RU2793811C2 - Microwave applicator for cervix - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: devices and a method of using a microwave antenna device, which comprises an electrically conductive grounding element forming a hole, an electrically conductive elongated element passing through the hole and ending at the distal end, and one or more dielectric elements. One or more dielectric elements electrically isolate the elongated element and the grounding element from each other. The microwave antenna device may be configured, upon application, to radiate microwave energy into the surface tissue of the cervix so as to provide a therapeutic effect in one or more areas of the cervix, such as one or more areas of the cervix infected with human papillomavirus (HPV), and/or where the cervical intraepithelial neoplasia (CIN) is diagnosed, or in order to create the correct biological response in one or more such areas. The microwave antenna device may be configured with a possibility of localized non-ablative hyperthermia of the surface tissue of the cervix, localized ablation of the surface tissue, and/or cauterization of the surface tissue of the cervix.

EFFECT: possibility of localized non-ablative hyperthermia of the surface tissue of the cervix, localized ablation of the surface tissue, and/or cauterization of the surface tissue of the cervix.

43 cl, 29 dwg

Description

The field of technology to which the invention belongs

The present invention relates to a microwave antenna device or applicator, microwave apparatus and microwave system for use in the irradiation of microwave energy to superficial tissues of the cervix, in particular, but not exclusively, for use in the treatment of epithelial diseased tissues or conditions affecting tissues, such as cervical neoplasia. uterus. The present invention also relates to methods for making a microwave antenna device or applicator and to methods for irradiating microwave energy to cervical surface tissue using a microwave antenna device or applicator.

State of the art

It is known to use microwave applicators to irradiate the surface tissue of the cervix with microwave energy to promote heating and activate biological effects in the surface tissue of the cervix. The exact nature of these biological effects is yet to be determined, but it may be that heat is not solely responsible for certain biological reactions, their magnitude, or the time required for biological reactions to occur. The thermal effect is observed when the tissue temperature is in the range of 40°C to 50°C. Without being limited by theory, it is believed that non-ablative microwave energy can activate certain interferon-regulated enzymes such as 2'-5'-oligoadenylate synthetase. It is an antiviral enzyme that counteracts viral attack by destroying viral and host RNA. This enzyme uses ATP (adenosine triphosphate) in 2'-specific nucleotidyl transfer reactions to synthesize 2'-5'-oligoadenylates, which activate latent ribonuclease (RNASEL), promoting degradation of viral RNA and inhibition of viral replication. Upregulation of RNASEL can be used to therapeutically address selective toxicity against immortalized E6/E7 keratinocytes present in cervical tissues as one of the non-ablative treatments.

Another limitation of microwave antenna implementation is that any air gap between the dielectric and the target tissue can affect microwave performance if it is not sufficiently considered in the design and controlled during manufacture by tuning. Air gaps also allow high order modes to be formed and in high power applications can create a source of breakdown causing sparking and burning of the electrode. The effect of air gaps is especially important if the relative permittivity or relative epsilon (Er) value of the dielectric is much larger than that of the surrounding air (Er 1), for example, in fabrics with a high dielectric constant Er 20 Er 40 Er 70, etc.

The dielectric properties of the target tissue are a factor in determining the power required to achieve the biological response and the temperature range (40°C to 50°C). The electrical conductivity of tissues is another factor. Thus, the required energy range varies and can be adjusted by changing the combination of power (0.1 to 20 W) and time (0.1 to 30 s).

Cervical intraepithelial neoplasia (CIN) is a common precancerous condition of the cervix associated with the human papillomavirus (HPV) that can occur in anyone, but usually occurs in young women who want to preserve their fertility, and treatment often includes surgical removal way. The lesion can exist at any of three stages: CIN1, CIN2 or CIN3 depending on the degree of dysplasia: CIN1 - the smallest (mild), CIN2 (moderate) and CIN3 - the highest (severe). Collectively, CIN2+ refers to CIN2 (moderate) and CIN3.

In line with the World Health Organization (WHO) guidelines on screening and treatment of precancerous lesions for the prevention of cervical cancer: Supplementary Resources: GRADE Symptom and Recommendation Tables and symptom profiles for each recommendation, 2013, WHO standard practice is to screen women using cytology. examination (Pap smear), and with a positive cytological examination, the diagnosis of CIN is made on the basis of subsequent colposcopy, biopsy of suspicious lesions, and then treatment is carried out only after histological confirmation of CIN2+. CIN2+ can progress to invasive cervical cancer within 10-20 years.

The cervix is the lower cylindrical distal part of the uterus and is divided into 2 regions: ectocervix and endocervix. The ectocervix is visible when viewed with a mirror. Endocervix (or endocervical canal) is a lumen inside the cervix, forming a passage between the vaginal cavity and the internal os of the cervix. The upper border of the endocervical canal is called the internal os or isthmus and marks the transition from the endocervix to the endometrium.

Although the initial infection can occur anywhere in the cervix, the cause of subsequent dysplasia occurs in an area where two different types of cells meet: columnar and squamous epithelium. This connection moves from pre-puberty to post-puberty and leaves a "zone of transformation".

In the type 1 (T1) transformation zone of CIN, only the lower outer surface of the ectocervical region is affected by neoplasia; it is completely visible for inspection without any manipulation. In the transformation zone type 2 (T2) CIN, there is a combination of ectocervical and endocervical areas with neoplasia, which is also visible without any manipulation. In the type 3 (T3) CIN transformation zone, there is a further expansion of the endocervical component that goes beyond visibility when manipulated to visually expose 3 mm of the pharynx.

CIN can be treated with cervical surgery, either by removal through surgical excision or by destroying the cells covering the cervix, for example, with ablative therapies such as: laser therapy, heat or freezing, thermo- and cryotherapy. Although it is effective in most cases, surgery can cause immediate unwanted effects such as bleeding and infection, or later complications, including difficulty with menstruation due to cervical scarring and early (premature) delivery.

Loop cervical electroconization (LEEP) is a common surgical invasive procedure for the treatment of high grade cervical precancerous lesions (CIN2+). LEEP is performed with the woman lying on her back, legs in stirrups, buttocks at the bottom edge of the table (supine lithotomy position). A speculum is placed in the vagina and a binocular or monocular illuminated microscope (colposcope) is focused on the cervix. In different geographic regions, LEEP is also known as Transformation Zone Excess Loop Excision (LLETZ).

LEEP interventions carry a significant risk of consequences. Of those treated with LEEP, 67% complain of pain, 86% of bleeding (2 to 8 weeks after the intervention) and 65% of discharge - see TOMBOLA (Trial Of Management of Borderline and Other Low-grade Abnormal) group smears), “After-effects reported by women following colposcopy, cervical biopsies and LLETZ: results from the TOMBOLA trial”, BJOG: An International Journal of Obstetrics & Gynaecology, 116: 1506-1514, 2009. Subsequent cauterization of the area treated with LEEP, may affect the frequency of delayed bleeding and contribute to the onset of pain in patients. The most common method of cauterization is monopolar diathermy, in which a pad is placed under the patient's buttocks to form a fixed electrode. The second electrode is placed at the desired cauterization site where the energy is concentrated on a small surface area of the surgical instrument. The electrical circuit is closed by passing current through the patient's body. This secondary treatment as part of the LEEP treatment can result in electrical shock and burns to the patient, causing additional discomfort - see Cheney F.W., Posner K.L., Caplan R.A., Gild W.M. “Burns from warming devices in anesthesia: A closed claims analysis,” Anesthesiology, 80(4), pp. 806-810, 1994.

About 10% of those who have been treated go to their doctor either for reassurance or for antibiotics if an infection is suspected. Subsequent changes also include 70% of menstrual irregularities. Changes in the patient's lifestyle for up to 6 weeks also include not having sex or using tampons.

