Cervical microwave applicator

Abstract

A microwave antenna device includes a conductive ground element defining a hole, a conductive elongated element extending through the hole and terminating at a distal end, and one or more dielectric elements. One or more of the dielectric elements electrically insulate the elongated element and the ground element from each other. The microwave antenna device can be configured to radiate microwave energy into surface tissue of the cervix to provide a therapeutic effect in one or more areas of the cervix (e.g., one or more areas of the cervix infected with human papillomavirus (HPV) and / or diagnosed with cervical intraepithelial neoplasia (CIN)), or to produce a correct biological response in one or more such areas. The microwave antenna device can be configured for local non-ablative thermal therapy of surface tissue of the cervix, local ablation of surface tissue of the cervix, and / or cauterization of surface tissue of the cervix.

Description

Technical Field

[0001] The present disclosure relates to a microwave antenna device or applicator, a microwave assembly and a microwave system for radiating microwave energy into the surface tissue of the cervix, particularly but not exclusively, for treating epithelial diseased tissue or conditions affecting tissue, such as cervical tumors. The present disclosure also relates to a method of manufacturing a microwave antenna device or applicator and a method of radiating microwave energy into the surface tissue of the cervix using the microwave antenna device or applicator. Background Art

[0002] It is known to use a microwave applicator to radiate microwave energy into the surface tissue of the cervix in order to promote heating and activate biological effects in the surface tissue of the cervix. The exact nature of these biological effects has not been quantified, but it may not be just the heat that causes certain biological responses, their magnitude, or the time required to manifest biological responses. Thermal effects can be seen when the tissue is in the range of 40°C to 50°C. Without wishing to be bound by theory, it is hypothesized that non-ablative microwave energy can upregulate certain interferon-regulated enzymes, such as 2'-5'-oligoadenylate synthetase. This is an antiviral enzyme that fights viral attack by degrading viral and host RNA. The enzyme uses (Adenosine triphosphate) ATP to synthesize 2'-5'-oligoadenylate in a 2'-specific nucleotide transfer reaction, upregulating potential ribonucleases (RNASELs), promoting degradation of viral RNA and inhibiting viral replication. Upregulation of RNASELs can be used to therapeutically target selective toxicity against immortalized E6 / E7 keratinocytes present in cervical tissue as a means of non-ablative treatment.

[0003] Another limitation of microwave antenna implementation is that any air gap between the dielectric and the target tissue will affect the microwave operating performance unless it has been adequately accommodated in the design and controlled by tuning in manufacturing. The air gap also allows the formation of higher order modes and can create a source of breakdown in high power applications, causing arcing and burning of the electrode. The effect of the air gap is particularly relevant if the relative dielectric constant or ε relative (Er) value of the dielectric is much larger than that of the surrounding air (Er1), such as in high dielectric tissues of Er20 Er40 Er70, etc.

[0004] The dielectric properties of the target tissue are one factor in determining the energy required to achieve a biological response and the temperature range (40°C to 50°C). The electrical conductivity of the tissue is another factor. Therefore, the energy range required is different and can be controlled by varying the combination of power (0.1W to 20W) and time (0.1s to 30s).

[0005] Cervical intraepithelial neoplasia (CIN) is a common precancerous lesion of the cervix associated with the human papillomavirus (HPV). It can occur in anyone, but is more common in young women who wish to preserve their fertility. Treatment usually involves surgical excision. The lesions may be present in any of three stages: CIN1, CIN2 or CIN3, depending on the degree of atypical hyperplasia: the lowest CIN1 (mild) to CIN2 (moderate), the highest CIN3 (severe). CIN2+ is collectively referred to as CIN2 (moderate) and CIN3.

[0006] According to the World Health Organization (WHO) Guidelines for the prevention, screening and treatment of cervical precancer: Supplementary material: GRADE evidence recommendation table and evidence profile for each recommendation, in 2013, the WHO standard practice is to screen women using cytology (Pap test), and when the cytology result is positive, the diagnosis of CIN is based on subsequent colposcopy, biopsy of suspicious lesions, and then treatment only if histology has confirmed CIN2+. CIN2+ can progress to invasive cancer of the cervix within 10 to 20 years.

[0007] The cervix represents the lower cylindrical distal portion of the uterus and is divided into two regions: the ectocervix and the endocervix. The ectocervix can be seen during speculum examination. The endocervix (or endocervical canal) is the internal cavity within the cervix that forms a passage between the vaginal cavity and the internal os of the cervix. The upper limit of the endocervical canal is called the internal os or isthmus and marks the transition from the endocervix to the endometrium.

[0008] Although the initial infection may occur anywhere in the cervical region, the subsequent atypical hyperplasia occurs in the area where two different cell types, columnar cells and squamous epithelial cells, meet. This junction moves from prepubertal to postpubertal years, leaving behind a "transformation zone."

[0009] In the transformation zone of type 1 (T1) CIN, only the inferior outer surface of the ectocervix is ​​disturbed by tumor; it is completely visible on inspection and no manipulation is required. In the transformation zone of type 2 (T2) CIN, both the ectocervix and endocervix are combined with tumor and are also visible without manipulation. In the transformation zone of type 3 (T3) CIN, the endocervix is ​​further extended beyond the visible range and manipulation may make the 3 mm opening visible.

[0010] CIN can be treated surgically by removing or destroying the cells covering the cervix (e.g. with ablative therapies such as laser treatment, heating or freezing, thermotherapy and cryotherapy). While this is effective in most cases, surgery can cause immediate side effects such as bleeding and infection, or later complications including difficulty with menstruation due to cervical scarring and early (preterm) delivery.

