阅读说明：本技术 结合扩增手术的模拟和建模的系统和方法 (System and method for simulation and modeling in conjunction with augmentation surgery ) 是由 胡安·乔斯·查康·奎洛斯 马科斯·斯福尔萨 拉法尔·G·科拉莱斯 拉古·拉加万 罗伯托·德梅 于 2019-06-21 设计创作，主要内容包括：用于设计和/或模拟包括植入物和辅助材料组合的外科扩增手术的系统和方法。一种示例性的方法包括接收植入部位的术前状态的参数,接收植入部位的术后状态的参数,从术前状态自动生成用于实现术后状态的混合策略,其中混合策略包括建议的植入物体积和建议的辅助材料体积,以及使用建议的植入物体积和建议的辅助材料体积生成植入部位的术后状态的模拟。(Systems and methods for designing and/or simulating a surgical augmentation procedure that includes a combination of an implant and an adjunct material. An exemplary method includes receiving parameters of a pre-operative state of an implant site, receiving parameters of a post-operative state of the implant site, automatically generating a hybrid strategy for achieving the post-operative state from the pre-operative state, wherein the hybrid strategy includes a proposed implant object volume and a proposed auxiliary material volume, and generating a simulation of the post-operative state of the implant site using the proposed implant object volume and the proposed auxiliary material volume.)

1. A method of simulating a surgical outcome, the method comprising:

receiving parameters of a preoperative state of an implant site;

receiving a parameter of a post-operative state of an implantation site;

automatically generating a blending strategy from the pre-operative state to achieve the post-operative state based on the parameters of the pre-operative and post-operative states, wherein the blending strategy includes a suggested implant volume and a suggested auxiliary material volume; and

generating a simulation of the post-operative state of the implantation site using the proposed implant object volume and the proposed volume of auxiliary material.

2. The method of claim 1, wherein receiving parameters of the post-operative state of the implantation site comprises:

providing a list of potential implants for the implantation site; and

a selection of an initial implant from the list of potential implants is received.

3. The method according to claim 1 or 2, wherein the parameter of the preoperative state of the implant site comprises a preoperative volume, and wherein the parameter of the postoperative state of the implant site comprises a postoperative volume.

4. The method of any of claims 1-3, wherein automatically generating the blending policy comprises:

calculating a volume difference between the post-operative state and the pre-operative state;

determining the proposed implant volume by applying a skin mass coefficient to the volume difference; and

determining the proposed volume of auxiliary material by subtracting the proposed volume of implant from a volume difference.

5. The method of claim 4, wherein the volume of the post-operative state is less than or equal to twice the volume of the pre-operative state, and wherein determining the proposed implant volume further comprises:

applying the skin mass coefficient to the volume difference to obtain a first value; and

applying the skin mass coefficient to a first value to obtain the proposed implant volume.

6. The method of claim 5, wherein the skin mass factor is between about 0.5 and about 0.7.

7. The method of any of claims 4-6, wherein determining the suggested auxiliary material volume further comprises factoring in a reabsorption rate of the auxiliary material.

8. The method of any one of claims 1-7, wherein the adjunct material comprises a fat or synthetic filler.

9. A method for simulating a surgical outcome, the method comprising:

receiving parameters of a preoperative state of an implant site;

receiving a selection of an initial implant from a digital catalog;

generating a first visual simulation of the implantation site at a first post-operative state, wherein the first post-operative state comprises the selected initial implant;

generating a second visual simulation of the implantation site at a second post-operative state, wherein the second post-operative state comprises a second implant, optionally selected from a digital catalog or database, and an adjunct volume of material;

receiving input adjusting a parameter of the second post-operative state; and

generating an adjusted second visual simulation of the implantation site in the second post-operative state to account for the adjusted parameter.

10. The method of claim 9, wherein the adjusted parameter comprises a change in distribution of the volume of the auxiliary material at the implantation site.

11. The method of claim 9 or 10, wherein the input adjusting the parameter of the second post-operative state comprises a third implant different from each of the initial implant and the second implant.

12. The method according to any one of claims 9-11, wherein the steps of receiving parameters of a preoperative state of an implantation site, receiving a selection of an initial implant from a digital directory, and receiving input to adjust parameters of the second postoperative state include receiving data from a graphical user interface.

13. The method according to any of claims 9-12, wherein the second visual simulation comprises a distribution of the volume of the adjunct material in one or more quadrants of the implantation site, and wherein the receiving input adjusting the parameter of the second post-operative state comprises receiving an indicated amount of adjunct material for addition to or subtraction from at least one quadrant of the one or more quadrants of the implantation site.

14. The method according to any one of claims 9-13, further comprising:

displaying side-by-side views of the first visual simulation and the second visual simulation.

15. The method according to any one of claims 9-14, wherein receiving parameters of the preoperative state of the implant site includes receiving digital imaging data of the implant site.

16. A method for simulating a surgical outcome, the method comprising:

receiving parameters of a preoperative state of an implant site;

generating a simulation of the implant site using the parameters of the preoperative state and a suggested implant volume;

receiving placement parameters for a volume of auxiliary material to be added to the implantation site; and

modifying the simulation of the implantation site to include the volume of auxiliary material.

17. The method of claim 16, wherein generating the simulation of the implantation site comprises dividing the implantation site into segments.

18. The method of claim 16 or 17, wherein the placement parameters of the auxiliary material volume include identifying a segment for placing the auxiliary material volume.

19. The method of claim 18, wherein modifying the simulation of the implantation site comprises:

increasing a volume of the identified segment corresponding to the volume of the secondary material; and

generating a resulting displacement at a plurality of points on a periphery of the implantation site, wherein a displacement amplitude of each of the plurality of points is inversely related to a distance between the identified segment and the point.

20. The method of any of claims 16-19, wherein the proposed implant volume corresponds to an implant in a list of potential implants, and/or wherein the auxiliary material comprises a fat or synthetic filler.

Technical Field

The present disclosure relates to systems and methods that may be used in medical procedures, such as, for example, cosmetic and/or reconstructive surgery.

Background

Aesthetic, cosmetic and reconstructive surgery refers to surgical procedures performed to repair, restore or alter the appearance of a subject's bone. For example, cosmetic surgery fields include wrinkle removal (dermabrasion), breast shaping (changing the size of the breast) and hip shaping (changing the size of the hip), and reconstructive surgery fields include implantation of prostheses and surgical operations such as reattachment of body parts of an amputated limb. In some such procedures, the surgeon implants a suitable implant at a desired site in the subject's body. In some cases, an implant alone may not provide the desired size, shape for a change in physical appearance or the subject's feel. In addition, the implant alone may produce poor weight or feel unpleasant to the subject. Furthermore, in some cases, the subject may need to wait for the surgery to end before seeing the outcome of the surgery.

Disclosure of Invention

The present disclosure discloses systems and methods for simulating surgical outcomes. In some aspects, a method for simulating a surgical outcome includes: the method includes receiving parameters of a pre-operative state of an implant site, receiving parameters of a post-operative state of the implant site, automatically generating a hybrid strategy to achieve the post-operative state from the pre-operative state based on the parameters of the pre-operative and post-operative states, wherein the hybrid strategy includes a proposed implant volume and a proposed volume of auxiliary material, and generating a simulation of the post-operative state of the implant site using the proposed implant volume and the proposed volume of auxiliary material.

Receiving parameters of a post-operative state of an implantation site may include providing a list of potential implants for the implantation site, and receiving a selection of an initial implant from the list of potential implants. For example, the parameter of the preoperative state of the implant site may include a preoperative volume and the parameter of the postoperative state of the implant site may include a postoperative volume.

According to some aspects of the disclosure, automatically generating a blending policy includes: calculating a volume difference between the post-operative state and the pre-operative state, determining a proposed implant volume by applying a skin mass coefficient to the volume difference, and determining a proposed volume of the auxiliary material by subtracting the proposed implant volume from the volume difference. In some aspects, the volume of the post-operative state may be less than or equal to twice the volume of the pre-operative state, wherein determining the proposed implant volume further comprises applying a skin mass factor to the volume difference to obtain a first value, and applying the skin mass factor to the first value to obtain the proposed implant volume. For example, the skin mass factor may be between 0.5 and 0.6. Further, according to some aspects, determining the suggested volume of the secondary material includes factoring in the reabsorption rate of the secondary material. The auxiliary material may comprise, for example, fat and/or synthetic fillers.

The present disclosure also includes a method of simulating a surgical outcome, the method comprising: receiving a parameter of a pre-operative state of an implant site, receiving a selection of an initial implant from a digital catalog, generating a first visual simulation of the implant site in a first post-operative state, wherein the first post-operative state comprises the selected initial implant, generating a second visual simulation of the implant site in a second post-operative state, wherein the second post-operative state comprises a second implant, optionally selected from the digital catalog or a database, and an auxiliary material volume, receiving an input adjusting the parameter of the second post-operative state, and generating an adjusted second visual simulation of the implant site in the second post-operative state to account for the adjusted parameter.

