Systems and methods for digital control of intravascular devices - Patents.com
Patent Information
- Application Number
- JP2024533805
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-11-03
- Filing Date
- 2022-12-13
- Publication Date
- 2025-02-25
AI Technical Summary
Endovascular procedures, such as aneurysm embolization and blood clot treatment, are complex and prone to errors due to manual manipulation of devices, which can lead to inconsistent results and potential harm, especially in varied patient anatomies.
A system utilizing a combination of hardware and software to digitally control intravascular devices, allowing precise movement and action through input mechanisms and processors, enabling control of endovascular devices outside the body.
Enables precise and consistent control of intravascular devices, reducing human error and improving procedural outcomes by allowing for controlled movements and actions within the patient's anatomy.
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Abstract
Description
[Technical field]
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 265,331, filed December 13, 2021, U.S. Provisional Patent Application No. 63 / 381,286, filed October 27, 2022, and U.S. Provisional Patent Application No. 63 / 422,074, filed November 3, 2022, each of which is incorporated by reference in its entirety into this specification.
[0002] Technical Field and Background
[0002] The present disclosure relates to systems, methods, and computer readable media for digital control of an intravascular device. For example, the disclosed embodiments can be configured to digitally control an intravascular device to perform at least one desired action within a patient's anatomy. [Background technology]
[0003]
[0003] Intravascular procedures, such as aneurysm embolization or treatment of thrombus with expandable mesh devices, are important tools in the treatment of cardiovascular and neurovascular diseases today. Intravascular procedures are highly complex operations that are often performed in narrow and tortuous vasculature. However, despite this complexity, most intravascular procedures are performed manually, with the physician mechanically manipulating the intravascular device with precise maneuvers to achieve the desired action with the portion of the intravascular device placed at the treatment site. Adding to this complexity, the same maneuvers by the physician may produce different results when performed with different intravascular devices, when used on patients with different characteristics, or when treating different sizes and types of anatomical structures. Errors in the force applied by the physician, whether due to slippage of the hand, judgment errors, or lack of experience with a particular intravascular device, can have serious consequences. Thus, there is a need to replace the mechanical control of the intravascular device with a digital control mechanism to provide precise control of the movement of the intravascular device within the body. Summary of the Invention [Means for solving the problem]
[0004] overview
[0004] Embodiments consistent with the present disclosure generally provide systems, methods, and computer-readable media for digital control of intravascular devices. The disclosed systems and methods may be implemented using combinations of conventional hardware and software, as well as dedicated hardware and software, such as machines specifically constructed and / or programmed to perform the functions associated with the steps of the disclosed methods. Consistent with other disclosed embodiments, a non-transitory computer-readable storage medium may store program instructions executable by at least one processing device to perform any of the steps and / or methods described herein.
[0005]
[0005] Consistent with the disclosed embodiments, a system, method, and computer readable medium for digital control of an intravascular device are disclosed. The embodiments may include at least one processor. The at least one processor may be configured to obtain an input indicative of a first desired action of the intravascular device within the patient's body structure. The at least one processor may also be configured to determine at least one characteristic of a first force based on the input. The at least one processor may also be configured to cause a control device of the intravascular device to exert a first force on a first portion of the intravascular device, the first portion of the intravascular device being disposed outside the patient's body, based on the determined at least one characteristic. In the disclosed embodiments, the exertion of the first force may cause a second portion of the intravascular device to perform the first desired action within the body structure.
[0006]
[0006] Consistent with the disclosed embodiments, a control device for controlling movement of an intravascular device is disclosed. The control device may be configured to be disposed outside a patient's body. The control device may include an input mechanism configured to receive an input from a user, a device movement mechanism configured to control at least one moving part of the intravascular device, the moving part of the intravascular device configured to be disposed inside the patient's body, and at least one processor. The at least one processor may be configured to actuate the device movement mechanism in response to a first input to move the at least one moving part of the intravascular device to move the intravascular device to a first configuration.
[0007]
[0007] Consistent with the disclosed embodiments, a control device for controlling an intravascular device is disclosed. The control device is configured to be placed outside a patient's body. The control device may include an input mechanism configured to receive an input from a user, a first mechanism for controlling a shaft of the intravascular device, and a second mechanism for controlling a core wire of the intravascular device. The control device may be configured to actuate the first mechanism and the second mechanism in response to the first input from the user to move the shaft of the intravascular device a first distance in a first direction and move the core wire of the intravascular device a second distance in a second direction opposite the first direction.
[0008]
[0008] Consistent with the disclosed embodiments, a control device for controlling an intravascular device is disclosed. The control device may be configured to be disposed outside a patient's body. The control device may include an input mechanism configured to receive input from a user and a first mechanism for controlling a core wire of the intravascular device, the core wire extending through a shaft of the intravascular device. The control device may be configured to actuate the first mechanism in response to the input from the user to move the core wire of the intravascular device within the shaft of the intravascular device.
[0009]
[0009] Consistent with the disclosed embodiments, systems, methods, and computer readable media for endovascular treatment are disclosed. The embodiments may include an intravascular device configured for controllable movement at a treatment site within a patient's body, the intravascular device including at least one moving part. The embodiments may also include a control device for controlling the intravascular device. The control device may include an input mechanism configured to receive input from a user, a device movement mechanism configured to control the at least one moving part of the intravascular device, and at least one processor. The at least one processor may be configured to actuate the device movement mechanism in response to a first input to move the at least one moving part of the intravascular device to move the intravascular device to a first configuration at the treatment site.
[0010]
[0010] Consistent with the disclosed embodiments, systems, methods, and computer readable media for endovascular treatment are disclosed. The embodiments may include a control device for controlling an action of an intravascular device at a treatment site within a patient's body. The control device may include a control device body configured to be placed outside the patient's body, a device movement mechanism configured to control at least one adjustable portion of the intravascular device, the at least one adjustable portion configured to be placed at a treatment site within the patient's body, and at least one magnet operatively connected to the device movement mechanism. In response to a first actuation of the at least one magnet, the device movement mechanism may be configured to cause an action by the at least one adjustable portion of the intravascular device to transition the intravascular device to a first configuration at the treatment site.
[0011]
[0011] The foregoing summary provides specific examples of the disclosed embodiments to provide a general understanding of the present disclosure, and is not intended to outline all aspects of the disclosed embodiments. Additional features and advantages of the disclosed embodiments will be set forth in part in the description that follows, and in part will be obvious from the description, or may be learned by practice of the disclosed embodiments. The features and advantages of the disclosed embodiments will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims.
[0012]
[0012] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of embodiments of the disclosure as claimed.
[0013]
[0013] Unless otherwise defined, technical and / or scientific terms used herein have the same or similar meaning as commonly understood by those skilled in the art to which this disclosure pertains. Examples of methods and / or materials are described below, but methods and / or materials similar or equivalent to those described may be used in the practice and / or testing of embodiments of the present disclosure. In case of conflict, the patent specification, including definitions, shall control. The materials, methods, and examples are illustrative only and are not necessarily intended to be limiting.
[0014]
[0014] The accompanying drawings constitute a part of this specification. The drawings illustrate several embodiments of the present disclosure and, together with the description, serve to explain the principles of the disclosed embodiments as set forth in the appended claims.
[0015]
[0015] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate the disclosed embodiments and, together with the description, serve to explain the disclosed embodiments. The details shown are exemplary and are for illustrative purposes of the embodiments of the present disclosure. The description taken together with the drawings makes it clear to a person skilled in the art how the embodiments of the present disclosure can be implemented. [Brief description of the drawings]
[0016] [Figure 1] 1 illustrates an example of an endovascular treatment system consistent with the disclosed embodiments. [Diagram 2]
[0017] 1 shows a schematic diagram of a control device of an endovascular treatment system consistent with disclosed embodiments. [Figure 3A]
[0018] 1 shows an external view of a first example control device of an endovascular treatment system consistent with disclosed embodiments. [Figure 3B]
[0019] 1 shows an external view of a second example control device of an endovascular treatment system consistent with disclosed embodiments. [Figure 4A]
[0020] 1 illustrates an intravascular device having an expandable mesh in a contracted state, consistent with disclosed embodiments. [Figure 4B]
[0021] 4B illustrates a close-up view of the expandable mesh of FIG. 4A positioned at a treatment site within a patient's body, consistent with disclosed embodiments. [Figure 4C]
[0022] 4B illustrates the intravascular device of FIG. 4A with an expandable mesh in an expanded state, consistent with disclosed embodiments. [Figure 4D]
[0023] 4D shows an enlarged view of the expandable mesh of FIG. 4C positioned at a treatment site within a patient's body, consistent with disclosed embodiments. [Figure 5A]
[0024] 1 illustrates an intravascular device having a guidewire in a straightened state, consistent with disclosed embodiments. [Figure 5B]
[0025] 5B illustrates the intravascular device of FIG. 5A with a guidewire in a bent state, consistent with a disclosed embodiment. [Figure 6]
[0026] 1 shows an intravascular device having a deflectable catheter, consistent with disclosed embodiments. [Figure 7]
[0027] 1 is a flow chart illustrating an example of digitally controlling an intravascular device, consistent with certain disclosed embodiments. [Figure 8]
[0028] 13 shows a graph illustrating the change in size of an expandable mesh of an endovascular device over time during partially automated treatment of a hollow body organ with the endovascular device, consistent with disclosed embodiments. [Figure 9A]
[0029] 2 illustrates an example of a graphical user interface (GUI) of the endovascular treatment system of FIG. 1 , consistent with a disclosed embodiment. [Figure 9B] 2 illustrates an example of a graphical user interface (GUI) for the endovascular treatment system of FIG. 1, consistent with a disclosed embodiment. [Figure 9C] 2 illustrates an example of a graphical user interface (GUI) for the endovascular treatment system of FIG. 1, consistent with a disclosed embodiment. [Figure 10]
[0030] 3 illustrates an example of a device movement mechanism for the control device of FIG. 2, consistent with disclosed embodiments. [Figure 11]
[0031] 3 illustrates an example of a device movement mechanism for the control device of FIG. 2, consistent with disclosed embodiments. [Figure 12]
[0032] 3 illustrates an example of a device movement mechanism for the control device of FIG. 2, consistent with disclosed embodiments. [Figure 13]
[0033] 3 illustrates an example of a device movement mechanism for the control device of FIG. 2, consistent with disclosed embodiments. [Figure 14]
[0034] 1 illustrates an example of an endovascular treatment system consistent with disclosed embodiments. [Figure 15A]
[0035] 15 illustrates an example of a magnet-controlled device movement mechanism for the endovascular treatment system of FIG. 14, consistent with disclosed embodiments. [Figure 15B]
[0035] An example of a magnet-controlled device movement mechanism of the endovascular treatment system of Figure 14 is shown, consistent with the disclosed embodiments. [Figure 15C]
[0035] An example of a magnet-controlled device movement mechanism of the endovascular treatment system of Figure 14 is shown, consistent with the disclosed embodiments. [Figure 16]
[0036] 15 illustrates an example of a device movement mechanism of the endovascular treatment system of FIG. 14, consistent with disclosed embodiments. [Figure 17]
[0037] 15 illustrates an example of a device movement mechanism of the endovascular treatment system of FIG. 14 consistent with disclosed embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0017] Detailed Description
[0038] Examples of embodiments are described with reference to the accompanying drawings. In the figures, which are not necessarily drawn to scale, the leftmost digit of a reference number identifies the figure in which the reference number first appears. For convenience, the same reference numbers are used throughout the drawings to refer to the same or similar parts. Although examples and features of the disclosed principles are described herein, modifications, adaptations, and other implementations are possible without departing from the spirit and scope of the disclosed embodiments. Also, the words "comprising," "having," "containing," and "including," as well as other similar forms, are equivalent in meaning and are intended to be open-ended in that the term "comprising," "having," "containing," and "including" followed by any one of these words is not intended to imply an exhaustive list of such one or more items or to be limited to only the listed one or more items. It should also be noted that, as used in this disclosure and the appended claims, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise.
[0018]
[0039] Unless expressly stated otherwise, and as will become apparent from the description below, throughout this specification, descriptions using terms such as "processing," "computing," "operating," "determining," "generating," "setting," "configuring," "selecting," "defining," "applying," "obtaining," "monitoring," "providing," "identifying," "segmenting," "classifying," "analyzing," "associating," "extracting," "storing," "receiving," "transmitting," and the like, include computer actions and / or processes that manipulate and / or transform data into other data, where data is represented as a physical quantity, e.g., electronic quantities, and / or where data represents a physical object. The terms "computer," "processor," "controller," "processing unit," "computing unit," and "processing module" should be interpreted broadly to encompass any type of electronic device, component, or unit having data processing capabilities, including, by way of non-limiting example, a personal computer, a wearable computer, smart glasses, a tablet, a smartphone, a server, a computing system, a cloud computing platform, a communications device, a processor (e.g., a digital signal processor (DSP), an image signal processor (ISR), a microcontroller, a field programmable gate array (FPGA), an application specific integrated circuit (ASIC), a central processing unit (CPA), a graphics processing unit (GPU), a visual processing unit (VPU), etc.), optionally with embedded memory, a single core processor, a multi-core processor, a core within a processor, any other electronic computing device, or a combination of any of the above.
[0019]
[0040] Operations according to the teachings herein may be performed by a computer specially constructed or programmed to perform the functions described.
[0020]
[0041] As used herein, the phrases "for example," "such as," "for instance," and variations thereof describe non-limiting embodiments of the subject matter of the present disclosure. Reference herein to a feature in an "embodiment," "in one instance," "in some instances," "in other instances," or variations thereof means that the particular feature, structure, or characteristic described may be included in at least one embodiment of the subject matter of the present disclosure. Thus, occurrences of such terms do not necessarily refer to the same embodiment. As used herein, the term "and / or" includes any combination of one or more of the associated listed items. As used herein, the phrase "or at least one of" may include each of the listed items individually or any combination of the listed items. For example, the phrase "at least one of A, B, or C" may include any of A, B, or C alone, or any combination of A, B, and C (e.g., A+B, A+C, B+C, or A+B+C).
[0021]
[0042] Features of the subject matter of this disclosure are described in the context of specific embodiments for brevity. It should be understood, however, that features described with respect to one embodiment may also be applied to other embodiments. Similarly, features described in the context of a particular combination may be considered separate embodiments, either alone or in a context other than the particular combination.
