Mechanical actuation of a catheter

Through the electronically controlled actuator system and catheter system, the complexity and difficulty of fine adjustment of the catheter system during delivery and deployment of heart valve prosthesis are solved, and the safe and precise deployment of the prosthesis is achieved, reducing surgical trauma and risks.

CN119816263APending Publication Date: 2025-04-11EDWARDS LIFESCIENCES CORP
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Patent Information

Application Number
CN202380063329.X
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Priority Date
2022-08-04
Filing Date
2023-08-02
Publication Date
2025-04-11

AI Technical Summary

Technical Problem

The prior art faces challenges in delivering and deploying heart valve prostheses, including the complexity of the catheter system, the difficulty of fine adjustment of catheter controls, and the inadequate ability to fix damage-free fixation of tissues in the lumen.

Method used

An electronically controlled actuator system and catheter system, including frame, bracket and bracket drive system, enables precise control and movement of the catheter system through multiple lumens and adapters. The system uses weighing sensors and control signals to adjust the positioning of the bracket to actuate the lumen of the catheter system.

Benefits of technology

The surgical process is simplified, the clinician's precise control ability is improved, and the prosthesis can be deployed safely and accurately to the desired location, reducing trauma and risk to patients.

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Abstract

A medical system includes an electronically controlled actuator system and a catheter system for providing access within a body lumen. The electronically controlled actuator system includes: a plurality of brackets mounted with a frame and movable relative to the frame along a longitudinal axis; and a carriage drive system configured to adjust a positioning of each of the carriages. The catheter system includes a distal end, a proximal end, a plurality of lumens extending between the distal end and the proximal end, and a plurality of adapters. Each of the adapters may be coupled to a corresponding bracket and attached to a lumen such that adjusting the positioning of the corresponding bracket actuates the attached lumen. The actuator system has a control system with executable instructions to control the plurality of carriages and thus the lumen of the catheter system.
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Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 395,159, filed on August 4, 2022, the entire contents of which are hereby incorporated by reference herein. Technical Field

[0003] Embodiments disclosed herein generally relate to catheter systems for delivering prostheses and control systems therefor. Background Art

[0004] The human heart valves, including the aortic, pulmonary, mitral, and tricuspid valves, function like one-way valves that operate in sync with the pumping heart. The valves allow blood to flow downstream but prevent blood from flowing upstream. Diseased heart valves exhibit damage, such as valve narrowing or regurgitation, which inhibits the valve's ability to control blood flow. Such damage reduces the heart's efficiency in pumping blood and can lead to debilitating and life-threatening conditions. For example, valvular insufficiency can lead to conditions such as cardiac hypertrophy and ventricular dilatation. Therefore, a great deal of effort has been made to develop methods and devices for repairing or replacing damaged heart valves.

[0005] The existence of prosthesis is to correct the problems associated with damaged heart valves. For example, mechanical and tissue-based heart valve prostheses can be used to replace damaged natural heart valves. Recently, a lot of efforts have been devoted to the development of replacement heart valves, particularly tissue-based replacement heart valves, which can be delivered with less trauma to the patient than by open heart surgery. Replacement valves are designed to be delivered by minimally invasive surgery and even non-invasive percutaneous surgery. Such replacement valves generally include a tissue-based valve body, which is connected to an expandable frame, and then the expandable frame is delivered to the annulus of the native valve.

[0006] The development of prostheses, including but not limited to replacement heart valves, that can be compressed for delivery and then controllably expanded for precise implantation has proven challenging. Additional challenges relate to the ability of such prostheses to be atraumatically secured relative to intraluminal tissue, such as tissue within any body lumen or cavity.

[0007] It is also challenging to deliver a prosthesis to a desired location in the human body, such as delivering a replacement heart valve to the mitral valve. Obtaining access for surgery at the heart or other anatomical locations may require passing through a tortuous vasculature or through an open or semi-open surgical percutaneous delivery device. Catheter-based implantation of a prosthesis can be particularly challenging when the clinician manipulates many catheter shafts and actuation mechanisms during surgery. Therefore, there is a need to simplify the procedure and improve the clinician's ability to precisely control the movement of the catheter through the vasculature and deploy the prosthesis at the desired location. Summary of the invention

[0008] A medical system comprising an electronically controlled actuator system and a catheter system for providing a passage in a body cavity. The electronically controlled actuator system may include: a frame extending along a longitudinal axis; a plurality of brackets mounted with the frame and movable relative to the frame along the longitudinal axis; and a bracket drive system configured to adjust the positioning of each of the brackets along the longitudinal axis based on at least one control signal. Each of the plurality of brackets may include a nest coupled thereto, the nest configured to rotate about the longitudinal axis. The catheter system may include a distal end, a proximal end, a plurality of lumens, and a plurality of adapters, the plurality of lumens extending between the distal end and the proximal end. Each of the adapters may be attached to the plurality of lumens. Preferably, each of the plurality of adapters is coupled to a corresponding bracket of the plurality of brackets such that adjusting the positioning of the corresponding bracket along the longitudinal axis actuates the attached lumen.

[0009] According to another aspect, the actuator system has a control system having at least one computer-readable memory having executable instructions stored thereon; and one or more processors communicating with the at least one computer-readable memory to execute the instructions so that the system at least: receives an input signal and generates the at least one control signal based on the input signal. According to another aspect, the actuator system has a user interface for providing the input signal. According to another aspect, the user interface is located remote from the actuator system and is in wired or wireless communication with the control system. According to another aspect, the multiple lumens of the catheter system include an outer sheath assembly, an intermediate shaft assembly, a track assembly, and an inner shaft assembly.

[0010] According to another aspect, a first load cell measures a force applied by a first bracket of the plurality of brackets to a first lumen of the plurality of lumens. According to another aspect, a first load cell is mounted on the first bracket and contacts the first adapter when a first adapter of the plurality of adapters is coupled to the first load cell. According to another aspect, a user interface displays the force measured by the first load cell relative to an allowable force limit associated with the first lumen. According to another aspect, a user interface displays an available range of motion of the first lumen based on the force measured by the first load cell and the allowable force limit. According to another aspect, execution of the instructions further causes the system to: receive a force signal from the first load cell; and further generate the at least one control signal based on a comparison of the force signal with the allowable force limit. The at least one force signal prevents exceeding one or more allowable force limits.

