The present invention relates to surgical tools for performing surgical operations. More specifically, the present invention relates to small diameter surgical tools for navigating the patient's anatomy in order to deliver therapy to a target location in the patient's body. In particular, the present invention relates to a surgical device with a bendable joint, such as a bendable tip that has an arc length varying curvature for implementation in small-diameter microsurgical tool devices, such as hand-operated catheter-like manipulators or concentric tube robots.
There is a pressing need in robotic or remotely controlled hand-operated surgery for small-diameter surgical tools with bendable tips, which are sometimes referred to as bendable tip 12 joints or bendable tips 12 because they act as the bending joint proximate to the tool at the distal end or tip much in the manner that the human bendable tip 12 serves in relation to the hand. Most existing small-diameter surgical tools devices do not include bendable tips 12 and thus cannot navigate the sharp corners encountered in surgery, such as those at the skull base, in the middle ear, and in the ankle. Moreover, dexterity driven tasks, such as tissue resection and suturing, can be difficult to perform without a bendable tip 12, especially through the small openings characteristic of natural orifice or percutaneous procedures.
In one particular surgical field, small-diameter bendable tips 12 are needed to augment the capabilities of microsurgical devices, such as small-diameter catheter-like or concentric tube surgical robots, which can have diameters on the needle-sized order (e.g., having diameters as small as 1.0 mm or less). The performance of these small-diameter robotic systems, which are devised for delicate and intricate surgical procedures such as pituitary tumor resection, neurosurgery, and intracardiac surgery, among others, can be significantly enhanced with the addition of small bendable tips 12 for aiding in manipulating their end-effectors.
Many small bendable tips 12 based on traditional mechanical linkages have been devised in the past. For example, previous small bendable tips 12 have been designed to incorporate the use of ball joints, universal joints, cable/pulley mechanisms, lead screws, parallel serial chains, and flexures. These designs range from 2.4 to 15.0 mm. Although it could be possible to downscale each of these designs to some degree, designs with a continuum structure, i.e., those in which are machined or otherwise engineered directly into the shaft structure of the catheter, needle, concentric tube, etc. would be easier to miniaturize than those containing multiple components. Among these continuum structures, those with the fewest components are most desirable for downscalability, making designs that involve machining the shaft of the device itself particularly appealing. Examples of continuum structures involve cutting nitinol tubes to create rectangular or triangular cutouts that form a compliant region for bending. In these instances, however, the diameters remain comparatively large, e.g., on the order of 6-10 mm.
Additionally, known bendable structures suffer from limitations that relate to the manner in which their bending takes place. An example of this is shown in
A small-diameter bendable tip allows a user to design a tip with arc length varying curvature. The user can select properties, such as which portion of the tip bends first, in which order subsequent portions bend, how far each section is able to bend, and the general motion of the bending). This design improves the performance of commercial bendable catheter tips and microsurgical devices by enabling the user to specify the motion of the bendable tip and enhancing the dexterity of the tip in small spaces during surgery, an important characteristic of small steerable surgical devices.
According to one aspect, the invention relates to a bendable joint including a tubular structure including a tubular side wall that extends along an axis and defines an inner lumen. At least one cutout is positioned along the length of the sidewall. Each cutout includes an axial portion of the sidewall that is removed and provides communication with the inner lumen. Each cutout helps to define a bend joint and at least one bend section. The bend joint includes the remaining portion of the side wall left along the length of the cutout. The at least one bend section includes complete tubular portions of the sidewall on opposite sides of the cutout. Each bend joint can deflect so that adjacent bend sections move relative to each other and assume a curved configuration.
According to another aspect, the bend sections associated with each bend joint an move toward each other in response to deflection of the bend joint.
According to another aspect, the bendable joint can include a tendon cable that extends within the inner lumen and has a connection with a distal one of the bend sections, Tension on the tendon cable can be applied to the distal one of the bend sections, which causes the bend joints proximal of the connection to deflect and causes the associated bend sections to move towards each other and assume a curved configuration.
According to another aspect, the cutouts can have geometries selected such that the physical properties of the bend joints differ from each other, which causes the curvature of the bend joint to vary along its length. The cutouts can have geometries selected such that the physical properties of the bend joints differ from each other, which causes the bend joints to deflect in a predetermined order in response to tension applied to the tendon cable.
According to another aspect, the tubular structure can be an inner tube of a concentric tube robot.
