharpened in order to cut through soft group Knit to place on the bone of lower section/it is paired.This must be positioned at small error journey for the accurate location of patient contact surfaces It is even more important within degree and for the spinal surgery that must persistently be kept in entire surgical procedure.
Referring now in detail to Figure 31, which may further include the generally cylindrical body in the insert Key or recess 296 around one surface, the key or recess are configured for cutting on the guiding piece sleeve 254 with the device Mouth or the line of rabbet joint 298 match.By this method, when guiding insert 288 to enter in the hollow body of guiding piece sleeve 254, it is ensured that Appropriate rotation/orientation of the insert.
Referring now to Figure 32 A-34B, provide to cutting guiding piece (such as describe in Figure 13 above this) It is further described.According to one embodiment, which includes around the multiple of at least one surface of the cutting guiding piece Patient-specific contact surface 302.The cutting guiding piece further comprises patient-specific " track " in a preferred embodiment 303, it is connect with the insertion (as shown in Figure 33 A-C) for promoting cutting instruments and by further providing for one or more instruments Surface 304 is touched to control the insertion depth of the instrument, to prevent surface during specific surgical operation to lower section Unnecessary cutting.According to embodiment shown in Figure 32 A-34B is combined, which can be provided for vertebrae plate resection Art.According to other embodiments, which can be manufactured into complete for executing centrum time among other things Resection, pedicle osteotomy (PSO), Smith-Peterson osteotomy (SPO), Total spondylectomy art (VCR) or not right Claim osteotomy (in sagittal plane or coronal-plane).
These patient-specific cutting guiding pieces are according to patient anatomy's data making and can assist executing The operation of complexity, the certainty of its result are more preferable.For example, certain osteotomies such as PSO and SPO require very high surgical operation Technical ability and usually time-consuming.This is partly due to the close relation of blood vessel element and neural element and skeletal structure, this is right It securely and effectively cuts bone the challenge in terms of proposing guiding during one of these operations in surgeon.This for Posterior approach is especially true.By using the special guiding piece of patient, surgeon confirmation can cut rail before starting operation The positioning and alignment of mark and path, and can be in the further content of the present disclosure provided above with respect to Figure 32 A-34B There is provided for avoid with blood vessel element and the nerve contact of element and it is essential a degree of deep-controlled.
In one embodiment, cutting tool associated with cutting guiding piece shown in Figure 32 A-34B is typically The tool types just used at present in current surgical operation.According to another embodiment, which may include dedicated cutting Prickle or tip are to promote the position to the instrument and the further control of depth, as described in more detail below.For example, such as Shown in Figure 33 A-33C, the cut portion of the instrument can have tracking ball 308, which prevents the instrument to be inserted into the cutting It is more than required by the patient-specific operation in guiding piece.
As shown in more detail Figure 34 A-34B, tracking ball 308 can be inserted into " track " 303 of the cutting guiding piece In first part but be not allowed insertion cutting guiding piece " track " second or deeper portion in (allow the cutting surfaces Advance through this second or deeper portion), thus ensure the appropriate depth of the cutting instruments.It can provide in addition to Figure 34 A- Other geometric configuration except shown in 34B, these configurations allow top surface of the tracking ball 308 relative to the cutting guiding piece It moves horizontally and in the track 303 of the cutting guiding piece that laterally moves and be moved downwardly into some cases. In this embodiment, therefore the cutting instruments can be allowed in the track of the cutting guiding piece around patient anatomy constructs Some depth is moved in 303 some position but real at the other positions around " track " 303 of the cutting guiding piece Now bigger depth.Therefore, that is allowed can be in the cutting guiding piece relative to the depth of the cutting guiding piece about the instrument " track " 303 around be variable.
By using these patient-specific other benefits for being realized of cutting guiding pieces include: provide realization quickly and Controlled resected bone means；Provide the spatial orientation of the cutting tool used during the operation；By to instrument Controlled guidance and both visualizations in planning process in the preoperative, it is ensured that notch is properly oriented within；It provides before being cut Accurate calculating to malformation correction；Accurate resected bone is provided, this ensures malformation correction in turn；The cutting of controlled depth Limitation, to protect neural element and blood vessel element；Controlled cutting vector, and avoid contact or injury to neural element； And the energy of notch approach is provided in posterior approach, anterior approach, posterolateral approach, transforaminal approach or Direct Lateral Approach Power.
Figure 35 is the plan view from above according to present disclosure and another alternate embodiment.In this embodiment, it fills One or more patient contact elements including break-off portion 314 can be provided by setting 310, these patient contact elements allow not make The device and subjects bones' anatomical configurations are positioned separately fixed device (such as pedicle screw).The side edge that fractures can be with It is formed by creating the line of rabbet joint 315 in the surface of the surgical guidance part part of the device, these lines of rabbet joint, which provide, makes these portions Divide the 314 perforation axis to fracture.
According to this embodiment, which can be asymmetric, this two different interior diameter of permission: one Convenient for guidance handheld tool (that is, drill bit, screw tap) and another protrusion for accommodating the device or cap are (for example, pedicle screw Nose (tulip)).Once the break-off portion 314 of the guiding piece sleeve is removed, it is possible to have to vertebra Clear Line Of Sigh and Path, and allow to place pedicle screw with not removing the guide device.
Figure 36 is the detailed view of the device of the embodiment according to Figure 35.These lines of rabbet joint 315 are shown in FIG. 36 Detailed view, these lines of rabbet joint can form in 310 manufacturing process in a preferred embodiment but can in alternate examples With after having made the device by perforation or other be used for around some surface of the guiding piece sleeve of device 310 The technology of the line of rabbet joint 315 is created to be formed.
Figure 37-39 is the additional views of the embodiment according to Figure 35 and the device about figure description.In Figure 37 In, show the asymmetric guiding piece sleeve that the two break-off portions 314 have been separated with the device 310.It is shown in FIG. 38 Shown in Figure 26 A-B and about its described embodiment, but the embodiment have now it is described above with folding The asymmetric guiding piece sleeve of disconnected part 314.
Figure 40 A-D be according to have at least one or more break-off portion embodiment, above for Figure 35-39 describe Device additional perspective view.Once being removed, these break-off portions are preferably abandoned by surgeon.
Each of these embodiments described herein embodiment can provide into modularization (that is, single segmental) or whole Body formula (that is, multi-segmental) configuration.Therefore, it is conducive to illustrate provided herein for convenience, some embodiments are in (a module Change or monoblock type) show in embodiment, but also may be provided in different (monoblock type or modularization) configurations, without departing from originally draping over one's shoulders The spirit of dew.At multiple and different aspects, these monoblock type embodiments may include for centrum from two to ten section From anywhere in section or cover multiple positions in addition to backbone of subjects bones' anatomical configurations.It is expressly understood that, These embodiments of this description are the purpose for displaying present disclosure some embodiments and the model for being not intended to be limited to present disclosure It encloses.
According to these different embodiments described herein, can rapidly and easily make for surgery or teaching type Various fixed device, including but not limited to pin, screw, hook, fixture, bar, plate, spacer, wedge used in setting Son, implantation material etc..Similarly, various instruments and/or other devices can be made based on patient-specific data, including But it is not limited to patient's matching type inserter, scraper, cutter, elevator, curet, rongeur, probe, screwdriver, blade, ratchet machine Structure, removal and salvage tool, intubation, surgical mesh etc..
