Medical devices and related systems and methods

Abstract

A handle assembly (106) for a medical device is disclosed. The handle assembly may include a handle body (320) including a first central longitudinal axis; a first connector portion (321) coupled to the distal end of the handle body; and a shaft (308) extending distally from the first connector portion, wherein a second central longitudinal axis of the shaft is offset from the first central longitudinal axis of the handle body.

Description

Technical Field

[0001] Various aspects of the present disclosure generally relate to handles for medical devices. More specifically, embodiments of the present disclosure relate to handles for endoscopes or other medical devices, including endoscopes or other medical devices having offset handle and shaft axes. Background Art

[0002] During an endoscopic examination, a medical professional operating an endoscope typically wraps the entire palm of their hand around the grip or handle portion of a medical device such as an endoscope. Various actuators on the handle of an endoscope require medical personnel to twist their hands for long periods of time and frequently during the examination, which may cause strain or even injury. In some cases, activating different endoscope controls (such as knobs or lifters) may cause excessive movement of the thumb or other fingers of the medical professional, which may cause hand strain in the medical professional. Endoscope operators may experience discomfort in their wrists and hands when holding and manipulating the handle of an endoscope. In some cases, for example, medical personnel may experience symptoms similar to carpal tunnel syndrome or tendonitis. When medical personnel feel fatigue or other pain in their fingers, hands, or wrists, the medical personnel may switch from a primary grip position to a secondary grip position, which may not have as good a grip as the primary grip position, such as switching from a four-finger grip to a three-finger grip. Repeatedly bending and moving the wrist to adjust the position of the endoscope can increase fatigue or other pain.

[0003] When medical personnel repeatedly adjust their hand grip between surgical tasks, surgical procedures may be prolonged and surgical tasks may become more difficult. Depending on the size of the medical personnel's hands, the actuators may be placed in non-optimal positions and increase the number of hand adjustments during the surgical procedure. Summary of the invention

[0004] Aspects of the present disclosure relate to systems, devices, and methods to help reduce stress on a user's hand during operation of a handle assembly. The systems, devices, and methods of the present disclosure can facilitate a user's hand gripping an endoscope or other medical device. Endoscopes and other medical devices having a handle that can rotate relative to a proximal shaft portion can help address user hand fatigue or strain, can help reduce the need for re-grip adjustment, and can help address other issues. Each aspect disclosed herein may include one or more features related to any other disclosed aspect.

[0005] According to one aspect, a handle assembly for a medical device is disclosed. The handle assembly may include: a handle body including a first central longitudinal axis; a first connector portion coupled to a distal end of the handle body; and a shaft extending distally from the first connector portion, wherein a second central longitudinal axis of the shaft is offset from the first central longitudinal axis of the handle body.

[0006] In other aspects, the handle assembly may include one or more of the following features. The second connector portion may be coupled to (i) the proximal end of the shaft and (ii) the first connector portion, and the second connector portion may be spaced apart from the first central longitudinal axis of the handle body. The shaft may also include a distal tip and a camera located at the distal tip. The first inner chamber of the handle body may be in communication with the second inner chamber of the first connector portion. The internal assembly may extend longitudinally through the first inner chamber and the second inner chamber. The shaft may include a stress relief portion located at the proximal portion of the shaft. The first connector portion may include a working channel port. At least a portion of the first connector portion may extend from a first side of the handle body to a second side of the handle body, and may protrude radially outward from the second side of the handle body. The first connector portion may include a planar surface facing the proximal side. The handle body may include (a) a suction actuator and (b) an air and water actuator. The handle body may include a first control knob, a second control knob, a locking rod, and a locking knob. The central longitudinal axis of the handle body may be substantially parallel to the central longitudinal axis of the shaft. The second connector portion may extend into (i) the first connector portion and (ii) the shaft. The connector may be rectangular. The central longitudinal axis of the handle body may be approximately 68 millimeters from the central longitudinal axis of the shaft.