[0022]
[0043] In embodiments of the presently disclosed subject matter, one or more of the steps shown in the diagram may be performed in a different order and / or one or more steps may be performed simultaneously, or vice versa. The diagram illustrates a general overview of a system architecture in accordance with an embodiment of the presently disclosed subject matter. Each module in the diagram may be comprised of any combination of software, hardware and / or firmware that performs the functions defined and described herein. The modules in the diagram may be centralized in one location or distributed across more than one location.
[0023]
[0044] Examples of the subject matter of the present disclosure are not limited in their application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The subject matter can be practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting.
[0024]
[0045] In this document, numbered drawing elements that are not depicted within the drawing but appear in a previous drawing may have the same purpose and description as in the previous drawing.
[0025]
[0046] The drawings in this document may not be to scale: different figures may use different scales, and even within the same drawing, different scales may be used, for example, for different views of the same object, or for two adjacent objects.
[0026]
[0047] Consistent with disclosed embodiments, "at least one processor" may constitute any physical device or group of devices having electrical circuitry that performs logical operations on one or more inputs. For example, the at least one processor may include one or more integrated circuits (ICs) including an application specific integrated circuit (ASIC), a microchip, a microcontroller, a microprocessor, all or part of a central processing unit (CPU), a graphics processing unit (GPU), a digital signal processor (DSP), a field programmable gate array (FPGA), a server, a virtual server, or other circuitry suitable for executing instructions or performing logical operations. The instructions executed by the at least one processor may be preloaded, for example, into a memory integrated or embedded in the controller, or may be stored in a separate memory. The memory may include a random access memory (RAM), a read-only memory (ROM), a hard disk, an optical disk, a magnetic medium, a flash memory, other persistent, fixed, or volatile memory, or any other mechanism capable of storing instructions. In some embodiments, the at least one processor may include more than one processor. Each processor may have a similar configuration, or the processors may be of different configurations that are electrically connected or disconnected from one another. For example, the processors may be separate circuits or integrated into a single circuit. When more than one processor is used, the processors may be configured to operate independently or in concert. The processors may be coupled electrically, magnetically, optically, acoustically, mechanically, or by other means that allow them to interact.
[0027]
[0048] The disclosed embodiments may include and / or access data structures. Data structures consistent with this disclosure may include any collection of data values and relationships between them. Data may be stored linearly, horizontally, hierarchically, relationally, non-relationally, one-dimensionally, multi-dimensionally, operationally, in an ordered manner, in an unordered manner, in an object-oriented manner, in a centralized manner, in a decentralized manner, in a distributed manner, in a custom manner, or in any manner that allows data access. As non-limiting examples, data structures may include arrays, associative arrays, linked, linked lists, binary trees, balanced trees, heaps, stacks, queues, sets, hash tables, records, tagged unions, ER models, and graphs. For example, the data structure may include an XML database, an RDBMS database, an SQL database, or a NoSQL alternative for data storage / retrieval, such as MongoDB, Redis, Couchbase, Datastax Enterprise Graph, Elastic Search, Splunk, Solr, Cassandra, Amazon DynamoDB, Scylla, HBase, and Neo4J. The data structure may be a component of the disclosed system or a remote computing component (e.g., a cloud-based data structure). The data in the data structure may be stored in contiguous or non-contiguous memory. Furthermore, data structure, as used herein, does not require that the information be in the same location. The data structure may be distributed across multiple servers, which may be owned or operated by the same or different entities. Thus, the term "data structure" when used in the singular form herein encompasses multiple data structures.
[0028]
[0049] Embodiments of the present disclosure relate to systems for performing various operations or functions described herein, including digital control of at least one intravascular device. The disclosed systems may be specially constructed for a particular purpose and / or may include at least one general-purpose processor that is selectively activated or configured by a software program executed by the at least one processor. In some embodiments, the operations and functions performed by the disclosed systems or by at least one processor of the disclosed systems may additionally or alternatively be implemented as steps of a method or process, or as operations performed when instructions contained in a non-transitory computer-readable medium are executed (e.g., by at least one processor).
[0029]
[0050] Embodiments of the present disclosure relate to methods for performing various operations or functions described herein, including digital control of at least one intravascular device. Aspects of the methods disclosed herein may be performed electronically, such as by at least one processor, and may occur over a wired, wireless, or both wired and wireless network. Aspects of the methods disclosed herein may additionally or alternatively be performed using non-electronic means. In the broadest sense, the disclosed methods are not limited to specific physical and / or electronic means (except as specified in this disclosure or the claims presented herein), but rather may be accomplished using many different means. In some embodiments, steps of the methods disclosed herein may be performed by features of the disclosed systems (e.g., by at least one processor of the systems disclosed herein) or may be performed as operations performed when instructions contained in a non-transitory computer-readable medium are executed (e.g., by at least one processor).
[0030]
[0051] An embodiment of the present disclosure relates to a non-transitory computer-readable medium including instructions for performing various operations or functions described herein, including digital control of at least one intravascular device. Consistent with the disclosed embodiments, the non-transitory computer-readable medium may store program instructions that are executable by at least one processor and that, when executed, cause the at least one processor to perform the steps and / or methods described herein. As used herein, a non-transitory computer-readable medium may refer to any type of physical memory that can store information or data that can be read by at least one processor. Examples may include random access memory (RAM), read-only memory (ROM), volatile memory, non-volatile memory, hard drives, CD ROM, DVD, flash drives, disks, and any other known physical storage medium. Singular terms such as "memory" and "computer-readable medium" may refer to multiple structures, such as multiple memories or computer-readable media, in some embodiments. The computer-readable medium may store instructions for execution by at least one processor, including instructions for causing the processor to perform steps or stages consistent with the disclosed embodiments. Additionally, one or more computer-readable mediums may be used in carrying out the computer-implemented methods. The term "computer-readable medium" should be understood to include tangible articles, and to exclude carrier waves and transient signals.
[0031]
[0052] Embodiments of the present disclosure relate to intravascular devices, as well as systems, methods, and non-transitory computer-readable media for controlling intravascular devices. As used herein, an intravascular device may refer to any device or instrument configured to be placed within a blood vessel or another body structure or organ in a human body for medical purposes, e.g., to diagnose and / or treat a patient, or to operate within a blood vessel or another body structure or organ in a human body for medical purposes, e.g., to diagnose and / or treat a patient. In disclosed embodiments, the body structure may include hollow anatomical features within a patient's body. Non-limiting examples of body structures include blood vessels, capillaries, aneurysms, esophagus, stomach, intestines, gallbladder, urethra, fallopian tubes, vaginal canal, bladder, or any other hollow body structure or organ. In some embodiments, an intravascular device may include any device or instrument configured to be used during or otherwise facilitate endovascular procedures and procedures, as described in more detail herein. An intravascular device may be configured to deliver a device, drug, or substance from a first location (e.g., a location outside the body) to a treatment site within a blood vessel or other body structure and / or remove a device, object, or substance (e.g., a thrombus or other obstruction) from a blood vessel or other body structure. Additionally or alternatively, in some embodiments, an intravascular device may be configured to cause a temporary or permanent change or deformation at a treatment site within a blood vessel (e.g., dilating a narrowed blood vessel or ablating vascular tissue). Some non-limiting examples of intravascular devices consistent with the present disclosure may include catheters (e.g., aspiration catheters or guide catheters), microcatheters, balloon catheters, devices having an expandable mesh (e.g., devices having an adjustable mesh and / or a stent retriever), medical sheaths, guidewires (e.g., controllable guidewires), coils, endovascular revascularization devices, embolization devices, ablation devices, stents, stent retrievers, or any other device configured to be placed within a blood vessel or other body structure.
[0032]
[0053] FIELD OF THE DISCLOSURE Embodiments of the present disclosure generally relate to medical devices, methods, and systems for treating occlusions in the body. More specifically, embodiments of the present disclosure relate to devices and methods for removing blood clots, including but not limited to emboli and thrombi, from hollow body structures or organs, such as blood vessels. Additionally or alternatively, embodiments of the present disclosure may also be used to dilate occluded hollow body structures or organs (e.g., blood vessels), as well as in other medical procedures where support of hollow body structures or organs (e.g., blood vessels) is desired. Examples of medical procedures include, but are not limited to, thrombectomy, vascular remodeling, vascular support, vasodilation, angioplasty, and embolization of aneurysms. Additionally, embodiments of the present disclosure may also be used to address other diseases of the body's vascular system.
[0033]
[0054] 4A-4D show a first non-limiting example of an intravascular device 1200a configured to be controlled by a control device 1400 (described in more detail below). The intravascular device 1200a may include a hollow elongated shaft 4220 fixedly attached to the control device 1400 and at least one expandable mesh segment 4210 connected to or otherwise distal to a distal end of the shaft 4220. Optionally, a flexible atraumatic tip 4240 may be fixedly attached to the distal end of the intravascular device 1200a. The mesh segment 4210 may be formed by multiple wires woven or wound to form an expandable mesh. Intravascular device 1200a may also include a core wire 4230 (e.g., a control wire) that may be manipulated to effect radial expansion and contraction of mesh segment 4210 between a contracted state (FIGS. 4A-4B) and an expanded state (FIGS. 4C-4D). In the illustrated example, a first end of core wire 4230 may be securely attached to a distal end 4212 of the mesh segment (or to mesh segment 4210 or any other suitable portion of intravascular device 1200a). Core wire 4230 may extend integrally through elongate shaft 4220 such that a second end of core wire may be connected to control device 1400. For example, the second end of core wire 4230 may be operatively connected to device movement mechanism 2412 of control device 1400. The device movement mechanism 2412 may be configured to axially move the core wire 4230 in a proximal (right in FIGS. 4A-4D ) or distal (left in FIGS. 4A-4D ) direction, thus moving the mesh distal end 4212 relative to the mesh proximal end 4214 and expanding or contracting the mesh segment 4210. Consistent with disclosed embodiments, the intravascular device 1200a may be configured as a clot retrieval device, a device for mechanical expansion of a body structure (e.g., a blood vessel), or a vascular remodeling device. Additionally or alternatively, the intravascular device 1200a may be configured to support a blood vessel during treatment of an aneurysm (e.g., while coils or other materials are delivered into the aneurysm to fill the aneurysm).
[0034]
[0055] The mesh segment 4210 may have a reduced outer diameter (e.g., 0.5 mm to 2.0 mm) in a contracted state such that the mesh segment 4210 may be sized to be retained within a delivery device. To expand the mesh, the distal and proximal ends 4212 and 4214 of the mesh may be pulled closer together (e.g., by having the core wire 4230 pull the distal end 4212 in a proximal direction), causing the central portion of the mesh segment 4210 to expand outward toward the vessel wall 4010. Thus, the outer diameter of the mesh segment 4210 is larger when in the expanded state. In some embodiments, different degrees of expansion of the mesh segment 4210 may be achieved by adjusting the distance between the distal and proximal ends 4212 and 4214. For example, the mesh segment 4210 may be partially expanded by pulling the distal and proximal ends 4212 and 4214 of the mesh apart a first distance. In comparison, the mesh segment 4210 can be fully expanded by continuing to reduce the distance between the distal end 4212 and the proximal end 4214 until a desired degree or size of expansion is achieved (e.g., until the mesh segment 4210 contacts the vascular wall 4010).
[0035]
[0056] In some embodiments, the wires forming the mesh segment 4210 may be braided in a particular pattern to perform at least one action within a blood vessel. For example, the wires of the mesh segment 4210 may be braided to form a clot capture mechanism, with the openings 4216 (see FIG. 4D) between the individual wires being sized to capture and hold occlusive material (e.g., a thrombus) when the mesh segment is expanded. Additionally or alternatively, the wires of the mesh segment 4210 may be braided to form a clot anchoring segment configured to expand radially outward toward the vessel wall 4010 to capture occlusion material 4012 (see FIG. 4D) such that when the expanded mesh segment 4210 is pulled proximally, it can push the captured occlusion material 4012 upstream so that the occlusion material may be removed from the body.
[0036]
[0057] 4A-4D includes a single mesh segment 4210, alternative embodiments of intravascular device 1200a may include two mesh segments, three mesh segments, four mesh segments, or any other suitable number of mesh segments. In embodiments including multiple mesh segments, each mesh segment may be individually expandable (e.g., each segment may include its own core wire) or, alternatively, all of the mesh segments may be configured to be expanded simultaneously (e.g., by a single core wire connected to the distal-most mesh segment).
[0037]
[0058] 5A and 5B show another non-limiting example of an intravascular device 1200b that may be controlled by the control device 1400. The intravascular device 1200b may include a deflectable guidewire that includes a hollow elongated shaft 5220 (e.g., hypotube) connected to the control device 1400 that may be configured to control bending and straightening of at least one bendable section 5202 of the guidewire. In some embodiments, the elongated shaft 5220 (e.g., hypotube) may be sized and configured to traverse the human vasculature. In some embodiments, the intravascular device 1200b may include an elongated coil secured to a distal end of the elongated shaft 5220 (e.g., hypotube) as shown and described in U.S. Pat. No. 11,389,172, which is incorporated herein by reference. Intravascular device 1200b may further include a core wire (e.g., a control wire, not shown) connected to control device 1400 and extending through elongate shaft 5220 (e.g., a hypotube) to a connection point with elongate shaft 5220 (e.g., at or near the distal end of bendable section 5202 of intravascular device 1200b, such as distal end 5420 of intravascular device 1200b). In some embodiments, the core wire of intravascular device 1200b may be operatively connected to a device movement mechanism 2412 of control device 1400, which may be configured to axially move the core wire in a proximal direction (right in FIGS. 5A-5B) or a distal direction (left in FIGS. 5A-5B). For example, to cause bending of the guidewire, the device movement mechanism 2412 may pull the corewire proximally, which may pull the connection point (e.g., distal end 5240) towards the control device 1400 and bend the bendable section 5202. To straighten the guidewire, for example, the device movement mechanism 2412 may push the corewire distally, which may push the connection point (e.g., distal end 5240) away from the control device 1400 and straighten the bendable section 5202 (i.e., reduce the degree of bending of the bendable section 5202).
[0038]
[0059] 5A-5B includes a single bendable section 5202. Alternative embodiments of intravascular device 1200b may include two bendable sections, three bendable sections, four bendable sections, or any other suitable number of bendable sections. In embodiments including multiple bendable sections, each bendable section may be bent individually (e.g., each segment may include its own control wire).
