An endoscope is an instrument used to examine the interior of a patient's body. Endoscopes are used for diagnosis and/or treatment in a number of areas, including, for example, in the gastrointestinal or respiratory systems. Most flexible endoscopes utilize cable systems to manipulate the position of the tip to provide directional control during placement of the endoscope within a human or animal body. The user typically manually adjusts the position of the cables from the proximal end of the endoscope, which consequently subjects the cable system to capstan friction forces throughout the body of the endoscope. This defines the amount of force that must be applied to the cable system and tends to increase the amount of force applied to the tip of the endoscope. Higher lateral tip forces increase the risk of perforation of the body lumen in which the endoscope is being moved. It is also advantageous for the endoscope to have longitudinal stiffness during insertion, yet be flexible during retraction to reduce the risk of endoscope looping and perforation.
Another important factor in endoscope design is to minimize the risks and costs associated with the sterilization of components. There is, consequently, a continuing need for improvements in endoscope design for both medical and industrial use.
The present invention relates to a system for directional control of an endoscope. A preferred embodiment of the invention comprises an endoscope system having a steerable distal end to facilitate insertion into body lumens. The endoscope system can employ a motorized control system to actuate deflection of the distal end of the endoscope. By locating the actuator used to control the tip at or near the distal end of the endoscope, tip forces and input force variation can be reduced. When the cable system is actuated from the proximal end of the endoscope, as in conventional steerable systems, the cable system is subject to capstan friction forces throughout the endoscope body. This increases the maximum force that the operator must use at the proximal end, thereby increasing the range of forces that can be seen at the tip of the endoscope. However, with the distal actuator placed at or near the tip, the capstan friction is lower so that the maximum force at the tip can be more tightly controlled. The removal of the cables needed for tip control from the proximal body of the endoscope also reduces the complexity and cost of a disposable portion of the system. Further, the system is capable of turning speeds in excess of 400 degrees per second for fast response and control. In a further preferred embodiment, the system can use higher torque in order to bend flexible biopsy tools inserted through an endoscope channel or lumen.
A preferred embodiment of the invention includes a disposable elongate body section that is detachable from a handle with a connector. The elongate body section is adapted for at least partial insertion in a human or animal body. The elongate body is attached at the distal end to a motorized section that includes a motor to actuate deflection of a flexible section. The distal end of the flexible section can be attached to a distal housing that can contain devices or instruments for particular procedures. A preferred embodiment of the distal housing can include a light source, angular displacement sensors such as gyroscopes, and an electronic image sensor or camera for visualization. The distal section can be detached and cleaned for reuse or can be readily replaced if damaged.
The system is designed to limit the force applied by the tip to the tissue when it is deflected. The torque that is applied by the motor on the tip has an upper limit that can be selected integral with the design, or it can be adjusted as a programmable parameter by the user. Alternatively, a further preferred embodiment measures the force imparted by the tip on the tissue, which can be displayed to the user. Additionally, a haptic feedback system can used to give the user a tactile sense of the level of force being imparted.
The modular design is preferably selected to reduce manufacturing cost and permit simple adjustment in length. In one embodiment, the modular design allows for the disposal of the most difficult-to-clean sections of the endoscope, which typically includes the body section 101, motor module 103 and turning section 105. In one preferred embodiment, all components except the tip module 107 can be designed to be low cost and disposable. The tip module 107 is generally non-disposable and can be separately sealed, thereby mitigating contamination.
As shown in
The endoscope 100 can include at least one inner lumen that extends continuously along the length of the endoscope 100 and through the tip module 107 to allow use of a guidewire, tool or other device. A plurality of smaller channels extend from the motor module 103 through the turning section 105 and house the control cables that control the bending action of the endoscope 100, as described in further detail below. The motor module 103 houses the motor 120 that drive the bending motion of the endoscope 100.
In certain embodiments, the body section 101 of the endoscope 100 includes a variable stiffness feature. Variable stiffness allows the endoscope 100 to be stiffened when it enters the patient's body so that it can be easily inserted and advanced. When the endoscope exits the body, the stiffness can be reduced so that it can be easily withdrawn from the body without causing damage and so that loops in the endoscope can be resolved. In addition, the variable stiffness can be adjusted below the perforation threshold for patients that may be more susceptible.
