RU2795943C2 - Wireless control of transesophageal echocardiography - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: group of inventions relates to the examination and visualization of the patient's organs using transesophageal echocardiography (TEEchoCG), namely to a TEE probe, as well as to a method of wireless control of such a probe. The gastroscope of the probe is detachably connected to the handle and contains an ultrasonic transducer in the distal part for obtaining ultrasound imaging data. The gastroscope wireless communication module is connected to the handle and is configured to receive a command signal from a console located at a distance from the TEE probe and transmit ultrasound imaging data to the console. The microcontroller of the wireless communication module is configured to transmit an electrical signal to the gastroscope to control the movement of the distal part of the gastroscope in response to the received command signal. The handle interface is located in the distal part of the handle. The gastroscope interface is located in the proximal part of the gastroscope. The handle and the gastroscope are detachably connected to each other by a handle interface and a gastroscope interface. The handle interface is configured to transmit an electrical signal to the gastroscope via the gastroscope interface to control the distal portion of the gastroscope. The wireless communication module is located inside the handle. The housing of the wireless communication module is connected to the handle. When the wireless communication module is connected to the handle, the wireless communication module transmits an electrical signal to the gastroscope.

EFFECT: it is possible to disassemble and reassemble the TEE probe using the same or different components to speed up medical operations for the doctor and the patient, and reduce the risk of damage to the TEE probe during cleaning procedures through the use of removable components.

15 cl, 19 dwg

Description

The field of technology to which the invention belongs

The present invention relates primarily to the examination and imaging of the patient's organs using transesophageal echocardiography TEE (TEE, TransEsophageal Echocardiography). For example, some embodiments of the present invention are suitable for modular adaptation of TEE probes for use with one or more gastroscope modules. Other embodiments of the present invention are suitable for wireless TEE procedures.

State of the art

Monitoring the condition and functioning of the patient's heart can be a difficult and dangerous procedure. Echocardiography can reduce the risk of harm to the patient through the use of ultrasound imaging techniques. When recording an echocardiogram, the therapist uses an ultrasound probe containing one or more ultrasound transducers to obtain images of the patient's heart from various angles. Ultrasound transducers emit energy in the form of ultrasonic waves to create an image of the heart. Ultrasonic waves are partly reflected by inhomogeneities due to tissue structure, red blood cells and other elements of interest. Echo signals or reflected ultrasonic waves are received by the ultrasonic transducer and transmitted to the signal processor. The signal processor processes the received ultrasound echoes to obtain an image of the heart in the vicinity of the location of the ultrasound transducer.

One common echocardiographic procedure is transthoracic TTEchocardiography (TTE), which involves placing an ultrasound transducer on the patient's chest or abdomen to image the heart from various angles. Although TTE is a relatively non-invasive procedure, the ultrasound waves must travel through several layers of tissue and bone to reach the heart, and the echo waves must travel back through the same tissue and bone to reach the ultrasound transducer. These thick layers of tissue and bone can attenuate echoes and degrade the quality of the resulting image.

Transesophageal echocardiography TEE (TEE) involves obtaining an ultrasound image of the heart using a TEE probe placed inside the patient's esophagus. TEE probes also use ultrasound waves to image the patient's heart. Transesophageal echocardiography may be advantageous because the heart is located close to the esophagus, which may produce better images. To acquire an image with a TEE probe, a doctor inserts a gastroscope containing an ultrasound transducer into the patient's esophagus and guides the ultrasound transducer to an area close to the heart. The physician manipulates the distal end of the gastroscope inside the patient's esophagus to direct the ultrasound transducer to the desired location and maintain contact with the esophageal wall to facilitate the transmission and reception of ultrasound waves.

Conventional TEE probes include a handle and a gastroscope containing an ultrasound transducer and an elongated body connected to the handle. The handle can also be connected to an interface cable that leads to the console. In some conventional designs, the handle, gastroscope, and cantilever interface cable form a single assembly in which the individual components are permanently attached to each other. In other words, conventional designs do not provide for a physician or other user to occasionally separate the gastroscope from the handle and reattach to the handle.

The size and shape of the gastroscopic portion of the TEE probe that the physician uses to acquire ultrasound images may depend on the physiology of the patient and the particular type of image the physician wants to obtain. In other words, when a physician wishes to acquire an ultrasound image of a patient's heart, the physician must select a gastroscope that matches the size and configuration of the patient's physiology. Since conventional TEE probes contain a permanently attached gastroscope and other components, the clinician must have a separate TEE probe containing a handle and a cantilever interface cable for each gastroscope configuration that the clinician may use in their practice. And this is true, although the handle and console interface cable do not change from gastroscope to gastroscope.

Cleaning conventional TEE probes can be difficult and may damage the components of the TEE probe. For example, a gastroscope that comes into contact with a patient's physiology may require more rigorous cleaning, while cleaning of the handle and console interface cable may be less rigorous. Difficulty in cleaning the TEE probe can damage the components of the TEE probe.

In addition, in traditional transesophageal echocardiography, the doctor uses an X-ray image of the patient's esophagus to direct the TEE probe to the right place, which exposes the doctor to radiation, and the doctor must constantly and steadily hold the handle of the TEE probe in his hand for a long time and often at an uncomfortable angle.

A wireless ultrasound monitoring device is known in the prior art (WO 2010/020939) in which imaging data from a transducer is transmitted wirelessly to the main imaging system. A control device for intravascular devices is also known (WO 2017/060439) in which instructions provided as input to a steering controller are converted into control signals for controlling an intravascular device.

Disclosure of the essence of the invention

Embodiments of the present invention provide an improved transesophageal echocardiography (TEE) probe for imaging an organ. For example, the TEE probe may include components such as a gastroscope and a handle that are releasably connected to each other to allow one or more components to be detached and replaced. The systems, devices, and methods described herein advantageously enable a clinician or user to disassemble and reassemble a TEE probe using the same or different components. This advantage speeds up medical operations for the doctor and the patient, and reduces the risk of damage to the TEE probe during cleaning procedures.

The present invention also describes TEE probes that can be controlled remotely or wirelessly. Embodiments of the present invention also provide a TEE probe comprising a wireless communication module capable of receiving and transmitting electrical signals. For example, the wireless communication module may be configured to receive a command signal from a remote user, allowing the remote user to remotely or wirelessly control various aspects of the transesophageal echocardiography procedure.

The wireless communication module may also be configured to transmit ultrasound imaging data to a console located at or near the remote user's location to enable the remote user to view the ultrasound image. This can reduce the doctor's radiation dose in the operating room and simplify the TEE procedure. In addition, a TEE probe equipped with a wireless communication module may include the removable components described above, and realize both the advantage of using a wireless communication module and the advantage of using removable or modular components.

In accordance with an exemplary embodiment of the invention, a probe for transesophageal echocardiography (TEEchoCG probe) is provided. The TEE probe includes a handle, which has a proximal part, a distal part, and a handle interface located in the distal part. The TEE probe may further comprise a gastroscope connected to the handle and configured to be placed in the patient's esophagus. The gastroscope may include a proximal part, a distal part, an ultrasound transducer located in the distal part of the gastroscope and configured to receive ultrasound imaging data, as well as a gastroscope interface located in the proximal part of the gastroscope. The handle and the gastroscope can be releasably connected to each other by a handle interface and a gastroscope interface, so that when these interfaces are connected to each other, the handle interface is capable of transmitting an electrical signal to the gastroscope through the gastroscope interface to control the movement of the distal parts of the gastroscope.

According to some embodiments of the invention, the ultrasound transducer is an array of ultrasound transducers and the gastroscope comprises a microbeamformer coupled to the array of ultrasound transducers. The microbeamformer may be located at the distal end of the gastroscope. In some embodiments, the handle includes a beamformer coupled to an array of ultrasonic transducers. In other embodiments, the gastroscope comprises a microbeamformer coupled to an array of ultrasound transducers and to the beamformer. The handle interface and the gastroscope interface may, in some cases, be a spring-loaded pin interface. At least one of the elements - a handle or a gastroscope - may contain a latch for fixing the handle interface and the gastroscope interface.

According to some embodiments, the gastroscope includes an actuator and a traction cable connected to the actuator and the distal portion of the gastroscope. The executive body can be configured to control the movement of the distal part of the gastroscope. The handle may contain a controller connected to the executive body and ultrasonic transducer. The executive body may contain a motor. The gastroscope may include a force sensor, which is located in the distal part of the gastroscope, and which can be configured to detect the force applied to the distal part of the gastroscope. In some cases, the TEE probe additionally contains a force sensor controller connected to the force sensor and the actuator. The force sensor controller may be configured to control actuation of the traction cable by the actuator based on the force measured by the force sensor. The force sensor may include a flexible base located around the distal part of the gastroscope. In other embodiments, the handle includes a console interface at the proximal portion of the handle. The interface to the console may be at least one of the following: a USB interface or a spring pin interface.

