Transformable structures for therapy

Abstract

Devices, systems, and techniques are disclosed for delivering electrical stimulation therapy and / or sensing physiological signals via electrodes disposed on a deformable auxetic structure. For example, a system may include a structure including a pattern of repeating cells configured to transition the structure between a compact configuration and an expanded configuration. The structure may be substantially flat when in the compact configuration. The structure may define one or more three-dimensional profiles when in the expanded configuration. Each of the repeating cells may include a plurality of elements that have an increased distance between adjacent ones of the plurality of elements when in the expanded configuration compared to the compact configuration. One or more electrodes may be disposed on the structure.

Description

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 498,973, filed April 28, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0002] This disclosure relates to implantable systems for delivering electrical stimulation and / or sensing electrical signals. Background Technology

[0003] Implantable medical devices can be configured to deliver electrical stimulation therapy and / or monitor physiological signals. For example, electrical stimulation of nerve tissue can provide relief from a variety of disorders, thereby improving the quality of life for many patients. Some implantable medical devices may employ electrical leads carrying electrodes. For example, the electrodes may be positioned at the distal portion of the lead. The proximal portion of the lead may include electrical contacts coupled to the electrodes and to terminals within a housing of the implantable medical device, which may contain electronic circuitry, such as electrical stimulation generation circuitry and / or sensing circuitry. In some examples, multiple electrodes and multiple stimulation leads may be used to deliver electrical stimulation at multiple locations within the patient or to a target area. An example of electrical stimulation therapy includes alternating electric field (AEF) therapy or focused tumor therapeutic field (FTTF) therapy, an electric field therapy that uses low-intensity electric fields to treat brain tumors. Summary of the Invention

[0004] Generally, this disclosure describes devices, systems, and techniques related to delivering electrical stimulation to a target therapeutic area within a patient using electrodes and / or leads carried or disposed on a deformable elastomeric structure. The elastomeric structure and metamaterial architecture enable the fabrication of structures that define locations for electrode placement in two-dimensional or planar space or simpler geometries (e.g., when the structure is substantially flat and in a compact configuration), and for unfolding and / or expanding (e.g., in an expanded configuration) to define one or more three-dimensional contours. These three-dimensional contours may be predetermined and are determined to correspond to a portion of the patient's anatomy, such as from one or more imaging modalities (e.g., magnetic resonance imaging (MRI), computed tomography (CT), etc.).

[0005] In some examples, the elastotropic structure comprises multiple cells arranged in such a way (e.g., repeating cell patterns and / or repeating elastotropic cell patterns) that the overall structure is configured to transform from a collapsed configuration to an expanded configuration when stretched (e.g., under tension or strain). This unusual deformation can result in a negative Poisson's ratio and changes in mechanical properties. In some examples, these cells comprise multiple elements within the cell, and in the expanded configuration, there is an increased distance between adjacent elements among these multiple elements compared to a compact configuration.

[0006] In some examples, electrodes disposed on a deformable stretchable structure can be configured to deliver electric field therapy for various purposes, such as reducing or preventing the growth of tumor cells (e.g., glioblastoma) or reducing the growth or proliferation of non-tumor cells in the body. The electric field therapy may include modulated electric field therapy, which may include types of electric field modulation, such as alternating electric field (AEF) or focused tumor therapeutic field (FTTF) therapy. The electrodes may additionally or alternatively be configured to sense electrical signals from the patient.

[0007] In one example, a system includes: a structure comprising a pattern of repeating cells configured to transition between a compact configuration and an expanded configuration, wherein: the structure is substantially flat in the compact configuration, the structure defines one or more three-dimensional contours in the expanded configuration, and each cell in the repeating cells comprises a plurality of elements, wherein, in the expanded configuration, the plurality of elements have increased distances between adjacent elements among the plurality of elements; and one or more electrodes disposed on the structure.

[0008] In another example, a system includes: a bistable tumbling structure comprising a pattern of repeating tumbling cells configured to cause the bistable tumbling structure to switch between a compact configuration and an expanded configuration when tension is applied to the bistable tumbling structure, wherein: the bistable tumbling structure is substantially flat in the compact configuration, the bistable tumbling structure defines one or more three-dimensional contours in the expanded configuration, each tumbling cell of the pattern of repeating tumbling cells comprising a plurality of elements, the plurality of elements having an increased distance between adjacent elements in the expanded configuration compared to the compact configuration, the compact configuration being a first stable configuration, the expanded configuration being a second stable configuration, and the bistable structure being unstable in a configuration between the first stable configuration and the second stable configuration; and one or more electrodes disposed on the structure at one or more locations corresponding to predetermined target locations within a patient body for therapeutic delivery.

[0009] In another example, a method includes: generating a structure comprising a pattern of repeating cells configured to transition the structure between a compact configuration and an expanded configuration, wherein: the structure is substantially flat in the compact configuration, the structure defines one or more three-dimensional contours in the expanded configuration, and each cell in the repeating cells comprises a plurality of elements, wherein, in the expanded configuration, the plurality of elements have increased distances between adjacent elements among the plurality of elements compared to the compact configuration; and attaching one or more electrodes to the structure.

[0010] In another example, a method includes: transforming a convertible structure into an expanded configuration; inserting the convertible structure into a patient; receiving a request for delivery of therapy via processing circuitry; and delivering therapy via one or more electrodes disposed on the convertible structure, wherein: the structure includes a pattern of repeating cells configured to allow the structure to transition between a compact configuration and an expanded configuration, the structure being substantially flat in the compact configuration and defining one or more three-dimensional contours in the expanded configuration, and each cell in the repeating cells including a plurality of elements having increased distances between adjacent elements in the expanded configuration compared to the compact configuration; and one or more electrodes disposed on the structure.

[0011] Details of one or more examples of the technology disclosed herein are set forth in the accompanying drawings and the following description. Other features, objectives, and advantages of these technologies will be apparent from the specification, drawings, and claims. Attached Figure Description

[0012] Figure 1 This is a conceptual diagram illustrating an example system including an example transformable structure, wherein one or more electrodes are disposed on the structure.

[0013] Figure 2 Examples of techniques for delivering therapy according to this disclosure Figure 1 A block diagram of an example IMD.

[0014] Figure 3 Examples of delivery of controlled therapies based on the technology disclosed herein. Figure 1 A block diagram of the external programmer.

[0015] Figure 4 This is a conceptual diagram illustrating an example configuration of a transformable structure.

[0016] Figure 5 This is a conceptual diagram illustrating the example IMD and the example transformable structure's side sectional view.

[0017] Figure 6This is a conceptual diagram illustrating the example IMD and the example transformable structure's side sectional view.

[0018] Figure 7 This is a flowchart illustrating an example technology used to manufacture the example system.

[0019] Figure 8 This is a flowchart illustrating an example technique for implanting and / or inserting a transformable structure into a patient's body.

[0020] Throughout the specification and drawings, similar reference characters represent similar elements. Detailed Implementation

[0021] According to the technology disclosed herein, a system may include a convertible structure carrying one or more electrodes or one or more leads, wherein the electrodes are configured to deliver electrical stimulation therapy to a target location near the patient's brain when the convertible structure is implanted in the patient.

[0022] Electrodes can be placed in a patient's tissue to deliver electrical signals to the tissue. For example, leads can be inserted into the tissue, where the leads include several electrodes along the length of the leads. Such leads may be referred to as cylindrical leads carrying multiple ring electrodes. However, in some cases, the desired treatment or target tissue may benefit from an electric field provided at different locations within the tissue or around cavities within the tissue. Cylindrical leads may not be easily deployed and / or maintained to provide stimulation at these locations.

[0023] As described herein, tautological structures and metamaterial architectures enable the fabrication of structures that define locations for electrode placement in two-dimensional or planar space (e.g., when the structure is substantially flat and in a compact configuration), and for unfolding and / or expanding (e.g., in an expanded configuration) to define one or more three-dimensional contours. Electrodes can then be held on or attached to corresponding portions of the tautological structure and used for stimulation or sensing.

[0024] An expansion structure may include multiple cells arranged in such a way (e.g., repeating the pattern of the cells and / or repeating the pattern of the expansion cells) that the overall structure is configured to transform from a collapsed configuration to an expanded or unfolded configuration in response to directional forces (e.g., tensile or compressive forces). In other words, these expansion structures may be fabricated in a flat or two-dimensional (2D) space and then transformed from a flat, unexpanded, compact configuration to a three-dimensional (3D) unfolded or expanded configuration. In some examples, these cells include multiple elements within the cell, with increased distances between adjacent elements in the expanded configuration compared to the compact configuration. In some examples, cells of different sizes and building block geometries are combined in a compact configuration to achieve the desired 3D shape in the expanded configuration.

[0025] Although this disclosure relates to structures implanted near a patient's brain for delivering AEF or FTTF therapy to treat glioblastoma, the systems, devices, and techniques described herein can similarly operate to deliver AEF or FTTF therapy or similar electric field therapy to other tissue areas and / or treat different types of cancer. For example, systems can be implanted to treat and / or prevent cancer in the spine, pelvis, abdomen, or any other location. Some examples of target tissue may include areas of anticipated metastatic elements (such as lymph nodes) to reduce the spread of cells from different tumor sites. The structures described herein can be used in applications delivering therapy to areas with complex anatomical geometries. In other examples, electrodes carried by the transformable structure can be configured to sense signals or deliver electrical stimulation for other purposes, such as pain treatment or deep brain stimulation therapy to modulate neural function in the brain or any other location in the body. Furthermore, while human patients are described herein for illustrative purposes, similar systems, devices, and techniques can be used in other animals in other examples.

[0026] Figure 1 This is a conceptual diagram illustrating an example system 100 including an implantable medical device (IMD) 106 configured to deliver a therapy to a patient 112, according to an example of the technology according to this disclosure. The therapy may be an AEF or FTTF therapy or another therapy based on an applied electric field. Figure 1 As illustrated, example system 100 includes a medical device programmer 104, an implantable medical device (IMD) 106, a lead extension 110, a lead 114, and electrodes 116A, 116B, and 116C (collectively referred to below as “electrode 116,” a plurality of electrodes 116, an electrode array 116, or one or more electrodes 116). Electrodes 116 and / or leads 114 may be disposed on, carried by, or otherwise attached to a structure 130, which may be a deployable stretchable structure. Figure 1In the examples shown, electrode 116 is positioned to deliver electrical stimulation to tissue sites within brain 120, such as deep brain sites beneath the dura mater of brain 120 in patient 112. In some examples, an electric field (e.g., electrical stimulation) is delivered to one or more regions of brain 120, such as regions containing tumors (e.g., glioblastoma) or regions where glioblastoma has been resected (removed). In examples of resection cavities where tumors are removed, cavities within, for example, tumor beds can be target tissue or part of the tissue for AEF or FTTF therapy. Tumor beds can have various sizes, but in some examples, the diameter can be between approximately 1 mm and 3 mm. Some or all of the electrodes in electrode 116 may also be positioned to sense neurobrain signals within brain 120 in patient 112. In some examples, some electrodes in electrode 116 may be configured to sense neurobrain signals, impedance, etc., and some or all of the electrodes in electrode 116 may be configured to deliver electrical stimulation to brain 120 in the form of AEF or FTTF therapy. In other examples, all electrodes in electrode 116 are configured to simultaneously sense electrical signals and deliver electrical stimulation to brain 120.