[0011] The loop electrosurgical excision procedure (LEEP) is a common invasive surgical procedure for the treatment and management of high-grade precancerous lesions of the cervix (CIN2+). LEEP is performed with the woman lying supine with her legs in stirrups and her buttocks on the lower edge of a table (dorsal lithotomy position). A speculum is placed in the vagina and the cervix is ​​the focus of a binocular or monocular microscope (colposcope). LEEP is also known as large loop excision of the cervical transition zone (LLETZ) in different geographic regions.

[0012] The LEEP intervention carries a significant risk of sequelae. Among patients undergoing LEEP, 67% reported pain, 86% experienced bleeding (2 to 8 weeks after the intervention), and 65% were discharged from the hospital—see the TOMBOLA (Trial Of Management of Borderline and Other Low-grade Abnormal smears) group, “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 LEEP-treated area may affect the incidence of delayed bleeding and exacerbate the pain experienced by patients. The most common method of cauterization is monopolar diathermy, where a pad is placed under the patient's buttocks to form a fixed electrode. A second electrode is placed at the desired cautery site, where the energy is concentrated by the small surface area of ​​the surgical instrument. The circuit is completed by passing an electrical current through the patient's body. As part of LEEP treatment, this secondary treatment can cause shock and burns to the patient, causing further discomfort - see Cheney FW, Posner KL, Kaplan RA, and Heald WM, "Burns from warming devices inanesthesia: A closed claims analysis," Anesthesiology, 80(4), 806-810, 1994.

[0013] About 10% of those treated went to see their GP, either for reassurance or for antibiotics for a suspected infection. Subsequent changes also included 70% experiencing disruption to their periods. Patients' lifestyle changes for up to six weeks also included not having sex or using tampons.

[0014] The effectiveness of LEEP as a treatment for CIN has been reported to be 86% to 98% over a 14-month follow-up period - 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", Asia Pacific Journal of Cancer Prevention, 15(15), pp. 6005-6008, 2014. In the long term of 5 years, efficacy may be as low as 43% - see Flannelly, G., Bolger, B., Fawzi, H., Lopes, A. and Monaghan, JM, "Follow up after LLETZ: could schedules be modified according to risk of recurrence?", BJOG: International Journal of Obstetrics and Gynecology, 108(10), pp. 1025-1030, 2001. Eradication of diseased tissue is the goal of LEEP intervention. HPV virus remains present in 22% of patients after surgery, which is a factor contributing to the poor overall efficacy. This rate is similar to the recurrence of warts, another manifestation of HPV infection, which recurs in 30% after surgical intervention, see Lipke, MM, "An armamentarium of wart treatments", Clinical Medicine and Research, 4(4), pp. 273-293, 2006. HPV particles released during the intervention may also be a contributing factor, as the presence of HPV in the gas plume produced by the LEEP procedure is similar to laser ablation techniques and also requires 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.

[0015] Cryotherapy, also known as cryosurgery and cryoablation, uses extreme cold to destroy tissue. Ice crystals form in cells below a certain temperature, causing tears in the cell membrane, permanently damaging it, and killing the cell. The source of the cold can come from liquid nitrogen or other gases, and can be delivered through a needle to localize the impact. Strict health and safety guidelines are used to ensure that no unintended damage is caused to other patient tissue or the operator. Scarring is often an additional side effect of this procedure.

[0016] Laser therapy is an alternative ablative technique, whereby tissue can be destroyed by burning it using a focused CO2 laser, for example. This is a highly localised technique, although the penetration depth is significantly less than the effects of cryotherapy. The vaporisation action produces an aerosol or smoke plume which must be evacuated to prevent secondary infection of the patient and operator. The power of the laser means that destruction occurs within seconds, with the result that mistakenly directing the laser at healthy tissue or the operator's hand can result in an accident. Further operator risks arise from the laser's ability to bounce and reflect onto reflective surfaces, so the procedure can only be performed in special environments.

[0017] Is it known to use microwave energy to treat HPV infected tissue. It has been shown that microwave energy can easily penetrate deep into the epidermis to the dermis. The HPV virus is known to reside in the basal layer and replicate in the spinous and granular layers. In a similar manner, the epithelial layer of the cervix also carries HPV particles in the basal layer after abrasion of the upper squamous epithelium following infection. Summary of the invention

[0018] A person of ordinary skill in the art should understand that any feature of any of the devices, components, systems, or methods described herein may be applied alone or in any combination to any of the devices, components, systems, or methods described herein.

[0019] A microwave antenna device for radiating microwave energy into surface tissue of the cervix is ​​described herein, the device comprising:

[0020] a conductive grounding element defining an aperture;

[0021] an electrically conductive elongated member extending through the aperture and terminating at a distal end; and

[0022] one or more dielectric elements,

[0023] Wherein one or more of the dielectric elements electrically insulate the elongated element and the ground element from each other.

[0024] The microwave antenna device can be used to deliver microwave energy to a selected area of ​​the cervix, such as a selected area of ​​the cervix that has been previously identified as exhibiting cervical intraepithelial neoplasia (CIN).

[0025] The ground element and the elongate element may be coaxial. This may increase the efficiency of the transmission of microwave energy through the microwave antenna assembly to the surface tissue of the cervix.

[0026] One or more of the dielectric elements may define an outer surface for engaging a surface of the cervix.

[0027] One or more of the dielectric elements may cover the distal end of the elongate element.

[0028] One or more of the dielectric elements may cover the distal portion of the elongate element.

[0029] The elongated member may extend axially beyond the grounding member by a predetermined length, and the one or more dielectric members may cover a portion of the predetermined length of the elongated member.

[0030] The elongate element may extend axially beyond the ground element by a predetermined length, and one or more of the dielectric elements may cover the entire predetermined length of the elongate element.