The adjusted parameter may include a change in the distribution of the volume of the auxiliary material at the implantation site. Further, for example, the input to adjust the second post-operative state parameter may include a third implant that is different from each of the initial implant and the second implant. The steps of receiving parameters of a preoperative state of an implantation site, receiving a selection of an initial implant from a digital directory, and receiving input to adjust parameters of a second postoperative state may include receiving data from a graphical user interface.

According to some aspects of the disclosure, the second visual simulation includes a distribution of the volume of the adjunct material in one or more quadrants of the implantation site, and receiving the input to adjust the parameter of the second post-operative state includes receiving an indicated amount of the adjunct material for addition to or subtraction from at least one of the one or more quadrants of the implantation site. The method further may include displaying side-by-side views of the first visual simulation and the second visual simulation. In some examples, receiving the parameter of the preoperative state of the implant site includes receiving digital imaging data of the implant site.

In some aspects of the present disclosure, a method for simulating a surgical outcome is provided that includes receiving parameters of a preoperative state of an implant site, generating a simulation of the implant site using the parameters of the preoperative state and a suggested implant volume, receiving placement parameters of an auxiliary material volume to be added to the implant site, and modifying the simulation of the implant site to include the auxiliary material volume. Generating the simulation of the implantation site may include, for example, dividing the implantation site into segments. In some examples, the placement parameter of the secondary material volume includes identifying a segment for placement of the secondary material volume.

Further, for example, modifying the simulation of the implantation site includes increasing a volume of the identified segment corresponding to the volume of the secondary material and generating a resulting displacement at a plurality of points on the periphery of the implantation site, wherein a magnitude of the displacement for each of the plurality of points is inversely related to a distance between the identified segment and the point. The proposed implant volume may correspond to an implant in a list of potential implants. As mentioned above, the auxiliary material may optionally comprise a fat or synthetic filling.

Drawings

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary embodiments of the disclosure. In the drawings, like reference numerals refer to like elements, where appropriate. For simplicity and clarity of illustration, the general structure and/or manner of construction of the various embodiments is depicted in the figures. Descriptions and details of well-known features and techniques may be omitted to avoid obscuring the other features. Elements in the figures have not necessarily been drawn to scale. The dimensions of some features may be exaggerated relative to other features to help improve understanding of the exemplary embodiments. For example, those of ordinary skill in the art will appreciate that some of the views may not be drawn to scale. Further, even if not specifically mentioned herein, aspects described with reference to one embodiment may be applied to and used with other embodiments.

FIG. 1 depicts in flow diagram form an exemplary method in accordance with aspects of the present disclosure;

FIG. 2 depicts, in flow diagram form, another exemplary method in accordance with aspects of the present disclosure;

FIG. 3 depicts, in flow diagram form, another exemplary method in accordance with aspects of the present disclosure;

FIG. 4 depicts, in flow diagram form, another exemplary method in accordance with aspects of the present disclosure;

5-7 depict views of an exemplary user interface according to some aspects of the present disclosure;

8-11 depict views of another exemplary user interface according to some aspects of the present disclosure;

FIG. 12 depicts, in flow diagram form, a further exemplary method in accordance with aspects of the present disclosure;

fig. 13 depicts in schematic form an exemplary system in accordance with some aspects of the present disclosure.

Detailed Description

Aspects of the present disclosure may be used to visualize physical features of a subject (such as a patient considered for a medical procedure), and to simulate changes in the appearance of the subject resulting from the medical procedure. Some aspects of the present disclosure may be used to simulate the results of cosmetic or reconstructive surgery. Advantageously, aspects of the present disclosure may allow for a hybrid approach to cosmetic procedures, such as breast augmentation surgery, hip augmentation surgery, etc., where the hybrid approach may have improved repeatability, improved predictability, and/or improved surgical results. Aspects of the present disclosure may provide, for example, procedures that reduce complications (associated with larger implant volumes and implant weights with larger volumes), and/or better options for surgeons and patients who may desire lightweight implants, and for example, not only the ability to enlarge, build or reconstruct a subject's bone, but also the ability to sculpt a subject's individual to a final result.

Embodiments of the present disclosure may provide one or more additional benefits, such as providing a simulation capability (e.g., a three-dimensional simulation capability) for surgeons and their patients performing breast augmentation and other cosmetic procedures, allowing such surgeons to simulate hybrid breast augmentation strategies that combine an implant with one or more auxiliary materials. In addition, the predicted outcome achieved by the systems and methods disclosed by the present disclosure may aid surgeons and patients by providing pre-operative consultation recommendations and surgical guidance regarding insertion/injection sites, and volumes of ancillary materials used in augmenting implants having lower volumes and smaller sizes, rather than volumes otherwise required to achieve the desired outcome.

Various aspects of the disclosure are described in more detail below. The terms and definitions used and clarified in this disclosure are intended to represent meanings within the disclosure. To the extent of conflict with terms and/or definitions incorporated by reference, the terms and definitions provided in this disclosure shall govern.

In the discussion that follows, relative terms such as "about," "approximately," and the like are used to indicate a possible ± 5% variation in the numerical values. It is to be noted that the description set forth in this disclosure is intended merely to be illustrative of the subject matter and is not intended to limit the embodiments, or the application and uses of such embodiments. Any embodiments described herein as exemplary should not be construed as preferred or advantageous over other embodiments. Rather, the term "exemplary" is used in an exemplary or descriptive sense. The terms "comprising," "including," "having," "with," and any variations thereof, are used synonymously to denote or describe a non-exclusive inclusion. Thus, a process, method, system, or apparatus that uses these terms does not include only those steps, structures, or elements, but may include other steps, structures, or elements not expressly listed or inherent to such process, method, system, or apparatus. Further, terms such as "first," "second," and the like, if used herein, do not denote any order, quantity, or importance, but rather are used to distinguish one element from another. Similarly, terms of relative orientation, such as "front," "top," "back," "bottom," "upper," "lower," etc., are with respect to the figures being described.

The term "implantation site" as used in this disclosure may refer to a portion of a body (e.g., of a human or animal subject) in which an implant is contemplated for use (e.g., implantation) in a surgical procedure. For example, an implantation site according to the present disclosure may include an area of the chest, a hip area, a genital area, an arm, a leg, a hand, a foot, or other limb or any other area of the body.

The term "implant" as used in this disclosure may refer to any biocompatible implant device designed for body shaping, such as a breast, hip, pectoral, penile, calf, or facial implant. Such implantable devices may be made of silicone (e.g., silicone), saline, plastic or other polymers or copolymers and/or other materials (e.g., biocompatible materials) that are available in the medical and cosmetic arts.

The present disclosure relates generally to surgical procedures, including the use of medical implants, including both aesthetic and reconstructive surgical procedures. Various aspects of the disclosure may be used with and/or include one or more features disclosed in the following applications: international application No. PCT/IB2017/0000247 entitled "transposers and Sensors for Implantable Medical Devices and Methods of Use Thereof", filed on 8.2.2017 and disclosed in WO 2017/137853; international application No. PCT/IB2017/000380 entitled "Medical Imaging Systems, Devices, and Methods", filed 4/4.2017 and disclosed in WO 2017/175055; international application No. PCT/US2017/027807 entitled "Apparatus for the Implantation of Medical Devices and Methods of Use Thereof, filed on 14/4/2017; international application No. PCT/US2017/031948 entitled "Medical Implants and Methods of preference theof", filed 5, 10.2017 and published in WO 2017/196973; U.S. application publication No. 2015/0282926; U.S. application publication No. 2014/0081398; and/or U.S. application publication No. 2014/0078013, each of which is incorporated herein by reference.

Methods according to the present disclosure may be performed using computing hardware and/or software. For example, one or more algorithms may be programmed on, for example, a computer or series of computers to automatically perform various aspects of the disclosed methods. Additionally, in some embodiments, the present disclosure may include an imaging and/or simulation system that may be used for or in preparation for a cosmetic procedure (or another medical procedure). The system may be used to capture, measure and/or calculate a preoperative state of the subject, and/or visualize and/or simulate the expected change in appearance of the subject resulting from the medical procedure under consideration. Additionally, the system may be used with a data storage device (e.g., computer storage, cloud storage, and/or database) that houses data identifying implants, auxiliary materials, and their characteristics to identify or suggest implants, auxiliary materials, potential implant sizes, and/or auxiliary material volumes or quantities for use in a procedure. Further, the disclosed system may be capable of simulating the use of proposed implants and/or auxiliary materials at the implantation site.

The present disclosure describes an exemplary system including imaging, modeling, recommendation, calculation, and user interface components with respect to fig. 13, discussed below. Such exemplary systems, or portions thereof, may be used to perform all or part of any of the methods disclosed in this disclosure. One of ordinary skill in the art will appreciate that any suitable computing system, imaging system, and/or user interface device may be programmed or adapted to perform some or all of the methods disclosed in the present disclosure.