[0027] IMD 106 includes a therapy module (e.g., which may include processing circuitry, signal generation circuitry, or other circuitry configured to perform functions attributed to IMD 106), the therapy module including a stimulation generator configured to generate electrical stimulation therapy (e.g., AEF or FTTF therapy) via a subset of electrodes 116 (e.g., less than all electrodes) and deliver the electrical stimulation therapy to patient 112. The subset of electrodes 116 used to deliver electrical stimulation to patient 112, and in some cases, the polarity of the subset of electrodes 116, may be referred to as a stimulating electrode combination. As described in further detail below, the stimulating electrode combination can be selected for a specific patient 112 and target tissue site (e.g., based on the patient's condition or based on a determined location of a tumor or other tissue of interest). The group of electrodes 116 includes at least one electrode and may include more than one electrode. Furthermore, although... Figure 1 Examples include a single lead (e.g., lead 114), but more than one lead may be used. Electrode 116 may be part of structure 130, or an electrode may be coupled to structure 130. In some examples, electrode 116 is defined by structure 130 in which a portion of insulating material is removed (e.g., using ablation) to define an area of ​​conductive material. In this way, electrode 116 is defined by a corresponding portion of structure 130, such as where insulating material is removed to expose conductive material. In other examples, electrode 116 is individually attached to or coupled to structure 130 at one or more fixed points.

[0028] In some examples, multiple electrodes 116 are positioned on structure 130 to generate different electric fields. For example, the electrode may operate as an anode at a first location on structure 130, and a cathode at a second location on structure 130 may be used to generate the first electric field. The second electric field may be generated using the electrode configured near the cathode at the first location on structure 130 and near the anode at the second location on structure 130. Thus, alternating between the first and second electric fields can generate currents that change the polarity of cellular components to disrupt cell division. Although in Figure 1 The example shows a single structure 130, but in different examples, two, three, four, five, or more structures may be used. In any case, the combination of structures provides an overall array of electrodes that can be programmed to deliver alternating electric fields to target tissue. These complex electrode geometries also enable directional sensing of the orientation of the electric field generated in the tissue. For example, the system can measure the potential between electrodes or between different leads / structures at different locations on the lead / structure to determine the gradient of the potential and the gradient of the delivered electric field. The system can then determine the electric field spread and configure a predictive model of the electric field and / or calibrate the field spread based on the sensed potential gradient.

[0029] In some examples, neural signals sensed within brain 120 (e.g., exemplary types of electrical signals) may reflect changes in current generated by the sum of potential differences throughout the brain tissue. Examples of neural brain signals include, but are not limited to, electrical signals generated based on local field potentials (LFP) sensed in one or more regions of brain 120, electroencephalogram (EEG) signals, or electrocorticograph (ECoG) signals. Any of these sensed signals may be endogenous signals generated by physiological neural activity and / or evoked signals generated in response to delivered stimuli (e.g., delivered electrical stimulation signals). It should be noted that modulated electric field therapy (e.g., AEF or FTTF therapy) may not induce neuronal propagation or affect other normal neural functions. However, the system may deliver signals designed to influence neural processes in order to sense signals that may indicate a physiological state or a response to modulated electric field therapy. In some examples, the system may utilize any combination of electrodes to directly sense electric fields (e.g., field strength, field location, or other properties) delivered by other electrode combinations. In this way, the system can confirm the expected electric field strength, adjust one or more stimulation parameters of the defined electric field to affect the target tissue (e.g., to match the desired stimulation model), and / or adjust the stimulation model to reflect the realism of tissue properties. In some examples, the system can adjust the stimulation parameters of the defined electric field to accommodate changes in tissue and / or lead / structure movement over time in a patient after surgery or over time. The system can adjust any of these parameters in real time in response to reviewing previously stored data and / or upon receiving or generating sensed data.

[0030] In some examples, neurobrain signals for selecting a combination of stimulation electrodes can be sensed within the same region of the target tissue site for electrical stimulation and / or from regions different from the target tissue site (e.g., adjacent to or outside the target tissue site) in the brain 120. The system can be configured to calculate or predict the electric field at the target tissue based on signals sensed within and / or in regions different from the target tissue. Specific target tissue sites and / or regions within the brain 120 can be selected based on the location, size, depth, and / or volume of the patient's condition or tumor bed or resection bed. Therefore, due to these differences in target location, in some examples, the electrodes used to deliver electrical stimulation may differ from the electrodes used to sense neurobrain signals. In other examples, the same electrodes can be used for both delivering electrical stimulation and sensing brain signals. However, this configuration using the same electrodes may require the system to switch between stimulation generation and sensing circuitry and may reduce the time the system can sense brain signals. In some examples, the system can be configured to deliver electrical signals to generate an electric field from the same electrode configuration (or using at least some of the same electrodes) on an at least partially interleaved basis.

[0031] The electrical stimulation generated by the IMD 106 can be configured to manage various disorders and conditions. In some examples, the stimulation generator of the IMD 106 is configured to generate electrical stimulation pulses for AEF or FTTF therapy via electrodes of a selected combination of stimulation electrodes and deliver such electrical stimulation pulses to the patient 112. However, in other examples, the stimulation generator of the IMD 106 can be configured to generate and deliver continuous wave signals, such as sine or triangular waves of specified amplitude (peak-to-peak) and frequency as part of the electric field of the AEF or FTTF therapy. Generally, modulated electric field therapy (e.g., AEF or FTTF therapy) may include the delivery of continuous wave signals, but the waveform can be symmetrical, asymmetrical, discontinuous, continuous, cyclic, interleaved between different combinations, constant, or otherwise varying over time in a random or predetermined sequence. In any case, the stimulation generator within the IMD 106 can generate AEF or FTTF therapy according to a therapy procedure selected at a given time of the therapy. In an example where the IMD 106 delivers electrical stimulation in the form of stimulation pulses, the therapeutic procedure may include a set of therapeutic parameter values ​​(e.g., stimulation parameters), such as the combination of stimulation electrodes for delivering different electric fields to the patient 112, pulse frequency, pulse width, and the current or voltage amplitude or continuous signal of the pulse. As previously noted, the electrode combination may indicate a specific electrode 116 selected for delivering the stimulation signal to the tissue of the patient 112, and the corresponding polarity of the selected electrode. The IMD 106 may deliver electrical stimulation intended to contribute to therapeutic efficacy. In some examples, the IMD 106 may also or alternatively deliver electrical stimulation intended to be sensed by other electrodes and / or elicit physiological responses that can be sensed by electrodes, such as induced compound action potentials (ECAPs).

[0032] The IMD 106 may be implanted in a subcutaneous pouch above the clavicle, or alternatively, implanted above or within the skull 122, or at any other suitable site within the patient 112, such as the lower abdomen or high hip. Other configurations may include implantation of the IMD 106 at multiple locations, such as near the site of tumor occurrence and at remote sites of possible tumor spread or diffusion. Generally, the IMD 106 is constructed of a biocompatible material resistant to corrosion and degradation by bodily fluids. The IMD 106 may include an airtight shell to substantially encapsulate components such as processors, therapy modules, and memory. Other implantation sites for the IMD 106 may be used to treat brain tissue or other tissues. Example alternative implantation sites for the IMD 106 may include the lower back, shoulder, neck, abdomen, or any other location.

[0033] like Figure 1 As shown, the implanted lead extension 110 is coupled to the IMD 106 via a connector 108 (also referred to as the connector block or connector of the IMD 106). Figure 1In one example, the lead extension 110 extends from the implantation site of the IMD 106 and crosses along the neck of the patient 112 to the skull 122 of the patient 112 to enter the brain 120. In some examples, one or more structures (such as structure 130) are implanted in the right and left hemispheres of the patient 112 to deliver AEF or FTTF therapy to one or more regions of the brain 120, which may be selected based on the patient's condition or impairment controlled by the therapy system 100. However, specific target tissue sites and stimulating electrodes for delivering stimulation to those target tissue sites may be selected, for example, based on the location of the tumor bed or resection bed and / or other sensed patient parameters. Other implantation sites for the lead 114, structure 130, and IMD 106 are envisioned. In some examples, the IMD 106 is implanted on or within the skull 122. Structure 130 may be implanted within one hemisphere or across both hemispheres.

[0034] Structure 130 can be positioned to deliver electrical stimulation to one or more target tissue sites within brain 120 (e.g., as an electrode array). One or more structures in structure 130 can position electrodes 116 at desired locations within brain 120 via corresponding holes or common openings in skull 122. Structure 130 can be placed anywhere within brain 120 such that electrodes 116 can deliver electrical stimulation to target tissue sites within brain 120 during treatment. For example, electrodes 116 of structure 130 can be surgically implanted beneath the dura mater of brain 120 or within the cerebral cortex of brain 120 via a drilled hole in skull 122 of patient 112, and electrically coupled to IMD 106 via lead 114.

[0035] Thus, structure 130 can be designed to be surgically placed within a tumor cavity or tumor bed to deliver an electric field via an electrode array, thereby covering the internal volume of the reduced cavity. In some examples, structure 130 is configured to expand to fill the volume and deploy electrode 116 (e.g., structure 130 may utilize pressure to hold electrode 116 in a target position). The expansion of structure 130 may occur within the patient 112 (e.g., within skull 122), or the expansion of structure 130 may occur outside the patient 112. The placement of electrode 116 on structure 130 may define a particular electrode array, but may not otherwise be specific to a particular tumor cavity of the patient. However, in some examples, structure 130 is specifically manufactured for a particular tumor cavity of the patient. Because each patient may have a unique geometry of the resected tumor cavity, structure 130 can be configured in a way that fits the patient's unique geometry, and the placement of electrode 116 can also be customized according to the patient's unique geometry. In some examples, structure 130 is configured to be implanted into and remain implanted within the patient. However, in some examples, electrode 116 may detach from structure 130, and structure 130 does not remain implanted, while electrode 116 remains in the tissue. In examples where electrode 116 detaches from structure 130, structure 130 may assist in the delivery and placement of electrode 116.

