# Patent

## Title
Cold plasma annular array methods and apparatus

## Abstract

Methods and apparatus are described that use an array of two or more cold plasma jet ports oriented to converge at a treatment area. The use of an array permits greater tissue penetration by cold plasma treatments. This approach enables treatment of deeper infections of soft and hard tissues without surgical intervention. For example, this approach can treat sub-integumental infections, such as those common to joint replacements, without surgically opening the issues overlying the deeper infection.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a continuation of U.S. Non-Provisional application Ser. No. 14/145,312, filed Dec. 31, 2013, which claims the benefit of U.S. Provisional Application No. 61/747,428, filed Dec. 31, 2012 and entitled “Cold Plasma Toroidal Array Methods and Apparatus,” all of which are incorporated herein by reference in their entirety.
This application is related to U.S. Provisional Application No. 60/913,369, filed Apr. 23, 2007; U.S. patent application Ser. No. 12/038,159, filed Feb. 27, 2008 (which issued as U.S. Pat. No. 7,633,231); U.S. patent application Ser. No. 13/620,118, filed Sep. 14, 2012; and U.S. patent application Ser. No. 14/026,679, filed Sep. 13, 2013, each of which are herein incorporated by reference in their entireties.


BACKGROUND
Field of the Art
The present invention relates to devices and methods for cold plasma application, and, more particularly, to arrays of such devices that are formed in an annular shape and methods for using same.
Background Art
When infections of deep tissues occur in the body it is often necessary to perform a surgical procedure to expose the infection, manually clean or debride the site, pack it with antibiotics, and initiate systemic antibiotics in an attempt to resolve the infection. In the case of orthopedic infections, where there is hardware of metallic or plastic composition present, the standard course of treatment may require multiple surgical procedures. Since the hardware may be covered in bacterial colonies and there is limited vascularization of the tissues immediately contacting the hardware, the colonization of the hardware often can't be controlled with systemic antibiotic use alone. In the case of an infected total joint replacement, the surgeon will often perform a “two-stage revision” procedure. The first stage involves opening the joint, removing the hardware, debriding infected tissue, packing the region with antibiotic impregnated materials, and closing the incision. Along with systemic antibiotics, the antibiotic materials are left in the patient, often with a non-functional joint complex, for on average 6 weeks. After blood and joint fluid tests suggest resolution of the infection, a second procedure is performed to remove the antibiotic laden materials and implant a new functional joint replacement. In some cases the infection is still present locally even though blood indicators are normal, and the new implant may quickly become re-infected, starting the “2-stage revision” procedure over again. In extreme cases, amputation may be the prescribed course of action for severe extremity infections that fail to resolve after these measures.
It is therefore highly desirable to be able to eradicate a deep joint infection without the need for repeated surgeries and a reliance on antibiotics to reach the site either through the circulatory system or by local, internal, long-term application. The same applies to other bone and deep tissue infections, abscesses, and similar conditions familiar to those in the medical field. As cold plasmas also show promise in the treatment of malignant growths, this array would have use in the treatment of deep tissue tumors, or any disorder that requires greater depth of penetration of plasma, including musculoskeletal pain and inflammation.
BRIEF SUMMARY OF THE INVENTION
An embodiment is described of an apparatus having an annular structure with two or more cold plasma devices located on the annular structure and directed internal to the annular structure so as to converge at a treatment area. The two or more cold plasma devices are coupled to one or more high voltage RF ports and to one or more gas supply ports.
A further embodiment is described of a method of producing cold plasma for use in a medical treatment. The method includes receiving, from a cold plasma power supply, electrical energy at two or more cold plasma devices via one or more high voltage RF ports. The two or more cold plasma devices are located on an annular structure. The method also includes receiving, from a gas source, gas at the two or more cold plasma devices via one or more gas supply ports. Finally, the method includes outputting cold plasma from the two or more cold plasma devices, the cold plasma from these cold plasma devices being directed to converge at a treatment area.



BRIEF DESCRIPTION OF THE DRAWINGS/FIGURES
FIG. 1 illustrates an embodiment of the cold plasma annular treatment device that includes an array of a plurality of plasma ports.
FIG. 2 illustrates an embodiment that provides an adjustable four-port array of a plurality of cold plasma ports in an annular orientation.
FIG. 3 illustrates an embodiment of a four-port, adjustable array (in a closed position) of a plurality of cold plasma ports in an annular orientation.
FIG. 4 illustrates an embodiment where two cold plasma ports are positioned to be diametrically opposed to one another, with convergence of the resulting cold plasma jets occurring between the two cold plasma ports.
FIG. 5 illustrates a flowchart of a method for providing two or more cold plasma jets that converge at a treatment area, according to an embodiment of the present disclosure.



