Actuators and related systems for medical devices

The actuator mechanism in medical devices with a rotatable disc and biasing member addresses the issue of wrist and hand discomfort by reducing the operational force, improving procedural efficiency and safety.

JP2026524922APending Publication Date: 2026-07-24BOSTON SCIENTIFIC SCIMED INC
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Patent Information

Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
BOSTON SCIENTIFIC SCIMED INC
Filing Date
2024-07-16
Publication Date
2026-07-24

AI Technical Summary

Technical Problem

Medical professionals experience wrist and hand discomfort due to the significant force required to activate actuators on medical devices, leading to fatigue and procedural inefficiencies.

Method used

A medical device with a handle featuring a housing and an actuator mechanism, including a rotatable disc and a biasing member, which reduces the force required to operate actuators by adjusting the length of the biasing member and using a lever to drive the disc's rotation, thereby minimizing the effort needed to manipulate the device.

Benefits of technology

The actuator mechanism reduces the force required to operate medical devices, alleviating wrist and hand discomfort, enhancing procedural efficiency, and reducing the risk of repetitive strain injuries.

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Abstract

We discuss medical devices and related methods, including a medical device comprising a handle having a housing and an actuator mechanism disposed within the housing. The actuator mechanism may include a biasing member and a disk rotatable between a first position and a second position, for example, the biasing member having a first length and exerting a first distal force on the disk at the first position, and having a second length different from the first length and exerting a second distal force on the disk at the second position that is smaller than the first distal force.
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Description

Technical Field

[0001] [Cross - Reference to Related Applications] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 513,961, filed Jul. 17, 2023, which is incorporated herein by reference in its entirety.

[0002] Various aspects of the disclosure generally relate to actuator mechanisms for medical devices. More specifically, embodiments of this disclosure relate to actuators for medical device handles, including a control assembly for providing a mechanical advantage, among other aspects.

Background Art

[0003] During a medical procedure, an operator can utilize a medical device that includes a handle and a shaft extending distally therefrom. For example, the medical device may be an endoscopic medical device. The shaft of the medical device may be inserted into the working channel of an endoscope (or other scope), advanced through the working channel, and extended out of the distal opening of the working channel at the distal tip of the endoscope. In addition to or instead of this, the shaft of the medical device can be inserted directly into the patient through, for example, an incision or a natural orifice. The operator can operate the medical device using the handle of the medical device. For example, the operator can activate an actuator at the handle. In one example, the actuator may include moving a knob.

[0004] Activating actuators on medical devices can sometimes require significant force. For example, during a medical procedure, a medical professional activating a medical device often wraps their entire palm around the grip or handle of the device and uses one or more of their fingers to access or activate various actuators on the device. Medical professionals may experience wrist and hand discomfort resulting from holding and manipulating the device's handle, from repetitive manual adjustments to access actuators, and / or activating actuators on the device. In some cases, medical professionals may experience symptoms similar to those of carpal tunnel syndrome, tenosynovitis, or De Quervain's tenosynovitis. [Overview of the Initiative] [Problems that the invention aims to solve]

[0005] If a healthcare professional experiences fatigue or other pain in their fingers, hands, or wrists, they may interrupt the procedure and / or shift from a primary grip position to a secondary grip position. Repeatedly stretching or bending fingers to access or activate various actuators on a device may increase fatigue or other pain. If a healthcare professional repeatedly readjusts their handgrip between procedural tasks, the procedure may become longer and the procedural task may become more difficult.

[0006] The systems and devices of this disclosure can correct some of the aforementioned shortcomings or address other aspects of the art. [Means for solving the problem]

[0007] The disclosure of the present invention includes, for example, a medical device comprising a handle having a housing and an actuator mechanism disposed within the handle. The actuator mechanism may include a disc and a biasing member, for example, the disc being rotatable between a first position and a second position. The proximal end of the biasing member may be coupled to the disc, and the distal end of the biasing member may be coupled to the housing. In some embodiments, at the first position of the disc, the biasing member has a first length and exerts or applies a first distal force on the disc, and / or at the second position of the disc, the biasing member has a second length different from the first length and exerts or applies a second distal force on the actuator that is smaller than the first distal force.

[0008] Any of the medical devices described herein may include any combination of the following features: The first length of the biasing member may be greater than the second length of the biasing member. In some examples, the disc includes a first projection on a first side of the disc and a second projection on a second side of the disc. The inner surface of the housing may accommodate the first projection on the first side of the handle and the second projection on the second side of the handle opposite the first side. The actuator mechanism may further include a lever coupled to the disc. For example, the lever may be coupled to the outer surface of the housing of the handle. The lever may be rotatable to drive the corresponding rotation of the disc.

[0009] In some examples, the biasing member can be fixed to the proximal portion of the disk. In addition to or instead of this, the actuator mechanism may further include first and second control members, each coupled to the disk. In some examples, the first control member is attached to the disk by a first coupler, the second control member is attached to the disk by a second coupler, and / or the biasing member is attached to the disk by a third coupler. The third coupler may be located between the first and second couplers. Movement of the disk from a first position to a second position is configured to move the first control member proximal and the second control member distal. Movement of the disk from a second position to a first position may be configured to move the first control member distal and the second control member proximal.

[0010] In some examples, the biasing member includes a spring. In some embodiments, at the third position of the disk, the biasing member acts a third distal force on the disk having a third length. The third distal force can be smaller than the first distal force. The disk may be rotatable in a first direction between the first and second positions, and / or rotatable in a second direction between the first and third positions.

[0011] In some examples, the medical device further includes a shaft coupled to a handle. The shaft may include articulated sections operably coupled to an actuator mechanism. Movement of the disc from a first position to a second position may be configured to move the articulated sections of the shaft along a first plane. Furthermore, for example, movement of the disc from a first position to a third position may be configured to move the articulated sections of the shaft across the first plane and along a second plane perpendicular thereto, for example.

