TAILOR-MADE SURGERY GUIDES, METHODS FOR MANUFACTURING THEM AND USE THEM.

专利摘要:
The invention relates to surgical guides that are used during reconstructive bone surgery to guide a surgical instrument or device. More specifically, the conductors are characterized by the fact that they are adapted to the implant rather than to the bone.
公开号:BE1019821A3
申请号:E2010/0766
申请日:2010-12-28
公开日:2013-01-08
发明作者:Frederik Gelaude；Tim Clijmans
申请人:Mobelife N V；
IPC主号:

专利说明:

TAILOR-MADE SURGICAL GUIDES, METHODS FOR MANUFACTURING THEM AND USE THEM
FIELD OF THE INVENTION
The present invention relates to surgical guides used during reconstructive bone surgery, more particularly during reconstructive joint surgery, for guiding a surgical instrument or device. The present invention further relates to methods of manufacturing these surgical guides and to specific methods of using the surgical guides of the invention in reconstructive bone and joint surgery.
BACKGROUND
In most bone or joint arthroplasty, and / or reconstruction surgery procedures, a bone or joint is replaced with a prosthetic implant. The main purpose of an arthroplasty intervention is to relieve (arthritis) pain or to repair serious physical joint damage that results, for example, from trauma. When a prosthesis fails, an arthroplasty revision is performed. This procedure is technically more difficult and time-consuming than the primary intervention and the result is often less satisfactory, both because there is less bone stock to work with and because the removal of suture cement or prosthetic components can result in fracture or perforation of the bone. With each successive joint overhaul, the risk of infection and the symptomatic loosening of the prosthesis can increase significantly. Revision surgery becomes more frequent as the population ages and patients receive prostheses at an increasingly young age.
The treatment of bone and joint defects is gradually becoming more complex. While it started with standard interventions using out-of-stock prosthetic components, it has evolved into patient-specific surgery plans and patient-specific implant designs. The accurate and stable attachment of implants to the bone or joint remains one of the most important steps in arthroplasty interventions, while it becomes increasingly difficult.
The standard process for attaching or anchoring an implant to the bone with screws is usually a two-step procedure. First the screw conveyor is pre-drilled with a specific instrument. This is followed by inserting the screw along the predrilled screw path. Some self-tapping screw types do not require pre-drilling; the direct feed of the screw directly establishes the screw path.
Unfortunately, this anchoring process has a number of important disadvantages.
Deviations in the direction and / or location of the screw path often lead to a suboptimal screw fraction that can cause damage to soft tissue. The pre-drilling and / or placement of the screws is often done by the surgeon with the loose hand, with only a limited view of the bone due to the available surgical incision. In addition, where the surgeon has a sufficient view of the patient and a broad view of the implant and the screw hole and is able to orient the pre-drilling instrument in any direction (which is not often the case), the surface curvature of use the implant around the screw hole as a visual reference and he will aim to orthogonally position the instrument with respect to the local implant surface. As a result, the screw directions obtained are often suboptimal and / or deviate from a preoperative plan. For example, screws can be guided into poor-quality bone, or have only a limited traction length. In addition, a shift of the implant away from the optimum location before the pre-drilling has commenced can lead to screw locations, i.e., insertion points of the screw paths into the bone, from a predetermined location.
Deviations in the direction and / or location of a screw path can also cause the screws to mutually intersect, whereby, for example, the input of a first screw (either with or without a planned direction) blocks the input of the next. Unused screw holes have a bad influence on the long-term integrity of the implant, unless another part of the implant compensates for the local reduction in material volume. However, this implies the use of more implant material, for example, thickening of the implant, making it wider, and / or requires larger areas of contact with the bone. The latter is also harmful to the maintenance of soft tissue.
Specific tools and technologies have been developed in the past to solve the aforementioned problems associated with the implantation or anchoring process.
For example, navigation technology was used as a global location system for the surgeon. For example, infrared sensors placed next to the bone or joint in the operating room function as satellites that constantly monitor the location of markers and instruments placed along the anatomy of a patient. Unfortunately, this technology is expensive and intra-operatively very time-consuming.
A system for attaching an implant to a bone is provided in US 7,153,309 (Huebner et al.), Wherein a conductor device is attached to a bone plate. However, the use of this device is limited in practice to anatomical areas that can be extensively exposed or easily accessed from different directions. For example, the device does not allow a pre-bore from the ipsilateral side of a bone plate, a procedure that is often required, for example, in implant surgery of the hemi-pelvis, scapula, or lower jaw. US2008 / 0183172 discloses a bone plate guide that is more compact but also includes a projection protruding from the guide and designed to be received within an opening in the bone plate for securing the plate guide to the plate. The aperture can be a bone screw-receiving aperture that is inherently present on existing bone plates or an aperture designed to receive a projection that includes a resilient finger. However, these devices can only be used in cases of bone repair (after trauma, with more bone fragments), and not for bone and joint repair such as in arthroplasty. In addition, the plate conductor mounting systems described determine the direction and point of entry of a connection characteristic with respect to the plate, and (only if the plate is patient-specific) also with respect to the bone. Accordingly, no absolute reference is required to transfer a pre-operative surgery plan to the patient's bone geometry and derived from medical images on the patient's bone during surgery. Finally, the conductors are physically attached to the plate, which requires fixing elements on both components and, moreover, requires assembly manipulations.
Drill guide cylinders with standard dimensions have been described which can be screwed into the screw hole of an implant (such as for example for the Compilant Pre-Stress (CPS) device from Biomet Ine .; Warsaw, Indiana). For reasons of manufacturability, time to set up a machine, and cost, this guidance solution is limited to large ranges of implants available from stock for which it is economically advantageous to set up expensive wire drawing machines.
Patient-specific bone guides have a unique (partial) connection to a portion of the surrounding bone, and therefore guide elements, such as bone drilling and / or cutting elements, into an unambiguous and precisely planned trajectory or direction in the bone (Tardieu PB (2007) Int. J. Periodontics Restorative Dent. 27 (2): 141-149; Kunz Μ (2007) Proceedings of the 7th Annual Meeting of CAOS-International: 159-161; Lombardi Jr. AV et al (2008) BFA Orthopedics; 31: 927). However, a customized bone conductor is not always a guarantee for adequate implant attachment, especially in the case of a patient-specific implant. For certain anatomical areas, and especially in complex revision cases, the only bone areas that can be exposed and reached through the surgical window are small in number, small and spread out. One could think of a patient-specific implant that reaches these areas for confirmation. Predrilled screw holes could be made with a plastic implant replica that serves as the basic framework for the bone guides. However, this is impractical and ineffective since the conductor frame structure is taken out and the implant has to be reinserted, while the pre-bore sites must be followed. Furthermore, the use of a Kirchner thread to track the locations of the pre-bore while the guide is being pushed out and the implant is being pushed in is not appropriate and not sufficiently accurate.
Accordingly, there is a need for alternative and improved (custom-made) surgical guides that are stable and that make it possible to accurately insert a surgical instrument into the bone or joint of a patient.
SUMMARY OF THE INVENTION
The present invention relates to tailor-made surgical guides for patient-specific bone implants, which ensure stable guidance of the surgical instrument into the bone, as well as accurate attachment of the bone implant. Instead of being mounted on one or more patient-specific surfaces of the bone, such as with surgical bone guides, the guides of the present invention are placed directly on the final patient-specific bone implant. This is ensured by a specific connection between the customized surgical conductor and one or more surface structures of the patient-specific bone implant and / or by the patient-specific localization and orientation of the conductor elements. After using the custom-made surgical guides according to the invention, the patient-specific implant can be placed directly on its final and correct position on the bone, with the risk of inaccurate reintroduction after pre-drilling or other preparatory operations, which is often a problem when using customized bone guides, is avoided. Accordingly, the custom-made conductors of the present invention allow a more correct and accurate attachment of the implant to the bone compared to the known surgical conductors used in bone and / or (complex) joint arthroplasty.
In a first aspect, the present invention provides tailor-made surgical guides for patient-specific bone implants, more particularly for bone implants with a patient-specific morphology, most particularly bone prostheses. The customized surgical guides for surgical instruments for placement on a patient-specific implant according to the invention comprise (i) one or more customized surface structures that extend over more than at least a portion of the patient-specific morphology of the implant and / or (ii) one or more customized conductor elements and characterized in that the conductor and the bone implant are connected to each other by means of a unique connection, ensured by the complementarity between said patient-specific morphology of said bone implant and at least one of said one or more customized surface structures.
In particular embodiments, the customized surgical guides of the present invention are specifically suited for placement on a bone implant with a patient-specific morphology, ie, a shape specific to each patient and (i) comprising one or more customized surface structures that extend over at least a portion of the patient-specific implant morphology, and [ii) one or more custom-made conductor elements and characterized in that the custom-made surgical conductor and the patient-specific bone implant are connected to each other by means of of a unique connection ensured by the complementarity or congruence between said patient-specific morphology and at least one of said one or more customized surface structures. In the latter embodiments, the unique connection is optionally further ensured by the position and orientation of the customized conductor elements.
In particular embodiments, the one or more customized surface structures of the surgical guides of the invention extend along the patient-specific surface of the implant in at least two, more particularly at least three, different major directions to improve the stability of the to further insure conductors.
In particular embodiments, the tailor-made surgical guides for patient-specific bone implants, and more particularly the tailor-made surface structures thereof, are made via additive manufacturing techniques.
In particular embodiments, the custom-made surgical conductors of the invention may further comprise one or more interconnecting structures interconnecting the one or more surface structures and the one or more conductor elements. In these specific embodiments, the one or more conductor elements may be attached to the one or more connecting structures.
