ELECTROSURGICAL SYSTEM
20220202490 · 2022-06-30
Inventors
- Christopher HANCOCK (Chepstow, GB)
- Shaun Preston (Chepstow, GB)
- William TAPLIN (Chepstow, GB)
- Sandra SWAIN (Chepstow, GB)
- George ULLRICH (Bangor, GB)
- David WEBB (Bangor, GB)
Cpc classification
A61B8/12
HUMAN NECESSITIES
A61B2017/0019
HUMAN NECESSITIES
A61B2018/1892
HUMAN NECESSITIES
A61B2017/00194
HUMAN NECESSITIES
A61B2018/1869
HUMAN NECESSITIES
A61B2018/00982
HUMAN NECESSITIES
A61B2018/1861
HUMAN NECESSITIES
A61B2018/00994
HUMAN NECESSITIES
International classification
Abstract
An electrosurgical system for treating biological tissue that comprises: an electrosurgical generator to supply microwave energy; a surgical scoping device having a steerable insertion cord for insertion to a treatment site; and an electrosurgical instrument dimensioned to fit within an instrument channel that is located within the insertion cord. The electrosurgical instrument comprises: a flexible coaxial cable arranged to convey the microwave energy; and a radiating tip portion connected at an end of the coaxial cable and configured to receive microwave energy. The radiating tip portion comprises: a coaxial transmission line for conveying the microwave energy; and a needle tip mounted at an end of the proximal coaxial transmission line, wherein the electrosurgical instrument is slidable within the instrument channel to extend the needle tip beyond an end of the instrument channel to puncture biological tissue; the needle tip is arranged to deliver the microwave energy into biological tissue.
Claims
1. An electrosurgical system for treating biological tissue, the electrosurgical system comprising: an electrosurgical generator configured to supply microwave energy; a surgical scoping device having a steerable insertion cord for minimally invasive insertion to a treatment site within a body; and an electrosurgical instrument dimensioned to fit within an instrument channel that is located within the insertion cord, wherein the electrosurgical instrument comprises: a flexible coaxial cable arranged to convey the microwave energy; and a radiating tip portion connected at a distal end of the coaxial cable and configured to receive the microwave energy, wherein the radiating tip portion has a maximum outer diameter that is 1.0 mm or less, and wherein the maximum outer diameter of the radiating tip portion is smaller than an outer diameter of the coaxial cable, wherein the radiating tip portion comprising: a proximal coaxial transmission line for conveying the microwave energy; and a distal needle tip mounted at a distal end of the proximal coaxial transmission line, wherein the electrosurgical instrument is slidable within the instrument channel to extend the distal needle tip beyond a distal end of the instrument channel to puncture biological tissue, and wherein the distal needle tip is arranged to deliver the microwave energy into biological tissue.
2. An electrosurgical system according to claim 1, wherein the surgical scoping device is an ultrasound-enabled bronchoscope.
3. An electrosurgical system according to claim 1, wherein the electrosurgical instrument further comprises a protective catheter mounted around the radiating tip portion, wherein the catheter is movable within the instrument channel, and wherein the radiating tip portion is movable relative to the catheter.
4. An electrosurgical system according to claim 1, wherein the electrosurgical generator is configured to supply pulsed microwave energy having a pulse duration that is shorter than a thermal response time of the radiating tip portion.
5. An electrosurgical system according to claim 4, wherein the electrosurgical generator is configured to supply the pulsed microwave energy with a duty cycle of 25% or less.
6. An electrosurgical system according to claim 4, wherein a pulse duration of the pulsed microwave energy is between 10 ms and 200 ms.
7. An electrosurgical system according to claim 1, wherein a length of the radiating tip portion is equal to or greater than 140 mm.
