• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    Current application concerns surgical guiding instruments used to guide surgical elements during bone surgery. A surgical guide instrument may include a body including clip (s) configured to attach the surgical guide instrument to portions of the bone, a first clip comprising a snap-fit portion including a flexible structure for increasing a clamping force of the first clip and allows easy removal of surgical guide instruments from the bone. The surgical guiding instrument includes at least one aperture for guiding a surgical instrument. Current application envisions methods for manufacturing surgical guide instruments and using instruments for placement on a bone.
    公开号:BE1021358B1
    申请号:E2013/0556
    申请日:2013-08-27
    公开日:2015-11-05
    发明作者:Louis Keppler；Nele Daeman；Katreina Nikonenko
    申请人:Materialise Nv；
    IPC主号:
    专利说明:

    Surgical guiding instruments and systems and methods for manufacturing surgical guiding instruments
    Technical field
    The present invention relates to surgical guiding instruments for use in guiding a surgical instrument during orthopedic surgery. This application also relates to methods for manufacturing surgical guiding instruments and methods for using surgical guiding instruments in bone surgery.
    State of the art
    Surgical guidance instruments help surgeons and have wide applications in orthopedic surgery. Surgical guidance instruments allow a surgeon to accurately transfer a pre-operative surgical plan to the operating room. Furthermore, surgical guiding instruments can assist in guiding surgical instruments, such as a cutting or sawing instrument, along a predefined cutting or sawing path.
    Problems can arise when adaptable surgical guiding instruments, which may include components that can be positioned to attach to or around a portion of a bone, are unstable or transmit inaccurate surgical instrument lead positions. For example, a surgical guiding device may not fit on the patient's bone and may be unstable as a result. Furthermore, the leading position for a surgical instrument may be inaccurate due to the amount of distance between the supported anatomy and the planned inlet of the surgical instrument. Furthermore, surgical guiding instruments can be large or bulky, and may require the availability of a large surgical window.
    In view of these and other shortcomings recognized by the inventors, there is a need for surgical guidance instruments that provide a safe and stable attachment to a patient's bone and that provide the ability to accurately and efficiently guide a surgical instrument in or on a bone from a patient.
    Description of the invention
    Various implementations of systems, methods, and devices within the scope of the appended claims each have different aspects, none of which is responsible for all desirable features described herein. Without limiting the scope of the appended claims, some notable features are described herein.
    The current application generally relates to surgical instruments that may be patient-specific. Details of one or more embodiments of the subject described in this specification are set forth in the accompanying drawings and the description below. Other features, aspects and advantages will become apparent from the description, the drawings, and the claims. One aspect of the subject described in the disclosure provides a surgical guiding instrument for a bone. The surgical guiding instrument comprises a body comprising one or more clamps formed to attach the surgically guiding instrument to one or more parts of the bone, a first clamp of the one or more clamps including a snap-fit part comprising a flexible structure for increasing a clamping force of the first clamp and allowing easy removal of the surgical guiding instrument from the bone. The body further includes at least one opening for guiding a surgical instrument.
    Another aspect of the subject described in the disclosure provides a method for manufacturing a surgical guiding instrument. The method includes designing the surgical guiding instrument to create a surgical guiding instrument design, the surgical instrument design including a body comprising one or more clips formed to attach the surgical guiding instrument to one or more parts of a bone, a first clamp of the one or more clamps contains a snap-fit part, comprising a flexible structure for increasing a clamping force of the first clamp and allowing easy removal of the surgical guiding instrument from the bone. The body further includes at least one opening for guiding a surgical instrument. The method further comprises manufacturing the surgical guiding instrument based on the surgical guiding instrument design.
    Yet another aspect of the subject described in the disclosure provides a femoral surgical guiding instrument for the distal end of a femur. The femoral surgical guiding instrument comprises a body comprising a front portion formed to attach the surgical guiding instrument to one or more osteophytes on a front portion of the femur. The body further comprises one or more clamps formed to attach the surgical guiding instrument to one or more thigh bone joint nodules and at least one opening for guiding a surgical instrument.
    Brief description of the drawings
    The following description of the figures is only exemplary in nature and is not intended to limit the current teachings, their applications or use. Throughout the drawings, corresponding numerals refer to identical or corresponding parts and functions. Please note that the relative dimensions of the following figures cannot be drawn to scale. FIG. 1a shows an example of a front view of a femur. FIG. 1b illustrates examples of alternative views of a femur. FIG. 2a and 2b illustrate an example of a surgical guiding instrument formed for attachment to the bone. FIG. 3 illustrates another example of a surgical guiding instrument formed for attachment to the bone and comprising a flexible structure. FIG. 4 illustrates yet another example of a surgical guiding instrument formed for attachment to the bone and including a flexible structure. FIG. 5 illustrates an example of a flexible structure for use with a surgical guiding instrument. FIG. 6 illustrates another example of a flexible structure for use with a surgical guiding instrument. FIG. 7a and 7b illustrate an example of a clamping structure that can serve as a retractor. FIG. 8a and 8b illustrate an example of a surgical guiding instrument formed to attach to a backbone. FIG. 9 illustrates an aspect of a method of manufacturing a surgical guiding instrument.
    Embodiments of the invention
    The following detailed description relates to certain specific embodiments. However, the teachings herein can be applied in a variety of ways. Reference is made in this description to drawings in which identical parts are designated by the same reference numerals.
    The current application will be described with reference to specific embodiments, but the invention is not limited thereto but only by the claims.
    As used herein, the singular forms "a," "the," and "the" contain both singular and plural unless the context clearly dictates otherwise.
    The terms "includes", "comprising", "contains" and "containing" as used herein are synonymous with "inclusive" or "including" and are open and do not exclude additional unnamed members, elements or process steps. The terms "comprises", "comprising", "contains" and "containing" when referring to said components, elements or process steps also include embodiments that "consist of" said components, elements or process steps.
    Furthermore, the terms first, second, third and the like in the description and in the claims are used for the distinction between similar elements and not necessarily for describing a consecutive or chronological order, unless otherwise indicated. It should be understood that these terms are so used, are interchangeable under appropriate conditions, and that the embodiments of the invention described herein are capable of operating in sequences other than those described or illustrated herein.
