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Telerobot for Needle Distal Tip Steering


Conor James Walsh, Jeremy Franklin, Alexander H. Slocum, Julio Guerrero, Rajiv Gupta

[1]. Initially providing only palliative care, Radio Frequency


Abstract – This paper focuses on the design and development of Ablation (RFA) is now used for complete eradication of
a telerobot for needle distal tip steering. Current image-guided tumors in a variety of organs (e.g. lung, liver and kidney).
procedures are operated manually and limited by targeting errors Another rapidly growing area of treatment is brachytherapy
due to instrument misalignment, deflection and an inability to
reposition the distal tip of the instrument after it has been
where small radioactive seeds are deployed through a needle
inserted into the skin. These limitations result in suboptimal and implanted into the tumor. There are also a growing number
diagnosis and treatment for patients as well as excessive of other procedures where material is injected to a targeted
procedure times and radiation dose from medical imaging. To location in the body for structural or therapeutic purposes.
address this we are developing a telerobot capable of distal tip Typically the procedures are performed under image-guidance
steering based on the concept of deploying a flexible pre-curved such as computed tomography (CT), fluoroscopy, ultrasound
stylet from a concentric straight cannula. Analytical models were
developed to understand what material properties are required to
and magnetic resonance imaging (MRI) that provide high
recover from the imposed strains and calculate the deployment resolution images of the patient anatomy. After a target is
and retraction forces required for moving the stylet relative to the identified in the body a needle insertion point is chosen so as
cannula and were compared to experiments. The curved stylet to avoid obstructing structures (such as ribs and blood vessels)
was modeled as a curved beam on an elastic foundation in order and the needle is then manually inserted towards the target.
to estimate its end-point defection when subject to a tangential
cutting force. The analysis and experimental results were then A. Technical Difficulty
used as design specifications for a telerobotic system that is Physicians currently find it challenging to precisely place
capable of implementing the desired relative motions for the
needles to the desired target due to the difficulty in manually
cannula and stylet so that a volume may be targeted by the distal
tip of the stylet inside the body. The prototype system is designed
aligning the needle along the desired trajectory, needle
to be made from largely plastic components and actuation is movement due to tissue tension, respiratory motion and limited
achieved using micro stepper motors. The proximal end of the supporting subcutaneous soft tissue to support the instrument.
cannula is attached to the distal end of a screw-spline that enables Further unwanted buckling of the needle as it is being inserted
it to be translated and rotated with respect to the casing. may result in the instrument taking a curved shape and thus
Translation of the stylet relative to the cannula is achieved with a deviating from the desired trajectory as it is inserted into the
second threaded screw with a splined groove. The desired position tissue. The needles are often quite long (10-20 cm) and
of the distal tip is specified using a custom interface. A detailed inserted into a patient’s body and can exhibit significant
evaluation of the system in ballistics gelatin is planned. deflection that causes it to deviate from its desired trajectory.
The subsequent small angular errors result in large lateral
Index Terms—needle, steering, screw-spline, telerobot.
displacements of the distal needle tip because the pivot point is
at the skin surface. It is a summation of errors that results in
I. INTRODUCTION
the inability of the radiologist to place the distal tip of the