[0012] The disclosure of the present invention also includes a medical device comprising a handle including a housing and an actuator mechanism disposed within the handle. The actuator mechanism may include a rotatable disk, a biasing member coupled to the disk and configured to act on the disk, a first control member coupled to the disk, and a second control member coupled to the disk. The handle may be configured to rotate from a first configuration to a second configuration by the rotation of the disk. In the second configuration, for example, the force acting on the disk is greater than the force acting on the disk in the second configuration. Rotation from the first configuration to the second configuration may shorten the length of the biasing member. The actuator mechanism may include a lever coupled to the disk, for example, the lever is configured to allow user interaction to drive the rotation of the disk. In some examples, a shaft is coupled to the handle. The shaft may include an articulated section operably coupled to the actuator mechanism. Movement of the disk may be configured to control the articulated section.

[0013] The disclosure of the present invention also includes a medical device comprising a handle comprising a housing and an actuator mechanism disposed within the housing. The actuator mechanism may include a disk rotatable between a first position and a second position, with a first control member coupled to the disk and a second control member coupled to the disk. The proximal end of the biasing member may be coupled to the disk, and the distal end of the biasing member may be coupled to the inner surface of the housing. The disk may include a first projection on a first side of the disk and a second projection on a second side. The housing may receive a first projection on a first side of the handle and a second projection on a second side of the handle opposite to the first side.

[0014] The accompanying drawings are incorporated into and constitute part of this application. These drawings illustrate aspects of the disclosure of the present invention that contribute to the commentary of this disclosure together with the description contained herein. Each drawing depicts one or more exemplary aspects of this disclosure as follows: [Brief explanation of the drawing]

[0015] [Figure 1] This is a diagram illustrating an exemplary medical device according to this disclosure.

[0016] [Figure 2] This figure shows a partial cross-sectional view of the medical device shown in Figure 1, according to this disclosure.

[0017] [Figure 3] This figure shows an exemplary force graph according to this aspect of disclosure.

[0018] [Figure 4A] This figure shows a portion of the control assembly of the medical device shown in Figure 1, according to this disclosure. [Figure 4B] This figure shows a portion of the control assembly of the medical device shown in Figure 2, according to this disclosure. [Modes for carrying out the invention]

[0019] Hereinafter, aspects of the disclosure of the present invention, illustrated in the accompanying drawings, will be referenced in detail below. Where possible, the same or similar reference numerals will always be used throughout the drawings to refer to the same or similar parts. The term “distal” refers to the part of the device furthest from the user when it is introduced into a subject (e.g., a patient). In contrast, the term “proximal” refers to the part of the device closest to the user when it is placed into a subject. The proximal and distal directions are labeled with arrows marked “P” and “D” respectively throughout the various drawings.

[0020] Both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the claimed features. As used herein, the terms "comprising," "having," "including," or other variations thereof are intended to cover a non-limiting inclusion such that a process, method, article, or apparatus that comprises, has, includes, or other variations thereof, the recited elements may include not only those elements but also elements not expressly recited or elements inherent to such process, method, article, or apparatus. In this disclosure, relative terms such as, for example, "about," "substantially," "generally," and "approximately" are used to indicate a possible variation of ±10% in the recited value or characteristic.

[0021] Although this specification discusses the treatment site as being within the gastrointestinal tract of a subject, the treatment site can be any lumen, organ, cavity, or other tissue within the body of the subject, and this disclosure is not so limited. Further, although this specification refers to an endoscope, it will be appreciated that this disclosure encompasses any medical device having an articulable distal end portion. In some examples, the medical device has an operating channel or lumen extending from a proximal end to a distal end. The medical device can include a ureteroscope, duodenoscope, gastroscope, endoscopic ultrasound ("EUS") scope, colonoscope, bronchoscope, laparoscope, arthroscope, cystoscope, swallowable endoscope, sheath, or catheter. In some examples, the medical device can include a handle and a shaft extending distally therefrom. The shaft of the medical device can be inserted into the operating channel of another medical device (e.g., an endoscope or other type of scope). Alternatively, the shaft of the medical device can be inserted directly into an incision, opening, or orifice of the subject. We have translated the text according to the rules, preserving the text tags, line breaks, and special placeholders. The translation is provided in English while maintaining the integrity of the original text structure.

[0022] Embodiments of the disclosure of the present invention can address one or more of the limitations of the art. However, the scope of the disclosure of the present invention is defined by the claims, rather than by the ability to solve a particular problem. The disclosure of the present invention relates, inter alia, to devices and systems for reducing the force required to deflect a portion of a medical device.

[0023] FIG. 1 depicts an exemplary medical device 100 that can include a handle 102 having a housing and an insertion portion / shaft 104 coupled thereto. The insertion portion 104 can be configured to be inserted into a subject. In some examples, at least a portion of the insertion portion 104 can be rigid or non-flexible. Alternatively, at least a portion of the insertion portion 104 can be flexible so that the insertion portion 104 can follow a tortuous path of a subject. In yet another example, the insertion portion 104 can include a combination of rigid and flexible portions and / or portions of various rigidities / flexibilities. For example, the distal portion 106 of the insertion portion 104 can have a higher flexibility than the proximal portion of the insertion portion 104. The proximal end of the insertion portion 104 can be coupled to the most distal end of the handle 102.

