CN1997329A

CN1997329A - Open wedge osteotomy system and surgical method

Info

Publication number: CN1997329A
Application number: CNA2005800224251A
Authority: CN
Inventors: V·P·诺沃克
Original assignee: IBalance Medical Inc
Current assignee: Arthrex Inc
Priority date: 2004-05-07
Filing date: 2005-05-06
Publication date: 2007-07-11
Anticipated expiration: 2025-05-06
Also published as: CN100471471C

Abstract

Surgical apparatus and methods for open wedge osteotomy surgery. The apparatus comprises a multi-part osteotomy implant with first, second and third components and connection mechanisms. The methods for performing an open wedge osteotomy comprises a cutting guide, mechanical jack and a multi-part implant.

Description

Open wedge osteotomy system and surgical method

With reference to unsettled existing patent application

Present patent application requires the priority of following patent application:

(1) unsettled existing U.S. Provisional Patent Application sequence number 60/569,545, VincentP.Novak proposed on May 7th, 2004, OPEN WEDGE OSTEOTOMY SYS TEMAND SURGICAL TECHINQUE (lawyer's case NOVAK-1 PROV) by name;

(2) unsettled existing U.S. Provisional Patent Application sequence number 60/603,899, VincentP.Novak proposed on August 24th, 2004, OPEN WEDGE OSTEOTOMY SYSTEMAND SURGICAL TECHINQUE (lawyer's case NOVAK-2 PROV) by name;

(3) unsettled existing U.S. Provisional Patent Application sequence number 60/626,305, VincentP.Novak proposed on November 9th, 2004, OPEN WEDGE OSTEOTOMY SYSTEMAND SURGICAL TECHINQUE (lawyer's case NOVAK-3 PROV) by name.

Thus, three above-mentioned patent applications here add as reference.

Technical field

The present invention generally relates to surgical device and method, and relates more specifically to be used for open wedge operating equipment of (open wedge) osteotomy and method.

Background technology

For the osteotomy of knee is important component part to the surgical operation therapy in the arthritic processing of Patella.The final goal of knee osteotomy be ease the pain symptom, slow down disease progression and in younger patient, postpone whole knee endoprosthesis plasty by the unaffected relatively part of the weight supporting load being transferred to knee.

The knee osteotomy of normal execution is osteotomy or " high tibia " osteotomy of proximal tibia.The first routine tibia osteotomy of report was in 1958.Through nineteen sixties and the seventies, knee osteotomy principle and technology continue development.Yet today, except at the first plastic surgery of minority center, the ordinary populace in the plastic surgeon is critically treated the osteotomy of proximal tibia usually.Whole group realize into, at first, the surgery operating technology of osteotomy is complicated and trouble, many practices that need be in " field " are to carry out and to duplicate the osteotomy process effectively.

More specifically, current techniques needs to need to spread all over process simultaneously and use fluoroscopy continuously by the guide line that manually guides and the resected bone instrument of manual guidance usually.In such process, can't carry out suitably that the degree of accuracy that needs can cause lacking or the back loss of perform the operation is corrected and complication, such as delayed union or disunion, to inner the fracture and nerve and vascular problem in unexpected change, joint on the inclined-plane of tibial plateau.All these problems cause the direct risk to the surgical result of success.In addition, use the postoperative recovery of current techniques may need suitably long period, so that the protection osteotomy avoids possible disunion during long rehabilitation period in period.And the process of current implementation often needs second surgical operation to remove mounting hardware.

The long-term surgical result of the high tibia osteotomy process of report changes quite greatly.Announce to these processes studies show that in the time of back 5 years, about patient of 80% to 90% realizes pain relief and functional rehabilitation usually in operation, and in operation in the time of back 10 years, about patient of 50% to 65% realizes pain relief and functional rehabilitation usually.

Along with the past of time, method and the principle of carrying out osteotomy with surgical operation develop lentamente.Two kinds of common osteotomy methods are: (i) the closed wedge method in the outside; (ii) inside wedge method (with internal fixing device or external fixation device).In these two kinds of common types of surgical method, there is different nuances in the surgery operating technology that discrete plastic surgeon provides.For example, because till today, " optimality criterion " surgery operating technology also do not occur, in discussing, hear that " I so do " is common with discrete surgeon.

The closed wedge method in the outside is for being used for the operating traditional method of osteotomy.This is the modal osteotomy that is used for chamber osteoarthritis between the inboard.Usually realize aligned rectification by the opening that at first removes bone based on the outside angled wedge shape in ground and closed generation subsequently.

In recent years, it is more popular to have an inside wedge method of internal fixation.Usually by at first in the inboard sagittal plane of knee, forming single horizontal bone groove, and manually open otch in the fluoroscopy FAXIA with a series of osteotome or the wedge shape osteotome that pre-determines size subsequently and realize aligned rectification.The RA of the ability of operation needing more easily to realize when this technology is generally the surgeon and provides surgical operation to carry out.Little fixing head and bone screw with the opening of supports wedge osteotomy is fixed on given height with open wedge subsequently.Fill the space of the bone of opening subsequently with bone graft material.

Inside wedge method by external fixation device be most commonly used to need big rectification in case realize suitable on time.Aligned rectification realizes by at first form single bone groove in the inboard sagittal plane of knee.Next, apply external fixation device and subsequently usually based on regulating regularly with little increment every day, so that lentamente wedge shape is opened to the RA of requirement.Usually confirm the progress of this surgery surgical technic weekly with actinogram.

Open wedge technique as can by more easily be learned to be provided for simultaneously with to around the minimum risk of nerve and blood vessel structure realize that faster, the simpler surgical procedures of better method of the RA of requirement is advocated.Yet, allow wide window for the introducing of surgical operation mistake as the different open wedge surgery operating technology of current implementation.

Place front-tibia inclined-plane, back that directing pin are called AP tibia inclined-plane when being limited with as whole these open wedge osteotomy Technology Need manual guidance ground of current implementation, and need to use hand-held and osteotome manual guidance, these all use in the fluoroscopy FAXIA.Must use of the adjusting of fluoroscopy image continually to determine to work during the course and to carry out that position and needing will in remaining process, carry out.The mistake of surgeon in limiting AP tibia inclined-plane can cause having the osteotomy of placing inadequately to the unexpected change on tibia inclined-plane, and this can influence knee stability again.Mistake when forming bone groove in the saw blade of the osteotome of use manual actuation or manual guidance can cause the tibia inclined-plane to change, osteotomy moves to intraarticular and/or injury nerve and vascular system and soft tissue structure.

Recently the development of the improvement in osteotomy has concentrated on two general parts.One of them comprises the improved wedge shape osteotome of the cuneiform osteotomy that is used to form or opens bone.Another is used for keeping rigidly open wedge during being included in zero gravity supporting recovery phase, and is used to increase the low profile internal fixation plate to the support at whole osteotomy position during the weight supporting recovery phase.Though it is very important, but these progress do not solve following important problem, include but not limited to that the minimizing of surgical operation study curve is so that process is more reproducible, the minimizing of the use of the improvement of the surgical operation degree of accuracy of osteotomy process, fluoroscopy and the internal fixing device that the is used for open wedge osteotomy fact of stress shielding osteotomy or fracture site effectively.Such stress shielding often is the factor that comprises disunion and correct the complication of loss.

Today, the needs of demand plastic surgeon before adopting new surgical procedures.Actual demand is included in determines the Deuteronomic knee osteotomy process of RA before the operation and exactly in the degree of accuracy of carrying out surgery operating technology with reproducible result.Final surgical result depends on that the surgeon accurately carries out RA and guarantees to correct the ability of keeping enduringly.

The example of the defective of prior art

In current surgical operation practice, if the surgeon wishes the AP inclined-plane is carried out the change (from the change of the plan of preoperative x ray or the change that needs of the bone groove when surgical operation carries out during the knee osteotomy of routine) of requirement, the surgeon faces different selections to help to readjust the bone inclined-plane.

The first, the surgeon can be placed on the solid slug (that is, allograft bone or synthetic bone) of additional bone graft material or bone graft the specific location in inherent space, osteotomy space, to help to readjust the AP inclined-plane.Yet at the surgery intra-operative, this of " filling out pad " is carried out and often is difficult to estimate and calculate.

The second, and with reference to figure 1, the fixing head 5 that provides specific AP inclined-plane to change as tibia 10 can be provided the surgeon.With the difficulty of this approach is the only fact of the part in supports wedge space 15 directly of fixing head 5.There is possible complication, wherein, even little weight supporting power can act on the inclined-plane of bone and regulate on the inclined-plane of minimum supported regional effect plan.

The 3rd, the surgeon can (i) be placed on specific location in the inherent space, osteotomy space with solid determine (that is, allograft bone or synthetic bone) of bone graft, with help readjust the AP inclined-plane and, (ii) utilize fixing head 5 in addition.Equally, this bonded approach suffers above-mentioned pad and the fixing head problem of filling out.

Also there is other problem in the selection of determining above three.First, though can before operation, determine the definite measurement that the AP inclined-plane changes, because need fill out the skew cutting planes and the fixing head that may reappraise the inclination of hope of pad subsequently, the adjusting the when execution of the change of plan is still carried out with surgical operation is usually carried out.The second, even surgical purpose is not to influence AP tibia inclined-plane, the present practice of knee osteotomy always guarantees that almost it will be affected in a way.For the approach of front-inboard, this is because the opening in skew cutting planes and osteotomy space.The surgeon must be subsequently carries out the adjusting of surgical operation when carrying out with the fixing head of filling out pad and tilt, carries out that vision ground is estimated and the not predetermined change of radiophotography device before the high-grade operation.The 3rd, the inaccurate of adjusting of carrying out the AP inclined-plane can cause the later direct bad result of surgical operation, perhaps influences the corrigent last loss of long-term results nocuously.

Goal of the invention

Therefore, one object of the present invention is for providing the improved open wedge osteotomy system of apparatus guiding and modular mode.

Another object of the present invention is the total surgeon's learning curve that reduces in carrying out the open wedge osteotomy process.

Another object of the present invention is for providing the improved open wedge osteotomy system that allows the reproducible process of surgical operation more and reduce the surgical operation mistake.

The improved open wedge osteotomy system of a further object of the present invention for providing the permission process to be carried out quickly.

Another object of the present invention is for providing the improved open wedge osteotomy system that reduces or eliminates during process the needs of fluoroscopy.

A further object of the present invention limits front-tibia inclined-plane, back and makes it possible to the improved open wedge osteotomy system of the front-back joint line of labelling nature under the situation of not using the radiophotography imaging for providing by visual inspection.

A further object of the present invention is for providing the improved open wedge osteotomy system of carrying out preoperative measurement exactly.

A further object of the present invention is for providing improved open wedge osteotomy system, wherein, be attached to the location and the fixation mark natural joint line of the guiding device on it by bone groove guide system, provide cross sections reliably according to doctor's preoperative calculating thus by bone.

A further object of the present invention is for providing the improved open wedge osteotomy system that limits exactly with respect to the cutting planes on AP tibia inclined-plane.

A further object of the present invention is for providing the rear side kept from the bone improved open wedge osteotomy system by sagittal constant angled cutting planes to the front side of bone and during resected bone.

A further object of the present invention is opened the osteotomy space to the angle that requires exactly for providing, the improved open wedge osteotomy system of the risk on the AP of reduction change simultaneously tibia inclined-plane and the risk of fracture.

Another object of the present invention is for providing the improved open wedge osteotomy system that reduces or eliminate the use of static internal fixation plate and screw.

The improved open wedge osteotomy system that another object of the present invention is grown for the physiology that provides promotion better to cross the bone at osteotomy position.

Another object of the present invention is for providing a plurality of part implant systems, and the periphery in this implant system fringing osteotomy space allows to comprise different bone graft material in the bone section of supporting heavy orientation.

A further object of the present invention be provided for by the surgeon customize at the scene assembling a plurality of part implant systems.

A further object of the present invention is the method that is provided for forming osteotomy, wherein, part ground is introduced a plurality of part implants in the osteotomy space one by one, so that promote the process that infringement is minimum, and wherein, implant member is assembled at the scene by the surgeon subsequently.

