CATHETER AND METHOD FOR CONTROLLING THE CATHETER
20240041532 ยท 2024-02-08
Inventors
Cpc classification
A61M25/0158
HUMAN NECESSITIES
A61B34/20
HUMAN NECESSITIES
A61B2034/102
HUMAN NECESSITIES
A61B2090/3983
HUMAN NECESSITIES
International classification
Abstract
A catheter and a method for controlling the catheter, wherein the catheter has a tip, optionally comprising a working channel extending through the tip of the catheter, a set of coils surrounding the tip, and power wires arranged to supply the set of coils with electrical energy, wherein the set of coils comprises four side coils arranged around the tip such that a straight line standing orthogonal on a longitudinal direction of the tip crosses a center of the respective side coil.
Claims
1. Catheter, optionally an endovascular catheter, wherein the catheter comprises: a tip, optionally comprising a working channel extending through the tip of the catheter, a set of coils surrounding the tip, and power wires arranged to supply the set of coils with electrical energy, wherein the set of coils comprises four side coils arranged around the tip such that a straight line standing orthogonal on a longitudinal direction of the tip crosses a center of the respective side coil.
2. Catheter according to claim 1, wherein: a first and a second one of the side coils are connected in series, a third and a fourth one of the side coils are connected in series, the first and the second one of the side coils are arranged on opposite sides of the tip, and the third and the fourth one of the side coils are arranged on opposite sides of the tip and in-between the first and the second one of the side coils.
3. Catheter according to claim 1, wherein a turn number of at least one of the four side coils is between 2 and 40, optionally 4 and 30, further optionally 7.
4. Catheter according to claim 1, wherein the set of coils comprises at least one axial coil arranged around the tip such that a straight line extending in parallel to the longitudinal direction of the tip crosses a center of the at least one axial coil.
5. Catheter according to claim 1, wherein at least one of the coils of the set of coils was manufactured using laser machining, laser lithography and/or manually wound.
6. Catheter according to claim 1, wherein at least one of the coils of the set of coils has, an optionally rectangular, Archimedean spiral coil design.
7. Catheter according to claim 1, wherein at least one of the coils of the set of coils has an in-plane design.
8. Catheter according to claim 1, wherein the four side coils are arranged on the same, optionally flexible, circuit board.
9. Method for controlling a movement of a catheter according to claim 1 in a magnetic field, wherein the method comprises: determining a torque that needs to be applied onto the catheter such that the catheter carries out the movement, determining a minimum current that needs to be supplied to each coil of the set of coils, respectively, to reach the determined torque by solving an optimization problem, and supplying the determined minimum current to each coil of the set of coils, respectively, such that the catheter carries out the movement.
10. Method according to claim 9, wherein the optimization problem is defined as follows:
11. Method according to claim 9, wherein determining the torque comprises solving a further optimization problem to minimize the torque to be applied onto the catheter such that the catheter carries out the movement.
12. Method according to claim 9, wherein the catheter comprises a flexible substantially rod-shaped portion and the movement comprises a deformation of said rod-shaped portion resulting in a movement of a tip of said rod-shaped portion.
13. Method according to claim 12, wherein solving the further optimization problem comprises: determining the deformation of said rod-shaped portion that is needed for the movement of the tip of said rod-shaped portion from an actual location to a desired location such that a torque that is required for the deformation of said rod-shaped portion is minimized, and determining the torque that needs to be applied onto the catheter such that the catheter carries out the movement to be equal to the torque that is required for the deformation of said rod-shaped portion.
14. Method according to claim 13, wherein the deformation that is needed for the movement of the tip of said rod-shaped portion from the actual location to the desired location is determined using a model, optionally a Cosserat model, depicting the nonlinear dynamics of said rod-shaped portion.
15. Method for controlling a movement of a catheter according to claim 1 in a magnetic field, wherein the method comprises: determining a torque that needs to be applied onto the catheter such that the catheter carries out the movement, wherein determining the torque that needs to be applied onto the catheter comprises solving an optimization problem to minimize the torque that needs to be applied onto the catheter such that the catheter carries out the movement, determining a current that needs to be supplied to the set of coils to reach the determined torque, and supplying the determined current to the set of coils such that the catheter carries out the movement.
16. Method according to claim 15, wherein the catheter comprises a flexible substantially rod-shaped portion and the movement comprises a deformation of said rod-shaped portion resulting in a movement of a tip of said rod-shaped portion.
