Handle assembly for transesophageal echocardiography

Abstract

To provide a simplified transesophageal echocardiography (TEE) probe mid-handle assembly for actuating the pull cables that control the flexion of the distal end of the gastroscope portion of a TEE probe.SOLUTION: The assembly includes a containment frame, two control wheels, two coaxial shafts each coupled to one of the control wheels, with an elongated flexible member wrapped around each shaft. The elongated flexible members may be friction belts, timing ladders, pulley cables, timing belts, or drive tapes to translate the rotational motion of the control wheels into linear motion of the gastroscope pull cables. The assembly may also include a brake switch that, when engaged, applies a resistance to rotation of the shafts and control wheels.SELECTED DRAWING: Figure 2

Description

[Technical field]

[0001]

[0001] The present disclosure relates generally to imaging of a patient's organs using transesophageal echocardiography (TEE), and to controlling a TEE probe via a pull cable disposed in a handle. For example, some embodiments of the present disclosure are suitable for controlling the position, orientation, and bending of a TEE gastroscope probe. [Background technology]

[0002]

[0002] Observing the condition and function of a patient's heart is a difficult and dangerous procedure. Echocardiography reduces the risk of injury to the patient by using ultrasound imaging techniques. In echocardiography, a physician uses an ultrasound probe containing one or more ultrasound transducers to obtain images of various angles of the patient's heart. The ultrasound transducer emits ultrasound energy in the form of ultrasound waves to produce an image of the heart. The ultrasound waves are partially reflected by discontinuities resulting from tissue structures, red blood cells, and other features of interest. The echoes, or reflected ultrasound waves, are received by the ultrasound transducer and transmitted to a signal processor. The signal processor processes the received ultrasound echoes to generate an image of the heart near where the ultrasound transducer is located.

[0003]

[0003] One common echocardiography procedure is transthoracic echocardiography (TTE), which involves placing an ultrasound probe on a patient's chest or abdomen to obtain images of the patient's heart at various angles. Although TTE is a relatively non-invasive procedure, ultrasound waves must travel through several layers of tissue and bone to reach the heart, and the echoes must travel back through the same tissue and bone to reach the ultrasound transducer. These thick layers of tissue and bone weaken the intensity of the echoes, degrading the quality of the images obtained.

[0004]

[0004] Transesophageal echocardiography (TEE) involves obtaining ultrasound images of the heart using a TEE probe positioned in the patient's esophagus. The TEE probe also uses ultrasound waves to obtain images of the patient's heart. Transesophageal echocardiography is advantageous because the heart is close to the esophagus, which results in higher quality images. To obtain images using a TEE probe, a physician inserts a gastroscope containing an ultrasound transducer into the patient's esophagus and guides the ultrasound transducer to an area near the heart. The physician manipulates a distal portion of the gastroscope within the patient's esophagus to guide the ultrasound transducer into position and maintain contact with the esophageal wall to facilitate the transmission and reception of ultrasound waves. Summary of the Invention [Problem to be solved by the invention]

[0005]

[0005] It should be appreciated that such commonly used TEE handles have numerous drawbacks, including cost, durability, reliability, ergonomics, electrical grounding, and others. The handle portion of a conventional TEE probe includes numerous complex machined parts and assemblies that require very precise manufacturing tolerances, expensive materials, and significant assembly time and labor. For example, a brake assembly includes up to four parts that work in conjunction with each other. The articulation of current TEE probes includes a stainless steel pull wire system driven by a nested rack and pinion system fabricated from hardened beryllium copper. These metal components create electrical insulation problems. Left / right and front / rear control wheels are attached to the respective pinion shafts to provide user input to drive the system. The pinion, rack, housing and associated components are all made of metal, as are the external user handle and possibly the patient contact handle of the control housing. All internal structures are electrically grounded, while the metal handle is electrically isolated from the internal structures via a complex set of static and dynamic overlapping isolation components that provide sufficient electrical creepage and clearance over the full range of positions provided by the articulation mechanism. Further isolation is achieved via a distal plastic isolation member attached to the main rack and pinion housing via a dovetail engagement. The distal isolation is prone to failure due to its complex attachment to the metal housing. [Means for solving the problem]

[0006] A transesophageal echocardiography (TEE) probe mid-handle assembly is disclosed that includes improved and simplified components and has particular, but not exclusive, utility for control of a TEE probe for imaging of the human heart.

[0007]

[0007] The embodiments of the present disclosure provide an improved mid-handle assembly for a transesophageal echocardiography (TEE) probe for producing images of an organ with improved cost and manufacturability characteristics. The TEE probe mid-handle assembly provides a non-metallic design for a TEE probe that translates the rotation of a user control knob to a linear articulation pull of a catheter. The assembly includes a molded plastic containment frame that electrically isolates the internal components from the metallic external components, if any. The assembly further includes one or more floating drive shafts for translating the rotation of the knob to the pull elements, and one or more non-metallic pull elements in communication with the one or more drive shafts. The TEE mid-handle assembly achieves TEE gastroscope articulation and electrical isolation from a ground structure in a more direct and more reliable manner by eliminating the conventional rack and pinion and utilizing a non-metallic method of translating the rotational user control to linear pulling of the articulation control cable. Additionally, non-metallic molded control knobs, cams, and distal insulators are used to nest and capture a pair of articulation control shafts, which has the advantage of naturally insulating the articulation assembly from an external metal handle, if one is present.

[0008] In one example, the TEE probe includes simplified mechanisms such as friction belts, timing ladders, pulley cables, timing belts, and tape drives that replace rack-and-pinion systems to couple control knobs to pull cables that steer the imaging elements. In some embodiments, the brake assembly is simplified and is a unitary brake switch (i.e., formed as a single piece). In some embodiments, machined metal components are replaced with molded plastic components that have tight manufacturing tolerances and improved electrical insulation properties. In some embodiments, multi-part assemblies and enclosures are replaced by assemblies with fewer parts, fewer assembly steps, fewer points of failure, lighter weight, and improved ease of operation.

