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WO2023178420A1 - Guides chirurgicaux pour arthroplastie totale inversée de l'épaule - Google Patents

Guides chirurgicaux pour arthroplastie totale inversée de l'épaule Download PDF

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Publication number
WO2023178420A1
WO2023178420A1 PCT/CA2023/050364 CA2023050364W WO2023178420A1 WO 2023178420 A1 WO2023178420 A1 WO 2023178420A1 CA 2023050364 W CA2023050364 W CA 2023050364W WO 2023178420 A1 WO2023178420 A1 WO 2023178420A1
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WO
WIPO (PCT)
Prior art keywords
guide
graft
bone graft
adjustable
bone
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
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PCT/CA2023/050364
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English (en)
Inventor
Graeme HARDING
Martin Bouliane
Aaron BOIS
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Individual
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Individual
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Publication of WO2023178420A1 publication Critical patent/WO2023178420A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/14—Surgical saws
    • A61B17/15—Guides therefor
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    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A61F2/4603—Special tools for implanting artificial joints for insertion or extraction of endoprosthetic joints or of accessories thereof
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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Definitions

  • the present invention relates to methods and devices for creating a patient-specific (i.e., patient-matched) bone graft that can be used to reconstruct a glenoid deformity surgically, and in particular an in vivo or ex vivo surgical guide for reverse total shoulder arthroplasty.
  • Patient-matched metallic glenoid augments can be created using a preoperative computer tomography (CT) scan, and the glenoid baseplate combined with the custom metal augment is then manufactured for intraoperative use.
  • CT computer tomography
  • This process is costly, time intensive and laborious.
  • this method does not restore glenoid bone stock.
  • the CT scans may be limited or of inadequate quality to allow creation of a custom implant, particularly in the revision setting.
  • BIO-RSATM bony-increased offset - RSA, Tomier/Stryker
  • 3D CT Three- dimensional computer tomography
  • surgeons to recreate the exact dimensions of the graft intraoperatively (i.e., replicate the preoperative 3D plan).
  • the graft is shaped freehand by the surgeon with a bone saw or other hand-held surgical instruments.
  • Freehand bone graft creation is imprecise and is also cumbersome and timeconsuming.
  • the graft is placed over the central post of a glenoid baseplate, which is then implanted into the glenoid. Screws are inserted through the periphery of the baseplate and bone graft to compress and stabilize the combined construct (i.e., baseplate and bone graft) into the native glenoid.
  • the current process does not consistently allow the axis of glenoid preparation to be the same as the axis for implantation.
  • the bone graft does not accurately represent the preoperative 3D plan with respect to its size/shape/orientation, and the axis used for glenoid preparation does not match, the graft does not fit well and is compressed unevenly. This can lead to incomplete implant seating and support as well as graft fracture and/or extrusion. Furthermore, the joint line is often excessively lateralized during this process resulting in excessive soft-tissue tension and difficulty in joint reduction which subsequently increases the risk of intraoperative and/or postoperative fracture. [0007] There is a need in the art for improvements to surgical devices and methods which may mitigate these and other difficulties in the prior art.
  • the invention comprises methods and systems for performing reverse total shoulder arthroplasty.
  • Embodiments of the invention allow a surgeon to create a bone graft to an exact specification, which will match the preoperative plan that has been made.
  • Embodiments of the invention allow the axis of preparation and axis of implantation to be the same, simplifying the process of inserting the graft. After the prepared graft is implanted, it will be loaded evenly under the glenoid baseplate. The surgeon can choose to lateralize the joint line or not, and create the graft (i.e., dimensions/shape) which corresponds to this choice.
  • the invention may comprise a method of creating a patientspecific bone graft using a surgical guide for preparing the bone graft during RS A.
  • the desired bone graft comprises a trapezoidal or wedge shape, and thus has a lower flat surface and a wedge surface.
  • the bone graft comprises a step and wedge shape, which adds a step element to the base of the graft.
  • a bone graft cutting guide for creating a custom bone graft having pre-determined shape and dimensions in reverse shoulder arthroplasty, comprising a:
  • the guide comprises:
  • the guide may either be a non-adjustable or monolithic element which may be formed by an additive manufacturing process, such as 3D printing.
  • the guide may comprise an adjustable mechanical device.
  • the guide may comprise two or more elements configured to be used in vivo by attachment to graft stock.
  • the guide elements may be formed by an additive manufacturing process, such as 3D printing.
  • the invention comprises a method of using an external or internal guide, as described herein, to prepare a bone graft having a pre-determined shape and predetermined dimensions.
  • the method may comprise the steps of:
  • Fig. 1 shows a step and wedge bone graft which may be produced by the devices and methods described herein.
  • Fig. 2A shows a non-adjustable monolithic guide for ex vivo use.
  • Fig. 2B shows schematically the insertion of bone stock and the biplanar and non-parallel cuting planes designed specifically to create a ‘step and wedge’ shaped bone graft.
