WO2011137387A1

WO2011137387A1 - Gas and high frequency energy conducting and connecting apparatus and related method

Info

Publication number: WO2011137387A1
Application number: PCT/US2011/034650
Authority: WO
Inventors: Marcia L. Morris
Original assignee: Genii, Inc.
Priority date: 2010-04-30
Filing date: 2011-04-29
Publication date: 2011-11-03

Abstract

A single-use gas and high frequency energy conducting and connecting apparatus forms a connection between an electrosurgery generator and a gas source intended to produce gas enhanced electrosurgical effects, and an accessory.

Description

GAS AND HIGH FREQUENCY ENERGY CONDUCTING AND CONNECTING APPARATUS AND RELATED METHOD

PRIORITY OF INVENTION

This application claims priority to United States Provisional Application Number 61/329,666 that was filed on 30 April 2010. The entire content of this provisional application is hereby incorporated herein by reference. TECHNICAL FIELD

Apparatuses useful in gas enhanced electrosurgery.

BACKGROUND

Gas enhanced electrosurgery is commonly used in open, rigid and flexible endoscopic procedures. The advantages include the ability to produce broad surface as well as targeted hemostasis and ablation. High frequency energy of sufficient voltage is supplied by a high frequency electrosurgery generator and directed to a stream of gas. The gas becomes ionized which thereby allows for the transfer of energy to the tissue for therapeutic heating. The advantage is that the electrosurgical accessory does not have to come into direct contact with the target tissue. While any gas can potentially be ionized using adequate voltage, gasses most used medically include helium and argon.

Equipment currently in use for gas enhanced surgery includes a specially equipped electrosurgery generator, a gas source with appropriate regulation mechanisms, appropriate procedure specific applicators, handpieces, probes or accessories to interface with the patient tissue, and an appropriate conducting and connecting bridge device to deliver both the high frequency energy and the gas from the generator and gas source to the applicator, handpiece, probe or accessory.

When gas assisted electrosurgery is used, the gas and energy conducting and connecting bridge device is a reusable cord or hose with a hollow lumen and distal and proximal connectors. This reusable component is cumbersome and creates safety hazards in that if it is not cleaned and dried properly, inadvertent contamination can be transferred to the patient, especially when the gas begins to flow forward toward the patient. SUMMARY

A single use gas and high frequency energy conducting and connecting apparatus forms a conducting bridge and connection between an electrosurgery generator and a gas source intended to produce gas enhanced electrosurgical effects, and an applicator, handpiece, probe, or other accessory that will come between a patient and the apparatus. The apparatus has one or more openings at both the distal and proximal ends through which gas can enter and exit through the apparatus. The gas is conducted within the conducting portion of the apparatus by means of a hollow core consisting of one or more lumens. Throughout the length of the hollow core consisting of one or multiple lumens, an electrically conductive wire or wires is contained. The wire or wires may or may not be insulated. At the proximal end of the apparatus, a connecting terminus is installed to interface both with the high frequency energy from the generator and the source of the gas. At the distal end, there is a terminus that can interface and connect with, and deliver both the high frequency energy and the gas, to a separate accessory such as an applicator, handpiece, or probe that may be designed for single or multiple uses. These separate accessories, such as applicators, or handpieces, can include an array of commercially available gas enhanced surgical accessories, including, but not limited to, those designed to be used in flexible endoscopy, rigid endoscopy and open surgery. In one or more embodiments, the apparatus includes a valve uni-directional to fluid flow which prevents fluid flow from the distal portion to the proximal portion. In one or more embodiments, the apparatus is designed to be factory sterilize-able and sold as a single use device.

BRIEF DESCRIPTION OF THE FIGURES FIG. 1 A illustrates a side view of the apparatus constructed in accordance with at least one embodiment.

FIG. IB illustrates a proximal end view of the apparatus constructed in accordance with at least one embodiment.

FIG. 1C illustrates a distal end view of the apparatus constructed in accordance with at least one embodiment.