[0039]
[0060] FIG. 6 illustrates another non-limiting example of intravascular device 1200c including a deflectable catheter that can be controllably bent and straightened by control device 1400. The catheter of FIG. 6 can include an aspiration catheter, a guide catheter, or any other suitable type of catheter or medical sheath device. In some embodiments, the catheter of intravascular device 1200c can be configured to bend in one direction, bend in two directions, or have other configurations for bending. Intravascular device 1200c can include a flexible elongate sheath 6220 and, optionally, a flexible coil segment 6222 disposed near a distal end of intravascular device 1200c. Intravascular device 1200c can also include a core wire (e.g., a control wire, not shown) that extends through elongate sheath 6220 and, in some embodiments, through coil segment 6222. A first end of the core wire may be securely attached to the control device 1400, and a second end of the core wire may be securely attached to a deflectable segment 6202 of the catheter, such as a connection point at or near the distal tip 6240 of the intravascular device.
[0040]
[0061] In some embodiments, the device movement mechanism 2412 can be securely attached to a proximal end of the core wire and configured to move the core wire axially, causing bending and straightening of the deflectable segment 6202 of the intravascular device 1200c. As an example, in one implementation, the device movement mechanism 2412 can push the core wire distally, curving the deflectable segment 6202 in a first direction (e.g., clockwise in FIG. 6). The device movement mechanism 2412 can also pull the core wire proximally, curving the deflectable segment 6202 in the opposite direction (e.g., counterclockwise in FIG. 6).
[0041]
[0062] In some embodiments, the intravascular device may be a wire and / or coil that may be controllably heated and / or cut. The wire and / or coil may be used in an embolization procedure to treat an aneurysm, or any other suitable intravascular procedure that may use a wire and / or coil. The wire may be flexible so as to be configured to be wound inside the aneurysm and prevent blood from flowing into or out of the aneurysm.
[0042]
[0063] In some embodiments, the device movement mechanism 2412 can be securely attached to the proximal end of the wire and configured to move the wire axially. As an example, in one implementation, the device movement mechanism 2412 can push the wire distally, winding the wire inside the aneurysm. The device movement mechanism 2412 can also pull the wire proximally.
[0043]
[0064] Disclosed embodiments include systems, methods, and non-transitory computer readable media for digital control of an intravascular device or devices. In some embodiments, a non-transitory computer readable medium is provided that includes instructions that, when executed by at least one processor, cause the at least one processor to perform operations for digital control of an intravascular device. As used herein, a system for digital control of an intravascular device may refer to a system that uses at least one digital processor to control the actions of an intravascular device both inside and outside a patient's body. Thus, in some embodiments, an intravascular device may be controlled and operated by a digital processor to perform an intravascular procedure without a physician or other user manually operating the intravascular device. A user may be any medical professional, such as, but not limited to, an interventional radiologist, an interventional cardiologist, an interventional neurologist, a surgeon, a nurse, and a technician. Similarly, a method of digital control of an intravascular device may refer to a method of operating or controlling the actions of an intravascular device by a digital computing device. In some embodiments, the disclosed systems can include at least one processor electronically connected to a component that causes movement of the intravascular device or other action by the intravascular device (e.g., a motor for causing movement of the intravascular device or a mechanism for advancing or retracting a core wire of the intravascular device). The at least one processor can be configured to output a digital signal to the component, and the component can control the movement or other action of the intravascular device based on the digital signal.
[0044]
[0065] FIG. 1 illustrates a non-limiting example of a system 1000 for digital control of an intravascular device 1200. Intravascular device 1200 may include any suitable intravascular device, including devices 1200a-1200c illustrated in FIGS. 4A-6. System 1000 may include a control device 1400 configured to control movement and other actions of intravascular device 1200. For example, and as described elsewhere in this disclosure, control device 1400 may include an input mechanism for receiving input from a user and may be configured to control intravascular device 1200 based on the received user input. In some embodiments, control device 1200 may be configured to control more than one intravascular device 1200 (e.g., simultaneously or subsequent to one another).
[0045]
[0066] In some embodiments, system 1000 may include at least one sensor 1600 configured to measure a characteristic of the patient's body or intravascular device 1200. For example, sensor 1600 may include a force sensor configured to measure a force exerted when intravascular device 1200 is removed from a blood vessel (e.g., when intravascular device 1200 is removed from the patient's body by control device 1400 or a user). Sensor 1600 may provide a sensor output to control device 1400, which may use the sensor output to control intravascular device 1200. While FIG. 1 shows a wired connection between control device 1400 and sensor 1600, in alternative embodiments, control device 1400 and sensor 1600 may be connected by a wireless connection (e.g., by Bluetooth, Wi-Fi, or RF signals). In some embodiments, sensor 1600 may provide a sensor output to peripheral device 1800. Peripheral device 1800 and sensor 1600 may be connected by a wired connection. In other embodiments, the peripheral device 1800 and the sensor 1600 may be connected by a wireless connection (e.g., by Bluetooth, Wi-Fi, or RF signals). According to other embodiments, the sensor 1600 may provide a sensor output to both the control device 1400 and the peripheral device 1800. According to another embodiment, the system 1000 may not include the sensor 1600.
[0046]
[0067] In some embodiments, system 1000 may include a peripheral device 1800 connected to control device 1400 by a wired and / or wireless connection. Peripheral device 1800 may include at least one processor and a user interface, such as a visual display or a graphical user interface (GUI). For example, peripheral device 1800 may include a desktop computer, a laptop computer, a tablet, a smartphone, a surgical control device or panel, a display screen, a television, a handheld device, a touch screen device, or another instrument. In some embodiments, alerts and other feedback related to the operation of intravascular device 1200 may be provided via a user interface of peripheral device 1800. Additionally or alternatively, a physician or other user may provide input via a user interface of peripheral device 1800, which may relay the input to control device 1400 to control actions of intravascular device 1200 based on the user's input.
[0047]
[0068] 2 shows a schematic diagram of the control device 1400. In some embodiments, the control device 1400 may be configured as a portable handheld device that a physician or other user can easily hold and operate during a procedure with the intravascular device 1200. The control device 1400 may include a device cover 2410, a device movement mechanism 2412, a controller 2414, and a power source 2416 (e.g., a battery or an external power source). In some embodiments, the controller 2414 may include a printed circuit board (PCB) having a motor controller for the device movement mechanism 2412, a data structure (e.g., a memory), and a communication mechanism (e.g., an antenna for wireless communication via radio frequency signals or any other suitable communication medium). The control device 1400 may also include a sensor input 2418 for receiving an output from the sensor 1600. Thus, the controller 2414 may be connected to a force sensor interface circuit for receiving an output from the sensor 1600. The control device 1400 may also include at least one intravascular device actuator 2420 that may provide a mechanical connection between the intravascular device 1200 and a device movement mechanism 2412. The actuator 2420 may be configured as a control feature of the intravascular device 1200 (e.g., a control wire 4230 of the intravascular device 1200a in FIGS. 4A-4D, a control wire of a guidewire, or a control wire of a guide catheter) such that movement of the actuator 2420 may cause the intravascular device to perform a desired action. The device movement mechanism 2412 may be connected to the actuator 2420 and configured to move the actuator 2420 axially (e.g., left or right in FIG. 2), rotationally, or in any other desired movement, thereby controlling the movement and other actions of the intravascular device 1200. In some embodiments, the control device 1400 may include only the device movement mechanism 2412 and not a processor.
[0048]
[0069] In disclosed embodiments, device movement mechanism 2412 may include at least one of a motor, an encoder, or gears that may be configured to move at least one movable part of intravascular device 1200. For example, controller 2414 may control device movement mechanism 2412 to perform a desired movement of intravascular device 1200 using at least one of a motor, an encoder, or gears. In some embodiments, at least one of a motor, an encoder, or gears may be configured to move at least one movable part of intravascular device 1400 based on at least one of a user input received by an input mechanism of control device 1400 (e.g., control buttons shown in FIGS. 3A and 3B), a signal from at least one sensor (e.g., sensor 1600), a signal from a processor of a user interface device (e.g., peripheral device 1800), or computer executable instructions for treatment by intravascular device 1200 stored in a memory of controller 2414.
[0049]
[0070] In some embodiments, control device 1400 may be configured to be operatively connected to at least one peripheral device, such as device 1800. Peripheral device 1800 may include at least one of a visual display screen, a control screen, or a computing device. Control device 1400 may be connected to peripheral device 1800 by a wired and / or wireless connection, such as via Wi-Fi, Bluetooth, or any other suitable communication medium.
[0050]
[0071] The disclosed embodiments may include at least one processor, as defined elsewhere in this disclosure. For example, the disclosed system for digital control of an intravascular device may include at least one processor. In FIG. 2, controller 2414 is an example of at least one processor.
[0051]
[0072] The disclosed embodiments may include obtaining an input indicative of a first desired action of the intravascular device within the patient's body structure. For example, at least one processor of the disclosed system may be configured to obtain an input indicative of a first desired action of the intravascular device within the patient's body structure. As used herein, a first desired action of the intravascular device may include movement of the intravascular device (e.g., forward or distal movement or rearward or proximal movement of the intravascular device), positioning of the intravascular device at a specified location (e.g., a treatment site within the patient's body or a specified anatomical location such as a bifurcation of a body structure), removal of the intravascular device from the patient's body, activation or deactivation of a component of the intravascular device (e.g., activation of an electrode of the intravascular device), a change or deformation of the intravascular device (e.g., expansion or contraction of a mesh segment of the intravascular device, bending of a distal portion of the intravascular device, or a temperature change), or any other desired outcome or effect achieved by the intravascular device.
[0052]
[0073] In disclosed embodiments, the first desired action may include bending a distal portion of a guidewire (e.g., a distal tip of the guidewire) or a distal portion of a guide catheter within a body structure. Examples include bending at least one distal portion of a guidewire or guide catheter to a desired curvature and bending at least one distal portion of a guidewire or guide catheter from a curved configuration to a straight configuration. By way of illustration, FIGS. 5A-5B show bending a bendable section 5202 of a guidewire of intravascular device 1200b at the distal end of the guidewire (FIG. 5A) or at another distal bendable portion of the device (FIG. 5B) from a straight configuration to a curved configuration. As another example, FIG. 6 shows bending a deflectable segment 6202 of a catheter of intravascular device 1200c.
[0053]
[0074] Additionally or alternatively, the first desired action may include expanding or contracting the distal portion of the intravascular device. As used herein, expanding the distal portion of the intravascular device may refer to an increase in size or at least one dimension of the intravascular device (e.g., an increase in the outer diameter, inner diameter, height, length, or width of the distal portion of the intravascular device). Additionally, contraction may refer to a decrease in size or at least one dimension of the distal portion of the intravascular device, also referred to as collapsing or relaxing. In some embodiments, the distal portion of the intravascular device may include a structure configured to expand and contract while the remainder of the device remains unchanged, such as an expandable mesh or stent or an inflatable balloon. For example, the first desired action may include expanding or contracting the distal portion of the intravascular device to achieve a particular size or degree of expansion or contraction, including a fully contracted state, a fully expanded state, or at least one intermediate state between the expanded state and the contracted state. By way of example, FIGS. 4A-4D show the expansion of an expandable mesh segment 4210 at a distal portion of intravascular device 1200a from a contracted state (FIGS. 4A-4B) to an expanded state (FIGS. 4C-4D).
[0054]
[0075] Additionally or alternatively, the first desired action may include movement of the tip of the intravascular device or the entire intravascular device. For example, movement of the tip may include forward (distal) movement, rearward (proximal) movement, lateral or side-to-side movement, vertical movement, bending, straightening, rotating, or any other desired movement of the tip of the intravascular device. Other examples include controlling the advancement of the intravascular device to a desired location within the patient's body or removing the intravascular device from the patient's body. For purposes of illustration, FIG. 6 shows controlling the movement (specifically, bending) of a deflectable segment 6202 of an intravascular device 1200c including a distal tip 6240.
[0055]
[0076] Additionally, in some embodiments, the first desired action may include heating or disconnecting the intravascular device. For example, the first desired action may include heating the intravascular device while the intravascular catheter remains within the patient's body to provide rapid, controlled rewarming in the event of hypothermia. As another example, the first desired action may include heating the intravascular device to cause detachment of the intravascular coil during coil embolization. Additionally, in yet another example, the first desired action may include mechanical detachment of the intravascular coil during coil embolization.
[0056]
[0077] In some embodiments, the input may be obtained from a user interface and may constitute a user input specifying a first desired action of the intravascular device. For example, the input indicating the desired first action may include an input from a user performing a procedure with the intravascular device. Thus, the desired first action specified by the obtained input may correspond to a next step of a procedure to be performed with the intravascular device. In some embodiments, the input from the user may be obtained from at least one of a manual input mechanism (e.g., a button, keyboard, computer mouse, lever, joystick, foot switch or pedal, or touch screen), a voice input mechanism (e.g., a microphone device configured to recognize verbal commands), a graphical user interface, or any other interface for receiving input from a user specifying a first desired action of the intravascular device.
[0057]
[0078] In the disclosed embodiment, the input from the user indicating the first desired action may be obtained from a control handle operatively connected to the at least one processor. For example, the user may manipulate an interface of the control handle 1400 to indicate the first desired action to the at least one processor (e.g., controller 2414). FIGS. 3A and 3B show two non-limiting examples of the user interface of the control device 1400. In the example shown in FIG. 3A, the control device 1400a may include an arrangement of buttons or other manual input mechanisms for specifying the first desired action of the intravascular device to the at least one processor. The user interface of the control device 1400a may include a button 3430 for expanding the expandable portion of the intravascular device (e.g., mesh segment or inflatable balloon) and a button 3432 for deflating the expandable portion of the intravascular device (e.g., mesh segment or inflatable balloon). Additionally, button 3434 may cause activation or deactivation of pulsatile motion (e.g., of a mesh segment or inflatable balloon) by an expandable portion of the intravascular device, button 3436 may cause control device 1400a to move intravascular device 1200 to a retrieval position (e.g., by deflating an expandable portion of intravascular device 1200, e.g., a mesh segment or an inflatable balloon, and / or removing the intravascular device from the body structure and / or from the patient's body), and button 3438 may cause an automated operation (e.g., without further user input) to control intravascular device 1200 by control device 1400. For example, button 3438 may be pressed by a user to indicate that the device is in place and automation may be started or resumed. By operating a button on the user interface of control device 1400a, a user may specify a first desired action of intravascular device 1200 to at least one processor, and the at least one processor may control the intravascular device to perform the first desired action in the patient's body structure.