DETAILED DESCRIPTION OF THE INVENTION
Cold temperature plasmas have attracted a great deal of enthusiasm and interest by virtue of their provision of plasmas at relatively low gas temperatures. The provision of plasmas at such a temperature is of interest to a variety of applications, including wound healing, anti-bacterial processes, tumor treatments, anti-inflammatory treatments, non-infective disorders that may be treatable with cold plasmas, and various other medical therapies and sterilization.
Conventional cold plasma treatments were focused on treatment areas at the surface of the skin, as it was not previously known that cold plasmas could penetrate the surface of the skin. Consequently, no contemplation was previously considered as to approaches by which cold plasma penetration for treatment purposes could be improved or optimized. However, recent data that is described in U.S. patent application Ser. No. 14/026,679, entitled “Therapeutic Applications of Cold Plasma,” filed Sep. 13, 2013, indicate that subcutaneous treatment protocols are feasible with cold plasmas. In particular, paragraphs [0084]-[0089] of this referenced application provide data in support of the proposition that cold plasma penetrates beneath the skin so that internal tissue treatments are feasible.
Consideration of the penetration effects of cold plasma indicates that the penetration can be thought of as a cone of attenuation below the skin surface. The cold plasma intensity decreases due to the spreading effect associated with the conical penetration shape below the skin surface. It is therefore desirable to be able to increase the penetration and/or to increase the intensity at various depths below the surface of the skin. By generating multiple “cones” of treatment in the tissues, with some degree of overlap, the desirable effects in deep tissues can be amplified. Therefore, increasing the intensity at various targeted depths below the skin surface, the volumetric problem of certain internal tissues disorders can be addressed.
Embodiments of the present disclosure include an annular device designed with an array of two or more individual cold plasma (CP) jet ports oriented to converge about a patient's body segment (either at the skin surface or below the skin surface) resulting in a plurality of treatment angles (FIG. 1). The effective penetration of a typical cold plasma jet is generally on the order of <2 cm. By arranging a plurality of jets circumferentially around the desired treatment zone, penetration to deeper tissues is possible and more complete. Embodiments of the cold plasma annular treatment device can be used to treat sub-integumental infections, such as abscess, bone, and joint infections, without surgically opening the tissues overlying the deeper infection. The ability to treat deep infections of the soft and hard tissues of the body without surgical intervention greatly reduces the risk of secondary complications (comorbidities), reduces pain, and decreases the cost of treating these infections. Other beneficial applications of cold plasma, such as treating tumors or musculoskeletal disorders would also benefit from improved penetration.
The device, designed similarly to a modern magnetic resonance imaging (MRI) machine, allows the patient's injured or infected segment to be placed inside of the machine, which is designed in an annular shape to surround the affected area. FIG. 2 illustrates an adjustable symmetrical array of cold plasma ports surround the segment to apply a treatment of the desired duration and intensity. The array could consist of any number of ports (FIG. 1, for example, illustrates 4 ports, but two or more ports are contemplated to be within the scope of the present disclosure) to expand the degree of coverage of treatment through an overlapping and/or converging plurality of plasma jets. The annular array could be molded in unique sections, such as four sections (FIG. 2) and assembled after manufacture. The ports themselves can be designed and manufactured to each provide a cold plasma jet, using any approach known to one skilled in the art. As an example (which is not intended to be limiting), the cold plasma jet sources may be the multi-frequency harmonic-rich cold plasma (MFHCP) devices described in U.S. Provisional Patent Application No. 60/913,369, U.S. Non-provisional application Ser. No. 12/038,159 (that has issued as U.S. Pat. No. 7,633,231) and the subsequent continuation applications (collectively “the '369 application family”), which are incorporated herein by reference. Included in the description in U.S. Pat. No. 7,633,231 are devices that form cold plasma without the use of internal ground electrodes. Furthermore, the high voltage RF power supply may be (but not limited to) that described in the '369 patent family, or in U.S. patent application Ser. No. 13/620,118, filed Sep. 14, 2012, which is also incorporated herein by reference. In both the cold plasma device and high voltage RF power supply, the scope of this invention is not limited to these particular examples, but covers all cold plasma devices and high voltage RF power supplies.
On the cold plasma annular treatment device, the devices would be activated remotely by a common trigger mechanism to generate plasma. This common trigger mechanism could be a physical flow control or a computer console that triggers a plurality of valves and RF energy. The devices would be affixed to the annular array, as illustrated for example in FIG. 1.
FIG. 1 illustrates an embodiment of the cold plasma annular treatment device that includes a symmetrical array of a plurality of plasma ports. In this embodiment, four (4) ports 120a, 120b, 120c, 120d are illustrated, although two or more ports falls within the scope of various embodiments of the present invention. Attached to each port is a cold plasma generation unit 110a, 110b, 110c, 110d with the plasma flow directed as shown to converge at an interior region. Each cold plasma generation unit 110 is connected by a high-voltage RF feed cable 160 to one or more high voltage RF power supplies 150, and a gas supply line 130 to a suitable supply of gas 140. The cold plasma annular treatment structure can be modified to fit the appropriate size permitted by the each of the plasma ports, as well as the intended treatment area. A sliding/locking mechanism 170 is illustrated that allows the cold plasma annular treatment structure to expand or contract as necessary to make the appropriate physical accommodation. The high voltage RF power supplies can be similar to those described in the '369 application family.
