Medical Devices and Related Systems and Methods

Abstract

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

Description

[Technical field]

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

[0002] During endoscopic procedures, medical personnel operating an endoscope often wrap their entire palm around the grip or handle portion of a medical device such as an endoscope. Due to various actuators on the handle of the endoscope, medical personnel are required to bend their hand frequently and for long periods of time during the procedure, which can cause strain and injury. In some cases, actuating various scope controls such as knobs and elevators can cause excessive movement of the medical personnel's thumb and other fingers, which can strain the medical personnel's hands. Endoscope operators may experience discomfort in their wrists and hands from gripping and operating the handle of the endoscope. For example, in some cases, medical personnel may experience symptoms similar to carpal tunnel syndrome or tendonitis. If a medical personnel experiences fatigue or other pain in the fingers, hand, or wrist, the medical personnel may change from a primary grip position to a secondary grip position that is a weaker grip than the primary grip position (e.g., changing from a four-finger grip to a three-finger grip). Repeated bending and movement of the wrist to adjust the position of the endoscope can increase fatigue and other pain.

[0003] If a healthcare professional repeatedly adjusts their grip during a procedure, it can prolong the procedure or make the procedure more difficult. Depending on the size of the healthcare professional's hands, the actuators may be placed in a suboptimal position, increasing the number of times the healthcare professional has to realign their hands during a procedure. Summary of the Invention

[0004] Aspects of the present disclosure relate, inter alia, to systems, devices, and methods that help reduce strain on a user's hands during manipulation of a handle assembly. The systems, devices, and methods of the present disclosure can facilitate a user's grip on an endoscope or other medical device. Endoscopes and other medical devices with handles that can rotate relative to a proximal shaft portion can help reduce fatigue and strain on a user's hands, reduce the need for realignment of the hand grip, and solve other problems. Each aspect disclosed herein can include one or more of the features described in connection with any of the other disclosed aspects.

[0005] According to one aspect, a handle assembly for a medical device is disclosed 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 extending distally from the first connector portion, the shaft having a second central longitudinal axis 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: A second connector portion may be coupled to (i) a proximal end of the shaft and (ii) the first connector portion, the second connector portion being spaced from the first central longitudinal axis of the handle body. The shaft may further include a distal tip and a camera disposed at the distal tip. A first internal cavity of the handle body may be in communication with a second internal cavity of the first connector portion. An internal component may extend longitudinally through the first internal cavity and the second internal cavity. The shaft may include a strain relief portion at a 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 project radially outward from the second side of the handle body. The first connector portion may include a proximally facing flat surface. The handle body may include (a) a suction actuator and (b) air and water actuators. The handle body may include a first control knob, a second control knob, a lock lever, and a lock 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 (i) into the first connector portion and (ii) into the shaft. The connector may be rectangular. The central longitudinal axis of the handle body may be approximately 68 mm from the central longitudinal axis of the shaft.

[0007] In another aspect, a handle assembly for a medical device includes a handle body including 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 and positioned completely distal to and spaced from the handle body; and a shaft extending distally from the second connector portion, the central longitudinal axis of the shaft being spaced 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 with the user's wrist on 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 another aspect, a method of operating an endoscope including a handle is disclosed that may include moving a handle body circumferentially about a central longitudinal axis of a shaft of an endoscope, with a user's wrist aligned on the central longitudinal axis of the shaft and the handle body 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 detailed description, serve to explain the principles of the disclosure. [Figure 1A] FIG. 1 is a perspective view of an exemplary endoscope according to aspects of the present disclosure. [Figure 1B] FIG. 1 is a perspective view of an exemplary endoscope according to aspects of the present disclosure. [Figure 2A] FIG. 1B is a perspective view of a user's hand gripping the handle of an endoscope (such as the handle of the endoscope of FIGS. 1A and 1B) according to an embodiment of the present disclosure. [Figure 2B] FIG. 1B is a perspective view of a user's hand gripping the handle of an endoscope (such as the handle of the endoscope of FIGS. 1A and 1B) according to an embodiment of the present disclosure. [Diagram 3] FIG. 1 is a side view of a portion of an endoscope including a handle assembly, according to an aspect of the present disclosure. [Figure 4]FIG. 1 is a side view of a portion of an endoscope including a handle assembly having certain transparent portions to reveal internal structure, in accordance with an aspect of the present disclosure. [Diagram 5] FIG. 5 is a side partial cross-sectional view of a portion of the handle assembly of FIGS. 3 and 4 according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] Detailed Description Reference will now be made in detail to the embodiments of the present disclosure, examples of which are illustrated in the accompanying drawings. Wherever possible, the same or similar reference numbers are used throughout the drawings to refer to the same or similar parts. The term "distal" refers to the portion of the device that is furthest from the user when introduced into a patient. Conversely, the term "proximal" refers to the portion of the device that is closest to the user when placed within a patient. Throughout the drawings contained herein, arrows labeled "P" and "D" are used to indicate proximal and distal directions in the figures. As used herein, the terms "comprises," "comprising," or other variations are intended to cover a non-exclusive inclusion, and a process, method, article, or device that includes a list of elements does not include only those elements, but may include other elements not expressly listed or inherent to such process, method, article, or device. The term "exemplary" is used in the sense of "example" and not "ideal." Furthermore, relative terms such as "about," "substantially," and "approximately" are used to indicate that values ​​or ranges may vary by ±10% from the stated numerical values ​​or ranges.

