CN100471471C - Open wedge osteotomy system and surgical method - Google Patents

Abstract

Surgical apparatus and methods for open wedge osteotomy surgery. The apparatus includes an osteotomy implant having a plurality of pieces of first, second and third components and a coupling mechanism. A method for performing an open wedge osteotomy includes a cutting guide, a 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 PatentApplication sequence number 60/569,545, VincentP.Novak proposed on May 7th, 2004, OPEN WEDGE OSTEOTOMY SYSTEMAND SURGICAL TECHINQUE (lawyer's case NOVAK-1PROV) by name;

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

(3) unsettled existing U.S. Provisional PatentApplication sequence number 60/626,305, VincentP.Novak proposed on November 9th, 2004, OPEN WEDGE OSTEOTOMY SYSTEMAND SURGICAL TECHINQUE (lawyer's case NOVAK-3PROV) 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 fixinghead 5 that provides specific AP inclined-plane to change astibia 10 can be provided the surgeon.With the difficulty of this approach is the only fact of the part insupports 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 the solid slug (that is, allograft bone or synthetic bone) of bone graft, with help readjust the AP inclined-plane and, (ii) utilize fixinghead 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 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 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;

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, 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.

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:

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

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:

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 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

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;

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;

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.

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.

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:

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.

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 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.

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:

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.

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 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, 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 second parts in the part of front 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 neworientation direction device 20 of parts of the preferred embodiment of the new osteotomy system of explanation;

Fig. 6-12 is the sketch map of thenew 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 ofpart 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 alternatenew 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 thenew 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 111-130 is the sketch map of explanation for the new extendiblewedge shape implant 805 of the alternate embodiment of the new a plurality ofpart 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 cuttingguide 45 oforientation 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 thesuitable protector member 70,75 of cuttingguide 45, protect tibia soft tissue and nerve and blood vessel structure on every side thus;

(iv) cuttingguide 45 is fixed toorientation direction device 20, and subsequentlyprotector member 70,75 is fixed to cuttingguide 45;

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

(vi) makecutter 65 by being formed on the guidingtank 50 in the cuttingguide 45 and passing throughtibia 10, follow thepath 65A that sets up by cuttingguide 45, reached proper depth up to otch;

(thecutter 65 of vii) withdrawing;

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

(ix) a plurality ofpart implants 125 are inserted theosteotomy 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 ofpart 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 positionorientation direction device 20 along the joint line (Fig. 3) of tibia 10.Particularly, the top oforientation 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 throughorientation direction device 20 and entertibia 10 so that after the top alignment of the top oforientation direction device 20 andtibia 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.

Cuttingguide 45

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

More specifically, and with reference now to Fig. 8 and 9, cuttingguide 45 comprises and receives attachment screw 40 (Fig. 7) so that cuttingguide 45 is installed to the throughhole 55 oforientation direction device 20, thus with respect to the angled cuttinggroove 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 cuttingguide 45, is used forprotector member 70,75 (below seeing) is installed to cutting guide 45.Cutter 65 (Fig. 9) selectively are inserted through guidingtank 50, makecutter 65 to cut alongpath 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, cuttingguide 45 preferably includesprotector member 70,75 with protection soft tissue and nerve and blood vessel structure during the bonecutting.Protector member 70,75 (i) inserts patient by little inner surface otch; (ii) the preceding and rear surface ofclose tibia 10 is below skin histology; And (iii) usesectional 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) oftibia 10, andprotector member 75 fixed wheel is wide for being used for the rear side (Figure 12) oftibia 10 especially.Eachprotector 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 cuttingguide 45 and enters thecutter 65 of tibia 10.Whencutter 65 cut bone by cuttinggroove 50 and along the angle of wishing,protector member 70,75 guaranteed thatcutter 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 cuttingguide 45 andprotector 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 95,100insertion tibias 10, and subsequently mechanic jacks 90 is fixed to orientation direction device 20.Can usemechanic jacks 90 that metallic plate 95,100 is relative to each other opened subsequently, so that intibia 10, form the osteotomy space of wishing.

Alternatively, and see Figure 14 now, be fixed toorientation direction device 20 and operation with when opening thebone 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 ofspace 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 thepart 105 of the front of mechanic jacks 90, cutter 95,100 is stayed in the bone and is openedosteotomy space 110 in thetibia 10 so that remain on.

A plurality ofpart implants 125

In case used mechanic jacks 90 intibia 10, to openosteotomy space 110, in the space, disposed a plurality ofpart 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 thesubstrate part 140 to use hold-down screw 175 (Figure 26) that theimplant 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 entertibia 10 on every side in space 110.More specifically, in the bone surface in thespace 110 of thebone interface surface 140A (Figure 23) ofsubstrate part 140 joint formation tibia 10.Fixinghole outlet 160A forms bysurperficial 140A so that thetibia 10 around permission hold-down screw 175 (Figure 26) feeding.Hold-down screw 175 enterstibia 10, thus substrate 140 (and so whole implant 125) is fixed totibia 10.

Thepart 130 of the front ofimplant 125 and thepart 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 ofpart 135 of thepart 135 of thepart 130 of front and back and part infront 130 and back and leaves, and is communicated with part/boneinterface thus.Inlet 165 allows material (for example, bone cement, bone paste, growth reinforcing agent or the like) to be transported to part/bone interface.

Thepart 130 of front, thepart 135 of back and/orsubstrate 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, thepart 130 of front, thepart 135 of back andsubstrate part 140 are all formed by the biomaterial and/or the biological composite that absorb in the host bone again, and thepart 130 of front and thepart 135 of back form and make them absorb sooner again than substrate part 140.By formingsubstrate 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 thespace 110 for osteotomy.

Preferably, during process, zone in theosteotomy 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 theosteotomy space 110 of a plurality ofpart implant 125 restrictions.This can (i) infront part 130 and after thepart 135 of back disposed in the osteotomy space, and (ii)realization substrate part 140 is fixed topart 130 and 135 before.Alternatively, additional through hole (not shown) can extend throughsubstrate part 140, even allow still can visit the inside inosteotomy 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 usingorientation direction device 20 and cuttingguide 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 offemoral 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 offemoral head 205 to the tibia that is positioned at the nearside in the knee endoprosthesis of the outside is drawn another lines 215.Draw the3rd line 225 from the center in tibia-astragalus joint 210 to thesame point 220 in the knee endoprosthesis of the outside.Theangles 230 that intersect to form by twolines 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 cuttingguide 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 toline 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 andline 250 intersect will pass the bone groove oftibia 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 atline 265, and can calculate according to point 240 and the distance of putting between 275 285.

From passing through anexcision 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 theinlet point 285 on the inboard cortex of bone groove; (ii) Qie Chu the degree ofdepth 295; And (iii) pass theangle 290 oftibia 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:

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

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

(iv) cuttingguide 45 is fixed toorientation direction device 20, and subsequentlyprotector member 70,75 is fixed to cuttingguide 45;

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

(vi) makecutter 65 by being formed on the guidingtank 50 in the cuttingguide 45 and passing throughtibia 10, follow thepath 65A that sets up by cuttingguide 45, reached proper depth up to otch;

(thecutter 65 of vii) withdrawing;

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

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

Preferably, the inside with the osteotomy space in a plurality ofpart 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.