[0011] According to another aspect, the at least one control signal adjusts the positioning of at least two of the plurality of brackets along the longitudinal axis into a first group. According to another aspect, each of the plurality of brackets includes a receiving slot configured to receive one of the plurality of adapters therein. According to another aspect, each of the adapters includes one or more lateral projections extending perpendicular to the longitudinal axis of the frame, and each of the receiving slots includes one or more upward projections configured to engage with the one or more lateral projections. According to another aspect, the proximal end of the catheter system includes a handle housing including one or more housing members. According to another aspect, wherein the plurality of adapters protrude laterally outward from within the handle housing. According to another aspect, the handle housing is removable. According to another aspect, the frame is rotatable on an axis of rotation that is parallel or substantially aligned along the longitudinal axis. According to another aspect, a first pivot mount is connected to a first end of the frame, and a second pivot mount is connected to a second end of the frame, the first pivot mount and the second pivot mount being aligned along the axis of rotation. According to another aspect, the plurality of lumens are attached to the plurality of adapters via respective guidewires. According to another aspect, the base or table includes an upper surface supporting the frame. According to another aspect, a hospital bed supports the base or table.

[0012] According to another aspect, the frame includes a pair of tracks extending parallel to the longitudinal axis, and the plurality of carriages are mounted on the pair of tracks. According to another aspect, the carriage drive system includes a motor for each of the plurality of carriages. According to another aspect, the carriage drive system includes a rack attached to the frame, and each of the motors includes a pinion meshing with the rack. According to another aspect, each of the plurality of carriages includes a limit switch or proximity switch for homing the carriage relative to the frame. According to another aspect, the catheter system can be any catheter system from a group of catheter systems including a plurality of universal adapters. According to another aspect, the plurality of carriages can be repositioned to receive any catheter system from the group of catheter systems in an initial preprogrammed interval configuration. According to another aspect, the at least one control signal is further based on an autonomous or semi-autonomous control algorithm.

[0013] On the other hand, a method includes positioning an electronically controlled actuator system relative to a patient. The electronically controlled actuator system has a frame extending along a longitudinal axis, a bracket mounted with the frame movable relative to the frame along the longitudinal axis, and a bracket drive system adjusting the positioning of the bracket along the longitudinal axis. The method includes making an incision to access the vascular system of the patient. The method includes inserting the distal end of a catheter system into the vascular system of the patient through the incision, and advancing the distal end through the vascular system into an anatomical region of the patient or adjacent to the anatomical region. The method includes aligning the proximal end of the catheter system relative to the electronically controlled actuator system. The method includes coupling an adapter of the catheter system to the bracket. The method includes receiving at least one control signal at a control system of the electronically controlled actuator system. The method includes adjusting the positioning of the bracket along the longitudinal axis based on at least one control signal, and thereby actuating the lumen of the catheter system.

[0014] According to another aspect, the input signal is from a user interface, and the at least one control signal is generated based on the input signal. According to another aspect, the method includes receiving a force signal from a load cell and further generating the at least one control signal based on the force signal. According to another aspect, the method includes calculating an available range of motion of the lumen based on the force signal measured by the first load cell and an allowed force limit of the lumen. According to another aspect, the method includes adjusting the positioning of the bracket to an initial preprogrammed position before coupling the adapter of the catheter system to the bracket. According to another aspect, the catheter system includes a plurality of lumens and a plurality of corresponding adapters, and the electronically controlled actuator system includes a plurality of brackets.

[0015] The foregoing summary of the invention is illustrative only and is not intended to be limiting. Other aspects, features and advantages of the systems, devices and methods and / or other subjects described in this application will become apparent in the teachings set forth below. This summary is provided to introduce a selection of some of the concepts of the present disclosure. This summary is not intended to identify the key or essential features of any subject matter described herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Various examples are depicted in the drawings for purposes of illustration, and these examples should not be construed as limiting the scope of the examples. Various features of different disclosed examples can be combined to form further examples, which are part of the present disclosure.

[0017] Figure 1 An electronically controlled actuator including a plurality of movable carriages for use with a catheter system is schematically illustrated;

[0018] Figure 2 Shown Figure 1 a perspective view of an electronically controlled actuator as shown;

[0019] Figure 3 A partial perspective view of another electronically controlled actuator is shown;

[0020] Figure 4-5 A partial perspective view of another electronically controlled actuator is shown;

[0021] Figure 6 An adapter for connecting a lumen of a catheter system to a bracket of an electronically controlled actuator is shown;

[0022] Figure 7-8 A partial perspective view of another electronically controlled actuator is shown;

[0023] Fig. 9 Another electronically controlled actuator was shown;

[0024] Figure 10-11 An embodiment of using two motors to move the lumen translationally and rotationally, respectively, is schematically shown;

[0025] Fig.12 Another embodiment of using two motors to move the lumen translationally and rotationally, respectively, is schematically shown;

[0026] Fig.13 An embodiment of converting a translational movement into a rotational movement is schematically shown;

[0027] Fig.14 An embodiment of using a motor to move the lumen both translationally and rotationally is schematically illustrated;

[0028] Fig.15 A control method for electronically controlled actuators. DETAILED DESCRIPTION

[0029] Various features and advantages of the systems, devices, and methods of the technology described herein will become more fully apparent from the following description of the examples shown in the accompanying drawings. These examples are intended to illustrate the principles of the present disclosure, and the present disclosure should not be limited to the illustrated examples. In view of the principles disclosed herein, it will be apparent to those of ordinary skill in the art that the features of the illustrated examples may be modified, combined, removed, and / or replaced.

[0030] Transcatheter repair and native anatomy replacement procedures may require the use of complex catheter systems, the flexibility to fine-tune catheter controls, and expert interpretation of fluoroscopy and / or echo imaging modalities to appropriately treat the patient. As the need for additional functionality focuses on catheter technology, new failure modes may emerge. Mechanized systems are steadier than the human hand and can make more precise and repeatable movements. Imaging software is currently being developed to better represent the interaction between the catheter and the patient's anatomy using various imaging modalities. With these three points in mind, a system that can actuate the catheter system will make the procedure safer, more repeatable, and more precise.

[0031] Figure 1 A medical system comprising an electronically controlled actuator 100 and a catheter system 200 for a patient 1 resting on a patient support 5 is shown. The electronically controlled actuator or system 100 may include a frame 110. The frame 110 may extend along a longitudinal axis 101. The frame 110 may be supported by a base 105. The base 105 may rest on a floor, on a patient support 5, or on another structure. The base 105 may be moved and / or fixed in position relative to the patient support 5. The base 105 may position the frame 110 relative to the patient 1 for proper positioning of the catheter system 200.

[0032] The frame 110 can support a plurality of brackets 120 mounted with the frame 110. The brackets 120 can move relative to the frame. For example, the brackets 120 can move along the frame 110 (e.g., the longitudinal axis 101). The brackets 120 can be aligned along the longitudinal axis 101. Each of the brackets 120 can include a groove or other coupling feature configured to retain a lumen of a catheter. Each of the brackets can include a load cell for measuring a force associated with each bracket (e.g., applied to each bracket).