In further particular embodiments, the one or more surface structures and / or the one or more conductor elements and / or the connection structure of the custom-made surgical conductors of the invention may comprise one or more locking elements that can be integrated into the surface structures or the connection structure and / or which may be extensions of the one or more conductor elements. These one or more locking elements serve to secure the surgical guide to the patient-specific implant in a certain fixed position. In special embodiments, the surgical guides according to the invention do not comprise a specific locking element.
In particular embodiments, the one or more conductor elements of the custom-made surgical conductors of the invention are boron conductor elements or cutting conductor elements. In further particular embodiments, the guide elements further comprise a stopper, such as a drill stopper or a cutting stopper.
In particular embodiments, the custom-made surgical guides according to the present invention further comprise an element, such as, for example, a wing element, which serves as a visual reference.
In particular embodiments, the custom-made surgical guides are designed to fit a patient-specific acetabular implant. In a further particular embodiment of such guides for a patient-specific acetabular implant, the connection structure is a ring structure that fits on the acetabular edge of an acetabular implant and at least one or more surface structures are designed to be on one or more surfaces of the patient-specific acetabular implant. More specifically, the tailor-made surgical guide and the acetabular implant are connected in a unique connection, ensured by the congruence, more particularly by the said complementarity between the patient-specific (external) morphology of the acetabular implant and at least at least one of one or more customized surface structures and / or the orientation and position of the conductor elements. In special embodiments, the unique connection is ensured by the congruence or complementarity between the patient-specific (external) morphology of the acetabular implant and at least one of one or more surface structures that fit on the surface of the patient-specific acetabular implant. Such surfaces of the patient-specific acetabular implant optionally include surfaces designed for placement on the ischium, ilium and / or pubis and optionally insure replacement of one or more parts thereof. Namely, in particular embodiments, the implant is designed based on information obtained from patient-specific medical images of the ischium, ilium and / or pubis and uniquely corresponds to the specific bone geometry of the ischium, ilium and / or pubis of the patient in which it is introduced, resulting in a patient-specific morphology of the implant. In a particular embodiment, one surface is provided that is designed for placement on the ilium.
In yet a further aspect, the present invention provides methods for manufacturing customized surgical guides for a patient-specific bone implant according to the invention. In particular embodiments, the methods of the present invention include a manufacturing process that causes the conductor elements to be positioned in accordance with predetermined screw insertions, and one or more surface structures of the conductor specifically fit the patient-specific bone implant.
In particular embodiments, the methods include the steps of: (a) obtaining an image of the bone and design of the patient-specific implant thereon; (b) determining one or more screw paths with the aid of a schedule; (c) designing a customized surgical conductor such that - the conductor elements are positioned in accordance with the predetermined screw paths, and - one or more surface structures provide a support structure that connects the one or more conductor elements and specifically fits the patient- specific bone implant; and (d) manufacturing the customized surgical guide based on the information provided in step (c).
In further particular embodiments, the methods for manufacturing a custom-made surgical guide for surgical instruments for placement on a patient-specific bone implant according to the invention comprise the steps of: (a) designing a custom-made surgical guide comprising one or comprises more customized conductor elements and one or more customized surface structures based on: (i) an image of the bone and the patient-specific bone implant thereon and (ii) one or more screw paths determined by pre-operative planning. The methods further include step (b) of producing, by an additive manufacturing technique, the customized surgical conductor based on the design obtained in step (a), wherein: the one or more conductor elements of said conductor are positioned in accordance with the pre-operatively planned screw paths, and the one or more customized surface structures of the conductor ensure a unique connection between the patient-specific bone implant and the conductor through the congruence, more particularly the complementarity between the customized surface structure and patient-specific morphology of the patient-specific bone implant.
In particular embodiments of the soaking methods of the present invention, it is provided that the one or more conductor elements of the conductors are positioned to correspond to one or more screw paths defined by pre-operative planning. According to a special embodiment, the methods comprise the step of determining one or more screw insertions with the aid of a planning, taking into account one or more of the following criteria: - obtaining an optimum number of non-intersecting drilling directions for screw paths; - ensuring that the screw paths run through bone volume with the optimum available quality; - ensuring the optimum length of the screw path; and - ensuring that the surrounding healthy soft tissue is optimally preserved.
In particular embodiments, the step of ensuring that the screw paths run through bone volume with optimum available quality is determined from gray levels in medical images.
The tailor-made surgical conductors obtainable by the methods of the present invention not only ensure improved accuracy compared to prior art conductors, but also make it possible to provide guidance in complex bone reconstruction. Consequently, surgical conductors obtainable with the methods of the present invention are new and inventive to the standard conductors or even the so-called "tailor-made" conductors disclosed in the prior art.
In a further aspect, the present invention provides combinations of patient-specific bone implants and a tailor-made surgical guide according to the invention. It will be understood that the customized surgical guides of the invention are designed to specifically fit the patient-specific bone implant of the combination.
In a further aspect, the present invention relates to the use of the guides of the invention for attaching a patient-specific bone implant to a bone. More specifically, the invention provides methods for attaching a patient-specific bone implant to a bone, comprising the steps of: (a) placing a custom-made surgical guide according to the invention on a patient-specific bone implant; (b) introducing screw conveyors with the designated surgical tools; (c) removing the customized surgical guide; and (d) attaching the patient-specific bone implant to the bone with screws, wherein step (d) of attaching a patient-specific implant can be done either before or after step (c) or in both cases.
The invention further provides computer programs for performing the methods of the present invention, more particularly computer program products for a computer to be able to fully or partially implement the methods according to the invention described herein. More specifically, computer programs are provided for providing a design of a custom-made surgical guide comprising one or more custom-made guide elements and one or more custom-made surface structures based on (1) one or more images of the bone and the patient-specific bone implant thereon; and (2) one or more screw paths defined by pre-operative planning, the one or more conductor elements of the conductor being positioned in accordance with the pre-operatively planned screw paths, and the one or more customized surface structures of the conductor ensure a unique connection between the patient-specific bone implant and the conductor by means of a congruence or complementarity between the customized surface structure (s) and the patient-specific morphology of a patient-specific bone implant.
BRIEF DESCRIPTION OF THE DRAWINGS
The following description of the figures of specific embodiments of the invention is by way of example only and is not intended to limit the present explanation, its application or use. In the drawings, corresponding reference numbers refer to the same or corresponding parts and features.
Figure 1 Example image of a customized surgical drill guide for a patient-specific acetabular implant according to a particular embodiment of the present invention.
Figure 2A Drawing of a left hemi-pelvis with a large acetabular bone defect. Figure 2B Drawing of a left hemi-pelvis with a large acetabular bone defect reconstructed by a patient-specific acetabular implant.
Figure 2C Complete assembly of a left hemi-pelvis with a large acetabular bone defect with a patient-specific implant and a custom-made surgical guide according to a particular embodiment of the invention.
Figure 2D An enlarged view of the central portion of a custom-made surgical guide according to a particular embodiment of the invention.
2E is an enlarged view of cylindrical drill guide elements of a custom-made surgical guide according to a particular embodiment of the invention, wherein the guide elements are placed on the patient-specific ilium region of the implant.
Figure 3 A bespoke surgical guide according to a particular embodiment of the invention, designed to fit a patient-specific acetabular implant.
Figure 4 A cross-sectional view of a cylindrical drill guide element of a custom-made surgical guide according to a special embodiment of the invention, with (right) and without (left) extension.
Figure 5 A custom-made surgical guide according to a particular embodiment of the invention that includes a wing member that serves as a visual reference for performing a surgical interaction.
Figure 6 A customized surgical guide according to a particular embodiment of the invention comprising a cylindrical drill guide element that is halved in length, allowing, for example, (partial) insertion of a screw directly into the implant, and then the removal of the customized made conductor with the inserted screw remaining in place.
List of reference numbers used in the Figures. Each of these illustrations represents particular embodiments of the features involved and the corresponding features should not be interpreted as being limited to this specific embodiment.
(1) Bone model: left hemi-pelvis (2) Patient-specific acetabular implant (3) Tailor-made surgical guide according to a specific embodiment of the invention (4) Drilling directions or screw paths (5) Central (interconnecting) ring structure, designed to specifically fit on the acetabular edge of a patient-specific implant according to a specific embodiment of the invention (6) Locking elements (an example, e.g. on the central ring structure (5)) (7), (8) and (9) One or more surface structures (10) and (11) One or more conductor elements (12) Implant screw holes (13) Acetabular edge of a patient-specific implant (14) Cavity formed by the acetabular portion of a patient-specific implant (15) Cylindrical ends conductor elements which are cut either straight, obliquely or according to a complex shape.
(16) Extension of cylindrical guide elements (17), (18) and (19) Patient specific areas on an external surface of an acetabular implant (20) Disc-shaped visual reference ring (21) Bridge element (22) Wing element serving as a visual reference for performing a surgical interaction (23) Cylindrical conductor elements that are halved lengthwise
DETAILED DESCRIPTION
The present invention will be described with respect to particular embodiments, but the invention is not limited thereto but only by the claims. No reference sign in the claims will be construed as limiting the scope.
Where the term "comprising" is used in the present description and claims, it does not exclude other elements or steps. Where an indefinite or definite article is used when referring to a singular noun eg "an", "the" or "it", this includes a plural of that noun unless specifically meant otherwise.
Furthermore, the terms first, second, third and the like in the description and in the claims are used to distinguish between similar elements and not necessarily for describing a sequential or chronological order, unless specified. It is to be understood that the terms thus used are interchangeable under appropriate circumstances and that the embodiments of the invention described herein are suitable for operation in sequences other than those described or illustrated herein.
