Endoluminal medical imaging interface device and system - Patents.com

Abstract

The endoluminal medical imaging interface device includes an arm assembly having one or more longitudinal members and one or more joints coupled to the one or more longitudinal members, and a head assembly having a proximal portion coupled to a distal portion of the arm assembly and a distal portion coupled to the distal portion of the arm assembly. The distal portion of the head assembly includes a mechanical coupling and an electrical coupling configured to detachably connect to an endoluminal imaging catheter and transmit electrical signals between a console and the endoluminal imaging catheter. The arm assembly is configured to couple to a surface to maintain the head assembly in a first position and orientation relative to a patient without continuous support by an operator. Related devices, systems, and methods are also provided.

Description

[Technical field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates generally to endoluminal medical imaging systems, and more particularly to an endoluminal medical imaging interface device and system having an articulated arm assembly and mount for supporting a medical imaging catheter in an operating environment during an imaging procedure. [Background technology]

[0002] Diagnostic and therapeutic ultrasound catheters are designed for use inside many areas of the human body. In the cardiovascular system, two common diagnostic ultrasound techniques are intravascular ultrasound (IVUS) and intracardiac echocardiography (ICE). Typically, a single rotating transducer or an array of transducer elements is used to transmit ultrasound waves at the tip of the imaging catheter. The same transducer (or a separate transducer) is used to receive echoes from the tissue. Signals generated from the echoes are transferred to a console that allows for processing, storage, display, and / or manipulation of the ultrasound-related data.

[0003] The imaging catheter is typically controlled by an operator at the operating table. The catheter is inserted into a patient's lumen, such as a blood vessel, and the imaging tip of the catheter is navigated to a site to image the region of interest. The catheter can be navigated by manipulating a handle attached to the catheter and / or by manipulating one or more movement controls located on the handle. When the imaging tip reaches the region of interest, the operator must continue to hold the handle during the procedure to avoid accidentally moving the handle or triggering one of the movement controls on the handle. Placing the handle on the operating table or other surface can also cause undesired movement of the catheter inside the patient.

[0004] Conventional catheters often include a separate patient interface module (PIM) between the catheter handle and the console. The PIM can control various mechanical and electrical functions of the imaging catheter, such as ultrasound pulse generation, image processing, and rotation of the transducer within the catheter, as well as electrically isolate the catheter circuitry and the catheter power supply. However, the PIM also requires space on the operating table, and the operator must find a suitable surface to place the PIM during the procedure. Summary of the Invention [Problem to be solved by the invention]

[0005] The present disclosure describes an endoluminal medical imaging interface device and system that can advantageously improve the workflow of endoluminal medical imaging procedures. [Means for solving the problem]

[0006] For example, an endoluminal medical imaging system can include an articulated arm that is coupled or attached to a surface (e.g., an operating table) within the operating environment or procedure room and configured to couple to and support a proximal portion of an endoluminal imaging catheter, such as a handle, or a connector of the catheter. The interface device can support and stably maintain the imaging catheter in a position and orientation relative to a patient without continuous operator intervention. Such a configuration can allow for more consistent and stable positioning of the imaging catheter during a procedure. In some aspects, the interface device can also enable multitasking and improved control of an imaging procedure at the operating table. For example, the interface device can include one-handed control of the imaging catheter and shortcut controls to console functions.

[0007] In one embodiment, an endoluminal medical imaging interface device includes an arm assembly having one or more longitudinal members and one or more joints coupled to the one or more longitudinal members, the arm assembly including a proximal portion and a distal portion, and a head assembly coupled to the distal portion of the arm assembly. The head assembly has a proximal portion coupled to the distal portion of the arm assembly and a distal portion including a mechanical coupling configured to detachably connect to an endoluminal imaging catheter and an electrical coupling configured to detachably connect to the endoluminal imaging catheter for transmitting electrical signals between a console and the endoluminal imaging catheter. The arm assembly is configured to couple to a surface within a procedure room to maintain the head assembly in a first position and orientation relative to a patient, such that the endoluminal imaging catheter is held in place without continuous support by an operator.