M inimally invasive percutaneous procedures are routinely


performed procedures for both the treatment and
diagnosis of disease. In medicine, percutaneous needle
needle to the desired target within even an order of magnitude
of the sub-millimeter and sub-degree measurements from the
CT display. Figure 1 illustrates how alignment errors and
insertion pertains to any medical procedure where the skin is needle bending result in the needle not hitting the desired
punctured with a rigid needle to access to inner organs or other target.
tissue as opposed to an approach where surgery is performed Reorientation of the needle once inside the body is difficult,
to expose the inner organs or tissue. A biopsy involves the if not impossible, as there are forces from the tissue that resist
removal of cells or tissues for histological or chemical the pivoting motion. Thus in order to reposition the distal tip of
examination. The removed cells or tissue are generally the needle once it is inside the body the radiologist has two
examined under a microscope by a pathologist. An options, they can try and overcompensate when realigning the
increasingly significant portion of percutaneous procedures are needle or they can retract the needle and attempt to re-insert it
for the local treatment of disease in a minimally invasive along the correct trajectory. However, both of these
manner. Tumor ablation is defined as the direct application of approaches result in damage to the tissue that can be
chemical or thermal therapies to a specific focal tumor (or uncomfortable for the patient and lead to a variety of
tumors) to achieve eradication or substantial tumor destruction complications. Further, if the instrument is assumed to pivot
about the skin surface it is difficult for the radiologist to
predict movement of the distal tip of the needle inside the body
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and any excess manipulation can lead to tissue damage and of the medical instrument while it is inside the body. For
complications. biopsy, an increased targeting capability and an ability to
accurately target multiple locations within a single lesion
would allow for higher diagnostic rates as well as a reduction
in the procedure time and radiation dose for the patient. As
well as correcting for targeting errors due to instrument
deflection or tissue deformation, there is also room for a
radical departure from the current methodology for local
treatments such as radiofrequency ablation. Instead of a large
diameter probe, or a probe with multiple electrodes, a very thin
probe with a small burn volume could be inserted into the
tumor and then robotically steered so as to raster-scan through
the tumor after a single needle insertion through the skin. Such
a system would enable treatment to be applied to multiple
small but overlapping volumes allowing conformation to the
Figure 1 - Sources of targeting errors in image-guided, percutaneous tumor morphology, while avoiding important collateral
interventions
structure. Finer treatment margins as well as the ability to treat
multiple tumors, satellite lesions or tumors that cannot be
B. Clinical Consequences
accessed along a straight path are clear advantages of such an
Due to this difficulty in precisely placing needles and approach.
repositioning of their distal tip when inside the body,
radiologists currently find it difficult to target lesions that are II. PREVIOUS WORK
less that 10 mm in diameter and target multiple points of
lesions. This results in a delay to diagnose cancer when the Various robotic and navigation systems have been developed
tumor size is small and apply precise local treatment to all to increase the accuracy of percutaneous needle placement.
points of a tumor while avoiding the surrounding anatomy. If a These systems generally consist of robots that mount on the
biopsy is required for diagnosis, often a patient is forced to CT scanner bed [2-4] or the patient [5-7] and provide some
wait for 3-6 months until the tumor is large enough so that it method for remote needle orientation and insertion. The
can be targeted. Some experienced physicians do choose to majority of these manipulators provide a remote center of
target smaller lesions but to achieve this, a large number of rotation so that the needle can pivot about the skin surface [8-
manipulations of the needle are required that results in 10]. All of these systems use some combination of intra-
increased tissue trauma, complication rates, x-ray dose and operative CT images [2], pre-operative 3D imaging [2], static
procedure times. While there are clear benefits to locally real-time fluoroscopy [2, 11] or tracking systems [12-14] for
treating disease the number of procedures that can be procedure planning and execution. The doctor typically
performed in this way is limited. For example, current RFA controls them via joystick [2, 11] or a point and click interface
probes only provide a static volume of coagulative necrosis. that directly incorporates the medical images [3, 6]. In all cases
The probe is deployed at a single location to achieve a pre- some registration between the patient, robot and imaging
determined (typically cylindrical, spherical or ellipsoidal) burn coordinate systems is required. This can be performed
volume that includes the tumor. Due to the difficulty in placing automatically or semi-automatically with fiducial markers
the instrument precisely, often the physician is forced to take placed on the tools and patient [3, 5, 13-16] and in some cases
unnecessarily large treatment margins so as to avoid leaving these fiducial markers are tracked so as to provide motion
part of the tumor intact. To generate large ablation volumes RF compensation.
ablation systems have been developed that have three or more Although robotic systems have demonstrated the ability to
electrodes in parallel attached to a single probe handle. improve the accuracy of needle placement, no telerobotic
However it is difficult to keep all electrodes correctly spaced system has the capability to reposition the distal tip of the
relative to each other and these systems often cause the tissue needle after the needle has been inserted through the skin and
or tumor to be pushed out of the way as opposed to punctured. into the body. As mentioned previously, this may be used to
Another approach to achieve a larger burn volume with a correct for targeting errors due to instrument deflection or
single needle insertion through the skin is to have an umbrella tissue deformation as well as target multiple points of a tumor
like flock of electrodes deploy from the distal tip of the needle. for more effective diagnosis and treatment.
To generate even larger or irregularly shaped ablation volumes Research is ongoing to develop needle insertion strategies to
multiple skin punctures are made with multiple probes to insert minimize deviation of the needle from its desired path.
electrodes into different locations of the tumor so as to burn Spinning of the needle as it is being inserted has been shown to
the entire extend of the tumor. reduce deflection [17]; however continuous spinning of a
beveled needle may lead to tearing of tissue, resulting in
C. Need for Needle Distal Tip Steering increased trauma for the patient. Another approach that has
In order to correct for these errors or to position the distal tip been used by physicians is to rotate the needle by 180˚ a
of the needle at multiple points within the body through a number of times during insertion causing the needle bevel to
single skin puncture, it is desirable to reposition the distal tip point in the opposite direction. This approach has been
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automated with a robotic system where the amount of needle creating a straighter trajectory. A kinematic model for needle
deflection was estimated using a model based approach from steering using this method is presented in [22] and is based off
real-time force and moment data at the needle base (where it is the nonholonomic model for bevel needle steering presented in
gripped by the robotic manipulator) and the insertion depth [20]. However, as mentioned earlier needle spinning will result
[17]. The system worked by automatically rotating the needle in damage to tissue, only thin needles can be used and the
180˚ when the bending moment on the needle exceeded a same difficulties exist in finding the values of the model for
predefined threshold before inserting it further. controlling the motion. Salcudean et al. developed a device
An extension of minimizing needle deflection is that of that enables multiple needle curvatures to be achieved by
needle steering. Currently, physicians attempt to steer standard employing a stylet that is longer than the cannula so that up to
needles by bending the part of the needle that is partially or 2 cm of the stylet tip (with a mild curve) can be selectively
fully outside the body so that it takes a curved trajectory when exposed [23, 24]. The extended curve essentially acts as an
inserted. They also exploit the asymmetric bevel tip to cause adjustable bevel on the tip of the needle. Motors provide
the needle to “glide” to one side. These approaches do allow actuation for the rotation and extension of the stylet with
some needles to be steered; however, they are not very respect to the cannula. The steering direction is selected by
intuitive for radiologists and require reaction forces from the rotating the stylet and the steering rate is selected by extending
tissue; so controlling the needle motion is difficult. Mathis and the stylet and exposing the curve. By withdrawing the stylet,
Yankelevitz et al. developed a steerable needle that enables the the stiffer cannula straightens out the curve and the needle
radiologist to exert a curved shape on the needle [18]. The becomes approximately straight. A miniature two-axis analog
mechanism consists of a pivoting handle on the proximal end joystick is mounted on the shaft of the device facing opposite
of the needle that is attached to its distal tip via four small steel the insertion direction so that the physician can firmly hold the
bands. The radiologist can cause the needle to take a curved device in his or their palm and manipulate the joystick with the
shape by manipulating the handle or joystick with his/her thumb. This system also requires a thin flexible needle whose
thumb. However, this device lacks accurate controllability; in complete shaft can bend due to reaction forces from tissues and
particular, when it is already partially inserted into the body. “follow” the steering tip.
Further, there is no locking mechanism to hold a particular It is clear that there are limitations with the needle steering
curvature. strategies that have been employed to date; in particular,
Various research groups are actively working on automating relying on knowledge of the material properties has obvious
needle steering in order to improve its accuracy and limitations. Material properties are inhomogeneous, vary with
controllability. The approaches that have been taken use bevel patients as well as across tissue layers. While these strategies
[19-21] and external [19] forces on the needle to cause it to offer the potential for steering around anatomic structures, a
bend so as to steer through the tissue. In [19], DiMaio and major limitation is that once the needle tip is placed at the
Salcudean formulated a needle Jacobian that described tip desired point, it cannot be easily repositioned to a near by
motion due to needle base motion and a tissue finite element point. Instead of steering the entire needle length, another
model. They assumed that the needle was rigid compared to approach is to insert the needle along a straight trajectory
the tissue and that it was redirected by pulling on and angling (ideally) and then have a mechanism for repositioning the
the needle shaft outside the body. Although they demonstrated distal tip of the needle. Such a mechanism would be useful for
the ability to steer the needle, this approach involves the targeting multiple points in a volume or for directing the
knowledge of the tissue material properties. Further, the large needle tip around obstacles when a straight line trajectory can
forces may result in tearing and significant damage to the not be taken.
tissue. Webster et al. considered a system where the needle Two passive devices exist that accomplish this via an inner
was flexible relative to the tissue and thus does not displace a cannula made from a superelastic material with a preformed
large amount of tissue in order to steer itself [20]. For this bend on the distal end that can be substantially straightened
system, needle steering resulted from the asymmetric forces on when retracted into a stiffer coaxial outer cannula [25, 26].
the needle tip due to the bevel. They developed a variant of the Needles based on these designs are now commercially
three-degree-of-freedom nonholonomic bicycle model for available with the main application being for spinal based
steering needles with bevel tips. However, this approach also procedures such as vertebroplasty. Using these devices,
required knowledge of the material properties and involved materials (e.g. bone cement or ethalol) can be injected at
fitting model parameters using experimental data from various multiples locations in a volume by rotating the inner needle
tracked needle insertions into a phantom with homogenous about and inserting it along its axis. The needle can also be
material properties. This approach is unsatisfactory as multiple “steered” around obstacles; although only the distal portion so
needle insertions would not be permitted clinically. Further, a there are limitations as to how much steering can be achieved.
large beveled tip and a small diameter needle are required to Despite the commercialization of products based on the
achieve a large working volume so this method is not suitable concept of deploying a flexible pre-curved stylet from a
for larger diameter instruments. concentric straight cannula, no analytical or empirical data
A similar system is presented in [21]. The system inserts the exist to guide the design of new medical products. Further, the
needle and applies “duty cycling” to the rotation, i.e. rotating current systems require manual operation and the do not lend
the needle in a spin-stop-spin-stop manner such that the bevel themselves to accurately targeting points in a volume. The
stops in the same orientation each time with longer stop work in this paper addresses these limitations through the
intervals creating steeper curvature and longer spin intervals characterization of a needle steering system based on the
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concept of deploying a curved stylet from a straight cannula stress, austenitic Nitinol is induced into a deformed martensitic
and development of a telerobot capable of the relative motions crystal structure, allowing it to elongate with relatively
required to position the distal tip of the stylet within multiple constant stress applied to it. Nitinol is not stable at this
points in a target volume after a single needle insertion through temperature in its martensitic state, and will revert to austenite
the skin. when the stress is relieved.
A subset of stylet geometries (diameters ranging from 0.5 –
III. DESIGN CONSIDERATIONS 1.0 mm and radii ranging from 10 – 40 mm) were chosen that
In order to develop a needle steering system based on the would fit inside standard medical needle cannula ranging from
concept of straightening a curved needle inside a stiffer outer 20 to 14 gauge. Based on these specifications the maximum
strain for these ranges was calculated and is plotted in Figure
cannula it is necessary to understand how effectively a needle
3.
can be straightened, what materials and geometry can he used
so that the material does not yield, what force/energy is
necessary to straighten the curved needle and how the curved
segment of the needle will deflect when it encounters forces
during cutting or other operations. Figure 2 illustrates the
concept of straightening a pre-curved flexible stylet inside a
stiffer, concentric outer cannula. Upon deployment of the stylet
from the distal tip of the cannula, the stylet will then take its
preformed shape.

