WO2014177894A1 - Guide chirurgical - Google Patents

Guide chirurgical Download PDF

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Publication number
WO2014177894A1
WO2014177894A1 PCT/GB2014/052023 GB2014052023W WO2014177894A1 WO 2014177894 A1 WO2014177894 A1 WO 2014177894A1 GB 2014052023 W GB2014052023 W GB 2014052023W WO 2014177894 A1 WO2014177894 A1 WO 2014177894A1
Authority
WO
WIPO (PCT)
Prior art keywords
spacing component
surgical guide
component
tissue surface
spacing
Prior art date
Application number
PCT/GB2014/052023
Other languages
English (en)
Inventor
Andrew Dawood
Alister Hart
Original Assignee
Andrew Dawood
Alister Hart
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Andrew Dawood, Alister Hart filed Critical Andrew Dawood
Publication of WO2014177894A1 publication Critical patent/WO2014177894A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
    • A61B17/1739—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
    • A61B17/1742—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the hip
    • A61B17/1746—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the hip for the acetabulum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/14—Surgical saws ; Accessories therefor
    • A61B17/15—Guides therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4603—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2/4609—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof of acetabular cups
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B2017/568—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor produced with shape and dimensions specific for an individual patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
    • A61B2034/101—Computer-aided simulation of surgical operations
    • A61B2034/102—Modelling of surgical devices, implants or prosthesis
    • A61B2034/104—Modelling the effect of the tool, e.g. the effect of an implanted prosthesis or for predicting the effect of ablation or burring
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
    • A61B2034/101—Computer-aided simulation of surgical operations
    • A61B2034/105—Modelling of the patient, e.g. for ligaments or bones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
    • A61B2034/108—Computer aided selection or customisation of medical implants or cutting guides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2002/4632—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor using computer-controlled surgery, e.g. robotic surgery
    • A61F2002/4633—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor using computer-controlled surgery, e.g. robotic surgery for selection of endoprosthetic joints or for pre-operative planning