  • Fig. 2C shows an alternative configuration of the guide designed to create a ‘trapezoidal’ shape bone graft.
  • Fig. 3A shows a non-adjustable monolithic guide for in vivo use, positioned on the humeral head.
  • Fig. 3B shows a second guide for in vivo use, creating a second plane of a biplanar bone graft.
  • Fig. 4 shows a trapezoidal bone graft positioned over the central post of a glenoid base plate, with an insertion tool.
  • Fig. 5 A shows an embodiment of an adjustable guide apparatus.
  • Fig. 5B shows the embodiment of Fig. 5 A and the creation of a second cut plane.
  • Figs. 6A and 6B shows preoperative graft planning images including the graft angle and dimension.
  • Fig. 7 shows a mock-up of a bone graft and glenosphere in position after installation.
  • the reverse shoulder arthroplasty (RSA) procedure and the anatomy of a shoulder joint described herein are well known to an orthopaedic surgeon skilled in the art.
  • the bone graft is used to support and align the glenoid baseplate which thereby aligns the glenosphere.
  • Disclosed herein are physical guides to produce a bone graft having a predetermined shape and pre-determined dimensions.
  • the method of using the guide includes the steps of preoperative graft planning (producing a "virtual graft"), manufacturing a custom cutting guide or determining the settings for an adjustable cutting guide, and cutting the graft to shape.
  • the bone graft 10 comprises a bi-planar step and wedge shape, as illustrated in Fig. 1.
  • the bone graft has a base surface 12, an upper step surface 14 which is parallel to the base surface 12, and a wedge surface 16 which is in a plane non-parallel to the base surface.
  • a transverse cross-section close to the base surface 12 will preferably be substantially cylindrical.
  • This biplanar graft is preferred because it allows a specific amount of lateralization, reconstructs the glenoid bone toss (in any location), and contributes to the stability of the graft prior to final insertion of the baseplate.
  • the bone graft may have a trapezoidal shape, again with a base surface and a wedge surface, but without a step portion.
  • Bone graft may be harvested from either the humeral head (autograft and allograft), the iliac crest (typically autograft), or another location of the surgeon's choosing.
  • the surgical guides provided herein guide a cutting tool to precisely cut the bone graft to pre-determined dimensions and angles, which are specific to a patient's anatomy, as determined by a preoperative planning process.
  • the graft may be prepared with one of the guides described herein.
  • the guide 1 comprises:
  • the guide 1 may be a non- adjustable or monolithic guide which may be formed by an additive manufacturing process, such as 3D printing.
  • the guide may comprise a holder and upper guide surfaces which exactly replicates the shape and dimensions of the graft that was determined during the preoperative planning phase.
  • the virtual graft may be used to design the guide as a 3D model, which can then be used to produce the guide.
  • the cutting guide is then 3D-printed using a biocompatible material that is validated for sterilization and approved for surgical use.
  • a cylinder of bone 2 is harvested from the humeral head or alternate location of surgeon’s choice, which is then recessed and fully seated within the graft holder 12 of cutting guide 1.
  • a first cut with a saw S to remove the excess bone is made along the guide step plane 22 to create the step surface, and then a second cut is made along the guide inclined plane 24 to create the wedge surface.
  • the desired bone graft 10 is that portion remaining within the guide 1.
  • FIG. 2C An alternative embodiment is exemplified in Fig. 2C, which would result in a trapezoidal-shaped bone graft, without a step portion.
  • the resulting bone graft will be shaped and sized as determined in the planning stage.
  • the guide may comprise two or more elements configured to be used in vivo by attachment to graft stock.
  • at least two singleuse patient-specific 3D-printed cutting guide elements are developed to create sequential bone cuts of the proximal humerus. The minimum and maximum heights and angle are used from the preoperative plan to determine the cutting plane(s) to create the desired graft.
  • a first guide element 3 fits exactly on the intended graft source with a guide surface positioned to produce a graft of desired pre-determined dimension.
  • the guide element 3 is held in place, partly because of its exact fit over the surface of the humeral head and surrounding osteophytes, and also as it is temporarily held in place with Kirschner wires 32, which are inserted through guide holes formed in the guide element 3.
  • the guide element 3 comprises a guide surface, such as integrally formed slot 34, to guide a first cut, as shown in Fig. 3 A.
  • the slot 34 guides the saw blade S.
  • the resulting cut produces a planar surface 36 on the humeral head, as may be seen in Fig. 3B, which surface 36 will be either the base surface or the wedge surface of the resulting graft.
  • the first guide element 3 is then removed, and a second guide element 4 is then positioned and affixed in place with Kirschner wires 42.
  • the second guide element 4 also comprises a guide surface, such as an integral slot 44 which guides a saw S along a plane which is not parallel to the plane of the first cut. After the second cut, a trapezoidal bone graft 10 is produced.
  • the guide elements may be formed by an additive manufacturing process, such as 3D printing from a virtual model, to produce guide elements precisely shaped to fit the patient's anatomy and to produce a bone graft of pre-determined shape and pre-determined dimensions.
  • the material must comprise a biocompatible material that is validated for sterilization and approved for surgical use.
  • the slot for guiding a saw blade is preferably lined with an abrasion-resistant material, such as titanium or a carbide, to avoid damage during the sawing portion of the operation.