8. An electrosurgical system according to claim 1, wherein the proximal coaxial transmission line comprises: an inner conductor that extends from a distal end of the flexible coaxial cable, the inner conductor being electrically connected to a centre conductor of the flexible coaxial cable; a proximal dielectric sleeve mounted around the inner conductor; and an outer conductor mounted around the proximal dielectric, wherein the distal needle tip comprises a distal dielectric sleeve mounted around the inner conductor, and wherein a distal portion of the outer conductor overlays a proximal portion of the distal dielectric sleeve.
9. An electrosurgical system according to claim 8, wherein distal dielectric sleeve is made from a different material compared to the proximal dielectric sleeve.
10. An electrosurgical system according to claim 9, wherein a proximal end of the distal dielectric sleeve includes a protrusion disposed around the inner conductor, and wherein the protrusion is received in a complementarily shaped cavity at a distal end of the proximal dielectric sleeve.
11. An electrosurgical system according to claim 1, wherein the distal needle tip is configured to operate as a half wavelength transformer to deliver the microwave energy from the distal needle tip.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0048] Embodiments of the invention are discussed below with reference to the accompanying drawings, in which:
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DETAILED DESCRIPTION; FURTHER OPTIONS AND PREFERENCES
[0063]
[0064] The electrosurgical system 100 further includes an interface joint 106 that is connected to the electrosurgical generator 102 via 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 system may be arranged, additionally or alternatively, to aspirate fluid from a 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.
[0065] The interface joint 106 may house an instrument control mechanism for controlling a position of the electrosurgical instrument. The control mechanism may be used to control a longitudinal position of the electrosurgical instrument, and/or bending of a distal end of the electrosurgical instrument. The Control mechanism is operable by sliding a trigger, to control a 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. A 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 (or electrosurgical instrument) 112, which extends from the distal end of the interface joint 106.
[0066] The electrosurgical system further includes a surgical scoping device 114, which in embodiment of the present invention may comprise an endoscopic ultrasound device. The flexible shaft 112 is insertable through an entire length of an instrument (working) channel of the surgical scoping device 114.
[0067] The surgical scoping device 114 comprises a body 116 having a number of input ports and an output port from which an insertion cord 120 extends. The insertion cord 120, which is illustrated in more detail in
[0068] An endoscopic ultrasound device typically provides an ultrasound transducer on a distal tip of the insertion cord, beyond an exit aperture of the instrument channel. Signals from the ultrasound transducer may be conveyed by a suitable cable 126 back along the insertion cord to a processor 124, which can generate images in a known manner. The instrument channel may be shaped within the insertion cord to direct an instrument exiting the instrument channel through the field of view of the ultrasound system, to provide information about the location of the instrument at the target site.
[0069] The flexible shaft 112 has a distal assembly 118 (not drawn to scale in
[0070] The structure of the distal assembly 118 discussed below may be particularly designed for use with an endoscopic ultrasound (EUS) device. The maximum outer diameter of the distal assembly 118 is equal to or less than 1.0 mm, e.g. less than 0.95 mm or 0.90 mm. The length of the flexible shaft can be equal to or greater than 1.2 m.
[0071] The body 116 includes an 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 pulsed microwave energy from the electrosurgical generator 102 to the distal assembly 118. Example coaxial cables that are physically capable of fitting down the instrument channel of an EUS device 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 (i.e. made to order) may also be used.
[0072] In order to control a position of a distal end of the insertion cord 120, the body 116 may further include a control actuator that is mechanically coupled to the distal end of the insertion cord 120 by one or more control wires (not shown), which extend through the insertion 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 insertion cord 120 may be software-assisted, e.g. using a virtual three-dimensional map assembled from computer tomography (CT) images.
[0073] The invention may be particularly suited for treatment of the pancreas. In order to reach a target site in the pancreas, the insertion cord 120 may need to be guided through the mouth, stomach and duodenum. The electrosurgical instrument is arranged to access the pancreas by passing through the wall of the duodenum. The invention may also be particularly suited to treatment of tissue in the liver.