Definitions

  • the present application relates to a surgical guide and a method for providing a surgical guide.
  • the surgical guide is a programmable alignment jig for orthopaedic surgery .
  • holes may be drilled and the bone prepared in specific configurations and relationships for the purpose of screw insertion, joint replacement, and other bony surgical procedures where precise preparation of the bone is required.
  • 3D data derived from scanning/ imaging / modelling modalities, such as Computed Tomography (CT), Cone Beam Computed Tomography (CBCT), Magnetic Resonance Imaging (MRI) or 3D optical scanning technologies.
  • CT Computed Tomography
  • CBCT Cone Beam Computed Tomography
  • MRI Magnetic Resonance Imaging
  • 3D optical scanning technologies such as Computed Tomography (CT), Cone Beam Computed Tomography (CBCT), Magnetic Resonance Imaging (MRI) or 3D optical scanning technologies.
  • CT Computed Tomography
  • CBCT Cone Beam Computed Tomography
  • MRI Magnetic Resonance Imaging
  • 3D optical scanning technologies 3D optical scanning technologies.
  • RP Rapid Prototyped
  • patient specific physical cutting guides, drill guides, or surgical jigs may then be manufactured to constrain and guide bony preparation, so that the virtual plan may be transferred to the surgical site.
  • surgical navigation may be used to guide the surgeon at the time of surgery.
  • RP patient specific guides are currentiy available for joint replacement surgery for the knee and hip and in other surgical situations including eg. the spine and the jaws. These patient-specific guides are typically made using additive manufacturing technologies or other CAD CAM technologies. They are designed to fit precisely, or to a planned tolerance or level of precision, in a pre-planned configuration onto for example the spine, femoral head, tibia, or into the acetabulum.
  • the fitting surface is defined by a 3D data of the bony substrate, and orientation of the guiding element defined by preoperative planning in software, using 3D volumetric, or sometimes 2D, image data.
  • the present invention seeks to provide an improved surgical guide body, surgical guide and method.
  • a body for a surgical guide for being placed at a tissue surface, the body including at least one coupling element, the or each coupling element being for selectively receiving a spacing component to extend from the body whereby to seat the guide onto a tissue surface in a predetermined manner.
  • Embodiments of the invention are for use on a tissue surface, preferably a bony surface of a patient.
  • a tissue surface preferably a bony surface of a patient.
  • the bony surface may include a covering layer, such as a layer of cartilage.
  • the at least one coupling element is a plurality of coupling elements.
  • Preferred embodiments provide a guide body which can be modified by the configuration and addition of one or more spacing components in accordance with a plan derived using an associated computer program.
  • the program can determine how to configure the one or more spacing components in order to seat the guide in a precise predetermined position with respect to the tissue surface of a patient, and preferred embodiments thereby provide a quickly configurable and cost-effective patient-specific guide.
  • the plan can provide for example which of a range of spacing components should be coupled to which coupling elements and/or how individual spacing components should be trimmed or otherwise configured in order to seat the guide in the predetermined position, taking into account the structure of the tissue surface.
  • the or each coupling element can receive a spacing component in a secure manner to prevent the spacing component falling out.
  • the body includes a first surface arranged to face a tissue surface in use and the coupling elements are spaced apart and arranged to substantially cover the first surface.
  • spacing components can be selectively configured to provide a precisely controlled configuration and position to the surgical guide in accordance with the tissue surface to which the surgical guide is applied.
  • the coupling elements are substantially evenly spaced.
  • the coupling elements can be recesses or holes for receiving spacing components.
  • the body can include a main portion, and at least one spoke extending laterally or radially from the main portion, at least one of the at least one coupling element being provided on the at least one spoke.
  • One or more coupling elements can be provided on the main portion, on the at least one spoke, or on both the main portion and the at least one spoke.
  • the coupling elements on the main portion can be recesses and the coupling elements on the spoke(s) can be holes.
  • the main portion or the entire body can be bulbous whereby to fit into a recess of a tissue surface.
  • the body can include a hole to allow visualisation and/or exploration, from one side of the body, of a tissue surface on the other side of the body.
  • the body can include a holder for holding a guiding component of a guiding assembly in a predetermined relative position. This can enable a guiding component of a guiding assembly to be set up in a known configuration based on a precisely configured position of the surgical guide, enabling the surgical guide to be precisely positioned in order to provide a configuration to the guiding component in accordance with a planned surgical operation.
  • the position for the guide body can include the orientation of the guide body.
  • a kit including a body and at least one spacing component.
  • the kit can include a plurality of bodies of different sizes and/or a plurality of spacing components of different sizes and/or types. Spacing components of different types and or sizes can be provided in different colours to allow easy selection.