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.

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, make little bone cutting collar along the edge of the distant place of bone articulated section by wishing rise so that remove the possible stress that can exist, and the risk of fracturing when helping to reduce osteotomy otch in being opened to wedge gap 110.Comprise with regard to this method that such stress rises and reduce step, preferably after forming bone groove and opening the osteotomy space, carried out this work in the past.

Alternate mechanic jacks 300

With reference now to Figure 38-47,, in alternate form of the present invention, mechanic jacks 300 can substitute above-mentionedmechanic jacks 90 and use.

More specifically, mechanic jacks 300 preferably includes two plates 305,310.Plate 305 superincumbent location arrangements in the tibial bone otch, andplate 310 in the location arrangements of bottom in the tibial bone otch.As shown in figure 38, plate 305,310 can comprise one or more different shapes 315,320,325 or the like.The preferred shape of plate 305,310 is a Long Circle, is of a size of about 15-20 mm wide and about 40-70 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 theend 330 in their distally or are attached to each other and allow theend 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, thebone groove 405 that forms before plate 305,310 slips into.Preferably usemanual driver instrument 410 at the directionrotary 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 thescale 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, thestop pin 400 that preferably is positioned on the side ofactuator housings 360 slips into suitable position so that prevent slidingcomponent 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 ofpart 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 thealternate implant 500 of replacing above-mentioned a plurality ofpart 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 information osteotomy space 110 and the design (Figure 48) that conduct is used for supporting withRA 505 pillar oftibias 10.

The same with a plurality ofpart implant 125, the master-plan of theimplant 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 openinterior periphery 525, front side oredge 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 theend 510 in distally, andsubstrate 515 becomes fillet (Figure 51) at its outer side.The degree of depth of the approximate osteotomy of the length ofimplant 500, its size is typically about the 40-70millimeter.Implant 500 is constructed so that integrally, it passes the periphery thattibia 10 is closely followed inosteotomy 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 ofimplant 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 meetscuneiform osteotomy.Implant 530 extends tosubstrate 515 from leadingsection 510 can have width identical or variation (for example, widening).Thesubstrate 515 ofimplant 530 preferably includes one or more holes or theopening 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, comprisessubstrate 515, twosides 520 andbottom parts 540; These four parts limit openingperiphery 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 comprisesubstrate 515 and two opposite sidewalls 520.In the situation ofimplant 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 eachsidewall 530, and connecting plate connects together two substrate half ones.Forming framework 565,570 and 575 various parts preferably insertsosteotomy space 110 respectively and is fixed together in the situation that comprises thewedge 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 inframework 570 and 575 situation, insert at last and be connectedsubstrate.Substrate 515 preferably uses preferably identical with the material of implant screw, bar or any other fastening device to be attached toside 520 at 580 places.

A plurality of part implants 565,570 and/or 575 and the advantage of the uniqueness of a plurality ofpart implants 125 of describing before for thewall 520 by inserting a certain height and size and insert theopposite 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, anyaforementioned implant 500 and aforementioned a plurality ofpart 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 insertedosteotomy space 110, in case but afterimplant 500 cooperates in position, prevent thatimplant 500 from moving.

Variouswedge 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 totibia 10 further by screw or bar 590 are preferably entered thesubstrate 515 that tibia 10 places implant 500 bysubstrate 515 angularly.Can guide screw or bar 590 in the above and below enter tibia.In addition, thesubstrate 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 thepassage 595 of bone contact surface 600.These materials are preferably can be resorbent.It is important feature thatpassage 595 is provided in implant, because (i) when carrying glue or cement shape material bypassage 595, it can allow implant to be fixed inosteotomy 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 thepassage 595 alignedopenings 610 on thesurface 600 that reaches implant 500.In case thematerial 612 of binding agent or cement shape delivers into bypipe unit 605 and arrive the surface of bone of the nature of thesurface 600 ofimplants 500 andtibia 10 bypassage 595, withdrawal pipe unit 605.Such transport way provides adhesive area in thesurface 600 of thecontact implant 500 of the bone that allows nature.Equally, carrymaterial 612 bypipe unit 605 via the length that can extendimplant 500, and thewithdrawal pipe 605 subsequently, can makemore implant 500 and new bone growth integrate in binding agent that uses effective amount or cementmaterial fixation implant 500.

With reference now to Figure 75-78,, in preferred embodiment of the present invention, inimplant 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 betweenimplant 500 and the bone 10.This structure provides the constant intensity of increase and the attachment that improvedimplant 500 arrivesbone 10 usually.Similarly, after inserting and locatingimplant 500, adhesive material is injected/be transported in implant/bone interface channel 615.Preferably use screw 590 (Figure 78) or binding agent (not shown) thatsubstrate 515 is attached totibia 10.

Three part implant and processs of the test

Next with reference to figure 79-83, the vertical height ofactuator 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 obtainingimplant 500 to cooperate and be used for guaranteeing being coupled to the test regulator that the suitable localized size of the attachment of thesubstrate 515 in theosteotomy opening 110 increases gradually.

In case theside 520 of the back of theside 520 of the front of the suitable size ofinsertion implant 500 and suitable size, release androtary 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.Thesubstrate wall 515 of the suitable size of wedge shape implant 500 (Figure 82) is coupled in the open wedge 110.Subsequently by using threaded securingmember 580 thatsubstrate 515 is fixed to sidewall 520.Introduce the space of additional bone graft material and filling bone subsequently by the opening in thesubstrate 515 535.

With reference now to Figure 83,, the stability that provides thewedge 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 thewedge shape implant 545A that open the single component bottom.Equally, surgeon'sservice test implant 545A andtrial 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 theopening 535 ofbase side 515.

Equally, be used in thewedge 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 thespace 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 cutterorientation direction devices 705 andexcision guide 710700

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

Osteotomyorientation 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, showexcision guide 710 in furtherdetail.Excision guide 710 comprises the cuttinggroove 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 cutterorientation direction devices 705 and excision guide710) 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.

Extendiblewedge shape implant 805

With reference now to Figure 111-125,, in another preferred embodiment of the present invention, show and comprise and the extendiblewedge 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 twoopposite sides 810 that form open wedge osteotomy.

Extendiblewedge shape implant 805 comprises two opposite sides 810 (Figure 112), its surface constitute bone the space periphery and preferably in the periphery ofside 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 theside 810 each for along thehorizontal breach 825 of its length to form two opposite framing components 830,835.Withextendible material 840, the sheet of the flexibility of the material that biological example is compatible, the opposite framing component 830,835 of eachside 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 ofimplant 805 so that graft or filling material of bone are remained in theimplant opening 815.

Horizontal breach side 810 can be successive form (Figure 113) at leadingsection 845 places; Perhapsbreach side 810 can connect at leadingsection 845 places or combination (Figure 114); Perhapsbreach side 810 can connect (Figure 115) withextendible material 850 in the front end; Perhapsbreach side 810 can be leadingsection 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 securingmember base side 820 being attached to theend 860 of horizontal breach side 810.Substrate 820 preferably also comprises hole oropening 865, can cross by this hole oropening 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 theperiphery expansion implant 805 and theextendible material 840 of osteotomy.

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

With reference now to Figure 117,, any extendiblewedge 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.