[0058]
[0079] 3B illustrates another non-limiting example of an arrangement of buttons or other manual input mechanisms on control device 1400b for designating a first desired action of the intravascular device to at least one processor. The user interface of control device 1400b may include multiple buttons 3444-3450 indicating a desired size, shape, or dimension of the expandable portion of intravascular device 1200 and / or indicating a size, shape, or dimension of a body structure to be treated with intravascular device 1200. For example, buttons 3444, 3446, 3448, and 3450 may send a signal to control device 1400b to expand the expandable portion of intravascular device 1200 (e.g., an expandable mesh or inflatable balloon) to have an outer diameter of 1 mm, 2 mm, 3 mm, and 4 mm, respectively. Although the illustrated example of control device 1400b shows four buttons 3444-3450 for designating a size of the expandable portion of the intravascular device, more or fewer buttons may be implemented in alternative embodiments. Additionally or alternatively, one or more buttons may be provided on control device 1400b to specify particular values for other dimensions or characteristics of intravascular device 1200, such as the degree of curvature or length of the intravascular device to be advanced from the delivery device into the patient's body. Button 3440 may also be provided on control device 1400b to specify automatic activation or deactivation of a particular motion (e.g., a pulsating motion or a massaging motion) by intravascular device 1200, optionally for a predetermined period of time. Button 3436 (as described above) may also be provided on control device 1400b.
[0059]
[0080] Those skilled in the art will appreciate that the buttons of control device 1400 shown in FIGS. 3A and 3B are provided as non-limiting examples, and that any suitable configuration of buttons or other input structures, including buttons or other structures of different shapes, sizes, and / or colors, and any desired number of buttons or other structures may be included in the user interface of control device 1400.
[0060]
[0081] Additionally or alternatively, the input from the user indicating the first desired action may be obtained from a device including at least a second processor. The device including at least a second processor may include a device connected to the control device by a wired, wireless, or magnetic connection (described in more detail below), and optionally includes a user interface for receiving the input from the user indicating the first desired action of the intravascular device. Thus, the user input may be obtained remotely from the device including at least a second processor and transmitted to the control device. In disclosed embodiments, the user interface of the device including at least a second processor may include the functionality of the user interface of the control device as described above. One example of a device including at least a second processor includes the peripheral device 1800 of FIG. 1 as described elsewhere in this disclosure.
[0061]
[0082] In disclosed embodiments, the input indicating the desired first action may additionally or alternatively include at least one first medical image data taken before or during a procedure performed with the intravascular device. For example, the at least one medical image may be taken before the procedure and indicates the condition of the site within the patient's body to be treated during the procedure. Before the invasive procedure may refer to a period of time before the invasive procedure is performed, before the intravascular device is inserted into the patient, and / or before the intravascular device reaches a particular location within the patient's body. The medical image data may be used to plan the procedure with the intravascular device, including the particular action to be performed by the intravascular device at the treatment site within the body. Additionally or alternatively, an imaging device may be provided during the procedure to take at least one medical image of the treatment site and / or the intravascular device. Non-limiting examples of the at least one medical image may include an angiogram, a computed tomography image, a magnetic resonance image, an ultrasound, or an x-ray. Data of the at least one medical image may be used as feedback to modify one or more parameters of the procedure (e.g., feedback regarding the condition of the treatment site, information regarding the placement of the intravascular device at a particular anatomical location, or information regarding the status of the intravascular device during the procedure) or to generate an alarm when an action by the intravascular device exceeds a safety threshold (e.g., when an obstruction that may damage the intravascular device is visualized in the patient's body, when the intravascular device contacts an incorrect part of the patient's body, or when excessive force is exerted by the intravascular device on a body structure, etc.). With reference to FIG. 1, an imaging device may be included in the system 1000 as a peripheral device 1800. Thus, in some embodiments, the peripheral imaging device 1800 may take at least one medical image, process the at least one medical image, and transmit data of the at least one medical image to the control device 1400 and / or at least one processor of the system 1000. Additionally or alternatively, the imaging device may be included in the system 100 as an additional imaging device (not shown in FIG. 1).Thus, in some embodiments, the additional imaging device may capture at least one medical image, process the at least one medical image, and transmit data of the at least one medical image to the peripheral device 1800, the control device 1400, and / or at least one processor of the system 1000. The transmitted data of the at least one medical image may include raw medical image data, processed medical image data, or data generated from analysis of the at least one medical image by the peripheral device 1800 and / or the additional imaging device.
[0062]
[0083] In the disclosed embodiment, the input indicative of the desired first action may additionally or alternatively include second data obtained from at least one sensor output. For example, sensors for monitoring the condition of the patient's body and / or the intravascular device may be provided to the disclosed system. The output from the sensor may be used as feedback to control the action of the intravascular device. In FIG. 1, a sensor 1600 may be used to monitor the patient's body and / or the intravascular device and may provide a sensor output to the control device 1400. For example, the sensor 1600 may be configured as a force meter to measure the force exerted when the intravascular device 1200 is removed from a body structure (e.g., a blood vessel) by the control device 1400 or a user. If the force measured by sensor 1600 exceeds a threshold, an alarm may be generated to notify a user (e.g., via a user interface of control device 1400, or via peripheral device 1800, or via an element of sensor 1600, such as vibration of sensor 1600) and / or an automated safety protocol may be executed by control device 1400 to reduce the magnitude of the force exerted by the intravascular device or to stop the action. For example, an automated safety protocol for retrieving an intravascular device from a body structure may close an expandable mesh segment or an inflatable balloon to reduce the magnitude of the force exerted by the intravascular device before continuing the action.
[0063]
[0084] The disclosed embodiments may include determining at least one characteristic of the first force based on an input indicative of the first desired action. For example, the disclosed system may include at least one processor configured to determine at least one characteristic of the first force based on an input indicative of the first desired action. In some embodiments, the "first force" may refer to a force exerted by the control device 1400 on the first proximal portion of the intravascular device 1200 to cause the second distal portion of the intravascular device to perform the first desired action. The at least one characteristic of the first force may include at least one of a magnitude of the first force, a duration of the first force, or a direction of the first force.
[0064]
[0085] 4A-4D, the resulting input may indicate a desired expansion size of the expandable mesh segment 4210 (e.g., the input may indicate that the mesh segment 4210 is to be expanded to have an outer diameter of 2 mm to 15 mm, such as, but not limited to, 2 mm, 2.5 mm, 3 mm, 3.5 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, etc.). In some embodiments, the at least one processor may determine a current size of the mesh segment 4210 from imaging data (e.g., from the peripheral device 1800), sensor output data from the sensor 1600, and / or historical data of movement of the intravascular device 1200, etc. Based on the current size of the mesh segment 4210, the at least one processor may determine both a direction of movement (e.g., expansion versus contraction of the mesh segment) and an extent of movement (e.g., a change in outer diameter of the mesh segment 4210, or a change in distance between the distal end 4212 and the proximal end 4214 of the mesh segment) to achieve a desired size of the mesh segment 4210. Additionally, the at least one processor may determine or obtain a ratio between the movement of the mesh segment 4210 (e.g., a change in outer diameter of the mesh segment 4210, or a change in distance between the distal end 4212 and the proximal end 4214 of the mesh segment) and a corresponding movement of the actuator 2420 by the device movement mechanism 2412. Based on this information, the at least one processor may determine characteristics of a first force, including a direction and a magnitude, to be exerted by the device movement mechanism 2412 on the actuator 2420 to adjust the mesh segment 4210 to have the indicated size (i.e., to perform a first desired action by the intravascular device 1200 within the body structure).
[0065]
[0086] 5A-5B, the obtained input may indicate a desired bending curvature of the distal end 5240 of the intravascular device 1200b (e.g., guidewire) for advancement through a tortuous anatomical structure. In some embodiments, the at least one processor may determine a current bending curvature of the distal end 5240 from imaging data (e.g., from the peripheral device 1800), sensor output data from the sensor 1600, and / or historical data of movement of the intravascular device 1200, etc. Based on the current bending curvature of the distal end 5240, the at least one processor may determine both a direction of movement of the core wire (e.g., pulling vs. pushing the core wire to bend or straighten the distal end 5240, respectively) and a speed of movement of the core wire. Additionally, the at least one processor may determine or obtain a ratio between the movement of the core wire and the corresponding movement of the actuator 2420 by the device movement mechanism 2412. Based on this information, the at least one processor may determine characteristics of a first force, including direction and magnitude, to be applied to the actuator 2420 by the device movement mechanism 2412 to adjust the distal end 5240 to have the indicated bending curvature (i.e., to perform a first desired action by the intravascular device 1200 within the body structure).
[0066]
[0087] The disclosed embodiments may include causing a control device of the intravascular device to apply a first force to a first portion of the intravascular device based on at least one determined characteristic of the first force. For example, the disclosed system may include at least one processor configured to cause a control device of the intravascular device to apply a first force to a first portion of the intravascular device based on at least one determined characteristic of the first force. As used herein, a "first portion of the intravascular device" may include a portion of the intravascular device 1200 that interacts with and is manipulated by the control device 1400. One example of a first portion of the intravascular device includes the actuator 2420 of FIG. 2, which may include a control wire or other steering mechanism that is manipulated by the control device 1400 to achieve a desired action by the intravascular device 1200. For example, in FIGS. 4A-4D, the "first portion" of the intravascular device 1200a may include a proximal end of the control wire 4230 operatively connected to the device movement mechanism 2412. 5A-5B and 6, the "first portion" of intravascular device 1200b and intravascular device 1200c may include the proximal end of the control wire of each intravascular device, which may be manipulated by device movement mechanism 2412 to cause bending and straightening of bendable portion 5202 and bendable portion 6202. In disclosed embodiments, the first portion of the intravascular device may be located outside the patient's body. For example, the first portion of the intravascular device may be connected to, or at least located near, control device 1400. Control device 1400 may also be located outside the patient's body during a procedure with intravascular device 1200.
[0067]
[0088] In disclosed embodiments, the action of a first force on a first portion of the intravascular device may cause a second portion of the intravascular device to perform a first desired action within a body structure. In some embodiments, the "second portion of the intravascular device" may include a portion of the intravascular device 1200 that is located at or near a treatment site during a procedure with the intravascular device. This may include a distal portion or distal end of the intravascular device 1200. In some embodiments, the "second portion of the intravascular device" may include a portion of the intravascular device 1200 that is used to navigate through a tortuous anatomical structure (e.g., a distal bendable section). In disclosed embodiments, the second portion of the intravascular device may include a structure that is used to perform a desired treatment at the treatment site. For example, the second portion of the intravascular device may include at least one of a distal portion of a guidewire, a distal portion of a guide catheter, a distal portion of a catheter (e.g., a distal portion of an aspiration catheter), an expandable distal portion of the intravascular device (e.g., a mesh segment), or a distal inflatable section of the intravascular device (e.g., an inflatable balloon). To illustrate, the second portion of the intravascular device 1200 may include the expandable mesh segment 4210 of FIGS. 4A-4D, the bendable section 5202 of the guidewire of FIGS. 5A and 5B, and the deflectable segment 6202 of the catheter of FIG.
[0068]
[0089] In disclosed embodiments, the input indicative of the first desired action may be indicative of a navigation target. As used herein, a navigation target may refer to a target site within a patient's body where a particular portion of an intravascular device (e.g., a distal portion, such as a distal end) is to be placed. In some embodiments, the navigation target may be indicated by coordinate data, path data, or other data. The at least one processor may be configured to determine at least one characteristic of the first force based on the navigation target. For example, the at least one processor may determine a current position of intravascular device 1200 (e.g., from imaging data from peripheral device 1800, from sensor output from sensor 1600, and / or from movement history data of intravascular device 1200) and calculate a distance and / or navigation path for advancing intravascular device 1200 to the navigation target. The at least one processor may determine a characteristic of the first force, such as a magnitude and a direction of the first force to be applied as a function of time to guide intravascular device 1200 through the patient's body to reach the navigation target.
[0069]
[0090] In disclosed embodiments, at least one characteristic of the first force may be determined based on information about at least one of the intravascular device, the body structure to be treated, the location of the body structure to be treated, the indication to be treated (e.g., a stenosis in the body structure or an occlusion in the body structure), or other structures at or near the treatment site. For example, at least one characteristic of the first force may be determined based on characteristics of the intravascular device or the location of the intravascular device within the body structure. The characteristics of the intravascular device may include information about the device's current size (e.g., diameter), configuration (e.g., expanded, contracted, bent, straightened, inflated, retracted), or position, which may be used as input to determine the force required to move the intravascular device from its current position and configuration to a desired position and configuration. Additionally, information about the location of the intravascular device within the body structure may indicate further movement required to move the intravascular device to the navigation target, may indicate that the intravascular device may deviate from the desired treatment site and contact tissue that is not to be treated, or may indicate that the intravascular device has deviated from the desired navigation path required to reach the navigation target. The characteristics of the intravascular device may also include information regarding individual components contained within the intravascular device (e.g., one or more markers indicating one or more portions of the intravascular device), the materials of the intravascular device, or mechanisms for activating or deactivating the functions of the intravascular device.
[0070]
[0091] Additionally or alternatively, at least one characteristic of the first force may be determined based on characteristics of the body structure, such as a size or shape of the body structure, a curvature or flatness of the body structure, a diameter of the body structure, a type of tissue forming the body structure, and a medical or surgical history of the body structure. Additionally or alternatively, at least one characteristic of the first force may be determined based on a type of occlusion or a type of stenosis in the body structure. For example, the type of occlusion may include a thrombus, plaque, or a foreign body. Further, the type of stenosis in the body structure may include a vasospasm or atherosclerosis (e.g., intracranial arterial stenosis). Based on the type of occlusion or stenosis, the at least one processor may determine a magnitude of the first force (e.g., because some types of occlusions require more force to overcome), as well as a direction and timing of the first force to achieve a movement of the second portion of the intravascular device that is most appropriate for the type of occlusion or stenosis.
[0071]
[0092] In disclosed embodiments, the at least one processor may be configured to determine at least one characteristic of a first force to effect movement at a substantially constant velocity on the second portion of the intravascular device. For example, the at least one processor may determine an amount of force to be applied to the actuator 2420 to overcome any resistance at the treatment site (e.g., due to a thrombus or occlusion contacting the second portion of the intravascular device) and achieve a substantially constant velocity, as well as a direction of the first force corresponding to the direction of movement of the intravascular device. The at least one processor may also determine a duration of application of the first force such that the intravascular device moves at a substantially constant velocity for a desired length of time.
