Rotatable medical device

Abstract

To provide an improved medical device that includes a shaft that is rotatable relative to a handle.SOLUTION: A medical device comprises a shaft, a handle including a proximal portion and a distal portion, the distal portion being fixed to a proximal portion of the shaft, and a channel extending from the handle into the shaft and including a proximal channel and a distal channel, the proximal channel being rotatable relative to the distal channel and aligned with the distal channel throughout rotation of the proximal channel. The proximal portion of the handle includes the proximal channel and the distal portion of the handle includes the distal channel. The distal portion of the handle is rotatable relative to the proximal portion of the handle, and the shaft is configured to rotate with the distal portion of the handle.SELECTED DRAWING: Figure 1A

Description

Technical Field

[0001] The present invention relates to a medical device including a shaft rotatable with respect to a handle. More particularly, the present invention relates to a medical device in which a distal portion of a handle is rotatable with respect to other portions, and further, in a state where the distal portion houses a shaft, the distal portion is connected to the shaft.

Background Art

[0002] In certain medical procedures, physicians and technicians need to control a bronchoscope (or other scope or medical device) and other medical accessory devices. Depending on the position of the patient relative to the position of the physician, the physician controlling the device may need to contort or twist their body into unnatural positions in order to guide the medical device to the desired site of the biological structure. As a result, the physician may be placed in an ergonomically undesirable position or the surgery may be affected.

Summary of the Invention

[0003] According to one example, a medical device includes a shaft, a handle including a proximal portion and a distal portion, the distal portion being fixed to the proximal portion of the shaft, and a channel extending from the handle into the shaft, the channel including a proximal channel and a distal channel, the proximal channel being rotatable with respect to the distal channel and being aligned with the distal channel throughout rotation of the proximal channel, the proximal portion of the handle including the proximal channel, the distal portion of the handle including the distal channel, the distal portion of the handle being rotatable with respect to the proximal portion of the handle, and the shaft being configured to rotate with the distal portion of the handle.

[0004] In another example, the shaft surrounds at least a portion of the distal channel, and the distal channel may be configured to rotate together with the shaft and the distal portion of the handle. The distal portion of the handle may be rotatable relative to the proximal portion of the handle in a clockwise or counterclockwise direction. The rotation of the distal portion of the handle may be limited to a set angle of rotation. The distal portion of the handle may be maintained in a stationary state relative to the proximal portion of the handle by the frictional force generated by the contact between the surface of the distal portion and the surface of the proximal portion. The handle further includes a guide, the guide includes a lumen extending along the central axis of the guide, and the lumen is disposed between the proximal channel and the distal channel and may be aligned with the proximal channel and the distal channel. The guide may be fixed to the inner surface of the proximal portion of the handle. The distal portion of the handle further includes a support along the inner surface of the distal portion of the handle, and the proximal portion of the shaft may be fixed to the support.

[0005] In another example, the medical device further includes a lock having a first form and a second form. In the first form of the lock, the distal portion of the handle is stationary relative to the proximal portion of the handle. In the second form of the lock, the distal portion of the handle may be rotatable relative to the proximal portion of the handle. The lock includes a first washer including a pin protruding in the proximal direction, the distal channel extending through the opening of the first washer through the first washer, a second washer including a plurality of openings each configured to receive the pin, and a spring connecting based on the distal surface of the first washer. In the first form of the lock, the first washer may be spring-biased toward the second washer such that the pin of the first washer engages with one of the plurality of openings of the second washer. In the second form of the lock, the first washer is spaced proximally from the second washer, compressing the spring, whereby the pin may be disengaged from all of the plurality of openings. The lock further includes a tube, the tube extends through the openings of the first washer and the second washer, the tube covers at least a portion over the distal channel, and the first washer may be configured to move over the tube.

[0006] In another example, the medical device further includes a first steering wire and a first gyroscope that holds the first steering wire. The first gyroscope includes a proximal gyroscope and a distal gyroscope. The distal gyroscope may be fitted to the proximal gyroscope such that the distal gyroscope is rotatable relative to the proximal gyroscope around the outer periphery of the distal channel or the proximal channel. The first steering wire includes a proximal wire and a distal wire. The distal end of the proximal wire is connected to a first extension portion, and the proximal end of the distal wire is connected to a second extension portion. The first extension portion may be fixed to the proximal gyroscope, and the second extension portion may be fixed to the distal gyroscope. When the proximal wire is pulled via a drive device, the distal wire may be configured to be pulled.

[0007] According to one example, the medical device includes a shaft, a handle connected to the proximal portion of the shaft, and a channel extending from the handle to the shaft. The channel is rotatable relative to the handle, and the sidewall of the channel includes an opening in a portion of the channel that is received in the handle. The handle defines a lumen that communicates with the opening of the channel, and the proximal end of the lumen may be configured to communicate with a suction source. The opening may be sealed from a portion of the handle by a first seal and a second seal. The sidewall of the channel may include a plurality of circumferentially distributed openings.

