Surgical guiding devices with adjustable surface comprising stability and / or verification elements

专利摘要:
The present application relates to adjustable surface surgical guide devices, tools, devices, or guides comprising stability and / or verification elements for use in surgical applications. In one embodiment, a surgical guiding device includes one or more rigid members configured to adhere to a first region of an underlying anatomical surface; a variably deformable portion coupled to said rigid members, and a soft tissue penetrating member configured to penetrate and adhere soft tissue overlying a third region of the underlying anatomical surface to the underlying anatomical surface.
公开号:BE1022556B1
申请号:E2015/5083
申请日:2015-02-13
公开日:2016-06-02
发明作者:Benjamin Geebelen
申请人:Materialise Nv；
IPC主号:

专利说明:

Surgical control devices with adaptable surface comprising stability and / or verification elements
Background
The present application relates to adaptive surface surgical guiding devices, devices, devices, or guides (hereinafter "device" or "devices") comprising stability and / or verification elements for use in surgical applications. This application also relates to methods for production of the adaptive surface surgical guidance device comprising stability and / or verification elements and methods for using the adaptable surface surgical guidance device comprising stability and / or verification elements in surgery.
Surgical guiding devices can be widely used in orthopedic surgery. Surgical guiding devices can accurately implement a pre-operative surgical plan in the operating room. Furthermore, surgical guiding devices can assist in guiding a surgical instrument, such as a cutting or drilling instrument, along a predefined cutting or drilling path.
However, creating a surgical guiding device that includes one or more views of an anatomical surface using pre-operative medical imaging data is not possible. For example, various anatomical surfaces may include soft tissue that is not visible in certain types of medical images, such as x-ray images. Additionally, anatomical surfaces may differ with regard to their shape from what is seen on the medical images. Ultimately, modeling errors can lead to representations that deviate from the underlying anatomical surface. As a result, it is possible that a surgical guiding device will not fit well on an anatomical surface (s) of the patient and may therefore be unstable. An unstable surgical guiding device can lead to an inaccurate guiding position for a surgical instrument, which is undesirable.
In addition to the difficulty of creating surgical guiding devices that include precise views of anatomical surfaces, the underlying anatomical surfaces may themselves lack surfaces that can be used to stabilize a surgical guiding device. For example, the underlying anatomical surfaces themselves may not have a stimulating effect on supporting a surgical guiding device. Similarly, the underlying anatomical surface may be covered by soft tissues, which may interfere with the surgical guiding device to adhere securely to the underlying anatomical surface.
In view of these and other deficiencies, there is a need for adaptive surface surgical guidance devices comprising stability and / or verification elements that provide firm and stable adhesion to an anatomical surface.
Summary
Different implementations of systems, methods and devices within the scope of the appended claims each have different aspects, none of which is solely responsible for the desirable features described herein. Without limiting the scope of the appended claims, some prominent features are described herein.
The present application generally relates to surgical guiding devices that may be patient-specific. Details of one or more implementations of the subject matter described in this application are set forth in the accompanying figures and the following description. Other features, aspects, and advantages will become apparent from the description, the figures, and the claims.
An aspect of the subject matter described in the disclosure provides a surgical guiding device. The surgical guiding device comprises one or more rigid portions configured to adhere to a first region of an underlying anatomical surface; a variably deformable portion coupled to the one or more rigid portions, the variably deformable portion being configured to conform to a shape of a second region of the underlying anatomical surface; and a soft tissue penetrating element configured to penetrate into soft tissue that overlies a third area of the underlying anatomical surface and to adhere to the underlying anatomical surface.
Brief description of the figures
The following description of the figures is only exemplary in nature and is not intended to limit the present descriptions, their application, or their uses. For all figures, corresponding reference numbers indicate similar or corresponding parts and features. Note that it is possible that the relative dimensions of the following figures are not shown to scale. FIG. 1a illustrates an exemplary front view of a femur. FIG. 1b illustrates an exemplary rear view of the femur of FIG. 1a. FIG. 1c illustrates examples of alternative views of the femur of FIG. 1a, comprising a bottom view A, a bottom perspective view B, and a top perspective view C. FIG. 2a illustrates a front perspective view of an example of a surgical guiding device in accordance with some embodiments. FIG. 2b illustrates a front view of an example of a variably deformable portion of the surgical guiding device of FIG. 2a in accordance with some embodiments. FIG. 2c illustrates a front perspective view of another example of a surgical guiding device in accordance with some embodiments. FIG. 2d illustrates a front view of an example of a variably deformable portion of the surgical guiding device of FIG. 2c in accordance with some embodiments. FIG. 3a illustrates a front perspective view of an example of a surgical guiding device in accordance with some embodiments. FIG. 3b illustrates a front view of an example of a variably deformable portion of the surgical guiding device of FIG. 3a in accordance with some embodiments. FIG. 3c illustrates a front perspective view of another example of a surgical guiding device in accordance with some embodiments. FIG. 3d illustrates a front view of an example of a variably deformable portion of the surgical guiding device of FIG. 3c in accordance with some embodiments. FIG. 4a illustrate a bottom view of another example of a surgical guiding device in accordance with some embodiments. FIG. 4b illustrates a rear view of the surgical guiding device of FIG. 4a in accordance with some embodiments. FIG. 5a illustrates a view of a variably deformable portion of a surgical guiding device in accordance with some embodiments. FIG. 5b illustrates a view of a surgical guiding device in accordance with some embodiments. FIG. 6a illustrates a view of a surgical guiding device in accordance with some embodiments. FIG. 6b illustrates a view of a surgical guiding device in accordance with some embodiments. FIG. 7a illustrates a view of a surgical guiding device in accordance with some embodiments. FIG. 7b illustrates a view of a surgical guiding device in accordance with some embodiments. FIG. 8a illustrates a view of another embodiment of a surgical guiding device with adjustable surface 800 including an associated slot. FIG. 8b illustrates a view of an embodiment of a surgical guiding device with adaptable surface 800 comprising a guide for resection installed in an associated slot. FIG. 9 illustrates an embodiment of an adjustable surface surgical guiding device comprising a soft tissue penetrating pin. FIG. 10 illustrates another embodiment of an adjustable surface surgical guiding device comprising a soft tissue penetrating pin. FIG. 11 illustrates an aspect of a method for producing a surgical guiding device. FIG. 12 is an example of a system for designing and producing 3D objects. FIG. 13 is a functional block diagram of an example of a computer of FIG. 6. FIG. 14 is a process for the production of a 3D object.
Detailed description
The following detailed description is directed to certain specific embodiments. However, the descriptions herein can be applied in a variety of different ways.
The present invention will be described with respect to certain embodiments, but the invention is limited only by the claims.
As used herein, the singular forms "a" and "the" include both singular and plural references unless the context clearly dictates otherwise.
The terms "comprising", "includes", and "consisting of" as used herein are synonymous with "including", "includes", or "containing", "contains", and are inclusive or open-ended and do not include additional , non-enumerated parts, elements or process steps. The terms "comprising", "comprises", and "consisting of" when reference is made to enumerated components, elements or process steps, also include embodiments which are "composed of" said enumerated components, elements or process steps.
Furthermore, the terms "first", "second", "third", and the like are used in the description and in the claims to distinguish between comparable elements and not necessarily for describing a consecutive or chronological order, unless it is It is to be understood that such terms are interchangeable under suitable conditions and that the embodiments of the invention described herein are capable of being carried out in an order different from that described or illustrated herein.
Reference throughout this specification to "an embodiment," "some aspects," or "an aspect" means that in connection with the embodiment or aspect, a particular structure, feature or feature is described that is contained in at least one of the embodiments of the present invention are included. Thus, appearances of the phrases "in one embodiment," "some aspects," or "one aspect" at different places in this specification do not necessarily refer to the same embodiment or aspects. Furthermore, the particular structures or features may be combined in any suitable manner in one or more embodiments or aspects, as will be apparent to one skilled in the art of this disclosure. While some embodiments or aspects described herein include some but not other features included in other embodiments or aspects, further combinations of features of different embodiments or aspects are considered to be within the scope of the invention. For example, in the appended claims, any of the features of the embodiments or aspects described in the claims can be used in any combination.
The present application discloses a surgical guiding device with adjustable surface comprising stability and / or verification elements. One or more aspects of the surgical guiding devices may be patient-specific. The surgical guiding devices are designed to provide accurate and stable adhesion to an underlying anatomical surface, such as a bone. By providing accurate and stable adhesion to an anatomical surface, it becomes possible to implement precise surgical procedures, such as the precise introduction of a surgical instrument into a specific part of a bone. As used herein, the term "bonding", "bonding", and / or any variation thereof, refers to the placement, connection, or contacting of an object on or with another object. For example, a surgical guiding device "adhered to a bone" (or other anatomical surface) may refer to the placement of the device on the bone, the structure of the bone holding the device in place. As another example, a surgical guiding device "that adheres to a bone" (or other anatomical surface) may also refer to the attachment of the device to the bone using one or more clamps, screws, connectors, adhesives, and the like. As yet another example, a surgical guiding device "attached to a bone" (or other anatomical surface) may refer to the attachment of the device to the bone using both placement and / or shape of the device as well as one or more suturing devices (e.g., clamps, screws, connecting elements, and the like).
In some embodiments, one or more aspects of a surgical guiding device may be based on data relating to underlying anatomical surfaces of a patient (such as medical images) and are therefore sometimes referred to as "patient-specific". The term "patient-specific", as used herein with reference to surgical devices, may refer to aspects of surgical devices, devices, devices, and / or guides designed based on a separate anatomy of the patient to provide customization and / or a function for the particular patient The patient-specific nature of the surgical guiding device allows customization of the surgical guiding device with the underlying anatomy of the patient and increases the ability to perform precise surgical procedures on the patient. , devices, or guides, therefore, allow improved surgical interventions, orthopedic structures, and / or kinematics for the patient.Additionally, similar benefits can be obtained when patient-specific devices in combination with standard implants, devices, devices, surgery chemical procedures, and / or other methods are used.
In some embodiments, patient-specific surgical guiding devices may be based on pre-operative procedures. For example, pre-operative procedures can identify different areas of a specific anatomy of the patient and, based on the identified areas of the anatomy, a patient-specific design for different components of a surgical guiding device (e.g., flexible and / or rigid parts, deformable couplings , clamps, apertures, and the like). Pre-operative procedures may also, based on the identified areas of the patient's anatomy, determine the preferred locations on the patient's anatomy for attaching a surgical guiding device.
Pre-operative procedures may involve obtaining an image of an anatomy of the patient prior to performing surgery. Digital patient-specific image information can be provided by any suitable means known in the art, such as, for example, an X-ray machine, a computed tomography (CT) scanner, a magnetic resonance imaging (MRI) scanner, an ultrasound scanner, and the like. Pre-operative planning may include, for example, the construction of a two-dimensional (2D) image or a three-dimensional (3D) virtual model of an anatomical object, surface, or other part thereof.
A virtual 3D model of an anatomical surface of the patient can be created using statistical methods described in more detail below from 2D images, such as X-rays. In some embodiments, the construction of the virtual 3D model of an anatomical object can begin with scanning a patient. Scanning may include the use of a scanning technique that generates medical imaging data, such as a CT scan, an MRI scan, and the like. In some embodiments, the output of the scan may include a stack of 2D slices that form a 3D data set. The output of the scan can be digitally imported into a computer program and can be converted into a 3D computer model of an anatomical object using statistical algorithms known in the field of image processing technology. For example, the virtual 3D model can be constructed from the data set using a computer program such as Mimics ™ as supplied by Materialize N.V., Leuven, Belgium.
In some embodiments, in a fitting method, a simulated model can be used to create a virtual 3D model of an anatomical object based on 2D image segments of the anatomical object, such as a bone. For example, a simulated model of an anatomical object can be compared to medical images of an anatomy of the patient in order to generate a 3D model of the anatomy of the patient. As discussed above, the medical images may include CT scan images, X-ray images, MRI images, and the like.
A simulated model of an anatomical object can be used because it is possible that one or more medical images of an anatomy of the patient alone do not include sufficient information to build a reliable 3D model of the underlying anatomy of the patient. Accordingly, in order to build a reliable 3D model, the simulated model, including anatomical knowledge relating to the object in the medical image, can be used to interpret the image. For example, a simulated model may include a statistical shape model (SSM) and the anatomical knowledge may be condensed in the SSM to display the anatomical object. The SSM can be a 2D or 3D model and can correspond to a theoretically expected object with similar characteristics to that of a patient's anatomy (for example, a patient's bone). An SSM can therefore be used in a fitting method for generating a 3D model of an anatomy of the patient by comparing and matching the SSM with the one or more medical images of an anatomy of the patient.
In some embodiments, an iterative process for a closest point, or a variant thereof, can be used to generate a 3D model of a patient's anatomy. The comparison or fitting of the SSM with the one or more medical images of an anatomy of the patient can be performed, for example, by aligning the SSM with an anatomical object in the medical images. The alignment may be performed, for example, by selecting points whose different data points on the SSM correspond to data points on the medical image. Various methods of fitting can be used. The matching may be performed, for example, by determining the closest points on the medical image relative to related points on the SSM. Furthermore, different translations and rotations of the SSM relative to the medical image can be tested in order to link appropriate points, features, and the like, to each other, and to align the SSM and the medical image data. The process can iteratively select and link points on the SSM and the medical image and minimize the distance between corresponding points on the SSM and the medical image to redefine the 3D model of an anatomy of the patient. The result of the alignment process is an accurate 3D model of an anatomical object.
In some embodiments, the 3D model of an anatomical object can be generated based on 3D imaging techniques, such as segmentation of 3D image data to create the 3D model. For example, various 3D images of the anatomical object can be obtained (e.g., by magnetic resonance imaging (MRI) or computed tomography (CT) imaging) and segmented to create the 3D model. In some aspects, the 3D model can be based on a 3D reconstruction of CT or MRI images.
Once the 3D model of an anatomical object, such as a bone or a part thereof, has been reconstructed, the preferred position, orientation, and specific surgical preferred parameters required for surgery can be defined. For example, the depth and diameter of drill holes and drill paths on a bone can be defined. Based on the bone 3D model, a surgical guiding device can be designed, produced, and / or manipulated to meet the needs of the specific patient.