In other embodiments, the TEE probe includes a gastroscope capable of being connected to a handle and placed within a patient's esophagus. The gastroscope may include a proximal part, a distal part, an ultrasound transducer located in the distal part of the gastroscope and configured to receive ultrasound imaging data, as well as a motor and a traction cable. In some cases, the traction cable is connected to the motor and the distal part of the gastroscope. The motor may be configured to receive an electrical signal from the handle to control movement of the distal portion of the gastroscope using a traction cable. In some embodiments, the gastroscope includes a force sensor configured to detect force applied to the distal portion of the gastroscope. The TEE probe may also include a force sensor controller coupled to a force sensor and a motor. The force sensor controller may be configured to control actuation of the traction cable by the motor based on the force measured by the force sensor. In other embodiments, the TEE probe includes a motor sensor coupled to the motor and configured to determine the position of the motor. In still other embodiments, the ultrasound transducer is an array of ultrasound transducers, wherein the gastroscope includes a microbeamformer that is coupled to the array of ultrasound transducers and is positioned distal to the gastroscope.

In accordance with yet another exemplary embodiment of the invention, a TEE probe is provided. The TEE probe contains a handle, a gastroscope connected to the handle, and a wireless communication module that is connected to the handle and the gastroscope. The gastroscope may be configured to be placed in a patient's esophagus and may include an ultrasound transducer located at the distal end of the gastroscope. The gastroscope may be configured to receive ultrasound imaging data. The wireless communication module may include a wireless communication element and a microcontroller connected to the wireless communication element. The wireless communication module may be configured to receive a command signal from a console located at a distance from the TEE probe and transmit ultrasound image data to the console. The microcontroller may be configured to transmit an electrical signal to the gastroscope to control the distal portion of the gastroscope in response to the received command signal.

In some embodiments, the TEE probe further comprises a user interface coupled to the handle and configured to receive manual input from a user to control the gastroscope. According to other embodiments, the microcontroller is configured to transmit an electrical signal to control the movement of the distal part of the gastroscope in response to a command signal. According to other embodiments, the gastroscope comprises a traction cable connected to the distal portion of the gastroscope and an actuator connected to the traction cable. The microcontroller may be configured to transmit an electrical signal to the actuator in order to actuate the traction cable to move the distal part of the gastroscope. In some embodiments, the microcontroller may be configured to transmit an electrical signal to control the ultrasonic transducer in response to a command signal. In other embodiments, the ultrasonic transducer is an array of ultrasonic transducers, wherein the handle includes a beamformer coupled to the array of ultrasonic transducers. The handle may also include a signal processor coupled to the beamformer. In some cases, the gastroscope includes a microbeamformer connected to an array of ultrasound transducers and to the beamformer. The TEE probe, in some cases, may further comprise a battery capable of powering the wireless communication module and the gastroscope.

In some embodiments, the TEE probe includes a handle interface located at the distal portion of the handle and a gastroscope interface located at the proximal portion of the gastroscope. The handle and the gastroscope can be releasably connected to each other via a handle interface and a gastroscope interface. The handle interface may be configured to transmit an electrical signal to the gastroscope via the gastroscope interface to control the distal end of the gastroscope. According to some embodiments, the wireless communication module is located within the handle. In other embodiments, the wireless communication module includes a housing connected to the handle such that when the wireless communication module is connected to the handle, the wireless communication module transmits an electrical signal to the gastroscope. In some embodiments, the body is removably connected to the handle by at least one of the following means: a USB interface or a spring pin interface.

According to an exemplary embodiment of the invention, a method is provided for wirelessly controlling a TEE probe. The method may include the steps of: using a wireless communication element connected to the handle of the TEE probe, wirelessly receiving a command signal transmitted by a console located at a distance from the TEE probe, while the gastroscope of the TEE probe is placed in the patient's esophagus; transmitting the received command signal via the wireless communication element to a controller connected to the handle; and in response to the received command signal, voltage is applied via the controller to the actuator connected to the gastroscope to control the movement of the distal part of the gastroscope inside the esophagus.

According to some embodiments, the method may further comprise: at a controller coupled to the handle, receiving a feedback signal from an actuator; and based on the feedback signal, by means of the executive body, the movement of the distal part of the gastroscope is corrected. In some aspects, the step of receiving a feedback signal from the actuator comprises receiving a force detection signal, and the step of correcting the movement of the distal portion of the gastroscope comprises stopping the movement of the distal portion of the gastroscope by the actuator. According to some embodiments, the method further comprises: wirelessly transmitting a feedback signal to the console via a wireless communication element; and, in response to the received feedback signal, activating a force detection indicator. The feedback signal may comprise a force detection signal. According to some embodiments, the method further comprises: using an ultrasound transducer located at the distal portion of the gastroscope, obtaining ultrasound imaging data; and wirelessly transmitting the ultrasound imaging data to the console via the wireless communication element. The method may further comprise the steps of: receiving ultrasound imaging obtained by the ultrasonic transducer on the beamformer; and transmitting the ultrasonic imaging data processed by the beamformer to the wireless communication element. According to some embodiments, the method further comprises: receiving ultrasound imaging data obtained from an ultrasound transducer on a microbeamformer; and transmitting the ultrasonic imaging data processed by the micro beamformer to the beamformer.

Additional aspects, features and advantages of the present invention will become apparent from the following detailed description.

Brief description of the drawings

Exemplary embodiments of the present invention will be described with reference to the accompanying drawings, of which:

fig. 1 is a side view of one embodiment of a transesophageal echocardiography (TEE) probe according to the state of the art;

fig. 2 is a schematic view of the TEE probe of FIG. 1 corresponding to the current state of the art;

fig. 3 is a perspective view of a modular ultrasound imaging device and ultrasound imaging system in accordance with an embodiment of the present invention;

fig. 4 is a diagram of a TEE probe system according to an embodiment of the present invention;

fig. 5A is a perspective view of the handle of a TEE probe according to an embodiment of the present invention;

fig. 5B is a perspective view and partly transparent view of the TEE probe handle of FIG. 5A corresponding to an embodiment of the present invention;

fig. 6A is a perspective view of the proximal portion of the gastroscope, the interface of the gastroscope, and the distal portion of the handle of a TEE probe according to an embodiment of the present invention, with the gastroscope and handle separated;

fig. 6B is a perspective view of the proximal gastroscope, handle interface, and distal handle of a TEE probe according to an embodiment of the present invention with the gastroscope and handle separated;

fig. 7 is a perspective view of the TEE probe of FIG. 6A and 6B when the gastroscope and handle are paired;

fig. 8 is a perspective view and partly transparent view of the proximal portion of a gastroscope and handle according to an embodiment of the present invention;

fig. 9A is a vertical and side view of the distal part of a TEE probe according to an embodiment of the present invention, showing the forward and backward bending of the distal part;

fig. 9B is a vertical and frontal view of the distal part of a TEE probe according to an embodiment of the present invention, showing the bending of the distal part in the left and right direction;

fig. 9C is a vertical and anterior view of the distal portion of the TEE probe of FIG. 9A illustrating the rotation of the distal portion counterclockwise, clockwise, as well as advancing and retracting the distal portion;

fig. 9D is a perspective view of the distal portion of the TEE probe of FIG. 9A showing angle increase and decrease in multiple planes for an ultrasonic transducer;

fig. 10 is a sectional view of the distal handle and proximal portion of a TEE gastroscope probe according to an embodiment of the present invention;

fig. 11 is a sectional view of the distal portion of a gastroscope TEE probe according to an embodiment of the present invention;

fig. 12 is a diagram of a TEE probe system according to an embodiment of the present invention;

fig. 13 is a diagram of a TEE probe system containing a microbeamformer according to another embodiment of the present invention;

fig. 14 is a perspective view of the proximal handle of a TEE probe incorporating a console interface and in accordance with an embodiment of the present invention;

fig. 15 is a perspective view and partly transparent view of the wireless communication module of a TEE probe according to an embodiment of the present invention;

fig. 16 is a diagram of a TEE probe system incorporating a wireless communication module according to an embodiment of the present invention;

fig. 17 is a system diagram of a TEE probe including a wireless communication module according to another embodiment of the present invention;

fig. 18 is a flow chart of a method for remotely controlling a transesophageal echocardiography procedure according to an embodiment of the present invention;

fig. 19 is a flowchart of a method for capturing and wirelessly transmitting an ultrasound image to a console.