FIG. 2 A illustrates a perspective view of the apparatus constructed in accordance with at least one embodiment.

FIG. 2B illustrates a perspective view of the apparatus constructed in accordance with at least one embodiment.

FIG. 3 A illustrates an end view of a portion of the apparatus constructed in accordance with at least one embodiment.

FIG. 3B illustrates an end view of a portion of the apparatus constructed in accordance with at least one embodiment.

FIG. 4A illustrates an end view of the apparatus constructed in accordance with at least one embodiment.

FIG. 4B illustrates a side view of a portion the apparatus constructed in accordance with at least one embodiment.

FIG. 5 illustrates a view of the system using the apparatus.

DETAILED DESCRIPTION

The following detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the apparatus may be practiced. These embodiments, which are also referred to herein as "examples" or "options," are described in enough detail to enable those skilled in the art to practice the present invention. The embodiments may be combined, other embodiments may be utilized or structural or logical changes may be made without departing from the scope of the invention. The following detailed description is, therefore, not to be taken in a limiting sense and the scope of the invention is defined by the appended claims and their legal equivalents.

A system 200 includes a high energy source 202, such as electrical energy, and a gas source 204. A conduction and connection apparatus 100 is used between the high energy source, the gas source 202, 204 and an accessory 206 to be used within or on a patient, as shown in FIG. 5.

The conduction and connection apparatus 100, such as a single use flexible gas beam or plasma probe conducting and connecting device, includes a conductor housing 110 constructed of biocompatible and insulating material having an opening at the distal end portion and proximal end portion. The material for this device can be made of PTFE, PVC,

poloycarbonate, Santoprene, or combinations thereof. In an option, the conductor housing 110 is flexible. For instance, the conductor housing 110 can be made of shapes and/or materials that allow for the conductor housing 110 to be wrapped or formed around other components by bending the conductor housing 110 with human hands.

Referring to FIG. 1A, a conductor housing 110 extends between the proximal end connecting terminus 150 or proximal end portion and the distal end connecting terminus 160, or distal end portion. The proximal end portion is adapted to connect and/or connects to a high frequency energy generator, such as a source of electrical energy. The proximal end portion also is adapted to connect and/or connects to a gas supply, such as argon gas. The distal end portion connects with accessories, such as, but not limited to, applicators, handpieces, probes, or endoscopes. FIG. IB illustrates the gas and high frequency energy entry points in the proximal end connecting terminus 150, and FIG. 1C illustrates gas and high frequency exit points in the distal end connecting terminus 160.

Disposed within the housing 110 are one or more conduits. The conduit can include a gas conduit 10 and an electrical conduit. In an option, the gas conduit 10 is a hollow, and optionally flexible tube. The cross-sectional shape of the conduits can be circular, pie shaped, square, rectangular, triangular, pleated, fluted, octagonal or any other shape enabling a hollow core with one or multiple lumens. The gas conduit conveys gas from the proximal terminus 150 to the distal terminus 160. The electrical conduit includes one or more flexible electrically conductive wires 130. In an option, the electrical conduit is disposed within the gas conduit 10. In another option, the electrical conduit is independent from the gas conduit. The gas conduit as shown in FIGs. 2 A and 2B is a projecting conduit at one end, and a recessed conduit at the other end, allowing for connection with tubing of different shapes and sizes. In a further option, multiple electrical conduits are disposed within the housing 110, as shown in FIG. 2A.

In a further option, the electrical conduit includes one or more wires. These wires may be single, braided, twisted or aligned in any similar fashion and may be coated or insulated in order to prevent premature ionization of the gas. The wire material may be made of any number of types of conductive metal and the insulation may be a plastics material or coating, or any number of similar insulating materials suitable to the purpose. If used, the insulating coating 60 is applied outside the conductive wire 130. In an option, the insulating coating separates the conductive wire 130 from the lumen within the outer tube in which gas flows, thus separating the conductive wire 130 from the gas. In other embodiments, the conductive wire 130 may be carried through one lumen while the gas, separated, flows through a parallel lumen. The conductive wire 130 is connectable at the proximal end to the source of high frequency energy, and at least one lumen of the outer flexible tubing is designed to be connected to the source of the gas, both by way of a connecting terminus.

