(19)
(11)EP 3 304 380 B1

(12)EUROPEAN PATENT SPECIFICATION

(45)Mention of the grant of the patent:
20.05.2020 Bulletin 2020/21

(21)Application number: 16800825.8

(22)Date of filing:  27.05.2016
(51)International Patent Classification (IPC): 
A61B 5/00(2006.01)
A61B 17/16(2006.01)
A61F 2/46(2006.01)
A61B 5/107(2006.01)
A61F 2/30(2006.01)
(86)International application number:
PCT/US2016/034776
(87)International publication number:
WO 2016/191725 (01.12.2016 Gazette  2016/48)

(54)

PATIENT-SPECIFIC BONE GRAFTING SYSTEM

PATIENTENSPEZIFISCHES KNOCHENTRANSPLANTATSYSTEM

SYSTÈME DE GREFFE OSSEUSE SPÉCIFIQUE AU PATIENT


(84)Designated Contracting States:
AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

(30)Priority: 28.05.2015 US 201562167686 P

(43)Date of publication of application:
11.04.2018 Bulletin 2018/15

(73)Proprietor: Zimmer, Inc.
Warsaw, Indiana 46581-0708 (US)

(72)Inventors:
  • GUILLOUX, Sebastien
    69800 Sanit-Priest (FR)
  • BOISVERT, Olivier
    Montreal, QC H3C 2N6 (CA)
  • DUPUIS, Karine
    Montreal, QC H2E 2R8 (CA)
  • NEUROHR, Anselm
    Montreal, QC H2W 2B7 (CA)
  • ABIVEN, Jean-Guillaume
    Montreal, QC H3L 1B3 (CA)

(74)Representative: Taor, Simon Edward William et al
Venner Shipley LLP 200 Aldersgate
London EC1A 4HD
London EC1A 4HD (GB)


(56)References cited: : 
WO-A1-2013/177389
US-A- 5 722 977
US-A1- 2009 209 962
US-A1- 2013 191 085
US-A1- 2014 343 554
WO-A1-2014/188369
US-A1- 2002 082 604
US-A1- 2010 087 927
US-A1- 2013 296 872
  
      
    Note: Within nine months from the publication of the mention of the grant of the European patent, any person may give notice to the European Patent Office of opposition to the European patent granted. Notice of opposition shall be filed in a written reasoned statement. It shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention).


    Description

    TECHNICAL FIELD



    [0001] The present application relates to orthopedic shoulder surgery and more particularly to patient-specific instrumentation used to harvest bone grant and implant same. For example, the system and method may be applied to reverse shoulder arthroplasty, featuring humeral bone graft for eroded glenoids.

    BACKGROUND OF THE ART



    [0002] Bone grafts are occasionally used in orthopedic surgery. Bone grafts are used to fill gaps between a recipient bone and an implant. Bone autografts have the ability to be osteoinductive, osteogenic, and/or osteoconductive and therefore are an advantageous choice for orthopedic surgery, to interface off-the-shelf implants to bone. Allografts are also commonly used.

    [0003] For example, in reverse shoulder arthroplasty, the shoulder joint involves implants that replicate the native shoulder joint, but in a reverse arrangement with the scapula forming the joint head, and the humerus forming the socket. Reverse shoulder arthroplasty is often used because of glenoid deformities and/or rotators cuff malfunction. Considering that the humerus must be machined and converted into a socket, there is a source of graft that can be used to correct glenoid deformities, and/or to create an interface between an implant and the glenoid. Humerus bone grafts may be harvested to compensate the bone loss due to glenoid erosion. As subchondral bone has been shown to be effective in stabilizing glenoid implants more than cancellous bone, it is desirable to harvest grafts in the humerus.

    [0004] However, grafting techniques involving for example autografts commonly involve some graft adaptation steps, e.g., machining, alterations, for the graft to have a desired geometry for subsequent implantation. However, such machining steps may add time to a suraical procedure.

    [0005] WO 2014/188369 A1 describes a system for generating a model of a patient specific cut guide instrument for harvesting a graft, comprising: a patient-specific instrument generator for outputting the model of the patient specific cut guide instrument, the patient-specific instrument generator including: a position determination module for orienting and positioning at least a first guide axis, and for positioning an abutment on a model of a donor bone, and an instrument body generator module for generating a model of the patient specific cut guide instrument comprising a body supporting a cut guide to perform a depth cut in the donor bone positioned and oriented as a function of a contact of the body with an abutment on the donor bone, and of the model of the graft, a first guide portion for alignment with the first guide axis, and at least one anchor guide for securing the patient specific instrument cut guide on the donor bone as abutted with the abutment and aligned with the first guide axis.

    SUMMARY



    [0006] The present invention relates to a system, as defined in claim 1, for generating a model of a patient specific cutting guide instrument for harvesting a graft. Preferred embodiments of the invention are defined in the dependent claims.

    DESCRIPTION OF THE DRAWINGS



    [0007] 

    Fig. 1 is a perspective view of a humerus grafting patient-specific instrument in accordance with a first example;

    Fig. 2 is a schematic side view of the humerus grafting patient-specific instrument of Fig. 1;

    Fig. 3 is a transverse view showing a planned positioning of a glenoid implant relative to a scapula;

    Fig. 4 is the transverse view of Fig. 3, with a humerus graft positioned between the glenoid implant and the reamed glenoid;

    Fig. 5 is a frontal view of a glenoid implant relative to a scapula in another embodiment;

    Fig. 6 is a frontal view of the glenoid implant and scapula of Fig. 5, with a humerus graft in the reamed glenoid;

    Fig. 7 is a schematic view demonstrating a humerus with a guide rod;

    Fig. 8 is a schematic view of the humerus of Fig. 7, with a reamer on the guide rod;