[0008] In some embodiments, a first position and orientation of the head assembly is adjustable by moving the arm assembly. The head assembly can be configured to rotate about an axis defined by a rotatable joint. In some embodiments, the arm assembly is configured to advance the head assembly toward the patient to a second position while maintaining an orientation of the head assembly relative to the patient. In some aspects, the arm assembly has a first rotatable joint, a second rotatable joint distal to the first rotatable joint, a first longitudinal member extending between the first rotatable joint and the second rotatable joint, and a second longitudinal member extending between the first rotatable joint and the second rotatable joint. The head assembly can extend distal to the second rotatable joint. In some aspects, a proximal portion of the head assembly is coupled to the second rotatable joint. In some aspects, the head assembly is configured to articulate with the arm assembly. In some aspects, the arm assembly includes a telescoping assembly. In some embodiments, the apparatus can further include a mounting brace configured to fixedly couple to a surgical table, hi other embodiments, the mechanical coupling includes a recess for receiving a handle of the endoluminal imaging catheter.

[0009] According to another embodiment of the present disclosure, an endoluminal medical imaging system includes an endoluminal imaging catheter and an interface device, the imaging catheter including a flexible elongate member having a distal portion and a proximal portion, the flexible elongate member configured to be disposed within a body cavity of a patient, a handle coupled to the proximal portion of the flexible elongate member, and an endoluminal imaging assembly coupled to the distal portion and configured to acquire imaging data while the flexible elongate member is disposed within the body cavity, the interface device including an arm assembly having one or more longitudinal members coupled to one or more joints and coupled to a surface within a procedure room and configured to maintain the handle of the endoluminal imaging catheter in a first position and orientation relative to the patient when the handle is coupled to the interface device, and a head assembly coupled to a distal portion of the arm assembly, the head assembly including a mechanical coupling and an electrical coupling, the mechanical coupling and the electrical coupling being disposed at the distal portion of the head assembly and configured to be detachably coupled to the handle of the endoluminal imaging catheter.

[0010] In some embodiments, the head assembly includes a first user control configured to initiate a control signal transmitted across an electrical coupling to the imaging catheter. In some embodiments, the intraluminal imaging catheter comprises an intracardiac echocardiography (ICE) imaging catheter. In some embodiments, the mechanical coupling comprises a rotational coupling configured to transmit torque to a rotatable portion of the intraluminal imaging catheter. In other embodiments, the mechanical coupling comprises a recess for receiving a handle of the intraluminal imaging catheter. In yet other embodiments, the electrical coupling of the head assembly is configured to mate with an electrical coupling of the handle of the intraluminal imaging catheter such that electrical signals can pass between the handle and the head assembly.

[0011] Further aspects, features, and advantages of the present disclosure will become apparent from the following detailed description.

[0012] Exemplary embodiments of the present disclosure will now be described with reference to the accompanying drawings. [Brief description of the drawings]

[0013] [Figure 1] FIG. 1 is a schematic diagram of an ICE imaging system according to an embodiment of the present disclosure. [Diagram 2] FIG. 1 is a perspective view of an endoluminal imaging interface device coupled to a surgical table in accordance with an embodiment of the present disclosure. [Diagram 3] 1 is a perspective view of an endoluminal imaging interface device and a handle detached from an endoluminal imaging device according to an embodiment of the present disclosure. [Figure 4] 1 is a perspective view of an endoluminal imaging interface device and an attached handle of an endoluminal imaging device according to an embodiment of the present disclosure. [Diagram 5] 1 is a perspective view of a proximal end of a handle of an endoluminal imaging device according to an embodiment of the present disclosure. [Figure 6] FIG. 1 is a perspective view of a distal end of a head assembly of an endoluminal imaging interface device according to an embodiment of the present disclosure. [Figure 7] FIG. 13 is a top view of a head assembly of an endoluminal imaging interface device according to an embodiment of the present disclosure. [Figure 8] 1 is a diagram of a portion of a touch screen interface in communication with an endoluminal imaging interface device according to an embodiment of the present disclosure. [Figure 9] 1 is a perspective view of an endoluminal imaging interface device according to an embodiment of the present disclosure. [Figure 10] FIG. 1 is a perspective view of an endoluminal imaging interface device covered by a sterile sheath in accordance with an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0014] For purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitations to the scope of the present disclosure are intended. Any changes and further modifications to the described apparatus, systems, and methods, and any further applications of the principles of the present disclosure, as would normally occur to one of ordinary skill in the art to which the present disclosure pertains, are fully contemplated and included within the present disclosure. For example, while the medical imaging device and interface are described with respect to intracardiac echocardiography (ICE), it will be understood that it is not intended to be limited to this application. The system is equally well suited to any application requiring imaging within a confined cavity or body cavity. In particular, it is fully contemplated that features, components, and / or steps described with respect to one embodiment can be combined with features, components, and / or steps described with respect to other embodiments of the present disclosure. However, for the sake of brevity, multiple iterations of these combinations will not be described separately.