[0031] One or more of the dielectric elements may be configured to prevent the elongate element from contacting the surface of the cervix when the microwave antenna device is in use. This may help to avoid burning or charring of surface tissue of the cervix.

[0032] One or more of the dielectric elements may be configured to separate the ground element and / or the elongate element from tissue of the surface of the cervix by a desired predetermined distance. For example, one or more of the dielectric elements may have a desired predetermined thickness.

[0033] The one or more dielectric elements may fill the aperture defined by the ground element.

[0034] The one or more dielectric elements may define a central distal feature for centering the antenna relative to the axis of the cervical os of the cervix.

[0035] The central distal feature can be configured to radiate microwave energy into the proximal region of the cervical os.

[0036] The one or more dielectric elements define a cup-shaped feature for cupping a proximal exocervical region of the cervix and preventing over-insertion of the central distal feature into the cervical os of the cervix.

[0037] The microwave antenna device may include a conductive cover element at or near the distal end of the elongated conductor. For example, the distal end of the outer surface of the microwave antenna device is defined by one or more of the dielectric elements, and the conductive cover element may be located between the distal end of the elongated conductor and the distal end of the outer surface of the microwave antenna device. Alternatively, the cover element may define the distal end of the outer surface of the microwave antenna device.

[0038] One or more of the dielectric elements may cover at least a portion of the ground element. This may prevent the ground element from contacting the surface of the cervix when the microwave antenna device is in use. This may help avoid burning or charring of the surface tissue of the cervix.

[0039] One or more of the dielectric elements may cover at least a portion of the distal surface of the ground element.

[0040] One or more of the dielectric elements may cover at least a portion of the distal surface of the ground element.

[0041] The microwave antenna arrangement may define an axis. For example, the microwave antenna arrangement may be cylindrically symmetric about the axis.

[0042] The elongate element may extend axially beyond the ground element by a predetermined length, such as a predetermined length less than or equal to 50 mm, between 5 mm and 15 mm, or substantially equal to 10 mm.

[0043] The elongate element may be rod-shaped. The elongate element may be cylindrical. The elongate element may be conical.

[0044] The radial extent of the grounding element may be greater or less than the radial extent of the dielectric element by a predetermined radial offset. The radial offset may be less than or equal to 20 mm, greater than or equal to 10 mm, or greater than or equal to 5 mm.

[0045] The grounding element may be annular or substantially annular. The grounding element may be planar or substantially planar. The grounding element may be curved. The grounding element may be shaped in the form of a cup or bowl, wherein the opening of the cup or bowl is directed toward the distal end of the elongated element. The grounding element may be shaped in the form of an inverted cup or inverted bowl, wherein the opening of the inverted cup or inverted bowl is directed away from the distal end of the elongated element.

[0046] The elongate member may include a proximal portion on a side of the ground element opposite the distal end of the elongate member.

[0047] The ground element may include a body portion and an outer conductor portion, wherein the outer conductor portion extends away from the body portion on opposite sides of the body portion to a distal end of the elongated element, and wherein the outer conductor portion of the ground element is coaxially arranged with a proximal portion 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 conductor portion of the ground element and to the elongated element.

[0048] The microwave antenna device may include an outer conductor electrically connected to the ground element on opposite sides of the ground element and extending from the ground element away from the ground element to the distal end of the elongated element, and wherein the outer conductor is coaxially arranged with the proximal portion of the elongated element. The outer conductor may be welded or fused to the ground element, the outer conductor may be electrically connected to the ground element using a conductive epoxy, and / or the outer conductor and the ground element may be mechanically connected, for example by a press fit. One or more of the dielectric elements may electrically insulate the outer conductor and the elongated element from each other. The microwave antenna device may include an electrical connector, for example a coaxial electrical connector, wherein the electrical connector is electrically connected to the outer conductor and the elongated element.

[0049] When the microwave antenna arrangement is positioned away from any other objects, the microwave antenna arrangement may be configured to provide a desired predetermined radiation pattern for one or more given characteristics of microwave energy such that the desired predetermined radiation pattern is not disturbed by the proximity of any other objects.

[0050] When the microwave antenna assembly is positioned away from the cervical surface, the microwave antenna assembly may be configured to provide a desired predetermined radiation pattern for one or more given characteristics of the microwave energy such that the desired predetermined radiation pattern is not disturbed by the proximity of the cervical surface.

[0051] When the microwave antenna arrangement is used to apply microwave energy to the cervix, the microwave antenna arrangement may be configured to provide a desired predetermined radiation pattern for one or more given characteristics of the microwave energy.

[0052] When the microwave antenna assembly is used to apply microwave energy to the cervix, the microwave antenna assembly may be configured to provide a desired therapeutic effect for one or more given characteristics of the microwave energy.

[0053] The microwave antenna arrangement may be configured to produce a correct biological response to one or more given characteristics of microwave energy in one or more regions of the cervix (eg, one or more infected regions).

[0054] For one or more given characteristics of the microwave energy, the microwave antenna device may have a relative dielectric constant that matches or substantially matches the relative dielectric constant of the cervical tissue. This may increase the efficiency of the microwave energy transmission to the cervical tissue. This may significantly reduce the risk of heating the microwave antenna device itself, and thereby reduce the risk of accidentally burning tissue, if the antenna contacts any adjacent tissue immediately after treatment.

[0055] For one or more given characteristics of the microwave energy, the relative permittivity of the microwave antenna device may be less than 50%, less than 10%, less than 1%, or less than 0.1% of the relative permittivity of cervical tissue.

[0056] The microwave antenna arrangement may be configured to cause localized non-ablative thermal therapy of surface tissue of the cervix for one or more given characteristics of the microwave energy.

