US 20070167943 A1
A method of managing a system of minimally invasive surgery. The management method includes providing a practitioner with a minimally invasive surgery system including a controller. One or more use parameters is stored to memory associated with the controller. In addition, an electrosurgical probe having its own memory is provided to mate with the remaining elements of the system. Complementary use parameters are stored in the memory of the probe. The management method also includes communicating and comparing the use parameters of the controller with the complementary use parameters of the probe and managing the use of the electrosurgical probe according to the use parameters.
1. A method of managing a system for minimally invasive surgery comprising:
providing a controller with memory to a practitioner;
writing one or more use parameters to the memory of the controller;
providing an electrosurgical probe with memory;
writing one or more complementary use parameters to the memory of the probe;
comparing the use parameters of the controller with the complementary use parameters of the electrosurgical probe; and
managing use of the electrosurgical probe according to the use parameters.
2. The method of managing a system for minimally invasive surgery of
3. The method of managing a system for minimally invasive surgery of
4. The method of managing a system for minimally invasive surgery of
5. The method of managing a system for minimally invasive surgery of
6. The method of managing a system for minimally invasive surgery of
7. The method of managing a system for minimally invasive surgery of
8. The method of managing a system for minimally invasive surgery of
9. The method of managing a system for minimally invasive surgery of
10. The method of managing a system for minimally invasive surgery of
11. The method of managing a system for minimally invasive surgery of
12. A system for minimally invasive surgery comprising:
a controller associated with memory;
an electrosurgical probe associated with memory;
a communication link between the controller and the electrosurgical probe;
means for comparing a use parameter stored in the memory of the controller with a complementary use parameter stored in the electrosurgical probe; and
managing use of the electrosurgical probe according to the use parameters.
13. The system for minimally invasive surgery of
14. The system for minimally invasive surgery of
15. The system for minimally invasive surgery of
16. The system for minimally invasive surgery of
17. An electrosurgical probe comprising:
a probe body defining a longitudinal probe axis;
multiple conductive electrodes operatively disposed along the probe axis;
a stimulation current source in electrical communication with at least one of the conductive electrodes; and
a blunt tip operatively disposed at a first end of the probe.
18. The electrosurgical probe of
19. The electrosurgical probe of
20. The electrosurgical probe of
21. An electrosurgical probe comprising:
a probe body defining a longitudinal probe axis;
multiple conductive electrodes operatively disposed along the probe axis;
a stimulation current source in electrical communication with at least one of the conductive electrodes;
a handle operatively associated with the probe body; and
a switch operatively associated with the handle wherein selective actuation of the switch may increase or decrease the application of stimulation current to at least one conductive electrode.
22. The electrosurgical probe of
23. The electrosurgical probe of
24. The electrosurgical probe of
25. The electrosurgical probe of
26. The electrosurgical probe of
27. A system for minimally invasive surgery comprising:
an electrosurgical probe;
a source of ablation current in electrical communication with the electrosurgical probe;
means for automatically delivering a therapeutic quantity of energy from the source of ablation current to the electrosurgical probe.
28. The system for minimally invasive surgery of
29. The system for minimally invasive surgery of
30. The system for minimally invasive surgery of
31. A method of minimally invasive surgery comprising:
providing a controller in communication with a source of ablation current;
providing an electrosurgical probe in electrical communication with the source of ablation current; and
automatically supplying a therapeutic quantity of energy from the source of ablation current to the electrosurgical probe according to a select therapeutic energy protocol stored in memory associated with the controller.
32. The method of minimally invasive surgery of
33. The method of minimally invasive surgery of
34. The method of minimally invasive surgery of
This application is a continuation-in-part of U.S. application Ser. No. 10/870,202, filed Jun. 17, 2004, entitled “Ablation apparatus and system to limit nerve conduction,” now published, which is hereby incorporated by reference.
The present invention relates to a method and device used in the field of Minimally Invasive Surgery (or MIS) for interrupting the flow of signals through nerves. These nerves may be rendered incapable of transmitting signals either on a temporarily (hours, days or weeks) or a permanent (months or years) basis. One embodiment of the apparatus includes a single puncture system which features electrodes capable of creating areas of nerve destruction, inhibition and ablation.
The human nervous system is used to send and receive signals. The pathway taken by the nerve signals conveys sensory information such as pain, heat, cold and touch and command signals which cause movement (e.g. muscle contractions).
Often extraneous, undesired, or abnormal signals are generated (or are transmitted) along nervous system pathways. Examples include, but are not limited to, the pinching of a minor nerve in the back, which causes extreme back pain. Similarly, the compression or other activation of certain nerves may cause referred pain. Certain diseases also may compromise the lining of nerves such that signals are spontaneously generated, which can cause a variety of maladies, from seizures to pain or (in extreme conditions) even death. Abnormal signal activations can cause many other problems including (but not limited to) twitching, tics, seizures, distortions, cramps, disabilities (in addition to pain), other undesirable conditions, or other painful, abnormal, undesirable, socially or physically detrimental afflictions.
In other situations, the normal conduction of nerve signals can cause undesirable effects. For example in cosmetic applications the activation of the corrugator supercilli muscle causes frown lines which may result in permanent distortion of the brow (or forehead); giving the appearance of premature aging. By interruption of the corrugator supercilli activation nerves, this phenomenon may be terminated. Direct surgical interruption of nerves is however a difficult procedure.
Traditional electrosurgical procedures use either a unipolar or bipolar device connected to that energy source. A unipolar electrode system includes a small surface area electrode, and a return electrode. The return electrode is generally larger in size, and is either resistively or capacitively coupled to the body. Since the same amount of current must flow through each electrode to complete the circuit; the heat generated in the return electrode is dissipated over a larger surface area, and whenever possible, the return electrode is located in areas of high blood flow (such as the biceps, buttocks or other muscular or highly vascularized area) so that heat generated is rapidly carried away, thus preventing a heat rise and consequent burns of the tissue. One advantage of a unipolar system is the ability to place the unipolar probe exactly where it is needed and optimally focus electrosurgical energy where desired. One disadvantage of a unipolar system is that the return electrode must be properly placed and in contact throughout the procedure. A resistive return electrode would typically be coated with a conductive paste or jelly. If the contact with the patient is reduced or if the jelly dries out, a high-current density area may result, increasing the probability for burns at the contact point.