  • the bone graft 10 may then be positioned over the central post 52 of the glenoid base plate 50, ready to be inserted into the glenoid with an insertion handle 54.
  • successive guide elements may be designed and used to create a bone graft with different planes and surfaces. A minimum of two guide elements are required to create a trapezoidal shape, while three guide elements may be used to create a preferred step and wedge shape. Each guide element will have the guide slot positioned in a desired location and angle to create the necessary cutting plane.
  • the guide may comprise an adjustable external cutting guide 60, comprising:
  • each comer post comprising at least one lock nut 68 which may be moved vertically along the comer post, and
  • an adjustable top plate 70 for guiding a saw having a central opening through which the central housing may pass, and comer openings through which the comer posts may pass.
  • the adjustable top plate 70 rests on and is positioned by the lock nuts 68 to create cutting planes at a desired angle and displacement.
  • Each opening may be elongated to permit the top plate to tilt by pivoting about at least one horizontal axis as may be seen in Figs. 5 A and 5B, where the top plate 70 is inclined from front to back. Side-to-side inclination is also possible to create another cut plane if desired.
  • the graft holding platform within the central housing 64 is vertically moveable to create the desired depth of the bone graft.
  • a cylinder of bone 2 is positioned on the graft holding platform within the central housing 64.
  • the first cutting plane is provided by the upper surface 65 of the central housing, which is positioned to create the cut that will provide the depth position to create the step surface.
  • the second cutting plane is provided by the top plate 70, as may be seen in Fig. 5B.
  • the comer posts 66 may be externally threaded while each lock nut 68 has a complementary internal thread.
  • each lock nut may be positioned vertically by simply rotating the nut.
  • the lock nut may simply slide along the comer post and have a clamping mechanism (such as a cam lock) to releasably clamp against the comer post in a desired position.
  • a clamping mechanism such as a cam lock
  • Alternative mechanisms of adjusting and securing the position of the graft holding platform and top plate/cutting surface 70 may be contemplated.
  • the parts are assembled from the base 62.
  • the center- bore/housing 64 is threaded into the base.
  • the comer posts 66 are also threaded into the base.
  • the parts of the guide can be detached for convenient and effective sterilization.
  • the external adjustable guide provides an adjustable graft holding platform that is threaded into the central housing and permits adjustment to a pre-planned depth.
  • Lower lock nuts are placed onto the comer posts at pre-planned heights, which positions the top plate at a precise angle.
  • the top-plate is laid over/through the posts and rests on these four nuts. At this stage, the top-plate is inclined (and can be inclined in two different planes).
  • Upper lock nuts are then placed on top of the top plate to secure it at the desired height.
  • the preoperative planning step may use commercially available ‘surgeon controlled’ 3D planning software, such as BlueprintTM (Stryker), to plan a patient-specific bone graft.
  • the patient’s CT scan is loaded into BlueprintTM and a desired system for the intended procedure is selected (Fig. 6A).
  • the preparation axis is left at zero degrees of ante/retroversion (Fig. 6A), and superior/inferior inclination (Fig. 6B).
  • the glenoid component is positioned appropriately into the glenoid vault.
  • ‘Patientspecific bone graft’ is selected within the planning software and the graft (i.e., ‘digital graft’ or 'virtual graft') is generated including the exact dimensions of the graft (Figs. 6 A and 6B).
  • the shape and dimensions of the digital graft may then be used to design a custom bone graft guide which may then be manufactured for either ex vivo or in vivo use, as described above.
  • the desired device settings for an adjustable device 60 may be easily determined from the dimensions of the digital graft.
  • the required depth of the graft and desired amount of lateralization is shown on the digital graft from the preoperative plan.
  • the angle of the slope on the graft is also known, as are the dimensions of the device itself. Therefore, the required heights of the four comer lock nuts to produce the desired incline of the top plate can be determined preoperatively.
  • each block in the flowchart or block diagrams may represent a module, segment, or portion of code, which comprises one or more executable instructions for implementing the specified logical function(s).
  • the functions noted in the block may occur out of the order noted in the Figures. For example, two blocks shown in succession may, in fact, be executed substantially concurrently, or the blocks may sometimes be executed in the reverse order, depending upon the functionality involved.
  • references in the specification to "one embodiment”, “an embodiment”, etc., indicate that the embodiment described may include a particular aspect, feature, structure, or characteristic, but not every embodiment necessarily includes that aspect, feature, structure, or characteristic. Moreover, such phrases may, but do not necessarily, refer to the same embodiment referred to in other portions of the specification. Further, when a particular aspect, feature, structure, or characteristic is described in connection with an embodiment, it is within the knowledge of one skilled in the art to affect or connect such module, aspect, feature, structure, or characteristic with other embodiments, whether or not explicitly described. In other words, any module, element or feature may be combined with any other element or feature in different embodiments, unless there is an obvious or inherent incompatibility, or it is specifically excluded.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Animal Behavior & Ethology (AREA)
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Abstract

