Patent Application
20210196378
This invention relates to a catheter ablation device and a method of using such device. The device may be a microwave ablation device, with application in the field of endovascular sympathectomy or denervation such as renal artery denervation. The invention may also find application in other fields of medical ablation including the treatment of atrial and ventricular arrhythmias.
Hypertension is a significant medical condition that leads to morbidity and mortality from end organ injury, such as strokes, heart attack and kidney failure. Many patients require multiple medications for blood pressure control and, for some patients, medications are poorly tolerated or ineffective altogether. Renal artery denervation by radiofrequency catheter ablation has emerged as a possible treatment option to control hypertension in these patients who are refractory or intolerant of medical therapy. The procedure aims to eliminate the efferent and afferent nerves that relay neural messages between the kidneys and the central nervous system, as these form essential components of neuro-hormonal reflexes that elevate blood pressure. The efferent and afferent nerves travel in the outer layer (i.e. adventitia) of the renal artery and the perinephric fat, mostly between 1 and 6 mm from the inner (luminal) surface of the renal arteries, and these nerves can potentially be destroyed by endovascular catheter ablation.
More recently, microwave ablation techniques have been proposed for vascular denervation, and the inventors of the present inventions have demonstrated very effective outcomes in trials of a microwave ablation device as described in WO2016/197206, the entire contents of which are included herein by reference.
Development of this concept has confirmed that microwave ablation using endovascular catheters has applications for renal denervation in the treatment of hypertension as well as cardiac ablation in the treatment of arrhythmias. Microwave heating is radiant and can penetrate deeply into tissue, creating large thermal lesions of more uniform temperature distribution than radiofrequency ablation. The technique does not require any catheter tip-to-tissue contact to produce heating.
Any discussion of documents, acts, materials, devices, articles and the like in this specification is included solely for the purpose of providing a context for the present invention. It is not suggested or represented that any of these matters formed part of the prior art base or were common general knowledge in the field relevant to the present invention as it existed in Australia or elsewhere before the priority date of each claim of this application.
In one form, the present invention provides a catheter ablation device for delivery of energy to a selected region of tissue, the device having an antenna portion including a radiating antenna electrically connectable via an electrical feedline to a source of energy, the antenna configured to generate an electromagnetic field able to ablate tissue in said selected region of tissue, the device including a thermocouple having a hot junction formed by electrical connection between a thermocouple conductor and a conducting part of the electrical feedline.
In this way, it is not necessary to realize the thermocouple by way of a dedicated thermocouple conductor pair, as the second conductor of the thermocouple is provided by the feedline used to supply the ablation energy to the device antenna.
Preferably, the device is a microwave ablation device for delivery of microwave energy, the source of energy comprising a microwave generator, and the conducting part of the electrical feedline is the shield braid of a coaxial microwave feedline.
Preferably, the hot junction electrical connection point is at or close to the location where the electrical feedline connects to the radiating antenna.
Preferably, the thermocouple conductor and the conducting part of the electrical feedline are electrically connected to a thermocouple temperature monitoring means, configured to provide an indication to a user of the device of the temperature in said antenna portion.
Said thermocouple conductor may be provided by a thermocouple wire such as a constantan wire. Preferably, the catheter ablation device comprises an elongated catheter having an outer sheath, the wire running from a proximal portion of the catheter within said catheter sheath to the hot junction electrical connection.
In one form, the thermocouple wire is arranged as a pull wire, such that its manipulation from a proximal portion of the catheter results in selective manipulation of the catheter at said antenna portion, the hot junction electrical connection providing a point of mechanical connection between the pull wire and the electrical feedline to enable said manipulation.
In this form, the device may include a flexion structure at or adjacent to a distal end of the electrical feedline, the pull wire arranged to cause or permit bending of said flexion structure when traction is applied thereto, to result in maneuvering of said antenna portion.
The flexion structure may comprise a sleeve arranged around the electrical feedline having one or more compressible elements configured in a directional arrangement, the wire running within said sleeve, such that traction of the pull wire results in directional compression of the sleeve and thus directional maneuvering of the antenna portion.
The wire is preferably accommodated within the catheter sheath in a manner to retain it relatively close to the electrical feedline from a proximal portion of the catheter to the hot junction electrical connection.
Embodiments of the invention therefore improve the efficacy and safety of ablation procedures.
Illustrative embodiments of the various aspects of the present invention will now be described by way of non-limiting example only, with reference to the accompanying drawings. In the drawings:
In
The various components of device 10 and of artery 12 and surrounding nerves are set out in further detail in WO2016/197206. Other features, including optional components, materials, dimensions, functions, procedural steps and operational parameters are also discussed in that publication.