Typical bipolar electrode systems are generally based upon a dual surface device (such as forceps, tweezers, pliers and other grasping type instruments) where the two separate surfaces can be brought together mechanically under force. Each opposing surface is connected to one of the two source connections of the electrosurgical generator. Subsequently, the desired object is held and compressed between the two surfaces. When the electrosurgical energy is applied, it is concentrated (and focused) so that tissue can be cut, desiccated, burned, killed, stunned, closed, destroyed or sealed between the grasping surfaces. Assuming the instrument has been designed and used properly, the resulting current flow will be constrained within the target tissue between the two surfaces. One disadvantage of a conventional bipolar system is that the target tissue must be properly located and isolated between these surfaces. Also, to reduce extraneous current flow the electrodes can not make contact with other tissue, which often requires visual guidance (such as direct visualization, use of a scope, ultrasound or other direct visualization methods) so that the target tissue is properly contained within the bipolar electrodes themselves, prior to application of electrical energy.
In recent years, considerable efforts have been made to refine sources of RF or electrical energy, as well as devices for applying electrical energy to specific targeted tissue. Various applications such as tachyarrhythmia ablation have been developed, whereby accessory pathways within the heart conduct electrical energy in an abnormal pattern. This abnormal signal flow results in excessive and potentially lethal cardiac arrhythmias. RF ablation delivers electrical energy in either a bipolar or unipolar configuration utilizing a long catheter, similar to an electrophysiology (EP) catheter. An EP catheter consisting of a long system of wires and supporting structures normally introduced via an artery or vein which leads into the heart is manipulated using various guidance techniques, such as measurement of electrical activity, ultrasonic guidance, and/or X-ray visualization, into the target area. Electrical energy is then applied and the target tissue is destroyed.
A wide variety of technology in the development of related systems, devices and EP products has already been disclosed. For example, U.S. Pat. No. 5,397,339, issued Mar. 14, 1995, describes a multipolar electrode catheter, which can be used to stimulate, ablate, obtain intercardiac signals, and can expand and enlarge itself inside the heart. Other applications include the ability to destroy plaque formations in the interior of lumens within the body; using RF energy applied near, or at the tip of, catheters such as described in U.S. Pat. No. 5,454,809 and U.S. Pat. No. 5,749,914. In these applications a more advanced catheter which is similar to the EP catheters described above contains an array of electrodes that are able to selectively apply energy in a specific direction. Such devices allow ablation and removal of asymmetric deposits or obstructions within lumens in the body. U.S. Pat. No. 5,098,431 discloses another catheter based system for removing obstructions from within blood vessels. Parins, in U.S. Pat. No. 5,078,717 discloses yet another catheter to selectively remove stenotic lesions from the interior walls of blood vessels. Auth in U.S. Pat. No. 5,364,393 describes a modification of the above technologies whereby a small guide wire which goes through an angioplasty device and is typically 110 cm or longer has an electrically energized tip, which creates a path to follow and thus guides itself through the obstructions.
In applications of a similar nature, catheters which carry larger energy bursts, for example from a defibrillator into chambers of the heart have been disclosed. These catheters are used to destroy both tissues and structures as described in Cunningham (U.S. Pat. No. 4,896,671).
Traditional treatments for the elimination of glabellar furrowing have included surgical forehead lifts, resection of corrugator supercilli muscle, as described by Guyuron, Michelow and Thomas in pi Corrugator Supercilli Muscle Resection Through Blepharoplastylncision., Plastic Reconstructive Surgery 95 691-696 (1995). Also, surgical division of the corrugator supercilli motor nerves is used and was described by Ellis and Bakala in Anatomy of the Motor Innervation of the Corrugator Supercilli Muscle: Clinical Significance and Development of a New Surgical Technique for Frowning., J Otolaryngology 27; 222-227 (1998). These techniques described are highly invasive and sometimes temporary as nerves regenerate over time and repeat or alternative procedures are required.
More recently, a less invasive procedure to treat glabellar furrowing involves injection of botulinum toxin (Botox) directly into the muscle. This produces a flaccid paralysis and is best described in The New England Journal of Medicine, 324:1186-1194 (1991). While minimally invasive, this technique is predictably transient; so, it must be re-done every few months.
Specific efforts to use RF energy via a two needle bipolar system has been described by Hernandez-Zendejas and Guerrero-Santos in: Percutaneous Selective Radio-Frequency Neuroablation in Plastic Surgery, Aesthetic Plastic Surgery, 18:41 pp 41-48 (1994) The authors described a bipolar system using two parallel needle type electrodes. Utley and Goode described a similar system in Radio-frequency Ablation of the Nerve to the Corrugator Muscle for Elimination of Glabellar Furrowing, Archives of Facial Plastic Surgery, January-March, 99, VI P 46-48, and U.S. Pat. No. 6,139,545. These systems were apparently unable to produce permanent results possibly because of limitations inherent in a two needle bipolar configuration. Thus, as is the case with Botox, the parallel needle electrode systems would typically require periodic repeat procedures.
There are many ways of properly locating an active electrode near the target tissue and determining if it is in close proximity to the nerve. Traditional methods in the cardiac ablation field have included stimulation by using either unipolar and bipolar energy by means of a test pacemaker pulse prior to the implantation of a pacemaker or other stimulation device. A method of threshold analysis called the ‘strength duration curve has been used for many years. This curve consists of a vertical axis (or Y-axis) typically voltage, current, charge or other measure of amplitude, and has a horizontal axis (or X-axis) of pulse duration (typically in milliseconds). Such a curve is a rapidly declining line, which decreases exponentially as the pulse width is increased.
Various stimulation devices have been made and patented. One process of stimulation and ablation using a two-needle system is disclosed in U.S. Pat. No. 6,139,545. The stimulation may also be implemented negatively, where tissue not responsive to stimulation is ablated as is described in U.S. Pat. No. 5,782,826 (issued Jul. 21, 1998).