[0008] According to one example, a method of positioning a shaft of a medical device that further includes a handle including a proximal portion and a distal portion rotatably attached to the proximal portion, and a channel extending from the second portion to the shaft, with the proximal portion of the shaft fixed to the distal portion of the handle, may include introducing a distal end of the shaft of the medical device into a subject's body, and after the introducing step, rotating the distal portion of the handle, the shaft, and the channel relative to the proximal portion of the handle.

[0009] In another example, after the introducing step, the method may further include unlocking the distal portion of the handle from the proximal portion of the handle, rotating the distal portion of the handle, the shaft, and the channel with respect to the proximal portion of the handle, and locking the distal portion of the handle to the proximal portion of the handle.

[0010] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various exemplary embodiments and, together with the description, serve to explain the principles of the disclosed embodiments.

Brief Description of the Drawings

[0011]

Figure 1A

Figure 1B

Figure 2A

Figure 2B

Figure 2C

Figure 3A

Figure 3B

Figure 4

Modes for Carrying Out the Invention

[0012] Here, the aspects of the present invention illustrated in the accompanying drawings will be described in detail. As much as possible, the same or similar reference numerals are used throughout all the drawings to refer to the same or similar parts. The term "distal" means the part that is farthest from the user when introducing the device into a subject (e.g., a patient). On the other hand, the term "proximal" means the part that is closest to the user when placing the device on the subject.

[0013] The above general description and the following detailed description are merely exemplary and explanatory and do not limit the claimed features. As used herein, the terms "comprise," "comprising," "include," "including," or other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises 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 apparatus. In the present invention, for example, relative terms such as "about," "substantially," "generally," and "broadly" are used to indicate a possible variation of ±10% in the stated value or characteristic.

[0014] According to embodiments of the present invention, it is possible to solve one or more problems in the relevant technical field. However, the scope of the present invention is defined by the appended claims and not by the ability to solve a particular problem. The present invention has been made with respect to a medical device including a shaft that can be rotatable relative to a handle of the medical device. The medical device may be, for example, any scope having a shaft extending distally from a handle (such as a bronchoscope, duodenoscope, endoscope, colonoscope, ureteroscope, etc.), a catheter, a tool, an instrument, or the like. In an embodiment, the medical device includes a handle having a distal portion that can be rotated clockwise or counterclockwise relative to a proximal portion of the handle. The medical device further includes a shaft that is connected to be fixed to the distal portion of the handle and is housed within the distal portion of the handle. Thus, when the distal portion of the handle is rotated relative to the proximal portion of the handle, the shaft rotates similarly at the same time. The distal portion of the handle may be in either of two states or configurations. In the first state, the distal portion may be held stationary relative to the proximal portion of the handle. In the second state, the distal portion of the handle can rotate or be rotatable relative to the proximal portion of the handle. Alternatively, the proximal portion of the handle can rotate or be rotatable relative to the distal portion. The shaft of the medical device rotates according to the distal portion of the handle or is maintained in a stationary state.

[0015] Embodiments of the medical device of the present invention can use any suitable means, such as friction, a lock / unlock mechanism, etc., to place or maintain the distal portion of the handle in either of the two states described above. Further, such a medical device can provide the user with the option to rotate the distal portion of the handle (and thus the shaft) during surgery, for example, via any suitable method such as manual, mechanical, electrical, etc., and the option to fix and maintain the distal portion of the handle at its current rotational position relative to other parts of the device. Thereby, the device user can comfortably access, visually identify, or perform a treatment / diagnostic procedure at the target site via rotation of the distal portion of the handle and the shaft without the need to twist or distort the wrist or other part of the body, regardless of the position of the patient relative to the user.

[0016] In FIG. 1A, a medical device 1 according to an embodiment, for example, a bronchoscope, is shown. The medical device 1 includes a flexible shaft 24 (for example, a catheter) and a handle 5 connected to the proximal end of the flexible shaft 24. The handle 5 has a drive device 43. The drive device 43 controls the articulation movement of at least one of the flexible shaft 24 and the articulation joint provided at the distal end of the flexible shaft 24 in a plurality of directions. The device 43 may be, for example, a rotation knob that rotates about the axis of the device to push or pull a drive element, for example, a steering wire (not shown). A drive element such as a cable or wire suitable for a medical procedure (for example, a medical grade plastic or metal) extends distally from the proximal end of the medical device 1 and connects to the distal portion of the flexible shaft 24 to control its operation. Alternatively or additionally, the user may operate a drive element independent of the handle 5. The distal end of the drive element extends through the flexible shaft 24 and may terminate at the articulation joint or the distal tip of the flexible shaft 24. For example, one or more drive elements may be connected to the articulation joint, and by driving the drive elements, the articulation joint or the distal end of the flexible shaft 24 may be controlled to move in a plurality of directions (for example, at least one of up / down and left / right).

