A system for determining the orientation and / or location of a lead implanted in a patient and a computer-readable storage medium.

Abstract

This disclosure provides an exemplary method comprising: obtaining an image of a lead implanted in a patient, the lead including one or more electrodes positioned along a longitudinal axis of the lead and a plurality of orientation markers; determining corresponding positions of the one or more electrodes and corresponding positions of the plurality of orientation markers in the image; determining the orientation of the longitudinal axis based on the corresponding positions of the one or more electrodes; projecting the corresponding positions of the orientation markers onto a plane orthogonal to the longitudinal axis; and determining the rotational orientation of the lead based on the projected position of a first orientation marker among the plurality of orientation markers in the plane and the projected position of a second orientation marker among the plurality of orientation markers in the plane.

Description

Technical Field

[0001] This disclosure relates to electrical stimulation therapy. Background Technology

[0002] Implantable medical devices, such as electrical stimulators or therapeutic agent delivery devices, have been proposed for various therapeutic applications, including deep brain stimulation (DBS), spinal cord stimulation (SCS), pelvic stimulation, gastric stimulation, peripheral nerve stimulation, functional electrical stimulation, or the delivery of drugs, insulin, analgesics, or anti-inflammatory agents to target tissue sites within a patient's body. In some therapeutic systems, the implantable electrical stimulator delivers electrotherapy to target tissue sites within a patient's body via one or more electrodes, which may be deployed via medical leads and / or deployed on the stimulator's housing, or both.

[0003] During a programming session, which may occur during medical device implantation, during a trial session, or in a clinic or during a remote follow-up session after the medical device has been implanted in a patient, a clinician may generate one or more therapy procedures (also called therapy parameter sets) that are found to provide an effective treatment to the patient, where each therapy procedure can define values ​​for a therapy parameter set. The medical device may deliver the treatment to the patient according to one or more stored therapy procedures. In the case of electrical stimulation, the therapy parameters can define the characteristics of the electrical stimulation waveform to be delivered. For example, in an example of delivering electrical stimulation in the form of electrical pulses, the therapy parameters may include an electrode configuration that includes an electrode combination and electrode polarity, amplitude (which may be current or voltage amplitude), pulse width, and pulse frequency. Summary of the Invention

[0004] In one example, a method includes: obtaining an image of a lead implanted in a patient, the lead including one or more electrodes positioned along a longitudinal axis of the lead and a plurality of orientation markers; determining corresponding positions of the one or more electrodes and the plurality of orientation markers in the image; determining the orientation of the longitudinal axis based on the corresponding positions of the one or more electrodes; projecting the corresponding positions of the orientation markers onto a plane orthogonal to the longitudinal axis; and determining the rotational orientation of the lead based on the projected position of a first orientation marker among the plurality of orientation markers in the plane and the projected position of a second orientation marker among the plurality of orientation markers in the plane.

[0005] In another example, a system includes: a memory; and processing circuitry configured to: acquire an image of a lead implanted in a patient, the lead including one or more electrodes positioned along a longitudinal axis of the lead and a plurality of orientation markers; determine corresponding positions of the one or more electrodes and the plurality of orientation markers in the image; determine the orientation of the longitudinal axis based on the corresponding positions of the one or more electrodes; project the corresponding positions of the orientation markers onto a plane orthogonal to the longitudinal axis; and determine the rotational orientation of the lead based on the projected position of a first orientation marker among the plurality of orientation markers in the plane and the projected position of a second orientation marker among the plurality of orientation markers in the plane.

[0006] In another example, a computer-readable storage medium stores instructions that, when executed, cause one or more processors to: acquire an image of a lead implanted in a patient, the lead including one or more electrodes positioned along a longitudinal axis of the lead and a plurality of orientation markers; determine the respective positions of the one or more electrodes and the plurality of orientation markers in the image; determine the orientation of the longitudinal axis based on the respective positions of the one or more electrodes; project the respective positions of the orientation markers onto a plane orthogonal to the longitudinal axis; and determine the rotational orientation of the lead based on the projected position of a first orientation marker among the plurality of orientation markers in the plane and the projected position of a second orientation marker among the plurality of orientation markers in the plane.

[0007] Details of one or more examples are set forth in the accompanying drawings and the following description. Other features, objectives, and advantages of this disclosure will be apparent from the specification, drawings, and claims. Attached Figure Description

[0008] Figure 1 This is a conceptual diagram illustrating an exemplary deep brain stimulation (DBS) system configured to detect leads that are configured to deliver electrical stimulation therapy to tissue sites within a patient's brain.

[0009] Figure 2 This is a functional block diagram illustrating the components of an exemplary medical device.

[0010] Figure 3 This is a conceptual diagram illustrating a component with an exemplary medical lead.

[0011] Figure 4 These are exemplary images generated by an imaging device for implanted leads within a patient's body, according to one or more techniques of this disclosure.

[0012] Figure 5 This is a conceptual diagram illustrating an exemplary projection of the position of an orientation marker according to one or more techniques of this disclosure onto a plane orthogonal to the axis of the lead.

[0013] Figure 6A and Figure 6B This is a conceptual diagram illustrating an exemplary model of leads according to one or more technologies disclosed herein.

[0014] Figure 7A and Figure 7B This is an exemplary visual concept diagram illustrating leads according to one or more technologies in accordance with this disclosure.

[0015] Figure 8 These are exemplary images generated by an imaging device for implanted leads within a patient's body, according to one or more techniques of this disclosure.

[0016] Figure 9A and Figure 9B This is an exemplary visual concept diagram illustrating leads according to one or more technologies in accordance with this disclosure.

[0017] Figure 10 This is a functional block diagram illustrating the components of an exemplary lead detection system.

[0018] Figure 11 This is a flowchart illustrating an exemplary technique for determining the orientation of a lead implanted in a patient, according to one or more techniques of this disclosure.

[0019] Figure 12 This is a flowchart illustrating another exemplary technique for determining the orientation of a lead implanted in a patient, according to one or more techniques of this disclosure. Detailed Implementation

[0020] Generally, this disclosure relates to apparatus, systems, and methods for determining the orientation and / or location of a lead implanted in a patient. The lead may include one or more electrodes for delivering electrical stimulation therapy to the patient. Some electrodes (such as a ring electrode fully disposed around the periphery of the lead housing) can deliver electrical stimulation therapy radially in all directions around the longitudinal axis of the lead. Other electrodes (such as partially ring electrodes or segmented electrodes) may be directional electrodes because they enable the electrical stimulation therapy to be delivered radially only in a specific direction around the longitudinal axis of the lead corresponding to the location of the partially ring electrode or segmented electrode. The rotational orientation of the lead (i.e., for targeting a specific tissue) can facilitate programming the stimulator to deliver therapy using electrodes with complex geometries. However, clinicians may not be able to implant a lead with a specific rotational orientation, and / or the lead may rotate about the longitudinal axis after initial insertion (e.g., during lead fixation and / or over time as it is pushed into the patient).

[0021] According to one or more techniques of this disclosure, a system can use images of a patient to determine the orientation and / or location of a lead implanted in the patient's body. The lead may include various features that facilitate the determination of lead orientation. For example, the lead may include multiple orientation markers at specific locations. These orientation markers may be configured (e.g., shaped and / or made of certain materials) to be detectable in the images.

[0022] During operation, the system can acquire image data (e.g., CT images) representing at least one patient region in which a lead is implanted (e.g., a patient's head in which a lead is implanted in the patient's brain). The system can analyze the image data to determine the orientation and / or location of the lead. For example, the system can identify the corresponding location of an electrode and the corresponding location of an orientation marker.

[0023] The system can use any combination of various techniques to determine the orientation and / or location of the lead based on the identified positions of the electrodes and orientation markers. In a first technique, the system can determine the axis of the image based on the position of the electrodes, generate a projection line between a first and a second orientation marker in a plane orthogonal to the axis, and determine the rotational orientation of the lead based on the angle of the projection line. In a second technique, the system can match the positions of the electrodes and markers with a template model of the lead (e.g., using an algorithm based on singular value decomposition (SVD), and determine the orientation of the lead based on the match.

[0024] The system can provide results (i.e., the predicted orientation and / or location of the electrode) to a practicing physician (e.g., a physician, physician's assistant, or other clinician). As an example, the system can output a graphical indication (e.g., visualization) of the lead at implantation for display purposes. For instance, the system can output a graphical representation of the lead at implantation overlaid on a patient image (e.g., the lead can be shown relative to various anatomical landmarks). As another example, the system can output a differential angle representing the difference between the target orientation and the determined orientation.

[0025] Figure 1This is a conceptual diagram illustrating an exemplary therapeutic system 10 including a lead 50 implanted in the brain 49 of a patient 40. For ease of illustration, examples of this disclosure will be described primarily with reference to implantable electrical stimulation leads and implantable medical devices that deliver neurostimulation therapy to the brain 49 of a patient 40 in the form of deep brain stimulation (DBS). However, the features and techniques described herein can be used in other types of medical device systems that employ medical leads to deliver electrical stimulation to a patient and / or sense electrical signals via one or more electrodes of the leads. For example, the features and techniques described herein can be used in systems having a medical device that delivers stimulation therapy to a patient's heart, such as a pacemaker and a pacemaker-defibrillator. As other examples, the features and techniques described herein can be embodied in systems delivering other types of neurostimulation therapy (e.g., spinal cord stimulation or vagus nerve stimulation), stimulating at least one muscle or muscle group, stimulating at least one organ such as gastric system stimulation, stimulation accompanying gene therapy, and systems that typically stimulate any tissue of a patient. The medical lead system can be used with human or non-human subjects.