    Fig. 9 is a perspective view of the humerus of Fig. 8, with the humerus grafting patient-specific instrument of Fig. 1 being slid on the guide rod;

    Fig. 10 is a perspective view of the humerus of Fig. 9, with the humerus grafting patient-specific instrument being pinned to the humerus;

    Fig. 11 is a perspective view of the humerus of Fig. 10, with a cut blade guided by the humerus grafting patient-specific instrument of Fig. 1;

    Fig. 12 is a schematic side view of the humerus of Fig. 7, with a depth cut;

    Fig. 13 is a schematic view of the humerus of Fig. 12, with a bell saw on the guide rod;

    Fig. 14 is a schematic view of the humerus of Fig. 13, with lateral cuts;

    Fig. 15 is a schematic view of the humerus of Fig. 14, with the glenoid implant inserted into a graft for removal;

    Fig. 16 is a schematic view of the humerus of Fig. 16 with the humerus graft being harvested with the glenoid implant;

    Fig. 17 is a perspective view of a humerus grafting patient specific instrument in accordance with a second example;

    Fig. 18 is a side view of a glenoid implant relative to a glenoid cavity in accordance with the second example;

    Fig. 19 is a perspective view of the humerus with a hemispherical reamer;

    Fig. 20 is a perspective view of the humerus of Fig. 19, with the humerus grafting patient-specific instrument of Fig. 17;

    Fig. 21 is a perspective view of the humerus of Fig. 20, with a cut blade used with the humerus grafting patient-specific instrument of Fig. 17;

    Fig. 22 is a perspective view of the humerus of Fig. 21, with a guide pin being repositioned;

    Fig. 23 is a perspective view of the humerus of Fig. 22, with a depth cut thereon;

    Fig. 24 is a perspective view of the humerus of Fig. 23, with a saw bell;

    Fig. 25 is a perspective view of a patient-specific barrel with a harvested humerus graft;

    Fig. 26 is a perspective view of the patient-specific barrel with impactor, glenoid implant and graft;

    Fig. 27 is a side view of an impactor relative to the glenoid cavity in the process of implanting the glenoid implant and graft;

    Fig. 28 is a side view of a reamer reaming the glenoid cavity for receiving the humerus graft harvested in Figs. 17 to 24;

    Fig. 29 is a side view of the humerus graft, glenoid implant in the resurfaced glenoid cavity; and

    Fig. 30 is a block diagram of a system for generating a model of a patient specific cut guide instrument for harvesting a graft, in accordance with the present disclosure.


    DETAILED DESCRIPTION



    [0008] Referring to the drawings, methods for harvesting a graft is generally shown. The illustrated methods show the harvesting of a graft on the humerus in a reverse shoulder arthroplasty, for example in an autograft or allograft situation (including a cadaver allograft). However, the methods may apply to other bones as well, for example using the iliac crest as a donor bone. For simplicity, the examples of the present disclosure focus on a reverse shoulder arthroplasty with the humerus as donor bone, although other bones could be used in accordance with the present disclosure.

    [0009] In Fig. 1, a humerus grafting patient-specific instrument is generally shown at 10. The humerus grafting patient-specific instrument 10 is said to be patient-specific, in that its geometry is modeled based on a planning for every patient's unique anatomy, using imaging techniques. Stated differently, the humerus grafting patient-specific instrument 10 is developed subsequent to pre-operative steps by which a patient's anatomy is modeled and the implant position is defined. Hence, the humerus grafting patient-specific instrument 10 has an identity related to a patient, and is most likely inadequate for being used with other patients, whereby the instrument 10 is typically a one-time use instrument. Accordingly, the humerus grafting patient-specific instrument 10 has a model file 11 of non-transient format which features a two-dimensional or three-dimensional model of the patient's anatomy resulting from pre-operative imaging. The specific geometry of the components of the humerus grafting patient-specific instrument 10 are directly related to the contents of the model file 11.

    [0010] The humerus grafting patient-specific instruments of the present disclosure are designed to carve out a graft in the native humerus (e.g., especially in autograft procedure, but also in allograft), which humerus graft will be used as an interface between a glenoid cavity and an implant. The humerus is therefore in this example the donor bone, whereas the scapula is the receiver bone. Accordingly, the model file 11 may define a specific spatial geometry for the humerus graft, featuring a glenoid interface surface that will lie against the reamed glenoid, an implant interface surface against which an undersurface of the implant will lie, and lateral wall(s) between the glenoid interface surface and the implant interface surface. The humerus grafting patient-specific instruments and methods described herein are such that little or no machining steps are required on the humeral graft once harvested. Indeed, some prior art techniques suggest removing a voluminous humeral graft, to then suggest the machining of the graft prior to grafting. The PSI technique taught herein allows the surgeon to plan the implant position with a graft, while execution is intraoperative.

    [0011] Referring to Fig. 1, the instrument 10 is shown as having a base plate 12. The base plate 12 is shown as being generally circular (i.e., disc-shaped) but other shapes are considered as well. A guide bore 13 is provided through the base plate 12 and will be used as described hereinafter as a guide for translational/rotational movements. One or more depths legs 14 project from the base plate 12 and support a cut slot 15 - with pin guides 15A - at ends opposite to the base plate 12. The cut slot 15 is configured to receive a cut blade therein. As shown in Fig. 2, the length of the depth legs 14 is illustrated as H1 and H2 (determined using the surgeon planning of the implant relative to the glenoid). With reference to Fig. 3, it is shown that H1 and H2 may be representative of two distinct dimensions between a glenoid implant 20 and a glenoid cavity C, the glenoid implant 20 shown as having a base plate 21 and a peg 22. The base plate 21 is optional in the implant 20, and supports a tapered head 23 that will be part of the shoulder joint. The H1 and H2 dimensions are based on a planning indication known as Walch glenoid indication, in which the glenoid cavity is reamed into a plane without sacrificing excessively the glenoid cavity surface. H1 and H2 are representative of the spacing between the base plate 21 and the reamed glenoid cavity C (i.e., the recipient site or location) as shown in Fig. 4, whereby the harvesting of graft should have dimensions H1 and H2 to replicate the assembly shown in Fig. 4. The positioning of the glenoid implant 20 also takes into consideration a depth of insertion of the peg 22 in the shoulder blade S. Accordingly, the humerus grafting patient-specific instrument 10 is devised so as to harvest humerus graft G of Fig. 4.