Implementation of the invention

For the purposes of facilitating understanding of the principles of the present invention, this description will be linked to the embodiments that are illustrated by the drawings, and specific language will be used to describe the drawings. However, it should be understood that the embodiments are not intended to limit the scope of the invention in any way. Any changes and further modification of the described devices, systems and methods, as well as any additional application of the principles of the present invention, as a person skilled in the art to which the present invention relates, is fully contemplated and included in the present invention. In particular, it is fully contemplated that functions, components and/or steps described in relation to one embodiment may be combined with functions, components and/or steps described in relation to other embodiments of the present invention. However, for the sake of brevity, multiple repetitions of these combinations will not be described individually.

In FIG. 1 and 2 depict a conventional TEE probe 10 comprising a gastroscope 30, a handle 20, and a cantilever interface cable 70. In this embodiment, the gastroscope 30, handle 20, and cantilever interface cable 70 are connected to each other in a non-separable manner. The handle 20 is permanently connected to the gastroscope via a non-removable connection 55, and to the cantilever interface cable 70 via a non-removable connection 75. In other words, in the design of the TEE probe 10 of FIG. 1 and 2, the gastroscope 30 and console interface cable 70 are not separated from the handle 20 and reattached. In some embodiments, a conventional TEE probe 10 may be a single assembly in which the gastroscope 30 and cantilever interface cable 70 are permanently attached to the handle 20 at permanent connections 55, 75 by means of adhesives, screws, or other means of attachment that cannot be easily disconnected by a physician or user.

The term "non-separable" can broadly refer to a connection or attachment method that is not designed to be regularly disconnected and reconnected. Thus, although the two connected elements may be physically disconnected, the present description may refer to the connection or fastening as non-separable when the separation of these elements is not performed during normal medical use of the device. The terms "connection, connected, connected, or connected to" are used to refer in a broad sense to any combination, fastening or connection. In the present description, reference may be made to the two elements as connected even when they are permanently attached to each other or are entirely made as a single unit. The term "connected" in the sense in which it is used in the present description, includes types of direct or indirect connection or fastening, as well as types of detachable connection or fastening. Two elements may be said to be connected to each other even if they are not in direct contact with each other, or there are two or more connecting elements between said elements. The terms "removable or detachable" may be used to refer to a method of attachment or attachment that is capable of being detached and reattached during normal use of the device or system, such as before, during, and after a medical procedure.

The gastroscope 30 includes an elongated body 37, a distal portion 39, and a proximal portion 32. The elongated body 37 may be flexible so that it can be guided through a patient's esophagus. The gastroscope 30 includes first and second traction cables 31, 33, which are mechanically connected to the first and second movement control elements 23, 25, which are connected to the handle 20. Such a design may allow the physician to control the movement of the distal part of the gastroscope. Controlling the movement of the distal portion 39 of the gastroscope 30 can assist the physician in directing the gastroscope 30 in the patient's body to the desired imaging site. The rigid or fixed design of the gastroscope could injure the patient, and could be unsuitable for ultrasound imaging, requiring precise positioning and sufficient contact with the patient's tissues to obtain ultrasound images. Thus, the traction cables 31, 33 and the flexible members assist the physician in obtaining ultrasound images of the patient's organs. Due to the fact that the first and second traction cables 31, 33 are mechanically connected to the first and second motion control elements 23, 25, the doctor, by manipulating the first and second motion control elements 23, 25, can receive tactile feedback from the distal end 39 of the gastroscope 30, when the distal end 39 is pressed against the walls of the esophagus.

Because conventional TEE probe designs manipulate traction cables that run from the end of the gastroscope to the motion controls located on the handle, gastroscopes cannot be separated or detached from the handle during normal use. Thus, in typical designs, gastroscopes are attached to the handle in a non-separable manner. However, such designs may have disadvantages such as those discussed above, such as unnecessary redundancy of TEE probes, and costly and risky cleaning procedures.

In FIG. 3 depicts an ultrasound device 110 of an ultrasound imaging system 100 in accordance with one embodiment of the present invention. According to the depicted design, the ultrasound imaging system includes a TEE probe 110. In this embodiment, the gastroscope 130, comprising a proximal portion 132 and a distal portion 139, is shown detached from the handle 120. The gastroscope 130 includes a gastroscope tip 140 on its distal portion 139. The gastroscope 130 on its proximal part 132 contains the interface 160 pairing of the gastroscope, and the handle 120 on its distal part 129 contains the interface 150 pairing of the handle. The gastroscope 130 and the handle 120 may be releasably connected to each other via the handle interface 150 and the gastroscope interface 160. In some embodiments, gastroscope 130 and handle 120 are connected to each other in a releasable manner such that a user can control movement of the distal portion 139 of gastroscope 130 via one or more controls located on the handle such that ultrasound imaging data and/or data controls may be passed from the ultrasonic transducer of the gastroscope 130 through the gastroscope interface 160 and the handle interface 150 to the console. In some embodiments, the gastroscope tip 140 includes an imaging element configured to acquire imaging data coupled to the anatomical structure of a patient within which the gastroscope 130 is located. Fig. 11) configured to obtain ultrasound imaging data. For example, the imaging element may be an array of ultrasonic transducers containing one or more ultrasonic transducer elements. For example, according to some embodiments of the invention, the matrix of ultrasonic transducers may contain from 2 to 1100 ultrasonic transducer elements. In some embodiments, the ultrasonic transducer array comprises 64, 128, 512, or 1024 ultrasonic transducer elements, or any other suitable number of ultrasonic transducer elements, whether greater than or less than indicated.

As used in this or other embodiments, the term "handle" may refer to a structure capable of being gripped, manipulated, or manually operated by a clinician. As will be discussed in more detail below, the handle may also be configured to perform various functions and operations, and may contain electronic components. For example, manipulation of the distal portion 139 of the gastroscope 130 may involve manipulation of a disc or other control of the handle 120, which may cause retraction or release of one or more traction cables 131, 133 connected to the distal portion of the gastroscope. For example, by retracting or releasing one or more traction cables, the posterior/anterior flexure and the right/left flexure of the distal portion of the gastroscope can be controlled. Thus, although the handle 120 shown in FIG. 3 includes a housing or casing designed to be gripped or manipulated by a clinician, in the present invention, the term "handle" refers in a broad sense to a part of the TEE probe system, which may contain various elements, such as electronics.

Although the ultrasonic device 110, as discussed in FIG. 3 and other figures of the present invention is a TEE probe, the present invention provides, within its scope, various ultrasound imaging devices and systems capable of obtaining ultrasound images of various parts of a patient's body. Accordingly, the ultrasound device 110 may be any type of imaging system suitable for use in various cavities within a patient's body. According to some embodiments of the invention, the ultrasound device 110 may include systems capable of performing intravascular ultrasound (IVUS, Intravascular UltraSound), intravascular ultrasound of the front view (FL-IVUS, Forward Looking Intravascular UltraSound), intravascular photoacoustic studies (IVPA , Intravascular PhotoAcoustic), intracardiac echocardiography (ICE, Intracardiac Echocardiography) and/or other suitable imaging modalities.

It should be understood that the ultrasound device 110 may be configured to acquire any suitable intracavitary imaging data. In some embodiments, device 110 may include any suitable variety of imaging element, such as optical imaging, optical coherence tomography (OCT, Optical Coherence Tomography), and the like. In some embodiments, the device 110 may be configured to acquire any suitable intracavitary data using a pressure sensor, a flow sensor, a temperature sensor, an optical fiber, a reflector, a mirror, a prism, an ablation element, an RF electrode, a conductor, and/or a combination of these elements. . In general, device 110 may include an electronic, mechanical, optical, and/or acoustic sensor to obtain intracavitary data associated with a cavity in a patient's body. Device 110 may be sized, shaped, constructed and/or configured to be suitable for insertion into a patient's body cavity.