One aspect of the present invention is an electrosurgical probe including a probe body which defines a longitudinal probe axis. Thus the probe resembles a single needle and can be placed into tissue through a single opening. The electrosurgical probe also includes a first and second conductive electrode, each disposed along the probe axis. The surface area of the first conductive electrode is, in this aspect of the invention, greater than the surface area of the second conductive electrode. The ratio of the surface area of the first conductive electrode to the surface area of the second conductive electrode may be equal to or greater than 3:1 or equal to or greater than 8:1. The ratio of the surface area of the first conductive electrode to the surface area of the second conductive electrode may be adjustable.
The electrosurgical probe of the subject invention may further include a stimulation energy source in electrical communication with either the first or the second conductive electrode. Similarly, the electrosurgical probe may also include an ablation energy source communicating with either the first or second conductive electrode. A switch may be provided for the selective connection of the stimulation energy source or the ablation energy source to at least one of the conductive electrodes. Either the first or the second conductive electrode may be nearer the point of the electrosurgical probe at one end of the probe axis.
Another aspect of the present invention is an electrosurgical probe including a probe body defining a longitudinal probe axis, an active electrode operatively associated with the probe body at a first location along the probe axis, a stimulation electrode associated with the probe body at a second location along the probe axis and a return electrode operatively associated with the probe body at a third location along the probe axis. The stimulation electrode may be positioned between the active and return electrodes. The electrosurgical probe of this embodiment may further include a stimulation energy source in electrical communication with the stimulation electrode. The stimulation energy source may provide variable stimulation current. Either the active electrode, the return electrode or both may be connected to a ground for the stimulation energy source. Alternatively, a separate ground may be employed. This aspect of the present invention may also include an ablation energy source connected to the active electrode. The ablation energy source may be configured to provide variable ablation energy.
Another aspect of the present invention is an electrosurgical probe also having a probe body defining a longitudinal probe axis. At least three electrodes will be associated with the probe body at distinct and separate locations along the probe axis. A stimulation energy source connected to at least one of the electrodes is also included.
The stimulation energy source of this embodiment of the present invention may be configured to provide variable stimulation energy. In addition, the stimulation energy source may be selectively connected by means of a switch to at least one or more of the various electrodes. Similarly, a ground for the stimulation energy source may be selectively connected to one or more of the electrodes.
Another aspect of the present invention is a method for positioning an electrosurgical probe. The method includes providing an electrosurgical probe such as those described immediately above, inserting the electrical surgical probe to a first position within tissue containing a target nerve and applying stimulation energy to an electrode. Upon the application of stimulation energy, a first response of a muscle associated with the target nerve may be observed. Thereupon, the electrosurgical probe may be moved to a second position and a second application of stimulation energy may be undertaken. The method further includes observing a second response of a muscle associated with the target nerve and comparing the second response with the first response. The method may also include varying the level of stimulation energy between the first and second applications of stimulation current. If the electrosurgical probe provided to implement the method has a third electrode, stimulation energy may be applied to a select third electrode as well. Certain advantages will be observed with respect to positioning the electrosurgical probe if stimulation energy is sequentially applied to first, second, third and subsequent electrodes.
Another aspect of the present invention is a method of managing a system of minimally invasive surgery. The management method includes providing a practitioner with a minimally invasive surgery system including a controller. One or more use parameters is stored to memory associated with the controller. In addition, an electrosurgical probe having its own memory is provided to mate with the remaining elements of the system. Complementary use parameters are stored in the memory of the probe. The management method also includes communicating and comparing the use parameters of the controller with the complementary use parameters of the probe and managing the use of the electrosurgical probe according to the use parameters. The use parameters may include items such as a practitioner identification designation, a controller identification designation and a permitted therapeutic protocol. Other use parameters may be devised. This aspect of the present invention may also include maintaining a probe use flag in the electrosurgical probe memory.
Another aspect of the present invention is a system for minimally invasive surgery including a controller associated with memory, an electrosurgical probe associated with memory, a communication link between the controller and the probe and means for comparing use parameters stored in the memory of the controller with complementary use parameters stored in the electrosurgical probe. In addition, the system includes means for managing use of the electrosurgical probe according to the use parameters.
Another aspect of the present invention is an electrosurgical probe having a probe body defining a longitudinal probe axis with multiple conductive electrodes operatively disposed along the probe axis. The probe also includes a stimulation current source in electrical communication with at least one conductive electrode and a blunt tip operatively disposed at a first end of the probe.
Another aspect of the present invention is an electrosurgical probe including a probe body defining a longitudinal probe axis, multiple conductive electrodes operatively disposed along the probe axis, and a stimulation current source in electrical communication with at least one of the conductive electrodes. This aspect of the present invention further includes a handle operatively associated with the probe body and a switch operatively associated with the handle. The switch is selected so that selective actuation of the switch may increase or decrease the application of stimulation current to at least one conductive electrode. The switch may also be configured such that an alternative actuation of the switch allows the application of ablation current to at least one conductive electrode.
Another aspect of the present invention is a system for minimally invasive surgery including an electrosurgical probe, a source of ablation current in electrical communication with the electrosurgical probe and apparatus for automatically delivering a therapeutic quantity of energy from the source of ablation current to the electrosurgical probe. The therapeutic quantity of energy may include a select waveform, a select energy application duration, or a predetermined power profile that varies over time. Other attributes of the therapeutic quantity of energy are possible.
Another aspect of the present invention is a method of minimally invasive surgery which includes automatically supplying a therapeutic quantity of energy from a source of ablation current such as is described above.
FIG. 3D Magnified side view of split conical bi-polar probe.
Certain terms used herein are defined as follows:
Corrugator supercili muscles—skeletal muscles of the forehead that produce brow depression and frowning.
Cepressor anguli oris—skeletal muscle of the corner of the mouth that produces depression of the corner of the mouth.
Depressor labii inferioris—skeletal muscle of the lower lip that causes the lip to evert and depress downward.
Dystonias—medical condition describing an aberrant contraction of a skeletal muscle which is involuntary.
Frontalis—skeletal muscle of the forehead that produces brow elevation or raising of the eyebrows.
Hyperhidrosis—condition of excessive sweat production.
Masseter—skeletal muscle of the jaw that produces jaw closure and clenching.
