Patent Application
20230000552
The invention relates to an electrosurgical instrument for delivering radiofrequency and microwave energy to biological tissue in order to cut and coagulate the tissue. The electrosurgical instrument may be particularly suited for use in flexible endoscopy, e.g. sized to pass through an instrument channel of an endoscope. However, the invention may find applicability in other types of procedure, e.g. rigid laparoscopy or open surgery.
Surgical resection is a means of removing sections of unwanted tissue associated with organs within the human or animal body, such as the liver or the spleen or the bowel. When tissue is cut (divided or transected) small blood vessels called arterioles are damaged or ruptured. Initial bleeding is followed by a coagulation cascade where the blood is turned into a clot in an attempt to plug the bleeding point. During an operation, it is desirable for a patient to lose as little blood as possible, so various devices have been developed in an attempt to provide blood free cutting.
For example, the Hemostatix® Thermal Scalpel System combines a sharp blade with a haemostatic system. The blade is coated with a plastic material and connected to a heating unit which accurately controls the temperature of the blade. The intention is for the heated blade to cauterise the tissue as it is cut.
Other known devices that cut and stop bleeding at the same time do not use a blade. Some devices use radiofrequency (RF) energy to cut and/or coagulate tissue. Other devices (known as harmonic scalpels) use a rapidly vibrating tip to cut tissue.
The method of cutting using RF energy operates using the principle that as an electric current passes through a tissue matrix (aided by the ionic contents of the cells), the impedance to the flow of electrons across the tissue generates heat. When a pure sine wave is applied to the tissue matrix, enough heat is generated within the cells to vaporise the water content of the tissue. There is thus a huge rise in the internal pressure of the cell that cannot be controlled by the cell membrane, resulting in the cell rupturing. When this occurs over a wide area it can be seen that tissue has been transected.
RF coagulation operates by applying a less efficient waveform to the tissue, whereby instead of being vaporised, the cell contents are heated to around 65° C. This dries out the tissue by desiccation and also denatures the proteins in the walls of vessels and the collagen that makes up the cell wall. Denaturing the proteins acts as a stimulus to the coagulation cascade, so clotting is enhanced. At the same time the collagen in the wall is denatured from a rod like molecule to a coil, which causes the vessel to contract and reduce in size, giving the clot an anchor point, and a smaller area to plug.
The application of heat energy to biological tissue is also an effective method of killing cells. For example, the application of microwaves can heat and thus ablate (destroy) biological tissue. This method may in particular be used for the treatment of cancer as the cancerous tissue can be ablated in this way.
At its most general, the present invention provides an electrosurgical instrument which is capable of simultaneously ablating an area of tissue with microwave energy and performing resection with RF energy. The instrument has a distal bipolar energy delivery tip that has pen-like profile to emit a focussed RF field to facilitate accurate cutting of biological tissue.
According to the invention, there may be provided an electrosurgical instrument comprising: a coaxial transmission line for conveying radiofrequency (RF) energy and microwave energy; an energy delivery tip coupled to a distal end of the coaxial transmission line, wherein the energy delivery tip comprises: a first electrode electrically coupled to an inner conductor of the coaxial transmission line and protruding beyond a distal end of an outer conductor of the coaxial transmission line; a second electrode electrically coupled to the outer conductor of the coaxial transmission line and extending coaxially along a portion of the first electrode; and a dielectric body disposed between the first electrode and second electrode, wherein: the first electrode comprises a projecting nib that protrudes beyond a distal end of the dielectric body; the second electrode and the dielectric body comprise portions that are exposed at the distal end of the energy delivery tip; and the first electrode and second electrode are configured as (i) a bipolar structure for delivering the RF energy conveyed by the coaxial transmission line, and (ii) an antenna for radiating the microwave energy conveyed by the coaxial transmission line.
With the structure above, the instrument of the invention provides focussed delivery of RF energy at the protruding nib. which facilitates accurate cutting by operating the device as a pen to “draw” the cut line. Advantageously, the energy delivery unit is also configured to delivery microwave energy to all rapid coagulation in the event of a bleed. The RF and microwave energy may be applied separately or simultaneously.
In order to achieve an optimal focus of the RF energy, the energy delivery tip may have a distally facing end surface that comprises an exposed portion of the dielectric body and an exposed portion of the second electrode arranged concentrically around the projecting nib. Viewed from the front, the instrument may thus resemble a bullseye, with the protruding nib at its centre. The instrument may thus have rotational symmetry around a central longitudinal axis (e.g. the axis of the coaxial transmission line) so that the current effect is uniform regardless of the orientation of the instrument.