    References in this description to "one embodiment" or "an embodiment" mean that a particular feature, structure, or feature described with respect to the embodiment is included in at least one embodiment of the current application. Thus, appearances of the phrase "in one embodiment" or "in an embodiment" at different places throughout this disclosure do not necessarily all refer to the same embodiment, but this is possible. In addition, the specific features, structures or characteristics may be combined in any suitable manner, as becomes apparent to one skilled in the art from this disclosure in one or more embodiments. In addition, while some embodiments described herein include some but not all of the features that are present in other embodiments, combinations of features of different embodiments are intended to fall within the scope of the application, and constitute different embodiments, as would be understood by the craftsman. For example, in the appended claims, one of the features of the claimed embodiments can be used in any combination.
    The term "about" as used herein when referring to a measurable value such as a parameter, an amount, a duration, and the like, is intended to include variations of +/- 10% or less, preferably +/- 5% or less, more preferably + 1 / -1% or less, and even more preferably + 1 / -0.1% or less of the declared value, insofar as such variations are suitable for carrying out in the described invention. It should be clear that the value to which the provision "roughly" refers itself is also specifically, and preferably, described.
    Reciting numeric ranges via end points includes all numbers and fractions included in the respective ranges, as well as the said end points.
    The current application reveals surgical guidance instruments that may be patient-specific. The surgical guide instruments provide an accurate and stable attachment to the bone, which allows a stable and accurate inlet of a surgical instrument into the bone. This application further describes medical image-based surgical guidance instruments that may be patient-specific. These patient-specific instruments can provide the ability to accurately insert a surgical instrument into the patient's bone according to a predefined schedule.
    The term "patient-specific" as used herein refers to surgical devices, tools, and / or guidance instruments as described herein, which are designed starting with an individual anatomy of a patient to provide patient-specific devices, tools, or guidance instruments with a perfect fit or functioning in a unique, tailor-made way for a specific individual patient. The use of patient-specific devices, tools, or guidance instruments provides improved or optimized surgical interventions, orthopedic structures, and / or kinematics for the patient. Similar benefits are obtained when such patient-specific devices are used in combination with standard implants, instruments, devices, surgical procedures, and / or other methods.
    In some embodiments, during preoperative procedures, a surgeon or physician may identify different areas of a specific patient's bone, as described below with respect to the femur 100, and, based on the identified areas of the bone, may have an optimal design for various surgical procedures. determine leading instrument components (e.g., a clamp, body, opening, etc., of a surgical guiding instrument). A surgeon or physician may further determine optimal locations for attaching a surgical guiding instrument based on the identified areas of the bone. Preoperative procedures often involve obtaining an image of a patient's bone prior to performing the surgery. Digital patient-specific image information can be provided by any suitable means known in the art, such as, for example, a computer tomography (CT) scanner, a magnetic resonance imaging (MRI) scanner, an x-ray. or an ultrasound scanner.
    An advantage of the surgical guiding instruments described in the present application provides that sufficient information can be obtained to design a guiding instrument for safe and stable placement on a patient's bone based on either CT or MRI images. Bone cartilage areas may not be visible on the images of CT scans, and as a result, these cartilage areas cannot be used to fit a surgical guiding device to the patient. A physician may not be able to locate an optimal position or area on the bone for attachment of the surgical guiding instrument due to the restricted areas of the bone that are visible to the physician. Thus, available attachment areas on the bones for the guiding instruments may be limited. Consequently, surgical guidance instruments capable of providing a safe and stable attachment to the bone, together with methods for identifying optimal locations on the bone, are desirable even with limited attachment areas.
    Preoperative planning may include the construction of a three-dimensional (3D) virtual model of a bone, or a part thereof. In some embodiments, the construction of the virtual 3D model can begin with scanning the patient. For example, scanning may include a scanning technique that generates medical volumetric data, such as a CT scan, an MRI scan, or the like. In some embodiments, the outcome of the scan may include a stack of two-dimensional (2D) segments that forms a 3D data set. The result of the scan can be digitally entered into a computer program and can be converted using algorithms known in the field of image processing technology to produce a 3D computer model of the bone. For example, the virtual 3D model can be built from the data set using a computer program such as Mimics ™ supplied by Matérialisé NV, Leuven, Belgium. Once the 3D volume of the bone, or part of it, has been reconstructed, the surgeon can determine the desired position, orientation, depth and diameter of the bores and drill paths required for the operation. Based on the particular surgical needs, the surgeon or a physician can design, manufacture and / or manipulate a surgical guiding instrument to meet the needs of the specific patient. FIG. 1a shows one example of a front view of a femur 100. Although the description herein describes a femur, a person skilled in the art will understand that the content of the present application also applies to other bones, such as the humerus, shoulder blade, tibia, fibula, leg and other shoulder, hip, ankle, and / or finger bones. The front area shown in FIG. 1a is located at the distal end of the femur 100. The front portion of the femur 100 can provide a portion 102 that can be used to attach and secure a surgical guiding instrument thereto. For example, osteophytes may be located on the anterior region of the femur 100, and may be used to attach a surgical guiding instrument to the femur 100. An osteophyte is a bony protrusion that forms along bones, such as a joint, and may occur in patients with arthritis. For example, one or more osteophytes protruding from the surface of a femur may provide a surface to which a surgical guiding instrument may be connected (e.g., in whole or in part). A medial joint knob 108 and a lateral joint knob 110 are also located at the distal end of the femur 100. Holes 104 and 106 may be aligned with one or more openings of a surgical guiding instrument and may be made with a surgical instrument (e.g., a surgical instrument) drill) inserted into the one or more openings. Details regarding various embodiments of surgical guiding instruments will be discussed below. FIG. 1b illustrates examples of alternative views of the femur 100 illustrated in FIG. 1a. FIG. 1b in particular illustrates the medial articulated lump 108 and lateral articulated lump 110 located at the distal end of the femur 100. The medial 108 and lateral articulated joints may also provide one or more parts that can be used to attach and attach a surgical guiding instrument. to ensure. For example, a lateral region 112 and a medial region 114 of the medial knotter 108 may be used to attach and secure a surgical guiding instrument. In some embodiments, lateral and medial regions of the lateral joint node 110 can be used to attach and secure the surgical guiding instrument. For example, lateral and medial regions of the lateral articulation 110 can be used in addition to the lateral region 112 and medial region 114 of the medial articulation 108 to attach a surgical guiding instrument to the femur 100. As another example, only the lateral and medial regions of the lateral joint node 110 are used as an alternative to the lateral region 112 and the medial region 114 of the medial joint node 108. In some embodiments, osteophytes on the medial joint node 108 and / or the lateral joint node 110 can be used to guide a surgical guiding instrument to confirm and insure.