The proximal end connecting terminus 150 can be connected to the source of both the gas and the high frequency energy and may consist of either one single or two or more separate parts as shown in FIGs. 3 A and 3B. This connection may be designed in a shape or size that is convenient to and/or compatible with the type of electrosurgical generators) to which it may be attached. In the exemplary embodiments, the proximal end connecting terminus 150 has a gas entry point 10, a connector terminus housing 20 and a high frequency electrical energy conduit 30.

The distal end connecting terminus 160, opposite of the proximal end 114 of the apparatus 100, is designed with a connecting terminus that will accept an array of

commercially available accessories, such as gas enhanced surgical applicators, handpieces, probes, or accessories, including, but not limited to, those designed to be used in flexible or rigid endoscopy or open surgical procedures.

Referring to FIG. 4A and 4B, the conductor housing 110 has the function of being a conducting and connection portion of the apparatus 100. The conductor housing 110 surrounds a gas conduit, through which runs a high frequency conductive wire 130 that can be insulated with insulating coating 60. In certain embodiments, the conducting wire is a high frequency conducting wire. In one or more embodiments, gas is introduced into the apparatus by means of the gas entry point 10, and flows through the gas conduit.

In a further option, the apparatus includes a valve 140, such as a one-way, check valve.

The valve is uni-directional to fluid flow, may or may not be attached to the apparatus 100 between the proximal and distal termini, within or attached to the conducting conduit in one or more lumens. The valve 140 assists in preventing fluids from the patient to flow from the distal end portion toward the proximal end portion. The entire device is designed to be factory sterilize-able and sold as a single use device. In one embodiment the total length of the device is about 190 cm and the diameter of the outer flexible biocompatible and insulating tubing is less than 1cm. Other embodiments could have a total length of 20 cm to over 500 cm with outer tubing diameters between .3 cm to over 15 cm. However other embodiments may be of varying lengths and sizes. In an option, when the apparatus is used with flexible

endoscopes, no part of the current apparatus is intended to enter any of the working channels of the endoscope.

Additional examples of the embodiments are as follows. In a first example, a completely single-use gas and high frequency energy conducting and connecting apparatus that forms a conducting bridge and connection between an electrosurgery generator and a gas source intended to produce gas enhanced electrosurgical effects, and an applicator, handpiece, probe, or other device that may be single use or reusable. In combination with the first example, the apparatus can have a conducting portion that carries gas and high frequency energy between two, a distal and proximal, termini. This conducting portion has one or more openings at both the distal and proximal ends through which gas and high frequency energy can enter and exit through the conducting portion of the apparatus carrying both gas and high frequency energy between the termini.

In a further example, the apparatus can further include both a distal and proximal terminus. The proximal terminus serves to connect the conducting portion of the device to a high frequency energy source and a gas source while conducting both gas and high frequency energy to the conducting portion. The distal terminus serves to connect the conducting portion to an accessory such as an applicator, handpiece, probe, or other device which may be single use or reusable, and to conduct both gas and high frequency energy to the applicator, handpiece, probe, or other device. In an option, the entire apparatus is a single use, disposable product, for example, is manufactured to be inexpensive enough so that it can be a single use product. In a further example, in the apparatus as discussed above, the conducting portion of the apparatus contains one or more hollow lumens and which the overall cross sectional shape of the conducting portion may be circular, cylindrical, tubular, round, pleated, square, ridged, octagonal, helical, rectangular, or other shape that can provide the means to conduct gas and high frequency energy between termini.