[0026] like Figure 1 As shown, the therapy system 10 includes a medical device programmer 30, an implantable medical device (IMD) 20, and a lead 50. The lead 50 includes a plurality of electrodes 60 and a plurality of orientation markers 82 adjacent to a distal end 54 of the lead 50. The IMD 20 includes a stimulation therapy module that includes an electrical stimulation generator that generates electrical stimulation therapy and delivers the electrical stimulation therapy to one or more regions of the brain 49 of the patient 40 via one or more of the electrodes 60. Figure 1 In the example shown, the therapy system 10 may be referred to as a DBS system because the IMD 20 delivers electrical stimulation therapy directly to the tissue within the brain 49 (e.g., the subdural tissue portion of the brain 49). In other examples, one or more leads in the leads 50 may be positioned to deliver therapy to the surface of the brain 49 (e.g., the cortical surface of the brain 49).

[0027] Lead 50 includes a distal end 54 and a proximal end 52. When assembling lead 50, a corresponding electrical connection sleeve adjacent to the proximal end 52 ( Figure 1 (Not shown) provides an electrical connection between the IMD 20 and a conductive path of the lead 50, which leads to an electrode 60 adjacent to the distal end 54, defined by a plurality of conductors of the lead 50. Using this conductive path, the IMD 20 can deliver electrical stimulation to and / or sense electrical signals from the patient 40 via the lead 50. Although Figure 1The image shows the proximal end of the lead 50 directly connected to the head of the IMD 20, but in other examples, the proximal end of the lead 50 may be connected to one or more lead extensions that are connected to the head of the IMD 20 to electrically connect the lead 50 to the IMD 20.

[0028] exist Figure 1 In the example shown, the IMD 20 may be implanted in a subcutaneous pit below the clavicle of patient 40. In other examples, the IMD 20 may be implanted in other areas of patient 40, such as in the abdomen or buttocks of patient 40, or in a subcutaneous pit near the skull 48 of patient 40. The proximal end 52 of the lead 50 is coupled to the IMD 20 via a connecting sleeve block (also referred to as the head), which may include, for example, electrical contacts electrically coupled to corresponding electrical contacts at the proximal end 52 of the lead 50. The electrical contacts are electrically coupled to an electrode 60 carried by the distal end 54 of the lead 50. The lead 50 extends from the implantation site of the IMD 20 within the chest cavity of patient 40, traverses the neck of patient 40, and passes through the skull of patient 40 to reach the brain 49. Generally, the IMD 20 is constructed of a biocompatible material resistant to corrosion and degradation by bodily fluids. The IMD 20 may include an hermetically sealed housing to substantially encapsulate components such as processors, therapeutic modules, and memory.

[0029] Lead 50 can be positioned to deliver electrical stimulation to one or more target tissue sites within brain 49 to manage patient symptoms associated with impairment in patient 40. Lead 50 can be implanted to position electrode 60 at a desired location within brain 49 through corresponding holes in skull 48. Lead 50 can be placed at any location within brain 49, allowing electrode 60 to deliver electrical stimulation to target tissue sites within brain 49 during treatment. Although Figure 1 System 10 is shown as including a single lead 50 coupled to IMD 20, but in some examples, system 10 may include more than one lead.

[0030] Lead 50 can deliver electrical stimulation via electrode 60 to treat any number of neurological disorders or conditions other than motor disorders, such as epileptic disorders or mental disorders. Lead 50 can be implanted into the desired location within brain 49 via any suitable technique, such as through a corresponding bone drill hole in the skull of patient 40 or through a common bone drill hole in skull 48. Lead 50 can be placed at any location within brain 49 such that electrode 60 of lead 50 can deliver electrical stimulation to target tissue during treatment. Figure 1 In the example shown, the electrodes 60 of the lead 50 are shown as segmented electrodes and ring electrodes. The electrodes 60 of the lead 50 may have a complex electrode array geometry capable of generating a shaped electric field. In this way, electrical stimulation can be directed from the lead 50 in a specific direction to enhance the therapeutic effect and reduce potential adverse side effects caused by stimulating a large amount of tissue.

[0031] The IMD 20 can deliver electrical stimulation therapy to the brain 49 of the patient 40 according to one or more stimulation therapy procedures. The therapy procedure can define one or more electrical stimulation parameter values ​​for the therapy generated from the IMD 20 and delivered to the brain 49 of the patient 40. In the case where the IMD 20 delivers electrical stimulation in the form of electrical pulses, the stimulation therapy can be characterized, for example, by selected pulse parameters such as pulse amplitude, pulse frequency, and pulse width. Furthermore, if different electrodes can be used to deliver stimulation, the therapy can also be characterized by different electrode combinations, which may include selected electrodes and their corresponding polarities. The exact therapy parameter values ​​for stimulation therapies that help manage or treat patient disorders can be tailored to the specific target stimulation site (e.g., brain region) involved, as well as the specific patient and patient condition.

[0032] In addition to delivering therapy to manage the impairment of patient 40, the therapy system 10 also monitors electrical signals, such as one or more bio-computer signals of patient 40. For example, IMD 20 may include a sensing module that senses bio-computer signals in one or more regions of brain 49. Figure 1 In the example shown, the signal generated by electrode 60 is conducted to the sensing module within IMD 20 via a conductor within lead 50, which includes one or more conductors located between the distal end 54 and the proximal end 52 of lead 50.

[0033] Programmer 30 wirelessly communicates with IMD 20 as needed to provide or retrieve therapy information. Programmer 30 is an external computing device that a user (e.g., a clinician and / or patient 40) can use to communicate with IMD 20. For example, programmer 30 could be a clinician programmer used by the clinician to communicate with IMD 20 and program one or more therapy procedures for IMD 20. Alternatively, programmer 30 could be a patient programmer that allows patient 40 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 20.

[0034] Programmer 30 may be a handheld computing device with a user-visible display and an interface (i.e., a user input mechanism) for providing input to programmer 30. In other examples, programmer 30 may be a larger workstation or a standalone application within another multi-functional device, rather than a dedicated computing device. For example, the multi-functional device may be a laptop, tablet, workstation, cellular phone, personal digital assistant, or another computing device capable of running an application that enables the computing device to operate as a secure medical device programmer 30.

[0035] Similarly, while lead 50 is described herein for DBS applications, lead 50 or other leads can be implanted at any other location within the patient 40. For example, lead 50 can be implanted near the spinal cord, pudendal nerve, sacral nerve, or any other nerve or muscle tissue that can be stimulated. The user interface described herein can be used to program stimulation parameters for any type of stimulation therapy. In the case of pelvic nerves, defining the stimulation field allows clinicians to stimulate multiple desired nerves without placing multiple leads deep within the patient 40 and adjacent to sensitive nerve tissue. The therapy can also be modified if the leads migrate to a new location within the tissue or if the patient 40 no longer perceives the therapeutic effect of the stimulation. The features or techniques of this disclosure can be used in other types of medical applications.

[0036] Figure 2 This is a functional block diagram showing the components of IMD 20. As shown, the therapy system 10 includes IMD 20 coupled to lead 50. Figure 2 In the example, IMD 20 includes processor circuitry 24 (also referred to as a “processor” or “processing circuitry”), memory 26, stimulus generator 21, sensing module 22, telemetry module 23, sensor 25, and power supply 29. Each of these components (also referred to as “modules”) may be or may include circuitry configured to perform functions belonging to each respective module. For example, processor 24 may include processing circuitry, stimulus generator 21 may include switching circuitry, sensing module 22 may include sensing circuitry, and telemetry module 23 may include telemetry circuitry. Memory 26 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), flash memory, etc. Memory 26 may store computer-readable instructions that, when executed by processor 24, cause IMD 20 to perform various functions. Memory 26 may be a storage device or other non-transitory medium.

[0037] Processor 24 may include one or more of the following: microprocessor, controller, digital signal processor (DSP), application-specific integrated circuit (ASIC), field-programmable gate array (FPGA), discrete logic circuit, or any other processing circuit configured to provide the functions attributed to processor 24. The processor may be embodied herein as firmware, hardware, software, or any combination thereof. Processor 24 controls stimulus generator 21 to apply specific stimulus parameter values, such as amplitude, pulse width, and pulse frequency.

[0038] exist Figure 2In the example shown, lead 50 includes an electrode 60 located at its distal end 54. Processor 24 also controls stimulation generator 21 to generate stimulation signals and apply them to selected combinations of electrodes of the electrode module. In some examples, stimulation generator 21 includes a switching module that couples the stimulation signal to selected conductors within lead 50, thereby transmitting the stimulation signal across selected electrodes. Such a switching module can be a switch array, switch matrix, multiplexer, or any other type of switching module configured to selectively couple stimulation energy to selected electrodes and selectively sense bioelectrical neural signals of the spine using the selected electrodes.