[0072]
[0093] Additionally or alternatively, the at least one processor may be configured to determine at least one characteristic of a first force to expand or contract the second portion of the intravascular device (e.g., expandable mesh 4210). For example, the at least one characteristic may include a direction of the first force to achieve a desired one of expansion or contraction of the second portion of the intravascular device 1200, e.g., to a predetermined diameter size. Additionally or alternatively, the at least one processor may be configured to determine at least one characteristic of a first force to perform a repetitive motion (also referred to as a pulsating motion) on the second portion of the intravascular device. For example, to perform a repetitive massage motion on the expandable mesh 4210, the at least one processor may determine a corresponding repetitive first force to be applied to the actuator 2420 to achieve a predetermined expansion and / or contraction diameter for maximal clot integration. The at least one characteristic of the repetitive first force may include a duration of each cycle of the repetitive first force, a direction of movement of the actuator 2420 as a function of time, and a magnitude of force to be applied to the actuator 2420 to achieve a desired type, duration, and number of repetitions of repetitive motion by the expandable mesh 4210. In some embodiments, the duration of each cycle of the repetitive first force may be between 1 second and 3 minutes, including but not limited to 1 second, 5 seconds, 10 seconds, 15 seconds, 20 seconds, 30 seconds, 60 seconds, 90 seconds, 120 seconds, 150 seconds, 180 seconds, etc. Additionally or alternatively, the at least one processor may be configured to determine at least one characteristic of the first force to bend or straighten the second portion of the intravascular device. For example, the at least one processor may determine a direction of the first force to achieve a desired one of bending or straightening the intravascular device, and a magnitude of force required to change the curvature of the second portion of the intravascular device. Additionally or alternatively, the at least one processor may be configured to determine at least one characteristic of a first force to expand or contract the second portion of the intravascular device.
[0073]
[0094] In some embodiments, the at least one processor may utilize medical image data (e.g., image data obtained as an input) to determine a characteristic of the first force. For example, the at least one processor may be configured to calculate a convolution of the at least one medical image and derive a convolution value. The at least one processor may be configured to determine the at least one characteristic of the first force based on the derived convolution value. For example, a convolution of at least a portion of the medical image may be calculated and a digital signal may be generated based on the calculated convolution value.
[0074]
[0095] Further, the at least one processor may use the medical image data to determine feedback regarding the treatment site, feedback regarding the intravascular device, and / or feedback regarding the anatomical position of the intravascular device within the body structure. The determined feedback may be used to determine a characteristic of the first force. For example, the at least one processor may be configured to detect at least one of the body structure or a second portion of the intravascular device within the body structure within the at least one medical image. The at least one processor may determine whether the second portion of the intravascular device is in a correct position within the body structure and whether the intravascular device has a correct size or configuration based on the information detected from the at least one medical image. The at least one processor may be configured to determine at least one characteristic of the first force based on the detection of at least one of the body structure or the second portion of the intravascular device within the body structure. For example, the at least one processor may determine from the image data whether an adjustment of the position, size, or configuration of the intravascular device is required. The at least one processor may then determine a characteristic of the first force to achieve the desired adjustment.
[0075]
[0096] In disclosed embodiments, the at least one processor may be configured to analyze the at least one medical image and determine a position of the second portion of the intravascular device relative to a second object. For example, the second object may include a blood clot or other obstruction, a portion of another device (e.g., the second intravascular device), a site of a vascular stenosis, or another anatomical structure. The at least one processor may be configured to determine at least one characteristic of a first force based on the determined position of the second portion of the intravascular device relative to the second object. For example, the at least one processor may determine at least one characteristic of a first force for the second portion of the intravascular device to avoid the second object, as needed. Alternatively, the at least one processor may determine at least one characteristic of a first force for the second portion of the intravascular device to perform a desired interaction with the second object, such as by removing a detected blood clot or radially expanding a site of a vascular stenosis.
[0076]
[0097] As discussed above, the obtained input indicative of the first desired action may include data derived from a sensor output. In a disclosed embodiment, the sensor output may be indicative of a force applied to remove the intravascular device from the body structure. For example, the sensor device 1600 may include a force meter configured to measure the magnitude of the force applied by the intravascular device 1200 as it is retrieved from the body structure. Thus, when the intravascular device 1200, such as a device having an expandable mesh 4210, expands and contacts the inner wall 4010 of the blood vessel, the force applied to retrieve the intravascular device 1200 may damage the blood vessel wall. Additionally or alternatively, the force applied to retrieve the intravascular device 1200 through a tortuous anatomical structure may result in the applied force causing tissue damage. At least one processor may receive the output from the force meter 1600 and identify when the force applied to remove the mesh 4210 from the blood vessel 4010 exceeds a predetermined safety threshold. In some embodiments, if a threshold is exceeded, at least one processor may output an alert (e.g., via a user interface of control device 1400, via peripheral device 1800, or via an element of sensor 1600) and / or may alter the operation of the intravascular device within the body (e.g., by reducing the application of force by the intravascular device or by ceasing the action).
[0077]
[0098] In disclosed embodiments, the at least one processor may be configured to determine that the first desired action of the intravascular device in the body structure exceeds a predetermined threshold based on the obtained input. For example, the threshold may indicate a maximum force application by the intravascular device to the body structure or a minimum distance that must be maintained between the intravascular device and tissue that should not be treated with the intravascular device. In some embodiments, the at least one processor may determine that the threshold is exceeded based on an output from a sensor device 1600, such as a force meter as described above. Additionally or alternatively, the at least one processor may utilize image data to evaluate the respective positions of the intravascular device and the patient's anatomical structures at and around the treatment site. The at least one processor may determine that the threshold is exceeded if the intravascular device is determined to be in an incorrect position or too close to an anatomical structure that should not be treated.
[0078]
[0099] In disclosed embodiments, the at least one processor may be configured to output an alert based on a determination that the first desired action of the intravascular device in the body structure exceeds a threshold. For example, the at least one processor may output a graphical, audio, and / or sensory alert (e.g., vibration) to the user via a user interface of the control device 1400, via the peripheral device 1800, or via an element of the sensor 1600. Additionally or alternatively, the at least one processor may be configured to modify at least one parameter of the first force based on a determination that the first desired action of the intravascular device in the body structure exceeds a threshold. For example, the at least one processor may cause the device movement mechanism 2412 to reduce the magnitude of the force applied to the actuator 2420, which in turn reduces the force applied to the body structure by the intravascular device 1200. Alternatively, the at least one processor may cause the device movement mechanism 2412 to stop all movement of the intravascular device such that application of dangerous forces or movement of the intravascular device is immediately stopped.
[0079]
[0100] In disclosed embodiments, it may be desired to perform a second desired action with the intravascular device after performing a first desired action. For example, each action may be considered a step of a surgical procedure, with the steps proceeding in succession with one another. Thus, the at least one processor may be configured to determine at least one characteristic of a second force based on an obtained input indicative of a second desired action of the intravascular device within the body structure. In some embodiments, the at least one characteristic of the second force may be determined based on the same input as the first force described above. Additionally or alternatively, the at least one characteristic of the second force may be determined based on a second input. Similar to the first input described above, the second input may include at least one of an input from a user performing a procedure with the intravascular device, first data of at least one medical image, or second data obtained from at least one sensor output. In disclosed embodiments, the at least one processor may be configured to cause the control device of the intravascular device to apply a second force after causing the control device to apply a first force to a first portion of the intravascular device. Similar to application of the first force described above, the at least one processor can cause the control device of the intravascular device to apply a second force based on the determined at least one characteristic of the second force. For example, in Figures 1-2, the at least one processor can cause the control device 1400 to apply a second force to the intravascular device 1200 based on the determined at least one characteristic of the second force.
[0080]
[0101] In some embodiments, the second desired action of intravascular device 1400 may be performed by exerting a second force on a first portion of intravascular device (i.e., the same portion of intravascular device 1400 that is controlled to perform the first desired action). For example, control device 1400 may be configured to exert a first force and a second force on actuator 2420, which may exert a force corresponding to intravascular device 1200. Alternatively, control device may exert a second force on a third portion of intravascular device that is different from the first portion of intravascular device. For example, in some embodiments, control device 1400 may include multiple actuators 2420, each of which may be connected to and control different parts of intravascular device 1200. In such an embodiment, two separate actuators 2420 may correspond to the first and third portions of intravascular device. Furthermore, two different parts of intravascular device 1200, each of which is controlled by a different actuator, may correspond to the second and fourth portions of intravascular device. In disclosed embodiments, the action of the second force can cause at least one of the second portion of the intravascular device or the fourth portion of the intravascular device to perform a second desired action within a body structure. For example, in some embodiments, the action of the first force and the second force can cause the same part of the intravascular device 1200 to perform the first desired action and the second desired action. For example, the first force and the second force can be applied to the same actuator 2420 to cause movement of the same part of the intravascular device 1200. Alternatively, the action of the first force and the second force can cause two different parts of the intravascular device 1200 (specifically, the second portion and the fourth portion, respectively) to perform the first desired action and the second desired action. For example, the intravascular device 1200 may include multiple actuators 2420 that control different parts of the device (e.g., that may cause bending of the bendable segments 5202 of Figures 5A-5B in opposite directions, or that may cause bending of two separate bendable segments 5202 within the same intravascular device of Figures 5A-5B).The first and second forces can be applied to different actuators 2420 to cause different actions by the intravascular device (e.g., bending the bendable segment 5202 in different directions, either in successive steps or simultaneously).
[0081]
[0102] In disclosed embodiments, the second desired action may include at least one of completing a first desired action of the intravascular device or performing another desired action of the intravascular device different from the first desired action. In disclosed embodiments, the second desired action may include contraction of an expanded distal portion of the intravascular device. For example, the first desired action may include expanding the mesh segment 4210, while the second desired action may include contracting the expanded mesh segment 4210. In another example, the first desired action may include expanding the mesh segment 4210 to a diameter, while the second desired action may include expanding the mesh segment 4210 to a second diameter (e.g., to a fully expanded diameter). In yet another example, the first desired action may include contracting the mesh segment 4210 to a diameter, while the second desired action may include contracting the mesh segment 4210 to a second diameter (e.g., to a fully collapsed diameter). Additionally or alternatively, the second desired action may include removing a second portion of the intravascular device from the body structure. For example, the user may indicate an action in a second direction by pressing button 3436 in FIG. 3A or 3B, which may cause the expanded mesh segment 4210 to contract to its fully contracted state and be removed from the patient's body.
[0082]
[0103] In some embodiments, at least one characteristic of the second force may be determined prior to exerting the first force on the first portion of the intravascular device, such as in a sequence of steps of a predetermined surgical plan. Additionally or alternatively, at least one characteristic of the second force may be determined based on a second input from a user performing a procedure using the intravascular device. For example, the user may provide the second input using one of the buttons on the control handle 1400a or control handle 1400b of FIGS. 3A-3B. Additionally or alternatively, the second input may be received after having the control device exert the first force on the first portion of the intravascular device. For example, the second input may be received from the user as data from the sensor 1600, as data from the imaging device 1800, and / or as data from an additional imaging device (not shown) that provides feedback regarding the performance of the first desired action by the intravascular device, as described above. For example, at least one characteristic of the second force may be determined based on analysis of at least one medical image taken (e.g., by peripheral imaging device 1800 or by an additional imaging device) after the control device applies a first force to a first portion of the intravascular device.
[0083]
[0104] Similar to determining at least one characteristic of the first force described above, the at least one processor may be configured to determine at least one characteristic of the second force to cause the second portion of the intravascular device to perform a movement (e.g., at a substantially constant speed), to expand the second portion of the intravascular device, to inflate the second portion of the device, to contract the second portion of the device, to contract the second portion of the intravascular device, to cause the second portion of the intravascular device to perform a repetitive motion, to bend the second portion of the intravascular device, and / or to straighten the second portion of the intravascular device.
[0084]
[0105] Returning to FIGS. 1-3B, embodiments relating to control device 1400 will now be described. In some embodiments, a control device for controlling movement of an intravascular device may be provided. The control device may be configured to be disposed outside the patient's body. For example, control device 1400 may be configured to control the movement of intravascular device 1200a of FIGS. 4A-4D by moving control wire 4230 proximally and / or distally, thereby causing expansion and contraction of mesh segment 4210. Similarly, control device 1400 may be configured to control the movement of intravascular device 1200b and intravascular device 1200c by moving their respective control wires, thereby causing bending and / or straightening of deflectable segment 5202 and deflectable segment 6202. In some embodiments, the control device may include an input mechanism configured to receive input from a user. Examples of input mechanisms include the arrangement of at least one input structure (e.g., button) shown in FIGS. 3A and 3B. Additionally or alternatively, the input mechanism of the control device 1400 may include at least one of a button, a keyboard, a computer mouse, a lever, a joystick, or a touch screen.
[0085]
[0106] In disclosed embodiments, the control device may include a device movement mechanism configured to control at least one movable portion of the intravascular device. For example, and as described above, the device movement mechanism 2412 may be configured to control the expansion and contraction of the expandable mesh 4210, the bending and straightening of the deflectable segment 5202 of the guidewire, and the bending and straightening of the deflectable segment 6202 of the catheter. The movable portion of the intravascular device may be configured to be positioned within the patient's body, including while the movable portion moves under the control of the control device. In disclosed embodiments, the control device may also include at least one processor, an example of which may include the controller 2414 shown in FIG. 2.
[0086]
[0107] In some embodiments, at least one processor of the control device (e.g., controller 2414) may be configured to actuate the device movement mechanism in response to a first input. The first input may be received from a user via an input mechanism of the control device (e.g., one of the buttons shown in FIGS. 3A and 3B). Additionally or alternatively, the first input may be received from a user via a user interface of the peripheral device 1800 (examples of which may include a touch screen or a GUI). For example, a physician may use the peripheral device 1800 to digitally control a treatment with the intravascular device 1200. The peripheral device 1800 may, in some embodiments, provide a larger user interface than the control device 1400. Additionally or alternatively, the first input may be obtained from the sensor device 1600 (as described above). Additionally or alternatively, the first input may correspond to computer-executable instructions for treatment with the intravascular device 1200 stored in memory (e.g., a memory component of the controller 2414).