Thebasal component 820 of extendiblewedge shape implant 805 is preferably by being inserted through substrate withbone screw 875 and entering the femur (not shown) or the bone of tibia 10 (Figure 118) provides fixing.Play fixed system by thebasal component 820 that allowsimplant 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 extendiblewedge shape implant 805 can provide the active compression of passing the osteotomy position by resorbentbasal component 820, promotes the higher rehabilitation of faster and intensity at osteotomy position thus.Equally, being used for fixing thebone screw 875 of basal component can be by forming withbasal component 820 same or analogous materials.

With reference now to Figure 119 and 120,, horizontal breach wedge-shapeddesign 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 onimplant 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 withfixation 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 ofimplants 805 andtibia 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 extendingimplant 805, and the withdrawal pipe 885 subsequently, allowmore implant 805 and new bone growth to integrate in binding agent that uses effective amount or cementmaterial 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) thechamber 900 of following the whole contact surface betweenimplant 805 and the bone in when using.Providing ofchamber 900 increases strength of fixation and safety.Similarly, after inserting and locatingimplant 805, adhesive material is injected/be transported in implant/bone hub cavity 900.Subsequently with screw or binding agentattachment 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 wedgeshape 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 definitesize.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 wedgeshape 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 (86)

Translated fromChinese

1.一种用于支持开放楔形切骨术的切骨术植入物，该切骨术植入物包括：1. An osteotomy implant for supporting an open wedge osteotomy, the osteotomy implant comprising:用于布置在开放楔形切骨术的后面的部分内的第一部件；a first component for placement within the posterior portion of the open wedge osteotomy;用于布置在开放楔形切骨术的前面的部分内的第二部件；及a second component for placement within the anterior portion of the open wedge osteotomy; and用于选择地将第一部件和第二部件连接到彼此的连接装置。Connection means for selectively connecting the first part and the second part to each other.2.根据权利要求1的切骨术植入物，其中，连接装置包括具有彼此相反的第一侧和第二侧的基底部件，其中，第一侧构造为用于选择地接附第一部件，并且其中，第二侧构造为用于选择地接附第二部件。2. The osteotomy implant according to claim 1, wherein the connecting means comprises a base member having a first side and a second side opposite to each other, wherein the first side is configured for selectively attaching the first member , and wherein the second side is configured for selective attachment of the second component.3.根据权利要求2的切骨术植入物，其中，基底部件在其中形成固定孔以便允许通过其中放置固定装置以将多个零件植入物锚定到胫骨。3. The osteotomy implant of claim 2, wherein the base member defines fixation holes therein to allow placement of a fixation device therethrough for anchoring the multi-part implant to the tibia.4.根据权利要求1的切骨术植入物，其中，连接装置包括在第一部件和第二部件之间的有槽的接头。4. The osteotomy implant according to claim 1, wherein the connecting means comprises a slotted joint between the first part and the second part.5.一种用于支持开放楔形切骨术的多个零件的切骨术植入物，该切骨术植入物包括：5. A multi-part osteotomy implant for supporting an open wedge osteotomy, the osteotomy implant comprising:用于布置在开放楔形切骨术的后面的部分内的第一部件；a first component for placement within the posterior portion of the open wedge osteotomy;用于布置在开放楔形切骨术的前面的部分内的第二部件；a second component for placement within the anterior portion of the open wedge osteotomy;用于布置在开放楔形切骨术的内侧的部分内的第三部件；a third component for placement within the portion medial to the open wedge osteotomy;用于选择地将第一部件连接到第三部件的第一连接机构；及a first connection mechanism for selectively connecting the first component to the third component; and用于选择地将第二部件连接到第三部件的第二连接机构。A second connection mechanism for selectively connecting the second component to the third component.6.根据权利要求5的多个零件的切骨术植入物，其中，第一连接机构包括形成在第一部件和第三部件之间的第一有槽的接头，并且其中，第二连接机构包括形成在第二部件和第三部件之间的第二有槽的接头。6. The multi-part osteotomy implant of claim 5, wherein the first connection mechanism comprises a first slotted joint formed between the first component and the third component, and wherein the second connection The mechanism includes a second slotted joint formed between the second member and the third member.7.根据权利要求6的切骨术植入物，其中，第一有槽的接头包括构造为接附到彼此的第一阳凸出和第一阴凹进处，并且进一步其中，第一阳凸出从第一部件和第三部件中的一个延伸，并且第一阴凹进处构造在第一部件和第三部件中的另一个内。7. The osteotomy implant according to claim 6, wherein the first grooved joint includes a first male protrusion and a first female recess configured to attach to each other, and further wherein the first male A protrusion extends from one of the first and third components, and a first female recess is formed in the other of the first and third components.8.根据权利要求7的切骨术植入物，其中，第一阳凸出从第三部件延伸，并且第一阴凹进处构造在第一部件内。8. The osteotomy implant of claim 7, wherein the first male projection extends from the third component and the first female recess is formed within the first component.9.根据权利要求6的多个零件的切骨术植入物，其中，第二有槽的接头包括构造为接附到彼此的第二阳凸出和第二阴凹进处，并且进一步其中，第二阳凸出从第二部件和第三部件中的一个延伸，并且第二阴凹进处构造在第二部件和第三部件中的另一个内。9. The multi-part osteotomy implant of claim 6, wherein the second grooved joint includes a second male protrusion and a second female recess configured to attach to each other, and further wherein , the second male protrusion extends from one of the second member and the third member, and the second female recess is formed in the other of the second member and the third member.10.根据权利要求9的多个零件的切骨术植入物，其中，第二阳凸出从第三部件延伸，并且第二阴凹进处构造在第二部件内。10. The multi-part osteotomy implant of claim 9, wherein the second male projection extends from the third component and the second female recess is formed within the second component.11.根据权利要求5的多个零件的切骨术植入物，其中，当连接在一起时，第一部件、第二部件和第三部件在其间形成空隙，并且其中，空隙大致对应开放楔形切骨术的中心区。11. The multi-part osteotomy implant of claim 5, wherein, when joined together, the first, second, and third components form a void therebetween, and wherein the void generally corresponds to an open wedge shape The central area of the osteotomy.12.根据权利要求11的多个零件的切骨术植入物，其中，第一部件、第二部件和第三部件构造为允许将移植物材料放置到空隙内。12. The multi-part osteotomy implant of claim 11, wherein the first component, the second component and the third component are configured to allow placement of graft material into the void.13.根据权利要求12的多个零件的切骨术植入物，其中，第一部件、第二部件和第三部件构造为允许移植物材料在空隙内压实。