[0013] Embodiments of the present disclosure are directed to improving a user's ability to grasp, manipulate, and / or otherwise apply forces to the handles and handle actuators of a medical device (such as an endoscope) during a medical procedure. Among other non-limiting exemplary advantages, aspects of the present disclosure may reduce the need to reposition a user's hand during a procedure and may reduce strain on the user's hand from excessive finger movement.

[0014] 1A and 1B show perspective views of an exemplary endoscopic system 100. The endoscopic system 100 may include an endoscope 101. Although the term endoscope may be used herein, it will be understood that other devices may be used in connection with the devices of the present disclosure, including, but not limited to, a duodenoscope, colonoscope, ureteroscope, bronchoscope, laparoscope, sheath, catheter, or any other suitable delivery device or other type of medical device, and the handle assembly described below may be incorporated into any of these or other medical devices.

[0015] The endoscope 101 may include a handle assembly 106 and a flexible tubular shaft 108. The handle assembly 106 may include a biopsy port 102, a biopsy cap 103, an image capture button 104, an elevator actuator 107, a lock lever 109, a lock 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 of the actuators, elevators, knobs, buttons, levers, ports, or caps of the endoscope system 100 as listed above may be used for any purpose and are not limited by the specific use implied by the respective naming of each component as used herein. The umbilicus 105 may extend from the handle body 120 to auxiliary devices such as a control unit, a water / fluid source, and / or a vacuum source. The umbilicus 105 can transmit signals between the endoscope 101 and the control unit to control the illumination and imaging components of the endoscope 101 and / or receive image data from the endoscope 101. The umbilicus 105 can also supply fluid for irrigation from a water / fluid supply and / or a suction source to a distal tip 119 of the shaft 108. Buttons 116 and 118 control valves for suction and fluid supply (e.g., air and water), respectively. The shaft 108 can terminate at the distal tip 119. The shaft 108 can include articulations 122 for deflecting the distal tip 119 in an up, down, left, and / or right direction. Knobs 112 and 114 can be used to control such deflection. A locking lever 109 and a locking knob 110 can lock the knobs 112 and 114, respectively, in a desired position. The handle body 120 may be tapered, narrowing as the handle extends distally such that the profile of the handle body 120 is smaller at the distal end than at the proximal end.

[0016] The distal tip 119 may include an imaging device (e.g., a camera) and an illumination source (e.g., an LED or optical fiber). The distal tip 119 may be oriented sideways; that is, the imaging device and illumination source may face radially outward, perpendicular, approximately perpendicular, or transverse to the longitudinal axis of the shaft 108 and the distal tip 119. Alternatively, the distal tip 119 may be oriented forward; that is, the imaging device and illumination device may face approximately along the longitudinal axis of the distal tip 119 and the shaft 108.

[0017] When operating the endoscopic system 100, a user can hold the handle assembly 106 (shown in FIG. 2A ) with their left hand and hold an accessory device and / or operate one or more of the actuators of the handle assembly 106 (e.g., first and second control knobs 112, 114, lock lever 109, lock knob 110, etc.) with their right hand. A user can grip the handle assembly 106 by wrapping their hand around the handle body 120. When gripping the handle body 120, a user can use the thumb of their left hand to operate the first and second control knobs 112, 114 and elevator actuator 107 (by rotating them about their respective axes) and can use one finger of their left hand to operate the image capture button 104, the suction button 116, and / or the air / water button 118 (by pressing them).