    As indicated above, in some embodiments, the patient-specific regions of a bone may contain specific anatomical features that can be used to attach a surgical guiding instrument. Detailed geometric and patient-specific information is used in the design and manufacture of a surgical guiding instrument to determine those surfaces of the bone that are suitable for this purpose. For example, as described above, one or more osteophytes protruding from the surface of a bone, such as a femur, may provide a surface to which a surgical guiding instrument may be attached. In addition to the osteophytes, a medial joint knob 108 and / or a lateral joint knob 110 can define one or more parts that can be used to attach and secure a surgical guiding instrument thereon. In some embodiments, the medial joint knob 108 and / or the lateral joint knob 110 can be used to attach a surgical guiding instrument to the bone independently of the one or more osteophytes.
    A method of manufacturing a surgical guiding instrument may include designing the surgical guiding instrument to create a surgical guiding instrument design, which may include identifying and selecting at least one portion of a bone that has specific features that attach to a surgical guiding instrument can allow. For example, a surgical guide instrument for a bone can be designed and manufactured, and can include a body that includes one or more clamps. The terminals can take different forms and perform different functions. In some embodiments, the clamps are formed to attach the surgical guiding instrument to one or more parts of the bone, a first clamp of the one or more clamps including a snap-fit portion with flexible structure for increasing a clamping force of the first clamping and allowing easy removal of the surgical guiding instrument from the bone. The flexible structure can include any structure that can be used to increase the clamping force of the first clamp and to facilitate the removal of the surgical guiding instrument from the bone. For example, as discussed below, the flexible structure may comprise a snap-fit portion with a material with a thickness that is less than the average thickness of the rest of the body. As another example, the flexible structure may comprise one or more fastening mechanisms, such as a group of bands or chains or a honeycomb structure, connecting a first portion (e.g., a medial portion) of the first clamp to a second portion (e.g., laterally) of the first clamp. Further examples of a flexible structure may include fastening mechanisms using one or more screws to lock an undercut portion, with the help of a retractor, with a spring-loaded lock, by means of a spring in combination with a hinge, with a push-button lock, etc. The flexible structure may further comprise a reference mechanism that can be used to confirm that the surgical guiding instrument is correctly attached to the bone. The surgical guiding instrument (e.g., the body) may further comprise at least one opening for further guiding a surgical instrument. In another example, a femoral surgical guiding instrument for a distal end of a femur may be designed and manufactured, and may include a body including a front portion formed to attach the surgical guiding instrument to one or more osteophytes on a front portion of the femur femur, and one or more clamps formed to attach the surgical guiding instrument to one or more femoral joints of the femur. In this example, the femoral surgical guiding instrument (e.g., the body) may further comprise at least one opening for guiding a surgical instrument.
    Manufacturing and / or designing a surgical guiding instrument may further include determining the correct position of the leading component of the surgical guiding instrument (e.g., an opening) with respect to the bone. In specific embodiments, this can be done based on the preoperative planning of the desired job of the surgical instrument in the bone. The orientation of the guiding component can be such that the surgical instrument is guided in the predetermined direction. Preoperative planning by a physician makes it possible to determine the required trajectory of the surgical instrument, and therefore the required direction of the leading component. The preoperative planning can be performed using appropriate special software based on appropriate medical images (of which CT, MRI are examples), taking into account factors such as bone quality and the proximity of nerve bundles / blood vessels or other anatomically sensitive objects. In some embodiments, preoperative images are imported into a computer workstation with 3D software for the purpose of planning and simulating the operation. The input images can be manipulated as 3D volumes and a computer simulation can be created that executes a schedule containing the data necessary to adjust the orientation of the leading component.
    The manufacture of a surgical guiding instrument may further comprise the manufacturing of the surgical guiding instrument based on the design. FIG. 7 gives an example of a method for manufacturing a surgical guiding instrument, and is described in more detail below. FIG. 2a and 2b illustrate an example of a surgical guiding instrument 200 formed for attachment to a bone. In some embodiments, the surgical guiding instrument 200 may be a femoral surgical guiding instrument for a distal end of a femur 212. While the disclosure herein may describe a femur 212 as an example of the bone, one of ordinary skill in the art will appreciate that the contents of the present application include other bones such as the humerus, shoulder blade, tibia, fibula, bones, vertebral column, and others. shoulder, hip, ankle and / or finger bones. The surgical guiding instrument 200 includes a body 202 configured to adhere to at least one region or portion of the femur 212. The body 202 includes a first portion 214, such as a front portion, that is configured to attach the surgical guiding instrument to a anterior region of the femur 212. For example, the first portion 214 can be configured to attach the surgical guiding instrument 200 to one or more osteophytes on the anterior region of a femur 212. In some embodiments, the first portion 214 can be configured to attach the surgical guiding instrument to one or more osteophytes anywhere along a bone, such as one or more osteophytes on the distal end of the humerus. The first portion 214 attaches and secures the surgical guiding instrument 200 to the femur 212. The first part 214 can be configured, for example, to rest on one or more osteophytes and thus limit unwanted movement of the surgical guiding instrument 200. In this example, as described below, a clamp 204 can be used to secure the surgical instrument 200 on the femur 212. In some embodiments, the first portion 214 may include a flexible snap-fit portion for increasing a clamping force of the first portion 214 on the upper leg 212 and allowing easy removal of the surgical guiding instrument 200 from the bone 212. For example, the first part 214 can be made of a flexible material that creates a clamping force to pinch a portion of a femur 212 (e.g., a osteophyte), and at the same time allow a physician to easily remove the surgical guiding instrument 200 from the femur 212.