  • the associated computer program can therefore indicate the configuration for the spacing component for each coupling element by indicating the colour of spacing component to be placed into the coupling element. This can allow an appropriate selection to be made which is precisely tailored to a particular patient.
  • a surgical guide including a body for being placed at a tissue surface and at least one spacing component coupled to and extending from the body, the at least one spacing component being configurable whereby to seat the guide onto a tissue surface in a predetermined manner.
  • the at least one spacing component can be integral with the body.
  • the body can be as described above.
  • the at least one spacing component is configured in a predetermined manner, for example in accordance with a predetermined plan specific to an individual patient and preferably specific to an individual surgical operation.
  • the at least one spacing component is configured in accordance with a plan derived from a multi-dimensional image of a tissue surface to seat the guide onto the tissue surface in a predetermined manner.
  • the plan can be derived by or using a computer program.
  • At least one dimension of the at least one spacing component is selected to provide for the at least one spacing component to seat the guide onto a tissue surface in a predetermined manner.
  • At least one, the, or each spacing component is rigid.
  • At least one, the, or each spacing component is elongate.
  • At least one, the, or each spacing component is straight.
  • At least one, the, or each spacing component includes markings to show different trimming points for configuration of the respective spacing component.
  • the surgical component can for example be a prosthesis or a guiding component for a guiding assembly.
  • a configuration of the at least one spacing component is determined before the said configuration is applied to the at least one spacing component.
  • Determining a configuration of at least one spacing component can include determining a type and or size of the at least one spacing component and/or a position for the at least one spacing component to be coupled to the surgical guide body.
  • the method can include using a calibrated specification of the surgical guide body and a multidimensional image of the tissue surface to determine a configuration of the at least one spacing component.
  • the multi-dimensional image can include 3D data relating to a structure of the tissue surface.
  • the method can include determining a desired position of the surgical guide body with respect to the tissue surface, and determining a configuration of the at least one spacing component using the desired position of the surgical guide body and the multi-dimensional image of the tissue surface, the configuration of the at least one spacing component being determined so that the at least one spacing component extends from the surgical guide body and abuts the tissue surface to seat the surgical guide body in the desired position.
  • Determining a desired position of the surgical guide body with respect to the tissue surface can include using a desired position of a guiding component for the surgical component and a calibrated relative position of the guiding component with respect to the surgical guide body.
  • the method can include imaging, such as by scanning, the tissue surface to obtain the multidimensional image of the tissue surface.
  • the method can include making the at least one spacing component using rapid prototyping.
  • the method can include configuring the at least one spacing component in accordance with the determined configuration.
  • the method can include positioning the at least one spacing component onto the surgical guide body, for example by coupling the at least one spacing component with at least one corresponding coupling elements on the surgical guide body.
  • an executable program operable to perform the method when executed on a computing device.
  • a computing device programmed with the executable program.
  • Embodiments of the present invention relate to a surgical guiding device that may be modified or 'programmed' by the addition or subtraction of modifying accoutrements, such as pegs, studs, or screws or other suitable spacing components (SCs), which modify the fitting surface of the programmable jig so as to better fit the surgical site, and guide the surgical procedure according to a plan formulated by an associated software tool.
  • the software tool will specify the type and position of the SCs, not only to achieve the best fit to the bony site, but also to align the guiding element of the device according to the planned orientation.
  • Said SCs may be non patient specific pre-manufactured components or may be patient specific manufactured using RP technologies, perhaps by a local 3D printer.
  • Said guide is provided with connecting parts, which act as spacing components so that the guide seats onto the bony surface in a preplanned and predesignated manner, as determined by measurements or planning in computer software.
  • Said guide is provided with connecting parts, which act as spacing components so that the guide seats onto the bony surface in a preplanned and predesignated manner, as determined by measurements or planning in associated computer software.
  • spacing components are made using rapid prototyping (i.e. 3D printing, additive manufacturing, milling techniques) to closely adapt the guide to the bony site.
  • a system of guides as described in previous clauses which are sized incrementally to cope with anatomy of different individuals, all with connectivity for spacing components so that software can select the guide body, and choose appropriate spacing components such that the guide better fits the bony surface, and that there is sufficient space available between the main body of the guide and the bony surface to permit optimal positioning, and also orientation of the guide.
  • Figure 1 is a schematic depiction of the acetabulum of a patient
  • Figure 2 is a schematic side view of an acetabulum with a patient specific drilling guide according to the prior art