Fig. 1 illustrates an example method 100 in accordance with various aspects of the present disclosure. The method 100 may include receiving preoperative parameters for an implant site (step 102), generating a simulation of a post-operative implant site (step 104), providing a catalog or database of potential implants for achieving the post-operative implant site (step 106), determining a blending strategy for achieving a target post-operative implant site based on a selected implant, the blending strategy including an implant and a volume of auxiliary material (step 108), and providing a surgical recommendation based on the blending strategy (step 110).

In general, the method 100 may result in the generation of one or more simulations of an implant site, and may use input information (e.g., user selection of an implant) to determine and output a recommended blending strategy for a surgical procedure involving the implant. The mixing strategy may include an implant volume (also referred to herein as a first volume) and an auxiliary material volume (also referred to herein as a second volume), and may be tailored to achieve a particular result at the implantation site. In some embodiments, the blending strategy may be configured to provide natural, visually and tactilely smooth and/or comfortable post-operative results at the implantation site.

Receiving preoperative parameters of an implant site in accordance with step 102 may include receiving information to assist in simulating, preparing, or performing a procedure involving the implant. For example, the preoperative parameters may include, for example, measurements of the implant site; data about an individual (e.g., a subject) whose body includes the implantation site, such as demographic data, age, gender, height, weight, physical condition, reason for the desire or need for surgery, previous surgery, and the like. In some embodiments, the pre-operative parameters may include characteristics of the implant site on the subject's body, such as skin quality (e.g., laxity), tissue health, previous surgical history, or other characteristics. In some embodiments, the preoperative parameters may include a range of sizes of the implant site, such as depth of incision, incision width and/or length, incision location, and/or tissue volume at or near the implant site. In some embodiments, the preoperative parameters may include images taken by one or more imaging devices (e.g., scanners, cameras, etc.). For example, the preoperative parameters may be collected using high resolution scanning, ultrasound imaging, high resolution photography, three-dimensional imaging, or visual inspection, among other methods. In some embodiments, the preoperative parameters may include images taken using the devices, systems, and methods disclosed in international application publication No. WO/2017/175055. In addition, preoperative parameters can be collected by examining deeper tissue properties at the implant site and surrounding area using, for example, ultrasound elastography techniques. In other variations, measurements may be made by euler video magnification techniques and variations thereof. In some embodiments, the preoperative parameters may include images that have been processed to determine one or more dimensions of, for example, an implantation site.

Generating a simulation of the post-operative implant site according to step 104 may include, for example, using the received pre-operative parameters with the expected post-operative parameters to create a visual presentation of the implant site. The post-operative parameters may include data characterizing a desired outcome of a surgical procedure at the implantation site (e.g., an augmentation procedure that includes an implant), such as a desired measurement of the post-operative implantation site (e.g., height, width, volume, shape, and/or implant type). To generate a simulation of the post-operative implantation site, the pre-operative parameters may be used as a basis or starting point from which the post-operative conditions may be determined. For example, in the case of a mastectomy, a pre-operative breast size (e.g., shape and volume) of the subject, in combination with a known shape and/or volume of the desired post-operative breast size, may be used to delineate the post-operative breast size on a simulation of the torso of the subject. In some embodiments, the generated simulation of the post-operative implantation site may include, for example, a three-dimensional visual simulation, which may be output to a user device and/or saved for reference or later use.

Providing an implant inventory or database for achieving a post-operative implant site according to step 106 may include processing pre-operative parameters of the implant site and a simulation of the post-operative implant site to determine an implant that may be used to achieve post-operative implant site characteristics. For example, to achieve a desired volume of an implant site (e.g., a volume of a body part such as the breast or buttocks) that is greater than a volume of a preoperative implant site in a post-operative state, it may be determined that a particular volume range of implants is available. Further, to achieve a desired shape, texture, weight, or compatibility with the subject's body, it may be determined that an implant having a particular shape and material composition may be suitable.

For example, in some embodiments, a circular implant may be selected, while in other embodiments, an oval, drop, or other shape may be selected. As a further example, in some embodiments, an implant with a fluid filler such as silicone or saline liquid may be selected, while in other embodiments, an implant with a structured interior, a less viscous filler material, and/or a more solid interior (including, for example, a high viscosity material, e.g., providing a "gummy bear" interior) may be selected. In some embodiments, an implant having a filling material with a viscosity and elasticity that provides gravity sensitive properties may be selected. In some embodiments, an implant having a smooth textured surface, a micro-textured surface, a rough textured surface, or a combination thereof may be selected. Exemplary features of suitable implants according to the present disclosure may be found, for example, in U.S. application publication No. 2015/0282926, U.S. application publication No. 2014/0081398, and/or international application publication No. WO 2017/196973. Providing an implant inventory may include, for example, providing a list, database, image set, etc. that identifies available implants so that a user may select one or more implants. In some embodiments, providing an implant inventory may include exporting or outputting a list, database, or group of implants to, for example, a user device (e.g., user device 1306 depicted in fig. 13).

In some embodiments, the method 100 may include receiving a selection of an implant from an implant catalog. Such selection may be made automatically, such as by a computer system performing the method 100, or may be made manually, such as by a doctor, patient, or other individual. In some embodiments, selecting an implant may assist, for example, in performing further steps according to method 100.

In general, determining a hybrid strategy for achieving a target post-operative implant site according to step 108 may include performing one or more algorithms using, for example, pre-operative parameters of the implant site and a simulation of the post-operative implant site to calculate a combination of the implant and one or more auxiliary materials that, when implanted, injected, or otherwise added to the implant site, contribute to achieving a size (volume), shape, and/or other characteristics of the post-operative implant site. One such type of algorithm is described in further detail below with reference to fig. 2. In embodiments where the implant is selected from a catalog of implants, performing step 108 optionally may include using a parameter of the selected implant, such as a volume of the selected implant, as a basis for determining the blending strategy. Step 108 may include using the simulation of the post-operative implant site and pre-operative parameters of the implant site to determine a difference between the pre-operative implant site and the post-operative implant site, such as a difference in size (volume) and/or shape. The determined difference may be used as a basis for determining a blending strategy. Additionally or alternatively, a target post-operative parameter (e.g., shape or volume) may be used as a basis for determining a blending strategy.

In some embodiments, step 108 may include determining a target post-operative volume (also referred to as a total volume in this disclosure) to be added to the implantation site, including determining a first volume to be added as an implant, and determining a second volume of auxiliary material to be added in addition to the implant, e.g., each of the first and second volumes is a fraction of the total volume to be added to the implantation site. Advantageously, adding the second volume of adjunct material to the implantation site along with the implant, rather than adding an implant that includes the entire volume to be added to the implantation site, may result in more natural, better supported, and/or customizable results from the surgical procedure.

The adjunct material can be any suitable biocompatible material for injection with, implantation in, or otherwise supplementing the implant site. Exemplary suitable materials include, for example, fats (such as allogenic or autologous fats), natural fillers, synthetic fillers, combinations thereof, and/or combinations of scaffold materials useful in the medical and cosmetic surgical fields. The particular advantages may vary depending on the type of auxiliary material selected. For example, fat grafts may provide a more natural result at the post-operative implantation site and/or better accept the implant at the implantation site (biocompatibility). As further examples, the scaffold material may allow for improved structure of the post-operative implantation site, and/or improved positioning and/or anchoring of the implant within the implantation site. In addition, the placement and compartmentalization of the adjunct material at the implantation site can be customizable to provide a customized shape or size for the post-operative implantation site.

In some embodiments, in addition to determining the implant volume (first volume) and the auxiliary material volume (second volume), determining the mixing strategy according to step 108 may include determining parameters for placing the auxiliary material volume at the implantation site. For example, in some embodiments, the implantation site may be divided into different regions (e.g., different segments and/or sub-portions). The volume of the auxiliary material may be divided between the different regions. In some embodiments, algorithms may be utilized to automatically partition the auxiliary material volume between different regions (see, e.g., fig. 12 and related discussion herein). In further embodiments, input (e.g., from a user, such as a physician or patient, or from a digital source, such as a database) may be used to determine and/or adjust the division of the volume of the auxiliary material between different materials.

As described above, determining a blending strategy may include determining a total volume to be added to the implant site. For example, the total volume may be determined by calculating a pre-operative implant site volume using, for example, pre-operative implant parameters, calculating a post-operative implant site volume using, for example, parameters of the post-operative implant site simulated in step 104, and calculating a difference between the post-operative implant site volume and the pre-operative implant site volume. Additionally or alternatively, the total volume may assume the volume of an initial implant selected from an implant inventory, which may be selected independently, or may be selected based on a difference in the calculated post-operative implant volume and the pre-operative implant volume (e.g., the initial implant whose volume is closest to the calculated difference).

In some embodiments, determining a blending strategy may include running a series of "optional" scenarios (e.g., 2, 3, 4, 5, or more scenarios) that may result in one or more simulations reflecting the implantation site of the implant of predetermined size and volume, and supplementing one or more volumes of the auxiliary material.