Figure 3 – Predicted Wire Strain for Pre-Bent Wire Drawn into


Straight Cannula

It can be seen that for all cases the yield strain of stainless steel
(0.2%) is exceeded, while Nitinol’s superelastic properties
enable it to meet the requirements for the design specifications
identified.
B. Force/Energy to Straighten the Curve
Figure 2 – Pre-curved flexible stylet and rigid outer cannula
If we assume that the curved beam is straightened by pulling it
inside a rigid outer cannula then given that there will be some
A. Material and Geometry Considerations
clearance between the outer diameter of the stylet and the inner
From Figure 2 it is apparent that in being straightened the diameter of the cannula then we can assume that the shape the
curved portion of the stylet will undergo significant strains. stylet will take is shown in Figure 4 below.
These strains will depend of the radius of curvature and will be
assumed to vary linearly along the cross section of the stylet, a
reasonable assumption when the end radius is significantly
larger than the diameter of the wire. The longitudinal strains in
the stylet are inversely proportional to the radius of curvature
and vary linearly with the distance y from the neutral axis
y
εx = − (1) Figure 4 – Model of stylet behaviour when stylet is fully retracted
ρ
into cannula
The maximum strain will be located at the maximum
distance from the stylet cross section. A review of medical Cantilever Beam Model
procedures and physicians provided specifications on the stylet A simple cantilever beam model can be used to estimate the
geometry and material properties. Nitinol and stainless steel force required to straighten the stylet. The geometry of the
were selected due to their biocompatibility and pre-existing use curved stylet of radius, R, is shown in Figure 5.
in the manufacture of needles for percutaneous interventions.
Nitinol exhibits two material properties depending on its alloy,
superelasticity and shape memory, which are used extensively
in medical devices. Superelastic Nitinol can withstand strains
of up to 6-10% with little to no yielding in conditions around
the alloy’s Active Austenite Finishing Temperature. At high
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where k has a value of 1.1 when the bend radius is significantly


