Patent Application
20150289930
This application claims the benefit of priority under 35 U.S.C. ยง119(a) to Great Britain Patent Application No. 1406496.8, filed Apr. 10, 2014, which is incorporated by reference here in its entirety.
The present invention relates to apparatus and a method for occluding or closing a vessel by means of RF embolization.
There are numerous medical conditions when it is desired or necessary to close a body vessel, including for instance in the treatment of aneurysms, arteriovenous malformations, arteriovenous fistulas, for starving organs of oxygen and nutrients for instance in the treatment or containment of cancerous growths, and so on.
Several techniques are known and in use for closing or occluding such body vessels. Traditionally, vessels have been closed by means of external ligation, which generally must be carried out by an open surgery procedure, with its associated risks, inconvenience and long patient recovery times. Other more recent methods aim to use an endoluminal procedure to insert into the vessel or organ one or more occlusion devices, such as a metal framed occluder, pellets or the like, able to obstruct the flow of blood in the vessel.
It is also known to seek to constrict a vessel by endoluminal ablation, causing contraction of the vessel and/or coagulation of blood to form a blood clot in the vessel. A technique which has been considered suitable is RF ablation, in which an electrical terminal is fed endoluminally into the vessel and an electrical pulse at RF frequencies applied to the electrical terminal. The conductivity of blood and/or the vessel tissues causes localised heating. This heating can be used to cause damage to the tissue (intima) of the vessel wall, resulting in vessel contraction. In other devices RF ablation heats the surrounding blood, causing this to coagulate around the electrical terminal and form a blood clot which blocks the vessel.
Two types of RF ablation apparatus are generally contemplated in the art, the first being a monopolar system having an elongate anode terminal and a cathode pad. The anode terminal is designed to be fed endoluminally into the patient's vessel, while the cathode pad is positioned against the person's outer body, as close as practicable to the anode terminal. Electrical energy applied to the anode terminal will pass by conduction through the patient to the cathode pad. There will be localised heating at the anode terminal, which effects the desired ablation.
A problem with monopolar systems is that it can be difficult to control the extent of damage to surrounding tissues and organs, as well as to the vessel wall. This risks damaging the vessel to the point of rupture, as well as possible irreversible damage to neighbouring organs.
Another RF ablation system uses a bipolar arrangement, in which an elongate electrical element includes both the anode and cathode terminals, which are spaced longitudinally from one another at a distal end of the electrical element. Current passes between the anode and the cathode terminals through the surrounding blood, causing localised heating and coagulation of the blood. A bipolar system has been considered to provide more localised heating and therefore reduced risk of damage to surrounding organs and tissue.
A problem particularly with a bipolar system, but also experienced in a monopolar system, lies with the retraction of the electrical terminal from the vessel at the end of the ablation process. In a system which ablates the vessel wall to cause its contraction, the electrical terminal can become attached to the vessel wall tissue, with the risk of tearing and rupturing the vessel wall. In a system which ablates the surrounding blood to generate a blood clot in the vessel, there is the risk that the blood clot is dragged with the electrical element and that the occlusion of the vessel is as a consequence lost. There is also the risk of leaving an opening in blood clot where the electrical terminal resided, which can result in incomplete occlusion and the risk of recanalization.
Some such devices have attempted to address the above problems by having an electrical element with a detachable terminal end. However, this entails leaving a foreign body in the patient.
Examples of prior art devices and methods can, for instance, be found in US-2009/0248007, US-2001/0020167, US-2001/0016739, U.S. Pat. No. 6,539,265, WO-2010/080974, U.S. Pat. No. 6,264,650, U.S. Pat. No. 6,066,139, U.S. Pat. No. 6,676,657, US-2010/0268217, U.S. Pat. No. 5,709,224, U.S. Pat. No. 6,398,779 U.S. Pat. No. 6,019,757 and U.S. Pat. No. 5,743,905.
The present invention seeks to provide improved apparatus for occluding or closing a body vessel.