LEEP as a treatment for CIN is reported to be 86% to 98% effective at 14 months of follow-up - see Boonlikit, S. and Srichongchai, H., “Comparison of Recurrence Rates with Contour-Loop Excision of the Transformation Zone (C -LETZ) and Large Loop Excision of the Transformation Zone (LLETZ) for CIN,” Asian Pacific Journal of Cancer Prevention, 15(15), pp. 6005-6008, 2014. Over a longer period of 5 years, efficiency can be as low as 43% - see Flannelly, G., Bolger, B., Fawzi, H., Lopes, A. and Monaghan, J.M., “Follow up after LLETZ: could schedules be modified according to risk of recurrence?”, BJOG: An International Journal of Obstetrics & Gynaecology, 108(10), pp. 1025-1030, 2001. Destruction of diseased tissue is the goal of LEEP intervention. The HPV virus is still present in 22% of patients after the procedure and is a contributing factor to poor overall performance. This rate is similar to the recurrence of warts, another manifestation of HPV infection after surgery, and a 30% recurrence rate - see Lipke, M.M., “An armamentarium of wart treatments,” Clinical Medicine & Research, 4(4), pp. 273-293, 2006. HPV particles released during the intervention may also be a contributory factor, as is the presence of HPV in the gas plume created by the LEEP procedure, similar to laser ablation techniques, which also require extraction - see Sood, A.K., Bahrani-Mostafavi , Z., Stoerker, J. and Stone, I.K., “Human papillomavirus DNA in LEEP plume,” Infectious Diseases in Obstetrics and Gynecology, 2(4), pp. 167-170, 1994.

Cryotherapy, also known as cryosurgery and cryoablation, uses extreme cold to destroy tissue. In cells below a certain temperature, ice crystals form and cause rupture of the cell membrane, irreversibly damaging it, thereby killing the cell. The low temperature source can be liquid nitrogen or other gases and can be injected through a needle to localize the effect. Strict health and safety regulations are in place to prevent accidental damage to other patient or operator tissues. An additional side effect of this process is often scarring.

Laser therapy is an alternative method of ablation, which can, for example, use a focused CO ₂ laser to burn tissue before it is destroyed. This is a highly localized method, although the depth of penetration is much less than with cryotherapy. Evaporation produces an aerosol or plume that must be removed to prevent secondary infections in the patient and operator. The power of the laser means destruction occurs in seconds, which can lead to accidents due to misdirecting the laser to healthy tissue or the operator's hand. Further operational risks arise from the ability of the laser to bounce off reflective surfaces, resulting in the procedure being performed only under specialized conditions.

Microwave energy is known to be used to treat tissue infected with HPV. It has been shown that microwave energy can easily penetrate deep into the layers of the epidermis towards the dermis. The HPV virus is known to reside in the stratum basale and replicate in the stratum spinosum and stratum granulosa. Similarly, the layers of the cervical epithelium also contain HPV particles in the basal layer when infected after abrasion in the upper squamous epithelium.

Disclosure of the essence of the invention

One skilled in the art should understand that any features of any of the devices, apparatuses, systems, or methods described herein may be applied alone or in any combination to any other device, apparatus, systems, or methods described herein. .

This document describes a microwave antenna device designed to radiate microwave energy into the surface tissue of the cervix, comprising:

an electrically conductive grounding member defining a hole;

electrically conductive elongated element passing through the specified hole and ending at the distal end; And

one or more dielectric elements,

wherein one or more dielectric elements electrically isolate the elongated element and the grounding element from each other.

A microwave antenna device can be used to deliver microwave energy to selected areas of the cervix, such as selected areas of the cervix that have previously been identified as exhibiting cervical intraepithelial neoplasia (CIN).

The grounding element and the elongated element may be coaxial. This can improve the efficiency of transmitting microwave energy through the microwave antenna device to the surface tissues of the cervix.

One or more dielectric elements may form an outer surface to interact with the surface of the cervix.

One or more dielectric elements may cover the distal end of the elongated element.

One or more dielectric elements may cover the distal portion of the elongate element.

The elongated member may extend axially beyond the grounding member for a predetermined length, and one or more dielectric members may cover a portion of the predetermined length of the elongate member.

The elongated element may extend axially beyond the grounding element for a predetermined length, and one or more dielectric elements may cover the entire predetermined length of the elongated element.

The one or more dielectric elements may be configured to prevent the elongate element from contacting the surface of the cervix when using the microwave antenna device. This can help avoid burning or charring of the tissue on the surface of the cervix.

One or more dielectric elements may be configured to separate the grounding element and/or the elongated element from the surface tissue of the cervix by a desired predetermined distance. For example, one or more dielectric elements may have a desired predetermined thickness.

One or more dielectric elements may fill the hole formed by the ground element.

One or more dielectric elements may define a central distal element for centering the antenna about the axis of the cervical os.

The central distal member may be configured to radiate microwave energy into the proximal cervical os.

One or more dielectric elements may form a cup-shaped element to cover the proximal portion of the cervical ectocervix and prevent excessive insertion of the central distal element into the cervical os.

The microwave antenna device may include an electrically conductive cap at or near the distal end of the elongated conductor. For example, the distal end of the outer surface of the microwave antenna device may be defined by one or more dielectric elements, and the cap may be positioned between the distal end of the elongate conductor and the distal end of the outer surface of the microwave antenna device. Alternatively, the cap may define the distal end of the outer surface of the microwave antenna device.

One or more dielectric elements may cover at least a portion of the ground element. This may prevent the grounding element from contacting the surface of the cervix when using a microwave antenna device. This can help avoid burning or charring of the tissue on the surface of the cervix.

One or more dielectric elements may cover at least a portion of the distal surface of the ground element.

One or more dielectric elements may cover at least a portion of the distal surface of the ground element.

The microwave antenna device can determine the axis. For example, the microwave antenna device may be cylindrically symmetrical about an axis.

The elongated element may protrude axially beyond the grounding element by a predetermined length, such as a predetermined length less than or equal to 50 mm, from 5 to 15 mm, or substantially equal to 10 mm.

The elongated element may be rod-shaped. The elongated element may be cylindrical. The elongated element may be tapered.

The radial extent of the grounding element may be greater or less than the radial extent of the dielectric element by a given radial displacement. The radial displacement may be less than or equal to 20 mm, greater than or equal to 10 mm, or greater than or equal to 5 mm.

The grounding element may be annular or generally annular. The grounding element may be flat or generally flat. The grounding element may be curved. The grounding element may be cup or bowl shaped with the cup or bowl opening oriented toward the distal end of the elongated element. The grounding element may be in the form of an inverted cup or inverted cup with the inverted cup or inverted cup opening oriented away from the distal end of the elongated element.

The elongated element may include a proximal portion on the side of the grounding element opposite the distal end of the elongated element.

The grounding element may comprise a body part and an external conductive part, while the external conductive part extends away from the body part, on the opposite side of the body part, to the distal end of the elongated element, and while the outer conductive part of the grounding element is located coaxially with the proximal part of the elongated element . The microwave antenna device may include an electrical connector, such as a coaxial electrical connector, wherein the electrical connector is electrically connected to the outer conductive portion of the grounding element and to the elongated element.

The microwave antenna device may include an outer conductor electrically connected to and extending from the grounding element on the opposite side of the grounding element to the distal end of the elongated element, and the outer conductor is located coaxially with the proximal part of the elongated element. The outer conductor may be soldered or welded to the earth element, the outer conductor may be electrically connected to the earth element using a conductive epoxy resin, and/or the outer conductor and the earth element may be mechanically connected, such as by pressing. One or more dielectric elements can electrically isolate the outer conductor and the elongated element from each other. The microwave antenna device may comprise an electrical connector, such as a coaxial electrical connector, wherein the electrical connector is electrically connected to the outer conductor and to the elongated member.

The microwave antenna device may be configured to provide a desired predetermined radiation pattern for one or more predetermined microwave energy characteristics when the microwave antenna device is located at a distance from any other object such that the desired predetermined radiation pattern is not disturbed by the proximity of any other object.