A further object of the present invention is for providing a plurality of part implant systems that allow graft material optimally to be compressed or insert in the osteotomy space and comprise by a plurality of part implant systems.

A further object of the present invention is for providing a plurality of part implant systems, wherein, the implant member of different size is assembled into together so that can accurately regulate AP tibia inclined-plane.

A further object of the present invention is a plurality of part implant systems on inclined-plane that the requirement of tibial plateau being kept and be supported on from its front side its rear side exactly is provided.

A further object of the present invention is for providing a plurality of part implant systems, wherein, implant member is propped up the periphery of support bone, and screw or attachment means by implant member and enter surrounding bone subsequently by a plurality of part implants are fixing in position.

A further object of the present invention wherein, is led to passage interface between implant and host bone on surface for a plurality of part implant systems are provided, and promotes directed osseocolla, cement, biomaterial or the graft materials of injecting thus.

A further object of the present invention is for providing a plurality of part implant systems, and wherein, two implant member comprise different biomaterials, biological composite or its prescription, so that allow the optionally resorbent different rates of implant member.

A further object of the present invention is for providing osteotomy system, and wherein, the orientation direction device is positioned on the skin top and via skin and is fixed to tibia, so that provide infringement minimum osteotomy.

Summary of the invention

Consider above-mentioned and other purpose, in a kind of form of the present invention, provide the osteotomy implant that is used to support open wedge osteotomy, this osteotomy implant comprises:

Be used to be arranged in first parts in the part of back of open wedge osteotomy;

Be used to be arranged in second parts in the part of front of open wedge osteotomy;

Be used for selectively first parts and second parts are connected to each other connecting device.

In another kind of form of the present invention, the osteotomy implant of a plurality of parts that are used to support open wedge osteotomy is provided, this osteotomy implant comprises:

Be used to be arranged in the 3rd parts in the part of inboard of open wedge osteotomy;

Be used for selectively first parts being connected to first bindiny mechanism of the 3rd parts; And

Be used for selectively second parts being connected to second bindiny mechanism of the 3rd parts.

In another kind of form of the present invention, the orientation direction device that is used in tibia carrying out open wedge osteotomy is provided, this orientation direction device comprise the joint line of the part that is used to aim at the orientation direction device and tibia aligning parts, be used for that the orientation direction device is fixed to the fixed part of tibia and be used for the orientation direction device is connected to the link of cutting guide.

In another kind of form of the present invention, the cutting guide that is used for carrying out open wedge osteotomy in tibia is provided, this cutting guide has the guide attachment parts that are used for selectively cutting guide being attached to tibia, and cutting guide forms therein and is configured to guide cutter to enter tibia so that form the angled cutting groove of bone groove in tibia.

In another kind of form of the present invention; the protector member of the front that is used to carry out open wedge osteotomy and the protector member of back are provided; in the protector member of front and the protector member of back each has first end; the second end and between first end and the second end, have given length; each has the connector part that is configured to anchor to tibia the first end of the protector member of front and the protector member of back; each has the shape of fixed wheel exterior feature closely to be similar to the front side and the rear side of tibia respectively the protector member of front and the protector member of back; wherein; each inserts the second end of the second end of the protector member of front and the protector member of back towards front side and rear side respectively from the inboard around tibia, and the first end of the protector member of the first end of the protector member of front and back each anchor to tibia.

In another kind of form of the present invention, the mechanic jacks that is used for carrying out open wedge osteotomy in tibia is provided, this mechanic jacks comprises the jack attachment parts that are used for selectively jack being attached to tibia, this mechanic jacks has a pair of plate with reciprocal first end and the second end, this first end to plate be configured to roughly keep with each other together and be configured to be placed in the bone groove in the tibia, and this second end to plate be configured to selectively to locate (i) from this to the second end of plate roughly with together primary importance each other, (ii) arrive this second end second position away from each other, so that diverge to tibia at the bone groove place to plate.

In another kind of form of the present invention, the system that is used for carrying out open wedge osteotomy in tibia is provided, this system comprises:

Have the part that is used to aim at the orientation direction device and tibia joint line aligning parts and be used for the orientation direction device is fixed to the orientation direction device of the fixed part of tibia;

Cutting guide with the guide attachment parts that are used for selectively cutting guide being attached to the orientation direction device, this cutting guide form therein and are configured to guide cutter to enter tibia so that form the angled cutting groove of bone groove in tibia;

Mechanic jacks with the jack attachment parts that are used for selectively jack being attached to the orientation direction device, this mechanic jacks has a pair of plate with reciprocal first end and the second end, this first end to plate be configured to roughly keep with each other together and be configured to be placed in the bone groove in the tibia, and this second end to plate be configured to selectively to locate (i) from this to the second end of plate roughly with together primary importance each other, (ii) arrive this second end second position away from each other, so that diverge to tibia at the bone groove place to plate; And

Be used in tibia supporting a plurality of part implants of open wedge osteotomy, these a plurality of part implants have first parts in the part of the back that is used to be arranged in open wedge osteotomy, be used to be arranged in second parts in the part of front of open wedge osteotomy and be used for selectively first parts and second parts are connected to each other connecting device.

In another kind of form of the present invention, the method that is used for carrying out open wedge osteotomy in tibia is provided, this method comprises:

Be provided for carrying out in tibia the system of open wedge osteotomy, this system comprises:

Have the part that is used to aim at the orientation direction device and tibia joint line aligning parts and be used for orientation direction device main body is fixed to the orientation direction device of the fixed part of tibia;

Mechanic jacks with the jack attachment parts that are used for selectively jack being attached to the orientation direction device, this mechanic jacks has a pair of plate with reciprocal first end and the second end, this first end to plate be configured to roughly keep with each other together and be configured to be placed in the bone groove in the tibia, and this second end to plate be configured to selectively to locate (i) from this to the second end of plate roughly with together primary importance each other, to (ii) this to the second end second position away from each other of plate, so that diverge to tibia at the bone groove place; And

Be used in tibia supporting a plurality of part implants of open wedge osteotomy, these a plurality of part implants have first parts in the part of the back that is used to be arranged in open wedge osteotomy, be used to be arranged in second parts in the part of front of open wedge osteotomy and be used for selectively first parts and second parts are connected to each other connecting device;

Use aligning parts to aim at the joint line of orientation direction device and tibia;

Use fixed part that the orientation direction device is fixed to tibia;

The guide of cutting guide attachment parts are attached to the orientation direction device, so that angled cutting groove is positioned at predetermined orientation with respect to the joint line of tibia;

The angled cutting groove of motion cutter by cutting guide is so that form bone groove in tibia;

This first end to plate of mechanic jacks is positioned in the bone groove, this to the second end of plate at this to the second end of plate roughly in together the primary importance;

Start mechanic jacks so that this second end to plate is moved to this second end second position away from each other to plate from primary importance, so that diverge to tibia at the bone groove place; And

A plurality of part implants are inserted tibia.

Cutting guide with the guide attachment parts that are used for selectively cutting guide being attached to tibia, this cutting guide form therein and are configured to guide cutter to enter tibia so that form the angled cutting groove of bone groove in tibia;

Has a pair of mechanic jacks with plate of reciprocal first end and the second end, this first end to plate be configured to roughly keep with each other together and be configured to be placed in the bone groove in the tibia, and this second end to plate be configured to selectively to locate (i) from this to the second end of plate roughly with together primary importance each other, to (ii) this to the second end second position away from each other of plate, so that diverge to tibia at the bone groove place; And

Has a pair of mechanic jacks with plate of reciprocal first end and the second end, this first end to plate be configured to roughly keep with each other together and be configured to be placed in the bone groove in the tibia, and this second end to plate be configured to selectively to locate from (i) this to the second end of plate roughly with together primary importance each other, to (ii) this to the second end second position away from each other of plate, so that diverge to tibia at the bone groove place; And

Aim at the joint line of cutting guide and tibia;

Cutting guide is attached to tibia, so that angled cutting groove is positioned at predetermined orientation with respect to the joint line of tibia;

The location angled cutting groove of cutter by cutting guide is so that form bone groove in tibia;

A plurality of part implants are inserted tibia.

In another kind of form of the present invention, the osteotomy implant that is used to support open wedge osteotomy is provided, this osteotomy implant comprises:

Leading edge with first height, first width, and first height construction is to be used to be placed in the part in distally of open wedge osteotomy;

The base part opposite with leading edge, base part have second height, second width, and second height construction is the end of the nearside of closed open wedge osteotomy roughly; And

Leading edge is connected to two opposite sidewalls of base part, opposite sidewall has and equidistant first length from the leading edge to the base part, and opposite sidewall has the height from first height of leading edge to the second height convergent of base part.

Base part with the width between first height, first end and the second end, first end and the second end, first height construction are the end of the nearside of closed open wedge osteotomy roughly;

Two opposite sidewalls that extend from first end and the second end respectively, two opposite sidewalls have the 3rd end and the 4th end, extend from base part the 3rd end, second highly equals first height in the base part at place, the 3rd end, in two opposite sidewalls at place, the 4th end each has the 3rd height, the 3rd height is less than second height, so that allow each the 4th end in two opposite sidewalls is placed in the part in distally of open wedge osteotomy.

In another kind of form of the present invention, the osteotomy implant that is used to support open wedge osteotomy is provided, this osteotomy wedge shape implant comprises:

Two opposite sidewalls with reciprocal first end and the second end, the pair of frames member that extends between the first end of each in two opposite sidewalls and the second end, be arranged in each this in two opposite sidewalls to the extendible material between the framing component, this is connected to each other at its first end to framing component, and this can selectively be separated from each other to the height of selection at its second end to framing component;

Basal component with given height and given width, wherein, given height is substantially equal to each this height to the selection of framing component in two opposite sidewalls, and the distance when wherein, given width is substantially equal in being placed on open wedge osteotomy between two opposite sidewalls; And

Be used for basal component is connected to each one group of adapter of two opposite sidewalls.

Be configured to be arranged in first parts in the part of back of open wedge osteotomy; And

Be configured to be arranged in second parts in the part of front of open wedge osteotomy;

Wherein, in the time of in being disposed in open wedge osteotomy, first parts and second parts form the U-shaped wall.

Be configured to be arranged in the U-shaped wall in the open wedge osteotomy, be formed on the interior section on the concave side of wall and be formed on exterior section on the protrusion side of wall; And

The U-shaped wall forms and enters the visit mouth of interior section from exterior section by it, and wherein, visit allows material externally partly and between the interior section to pass through.

Wherein, first parts comprise first material, and second parts comprise second material, and first material and second material differ from one another.

In another kind of form of the present invention, a plurality of part implants that are used to support open wedge osteotomy are provided, this osteotomy comprises:

Be configured to be arranged in first parts in the part of back of open wedge osteotomy;

Be configured to be arranged in the 3rd parts in the part of inboard of open wedge osteotomy; And

Wherein, first parts comprise first material, second parts comprise second material, the 3rd parts comprise the 3rd material, and from the group of forming by first material, second material and the 3rd material, select a kind of with from the group of forming by first material, second material and the 3rd material, select another kind of different.

More specifically describe and in claims, point out above-mentioned and further feature of the present invention referring now to accompanying drawing, comprise the various new details of structure and the combination of part and method step.Should be appreciated that and embody that concrete apparatus and method step of the present invention only illustrates as an example and be not as limitation of the present invention.Principle of the present invention can be utilized in many different embodiment under the situation that does not depart from scope of the present invention with feature.