Of particular note in the context of the present invention are the following components:
Device 10 may include additional components and functionality, as understood by the skilled person, including those discussed in WO2016/197206.
At the proximal end of patient cable 52, fluid line 54 connects to a fluid control system 56, which provides the saline irrigation flow though sheath 46, while patient cable feedline 22′ connects to an electrical power/control unit 60. Fluid control system 56 includes suitable pump, control and flow measurement means, allowing selective adjustment of fluid flow parameters, and may also be used to introduce other fluids such as drugs and markers into the fluid flow for delivery to the distal end of the catheter device. Electrical unit 60 includes a tunable microwave generating source for delivering power to antenna 34. Electrical cabling 58 provides connection of other electrical components of device 10 (as discussed below) to power, monitoring and control circuitry comprised in electrical unit 60. As will be appreciated, patient cable 52 jackets together all the cores from handle H, for convenient implementation of the device.
Device 10 also includes a means for measuring the temperature of the distal portion of the catheter.
It is known to include in medical catheter devices one or more temperature sensors, such as thermocouples or thermistors. For example, for temperature monitoring using a thermocouple, a catheter is provided with a thermocouple wire pair of two different metals extending from the proximal end, through the catheter shaft and into the distal portion, where the thermocouple hot junction of the wire pair (the temperature measuring point) is located. The ends of each wire are typically stripped of their covering insulation, twisted, soldered and potted into a distal tip electrode. However, particular issues arise with regard to use of this type of device in microwave ablation devices
As will be understood from WO2016/197206, microwave heating is radiant and can penetrate deeply into tissue without antenna-tissue contact. The design of the catheter means the radiating antenna is both electrically insulated from the surrounding environment and separated therefrom by a zone of flowing irrigation fluid (saline). This prevents temperature rises at the catheter tip due to ohmic heating and reduces any dielectric heating along the catheter shank, thus enabling higher microwave power to be used without undesirably or uncontrollably high temperatures within the catheter. In this regard, the temperature of the catheter tip should be restricted to a maximum of around 50° C., as above this temperature there are risks of coagulum formation, tissue charring and steam pops, which can cause adverse clinical outcomes. Monitoring temperature in the distal portion of the catheter can therefore be important. Additionally, during microwave renal artery denervation, a temperature sensor in the vicinity of the catheter tip can provide a measure of renal artery blood flow velocity using a thermodilution method. This enables monitoring of arterial patency, required for safe delivery of microwave energy, as well as reduction in renal microvascular resistance, expected to occur with successful renal denervation if the patient has a high renal sympathetic tone (due to innate physiology or otherwise).
A natural consequence of the electrical isolation and fluid surrounding the microwave antenna is the inability to approximate the local tissue temperature by measuring the temperature of the antenna tip.
As illustrated in
Importantly, this arrangement obviates the need for a second wire (and associated elements such as adhesive) in order to provide the thermocouple. The temperature measurement is taken of the outer shield material itself, close to or at the point where the braid ends, from which the central feedline core extends.
In particular, the hot junction is made by stripping the insulation from the end of the constantan wire, and soldering it to a short end portion 106 (see further detail in
Wire 100 runs along the length of the catheter and connects via a suitable connector in handle H to patient cable 52 and from there through electrical cabling 58 to electrical power/control unit 60, which includes appropriate circuitry and processing means to calculate the temperature from the measured voltages. In the figures, reference 150 indicates the guiding sheath through which catheter device 10 is introduced.
This thermocouple system provides a means of monitoring heating adjacent to the catheter antenna, in particular to enable the user to avoid excessive temperatures during ablation, such as may result from excessively high power or failure of catheter irrigation flow. Further, monitoring temperature provides a measure of the microwave radiation at the antenna. With higher electrical power reaching the antenna, or as frequency matching between the antenna and its surrounding medium improves, the local temperature increases. Thus the temperature provides an independent measure of microwave emission, additional to measuring reflected power at the microwave generating source.
By way of example, in testing the device of the invention an ablation procedure under deliberately suboptimal conditions was conducted by applying 80 W of microwave power with 10 W of reflected power measured at the generator, this being a result of choosing a poorly matched frequency. With the thermocouple system a temperature at point 108 of 38° C. was measured. Repeating the test with the same forward power and selection of an optimal frequency (reducing the reflected power measured at the generator to zero), a temperature of 44° C. was measured.