Providing a hybrid strategy-based surgical recommendation in accordance with step 110 may include selecting and outputting a hybrid strategy to, for example, a physician, a patient, a digital repository, or other recipient. In some embodiments, providing the surgical recommendation may include outputting the blending strategy to a user interface. In some embodiments, providing surgical advice may include recommending an implant shape, type, and/or volume and an auxiliary material volume and type. In some embodiments, the surgical recommendation may also include a recommended incision site, placement parameters of the volume of the adjunct material, and/or the volume of the adjunct material or the injection/insertion location of the implant based on, for example, physical and/or biological characteristics of the subject, the implant, and/or the adjunct material, to increase the likelihood of replicating the desired result.

Fig. 2 illustrates an example method 200 in accordance with various aspects of the present disclosure. As noted above, FIG. 2 shows the step of formulating a blending strategy (e.g., step 108 of method 100) in further detail. The method 200 may include receiving a pre-operative parameter of an implant site (step 202), receiving a target post-operative volume of the implant site (step 204), determining an approximate implant volume using the pre-operative parameter and the target post-operative volume (step 206), selecting an implant based on the approximate implant volume (step 208), determining a target auxiliary material volume based on the selected implant and the target post-operative volume (step 210), and adjusting the target auxiliary material volume based on an auxiliary material characteristic (step 212).

Receiving preoperative parameters of an implant site according to step 202 may include any and/or all aspects of step 102 described with respect to method 100. Receiving the target post-operative volume of the implantation site according to step 204 may include, for example, receiving the target post-operative volume of the implantation site from, for example, a user, and/or may include calculating, simulating, or inferring the target post-operative volume. For example, step 204 may include receiving a selection of an implant (e.g., from an implant catalog provided according to step 106 of method 100) and inferring a post-operative volume using the received pre-operative parameters of the implant site and the volume of the selected implant. In some embodiments, step 204 may include generating a simulation of the post-operative implantation site that the user may adjust (e.g., by selecting a particular implant), and then using the adjusted simulation to calculate the target post-operative volume.

Determining an approximate implant volume using the pre-operative parameters and the target post-operative volume according to step 206 may include determining how many fractions or percentages of the implant should be included in the target post-operative volume (total volume). This portion may vary based on, for example, the characteristics of the subject. For example, in some embodiments, skin laxity of a subject may affect the choice of implant volume. For example, a subject with high skin laxity may desire or require a large percentage (e.g., about 65%) of the implant to the target post-operative volume, for example, in order to properly shape and support the subject's skin, while a subject with low skin laxity may desire or require a smaller percentage (e.g., about 55%) of the implant to the target post-operative volume. The parameter skin sag may be calculated by subjective "pinching" or other suitable means to determine the amount of elasticity (elastin and/or collagen) in the skin and underlying tissue corresponding to sag.

The fraction or percentage of the target post-operative volume occupied by the implant may also or alternatively vary according to, for example, physician recommendations, patient preferences, and/or combinations thereof. In some embodiments, the percentage of the target post-operative volume to be added to the implantation site as an implant (i.e., the implant volume) may vary from, for example, about 45% to about 80%, e.g., about 50% to about 70%, about 55% to about 65%, or about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, or about 80%. In some embodiments, the percentage of the target post-operative volume to be added to the implantation site as an implant may be divided by 100 to yield a factor. In embodiments where skin mass (e.g., skin laxity) is calculated to be within a percentage of the target post-operative volume to be added as an implant, the resulting coefficient may be referred to as a skin mass coefficient.

To derive an approximate implant volume, the target post-operative volume may be multiplied by a determined factor. For example, if the determined percentage of the target post-operative volume to be occupied by the implant is 65%, and the target post-operative volume is 400cc, then the approximate implant volume may be 0.65x400cc, or 260 cc. In some cases, the target post-operative volume may be multiplied two (or more) times by a determined factor to arrive at a suitable approximate implant volume, as further described with respect to fig. 3.

Selecting an implant based on the approximated implant volume according to step 208 may include viewing one or more available implant directories or databases and selecting an implant having a near approximated implant volume. For example, an implant may be selected that has a volume that is smaller or larger than the approximate implant volume. This may explain the fact that an implant with an exact approximate implant volume is not available. For example, implants are typically produced in a limited variety of sizes. Further, a variety of factors may limit the usability of the implant, such as manufacturer or distributor inventory, desired implant shape, surface texture, fill texture, viscosity, and the like. In some cases, a physician may only selectively cooperate with one or a few brands of implants, further limiting the availability of multiple implant volumes.

In some embodiments, step 208 may be performed automatically; for example, a computer system performing method 200 may review one or more digital implant catalogs and may automatically select an implant from the reviewed catalogs. Additionally or alternatively, step 208 may include receiving a selection of an implant from, for example, a user via a user device or interface. For example, the computer system may select an implant, which may then be proposed to the user, who may accept or reject the proposed implant. If the user rejects the implant, or selects the implant independently of the computer, the user may be provided with a list of implants whose volumes are close to the approximate implant volume, and their characteristics (e.g., on the user device). The user may then select the desired implant from the list. Optionally, the user may select a magnitude of change in volume from the approximated implant volume and may view implants that fall within the selected magnitude of change in volume or less.

Determining a target volume of the auxiliary material based on the selected implant and the target post-operative volume according to step 210 may include subtracting the selected implant volume according to step 208 and the pre-operative volume of the implantation site from the target post-operative volume. In other words, upon selection of an implant for a mixing strategy, the remaining volume of the target post-operative volume may be achieved by adding a corresponding amount of auxiliary material to the implantation site when determining the mixing strategy.

The properties of the auxiliary material may affect the extent to which it replenishes the implant at the implantation site. Accordingly, the method 200 then proceeds to step 212, which includes adjusting the volume of the assist material based on the characteristics of the assist material. In this step, the volume of the auxiliary material to be added to the implantation site may be adjusted to take into account properties or behavior of the auxiliary material, such as absorption rate, reabsorption rate and/or survival rate. The resorption rate of the adjunct material (e.g., fat graft) can be, for example, between about 30% and about 60%, e.g., about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, and about 60%. Accordingly, additional amounts of auxiliary material may be added to the implantation site to account for heavy absorption rates. In this case, the total volume of the auxiliary material to be added to the implantation site can be calculated in the following manner.

For example, for an auxiliary material having a resorption rate of about 35%, the volume of auxiliary material to be added to the implantation site may be multiplied by 1.35, so that after the desired resorption of part of the auxiliary material, the remaining volume of auxiliary material at the implantation site will be the desired volume.

Once a blending strategy is formulated that includes the implant and the adjusted volume of the adjunct material, the process may continue, for example, by saving and/or providing a recommended surgical strategy to the user, or any other step.

In some embodiments, the method may be modified from the method depicted in fig. 1 and the algorithm depicted and described with respect to fig. 2 to account for certain characteristics of the subject. Specifically, in some cases, applying the determined fraction or percentage to the target post-operative volume (e.g., step 206 of method 200) provides an approximate implant volume that is greater than the target post-operative volume. This may be true, for example, when the target post-operative volume is less than twice the pre-operative volume of the implant site. In some such cases, applying the determined fraction or percentage to the target post-operative volume may yield a contemplated approximate implant volume that, when added to the pre-operative volume at the implantation site, will result in a total post-operative volume greater than the desired volume. In other such cases, this step may result in a hypothetical approximate implant volume that leaves little room for the secondary material. Method 300, while sharing several common steps with method 200, includes a query and an additional step to account for this with the correction factors. The method 300 may include receiving a pre-operative parameter of an implant site (step 302), receiving a target post-operative volume of the implant site (step 304), and applying a correction factor to the target post-operative volume based on the pre-operative parameter to determine an approximate implant volume (step 306). The method 300 may further include determining whether the post-operative volume is less than or equal to twice the pre-operative volume (step 308). If so, the method 300 may include applying a correction factor to the approximated implant volume to re-determine the approximated implant volume (step 310). If not, method 300 may include skipping step 310. The method 300 may then include selecting an implant based on the approximated implant volume (step 312).

Receiving preoperative parameters of the implantation site in accordance with step 302 may include any and/or all aspects of step 102 described with respect to method 100. Receiving a target post-operative volume of an implantation site according to step 304 may include any and/or all aspects of step 204 described with respect to method 200. Any and/or all aspects of step 206 described with respect to method 200 may be shared in accordance with step 306 applying a preoperative parameter-based correction factor to the target post-operative volume to determine an approximate implant volume, wherein the correction factor of step 306 is the fraction or percentage of the target post-operative volume determined by step 206 that should be filled by the implant, and wherein the preoperative parameter is a characteristic of the subject, such as skin laxity.

