Invented by Steven M. Goetz, Medtronic Inc

The market for systems for planning the implantation of a medical device mounted on the cranium is experiencing significant growth due to advancements in medical technology and an increasing demand for innovative treatment options. This market segment plays a crucial role in ensuring the successful and precise placement of medical devices on the cranium, such as deep brain stimulation (DBS) electrodes, cochlear implants, and neurostimulators. The cranium, being a delicate and complex structure, requires careful planning and precise execution when implanting medical devices. This is where planning systems come into play, providing surgeons and medical professionals with the necessary tools to accurately map out the patient’s anatomy, identify optimal implantation sites, and plan the surgical procedure accordingly. One of the key factors driving the growth of this market is the rising prevalence of neurological disorders and conditions that can be treated with cranial implants. Conditions such as Parkinson’s disease, epilepsy, and hearing loss are becoming increasingly common, leading to a higher demand for medical devices that can alleviate symptoms and improve patients’ quality of life. Moreover, technological advancements have greatly improved the accuracy and efficiency of planning systems. These systems utilize advanced imaging techniques, such as magnetic resonance imaging (MRI) and computed tomography (CT) scans, to create detailed 3D models of the patient’s cranium. This allows surgeons to visualize the patient’s anatomy in great detail and plan the implantation procedure with precision. Additionally, the integration of artificial intelligence (AI) and machine learning algorithms into planning systems has further enhanced their capabilities. These algorithms can analyze vast amounts of patient data, including medical history, imaging scans, and surgical outcomes, to provide surgeons with valuable insights and recommendations for optimal implantation sites. This not only improves the accuracy of the procedure but also reduces the risk of complications and post-surgical revisions. The market for planning systems for cranial implantation is also benefiting from increased investments in research and development. Medical device manufacturers are constantly striving to develop more advanced and user-friendly systems that can streamline the planning process and improve patient outcomes. This has led to the introduction of innovative features, such as virtual reality simulations and augmented reality overlays, which allow surgeons to practice and visualize the procedure before the actual surgery. Furthermore, the growing awareness among healthcare professionals about the benefits of using planning systems for cranial implantation is driving market growth. Surgeons are increasingly recognizing the importance of precise device placement in achieving optimal treatment outcomes. As a result, the demand for planning systems is expected to rise significantly in the coming years. In conclusion, the market for systems for planning the implantation of a medical device mounted on the cranium is witnessing substantial growth due to the increasing prevalence of neurological disorders and advancements in medical technology. These systems play a critical role in ensuring accurate and precise device placement, ultimately improving patient outcomes. With ongoing research and development efforts, the market is expected to expand further, offering more advanced and efficient planning solutions for cranial implantation procedures.

The Medtronic Inc invention works as follows

The “devices, systems and methods” relate to the planning and guidance of a cranial-based implantation for an implantable medical devices or devices. Data is collected, for example, about the skull, scalp, vascular system, or neurological structures of a patient’s head. Images such as those generated by CT-scan, X-rays, and magnetic resonance imaging can be used to collect data. The data collected can be used by a surgeon to determine whether a patient is a good candidate for a cranial implant, whether their skull and scalp are able to support it, the configuration of the implant, the location and the incisions.

Background for System for planning the implantation of a medical device mounted on the cranium

Implantable Medical Devices (IMDs),” are devices that can be implanted in the body of a mammalian. These devices may sense medical parameters, monitor conditions, administer treatment, or any combination. IMDs are typically made up of a number of mechanical and/or electrical components. They may also include a housing to house the components. The housing protects the fragile components against forces that they might otherwise encounter when implanted in the body. Housings can be made from titanium. IMD housings tend to be hermetically sealed in order to prevent potentially harmful interactions with bodily fluids such as corrosion.

Large components that are common to all IMDs include a coil and a hybrid-circuit, which includes digital circuits (e.g. integrated circuit chips or microprocessors) and analog circuit components. IMDs can also include other components. “The components and housing both add bulk to the IMD.

Some medical devices can be implanted into the head of patients. An IMD, for example, may be implanted beneath the scalp, on top of the skull, and with one or several leads implanted on the brain or in the head.