[0007] In other aspects, a handle assembly for a medical device may include: a handle body comprising a central longitudinal axis; a first connector portion coupled to a distal end of the handle body; a second connector portion coupled to a distal portion of the first connector portion, located completely distal to the handle body, and spaced apart from the handle body; and an axis extending distally from the second connector portion, wherein the central longitudinal axis of the axis is spaced apart from the central longitudinal axis of the handle body.

[0008] In other aspects, the handle assembly may include one or more of the following features. The handle assembly may be configured to be held by a user so that the user's wrist is aligned with the central longitudinal axis of the shaft. The central longitudinal axis of the handle body may be substantially parallel to the central longitudinal axis of the shaft. The handle body may include a first control knob, a second control knob, a locking lever, and a locking knob.

[0009] In other aspects, a method of operating an endoscope including a handle is disclosed. The method may include moving a handle body in a circumferential direction around a central longitudinal axis of an endoscope shaft. A user's wrist is aligned with the central longitudinal axis of the shaft; and the handle body is spaced apart from the central longitudinal axis of the shaft.

[0010] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary aspects of the disclosure and, together with the description, serve to explain the principles of the disclosure.

[0012] Figure 1A and 1B is a perspective view of an exemplary endoscope according to aspects of the present disclosure.

[0013] Figure 2A and 2B According to aspects of the present disclosure, a user's hand holds an endoscope handle (eg Figure 1A and 1B A stereoscopic view of the handle of an endoscope.

[0014] Figure 3 is a side view of a portion of an endoscope including a handle assembly according to aspects of the present disclosure.

[0015] Figure 4 is a side view of a portion of an endoscope including a handle assembly, with certain transparent portions to show internal structures, according to aspects of the present disclosure.

[0016] Figure 5 According to aspects of the present disclosure, Figure 3 and Figure 4 A side partial cross-sectional view of a portion of a handle assembly. DETAILED DESCRIPTION

[0017] Reference will now be made in detail to aspects of the present disclosure, examples of which are shown in the accompanying drawings. Whenever possible, the same or similar reference numbers will be used in the accompanying drawings to refer to the same or similar parts. The term "distal" refers to the part farthest from the user when the device is introduced into the patient's body. In contrast, the term "proximal" refers to the part closest to the user when the device is placed into the patient's body. In the various figures contained in this application, arrows marked with "P" and "D" are used to show the proximal and distal directions in the figures. As used herein, the terms "include", "comprise" or any other variant thereof are intended to cover non-exclusive inclusion, so that the process, method, article or device containing a list of elements includes not only those elements, but also other elements that are not explicitly listed or inherent in such processes, methods, articles or devices. The term "exemplary" is used as an "example" rather than an "ideal" meaning. In addition, relative terms such as "approximately", "substantially", "approximately", etc. are used to indicate that the numerical value or range may vary by ±10%.

[0018] Embodiments of the present disclosure are directed to improving a user's ability to grasp, manipulate, and / or otherwise apply force to a handle and handle actuator of a medical device (e.g., an endoscope) during a medical procedure. As non-limiting exemplary advantages, aspects of the present disclosure may reduce the need to reposition a user's hand during a procedure, reduce stress on a user's hand caused by excessive finger movement, etc.

[0019] Figure 1A and 1B A perspective view of an exemplary endoscope system 100 is shown. Endoscope system 100 may include endoscope 101. Although the term "endoscope" may be used herein, it is understood that other devices, including but not limited to duodenoscopes, colonoscopes, ureteroscopes, bronchoscopes, laparoscopes, sheaths, catheters, or any other suitable delivery device or other type of medical device, may be used in conjunction with the devices of the present disclosure, and the handle assembly discussed below may be incorporated into any of these or other medical devices.