As noted above, the temperature at the feedline braid point 108 during ablation correlates with microwave emission from the antenna. Testing of the device also demonstrated an inverse relationship between the reflected power detected by the microwave generator and the measured temperature, providing an additional independent measure of microwave energy emission.
In accordance with a further embodiment of the invention, the thermocouple wire can be used to serve the double function of temperature monitoring and catheter steering. The detail shown in
To this end, a part of the microwave feedline 22 is provided with a flexion sheath 102, made from a relatively non-compressible material. Flexion sheath 102 encases the feedline from a point 108 at the proximal end of antenna 34 (at the termination of conductive shield 28) to a point 104 where it is anchored to outer sheath 26 of the feedline, a distance of for example 30 mm, defining the longitudinal extent of the desired flexion portion of the catheter. The inner diameter of flexion sheath 102 is larger than the outer diameter of feedline sheath 26, to provide room to accommodate thermocouple wire 100 for longitudinal movement, as discussed below.
Flexion sheath 102 includes along its length on one side a series of regularly spaced flexible striations 103, which may be transverse cuts in the material, or may comprise a soft, flexible material intercalated along the length of the flexion section. In either form, these striations allow flexion sheath 102, on that side only, to readily compress (remaining resistant to compression on the opposite side). This arrangement therefore provides a mechanism comprising a relatively incompressible ‘spine’ and a compressible arrangement of ‘ribs’, flexion enabled in the direction opposite the spine.
From point 104, on the same side of the feedline 22, a hollow cable 101 of a relatively non-compressible material (to prevent compression in the axial direction, but generally able to deflect relatively easily in the lateral direction) runs to the proximal part of the catheter, secured to the outer feedline sheath 26 by jacketing within the feedline, or alternatively secured within a lumen of the outer sheath 46. The internal bore of cable 101 is sized to accommodate thermocouple wire 100, and this arrangement ensures the wire is retained close to the feedline core of the catheter.
As
Wire 100 thus provides a pull wire function, as known in the general field of deflecting tip catheters. When wire 100 is pulled in direction A, the wire length 110 along this flexion portion shortens, producing flexion of sheath 102 by closing or compressing of the striations 103 and resulting in the bending shown in
When wire 100 is released, the natural elasticity of the materials of the catheter results in a return to the original, straight configuration. As will be appreciated, the wire is always retained parallel to the axial direction of the catheter along its length, so minimizing the risk of the wire fatiguing at any point.
In this way, the tip of the catheter can be steered by manipulation of thermocouple wire 100, so guiding the catheter into the desired ablation position, without the need to incorporate a separate pull wire in the catheter assembly.
Alternative means of providing the desired directional flexibility of the catheter are of course possible, such as use of a coil-reinforced outer sheath, and/or use of a strip of stainless steel (or similar relatively incompressible material) to provide the spine of the flexion portion, the remainder of this portion of the catheter being of an elastomeric material able to compress as required, the catheter thus able to flex in a direction opposite to the location of the spine.
The referenced points and phases of the procedure are:
As noted above, and as
The referenced points and phases of the process are:
Microwave heating is radiant and can penetrate deeply into tissue, so catheter devices of the type described in WO2016/197206 can perform deep circumferential ablation with sparing of injury to tissue adjacent to the flowing blood pool.
During microwave renal denervation procedures it is important to be able to monitor renal arterial calibre. Reductions in renal arterial calibre increase the risk of thermal arterial injury, as the arterial wall is brought closer to the microwave antenna and is thus exposed to more rapid heating, while the vascular contraction can result in a reduced arterial blood flow and thus a reduced rate of cooling. On the other hand, renal arterial dilatation can provide evidence of successful renal nerve ablation and provide a physiological endpoint to ensure effective therapy delivery.
The inventors have determined that monitoring the impedance of the blood pool around the microwave ablation catheter device 10 can provide a measure of vascular calibre. While impedance monitoring is known in cardiovascular procedures, this is generally for measuring changes in tissue impedance as the tissue heats.
As shown in
Wires 200 and 202 connect via suitable connectors in handle H to patient cable 52 and from there through electrical cabling 58 to electrical power/control unit 60, which includes appropriate circuitry and processing means to measure, record and provide display of the impedance between electrodes 204 and 206.