[0009]

[0009] In an exemplary embodiment, a transesophageal echocardiography (TEE) probe includes a housing frame, a first control input disposed on an exterior of the housing frame, a first shaft disposed on an interior of the housing frame and coupled to the first control input, a first elongated flexible member having a first end and a second end, the first elongated flexible member wrapped around the first shaft, a first pull cable attachment coupled to the first end of the first elongated flexible member, a second pull cable attachment coupled to the second end of the first elongated flexible member, and a first pull cable attachment coupled to the first end of the first elongated flexible member. The gastroscope includes a first pull cable attached to the pull cable attachment and a second pull cable attached to the second pull cable attachment, and when the first control input is actuated, the first shaft rotates, causing the first and second ends of the first elongated flexible member to move linearly, thereby moving one of the first or second pull cables in a first direction and the other of the first or second pull cables in an opposite second direction, such that a distal portion of the gastroscope coupled to the first and second pull cables is bent in accordance with the movement of the first and second pull cables.

[0010]

[0010] In some embodiments, the TEE probe includes a second control input disposed external to the storage frame, a second shaft disposed internal to the storage frame and coupled to the second control input, a second elongated flexible member having a first end and a second end, the second elongated flexible member wrapped around the second shaft, a third pull cable attachment coupled to the first end of the second elongated flexible member, a fourth pull cable attachment coupled to the second end of the second elongated flexible member, and a fourth pull cable attachment coupled to the third pull cable attachment. and a fourth pull cable attached to the fourth pull cable attachment, wherein when the second control input is rotated, the second shaft rotates such that the first and second ends of the second elongated flexible member move linearly, thereby causing one of the third or fourth pull cables to move in a first direction and the other of the third or fourth pull cables to move in an opposite second direction, such that a distal portion of the gastroscope coupled to the third and fourth pull cables is bent in accordance with the movement of the third and fourth pull cables.

[0011] In some embodiments, the TEE probe further includes a unitary brake switch that, when rotated to a first position, applies resistance to rotation of the first and second shafts and, when rotated to a second position, allows the first and second shafts to rotate without resistance. In some embodiments, at least one of the control input, the shaft, the elongated flexible member, the brake switch, or the housing frame is non-conductive. In some embodiments, at least one of the control input, the shaft, the brake switch, or the housing frame is made of molded plastic. In some embodiments, the first and second elongated flexible members are made of an elastomeric compound molded onto a nylon reinforcing member. In some embodiments, the first control input directs anterior and posterior bending of the distal portion of the gastroscope and the second control input directs left / right bending of the gastroscope. In some embodiments, the first and second elongated flexible members are friction belts. In some embodiments, the first and second shafts include gears or pinions and the first and second elongated flexible members are timing ladder belts that are coupled to the gears or pinions. In some embodiments, the first and second shafts each include a socket and the first elongated flexible member is a pulley cable that is fastened to the first shaft by a crimped ball or screw attachment that fits into a socket in the first shaft and the second elongated flexible member is a pulley cable that is fastened to the second shaft by a crimped ball or screw attachment that fits into a socket in the second shaft. In some embodiments, the first and second shafts include gears or pinions and the first and second elongated flexible members are timing belts that are coupled to the gears or pinions. In some embodiments, the first and second shafts include gears or pinions and the first and second elongated flexible members are drive tapes that are coupled to the gears or pinions.

[0012] In some embodiments, the pull cable attachments are formed directly on the elongated flexible member. In some embodiments, the pull cable attachments each include a screw-type tensioning mechanism. In some embodiments, the TEE probe further includes an outer handle casing. In some embodiments, the first and second shafts are coaxial. In some embodiments, the TEE probe further includes a floating, non-rotating, moving inner shaft attached to the housing frame and positioned between the first and second shafts to limit mutual coupling of motion between the first and second shafts.

[0013]

[0013] In an exemplary embodiment, a method for transesophageal echocardiography (TEE) includes controlling bending of a distal portion of a gastroscope of the TEE probe based on manipulation of a control input of the TEE probe, wherein the TEE probe includes a gastroscope, a housing frame, a control input, a shaft coupled to the control input, an elongated flexible member including a first end and a second end, the elongated flexible member wrapped around the shaft, a first pull cable attachment attached to the first end of the first elongated flexible member, and a second pull cable attachment attached to the second end of the first elongated flexible member, a handle assembly coupled to the gastroscope, the handle assembly including a first pull cable attachment attached to the first end of the first elongated flexible member, and a second pull cable attachment attached to the second end of the first elongated flexible member, and a first pull cable attached to the first pull cable attachment and a distal portion of the gastroscope, and a second pull cable attached to the distal portion, wherein controlling the bending comprises rotating a shaft coupled to the control input in response to manipulation of the control input, linearly moving the first pull cable attachment and the second pull cable attachment in response to rotating the shaft, and linearly moving the first pull cable and the second pull cable attachment in response to corresponding movements of the first pull cable attachment and the second pull cable attachment to cause bending of the distal portion of the gastroscope, and in response to rotation of a brake switch of the handle assembly to a first position, applying resistance to rotation of the shaft, and in response to rotation of the brake switch to a second position, allowing rotation of the shaft without resistance. In some embodiments, at least one of the brake switch, the control input, the shaft, the elongated flexible member, the storage frame, the first pull cable attachment, or the second pull cable attachment are fabricated from molded plastic.

[0014]

[0014] In an exemplary embodiment, the TEE probe comprises a gastroscope, a handle assembly coupled to the gastroscope, the handle assembly including an elongated flexible member around which the shaft is wound, the elongated flexible member having a first end and an opposite second end, the elongated flexible member comprising at least one of a friction belt, a timing ladder, a pulley cable, a timing belt, or a drive tape, a first pull cable attachment and a second pull cable attachment attached to the first end and the second end, respectively, of the elongated flexible member, and a unitary brake switch configured to selectively apply resistance to rotation of the shaft, and a brake switch attached to the first pull cable attachment and a distal portion of the gastroscope. the gastroscope includes a first pull cable and, for each elongated flexible member, a second pull cable attachment and a second pull cable attached to a distal portion of the gastroscope, wherein when the control input is operated, the shaft rotates, resulting in a linear movement of the first and second pull cable attachments and a corresponding linear movement of the first and second pull cables to bend the distal portion of the gastroscope, a unitary brake switch, when rotated to a first position, applies resistance to rotation of the shaft and when rotated to a second position, allows the shaft to rotate without resistance, and at least one of the brake switch, the control input, the shaft, the elongated flexible member, the first pull cable attachment, or the second pull cable attachment are fabricated from molded plastic.