    The body 202 of the surgical guiding instrument 200 further comprises a clamp 204 configured to attach the surgical guiding instrument 200 to one or more parts of the femur 212. For example, the clamp 204 may be configured to attach the surgical guiding instrument 200 to a joint bump of the femur 212, such as the medial joint bump as illustrated in Figures 2a and 2b. The fixed attachment of the clamp 204 to a joint bump ensures that the surgical guiding instrument 200 remains in a stable and fixed position during a surgical procedure. The amount of displacement of the clamp 204 needed to place the surgical guiding instrument on the femur 212 depends on the thickness of the part of the femur 212 (e.g., a joint node) to which the clamp is to be attached and the degree of or the angle at which the clip 204 spans the contour of the part of the femur 212 upon placement of the surgical guiding instrument thereon. In some embodiments, an overhang of the ends (referred to as a "undercut" part) of the clamp 204 is created when the surgical guiding instrument 200 is placed on the femur 212. The undercut part of the clamp 204 may be, for example, a clamping or snap mechanism. which encloses the joint bump and creates a stable and fixed attachment of the surgical guiding instrument 200 to the femur 212. In some embodiments, the clamp 204 may include a snap-fit portion including a flexible structure for increasing a clamping force of the clamp 204 and allow easy removal of the surgical guiding instrument 200 from the femur 212. For example, a snap-fit portion of the clamp 204 including the flexible structure can be configured to allow stable and fixed attachment of the surgical guiding instrument 200 to a joint bump of the femur 212 by increasing the clamping claw of the clamp 204, and while allowing a physician to easily remove the surgical guiding instrument 200 from the femur 212. Details regarding different embodiments of a snap-fit portion of a clip are described below. In some embodiments, the surgical guiding instrument 200 may include more than one clip, similar to terminal 204. The body 202 may include, for example, a second clamp that can be configured to attach to the lateral articulation of the femur 212 in addition to the clamp 204. The use of a second clamp may contribute to further stability of the surgical guiding instrument 200 on the femur. 212.
    The use of the first part 214 together with one or more clamps, such as clamp 204, ensures that the surgical guiding instrument remains fixed on the femur 212, or other bone, even with limited attachment areas on the bones for attaching the guiding instrument (e.g. due to cartilage areas that are not visible on the images of CT scans, as described above). By attaching the surgical guiding instrument 200 in a stable manner with the aid of the first part 214 and the one or more clamps, the surgical guiding instrument can be fixedly and accurately placed on the bone so that a surgical intervention can be performed more accurately and safely as a result of little or no movement of the guide. By attaching the first portion 214 to the anterior region of the femur 212 (e.g., to an osteophyte), and further attaching one or more clamps, such as clamp 204, to one or more joint nodules, the surgical guiding instrument 200 will be limited are in different displacement and rotational movements and (e.g. posterior and anterior sliding, distal and proximal sliding, media material sliding, internal-external rotation, varus-valgus movements, and / or flexion extension).
    The surgical guiding instrument 200 further includes apertures 206, 208, and 210, which can be aligned with areas of the femur 212 corresponding to locations to be approached during surgery, such as locations where holes are to be drilled. Holes 104 and 106, illustrated in Figure 1, may be aligned with the apertures 206 and may be created using a surgical instrument device inserted into the apertures 206, such as a drill, dentist drill, saw, jigsaw, lateral drill or any other cutting , milling or drilling tool. The apertures 206, 208, and 210 are positioned so that a surgical instrument device passed through one or more of the apertures 206, 208, and 210 can reach the bone at the desired location. The apertures 206, 208, and 210 can be positioned in any direction relative to the bone as long as it provides access to a surgical instrument device to reach the bone at the desired location. In some embodiments, the apertures 206, 208, and 210 may protrude from the surface of the body 214, as illustrated in Figures 2a and 2b. In some embodiments, the apertures may include safety stops to prevent a surgical instrument device from continuing beyond a planned or predetermined depth in the bone. While the description herein may describe apertures 206, 208, and 210 located at specific locations, one skilled in the art will understand that the content of the present application applies equally to aperture locations with respect to patient-specific locations on different types of bones, and can be determined using of preoperative procedures described above. Furthermore, the orientation and position of the apertures may correspond to preoperative planning and procedures.
    In some embodiments, the surgical guiding instrument 200 may be a single, continuous structure (e.g., a single mold) that includes all of the guiding instrument components, including the body 214, the apertures 206, 208, and 210, and the clamp 204. In some embodiments, each part of the surgical guiding instrument 200 is a separate structure that is integrated with the other components to create the surgical guiding instrument 200.
    Figure 3 illustrates another example of a surgical guiding instrument 300 configured to attach to bone and including a flexible structure 316. In some embodiments, the surgical guiding instrument 300 may be a femur surgical guiding instrument for a distal end of a femur 312. While the description herein describe a femur 312 as an example of the bone, those skilled in the art will understand that the content of the present application applies equally to other bones, such as the humerus, shoulder blade, tibia, fibula, ankle bone, and other shoulder, hip, ankle - and / or finger bones. Similar to the surgical guiding instrument 200 illustrated in Figure 2, surgical guiding instrument 300 includes a body 302, a clamp 304, apertures 306, 308, and 310, and a first part 314 (e.g., an anterior part). The body 302 is configured to attach to at least one region or portion of the femur 312 and includes a first portion 314, such as an anterior portion, which is configured to guide the surgical guiding instrument to an anterior region of the femur 312. The first portion of 314 may be configured, for example, to attach the surgical guiding instrument 300 to one or more osteophytes on the anterior region of a femur 312. In some embodiments, the first portion 314 may be configured to attach the surgical guiding instrument to one or more osteophytes anywhere along which a bone, such as one or more osteophytes, is located on the distal end of a humerus. In some embodiments, the first portion 314 may be configured to rest on one or more portions of the femur 312 (e.g., one or more osteophytes) and thus limit unwanted movement of the surgical guiding instrument 300. In these embodiments, the clamp 304 may be used to attach the surgical guiding instrument 300 to the femur 312. In some embodiments, the first portion 314 may include a flexible snap-fit portion for increasing a clamping force of the first portion 314 on the femur 312 and easy removal of the surgical guiding instrument 300 from the femur 312. For example, the first portion 314 may be made of a flexible material that creates a clamping force for pinching a portion of a femur 312 (e.g., an osteophyte), and at the same time allow a physician to easily remove the surgical guiding instrument 300 from the femur 312 .