[0020] Endoscope 101 may include a handle assembly 106 and a flexible tubular shaft 108. Handle assembly 106 may include a biopsy port 102, a biopsy cover 103, an image capture button 104, a lift actuator 107, a locking rod 109, a locking knob 110, a first control knob 112, a second control knob 114, a suction button 116, an air / water button 118, a handle body 120, and an umbilicus 105. All actuators, lifters, knobs, buttons, rods, ports, or covers of endoscope system 100 (such as those listed above) may be used for any purpose and are not limited to any specific use implied by the respective names of each component used herein. Umbilicus 105 may extend from handle body 120 to auxiliary devices, such as a control unit, a water / fluid supply source, and / or a vacuum source. Umbilicus 105 may transmit signals between endoscope 101 and a control unit to control the illumination and imaging components of endoscope 101 and / or receive image data from endoscope 101. The umbilicus 105 may also provide fluid for irrigation to the distal tip 119 of the shaft 108 from a water / fluid supply and / or a suction source. Buttons 116 and 118 control valves for suction and fluid supply (e.g., air and water), respectively. The shaft 108 may terminate at the distal tip 119. The shaft 108 may include a hinged portion 122 for deflecting the distal tip 119 upward, downward, leftward, and / or rightward. Knobs 112 and 114 may be used to control such deflection, and locking rods 109 and locking knobs 110 may lock knobs 112 and 114 in desired positions, respectively. The handle body 120 may be tapered and may narrow as the handle extends distally, so that the profile of the handle body 120 is smaller at its distal end than at its proximal end.

[0021] The distal tip 119 may include an imaging device (e.g., a camera) and an illumination source (e.g., an LED or fiber optic). The distal tip 119 may face sideways. That is, the imaging device and the illumination source may be radially outward, perpendicular, approximately perpendicular, or otherwise transverse to the longitudinal axis of the shaft 108 and the distal tip 119. In an alternative, the distal tip 119 may face forward. That is, the imaging device and the illumination device may face generally along the longitudinal axis of the distal tip 119 and the shaft 108.

[0022] When operating the endoscope system 100, the user can hold the handle assembly 106 (eg, Figure 2A 106, such as the first and second control knobs 112, 114 and the locking lever 109 and the locking knob 110. The user can grasp the handle assembly 106 by wrapping his hand around the handle body 120. While grasping the handle body 120, the user can operate the first and second control knobs 112, 114 and the lifting actuator 107 with the left thumb (by rotating about their respective axes), and can operate the image capture button 104, the suction button 116 and / or the air / water button 118 (each by pressing) with the fingers of the left hand.

[0023] Figure 2A and 2B An exemplary user's left hand 201 is shown grasping the handle assembly 106, which may have a central longitudinal axis 199 extending longitudinally through the handle assembly 106. The user may position the thumb 202 of the left hand 201 (gripping hand) over the lift actuator 107 and move the lift actuator 107 from a first position (e.g., Figure 2A as shown) moves to a second position (as shown) Figure 2B shown). Figure 2A An axis 279 is shown that is aligned with the radioulnar joint axis, or the axis about which the hand 201 rotates when the user moves the wrist. For example, the user can rotate the axis 108 by bending the wrist, thereby rotating the handle assembly 106. The handle assemblies discussed in the present disclosure can facilitate gripping the handle, can reduce stress on the user's hand when repositioning the medical device, and can facilitate the user to use the hand and wrist to rotate the medical device.

[0024] like Figure 3A perspective view of an alternative handle assembly 300 is shown, which includes a locking lever 309, a locking knob 310, a first control knob 312, a second control knob 314, a handle body 320, and a shaft 308. The handle assembly 300 can include any of the features of the handle assembly 106. The distal portion 370 of the handle body 320 can be coupled to the first connector portion 321. The first connector portion 321 can include a working channel port 302 having a working channel opening 303. The proximal end 373 of the second connector portion 322 can be coupled to the distal portion 374 of the first connector portion 321, and the shaft 308 can include a stress relief portion 376. The handle body 320 can have a central longitudinal axis 341, and the shaft 308 can have a central longitudinal axis 342 that is offset from the axis 341 of the handle body 320. In some embodiments, the handle body 320 can have a central longitudinal axis 342 that is offset from the axis 341 of the handle body 320. For example, axis 341 can be substantially parallel to axis 342. Axis 341 can be spaced apart from axis 342 by approximately 68 millimeters.

