Diffusive applicator for cold atmospheric plasma system

Abstract

An apparatus or device for performing cold atmospheric plasma procedures. The device or apparatus has a housing, a chamber within the housing, an entry port to the chamber, a plurality of exit ports from the chamber, and a plurality of electrodes mounted in the housing, each of the plurality of electrodes having a distal end adjacent one of the plurality of exit ports. The entry port, chamber, exit ports and plurality of electrodes are configured to provide for an inert gas flowing in the entry port and through the chamber to the exit port to become plasmatized by electrical energy applied to the plurality of electrodes to form a cold plasma flowing from the exit ports.

Claims

1. An apparatus for performing cold atmospheric plasma procedures, comprising: a housing; a chamber within said housing; an entry port to said chamber; a plurality of exit ports from said chamber, wherein each of said plurality of exit ports comprises an exit channel having a proximal end opening to said chamber and a distal end opening configured to allow gas flowing through said channel to exit the housing, wherein a distal end of one of said plurality of electrodes extends into each exit channel; a plurality of electrodes mounted in said housing, each of said plurality of electrodes having a distal end aligned with one of said plurality of exit ports; and a support member within each exit channel for supporting a portion of an electrode within the channel; wherein said entry port, said chamber, said exit ports and said plurality of electrodes are configured to provide for an inert gas flowing in said entry port and through said chamber to said exit ports to become plasmatized by electrical energy applied to said plurality of electrodes to form a cold plasma flowing from said exit ports.

2. The apparatus for performing cold atmospheric plasma procedures according to claim 1, further comprising: an electrical connector for connecting each of said plurality of electrodes to a source of electrosurgical energy; and a gas connector for connecting said entry port to said chamber to a source of inert gas.

3. The apparatus for performing cold atmospheric plasma procedures according to claim 2, further comprising a gas assisted electrosurgical generator, wherein said electrical connector and said gas connector are connected to said gas-assisted electrosurgical generator.

4. A cold atmospheric plasma apparatus comprising: a diffusive applicator assembly comprising: a bio-compatible plastic housing comprising: a distal end piece comprising: a side wall; a distal end face; a plurality of exit channels extending through said distal end face; and an electrode support member within each exit channel; and a proximal end piece connected to said distal end piece, said distal end piece comprising: an entry channel extending through said proximal end piece; a plurality of electrode channels extending through said proximal end piece; wherein said distal end piece and said proximal end piece form a chamber within said bio-compatible housing; and a plurality of electrodes, each electrode extending through one of said plurality of electrode channels into said chamber and each electrode further extending through said chamber into one of said plurality of exit channels, wherein each said electrode is supported by one of said electrode channels and an electrode support member in one of said exit channels.

5. The cold atmospheric plasma apparatus according to claim 4, further comprising: a connector for connecting said entry port to a source of inert gas and connecting said plurality of electrodes to a source of electrosurgical energy.

6. The cold atmospheric plasma apparatus according to claim 4, further comprising a handpiece connected to said bio-compatible housing.

7. The cold atmospheric plasma apparatus according to claim 4, further comprising an arm actuator connected to said bio-compatible housing.

8. The cold atmospheric plasma apparatus according to claim 4, further comprising a gas-assisted electrosurgical, wherein said plurality of electrodes and said entry channel are connected to said gas-assisted electrosurgical generator.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) For a more complete understanding of the present invention and the advantages thereof, reference is now made to the following description and the accompanying drawings, in which:

(2) FIG. 1 is a perspective view of a diffusive cold atmospheric plasma applicator in accordance with a preferred embodiment of the present invention.

(3) FIG. 2 is an assembly view of a diffusive cold atmospheric plasma applicator in accordance with a preferred embodiment of the present invention.

(4) FIG. 3 is a front view of a diffusive cold atmospheric plasma applicator in accordance with a preferred embodiment of the present invention.