[0033] The carriage drive system 130 may include actuators, motors, and / or other mechanisms to control the positioning of each of the carriages 120 within the frame 110. Each of the carriages 120 may move independently or in subgroups (e.g., pairs) relative to any other carriage of the drive system 130. The drive system 130 may include positioning sensors for tracking the carriages 120 along the frame 110 (e.g., along the longitudinal axis 101). The drive system 130 may include limit switches and / or proximity switches for homing the carriages 120 at appropriate locations along the frame 110 (e.g., along the longitudinal axis 101) and / or relative to other carriages.

[0034] The carriage drive system 130 may include a control system for adjusting the positioning of the carriage 120. The control system may include at least one computer readable memory and one or more processors, the at least one computer readable memory having executable instructions stored thereon, and the one or more processors communicate with the at least one computer readable memory to execute the instructions. The executed instructions may receive an input signal and generate at least one control signal based on the input signal. The input signal may include a set of instructions for adjusting the positioning of one or more carriages in the carriage 120. The input signal may be manually sent, such as through a user interface 140 including one or more controls, or generated by an autonomous or semi-autonomous control algorithm. The user interface 140 may be a local (e.g., on the base 105) interface or away from the frame 110. The user interface 140 may be wired or wirelessly communicated with the control system.

[0035] The catheter system 200 can provide access for one or more instruments to approach a working site in a body cavity. Various types of catheter systems 200 are contemplated herein. In one example, the catheter system 200 includes a deployable replacement heart valve, such as a delivery system described in U.S. Patent Publication No. 2019 / 0008640, the entire contents of which are hereby incorporated by reference. The catheter system 200 may include a distal end (not shown) of a distal end 201 and a proximal end 202 that can be attached to a handle. The distal end can be inserted into the vascular system of the patient 1 to approach a remote working site such as the patient's heart through a transfemoral approach.

[0036] The catheter system 200 may include multiple lumens 250 extending between the distal end and the proximal end. The term "lumen" herein may refer to an axis or a tube or other physical structure with a lumen therein. The lumen 250 may be encapsulated or nested together, which means that a smaller lumen may be encapsulated in a larger lumen, wherein all lumens have approximately the same length. In this way, the multiple lumens 250 may be encapsulated or nested together as an assembly, thereby allowing the lumen to move longitudinally relative to other lumens. When each lumen in the lumen 250 is held by a bracket in the bracket 120 of the system 100, each lumen in the lumen 250 may be independently longitudinally translated. The lumen 250 may include an outer sheath assembly, an intermediate shaft assembly, a track assembly, and an inner shaft assembly. The lumen 250 may be actuated to deploy the prosthesis at the work site. The proximal end 202 of the catheter system 200 may include one or more control features of a handle and / or lumen 250. The proximal end 202 of the catheter system 200 may include a handle housing including one or more housing members. The housing member may completely or partially enclose the control feature. The housing member may be completely or partially removable to access the control feature. The control feature may include a plurality of adapters 260. Each of the adapters 260 may be attached to a lumen of a plurality of lumens 250 such as by a guidewire. The adapter 260 may be coupled to a corresponding one of the brackets 120. In one example, the adapter 260 may be accommodated in a groove in the corresponding bracket 120. In another example, the bracket 120 may include a clamp, a protrusion or other coupling mechanism that engages (e.g., is inserted into) the corresponding adapter. Therefore, adjusting the positioning of the bracket 120 along the frame 110 (e.g., along the axis 101) actuates the attached lumen 250.

[0037] In certain embodiments, an operator can interact with the system 100 to control the catheter system 200 via the user interface 140. The user interface 140 can include a selection interface for selecting (e.g., individually or as a subset) one or more lumens 250. The user interface 140 can include controls for adjusting the positioning of the selected one or more lumens 250 (e.g., controlled adjustment or manual adjustment).

[0038] The carriage drive system 130 can move the carriage 120 into one or more preprogrammed configurations. The preprogrammed configurations can correspond to the initial and / or other operable positioning of one or more control features of the catheter system 200. The initial configuration can be used to accommodate a variety of different catheter system designs or different medical procedures, which can use different initial intervals for the adapter 260. The carriage drive system 130 can move the carriage 120 to the appropriate position based on input from the operator at the user interface 140. The user interface 140 can include a selection menu of various preprogrammed configurations of the system 100. The selection can be based on the type of catheter system and / or medical procedure.

[0039] The system 100 may include automated controls for performing one or more steps of a medical procedure using the catheter system 200. The steps of the medical procedure and the required movement of the carriage 120 and the corresponding lumen 250 may be preprogrammed into the system 100. The user interface 140 may include selections corresponding to each step of the medical procedure. The operator may perform the steps of the medical procedure based on the selection of an appropriate program (e.g., step). The selection of a step (e.g., execution) may automatically move the carriage 120 according to a preprogrammed movement and / or position. For some catheter systems, releasing tension or compression on a first lumen to perform a first movement and then continuing to apply tension or compression of a second lumen to perform a second movement may be critical to preventing failure in the catheter system. Therefore, the system 100 may automatically offset or reverse drive the lumen during or between the steps of the medical procedure.

[0040] The automated procedural steps performed by the system 100 and the catheter system 200 can be based on the detected positioning of the catheter system 200. The imaging mode can be used to provide images of the anatomical structure and the catheter system 200 related to success during medical surgery. The advancement of imaging modes continues to improve the resolution of such images. When the catheter system 200 is in the appropriate positioning for performing procedural steps or when the catheter system 200 is not in the appropriate positioning for performing procedural steps, software (including machine learning techniques) can be used to interpret these images and identify them with high confidence. This determination can be linked to the system 100 and / or provided to the operator. Therefore, the operator or the system 100 has the opportunity to manually adjust the catheter system 200 or approve automatic adjustment. When performed by the system 100, the process can provide a high level of precision and speed to the surgery. Ideally, the system 100 can be completely autonomous or allow the operator to accept the recommended procedural movement.

[0041] The system 100 can measure a force feedback signal. The force feedback signal can be generated by a sensor (such as a load cell mounted on the carriage 120) based on the current of the motor of the carriage drive system 130 and / or other devices. The carriage drive system 130 can move the carriage 120 in a manner to prevent exceeding one or more force thresholds of the system (e.g., the threshold of each specific lumen) based on the force feedback signal. Optionally, the user interface 140 can include a warning that the system has prevented / exceeded any such threshold. Optionally, the user interface 140 can provide a manual override of one or more safety thresholds. In one example, the load cell measures the force applied by the carriage of the plurality of carriages 120 to the lumen of the plurality of lumens 150. The load cell can be mounted on the first carriage and contact the adapter when the adapter in the plurality of adapters 260 is coupled to the carriage. The user interface 140 can display the force measured by the load cell and / or compare the force to the allowable force limit associated with the lumen. The user interface 140 can display the available range of motion of the lumen based on the force measured by the load cell and the allowable force limit. Optionally, based on operator input, the allowed force limit may be exceeded. Being able to measure forces in real time, move multiple lumens at a time, and fully understand the position of each lumen relative to another lumen can advantageously allow additional features that are difficult to achieve using traditional handle designs. For example, these features can be used to mitigate safety risks and procedural manipulations.