[0025] The offset of the handle body 320 from the shaft 308 (i.e., the offset of the axis 341 from the axis 342) can facilitate the user to apply torque to the shaft 308 by moving the handle body 320. In some examples, when the user holds the handle body 320, the user's radioulnar joint axis 279 can be substantially aligned (i.e., substantially coaxial) with the central longitudinal axis 342 of the shaft 308, which can facilitate the rotation of the shaft 308 about the axis 342 when the user bends the wrist. When the shaft 308 rotates about the axis 342, the handle body 320 can move in a circumferential direction about the axis 342. In other words, the first connector portion 321 and the handle body 320 can pivot about the axis 342.

[0026] At least a portion of the first connector portion 321 can extend from a first side 380 of the handle body 320 to a second side 381 of the handle body 320 across the distal portion 370 of the handle body 320 and protrude radially outward from the second side 381 relative to the axis 341. For example, a distal end of the proximal end 383 of the first connector portion 321 can be substantially planar and can abut the distal portion 370 of the handle body 320. The proximal end 282 can include a proximally facing planar surface. In some examples, the first connector portion 321 can include a first half and a second half that are fastened together to form the first connector portion 321.

[0027] The working channel port 302 can be adjacent to the first side 380 of the handle body 320 and can be spaced apart from the second connector portion 322. Figure 5As further discussed, a portion of the second connector portion 322 can be received within the first connector portion 321. The shaft 308 can include a strain relief portion 376 coupled to a distal end of the second connector portion 322.

[0028] Figure 4 A perspective view of the handle assembly 300 is shown, wherein the first connector portion 321 is shown as transparent to reveal the internal components 350 of the handle assembly 300. The internal components 350 (e.g., air / water and / or suction tubes, electrical wires, working channel tubes, articulation lines configured to move the distal portion of the shaft 308, and other components) can extend through the first connector portion 321 and the second connector portion 322 to access the shaft 308.

[0029] Figure 5 A partial cross-sectional view of a portion of the handle assembly 300 is shown, which includes a handle body 320, a first connector portion 321, a second connector portion 322, and the shaft 308. Figure 5 As shown, the second connector portion 322 extends proximally into the first connector portion 321. The inner chamber 347 of the handle body 320 can be connected to the inner chamber 352 of the first connector portion 321, and the inner chamber 352 of the first connector portion 321 can be connected to the inner chamber 353 of the second connector portion 322, so that each inner chamber 47, 352, 353 is fluidly connected. For example, the opening of the first connector portion 321 that communicates with the inner chamber 347 is substantially coaxial with the axis 341, and the opening of the first connector portion 321 that communicates with the inner chamber 353 is substantially coaxial with the axis 342. The proximal wall of the first connector portion 321 extends from the distal side of the second connector portion 322 (relative to 320) to the second side 381. The distal wall of the first connector portion 321 extends from the proximal side of the second connector portion 322 (relative to 320) to the first side 380. The inner chamber 353 can be connected to the internal cavity 354 of the shaft 308. In some examples, the distal portion 366 of the second connector portion 322 can be received within the proximal portion 367 of the cavity 354. The component 350 of the handle assembly 300 can pass through the first connector portion 321 and the second connector portion 322 to access the shaft 308.