According to step 308, the method 300 may then include determining whether the target post-operative volume is less than or equal to twice the pre-operative volume. If false, the method 300 may continue to step 312. However, if the target post-operative volume of the target implantation site is indeed less than or equal to twice the pre-operative volume, the method 300 may proceed to step 310, which may include applying a correction factor to the approximated implant volume to re-determine the approximated implant volume. This step may include multiplying the approximated implant volume by the determined fraction or percentage of the target post-operative volume that should be filled by the implant to account for the relatively small total volume difference between the pre-operative volume and the target post-operative volume.

For example, if the determined percentage of the target post-operative volume occupied by the implant is 65%, and the target post-operative volume is 400cc, and the pre-operative volume of the implant site is 200cc (i.e., the target post-operative volume is less than or equal to twice the pre-operative volume of the target implant site), then the approximate implant volume may be 400cc x0.65 x0.65, or 169 cc. Thus, this step reduces the approximate implant volume to account for the total volume difference between the pre-operative volume and the target post-operative volume of only 200 cc.

In some cases, the total volume difference between the pre-operative volume and the target post-operative volume may be even smaller, so that applying the two correction factors is not sufficient. For example, the target post-operative volume may be 400cc, while the pre-operative volume of the implantation site may be 250 cc. In this case, applying the correction factor twice (to arrive at an approximate implant volume of 169cc) still results in an approximate implant volume that is greater than the total volume difference between the pre-operative volume and the target post-operative volume (in this case, 150 cc). In this case, the correction factor may be applied more than twice until the approximate implant volume is less than the total volume difference between the pre-operative volume and the target post-operative volume. Finally, selecting an implant based on the approximated implant volume according to step 312 may include any and/or all aspects of step 208 described with respect to method 200.

As already mentioned in the discussion of fig. 1-3, aspects of the disclosed methods may include receiving and/or transmitting output from and/or to a user device, such as having a user interface, which may be a visual user interface. Such input and output may allow a user (e.g., a physician, subject, or other user) to view and change various aspects of the potential surgical approach to achieve a more tailored end result. Fig. 4 illustrates an example method 400 in accordance with various aspects of the present disclosure. The method 400 may include receiving a selection of an initial implant, for example, from a digital catalog (step 402), generating a first visual simulation of a post-operative implantation site including the selected initial implant (step 404), generating a second visual simulation of the post-operative implantation site including a second implant and a volume of auxiliary material (step 406), receiving input adjusting parameters of the second visual simulation (step 408), and generating the adjusted second visual simulation to account for the adjusted parameters (step 410).

As with other methods disclosed in this disclosure, the steps of method 400 may be performed by, for example, a system (e.g., system 1300) that includes computing hardware and software. In some embodiments, the step of receiving input (e.g., steps 402 and 408) may include receiving input from a user device (e.g., device 1306), and the step of generating or adjusting a visual simulation may include using a computer system (e.g., computer system 1304), and/or more particularly using a modeling engine (e.g., modeling engine 1310). The configuration and relative location of the user device and the computer system will be further described with respect to system 1300, but in general, may have any suitable configuration or location for performing the steps of method 400.

Receiving a selection of an initial implant from the digital catalog according to step 402 may include, for example, receiving an identification of a particular implant in the digital catalog and/or receiving a volume, size, fill type, and/or other characteristics of the initial implant. The digital catalog may be, for example, a custom list or database provided according to step 106 of method 100, or may be a pre-existing list or database. For example, in some embodiments, a digital catalog may be provided to the user interface, and the user interface may subsequently receive a user selection of the initial implant.

Generating a first visual simulation of a post-operative implantation site including the selected initial implant according to step 404 may include constructing an image of an implantation site into which the selected initial implant has been implanted or placed using parameters of the pre-operative implantation site (e.g., parameters received according to step 102 of method 100, step 202 of method 200, or step 302 of method 300) in combination with parameters of the selected initial implant. In some embodiments, generating such a visual simulation may include, for example, generating a three-dimensional visual simulation using, for example, imaging data of the subject and adjusting it to simulate the addition of the selected initial implant. Any of the three-dimensional simulation and/or related methods and algorithms disclosed in international application number PCT/US2019/034667 filed on 30/5/2019 (incorporated herein by reference) may be used in the present disclosure.

For example, the method of the present disclosure may include generating and/or manipulating a simulation using a three-dimensional model that includes a plurality of tetrahedrons (breast tissue in a breast volume model) for describing a tissue volume. The simulation may be based on a three-dimensional model corresponding to the initial configuration, where the model may be modified to simulate the expansion or stretching of tissue to accommodate the placement of the implants and auxiliary materials disclosed in the present disclosure. For example, a set of reference tetrahedrons of increasing volume can be defined, wherein the reference tetrahedrons correspond to planned regions of increasing volume. Further details regarding the generation and modification of such three-dimensional models to simulate the results of an anticipated medical procedure are provided in PCT/US2019/034667 filed on 30/5/2019.

Generating a second visual simulation of the post-operative implantation site including the second implant and the volume of auxiliary material according to step 406 may include, for example, receiving or calculating a potential blending strategy including the implant volume (the selected initial implant with the implant volume) and the volume of auxiliary material, and constructing a simulation of the blending strategy. In some embodiments, the visual simulation generated according to step 406 may include a standard or default distribution of the volume of the auxiliary material in the implantation site. In other embodiments, the visual simulation generated according to step 406 does not include a volume of the auxiliary material distributed at the implantation site, and may simply note the available volume of the auxiliary material, which may be added to the simulation in a custom distribution.

In some embodiments, the first visual simulation and/or the second visual simulation may be output to, for example, a user interface. For example, a comparison view of the first and second visual simulations may be provided, for example, to allow a user to view similarities and differences between using the initially selected implant and using the hybrid strategy at the implantation site. The presentation of the first visual simulation and/or the second visual simulation optionally may include interactive elements (e.g., sliders, buttons, gauges, color coding, etc.) on a user interface of the device to allow a user to change or otherwise interact and operate with the visual simulation.

Receiving input to adjust parameters of the second visual simulation in accordance with step 408 may include receiving changes from a user through such interactive elements. This step may include receiving a change in any parameter of the second visual simulation corresponding to a change in the surgical procedure or material used. For example, variations in implant size, implant shape, implant type, implant placement location, volume of the secondary material, and/or distribution of the secondary material may be received.

Generating the adjusted second visual simulation to account for the adjusted parameters according to step 410 may include performing any necessary recalculation to reflect the adjustment in the second visual simulation in response to the received input, regenerating or changing the second visual simulation according to the recalculation, and/or outputting the adjusted second visual simulation. In this manner, the user can interact with the visual simulation to observe the effect of various options and adjustments on the surgical outcome and to see similarities and differences between methods using only the selected initial implant and methods using the second implant and the volume of the auxiliary material (e.g., hybrid methods).

In some embodiments, adjustments of the first and second visual simulations may be received. In other embodiments, the adjustment may be received only for the second visual simulation. In general, the method 400 may assist a user in visualizing, customizing, and otherwise preparing a desired surgical procedure that includes an implant.

Some embodiments of the present disclosure may facilitate collaboration between a subject (e.g., a patient) and a physician (e.g., a surgeon). For example, in some embodiments of the present disclosure, the patient may select a desired shape and size of the post-operative implant site. The patient's measurements may be taken on, for example, a three-dimensional image of the implant site on the client (where the three-dimensional image may be acquired by a camera, such as a scanner's camera), and the patient's desired simulation of the post-operative implant site may be combined with the patient's measurements to obtain a simulation of the target post-operative implant site. Thereupon, computer-implemented changes regarding the surgeon's selection of a breast implant may be output based on one or more methods described in the present disclosure. The algorithm may compare the volumes and shapes (e.g., surface curvatures, areas, etc.) of different implants to find a potentially best match to the final desired shape and size. Additionally, the algorithm may rank the implants based on initial measurements and additional geometric calculations of the patient, which may be based on physical and/or mechanical properties of the implants, physicochemical properties of the auxiliary materials, and/or may be based on other considerations.

Reference will now be made to views of exemplary user interfaces that may be used with various aspects of the present disclosure. A user interface suitable for use in conjunction with the methods of the present disclosure may generally allow a user to view, select and adjust, and/or save, load, transmit, or otherwise use the generated simulation to consider or prepare a surgical procedure. Accordingly, a user interface according to the present disclosure may include any suitable displays, interactive elements, options, etc. to achieve these goals. The views described herein are merely limited examples, and those of ordinary skill in the art will understand that many more variations on the exemplary user interface are possible and are contemplated herein.

Fig. 5-7 depict views 500, 600, 700 of an exemplary user interface for, for example, simulating, modeling, designing, and preparing for aesthetic or reconstructive surgery. The view 500 may include a preoperative visual simulation 510 of the implantation site (in this case, the torso is depicted). View 500 also includes a simulation settings menu 520, including various general simulation settings, an implant selection menu 530 listing a plurality of implants that can be selected and added to the simulation (e.g., listing dimensions of each of the plurality of implants), and a simulation use menu 540, including options that can facilitate using the generated simulation in various ways.