[0015] 1 is a schematic diagram of an ICE imaging system 100 according to an embodiment of the present disclosure. The system 100 may include an ICE catheter 110, a connector 124, a processing system 130, such as a console and / or computer, and a monitor 132. The ICE catheter 110 includes a tip assembly or imaging assembly 202, a flexible elongate member 208, and a handle 220. The flexible elongate member 208 includes a distal portion 204 and a proximal portion 206. The distal end of the distal portion 204 is attached to the tip assembly 202. The proximal end of the proximal portion 206 is attached to the handle 220, for example, by an elastic strain relief 212, for manipulation and manual control of the ICE catheter 110. The tip assembly 202 may include an imaging core having one or more ultrasound transducer elements (e.g., a transducer array) and associated circuitry. The handle 220 may include an actuator clutch and / or other steering control components for steering the ICE catheter 110, such as for deflecting the tip assembly 202 and the distal section 204, as described in more detail herein.

[0016] Although this disclosure refers to an ICE catheter, any suitable endoluminal imaging device is contemplated, such as an intravascular ultrasound (IVUS) device, an optical coherence tomography (OCT) device, an intracardiac echocardiography (ICE) device, a transesophageal echocardiography (TEE) device, an intravascular photoacoustic (IVPA) imaging device, and / or any suitable internal imaging device. In this regard, system 100 can be an endoluminal imaging system and device 110 can be an endoluminal imaging device (e.g., a catheter, a guidewire, a guide catheter, etc.). For example, system 100 can be an endoluminal ultrasound imaging system and device 110 can be an endoluminal ultrasound imaging system. Additionally, although the following disclosure may refer to an intraluminal device being placed within a patient's vasculature (e.g., blood vessels, arteries, veins, heart chambers, etc.), the following disclosure contemplates an intraluminal device being sized and shaped, structurally arranged, and / or otherwise configured to be placed within other internal structures or body lumens of a patient, such as the esophagus, intestine, or other internal structures imaged by an intraluminal imaging device. System 100 may be utilized in a variety of applications, such as transseptal luminal puncture, left atrial appendage closure, atrial fibrillation ablation, and valve repair, and can be used to image vessels and structures within a living body. Additionally, tip assembly 202 may include any suitable physiological sensors or components for diagnosis, treatment, and / or therapy.

[0017] 1, the handle 220 is coupled to an interface device 230, which may be coupled and / or attached to a surface, such as an operating table, a hospital bed, or any other suitable surface in a medical or surgical environment. In some embodiments, the interface device 230 may comprise an integrated unit configured to stably maintain the ICE catheter 110 in a position and orientation relative to the patient without constant support or intervention by an operator.

[0018] The device 230 communicates with the processing system 130 via the connector 124 and the cable 122. By coupling the handle 220 to the device 230, the ICE catheter 110 communicates with the processing system 130. It should be understood that in some aspects the handle 220 can also be referred to as a connector. In some aspects the handle 220 can be referred to as an adapter, coupling, and / or interface. For example, in some embodiments the handle 220 is not held by the operator, but is supported and / or suspended above the operating table and patient by the device 230. However, for simplicity, the term "handle" is used.

[0019] In some embodiments, the system 100 may further include a patient interface module (PIM). For example, the PIM may facilitate communication of signals between the processing system 130 and the ICE catheter 110 to control the operation of the tip assembly 202. This may include generating control signals to position the imaging assembly 202, generating signals to trigger transmitter circuitry, and / or forwarding signals acquired by the tip assembly 202 to the processing system 130. For echo signals, the PIM may forward received signals, and in some embodiments, perform preliminary signal processing before transmitting the signals to the processing system 130. In an example of such an embodiment, the PIM performs data amplification, filtering, and / or aggregation. According to one embodiment, the PIM also provides high and low voltage DC power to support the operation of the circuitry in the tip assembly 202. In some embodiments, the PIM may be included as part of the interface device 230. In this regard, in some embodiments, the PIM and device 230 may comprise a single integral component. In other embodiments, the PIM may be located between the device 230 and the connector 124 or within the handle 220. In other embodiments, such as the embodiment shown in FIG. 1, the system 100 may not have a PIM.