The microwave antenna device may be configured to provide a desired predetermined radiation pattern for one or more predetermined microwave energy characteristics when the microwave antenna device is located away from the cervical surface such that the desired predetermined radiation pattern is not disturbed by the proximity of the cervical surface.

The microwave antenna device may be configured to provide a desired predetermined radiation pattern for one or more predetermined microwave energy characteristics when the microwave antenna device is used to expose the cervix to microwave energy.

The microwave antenna device may be configured to provide a desired therapeutic effect for one or more specified microwave energy characteristics when the microwave antenna device is used to apply microwave energy to the cervix.

The microwave antenna device may be configured to generate the correct biological response for one or more specified microwave energy characteristics in one or more areas, such as one or more infected areas, of the cervix.

The microwave antenna device may have a relative permittivity that matches or substantially matches that of cervical tissue for one or more given microwave energy characteristics. This can improve the efficiency of microwave energy transfer to the cervical tissue. This can significantly reduce the risk of heating of the microwave antenna device itself and thus reduce the risk of accidental tissue burn if the antenna touches any adjacent tissue immediately after treatment.

The microwave antenna device may have a relative dielectric constant that differs by less than 50%, less than 10%, less than 1%, or less than 0.1% from the relative dielectric constant of the cervical tissues for one or more specified microwave characteristics. energy.

The microwave antenna device may be configured to induce local non-ablative hyperthermia of the cervical surface tissue for one or more specified microwave energy characteristics.

The microwave antenna device may be configured to generate a biological response in one or more regions of the superficial tissue of the cervix infected with human papillomavirus (HPV) and/or diagnosed with cervical intraepithelial neoplasia (CIN) for one or more specified microwave energy characteristics.

The microwave antenna device may be configured to cause local ablation of the surface tissue of the cervix for one or more predetermined microwave energy characteristics.

The microwave antenna device may be configured to cauterize the surface tissue of the cervix for one or more predetermined microwave energy characteristics.

One or more specified characteristics of microwave energy may include at least the following: frequency, frequency spectrum, power, power density, energy, energy density, intensity, intensity, amount, amplitude, exposure time, dose, pulse duration, and pulse repetition rate of microwave energy. .

The one or more specified microwave energy characteristics may comprise a frequency in the range of about 500 MHz to about 200 GHz, in the range of about 900 MHz to about 100 GHz, or in the range of about 5 GHz to about 15 GHz.

One or more specified characteristics of microwave energy may contain a frequency of about 8 GHz.

One or more specified microwave energy characteristics may comprise a power from 0.1 W to 20 W.

The one or more preset microwave energy characteristics may comprise an exposure time in the range of 0.1 s to 30 s.

The microwave antenna device may be configured to provide a predetermined radiation pattern for irradiating one or more predetermined regions of the surface tissue of the cervix. The microwave antenna device may be configured to provide a radiation pattern for irradiating one or more ectocervical regions of the surface tissue of the cervix. The microwave antenna device may be configured to provide a radiation pattern for irradiating one or more endocervical regions of the surface tissue of the cervix.

The microwave antenna device may be disposable or reusable.

The microwave antenna device may include a microwave applicator.

Any number of any of the microwave antenna devices described above may be provided, with each microwave antenna device having a different configuration selected to provide a corresponding different radiation pattern. Radiation patterns, for example, may be selected to irradiate one or more appropriate ectocervical and/or endocervical areas of the cervical surface tissue.

The microwave antenna device may have a different outer surface configuration. For example, the microwave antenna device may have external surfaces of various shapes and/or sizes. The microwave antenna device may have elongated elements and/or ground elements of a different configuration.

The one or more dielectric materials may include any one or more of the following: acrylonitrile butadiene styrene (ABS), nylon, polyethylene terephthalate (PET), polyimide, polypropylene, and polytetrafluoroethylene (PTFE).

This document describes a microwave apparatus for use in radiating microwave energy to the surface tissues of the cervix, the microwave apparatus comprising a rod connected to any of the microwave antenna devices described above.

The microwave apparatus may include a connecting device connecting the rod and the microwave antenna device, wherein the connecting device is configured to change the angle between the axis of the microwave antenna device and the axis of the rod.

The connecting device may comprise a swivel joint, hinge, flexible joint, ball joint or other similar joint.

Such a connector may allow the microwave antenna device to be adjusted or directed to align with the cervical inlet or cervical os. For example, such a coupling device may allow the selection of an angle between the axis of the microwave antenna device and the axis of the rod for axial alignment of the microwave antenna device with the cervical os. Changes in the orientation of the microwave antenna device can occur within the vaginal canal by adjusting the angle between the axis of the microwave antenna device and the axis of the rod after insertion of the microwave antenna device into the vagina. Alternatively, changes in the orientation of the microwave antenna device can take place outside the vaginal canal by pre-adjusting the angle between the axis of the microwave antenna device and the axis of the rod prior to insertion of the microwave antenna device into the vagina.

The location angle can be fixed from 1 to 90 degrees.

The microwave antenna device may be configured, eg, sized and/or shaped, to be inserted into and manipulated within the vagina. The microwave antenna device may be configured to be inserted into the vagina and manipulated within the vagina to reach one or more ectocervical and/or endocervical areas of the cervical surface tissue. The microwave antenna device may be configured to be inserted into the vagina and manipulated into the vagina by a colposcopist when the patient is in a supine lithotomy position.

The connector device may be configured to removably attach the microwave antenna device to the rod, which allows the installation of another microwave antenna device, which may have an alternative configuration, such as an alternative shape and/or size.

The microwave apparatus may include a handle or handle at or near its proximal end. For example, the microwave apparatus may include a handle or handle at or near the proximal end of the shaft.

The handle or handle may be attached to the rod with the possibility of removal. This may allow the handle or handle to be detached from the shaft. The microwave antenna device and shaft may be disposable, and detaching the handle or handle from the shaft may allow removal of the microwave antenna device and shaft. Alternatively, the microwave antenna device and shaft may be reusable, and detaching the handle or handle from the shaft may allow the microwave antenna device and shaft to be sterilized before reuse.

The handle or handle and the axis of the rod may be coaxial. The handle or handle may be positioned at an angle relative to the axis of the rod. For example, the handle or handle may be positioned at 30, 45, or 90 degrees with respect to the shaft axis.

The handle or handle may be disposable or reusable.

The microwave apparatus may include an electrical switch that can be toggled between an on state, in which the switch allows transmission of microwave energy from the microwave generator to the microwave antenna device, and an off state, in which the switch prevents transmission of microwave energy from the microwave generator to the microwave antenna device. The handle or handle may include a manual control element, such as a button or the like, for toggling the electrical switch between on and off states.

The microwave apparatus may include an electrical connector, such as a coaxial electrical connector, to provide an electrical connection between the microwave apparatus and the microwave generator via the microwave waveguide. The microwave apparatus may include an electrical connector, such as a coaxial electrical connector, for providing an electrical connection between the microwave apparatus and the microwave generator via a microwave cable, such as a flexible and/or coaxial microwave cable. An electrical connector, for example, may be electrically connected to an electrical switch.

This document describes a microwave system for radiating microwave energy into the surface tissues of the cervix, the system comprising:

microwave generator;

any of the microwave apparatus described above; And

microwave waveguide,

wherein the microwave waveguide electrically connects the microwave generator and the microwave apparatus.

The microwave waveguide may comprise a microwave cable, such as a flexible and/or coaxial microwave cable.

The microwave waveguide may be rigidly attached to the microwave apparatus, such as soldered, welded, or attached with electrically conductive adhesive.

The microwave waveguide may be placed in the rod. The rod may provide mechanical support for the microwave waveguide.

The microwave apparatus may include an electrical connector, such as a coaxial electrical connector, wherein the microwave waveguide is electrically connected to the electrical connector.