(5) FIG. 4 is a side view of a diffusive cold atmospheric plasma applicator in accordance with a preferred embodiment of the present invention.

(6) FIG. 5 is a top view of a diffusive cold atmospheric plasma applicator in accordance with a preferred embodiment of the present invention.

(7) FIG. 6 is a bottom view of a diffusive cold atmospheric plasma applicator in accordance with a preferred embodiment of the present invention.

(8) FIG. 7 is a cross-sectional view of a diffusive cold atmospheric plasma applicator in accordance with a preferred embodiment of the present invention.

(9) FIG. 8 is a perspective cross-sectional view of a diffusive cold atmospheric plasma applicator in accordance with a preferred embodiment of the present invention.

(10) FIG. 9 is a diagram of a cold atmospheric plasma system incorporating a diffusive cold atmospheric plasma applicator in accordance with a preferred embodiment of the present invention.

(11) FIG. 10 is a diagram of an alternate embodiment of cold atmospheric plasma system incorporating a diffusive cold atmospheric plasma applicator in accordance with a preferred embodiment of the present invention.

(12) FIG. 11A is a diagram of a first embodiment of a system for producing cold plasmas for use with an applicator in accordance with the present invention.

(13) FIG. 11B is a diagram of a second embodiment of a system for producing cold plasmas for use with an applicator in accordance with the present invention.

(14) FIG. 11C is a diagram of a third embodiment of a system for producing cold plasmas for use with an applicator in accordance with the present invention.

(15) FIG. 11D is a diagram of a low frequency (LF) module and Cold Atmospheric Plasma (CAP) Probe for use with an applicator in accordance with a preferred embodiment of the present invention.

(16) FIG. 12 is a block diagram of a preferred embodiment of a gas-enhanced electrosurgical generator having a pressure control system in accordance with the present invention configured to perform a cold atmospheric plasma procedure.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

(17) A diffusive cold atmospheric plasma applicator in accordance with a preferred embodiment of the present invention is described with reference to FIGS. 1-8. As shown in FIG. 2, the applicator is an assembly of three different parts: a distal end piece 100, a proximal end piece 200 and a plurality of electrodes 300. The distal end piece and the proximal end piece may be a molded bio-compatible plastic such as acrylonitrile butadiene styrene (ABS), polytetrafluoroethylene (PFTE) or the like. The electrodes 300 are a conductive material such as Tungsten, stainless steel or copper, but other known conductive materials may be used. The invention is by no means limited to a housing that is an assembly proximal and distal end pieces, but rather, could be an assembly or more than two pieces or could have an integral housing incorporating the features of both the proximal and distal end pieces described herein.

(18) The distal end piece 100 has a contoured outer surface 102, 104, 106, a cylindrical inner face 109, an end face 110 and a ridge or lip 120. While the outer surface is contoured in the disclosed embodiment the invention is not limited to a particular design of the outer surface of the housing. The distal end piece further has a plurality of channels or exit ports 630 extending through the end face 110. Within each channel 630 there is an electrode support member 140 for supporting the distal end of an electrode 300. The support member 140 can take a variety of forms including but not limited to a plurality of ribs or flanges. On the interior of the distal end piece there is a shoulder 107.

(19) The proximal end piece 200 has a base portion 202 and a cylindrical portion 220 configured to insert into the distal end piece 100. The proximal end piece 200 has a central channel or entry port 610 that connects to a source of inert gas. The distal end piece further has a plurality of channels 201 for receiving and supporting electrodes. Each electrode channel 201 in the proximal end piece 200 corresponds to a channel 630 in the distal end piece. The distal end piece 100 and the proximal end piece 200 can be joined together by any means, such as welding, one or more locking mechanisms or thread.