The safety module 108 can be utilized to cut the control cables in the event that the motor(s) malfunction while the tip is bent. This allows the endoscope to be withdrawn without causing injury. Since the turning section 105 is included in the disposable portion of the endoscope, cutting the control cables is not problematic. If higher holding forces are necessary for the tip of the endoscope, additional module(s) can be added to help hold the cables in place.
The distal section or module 107 can include an imaging detector, such as a CCD or CMOS imager and a light source(s) such as one or more light emitting diodes (LEDs) or lasers. Additional instruments for biopsy and other procedures can be passed down the inner lumen.
It is particularly advantageous to reduce the cable length L extending from the distal end of the motor section 103 to the proximal end of the flexible section 105. The distance L is preferably less than 20 mm, and more preferably is less than 10 mm. For example, length L can be in a range of 1 to 10 mm. Larger lengths can be used to accommodate a safety module, for example. If two motors are positioned longitudinally along the length of the motorized section, the cable system for the proximal motor can be longer than the cable system for the distal motor. In the case of a motorized section with 4 motors, such as two pairs of stepper motors, there can be two pairs of cables having different lengths.
The endoscope 100 also includes at least one connector that allows various segments of the endoscope to be attached to and detached from one another. In one embodiment, connector 165 connects the tip module 107 to an endoscope sub-assembly that includes the body section 101, motor module 103 and turning section 105. In one preferred embodiment, the tip module 107 is reusable, and is removed from the sub-assembly by detaching the tip 107 at the connector 165. The sub-assembly comprising the turning section 105, motor module 103 and body section 101 is disposable, and can be discarded after use.
In another embodiment, connector 164 attaches the body section 101 to a sub-assembly that includes at least the motor module 103 and turning section 105. In this embodiment, the body section 101 can be separated from the rest of the endoscope and either sterilized for reuse, or discarded, as appropriate. Similarly, the motor module 103 and turning section 105 can be reusable, though generally these components will be disposable and discarded after use.
Although the embodiment of
The connectors 164, 165 generally utilize a plug and socket that provides both physical and electrical connection between adjoining sections and/or modules of the endoscope 100. The connectors also include openings to allow the passage of channels, such as the inner lumen, between the adjoining sections and/or modules of the endoscope 100. Examples of connectors 164, 165 according to one embodiment are shown in
In the embodiment of
In the embodiment of
A computer with the user interface, includes memory and a processor for executing stored instructions, and controls the overall operation of the endoscope 100. The computer can generate control signals that control the operation of one or more motors within motor module 103 that in turn drive control cables within the turning section 105 and steer the tip module 107 in the desired direction. The motor control signals can be generated in response to user commands from an interface device 206 or control panel 220, and in some embodiments, can be generated in response to feedback signals received from sensing devices on the endoscope. The computer can also control the imaging functions for display 222 and motion of the endoscope 101, and receives and processes image signals received from an image sensing device, such as a CCD camera, located in the tip module 107. The computer can further include a display device for displaying images received from the endoscope tip 107.
In a preferred embodiment, the control system 300 can be configured as shown in
The circuit board 322 can include the camera, the camera chip and light source chip. The distal housing can be sealed 325 and is reusable using cleaning and sterilization techniques. The flexible section 105 can form a reusable endoscope component with the motorized section 103 and distal housing 107 or alternatively can be detached and disposed of after a single use.