The microwave system may comprise information processing resources configured to control the microwave generator to select one or more characteristics of the microwave energy provided by the microwave generator.

The information processing resources may be configured to control the microwave generator to provide a desired target beam pattern for one or more target microwave energy characteristics when the microwave antenna device is located at a distance from another object such that the desired target beam pattern is not disturbed by the proximity of any or another object.

The information processing resources may be configured to control the microwave generator to provide the desired target radiation pattern for one or more specified microwave energy characteristics when the microwave antenna device is located away from the surface of the cervix so that the desired target radiation pattern is not disturbed by the proximity of the surface. cervix.

The information processing resources may be configured to control the microwave generator to provide the desired predetermined radiation pattern for one or more predetermined microwave energy characteristics when the microwave antenna device is used to apply microwave energy to the cervix.

The information processing resources may be configured to control the microwave generator to provide the desired therapeutic effect for one or more specified microwave energy characteristics when the microwave antenna device is applied to apply microwave energy to the cervix.

The information processing resources may be configured to control the microwave generator to generate the correct biological response for one or more specified microwave energy characteristics in one or more areas, such as one or more infected areas, of the cervix.

The information processing resources may be configured to control the microwave generator to induce local non-ablative hyperthermia of the cervical surface tissue for one or more specified microwave energy characteristics.

The information processing resources may be configured to control the microwave generator to generate a biological response in one or more HPV-infected and/or CIN-diagnosed surface tissue regions of the cervix for one or more specified microwave energy characteristics.

The information processing resources may be configured to control the microwave generator to cause local ablation of the surface tissue of the cervix for one or more predetermined microwave energy characteristics.

The information processing resources may be configured to control the microwave generator to cauterize the surface tissue of the cervix for one or more predetermined microwave energy characteristics.

One or more specified characteristics of microwave energy may include at least the following: frequency, frequency spectrum, power, power density, energy, energy density, intensity, intensity, amount, amplitude, exposure time, dose, pulse duration, and pulse repetition rate of microwave energy. .

The one or more specified microwave energy characteristics may comprise a frequency in the range of about 500 MHz to about 200 GHz, in the range of about 900 MHz to about 100 GHz, or in the range of about 5 GHz to about 15 GHz.

One or more specified characteristics of microwave energy may contain a frequency of about 8 GHz.

One or more specified microwave energy characteristics may comprise a power from 0.1 W to 20 W.

The one or more preset microwave energy characteristics may comprise an exposure time in the range of 0.1 s to 30 s.

This document describes a method for forming any of the microwave antenna devices described above.

The method may comprise forming one or more dielectric elements of the microwave antenna device by forming one or more dielectric materials on, over and/or around any or all electrically conductive elements of the microwave antenna device. Such a method can cause the electrically conductive elements of the microwave antenna device to become an integral part of the formed microwave antenna device, thereby preventing any assembly requirements for the microwave antenna device.

The method may comprise forming one or more dielectric elements using an injection molding process. The injection molding process may comprise injection molding one or more dielectric materials to form one or more dielectric elements. Thus, lower cost and more efficient production can be obtained, especially when producing a large number of microwave antenna devices and/or rods, such as a large number of disposable microwave antenna devices and/or rods.

The injection molding process may comprise forming one or more dielectric materials on, over and/or around the elongate member and/or the ground member.

The injection molding process may comprise forming one or more dielectric materials on, over, and/or around a dielectric material that at least partially covers the elongate member and/or the ground member.

The injection molding process may comprise forming one or more dielectric materials on, over and/or around an existing component already present in the mold cavity. This process is known as multilayer molding. Such an existing component may include any or all of the features of a microwave antenna device.

The one or more dielectric materials may include any one or more of the following: acrylonitrile butadiene styrene (ABS), nylon, polyethylene terephthalate (PET), polyimide, polypropylene, and polytetrafluoroethylene (PTFE).

The method may comprise forming one or more dielectric elements using cold compression, in which one or more dielectric materials in powder form are compressed into a desired shape either by a piston or by an extrusion process. Such a cold compression process may be suitable for PTFE.

The method may include forming one or more dielectric elements by mechanical processing, such as turning a solid workpiece of dielectric material. Such a method may be suitable for synthetic fluoropolymer materials such as polytetrafluoroethylene (PTFE), as such materials may not be suitable for conventional injection molding processes.

The method may comprise attaching the microwave antenna device to the rod with an adhesive. For example, the method may include attaching a microwave antenna device to a rod using cyanoacrylate and/or epoxy adhesive.

The method may comprise attaching the microwave antenna device to the rod using thermal fusion of the microwave antenna device and the rod to each other. Thermal fusion can be an effective bonding method if the microwave antenna device and/or rod contain a synthetic fluoropolymer material.

The method may comprise forming a grounding element by at least one of the following methods: coating, molding, pressing, 3D printing, attaching to a shaped dielectric, applying an electrically conductive material to a 3D surface, and the like.

The grounding element may be composed of or contain one or more metals.

The elongated element may contain one or more metals or be formed from them.

The method may comprise forming an electrical connection between an outer conductor of the microwave antenna device and a ground element of the microwave antenna device. The method may comprise soldering or welding the outer conductor and the grounding element to each other. The method may include using a conductive epoxy resin to form an electrical connection between the outer conductor and the ground element. The method may include mechanically connecting the outer conductor and the grounding element to form an electrical connection between the outer conductor and the grounding element, for example, by pressing.

This document describes a method for irradiating the surface tissue of the cervix with microwave energy, the method comprising the following:

bringing the surface of the cervix into contact with the distal surface of any of the microwave antenna devices described above; And

using a microwave antenna device to deliver microwave energy to the cervix.

The method may comprise selecting one or more microwave energy characteristics so as to provide the desired target radiation pattern when the microwave antenna device is located away from any other object such that the desired target radiation pattern is not disturbed by the proximity of any other object.

The method may comprise selecting one or more microwave energy characteristics to provide the desired target radiation pattern when the microwave antenna device is located away from the cervical surface such that the desired target radiation pattern is not disturbed by the proximity of the cervical surface.

The method may include selecting one or more characteristics of microwave energy from frequency, frequency spectrum, power, power density, energy, energy density, intensity, strength, amount, magnitude, exposure time, dose, pulse duration, pulse repetition rate, etc. to provide the desired specified radiation pattern.

The method may comprise selecting one or more microwave energy characteristics to provide a therapeutic effect when the microwave antenna device is used to apply microwave energy to the cervix.

The method may comprise selecting one or more microwave energy characteristics to generate the correct biological response in one or more areas, such as one or more infected areas of the cervix.

The method may comprise the following: match or make substantially the same relative permittivity of the microwave antenna device and the relative permittivity of cervical tissue for one or more given characteristics of microwave energy. This can improve the efficiency of microwave energy transfer to the cervical tissue. This can significantly reduce the risk of heating of the microwave antenna device itself and thus reduce the risk of accidental tissue burn if the antenna touches any adjacent tissue immediately after treatment.

The method may comprise the following: selecting a relative permittivity that differs by less than 50%, less than 10%, less than 1%, or less than 0.1% from the relative permittivity of the cervical tissues for one or more given characteristics microwave energy.

The method may comprise the following: selecting one or more characteristics of microwave energy from spatial distribution, frequency, frequency spectrum, power, power density, energy, energy density, intensity, strength, amount, magnitude, exposure time, dose, pulse duration, pulse repetition frequency and the like to provide the desired therapeutic effect.

The method may comprise selecting a microwave energy frequency in the range of about 500 MHz to about 200 GHz, in the range of about 900 MHz to about 100 GHz, or in the range of about 5 GHz to about 15 GHz.

The method may comprise: selecting a microwave energy frequency of about 8 GHz.

The method may include the following: choose the power of microwave energy from 0.1 W to 20 W.

The method may include the following: choose the exposure time from 0.1 to 30 seconds.

The method may comprise selecting one or more characteristics of the microwave energy so as to induce localized non-ablative hyperthermia of the superficial tissue of the cervix.