The terms or definitions used herein are provided merely as an aid to understanding the invention.
The present invention provides tailor-made surgical guides for patient-specific bone (or joint) implants, which both ensure stable introduction of a surgical instrument into a bone (or joint) as well as ensuring accurate attachment of the implant to the allow bone (or joint).
The term patient-specific implant as used herein refers to an implant at least a portion of which is formed to fit a patient's specific bone geometry. Thus, a conductor according to the present invention is intended to fit specifically to an implant that is itself specific to a particular patient. In the context of the present invention, and more particularly when referring to the unique connection of the conductor to the patient-specific implant, the terms "congruence" and "complementarity" are used. Two surfaces are considered "congruent" , if the surface features match, which may be the result of a similarity of features (one surface that essentially corresponds to a template taken from the other) and / or may be the result of one or more specific features of one surface is designed to fit on the other surface, the term "complementary" more strongly emphasizes the similarity of features, which in the context of a patient-specific implant typically implies that the one or more contact surfaces of the implant are complementary to the remaining area or areas of the bone or joint, and thereby a (patient) - specific connection is insured specific connection of the implant is ensured during the planning and design of the implant, and may imply that a clearance of 0.1 to 0.5 mm is provided in specific areas between the implant CAD model and the prepared bone CAD model. In the context of the conductors of the present invention, this implies that the one or more contact surfaces and / or the conductor elements of the conductor are complementary to the external surface of the implant, such that they ensure a (patient and implant) specific connection .
In particular embodiments of the present invention, the patient-specific implants are replacement bone prostheses, i.e., they replace at least a portion of a bone or joint that has been lost due to injury (traumatic) or missing from birth (congenital). This type of replacement bone prosthesis is different from medical devices such as screws or plates that only serve to attach existing bone parts to each other. In addition to including a surface complementary to the remaining area or regions of the bone or joint to which the implant is to fit, these patient-specific implants also imitate the surface of the original (ie, non-injured) and absent part of the implant. bone or joint and / or replace it functionally. Preferably, where possible, the surface of these implants seamlessly connects to the remaining surfaces of the bone adjacent to the implant site. Consequently, in particular embodiments, the patient-specific implants of the present invention are characterized by an "external" morphology that is patient-specific. The "external" morphology includes one or more surfaces of the implant that replaces the original surface of the bone or joint. In these embodiments, the implant is not only designed to specifically fit to remaining areas of the bone or joint to ensure seamless restoration of the injured bone or joint, but given that the implant has at least partially one or more anatomical features of the bone or joint, it also imitates the original anatomical characteristics of the bone or joint and / or replaces it functionally.
Patient-specific implants have the advantage that they have a better anatomical connection compared to conventional standard implants. This reduces the operating time and results in a more durable and better functioning implant. Moreover, in specific cases of reconstructive bone and joint surgery, for example cases with large bone defects and / or malformations, patient-specific implants are simply the only alternative since standard implants simply do not provide stable support and confirmation, and no function. Patient-specific implants are typically designed based on medical images (such as a Computer Tomography (CT) dataset) of the bone. A patient-specific implant may include an implant from stock that is adapted (e.g., pre-bent) to the shape of the patient's bone (and / or bone defect) prior to the start of surgery. Patient-specific implants not only preferably have a single connection (i.e., only one position fits), but also a unique connection with the bone structure in which they are introduced (i.e., only suitable for the specific patient). In addition, in optimal conditions, as set forth above, patient-specific implants may have a patient-specific external morphology. This unique connection corresponds to the position of the surgical guide on the implant that is provided in the planning of the surgical intervention.
More particularly, the present invention in specific embodiments provides customized surgical guides for surgical instruments suitable for placement on patient-specific bone implants, which are placed on the patient-specific bone implant (and not or not exclusively on the bone), by specific to fit on one or more surfaces of a patient-specific implant. At the same time, the custom-made surgical guides according to the invention provide absolute directions and / or locations of drilling and / or cutting paths since the patient-specific implant specifically fits on the bone, and the conductor uniquely (ie only in that position) on fits the patient-specific implant.
The customized surgical conductors of the present invention include at least one or more surface structures and one or more conductor elements. In particular embodiments, at least one of the one or more surface structures is designed to specifically fit the external morphology of a patient-specific bone implant. The various components of the surgical guides according to the present invention are described in more detail below.
The bespoke surgical guides of the present invention include one or more surface structures that are structures that extend over at least a portion of the patient-specific surface of the implant. The one or more surface structures may have one or both of the following functions. In particular embodiments, the one or more surface structures ensure the unique connection of the surgical guides to the patient-specific implant. Accordingly, the surface structures comprise one or more areas where the correct placement of the conductor on a patient-specific implant is ensured. In particular embodiments, such surface structures coincide with and follow (i.e. are congruent or complementary to) the outer structure (or external morphology) of the implant.
The one or more surface structures of the customized surgical conductors of the present invention can also serve as a base or support structure for one or more conductor elements of the conductors.
In particular embodiments, the outer structure or external morphology (i.e., the structure on the implant side that is not in contact with the bone in which the implant is placed) of a patient-specific implant are patient-specific. The customized conductor is designed to fit uniquely (i.e., only in one position) to the outer structure of a patient-specific implant.
In particular embodiments, one or more surface structures of the custom-made surgical conductors of the invention, on the side designed to fit on the surface of the implant, comprises at least one region (hereinafter also referred to as "implant-specific region") that is precisely and completely complementary, ie specifically fits on a specific area of a patient-specific bone implant on which the conductor must be placed.
In particular embodiments, congruence or complementarity between the area on the patient-specific implant and the area on at least one of the surface structures of a custom-made conductor according to the invention may imply a play between the conductor surface and bone implant. In particular embodiments, this specific connection implies the planning of a clearance of 0.1-0.5 mm on the implant-specific region or regions between the conductor and the implant.
In these specific embodiments of the invention, (ie where one or more surface structures comprise an implant-specific region) when one or more implant-specific regions of the one or more surface structures are contacted or placed opposite their corresponding complementary surfaces of the patient -specific bone implant, the surfaces fit together, they fit in and / or make contact with each other, whereby the conductor is fixed in a predetermined position. This position is not only the only position in which the surgical guide can be placed on the implant, but is also "unique" for the patient-specific implant (i.e., the guide does not fit on another implant with the same accuracy). Accordingly, in these embodiments, a unique connection between the conductor and the implant is ensured by the one or more surface structures, more particularly by the implant-specific regions thereon.
It is noted that the custom-made conductors according to these embodiments of the invention, while intended to fit uniquely on a patient-specific implant, in addition to the surfaces or parts thereof that provide the unique connection to the patient-specific insuring the implant, may include surfaces or parts thereof which, upon placement, contact the bone and are supported by the bone. Optionally, the one or more surfaces or parts thereof that contact the bone may comprise areas that specifically link with areas of the bone.
In specific embodiments, the three-dimensional connection of the contact area between the one or more surface structures of the customized surgical conductor and the patient-specific implant ensures the stability of the conductor placed on the implant with both translation and rotation (either uni or bi). directional) along and / or around a certain axis.
Alternatively, where the outer surface of a patient-specific bone implant is generic, such an area of a surface structure can be adapted to fit a specific area of this generic outer surface. Furthermore, the outer surface of a patient-specific implant may comprise both patient-specific and more generic parts, such that the one or more surfaces of the custom-made conductors of the invention have one or more regions with a generic connection and one or more regions with may include a patient-specific connection.
The precise size and shape of the one or more surface structures of the conductor are not critical to the invention but will be determined by the shape of the patient-specific implant. In particular embodiments, the patient-specific regions on the one or more surface structures comprise at least 30% of the surface of the conductor contacting the implant. More particularly, this extends to at least 50%, even more particularly to 50 to 90, or even to more than 95% of the surface of the conductor contacting the implant. As explained above, the patient-specific regions may also include sections that contact the bone.
In particular embodiments, the surface structures correspond to flanges, ie longitudinal structures extending in one or more different directions and accurately and stably adjusting the customized conductor on the implant and / or supporting one or more conductor elements to make allow drilling or cutting paths of the implant in one or more underlying bone structures. According to these embodiments, the customized surgical conductors are provided with one or more, two or more, three or more flanges. Such flanges can be connected through one or more connection structures, as explained below. In particular embodiments, the one or more customized surface structures of the surgical guides of the invention extend along the patient-specific surface of the implant in at least two, more particularly at least three, different directions, to improve the stability of the to further insure conductors. In further particular embodiments, the custom-made conductors according to the present invention comprise at least three flanges which, projected on a surface, extend in three directions on the surface (in the surface of the surface) of the implant of which at least two directions are less than 180 ° C.
In particular embodiments, the one or more surface structures of the custom-made surgical guides of the invention may, irrespective of their other characteristics, comprise one or more locking elements, which provides an (additional) coupling of the surgical guide to the patient-specific guide. Such connecting features can be three-dimensional features that are specifically designed on a conductor / implant combination. The unique connection of the conductor to the implant is ensured by the surface structures and / or the conductor elements alone, but the locking elements can further ensure that the conductor is held in the unique suitable position. In particular embodiments, the conductors according to the invention do not comprise a specific locking element. In further particular embodiments, the surgical guides according to the invention do not comprise a locking element on a surface structure.