In some illustrated embodiments, the ultrasound device 110 is a TEE probe. In some embodiments, the ultrasound device is a catheter, guiding catheter, or guidewire. Ultrasonic device 110 may include a flexible elongate 137. As used in the present invention, the elongate or flexible elongate is at least any thin, long, flexible structure that is structurally calculated (e.g., sized and /or form) for placement in the anatomical cavity. For example, the distal portion 139 of the flexible elongate 137 may be placed within the lumen of the cavity, while the proximal portion 132 of the flexible elongate 137 may be placed outside the patient's body. Flexible elongated element 137 may have a longitudinal axis. In some cases, the longitudinal axis may be the central longitudinal axis of the flexible elongate member 137. In some embodiments, the flexible elongate member 137 may include one or more polymer/plastic layers made from various grades of nylon, pebax, polymer composites, polyimides, and/ or teflon. In some embodiments, the flexible elongated member 137 may include one or more layers of woven metal and/or polymer filaments. The woven layer or woven layers may be woven tightly or loosely in any suitable configuration, including any suitable number of weaves per unit length. According to some embodiments, the flexible elongate element 137 may include one or more metal and/or polymer coils. All or part of the flexible elongate 137 may have a cross section of any suitable geometry (eg, round, oval, rectangular, square, elliptical, etc.) or a cross section that does not correspond to a specific geometric shape. For example, the flexible elongate 137 may have a generally cylindrical profile with a circular cross section that defines the outer diameter of the flexible elongate 137. For example, the outer diameter of the flexible elongate 137 may have any suitable value for its placement within the anatomical cavity 102, including values in the range of approximately 0.3 mm to 26.7 mm, e.g. 1.0 mm, 2.3 mm, 2.7 mm, 3.0 mm, 8.3 mm, 10.0 mm, 11.3 mm , 17.0 mm, 20.0 mm and/or other suitable values, both larger and smaller.

The ultrasonic device 110 may or may not contain one or more gaps (channels) extending along the entire length (or along a part of the length of the flexible elongated element 137. Such a gap in the ultrasonic device 110 may be structurally provided (i.e., may can be sized and/or shaped) to accommodate and/or guide one or more diagnostic and/or therapeutic instruments. embodiments, the ultrasound device 110 may be used in conjunction with a guidewire.In general, a guidewire is a thin, long, and flexible structure that is designed (i.e., sized and/or shaped) for placement in an anatomical cavity. During a diagnostic and/or therapeutic procedure, the practitioner typically first inserts the guidewire into the anatomical cavity and moves the guidewire to the desired location in the anatomical cavity, such as a point adjacent to an intravascular occlusion. The guidewire facilitates insertion and positioning of one or more other diagnostic and/or therapeutic tools, including the ultrasound device 110, at a desired location in the body. For example, the ultrasound device 110 is moved through the anatomical cavity on a guidewire. In some embodiments, the lumen of the ultrasonic device 110 may follow the entire length of the flexible elongated member 137. In some embodiments, the ultrasonic device is not used in conjunction with a guidewire, and the exit/entry port may be omitted from the ultrasonic device 110.

Anatomy can be represented by any structures that are filled with or surrounded by fluids - both natural and artificial structures. For example, a certain anatomical structure may be within the patient's body. Fluid can flow through the anatomical cavity. In some cases, the ultrasound device 110 may be referred to as a transesophageal device. The anatomical structure can be the oral cavity, pharynx, esophagus and/or stomach of the patient. In some cases, the ultrasound device 110 may be referred to as an intracardiac or intravascular device. In various embodiments, such an anatomical structure is an artery or vein of the patient's vasculature, including the coronary vessels of the heart, the peripheral vasculature, the vessels of the nervous system, the renal vasculature, and/or any other anatomical structure/cavity within the body. In some cases, the anatomical structure may be tortuous. For example, device 110 can be used to examine any number of body sites and tissue types, including but not limited to other possible organs such as the liver, heart, kidneys, gallbladder, pancreas, lungs, esophagus; ducts; intestines; structures of the nervous system, including the brain, dural sac, spinal cord, and peripheral nerves; urinary tract; as well as valves within the blood volume, chambers or other parts of the heart, and/or other body systems. In addition to natural structures, device 110 can be used to examine artificial structures such as heart valves, stents, shunts, filters, and other devices.

In FIG. 4 is a diagram of an ultrasound imaging system 100 according to an embodiment of the present invention. In some embodiments, the ultrasound imaging system is a transesophageal echocardiographic imaging system. According to the embodiment shown in FIG. 4, gastroscope 130 is connected to handle 120 via probe interface 155, and handle 120 is connected to console 180 via console interface 175. The probe interface 155 may be a combination of a gastroscope interface and a handle interface, while the console interface 175 may include a console interface cable and console connection connector as described in FIG. 3. The gastroscope 130 can receive ultrasound imaging data, transmit the ultrasound imaging data to the handle 120 via the probe interface 155, and the handle 120 can transmit the ultrasound imaging data to the console 180 via the console interface 175. In addition, gastroscope 130 may receive control data from console 180 through handle 120 to control various aspects of the TEE scan, such as data from one or more ultrasound transducer array firing sequences, as well as control data for movement or angulation of the distal portion 139 of gastroscope 130.

In some embodiments, gastroscope 130 transmits ultrasound imaging data to console 180 via handle 120. In some embodiments, console interface 175 may be located at the proximal portion of handle 120, such as at the proximal end of handle 120. In some embodiments, interface 175 The console can be at least one of the following interfaces: a USB interface or a spring-pin interface. In other embodiments, the console interface 175 may be a cable rigidly attached to the handle 120. As will be discussed in more detail below, in some embodiments, the handle 120 includes electronic components for modulating or processing the ultrasound imaging data transmitted to the console 180.

In FIG. 5A and 5B show the handle 120 of the TEE probe 110 according to an embodiment of the present invention. The handle shown in Fig. 5A and 5B may contain similar or identical components as the handle of FIG. 3, such as the proximal portion 122, the distal portion 129, and the interface 150 of the interface. Interface 150 may be a spring-loaded pin interface comprising an array of spring-loaded pins and a latch 127 removably coupled to the gastroscope 130 of FIG. 3. The handle 120 may also include one or more user command selectors 125 configured to receive a user command and transmit a user command signal. In various embodiments, the implementation of the handle 120 may contain one, two, three, four or more selectors 125 user commands. For example, the user's command may be to press a button. A button press can be converted into a signal to start an ultrasound scan protocol or to control the movement of the gastroscope 130. In other embodiments, the user command selectors 125 can be electronic buttons, dials, capacitive sensors, levers, toggle switches, knobs, joysticks, etc. P.

In FIG. 5B is a partially transparent view of the handle 120 of FIG. 5A. The handle 120 may include various electronic devices configured to control one or more aspects of obtaining a transesophageal echocardiogram. Handle 120 of FIG. 5B includes a microcontroller 121 connected to a console interface 175 in the proximal portion 122 of the handle 120, to a handle interface 150 in the distal portion 129 of the handle 120, and to user command selectors 125. The microcontroller 121 may receive an electrical signal, such as a command signal, from the console via the console interface 175, from the user's command selectors 125, or signals from both. The microcontroller 121 can receive and transmit an electrical signal to the appropriate components of the TEE probe 110, such as the gastroscope 130. The handle 120 also includes a power source 123 configured to provide power to the various elements of the TEE probe 110. In the embodiment of FIG. 5B, the handle 120 includes a beamformer 128, a scan controller 126, and a signal processor 124 in the distal portion 129 of the handle 120. The beamformer 128 may be configured to receive ultrasound imaging data from an ultrasound transducer, and process the ultrasound imaging data to construct an ultrasound image. The signal processor 124 may be configured to further process the ultrasound imaging data to be displayed to a clinician. The scan controller 126 can control various aspects of the ultrasound imaging procedure performed by the ultrasound transducer, such as frequency, pulse amplitude, pulse transmission time, echo reception time, scan line progression, and the like.

Although beamformer 128, signal processor 124, and scan controller 126 in the embodiment shown in FIG. 5B are located in the distal portion 129 of the handle 120, it is possible, without departing from the scope of the present invention, to place any of the following devices: a beamformer 128, a signal processor 124, or a scan controller 126 in other areas of the TEE probe 110, such as a gastroscope 130 or the proximal portion of the handle 120. In some embodiments, one or more of these components may be part of an external console (eg, console 180 of FIG. 4). According to other embodiments, the handle 120 may be connected to a console interface cable. And in other embodiments, the console interface cable may be permanently attached to the handle 120, or integral with the handle 120. or more electrical components of the TEE probe, such as microcontroller 121, scan controller 126, and gastroscope 130.

In FIG. 6A and 6B are perspective views of the interface 160 of the gastroscope 130 and the interface 150 of the handle 120 of the TEE probe 110, in accordance with one embodiment of the present invention. As shown in FIG. 6A, the gastroscope interface 160 may be located on the proximal portion 132 (at the proximal end) of the gastroscope 130, and may include an array of female spring connectors 162. The female spring connectors 162 may correspond to the array of spring pins 152 of the handle interface 150 as shown in FIG. 6B. When the gastroscope is connected to the handle, electrical signals can be provided from the gastroscope 130 to the electrical components of the handle 120 and vice versa through the handle interface 150 and the gastroscope interface 160.

In the present description, the term "transmission" may refer to a situation where an electrical component directs, sends along a certain route, or allows the passage of a certain electrical signal to another component of the device. For example, an electrical wire may transmit an electrical signal even though the electrical wire does not contain electronics that can execute commands or selectively route an electrical signal to various electrical components.