[0036] In some examples, more than one of the structures in structure 130 may be implanted into a patient. For example, in cases where a patient has multiple tumor cavities or tumor beds, one or more structures in structure 130 may be placed in each of the multiple tumor cavities or tumor beds. In some examples, more than one structure in structure 130 may be placed in a single tumor cavity or tumor bed, depending on the shape, size, orientation, and the need for stimulation therapy. In cases where more than one structure in structure 130 is implanted into a patient, each structure in structure 130 may be customized to fit the specific shape, size, and orientation of each tumor cavity or tumor bed.

[0037] exist Figure 1 In the example shown, IMD 106 includes a memory for storing multiple therapeutic procedures, each defining a set of therapeutic parameter values. In some examples, IMD 106 can select a therapeutic procedure from the memory based on various parameters, such as sensed patient parameters and identified patient behavior. IMD 106 can generate electrical stimulation based on the selected therapeutic procedure to deliver an effective AEF or FTTF therapy that reduces or prevents cancer cell division or other cellular functions.

[0038] External programmer 104 wirelessly communicates with IMD 106 as needed to provide or retrieve therapy information. Programmer 104 is an external computing device that a user (e.g., a clinician and / or patient 112) can use to communicate with IMD 106. For example, programmer 104 could be a clinician programmer, which the clinician uses to communicate with IMD 106 and program one or more therapy procedures for IMD 106. Alternatively, programmer 104 could be a patient programmer, which allows patient 112 to select programs and / or view and modify therapy parameters. Clinician programmers may include more programming features than patient programmers. In other words, only clinician programmers may allow for more complex or sensitive tasks to prevent untrained patients from making unintended changes to IMD 106. IMD 106 may also transmit notifications to programmer 104 for delivery to the user in response to the detection of one or more questions about stimuli and / or the detection of one or more triggering events of patient 112. Programmer 104 can input a new programming session for the user to select new stimulation parameters for subsequent therapy. External programmer 104 can display the estimated location of the target tissue and / or suggested stimulation parameter values ​​for delivering electrical stimulation affecting the target tissue location.

[0039] When programmer 104 is configured for use by a clinician, it can be used to transmit initial programming information to IMD 106. This initial information may include hardware information such as the type of lead 114 and electrode arrangement on structure 130, the location of structure 130 and / or lead 114 within brain 120, the configuration of electrode array 116 on structure 130, an initial procedure defining therapeutic parameter values, and any other information the clinician expects to program into IMD 106. Programmer 104 may also be able to perform functional tests (e.g., measuring the impedance of electrode 116 or the electric field strength at key locations on structure 130). In some examples, programmer 104 may receive sensed signals or representative information and perform the same techniques and functions as those attributed to IMD 106 herein. In other examples, a remote server (e.g., a standalone server or part of a cloud service) may perform the functions attributed to IMD 106, programmer 104, or any other device described herein.

[0040] Programmer 104 can also be configured for use by patient 112. When configured as a patient programmer, programmer 104 may have limited functionality (compared to a clinician programmer) to prevent patient 112 from altering critical functions of IMD 106 or from using applications that may be harmful to patient 112. Thus, programmer 104 may only allow patient 112 to adjust the values ​​of certain therapy parameters or set the available range of values ​​for specific therapy parameters. In one example, the patient programmer may only allow functions such as turning AEF or FTTF therapy on or off and / or reducing stimulation intensity. In some examples, programmer 104 may present indications of patient delivery times, such as a screen indicating the amount of time for therapy delivery per day, week, month, etc., and / or the time when therapy has been turned off. For example, programmer 104 may present "Therapy has been delivered for 85% of the time in the past week" or "Therapy has been delivered for 6 days in the past 7 days." Furthermore, when IMD 106 operates using a rechargeable power supply, programmer 104 may present the remaining available therapy time before recharging is required.

[0041] The programmer 104 can also provide indications to the patient 112 when therapy is being delivered, when patient input triggers a therapy change, or when the power supply within the programmer 104 or IMD 106 needs to be replaced or recharged. For example, the programmer 104 may include alarm LEDs that can send messages to the patient 112 via the programmer display, generate audible or haptic prompts to confirm receipt of patient input, such as to indicate patient status or to manually modify therapy parameters.

[0042] The therapy system 100 can be implemented to provide chronic stimulation therapy to patient 112 over a period of months or years. However, system 100 can also be used on a trial basis to evaluate the therapy before full implantation. If implemented intermittently, some components of system 100 may not be implanted in patient 112. For example, patient 112 may be fitted with an external medical device, such as a trial stimulator, instead of IMD 106. The external medical device may be coupled to a percutaneous lead or implanted lead via a percutaneous extension. If the trial stimulator instructs AEF or FTTF system 100 to provide effective treatment to patient 112, the clinician may implant a chronic stimulator in patient 112 for relatively long-term treatment using AEF or FTTF therapy.

[0043] While IMD 106 is described as delivering electrical stimulation therapy to brain 120, in other examples, IMD 106 may be configured to direct electrical stimulation to other anatomical regions of patient 112. In other examples, system 100 may include an implantable drug pump in addition to or instead of IMD 106. Furthermore, the IMD may provide other electrical stimulation (such as spinal cord stimulation) to treat other types of cancer or other diseases or disorders. In some embodiments, the therapy delivered by IMD 106 is designed to enhance the ability of a specific drug to cross the blood-brain barrier, or is designed to enable a specific drug to cross the blood-brain barrier. In other embodiments, the therapy delivered by IMD 106 is designed to enhance and / or achieve cell membrane permeability for the purpose of mediating cell transfection or enhancing viral delivery to target cells. By being designed to achieve these goals, IMD 106 may be configured to deliver electric field therapy (via specific stimulation parameter values) that increases blood-brain barrier permeability and / or enhances cell membrane permeability.

[0044] According to the technology disclosed herein, system 100 may include processing circuitry configured to: receive a request for delivery of alternating electric field (AEF) or focused tumor therapeutic field (FTTF) therapy; determine therapeutic parameter values ​​defining the AEF or FTTF therapy, wherein the AEF or FTTF therapy includes delivery of a first electric field and a second electric field; control IMD 106 to deliver the first electric field from a first electrode assembly of implanted electrodes; and control IMD 106 to alternately deliver the second electric field from a second electrode assembly of implanted electrodes different from the first electrode assembly. The request may be initiated via user input and / or an automated system request to begin AEF or FTTF therapy delivery.

[0045] The electric field generated by the IMD 106 alternating over time to produce AEF or FTTF therapy may involve different electrode combinations and / or different methods for alternating the electric field between different electrode combinations (e.g., different electrodes and / or different polarities of the same or different electrodes). In one example, a first electrode combination includes a first set of electrodes defined as a cathode and a second set of electrodes defined as an anode, and a second electrode combination includes a first set of electrodes defined as an anode and a second set of electrodes defined as a cathode.

[0046] IMD 106 typically uses the same pulse or signal frequency to generate the electric field for AEF or FTTF therapy. In one example, the frequency could be approximately 150 kHz. In another example, the frequency could be approximately 200 kHz. Generally, the frequency can be selected from a range of approximately 100 kHz to 300 kHz, but frequencies higher or lower than this range may be used in other examples. In some examples, the frequency used by IMD 106 is selected based on the type of cells targeted for therapy. For example, if the target cancer cells are of a certain size (e.g., 13 micrometers in diameter), IMD 106 delivers the therapy at a frequency (e.g., 200 kHz) at which the therapy would be more effective for that cell size. In some examples, the frequency or frequency range for delivering the electric field may be selected based on the results of a patient biopsy or based on a lookup table of associated distributions according to tumor type and cell size. In some examples, a minimum or maximum frequency may be selected to avoid affecting the size of healthy cells within the electric field, which may differ in size from the tumor cells.

[0047] The IMD 106 can alternate electric fields in AEF or FTTF therapy by delivering electric fields from different electrodes and / or electrodes with different polarities. In one example, the IMD 106 can continuously shift the polarity of the electrodes in one direction relative to the electrode array. A first electrode assembly may include a first set of electrodes defined as cathodes and a second set of electrodes defined as anodes, and a second electrode assembly may include a third set of electrodes defined as anodes and a fourth set of electrodes defined as cathodes.

[0048] like Figure 1As shown, electrodes 116 (e.g., at least two electrodes) for delivering AEF or FTTF therapy are positioned on a structure 130 adjacent to a tissue resection bed. In some examples, at least two of the implanted electrodes 116 for delivering AEF or FTTF therapy are subcutaneous electrodes (e.g., electrodes implanted under the skin and on the bone surface). In some examples, one or more electrodes may be implanted within a removed portion of the skull during surgery to provide relatively easy electrode implantation within the skull but outside the brain. In other examples, the system may use a combination of multiple external skin electrodes with multiple implanted electrodes 116 to deliver AEF or FTTF therapy. For example, a first electric field for AEF or FTTF therapy may be delivered between two or more external electrodes, and a second electric field for AEF or FTTF therapy may be delivered between two or more implanted electrodes 116. In other examples, the two or more electric fields generating AEF or FTTF therapy each utilize one or more external electrodes. In some examples, current flows only between external electrodes or only between implanted electrodes. In other examples, one or more electric fields may be generated between any combination of external electrodes and implanted electrodes 116. An external device can deliver current to the external electrodes, or control them independently or based on communication between the external device and the IMD 106.

[0049] Generally, AEF or FTTF therapy is described herein as treatment for pre-existing tumors, such as glioblastoma. In other examples, the application of AEF or FTTF therapy can reduce the extent of metastatic tumor burden and dissemination of tumors from distant tumor sources. Therefore, AEF or FTTF therapy can be delivered to protect tissue regions from metastatic spread. For example, AEF or FTTF can be used to provide whole-brain protection in the presence of known malignancies in vivo, particularly those malignancies with a tendency to spread to the brain (e.g., melanoma). AEF or FTTF can be delivered to prevent further metastatic spread of tumors within organ systems currently exhibiting metastatic dissemination. Furthermore, AEF or FTTF implantation plans can be provided to protect certain neurological functions (e.g., motor function), such that the implantation system 100 will focus treatment on the precentral gyrus and / or corticospinal tract to maintain its function and prevent dissemination.

[0050] AEF or FTTF-delivered implants (e.g., IMD 106, lead 114, and structure 130) can be used for prophylactic treatment of body areas anticipated to have a high risk of metastatic dissemination (e.g., a presumed location where the tumor will subsequently develop). An example is the axillary lymph nodes in the case of newly diagnosed breast cancer. Lymphatic pathways have predictable flow and are common pathways for metastatic dissemination. Therefore, implantation strategies that focus systemic therapy on these pathways can meaningfully influence the predisposition and capacity for tumor metastasis.