FIG. 2 illustrates an embodiment that provides an adjustable four-port array of a plurality of cold plasma ports 220 in an annular orientation. Since the distance between the plasma outlet port and treatment target are critical for effective treatment and tissue penetration, the internal treatment area of the array can be adjusted to optimize the distance between the plasma outlet ports and the target area (e.g., a patient's body segment) undergoing treatment. Sliding/locking mechanism 170 may be in an open position 210, or in a closed position 230. Sliding/locking mechanism 170 makes use of an adjustment track 240. The array can be expanded or contracted as needed, and locked into place to ensure consistent and optimized treatment distances. As can be readily surmised by an examination of the Figures, the array can be adjusted in one direction, or in a second direction. The second direction can be orthogonal, or at another suitable angle, to the first direction. Such adjustment directions are merely exemplary, and serve to illustrate the flexibility of adjustment envisaged for various embodiments within the scope of the present invention.
FIG. 3 illustrates an embodiment of a four-port, adjustable symmetrical array (in a closed position using sliding/locking mechanism 310) of a plurality of cold plasma ports in an annular orientation. Although FIG. 3 illustrates the possibility of four ports, only two ports 320a, 320b are occupied for this particular treatment regime. As expected, cold plasma 330a, 330b emanates and converges to a treatment area (not shown). In this embodiment, the two cold plasma sources are on the same side of the treatment area.
In the context of this application, an annular cold plasma structure includes the scenario where two cold plasma ports are aligned diametrically opposed to one another, with a treatment area located in between the two cold plasma ports to receive cold plasma from those two cold plasma ports. FIG. 4 illustrates such an embodiment, with cold plasma devices 430a, 430b positioned to be diametrically opposed to one another. Each cold plasma device 430 receives a source of electrical energy via high voltage RF feed line 420 and gas via gas feed line 410. Cold plasma 440a, 440b emanates from cold plasma devices 430a, 430b to reach treatment area (not shown) that is in between cold plasma devices 430a, 430b. 
FIG. 5 provides a flowchart of a method for providing two or more cold plasma jets that converge at a treatment area, according to an embodiment of the present disclosure.
The process begins at step 510. In step 510, electrical energy is received at two or more cold plasma devices, wherein the cold plasma devices are located on an annular structure.
In step 520, gas is received at the two or more cold plasma devices.
In step 530, cold plasma is output from the two or more cold plasma devices so as to converge at a treatment area.
At step 540, method 500 ends.
Although the above description has used the '369 application family as the baseline cold plasma device, the scope of the present invention is not limited to the '369 application family baseline. The '369 application family baseline is merely exemplary and not limiting, and therefore embodiments of the present invention include the deployment of the above annular features to cold plasma generation devices in general, irrespective of their means of generation.
As noted above, the four-port configuration is exemplary, and not a limiting of various embodiments of the present invention. Other numbers of ports fall within the scope of various embodiments of the present invention. Further, although a symmetric configuration is described above, non-symmetric or asymmetric configurations of ports can also be used to provide a particular treatment protocol, and such non-symmetric/asymmetric configurations also fall within the scope of various embodiments of the present invention.
It is to be appreciated that the Detailed Description section, and not the Summary and Abstract sections, is intended to be used to interpret the claims. The Summary and Abstract sections may set forth one or more but not all exemplary embodiments of the present invention as contemplated by the inventor(s), and thus, are not intended to limit the present invention and the appended claims in any way.
The present invention has been described above with the aid of functional building blocks illustrating the implementation of specified functions and relationships thereof. The boundaries of these functional building blocks have been arbitrarily defined herein for the convenience of the description. Alternate boundaries can be defined so long as the specified functions and relationships thereof are appropriately performed.
The foregoing description of the specific embodiments will so fully reveal the general nature of the invention that others can, by applying knowledge within the skill of the art, readily modify and/or adapt for various applications such specific embodiments, without undue experimentation, without departing from the general concept of the present invention. Therefore, such adaptations and modifications are intended to be within the meaning and range of equivalents of the disclosed embodiments, based on the teaching and guidance presented herein. It is to be understood that the phraseology or terminology herein is for the purpose of description and not of limitation, such that the terminology or phraseology of the present specification is to be interpreted by the skilled artisan in light of the teachings and guidance.
The breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following claims and their equivalents.