larger than the wire diameter. The expression can be
rearranged to give RSE as a function of R.
REk
RSE = (3)
(σ se + Ek )
For a given strain in the stylet, the location of the neutral axis,
R, can be calculated using the principle of static equilibrium,
and assuming that the stresses due to bending dominate. Thus
the net axial force in the wire can be equated to zero yielding
RSE 2 2
⎛d ⎞ ⎛ d⎞
Figure 5 – Curved beam geometry ∫ρ σ SE 2 ⎜ ⎟ + ⎜ y − ρ − ⎟ dy +...
⎝2⎠ ⎝ 2⎠
(4)
RSE 2 2
The maximum strain analysis results illustrated in Figure 3 2 Ek ( R − y ) ⎛ d ⎞ ⎛ d⎞
show that for almost all geometries the Nitinol will surpass its ... ∫ρ y ⎜ ⎟
⎝2⎠ ⎝
+ ⎜ y − ρ − ⎟ dy = 0
2⎠
transition strain (estimated to be 0.7%) and enter the
superelastic zone. From the manufacturers data sheets (Fort Finding Effective Stiffness
Wayne Metals Inc.), the young’s modulus before the With values for R, composite beam bending theory is applied
transitions strain was estimated as 75 GPa and the assumption to find an effective stiffness, EIeff, for a beam that has a
was made that the loading plateau stress, σSE, remains constant partially elastic, partially plastic (superelastic) stress
at 517 MPa for the entire plateau up until a yield strain of 6%. distribution. Modeling the elastic region of the wire with
The consequence of this is that as the stylet is straightened, Young’s Modulus E (75GPa), and the plastic (superelastic)
there will be an increasing component of the cross section in region with a Young’s modulus of zero, EIeff can be obtained
the superelastic stress-strain region as illustrated in Figure 6. from
The radius of curvature of the stylet is ρ. As the stylet goes d
from straight to curved, the cross section will have an 2
⎛d⎞
2
advancing superelastic front that will reach its maximum area
when the stylet is fully inside the cannula. Thus, the stylet can
EI eff =
d
∫ 2 Ey 2 ⎜ ⎟ − y 2 dy
⎝2⎠
(5)
− + ( RSE − ρ )
be treated as a composite beam with ASE loaded with a constant 2

stress of 520MPa, and areas A1 and A2 undergoing elastic In equation (5) the effective stiffness at the structure’s
deformation. maximum strain state is evaluated, i.e. for a straight beam bent
to the initial radius of curvature of the stylet. It should be noted
d that for a few cases, the maximum strain in the wire was
calculated to be less than the 0.7% transition strain of Nitinol
Superelastic Zone and so the beam was consider as purely elastic and equation
(5) was not used.
Neutral Axis
Energy Analysis
Assuming elastic deformation, the energy contained within a
curved beam shown in Figure 5 is
π
2
1 M 2ρ
U=
2 ∫
0
EI
dθ (6)
RSE R ρ
The curved cantilever shown in Figure 5 will have a moment
that varies along its length because it is subjected to the
tangential force, F. Thus, the radius of curvature will also vary
Y along its length. For an elastic-perfectly plastic (superelastic)
Center of
Curvature beam, however, EIeff is dependent on the bend radius as shown
in equation (5). Thus, EIeff is based on geometric and material
Z
properties that are not considered in this model. For the
Figure 6 – Cross Sectional view of bending superelastic wire relative motions of the stylet and cannula being considered, the
stylet is straightened by withdrawing it inside a cannula, while
A relation between the location of the superelastic transition
the distal end maintains its preformed curvature. We assume
zone, RSE, and the neutral axis, R, can be identified based on
that because of this incremental straightened, starting at the
the superelastic transition stress σSE in a curved beam with
proximal end and finishing at the distal end, that our
elastic stress distribution.
assumptions for EIeff and R are a reasonable first order
R − RSE
σ SE = Ek (2) estimate. Due to the path dependent or dynamic nature of the
RSE problem future models could be developed to obtain a more
CONFIDENTIAL - NOT FOR PUBLIC DISCLOSURE 6

accurate estimation of the energy. .The bending moment, M, in curvature between the outer edge of the cannula and the
the stylet is given by cannula’s upper wall as shown.
M = FR cos θ (7) Fretract = − F friction − Fnh
Substituting EIeff and M into the equation and integrating EI eff sin(θ ) EI eff sin(θ )
Fretract = −2 µ −
along the length of the curved beam, i.e. from zero to θ the ⎡ θ 1 ⎤ ⎛ ⎞
R 2 ⎢ + sin(2θ ) ⎥ R 2 ⎡ θ + 1 sin(2θ ) ⎤ tan ⎜ arcsin ⎛⎜ 1 − D − d ⎞⎟ ⎟
energy is ⎣2 4 ⎦ ⎢2 4 ⎥ ρ ⎠⎠
⎣ ⎦ ⎝ ⎝
θ
1 F 2 ρ 2 cos 2 (θ ) ρ The proceeding analysis was solved using Maple where first
U=
2 ∫ EI eff
dθ equations (3) and (4) were numerically solved to find R and
0 (8) RSE and then the values of Fdeploy and Fretract were calculated.
F 2 ρ 3 ⎡θ 1 ⎤
U= ⎢ + sin ( 2θ ) ⎥
EI eff ⎣ 2 4 ⎦ Experimental Analysis
To validate the analysis, experiments were performed to
The end-point deflection, at θ, due to force F can be expressed determine the required forces for relative motion between a
as cannula and a pre-bent stylet. To achieve this, a fixture and
∂U
δ = ρ sin(θ ) = (9) procedure were first developed for manufacturing Nitinol
∂F stylets with varying wire diameter and bend radius. An
Evaluating and solving for F yields experimental rig was then developed that enabled these stylets
EI eff sin(θ ) to be deployed from and withdrawn into a subset of stainless
F= (10) steel cannulas of various diameters.
⎡θ 1 ⎤
R 2 ⎢ + sin(2θ ) ⎥ The fixture, shown in Figure 8 maintained the Nitinol in its
⎣2 4 ⎦ final desired shape through heating and quenching while
Maximum deployment and retraction force providing minimal thermal resistance to ensure rapid
Knowing F, the frictional force between the cannula and the quenching.
bent stylet can be calculated based on the assumption that, in a
Upper Picture
cannula, a straightening force and its corresponding normal Frame
reaction force, also equal to F, are applied and supported at
two points within the cannula (Figure 4). Thus
EI eff sin(θ )
F friction = 2µ F = 2µ (11) Upper Vent
2 ⎡θ 1 ⎤ Plate
R ⎢ + sin(2θ ) ⎥
⎣2 4 ⎦ Outline Plate
The maximum deployment force is when the stylet is fully
inside the cannula. Evaluating for a ninety degree bend, i.e at
π/2 Lower Vent
Plate
8µ EI eff
Fdeploy = (12)
π R2
Figure 7 shows that the stylet enters the cannula an incident
angle, and therefore, a horizontal and vertical component of
retraction force is expected.
Wire Locating Lower Picture
Plate Frame
d
D FN
Figure 8 – Nitinol Quench Fixture
Fnh
Fn The primary bars are 2.5–4X the thickness of the bar to
maximize exposed quench area, while minimizing rig
ρ deformation. For experimentation, the cannulas were mounted
ρ-(D-d)
in a custom-made needle testing fixture shown in Figure 9.
The fixture was designed to (1) bolt to an ADMET universal
testing machine, (2) hold a cannula rigidly and vertically, and
θNormal (3) provide enough space for ballistics gel samples to be held
Figure 7 – Forces on stylet as it enters the cannula under a cannula for future experiments. The cannula was held
in a pin vice attached to the rig and a matching pin vice
screwed into the load cell above the test fixture to hold the
To calculate the full retraction force required to draw a stylet.
needle into the cannula, Fnh is calculated to sum with the
friction force. To find Fnh, the angle of the normal force FN is
found with the assumption that the wire maintains its radius of
CONFIDENTIAL - NOT FOR PUBLIC DISCLOSURE 7