[0015]

[0015] This Summary is provided to introduce in a simplified form a selection of concepts that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to limit the scope of the claimed subject matter. A more extensive presentation of the features, details, utilities, and advantages of the TEE probe handle assembly defined in the claims is provided in the following written description of various embodiments of the present disclosure and illustrated in the accompanying drawings.

[0016]

[0016] Additional aspects, features, and advantages of the present disclosure will become apparent from the following detailed description.

[0017]

[0017] Exemplary embodiments of the present disclosure are described with reference to the accompanying drawings. [Brief description of the drawings]

[0018] [Figure 1]

[0018] FIG. 1 is a diagram of a transesophageal echocardiography (TEE) ultrasound imaging system in accordance with at least one embodiment of the present disclosure. [Diagram 2]

[0019] FIG. 1 is a side elevation view of a TEE probe in accordance with at least one embodiment of the present disclosure. [Diagram 3]

[0020] FIG. 3 is a diagrammatic view of a handle portion of the TEE probe of FIG. 2 in accordance with at least one embodiment of the present disclosure. [Figure 4]

[0021] FIG. 1 is a semi-transparent isometric view of the internal workings of a mid-handle assembly of a conventional TEE. [Figure 5A]

[0022] FIG. 13 is a lateral side elevational view of a distal portion of a TEE probe, showing anterior and posterior bending of the distal portion, in accordance with at least one embodiment of the present disclosure. [Figure 5B]

[0023] FIG. 5B is a front side elevational view of the distal portion of the TEE probe of FIG. 5A , illustrating left and right bending of the distal portion, in accordance with at least one embodiment of the present disclosure. [Figure 5C]

[0024] 5B is a front side elevational view of the distal portion of the TEE probe of FIG. 5A illustrating counterclockwise rotation, clockwise rotation, forward and backward positioning of the distal portion in accordance with at least one embodiment of the present disclosure. [Figure 5D]

[0025] FIG. 5B is an isometric view of a distal portion of the TEE probe of FIG. 5A illustrating increasing and decreasing multi-faceted angles of an ultrasound transducer, in accordance with at least one embodiment of the present disclosure. [Figure 6]

[0026] FIG. 13 is an isometric view of a portion of an exemplary TEE probe mid-handle mechanism incorporating a friction belt in accordance with at least one embodiment of the present disclosure. [Figure 7]

[0027] FIG. 13 is an isometric view of a portion of an exemplary TEE probe mid-handle mechanism incorporating a friction belt in accordance with at least one embodiment of the present disclosure. [Figure 8]

[0028] FIG. 1 is an isometric view of a portion of a mid-handle mechanism of an example TEE probe incorporating a timing ladder, in accordance with at least one embodiment of the present disclosure. [Figure 9]

[0029] FIG. 13 is an isometric view of a portion of an exemplary TEE probe mid-handle mechanism incorporating a pulley cable, in accordance with at least one embodiment of the present disclosure. [Figure 10]

[0030] FIG. 13 is an isometric view of a portion of an exemplary TEE probe mid-handle mechanism incorporating a pulley cable, in accordance with at least one embodiment of the present disclosure. [Figure 11]

[0031] FIG. 13 is an isometric view of a portion of an exemplary TEE probe mid-handle mechanism incorporating a pulley cable, in accordance with at least one embodiment of the present disclosure. [Figure 12]

[0032] FIG. 13 is an isometric view of a portion of an exemplary TEE probe mid-handle mechanism incorporating a pulley cable, in accordance with at least one embodiment of the present disclosure. [Figure 13]

[0033] FIG. 13 is an isometric view of a portion of a mid-handle mechanism of an example TEE probe incorporating a timing belt in accordance with at least one embodiment of the present disclosure. [Figure 14a]

[0034] FIG. 1 is an isometric view of a portion of a mid-handle mechanism of a conventional TEE probe that uses a rack and pinion mechanism to transfer motion from a control wheel to a pull cable. [Figure 14b]

[0035] FIG. 13 is an isometric view of a portion of a mid-handle mechanism of an example TEE probe incorporating a timing belt in accordance with at least one embodiment of the present disclosure. [Figure 15]

[0036] FIG. 13 is an isometric view of a portion of a mid-handle mechanism of an example TEE probe incorporating a timing belt in accordance with at least one embodiment of the present disclosure. [Figure 16]

[0037] FIG. 1 is an isometric view of a tape drive in accordance with at least one embodiment of the present disclosure. [Figure 17]

[0038] FIG. 13 is an isometric view of a portion of a mid-handle mechanism of an example TEE probe incorporating a timing belt in accordance with at least one embodiment of the present disclosure. [Figure 16] FIG. 1 is a detailed view of an example pull cable attachment assembly in accordance with at least one embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0019]

[0040] For the purpose of facilitating an understanding of the principles of the present disclosure, reference will now be made to the embodiments shown in the drawings, and specific language will be used to describe the embodiments. It will nevertheless be understood that no limitations to the scope of the present disclosure are intended. Modifications and further changes to the described devices, systems, and methods, and further applications of the principles of the present disclosure, as would normally occur to one skilled in the art to which the present disclosure pertains, are fully intended and included within the present disclosure. In particular, features, components, and / or steps described with respect to one embodiment are fully intended to 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.

[0020]

[0041] FIG. 1 shows a diagram of an ultrasound imaging system 100 according to an embodiment of the present disclosure. In some embodiments, the ultrasound imaging system includes a TEE probe. Referring to the embodiment of FIG. 1, the TEE probe 110 includes a gastroscope 130 in communication with a handle 120, which in turn communicates with a console 180, which includes a housing 182, a processor 184, a memory 186, and a display 188. The processor 184, the memory 186, and the display 188 may be integrated with the console, or may be detachable or otherwise independent. The memory may include either or both of a random access memory (RAM) and long-term storage, including, but not limited to, a hard disk drive (HDD), a solid-state disk (SSD), a CD-ROM, a flash drive, or other related technology.