(20) When the distal end piece and proximal end piece are assembled together they form a chamber within the applicator. In FIG. 7, the chamber could be considered all of areas 610, 620, 630 as a single chamber, as a plurality of chambers of differing sizes or as a chamber 620, an entry channel 610 and a plurality of exit channels 630. The nomenclature used, however, is insignificant. There must be an access port through which an inert gas can enter the chamber 620 and a plurality of exit ports through which cold atmospheric plasma can exit the chamber 620. In the embodiment shown in the figures, the entry channel or chamber 610 is smaller than the main chamber 620 and each exit channel or chamber 630 is smaller than the main chamber 620.

(21) The applicator, attachment or nozzle of the present invention further has a plurality of electrodes 300 whose proximal ends ultimately connect to a source of electrical energy. The plurality of electrodes can connect to each other and then have a single connecter to a generator or can have separate connectors. Each electrode 300 extends through an electrode support channel 201 in the proximal end piece 200 of the housing, through the main chamber 620 and into a channel or chamber 630 to position near the exit of the respective channel or chamber 630. The preferably the distal end of each electrode 300 is within about 1 mm of an exit of a channel or chamber 630. In an alternative embodiment, for example, a single electrode can extend through a single electrode support channel in the proximal end piece and then that electrode can split into a plurality of electrodes within the chamber 620 or be connected to a plurality of electrodes in chamber 620.

(22) The present invention is a system that integrates a large-scale diffusive cold plasma device with an electrosurgical system. The large-size diffusive cold plasma device or applicator allows treatment simultaneously large areas of the tissue (e.g. entire patient's organ) It is thermally harmless for the biological tissue and cannot cause burn. The cold plasma produces by the invented system is deadly for cancer cells while leaving normal cells unaffected.

(23) The attachment, applicator or nozzle of the present invention can be used in a variety of different arrangements. As shown in FIG. 9, the device 970 of the present invention can be used in a cold atmospheric plasma (CAP) system having a CAP generator 910 having an electrosurgical unit 912 and a cold plasma converter 914, and a gas source 920. The applicator is mounted at the end of an adjustable arm 930 that has an electrical line 940 that connects to electrodes 300 and a gas line 950 that connects to the entry port 910 within it. The electrical line connects to the electrosurgical generator on one end and to the electrodes 300 of the applicator at the other end. The gas line 950 connects to a gas source (through a gas controller). The arm 930 may have a handle or manipulator mechanism 960 near the applicator 970 for maneuvering the applicator to a desired position.

(24) In the embodiment of FIG. 9, the generator and cold plasma converter may be a system such as any of those disclose in U.S. patent application Ser. No. 15/991,609 or may be an integrated gas-assisted electrosurgical unit such as is disclosed in PCT/US2018/026894. Both of these prior applications are hereby incorporated by reference in their entirety.

(25) In other embodiments, the applicator can be arranged as shown in FIG. 10. Specifically, the applicant 1010 is connected to source of electrical energy and gas through a connector 1020 to electrical line 1030 and gas line 1040. The connector 1020 may be a simple connector, a handpiece or in a micro-invasive embodiment such as for use in a laparoscope or endoscope, a tube.

(26) The cold atmospheric plasma (CAP) system used with ah applicator of the present invention can be used with a variety of embodiments for generating cold atmospheric plasma. For example, the CAP system can take the form of any of the following.

(27) A first embodiment of a system for producing cold plasmas is shown in FIG. 11A. The system has a high frequency (HF) electrosurgical generator or ESU 1110a, a low frequency (LF) converter 1140a, a gas unit 1120, a gas supply 1130 and a cold atmospheric plasma (CAP) probe 1150. The CAP probe 1150 is connected to an output of the LF power converter 1140a and the gas unit 1120. The gas supply 1130 is a source of an inert gas such as helium. The gas unit 1120 controls the flow of the inert gas to the CAP probe 1150. The HF electrosurgical generator 1110a supplies high frequency (HF) energy for performing electrosurgical procedures such as electrocautery, argon plasma coagulation and others. The HF energy, for example, may have a frequency of 400 kHz, meaning that the generator outputs energy at a range of frequencies centered at 400 kHz. If the generator is set, for example, at a power of 100 W, the 100 W power at the center frequency of 400 kHz will dominate the signal. Power levels at frequencies surrounding that center frequency will be lower the further those surrounding frequencies are from the center frequency. Conventional electrosurgical generators operate in this manner and would be known to those of skill in the art. In conventional electrosurgical generators, the dominant central frequency typically is in the range of 300 kHz-600 kHz. This dominant central frequency sometimes may be referred to as the rated frequency.