[0017] Furthermore, one or more electrical cables (not shown) may extend from the proximal end of the medical device 1 to the distal end of the flexible shaft 24, and at the distal end of the flexible shaft 24, an imaging device, a lighting device, or other electrical devices can be electrically controlled, processed, or displayed on a display by transmitting an imaging signal in the proximal direction from the distal end of the flexible shaft 24. The handle 5 may include ports 11, 46 for introducing instruments, body fluids, or other substances or removing instruments, body fluids, or other substances from the patient's body. The port 11 may be used for introducing an instrument through the working channel 12. The port 46 may be connected to an umbilicus for at least any one of introducing, aspirating body fluids, and wiring electronic components. Furthermore, the medical device 1 may further include a stress relief portion 23 attached to the distal end of the handle 5. The stress relief portion 23 may be tapered towards the distal direction and may be a cover of any suitable soft material having an opening for the shaft 24 at its distal end. The stress relief portion 23 is not particularly limited and helps to prevent the shaft 24 from twisting.

[0018] Referring to FIGS. 1A and 1B, the handle 5 will be described in more detail below. The handle 5 includes a proximal portion 10 and a rotatable distal portion 20. The distal portion 20 is a different element from the proximal portion 10. Thus, in some embodiments, the handle 5 is not a single part but two different parts consisting of the proximal portion 10 and the distal portion 20. The distal portion 20 is rotatably attached to the proximal portion 10, and the two are adjacent to each other.

[0019] The proximal portion 10 may have a suitable shape configured for handling or gripping by the user and may be formed of a suitable material, such as plastic, steel, etc. The proximal portion 10 includes the drive device 43 and ports 46, 11 described above. As described above, the proximal portion 10 may be part of the handle 5 configured to be connected to further wiring and instruments via the ports 46, 11. The port 11 may lead to a proximal working channel 12 for introducing various instruments therein.

[0020] The proximal working channel 12 may be in any suitable form and is not particularly limited. For example, in some embodiments, the proximal working channel 12 may be a tube connected to the port 11, which may be flexible or formed to conform to the shape of the proximal portion 10. In other embodiments, a hollow tubular channel may be formed within the proximal portion 10 to form the proximal working channel 12, and the channel 12 may be formed of any suitable material, such as plastic, steel, etc. The channel 12 has any suitable diameter or length. The distal portion of the channel 12 transitions to the lumen 14' of the guide 14. The guide 14 may be formed as an integral unit with the channel 12. The guide 14 is tubular or cylindrical in shape and includes the lumen 14'. The lumen 14' extends along the central axis of the guide 14. The lumen 14' has the same or substantially the same diameter as the channel 12. The guide 14 may be a molded article fixed within the proximal portion 10 via a support 15 extending from the inner surface of the proximal portion 10 to the guide 14. Also, the support 15 may be a molded article inserted within the proximal portion 10. Also, the support 15 may include any suitable wires and suitable openings or channels for allowing a suction or cleaning tube, etc. to pass through the support 15 towards the distal end of the shaft 24. Further, the device 1 may also define a space within the proximal portion 10 and the distal portion 20 to enable the same.

[0021] The guide 14 and the lumen 14' function as a transition between the distal end of the channel 12 in the proximal portion 10 and the proximal end of the distal working channel 22 in the distal portion 20. The distal end of the guide 14 includes a circular gap or recess 16 for receiving the sealing ring 13. The ring 13 (e.g., an O-ring) is attached to the outer periphery of the distal working channel 22. Thus, the diameter of the space within the ring 13 can be the same as, or approximately the same as, the outer diameter of the working channel 22. However, the ring 13 is attached to the outer periphery of the channel 22 such that the channel 22 can rotate within the ring 13. Alternatively, the ring 13 and the channel 22 may rotate together within the recess 16. The ring 13 is formed of any suitable material that can seal the outer periphery of the distal channel 22 and may provide centering of the proximal end of the channel 22 within the recess 16 of the guide 14. Thus, from the above perspective, the proximal channel 12, the lumen 14', and the distal channel 22 are maintained in a completely aligned state without displacement.

[0022] The distal portion 20 includes the proximal portion of the distal working channel 22. The distal working channel 22 may be of any suitable configuration, similar to the proximal channel 12. For example, the channel 22 may be a tube extending from the end of the lumen 14' of the guide 14 to the distal end of the shaft 24, as described above. Regardless of the shape, the diameter of the channel 22 is the same as, or approximately the same as, the channel 12. In other embodiments, the diameter of the channel 22 may be smaller or larger than the diameter of the channel 12. Further, as described above, the proximal channel 12 communicates with the lumen 14', and the lumen 14' communicates with the distal channel 22.