[0021]

[0042] An ultrasound transducer array 135 disposed at a distal portion of the gastroscope 130 acquires ultrasound imaging data and transmits the ultrasound imaging data to the console 180 via communication lines extending through the gastroscope 130, the handle 120, and a cable extending between the TEE probe 110 and the console 180. Additionally, the gastroscope 130 and the ultrasound transducer array 135 receive control data from the console 180 via the handle 120, or receive control inputs directly from a control surface of the handle 120 to control various aspects of the TEE scan, such as one or more firing sequences of the ultrasound transducer array and movement or bending of the distal portion of the gastroscope 130.

[0022]

[0043] In some embodiments, the gastroscope 130 transmits ultrasound imaging data to the console 180 through the handle 120. The handle 120 further includes electronic components for conditioning or processing the ultrasound imaging data transmitted to the console 180.

[0023]

[0044] 2 is a side elevational view of the TEE probe, showing the TEE probe 210 including the gastroscope 130, the handle 120, the console interface cable 270, and the connector 175. The TEE handle 120 is permanently connected to the gastroscope at the probe interface connection 155, through which the continuous pull cable, power wires, signal wires, and other supporting hardware are routed. The handle 120 is also permanently connected to the console interface cable 270 at the console interface cable connection 275, through which the continuous power wires, signal wires, and other supporting hardware are routed. A distal end of the cable 270 is coupled to the handle 120 at the console interface cable connection 270. A proximal end of the cable 270 is coupled to the connector 175. The connector 175 is removably mechanically coupled to the housing 182 of the console 180 to facilitate signal communication between the console 180, the handle 120, and / or the transducer array 135. The connector 175 is referred to in some embodiments as a patient interface module (PIM). The TEE probe 210 includes an integrated unit, where the gastroscope 130 and the console interface cable 270 are permanently secured to the handle 20 at permanent connections 155, 275 by adhesives, screws, welding, or other attachments that are not easily separated by the physician or user.

[0024]

[0045] The term "permanent" is used broadly to refer to modes of coupling or attachment that are not configured or designed for periodic removal and reattachment. Thus, although the two coupled components are physically separated, the present disclosure refers to a coupling or attachment as permanent if the components are not removed in normal medical use of the device. The terms "coupled," "couple," "coupled," or "connected" are used broadly to refer to any combination, attachment, or connection. The present disclosure refers to two components as coupled even if they are permanently fixed to each other or integrally formed as a single unit. "Coupled," as used in this disclosure, contemplates direct and indirect modes of coupling or attachment, as well as detachable modes of coupling or attachment. Two components are referred to as "coupled to each other" even if the two components are not in direct contact with each other or there are one or more connecting components between the two components. "Detachable, separable, or removable" is used to refer to a mode of coupling or attachment that is configured to be separated and reattached in the course of normal use of the device or system, such as before, during, or after a medical procedure.

[0025]

[0046] The gastroscope 130 includes an elongated body 237, a proximal portion 232, and a distal portion 239 including a probe tip 240. The probe tip 240 includes an ultrasound transducer array 135 (FIG. 1). The elongated body 237 is flexible so that it can be guided through the patient's esophagus by manipulating movement controls 223, 225 coupled to the handle 120. The movement controls 223 and 225 are control inputs to the gastroscope and may take the form of wheels, knobs, dials, sliders, levers, or other related mechanical inputs. The response of the device to the manipulation of the control inputs allows the physician to control the movement of the distal portion 239 of the gastroscope 130. Controlling the movement of the distal portion 239 of the gastroscope 130 assists the physician in guiding the gastroscope 130 through the patient's physiology to the desired imaging location. A rigid or fixed configuration of the gastroscope may injure the patient and is not suitable for ultrasound imaging, which requires precise placement and sufficient contact with the patient's physiology to obtain an ultrasound image. The example handle 120 of FIG. 2 further includes beam steering controls 227 that affect the shape of the ultrasound imaging beam.

[0026]

[0047] 3 is a diagram of the handle portion of the TEE probe of FIG. 2. The gastroscope 130 includes first and second pull cables 333, 335 mechanically connected to first and second movement controls 223, 225 coupled to the handle 120. Such a configuration allows the physician to control the movement of the distal portion 239 of the gastroscope 130. As ultrasound imaging requires precise placement and sufficient contact with the patient's physiology to obtain an ultrasound image, controlling the movement of the distal portion 239 of the gastroscope 130 assists the physician in guiding the gastroscope 130 through the patient's physiology to the desired imaging location. In this manner, the pull cables 333, 335 and flexible components assist the physician in obtaining ultrasound images of the patient's organs. The first and second pull cables 333, 335 are mechanically connected to the first and second movement controls 223, 225 so that a physician manipulating the first and second movement controls 223, 225 receives tactile feedback from the distal portion 239 of the gastroscope 130 as the distal portion 239 presses against the wall of the esophagus. The exemplary handle of FIG. 3 further includes transducer wiring 343 to carry signals from the gastroscope 130 to the console 180.

[0027]

[0048] 4 shows a semi-transparent isometric view of the internal mechanism 399 of an exemplary TEE mid-handle assembly of a conventional TEE probe. The first and second motion controls 222, 224 create rotation in the corresponding first and second pinion shafts 422, 424, which in turn create linear motion in the first and second racks 452, 454 via a rack-and-pinion mechanism. Additional first and second racks 452, 454 are on the far side of the visible mechanism and operate in conjunction with the visible racks 452, 454 according to the same principles. The first and second racks 452, 454 are coupled to the first and second pull cables to extend or retract them, thereby controlling the movement of the distal portion of the gastroscope.

[0028]

[0049] The mechanism thus described is housed within a containment frame 459 which includes a gear housing 409 and a distal insulator 419. The mid-handle mechanism further includes a brake switch 228 which is engaged to apply resistance to rotation of the travel controls 222 and 224. The rack and pinion mechanism requires tight manufacturing tolerances to function properly and is therefore machined from steel, full hardened beryllium copper, or other metal. The brake switch 228 is also a multi-part assembly of four or more parts. The distal insulator is machined from a hard polymeric material such as 20% glass filled polycarbonate. The rack frame or gear housing requires a number of openings, through holes, and threaded holes to accommodate the other components of the mid-handle assembly 399 and these features require fairly tight manufacturing tolerances. The gear housing is therefore machined from a metal such as nickel plated 6061-T6 aluminum.