[0042] The carriage drive system 130 can move the carriage 120 based on the limit of the translation rate for any lumen / carriage. Each lumen can have a target movement rate or rate range (higher rate and lower rate). The target movement rate can change according to the steps of the medical operation being performed. The translation rate and / or force threshold can be based on the failure test of the catheter system. The translation rate and / or force threshold can be set to overcome any internal friction of the catheter system without overshooting the desired position. Force feedback signals can be used to detect irregularities (such as incomplete manipulation) or faults (such as adhesion of the lumen) in the catheter system during any step of the medical operation. Based on models and / or tests, the range of forces required to move any carriage of a given configuration of the catheter system can be known. Therefore, deviations from the expected range can be automatically identified. Warnings can be provided to the operator through the user interface.

[0043] Fluid pressure sensors may also be implemented in electronically controlled actuator systems to provide information to an operator or control system during a procedure. Connecting tubing to a flush port, which may be ubiquitous on a catheter, would allow access to the pressure directly surrounding the catheter in the body. An example use case may be for heart valve replacement. Manipulation of fixed valve leaflets may result in a pressure drop that is harmful to the patient. The fluid pressure sensor may provide feedback in a time-sensitive manner to the operator or automatically to a motor to reverse or stop catheter movement.

[0044] Figure 2 Additional details of the system 100 are shown. The system 100 may include a frame 110 supported by a base 105. The base 105 may include a lower support 106. The lower support 106 may be configured to rest on a bed or on a floor. The base 105 may include an upper support 107 extending vertically upward from the lower support 106. A joint 144 or a pivot mechanism or other rotation mechanism may be disposed between the lower support 106 and the upper support 107. The joint 144 may be a universal joint or the like, allowing the upper support 107 to rotate, pivot or bend in a direction 146 so that the catheter system 200 can be tilted up and down. The joint 144 may also allow the upper support 107 to rotate in a direction 148 so that the catheter system 200 can be moved laterally. Thus, the distal end of the catheter system 200 can be moved to accurately aim at the working site in the body cavity (e.g., to accommodate the angle of the patient) to perform medical treatment or diagnostic procedures (e.g., the above-mentioned medical surgery) without moving the base 105. After adjustment, the joint 144 can be locked by a locking mechanism so that the catheter system 200 does not move accidentally during surgery. The upper support 107 may include a first pivot control 108 and a second pivot control 109. The pivot controls 108, 109 may be pivotally coupled to the frame 110. The pivot controls 108, 109 may be aligned along the longitudinal axis 101. The pivot controls 108, 109 rotate along the direction 152 to allow the frame 110 to rotate around the longitudinal axis 101 to control the rotational positioning of the catheter system 200 during medical surgery. The upper support 107 may include a mounting position for the user interface 140 (or a portion thereof). The user interface 140 may include a display screen 141 and / or an input / control device 142.

[0045] The frame 110 may include a cover 111. The cover 111 may close a cavity containing the bracket 120. The bracket 120 may include a plurality of brackets, such as Figure 2 As described above, one or more of the brackets 120 may include a motor controller, such as the first to seventh motor controllers 131a-137a. The motor controllers 131a-137a may be mounted on the brackets 121-127, respectively, and are operable to move the brackets along the longitudinal axis 101. As described above, one or more of the brackets 120 may include a load cell. The load cell may be mounted on the brackets 121-127, respectively, and is operable to measure the force applied by the brackets to the catheter system 200.

[0046] Figure 3A partial perspective view of an electronically controlled actuator or system 100a as one embodiment of system 100 is shown. System 100a may include a frame 310. A front wall of frame 310 may include a cutout 310a that receives a portion of catheter system 200 when assembled with the catheter system. System 100a may include a bracket 320. Bracket 320 (e.g., Figure 1 The illustrated bracket 120) can be moved along the frame 310. The bracket 320 can include a plurality of brackets, such as first to eighth brackets 321-328. Figure 3 As can be seen in the figure, the outer tip of the bracket (e.g., 321, 322, 323, 326, 327, 328) can be shaped (e.g., U-shaped) and configured to be nested in an adjacent bracket. Each bracket 320 may include a slot for accommodating an adapter of the catheter system 200. For example, the first bracket 321 has a slot defined between the side walls 321a, 321b to accept the adapter. Each bracket 320 may include a motor of a bracket drive system, such as the first to eighth motors 331-338. Each motor may include a pinion (e.g., gear 331a) that can mesh with a rack 330 extending along the frame 310 in the moving direction. The bracket 320 can be moved along the rack 330 by actuation of the motor. One or more of the brackets 320 may include a limit switch or proximity switch 331b for homing the bracket relative to the frame and / or other brackets. Each bracket 320 may include one or more mounting members for fixing a port (e.g., a flushing port). Alternatively or in addition to providing linear movement, one or more brackets that provide different types of movement can be included. In one example, the bracket can include a rotary drive, as will be further described later. The rotary drive can be used to deploy and / or retract an elongated member, such as a suture or tether.

[0047] Figure 4-5 A partial perspective view of an electronically controlled actuator 100b is shown as another embodiment of the system 100. The system 100b may include a frame 410 including a first side rail 411 and a second side rail 412. A carriage 420 may be mounted on the rails 411, 412 by slots 421, 422, respectively, and may be movable along the rails. A motor 431 may be coupled to the carriage 420. The motor 431 may engage with the rack 430 by a pinion 431a in the manner described above with respect to the system 100a.

[0048] Figure 6 Shown with reference Figure 1 Adapter 560 is an example adapter similar to adapter 260 of catheter system 200 described above. Adapter 560 may include a body 563 that may be inserted into a bracket (e.g., into a slot thereof). The slot of the bracket may be open in a vertical direction (e.g., as shown in FIG. 1 ). Figure 3561, 562 may be inserted into the groove in a vertical direction. The adapter 560 may include protrusions 561, 562 extending from the body. The adapter 560 may be connected to the lumen 250 of the catheter system 200 (e.g., attached to the lumen) through a guidewire 565. The guidewire 565 may be attached to the body 563 through a slot and / or plate 564. The body 563 may include a hole through which the lumen 550 of the catheter system 200 may pass. The lumen 550 may include a plurality of lumens enclosed or nested together, as described above. Among the plurality of lumens 550, the lumen 250 may be the only lumen attached to the adapter 560. The protrusions 561, 562 may engage with opposing walls of the bracket to allow the system 100 to actuate the lumen 250 of the catheter system. Thus, moving the bracket engaged with the adapter 560 moves the lumen 250 attached to the adapter 560. As long as there is enough material to fix the adapter mechanically relative to the bracket, the shape of the adapter 560 can change. The shape of the adapter 560 can be shaped for the catheter system to limit the number of unique nesting designs of the bracket. The catheter system 200 may include a handle housing at the proximal end. The handle housing may be permanent and allow the adapter to be fixed to the actuator, platform or system 100, 200, or the handle housing may maintain a temporary packaging of the orientation of the lumen and the adapter and be removed when the catheter system is placed in the actuator, platform or system 100, 200. In this case, the adapter 560 may reside in the handle housing to be connected to the lumen 250, and the handle housing may include a hole that allows projections 561, 562 to penetrate to engage with the bracket. In other embodiments, the catheter system 200 does not have a handle housing.