Description of drawings

Next these and other objects of the present invention and feature will be by more fully being disclosed the detailed description of preferred embodiment of the present invention or being become obvious, these preferred embodiments will be considered together with accompanying drawing, similar in the accompanying drawings numeral refers to similar part, and wherein:

Fig. 1 is the sketch map of the osteotomy system of the hone lamella of use prior art;

Fig. 2-5 is the sketch map of the new orientation direction device 20 of parts of the preferred embodiment of the new osteotomy system of explanation;

Fig. 6-12 is the sketch map of the new cutting guide 45 of another parts of the preferred embodiment of the new osteotomy system of explanation;

Figure 13-16 and 16A are the sketch map of the new mechanic jacks 90 of another parts of the preferred embodiment of the new osteotomy system of explanation;

Figure 17-27 is the sketch map of new a plurality of part implants 125 of parts of the preferred embodiment of the new osteotomy system of explanation;

Figure 28-31 is the sketch map that is used for the medial-lateral approach of osteotomy process;

Figure 32-34 is the sketch map that is used for the front-inboard approach of osteotomy process;

Figure 35-37 is the sketch map of the corrigent aligned method determining to carry out to tibia-astragalus (talar) joint mechanical axis patient's femoral head;

Figure 38-47 is the sketch map of the alternate mechanic jacks 300 of the alternate parts of the preferred embodiment of the new osteotomy system of explanation;

Figure 48-89 is the sketch map of explanation for the alternate new implant 500 of the alternate embodiment of the new a plurality of part implants shown in Figure 17-27;

Figure 90-110 for explanation for the new orientation direction device shown in Fig. 2-5 with for the sketch map of the new excision system 700 that comprises two cutter orientation direction devices and excision guide of the alternate embodiment of the new cutting guide system shown in Fig. 6-12; And

Figure 11-130 is the sketch map of explanation for the new extendible wedge shape implant 805 of the alternate embodiment of the new a plurality of part implants 125 shown in Figure 17-27.

The specific embodiment

Summary

The present invention includes the surgical device and the method that are used to carry out open wedge osteotomy.In a preferred embodiment of the present invention, system embody be provided for accurate resected bone, to the accurate control of in bone, opening the osteotomy space, for the accurate realization of the corrigent angle of open wedge osteotomy and be provided for several new apparatus and method of keeping accurately of the open wedge osteotomy of hold bone graft or packing material.The invention provides the system of the apparatus guiding of approach with the infringement minimum that is used to carry out the open wedge osteotomy process.In addition, the invention provides the implant fixed system that promotes that new bone growth and firm bone are repaired.

In a kind of preferred form of the present invention, surgical system comprises four critical pieces: (i) be used to the orientation direction device 20 (Fig. 2) of the system that sets up with respect to the orientation of patient's tibia; (ii) be used to guide cutting guide 45 (Fig. 7) by the osteotomy otch of bone; (iii) be used in bone, opening the mechanic jacks 90 (Figure 15) in osteotomy space; Reach a plurality of part implants 125 (Figure 20) that (iv) are used between the bone convalescence, supporting open wedge osteotomy.

According to the present invention, the at first definite suitable bone groove that will in tibia, form of surgeon.In case the surgeon has determined the suitable attribute of bone groove, the surgeon uses method and apparatus of the present invention to realize resected bone subsequently.

More specifically, the surgeon is preferably:

(i) orientation direction device 20 is attached to position suitable on patient's the tibia;

(ii) select to be attached to the suitable cutting guide 45 of orientation direction device 20, limit the target inclined-plane (or plane) of the otch that will in tibia, form thus;

(iii) select to be attached to the suitable protector member 70,75 of cutting guide 45, protect tibia soft tissue and nerve and blood vessel structure on every side thus;

(iv) cutting guide 45 is fixed to orientation direction device 20, and subsequently protector member 70,75 is fixed to cutting guide 45;

(v) select the suitable cutter 65 that to use during the course, limit the proper depth of the otch that will in tibia, form thus;

(vi) make cutter 65 by being formed on the guiding tank 50 in the cutting guide 45 and passing through tibia 10, follow the path 65A that sets up by cutting guide 45, reached proper depth up to otch;

(the cutter 65 of vii) withdrawing;

(otch that viii) uses mechanic jacks 90 to open in the bone arrives suitable angle; And

(ix) a plurality of part implants 125 are inserted the osteotomy space 110 that is formed in the bone, thus cut tibia is remained on suitable structure.

Preferably, with the inside in the osteotomy space in a plurality of part implants 125 of bone cement or bone paste or the like insertion, promote the firm osteanagenesis length and/or the inside growth of bone thus; And preferably bone cement is injected implant/bone interface to help further a plurality of part implants to be fixed to bone.

Importantly,, use front-inboard approach easily and reliably to form bone groove, provide simultaneously soft tissue around the tibia and fabulous protection neural and blood vessel structure by the present invention.In addition, provide stability about the osteotomy position to allow the implant device realization osteotomy stability that bone graft material and the bone of nature directly contact in open wedge osteotomy simultaneously by use.Importantly, the present invention allows also to promote that new tissue and osteogenesis pass through the physiological compression and the stimulation of needed necessity in space of bone.This differs widely with using fixing head and screw to keep and compare with the open wedge osteotomy system of the prior art that supports corrigent open wedge; Such system does not allow favourable physiological compression force on bone/graft interface.This can cause the osteotomy of disunion and the rectification of failure.

Orientation direction device 20

Next 2-5 with the aid of pictures in preferred embodiment of the present invention, provides to be configured to aim at and fixing in position orientation direction device 20 along the joint line (Fig. 3) of tibia 10.Particularly, the top of orientation direction device 20 and tibial plateau (that is, AP tibia inclined-plane) are aimed at, as shown in Figure 4.Orientation direction device 20 preferably includes a pair of hold-down screw path 25 and threaded attachment boring 30.

With reference now to Fig. 3-5,, shows and a pair ofly extend through orientation direction device 20 and enter tibia 10 so that after the top alignment of the top of orientation direction device 20 and tibia 10, orientation direction device 20 is fixed to the hold-down screw 35 of tibia 10.Attachment screw 40 (Figure 4 and 5) is preferably provided as and is used for various devices are removably attached to orientation direction device 20.Attachment screw 40 preferably includes threaded that is configured to engage with threaded attachment boring 30.

Cutting guide 45

Next 6-12 with the aid of pictures shows the cutting guide 45 that is configured to be attached to orientation direction device 20.Cutting guide 45 preferably is fixed to orientation direction device 20 with attachment screw 40.As shown in Figure 7, cutting guide groove 50 provides the fixed angle that can carry out controlled resected bone.

More specifically, and with reference now to Fig. 8 and 9, cutting guide 45 comprises and receives attachment screw 40 (Fig. 7) so that cutting guide 45 is installed to the through hole 55 of orientation direction device 20, thus with respect to the angled cutting groove 50 in orientation direction device 20 (and therefore with respect to AP tibia inclined-plane) location.Preferably, sectional fixture 60 (Fig. 8) is provided at the sidepiece office of cutting guide 45, is used for protector member 70,75 (below seeing) is installed to cutting guide 45.Cutter 65 (Fig. 9) selectively are inserted through guiding tank 50, make cutter 65 to cut along path 65A with predetermined angle with respect to cutting guide 45 (and therefore, with respect to AP tibia inclined-plane).

With reference to figure 10-12, cutting guide 45 preferably includes protector member 70,75 with protection soft tissue and nerve and blood vessel structure during the bone cutting.Protector member 70,75 (i) inserts patient by little inner surface otch; (ii) the preceding and rear surface of close tibia 10 is below skin histology; And (iii) use sectional fixture 60 to be fixed to cutting guide 45 (referring to Figure 11 and 12).Protector member 70 fixed wheel especially is wide for being used for the front side (Figure 11) of tibia 10, and protector member 75 fixed wheel is wide for being used for the rear side (Figure 12) of tibia 10 especially.Each protector member 70,75 can be for radiolucent, make the radiophotography labelling extend its middle part section length with for example the resected bone stage begins before in the direction of fluoroscopy FAXIA demonstration bone groove.

Figure 11 and 12 shows by the cutting groove 50 (Fig. 9) in the cutting guide 45 and enters the cutter 65 of tibia 10.When cutter 65 cut bone by cutting groove 50 and along the angle of wishing, protector member 70,75 guaranteed that cutter 65 by mistake do not cut soft tissue and nerve and the blood vessel structure in the bone front and back.

Mechanic jacks 90

Next with reference to figure 13-16 and 16A,, can remove cutting guide 45 and protector member 70,75 in case form bone groove.Subsequently mechanic jacks device 90 (Figure 13) is fixed to orientation direction device 20.More specifically, with the bone groove in (mechanic jacks 90) two metallic plates 95,100 insertion tibias 10, and subsequently mechanic jacks 90 is fixed to orientation direction device 20.Can use mechanic jacks 90 that metallic plate 95,100 is relative to each other opened subsequently, so that in tibia 10, form the osteotomy space of wishing.

Alternatively, and see Figure 14 now, be fixed to orientation direction device 20 and operation with when opening the bone groove tibia 10 in mechanic jacks 90, protector member 70,75 can be stayed the interior suitable position of cutting mouth.

By opening mechanic jacks 90 with screwdriver or other apparatus (not shown) rotation worm gear end 115.Referring to Figure 15,16 and 16A.Preferably go up the scale (not shown) of arranging and indicate opening of space 110 or angle (or height) at pillar 120 (Figure 15).

In case the osteotomy wedge shape has been opened to the position of hope, (i) remove whole mechanic jacks 90 or (ii) only remove the part 105 of the front of mechanic jacks 90, cutter 95,100 is stayed in the bone and is opened osteotomy space 110 in the tibia 10 so that remain on.

A plurality of part implants 125

In case used mechanic jacks 90 in tibia 10, to open osteotomy space 110, in the space, disposed a plurality of part implants 125 so that between convalescence, bone is supported on the position of hope.

More specifically, and present 17-27 with the aid of pictures, show a plurality of part implants 125 that can be used to stay open osteotomy space 110.Preferably, a plurality of part implants 125 comprise the part 135 and the inboard or substrate part 140 (referring to Figure 17-20) of part 130, the back of front.The part 130 of front, the part 135 of back and substrate part 140 preferably are assembled at the scene together to form complete a plurality of part implants 125.More specifically, slotted joint 145 (being formed by first 150 and the second portion 155 on each end of substrate part 50 in the part 135 of in front part 130 and back each) is used for the part 130 of front and the part 135 of back are connected to substrate part 140.Though joint 145 is depicted as the female element on the part 135 of the male element that is included on the substrate part 140 and part in front 130 and back in the drawings, this is provided with and can maybe can uses alternate joint or adapter conversely.Implant 125 is preferably disposed (i) by following steps and at first the part 130 of front, the part 135 and the substrate part 140 of back is positioned in the space respectively in osteotomy space 110, and (ii) subsequently the part 135 and the substrate part 140 of the part 130 of front, back combined (using slotted joint 145).

One group of fixing hole 160 (Figure 23) is provided in the substrate part 140 to use hold-down screw 175 (Figure 26) that the implant 125 that assembles is fixed to tibia.Substrate fixing hole 160 preferably is arranged as relative to each other angled, so that guide at least one hold-down screw 175 to enter tibia 10 on every side in space 110.More specifically, in the bone surface in the space 110 of the bone interface surface 140A (Figure 23) of substrate part 140 joint formation tibia 10.Fixing hole outlet 160A forms by surperficial 140A so that the tibia 10 around permission hold-down screw 175 (Figure 26) feeding.Hold-down screw 175 enters tibia 10, thus substrate 140 (and so whole implant 125) is fixed to tibia 10.

The part 130 of the front of implant 125 and the part 135 of back preferably include the inlet 165 (Figure 22) that leads to passage 170.Passage 170 extends through on the upper and lower surface of part 135 of the part 135 of the part 130 of front and back and part in front 130 and back and leaves, and is communicated with part/bone interface thus.Inlet 165 allows material (for example, bone cement, bone paste, growth reinforcing agent or the like) to be transported to part/bone interface.

The part 130 of front, the part 135 of back and/or substrate part 140 can be formed by resorbent material by one or more, and they can be absorbed in the host bone more thus.

In a kind of preferred form of the present invention, the part 130 of front, the part 135 of back and substrate part 140 are all formed by the biomaterial and/or the biological composite that absorb in the host bone again, and the part 130 of front and the part 135 of back form and make them absorb sooner again than substrate part 140.By forming substrate part 140 by more competent biomaterial and/or biological composite, substrate part 140 can provide persistent intensity and support to guarantee the osteogenesis of the optimum in the space 110 for osteotomy.