[0039] However, in other examples, the stimulus generator 21 does not include a switching module. In these examples, the stimulus generator 21 includes multiple pairs of voltage sources, current sources, voltage absorbers, or current absorbers connected to each electrode in the electrodes, such that each pair of electrodes has a unique signal generator. In other words, in these examples, each electrode in the electrodes is independently controlled via its own signal generator (e.g., via a combination of regulated voltage sources and absorbers or regulated current sources and absorbers), which is the opposite of signal switching between electrodes.

[0040] The stimulation generator 21 can be a single-channel or multi-channel stimulation generator. Specifically, the stimulation generator 21 may be able to deliver a single stimulation pulse or multiple stimulation pulses 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, the stimulation generator 21 may be configured to deliver multiple channels on a time-staggered basis. For example, a switching module of the stimulation generator 21 may be used to time-divide the output of the stimulation generator 21 across different electrode combinations at different times to deliver multiple programs or channels of stimulation energy to the patient 40. In another example, the stimulation generator 21 may control independent sources or absorbers on a time-staggered basis.

[0041] Lead 50 may include a distal end 54 comprising a complex electrode array geometry having one or more segmented electrodes along a longitudinal axis, but in other examples may also include one or more single ring electrodes along the longitudinal axis. It should be understood that, as used herein, “along a longitudinal axis” refers to an axial position along the length of the longitudinal axis that can be radially displaced from that axis. In one example, the distal end 54 of lead 50 includes a plurality of electrodes 60 positioned at different axial locations along the longitudinal axis of the lead and a plurality of electrodes 60 positioned at different angular locations around the circumference / longitudinal axis of the lead (these may be referred to as electrode segments). Thus, electrodes can be selected along the longitudinal axis of lead 50 and along the circumference of lead 50. Selective activation of the electrodes 60 of lead 50 can generate a customizable stimulation field that can be directed to a specific side of lead 50 to isolate the stimulation field around a target anatomical region of brain 49. Figure 3 In the example, lead 50 includes two ring electrodes 68, 62, wherein each of the two segmented electrode rings 64, 66 has three segmented electrodes between the respective electrodes 68, 62 (e.g., Figure 3 The segmented electrodes 64A, 64B, 66A, and 66B are shown. The techniques described herein can be applied to leads having more or fewer segmented electrodes within segmented electrode rings and / or to leads having more or fewer than two segmented electrode rings. These techniques can also be applied to leads having more or fewer than two ring electrodes. In other cases, lead 50 may include only segmented electrodes or only ring electrodes. In some examples, lead 50 may include a tip electrode, which may be in the shape of a rounded cone or other shape residing at the distal tip of lead 50.

[0042] Although sensing module 22 and Figure 2 In some examples, the stimulation generator 21 and processor 24 are integrated into a common housing, but in others, the sensing module 22 may be located in a separate housing from the IMD 20 and may communicate with the processor 24 via wired or wireless communication technologies. Exemplary bioelectrical signals include, but are not limited to, signals generated from local field potentials in one or more regions of the spine or brain.

[0043] Sensor 25 may include one or more sensing elements that sense corresponding patient parameter values. For example, sensor 25 may include one or more accelerometers, optical sensors, chemical sensors, temperature sensors, pressure sensors, or any other type of sensor. Sensor 25 may output patient parameter values ​​that can be used as feedback to control therapy delivery. IMD 20 may include additional sensors within the housing of IMD 20 and / or coupled as a separate module via lead 50 or one of other leads. Furthermore, IMD 20 may wirelessly receive sensor signals from remote sensors, for example, via telemetry module 23. In some examples, one or more of these remote sensors may be located outside the patient's body (e.g., carried on an outer surface of the skin, attached to clothing, or otherwise positioned outside the patient's body).

[0044] Under the control of processor 24, telemetry module 23 supports wireless communication between IMD 20 and an external programmer (e.g., programmer 30) or another computing device. As updates to the program, processor 24 of IMD 20 can receive values ​​of various stimulation parameters (such as amplitude and electrode combinations) from programmer 30 via telemetry module 23. Updates to the therapy program can be stored in the therapy program 27 portion of memory 26. Telemetry module 23 in IMD 20, as well as telemetry modules in other devices and systems described herein (such as programmer 30), can communicate via radio frequency (RF) communication technology. Furthermore, telemetry module 23 can communicate with external medical device programmer 30 via proximal sensing interaction between IMD 20 and programmer 30. Therefore, telemetry module 23 can continuously, periodically, or upon request from IMD 20 or programmer 30.

[0045] Power source 29 delivers operating power to various components of IMD 20. Power source 29 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 20. In some examples, the power requirement may be small enough to allow IMD 20 to utilize patient movement and implement kinetic energy clearance devices to trickle charge the rechargeable battery. In other examples, conventional batteries may be used for a limited time period.

[0046] Figure 3 This is a conceptual diagram illustrating an exemplary medical lead 50. Figure 3In one example, there are eight conductors corresponding to eight corresponding electrodes (two ring electrodes and six segmented electrodes) and eight electrical terminals, such that lead 50 defines eight isolated electrical paths or channels for delivering therapeutic and / or sensing electrical signals via IMD20. However, in other examples, more or fewer conductors, electrodes, and terminals may be used. Lead 50 includes a distal end 54 and a proximal end 52, corresponding to the electrode end and terminal end, respectively. The distal end 54 and proximal end 52 may define a longitudinal axis 70 along the length of lead 50. Lead 50 includes an outer periphery 78 having a diameter 77. In some examples, the diameter 77 of the outer periphery 78 may be between approximately 25 milliliters (mil) and 100 mil, although other values ​​are also contemplated.

[0047] Lead 50 may include a lead body 72 extending between a distal end 54 and a proximal end 52. Lead body 72 may be configured to provide structure and support to lead 50 and encapsulate at least a portion of a plurality of conductors 74. At least a portion of lead body 72 may include conductors arranged in a coiled manner. In some examples, lead body 72 may serve as an insulator between the plurality of conductors 74. In some examples, lead body 72 may extend as a monolithic sheet along the length of lead 50. Lead body 72 may be formed of a polymeric material, including but not limited to polyurethane, silicone, fluoropolymers, fluoroelastomers, polyethylene, polyester, and other biocompatible polymers suitable for contact with body tissue.

[0048] The lead 50 may include a plurality of terminals 76 near the proximal end 52. Each of the plurality of terminals 76 may be configured to be electrically coupled to a conductor 74 within the lead body 72 of the lead 50 and a conductor outside the lead 50, such as... Figure 1 The contacts of IMD 20. A plurality of terminals 76 may be located at or near the proximal end 52 of lead 50. In some examples, each of the plurality of terminals 76 may be an annular contact extending around the outer periphery 78 of lead 50.

[0049] Lead 50 may include a plurality of electrical conductors 74 extending around a longitudinal axis 70 of lead 50. The plurality of electrical conductors 74 may be electrically isolated from each other through lead body 72 to form individual channels, circuits, or conductive paths through lead body 72, but the techniques described herein are also applicable to lead body 72 carrying a single conductor. Figure 3As shown, a plurality of conductors 74 may be arranged in a coiled configuration for at least a portion of the lead 50 (e.g., between the electrode 60 and the terminal 76). The coiled arrangement of the plurality of conductors 74 may be wound around the longitudinal axis 70 of the lead 50. In some examples, the plurality of electrical conductors 74 may include an electrically insulating sheath surrounding the conductive portion. The electrically insulating sheath may be configured to electrically insulate the conductors 74 from unwanted contact with electrodes or terminals not intended to make electrical contact with the conductors 74. In some examples, with or without the electrically insulating sheath, each of the plurality of electrical conductors 74 may have a diameter between at least about 0.0025 inches and about 0.0080 inches.

[0050] Each of the plurality of electrical conductors 74 may have a distal connection portion at its distal end and a proximal connection portion at its proximal end. The distal and proximal connection portions may be configured to electrically couple each of the plurality of electrical conductors 74 to a corresponding electrode in a plurality of electrodes 60 and a corresponding terminal in a plurality of terminals 76. In some examples, the distal and proximal connection portions may include connecting sleeves surrounding the periphery of the respective conductor, wherein the diameter of each connecting sleeve may be greater than, less than, or equal to the diameter of the remaining conductor body of the respective conductor. In some examples, such as for conductors having the aforementioned electrical insulating sheath, the plurality of conductors 74 may not have distal or proximal connection portions including connecting sleeves. For example, the distal portion of the electrical insulating sheath of the conductor may be removed to expose a bare metal conductor. This bare metal conductor may be used as a distal connection portion to electrically contact an electrode or terminal. Each of the plurality of electrodes 60 may be formed of a conductive material, including but not limited to platinum, palladium, iridium, titanium and titanium alloys (such as titanium-molybdenum alloy (TiMoly)), nickel and nickel alloys (such as MP35N alloy), etc. For example, the electrode may be formed of an 80 / 20 platinum / iridium alloy suitable for mechanical crimping.