[0049] Figure 7-8 An electronically controlled actuator or system 100c is shown as one embodiment of the system 100 and the catheter system 200c. The system 100c may include a plurality of brackets 620, for example including first to seventh brackets 621-627. Figure 1-2The bracket 120 shown in the figure can be moved along the support track 675. Each bracket 620 can include a groove (e.g., groove 651-657) for accommodating a corresponding adapter in a plurality of adapters 660 of the catheter system 200c. The adapter 660 can include the first to seventh adapters 661-667. The adapter 661-667 can be accommodated or nested in the groove of the corresponding bracket 621-627, and the groove can be open in the vertical direction. The lateral protrusion 695 of the adapter 660 can engage with the side of the groove to allow the bracket to apply force to the catheter system 200c through the adapter. Alternatively, the catheter system 200c can have a handle including a housing to provide a gripping surface. The housing can be removed before the adapter 660 is coupled to the bracket 620. Alternatively, the housing has never been included in the system 200c. Each adapter 660 can be coupled to a component of the catheter system 200c (such as one of the plurality of control features or lumens 650). The multiple lumens 650 may include an outer shaft, an intermediate shaft, a track assembly, a primary flexure, a secondary flexure, an inner shaft and / or a guidewire lumen, as described in U.S. Patent Publication No. 2019 / 0008640.

[0050] The carriage 620 can be mounted on the support rail 675 and can be moved along its longitudinal axis. The carriage 620 can be mounted to the side rail 673 extending along the support rail 675. Bolts and nuts 674 can be used to selectively connect (e.g., attach) the carriage 620 to the side rail 673. The carriage 620 can be attached to the side rail 673 individually or in groups. The carriage 620 can move along the support rail 675 by rotating the worm gear 672 controlled by the motor control system. The side rail 673 can be attached to the worm gear 672 by a slide 671. Alternatively, each carriage 620 may include a motor of a carriage drive system. Each motor may include a pinion (not shown) that can be meshed with a rack extending in the moving direction of the carriage. The carriage 620 can be moved along the rack by the actuation of the motor.

[0051] Each bracket 620 can include a load cell, such as load cells 631-637. Load cells 631-637 can form a "floating bridge" between the front plate 681 and the rear plate 682 on each bracket. Each load cell can be attached to both the front plate 681 and the rear plate 682. The front plate 681 and the rear plate 682 can also form a groove to accommodate a corresponding adapter (e.g., its lateral protrusion). Thus, the tension and / or compression force applied by the bracket to the catheter system through the bracket can be measured by the load cells 631-637. In some embodiments, a programmatic movement is performed (e.g., by turning a knob) to zero the load of a particular lumen. This can be performed as a best guess under balanced load. In implementing the load cells 631-637 (e.g., Figure 8The adapter 660 may include an alignment slot 692 that corresponds to the size and positioning of the protruding track 691.

[0052] Fig. 9 An electronically controlled actuator or system 100d and handle 703 of catheter system 200d are shown as another embodiment of system 100. Most catheter designs rely on a slide or knob actuated by the user to move one or more lumens of the catheter. For system 100d, the lumens can be actuated by a member or nest 722 connected to a bracket 720, which is driven by an alternative to manual manipulation (e.g., electromechanical, hydraulic, pneumatic). The lumens of catheter system 200d can be attached to an adapter (e.g., Figure 6 Adapter 560 is shown having a protrusion extending from the housing of catheter handle 703. The protrusion is snapped by nesting assembly 722 on bracket 720, which is driven by motor 721. If the components driving the lumen have sufficient support, the housing of handle 703 is not necessarily required, but a basic handle housing may be required to prepare the device and insert it into the patient.

[0053] Fig.10 A schematic front view of two nests 810 coupled to a lumen 812 is shown. The two nests 810 may be part of a plurality of nests coupled to the lumen 812. Each of the nests 810 may be coupled to a bracket (similar to Fig. 9 The nest 810 is shown coupled to the bracket 720, where the bracket 720 is part of the electronically controlled actuator 100d. The nest 810 can also be coupled to Figure 1 and Figure 2 The bracket 120 of the electronically controlled actuator 100 is shown. Figure 3 The bracket 320 of the electronically controlled actuator 100a is shown. Figure 4 and Figure 5 The bracket 420 or the electronically controlled actuator 100b shown Figure 7 and Figure 8 The bracket 620 of the electronically controlled actuator 200c is shown. Fig.10 Each of the illustrated nests 810 is engaged with or to a rack 814 that is attached to a separate lumen of the plurality of lumens 812. The coupling of each respective nest 810 to the rack 814 may be by an adapter (e.g., adapter 560 described above). Fig.10, each nest 810 is also shown having gear teeth 820 to engage a gear 822 actuated by a motor 824 .

[0054] Fig.11 Shown Fig.10 A schematic perspective view of a nest shown engaging one of the lumens. It can be seen that a rack 814 is attached to the lumen, which is one of the lumens 812. The rack 814 is driven by a pinion 818, which is actuated by a motor 816. Rotation of the pinion 818 can translate the rack 814 along the longitudinal axis 815 of the lumen 812. As shown in reference Figure 1 As described, such translational movement of the rack 814 attached to the lumen can be independent of the translational movement of the other lumens. An embodiment of the pinion 818 and rack 814 to enable translational movement of the lumen is Figure 3 The pinion 331a is shown as an alternative to engaging the rack 330. At the same time, when the teeth of the gear 824 engage the teeth 820 of the nest 810, the gear 822 can be actuated by the motor 824 to rotate the nest 810 in the rotational direction 817. Fig.11 As shown in FIG. 1 , the nest 810 can be rotated about the longitudinal axis 815 and thus also rotate the lumen 812. The respective lumens can be locked into rotational position by a locking or breaking mechanism (not shown). Fig.10 and Fig.11 The illustrated embodiment may allow the lumens to independently move translationally along and rotationally about the longitudinal axis 815. These translational and rotational movements of the lumens are independent of the movement of the other lumens in the plurality of lumens 812. The nest 810 is coupled to the bracket in a manner that allows translational and rotational movement of the lumens held by the bracket.