Although the gastroscope interface 160 and the handle interface 150 of the embodiment shown in FIG. 6A and 6B include spring-loaded pin interfaces 162, 152, the present invention contemplates any releasable interface that allows communication between the gastroscope 130 and the handle 120 or console 180. For example, in some embodiments, the gastroscope interface 160 and interface 150 The handle interfaces are a USB interface. In other embodiments, the gastroscope interface 160 and the handle interface 150 are unbalanced electrical connectors, plug/socket connectors, or any other suitable interface.

In FIG. 7 shows a handle 120 and a gastroscope 130 corresponding to FIG. 6A and 6B in the coupled state. With this configuration, the gastroscope interface 160 is connected to the handle interface 150 so that the gastroscope 130 is fixed to the handle 120 and electrical signals are allowed to pass between the gastroscope 130 and the handle 120. The electrical signals passing between the handle 120 and the gastroscope 130 may include includes instructions for controlling the movement of the gastroscope 130 in the patient's body, ultrasound imaging data, and other signals. The connection of the handle 120 to the gastroscope 130 may include a physical connection via a latch, such as the latch 127 shown in FIG. 5A, or any other method of fixing detachable components, such as a magnetic connection, or through a traditional electrical connection, such as a USB interface, a plug connector (plug/socket type), etc. TEE probes containing removable or modular components can eliminate some of the equipment redundancy that is required with conventional TEE probes that are a single unit. For example, the TEE probe 110 according to an embodiment of the present invention may allow a physician to attach one of a number of gastroscopes 130 to the handle 120 of the TEE probe 110. diameter and/or length), as well as the different types of imaging that the clinician wants to perform. Since the same handle can be connected to different gastroscopes 130, it is not necessary for the clinician to have a separate complete TEE probe for each gastroscope, containing a handle and a console interface cable. In addition, TEE probes 110 containing removable components may have advantages in terms of device cleaning. Components that require one type of cleaning process, such as the gastroscope 130, can be cleaned separately from other components that do not require the same type of cleaning. For example, the handle 120, which may be damaged by the cleaning process designed for the gastroscope 130, can be cleaned using a process that is more appropriate to its design and components.

In FIG. 8 is a partially transparent view of the TEE probe 110 of FIG. 3 when the gastroscope 130 is separated from the handle 120. The gastroscope 130 includes a motor 135, which is connected to the first traction cable 131 and the second traction cable 133, is configured to drive said cables. Each of the cables - the first traction cable 131 and the second traction cable 133 - may contain a number of individual cables or threads. The first and second traction cables 131, 133 can be connected to various points on the distal portion 139 of the gastroscope 130 so that when the motor 135 drives or retracts the first and/or second traction cables 131, 133, the motor can control the movement of the distal portion 139 gastroscope 130 in different directions. For example, as shown in FIG. 9A, retracting and releasing the first traction cable 131 can bend the distal portion 139 of the gastroscope 130 in a back and forth direction, while retracting and releasing the second traction cable 133 can bend the distal portion 139 of the gastroscope 130 in a right and left direction.

Placing the motor 135 within the gastroscope 130 allows for a less complex interface or less complex communication between the gastroscope 130 and the handle 120 while maintaining the functionality and maneuverability of the gastroscope 130. Referring back to FIG. 1 and 2, in a conventional TEE probe 10, the motion control elements 23, 25 for actuating the traction cables 31, 33 could be placed in the handle 20, which requires that the traction cables 31, 33 extend from the distal end of the gastroscope 30. to the handles 23, 25 in the handle 20. Such a scheme did not allow the implementation of a modular design, as in FIG. 8, in which the clinician may disconnect the gastroscope 130 from the handle 120 and reattach to the handle 120 while maintaining control of the distal portion 139 of the gastroscope 130 when the gastroscope 130 is connected to the handle 120.

The gastroscope handpiece 140 includes a handpiece body 141 housing an ultrasound transducer 142, as well as ultrasound transducer connecting wires 143 connected to the ultrasound transducer 142 for transmitting ultrasound imaging data to the handle 120. The gastroscope 130 also includes a first pull cable 131 and a second pull cable 133 which are connected to the distal portion 139 of the gastroscope 130 and extend between the handle 120 and said distal portion 139.

The first and second traction cables 31, 33 are connected to the first motion control element 23 and the second motion control element 25, respectively. The first and second control elements 23, 25 are connected to the handle 20, and correspond to the direction of movement or degree of freedom of the distal portion 39 of the gastroscope 30. how the second motion control element 25 can correspond to the curvature of the distal portion 39 of the gastroscope 30 in the right and left directions. Thus, by manipulating the first and second motion controls 23, 25, the user can control the movement and orientation of the distal portion 39 of the gastroscope 30 within the patient's esophagus.

Although the gastroscope 130 shown in FIG. 8 includes a motor 135 for controlling the movement of the first and second traction cables 131, 133, the gastroscope 130 may include other mechanisms and actuators for controlling the movement of the distal portion 139 of the gastroscope. Furthermore, although the gastroscope 130 shown in FIG. 8 includes first and second traction cables 131, 133, gastroscope 130 may include additional traction cables, such as a third and fourth traction cable. As discussed above, each traction cable may comprise a number of individual cables or threads for controlling the movement of the distal portion 139 of the gastroscope 130.

Fig. 9A-9D depict the distal portion 139 of the gastroscope 130 in various modes of motion and flexion. Fig. 9A is a side view of the distal portion 139 of the gastroscope 130 in various posterior and anterior bending modes. Fig. 9B is a front view of the distal portion 139 of the gastroscope 130 in various right and left bending modes. Forward/backward and right/left bending may be accomplished by retracting and releasing (release) one or more traction cables corresponding to one or more driving modes. As mentioned above, the clinician can control the bending of the distal portion 139 of the gastroscope 130 in the forward or backward direction by retracting or releasing the first traction cable 131. may consist in cleaning one of the individual cables of the first traction cable 131, while the other of the individual cables of the first traction cable 131 may remain stationary.

Fig. 9C-9D depict additional modes of movement of the distal portion 139 of the gastroscope 130 and the ultrasound transducer 142. FIG. 9C depicts modes of physical motion, including retract, forward, and rotation, that can be obtained by manually manipulating the gastroscope 130, such as rotating a handle to rotate the gastroscope 130 in the patient's esophagus. The physician may also advance or retract the distal portion 139 of the gastroscope 130 in the patient's esophagus by advancing the handle toward the patient's esophagus or retracting the handle away from the patient's esophagus. Fig. 9D depicts the electronic deflection or angle changing modes coupled to ultrasonic energy output by transducer 142. The changing modes depicted in FIG. 9D may not require physical manipulation of the distal end of the gastroscope, such as the modes of motion shown in FIG. 9A-9D. The electronic modes of FIG. 9D may be implemented by controlling one or more electronic aspects of the array of ultrasonic transducers, such as the timing of the drive and receive signal sequences.

According to FIG. 9A-9D, the depicted various modes of motion and flexion of the distal portion 139 of the gastroscope 130 may be controlled by one or more user command selectors located on the handle (eg, 125a, 125b of FIG. 8.). For example, in one embodiment, the forward and backward bending of the distal portion 139 of the gastroscope 130 is controlled by the first command selector 125a, while the left and right bending is controlled by the second command selector 125b. The rotation, advance, and retraction of the distal portion 139 can be controlled by manually rotating, advancing, and retracting the handle 120 of the TEE probe 110. Electronic deflection setting and electronic deflection or radiation angle manipulation may be performed via a third user command selector. As discussed above, each command selector 125a, 125b may be one of the following: an electronic button, a dial, a capacitive sensor, a lever, a toggle switch, a knob, a joystick, and the like. According to one embodiment, when the physician presses the electronic button of the first command selector 125a, the handle 120 receives the user's command signal from the selector 125a, and transmits this control signal to the gastroscope 130 via the handle interface 150 and the gastroscope interface 160 to control the angulation of the distal portion 139 gastroscope 130 in the direction back and forth.

In FIG. 10 shows a sectional view of the distal portion 129 of the handle 120 and the proximal portion 132 of the gastroscope 130 of the TEE probe 110 of FIG. 3. The proximal portion 132 of the gastroscope 130 includes a force sensor controller 138 and a motor controller 134 coupled to a motor 135. The force sensor controller 138 may be coupled to a force sensor 145 (shown in FIG. 11), and configured to receive a force sensor signal, and performing an operation based on said force sensor signal.