[0051] Lead 50 may include a plurality of electrodes 60 near the distal end 54. Figure 3In the example, the plurality of electrodes 60 includes ring electrodes 62 and 68, and segmented electrodes, such as segmented electrodes 64A, 64B, 66A, and 66B. Although only segmented electrodes 64A, 64B, 66A, and 66B are shown, the segmented electrodes may form a discontinuous conductive ring comprising a plurality of electrodes, such as 64A, 64B, and an exemplary front electrode 64C (not shown) for three segmented electrodes on one ring (collectively referred to as “segmented electrode ring 64”), and 66A, 66B, and a front electrode 66C (not shown) on another ring (collectively referred to as “segmented electrode ring 66”). Each segmented electrode of a corresponding discontinuous segmented electrode ring is electrically isolated from the other segmented electrodes in that corresponding discontinuous segmented electrode ring. For example, segmented electrodes 64A and 64B, which are part of discontinuous segmented electrode ring 64, are electrically isolated from each other. In this example, at the distal end 54 of lead 50, there are two sets of three segmented electrodes forming segmented electrode rings 64 and 66, such that each set of segmented electrodes forming segmented electrode rings 64 and 66 is aligned along the longitudinal axis of the electrode module and these sets are circumferentially positioned around the outer periphery 78 of lead 50. In other examples, one or more segmented electrodes may be positioned along the longitudinal axis without being arranged symmetrically about the longitudinal axis. For example, a single segment with a span between 90 degrees and 120 degrees may be the only electrode at a specific axial position along the length of the lead, such that there is no radial symmetry.

[0052] The plurality of electrodes 60 of the lead 50 can be configured in a variety of different designs. For example, one or more leads 50 may include two or more electrodes at each longitudinal location along the length of the lead, such as multiple electrodes at different peripheral locations around the outer periphery 78 of the lead 50, such as by using an electrode module. As described above, each of the plurality of electrodes 60 may be electrically coupled to a corresponding electrical conductor among a plurality of electrical conductors 74. Each of the plurality of electrodes 60 may be formed of a biocompatible conductive material, including but not limited to platinum, palladium, iridium, and other biocompatible materials suitable for contact with body tissue. For example, the electrode may be formed of a 90 / 10 platinum / iridium alloy.

[0053] See Figures 1 to 3 As mentioned above, in some examples, clinicians may want to know the orientation and / or location of the lead 50. For example, when programming the IMD 20 using the programmer 30 to deliver electrical stimulation to the patient 40 via the electrode 60 of the lead 50, clinicians may want to know the orientation and / or location of the lead 50.

[0054] According to one or more techniques disclosed herein, the therapeutic system 10 may include a lead detection system 102 that can be configured to determine the orientation and / or location of the lead 50 when implanted in the patient 40. Figure 1As shown, the lead detection system 102 can determine the orientation and / or position of the lead 50 based on image data captured by the imaging device 100.

[0055] Imaging device 100 may represent any device capable of capturing images of a patient. Examples of imaging device 100 include, but are not limited to, x-ray imaging devices, computed tomography (CT) imaging devices, magnetic resonance imaging (MRI) devices, ultrasound imaging devices, and any other type of imaging device. In one specific example, imaging device 100 includes an O-arm purchased from Medtronic Inc. TM Imaging system. In some examples, imaging device 100 is capable of generating image data with a resolution of at least (1.0mm × 1.0mm × 1.0mm), (0.6mm × 0.6mm × 0.6mm), (0.4mm × 0.4mm × 0.4mm), ..., (0.1mm × 0.1mm × 0.1mm), or any other resolution suitable for imaging lead 50.

[0056] Imaging device 100 can provide image data corresponding to the captured image to other components of system 10, such as lead detection system 102. Imaging device 100 can provide image data in any suitable format. Exemplary formats include, but are not limited to, Analyze, the Neuroimaging Informatics Technology Initiative (Nifti), Minc, and Digital Imaging and Communications in Medicine (Dicom).

[0057] Lead detection system 102 can represent a system configured to analyze image data to determine the orientation and / or location of a lead implanted in a patient. Figure 1 In one example, the lead detection system 102 can analyze image data generated by the imaging device 100 to determine the orientation and / or location of the lead 50 after it has been implanted into the patient 40.

[0058] The lead 50 may include various features to facilitate the lead detection system 102 in determining its orientation and / or location. For example, such as Figure 3 As shown in the example, lead 50 may include orientation markers 82A and 82B (collectively referred to as "orientation marker 82"). Orientation marker 82 may be located at a specific position within lead 50 relative to electrode 60, such that the rotational orientation of orientation marker 82 is a function of the rotational orientation of electrode 60. Additionally, in some examples, orientation marker 82 may be positioned at one or more specific distances along longitudinal axis 70 from one or more electrodes of electrode 60. For example, orientation marker 82 may be positioned along longitudinal axis 70 from the farthest electrode (i.e., Figure 3 At a specific distance from electrode 62 in the middle.

[0059] In some examples, the orientation marker 82 can be positioned at different locations along the longitudinal axis 70. For example, as... Figure 3 As shown, orientation marker 82A can be positioned closer to the tip of the distal end 54 than orientation marker 82B. Therefore, in some examples, orientation marker 82A may be referred to as the upper orientation marker, and orientation marker 82B may be referred to as the bottom or lower orientation marker. Positioning the orientation marker 82 at different locations along the longitudinal axis 70, as described below, enables the lead detection system 102 to determine a specific rotational orientation of the lead 50 (i.e., the opposite of determining two possible rotational orientations 180 degrees apart).

[0060] The orientation marker 82 may be formed of a material visible in an image captured by the imaging device 100. For example, the orientation marker 82 may be formed to include at least one of a radiopaque material, such as barium sulfate, a bismuth compound, or tungsten. The orientation marker 82 may be formed in a shape capable of determining the rotational orientation of the lead 50. Exemplary shapes include, but are not limited to, triangles, rectangles with windows, etc.

[0061] In operation, the lead detection system 102 may (e.g., from the imaging device 100) receive image data representing images of the patient 40 after the lead 50 has been implanted in the patient 40. Figure 4 Examples of images generated by imaging apparatus 100 according to one or more techniques of this disclosure, the images including lead 50 or at least visible parts of lead 50. Figure 4 As shown, image 400 can correspond to an implant in patient 40. Figure 3 Image of lead wire 50.

[0062] The lead detection system 102 may also receive, determine, or otherwise obtain one or more parameters of the lead 50. As an example, the lead detection system 102 may receive user input indicating the manufacturer and model of the lead 50. Based on the manufacturer and model of the lead 50, the lead detection system 102 may obtain various parameters of the lead 50, such as the number of electrodes on the lead, the distance between the alignment marker 82 and the electrode 60, the angle between the vectors connecting the centers (e.g., centroids) of the alignment marker 82 and the electrode 60, or any other parameter. Again, the lead detection system 102 may receive user input indicating various parameters of the lead 50, such as the distance between the alignment marker 82 and the electrode 60, the angle between the vectors connecting the centers of the alignment marker 82 and the electrode 60, or any other parameter.

[0063] The lead detection system 102 can analyze image data to determine the orientation and / or location of the lead 50. For example, the lead detection system 102 can identify the corresponding location (e.g., centroid) of the electrode 60 and the corresponding location of the orientation marker 82. Figure 4 As shown, the lead detection system 102 can identify the centroid 82A' of orientation marker 82A, the centroid 82B' of orientation marker 82B, the centroid 62' of electrode 62, the centroid 64' of electrode 64, the centroid 66' of electrode 66, and the centroid 68' of electrode 68 (segmented electrodes 64A and 64B are clustered into a single electrode in image 400 with centroid 64', and segmented electrodes 66A and 66B are clustered into a single electrode in image 400 with centroid 66').

[0064] The lead detection system 102 can use any combination of various techniques to determine the orientation and / or position of the lead 50 based on the identified locations of the electrode 60 and the orientation marker 82. In a first technique, the lead detection system 102 can determine the axis of the electrode 50 based on the position of the electrode 60. For example, the lead detection system 102 can determine the axis corresponding to... Figure 3 The orientation of the longitudinal axis 70' of the longitudinal axis 70 is determined (e.g., parameters of the vector corresponding to the longitudinal axis 70' are determined). The lead detection system 102 can determine a plane orthogonal to the determined axis and project the position of the orientation marker 82 onto the determined plane.

[0065] Figure 5 This is a conceptual diagram showing the projection of the position of an orientation marker according to one or more techniques of this disclosure onto a plane orthogonal to the longitudinal axis of the lead. (As shown) Figure 5 As shown, the lead detection system 102 can define plane 86 as a plane orthogonal to the longitudinal axis 70'. Figure 4 The positions of the centroids 82A' and 82B' (corresponding to the positions of the orientation markers 82A and 82B, respectively) are projected onto plane 86 as projected centroids 82A' and 82B'. Figure 5 In the diagram, the point located at (0.0, 0.0) corresponds to the point along the longitudinal axis 70'.

[0066] The lead detection system 102 can determine the rotational orientation of the lead 50 based on the projected centroids 82A” and 82B”. For example, the lead detection system 102 can calculate the vector 84 of the projected centroids 82A” and 82B” in the connecting plane 86. The vector 84 can represent the rotational orientation of the orientation marker 82, and therefore the rotational orientation of the lead 50.