[0020] The connector 124 may be configured in any suitable configuration to interconnect with the processing system 130 and the monitor 132 for processing, storing, analyzing, manipulating, and displaying imaging data obtained from signals generated by the imaging core in the tip assembly 102. The processing system 130 may include one or more processors, memory, one or more input devices such as a keyboard, and / or any suitable command control interface device. The processing system 130 may be operable to facilitate the features of the ICE imaging system 100 described herein. For example, the processing system 130 may execute computer-readable instructions stored on a non-transitory tangible computer-readable medium. The monitor 132 may be any suitable display device, such as a liquid crystal display (LCD) panel, a light-emitting diode (LED) panel, or the like.

[0021] In operation, a physician or clinician advances the flexible elongate member 208 into a blood vessel in the cardiac anatomy. By controlling the handle 220, the physician or clinician can steer the flexible elongate member 208 to a position near a region of interest to be imaged. For example, actuators on the handle 220 can deflect the tip assembly 202 and distal portion 204 in the side-to-side plane, while other actuators can deflect the tip assembly 202 and distal portion 204 in the anterior-posterior plane, as discussed in more detail herein.

[0022] The imaging process may include activating ultrasonic transducer elements on the tip assembly 202 to generate ultrasonic energy. A portion of the ultrasonic energy is reflected by the region of interest and surrounding anatomical structures, and ultrasonic echo signals are received by the ultrasonic transducer elements. The connector 124 transfers the received echo signals to the processing system 130, where an ultrasound image is reconstructed and displayed on the monitor 132. In some embodiments, the processing system 130 may control the activation of the ultrasonic transducer elements and the repletion of the echo signals. In some embodiments, the processing system 130 and the monitor 132 may be part of the same system.

[0023] FIG. 2 illustrates an endoluminal medical imaging interface device 230 according to some embodiments of the present disclosure. The device 230 may be included as part of the ICE imaging system 200 shown in FIG. The device 230 is shown coupled to an operating table 50. In some aspects, the device 230 can be attached, secured, fixed, and / or otherwise coupled to various surfaces, such as the operating table 50, a hospital bed, a rotating table, a counter, or any other suitable surface. The device 230 has a proximal portion 332 coupled to the operating table, a distal portion 234, and a number of adjustable or manipulable mechanical components that allow the attached endoluminal imaging device (e.g., 210) to be supported and maintained at a position and / or orientation relative to the patient. The device 230 can be adjusted to maintain the distal portion 234 in a position and orientation suitable for an endoluminal imaging procedure. For example, in some embodiments, the device 230 can be detachably coupled to the handle 220 of the ICE catheter 210. Before and / or during the imaging procedure, device 230 can be connected to handle 220 of ICE catheter 210 to establish a mechanical and / or electrical connection. After the imaging procedure, handle 220 can be disconnected from device 230 in a non-destructive manner. Device 230 can be adjusted or moved to position ICE catheter 210 near the entry point of the patient and oriented so that distal portion 234 of device 230 points toward the entry point. Device 230 is configured to maintain the same position and / or orientation of ICE catheter 210 without continued support or intervention from the operator (e.g., by holding handle 220).

[0024] The device 230 has an arm assembly 240 and a head assembly 250. The arm assembly 240 includes a first longitudinal member 242 and a second longitudinal member 244 disposed distally of the first longitudinal member 242. The arm assembly 240 further includes a first joint 246 coupled to and disposed between the first longitudinal member 242 and the second longitudinal member 244, and a second joint 248 coupled to and disposed between the second longitudinal member 244 and the head assembly 250. In other embodiments, the device 230 can have fewer or more longitudinal members and / or joints. For example, by increasing the number of longitudinal members and rotatable joints, the device 230 can exhibit more degrees or modes of movement, potentially allowing for more positioning by the operator. The device 230 can provide telescopic movement of the head assembly 250 relative to the operating table 50.

[0025] The first and second joints 246, 248 shown in FIG. 2 are rotatable joints that facilitate rotation of the first and second longitudinal members 242, 244 and the head assembly 250 relative to one another. For example, the first joint 246 facilitates rotation of the second longitudinal member 244 about a first axis relative to the first longitudinal member 242, and vice versa. Because the first longitudinal member 242 is coupled to the operating table 50, rotating the second longitudinal member 244 about the first axis via the first joint 246 can move the second longitudinal member 244 toward or away from the operating table 50. Similarly, the second joint 248 facilitates rotation of the head assembly 250 about a second axis relative to the second longitudinal member 244.