[0055] Fig.12 Another embodiment of using two motors to translate and rotate the lumen is shown in FIG. 830 is coupled to a gear for translational movement, as described above with reference to FIG. Figure 2 , 3 , 4, 7 and 9. Fig.12 As shown, a motor 836 is coupled to the bracket 830. The motor 836 has a worm gear 838 attached thereto to engage a gear 844 attached to the lumen 832. The lumen 832 can be one of a plurality of lumens nested together. The lumen 832 is rotatably coupled to the bracket 830 via an adapter 834, which can be held in the correct gear meshing position by a mechanism (not shown). The bracket 830 holds a load cell 846 to measure the force associated with the lumen 832. As shown in FIG. Fig.12 As can be seen in FIG. 8 , when motor 836 is actuated, it drives worm gear 838, causing gear 844 to rotate and thus lumen 832 to rotate. Fig.12The illustrated embodiment can induce both translational and rotational movement to lumen 832. When movement is stopped, the rotational positioning of lumen 832 can be locked by a retaining mechanism (not shown).

[0056] Figure 10-12 The embodiment of the present invention requires two motors 816, 824 to achieve translation and rotational movement to the lumen. However, in some embodiments, the number of motors can be reduced to one to reduce costs and increase the compactness of the electronically controlled actuation system and simplify operation. Fig.13 Such embodiments are schematically shown. Figure 2 , Figure 3 , Figure 4 , Figure 7 and Fig. 9 As depicted, lumen 852 is coupled to nest 850 in a manner that allows lumen 852 to translate with nest 850 along longitudinal axis 855 when nest 850 is translated by a motor (not shown). The coupling of lumen 852 to nest 850 also allows lumen 852 to rotate about longitudinal axis 855. The same motor may engage shaft 858 attached to bevel gear 854 through a "clutching" action. The engagement of bevel gears 854, 856 may allow shaft 858 to transmit rotational movement to bevel gear 856, and thus to lumen 852.

[0057] Fig.14 The schematic diagram shows Fig.13 870 is attached to pinion 874 and bevel gear 862 via shaft 872. Pinion 874 engages rack 876, which may be attached to lumen 877, as described above in Figure 10-11 876. In other embodiments, the attached lumen may also be arranged parallel to the rack 876. When the motor 870 is actuated, the rotation of the shaft 872 causes the pinion 874 to translate the rack 876 in the direction 878. This translational movement of the rack 876 may cause the attached lumen 877 to move accordingly. When the lumen is required to rotate, the assembly of the motor 870, the pinion 874, and the bevel gear 882 may be moved upward, for example, by clutching, so that the bevel gear 882 engages with another bevel gear 884 attached to the shaft 886. At the same time, the pinion 874 may be disengaged from the rack 876. In this case, the actuation motor 870 may cause the bevel gears 882 and 884 to transmit the rotational movement of the shaft 872 to the rotational movement of the shaft 886. The rotational movement of the shaft 886 may cause the lumen 877 to rotate (e.g., by a gear or belt / wheel mechanism).

[0058] In some embodiments, two or more lumens (e.g., two, three, four, five, or all lumens) can be controlled to move in translation and / or rotation simultaneously and independently. This makes it easy to perform surgeries that require moving two lumens simultaneously. Additionally, moving the lumens simultaneously in opposite directions is difficult to implement in conventional handles, but is facilitated in the disclosed embodiments. Such movement of the two lumens in opposite directions may be advantageous in eliminating undesirable instabilities (e.g., drift) in the distal end of the catheter system. By Figure 10-14 Another feature of the setup that becomes easier to implement is the independent clocking of the lumens, since each lumen can be rotated independently and locked when the rotational movement stops.

[0059] According to several embodiments, an independent auxiliary motor is included in (e.g., operably and mechanically coupled to) the actuator or catheter system 100, 200. The independent auxiliary motor can be mounted in a stationary position, or can be translated, rotated, and / or otherwise moved along the actuator platform or catheter system 100, 200 depending on the use. In some embodiments, an adapter is operably and / or mechanically attached or otherwise coupled to the motor, which allows the motor to interface with different catheter features (such as winding / translation of sutures or wires) to apply torque to the member or tack member. The actuator or catheter system 100, 200 may include a clamp or other mechanical feature for tack or attachment (e.g., guidewire tack).

[0060] According to several embodiments, the actuator platform or catheter system 100, 200 may include an internal pump (e.g., a peristaltic pump) configured and adapted to flush and / or aspirate one or more lumens of the catheter system. In some embodiments, the pump is configured and adapted to expand one or more balloons associated with the catheter system. One or more ports of the pump may be accessible to facilitate changes in saline, contrast media, or aspiration as needed or desired.

[0061] According to several embodiments, a sheath retainer is provided to fix or retain the sheath of the introducer or catheter system at a desired area before the patient entry point while the system 100, 200 is performing its delivery steps. The sheath retainer can be used to prevent the sheath from translating when translating the catheter (e.g., one or more internal lumens of the catheter system 200).

[0062] Fig.15A method of controlling a medical system including an electronically controlled actuator system (such as system 100) and a catheter system (such as catheter system 200) is presented. The method can be used with various different types of catheter systems and for performing various types of medical procedures. At step 1005, the method can include positioning the electronically controlled actuator system of the medical system relative to a patient. The electronically controlled actuator system can include a base and a frame extending along a longitudinal axis. A bracket or multiple brackets can be mounted with the frame and can be moved relative to the frame along the longitudinal axis. The bracket drive system can adjust the positioning of the bracket along the longitudinal axis to an initial configuration.

[0063] At step 1015, an incision can be made to access the patient's vasculature. In one example, a transfemoral approach to the heart can be used.

[0064] At step 1025, the distal end of the catheter system can be advanced into the vasculature of the patient. The distal end can be advanced into or adjacent to the anatomical region of the patient to continue the medical procedure.

[0065] At step 1035, the proximal end of the catheter system may be aligned relative to the electronically controlled actuator system. Optionally, the housing of the handle may be removed and / or an adapter may be attached at the proximal end to one or more lumens of the catheter system.

[0066] An adapter or adapters of the catheter system may be nested with or otherwise coupled to one or more brackets at step 1045. The adapter may be received within a slot of the bracket.

[0067] At step 1055, the carriage drive system may receive at least one control signal. The control signal may be based on a user input at a user interface. The control signal may be based on a force feedback system of an actuator system (e.g., comparing a force signal measured by a load cell with an allowable force limit of the lumen). The control signal may also be based on an automated program. The automated program may be based on an analysis of one or more images related to the positioning of the catheter system within an anatomical region of the patient.