Creating an accurate representation of a patient's anatomy using pre-operative medical imaging data is not always possible. For example, one or more regions of an anatomical object (such as a bone) may include soft tissue (e.g., cartilage, muscles, tendons, ligaments, and the like), which may not be visible using certain medical imaging methods. For example, cartilage may not be visible in X-ray and CT images. But soft tissues, such as cartilage, can cover much of an area that requires surgery. While the thickness of the soft tissue can be estimated, the estimates may not be accurate enough to use these soft tissue regions for attachment points for a surgical guiding device. As a result, it may not be possible that, due to the limited areas of the bone that are visible in the medical image (s), it is not possible to achieve an optimum position or area on an anatomical surface (such as a bone) for suturing the surgical guide device.
Anatomical surfaces may further differ in their shape from what is seen on the medical images. As a result, surgical guiding devices designed on the basis of such medical images may be less stable while in use. Similarly, the anatomical surface represented in a 3D model created using the statistical modeling methods described above may include variable accuracy regions due to various types of errors in the modeling process (described in more detail below) . Accordingly, rigid surgical guidance created on the basis of inaccurate modeling based on medical imaging and / or statistical modeling may have variable spaces when it adheres to an anatomy of the patient and may therefore have an unstable fit when it adheres to the anatomy of the patient. For example, if a portion of an underlying anatomy is not visible in an image (e.g., due to soft tissue regions in the bone), a rigid guide over a tilting point, possibly present in the actual anatomical surface, may pivot and an unstable during use and / or create a reciprocating fit.
An accuracy map can be generated and used to determine the accuracy of different areas of a modeled anatomical object. An accuracy map provides an indication of how accurate or certain the modeling result is at each point of a model of an anatomical object (such as a 3D model) and can give an indication of the reliability of each point of the surface. In some embodiments, a standard deviation (s) can be used to model the accuracy, and the accuracy map can indicate the standard deviation at each point.
As described above, there are different sources of an error that can occur when generating the 3D model, and therefore there can be several different accuracy maps. An example of a source of an error is the data input error, such as image data that due to the nature of the acquisition and measurement of the data (e.g., limits of the accuracy of imaging device, limits of the capabilities of the imaging device, and the like) may have limited accuracy. Another example of a source of an error is inaccuracies due to errors in fitting a simulated model related to the anatomical object, such as an SSM, with the image data (e.g., misalignment of the SSM with the X-ray, incompleteness of the SSM itself, and the like). Yet another example of an error source is inaccuracies due to missing data in the images (for example, the input of 2D image data cannot provide enough data to accurately represent each component of an anatomical object). A fourth example of a source of an error is incompleteness of the SSM itself, such as missing parts because the SSM is condensed. Individual accuracy maps can be combined into a total accuracy map. The combined or individual accuracy maps contain an accuracy or assurance level at each point of a 3D model of an anatomical surface, such as a bone.
As indicated above, specific areas of an anatomical object (such as a bone) can include specific anatomical features that can be used to attach a surgical guiding device. Patient-specific anatomical data (such as medical images) can be used in the design of surgical guiding devices to identify surfaces of a bone that are most suitable for attachment. But as explained above, using pre-operative medical imaging data and / or statistical modeling can be difficult to create an accurate representation of an anatomical surface. An anatomical surface may, for example, comprise a highly variable surface that cannot be accurately captured as an image. As a result, despite being patient-specific, a surgical guiding device still cannot fit on the underlying anatomical surface in a fixed and stable manner. Accordingly, despite the underlying accuracy of a model of the anatomical object, a surgical surface-guided surgical device can be designed that includes deformable portions designed for a fixed adhesion to an anatomical surface.
In some embodiments, the deformability of a deformable portion of a surgical guiding device varies between different points of the deformable portion relative to an amount of variability of the underlying anatomical surface. In some embodiments, the deformability of a deformable portion may be relatively greater at points where the variability of the underlying anatomical surface and / or the inaccuracy of the model of the underlying anatomical surface is relatively greater. For example, a region of a bone can have a highly variable surface and can include large amounts of overlying soft tissue that does not appear in a medical image. As a consequence, the portion of the deformable portion designed to adhere to that area of the bone can be highly deformable or flexible such that it can conform to the area despite the soft tissue and / or the variable surface.
Additionally, in some embodiments, the deformability of a deformable portion of a surgical guiding device may be specific to a given direction relative to the underlying anatomical surface. As an example, certain points of the variably deformable portion can only be compressible in a certain direction (e.g. perpendicular to the surface of an anatomical surface) and not in other directions. Accordingly, an adaptable surface surgical guiding device can securely adhere to uneven and / or variable surfaces of an anatomical object (such as a bone), even in the absence of an accurate image or model of the anatomical object.
A method for producing an adjustable surface surgical guide device may include creating a design for an adjustable surface surgical guide device. The adaptable surface surgical guiding device may be designed, for example, using medical images of a patient's anatomy and / or statistical modeling as described above.
An adaptable surface surgical guiding device design may include one or more rigid portions configured to attach to a first region of an underlying anatomical surface, and a variably deformable portion coupled to the rigid portion and configured to attach to a second region of the underlying anatomical surface. As described above, the term "bonding", and / or any variation thereof, may refer to the placement, connection, or contacting of a rigid portion or a deformable portion of a surgical guiding device on or with an anatomical surface .
A shape of a rigid portion may, for example, correspond to the structure of an anatomical object (such as a bone) so that the rigid portion may adhere to a first region of the anatomical object, e.g., by applying pressure to the rigid portion in the direction of the anatomical object. In another example, a rigid portion of a surgical guiding device can attach itself to an anatomical object (such as a bone) using an attachment device such as one or more clamps, screws, connectors, adhesives, and the like.
A variably deformable portion may be configured to conform to a shape of a second region of an anatomical object (such as a bone) to provide stable adhesion of the surgical guiding device to the anatomical object. A variably deformable portion may, for example, adhere to a second region of the bone, for example by applying pressure to the deformable portion in the direction of the anatomical object.
In some embodiments, a variably deformable portion may be designed to conform to a surface of an anatomical object as approximated and represented in a model of the anatomical object (e.g., an SSM).
Accordingly, in some embodiments, the variably deformable portion may not exactly conform to the underlying anatomical surface if one or more regions of the surface were not accurately modeled, but it may be flexible enough to still provide firm and stable adhesion to the anatomical surface.
Accordingly, surgical guiding devices that include one or more adjustable surfaces capable of providing a firm and stable bone adhesion are desirable. An advantage of the surgical guiding devices described in the present application provides that on the basis of each type of imaging and / or modeling technology and on the basis of each underlying anatomical surface, sufficient information can be obtained for designing a surgical guiding device for fixed and stable placement on an anatomical surface of a patient. FIG. 1a illustrates a front view of an example of a femur 100. While the description herein describes the femur 100, it will be apparent to one skilled in the art that the content of this disclosure relates in a manner similar to other bones such as the humerus, shoulder blade, tibia, fibula, jump leg, and other shoulder, hip, ankle, and / or finger bones. The front region shown in FIG. 1a is illustrated, is located at the distal end of femur 100. This anterior region of femur 100 may include a portion 102 that can be used to attach and secure a surgical guiding device thereto. For example, an osteophyte is a bony protrusion formed on bones, such as a joint, and it can occur in patients with arthritis. One or more osteophytes projecting from the surface of thigh 100 may provide a surface to which a surgical guiding device may attach (in whole or in part). As another example, a medial articular node 108 and a lateral articular node 110 are located at the distal end of the femur 100, and these can also be used to attach a surgical guiding device thereto. Additionally, using a surgical device (e.g., a surgical drill) inserted into one or more apertures of a surgical guiding device, holes 104 and 106 can be created. FIG. 1b illustrates an exemplary rear view of the femur 100 of FIG. 1a. FIG. 1b illustrates the medial joint lump 108 and lateral joint lump 110 located at the distal end of the femur 100. FIG. 1c illustrates examples of alternative views of femur 100 illustrated in FIG. 1a, including a bottom view A, a bottom perspective view B, and a top perspective view C. FIG. 1c illustrates in particular medial joint lump 108 and lateral joint lump 110 located at the distal end of femur 100. The medial 108 and lateral 110 joint nodules can provide one or more parts that can be used to attach and secure a surgical guiding device thereto. For example, a lateral region 112 and a medial region 114 of the medial articulation knuckle 108 can be used to attach and secure a surgical guiding device. In some embodiments, lateral and medial regions of the lateral joint node 110 may be used to attach and secure a surgical guiding device. For example, in addition to lateral region 112 and medial region 114 of medial joint lump 108, lateral and medial regions of lateral joint lump 110 may be used to attach a surgical guiding device to femur 100. As another example, only the lateral and medial regions of lateral joint node 110 can be used as an alternative to lateral region 112 and medial region 114 of medial joint node 108. In some embodiments, osteophytes located on medial articular node 108 and / or lateral articular node 110 can be used to attach and secure a surgical guiding device. FIG. 2a illustrates a front perspective view of an example of a surgical guide device with adjustable surface 200 configured to attach to a bone. In some embodiments, the adjustable surface surgical guide device 200 may be a femoral surgical guide device with adjustable surface for attaching to a distal end of a femur 212. Note that while the description herein relates to femur 212 as an example of an anatomical surface , it will be apparent to one skilled in the art that the content of this disclosure is in a manner similar to other anatomical surfaces, such as a humerus, shoulder blade, tibia, fibula, jump bone, vertebra, and other shoulder, hip, ankle and / or finger bones applies. Additionally, a surgical surface-guided surgical device may also be designed for attachment to other anatomical surfaces including external parts of a patient, such as an arm, leg, lower abdomen, back, foot, hand, or other body part.
The surgical guiding device with adjustable surface 200 comprises an adjustable surface comprising a rigid portion 202 and a variably deformable portion 204 coupled to the rigid portion 202. In some embodiments, the rigid portion 202 and the variably deformable portion 204 may be produced as separate structures. In other embodiments, the rigid portion 202 and the variably deformable portion 204 may be produced as a single structure with varying thicknesses and patterns, for example using the 3D printing techniques described below.
The rigid portion 202 of the surgical guiding device with adjustable surface 200 may optionally attach to a first portion of the femur 212. The rigid portion 202 may, for example, attach to the anterior region of the femur 212, as well as to the lower portion of the femur 212 comprising the medial joint knob 108 and the lateral joint knob 110 (as illustrated in Figures 1a-c). In some embodiments, the rigid portion 202 attaches to the femur 212 through the variably deformable portion 204. The variably deformable portion 204 may, for example, attach to the femur 212, and the rigid portion 202 may attach to the variably deformable portion 204. The rigid portion 202 can provide strong adhesion to well-defined areas of the femur 212.
For example, the rigid portion 202 may be designed such that the rigid portion 202 does not easily bend when an object comes into contact with the rigid portion 202 or when the rigid portion 202 contacts the surface of the femur 212. Similarly, the rigid portion 202 are designed so that it is stable enough that a physician can operate through a portion of the rigid portion 202 without moving the rigid portion 202, such as when a drill or other surgical instrument is guided through an aperture in the rigid portion 202.
In some embodiments, the rigid portion 202 may fixate to the femur 212 in a fixative manner. In other embodiments, the rigid portion 202 can attach to the femur 212 by resting on the femur 212. In these embodiments, as further described below, one or more clamps can be used to secure the surgical guide device with adjustable surface 200 to the femur.
While only a single rigid portion in FIG. 2a, it will be apparent to one skilled in the art that the surgical guide device with adjustable surface 200 can include one or more rigid portions. In some embodiments, the surgical guiding device with adjustable surface 200 may comprise a plurality of rigid portions or structures, one or more of the rigid portions being adhered to the femur 212 and one or more of the rigid portions not being adhered to the femur 212. For example, one or more of the rigid portions not adhered to the femur 212 may be used to connect two or more rigid portions adhered to the femur 212. In another example, one or more rigid apertures can be coupled to the rigid portion 202 and / or the variably deformable portion 204.
The well-defined areas of the femur 212 according to which the rigid portion 202 is designed to adhere may be clear in medical images and may be accurately modeled using the pre-operative and statistical methods described above for designing the surgical guiding device with adjustable surface 200. As a result, the areas of a 3D model of femur 212 that correspond to these well-defined areas can be used to accurately design the rigid portion 202 for attachment to those areas with minimal number, or without mistakes. FIG. 2b illustrates a front view of an example of the variably deformable portion 204 of the adjustable surface surgical guide device 200. The variably deformable portion 204 may be designed to conform to a shape of the other areas of the femur 212 that are less well defined and therefore less accurately depicted in the 3D model of the femur 212. The variably deformable portion 204 may, for example, be designed such that it can be deformed in three dimensions relative to the femur 212. The less well-defined regions may be depicted less accurately in the 3D model due to lack of detail in a medical image (for example, due to soft tissue that forms large parts of the femur 212, and the like), inaccuracies in the 3D model, and the like. The variably deformable portion 204 is thus able to fit on the underlying variable anatomical surface to create a stable fit and proper orientation for the surgical guiding device with adjustable surface 200. The stable part 202 can therefore meet the more accurately modeled areas of attach the femur 212 to obtain most of the appropriate positioning, and the variably deformable portion 204 can attach to the more variable, less defined regions in the 3D model to achieve stability of the surgical guide device with adjustable surface 200 during use.
In some embodiments, the variably deformable portion 204 increases surface contact with the underlying surface of the femur, and thus can be used to increase the stability of the surgical guide device with adjustable surface 200 without the risk of creating a tipping point. In some embodiments, the variably deformable portion 204 may conform to the anterior region of the femur 212 as well as to the lower region of the femur 212, including the medial articular node 108 and lateral articular node 110. In some embodiments, the variably deformable portion 204 conforms to a larger area of the front and parts of the femur 212 than the rigid portion 202 because in these areas that are less well defined and / or more variable there is more surface area.