[0051] AEF or FTTF delivery can also utilize intra-arterial electrodes to allow for broader control of metastatic spread. In other words, AEF or FTTF delivery reduces the likelihood of metastatic tumor cells leaving the bloodstream and spreading to other areas of the body. In one example, treatment of the carotid artery can reduce the ability of tumor cells to leave the bloodstream and invade brain tissue. Intra-arterial AEF or FTTF delivery can provide favorable pharmacokinetic effects on the drug within the tumor region, and thus justifies the intra-arterial placement of electrodes for AEF or FTTF delivery. Thus, the AEF or FTTF therapy described herein can be applied to many different tissues and for many different reasons. For example, AEF or FTTF therapy or other modulated electric field therapies can be provided as a prophylactic treatment to tissues that have not yet been diagnosed with cancer but are at risk of developing tumors, based on one or more characteristics such as genetic markers, environmental factors, or any other risk factors.

[0052] Figure 1 The architecture of the illustrated system 100 is shown as an example. The techniques described in this disclosure can be applied to... Figure 1 The example system 100 and other types of systems not specifically described herein are implemented. Nothing in this disclosure should be construed as limiting the technology of this disclosure to... Figure 1 The example architecture is shown.

[0053] System 100 is generally described as including IMD 106 and external programmer 104. However, in other examples, the external medical device may be configured to perform any of the techniques described herein or with respect to IMD 106. The external medical device may be coupled to a percutaneous lead or other device that passes through the skin to place implanted electrodes at various locations within the patient's body to at least partially deliver electric field therapy and / or sensing signals as described herein. Additionally or alternatively, the external device may be coupled to external electrodes configured to at least partially deliver electric field therapy and / or sensing signals as described herein. The external medical device may be configured to communicate with programmer 104 and / or partially or fully integrate with the structure to perform various functionalities described with respect to programmer 104.

[0054] Figure 2 Examples of techniques for delivering therapy according to this disclosure Figure 1 A block diagram of an example IMD. Figure 2In the example shown, IMD 106 includes processing circuitry 210, memory 211, stimulation circuitry 202, sensing module 204, switching module 206, telemetry module 208, sensor 212, and power supply 220. In some examples, any or all of the processing circuitry 210, memory 211, stimulation circuitry 202, sensing module 204, switching module 206, telemetry module 208, sensor 212, and power supply 220 are included in structure 130, and structure 130 can be configured to perform any of the functions of the IMD 106 described herein. Each of these modules may be or includes circuitry configured to perform the functions attributed to each respective module. For example, processing circuitry 210 may include processing circuitry, switching module 206 may include switching circuitry, sensing module 204 may include sensing circuitry, and telemetry module 208 may include telemetry circuitry. Switching module 206 may not be used in a configuration of multiple current sources and current sinks, but in such a configuration, one or more switches can still be used to disconnect sensing module 204 from the sources and sinks. Memory 211 may include any volatile or non-volatile medium, such as random access memory (RAM), read-only memory (ROM), non-volatile RAM (NVRAM), electrically erasable programmable ROM (EEPROM), and flash memory. Memory 211 may store computer-readable instructions that, when executed by processing circuitry 210, cause IMD 106 to perform various functions. Memory 211 may be a storage device or other non-transitory medium.

[0055] exist Figure 2 In the example shown, memory 211 stores therapy programs 214, which include a corresponding set of stimulation parameters defining AEF or FTTF therapy. Each stored therapy program 214 defines a specific set of electrical stimulation parameters (e.g., a set of therapy parameters), such as combinations of stimulating electrodes, electrode polarity, current or voltage amplitude, pulse width, and pulse frequency. In some examples, individual therapy programs may be stored as therapy groups, which define a set of therapy programs that can be used to generate stimulation.

[0056] The memory 211 may also include parameter selection instructions 217 and notification instructions 218. Parameter selection instructions 217 may include instructions for controlling the processing circuitry 210 to select different stimulation parameter values, such as electrode combinations, amplitude, pulse frequency, or other parameter values ​​related to various locations of the target tissue or changes in patient condition or tissue state. Parameter selection instructions 217 may include instructions for the processing circuitry 210 to select parameter values ​​based on various feedback variables. Notification instructions 218 may define instructions for controlling the processing circuitry 210 to perform actions such as transmitting alarms or other notifications to external devices (such as programmer 104) indicating whether therapy has been turned on or off, or whether changes to AEF or FTTF therapy have been made or are recommended.

[0057] In some examples, the sensing and stimulating electrode combinations may include the same subset of electrodes 116, the housing of the IMD 106 used as electrodes, or different subsets or combinations of such electrodes. Therefore, memory 211 may store multiple sensing electrode combinations, and for each sensing electrode combination, store information identifying the stimulating electrode combination associated with the corresponding sensing electrode combination. The association between the sensing and stimulating electrode combinations may be determined, for example, by a clinician or automatically by processing circuitry 210. In some examples, the corresponding sensing electrode combination and stimulating electrode combination may include some or all of the same electrodes. However, in other examples, some or all of the electrodes in the corresponding sensing electrode combination and stimulating electrode combination may be different. For example, the stimulating electrode combination may include more electrodes than the corresponding sensing electrode combination to enhance the efficacy of AEF or FTTF therapy.

[0058] Under the control of processing circuitry 210, stimulation circuitry 202 generates stimulation signals for delivery to patient 112 via a selected combination of electrodes 116. Examples of electrical stimulation parameters considered effective in managing cellular activity in AEF or FTTF therapy include:

[0059] 1. Frequency (e.g., waveform frequency or pulse rate): between approximately 50 kHz and approximately 500 kHz, such as between approximately 100 kHz and 300 kHz, or such as approximately 150 kHz or 200 kHz.

[0060] 2. In the case of a voltage control system, the voltage amplitude is between approximately 0.1 volts and approximately 50 volts, such as between approximately 2 volts and approximately 10 volts.

[0061] 3. In alternative current control systems, the current amplitude is between approximately 0.2 mA and approximately 100 mA, such as between approximately 1.3 mA and approximately 2.0 mA.

[0062] 4. Pulse width: between approximately 1 microsecond and approximately 10 microseconds, such as between approximately 1 microsecond and approximately 5 microseconds, or between approximately 2 microseconds and approximately 10 microseconds.

[0063] 5. Cycle time (e.g., communication time): This is the time the waveform remains consistent before disconnecting or switching to a new waveform. Cycle time can be selected from a range of 30 seconds to 30 minutes, or from 1 minute to 10 minutes. In other examples, shorter and longer cycle times can be used.

[0064] Therefore, in some examples, the stimulation circuit 202 generates an electrical stimulation signal according to the electrical stimulation parameters described above. Other ranges of therapeutic parameter values ​​may also be useful and may depend on the target stimulation site within the patient 112. Although stimulation pulses are described, the stimulation signal can be of any form, such as a continuous-time signal (e.g., a sine wave). The stimulation signal or other evoked physiological signal configured to trigger ECAP may be similar to or different from the range of parameter values ​​described above. Furthermore, the sensing circuit 204 may be configured to sense signals via one or more combinations of electrodes on one or more leads 114 (e.g., the same or different electrodes may deliver stimulation and sense electrical signals).

[0065] Processing circuitry 210 may include fixed-function processing circuitry and / or programmable processing circuitry, and may include one or more of the following: a microprocessor, a controller, a digital signal processor (DSP), an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA), discrete logic circuitry, or any other processing circuitry configured to provide the functions attributed to processing circuitry 210, which may herein be embodied as firmware, hardware, software, or any combination thereof. Processing circuitry 210 may control stimulation circuitry 202 to specific stimulation parameter values, such as voltage or current amplitude, pulse width, or pulse rate, as specified by one or more programs in the application, according to therapeutic program 214 stored in memory 211.

[0066] exist Figure 2In the example shown, the set of electrodes 116 includes electrodes 116A, 116B, and 116C. Processing circuitry 210 also controls switching module 206 to apply the stimulation signal generated by stimulation circuitry 202 to a selected combination of electrodes 116. Specifically, switching module 206 may couple the stimulation signal to a selected conductor within lead 114 or structure 130, which in turn delivers the stimulation signal across the selected electrodes 116. Switching module 206 may be a switch array, switch matrix, multiplexer, or any other type of switching module configured to selectively couple stimulation energy to the selected electrodes 116 and selectively sense neural brain signals using the selected electrodes 116. Thus, stimulation circuitry 202 is coupled to electrodes 116 via switching module 206 and conductors within lead 114 and / or structure 130. However, in some examples, IMD 106 does not include switching module 206, such as if each electrode is assigned a corresponding current and slot (e.g., an independent current source).

[0067] Stimulation circuit 202 can be a single-channel or multi-channel stimulation generator. Specifically, stimulation circuit 202 can be capable of delivering a single stimulation pulse, multiple stimulation pulses, or a continuous signal at a given time via a single electrode combination, or multiple stimulation pulses at a given time via multiple electrode combinations. However, in some examples, stimulation circuit 202 and switching module 206 can be configured to deliver multiple channels on a time-interleaved basis. For example, switching module 206 can be used to time-divide the output of stimulation circuit 202 across different electrode combinations at different times to deliver multiple programs or channels of stimulation energy to patient 112 (e.g., cycling between stimulation protocols in a fixed or variable order). Alternatively, stimulation circuit 202 may include multiple voltage or current sources and voltage or current tanks coupled to the respective electrodes to drive the electrodes as cathodes or anodes. In this example, IMD 106 may not require the functionality of switching module 206 to time-interleaved multiplexing of stimulation via different electrodes.

[0068] Despite Figure 2The sensing module 204 is integrated into a common housing along with the stimulation circuitry 202 and the processing circuitry 210. However, in other examples, the sensing module 204 may be housed in a separate housing from the IMD 106 and may communicate with the processing circuitry 210 via wired or wireless communication technologies. Example neurobrain signals include, but are not limited to, signals generated by local field potentials (LFPs) in one or more regions of the brain 120. EEG and ECoG signals are examples of other types of electrical signals that can be measured within the brain 120. Other examples include sensed signals representing electric field or voltage gradients induced by remote electrodes recorded by proximal electrodes or electrode pairs. Instead of LFPs or other methods, the IMD 106 may be configured to detect patterns of single-cell and / or multi-cell activity. The IMD 106 may sample this activity at rates above 1,000 Hz, and in some examples, it may sample the activity in a frequency range from 6,000 Hz to 500,000 Hz. The IMD 106 may identify the waveform of a single cell and / or may be an envelope of cell modulation used to distinguish or sort the characteristics of electrodes. In some examples, the technique may include phase amplitude coupled to the envelope or coupled to a specific frequency band in the LFP sensed from the same or different electrodes. In some examples, the sampling technique may be configured to identify the electric field strength at any location. For example, IMD 106 may include a peak follower circuit that maintains the amplitude of the field at a specific frequency for later sampling. Alternatively, the response of the resonant circuit may be tuned to an AEF or FTTF frequency, which may be sampled to infer the field strength of the desired signal.