Include in instrument can be made using patient-specific data and including multiple patient's matching types surface It is used as the device of implantation material, including numerous for restoring the implantation material of the disc height in patient's vertebra.For example, using The method of this description can make metal, polymer or the elastic implant of various patient's matching type, the wherein implantation Certain patient contact surfaces of object accurately and precisely match the anatomical configurations of patient.In one embodiment, the implantation material Can with the regression of patient and the anatomical features that need to restore match.In another embodiment, the implantation material Can be correction patient anatomy construction present in structural or physiology it is lopsided necessary to and be consequently for correction suffer from The position of person's anatomical configurations or alignment.Other implantation materials can be patient-specific but be not used to recovery or other knots Structure sexual function (that is, hearing aid implantation shell).
Implantation material described herein can be manufactured by increasing material manufacturing.Under the background of spinal implant, these implantation Object can all approach (preceding, direct lateral, intervertebral spinal fusion, rear, rear outside, directly after outside etc.) in use.The plant The special characteristic for entering object can solve certain surgery purposes, such as restores lordosis, restore disc height, restore sagittal plane Balance or coronal face balance etc..
The other application that present disclosure is imagined includes intercentrum fusion implant, disc height recovery implantation material and end plate Or other vertebra defects have footprint area matching, largest surface area, shape and outline implantation material, and can be into One step specifies contact area, such as relative coarseness degree or other surfaces feature.For example, can be made based on patient anatomy's construction Work further comprises the implantation material of direction specificity shape, and the implantation material is allowed to fit through inlet port without difficulty simultaneously Into in intervertenral space.Alternatively, which can be to consider at implantation point and across the path that the implantation material must pass through The mode of anatomical constraint factor make, and can be further compensate for anatomic defect.In the background of spinal implant Under, these implantation materials can further specify that the desired angle of lordosis or the calibration of coronal planar defect, specify the implantation material Patient-specific height or (disc height restore after desired height), specified allowed opening degree (for can For opening implantation material) and surgical operation and surgical preference can be depended on but unidirectional or multidirectional.
According to one embodiment, patient's matching type vertebral plate can be created with production patient's matching type device.For example But it is not limited, patient data can be obtained to create one or more cervical vertebras or waist for column reconstruction surgical operation The match surface of vertebra anterior plate.Plate may include the profile or surface characteristics for matching skeletal anatomy construction, including across being more than The match surface of one segment or vertebra.In another embodiment, which, which can be used for creating, has Board position The particular patient of identifier matches template and may further include patient-specific customization drilling or other snap points. In addition to utilizing in spinal surgery and described other than those, other kinds of plate can also be combined with herein Patient's matching characteristic of description, without departing from present disclosure.
Referring now to Figure 41-44, the alternate embodiment of present disclosure is shown.In certain operations, in specific surgery hand Among art position or nearby need multiple tracks.For example, it may be desirable to the fixed device of the first track fastening first, and may be used also It can need with the second track fastening second fixed device different from the first track.According to this embodiment, may be implemented multiple Track can be facilitated this without multiple guiding pieces, and really by the guiding piece of customization or its component.
1-44 referring to fig. 4, present example may include the first guidance with the first track across multiple apertures 325 Part sleeve 320 may further include the second guiding piece sleeve 320 ' with the second track D and inserting with third track C Enter object.According to this embodiment, can by the surgical guidance part or guiding piece sleeve of insert and type for example described herein, Or it is used together with the guiding piece described in Figure 42-44.The shape of the insert can be generally cylindrical and can be with Size is similarly determined at it can be inserted in guiding piece sleeve and preferably includes at least one contact pin 322,322 ' To be properly aligned and (to be not shown in Figure 41) with the line of rabbet joint.The guiding piece is seated against skeletal anatomy construction and surgery is allowed to cure The raw appropriate positioning for confirming the guiding piece and it is confirmed that the customization of the insert orientation, to provide for dress will to be fixed The orientation being seated in desired position.
The concept of this Additional examples of composition includes (being solved when placing/being attached to patient using at least part of the guiding piece Cut open learn structurally when) come create into patient anatomy construction in extraneous locus.It for example but is not limited, can make Alternative track is determined and created with the following aspect of surgical guidance part described herein without creating new guiding piece:
● the one or more guiding piece conductor；
● the one or more guiding piece sleeve insert；
● holder attachment area；
● the arm (for example, via clip, hole, taking one's seat a little etc.) of the guiding piece.
With may serve to determine second or other multiple tracks with the associated any reference point of upper-part.For example, can To use axis, tangent line, intersecting lens, radius, predetermined marker (for example, radiophotography marker), surface characteristics, end It puts or other can object of reference of the seated position as the orientation for determining the second insert.
Similarly, any known point or geometry on these guiding pieces can be used to create " to block " and enter this and draw To provide another modular part of multiple tracks in guiding element.It is, for example, possible to use the holder attachment regions of the guiding piece Domain is attached " diagonal brace " arm to providing different tracks.This be readily applicable to these arms across the guiding piece, for The hole that the diagonal brace arm is inserted, such as fixing screws hole.
Fixing screws or pedicle screw can be used as additional space alignment features in another embodiment.These are solid Determine screw and pedicle screw is placed in planned specific orientation.Since the length of these screws and direction are predetermined , therefore the track of adjacent segment can be not based on the orientation and feature of these screws.
Alternatively, the position of the fixing screws hole in guiding piece can be used to create other track in surgeon, Include the case where needing or do not need to customize insert.In another alternate embodiment, surgeon be can be used with spy It is orientated the pedicle screw of placement calmly to create other track.
Figure 42 A-B is the plan view from above according to the guiding piece 400 of another alternate embodiment of present disclosure.The guidance Part 400 preferably includes at least first group of guiding piece sleeve 410 and second group of guiding piece sleeve 412.This embodiment especially may be used It is fixed for (for example but being not limited) articulatio sacroiliaca, is partly because patient's match surface data in the mistake of operation It requires in some regions touched not being confirmable in journey.More specifically, in order to reach ilium from two sides, it is desirable that very big Soft tissue exposure, this is excess destruction to normal anatomy.It is guided by using to such as S1 pedicle screw The position of part, so that it may production customization guiding piece track.The track can be determined by using intermediate seated position Orientation, and thus the orientation allows to touch various ilium tracks and rumpbone track, without creating new guiding piece Or the instrument of other custom fabricateds.
In a preferred embodiment, the guiding piece of Figure 42 A-B floats above crista iliaca and not necessarily contacts crista iliaca, this is being gathered around It is desired in certain patients of unstable or sensibility anatomical configurations.Other track can be based on guiding piece set The original orientation of cylinder or guiding piece sleeve insert.In addition it is also possible to realize into other sacral bone structures such as ala sacralis, S2 vertebra Nut or through the track in articulatio sacroiliaca.
According at least one embodiment, the patient contact end of the insert can not be patient's matching type, and according to Other embodiments can provide orientation and the deep-controlled device that will fix is put into through second track.Although Figure 41-44 shows Only one different tracks are gone out, but it will be clearly understood that additional track can be provided with single guiding piece insert.
Figure 43 A is the plan view from above for the guiding piece of three segment surgeries (sacrum ilium adds 1 additional segment), this Figure depicts a pair of of insert with two tracks different from first pair of guiding piece sleeve.Figure 43 B is shown in Figure 43 A The detailed plan view of device.More precisely, the guiding piece sleeve 422,423 that this embodiment provides allows to change and the guiding piece The insert 424 being used together, in order to provide customization and unique track, which is different from one or more of the guiding piece The overall track of a sleeve 422,423.These inserts 424 may include different and/or additional as shown in Figure 43-44 Track or it can alternatively extend outwardly from the ontology of the guiding piece along desired direction, which can not be It is coaxial with the one or more guiding piece sleeve.
This embodiment can also be used in cancer surgery or bone surface is not present or is changed (revision procedure (revision)) in the case where.These additional tracks can be provided with these guiding pieces from multiple adjacent segments.