17. Method according to claim 15, wherein solving the optimization problem comprises: determining the deformation of said rod-shaped portion that is needed for the movement of the tip of said rod-shaped portion from an actual location to a desired location such that a torque that is required for the deformation of said rod-shaped portion is minimized, and determining the torque that needs to be applied onto the catheter such that the catheter carries out the movement to be equal to the torque that is required for the deformation of said rod-shaped portion.
18. Method according to claim 17, wherein the deformation that is needed for the movement of the tip of said rod-shaped portion from the actual location to the desired location is determined using a model, optionally a Cosserat model, depicting the nonlinear dynamics of said rod-shaped portion.
19. Method according to claim 9, wherein the method comprises receiving user input with respect to the movement via a user interface, optionally comprising a joystick, of the catheter.
20. Method according to claim 9, wherein the method comprises: determining an actual position of the catheter, optionally the tip thereof, using medical imaging, and automated controlling of the movement based on the determined actual position.
21. Method according to claim 9, wherein the method comprises displaying an actual position of the catheter and/or a position of the catheter after carrying out the movement on a display device.
22. Method according to claim 21, wherein the method comprises displaying the actual position of the catheter and/or the position of the catheter after carrying out the movement with respect to a tissue, optionally of a human being or an animal, on the display device.
23. Method according to claim 9, wherein the magnetic field is produced by a medical imaging device, optionally a magnetic resonance imaging device.
24. Method according to claim 9, wherein the magnetic field is a static magnetic field.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DESCRIPTION OF EXEMPLARY EMBODIMENTS
[0096] As required, detailed embodiments are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the invention that may be embodied in various forms. The figures are not necessarily to scale, and some features may be exaggerated to show details of particular components. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present invention.
[0097] In the following a solution to the Lorentz force-induced heating concern without using active cooling or limiting microcoil activation times for steering of a medical device is described. This is accomplished using a heat-mitigated design and actuation strategy using the previously mentioned 44? C. as a heating threshold for safe navigation within the body (assuming no arterial flow; worst-case scenario).
[0098] In
[0099] The catheter 1 comprises a rod-shaped portion 3 and a tip 2 arranged at a distal end of the rod-shaped portion 3, wherein a set of coils 4 is arranged at the tip 2.
[0100] As can be gathered from
[0101] As in
[0102] The set of coils 4 comprises two axial coils 6 having a round cross section and which are arranged around the working channel 5, wherein a center of these two axial coils 6 is located on the X-axis, i.e., windings of the axial coils 6 are wound around the X-axis. In other words, a straight line extending in parallel to the longitudinal direction of the tip 2 crosses the center of the two axial coils 6. Therefore, in the intial position of the cathter 1 shown in
[0103] The set of coils 4 comprises four side coils 7-10 arranged around the two axial coils 6 of tip 2 such that a straight line standing orthogonal on the longitudinal direction of the tip 2, i.e., a straight line arranged in the YZ-plane and standing orthogonal on the X-axis, crosses a center of the respective side coil 7-10. Therefore, in the intial position of the cathter 1 shown in
[0104] All side coils 7-10 are arranged on the same flexible circuit board 14 which is wrapped around the axial coils 6, wherein a polymide layer 11 is arranged between the side coils 7-10 and the axial coils 6 (see
[0105] The Lorentz force that is generated by the side coils 7-10 leads to a movement of the tip 2 of the cathter 1 substantially in the YZ-plane, as shown in
[0106] When an angle of 90? is reached, i.e., when the rod-shaped portion 3 is bound to such an extent that the tip 2 magnetic field vector B.sub.0 and the center of side coils 7-10 are in parallel, no Lorentz force is generated by the side coils 7-10 and the axial coils 6 may be used to overcome this point.
[0107] A turn number of the four side coils 7-10 may be between 2 and 40 (i.e, including 2 and 40) or between 4 and 30 (i.e, including 4 and 30), respectively. However, in the present case the turn number the four side coils 7-10 is 7 (seven), respectively. Together with the rectangular Archimedean spiral, in plane coil design of the side coils 7-10, which are manufactured using laser machining, a very small tip 2 diameter may be reached, e.g., around 1 mm.
[0108] This will be explained in detail below with respect to one specific implementation of the dislcoure which is described solely for explanatory purposes and is not intended to limit the scope of the disclosure, especially the claims, in any way.
[0109] Lorentz-force actuators have proven to be effective for various robotic/medical applications due to their precision, high force output, and scalability for soft device integration. These actuators utilize external magnetic fields to generate a force directly controlled for robotic actuation. Therefore, Lorentz-force actuators can utilize the high external magnetic field such as generated in MRI environments to develop robotic devices.