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[0075] We will now describe an electrosurgical instrument 300 that may be part of an electrosurgical system of the invention, with reference to
[0076] The radiating tip portion 304 includes a proximal coaxial transmission line 306 and a distal needle tip 308 formed at a distal end of the proximal coaxial transmission line 306. The proximal coaxial transmission line 306 is electrically connected to the distal end of the coaxial cable 302 to receive the electromagnetic energy from the coaxial cable 302 and convey it to the distal needle tip 308. The distal needle tip 308 is configured to deliver the received electromagnetic energy into target biological tissue. In the present example, the distal needle tip 308 is configured as a half wavelength transformer to deliver microwave energy into target biological tissue, to ablate the target tissue. In other words, an electrical length of the distal needle tip 308 corresponds to a half wavelength of the microwave energy (e.g. at 5.8 GHz). When microwave energy is delivered to the distal needle tip 308 it may radiate the microwave energy along its length into surrounding biological tissue.
[0077] An inner conductor 310 of the proximal coaxial transmission line 306 is electrically connected to the centre conductor of the coaxial cable 302. The radiating tip portion 304 is secured to the coaxial cable 302 via a collar 312 mounted over a junction between the coaxial cable 302 and the radiating tip portion 304. The collar 312 is made of a conductive material (e.g. brass), and electrically connects the outer conductor of the coaxial cable 302 to an outer conductor 314 of the proximal coaxial transmission line 306. The outer conductor 314 is formed of a tube of nitinol, which is flexible and provides a sufficient longitudinal rigidity to pierce tissue (e.g. the duodenum wall). For illustration purposes, the outer conductor 314 is omitted from
[0078] The proximal coaxial transmission line 306 includes a proximal dielectric sleeve 320 which is disposed around the inner conductor 310 and which spaces the inner conductor 310 from the outer conductor 314. The outer conductor 314 is formed on an outer surface of the proximal dielectric sleeve 320. A distal dielectric sleeve 322 is disposed around a distal portion of the inner conductor 310 to form the distal needle tip 308. The distal needle tip 308 further includes a pointed tip 324 at its distal end, to facilitate insertion of the radiating tip portion into target tissue. The distal dielectric sleeve 322 may be made of a different dielectric material compared to the proximal dielectric sleeve 504. In one example, the proximal dielectric sleeve 504 may be made of PTFE (e.g. it may be a PTFE tube) and the distal dielectric sleeve may be made of PEEK. Specific examples of materials that may be used in the radiating tip portion 304 are discussed below in relation to
[0079] A distal portion of the outer conductor 314 overlays a proximal portion of the distal dielectric sleeve 322. In this manner, a distal portion of the proximal coaxial transmission line 306 includes the proximal portion of the distal dielectric sleeve 322. The materials of the proximal and distal dielectric sleeves and the length of the overlap between the outer conductor 314 and the distal dielectric sleeve 322 may be selected in order to adjust an electrical length of the radiating tip portion 308 and impedance matching with target tissue.
[0080] The collar 312 includes a substantially cylindrical body 316 which is mounted on the distal end of the coaxial cable 302 and which is electrically connected to the outer conductor of the coaxial cable 302. The collar 312 further includes a distal portion 318 which extends from the body 316 of the collar 312 to a proximal end of the outer conductor 314 of the proximal coaxial transmission line 306. The distal portion 318 of the collar 312 includes a distal surface which is rounded. This may reduce friction between the electrosurgical instrument 300 and an instrument channel of a surgical scoping device when the electrosurgical instrument 300 is moved along the channel, by avoiding sharp edges at the interface between the coaxial cable 302 and the radiating tip portion 304. This may also facilitate moving the electrosurgical instrument along the channel when the channel is in retroflex.
[0081] A maximum outer diameter of the radiating tip portion 304 is indicated in
[0082] An outer diameter of the coaxial cable 302 is indicated by arrows 328 in
[0083] In some embodiments, the electrosurgical instrument 300 may be housed in a catheter (not shown). The electrosurgical instrument 300 may be movable relative to the catheter, so that the radiating tip portion 304 can be retracted inside the catheter when not in use. This may serve to protect the radiating tip portion, and prevent it from catching on the insertion cord when it is inserted into the insertion cord of a surgical scoping device.