The customized surgical conductors of the present invention further include one or more conductor elements for guiding a surgical instrument or device into the bone (or joint) of a patient. The one or more guide elements each include at least one means for guiding an instrument such as, but not limited to, a drill, a drill, a saw, a jigsaw, a lateral drill, or another cutting, milling, or drilling tool, or another aid such as a fastener, more particularly a screw, the orientation and position of which correspond to a plan.
Where the device is a screw or the surgical instrument is a drill or a bit, a guide element of the surgical guide according to the invention may comprise at least one cylindrical hole. Where the guide is a drill guide, the diameter of the drill guide element is determined based on the diameter of the pre-drilling tool. In particular embodiments, where the surgical instrument is a saw, a jig saw, a cutter or a lateral drill, a guide member may include at least one (narrow) groove or a flat surface. The height of the one or more conductor elements of the surgical conductor according to the invention is determined to provide sufficient stability and / or guidance to the surgical instrument to be introduced.
The guide element of the surgical guide according to the invention is typically cylindrical, but the ends (15) can be cut straight, obliquely or according to a complex shape (see Figure 2E) to fit into the available workspace and / or surgical window. More specifically, the fully customized surgical guide must fit into the typical V-shaped surgical incision space during application, and should therefore allow (temporary) soft tissue lining when - for example - placed under muscles.
The one or more conductor elements may optionally include a safety stop to prevent a surgical instrument from shooting into the bone beyond a planned depth. For example, in the case where the surgical instrument to be introduced into the bone or joint is a drilling instrument, such as a drill or a boat, drill stoppers can be used to prevent the surgical drill from moving beyond a planned or predetermined depth into the bone shoot. Alternatively, in the case where the surgical instrument to be introduced into the bone or joint is a sharp instrument, such as a saw or a jigsaw, cutting tips can be used to prevent the surgical cutting instrument from moving beyond a planned or predetermined depth into the bot shoots.
The conductor elements can be further adapted to allow the attachment of the implant prior to drilling and / or removal of the conductor. For example, a cylindrical drill guide element can be halved lengthwise (as shown in Figure 6), allowing the direct (partial) insertion of a screw into the implant, and then removal of the customized conductor with the inserted screw remaining in place to sit. Doing this reduces the degree of freedom of a patient-specific implant and the custom-made guide during drilling, and ensures that the correspondence between pre-bores and screw holes is not lost. For example, where the type of screw is a self-tapping type of screw, pre-drilling is not required, which allows the direct introduction of the screw and the immediate establishment of the screw path along the predetermined path.
The position of a conductor element included in the surgical guides of the present invention is typically determined by the planned direction of a surgical instrument in the bone or joint. As such, the conductor elements are "tailor-made" to the specific requirements as determined by the schedule. The patient-specific implant will typically be provided with holes corresponding to the predetermined screw inserts and the position of the conductor elements in the corresponding op bespoke surgical conductor is insured to allow guiding a surgical instrument through these holes.
In special embodiments, the customized conductor elements (optionally in addition to implant-specific surface structures described above) ensure a unique connection of the surgical conductor to a patient-specific implant. Namely, it is provided that a unique connection between the implant and the conductor can be ensured by adapting the conductor elements to the implant according to the predetermined surgical schedule. Accordingly, in special embodiments, the unique connection is ensured by the conductor elements or a combination of conductor elements and implant-specific surface structures. In special embodiments, the unique connection between the implant and the conductor is ensured by at least 30% of the total contact surface (ie including implant-specific surfaces and conductor elements) between the conductor and the implant, more particularly by at least 50 % of the total contact area, more particularly by at least 75% of the total contact area. In special embodiments, the unique connection is ensured by 95 to 100% of the total contact surface of the conductor element.
As determined by the nature of the implant, the conductors are placed on the one or more surface structures and / or on the connecting structure. Elements of the connecting structure that ensure the connection of one or more conductor elements to the rest of the surgical conductor are also referred to herein as "bridge elements".
The one or more conductor elements are placed either on the one or more surface structures or on the one or more connecting structures (as further described herein) such that a surgical instrument that passes through the one or more conductors can connect to the bone or the joint at a desired location. The position of the one or more conductor elements is also such that it allows the insertion of a surgical instrument. In specific embodiments, the directions of the one or more conductor elements intersect each other such that all conductor elements can be placed within the available work space and / or the surgical window.
In particular embodiments, the one or more conductor elements of the custom-made surgical conductors of the invention may comprise one or more locking elements, which help to ensure a specific and stable connection to the patient-specific implant. In special embodiments, this locking element comprises an extension of the conductor element that fits into the screw hole of the implant, while the insertion of the surgical instrument is still possible, as shown for example in Figure 4. In further special embodiments, the conductors of the present invention is not a specific (ie independent) locking element. In further particular embodiments, the surgical guides of the invention do not include a specific locking element on a guide element.
As mentioned above, according to specific embodiments, the surgical conductors of the present invention may comprise one or more connecting structures that directly or indirectly connect the one or more surface structures to the one or more conductor elements in the custom-made surgical conductors of the invention.
The one or more connecting structures of the surgical guides according to the present invention must be sufficiently rigid to ensure the desired stability and accuracy when using the guide, but must nevertheless be as open as possible for visual inspection by the surgeon of the allow proper connection of the surgical conductor. Accordingly, in particular embodiments, the one or more connecting structures of the surgical guides according to the present invention ensure a mechanically rigid but (from a utilitarian point of view) versatile connection between the one or more surface structures and the one or more conductor elements in the customized surgical conductors, such that the position of the different components of the conductor relative to each other is fixed.
Similar to the surface structures described above, the one or more connecting structures included in the tailor-made surgical guide according to the invention can have one or more of the following functions. In addition to the purpose of interconnecting the one or more surface structures and the one or more conductor elements, the one or more connecting structures may serve as a base or supporting structure for one or more conductor elements. In addition or alternatively, the one or more connecting structures may help to ensure a specific connection to the patient-specific implant.
As will be explained in detail below, where the tailor-made surgical guide according to the invention is a tailor-made guide for a patient-specific acetabular implant, the one or more connecting structures may comprise a ring structure that is designed to specifically conform to to close on the acetabular border of the patient-specific implant. The one or more connecting structures further include bridging structures which ensure the connection of one or more conductor elements for guiding surgical aids in the acetabular cup with the rest of the surgical conductor.
In further particular embodiments, the one or more connecting structures of the custom-made surgical guides of the invention comprise one or more locking elements, which ensure additional coupling with the patient-specific implant. Where the one or more connecting structures comprise a circular ring designed to connect with an acetabular edge of an acetabular implant, such locking elements may be located on the ring structure to engage a coupling with the acetabular edge of the patient-specific implant. to ensure. However, as explained in detail above, in particular embodiments, the surgical guides of the present invention do not include a locking element, more particularly, do not include a locking element on the connecting structure.
The tailor-made surgical guides of the present invention may further comprise one or more elements for visual reference, to solve orientation problems in the case of complex shaped guide elements. These visual references may optionally be attached to the surgical guides to provide (visual) feedback to the surgeon, more particularly in the case of drill conductor elements with covering soft tissue, minimizing a potentially misinterpretation due to covered anatomical reference points, or potentially confusing orientations of the surface structures of the customized conductor. Such visual references may include, for example, a reference disk (20), as shown in Figures 2E and 4, whereby the plane formed by the disk is perpendicular to the planned drilling direction. In addition or alternatively, the tailor-made conductor according to the present invention may further comprise one or more elements, such as wing elements (22), given as an example in Figure 5, or flat discs, which indicate the direction and / or position of the one or more indicate drilling guide elements of the guide and thus also serve as a visual reference. Such visual references can be attached to a drill conductor element or any other part of the customized conductor.
In a further aspect, the present invention provides combinations of a patient-specific bone implant and a custom-made surgical guide according to the invention (as described above). Namely, the object of the present invention is to provide a tailor-made surgical guide that specifically fits a patient-specific bone implant. Accordingly, since the surgical conductor is designed to connect specifically to the bone implant, the implant and the conductor are provided as a combination. In specific embodiments of combinations of a patient-specific bone implant and a custom-made surgical guide according to the invention (ie wherein one or more of the surface structures comprises an implant-specific region) when one or more implant-specific regions of the one or more surface structures are contacted or placed opposite their corresponding complementary surfaces of the patient-specific bone implant, the surfaces fit together, they fit in and / or make contact with each other, thereby fixing the conductor in a predetermined position. This position is unique to the patient-specific implant, and since the patient-specific implant in turn has a unique position in the bone, the tailor-made guide has a unique position in the bone.
