阅读说明：本技术 可操纵医疗装置和方法 (Steerable medical devices and methods ) 是由 奥村一郎 加藤贵久 于 2018-04-27 设计创作，主要内容包括：用于可操纵医疗装置的设备、方法和系统,所述可操纵医疗装置构造成与医疗程序中的包括内窥镜、照相机、切割工具和导管在内的引导工具和装置一起使用。(Apparatus, methods, and systems for a steerable medical device configured for use with guidance tools and devices including endoscopes, cameras, cutting tools, and catheters in medical procedures.)

1. A medical device, comprising:

a bendable body having at least a first drive line configured in the bendable body;

an expansion unit, comprising:

a first shunt line attached to the first drive line; and

a retracting guide substantially surrounding the first drive wire along at least a portion of its longitudinal direction, the retracting guide being movable relative to the first drive wire; and

an actuator configured to retract and advance the first drive wire via the first dispensing line and configured to manipulate the bendable body;

wherein the contraction guide is movable along the longitudinal direction of the first drive wire.

2. The medical device of claim 1, wherein the bendable body has a channel around a center of the bendable body, and wherein a diameter of the channel is substantially the same before, during, and after manipulation of the bendable body.

3. The medical device of claim 2, wherein the channel is configured to receive various surgical tools selected from the group consisting of: biopsy tools, endoscopes, cutting tools, slicing tools, lights, derivatives thereof, and combinations thereof.

4. The medical device of claim 1, wherein the first drive wire extends to a distal end of the bendable body and is offset from a centerline of the bendable body.

5. The medical device of claim 1, further comprising a tap for accommodating the at least one tap line, wherein the tap comprises a guide tube for guiding the tap line.

6. The medical device of claim 1, wherein the retraction guide comprises a first spring parallel to and surrounding the first drive wire.

7. The medical device of claim 6, further comprising a second spring configured to surround the first spring and having a different helical direction than the first spring.

8. The medical device of claim 1, further comprising: a second drive line configured in the bendable body; a second tap line attached to the second drive line; and a second retraction guide substantially surrounding the second drive line, wherein the second shunt line is coupled with the actuator.

9. The medical device of claim 8, wherein the second drive line extends partially into the bendable body and is offset from a centerline of the bendable body.

10. The medical device of claim 8, wherein the actuator is configured to retract and advance the second drive wire via the second shunt wire.

11. The medical device of claim 8, wherein the second drive wire is configured in a different position relative to the bendable body than the first drive wire.

12. The medical device of claim 8, further comprising: at least a third spring parallel to and surrounding the second drive wire.

13. The medical device of claim 1, wherein a diameter of the first shunt wire is greater than a diameter of the first drive wire, and the first shunt wire is configured to push the contraction guide when the contraction guide contracts.

14. The medical device of claim 8, wherein a diameter of the second shunt wire is greater than a diameter of the second drive wire.

15. The medical device of claim 1, wherein the bendable body comprises:

at least two guide rings, wherein the at least two guide rings are arranged parallel to each other with a distance between them, each guide ring comprising at least one slit configured to accommodate at least the first drive line or the second drive line.

16. The medical device of claim 15, further comprising: a first spring parallel to and surrounding the first drive wire; and a second spring configured to surround the first spring and having a different spiral direction from the first spring.

17. The medical device of claim 5, wherein the tap is configured to increase an offset distance of the drive wire proximal to an actuator of the device.

18. The medical device of claim 1, wherein the actuator includes an actuation handle coupled with the first tap line such that manipulation of the actuation handle corresponds to bending of the bendable body.

19. The medical device of claim 8, further comprising: a third drive line configured in the bendable body; a third shunt line attached to the third drive line; and a third contraction guide substantially surrounding the third drive wire, wherein the third shunt wire is coupled with the actuator.

20. The medical device of claim 5, wherein the tap-off unit is configured to be detachable from the actuator unit.

21. The medical device of claim 17, wherein the third drive wire is configured in a different position relative to the bendable body than the first drive wire and the second drive wire.