The method may comprise the following: selecting one or more characteristics of microwave energy from spatial distribution, frequency, frequency spectrum, power, power density, energy, energy density, intensity, strength, amount, magnitude, exposure time, dose, pulse duration, pulse repetition frequency and the like to induce localized non-ablative hyperthermia of the superficial tissue of the cervix.

The method may comprise the following: one or more characteristics are selected so as to create a biological response in one or more areas of the surface tissue of the cervix infected with HPV and/or diagnosed with CIN.

The method may comprise the following: selecting one or more characteristics of microwave energy from spatial distribution, frequency, frequency spectrum, power, power density, energy, energy density, intensity, strength, amount, magnitude, exposure time, dose, pulse duration, pulse repetition frequency and the like, to create a biological response in one or more areas of the superficial tissue of the cervix infected with HPV and/or diagnosed with CIN.

The method may comprise selecting one or more characteristics of the microwave energy so as to cause ablation of the superficial tissue of the cervix.

The method may comprise the following: selecting one or more characteristics of microwave energy from spatial distribution, frequency, frequency spectrum, power, power density, energy, energy density, intensity, strength, amount, magnitude, exposure time, dose, pulse duration, pulse repetition frequency and the like to cause ablation of the superficial tissue of the cervix.

The method may comprise selecting one or more characteristics of the microwave energy so as to cause cauterization of the surface tissue of the cervix. For example, after LEEP, cauterization of the superficial tissues of the cervix may be helpful.

The method may comprise the following: selecting one or more characteristics of microwave energy from spatial distribution, frequency, frequency spectrum, power, power density, energy, energy density, intensity, strength, amount, magnitude, exposure time, dose, pulse duration, pulse repetition frequency and the like to cause cauterization of the superficial tissue of the cervix.

Brief description of the drawings

Now, by way of a non-limiting example only, a microwave antenna device or applicator, a microwave apparatus, and a microwave system will be described with reference to the following figures, in which:

in fig. 1 is a schematic representation of the human cervix;

in fig. 2 is a schematic illustration of the type I transformation zone of the human cervix;

in fig. 3 is a schematic illustration of the type II transformation zone of the human cervix;

in fig. 4 is a schematic illustration of the type III transformation zone of the human cervix;

in fig. 5 is a schematic illustration of a microwave system;

in fig. 6 is an illustration of external features of a "type A" microwave antenna device for use in processing a type I (T1) CIN transformation zone;

in fig. 7 is an illustration of external features of a "type B" microwave antenna device for use in processing a type II (T2) CIN transformation zone;

in fig. 8 is an illustration of external features of a "Type C" microwave antenna device for use in processing a Type III (T3) CIN transformation zone;

in fig. 9 is an illustration of the external features of a "type D" microwave antenna device, which may be a variant of the "type C" antenna intended for use when dysplasia occurs only at the opening of the pharynx and extends into the pharynx through the cervix;

in fig. 10 is an illustration of external features of a type A, B, and C microwave antenna device;

in fig. 11 is a sectional view of a type A, B, C and D microwave antenna device used on the cervix;

in fig. 12 is a cross-sectional view of the internal features of the type A, B, C, and D microwave antenna assembly;

in fig. 13 is a representation of the distribution of electromagnetic fields and in particular microwave fields in the cervix as SAR (Surface Absorption Rate) using a microwave antenna device common to Types A, B and C;

in fig. 14 shows the scatter parameter S11, a mathematical construct that determines how RF energy propagates through the microwave antenna device into tissue;

in fig. 15 is a representation of the distribution of electromagnetic fields and in particular microwave fields in the cervix as SAR (Surface Absorption Rate) using a microwave antenna device common to Types A, B and C where the metal ground layer is in contact with tissue;

in fig. 16 is a representation of the distribution of electromagnetic fields, and in particular microwave fields, in the cervix as SAR (Surface Absorption Rate) using a microwave antenna device common to Types A, B, and C, with the metallic ground layer not in contact with tissue;

in fig. 17 shows the effect of the critical overall length of the center conductor of a microwave antenna device in achieving the overall distribution of microwave field energy in tissue more restricted to the ground plane;

in fig. 18 shows the effect of the critical overall length of the center conductor of a microwave antenna device in achieving the overall pattern of microwave field energy distribution in tissue more delimited from the ground plane;

in fig. 19 shows the effect of the critical radial distance from the ground plane to the outer shape of the microwave antenna device on the overall distribution of microwave field energy in tissue;

in fig. 20 shows the influence of equal diameters of the ground layer and the external shape of the microwave antenna device on the overall picture of the energy distribution of microwave fields in the tissue;

in fig. 21 shows the effect of the critical radial distance from the ground plane to the outer shape of the microwave antenna device on the overall pattern of energy distribution of microwave fields in tissue when the length of the center conductor is increased;

in fig. 22 shows the effect of equal diameters of the ground layer and the outer shape of the microwave antenna device on the overall pattern of energy distribution of microwave fields in tissue when the length of the center conductor is increased;

in fig. 23 shows the effect of the conical ground layer of a microwave antenna device on the overall pattern of the energy distribution of electromagnetic fields in tissue;

in fig. 24 shows the effect of an inverted cup-shaped ground layer of a microwave antenna device on the overall picture of the energy distribution of electromagnetic fields in tissue;

in fig. 25 shows the effect of a ground layer in the form of a cup of a microwave antenna device on the overall pattern of the energy distribution of electromagnetic fields in tissue;

in fig. 26 shows a general picture of the energy distribution of microwave fields in tissue when the ground layer of the microwave antenna device is not in contact with the tissue;

in fig. 27 shows the effect of a longer center conductor length of a microwave antenna device, showing a non-uniform overall pattern of microwave field energy distribution in tissue with higher fields towards the endocervix and reduced fields towards the ectocervix;

in fig. 28 shows compensation for the effect of the increased length of the center conductor of a microwave antenna device by reshaping the center conductor to achieve a uniform overall pattern of microwave field energy distribution throughout the cervical region; And

in fig. 29 shows the microwave apparatus of the microwave system shown in FIG. 5.

Detailed description of the invention

A typical schematic illustration of a healthy human cervix is shown in FIG. 1. The cervix 1 of the uterus consists of an external part in the form of an ectocervix 2 and an endocervix 3, a canal connecting the cavity 4 of the uterus and the cavity 5 of the vagina. The exit of the cervix 1 of the uterus into the vaginal cavity 5 is known as the external os 6. The area where the endocervix 3 meets the ectocervix 2 is called the transformation zone 7 (TZ). This area is most vulnerable to CIN (cervical neoplasia) and is believed to be where most abnormalities occur. In FIG. 2 is a schematic representation of a Type I Transformation Zone (TZ) 8 which is fully ectocervical, fully visible and may be small or large. Type II TZ 9 having an endocervical component but still fully visible with little or more ectocervical component is shown in FIG. 3. TZ 10 type III shown in FIG. 4 has an endocervical component and the upper border is not fully visible; the ectocervical component, if present, may be small or large.

In FIG. 5 shows a microwave system, indicated generally at 100, for treating cervical tissue. The microwave system 100 includes a microwave generator 11 for providing microwave energy, a flexible microwave connection cable such as a coaxial cable 12, a handle or handle 13, and a microwave antenna device 14.