  • Figure 3 is a schematic side view of the acetabulum of Figure 2 with the patient specific drilling guide removed;
  • Figure 4 shows a plurality of schematic views, from different perspectives, of a surgical guide body according to an embodiment of the invention
  • Figure 5A is a perspective view of a surgical guide according to an embodiment of the invention.
  • Figure 5B is a top view of the surgical guide of Figure 5A;
  • Figure 6A is a bottom view of the surgical guide of Figures 5A and 5B;
  • Figure 6B is a top of the surgical guide of Figures 5A - 6A;
  • Figure 7A is a side view of a surgical guide according to an embodiment of the invention
  • Figure 7B is a top view of the surgical guide of Figure 7A.
  • Hip replacement or resurfacing operations are a common treatment for arthritic hip joints.
  • Revision replacements are also relatively common (10%) in view of the large numbers of primary operations.
  • a joint prosthesis is inserted, having femoral and acetabular components.
  • the longevity of the reconstruction and joint prosthesis, and the health of the surrounding tissues may be adversely affected by inappropriate positioning of the components of the prosthesis, leading to inappropriate mechanical loading, adverse wear and tear, loss or stability and biological complications.
  • Positioning problems are more often associated with the acetabular component; equally, correcdy positioning the acetabular component appears to favour a longer lasting outcome, with ideal contact between femoral and acetabular components, and ideal load distribution and optimised wear of the two parts.
  • acetabulum Access to the acetabulum is a somewhat invasive surgical intervention, particularly if the head of the femur is preserved, as with 'resurfacing' procedures. Without wide exposure of the area, it can be difficult to adequately orientate the prosthetic components, particularly the acetabular component. However, post-operative healing and rehabilitation is improved by minimising surgical exposure of the acetabulum.
  • Such techniques require preoperative planning using eg. 3D imaging of the pelvis to plan an 'ideal' position for the acetabular component, but rely upon the availability of sophisticated apparatus.
  • Rapid prototyping / additive manufacturing / CAD CAM production, to fabricate a bone supported cutting or patient specific drilling guide (RPG) are not readily applicable to the acetabulum, because in order to seat a rapid prototyped guide over the acetabulum for preparation of the acetabulum, it is the acetabulum itself, which needs to be prepared for the prosthesis.
  • RPG patient specific drilling guide
  • Figure 1 shows the acetabulum and adjacent surfaces, including the ilium of the pelvis (1), the inferior margin of the true floor of the acetabulum; cotyloid fossa; and various parts of the acetabular rim (P) and the acetabular notch (2) .
  • Figure 2 shows how this issue may be dealt with by using the RPG (3) to transfer a guiding relationship to an additional guide (18) anchored into the Ilium, or other mechanically stable frame of reference to form a 'Guiding Assembly' (GA) .
  • the RPG can be removed from the acetabulum to allow access to the acetabulum for reaming and implantation as in figure 3.
  • the fixated GA is then, in turn, used to achieve accurate surgical preparation of the acetabulum and implant positioning to the planned position.
  • 3D imaging including but not restricted to Computed Tomography (CT), Cone Beam Computed Tomography (CBCT), optical scanning, and magnetic resonance imaging (MRI) may be used to generate a 3D dataset of the pelvis which is viewed in an on-screen virtual environment.
  • CT Computed Tomography
  • CBCT Cone Beam Computed Tomography
  • MRI magnetic resonance imaging
  • the software includes access to a library of prostheses, which may be generic in form or manufacturer specific.
  • the method provides for dedicated software having visualization, modelling, measurement, and computer aided design (CAD) functionality.
  • CAD computer aided design
  • the software enables the segmentation of the data set, with the production of an on-screen 3D model, for example by surface or volume rendering, derived from the dataset by assigning a threshold value to the data.
  • the software enables the planning of the optimal position of the Acetabula Component (AC) of a joint prosthesis in terms of axis, angulation, and depth to be planned, for example with respect to the anterior and transverse pelvic planes.
  • AC Acetabula Component
  • the surgeon (or other operator) is then able to indicate on screen the extent of the proposed surgical exposure of the acetabulum (Figure 1) and adjacent surfaces, including the ilium of the pelvis (1), the inferior margin of the true floor of the acetabulum; cotyloid fossa; and various parts of the acetabular rim (P) and the acetabular notch (2) .
  • a desired position can then be determined in the software for a PAD to hold a guiding component for a guiding assembly for the AC based on the planned position of the AC and a known relationship between the position of a PAD and the position of a guiding component coupled to the PAD.
  • a desired position for a guiding assembly can be determined based on the planned position of the AC; a desired position for a guiding component can be determined based on the desired position of the guiding assembly; and a desired position of the PAD can be determined based on the desired position of the guiding component.
  • the desired position of the PAD, guiding assembly and/or guiding component can be planned in the software by a surgeon or other operator, or can be determined automatically by the software.
  • the software can then determine a desired configuration for spacing components to seat the PAD in its desired position, using a calibrated specification for the PAD and the 3D model of the surgical exposure or bony surface. The details of this are provided below.