The tailor-made surgical guides according to the invention are provided for use with different types of bone implants. The surgical guides of the present invention are of particular interest for use in the attachment of bone implants in the context of complex bone reconstruction, i.e. where bone loss is observed. Thus, the conductors of the present invention are particularly suitable for implants that replace inadequate or missing bone structures. The surgical guides of the present invention are also of particular utility where a limited surgical window is / can be used. However, the custom-made surgical guides of the present invention can be designed for any patient-specific implant. The use of patient-specific implants has a number of advantages compared to traditional ready-made implants. They ensure a better and tighter anatomical connection that results in better stability and / or function (less aseptic loosening) and reduced damage to neighboring tissue. The time required for the surgeon to install (operating time) is reduced. For special applications (such as in Cranio-Maxillo Face Surgery), moreover, patient-specific implants ensure a more satisfactory aesthetic result for the patient. Patient-specific implants are generally used in orthopedic surgery of the knee, hip and shoulder, but the custom-made surgical guides according to the invention are also suitable for use in combination with patient-specific implants for other joints or bones. Accordingly, the combinations according to the present invention are not limited by a specific type of patient-specific implant.
In particular embodiments, the combination of a custom-made surgical guide and a patient-specific implant according to the invention is a combination of a patient-specific acetabular implant and a custom-made surgical guide therefor. As explained in detail above, the customized surgical conductor for an acetabular implant typically comprises one or more connecting structures comprising a ring structure, and the at least one or more surface structures of the conductor are designed to be on one or more surfaces of the patient. specific acetabular implant. Typically, a patient-specific acetabular implant comprises one or more extensions that are designed for placement on one or more of the ischium, the ilium and / or the pubis. In particular embodiments, the corresponding tailor-made surgical guide comprises one or more surfaces designed to fit on the one or more extensions of the implant. In a further particular embodiment, the tailor-made surgical guide comprises one surface structure that is designed to fit an extension of a patient-specific implant that fits on ilium.
The combinations according to the invention comprise, in addition to a patient-specific implant, a tailor-made surgical guide according to the invention. Accordingly, the customized surgical conductor comprises at least one or more surface structures, and one or more conductor elements. Optionally, and as described in detail above, the custom-made surgical guide for use in combination with the corresponding patient-specific implant comprises one or more interconnecting structures interconnecting the one or more surface structures and the one or more conductors.
In particular embodiments of the combinations comprising a patient-specific bone implant and a custom-made surgical guide according to the invention, the one or more surface structures and / or the one or more conductor elements and / or the connecting structure of the custom-made surgical conductors comprise one or more locking elements, which can be integrated into the surface structures or the connecting structure and / or which can be extensions of the one or more conductor elements and which ensure an (extra) specific coupling with the patient-specific implant. In particular embodiments, the surgical guides of the present invention do not include specific locking elements, more particularly, they do not include extensions such as those described above.
In further particular embodiments of the combinations according to the invention, the one or more conductor elements of the customized surgical conductors are drill conductor elements (or even cutting conductor elements). In further particular embodiments, the guide elements further comprise a plug, such as a drill plug.
Particular embodiments of the combinations of the present invention include a patient-specific implant and two or more custom-made surgical guides.
As explained in detail above, the customized surgical guides and combinations thereof with patient-specific implants according to the present invention are suitable for use in any type of bone or joint surgery procedure, such as, for example, bone or joint replacement surgery and / or bone or joint reconstruction surgery. Some non-limiting examples of joints where patient-specific implants can be used, and thus where custom-made surgical guides and combinations thereof with patient-specific implants according to the present invention can be used, include the hip joint (acetabulofemoral joint) between the thigh and acetabulum of the pelvis, shoulder joints (such as the glenohumeral joint between the upper arm and the lateral scapula), the wrist joint (or radiocarpal joint) between the radius and the carpus, the elbow joints (such as the humeroulnary joint between the ulna and the humerus), the knee joints (the femoral patellar joint between the patella and the femur or the femorotibial joints between the femur and tibia), and the ankle joint (or talocrural joint) between the tibia and the fibula. Non-limiting examples of bone surgery procedures where custom-made surgical guides and their combinations with patient-specific implants according to the present invention can be used include intercalar sections, plating (osteosynthesis), epiphysis of long bones, diaphysis of long bones , treatment of shattered fractures, and arthrodesis.
Accordingly, the customized surgical guides and combinations with patient-specific implants of the present invention can be used in any type of bone or joint surgery procedure for the treatment of a variety of bone and / or joint diseases, including, but not limited to, osteoarthritis, rheumatoid arthritis, avascular necrosis, osteonecrosis, congenital diseases, dislocation of a joint, joint dysplasia, stuck shoulder, loose shoulder, traumatized and affected joint, and joint stiffness. patient-specific implants used in the treatment of acetabular bone deficiencies. More specifically, the conductors are of interest for use in acetabular defects that are optimally treated with patient-specific implants, such as those classified as type 3 or 4 deficiencies according to the AAOS classification (D'Antionio et al. 1999, Clin Orthop. Rel. Res., 243: 126-137) or as type IIIb according to the Paprosky classification (Paprosky et al. 1994, J. Arthroplasty 9 (1): 33-44).
In a further aspect, the present invention provides methods for the manufacture of customized surgical guides for patient-specific bone implants.
In particular embodiments, the methods for manufacturing a customized surgical conductor for surgical instruments for placement on a patient-specific bone implant according to the invention include the steps of producing a customized surgical conductor wherein the one or more conductor elements of the are positioned in accordance with the pre-operatively planned screw paths, and / or the one or more customized surface structures of the conductor ensure a unique connection between the patient-specific bone implant and said conductor due to congruence and / or complementarity between said customized surface structure and the patient-specific morphology of said patient-specific bone implant.
In further special embodiments, this conductor is made by an additive production technique based on a design produced on the basis of pre-operative planning. Thus, in particular embodiments, the methods of the invention comprise: (a) designing a custom-made surgical guide comprising one or more custom-made guide elements and one or more custom-made surface structures based on: - an image of the bone and the bone patient-specific bone implant on it; - one or more thread inserts determined by pre-operative planning (b) producing, by an additive production technique of said surgical conductor based on the design obtained in step (a), wherein: - the one or more conductor elements of said conductor are placed are in accordance with the pre-operatively planned screw paths, and - the one or more customized surface structures of said conductor ensure a unique connection between the patient-specific bone implant and said conductor through the congruence between said customized surface structure and the patient's specific morphology of said patient-specific bone implant.
In further particular embodiments, the methods for manufacturing customized surgical guides according to the invention comprise the steps of: (a) obtaining an image of the bone and the patient-specific implant thereon; (b) determining one or more screw inserts using a schedule; (c) designing a customized surgical conductor such that - the conductor elements are positioned in accordance with the predetermined screw paths, and - one or more surface structures provide a supporting structure that connects the one or more conductor elements and fits in a unique way on the patient-specific bone implant.
(d) producing said surgical guide based on the information provided in step (c).
Accordingly, the methods for manufacturing the custom-made surgical guides of the invention include the step of obtaining an image of the bone on the patient-specific implant on it. Digital patient-specific image information can be provided in any suitable manner known in the art, such as for example a computed tomography (CT) scanner, a magnetic resonance (MRI) scanner, an ultrasonic scanner, or a combination of X-rays. A summary of medical imaging is described in "Fundamentals of Medical Imaging", by P. Suetens, Cambridge University Press, 2002.
For example, the step of obtaining an image of the bone and the patient-specific implant on it may include the steps of (a1) obtaining 2D data sets from the bone and (a2) reconstructing a 3D virtual bone model from said 2D data sets . The first step in planning is the construction of a 3D virtual model of the bone. This reconstruction begins with sending a patient to a radiologist for scanning, e.g. for a scan that produces medical volumetric data, such as a CT, MRI scan or the like. The output of the scan can be a stack of two-dimensional (2D) slices that form a 3D dataset. The output of the scan can be digitally entered into a computer program and can be converted using algorithms that are known in the field of image processing technology to create a 3D computer model of a relevant bone. Preferably, a virtual 3D model is constructed from the dataset using a computer program such as Mimics ™ as supplied by Matérialisé N.V., Leuven, Belgium. Parameters of the computer algorithm are based on accuracy studies, as described for example by Gelaude at al. (2008; Accuracy assessment or CT-based outer surface fémur meshes Comput. Aided Surg. 13 (4): 188-199). A more detailed description for making a perfected model is disclosed in U.S. Patent No. 5,768,134 entitled "Method for making a perfected medical model on the basis of digital image information or a part of the body".
Once the 3D volume of the bone has been reconstructed, the surgeon (or practitioner) can determine the position of the implant and the designated position, orientation, depth and diameter of the screw paths using a schedule that can be used to to attach the implant to the bone. In non-limiting embodiments of the methods for the manufacture of custom-made surgical guides according to the invention, the locations and / or the directions of the one or more screw inserts are determined by a planning procedure, which is performed pre-operatively. Alternatively, a planning procedure in the methods for manufacturing the conductors during the operation / surgery can be performed without having performed a pre-operative planning step. The planning of the surgical intervention is done with the help of suitable specially designed software, based on suitable medical images (of which CT, MRI, examples), taking into account factors such as bone quality and proximity of nerve bundles / blood vessels or other anatomical sensitive items. To plan and simulate the intervention, the images are entered into a computer workstation running 3D software. These images are manipulated as a 3D surface grid. The result is a computer simulation of the intervention, which yields a schedule that contains the information necessary to adjust the orientation of the conductors.
In specific embodiments of the methods for manufacturing customized surgical guides according to the present invention, the step of determining one or more screw paths includes taking into account one or more of the following criteria: - obtaining an optimum number non-intersecting drilling directions for the screw paths; - ensuring that the screw paths run through bone volume with the most optimal available quality; - ensuring the optimum length of the screw conveyor; and - ensuring that the surrounding healthy soft tissue is optimally preserved.