The distally facing end surface may be profiled to focus the delivered RF energy at the projecting nib. Profiling the distal end face may also assist in visibility, i.e. by ensuring that the protruding nib can be seen by the operator.
In one example, the distally facing end surface may be conical, i.e. tapered in a linear manner towards the protruding nib. The angle of the conical surface may be selected to assist with visibility and field focussing. In one example, the distally facing end surface may subtend an angle of 45° to a longitudinal axis of the projecting nib.
In another example, the distally facing end surface may be rounded, e.g. dome-like or hemispherical. With the protruding nib, this structure may give the energy delivery tip a bottlenose appearance. The exposed portion of the dielectric body preferably project distally further than the distal end of the exposed portion of the second electrode.
The first electrode may be formed by a distally extending portion of the inner conductor. In other words, the inner conductor may extend unbroken from the coaxial transmission line through the energy delivery tip to form the protruding nib.
However, in other examples, the first electrode may be a separate component from the inner conductor. It may be coupled to the inner conductor via a connector rod. The connector rod may be a further component, or may be formed integrally with the first electrode. An advantage of this configuration is that the dimensions of the connector rod and/or first electrode can be selected independently. This can assist with tuning the impedance of the energy delivery tip for the microwave energy, as discussed below.
The connector rod may comprise a proximal sheath that is secured to an outer surface of a distal end of the inner conductor. The first electrode may thus be connected as an extension of the inner conductor. The connector rod may be connected to the inner conductor by any suitable technique, although a mechanical connection such as crimping may be preferred.
The second electrode may comprise a conductive sleeve having a proximal portion that overlies a distal portion of the outer conductor. The conductive sleeve may be electrically connected and physically secured to the outer conductor in the proximal portion. For example, the conductive sleeve may be secured to the outer conductor by crimping.
The instrument may further comprise an outer insulating jacket, arranged to cover a distal portion of the coaxial transmission line and a proximal portion of the energy delivery tip. The jacket may protect the coaxial transmission line and energy delivery tip and prevent energy from leaking from the structure except at the distal tip.
The antenna may be configured as an impedance transformer to couple the microwave energy into biological tissue. In other words, the energy delivery tip may be configured to transform the impedance of the coaxial transmission line to a typical tissue impedance for the microwave energy. For example, the first electrode, dielectric body and second electrode may have lengths selected to cause the energy delivery tip to operate as a quarter wavelength transformer for the microwave energy.
The instrument may be dimensioned to fit through the instrument channel of a surgical scoping device. For example, the instrument may have a maximum outer diameter equal to or less than 2.0 mm. In some examples, the instrument can be further miniaturised to have a maximum outer diameter equal to or less than 1.0 mm. The protruding nib may have a diameter equal to or less than 0.2 mm. The protruding nib may have a length equal to or less than 1.0 mm.
The term “surgical scoping device” may be used herein to mean any surgical device provided with an insertion tube that is a rigid or flexible (e.g. steerable) conduit that is introduced into a patient's body during an invasive procedure. The insertion tube may include the instrument channel and an optical channel (e.g. for transmitting light to illuminate and/or capture images of a treatment site at the distal end of the insertion tube. The instrument channel may have a diameter suitable for receiving invasive surgical tools. The diameter of the instrument channel may be 5 mm or less. In embodiments of the invention, the surgical scoping device may be an ultrasound-enabled endoscope.
Herein, the term “inner” means radially closer to the centre (e.g. axis) of the instrument channel and/or coaxial cable. The term “outer” means radially further from the centre (axis) of the instrument channel and/or coaxial cable.
The term “conductive” is used herein to mean electrically conductive, unless the context dictates otherwise.
Herein, the terms “proximal” and “distal” refer to the ends of the elongate probe. In use, the proximal end is closer to a generator for providing the RF and/or microwave energy, whereas the distal end is further from the generator.
In this specification “microwave” may be used broadly to indicate a frequency range of 400 MHz to 100 GHz, but preferably the range 1 GHz to 60 GHz. Preferred spot frequencies for microwave EM energy include: 915 MHz, 2.45 GHz, 3.3 GHz, 5.8 GHz, 10 GHz, 14.5 GHz and 24 GHz. 5.8 GHz may be preferred. The device may deliver energy at more than one of these microwave frequencies.