[0068] At step 1065, the actuator system can adjust the positioning of one or more brackets along the longitudinal axis of the frame. The adjustment can be based on at least one control signal. The adjustment can actuate one or more lumens of the catheter system to facilitate the medical procedure.

[0069] In some embodiments, specific anatomical or procedural dimensions, measurements, and / or manipulations for a specific patient based on preliminary screening or advance planning can be pre-populated and input into the actuator or control system prior to surgery, and the electronically controlled actuator system 100 can be configured to automatically perform initial advancement and positioning manipulations (e.g., primary and secondary flexure manipulations, depth and / or height translation manipulations) of one or more lumens of the catheter system (e.g., for a replacement heart valve delivery system, the initial advancement and positioning manipulations can place the replacement heart valve in the desired approximate position within the heart). Then, the clinical professional can perform fine-tuning advancement and positioning manipulations.

[0070] Specific terms

[0071] As used herein, directional terms such as "top," "bottom," "proximal," "distal," "longitudinal," "lateral," and "end" are used in the context of the examples shown. However, the present disclosure should not be limited to the orientations illustrated. In fact, other orientations are possible and within the scope of the present disclosure. Terms related to circular shapes, such as diameter or radius, as used herein, should be understood to not require perfectly circular structures, but should apply to any suitable structure having a cross-sectional area that can be measured from one side to the other. Terms generally related to shape, such as "circular," "cylindrical," "semicircular," or "semi-cylindrical," or any related or similar terms, need not strictly conform to the mathematical definition of a circle or cylinder or other structure, but can encompass structures that are fairly close approximations.

[0072] Conditional language, such as "can, could, might or may", unless otherwise specifically stated or otherwise understood in the context of use, is generally intended to convey that certain instances include or do not include certain features, elements and / or steps. Thus, such conditional language is not generally intended to imply that one or more instances require these features, elements and / or steps in any way.

[0073] Unless specifically stated otherwise, linking language such as the phrase "at least one of X, Y, and Z" is generally understood in context to convey that an item, term, etc. can be X, Y, or Z. Thus, such linking language is generally not intended to imply that certain instances require at least one of X, at least one of Y, and at least one of Z to be present.

[0074] As used herein, the terms "approximately," "about," and "substantially" refer to an amount close to the stated amount that still performs the desired function or achieves the desired result. For example, in some instances, as the context may dictate, the terms "approximately," "about," and "substantially" may refer to an amount within 10% of the stated amount that is less than or equal to the stated amount. As used herein, the term "generally" refers to a value, amount, or characteristic that primarily includes or tends toward a particular value, amount, or characteristic. As an example, in some instances, as the context may dictate, the term "roughly parallel" may refer to something that deviates from being completely parallel by less than or equal to 20 degrees. All ranges include endpoints. Summary of the invention

[0076] Several illustrative examples of electronically controlled actuators have been disclosed. Although the present disclosure has been described according to certain illustrative examples and uses, other examples and other uses (including examples and uses that do not provide all the features and advantages set forth herein) are also within the scope of the present disclosure. Components, elements, features, actions or steps may be arranged or performed differently from the described manner, and components, elements, features, actions or steps may be combined, merged, added or omitted in various examples. All possible combinations and sub-combinations of the elements and components described herein are intended to be included in the present disclosure. No single or group of features are necessary or indispensable.

[0077] Certain features described in the context of separate embodiments in this disclosure may also be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment may also be implemented individually in multiple embodiments or in any suitable sub-combination. In addition, although features may be described above as working in certain combinations, one or more features from a claimed combination may be deleted from the combination in some cases, and the combination may be claimed as a sub-combination or a variation of a sub-combination.

[0078] Any part of any of the steps, processes, structures and / or devices disclosed or shown in one example of the present disclosure may be combined or used together (or substituted for) any other part of any of the steps, processes, structures and / or devices disclosed or shown in different examples or flow charts. The examples described herein are not intended to be separate and apart from each other. Combinations, variations and some embodiments of the disclosed features are within the scope of the present disclosure.

[0079] Although the operation can be depicted in the drawings or described in the specification in a particular order, it is not necessary to perform such operation in the particular order shown or in the order of performing all operations to achieve the desired result. Other operations that are not depicted or described can be incorporated into the example methods and processes. For example, one or more other operations can be performed before, after, simultaneously or between any operation in the described operation. In addition, in some embodiments, the operation can be rearranged or reordered. In addition, the separation of the various components in the embodiments described above should not be understood as requiring this separation in all embodiments, and it should be understood that the described components and systems can generally be integrated together in a single product or packaged in multiple products. In addition, some embodiments are also within the scope of the present disclosure.

[0080] In addition, although illustrative examples have been described, any examples with equivalent elements, modifications, omissions and / or combinations are also within the scope of the present disclosure. In addition, although certain aspects, advantages and novel features are described herein, not all such advantages may be achieved according to any particular example. For example, some examples within the scope of the present disclosure achieve an advantage or a group of advantages as taught herein, without necessarily achieving other advantages taught or suggested herein. In addition, some examples may achieve advantages different from those taught or suggested herein.

[0081] Some examples have been described in conjunction with the accompanying drawings. The drawings are drawn and / or shown to scale, but such scale should not be restrictive, because dimensions and ratios other than those shown are also conceivable and within the scope of the disclosed invention. Distances, angles, etc. are merely illustrative and may not have an exact relationship to the actual size and layout of the device shown. Components may be added, removed, and / or rearranged. In addition, the disclosure of any particular feature, aspect, method, property, characteristic, quality, attribute, element, etc. in conjunction with each example may be used in all other examples described herein. In addition, any method described herein may be practiced using any device suitable for performing the steps described.

[0082] For the purpose of summarizing the present disclosure, certain aspects, advantages and features of the present invention have been described herein. According to any specific example of the present invention disclosed herein, not all or any such advantages must be realized. Any aspect of the present disclosure is not necessary or indispensable. In many examples, devices, systems and methods can be configured differently from the devices, systems and methods illustrated in the drawings or descriptions herein. For example, the various functionality provided by the illustrated modules can be combined, rearranged, added or deleted. In some embodiments, additional or different processors or modules can perform some or all of the functionality described in the examples described and illustrated with reference to the drawings. Many implementation variations are possible. Any of the features, structures, steps or processes disclosed in this specification may be included in any example.

[0083] In summary, various examples of electronically controlled actuators and related methods have been disclosed. The present disclosure extends beyond the specifically disclosed examples to other alternative examples and / or other uses of the examples and certain modifications and equivalents thereof. In addition, the present disclosure explicitly contemplates that the various features and aspects of the disclosed examples can be combined or replaced with each other. Therefore, the scope of the present disclosure should not be limited by the specifically disclosed examples described above, but should only be determined by a clear reading of the claims.