Accordingly, the step of determining one or more screw paths may include obtaining an optimum number of non-intersecting drilling path directions for screw paths. To obtain an optimal (which may imply a maximum) number of non-intersecting screw paths, a planning is performed by geometrically analyzing the bone and the patient-specific implant. As a result, all screws for which screw holes were provided in the schedule can be placed during surgery. The number of screws is limited to the number that is actually used. Providing more screw holes than necessary would weaken the implant in terms of long-term fatigue, and would increase the size of the implant. The latter would imply unnecessary sacrificing of healthy neighboring soft tissues.
The step of determining one or more screw paths may further include ensuring that the screw paths run through bone volume with the most optimal (which may imply the best) available quality. Therefore, the planning is performed by analyzing the bone and the patient-specific implant geometry, and the gray values obtained from the medical images. As a result, the screws are surrounded by bone with an optimum tensile strength.
Moreover, the step of determining one or more screw paths may further include ensuring that an optimum (which may imply a maximum) length of the screw path is determined. Therefore, planning is performed by analyzing the bone and patient-specific implant geometry, and the presence of implant components from previous operations being maintained. Consequently, screws have a practical and sufficient length to be useful and effective.
Finally, the step of determining one or more screw paths may further include ensuring that the surrounding healthy soft tissue is optimally preserved (which may imply maximally). Therefore, a planning is performed by analyzing the soft tissue.
The process of directly determining the location of the screws relates to the size of the surface of the patient-specific implant that covers the bone through which the screws will be inserted. In the light of a post-operative restoration of a patient's functionality, the screws that protrude into (healthy) soft tissues - or implant portions that cover (healthy) soft tissues - should be avoided as much as possible as in the case of muscle attachments, or it is simply impossible, as in the case of nerves and blood vessels.
The foregoing criteria for adequately determining one or more screw paths can be applied separately or, on the other hand, can be combined. For example, the criterion of ensuring that the screw paths run through bone volume with the most optimal available quality, and the criterion of ensuring that an optimum (which may imply a maximum) length of the screw path is determined, is combined, resulting in in finding that screw paths that run through bone volume with good bone quality but that are small in length (ie a small bone depth) are useless. For example, in normal patients, the center of the iliac wing consists of a double layer of strong cortical bone, although the trajectory length that can be determined measures less than about 2 mm and therefore renders this place for screw placement impractical.
Also the criterion for ensuring that the screw paths run through bone volume with the most optimal (which may imply the best) available quality can be combined with the criterion of ensuring that an optimum (which may imply a maximum) becomes the length of the screw path as well as the criterion of ensuring that the surrounding healthy soft tissue is optimally preserved. For example, when determining the surface of the patient-specific acetabular implant covering the ilium, an overlap with the gluteal medial muscle is preferably avoided.
Moreover, during the planning of determining one or more screw paths, the criterion of obtaining an optimum number of non-intersecting drilling directions for screw paths can be combined with the criterion of ensuring that the screw paths run through bone volume with the optimum available quality as well as with the criterion of ensuring that an optimal (which may imply a maximum) length of the screw path is determined and with the criterion of ensuring that the surrounding healthy soft tissue is optimally preserved.
When the preferred position, orientation, depth and diameter of the screw paths were determined, this information can be used to design the tailor-made surgical guide that fits perfectly when placed on the implant.
Designing a tailor-made surgical guide according to the invention to fit a patient-specific bone implant involves ensuring that the guide elements are placed in accordance with the predetermined screw inserts and that one or more surface structures provide a supporting structure that provides the one connect more or more conductor elements and uniquely fit (and, where appropriate, specific) to the patient-specific bone implant.
A preferred method for designing the surgical template uses a computer program such as 3-matic ™ as supplied by Matérialisé N.V., Leuven, Belgium. Alternatively, the surgical guide is produced automatically based on information about the preferred position, orientation, depth, and diameter of the screw paths. In a particular non-limiting embodiment, this method uses a number of design parameters as input including, but not limited to, the dimensions of the surgical aids as used by the physician, the surgical conductor's contact area with the patient-specific implant at the positions where the surgical device is to be placed, etc.
More specifically, the step of producing the custom-made surgical guide according to the invention involves producing and assembling its various parts, ie producing one or more surface structures (as described herein), one or more conductor elements (such as described herein), and optionally one or more connecting structures (described herein) interconnecting the different parts of the conductor.
More specifically, the step of producing the customized surgical guide according to the invention involves positioning the one or more surface structures (as described herein), the one or more conductor elements (as described herein), and optionally, the one or more connecting structures (as described herein) that the conductor fits perfectly and in a unique way (ie only in that position) on the patient-specific implant. The one or more surface structures of the custom-made surgical guides according to the present invention are positioned so that they can serve as a basis or as a supporting structure for the one or more conductor elements of the guides and, moreover, or alternatively, to provide the unique (and selection, specific) connection of the surgical conductors with the patient-specific implant. Namely, where the outer surface (ie, the surface opposite the surface facing the bone) of the patient-specific implant corresponds to a standard shape (or one of a selection of standard shapes), the one or more surfaces are designed to form a "single connection" insure or be able to insure (ie only one position fits) with all implants that have the same standard outer surface. Where the outer surface or external morphology of the patient-specific implant is also specific to the implant, these specific properties can be a unique connection (ie only one position fits and there is only an optimal connection only to the corresponding implant and the patient on which the based on the customized conductor on the patient-specific implant.
The position of the one or more conductor elements included in the surgical guides is determined by the planned direction of a surgical instrument in the bone or joint. As determined by the nature of the implant, the conductor elements are placed on the one or more surface structures and / or on the one or more connecting structures. The position of the one or more connecting structures of the customized surgical guides according to the invention is preferably such that, in addition to a connection between the one or more surface structures and the one or more conductor elements, a base or a supporting structure for one or more more conductor elements is provided, and / or additionally or alternatively, makes a contribution to the specific connection with the patient-specific implant.
In particular embodiments, the custom-made surgical guides according to the invention are manufactured by rapid production techniques, which are also referred to as layered production techniques or material deposition production techniques.
Fast production includes all techniques whereby an object is built up layer by layer or point by point by adding or hardening material (also called free-form production). The best known techniques of this type are stereolithography and related techniques, whereby, for example, a basin with liquid synthetic material is selectively cured layer by layer by means of a computer-controlled electromagnetic beam; selective laser sintering, wherein powder particles are sintered by means of an electromagnetic beam or fused together according to a specific pattern; Fused Déposition Modeling, in which a synthetic material is melted and stacked according to a line pattern; the production of laminated objects, in which layers of glue-covered paper, plastic, or metal laminates are successively glued together and cut to a shape with a knife or a laser cutter; or electron beam melting, wherein metal powder is melted layer by layer with an electron beam in a high vacuum.
In particular embodiments, Rapid Prototyping and Manufacturing (RP&M) techniques are used to produce the custom-made surgical guides of the invention. Rapid Prototyping and Manufacturing (RP&M) can be defined as a group of techniques used to quickly produce a physical model of an object, typically using three-dimensional data for (3-D) computer assisted design (CAD) of the object. A large number of Rapid Prototyping techniques are currently available, including stereo lithography (SLA), Selective Laser Sintering (SLS), Fused Déposition Modeling (FDM), foil-based techniques, etc.
A common feature of these techniques is that objects are typically built up layer by layer. Stereolithography, currently the most common RP&M technique, uses a barrel of liquid photopolymer "resin" to build an object layer by layer. On each layer, an electromagnetic beam, e.g., one or more laser-guided laser beams, writes a specific pattern on the surface of the liquid resin that is determined by the two-dimensional cross-sections of the object to be formed. Exposure to the electromagnetic beam cross-linked, or hardens, the pattern written on the resin and attaches it to the underlying layer. After a layer has been polymerized, the platform drops with a single layer thickness and a subsequent layer pattern is written, which is adhered to the previous layer. A complete 3-D object is formed by this process.
Selective Laser Sintering (SLS) uses a high-power laser or other concentrated heat source to sinter or weld small particles of plastic, metal, or ceramic powder into a mass that represents the 3-dimensional object to be formed.
Fused Déposition Modeling (FDM) and related techniques use a temporary transition from a solid material to a liquid state, usually as a result of heating. The material is pressed through an extrusion nozzle in a controlled manner and deposited at the required location as described, inter alia, in U.S. Patent No. 5,141,680.
Foil-based techniques attach layers to each other by gluing or photopolymerization or other techniques and cut the article from these layers or polymerize the article. Such a technique is described in US Patent No. 5,192,539.
Typical RP&M techniques start from a digital representation of the 3-D object to be formed. In general, the digital representation is cut out as a series of cross-sectional layers that can be superimposed to form the object as a whole. The RP&M device uses this data to build the object on a layer-by-layer basis. The cross-sectional data representing the layer data of the 3-D object can be produced using a computer system and computer-assisted design and production software (CAD / CAM).
A Selective Laser Sintering (SLS) device is used in special embodiments for the manufacture of the customized surgical tool based on a computer model. It should be understood, however, that different types of rapid production techniques can be used to accurately manufacture custom-made surgical guides including, but not limited to, stereolitography (SLA), Fused Deposition Modeling (FDM), or freezing. Also, the conductors of the present invention can be similarly manufactured using other methods, notwithstanding rapid prototype methods, are particularly suitable in the context of the present inventions.