According to another aspect, the cutouts can have rectangular geometries. The cutouts can be aligned with each other along the axis of the tubular structure. The cutouts can be rotated relative to each other along the axis of the tubular structure.
According to another aspect, the geometries of the bend sections defined by the cutouts can be configured to define the amount of deflection that each bend joint can undergo. The geometries of the bend sections defined by the cutouts can be configured to collectively define the range of bending motion that can be achieved by the bendable joint.
According to another aspect, the cutouts can define the joint along a tip portion of the tubular structure.
According to another aspect, the tubular structure can be a nitinol tube.
According to another aspect, the tubular structure can include a needle structure. The terminal end portion of the tubular structure can include a needle tip comprising a sharpened point. A cutout can be positioned adjacent to the needle tip. The bend joint defined by the cutout can allow the tip to deflect relative to the remainder of the tubular structure. The needle tip can include a beveled lead surface that is angled relative to a longitudinal axis of the tubular structure. The lead surface can be configured such that when the needle tip is advanced longitudinally through tissue, the tissue acting on the lead surface urges the needle tip to deflect relative to the remainder of the tubular structure through bending of the bend joint.
According to another aspect, the bendable joint can include a tendon cable that extends within the inner lumen and has a connection with the needle tip. Tension on the tendon cable can be applied to the needle tip, which causes the bend joint adjacent the needle tip to deflect. Deflection of the needle tip relative to the remainder of the tubular structure can cause the tubular structure to follow a curved path when advanced through tissue.
According to another aspect, the bendable joint can include an end effector for performing a surgical function positioned at the distal end of the tubular structure distal of the bend joint. A tendon cable can extends through the tubular structure and be connected to the end effector. The tendon cable can be actuatable to cause actuation of the end effector.
According to another aspect, the cutouts can have non-rectangular geometries. The cutouts can have geometries that are generally key-shaped when viewed in profile. The key-shaped cutout geometries result in the bend sections having a generally tapered configuration, and the bend joints having semicircular edge portions. Adjusting the geometry of a circular portion of the key-shaped cutouts can affect the force required to deflect the bend joints. Adjusting the spacing and angle of tapered edges of the cutouts can affect the range of motion permitted between adjacent bend sections.
The present invention relates to a surgical device with a bendable tip that has an arc length varying curvature for implementation in small-diameter surgical tool devices. Referring to
As shown in
In the example embodiment, there are two concentric tubes: a straight, typically stainless steel, outer tube 22 and a curved, typically nitinol, inner tube 24. The outer tube 22 and inner tube 24 are individually and independently movable both axially along and rotationally about a longitudinal axis 28. In the retracted position illustrated in
Referring to
The surgical tool 10 can deliver the surgical instrument 30 to any location within the work space of the concentric tube robot 20. The surgical instrument 30 itself can be further manipulated, for example, via a flexible rod or cable 32 that extends through inner lumens of the concentric tubes 22, 24. The cable 32 can be manipulable, for example, to cause rotation (arrow B in
The small-diameter bendable tip 12 is positioned at the distal end of the inner tube 24 just proximal of the instrument 30 and thereby connects the surgical instrument 30 to the concentric tube robot 20. Conveniently, in the example embodiment of
Actuation of the bendable tip 12 is effectuated through the actuation of a tendon cable 40 which extends through the inner lumen of the concentric tubes 22, 24 and is connected to the bendable tip. A motor or other suitable drive mechanism (not shown) applies and varies the tension on the tendon cable 40 in order to effectuate the desired degree of bend in the tip. The drive mechanism for the tendon cable 40 can be integrated into the drive unit that operates the concentric tube robot 20 and the surgical instrument 30. Actuation of the concentric tube robot 20, surgical instrument 30, and bendable tip 12 can thus be controlled via a single controller or control system that integrates and coordinates the control of all of these devices.
Referring to
As shown in
In the example of
Examples of different geometries for the cutouts 50 are illustrated in
The pattern of the cutouts 50 could be arranged in patterns that differ from the straight line pattern in the example embodiment of
According to the invention, the construction of the bendable tip 12 allows the tip to be designed with an arc length varying curvature that is customizable to meet the demands of the user. By “arc length varying curvature,” it is meant that the properties or characteristics of under which each bend joint 52 and bend section 54 act during bending of the tip 12 can be configured individually. For each bend joint 52 and bend section 54, the geometry of the cutout 50 can be configured to allow a user to select bend characteristics, such as the amount of force required to deflect each bend joint 52, the order in which each bend joint/section of the tip bends, the range of deflection for each bend joint/section, and the general motion, i.e., straight vs. curved/helical, of the bending. The design of the bendable tip 12 offers improved performance by enabling the user to specify the motion of the bendable tip and enhancing the dexterity of the tip in small spaces during surgery.