[0026] The arm assembly 240 further includes a telescoping assembly 260 coupled to the first longitudinal member 242. The telescoping assembly 260 can enable the arm assembly 240 to extend upward. By actuating the telescoping assembly 260 to extend upward, the head assembly 250 can be moved to an appropriate or desired height to perform an intraluminal imaging procedure. In the embodiment of FIG. 2, for example, the telescoping assembly 260 facilitates extension of the arm assembly 240 upward along or parallel to the first axis of the first joint 246. In other embodiments, the telescoping assembly 260 facilitates extension of the arm assembly 240 along other axes or directions. The telescoping assembly 260 of FIG. 2 may be referred to as being coupled to the first longitudinal member 242. However, in some aspects, the first longitudinal member 242 can be described as having a telescoping assembly 260 such that the telescoping assembly 260 allows the first longitudinal member 242 to telescope or extend along a direction that increases the length of the first longitudinal member 242. In other embodiments, the telescoping assembly 260 can be included in or coupled to other components of the device 230, such as the first and / or second joints 246, 248. In some embodiments, the telescoping assembly 260 includes a telescoping member that is slidably received within a lumen of a longitudinal member (e.g., the first and / or second longitudinal members 242, 244). The telescoping assembly 260 can also include a locking assembly configured to lock the telescoping member in place to prevent the telescoping member from sliding in one or more directions within the lumen of the longitudinal member. In some embodiments, the telescoping assembly 260 can include more than one telescoping member and / or more than one telescoping assembly at various points along the arm assembly 240 and / or head assembly 250. By increasing the number of telescoping members and / or telescoping assemblies, the device 230 may exhibit more degrees of freedom or modes, providing the operator with a greater variety of possible positions, orientations, and configurations of the device 230.

[0027] The device 230 is attached to the operating table 50 via a mounting bracket 270 or mounting brace. The mounting bracket 270 is configured to securely fasten to the operating table 50, or any other suitable surface, and couple to the device 230 to support and / or secure the device 230 relative to the operating table 50. In some embodiments, the mounting bracket 270 can be part of the device 230, such that the mounting bracket 270 is securely attached to the arm assembly 240. In some embodiments, the mounting bracket 270 can be configured to slide along the surface of the operating table 50 while supporting and maintaining the position and / or orientation of the device 230.

[0028] 3 and 4, the head assembly 250 of the endoluminal imaging interface device 230 is shown along with the handle 220 of the ICE catheter 210. The head assembly 250 is coupled to the distal portion 234 of the arm assembly 240. The catheter 210 is configured to be removably coupled to the device 230 via the head assembly 250. In FIG. 3, the handle 220 of the ICE catheter 210 is shown separated from the device 230. The handle 220 is coupled to the proximal portion 206 of the flexible elongate member 208 of the ICE catheter 210 via a strain relief 212. In some embodiments, the flexible elongate member 208 includes one or more pull wires extending along the length of the device. For example, the flexible elongate member 208 can include a pull wire or multiple pull wires extending from the handle 220 to a distal portion of the flexible elongate member 208. The pull wires may be configured to impart movement of the distal portion of the flexible elongate member 208, such as bending, folding, or flexing. The pull wires may be controlled by one or more controls or input devices of the ICE catheter 210, allowing a user to control movement of the distal portion of the ICE catheter 210 while navigating the ICE catheter 210 through a lumen or other internal structure of a patient. In some embodiments, the controls or input devices that provide control of the pull wires, and thus the distal portion of the flexible elongate member 208, are located in the handle 220. However, in other embodiments, the controls may be located in other portions of the ICE catheter 210 or may be located in other portions of the system 200, such as the interface device 230, the processing system 130, and / or the monitor 132.

[0029] The ICE catheter 210 extends distally of the handle 220. The head assembly 250 is maintained in a first position and a first orientation relative to the patient. The head assembly 250 can be moved to a second position and a second orientation by adjusting one or more components of the arm assembly 240 and / or by moving the head assembly 250 relative to the arm assembly 240. For example, the head assembly 250 can be moved to the second orientation by rotating the head assembly 250 relative to the arm assembly 240 via the second joint 248.

[0030] The handle 220 of the ICE catheter 210 is configured to be received within the mechanical interface 252 of the head assembly 250. In FIG. 4, the handle 220 is shown coupled to the head assembly 250 of the device 230. The proximal portion 228 of the handle 220 is received within the mechanical interface 252 of the head assembly 250. Now, when coupled to the head assembly 250, the ICE catheter 210 is also maintained in a first orientation relative to the patient without continued support and / or intervention by the operator. In this configuration, the head assembly 250 of the device 230 and the ICE catheter 210 are held and / or suspended above the operating table 50. By maintaining the ICE catheter 210 and the head assembly 250 above the operating table 50, the ICE catheter 210 may be stable and less susceptible to unintended movement of the patient, the operator, or the operating table 50. As discussed below, the device 230 can be configured to control aspects of the ICE catheter 210, such as rotation, extension (advancement), or image capture, while maintaining the head assembly 250 in a first position and / or a first orientation.