[0029]

[0050] 5A is a lateral side elevational view of the distal portion 239 of the TEE probe gastroscope 130 showing various modes of anterior and posterior bending of the distal portion 239 including the imaging element 542. Anterior / posterior bending and right / left bending are achieved by retracting and releasing one or more pull cables corresponding to one or more modes of movement. In some embodiments, the physician controls the anterior or posterior bending of the distal portion 239 of the gastroscope 130 by retracting or releasing the first pull cable 333. Because the first pull cable 333 includes multiple individual cables or wires, controlling the anterior or posterior bending of the distal portion of the gastroscope 130 includes retracting one of the individual wires of the first pull cable 333 while keeping another of the individual wires of the first pull cable 333 stationary.

[0030]

[0051] 5B is a front elevational view of the distal portion 239 of the TEE probe gastroscope 130 of FIG. 5A showing various modes of left and right bending of the distal portion 239 including the imaging element 542. Right / left bending is achieved by retracting and releasing one or more pull cables corresponding to one or more modes of movement. In some embodiments, the physician controls the forward or backward bending of the distal portion 239 of the gastroscope 130 by retracting or releasing the second pull cable 335. Because the second pull cable 335 includes multiple individual cables or wires, controlling the left and right bending of the distal portion of the gastroscope 130 includes retracting one of the individual wires of the second pull cable 335 while holding another of the individual wires of the second pull cable 335 stationary.

[0031]

[0052] Figure 5C is a front side elevational view of the distal portion of the TEE probe of Figure 5A showing modes of physical movement including counterclockwise rotation, clockwise rotation, advancement and retraction positioning of the distal portion. Such movement is accomplished by manually adjusting the gastroscope 130, such as by rotating a handle to rotate the gastroscope 130 within the patient's esophagus. The physician also advances or retracts the distal portion 239 of the gastroscope 130 within the patient's esophagus by advancing the handle toward or retracting it away from the patient's esophagus.

[0032]

[0053] Figure 5D is an isometric view of the distal portion of the TEE probe of Figure 5A showing increasing and decreasing multi-planar angles of the ultrasound transducer. The mode of electronic movement shown in Figure 5D does not require physical manipulation of the distal portion of the gastroscope, such as the modes of movement shown in Figures 5A-5C, but is accomplished by controlling one or more electronic aspects of the ultrasound transducer array or imaging elements 542. This is initiated via electronic commands from the console 180 or the beam steering control 227 in the handle 120.

[0033]

[0054] 5A-5D, the various illustrated modes of movement and bending of the distal portion 239 of the gastroscope 130 are controlled by one or more user input selectors (e.g., 223, 225 in FIG. 2) on the handle. For example, in one embodiment, anterior and posterior bending of the distal portion 239 of the gastroscope 130 is controlled by a first user input selector 223, while left and right bending is controlled by a second user input selector 225. Rotation, advancement, and retraction of the distal portion 239 is accomplished by manually rotating, advancing, and retracting the handle 120 of the TEE probe 110. Electronic beam angle movement is manipulated or adjusted by a third user input selector 227. As discussed above, the user input selectors 223, 225, and 227 each include at least one of an electronic button, dial, capacitive touch sensor, lever, switch, knob, joystick, or the like.

[0034]

[0055] 6 is an isometric view of a portion of an exemplary TEE probe mid-handle mechanism incorporating a friction belt, in accordance with at least one embodiment of the present disclosure. Rotation of shaft 423 creates linear motion of friction belt 623, which is attached to pull cable 333 by two pull cable attachment assemblies 620. Pull cable attachment assemblies 620 include clips, clamps, collars, collets, sleeves, thimbles, swivels, crimps, hooks, eye fittings, clevis fittings, stud fittings, ball and dome fittings, turnbuckles, tensioners, and other associated mechanical fittings suitable for attachment to the pull cable, as well as appropriate housings, fasteners, and adapters. Rotation of shaft 425 creates linear motion in friction belt 625, which is in turn attached to pull cable 335 by another pair of pull cable attachment assemblies 620. In this manner, rotation of the shaft controls the movement of distal end 239 of gastroscope 130. Gear housing 410 is also depicted. In one example, friction belts 623 and 625 are non-conductive.

[0035]

[0056] In one example, a portion of the pinion shafts 423 and 425 is inside the gear housing 410 and a portion of the shafts 423 and 425 that is outside the gear housing 410 is inside the control knobs 223 and 225, such that the shafts 423 and 425 have minimal or no visibility in the fully assembled device.

[0036]

[0057] FIG. 7 is an isometric view of a portion of an exemplary TEE probe mid-handle mechanism incorporating a friction belt, according to at least one embodiment of the present disclosure. The wrapping of belts 623 and 625 around corresponding shafts 423 and 435 is visible. This embodiment includes a different type of pull cable attachment assembly 620 and further includes an idler 720 to assist in the linear motion of belts 623 and 625, so that belts 623 and 625 wrap around the pinion shaft and past the idler in a push-pull motion. Belts 623 and 625 are fabricated from an elastomeric compound molded over Kevlar, nylon, or metal reinforcement members to reduce stretch and increase life. Pull cable attachment assembly 620 is molded directly onto the friction belt. Base 730 is also depicted.

[0037]

[0058] In the example shown in the figures, belts 623 and 625 are wrapped 180 degrees around shafts 423 and 425 (i.e., positioned partially around or around the circumference of the shafts) so that as the shafts rotate, the two ends of each belt move in opposite directions. It should be understood that other degrees of wrapping are possible, including degrees that result in substantially opposite motion (e.g., 170 or 190 degrees), degrees that result in substantially similar motion (e.g., 10 degrees, 0 degrees, or 370 degrees), and others.