[0023] The distal portion 20 further includes the proximal portion of the shaft 24 and the clamp 26. The shaft 24 can be of any suitable length that includes at least a part or all of the distal working channel 22 and has any suitable length extending from the distal portion 20 to the distal end of the medical device 1, and can be a tube. The shaft 24 can be a tube made of any suitable material having flexibility. The diameter of the shaft 24 is not particularly limited as long as it can accommodate the distal working channel 22 and any desired wires, aspiration / irrigation tubes, etc. The clamp 26 is a circular clamp / aperture formed as part of the distal portion 20. The clamp 26 is configured to hold / clamp the proximal portion of the shaft 24, and the shaft 24 is fixed to the distal portion 20. Considering such a configuration, the aperture of the clamp 26 has a diameter that is the same as or substantially the same as the outer diameter of the shaft 24. Further means for fixing the clamp 26 to the shaft 24, including adhesives, welding, etc., may be used. Thus, since the proximal portion of the shaft 24 is clamp-fixed to the distal portion 20 of the handle, when the distal portion 20 of the handle rotates clockwise or counterclockwise with respect to the proximal portion 10 of the handle, the shaft 24 (and the working channel 22) rotates. At least a part of the distal working channel 22 may be fixed to the shaft 24 (via adhesives, welding, etc.) so as to rotate simultaneously.

[0024] As described above, the distal portion 20 is rotatably attached to the proximal portion 10. The proximal portion 10 and the distal portion 20 are in contact with each other and flush with each other. The abutting ends of the proximal portion 10 and the distal portion 20 are circular and have the same diameter. The means by which the distal portion 20 is rotatably attached to the proximal portion 10 is not particularly limited, and both the proximal portion 10 and the distal portion 20 may include any suitable connecting element (not shown). For example, the proximal surface of the distal portion 20 may engage the distal surface of the proximal portion 10 via an anchor / slot connection mechanism that prevents separation of the proximal portion 10 and the distal portion 20. In such an example, the distal surface of the proximal portion 10 may have a recess extending circumferentially across the entire distal surface, and the proximal surface of the distal portion 10 may have an element / feature protruding in the proximal direction configured to fit securely within this recess. In another example, the distal surface of the proximal portion 10 may have a shape protruding in the distal direction, and the proximal surface of the distal portion 20 may include a recess. However, the attachment of the distal portion 20 to the proximal portion 10 is not limited as described above, and other suitable means may be used.

[0025] The distal portion 20 may be attached to the proximal portion 10 such that the distal portion 20 is restricted to a rotation angle, for example, approximately 90°, 120°, 180°, etc., with respect to the proximal portion 10. Thus, in such an example, the connecting elements of the distal portion 20 and the proximal portion 10 may include additional means for restricting the rotation of the distal portion 20. For example, a stopper may be disposed at a predetermined or selected position within the recess such that contact between the protruding feature and the stopper prevents rotation of the distal portion 20 beyond the stopper. However, the connecting means is not limited to the description herein, and other suitable elements / features may be used to limit the rotation angle of the distal portion 20.

[0026] The distal portion 20 and the working channel 22 rotate about the central axis A of the distal working channel 22. Thus, the channel 22 maintains complete alignment with the lumen 14 and the proximal channel 12 throughout the rotation of the distal portion 20. Accordingly, when the distal channel 22 rotates (due to the rotation of the distal portion 20) relative to the proximal channel 12, an accessory or instrument extending through the interiors of both channels 12, 22 can be protected from any damage, such as pinch-off.

[0027] As described above, the distal portion 20 can be maintained in a stationary state, i.e., a stationary configuration, relative to the proximal portion 10. To maintain the stationary state, the distal portion 20, or at least the surface of the distal portion 20 that abuts the proximal portion 10, is constructed of any suitable friction material, whereby unwanted movement of the distal portion 20 can be prevented while it is in contact with the proximal portion 10. To increase the friction between both the proximal portion 10 and the distal portion 20, the proximal portion 10, or at least the surface of the proximal portion 10 that abuts the distal portion 20, may also be formed of any suitable friction material. The frictional force generated between the distal portion 20 and the proximal portion 10 can be sufficient to prevent unwanted rotation of the distal portion 20 relative to the proximal portion 10. However, the frictional force may not exceed the normal torsional force applied by the user of the medical device 1, and the distal portion 20 can be rotated by the user as needed.

[0028] Referring to FIGS. 1A-1B, an example of the usage of the medical device 1 will be further described below. The distal end of the shaft 24 of the medical device 1 is delivered into the patient's body adjacent to the target site. The delivery can be performed through natural body openings such as the mouth, nose, anus, etc. Imaging corresponding to the medical device 1 via any suitable imaging device can assist in positioning the distal end of the shaft 24. Depending on the position of at least one of the patient and the target site with respect to at least one of the medical device 1 and the user of the medical device 1, the user may choose to rotate the shaft 24 with respect to the handle 5. To rotate the shaft 24, the user can rotate the distal portion 20 of the handle 5 with respect to the proximal portion 10 by applying a torsional force that exceeds the frictional force between the proximal portion 10 and the distal portion 20. The user can rotate the distal portion 20 (and the shaft 24) to enable handling of the handle 5 by the user in a more ergonomic posture or for various other reasons. Thus, the user can relatively rotate the shaft 24 (via rotation of the distal portion 20) or the proximal portion 10 of the handle 5 to any desired degree.