[0067] Additionally, as described above, the orientation marker 82 may be located at a specific position within the lead 50 relative to the electrode 60, such that the rotational orientation of the orientation marker 82 is a function of the rotational orientation of the electrode 60. Therefore, since vector 84 represents the rotational orientation of the orientation marker 82, the lead detection system 102 can determine the rotational orientation of the electrode 60 based on vector 84. For example, based on information about the lead 50 (e.g., model), the lead detection system 102 can obtain the angular offset between vector 84 and the electrode center of the electrode 60. As a specific example, the lead detection system 102 can obtain an angular offset 88 representing the angle between the center (e.g., centroid) of electrode segment 64A and vector 84. Based on the obtained angular offset, the lead detection system 102 can determine the vector from the center of one or more electrodes in the electrode 60.

[0068] In a second technique for determining the orientation and / or position of lead 50 based on the identified locations of electrode 60 and orientation marker 82, lead detection system 102 may obtain a predetermined template of the expected centroids of electrode 60 and orientation marker 82. The predetermined template may be located in a fixed lead-based coordinate system. The template may represent the size, shape, and / or radial and longitudinal spacing of the electrodes, and may also represent the size, shape, and / or radial and longitudinal spacing of the markers. The template may be referred to as a template model. Lead detection system 102 may determine a transformation between the centroids determined from the image and the centroids in the template. For example, lead detection system 102 may use singular value decomposition (SVD) to determine a best-fit rigid transformation between the centroids in the template and the corresponding centroids 82A', 82B', 62', 64', 66', and 68'. Based on the determined transformation, lead detection system 102 may determine the orientation of lead 50. Any type of transformation that can express the spatial relationship between two sets of centroids may be used.

[0069] In some examples, the lead detection system 102 may use either a first technique or a second technique to determine the orientation of the lead 50. In other examples, the lead detection system 102 may use a combination of the first and second techniques to determine the orientation of the lead 50. For example, the lead detection system 102 may use either a first technique or a second technique to determine the orientation of the lead 50, and use the other of the first or second technique to confirm the determined orientation.

[0070] Figure 6A and Figure 6B This is a conceptual diagram illustrating an exemplary model of leads according to one or more technologies disclosed herein. Figure 6A An exemplary two-dimensional model of the lead 50 in a plane orthogonal to the longitudinal axis 70 is shown. Figure 6B An exemplary three-dimensional model of the lead 50 is shown. Figure 6A and Figure 6BThe model shown can be located in a virtual coordinate system.

[0071] Figure 7A and Figure 7B This is an exemplary visual concept diagram illustrating leads according to one or more technologies in accordance with this disclosure. Figure 7A An exemplary visualization of lead 50 in the xy plane is shown. Figure 7B An exemplary visualization of the lead 50 after the longitudinal axis 70 is rotated along the z-axis is shown. Figure 7A and Figure 7B The visualization can correspond to Figure 4 The image shown.

[0072] As described herein, the system can determine the orientation of the lead based on images of the lead as it is implanted in the patient's body. For example, the lead detection system 102 can process... Figure 4 The image shown is used to determine the orientation of lead 50. Figure 4 The image shown represents the data actually received by the lead detection system 102, while Figure 7A and Figure 7B The visualization can represent the concept. Furthermore, as mentioned above, the lead detection system 102 can determine the rotational orientation by determining the transformation between the features of the lead model and the features of the lead image. Figure 7A and Figure 7B In the example, the lead detection system 102 can determine Figure 6A and Figure 6B The transformation between the models, and the lead 50 roll 177.96°, pitch 2.32° and yaw -145.64°.

[0073] Figure 8 These are exemplary images generated by an imaging device for implanted leads within a patient's body, according to one or more techniques of this disclosure. Figure 8 The image is similar to Figure 4 The image (e.g., an image with the same leader), however the leader in the image is tilted.

[0074] Figure 9A and Figure 9B This is an exemplary visual concept diagram illustrating leads according to one or more technologies in accordance with this disclosure. Figure 9A An exemplary visualization of lead 50 in the xy plane is shown. Figure 9B An exemplary visualization of the lead 50 after the longitudinal axis 70 is rotated along the z-axis is shown. Figure 9A and Figure 9B The visualization can correspond to Figure 8 The image shown.

[0075] As described herein, the system can determine the orientation of the lead based on images of the lead as it is implanted in the patient's body. For example, the lead detection system 102 can process... Figure 8 The image shown is used to determine the orientation of lead 50. Figure 8 The image shown represents the data actually received by the lead detection system 102, while Figure 9A and Figure 9B The visualization can represent the concept. Furthermore, as mentioned above, the lead detection system 102 can determine the rotational orientation by determining the transformation between the features of the lead model and the features of the lead image. Figure 9A and Figure 9B In the example, the lead detection system 102 can determine Figure 6A and Figure 6B The transformation between the models, and the lead line 50 rolls 167.39°, pitches -11.81° and yaws -142.78°.

[0076] Figure 10 This is a functional block diagram illustrating the components of the lead detection system 102. Examples of the lead detection system 102 include, but are not limited to, desktop computers, tablets, laptops, mainframes, cloud computing environments, servers, or any other type of computing system. As a specific example, the lead detection system 102 may be a StealthStation, available from Medtronic. TM S8. In Figure 10 In the example, the lead detection system 102 includes processor circuitry 124 (also referred to as a “processor”), memory 126, and communication module 128. Each of these components (also referred to as a “module”) may be or may include circuitry configured to perform the functions belonging to each respective module.

[0077] Processor 124 may include one or more of the following: microprocessor, controller, digital signal processor (DSP), application-specific integrated circuit (ASIC), field-programmable gate array (FPGA), discrete logic circuit, or any other processing circuit configured to provide functions attributable to processor 124, and processor may be embodied herein as firmware, hardware, software, or any combination thereof.

[0078] Memory 126 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), flash memory, etc. Memory 126 may store computer-readable instructions that, when executed by processor 124, cause lead detection system 102 to perform various functions. Memory 126 may be a storage device or other non-transitory medium. Figure 10As shown, memory 126 can store lead detection module 140 and lead parameters 150.

[0079] Lead parameters 150 may include various parameters relating to the lead, such as lead 50. Examples of parameters that may be included in lead parameters 150 include, but are not limited to, lead model (e.g., CAD model, template model, etc.), center coordinates of the lead's orientation marker and the electrode, distance between the lead's orientation marker and the electrode, angle between the vectors connecting the centers of the orientation marker and the electrode, or any other parameter. In some examples, lead parameters 150 may include corresponding sets of lead parameters for different lead models. For example, lead parameters 150 may include a first set of lead parameters for a first lead model and a second set of lead parameters for a second lead model.

[0080] Communication module 142 can communicate with external devices via one or more wired and / or wireless networks by transmitting and / or receiving network signals on one or more networks. Examples of communication module 142 include network interface cards (e.g., such as Ethernet cards), optical transceivers, radio frequency transceivers, GPS receivers, or any other type of device capable of sending and / or receiving information. Other examples of communication module 142 may include shortwave radios, cellular data radios, wireless network radios, and Universal Serial Bus (USB) controllers.

[0081] According to one or more techniques of this disclosure, the lead detection module 140 can be executed by the processor 124 to detect leads implanted in the patient's body based on image data (e.g., imaged by an imaging device such as an imaging device). Figure 1 The imaging device 100 generates image data to determine the location and / or orientation of the lead implanted in the patient. The image data may represent a relatively small volume of interest containing the lead (e.g., a portion of the lead's carrier electrode and orientation marker). In some examples, the lead detection module 140 may perform preprocessing on the image data. For example, the lead detection module 140 may use linear interpolation to resample the volume of interest to a fixed voxel resolution (e.g., 0.1 mm × 0.1 mm × 0.1 mm).

[0082] The lead detection module 140 can determine various parameters of the lead. As an example, the lead detection system 140 can receive a representation of user input indicating the manufacturer and model of the lead. Alternatively, the lead detection system 140 can receive a message indicating the manufacturer and model of the lead from the IMD (e.g., via a telemetry link). Based on the manufacturer and model, the lead detection module 140 can query the lead parameter 150 to determine the parameters of the lead.

[0083] The lead detection module 140 can analyze image data to identify the centroids of electrodes and orientation markers. For example, the lead detection module 140 can select a threshold and use the selected threshold to identify the centroids. In some examples, the lead detection module 140 can adaptively select the threshold. For example, the lead detection module 140 can sort all intensities of the image and select the Nth highest intensity as the threshold (e.g., such that N = V_Electrodes / One_Voxel_volume, where One_Voxel_Volume is the volume of a single voxel, and V_Electrodes (e.g., 3.5 mm)). 3 (where V_Electrodes is the volume of the electrode). Therefore, the lead detection module 140 can select the brightest voxel with a specific fixed volume V_Electrodes as the potential electrode. In some examples, the lead detection module 140 can obtain the value of V_Electrodes from the lead parameter 150. In other examples, the lead detection module 140 can use a fixed value for V_Electrodes for all lead pairs.

[0084] The lead detection module 140 can apply a selected threshold to image data to identify the location of the electrode centroids. For example, the lead detection module 140 can identify voxel connection parts with an intensity greater than (or equal to) the threshold and determine the centroid of each part (weighted by image intensity). If the lead in the image includes X electrodes, the lead detection module 140 can identify X centroids corresponding to each of the X electrodes. In some examples, the lead detection module 140 may generate an error if more or fewer centroids are identified. For example, if the lead includes four electrodes, the lead detection module 140 may generate an error if applying the selected threshold results in more or fewer than four centroids.