Viewing
Referring to
Referring to
The arc length varying curvature of the bendable tip 12 is customizable through selection of the geometry of the cutouts 50, which define the geometries of the bend joints 52 and bend sections 54. Each cutout 50 can have a uniquely configured geometry that defines the amount of force required to deflect the bend joint 52, the direction in which the joint deflects, and the geometry of the bend sections 54, which define the limit of angular deflection. In this manner, the behavior of each segment of the tip 12, i.e., the bend joint 52 and adjacent bend sections 54 defined by a cutout 50, can be tailored so that the motion profile of the tip, and the attached surgical instrument 30, is suited to perform the desired tasks. The tip 12, so designed, can access the target anatomical structures while avoiding others.
The bendable tip could have additional configurations that lend to its ability to provide a desired degree of reach and dexterity. For example, referring to
In Configuration A in
Configuration B in
Referring to
Referring to
Device Modeling
To design the bendable tip 12 that exhibits an arc length varying curvature tailored to specific anatomical target structures and workspaces, kinematics and statics models are required. The kinematic model predicts the operation or motion of the bendable tip 12. The statics model predicts how forces acting on the bendable tip 12, i.e., the forces applied by the tendon cable 40, affect the bending of the bend joints 52 and sections 54.
Referring to
One potential limitation of an asymmetric design is that it can bend in only one direction in the plane, rather than two. However, provided axial rotation of the entire device is possible (which it typically is for such devices), the impact of any potential drawback is minimized. Another potential limitation of an asymmetric bendable tip 12 is that while it can readily apply pulling forces, it can only apply pushing forces if the tissue being pushed is more compliant than the bendable tip 12 itself. It can, however, be possible to stiffen the bendable tip 12 to assist with pushing by inserting a wire through the central lumen.
In addition to being able to be manufactured and assembled at small diameters, the continuum cutout design also offers a large design space. In the kinematics and statics modeling, the cutouts 50 are restricted to rectangular cutouts because they are straightforward to machine. With this restriction, the design parameters available are the height, depth, and spacing between cutouts 50, as well as the number of cutouts. The models and design principles set forth below allow the designer to use these parameters to select the device's overall radius of curvature, total maximum bend angle, and required tendon force for actuation.
We begin by modeling the kinematics of a single cutout of the asymmetric continuum bendable tip 12. We assume that the portion of the tube that undergoes bending deforms in a constant curvature arc. This is a good assumption for small cut heights h, because the tendon follows an approximately circular path in this case. Following the direction of R. J. Webster III and B. A. Jones, “Design and kinematic modeling of constant curvature continuum robots: a review,” The International Journal of Robotics Research, vol. 29, no. 13, pp. 1661-1683, 2010, we map tendon displacement (actuator space) to arc parameters (configuration space) then map arc parameters to task space.
Arc parameters and relevant kinematic values for single cutout are shown in
The location of the neutral bending plane is dependent on the depth of cut g and the inner and outer radii of the tube (ri and ro shown in
where Ao and Ai are the areas defined in
which are valid for cuts that are at least as deep as the outer radius of the tube.