22. A connector apparatus, comprising:

at least first and second drive wires extending from the connector apparatus and configured to drive a steerable device;

an expansion unit, comprising:

a first shunt line attached to the first drive line; and

a first contraction guide substantially surrounding the first drive wire along at least a portion of a longitudinal direction of the first drive wire, the first contraction guide being movable relative to the first drive wire;

a second shunt wire attached to the second drive line; and

a second contraction guide substantially surrounding the second drive wire along at least a portion of a longitudinal direction of the second drive wire, the second contraction guide being movable relative to the second drive wire; and

an actuator configured to retract and advance the first and second drive wires via the first and second tap wires, respectively, and configured to steer the steerable device;

wherein the first and second contraction guides are movable in longitudinal directions of the first and second drive wires, respectively.

23. The connector apparatus of claim 22, further comprising: a first spring parallel to and surrounding the first drive wire; and a third spring parallel to and surrounding the second drive wire.

24. The connector apparatus of claim 23, further comprising: a second spring configured to surround the first spring and having a different helical direction than the first spring; and a fourth spring configured to surround the third spring and having a different spiral direction from the third spring.

Technical Field

The present disclosure relates generally to apparatus and methods for medical applications, and more particularly to steerable medical devices that may be applied to guide tools and devices (including endoscopes, cameras, and catheters) in medical procedures.

Background

Flexible medical instruments such as endoscopic surgical devices and catheters are widely used in surgical and testing environments and continue to gain acceptance in the medical field. The medical device typically includes a flexible tube, commonly referred to as a sheath or sheath, with one or more tool channels extending along (typically internally of) the sheath to allow access to an end effector at the distal end of the sheath.

The device is designed to flexibly access a predetermined lesion area in a confined space in at least one curvilinear or more curvilinear path while maintaining torsional and longitudinal stiffness through a narrow passageway. The physician actuates the end effector at the distal end of the sheath by manipulating the proximal end of the device from outside the patient. Thus, actuation of the sheath from the distal end plays a key role for the following process: flexible access to the end-effector is ensured while providing physician controllability of the device, thereby assisting the physician in performing tests and/or manipulations on the patient.

For example, U.S. patent No.8365633 ("the' 633 patent") provides a push-pull actuated surgical device for surgery having a plurality of rod sheaths. Of the plurality of struts, a primary strut is centrally located and attached to the base plate and the end plate. The secondary struts are attached to the end disc and are equidistant from each other. To create the bending moment, the secondary struts are pushed and pulled against the end discs. The auxiliary strut is connected to and actuated by an actuation unit comprising a linear slide and an electric motor.

However, the prior art suffers from a number of drawbacks that limit and preclude the use of flexible medical devices. For example, the secondary strut in the' 633 patent is limited in size reduction because the secondary strut needs to pass through the free space between the sheath and the actuator. Since the independent length causes the second strut to be deformed in the pushing operation, the diameter of the auxiliary strut is limited to maintain sufficient rigidity against deformation. Therefore, the deformation of the auxiliary strut makes the miniaturization of the sheath difficult.

Furthermore, because the device cannot extend a long distance in free space due to the secondary struts in the' 633 patent, the actuator needs to be positioned near the proximal end of the secondary strut. This limitation of actuators makes it difficult to integrate multiple actuators and significantly limits the scope and usability of the device of the' 633 patent. In addition, the circumferential spacing of the secondary struts cannot be reduced due to mechanical interference of adjacent actuators. Therefore, the miniaturization of the sheath is further limited.

It would therefore be particularly beneficial to disclose a steerable medical device having a reduced overall diameter while enabling control of the steering of the device in three axes.

Disclosure of Invention

Accordingly, to address such exemplary needs in the industry, the devices, systems, and methods of the present disclosure teach a medical device for use in non-invasive surgical procedures, the medical device comprising: a bendable body for insertion into a patient, having at least a first driveline configured in the bendable body; and an expansion unit including a first branch line (break-out wire) attached to the first drive wire and a contraction guide movable relative to the first drive wire, wherein the first branch line is connected to an actuator configured to manipulate the bendable body.

In various embodiments, the first drive wire extends to the distal end of the bendable body and is offset from the centerline of the bendable body to allow a hollow passage through the center of the bendable body that allows conventional surgical tools and instruments to pass through the center of the bendable body so that the tools and instruments can reach the internal components of the patient.

In other embodiments of the present disclosure, the medical device may further include second, third, and/or additional drive wires configured in the bendable body and corresponding second, third, and/or additional shunt wires attached to the corresponding drive wires, wherein the second, third, and/or additional shunt wires are connected to the actuator, thereby allowing the actuator to manipulate the bendable body.

In other embodiments, the second, third, and/or additional drive lines can extend at least partially into the bendable body, wherein the second, third, and/or additional drive lines are offset from a centerline of the bendable body, thus leaving or facilitating a hollow passageway through the center of the bendable body.

In various embodiments of the present disclosure, the actuator is configured to independently retract and advance the first, second, third, and/or additional driveline by manipulating the corresponding first, second, third, and/or additional shunt wires.

In other embodiments, the medical device of the present disclosure includes at least one contraction guide parallel to the first drive wire for at least a portion of the first drive wire, wherein the contraction guide can be positioned around the first drive wire and can be further configured to contact the first drive wire.

In some embodiments, the retraction guide may be at least one primary coil spring parallel to the first drive wire, wherein the spring may be positioned around the first drive wire and may be further configured to contact the first drive wire. Additional springs may be utilized to surround the additional drive wire.

In various embodiments, the auxiliary coil spring may be incorporated into the contraction guide in combination with the main coil spring to surround the first drive wire such that the main coil spring and the auxiliary coil spring act on the first drive wire in combination with each other. In various embodiments, the main coil spring may be configured to follow a different helical direction than the auxiliary coil spring.

In various embodiments, the tap may be configured such that a diameter of the first tap line is larger than a diameter of the first drive line. Furthermore, the diameter of the second, third and/or additional tapping line may be larger than the diameter of the corresponding second, third and/or additional drive line.

In various embodiments, a tap-off unit for accommodating at least one tap-off line may comprise one or more guide tubes, wherein the guide tubes may have similar or different diameters. The guide tube may be configured to guide the branch line, for example, along a path defined by the guide tube.

In another embodiment of the device of the present disclosure, the bendable body may comprise a strut and at least two bending sections that may be configured on the strut, wherein the at least two bending sections are arranged parallel to each other and spaced apart by a distance, thereby creating a space for bending the at least two bending sections. Each bend section also includes at least two guide slits configured to accommodate at least a first drive line or a second drive line.

In various embodiments, the tap may be configured to increase the offset distance of the drive wire proximal to an actuator of the device. In various embodiments, the actuator includes an actuation handle coupled with the first tap line such that manipulation of the actuation handle corresponds to bending of the bendable body. In the case of additional branch lines and corresponding drive lines, the bendable body may be manipulated using an additional actuation handle dedicated to and attached to each branch line.

In other contemplated embodiments, the tap-off unit is configured to be detachable from the actuator unit. Further, the bendable body may be configured to be detachable from the tap-off unit.

These and other objects, features and advantages of the present disclosure will become apparent from the following detailed description of illustrative embodiments thereof, which is to be read in connection with the accompanying drawings and the provided paragraphs.

Drawings

Other objects, features and advantages of the present invention will become apparent from the following detailed description when taken in conjunction with the accompanying drawings which illustrate exemplary embodiments of the invention.

FIG. 1 depicts a side perspective view of a steerable medical device according to one or more embodiments of the present subject matter;

FIG. 2 is a front perspective view of a steerable medical device according to one or more embodiments of the present subject matter;

FIG. 3 provides a top perspective view of at least a portion of a steerable medical device according to one or more embodiments of the present subject matter;

FIG. 4 provides a top perspective view of at least a portion of a steerable medical device according to one or more embodiments of the present subject matter;

FIG. 5 depicts a side perspective view of at least a portion of a steerable medical device in detail, according to one or more embodiments of the present subject matter;

FIG. 6 illustrates a side perspective view of at least a portion of a steerable medical device, according to one or more embodiments of the present subject matter;

FIG. 7 depicts a side perspective view of a steerable medical device, according to one or more embodiments of the present subject matter;

FIG. 8 depicts a side perspective view of a steerable medical device, according to one or more embodiments of the present subject matter;

FIG. 9 provides a cross-sectional view of at least a portion of a steerable medical device according to one or more embodiments of the present subject matter;

FIG. 10 illustrates a cross-sectional view of at least a portion of a steerable medical device, according to one or more embodiments of the present subject matter;

FIG. 11 provides a photograph of an exemplary steerable medical device, according to one or more embodiments of the present subject matter;

FIG. 12 is a photograph providing at least a portion of an exemplary steerable medical device according to one or more embodiments of the present subject matter;

FIG. 13 is a photograph providing at least a portion of an exemplary steerable medical device according to one or more embodiments of the present subject matter;

fig. 14 is a photograph providing at least a portion of an exemplary steerable medical device according to one or more embodiments of the present subject matter.

Throughout the drawings, the same reference numerals and characters, unless otherwise specified, are used to designate like features, elements, components or portions of the illustrated embodiments. In addition, reference numerals comprising a reference numeral "'" (e.g., 12 ' or 24 ') denote auxiliary elements and/or reference numerals of the same nature and/or kind. Further, while the present disclosure will now be described in detail with reference to the accompanying drawings, the disclosure is accomplished in conjunction with the illustrative embodiments. It is intended that changes and modifications may be made to the described embodiments without departing from the true scope and spirit of the disclosed subject matter as defined by the following paragraphs.

Detailed Description

The present disclosure details a medical device that can be manipulated to guide through a passageway. More specifically, the medical devices of the present disclosure include lumens for receiving devices including endoscopes, cameras, and catheters and medical tools, as well as the ability to guide or steer the medical tools or devices through the channels.

Fig. 1 provides a side perspective view of a steerable medical device 10 according to one or more embodiments of the present subject matter. The steerable medical device 10 includes a bendable body 12, a tap unit 28, and an actuator 36. The bendable body 12 includes: at least two guide rings 14, said guide rings 14 housing at least two drive lines 16 and 16'; a flexible strut 18 for supporting the guide ring 14; and a slit 40 for each drive line 16 for guiding the drive lines 16. The guide ring 14 is hollow in the center and is secured to the post 18 at designed intervals by an adhesive layer 42. The combination of the guide ring 14 and the post 18 forms a channel 44 for receiving an auxiliary tool through the device 10. The bendable body 12 also defines a center of mass Q as the centerline of the tubular shape of the bendable body 12 with the proximal end C closer to the tap unit 28 and the distal end D further from the tap unit 28. The strut 18 may be mechanically fixed at the proximal end C and may be resiliently steerable along the centroid Q.

FIG. 2 further provides a front cross-sectional perspective view of the steerable medical device 10 provided in FIG. 1. Thus, the cross-sectional view of the bendable body 12 at the cross-section a-a (see fig. 1) shows the guide ring 14 in more detail, the guide ring 14 containing at least two guide slits 40 for guiding at least two drive wires 16. Fig. 2 shows in further detail the adhesive layer 42, the channel 44 for receiving an auxiliary tool and further defines a centroid Q.

Returning to fig. 1, the guide ring 14 may be secured to the strut 18 by an adhesive layer 42 and may retain the drive wires 16 and 16 'in the respective slots 40, while the drive wires 16 and 16' are free to slide along the guide slots 40. The drive lines 16 and 16' are free of any mechanical support structure between adjacent guide rings 14. The space between the guide rings 14 allows one guide ring 14 to be manipulated relative to the second guide ring 14, thereby manipulating the medical device 10.

The tap unit 28 includes a distal guide tube 22, a proximal guide tube 24, at least two tap lines 26 and 26', and a spring 46 (see fig. 5). Proximal guide tube 24 is mechanically fixed. Also, the distal guide tube 22 is fixed to the inner wall of the proximal guide tube 24. These distal guide tubes 22 and proximal guide tubes 24 form the proximal and distal regions of the eyelets 50 and 48, respectively (see FIG. 5).

Fig. 1 further illustrates an actuator 36, which actuator 36 may be configured near the patient and mechanically connected to the bendable body 12 by a tap 28. The actuator 36 includes a retractor 30 connected to the scoring line 26, as well as a lead screw 32 and motor 34 for advancing and retracting the scoring line 26 along the Q-axis. In this interval, the tap line 26 passes through free space and remains straight.

As shown in fig. 3 and 4, the drive wires 16 and 16' are secured to the guide ring 14 at different locations by fasteners 58. Specifically, the drive wire 16 is secured to the first guide ring 14 at location E by a fastener 58, while the drive wire 16 'is secured to the second guide ring 14 at location F by a fastener 58'. The remainder of each drive line 16 and 16' extends freely through the respective guide slot 40 until they reach the tap unit 28. The fasteners 58 and 58' may be attached to the respective guide rings by mechanical, chemical, and/or sonic welding. At these end positions E and F, the bendable body 12 is divided into two bending sections 100 and 100', which two bending sections 100 and 100' are substantial bending areas, including the assembly of the strut 18, the drive wire 16 or 16' and all the guide rings 14 in this area. In fig. 3 and 4, we observe two different embodiments of the steerable medical device 10 of the present disclosure, where fig. 3 depicts a left arc S-shaped bend that is achieved by first retracting the drive wire 16' and then retracting the drive wire 16. The right arc sigmoid bend in fig. 4 is achieved by advancing the drive line 16' first and then advancing the drive line 16. In other words, when the motor 34 retracts the drive line 16, the curved section between the positions E and F curves in the direction of the drive line 16 (fig. 3). Also, when the drive line 16 advances, the bending section between the positions E and F may be bent in the opposite direction (fig. 4). In the same way, when the drive line 16 'is retracted, the bending section between positions F and G bends in the direction of the drive line 16', while when advanced, the bending section bends in the opposite direction. At the bending section between positions F and G, the bending moments from the drive lines 16 and 16 'interfere with each other, but by selecting an appropriate actuation force for the drive lines 16 and 16', the bending section between positions F and G can be bent independently. Thus, by using two or more drive lines, two or more corresponding bending sections may be bent independently. It will be appreciated that additional drive lines and bendable bodies may be added to additional bending sections, which will result in additional independent bending.

As shown in fig. 5, the proximal end of the drive wire 16 is connected to the tap 28 by attaching the drive wire 16 to the tap wire 26. The proximal region of the eyelet 50 includes the drive wire 16 and the tap wire 26 and mechanically guides the tap wire 26 along the Q-axis. The proximal region of the eyelet 50 may include a spring 46, exemplified herein as a coil spring, for guiding the drive wire 16 along the Q-axis. The spring 46 may touch the distal guide tube 22 and the tap line 26 at both ends. As the drive wire 16 extends through the tap wire 26, the spring 46 contracts between the distal guide tube 22 and the tap wire 26. At the same time as the spring 46 is compressed, the spring 46 acts to guide the drive wire 16, wherein the inner diameter is substantially the same compared to the diameter before the spring 46 is compressed. Therefore, the drive wire 16 is retracted and advanced without being deformed via the branch wire 26.

Further, as the tap wire 26 advances, the spring 46 stabilizes the movement of the tap wire 26 and the drive wire 16 with the restoring force of the spring 46 from undesired mechanical movement caused by backlash in moving components (e.g., the retractor 30 and the lead screw 32 in the actuator unit 36).

Since the tap unit 28 comprises one or more springs 46, the diameter of the drive wire can be reduced without causing deformation. The tap unit with the spring 46 may avoid deformation of the drive wire 16 when an actuation force is transmitted from the actuator unit 36, particularly in the area of connection from the bendable body 12 to the actuator unit 36. With the reduced diameter of the drive wire 16, the outer diameter of the bendable body 12 may be minimized while maximizing the size of the tool passage 44 in the bendable body 12. Thus, the bendable body 12 can reduce invasiveness in treatment and can increase the range of use of tools. Furthermore, by converting the drive wire 16 to a tap wire 26 having a larger diameter, the tap unit 28 may improve the positional alignment tolerance between the drive wire 16 and the motor 34 (or handle) in the actuator unit 36. The shunt wire 26 may transmit a retraction/advancement force with a curvature that adjusts for misalignment of the direction from the motor 34 and handle 52 to the drive wire 16. Thus, the actuator unit 36 reduces manufacturing, assembly, and maintenance costs and increases operational reliability, thereby avoiding failure due to misalignment.

Moreover, by housing the drive wire 16 with the proximal guide tube 24 at the proximal end, the exposed area of the drive wire 16 at the proximal end may be reduced and protected from damage caused by external environments (e.g., mechanical impact, abrasion, moisture, harsh chemical environments, etc.). Even a local damage in the drive line 16 may become a starting point at which the drive line 16 is deformed and/or the drive line 16 is disconnected.

Finally, since the tap wire 26 has a larger diameter than the drive wire 16, the tap wire 26 can pass through a longer free space without being deformed to be finally connected to the actuator 36 (or handle). Thus, the actuator 36 (or handle) connected to the tap line 26 may be configured to have a greater variety of layout options, particularly with respect to the direction of the center of mass. These layout choices allow minimizing the size of the actuator unit 36 and increasing the number of actuators connected to the drive line 16.

In various embodiments, multiple springs 46 may be used in conjunction with the steerable medical device 10 of the present application. Fig. 6 illustrates the use of a second spring 46' configured to be concentric with the first spring 46. The two springs 46 and 46' fill the proximal region of the aperture 50 and mechanically guide the drive wire 16. In this embodiment, the springs 46 and 46' are coil springs, and the springs 46 and 46' also have opposite coil directions to each other, thereby avoiding tangling of the springs 46 and 46 '. By having two or more springs 46 and 46', the springs can avoid reducing mechanical compliance when the diameter of the drive wire 16 is miniaturized. Although coil springs have been described, it is contemplated that one or both of the coil springs 46 and 46' may be replaced and/or enhanced with other resilient devices, including leaf springs, tensioning elements, and the like.

By utilizing multiple coil springs 46, the drive wire 16 can be switched to a tap wire 26 having a larger diameter, thereby maintaining the proper stiffness of the springs 46. Thus, the tap 28 may be shortened along the centroidal axis.

Further, the coil spring 46 may prevent the smaller diameter drive wire 12 from being deformed because the effective inner diameter of the spring 46 against the drive wire 12 may be adjusted by adding the smaller diameter coil spring 46 to the inside of the existing spring 46. Accordingly, the tap-off unit 28 may actuate a smaller bendable body and may reduce invasiveness in treatment, thereby increasing the range of surgical tools that may be used.

The motors 12 can be placed in sequence along the Q-axis by extending the tap line 26. Since the tap unit 28 converts the diameter of the drive lines 16 and 16' into the diameter of the tap lines 26 and 26', a suitable diameter of the tap lines 26 and 26' may be designed to allow the tap lines 26 and 26' to extend to the motor 12 without deforming the tap lines 26 and 26 '. Thus, the present disclosure can eliminate the problem of drive line 16 and 16 'deformation from the layout design of the motor 12 and allow actuation of the miniaturized curved body 12 through much thinner diameter drive lines 16 and 16'.

In addition, the diameter of the tap line 26 may be selected to be sufficiently robust to eliminate any damage associated with misalignment of the retractor 30 (fig. 7). Misalignment (H) of the retractor 30 in fig. 7 can be tolerated by deflecting and not deforming the dispensing line 26. Thus, the present invention may increase the tolerance of the position of the retractor 30 relative to the proximal guide tube 24, and may allow for reduced positional calibration and countermeasures against misalignment caused by environmental factors (e.g., temperature, thermal cycling, and humidity).

Furthermore, the robustness against misalignment of the steerable medical device 10 allows for a mechanical interface between the tap wire 26 and the retractor 30 (which allows for replacement of the bendable body 12) and a mechanical interface between the tap unit 28 and the reusable actuator unit 36. The robustness against misalignment of the steerable medical device 10 can accommodate positional changes in the case of attachment, detachment, and reattachment of various different individual components, further extending the utility and advantages of the present disclosure. In particular, steerable medical devices may be developed as sterile, disposable tools and tools for a limited number of uses after a sterilization process.

Fig. 8-10 provide various views of a steerable medical device 10 employing a tapered tap unit 28 and a manually operated actuator unit 36. Fig. 8 is a side view of the steerable medical device 10. Fig. 9 and 10 are cross-sectional views of the medical device 10 at lines I-I and J-J. In this embodiment, the tap unit 28 tapers from the proximal side to the distal side. The distal end of the tap 28 gradually increases the offset O of the drive lines 16 and 16 'to the offset P of the tap lines 26 and 26'. At the same time, the circumference of the circular layout of the tap-off units 28 also increases from the circumference R to the circumference S.

The actuator unit 36 includes a rotary handle 52, the rotary handle 52 being manually manipulable by an end user. The rotating handle 52 includes handle eyelets (not shown) and retains the tap lines 26 and 26'. The tapping lines 26 and 26' can be slid along the handle eyelets. The drive line 16, which ends at position K, is connected to the rotary handle at position N via a tapping line 26. Furthermore, the drive line 16 'ending at the position L is connected to the rotary handle at the position M via a tapping line 26'.

The rotational handle 52 is similar in construction to the bendable body 12. The rotating handle 52 is supported by an elastic tube (not shown) and can be bent like the bendable body 12. Upon bending, each handle 52 may rotate the tap lines 26 and 26'. Specifically, the rotation handles 52 at positions M and N determine the bending angles of the bendable body 12 at positions K and L, respectively. Rotating the handle 52 may control the bend angle of multiple bend sections with multiple tap lines by using similar multiple bend sections.

More specifically, since the offset amount R of the driving wires 16 and 16 'is increased to the offset amount S of the branch wires 26 and 26', the control angle of the rotation handle 52 can be configured to be smaller than the bending angle of the bendable body 12. The ratio of the bending angle of the bendable body 12 to the control angle of the rotary handle 52 is inversely proportional to the ratio of the offset amount R to the offset amount S. In addition, these ratios may be adjusted to allow more or less limited control of the bendable body 12, further increasing the utility of the steerable medical device 10 of the present invention.

By designing the tap 28 to increase the offset distance of the drive line 16, the tap 28 can make sufficient circumferential spacing for the split line 26 when the circumferential spacing of the drive line 16 in the bendable body 12 results in mechanical interference between adjacent split lines 26, and can actuate bendable bodies 12 having smaller outer diameters. Thus, the bendable body 12 can reduce invasiveness in use and, due to the smaller diameter required for the bendable body 12, allow for an expanded range of tools that can be inserted into the bendable body 12.

Furthermore, the ability to disconnect the bendable body 12 and connect it to the tap unit 29 allows for independent sterilization of various portions of the steerable medical device 10. Thus, the curved body 12 can be sterilized easily and economically without sterilizing the actuator unit 36 and/or the tap unit 28. Furthermore, the bendable body 12 may be disposable, while the actuator unit 36 and/or the tap unit 28 are reusable.

Furthermore, the tap-off units 28 may be repeatedly connected in series, which may further increase the circumferential spacing in multiple stages to reduce friction losses and deformation risks in the gap.

Moreover, in conjunction with the rotation handle 52 as an actuator unit, this increased offset distance reduces the angle of rotation of the rotation handle 52 to achieve the target bending angle of the bendable body 12. Therefore, the user can achieve a target bending angle with a smaller operation stroke.

The rotational actuation handle 52 allows an operator to manually actuate the bendable body 12 by using a rotational motion in a plane corresponding to the plane of bending of the bendable body 12, the handle 52 can actuate multiple drive wires 16 in a simple small structure. When the bendable body 12 using multiple drive wires 16 produces multiple sections that bend along the center of mass, the handle 52 can be configured with series elements of independent rotational motion to control the multiple sections to bend individually. Also, when the bendable body 12 having a plurality of drive wires 16 includes multiple bends in one bending section, the handle 52 can be configured with multiple elements of rotational motion. Thus, the actuator unit 36 may be miniaturized, thereby making the steerable medical device 10 movable and easy to construct and operate in any desired place.

The rotary actuator handle 52 may be connected to the actuator and have the ability to disconnect and connect the entire structure between the bendable body 12 and the rotary actuator handle 52 to the actuator. In this embodiment, the drive and tap lines 16, 26 may be encapsulated and may be protected from damage caused by the external environment, such as mechanical impact, abrasion, moisture, harsh chemicals, and the like.

The embodiment of the present disclosure provided as a picture in fig. 11 and 12 has a similar configuration to the steerable medical device in fig. 1 and 2. However, the curved body 12 includes six curved sections. Fig. 11 is a perspective view of a steerable medical device 10, and fig. 12 is a top view of a bendable body 12 having six bending sections. The steerable medical device 10 in this embodiment includes a motor circuit 54 having a plurality of motors 34, a retractor 30, an intermediate shaft 56, and a bendable body 12. The intermediate shaft 56 corresponds to the tap unit 28. The actuator unit 36 corresponds to the motor circuit 54 and the retractor 30. The six bendable sections are implemented by six sets of drive lines and guide rings attached to the drive lines at staggered locations. In addition, each of the six drive wires would require an actuator to facilitate independent bending of the medical device 10 by retraction or advancement of each drive wire.

Fig. 13 provides a picture of an exemplary bendable body 12 according to one or more embodiments of the present subject matter. The bendable body 12 provided in fig. 13 is provided in two sizes. One example ("a") has an outer diameter of 3.4mm and guide rings with a spacing of 0.25 mm. Example a also includes a tool channel 44 having a diameter of 1.4 mm. The second example ("B") had an outer diameter of 1.7mm and a guide ring spacing of 0.2 mm. Both examples have struts made of superelastic titanium nickel alloy. The struts are machined by laser cutting and include integral bending flexures at locations between adjacent guide rings so that the bendable body 12 can be bent in a bending plane.

By incorporating multiple bending sections, the steerable medical device 10 can control the position of the tip of the bendable body 12 with a deeper accessible area and wider selection of orientations of the tip of the bendable body 12. Also, by using multiple curvatures in the body 12, the bendable body 12 can reach a target through a complex path.

Fig. 14 shows a close-up view of the drive line 16 connected to the tap line 26. Here, a drive line 16 of 0.12mm diameter is connected to a tap line 26 of 0.35mm diameter. The drive wire 16 is inserted into the tap wire 26 and secured with an adhesive. Two coil springs 46 and 46' are located around the drive wire and prevent the drive wire 16 from deforming. In the image provided in FIG. 14, the outer spring 46 and the inner spring 46' have been partially separated to better illustrate their relationship to each other and to the bendable body 12. It can be seen that the helical direction of the springs 46 and 46' is clockwise and counter-clockwise, respectively. A drive wire 16 having a length of 100mm and a diameter of 0.12mm has been shown to deliver a target thrust (>5N) using the exemplary steerable medical device 10.