[0018] 2A and 2B show an example of a user's left hand 201 gripping a handle assembly 106, which may have a central longitudinal axis 199 extending longitudinally through the handle assembly 106. The user may place the thumb 202 of the left hand 201 (the gripping hand) on the elevator actuator 107 and move the thumb 202 to move the elevator actuator 107 along a circular path from a first position (shown in FIG. 2A) to a second position (shown in FIG. 2B). FIG. 2A shows an axis 279 that coincides with the wrist radioulnar joint axis, i.e., the axis about which the hand 201 rotates when the user moves the wrist. For example, the user may rotate the handle assembly 106 by bending the wrist, thereby rotating the shaft 108. The handle assemblies described in this disclosure may facilitate gripping the handle, reduce strain on the user's hand when repositioning the medical device, and facilitate rotating the medical device using the user's hand and wrist.

[0019] FIG. 3 shows a perspective view of an alternative handle assembly 300 including a lock lever 309, a lock 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. A distal end 370 of the handle body 320 can be coupled to a first connector portion 321. The first connector portion 321 can include a working channel port 302 with a working channel opening 303. A proximal end 373 of the second connector portion 322 can be coupled to a distal portion 374 of the first connector portion 321, and the shaft 308 can include a strain 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 examples, the axis 341 can be substantially parallel to the axis 342. Axis 341 may be spaced from axis 342 by approximately 68 mm.

[0020] The offset of the handle body 320 from the shaft 308 (i.e., the offset of the axis 341 from the axis 342) makes it easier for a user to apply torque to the shaft 308 by moving the handle body 320. In some examples, when a user grips the handle body 320, the user's radioulnar joint axis 279 is generally aligned (i.e., substantially coaxial) with the central longitudinal axis 342 of the shaft 308, which makes it easier for the user to rotate the shaft 308 about the axis 342 when the user bends the wrist. As the shaft 308 rotates about the axis 342, the handle body 320 may move circumferentially about the axis 342. In other words, the first connector portion 321 and the handle body 320 may rotate about the axis 342.

[0021] At least a portion of the first connector portion 321 may extend across the distal end 370 of the handle body 320 from a first side 380 of the handle body 320 to a second side 381 of the handle body 320 and project radially outward from the second side 381 relative to the axis 341. For example, the distal end of the proximal end 383 of the first connector portion 321 may be substantially planar and abut the distal end 370 of the handle body 320. The proximal end 282 may include a proximally facing planar surface. In some examples, the first connector portion 321 may include a first half and a second half that are fastened together to form the first connector portion 321.

[0022] Working channel port 302 may be adjacent a first side 380 of handle body 320 and spaced from second connector portion 322. As will be further described in connection with FIG. 5 , a portion of second connector portion 322 may be housed within first connector portion 321. Shaft 308 may include a strain relief portion 376 coupled to a distal end of second connector portion 322.

[0023] 4 shows a perspective view of the handle assembly 300 with the first connector portion 321 shown in transparency to reveal the internal components 350 of the handle assembly 300. The internal components 350, such as air / water and / or suction tubes, electrical wiring, working channel tubes, control wires configured to move a distal portion of the shaft 308, and other components, can extend through the first connector portion 321 and the second connector portion 322 and into the shaft 308.

[0024] 5 shows a partial cross-sectional view of a portion of the handle assembly 300 including the handle body 320, the first connector portion 321, the second connector portion 322, and the shaft 308. As shown in FIG. 5, the second connector portion 322 extends proximally into the first connector portion 321. The interior cavity 347 of the handle body 320 communicates with the interior cavity 352 of the first connector portion 321, which communicates with the interior cavity 353 of the second connector portion 322, such that the interior cavities 47, 352, 353 are in communication. For example, the opening of the first connector portion 321 that communicates with the interior cavity 347 is substantially coaxial with the axis 341, and the opening of the first connector portion 321 that communicates with the interior cavity 353 is substantially coaxial with the axis 342. A proximal wall of the first connector portion 321 extends from the far side (relative to 320) of the second connector portion 322 to the second side 381. A distal wall of the first connector portion 321 extends from the near side (relative to 320) of the second connector portion 322 to the first side 380. The internal cavity 353 may be connected to an internal lumen 354 of the shaft 308. In some examples, a distal portion 366 of the second connector portion 322 may be housed within a proximal end 367 of the lumen 354. Components 350 of the handle assembly 300 may pass through the first connector portion 321 and the second connector portion 322 into the shaft 308.