The formability and / or flexibility of the variably deformable portion 204 can vary based on an amount of variability of the underlying surface of the femur 212 at different points of the variably deformable portion 204. For example, each point on the variably deformable portion 204 may have a different deformability characteristic based on the point on the femur 212 for which it is designed to adhere. The deformability and / or flexibility of the variably deformable portion 204 can increase at any given point as the variability or inaccuracy of the underlying anatomical surface becomes higher. For example, a large area of the femur 212 may include soft tissue that does not appear in a medical image. The same or a different region of the femur 212 can include a highly variable surface. The portion of the variably deformable portion 204 that is designed to adhere to that area of the femur 212 can therefore be highly deformable or flexible so that it can conform to the variable surface and / or soft tissue area of the bone, such as illustrated in FIG. 2b. As described in more detail below, different material thicknesses and / or patterns can be used to vary the flexibility of the variably deformable portion 204.
In some embodiments, the variably deformable portion 204 may be designed based on a best estimate of the expected underlying anatomical surface. For example, each point on the variably deformable surface 204 may be designed based on medical image data, statistical shape models, documented anatomical averages of the underlying surface, and / or one or more accuracy maps. An estimated anatomical model of variable accuracy can be used as an initial design point for the variably deformable surface 204. Due to the inaccuracy and / or variability of the estimated model of the underlying anatomical surface, the variably deformable surface 204 with varying flexibility, as described above, may be designed to conform to the surface.
An accuracy map can be used to determine a range of variability of the underlying anatomical surface of the femur 212. For example, a very inaccurate point on the accuracy map for the 3D model of the femur 212 can be correlated with a highly variable point on the surface of the femur 212 where the exact surface shape is unknown. The range of variability determined for the surface of the femur 212 can be used to create a variability map for the variably deformable portion 204. The variability map can include a deformability metric for each point of the variably deformable portion 204. The deformability metric for a given point on the variability map corresponds to the variability of a corresponding point on the surface of the femur 212. The variability map can then be applied to the variably deformable portion 204 so that each point of the deformable portion 204 is designed as being deformable relative to the deformability metric of a corresponding point on the variability map. Based on the application of the variability map, points of the variably deformable portion 204 designed to adhere to inaccurately modeled and / or variable areas of the surface of the femur 212 can be highly deformable so that the variably deformable portion 204 is independent of the surface variability will conform to that surface.
In some embodiments, an accuracy map and a corresponding variability map can be used to design the rigid portion 202. For example, a rigid portion 202 of the surgical guiding device with adjustable surface 200 may be designed to adhere to areas of the femur 212 that are shown very accurately in the 3D model, as evidenced by high levels of confidence in a corresponding accuracy map. Due to the precise nature of the 3D model for these areas, the rigid portion 202 can then adhere to these areas of the femur 212 with high accuracy.
The rigid portion 202 and the variably deformable portion 204 may comprise various materials selected on the basis of their flexibility, sterilization capability, biocompatibility, and / or other factors. Materials can, for example, comprise a hard plastic with flexible characteristics, such as a polyamide. As another example, the materials may comprise a rubber-like material, such as thermoplastic polyurethane. In some embodiments, the rigid portion 202 and the variably deformable portion 204 may be produced using the same materials. The rigid portion 202 can be produced with rigid features by increasing the thickness of the rigid portion 202 until the portion 202 is no longer easily movable. For example, the thickness of the rigid portion 202 may be designed so that the portion 202 does not easily flex when contacted with it or when the rigid portion 202 contacts the surface of the femur 212. The thickness of the rigid portion 202 may also be designed such be stable enough that a physician can operate through a portion of the rigid portion 202 without the rigid portion 202 moving, such as guiding a drill or other surgical instrument through an aperture in the rigid portion 202.
As noted above, the deformability and / or flexibility of the variably deformable portion 204 can vary at different points of the variably deformable portion 204 based on an amount of expected variability of the underlying surface of the femur 212. The varying formability and / or flexibility can be achieved by varying the thickness and / or pattern of the material used for the production of the variable formable portion 204. For example, the variably deformable portion 204 may be produced such that it is thinner than the rigid portion 202 so that the deformable portion 204 is capable of deforming and bending relatively easily. The variably deformable portion 204 can deform after making contact with the underlying surface of the femur 212 so that the deformable portion 204 conforms to the surface. In some embodiments, the pattern of the variably deformable portion 204 may also be designed such that the deformable portion 204 has certain flexible features.
The variably deformable portion 204 shown in FIG. 2b, for example, includes a plurality of holes through which the underlying anatomical surface of femur 212 is exposed. In some embodiments, the variably deformable portion 204 may be produced as a structure comprising one or more volumes filled with a space-filling substance (e.g., bubble, fluid bubble, and the like), a crystal lattice-like structure, one or more springs, and / or the like . The pattern of the holes, substance-filled volumes, crystal lattice, springs, and the like, allows, in addition to the flexibility provided by the thickness of the material used to produce the variably deformable portion 204, further flexibility. The holes may also allow a physician to observe the underlying anatomical surface of the femur 212.
The holes may have any shape, size, and the like, to achieve a desired flexibility or design.
The thickness and pattern of the material along different regions of the variably deformable portion 204 can be designed such that varying flexibility can be achieved in the different regions. For example, regions of the variably deformable portion 204 that are designed to adhere to less well-defined (e.g., inaccurately modeled) and / or highly variable regions of the femur 212 may include a certain thickness and pattern that provide greater flexibility than regions of the deformable portion 204 designed to adhere to better defined and less variable regions of the femur 212.
In some embodiments, different materials can be used for the rigid portion 202 and the variably deformable portion 204. For example, a hard plastic can be used to produce the rigid portion 202 and a rubber or soft plastic can be used to produce the variably deformable portion 204. It will be apparent to one skilled in the art that the content of this disclosure also applies in a similar manner to other materials that may be used to design and produce the rigid portion 202 and the variably deformable portion 204.
The rigid portion 202 shown in FIG. 2a can be configured to overlap with at least a portion of the variably deformable portion 204. For example, the variably deformable portion 204 can conform to a larger area of the anterior and lower portions of the femur 212 than the area to which the rigid portion 202 can adhere because there is more surface area in these areas that are less well defined and / or more variable. In some embodiments, the rigid portion 202 adheres only to the well-defined regions of the femur 212, while the variably deformable portion 204 adheres to both the well-defined and the non-well-defined regions.
The variably deformable portion 204 can be coupled to the rigid portion 202 according to various embodiments. In some embodiments, the variably deformable portion 204 and the rigid portion 202 can be directly coupled to each other. In other embodiments, the variably deformable portion 204 and the rigid portion 202 can be coupled using at least one deformable link. A deformable coupling may, for example, comprise a spring, a flexible clip, a flexible hinge, a flexible clamp, or any other flexible coupling that allows movement or adjustability in one or more directions. FIG. 2c illustrates a front perspective view of another example of the adjustable surface surgical guide device 200 comprising two deformable couplings 206. The deformable couplings 206 are designed to deform in an upward and downward direction toward and toward the rigid portion 202, and optionally in a left and right direction so that the fit of the surgical guiding device with adjustable surface 200 in the deformable couplings area can adjust to a variable lower surface of the femur 212. FIG. 2d illustrates a front view of the variably deformable portion 204 comprising the two deformable couplings 206. The deformable couplings 206 illustrated in Figures 2c and 2d include springs. One skilled in the art will appreciate that the malleable couplings can include any flexible coupler that allows movement or adjustability in one or more directions.
The variably deformable portion 204 and the rigid portion 202 can be coupled using at least one rigid coupling. In some embodiments, a rigid coupling may include a clip, hinge, clip, or any other rigid device. In some embodiments, a rigid coupling can be made from materials that are not easily movable on the basis of, for example, their thickness.
In some embodiments, the variably deformable portion 204, the rigid portion 202, and the one or more deformable couplings may be produced as separate structures. In some embodiments, the variably deformable portion 204, the rigid portion 202, and the one or more deformable couplings may be produced as a single structure with varying thicknesses and patterns, for example using the 3D printing techniques described below. For example, the entire surgical guide device with adjustable surface 200 can be produced with varying thicknesses and patterns as a single structure using 3D printing so that no separate parts need be produced.
In some embodiments, the surgical guiding device with adjustable surface 200 may be designed such that it includes one or more rigid portions in addition to the rigid portion 202. The additional rigid portions may comprise one or more apertures. The surgical guiding device with adjustable surface 200 may comprise, for example, one or more apertures in the rigid portion 202 and / or the variably deformable portion 204. The apertures may include a borehole, a cut-out slot, and the like, allowing a physician to pass surgical aids through the apertures. In some embodiments, two apertures may be placed in two different regions of the variably deformable portion 204, and those apertures may correspond to two regions of the femur 212 for which the surgery is intended. The apertures can be rigid enough that a physician can accurately drill through the apertures a hole in femur 212 without any movement of the apertures relative to femur 212. Specific examples of apertures will be discussed below with regard to FIG. 4a and 4b are discussed in more detail.
Figures 3a-3d illustrate another example of a surgical guiding device with adjustable surface 300 comprising a variably deformable portion 304 and a rigid portion 302. The variably deformable portion 304 comprises a different pattern than that of the variably deformable portion 204 of the surgical guiding device 200 that is illustrated in Figures 2a-2d. As such, the variably deformable portion 304 may be more flexible than the variably deformable portion 204 illustrated in Figures 2a-2d. Figures 3c and 3d additionally illustrate another example of a variably deformable portion 304 comprising two deformable couplings 306, which include springs that allow movement in an up and down direction. FIG. 4a illustrates a bottom view of another example of a surgical guiding device with adjustable surface 400. The bottom view of FIG. 4a corresponds to bottom view A of the femur 100 shown in FIG. 1c is illustrated.
The surgical guiding device with adjustable surface 400 comprises an adjustable surface comprising a rigid portion 402, a variable deformable portion 404, and clamps 408. The rigid portion 402 and the variable deformable portion 404 may be similar to those above with regard to FIGS. 2a-2d described rigid portion 202 and variably deformable portion 204. The rigid portion 402 may be designed to attach to a well-defined region of an anatomical object (e.g., a bone) to provide a firm and stable adhesion. The rigid portion 402 may, for example, adhere to the anterior region of a femur such as femur 100 in FIG. 1c. The rigid portion 402 can attach to the femur via the variably deformable portion 404. For example, the variably deformable portion 404 may be attached to the femur, and the rigid portion 402 may be attached to the variably deformable portion 404. The rigid portion 402 may be designed so that it does not bend easily when an object with the rigid portion 402 in comes into contact or when the rigid portion 402 makes contact with the surface of the femur. The rigid portion 402 may, for example, be stable enough for a physician to be able to pass surgical aids (e.g., a drill) through a portion of the rigid portion 402 without the rigid portion 402 moving relative to the femur.
In some embodiments, the rigid portion 402 can attach to the femur in a fixed manner. In other embodiments, the rigid portion 402 can attach to the femur by resting on the femur. In these embodiments, clamps 408 can be used to over-secure the surgical guide device with adjustable surface 400 to the femur. As described above, the well-defined areas of the femur according to which the rigid portion 402 is designed to adhere may be clear from medical images and may be accurately modeled using the pre-operative and statistical methods described above for designing the surgical guiding device with adjustable surface 400.
The variably deformable portion 404 may be designed to conform to surfaces of the femur that are less well defined and therefore less accurately depicted in the 3D model of the femur. The variably deformable portion 404 can be designed so that it can be deformed into three dimensions, including an X, Y, and Z direction, or any combination thereof. As described above, the less well-defined regions may be depicted less accurately in a 3D model due to lack of detail in the corresponding medical images (e.g., due to soft tissue), inaccuracies in the 3D model, and of such. Due to the flexible design of the variably deformable portion 404, the deformable portion 404 can adhere to the underlying, variable anatomical surfaces to create a fixed and stable fit and correct orientation for the surgical guiding device 400. The rigid portion 402 can, for example, adhere to areas of the femur that are more accurately modeled to obtain the majority of the appropriate positioning of the surgical guide device with adjustable surface 400, and the variably deformable portion 404 can adhere to the more variable, less well defined regions of the femur to achieve increased firmness and stability. In some embodiments, the variably deformable portion 404 may conform to the anterior region of the femur, as well as to the lower region of the femur comprising the medial articular node 108 and the lateral articular node 110 (as illustrated in Figures 1a-d). The variably deformable portion 404 can be designed to conform to a large area of the front and parts of the femur because there is more surface area in these areas that are less well defined and / or more variable.
The deformability and / or flexibility of the variably deformable portion 404 can vary at different points of the variably deformable portion 404 based on the variability of the underlying surface of the femur, as described above, such that it can conform to variable surfaces and / or soft tissue regions of the bone. The variably deformable portion 404 increases surface contact with the underlying surface of the femur, and thus can be used to increase the stability of the surgical guidance device with adjustable surface 400 without the risk of creating a tipping point. In some embodiments, different material thicknesses and / or patterns can be used to vary the flexibility of the variably deformable portion 404, as described above.
The variably deformable portion 404 can be designed based on a best estimate of the expected underlying anatomical surface. For example, each point on the variably deformable surface 404 can be designed based on medical image data, statistical shape models, documented anatomical averages of anatomical objects, and / or one or more accuracy maps.
An estimated variable accuracy anatomical model can be used as an initial design point for the variable deformable surface 404. Due to the inaccuracy and / or variability of the estimated underlying anatomical surface model, the variable deformable surface 404 can be designed with varying flexibility to conform to the anatomical surface. The use of estimated anatomical surfaces and accuracy maps has been described in more detail above with respect to Figures 2a-2d, and relates to a manner similar to the design of the rigid portion 402 and the variably deformable portion 404.
The surgical guiding device with adjustable surface 400 further comprises clamps 408. The clamps 408 comprise a group of deformable hinges 412. The deformable hinges 412 can be designed so that the clamps 408 can be deformed in only one dimension or direction, including an inward direction. The inward direction can be a combination of the X and Y directions. For example, the clamps 408 may be configured to attach to the medial articulation knot 108 and the lateral articulation knot 110 (as illustrated in FIG. 1). The deformable hinges 412 can only be deformed in an inward, one-dimensional direction in the direction of the corresponding joint bump and away from it. The firm adhesion of the clamps 408 to the joint nodules ensures that the surgical guiding device with adjustable surface 400 remains in a stable and fixed position during surgery. The deformable hinges 412 can be designed to be flexible, and not rigid, because the joint nodules include soft tissue that cannot be easily estimated in a femur model. Accordingly, the deformable hinges 412 allow the clamps 408 to adhere to the joint nodules even in the absence of a well-defined model of the joint nodules. The deformable hinges 412 may be designed based on the accuracy of the femur model to be less flexible than the variably deformable portion 404, but more flexible than the rigid portion 402. Additionally, the flexibility of the deformable hinges 412 using the techniques described above, one or more accuracy maps are used.