The term “radiofrequency” or “RF” may be used to indicate a frequency between 300 kHz and 400 MHz.
Embodiments of the invention are discussed below with reference to the accompanying drawings, in which:
The generator 102 is connected to an interface joint 106 by an interface cable 104. The interface joint 106 is also connected via a fluid flow line 107 to a fluid delivery device 108, such as a syringe. In some examples, the apparatus may be arranged, additionally or alternatively, to aspirate fluid from the treatment site. In this scenario, the fluid flow line 107 may convey fluid away from the interface joint 106 to a suitable collector (not shown). The aspiration mechanism may be connected at a proximal end of the fluid flow line 107.
If needed, the interface joint 106 can house an instrument control mechanism that is operable by sliding a trigger, e.g. to control longitudinal (back and forth) movement of one or more control wires or push rods (not shown). If there is a plurality of control wires, there may be multiple sliding triggers on the interface joint to provide full control. The function of the interface joint 106 is to combine the inputs from the generator 102, fluid delivery device 108 and instrument control mechanism into a single flexible shaft 112, which extends from the distal end of the interface joint 106.
The flexible shaft 112 is insertable through the entire length of an instrument channel (also known as a working channel) of a surgical scoping device 114, which in embodiment of the present invention may comprise an endoscope.
The surgical scoping device 114 comprises a body 116 having a number of input ports and an output port from which an instrument cord 120 extends. The instrument cord 120 comprises an outer jacket which surrounds a plurality of lumens. The plurality of lumens convey various things from the body 116 to a distal end of the instrument cord 120. One of the plurality of lumens is the instrument channel discussed above. Other lumens may include a channel for conveying optical radiation, e.g. to provide illumination at the distal end or to gather images from the distal end. The body 116 may include a eye piece 122 for viewing the distal end.
The flexible shaft 112 has a distal assembly 118 (not drawn to scale in
The distal end assembly 118 may be any of the electrosurgical instruments discussed below. The distal end assembly 118 may be particularly designed for use with conventional endoscopes. For example, a maximum outer diameter of the distal end assembly 118 may be equal to or less than 2.0 mm, e.g. less than 1.9 mm (and more preferably less than 1.5 mm) and the length of the flexible shaft can be equal to or greater than 1.2 m. In other example, the structure may be configured for use in even smaller spaces. For example, the maximum outer diameter of the distal end assembly 118 may be equal to or less than 1.0 mm.
The body 116 includes a power input port 128 for connecting to the flexible shaft 112. As explained below, a proximal portion of the flexible shaft may comprise a conventional coaxial cable capable of conveying the radiofrequency and microwave energy from the generator 102 to the distal assembly 118. Coaxial cables that are physically capable of fitting down the instrument channel of an endoscope are available with the following outer diameters: 1.19 mm (0.047″), 1.35 mm (0.053″), 1.40 mm (0.055″), 1.60 mm (0.063″), 1.78 mm (0.070″). Custom-sized coaxial cables having even smaller diameters, e.g. 0.8 mm or less, may also be used.
As discussed above, it is desirable to be able to control the position of at least the distal end of the instrument cord 120. The body 116 may include a control actuator that is mechanically coupled to the distal end of the instrument cord 120 by one or more control wires (not shown), which extend through the instrument cord 120. The control wires may travel within the instrument channel or within their own dedicated channels. The control actuator may be a lever or rotatable knob, or any other known catheter manipulation device. The manipulation of the instrument cord 120 may be software-assisted, e.g. using a virtual three-dimensional map assembled from computer tomography (CT) images.
The coaxial transmission line 202 comprises an inner (centre) conductor 204 that is separated from a concentrically arranged outer conductor 208 by a dielectric (electrically insulating) layer 206. An outer surface of the outer conductor 208 is covered by a jacket 210, which providing protection and electrically insulates the outer conductor 208.
A distal end of the coaxial transmission line 202 is connected to the distal energy delivery tip 212. The distal energy delivery tip 212 comprises a dielectric body 216 that extends in a longitudinal direction towards a distal end of the instrument. The longitudinal direction is aligned with the axis of the coaxial cable at the distal end thereof. The dielectric body 216 may be generally cylindrical, and may have an outer diameter that is less than the outer diameter of the coaxial transmission line 202. The dielectric body 216 may be made of the same or a different material to the dielectric layer 206 in the coaxial transmission line 202.