Mentalis—skeletal muscle of the lower lip and chin which stabilizes lower lip position.
Orbicularis oculio—skeletal muscle of the eyelid area responsible for eyelid closure.
Orbicularis ori—skeletal muscle of the mouth area responsible for closure and competency of the lips and mouth.
Parasymapathetic—refers to one division of the autonomic nervous system.
Platysma myoides—skeletal muscle of the neck that protects deeper structures of the neck.
Platysma—same as above.
Procerus muscles—skeletal muscle of the central forehead responsible for frowning and producing horizontal creasing along the nasofrontal area.
Procerus—same as above.
Rhinorrhea—excessive nasal mucous secretions.
Supercilli—a portion of the corrugator muscle that sits above the eyelids.
Temporalis—skeletal muscle of the jaw that stabilized the temporamandibular joint.
Zygomaticus major—skeletal muscle of the face that produces smiling or creasing of the midface.
ADC: Analog to digital converter.
ASCII: American standard of computer information interchange.
BAUD: Serial communication data rate in bits per second.
BYTE: Digital data 8-bits in length.
CHARACTER: Symbol from the ASCII set.
CHECKSUM: Numerical sum of the data in a list.
CPU: Central processing unit.
EEPROM: Electronically erasable programmable read only memory.
FLASH MEMORY: Electrically alterable read only memory. (See EEPROM)
UI: Graphical user interface.
HEXADECIMAL: Base 16 representation of integer numbers.
12C BUS: Inter Integrated Circuit bus. Simple two-wire bidirectional serial bus developed by Philips for an independent communications path between embedded ICs on printed circuit boards and subsystems.
The I2C bus is used on and between system boards for internal system management and diagnostic functions.
INTERRUPT: Signal the computer to perform another task.
PC: Personal computer.
PWM: Pulse-width modulation.
ROM: Read only memory.
WORD: Digital data 16-bits in length
In normal operation, the novel probe 371 would combine a unique bipolar configuration in a single MIS needle, is inserted into the patient using MIS techniques. The probe, which may contain and/or convey various functions described later, is initially guided anatomically to the region of the anticipated or desired location. Various means of locating the tip 301 are utilized of placing the zone of ablation in the proper area to interrupt signal flows through the nerve 101.
Many combinations of electrode diameters and tip shapes are possible. The ‘novel’ probe performs a variety of functions, such as stimulation, optical and electronic guidance, medication delivery, sample extraction, and controlled ablation. This bi-polar electrode is designed as a small diameter needle inserted from a single point of entry thus minimizing scaring and simplifying precise electrode placement. This low cost, compact design provides a new tool to the art.
Probes may emit fiber optic illumination for deep applications using electronic guidance as taught in
First the probe electrode 301 must be in the desired location relative to the target nerve 101 (
For example, both a high amplitude sine wave 910 (
The output of the modulator 415 is applied to the input of the power amplifier 416 section. The power amplifier's 416 outputs are then feed into the impedance matching network 418, which provides dynamic controlled output to the biologic loads that are highly variable and non-linear, and require dynamic control of both power levels and impedance matching. The tuning of the matching network 418 is performed for optimal power transfer for the probe, power level, and treatment frequencies settled. The system's peak power is 500 watts for this disclosed embodiment. Precise control is established by the proximity of the tip and the control loops included in the generator itself The final energy envelope 420 is delivered to probe tip 301 and return electrodes 302.
This precise control of energy permits extension of the ablation region(s), 140 and 1203 (
A low energy nerve stimulator 771 has been integrated into the system to assist in more precise identification of nearby structures and for highly accurate target location. Lastly, additional sensors, such as temperature 311, voltage, frequency, current and the like are read directly from the device and/or across the communications media 403 to the probe.
In addition to the substantial radially-symmetric ablation patterns with probes as taught in 371 (
The power amplifier output 430 and buffered the feedback signals 437 are connected to an Analog to Digital converter (or ADC) 431 for processor analysis and control. Said signals 437 control power modulation 420 settings and impact the impedance matching control signals 419. This integrated power signal 437 is recorded to the operating-condition database (
At power startup, the controller 401 (
The controller 401 also verifies selected procedure 1415 (
Nerve Target Location Tools
Prior to treatment, the practitioner may use auxiliary probe 771 (
Location Via Florescence Marker Dye.
In other procedures, whereby somewhat larger targets are sought, such as more diffuse nerve structures or small areas of abnormal growth (e.g. such as cancer) the injection of specially designed dyes that attach to target structures are used, as taught in
Electronic Probe Guidance
Low energy nerve stimulation current 810 (
Optical Probe Guidance
Disclosed invention provides optical sources 408 that aid in probe placement (
Data and Voice
Real-time engineering parameters are measured such as average power 437, luminous intensity 478, probe current 811, energy 438 and, temperature 330 to be recoded into USB memory 438. Simultaneously, the internal parameters disclosed such as frequency 423, modulation 420 and such are recoded into USB memory 438 as well. Additionally probe, patient, and procedure parameters (
At procedure conclusion, the system transfers the data 438 recorded to the USB removable memory 1338 and to a file server(s) 1309 and 1307. In the disclosed embodiment, data transfer is performed over Ethernet connection 480. Probe usage records 1460 (
Before further explaining the disclosed embodiment of the present invention in detail, it is to be understood that the invention is not limited in its application or to the details of the particular arrangement shown. The invention is capable of other embodiments. Further, the terminology used herein is for the purpose of describing the probe and its operation. Each apparatus embodiment described herein has numerous equivalents.
Bi-polar probe 310 represents probes 371, 372, 373 shown in FIGS. 3A-C with exception to type of needlepoint on the probe. FIG. 3D varies from the other because it has a split return probe. Bi-polar probe 310 (not drawn to scale) consists of insulating dielectric body 309 made from a suitable biology inert material, such as Teflon, PTFE or other insulative material, covering electrode 302 except for where 302 is exposed as a return electrode. Conductive return electrode 302 tube is fabricated from medical grade stainless steel, titanium or other conductive material. Hollow or solid conductive tip electrode 301 protrudes from surrounding dielectric insulator 305. Sizes of 309, 302, 305, and 301 and its inner lumen (diameter, length, thickness, etc.) may be adjusted so as to allow for different surface areas resulting in specific current densities as required for specific therapeutic applications.