(28) A variety of different configurations of the system are possible. In FIG. 11A the system is set up with the ESU 1110a, LF converter 1140a and gas unit 1120 as separate units. With such an arrangement, one could use a conventional electrosurgical generator and conventional gas unit in the system with a converter unit in accordance with the present invention to produce col atmospheric plasma. In FIG. 1A, the CAP probe has a gas connector to connect to the gas unit and an electrical connector to connect to the converter unit.

(29) Another embodiment of a system for performing CAP in accordance with the present invention is shown in FIG. 11B. In this embodiment, an electrosurgical generator 1100b has an HF module 1110b for producing high frequency energy and an LF power module 1140b connected to the HF module 1110b for converting HF power to LF power for use in CAP. In such an embodiment, the electrosurgical generator may have two electrical output ports, one for CAP and one for HF electrosurgery. The CAP probe would have an electrical connector for connecting to the LF port and the gas connector for connecting to the gas unit.

(30) In yet another embodiment shown in FIG. 11C, an integrated gas-enhanced electrosurgical unit 1100c has an HF power module 1110c, an LF power module 1140c, and a gas module 1220c. The integrated electrosurgical unit 1100c has a plurality of connector ports, for example a port 1102 for connecting an argon plasma probe to a gas supply from gas module 1120c and power from HF power module 1110c and a port 1104 for connecting a CAP probe to a gas supply from gas unit 1120c and an LF power supply from LF module 1140c.

(31) The LF converter 1140a, 1140b, 1140c utilizes a high voltage transformer 1142 connected to an output from ESU 1110a, 1110b, 1110c as shown in FIG. 11D. The transformer is a tuned transformer and is tuned to a lower frequency than the central frequency output from the ESU. In other words, the transformer operates as a resonant transformer with a resonant frequency lower than the output frequency of the ESU. For example, if the ESU outputs energy centered at 500 kHz, the transformer may have a resonant frequency of less than 300 kHz.

(32) In a preferred embodiment, the transformer utilizes a primary coil 1145 with N.sub.1=60-70 turns and secondary coil 1147 with about N.sub.2=300 turns. The coils are wound on a ferrite core. The specific number of turns utilized in the transformer is given for illustrative purpose only and can be varied in a very wide range. The number N.sub.2 should be larger than N.sub.1 in order to produce step-up conversion of the voltage.

(33) The LF converter up-converts voltage. In the preferred embodiment voltage of about 4 kV is produced. Other embodiments of the LF converter can be used to up-convert the voltage. The output voltage of the LF converter should be in a range 1.5-50 kV.

(34) The LF converter down-converts frequency because the resonant transformer amplifies primarily its own resonant frequency, and, therefore, that resonant frequency dominates the output. Outputted frequencies for CAP should be less than about 300 kHz and can be much less than 300 kHz, such as 30 kHz or lower.

(35) The LF converter additionally down-converts power due to the power being lower at the resonant frequency of the transformer and due to load mismatch. In the preferred embodiment, secondary coil can output power <10 Watt even when the ESU is set on a power of 120 W. The LF converter output power should not exceed 20-30 Watt. With a conversion unit of these types, a return electrode or patient plate is not needed due to the low power and low frequency.