Once an alternating electrical potential is applied to wires 200 and 202, with the catheter within the blood pool and the saline irrigation fluid filling the catheter distal portion, an ionic conductivity path 210 is formed from electrode 206, along the inside of the catheter in the fluid volume surrounding feedline 22 and radiator 24, through one or more of the six slit orifices 50, and back along the outside of the catheter in the blood to electrode 204. Measuring the current flow thus provides a measure of the impedance between electrodes 204 and 206, namely the impedance of the saline volume and the blood volume through which the electrical path passes, and changes in this impedance can provide an indication of changes in the vessel calibre. As will be understood, as artery 12 expands during a denervation procedure, the electrical characteristics of the part of the electric circuit inside the catheter do not substantially change, but the lower resistive path of the part of the circuit outside the catheter has a noticeable effect on the overall impedance.
Hence, it is necessary that external electrode 204 is in the blood flow, and
In
In an alternative form, external electrode 204 may be provided in a manner independent of device 10. For example, it may be disposed at or near the distal end of guiding sheath 150 (for example, adjacent to the position where a radiopaque ring is commonly located), or it may be provided as a reference patient return electrode at a suitable location. Generally, such solutions are not the preferable approach, as they necessitate use of a separate electrical connection lead to the impedance measuring circuitry of electrical power/control unit 60. However, such an arrangement can have the advantage of reducing and simplifying the componentry of device 10, so minimizing the calibre of the catheter sheath 46.
As will be understood, it is important to terminate wires 200 and 202 before the radiator portion of the catheter, to ensure any metal components are positioned outside the microwave field and to avoid interference on both the field application and the impedance circuit that would otherwise result. Further, ring electrodes 204 and 206 are preferably not complete conducting rings, i.e. are preferably C-shaped rather than O-shaped, to avoid closing the electrical path, potentially rendering them parasitic inductors in the microwave field, which could lead to unwanted heating.
The alternative electrode arrangement in
During their course along the outside of feedline sheath 26, wires 200, 202 may be secured thereto by glue joints or bands of heat shrink.
In a further embodiment of the present invention, the inventors developed and tested an alternative version of catheter 10 in which wires 200, 202 were integrated within the wall material of catheter sheath 46 at fabrication, thus wholly electrically insulated from the inside or outside of the sheath. In this version, electrodes 204 and 206 were formed as incomplete ring structures (of similar form to those of the embodiment shown in
One advantage of providing both electrodes on the catheter sheath 46 is to ensure the intervening distance is functionally constant, regardless of any relative movement of the feedline within, thus avoiding any associated measurement artefact.
The concept of monitoring vascular dilatation using an impedance circuit in a denervation catheter was tested by the inventors in animal trials, the graphical output of impedance against time shown in
The referenced points and phases of the procedure are:
Impedance drop results from the heating effect of microwave radiation on the fluid, but impedance increases with increased rates of irrigation due to the cooling effect of room temperature saline. From the start of the microwave ablation at the end of phase A″ the impedance drops for around 30 s, due to the warming of the saline around the microwave radiator.
At about 72 s the injection of cold contrast media causes the steep transient in measured impedance to point C″, where the first angiogram is taken.
At this point, balloon occlusion of the suprarenal descending aorta (balloon occlusion device 210 shown in
The second angiogram corresponds to point E″ in
In this example, an impedance change of approximately 250 ohms was observed, with a reduction of vessel calibre from approximately 6 mm to 5 mm.
This experiment clearly demonstrates the value of impedance monitoring as a measure of vascular calibre, and hence its value as a feedback mechanism in vascular denervation therapy.
In addition to providing an indication of the points and phases in the procedure discussed above, the invention can provide an indication of deployment of the locating formation(s) 48, provided the fluid path traverses the position of a formation. Once a locating formation is deployed, then any observed change in impedance should be due solely to vascular calibre change. But during deployment the impedance is sensitive to the distension of the locating formation, and the invention can thus be used to confirm successful deployment.
It will be understood that the invention disclosed and defined in this specification extends to all alternative combinations of two or more of the individual features mentioned or evident from the text or drawings. All of these different combinations constitute various alternative aspects of the invention.
As used herein, except where the context requires otherwise, the term “comprise” and variations of the term, such as “comprising”, “comprises” and “comprised”, are not intended to exclude further additives, components, integers or steps.
| Number | Date | Country | Kind |
|---|---|---|---|
| 2018902956 | Aug 2018 | AU | national |
This application claims priority to and is a continuation of International Patent Application No. PCT/AU2019/050846, filed Aug. 13, 2019; which claims priority from AU Patent Application No. 2018902956, filed Aug. 13, 2018. The entire contents of each of the PCT/AU2019/050846 and AU 2018902956 applications are hereby incorporated by reference in their entirety for all purposes.
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/AU2019/050846 | Aug 2019 | US |
| Child | 17171878 | US |