[0110] It has been demonstrated integrating such actuators to catheters through the use of copper coils for Lorentz force-based steering in blood vessels and the heart. In this approach, controlling microcoil current polarity directly translates to a tip deflection of the tip 2 in the respective direction (se
T=m?B.sub.0i=NI(A?B.sub.0) (Equation 1)
which can be used to govern axial coil torque for a Lorentz force-actuated catheter with equally-sized coil loops. In terms of saddle (side) coil implementation, microcoils can be integrated to the catheter tip for additional degrees of freedom (DoF). Design optimization of an (e.g., MRI-driven) catheter 1 using a four coil configuration allowed for maximizing the achievable workspace (e.g., within the heart) given certain constraints such as the number of coil sets and current inputs.
[0111] However, maximizing the number of coil turns and area may not be feasible for navigating within narrow vasculature. In order to improve upon both existing design schemes, laser machining may be used in conjunction with the Archimedean spiral coil design to create an in-plane, quad-configuration, microcoil design shown in
[0112] The proposed design enables more compact and significantly smaller final catheter diameters, e.g., down to 1 mm, than previously proposed designs while achieving comparable steerability. In this approach, both saddle/side coil sets are integrated on the same circumferential plane without introducing additional layer thickness compared to the state of the art.
[0113] The governing equations for a rectangular Archimedean spiral are given below for estimating the microcoil's magnetic moment. The approximate effective area of all coil loops 7-10 can be expressed as (Equation 2)
and corresponding total wire length for estimating power consumption as (Equation 3)
[0114] Inserting Equation (2) into Equation (1) yields the magnetic momentof a single saddle coil
m=IA.sub.total
Achieving higher bending angles for Lorentz force-based actuation implies maximizing the coil's magnetic moment. As shown in the above equations, tuning various parameters (i.e.,coil turn number, current, catheter diameter) can influence the performance. Typically, a larger coil turn number implies better bending performance due to the increasing coil area. However, when power is constrained to the heating threshold (e.g., 0.5 W) to mitigate heating effects, an inverse relation exists between the magnetic moment and coil turn number. In other words, a lower coil turn number is ideal for mitigating heat but requires higher currents to generate such magnitudes of electromagnetic torque leading to undesirable heating within the power wires 13. However, using larger power wires 13 to mitigate heating increases flexural rigidity depending upon wire gauge and thus has undesirable effects on catheter steerability. Therefore, a microcoil turn number in the above description ranges, especially of approximately 7, may be used to maximize the magnetic moment while remaining within well-established current ratings for power wires 13 and an acceptable range of stiffness for (e.g., endovascular) catheters.
[0115] In the following a method for controlling a movement of the above described catheter 1 in a magnetic field is described in detail. A flow chart of the method is shown in
[0116] The catheter 1 comprises a flexible substantially rod-shaped portion 3. The movement of the tip 2 comprises a deformation of said rod-shaped portion 3 resulting in a movement of the tip 2, of said rod-shaped portion 3.
[0117] In a first step Si of the method a torque that needs to be applied onto the catheter 1 such that the tip 2 of the catheter 1 carries out the movement is determined.
[0118] Determining the torque may comprise solving a first optimization problem to minimize the torque to be applied onto the catheter 1 such that the tip 2 of the catheter 1 carries out the movement.
[0119] Solving the first optimization problem may comprise determining the deformation of said rod-shaped portion 3 that is needed for the movement of the tip 2 of said rod-shaped portion 3 from an actual location to a desired location such that a torque that is required for the deformation of said rod-shaped portion 3 is minimized. The torque that needs to be applied onto the catheter 1 such that the catheter 1 carries out the movement is then set to be equal to the torque that is required for the deformation of said rod-shaped portion 3.
[0120] The deformation that is needed for the movement of the tip 2 of said rod-shaped portion 3 from the actual location to the desired location may be determined using a model, optionally a Cosserat model, depicting the nonlinear dynamics of said rod-shaped portion 3.
[0121] This will be explained in detail below with respect to one specific implementation of the disclosure which is described solely for explanatory purposes and is not intended to limit the scope of the disclosure, especially the claims, in any way.
[0122] Steerable catheters undergo large deformations/motions during surgical procedures. One method of modeling such motions commonly used to model elastic rods and continuum rods is the Cosserat rod theory. The Cosserat rod model integrates the traditional bending and twisting of Kirchhoff rods with additional stretching and shearing to capture full beam dynamics. The Cosserat model accurately depicts the nonlinear dynamics of elastic rods with different materials and geometries. The catheter 1 may be modeled as a cantilever beam undergoing an external torque and tip force. The state of the catheter may be described using a set of N discretized segments Y=[y.sub.0.sup.T,y.sub.1.sup.T, . . . ,y.sub.n.sup.T].sub.N.sup.T. The discretized state vector for each segment i contains segment position (p.sub.i?.sup.3), orientation (R.sub.i?SO(3)), extension force (n?