## Claims

1. An apparatus comprising:
an annular structure having two or more cold plasma devices positioned to provide converging cold plasma jets that converge at a treatment area, wherein at least one of the two or more cold plasma devices is coupled to one or more harmonic high voltage RF power supplies.

2. The apparatus of claim 1, wherein the two or more cold plasma devices are positioned in a circumferential orientation.

3. The apparatus of claim 1, further configured to include a plurality of port locations, wherein the two or more cold plasma devices occupy a subset of the plurality of port locations.

4. The apparatus of claim 1, wherein the annular structure is adjustable, the annular structure being further configured to be lockable to ensure a predetermined alignment of the two or more cold plasma devices.

5. The apparatus of claim 1, wherein the two or more cold plasma devices are configured to generate two or more cold plasma jets that are diametrically opposed to one another, the treatment area being located between the two or more cold plasma devices.

6. The apparatus of claim 1, wherein the two or more cold plasma devices are coupled to a common triggering mechanism to simultaneously activate the two or more cold plasma devices.

7. The apparatus of claim 1, wherein functionality settings of the two or more cold plasma devices are independently configurable to provide a desired treatment regime at the treatment area.

8. The apparatus of claim 7, wherein the functionality settings of the two or more cold plasma devices include computer control.

9. The apparatus of claim 1, wherein at least one of the two or more cold plasma devices is a multi-frequency harmonic-rich cold plasma device.

10. The apparatus of claim 1, wherein at least one of the two or more cold plasma devices is free of internal ground electrodes.

11. A method comprising:
receiving, from one or more high voltage RF power supplies, electrical energy at two or more cold plasma devices, wherein the two or more cold plasma devices are located on an annular structure;
receiving, from a gas source, gas at the two or more cold plasma devices; and
outputting cold plasma from the two or more cold plasma devices to converge at a treatment area.

12. The method of claim 11, wherein the two or more cold plasma devices are located in a circumferential orientation.

13. The method of claim 11, wherein the annular structure includes a plurality of port locations, and wherein the two or more cold plasma devices occupy a subset of the plurality of port locations.

14. The method of claim 11, wherein the annular structure is adjustable, the method further including:
locking the adjustable annular structure to ensure a predetermined alignment of the two or more cold plasma devices.

15. The method of claim 11, wherein outputting cold plasma from the two or more cold plasma devices includes outputting cold plasma in jets that are diametrically opposed to one another, the treatment area being located between the two or more cold plasma devices.

16. The method of claim 11, wherein the two or more cold plasma devices are coupled to a common triggering mechanism to simultaneously activate the two or more cold plasma devices.

17. The method of claim 11, wherein functionality settings of the two or more cold plasma devices are independently configurable to provide a desired treatment regime.

18. The method of claim 17, further including:
computing controlling the functionality settings of the two or more cold plasma devices.

19. The method of claim 11, wherein at least one of the two or more cold plasma devices is a multi-frequency harmonic-rich cold plasma device, and outputting cold plasma includes outputting multi-frequency harmonic-rich cold plasma.

20. The method of claim 11, wherein receiving electrical energy at two or more cold plasma devices includes receiving electrical energy at at least one of the two or more cold plasma devices, wherein the at least one of the two or more cold plasma devices is free of internal ground electrodes.