Another preferred embodiment of a control system 350 is illustrated in
In one embodiment, the drive electronics for the endoscope system use H-bridges and an adjustable pulse width modulation (PMW) in order to obtain high instantaneous torques and for speed control of two degrees of motion. For example, the system can be controlled with a NI USP-6501 data acquisition system and L298 H-bridges. A Logitech® Attack™ 3 joystick and software written in NI LabVIEW 8.5, Visual Basic, or embedded C can be used to control the position of the tip of the endoscope. The endoscope can also be constructed with force sensors to measure and indicate the level of force applied to the tissue by the tip. The measured force can also be used to provide haptic feedback to the user through the handle to provide tactile sense of the level of force. The system can be programmed to limit the amount of force applied either by limiting the input to the motor or by feedback measurement of strain (where strain gages are placed along the length of the turning section 105) tip contact force (where sensors 465 are placed around the outside of 107), or through other methods. Position can be measured using two gyroscopes 312, 314 (one placed at the motor modules 103 and one placed at the tip 107 for a relative measurement), using strain gages (placed along the length of the turning section 105), using capacitive distance sensing (placing capacitive sensors 465 at the tip 107 or on any of the turning modules 105), using instruments to measure the string length (using potentiometers, encoders or other sensors to register the location of the motor shaft or string length placed at 103 or along 105), or through other methods. If the force is determined to be too high, the command to the motor can be reduced using negative feedback or the motor is driven to a safer position where less force is applied. To prevent perforations due to hooking, the tip can be straightened or driven to a safe position using the control system when the endoscope is withdrawn.
Various tools 475 can optionally be integrated into the distal housing 107 for manipulating devices for surgical procedures such as biopsy, resection, cautery or suturing.
A schematic illustration of a haptic feedback system 380 is shown in
Illustrated in
The body section 101 in the embodiment of
The body module 162 in this embodiment includes a generally disc-shaped, portion 255 having a first diameter and a spacer portion 258 having a second, smaller diameter. The spacer portion 258 extends in an axial direction from one surface of the disc-shaped portion 255. The central lumen opening extends through both the disk-shaped portion 255 and the spacer portion. The spacer portion is designed to provide spacing between the adjacent modules of the body section 101, and also facilitates the pivoting motion of the adjacent modules relative to one another. In the embodiment of
In the embodiment of
In one embodiment, the motor 120 is a planetary geared motor, such as the GM15 pager motor from Solarbotics, Ltd. of Calgary, Alberta, which has a gear ratio of about 25:1 or higher. In one exemplary embodiment, the motor 120 has a diameter of approximately 6 mm, a length of about 20 mm, and a weight of about 1.2 grams. The motor in this embodiment is designed for 3 to 6 V operation, providing 1200 RPM while drawing 100 mA. The stall torque is over 20 g-cm.
The system is easily scaled to other sizes. Other motors can be used that have a sufficiently high output torque. Other suitable motors include several motors from Maxon Motor ag of Sachseln, Switzerland (www.maxonmotor.com), including, without limitation, Maxon model nos. 349190, 349191, 349192, 349189, 250101 and 310599, which can be combined with Maxon gear nos. 304179, 304180 and 304181.
Illustrated in
The safety and holding modules can be implemented in several ways. The safety modules and holding modules can be actuated using a pull strings (as shown with the cables or strings 209 in
As shown in
Shown in
A preferred embodiment of a distal housing 107 is shown in the perspective and end views of
The force that the tip of the endoscope system can produce determines the maneuverability of the system. However, the tip force should not exceed the perforation force of healthy tissue (in the case of operator error). Therefore, a model can be used to guide the selection of the geared motor and articulated tip dimensions and force profile.
By balancing forces at the tip of the endoscope in the normal direction, it is possible to obtain Equation 2. The forces, in order, are the externally applied normal force (which is measured), the force associated with the spring constant, the force associated with damping, the force associated with inertia, and the internal normal force from cable tension. Results from other configurations with additional contact forces can be derived similarly.
F
ext
+F
k
+F
B
+F
J
−F
N=0 (2)
From measured data, it was found that the spring force is Fk=Kφ, the damping force is FB=B{dot over (φ)} and the inertial force is FJ=J{umlaut over (φ)}. Note that Equation 2 only exists for positive values of FN Fext and since the cable pulling procedure produces force in only one direction. The internal normal force from cable tension is related to the tangential string tension and this relation can be derived with a torque balance for the tip module at the very end. The tip force can be approximated using the capstan friction equation where μ is the coefficient of friction, Fin is the force output of the motor, and Ftip is the force measured at the tip. An extra π/2 term occurs due to the capstan friction in the 90° turn inside the rotary to linear transmission. This is shown in Equation 3.