According to an aspect of the present invention, there is provided apparatus for closing a blood vessel including: an elongate electrode element for being passed endoluminally to a treatment site and having at least one electrical terminal at a distal end thereof; a power supply for supplying energy to the electrode element; a detection unit for detecting at least one operational change at the at least one electrical terminal; a control unit connected to the power supply and to the detection unit; wherein the control unit is operable to control the power supply to supply energy to the electrode element at a first power level to cause a primary blood coagulation, to detect at least one operational change at the at least one electrical terminal and to control the power supply to supply energy to the electrode element at a second power level lower than the first power level to cause a secondary blood coagulation once the operational change has been detected.
The apparatus disclosed herein provides for closing any opening or lumen left by the retracting or retracted electrical element, namely by applying energy through the electrical element, at a power level less than the initial ablation power, which has the effect of causing secondary blood coagulation. Preferably, the second power level is insufficient to cause the creation of a further vessel occluding barrier, that is a second barrier which closes off the vessel in its entirety. Specifically, the application of the power at the second level stops once sufficient blood has coagulated to close any aperture left by the retracted or retracting electrical element. The occluding barrier created by application of power at the first power level will therefore form the total length of effective vessel occlusion, thereby making the method also suitable in vessel zones having short treatment sites, such as in locations with adjacent vessel side branches and the like.
Preferably, the apparatus includes a user notification unit coupled to the control unit, the control unit being operable to generate a notification on detection of the operational change in the at least one electrical terminal. The notification unit could be a visual notification, an acoustic notification, a vibratory notification, a combination of any of these, or any other suitable notification.
Preferably, the control unit is operable to command a partial retraction of the electrode element in a proximal direction on detection of the operational change. Partial retraction may leave a part of the electrode tip within the formed clot, thereby to keep any aperture therein closed and to ensure that the second phase of ablation takes place within the blood clot and able to close off the residual lumen.
In an embodiment, the apparatus may include a positioning, or drive, unit coupled to the control unit, the positioning unit being operable to effect the partial retraction of the electrode element in the proximal direction on detection of the operational change. The control unit may be operable to generate a notification to effect said partial retraction of the electrode element.
There may be provided an electrode position sensor coupled to the control unit, wherein the control unit is operable to control the power supply to supply energy to the electrode element at the or a second power level lower than the first power level when partial retraction of the electrode element has been detected.
In some embodiments the control unit may be operable to command the power supply to supply power to the electrode element until the electrode element has been retracted by a predetermined distance. The predetermined distance may be equivalent to a desired length of closure of the vessel. In other words, the system of this embodiment is able to create an occluding barrier of varying length.
The operational change preferably includes at least one of: change in measured impedance and change in temperature.
There may be provided a temperature sensor at the distal end of the electrode element.
In an embodiment, the electrode element includes an anode terminal, the apparatus including a cathode pad. In other words, the system may be a monopolar system.
In another embodiment, the electrode element includes anode and cathode terminals. In other words, the system may be a bipolar system.
According to another aspect of the present invention, there is provided apparatus for closing a blood vessel including: an elongate electrode element having at least one electrical terminal at a distal end thereof; a power supply for supplying energy to the electrode element; a detection unit for detecting at least one operational change at the at least one electrical terminal; a position sensor arranged to detect the position of the distal end of the electrode in a patient; a control unit connected to the power supply, to the detection unit and to the position sensor; wherein the control unit is operable to control the power supply to supply energy to the electrode element at a first power level, to determine movement of the electrode and to apply power to the electrode when the electrode has been deemed to have been moved by a first predetermined distance.
In this aspect, the system monitors for a change in the position of the electrode and applies ablation energy in a manner which can elongate the occlusive barrier which is produced.
In one embodiment, the control unit is operable to apply power to the electrical terminal continuously when in an initial position and while the electrode element is moved by the predetermined distance. In another embodiment, the control unit is operable to apply power to the electrical terminal discontinuously, when in an initial position and after the electrode element has been moved by the predetermined distance.
Preferably, the control unit is operable to apply power to the electrical terminal up to a second distance greater than the first predetermined distance. The second distance may be equivalent to a desired length of closure of the vessel.
Advantageously, the electrical terminal has a conductive length and the first predetermined distance is less than said conductive length.
In an embodiment, the control unit is operable to control the power supply to supply energy to the electrode element at a second power level lower than the first power level once the operational change has been detected. This is not essential though, and in other embodiments the control unit may be operable to apply power at the first power level or near the first power level so as to produce an occlusive barrier of radial dimensions at least as significant as that produced prior to movement of the electrode.