[0069] Sensor 212 may include one or more sensing elements that sense values ​​of corresponding patient parameters, such as patient activity (e.g., movement and / or sleep). For example, sensor 212 may include one or more accelerometers, optical sensors, chemical sensors, temperature sensors, pressure sensors, or any other type of sensor. Sensor 212 may output patient parameter values ​​that can be used as feedback to control the delivery of AEF or FTTF therapy. IMD 106 may include additional sensors within the housing of IMD 106 and / or coupled via lead 114 or structure 130. Furthermore, IMD 106 may wirelessly receive sensor signals from remote sensors, for example, via telemetry module 208. In some examples, one or more of these remote sensors may be located outside the patient's body (e.g., carried on an external surface of the skin, attached to clothing, or otherwise positioned outside the patient's body).

[0070] Telemetry module 208, under the control of processing circuitry 210, supports wireless communication between IMD 106 and external programmer 104 or another computing device. As a program update, processing circuitry 210 of IMD 106 can receive values ​​of various stimulation parameters (such as amplitude and electrode combinations) from programmer 104 via telemetry module 208. Updates to the therapy program can be stored in the therapy program 214 portion of memory 211. Furthermore, processing circuitry 210 can control telemetry module 208 to transmit alarms or other information indicating lead movement relative to tissue to programmer 104. Telemetry module 208 in IMD 106, as well as telemetry modules in other devices and systems described herein (such as programmer 104), can communicate via radio frequency (RF) communication technology. Additionally, telemetry module 208 can communicate with external medical device programmer 104 via proximal sensor interaction between IMD 106 and programmer 104. Therefore, the telemetry module 208 can continuously send information to the external programmer 104 at periodic intervals or upon request from the IMD 106 or the programmer 104.

[0071] Power source 220 delivers operating power to the various components of IMD 106. Power source 220 may include a small rechargeable or non-rechargeable battery and power generation circuitry to generate operating power. Recharging is achieved via proximal inductive interaction between an external charger and an inductive charging coil within IMD 106. In some examples, the power requirement may be small enough to allow IMD 106 to utilize patient movement and implement kinetic energy clearance devices to trickle charge the rechargeable battery. In other examples, conventional batteries may have a limited lifespan. In still other examples, IMD 106 may include a power receiving antenna with corresponding circuitry for continuously receiving external power, enabling IMD 106 to deliver electric field therapy indefinitely without potential internal power consumption.

[0072] According to the technology disclosed herein, the processing circuitry 210 of the IMD 106 delivers electrical stimulation therapy to the patient 112 via electrodes 116 disposed on the structure 130. The AEF or FTTF therapy is defined by one or more therapy procedures 214, which have one or more parameters stored in the memory 211. For example, one or more parameters include current amplitude (for a current control system) or voltage amplitude (for a voltage control system), pulse frequency or frequency, and pulse width or the number of pulses per cycle. In an example of delivering electrical stimulation based on a “burst” of pulses or a series of electrical pulses defined by “on time” and “off time,” one or more parameters may also define one or more of the number of pulses per burst, on time, and off time.

[0073] One or more features determined from the sensed electrical signal may include or represent different characteristics of the sensed electrical signal. Example features of the sensed electrical signal may include voltage (peak or average), orientation of the generated electric field, impedance, spectral power, one or more frequencies, one or more frequency bands, or any other characteristic of the sensed signal. Thus, one or more features may be features in the time domain, frequency domain, or any other signal domain associated with identifying the sensed signal. For example, processing circuitry 210 may be configured to determine one or more features by at least determining the sensed voltage for each of a plurality of electrode combinations. In some examples, processing circuitry 210 may be configured to determine one or more features by at least determining at least one of the power, frequency band, time-domain characteristics, and / or frequency-domain characteristics of each of a plurality of signals from a respective electrode combination of a plurality of electrode combinations.

[0074] Processing circuitry 210 may be configured to control the user interface to display various elements and aspects related to the planning and delivery of AEF or FTTF therapy. For example, processing circuitry 210 may transmit sensed data (such as impedance tomography, stimulation parameters, patient activity) and any other data related to AEF or FTTF therapy to programmer 104 for display to the user via the user interface. In some examples, processing circuitry 210 may be configured to receive the user's selection of values ​​for one or more stimulation parameters that at least partially define the AEF or FTTF therapy. For example, the user interface may present visual indications of the estimated location of the target tissue and changes in electric field intensity at different locations within the target tissue.

[0075] In some examples, any or all of the components of the previously discussed IMD 106 may be contained within a deployable elastomeric structure (such as...). Figure 1 Within structure 130. For example, structure 130 may include processing circuitry for controlling and delivering electrical stimulation therapy, and does not require a wired connection to another device. In some examples where structure 130 is capable of delivering therapy on its own, structure 130 may include a power source (e.g., a battery). However, in some examples, structure 130 is capable of wirelessly receiving energy from a device external to patient 112 and delivering electrical stimulation energy in the absence of a power source (e.g., no battery power transfer, such as ultrasound or radio frequency sources).

[0076] Figure 3 Examples of delivery of controlled therapies based on the technology disclosed herein. Figure 1A block diagram of an external programmer. Although programmer 104 is typically described as a handheld device, it can be a larger portable device or a more stationary device. In some examples, programmer 104 may be referred to as a tablet computing device or a smartphone computing device. Furthermore, in other examples, programmer 104 may be included as part of a bedside monitor and an external charging device, or may include the functionality of an external charging device. Figure 3 As illustrated, programmer 104 may include processing circuitry 310, memory 311, user interface 302, telemetry module 308, and power supply 320. Throughout this disclosure, memory 311 may store instructions that, when executed by processing circuitry 310, enable processing circuitry 310 and external programmer 104 to provide functionality attributable to external programmer 104. Each of these components or modules may include circuitry configured to perform some or all of the functionality described herein. For example, processing circuitry 310 may include processing circuitry configured to perform the processes discussed relative to processing circuitry 310.

[0077] Generally, programmer 104 includes any suitable hardware arrangement, either alone or in combination with software and / or firmware, to execute techniques belonging to programmer 104 and its processing circuitry 310, user interface 302, and telemetry module 308. In various examples, programmer 104 may include one or more processors, which may include fixed-function processing circuitry and / or programmable processing circuitry, such as those formed by, for example, one or more microprocessors, DSPs, ASICs, FPGAs, or any other equivalent integrated or discrete logic circuitry, and any combination of such components. In various examples, programmer 104 may also include memory 311 (such as RAM, ROM, PROM, EPROM, EEPROM, flash memory, hard disk, CD-ROM) containing executable instructions for causing one or more processors to perform actions belonging to them. Furthermore, although processing circuitry 310 and telemetry module 308 are described as separate modules, in some examples, processing circuitry 310 and telemetry module 308 may be functionally integrated with each other. However, in some examples, the processing circuit 310 and the telemetry module 308 correspond to separate hardware units, such as ASICs, DSPs, FPGAs, or other hardware units.

[0078] Throughout this disclosure, memory 311 (e.g., a storage device) may store instructions that, when executed by processing circuitry 310, enable processing circuitry 310 and programmer 104 to provide functionality attributable to programmer 104. For example, memory 311 may include instructions that enable processing circuitry 310 to retrieve a set of parameters from memory, present a patient anatomical model for predicting electric field intensity, provide an interface that recommends or otherwise facilitates the selection of parameter values, receive user input and send corresponding commands to IMD 106, or perform any other functionality. Furthermore, memory 311 may include multiple programs, each including a set of parameters defining the stimulation therapy.

[0079] User interface 302 may include buttons or a keypad, lights, a speaker for voice commands, and a display (such as a liquid crystal (LCD), a light-emitting diode (LED), or an organic light-emitting diode (OLED)). In some examples, the display may be a presence-sensitive screen, such as a touchscreen. User interface 302 may be configured to display any information related to the delivery of stimulation therapy, detected triggering events, the progress of therapy, suggested stimulation parameter values, sensed patient parameter values, or any other such information. User interface 302 may also receive user input. Input may be, for example, pressing a button on a keypad or selecting an icon from a touchscreen.

[0080] Telemetry module 308 can support wireless communication between IMD 106 and programmer 104 under the control of processing circuitry 310. Telemetry module 308 can also be configured to communicate with another computing device via wireless communication technology or directly with another computing device via a wired connection. In some examples, telemetry module 308 provides wireless communication via RF or proximal sensing media. In some examples, telemetry module 308 includes an antenna, which can take various forms, such as an internal antenna or an external antenna. In some examples, IMD 106 and / or programmer 104 can communicate with a remote server via one or more cloud services to deliver and / or receive information between the clinic and / or programmer.

[0081] Examples of local wireless communication technologies that can be used to facilitate communication between programmer 104 and IMD 106 include RF communication according to 802.11 or the Bluetooth specification set or other standards or proprietary telemetry protocols. Security protocols and encryption technologies can be applied to enhance the security of the communication technologies. Furthermore, other external devices can be able to communicate with programmer 104 without establishing a secure wireless connection. As described herein, telemetry module 308 can be configured to transmit spatial electrode movement patterns or other stimulation parameter values ​​to IMD 106 for the delivery of stimulation therapy.

[0082] Figure 4 An example of a deformable elastomeric structure 430 is shown. Structure 430 can be a combination of... Figure 1 An example of the described structure 130. Structure 430 may define a main surface 432. Structure 430 includes a pattern of repeating cells 438 (e.g., expansion cells) forming the main surface 432. Cells 438 may be configured to expand in response to stimuli (e.g., directional forces, such as tension or compression applied to structure 430). For example, tension or compression applied to certain areas (e.g., opposite ends of the main surface 432 of structure 430) may cause structure 430 to expand into a non-planar configuration. Cells 438 may be configured to transition structure 430 between a compact configuration 434 (which has a substantially simpler shape factor, such as a sheet, cylinder, or other shape) and an expanded configuration 436 (which has one or more curved portions in 3D). In the compact configuration, structure 430 may be substantially flat or 2D. Structure 430 may be connected via a plurality of fixed points 418 (in Figure 4 The examples shown individually as 418A, 418B, and 418C (also referred to herein as fixed point 418 or one or more fixed points 418) carry one or more electrodes or one or more leads.