[0085] In the event of an error generated by the lead detection module 140, the lead detection module 140 may use any suitable technique to output an indication of the error. For example, the lead detection module 140 may cause the output device 144 to display a graphical representation of the error (e.g., an error message).

[0086] The lead detection module 140 can use any suitable technique to identify the centroid. As an example, the lead detection module 140 can identify the centroid of a specific connection part (e.g., an electrode or marker) as a voxel corresponding to the arithmetic mean position of all voxels in the connection part.

[0087] In some examples, the lead detection module 140 can identify the initial position of the centroid and refine the initial position using various techniques. For example, based on the assumption that the centroid of the electrode should lie on a line, the lead detection module 140 can refine the position of the centroid to fit a line. As an example, the lead detection module 140 can apply singular value decomposition (SVD) to the initial centroid to find the best linear fit and modify the initial position to fit the identified line.

[0088] The lead detection module 140 can identify the position of the orientation marker based on the identified position of the electrode. For example, the lead detection module 140 can mask (e.g., set to zero) voxels within a radius (e.g., 1.0 mm, 1.5 mm, 2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, etc.) surrounding the centroid of each electrode. The lead detection module 140 can determine the center of all determined centroids (i.e., the average of their positions) and mask all voxels outside a ring at a certain distance from that center (e.g., masking all voxels less than 7 mm or greater than 18 mm from the center of all electrodes). Masking voxels can be effective because the marker is expected to be visible within that ring.

[0089] The lead detection module 140 can use an adaptive threshold to threshold the remaining visible voxels. Therefore, the lead detection module 140 can select markers with a specific fixed volume V_markers (e.g., 1.4 mm). 3 The brightest voxel is used as a potential marker. In some examples, the lead detection module 140 may obtain the value of V_markers from the lead parameter 150. In other examples, the lead detection module 140 may use a fixed value for V_markers for all lead pairs.

[0090] The lead detection module 140 can use marker thresholding to threshold an image and identify connected components in the thresholded image. While a lead may include multiple (e.g., two) orientation markers, at this stage the markers may appear as a single component (e.g., due to the proximity of the markers). The lead detection module 140 can identify the largest component by volume. If the volume of the identified largest component is smaller than a certain value expected from two merged markers (e.g., less than 1.3 mm), then the module can detect the connection. 3 If the lead detection module 140 can add the component with the next largest volume to the first component (e.g., based on the assumption that the next largest volume is the second marker), then the lead detection module 140 can identify the (strength-weighted) centroid of the identified component.

[0091] After performing the above techniques, the lead detection module 140 may have identified a linear fit with the electrode centroid, but may not yet have identified which electrodes are closer to the proximal side and which are farther to the distal side. The lead detection module 140 may determine (e.g., based on lead parameter 150) that the orientation marker should be closer to the proximal electrode (e.g., ...). Figure 3 Electrode 68). To identify which electrodes are closer to the front and which are farther to the back, lead detection module 140 can project the centroid of the electrodes onto a vector representing the electrode fitting line. This projection results in a single number being assigned to each electrode. Lead detection module 140 can also project the centroid of an orientation marker onto the same line, producing another number. If the marker projection is not greater than the projections of all electrodes, lead detection module 140 can reverse the direction of the line fitting vector. Therefore, lead detection module 140 can ensure that the vector originates from the farthest electrode (e.g., ...). Figure 3 Electrode 62) points to the nearest side electrode (e.g., Figure 3 Electrode 68).

[0092] The lead detection module 140 can determine a rotation matrix that rotates the electrode wire fitting vector to a specific axis (e.g., the "z-axis") so that it points in the positive direction of that axis. In some examples, the lead detection module 140 can use the Rodriguez rotation formula to calculate the rotation matrix while handling edge cases of gimbal locks.

[0093] The lead detection module 140 can rotate the coordinate system of the marker component according to the rotation matrix described above. The lead detection module 140 can apply a translation with the origin placed at the center of the marker. Therefore, it can be assumed that the voxel with the most positive coordinate on a specific axis (e.g., the most positive coordinate on the z-axis) belongs to a marker, and the voxel with the most negative coordinate on a specific axis (e.g., the most negative coordinate on the z-axis) belongs to a second marker. Specifically, the lead detection module 140 can identify all voxels with coordinates greater than a threshold distance (e.g., D) on a specific axis as first markers (e.g., ...). Figure 3 The marker 82A), and all voxels with negative values ​​(e.g., -D) at coordinates less than a threshold distance on a specific axis will be identified as the second marker (e.g., Figure 3 (Marker 82B). For example, the lead detection module 140 can identify the first marker as all voxels z>D and the second marker as all voxels z<-D, where D is a certain distance from the center of the marker, such as 0.41 mm.

[0094] The lead detection module 140 can identify the centroid (intensity-weighted centroid) of each marker in the array. For example, the lead detection module 140 can identify the centroid of the voxel identified as the first marker and the centroid of the voxel identified as the second marker.

[0095] The lead detection module 140 can determine the orientation of the lead using any combination of the identified centroid of the electrode, the identified centroid of the orientation marker, and the identified fitted line / vector direction. As described above, the lead detection module 140 can utilize a first technique involving determining the vector between the projections of the marker centroids, a second technique involving template matching of the identified centroids, or a combination of the first and second techniques.

[0096] In order to determine the orientation of the lead using the first technique, the lead detection module 140 can determine a plane orthogonal to the identified fitted line (e.g., ...). Figure 5 The plane 86). Since the identified fitted line represents the longitudinal axis 70 (i.e., the electrode axis), the determined plane can be approximately orthogonal to the longitudinal axis 70.

[0097] The lead detection module 140 can project the identified centroid of the orientation marker onto a defined plane. For example, as Figure 5 As shown, the lead detection module 140 can project the positions of centroids 82A' and 82B' (corresponding to the positions of orientation markers 82A and 82B, respectively) onto the plane 86 as projected centroids 82A' and 82B".

[0098] The lead detection module 140 can determine the vector that connects the first marker to the second marker. For example, such as Figure 5 As shown, the lead detection module 140 can calculate the vector 84 of the projected centroids 82A” and 82B” in the connecting plane 86. Vector 84 can represent the rotational orientation of the orientation marker 82, and therefore the rotational orientation of the lead 50. In this way, the lead detection module 140 can determine the rotational orientation of the lead.

[0099] In some examples, the lead detection module 140 can determine the rotational orientation of the various electrodes of the lead (e.g., in one or both of the patient coordinate system and the image coordinate system). For example, the lead detection module 140 can obtain various offset angles from the lead parameters 150. The offset angle can represent the angular offset between the vector between the orientation markers and the various electrode segments. As an example, the lead detection module 140 can obtain a first angle representing the offset between the vector between the orientation markers and the center of the first electrode segment (e.g., ...). Figure 3 The angle between the orientation markers 82A and 82B and the electrode segment 66A, and a second angle representing the offset between the vector between the orientation markers and the center of the second electrode segment (e.g., the angle between the orientation markers 82A and 82B and the electrode segment 66A). Figure 3The angles between the orientation markers 82A and 82B and the electrode segment 66B, ..., and the nth angle representing the offset between the vectors between the orientation markers and the center of the nth electrode segment. The lead detection module 140 can use the offset angle to determine various vectors that may be perpendicular to the longitudinal axis 70, which represent the direction in which the orientation electrode points.

[0100] To determine the orientation of the lead using a second technique, the lead detection module 140 obtains a predetermined template of the expected centroid of the lead electrode in the image. The predetermined template may be located in a fixed lead-based coordinate system. The lead detection module 140 can determine the transformation between the centroid determined from the image and the centroid in the template. For example, the lead detection module 140 can use SVD to determine the best-fit rigid transformation between the centroid in the template and the corresponding centroids 82A', 82B', 62', 64', 66', and 68'. Based on the determined transformation, the lead detection module 140 can determine the orientation of the lead.

[0101] Similar to the first technique, the obtained template can indicate the corresponding angle of each electrode segment in the electrode section. Therefore, based on the determined transformation, the lead detection module 140 can determine various vectors that can be perpendicular to the longitudinal axis 70, which represent the direction in which the directional electrode points.

[0102] Regardless of the specific technology used, the lead detection module 140 can generate outputs that include any combination of the following: the centroid of the distal electrode in voxel coordinates (3D point), the direction of the lead trajectory (from the distal electrode toward the proximal electrode (3D vector)), the direction of the center of the target electrode segment (3D vector, perpendicular to the lead trajectory), a confidence score (e.g., a value indicating the probability that other outputs are accurate), and one or more error codes.

[0103] The lead detection module 140 can provide output via any channel. As an example, the lead detection module 140 can cause the output device 144 to display a graphical representation of the lead over an image of a patient with the lead implanted. This graphical representation can show the orientation and / or position of the lead relative to the patient (e.g., relative to one or more anatomical structures of the patient). Alternatively, the lead detection module 140 can cause the output device 144 to display a numerical representation of any combination of the above outputs (e.g., the centroid of the distal electrode, the direction of the lead trajectory, the direction of the center of the target electrode segment).