Referring now to Figure 45, two surgery drilling sleeves 432,434, these surgery drillings are depicted in side elevation view Sleeve can be used together with the surgical guidance part of the alternate examples according to present disclosure.Drilling sleeve is generally known in the art , however, present example is related to customizing drilling sleeve 432,434, these customization drilling sleeves can pass through one or more Patient's matching type insert or guiding piece sleeve are placed so that the contact for providing in the far-end of drilling sleeve with bone surface (is joined See Figure 46).Although customization drilling sleeve 432,434 can be made of any material, preferred embodiment, which will use, to be had enough Intensity and brittleness and be avoided that the metal or metal alloy of fracture and/or the peeling of drilling bush material to manufacture these sleeves 432,434.Correspondingly, drilling sleeve 432,434 can sustain the influence of drill for high-speed without damaging sleeve 432,434 or not Allow the material of drilling sleeve to be deposited on boring sites in curing and is impermissible for reusing for drilling sleeve 432,434.These drilling sets Cylinder 432,434 must also sustain the high temperature encountered in sterilization process.Another benefit of metal sleeve 432,434 is can to use Cutting surfaces carry out " trepan " or machining with allow the distal end 435 " stinging " of guiding piece to the marrow in and fixing means are provided.
Figure 46 is the surgical guidance part 450, guiding piece sleeve 452 and drilling sleeve according to the alternate embodiment of present disclosure The forward sight elevation of 432 component.In this embodiment, the drilling sleeve 432 provided is allowed in the skeletal anatomy of intersection There are gaps between construction and sleeve 432.Alternatively, the edge through trepan of the sleeve or patient-specific edge can provide With more preferably contacting for the bone surface of lower section.
Across these patient's matching type guiding piece sleeves and to enter these drillings in bone without similar angle on the contrary Sleeve provides the additional fixation on guiding piece to vertebra.The convergence that these drilling sleeves pass through insert is also eliminated to additional Fixed needs.It will be clearly understood that for patient-specific guiding piece can provide more or fewer inserts and/or Guiding piece sleeve assists the drilling process in surgical operation, without departing from the spirit of present disclosure.In one embodiment, these Sleeve is disposable, and these sleeves can reuse in other embodiments.
Figure 47 A-D is the Component tray for being used to arrange patient's matching type surgical device according to one embodiment of present disclosure With the view of method.According to this embodiment, Component tray 460 is equipped with multiple patient-specific device D, and which enhance bases Surgical preference or specific surgical operation to the arrangement of multiple device D, structure and arrange validity.
The Component tray provides essential a kind of arrangement for user's success in operating room, including but not It is limited to following factor:
● the segment quantity of surgical operation and specific segment Z1-Z4 (in the case where to use multiple guiding pieces)；
● screw implant for pedicle of vertebral arch diameter and length selection (including optionally changing)；
● one or more navigation guide part corresponding with selected implantation material；
● the combination of guiding piece and/or sleeve, including for concrete application provide at series and/or at the more of monomer A guiding piece.
According to one embodiment, Component tray 460 is made of multiple " area " Z1-Z5, these areas are contained in order in specific section All necessary components required for performing an operation on the specific region of section.It is preferably organized simultaneously in the front tray 460 of surgical operation And these devices D is arranged at desired position, and the facility for sterilizing can also be reached before it will start operation Place.It for example but is not limited, " area " can contain the guiding piece D for specific vertebral levels, insert each of on pallet Enter object I and pedicle screw S.In addition, should can also include the dedicated any drilling sleeve of specific vertebral levels in " area ", solid Determine screw or other attachmentes.The pallet preferably includes the unique tag 462 for specific surgical operation, these labels correspond to Different device, region, segment etc..
These pallets can depend on the scale (that is, 2 segments compare 3 segments) of carried out surgical operation and with different big Small appearance and can be with tape label the segment in area and backbone to match (area 1 will be used for L1) or to include that other are unique Label.For example, these areas can be coloud coding, and from these different correspondence inserts of close control part complementation It can similarly encode in favor of making insert match with guiding piece for some region or segment.In another embodiment In, these components can be provided with bar code, with RFID code or with can by it is appropriate scanning equipment read other solely Feature.
In addition, the pallet provides the safer packaging and orientation of guiding piece.This is to be even more important for plastic guide , plastic guide, may as the fragile property of material and for these different protruding portions made by close control part It needs to protect during transport or steam sterilizing.It is packed to ensure that the size during these committed steps is complete Property.
As described above, some embodiments of present disclosure can be incorporated into cervical vertebra (that is, being carried out on C1 to C7) In the surgical method and instrument of operation.It is described above general due to the similitude of vertebra geometry between waist thoracic vertebrae and cervical vertebra Many concepts in thought can be incorporated into patient's matching type surgical guidance part used in cervical operation.However, to trouble It requires to consider that the uniqueness of the anatomical configurations of cervical vertebra vertebra and surrounding is special when person's matching type cervical vertebra guiding piece is oriented and places Sign, several Considerations therein are discussed about Figure 48-63 below.
Referring now to Figure 48 A-C, one embodiment of present disclosure used in the operation carried out on the C7 of segment is shown. According to this embodiment, cervical vertebra guiding piece 470 includes multiple patient's matching type contact surfaces, and mode allows surgeon should Cervical vertebra guiding piece is accurately and securely placed on appropriate position relative to subjects bones' anatomical configurations.As shown in Figure 48 A, this The cervical vertebra guiding piece of embodiment includes bow or bridge zone section 471 in the intermediate body member of guiding piece 470, which is oriented to be used for It avoids spinous process and is positioned to be in contact with centrum (in this embodiment, at the C7 of segment).Cervical vertebra guiding piece 470 is preferably Including being configured in the preoperative with the first patient-specific surface of the corresponding surface pairings of the first transverse process and in the preoperative It is configured for the second patient-specific surface of the corresponding surface pairings of second transverse process opposite with first transverse process.It should Cervical vertebra guiding piece 470 further comprises first and second supporting legs 472 with corresponding first and second end, wherein first He Second end provides first and second patient for being configured to match with the corresponding part of the first and second transverse process of vertebra The position of specific surfaces.
In one embodiment, first and second supporting leg 472 be it is substantially cylindrical as shown in Figure 48 A-C and It may furthermore is that hollow to allow for sleeve to be inserted.In one embodiment, as above in greater detail, the set Cylinder may include distal end, this distally has after the hollow space that the sleeve is inserted through the first or second supporting leg 472 The patient-specific surface matched with the corresponding anatomical features of patient.In certain embodiments, the sleeve and these supporting legs 472 Including patient-specific surface.In another embodiment, only one in the sleeve and these supporting legs 472 includes that patient is special Property surface.
These sleeves may include the hole for insertion apparatus or instrument or tool (such as screw, Kirschner wire or drill bit) Mouthful.In certain embodiments, guiding piece 470 is oriented to that insertion is allowed to be configured for receiving pedicle screw, lateral mass spiral shell Nail, os integumentale screw or interarticular screw.Other devices that these screws and consideration are used together with the guiding piece of present disclosure can To be standard or can be to be only used for customizing at close control part or specific segment.
As shown in Figure 48 B, which may further include first and second on first and second supporting leg 472 Extension 474, these extensions may include the auxiliary aperture and path for being inserted into such as fixing screws.According to this implementation Example, extension 474 can receive the aperture for being inserted into the extension of perforating and enter the fixing screws in transverse process thus by neck Vertebra guiding piece 470 is fastened in subjects bones' anatomical configurations.It will be clearly understood that can use other kinds of device Temporarily ensure that cervical vertebra guiding piece is just sat on patient, without departing from the novelty of present disclosure discussed herein.