Hollow Electrode 301 often used as a syringe to deliver medication such as local anesthetic. Tip electrode 301 is connected to power amplifier 416 via impedance matching network 418 (
Ablation regions 306 and 140 extend radially about electrode 301 generally following electric field lines. For procedures very close to skin 330 a chance of burning exists in region 306. To minimize the chance of burning, a split return electrode probe 374 in FIG. 3D is offered. Thereby concentrating the current away from region 306 to 140 or vice versa. In
The bi-polar probe 380 (not drawn to scale) consists of an insulating dielectric body 309 made from a suitable biologically inert material, such as Teflon PTFE or other electrical insulation, that covers split return electrodes 302 and 303. The disclosed conductive return electrodes 302 and 303 are fabricated from medical grade stainless steel, titanium or other electrically conductive material. Hollow or solid split conductive tip electrodes 301 and 311 protrude from the surrounding dielectric insulator 305. The operation of the hollow/split conductive tip is very similar to probe tip 310 as taught in FIG. 3D. Ablation regions 1203 (
Bi-polar probe 371 discloses conical shaped electrode 301 and tip 351 for minimally invasive single point entry. Probe diameter 358 is similar to a 20-gage or other small gauge syringe needle, but may be larger or smaller depending on the application, surface area required and depth of penetration necessary. In disclosed embodiment, electrode shaft 302 is 30 mm long with approximately 5 mm not insulated. Lengths and surface areas of both may be modified to meet various applications such as in cosmetic surgery or in elimination of back pain. The conductive return electrode 302 is fabricated from medical grade stainless steel, titanium or other conductive material. The dielectric insulator 305 in the disclosed embodiment is a transparent medical grade material such as polycarbonate, which may double as a light pipe or fiber optic cable. The high intensity light source 408 LED/laser (
The hollow chisel electrode 352 is often used as a syringe to deliver medication such as local anesthetic, medications,/tracer dye. The hollow electrode may also extract a sample. Dielectric insulator 305 in the disclosed embodiment is a transparent medical grade polycarbonate and performs as a light pipe or fiber optic cable. The novel dual-purpose dielectric reduces probe diameter and manufacturing costs. Light source 408, typically a LED or laser (
The bi-polar probe 373 discloses a tapered conical shaped probe for minimally invasive single point entry. It is constructed similarly to probe 371 as taught in
FIG. 3D Split Conical Bi-Polar Probe
Description of this probe is described in both drawings 2A and 3D. Bi-polar probe 374 (not drawn to scale) consists of insulating dielectric body 309 made from a suitable biologically inert material, such as Teflon, that covers split return electrodes 302 and 303. Conductive return electrodes 302 are fabricated from medical grade stainless steel, titanium or other suitable conductive material. Hollow or solid split conductive tip electrodes 301 and 311 protrude from surrounding dielectric insulator 305. Their operation is very similar to probe tip 380 as taught in
Probe handle (not drawn to scale) encloses memory module 331, on/off switch 310 and mode switch 367. Temperature sensor 330 (located close to tip) monitors tissue temperature. Split electrode 380 (
Connections consist of a tapered dielectric sleeve 309 covering the ridged stainless electrode tube 302. Insulating sleeve 309 is made from a suitable biologically inert material, which covers electrode 302. Dielectric 305 insulates conical tipped electrodes 351 and 301.
Ablation probe 371 is inserted and directed anatomically into the area where the target nerve to be ablated (Box 531) is located. Test current 811 is applied (Box 532). If probe is located in the immediate proximity of the target nerve a physiological reaction will be detected/observed (Example: During elimination of glabellar furrowing, muscle stimulation of the forehead will be observed). If reaction is observed, then a mark may optionally be applied on the surface of the skin to locate the area of the nerve. Power is applied (Box 535) in an attempt to ablate the nerve. If physiological reaction is not observed, (Box 534) the probe will be relocated closer to the target nerve and the stimulation test will be repeated (Box 536 & 537). If no physiological reaction is observed, the procedure may be terminated (Box 544). Also, the probe may be moved in any direction, up, down, near, far, circular, in a pattern, etc. to create a larger area of ablation for a more permanent result.
In Box 537, if stimulation is observed again, then the ablation power may be set higher (Box 538), alternatively, as mentioned, the needle may be moved in various directions, or a larger dosage of energy may be reapplied, to form a larger area of ablation for more effective or permanent termination of signal conduction through the nerve. After delivery of power (Box 540), stimulation energy may be applied again (Box 541). If there is no stimulation, the procedure is completed (Box 544). If there is still signal flow through the nerve (stimulation or physiological reaction) then the probe may be relocated (Box 542) and the procedure is started over again (Box 533).
Auxiliary probes 771 and 772 (
Operation 530 (
Between each ablation, procedure 540 (
As an example and not a limitation, five ablation regions (140, 141, 142, 143, and 144) are shown in
Probe insertion and placement is same as taught in
In special cases were target nerve 101 or ablation region 640 is in close proximity to second nerve 111 or skin 330 bi-polar probes 371 or 372 (
Probe construction is similar to
This probe may be used in conjunction with any of the therapeutic probes 371 and their derivatives. The needle itself will be very fine in nature, such as an acupuncture type needle. By its small size, numerous needle insertions may be accomplished with no scarring and minimal pain. The probe 771 will be inserted in the vicinity of the target tissue through skin 330. The exposed tip of 771, 702 will be exposed and electrically connected to generator 732 via wire 734. The surface of probe 771 is covered with dielectric 704 so the only exposed electrical contact is surface 702 and return electrode 736. Exposed tip 702 will be advanced to the vicinity of target 101 and test stimulation current will be applied. Appropriate physiological reaction will be observed and when the tip 702 is properly located, depth will be noted via observing marks 765. External mark 755 may be applied for reference. Ablation probe 371 may then be advanced to the proximity of the target tissue under the X mark 755 and ablation/nerve destruction as described elsewhere may be performed.