The surgical guiding device with adjustable surface 400 further comprises apertures 410 and 414. The apertures 410 and 414 may be aligned with areas of the underlying femoral surface corresponding to locations that should be accessible for surgery, such as locations where holes are to be drilled . For example, the apertures 410 can be used to guide a surgical device, such as a drill, to create holes 104 and 106 that are located on the anterior portion of the femur 100 (as illustrated in FIG. 1). Apertures 410 and 414 may additionally be designed to guide other surgical devices, such as: a drill, bur (orthopedic) saw, jigsaw, lateral drill, or any other cutting, milling, or drilling tool.
The apertures 410 and 414 are positioned such that a surgical device that has passed through one or more of the apertures 410 and 414 can reach the bone at the desired location. The apertures 410 and 414 can be positioned in any direction or angle to the bone as long as it provides access to a surgical device to reach the bone at the desired location. In some embodiments, the apertures 410 and 414 may protrude from the surface of the surgical guiding device with adjustable surface 400, as illustrated in Figures 4a and 4b. In other embodiments, the apertures 410 and 414 may be in the same plane as the surface of the surgical guide device with adjustable surface 400.
In some embodiments, the apertures 410 and 414 may include firmness stops to prevent a surgical device from being passed into the bone beyond a planned or predetermined depth. While the description herein may describe apertures 410 and 414 relative to specific locations on a femur, it will be apparent to one skilled in the art that the content of this disclosure relates in a manner similar to aperture locations that relate to patient-specific locations on different types of bones, which are determined using pre-operative planning and procedures as described above. FIG. 4b illustrates a rear view of the surgical guiding device with adjustable surface 400 of FIG. 4a. The rear view of FIG. 4b corresponds to the rear view of the femur 100 shown in FIG. 1b is illustrated. As illustrated in FIG. 4b, the variably deformable portion 404 can be coupled to the terminals 408 using deformable couplings 406. The deformable couplings 406 can be designed to be flexible in one or more dimensions. The deformable couplings 406 can, for example, be flexible in the X and Y dimensions. In some embodiments, the deformable couplings 406 may include a spring, a flexible clip, a flexible hinge, a flexible clip, or any other flexible coupling that allows movement or adjustability in one or more dimensions. One skilled in the art will appreciate that the malleable couplings can include any flexible coupler that allows movement or adjustability in one or more dimensions. In the embodiment shown in FIG. 4b, the deformable couplings 406 are designed to deform in an up and down direction (Y dimension) toward and away from the terminals 408, and in a left and right direction (X dimension) such that the surgical guiding device with adjustable surface 400 can adaptively fit a variable underlying surface of the femur. One or more accuracy maps can be used to design the flexibility of the deformable couplings 406 using the techniques described above.
The rigid portion 402, the variably deformable portion 404, and the deformable hinges 412 of the clamps 408 are designed to provide an adjustable surface with varying flexibility in different dimensions. The adjustable surface is based on the estimated accuracy of the underlying anatomical structure to create a fixed and stable fit for the surgical guide device with adjustable surface 400. FIG. 5a illustrates a view of another embodiment of a surgical guiding device with adjustable surface 500. In the embodiment shown in FIG. 5a, the surgical guiding device with adjustable surface 500 is designed to adhere firmly and stably to femur 512. The surgical guiding device with adjustable surface 500 includes a first rigid portion 502, which includes an integral aperture 510. The first rigid portion 502 is attached to rigid coupling 506. In this embodiment, rigid coupling 506, in contrast to the previously described deformable couplings, is designed such that it is rigid and movement in all dimensions is limited. In other embodiments, however, the rigid coupling 506 could be replaced instead of a deformable coupling. The rigid coupling 506 is further adhered to first variably deformable portion 504 and serves to rigidly connect the first variably deformable portion 504 to first rigid portion 502.
In some embodiments, rigid coupling 506 may be removable from rigid portion 502. For example, it was found that when the fit with intra-joint knotch notch 520 is less than optimal during an operation, rigid coupling may be released from rigid portion 502 by, for example, the shaft of rigid coupling 506 from sliding a complementary opening (not shown) into rigid portion 502. In other embodiments, the rigid coupling is integral with rigid portion 502.
Rather, the intra-joint knotty notch (such as intra-joint knotty notch 520) could be a difficult anatomical surface to use to increase surgical conductivity because the surface of the intra-joint knotty notch is often covered by soft tissue and the transition between cartilage and bone near this intra-joint knotty notch it is difficult to visualize and model using known techniques. Therefore, it was difficult to design patient-specific surfaces that were accurate enough to create a firm and stable adhesion between a portion of a surgical guide and the surface of the intra-joint knot. previous surgical guides could therefore lack the ability to limit all degrees of freedom and to create a fixed and stable fitting position of the guide. Particularly in cases where a bone (e.g., a femur) does not have any bony protruding part (e.g., osteophytes) to attach a surgical guide to it, flexion can be a problem because the round or spherical shape of many bone parts (e.g., the joint nodules of thigh bone) may allow rotational freedom of surgical guidance. An opposing force in the direction of rotation can help prevent rotation of a surgical guide. A variably deformable portion of a surgical guide that is designed to fit into an intra-joint knot notch can provide such an opposing force.
First variably deformable portion 504 is designed to fit intra-joint knotty notch 520 between lateral joint node 510 and medial joint node 508. In this embodiment, first variably deformable portion 504 includes three variably deformable portions 504a-504c that are designed to form an interface with or to form adhere to the intra-joint knob notch 520. The variably deformable portions 504a-504c may vary in their flexibility from their base to their end through, for example, varying thickness. In other embodiments, there may be more or less malleable portions that form first variably malleable portion 504. Additionally in this embodiment, first variably deformable portion 504 includes variably deformable portions 504a-504c that are patient-specific, that is, they are designed to more accurately form an interface with a particular intra-joint knotch notch 520 of the patient. In other embodiments, the deformable members may not be patient-specific. In such cases, the deformable members may be made so that they are more flexible or deformable in order to allow more variability in a particular intra-joint knot.
The flexible surface of first variably deformable portion 504 allows the adaptive surgical guiding device with adaptable surface 500 to conform intraoperatively to the actual anatomical structures by compressing first variably deformable portion 504 while it is placed in the intra-joint knotber notch 520. Because first variably deformable portion 504 is compressed during placement, the surgical guide device with adjustable surface 500 will be aligned with the desired position in a range defined by the allowed deformation. The distortion of the first variably deformable portion 504 when it enters the intra-joint knotch notch 520, therefore provides additional stability by limiting degrees of freedom in the directions of deformation. FIG. 5b illustrates another semi-transparent view of the surgical guiding device with adjustable surface 500. Again, rigid coupling 506 is shown as being connected between first rigid portion 502 and first variable-deformable portion 504. First variable-deformable portion 504 is shown as being attached to intra-joint knotty notch 520 (not shown). Apertures 510 and 514 are illustrated as being integral with first rigid portion 502. Second rigid portions 516a and 516b are attached to first rigid portion 502. Second rigid portions 516a and 516b are further attached to second variably deformable portions 518a and 518b. Second variably deformable parts 518a and 518b adhere to femur 512 to provide further strength and stability for surgical guiding apparatus with adjustable surface 500. In other embodiments, second variably deformable parts 518a and 518b may be rigid parts instead. For example, where the model of femur 512 is very accurate in the interface between femur 512 and elements 518a and 518b, a rigid portion may be used. Additionally, elements 518a and 518b, either rigid or malleable, can be patient-specific.
Also attached to first rigid portion 502 are deformable portions 522, which are springs in this embodiment. Deformable portions 522 (i.e., springs) are attached to third variably deformable portion 524. Deformable portions 522 allow the third variable portion 524 to move relative to femur 512 while surgical guiding device with adaptable surface 500 adheres to femur 512. Deformable parts 522 can have a uniform formability (for example, spring value) at the underlying position of each deformable part at the underlying position of each deformable part or can have varying deformation properties. Additionally, the deformable portions 522 may have variable deformation properties (i.e., spring values) based on the amount of deformation or compression of each individual deformable portion. For example, a certain deformable portion may be very docile (e.g., low spring value) after the first contact, but may increase in resistance (e.g., high spring value) as the level of deformation or compression increases. Third variably deformable portion 524 adheres to femur 512 to provide further firmness and stability for the surgical guide device with adjustable surface 500. As with the foregoing, third variably deformable portion 524 may be rigid and / or patient-specific. FIG. 6a illustrates a view of another embodiment of a surgical guiding device with adjustable surface 600. In the embodiment shown in FIG. 6a, the surgical guiding device with adjustable surface 600 is designed to adhere firmly and stably to a femur (not shown). Experts in this field will recognize that similar designs can be used to attach to different types of bones.
Surgical guiding apparatus with adjustable surface 600 includes a first rigid portion 602 (i.e., a body) and apertures 610a-b and 614a-b attached thereto, which can be used, for example, to guide surgical devices (e.g., a drill). Second rigid portions 616a and 616b are also attached to first rigid portion 602. Here, second rigid portions 616a and 616b take the form of rigid arms extending from first rigid portion 602. In other embodiments, however, second rigid parts 616a and 616b can be formed in different shapes. Second rigid parts 616a and 616b are further adhered to second variably deformable parts 618a and 618b. In some embodiments, second rigid portions 616a and 616b include stiffening flanges (not shown), which are connected between the second rigid portions 616a and 616b and the second variably deformable portions 618a and 618b. In such embodiments, the stiffening flanges stiffen the connection (i.e., make them less deformable) between the second rigid parts 616a and 616b and the associated second variably deformable parts 618a and 618b. It will be recognized by those skilled in the art that stiffening flanges can also be used to stiffen the connection between other aspects of adaptable surface surgical guidance devices.
Second variably deformable parts 618a and 618b attach to a bone to provide further firmness and stability for surgical guiding device with adjustable surface 600. In some embodiments, second variably deformable parts 618a and 618b can be designed to attach to front parts of a femur ( comprising the shaft of the femur) and are therefore designated with front support elements. In other embodiments, second variably deformable parts 618a and 618b may instead be rigid parts. Where the model of an underlying bone (e.g., a femur) is very accurate in the interface region between the bone and elements 618a and 618b, for example, a rigid portion may be used instead.
Additionally, elements 618a and 618b, either rigid or malleable, can be patient-specific, i.e., shaped to conform to one of the patient-specific anatomical features.
Second rigid parts 616a and 616b are connected by a deformable coupling 606. Deformable coupling 606 can be a spring, a flexible clip, a flexible hinge, a flexible clamp, or any other flexible coupling that allows movement or adjustability in one or more directions, include. In this embodiment, the deformable coupling becomes a flexible buckle that allows the second variably deformable portions 618a and 618b to move relative to each other while surgical guide device with adjustable surface 600 is attached to a bone surface. Deformable coupling 606, however, limits the overall movement of second variably deformable portions 618a and 618b so that, for example, the variably deformable portions are not distorted too significantly, which may cause incorrect placement of surgical guiding device with adjustable surface 600.
As shown in FIG. 6b, first rigid portion 602 are also deformable portions 622, which in this embodiment are springs. Deformable portions 622 are attached to third first deformable portions 624a-624d. In this embodiment, first variably deformable portions 624a-624d can also be referred to as distal support elements. Deformable portions 622 allow the third variable portions 624a-624d to move relative to a bone (e.g., a femur) while surgical guide device with adjustable surface 600 is adhered to the bone. As above, deformable portions 622 may have uniform deformability (e.g., spring value or compression values) or may have varying deformation properties based on the reliability of the 3D model at the underlying position of each deformable portion. Additionally, the deformable portions 622 may have variable deformation properties based on the amount of deformation or compression of each individual deformable portion. For example, a certain deformable portion can be very compliant (e.g., compression value) after a first contact, but its resistance can increase (e.g., high compression value) if the level of deformation or compression is higher.
Deformable portions 622 are attached to first variably deformable portions 624a-624d, which are designed to attach to a bone (e.g., a femur) to provide further rigidity and stability for surgical guiding apparatus with adaptable surface 600. As before, first variable deformable parts 624a-624d are optionally rigid and / or patient-specific. First variably deformable portions 624a-624d may be spaced apart (as shown) to account for patient-specific anatomical features on the underlying bone, such as soft tissues or other bony masses. The determined distance and arrangement of first variably deformable portions 624a-624d can be pre-functionally designed based on a 3D or other model of the underlying bone that they are intended to attach to it. In other embodiments, first variably deformable portions 624a-624d may instead be lower in number, or even a single surface. In this embodiment, the broad base of first rigid portion 602 allows many arrangements of the variably deformable parts and their attached variably deformable parts. FIG. 7a illustrates a view of another embodiment of a surgical guiding device with adjustable surface 700. In the embodiment shown in FIG. 7a, the surgical guiding device with adjustable surface 700 is designed to adhere firmly and stably to a tibia (not shown). Experts in this field will recognize that similar designs can be used to attach to different types of bones.
Surgical guiding apparatus with adjustable surface 700 includes a first rigid portion 702 (i.e., a body) and apertures 710 attached thereto, which can be used, for example, to guide surgical devices (e.g., a drill). Second rigid portions 716a and 716b are also attached to first rigid portion 702. Here, second rigid portions 716a and 716b form an integral whole with rigid portion 702. In other embodiments, however, second rigid portions 716a and 716b can be formed in different shapes (e.g., arms as described above). Second rigid parts 716a and 716b are further adhered to first variably deformable parts 708a and 708b.
First variably deformable parts 708a and 708b include deformable hinges 712. Together, first variably deformable parts 708a and 708b and deformable hinges 712 attach to a bone to provide further rigidity and stability for surgical guiding apparatus with adjustable surface 700. In some embodiments, deformable are hinges thinner than their associated first variably deformable parts. In such embodiments, the purpose of the deformable hinges is not so much to provide stability for the surgical guide device with adjustable surface 700, but to provide visual feedback to a user, such as a doctor, who is attaching the guide.
In some embodiments, first variably deformable portions 708a and 708b may be designed to adhere to proximal portions of a tibia (including the tibial plateaus) and may therefore be referred to as proximal support elements. In such embodiments, first variably deformable portions 708a and 708b can have separate shapes that reflect the separated shapes of the bone portions that they are intended to adhere to. Alternatively, first variably deformable portions 708a and 708b may have standard shapes that can be interchangeable (i.e., attached to, or separate from, second rigid portions 716a and 716b). In such cases, a user can select an appropriate form of first variably deformable portion intraoperatively. In other embodiments, first variably deformable parts 708a and 708b may instead be rigid parts. Where the model of an underlying bone (e.g., a tibia) is very accurate in the interface region between the bone and elements 708a and 708b, for example, a rigid portion may be used instead. Additionally, elements 708a and 708b, either rigid or deformable, can be patient-specific, that is, have a shape such that they conform to one of the patient-specific anatomical features.