Cannula Chuck System Comparison to Analytical Model


Fixture To examine trends in deployment and retraction force for
varying cannula diameter, stylet diameter, and bend radius, the
deployment force as a function of the various combinations of
Cannula
cannula diameter, stylet diameter and bend radius and the data
for a 16G cannula is shown in Figure 11 and compared to the
analytical model. The error bars on the experimental data
Pre-Ben
Needle
represent the standard deviation between five experimental
runs at each data point. Exponential curve fits are included in
the plots to display trends so as to easily compare the
experimental data to the analytical model.
Deployment Force of Pre‐Bent Needle in 16G Cannula

20

18

16 .508mm
Figure 9 – Needle Testing Fixture .635mm
14 .838mm

Deployment Force (N)
.990mm

Data were recorded for 48 permutations of cannula 12 .508mm Analyze


.635mm Analyze
diameter, wire diameter, and bend radius to identify trends 10
.838mm Analyze

across all three dimensions. At the beginning of each test the 8 .990mm Analyze
Expon. (.508mm)

PC was set to record data and deploy the stylet at 7.5mm/sec, a 6 Expon. (.635mm)
Expon. (.838mm)

cannula was flushed with Isopropyl alcohol and attached to the 4 Expon. (.990mm)

Needle Testing Fixture to let dry, and a stylet was cleaned by 2

the experimenter with Kimwipes and Isopropyl alcohol. Figure 0


0 5 10 15 20 25 30 35 40 45
10 illustrates the force-time data for a .508 mm wire with a 30 Needle Bend Radius (mm)
mm bend radius in a 14 gauge cannula.
Figure 11 – Deployment Force vs. Bend Radius plots for .508mm-
14-.508-30-7.5 .990mm stylets with 10mm-40mm bend radii deployed through a 16G
cannula at 7.5mm/sec
0.6
C. Deflection of the Tip of the Needle
0.4
Stylet
Retraction
Stylet in
Cannula When the stylet is deployed from the cannula inside the body it
Series1
0.2 will experience a force tangential to its tip (assuming a
Load (N)

Series2
0 Series3
symmetric beveled tip) due to cutting of the tissue. The force
0 5 10 15 20 25 Series4 required to puncture a tumor is typically higher than the force
-0.2
Series5 to cut through healthy tissue. As such we desire the stylet to be
designed to be sufficiently stiff so as to it does not deflect
-0.4
Stylet in Stylet appreciably under the expected cutting forces of a particular
Cannula Deployment
-0.6 tissue. The deflection of the end-point can be assumed to a
Time (s) measure of the performance of a stylet with particular material
properties and geometry. We can estimate this by assuming
Figure 10 – Load vs. Time plot for 5 runs of .508mm stylet with 30mm that the cannula is grounded, the stylet is fully deployed and
bend radius deployed through a 14G cannula at 7.5mm/sec rigidly attached to the cannula at the exit point.
In reality the deflection of the curved stylet is going to also
Starting from the left of the time axis, relative motion
be a function of the stiffness of the tissue that surrounds it and
between the stylet and cannula when the stylet was completely
the tissue will act to limit its deflection. The effect of the tissue
within the cannula produced a nearly constant force as
can be adding by considering the stylet as a beam on elastic
measured with the load cell. As the stylet was deployed from
foundation [27]. Figure 12 shows the model of the curved
the cannula the force was observed to decrease until it reached
beam with the elastic foundation included. The differential
a level close to zero when the curved portion of the stylet was
element is also shown and the model assumes that the reaction
completely deployed. Some small force was still observed due
forces in the foundation are normal to the axis of the beam and
to slight misalignment between the cannula and stylet. The
proportional at every point to the radial deflection, y, of the
direction of movement of the ADMET machine was then
beam at that point. The reaction of the foundation per unit
reversed and hence the sign of the force changes. Retraction of
length of the beam, p, is given by
the stylet into the cannula resulted in an increasing force that
p = ky (13)
reached a peak and then reduced to a steady state value that
was of a similar value to that observed just before the stylet Since y is taken to act radially and oppose the deflection of the
was deployed from the cannula as we expected. beam, a positive displacement, when the radius of curvature is
CONFIDENTIAL - NOT FOR PUBLIC DISCLOSURE 8

increasing, will result from a tangential force as shown in y (0) = 0 (21)


Figure 12 and the elastic medium will be assumed to be in dy
compression. In this model the elastic foundation is also (0) = 0 (22)
assumed to represent tensile forces to mimic tissue on the other d θ
side of the stylet. Q(π ) = 0 (23)
2
Equation (13) implies that the supporting medium is elastic.
Organ tissue has been shown to have nonlinear material M (π ) = 0 (24)
2
properties [28] but for small strains it can be assumed to be
approximately linear with a young’s modulus of 100 kPa. As it N (π ) = F (25)
2
essentially acts as a stiffening spring, this assumption will be
conservative in estimating the end point stylet deflection. Based on a tissue cutting force of 3 N, this analysis yielded
that the radial deflections of the end-points ranged between 0.5
and 2.5 mm. Targeting experiments are planned (see Future
Work) to experimentally measure the end-point deflection of a
stylet deployed from a cannula into ballistics gelatin.