[0025] In operation, a user can rotate the first control knob 312 to move the distal tip of the shaft 308 (or the joint of the shaft 308) right or left, rotate the second control knob 314 to move the distal tip of the shaft 308 up or down, actuate the lock lever 309 to brake or prevent left-right movement of the distal tip, and actuate the lock knob 314 to brake or prevent up-down movement of the distal tip. A user can rotate the shaft 308 by rotating the handle body 320 about the central longitudinal axis 342 of the shaft 308. For example, a user can rotate their wrist while gripping the handle body 320 so that the radioulnar joint axis 279 of the user's gripping hand is approximately aligned with the central longitudinal axis 342 of the shaft 308, causing the shaft 308 to rotate about axis 342. Because handle body 320 is offset from shaft 308, a user can rotate the shaft about axis 342 by moving handle body 320 circumferentially about axis 342, with first connector portion 321 acting as a lever to increase the amount of torque applied to shaft 308. Because the amount of torque required to rotate shaft 308 through handle body 320 is reduced compared to conventional handle assemblies (such as handle assembly 106), handle assembly 300 may reduce strain on a user's hand and wrist during operation due to the reduced amount of torque required to rotate shaft 308.

[0026] The handle assembly 300 can reduce hand strain caused by excessive wrist movement when the user operates the endoscope 101, reducing the chance of the user letting go. The handle assembly 300 also helps prevent the user's hand from repeatedly changing position on the handle of the medical device due to fatigue, strain, or other difficulties. Each of the handle assemblies 106, 300 described above, whether or not used in conjunction with an endoscope system or other medical device, can be used to improve and / or facilitate a user's grip on the handle and / or the user's ability to operate the medical device. Any portion of the handle assembly or actuator described herein can be incorporated into the handle of an endoscope or other medical device to improve a user's operation of the device.

[0027] It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed devices and methods without departing from the scope of the present disclosure. Other aspects of the present disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the features disclosed herein. It is intended that the specification and embodiments be considered as illustrative only.

Claims

1. A handle assembly for a medical device, Handle body including the first central longitudinal axis, A first connector portion connected to the distal end of the handle body, and A shaft extending distally from the first connector portion. A handle assembly comprising a shaft, wherein the 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 comprising (i) the proximal end of the shaft, and (ii) a second connector portion coupled to the first connector portion, wherein the second connector portion is spaced apart from the first central longitudinal axis of the handle body.

3. The aforementioned shaft further, Distal tip, and The camera located at the distal end A handle assembly according to claim 1 or 2, comprising:

4. The handle assembly according to claim 1 or 2, wherein the first internal cavity of the handle body communicates with the second internal cavity of the first connector portion.

5. The handle assembly according to claim 4, further comprising an internal component extending longitudinally through the first internal cavity and the second internal cavity.

6. The handle assembly according to claim 1 or 2, wherein the shaft includes a strain relief portion in the proximal portion of the shaft.

7. The handle assembly according to claim 1 or 2, wherein the first connector portion includes a work channel port.

8. The handle assembly according to claim 1 or 2, wherein at least a portion of the first connector portion extends from the first side of the handle body to the second side of the handle body and protrudes radially outward from the second side of the handle body.

9. The handle assembly according to claim 1 or 2, wherein the first connector portion includes a plane facing proximal.

10. The handle assembly according to claim 1 or 2, wherein the handle body includes (a) a suction actuator and (b) air and water actuators.

11. The handle assembly according to claim 1 or 2, wherein the handle body includes a first control knob, a second control knob, a locking lever, and a locking knob.

12. The handle assembly according to claim 1 or 2, wherein the central longitudinal axis of the handle body is substantially parallel to the central longitudinal axis of the shaft.

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

14. The handle assembly according to claim 1 or 2, wherein the connector is rectangular.

15. The handle assembly according to claim 1 or 2, wherein the central longitudinal axis of the handle body is located approximately 68 mm from the central longitudinal axis of the shaft.

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