    [0012] Alternatively, the assessment of H1 and H2 may be based on a Favard glenoid indication as shown in Figs. 5 and 6. Whether the glenoid implanting is based on the Walch glenoid indication, the Favard glenoid indication or other implanting in which the glenoid surface is planar, the instrument 10 will be similar with, however, an adjustment of the length of the depth legs 14 as per dimensions H1 and H2, dependent on which of the indications will be used in the planning stages of surgery.

    [0013] With the instrument 10 being created in pre-operative planning, a method for harvesting the humerus graft G may be performed using the instrument 10, as described hereinafter.

    [0014] In Fig. 7, a guide rod 30 is positioned in the humerus H in preparing for the humerus grafting. Although not shown, the positioning of the guide rod 30 may result from the use of different pins and drills to properly orient the guide rod 30, to a desired depth. Other patient-specific instruments may be used to properly orient the guide rod 30, or other technologies such as inertial sensors.

    [0015] Referring to Fig. 8, the guide rod 30 is used with a flat reamer 40. The flat reamer 40 is of the type having a hollow cylinder 41 at the end of which is a disc 42. Accordingly, by use of the reamer 40, the humerus H may have its head flattened as shown in Fig. 9. The flattened head could form the implant interface surface of the graft G. It is also considered to use the native surface without machining same, for example if it has a desired shape (e.g., substantially planar), or if the implant interface surface of the implant may be patient specifically shaped for complementary "negative" engagement with the native surface.

    [0016] Once the head is flattened as in Fig. 9, the humerus grafting patient-specific instrument 10 may be slid onto the humerus H, using the guide rod 30 to form a joint with the base plate 12 of the instrument 10. The diameter of the guide bore 13 of the base plate 12 of the instrument 10 is sized so as to precisely fit onto the guide rod 30. Once the base plate 12 lays flat against the flattened surface of the humerus H (constituting the abutment), as shown in Fig. 10, the cut slot 15 may be pinned to the humerus H by way of pin(s) 50. It is pointed out that, in the illustrated example, the orientation of the instrument 10 relative to the humerus H is of lesser importance than the requirement for the base plate 12 to be flat and in abutment against the humerus H.

    [0017] Referring to Fig. 11, with the instrument 10 pinned to the humerus H by the pins 50, cut blade 60 may be used in the cut slot 15 to perform a depth cut D, to define the glenoid interface surface of the graft G. It may be required to remove the guide rod 30 prior to performing the depth cut with the cut blade 60 so as not to have the guide rod 30 interfere with the cut blade 60. This is dependent on the depth of the guide rod 30. In such a case, the pins 50 ensure that the instrument 10 remains anchored to the humerus H during the depth cut.

    [0018] As shown in Fig. 12, once the depth cut D is made, the guide rod 30 may be reinserted into the humerus H, for a bell saw 70, also known as a cylindrical reamer, to be used to perform the lateral cut, as shown in Fig. 14. This results in the detachment of the humerus graft G from a remainder of the humerus H. The bell saw 70 may have a depth scale thereon, to provide a visual display of depth.

    [0019] In Fig. 15, there is illustrated a technique for removing the humerus graft G, using the glenoid implant 20. By this method, the glenoid implant 20 is forced into the humerus graft G, requiring for example the machining of a bore of adequate dimension in the humerus graft G, until the base plate 21 of the glenoid implant 20 is flush against the surface of the humerus graft G. The humerus graft G is harvested as shown in Fig. 16 by pulling out the glenoid implant 20. At that point, it is possible to install the assembly of humerus graft G and glenoid implant 20 in the manner shown in Figs. 4 and 6, and this may require some reaming and peg drilling to the glenoid cavity C. Fasteners of any appropriate type, and tools (e.g., impactor) may be used to properly implant the combination of the humerus graft G and glenoid implant 20. Also, cement or like adhesive can be used to fasten the graft to the implant.

    [0020] The example described above for the instrument 10 is commonly used when glenoid deformities are generally planar, or machined to be planar as planned. This is a common occurrence and is advantageous as flat reaming minimizes subchondral bone sacrifice. The geometry of the graft G may be defined as having a cylindrical body. A peg bore may be defined along the central axis of the cylindrical body, for the implant peg to pass through the cylindrical body. The central axis of the cylindrical body may be normal to the first end surface of the cylindrical body, whereas the second end surface of the cylindrical body is oblique. In other words, a plane in which lies the second end surface is not parallel to a plane in which lies the first end surface. The angle between the planes is less than 90 degrees, and is commonly between 5 and 45 degrees, although it could be out of that range. Therefore, all three surfaces of the graft G may be machined, in three different steps, while being on the native bone. The machining of the peg bore may be in a fourth separate step, or may consist in the removal of the guide pin 30, the guide pin 30 being selected to have a diameter matching that of the peg 22. Although described as being donated by the humerus, the graft G may be harvested from other sites, such as the iliac crest.

    [0021] Now that the humerus grafting patient specific instrument 10 has been described as used for a flat glenoid surface, another example of a humerus grafting patient specific instrument is set forth, for a frusto-spherical glenoid cavity, i.e., the glenoid cavity is a sphere segment surface. Indeed, in some instances, the erosion is spherical with a glenoid surface medialization due to wear. This is for instance shown in Fig. 18.