    The clamp 304 is configured to attach the surgical guiding instrument 300 to one or more parts of the femur 312, such as a medial articular nib as illustrated in Figure 3. The clamp 304 may include a snap-fit portion including flexible structure 316 for enlarging allow a clamping force of the clamp 304 and a simple removal of the surgical guiding instrument 300 from the femur 313. The snap-fit portion may be configured to allow stable and fixed attachment of the surgical guiding instrument 300 to a thigh bone joint 312 by increasing the clamping force of the clamp 304, and while allowing a physician to easily remove the surgical to allow guiding instrument 300 of the femur 312. The flexible structure 316 of the snap-fit portion may comprise a material with a thickness that is less than the average thickness of the rest of the body 302. By manufacturing the flexible structure 316 of the snap-fit portion so that it is thinner than the rest of the body, the desired flexibility of the clamp 304 of the guiding instrument 300 can be obtained because the thinner part introduces a weakened area in the clamp 304, which allows bending of the snap-fit part of the clamp 304. For example, the flexible structure 406 provides flexibility so that a physician is able to easily manipulate the clamp 304 to fit it around a joint bump of the femur 312, and at the same time provide a clamping force sufficient to securely attach the surgical guiding instrument 300 to the femur 312 in a stable and fixed manner. In some embodiments, the flexible structure 316 may have a thickness that is between 1/2 and 1/5 of the average thickness of the rest of the body 302. In some embodiments, the minimum thickness of the flexible structure is approximately 2 mm to maintain stability of the structure. In some embodiments, the body 302 of the surgical guiding instrument 300 may include more than one clamp similar to clamp 304. For example, body 302 may include a second clamp that may be configured to attach to the lateral articulation of the femur 312 in addition to the clamp 304. The use of a second clamp may add further stability of the surgical guiding instrument 300 to the femur 212. In some embodiments, the body 302 may include a first clamp, such as clamp 304, which includes a snap-fit portion including a flexible structure , such as flexible structure 316, and a second, non-flexible clamp (e.g., with an undercut portion). In some embodiments, the body 302 may comprise two or more clips that include a snap-fit portion including a flexible structure.
    Apertures 306, 308, and 310 are similar to the apertures illustrated in Figure 2, and can be aligned with areas of the femur 312 that correspond to locations to be approached during surgery, such as locations where holes are to be drilled. For example, drill holes 104 and 106, illustrated in Figure 1, can be aligned with the apertures 306 and can be created using a surgical instrument device inserted into the apertures 206, such as a drill, dental drill, saw, jigsaw, lateral drill or any other cutting , milling or drilling tool. In some embodiments, the apertures 306, 308, and 310 may protrude from the surface of the body 314, as illustrated in Figure 3. While the description herein may describe apertures 306, 308, and 310 located at specific locations, one skilled in the art will appreciate that the The content of the current application is equally valid for aperture locations with regard to patient-specific locations on different types of bones, and can be determined using preoperative procedures described above.
    Figure 4 illustrates yet another example of a surgical guiding instrument 400 configured to attach to a bone, such as the femur 412, and including a flexible structure 406. The surgical guiding instrument 400 includes a first clamp 402 and a second clamp 410. The first clamp 402 may include a snap-fit portion including a flexible structure 406 for increasing a clamping force of the first clamp 402 and allowing easy removal of the surgical guiding instrument 400 from the femur 412. The snap-fit portion can be configured to allow stable and fixed attachment of the surgical guiding instrument 400 to a joint bump of the femur 412 by increasing the clamping force of the first clamp 402, and while allowing a physician to easily remove it surgical guiding instrument 400 of the femur 412. The flexible structure 406 includes one or more fastening mechanisms, such as a group of bands or chains, connecting a medial portion of the first clamp 402 to a lateral portion 404 of the first clamp 402. Figure 5 illustrates an example of the flexible structure 406. The one or more fastening mechanisms of the flexible structure 406 provide the desired flexibility of the first clamp 402 of the surgical guiding instrument 400 and permit the bending of the snap-fit portion of the clamp 402. The one or more fixation mechanisms may be a group of bands or chains made of a flexible material (e.g., silicone, rubber, etc.) that provides a flexible fixation of the clamp 402 to the femur 412. The one or more fixation mechanisms of the flexible structure 406 provides flexibility so that a physician can easily manipulate the clip to fit around the thigh bone joint 1212, and at the same time provide a sufficient clamping force to securely attach the surgical guide instrument 400 to the thigh bone 412 in a stable and fixed manner. Each fastening mechanism of the flexible structure 406 may further comprise one or more cylinders 408 (e.g., one cylinder for each fastening mechanism) that add rigidity and stability to the flexible structure so that the clamp fits tightly to the bone. The one or more cylinders 408 may further increase the clamping force for securely attaching the surgical guiding instrument 400 to the femur 412.
    Figure 6 illustrates another example of a flexible structure 600 for use with a surgical guiding instrument, such as the surgical guiding instruments described above. The flexible structure 600 includes a plurality of holes, and may be shaped as a honeycomb structure. The flexible structure 600 can be used instead of the one or more fastening mechanisms described above with respect to Figure 5. The flexible structure 600 can connect, for example, a medial part of the first clamp 402 to a lateral part of the first clamp 402. The plurality of holes adds flexibility so that a physician can easily manipulate a clamp using the flexible structure 600 to attach to a portion of a bone (e.g., a joint lump or an accessory). The plurality of holes further adds a stiffness to provide a clamping force sufficient to securely attach the surgical guiding instrument 600 to the bone. The flexible structure 600 can be used to snugly fit a clamp of a surgical guiding instrument around the joint bump of a femur to provide stable and secure fitting of the surgical guiding instrument to the femur.
    Those skilled in the art will understand that any flexible material can be used as the material for the fastening mechanism. In some embodiments, only materials that are biocompatible (e.g., USP class VI compatible) can be used as the fastener of the flexible structure 406.