[0029] As shown in FIG. 2A, medical device 1' is similar to device 1 in many respects. Similar reference numerals indicate similar components. The differences between device 1 and device 1' are described below. Device 1' further includes a lock 30. The lock 30 can include a form (e.g., a locked form) in which the distal portion 20 and the shaft 24 can freely rotate in any direction (clockwise or counterclockwise) with respect to the proximal portion 10, and another form (e.g., an unlocked form) in which the distal portion 20 and the shaft 24 are maintained in a stationary state and are not rotatable with respect to the proximal portion 10. Referring to FIGS. 2A-2C, the lock 30 includes a slidable lock washer 31 having a lock pin 32, a receiving washer 33 configured to engage the lock washer 31 and the pin 32, a base washer 34, and a spring 35 that connects the lock washer 31 to the base washer 34. The lock 30 is disposed to be located distally of the guide 14, and the channel 22 extends through a central opening along the axes of the washers 31, 33, and 34. The lock 30 further includes a central tube 40 that similarly extends through a central opening along the axis of the washers 31, 33. The tube 40 is hollow and covers a portion of the channel 22 that extends from the guide 14 to the washer 34. Thus, a portion of the tube 40 fits within the recess 16 of the guide 14. As will be described in more detail below, the tube 40 can be fixed to the washer 31 such that the tube 40 rotates or slides with the washer 31. However, the tube 40 need not be fixed to the washer 33 such that the tube 40 can rotate and slide with respect to the washer 33. The distal end of the tube 40 is fixed to the washer 34.

[0030] The lock washer 31 is circular / disc-shaped in form, but is not limited thereto. The dimensions of the washer 31 are not particularly limited as long as it is fixed within the distal portion 20. The lock washer 31 is attached to the outer periphery of the tube 40 via a central opening such that the washer 31 can slide on the tube 40. The lock washer 31 includes a lock pin 32, which can be a pin protruding in the proximal direction. The pin 32 is disposed at a position on the proximal surface of the washer 31 where the pin 32 engages with one of the receiving holes 36 of the receiving washer 33 (to be described in more detail below). The length and diameter of the pin 31 are not particularly limited as long as the pin 32 engages with the receiving hole 36. Similarly, the washer 33 is circular / disc-shaped in form, but is not limited thereto. In the device 1', the washer 33 has a smaller diameter than the washer 31. However, the dimensions of the washer 33, such as the diameter, are not particularly limited. Since the washer 33 is attached to the outer periphery of the tube 40 via the central opening of the washer 33, the tube 40 can slide or rotate about the central axis with respect to the washer 33 and the proximal portion 10. The washer 33 located proximal to and adjacent to the washer 31 includes a plurality of receiving holes 36 on its distal surface. The holes 36 may extend completely through the thickness of the washer 33 or may extend partially through the washer 33 (e.g., as recesses). The holes 36 may have a shape and width / diameter that accommodate the pin 32 of the washer 31. The receiving holes 36 may be circumferentially evenly arranged about the center point of the washer 33. The number of receiving holes 36 is not particularly limited. The base washer 33 is circular / disc-shaped in form, but is not limited thereto. The dimensions of the washer 33 are also not particularly limited as long as it is fixed within the distal portion 20. In the device 1', a part of the proximal surface of the washer 33 is fixed to the distal end of the guide 14 within the distal portion 20. Accordingly, the washer 33 does not rotate with the distal handle portion 20. However, the washer 33 is not limited to being fixed to the distal end of the guide 14. The washer 33 may also be fixed to other parts or elements within the proximal portion 10 such that the washer 33 does not rotate with the distal portion 20.The washer 34 is on the distal side of the lock washer 31 and is thus located at the most distal end of the lock 30. The spring 35 is disposed between the washer 34 and the lock washer 31 such that the spring 35 connects the proximal face of the washer 34 to the distal face of the lock washer 31. The distal face of the washer 34 is fixed to the proximal face of the clamp 26. Thus, the washer 34 can function as a fixed base portion for the lock washer 31 to slide on the tube 40 due to the expansion and contraction of the spring 35. The washers 34, 31 and the spring 35 rotate together with the distal handle portion 20.

[0031] As described above, the distal face of the washer 31 is connected to the base washer 34 via the spring 35. As a result, the washer 31 of the distal portion 20 is spring-biased to engage with the washer 33 via one of the pin 32 and the hole 36. As described above, the washer 33 is fixed to the guide 14, and the guide 14 is fixed to the proximal portion 10 via the support 15. Thus, the lock 30 is default-set in the locked configuration, thereby preventing relative rotation of the distal portion 20 (and the shaft 24) or the proximal portion 10.