[0024] The handle 102 can be used to actuate and / or articulate the distal portion 106 of the insertion portion 104. The distal portion 106 can include a flexible portion, such as a joint section 107. The most distal end 108 of the distal portion 106 can include one or more imaging devices (e.g., imagers, lenses, cameras, etc.) and / or lighting devices (e.g., light emitting diodes, fiber optics, light bulbs, etc.). The most distal end 108 can include, in addition to or instead of, one or more openings. The openings can be in fluid communication with one or more lumens that extend through the insertion portion 104 and into the handle 102. For example, a port 110 disposed on the handle 102 can be in fluid communication with one or more openings of the most distal end 108.

[0025] For example, one or more auxiliary devices, such as a snare, basket, balloon, stent delivery system, forceps, stapler, needle, cauterization device, suturing device, drug delivery system, patch delivery system, or any other suitable medical device, may be inserted through port 110 and extend distally from an opening at the distal end 108. In addition to or instead of this, the opening at the distal end 108 may be configured to provide perfusion, suction, and / or blowing to the treatment site. The longitudinal axis L of the medical device 100 may extend along the proximal / distal direction of the medical device 100.

[0026] The handle 102 may include one or more actuators that can be activated or engaged by the user to control various aspects of the medical device 100. For example, the handle 102 may include a lever 112 that is operably coupled to an actuator mechanism within its housing. As shown in Figure 1, the lever 112 may be located in the proximal portion of the handle 102, for example, at or near the nearest end 113 of the handle 102. The lever 112 may include a knob or bar configured to be activated or engaged by the user. The lever 112 may be rotatable clockwise or counterclockwise around axis R, for example, in the direction indicated by the curved arrow in Figure 1. Axis R may be substantially perpendicular to the longitudinal axis L.

[0027] In some aspects of the disclosure of the present invention, the axis R may extend through a first projection 114A and a second projection 114B of an actuator mechanism including a disc 120 (see Figures 2, 4A, and 4B) within the handle 102. The first projection 114A may be located on a first side of the handle 102 (the side facing outward from the plane of the paper), and the second projection 114B may be located on a second opposite side of the handle 102 (for example, the side facing inward from the plane of the paper). The second projection 114B is not visible in the configurations shown in Figures 1 and 2, but is shown in Figure 4B, which will be discussed below.

[0028] The lever 112 can be operably coupled (e.g., directly or indirectly) to the disc 120 of the actuator mechanism. In this way, the rotation of the lever 112 drives the rotation of the corresponding disc 120. Thus, the disc 120 is rotated around the first projection 114A and the second projection 114B. In this way, the disc 120 can be made movable within the handle 102. Each of the first projection 114A and the second projection 114B extends completely or partially through each side of the handle 102, thereby retaining the disc 120 within the handle 102. Each of the first projection 114A and the second projection 114B (and thus the disc 120 and the lever 112) can be rotatable relative to the housing of the handle 102 but immovable proximal or distal to the housing of the handle 102. In some embodiments, the first projection 114A and / or the second projection 114B may extend through the handle 102 so that the user can see them on each side of the handle 102 (i.e., the side of the housing of the handle 102 facing outward from the plane of the paper and the side of the housing of the handle 102 facing inward from the plane of the paper).

[0029] In some examples, the first projection 114A and the second projection 114B are not visible to the user on either side of the housing of the handle 102. For example, the first projection 114A may extend completely through one side of the handle 102, and the second projection 114B may extend only partially through the other side of the handle 102, or vice versa. In this way, only one of the first projection 114A or the second projection 114B may be visible on the housing of the handle 102. In some examples, both the first projection 114A and the second projection 114B may extend only partially through each respective side of the handle 102, and therefore neither the first projection 114A nor the second projection 114B may be visible on either side of the housing of the handle 102.

[0030] In some embodiments, the handle 102 may include one or more internal or external feature portions molded complementary to the first projection 114A and / or the second projection 114B. For example, the handle 102 may include feature portions such as through holes, projections, recesses, or a combination thereof. In this way, the surface feature portions of the handle 102 can enable rotational movement of the disc 120 relative to the housing of the handle 102, while preventing axial or longitudinal movement of the disc 120 relative to the housing of the handle 102.

[0031] The shapes and relative sizes of the lever 112, the first projection 114A, the second projection 114B, and / or the handle 102 (e.g., the housing of the handle 102) shown in the figure are illustrative only, and other arrangements are considered within the disclosure of the present invention.

[0032] The lever 112 can be configured to be manually operated by an operator. For example, the lever 112 can be engaged by the operator's thumb and / or other fingers. In addition to or instead of this, the lever 112 can be engaged robotically or by indirect contact by the operator. In some examples, the lever 112 can be used to actuate the distal end 108 of the insertion portion / shaft 104. For example, the lever 112 can be directly or indirectly coupled to one or more control members 122 (shown in relation to Figure 2 and described in more detail). In this way, rotation of the lever 112 in a first direction (e.g., clockwise or counterclockwise) around the first projection 114A and the second projection 114B can articulate the distal end 108 in a first direction (e.g., up and down along a first plane). Rotation of the lever 112 in a second direction (e.g., counterclockwise or clockwise) around the first projection 114A and the second projection 114B allows the distal end 108 to articulate in a second direction different from the first direction (e.g., left or right along a second plane perpendicular to the first plane). When the lever 112 is in the neutral position (e.g., before the operator engages the lever 112), the distal end 108 can be oriented into a linear configuration, i.e., extending along the longitudinal axis L.

[0033] In addition to or instead of the above, the distal end 108 can be activated or started by moving the lever 112 in a first direction, and the distal end 108 can be stopped by moving the lever 112 in a second direction. For example, the opening of the distal end 108 can be opened by moving the lever 112 in a first direction, and the opening of the distal end 108 can be closed by moving the lever 112 in a second direction. In yet another example, the distal end 108 can be extended, retracted, deformed, or otherwise manipulated relative to its starting position relative to its neutral position by moving the lever 112 in a first or second direction.