As shown in more detail in FIG. 29, the handle or handle 13 and the microwave antenna device 14 are connected by a shaft 202. The handle or handle 13, the microwave antenna device 14 and the shaft 202 together constitute the microwave apparatus 200. The microwave apparatus 200 is connected to the microwave generator 11 by a coaxial cable 12. The coaxial cable 12 passes through a rod 202 between the handle or handle 13 and the microwave antenna device 14. The microwave apparatus 200 also includes a connector 204 for connecting the microwave antenna device 14 and the rod 202. The connector device is configured to change the angle between the axis of the microwave antenna device 14 and the axis of the rod 202 For example, the coupling device 204 may include a swivel, hinge, flexible joint, ball joint, and the like. Such a connector device 204 may allow the microwave antenna device 14 to be adjusted or directed to align with the cervical inlet or cervical os. For example, such a coupling device 204 may allow the angle between the axis of the microwave antenna device 14 and the axis of the shaft 202 to be chosen to axially align the microwave antenna device 14 with the cervical os. Changes in the orientation of the microwave antenna device 14 can occur within the vaginal canal by adjusting the angle between the axis of the microwave antenna device 14 and the axis of the rod 202 after the microwave antenna device 14 is inserted into the vagina. Alternatively, changes in the orientation of the microwave antenna device 14 can take place outside the vaginal canal by pre-adjusting the angle between the axis of the microwave antenna device 14 and the axis of the rod 202 prior to insertion of the microwave antenna device 14 into the vagina. For example, the location angle may be a fixed angle from 1 to 90 degrees.

The microwave antenna device 14 may be configured, for example, sized and/or shaped, to be inserted into and manipulated within the vagina. The microwave antenna device 14 may be inserted into the vagina and manipulated within the vagina to reach one or more ectocervical and/or endocervical areas of the cervical surface tissue. The microwave antenna device 14 may be configured to be inserted into the vagina and manipulated into the vagina by a colposcopist when the patient is in a supine lithotomy position.

The connector device 204 may be configured to removably attach the microwave antenna device 14 to the rod 202, which allows the installation of another microwave antenna device, which may have an alternative configuration, such as an alternative shape and/or size. The connector device 204 may include an electrical connector (not shown), such as a coaxial electrical connector, to provide electrical connection/disconnection of the microwave antenna device 14 and the coaxial cable 12.

The handle or handle 13 can be attached to the rod 202 with the possibility of removal. This may allow the handle or handle 13 to be disconnected from the shaft 202. The handle or handle 13 may include an electrical connector (not shown), such as a coaxial electrical connector, to provide electrical connection/disconnection of the handle or handle 13 and the coaxial cable 12.

Microwave antenna device 14 and shaft 202 may be disposable and detachment of handle or handle 13 from shaft 202 may allow removal of microwave antenna device 14 and shaft 202. Alternatively, microwave antenna device 14 and shaft 202 may be reusable and detachment of handle or handle 13 from stem 202 may allow microwave antenna device 14 and stem 202 to be sterilized before reuse.

Handle or handle 13 is angled with respect to the axis of shaft 202. For example, handle or handle 13 may be angled at 30, 45, or 90 degrees with respect to the axis of shaft 202, similar to a pistol grip.

The microwave apparatus 200 also includes an electrical switch 206 that can be toggled between an on state, in which the switch 206 allows transmission of microwave energy from the microwave generator 11 to the microwave antenna device 14, and an off state, in which the switch 206 prevents transmission of microwave energy from the microwave generator 11 to the microwave antenna device 14. The handle or knob 13 includes a manual control, such as a push button 208 or the like, to toggle the electrical switch 206 between on and off states.

The outer shape of the microwave antenna device 14 can take on various shapes depending on the required types of TZ and the treatment area for the CIN. For the treatment of TZ I shown in FIG. 2, in which only the lower outer surface of the ectocervical region is affected by the neoplasm 7, the Type A microwave antenna device shown in FIG. 6. From the type A microwave antenna device shown in FIG. 6 do not require treatment of the cervical os 6. Therefore, the central member of the distal end 15 does not have to be of considerable length and does not need to propagate microwave energy. The purpose of the central element 15 is to provide a centering aid to the user by ensuring that the periphery or diameter of the central element 15 is in central/coaxial contact with the ectocervix.

In the treatment of TZ II CIN shown in FIG. 3, there is a combination of visible ectocervical and endocervical areas with neoplasia 8, thus the type B microwave antenna device shown in FIG. 7 has a radiating core 16 which serves not only to position the microwave antenna device relative to the cervix, but also to supply energy to the proximal cervical os 6, for example for the first 3 mm.

In the treatment of TZ III CIN shown in FIG. 4, there is neoplasia 9 in the visible ectocervical region along with visible or invisible endocervical regions. Therefore, the type C microwave antenna device shown in FIG. 8 has a radiating core 17 which serves not only to position the microwave antenna device relative to the cervix, but also to deliver energy to the endocervical region, which is farther than that which can be treated with a type B microwave antenna device.

In such situations, since the patient has no or very little ectocervical CIN and the dysplasia only occurs at the orifice 6 and continues into the pharynx 6, the Type D microwave antenna device shown in FIG. 9. The type D microwave antenna device shown in FIG. 9 may be, for example, a variation of the type C microwave antenna device. Here, the type D microwave antenna device comprises a central element 18 that is configured to radiate microwave energy predominantly in the radial direction.

External elements of the microwave antenna device 14 of any type are formed to accommodate a range of anatomical types, which may vary from patient to patient. Common to types A, B and C is the shape shown in FIG. 10, which may be tapered or parallel along the main axis, with a rounded distal end 19 to center the antenna with respect to the axis of the cervical os 6. Common to types A, B and C is a circular cup-shaped element 20 which prevents over-insertion into the os 6 of the cervix and conforms to the shape of a typical proximal ectocervix 2. Overall diameter of the antenna 21 which should not interfere with the operation of the speculum and/or the view of the cervix through the colposcope , designed to match the typical diameter of the same area. The tilt angle of the microwave antenna device 14 to the cervix is determined by a combination of the axis angle of the rod 202 of the microwave apparatus 200 relative to the patient being monitored by the operator and the axis angle of the microwave antenna device 14 given by the rod 22 on which the microwave antenna device 14 is mounted. so that the axis of the microwave antenna device and the axis of the throat opening are parallel. This may serve to ensure that the forward-facing distal surface of the microwave antenna device 14 fits evenly into the cervix, resulting in uniform exposure to microwave energy and hence uniform processing. As will be described in more detail below, the non-conductive coating 23 covers any exposed metal components that form the microwave apparatus 200. This can reduce the risk of high intensity electromagnetic fields that can result in unintentional burn/energy absorption when microwave energy is emitted from the microwave antenna device. 14. This cover 23 is made from a biocompatible, substantially electromagnetically transparent material such as polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), or fluoroethylene polymer (FEP), or other copolymer coating. The length and diameter of the shaft 202 is designed to allow the user to move easily when opening the vagina with a speculum without blocking the user's view through the colposcope.

A cross section of the microwave antenna assembly 14, common to types A, B and C, is shown in FIG. 11. The antenna is applied to cervical tissue 25 through air 26.

In FIG. 12 is a cross-sectional view of an exemplary Type A, B, and C microwave antenna assembly 14. The Type D microwave antenna assembly has the same features as shown in FIG. 12 except for the cup-shaped element. The microwave antenna device 14 includes an electrically conductive elongate member in the form of a center conductor 30 and an electrically conductive ground member in the form of an antenna ground layer 31 . The antenna ground layer 31 defines an opening 31a through which the center conductor 30 passes. The microwave antenna device 14 also includes a dielectric element 33 which covers at least a portion of the distal or forward-facing surface of the antenna ground layer 31 and which defines the outer distal or forward-facing surface or the shape of the microwave antenna device 14. The dielectric element 33 also insulates the center conductor 30 from the antenna ground layer 31, where the center conductor 30 passes through a hole in the antenna ground layer 31.

The coaxial cable 27 is formed by an outer conductor in the form of an electrically conductive outer shield 28, an additional dielectric element 29 and a center conductor 30. The outer shield 28 is securely and integrally connected to the ground layer 31 of the antenna to ensure that all energy is transferred to the required area. Failure to achieve this can result in lower energy distribution efficiency and non-uniform fields, which can result in uneven treatment zones. One of ordinary skill in the art will appreciate that coaxial cable 12 may pass through stem 202 of microwave apparatus 200, and center conductor 30 and outer shield 28 of microwave antenna device 14 may be electrically connected to a respective center conductor (not shown) and a respective shield (not shown). ) of the coaxial cable 12. The microwave antenna device 14 also includes an insulating protective sheath 32 on the outer surface of the outer shield 28.