[0038]

[0059] FIG. 8 is an isometric view of a portion of an example TEE probe mid-handle mechanism incorporating a timing ladder or timing ladder belt, in accordance with at least one embodiment of the present disclosure. In a manner similar to FIG. 6, the timing ladder 825 is coupled to a pinion shaft 425 inside the gear case 410, such that rotation of the shaft 425 creates linear motion of the timing ladder 825. However, unlike the friction belts 623 and 625 of FIG. 6, the timing ladder 825 includes features that engage with teeth on a gear or pinion, such that friction is not required for the ladder to maintain its position. The ladder belt 825 wraps around a corresponding pinion shaft 425 to create a push-pull motion. The ladder belt 825 is fabricated from an elastomeric compound that is molded onto steel, Kevlar, or nylon reinforcing members to reduce stretch and increase life. Additional ladder belts are added to the mid-handle mechanism and wrap around and engage the pinion shaft 423, so that one ladder belt controls the left / right bending of the distal portion 239 and the probe tip 240 and the other ladder belt controls the forward / backward bending of the distal portion 239 and the probe tip 240.

[0039]

[0060] Also depicted is the pinion shaft 423. In one example, the timing ladder 825 is non-conductive. The pull cable attachment assembly 620 is mechanically attached to and / or molded to the timing ladder 825.

[0040]

[0061] FIGURE 9 is an isometric view of a portion of an example TEE probe mid-handle mechanism incorporating a pulley cable, in accordance with at least one embodiment of the present disclosure. In a manner similar to FIGURES 6 and 8, pulley cable 925 is coupled to pinion shaft 425 inside gear case 410, such that rotation of shaft 425 creates linear motion of pulley cable 925. Shaft 423 is also depicted. Pull cable 335 is attached to pulley cable 925 via pull cable attachment assembly 620, assisted by crimped ball 920 at the end of pulley cable 925.

[0041]

[0062] In one example, the pulley cable 925 is made from a non-metallic, non-conductive rope, such as Kevlar or a similar material. In another example, the pulley cable 925 is made from a metal cable with a polymer overcoat. A pull cable attachment device 620, such as a threaded collet, remains attached to one end of the Kevlar rope and is used to attach to the final cable and adjust the final cable tension. An additional pulley cable is added to the middle handle mechanism and similarly wraps around and engages the pinion shaft 423, so that one of the pulley cables controls the left-right deflection of the distal portion 239 and the probe tip 240 and the other pulley cable controls the front / back deflection of the distal portion 239 and the probe tip 240.

[0042]

[0063] 10 is an isometric view of a portion of an example TEE probe mid-handle mechanism incorporating a pulley cable, in accordance with at least one embodiment of the present disclosure. In this view, the gear housing 410 is not shown so that the association of the pulley cable 925 with the shaft 425 can be seen. An additional crimped ball 920 in the middle of the cable 925 prevents the cable 925 from slipping around the shaft 425. If the control knob is rotated more than 180 degrees, multiple balls are crimped onto the Kevlar rope at the timing adjustment locations. The shaft 423 is also depicted.

[0043]

[0064] 11 is an isometric view of a portion of an example TEE probe mid-handle mechanism incorporating a pulley cable, in accordance with at least one embodiment of the present disclosure. This view provides details of a crimped ball or screw attachment 920. The crimped ball or screw attachment 920 is located midway through the pulley cable 923 and fits into a recess 1110 in the shaft 423 to prevent the pulley cable 923 from slipping relative to the shaft 423. Also depicted are the pulley cable 925, the gear housing 410, the three pull cable attachment assemblies 620, and the distal insulator 420.

[0044]

[0065] 12 is an isometric view of a portion of an example TEE probe mid-handle mechanism incorporating a pulley cable, in accordance with at least one embodiment of the present disclosure. This view includes shaft 423, which is flipped 180 degrees from the orientation of FIG. 11. Pulley cable 923 wraps around shaft 423 and is fastened to shaft 423 by crimped ball or screw attachment 920. Pulley cable 923 is attached to pull cable 333 via pull cable attachment assembly 620. The use of a fastened pulley cable allows shaft 423 to be a simple pulley shaft rather than a gear or pinion shaft, thereby reducing the material requirements, manufacturing tolerances, and geometric complexity of the part.

[0045]

[0066] 13 is an isometric exploded view of a portion of an example TEE probe mid-handle mechanism incorporating a timing belt, in accordance with at least one embodiment of the present disclosure. In a manner similar to the timing ladder of FIG. 8, timing belts 1323 and 1325 engage pinion shafts 423 and 425, such that rotation of either shaft causes linear motion of the corresponding timing belt, which in turn creates linear motion of pull cable attachment assembly 620 to move the corresponding pull cable 333 or 335. Brake switch 229 is also depicted, and due to its 3D shape, applies resistance to rotation of pinion shafts 423 and 425 when brake switch 229 is rotated to an engaged position, and allows shafts 423 and 425 to rotate when brake switch 229 is rotated to a disengaged position.

[0046]

[0067] In this embodiment, the containment frame 460 includes the distal insulator 420, the gear housing 410, and the header 1310. Also depicted is a floating non-rotating inner shaft 1340, which is between the inner pinion shaft 423 and the outer pinion shaft 425 for two-way articulation. The purpose of this shaft 1340 is to isolate motion that would otherwise be transferred from inside to outside or outside to inside during operation. This removes or nearly removes the cross-coupling of motion between the two control knobs. In one example, the floating shaft 1340 is mechanically restrained from rotating by a connection to the inner frame. The floating shaft 1340 is formed as part of the gear housing 410 or the base 730.

[0047]

[0068] In one example, portions of shafts 423, 425, and 1340 are disposed inside storage frame 460 and portions that are external to storage frame 460 are internal to control knobs 223 and 225 so that in a fully assembled device, they have minimal or no visibility. In one example, the timing belt is non-conductive. The timing belt is made of Kevlar, nylon, or an elastomeric compound molded over a metal reinforcement member to reduce stretch and increase life. The pull cable attachment assembly 620 is molded directly onto the timing belt, although the shape and materials of such an interface assembly are unique to each embodiment and include additional features such as screw tension adjustment.