  • the software uses the surface data and described perimeter to create a digital specification for the PAD.
  • the PAD has a generic structure having a body (4) that fits within the acetabulum. Different sized PAD's are available, so as to be able to achieve the closest possible 'best' fit for the body of the PAD, along with spacing components (SCs) .
  • SCs spacing components
  • the software allows an appropriately sized PAD to be selected from the PAD library, such that it will fit within the defined perimeter, appropriately approximated to the acetabular surface.
  • a body of the PAD (4) may take a number of forms, ranging from a skeletal object that may or may not fit in contact with a few carefully defined points within the acetabulum and around the perimeter, or, it may be more robust and bulky.
  • the perimeter of the pad may be selected to fit within the perimeter of the acetabulum.
  • the PAD is designed to include features which can be calibrated within the associated software, and possibly also visible on-screen, to allow the guiding assembly (GA) (figures 2 and 6) to be set up in a corresponding manner to that shown and described with respect to Figure 2.
  • the goal is that the PAD is only temporarily fitted into place, but has features that permit the drill guide element of the 'remotely' anchored GA to be oriented such that it does not interfere with preparation of the acetabulum.
  • FIG. 5 there is a recess ( Figure 5, (5)) in the depth of the part of the PAD that fits into the acetabulum.
  • This recess has a standardised configuration, such that a standard Guiding Component (GC) may be precisely seated within the recess in a predetermined relative position.
  • the position of the GC can be configured to reflect the optimum vector for the mechanical preparation of the acetabulum by appropriate orientation of the PAD as described below.
  • suitable markings along the length of the GC which may correspond to markings on the instrumentation used to prepare the acetabulum, may indicate the ideal depth for the preparation.
  • the body (4) includes a first surface (13) which is arranged to face the acetabulum and a second surface (14) which is arranged to face away from the acetabulum.
  • the body (4) includes a main part (15) and a plurality of spokes (10) extending radially or laterally from the main part (15) .
  • the main part in this embodiment is bulbous; it is substantially hemispherical. However, the main part is selected to be shaped in accordance with the area of the patient in which it is going to be used. Accordingly, in other embodiments, the main part may have other shapes. If the main part can be considered to have an axis, which is substantially perpendicular to the bony surface of the patient, and m the direction m which the guiding component is to be inserted, the spokes can be considered to extend radially from that axis. The spokes extend substantially parallel to the surface surrounding the acetabulum so that spacing components coupled to the spokes can provide a desired spacing between the spokes and the bony surface of the patient, as described below.
  • spokes (10) there are three spokes (10) extending from the main part and these are spaced at equal angular intervals.
  • the first surface (13) of the body can be provided with coupling elements, for example in the form of recesses or holes (8), to receive spacing components to provide a desired spacing between the body and the acetabulum.
  • the recesses or holes (8) can be on the main part and/or on the spokes.
  • spokes in other situations and embodiments, for example the preparation for a knee prosthesis, spokes are not required as it is only the direct seating of the programmable guide that may be relevant
  • a recess or hole (9) at the base of the PAD is provided such that the bony base of the acetabulum may be visualised and explored with an instrument by removing the GC, so as to be able to verify the fit of the PAD against the bony surface, and this is an advantage of more skeletal designs, in that the contact between the SCs and the bony base and perimeter may be visualised or explored with a graduated probe.
  • Embodiments provide for a standardised system of PAD's which have a general configuration to fit a range of differendy sized acetabula - that is the body is available in a range of different sizes.
  • an appropriately sized PAD is selected from the range available, to fit within the acetabulum such that the planned central access of the future acetabular prosthesis lines up with the central axes of the guide (also known as a jig), leaving a small space between the jig and the patient acetabulum.
  • This process is facilitated within the associated software application, which enables a library of components to be tried in the virtual environment onto a segmented virtual model of the patient's acetabulum.
  • the orientation of the PAD can be determined by automated or manual selection of appropriately configured spacing components (SCs), such that when the correct components (7, 11) are fitted into the recesses or holes (8) in the guide, the PAD is orientated in an orientation pre-planned in the associated software (and so too therefore are the GC and therefore the GA orientated in a pre-planned orientation once they are coupled to the PAD) .
  • the PAD can receive a plurality of spacing components (SCs, 7, 11) extending from the body (4) .
  • the spacing components are selectively configurable in order to provide an appropriate spacing from the acetabulum to provide the desired orientation to the PAD.
  • the spacing components can take a variety of forms, provided that they can hold the body of the guide at a desired spacing from the bony surface of the patient at the point at which they are coupled to the body of the guide.
  • the spacing components are rigid and often elongate. They can for example be solid or hollow elongate members, for example tubes. In the embodiment of Figures 5 and 6, they are straight.