[0057] The microwave antenna assembly may be configured to produce a biological response in one or more regions of surface tissue of a cervix infected with human papillomavirus (HPV) and / or diagnosed with cervical intraepithelial neoplasia (CIN) for one or more given characteristics of microwave energy.

[0058] The microwave antenna arrangement may be configured to cause localized ablation of surface tissue of the cervix for one or more given characteristics of the microwave energy.

[0059] The microwave antenna assembly may be configured to cauterize surface tissue of the cervix for one or more given characteristics of the microwave energy.

[0060] The one or more given characteristics of the microwave energy may include at least one of the frequency, spectrum, power, power density, energy, energy density, brightness, intensity, amount, amplitude, exposure time, dose, pulse duration, and pulse repetition rate of the microwave energy.

[0061] One or more given characteristics of the microwave energy may include a frequency within a range from about 500 MHz to about 200 GHz, within a range from about 900 MHz to about 100 GHz, or within a range from about 5 GHz to about 15 GHz.

[0062] One or more given characteristics of the microwave energy may include a frequency of about 8 GHz.

[0063] One or more given characteristics of the microwave energy may include a power of 0.1 W to 20 W.

[0064] One or more given characteristics of the microwave energy may include an exposure time in the range of 0.1 s to 30 s.

[0065] The microwave antenna arrangement may be configured to provide a predetermined radiation pattern for irradiating one or more predetermined regions of surface tissue of the cervix. The microwave antenna arrangement may be configured to provide a radiation pattern for irradiating one or more ectocervical regions of surface tissue of the cervix. The microwave antenna arrangement may be configured to provide a radiation pattern for irradiating one or more endocervical regions of surface tissue of the cervix.

[0066] The microwave antenna assembly may be disposable or reusable.

[0067] The microwave antenna device may include a microwave applicator.

[0068] A plurality of any of the above microwave antenna arrangements may be provided, each having a different configuration selected to provide a respective different radiation pattern.The radiation pattern may, for example, be selected to irradiate one or more respective exocervical and / or endocervical regions of surface tissue of the cervix.

[0069] The microwave antenna device may have an outer surface with different configurations. For example, the microwave antenna device may have an outer surface with different shapes and / or sizes. The microwave antenna device may have an elongated element and / or a ground element with different configurations.

[0070] The one or more dielectric materials may include any one or more of acrylonitrile butadiene styrene (ABS), nylon, polyethylene terephthalate (PET), polyimide, polypropylene, and polytetrafluoroethylene (PTFE).

[0071] A microwave assembly for radiating microwave energy into surface tissue of a cervix is ​​described herein, the microwave assembly comprising a shaft connected to any of the microwave antenna devices described above.

[0072] The microwave assembly may comprise a connection device connecting the shaft and the microwave antenna arrangement, wherein the connection device is configured to change an angle between an axis of the microwave antenna arrangement and an axis of the shaft.

[0073] The connection means may include a pivot means, a hinge, a flexible joint, a ball joint or the like.

[0074] Such a connection device may allow the microwave antenna device to be adjusted or oriented to align with the entrance to the cervix or the cervical opening. For example, such a connection device may allow the angle between the axis of the microwave antenna device and the axis of the shaft to be selected for axial alignment of the microwave antenna device with the cervical opening. After the microwave antenna device is inserted into the vagina, the direction of the microwave antenna device may be changed inside the vagina by adjusting the angle between the axis of the microwave antenna device and the axis of the shaft. Alternatively, before the microwave antenna device is inserted into the vagina, the direction of the microwave antenna device may be changed outside the vaginal canal by pre-adjusting the angle between the axis of the microwave antenna device and the axis of the shaft.

[0075] The alignment angle can be any fixed angle between 1 degree and 90 degrees.

[0076] The microwave antenna device can be configured, for example, to be sized and / or shaped to be inserted into and manipulated within the vagina. The microwave antenna device can be configured to be inserted into and manipulated within the vagina to reach one or more exocervical and / or endocervical regions of surface tissue of the cervix. The microwave antenna device can be configured to be inserted into the vagina and manipulated within the vagina by a colposcopist when the patient is in the dorsal lithotomy position.

[0077] The connection arrangement may be configured to removably attach the microwave antenna arrangement to the shaft, thereby allowing for fitting of different microwave antenna arrangements, which may have alternative configurations, such as alternative shapes and / or sizes.

[0078] The microwave assembly may include a handle or handpiece at or near its proximal end. For example, the microwave assembly may include a handle or handpiece at or near the proximal end of the shaft.

[0079] The handle or hand piece may be removably attached to the shaft. This may allow the handle or hand piece to be removed from the shaft. The microwave antenna device and shaft may be disposable, so that removing the handle or hand piece from the shaft may allow for disposal of the microwave antenna device and shaft. Alternatively, the microwave antenna device and shaft may be reusable, and removing the handle or hand piece from the shaft may allow for sterilization of the microwave antenna device and shaft prior to reuse.

[0080] The axis of the handle or handpiece and the shaft can be coaxial. The handle or handpiece can be arranged at a certain angle relative to the axis. For example, the handle or handpiece can be arranged at an angle of 30 degrees, 45 degrees or 90 degrees relative to the axis.

[0081] The handle or handpiece may be disposable or reusable.

[0082] The microwave assembly may include an electrical switch configurable between an on state in which the switch allows microwave energy to be transmitted from the microwave generator to the microwave antenna device and an off state in which the switch prevents microwave energy from being transmitted from the microwave generator to the microwave antenna device. The handle or handpiece may include a manual control element, such as a button or the like, for reconfiguring the electrical switch between the on and off states.