[0083] exist Figure 4 In the examples, structure 430 can transform between a compact configuration 434 and an expanded configuration 436. In some examples, in the compact configuration 434, which may be the first configuration, structure 430 is substantially flat (e.g., flat or substantially flat to the extent permissible by manufacturing tolerances or taking into account minor variations). In some examples, substantially flat may mean that structure 430 rises to a height less than 5% of the length of structure 430 (e.g., for a length of 100 mm, the curvature is less than 5 mm). For example, in the compact configuration 434, the main surface 432 resides in a two-dimensional plane such that the main surface 432 is substantially flat and has no three-dimensional profile extending from the main surface 432. In some examples, when structure 430 is in the compact configuration 434, cell 438 collapses such that the main surface 432 is substantially flat. Although Figure 4 The example represents the first configuration as where structure 430 is a substantially flat configuration, but the first configuration may include other configurations, including but not limited to flat or substantially flat sheets, cylinders (e.g., cylinders with uniform side surfaces) or other simple shape factors.

[0084] In some examples, in an inflated configuration 436, which may be a second configuration, structure 430 defines one or more three-dimensional contours. For example, in inflated configuration 436, the main surface 432 is unfolded to conform to a three-dimensional contour (e.g., the three-dimensional contour of a resected tumor). In some examples, when structure 430 is in inflated configuration 436, cell 438 inflates such that the main surface 432 resides in three-dimensional space and does not have a substantially flat main surface.

[0085] In some examples, structure 430 is a bistable elastotropic structure. In its bistable elastotropic state, structure 430 can reside in a compact configuration 434 (e.g., a first stable configuration) or an expanded configuration 436 (e.g., a second stable configuration) without any additional force holding it in the respective configuration. For example, when a first stimulus (e.g., a first directional force, such as tension or compression applied to either end of structure 430) is applied to structure 430 to transform it from compact configuration 434 to expanded configuration 436, structure 430 will remain in expanded configuration 436 even when the first stimulus is removed. Similarly, when a second stimulus (e.g., a second directional force, such as tension or compression applied to either end of structure 430) is applied to structure 430 to transform it back from expanded configuration 436 to compact configuration 434, structure 430 will remain in compact configuration 434 even when the second stimulus is removed. In some examples, structure 430 is unstable when configured between a compact configuration 434 (e.g., a first stable configuration) and an expanded configuration 436 (e.g., a second stable configuration). For example, in an intermediate configuration between compact configuration 434 and expanded configuration 436, structure 430 will tend to transform to either compact configuration 434 or expanded configuration 436 (e.g., depending on whether the intermediate configuration is closer to compact configuration 434 or expanded configuration 436). In other examples, structure 430 is not bistable and requires a force to hold structure 430 in expanded configuration 436 (e.g., a balloon, heat setting, or other type of force or treatment to hold structure 430 in expanded configuration 436).

[0086] exist Figure 4In the example, cell 438 includes multiple elements 446A, 446B, and 446N (collectively referred to below as multiple elements 446) configured to move or transform such that structure 430 transforms between a compact configuration 434 and an expanded configuration 436. For example, each cell in cell 438 includes multiple elements 446 such that, in the expanded configuration 436, the multiple elements have increased distances between adjacent elements in the multiple elements 446 compared to the compact configuration 434. In the compact configuration 434, each element in the multiple elements 446 may be in contact with or nearly in contact with adjacent elements. When a force (e.g., a directional force, such as a tensile or compressive force) is applied to each cell in cell 438, each element in the multiple elements 446 may separate from adjacent elements in the multiple elements 446 and / or from the center or reference point of each cell in cell 438. In some examples, during the transformation from the compact configuration 434 to the expanded configuration 436, each element in the multiple elements 446 moves uniformly relative to the other elements in the multiple elements 446. However, in some examples, during the transformation from compact configuration 434 to bloated configuration 436, each of the plurality of elements 446 moves differently relative to the other elements of the plurality of elements 446.

[0087] In some examples, each cell in cell 438 may be unique and produce a specific profile (e.g., a three-dimensional profile) upon expansion, such that when each cell in cell 438 expands, structure 430 defines a specific three-dimensional profile (e.g., a predetermined profile) in expansion configuration 436. During manufacturing, the individual configuration, orientation, and arrangement of each cell in cell 438 relative to each other can determine the final expanded three-dimensional profile of structure 430, which may correspond to a specific profile of the patient's anatomy (e.g., the profile of the patient's resected tumor bed). However, in some examples, the specific three-dimensional profile of structure 430 in expansion configuration 436 may not be patient-specific, but rather a general or common shape suitable for a given therapeutic application. In some examples, the overall shape of structure 430 may not be patient-specific, but the shape of structure 430 may be further refined to a specific profile of the patient's anatomy.

[0088] exist Figure 4In the example, structure 430 is manufactured in a compact configuration 434 (e.g., where structure 430 is substantially flat and / or surface 432 does not define any three-dimensional contour) (e.g., where cell 438 is formed by surface 432). Manufacturing in a compact configuration 434 reduces the complexity and physical space required for manufacturing and improves the accuracy and reproducibility of structures such as structure 430. For example, multiple structures such as structure 430 can be mass-produced in a substantially flat orientation and further stored until unfolded into an expanded configuration in which the structure defines one or more three-dimensional contours (e.g., before or during surgery, when structure 430 is placed in the body of patient 112). During the manufacturing process, a series of cuts (or in some examples, a series of notches, grooves, recesses, indentations, etc.) are formed in the main surface 432 to produce cell 438. The cuts defining each cell in cell 438 can be made by any suitable process, including physical cutting, etching, chemical material removal, or laser cutting, etc. In some examples, material may also be removed from structure 430 when a cut is formed during the manufacturing process, such that each cell in cell 438 defines one or more gaps (e.g., gaps in material) within each cell. The cut into cell 438 may define multiple elements 446.

[0089] In some examples, cell 438 may be shaped and / or arranged (e.g., to repeat a pattern of unit cells) such that each cell in cell 438 is connected to one or more adjacent cells. Figure 4 In the examples, when structure 430 is in a compact configuration 434, each cell of cell 438 defines a hexagon (e.g., the outer edges of each stretching cell collectively define a hexagon), and each cell of cell 438 connects to an adjacent stretching cell at each edge of the hexagon. While each cell in cell 438 is shown as a hexagon, each cell in cell 438 may define any suitable shape of cell (triangle, square, rectangle, pentagon, irregular shape, etc.). In some examples, each cell of cell 438 defines the same external shape and size (but the internal cutouts within each stretching cell may be different). In some examples, cell 438 may define a repeating pattern. In some examples, each cell in cell 438 may define a different external shape and size compared to the other cells of cell 438.

[0090] In some examples, the expanded configuration 436 of structure 430 includes a contour associated with one or more predetermined target locations for therapy within a patient. For example, a generic map or patient-specific map (e.g., from a computed tomography (CT) scan) of the resected tumor bed may be provided during the fabrication process of structure 430, such that cell 438 is generated as a three-dimensional contour of structure 430 corresponding to or otherwise fitted to the patient-specific map. Furthermore, each of the plurality of anchor points 418 for multiple electrodes or multiple leads may correspond to one or more predetermined target locations for placing one or more electrodes or for carrying one or more electrodes. When one or more electrodes are coupled to, disposed on, or carried by structure 430, the positions of the electrodes on structure 430 may correspond to one or more predetermined target locations within the patient for therapy delivery (e.g., such as when structure 430 is in expanded configuration 436). While structure 430 is described primarily with respect to a target location within the resected tumor bed in patient 112, other target locations for therapeutic delivery of structure 430 are also possible (e.g., via a cylindrical structure wrapped around a nerve or nerve bundle). Additionally, while structure 430 is described primarily with respect to a target location within the brain 120 of patient 112, other suitable locations are also possible (e.g., within soft tissue, bone, organs, etc.).

[0091] Structure 430 may be sized according to the target location of the brain and the type of therapy being delivered. For example, structure 430 may include a thickness of approximately 1 millimeter (e.g., between 0.5 and 1.5 millimeters) and have a uniform thickness overall. In some examples, the thickness of structure 430 may vary. In some examples, the thickness of structure 430 may change (e.g., increase or decrease) when structure 430 is unfolded from a compact configuration 434 or transformed into an expanded configuration 436.

[0092] exist Figure 4 In some examples, structure 430 may be a non-conductive material, such as a polymer, ceramic, or non-conductive metal. In some examples, structure 430 may comprise a flexible material configured to conform to one or more patient anatomical features (e.g., the geometry of a resected tumor bed). However, in some examples, structure 430 may comprise a rigid material, but structure 430 may still conform to one or more patient anatomical features because the three-dimensional profile of structure 430 allows for flexibility at joints within cell 438. In other examples, structure 430 may be formed of a conductive material capable of conducting current to tissue. In some examples, portions of structure 430 may be covered (e.g., coated) with an electrically insulating material, while other portions of structure 430 are exposed to conduct current to the tissue at those exposed portions.

[0093] Figure 5 Another example structure 530 is illustrated, which may be an expandable stretchable structure including multiple electrodes 516 (shown as electrodes 516A, 516B, and 516C, respectively) and / or multiple conductors 515 (shown as conductors 515A, 515B, and 515C, respectively) for coupling to the structure 530 a plurality of fixing points 518 (shown as fixing points 518A, 518B, and 518C, respectively). Structure 530 may be respectively coupled with... Figure 1 or Figure 4 Examples of structure 130 or structure 430 are shown. Figure 5 In the example, lead 514 is coupled to IMD 506 via connector 508. Lead 514 extends from IMD 506 to structure 530, and lead 514 is divided into multiple conductors 515 (e.g., lead 514 is divided into conductor 515A, conductor 515B, and conductor 515C). The multiple conductors 515 may be disposed on the surface of structure 530 (e.g., the surface opposite electrode 516) or within structure 530 (e.g., between the main surfaces of structure 530). The multiple conductors 515 may be electrically coupled to electrode 516 and / or lead 514. The multiple conductors 515 may be fed through corresponding multiple fixing points 518. Additionally or alternatively, leads (such as lead 514) coupled to IMD 506 via connector 508 are directly connected to structure 530.

[0094] In some examples, structure 530 includes a conductive material that facilitates the transfer of electrical energy from lead 514 to multiple electrodes 516 without requiring the multiple electrodes 516 to be coupled to or carried by lead 514 or multiple conductors 515. In examples where structure 530 facilitates the transfer of electrical energy from lead 514 to multiple electrodes 516, structure 530 may include a conductive material. In some examples, a majority of structure 530 comprises a conductive material (e.g., a conductive metal). However, in some examples, structure 530 includes a conductive channel (e.g., a wire) throughout structure 530 to facilitate the transfer of electrical energy from lead 514 to multiple electrodes 516.