Preferably, during process, zone in the osteotomy space 110 is filled with bone cement, bone paste, growth reinforcing agent or the like, and making will be along with the past formation bone of time or the inside growth of bone by the osteotomy space 110 of a plurality of part implant 125 restrictions.This can (i) in front part 130 and after the part 135 of back disposed in the osteotomy space, and (ii) realization substrate part 140 is fixed to

part

130 and 135 before.Alternatively, additional through hole (not shown) can extend through substrate part 140, even allow still can visit the inside in osteotomy space 110 thus after a plurality of part implants have been assembled in the osteotomy space.

The osteotomy process

Can use medial-lateral approach or front-inboard approach to carry out the osteotomy process.

(i) medial-lateral approach

Next 28-31 with the aid of pictures shows the medial-lateral approach of the osteotomy otch with certain depth.

With prior art system and method, use the medial-lateral approach can allow the correct AP tibia inclined-plane of the easier acquisition of surgeon, this is vital for knee stability.In addition, with prior art system and method, the medial-lateral approach can allow the surgeon to control from behind the cutting planes of front more easily.

Yet in practice, owing to there is the soft tissue structure of being attached the position such as medial collateral ligament, it may be difficult carrying out the medial-lateral approach with prior art system and method.Therefore, with prior art system and method, can preferably use front-inboard approach.

(ii) front-inboard approach

Next with reference to figure 32-34, with prior art system and method, front-inboard approach may have difficulties keeping on the controlled cutting planes.With prior art system and method, can not guarantee usually with respect to sagittal plane with the cutting planes of fixed angle offset so that keep tibia inclined-plane, existing front-back (AP).Basically, by prior art system and method, when cutting bone, regulate the actual cutting planes of formation by sagittal plane being carried out two or more angles in the mode that tilts with manual guidance and guide.In case open osteotomy and form the osteotomy space, this biasing and angle of inclination make and are difficult to keep patient's anatomy tibia inclined-plane.

If do not keep or control anatomy AP inclined-plane, patient may experience postoperative knee instability.In addition, some surgeon begun by the AP tibia inclined-plane to patient carry out planned adjusting solve the knee instability problem (since knee thread be with loose or knee thread be with impaired).Important planned change to the inclined-plane like this must accurately and methodically be carried out.

When carrying out open wedge osteotomy, and more specifically when the high tibia osteotomy of execution, in order to realize positive surgical result, the surgeon need carry out many important elements.

An important element is for keeping tibia inclined-plane, front-back (AP).

Another important element is to keep and control the plane that wherein forms bone groove.

Another important element is for providing the regenerated fixed system that promotes physiological rehabilitation and new bone so that be provided for competent osteotomy.

Another important element between convalescence, supporting the osteotomy space so that keep AP tibia inclined-plane and protection is used to the bone grafting material that makes that new bone can be grown.

In the prior art system and the method that are used for carrying out front-inboard approach, be not easy to satisfy above-mentioned condition usually.Thereby the approach that the common teaching of the document of announcement is used to form the best of bone groove is direct medial-lateral approach.

Importantly, the invention provides the improved system and method for the open wedge osteotomy that is used to use front-inboard approach.

(iii) preferable methods

Next with reference to Figure 31, show and in many medical literatures, be discussed as the medial-lateral approach that in sagittal plane, forms " the best " approach of bone groove as mentioned above.Yet in practice, because the attachment of medial collateral ligament, this may be the process of difficulty.

See Figure 33 now, the present invention preferably uses front-inboard approach, make by using orientation direction device 20 and cutting guide 45 to set up the position of bone groove, as discuss above and as argumentation in further detail hereinafter.

With reference now to Figure 35-37,, there is the technology of many announcements, by the technology of these announcements, the surgeon can determine and will aim at by the accurate rectification that the osteotomy of carrying out is set up.Whole normally used technology need overall length standard A P and outside actinogram usually.Usually, from the center of femoral head 205 to the center setting-out 200 (Figure 35) in tibia-astragalus joint 210.This expression patient's current mechanical axis.62.5% point 220 of the width from the center of femoral head 205 to the tibia that is positioned at the nearside in the knee endoprosthesis of the outside is drawn another lines 215.Draw the 3rd line 225 from the center in tibia-astragalus joint 210 to the same point 220 in the knee endoprosthesis of the outside.The angles 230 that intersect to form by two lines 215 and 225 determine to make patient's mechanical axis to return the needed corrigent angle in cross point on the side in the outside.

Next, the surgeon must determine the depth of cut and suitably definite size, the slotted cutting guide 45 that will be used for process of osteotomy.

With reference now to Figure 36,, on actinogram, the surgeon is the outside cortex setting-out 235 from the part 240 of the inboard cortex of tibia to joint line below 1 centimeters at first.Next, setting-out subsequently 250, its (i) is perpendicular to line 235 and (ii) be equal to or greater than 1 centimetre apart from the outside cortex 245 of tibia 10.The proper depth that point 255 labellings that line 235 and line 250 intersect will pass the bone groove of tibia 10 formation.Measurement from inboard cortex 240 to the cross point 255 distance 260.Distance 260 is the ultimate range (or degree of depth) of the bone groove that will carry out.

Next, the surgeon calculates the inlet point that is used for the osteotomy bone groove.But 255 have angle downwards remain on tibial tubercle 270 tops of front from the cross point, point 275 setting-outs 265 on the vertical line that the part 240 of the inboard cortex of mentioning to the face in the past of being positioned at descends.The initial inlet point 280 (Figure 37) that is used to carry out excision is positioned at line 265, and can calculate according to point 240 and the distance of putting between 275 285.

From passing through an excision angle 290 that the inner wedge angle calculation of 240,255 and 275 (Figure 36) formation tilts.

By so preoperative plan, the surgeon can calculate the location of the needs of the bone groove that will be used to form the osteotomy space, and it will be used to realize RA 230 (Figure 35) again.More specifically, before the beginning osteotomy, the surgeon can calculate: (i) be used for the inlet point 285 on the inboard cortex of bone groove; (ii) Qie Chu the degree of depth 295; And (iii) pass the angle 290 of tibia 10 with the inclination of the bone groove of tibial tubercle 270 tops that remain on the front.

In case the surgeon has determined the suitable attribute of bone groove, the surgeon uses method and apparatus of the present invention to realize resected bone subsequently.More specifically, the surgeon is preferably:

(the cutter 65 of vii) withdrawing;

Preferably, the inside with the osteotomy space in a plurality of part implants 125 of bone cement or bone paste or the like insertion promotes the inside growth of firm osteogenesis and/or bone thus; And preferably bone cement is injected implant/bone interface to help further a plurality of part implants to be fixed to bone.

As mentioned above, bone groove is penetrated in about one centimetre of the side in the outside of tibia usually.In some cases, opening the osteotomy space subsequently can cause bone hinge a long way off to break.Therefore, and see Figure 34 now, wish by the little bone of 70 millimeters long.Plate 305,310 preferably is configured to roughly extend the entire depth of bone groove, and competent support is provided when opening bone with box lunch.Whole two plates 305,310 connect in the end 330 in their distally or are attached to each other and allow the end 335 of their nearside relative to each other to open, and form the wedge shape of opening thus.

Plate 305,310 and provide the machinery 340 (Figure 44) of degree of the consideration of opening of bone groove to connect.Machinery 340 preferably includes rail system 345 and actuation gear 350 (Figure 44).There is the sun that allows plate to be attached to actuator housings 360 to protrude 355 at 335 places, end of the nearside of each plate 305,310.Actuator housings 360 preferably includes the rectangular slab 365 that holds at least one sliding component with hook tooth 375 370.Sliding component 370 preferably includes the scale mark 380 of specific size.Scale mark 380 can adopt various sizes unit, for example comprises, is the angle of unit with the degree or is the opening of unit with the millimeter.Actuator housings 360 is preferably dimensioned to be about 1 centimetre of wide * 2 centimeter length * 3-5 millimeters deep.Actuation gear 350 is rotatably fixed to housing 360, makes tooth 385 engage the tooth 375 on the sliding components 370.Because this structure, when rotation actuation gear 350, it is motion sliding component 370 (direction that depends on rotation) up or down effectively, relative to each other opens thus or closure plate 305,310.Sliding component 370 is preferably dimensioned to be the long 2-4 millimeters thick of about 5 millimeters * wide 2 cm x, and has and intracardiacly in being positioned at protrude 355 Female Connectors that cooperate 390 (Figure 44) with the positive type of following plate 310; Accordingly, housing 360 preferably has the Female Connector 395 that cooperates with the Male Connector 355 of top plate 305.Preferably, also provide stop pin 400, in case inwardly push away stop pin 400, stop pin 400 is coupled in the gear teeth 375 of sliding component 370, prevents sliding component 370 motions thus.

(not shown) in alternate preferred embodiment, circular actuator are configured to drive two sliding components in relative to each other opposite direction, so that relative to each other upwards open or downward closure plate 305,310.

With reference now to Figure 45-47,, shows the operation of mechanic jacks 300.More specifically, the bone groove 405 that forms before plate 305,310 slips into.Preferably use manual driver instrument 410 at the direction rotary actuator device 350 of beginning open plate 305,310 to Wedge-shape structures.When wedge shape was opened, the surgeon noticed the angle (determining) of the hope that the position of the scale mark 380 on the sliding component 370 (Figure 46) and open plate 305,310 are made to bone reconstruct before operation.In case the realization RA, the stop pin 400 that preferably is positioned on the side of actuator housings 360 slips into suitable position so that prevent sliding component 370 motions.After this, can carry out osteotomy in the mode of discussing before, that is, and the opening that the surgeon inserts a plurality of part implants 125 in the bones, stable thus and fixing open wedge osteotomy.

Alternate implant 500

In alternate embodiment of the present invention, and, can use the alternate implant 500 of replacing above-mentioned a plurality of part implants 125 to carry out above-mentioned osteotomy process with reference now to Figure 48-60,61-68,69-74,75-78,79-87 and 88-89.Preferably, alternate implant 500 is utilized the periphery in formation osteotomy space 110 and the design (Figure 48) that conduct is used for supporting with RA 505 pillar of tibias 10.

The same with a plurality of part implant 125, the master-plan of the implant 500 of replacing is wedge shape (Figure 49), have preceding (or distally) edge 510 in (or distally) part of the closure that is coupled to open wedge osteotomy and be coupled to substrate in the opening (or side of nearside) of open wedge osteotomy (or nearside) side 515.Implant 500 comprises two opposite sidewalls 520 (Figure 50), and each is preferably dimensioned to be about 2-5 mm wide, and their surface constitutes the periphery in the space of bone, has open interior periphery 525, front side or edge 510 and high base side 515.Substrate 515 preferably has about 2-10mm or bigger height.In preferred embodiment of the present invention, substrate 515 has the width wideer slightly than the end 510 in distally, and substrate 515 becomes fillet (Figure 51) at its outer side.The degree of depth of the approximate osteotomy of the length of implant 500, its size is typically about the 40-70 millimeter.Implant 500 is constructed so that integrally, it passes the periphery that tibia 10 is closely followed in osteotomy space 110.

Except those shown in Figure 49-51, implant 500 can be utilized different shape and structure, as will be described below.

Next with reference to Figure 51, in preferred embodiment of the present invention, implant 500 comprises solid wedge shape framework implant 530.Pro-(perhaps distally) end 510 places, the height of implant 500 reduce or convergent with the part of the closure that meets the tibia osteotomy.At substrate (or end of nearside) 515 places, the higher opening of implant with the bigger exposure that meets cuneiform osteotomy.Implant 530 extends to substrate 515 from leading section 510 can have width identical or variation (for example, widening).The substrate 515 of implant 530 preferably includes one or more holes or the opening 535 that fully extends through substrate 515.Opening 535 allows material is introduced implant inside, this material can for, for example, allograft or autograft bone, the bone sub that demineralizes has preferably that bone is induced or other bone graft material of bone conduction character, bone cement, or the material of other hope.Preferably, implant 530 has four successive or bonded sides, comprises substrate 515, two sides 520 and bottom parts 540; These four parts limit opening periphery 525 together.

With reference now to Figure 52-55,, shows monolithic wedge shape framework 545,550,555 and 560 respectively.These four frameworks are formed by three (substrate and two sides) successive or bonded parts, but (that is, the distally) edge before not having, and have the bottom (that is, they have omitted bottom parts 540) of opening.