IV. MECHANICAL DESIGN


Based on the analysis and experimental data a prototype
telerobotic mechanism using the principle of a pre-curved
Figure 12 – Curved beam on elastic foundation and differential
stylet concentric with a stiffer outer cannula was developed.
element The system is capable of axially advancing and rotating a
cannula and axially advancing a stylet though the cannula. The
The infinitesimal differential element is acted on by the
telerobot was designed to be attached to an access cannula that
shearing force, Q, normal force, N, bending moment, M and
is first placed close to the desired target volume as illustrated
reaction force of the foundation pdx. From the conditions of
equilibrium acting on the differential element we can derive in .
dy 1 dM d 3 M
k − = (14)
dx r 2 dx dx3
and the differential equation of bending of a circular arch of
radius of curvature r and flexural rigidity EI is
⎛ d2y y ⎞
EI ⎜ 2 + 2 ⎟ = − M (15)
⎜ dx r ⎟⎠

Combining these, the fundamental differential equation of
bending of circular beams supported on elastic foundation is
then
d5 y 2 d3y ⎛ k 1 ⎞ dy
5
+ 2 3 +⎜ + 4⎟ =0 (16)
dx r dx ⎝ EI r ⎠ dx
which can be written in terms of θ Figure 13 – Concept of attaching the telerobot to a pre-inserted
access cannula and targeting multiple points in a volume through
d5y d3y 2 dy advancement and rotation of the components.
+ 2 + η = 0 (17)
dθ 5 dθ 3 dx The depth to which the access cannula is placed is typically 5-
where 15 cm and the telerobot would be attached to the access needle
4
r k via a standard medical leur-lock connector. An advantage of
η= +1 (18) this approach is that the access cannula can be either placed
EI
manually by the physician or with the aid of a patient mounted
This general solution for this equation is
robot such as Robopsy [29]; however, if placed manually,
y = C0 + ( C1Coshαθ + C2 Sinhαθ ) cos βθ + ...
(19) there must be a means of supporting the access cannula and the
... ( C2 Coshαθ + C4 Sinhαθ ) sin βθ attached mass of the telerobot. Further, this approach also
where C0, C1, C2, C3 and C4 are the constants of integration and enables the system to be used within the size constraints of a
medical imaging system as the overall height requirement is
η −1 η +1
α= and β = (20) reduced by first placing the access cannula. Alternatively, the
2 2 system could easily be attached to the end of a robotic arm that
The boundary conditions for the stylet in tissue with a the can perform the first gross insertion and in this case, no access
proximal end of the curved segment assumed to be grounded needle is required.
and a tangential force at the distal end yield five equations that The prototype system is shown in Figure 14 and is designed
can be used to solve for the five unknown integration constants
to be made from largely plastic components for CT
CONFIDENTIAL - NOT FOR PUBLIC DISCLOSURE 9

compatibility. Actuation of the system is achieved using micro torque to raise a load is
stepper motors. The system height and diameter are 15 cm and Fd m ⎛ l + πµ d m sec α ⎞
5 cm respectively with a weight of approximately 180 grams. T= ⎜ ⎟ (26)
2 ⎝ π d m − µ l sec α ⎠
Where F is the desired maximum force, dm is the pitch
diameter of the lead screw, l is the lead, µ is the coefficient of
friction between the threads and α is the ACME thread angle
(i.e. 29˚). Using a simple sliding test, the coefficient of sliding
friction of Acetal on Acetal was found to be 0.2. The pitch
diameter for each of the threaded profiles was obtained from a
combination of size and strength constraints as discussed later.
The stepper motors selected for this application are 10 mm
diameter (AM1020, Faulhaber Inc) and have a holding torque
of 2.4 mNm. Knowing the lead of 1/16 inch (1.5875mm) for
the cannula and stylet we can rearrange equation (26) to find
the maximum axial force obtainable. This analysis suggests
that it was necessary to also have a gear reduction between the
motor shaft and the nut on the screw. Achieving a higher
transmission ratio by choosing a lower lead would require a
non-standard ACME pitch and further, is not effective as the
Figure 14 – Section view of the needle steering system.. efficiency of power transmission of the screw is proportional
to the lead. If T0 is the torque achievable assuming no frictional
The device has a protruding cannula with a stylet with a
losses due to sliding contact between the threads the efficiency,
curved distal tip pre-assembled inside. The proximal end of the
e, for power transmission with a screw is given by
cannula is attached to the distal end of a screw-spline that
T Fl
enables it to be translated and rotated with respect to the e= 0 = (27)
casing. The screw-spline is a modified plastic ACME threaded T 2 πT
screw that also has a splined groove along its length. Nuts 1 The preferred option to increase the maximum achievable
and 2 (that are driven by micro stepper motors through spur force was to use a planetary drive attached to the micro stepper
gears) engage the screw threads and spline respectively. Nut 1 motors and a further gear reduction between the gearhead
has a bore that is threaded to match the lead of the screw and pinion and nuts. The planetary gearhead that was chosen had a
Nut 2 has a keyed feature that engages the spline. Translation two-stage 16:1 reduction (10/1 from Faulhaber) with a rated
of the stylet is achieved in a similar way in that it is a second efficiency of 80%. A further gear reduction of 2 between spur
ACME threaded screw with a splined groove. A keyed feature gears on the gearhead pinions and each of the screw or splined
on the inside of the screw-spline mates with the splined groove nuts had an estimated efficiency of 90%.
to constrain it from rotating. Further, this key also causes it to
rotate with the cannula as the screw-spline is rotated. The
cannula and stylet both attach to the screw-spline and screw
respectively via plastic threaded inserts that are bonded to the
proximal end of the cannula and stylet. The length of the
cannula and stylet are chosen so as to be positioned at the Spline Nut 
distal tip of the access cannula when the parts are connected Screw Nut 
via a standard medical leur-lock.
A. Transmission Selection
The theoretical and experimental results of section III yielded
Figure 15 – Screw-spline drive components.
the forces and torques required to withdraw a curved stylet into
and deploy it from an outer cannula. Using these numbers and Use of a gear reduction between the motor output and screw
preciously reported results from measuring the force to and spline nuts also meant that the stepper motor could be used
advance a needle in tissue as design specifications, the to constrain the screw-spline from rotating during a
appropriate motors and transmissions were then selected. commanded pure translation or during a deployment of the
When choosing a leadscrew it is important to determine the stylet. Further, use of this gear reduction improved the angular
necessary torque to be applied so as exert sufficient axial force and linear resolution of the system as the step size for the
(i.e. for cutting through tissue and overcome friction between motors is 18˚. During operation of the device the cannula and
cannula and stylet), overcome frictional forces due to sliding stylet will be activated independently. As such, it will be
contact between the threads and also any other friction forces necessary for the cannula to retain its axial position when the
arising from bearings. The general equation for calculating the stylet is being translated and vice versa. An inherent advantage
CONFIDENTIAL - NOT FOR PUBLIC DISCLOSURE 10