[0032] To shift the lock 30 from the default locked configuration to the unlocked configuration (shown in FIG. 2A), a pulling force may be applied to the distal portion 20 in the distal direction (as indicated by the directional arrow). The connection between the distal portion 20 and the proximal portion 10 allows relative movement between the distal portion 20 and the proximal portion 10 along the axis A. This is shown by the gap between the distal portion 20 and the proximal portion 10 when the lock 30 is in the unlocked configuration. For example, the protruding and recessed portions or both contact surfaces (not shown) of the proximal portion 10 and the distal portion 20 described above may be configured to allow relative movement. The pulling force disengages the lock washer 31 from the receiving washer 33 of the proximal portion 10. The pin 32 of the washer 31 is retracted outside one of the openings 36 of the washer 31. The pulling force may be applied via any suitable method, such as manually, mechanically, electrically, etc. Upon disengagement, the distal portion 20 (and the shaft 24 fixed to the portion 20) or the proximal portion 10 may freely rotate relative to each other in the clockwise or counterclockwise direction. By releasing the applied force, the lock washer 31 may be returned to its original position, i.e., the position where the lock washer 31 abuts and engages the washer 33. If the misalignment between the pin 32 and one of the holes 36 of the washer 33 prevents the washer 31 from engaging the washer 33, further rotation may be performed until alignment and engagement occur.

[0033] The medical device 1' may be used in the same manner as the medical device 1, except that the user can pull the distal portion 20 in the distal direction to release the lock 30, rotate the distal portion 20 (and the shaft 24) or the proximal portion 10 relative to each other to a desired extent, release the distal portion 20, and return the lock 30 to the locked configuration.

[0034] FIG. 3A shows a rotatable gyro 50 that can be included in an embodiment of a medical device, including the above-described devices 1, 1'. As shown in the figure, the rotatable gyro 50 surrounds a part of the guide 14 and the working channel 22 and holds the steering wire 60. The gyro 50 may be attached around the region where the lumen 14' and the working channel 22 are in contact. However, the gyro 50 is not limited to such a position and may be attached, for example, around the outer periphery of the portion of the guide 14 within the proximal portion 10. Further, the presence of the gyro 50 and the lock 30 in the medical device handle is not mutually exclusive. In some examples, the handle may include a gyro 50 attached around the guide 14 and the channel 22 and a lock 30 similarly attached around the channel 22.

[0035] The steering wires of conventional medical devices (such as scopes) are all single components wired from the handle to the distal end of the shaft. However, when such a steering wire is rotated while the shaft is rotated, the steering wire may be damaged due to torsional strain caused by the rotation. To address such concerns, the steering wire 60 consists of two separate and distinct wires, a proximal wire 61 and a distal wire 63, to enable rotation of the distal portion 20 (and shaft 24) without damaging the steering wire 60 as described above. The proximal end of the proximal wire 61 can be connected to any suitable controller, such as the device 43 shown in FIG. 1. The distal end of the proximal wire 61 is connected to or integrated with the first terminal / ferrule ball 62. The distal end of the distal wire 63 is connected to the distal end of the shaft 24 to control the articulation of the shaft 24. The proximal end of the distal wire 63 is connected to or integrated with the second terminal / ferrule ball 64. The balls 62, 64 may be of any suitable material, such as lead, and are not particularly limited. Alternatively, each ball 62, 64 may be a machined or heat-treated end of the corresponding wire 61, 63. Further, the balls 62, 64 are not particularly limited to being balls and may be any suitable expansion portion. Similarly, the wires 61 and 63 are not particularly limited and may be any suitable cable or wire (such as medical-grade plastic or metal) used in medical procedures.

[0036] The gyro 50 includes a proximal gyro 51 and a distal gyro 55 that are relatively rotatably connected. The proximal gyro 51 forms a structure that surrounds the guide 14 and holds the proximal wire 61. The distal gyro 55 forms a structure that surrounds the distal working channel 22 and holds the distal wire 63. The distal gyro 55 can be fixed around the channel 22 so as to be rotatable with the channel 22 relative to the proximal gyro 51. The proximal gyro 51 can be fixed to the guide 14. The proximal gyro 51 includes a recess 52 and a flange 53 that protrudes in the proximal direction and partially covers the recess 52. The proximal gyro 51 further includes a flange 73 that is located proximal to the recess 52 and protrudes radially outward with respect to other parts of the proximal gyro 51. The distance by which the flange 73 protrudes is not particularly limited as long as it is accommodated within the device 1''. The flange 73 includes a channel 74 at approximately the midpoint of its radial protrusion. The channel 74 extends parallel or substantially parallel to the longitudinal axis of the guide 14. The width of the channel 74 can be such that it fits the proximal wire 61, but is narrower than the diameter of the first ball 62 located distal to the channel 74. Thus, the channel 74 holds the proximal wire 61 and at the same time fixes the first ball 62 so as to prevent the proximal wire 61 from slipping out of the channel 74 when the proximal wire 61 is pulled proximally. The distal gyro 55 includes a gap 56 and a flange 57 that protrudes in the distal direction and partially covers the gap 56. The distal gyro 55 also includes a flange 71 that is similar to the flange 73 in many respects. The flange 71 includes a channel 72 at approximately the midpoint of its radial protrusion. Similar to the flange 73, the flange 71 holds the distal wire 63 and at the same time fixes the second ball 64 so as to prevent the distal wire 63 from slipping out of the channel 72 when the distal gyro 55 is pulled proximally. Since the gap 56, the flange 57, the recess 52, and the flange 53 are annular, they engage in the circumferential direction of the proximal gyro 51 and the distal gyro 55.