.sup.3), and shear torque (m?
.sup.3), which can be expressed in one vector y.sub.i=[p.sub.i, R.sub.i, n.sub.i, m.sub.i]. The rotation matrix is defined in the (e.g., MRI's) fixed coordinate frame, along with two additional coordinate frames L; control frame C representing the catheter free length starting position and tip frame T locating the start of the microcoils. Therefore, a system of nonlinear ordinary differential equations (ODEs) can be expressed as (Equations 5 to 8)
where v and u are tangent and curvature vectors defined as, v={circumflex over (z)}+K.sub.1R.sup.Tn and u=K.sub.2R.sup.Tm m, wherez .sub.i is the unit vector in local coordinate frame, K.sub.1=diag(GA,GA,EA) and K.sub.2=diag(EI.sub.A, EI.sub.A,GJ). G, A, E, I.sub.A, and J represent the shear modulus, cross-sectional area, elastic modulus, area moment of inertia, and polar moment of inertia, respectively. Catheter forward kinematics, Y=f (n.sub.0, m.sub.0), can be calculated through numerical integration using fourth order Runge-Kutta algorithm, given the catheter's initial conditions: R.sub.0=R.sub.C, p.sub.0=p.sub.C, n.sub.0=n.sub.C, m.sub.0=m.sub.C. Although the forward kinematic model in an initial value problem form is useful for simulating catheter motion given a base wrench, an inverse kinematic model is needed to determine the minimum catheter torque for reaching desired orientations. An inverse kinematic model in a boundary value problem (BVP) form may be formulated with the following boundary conditions: R.sub.0=R.sub.C, p.sub.0=p.sub.C, n.sub.?=0, m.sub.?=?.sub.des and R.sub.?=R.sub.des. Here, n.sub.? and m.sub.? are expressed as the magnetic wrench at the tip 2 of the catheter 1. Due to the negligible magnetic gradient pulling force acting on the catheter tip in comparison to the magnitude of a distributed Lorentz force, it is assumed there is only torque at the tip 2. Therefore, the inverse kinematic for desired tip torque (?.sub.des=IK(R.sub.des)) is calculated by solving the following optimization problem for tip torque (Equation 9)
where the box minus (: SO(3)?SO(3).fwdarw.
.sup.3) is the rotation difference operator based on the matrix logarithm defined in Lie algebra. Tip torque is ?.sub.des=m.sub.N. Optimization is solved in real-time using the iterative Levenberg-Marquardt method implemented in C++, where catheter forward kinematics is used as the shooting function. It is important to note that the
error may be essential for the stability of the solution for near singular values, and the quadratic on tip torque regularizes the cost function to eliminate inverse kinematic solutions with loops.
[0123] In a second step S2 of the method a minimum current that needs to be supplied to each coil 6, 7-10 of the set of coils 4, 17, to reach the determined torque (?_des) by solving a second optimization problem is determined, respectively.
[0124] This will be explained in detail below with respect to one specific implementation of the disclosure which is described solely for explanatory purposes and is not intended to limit the scope of the disclosure, especially the claims, in any way.
[0125] Microcoil-based heat generation can be reduced by optimally distributing current to the side and axial coils 6, 7-10. The tip orientation controller therefore comprises a two-stage optimization scheme: 1) inverse kinematics to determine torque using Equation (9), and 2) saddle/axial coil current distribution. A power-optimized current distribution problem is formulated as a non-linear quadratic optimization (Equations 10 and 11)
where I=[I.sub.side,1, I.sub.side,2, I.sub.axial] represents the saddle/sie and axial coil currents,and ?.sub.coil represents the total torque generated by a saddle and axial coilset 6, 7-10, respectively. The first term of the costfunction is for consistency between desired tip torque and total coil torque, and second term is the coil power consumption cost, where R=diag(R.sub.side,1, R.sub.side,2, R.sub.axial] is the resistance of the coils. Due to the difference in magnitude between torque error and induced currents, an a constant is incorporated (determined using a grid search to find the best fitting; 1?10?6). This optimization is also solved using the Levenberg-Marquardt method. A comparison between actuating coils using equally-distributed power versus the optimal approach is shown in
[0126] In a third step S3 of the method the determined minimum current (I_side1, I_side2, I_axial) is supplied to each coil of the set of coils 6, 7-10, respectively, such that the tip 2 of the catheter 1 carries out the movement.
[0127] In