L'invention concerne un guide de coupe de greffon osseux pour créer un greffon osseux adapté à un patient. Le guide est utilisé pour produire un greffon osseux dont la forme et les dimensions sont déterminées en évaluation préopératoire en fonction de l'anatomie du patient, pour une utilisation dans l'arthroplastie inverse de l'épaule, et comprend (a) une première surface de guidage de coupe pour créer une première surface plane de greffon osseux ; (b) une seconde surface de guidage de coupe pour créer une seconde surface plane de greffon osseux, qui n'est pas parallèle à la première surface plane de greffon osseux. Les surfaces de guidage de coupe sont intégrées dans un dispositif de guidage externe réglable, un élément ex vivo non réglable ou au moins deux éléments de guidage in vivo non réglables.
PCT/CA2023/050364 2022-03-23 2023-03-21 Guides chirurgicaux pour arthroplastie totale inversée de l'épaule Ceased WO2023178420A1 (fr)

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US202263322757P 2022-03-23 2022-03-23
US63/322,757 2022-03-23

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Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20160345987A1 (en) * 2015-05-28 2016-12-01 Zimmer, Inc. Patient-specific bone grafting system and method

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20160345987A1 (en) * 2015-05-28 2016-12-01 Zimmer, Inc. Patient-specific bone grafting system and method

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