A second variably deformable portion 718 is also connected to rigid portion 702 of surgical guiding device with adjustable surface 700. In this embodiment, the second variably deformable portion is designed to attach to a front portion of a tibia and can therefore be referred to as a front support element . In other embodiments, second variably deformable portion 718 may instead be rigid. Additionally, variable deformable portion 718, either rigid or deformable, can be patient-specific.
As shown in FIG. 7b, a third rigid portion 720 is also attached to first rigid portion 702. In this embodiment, the third rigid portion 720 is designed to adhere to a front portion of a tibia and may be referred to as a front lip. In other embodiments, third rigid portion 720 may be deformable instead. Additionally, the third rigid portion 720, either rigid or malleable, may be patient-specific. FIG. 8a illustrates a view of another embodiment of a surgical guide device with adjustable surface 800. The surgical guide device with adjustable surface 800 shown in FIG. 8 is similar to the embodiment described with respect to FIGS. 6a-6b, so that similar features will not be described again. In the embodiment shown in FIG. 8a, the surgical guiding device with adaptable surface 800 includes an associated slot 860.
Associated slot 860 can be used to attach various devices to surgical guiding device with adjustable surface 800. These attachable devices can be patient-specific or standard ready-made items.
For example, associated slot 860 may be configured to receive a verification element such as guide for resection 862 shown in FIG. 8b is displayed. In some embodiments, the guide for resection 862 may be referred to as an "angel wing" as known to those skilled in the art. The guide for resection can be used prior to performing a resection or osteotomy to verify the location of the cut surface with respect to an anatomical object, such as a bone. For example, in a total knee arthroplasty, a guide for resection such as guide 862 may be used for a front femoral cut to prevent indentation.
Embodiment guidance embodiments can take many forms such as dictated by patient anatomy, the surgical plan, and other considerations known to those skilled in the art. In addition, using accessory slot 860, other types of verification elements, such as those known to those skilled in the art, can be adhered to surgical guiding apparatus with adaptable surface 800.
As discussed above, achieving greater stability of surgical guiding devices can be facilitated by increasing the number and / or size of the support surfaces adhered to an anatomical object (such as a bone). In previously described embodiments, a combination of rigid and deformable members serves to place support surfaces (including patient-specific surfaces) in contact with the anatomical object. Unfortunately, it is not always possible to achieve sufficient firmness and stability of a surgical guide without removing soft tissue (s) (for example, cartilage) from the anatomical object. But the removal of additional soft tissue is generally undesirable.
Accordingly, in some embodiments, one or more soft tissue penetrating pins may be used to penetrate soft tissue (such as cartilage, tendons, etc.) that is attached to an anatomical object (such as a bone) to increase the stability of surgical guidance. . Additionally, such soft tissue penetrating pins can be used to verify the correctness of the fit of a surgical guide. In order to avoid contamination and infection, the soft tissue penetrating pin may be designed as a feature of a surgical guide such that the pin penetrates only soft tissue in an area of an incision, but not into the skin outside the surgical site (e.g., the dermis and epidermis).
In some embodiments, the soft tissue penetrating pin may be an integral part of a surgical guide. In such embodiments, the design of the surgical guide should be such that, after normal adhesion of the surgical guide to an anatomical object (such as a bone), the pin enters the soft tissue in the correct location and does not penetrate into the skin. Once sutured, the soft tissue penetrating pin acts as a support surface that adheres to the anatomical object through intervening soft tissue, which increases the firmness and stability of the attached surgical guide.
In other embodiments, the soft tissue penetrating pin may be an optional, i.e., removable, accessory to the surgical guide. If it is not possible to design the surgical guide such that after normal placement of the guide, the path of the soft tissue penetrating pin through the soft tissue leads the pin to the correct position, the surgical guide may comprise, for example, a pin guide opening. In such embodiments, after placement of the surgical guide, the soft tissue penetrating pin can be inserted with guide through the opening, penetrating the soft tissue until it touches an anatomical object (such as a bone). In such embodiments, the surgical guide and soft tissue penetrating pin can include markings so that the soft tissue penetrating pin can act as a depth gauge. When the soft tissue penetrating pin is used in this manner, it functions as a method of verifying the correctness of the fit of the surgical guide to the anatomical object.
In further embodiments, the soft tissue penetrating pin can be an integral part of a suture component, including "ready-made" components, which can be connected to the surgical guide either before or after placing the guide on the bone. embodiment of a surgical guiding device with adjustable surface 900 comprising a soft tissue penetrating pin 934. The soft tissue penetrating pin 934 is a type of stability element, i.e. an element designed to stabilize the adhesion of a surgical guiding device with adjustable surface 900 to an underlying anatomical object The surgical guiding device with adjustable surface 900 illustrated in Figure 9 is similar to the embodiment described with respect to Figures 6a and 6b so that similar features will no longer be described.
In FIG. 9, a dashed line 950 indicates a line of incision, with the skin separated to reveal an operating area. The area between dashed line 950 and dashed line 952 represents a soft tissue region where soft tissue (not shown) over thigh 912. Similar to the embodiments described with reference to Figs. 6a and 6b, various stability elements of adaptable surface surgical guide device 900, such as deformable portions 918 and 924, adhere to thigh bone 912 surfaces that often do not include soft tissue. But in order to provide additional stability elements outside these surfaces, additional soft tissue must be removed using the deformable elements as described above. Instead of removing additional soft tissue, a soft tissue penetrating pin 934 can be used to provide additional adhesion to femur 912, providing additional strength and stability for surgical guiding device with adjustable surface 900 when appropriate.
In the embodiment shown in FIG. 9, surgical guidance device with adjustable surface 900 includes third rigid portion 930, which is fixed to rigid support member 928. Rigid support member 928 is integral on each side with apertures 914a and 914b and with first rigid portion 902. In this embodiment, third rigid portion 930 permanently fixed and therefore integral with surgical guiding device with adjustable surface 900. In other embodiments, however, third rigid portion 930 may be a part of a suture of removable soft tissue penetrating pin 940. Additionally, the third rigid portion 930 can be adhered to other aspects of surgical guiding device with adjustable surface 900.
The third rigid section 930 includes section 932. Section 932 may include an aperture (not shown) through which soft tissue penetrating pin 934 is inserted. In such embodiments, part 932 may provide lateral support for the soft tissue penetrating pin 934. In embodiments where soft tissue penetrating pin 934 is not permanently fixed to third rigid portion 934, but is movable by an aperture in third rigid portion 934, and where part 932 has a recess 936 has where soft tissue penetrating pin 934 can be seen, the movement of soft tissue penetrating pin 934 can act as a depth or fit indicator. For example, as surgical guide device with adaptable surface 900 adheres to femur 912, soft tissue penetrating pin 934 may move upwardly into recess 936 in portion 932 until it contacts the top of recess 936. At that time, it can be determined whether the surgical guiding device with adjustable surface 900 is in the correct position. In other embodiments, soft tissue penetrating pin 934 may be permanently or releasably fixed to third rigid member 930 without member 932.
Part 932 can also be used as an appendix to aid in pressing soft tissue penetrating pin 934 through soft tissue (not shown). By providing a contact surface that is higher than rigid portion 930, portion 932 can facilitate adhesion of surgical guiding device with adjustable surface 900 by providing a surface above the level of the anatomical object.
In some embodiments, soft tissue penetrating pin 934 may be movable and biased by a deformable member such as a spring. In such cases, portion 932 may enclose a deformable, biased portion (such as a spring that is not shown) that is adhered to the tip of soft tissue penetrating pin 934. In such embodiments, soft tissue penetrating pin 934 may be biased such that pin 934 penetrates soft tissue (such as cartilage) but not harder anatomical objects (such as bones) when surgical guiding device with adaptable surface 900 is fitted appropriately. The deformable biased portion (not shown) in portion 932 may therefore allow some inaccuracy in designing an adaptable surface surgical guide device 900 because the soft tissue penetrating pin 934 can still adhere to an underlying anatomical object even if the design of surgical guiding device with adaptable surface 900 is not exact. FIG. 10 illustrates another embodiment of a surgical guiding device with adjustable surface 1000 including a soft tissue penetrating pin 1034. As in FIG. 8, the various support surfaces of surgical guide device with adaptable surface 1000 adhere to surfaces of femur 1012 that often do not include soft tissue. And again, dashed line 1050 indicates an incision line where the skin is separated to reveal an operating area, and the area between dashed line 1050 and dashed line 1052 represents an area where soft tissue (not shown) lies over thigh bone 1012.
In the embodiment shown in FIG. 10, surgical surface guiding device with adjustable surface 1000 includes third rigid portion 1030 and soft tissue penetrating pin 1034, which together comprise the soft tissue penetrating pin suture 1040. In this embodiment, the soft tissue penetrating pin suture 1040 is releasably fixed to an adaptable surface 1000 surgical guide device. Also in this embodiment, soft tissue permeable pin 1034 is integrally formed with third rigid member 1030 such that soft tissue permeable pin suture 1040 can be produced as a single piece.
Soft tissue penetrating pin suture 1040 can be fixed through a slot in rigid support member 1028 (not shown) to surgical guiding apparatus with adaptable surface 1000. However, in other embodiments, soft tissue penetrating pin suture 1040 can be fixed to other aspects of an adaptable surface 1000 surgical guiding device. In this way, one or more soft tissue permeable pin suture (s) (such as 1040) can be tested for fit on an anatomical object (such as thigh 1012) during an operation, and the best fit can be chosen accordingly. In this way, ready-to-use or conventional components can be made such that they operate with surgical guide device with adaptable surface 1000.
The various parts of the surgical surface guided surgical devices described above have been designed and produced to include varying deformation properties and flexibilities in order to create an adaptable surface for many bone types and locations. In some embodiments, one or more rigid portions are configured to overlap with at least a portion of one or more variably deformable portions. For example, a variably deformable portion may conform to a larger area of the anatomical surface than that to which a rigid portion may adhere because there is more surface area in these areas that is less well defined and / or variable and not for designing the rigid portion for adhesion thereto can be used.
The combination of rigid parts and variably deformable parts described above provides for a firm and stable adhesion of the surgical guide devices with adaptable surface to the underlying anatomy, even in areas that are highly variable and / or that are not well defined in a 3D model . Accordingly, even with the use of inexact displays and models of the underlying anatomy and despite the presence of highly variable anatomical surfaces, a surgical guiding device with adaptable surface can be designed.
In some embodiments of the adaptable surface surgical guide devices described above, the variably deformable portion or portions include a plurality of holes with which the underlying anatomical surface is exposed. In some embodiments, the plurality of holes is designed to add more formability or flexibility to the variably formable portion.
In some embodiments, one or more rigid portions are configured to overlap with at least a portion of a variably deformable portion. For example, the variably deformable portion can conform to a larger area of the anatomical surface than that to which the rigid portion can adhere because there is more surface area in these areas that is less well defined and / or variable and cannot be used to design the rigid portion for adhesion thereto.
In some embodiments, a variable deformable portion is coupled to a rigid portion using at least one deformable coupling. In some embodiments, the at least one deformable coupling comprises one or more springs. In other embodiments, the malleable couplings may comprise any of the malleable couplings described above.
In some embodiments, the design of the adjustable surface surgical guiding device further comprises at least one of a clip, a hinge, a clip, and a spring coupled to at least one of a variably deformable portion and a rigid portion. The surgical guiding device may, for example, comprise a clamp, such as clamps 408. The clamp may include one or more group of deformable hinges, such as deformable hinges 412, which are designed to be deformed in a particular direction.
In some embodiments, the underlying anatomical surface includes a femur, such as the femur 212. In these embodiments, a rigid portion is configured to attach to an anterior portion of the femur and one or more articular nodules of the femur, and a variably deformable portion is configured to conform to the shape of the anterior portion and the one or more joint bumps of the femur. In other embodiments, the underlying anatomical surface comprises a tibia. In these embodiments, a rigid portion can be configured to attach to a proximal portion of the tibia, such as one or more tibial plateaus, and a front portion of the tibia.
In general, the flexible or deformable portions of an adjustable surface surgical guiding device, such as those described above, are designed to adhere to areas of a bone where the bone model is less accurate. As such, the flexible or deformable portions of the adaptable surface surgical guiding device provide a way to obtain the guidance in an approximate position. On the other hand, the rigid portions of an adaptable surface surgical guidance device are designed to adhere to areas of a bone where the bone model is more accurate. The rigid members, therefore, provide a hard stop for an end position of an adjustable surface surgical device while it is being placed.
In some embodiments, adaptive surface surgical guiding devices may include only deformable portions with varying flexibility. For example, a fully deformable or flexible guide can be designed, for example, for an anatomical surface that has not been modeled or shown to be accurate enough to use a rigid portion for adhesion. FIG. 11 illustrates a method 1100 of manufacturing an adaptable surface surgical guiding device. The method 1100 can be implemented to produce an adaptive surface surgical guiding device such as, for example, adaptable surface surgical guiding devices 200, 300, 400, 500, 600, 700, 800, 900, and / or 1000. Although the method 1100 can be described below. be described with respect to elements of the surgical guide devices with adjustable surface 200 and / or 400, those skilled in the art will recognize that other components may also be used to implement one or more of the blocks described herein.
At block 1102, the method starts with designing an adaptive surface surgical guidance device to create a adaptable surface surgical guidance device. The design of the adaptable surface surgical guide device includes one or more rigid portions configured to adhere to a first region of an underlying anatomical surface. For example, one or more rigid parts may comprise the rigid parts with reference to Figures 2-10. The design of the adaptable surface surgical guiding device further comprises one or more variably deformable portions coupled to the one or more rigid portions and configured to conform to a shape of a second region of the underlying anatomical surface to provide a fixed and stable adhesion of the surgical guiding device with adaptable surface to the underlying anatomical surface. The one or more variably deformable parts may, for example, comprise any of the variably deformable parts described with reference to Figs. 2-10.
In some embodiments, the method 1100 may further include the step of designing an associated slot for the adaptable surface surgical guidance device.
In some embodiments, the method 1100 may further include the step of designing a soft tissue penetrating element configured to penetrate soft tissue that overlies an area of an underlying anatomical surface.