Referring now to Figure 48 C, the plan view from above of the cervical vertebra guiding piece described in Figure 48 A-B is shown.Bow or bridge 471 are shown as avoiding the spinous process, but in an alternative embodiment the lower surface of bridge 471 may further include for this The patient-specific surface of the correspondence surface pairings of spinous process.The example of this embodiment is described below with respect to Figure 54 A.Cervical vertebra draws Guiding element 470 may further include with patient, close control part, the backbone position of the guiding piece will be used or segment, need By the related label of the size of the device of close control part receiving or instrument or tool, the orientation of the guiding piece etc..Scheming Several label examples are depicted in 48A-C.Cervical vertebra guiding piece 470 can also include for receiving the remote of instrument such as inserter The line of rabbet joint, channel, groove or the keyhole at end.
Referring now to Figure 49 A-C, the cervical vertebra guiding piece for being related to using on the C2 of segment of present disclosure another is shown Embodiment.This specific segment of cervical vertebra requires to determine to bridge 491, supporting leg 492 and above with respect to sleeve described in Figure 48 A-C To.Specifically, first and second supporting leg 492 with slightly upward track orientation so as to pass through apparatus for placing, instrument or Tool, the device, instrument or tool are ideally oriented to be in contact with the pedicle of vertebral arch of vertebra.Although this embodiment is not retouched The extension for receiving fixing screws or other devices for making guiding piece 490 temporarily take a seat are drawn, it can be right but it is envisioned that having arrived Cervical vertebra guiding piece for segment C2 provides such extension.As described in Figure 48-49, other than C7 and C2, Other segments are it is also contemplated that using present disclosure.
Referring now to Figure 50 A-D, another embodiment of present disclosure is shown.This specific cervical vertebra guiding piece 500 wraps Include the multiple sleeves 510 for being oriented to receive for receiving the insert (not shown) of such as lateral mass screw.Shown in this tool Body guiding piece is designed to the segment C5 applied to cervical vertebra.As best seen in Figure 50 C, bridge 502 includes for receiving instrument (example Such as inserter) distal end the line of rabbet joint 503.In another embodiment, this part with the line of rabbet joint of bridge 502 can be in middle area It include the connector for two sseparated parts of the cervical vertebra guiding piece to be connected in domain.Pass is described referring to Figure 53 A-E In the further details of this specific embodiment.Other than the patient-specific supporting leg shown in Figure 50 C-D, this embodiment into One step includes the first and second contact pin 520 for being placed below the lamina surface of vertebra.These contact pin 520 auxiliary draws cervical vertebra Guiding element is fastened to patient-specific anatomical and structurally and in next section is described in more detail.
Referring to Figure 51 A-C, other views of discribed embodiment in Figure 50 A-D are shown.According to this embodiment, this A little contact pin 520 are oriented to separate zygapophysial joint capsule when cervical vertebra guiding piece 500 is placed in position and enter joint tip out In section.It is matched that the one or both sides of these contact pin 520 can be patient.These patients, which match contact pin 520, can enter joint Both provide above or below tip out section or in certain embodiments.In this embodiment shown in, these contact pin 520 create interference fit with the zygapophysial joint and fasten the cervical vertebra guiding piece in place.These contact pin 520 can be by fitting It is made together in the material of flexure, to allow interference fit described above, this can be its remaining part with the surgical guidance part Divide identical or different material.These contact pin 520 can also be made of non-compliant materials, thus scratching using the guiding piece material Property allows interference fit described above.
Referring now to Figure 52 A-C, one embodiment of present disclosure is shown, this embodiment depicts the bridge 502 with the line of rabbet joint, The bridge further comprises the aperture 504 for holding device (such as fixing screws), and the device is placed into this embodiment In spinous process.In one embodiment, which is threaded, and in another embodiment (as drawn in Figure 55 B) it It is not such.The aperture 504 may further include particular track, the e.g. tool in order to which cervical vertebra guiding piece to be fixed to cervical vertebra In body section and by the way that fixing screws shown in Figure 52 A-C are oriented in as desired in more upwardly direction.Figure Embodiment shown in 52A-C also can be incorporated into the implementation including the patient-specific surface on the lower surface of bridge 502 In example, the patient-specific surface be used for the corresponding surface pairings of the spinous process, such as about Figure 54 A described embodiment.
According to an alternate embodiment, cervical vertebra guiding piece described above may further include locked plug-in unit.Referring to Figure 53 A-E, such embodiment may include the second section that guiding piece is locked to for the first section 525 by guiding piece Device on 527 and further comprise being oriented to the first set paired with each other around specific anatomical features (such as spinous process) Ring section 526 and the second collar segments 528.First and second section 525,527 and the first collar segments 526 and the second lantern ring Section 528 can be connected by proper technology known in the art, including but not limited to by inserting one or more contact pin Enter in the complementary line of rabbet joint on adjacent surface, as shown in Figure 53 A-C.By this method, by first by the first of cervical vertebra guiding piece It is placed in position with the second supporting leg and then the first and second sections 525,527 of the guiding piece is connected, first and secondth area The connection of section 525,527 can allow to be interference fitted.Interference fit be due to the guiding piece the first and second sections 525, 527 are connected and first and second supporting leg (and corresponding first and second patient-specific surface) is held in position against trouble Caused by tension when person's skeletal anatomy constructs in first and second section.In addition to interference fit other than or replace in This, can make one or more pins and/or screw across the first and second sections 525,527 of the guiding piece so as to It is connected to stiff member.These pins and/or screw can also pierce through spinous process or vertebra anatomical configurations it is any its His part, in order to stabilize changing the guide assemblies and securing it on bone.Although the first and second lantern ring shown in the drawings Section 526,528 do not have patient-specific surface, but it will be clearly understood that include this be characterized in present disclosure range it Interior.
As mentioned above, these cervical vertebra guiding pieces can further include being used for and spinous process on the low portion of the bridge The patient-specific surface of pairing, as discribed in Figure 54 A-C.The patient-specific surface be it is substantially concave, with In the complementary male surface for receiving the spinous process being located at below the position of the bridge.The cervical vertebra guiding piece can be in certain embodiments Including the line of rabbet joint, channel, groove or the keyhole for receiving the distal end of instrument (such as inserter).It is depicted in Figure 54 B-C and neck The exemplary inserter of the portion paired with the line of rabbet joint of vertebra guiding piece.As seen in best in Figure 54 C, the distal end of the inserter can be with It is pitched including two teeth, one of tooth fork can be accepted in the line of rabbet joint on the bridge of the guiding piece, and another tooth Fork is placed on the lateral side of the bridge.The inserting instrument can also rotate 180 degree to allow the second tooth fork to be placed on this On the opposite lateral side of bridge.In certain embodiments, these teeth fork may include the inner surface containing texture or multiple small contact pin, So as to grab into wherein one or more surfaces of the bridge or with the complementary sockets in the surface of the bridge (in Figure 54 C not Show) it is in contact or becomes to link therewith.
According to still another embodiment, which be may further include for placing institute in such as Figure 55 A-C Show one or more apertures of the fixture of type.Fixture 540 can be short by providing the correspondence screw thread of threaded bores and fixture 540 Column is locked to appropriate position to fasten and tighten and can have threaded stud and corresponding nut for fixture 540.Such as figure Shown in 55B, fixture 540 can be positioned on the anatomical surface of vertebra and then by the threaded stud and bolt Or nut and be tightened in the position of fastening, the situation in the embodiment as shown in Figure 55 C.More than one fixture can be provided 540 to improve the movement that this fastens cervical vertebra guiding piece.By it is this it is identical in a manner of, can to the cervical vertebra guiding piece provide one Or multiple contact pin or hook be to be fastened to subjects bones' anatomical configurations for the guiding piece, as shown in Figure 59 A-B.It is practicing In, fixture 540 or hook can be placed on desired position and place first, and then the guiding piece is reduced and is made The short column or hook for obtaining fixture 540 enter among the correspondence aperture on the guiding piece.Once the short column passes through the aperture (as schemed Shown in 55C and 56C-D) positioning, so that it may nut thread is connected in the threaded stud and is tightened to draw the cervical vertebra Guiding element is fastened on patient anatomy structurally.