of using the ACME screws for achieving translation of the Where dk is the diameter where the key engages to transmit the
stylet and cannula is that they are non-backdrivable. torque.
B. Strength Analysis Spur Gears
As mentioned earlier the strength of the components also Spur gears transmit torque by generating forces between the
determined the sizing of the mechanism as well as geometry gear teeth. Thus a torque transmitted at a pitch diameter, dp,
constraints. In order to ensure that the structure could results in a radial load, Fradial, on the shaft on which the gear is
withstand the forces and torques exerted on it, an analysis of mounted, given by
the stresses in the leadscrew and gears were calculated. The
2T
axial and radial loads on the nut and gearhead bearings were Fradial = (32)
also calculated to ensure that the rated load capacities of the dp
bearings were not exceeded. Further, a pressure angle φ, between the gear teeth generates a
force that acts to spread the gears apart
Cannula and Stylet Leadscrews Fspread = Fradial sin φ (33)
The axial stress in a screw due to a load, F, is given by
4F Thus, to ensure that the gearhead shafts were not overloaded
σ= (28) the spur gears on the motor pinion were placed directly in line
π (d r − di ) 2 with the bearings from the gearhead shaft. The plastic nut spur
where dr and di are the root and inside diameter of the gears were also mounted in bearings that were embedded and
leadscrew respectively. Assuming a solid screw, the nominal glued into the plastic mounting plate. This ensures that the
shear stress in torsion, T, in the leadscrew is given by supporting structure and spur gears hubs would be sufficiently
16T stiff so that the teeth would always remain engaged.
τ= 3
(29)
π dr C. Component Sizing and Selection
Assuming a stress concentration of two, the vonMises A functional requirement for the system was that it could be
equivalent stress can be calculated from compatible with CT machines. As such, the system parts were
2
σ equivelent = 2 * σ + 3τ 2
(30) designed to be constructed largely of plastic. Plastic parts do
show up on CT images but because of their low density they
In Figure 16 a plot of σequivalent is shown as a function of root do not cause shadowing artifacts. The stepper motors and
diameter (ranging from 5 to 12 mm) and applied axial force. It planetary gearheads used for actuation will result in shadowing
can be seen that the stress is always below the yield stress of
artifacts; although they were placed away from the central axis
Nylon of 60 MPa. Based on this analysis the root diameter for
of the cannula and stylet so as to minimize distortion to the
the stylet screw was chosen to be 5 mm to ensure a factor of
images. Another requirement was that the system should have
safety of approximately 3.
sufficient travel so as to target a volume on the order of 125
15 mm3 while also being compact enough so as to fit inside the
Axial Force = 5N
Axial Force = 10N bore of an imaging machine. This requirement, along with the
Axial Force = 15N strength analysis discussed previously drove the sizing of the
Axial Force = 20N system.
Von Mises Stress (MPa)

10 A 6mm outer diameter lead screw was chosen axial


movement of the stylet. This screw was concentrically nested
inside an 11mm diameter hollow plastic screw-spline. The nuts
for the screw and screw-spline were manufactured from off-
5 the-shelf Acetal spur gears; 24 mm pitch diameter for the
cannula screw-spline nuts and 22.5 mm pitch diameter for the
stylet screw. The spur gear nuts for the screws were internally
threaded with a 1/16 inch AMCE thread profile to match the
0
5 6 7 8 9 10 11 12
screws. The spur gear nut for the spline had a slot broached
Root Diameter (mm) into the inside diameter that allowed a small plastic 1.5 mm
Figure 16 – Equivalent vonMises stress in nylon screw as a function of
diameter key to be inserted as shown in Figure 15 previously.
root diameter and axial load This key then engaged the splined groove on the cannula
Spline screw-spline. A similar slot was machined into the top of the
The keyed feature for each of the splined grooves on the stylet screw-spline where an identical key was used to constrain the
and cannula screws was sized to ensure that it would be able to rotation of the stylet screw with the cannula screw-spline.
withstand the shear stresses generated due to torque Stainless Steel spur gears with a pitch diameter of 12 mm
transmission which is given by (SDP-SI) were used to transmit power from the planetary
2T gearhead to the plastic spur-gear nuts. A hubbed spur gear was
τ shear = (31) chosen so that the gear teeth were placed in line with the
dk A
sintered brass bearings in the planetary gearhead. A brass
CONFIDENTIAL - NOT FOR PUBLIC DISCLOSURE 11