The dielectric body 216 has a hollow longitudinally extending passage running therethrough. The passage may be machined to have appropriate dimensions. At a proximal end, the passage in the dielectric body 216 receives a portion of the inner conductor 204 that extends beyond a distal end of the dielectric layer 206. The inner conductor 204 is electrically coupled to a first electrode 220. The first electrode 220 comprises a rod element that includes a distal portion disposed in the passage of the dielectric body 216 and a proximal portion that protrudes (is exposed at) the distalmost end of the energy delivery tip 212. In this example, the first electrode 220 is electrically (and physically) coupled to the inner conductor 204 by a connector rod 218. The connector rod 218 may be made from an electrically conductive material, e.g. the same material as the inner conductor 204 and/or first electrode 220. The connector rod 218 may have a proximal sleeve part that is secured (e.g. via crimping 224) to a distal part of the inner conductor 204. The first electrode 220 may be integrally formed with the connector rod 218, or may be a separate component that is secured to it.
In practice, the distal energy delivery tip 212 may be manufactured by the following steps:
stripping the dielectric layer 206 and outer conductor 208 from a distal length of the inner conductor 204;
securing the connector rod 218 to the exposed inner conductor 204;
forming, e.g. by wrapping, moulding or the like, the dielectric body 216 around the connector rod.
The energy delivery tip 212 further comprises a second electrode 214, which comprises a conductive sleeve mounted around the dielectric body 216. The conductive sleeve is electrically coupled to the outer conductor 208 of the coaxial transmission line. In this example, a proximal portion of the conductive sleeve is both electrically and physically coupled to a distal portion of the outer conductor 208 via crimping 222.
The jacket 210, which is made from an insulating material extends beyond the coaxial transmission line 202 to cover a portion of the conductive sleeve. However, the jacket 210 stops short of the distal end of the energy delivery tip 212, whereby a distal end portion 230 of the second electrode 214 is exposed.
The distal end of the energy delivery tip 212 therefore resembles a bullseye, comprising: a central projecting nib that is part of the first electrode 220, an exposed portion 232 of the dielectric body 216, and an exposed portion 230 of the second electrode 214 that is separated from the first electrode by the dielectric body 216. The distalmost end of the projecting nib 220 may be rounded, e.g. to prevent snagging on biological tissue in used.
This structure provides a bipolar structure for delivering RF energy. The first electrode 220 and second electrode 214 form active and return poles for the bipolar structure. The bullseye configuration acts to generate a preferential energy flow along the distalmost surface, with an increased energy density at and around the central nib. Such an energy distribution is advantageous for cutting. The instrument may be operated like a pen, because the cutting effect occurs preferentially at the projecting nib. The focussing of the RF energy may occur because the conductive surface area of the projecting nib 220 is less than the surface area of the exposed portion 230. The focussed energy distribution may mean that cutting starts from the projecting nib. The device is therefore intuitive to use.
The distal end of the energy delivery tip 212 may be profiled in a manner that facilitates energy delivery or operation. For example, in
In addition to delivery RF energy to cut biological tissue, the distal energy delivery tip 212 can be configured as a microwave antenna to deliver microwave energy for coagulation. The relative dimensions of the connector rod 218 and first electrode 220, the dielectric body 216 and second electrode 214 can be selected to ensure that the energy delivery tip 212 has an impedance suitable for coupling microwave energy into biological tissue. In one example, the energy delivery tip 212 may be configured as a quarter wave transformer at the frequency of microwave energy conveying by the coaxial transmission line 202. This configuration operates to facilitate coupling of microwave energy into tissue.
The structure may have a size that is suitable for insertion through the instrument channel of a surgical scoping device, e.g. an endoscope or the like. For example, the coaxial transmission line 202 may be a coaxial cable having an outer diameter of 1.6 mm. The second electrode 214 may have a maximum outer diameter of 2.0 mm. The radial gap between an inner surface of the second electrode 214 and the first electrode 220 (or connector rod 218), i.e. the minimum radial thickness of the dielectric body 216 between the first and second electrodes, may be 0.4 mm. The projecting nib 220 may have a maximum diameter of 0.2 mm.
The instrument may be capable of further miniaturisation. For example, the coaxial cable may have an outer diameter of 0.8 mm, such that the whole device can fit through a passage having a diameter of 1.0 mm.
The electrosurgical instrument 240 of
The electrosurgical instrument 240 of
| Number | Date | Country | Kind |
|---|---|---|---|
| 1917619.7 | Dec 2019 | GB | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2020/084128 | 12/1/2020 | WO |