The surgical guides according to the invention can be made from different materials. Typically only materials are considered that are bio-compatible (eg USP class VI compatible) with the human body. Preferably, the tailor-made surgical conductor is formed from a material that can tolerate heat allowing it to tolerate high temperature sterilization. In case SLS is used as an RP&M technique, the surgical mold can be made from a polyamide such as PA 2200 as supplied by EOS, Munich, Germany or any other material known to those skilled in the art can also be used.
The invention further provides computer programs for performing the production methods of the present invention. More specifically, the present invention provides computer program products for allowing an apparatus to perform at least a portion of the methods of the invention described herein.
In particular embodiments, computer programs are provided for providing a design of a custom-made surgical conductor comprising one or more custom-made conductor elements and / or one or more! customized surface structures based on (1) one or more images of the bone and the patient-specific bone implant thereon respectively; and (2) one or more screw paths determined by the pre-operative planning. In particular embodiments, the one or more conductor elements of the conductor are positioned in accordance with the preoperatively planned screw insertions. In addition or alternatively, the one or more customized surface structures of the conductor are designed to ensure a unique connection between the patient-specific bone implant and the conductor by means of a congruence or complementarity between the customized surface structure (structures) and the patient -specific morphology of the patient-specific bone implant.
In further particular embodiments, the computer programs further ensure the production of the surgical guide according to the invention by an additive production device. Suitable devices for manufacturing the conductors of the present invention are known to those skilled in the art and are explained in detail above.
A further aspect of the invention relates to the use of the custom-made surgical guides described herein to ensure stable attachment of the patient-specific implant. According to this aspect, the present invention provides methods for attaching a patient-specific bone implant to a bone, which in particular embodiments comprises the steps of: (a) placing a custom-made surgical guide according to the invention on a patient-specific bone implant provided in the body; (b) introducing the screw paths with the designated surgical tools; (c) removing said custom-made surgical guide; and (optionally) (d) attaching the patient-specific bone implant to the bone with screws.
In particular embodiments, for example, when self-tapping screws are used, the screw paths are determined after the insertion of the screws in step (b). This can ensure the attachment of the implant to the bone such that step (d) is no longer or only partially required. In further special embodiments, combinations of fasteners are used.
More specifically, the step of placing a custom-made surgical guide according to the invention on a patient-specific bone implant implies that the custom-made surgical guide is placed on the patient-specific bone or joint implant such that it fits, couples, coincides and / or connects with the (specific) elements of the patient-specific implant.
The methods according to this aspect of the invention further include the step of introducing the different screw paths with the designated surgical aids. As described above, this includes, but is not limited to, a pilot, drill, saw, jigsaw, mill, or lateral drill, and fasteners such as a screw. Based on the position of the conductors (and optionally the stop provided therein), a designated screw path is provided.
The methods of attaching the patient-specific bone implant to a bone according to the invention further include the step of removing the customized surgical guide. This step can be performed either before or after the implant is attached to the bone. According to particular embodiments, after the screw paths have been introduced, the surgical guide is removed to allow definitive attachment of the patient-specific implant to the bone or joint. Alternatively, the implant is first attached to the bone and the conductor is then removed. The methods of the present invention have the advantage that the patient-specific implant is already in place within the sometimes very narrow and deep surgical window, is maintained during the introduction of the screw paths, and does not have to be removed prior to attachment.
Accordingly, the methods of attaching the patient-specific bone implant to a bone further, either before or after removal of the custom-made surgical guide, include the step of (partially) securing the patient-specific bone implant with screws on the bone or the joint. Devices for carrying out a fastening with screws are known to the skilled person.
The invention is further illustrated below by means of the following non-limiting embodiments.
In particular embodiments, the invention is used for the replacement of an acetabular head and the custom-made surgical guides of the present invention are designed to fit a patient-specific acetabular implant. According to these embodiments, the connecting structure can be a ring structure and the at least one or more surface structures are designed to fit on one or more surfaces of the patient-specific acetabular implant. For example, in these embodiments, the one or more surfaces of the patient-specific acetabular implant may be designed based on specific anatomical elements of one or more of the ilium, ischium and / or pubis of the hip joint.
In particular embodiments, the present invention provides customized surgical conductors for a patient-specific acetabular implant comprising one or more surface structures, and one or more conductor elements, wherein at least one of said one or more surface structures is designed to fit on the patient. specific acetabular implant. The acetabulum is the cup-shaped joint socket of the hip in which the femur head moves. In general, a joint prosthesis consists of a convex component that moves in a concave cup, such as, for example, in hip joint arthroplasty, a femur head is attached to a stem moving in an acetabular head. The following section further describes the invention by means of the specific embodiment of a customized surgical guide for a patient-specific acetabular implant as illustrated in Figures 1 to 3.
The patient-specific acetabular implant according to the embodiment described herein comprises a hemisphere-shaped cup tightly connected to the host bone with patient-specific surfaces that provide close contact between the implant and the ilial, ischial and pubic host bones. Figure 2A depicts a severe acetabular defect of the left hemi pelvis (1) to be treated with the patient-specific acetabular implant (2). A customized conductor (3) according to the present invention as shown in Figures 1, 2C, 2D and 2E and 3 is designed to fit on the implant (2) to guide planned drilling directions (4) for the screws that are in a planned direction through the implant screw holes (12) will be inserted. The tailor-made surgical guide (3) for a patient-specific acetabular implant consists of a central ring structure (5) that couples to the acetabular edge (13) of the acetabular implant (2) as shown in Figures 2B, 2C and 2D . The custom-made surgical guide for the acetabular implant according to the present embodiment comprises one or more surface structures (7), (8) and (9), which comprises at least one implant-specific region of the external morphology allowing the correct placement of the conductor is insured on the patient-specific implant. As shown in Figures 1 and 3, the one or more of the surface structures (7), (8), and (9) extend from the central ring (5) and include the one or more implant-specific regions that be completely complementary with the patient-specific areas (17), (18) and (19) of the external morphology of the acetabular implant. The side of each of these three surface structures that face the bone is specifically designed to fit anatomical elements of each of the ilium, ischium, and pubis, respectively. As shown in Figure 2B, the patient-specific regions of the external morphology (17), (18) and (19) of the acetabular implant (2) comprise one or more screw holes (12). The one or more locking elements (6) on the central ring (5), as shown in Figures 1 and 2D, add translational stability by preventing the sliding of the customized guide (3) in the plane of the acetabular edge (13). These locking elements (6) still allow the application of customized conductor (3) to the patient-specific implant (2). Rotational stability, either unidirectional or bi-directional, results mainly from the unique curved connection of the contact area with the one or more surface structures (7), (8), and (9) and the patient-specific implant (2) . Rotational stability can be further improved by adding locking elements located on the surface structures (7), (8), and (9) of the custom-made conductor, which couple with the corresponding locking elements present in the patient-specific implant ( 2). Figures 1 and 3 show cylindrical drill guide elements (10) located on the surface structures of the custom-made guide (3) according to this specific embodiment for inserting a pilot drill instrument at the location of the implant screw holes (12) present in the surface structures (7), (8), and (9). In this specific embodiment, the predrilled screw holes are intended / suitable for cortical screws. Further, additional (cylindrical drill) guide elements (11) (shown in Figure 3) are located on or within the cavity formed by the acetabular portion (14) (shown in Figure 2B) of the patient-specific implant (2), which is secured by bridging structures (21) (shown in Figure 3) to the central ring (5) to guide the insertion of a pilot drill instrument at the location of the implant screw holes present in the acetabular portion (14). In this specific embodiment, the predrilled screw holes are intended / suitable for trabecular screws. In some embodiments, a portion of drill guide elements (11) may be located below the level of the plane formed by the acetabular edge (13) of the patient-specific implant (2). In general, cylindrical drill guide elements (10) and (11) can intersect with each other to provide guidance and to allow drilling within the available work space. In the present example, this is the case for the cylindrical drill guide element (11) in the cavity formed by the acetabular portion (14) of the implant (2) to allow drilling from within the available surgical window.
The diameter of the cylindrical drill guide elements (10) and (11) is determined based on the diameter of the pre-drilling tool, while the height is determined to provide sufficient stability and / or guidance to the same tool. The cylindrical drill guide elements (10) and (11) can also be adjusted with either a straight, slanted or with a complex shaped cut to fit into the surgical window. To solve visual orientation problems in the case of obliquely customized cylinders, a disc-shaped visual reference ring (20), as shown in Figure 2E, can be added to the base of the bore conductor cylinders (10) and (11) to provide visual feedback to the surgeon. The plane that is normally on the disc (20) is the same as the planned drilling direction (4). As an additional or alternative visual reference, a wing member (22) as shown, for example, in Figure 5 can be provided in the case of drill guide members with overlying soft tissue. The wing is, for example, attached to a drill guide element (10) or (11), or at another location of the customized guide (3). The wing element provides visual feedback to the surgeon, which minimizes potential misinterpretation due to unclear anatomical reference points, or potentially confusing orientations of the surface structures (7), (8) and (9) of the customized conductor (3) ).
In the present embodiment, a cylindrical drill guide element can be halved lengthwise, as illustrated by the halved cylindrical drill guide element (23) in Figure 6, which allows a (partial) insertion of a screw directly into the implant, and then removal of the customized conductor with the inserted screw fixed in place. By doing this, the number of degrees of freedom of the patient-specific implant (2) and the customized guide (3) during drilling diminishes, and it is ensured that the correspondence between the predrilling and the screw holes is not lost. In the present embodiment, the cylindrical guides (10) and (11) may include an extension (16), shown in Figure 4, in the screw hole of the implant, while the pre-drilling instrument can still be inserted. By doing this, the number of degrees of freedom of the customized conductor (3) relative to the patient-specific implant (2) is reduced. This is an example of an additional locking element between the conductor and the implant.