The pre-operative visual simulation 510 may be a simulation generated according to aspects of the present disclosure and any suitable method (e.g., using images, parameters, measurements, or other data related to the subject, as disclosed elsewhere in the present disclosure). In general, the pre-operative visual simulation 510 may depict the implant site of a subject in a pre-operative state, i.e., prior to an intended surgery to insert one or more implants into the body of the subject. In some embodiments, simulation 510 may be a three-dimensional simulation, such as a three-dimensional rendering. In some embodiments, simulation 510 may be interactive (e.g., rotatable, scalable, extensible, etc.). The simulation 510 may assist a user in visualizing and analyzing the initial state (e.g., size, shape, appearance) of the implant site.

The simulation settings menu 520 may include one or more selectable options to customize the desired surgical procedure. As one example, menu 520 includes options to select one or more implant locations, to select a type of surgical procedure, and to view a type of digital directory. The type of digital catalog may vary depending on, for example, implant brand (manufacturer), implant model, shape, texture, etc. Implant selection menu 530 may include a list or other presentation of potential implants to be included at the implantation site. For example, the implant selection menu 530 may include various sizes (e.g., volumes, diameters, shapes, etc.). The simulation use menu 540 may include options for implementing, changing, comparing, etc. one or more implants in the simulation.

Fig. 6 depicts a view 600 including a post-operative visual simulation 610 of an implantation site including an implant of a selected size. View 600 may include one or more menus that are the same as view 500, such as, for example, simulation settings menu 520, and may include one or more views that are different or different from the menus displayed in view 500. For example, an exemplary implant size menu 630 is shown that can list various volumes of a single implant shape.

The post-operative visual simulation 610 may be a simulation generated according to aspects of the present disclosure and any suitable method (e.g., using images, parameters, measurements, or other data related to the subject, as disclosed elsewhere in the present disclosure). Generally, the post-operative visual simulation 610 may depict an implantation site of the subject in a post-operative state, i.e., including one or more implants. In some embodiments, the post-operative visual simulation 610 may depict a standard implantation procedure in which, for example, the implant accounts for the entire volumetric difference of the implantation site (as opposed to a hybrid strategy that includes the implant and the volume of the auxiliary material). As with simulation 510, simulation 610 may be a three-dimensional simulation, such as a three-dimensional rendering, and may likewise be interactive (e.g., rotatable, scalable, extensible, etc.). The simulation 610 may help a user visualize and analyze the initial state (e.g., size, shape, appearance) of the implantation site.

The implant size menu 630 may be a variant or sub-menu of the implant selection menu 530 depicted in view 500, for example. The implant size menu 630 may be depicted when selecting an option to view an implant having a particular shape (e.g., a circular implant, as opposed to an anatomically shaped implant). In some embodiments, the implant size menu 630 may include fewer implant options than, for example, the implant selection menu 530, to allow a user to view and select an implant having a particular characteristic (in this case, a circular shape). One of ordinary skill in the art will appreciate that many other types of implant selection menus are possible and are contemplated herein.

Fig. 7 depicts a view 700 that may include a hybrid post-operative visual simulation 710 of an implantation site that includes a selected size of implant and volume of auxiliary material (e.g., fat). View 700 may also include one or more menus identical to views 500 and 600. The view 700 may include menus specific to post-mixing simulation, such as, for example, a shaping settings menu 720 and an auxiliary materials distribution menu 730.

The hybrid post-operative visual simulation 710 may be a simulation generated according to various aspects of the present disclosure and any suitable method (e.g., using images, parameters, measurements, or other data related to the subject as disclosed elsewhere in the present disclosure, in conjunction with a calculated combination of implants and auxiliary materials). In general, the hybrid post-operative visual simulation 710 may depict the implant site of a subject in a post-operative state, including the implant (or both implants, in the case of double breast surgery as shown) and the volume of auxiliary materials. As with simulations 510 and 610, simulation 710 may be a three-dimensional simulation, such as a three-dimensional rendering, and may likewise be interactive (e.g., rotatable, scalable, extensible, etc.). The simulation 710 may assist the user in visualizing and analyzing the hybrid approach to the surgical procedure, and may allow the user to "shape" or otherwise alter the hybrid approach (e.g., by changing the distribution of the auxiliary material) to arrive at a customized target post-operative result.

The shaping settings menu 720 may include options such as changing the implant size or volume of auxiliary material for a selected implant site (here, left or right breast). As shown, the recommended implant size may be displayed. The recommended implant size may be calculated according to the algorithms and/or methods disclosed in this disclosure (e.g., according to methods 100, 200, and/or 300). Interactive components (e.g., sliders, meters, buttons, or numeric input fields) may allow for the desired change in post-operative volume. The recommended implant size may change in response to a change in the desired post-operative volume (e.g., the user interface may dynamically provide the recommended implant size based on the change to the desired post-operative volume).

The auxiliary material distribution menu 730 may include, for example, a division of the implantation site into portions (e.g., quadrants, as shown, or other portions), and may allow a user to add, subtract, or otherwise change the auxiliary material distribution to the implantation site for each portion via interactive components (e.g., sliders, meters, buttons, numeric input fields, etc.). Algorithms may be employed to dynamically update the simulation, for example, based on adjustments made in the auxiliary material distribution menu. In some embodiments, a smoothing algorithm may also be employed to maintain a perfectly smooth (e.g., well-integrated) appearance of the implantation site despite changes made to the simulation in the auxiliary material distribution menu 730. An exemplary method of updating a simulation based on changes made to the distribution of the auxiliary material is described herein with respect to FIG. 12.

In some embodiments, views 500, 600, and 700 may all be displayed simultaneously (e.g., in separate windows). In some embodiments, the views 500, 600, and 700 may be switched between to compare the simulations displayed in each view. In other embodiments, an option to directly view side-by-side comparisons of different simulations may be provided (e.g., see FIG. 11).

Fig. 8-11 depict views 800, 900, 1000, 1100 of another exemplary user interface for, for example, simulating, modeling, designing, and preparing a cosmetic surgical procedure. For example, view 800 may include a pre-operative visual simulation 810 of an implant site, and a post-operative visual simulation comparison 820 of the implant site. The post-operative visual simulation adjustment menu 830 may allow the post-operative visual simulation 820 to be changed. The simulation use menu 840 may include options to facilitate use of the generated simulation in various ways.

The pre-operative visual simulation 810 may share characteristics with the pre-operative visual simulation 510 of the view 500, for example. The post-operative visual simulation 820 may likewise share characteristics with the post-operative visual simulation 610 of view 600, for example. View 800 allows for viewing both pre-operative and post-operative visual simulations simultaneously for a more direct comparison therebetween. In some embodiments, both the pre-operative visual simulation 810 and the post-operative visual simulation 820 may be rotatable, expandable, or otherwise serially viewable, such that similar views of both simulations may be simultaneously examined.

The adjustment menu 830 may be an interactive element or collection of interactive elements that allow the user to adjust the post-operative visual simulation 820. In some embodiments, the post-operative visual simulation 820 may be dynamically changed according to adjustments made in the adjustment menu 830. The adjustment menu 830 may include options to change, for example, the post-operative volume, shape, height, projection, or other characteristics of the implant site. Additionally, the post-operative visual simulation 820 and/or the adjustment menu 830 may display, for example, digital characteristics of the implant site in the post-operative visual simulation 820. For example, as the post-operative visual simulation 820 is adjusted, the post-operative volume and/or other dimensions of the implant site may be dynamically calculated by calculating, for example, the difference between the pre-operative visual simulation 810 and the post-operative visual simulation 820 in real time or periodically. Accordingly, the post-operative volume and/or diameter (and/or other dimensions) of the implantation site may be indicated as part of the post-operative visual simulation 820 and/or the adjustment menu 830. In this manner, view 800 may allow a user to adjust and view characteristics of the post-operative implant site until a desired post-operative implant site is achieved. In some embodiments, achieving a desired post-operative implant site through adjustment, for example, using adjustment menu 830, may also be a post-operative volume option.

The simulation use menu 840 may include various selectable options to facilitate use of the simulation. For example, the simulation usage menu 840 may include options to load, print, save, analyze, annotate, or visually present one or more simulations. The simulation usage menu 840 may be provided over multiple views, such as a user interface, to allow the simulation to be saved, loaded, and otherwise manipulated from any of the multiple views.

Fig. 9 depicts a view 900, which may include a post-operative visual simulation 820, an adjustment menu 830, an implant search menu 930, and an implant selection menu 940. View 900 may include one or more menus identical to view 800, such as simulated use menu 840.

The implant search menu 930 may receive input from a user to populate the implant selection menu 940 with a list of implants compatible with the characteristics of the post-operative visual simulation 820. For example, in some embodiments, the implant search menu 930 may receive input of search criteria, such as a particular implant brand, shape, or having a particular texture or fill type. The implant selection menu 940 may list implants that meet the search criteria, which also have measurements that may be suitable for performing post-operative visual simulation from, for example, a pre-operative implant site. Some implants in the implant selection menu 940 may be determined to be mix-compatible implants, i.e., they may be used in conjunction with the auxiliary material volume as part of a mixing strategy. The user may then select an implant from an implant selection menu 940 to further refine the post-operative visual simulation 820.