As above for described in Thoracolumbar disk guiding piece, cervical vertebra guiding piece described herein can be provided into patient spy Axial in anisotropic anatomical configurations or the alternatively track of off-axis.It can be to above-described and scheming now Sleeve 550 shown in 57 provides the track of such off-axis.The track can be filled by using above-described scanning It is standby to be selected to determine and be based on best patient anatomy construction, bone density etc..The track of the off-axis is in cervical vertebra Following region in can be especially important, herein, usual lesser vertebra is impermissible for these supporting legs or corresponding sleeve quilt It is positioned to so that needing the desired axis of the device being used together with guiding piece, instrument or tool with coaxial relation reality It is existing.By providing the track of off-axis, which can be used for fastening device or allowing by tool or instrument Along the direction insertion that will be unable to realize in other cases.
The embodiment for the present disclosure described in Figure 58 A-C includes patient-specific guiding piece calibrating patterns.The model is given User provides the vision of patient anatomy's construction and tactile and indicates, to create patient-specific guiding piece, including one or Multiple predetermined screw trajectories.To the modeling of predetermined screw trajectories facilitate patient's matching type surface orientation and The direction of these components (that is, supporting leg, sleeve, insert etc.) of placement and the guiding piece.By using the model, user Non-patient-specific guiding piece that is adjustable and can reusing can be created.One example of this respect can be with hinge, The surgical guidance part of ratchet, revolving meber, pivotal part, holding screw etc., these when being adjusted or rotating " engagings " are in place simultaneously Once and user has completed its adjustment and can be locked.Then, guiding piece sleeve can be placed on to these bolts outstanding With drill bit/screw tap/screw trajectories desired by providing (as shown in Figure 58 A-C) on nail 560, and the rest part of the guiding piece can be with It is freely configured or is configured to by user to realize the best fit for learning construction with patient-specific anatomical.
Figure 59 A-D shows another embodiment of surgical device, which can be preferably used for being related to patient The operation of cervical vertebra.According to this embodiment, these devices include multiple sleeves 572, and one of multiple sleeve 572 or More persons can receive selectively removable clip, such as clip 574 shown in Figure 59 C-D.It in one embodiment, is logical Crossing will receive these selectivity removable in the line of rabbet joint 571 that short column 573 associated with clip 574 is put into the ontology of the sleeve The clip 574 removed, as shown in Figure 59 A.This receiving can be frictional fit, but more preferably buckle or the attachment of bolt button, This attachment prevents from removing in clip 574 once the device has been positioned in patient anatomy structurally.It is contemplated that with This embodiment is used together other connections that those familiar with ordinary skill in the art are grasped.
Figure 60 A-C includes the other view of the device described in previous paragraph.Figure 60 A is the side elevational of the device Figure, which, which has, engages with the ontology of the sleeve of the device and further engages with the bottom side of adjacent bone structures At least one clip 574.Here, the bone structure is the vertebral plate of neck bone, but it is also contemplated that these clips are used for other solutions Cut open feature.Figure 60 B shows the device with two clips 574 ' for being similar to clip 574 ' shown in Figure 59 D.Figure 60 C is shown The details that is connect between these clips of the device and sleeve according to a specific embodiment.
Figure 61 A-C shows the still another embodiment of guiding piece and associated clip.Here, these clips 575 are preferred Ground is spring clip and is biased under normal circumstances with the distal end of these clips to deviate from sleeve body, such as institute best in Figure 61 A See.Connection between these clips 575 and sleeve of guiding piece so that, these clips 575 can be forced into the sheet of these sleeves On body or it is pressed into the ontology of closer sleeve, normal bias associated with clip causes resistance to it.Once it is depressed, this A little clips 575 can be inserted under adjacent anatomical feature, as shown in Figure 61 B-C.In this embodiment, these clips 575 may be oriented to cause not to associated patient anatomy construction, herein for the processus articular superior joint of patient's vertebra Desired damage.By the way that the distal end of clip 575 to be placed in processus articular superior complex, clip 575 can wedge skeletal anatomy It is not passed through anatomical configurations between construction and in other cases patient is caused to damage.Although clip 575 and sleeve it Between attachment be depicted as permanent attachment, selectively can remove but it is envisioned that having arrived clip 575 shown in Figure 61 A-C and can be , as described in the embodiment in Figure 59 and 60.
Figure 62 A-E shows the view of the still another embodiment of the device of Figure 59-61.According to this embodiment, these It is attached on rigid connector 576 so that the ontology relative to the device is adjusted to 575 property of can choose of clip.According to excellent Select embodiment, adjustment can be carried out by the threaded stud 577 in the correspondence threaded hole that is inserted on the surface of the device, such as be schemed Best seen in 62A-B.Threaded stud 577 preferably results in the rotation of multiple cam members relative to the positioning of the device, this Surface of a little elements in turn around patient anatomy's construction provides rigid contact point.
The adjustment of threaded stud 577 can also allow user that the distal end of clip 575 is selected with patient anatomy Engages and be disengaged to property.In one embodiment, this adjustment is to make to press from both sides by short column 577 and rigid connector 576 Son 575 away from the device ontology and caused by, as best seen in Figure 62 B and 62D.Rigid connector 576 could be attached to Each of multiple clip 575, as shown in Figure 62 A-E, which preferably includes the far-end positioned at each clip Cam member 580.It has been susceptible to other of rigid connector 576 for being used together with this embodiment and has connect and be orientated.
Clip described above can be tapered or point so that the distal end of clip contacts and penetrates patient anatomy's structure The bone surface made.In other embodiments, these clips may further include textured or machined surface, the table Face connects with patient anatomy's construction, and creation is frictionally engaged therewith for merging.It can become in conjunction with other surfaces in the design of clip Change and geometry is to improve the connection with patient anatomy.
These clips are preferably not patient-specific, but they may include patient-specific surface, this is to wish It hopes.These clips are also possible to the substantially deformable difference to comply with patient anatomy's construction.These clips can also be with It is permanently or selectively attached on the insert of the device, the sleeve without being attached to the device described above On.
Device in one embodiment can further allow for spacer, in such as Figure 63 A-H it is discribed that It engages.Spacer 590 may include such as the patient-specific surface of one or more shown in Figure 63 A-B or can be made It is made in a variety of different applications.In spinal surgery, spacer 590 allows device to have around the more of patient spine The patient-specific surface of a segment.Spacer 590 is preferably also coupled on the device, as best seen in Figure 63 C-E.This Spacer in a embodiment, which provides, to be used for the device and desired anatomical configurations and/or guiding piece described above Element is orientated another being aligned or multiple surfaces.
It has been described under the background of cervical operation for convenient above with respect to concept described in Figure 48-63, But they are not limited to apply in cervical vertebra and can also be applied to chest waist sacrum backbone and ilium.
Referring now to Figure 64-67, multiple and different embodiments according to an aspect of the present invention, these embodiments are shown The device for being related to seal wire/guide pin and being intubated, such as screw and corresponding instrument and/or implantation material.According to these implementations Example, surgical guidance part described above may further include " intubation " system, wherein Kirschner wire or guide pin/seal wire are worn One of these sleeves associated with patient-specific guiding piece or insert are crossed to place, and any subsequent instrument and/ Or implantation material is guided using this thread and enters its appropriate position along the longitudinal axis of this thread.