With reference now to Figure 56-60,, in other preferred embodiment of the present invention, provides the wedge shape framework 565,570 and 575 of a plurality of parts that comprise substrate 515 and two opposite sidewalls 520.In the situation of implant 565, substrate 515 can form two and half ones, and one and half ones are connected to each sidewall 520.In the situation of wedge shape framework 570 (Figure 57) and 575 (Figure 58), substrate 515 can comprise two and half ones, and one is connected to each sidewall 530, and connecting plate connects together two substrate half ones.Forming framework 565,570 and 575 various parts preferably inserts osteotomy space 110 respectively and is fixed together in the situation that comprises the wedge shape framework 570 that is connected basal component and 575.Preferably, at first insert the side of back, insert the side of front subsequently, and in framework 570 and 575 situation, insert at last and be connected substrate.Substrate 515 preferably uses preferably identical with the material of implant screw, bar or any other fastening device to be attached to side 520 at 580 places.

A plurality of part implants 565,570 and/or 575 and the advantage of the uniqueness of a plurality of part implants 125 of describing before for the wall 520 by inserting a certain height and size and insert the opposite wall 520 that may have differing heights and size subsequently and realize ability to the change of the expection on tibia inclined-plane.These changes can be calculated before operation or can are by surgeon's results estimated when surgical operation carries out.

Next 61-68 with the aid of pictures, any aforementioned implant 500 and aforementioned a plurality of part implant 125 can comprise protrusion, protuberance or outstanding 585 (jointly being called " protruding 585 " hereinafter sometimes here) on its bone interface surface.These protrude 585 and are shaped by this way, to allow easily implant 500 to be inserted osteotomy space 110, in case but after implant 500 cooperates in position, prevent that implant 500 from moving.

Various wedge shape implants 500 can maybe can be absorbed or can not resorbent any other biocompatible material or polymer formation by metal (for example, titanium or rustless steel), and these materials can be or can not be that bone is induced or bone conduction.

Next see Figure 68, can be fixed to tibia 10 further by screw or bar 590 are preferably entered the substrate 515 that tibia 10 places implant 500 by substrate 515 angularly.Can guide screw or bar 590 in the above and below enter tibia.In addition, the substrate 515 of implant can also play fixed system, substitutes traditional immobilized fixing head and bone screw thus.

As mentioned above, substrate 515 can be formed by the metal material that can promote or can not promote the integration of bone, biological absorbable material, biological composite material, perhaps by biological composite material and metal in conjunction with forming so that increase intensity to the final load at osteotomy position.The spontaneous remission that is provided at the osteotomy position provides sufficient weight supporting to support and intensity period, and begin subsequently to absorb again, prevent from thus or reduce to repair and the basal component of the effect of the stress shielding of new bone growth can be preferred along with the past of time.Can resorbent basal component combining with the implant that can resorbently have solid wall like this provides the active compression of passing the osteotomy position, promotes the faster and firmer rehabilitation at osteotomy position thus.

Present 69-74 with the aid of pictures, in another preferred embodiment of the present invention, wedge 500 can be taked various structures, and these structures are in conjunction with extending through parts biocompatible adhesive glue, bone cement, somatomedin or graft materials are transported to the passage 595 of bone contact surface 600.These materials are preferably can be resorbent.It is important feature that passage 595 is provided in implant, because (i) when carrying glue or cement shape material by passage 595, it can allow implant to be fixed in osteotomy space 110, and (ii) when carrying somatomedin or graft materials, it can promote the ingrown formation of favourable bone.

Can not resorbent cement or glue during when adding with fixation implant, allow in the cortical bone grows of nature and the surface that new bone is incorporated into the wedge shape implant and the surface by the wedge shape implant can be favourable; This can provide the firmer rehabilitation at better long-term safety and osteotomy position.Similarly, these binding agents and/or bone cement material can be carried by the combination and the narrow tube 605 (Figure 69) of the passage 595 aligned openings 610 on the surface 600 that reaches implant 500.In case the material 612 of binding agent or cement shape delivers into by pipe unit 605 and arrive the surface of bone of the nature of the surface 600 of implants 500 and tibia 10 by passage 595, withdrawal pipe unit 605.Such transport way provides adhesive area in the surface 600 of the contact implant 500 of the bone that allows nature.Equally, carry material 612 by pipe unit 605 via the length that can extend implant 500, and the withdrawal pipe 605 subsequently, can make more implant 500 and new bone growth integrate in binding agent that uses effective amount or cement material fixation implant 500.

With reference now to Figure 75-78,, in preferred embodiment of the present invention, in implant 500, forms at least one implant/bone interface channel 615.Can resorbent binding agent or during bone cement when using, advantageously make material stream be present in or carry (Figure 77) at the intracavity of opening of a sizable at least part of following the whole contact surface between implant 500 and the bone 10.This structure provides the constant intensity of increase and the attachment that improved implant 500 arrives bone 10 usually.Similarly, after inserting and locating implant 500, adhesive material is injected/be transported in implant/bone interface channel 615.Preferably use screw 590 (Figure 78) or binding agent (not shown) that substrate 515 is attached to tibia 10.

Three part implant and processs of the test

Next with reference to figure 79-83, the vertical height of actuator housings 360 is fixing in position, and the surgeon can insert trial implants 500A for the side of the back of wedge shape framework implant 500 (Figure 80) and the side of front.For this reason, preferably provide the anatomy of the best that many surgeon are used for obtaining implant 500 to cooperate and be used for guaranteeing being coupled to the test regulator that the suitable localized size of the attachment of the substrate 515 in the osteotomy opening 110 increases gradually.

In case the side 520 of the back of the side 520 of the front of the suitable size of insertion implant 500 and suitable size, release and rotary actuator 350 are so that semi-coast apparatus for correcting 340 (Figure 44).Remove actuator housings 360 from rectification plate subsequently, and remove each plate (Figure 81).Bone graft and/or filling material of bone can be introduced into osteotomy, fill the major part in space 110.The substrate wall 515 of the suitable size of wedge shape implant 500 (Figure 82) is coupled in the open wedge 110.Subsequently by using threaded securing member 580 that substrate 515 is fixed to sidewall 520.Introduce the space of additional bone graft material and filling bone subsequently by the opening in the substrate 515 535.

With reference now to Figure 83,, the stability that provides the wedge shape implant 500 about the stability at osteotomy position to realize when being used in the RA of keeping hope about the osteotomy position.Directly contact with the cutting surface of the bone of osteotomy by the permission bone graft material,, provide the physiology compression and the stimulation of the needed necessity in space that promotes new organization and osteogenesis to pass through bone in the periphery inside of wedge shape implant.

Figure 84-87 shows here and to describe and in three part wedge shape implants shown in Figure 79-83 and another description of process of the test.

Single component implant and process of the test

With reference now to Figure 88 and 89,, show the wedge shape implant 545A that open the single component bottom.Equally, surgeon's service test implant 545A and trial implants 545A inserted osteotomy opening 110 to determine accurately to cooperate and the size of confirmed test implant 545A.Remove trial implants 545A and the implant 545 (Figure 89) of suitable size is inserted osteotomy space 110.Introduce the space of preferred bone graft material and filling bone by the opening 535 of base side 515.

Equally, be used in the wedge shape implant 545 realization stability that provide when keeping RA about the stability at osteotomy position.Directly contact with the cutting surface of the bone of osteotomy by the permission bone graft material,, provide the physiology compression and the stimulation of the space 110 needed necessity that promote new organization and osteogenesis to pass through bone in the periphery inside of wedge shape implant.

The alternate excision system that comprises two cutter orientation direction devices 705 and excision guide 710 700

Next with reference to figure 90-109, in alternate embodiment of the present invention, show the excision system 700 that comprises two cutter orientation direction devices 705 and be used to form the excision guide 710 of bone groove 715 (Figure 110).

Osteotomy orientation direction device 705 comprises two opposite cuttves 720,725 (Figure 90).

The cutter 720 (Figure 91) of back is configured to the rear side of the tibia 10 of nearside, and the cutter 725 (Figure 92) of front is configured to the front side of the tibia 10 of nearside.Each cutter member 720,725 has and allows it closely to be coupled to the bending radius of correspondence that horizontal excision 730 will be carried out the surface of the tibia 10 of (Figure 93) (Figure 91 and 92) therein.Each cutter member 720,725 is preferably enough wide with protection soft tissue and neurovascular structure during the osteotomy process.Each cutter member 720,725 preferably has the miniature lever of integrating with member self 735 (Figure 90).Handle 735 allows to dispose more easily and locate each cutter member 720,725 around the osteotomy position of suggestion.Length, width and the thickness of cutter member 720,725 can change, but general size is about 6-8 centimeter length, 3-5 centimetre wide and 1-3 millimeters thick.Each independent cutter 720,725 is inserted through the cutting mouth position and is directed around tibia 10.Can regulate the top rim 740 of each opposite cutter 720,725 so that aim at front-inclined-plane, back 745 (Figure 97) of cutter 720,725 and tibia.In case suitably locate each cutter member 720,725, use fixing hole 750 (Figure 96) and hold-down screw or sell 755 cutter fixed in position.Fixing hole 750 on each cutter member 720,725 is preferably located the superincumbent rim about 1-3 in 740 belows centimetre.Yet the cutter member 720,725 of every group of coupling 750 preferably has equal distance from top rim 740 to fixing hole.

Osteotomy guide 705 is preferably radiolucent, so that allow surgeon illuminated line photo or use fluoroscopy art when cutter member 720,725 is in suitable position.

(not shown) in one embodiment of the invention, in case place by cutting mouth, osteotomy orientation direction device member the 720, the 725th, extendible.

In Figure 98-103, show excision guide 710 in further detail.Excision guide 710 comprises the cutting groove 760 of at least one inclination, and is configured to be attached in the hold-down screw of cutter member 720,725 or sell on 755.

When using hold-down screw 755 that resected bone guide 710 is attached to tibia 10, suitably locate cutting groove 760 with respect to front-inclined-plane, back 765 (Figure 100) of tibia 10.Preferably by removing and reorientate the change that cutter member 720,725 and excision guide 110 is remained in the screw 755 of tibia or all introduce the hope on inclined-plane 765.The main body of excision guide 710 has the bending radius of the correspondence that allows to fit closely to bone surface 770 (Figure 101).Preferably, the thickness or the distance of the opposite side from bone surface 770 to excision guide 710 are passed tibia 10 for making resection instrument 775 (such as bone saw cutter 775) cut equably with identical depth of cut.Preferably, the system of the excision guide 710 of definite size is provided, have on the inboard with knee the interrelated (distance 285 of joint line below of excision inlet point, as obtaining, referring to Figure 36 from preoperative actinogram) and interrelated with the angle of inclination 290 (referring to Figure 36) of the plan of excising so that make resection instrument 775 (Figure 101) remain on the top cutting groove 760 of tibial tubercle 270 (referring to Figure 36) of front.The overall size scope of these excision guides 710 is preferably about 2-5 centimetre and passes tibia 10 (from the front to the back), about 3-5 centimeter length and about 5-10 millimeters thick.Cutting groove 760 preferably is positioned at approximately 3-5 centimetre of joint line (Figure 103) below, and the cutting angle 290 of inclination is 20-60 degree (Figure 102).

Use alternate excision system 700 (two cutter orientation direction devices 705 and excision guide 710) osteotomy process

Usually carry out customary knee endoprosthesis spectroscopy to remove any loose main body and to carry out common joint debridement.During arthroscopy, can carry out other mending course such as meniscus repairing, cartilage repairing or tissue regeneration process.After arthroscopy, the 3-5 centimetre of back-inboard border from the tibial tubercle of front to tibia forms front-inside skin cutting mouth below tibia shangguan nodel line.