权利要求:
Claims (16)
[1]
A custom-made surgical guide (3) for surgical instruments for placement on a bone implant with a patient-specific external morphology (2), the custom-made surgical guide comprising: (i) one or more custom-made surface structures (7, 8, 9) extending over at least a portion of the external patient-specific morphology of the implant, and (ii) one or more customized conductor elements (10, 11), wherein said customized surgical conductor and contacting said bone implant by means of a unique connection ensured by the correspondence between said patient-specific external morphology of said bone implant and at least one of said one or more customized surface structures.
[2]
The custom-made surgical conductor of claim 1, wherein said unique connection is further ensured by the position and orientation of the custom-made conductor elements.
[3]
The custom-made surgical guide according to claim 1 or 2, which was made by additive manufacturing techniques.
[4]
The custom-made surgical conductor according to any of claims 1 to 3, further comprising one or more connecting structures, interconnecting said one or more surface structures and said one or more conductors.
[5]
The custom-made surgical conductor of claim 4, wherein said one or more connecting structures comprises one or more locking elements.
[6]
The custom-made surgical guide according to any of claims 1 to 5, wherein said custom-made surgical guide further comprises an element that serves as a visual reference for performing a surgical interaction.
[7]
The custom-made surgical conductor according to any of claims 1 to 6, wherein said one or more conductor elements comprises a drill conductor element.
[8]
The custom-made surgical conductor according to any of claims 1 to 7, wherein said one or more conductor elements comprises a cutting conductor element.
[9]
The custom-made surgical guide according to claim 7 or 8, wherein said one or more cutter or drill guide elements further comprises a cutter or drill stop.
[10]
The custom-made surgical conductor of any one of claims 1 to 9, wherein said patient-specific bone implant is an acetabular implant, wherein (i) said connecting structure is a ring structure that fits on the acetabular edge of said acetabular implant; and (ii) said custom-made surgical guide and said patient-specific acetabular implant fit together in a unique manner, ensured by the congruence between said patient-specific external morphology of said acetabular implant and at least one of said one or more on custom surface structures.
[11]
A customized surgical conductor for surgical instruments, for placement on a patient-specific acetabular bone implant, the customized surgical conductor comprising: (i) one or more customized surface structures extending over at least a portion of the surface of the implant, and (ii) one or more custom-made conductors, (iii) a connecting structure connecting said one or more surface structures and said one or more conductor elements that is a ring structure that fits on the acetabular edge of said acetabular implant, and wherein said customized surgical guide and said patient-specific bone implant fit together in a unique manner, ensured by the congruence between said patient-specific implant and at least one of said one or more customized surface structures.
[12]
A method for manufacturing a customized surgical conductor for surgical instruments, for placement on a patient-specific bone implant according to any of claims 1 to 11, comprising the steps of: (a) designing an op custom-made surgical conductor comprising one or more custom-made conductor elements and one or more custom-made surface structures based on: - an image of the bone and the patient-specific bone implant thereon, - one or more screw insertions determined by pre-operative planning, (b) producing said tailor-made surgical guide based on the design obtained in step (a), wherein: - the one or more conductor elements of said conductor are placed in accordance with the preoperatively scheduled screw insertions, and - the one or more customized surface structures of said conductor ensure a unique connection between the patient spec optional bone implant and said conductor due to the congruence between said tailor-made surface structure and the external patient-specific morphology of said patient-specific bone implant.
[13]
The method of claim 12, wherein said step of determining one or more screw paths using a schedule comprises taking into account one or more of the following criteria: - obtaining an optimum number of non-intersecting drilling directions for screw conveyors; - ensuring that said screw paths run through bone volume with the optimum available quality; - ensuring the optimum length of the screw conveyor; and - ensuring that the surrounding healthy soft tissue is optimally preserved.
[14]
A tailor-made surgical guide for a patient-specific bone implant obtainable by a method according to any of claims 12 or 13.
[15]
A combination of a patient-specific bone implant and a custom-made surgical guide according to any of claims 1 to 11 or claim 14.
[16]
A method for attaching a patient-specific bone implant to a bone, comprising the steps of: (a) placing a customized surgical guide according to any of claims 1 to 11 or claim 14 on a patient-specific bone implant; (b) introducing screw conveyors with the designated surgical tools; and (c) removing said custom-made surgical guide; and (d) attaching the patient-specific bone implant to the bone with one or more screws; wherein step (d) in said method can take place either before or after step (c), or in both cases.

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同族专利:

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公开号 | 公开日

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CA2782117C|2018-09-11|

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EP2853206A1|2015-04-01|

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US9808261B2|2017-11-07|

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EP2519165B1|2015-02-11|

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DK2519165T3|2015-05-26|

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CA2782117A1|2011-07-07|

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EP3251619A2|2017-12-06|

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EP2519165A1|2012-11-07|

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JP2013515578A|2013-05-09|

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WO2011080260A1|2011-07-07|

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AU2010338263A1|2012-07-19|

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JP6985041B2|2021-12-22|

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JP2017196486A|2017-11-02|

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AU2010338263A2|2012-07-19|

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JP6196446B2|2017-09-13|

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EP3251619A3|2018-05-23|

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GB0922640D0|2010-02-10|

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US20120289965A1|2012-11-15|

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AU2010338263B2|2013-09-12|

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法律状态:

优先权:

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申请号 | 申请日 | 专利标题

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GBGB0922640.8A|GB0922640D0|2009-12-29|2009-12-29|Customized surgical guides, methods for manufacturing and uses thereof|

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GB0922640|2009-12-29|

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