[0037] The proximal gyro 51 and the distal gyro 55 can always engage with each other by their fitting. The distal gyro 55 is fitted around the outer periphery of the flange 53 of the proximal gyro 51 such that the part of the distal gyro 55 and the part of the proximal gyro 51 come into firm contact with each other and at the same time enable the distal gyro 55 or the proximal gyro 51 to rotate relative to each other. The flange 57 of the distal gyro 55 and the flange 53 of the proximal gyro 51 are hooked with respect to each other such that the flange 57 stays within the recess 52 of the proximal flange 51 and the flange 53 stays within the gap 56 of the distal gyro 55. Accordingly, the hook-shaped elements of the flanges 53, 57 prevent the proximal gyro 51 and the distal gyro 55 from separating from each other. The dimensions of the flanges 53, 57, the recess 52 and the gap 56 are not particularly limited and can be any appropriate dimensions that enable the above-described rotatable fitting engagement between the proximal gyro 51 and the distal gyro 55.

[0038] From the above viewpoints, the rotatable gyro 50 enables the rotation of the proximal steering wire 61 or the distal steering wire 63 when the distal part 20 or the proximal part 10 rotates relative to each other. Further, the above configuration of the gyro 50 enables the articulation of the flexible shaft 24 via the steering wire 60. The proximal wire 61 including the first ball 62 can be pulled via the drive of any suitable controller, for example, the device 43 (not shown), and as a result, the proximal gyro 51 may be pulled by pulling the first ball 62 with respect to the flange 73. By pulling the proximal gyro 51, the distal gyro 53 is pulled by their fitting engagement. This then pulls the distal steering wire 63 by pressing the flange 71 against the second ball 64, and as a result, the steering wire 63 pulls the distal end of the shaft 24, thereby enabling its articulation.

[0039] FIG. 3B shows a medical device 1’’ including two rotatable gyros 50a, 50b, both of which are identical to the rotatable gyro 50 of FIG. 3A. The gyros 50a, 50b each hold two steering wires 60a, 60b. The number of gyros included in the medical device is not particularly limited and can be any suitable number corresponding to the number of steering wires (e.g., one, two, or four) within the medical device embodiment. As shown in FIG. 3B, the rotatable gyro 50a, which is one of the gyros, can be disposed around the region where the lumen (not shown) of the guide 14 and the working channel 22 are in contact, as described above for FIG. 3A. On the other hand, the rotatable gyro 50b, which is the second gyro, can be disposed more proximally than the gyro 50a so as to be located within the proximal portion 10 as well. The steering wires 60a, 60b are connected to the distal end of the shaft 24. Thus, when the shaft 24 rotates, the distal gyros 55a, 55b holding the distal wires 63a, 63b can also rotate.

[0040] In a medical device including a rotatable working channel, aspiration may also be possible. As shown in FIG. 4, the medical device 1''' is similar to the device 1 in some respects. Similar reference numerals indicate similar parts. The differences between the device 1 and the device 1''' are described below. In the device 1''', the working channel 12' is a rotatable tube that extends from the proximal portion 10 through the rotatable distal portion 20'' to the distal end of the shaft (not shown). At least a part of the channel 12' can be fixed to the shaft. Thus, when the distal portion 20'' and the shaft rotate, the channel 12' can rotate as a whole. The working channel 12' includes a plurality of circular / elliptical openings 120 disposed around its outer periphery. The number and shape of the openings 120 are not particularly limited. Further, the openings 120 are sealed from other non-opening portions of the working channel 12' via the sealing rings 13a, 13b. The rings 13a, 13b are attached around the outer periphery of the portion of the working channel 12' adjacent to the opening 120, with one ring 13a attached distally of the opening 120 and the other ring 13b attached proximally of the opening 120. The rings 13a, 13b can be attached around the outer periphery of the working channel 12' such that they enable rotation of the channel 12' within the rings 13a, 13b while functioning as seals. The rings 13a, 13b can be formed of any suitable material used for sealing purposes, such as rubber.