With reference now to Figure 104-110,, preferably opens the external member that comprises excision system 700 at surgical site.System 700 comprise cutter member 720,725 and be provided for the accurate inclined-plane of bone groove 715 (Figure 110) or the plane and during cutting operation to the excision guide 710 of the protection of the structure of peripheral nerve and blood vessel.Two opposite cutter members 720,725 comprise and are inserted through the cutting mouth position and around as the cutter 720 of the back of bone 10 (Figure 104) guiding of the target of osteotomy and the cutter 725 of front.The withdrawal pes anserinus, the medial collateral ligament (MCL) that allows to observe the surface.Upwards shrink MCL to allow hugging the rear side of knee with the cutter member 720 insertion medial collateral ligament belows of back and around back-inboard border.The cutter 720 of back laterally arrive fibula the inboard the border and lean against on the fibular head 780 (Figure 105).The cutter member 725 of front inserts below the Patella tendon and arrives the front-outer boundaries 782 (Figure 106) of tibia 10.Each cutter member 720,725 has and allows it closely to be coupled to the bending radius of the correspondence of the bone surface that osteotomy will cut therein.These cutter members 720,725 can have different length, width and thickness, but common about 5-8 centimeter length, 3-5 centimetre wide and 1-3 millimeters thick of being of a size of.The upper rim 740 of each opposite cutter 720,725 is aimed at front-inclined-plane, back or plane with the nature of following the level ground along tibial plateau 785.Yet the position that the surgeon can also regulate arbitrary cutter 720,725 changes with the tibia inclined-plane of realizing specific hope.Joint line can also pass through to place base think of pin by knee capsule and below meniscus at district 790 (Figure 105 and 106) and determine.The use that base is thought pin helps the surgeon suitably to aim at each cutter member along joint line.The hold-down screw that each cutter member 720,725 provides by its fixing hole 750 usefulness separately or sell 755 fixing in position.

Next, select suitably slotted cutting guide 710.Preferably, (that is the system of) cutting guide 710, calf bone, medium tibia, or big tibia, each cutting guide main body have and allow it closely to be coupled to the bending radius of bone surface to provide corresponding overall dimension.Based on planning process before the operation, the surgeon selects the suitable cutting guide of size 710, coupling joint line below is used for the distance 285 (Figure 103) measured before the operation of inlet point, has the cutting angle (Figure 36) that remains on the inclination that tibial tubercle 270 tops need.The surgeon is attached cutting guide 710 or be connected to the hold-down screw of cutter member 720,725 or sell 755 (Figure 107).Plane or front-inclined-plane, back in conjunction with the plan of otch accurately limit the placement accurately of bone groove 715 (Figure 110).Cutting guide 710 preferably is configured to thickness or the distance from bone surface to opposite side is to make cutter 775 cut equably with identical depth of cut to pass tibia 10.The surgeon is coupled on the cast-cutting saw cutter 775 distance with the needs of the otch 715 determined before the labelling operation with cutter stopper 795 (Figure 109).The protection that provides neurovascular structure by cutter member 720,725; be attached suitable cutting guide 710; reach the suitable cutting distance of measuring and guaranteeing via cutter stopper 790; can carry out cutting operation safely by the groove 760 of cutting guide 710 (Figure 108 and 109); finish osteotomy or bone groove effectively, on the outside of the tibia 10 of nearside, keep minimum 1 centimetre of bone articulated section 800 (Figure 110) by cortical bone.Remove slotted cutting guide 710 subsequently, keep orientation direction device cutter member in position.

Preferably, and after forming the osteotomy otch via bone saw, the surgeon guarantees to cut cortical bone by the cortex of using thin osteotome and survey in the bone groove.In case determine the cutting cortical bone, the surgeon removes cutter member 720,725.Next, use is opened bone groove 715 (Figure 110) such as the open wedge device of mechanic jacks 90 (Figure 13-15) or alternate mechanic jacks 300 (Figure 44-47).Open wedge shape up to the angle that realizes wishing.Here, the surgeon preferably open again lentamente wedge shape about 2 millimeters to allow inserting wedge shape framework implant more easily.

By the RA of wishing, the surgeon prepares stable and fixing open wedge osteotomy and bone graft material inserted the osteotomy space subsequently.This can use such as the suitable implant of the size of a plurality of part implants 125 (Figure 19 and 20) that disclose above or alternate cuneiform osteotomy implant 500 (Figure 48-60,61-68,69-74,75-78,79-87 and 88-89) and realize.Each implant is determined size according to the open height of cuneiform osteotomy and the degree of depth of otch.By preoperative plan manoeuvre, the surgeon has determined correct implant size usually.Yet the surgeon also can select to use implant to test to determine correct implant size.

Extendible wedge shape implant 805

With reference now to Figure 111-125,, in another preferred embodiment of the present invention, show and comprise and the extendible wedge shape implant 805 that connects such as the device for opening of mechanic jacks 90 (Figure 13-15) or alternate mechanic jacks 300 (Figure 44-47) with two opposite sides 810 that form open wedge osteotomy.

Extendible wedge shape implant 805 comprises two opposite sides 810 (Figure 112), its surface constitute bone the space periphery and preferably in the periphery of side 810, form opening 815 (Figure 112).Base side 820 is coupled in the opening of cuneiform osteotomy and can be attached to side 810.In the side 810 each for along the horizontal breach 825 of its length to form two opposite framing components 830,835.With extendible material 840, the sheet of the flexibility of the material that biological example is compatible, the opposite framing component 830,835 of each side 810 is connected to each other.When (or in bone groove separately to form the space of bone) in two framing components 830,835 space at bone separately the time, extendible material 840 forms containment system around the periphery of implant 805 so that graft or filling material of bone are remained in the implant opening 815.

Horizontal breach side 810 can be successive form (Figure 113) at leading section 845 places; Perhaps breach side 810 can connect at leading section 845 places or combination (Figure 114); Perhaps breach side 810 can connect (Figure 115) with extendible material 850 in the front end; Perhaps breach side 810 can be leading section 845 places hinged (for example, using pivot pin) or the like in addition.Base side 820 preferably includes the path 855 (Figure 116) that is used for screw, bar or other securing member base side 820 being attached to the end 860 of horizontal breach side 810.Substrate 820 preferably also comprises hole or opening 865, can cross by this hole or opening 865 and inject or introducing bone graft or filling material of bone (Figure 116).In case inject or introducing, gap fill material makes inner graft material directly contact with the surface of the bone of osteotomy along the periphery expansion implant 805 and the extendible material 840 of osteotomy.

Extendible material 805 is preferably by any extendible biocompatible material manufacture or comprise any extendible biocompatible material.Extendible material 840 is preferably in essence can be resorbent or bone is inductive or bone conduction.

With reference now to Figure 117,, any extendible wedge shape implant 805 can be in conjunction with protruding, swell or other outstanding 870 (hereinafter jointly being called " protruding 870 " sometimes) on its bone interface surface.Protrude 870 and be shaped by this way, it allows easily implant 805 to be inserted osteotomy, in case but after implant cooperates in position, prevent that implant from moving.

Extendible wedge shape implant can comprise metal (for example, titanium or rustless steel) or other biocompatible material or polymer.The material of selecting can be for absorbable or can not be resorbent, also can be inductive or bone conduction for bone.

The basal component 820 of extendible wedge shape implant 805 is preferably by being inserted through substrate with bone screw 875 and entering the femur (not shown) or the bone of tibia 10 (Figure 118) provides fixing.Play fixed system by the basal component 820 that allows implant 805, replace traditional immobilized fixing head and bone screw thus, basal component 820 can comprise metal material, preferably promote combining of the biological composite material of integration of bone or one or more biological composite materials and metal, so that increase the intensity of the final load at osteotomy position.Preferably, basal component 820 is configured to normal healing at the osteotomy position to be provided enough weight supporting support and intensity period and begins subsequently to absorb along with the past of time again, prevents thus or reduces and repair and the stress shielding effect of new bone growth.Being used for such in the extendible wedge shape implant 805 can provide the active compression of passing the osteotomy position by resorbent basal component 820, promotes the higher rehabilitation of faster and intensity at osteotomy position thus.Equally, being used for fixing the bone screw 875 of basal component can be by forming with basal component 820 same or analogous materials.

With reference now to Figure 119 and 120,, horizontal breach wedge-shaped design 805 preferably also comprises the passage 880 that is used to carry biocompatible adhesive glue, bone cement, somatomedin or graft material by its solid material surface.These materials preferably can be resorbent.The importance that adds passage 880 is fixed on implant 805 in the osteotomy wedge gap better for when carrying glue or cement shape material; And/or in the situation of adding somatomedin or graft material, the ingrown formation that promotes bone is with fixation implant.

Can not resorbent cement or glue during when adding with fixation implant 805, allow in the cortical bone grows of nature and the surface that new bone is incorporated into the wedge shape implant and the surface by the wedge shape implant can be favourable; This can provide the stronger rehabilitation at better long-term safety shape and osteotomy position.Similarly, these binding agents and/or bone cement material can be carried by combination and the narrow tube 885 (Figure 119) of the passage 880 aligned opening 885A on the surface 890 that reaches implant 805.In case the material of binding agent or cement shape delivers into by pipe unit 885 and arrive the interface on surface of bone of the nature of implants 805 and tibia 10 by passage 880, withdrawal pipe unit 885.Such transport way provides adhesive area in the part of the contact surface 890 of the bone that allows nature.Equally, carry material by pipe unit 885 via the length of preferably extending implant 805, and the withdrawal pipe 885 subsequently, allow more implant 805 and new bone growth to integrate in binding agent that uses effective amount or cement material fixation implant 805.

Can resorbent binding agent or during bone cement, implant 805 is constructed so that alternatively material stream is stored in or conveying (Figure 120) the chamber 900 of following the whole contact surface between implant 805 and the bone in when using.Providing of chamber 900 increases strength of fixation and safety.Similarly, after inserting and locating implant 805, adhesive material is injected/be transported in implant/bone hub cavity 900.Subsequently with screw or binding agent attachment base side 820.

Use the osteotomy technology of extendible wedge shape implant

With reference now to Figure 121-130,, after forming bone groove as mentioned above, the surgeon is based on above-mentioned and select the suitable extendible wedge shape implant test 805A (Figure 121) of size in the preoperative process shown in Figure 35-37.Trial implants 805A is inserted osteotomy bone groove and the suitable implant of definite size.Remove test 805A and insert the correct implant 805 (not having base side 820) of size (Figure 122).

Next, assembling open wedge plate 805.Opening clapboard device 905 preferably provides the fixing hole 915 (Figure 122) that is designed to be coupled on the horizontal breach side 810 interior four attachment points 910 (Figure 123-125).Attachment point 910 provides support with the cuneiform osteotomy that allows implant 805 to insert wherein and opens.Panel assembly 905 is inserted bone groove, and four attachment points 910 of panel assembly 905 insert opening 915 (Figure 124) at the place, end of wedge shape implant 805.The surgeon is connected to actuator housings 360 (Figure 126) with two connector parts 920 of panel assembly 905.The surgeon uses actuator tool 410 rotary actuators 350 so that begin to open the wedge shape (Figure 127) of bone.When wedge shape was opened, the surgeon observed graduated labelling 380 on the sliding component 375.Open wedge shape up to the angle that reaches hope.Trigger stop pin 400 subsequently so that prevent sliding component 375 motions (Figure 128).Under actuator housings 360 still in position situation, subsequently preferred bone graft material is introduced the wedge gap 110 of bone.When space 110 almost is full of material, release actuator 350, and rotary actuator 350 is so that semi-coast apparatus for correcting 300.Remove actuator housings 360 from panel assembly 905 subsequently, carefully do not remove graft material.Select to be used for the suitable substrate wall 820 of the size of wedge shape implant 805 subsequently and substrate wall 820 is coupled to (Figure 129) in the open wedge.Subsequently by using threaded securing member 920 that substrate wall 820 is fixed to sidewall 810.The opening 865 of substrate wall 820 that subsequently can be by wedge shape 805 is introduced additional bone graft material and is further filled the space (Figure 130) of bone.

When keeping RA, use extendible wedge shape implant device 805 to realize stability at the osteotomy position.Directly contact with the cutting surface of the bone of osteotomy by the permission bone graft material, in the periphery of extendible wedge shape implant, provide the physiology compression and the stimulation of the needed necessity in space that promotes new organization and osteogenesis to pass through bone.

Should be appreciated that the present invention never is limited to the specific structure that discloses and/or illustrate in the drawings here, but also comprise within the scope of the invention any modification or equivalent.