[0034] The handle 102 may include one or more other actuators in the form of a controller 116 (e.g., a button, switch, knob, etc.). The controller 116 can be engaged by a user and is configured to control one or more aspects of the medical device 100. For example, the controller 116 may be configured to power an imaging device and / or illumination device / light source at the furthest end 108, provide suction and / or perfusion at the furthest end 108, capture or acquire video images and / or still images from an imaging device at the furthest end 108, lock the lever 112 in a certain position, adjust the intensity of an illumination device / light source at the furthest end 108, and so on.

[0035] A cable 118 (e.g., an umbilicus) can be fixedly or detachably coupled to the handle 102. For example, the cable 118 can be coupled to the distal portion 119 of the handle 102. The cable 118 can extend from the handle 102 to, for example, one or more auxiliary devices. One or more auxiliary devices may include, for example, a control system, an imaging system, a power supply, a fluid supply, a suction / vacuum source, a display, etc. In some examples, the cable 118 can be configured to supply power to the imaging device and / or illumination device / light source at the furthest end 108, and to transmit electrical signals from the imaging device at the furthest end 108 to the auxiliary devices.

[0036] During use, the handle 102 can be kept outside the subject's body so that it can be operated directly or indirectly by the operator. By engaging the lever 112 (for example, by moving the lever 112 in the first and / or second directions), the disc 120 (shown in Figure 2) can be rotated around the first projection 114A and the second projection 114B, thereby controlling one or more aspects of the distal portion 106 of the medical device 100. For example, during a medical procedure, the lever 112 can be used to control the articulated section 107 of the distal portion 106 of the insertion portion 104, articulate the end effector, open and close the jaws or blades, extend / retract the snare, needle, basket, or other device, deploy the medical instrument, staple tissue, cut tissue, and / or perform any other action. The insertion portion 104 of the medical device 100 can pass through one or more intricate internal lumens when used alone or with an endoscope or other type of microscope. An accessory device can be inserted through the port 110 of the handle 102, for example, through the lumen of the insertion portion / shaft 104, and the accessory device can extend distally past the most distal end 108 of the distal portion 106.

[0037] Figure 2 shows a partial cross-section of the handle 102. The handle 102 includes a proximal portion 102A, a distal portion 102C, and a central portion 102B. The proximal portion 102A can form the nearest end 113 of the handle 102, and the distal portion 102C can form the distal portion 119 of the handle 102. The central portion 102B can be located distal to the proximal portion 102A and proximal to the distal portion 102C.

[0038] In some examples, the proximal portion 102A and / or the distal portion 102C may have larger cross-sectional dimensions (e.g., width) than that of the central portion 102B. For example, the proximal portion 102A and / or the distal portion 102C may be wider than the central portion 102B. In some examples, the central portion 102B may be shaped to facilitate the operator's grip on the handle 102. The proximal portion 102A, the central portion 102B, and / or the distal portion 102C may include one or more additional features to facilitate the operator's grip on the handle 102. For example, one or more additional features on the proximal portion 102A, the central portion 102B, and / or the distal portion 102C may include surface features such as raised and / or recessed features, textures such as rough and / or smooth features, or any combination thereof, to facilitate the user's grip on the handle 102.

[0039] As discussed earlier, the shape and relative size of the handle 102 (e.g., the housing of the handle 102) shown in the figure are illustrative only, and other arrangements are considered within the disclosure of the present invention. For example, in other examples, each of the proximal portion 102A, the central portion 102B, and the distal portion 102C may have the same or similar cross-sectional dimensions (e.g., width). In this way, the handle 102 may have the same cross-sectional width along substantially its entire longitudinal length. For example, the proximal portion 102A may have the same width as the central portion 102B and the distal portion 102C.

[0040] The disc 120 can be located or enclosed within the housing of the handle 102, for example, within the proximal portion 102A of the handle 102. The lever 112 can be coupled to the disc 120 by mechanical fasteners (e.g., screws, press-fits, bolts, welds, rivets, etc.) (e.g., directly or indirectly). In some examples, the lever 112 is integrally formed with the disc 120. For example, the disc 120 can be a single molded component including the lever 112. The lever 112 can be located outside the housing of the handle 102, whereas the disc 120 can be enclosed, at least partially, within the housing of the handle 102. As discussed earlier, the disc 120 can be coupled to a first projection 114A, shown as a dashed circle in Figure 2, to allow for a clearer representation of it and other features of the actuator mechanism.

[0041] The proximal end of each of the one or more control members 122 (e.g., a first control member 122A and a second control member 122B) can be coupled to the disk 120 (e.g., directly or indirectly). As will be described in more detail below with respect to Figures 4A and 4B, each of the one or more control members 122 can be coupled to the proximal portion of the disk 120 near the first projection 114A and the second projection 114B. The proximal end of each of the one or more control members 122 can be coupled to the disk 120 by one or more mechanical fasteners (e.g., screws, bolts, ferrules, etc.), adhesives, welding, or any other suitable material.

[0042] The distal end of each control member 122 can also be coupled (for example, directly or indirectly) to the distal portion 106 (shown in Figure 1) of the insertion portion / shaft 104. For example, each control member 122 can extend distally through the handle 102 and the insertion portion 104 to the distal portion 106 (shown in Figure 1). Thus, when the lever 112 is moved in a first and / or second direction (for example, rotated clockwise or counterclockwise), each of the control members 122 can be translated proximal or distal. For example, when the lever 112 is rotated clockwise so that the disk 120 rotates around the first projection 114A and the second projection 114B, the first control member 122A is translated distally and the second control member 122B is translated proximal. The distal translation of the first control member 122A and the proximal translation of the second control member 122B can further activate or engage the distal portion 106 as described above with respect to Figure 1. For example, the distal translation of the first control member 122A and the proximal translation of the second control member 122B can bend the joint section 107 (shown in Figure 1) in a first direction.