In some embodiments, the method 1100 may further include the step of designing the variably deformable portion based on an amount of variability of the underlying anatomical surface such that it varies at different points of the variably deformable portion or is flexible. For example, the deformability of the variably deformable portion may be designed to increase between the different points when the variability of the underlying anatomical surface for which the different points are configured to attach is higher. For example, a large area of the anatomical surface may include soft tissue that is not reflected in a medical image, such as an X-ray or a CT scan. The same or a different area of the anatomical surface can comprise a highly variable surface. The points on the variably deformable portion that are designed to adhere to that area of the anatomical surface can be highly deformable or flexible so that those points can conform to the variable surface and / or soft tissue area of the anatomical surface. As described in more detail above, different material thicknesses and / or patterns can be used to vary the flexibility of the variably deformable portion.
In some embodiments, the method 1100 may further include the step of determining a range of variability of the underlying anatomical surface, and applying a variability map to the variably deformable portion based on the determined range of variability. The variability map specifies a deformability metric for a plurality of points of the variably deformable portion. for example As described above, the deformability metric for a given point on the variability map corresponds to the variability of a corresponding point on the surface of the anatomical surface. The variability map can then be applied to the variably deformable portion so that each point of the variably deformable portion is designed as being deformable relative to the deformability metric of a corresponding point on the variability map. Based on the application of the variability map, points of the variably deformable portion, which are designed to adhere to very inaccurately modeled and / or more variable areas of the underlying anatomical surface, can be highly deformable so that the variably deformable portion is independent of the variability of that surface will conform to the anatomical surface.
At block 1104, the method 1100 ends with the production of the adjustable surface surgical guide device based on the design of the adjustable surface surgical guide device. As described above, the surgical guiding device may be designed in accordance with patient-specific characteristics of a patient's anatomy. The adaptable surface surgical guiding device can be produced using 3D printing techniques, which are described in more detail below.
In some embodiments, the surgical guiding devices 200, 300, 400, 500, 600, 700, 800, 900, and / or 1000 can be produced as a single, continuous structure (e.g., a single die) that includes all components of the adaptable surface guiding device comprising: the rigid portion (s), the variably deformable portion (s), the deformable coupling (s), the clamp (s) (if any), and / or the aperture (s) (if present). In some embodiments, each component of the surgical guide devices with adjustable surface 200, 300, 400, 500, 600, 700, 800, 900, and / or 1000 can be produced as a separate structure that integrates with the other components to create the surgical guiding devices with adjustable surface.
In some embodiments, the surgical guide devices with adjustable surface 200, 300, 400, 500, 600, 700, 800, 900, and / or 1000 can be partially or fully produced by 3D printing. 3D printing or rapid prototyping and production (Rapid Prototyping and Manufacturing; RP & M) can be defined as a group of techniques used to produce an object using, for example, a 3D computer assisted design (CAD) of the object. Nowadays, a variety of rapid prototyping techniques are available, including stereolithography (SLA), selective laser sintering (SLS), Fused Depositionition Modeling (FDM), foil-based techniques, and the like.
A general feature of 3D printing and RP & M techniques is that objects are usually built up layer by layer. For example, stereolithography uses a vessel of liquid photopolymer "resin" to layer an object. On each layer, an electromagnetic beam traverses paths with a specific pattern on the surface of the liquid resin, which paths are defined by the two-dimensional cross-sections of the object to be formed. The electromagnetic beam can be delivered as one or more laser beams that are controlled by a computer. Exposure of the resin to the electromagnetic beam heart, or, hardens the pattern traversed by the electromagnetic beam, and causes the layer below to adhere to it. After a resin coating has been polymerized, the platform drops with a single layer thickness and a pattern is traversed in the subsequent layer, the new layer with the traversed pattern adhering to the previous layer. By repeating this process, a complete 3D object can be formed.
Selective laser sintering (SLS) is another 3D printing technique. SLS uses a high-power laser or other focused heat source for sintering or welding small particles of plastics, metal, or ceramic powders in a mass that represents the 3D object to be formed. SLS can be used to produce devices that require elastic or flexible materials. Materials used in the SLS process can include polyamide, polypropylene, and / or thermoplastic polyurethane. The different materials can be selected for use in the SLS process based on the particular article or production method. For example, polypropylene can be used in large-scale production of an article.
Fused Depisition Modeling (FDM) provides yet another 3D printing approach. FDM and other related techniques use a temporary transition from a solid material to a liquid stage, usually due to heating. The material is driven through an extrusion nozzle in a controlled manner, and the material is then deposited at a specified location. Details of a suitable FDM process are explained in U.S. Pat. Patent No. 5,141,680, the entire disclosure of which is hereby incorporated by reference.
Foil-based techniques can also be used to support 3D printing. Foil-based techniques relate to the use of glue or photopolymerization for joining resin coatings together. The desired article is then cut from these coatings, or the article is polymerized from these coatings.
Usually 3D printing and RP & M techniques start with a digital representation of the 3D object to be formed. In general, the digital display is divided into a series of cross-sectional layers which are covered to form the object as a whole. The information about the cross-sectional layers of the 3D object is stored as cross-sectional data. The RP & M system uses this cross-sectional data for the purpose of building the object on a layer-by-layer basis. The cross-sectional data used by the RP & M system can be generated using a computer system. The computer system may include software such as computer assisted design and production of (CAD / CAM) to contribute to this process. Any suitable 3D printing technique known in the art can be used to convert the bone medical image information into a model, mold, or template that at least partially exhibits the positive or negative shape of at least a portion of the bone . using medical image data, for example, a virtual 3D model can be generated, as described above, which can be used to generate an object using 3D printing techniques.
The use of 3D printing avoids the need to merge different parts. 3D printing also allows the integration of the various patient-specific components (e.g., the rigid portion, the variably deformable portion, the one or more clamps, the deformable couplings, the apertures, and the like), which further improves the accuracy of the surgical guiding devices with adjustable surface. The patient-specific components of the surgical guiding devices may be designed on the basis of patient-specific surfaces of a particular bone of a patient, for example by using the pre-operative procedures described above. The patient-specific components of the surgical surface-guided surgical devices can be made by generating parts that are complementary to the patient-specific parts of the bone.
The surgical guiding devices with adaptable surface (or parts thereof) described above can be produced using different materials. In some embodiments, only materials that are biologically compatible (e.g., USP class VI compatible) are used with the human body. In some embodiments, an adaptable surface surgical guiding device may be formed from a heat-tolerable material so that high-temperature resistance to sterilization becomes possible. In some embodiments, the SLS surgical guiding device, if used as an RP & M technique, may be produced 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. FIG. 12 illustrates an example of a system 1200 for designing and producing 3D devices and / or products. The system 1200 can be configured to support the techniques described herein. The system 1200 can be configured, for example, to design and generate an adaptable surface surgical guidance device, such as each one or more described above. In some embodiments, the system 1200 may include one or more computers 1202a-1202d. The computers 1202a-1202d can take various forms, such as, for example, any workstation, server, or other computing device capable of processing information. The computers 1202a-1202d can be connected by a computer network 1205. The computer network 1205 can be the internet, a network of a local area, a network of an extended area, or some other type of networks. The computers can communicate via the computer network 1205 via any suitable communication technology or protocol. The computers 1202a-1202d can share data by transmitting and receiving information, such as software, digital displays of 3D objects, commands and / or instructions for operating a 3D printing device, and the like.
The system 1200 may further comprise one or more 3D printing devices 1206a and 1206b. These 3D printing devices can take the form of 3D printers or any other production device known in the art. In the example shown in FIG. 12, the 3D printing device 1206a is connected to the computer 1202a. The 3D printing device 1206a is also connected to computers 1202a-1202c via the network 1205 which connects computers 1202a-1202d to each other. 3D printing device 1206b is also connected to the computers 1202a-1202d via the network 1205. A person skilled in the art will quickly recognize that a 3D printing device such as devices 1206a and 1206b can be connected directly to a computer 1202, can be connected to a computer 1202 via a network 1205, and / or via another computer 1202 and the network 1205 can be connected to a computer 1202.
Although in FIG. 12 describes a specific computer and network configuration, one skilled in the art will also recognize that the 3D printing techniques described herein using any computer configuration that controls and / or assists the 3D printing device 1206 without the need for a computer network be implemented. FIG. 13 illustrates a more detailed view of computer 1202a illustrated in FIG. 9. The computer 1202a includes a processor 1310. The processor 1310 is in data communication with various computer components. These components may include a memory 1320, an input device 1330, and an output device 1340. In certain embodiments, the processor may also communicate with a network interface card 1360. Although described separately, it is to be understood that functional blocks described with respect to computer 1202a need not be separate structural elements. The processor 1310 and network interface card 1360 can be embodied, for example, in a single chip or circuit board.
The processor 1310 may be a general purpose processor, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field-programmable gate array (FPGA) or other programmable electronic device, a separate port or electronic transistor, separate hardware components, or any suitable combination thereof designed to perform the functions described herein. A processor may also be implemented as a combination of computing devices, for example, a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration.
The processor 1310 may, via one or more buses, be coupled to read information from or write information to memory 1320. The processor may additionally, or additionally, include memory such as processor registers. The memory 1320 may include a processor cache comprising a multi-level hierarchical cache with different levels having different capacities and access speeds. The memory 1320 may further comprise a random access memory (RAM), other temporary storage devices, or non-temporary storage devices. The storage can include hard disks, optical disks such as compact discs (CDs) or digital video discs (DVDs), flash memory, floppy disks, magnetic tape, and zip disks.
The processor 1310 may also be coupled to an input device 1330 and an output device 1340 for receiving input from, and providing output to, a user of the computer 1202a, respectively. Suitable input devices include, but are not limited to, a keyboard, a roller ball, buttons, keys, a switch, a pointing device, a mouse, a joystick, a remote control, an infrared detector, a voice recognition system, a barcode reader, a scanner, a video camera ( possibly coupled to video processing software for, for example, detecting hand gestures or facial expressions), a motion detector, a microphone (possibly coupled to audio processing software for, for example, detecting voice commands), or other device capable of transferring information from a user to a computer. The input device may also take the form of a touch screen associated with the display, in which case a user responds to calls on the display by touching the screen. The user can enter the textual information by means of the input device, such as the keyboard or the touch screen. Suitable output devices include, but are not limited to, visual output devices, including display and printers, audio output devices, including speakers, headphones, earphones, and alarms, 3D printing devices, and haptic output devices.
The processor 1310 may further be coupled to a network interface card 1360. The network interface card 1360 prepares data generated by the processor 1310 for transmission via a network according to one or more data transfer protocols. The network interface card 1360 may also be configured to decode data received over the network. In some embodiments, the network interface card 1360 may include a sender, receiver, or both. Depending on the specific embodiment, the sender and receiver can be a single integrated component, or they can be two separate components. The network interface card 1360 may be embodied as a general purpose processor, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA) or other programmable electronic device, individual port or electronic transistor, individual hardware components, or any suitable combination thereof designed to perform the functions described herein.
By using the devices described in connection with FIGS. 12 and 13, a D-printing process can be used to produce a 3D product or device. FIG. 14 illustrates a general process 1400 for producing an adaptable surface surgical guiding device, such as that described above in connection with FIGS. 2-7.
The process begins at step 1405, where a digital representation of the device to be produced is designed using a computer, such as computer 1202a. In some embodiments, a 2D representation of the device can be used to create a 3D model of the device. Alternatively, 3D data can be entered into the computer 1202a for assistance in designing the digital display of the 3D device. The process continues until step 1410, where information is sent from the computer 1202a to a 3D printing device, such as 3D printing device 1206. After this, at step 1415, the 3D printing device 1206 begins the production of the 3D device by performing a 3D printing process using suitable materials. Suitable materials include, but are not limited to, polypropylene, thermoplastic polyurethane, polyurethane, acrylonitrile butadiene styrene (ABS), polycarbonate (PC), PC-ABS, polyamide, polyamide with additives such as glass or metal particles, methyl methacrylate-acrylonitrile-butadiene-styrene- copolymer, resorbable materials such as polymer-ceramic composites, and other similar suitable materials. In some embodiments, commercially available materials can be used. These materials may include: DSM Somos® series of materials 7100, 8100, 9100, 9420, 10100, 11100, 12110, 14120 and 15100 from DSM Somos; ABSplus-P430, ABSi, ABS-ESD7, ABS-M30, ABS-M30i, PC-ABS, PC-ISO, PC, ULTEM 9085, PPSF and PPSU materials from Stratasys; Accura plastic, DuraForm, CastForm, Laserform and VisiJet line of materials from 3-Systems; aluminum, cobalt chrome and stainless steel materials; Maranging steel; nickel alloy; titanium; the PA line of materials, PrimeCast and PrimePart materials and Alumide and CarbonMide from EOS GmbH. Using the appropriate materials, the 3D printing device then completes the process at step 1420, where the 3D device is generated.
By using a process such as process 1400 that is associated with FIG. 14, an adaptable surface surgical guiding device can be produced using 3D printing techniques. By using a D-printing method such as process 1400, it becomes possible that a surgical surface-guided surgical device with rigid parts and variably deformable parts can be produced. Various specific 3D printing techniques can be used to produce a surgical guiding device with adjustable surface. As explained above, these techniques selectively include laser sintering, stereolithography, fused deposition modeling, or a film-based technique. By using these and other 3D printing techniques, the entire surgical guiding device can be produced without the requirements of separate production and assembly of several different parts.
The invention disclosed herein can be implemented as a method, device, or article produced using standard programming or manipulation techniques to produce software, hard software, hardware, or any combination thereof. The term "produced article" as used herein refers to codes or logic implemented in hardware or permanent computer readable medium such as optical storage devices, and temporary or non-temporary memory devices or temporary computer readable medium such as signals, support waves, etc. Such hardware may include, but is not limited to, field programmable gate arrays (FPGAs), application-specific integrated circuits (ASICs), complex programmable logic devices (CPLDs), programmable logic matrices (PLAs), microprocessors, or other similar processing devices.
It will be appreciated by those skilled in the art that numerous variations and / or modifications can be made to the invention without departing from the spirit or scope of the invention as broadly described. The embodiments described above are, therefore, to be considered in all respects as illustrative and not restrictive.