13. The multi-part osteotomy implant of claim 12, wherein the first component, the second component and the third component are configured to allow compaction of graft material within the void.14.根据权利要求5的多个零件的切骨术植入物，其中，第一部件包括具有第一组尺寸的第一壁，第二部件包括具有第二组尺寸的第二壁，并且进一步其中，第一部件的第一组尺寸和第二部件的第二组尺寸彼此不同，以便能够准确地布置AP胫骨斜面。14. The multi-part osteotomy implant of claim 5, wherein the first component comprises a first wall having a first set of dimensions, the second component comprises a second wall having a second set of dimensions, and further Wherein, the first set of dimensions of the first component and the second set of dimensions of the second component are different from each other to enable accurate placement of the AP tibial slope.15.根据权利要求5的多个零件的切骨术植入物，其中，第一部件具有第一表面和第二表面，第一表面构造为用于放置在切骨术空隙的口内并且第二表面构造为用于邻近开放楔形切骨术的骨表面放置，并且进一步其中，第一部件在第一表面和第二表面之间在其中形成第一通道，以便允许通过第一通道从第一表面到第二表面注入材料，并且将材料提供到形成在第一部件和骨之间的骨/植入物接口。15. The multi-part osteotomy implant of claim 5, wherein the first component has a first surface and a second surface, the first surface being configured for placement within the mouth of the osteotomy void and the second The surface is configured for placement adjacent to a bone surface of an open wedge osteotomy, and further wherein the first member forms a first channel therein between the first surface and the second surface, so as to allow passage from the first surface through the first channel Material is injected into the second surface and provided to a bone/implant interface formed between the first component and the bone.16.根据权利要求15的多个零件植入物，其中，第一部件在第一表面形成进入第一通道的第一注入口，并且进一步其中，第一注入口构造为在将第一部件邻近骨放置之后可被外科医生访问。16. The multi-part implant of claim 15, wherein the first component forms a first injection port at the first surface into the first channel, and further wherein the first injection port is configured to place the first component adjacent The bone is accessible to the surgeon after placement.17.根据权利要求16的多个零件植入物，其中，第一部件在第二表面形成多个出口。17. The multiple component implant of claim 16, wherein the first member forms a plurality of outlets at the second surface.18.根据权利要求15的切骨术植入物，其中，选择的材料包括从包括生物相容的粘合胶、骨接合剂、生物材料、生长因子、和移植材料的组中选择的至少一种。18. The osteotomy implant according to claim 15, wherein the selected material comprises at least one selected from the group consisting of biocompatible adhesives, bone cements, biomaterials, growth factors, and graft materials. kind.19.根据权利要求15的多个零件的切骨术植入物，其中，第二部件具有第三表面和第四表面，第三表面构造为用于放置切骨术空隙并且第四表面构造为用于邻近开放楔形切骨术的骨表面放置，并且进一步其中，第二部件在第三表面和第四表面之间在其中形成第二通道，以便允许通过第二通道从第三表面到第四表面注入材料，并且将材料提供到形成在第二部件和骨之间的骨/植入物接口。19. The multi-part osteotomy implant of claim 15, wherein the second component has a third surface and a fourth surface, the third surface being configured for placing an osteotomy void and the fourth surface being configured to For placement adjacent to a bone surface for an open wedge osteotomy, and further wherein the second member forms a second channel therein between the third surface and the fourth surface to allow passage from the third surface to the fourth surface through the second channel Material is surface injected and provided to a bone/implant interface formed between the second component and the bone.20.根据权利要求16的多个零件植入物，其中，第二部件在第三表面形成进入第二通道的第二注入口，并且进一步其中，第二注入口构造为在将第二部件邻近骨放置之后可被外科医生访问。20. The multi-part implant of claim 16, wherein the second component forms a second injection port at the third surface into the second channel, and further wherein the second injection port is configured to place the second component adjacent The bone is accessible to the surgeon after placement.21.根据权利要求20的多个零件植入物，其中，第二部件在第四表面形成多个出口。21. The multiple component implant of claim 20, wherein the second member forms a plurality of outlets at the fourth surface.22.根据权利要求19的多个零件植入物，其中，第二通道构造为允许注入从包括骨胶、接合剂、生物材料、和移植材料的组中选择的一种。22. The multiple part implant of claim 19, wherein the second channel is configured to allow injection of one selected from the group consisting of bone glue, cement, biomaterial, and graft material.23.根据权利要求5的多个零件植入物，其中，第一部件具有到骨内的第一再吸收速率，第二部件具有到骨内的第二再吸收速率，第三部件具有到骨内的第三再吸收速率，其中，第一再吸收速率和第二再吸收速率大致彼此相同，并且第三再吸收速率大致与第一再吸收速率和第二再吸收速率不同。23. The multiple-part implant of claim 5, wherein the first component has a first resorption rate into bone, the second component has a second resorption rate into bone, and the third component has a resorption rate into bone. A third resorption rate within , wherein the first resorption rate and the second resorption rate are approximately the same as each other, and the third resorption rate is approximately different from the first resorption rate and the second resorption rate.24.根据权利要求23的多个零件植入物，其中，第三部件在从包括以下方面的组中选择的至少一个方面与第一部件和第二部件不同：彼此不同的生物材料成分；彼此不同的生物复合物成分；和彼此不同的配方。24. The multiple part implant of claim 23, wherein the third component differs from the first and second components in at least one aspect selected from the group consisting of: different biomaterial compositions from each other; different biocomplex components; and different formulations from each other.25.根据权利要求5的多个零件植入物，其中，第三部件在其中形成第一固定孔以便允许第一固定装置通过其中放置以将多个零件植入物锚定到胫骨。25. The multi-piece implant of claim 5, wherein the third member forms a first fixation hole therein to allow placement of a first fixation device therethrough to anchor the multi-piece implant to the tibia.26.根据权利要求25的多个零件植入物，其中，第三部件在其中形成第二固定孔以便允许第二固定装置通过其中放置以将多个零件植入物锚定到胫骨。26. The multi-piece implant of claim 25, wherein the third member forms a second fixation hole therein to allow placement of a second fixation device therethrough to anchor the multi-piece implant to the tibia.27.根据权利要求26的多个零件植入物，其中，第一固定孔具有在第三部件上的进入部分和退出部分，第一固定孔限定了从第三部件的进入部分到退出部分的第一纵向轴线，第二固定孔具有在第三部件上的进入部分和退出部分，第二固定孔限定了从第三部件的进入部分到退出部分的第二纵向轴线，并且第一纵向轴线和第二纵向轴线不平行于彼此以便指引第一固定装置进入胫骨的第一部分并且指引第二固定装置进入胫骨的第二部分，使得胫骨的第一部分和胫骨的第二部分在第三部件的相反的侧上。27. The multiple-part implant of claim 26, wherein the first fixation hole has an entry portion and an exit portion on the third component, the first fixation hole defining a distance from the entry portion to the exit portion of the third component. The first longitudinal axis, the second fixing hole has an entry portion and an exit portion on the third component, the second fixing hole defines a second longitudinal axis from the entry portion to the exit portion of the third component, and the first longitudinal axis and The second longitudinal axis is not parallel to each other so as to guide the first fixation device into the first part of the tibia and to guide the second fixation device into the second part of the tibia, so that the first part of the tibia and the second part of the tibia are on opposite sides of the third component on the side.28.