[0031] In some embodiments, the handle 220 of the ICE catheter 210 includes mechanical controls for controlling movement of the distal portion of the ICE catheter 210. For example, as shown in FIG. 4, the handle 220 can include a ring 226 slidably coupled to an outer surface of the handle 220. The ring 226 can be directly or indirectly coupled to one or more pull wires such that movement of the ring acts on one or more pull wires to cause movement of the distal portion of the ICE catheter 210. The ring 226 can be coupled to the flexible elongate member 208 such that rotation of the handle 220 rotates the flexible elongate member 208. For example, translating or retracting the ring 226 proximally toward the head assembly 250 can control bending of the distal portion of the ICE catheter 210 via one or more pull wires, and rotating the ring 226 can rotate the ICE catheter 210. The mechanical controls may be supplemented with a rotational control 254 that controls the rotational portion of the ICE catheter 210 to provide the degrees of freedom or modes of motion required by the operator to acquire images of the patient's anatomy. Such a configuration may reduce the number of controls required to control the distal portion of the ICE catheter 210.

[0032] FIG. 5 shows a proximal end of a handle 220 of an ICE catheter 210, according to some embodiments. The handle 220 includes a mechanical interface 222 and an electrical interface 229 configured to couple to a mechanical interface 252 and an electrical interface 259 of a head assembly 250 shown in FIG. 6. With reference to FIG. 5, the mechanical interface 222 includes a latch connector 224 and a torque transmission member 221. The torque transmission member 221 of the handle 220 shown in FIG. 5 engages with a corresponding torque transmission member 256 disposed within the mechanical interface 252 of the head assembly 250 shown in FIG. 6. In some aspects, the torque transmission member 221 of FIG. 5 can be referred to as a male connector and the torque transmission member 256 of FIG. 6 can be referred to as a female. In the illustrated embodiment, the torque transmission member 221 of FIG. 5 includes a cylindrical protrusion including a flat shelf 223 portion. 5. The torque transmitting member 256 of FIG. 6 may include a circular recess with a flat ceiling configured to engage the flat shelf 223 of the torque transmitting member 256 of FIG.

[0033] In FIG. 5, the handle 220 also includes an electrical interface 229 disposed within the mechanical interface 222. The electrical interface 229 includes a plurality of electrical contacts 225 disposed around a recess in the mechanical interface 222. In some embodiments, each of the plurality of electrical contacts 225 may provide electrical communication over a separate communication line. For example, in some embodiments, the electrical interface 229, 259 may include 20, 21, or 22 electrical contacts associated with 20, 21, or 22 separate communication lines. In other embodiments, the electrical interface 229 may have fewer or more electrical contacts. The electrical contacts 225 of the electrical interface 229 of FIG. 5 may couple to corresponding electrical contacts in the head assembly 250 to establish electrical communication between the device 230 (and / or the processing system 130) and the ICE catheter 210.

[0034] FIG. 7 is a top view of the head assembly 250 shown in FIGS. 1-4 and 6. The head assembly 250 is rotatably coupled to the second longitudinal member 244 via the second joint 248. A control area 251 disposed on the head assembly 250 includes a number of user controls and input devices that allow an operator to control various aspects of an intraluminal medical imaging procedure. For example, the rotation control 254 can be twisted, pushed, or otherwise manipulated by the operator to control the rotation of a rotatable portion of an imaging device such as the ICE catheter 210. The rotation control 254 can initiate an electrical signal, such as a control signal, having instructions to activate a rotation mechanism, such as a motor, in the head assembly 250. By activating the rotation mechanism, the torque transmission member 256 of the head assembly 250 can transmit torque to the torque transmission member 221 of the handle 220 of the ICE catheter 210, which controls the rotation of the rotatable portion of the ICE catheter 210. In some embodiments, the rotatable portion of the ICE catheter 210 includes an elongated drive shaft and an imaging assembly 202 disposed at a distal portion 204 of the drive shaft.