Referring to Figure 64-65, guiding piece has received multiple instrument sleeves, and each instrument sleeve has for receiving silk 600, the vertical passage at center preferable through each insert, the vertical passage can be used then to make other instruments And/or implantation material is placed in the middle.As shown in Figure 66, these instrument sleeves can extend above the top surface of guiding piece, this in turn can To accommodate longer seal wire 600 and stablize this thread during silk 600 is inserted into subjects bones' anatomical configurations In appropriate position.
Next, can be such as these instrument sleeves of removal discribed in Figure 67.If guiding piece assisted surgery doctor Surgical operation is carried out, then can retain the surgical guidance part.It is envisaged however that be once these silks 600 as shown in Figure 68 It appropriately takes a seat, so that it may completely remove the guiding piece.
Once these silks 600 are in place, one or more instruments or implantation material, such as intubation screw, so that it may by these silks 600 receive and are thus placed in appropriate position and track.It further illustrates but is not limited, can will include at least one The intubation screw in a hole through it is located on the silk 600 established by guiding piece discribed in Figure 64.It should be expressly understood that Be, these embodiments other than being intubated screw can also using other implantation materials and various instruments, including with On those of enumerate and constitute a part of present disclosure.
Now in more detail referring to Figure 69-73, the device for carrying out MIS operation on centrum is shown.The device includes Generally cylindrical hollow retractor 692, the retractor have a first end and a second end.The ontology of retractor 692 is spread Its longitudinal axis be it is hollow, this enables retractor 692 to receive expander and opens retractor described above gradually It opens and is further able to receiving tool, instrument or device and pass through, the insert including customization or standard production is such as schemed Shown in 69.The first end of retractor 692 receives one or more patient-specific end pieces with being preferably designed to pairing property 694, these end pieces are also shown in Figure 69.Retractor 692 can also include preferably along the generally round of retractor 692 Attachment connector that the outer wall of cylindrical body positions, for receiving coupling arrangement 710.
Coupling arrangement 710 has the line of rabbet joint or groove for receiving one or more attachment connectors preferably on every end. In one embodiment, which is complementary and the wound in connection with the line of rabbet joint of specific coupling arrangement 710 or groove Build firm connection.In certain embodiments, the connection that is attached between connector and the line of rabbet joint or groove of coupling arrangement 710 so that, Once the connector and groove or the line of rabbet joint match, the desired angle for just realizing coupling arrangement or direction are (such as institute best in Figure 72 See).In one embodiment, which is locked out connection.In another embodiment, which is to snap fit attachment.? In another embodiment, which is the frictional engagement between the connector and groove or the line of rabbet joint.It is further elucidated above, referring to figure 95-97。
Coupling arrangement 710 can be used to one or more retractors 692 are secured to one another and exist in a preferred embodiment It is connected above patient skin surface (that is, endermically).The size and shape of coupling arrangement 710 can be determined that for inciting somebody to action First retractor 692 and the second retractor 692 are secured to one another in desired position.According to still another embodiment, can incite somebody to action Coupling arrangement 710 is fastened on one or more retractors 692 to provide desired orientation or track for related insert.Connection Connection device 710 may be also used in multi-segmental MIS operation and can be attached to other connections according at least one embodiment and fills It sets so as to both lateral and longitudinal gaps fixed in 692 array of retractor.
Insert 695 can have the shapes and sizes of variation and may include for example and above for Fig. 1-68 institute The feature of the associated feature of the insert of description.The different views of instrument described above are shown in Figure 70-73, and Including being related to the embodiment of multi-segmental MIS application.
Referring now to Figure 74, the embodiment similar to Figure 69-73 is shown, in addition to coupling arrangement includes multiple channels, this It is that a little channels are preferably the ontology custom fabricated across coupling arrangement 710 and one or more alignment elements can be received 695.These alignment elements 695 can be fixing pin, as shown in Figure 74, and for fastening component shown in Figure 74 Structurally to specific skeletal anatomy.The variant of this embodiment is depicted in Figure 86 A-C, these variants include custom fabricated Channel, these channels be oriented to for guide alignment element penetrate patient's vertebral plate, articular process, small portion (pars), spinous process or Other anatomical features.In addition, these channels may be provided in different or multiple positions, such as shown in Figure 87 A-B Those positions, this provides above-described benefit in the case where needing coupling element.In some embodiments it is possible to mutually tie It closes ground and uses channel in coupling element and in the ontology of retractor, as shown in Figure 88 A-B.
These alignment elements 695 can also include first size and the second size, these sizes are provided to surgeon Estimate the ability of the depth of the alignment element.For example, alignment element 695 may include lantern ring, the lantern ring is than the alignment element First size is thicker, to prevent the alignment element 695 from penetrating in skeletal anatomy construction.
Referring to Figure 75, another embodiment is shown, wherein the component further comprises for linking two or more The bridge element 715 of coupling element 711,712.In this embodiment, bridge element 715 and coupling element 711,712 create more Stable component.Equally as shown in Figure 75, the insert of each retractor tube shown in being used for includes different shape and size Opening, to adapt to different tools, instrument or device.By this method, the insert of customization can be and specific retractor tube phase Associated concrete application institute is dedicated and only receives specific tool, instrument or device.
Referring now to Figure 76 A-C, the alternate embodiment of surgical device is shown.It in this embodiment, preferably can be again The handle used includes the first and second parts 732,734, is coupled to each other and is attached to this to these part property of can choose On device.This handle is preferably attached on the device in micro-wound surgical operation and to associated one or more Device provides both alignment and stability.First and second parts 732,734 of the handle preferably include convenient for user's The ergonomic shape of gripping with one hand and deviate the vertical axis of the one or more device preferably to avoid in surgery User's sight is interfered during operation.Alternatively, these handle portions 732,734 can be belt profile and/or angled To avoid interference user's sight.Although be the connection with the line of rabbet joint shown in Figure 76 A-C, it is contemplated that by these hands Handle portion 732,734 is connected to other means on the one or more device.Specifically, implement shown in Figure 76 A-C It can be in conjunction with the hereafter difference attachment device described in Figure 95-97 in example.
Figure 77 A-G is depicted including the another of one or more optional alignment/depth/position control component surgical devices One alternate embodiment.Here, handle includes at least the first and second parts 732,734, these parts can be relative to that This positions to adjust the width of the handle with multiple positions.At least one of first and second part 732,734 includes The label 744 of width is indicated with known dimensions.The device of Figure 77 A-G preferably includes at least one rotation adjustment part 742, this appearance Perhaps the angle of the handle is changed according to the desired orientation of one or more devices.The handle is preferably coupled to be placed into On one or more inserts in one or more devices (being not shown in Figure 77 A-G).Preferred embodiment further includes one A or multiple deep-controlled adjustment elements 740, as shown in Figure 77 C.This allows these " supporting legs " of the device to translate.The device is excellent Selection of land includes the label about supporting leg, these labels reflect known dimensions, for for specific operation and patient anatomical It learns when construction adjusts the device and is easy to use.
Figure 78 A-B depicts adjustment guiding piece 790,792, these adjustment guiding pieces auxiliary realize desired angles and/ Or width and/or height adjust.These adjustment guiding pieces 790,792 are preferably coupled on the supporting leg of the handle or the device And it is fixed when realizing desired position or orientation in place.For example, can be placed on by the way that guiding piece 790 will be adjusted Width is set on handle, as best seen in Figure 78 B, once the adjustment guiding piece is fastened to position, the adjustment guiding piece is just Prevent the movement of handle.Similarly, angle adjustment guiding piece 792 is used as chock and is once securely placed the device On just prevent larger or smaller rotation of these supporting legs relative to handle (as shown in Figure 78 B).