[0083] The microwave assembly may include an electrical connector, such as a coaxial electrical connector, to allow the microwave assembly to be electrically connected to the microwave generator via microwave waves. The microwave assembly may include an electrical connector, such as a coaxial electrical connector, to allow the microwave assembly to be electrically connected to the microwave generator via a microwave cable, such as a flexible and / or coaxial microwave cable. The electrical connector may, for example, be electrically connected to an electrical switch.

[0084] A microwave system for radiating microwave energy into surface tissue of the cervix is ​​described herein, the system comprising:

[0085] Microwave generator;

[0086] Any microwave component as described above; and

[0087] Microwave waveguide,

[0088] The microwave waveguide is connected to the microwave generator and the microwave component.

[0089] The microwave waveguide may include a microwave cable, such as a flexible and / or coaxial microwave cable.

[0090] The microwave waveguide may be hardwired, for example soldered or fused or secured to the microwave component with a conductive adhesive.

[0091] The microwave waveguide may be housed in the shaft. The shaft may provide mechanical support for the microwave waveguide.

[0092] The microwave assembly may include an electrical connector, such as a coaxial electrical connector, wherein the microwave waveguide is electrically connected to the electrical connector.

[0093] The microwave system may include a processing resource configured to control the microwave generator to select one or more characteristics of the microwave energy provided by the microwave generator.

[0094] The processing resources may be configured to control the microwave generator to provide a desired predetermined radiation pattern for one or more given characteristics of the microwave energy when the microwave antenna assembly is positioned away from any other object such that the desired predetermined radiation pattern is not disturbed by the proximity of any other object.

[0095] The processing resources may be configured to control the microwave generator to provide a desired predetermined radiation pattern for one or more given characteristics of the microwave energy when the microwave antenna assembly is positioned away from the cervical surface such that the desired predetermined radiation pattern is not disturbed by proximity of the cervical surface.

[0096] The processing resource may be configured to control the microwave generator to provide a desired predetermined radiation pattern for one or more given characteristics of the microwave energy when the microwave antenna assembly is used to apply the microwave energy to the cervix.

[0097] The processing resources may be configured to control the microwave generator so as to provide a desired therapeutic effect for one or more given characteristics of the microwave energy when the microwave antenna assembly is used to apply microwave energy to the cervix.

[0098] The processing resources may be configured to control the microwave generator to produce a correct biological response to one or more given characteristics of the microwave energy in one or more regions of the cervix (eg, one or more infected regions).

[0099] The processing resources may be configured to control the microwave generator so as to cause localized non-ablative thermal therapy of surface tissue of the cervix for one or more given characteristics of the microwave energy.

[0100] The processing resources may be configured to control the microwave generator to produce a biological response in one or more regions of surface tissue of a cervix infected with HPV and / or diagnosed with CIN for one or more given characteristics of the microwave energy.

[0101] The processing resources may be configured to control the microwave generator so as to cause localized ablation of surface tissue of the cervix for one or more given characteristics of the microwave energy.

[0102] The processing resources may be configured to control the microwave generator to cauterize surface tissue of the cervix for one or more given characteristics of the microwave energy.

[0103] The one or more given characteristics of the microwave energy may include at least one of the frequency, spectrum, power, power density, energy, energy density, brightness, intensity, amount, amplitude, exposure time, dose, pulse duration, and pulse repetition rate of the microwave energy.

[0104] One or more given characteristics of the microwave energy may include a frequency within a range from about 500 MHz to about 200 GHz, within a range from about 900 MHz to about 100 GHz, or within a range from about 5 GHz to about 15 GHz.

[0105] One or more given characteristics of the microwave energy may include a frequency of about 8 GHz.

[0106] One or more given characteristics of the microwave energy may include a power of 0.1 W to 20 W.

[0107] One or more given characteristics of the microwave energy may include an exposure time in the range of 0.1 s to 30 s.

[0108] A method for forming any of the microwave antenna arrangements described above is described herein.

[0109] The method may include forming one or more dielectric elements of the microwave antenna device by forming one or more dielectric materials at, on and / or around any or all of the conductive features of the microwave antenna device. Such a method may result in the conductive features of the microwave antenna device and the formed microwave antenna device being integral, thereby avoiding any requirement for assembly of the microwave antenna device.

[0110] The method may include forming the one or more dielectric elements using an injection molding process. The injection molding process may include injection molding one or more dielectric materials to form the one or more dielectric elements. Thus, lower costs and more efficient manufacturing may be achieved, particularly when manufacturing a large number of microwave antenna devices and / or shafts (such as a large number of disposable microwave antenna devices and / or shafts).

[0111] The injection molding process may include forming one or more dielectric materials at, on, and / or around the elongated element and / or the ground element.

[0112] The injection molding process may include forming one or more dielectric materials at, on, and / or around the dielectric material at least partially covering the elongated member and / or the grounding member.

[0113] The injection molding process may include forming one or more dielectric materials at, on, and / or around an existing component already present in the mold cavity. This process is known as overmolding. Such an existing component may include any or all features of the microwave antenna device.

[0114] One or more of the dielectric materials may include any one or more of acrylonitrile butadiene styrene (ABS), nylon, polyethylene terephthalate (PET), polyimide, polypropylene, and polytetrafluoroethylene (PTFE).

[0115] The method may include forming one or more dielectric components using cold pressing, wherein a powder form of one or more dielectric materials is compressed into a desired form by a stamping or extrusion process. Such a cold pressing process may be suitable for PTFE.

[0116] The method may include forming one or more dielectric components by machining, such as turning a solid body 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.

[0117] The method may comprise securing the microwave antenna arrangement to the shaft using an adhesive. For example, the method may comprise attaching the microwave antenna arrangement to the shaft using a cyanoacrylate adhesive and / or an epoxy adhesive.