[0035] The control area 251 further includes a first shortcut control 253 and a second shortcut control 255 configured to control aspects of the imaging assembly 202 of the ICE catheter 210. For example, the first shortcut control 253 may initiate an electrical signal having instructions for the imaging assembly 202 to capture one or more images or to perform an imaging sequence or imaging procedure. The second shortcut control 255 may control other aspects of the imaging procedure, such as a freeze function. In some embodiments, the specific functions of the first and second shortcut controls 253, 255 can be set by an operator. For example, the operator may use an operator interface including the monitor 132 to select and / or program the functions performed by one or more of the shortcut controls 253, 255. The control area 251 also includes a settings navigation button 257 that provides access to additional imaging procedure settings that are adaptive to user preferences and procedure requirements. The control area 251 may include any suitable input device, such as a button, a toggle, a switch, or the like.

[0036] FIG. 8 illustrates a portion of an operator interface 310 that may be used with the controls shown in FIG. 7. The interface 310 may include a first image setting control 312 and a second image setting control 314. In some embodiments, the first and second image setting control 312, 314 may be used with the shortcut control 253, 255 shown in FIG. 7. For example, the first and second image setting control 312, 314 may be used to set image acquisition settings when the first shortcut control 253 is used to acquire an image. In some embodiments, the operator interface 310 has a graphical user interface (GUI). The graphical user interface may be used with an interface device such as a display and a mouse and / or keyboard. In some embodiments, the GUI is used with a touch screen display. In some embodiments, the operator interface 310 and / or the GUI may be implemented on the head assembly 250, such as a touch screen display. In other embodiments, the operator interface 310 and / or the GUI may be implemented on a monitor 132 that is separate from the interface device 230.

[0037] FIG. 9 is a perspective view of the endoluminal medical imaging interface device 230 of FIGS. 1-4, 6, and 7, with the head assembly 250 shown suspended above the operating table 50. In some aspects, the device 230 may be rotated above the operating table 50 to telescope or extend upwardly to support the head assembly 250 above the patient. In some embodiments, the device 230 may be configured and / or intended to remain coupled to the operating table 50 for an extended period of time, or even indefinitely, through multiple uses of the device 230. Thus, the device 230 may be considered non-sterile. The ICE catheter 210 that couples to the head assembly 250 may be a disposable device or may be configured for multiple uses. In some cases, the ICE catheter 210, including the handle 220, may be considered sterile, since the ICE catheter 210 may be discarded after a single use. The ICE catheter 210 can also be sterilized between multiple uses and therefore can be sterile during use.

[0038] As shown in FIG. 10, to maintain the safety and sterility of the operating environment, a sterile sheath 280 is placed over the device 230 to isolate the non-sterile device 230 from the sterile operating environment. In some embodiments, the sheath 280 can be disposable, e.g., after a single use. In some embodiments, the sheath 280 is initially packaged onto the sterile ICE catheter 210. An operator can first couple the handle 220 of the ICE catheter 210 to the head assembly 250 via the mechanical and electrical interfaces 252, 259, and then slide the sheath 280 out of the packaged ICE catheter 210 and simultaneously slide the sheath 280 onto the non-sterile interface device 230. In other embodiments, a new sheath can be placed onto the device 230 before coupling the handle 220 of the ICE catheter 210 to the head assembly 250 of the device 230.

[0039] The devices, systems, and methods described herein may be implemented using any of the methods disclosed herein, including, for example, U.S. Provisional Application Nos. 62 / 401,464, filed September 29, 2016, 62 / 401,525, filed September 29, 2016, 62 / 402,483, filed September 30, 2016, 62 / 403,431, filed October 3, 2016, 62 / 404,432, filed October 3, 2016, 62 / 405,433, filed October 3, 2016, 62 / 406,434, filed October 3, 2016, 62 / 407,435, filed October 3, 2016, 62 / 409,441, filed October 3, 2016, 62 / 401,464, filed September 29, 2016, 62 / 401,525, filed September 29, 2016, 62 / 402,483, filed September 30, 2016, 62 / 403,431, filed October 3, 2016, 62 / 403,431, filed October 3, 2016, 62 / 403,431, filed October 3, 2016, 62 / 403,432, filed October 3, 2016, 62 / 403,431 ... No. 62 / 403,311, filed Oct. 3, 2016, U.S. Provisional Application No. 62 / 403,278, filed Oct. 3, 2016, U.S. Provisional Application No. 62 / 403,267, filed Oct. 3, 2016, U.S. Provisional Patent Application No. 62 / 468,046, filed Oct. 3, 2016, and U.S. Patent Application Publication No. 2008 / 0009745.