Fig. 10 depicts a close-up portion of view 900 in which a hybrid compatible implant has been selected from implant selection menu 940. Upon selection of a hybrid compatible implant, a button 1010 that allows generation of a hybrid strategy may be digitally added to the view 900. Button 1010 may generate a new post-operative hybrid simulation, as depicted in fig. 11.

Fig. 11 depicts a view 1100 that may include comparisons of several simulations, such as a pre-operative visual simulation 810, a post-operative visual simulation 820, and a hybrid post-operative visual simulation 1110. The view 1100 may include an adjustment tool 1120, which may allow a user to adjust parameters of, for example, the post-operative visual simulation 920 and/or the hybrid post-operative visual simulation 1110. Further, view 1100 depicts a measurement line 815, which may be applied by a user or digitally to identify different portions of an implant site. Although the measurement line 815 is depicted on the pre-operative visual simulation 815, a similar measurement line may be applied to the post-operative visual simulation 820 or the hybrid post-operative visual simulation 1110.

The hybrid post-operative visual simulation 1110 may share any or all of the characteristics with the hybrid post-operative visual simulation 710, e.g., view 700. In general, the hybrid post-operative visual simulation 1110 may depict the implant site of a subject in a post-operative state, including the volume of implant and ancillary materials based on selections made from the implant selection menu 940. As with other simulations disclosed in this disclosure, simulation 1110 may be a three-dimensional simulation, such as a three-dimensional rendering, and may likewise be interactive (e.g., rotatable, scalable, extensible, etc.). The simulation 1110 may assist the user in visualizing and analyzing a hybrid approach to the surgical procedure. The adjustment tool 1120 can allow a user to input commands to "shape" or otherwise change the mixing method (e.g., by changing the auxiliary material volume, distribution, or type) to arrive at a customized target post-operative result.

Methods for simulating the addition of a volume of an auxiliary material to an implantation site may benefit from algorithms that can automatically dispense auxiliary material in a realistic and suitable manner around an implant/implantation site, for example. Such an algorithm may be run as part of, for example, a modeling engine (see, e.g., modeling engine 1310 of system 1300). In general, algorithms may help the modeling engine to simulate the addition or removal of auxiliary material to or from one or more segments of the implantation site, and may advantageously allow for greater control and customization in the simulation of auxiliary material at the implantation site. For example, segmentation of the implantation site may provide greater precision in the parameters used to place the adjunct material at the implantation site. The segments of the implantation site may be numerically determined once, for example, to determine the periphery and/or center of the implantation site. For example, for a mammoplasty, the simulated breast area may be digitally separated into four quadrants, which may intersect at the point of maximum bulge or at the nipple portion of the breast.

In simulating the addition or subtraction of auxiliary material at a segment of an implantation site, a method according to the present disclosure and an algorithm implementing such a method may address two goals: simulating an actual increase (or decrease) in resting volume of one or more digital segments of the implantation site realistically delineates the perimeter of these segments and/or the implantation site, thereby maintaining a smooth transition between intra-segment and extra-segment sites (e.g., inside or outside the implantation site).

To achieve both goals, the segments of the implantation site may be further divided into geometric sub-portions (e.g., tetrahedrons or other suitable shapes). For example, in some embodiments, a tetrahedral model (e.g., a breast model) of the implantation site may be constructed from triangular mesh surfaces. Each sub-portion may be identified or characterized by a distance between the sub-portion (e.g., a center point of the sub-portion) and a reference point (e.g., a center or center of the implant site, a point on a periphery of the implant site, or both). The segments may be divided into sub-sections small enough to allow realistic modeling without unduly burdening the processing power of, for example, a modeling engine.

In some embodiments, the segments and/or sub-portions may be selected and oriented based on the general location of the implantation site. For example, in the case of a breast implantation site, the subject's chest wall may be used to orient the coordinate system for dividing the implantation site into segments and/or sub-portions. A rotation matrix may be formed that rotates the center point of the sub-portion (e.g., the tetrahedral center point) from the global space to the direction of the chest wall. Points in the coordinate system may be transformed such that the nipple position is at the origin of the coordinate system. Each of the four quadrants of the coordinate system may then be translated into one of the four segments that make up the breast implantation site (e.g., such that the points of x < 0 and y < 0 correspond to the southwest quadrant, the points of x > 0 and y < 0 correspond to the southeast quadrant, the points of x < 0 and y > 0 correspond to the northwest quadrant, and the points of x > 0 and y > 0 correspond to the northeast quadrant).

To simulate the volume increase of a segment of the implantation site, the modeling engine may increase the volume of a sub-portion in the segment by some fraction of the pre-operative or other original volume. The scaling factor for the volume increase may be calculated from the original volume of the segment and the added volume of the auxiliary material. The volume increase may be reduced from sub-portion to sub-portion, depending on the characteristics of each sub-portion, so that there is a greater volume increase in the center of the segment than in the periphery of the segment. This may allow for a smoother transition between the segments. Furthermore, the volume increase may be decreased according to additional reference points, such as the body surface of the subject, the direction of the gravitational force, and the like.

To simulate a realistic/smooth contour at the perimeter of the implant site, the modeling engine may separate the boundary region of the segment into a plurality of points, and may apply a displacement to each point according to the distance between the point and the nearest point of the surface outside the segment (e.g., a perimeter point outside the implant site). The boundary region may be determined, for example, by an algorithm, or may be determined using user input. The displacement amplitude of each of the plurality of points may be inversely related to the distance between the segment and the point. For example, a fraction of the displacement towards the perimeter point may be applied to each point within the bounding region, where the fraction decays to zero as the distance between each point and the nearest perimeter point decreases. One exemplary function implemented to achieve this is:

where d is the distance from the nearest perimeter point, Dmax is the width of the bounding region (i.e., d ≦ Dmax), and e is a selectable decay exponent parameter.

Fig. 12 illustrates an example method 1200 of delineating a perimeter, in accordance with aspects of the present disclosure. The method 1200 may include receiving data regarding a volume of material to be added to an implant site (step 1202), separating the implant site into a plurality of regions (step 1204), separating each region into a plurality of sub-regions (step 1206), simulating addition of the volume of material to the region of the implant site by increasing the volume of each of the sub-regions in the region, wherein the volume of each sub-region increases as a function of the distance between the sub-region and the origin (step 1208), and performing a smoothing algorithm to simulate a smooth change in volume between the region of the implant site and the site outside the region (step 1210).

Receiving data regarding the volume of material to be added to the implant site, according to step 1202, may include receiving, for example, a manual input or an automatic suggestion of a volume of auxiliary material to be added to the implant site. Separating the implant site into regions according to step 1204 may be as described above, for example, by identifying quadrants or other portions of the implant site based on a central point, center, or periphery of the implant site. The separation of each region into sub-regions according to step 1206 may also be as described above, for example, by separating each segment into sub-portions and characterizing each sub-portion by the distance between the central point and one or more reference points (e.g., the center, or periphery of the segment or implant site). Simulating the addition of a volume of material to a region of an implantation site according to step 1208 may include identifying sub-portions located within the region (e.g., segment) and increasing their reference volume. For example, if the total starting volume of the sub-portions in a region or segment is characterized by V0, and vf is the volume of auxiliary material to be added to the region or segment, then the reference volume of each sub-portion in the region or segment may be increased by a factor of s:

s＝(V₀+vf)/V₀equation 3

In some embodiments, the modeling engine may apply this or a similar algorithm to a segment or region and will move to a solution in the segment or region where each sub-portion is a coefficient s that is larger than its initial size. As described above, the volume to be added to each sub-portion may be tapered in association with the distance between the center point of the sub-portion and the perimeter or other reference point of the region or segment. Performing a smoothing algorithm according to step 1210 to simulate a smooth change in volume between a region of the implantation site and a site outside the region may include applying equation 2 to points in the boundary site, e.g., the region.

The disclosed embodiments of the present disclosure may be created, executed, displayed, etc. using any suitable technique or system. In some embodiments, the methods disclosed in the present disclosure may be performed using one or more computer systems. Fig. 13 depicts a high-level schematic diagram of an exemplary system 1300 for performing the methods (e.g., methods 100, 200, 300, 400, 1200) described in the present disclosure. In particular, fig. 13 depicts an imaging system 1302, a computer system 1304, and a user device 1306, all of which may be connected to an electronic network 1320.

The system 1300 is merely exemplary, and one of ordinary skill in the art will appreciate that the system 1300 may have any configuration suitable for facilitating the performance, display, etc. of the disclosed embodiments of the present disclosure. In some embodiments, the components of system 1300 (e.g., imaging system 1302, computer system 1304, and user device 1306) may be part of a unit device or system. In other embodiments, the components of system 1300 may each comprise a separate device, computer, or group of computers.