For example, when a force is applied to the distal portion 139 of the gastroscope 130, the force sensor controller 138 may receive a signal containing the detected force amount from the force sensor 145 and compare the detected force amount with a predetermined threshold. If the amount of detected force exceeds a predetermined threshold, then the force sensor controller 138 may send instructions to the motor controller 134 to reduce the rotation speed or stop the rotation of the motor, or to reverse the rotation of the motor to reverse the movement of the distal portion 139 of the gastroscope 130 in order to reduce or eliminate the force, attached from the distal part 139 of the gastroscope 130 to the patient's esophagus. Such a construction may enable the clinician to control the movement of the distal portion 139 of the gastroscope 130 without exerting force beyond a safe limit. Excessive force applied to the wall of the esophagus could injure the patient.

The gastroscope shown in Fig. 10 further includes ultrasonic transducer connecting wires 143 connected to the ultrasonic transducer 142 and the gastroscope interface 160. The ultrasound transducer connecting wires 143 may transmit ultrasound imaging data from the ultrasound transducer 142 to the gastroscope interface 160 for further transmission to the handle 120 and/or to the console. The gastroscope 130 also includes force sensor connecting wires 146 extending between the force sensor controller 138 and the force sensor 145 itself. The force sensor connecting wires 146 may be configured to transmit force sensor data to the force sensor controller 138 . In other embodiments, the force sensor connecting wires 146 may be connected to a motor controller 134, wherein the motor controller 134 is configured to receive a detected force signal from the force sensor 145 in order to control the distal portion 139 of the gastroscope 130.

In FIG. 11 is a sectional view of the distal portion 139 of the gastroscope 130 shown in FIG. 3. In this embodiment, the distal portion 139 of the gastroscope 130 includes a gastroscope tip 140 located near the distal end or at the distal end of the gastroscope 130. The gastroscope tip 140 includes a tip body 141 forming the outer portion of the tip. The gastroscope tip 140 also includes an ultrasonic transducer 142, which may be an array of ultrasonic transducers, and a force sensor 145 coupled to the tip body 141 and configured to sense the force applied to the gastroscope tip 140 and/or the distal portion 139 of the gastroscope 130. The force sensor 145 may include a flexible base located around the distal portion 139 of the gastroscope 130, or a force sensor with flexible electronics. The tip 140 of the gastroscope also contains a microformer 144 beam connected to the matrix 142 of the ultrasound transducers. Microbeamformer 144 may be configured to process or modify electrical signals from an array of ultrasound transducers for use in ultrasound imaging. The microbeamformer 144 may also be used in combination with an appropriate beamformer (128 of FIG. 5B) in the handle 120. In this configuration, the microbeamformer 144 may eliminate some of the redundancy and connecting wires required to transfer raw ultrasound imaging data from the ultrasound transducer 142 to the console. . The use of a microbeamer 144 in the gastroscope 130 can also help reduce the complexity of the gastroscope interface 160 and handle interface 150, for example, by reducing the number of spring-loaded pins 152, 162 needed to transmit ultrasound imaging data.

Although some embodiments of the invention contemplate the use of a microbeamformer 144 in combination with a beamformer (128 of FIG. 5B) in a handle 120, the scope of the present invention permits the construction of a gastroscope 130 having a beamformer located within the gastroscope 130. Thus, all beamforming ( pattern) may take place within the gastroscope 130, or, in other embodiments, the task of beamforming may be shared between the microbeamformer of the gastroscope 130 and the beamformer of the arm 120. In some embodiments, all beamforming may take place in the arm 120. In other embodiments, gastroscope 130 may not include a microbeamformer.

In FIG. 12 is a diagram of a TEE imaging system 100 in accordance with one embodiment of the present invention. The TEE imaging system 100 corresponding to FIG. 12 may contain components that are similar or identical to those of the embodiments shown in FIG. 3-11. As shown in FIG. 12, the TEE imaging system 100 may include a gastroscope 130 including a handpiece body 141, a motor 135, traction cables 131, 133, an ultrasound transducer 142, a force sensor 145, and a temperature sensor 148. These components may be arranged similarly to the configurations shown in FIG. 3-11, or may have a slightly different configuration.

As shown in FIG. 12, the microcontroller 121 receives and transmits a plurality of electrical signals to perform a plurality of functions. Microcontroller 121 may receive commands from console 180 or from user command selectors such as buttons 125 connected to handle 120. Microcontroller 121 may then process and translate said commands to appropriate components such as power supply 123, scan controller 126, and motor 135. Microcontroller 121 may also receive signals from a variety of components such as force sensor 145, motor 135, and signal processor 124. Signals received by microcontroller 121 may contain information such as force data, temperature data, or motor position data that can be processed microcontroller 121 and used as feedback to control and adjust the various components of the TEE imaging system 100.

For example, the scan controller 126 may receive a command signal from the microcontroller 121 to start executing the scan sequence, as well as control data and timing signals related to the scan sequence to be executed. Scan controller 126 may provide control data and timing signals to beamformer 128 and signal processor 124 to control various aspects of ultrasound imaging. The beamformer 128 may transmit one or more excitation signals to the ultrasound transducer 142 causing the ultrasound transducer 142 to radiate ultrasonic energy in the form of ultrasonic waves into the patient's anatomy. Said one or more excitation signals may also comprise a command signal for measuring or recording echoes from the transmitted ultrasonic waves. The ultrasonic transducer 142 may then measure the echoes and convert the ultrasonic echoes into electrical signals containing ultrasound imaging data to be transmitted to the beamformer 128 . The beamformer 128 may then process, modulate, or beamform the ultrasound image data based on the criteria from the scan controller 126, and pass the ultrasound image data corresponding to the beamformed to the signal processor 124 for further processing of the ultrasound image data. The signal processor 124 may then send the processed ultrasound image data to the microcontroller 121. Upon receipt of the processed ultrasound image data from the signal processor 124, the microcontroller 121 may send the processed ultrasound image data to the console 180 via the console interface.

In another example, microcontroller 121 sends a power control signal to power supply 123 to apply voltage or current to motor 135 to control the operation or output of motor 135. Motor 135 may be connected to one or more traction cables 131, 133, which may be connected to the body 141 of the gastroscope tip. As the motor 135 rotates to actuate the traction cables 131, 133, the force sensor 145 can detect a force applied to a part of the gastroscope, such as the handpiece body 141, convert the detected force into an electrical signal, and transmit this electrical signal to the sensor controller 138 efforts. The electrical signal from the force sensor 145 may comprise force data, such as the force applied to the force sensor 145 and/or the handpiece body 141. The force sensor controller 138 may perform a number of functions, including comparing the force value data with a threshold value, as well as transmitting at least one command signal and the measured force value to the microcontroller 121.

In some embodiments, when force sensor controller 138 receives a measured force signal from force sensor 145 indicating that the force applied to force sensor 145 exceeds a threshold, controller 138 sends a command signal to microcontroller 121 to adjust the voltage or current. supplied to motor 135 to control the output of motor 135. In other embodiments, microcontroller 121 receives force data from force sensor controller 138, compares the measured force to a threshold, and sends an instruction to power supply 123 to correct the voltage or current applied to the motor 135 to control the output of motor 135. In still other embodiments, if force sensor 145 detects a force in excess of a predetermined threshold, then force sensor controller 138 may send an electrical signal directly to motor 135 to control the output of motor 135. In other embodiments, the microcontroller 121 may instruct the power supply 123 to stop powering the motor 135 so that the motor 135 stops moving the distal portion 139 of the gastroscope 130, or may instruct the motor 135 to reverse the direction of rotation of the motor 135 to return the distal portion 139 of the gastroscope 130 to its original position. The motor 135 may also transmit motor position data to the microcontroller 121 to enable the clinician or user to proactively control the movement of the distal portion 139 of the gastroscope 130.

In FIG. 13 is a diagram of a TEE probe system in accordance with another embodiment of the present invention. In FIG. 13 shows components similar to those of the embodiment shown in FIG. 12 and further shows a microbeamformer 144 located within the gastroscope handpiece housing 141 and connected to a scan controller 126, beamformer 128, and ultrasound transducer 142. In other words, the operation of the TEE probe of FIG. 13 may be similar to the operation of the TEE probe of FIG. 12 with the addition of a microbeam former 144. The microbeamformer shown in Fig. 13 may be configured to process or modify the raw ultrasound image data acquired and transmitted by the ultrasound transducer 142. As discussed above with respect to FIG. 11, the microbeamformer 144 can operate to reduce the amount of data transmitted to the handle via the gastroscope interface 160 and the handle interface 150. The microbeamformer 144 may also receive control data, such as timing signals, from the scan controller 126 to control the ultrasound transducer 142. The beamformer 128 of the handle 120 may perform additional processing on the ultrasound imaging data passed through the microformer to prepare said data for display to the clinician.