    [0022] Therefore, referring to Fig. 17, there is illustrated a humerus grafting patient specific instrument 100 to be used for hemispherical or frusto-spherical glenoid cavities. In similar fashion to the instrument 10, the instrument 100 is patient specific and has a model file 101 featuring modelisation of the patient's anatomy obtained pre-operatively. The instrument 100 has a first guide 102 and a second guide 103, both generally elongated cylindrical portions with channels of circular section that would be mounted onto pins and thus form sliding joints. A depth leg 104 projects from the first guide 102 and has a cut slot 105 (with pin guides 105A) at an end thereof.

    [0023] Referring to Fig. 18, a schematic planning view is provided showing the desired positioning of the glenoid implant 20 relative to the glenoid cavity C. As observed, the glenoid cavity C has a circular outline (circle O shown in Fig. 18), indicative of a frusto-spherical cavity, with a distance D between an underface of the baseplate 21 of the glenoid implant 20 and a bottom of the glenoid cavity C. The depth D is representative of the height of the humerus graft G to be harvested from the humerus H. Moreover, angle α is also to be taken into consideration, as the angle between the axis of the peg 22 of baseplate 21 and line L. Line L passes through point P at the intersection of the axis of the peg 22 with the circle O, and through the center of the circle. All these parameters are obtained preoperatively from the surgeon planning of the implanting procedure relative to the glenoid surface and are part of the model file 101. These parameters are descriptive of the spatial geometry of the graft G to interface the implant 20 to the reamed glenoid cavity C.

    [0024] Referring to Fig. 19, in order to start the grafting procedure, a hemispherical reamer 110 is used to surface the humerus head H into a frusto-spherical shape. Hemispherical reamer 110 has a hollow cylinder 111 that is cannulated to be mounted on the guide rod 30. A saw edge 112 is sized as a function of the dimension of the diameter of the circle O of Fig. 18. Accordingly, various sizes of the hemispherical reamer 110 may be provided, with the operator selecting the appropriate size based on the pre-operative planning and on the model file 101. Hence, the reamed humerus head H has the glenoid interface surface machined onto it.

    [0025] Once the humerus head has been shaped, the instrument 100 may be positioned thereon using the guide rod 30. The guide rod 30 serves as a shaft for the second guide 103, with the angle between the first guide 102 and the second guide 103 being angle α.

    [0026] Referring to Fig. 21, once the instrument 100 abuts against the humerus H, it may be pinned using pin(s) 50. The guide rod 30 may be removed for the cut blade 60 to perform a depth cut of depth D, to form the implant interface surface of the graft G. Once the depth cut has been made, the guide 130 may be repositioned onto the humerus H, but this time using the first guide 102, as shown in Fig. 22.

    [0027] Referring to Fig. 23, a drill tool 120 may then be used to machine a bore in the humerus H, which bore is sized based on the diameter of the peg 22 of the implant 20, as it will receive the peg 22 therein.

    [0028] Referring to Fig. 24, the saw bell 70 may then be used in order to define the size of the graft G to be harvested. Accordingly, based on the preceding steps, humerus graft G is shaped for use in the configuration of Fig.18, and may be harvested.

    [0029] In order to implant it properly (or implant the graft G harvested using the instrument 10) and replicate the planning by setting the graft axial rotation appropriately, different tools may be devised, such as barrel 130 of Fig. 25. The barrel 130 has a cavity 131 that is shaped in patient specific manner, in similar fashion to the instruments 10 and 100. As such, barrel 130 may have a model file. A peg bore 132 is a bottom of the cavity 131, and sized and positioned specifically based on the planned interrelation between the peg 22 and the graft G. Accordingly, the alignments of the peg bore 132, the barrel 130 and the peg bore in the humerus graft G ensure that a single orientation of the humerus graft G in the barrel 130 is achieved, for insertion of the peg 22 in the manner shown in Fig. 26. The barrel 130 further comprises a guide 133 that cooperates with a pin 134 to form a sliding joint.

    [0030] As shown in Fig. 26, an impactor 140 has an implant end 141 devised to support the tapered head 23 of the implant 20. The impactor 140 also has at an opposite end an impact end 142 adapted to be impacted for implanting the implant 20. The impactor 140 also has a guide 143 that will collaborate with the pin 134. This is shown particularly in Fig. 27 in which it is observed that the impactor 140 is guided by the implanted pin 134 to perform the impacting action. The graft could be cemented to the baseplate and not impacted.

    [0031] Referring to Fig. 28, it may however be necessary to machine the glenoid cavities C using a reamer 150 having an arcuate cutting tool 151. It is pointed out that the barrel 130 may be used to machine the glenoid cavities so as to define the peg bore into the glenoid. Accordingly, the implant 20 and the harvested graft G may be implanted in the reamed glenoid cavity C in the manner shown in Fig. 29.

    [0032] The geometry of the graft G may be defined as having a cylindrical body, although an axial length of the cylindrical body may be close to zero at a location. A peg bore may be defined along the central axis of the cylindrical body, for the implant peg to pass through the cylindrical body. The central axis of the cylindrical body may be normal to the first end surface of the cylindrical body, whereas the second end surface of the cylindrical body is spherical. The center of the spherical surface is not aligned with the central axis of the cylindrical body, i.e., it is not coincident with the central axis. Therefore, all three surfaces of the graft G may be machined, in three different steps, while being on the native bone. The machining of the peg bore may be in a fourth separate step. The machining of the peg bore may be in a fourth separate step, or may consist in the removal of the guide pin 134, the guide pin 134 being selected to have a diameter matching that of the peg 22. Although described as being donated by the humerus, the graft G may be harvested from other sites, such as the iliac crest.