[0087]
[0108] In some embodiments, at least one processor of the control device (e.g., controller 2414) may be configured to actuate a device movement mechanism in response to a first input to move at least one movable part of the intravascular device to move the intravascular device to a first configuration. For example, the first input may indicate a desired action or movement of the intravascular device (e.g., a user may press one of buttons 3430 or 3432 shown in FIG. 3A, which may indicate an instruction to the control device 1400 to expand or contract an expandable mesh or bend or straighten a guidewire or catheter). In response, the device movement mechanism 2412 may perform the requested movement of the intravascular device 1200 (e.g., by manipulating a control wire or other actuator of the intravascular device). As another example, the first input may indicate a desired configuration of the intravascular device (e.g., a user may press one of buttons 3444-3450 in FIG. 3B, which may indicate a particular placement of the intravascular device or an action by the intravascular device (e.g., a desired expanded diameter or shape of the expandable mesh 4210, such as a fully expanded state, a fully contracted state, a 90% expanded state, an 80% expanded state, etc., a desired expansion time (e.g., the expansion occurs over a time period ranging from 10 seconds to 3 minutes), or a desired contraction time (e.g., the contraction occurs over a time period ranging from 10 seconds to 3 minutes)), or alternatively, a characteristic of a treatment site within the patient's body to be treated with the intravascular device 1200 (e.g., a diameter of a body structure to be treated with the intravascular device, a type of stenosis or occlusion to be treated with the intravascular device, such as a thrombus, vasospasm, plaque, or a type of clot to be treated with the intravascular device, such as thrombus and clots containing fatty or calcium deposits)). In response, the device movement mechanism may control intravascular device actuators 2420 (eg, control wires) to move intravascular device 1200 into a shape or configuration that corresponds to the received input.
[0088]
[0109] In disclosed embodiments, at least one processor of the control device (e.g., controller 2414) may be configured to actuate a device movement mechanism in response to a second input, such that intravascular device 1200 may be moved to a second configuration that is different from the first configuration. For example, during the course of a procedure performed by intravascular device 1200, a series of inputs may be received. In response to each received input, the processor of the control device may move intravascular device 1200 to a different configuration, thereby performing the desired procedure.
[0089]
[0110] In some embodiments, at least one processor (e.g., controller 2414) of the control device may be configured to actuate device movement mechanism 2412 to move the first and second movable portions of intravascular device 1200 in the same direction. According to an embodiment including an expandable mesh device shown in FIGS. 4A-4D, device movement mechanism 2412 may be configured to move both control wire 4230 and elongate shaft 4220 of the expandable mesh device. Control wire 4230 may be rigidly attached to distal end 4212 of the mesh, while shaft 4214 may be rigidly attached to proximal end 4214 of the mesh. As a result, the two ends of the mesh may be movable and thus manipulated under the control of device movement mechanism 2412 to achieve a desired shape and / or configuration of mesh 4210. In some embodiments, the device movement mechanism 2412 can move the distal end 4212 and the proximal end 4214 in the same direction (e.g., can move both distally during advancement of the mesh 4210 to the treatment site). Additionally or alternatively, at least one processor (e.g., controller 2414) of the control device can be configured to actuate the device movement mechanism 2412 to move a first movable part of the intravascular device in a first direction and move a second movable part of the intravascular device in a second direction opposite the first direction. For example, the device movement mechanism 2412 can expand the mesh 4210 and move the distal end 4212 in a proximal direction while also moving the proximal end 4214 in a distal direction. Additionally or alternatively, at least one processor (e.g., controller 2414) of the control device may be configured to actuate device movement mechanism 2412 to move at least one movable portion of the intravascular device while another portion of the intravascular device remains stationary relative to the control device. For example, device movement mechanism 2412 may also be configured to move one of the distal end 4212 and proximal end 4214 of the mesh while the other end of the mesh remains stationary. With this alternative approach, mesh 4210 may be expanded and / or contracted.
[0090]
[0111] In some embodiments, at least one processor (e.g., controller 2414) of the control device may be configured to actuate device movement mechanism 2412 in response to a third input to move core wire 4230 of the intravascular device to exert a pulsating force (e.g., a rhythmic massaging motion) on the interior surface of the body structure. For example, the pulsating motion may be activated by button 3434 of control device 1400a shown in FIG. 3A. The pulsating motion may be optimized to improve capture between intravascular device 1200 and blood clot 4012 or other obstruction by varying the motion of mesh 4210 of the intravascular device from a first position that produces a maximum radial force to a second position that produces a lower force. The frequency of the pulsating motion described above may be in the range of 0.1 Hz to 5 Hz.
[0091]
[0112] In some embodiments, at least one processor (e.g., controller 2414) of the control device may be configured to, in response to a fourth input, actuate drive device movement mechanism 2412 to move core wire (e.g., control wire 4230) in a second direction (e.g., distal direction), thereby contracting mesh 4210 and subsequently retracting the intravascular device from the body structure (which may include a blood vessel). For example, button 3436 (see FIGS. 3A and 3B) on control device 1400 may return intravascular device 1200 to a retrieval position, which may include closing or radial contraction of mesh 4210 of the intravascular device, or, in alternative embodiments, straightening of the guidewire (see FIGS. 5A-5B) or catheter (see FIG. 6) of the intravascular device. Control device 1400 may be configured to retract (or remove) intravascular device 1200 into a delivery catheter and / or out of the patient's body.
[0092]
[0113] According to an embodiment including the guidewire device of FIGS. 5A-5B, at least one processor (e.g., controller 2414) of the control device may be configured to, in response to a first input, actuate the device movement mechanism 2412 to move a core wire (e.g., a control wire, not shown) of the guidewire device in a first direction (e.g., proximally, to the right in FIGS. 5A-5B) while keeping the elongate shaft 5220 of the guidewire device stationary, thereby bending the distal portion 5202 of the guidewire device from a straightened configuration to a first bent configuration. Further, in response to a second input, at least one processor (e.g., controller 2414) of the control device may be configured to actuate the device movement mechanism 2412 to move the core wire of the guidewire device in a second direction opposite to the first direction (e.g., distally, or to the left in Figures 5A-5B) while keeping the elongate shaft 5220 of the guidewire device stationary, thereby bending the distal portion 5202 of the guidewire device from the first bent configuration to one of a straightened configuration or a second bent configuration.
[0093]
[0114] FIG. 7 is a flow chart illustrating an example of a process 7000 for digitally controlling an intravascular device consistent with disclosed embodiments. Process 7000 is provided by way of example, and one of ordinary skill in the art will appreciate various other processes for digitally controlling an intravascular device consistent with the present disclosure. At step 7010, process 7000 may include obtaining an input indicative of a first desired action of an intravascular device within a patient's anatomy. Examples of intravascular devices include an intravascular device including an expandable mesh 4210 of FIGS. 4A-4D, a guidewire including at least one bendable section of FIGS. 5A-5B, and a catheter including at least one bendable section of FIG. 6. At step 7020, process 7000 may include determining at least one characteristic of a first force based on the obtained input. At step 7030, process 7000 may include causing a control device of the intravascular device to apply a first force to a first portion of the intravascular device based on the determined at least one characteristic. In some embodiments, the first portion of the intravascular device may be disposed outside the patient's body. The application of the first force can cause a second portion of the intravascular device (e.g., a portion within the patient's body) to perform a first desired action within the body structure. At step 7040, process 7000 can include obtaining a second input indicative of a second desired action of the intravascular device within the patient's body structure. At step 7050, process 7000 can include determining at least one characteristic of the second force based on the obtained second input. At step 7060, process 7000 can include causing a control device of the intravascular device to apply a second force to the first portion of the intravascular device and / or a third portion of the intravascular device based on the determined at least one characteristic of the second force. The application of the second force can cause the second portion or a fourth portion of the intravascular device (e.g., a portion within the patient's body) to perform a second desired action within the body structure.
[0094]
[0115] FIG. 8 illustrates a graph showing an example of a change in size of expandable mesh 4210 of intravascular device 1200 over time during a partially automated treatment of a body structure with intravascular device 1200, consistent with disclosed embodiments. Partial automation may include some operations performed based on input received from a user (e.g., via one of the control device configurations shown in FIGS. 3A and 3B) and some operations that are automated (i.e., performed by control device 1400 based on preprogrammed instructions without user input). For example, in an embodiment where the intravascular device is a device having expandable mesh 4210, the mesh size may increase during a sheath removal phase of intravascular device 1200. The sheath removal may be performed in response to input from a user. The size of mesh 4210 may increase stepwise during an expansion phase of intravascular device 1200. The expansion may be performed in response to input from a user. The mesh size may vary during a "massage" or pulsating or cyclic phase controlled by automation. Furthermore, the mesh size may decrease and vary during the harvesting phase, which is controlled by the automation. In Fig. 8, the light grey parts of the line graph indicate that actions are performed in response to user input, while the black parts of the line graph indicate that actions are automated.
[0095]
[0116] 9A-9C show examples of graphical user interfaces (GUIs) for display on a computing device of endovascular treatment system 1000, such as peripheral device 1800. The GUIs shown in FIGS. 9A-9C may include user input fields (e.g., buttons) that instruct control device 1400 to perform one or more particular operations with endovascular device 1200. For example, in an embodiment in which the endovascular device is a device having an expandable mesh 4210, buttons on the GUI may cause control device 1400 to expand the mesh, relax the mesh, operate a massage (pulsating or cyclical) mechanism, and advance (return) to a retrieval position (e.g., with the mesh collapsed). The GUI operations shown in FIGS. 9A-9C may also allow a user to select a blood vessel diameter, or a type of clot or other occlusion or stenosis to be treated by endovascular device 1200, an automation option, or an option to insert a maximum size of opening endovascular device 1200. Automation options may include the user pressing an interactive key or button for automatic function of intravascular device 1200 .
[0096]
[0117] As shown in FIG. 9A, the first interactive display may include inputs (e.g., buttons) for the user to instruct the control device 1400 to position and remove the sheath from the intravascular device 1200. The first interactive display of FIG. 9A may also include an interactive selection for expanding the mesh 4210 of the intravascular device. As shown in FIG. 9B, the second interactive display may instruct the control device 1400 to adjust the mesh size of the intravascular device 1200. The second interactive display may include an interactive selection for adjusting the mesh size, such as expanding or relaxing the mesh 4210. The second interactive display may also display whether the intravascular device 1200 is activated. Additionally, the second interactive display of FIG. 9B may display an estimated time until ingestion. As shown in FIG. 9C, the third interactive display may instruct the control device 1400 to remove the intravascular device 1200 from the patient's body. 9C may include interactive selections for adjusting the mesh size, such as expanding or relaxing mesh 4210 of intravascular device 1200. The third interactive display may also display the current mode of intravascular device 1200. Additionally, the third interactive display may display the force measured by sensor 1600.
[0097]
[0118] 10 illustrates one embodiment of a device movement mechanism 2412a of the control device 1400 consistent with disclosed embodiments. The device movement mechanism 2412a may include a motor 10010, a gearbox 10020, a helical or screw gear 10030, a screw gear load 10040, and an encoder 10050. The motor 10010 may be powered by a power source 2416 (see FIG. 2) and controlled by signals received from the controller 2414. The motor 10010 may be operatively connected to the screw gear 10030 by a gearbox 10020. A first end of the screw gear load 10040 may be securely attached to a core wire 10230 (e.g., core wire 4230 in FIGS. 4A-4D) of the intravascular device 1200, while a second end of the screw gear load 10040 may include teeth that engage teeth of the screw gear 10030. The motor 10010 can drive rotation of the screw gear 10030, which can be translated into longitudinal movement (left and right in FIG. 10) of the screw gear load 10040. The longitudinal movement of the screw gear load 10040 can move the core wire 10230 relative to the shaft 10220 of the intravascular device 1200 (e.g., the elongated shaft 4220 of FIGS. 4A-4D, the elongated shaft 5220 of FIGS. 5A-5B, or the elongated sheath 6220 of FIG. 6). The shaft 10220 can be rigidly attached to the control device 1400 or a portion thereof, thus allowing the movement of the core wire 10230 to be translated into the performance of a desired action of the intravascular device 1200. The encoder 10050 can sense the speed and direction of rotation of the screw gear 10030 and convert the detected rotation into an electrical signal that can be output to the controller 2414 as a form of feedback regarding the detected speed and direction. The controller 2414 can receive a feedback signal from the encoder 10050 and can control the operation of the motor 10010 based on the signal (e.g., by increasing or decreasing the speed of the motor 10010, by changing the gears of the gearbox 10020 connecting the motor 10010 to the screw gear 10030, or by starting or stopping the drive of the motor 10010).
[0098]
[0119] 11 illustrates another embodiment of a device movement mechanism 2412b of a control device 1400 consistent with disclosed embodiments. The device movement mechanism 2412b may include a motor 11010 and a gearbox 11020 configured to drive rotation of a pulley 11070, which may drive a belt 11060 connected to a core wire 10230. Thus, the core wire 10230 may be moved relative to the intravascular device shaft 10220 by connection of the core wire to the drive belt 11060 (as detailed above). The device movement mechanism 2412b may also include an encoder 11050, which may provide feedback to the controller 2414 regarding the speed and direction of rotation of the drive belt 11060 (as described above).
[0099]
[0120] 12 illustrates another embodiment of a device movement mechanism 2412c of a control device 1400 consistent with disclosed embodiments. The device movement mechanism 2412c adds a mechanism for moving the intravascular device shaft 10220 (in addition to moving the core wire 10230) and may be configured similarly to the device movement mechanism 2412a of FIG. 10. The device movement mechanism 2412c may include a second screw gear 12032 and a gear wheel 12034 connecting the screw gear 10030 to the second screw gear 12032. The second screw gear 12032 may be connected to the intravascular device shaft 10220 via a rigid connector 12036 and may move the shaft 10220 in response to corresponding movement of the second screw gear 12032. As the motor 10010 drives the rotation of the screw gear 10030 and the corresponding movement of the core wire 10230, the gear wheel 12034 may convert the rotation of the screw gear 10030 into a corresponding axial (left-right in FIG. 12) movement of the second screw gear 12032. In some embodiments, the second screw gear 12032 may translate in the opposite direction to the screw gear load 10040, with the magnitude of their respective translations depending on the configuration of the gear wheel 12034. For example, if the motor 10010 drives the screw gear load 10040 to translate in a distal direction (right in FIG. 12), the second screw gear 12032 may be driven to translate in a proximal direction (left in FIG. 12), and vice versa. A connection between the second screw gear 12032 and the intravascular device shaft 10220 via a rigid connector 12036 allows translation of the second screw gear 12032 to cause a similar translation of the shaft 10220. As a result, both the core wire 10230 and the shaft 10220 can be moved in opposite directions by the motor 10010. In some embodiments including an expandable mesh 4210, the core wire 10230 can be connected to the mesh distal end 4212 (or a distal tip 4240 that can be securely attached to the mesh distal end 4212), while the shaft 10220 can be connected to the mesh proximal end 4214.Thus, when the device movement mechanism 2412c is driven by the motor 10010, the distal end 4212 and the proximal end 4214 of the mesh may be driven together or apart, respectively causing an expansion or contraction of the mesh 4210. In some embodiments, the ratio of movement between the screw gear load 10040 and the second screw gear 12032 (and thus the ratio of movement between the core wire 10230 and the shaft 10220) may depend on the selection of the gear wheel 12034. In some embodiments, the control device controller 2414 may be configured to adjust the ratio of movement between the core wire 10230 and the shaft 10220 by changing the gear wheel 12034 to a different gear wheel, which changes the ratio of axial movement between the screw gear load 10040 and the second screw gear 12032 (and thus the ratio of movement of each of the core wire 10230 and the shaft 10220).