Another dielectric element, in the form of a dielectric protective element 34, provides additional protection and serves to avoid contact between the ground layer 31 and the cervical tissue. Another dielectric element in the form of an outer shell 35 provides additional protection and insulation for the ground layer 31.

Any one or more of the dielectric elements 32, 33, 34 and 35 may comprise or be formed from any low loss biocompatible material. For example, any one or more dielectric elements 32, 33, 34, and 35 may comprise or be formed from at least one of the following: acrylonitrile butadiene styrene (ABS), nylon, polyethylene terephthalate (PET), polyimide, polycarbonate, PC-ABS, polypropylene, ceramics such as alumina and FEP.

Any one or more of the dielectric elements 32, 33, 34 and 35 may comprise or be formed from the same material.

The center conductor 30 and the ground layer 31 may consist of or be formed from a metal such as copper, stainless steel, nickel, or the like.

Various microwave antenna devices were modeled using a 3D simulation model. In this case, the simulation model is HFSS (Ansoft Corporation), which is a full wave electromagnetic finite element method (FEM) solver. The simulation may allow calculation of the predicted response for communication efficiency and specific absorption rate (SAR). SAR is a measure of the absorption of energy by the human body in one second when exposed to a radio frequency (RF) radio frequency electromagnetic field.

In FIG. 13 is a representation of the distribution of microwave fields obtained using the microwave antenna device 36 in tissue 37 such as cervical tissue. The microwave antenna device 36 enters the endocervical canal 38 of the cervix. That part of the microwave antenna device 36 that is not in contact with the tissue 37 was formed in the air 39. The SAR field distribution 40 for the microwave fields is shown using the grayscale map 41. The response of the scatter parameter S11, which determines how the RF energy propagates through the microwave antenna device into the tissue, is shown in FIG. 14. Operating frequency for microwave fields is plotted on the x-axis, while S11 or return loss is shown on the y-axis in decibels. The graph shows that over 99% of the energy is delivered to the tissue at 8 GHz, indicating a very good match between antenna 36 and tissue 37 at 8 GHz.

The operating frequency of the microwave energy plays a fundamental role in determining the depth of tissue penetration and the overall dimensions of the treatment area. 8 GHz is a frequency that can provide a good balance of energy penetration density for a given power. Frequencies below 8 GHz may penetrate too deeply. Frequencies above 8 GHz may not penetrate deep enough for a correct biological response.

Fig. 15 illustrates the case where the fabric is in contact 42 with a metal ground layer, showing SAR fields 43. A high concentration of electric fields at the metal-fabric interface can cause subsequent charring and tissue burns. Then, in FIG. 16 shows 44 SAR fields for a microwave antenna device that includes a dielectric element 45 that covers a portion of the metal ground layer to avoid metal-to-cloth contact between the fabric and the metal ground layer and provide a safer solution with 44 SAR fields less coaxially distributed. compared to FIG. 15.

With reference to FIG. 17, the overall length 46 of the center conductor 47 axially projecting from the ground layer 48 is critical to achieving an overall scheme for transferring all of the energy to the tissue. For example, in a Type D microwave antenna arrangement, center conductor 47 extends from ground plane 48 to a predetermined length 46. FIG. 17 shows the distribution pattern 49 of the SAR field when the center conductor 47 projects axially from the ground layer 48 by 10 mm. The distribution pattern 49 of the SAR field shows that the fields towards the ground plane are stronger. This may be useful for treating volume in the ectocervical region. In FIG. 18, if the length of the center conductor 50 is 15 mm, the fields 51 may be drawn more towards the proximal region or away from the ground plane. This can be used in the treatment of TZ CIN type II or III with an endocervical component.

In FIG. 19 shows how the radial offset distance 52 between the radial extent of the ground layer 53 and the radial extent or radially outward profile of the outer mold 54 is critical to achieving an overall stronger distally extended tissue energy distribution pattern 55 . The center conductor 56 may have a specific length, such as 10 mm. In FIG. 20, the outer mold 57 and the ground layer 58 are identical in diameter, indicating the movement of the fields away from the ground layer 59 compared to the fields 55 shown in FIG. 19. The microwave antenna device shown in FIG. 20 can be used in the treatment of various types of TZ CIN with or without an endocervical and ectocervical component.

In FIG. 21 shows how the effects of changing the radial offset distance 60 between the radial extent of the ground layer 61 and the radial extent of the outer shape 62 of the microwave antenna device can be compensated for by increasing the length of the center conductor 56. In particular, in FIG. 21 shows the SAR field for radial displacement 60 between ground layer 61 and outer mold 62, identical to radial displacement 52, but when center conductor 63 projects further above the ground layer than center conductor 56 shown in FIG. 19. Fields 64 are kept away from ground plane 61.

In FIG. 22 showing a variant of FIG. 21 without a radial gap between the ground layer 65 and the outer mold 66. Fields 64 and 67 are almost identical in terms of distribution area, despite the different radial distances. This may also mean that the influence of the elongated center conductor on the field distribution pattern dominates the influence of the difference in radial distances between the outer shape and the ground plane.

The ground layer can be shaped to distribute different forms of electromagnetic fields into the tissue, which in turn can be used to treat different types of TZ neoplasia. For example, in FIG. 23 shows a cone shaped ground layer 68 that can transfer more energy 69 to the endocervical component 3 of the neck 1, while the inverted cup shaped ground layer 70 shown in FIG. 24 can radiate more near the ground layer, ie radiate the 71 SAR field more into the ectocervical component of the cervix.

In FIG. 25 shows another form of ground layer 72 with a bowl structure that can spread and draw radiation 73 further into the ectocervical component of the cervix.

If the ground layer of the microwave antenna device shown in FIG. 20 comes into contact with tissue, it may result in strong electromagnetic fields, which may cause charring of the tissue. Alternatively, as shown in FIG. 26, the antenna is moved away from the tissue, avoiding the possibility of ground layer 74 contacting tissue 75, and there is no change in radiation field 76 compared to field 59.

In FIG. 27 shows how the shape of the center conductor, in particular the extended center conductor, can affect the field distribution. In FIG. 27 depicts a 20 mm long central conductor 77 showing an uneven pattern of field 78 while being able to radiate more into the endocervical component of the cervix. Similarly, with reference to FIG. 28, by thickening the central conductor 79 at the bottom and narrowing it towards the top, fields 80 can be aligned and evenly transmitted along the entire length of the cervix in advanced cases of CIN.

Those skilled in the art will appreciate that various modifications may be made to any device, apparatus or system described above. For example, to limit the spread of energy in the axial direction, a cap-shaped electrically conductive element may be provided at or near the distal end of the microwave antenna device. For example, the distal end of the outer surface of the microwave antenna device may be defined by one or more dielectric elements, and the cap may be positioned between the distal end of the elongated conductor and the distal end of the outer surface of the microwave antenna device. Alternatively, the cap may define the distal end of the outer surface of the microwave antenna device.

The conductive shield of a coaxial cable may consist of two components. For example, the conductive shield of a coaxial cable may comprise a mesh or braid of conductive material and a foil wrap. Foil wrap can complement mesh or weave.

The coaxial cable may be coated. The cover may contain any suitable insulating material such as PTFR, PEEK, FEB or parylene. Such a coating can increase strength. Such a coating can reduce friction to improve the ease of sliding the cable relative to another object.