    In some embodiments, the second clamp 410 of the surgical guiding instrument 400 may include an undercut portion when the surgical guiding instrument 400 is placed on the femur 412. For example, an undercut portion of the second clamp 410 may form a clamping or snap mechanism that encloses a joint bump, such as the lateral joint bump illustrated in Figure 4, and creates a stable and fixed attachment of the surgical guiding instrument 400 to the femur 412.
    In some embodiments, the second clamp 410 may include a snap-fit portion including a flexible structure for increasing a clamping force of the clamp 410 and allowing easy removal of the surgical guiding instrument 400 from the femur 412. The flexible structure of the snap-fit portion may comprise material with a thickness that is less than the average thickness of the rest of the body of the surgical guiding instrument 400, or may include one or more fastening mechanisms similar to the flexible structure 406 of the first terminal 402.
    In some embodiments, the surgical guiding instruments 200, 300, and / or 400 may be a single, continuous structure (e.g., a single mold) that includes all of the guiding instrument components, including the body, the apertures, and the one or more clamps. In some embodiments, each part of the surgical guiding instruments 200, 300, and / or 400 may be a separate structure that is integrated with the other components to create the surgical guiding instruments.
    Figure 7a illustrates a clamping structure 700 that can act as a retractor. The clamp structure 700 includes a body 702 and a clamp 704. The clamp 704 comprises an engagement surface 706 that can anatomically correspond to a portion of a patient's bone, such as a knee, shoulder, ankle, etc. In some embodiments, the clamp structure includes 700 a coupling feature 708 that permits a removable coupling of the body 702 and the clamp 708 to each other. The coupling feature 708 can, for example, form a dovetail coupling. The body 702 further comprises a clamping member 710 (e.g., a rotary clamp).
    Figure 7b illustrates an embodiment of the clamp structure 700 used with a surgical guiding instrument 712 (e.g., a patient-specific surgical guiding instrument). For example, the surgical guiding instrument 712 may be used for positioning on a shoulder bone 714. While the description herein may describe a shoulder bone 714 as an example of the bone, one skilled in the art will understand that the content of the current application is equally valid for other bones such as the femur, humerus, shoulder blade, tibia, fibula, ankle bone and other shoulder, hip, ankle, and / or finger bones. The surgical guiding instrument can be used to guide the drilling of a hole in the bone 714 via a drill guide 716. The clamping structure 700 can begin in a position suitable for inserting or removing the clamping structure in the patient. The clamping part 710 fits on a corresponding part of the surgical guiding instrument 712. The clamping structure clamp 704 comprises a retractor surface corresponding to the anatomy of the shoulder bone over which it will exert a force when the retractor surface is in its engagement position. In Figure 7b, the clamping structure 700 is illustrated in an engagement position. In this position, the retractor surface of the clamp structure engages the surgical guiding instrument 712 and pulls the guide to the bone surface, thereby creating a clamp and thus producing a stable closing fit. The clamping structure 700 further acts to retract the patient's skin while providing the clamping force on the bone.
    In some embodiments, the clamping structure 700 can be integrated with a surgical guiding instrument, such as surgical guiding instruments 200, 300, 400, and / or 716, so that the surgical guiding instrument comprises a single structure including the clamping structure 700. Integration of the clamping structure 700 with the surgical guiding instrument allows a rattling clamping structure to provide a fixed and stable placement of the surgical guiding instrument on a bone. In some embodiments, a surgical guiding instrument may include two clamping structures 700 on two opposite sides of the surgical guiding instrument. The provision of two clamping structures 700 allows a rattling force on two sides of the surgical guiding instrument, thereby providing an even more stable and firm clamping force.
    In some embodiments, the clamping structure 700 used as a retractor may include any structure for securing clamping structure 700 in place so that a physician can operate without holding the retractor in place. The clamping structure 700 may, for example, comprise a ratchet retractor that can be used to secure the clamping structure in place. The ratchet retractor can have multiple securing positions that allow a variable opening in the patient's surgical location.
    In some embodiments, the retractor may be provided with holes or other features that allow placement of pins in the bone 714, thereby securing the surgical guiding instrument and retractor in place. In some embodiments, the surgical guiding instrument 712 may further include a coupling feature that allows integration of a surgical instrument into the surgical guiding instrument. The coupling feature may have a shape corresponding to the shape of (a part of) the surgical instrument.
    Figures 8a and 8b illustrate an example of a surgical guiding instrument 800 configured to attach to a spinal column 810. The surgical guiding instrument 800 includes a first transverse protrusion clamp 802, a second transverse protrusion clamp 804, a spinal protrusion clamp, and a guiding element 808. The first and the second transverse protrusion clamps 802 and 804 include clamps capable of providing a stable and fixed attachment to the transverse protrusions of the spinal column 810. The spinal protrusion clamp 806 further provides a fixed attachment to the spinal protrusion of the spinal column 810. Each of the clamps described above with respect to Figs. 2-7, the first and second transverse protrusion clips 802 and 804 and / or the vertebral protrusion clip 806 can be used. For example, an overhang of the ends (ie an undercut portion) of the clips 802, 804, and / or 806 can be created be when it is surgical gel guiding instrument 800 is placed on the spinal column 810. The undercut portion may form a clamping or snap mechanism that encloses the transverse protrusion and creates a stable and fixed attachment of the surgical guiding instrument 800 to the spinal column 810. As another example, the clips 802, 804 may , and 806 include a snap-fit portion including a flexible structure for increasing a clamping force of the clamps 802, 804, and 806 and allowing easy removal of the surgical guiding instrument 800 from the spine 810. In some embodiments, the flexible snap-fit portion including the flexible structure may comprise material with a thickness that is less than the average thickness of the rest of the guide 800 as described above. In some embodiments, the flexible snap-fit portion including the flexible structure may comprise one or more fastening mechanisms, as described above, which may comprise a group of bands, chains or a honeycomb structure made of a flexible material. The surgical guiding instrument may further comprise a guiding element 808. The guide element 808 can include an aperture through which a surgical instrument can be placed. The guide element 808 may further comprise a drill, pin, or any other instrument used in a spinal surgical procedure. For example, a drill pin can be used to secure the guide 800 in place on the spinal column 810. In some embodiments, any number of clamps can be used to attach the surgical guiding instrument 800 to the spinal column 810. For example, a clamp can be further used to attach the surgical guiding instrument 800 to the vertebral arch, the superior joint protrusion, the arch foot, etc.