[0040] Those skilled in the art will recognize that the above-described devices, systems, and methods can be modified in various ways. Thus, those skilled in the art will appreciate that the embodiments encompassed by the present disclosure are not limited to the specific exemplary embodiments described above. In this regard, while exemplary embodiments have been shown and described, a wide range of modifications, changes, and substitutions are contemplated in the preceding disclosure. It is understood that such variations can be made to the above without departing from the scope of the present disclosure. Thus, it is appropriate that the appended claims be broadly construed in a manner consistent with the present disclosure.

Claims

1. 1. An endoluminal medical imaging interface device, comprising: an arm assembly having one or more longitudinal members and one or more joints coupled to the one or more longitudinal members, the arm assembly including a proximal portion and a distal portion; a head assembly coupled to a distal portion of the arm assembly, a proximal portion coupled to a distal portion of the arm assembly; and a mechanical coupling configured to detachably connect to a handle of an endoluminal imaging catheter, the handle configured to be held by a user to navigate the endoluminal imaging catheter by manipulating the handle and / or by manipulating one or more motion controls disposed on the handle; and an electrical coupling configured to detachably connect to the intraluminal imaging catheter to transmit electrical signals between a console and the intraluminal imaging catheter; A distal portion including The head assembly having having the arm assembly is configured to couple to a surface within a procedure room to maintain the head assembly in a first position and orientation relative to a patient, such that the intraluminal imaging catheter is held in place without continuous support by an operator. Device.

2. The apparatus of claim 1 , wherein the first position and orientation of the head assembly is adjustable by moving the arm assembly.

3. The apparatus of claim 1 , wherein the head assembly is configured to rotate about an axis defined by a rotatable joint.

4. The apparatus of claim 1 , wherein the arm assembly is configured to advance the head assembly toward the patient to a second position while maintaining an orientation of the head assembly relative to the patient.

5. The arm assembly includes: A first rotatable joint; a second rotatable joint distal to the first rotatable joint; a first longitudinal member extending proximally of the first rotatable joint; a second longitudinal member extending between the first rotatable joint and the second rotatable joint; having the head assembly extends distally of the second rotatable joint; 2. The apparatus of claim 1.

6. The apparatus of claim 5 , wherein the proximal portion of the head assembly is coupled to the second rotatable joint.

7. The apparatus of claim 5 , wherein the head assembly is configured to articulate with the arm assembly.

8. The apparatus of claim 5 , wherein the arm assembly comprises a telescoping assembly.

9. The apparatus of claim 1 , further comprising a mounting brace configured to fixedly couple to a surgical table.

10. The device of claim 1 , wherein the mechanical coupling has a recess for receiving a handle of the endoluminal imaging catheter.

11. 1. An endoluminal medical imaging system having an endoluminal imaging catheter and an interface device, comprising: the intraluminal imaging catheter comprising: a flexible elongate member having a distal portion and a proximal portion, the flexible elongate member being configured to be disposed within a body lumen of a patient; a handle coupled to a proximal portion of the flexible elongate member, the handle configured to be held by a user to navigate the endoluminal imaging catheter by manipulating the handle and / or by manipulating one or more motion controls disposed on the handle; an endoluminal imaging assembly coupled to the distal portion and configured to acquire imaging data while the flexible elongate member is disposed within a body lumen; having The interface device, an arm assembly having one or more longitudinal members coupled to one or more joints and configured to couple to a surface within a procedure chamber to maintain the handle of the endoluminal imaging catheter in a first position and orientation relative to the patient when the handle is coupled to the interface device; a head assembly coupled to a distal portion of the arm assembly, the head assembly having a mechanical and electrical coupling disposed at the distal portion of the head assembly and configured to detachably couple to the handle of the intraluminal imaging catheter; having system.

12. The system of claim 11 , wherein the head assembly includes a first user control configured to initiate a control signal transmitted across the electrical coupling to the imaging catheter.

13. The system of claim 11 , wherein the intraluminal imaging catheter comprises an intracardiac echocardiography (ICE) imaging catheter.

14. The system of claim 11 , wherein the mechanical coupling comprises a rotational coupling configured to transmit torque to a rotatable portion of the intraluminal imaging catheter.

15. The system of claim 11 , wherein the mechanical coupling comprises a recess for receiving the handle of the intraluminal imaging catheter.

16. 12. The system of claim 11, wherein the electrical coupling of the head assembly is configured to mate with an electrical coupling of the handle of the intraluminal imaging catheter such that electrical signals can be passed between the handle and the head assembly.

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