[0104] Figure 11 This is a flowchart illustrating an exemplary technique for determining the orientation of a lead implanted in a patient, according to one or more techniques of this disclosure. For illustrative purposes, reference will be made to... Figure 1 Described in conjunction with the lead detection system 102 in Figure 6 Figure 11The technology. However, lead detection systems other than lead detection system 102 can perform... Figure 11 Some or all of the technologies.

[0105] The lead detection system 102 can acquire image data (702) representing the lead implanted in the patient's body. For example, the communication module 142 of the lead detection system 102 can acquire images of the area of ​​the patient 40 with the lead 50 implanted in the body from the imaging device 100. Figure 1 Computed tomography (CT) images of 40 patients. As described above, exemplary formats of image data include, but are not limited to, Analyze, the Neuroimaging Informatics Technology Initiative (Nifti), Minc, and Digital Imaging and Communications in Medicine (Dicom).

[0106] The lead detection system 102 can determine the corresponding positions of the electrodes of the lead based on image data (704). For example, the lead detection module 140 can be executed by the processor 124 to adaptively determine a threshold (e.g., based on the known number of electrodes included in the lead and the known volume of the electrodes), apply the determined threshold to the image data, identify the connecting parts in the thresholded image data, and identify the centroid of the connecting parts. The centroid of the connecting parts represents the position of the electrodes.

[0107] The lead detection system 102 can determine the orientation of the lead axis based on the position of the electrode (706). For example, the lead detection module 140 can be executed by the processor 124 to (e.g., using SVD) determine a linear fitting line to fit the identified centroid. As described above, the lead axis can correspond to Figure 3 The longitudinal axis of the lead wire 50 is 70.

[0108] The lead detection system 102 can determine the corresponding position (708) of the lead orientation marker based on image data. For example, the lead detection module 140 can be executed by the processor 124 to mask (e.g., set to zero) voxels in the image data corresponding to the electrode, adaptively determine a threshold (e.g., based on the known volume of the marker), apply the determined threshold to the image data, identify the connecting parts in the thresholded image data, and identify the centroid of the connecting parts. The centroid of the connecting parts represents the position of the orientation marker.

[0109] The lead detection system 102 can project the corresponding positions of the orientation markers onto a plane orthogonal to the longitudinal axis (710). For example, the lead detection module 140 can be executed by the processor 124 to calculate the plane (e.g., Figure 5 The plane 86), and the positions of the orientation markers 82A' and 82B' are projected onto the plane to obtain Figure 4 The projection positions are 82A and 82B.

[0110] The lead detection system 102 can determine the rotational orientation of the lead based on the projected position of the orientation markers (712). For example, the lead detection module 140 can be executed by the processor 124 to calculate the vector from the first marker of the orientation marker to the second marker of the orientation marker (e.g., Figure 5 Vector 84). As described above, vector 84 can represent the rotational orientation of the orientation marker 82, and therefore the rotational orientation of the lead 50.

[0111] The lead detection system 102 can output an indication of the determined rotational orientation. For example, the lead detection module 140 can be executed by the processor 124 to cause the output device 144 to display a graphical representation of the lead over an image of the patient with the implanted lead. This graphical representation can show the orientation and / or position of the lead relative to the patient. Alternatively, the lead detection module 140 can cause the output device 144 to display a numerical representation of any combination of the above outputs (e.g., the centroid of the distal electrode, the direction of the lead trajectory, the direction of the center of the target electrode segment).

[0112] The physician can program the operation of the IMD 20 using the determined rotational orientation of the leads (e.g., using a programmer 30). As an example, in cases where it is desired to deliver electrical stimulation therapy to a specific volume of a patient's brain (e.g., a specific activation volume), the physician can use the programmer 30 to program the IMD 30 to deliver electrical stimulation therapy via electrodes of the leads 50 that activate the specific volume.

[0113] Figure 12 This is a flowchart illustrating another exemplary technique for determining the orientation of a lead implanted in a patient, according to one or more techniques of this disclosure. For illustrative purposes, reference will be made to... Figure 1 Described in conjunction with the lead detection system 102 in Figure 6 Figure 12 The technology. However, lead detection systems other than lead detection system 102 can perform... Figure 12 Some or all of the technologies.

[0114] The lead detection system 102 can acquire image data (802) representing the lead implanted in the patient's body. For example, the communication module 142 of the lead detection system 102 can acquire images of the area of ​​the patient 40 with the lead 50 implanted in the body from the imaging device 100. Figure 1 Computed tomography (CT) images of 40 patients. As described above, exemplary formats of image data include, but are not limited to, Analyze, the Neuroimaging Informatics Technology Initiative (Nifti), Minc, and Digital Imaging and Communications in Medicine (Dicom).

[0115] The lead detection system 102 can determine the corresponding positions of the electrodes of the lead based on image data (804). For example, the lead detection module 140 can be executed by the processor 124 to adaptively determine a threshold (e.g., based on the known number of electrodes included in the lead and the known volume of the electrodes), apply the determined threshold to the image data, identify the connecting parts in the thresholded image data, and identify the centroid of the connecting parts. The centroid of the connecting parts represents the position of the electrodes.

[0116] The lead detection system 102 can determine the corresponding position of the lead orientation markers based on image data (806). For example, the lead detection module 140 can be executed by the processor 124 to mask (e.g., set to zero) voxels in the image data corresponding to the electrodes, adaptively determine a threshold (e.g., based on the known volume of the marker), apply the determined threshold to the image data, identify the connecting parts in the thresholded image data, and identify the centroid of the connecting parts. The centroid of the connecting parts represents the position of the orientation markers.

[0117] The lead detection system 102 can obtain a template model (808) corresponding to the lead. For example, the lead detection module 140 can be executed by the processor 124 to obtain a template model of the lead corresponding to the lead implanted in the patient's body in a fixed lead-based coordinate system from the lead parameters 150.

[0118] The lead detection system 102 can determine the transformation between the identified positions of the electrodes and markers and the corresponding positions of the electrodes and markers in the template model (810). For example, the lead detection module 140 can be executed by the processor 124 to calculate a three-dimensional rotation matrix that transforms the leads in the image data into leads in the template model. Specifically, the lead detection module 140 can calculate a 6-parameter 3D rigid body transformation between the identified centroids of the electrodes and markers and the centroids of the corresponding electrodes and markers in the template model.

[0119] The lead detection system 102 can determine the rotational orientation of the lead based on this transformation (812). For example, the lead detection module 140 can be executed by the processor 124 to identify the rotational orientation of the lead based on the Euler angle yaw in the transformation about the lead axis, where the lead axis is along the z-axis (e.g., longitudinal axis 70) in the lead coordinate system.

[0120] The lead detection system 102 can output an indication of the determined rotational orientation. For example, the lead detection module 140 can be executed by the processor 124 to cause the output device 144 to display a graphical representation of the lead over an image of the patient with the implanted lead. This graphical representation can show the orientation and / or position of the lead relative to the patient. Alternatively, the lead detection module 140 can cause the output device 144 to display a numerical representation of any combination of the above outputs (e.g., the centroid of the distal electrode, the direction of the lead trajectory, the direction of the center of the target electrode segment).

[0121] A physician can program the operation of the IMD 20 using the determined rotational orientation of the leads (e.g., using a programmer 30). For example, in cases where it is desired to deliver electrical stimulation therapy to a specific volume of a patient's brain (e.g., a specific activation volume), the physician can use the programmer 30 to program the IMD 30 to deliver electrical stimulation therapy via electrodes of the leads 50 that activate the specific volume.

[0122] While the techniques described above are primarily described as being executed by the processor 124 of the lead detection system 102, in other examples, one or more other processors may execute any part of the techniques described herein, either alone or in combination with processor 124. Therefore, the reference to “processor” may refer to “one or more processors.” Similarly, in different examples, “one or more processors” may refer to a single processor or multiple processors.

[0123] The techniques described in this disclosure, including those attributed to lead detection system 102 or its various components, can be implemented at least in part in hardware, software, firmware, or any combination thereof. For example, aspects of these techniques can be implemented within one or more processors, including one or more microprocessors, DSPs, ASICs, FPGAs, or any other equivalent integrated or discrete logic circuits, and any combination of such components, embodied in a programmer, such as a clinician or patient programmer, medical device, or other device.

[0124] In one or more examples, the functionality described in this disclosure may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functionality may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. The computer-readable medium may include a computer-readable storage medium forming a tangible, non-transitory medium. The instructions may be executed by one or more processors, such as one or more DSPs, ASICs, FPGAs, general-purpose microprocessors, or other equivalent integrated or discrete logic circuits. Therefore, the term "processor" as used herein may refer to one or more of the foregoing structures or any other structures suitable for implementing the techniques described herein.

[0125] Furthermore, in some aspects, the functionality described herein may be provided within dedicated hardware and / or software modules. 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 may be performed by separate hardware or software components, or integrated within common or separate hardware or software components. Additionally, this technology may be fully implemented in one or more circuit or logic elements. The technology disclosed herein can be implemented in a variety of devices or apparatuses, including IMDs, external programmers, combinations of IMDs and external programmers, integrated circuits (ICs) or a set of ICs and / or discrete circuits residing in IMDs and / or external programmers.