[0118] The method may include securing the microwave antenna assembly to the shaft by heat fusing the microwave antenna assembly and the shaft together. Heat fusing may be an effective bonding method when the microwave antenna assembly and / or the shaft comprise a synthetic fluoropolymer material.

[0119] The method may include forming the ground element by at least one of electroplating, molding, pressing, 3D printing, attaching to a formed dielectric, depositing a conductive material on a 3D surface, and the like.

[0120] The ground element may include or be formed from one or more metals.

[0121] The elongate element may comprise or be formed from one or more metals.

[0122] The method may include 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 include welding or fusing the outer conductor and the ground element together. The method may include forming an electrical connection between the outer conductor and the ground element using a conductive epoxy. The method may include mechanically connecting the outer conductor and the ground element to form an electrical connection between the outer conductor and the ground element, such as by press fitting.

[0123] A method for radiating microwave energy into surface tissue of the cervix is ​​described herein, the method comprising:

[0124] engaging the surface of the cervix with the distal surface of any of the microwave antenna devices described above; and

[0125] Microwave energy is applied to the cervix using a microwave antenna device.

[0126] The method may include selecting one or more characteristics of the microwave energy to provide a desired predetermined radiation pattern when the microwave antenna assembly is positioned away from any other object, such that the desired predetermined radiation pattern is not disturbed by the proximity of any other object.

[0127] The method may include selecting one or more characteristics of the microwave energy to provide a desired predetermined radiation pattern when the microwave antenna assembly is positioned distal to the cervical surface such that the desired predetermined radiation pattern is not disrupted by proximity of the cervical surface.

[0128] The method may include selecting one or more of the frequency, spectrum, power, power density, energy, energy density, brightness, intensity, amount, amplitude, exposure time, dose, pulse duration, pulse repetition rate, etc. of the microwave energy to provide a desired predetermined radiation pattern.

[0129] The method may include selecting one or more characteristics of the microwave energy to provide a therapeutic effect when the microwave antenna assembly is used to apply the microwave energy to the cervix.

[0130] The method may include selecting one or more characteristics of the microwave energy to produce a proper biological response in one or more areas of the cervix (eg, one or more infected areas).

[0131] The method may include matching or substantially matching the relative dielectric constant of the microwave antenna device to the relative dielectric constant of the cervical tissue for one or more given characteristics of the microwave energy. This may increase the efficiency of the transmission of the microwave energy to the cervical tissue. This may significantly reduce the risk of heating the microwave antenna device itself, and thereby reduce the risk of accidentally burning tissue, if the antenna contacts any adjacent tissue immediately after treatment.

[0132] The method may include selecting a relative dielectric constant of the microwave antenna device that differs from the relative dielectric constant of cervical tissue by less than 50%, less than 10%, less than 1% or less than 0.1% for one or more given characteristics of the microwave energy.

[0133] The method may include selecting one or more of the spatial distribution, frequency, spectrum, power, power density, energy, energy density, brightness, intensity, amount, amplitude, exposure time, dose, pulse duration, pulse repetition rate, etc. of microwave energy to provide a therapeutic effect.

[0134] The method may include selecting a frequency of the microwave energy within a range from about 500 MHz to about 200 GHz, from about 900 MHz to about 100 GHz, or from about 5 GHz to about 15 GHz.

[0135] The method may include selecting a frequency of the microwave energy of about 8 GHz.

[0136] The method may include selecting a power of the microwave energy of 0.1 W to 20 W.

[0137] The method may comprise selecting an exposure time ranging from 0.1 s to 30 s.

[0138] The method may include selecting one or more characteristics of the microwave energy to cause localized non-ablative thermal therapy of surface tissue of the cervix.

[0139] The method may include selecting one or more of the spatial distribution, frequency, spectrum, power, power density, energy, energy density, brightness, intensity, amount, amplitude, exposure time, dose, pulse duration, pulse repetition rate, etc. of microwave energy to cause localized non-ablative thermal therapy of cervical surface tissue.

[0140] The method may include selecting one or more characteristics of the microwave energy to produce a biological response in one or more areas of surface tissue of the cervix infected with HPV and / or diagnosed with CIN.

[0141] The method may include selecting one or more of the spatial distribution, frequency, spectrum, power, power density, energy, energy density, brightness, intensity, amount, amplitude, exposure time, dose, pulse duration, pulse repetition rate, etc. of microwave energy so as to produce a biological response in one or more areas of surface tissue of the cervix infected with HPV and / or diagnosed with CIN.

[0142] The method may include selecting one or more characteristics of the microwave energy to cause localized ablation of surface tissue of the cervix.

[0143] The method may include selecting one or more of the spatial distribution, frequency, spectrum, power, power density, energy, energy density, brightness, intensity, amount, amplitude, exposure time, dose, pulse duration, pulse repetition rate, etc. of microwave energy to cause localized ablation of surface tissue of the cervix.

[0144] The method may include selecting one or more characteristics of the microwave energy so as to cauterize surface tissue of the cervix.For example, after a LEEP, cauterization of surface tissue of the cervix may be useful.