Claims

1. osteotomy implant that is used to support open wedge osteotomy, this osteotomy implant comprises:

Be used to be arranged in second parts in the part of front of open wedge osteotomy; And

2. according to the osteotomy implant of claim 1, wherein, connecting device comprises the substrate parts with reciprocal first side and second side, wherein, first side is configured to selectively be attached first parts, and wherein, second side is configured to selectively be attached second parts.

3. according to the osteotomy implant of claim 2, wherein, substrate parts forms fixing hole therein so that allow by wherein placing fixture so that a plurality of part implants are anchored to tibia.

4. according to the osteotomy implant of claim 1, wherein, connecting device is included in the slotted joint between first parts and second parts.

5. osteotomy implant that is used to support a plurality of parts of open wedge osteotomy, this osteotomy implant comprises:

6. according to the osteotomy implant of a plurality of parts of claim 5, wherein, first bindiny mechanism comprises the first slotted joint that is formed between first parts and the 3rd parts, and wherein, second bindiny mechanism comprises the second slotted joint that is formed between second parts and the 3rd parts.

7. according to the osteotomy implant of claim 6, wherein, the first slotted joint comprises that first sun that is configured to be attached to each other protrudes and the first cloudy recess, and further wherein, first sun protrudes an extension from first parts and the 3rd parts, and the first cloudy recess is configured in in first parts and the 3rd parts another.

8. according to the osteotomy implant of claim 7, wherein, first sun protrudes from the 3rd parts and extends, and the first cloudy recess is configured in first parts.

9. according to the osteotomy implant of a plurality of parts of claim 6, wherein, the second slotted joint comprises that second sun that is configured to be attached to each other protrudes and the second cloudy recess, and further wherein, second sun protrudes an extension from second parts and the 3rd parts, and the second cloudy recess is configured in in second parts and the 3rd parts another.

10. according to the osteotomy implant of a plurality of parts of claim 9, wherein, second sun protrudes from the 3rd parts and extends, and the second cloudy recess is configured in second parts.

11. according to the osteotomy implant of a plurality of parts of claim 5, wherein, when linking together, first parts, second parts and the 3rd parts form the space betwixt, and wherein, the space is the center of corresponding open wedge osteotomy roughly.

12. according to the osteotomy implant of a plurality of parts of claim 11, wherein, first parts, second parts and the 3rd unit architecture are placed into graft material in the space for allowing.

13. according to the osteotomy implant of a plurality of parts of claim 12, wherein, first parts, second parts and the 3rd unit architecture are for allowing graft material compacting in the space.

14. osteotomy implant according to a plurality of parts of claim 5, wherein, first parts comprise the first wall with first packet size, second parts comprise second wall with second packet size, and further wherein, first packet size of first parts and second packet size of second parts differ from one another, so that can arrange AP tibia inclined-plane exactly.

15. osteotomy implant according to a plurality of parts of claim 5, wherein, first parts have first surface and second surface, the bone surface that first surface is configured to be placed in the mouth in osteotomy space and second surface is configured to contiguous open wedge osteotomy is placed, and further wherein, first parts form first passage therein between first surface and second surface, so that allow by first passage from first surface, and material is provided to the bone/implant interface that is formed between first parts and the bone to the second surface injection material.

16. a plurality of part implants according to claim 15, wherein, first parts form first inlet that enters first passage at first surface, and further wherein, first inlet structure is for being visited by the surgeon after the first parts adjacent bone is placed.

17. according to a plurality of part implants of claim 16, wherein, first parts form a plurality of outlets at second surface.

18. according to the osteotomy implant of claim 15, wherein, the material of selection comprises select at least a from the group that comprises biocompatible adhesive glue, bone cement, biomaterial, somatomedin and graft materials.

19. osteotomy implant according to a plurality of parts of claim 15, wherein, second parts have the 3rd surface and the 4th surface, the 3rd surface is configured to place the bone surface that osteotomy space and the 4th surface be configured to contiguous open wedge osteotomy and places, and further wherein, second parts form second channel therein between the 3rd surface and the 4th surface, so that allow by second channel, and material is provided to the bone/implant interface that is formed between second parts and the bone from the 3rd surface to the four surperficial injection materials.

20. a plurality of part implants according to claim 16, wherein, second parts form second inlet that enters second channel on the 3rd surface, and further wherein, second inlet structure is for being visited by the surgeon after the second parts adjacent bone is placed.

21. according to a plurality of part implants of claim 20, wherein, second parts form a plurality of outlets on the 4th surface.

22. according to a plurality of part implants of claim 19, wherein, second channel be configured to allow to inject from the group that comprises osseocolla, cement, biomaterial and graft materials select a kind of.

23. a plurality of part implants according to claim 5, wherein, first parts have first absorption rate again in the bone, second parts have second absorption rate again in the bone, the 3rd parts have the 3rd absorption rate again in the bone, wherein, first again absorption rate and second absorption rate is roughly mutually the same again, and the 3rd again absorption rate roughly with first again absorption rate and second absorption rate is different again.

24. according to a plurality of part implants of claim 23, wherein, the 3rd parts are different with second parts with first parts at least one aspect of selecting from comprise the group aspect following: the biological material ingredients that differs from one another; The biological composite composition that differs from one another; With the prescription that differs from one another.

25. according to a plurality of part implants of claim 5, wherein, the 3rd parts form first fixing hole therein so that allow first fixture by wherein placing so that a plurality of part implants are anchored to tibia.

26. according to a plurality of part implants of claim 25, wherein, the 3rd parts form second fixing hole therein so that allow second fixture by wherein placing so that a plurality of part implants are anchored to tibia.

27. a plurality of part implants according to claim 26, wherein, first fixing hole has the entering part on the 3rd parts and withdraws from part, first fixing hole defines from the entering part of the 3rd parts to first longitudinal axis that withdraws from part, second fixing hole has the entering part on the 3rd parts and withdraws from part, second fixing hole defines from the entering part of the 3rd parts to second longitudinal axis that withdraws from part, and first longitudinal axis and second longitudinal axis are not parallel to each other so that guide first fixture to enter the first of tibia and guide second fixture to enter the second portion of tibia, make the second portion of the first of tibia and tibia on the opposite side of the 3rd parts.

28. according to the osteotomy implant of a plurality of parts of claim 5, wherein, first parts, second parts and the 3rd parts each be configured to the inside of the bone groove of open wedge osteotomy be assembled with each other.

29. according to the osteotomy implant of a plurality of parts of claim 5, wherein, first parts, second parts and the 3rd parts each be configured to the outside of the bone groove of open wedge osteotomy be assembled with each other.

30. according to the osteotomy implant of a plurality of parts of claim 5, wherein, first parts, second parts and the 3rd unit architecture are the bone groove that supports open wedge osteotomy from the front side of the bone groove of open wedge osteotomy to rear side.

31. an orientation direction device that is used in tibia carrying out open wedge osteotomy, this orientation direction device comprise the joint line of the part that is used to aim at the orientation direction device and tibia aligning parts, be used for that the orientation direction device is fixed to the fixed part of tibia and be used for the orientation direction device is connected to the link of cutting guide.

32. according to the orientation direction device main body of claim 31, wherein, aligning parts comprises and being configured to and the aligned top surface of the joint line of tibia.

33. according to the orientation direction device of claim 31, wherein, the orientation direction device forms a pair of fixing hole therein, and fixed part comprises and be configured to a pair of hold-down screw fixing hole placed by this, so that the orientation direction device is fixed to tibia.

34. according to the orientation direction device of claim 31, wherein, link comprises the attachment screw that threadably engages the orientation direction device.

35. cutting guide that is used in tibia, carrying out open wedge osteotomy, this cutting guide has the guide attachment parts that are used for selectively cutting guide being attached to tibia, and cutting guide forms therein and is configured to guide cutter to enter tibia so that form the angled cutting groove of bone groove in tibia.

36. according to the cutting guide of claim 35, wherein, cutting guide forms the path by wherein, and guide attachment parts comprise selectively by this access arrangements so that cutting guide is anchored to the attachment screw of tibia.

37. according to the cutting guide of claim 36, wherein, guide attachment unit architecture is for selectively directly to anchor to tibia with attachment screw.

38. according to the cutting guide of claim 36, wherein, guide attachment unit architecture is for selectively to anchor to the orientation direction device that is attached to tibia with attachment screw.

39. according to the cutting guide of claim 35, wherein, angled cutting groove is roughly parallel to the joint line of tibia.

40. according to the cutting guide of claim 35, wherein, angled cutting groove is arranged as with the joint line of tibia and becomes given angle, so that form the bone groove of the angle that becomes given with the joint line of tibia.

41. the protector member of a front that is used to carry out open wedge osteotomy and the protector member of back; in the protector member of front and the protector member of back each has first end; the second end and between first end and the second end, have given length; each has the connector part that is configured to anchor to tibia the first end of the protector member of front and the protector member of back; each has the shape of fixed wheel exterior feature closely to be similar to the front side and the rear side of tibia respectively the protector member of front and the protector member of back; wherein; each inserts the second end of the second end of the protector member of front and the protector member of back towards front side and rear side respectively from the inboard around tibia, and the first end of the protector member of the first end of the protector member of front and back each anchor to tibia.

42. according to the protector member of the front of claim 41 and the protector member of back; wherein; the connector part of the connector part of the protector member of front and the protector member of back is configured to selectively be attached to the cutting guide of tibia, so that the protector member of front and the protector member of back are anchored to tibia.

43. according to the protector member of the front of claim 41 and the protector member of back; wherein; the connector part of the connector part of the protector member of front and the protector member of back is configured to selectively use hold-down screw directly to be attached to tibia, so that the protector member of front and the protector member of back are anchored to tibia.

44. mechanic jacks that is used in tibia, carrying out open wedge osteotomy, this mechanic jacks comprises the jack attachment parts that are used for selectively jack being attached to tibia, this mechanic jacks has a pair of plate with reciprocal first end and the second end, this first end to plate be configured to roughly keep with each other together and be configured to be placed in the bone groove in the tibia, and this second end to plate be configured to selectively to locate (i) from this to the second end of plate roughly with together primary importance each other, (ii) arrive this second end second position away from each other, so that diverge to tibia at the bone groove place to plate.

45. according to the mechanic jacks of claim 44, wherein, jack attachment parts comprise the housing parts that forms through hole, this hole configuration is for allowing to be attached screw by wherein threadably to engage with the orientation direction device that is attached to tibia.

46. mechanic jacks according to claim 44, also comprise having and be approximately perpendicular to each other the first that arranges and the turbine of second portion, wherein, define the plate longitudinal axis from this first end to this line to the second end of plate to plate, wherein, first be arranged in the first orientation that is approximately perpendicular to the plate longitudinal axis in case between the primary importance and the second position drive plate, and second portion is arranged in the second orientation that is roughly parallel to the plate longitudinal axis so that allow actuator tool to engage with the angle that is roughly parallel to the plate longitudinal axis.

47. a system that is used for carrying out open wedge osteotomy in tibia, this system comprises:

48. system according to claim 47, wherein, a plurality of part implants form fixing hole therein, and comprise and be configured to place and be arranged in the tibia so that a plurality of part implants are anchored to the fixture of tibia by the fixing hole in a plurality of part implants.

49. according to the system of claim 47, wherein, the connecting device of a plurality of part implants comprises the slotted joint that is formed between first parts and second parts.

50. system according to claim 47, wherein, the connecting device of a plurality of part implants comprises the base part that is used to be arranged between the first and second parts, base part has reciprocal first side and second side, and base part is configured to selectively respectively first parts and second parts are connected to its first side and second side, so that selectively with base part first parts and second parts are connected to each other.

51. a method that is used for carrying out open wedge osteotomy in tibia, this method comprises:

Use fixed part that the orientation direction device is fixed to tibia;

A plurality of part implants are inserted tibia.

52. the method that is used in tibia, carrying out open wedge osteotomy according to claim 51, wherein, aligning parts comprises the top surface of orientation direction device, and further wherein, aim at orientation direction device and the step of the joint line of tibia and comprise the top surface of aiming at the orientation direction device and the joint line of tibia.