[0048]

[0069] FIG. 14a is an isometric view of a portion of a mid-handle mechanism 399 of a conventional TEE probe that uses a rack and pinion mechanism to transfer motion from the control wheels to the pull cable. Visible are the control wheels 222 and 224, the brake switch 228, the gear housing 409, the distal insulator 419, the rack actuators 452 and 454, and the pull cable attachment assembly 619. The rack and pinion mechanism requires tight manufacturing tolerances to function properly and is therefore machined from steel, full hardened beryllium copper, or other metal. The brake switch 228 is also a multi-part assembly of four or more parts. The distal insulator is machined from a hard polymeric material such as glass-filled polycarbonate. The rack frame or gear housing comprises a fairly complex shape machined from a metal such as 6061-T6 aluminum.

[0049]

[0070] FIG. 14b is an isometric view of a portion of an exemplary TEE probe mid-handle mechanism 400 incorporating a timing belt, according to at least one embodiment of the present disclosure. Brake switch 229, pull cable 333, gear housing 410, pinion shafts 423 and 425, pull cable attachment assembly 620, header 1310, and timing belts 1323 and 1325 are visible. Those skilled in the art will appreciate that the assembly of FIG. 14b has a similar overall size and shape and operates in a similar manner as the assembly of FIG. 14a, but has a significantly simplified internal structure and fewer overall parts compared to those of FIGS. 4 and 14a, in accordance with the disclosure of FIGS. 6-13. For example, gear housing 410 and distal insulator 420 of containment frame 460 are formed as a single piece with fewer openings, through holes, threaded holes, and other complex features. The brake switch assembly is also unitary (i.e., formed as a single piece). Timing belts 1323 and 1325 each replace many components of a rack and pinion system, requiring significantly looser manufacturing tolerances, so that, for example, brake switch 229, pinion shafts 423 and 425, and containment frame 460 are quickly and inexpensively fabricated from cast or injection molded plastic, rather than machined from steel, aluminum, full hardened beryllium copper, glass-filled polycarbonate, or other metals or polymers, which would require significantly more time and cost. Depending on the implementation, some of these components continue to be fabricated from metal in areas where wear, fatigue, or stretching is a concern. For example, in some embodiments, the brake switch and pinion shaft are machined from metal.

[0050]

[0071] 15 is an isometric view of a portion of an exemplary TEE probe mid-handle mechanism 400 incorporating a timing belt in accordance with at least one embodiment of the present disclosure. This embodiment includes an assembly that is easier to manufacture and assemble than the current TEE probe mid-handle assemblies of FIGS. 4 and 14a. Visible in this view are control wheels 223 and 225, brake switch 229, pull cables 333 and 335, gear housing 410, distal insulator 420, pull cable attachment assembly 620, base 730, header 1310, timing belts 1323 and 1325, and several fasteners 1510.

[0051]

[0072] In one example, portions of shafts 423, 425, and 1340 are disposed inside storage frame 460 and portions that are external to storage frame 460 are internal to control knobs 223 and 225 such that in the fully assembled device, they appear minimally or not in view.

[0052]

[0073] FIG. 16 is an isometric view of a tape drive according to at least one embodiment of the present disclosure. In a manner similar to the timing belts and timing ladders previously disclosed, the tape drive converts the rotational motion of a gear with a shaft into linear motion of the tape. As with a timing belt or timing ladder, the tape incorporates the ability to engage teeth or other features of the gear, so that the tape does not slip relative to the gear and does not require friction as a means to rotate with the gear. Visible in this view are a gear 1610, a drive tape 1630, and a socket 1620 in which the shaft is placed. Incorporating a tape drive into a gear housing instead of a pulley cable, timing ladder, timing belt, or friction belt will be understood by those skilled in the art and provides one or more of increased material strength, reduced component stretch, comparable manufacturing efficiencies, and improved reliability and service life, for example, as compared to the friction belt, timing ladder, timing belt, and pulley cable designs described above. In one example, the drive tape 1630 is non-conductive.

[0053]

[0074] Figure 17 is an isometric view of a portion of an exemplary TEE probe mid-handle mechanism 400 incorporating a timing belt in accordance with at least one embodiment of the present disclosure. This view is similar to Figure 15, except that it includes outer handle casing 280, such as shown in Figure 2, to more fully convey the relationship of mid-handle mechanism 400 to the overall handle 120. Additionally, control wheels 223 and 225, brake switch 229, gear housing 410, distal insulator 420, pull cable attachment assembly 620, and timing belts 1323 and 1325 are visible.

[0054]

[0075] 18 is a detailed view of an example pull cable attachment assembly in accordance with at least one embodiment of the present disclosure. Two pull cable attachment assemblies 620 are visible, along with pulley cables 923 and 925 and fasteners 1510 that serve to connect the pulley cables 923 and 925 to the pull cable attachment assemblies 620.

[0055]

[0076] After becoming familiar with the teachings of the present specification, one of ordinary skill in the art will recognize that the disclosed TEE probe mid-handle assembly is, by definition, electrically insulated and provides a substantially less complex assembly that is easier and less costly to construct in production than existing TEE probe mid-handle assemblies.

[0056]

[0077] Those skilled in the art will also recognize that the above-described devices, systems, and methods may be modified in various ways. As a result, those skilled in the art will understand that the embodiments covered by the present disclosure are not limited to the specific exemplary embodiments described above. In that regard, while exemplary embodiments have been shown and described, the foregoing disclosure contemplates a wide range of changes, modifications, and substitutions. It will be understood that such modifications may be made to the foregoing without departing from the scope of the present disclosure. As a result, it is appropriate that the appended claims be construed broadly and consistent with the present disclosure.

Claims

1. A storage frame and A first control input arranged on the exterior of the storage frame; a first shaft disposed within the storage frame and coupled to the first control input; a first elongated flexible member including a first end and a second end, the first elongated flexible member wrapped around the first shaft; a first pull cable attachment coupled to the first end of the first elongated flexible member; a second pull cable attachment coupled to the second end of the first elongated flexible member; and a first pull cable attached to the first pull cable attachment; a second pull cable attached to the second pull cable attachment; 1. A transesophageal echocardiography probe comprising: actuation of the first control input causes the first shaft to rotate, resulting in linear movement of the first and second ends of the first elongated flexible member, thereby moving one of the first or second pull cables in a first direction and moving the other of the first or second pull cables in an opposite second direction; A transesophageal echocardiography probe, wherein a distal portion of a gastroscope coupled to the first and second pull cables is bent in accordance with movement of the first and second pull cables.