Claims (66)

1. Microwave antenna device for microwave irradiation of the surface tissue of the cervix, containing: an electrically conductive grounding element forming a hole; electrically conductive elongated element passing through the specified hole and ending at the distal end; And one or more dielectric elements, wherein one or more dielectric elements electrically isolate the elongated element and the grounding element from each other, wherein said one or more dielectric elements determine the central distal element for centering the microwave antenna device relative to the axis of the pharynx of the cervix and define cup-shaped element to overlap the proximal portion of the ectocervix of the cervix and prevent excessive insertion of the Central distal element in the pharynx of the cervix. 2. The microwave antenna device of claim 1, wherein the ground element and the elongated element are coaxial. 3. A microwave antenna device according to claim 1 or 2, wherein one or more dielectric elements form an outer surface to interact with the surface of the cervix. 4. A microwave antenna device according to any one of the preceding claims, wherein one or more dielectric elements cover said distal end of the elongate element and/or one or more dielectric elements cover the distal portion of the elongate element. 5. A microwave antenna device according to any one of the preceding claims, wherein the elongated element extends axially beyond the ground element. 6. The microwave antenna device of claim 5, wherein one or more dielectric elements cover a portion of the elongate element that extends axially beyond the grounding element, or one or more dielectric elements cover the elongate element over its entire portion that protrudes axially. direction outside the grounding element. 7. The microwave antenna device according to any one of the preceding claims, wherein the one or more dielectric elements are configured to prevent the elongate element from contacting the surface of the cervix when the microwave antenna device is used. 8. A microwave antenna device according to any one of the preceding claims, wherein one or more dielectric elements are configured to separate the ground element and/or elongate element from cervical surface tissue. 9. A microwave antenna device according to any one of the preceding claims, wherein one or more dielectric elements fill a hole formed by the ground element. 10. A microwave antenna device according to any one of the preceding claims, wherein the central distal member is configured to transmit microwaves to the proximal cervical os. 11. A microwave antenna device according to any one of the preceding claims, wherein one or more dielectric elements cover at least a portion of the ground element. 12. A microwave antenna device according to any one of the preceding claims, wherein one or more dielectric elements cover at least a portion of the distal surface of the ground element. 13. A microwave antenna device according to any one of the preceding claims, wherein the microwave antenna device defines an axis and the microwave antenna device is cylindrically symmetrical about that axis. 14. A microwave antenna device according to claim 13, wherein the elongated element is in the form of a rod, cylindrical and/or conical. 15. A microwave antenna device according to claim 13 or 14, wherein the radial extent of the grounding element is greater than or less than the radial extent of said one or more dielectric elements. 16. Microwave antenna device according to any one of paragraphs. 13-15, in which the grounding element corresponds to at least one of the following characteristics: the grounding element is annular or generally annular; the grounding element is flat or generally flat; the grounding element is curved; the grounding element is cup-shaped so that the opening is oriented towards the distal end of the elongated element; And the grounding element is in the form of an inverted cup, so that the hole is oriented from the distal end of the elongated element. 17. A microwave antenna device according to any one of the preceding claims, comprising an electrically conductive cap at the distal end of the electrically conductive elongate member. 18. The microwave antenna device according to claim 17, wherein the distal end of the outer surface of the microwave antenna device is formed by one or more dielectric elements, and the electrically conductive cap is located between the distal end of the electrically conductive elongated element and the distal end of the outer surface of the microwave antenna device. 19. A microwave antenna device according to any one of the preceding claims, wherein the microwave antenna device is disposable or reusable. 20. A microwave antenna device according to any one of the preceding claims, wherein the microwave antenna device is adapted to be used to irradiate the surface tissue of the cervix with microwaves for: providing a therapeutic effect in one or more areas, such as one or more areas of the cervix infected with human papillomavirus (HPV) and/or diagnosed with cervical intraepithelial neoplasia (CIN); and/or creating a correct biological response in one or more areas, such as one or more areas of the cervix infected with human papillomavirus (HPV) and/or diagnosed with cervical intraepithelial neoplasia (CIN); and/or localized non-ablative hyperthermia of the surface tissue of the cervix; and/or localized ablation of the surface tissue of the cervix; and/or cauterization of the superficial tissue of the cervix. 21. An array of microwave antenna devices for irradiating the surface tissue of the cervix with microwaves, wherein each microwave antenna device is the microwave antenna device of any one of the preceding claims, each microwave antenna device having a different configuration that provides a different radiation pattern. 22. Microwave apparatus for irradiating microwaves of the surface tissue of the cervix, containing a microwave antenna device according to any one of paragraphs. 1-20 and a rod connected to a microwave antenna device. 23. A microwave apparatus according to claim 22, comprising a connecting device connecting the rod and the microwave antenna device, wherein the connecting device is configured to change the angle between the axis of the microwave antenna device and the axis of the rod. 24. A microwave apparatus according to claim 23, wherein the connecting device comprises at least one of the following joints: a swivel, a swivel, a flexible joint, and a ball joint. 25. A microwave apparatus according to claim 23 or 24, wherein the connector is configured to removably attach a microwave antenna device to the rod, which allows another microwave antenna device to be attached to the rod, wherein the other microwave antenna device has a modified configuration with respect to said microwave antenna device. 26. Microwave apparatus according to any one of paragraphs. 22-25, in which the rod is disposable or the rod is reusable. 27. Microwave apparatus according to any one of paragraphs. 22-26 containing a handle at or near the proximal end. 28. The microwave apparatus of claim 27, wherein the handle is detachably attached to the shaft. 29. A microwave apparatus according to claim 27 or 28, wherein the handle is disposable or reusable. 30. Microwave apparatus according to any one of paragraphs. 22-29, comprising an electrical switch configured to switch between an on state, in which the switch allows transmission of microwave energy from the microwave generator to the microwave antenna device, and an off state, in which the switch prevents transmission of microwave energy from the microwave generator to the microwave antenna device. 31. Microwave apparatus according to any one of paragraphs. 27-29, comprising an electrical switch configured to switch between an on state, in which the switch allows transmission of microwave energy from the microwave generator to the microwave antenna device, and an off state, in which the switch prevents transmission of microwave energy from the microwave generator to the microwave antenna device, wherein the handle includes a manual control element, such as a button, for toggling the electrical switch between on and off states. 32. Microwave system designed for microwave irradiation of the surface tissue of the cervix, containing: microwave apparatus according to any one of paragraphs. 22-31; microwave generator; And microwave waveguide, wherein the microwave waveguide electrically connects the microwave generator and the microwave apparatus. 33. The microwave system of claim 32, wherein the microwave waveguide comprises a microwave transmission cable. 34. The microwave system of claim 33, wherein the microwave waveguide is housed in the rod. 35. A method of microwave irradiation of the surface tissue of the cervix, characterized in that the distal surface of the microwave antenna device according to any one of paragraphs. 1-20 put into contact with the surface of the cervix and using a microwave antenna device to emit microwaves and deliver microwaves to the cervix. 36. The method of claim 35, wherein the relative permittivity of the microwave antenna device is matched to the relative permittivity of the cervical tissue. 37. The microwave apparatus of claim 25, wherein said other microwave antenna device has a modified shape and/or size with respect to said microwave antenna device. 38. The microwave apparatus of claim 27, wherein the handle is located at or near the proximal end of the shaft. 39. The microwave system of claim 33, wherein the microwave transmission cable is a flexible and/or coaxial microwave transmission cable. 40. The method of claim 36 wherein the relative permittivity of the microwave antenna device is selected such that it differs from the relative permittivity of the cervical tissues by less than 50%, less than 10%, less than 1%, or less than 0.1% of the relative dielectric constant of the tissues of the cervix. 41. The method of claim 35, wherein the frequency of the microwaves emitted by the microwave antenna device is 500 MHz - 200 GHz, or 900 MHz - 100 GHz, or 5 - 15 GHz, or 8 GHz. 42. The method according to claim 35, in which the power of the microwave radiation of the microwave antenna device is 0.1 - 20 watts. 43. The method according to claim 35, in which the exposure time during which the microwave antenna device emits microwaves and delivers microwaves to the cervix is 0.1 - 30 s.

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