The input force can be measured or calculated using the input voltage V, gear ratio N, motor constants Ke, and Kt, radius of the motor shaft r, resistance of the motor R, and angle of the motor shaft θ. Equation 4 shows this relation:
The full dynamics can be obtained in Equation 5:
A relationship between the motor angle and the bending angle can be derived from geometry. The relationship shown in Equation 6 is valid up to φmax. The approximation on the right can be used for small φ/n,
For a static system, Equation 5 reduces to Equation 7 for an input torque of Tin:
The spring constant K is a function of the elasticity of the endoscope tip (including the tool channel material, wire and tubing), the moment of inertia, and the length of the endoscope tip, d. The measured data can be used select the desired force and speed characteristics of the system.
The forces exerted by the endoscope tip were measured by holding the motor module fixed and measuring the force against the tip at different bending angles. The results of the measurements along with the analytical representation for the static tip force are plotted on
The measured spring constant in this example is 0.020 N/rad, the measured coefficient of static friction is 0.28 rad−1, and the measured coefficient of sliding friction is 0.10 rad−1. The data with standard deviation bars matches well with the predicted output for larger angles, but a low angle correction in the form 1+C1exp(−C2φ) is desirable for smaller angles. At low angles, the cable tension has more leverage than predicted by the representation because the play in the hole for the cable allows the selection of different bending points. The correction factor, which represents the exponentially decreasing leverage from cable tension, is multiplied with the tip force. In
In addition to the static tip forces, the dynamics of the endoscope can also be plotted using the dynamic model with Fext=0, and this is shown in
In order to assess the system, the tip forces are compared to the critical contact pressures of human organs, which are on the order of 20 kPa. This indicates that the resistive force of the organ is at minimum 0.64 N for a tip module of 11 mm in diameter and 2.9 mm in length. The system design produces forces well below this value and system parameters can be selected to prevent forces from reaching critical contact pressures in possible failure modes. Conventional endoscope designs with longer cable actuation mechanisms are susceptible to additional forces from bends in the body of the endoscope. The motor torques for these systems are much higher and the operator is more likely to produce tip forces that could potentially puncture organs. Thus, for each application, such as for the colon or other regions of the gastrointestinal system, the maximum force exerted by the distal end of the endoscope is maintained below a threshold force level defined by the perforation force for the type and condition of the tissue. Such force levels can be programmed into the computer for selection by the user thereby utilizing a plurality of programmable force levels that are stored in memory.
Having described the above illustrative embodiments of the presently disclosed tip actuated disposable endoscope, other alternative embodiments or variations may be made. For example, endoscopes are widely used for diagnostic purposes, but endoscopic procedures typically involve biopsies to remove tissue for further examination. Such endoscopes are operative to control the motion of not only the endoscope itself, but also any tools that are inserted within it for these types of procedures. Because biopsy tools are generally stiffer than the endoscope, such endoscopes can account for this stiffening when implementing an actuation method for turning.
As further shown in
The following analysis is provided to determine, a suitable gear efficiency of the worm assembly including the worm gear 1605 and the wheel 1606 (see
in which M1 is the worm torque, and D1 is the pitch diameter of the worm gear (see also
in which μ is the coefficient of friction, αn is the normal pressure angle (in degrees), and γ is the worm lead angle (in degrees). For example, αn is can be 20 degrees or any other suitable value.
Using equation (9) above, the output torque, M2, can be determined by multiplying the pitch radius of the worm wheel 1606 by the tangential force of the worm wheel 1606, as follows,
in which D2 is the pitch diameter of the worm wheel 1606 (see also
It is noted that the efficiency of the worm assembly can range from about 20% to close to 100% based on the geometry of the worm gear 1605 and the wheel 1606. The efficiency, E, can be calculated by dividing the output torque with friction by the output torque without friction, as follows.
The normal pressure angle, αn, for worm gears is typically 20 degrees, given low coefficients of friction. To optimize the efficiency, E, the worm lead angle, γ, can therefore be between 40 and 50 degrees. Accordingly, assuming a coefficient of friction value of about 0.3, the calculated efficiency, E, for the worm gear 1605 is about 56%.