    In some embodiments, the surgical guiding instruments 200, 300, 400, 716, and / or 800 illustrated in Figures 2-4, 7, and 8 may comprise one or more handle structures (not shown) protruding from the outer surface of the surgical guiding instrument. The one or more handle structures can be used to allow simple manipulation of the guide instruments, such as for handling the guide instruments. The one or more handles can be used, for example, for placing the guide instruments over the bone or removing it from the bone. In some embodiments, the handle structures may act to open a clip, such as clip 204, 304, 402, 704, 802, 804, and / or 806, of the guiding instrument by forcing two or more handle structures together. Thus, the one or more handles may permit easier placement or removal of the guiding instrument over or from the bone.
    Figure 9 illustrates a method for manufacturing a surgical guiding instrument. At block 902, the method includes designing the surgical guiding instrument to create a surgical instrument design, the surgical guiding instrument design comprising: a body including one or more clamps configured to attach the surgical guiding instrument to one or more parts of a bone, a first clamp of the one or more clamps comprises a snap-fit portion including a flexible structure for increasing a clamping force of the first clamp and allowing easy removal of the surgical guiding instrument from the bone, and at least one aperture for guiding a surgical instrument. At block 904, the method comprises manufacturing the surgical guiding instrument based on the surgical guiding instrument design. The surgical guiding instrument can be designed and / or manufactured according to preoperative planning procedures using patient-specific characteristics of a patient's bone discussed above.
    In some embodiments, the surgical guide instruments described above are made in part or in full by addition making, which permits the integration of patient-specific components (e.g., the body, one or more clamps, the apertures, etc.) that further increase the accuracy of the guide instruments. The patient-specific parts of the surgical guiding instruments can be designed based on patient-specific parts of a particular bone of a patient. The patient-specific parts of the surgical guiding instruments can be made by generating parts that are complementary to the patient-specific parts of the bone. For converting digital image information of the bone into a basic model, template, or template that at least partially shows the positive or negative form of at least a portion of the bone, any suitable technique known in the art can be used, such as a rapid prototyping technique.
    Rapid prototyping and fabrication (RP & M) can be defined as a group of techniques used to quickly fabricate a scale model of an object, typically using three-dimensional (3D) computer-controlled design (CAD) data of the object. A variety of fast prototyping techniques are currently available, including stereolithography (SLA), selective laser sintering (SLS), molten deposition modeling (FDM), foil-based techniques, etc.
    A common characteristic of these techniques is that objects are typically built up layer by layer. Stereolithography, currently the most widely used RP & M technique, uses a barrel of a liquid photopolymer resin to build an object one layer at a time. On each layer, an electromagnetic beam, e.g., one or more laser beams that are computer-controlled, traces a specific pattern on the surface of the liquid resin defined by the two-dimensional cross-sections of the object to be formed. Exposure to the electromagnetic beam cures or solidifies the pattern traced on the resin, and attaches it to the layer underneath. After a coating has been polymerized, the platform sinks with a single layer thickness and a subsequent layer pattern is traced, thereby adhering to the previous layer. A full 3D object is formed by this process.
    Selective laser sintering (SLS) uses a high power laser or other focused heat source to sinter or weld small particles of plastic, metals, or ceramic powders into a mass that represents the 3-dimensional object to be formed.
    Molten deposition modeling (FDM) and related techniques use a temporary transition from a solid material to a liquid state, usually due to heating. The material is driven through an extrusion nozzle in a controlled manner and deposited at the required location as described, for example, in U.S. Pat. Pat. No. 5,141,680, the entire disclosure of which is incorporated herein by reference.
    Foil-based techniques attach coatings to each other by gluing or photopolymerization or other techniques and cut the object from these coatings or polymerize the object.
    Typical RP & M techniques start a digital representation of the 3D object to be formed. In general, the digital representation is cut into a series of cross-sectional layers that can be superimposed to form the object as a whole. The RP & M device uses this data for building the object on a layer by layer basis. The cross-sectional data representing the layer data of the 3D object can be generated using a computer system and computer-controlled design and manufacturing (CAD / CAM) software.
    A selective laser sintering device (SLS) can be used to manufacture a surgical guiding instrument template instead of a computer model. However, it is to be understood that various types of rapid manufacturing and instrumentation can be used to accurately fabricate these surgical templates including, but not limited to, stereolithography (SLA), molten deposition modeling (FDM) or milling.
    The surgical guiding instruments described above (or parts thereof) can be manufactured using various materials. In some embodiments, only materials are used that are biocompatible (e.g., USP class VI compatible) with the human body. In some embodiments, a surgical guiding instrument template can be formed from a heat-tolerant material, thereby allowing a high temperature sterilization to be tolerated. In some embodiments, if SLS is used as an RP & M technique, the surgical guide instrument template can be fabricated 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 described herein can be implemented as a method, device, or article of manufacture using standard programming or engineering techniques to manufacture software, firmware, hardware, or any combination thereof. The term "article of manufacture" as used herein refers to code or logically implemented hardware or non-perishable computer-readable media such as optical storage devices, and volatile or non-volatile memory devices or perishable computer-readable media such as signals, carriers, etc. Such hardware may include, but is not limited to, field programmable gate sequences (FPGAs), application-specific integrated circuits (ASICs), complex programmable logic devices (CPLDs), programmable logic sequences (PLAs), microprocessors, or other similar processing devices.
    It will be understood by those skilled in the art that many variations and / or modifications may be made to the invention without departing from the spirit or the. scope of the invention as broadly described. The embodiments described above must therefore be considered in all respects as illustrative and not restrictive.
    权利要求:
    Claims (13)
    [1]
    Conclusions
    A surgical guidance instrument for a bone, comprising: a body comprising: one or more clamps configured to attach the surgical guidance instrument to one or more parts of the bone, a first clamp of the one or more clamps snap-fit flexible structure portion for increasing the clamping force of the first clamp and allowing easy removal of the surgical guiding instrument from the bone, the flexible structure of the snap-fit portion comprising a material having a thickness between 1 / 2 and 1/5 of the average thickness of the rest of the body; and at least one opening for guiding a surgical instrument.