[0145] The method may include selecting one or more of the spatial distribution, frequency, spectrum, power, power density, energy, energy density, brightness, intensity, amount, amplitude, exposure time, dose, pulse duration, pulse repetition rate, etc. of microwave energy in order to cauterize surface tissue of the cervix. BRIEF DESCRIPTION OF THE DRAWINGS

[0146] Microwave antenna devices or applicators, microwave assemblies and microwave systems will now be described by way of non-limiting examples only, with reference to the following drawings, in which:

[0147] Figure 1 It is a schematic diagram of the human cervix;

[0148] Figure 2 This is a schematic diagram of the type I transformation zone of the human cervix;

[0149] Figure 3 is a schematic diagram of the type II transformation zone of the human cervix;

[0150] Figure 4 This is a schematic diagram of the type III transformation zone of the human cervix;

[0151] Figure 5 is a schematic diagram of a microwave system;

[0152] Figure 6 is a diagrammatic representation of the external features of a "Type A" microwave antenna arrangement designed to handle a Type I (T1) CIN transition zone;

[0153] Figure 7 is a diagrammatic representation of the external features of a "Type B" microwave antenna assembly designed to address the Type II (T2) CIN conversion region;

[0154] Figure 8 is a diagrammatic representation of the external features of a "C-type" microwave antenna device designed to address the Type III (T3) CIN conversion region;

[0155] Fig. 9 is an illustration of the external features of a "D-type" microwave antenna device, which may be a variation of a "C-type" antenna designed for use when atypical hyperplasia is present only at the opening of the cervix and continues into the cervical os;

[0156] Fig.10 is a diagram showing the external features of microwave antenna devices of type A, type B and type C;

[0157] Fig.11 It is a cross-sectional view of the types of microwave antenna devices of type A, type B, type C and type D applied to the cervix;

[0158] Fig.12 is a cross-sectional view of the internal features of microwave antenna device types A, B, C and D;

[0159] Fig.13 is a diagram of the distribution of electromagnetic and microwave fields, specifically, the distribution of electromagnetic and microwave fields in the cervix in the form of SAR (surface absorption rate) using microwave antenna devices of types A, B and C;

[0160] Fig.14 The scattering parameter S11, a mathematical construct that quantifies how RF energy propagates into tissue through a microwave antenna arrangement, is shown;

[0161] Fig.15is a diagram of the distribution of electromagnetic and microwave fields, specifically, the distribution of electromagnetic and microwave fields in the cervix in the form of SAR (surface absorption rate) using microwave antenna devices of types A, B and C in common, wherein a metal ground layer is in contact with the tissue;

[0162] Fig.16 is a diagram of the distribution of electromagnetic and microwave fields, specifically, the distribution of electromagnetic and microwave fields in the cervix in the form of SAR (surface absorption rate) using microwave antenna devices of types A, B and C in common, wherein the metal ground layer is not in contact with the tissue;

[0163] Fig.17 The effect of the critical total length of the center conductor of a microwave antenna device on the total energy distribution pattern of the microwave field achieved in a tissue constrained more toward a ground plane is shown;

[0164] Fig.18 The effect of the critical total length of the center conductor of a microwave antenna device on the total energy distribution pattern of the microwave field achieved in a tissue confined further away from a ground plane is shown;

[0165] Fig.19 The effect of the critical radial distance from the ground plane to the outer shape of the microwave antenna device on the total energy distribution pattern of the microwave field in the tissue is shown;

[0166] Fig. 20 The effect of the contours of the ground plane and microwave antenna device having equal diameters on the total energy distribution pattern of the microwave field in the tissue is shown;

[0167] Fig.21 The effect of the critical radial distance from the ground plane to the outer shape of the microwave antenna device on the total energy distribution pattern of the microwave field in the tissue is shown when the length of the central conductor is extended;

[0168] Fig. 22 The effect of equal ground plane diameter and shape of microwave antenna device on the total energy distribution pattern of microwave field in tissue when the length of center conductor is extended is shown;

[0169] Fig.23 The effect of a tapered ground plane of a microwave antenna device on the total energy distribution pattern of the electromagnetic field in tissue is shown;

[0170] Fig.24 The effect of an inverted cup-shaped ground plane of a microwave antenna device on the total energy distribution pattern of the electromagnetic field in tissue is shown;

[0171] Fig.25 The effect of a cup-shaped ground layer of a microwave antenna device on the total energy distribution pattern of the electromagnetic field in tissue is shown;

[0172] Fig.26The total energy distribution pattern of the microwave field in the tissue is shown when the ground layer of the microwave antenna device is not in contact with the tissue;

[0173] Fig. 27 The effect of a longer length of the central conductor of a microwave antenna device is shown, which shows a non-uniform total energy distribution pattern of the microwave field in the tissue, with a higher field towards the endocervix and a reduced field towards the ectocervix;

[0174] Fig.28 The effect of compensating for the extended length of the central conductor of a microwave antenna device by changing the shape of the central conductor on achieving a uniform total energy distribution pattern of the microwave field throughout the cervical region is shown; and

[0175] Fig.29 Shows Figure 5 Microwave components of a microwave system. DETAILED DESCRIPTION

[0176] A typical diagram of a healthy human cervix Figure 1 As shown. The cervix 1 includes an external portion in the form of an exocervix 2 and an endocervix 3, a tube connecting the uterine cavity 4 and the vaginal cavity 5. The opening of the cervix 1 in the vaginal cavity 5 is called the external os 6. The area where the endocervix 3 intersects the exocervix 2 is called the transformation zone (TZ) 7. This area is the most prone to CIN (cervical neoplasia) and is considered to be the most prone to abnormalities. Figure 2 is a schematic representation of a Type I transformation zone (TZ) 8, which is located entirely on the ectocervix, is fully visible, and can be small or large. Figure 3 A type II TZ 9 is shown in FIG. 9 that occupies the endocervical component but remains fully visible for small or large exocervical components. Figure 4 The Type III TS10 shown in FIG. 1 occupies an endocervical component, and the upper limit is not completely visible; if present, the exocervical component may be small or large.

[0177] Figure 5 A microwave system for treating cervical tissue is shown and is generally designated 100. Microwave system 100 includes a microwave generator 11 for providing microwave energy, a flexible interconnecting microwave cable such as a coaxial cable 12, a handle or handpiece 13, and a microwave antenna assembly 14.