Figure 79 A-B includes the view for determining the device of notch and entry position to specific surgical operation for auxiliary needle. The device preferably includes at least one reference element 802, which can be aligned with known anatomical features.? This, this feature is the center line of patient spine and/or the longitudinal axis of spinous process.The device further comprises height, width and angle Degree adjustment 803,800,806.Angle adjustment 806 be it is associated at least one guiding elements 804, which can root Desired position is rotated or is pivoted to according to user preference.The guiding elements 804 is preferably still height-adjustable and can be into One step include include the distal end for marking surface, the label surface allow user marked with patient desired position so as to Reference in future.The label surface, which can be, directly or indirectly to be contacted with laser or other optical markings devices.Figure 79 B describes According to the device in final position of this embodiment, wherein being directed to associated operation, which is to be in In desired position and downwardly directed patient anatomy constructs.Figure 80 is the detailed view of the device of Figure 79 A-B.
Referring now to Figure 81 A-C, another example of embodiment is provided, wherein attachment connector and coupling arrangement 710 Connection between the line of rabbet joint or groove so that, once the connector and groove or the line of rabbet joint match, just realize the desired of coupling arrangement 710 Angle or direction.Referring again to the Figure 69-75 described before.Figure 81 A-C also illustrates one embodiment, and wherein these lead Opening device can be coupled across spinous process and between the different segment of patient spine.Also it is expressly contemplated that this implementation Example other variants used in non-spinal operation.In addition, as discussed in more detail above, these retractors and connection member Part 710 and bridge element can also include one or more unique tags, these labels are to surgeon or other healthcare givers Identification information is provided so that it is guaranteed that each component of specific component is assembled into appropriate position and is attached on appropriate instrument.
In some applications it may be desirable for providing expansible retractor tube to surgeon, such as shown in Figure 82 A-84C Embodiment.In this embodiment, the retractor tube 820 of the gathering in first orientation is shown with Figure 82 A and ratio is in The retractor of the second orientation as shown in Figure 82 B has smaller section.The retractor of Figure 82 A can pass through lesser notch It is inserted into and learns feature pairing with patient-specific anatomical.It, can for example for example after by retractor 820 appropriately positioning But it is not limited, makes by using with the instrument provided together of retractor 820 or tool (being not shown in Figure 82 A-B) Retractor 820 opens.Once retractor 820 is located in its second position, so that it may by additional instrument, tool, device Or even retractor positioning passes through, as shown in Figure 82 C.Referring to embodiment shown in Figure 82 A-D, the expansible retractor 820 may further include the means for being attached patient-specific end piece 825, such as above with respect to described by Figure 69-73 's.
The variant of this embodiment described in the last period is depicted in Figure 83-84.According to these embodiments, pass through edge Multiple longitudinal hinges for placing of internal circumference of retractor tube, the retractor tube be it is expandable, such as institute best in Figure 84 B Show.These hinges can be mechanical hinge or can be hinges (that is, being formed by the material of the retractor tube).At it In his embodiment, it can be combined with the variant of hinge, without departing from the novelty of the embodiment described herein.In certain realities It applies in example, which is disposable.In other embodiments, which can reuse.
Referring now to Figure 85, equipped with retractor tube described herein insert may further include it is modified The longitudinal hole of size, the hole allow securely and effectively to apply one or more surgical tools or instrument in practice.For example, such as Shown in Figure 85, insert 830 can provide safety stop or deep-controlled stop part 832 (that is, anti-by means of its geometric configuration It is more than some depth that only instrument or tool move ahead in the longitudinal hole of the insert).It is patient-specific according to another embodiment End piece 834 can provide the ability for preventing instrument or tool from extending over controlled depth.
Referring now to Figure 89 A-90C, it is often desirable that be when carrying out MIS operation be located at patient spine multiple segments Connector 900 is provided between the retractor of surrounding.As shown in Figure 89 A-B, one embodiment of present disclosure is to provide for following Connector 900, the connector further comprise time of the additional retractor tube 910 for being located between two adjacent retractor tubes Level position.The two adjacent retractor tubes (including its being fixedly secured with subjects bones' anatomical configurations) with by Figure 89 A-B Shown in connector 900 provide rigid structure combination for by additional retractor 910 be inserted through the two positioning Secondary location between retractor provides well-defined reference point.This additional retractor 910 then can be used in example As carried out additional surgical procedures at the position between two adjacent vertebraes, without the retractor is additionally fixed to patient's solution Cut open structurally.
Referring now to Figure 91 A-92D, other a variety of different realities are shown about above-described retractor and related elements Apply example.One embodiment as shown in Figure 91 A-D provides adjustable coupling element 920.Adjustable feature may include But it is not limited to length, width, height, deflection and depth.In this embodiment, it does not need to be pre-configured with patient-specific Coupling element or bridge, and the adjustable coupling element can be and can reuse.In one embodiment, trouble can be used Person's specific data provides specific setting to surgeon, for being adjusted to the adjustable coupling element 920 specific Desired setting used in MIS operation.This data can provide and including particular surgical hand before MIS operation Art plan including or do not include that any patient customizes instrument.
Diversified mechanical property can be combined in above-described coupling arrangement, draped over one's shoulders without departing from what is made herein The spirit of dew.By U.S. Patent Publication No. 2009/0105760, (the disclosure is co-pending and by George to the applicant Doctor Fu Lei (George Frey) is named as sole inventor) be incorporated herein with entire contents by quoting, the purpose is into The additional support of one step supplement present disclosure and offer for a variety of different mechanical properties that can be used in the coupling arrangement.
Another embodiment is shown in Figure 93 A-D, which provide the templates of surgical tool, instrument or device, should Template can be customization or belt profile to be consistent with the anatomical configurations of particular patient.In certain embodiments, the mould Plate can provide the specific size, shape, orientation etc. of a device such as bar to surgeon, as shown in Figure 93 A-B.? In still another embodiment, which can be device shown in such as Figure 93 C-D.
Figure 94 A-C is multiple and different views of one embodiment of present disclosure, which includes multiple patient-specific Guiding piece.Multiple guiding piece can receive instrument (such as discribed inserter in Figure 54 B) and be manipulated by the instrument.Substitution Ground, multiple guiding piece can receive multiple elongated shafts or " indicator " to assist user by the lower section anatomical configurations with patient Associated position, orientation, curvature and/or deformity visualization.Here, lower section anatomical configurations are the slave T10 to L4 of patient Backbone.These indicators create the visual pattern of deformity associated with these segments of patient spine.In addition, these are indicated Device allows surgeon to determine for correcting deformity or otherwise treating the fixed link of the patient or the length of other implantation materials Degree and orientation (including curvature) and can also be for determining correction, rod-shape/length or the purpose for being properly positioned guiding piece And it is captured by optical system digitally to reproduce the curvature.These indicators can assist using in terms of other of surgical operation Family.For example, Figure 94 C shows the side elevation view of multiple indicator, this allows surgeon by each section of patient spine Section difference in height and from a segment to the difference of another segment visualize.These indicators also allow user to see Whether specific patient-specific guiding piece is unjustified or misplaced.
Figure 95 A-C is vertical according to the side view of the connector for being attached on sleeve or insert of the embodiment of present disclosure Face figure.This connector includes threaded hole, the threaded hole by threaded stud receive and be threadably engaged and in rotational sense On be fastened on the short column.This connection type can use in different ways, alignment including but not limited to described herein Connection between device and surgical guidance part device.Figure 96 A-C is shown according to another alternate embodiment of present disclosure Clamping connector.Figure 97 A-C shows the screw or pin connector of the still another embodiment according to present disclosure.Here, should Screw is inserted through the line of rabbet joint in ferrule element and is further inserted through in the distal end of instrument associated with the device The line of rabbet joint.For example, the instrument may include the supporting leg of alignment means, such as those described above.