Dual tipped probe 772 offers an additional embodiment that eliminates return electrode pad 736. Probe frame/handle 739 holds two fine needles, 702 and 701, in the disclosed embodiment that are spaced a short distance (a few mm)-mm apart (730). The shaft of conductive needle 701 is covered with dielectric insulator 706, similar to the construction of probe 771 (
Probes 702 and 701 are very small gage needles similar in size to common acupuncture needles, thus permitting repeated probing with minimal discomfort, bleeding, and insertion force. Sharp probes are inserted thru skin 330 and muscle layer(s) 710 near nerve 101. The practitioner locates target nerve 101, then the skin surface may be marked 755 as location aide for ablation step as shown in flow chart (
Auxiliary probes 771 and 772 (
Auxiliary probe 771 and 772 provide a method to quickly locate shallow or deep target structures. Shallow structures are typically marked with ink pen allowing illuminated ablation probe 371 or its equivalents to be quickly guided to mark 755. Optionally, non-illuminated probes may be used by the practitioner who simply feels for the probe tip. For deep structures, probe 771 may also be employed as an electronic beacon; small current 811 (which will be lower intensity and different from the stimulating current) from probe tip 702 is used to guide ablation probe 372. Amplifier 430 (
Lower energy pulse width modulated (or PWM) sinusoid 920 for coagulation is also well known to electro-surgery art. Variations of cut followed by coagulation are also well known.
Auxiliary probes 771 and 772 (
Ablation probe 372 is inserted thru skin 330 and muscle layer(s) 710 near nerve 101. Illumination source 408 permits practitioner to quickly and accuracy guide illuminated 448 ablation probe 372 into position. Illumination 448 from ablation probe as seen by practitioner 775 is used as an additional aide in depth estimation. Selectable nerve simulation current 811 aids nerve 101 location within region 1204. This novel probe placement system gives practitioner confidence system is working correctly so s/he can concentrate on the delicate procedure. Accurate probe location permits use of minimal energy during ablation, minimizing damage to non-target structures and reducing healing time and patient discomfort.
Region 1203 shows the general shape of the ablation region for conical tip 301. Tip 301 is positioned in close proximity to target nerve 101. Ablation generally requires one or a series of localized ablations. Number and ablation intensity/energy are set by the particular procedure and the desired permanence.
Five ablation regions are illustrated 140, 141, 142, 143, and 144; however, there could be more or less regions. Ablation starts with area 144, then the probe is moved to 143 and so on to 140, conversely, ablations could start at 140 and progress to 144. Also, the practitioner could perform rotating motions, thus further increasing the areas of ablation and permanence of the procedure. Between each ablation procedure 540 (
Controller 101 maintains local probe 1460, patient 1430, and procedure 1410 databases. All work together to insure correct probes and settings are used for the desired procedure. Automatically verifying that the attached probe matches selected procedure and verifying probe authentication and usage to avoid patient cross contamination or use of unauthorized probes. Automatic probe inventory control quickly and accurately transfers procedure results to the billing system.
From a touch screen, the practitioner selects the desired procedure from list 1410. For example “TEMPORARY NERVE CONDUCTION” 1411, “SMALL TUMOR ICC” 1412, and “SMALL NERVE ABLATE” 1413 are a few of the choices. Each procedure has a unique procedure code 1416 to be used in the billing system. Power range parameter 1417 is a recommended power setting via power level control 404. The recommended probe(s) Associated with procedure 1415 and power range parameter 1417 are listed in parameters 1419. With the probe connected, the part number is read from memory 331 (
From touch screen 450 (
During the procedure (
Use of a USB memory stick permits continued operation in the event of a network 1326 failure Data is loaded to memory 1338 for simple transfer to office computer 1306 (
If computer network 1326 such as Ethernet 802.11 or wireless 802.11x is available, files are mirrored to local storage 1309, remote server 1307. The remote server (typically maintained by equipment manufacture) can be remotely update procedure(s). To insure data integrity and system reliability a high availability database engine made by Birdstep of Americas Birdstep technology, Inc 2101 Fourth Ave. Suite 2000, Seattle Wash. is offered as an example. The Birdstep database supports distributed backups, extensive fault and error recovery while requiring minimal system resources.
From a touch screen, the practitioner selects or enters patient name from previous procedure 1430 and creates a new record 1433. Similarly, a procedure is selected from 1410 (for example “TEMPORARY NERVE CONDUCTION” 1411, “SMALL TUMOR ICC” 1412, and “SMALL NERVE ABLATE” 1413). Each procedure has a unique procedure code 1416 that is used for the billing system. Other information such as practitioners name 1440, date 1435 is entered to record 1433. As taught above probe appropriate for the procedure is connected and verified, part 1470 and serial number 1469 recorded.
The practitioner enters additional text notes to file 1442 or records them with microphone 455 (
At the end of procedure, records are updated and stored to memory 438. Backup copies are written to USB 1320 memory stick 1338 (
Alternative Probe Configurations
In an equal electrode surface area implementation, one of the conductive electrodes 2002, 2004 may be selectively connected to a stimulation current source or an ablation current source as described above. The other electrode 2002, 2004 may be unconnected or connected as a ground or return path for the connected current source. In the embodiment shown in
Since electrodes 2002 and 2004 have substantially equal surface area, the local heating formed upon the application of RF ablation energy to the active electrode 2002 results in a heating zone having a substantially symmetrical ellipsoid form.
The single axis electrosurgical probe 2000 of
The probe 2000 of
The probe 2000 of
Several methods of properly positioning a probe adjacent to a selected nerve for ablation energy application are discussed above. For example, probe placement methods featuring florescence marker dyes, optical probe guidance and electronic probe guidance with the use of low energy nerve stimulation current are discussed in detail. Certain of the alternative probe configurations as illustrated in
The single axis electrosurgical probe 2000 of
For example, the
In probe embodiments where the stimulation electrode is positioned in between the ablation electrodes 2030, 2032, the above described iterative method guarantees that the target nerve is positioned within an elliptical ablation zone 2064 (see
The multiple electrodes of the
For example, with reference to
Sequentially, the stimulation current is then applied between electrodes 2050 and 2052 with similar strong muscle response observed. This sequential stimulation and response process is observed through the activation of electrodes 2056 and 2058 where the muscle response is substantially diminished or not observable. This is an indication that electrodes 2048 through 2056 are all in contact with the nerve 2042. The electrodes 2048 through 2056 may then be switched to the ablation current source activated and sequentially or simultaneously in bi-polar pairs or individually in bi-polar or mono-polar mode to ablate the nerve 2042. The nerve could be ablated along a select length defined by the number of electrodes activated by the practitioner. This method could also be implemented in mono-polar mode whereby stimulation or ablation energy is applied between one or more electrodes 2046 through 2062 and a separate return electrode applied externally on the body.