根据权利要求5的多个零件的切骨术植入物，其中，第一部件、第二部件和第三部件每个构造为用于在开放楔形切骨术的骨切口的内部与彼此组装在一起。28. The multi-part osteotomy implant of claim 5, wherein the first component, the second component, and the third component are each configured for contact with each other within a bone incision of an open wedge osteotomy Assemble together.29.根据权利要求5的多个零件的切骨术植入物，其中，第一部件、第二部件和第三部件每个构造为用于在开放楔形切骨术的骨切口的外部与彼此组装在一起。29. The multi-part osteotomy implant of claim 5, wherein the first component, the second component and the third component are each configured for contact with each other outside of the bone incision of the open wedge osteotomy. Assemble together.30.根据权利要求5的多个零件的切骨术植入物，其中，第一部件、第二部件和第三部件构造为从开放楔形切骨术的骨切口的前侧到后侧支撑开放楔形切骨术的骨切口。30. The multi-part osteotomy implant according to claim 5, wherein the first component, the second component and the third component are configured to support the open wedge from the anterior side to the posterior side of the bone incision of the open wedge osteotomy. Bone incision for wedge osteotomy.31.一种用于在胫骨内执行开放楔形切骨术的系统，该系统包括：31. A system for performing an open wedge osteotomy in a tibia, the system comprising:具有用于对准定位引导器的一部分与胫骨的关节线的对准部件和用于将定位引导器固定到胫骨的固定部件的定位引导器；a positioning guide having an alignment component for aligning a portion of the positioning guide with a joint line of the tibia and a fixation component for securing the positioning guide to the tibia;具有用于选择地将切割引导器接附到定位引导器的引导器接附部件的切割引导器，该切割引导器在其中形成构造为指引切割刀进入胫骨以便在胫骨内形成骨切口的有角度的切割槽；A cutting guide having a guide attachment member for selectively attaching the cutting guide to the positioning guide, the cutting guide having an angled hole formed therein configured to direct the cutting knife into the tibia to form a bone cut in the tibia cutting groove;具有用于选择地将千斤顶接附到定位引导器的千斤顶接附部件的机械千斤顶，该机械千斤顶具有一对具有彼此相反的第一端部和第二端部的板，该对板的第一端部构造为大致保持与彼此在一起并且构造为用于放置在胫骨内的骨切口内，并且该对板的第二端部构造为用于选择地定位(i)从该对板的第二端部大致与彼此在一起的第一位置，(ii)到该对板的第二端部彼此离开的第二位置，以便在骨切口处岔开胫骨；及A mechanical jack having a jack attachment member for selectively attaching the jack to a positioning guide, the mechanical jack has a pair of plates having first and second ends opposite to each other, the first of the pair of plates The ends are configured to be generally held together with each other and configured to be placed within the bone incision in the tibia, and the second end of the pair of plates is configured to selectively position (i) the second end of the pair of plates from the second end of the pair of plates. a first position where the ends are generally together with each other, (ii) to a second position where the second ends of the pair of plates are away from each other so as to distract the tibia at the bone incision; and用于在胫骨内支持开放楔形切骨术的多个零件植入物，该多个零件植入物具有用于布置在开放楔形切骨术的后面的部分内的第一部件、用于布置在开放楔形切骨术的前面的部分内的第二部件、和用于选择地将第一部件和第二部件连接到彼此的连接装置。A multiple-part implant for supporting an open wedge osteotomy in the tibia, the multiple-part implant having a first component for placement in a posterior portion of the open wedge osteotomy, for placement in A second component within the anterior portion of the open wedge osteotomy, and connecting means for selectively connecting the first and second components to each other.32.根据权利要求31的系统，其中，多个零件植入物在其中形成固定孔，并且还包括构造为用于通过多个零件植入物内的固定孔放置并且布置在胫骨内以便将多个零件植入物锚定到胫骨的固定装置。32. The system according to claim 31 , wherein the plurality of component implants form a fixation hole therein, and further comprising a plurality of component implants configured for placement through the fixation holes in the plurality of component implants and disposed within the tibia so as to place the plurality of component implants in the tibia. A fixation device that anchors the implant to the tibia.33.根据权利要求31的系统，其中，多个零件植入物的连接装置包括形成在第一部件和第二部件之间的有槽的接头。33. The system of claim 31, wherein the connecting means of the multiple part implant comprises a slotted joint formed between the first part and the second part.34.根据权利要求31的系统，其中，多个零件植入物的连接装置包括用于布置在第一部分和第二部件之间的基底部分，基底部分具有彼此相反的第一侧和第二侧，并且基底部分构造为用于选择地分别将第一部件和第二部件连接到其第一侧和第二侧，以便选择地用基底部分将第一部件和第二部件连接到彼此。34. The system according to claim 31 , wherein the connection means of the multiple part implant comprises a base portion for being disposed between the first portion and the second portion, the base portion having first and second sides opposite to each other , and the base portion is configured for selectively connecting the first component and the second component to the first side and the second side thereof, respectively, so as to selectively connect the first component and the second component to each other with the base portion.35.一种用于在胫骨内执行开放楔形切骨术的系统，该系统包括：35. A system for performing an open wedge osteotomy in a tibia, the system comprising:具有用于选择地将切割引导器接附到胫骨的引导器接附部件的切割引导器，该切割引导器在其中形成构造为指引切割刀进入胫骨以便在胫骨内形成骨切口的有角度的切割槽；A cutting guide having a guide attachment member for selectively attaching the cutting guide to the tibia, the cutting guide forming therein an angled cut configured to direct the cutting knife into the tibia to form a bone cut in the tibia groove;具有一对具有彼此相反的第一端部和第二端部的板的机械千斤顶，该对板的第一端部构造为大致保持与彼此在一起并且构造为用于放置在胫骨内的骨切口内，并且该对板的第二端部构造为用于选择地定位(i)从该对板的第二端部大致与彼此在一起的第一位置，到(ii)该对板的第二端部彼此离开的第二位置，以便在骨切口处岔开胫骨；及A mechanical jack having a pair of plates having opposite first and second ends, the first ends of the pair of plates being configured to generally remain with each other and configured for placement in a bone cutout in the tibia and the second ends of the pair of plates are configured for selectively positioning (i) from a first position where the second ends of the pair of plates are generally together with each other, to (ii) a second end of the pair of plates a second position where the ends are spaced apart from each other so as to diverge the tibia at the bony incision; and用于在胫骨内支持开放楔形切骨术的多个零件植入物，该多个零件植入物具有用于布置在开放楔形切骨术的后面的部分内的第一部件、用于布置在开放楔形切骨术的前面的部分内的第二部件、和用于选择地将第一部件和第二部件连接到彼此的连接装置。A multiple-part implant for supporting an open wedge osteotomy in the tibia, the multiple-part implant having a first component for placement in a posterior portion of the open wedge osteotomy, for placement in A second component within the anterior portion of the open wedge osteotomy, and connecting means for selectively connecting the first and second components to each other.36.