权利要求:
Claims (14)
[1]
CONCLUSIONS
A surgical guiding apparatus comprising: one or more rigid portions configured to adhere to a first region of an underlying anatomical surface; a variably deformable portion coupled to the one or more rigid portions, the variably deformable portion being configured to conform to a shape of a second region of the underlying anatomical surface; and a soft tissue penetrating element configured to penetrate and adhere soft tissue over a third area of the underlying anatomical surface.
[2]
The surgical guiding device of claim 1, wherein the soft tissue penetrating element comprises a pin.
[3]
The surgical guiding device of claim 2, wherein the soft tissue invading element is connected to a deformable member.
[4]
The surgical guiding device of claim 3, wherein the deformable member is a spring.
[5]
The surgical guiding device of claim 1, further comprising at least one of a clip, a hinge, a clip, and a spring coupled to at least one of the variably deformable portion and the one or more rigid portions.
[6]
The surgical guiding device of claim 1, wherein the one or more rigid portions are configured to overlap with at least a portion of the variably deformable portion.
[7]
The surgical guiding device of claim 6, wherein the variably deformable portion is coupled to the one or more rigid portions using at least one deformable coupling.
[8]
The surgical guiding device according to claim 7, wherein the at least one deformable coupling comprises one or more springs.
[9]
The surgical guiding device of claim 2, wherein the soft tissue comprises at least one of cartilage, muscles, tendons, or ligaments.
[10]
The surgical guiding device of claim 9, wherein the soft tissue is not dermis or epidermis.
[11]
The surgical guiding device of claim 1, wherein: the underlying anatomical surface comprises a femur; the one or more rigid portions are configured to attach to a front portion and one or more thigh bone joint nodules; and the variably deformable portion is configured to conform to a shape of the anterior portion and the one or more joint bumps of the femur.
[12]
The surgical guiding device of claim 1, further comprising an associated slot.
[13]
The surgical guiding device of claim 12, further comprising a removable guide for resection, wherein the removable guide for resection is configured to attach to the associated slot.
[14]
The surgical guiding device of claim 13, wherein the removable guide for resection is an angel wing.