[0100]
[0121] 13 illustrates another embodiment of a device movement mechanism 2412d of a control device 1400 consistent with disclosed embodiments. The device movement mechanism 2412d adds a mechanism for moving the intravascular device shaft 10220 (in addition to moving the core wire 10230) and may be configured similarly to the device movement mechanism 2412b of FIG. 11. The device movement mechanism 2412c may include a rigid connector 13080 connecting the drive belt 11060 to the intravascular device shaft 10220. Thus, as the motor 11010 drives the belt 11060 to cause movement of the core wire 10230, the rigid connector 13080 can transfer rotation of the belt 11060 to the intravascular device shaft 10220, thus causing simultaneous, equal, and opposite movement of the core wire 10230 and shaft 10220.
[0101]
[0122] Consistent with disclosed embodiments, a control device 1400 may be provided for controlling the intravascular device 1200, the control device being configured to control the movement of multiple moving parts of the intravascular device 1200. For example, the control device 1400 may include a first mechanism for controlling the shaft 10220 of the intravascular device and a second mechanism (e.g., a control wire) for controlling the core wire 10230 of the intravascular device. Examples of the first mechanism may include the rigid connector 12036 of FIG. 12 and the rigid connector 13080 of FIG. 13. Examples of the second mechanism may include the screw gear load 10040 of FIG. 10 and FIG. 12 and the drive belt 11060 of FIG. 11 and FIG. 13. In disclosed embodiments, the control device 1400 may be configured to actuate the first mechanism and the second mechanism in response to a first input from a user. For example, the input may come from a button or other user input mechanism of the control device 1400 (e.g., a button shown in FIG. 3A or 3B). In response to a first input, the control device 1400 may actuate the first mechanism and the second mechanism to move the shaft 10220 of the intravascular device a first distance in a first direction (e.g., distal direction) and move the core wire 10230 of the intravascular device a second distance in a second direction (e.g., distal direction) opposite the first direction. The first and second directions may be opposite, e.g., when the motor 10010 drives the movement of the core wire 10230 in a distal direction, the motor 10010 may also drive the movement of the shaft 10220 in a proximal direction, and vice versa. In some embodiments, the first and second mechanisms of the control device 1400 may be configured to move the shaft 10220 and the core wire 10230 simultaneously, such as in the embodiments shown in Figures 12 and 13. Additionally or alternatively, the first and second mechanisms of the control device 1400 may be configured to move the shaft 10220 and the core wire 10230 sequentially (i.e., with movement of one occurring before movement of the other).In the disclosed embodiment, the control device 1400 may be configured to actuate the first mechanism and the second mechanism in response to a single input from a user (e.g., by the user pressing a single button on a user interface of the control device 1400, such as the button shown in Figures 3A-3B).
[0102]
[0123] In some embodiments, the first distance (i.e., the distance of travel of the shaft 10220) may be equal in magnitude to the second distance (i.e., the distance of travel of the core wire 10230). Additionally or alternatively, one of the first and second distances may be greater than the other. Additionally or alternatively, the controller 2414 of the control device 1400 may be configured to controllably adjust the ratio between the displacement of the shaft 10220 (e.g., the first distance) and the corresponding displacement of the core wire 10230 (e.g., the second distance). For example, the control device 1400 may vary the gear wheel 12034 in the embodiment of FIG. 12, which may adjust the ratio between the distance the core wire 10230 travels and the distance the shaft 10220 travels when both the core wire and the shaft are driven by the motor 10010. As a result, at least one processor (e.g., controller 2414) of the control device 1400 can be configured to adjust the ratio between the displacement of a first movable part of the intravascular device (e.g., mesh proximal end 4214) by the device movement mechanism 2412 and the corresponding displacement of a second movable part of the intravascular device (e.g., mesh distal end 4212) by the device movement mechanism 2412.
[0103]
[0124] In some embodiments, the control device 1400 may be further configured to actuate the first mechanism and the second mechanism in response to a second input from a user, such as during a procedure performed by the intravascular device 1200. In response to the second input, the control device 1400 may actuate the first mechanism and the second mechanism to move the shaft 10220 a third distance in a first direction (e.g., proximally) and move the core wire 10220 a fourth distance in a second direction (e.g., distally), where the third distance is different from the first distance and the fourth distance is different from the second distance. For example, the second input may indicate a smaller scale of movement than the first input, such that the first distance and the second distance may be greater than the third distance and the fourth distance, respectively. In some embodiments, the ratio between the second distance and the first distance may be substantially the same as the ratio between the fourth distance and the third distance (such as when the same gear wheel 12034 is used). In alternative embodiments, each input from the user (i.e., the first input and the second input) may be associated with a respective magnitude. In such an example, the ratio between the third distance and the first distance may be substantially the same as the ratio between the magnitude associated with the second input and the magnitude associated with the first input. For example, the first input may indicate a larger scale movement (i.e., a larger displacement of both the shaft 10220 and the core wire 10230) than the second input, such as where the magnitudes of each of the first input and the second input are 2 and 1, respectively. (This may occur, for example, by the user holding down the activation button 3430 twice as long on the first input as on the second input, which may correspond to a magnitude of "2" for the first input and a magnitude of "1" for the second input.) The corresponding movement of the shaft 10220 in response to the first input and the corresponding movement of the shaft 10220 in response to the second input thus have a ratio of 2:1. Similarly, the corresponding movement of core wire 10230 in response to a first input and the corresponding movement of core wire 10230 in response to a second input therefore also have a 2:1 ratio.
[0104]
[0125] In disclosed embodiments, the control device 1400 may be configured to actuate the first and second mechanisms, move the shaft 10220 of the intravascular device in a second direction (e.g., proximally), and release the core wire 10230 of the intravascular device in response to a third input from a user. For example, the third input may indicate a complete contraction or "collapse" of the intravascular device 1200. By releasing the core wire 10230 and moving the shaft 10220 proximally, the control device 1400 may move the intravascular device 1200 (e.g., mesh segments 4210) to a most contracted, low-profile configuration. This may enable removal of the intravascular device 1200 from the treatment site (e.g., when button 3436 on the control device of FIGS. 3A-3B is pressed).
[0105]
[0126] Consistent with disclosed embodiments, FIG. 14 illustrates an endovascular treatment system 14000 configured to magnetically control an endovascular device 1200. The system 14000 may include a control device 14400 that may be configured to control the action of the endovascular device 1200 at a treatment site within a patient's body. The control device 14400 may include a control device body 14410 and may be configured as a portable, disposable, handheld device and may be configured to be placed outside the patient's body. The control device 14400 may include a device movement mechanism configured to control at least one adjustable portion of the endovascular device 1200. Examples of at least one adjustable portion may include the expandable mesh 4210 of FIGS. 4A-4D, the bendable segment 5202 of the guidewire shown in FIGS. 5A-5B, and the deflectable segment 6202 of the catheter shown in FIG. 6. In embodiments including an expandable mesh 4210, the intravascular device may be a stent retriever (e.g., a clot retrieval device) or may be an adjustable mesh device (e.g., configured to provide support to a blood vessel during treatment of an aneurysm or configured to expand a narrowed blood vessel). At least one adjustable portion of the intravascular device 1200 may be configured to be positioned at a treatment site within a patient's body, such as during a procedure performed with the intravascular device. In some embodiments, the device movement mechanism of the control device 14400 may be connected to the shaft 4220 of the intravascular device 1200 and / or the core wire 4230 of the intravascular device 1200 and configured to move the shaft 4220 and / or the core wire 4230 to cause movement of the intravascular device 1200 (as described above).
[0106]
[0127] The control device 14400 may include at least one magnet 14420 operatively connected to the device movement mechanism. In some embodiments, the at least one magnet 14420 may include a single magnet or multiple magnets. In some embodiments, the magnet 14420 may be directly fixed to the device movement mechanism. Alternatively, the at least one magnet 14420 may be connected to the device movement mechanism via a gear mechanism. The at least one magnet 14420 may be configured to be actuated by a second magnet 14520 (described further below) of the user interface device 14500, thereby allowing the at least one magnet 14420 and the device movement mechanism to control the movement of the intravascular device 1200. For example, in response to a first actuation of the at least one magnet 14420, the device movement mechanism of the control device 14400 may be configured to cause an action by at least one adjustable portion of the intravascular device 1200 to transition the intravascular device to a first configuration at the treatment site. The action may include expanding or contracting the mesh segment 4210, bending or straightening a distal portion of an intravascular device (e.g., bendable segment 5202 in Figures 5A-5B or deflectable segment 6202 in Figure 6), or inflating or deflating a balloon device (not shown).
[0107]
[0128] In response to a second actuation of the at least one magnet 14420, the device movement mechanism causes a second action of at least one adjustable portion of intravascular device 1200 to transition the intravascular device to a second configuration at the treatment site, which may be configured differently from the first configuration. For example, control device 14400 may move intravascular device 1200 to a first configuration and a second configuration as steps of a procedure performed at the treatment site using intravascular device 1200. Examples of the second configuration may include expanding or contracting mesh segment 4210 or bending or straightening a distal portion of the intravascular device (e.g., bendable segment 5202 of FIGS. 5A-5B or deflectable segment 6202 of FIG. 6).
[0108]
[0129] The system 14000 may include a user interface device 14500 that a user may manipulate to control the action of the intravascular device 1200 at the treatment site. In some embodiments, the user interface device 14500 is a portable, reusable, handheld device. The user interface device 14500 may be placed in a sterile polyethylene bag (or similar aseptic pouch or peel pack) to maintain sterility throughout the intravascular procedure. The user interface device 14500 may include an input mechanism 14540 configured to receive input from a user. For example, the input mechanism 14540 may include a first input structure, such as at least one of a button, a keyboard, a computer mouse, a lever, a joystick, or a touch screen. The user interface device 14500 may also include at least a second magnet 14520 configured to actuate at least one magnet 14420 of the control device 14400 based on input received from the user via the input mechanism 14540. The at least one second magnet 14520 of the user interface device 14500 may include a single magnet or multiple magnets.
[0109]
[0130] In some embodiments, the user interface device 14500 may include an actuator 14530 configured to control the movement of the second magnet 14520. In some embodiments, the actuator 14530 may include a motor. Additionally or alternatively, the actuator 14530 may be connected to the second magnet 14520 by a mechanical connector, a gear mechanism, or any other suitable type of connection mechanism. The user interface device 14500 may also include at least one processor (not shown), which may be configured to cause the actuator 14530 to control movement of the second magnet 14520 based on at least one of user input received by the input mechanism 14540, data of at least one medical image taken during a procedure performed with the intravascular device (such as an image taken by the peripheral imaging device 1800 shown in FIG. 1 or by an additional imaging device), output from at least one sensor (such as output from the sensor 1600 shown in FIG. 1), or computer executable instructions stored in memory for treatment with the intravascular device 1200, etc. In some embodiments, the at least one sensor (e.g., the sensor 1600 in FIG. 1) may include a force meter configured to measure a force exerted by the control device 14400 or by a user to remove the intravascular device 1200 from a body structure. In such a case, the at least one processor of the user interface device 14500 may be configured to obtain a force measurement signal from the force meter and, based on the force measurement signal, control the movement of the second magnet 14520 by the actuator 14530 to actuate the at least one magnet 14420 of the control device. For example, the at least one processor may cause the actuation of the at least one magnet 14420 to reduce a magnitude of force exerted by the intravascular device 1200 on the body structure. Additionally or alternatively, the at least one processor of the user interface device 14500 may output an alert notification on the display mechanism 14510 to warn the user when a magnitude of force exerted during removal of the intravascular device 1200 is too large.
[0110]
[0131] In some embodiments, the at least one processor of the user interface device 14500 may be configured to obtain an input indicative of a desired movement of the intravascular device 1200 at the treatment site, determine at least one characteristic of a first force based on the input, and cause the actuator 14530 to exert a first force on the second magnet 14520 and actuate at least one magnet 14420 of the control device 14400 based on the determined at least one characteristic. In some embodiments, the exertion of the first force on the second magnet 14520 may cause a device movement mechanism of the control device 14400 (which may be connected to the at least one magnet 14420) to control at least one adjustable portion of the intravascular device 1200 to perform the desired movement at the treatment site. The at least one characteristic of the first force may include at least one of a magnitude of the first force, a duration of the first force, or a direction of the first force. In the embodiment of FIG. 14, at least one processor of the user interface device 14500 may be configured to obtain input indicating a desired movement of the intravascular device, determine at least one characteristic of a first force based on the input, and cause the actuator 14530 to apply a first force to the second magnet 14520 based on the determined at least one characteristic in a manner consistent with the above description of the embodiment shown in FIG. 1.
[0111]
[0132] In disclosed embodiments, the user interface device 14500 may include at least one output mechanism for outputting one or more notifications to a user. Examples of output mechanisms may include a visual display mechanism 14510 and an audio output mechanism. The user interface device 14500 may also include a power source (not shown).
[0112]
[0133] In some embodiments, the endovascular treatment system 14000 may be configured to control the action of an intravascular device having an adjustable (e.g., expandable) mesh, such as the expandable mesh 4210. In the disclosed embodiments, the device movement mechanism of the control device 14400 (which may be connected to at least one magnet 14420) may be connected to the core wire 4230 of the intravascular device 1200. The shaft 4220 may be connected to the control device 14400 or may be rigidly attached to the control device 14400. In some embodiments, in response to a first actuation of the at least one magnet 14420 of the control device 14400, the device movement mechanism of the control device 14400 may be configured to move the core wire in a first direction (e.g., a proximal direction). This movement of the core wire 4230 may cause the expandable mesh 4210 of the intravascular device 1200 to expand. Additionally or alternatively, in response to a second actuation of at least one magnet 14420 of the control device 14400, the device movement mechanism of the control device 14400 may be configured to move the core wire 4230 in a second direction (e.g., a distal direction), thereby contracting the mesh 4210.