一种用于支持开放楔形切骨术的切骨术植入物，该切骨术植入物包括：36. An osteotomy implant for supporting an open wedge osteotomy, the osteotomy implant comprising:具有第一高度、第一宽度的前边缘，并且第一高度构造为用于放置在开放楔形切骨术的远侧的部分内；an anterior edge having a first height, a first width, and the first height configured for placement within a distal portion of an open wedge osteotomy;与前边缘相反的基底部分，基底部分具有第二高度、第二宽度，并且第二高度构造为大致闭合开放楔形切骨术的近侧的端部；及a base portion opposite the anterior edge, the base portion having a second height, a second width, and the second height configured to substantially close the proximal end of the open wedge osteotomy; and将前边缘连接到基底部分的两个相反的侧壁，相反的侧壁具有与从前边缘到基底部分的距离相等的第一长度，并且相反的侧壁具有从前边缘的第一高度到基底部分的第二高度渐缩的高度。Connecting the front edge to two opposite side walls of the base portion, the opposite side walls have a first length equal to the distance from the front edge to the base portion, and the opposite side walls have a first height from the front edge to the base portion The height of the second height taper.37.根据权利要求36的切骨术植入物，还包括在两个相反的侧壁之间延伸并且从基底部分延伸到前边缘的底板部分，并且其中，底板部分具有第三高度，并且基底部分的第一高度大于底板部分的第三高度，以便在两个相反的侧之间形成打开部分。37. The osteotomy implant according to claim 36, further comprising a floor portion extending between two opposite side walls and extending from the base portion to the front edge, and wherein the floor portion has a third height, and the base portion The first height of the portion is greater than the third height of the floor portion so as to form an open portion between two opposite sides.38.根据权利要求36的切骨术植入物，其中，基底部分形成至少一个用于通过其中插入材料的通过其中的开口。38. The osteotomy implant according to claim 36, wherein the base portion defines at least one opening therethrough for insertion of material therethrough.39.根据权利要求38的切骨术植入物，其中，材料为从包括同种异体移植物骨；自体移植物骨；去除矿物质的骨代替物；骨移植物材料；和骨接合剂的组中选择的至少一种。39. The osteotomy implant according to claim 38, wherein the material is derived from bone comprising allograft; autograft bone; demineralized bone substitute; bone graft material; and bone cement At least one selected from the group.40.根据权利要求36的切骨术植入物，其中，两个相反的侧大致与彼此平行。40. The osteotomy implant of claim 36, wherein the two opposing sides are generally parallel to each other.41.根据权利要求36的切骨术植入物，还包括从两个相反的侧壁的骨接口表面延伸的一系列凸出，其中，该凸出构造为允许相反的侧壁插入开放楔形切骨术内并且防止相反的侧壁移动出开放楔形切骨术。41. The osteotomy implant according to claim 36, further comprising a series of protrusions extending from the bone interface surfaces of the two opposing side walls, wherein the protrusions are configured to allow insertion of the opposing side walls into the open wedge incision. within the osteotomy and prevent the opposite lateral wall from moving out of the open wedge osteotomy.42.根据权利要求36的切骨术植入物，其中，两个相反的侧壁在其中限定了用于通过其中输送选择的材料的通道。42. The osteotomy implant of claim 36, wherein the two opposing side walls define a channel therein for delivery of a selected material therethrough.43.根据权利要求42的切骨术植入物，还包括输送装置，该输送装置包括具有长度和直径的管，该管沿其长度形成一系列开口，该直径构造为用于放置在通道的主要的部分内，并且该系列开口构造为对应通道的一系列分支部分。43. The osteotomy implant according to claim 42, further comprising a delivery device comprising a tube having a length and a diameter forming a series of openings along its length, the diameter being configured for placement in the channel within the main portion, and the series of openings are configured as a series of branching portions corresponding to the channel.44.根据权利要求36的切骨术植入物，其中，两个相反的侧壁在其骨接口表面上限定通道开口以便允许选择的材料通过其中输送。44. The osteotomy implant according to claim 36, wherein the two opposing side walls define a channel opening on the bone interface surface thereof to allow delivery of selected material therethrough.45.根据权利要求44的切骨术植入物，其中，选择的材料包括从包括生物相容的粘合胶；骨接合剂；生长因子；和移植材料的组中选择的至少一种。45. The osteotomy implant according to claim 44, wherein the selected material comprises at least one selected from the group consisting of biocompatible adhesive glue; bone cement; growth factors; and graft material.46.一种用于支持开放楔形切骨术的切骨术植入物，该切骨术植入物包括：46. An osteotomy implant for supporting an open wedge osteotomy, the osteotomy implant comprising:具有第一高度、第一端部和第二端部、第一端部和第二端部之间的宽度的基底部分，第一高度构造为大致闭合开放楔形切骨术的近侧的端部；a base portion having a first height, a first end and a second end, a width between the first end and the second end, the first height being configured to substantially close the proximal end of the open wedge osteotomy ;分别从第一端部和第二端部延伸的两个相反的侧壁，两个相反的侧壁具有第三端部和第四端部，第三端部从基底部分延伸，第二高度等于在第三端部处的基底部分的第一高度，在第四端部处的两个相反的侧壁中的每个具有第三高度，第三高度小于第二高度以便允许将两个相反的侧壁中的每个的第四端部放置在开放楔形切骨术的远侧的部分内。Two opposite side walls extending from the first end and the second end respectively, the two opposite side walls have a third end and a fourth end, the third end extends from the base portion, the second height is equal to At the first height of the base portion at the third end, each of the two opposing side walls at the fourth end has a third height, the third height being less than the second height to allow the two opposing The fourth end of each of the side walls is placed within the distal portion of the open wedge osteotomy.47.根据权利要求46的切骨术植入物，其中，两个相反的壁大致与彼此平行。47. The osteotomy implant according to claim 46, wherein the two opposing walls are generally parallel to each other.48.根据权利要求46的切骨术植入物，其中，两个相反的侧壁分别在相反的侧壁中的每一个的第三端部和第四端部之间的区内接近彼此。48. The osteotomy implant according to claim 46, wherein the two opposing side walls approach each other in a region between the third end and the fourth end, respectively, of each of the opposing side walls.49.根据权利要求46的切骨术植入物，其中，基底部分形成至少一个用于通过其中插入材料的通过其中的开口。49. The osteotomy implant according to claim 46, wherein the base portion defines at least one opening therethrough for insertion of material therethrough.50.根据权利要求46的切骨术植入物，其中，材料为从包括同种异体移植物骨；自体移植物骨；去除矿物质的骨代替物；骨移植物材料；和骨接合剂的组中选择的至少一种。50. The osteotomy implant according to claim 46, wherein the material is derived from bone comprising allograft; autograft bone; demineralized bone substitute; bone graft material; and bone cement At least one selected from the group.51.根据权利要求46的切骨术植入物，还包括在两个相反的侧壁之间分别从侧壁中的每一个的第三端部和第四端部之间的位置延伸的连接器。51. The osteotomy implant according to claim 46, further comprising a connection extending between the two opposing side walls from a location between the third end and the fourth end of each of the side walls, respectively device.52.根据权利要求46的切骨术植入物，其中，两个侧壁可以选择地从彼此分开。52. The osteotomy implant of claim 46, wherein the two side walls are selectively separable from each other.53.根据权利要求52的切骨术植入物，其中，基底部分可以选择的从两个侧壁分开。53. The osteotomy implant according to claim 52, wherein the base portion is selectively separable from the two side walls.54.根据权利要求53的切骨术植入物，其中，选择的材料包括从包括生物相容的粘合胶；骨接合剂；生长因子；和移植材料的组中选择的至少一种。