  • the spacing components can be all the same size, or can be different sizes.
  • a first type (7) of spacing component is provided for the coupling elements on the spokes (10) .
  • the spacing components (7) of the first type include a shoulder (17) to abut a rim (P) of the acetabulum.
  • a second type (11) of spacing component is provided for the coupling elements in the main portion of the body.
  • the spacing components (11) of the second type are studs.
  • two types of spacing component are described here, there may be more or fewer than two types, and the types are not restricted to types with shoulders, and studs.
  • the embodiment of Figures 5 and 6 has one type of spacing component on the main portion and one type on the spokes, the types do not need to be segregated in this way in all embodiments. There can be multiple types of spacing component all over the guide.
  • the recesses or holes (8) of the main portion are designed to firmly retain a range of studs (11), which may be pressed into the jig.
  • the spacing components provide the desired relationship between the PAD and the acetabulum.
  • Anti-rotational features may be provided on one or more of the spacing components.
  • Figure 6A shows such an anti-rotational feature in the form of a rod (12) coupled to an end of a spacing component (11), the rod being of a length and position defined by software to fit into the acetabular notch to prevent rotation of the guide.
  • other anti- rotational features may be provided and these may be in the form of rods or other protrusions on one or more spacing components.
  • the specification for the spacing components is derived from the associated software program which generates a specification for the PAD, and a specification for length and position of each of the spacing components. For example, a particularly sized PAD, and colour coded stud available in 0.5mm increments.
  • the software program can use the planned optimal position of the Acetabula Component to determine a desired position of the guiding component for the guiding assembly.
  • the software can thence determine a desired position of the body of the guide.
  • the software can determine the configuration of the spacing components in order to seat the body of the guide in the desired position.
  • the PAD can therefore be orientated such that the GC is correctly orientated to guide surgery such that the implant is correctly located.
  • the spacing components can be selected and/or configured and positioned in appropriate recesses or holes of the body of the guide. Appropriately sized spacing components can be selected, and/or spacing components can be trimmed to size in accordance with the determined configuration. The selection, configuration and positioning of the spacing components can be done manually or robotically.
  • the acetabular jig may be 'programmed' to fit into the acetabulum with a planned orientation.
  • the orientation of the PAD, and therefore of the associated GC may be altered in small, known, and clinically relevant increments.
  • the PAD may be positioned with a normal, exposure of the site, save perhaps for slight extension on to the ilium and beneath the transverse acetabular ligament. With the PAD in place, the seating of the PAD may be verified before the GC is inserted.
  • Embodiments of the present invention therefore enable a surgeon to plan an operation using an image of the patient in software, and to have the software determine precisely how to configure a surgical guide body in order to provide a surgical guide that precisely aligns with the individual patient's tissue surface to hold a guiding component in the correct position and orientation to allow the planned surgical operation to be carried out in an optimal fashion. Embodiments are able to do this without the delays and extra costs associated with rapid prototyped patient specific guides.
  • Spacing components may take many generic forms and configurations, may be designed to fit the particular anatomy that they will encounter, for example a 'V shape to more firmly locate onto a rim, or a point to penetrate tissue.
  • Spacing components may be mass produced and disposable or reusable, available in a range of increments, or may be made using RP technologies, using a specification / design output from the associated software. Such RP SCs may be used alone or in combination with generic SCs.
  • FIG 7 An embodiment illustrated in figure 7 is provided with spacing components in the form of radiating, graduated spokes (16) . While the spacing components in embodiments described above are non-integral and are coupled to coupling elements in the body of the guide, the spokes of figure 7 may be integral with the body of the guide.
  • the spokes (16) can be trimmed according to a specification defined by the software, with an associated trimming tool.
  • Associated with the spokes there may also be provided cylindrical sleeves of different lengths and diameters which may be pressed firmly over the spokes, to extend the PAD to the perimeter of the acetabulum, and widen the spoke, to take up the space between the spoke and the bony perimeter.
  • sleeved studs may be provided to elongate as well as widen the spokes.
  • code e.g., a software algorithm or program
  • firmware e.g., a software algorithm or program
  • computer useable medium having control logic for enabling execution on a computer system having a computer processor.
  • Such a computer system typically includes memory storage configured to provide output from execution of the code which configures a processor in accordance with the execution.
  • the code can be arranged as firmware or software, and can be organized as a set of modules such as discrete code modules, function calls, procedure calls or objects in an object-oriented programming environment. If implemented using modules, the code can comprise a single module or a plurality of modules that operate in cooperation with one another.