In accordance with another aspect of the present invention, FIG. 14 shows the proximal portion 122 of the handle 120 of the TEE probe 110 in accordance with one embodiment of the present invention. The proximal portion 122 includes a console interface 111 located at the proximal end of the handle 120 for transmitting data to the console. The console interface 111 includes a spring pin interface 114 which is an array of spring connectors. The console interface also includes a guide slot 116 for guiding the mating connector into place. The spring pin interface 114 may allow for detachable connection or attachment of the handle 120 and the console interface cable. Although the embodiment of FIG. 14 is a spring pin interface 114, the handle 120 may include other interfaces or means of connection to the console, such as a USB interface, a plug connector, and the like. A detachable USB cable, for example, may extend between the handle 120 and the console, and allow a releasable or separable connection of the cable to the handle 120, as opposed to a non-removable cable, as in some embodiments of conventional TEE probes. As will be discussed below with reference to FIG. 15, the console interface may be configured to connect to the wireless communication module. In other embodiments, the console interface may be configured to connect to a charger cable to receive power.

In FIG. 15 depicts a wireless communication module 190 coupled to the handle of a TEE probe and in accordance with one embodiment of the present invention. The wireless communication module 190 may include a housing 197 and a first module interface 195a for communicating the console with the handle. In other embodiments, the wireless communication module 190 may be located within the handle, or may be integrally attached to the handle 120.

In addition to the housing 197 and the first module interface 195a, the wireless communication module of FIG. 15 includes a radio module 191, a microcontroller 192, a battery 193, a power manager 199, a wireless element containing an antenna 194, and a second module interface 195b. The wireless communication module 190 may be connected to the handle via the first module interface 195a. In some embodiments, the first module interface 195a is a spring-loaded pin interface for communicating with the arm console interface. In other embodiments, the first module interface 195a may be a USB interface, or other suitable means of communication with the handle.

The radio module 191 may be coupled to the antenna 194 and configured to receive a radio signal from the console. In some embodiments, the radio signal may include commands or instructions from the console to perform one or more functions, such as a TEE scan. The radio module 191 may also be connected to the microcontroller 192 to transmit commands or instructions to the various components of the handle 120 and/or the gastroscope 130 via a console interface. For example, in some embodiments, radio module 191 may receive instructions from console 180 to control movement of distal portion 139 of gastroscope 130. Wireless module 190 may transmit instructions to a controller in handle 120. The controller may then instruct power manager 199 to apply power (e.g., , voltage or current) into the motor in the gastroscope or in the handle to actuate a traction cable designed to control the movement of the distal part of the gastroscope. In some embodiments, microcontroller 192 may communicate instructions directly to one or more components of the gastroscope, such as a motor or motor controller. According to some embodiments, the wireless module 190 may also include a user interface 198 and an audible indicator 196 configured to indicate the status or function of the wireless module 190. For example, in some embodiments, the audible indicator may include a speaker, and may emit an audible noise, such as a beep, to indicate that the wireless module 190 is properly attached to the handle.

Various components of wireless communication module 190 may be powered by battery 193. Battery 193 may be connected to a power manager 199 configured to distribute power from battery 193 to other components of wireless communication module 190. In some embodiments, battery 193 of wireless communication module 190 may also power various electrical components of the handle and/or gastroscope. For example, the gastroscope motor can be powered by the battery 193 of the wireless communication module 190. In the embodiment shown in FIG. 15, the wireless module 190 may include a second module interface 195b at the proximal portion of the wireless module 190. The second module interface 195b may be configured to connect to a console interface cable or a charger cable. Thus, the TEE probe connected to the wireless communication module 190 of FIG. 15 can work either wirelessly or wired to the console via the console interface cable.

In FIG. 16 and 17 are diagrams of embodiments of wireless communication module 190. The wireless communication module 190 of FIG. 16 may contain components similar or identical to those shown in FIG. 15, such as a radio module 191, a microcontroller 192a, and a battery 193. The battery 193 may be connected to a power manager 199. Power manager 199 may be configured to distribute power from battery 193 to other components of the wireless module, such as microcontroller 192a and radio module 191. In the embodiment depicted in FIG. 16, the wireless communication module 190 may include a housing 197 that houses the electrical components of the wireless communication module 190. According to other embodiments, such as the embodiment of FIG. 17, a portion of the wireless communication module 290 may not include its own housing, and may be placed inside the handle 220 of the TEE probe. In the embodiment of FIG. 17, handle 220 may include a console interface 211 rather than a first or second module interface. The handle 220 may be configured to be controlled wirelessly from the console 180, or via a wired connection containing a console interface cable that is connected to the console interface 211 on the handle 220 (e.g., FIG. 14) and to the console 180.

According to FIG. 16, radio module 191 may receive a radio signal from console 180 at antenna 194. This radio signal may include, for example, a command signal and operating instructions. The radio module 191 may convert the radio signal into an electrical signal for transmission to the microcontroller 192a. Upon receipt of an electrical signal, the microcontroller 192a of the wireless communication module sends the specified electrical signal to the appropriate component, for example, to the handle 120. The battery 193 can supply power to the radio module and the microcontrollers 192a, 192b through the power manager 199. The power manager 199 may be configured to distribute an appropriate amount of power to each of the components of the wireless communication module 190. On the other hand, an external charger may provide power to the various components of the wireless communication module 190 via the power manager 199 . In some embodiments, an external charger may be configured to charge the battery 193 while providing power to the components of the wireless communication module 190. In other embodiments, the external charger only powers and charges the battery 193, while the battery 193 provides power to the components of the wireless communication module. In still other embodiments, battery 193 may provide power to components of other parts of the TEE probe system, such as components of handle 120 and gastroscope 130. In some embodiments, battery 193 of wireless communication module 190 provides all of the power needed to operate the TEE probe system.

A user interface 198, which may include one or more user command selectors, such as buttons, dials, knobs, toggle switches, levers, joysticks, touch switches, and the like, may be coupled to the body of the wireless communication module 190, and may be configured to receive a command from a user. In some embodiments, a user may control one or more aspects of the operation of the wireless communication module 190 and/or the TEE probe 110 by manipulating the user interface 198 (eg, by pressing a button). The user interface 198 then sends the user command signal to the microcontroller 192b. The microcontroller 192b is configured to receive the user command signal and transmit the user command signal to the appropriate component, such as the power manager 199 or the microcontroller 192a. For example, user interface 198 may be configured to receive a command signal from a user to turn off one or more components of wireless communication module 190. In other embodiments, the user interface 198 may be configured to control one or more aspects of the scanning or operation of the TEE probe, or the movement of the distal portion 139 of the gastroscope 130.

In one embodiment, microcontroller 192a of wireless communication module 190 may receive ultrasound image data from handpiece 120. Microcontroller 192a may send ultrasound image data to radio module 191, which will then wirelessly transmit ultrasound image data to console 180 via antenna 194. Radio module 191 may be configured to convert the ultrasound image data transmitted by the microcontroller 192a from an electrical signal to a radio signal.

In FIG. 17 shows a portion of the wireless communication module 290 of the handle 220, which may include components similar or identical to those of the wireless communication module of FIG. 16. For example, a portion of the wireless communication module 290 includes a radio module 291 containing an antenna 194, a microcontroller, a battery and power manager, a microcontroller, a console interface, and a user interface 298. In this regard, the wireless communications module 290 portion of the handle 220 may be configured to perform similar or identical functions as described with respect to the embodiment shown in FIG. 16. In the embodiment of FIG. 17, a portion of the wireless communication module 290 may be housed within the handle 220 rather than being a separate unit or attachment. In other words, the handle 220 contains part of the wireless communication module 290 and related components. Thus, as described above, the portion of the wireless communication module 290 corresponding to the embodiment shown in FIG. 17 does not include a separate housing, or a first or second module interface.

In FIG. 18 is a flow diagram of one embodiment of a method 300 for wirelessly controlling a TEE probe gastroscope. According to some embodiments of the invention, the steps of method 300 may be implemented by means of a TEE probe and associated components depicted in FIG. 3-17. It should be understood that certain steps of the method 300 may be performed in a different order than that shown in FIG. 18; additional stages may be provided before, during and after certain stages; and/or some of the described steps may be replaced or omitted in other embodiments of the invention.

In step 310, the TEE probe containing the wireless communication module receives a wireless command signal from the console. The command signal may contain instructions for moving the tip of the gastroscope. The command signal may be wirelessly received by the radio module of the wireless communication module. At step 320, the radio module sends a command signal to the controller. In step 330, the controller, upon receiving the command signal, energizes an actuator, such as a motor, to actuate the actuator. Applying voltage by the controller to the actuator may include an instruction for the power source to apply power to the actuator. At step 340, the actuator performs an action to retract the traction cable connected to the tip of the gastroscope or the distal part of the gastroscope to move or deflect the distal part.