类似技术:

---

公开号 | 公开日 | 专利标题

---

BE1022556B1|2016-06-02|Surgical guiding devices with adjustable surface comprising stability and / or verification elements

---

US10231745B2|2019-03-19|Adaptive surface surgical guiding apparatus and systems and methods of manufacturing adaptive surface surgical guiding apparatus

---

US20190038361A1|2019-02-07|Method Of Designing Orthopedic Implants Using In Vivo Data

---

BE1018900A5|2011-10-04|ADJUSTABLE THERAPEUTIC, DIAGNOSTIC, OR SURGICAL GUIDE.

---

US20150190145A1|2015-07-09|Customized Patient-Specific Bone Cutting Blocks

---

JP5570826B2|2014-08-13|Customized patient-specific patella resection guide

---

US20180303491A1|2018-10-25|Two-part surgical guide

---

US20140200902A1|2014-07-17|Customized patient-specific bone cutting blocks

---

US9339281B2|2016-05-17|Surgical guiding tools and systems and methods of manufacturing surgical guiding tools

---

WO2021011280A1|2021-01-21|Surgical registration tools, systems, and methods of use in computer-assisted surgery

---

AU2014202549B2|2015-11-05|Customized patient-specific patella resectioning guide

---

AU2020315554A1|2022-03-03|Surgical registration tools, systems, and methods of use in computer-assisted surgery

同族专利:

---

公开号 | 公开日

---

WO2015121400A1|2015-08-20|

---

BE1022556A1|2016-06-02|

---

EP3104789A1|2016-12-21|

---

GB201402563D0|2014-04-02|

---

US20160367264A1|2016-12-22|

---

EP3104789B1|2018-12-05|

---

US10123807B2|2018-11-13|

引用文献:

---

公开号 | 申请日 | 公开日 | 申请人 | 专利标题

---

WO2009001083A1|2007-06-25|2008-12-31|Depuy International Ltd|Surgical instrument|

---

WO2011029911A1|2009-09-11|2011-03-17|Materialise N.V.|Adaptable therapeutic, diagnostic or surgical guide|

---

WO2011156748A2|2010-06-11|2011-12-15|Smith & Nephew, Inc.|Systems and methods utilizing patient-matched instruments|

---

US6558407B1|2000-10-24|2003-05-06|Tyco Healthcare Group Lp|Breast stabilizer with instrument guide|

---

US20070239159A1|2005-07-22|2007-10-11|Vertiflex, Inc.|Systems and methods for stabilization of bone structures|

---

FR2928259B1|2008-03-07|2011-04-22|D L P Sarl|MATERIAL FOR THE REDUCTION OF A FRACTURE, ESPECIALLY A DISTAL RADIUS FRACTURE|

---

US8287547B2|2008-06-23|2012-10-16|Depuy Products, Inc.|Adjustable drill guide|

---

WO2012027402A2|2010-08-23|2012-03-01|Luke Andrew Gibson|Patient-matched instruments|

---

US9138219B2|2010-12-29|2015-09-22|Tarsus Medical Inc.|Methods and devices for treating a syndesmosis injury|

---

EP2757977A1|2011-09-20|2014-07-30|The Cleveland Clinic Foundation|Method and system for producing at least one patient-specific surgical aid|

---

CA2871950C|2012-05-24|2020-08-25|Zimmer, Inc.|Patient-specific instrumentation and method for articular joint repair|

---

EP2872053A4|2012-07-15|2016-03-09|Smith & Nephew Inc|Patient matched instrument|

---

US9060788B2|2012-12-11|2015-06-23|Biomet Manufacturing, Llc|Patient-specific acetabular guide for anterior approach|US8323288B2|2007-09-30|2012-12-04|Depuy Products, Inc.|Customized patient-specific bone cutting blocks|

---

WO2017096242A1|2015-12-03|2017-06-08|Heartflow, Inc.|Systems and methods for associating medical images with a patient|

---

CN105310741B|2015-12-07|2018-01-23|上海昕健医疗技术有限公司|Total knee replacement digitizes deep guide plate|

---

US10874404B2|2016-12-30|2020-12-29|DePuy Synthes Products, Inc.|Customized patient-specific surgical instruments and method|

---

US10631878B2|2018-01-24|2020-04-28|DePuy Synthes Products, Inc.|Customized patient-specific anterior-posterior chamfer block and method|

---

US10716581B2|2018-01-24|2020-07-21|DePuy Synthes Products, Inc.|Method of designing and manufacturing low-profile customized patient-specific orthopaedic surgical instruments|

---

US10537343B2|2018-01-24|2020-01-21|DePuy Synthes Products, Inc.|Low-profile metallic customized patient-specific orthopaedic surgical instruments|

---

US11051829B2|2018-06-26|2021-07-06|DePuy Synthes Products, Inc.|Customized patient-specific orthopaedic surgical instrument|

---

US11167375B2|2018-08-10|2021-11-09|The Research Foundation For The State University Of New York|Additive manufacturing processes and additively manufactured products|

法律状态:

优先权:

---

申请号 | 申请日 | 专利标题

---

GB1402563.9|2014-02-13|

---

GB201402563A|GB201402563D0|2014-02-13|2014-02-13|Adaptive surface surgical guiding apparatuses including stability and/or verification elements|

---