[0095] Although Figure 5The example illustrates only a single lead 514 connecting multiple electrodes 516 and / or multiple conductors 515 to the IMD 506, but multiple leads may be attached to the structure 530 (e.g., to serve as redundant electrical connections or to deliver electrical energy to different areas of the structure 530). Similarly, although the multiple electrodes 516 are shown only as a total of three electrodes, the multiple electrodes 516 may include any number of electrodes or combinations of electrodes. For example, the structure 530 may carry any suitable number of electrodes (e.g., one, two, three, four, or more electrodes, depending on the target area of ​​the therapy and the type of therapy being delivered).

[0096] exist Figure 5 In some examples, multiple electrodes 516 and / or multiple conductors 515 are coupled to structure 530 via multiple fixing points 518. In some examples, fixing points 518 may include one or more threaded holes that engage with corresponding threads on the multiple electrodes 516, the multiple conductors 515, or shafts coupled to the electrodes 516 or conductors 515. Although Figure 5 The example shows multiple fixing points 518 as threaded holes, but multiple fixing points 518 may include any suitable mechanism for coupling multiple electrodes 516 and / or multiple conductors 515 to structure 530, including but not limited to press fit (e.g., interference fit), laser welding, material reflow, etc. Multiple electrodes 516 and / or multiple conductors 515 may be used when structure 530 is substantially flat (e.g., as shown in the example). Figure 4 The compact configuration 434 shown is shown, or the structure 430 is converted into an expanded configuration (e.g., as shown). Figure 4 The expansion configuration 436 shown is attached afterward.

[0097] Figure 6 An example structure 630 is illustrated, which can be an expandable stretchable structure including multiple fixing points 618 (shown as 618A, 618B, and 618C, respectively) for coupling multiple leads 614 (shown as 614A, 614B, and 614C, respectively) to the structure 630. The structure 630 can be respectively coupled... Figure 1 or Figure 4 Examples of structures 130 or 430 are shown. In addition to those described herein, structure 630 can also be used with, for example... Figure 5 The described structure 530 shares a characteristic region. In Figure 6 In the example, IMD 606 includes multiple leads 614 electrically coupled to IMD 606 via connector 608, and multiple electrodes 616 (shown as 616A, 616B and 616C respectively) disposed on or carried by the multiple leads 614.

[0098] exist Figure 6In some examples, multiple leads 614 are coupled to structure 630 via multiple anchor points 618. However, in some examples, multiple electrodes 616 are coupled to structure 630 via multiple anchor points 618, while also being positively coupled to the multiple leads 614. In some examples, the anchor points 618 may be one or more threaded holes that mate with corresponding threads of the multiple leads 614. For example, the multiple leads 614 may be screwed or threaded into structure 630 to couple the multiple leads 614 to structure 630. In some examples, the multiple leads 614 may subsequently be separated from structure 630 by unscrewing or unscrewing them from the multiple anchor points 618. In some examples, the multiple leads 614 may be coupled to structure 630 such that the multiple electrodes 616 extend away from structure 630 to a defined length, which may vary (e.g., such that the multiple electrodes 616 penetrate the patient's tissue at a target depth). Although Figure 6 The example shows multiple fixing points 618 as threaded holes, but multiple fixing points 618 may include any suitable mechanism for coupling multiple leads 614 or multiple electrodes 618 to structure 630, including but not limited to press fit (e.g., interference fit), laser welding, material reflow, etc.

[0099] although Figure 6 The example shows multiple leads 614 as three leads, each carrying one electrode; however, multiple leads can include any suitable number of leads (e.g., one, two, three, or more, depending on the target area of ​​the therapy and the type of therapy being delivered). Similarly, although multiple electrodes 616 are only shown as three electrodes in total, multiple electrodes 616 can include any number of electrodes or combinations of electrodes. For example, each lead in multiple leads 614 can carry one or more electrodes (e.g., one, two, three, four, or more electrodes, depending on the target area of ​​the therapy and the type of therapy being delivered).

[0100] In some examples, when structure 630 is in a compact configuration ( Figure 4In a compact configuration 434, multiple leads 614 or multiple electrodes 616 are attached to structure 630 via attachments at multiple fixing points 618. For example, a first lead 614A is attached to structure 630 via a first fixing point 618A, such that electrode 616A is positioned away from structure 630 at a first distance (e.g., a first distance measured from the center of electrode 616A to the surface of structure 630); a second lead 614B is attached to structure 630 via a second fixing point 618B, such that electrode 616B is positioned away from structure 630 at a second distance (e.g., a second distance measured from the center of electrode 616B to the surface of structure 630); and a third lead 614C is attached to structure 630 via a third fixing point 618C, such that electrode 616C is positioned away from structure 630 at a third distance (e.g., a third distance measured from the center of electrode 616C to the surface of structure 630). When structure 630 is substantially flat (e.g., as in...), Figure 4 The compact configuration 434 shown is either used, or the structure 630 is converted to an expanded configuration (e.g., as shown). Figure 4 After the expansion configuration 436 shown, multiple leads 614 can be attached.

[0101] Figure 7 This is a flowchart describing an example technique for manufacturing structures (e.g., any of structures 130, 430, 530, and 630), and relative to... Figure 4 The structure 430 is described above. In some examples, one method includes generating structure 430 (700). As described above, structure 430 may be an expandable elastomeric structure. Structure 430 is capable of changing between a compact configuration 434 and an expanded configuration 436. In some examples, generating structure 430 includes creating a plurality of cells 438 within structure 430, which may be a plurality of elastomeric cells. When creating a plurality of cells 438 within structure 430, structure 430 may be in a first configuration (e.g., compact configuration 434). For example, generating structure 430 may occur when structure 430 is in compact configuration 434 and the main surface 432 is substantially flat, including forming cuts to create cells 438, which simplifies the manufacturing process and reduces the space required. As described above, creating cells 438 may include creating cuts in the structure using any suitable technique (e.g., physical cutting, etching, chemical material removal, laser cutting, etc.). In some examples, when a cut is formed in structure 430, material may also be removed from structure 430, such that each cell in cell 438 defines one or more gaps (e.g., gaps in material) within each cell. The cut into cell 438 may define multiple elements 446.

[0102] continue Figure 7For example, the technology also includes defining one or more locations for attaching a plurality of electrodes 116 (702). For attaching a plurality of electrodes 116 (e.g., as...) Figure 1 One or more locations (as shown) may include a plurality of fixing points 418. In some examples, the locations of the plurality of fixing points 418 may be determined before attaching the plurality of electrodes 116 to the structure 430. Defining one or more locations to attach the plurality of electrodes 116 may include: creating the plurality of fixing points 418. As previously discussed, for the plurality of electrodes 416 or the plurality of leads 114 (e.g., as shown) Figure 1 Each of the plurality of anchor points 418 (shown) may correspond to one or more predetermined target locations for placing one or more electrodes or for one or more leads carrying one or more electrodes. When one or more electrodes are positioned on structure 430, the positions of the electrodes on structure 430 may correspond to one or more predetermined target locations within the patient for therapy delivery. For example, a generic map of the resected tumor bed or a patient-specific map (e.g., from a computed tomography (CT) scan) may be provided, such that cell 438 is generated as a three-dimensional profile of structure 430 corresponding to the map or otherwise fitted to the patient-specific map. In some examples, the locations for placing electrodes 116 on structure 430 may define a particular electrode array, but may not otherwise be specific to a particular tumor cavity in the patient.

[0103] continue Figure 7 As an example, the technique also includes attaching one or more electrodes 116 to structure 430 (704). Structure 430 may include for attaching one or more electrodes 116 or one or more leads 114 (e.g., as shown in the image). Figure 1 Multiple fixing points 418 (as shown). The multiple fixing points 418 may include threaded holes or another attachment mechanism, such as, but not limited to, press fits (e.g., interference fits), laser welding, material reflow, etc. In some examples, attaching one or more electrodes 116 to the structure 430 includes attaching the electrodes 116 to the structure 430 via one or more threaded holes, wherein the threaded holes are located at the multiple fixing points 418. Additionally or alternatively, the one or more electrodes 116 may be defined by the structure 430 by removing insulating material to expose conductive material on the surface of the structure 430. Attaching one or more electrodes 116 to the structure may occur when the structure 430 is in a compact configuration 434 (e.g., when the structure 430 is substantially flat). Additionally or alternatively, attaching the electrodes 116 may occur after the structure 430 is expanded to an expanded configuration 436.

[0104] Figure 8 This is a flowchart describing an example technique for implanting and / or inserting a transformable structure into a patient's body, and is relative to... Figure 1 System 100 Figure 1 and Figure 2 IMD 106 Figure 3 Programmer 104 and Figure 4 The structure described in 430. Figure 8 In one example, the technique includes transforming the transformable structure 430 from a compact configuration (e.g., expanding) to an expanded configuration (800). The expansion of structure 430 may occur within the patient 112 (e.g., within the skull 122) or outside the patient 112. For example, the expansion of structure 430 may occur before and / or after insertion of structure 430 into the patient 112. In some examples, structure 430 is partially unfolded and / or expanded before insertion into the patient 112, and / or further expanded to a fully unfolded configuration after insertion.

[0105] continue Figure 8 As an example, the technique also includes inserting a variable structure 430 into the body of patient 112 (802). Structure 430 may be inserted into the brain 120 of patient 112. Structure 430 may be implanted in the right and / or left hemisphere of patient 112 to deliver therapy to one or more regions of brain 120 and / or sense one or more patient parameters via one or more electrodes 116 disposed on structure 430. In some examples, one or more electrodes 116 are detached from structure 430 and remain in the brain 120 of patient 112, and structure 430 is removed. However, in some examples, one or more electrodes remain attached to structure 430, and structure 430 remains implanted in patient 112.

[0106] continue Figure 8 As an example, the technology also includes receiving a request (804) for the delivery of a therapy (e.g., alternating electric field (AEF) or focused tumor therapeutic field (FTTF) therapy) via processing circuitry (e.g., processing circuitry 210 of IMD 106 or processing circuitry 310 of programmer 104). In some examples, system 100 includes processing circuitry configured to receive a request for the delivery of alternating electric field (AEF) or focused tumor therapeutic field (FTTF) therapy. This request can be initiated via user input (such as via programmer 104) and / or an automated system request to initiate AEF or FTTF therapy delivery.