    [0033] Therefore, the method can generally be described as a method for creating a graft. According to the method, a cut guide instrument 10 or 100 is obtained, and is specific to a patient's anatomy. The instrument 10 or 100 is the result of pre-operative planning in which the patient's anatomy is modeled, and the spatial geometry of a graft is defined from the surgeon planning by the planning software. Intraoperatively, an exposed surface of a donor bone is resurfaced, to form an implant interface surface (in the case of instrument 10) or a bone interface surface (in the case of instrument 100) of the graft G. The cut guide instrument 10 or 100 is then secured to the donor bone. Using the cut guide instrument 10 or 100, a depth cut in performed the donor bone to form the other of the implant interface surface or the bone interface surface of the graft G. It may be required to further machine the graft G, or the graft G may be harvested right away, for example if the resurfacing has also been used to define the lateral surfaces of the graft G.

    [0034] While the method described above provides an example of shoulder surface, the method could also be used with other joints, or for a non-reverse shoulder surgery.

    [0035] Referring to Fig. 30, there is illustrated a system 200 for generating a model of a patient specific cut guide instrument, such as 10, 100, for harvesting a graft, such as G, for subsequent fabrication and used based on the methods illustrated in Figs. 1-29. In order to generate the model of the patient specific cut guide instrument, such for example at 11, 101 in Figs. 1, 17 and 30, the system 200 must have a model 201 of the graft G. The model 201 is for example the result of pre-operative planning, in which a virtual positioning and orienting of an implant is done on images of a bone. This may be illustrated for example by Figs. 3, 4 and 18, with the graft G being defined by an implant interface surface, a bone interface surface, and a spatial geometry therebetween. The model is specific to a patient, in that it results from an analysis of the patient's data (imagery of bone, for example in 3D, patient condition, etc). The system 200 may also have a model 202 of the donor bone, such as the humerus H. The graft G will be harvested in the donor bone, and therefore the system 200 determines how to alter the donor bone to harvest the graft G, using the model 202. As described previously, the patient specific cut guide instrument 10 is used for harvesting the graft for subsequent implanting without alterations to the outer surface of the graft G, i.e., after harvesting, the graft G already has a geometry corresponding to the model of the graft 201. Some trivial machining may occur after harvesting, such as machining a peg hole of appropriate dimension in the hole remaining from the pin guide 30. However, such machining is not to alter the outer surface of the graft B, i.e., the cylindrical body and its ends.

    [0036] A patient-specific instrument generator 203 outputs the model 11, 101 of the patient specific cut guide instrument 10, 100. The patient-specific instrument generator 203 has a processor unit for operating modules that generate data resulting in the model 11, 101, using models 201 and 202. The patient-specific instrument generator 203 may have a position determination module 204 for orienting and positioning a guide axis or axes, taking into consideration the spatial geometry of the graft G, via the model 201, to make sure there is sufficient bone available for the graft G, without damaging what must remain of the donor bone, as per model 202. As observed in Figs. 1-29, the axes are used to correctly position and orient the instrument 10, 100 on the donor bone, and to guide the tools altering the bone. The position determination module 204 may also position an abutment on the model 202 of a donor bone as a function of the spatial geometry. This may include identifying that the donor bone must be resurfaced to define the abutment, as in Figs. 8 and 19.

    [0037] Once the position determination module 204 has produced the orientation and position of the axis, and determined the abutment (including resurfacing), an instrument body generator module 205 generates the model 11, 101 of the patient specific cut guide instrument 10, 100. As observed in Figs. 1-29, the instrument 10,100 has a body supporting a cut guide with the cut slot 15. The cut guide is used with a cutting tool, such as a saw, to perform a depth cut in the donor bone, the depth cut being positioned and oriented as a function of the contact of the body with the abutment on the donor bone, of the model 201 of the graft, and of the guide axis (axes). One or more guide channels are part of the body for alignment with the guide axis (axes). One or more anchor guides, such as the pin guides 15A, are located in the body of the instrument 10, 100 for securing the patient specific instrument cut guide 10, 100 on the donor bone as abutted with the abutment and aligned with the guide axis. The instrument body generator module 205 may also create other patient specific instruments, such as the barrel 130. The generator 205 outputs a model(s) 11, 101, in any appropriate format, such as non-transient instructions to machine the instrument 10, 100, a 3D printing file, etc.

    [0038] In the system 200, the patient-specific instrument generator 203 may also have a tool selector module 206. The module 206 may identify the various bone-altering tools, such as 30, 40, 70, 120, etc (concurrently as 210) to be used for resurfacing the donor bone, harvesting the graft, etc. The module 206 may also provide data such as depth of penetration in the case of the bell saw 70.


    Claims

    1. A system for generating a model of a patient specific cut guide instrument for harvesting a graft, comprising:

    a model of a graft defined by an implant interface surface, a bone interface surface, and a spatial geometry therebetween, the model being specific to a patient;

    a patient-specific instrument generator for outputting the model of the patient specific cut guide instrument, the patient-specific instrument generator including

    a position determination module for orienting and positioning at least a first guide axis, and for positioning an abutment on a model of a donor bone as a function of the spatial geometry, and

    an instrument body generator module for generating a model of the patient specific cut guide instrument comprising a body supporting a cut guide to perform a depth cut in the donor bone positioned and oriented as a function of a contact of the body with the abutment on the donor bone, and of the model of the graft, a first guide portion for alignment with the first guide axis, and at least one anchor guide for securing the patient specific instrument cut guide on the donor bone as abutted with the abutment and aligned with the first guide axis,

    whereby the patient specific cut guide instrument is used for harvesting the graft for subsequent implanting without alterations to the spatial geometry of the graft.