54. The osteotomy implant according to claim 53, wherein the selected material comprises at least one selected from the group consisting of biocompatible adhesive glue; bone cement; growth factors; and graft material.55.根据权利要求52的切骨术植入物，还包括从两个相反的侧壁的骨接口表面延伸的一系列凸出，其中，该凸出构造为允许相反的侧壁插入开放楔形切骨术内并且防止相反的侧壁移动出开放楔形切骨术。55. The osteotomy implant according to claim 52, further comprising a series of protrusions extending from the bone interface surfaces of the two opposing side walls, wherein the protrusions are configured to allow insertion of the opposing side walls into the open wedge incision. within the osteotomy and prevent the opposite lateral wall from moving out of the open wedge osteotomy.56.根据权利要求46的切骨术植入物，其中，两个相反的侧壁在其中限定了用于通过其中输送选择的材料的通道。56. The osteotomy implant of claim 46, wherein the two opposing side walls define a channel therein for delivery of the selected material therethrough.57.根据权利要求56的切骨术植入物，其中，选择的材料包括从包括生物相容的粘合胶；骨接合剂；生长因子；和移植材料的组中选择的至少一种。57. The osteotomy implant according to claim 56, wherein the selected material comprises at least one selected from the group consisting of biocompatible adhesive glue; bone cement; growth factors; and graft material.58.根据权利要求56的切骨术植入物，还包括输送装置，该输送装置包括具有长度和直径的管，该管沿其长度形成一系列开口，该直径构造为用于放置在通道的主要的部分内，并且该系列开口构造为对应通道的一系列分支部分。58. The osteotomy implant according to claim 56, further comprising a delivery device comprising a tube having a length and a diameter forming a series of openings along its length, the diameter being configured for placement in the channel within the main portion, and the series of openings are configured as a series of branching portions corresponding to the channel.59.根据权利要求46的切骨术植入物，其中，两个相反的侧壁在其骨接口表面上限定了通道以便允许选择的材料在其中输送。59. The osteotomy implant of claim 46, wherein the two opposing side walls define a channel on the bone interface surface thereof to allow delivery of selected materials therethrough.60.根据权利要求59的切骨术植入物，其中，选择的材料包括从包括生物相容的粘合胶；骨接合剂；生长因子；和移植材料的组中选择的至少一种。60. The osteotomy implant according to claim 59, wherein the selected material comprises at least one selected from the group consisting of biocompatible adhesive glue; bone cement; growth factors; and graft material.61.一种用于支持开放楔形切骨术的切骨术植入物，该切骨术植入物包括：61. An osteotomy implant for supporting an open wedge osteotomy, the osteotomy implant comprising:具有彼此相反的第一端部和第二端部的两个相反的侧壁，在两个相反的侧壁中的每个的第一端部和第二端部之间延伸的一对框架构件，布置在两个相反的侧壁中的每个的该对框架构件之间的可扩展的材料，该对框架构件在其第一端部彼此连接，并且该对框架构件在其第二端部可以选择地彼此分开到选择的高度；Two opposing side walls having first and second ends opposite each other, a pair of frame members extending between the first and second ends of each of the two opposing side walls , an expandable material disposed between the pair of frame members of each of the two opposing side walls, the pair of frame members being connected to each other at their first ends, and the pair of frame members at their second ends can optionally be separated from each other to a chosen height;具有给定的高度和给定的宽度的基底构件，其中，给定的高度大致等于两个相反的侧壁中的每个的该对框架构件的选择的高度，并且其中，给定的宽度大致等于当被放置在开放楔形切骨术内时两个相反的侧壁之间的距离；及A base member having a given height and a given width, wherein the given height is approximately equal to the selected height of the pair of frame members of each of the two opposing side walls, and wherein the given width is approximately equal to the distance between the two opposing lateral walls when placed within an open wedge osteotomy; and用于将基底构件连接到两个相反的侧壁中的每个的一组连接器。A set of connectors for connecting the base member to each of the two opposing side walls.62.根据权利要求61的切骨术植入物，其中，基底构件在其中限定了用于该组连接器通过其中布置以将基底构件连接到两个相反的侧中的每个的通路。62. The osteotomy implant of claim 61, wherein the base member defines a passage therethrough for the set of connectors to be disposed therethrough to connect the base member to each of the two opposing sides.63.根据权利要求61的切骨术植入物，其中，从包括基底部分和两个相反的侧壁的组中选择的至少一个限定了通过其中的开口，并且该开口构造为用于在两个相反的侧部分之间将选择的材料插入开放楔形切骨术。63. The osteotomy implant according to claim 61, wherein at least one selected from the group comprising a base portion and two opposite side walls defines an opening therethrough, and the opening is configured for Insert the material of choice into the open wedge osteotomy between the two opposing lateral segments.64.根据权利要求63的切骨术植入物，其中，选择的材料包括从包括生物相容的粘合胶；骨接合剂；生长因子；和移植材料的组中选择的至少一种。64. The osteotomy implant according to claim 63, wherein the selected material comprises at least one selected from the group consisting of biocompatible adhesive glue; bone cement; growth factors; and graft material.65.根据权利要求61的切骨术植入物，还包括从两个相反的侧壁的骨接口表面延伸的一系列凸出，其中，该凸出构造为允许相反的侧壁插入开放楔形切骨术内并且防止相反的侧壁移动出开放楔形切骨术。65. The osteotomy implant according to claim 61, further comprising a series of protrusions extending from the bone interface surfaces of the two opposing side walls, wherein the protrusions are configured to allow insertion of the opposing side walls into the open wedge incision. within the osteotomy and prevent the opposite lateral wall from moving out of the open wedge osteotomy.66.根据权利要求61的切骨术植入物，还包括用于在第二端部打开两个相反的侧壁中的每个的开放楔形板装置，该开放楔形板具有构造为用于接附到两个相反的侧壁中的每个的该对框架构件中的每个的四个接附点，和两个用于接附到千斤顶机构的连接器，其中，开放楔形板装置构造为在侧壁中的每个的第二端部相对于彼此扩展时支撑两个相反的侧壁。66. The osteotomy implant according to claim 61 , further comprising an opening wedge means for opening each of the two opposite side walls at the second end, the opening wedge having a configuration for receiving Four attachment points for each of the pair of frame members attached to each of the two opposing side walls, and two connectors for attachment to a jack mechanism, wherein the open wedge arrangement is configured as Two opposing side walls are supported as the second end of each of the side walls expands relative to each other.67.一种用于支持开放楔形切骨术的多个零件的切骨术植入物，该切骨术植入物包括：67. A multi-part osteotomy implant for supporting an open wedge osteotomy, the osteotomy implant comprising:构造为用于布置在开放楔形切骨术的后面的部分内的第一部件；及a first component configured for placement within a posterior portion of an open wedge osteotomy; and构造为用于布置在开放楔形切骨术的前面的部分内的第二部件；a second component configured for placement within the anterior portion of the open wedge osteotomy;其中，当布置在开放楔形切骨术内时，第一部件和第二部件形成U形壁。Wherein, the first part and the second part form a U-shaped wall when arranged within an open wedge osteotomy.68.根据权利要求67的多个零件的切骨术植入物，其中，第一部件和第二部件构造为用于在开放楔形切骨术内邻近彼此布置以便接触彼此。68. The multi-part osteotomy implant of claim 67, wherein the first component and the second component are configured for placement adjacent one another within an open wedge osteotomy so as to contact one another.69.根据权利要求68的多个零件的切骨术植入物，其中，第一部件和第二部件构造为用于在开放楔形切骨术内不与彼此连接地布置。