It is further noted that materials that can be used to reduce friction include hardened steel for the worm gear 1605, and phosphor bronze for the worm wheel 1606. Such materials are typically strong enough such that the gear teeth will not fail under load. In accordance with an exemplary embodiment, the worm wheel 1606 and the worm gear 1605 can be made from hardened steel and 4042 steel, respectively. For example, the worm gear 1605 can be cut on an electric discharge machine. Further, the bearings for the motor module section 1600 can be made of brass, and can be encased by Acura 40 stereolythography material. There can also be a tool passage of about 4 mm in diameter within the casing. Such a case can be injection molded to reduce costs. The motor 1602 can be a low-cost gear head motor with a diameter of about 6 mm. The motor module 1610 can be a maximum of 14 mm in diameter, but can be scaled smaller as manufacturing methods are improved.
In accordance with another exemplary embodiment, the stiffness of the turning section of an endoscope incorporating the motor module section 1600 (see FIG. 16Aa) was measured, without a biopsy tool, as well as with two different biopsy tools (Pentax, Boston Scientific). In this exemplary embodiment, the length of the endoscope was about 60 mm. The measurement results, with and without the biopsy tools, are plotted in
In further accordance with this exemplary embodiment, stall force and force versus speed characteristics were measured, focusing on the motor module section 1600 and the performance of the worm assembly. The output stall force (measured as a pulling force on the monofilament cables) as a function of voltage is plotted in
In addition, endoscopic procedures such as colonoscopies, natural orifice translumenal endoscopic surgery, minimally invasive pericardioscopy, etc., can benefit from the present endoscope having features such as assisted tool positioning, closed loop position control, feature tracking and image stabilization, built-in force limits, and haptic feedback. Further, cauterization, ablation, and biopsy instruments are some exemplary tools used in conjunction with preferred embodiments of the present endoscope. When performing endoscopic procedures, medical professionals typically position tools, along with an endoscope camera, at several locations of interest. Using an endoscope with closed loop position control, feature tracking, and/or image stabilization, a user can be free to manipulate other tools, while the endoscope maintains the view of the camera or the location of one of the tools, thereby lessening the cost and reducing the complexity of such procedures.
The endoscopic robotic platform 1800 of
It is noted that the motor board 1910, which lays horizontally along the motor module 1804, houses a smaller form factor microprocessor, such as an Arm Cortex M3 microprocessor, which commands motor drivers in PWM mode, and measures motor current to control two actuation motors. The motor board 1910 also houses a three-axis gyroscope (“Gyro 2”), such as an InvenSense ITG-3200 gyroscope, which is used to determine the turning angle of the endoscope tip. The motor board 1910 can interface with the tip boards 1912 via a second synchronous serial peripheral interface bus. The tip boards 1912 include a VGA camera, such as a Toshiba TCM8230MD camera, which can communicate through 8-wire parallel lines with a smaller form factor microprocessor, such as an Arm Cortex M3 microprocessor. The tip boards 1912 also have an extension board with two white LED lights with luminous power of, for example, up to 120 lm.
The tip boards 1912, which can be under 12 mm in diameter and can contain a notch or lumen for a tool passage, house a three-axis gyroscope (“Gyro 1”). The two gyroscopes Gyro 1, Gyro 2 are operative to determine the relative angle between the motor module 1804 and the tip module 1808. The gyroscopes Gyro 1, Gyro 2 can be used to implement accurate blind turns (i.e., turns that may be outside the field of view of the camera), and to provide higher speed responses to angle perturbations than the camera and an image processing algorithm are able to output. Because of possible drift, the gyroscope integration and calibration can be done on a local board, and the gyroscopes can be used for relative turns.
The modular motorized design of the endoscopic robotic platform 1800 has several features for controls that involve inaccessible angular locations, nonlinearities in the drive dynamics, and windup delay when reversing inputs. For example, with one motor pulling in the x-axis of a coordinate system, and another motor pulling in the y-axis of the coordinate system, it may be impossible to access all possible angles if the x and y-axes are limited to 180 degrees. In addition, a single motor per axis with a linear-to-rotary transmission generally has one taut cable and one loose cable, which can cause windup delay when reversing directions. Further, the friction and backlash in the gearing may cause a dead-band at low input voltages. For example, the dead-band nonlinearity, and the input limit nonlinearity in the x (or y) direction can be modeled, as follows,
in which Vx is the input voltage, Vmin is the minimum voltage necessary to overcome static frictional losses in the system, and Vmax is the maximum input voltage to the motor.
