The present invention relates to a steerable catheter with portions of different stiffness, having: a proximal end, a distal end, a lumen extending there between, at least one magnet at the proximal end, at least a magnetic field to influence the proximal end, wherein portions of the steerable catheter can be of different stiffness.
Such a catheter having the features mentioned above is known from WO 01/17600 A1.
Another prior art catheter is US 2008/009831 A, wherein the catheter assembly includes an elongate shaft comprising a thermoplastic polymer such as a thermoplastic shape memory polymer having a pre-selected glass transition temperature (Tg) and a means for heating the thermoplastic polymer, wherein the thermoplastic polymer is in a rubbery state at temperatures above the glass transition temperature and is in a glassy state at temperatures below the glass transition temperature. The elongate shaft may be selectively heated and cooled to provide sufficient flexibility and retention during a medical procedure. [0033] of US 2008/009831 A names a number of possibilities how to heat and cool the shape memory polymer.
Remote magnetic navigation of catheters is a technique to used to perform radiofrequencey ablation of heart tissue in order to treat—inter alia—cardiac arrhythmias. The flexible magnetic catheter as mentioned above can be, in some cases, not dexterous enough to navigate the complex and patient-specific anatomy of the heart.
Based on the above prior art it is an object of the invention to provide a steerable catheter with portions of different stiffness having improved steering functions.
The present invention provides a steerable catheter with portions of different stiffness, having: a proximal end, a distal end, a lumen extending there between, at least one magnet at the distal end, at least a magnetic field to influence the distal end, wherein portions of the steerable catheter can be of different stiffness, which is characterized in that the portions of different stiffness are in fact portions of variable stiffness based on a phase change between a liquid phase and a solid phase of a liquid-solid material in a at least partly double walled catheter providing a cavity for this liquid-solid material and having additional control elements configured to influence the phase of the liquid-solid material.
In one embodiment the liquid-solid phase transition is based on heating or cooling off the liquid-solid material. The liquid-solid phase transition can be based on heating or cooling off the liquid-solid material. The control elements can comprise a resistive wire heating coil.
The control elements can also comprise direct heating through electrodes provided across the catheter, either between two positions in the longitudinal direction axis or radially between the inner side of the outer flexible tube and the outer side of the inner flexible tube.
The liquid-solid phase transition can also be based on heating or cooling off the liquid-solid material through peltier elements, provided in the walls, preferably in the inner walls of the cavity for the liquid-solid material.
Further embodiments of the invention are laid down in the dependent claims.
During an ablation procedure multiple catheters are used and remote magnetic navigation can only control a single catheter. With the present catheter, it is possible to first move a reference catheter to a target position and subsequently move an ablation catheter to the ablation spot.
The magnet in the catheter can also be an electromagnet.
Preferred embodiments of the invention are described in the following with reference to the drawings, which are for the purpose of illustrating the present preferred embodiments of the invention and not for the purpose of limiting the same. In the drawings,
The magnet 20 is a permanent magnet.
In other embodiments, there might be only one such variable stiffness section 100 or more than two. Such variable stiffness sections 100, 105 can be separated by shaft sections. It is also possible to provide the magnet 20 as a plurality of magnet parts and extending the variable stiffness section 100 longitudinally into magnet area.
On the other side, the tip 11 can comprise a functional element like a radiofrequeny ablation unit as known from the prior art.
Identical reference numerals are used throughout all drawings for identical features.
On the left side of
The representation in the middle of
Finally, the representation on the right side shows a further evaluation of the situation of
The three representations of the catheter in three subsequent adjustments can be summarized in a table as:
“Remain” has the meaning that the direction of the magnetic field of the previous step is maintained. Then, it is noted that the steps 2 and 3 can be rotated, since, if there is no magnetic field (“remain”=no magnetic field remains), the second section can become flexible and then the magnetic field is activated with the direction 25 providing the bending of the second portion at this point in time. Rotating the steps 5 and 6 will result in a small bending of 1st portion to reduce a none perfect alignment between magnet and magnetic field during step 3,
Within the lumen for the variable stiffness material 201 are provided two helical portions of resistive wires 205 which are provided as two separate coils separated in the longitudinal direction of the catheter at the inner side of the outer flexible film 206. The resistive wires 205 are connected with the exterior, the power supply and the control unit delivering the heating current via two wires which are not represented in
Within the lumen for the variable stiffness material 201 are provided several temperature sensors 203 which are provided at two separate positions separated in the longitudinal direction of the catheter at the outer side of the inner flexible film 207. Thus they take the temperature of the variable stiffness material 201. The temperature sensors 203 are connected with the exterior and the control unit receiving the measurements signals via wires which are not represented in
Inside the inner flexible film 207 is the inner lumen 208, extending from the outside through the entire catheter until the rear wall 209 of the tip 11. Inside this lumen 208 is provided wires 202 to the tip which are lodged in the rear wall 209. The wires 202 can be connected in the tip to an ablation RF transmitter or electrodes to record cardiac activity. Inside this lumen 208 is also provided a lumen 204 for a cooling fluid. This lumen 204 is built by a further pipe inside lumen 208 and extending through the rear wall 209. Then cooling fluid can be provided from the outside through the lumen 204 to cool all elements outside from the flexible wall 207 and exits later on the lumen 208 into the hollow tip cavity 14 and exits through one of the irrigation holes 13 In the absence of a functional tip 11, this inner lumen 204 can be used as tool channel to introduce any interventional tool.