In a further option, the apparatus includes wire or wires carrying high frequency energy through the conducting portion, and the wire may be insulated or un-insulated, and carried within one or more of one or multiple hollow lumens. The proximal terminus of the apparatus, in an option, is connected to the conducting portion and contains one or more sections attachable to both high frequency energy and gas sources and has openings, passage conduits, pegs or other types of attachments to conduct both high frequency energy and gas to the conducting portion. Still further, the distal terminus in an option is connected to the conducting portion and contains one or more sections attachable to an applicator, handpiece, probe, or other device that may be single or reusable and has openings, passage conduits, pegs or other types of attachments to conduct both high frequency energy and gas. In yet another example, the apparatus includes a uni-directional valve, such as a check valve, located between the termini. The valve prevents fluid from passing from the distal end portion or distal terminus to the proximal end portion or proximal terminus. This ensures patient fluids do not travel in that direction.

In a further embodiment, a method includes coupling a proximal end portion of an apparatus with high frequency energy supply and a gas supply, coupling a distal end portion of the apparatus with an accessory, and flowing both high frequency energy and gas from the proximal end portion to the distal end portion through a single conduit. In a further

embodiment, the method further includes preventing fluids from passing from the distal end portion to the proximal end portion.

While in the foregoing specification this invention has been described in relation to certain embodiments thereof, and many details have been set forth for purposes of illustration, it will be apparent to those skilled in the art that the invention is susceptible to additional embodiments and that certain of the details described herein may be varied considerably without departing from the basic principles of the invention.

The use of the terms "a" and "an" and "the" and similar referents in the context of describing the invention are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The terms "comprising," "having," "including," and "containing" are to be construed as open-ended terms (i.e., meaning "including, but not limited to") unless otherwise noted. Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., "such as") provided herein, is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention.

Embodiments of this invention are described herein, including the best mode known to the inventor for carrying out the invention. Variations of those embodiments may become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventor expects skilled artisans to employ such variations as appropriate, and the inventors intend for the invention to be practiced otherwise than as specifically described herein.

Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context.

Claims

1. A gas conduction and connection apparatus comprising:

a conductor housing;

the conductor housing having at least one gas conduit therein, the gas conduit extending from a distal to a proximal end of the conductor housing;

the conductor housing extending between a proximal terminus and a distal terminus, where the gas conduit fluidly couples the proximal terminus with the distal terminus, wherein the distal terminus is adapted to connect with at least one accessory; the proximal terminus is adapted to interface both with high frequency energy from a generator and a source of gas; and

a conductive wire adapted to conduct energy from the proximal terminus to the distal terminus.

2. The apparatus as recited in claim 1, further comprising a check valve disposed between the proximal terminus and the distal terminus, the check valve preventing fluids from flowing through the gas conduit from the distal terminus to the proximal terminus.

3. The apparatus as recited in claim 2, wherein the valve is a uni-directional valve.

4. The apparatus as recited in claim 1, wherein the conductive wire is disposed separate from the gas conduit.

5. The apparatus as recited in claim 1 , wherein the conductive wire is a braided wire.

6. The apparatus as recited in claim 1, wherein the conductive wire is a single wire.

7. The apparatus as recited in claim 1, wherein the conductive wire is a twisted wire.

8. The apparatus as recited in claim 1, wherein the conductive wire is insulated conductive wire.

9. The apparatus as recited in claim 1, wherein the accessory is an applicator.

10. The apparatus as recited in claim 1, wherein the accessory is a probe.

11. The apparatus as recited in claim 1, wherein the accessory is an endoscope.

12. The apparatus as recited in claim 1, wherein the accessory is a handpiece.

13. The apparatus as recited in claim 1, wherein the conductive wire is disposed within a wire conduit.

14. A method comprising:

coupling a proximal end portion of an apparatus with high frequency energy supply and a gas supply;

coupling a distal end portion of the apparatus with an accessory; and

flowing both high frequency energy and gas from the proximal end portion to the distal end portion through a single conduit.

15. The method as recited in claim 14, further comprising preventing fluids from passing from the distal end portion to the proximal end portion.