69. The multi-part osteotomy implant of claim 68, wherein the first component and the second component are configured for non-attached arrangement with each other within an open wedge osteotomy.70.根据权利要求67的多个零件的切骨术植入物，其中，第一部件和第二部件构造为用于在开放楔形切骨术内不与彼此连接地布置。70. The multi-part osteotomy implant of claim 67, wherein the first component and the second component are configured for non-attached arrangement with each other within an open wedge osteotomy.71.根据权利要求67的多个零件的切骨术植入物，还包括构造为用于布置在开放楔形切骨术的内侧的部分内的第三部件，其中，当布置在开放楔形切骨术内时，第一部件、第二部件和第三部件形成U形壁。71. The multi-part osteotomy implant of claim 67, further comprising a third component configured for placement in a portion inside the open wedge osteotomy, wherein when placed in the open wedge osteotomy Intraoperatively, the first component, the second component and the third component form a U-shaped wall.72.根据权利要求71的多个零件的切骨术植入物，其中，第一部件和第二部件构造为用于在开放楔形切骨术内邻近彼此布置以便接触彼此，并且第二部件和第三部件构造为用于在开放楔形切骨术内邻近彼此布置以便接触彼此。72. The multi-part osteotomy implant of claim 71 , wherein the first component and the second component are configured for being disposed adjacent to each other within an open wedge osteotomy so as to contact each other, and the second component and the second component The third components are configured for placement adjacent to each other so as to contact each other within the open wedge osteotomy.73.根据权利要求72的多个零件的切骨术植入物，其中，第一部件和第二部件构造为用于在不直接接触彼此的情况下布置在开放楔形切骨术内。73. The multi-part osteotomy implant of claim 72, wherein the first component and the second component are configured for placement within an open wedge osteotomy without directly contacting each other.74.一种用于支持开放楔形切骨术的切骨术植入物，该切骨术植入物包括：74. An osteotomy implant for supporting an open wedge osteotomy, the osteotomy implant comprising:构造为用于布置在开放楔形切骨术内的U形壁，形成在壁的凹入侧上的内部部分，和形成在壁的凸出侧上的外部部分；及a U-shaped wall configured for placement within an open wedge osteotomy, an inner portion formed on a concave side of the wall, and an outer portion formed on a convex side of the wall; andU形壁形成从外部部分进入内部部分的通过其中的访问口，其中，访问口允许材料在外部部分和内部部分之间通过。The U-shaped wall forms an access port therethrough from the outer part into the inner part, wherein the access port allows material to pass between the outer part and the inner part.75.根据权利要求74的切骨术植入物，其中，当切骨术植入物布置在开放楔形切骨术内时，访问口构造在U形壁的内侧的部分内。75. The osteotomy implant according to claim 74, wherein the access port is configured in a portion of the inner side of the U-shaped wall when the osteotomy implant is disposed within the open wedge osteotomy.76.根据权利要求74的切骨术植入物，其中，当切骨术植入物布置在开放楔形切骨术内时，访问口构造在U形壁的后面的部分内。76. The osteotomy implant according to claim 74, wherein when the osteotomy implant is placed in the open wedge osteotomy, the access port is configured in the rear portion of the U-shaped wall.77.根据权利要求74的切骨术植入物，其中，当切骨术植入物布置在开放楔形切骨术内时，访问口构造在U形壁的前面的部分内。77. The osteotomy implant according to claim 74, wherein when the osteotomy implant is placed in the open wedge osteotomy, the access port is configured in the front portion of the U-shaped wall.78.根据权利要求74的切骨术植入物，其中，U形壁形成从外部的部分进入内部的部分的通过其中的附加的访问口。78. The osteotomy implant according to claim 74, wherein the U-shaped wall forms an additional access port therethrough from the outer portion into the inner portion.79.根据权利要求78的切骨术植入物，其中，访问口和附加的访问口中的一个构造为当通过访问口和附加的访问口中的另一个注入材料时，允许材料溢出以从内部的部分退出。79. The osteotomy implant according to claim 78, wherein one of the access port and the additional access port is configured to allow material to overflow from the interior when injecting material through the other of the access port and the additional access port. Partially withdrawn.80.一种用于支持开放楔形切骨术的多个零件的切骨术植入物，该切骨术植入物包括：80. A multi-part osteotomy implant for supporting an open wedge osteotomy, the osteotomy implant comprising:构造为用于布置在开放楔形切骨术的后面的部分内的第一部件；及a first component configured for placement within a posterior portion of an open wedge osteotomy; and构造为用于布置在开放楔形切骨术的前面的部分内的第二部件；a second component configured for placement within the anterior portion of the open wedge osteotomy;其中，第一部件包括第一材料，第二部件包括第二材料，并且第一材料和第二材料彼此不同。Wherein, the first component includes a first material, the second component includes a second material, and the first material and the second material are different from each other.81.根据权利要求80的多个零件植入物，其中，第一部件和第二部件构造为用于在开放楔形切骨术内邻近彼此布置以便接触彼此。81. The multi-part implant of claim 80, wherein the first component and the second component are configured for placement adjacent one another within an open wedge osteotomy so as to contact one another.82.根据权利要求81的多个零件植入物，其中，当布置在开放楔形切骨术内时，第一部件和第二部件形成U形壁。82. The multiple part implant of claim 81, wherein the first and second components form a U-shaped wall when disposed within an open wedge osteotomy.83.根据权利要求80的多个零件植入物，还包括构造为用于布置在开放楔形组件的内侧的部分内的第三部件，其中，第三部件包括第三材料，并且进一步其中，第一材料、第二材料、和第三材料与彼此不同。83. The multi-part implant of claim 80, further comprising a third component configured for placement within a portion of the inside of the open wedge assembly, wherein the third component comprises a third material, and further wherein the first The first material, the second material, and the third material are different from each other.84.一种用于支持开放楔形切骨术的多个零件植入物，该切骨术植入物包括：84. A multi-part implant for supporting an open wedge osteotomy, the osteotomy implant comprising:构造为用于布置在开放楔形切骨术的后面的部分内的第一部件；a first component configured for placement within a posterior portion of an open wedge osteotomy;构造为用于布置在开放楔形切骨术的前面的部分内的第二部件；a second component configured for placement within the anterior portion of the open wedge osteotomy;构造为用于布置在开放楔形切骨术的内侧的部分内的第三部件；并且a third component configured for placement within the medial portion of the open wedge osteotomy; and其中，第一部件包括第一材料，第二部件包括第二材料，第三部件包括第三材料，并且从由第一材料、第二材料、和第三材料组成的组中选择的一种与从由第一材料、第二材料、和第三材料组成的组中选择的另一种不同。Wherein, the first component comprises a first material, the second component comprises a second material, the third component comprises a third material, and one selected from the group consisting of the first material, the second material, and the third material is compatible with Another difference selected from the group consisting of the first material, the second material, and the third material.85.根据权利要求84的多个零件植入物，其中，第三材料与第一材料和第二材料不同。85. The multiple component implant of claim 84, wherein the third material is different from the first material and the second material.86.根据权利要求84的多个零件植入物，其中，第一材料、第二材料和第三材料中的每个与彼此不同。86. The multiple component implant of claim 84, wherein each of the first material, the second material, and the third material are different from each other.

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