insert was placed inside the 5mm bore of the spur gear and a
2mm diameter hole was drilled out. The gear was attached to
the gearhead shaft via a set screw that pushed up against a flat
on the shaft. The motors were clamped to their respective
mounting plates so to aid with gear alignment and repair. The
design was such that the same plastic clamp could be used for
each of the motors.
Ceramic bearings were used for attaching each of the nuts to
their respective mounting plates (VXB Bearing Inc.). These
bearings provided a compact non-metallic package with
sufficient axial and radial loadings for the forces we found in
Section III; however, they are brittle and expensive. Plastic
ball bearings were also considered but they have significantly
larger height and outside diameter for a given internal diameter
as well as approximately an order of magnitude higher axial Figure 17 - Coordinate system and position variables for cannula and
play. stylet
A cylindrical precision ground tube (McMaster-Carr) was
The radius of curvature of the distal portion of the stylet, R,
used to house all of the components. The tube has an internal
is assumed to remain constant when outside of the cannula.
tolerance of ±0.0005” and so provides the secondary purpose
The included angle between a line tangent to the tip of the
of a guide way for the flanges of the cannula screw-spline
stylet and the axis of the cannula is defined as θ (see Figure
assembly. In order to reduce friction between the flanges and
12) and it is related to the stylet curvature and displacement by
inside of the casing, 4-48 spring plungers (McMaster) were
threaded into the side of the flanges. Spring plungers provide a θ = zs R (34)
ball element at their tip that is attached to a spring and thus The total bend angle of an undeformed stylet is defined as
provide rolling contact on the casing for translation and θcurve with the total length being given by the arc length as
rotation of the screw-spline stages. Side hole were machined
into the casing to provide a means for attaching the mounting lcurve = θ curve * R (35)
plate for the motors that drive the screw-spline as well as the
top and base plates. A standard ¼-24 plastic leur-lock was which is the limit for stylet displacement relative to the
threaded into base plate for attaching to standard medical cannula. The relationship between the curved needle and
needles for access to the target site. general cylindrical coordinates can be solved to yield the
forward and inverse kinematics.
V. CONTROL
The current embodiment of the system is designed to be Forward Kinematics
controlled based on open-loop command signals sent to the From Figure 17 it can be seen that in the ρ-z plane the position
stepper motors. The appropriate kinematic equations were of the tip of the curved stylet is a function of the radius of
derived that relate the motor angular positions to the distal tip curvature of the stylet, R, and the amount it is extended from
of the stylet. A simple user interface was developed that allows the cannula, zs, and the axial position of the cannula with
a user to specify a desired position within a volume. respect to the casing, zc. Thus, from simple geometry we can
As discussed earlier, in order to reposition the distal tip of derive
the stylet within a volume requires that the cannula be ρ = R (1 − cos ⎛⎜ zs R ⎞⎟) (36)
translated and rotated relative to the casing and the stylet be ⎝ ⎠
translated relative to the cannula. A schematic of the cannula
z = zc + R sin ⎛⎜ s ⎞⎟
z
(37)
and stylet is shown in Figure 17 with the distal tip of the stylet ⎝ R⎠
defined in standard Cartesian and cylindrical coordinate The angle between the positive x-axis and the ρ-z plane is
systems. Position variables to represent the motions of the simply the angle of rotation between the cannula and the
cannula and stylet are also shown. Here we outline the casing.
necessary equations for determining the appropriate motor
commands to position to a point in a CT coordinate system. ϕ = θc (38)
Inverse Kinematics
Rearranging equations (36), (37) and (38) the equations
relating the actuated degrees of freedom to a desired end-point
in cylindrical coordinates can be obtained.

(
zs = R cos −1 1 − ρ
R ) (39)
CONFIDENTIAL - NOT FOR PUBLIC DISCLOSURE 12

zc = z − R sin ⎛⎜ s ⎞⎟)
z
⎝ R⎠ (40)

θc = ϕ (41)
If a desired end-point of the stylet is first defined in Cartesian
coordinates then this point can first be transformed to
cylindrical coordinates before the cannula and stylet positions
are calculated.

Mechanism Control
The next step is to determine the necessary commands to be
sent to the motors to achieve the desired zc, θc and zs so as to
position the tip of the stylet at the desired location. The screw-
spline concept was discussed earlier in Section IV where either
pure translation or rotation of the cannula requires control of
both motors. Table 1 illustrates how the three modes of
Figure 18 - Prototype User Interface for controlling all axes individually
operation possible (translation, rotation and spiral) are or prescribing a position of the end-point of the stylet in cylindrical or
obtained as well as how the screw and spline nut inputs relate Cartesian coordinates
to the output motions.
User inputs may be specified in cylindrical or Cartesian
Table 1 – Modes of operation of screw-spline mechanism
coordinates that are then converted into desired rotations and
Input Cannula Movement speed and sent to the controller which in turn sends step
Mode Screw Nut Spline Nut Translation Rotation commands to the individual motor drivers. This interface will
serve the purposes of validated that a volume can be targeted
ω1 0 v = ω1 l 0 with the device.

ω1 = ω2 ω2 0 ω2 VII. CONCLUSION & FUTURE WORK


In this paper we have outlined developed a telerobot capable
0 ω2 v = ω2 l ω2 of repositioning the distal tip of a percutaneous instrument,

after it has been inserted into the body. The analysis and
The equations for calculating the desired stylet screw nut
experimental models developed will enable the system to be
angle, φs, and the angles for the cannula screw, φss1, and spline,
easily scaled for other medical procedures. Medical imaging
φss2, based a desired position for the cannula for a commanded
system such as CT provides very high resolution images and
translation are
ultimately, these commands will come from a 3D planning
2π 
φss1 = zc / g and φss 2 = 0 (42)(43) interface that directly integrates the medical images in a similar
lss manner to [30].
And for a commanded rotation are Evaluation of the system is planned so as to characterize the
φss 2 = θ c / g and φss1 = φss 2 (44)(45) targeting accuracy that can be achieved. Figure 19 illustrates
and for a commanded translation of the stylet is the designed experimental setup for evaluation of the system.

φs = z s / c (46)
ls
where lss and ls are the lead of the cannula screw-spline and
stylet screw respectively.

VI. ELECTRONICS IMPLEMENTATION


The drive electronics for the system are contained in a control
box that would be located away for the patient on the CT bed.
It is plugged into a standard 120 V wall outlet and connected
via a USB cable to a laptop. Inside the box are off–the–shelf
components; a USB stepper motor controller (ARCUS Inc.),
power supply (Name) and four stepper motor drivers (Name).
The controller allows the system to be actuated remotely from
the CT control room. A prototype software interface was
developed that allows the movement of the cannula and stylet Figure 19 - Experimental setup for evaluation of telerobot
to be controlled. The cannula and stylet will be deployed to multiple points
into ballistics gelatin that is cast into a transparent container. A
CONFIDENTIAL - NOT FOR PUBLIC DISCLOSURE 13

grid is imprinted onto the back of the container so that images [14] G. B. Chung, S. M. Kim, S. G. Lee, B.-J. Yi, W. Kim, S. M. Oh, Y. S.
Kim, B. R. So, J. I. Park, and S. H. Oh, "An Image-Guided Robotic
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[15] B. Maurin, C. Doignon, J. Gangloff, B. Bayle, M. d. Mathelin, O. Piccin,
ACKNOWLEDGMENT and A. Gangi, "CTBot: A stereotactic-guided robotic assistant for
percutaneous procedures of the abdomen," in Medical Imaging 2005:
The authors wish to express their sincere appreciation to the Visualization, Image-Guided Procedures, and Display, 2005, pp. 241-
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[16] A. Patriciu, S. Solomon, L. Kavoussi, and D. Stoianovici, "Robotic
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