(36) A gas pressure control system 1200 for controlling a plurality of gas control modules 1220, 1230, 1240 within a gas-enhanced electrosurgical generator is described with reference to FIG. 12. A plurality of gas supplies 1222, 1232, 1242 are connected to the gas pressure control system 1200, and more specifically, to the respective gas control modules 1220, 1230, 1240 within the gas pressure control system 1200. The gas pressure control system 1200 has a power supply 1202 for supplying power to the various components of the system. A CPU 1210 controls the gas pressure control modules 1220, 1230, 1240 in accordance with settings or instructions entered into the system through a graphical user interface on the display. The system is shown with gas control modules for CO.sub.2, argon and helium, but the system is not limited to those particular gases. In the embodiment shown in FIG. 12, the CO.sub.2 is shown as the gas used to insufflate an abdomen (or other area of a patient). The gas pressure control system 1200 has a 3-way proportional valve connected to the gas control module 1220. While FIG. 12 shows the 3-way proportional valve connected only to the CO2 control module 1220, the 3-way proportional valves could be connected to a different gas control module 1230 or 1240. The gas pressure control system 1200 further has an HF power module 1250 for supplying high frequency electrical energy for various types of electrosurgical procedures. The HF power module contains conventional electronics such as are known for provide HF power in electrosurgical generators. Exemplary systems include, but are not limited to, those disclosed in U.S. Pat. Nos. 4,040,426 and 4,781,175. The system further could have a converter unit for converting the HF power to a lower frequency, such as may be used for cold atmospheric plasma and is described in U.S. Patent Application Publication No. 2015/0342663.

(37) The outlet ports of gas control modules 1230, 1240 each are connected to tubing or other channel to a connector. Another connector 2152, 2172 connects to tubing 2150 that runs to and connects to tubing 1292. The tubing 1292 is connected to a pressure control valve or stopcock 1280 and extends into the trocar 1290. The pressure control valve 1280 is used to control pressure within the patient. The gas pressure control system further has a pressure sensor 1282 connected to the tubing 1292 to sense pressure in the tubing 1292 and a pressure sensor 1284 for sensing pressure in the pressure control valve 1280. The tubing 292 is actually tube within a tube such that gas supplied from the generator travels to the trocar and patient through one tube and gas is released out of the patient through a second tube.

(38) As shown in FIG. 12 the connector to which control module 1240 is connected has a gas-enhanced electrosurgical instrument 2170 having a connector 2172 connected to in. In FIG. 12, gas control module 1240 controls flow of helium gas, so the instrument 2170 is, for example, a cold atmospheric plasma attachment such as is disclosed herein.

(39) The system provides for control of intraabdominal pressure in a patient. The pressure control valve 1280 has a chamber within it. The pressure in that chamber is measured by pressure sensor 1284. CO.sub.2 is supplied to the chamber within pressure control valve 280 from gas control module 1220 via 3-way proportional valve 1260. Pressure in that chamber within the pressure control valve 1280 also may be released via 3-way proportional valve 1260. In this manner, the system can use the pressure sensor 1284 and the 3-way proportional valve to achieve a desired pressure (set through a user interface) in the chamber within the pressure control valve 1280. The pressure sensor 1282 senses the pressure in the tubing 1294 (and hence the intraabdominal pressure). The pressure control valve 1280 then releases pressure through its exhaust to synchronize the intraabdominal pressure read by sensor 1282 with the pressure in the chamber within the pressure control valve as read by pressure sensor 1284. The readings from sensors 1282, 1284 can be provided to CPU 1210, which in turn can control flow of CO.sub.2 and one of argon and helium, depending on the procedure being performed, to achieve a stable desired intraabdominal pressure.

(40) The foregoing description of the preferred embodiment of the invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed, and modifications and variations are possible in light of the above teachings or may be acquired from practice of the invention. The embodiment was chosen and described in order to explain the principles of the invention and its practical application to enable one skilled in the art to utilize the invention in various embodiments as are suited to the particular use contemplated. It is intended that the scope of the invention be defined by the claims appended hereto, and their equivalents. The entirety of each of the aforementioned documents is incorporated by reference herein.