[0113]
[0134] Additionally or alternatively, the device movement mechanism of the control device 14400 may be configured to move the core wire of the intravascular device 1200 to exert a pulsating force on the inner surface of the body structure at the treatment site in response to a third actuation of the at least one magnet 14420 of the control device 14400. The exertion of a pulsating force in the embodiment of FIG. 14 may be accomplished in a manner similar to the above description of the exertion of a pulsating force with respect to the embodiments of FIG. 3A, FIG. 3BB, and FIG. 8. Additionally or alternatively, the device movement mechanism of the control device 14400 may be configured to move the core wire 4230 in a second direction (e.g., distally) in response to a fourth actuation of the at least one magnet 14420 of the control device, thereby causing the mesh 4210 to retract. The device movement mechanism may also be configured to subsequently withdraw the intravascular device 1200 with the retracted mesh 4210 from the body structure and / or from the patient's body.
[0114]
[0135] In a disclosed embodiment, the control device 14400 may be configured to effect expansion and contraction of the mesh 4210 based on user input obtained via the input mechanism 14540 of the user interface device 14500. The obtained user input may specify at least one of a diameter of a body structure at a treatment site, a type of stenosis or occlusion to be treated with the intravascular device 1200 (e.g., thrombus, vasospasm, or plaque), a type of clot to be treated with the intravascular device 1200, a desired expanded diameter or shape of the expandable mesh 4210, instructions for expanding or contracting the mesh 4210 to a particular configuration, or a desired expansion and / or contraction time (e.g., a pulsating or massaging motion). The control device 14400 may be configured to control the movement of the expandable mesh 4210 to achieve the configuration of the intravascular device specified by the user input.
[0115]
[0136] In some embodiments, the endovascular treatment system 14000 may be configured to control the action of an endovascular device that is a guidewire (e.g., endovascular device 1200b of FIGS. 5A-5B). The control device 14400 may be configured to control the bending and / or straightening of at least one distal portion 5202 of the guidewire device by manipulating a core wire of the guidewire device (not shown). The core wire may be configured as a control wire. The distal portion may include a distal tip.
[0116]
[0137] In response to a first actuation of the at least one magnet 14420 of the control device 14400, the device movement mechanism may be configured to move a core wire (e.g., a control wire) of the guidewire device in a first direction (e.g., a proximal direction) while keeping the elongated shaft 5220 of the guidewire device stationary, thereby bending the bendable distal portion 5202 of the guidewire device from a straightened configuration to a first bent configuration. In response to a second actuation of the at least one magnet 14420 of the control device 14400, the device movement mechanism may be configured to move a core wire of the guidewire device in a second direction (e.g., a distal direction) opposite the first direction, while keeping the elongated shaft 5220 of the guidewire device stationary, thereby bending the distal portion 5202 of the guidewire device from the first bent configuration to one of the straightened configuration or the second bent configuration.
[0117]
[0138] 15A-15C show isometric, plan, and front views, respectively, of a cross section of a magnet according to some embodiments of a device movement mechanism of an endovascular treatment system 14000. A magnetic movement housing 15430 may house a first at least one magnet 14420. The first at least one magnet 14420 may be operatively connected to the device movement mechanism as shown in FIG. 14. The first at least one magnet 14420 may be configured to be actuated by a second at least one magnet 14520 of a user interface device 14500 as shown in FIG. 14. The second at least one magnet 14520 may be included within a movement cart 15532. The movement cart 15532 may be connected to an actuator 14530 of the user interface device 14500 shown in FIG. 14. In response to a first actuation of the first at least one magnet 14420, the device movement mechanism of the control device 14400 may be configured to cause an action by at least one adjustable portion of the intravascular device 1200, as described above with reference to Figure 14. Additionally or alternatively, the device movement mechanism of the control device 14400 may be configured to cause movement (e.g., distally or proximally) of the intravascular device 1200, as described above.
[0118]
[0139] The first at least one magnet 14420 and the second at least one magnet 14520 may form multiple sets of magnets. For example, as shown in the embodiment depicted in Figures 15A-15B, the first at least one magnet 14420 and the second at least one magnet 14520 may form four sets of magnets. It is contemplated that the first at least one magnet 14420 and the second at least one magnet 14520 may form any number of sets of magnets, such as, but not limited to, two, three, four, five, six, seven, eight, nine, ten, or more magnets.
[0119]
[0140] 15B, which shows a plan view of a cross section of the device movement mechanism, the first at least one magnet 14420 and the second at least one magnet 14520 may be arranged such that opposite poles (N for north and S for south) face each other for each set of magnets. In some embodiments, ferromagnetic material 15534 may be placed on the outer edge of the second at least one magnet 14520 to close the magnetic field lines and / or prevent the generation of undesired magnetic forces.
[0120]
[0141] 15C, the magnetic transfer housing 15430 may be disposed in a control device body 14410 of the control device 14400. The control device body 14410 may be connected to a core wire (not shown) of an intravascular device. In some embodiments, the control device body 14410 may be connected to other types of intravascular devices. In some embodiments, a sterile bag 15502 may partially or completely encapsulate the user interface device 14500, separating the non-sterile user interface device 14500 from the sterile intravascular device (not shown) and the sterile control device body 14410.
[0121]
[0142] 16 illustrates one embodiment of a device movement mechanism 2412e of an endovascular treatment system 14000 consistent with disclosed embodiments. The device movement mechanism 2412e may be configured similarly to the device movement mechanism 2412a of FIG. 10 and / or the device movement mechanism 2412c of FIG. 12. The device movement mechanism 2412e may include a motor 16010, a gear box 16020, a screw gear 16030, a screw gear load 16040, and an encoder 16050. The device movement mechanism 2412e may also include a magnetic movement housing 15430 and a movement cart 15532. The magnetic movement housing 15430 may include a first at least one magnet 14420. The movement cart 15532 may include a second at least one magnet 14520. The first at least one magnet 14420 may be configured to be actuated by the second at least one magnet 14520 of the user interface device 14500, as described above. In some embodiments, the first at least one magnet 14420 may be connected to the core wire 10230. Longitudinal movement of the screw gear load 10040 may result in movement of the first at least one magnet 14520 and the magnetic movement housing 15430, which in turn may move the core wire 10230 relative to the shaft 10220 of the intravascular device 1200 (e.g., the elongated shaft 4220 of FIGS. 4A-4D, the elongated shaft 5220 of FIGS. 5A-5B, or the elongated sheath 6220 of FIG. 6). The shaft 10220 may be rigidly attached to the control device 14410 or a portion thereof, thus allowing movement of the core wire 10230 to be translated into performance of a desired action of the intravascular device 1200. According to one embodiment, the magnetic movement housing 15430 can also be connected to the intravascular device shaft 10220 via a rigid connector 10230 that can move the intravascular device shaft 10220 in response to corresponding movement of the first at least one magnet 14520 and the magnetic movement housing 15430.
[0122]
[0143] 17 illustrates one embodiment of a device movement mechanism 2412f of an endovascular treatment system 14000 consistent with disclosed embodiments. The device movement mechanism 2412f may be configured similarly to the device movement mechanism 2412b of FIG. 11 and / or the device movement mechanism 2412d of FIG. 13. The device movement mechanism 2412f may include a motor 17010, a gear box 17020, a belt 17060, a pulley 17070, and an encoder 17050. The device movement mechanism 2412f may also include a magnetic movement housing 15430 and a movement cart 15532. The magnetic movement housing 15430 may include a first at least one magnet 14420. The movement cart 15532 may include a second at least one magnet 14520. The first at least one magnet 14420 may be configured to be actuated by the second at least one magnet 14520 of the user interface device 14500, as described above.
[0123]
[0144] The above description has been presented for purposes of illustration. It is not exhaustive or limited to the precise forms or embodiments disclosed. Modifications and adaptations of the embodiments will be apparent from consideration of the specification and practice of the disclosed embodiments. While certain components are described as being coupled to each other, such components may be integrated with each other or distributed in any suitable manner.
[0124]
[0145] Moreover, although exemplary embodiments are described herein, the scope includes any embodiment having equivalent elements, modifications, omissions, combinations (e.g., aspects across various embodiments), adaptations and / or alterations based on the present disclosure. The elements of the claims should be interpreted broadly based on the language used in the claims and should not be limited to the examples described in the specification or during the prosecution of this application, which examples should be interpreted as non-exclusive. Furthermore, the steps of the disclosed methods can be modified in any manner, including changing the order of steps and / or inserting or deleting steps.
[0125]
[0146] The features and advantages of the present disclosure are apparent from the detailed specification, and it is therefore intended that the appended claims encompass all systems and methods that fall within the true spirit and scope of the present disclosure. As used herein, the indefinite articles "a" and "an" mean "one or more." Similarly, the use of a plural term does not necessarily indicate a plurality, unless otherwise clear in a given context. Words such as "and" or "or" mean "and / or" unless otherwise indicated. Furthermore, since numerous modifications and variations will readily occur from the study of this disclosure, it is not desired to limit the disclosure to the exact construction and operation shown and described, and therefore, all suitable modifications and equivalents within the scope of the present disclosure may be used.
[0126]
[0147] Throughout this application, various embodiments of the present disclosure may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the present disclosure. Thus, the description of a range should be considered to specifically disclose all possible subranges and individual numerical values within that range. For example, the description of a range such as 1-6 should be considered to include subranges such as 1-3, 1-4, 1-5, 2-4, 2-6, 3-6, etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This is true regardless of the breadth of the range.
[0127]
[0148] Other embodiments will be apparent from consideration of the specification and practice of the embodiments disclosed herein. It is intended that the specification and examples be considered as exemplary only, with an actual scope and spirit of the disclosed embodiments being indicated by the following claims.
Claims
1. 1. A system for digital control of an intravascular device, comprising: At least one processor, obtaining an input indicative of a first desired action of the intravascular device within the patient's anatomy; determining at least one characteristic of a first force based on the input; causing a control device of the intravascular device to apply the first force to a first portion of the intravascular device based on the determined at least one characteristic, the first portion of the intravascular device being disposed outside the patient's body, and application of the first force causing a second portion of the intravascular device to perform the first desired action within the body structure. At least one processor configured to Including, the system.
2. The input is: input from a user performing a procedure using the intravascular device; a first set of at least one medical image taken before or during a procedure performed with the intravascular device; or Second data obtained from the at least one sensor output. The system of claim 1 , comprising at least one of:
3. The input from the user includes: a control handle operatively connected to the at least one processor; Device including at least a second processor The system of claim 2 , wherein the information is obtained from at least one of:
4. A control device for controlling movement of an intravascular device, the control device being configured to be positioned outside a patient's body, the control device comprising: an input mechanism configured to receive input from a user; a device movement mechanism configured to control at least one movable part of the intravascular device, the movable part of the intravascular device configured to be positioned inside the patient's body; and At least one processor, at least one processor configured to actuate the device movement mechanism in response to a first input to move the at least one moveable part of the intravascular device to move the intravascular device to a first configuration; a control device.
5. The at least one processor The control device of claim 4, configured to actuate the device movement mechanism in response to a second input to move the at least one movable part of the intravascular device to move the intravascular device to a second configuration different from the first configuration.
6. The at least one processor moving a first movable part and a second movable part of the intravascular device in the same direction; moving the first movable part of the intravascular device in a first direction and moving the second movable part of the intravascular device in a second direction opposite the first direction; or moving at least one movable part of the intravascular device while another part of the intravascular device remains stationary relative to the control device. The control device according to claim 4 or 5, configured to actuate the device movement mechanism to do at least one of the following:
7. The control device of claim 5 , wherein at least one of the first input or the second input is a user input received via the input mechanism.
8. The intravascular device includes an expandable mesh and a core wire secured to a distal end of the expandable mesh; The control device is configured to actuate the core wire to cause expansion and / or contraction of the expandable mesh. A control device according to claim 4 or 5.
9. The at least one processor activating the device movement mechanism in response to the first input to move the core wire of the intravascular device in a first direction, thereby expanding the mesh; and / or In response to a second input, actuating the device movement mechanism to move the core wire in a second direction opposite to the first direction, thereby contracting the mesh. The control device according to claim 8, configured to:
10. 1. An endovascular treatment system, comprising: an intravascular device configured for controllable movement at a treatment site within a patient's body, the intravascular device including at least one moveable part; A control device for controlling the intravascular device, the control device comprising: an input mechanism configured to receive input from a user; a device movement mechanism configured to control the at least one movable part of the intravascular device; At least one processor, at least one processor configured to actuate the device movement mechanism in response to a first input to move the at least one moveable part of the intravascular device to move the intravascular device to a first configuration at the treatment site; A control device including:
1. An endovascular treatment system comprising:
11. The at least one processor activating the device movement mechanism in response to a second input to move the at least one moveable portion of the intravascular device to move the intravascular device to a second configuration at the treatment site, the second configuration being different from the first configuration. The endovascular treatment system of claim 10 , configured as follows.
12. 12. The endovascular treatment system of claim 10 or 11, wherein the at least one processor of the control device is configured to adjust a ratio between a displacement of a first movable part of the intravascular device by the device movement mechanism and a corresponding displacement of a second movable part of the intravascular device by the device movement mechanism.
13. 12. The endovascular treatment system of claim 11, wherein the input mechanism includes at least a first input structure for receiving the first input from the user and a second input structure for receiving the second input from the user, each of the first input structure and the second input structure including at least one of a button, a keyboard, a computer mouse, a lever, a joystick, or a touch screen.
14. The intravascular device includes an expandable mesh and a core wire secured to a distal end of the expandable mesh; The control device is configured to actuate the core wire to cause expansion and contraction of the expandable mesh. The intravascular treatment system according to claim 10 or 11.
15. The at least one processor of the control device activating the device movement mechanism in response to the first input to move the core wire of the intravascular device in a first direction, thereby expanding the mesh; and / or In response to a second input, actuating the device movement mechanism to move the core wire in a second direction, thereby contracting the mesh. The endovascular treatment system of claim 14 , configured as follows: