Steerable medical devices and methods

Abstract

Devices, methods, and systems for steerable medical devices configured for use with guide tools and devices in medical procedures including endoscopes, cameras, cutting tools, and catheters.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 62 / 500723, filed May 3, 2017, with the United States Patent and Trademark Office, the entire disclosure of which is incorporated herein by reference. Technical Field

[0003] This disclosure generally relates to devices and methods for medical applications, and more specifically to manipulable medical devices (including endoscopes, cameras, and catheters) that can be used as guides and apparatus in medical procedures. Background Technology

[0004] Flexible medical devices, such as endoscopic surgical devices and catheters, are widely used in surgical and laboratory settings and continue to gain acceptance in the medical field. These devices typically comprise a flexible tube, generally referred to as a cannula or sheath, with one or more tool channels extending along the sheath (usually inside) to allow access to an end effector located at the distal end of the sheath.

[0005] The device is designed to flexibly approach a predetermined lesion area in a confined space via at least one or more curved paths, while maintaining torsional and longitudinal stiffness through narrow pathways. The physician actuates the end effector located distal to the sheath by manipulating the proximal end of the device from outside the patient. Therefore, distal actuation of the sheath plays a crucial role in ensuring flexible access to the end effector while maintaining physician control over the device, thereby aiding in patient examination and / or manipulation.

[0006] For example, U.S. Patent No. 8,365,633 (“633 Patent”) provides a push-pull actuated surgical device for use in surgery, having a multi-strut sheath. Of the multiple struts, a primary strut is centrally located and attached to a base plate and an end plate. Secondary struts are attached to the end plates and are equidistant from each other. To generate a bending moment, the secondary struts are pushed or pulled against the end plates. The secondary struts are connected to and actuated by an actuation unit comprising linear sliders and electric motors.

[0007] However, existing technologies have many drawbacks that limit and hinder the use of flexible medical devices. For example, the auxiliary strut in the '633 patent is limited in terms of size reduction because it needs to pass through the free space between the sheath and the actuator. Since this independent length causes deformation of the second strut during push-operation, the diameter of the auxiliary strut is limited to maintain sufficient stiffness to prevent deformation. Therefore, the deformation of the auxiliary strut hinders the miniaturization of the sheath.

[0008] Further, due to the auxiliary struts in the '633 patent, the device cannot be extended for long distances in free space, and thus the actuators need to be positioned close to the proximal end of the auxiliary struts. This limitation of the actuators results in difficulty in integrating multiple actuators and significantly limits the range and usability of the '633 patent device. Additionally, the circumferential spacing of the auxiliary struts cannot be reduced due to mechanical interference of adjacent actuators. Thus, the miniaturization of the sheath is further limited.

[0009] Accordingly, it is particularly beneficial to disclose a steerable medical device that has a reduced overall diameter while enabling control of the device's steering in three axes. SUMMARY

[0010] Accordingly, to address this exemplary need in the industry, the apparatuses, systems, and methods of the present disclosure teach a medical device for use in a non-invasive surgical procedure, the medical device comprising: a bendable body for insertion into a patient, the bendable body having at least a first drive wire configured therein; and an extension unit, the extension unit comprising a first break-out wire attached to the first drive wire and a retraction guide movable relative to the first drive wire, wherein the first break-out wire is connected to an actuator configured to steer the bendable body.

[0011] In various embodiments, the first drive wire extends to a distal end of the bendable body and is offset from a centerline of the bendable body to allow a hollow passageway through the center of the bendable body, the hollow passageway allowing conventional surgical tools and instruments to pass through the center of the bendable body so that the tools and instruments can reach internal elements of the patient.

[0012] In other embodiments of the present disclosure, the medical device can further comprise second, third, and / or additional drive wires configured in the bendable body and corresponding second, third, and / or additional break-out wires attached to the corresponding drive wires, wherein the second, third, and / or additional break-out wires are connected to the actuator, thereby allowing the actuator to steer the bendable body.

[0013] In other embodiments, the second, third, and / or additional drive wires can extend at least partially into the bendable body, wherein the second, third, and / or additional drive wires are offset from the centerline of the bendable body, thus preserving or facilitating the hollow passageway through the center of the bendable body.

[0014] In various embodiments of the present disclosure, the actuator is configured to independently retract and advance the first, second, third, and / or additional drive wires by steering the corresponding first, second, third, and / or additional break-out wires.

[0015] 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.

[0016] In some embodiments, the contraction guide can be at least one primary helical spring parallel to the first drive wire, wherein the spring can be positioned around the first drive wire and can be further configured to contact the first drive wire. Additional springs can be utilized around additional drive wires.

[0017] In various embodiments, an auxiliary helical spring can be incorporated into the contraction guide in conjunction with the primary helical spring to surround the first drive wire, such that the primary helical spring and the auxiliary helical spring act in conjunction with each other on the first drive wire. In various embodiments, the primary helical spring can be configured in a different helical direction than the auxiliary helical spring.

[0018] In various embodiments, the tapping unit can be configured such that the first tapping wire has a larger diameter than the first drive wire. Further, the second, third, and / or additional tapping wires can have a larger diameter than the corresponding second, third, and / or additional drive wires.

[0019] In various embodiments, the tapping unit for housing at least one tapping wire can include one or more guide tubes, wherein the guide tubes can have similar or different diameters. The guide tubes can be configured to guide the tapping wires, for example along a path defined by the guide tubes.

[0020] In another embodiment of the device of the present disclosure, the bendable body can include a stem and at least two bending segments configured on the stem, wherein the at least two bending segments are arranged parallel to each other and spaced apart by a distance, thereby creating a space for bending the at least two bending segments. Each bending segment further includes at least two guide slots configured to house at least the first drive wire or the second drive wire.

[0021] In various embodiments, the tapping unit can be configured to increase the offset distance of the drive wires proximally of the actuator of the device. In various embodiments, the actuator includes an actuation handle coupled with the first tapping wire, such that manipulation of the actuation handle corresponds to bending of the bendable body. In the case of additional tapping wires and corresponding drive wires, the bendable body can be manipulated using additional actuation handles specific to each tapping wire and attached to each tapping wire.

[0022] In other contemplated embodiments, the tapping unit is configured to be detachable from the actuator unit. Further, the bendable body can be configured to be detachable from the tapping unit.

[0023] These and other objects, features, and advantages of the present disclosure will become apparent in light of the following detailed description of exemplary embodiments thereof, described in conjunction with the drawing figures. BRIEF DESCRIPTION OF DRAWINGS

[0024] Other objects, features, and advantages of the present application will become apparent in light of the following detailed description of exemplary embodiments thereof, described in conjunction with the drawing figures.

[0025] Figure 1 depicts a side perspective view of a steerable medical device according to one or more embodiments of the present subject matter;

[0026] Figure 2 is a front perspective view of a steerable medical device according to one or more embodiments of the present subject matter;

[0027] Figure 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;

[0028] Figure 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;

[0029] Figure 5 depicts 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 in detail;

[0030] Figure 6 depicts 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;

[0031] Figure 7 depicts a side perspective view of a steerable medical device according to one or more embodiments of the present subject matter;

[0032] Figure 8 depicts a side perspective view of a steerable medical device according to one or more embodiments of the present subject matter;

[0033] Figure 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;

[0034] Figure 10 depicts 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;

[0035] Figure 11 provides a photograph of an exemplary steerable medical device according to one or more embodiments of the present subject matter;

[0036] Figure 12is a photograph providing at least a portion of an example steerable medical device according to one or more embodiments of the present subject matter;

[0037] Figure 13 is a photograph providing at least a portion of an example steerable medical device according to one or more embodiments of the present subject matter;

[0038] Figure 14 is a photograph providing at least a portion of an example steerable medical device according to one or more embodiments of the present subject matter.

[0039] In all of the drawings, unless otherwise noted, like reference numerals and characters are used to denote like features, elements, components or parts throughout the illustrated embodiments. Additionally, reference numerals including a leading apostrophe (e.g., 12') or a prime symbol (e.g., 24') denote secondary elements and / or reference numerals of the same nature and / or kind. Furthermore, although the present disclosure will now be described in detail with reference to the drawings, the disclosure is completed in conjunction with the illustrative embodiments. Changes and modifications can be suggested to the described embodiments, and it is the intent that the disclosure encompass such changes and modifications as fall within the true scope and spirit of the disclosed subject matter defined by the appended paragraphs. DETAILED DESCRIPTION

[0040] The present disclosure details a medical device capable of being steered to guide through a passageway. More specifically, the medical device of the present disclosure includes a lumen for receiving devices including endoscopes, cameras, and catheters, and medical tools, and the ability to guide or steer the medical tools or devices through a passageway.

[0041] Figure 1 A side perspective view of a steerable medical device 10 according to one or more embodiments of the present subject matter is provided. The steerable medical device 10 includes a bendable body 12, a breakout unit 28, and an actuator 36. The bendable body 12 includes at least two guide rings 14 that house at least two drive wires 16 and 16', a flexible strut 18 for supporting the guide rings 14, and a slot 40 for each drive wire 16 for guiding the drive wire 16. The center of the guide rings 14 is hollow and secured to the strut 18 by an adhesive layer 42 at a designed interval. The assembly of the guide rings 14 in combination with the strut 18 forms a passageway 44 for receiving an auxiliary tool through the device 10. The bendable body 12 also defines a center of mass Q as a centerline of the tubular shape of the bendable body 12 with a proximal end C closer to the breakout unit 28 and a distal end D further away from the breakout unit 28. The strut 18 is mechanically fixed at the proximal end C and elastically steerable along the center of mass Q.

[0042] Figure 2 Further provided is Figure 1 A front cross-sectional perspective view of the steerable medical device 10 provided in FIG. 4 is provided. Thus, the bendable body 12 in cross-section A-A (seeFigure 1 A cross-sectional view at the location of the guide ring 14 further in detail shows the guide ring 14 comprising at least two guide slits 40 for guiding at least two drive lines 16. Figure 2 The adhesive layer 42, the channel 44 for receiving an auxiliary tool and the further defined center of mass Q are shown in further detail.

[0043] Returning to Figure 1 , the guide ring 14 can be fixed to the strut 18 by the adhesive layer 42 and can hold the drive lines 16 and 16' in the respective slit 40, while the drive lines 16 and 16' are free to slide along the guide slit 40. Between adjacent guide rings 14, the drive lines 16 and 16' are free of any mechanical support structure. The space between the guide rings 14 allows for manipulating one guide ring 14 relative to the second guide ring 14 and thus for manipulating the medical device 10.

[0044] The breakout unit 28 comprises a distal guide tube 22, a proximal guide tube 24, at least two breakout lines 26 and 26' and a spring 46 (see Figure 5 ). The proximal guide tube 24 is mechanically fixed. Moreover, the distal guide tube 22 is fixed to the inner wall of the proximal guide tube 24. These distal and proximal guide tubes 22 and 24 form the proximal and distal regions of the eyelets 50 and 48, respectively (see Figure 5 ).

[0045] Figure 1 Further shown is the actuator 36 which can be constructed in the vicinity of the patient and is mechanically connected to the bendable body 12 by the breakout unit 28. The actuator 36 comprises a puller 30 connected to the breakout line 26, and a lead screw 32 and a motor 34 for advancing and retracting the breakout line 26 along the Q-axis. In this interval, the breakout line 26 passes through the free space and remains straight.

[0046] As shown in Figure 3 and Figure 4 , the drive lines 16 and 16' are fixed to the guide rings 14 at different locations by fasteners 58. In particular, the drive line 16 is fixed to the first guide ring 14 at location E by a fastener 58, while the drive line 16' is fixed to the second guide ring 14 at location F by a fastener 58'. The remaining portions of each drive line 16 and 16' freely extend through the respective guide slit 40 until they reach the breakout unit 28. The fasteners 58 and 58' can be attached to the respective guide rings by mechanical, chemical and / or sonic welding means. At these termination locations E and F, the bendable body 12 is divided into two curved segments 100 and 100' which are substantial curved regions including the assembly of strut 18, drive line 16 or 16' and all guide rings 14 in this region. In Figure 3and Figure 4 In this study, we observed two different implementations of the steerable medical device 10 of this disclosure, wherein Figure 3 The left-hand S-shaped curve is depicted, achieved by first retracting drive line 16', and then retracting drive line 16. This is achieved by first advancing drive line 16', and then advancing drive line 16. Figure 4 The right arc S-shaped bend. In other words, when the motor 34 retracts the drive line 16, the bending section between positions E and F bends towards the drive line 16. Figure 3 Similarly, as drive line 16 advances, the curved section between positions E and F can bend in the opposite direction. Figure 4 Similarly, when drive line 16' retracts, the bending segment between positions F and G bends in the direction of drive line 16', and when it moves forward, the bending segment bends in the opposite direction. At the bending segment between positions F and G, the bending moments from drive lines 16 and 16' interfere with each other, but by selecting appropriate actuation forces for drive lines 16 and 16', the bending segment between positions F and G can bend independently. Therefore, by using two or more drive lines, two or more corresponding bending segments can be bent independently. It is understood that additional drive lines and bendable bodies can be added to additional bending segments, which will result in additional independent bending.

[0047] like Figure 5 As shown, the proximal end of drive line 16 is connected to tap unit 28 by attaching drive line 16 to tap 26. The proximal region of aperture 50 includes drive line 16 and tap 26, and mechanically guides tap 26 along the Q-axis. The proximal region of aperture 50 may include spring 46, exemplified herein as a helical spring, for guiding drive line 16 along the Q-axis. Spring 46 may contact distal guide tube 22 and tap 26 at both ends. As drive line 16 extends through tap 26, spring 46 contracts between distal guide tube 22 and tap 26. While spring 46 is compressed, it also guides drive line 16, wherein the inner diameter is substantially the same as the diameter before compression. Therefore, drive line 16 retracts and advances via tap 26 without deformation.

[0048] Furthermore, as tap line 26 moves forward, spring 46 stabilizes the movement of tap line 26 and drive line 16 using its restoring force, preventing undesirable mechanical movement caused by recoil from moving parts (e.g., traction device 30 and guide screw 32 in actuator unit 36).

[0049] Because the tap unit 28 includes one or more springs 46, the diameter of the drive wire can be reduced without causing deformation. The tap unit with springs 46 can avoid deformation of the drive wire 16 when transmitting the actuation force from the actuator unit 36, particularly in the connection region from the bendable body 12 to the actuator unit 36. With the drive wire 16 reduced in diameter, the outer diameter of the bendable body 12 can be minimized while the size of the tool channel 44 in the bendable body 12 can be maximized. Thus, the bendable body 12 can reduce invasiveness in treatment and enable an increased range of tools to be used. In addition, by converting the drive wire 16 to the tap wire 26 having a larger diameter, the tap unit 28 can improve the positional alignment tolerance between the drive wire 16 and the motor 34 (or handle) in the actuator unit 36. The tap wire 26 can transmit the retraction / advancement force with a curvature that adjusts for misalignment of the direction of the force from the motor 34 and handle 52 to the drive wire 16. Thus, the actuator unit 36 reduces manufacturing, assembly, and maintenance costs and improves the reliability of operation, thereby avoiding malfunctions caused by misalignment.

[0050] Furthermore, by containing the drive wire 16 at the proximal end with the proximal guide tube 24, the exposed area of the drive wire 16 at the proximal end can be reduced, and the exposed area can be protected from damage caused by the external environment (e.g., mechanical impact, abrasion, moisture, harsh chemical environment, etc.). Even a local damage in the drive wire 16 can become a starting point for deformation of the drive wire 16 and / or disconnection of the drive wire 16.

[0051] Finally, because 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 deformation to be ultimately connected to the actuator 36 (or handle). Thus, the actuator 36 (or handle) connected to the tap wire 26 can be configured to have a greater variety of layout options, particularly with respect to the direction of the center of mass. These layout options allow the size of the actuator unit 36 to be minimized and the number of actuators connected to the drive wire 16 to be increased.

[0052] In various embodiments, a plurality of springs 46 can be used in conjunction with the steerable medical device 10 of the present application. Figure 6A second spring 46' configured concentrically with the first spring 46 is shown. The two springs 46 and 46' fill the proximal region of the eyelet 50 and mechanically guide the drive wire 16. In this embodiment, the springs 46 and 46' are helical springs, and the springs 46 and 46' also have helical directions opposite to each other, thereby avoiding entanglement of the springs 46 and 46'. By having two or more springs 46 and 46', the springs can avoid reducing the mechanical compliance when the diameter of the drive wire 16 is miniaturized. Although a helical spring has been described, it is conceivable that other elastic means, including a leaf spring, a tension element, and the like, can be used instead of and / or in addition to one or both of the helical springs 46 and 46'.

[0053] By utilizing multiple helical springs 46, the drive wire 16 can be converted to a tap line 26 having a larger diameter, thereby maintaining the proper stiffness of the spring 46. Thus, the tap unit 28 can be shortened along the centroid axis.

[0054] Further, the helical spring 46 can prevent the deformation of the drive wire 12 of a smaller diameter, because the effective inner diameter of the spring 46 against the drive wire 12 can be adjusted by adding a smaller diameter helical spring 46 to the inside of the existing spring 46. Thus, the tap unit 28 can actuate a smaller bendable body, and can reduce invasiveness in treatment, thereby increasing the range of surgical tools that can be used.

[0055] By extending the tap line 26, the motor 12 can be sequentially placed along the Q-axis. Since the tap unit 28 converts the diameter of the drive wires 16 and 16' to the diameter of the tap lines 26 and 26', the proper diameter of the tap lines 26 and 26' can be designed so that the tap lines 26 and 26' extend to the motor 12 without deforming the tap lines 26 and 26'. Thus, the present disclosure can eliminate the problem of deformation of the drive wires 16 and 16' from the layout design of the motor 12, and allow the miniaturized bendable body 12 to be actuated by the drive wires 16 and 16' of much finer diameter.

[0056] Further, the diameter of the tap line 26 can be selected to have sufficient robustness to eliminate any damage related to misalignment of the tractor 30 Figure 7 ). The misalignment (H) of the tractor 30 in the Figure 7 can be allowed by deflecting the tap line 26 without deforming it. Thus, the present disclosure can increase the tolerance of the position of the tractor 30 with respect to the proximal guide tube 24, and can allow the reduction of the countermeasures for misalignment due to environmental factors such as temperature, thermal cycles, and humidity.

[0057] Furthermore, the robustness of steerable medical device 10 against misalignment allows for a mechanical interface between tap line 26 and puller 30 (which allows for replacement of bendable body 12) and a mechanical interface between tap unit 28 and reusable actuator unit 36. The robustness of steerable medical device 10 against misalignment can accommodate positional changes with various different attachment, detachment, and re-attachment of individual components, further expanding the utility and advantages of the present disclosure. In particular, steerable medical devices can be developed as sterile, single-use tools as well as tools for a limited number of uses after a sterilization process.

[0058] Figure 8 to Figure 10 Various views of steerable medical device 10 employing a tapered tap unit 28 and a manually operated actuator unit 36 are provided. Figure 8 is a side view of steerable medical device 10. Figure 9 and Figure 10 are cross-sectional views of medical device 10 at lines I-I and J-J. In this embodiment, tap unit 28 tapers from proximal to distal. The distal end of tap unit 28 gradually increases the offset O of drive lines 16 and 16' to the offset P of tap lines 26 and 26'. At the same time, the circumference of the circular layout of tap unit 28 also increases from circumference R to circumference S.

[0059] Actuator unit 36 includes a rotating handle 52 that can be manually manipulated by an end user. Rotating handle 52 includes a handle eyelet (not shown) and holds tap lines 26 and 26'. Tap lines 26 and 26' can slide along the handle eyelet. Via tap line 26, drive line 16, which terminates at position K, is connected to the rotating handle at position N. Furthermore, via tap line 26', drive line 16', which terminates at position L, is connected to the rotating handle at position M.

[0060] Rotating handle 52 is structurally similar to bendable body 12. Rotating handle 52 is supported by an elastic tube (not shown) and can bend like bendable body 12. Upon bending, each handle 52 can rotate tap lines 26 and 26'. In particular, rotating handle 52 at positions M and N determines the bending angle of bendable body 12 at positions K and L, respectively. Rotating handle 52 can control the bending angle of multiple bending segments with multiple tap lines by using similar multiple bending segments.

[0061] More specifically, as the offset distance R of the drive wires 16 and 16' is increased to the offset distance S of the tap wires 26 and 26', the control angle of the rotary 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 distance R to the offset distance S. Furthermore, these ratios can be adjusted to allow more or less limited control of the bendable body 12, thereby further increasing the utility of the steerable medical device 10 of the present application.

[0062] By designing the tap unit 28 to increase the offset distance of the drive wires 16, the tap unit 28 can make sufficient circumferential spacing for the tap wires 26 when the circumferential spacing of the drive wires 16 in the bendable body 12 causes mechanical interference between adjacent tap wires 26, and can actuate a bendable body 12 with a smaller outer diameter. Thus, the bendable body 12 is able to reduce invasiveness in use, and allows for an expanded range of tools that can be inserted into the bendable body 12 due to the smaller diameter required for the bendable body 12.

[0063] Furthermore, the ability to disconnect the bendable body 12 and connect it to the tap unit 29 allows for independent sterilization of the various parts of the steerable medical device 10. Thus, the bendable body 12 can be easily and economically sterilized without the need to sterilize the actuator unit 36 and / or the tap unit 28. Also, the bendable body 12 can be disposable, while the actuator unit 36 and / or the tap unit 28 are reusable.

[0064] Furthermore, the tap unit 28 can be repeated in series, which can further increase the circumferential spacing in multiple stages to reduce frictional losses and deformation risks in the gaps.

[0065] Also, in conjunction with the rotary handle 52 as the actuator unit, the increased offset distance reduces the rotation angle of the rotary handle 52 to achieve a target bending angle of the bendable body 12. Thus, the user can achieve the target bending angle with a smaller operation stroke.

[0066] The rotary actuation handle 52 allows the operator to manually actuate the bendable body 12 by using a rotary motion in a plane corresponding to the bending plane of the bendable body 12, and the handle 52 can actuate multiple drive wires 16 with a simple small structure. When the bendable body 12 using multiple drive wires 16 produces multiple segments that bend along the center of mass, the handle 52 can be configured with series elements of independent rotary motion to control the individual bending of the multiple segments. Also, when the bendable body 12 with multiple drive wires 16 includes multiple degrees of bending in one bending segment, the handle 52 can be configured with multiple elements of rotary motion. Thus, the actuator unit 36 can be miniaturized, thereby making the steerable medical device 10 mobile and easy to configure and operate anywhere desired.

[0067] The rotary actuation handle 52 can be connected to the actuator and have the ability to disconnect and connect the entire structure between the bendable body 12 and the rotary actuation handle 52 from the actuator. In this embodiment, the drive wires 16 and tap wires 26 can be encapsulated and can be protected from damage caused by the external environment, such as mechanical impact, wear, moisture, caustic chemicals, etc.

[0068] In Figure 11 and Figure 12 Embodiments of the present disclosure provided as pictures have Figure 1 and Figure 2 similar construction of steerable medical devices in Figure 11 is a perspective view of a steerable medical device 10, Figure 12 is a top view of a bendable body 12 having six bend segments. The steerable medical device 10 in this embodiment includes a motor circuit 54 having multiple motors 34, a tractor 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 tractor 30. The six bend segments are implemented by six sets of drive wires and guide rings attached to the drive wires at staggered locations. Additionally, each of the six drive wires will require an actuator to facilitate independent bending of the medical device 10 by retraction or advancement of each drive wire.