    [2]
    The surgical guiding instrument of claim 1, wherein the flexible structure of the snap-fit portion comprises at least one circuit connected between a first portion of the first clamp and a second portion of the first clamp.
    [3]
    The surgical guiding instrument of claim 2, wherein the at least one chain comprises at least one cylinder that adds rigidity to the at least one chain.
    [4]
    The surgical guiding instrument of claim 1, wherein the flexible structure of the snap-fit portion comprises a honeycomb structure including a plurality of holes that add flexibility and rigidity to the flexible structure.
    [5]
    The surgical guiding instrument of claim 1, wherein the body further comprises a first portion configured to attach the surgical guiding instrument to one or more osteophytes on the bone
    [6]
    The surgical guiding instrument of claim 5, wherein the bone is a femur.
    [7]
    The surgical guiding instrument of claim 5, wherein the first part comprises a flexible snap-fit part for increasing a clamping force of the first part to the bone and allowing easy removal of the surgical guiding instrument from the bone.
    [8]
    The surgical guiding instrument of claim 1, wherein the bone is a femur.
    [9]
    The surgical guiding instrument of claim 8, wherein the one or more parts of the bone for which the one or more clamps have been configured to attach the surgical guiding instrument comprises at least one joint nib of the distal end of the femur.
    [10]
    The surgical guiding instrument of claim 1, wherein the flexible structure comprises a flexible material.
    [11]
    A femoral surgical guiding instrument for a distal end of a femur, comprising: a body comprising: a front portion formed to attach the surgical guiding instrument to one or more osteophytes on the front portion of the femur; one or more clamps formed for attaching the surgical guiding instrument to one or more thigh bone joint nodules; and at least one opening for guiding a surgical instrument.
    [12]
    The femoral surgical guiding instrument according to claim 11, wherein a first clamp of the one or more clamps comprises an undercut portion formed to hook onto a first joint lump of the one or more joint lumps.
    [13]
    The femoral surgical guiding instrument according to claim 11, wherein a first clamp of the one or more clamps comprises a snap-fit portion, comprising a flexible structure for increasing the clamping force of the first clamp and allowing easy removal of the surgical guiding instrument of the bone.
    类似技术:
    公开号 | 公开日 | 专利标题
    JP6502553B2|2019-04-17|Surgical guide based on implant scan data
    US20190223885A1|2019-07-25|Patient-specific femoral guide
    BE1021358B1|2015-11-05|SURGICAL GUIDANCE INSTRUMENTS AND SYSTEMS AND METHODS FOR MANUFACTURING SURGICAL GUIDANCE INSTRUMENTS
    US8852198B2|2014-10-07|Surgical guiding tool, methods for manufacture and uses thereof
    Krishnan et al.2012|A review of rapid prototyped surgical guides for patient-specific total knee replacement
    EP2957239B1|2020-05-06|Customized patient-specific orthopaedic surgical instrumentation
    US9785747B2|2017-10-10|Method for designing a surgical guide
    US20150190145A1|2015-07-09|Customized Patient-Specific Bone Cutting Blocks
    EP2538864B1|2018-10-31|Customized patient-specific bone cutting blocks
    EP3205293A1|2017-08-16|Patient-modified implant and manufacturing method for such an implant
    BE1022556B1|2016-06-02|Surgical guiding devices with adjustable surface comprising stability and / or verification elements
    JP6045576B2|2016-12-14|Anatomically adapted patient alignment block
    WO2007097853A2|2007-08-30|Arthroplasty jigs and related methods
    WO2014090908A1|2014-06-19|Surgical guiding tools for orthopedic surgery and systems and methods of manufacturing the same
    US10456273B2|2019-10-29|Surgical cut validation tool and method
    D'Alessio et al.2019|3D printing for commercial orthopedic applications: advances and challenges
    AU2010272503B2|2015-05-21|Surgical guiding tool, methods for manufacture and uses thereof
    同族专利:
    公开号 | 公开日
    WO2014033125A1|2014-03-06|
    US9339281B2|2016-05-17|
    US20140058466A1|2014-02-27|
    US20150157343A1|2015-06-11|
    EP2892444B1|2017-12-27|
    EP2892444A1|2015-07-15|
    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    US20110015639A1|2006-02-27|2011-01-20|Biomet Manufacturing Corp.|Femoral Acetabular Impingement Guide|
    US20110015637A1|2009-07-17|2011-01-20|Materialise N.V.|Surgical guiding tool, methods for manufacture and uses thereof|
    WO2011110374A1|2010-03-10|2011-09-15|Depuy Orthopadie Gmbh|Orthopaedic instrument|
    EP2529677A1|2011-05-30|2012-12-05|Materialise NV|Patient-specific surgical guiding tools, methods for manufacture|
    US5141680A|1988-04-18|1992-08-25|3D Systems, Inc.|Thermal stereolighography|
    BRPI1014188A2|2009-05-07|2016-08-02|Smith & Nephew Inc|Patient-specific alignment guide for a proximal femur|
    US8668700B2|2011-04-29|2014-03-11|Biomet Manufacturing, Llc|Patient-specific convertible guides|
    US9066734B2|2011-08-31|2015-06-30|Biomet Manufacturing, Llc|Patient-specific sacroiliac guides and associated methods|EP2775943B1|2011-10-28|2015-03-18|Materialise N.V.|Guides with pressure points|
    ES2581777B1|2015-03-06|2017-08-03|Santiago JIMENEZ CARABALLO|Guide device for fibula cutting|
    US11033333B2|2017-04-06|2021-06-15|Stryker European Holdings I, Llc|Plate selection user interface and design tool with database|
    EP3424452A3|2017-06-16|2019-05-08|Stryker European Holdings I, LLC|Patient-specific bridging plates|
    US10849665B2|2018-10-29|2020-12-01|Stryker European Operations Holdings Llc|Snap-fit cutting guides and plating systems|
    法律状态:
    优先权:
    申请号 | 申请日 | 专利标题
    US201261693525P| true| 2012-08-27|2012-08-27|
    US61/693525|2012-08-27|
    [返回顶部]