In general the disclosure is aimed at techniques for planning and implementing implantation of an IMD which is ultimately attached to a part of the skull of a person. The implantation of an IMD cranially placed may involve making a small incision on the scalp to gain access to the site of implantation, then implanting the IMD. The IMD can be implanted by attaching it to the skull using adhesive or fasteners. It may also be attached to the outside surface of the head or within a recess. Electrical leads including one or multiple electrodes that are electrically connected to circuitry in the IMD through electrical conductors contained within the lead(s) may extend from IMD to one or several openings of the skull. This allows the electrodes to be placed on a target tissue such as brain tissues located within the patient’s skull.

The devices, systems and techniques described here may improve the efficiency of implantation and increase the success rate. Data is generally collected before surgery to assist the surgeon with planning and executing surgery. The data collected can be related to different physical parameters (e.g. anatomical or structural) associated with the head of a patient receiving the implanted IMD. For example, data related to contours and thicknesses of various parts of the brain, condition of scalp, vascular and/or neurologic structures within the head, previous electrophysiological measurements and so on. Images, such as those generated by X rays, magnetic resonance imaging, computerized tomography, EEG measurements and fluoroscopy, can be used for the data. Data can be presented in physical or virtual models, such as a patient’s skull. The collected data may include additional data about the patient. For example, the medical history and other information, such a whether the patient is wearing glasses or hearing aids, and what types of activities he/she may be involved in. The data collected by the systems, devices and techniques described in this document may also include data related to various IMD devices and devices like electrical leads with electrodes which may be incorporated into an IMD system that is being considered for use as a cranially-mounted implant procedure.

The systems, devices and techniques described herein in some examples provide an interface that allows the user (such as a surgeon evaluating or performing the implantation for a patient) to graphically represent various scenarios related to the proposed implant based upon the collected data and, in some cases, based upon inputs such as threshold limitations and other parameters which may be entered into the system by the users, or via manufacturer data associated with the device.

The surgeon can also determine using the generated graphical images what devices may be best suited for an implant for the particular patient, where the device(s) may and/or cannot be implanted, how to optimize post-implant performance of the device as it monitors brain signals and delivers therapy, and how to make the surgical incisions required to perform the implantation of the device(s). The surgeon can determine using the generated graphics which devices are best suited to an implant in the patient’s skull and scalp, as well as where they may or may not be placed. They can also decide what devices would be most suitable for the implant, including the location of the implant.

The surgeon can also use the graphic interfaces described here to determine which configuration or devices (including what specific IMDs) should or could be implanted in a patient. The devices, systems and techniques described in this disclosure can also be used to model different levels of recessing the IMD into the skull of an individual patient, so that the surgical aspect and the cosmetic and physical aspects of the proposed implantation are taken into consideration.

The disclosure includes a method that comprises: receiving image data from a patient’s head at a processing device; receiving an indication of selected evaluation parameters at the processing device; rendering a graphic image including a skull-model based upon the image data; the skull-model comprising one of more image annotations superimposed on the skull-model, determined by an evaluation of the selected evaluation parameters. Displaying, on a display, the rendered graphic image comprising the model of the skull and the image annotations.

The disclosure also includes a system that comprises: a processing device configured to: receive images of a human head; receive an indication for one or several evaluation parameters; render a graphic image of a skull based upon the image data; the skull containing one or multiple image annotations overlaid onto the model; the image annotations being determined by an evaluation of the selected evaluation parameters. A display device is configured to receive and display the rendered image, which contains the skull and the superimposed image annotations.

The disclosure also includes instructions that cause processing circuitry to render a graphic image containing a skull-model based upon the image data. The skull-model comprises one or multiple image annotations superimposed on the skull-model, determined by an evaluation of the selected evaluation parameters.

The drawings and description below provide details about one or more examples. The description, drawings and claims will reveal other features, advantages and objects of the disclosure.

BRIEF DESCRIPTION DES DRAWINGS

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FIG. 3A shows an axial view of an image that is associated with the head portion of a person in accordance with various techniques described in this disclosure.

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FIG. “FIG. 5B shows a top and side view of an example implantable device that can be modeled to be implanted for a patient according to the techniques described in this disclosure.

FIG. FIG. 6 shows an example of a three-dimensional image that can be generated and displayed using the techniques described in this disclosure.

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