[0069] Figure 13 Pictures of exemplary bendable bodies 12 are provided in accordance with one or more embodiments of the present subject matter. Figure 13 The bendable body 12 provided in is provided in two sizes. One example (“A”) has an outer diameter of 3.4 mm and guide rings having a pitch of 0.25 mm. Example A also includes a tool channel 44 having a diameter of 1.4 mm. A second example (“B”) has an outer diameter of 1.7 mm and a pitch of 0.2 mm for the guide rings. Both examples have struts made of a super-elastic titanium-nickel alloy. The struts are laser cut and include integral bend flexes at locations between adjacent guide rings so that the bendable body 12 can be bent in bend planes.

[0070] By incorporating multiple bend segments, the steerable medical device 10 can control the position of the tip of the bendable body 12 with a deeper reachable area and a wider selection of orientations. Also, by using multiple curvatures in the body 12, the bendable body 12 can reach a target through a complex path.

[0071] Figure 14A close-up view of the drive wire 16 attached to the tap wire 26 is shown. Here, a drive wire 16 with a diameter of 0.12 mm is attached to a tap wire 26 with a diameter of 0.35 mm. The drive wire 16 is inserted into the tap wire 26 and fixed with adhesive. Two helical springs 46 and 46' are located around the drive wire and prevent the drive wire 16 from deforming. In Figure 14 The outer spring 46 and the inner spring 46' have been partially detached in the image provided in the middle 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. It has been shown that a drive wire 16 with a length of 100 mm and a diameter of 0.12 mm delivers a target thrust (> 5 N) using this exemplary steerable medical device 10.

Claims

1. A medical device comprising: a bendable body having a first drive wire configured in the bendable body and a second drive wire configured in the bendable body independently of the first drive wire; an extension unit comprising: a first tap wire attached to the first drive wire; a second tap wire attached to the second drive wire; and a retraction guide surrounding the first drive wire along at least a portion of a longitudinal direction of the first drive wire, the retraction guide being movable relative to the first drive wire; and an actuator configured to retract and advance the first drive wire via the first tap wire and to retract and advance the second drive wire via the second tap wire, wherein the actuator is configured to steer the bendable body in at least two dimensions about a single axis point; wherein the retraction guide is movable along the longitudinal direction of the first drive wire, and wherein a diameter of the first tap wire is greater than a diameter 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 steering 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 unit for housing the first tap line and the second tap line, wherein, the tap unit includes guide tubes for guiding the first tap wire and the second tap wire, respectively.

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

7. The medical device of claim 1, further comprising a second retraction guide surrounding the second drive wire, wherein the second tap wire is in communication with the actuator.

8. The medical device of claim 1, wherein, the second drive wire is configured in a different location relative to the bendable body than the first drive wire.

9. The medical device of claim 1, wherein, the first tap wire is configured to push the retraction guide as the retraction guide retracts.

10. 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 and have a distance between them, each guide ring comprising at least one slit configured to accommodate at least the first drive wire or the second drive wire.

11. The medical device of claim 10, 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 helical direction than the first spring.

12. The medical device of claim 5, wherein, the tap unit is configured to increase an offset distance of the first drive wire and the second drive wire proximally of an actuator of the medical device.

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

14. A connector device comprising: at least a first drive wire and a second drive wire extending from the connector device and configured to drive a steerable device; an extension unit comprising: a first tap line attached to the first drive line; and a first retraction guide substantially surrounding the first drive line along at least a portion of a longitudinal direction of the first drive line, the first retraction guide being movable relative to the first drive line; a second tap line attached to the second drive line; and a second retraction guide substantially surrounding the second drive line along at least a portion of a longitudinal direction of the second drive line, the second retraction guide being movable relative to the second drive line independent of the first drive line; and an actuator configured to retract and advance the first and second drive lines via the first and second tap lines, respectively, and configured to steer the steerable device in at least two dimensions about a single axis point; wherein the first and second retraction guides are movable along the longitudinal direction of the first and second drive lines, respectively, and wherein a diameter of the first tap line is greater than a diameter of the first drive line.

15. The connector device of claim 14, further comprising: a first spring parallel to and surrounding the first drive line; and a third spring parallel to and surrounding the second drive line.

Images