[0030] In operation, the user can rotate the first control knob 312 to move the distal tip of the shaft 308 (or the hinged portion of the shaft 308) to the right or left, can rotate the second control knob 314 to move the distal tip of the shaft 308 up or down, can actuate the locking lever 309 to brake or prevent movement of the distal tip in the left-right direction, and can actuate the locking knob 314 to brake or prevent movement of the distal tip in the up-down direction. The user can rotate the shaft 308 by pivoting the handle body 320 about the central longitudinal axis 342 of the shaft 308. For example, the user can pivot his wrist while grasping the handle body 320, the radioulnar joint axis 279 of the user's grasping hand can be substantially aligned with the central longitudinal axis 342 of the shaft 308, and the shaft 308 can be rotated about the axis 342. Because handle body 320 is offset from shaft 308, a user can move handle body 320 in a circumferential direction about axis 342 to rotate the shaft about axis 342, and first connection portion 321 can act as a lever and increase the amount of torque applied to shaft 308. Since the amount of torque required to rotate shaft 308 via handle body 320 is reduced compared to conventional handle assemblies (e.g., handle assembly 106), handle assembly 300 can reduce the amount of stress on the user's hand and wrist during operation because the amount of torque required to rotate shaft 308 is reduced.

[0031] The handle assembly 300 can reduce hand strain caused by excessive wrist movement when the user operates the endoscope 101, and can reduce the chance of the user losing grip. In addition, the handle assembly 300 can help prevent the user's hand from repeatedly repositioning on the medical device handle due to fatigue, strain or other difficulties. Each of the above-mentioned handle assemblies 106, 300, whether used in conjunction with an endoscope system or any other medical device, can be used to enhance and / or facilitate the user's grip on the handle and / or the user's ability to manipulate the medical device. Any portion of the handle assembly or actuator discussed herein can be incorporated into the handle of an endoscope or other medical device to improve the user's operation of the device.

[0032] It will be clear to those skilled in the art that various modifications and variations may be made to the disclosed apparatus and methods without departing from the scope of the present disclosure. Other aspects of the present disclosure will be clear to those skilled in the art from consideration of the specification and practice of the features disclosed herein. The specification and examples should be considered as exemplary only.

Claims

1. A handle assembly for a medical device, comprising: a handle body including a first central longitudinal axis, a first connector portion coupled to a distal end of the handle body, and A shaft extends distally from the first connector portion, wherein a second central longitudinal axis of the shaft is offset from the first central longitudinal axis of the handle body.

2. The handle assembly according to claim 1 further includes a second connector portion, which is coupled to (i) the proximal end of the shaft and (ii) the first connector portion, wherein the second connector portion is spaced apart from the first central longitudinal axis of the handle body.

3. The handle assembly of any one of the preceding claims, wherein the shaft further comprises: distal tip; as well as A camera is located at the distal tip.

4. The handle assembly of any one of the preceding claims, wherein the first internal chamber of the handle body is in communication with the second internal chamber of the first connector portion.

5. The handle assembly of claim 4, further comprising an inner assembly extending longitudinally through the first inner chamber and the second inner chamber.

6. The handle assembly of any one of the preceding claims, wherein the shaft includes a strain relief portion located at a proximal portion of the shaft.

7. The handle assembly of any one of the preceding claims, wherein the first connector portion includes a working channel port.

8. The handle assembly of any one of the preceding claims, wherein at least a portion of the first connector portion extends from a first side of the handle body to a second side of the handle body and projects radially outwardly from the second side of the handle body.

9. The handle assembly of any one of the preceding claims, wherein the first connector portion includes a proximally facing planar surface.

10. The handle assembly of any one of the preceding claims, wherein the handle body includes (a) a suction actuator and (b) an air and water actuator.

11. The handle assembly of any one of the preceding claims, wherein the handle body comprises a first control knob, a second control knob, a locking lever and a locking knob.

12. A handle assembly according to any one of the preceding claims, wherein the central longitudinal axis of the handle body is substantially parallel to the central longitudinal axis of the shaft.

13. The handle assembly of claim 2, wherein the second connector portion extends into (i) the first connector portion and (ii) the shaft.

14. A handle assembly according to any one of the preceding claims, wherein the connector is rectangular.

15. A handle assembly according to any one of the preceding claims, wherein the central longitudinal axis of the handle body is approximately 68 mm from the central longitudinal axis of the shaft.

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