[0043] Furthermore, when the lever 112 is rotated counterclockwise, the disc 120 rotates such that the first control member 122A is translated proximally and the second control member 122B is translated distally. The proximal translation of the first control member 122A and the distal translation of the second control member 122B can activate or engage the distal portion 106. For example, the proximal translation of the first control member 122A and the distal translation of the second control member 122B can bend the joint section 107 (shown in Figure 1) in a second direction.

[0044] The medical device 100 may further include, for example, a biasing member 123 (e.g., a spring, coil, elastic member, etc.) disposed within the handle 102 as part of an actuator mechanism. The proximal end of the biasing member 123 can be fixed at point A on the proximal portion of the disc 120, for example, proximal to the first projection 114A and the second projection 114B. The proximal end of the biasing member 123 can be fixed at point A by a mechanical fastener (e.g., a screw, set screw, bolt, rivet, etc.) and / or can be molded, overmolded, welded, or otherwise fixed onto the disc 120. The distal end of the biasing member 123 can be fixed at point B within the central portion 102B or distal portion 102C of the handle 102. For example, the distal end of the biasing member 123 can be fixed at point B on the inner surface or feature portion of the handle 102. Although not shown, the inner surface of the handle 102 may include features (e.g., projections or recesses) that can secure the distal end of the biasing member 123. The distal end of the biasing member 123 can be secured to the handle 102, for example, by mechanical fasteners (e.g., screws, set screws, bolts, rivets, etc.), adhesive, by molding it into the inner surface of the handle 102, by overmolding it, or by welding it. The location of point B in Figure 2 is illustrative only. For example, point B can be located more distally or more proximal within the handle 102, and / or lower (e.g., closer to the bottom of the page) or higher (e.g., closer to the top of the page) within the handle 102. The location of point B can be selected based on the desired tension applied to the disk 120 by the biasing member 123. For example, a more proximal placement may result in a weaker tension being applied to the disk 120 by the biasing member 123. Alternatively, a more distal arrangement can result in a stronger tension being applied to the disk 120 by the biasing member 123.

[0045] The biasing member 123 can be configured to at least partially balance the force applied to the disk 120 by each control member 122, thereby reducing such burden on the user / operator (e.g., a medical professional). As will be described in more detail below, the force required to move the lever 112 in the first and second directions can be reduced, and / or the biasing member 123 can be used to generate a smoother deflection sensation.

[0046] Figure 3 shows an illustrative graph of the force (solid line S) required to move the lever 112 in the first and second directions without the use of the biasing member 123. The force of the biasing member 123 acting on the disk 120 is illustrated by the dotted line B. The dashed line T shows the force required to move the lever 112 after the implementation of the biasing member 123. The Y-axis of the graph represents the force (e.g., force in pounds), and the X-axis represents the position of the lever 112 in degrees relative to the neutral position (e.g., zero-degree rotation), showing the force of the biasing member 123 acting on the disk 120 when the disk 120 is rotated in the first or second direction as described above. For example, the lever 112 can be moved in the first direction (e.g., clockwise) along the positive X-axis, and the lever 112 can be moved in the second direction (e.g., counterclockwise) along the negative X-axis.

[0047] As shown by line T in Figure 3, the force required to move the lever 112 in a first or second direction can be reduced by the implementation of the biasing member 123. In this way, the biasing member 123 can reduce the force required to move the lever 112 in a first and / or second direction, thereby helping to facilitate use by medical professionals. For example, when the lever 112 is in the neutral position, the biasing member 123 can be pulled more strongly than when the disc 120 is rotated in a first or second direction (e.g., clockwise or counterclockwise). The biasing member 123 may have a first length that allows the maximum distal force to be applied to the disc 120 in the neutral position. The distal force applied by the biasing member 123 to the disc 120 can help, for example, maintain the disc 120 in the neutral position without user intervention.

[0048] As the disc 120 rotates in the first and / or second directions, the biasing member 123 can be shortened, thereby reducing the tension within the biasing member 123. For example, as the disc 120 rotates in the first and / or second directions, the biasing member 123 can be shortened to have a second length shorter than its first length in the neutral position. Thus, as the disc 120 approaches its maximum rotation angle in the first or second direction, the distal force acting on the disc 120 by the biasing member 123 can be reduced. In other words, the biasing member 123 can substantially reduce the force required to move the lever 112.

[0049] The distal force applied to the disc 120 by the biasing member 123 can further assist in biasing the disc 120 in a first or second direction. For example, when the disc 120 is rotated so as not to remain in a neutral position, the biasing member 123 can act as a tensile force on the disc 120, thereby assisting in rotating the disc 120 toward the maximum rotation angle in the first and / or second direction. The distal force applied by the biasing member 123 can move the lever 112, thereby reducing the force required to rotate the disc 120. For example, since the biasing member 123 is applying a distal force to the disc 120, the operator can still achieve the desired joint movement of the distal portion 106 by the rotation of the disc 120 without having to apply so much force to the lever 112. In this way, the biasing member 123 can assist in rotating the disc 120, thereby achieving the deflection of the distal portion 106 of the insertion portion / shaft 104.

[0050] Furthermore, since the disc 120 can be secured on both sides of the handle 102, the oblique torque force associated with the force applied by the operator and / or other features of the medical device 100 can be reduced, thereby further reducing the force required to rotate the disc 120. In some examples, the oblique torque force can be induced by the operator applying an oblique force to the lever 112. The oblique force applied to the lever 112 may cause the disc 120 to be eccentric or offset from the longitudinal axis of the disc 120 which is parallel to the longitudinal axis L of the medical device 100. In addition to or instead of this, the oblique torque force may be associated by the design in which the disc 120 and the biasing member 123 are positioned in different planes.