53. the method that is used in tibia, carrying out open wedge osteotomy according to claim 51, wherein, fixed part comprises that two hold-down screws and orientation direction device form two therein and be configured to respectively by wherein receiving each the fixing screw hole in two hold-down screws, and the step that further wherein, the orientation direction device is fixed to tibia comprises in two hold-down screws each is attached in the tibia by the orientation direction device.

54. the method that is used in tibia, carrying out open wedge osteotomy according to claim 51, wherein, cutting guide forms the path that passes through wherein, wherein, guide attachment parts comprise selectively by this access arrangements so that cutting guide is anchored to the attachment screw of tibia, and wherein, the step that cutting guide is attached to the orientation direction device comprises positioned adjacent guide location cutting guide, the path of screw by cutting guide that be located by connecting, and threadably engage attachment screw and orientation direction device.

55. the method that is used in tibia, carrying out open wedge osteotomy according to claim 51, wherein, start mechanic jacks and also comprise and read the graduated step that is arranged on the mechanic jacks, so that at the bone groove place tibia diverged to as the given distance by the scale indication so that this is moved to this step to the second end second position away from each other of plate to the second end of plate from primary importance.

56. according to the method that is used for carrying out open wedge osteotomy in tibia of claim 51, wherein, the step of a plurality of part implants being inserted tibia also is included in the step of on-the-spot assembling implant, so that provide infringement minimum surgical procedures.

57. according to the method that is used for carrying out open wedge osteotomy in tibia of claim 51, wherein, the step of a plurality of part implants being inserted tibia also is included in the outside step of assembling implant of open wedge osteotomy.

58. a system that is used for carrying out open wedge osteotomy in tibia, this system comprises:

59. a method that is used for carrying out open wedge osteotomy in tibia, this method comprises:

Aim at the joint line of cutting guide and tibia;

A plurality of part implants are inserted tibia.

60. the method that is used for execution open wedge osteotomy in tibia according to claim 59 also comprises the protector member of front and the protector member of back; wherein; the connector part of the connector part of the protector member of front and the protector member of back is configured to selectively use hold-down screw directly to be attached to tibia; so that respectively the protector member of front and the protector member of back are anchored to tibia; wherein; second alignment fiducials on first alignment fiducials on the protector member of front and the protector member of back allows to aim at protector member and the protector member of back and the joint line of tibia of front; wherein; aim at the step of protector member that cutting guide and the step of the joint line of tibia comprise the protector member of aiming at the front and back and the joint line of tibia and the protector member of the protector member of front and back is attached to tibia, and the step that cutting guide is attached to tibia is comprised that being attached position and second based on first is attached the position at position and is attached cutting guide so that provide the first attachment position of the protector component limit by the front and the step at the second attachment position of the protector component limit by the back.

61. an osteotomy implant that is used to support open wedge osteotomy, this osteotomy implant comprises:

62. osteotomy implant according to claim 61, also be included in the bottom parts that extends and extend to leading edge between two opposite sidewalls from base part, and wherein, bottom parts has the 3rd height, and first height of base part is opened part greater than the 3rd height of bottom parts so that form between two opposite sides.

63. according to the osteotomy implant of claim 61, wherein, base part forms at least one and is used for by wherein inserting wherein the opening of passing through of material.

64. according to the osteotomy implant of claim 63, wherein, material is from comprising allograft bone; The autograft bone; The bone sub that demineralizes; Bone graft material; With select in the group of bone cement at least a.

65. according to the osteotomy implant of claim 61, wherein, two opposite sides are roughly with parallel to each other.

66. osteotomy implant according to claim 61, also comprise a series of protrusions that extend from the bone interface surface of two opposite sidewalls, wherein, this protrusion is configured to allow opposite sidewall to insert in the open wedge osteotomy and prevents that opposite sidewall from moving out open wedge osteotomy.

67. according to the osteotomy implant of claim 61, wherein, two opposite sidewalls define therein and are used for by wherein carrying the passage of the material of selecting.

68. osteotomy implant according to claim 67, also comprise conveyer device, this conveyer device comprises the pipe with length and diameter, this pipe forms a series of openings along its length, this diameter is configured to be placed in the main portions of passage, and this series of openings is configured to a series of components of respective channel.

69. according to the osteotomy implant of claim 61, wherein, two opposite sidewalls at its bone interface surface upper limit routing opening in case the material that allows to select by wherein carrying.

70. according to the osteotomy implant of claim 69, wherein, the material of selection comprises from comprising biocompatible adhesive glue; Bone cement; Somatomedin; With select in the group of graft materials at least a.

71. an osteotomy implant that is used to support open wedge osteotomy, this osteotomy implant comprises:

Two opposite sidewalls that extend from first end and the second end respectively, two opposite sidewalls have the 3rd end and the 4th end, extend from base part the 3rd end, second highly equals first height in the base part at place, the 3rd end, in two opposite sidewalls at the 4th end place each has the 3rd height, and the 3rd height is placed on each the 4th end in two opposite sidewalls in the part in distally of open wedge osteotomy so that allow less than second height.

72. according to the osteotomy implant of claim 71, wherein, two opposite walls are roughly with parallel to each other.

73. according to the osteotomy implant of claim 71, wherein, two opposite sidewalls respectively in the 3rd end of each in opposite sidewall and the district between the 4th end near each other.

74. according to the osteotomy implant of claim 71, wherein, base part forms at least one and is used for by wherein inserting wherein the opening of passing through of material.

75. according to the osteotomy implant of claim 71, wherein, material is from comprising allograft bone; The autograft bone; The bone sub that demineralizes; Bone graft material; With select in the group of bone cement at least a.

76., also be included between two opposite sidewalls the adapter that extend the 3rd end of each from sidewall and the position between the 4th end respectively according to the osteotomy implant of claim 71.

77. according to the osteotomy implant of claim 71, wherein, two sidewalls can be selectively from being separated from each other.

78. according to the osteotomy implant of claim 77, wherein, what base part can be selected separates from two sidewalls.

79. according to the osteotomy implant of claim 78, wherein, the material of selection comprises from comprising biocompatible adhesive glue; Bone cement; Somatomedin; With select in the group of graft materials at least a.

80. osteotomy implant according to claim 77, also comprise a series of protrusions that extend from the bone interface surface of two opposite sidewalls, wherein, this protrusion is configured to allow opposite sidewall to insert in the open wedge osteotomy and prevents that opposite sidewall from moving out open wedge osteotomy.

81. according to the osteotomy implant of claim 71, wherein, two opposite sidewalls define therein and are used for by wherein carrying the passage of the material of selecting.

82. 1 osteotomy implant according to Claim 8, wherein, the material of selection comprises from comprising biocompatible adhesive glue; Bone cement; Somatomedin; With select in the group of graft materials at least a.

83. 1 osteotomy implant according to Claim 8, also comprise conveyer device, this conveyer device comprises the pipe with length and diameter, this pipe forms a series of openings along its length, this diameter is configured to be placed in the main portions of passage, and this series of openings is configured to a series of components of respective channel.

84. according to the osteotomy implant of claim 71, wherein, two opposite sidewalls define passage so that the material that allows to select is carried therein on its bone interface surface.

85. 4 osteotomy implant according to Claim 8, wherein, the material of selection comprises from comprising biocompatible adhesive glue; Bone cement; Somatomedin; With select in the group of graft materials at least a.

86. an osteotomy implant that is used to support open wedge osteotomy, this osteotomy implant comprises:

87. 6 osteotomy implant according to Claim 8, wherein, basal component defines therein and is used for this group adapter by wherein arranging basal component is connected to each path of two opposite sides.

88. 6 osteotomy implant according to Claim 8, wherein, at least one that select from the group that comprises base part and two opposite sidewalls defines the opening by wherein, and this open construction is to be used between two opposite sides parts the material of selecting being inserted open wedge osteotomy.

89. 8 osteotomy implant according to Claim 8, wherein, the material of selection comprises from comprising biocompatible adhesive glue; Bone cement; Somatomedin; With select in the group of graft materials at least a.

90. 6 osteotomy implant according to Claim 8, also comprise a series of protrusions that extend from the bone interface surface of two opposite sidewalls, wherein, this protrusion is configured to allow opposite sidewall to insert in the open wedge osteotomy and prevents that opposite sidewall from moving out open wedge osteotomy.

91. 6 osteotomy implant according to Claim 8, also comprise each the open wedge panel assembly that is used for opening two opposite sidewalls at the second end, this open wedge plate has each this that be configured to be attached in two opposite sidewalls to each four attachment points in the framing component, with two adapters that are used to be attached to jack mechanism, wherein, the open wedge panel assembly is configured to support when each the second end in sidewall is relative to each other expanded two opposite sidewalls.

92. an osteotomy implant that is used to support a plurality of parts of open wedge osteotomy, this osteotomy implant comprises:

Wherein, in the time of in being arranged in open wedge osteotomy, first parts and second parts form the U-shaped wall.

93. according to the osteotomy implant of a plurality of parts of claim 92, wherein, first parts and second unit architecture contiguously in open wedge osteotomy are arranged so that contact each other each other for being used for.

94. according to the osteotomy implant of a plurality of parts of claim 93, wherein, first parts and second unit architecture with are arranged in open wedge osteotomy for being used for with being connected to each other.

95. according to the osteotomy implant of a plurality of parts of claim 92, wherein, first parts and second unit architecture with are arranged in open wedge osteotomy for being used for with being connected to each other.

96. osteotomy implant according to a plurality of parts of claim 92, also comprise the 3rd parts in the part of the inboard that is configured to be arranged in open wedge osteotomy, wherein, in the time of in being arranged in open wedge osteotomy, first parts, second parts become the U-shaped wall with three-parts configuration.

97. osteotomy implant according to a plurality of parts of claim 96, wherein, first parts are arranged so that contact each other for being used for being close in open wedge osteotomy each other with second unit architecture, and second parts are arranged so that contact each other for being used for being close to each other in open wedge osteotomy with the 3rd unit architecture.

98. according to the osteotomy implant of a plurality of parts of claim 97, wherein, first parts are to be used for being arranged in the open wedge osteotomy under situation about directly not contacting each other with second unit architecture.

99. an osteotomy implant that is used to support open wedge osteotomy, this osteotomy implant comprises:

The U-shaped wall forms wherein the visit mouth of pass through that enters interior section from exterior section, and wherein, visit mouthful allows a material externally partly and between the interior section to pass through.

100. according to the osteotomy implant of claim 99, wherein, when the osteotomy implant was arranged in the open wedge osteotomy, the visit outlet structure was in the part of the inboard of U-shaped wall.

101. according to the osteotomy implant of claim 99, wherein, when the osteotomy implant was arranged in the open wedge osteotomy, the visit outlet structure was in the part of the back of U-shaped wall.

102. according to the osteotomy implant of claim 99, wherein, when the osteotomy implant was arranged in the open wedge osteotomy, the visit outlet structure was in the part of the front of U-shaped wall.

103. according to the osteotomy implant of claim 99, wherein, the U-shaped wall forms wherein the additional visit mouth of pass through that enters inner part from the part of outside.

104. according to the osteotomy implant of claim 103, wherein, in visit mouthful and the additional visit mouthful one is configured to when by visit mouthful and additional another injection material of visiting in the mouth, the permission material overflows with internally part and withdraws from.

105. an osteotomy implant that is used to support a plurality of parts of open wedge osteotomy, this osteotomy implant comprises:

106. according to a plurality of part implants of claim 105, wherein, first parts are arranged so that contact each other for being used for being close to each other in open wedge osteotomy with second unit architecture.

107. according to a plurality of part implants of claim 106, wherein, in the time of in being arranged in open wedge osteotomy, first parts and second parts form the U-shaped wall.

108. a plurality of part implants according to claim 105, also comprise the 3rd parts in the part of the inboard that is configured to be arranged in the open wedge assembly, wherein, the 3rd parts comprise the 3rd material, and further wherein, first material, second material and the 3rd material with differ from one another.

109. a plurality of part implants that are used to support open wedge osteotomy, this osteotomy implant comprises:

Be configured to be arranged in the 3rd parts in the part of inboard of open wedge osteotomy;

And

110. according to a plurality of part implants of claim 109, wherein, the 3rd material is different with second material with first material.

111. according to a plurality of part implants of claim 109, wherein, each in first material, second material and the 3rd material with differ from one another.