Figure 98 A-C is the side perspective of the insert and guiding piece sleeve according to one embodiment of present disclosure.Here, The insert includes a reference marker object, which may include notch, groove, recess, scratch or for should Insert snaps to desired other markers being orientated.The marker preferably with the naked eye and passes through fluoroscopy all It is visible and can be visible by other known scanning technique.This embodiment for by insert be aligned with In receiving cutting or drilling instrument or for particularly useful for being inserted through implantation material wherein.
Figure 99 A-G shows the system for guiding piece to be aligned according to one of these different embodiments described herein Different views.This system further comprises adjustable arm component, which can be attached on surgery surface or replace It is attached to patient to generation.Figure 99 A shows arm component to leave the first position of one or more devices, and Figure 99 B is shown It is attached on one or more devices to provide the arm component of stability and on patient skin by placing.This or User setting and fixation when carrying out surgical operation on patient spine are allowed in this attachment between multiple devices and the arm component The sagittal angle of the one or more device.Figure 99 C shows the perspective view of the embodiment of Figure 99 A-B.
Figure 99 D-E shows alternate examples, and wherein the arm component includes the telescoping member placed on patient skin, The telescoping member can be adjusted to desired length and angle relative to associated one or more devices.This be used for The handle is held in place when family does not grasp the handle of the one or more device.Figure 99 F-G depicts the arm component again Another embodiment, wherein the component is attached to operating table or side tables above or on other horizontal surfaces.In these embodiments Each embodiment preferably include locking mechanism for once by the arm once having built up desired orientation and position Component parts fastening is in place.
Figure 100 A-D is the side perspective according to the transdermal delivery device of one embodiment of present disclosure.The device is preferred Ground includes having expansible/shrinkable tip distal end.When in the first position as shown in Figure 100 C, which can be with It is inserted through any guiding piece and/or insert described herein.After the insertion, which can open as shown in Figure 100 D It opens and is locked in deployed position.The axis of the device may further include for preventing insertion guiding piece and/or insert In be more than desired distance lantern ring.
Figure 101 A-D be according to present disclosure again another alternate embodiment patient-specific guiding piece it is multiple not Same view.In this embodiment, the patient contact surfaces of the guiding piece further comprise surface contacting element.These elements can To engage the soft tissue around such as lower section bone surface and be beneficial for penetrating soft tissue.These elements additionally provide Better stability and touch feedback is improved, this allows for user to determine whether the guiding piece is in correct position. In a preferred embodiment, the shape of these contact elements seems barb or blade, but can have difference in other embodiments Sharpness, radius, length and orientation.
Although device described above has been shown as being used together with certain guiding piece screws and/or instrument, answer It is expressly understood that, these devices can be used for varied other implantable and not implantable instruments, for example wrap Include the pedicle screw (commonly referred to as cortex bone track screw) placed from centre to two sides.It can be with above-described surgery Device is used together other screws and instrument without departing from the range of present disclosure and is considered in the appended claims model Within enclosing.
Although a variety of different embodiments of present disclosure have been described in detail, it should be clear that the technology of this field Personnel will occur to a variety of modifications and changes to those embodiments.However, it should be clearly understood that such modifications and changes It is in the scope and spirit of the present disclosure as illustrated in following following claims.In order to further show, this application claims it Information provided by these temporary and non-provisional patent applications of priority and material clearly constitute a part of present disclosure simultaneously And entire contents are incorporated herein by quoting.
Although in addition, fusion bracket of the invention particularly suitable between two targeted vertebras be implanted into backbone in, and Although many discussion of the invention are for the use in backbone application, by may want to fusion two in patient's body Or more the other positions of bone structure be implanted into advantage provided by the embodiment of the present invention also may be implemented.Art technology Personnel it will be recognized that the present invention in bone repair and the general field for the treatment of have application, be applied especially to spinal injury and The treatment of disease.It will be appreciated, however, that the principle of the present invention also can be applied to other field.
It will be clearly understood that when describing these different embodiments of present disclosure using term " patient ", the term It should not be interpreted in any way as being limited.For example, patient can be human patients or animal patient, and described herein Instrument and method are applied equally to veterinary science, the surgical operation for being suitable for structurally carrying out in human anatomy just as them Equally.Therefore, instrument described herein and method have the application beyond the surgical operation used by spinal surgeons, and These concepts can be applied to other kinds of " patient " and perform the operation, without departing from the spirit of present disclosure.
The discussed above of present disclosure has been proposed for the purpose of illustration and description.It is not intended to above by present disclosure office It is limited to one or more forms disclosed herein.In the above-mentioned detailed description for citing, for the purpose for simplifying present disclosure, The different features of present disclosure are combined in one or more embodiments.This method of present disclosure should not be solved It is interpreted as reflecting intention following in this way, that is, the present disclosure of required right is needed than clearly describing more in each claim More features.But as the following claims reflect, what is relied upon in terms of invention will be less than single foregoing disclosure Embodiment all features.Therefore, following claims is expressly incorporated in this detailed description, wherein each right is wanted Seek the independent preferred embodiment relied on own as present disclosure.
The present invention include in a variety of different embodiments substantially as this describe and described in component, method, process, System and/or instrument, to include a variety of different embodiments, its sub-portfolio and its subset.Those skilled in the art are resonable It is readily apparent that how to manufacture and use the present invention after solution present disclosure.The present invention is included in a variety of different embodiments to be not present This do not describe and/or the item that describes in the case where, or in its multiple and different embodiment, including the device before being not present Or device and process are provided in the case where the such item that may have been used in the process, such as improving performance, realizing Convenient and/or reduction cost of implementation.
Moreover, although present disclosure has included the explanation of one or more embodiments and certain change and modification, Other change and modification are also within the scope of present disclosure, for example, as may be in this field after understanding present disclosure Within the scope of the skills and knowledge of technical staff.This is intended to obtain the power including alternate embodiment in allowed limits Benefit, including interchangeable and/or equivalent structure, function, range or the step for those of required substitution, regardless of Interchangeable and/or equivalent structure, function, range or the step of such substitution whether be disclosed herein be in this way, and It is not intended to dedicate any patentable theme to publicly.
Priority Applications (4)
|Application Number||Priority Date||Filing Date||Title|
|US14/298,634 US9198678B2 (en)||2013-03-15||2014-06-06||Patient-matched apparatus and methods for performing surgical procedures|
|PCT/US2015/032356 WO2015187397A1 (en)||2013-06-07||2015-05-26||Patient-matched apparatus and methods for performing surgical procedures|
|Publication Number||Publication Date|
|CN106659524A CN106659524A (en)||2017-05-10|
|CN106659524B true CN106659524B (en)||2019-02-12|
Family Applications (1)
|Application Number||Title||Priority Date||Filing Date|
|CN201580041253.6A CN106659524B (en)||2013-03-15||2015-05-26||For executing the patient's matching type instrument and method of surgical operation|
Country Status (1)
|CN (1)||CN106659524B (en)|
Family Cites Families (3)
|Publication number||Priority date||Publication date||Assignee||Title|
|US7717943B2 (en) *||2005-07-29||2010-05-18||X-Spine Systems, Inc.||Capless multiaxial screw and spinal fixation assembly and method|
|US8105356B2 (en) *||2007-06-05||2012-01-31||Spartek Medical, Inc.||Bone anchor with a curved mounting element for a dynamic stabilization and motion preservation spinal implantation system and method|
|EP2588009B1 (en) *||2010-06-29||2018-12-26||George Frey||Patient matching surgical guide|
- 2015-05-26 CN CN201580041253.6A patent/CN106659524B/en active IP Right Grant
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|REG||Reference to a national code||
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