The above methods of angular probe positioning and sequential stimulation may be combined with the iterative techniques also described above. For example, the stimulation current generator may be set at a relatively high level initially and reduced when the general location of the nerve with respect to certain electrodes is determined.
For example, the stimulation current threshold (to elicit an observable response) between electrodes 2048 and 2050 of
The apparatus and methods described above may be implemented with various features which enhance the safety, ease of use and effectiveness of the system. For example, the probe may be implemented with an ergonomic and functional handle which enhances both operational effectiveness and provides for the implementation of safety features. Individual probes may be carefully managed, preferably with system software to assure that a selected probe functions properly, is sterile and not reused, and that the proper probe is used for each specific treatment procedure. Similarly, safeguards may be included with the system to assure that the operator is certified and trained for the specific treatment protocol selected. Various treatment management methods and specific treatment therapies may be selected for both the best results and for enhanced patient safety. In one embodiment, the treatment, therapeutic, and safety methods may be implemented with and rigorously controlled by software running on a processor associated with the ablation apparatus and system as is described in detail below.
System Management Method
The concurrent goals of patient safety, procedure efficiency and therapeutic success can be advanced through an effective system management method. A system management method such as is described herein may be implemented through computer software and hardware including computer processors and memory operating within or in association with the control console and the probe system described herein. Various interfaces between a practitioner, the control console, and the probe system may be present. In addition the hardware associated with an ablation system, including the probe stimulation current source, ablation current source, and the probe system may be in communication with and provide feedback to the system processor. Alternatively, the steps of the system management method could be implemented manually.
In a software and processor based system embodiment, the techniques described below for managing an electrosurgical probe and system may be implemented as a method, apparatus or article of manufacture using standard programming and/or engineering techniques to produce software, firmware, hardware, or any combination thereof. The term “article of manufacture” as used herein refers to code or logic implemented with or stored upon a medium or device (e.g., magnetic storage medium such as hard disk drives, floppy disks, tape), optical storage (e.g., CD-ROMs, optical disks, etc.), volatile and non-volatile memory devices (e.g., EEPROMs, ROMs, PROMs, RAMs, DRAMs, SRAMs, firmware, programmable logic, etc.). Code in the computer readable medium is accessed and executed by a processor. The code in which implementations are made may further be accessible through a transmission media or from a file server over a network. In such cases, the article of manufacture in which the code is implemented may comprise a transmission media such as network transmission line, wireless transmission media, signals propagating through space, radio waves, infrared, optical signals, etc. Of course, those skilled in the art will recognize that many modifications may be made to this configuration without departing from the scope of the implementations and that the article of manufacture may comprise any information bearing medium known in the art.
One aspect of a system management method consistent with the present invention is illustrated in
The probe ordering process begins with order information provided by the system or the practitioner. Selection of the customer/practitioner (step 3018) and retrieval of the practitioner's data (step 3020) from the encrypted customer database (step 3022) follows. Previously stored practitioner data may be retrieved and if necessary decrypted (step 3020, step 3022). Most importantly the prescribed probe protocols associated with the practitioner's system and certifications are determined (step 3024). At this point, the probe which is being ordered must be matched with the protocols of intended use and the practitioner's registered system, license and certification data. This match could be accomplished manually; however, manual probe ordering introduces the possibility of human error. Preferably, a sterile packaged probe is interrogated via RF, optical or wired link for approved treatment protocols. For example, the probe may be interrogated for approved protocols over a communications link (step 3026). This step may occur at the probe distribution location. In one embodiment the communications link is an RF link using ISO18000 part 3 protocol operating at 13.56 Mhz. Other suitable wired or wireless communication strategies could be used as well. A determination must be made whether the probe matches the allowed treatment protocols associated with the practitioner's system (step 3028). If no match occurs, an error message will be delivered in an automated implementation (step 3030 and step 3032). If a match is registered, session keys for use by hashing functions will be generated (step 3034). The session keys and other information are then written to memory associated with the selected sterile probe (step 3036). In step 3038 the probe serial number is returned to the system and a cyclic redundancy check (CRC) or other hash function is performed to verify both the correct serial number and proper information storage (step 3039). In a wireless implementation an incorrect CRC may result from communications failure. In this case, the probe may be reoriented for a better signal (step 3040). Upon the completion of probe ordering, a probe self test will typically be completed, before the probe is sent to a customer/practitioner.
In step 3041 the processor tests internal memory, the proper operation of the temperature sensor 311 and possibly other matters. A defective probe will generate an error message (step 3042 and step 3044). In such case the defective probe serial number will be written to local storage before the probe is sent for repair (step 3046 and step 3048). A probe passing self-test operation 3041 will be subject to a write clear of the used probe flag as discussed in more detail below (step 3050). Verification of the write clear of the used probe flag is performed (step 3052), with a failed verification resulting in the error notification and repair steps 3044-3048. If the write clear of the used probe flag is verified, the serial number of the probe is written to a record for inventory control (step 3054). This method permits the select probe to be tracked to a specific end user. The public key system detailed above keeps any given probe from accidentally or intentionally being used in non-certified equipment. Once the probe is self-tested it may be shipped to the practitioner (step 3056).