[0084] The radiating tip portion 304 may have a length equal to or greater than 30 mm, e.g. 40 mm. In this manner, the radiating tip portion 304 may be long enough for the distal needle tip 308 to reach a treatment site, without having to insert a portion of the coaxial cable 302 into tissue. In some cases the radiating tip portion 304 may have a length of 140 mm or greater. The inventors have found that this may facilitate inserting the electrosurgical instrument 300 into an insertion cord where a distal portion of the insertion cord is in retroflex, as it may avoid having to push the more rigid coaxial cable 302 through the distal portion of the insertion cord.
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[0086] As the radiating tip portion 304 of electrosurgical instrument has a small diameter (i.e. 1.0 mm or less), it may heat up rapidly when microwave energy is delivered to it. This may result in inefficient delivery of microwave energy to the distal needle tip. Heating of the radiating tip portion 304 may also cause damage to healthy surrounding tissue. The inventors have overcome this drawback by configuring the electrosurgical generator (e.g. electrosurgical generator 102) of the electrosurgical system of the invention to deliver the microwave energy in pulses. The inventors have found that pulsed delivery of microwave energy may avoid or reduce heating effects in the radiating tip portion, so that the radiating tip portion may be maintained at an acceptable temperature during a surgical procedure.
[0087] In order to avoid heating of the radiating tip portion during application of microwave energy, a pulse duration of the microwave pulses may be set to be greater than a thermal response time of the radiating tip portion. In this manner, the radiating tip portion may not have time to react thermally to the pulsed microwave energy on the timescale of the microwave pulses. The thermal response time of the radiating tip portion may be measured experimentally, by determining an amount of time taken for a temperature of the radiating tip portion to increase by a given amount (e.g. 5° C.) when microwave energy at a given power level (e.g. a power level to be used during an electrosurgical procedure) is delivered to the radiating tip portion. The pulse duration may then be set accordingly, to ensure that the temperature of the radiating tip portion remains at an acceptable temperature over the course of an electrosurgical procedure.
[0088] The inventors have found that configuring the electrosurgical generator to deliver pulsed microwave energy with a duty cycle of 25% or less may avoid or reduce heating effects in the radiating tip portion so that it may be maintained at an acceptable temperature during use. The electrosurgical generator may be configured to deliver microwave energy according to one of the following example cycles:
[0089] a) 10 ms pulse duration, with 90 ms between pulses;
[0090] b) 10 ms pulse duration, with 50 ms between pulses;
[0091] c) 10 ms pulse duration, with 30 ms between pulses;
[0092] d) 100 ms pulse duration, with 900 ms between pulses;
[0093] e) 100 ms pulse duration, with 500 ms between pulses;
[0094] f) 100 ms pulse duration, with 300 ms between pulses; and
[0095] g) 200 ms pulse duration, with 800 ms between pulses.
[0096] Cycles a) and d) correspond to a duty cycle of 10%; cycles b) and e) correspond to a duty cycle of 16.67%; cycles c) and f) correspond to a duty cycle of 25%; and cycle g) corresponds to a duty cycle of 20%.
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[0098] We will now describe specific examples of radiating tip portions of electrosurgical instruments that may be used in an electrosurgical system of the invention, with reference to
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[0100] Example dimensions of the radiating tip portion 700 are shown in
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[0102] Example dimensions of the radiating tip portion 800 are shown in
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[0105] Example dimensions of the radiating tip portion 900 are shown in
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[0107] Example dimensions of the radiating tip portion 1000 are shown in
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[0109] Example dimensions of the radiating tip portion 1100 are shown in
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[0111] In use, the instrument 700 may be extendable (e.g. slidable) beyond the protective catheter 1202 to protrude from the distal end of the insertion cord 120, where it is able to penetrate tissue to recite the treatment site. The radiating tip may be observed using the ultrasound imaging capability of the bronchoscope to assist in accurate location at the treatment site.