Abstract

L'invention concerne un guide chirurgical pour lequel un corps (4) est conçu afin d'être placé sur une surface de tissu. Le corps (4) comprend au moins un élément de couplage (8). Le ou les éléments de couplage (8) sont conçus pour recevoir sélectivement un élément d'espacement devant s'étendre à partir du corps (4), permettant ainsi d'asseoir le guide sur une surface de tissu de façon prédéterminée. L'invention concerne également le guide chirurgical et le procédé associé.
PCT/GB2014/052023 2013-05-03 2014-07-03 Guide chirurgical WO2014177894A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB1308071.8A GB2517672A (en) 2013-05-03 2013-05-03 A programmable alignment jig for orthopaedic surgery
GB1308071.8 2013-05-03

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WO2014177894A1 true WO2014177894A1 (fr) 2014-11-06

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10251723B2 (en) 2013-11-25 2019-04-09 Prometheus Surgical Limited Method and apparatus for use in the production of a surgical guide
CN113413252A (zh) * 2021-07-16 2021-09-21 浙江大学 一种可塑性通用型髋臼精准定位手术导板

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WO2012021857A2 (fr) * 2010-08-13 2012-02-16 Mason James Bettenga Guides chirurgicaux
WO2012058349A2 (fr) * 2010-10-29 2012-05-03 The Cleveland Clinic Foundation Système et méthode d'association d'un dispositif de guidage avec un tissu
WO2012058344A1 (fr) * 2010-10-29 2012-05-03 The Cleveland Clinic Foundation Système et méthode facilitant la fixation d'un implant prêt à l'emploi dans un tissu chez un patient

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ES2545398T3 (es) * 2009-06-30 2015-09-10 Blue Ortho Guía ajustable para cirugía ortopédica asistida por ordenador
GB201004878D0 (en) * 2010-03-24 2010-05-05 Dawood Andrew J S A positioning guide for hip joint replacement/resurfacing prosthesis

Patent Citations (3)

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Publication number Priority date Publication date Assignee Title
WO2012021857A2 (fr) * 2010-08-13 2012-02-16 Mason James Bettenga Guides chirurgicaux
WO2012058349A2 (fr) * 2010-10-29 2012-05-03 The Cleveland Clinic Foundation Système et méthode d'association d'un dispositif de guidage avec un tissu
WO2012058344A1 (fr) * 2010-10-29 2012-05-03 The Cleveland Clinic Foundation Système et méthode facilitant la fixation d'un implant prêt à l'emploi dans un tissu chez un patient

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10251723B2 (en) 2013-11-25 2019-04-09 Prometheus Surgical Limited Method and apparatus for use in the production of a surgical guide
US10835343B2 (en) 2013-11-25 2020-11-17 Prometheus Surgical Limited Method and apparatus for use in the production of a surgical guide
CN113413252A (zh) * 2021-07-16 2021-09-21 浙江大学 一种可塑性通用型髋臼精准定位手术导板
CN113413252B (zh) * 2021-07-16 2022-06-17 浙江大学 一种可塑性通用型髋臼精准定位手术导板

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GB2517672A (en) 2015-03-04
GB201308071D0 (en) 2013-06-12

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