The windup delay nonlinearity can also be modeled. If an input command is proceeding in one direction (grouped by Vinx>0 or Vinx<0), then the dynamic equation for angular movement in a single axis can be derived from a force balance, a torque balance, and by accounting for capstan friction. The windup delay nonlinearity can therefore be modeled (following earlier variable conventions except the angle is now denoted by the variable X),
in which J, B, and K describe the inertial, damping, and spring constants, respectively, Lh is the distance of a pull string from the center of the turning modules 1806, Ls is the radius of the spacer between the turning modules 1806, Dm is the height of the turning modules 1806, Ds is the height of the spacer, r is the radius of the torque transmission shaft, and μ is the coefficient of friction. Further, the maximum angular limit is
in which “Lm” is the radius of the turning modules 1806. The input torque, Tin, is a function of R, which is the resistance of the motor, Kt and Ke, which are the motor constants, N, which is the motor gear ratio, and n, which is the number of turning modules 1806. While one cable of length, sx1, is taut, the opposing cable of length, sx2, becomes looser, as follows,
s
x1
=d−L
h
x−nK
c
D
s
x,
s
x2
=d+L
h
x+nK
c
D
s
x, (15)
in which d is the length of the turning module section, and Kc is the compression of each of the spacers. When the motor changes directions (e.g., from Vinx>0 to Vinx<0, or vice versa), the motor winds up the loose cable, the tip angle is preserved, and all derivatives are set to zero (x=x, {dot over (x)}=0, {umlaut over (x)}=0). The wind up speed is a function of input voltage, and can be expressed as
In the event that the cable is taut (sx=d+Lhx), the single sided dynamic equations (see equations (13) above) can be solved. The equations (13) can then be used to predict the behavior of the robotic endoscope, and to guide the controller design.
To translate sensor readings into control inputs, the sensor information can be translated in a given sensor's frame of reference to the motor control frame of reference.
in which xi, yi, and zi are the rotational rate outputs (in radians/s) or integrated rotational angle outputs (in radians) of the sensors, and x*i and y*i are the desired readings used by the controller. The counterclockwise rotation angles α, β, and γ along the x, y, and z axes, respectively, are nominally αg1=0, βg1=π, and γg1=0 for the tip gyroscope (Gyro 1), and αg2=0, βg2=−π/2, and γg2=π/2 for the gyroscope (Gyro 2) in the motor module 1804 when calibrated to zero, while the motor module 1804 and the tip module 1808 are aligned. For the camera 1920, the rotational outputs for tracking objects, or for tracking relative motion, can be approximated for small rotations, as follows,
in which px is the displacement in the x-direction measured in pixels, tx is the total number of pixels in the x-direction, and fx is the field of view of the camera in the x-direction measured in radians. It is noted that an equation similar to equation (18) above can be determined for y.
To validate the model described above, exemplary experiments were conducted on the gyroscope control loop, since this is the primary controller that is used by the tip angle control loop 1902 and the image stabilization control loop 1906. The measured and simulated results for a gain-scheduled proportional and derivative control scheme involving blind (i.e., unaided by the camera) turns of ±45 degrees are depicted in
While the present invention has been described herein in conjunction with preferred embodiment, a person of ordinary skill in the art, can effect changes, substitutions or equivalents to the systems and methods described herein, which are intended to fall within the appended claims and any equivalents thereof.
This application claims the benefit of U.S. Provisional Application No. 61/377,765, filed Aug. 27, 2010 and U.S. Provisional Application No. 61/480,735 filed on Apr. 29, 2011, the entire contents of these applications being incorporated herein by reference.
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/US2011/049167 | 8/25/2011 | WO | 00 | 4/30/2014 |
Number | Date | Country | |
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61480735 | Apr 2011 | US | |
61377765 | Aug 2010 | US |