     
    2. The system according to claim 1, wherein the patient-specific instrument generator further comprises a tool selector module for identifying at least one bone-altering tool to be used for at least one of resurfacing the donor bone and harvesting the graft.
     
    3. The system according to claim 2, wherein the position determination module determines a resurfacing of the donor bone to define the abutment, the resurfacing being to form a planar surface used as the implant interface surface.
     
    4. The system according to claim 3, wherein the instrument body generator module orients the cut guide in the body to form the bone interface surface into another planar surface, the exposed surface being non parallel to the bone interface surface;
    optionally wherein the tool selector module identifies a bell saw to harvest the graft by forming a cylindrical body between the implant interface surface and the bone interface surface, an axis of the cylindrical body being normal to the implant interface surface.
     
    5. The system according to any one of claims 1 to 4, wherein the instrument body generator module generates the model of the patient specific cut guide instrument based on one of the Walch glenoid indication and Favard glenoid indication in a reverse shoulder arthroplasty.
     
    6. The system according to any one of claims 1 to 4, wherein a humerus is the donor bone, and the graft is used to support an implant onto the glenoid in reverse shoulder arthroplasty.
     
    7. The system according to claim 2, wherein the guide portion is a guide channel sized to be used with a guide rod at the first guide axis.
     
    8. The system according to claim 7, wherein the tool selector module selects tools to sliding along the guide rod and into contact with the abutment.
     
    9. The system according to claim 7, wherein the instrument body generator module defines a hole in the body, the hole being sized as a function of a peg bore to be formed in the graft, the peg bore being coaxial with a hole in the donor bone made by insertion of the guide rod.
     
    10. The system according to claim 2, wherein the position determination module determines a resurfacing of the donor bone to define the abutment, the resurfacing being to form a spherical surface portion used as the bone interface surface.
     
    11. The system according to claim 10, wherein the instrument body generator module orients the cut guide in the body to form the implant interface surface into a planar surface.
     
    12. The system according to claim 11, wherein the position determination orients and positions a second guide axis on the donor bone, the tool selector module identifies a bell saw to move along the second guide axis to harvest the graft by forming a cylindrical body between the implant interface surface and the bone interface surface, an axis of the cylindrical body being normal to the implant interface surface.
     
    13. The system according to claim 12, wherein the instrument body generator module generates a model of a patient specific alignment instrument having a receptacle receiving and conforming to the bone interface surface and a hole in the receptacle receiving and aligned with a peg bore coincident with a hole along the second guide axis, to install the implant onto the graft;
    optionally wherein the patient specific alignment instrument further comprises a guide pin and channel assembly to position and impact the implant and graft on the recipient bone.
     
    14. The system according to any one of claims 10 to 13, wherein the tool selector module selects a resurfacing tool to move along a first guide rod coincident with the first guide axis on the donor bone for resurfacing the exposed surface into said spherical surface portion.
     
    15. The system according to any one of claims 1 to 14, wherein the patient specific cut guide instrument for creating the graft comprises
    a model file including a spatial model of a graft defined by an implant interface surface and a bone interface surface of the graft and a spacing therebetween;
    the body including a baseplate adapted to be abutted against the abutment, the cut guide adapted to receive therein a cut blade, and
    at least one depth leg spacing the base plate away from the cut guide;
    wherein the base plate, the cut guide slot and the at least one depth leg replicate parameters of the spatial model of the graft.
     


    Ansprüche

    1. System zur Erzeugung eines Modells eines patientenspezifischen Schnittführungsinstruments zur Entnahme eines Transplantats, umfassend:

    ein Modell eines Transplantats, das durch eine Implantatgrenzoberfläche, eine Knochengrenzoberfläche und eine Raumgeometriet dazwischen definiert ist, wobei das Modell für einen Patienten spezifisch ist;

    eine Erzeugungseinrichtung für ein patientenspezifisches Instrument zur Ausgabe des Modells des patientenspezifischen Schnittführungsinstruments, wobei die Erzeugungseinrichtung für ein patientenspezifisches Instrument folgendes aufweist:

    ein Positionsbestimmungsmodul zur Ausrichtung und Positionierung mindestens einer ersten Führungsachse sowie zur Positionierung eines Abutments an einem Modell eines Spenderknochens als eine Funktion der Raumgeometrie; und

    ein Erzeugungsmodul für einen Instrumentenkörper zur Erzeugung eines Modells des patientenspezifischen Schnittführungsinstruments, das einen Körper umfasst, der eine Schnittführung stützt, um einen tiefen Schnitt in dem Spenderknochen auszuführen, positioniert und ausgerichtet als eine Funktion eines Kontakts des Körpers mit dem Abutment an dem Spenderknochen, und des Modells des Transplantats, eines ersten Führungsteils zur Ausrichtung mit der ersten Führungsachse und mindestens einer Ankerführung zur Sicherung der Schnittführung des patientenspezifischen Instruments an dem Spenderknochen anstoßend an das Abutment und in Ausrichtung mit der ersten Führungsachse;

    wobei das patientenspezifische Schnittführungsinstrument zur Entnahme des Transplantats zur späteren Implantation ohne Änderungen an der Raumgeometrie des Transplantats verwendet wird.


     
    2. System nach Anspruch 1, wobei die Erzeugungseinrichtung für ein patientenspezifisches Instrument ferner ein Werkzeugauswahlmodul zur Bestimmung mindestens eines Knochenbearbeitungswerkzeugs umfasst, das für mindestens einen der folgenden Zwecke verwendet werden soll: Resurfacing des Spenderknochens und/oder Entnahme des Transplantats.
     
    3. System nach Anspruch 2, wobei das Positionsbestimmungsmodul ein Resurfacing des Spenderknochens bestimmt, um das Abutment zu definieren, wobei es sich bei dem Resurfacing um das Ausbilden einer planaren Oberfläche zur Verwendung als Implantatgrenzoberfläche handelt.
     