[0041] The device 1''' further includes a tubular suction body 200 having one end attached to the outer periphery of a part of the working channel 12'. The suction body 200 includes a tube wall 201, a lumen 202, and a cavity 203. One end of the lumen 202 can be connected to at least one of a suction source (not shown) and a suction collection device (not shown). The other end of the lumen 202 is connected to the cavity 203 of the tubular suction body 200 surrounding a part of the working channel 12' including the opening 120. A part of the suction body 200 including the cavity 203 includes a proximal opening 204 and a distal opening 205. The openings 204, 205 cover the channel 12' and include rings 13a, 13b. In FIG. 4, a part of the suction body 200 including the cavity 203 is attached to the outer periphery of a part of the working channel 12' such that the cavity 203 and the opening 120 are sealed from the rest of the device 1'''. Thus, according to such a configuration, the suction body 200 can suction and remove substances, such as body fluids, captured in the portion of the working channel 12 distal to the opening 120. The substance may be discharged from the channel 12' through the opening 120 by suction and dropped into the lumen 201. According to such a configuration, it is possible to suction while introducing an accessory device, such as the accessory 3, through the port 11 and into the working channel 12'.

[0042] It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed device without departing from the scope of the invention. Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. The specification and examples are to be considered as exemplary only, and the true spirit and scope of the invention is to be determined by the following claims.

Claims

1. A shaft, A handle including a proximal portion and a distal portion, the distal portion being fixed to the proximal portion of the shaft, A channel extending from the handle into the shaft, including a proximal channel and a distal channel, the proximal channel being rotatable relative to the distal channel, and further the proximal channel being aligned with the distal channel during rotation of the proximal channel, Comprising, The proximal portion of the handle includes the proximal channel, the distal portion of the handle includes the distal channel, the distal portion of the handle is rotatable relative to the proximal portion of the handle, and the shaft is configured to rotate with the distal portion of the handle, a medical device.

2. The shaft surrounds at least a portion of the distal channel, and the distal channel is configured to rotate with the shaft and the distal portion of the handle, the medical device according to claim 1.

3. The distal portion of the handle is rotatable clockwise or counterclockwise relative to the proximal portion of the handle, the medical device according to claim 1 or 2.

4. The rotation of the distal portion of the handle is limited to rotation over a preset angle, the medical device according to any one of claims 1 to 3.

5. The distal portion of the handle is maintained in a stationary state relative to the proximal portion of the handle by frictional force generated by the contact between the surface of the distal portion of the handle and the surface of the proximal portion of the handle, the medical device according to any one of claims 1 to 4.

6. The handle further includes a guide, the guide includes a lumen extending along the central axis of the guide, the lumen is disposed between the proximal channel and the distal channel, and the lumen is aligned with the proximal channel and the distal channel, the medical device according to any one of claims 1 to 5.

7. The guide is fixed to the inner surface of the proximal portion of the handle, the medical device according to claim 6.

8. The distal portion of the handle further includes a support along the inner surface of the distal portion of the handle, and the proximal portion of the shaft is fixed to the support, the medical device according to any one of claims 1 to 7.

9. Further includes a lock having a first form and a second form, in the first form of the lock, the distal portion of the handle is stationary relative to the proximal portion of the handle, and in the second form of the lock, the distal portion of the handle is rotatable relative to the proximal portion of the handle. The medical device according to any one of claims 1 to 8.

10. The lock is a first washer including a pin protruding in the proximal direction, the first washer through which the distal channel extends through the opening of the first washer, and a second washer including a plurality of openings each configured to receive the pin, and a spring connecting based on the distal surface of the first washer. The medical device according to claim 9.

11. In the first form of the lock, the first washer is spring-biased toward the second washer such that the pin of the first washer engages with one of the plurality of openings of the second washer. In the second form of the lock, the first washer is spaced proximal to the second washer, compressing the spring, whereby the pin is disengaged from all of the plurality of openings. The medical device according to claim 10.

12. The lock further includes a tube, the tube extends through the openings of the first washer and the second washer, the tube covers at least a part of the distal channel, and the first washer is configured to move on the tube. The medical device according to claim 11.

13. Further includes a first steering wire and a first gyro for holding the first steering wire. The first gyro includes a proximal gyro and a distal gyro. The distal gyro is fitted with the proximal gyro such that the distal gyro is rotatable relative to the proximal gyro around the outer periphery of the distal channel or the proximal channel. The medical device according to any one of claims 1 to 12.

14. The first steering wire includes a proximal wire and a distal wire, a distal end of the proximal wire is connected to a first expansion part, a proximal end of the distal wire is connected to a second expansion part, the first expansion part is fixed to the proximal gyro, and the second expansion part is fixed to the distal gyro. The medical device according to claim 13.

15. The medical device according to claim 14, wherein when the proximal wire is tensioned via a driving device, the distal wire is configured to be tensioned.

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