[0051] Figures 4A and 4B show a side view (Figure 4A) and a top view (Figure 4B) of the disc 120. The disc 120 can be formed from a single component (e.g., a single molded component) or from two or more components joined together. In addition to or instead of this, the disc 120 may include a single material or two or more materials. The material may be lubricating, and / or the disc 120 may be coated with a lubricating material. The lubricating material may facilitate the rotation of the disc 120 in the handle 102, for example. As described above, the disc 120 is part of an actuator or actuator mechanism which also includes the lever 112, the first projection 114A, and the second projection 114B.

[0052] A plane P extending through the center of the disc 120 can divide the disc 120 into two sides, namely a first side 121A and a second side 121B. The first projection 114A and the second projection 114B can extend outward from the first side 121A and the second side 121B, respectively. In addition, the lever 112 can extend radially outward from the disc 120. The lever 112 may include one or more surface features 115 (e.g., projections, recesses, grips, etc.) to facilitate the operator's grip. One or more projections of the disc 120 can be hollow and / or solid.

[0053] The disk 120 may include a first cylindrical portion 120C. The first cylindrical portion 120C may include a first wall 124, a second wall 126, and a third wall 128. The first wall 124 may be parallel to the second wall 126. The third wall 128 may extend between the first wall 124 and the second wall 126. The lever 112 may extend radially outward from the third wall 128. In some examples, each of the first wall 124, the second wall 126, and the third wall 128 may be substantially flat or planar.

[0054] In some examples, the first wall 124 and / or the second wall 126 may include one or more protrusions and / or recesses configured to restrict the rotational movement of the disc 120 relative to the housing of the handle 102. For example, the protrusions and / or recesses can abut against or engage with corresponding feature portions on the inner surface of the housing of the handle 102 to suppress or prevent the disc 120 from rotating past a predetermined position. In this way, these feature portions can contribute as stops.

[0055] In some embodiments, the third wall 128 can be curved, for example, like a wheel or disc (curved outward) or a guide wheel (curved inward). The handle 102 may include complementary features that accommodate the curvature of the third wall 128. For example, the handle 102 may include an inwardly curved feature that fits into or abuts against the outwardly curved surface of the third wall 128. The inwardly curved feature of the handle 102 can assist in aligning the disc 120 within the handle 102. Similarly, the handle 102 may include an outwardly curved feature that fits into or abuts against the inwardly curved surface of the third wall 128 of the disc 120. In such an example, the outwardly curved feature of the handle 102 can assist in aligning the disc 120 within the handle 102. The handle 102 (e.g., the housing of the handle 102) may include additional features that maintain the position of the disc 120 within the handle 102 or assist in aligning the disc 120 within the handle 102.

[0056] The first side 121A of the disk 120 may include a first feature portion 130 extending outward along axis R from the first wall 124 of the first cylindrical portion 120C. For example, the central axis of the first feature portion 130 can be aligned with the central axis of the first cylindrical portion 120C so that the first feature portion 130 is concentric with the first cylindrical portion 120C. The first feature portion 130 can be molded similarly to or complementary to the first cylindrical portion 120C. For example, the first feature portion 130 can be molded to be cylindrical, similar to the first cylindrical portion 120C. Alternatively, the first feature portion 130 can be square or rectangular. The diameter of the first feature portion 130 can be smaller than the diameter of the first cylindrical portion 120C. The height of the first feature portion 130 (for example, the dimension measured from the first wall 124 of the first cylindrical portion 120C to the outer wall 132 of the first feature portion 130) can be equal to, less than, or greater than the height of the first cylindrical portion 120C (for example, the dimension measured from the first wall 124 to the second wall 126 of the first cylindrical portion 120C). The first feature portion 130 can be hollow or solid. The first feature portion 130 can be sized and / or molded to accommodate the internal feature portion or contour of the handle 102. For example, the first feature portion 130 can be sized and / or molded to reduce the size of the handle 102.

[0057] The second feature portion 134 may extend from the outer wall 132 of the first feature portion 130, and the first projection 114A may extend outward from the outer wall 136 of the second feature portion 134. Similar to the first feature portion 130, the central axes of the second feature portion 134 and the first projection 114A can be aligned with the central axis and axis R of the first feature portion 130 so that the second feature portion 134 and the first projection 114A are concentric with respect to each other and with respect to the first feature portion 130. The second feature portion 134 may be molded in the same way as or complementary to the first feature portion 130. The first projection 114A may be molded in the same way as the second feature portion 134.

[0058] The second feature portion 134 and / or the first projection 114A may have any or all of the same characteristics as the first feature portion 130 described above. For example, the second feature portion 134 and / or the first projection 114A may be molded in a cylindrical shape, similar to the first feature portion 130. Alternatively, the second feature portion 134 may be square or rectangular. The diameter of the second feature portion 134 may be smaller than the diameter of the first feature portion 130 and / or the first cylindrical portion 120C. The diameter of the first projection 114A may be smaller than the diameter of the second feature portion 134. The height of the second feature portion 134 (for example, the dimension measured from the outer wall 132 of the first feature portion 130 to the outer wall 136 of the second feature portion 134) can be smaller than the height of the first feature portion 130 (for example, the dimension measured from the first wall 124 of the first cylindrical portion 120C to the outer wall 132 of the first feature portion 130). Alternatively, the height of the second feature portion 134 can be greater than or equal to the height of the first feature portion 130. In addition to or instead of this, the height of the first projection 114A can be less than, greater than, or equal to the height of the second feature portion 134 and / or the height of the first feature portion 130.