    4. System nach Anspruch 3, wobei das Erzeugungsmodul für einen Instrumentenkörper die Schnittführung in dem Körper so ausrichtet, dass die Knochengrenzoberfläche in eine andere planare Oberfläche geformt wird, wobei die exponierte Oberfläche nicht parallel zu der Knochengrenzoberfläche ist;
    wobei das Werkzeugauswahlmodul optional eine Glockensäge zur Entnahme des Transplantats bestimmt, durch Ausbilden eines zylindrischen Körpers zwischen der Implantatgrenzoberfläche und der Knochengrenzoberfläche, wobei eine Achse des zylindrischen Körpers senkrecht zu der Implantatgrenzoberfläche ist.
     
    5. System nach einem der Ansprüche 1 bis 4, wobei das Erzeugungsmodul für einen Instrumentenkörper das Modell des patientenspezifischen Schnittführungsinstruments auf der Basis eines der folgenden erzeugt: der Glenoid-Indikation nach Walch oder der Glenoid-Indikation nach Favard in einer inversen Schulterarthroplastik.
     
    6. System nach einem der Ansprüche 1 bis 4, wobei der Spenderknochen ein Humerus ist, und wobei das Transplantat eingesetzt wird, um ein Implantat in einer inversen Schulterarthroplastik auf dem Glenoid zu stützen.
     
    7. System nach Anspruch 2, wobei der Führungsteil ein Führungskanal ist, der für einen Einsatz mit einem Führungsstab auf der ersten Führungsachse bemessen ist.
     
    8. System nach Anspruch 7, wobei das Werkzeugauswahlmodul Werkzeuge für eine Verschiebung entlang des Führungsstabs und in Kontakt mit dem Abutment auswählt.
     
    9. System nach Anspruch 7, wobei das Erzeugungsmodul für einen Instrumentenkörper in dem Körper ein Loch definiert, wobei die Größe des Lochs bemessen ist als eine Funktion einer in dem Transplantat auszubildenden Stiftbohrung, wobei die Stiftbohrung koaxial mit einem durch Einführen des Führungsstabs erzeugten Loch in dem Spenderknochen ist.
     
    10. System nach Anspruch 2, wobei das Positionsbestimmungsmodul ein Resurfacing des Spenderknochens bestimmt, um das Abutment zu definieren, wobei durch das Resurfacing ein sphärischer Oberflächenteil zur Verwendung als die Knochengrenzoberfläche gebildet wird.
     
    11. System nach Anspruch 10, wobei das Erzeugungsmodul für einen Instrumentenkörper die Schnittführung in dem Körper ausrichtet, um aus der Implantatgrenzoberfläche eine planare Oberfläche zu bilden.
     
    12. System nach Anspruch 11, wobei die Positionsbestimmung eine zweite Führungsachse an dem Spenderknochen ausrichtet und positioniert, wobei das Werkzeugauswahlmodul eine Glockensäge bestimmt, für eine Bewegung entlang der zweiten Führungsachse zur Entnahme des Transplantats durch Ausbilden eines zylindrischen Körpers zwischen der Implantatgrenzoberfläche und der Knochengrenzoberfläche, wobei eine Achse des zylindrischen Körpers senkrecht zu der Implantatgrenzoberfläche ist.
     
    13. System nach Anspruch 12, wobei Erzeugungsmodul für einen Instrumentenkörper ein Modell eines patientenspezifischen Ausrichtungsinstruments erzeugt, mit einer Aufnahme, welche die Knochengrenzoberfläche aufnimmt und mit dieser zusammenpasst, und mit einem Loch in der Aufnahme, das eine Stiftbohrung aufnimmt und mit dieser ausgerichtet ist, die mit einem Loch entlang der zweiten Führungsachse zusammenfällt, um das Implantat auf dem Transplantat zu installieren;
    wobei das patientenspezifische Ausrichtungsinstrument optional ferner eine Führungsstift- und Kanaleinheit umfasst, um das Implantat und das Transplantat an dem empfangenden Knochen zu positionieren und zu pressen.
     
    14. System nach einem der Ansprüche 10 bis 13, wobei das Werkzeugauswahlmodul ein Resurfacing-Werkzeug auswählt, für eine Bewegung entlang eines ersten Führungsstabs, der mit der ersten Führungsachse an dem Spenderknochen zusammenfällt, um an der exponierten Oberfläche ein Resurfacing zu einem sphärischen Oberflächenteil vorzunehmen.
     
    15. System nach einem der Ansprüche 1 bis 14, wobei das patientenspezifische Schnittführungsinstrument zur Erzeugung des Transplantats folgendes umfasst:

    eine Modelldatei, die ein räumliches Modell eines Transplantats aufweist, definiert durch eine Implantatgrenzoberfläche und eine Knochengrenzoberfläche des Transplantats und einem Abstand dazwischen;

    wobei der Körper eine Grundplatte aufweist, die an dem Abutment anliegen kann;

    wobei die Schnittführung darin eine Klinge aufnehmen kann; und

    wobei mindestens ein Tiefenfuß einen Abstand von der Grundplatte zu der Schnittführung bereitstellt;

    wobei die Grundplatte, der Schnittführungsschlitz und der mindestens eine Tiefenfuß Parameter des räumlichen Modells des Transplantats nachbilden.