Now we can use
Since we want the mapping of tendon displacement to curvature, we need to invert (3). Since it has no analytic inverse, numerical techniques can be used, or, for small angles, we can use a first-order approximation to yield:
Once κ is known, s can be found using:
Once the arc parameters κ and s are known, the homogeneous transformation between frames j and j+1 (as defined in
Due to the rectangular cutout geometry of the bendable tip 12, the kinematic transformation from the base of the bendable tip 12 to the tip can be obtained. The kinematics of the entire bendable tip 12 are given by repeatedly applying the transformation (6) in conjunction with translations to account for the portions of the bendable tip 12 that do not bend:
where n is the number of cutouts and Tz-a, Tz,b-c, and Tz,c are translations along the z-axis by a, b-c, and c, respectively, as defined in
And thus the maximum angle of rotation for a single cutout is given by:
Two important bendable tip 12 characteristics, maximum bending angle and minimum radius of curvature, as shown in
where the approximately circular arc that defines ρmin has length:
Modeling the static behavior of the bendable tip 12 is more challenging than modeling the kinematic behavior, yet with the assumption of constant curvature bending, it is tractable. Based on the constant curvature assumption, strain along the length of the bendable tip 12 varies in a cross section of the portion of the tube in bending according to:
and thus is linearly distributed about the neutral bending plane. This assumed relationship between the geometry and the material deformation allows for a simple computation of the strain energy, after which we use Castigliano's first theorem to determine the reaction force at the tendon. In general, the behavior of nitinol under applied stresses is complex and highly nonlinear, and depends on thermomechanical history. In this work we assume a simplified material model that represents the stress-strain behavior of nitinol as a piecewise linear stress-strain curve, so that the stress may be written as a function of strain as:
where σlp is the lower plateau stress (corresponding to compression), σup is the upper plateau stress (corresponding to tension), and E is Young's modulus. Since we are modeling the material deformation as a one-dimensional stretching and compression of axial fibers, the strain energy density is the area under the stress-strain curve, given by the integral:
W(∈)=∫0∈σ(e)de (Eq. 15)
The total strain energy stored in the bendable tip 12 as a function of the curvature κ of a single cutout is given by:
U(κ)=n∫V
where Vc is the volume defined by the “Top View Cut” cross section of
where L is the moment arm length and θ=nsK. When the tendon is looped around the top flexure as shown in
Due to friction, the force the tendon applies to the tip of the bendable tip 12 will be a fraction of the actuator force applied to the tendon. Friction between the tendon and the tube wall becomes increasingly significant as cut height and angle of bending increase. To model this effect, we first find the angle γ (shown in
where η<1 accounts for the force lost due to friction at a corner. We can substitute (18) into (17) to yield:
where 2n is included to account for the two corners of each cutout. This expression can be evaluated numerically using a finite difference method to relate Ftendon and θ. This statics model is experimentally validated in the following paragraphs.
A prototype of the bendable tip 12 is shown in
The prototype bendable tip 12 was built using a MicroProto Systems MicroMill 2000 CNC mill (a small tabletop CNC mill) with aluminum titanium nitride coated, two flute, carbide, long flute, 0.02″ diameter square end mills. The tube was fixtured by gluing it in a channel drilled in an aluminum block. The nitinol tube had an outer diameter 1.16 mm and inner diameter of 0.86 mm. A cut depth of g=0.97 mm was chosen, which corresponds to a required tendon force for full bending of Ftendon=5N and a maximum outer-fiber strain of 10.4% (Note that this is slightly higher than the 8-10% recoverable strain typically quoted for nitinol, but that it has been found to work well in practice, since only a small amount of the material at the very outside edge of the bendable tip 12 undergoes this strain, and then only at maximum articulation). The cut height was h=0.51 mm. The spacing between cuts was c=0:51 mm. The number of cuts was n=5 cuts in order to achieve greater than 90 degrees of bending. A summary of the design parameters and resulting design characteristics is shown in Table I:
An experiment was conducted to validate the kinematic relationship of Equation 7 and the static relationship of Equation 19 concurrently. The experimental setup included a linear slide (Velmex A2512Q2-S2.5) with 0.01 mm resolution to displace the tendon and a force sensor (ATI Nano 17) with 3.125 mN resolution to record tendon force. The tendon was rigidly fixed to an acrylic plate that was then mounted onto the force sensor. The tendon and sensor assembly were then rigidly fixed to the linear slide carrier.
The nitinol tube with cutout bendable tip 12 was mounted into a test fixture that was rigidly mounted to an optical table, such that the tube remained stationary while the bendable tip 12 was deflected with the linear slide. A 1 mm resolution grid was placed below the bendable tip 12, and a camera mounted directly above the bendable tip 12 was used to capture images of the bendable tip 12 as it deflected. The bendable tip 12 was deflected in tendon displacements of 0.2 mm, and a picture of the bendable tip 12 deflection and the tendon force were recorded at each increment.