[0107] continue Figure 8As an example, the technique also includes delivering therapy (806) via one or more electrodes disposed on the transformable structure 130. As previously described, structure 130 is configured to have a compact configuration (e.g., compact configuration 434), in which structure 130 is substantially flat. Structure 130 is deformable (or can be expanded) into an expanded configuration (e.g., expanded configuration 436), in which structure 130 defines one or more three-dimensional contours. In some examples, therapy is delivered via one or more electrodes 116 disposed on structure 130.

[0108] The techniques described in this disclosure can be implemented, at least in part, in hardware, software, firmware, or any combination thereof. For example, aspects of the described techniques can be implemented within one or more processors, such as fixed-function processing circuitry and / or programmable processing circuitry, including one or more microprocessors, digital signal processors (DSPs), application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), or any other equivalent integrated or discrete logic circuitry, and any combination of such components. The terms "processor" or "processing circuitry" can generally refer to any of the aforementioned logic circuitry, alone or in combination with other logic circuitry, or any other equivalent circuitry. A control unit, including hardware, can also perform one or more of the techniques disclosed herein.

[0109] Such hardware, software, and firmware can be implemented within the same device or in separate devices to support the various operations and functions described in this disclosure. Furthermore, any of the described units, modules, or components can be implemented together or separately as discrete but interoperable logical devices. Describing different features as modules or units is intended to highlight different functional aspects and does not necessarily imply that such modules or units must be implemented by separate hardware or software components. Rather, the functionality associated with one or more modules or units can be performed by separate hardware or software components, or integrated within common or separate hardware or software components.

[0110] This document describes one or more embodiments.

[0111] Example 1. A system comprising: a structure including a pattern of repeating cells, the pattern being configured to transition between a compact configuration and an expanded configuration, wherein: the structure is substantially flat in the compact configuration, the structure defines one or more three-dimensional contours in the expanded configuration, and each cell in the repeating cells includes a plurality of elements, wherein, in the expanded configuration, the plurality of elements have increased distances between adjacent elements among the plurality of elements; and one or more electrodes disposed on the structure.

[0112] Example 2. The system according to Example 1, wherein the repeating cell includes a plurality of stretching cells.

[0113] Example 3. The system according to Example 2, wherein one or more of the plurality of expansion cells are configured to expand in response to force.

[0114] Example 4. The system according to Examples 1 to 3, wherein one or more electrodes are configured to deliver focused tumor therapeutic field (FTTF) therapy.

[0115] Example 5. The system according to Examples 1 to 4, wherein when the structure is transformed into the expanded configuration, the one or more electrodes are configured to deliver therapy to one or more predetermined target locations within the patient's body.

[0116] Example 6. The system according to Examples 1 to 5, wherein one or more electrodes are defined by corresponding portions of the structure.

[0117] Example 7. The system according to Examples 1 to 6, wherein one or more electrodes are coupled to the structure.

[0118] Example 8. The system according to Examples 1 to 7, wherein when the structure is in the expanded configuration, the one or more electrodes are coupled to corresponding different locations on the structure corresponding to one or more predetermined target locations within the patient body for therapeutic delivery.

[0119] Example 9. The system according to Examples 1 to 8, wherein the structure is a bistable structure including a first stable configuration and a second stable configuration, wherein the bistable structure is unstable when in a configuration between the first stable configuration and the second stable configuration, wherein the compact configuration is the first stable configuration, and wherein the expanded configuration is the second stable configuration.

[0120] Example 10. A method comprising: generating a structure including a pattern of repeating cells, the pattern being configured to transition the structure between a compact configuration and an expanded configuration, wherein: the structure is substantially flat in the compact configuration, the structure defines one or more three-dimensional contours in the expanded configuration, and each cell in the repeating cells includes a plurality of elements, wherein, in the expanded configuration, the plurality of elements have increased distances between adjacent elements among the plurality of elements; and attaching one or more electrodes to the structure.

[0121] Example 11. The method according to Example 10, wherein the repeating cell includes a plurality of stretching cells.

[0122] Example 12. The method according to Examples 10 to 11, wherein when the structure is generated, the structure is in the compact configuration.

[0123] Example 13. The method according to Examples 10 to 12, wherein generating the structure includes: creating cuts in the structure to define the pattern of repeating cells.

[0124] Example 14. The method according to Examples 11 to 13, wherein one or more of the plurality of expansion cells are configured to expand in response to force.

[0125] Example 15. The method according to Examples 10 to 14, wherein the one or more three-dimensional contours include one or more predetermined contours generated from the patient's anatomical structures.

[0126] Example 16. The method according to Examples 10 to 15, wherein attaching the one or more electrodes to the structure comprises at least: attaching the one or more electrodes to the structure via one or more threaded holes.

[0127] Example 17. The method according to Examples 10 to 16, wherein when the structure is transformed into the expanded configuration, the one or more electrodes are configured to deliver the therapy to one or more predetermined target locations within the patient's body.

[0128] Example 18. The method according to Examples 10 to 17, wherein the structure is a bistable structure including a first stable configuration and a second stable configuration, wherein the bistable structure is unstable when in a configuration between the first stable configuration and the second stable configuration, wherein the compact configuration is the first stable configuration, and wherein the expanded configuration is the second stable configuration.

[0129] Example 19. A system comprising: a bistable elastomeric structure including a pattern of repeating elastomeric cells configured to switch between a compact configuration and an expanded configuration when tension is applied to the bistable elastomeric structure, wherein: the bistable elastomeric structure is substantially flat in the compact configuration, the bistable elastomeric structure defines one or more three-dimensional contours in the expanded configuration, each elastomeric cell of the pattern of repeating elastomeric cells including a plurality of elements, the plurality of elements having an increased distance between adjacent elements in the expanded configuration compared to the compact configuration, the compact configuration being a first stable configuration, the expanded configuration being a second stable configuration, and the bistable structure being unstable in a configuration between the first stable configuration and the second stable configuration; and one or more electrodes disposed on the structure at one or more locations corresponding to predetermined target locations within a patient body for therapeutic delivery.

[0130] Example 20. The system according to Example 19, wherein the one or more three-dimensional contours are one or more predetermined contours generated from the patient's anatomical structure.

[0131] Example 21. A method comprising: transforming a convertible structure into an expanded configuration; inserting the convertible structure into a patient; receiving a request for delivery of therapy via processing circuitry; and delivering therapy via one or more electrodes disposed on the convertible structure, wherein: the structure includes a pattern of repeating cells configured to allow the structure to transition between a compact configuration and an expanded configuration, the structure being substantially flat in the compact configuration and defining one or more three-dimensional contours in the expanded configuration, and each cell in the repeating cells comprising a plurality of elements, wherein, in the expanded configuration, the plurality of elements have increased distances between adjacent elements among the plurality of elements compared to the compact configuration; and one or more electrodes disposed on the structure.

[0132] Example 22. The method according to Example 21, wherein the repeating cell includes a plurality of stretching cells.

[0133] Example 23. According to the method of Example 22, one or more of the plurality of expansion cells are configured to expand in response to force.

[0134] Example 24. The method according to any one of Examples 21 to 23, wherein the one or more electrodes are configured to deliver focused tumor therapeutic field (FTTF) therapy.

[0135] Example 25. The method according to any one of Examples 21 to 24, wherein when the structure is transformed into the expanded configuration, the one or more electrodes are configured to deliver the therapy to one or more predetermined target locations within the patient's body.

[0136] Example 26. The method according to any one of Examples 21 to 25, wherein the electrode is defined by a corresponding portion of the structure.

[0137] Example 27. The method according to any one of Examples 21 to 26, wherein the electrode is disposed on the structure.

[0138] Example 28. A system according to any one of Examples 21 to 27, wherein when the structure is in the expanded configuration, the one or more electrodes are coupled to corresponding different locations on the structure corresponding to one or more predetermined target locations within the patient for therapy delivery.

[0139] Example 29. The method according to any one of Examples 21 to 28, wherein the structure is a bistable structure including a first stable configuration and a second stable configuration, wherein the bistable structure is unstable when in a configuration between the first stable configuration and the second stable configuration, wherein the compact configuration is the first stable configuration, and wherein the expanded configuration is the second stable configuration.

[0140] Example 30. A system comprising means for performing the method according to any one of Examples 21 to 29.

Claims

1. A system comprising: A structure comprising a pattern of repeating cells, the pattern being configured to transition between a compact configuration and an bloated configuration, wherein: The structure is substantially flat in the compact configuration. The structure, when in the inflated configuration, defines one or more three-dimensional contours, and Each cell in the repeating cells comprises multiple elements, and in the bloated configuration, compared to the compact configuration, the multiple elements have increased distances between adjacent elements; and One or more electrodes are disposed on the structure.

2. The system according to claim 1, wherein the repeating cell comprises a plurality of stretching cells.

3. The system of claim 2, wherein one or more of the plurality of expansion cells are configured to expand in response to force.

4. The system according to any one of claims 1 to 3, wherein when the structure is transformed into the expanded configuration, the one or more electrodes are configured to deliver the therapy to one or more predetermined target locations within the patient's body.

5. The system according to any one of claims 1 to 4, wherein the structure is a bistable structure comprising a first stable configuration and a second stable configuration, wherein the bistable structure is unstable when in a configuration between the first stable configuration and the second stable configuration, wherein the compact configuration is the first stable configuration, and wherein the expanded configuration is the second stable configuration.

6. The system according to any one of claims 1 to 5, wherein the one or more three-dimensional contours are one or more predetermined contours generated from the anatomical structure of the patient.

7. The system according to any one of claims 1 to 6, further comprising one or more leads attached to the structure and electrically coupled to the one or more electrodes.

8. The system of claim 7, wherein one or more electrodes are disposed on one or more leads.

9. The system according to any one of claims 1 to 7, wherein the one or more electrodes are defined by a corresponding portion of the structure.

10. The system of claim 9, further comprising an electrically insulating material covering at least a portion of the structure.

11. The system according to any one of claims 1 to 7, wherein the one or more electrodes are coupled to the structure.

12. The system according to any one of claims 1 to 7, wherein when the structure is in the expanded configuration, the one or more electrodes are coupled to a corresponding different location on the structure corresponding to one or more predetermined target locations within the patient body for therapeutic delivery.

13. The system of any one of claims 1 to 12, further comprising an implantable medical device (IMD) wherein the IMD is configured to deliver therapy via the one or more electrodes.

14. The system of claim 13, wherein the IMD is configured to deliver a therapy comprising a focused tumor therapeutic field (FTTF) therapy.

15. The system of claim 14, further comprising a programmer configured to communicate with the IMD to provide or retrieve therapy information.

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