     


    Revendications

    1. Système pour générer un modèle d'un instrument de guidage de coupe spécifique au patient pour le prélèvement d'un greffon, comprenant :

    un modèle d'un greffon défini par une surface d'interface d'implant, une surface d'interface osseuse et une géométrie spatiale entre les deux, le modèle étant spécifique à un patient ;

    un générateur d'instrument spécifique au patient pour produire le modèle de l'instrument de guidage de coupe spécifique au patient, le générateur d'instrument spécifique au patient comprenant

    un module de détermination de position pour orienter et positionner au moins un premier axe de guidage, et pour positionner une butée sur un modèle d'un os donneur en fonction de la géométrie spatiale, et

    un module générateur de corps d'instrument pour générer un modèle de l'instrument de guidage de coupe spécifique au patient comprenant un corps supportant un guide de coupe pour effectuer une coupe en profondeur dans l'os donneur positionné et orienté en fonction d'un contact du corps avec la butée sur l'os donneur, et du modèle du greffon, une première partie de guidage pour l'alignement avec le premier axe de guidage, et au moins un guide d'ancrage pour fixer le guide de coupe d'instrument spécifique au patient sur l'os donneur en butée avec la butée et aligné avec le premier axe de guidage,

    moyennant quoi l'instrument de guidage de coupe spécifique au patient est utilisé pour prélever le greffon en vue d'une implantation ultérieure sans modification de la géométrie spatiale du greffon.


     
    2. Système selon la revendication 1, le générateur d'instrument spécifique au patient comprenant en outre un module de sélection d'outil pour identifier au moins un outil de modification d'os à utiliser pour le resurfaçage de l'os donneur et/ou le prélèvement du greffon.
     
    3. Système selon la revendication 2, le module de détermination de position déterminant un resurfaçage de l'os donneur pour définir la butée, le resurfaçage devant former une surface plane utilisée comme surface d'interface d'implant.
     
    4. Système selon la revendication 3, le module générateur de corps d'instrument orientant le guide de coupe dans le corps pour former la surface d'interface osseuse dans une autre surface plane, la surface exposée n'étant pas parallèle à la surface d'interface osseuse ;
    éventuellement, le module de sélection d'outil identifiant une scie cloche pour prélever le greffon en formant un corps cylindrique entre la surface d'interface d'implant et la surface d'interface osseuse, un axe du corps cylindrique étant perpendiculaire à la surface d'interface d'implant.
     
    5. Système selon l'une quelconque des revendications 1 à 4, le module de génération de corps d'instrument générant le modèle de l'instrument de guidage de coupe spécifique au patient en se basant sur l'indication de glène de Walch ou sur l'indication de glène de Favard dans une arthroplastie inverse de l'épaule.
     
    6. Système selon l'une quelconque des revendications 1 à 4, un humérus étant l'os donneur et le greffon étant utilisé pour soutenir un implant sur la glène lors d'une arthroplastie inverse de l'épaule.
     
    7. Système selon la revendication 2, la partie de guidage étant un canal de guidage dimensionné pour être utilisé avec une tige de guidage au niveau du premier axe de guidage.
     
    8. Système selon la revendication 7, le module de sélection d'outil sélectionnant les outils à glisser le long de la tige de guidage et en contact avec la butée.
     
    9. Système selon la revendication 7, le module générateur de corps d'instrument définissant un trou dans le corps, le trou étant dimensionné en fonction d'un alésage de cheville à former dans le greffon, l'alésage de cheville étant coaxial avec un trou dans l'os donneur fait par l'insertion de la tige de guidage.
     
    10. Système selon la revendication 2, le module de détermination de position déterminant un resurfaçage de l'os donneur pour définir la butée, le resurfaçage devant former une partie de surface sphérique utilisée comme surface d'interface osseuse.
     
    11. Système selon la revendication 10, le module générateur de corps d'instrument orientant le guide de coupe dans le corps pour former la surface d'interface d'implant en une surface plane.
     
    12. Système selon la revendication 11, la détermination de la position orientant et positionnant un second axe de guidage sur l'os donneur, le module de sélection d'outil identifiant une scie à cloche pour se déplacer le long du second axe de guidage afin de prélever le greffon en formant un corps cylindrique entre la surface d'interface d'implant et la surface d'interface osseuse, un axe du corps cylindrique étant perpendiculaire à la surface d'interface d'implant.
     
    13. Système selon la revendication 12, le module générateur de corps d'instrument générant un modèle d'un instrument d'alignement spécifique au patient ayant un réceptacle recevant et se conformant à la surface d'interface osseuse et un trou dans le réceptacle recevant et aligné avec un alésage de cheville coïncidant avec un trou le long du second axe de guidage, pour installer l'implant sur le greffon ;
    éventuellement, l'instrument d'alignement spécifique au patient comprenant en outre un ensemble canal et goupille de guidage pour positionner l'implant et le greffon sur l'os receveur et les frapper.
     
    14. Système selon l'une quelconque des revendications 10 à 13, le module de sélection d'outil sélectionnant un outil de resurfaçage pour se déplacer le long d'une première tige de guidage coïncidant avec le premier axe de guidage sur l'os donneur pour resurfacer la surface exposée dans ladite partie de surface sphérique.
     
    15. Système selon l'une quelconque des revendications 1 à 14, l'instrument de guidage de coupe spécifique au patient pour la création du greffon comprenant
    un fichier modèle comprenant un modèle spatial d'un greffon défini par une surface d'interface d'implant et une surface d'interface osseuse du greffon et un espacement entre elles ;
    le corps comprenant une plaque de base conçue pour venir en butée contre la butée,
    le guide de coupe conçu pour recevoir en son sein une lame de coupe, et
    au moins une patte de profondeur espaçant la plaque de base du guide de coupe ;
    la plaque de base, la fente de guidage de coupe et l'au moins une patte de profondeur reproduisant les paramètres du modèle spatial du greffon.
     




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    Cited references

    REFERENCES CITED IN THE DESCRIPTION



    This list of references cited by the applicant is for the reader's convenience only. It does not form part of the European patent document. Even though great care has been taken in compiling the references, errors or omissions cannot be excluded and the EPO disclaims all liability in this regard.

    Patent documents cited in the description