In this first embodiment the conducting wire 205 was wound around the variable stiffness material 201 in its rigid state and a current circulating through the copper wire 205 heats the variable stiffness material 201. The resistive wire 205 is split in two different parts providing the possibilities to activate none, the front, the back or both resistive wires 205. It is also possible to use more, i.e. a plurality of resistive wires.
The variable stiffness section 210 comprises two separate variable stiffness section 218 and 218′. They are separated by a thermal insulation torus or ring 215. On both sides of the thermal insulation torus 215 between the outer flexible material 207 and the inner flexible material 206 are provided one electrode 212 and 213, respectively. Near the magnet is provided the ring-shaped electrode 211 and on the shaft material 112 is provided the ring-shaped electrode 214. The electrode 211 is associated with the electrode 212 and the electrode 213 is associated with the electrode 214. Then the current flows in the longitudinal direction between the associated rings and heats the variable stiffness material 201. There are provided temperature sensors, but they are not shown in the
In all embodiments, the plurality of variable stiffness sections 100, 105, 218, 218′ can be separated by a heat isolating segment as element 215 to reduce the heat transfer between the variable stiffness sections.
The arrangement of the catheter cross section can be adapted to the application requirements as shown in
Additional lumens 208 and/or 204 can also be used as a channel for inserting a tool or wire for the catheter tip. Wires can also be integrated directly inside the variable stiffness material to provide power or signal transmission to the catheter tip. For example for radio frequency ablation we can integrate some wires for the ablation tip and one channel for delivering a fluid for ablation tip cooling which is expelled through the irrigation holes 13.
The temperature of the low melting point material can be monitored directly by measuring the electrical resistance in circuit 350 of the low melting point alloys or indirectly by measuring the resistance of the wire used for resistive heating. The change of resistance can then be fed to a control unit 310 that can keep the resistance around a set point and control the current flowing through the variable stiffness segment. The resistance corresponding to the phase change can be calibrated using resistance measurements during variable stiffness material cool down. The resistance measurements in the heating wire will show a plateau during the phase change as the temperature stays constant during phase changes. A simple implementation of a controller is to maintain the resistance slightly above the phase change resistance to keep the catheter in the flexible state or slightly lower to maintain it into the solid and rigid state. It is also possible to control it to any intermediate value to change continuously the stiffness of the catheter.
The melting temperature 510 shows that less energy dissipation leads to a shorter section 520 with a temperature higher than the melting temperature 510, i.e. the length where the curve 525 reflects a higher temperature than the melting temperature 510.
The melting temperature 510 shows on the other side that higher energy dissipation leads to a longer section 530 with a temperature higher than the melting temperature 510, i.e. the length where the curve 535 reflects a higher temperature than the melting temperature 510.
Providing more heat as energy dissipates will increase the length of the melted segment by heat conduction or convection along the variable stiffness core. In the opposite providing less energy as dissipated will result in a decrease of the melted length of the segment. This results in a continuous change of stiffness relative to the energy injected.
Temperature control can also be implemented by integrating temperature sensors into the catheter. This temperature can be fed to the controller to regulate the current.
The variable stiffness material 201 can be an LMPA (low melting point alloy). Such an LMPA or fusible alloy are metal alloys that can be melted at relatively low temperature (in general below 183° Celsius). Those alloys are composed of a mixture of Bismuth, Lead, Tin, Indium, Cadmium, Thallium, and Gallium. Some of the most common low melting point alloys are commercially obtainable Rose's metal, Cerrosafe, Wood's metal, Cerrolow 136 and Cerrolow 117.
An alternative to low melting point alloys is to use a low melting point polymer as disclosed in H. Dong and G. M. Walker, “Adjustable stiffness tubes via thermal modulation of a low melting point polymer,” Smart Mater. Struct., vol. 21, no. 4, p. 42001, April 2012. It is also possible to use waxes as disclosed in N. G. Cheng, A. Gopinath, L. Wang, K. Iagnemma, and A. E. Hosoi, “Thermally Tunable, Self-Healing Composites for Soft Robotic Applications,” Macromol. Mater. Eng., vol. 299, no. 11, pp. 1279-1284, November 2014. Furthmore, any material with a large change of stiffness in a temperature range between 20° C. and 150° C. can be used as disclosed in M. Manti, V. Cacucciolo, and M, Cianchetti, “Stiffening in Soft Robotics: A Review of the State of the Art,” IEEE Robot. Automr. Mag., vol. 23, no. 3, pp. 93-106, September 2016.
The variable stiffness material and heating mechanism can be replaced by any stiffening mechanism or combination of them (i.e. fluidics, tendons, electro active polymers, SMA, braided sleeve, flexible layer, granular jamming, layer jamming, electro-magneto-rheological material, glass transition material, shape memory materials, conductive polymer or chemical based).
Depending of the design and the application the variable stiffness segment 100 etc. can have an external diameter between 0.5 mm and 20 mm. The length of the device can vary in function of the operating site going from 2 mm (i.e. eye catheter) to long device 8m (i.e. small intestine). For a long device only the first 300 mm need to have combined magnetic field steering and controlled of the stiffness.
In the flexible state the variable stiffness segment should be able to bend at less 450 with a magnetic field of 250 mT.
Number | Date | Country | Kind |
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17189490.0 | Sep 2017 | EP | regional |
Filing Document | Filing Date | Country | Kind |
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PCT/EP2018/073326 | 8/30/2018 | WO | 00 |