[0059] The first side 121A of the disk 120 may include one or more additional elements between the second feature portion 134 and the first projection 114A. The additional elements may have a gradually decreasing diameter. In addition, the additional elements may have different or the same height. For example, an additional element (not shown) that abuts the outer wall 136 of the second feature portion 134 may have a smaller diameter and height than that of the second feature portion 134. Alternatively, a third feature portion (not shown) may have a smaller diameter and greater height than that of the second feature portion 134. Many other configurations are also possible.

[0060] Optionally, the first feature portion 130 and / or the second feature portion 134 may be omitted, and thus the first projection 114A may extend directly from the first wall 124 of the first cylindrical portion 120C or from the outer wall 132 of the first feature portion 130.

[0061] The second side 121B of the disk 120 may include a plate 140. The first coupler 142, the second coupler 144, and the third coupler 146 may extend outward from the second wall 126 between the first cylindrical portion 120C and the plate 140, for example, away from the central plane P. For example, each of the first coupler 142, the second coupler 144, and the third coupler 146 may extend between the second wall 126 and the inner wall 148 of the plate 140. In this way, the first coupler 142, the second coupler 144, and the third coupler 146 separate the first cylindrical portion 120C and the plate 140, creating a gap 147. Each of the first coupler 142 and the second coupler 144 may be configured to receive a first control member 122A and a second control member 122B, respectively. The first control member 122A, the second control member 122B, and the biasing member 123 extend between the first cylindrical portion 120C and the plate 140, for example, through a gap 147. In some examples, the plate 140 can be configured to provide a barrier between the first control member 122A, the second control member 122B, and the biasing member 123 and other aspects of the handle 102. For example, the plate 140 can help prevent the first control member 122A, the second control member 122B, and the biasing member 123 from becoming entangled with or interfering with the internal features of the handle 102 during use.

[0062] Each of the first coupler 142, the second coupler 144, and the third coupler 146 can be columnar. The third coupler 146 can be positioned between the first coupler 142 and the second coupler 144. In some examples, portions of the first coupler 142 and / or the second coupler 144 can extend beyond the outer edge or periphery of the plate 140. In some examples, the first coupler 142, the second coupler 144, and the third coupler 146 can be oriented toward each other in a substantially triangular shape (with the third coupler 146 forming a vertex proximal to the vertices formed by the first coupler 142 and the vertices formed by the second coupler 144), for example, as shown in Figures 2 and 4A. Other arrangements are considered herein.

[0063] The first coupler 142 and the second coupler 144 can be configured to receive the first control member 122A and the second control member 122B, respectively (see Figure 2). In some examples, the first control member 122A can be coupled to the first coupler 142, and the second control member 122B can be coupled to the second coupler 144. For example, the first control member 122A and the second control member 122B can be wrapped around, tied to, molded into, or otherwise coupled to the first coupler 142 and the second coupler 144, respectively. In some examples, the first coupler 142 can include a first through-hole 150, and / or the second coupler 144 can include a second through-hole 152. The first control member 122A and the second control member 122B can extend through the first through-hole 150 and / or the second through-hole 152, respectively. In addition to or instead of the above, each of the first through-hole 150 and the second through-hole 152 may be sized and / or molded to receive one or both proximal ends of the first control member 122A and the second control member 122B. In some examples, each of the first through-hole 150 and the second through-hole 152 may be sized and / or molded to receive ferrules coupled to the respective proximal ends of the first control member 122A and the second control member 122B.

[0064] The third coupler 146 may be configured to receive a biasing member 123 (shown in Figure 2). In some examples, the biasing member 123 may extend between the first coupler 142 and the second coupler 144 and connect to the third coupler 146. For example, the biasing member 123 may be wrapped around, tied to, molded into, or otherwise bonded to the third coupler 146. Alternatively, the third coupler 146 may include a third through-hole 154. The third through-hole 154 may be sized and / or molded to receive the proximal end of the biasing member 123. For example, the proximal end of the biasing member 123 may extend through the third through-hole. The central axis of the third coupler 146 may be aligned with point A shown in Figure 2.

[0065] In some examples, one or more of the first coupler 142, the second coupler 144, or the third coupler 146 may be offset from or from each other. In the exemplary configuration, the axis between the center point of the first coupler 142 and the center point of the second coupler 144 does not intersect the axis passing through the center point of the third coupler 146. Optionally, the first coupler 142 and the second coupler 144 may extend in parallel planes. In some examples, each of the first coupler 142, the second coupler 144, and the third coupler 146 may be positioned such that all couplers are located on or around the upper or lower portion of the second side 121B of the disk 120. For example, each of the first coupler 142, the second coupler 144, and the third coupler 146 may be positioned above or on the first side of the horizontal or transverse plane H of the disk 120.

[0066] The central axis of plate 140 can be aligned with the central axis of the first cylindrical portion 120C so that plate 140 is concentric with the first cylindrical portion 120C. Plate 140 can be molded similarly to or complementary to the first cylindrical portion 120C. For example, plate 140 can be molded to be cylindrical, similar to the first cylindrical portion 120C. The diameter of plate 140 can be smaller than the diameter of the first cylindrical portion 120C. In some embodiments, the diameter of plate 140 can be equal to the diameter of the first feature portion 130 discussed above. In some configurations, the diameter of plate 140 can be smaller or larger than the diameter of the first feature portion 130.