The methods detailed above and illustrated on
Assuming that the probe and control system or generator keys match, the system performs a pre-use probe self-test and calibration (step 3076). At this point in the process, the probe might be identified as defective, out of calibration or the prior use flag associated with the probe might be active, indicating a non-sterile probe which will result in an appropriate error message (step 3078 to step 3084). When a probe passes self-calibration, the serial number is read and the selected treatment protocol or selected energy bolus is matched with the authorized protocols for the probe (steps 3086 and 3088). In the event of a mismatch, an error message may be generated (step 3090). If a successful match is found the practitioner may insert the probe to perform a therapeutic protocol (step 3094). Representative therapeutic protocols are described above in Paragraphs 0163-0170 and illustrated in
As shown on
Real power is then measured (step 3112) as energy is delivered with power being integrated (step 3114) for total energy delivered. The optional probe temperature sensor is read and or a temperature profile is calculated (step 3116). For example, a 2D thermal model may be solved for real time temperature estimates assuming circular ablation lesion symmetry (step 3119). If the temperature is determined to be greater than desired as in step 3118, power is reduced (step 3120). If the temperature is less than desired, power is increased (step 3122). The watchdog timer is read at each step (step 3124). If the watchdog timer is timed out, there has possibly been a software or hardware failure and the RF amplifier is turned off (steps 3126, 3128). If the watchdog timer is not timed out the step timer is incremented (step 3130). If the currently selected protocol or energy bolus step timer has elapsed (step 3132) a step counter is incremented, the timer is reset (step 3134) and the next step (3136) is loaded for execution. If the last step associated with a select bolus is finished (step 3138), the energy delivery is terminated (step 3128). The foregoing steps assure that an integrated system as described herein will only deliver a prescribed therapeutic dosage, also known as an energy bolus. Thus over-treatment or burns may be avoided, enhancing patient safety.
As illustrated in
In summary, the steps illustrated on FIGS. 23A-C serve to verify that the probe is sterile (not used), properly calibrated and not defective. These steps also assure that the probe matches the current source or generator console, that the probe matches the certified treatment protocols for the practitioner and that the maximum treatment time dosage for a given treatment protocol is not exceeded. Thus the above steps assure that the probe and system are properly used to supply the selected treatment protocol, enhancing patient safety and treatment effectiveness.
The system of the present invention is preferably implemented with an integrated and attractively packaged control console which includes within one or related multiple housings a stimulation current source, an ablation energy source, and a practitioner interface unit. See
Therapeutic Treatment Protocols
As disclosed herein tissue ablation or a nerve block or other minimally invasive electrosurgical procedure may be performed with precisely applied RF energy. A fundamental requirement of the therapeutic RF waveform is to heat and denature human tissue in a small area over a selected time frame, for example, less than 25 seconds. Laboratory experiments indicate this to be a suitable time required to adequately ablate a small motor nerve. Longer or shorter treatment times may be required for other applications. The temperature required to denature the fine structure of the selected tissue, primarily proteins and lipids is approximately 65° C. and above.
To safely achieve appropriate ablation, nerve block or other treatment goals, the RF waveform may be generated and applied to meet the following criteria:
This range will prevent excessive tissue sticking as well as aid in the growth of an appropriate ablation lesion.
Initial RF power application should bring the temperature of the probe tip to a working therapeutic temperature in controlled manner, causing minimal overshoot. The time frame for the initial warming phase may be between 0.2 to 2.5 seconds.
To achieve the foregoing generalized goals, specific treatment protocols may be developed. In one embodiment of the present invention, the delivery of a specific therapeutic protocol (also described as an “energy bolus”) herein is automated. Automation can increase safety and treatment effectiveness since the practitioner may concentrate on probe placement while the system assures the delivery of the selected energy bolus. For example, the system controller 401 may be configured to control the waveform of energy supplied to an electrosurgical probe connected to the system. In particular, the wave shape, waveform modulation or pulse time may be controlled. Also, the total time during which power may be applied and maximum power or voltage limits may be set. In addition, a specific treatment protocol may be actively controlled according to feedback such as the probe temperature, adjacent tissue temperature, tissue impedance or other physical parameters which may be measured during the delivery of treatment energy. Specific energy delivery prescriptions or energy boluses may be developed for specific treatment goals. These energy prescriptions may be stored in memory associated with the controller as a permitted therapeutic protocol. A representative therapeutic energy protocol 3250 is shown in tabular form on
The therapeutic protocol 3250 of
The therapeutic treatment protocol 3250 illustrated on
As described above, the system may be configured to deliver a prescribed energy bolus automatically. Automated energy delivery can increase safety and treatment effectiveness, since the practitioner is free to concentrate on probe placement. The goals of enhanced patient safety and treatment effectiveness can be further advanced by providing an ergonomically appropriate probe with associated switches and control functions providing the practitioner with a tool that allows him to easily and safely initiate the automated delivery of an energy bolus while concentrating on probe placement. For example,
During the process of probe placement, the stimulation current level may be increased or decreased as described herein by sequentially depressing one of the forward or rearward sides of the rocker switch (see arrows 3276 and 3278) thus closing internal switches 314 and 315 respectively. A speaker associated with the system may emit a tone having a volume or frequency or other sound attribute substantially proportional to the amplitude setting of the stimulation current with each switch closure. This feature permits the practitioner to adjust the stimulation level without the necessity of adjusting any level dials or switches associated with the generator, allowing the practitioner to focus on critical probe placement.
When the stimulation process is complete, and the probe is positioned for treatment, the practitioner may depress switch 3264 at the center (see arrow 3280), thus closing both switches and commanding the generator to arm the ablation current source. It should be noted that the blunt tip embodiment permits iterative probe placement while minimizing the risk of cutting arteries or other structures as with a chisel or pointed tip. When the rocker switch is centrally depressed, the light 3266 may illuminate a select color, green for example, signaling to the practitioner that the system is ready to apply RF ablation energy. Without moving the probe, a pre-selected RF energy bolus may be delivered by closure of a foot switch (not shown). Light source 3266 may illuminate a different color, blue for example, during the application of RF ablation energy. In addition, the system generator may be configured to emit a tone signaling energy delivery. Thus, the disclosed probe and system may be used by a practitioner to skillfully implement one of the probe location and placement methods described herein, followed by the initiation of the automatic delivery of a selected energy bolus.
While the invention has been particularly shown and described with reference to a number of embodiments, it would be understood by those skilled in the art that changes in the form and details may be made to the various embodiments disclosed herein without departing from the spirit and scope of the invention and that the various embodiments disclosed herein are not intended to act as limitations on the scope of the claims.