Claims

1. A medical system comprising: An electronically controlled actuator system, the electronically controlled actuator system comprising: a frame extending along a longitudinal axis; a plurality of brackets mounted with the frame and movable relative to the frame along the longitudinal axis; a carriage drive system configured to adjust a position of each of the plurality of carriages along the longitudinal axis based on at least one control signal; as well as A catheter system for providing a passage in a body cavity, the catheter system comprising: remote; proximal; a plurality of lumens extending between the distal end and the proximal end; a plurality of adapters, each of the adapters being attached to a lumen of the plurality of lumens; Wherein each of the plurality of adapters is configured to couple to a corresponding bracket of the plurality of brackets such that adjusting the position of the corresponding bracket along the longitudinal axis actuates the attached lumen. 2 . The medical system of claim 1 , wherein each of the plurality of brackets is independently movable along the longitudinal axis. 3 . The medical system of claim 2 , wherein each of the plurality of brackets includes a nest coupled thereto, the nest configured to rotate about the longitudinal axis. 4 . The medical system of claim 3 , wherein each of the nests is configured to rotate independently about the longitudinal axis.

5. The medical system of claim 1, further comprising: A control system, the control system comprising: at least one computer-readable memory having executable instructions stored thereon; and one or more processors in communication with the at least one computer-readable memory and configured to execute the instructions to cause the system to at least: receiving an input signal; and The at least one control signal is generated based on the input signal.

6. The medical system according to claim 5, further comprising: A user interface is used to provide the input signal.

7. The medical system of claim 6, wherein the user interface is located remotely from the actuator system and is in wired or wireless communication with the control system.

8. The medical system of any of the preceding claims, wherein the plurality of lumens of the catheter system comprises an outer sheath assembly, an intermediate shaft assembly, a track assembly, and an inner shaft assembly.

9. The medical system of claim 6, further comprising: A first load cell is configured to measure a force applied by a first bracket of the plurality of brackets to a first lumen of the plurality of lumens.

10. The medical system of claim 9, wherein the first load cell is mounted on the first bracket and contacts the first adapter when a first adapter of the plurality of adapters is coupled to the first load cell.

11. The medical system of claim 9, further comprising: a user interface configured to display the force measured by the first load cell relative to an allowed force limit associated with the first lumen.

12. The medical system of claim 11, wherein the user interface is further configured to display an available range of motion of the first lumen based on the force measured by the first load cell and the allowed force limit.

13. The medical system of claim 11 or claim 12, wherein execution of the instructions further causes the medical system to: receiving a force signal from the first load cell; and generating the at least one control signal further based on a comparison of the force signal with the allowable force limit; Wherein the at least one control signal is configured to prevent the permissible force limit from being exceeded.

14. The medical system according to any one of claims 6, further comprising: A load cell is configured to measure a force applied to each lumen of the plurality of lumens by a corresponding bracket of the plurality of brackets.

15. The medical system of any of the preceding claims, wherein the at least one control signal is configured to adjust the positioning of at least two of the plurality of brackets along the longitudinal axis into a first group.

16. The medical system of any one of the preceding claims, wherein each of the plurality of brackets comprises a receiving slot configured to receive an adapter of the plurality of adapters therein.

17. The medical system of claim 16, wherein each of the plurality of adapters comprises one or more lateral protrusions extending perpendicular to the longitudinal axis, and each of the receiving slots comprises one or more upward protrusions configured to engage with the one or more lateral protrusions.

18. The medical system of any preceding claim, the proximal end of the catheter system comprising a handle housing comprising one or more housing components.

19. The medical system of claim 18, wherein the plurality of adapters protrude laterally outward from within the handle housing.

20. The medical system of claim 18, wherein the handle housing is removable.

21. The medical system of any preceding claim, wherein the frame is rotatable on an axis of rotation parallel to or substantially aligned along the longitudinal axis.

22. The medical system of claim 21, further comprising a first pivot mount connected to the first end of the frame and a second pivot mount connected to the second end of the frame, the first pivot mount and the second pivot mount being aligned along the rotation axis.

23. The medical system of any of the preceding claims, wherein the plurality of lumens are attached to the plurality of adapters via respective guidewires.

24. The medical system of any preceding claim, further comprising a base or table including an upper surface configured to support the frame.

25. The medical system of claim 24, further comprising a patient bed configured to support the base or table.

26. The medical system of any of the preceding claims, wherein the frame includes a pair of rails extending parallel to the longitudinal axis, and the plurality of brackets are mounted on the pair of rails.

27. The medical system of any of the preceding claims, wherein the carriage drive system comprises a motor for each of the plurality of carriages.

28. The medical system of claim 27, wherein the carriage drive system comprises a rack attached to the frame, and each of the motors includes a pinion that meshes with the rack.

29. The medical system of any one of the preceding claims, wherein each of the plurality of brackets comprises a limit switch or proximity switch for homing the bracket relative to the frame.

30. The medical system according to any of the preceding claims, wherein the catheter system may be any catheter system from a group of catheter systems comprising a plurality of universal adapters.

31. The medical system of claim 30, wherein the plurality of carriages are repositionable to receive any catheter system from the set of catheter systems in an initial preprogrammed spacing configuration.

32. The medical system of any of the preceding claims, wherein the at least one control signal is further based on an autonomous or semi-autonomous control algorithm.

33. A method of controlling a medical system, the method comprising: An electronically controlled actuator system for positioning the medical system relative to a patient, the electronically controlled actuator system comprising: a frame extending along a longitudinal axis; a bracket mounted with the frame and movable relative to the frame along the longitudinal axis; as well as a carriage drive system configured to adjust a positioning of the carriage along the longitudinal axis; making an incision to access the patient's vasculature; inserting a distal end of a catheter system through the incision into the vasculature of the patient, and advancing the distal end through the vasculature into or adjacent to an anatomical region of the patient; aligning a proximal end of the catheter system relative to the electronically controlled actuator system; coupling an adapter of the catheter system to the bracket; receiving at least one control signal at a control system of the electronically controlled actuator system; as well as The positioning of the carriage along the longitudinal axis is adjusted based on at least one control signal, and a lumen of the catheter system is thereby actuated.

34. The method of claim 33, further comprising receiving an input signal from a user interface and generating the at least one control signal based on the input signal.

35. The method of claim 33 or 34, further comprising: A force signal is received from the load cell and the at least one control signal is generated further based on the force signal.

36. The method of claim 35, further comprising: An available range of motion of the lumen is calculated based on the force signal measured by the load cell and an allowed force limit of the lumen.

37. The method according to any one of claims 33 to 36, further comprising: Prior to coupling the adapter of the catheter system with the bracket, the positioning of the bracket is adjusted to an initial preprogrammed position.

38. The method of any one of claims 33 to 37, wherein the catheter system comprises a plurality of lumens and a plurality of corresponding adapters, and the electronically controlled actuator system comprises a plurality of carriages.

Citation Information

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