[0067] The fourth feature portion 156 may extend from the outer wall 158 of the plate 140, and the second projection 114B may extend outward from the outer wall 160 of the fourth feature portion 156. Similar to the plate 140, the central axes of the fourth feature portion 156 and the second projection 114B can be aligned with the central axis and axis R of the first cylindrical portion 120C. In this way, the fourth feature portion 156 and the second projection 114B can be concentric with respect to each other and with respect to the first cylindrical portion 120C. The fourth feature portion 156 may be molded similarly to or complementary to the plate 140. The second projection 114B may be molded similarly to the fourth feature portion 156. For example, the fourth feature portion 156 and / or the second projection 114B may be molded cylindrically, similar to the plate 140. The diameter of the fourth feature portion 156 may be smaller than the diameter of the plate 140. The diameter of the second projection 114B can be smaller than the diameter of the plate 140.

[0068] The height of the fourth feature portion 156 (for example, the dimension measured from the outer wall 158 of plate 140 to the outer wall 160 of the fourth feature portion 156) can be smaller than the height of plate 140 (for example, the dimension measured from the inner wall 148 of plate 140 to the outer wall 158 of plate 140). Alternatively, the height of the fourth feature portion 156 can be greater than or equal to the height of plate 140. In addition to or instead of this, the height of the second projection 114B can be less than, greater than, or equal to the height of plate 140 and / or the height of the fourth feature portion 156.

[0069] In some cases, the first side 121A and the second side 121B can be mirror images of each other. For example, the second side 121B of disk 120 may have each of the features described above with respect to the first side 121A (e.g., the first feature 130, the second feature 134, etc.). Alternatively, the first side 121A of disk 120 may have each of the features described above with respect to the second side 121B (e.g., the plate 140, the fourth feature 156, the first coupler 142, the second coupler 144, the third coupler 146, etc.). Having the same features on each side of disk 120 can help reduce the complexity and / or cost of manufacturing disk 120.

[0070] As discussed earlier, the disk 120 can be housed within the housing of the handle 102. For simplicity, the handle 102 is shown as a dashed square box in Figure 4B; see also Figures 1 and 2. The handle 102 may include one or more openings, notches, recesses, etc., configured to receive the first projection 114A and the second projection 114B, respectively. In some examples, each of the first projection 114A and the second projection 114B may extend beyond the housing of the handle 102 (e.g., the outermost surface of the handle 102).

[0071] The first dimension H1 can be measured from the first wall 124 to the handle 102 on the first side 121A of the disc 120. The second dimension H2 can be measured from the second wall 126 to the handle 102 on the second side 121B of the disc 120. The first dimension H1 can be equal to the second dimension H2. In this way, the disc 120 can be centered within the handle 102. Centering the disc 120 within the handle 102 can help prevent the disc 120 from becoming eccentric within the handle 102 and / or prevent the generation of oblique forces.

[0072] While this specification has described the principles of the disclosure of the present invention with reference to exemplary embodiments relating to specific medical procedures, the disclosure of the present invention is not limited to these embodiments. Those skilled in the art and those who can utilize the teachings provided herein will recognize additional modifications, uses, embodiments, and substitutions of equivalents that all fall within the scope of the embodiments described herein. Therefore, the disclosure of the present invention should not be considered to be limited by the foregoing description. [Explanation of Symbols]

[0073] 102 Handle 112 Lever 116 Controllers 120 discs 123 Biasing member D Distal direction

Claims

1. It is a medical device, A handle including a housing and an actuator mechanism disposed within the housing, Includes, The actuator mechanism is A disk rotatable between a first position and a second position, and A biasing member wherein the proximal end of the biasing member is coupled to the disk and the distal end of the biasing member is coupled to the housing, Includes, At the first position of the disk, the biasing member has a first length and exerts a first distal force on the disk. At the second position of the disk, the biasing member has a second length different from the first length and exerts a second distal force on the disk that is smaller than the first distal force. Medical devices.

2. The medical device according to claim 1, wherein the first length of the biasing member is greater than the second length of the biasing member.

3. The medical device according to claim 1 or 2, wherein the disk includes a first projection on the first side of the disk and a second projection on the second side of the disk.

4. The medical device according to claim 3, wherein the inner surface of the housing receives the first projection on the first side of the handle and the second projection on the second side of the handle opposite to the first side.

5. The medical device according to any one of claims 1 to 4, wherein the actuator mechanism further includes a lever coupled to the disk.

6. The medical device according to claim 5, wherein the lever is coupled to the outer surface of the housing of the handle, and the lever is rotatable to drive the corresponding rotation of the disk.

7. The biasing member is fixed to the proximal portion of the disk, according to any one of claims 1 to 6.

8. The medical device according to any one of claims 1 to 7, wherein the actuator mechanism further includes a first control member and a second control member, each coupled to the disk.

9. The first control member is attached to the disk by a first coupler. The second control member is attached to the disk by a second coupler. The biasing member is attached to the disc by a third coupler. The medical device according to claim 8, wherein the third coupler is located between the first coupler and the second coupler.

10. The movement of the disk from the first position to the second position is configured to move the first control member proximal and the second control member distal, The medical device according to claim 8 or 9, wherein the movement of the disk from the second position to the first position is configured to move the first control member distally and the second control member proximal.

11. The biasing member includes a spring, according to any one of claims 1 to 10.

12. The medical device according to any one of claims 1 to 11, wherein at the third position of the disk, the biasing member has a third length and exerts a third distal force on the disk, and the third distal force is smaller than the first distal force.

13. The medical device according to claim 12, wherein the disk is rotatable in a first direction between the first position and the second position, and rotatable in a second direction between the first position and the third position.

14. The medical device further includes a shaft coupled to the handle, The medical device according to any one of claims 1 to 13, wherein the shaft includes a joint section operably coupled to the actuator mechanism.

15. The medical device according to claim 14, wherein the movement of the disk from the first position to the second position is configured to move the joint section of the shaft along a first plane, and the movement of the disk from the first position to the third position is configured to move the joint section of the shaft along a second plane perpendicular to the first plane.