Using image processing, the tip position was determined for each incremental deflection of the tendon. At full articulation, it was observed that the distal cutout was held open by the tendon that was routed through it (see
Referring to
An experimental validation of the statics model is shown in
The prototype represents one set of viable design choices. With the rectangular cut profile described in previous sections, the designer must choose the depth of cut g (see
Cut height is not as significant as cut depth in determining bendable tip 12 behavior, but it is a factor in the bending radius (Eq. 10 and 11). Moreover, if cut height becomes too large, the constant curvature assumption will no longer hold, risk of buckling-like failure will increase, and frictional losses will increase (Eq. 18 and 19).
The portions of uncut tube between the cutouts serve as hard stops which limit strain, allow large forces to be applied in the bendable tip's fully deflected state, and route the tendon in a curve that approximates a circular arc. The height of the uncut portions, parameter c in
Additionally, if uniform curvature in multiple cutout sections is desired, it is essential to use a highly repeatable cutting process, as slightly deeper cutouts deflect much further for a given force than shallower cutouts do. That being said, it may be advantageous in future work to take advantage of non-uniform cut depths (and/or heights) to compensate for factors like non-constant tendon tension (due to frictional losses) along the bendable tip 12, or application-specific design objectives.
The experimental results show that the constant curvature assumption is a reasonable, though not perfect, approximation for our bendable tip 12. We believe that tendon elongation was the primary source of error in the kinematics, which resulted in the model and experimental tip points not aligning perfectly in
In the future, we plan to study the significance of hysteresis in our statics model and develop a three-dimensional stiffness model in order to characterize the forces that the bendable tip 12 can exert. We also plan to conduct finite element modeling to characterize torsional properties and fatigue life and to explore strain profiles of non-rectangular cutouts. Another area of future work is to explore non-square cutout geometries to optimize bendable tip 12 performance for specific tasks.
Another embodiment employing the same principles described above is illustrated in
The cutout 114 defines the boundary between an elongated body portion 120 and a tip 122 of the steerable needle 110. The body portion 120 can have any desired length, which can, for example, vary depending on the procedure in which the steerable needle 110 is implemented. The tip 122 is formed by a beveled cut of the tube 112 that is filled or closed off, for example, by welding, soldering, or brazing, to form an angled or beveled lead surface 124. Alternative fillers, such as a polymer, can be used to fill the tip 122 and form the lead surface 124.
The cutout 114 extends into the tube 112 in a direction normal to the tube axis 130, entering the tube from opposite the lead surface 124. In the embodiment illustrated in
The elongated tubular configuration of the bendable tip needle 110 advantageously includes a long inner lumen that defines a channel 126 within the body portion 120 of the tube 112 that extends to the opening, i.e., the cutout 114, adjacent the needle tip 122. This channel 126 can serve as a large working channel from the base of the needle to the tip, for example, to perform biopsy or drug delivery therapies. Further facilitating this is the fact that the bend is facilitated by the cutout 114 in the tube 112, which eliminates the need for any mechanical joint components that would consume space in the channel 126.
Referring to
Referring to
Referring to
Referring to
In the configuration of
The bendable tip steerable needle 110 is suited for any needle-based procedure that requires accurate targeting and also provides the ability to reposition/retarget without full removal of the needle. This feature can be particularly useful, for example, for correcting needle misalignment or unforeseen deflection of the needle during insertion.
The design of the bendable tip steerable needle 110 is straightforward and simple to build from a manufacturing perspective, while advantageously leaving the center working channel open all the way to the tip of the needle. Tip deflection can be achieved in a simple, accurate, and repeatable manner through tension on the tendon cable 140. Though simple in design, the steerable needle 110 can exhibit a high degree of steerability with minimized tissue damage and a high degree of curvature.
This application is a divisional of U.S. patent application Ser. No. 15/164,257, filed May 25, 2016, which claims the benefit of U.S. Provisional Application Ser. No. 62/166,310, filed May 26, 2015, and U.S. Provisional Application Ser. No. 62/296,620, filed Feb. 18, 2016. The subject matter of these applications is hereby incorporated by reference in its entirety.
This work was funded in part by the National Science Foundation (NSF) under CAREER award U.S. Pat. No. 1,054,331 and three Graduate Research Fellowships. It was also funded in part by the National Institutes of Health (NIH) under award numbers R01 EB017467 and R21 EB017952. The U.S. Government may have certain rights to the invention.
Number | Date | Country | |
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62166310 | May 2015 | US | |
62296620 | Feb 2016 | US |
Number | Date | Country | |
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Parent | 15164257 | May 2016 | US |
Child | 16176068 | US |