2. A second control input arranged outside the storage frame; a second shaft disposed within the storage frame and coupled to the second control input; a second elongated flexible member including a first end and a second end, the second elongated flexible member wrapped around the second shaft; a third pull cable attachment coupled to the first end of the second elongated flexible member; and a fourth pull cable attachment coupled to the second end of the second elongated flexible member; and a third pull cable attached to the third pull cable attachment; and a fourth pull cable attached to the fourth pull cable attachment; Further comprising: when the second control input is rotated, the second shaft rotates, causing the first and second ends of the second elongated flexible member to move linearly, thereby moving one of the third or fourth pull cables in the first direction and moving the other of the third or fourth pull cables in the opposite second direction; The transesophageal echocardiography probe of claim 1 , wherein the distal portion of the gastroscope coupled to the third and fourth pull cables is bent in accordance with movement of the third and fourth pull cables.

3. 3. The transesophageal echocardiography probe of claim 2, further comprising a unitary brake switch that, when rotated to a first position, applies resistance to rotation of the first and second shafts and, when rotated to a second position, allows the first and second shafts to rotate without resistance.

4. The transesophageal echocardiography probe of claim 3 , wherein at least one of the control input, the shaft, the elongated flexible member, the brake switch, or the containment frame is non-conductive.

5. The transesophageal echocardiography probe of claim 4 , wherein at least one of the control input, the shaft, the brake switch, or the housing frame is made of molded plastic.

6. The transesophageal echocardiography probe of claim 2 , wherein the first and second elongated flexible members are fabricated from an elastomeric compound that is molded over a nylon reinforcing member.

7. The transesophageal echocardiography probe of claim 2 , wherein the first control input directs anterior and posterior bending of the distal portion of the gastroscope and the second control input directs left / right bending of the gastroscope.

8. The transesophageal echocardiography probe of claim 2 , wherein the first and second elongated flexible members are frictional belts.

9. 3. The transesophageal echocardiography probe of claim 2, wherein the first and second shafts include gears or pinions, and the first and second elongated flexible members are timing ladder belts that engage the gears or pinions.

10. 3. The transesophageal echocardiography probe of claim 2, wherein the first and second shafts each include a socket, the first elongated flexible member is a pulley cable secured to the first shaft by a crimped ball or screw attachment that fits into the socket of the first shaft, and the second elongated flexible member is a pulley cable secured to the second shaft by a crimped ball or screw attachment that fits into the socket of the second shaft.

11. The transesophageal echocardiography probe of claim 2 , wherein the first and second shafts include gears or pinions, and the first and second elongated flexible members are timing belts that engage the gears or pinions.

12. The transesophageal echocardiography probe of claim 2 , wherein the first and second shafts include gears or pinions, and the first and second elongated flexible members are drive tapes that engage the gears or pinions.

13. The transesophageal echocardiography probe of claim 2 , wherein the pull cable attachment is formed directly on the elongated flexible member.

14. The transesophageal echocardiography probe of claim 2 , wherein the pull cable attachments each include a screw-type tensioning mechanism.

15. The transesophageal echocardiography probe of claim 2 , further comprising an outer handle casing.

16. The transesophageal echocardiography probe of claim 2 , wherein the first and second shafts are coaxial.

17. 3. The transesophageal echocardiography probe of claim 2, further comprising a floating, non-rotating, moving inner shaft affixed to the housing frame and positioned between the first and second shafts to limit mutual coupling of motion between the first and second shafts.

18. 1. A method for transesophageal echocardiography, the method comprising: Controlling bending of a distal portion of the gastroscope of the TEE probe based on an operation of a control input of the TEE probe, The TEE probe is Gastroscope and A storage frame and a handle assembly coupled to the gastroscope, the handle assembly including the control input, a shaft coupled to the control input, an elongated flexible member having a first end and a second end and around which the shaft is wrapped, a first pull cable attachment attached to the first end of the elongated flexible member, and a second pull cable attachment attached to the second end of the first elongated flexible member; a first pull cable attached to the first pull cable attachment and to a distal portion of the gastroscope; a second pull cable attached to the second pull cable attachment and to the distal portion of the gastroscope; Including, The step of controlling the bending further comprises: rotating the shaft coupled to the control input in response to manipulation of the control input; linearly moving the first pull cable attachment and the second pull cable attachment in response to rotating the shaft; linearly moving the first pull cable and the second pull cable in response to corresponding movement of the first pull cable attachment and the second pull cable attachment to cause bending of the distal portion of the gastroscope. controlling the bending, applying resistance to rotation of the shaft in response to rotation of a brake switch of the handle assembly to a first position; allowing rotation of the shaft without resistance in response to rotation of the brake switch to a second position; The method comprising:

19. 20. The method of claim 18, wherein at least one of the brake switch, the control input, the shaft, the elongated flexible member, the storage frame, the first pull cable attachment, or the second pull cable attachment are made of molded plastic.

20. Gastroscope and A control input section, a shaft coupled to the control input; an elongated flexible member wrapped around the shaft, the elongated flexible member including a first end and an opposite second end, the elongated flexible member including at least one of a friction belt, a timing ladder, a pulley cable, a timing belt, or a drive tape; a first pull cable attachment and a second pull cable attachment attached to the first end and the second end, respectively, of the elongated flexible member; and a unitary brake switch for selectively applying resistance to rotation of said shaft; a handle assembly coupled to the gastroscope, the handle assembly including: a first pull cable attached to the first pull cable attachment and to a distal portion of the gastroscope; for each elongated flexible member, a second pull cable attached to the second pull cable attachment and to the distal portion of the gastroscope; 1. A transesophageal echocardiography probe comprising: when the control input is actuated, the shaft rotates, which causes the first and second pull cable attachments to move linearly, and the first and second pull cables move linearly accordingly to bend the distal portion of the gastroscope; the unitary brake switch applies the resistance to the rotation of the shaft when rotated to a first position and allows the shaft to rotate without resistance when rotated to a second position; A transesophageal echocardiography probe, wherein at least one of the brake switch, the control input, the shaft, the elongated flexible member, the first pull cable attachment, or the second pull cable attachment are fabricated from molded plastic.

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