When the tip of the gastroscope or the distal part of the gastroscope moves or deviates, the tip of the gastroscope can apply force to the patient's esophagus, and vice versa. In step 350, a force sensor in the gastroscope tip measures the force applied to the tip. At step 360, the force sensor transmits a force detection signal, which may include the amount of force applied to the gastroscope tip, to the force sensor controller connected to the actuator and the wireless communication module. In step 365, the force sensor controller compares the measured force value with a predetermined threshold. At 370, if the measured force exceeds a threshold, then the force sensor controller instructs the motor to adjust the motor output or stop the motor. In some embodiments, the step of instructing the motor to adjust the motor output or shut down the motor may comprise instructing the power source to decrease the voltage applied to the motor. In some embodiments, if the measured force exceeds a threshold, then the force sensor controller may instruct the motor to reverse the direction of rotation to return the gastroscope tip to its previous position within the patient's esophagus.

At 380, when the force sensor controller determines that the measured force is above the set threshold, the force sensor controller also sends an overforce signal to the console. This transmission may be performed wirelessly by means of a wireless communication module. At 390, when the console receives an overforce signal, the console activates a force detection indicator to indicate to the clinician or user that the detected force is above a predetermined threshold. In this way, the physician or user can be made aware that too much force has been applied to the esophagus and that the motor may stop the movement of the gastroscope tip inside the patient's esophagus. Such feedback can be useful for a doctor who controls the TEE probe wirelessly. Without such feedback, the clinician might have difficulty maneuvering the distal end of the gastroscope inside the patient's esophagus. According to some embodiments of the invention, the force detection indicator may be a warning light, an icon on the screen, a warning sound, or a combination of these alarms.

In FIG. 19 is a flow diagram of one embodiment of a method 400 for wirelessly transmitting ultrasound imaging data to a console. In some embodiments, the steps of method 400 may be performed by means of a TEE probe and associated components depicted in FIG. 3-11. It should be understood that the steps of method 400 may be performed in a different order than that shown in FIG. 19; additional stages may be provided before, during and after certain stages; and/or some of the described steps may be replaced or omitted in other embodiments of the invention.

At 410, the ultrasound transducer may acquire ultrasound imaging data by emitting ultrasound energy in the form of ultrasound waves in the patient's body. The ultrasonic transducer detects reflected ultrasonic waves or echoes and converts the reflected ultrasonic waves into electrical signals containing ultrasonic image data. In step 420, the ultrasound transducer transmits the ultrasound image data to a microbeamformer, which may be similar or identical to microbeamformer 144 shown in FIG. 11. Said microformer receives, processes the ultrasound image data, and in step 430, the processed ultrasound image data in the microformer is transmitted to the beamformer. In some embodiments, the microbeamformer is located within the gastroscope and the beamformer is located in the handle. According to other embodiments, the beamformer may be located in the console. The beamformer receives the partially processed ultrasound image data, performs additional processing (or beamforming) of the ultrasound imaging data to be displayed for the clinician. At step 440, the beamformed ultrasound image data is provided to a signal processor, configured to further process the beamformed ultrasound image data to generate an ultrasound image to be displayed for the clinician. According to some embodiments of the invention, the processing of the ultrasound image data performed by the microbeamformer, the beamformer, and the signal processor can reduce the amount of data that must be transmitted to the console. In step 450, the signal processor transmits the processed ultrasound image data to the wireless communication module, and in step 460, the wireless communication module receives and wirelessly transmits the processed ultrasound image data to the console.

Those skilled in the art will appreciate that the apparatus, systems, and methods discussed above may be modified in various ways. Accordingly, those of ordinary skill in the art should understand that the embodiments covered by the present description are not limited to the specific examples given. In this regard, while illustrative embodiments have been presented and described, it is contemplated that a wide range of modifications, changes, and substitutions may be made to the invention described above. It should be understood that such changes can be made to the invention described above without departing from the spirit and scope of the same. Accordingly, it is expedient to interpret the appended claims in a broad sense in accordance with the present description.

Claims (41)

1. Probe for transesophageal echocardiography, containing: handle (120); a gastroscope (130) connected to the handle with the possibility of detachment and configured to be placed in the patient's esophagus, while the gastroscope includes an ultrasonic transducer (140) located in the distal part of the gastroscope and configured to receive ultrasound imaging data; handle interface (150) located in the distal part of the handle; and a gastroscope interface (160) located in the proximal part of the gastroscope, a wireless communication module (190) connected to the handle and configured to communicate with the gastroscope, comprising: element (194) wireless; and a microcontroller (121) configured to communicate with the wireless communication element, moreover, the wireless communication module is configured to receive a command signal from the console (180) located at a distance from the probe for transesophageal echocardiography, and transmit ultrasound imaging data to the console, wherein the microcontroller is configured to transmit an electrical signal to the gastroscope to control the movement of the distal part of the gastroscope in a response to the received command signal, wherein the handle and the gastroscope are detachably connected to each other by means of a handle interface and a gastroscope interface, wherein the handle interface is configured to transmit an electrical signal to the gastroscope via the gastroscope interface to control the distal part of the gastroscope, wherein the wireless communication module (190) is placed inside the handle, wherein the wireless communication module (190) comprises a housing connected to the handle, wherein when the wireless communication module is connected to the handle, the wireless communication module transmits an electrical signal to the gastroscope. 2. The transesophageal echocardiography probe of claim 1, further comprising a user interface (198) coupled to the handle and configured to receive manual input from a user to control the gastroscope. 3. The probe for transesophageal echocardiography according to claim 1, in which the gastroscope contains: a traction cable connected to the distal part of the gastroscope; And executive body connected to the traction cable, wherein the microcontroller is configured to transmit an electrical signal to the actuator to actuate the traction cable to move the distal part of the gastroscope. 4. The transesophageal echocardiography probe of claim 1, wherein the microcontroller is configured to transmit an electrical signal to control the ultrasound transducer in response to a command signal. 5. The transesophageal echocardiography probe of claim 1, wherein the ultrasound transducer includes an array of ultrasound transducers, wherein the handle includes a beamformer configured to communicate with the array of ultrasound transducers. 6. The transesophageal echocardiography probe of claim 5, wherein the handle includes a signal processor configured to communicate with the beamformer. 7. The transesophageal echocardiography probe of claim 5, wherein the gastroscope comprises a microbeamformer configured to communicate with an array of ultrasound transducers and with the beamformer. 8. The probe for transesophageal echocardiography according to claim 1, further comprising a battery configured to power the wireless communication module and the gastroscope. 9. The probe for transesophageal echocardiography according to claim. 1, in which the specified housing is connected in a removable way to the handle using at least one of the following means: USB interface or interface in the form of spring pins. 10. A method for wirelessly controlling a transesophageal echocardiography probe according to claim 1, comprising the steps of: through a wireless communication element connected to the handle of the transesophageal echocardiography probe, wirelessly receive a command signal transmitted by a console located at a distance from the transesophageal echocardiography probe, while the gastroscope of the transesophageal echocardiography probe is placed in the patient's esophagus, and the gastroscope is connected to the handle , but with the possibility of detachment; by means of a wireless communication element transmit the received command signal to the controller connected to the handle; And in response to the received command signal, voltage is applied by means of the controller to the actuator connected to the gastroscope to control the movement of the distal part of the gastroscope inside the esophagus, by means of an ultrasonic transducer located in the distal part of the gastroscope, ultrasonic imaging data is obtained; And wirelessly transmitting ultrasound imaging data to the console via a wireless communication element. 11. The method of claim 10, further comprising the steps of: in the controller connected to the handle, receive a feedback signal from the executive body; And based on the feedback signal, the movement of the distal part of the gastroscope is changed by means of the executive body. 12. The method according to claim 11, wherein the step of receiving a feedback signal from the actuator comprises receiving a force detection signal, wherein the step of changing the movement of the distal part of the gastroscope comprises stopping the movement of the distal part of the gastroscope by the actuator. 13. The method of claim 11, further comprising the steps of: wirelessly transmitting a feedback signal to the console via the wireless communication element, the feedback signal comprising a force detection signal; And in response to the received force detection signal, the force detection indicator is activated. 14. The method of claim 10, further comprising the steps of: receiving, at the beamformer, the ultrasound imaging data obtained by the ultrasound transducer; And transmitting the ultrasonic imaging data processed by the beamformer to the wireless communication element. 15. The method of claim 14, further comprising the steps of: receiving, at the microbeamformer, ultrasonic imaging data obtained by the ultrasonic transducer; And transmitting the ultrasonic imaging data processed by the microbeamformer to the beamformer.

Images