Imaging system 1302 may be any imaging system suitable for, for example, receiving imaging data characterizing an implant site. As already described elsewhere in this disclosure, the imaging data may include two-dimensional or three-dimensional images, physical measurements, or any other data suitable for creating a simulation and/or analysis of the implant site. In some embodiments, the imaging system 1302 may include one or more image acquisition devices intended to acquire two-dimensional and three-dimensional images of the bone, such as a camera, a scanner (e.g., including one or more cameras), an X-ray device, a computed tomography device, a magnetic resonance imaging device, a positron emission tomography device, and/or other devices. In some embodiments, imaging system 1302 may include a scanner specifically designed to obtain detailed visual data to help simulate an implant site. For example, imaging system 1302 may include various aspects of the systems disclosed in international application publication No. WO2017/175055, which is incorporated by reference herein in its entirety. The imaging system 1302 may be located, for example, at a medical facility, office, educational facility, home, or any other suitable location. In some embodiments, imaging system 1302 may be portable. In some embodiments, it is contemplated that system 1300 may include multiple types of imaging systems 1302.

Computer system 1304 may include one or more computers configured to process, store, create, and/or manipulate images and data received from, for example, imaging system 1302 and/or user device 1306. In some embodiments, the computer system 1304 may be combined with the imaging system 1302 and/or the user device 1306 into a single device or system. In other embodiments, the computer system 1304 may receive and/or transmit data to the imaging system 1302 and/or the user device 1306 over the network 1320. Computer system 1304 may include, for example, a storage module 1312 for storing images and data and a processing module 1308 for processing and manipulating images and data. The computer system 1304 may also include a modeling engine 1310 that may create and/or update simulations using images and data received from the imaging system 1302 and/or the user device 1306 and/or images and data stored in the storage module 1312. The computer system 1304 may also include, for example, a recommendation engine 1314, which may generate and/or update recommendations or recommendations for one or more surgical parameters (e.g., implant size and/or volume of auxiliary material). In some embodiments, the modeling engine 1310 and the recommendation engine 1314 may receive and transmit data and/or perform aspects of the methods disclosed herein (e.g., methods 100, 200, 300, 400, 1200) together or separately.

The storage module 1312 may include one or more computers, computer processors, hard disks, cloud-based storage systems, and/or other systems configured to electronically store data and/or images. The storage module 1312 may store the received data in, for example, one or more databases, digital file systems, and/or cloud-based storage systems. Further, the computer system 1304 may process the received data in a processing module 1308.

The processing module 1308 can process the data by, for example, cataloging the received data, sorting the data by one or more categories, such as by patient, bone feature, intervention, measurement device, date created, date received, and the like. Such processing may also include analyzing the data and/or selecting the data to send to the modeling engine 1310 and/or the recommendation engine 1314. Storage module 1312 and/or processing module 1308 may send the received data to modeling engine 1310 and/or recommendation engine 1314 before or after storage and/or processing.

The storage module 1312, processing module 1308, modeling engine 1310, and recommendation engine 1314 may each or all be, for example, one or more computer processors, computer storage devices, and/or combinations thereof. The modeling engine 1310 may generate and/or update a simulation (e.g., a three-dimensional visualization simulation) according to an embodiment of the present disclosure using relevant data received from the storage module 1312 and/or the processing module 1308. The recommendation engine 1314 may execute one or more algorithms to generate recommended strategies for one or more surgical procedures (e.g., hybrid surgical procedures) based at least in part on the data received from the storage module 1312 processing module 1308 and/or the simulations created or updated by the modeling engine 1310, in accordance with various aspects of embodiments of the present disclosure.

Modeling engine 1310 and/or recommendation engine 1314 may be located on any hardware capable of causing it to perform the functions described herein. For example, modeling engine 1310 and recommendation engine 1314 may operate on a single computer, or may be a group of networked computers, e.g., working in series or in parallel. In further embodiments, the functionality of the modeling engine 1310 and the recommendation engine 1314 may be shared by two computers or four or more computers.

User device 1306 may be any device suitable to facilitate user interaction with a simulation of an implant site-e.g., creating, modifying, or viewing a simulation of a pre-or post-operative implant site to create, customize, or otherwise prepare a surgical procedure including an implant. User devices 1306 may include, for example, devices that allow output of simulations, recommendations, and/or recommendations of surgical procedures to a user. User device 1306 may also allow for input of subject data, implant data, auxiliary material data, parameters, measurements, and/or adjustments to measurements to create or modify simulations. The user may be a doctor, a patient, a potential patient, or any other individual. In some embodiments, user device 1306 may be a computing device, such as, for example, a personal computer or a computer associated with a medical facility, a tablet, or a mobile device. In general, user device 1306 may be any computing device with a graphical user interface.

The network 1320 may be a wired or wireless network, such as a computer processor, electronic storage device, etc., such as the internet, a local area network, a wide area network, or any other computer network configuration known in the art. In some embodiments, the network 1320 may be a single geographic region that is completely local, such as a single medical facility, office, or server system. In other embodiments, the network 1320 may connect various aspects of the system 1300 across different geographic regions, e.g., different medical facilities, offices, cities, countries, or continents.

The following examples are intended to illustrate the present disclosure, but are not limiting. It is to be understood that the disclosure encompasses other embodiments consistent with the foregoing description and the following examples.

Examples of the invention

Example 1

The preoperative breast volume for a patient is 150cc, and the patient surgeon selects 400cc of implant. Based on the patient's skin laxity, an implant volume of 65% is desired compared to the total breast volume (i.e., an implant volume of 65% of the desired total breast volume based on the patient's skin laxity). The computer system runs an algorithm that makes the following determinations:

150cc +400cc 550cc (expected total breast volume)

500cc (total desired breast volume) x0.65 (coefficient based on desired implant volume) 357.5cc (total desired implant volume, given patient's skin laxity).

The closest available volume implant with a desired implant volume below 550cc is the 350cc implant. The computer system includes this implant as part of the hybrid strategy recommendation. The computer system then determines a residual volume by subtracting the implant volume from the desired breast total volume and the existing patient tissue (preoperative breast volume).

550cc (total desired breast volume) -350cc (available implant volume) -150cc (preoperative breast volume) 50cc (calculated volume of auxiliary material).

The selected auxiliary material is autologous fat, which has a resorption rate of 35% or 0.35. Thus, the computer system calculates the auxiliary material volume based on the reabsorption rate as follows: 50cc x 1.35 (to allow for predicted reabsorption) 67cc (recommended fat volume). The computer system takes this volume as part of the blending policy recommendation.

Thus, in the case where the surgeon initially selects 400cc of implant, the algorithm recommends a hybrid approach of 350cc implant and 77cc autologous fat. This hybrid approach provides a more natural look and feel to the patient.

Example 2

The patient had a preoperative breast volume of 200cc, and the patient's surgeon selected 200cc of implant. Based on the patient's skin laxity, an implant volume of 65% is desired compared to the total breast volume (i.e., an implant volume of 65% of the total desired breast volume based on the patient's skin laxity). The computer system runs an algorithm that makes the following determinations:

200cc +200cc 400cc (expected total breast volume)

400cc (desired total breast volume) x0.65 (coefficient based on desired implant volume) 260 cc.

This factor is applied again since the total breast volume is expected to be less than or equal to twice the preoperative breast volume of the patient.

260cc × 0.65-169 cc (total desired implant volume, given patient's skin laxity).

The implant with the closest available volume below the desired implant volume is a 155cc implant. The computer system includes this implant as part of the hybrid strategy recommendation. The computer system then determines a residual volume by subtracting the implant volume from the desired breast total volume and the existing patient tissue (preoperative breast volume).

400cc (total desired breast volume) -155cc (available implant volume) -200cc (preoperative breast volume) 45cc (calculated volume of auxiliary material).

The auxiliary material selected is autologous fat, with a resorption rate of 50% or 0.5%. Thus, the computer system calculates the auxiliary material volume based on the reabsorption rate as follows: 45cc x 1.5 (to allow for predicted reabsorption) 67.5cc (recommended fat volume). The computer system takes this volume as part of the blending policy recommendation.

Thus, in the case where the surgeon initially selects 200cc of implant, the algorithm recommends a hybrid approach of 133cc implant and about 67cc autologous fat.

Although the figures and disclosure herein describe several exemplary configurations of transponders, sensors, assemblies, readers, implants and several exemplary methods of use thereof, one of ordinary skill in the art will appreciate that many other configurations and methods of variation are possible and may be suitable for a given implant, patient, procedure or application based on the implant size, shape, orientation, and predetermined location within the patient's body. The examples of apparatus, systems, and methods herein are intended to be illustrative, rather than comprehensive; one of ordinary skill in the art will also appreciate that certain variations of the devices, systems, and methods disclosed herein are also contemplated in the present disclosure.