[0126] The following numbered embodiments illustrate one or more aspects of this disclosure:

[0127] Example 1. A method comprising: obtaining an image of a lead implanted in a patient, the lead including one or more electrodes positioned along a longitudinal axis of the lead and a plurality of orientation markers; determining corresponding positions of the one or more electrodes and corresponding positions of the plurality of orientation markers in the image; determining an orientation of the longitudinal axis based on the corresponding positions of the one or more electrodes; projecting the corresponding positions of the orientation markers onto a plane orthogonal to the longitudinal axis; and determining a rotational orientation of the lead based on the projected position of a first orientation marker among the plurality of orientation markers in the plane and the projected position of a second orientation marker among the plurality of orientation markers in the plane.

[0128] Example 2. According to the method of Example 1, determining the corresponding position of the electrode and the corresponding position of the orientation marker includes determining the corresponding position of the centroid of the electrode and the corresponding position of the centroid of the orientation marker.

[0129] Example 3. The method according to any one of Examples 1 or 2, wherein one or more electrodes comprise a plurality of electrodes positioned at different angular locations around a longitudinal axis.

[0130] Example 4. The method according to any combination of Examples 1 to 3 further includes: identifying a first orientation marker and a second orientation marker in an image, wherein determining the rotational orientation of the lead includes: determining a vector connecting the first orientation marker and the second orientation marker; and determining the rotational orientation of the lead based on the vector.

[0131] Example 5. The method according to Example 4 further includes: obtaining a predetermined offset angle between the vector and one or more electrodes; and adding the predetermined offset angle to the determined vector to determine the rotational orientation of the electrodes.

[0132] Example 6. The method according to any combination of Examples 1 to 5, wherein determining the orientation of the longitudinal axis comprises: determining the best-fit line based on the determined position of the electrodes.

[0133] Example 7. The method according to any combination of Examples 1 to 6, wherein the leads include segmented leads and one or more electrodes are configured to deliver electrical stimulation therapy.

[0134] Example 8. The method according to any combination of Examples 1 to 7 further includes: determining the number of electrodes included in one or more electrodes; determining the number of determined locations of one or more electrodes; determining that the number of determined locations of one or more electrodes is different from the number of electrodes; and outputting an error in response to determining that the number of determined locations is different from the number of electrodes included in one or more electrodes.

[0135] Example 9. The method according to any combination of Examples 1 to 8 further includes: obtaining a template model of the lead; and determining a transformation between the determined positions of one or more electrodes and a plurality of orientation markers and the positions of the corresponding electrodes and orientation markers in the template model, wherein determining the rotational orientation of the lead further includes: determining the rotational orientation of the lead based on the transformation.

[0136] Example 10. A system comprising: a memory; and processing circuitry configured to perform the method according to any combination of Examples 1 to 9.

[0137] Example 11. A system comprising means for performing the method according to any combination of Examples 1 to 9.

[0138] Example 12. A computer-readable storage medium storing instructions that, when executed, cause one or more processors to perform the method according to any combination of Examples 1 to 9.

[0139] Example 13. A method comprising: obtaining an image of a lead implanted in a patient, the lead including one or more electrodes and a plurality of orientation markers positioned along a longitudinal axis of the lead; determining corresponding positions of the electrodes and corresponding positions of the orientation markers in the image; obtaining a template model corresponding to the lead; determining a transformation between the determined positions of the one or more electrodes and the plurality of orientation markers and the positions of the corresponding electrodes and orientation markers in the template model; and determining a rotational orientation of the lead based on the transformation.

[0140] Example 14. According to the method of Example 13, determining the corresponding position of the electrode and the corresponding position of the orientation marker includes determining the corresponding position of the centroid of the electrode and the corresponding position of the centroid of the orientation marker.

[0141] Example 15. The method according to any one of Examples 13 or 14, wherein one or more electrodes comprise a plurality of electrodes positioned at different angular locations around a longitudinal axis.

[0142] Example 16. The method according to any combination of Examples 13 to 15, wherein the leads include segmented leads and one or more electrodes are configured to deliver electrical stimulation therapy.

[0143] Example 17. The method according to any combination of Examples 13 to 16 further includes: determining the orientation of the longitudinal axis.

[0144] Example 18. The method according to Example 17 further includes: projecting the corresponding positions of the orientation markers onto a plane orthogonal to the longitudinal axis, wherein determining the rotational orientation of the lead further includes: determining the rotational orientation of the lead based on the projection position of the first orientation marker among the plurality of orientation markers in the plane and the projection position of the second orientation marker among the plurality of orientation markers in the plane.

[0145] Example 19. The method according to Example 18 further includes: identifying a first orientation marker and a second orientation marker in an image, wherein determining the rotational orientation of the lead includes: determining a vector connecting the first orientation marker and the second orientation marker; and determining the rotational orientation of the lead based on the vector.

[0146] Example 20. The method according to Example 19 further includes: obtaining a predetermined offset angle between the vector and one or more electrodes; and adding the predetermined offset angle to the determined vector to determine the rotational orientation of the electrodes.

[0147] Example 21. The method according to any combination of Examples 13 to 20, wherein determining the orientation of the longitudinal axis comprises: determining the best-fit line based on the determined positions of one or more electrodes.

[0148] Example 22. A system comprising: a memory; and processing circuitry configured to perform the method according to any combination of Examples 13 to 21.

[0149] Example 23. A system comprising means for performing the method according to any combination of Examples 13 to 21.

[0150] Example 24. A computer-readable storage medium storing instructions that, when executed, cause one or more processors to perform the method according to any combination of Examples 13 to 21.

[0151] Various examples of this disclosure have been described. These and other embodiments are within the scope of the following claims.

Claims

1. A system for determining the orientation and / or location of a lead implanted in a patient, comprising: Memory; and The processing circuit is configured as follows: Obtain an image of a lead implanted in a patient, the lead including one or more electrodes positioned along the longitudinal axis of the lead and a plurality of orientation markers; The corresponding positions of the one or more electrodes and the corresponding positions of the plurality of orientation markers are determined in the image; The orientation of the longitudinal axis is determined based on the respective positions of the one or more electrodes; The corresponding positions of the orientation markers are projected onto a plane orthogonal to the longitudinal axis; as well as The rotational orientation of the lead is determined based on the projection position of the first orientation marker among the plurality of orientation markers in the plane and the projection position of the second orientation marker among the plurality of orientation markers in the plane.

2. The system of claim 1, wherein, in order to determine the corresponding position of the electrode and the corresponding position of the orientation marker, the processing circuit is configured to determine the corresponding position of the centroid of the electrode and the corresponding position of the centroid of the orientation marker.

3. The system of claim 1, wherein the one or more electrodes comprise a plurality of electrodes positioned at different angular locations around the longitudinal axis.

4. The system according to claim 1, wherein the processing circuit is further configured as follows: identifying the first orientation marker and the second orientation marker in the image, wherein, To determine the rotational orientation of the lead, the processing circuit is configured to: Determine the vector connecting the first orientation marker and the second orientation marker; as well as The rotational orientation of the lead is determined based on the vector.

5. The system according to claim 4, wherein the processing circuit is further configured to: Obtain the predetermined offset angle between the vector and one or more of the electrodes; and The predetermined offset angle is added to the determined vector to determine the rotational orientation of the electrode.

6. The system according to claim 1, wherein, To determine the orientation of the longitudinal axis, the processing circuit is configured to: The optimal fitting line is determined based on the determined position of the electrode.

7. The system of claim 1, wherein the leads comprise segmented leads, and the one or more electrodes are configured to deliver electrical stimulation therapy.

8. The system of claim 1, wherein the processing circuit is further configured to: Determine the number of electrodes included in the one or more electrodes; Determine the number of determined locations of the one or more electrodes; The number of determined locations of the one or more electrodes is different from the number of electrodes themselves; as well as An error is output in response to the determination that the number of the determined location is different from the number of electrodes included in the one or more electrodes.

9. The system of claim 1, wherein the processing circuit is further configured to: Obtain the template model of the lead wire; and Determine the transformation between the determined positions of the one or more electrodes and the plurality of orientation markers and the corresponding positions of the electrodes and orientation markers in the template model, wherein, To determine the rotational orientation of the lead, the processing circuit is configured to: The rotational orientation of the lead is determined based on the transformation.

10. A computer-readable storage medium storing instructions, which, when executed, cause one or more processors to: Obtain an image of a lead implanted in a patient, the lead including one or more electrodes positioned along the longitudinal axis of the lead and a plurality of orientation markers; The corresponding positions of the one or more electrodes and the corresponding positions of the plurality of orientation markers are determined in the image; The orientation of the longitudinal axis is determined based on the respective positions of the one or more electrodes; The corresponding positions of the orientation markers are projected onto a plane orthogonal to the longitudinal axis; as well as The rotational orientation of the lead is determined based on the projection position of the first orientation marker among the plurality of orientation markers in the plane and the projection position of the second orientation marker among the plurality of orientation markers in the plane.

11. The computer-readable storage medium of claim 10, further storing instructions that cause the one or more processors to perform the following operations: Identify the first orientation marker and the second orientation marker in the image, wherein, The instructions that cause the one or more processors to determine the rotational orientation of the lead include instructions that cause the one or more processors to perform the following operations: Determine the vector connecting the first orientation marker and the second orientation marker; Obtain the predetermined offset angle between the vector and one or more of the electrodes; as well as The predetermined offset angle is added to the determined vector to determine the rotational orientation of the electrode.

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