There may be provided a positioning unit coupled to the control unit, the positioning unit being operable to move the electrode element in at least a proximal direction. Such a positioning unit can therefore provide an automated ablation system.
There is also described herein a method of closing a blood vessel by means of apparatus including an elongate electrode element having at least one electrical terminal at a distal end thereof and a power supply for supplying energy to the electrode element; the method including the steps of: supplying energy to the electrode element at a first power level; detecting at least one operational change at the at least one electrical terminal; when said operational change has been detected supplying energy to the electrode element at a second power level lower than the first power level.
The method may include steps appropriate for effecting the functionality disclosed herein.
Other features of the apparatus and method disclosed herein will become apparent from the following specific description of preferred embodiments.
Embodiments of the present invention are described below, by way of example only, with reference to the accompanying drawings, in which:
There are described below various embodiments of apparatus and methods for effecting RF ablation of a body vessel, in particular a blood vessel. The preferred embodiments are designed to create blood clotting, that is to ablate the blood surrounding the electrical element. This can be achieved by selecting an ablation energy level and an ablation time duration suitable to heat surrounding blood, which in some circumstances can be expected to be less than the energy required to ablate the vessel tunica, although there may be experienced some contraction of the vessel as a result of the heating of the blood. The skilled person will be able to determine suitable ablation parameters from common general knowledge in the art. Moreover, the preferred embodiment uses a thin, that is narrow diameter, electrode which minimises the surface area contact with the vessel wall in circumstances where the distal end of the electrode is not deployed in the centre of the vessel.
It is to be appreciated that the level of power applied through the electrode and the time of application will be dependent upon factors including the size of the vessel, the amount and speed blood flow through the vessel, pulsation and turbulence of blood at the point of ablation, and so on.
Although the preferred embodiment is a monopolar system, it is to be understood that the teachings herein can apply also to a bipolar system.
Referring first to
The electrode element 12 includes a distal end 20 which in this embodiment has an exposed electrode terminal 22 acting as the anode of the circuit. The electrode element 12 in some embodiments also includes a temperature sensor 24 for measuring temperature at the anode terminal 22, useful in determining the progress of ablation of the vessel.
The electrode element 12 also includes a sheath 26 of electrically insulating material which in practice covers the remainder of the electrode 22, such that a current path in use exists solely from the exposed terminal 22 at the distal end 20 of the electrode element 12.
The electrode element 12 is coupled electrically to a control unit 40, as is the cathode pad 14. As explained below, the control unit 40 is operable to provide energy to the electrode element 12, specifically current at RF frequencies. The anode terminal 22 and cathode pad 14 form a circuit for the RF energy, which will conduct through a patient's body between the anode terminal 22 and the cathode pad 14. It will be appreciated that the cathode pad 14 will be applied against the patient's skin, preferably at a position which is practicably as close as possible to the anode terminal 22, in order to provide this conduction path. There will be localised heating around the anode terminal 22, as a result of its significantly smaller surface area and as a result consequential heating of blood in the vicinity of the anode terminal 22, as explained in further detail below.
The control unit 40 typically includes a processing unit 42, a power delivery circuit 44 coupled to the anode and cathode elements of the system 10, typically one or more sensors including a temperature sensor unit 40 coupled to the temperature probe 24 and/or an impedance sensor unit 48 for measuring impedance between the anode 22 and cathode 14 of the system 10. In some embodiments both of types of sensor units 46 and 48 may be provided.
The control unit 40 may also include an electrode drive unit 50 for moving the electrode 12 within the patient's vessel 18. In some embodiments, the control unit 40 may be provided with a position sensor for measuring the position of the electrode 12 within a patient and in particular for measuring the retraction of the electrode 12 from within the vessel 18. Some embodiments may include both a drive unit 59 and a position sensor.
The processing unit 40 also includes a user interface 60 coupled to the control unit 40 and operable to provide data to a user and for input of user commands to the control unit 40. The user interface 60 may, in its simplest embodiment, include an on/off switch for operating the control unit 40 and therefore the RF ablation, with the control unit 40 then effecting the desired ablation process under the command of the unit 40 solely. In other embodiments, the user interface 60 may be more sophisticated and enable, for example, a user to select different modes of ablation and also to produce, for instance, occluding barriers of different lengths, as described in further detail below.
The user interface 60 preferably also includes an output for providing ablation feedback and/or warning signals to a user. It may, for example, provide an indication of measured temperature and/or impedance, an indication of progress of ablation of the vessel and so on. For such purposes, the user interface 60 may include a visual unit, for example a display to display quantitative data such as graphs, measures of temperature and impedance, determined length of occlusion and so on. In other embodiments the display may be simpler, having for instance simple visual indicators such as one or more illuminated lamps. The output could also be an acoustic output and/or, as appropriate, a tactile output such as a vibration generator and so on. Any combination of user feedback devices may be provided.
The apparatus 10 of
Referring first to
The progress of ablation in this phase is preferably controlled by one or more sensors, for instance by means of a temperature probe 24 and temperature sensor unit 46 in the control unit 50 and/or by measuring the impedance of the circuit formed by the apparatus 10 when in operation. In practice, sensing temperature will aim to detect an increase in temperature indicative of passing a threshold at which blood will coagulate to form a clot 70, whereas measurement of impedance will determine when a sufficient amount of blood has clotted around the anode tip 22 to cause a drop in measured current and consequential increase in impedance.
It is not to be excluded that the control unit 50 could be operated without sensors, for example for a predetermined period of time at a predetermined energy which is considered sufficient to create a blood clot of the required dimensions. This is, though, not preferred as it is preferable to have as precise as possible an indication of the actual state of clotting of blood within the vessel 18 and therefore of the occlusion which is formed.
Referring now to
In this embodiment, during this second phase the control unit 50 commands the power unit 44 to apply energy at a second power level lower than the first power level applied during the phase of
It will be appreciated that the retraction of the anode tip 22, by means of retraction of the electrode element 12, may be effected manually by the medical practioner or automatically by means of a drive unit 50 provided in or coupled to the control unit 40. A suitable drive unit will be apparent to someone of average skill in the art.
Referring now to
The degree of clotting during the second phase of the ablation process of
The process of partial retraction and RF ablation at a lower power level depicted in
At the end of the second RF ablation phase, the electrode and consequently the anode tip 22 are completely retracted from the treatment site and the vessel 18, thereby to leave a blood clot formed of a first blood clot 70 and secondary blood clots 80, 82. At this stage the control unit 50 will have commanded the power unit 44 to cut all power to the electrodes 22, 14. As can be seen, there is produced a blood clot formation 70-82 which is completely sealed and which, moreover, is not unduly long.
Referring first to
In the embodiment of
The processing unit 42 continues to monitor the position of the anode tip 22 and when it is determined that it has been retracted by a predetermined distance deemed sufficient to close the thrombus formation 70, the processing unit 42 moves to step 210, at which it commands the power unit 44 to switch off power to the terminals 22. Then, at step 212, the electrode element 12 and therefore the anode tip 22 are removed from the vessel.
In its simplest form, the embodiment of
Another embodiment of mode of operation of the apparatus 10 of
At step 302 the control unit 42 commands the power unit 44 to apply RF energy to the anode tip 22, whilst at the same time measuring temperature and/or impedance at the anode tip 22. At step 304, the processing unit 42 determines whether the temperature and/or impedance has reached the first threshold and if it has not, step 302 continues to operate. On the other hand, when it is determined at step 304 that the first threshold has been reached, operation passes to step 306, at which the control unit commands retraction of the anode tip 22 by a given distance. This may be by operating the drive unit 50 shown in
It is to be understood that between steps 308 to 310, the control unit 40 and in particular the processing unit 42 may command a process equivalent to steps 108 and 110 in the embodiment of
Thus, the embodiment of
All optional and preferred features and modifications of the described embodiments and dependent claims are usable in all aspects of the invention taught herein. Furthermore, the individual features of the dependent claims, as well as all optional and preferred features and modifications of the described embodiments are combinable and interchangeable with one another.
| Number | Date | Country | Kind |
|---|---|---|---|
| 1406496.8 | Apr 2014 | GB | national |