[0178] like Fig.29As shown in more detail, the handle or handpiece 13 and the microwave antenna device 14 are connected by a shaft 202. The handle or handpiece 13, the microwave antenna device 14 and the shaft 202 together constitute a microwave assembly 200. The microwave assembly 200 is connected to the microwave generator 11 by a coaxial cable 12. The coaxial cable 12 extends through the shaft 202 between the handle or handpiece 13 and the microwave antenna device 14. The microwave assembly 200 also includes a connection device 204 for connecting the microwave antenna device 14 and the shaft 202. The connection device is configured to change the angle between the axis of the microwave antenna device 14 and the axis of the shaft 202. For example, the connection device 204 may include a pivot device, a hinge, a flexible joint, a ball joint, etc. Such a connection device 204 can allow the microwave antenna device 14 to be adjusted or oriented to align with the entrance or cervical ostium of the uterus. For example, such a connection device 204 can allow the angle between the axis of the microwave antenna device 14 and the axis of the shaft 202 to be selected for axial alignment of the microwave antenna device 14 with the cervical ostium. After the microwave antenna device 14 is inserted into the vagina, the direction of the microwave antenna device 14 can be changed in the vaginal cavity by adjusting the angle between the axis of the microwave antenna device 14 and the axis of the shaft 202. Alternatively, the direction of the microwave antenna device 14 can be changed outside the vaginal cavity by pre-adjusting the angle between the axis of the microwave antenna device 14 and the axis of the shaft 202 before inserting the microwave antenna device 14 into the vagina. For example, the alignment angle can be any fixed angle between 1 degree and 90 degrees.

[0179] The microwave antenna device 14 can be configured, for example, to be sized and / or shaped to be inserted into and manipulated within the vagina. The microwave antenna device 14 can be configured to be inserted into and manipulated within the vagina to reach one or more exocervical and / or endocervical regions of the surface tissue of the cervix. The microwave antenna device 14 can be configured to be inserted into the vagina and manipulated within the vagina by a colposcopist when the patient is in the dorsal lithotomy position.

[0180] The connection device 204 can be configured to removably attach the microwave antenna device 14 to the shaft 202, thereby allowing different microwave antenna devices to be assembled, which can have optional configurations, such as optional shapes and / or sizes. The connection device 204 may include an electrical connector (not shown), such as a coaxial electrical connector, to allow electrical connection / disconnection of the microwave antenna device 14 and the coaxial cable 12.

[0181] The handle or handpiece 13 may be removably attached to the shaft 202. This may allow the handle or handpiece 13 to be removed from the shaft 202. The handle or handpiece 13 may include an electrical connector (not shown), such as a coaxial electrical connector, to allow electrical connection / disconnection of the handle or handpiece 13 and the coaxial cable 12.

[0182] The microwave antenna assembly 14 and shaft 202 may be disposable, such that detaching the handle or handpiece 13 from the shaft 202 may allow for disposal of the microwave antenna assembly 14 and shaft 202. Alternatively, the microwave antenna assembly 14 and shaft 202 may be reusable, and detaching the handle or handpiece 13 from the shaft 202 may allow for sterilization of the microwave antenna assembly 14 and shaft 202 prior to reuse.

[0183] The handle or handpiece 13 is arranged at an angle relative to the axis of the shaft 202. For example, the handle or handpiece 13 can be arranged at an angle of 30 degrees, 45 degrees, or 90 degrees relative to the axis of the shaft 202, much like a "pistol grip".

[0184] The microwave assembly 200 also includes an electrical switch 206 that is configurable between an on state in which the switch 206 allows microwave energy to be transmitted from the microwave generator 11 to the microwave antenna assembly 14, and an off state in which the switch 206 prevents microwave energy from being transmitted from the microwave generator 11 to the microwave antenna assembly 14. The handle or handpiece 13 includes a manual control element, such as a button 208, for reconfiguring the electrical switch 206 between the on and off states.

[0185] The appearance of the microwave antenna assembly 14 can take many different shapes, depending on the desired TZ type and the processing area for the CIN. Figure 2 Treatment with TZ I, as shown in , in which only the lower external surface of the ectocervix is ​​disturbed by neoplasia 7 can be used Figure 6 A type microwave antenna device is shown in FIG. Figure 6 The microwave antenna device of type A shown is not required to treat the cervical os 6. Therefore, the central feature of the distal end 15 does not need to have a significant length and does not need to propagate microwave energy. The purpose of the central feature 15 is to provide a centering positioning aid for the user to ensure that the perimeter or diameter of the central feature 15 is in contact with the center / coaxial contact of the external cervix.

[0186] When treatment Figure 3 In the case of TZ II CIN shown, there is a combination of visible ectocervical and endocervical areas with neoplasia 8, so Figure 7 The B-type microwave antenna device shown in FIG. 1 has a radiation center feature 16 that is used not only to position the microwave antenna device relative to the cervix, but also to deliver energy to the proximal portion of the cervical opening 6, such as the anterior 3 mm.

[0187] When to treat Figure 4 In the case of TZ III CIN as shown in , there is neoplasia in the visible ectocervical area as well as in the visible or invisible endocervical area 9. Figure 8The C-type microwave antenna device has a radiation center feature 17, which is used not only to position the microwave antenna device relative to the cervix, but also to deliver energy to the endocervical area, which is farther away than the endocervical area treatable with the B-type microwave antenna device.

[0188] In this case, since the patient has no or very minimal ectocervical CIN and the atypical hyperplasia is only present at the opening of ostium 6 and continues into ostium 6, a Fig. 9 The D-type microwave antenna device shown in FIG. Fig. 9 The D-type microwave antenna arrangement shown in , for example, may be a variation of the C-type microwave antenna arrangement. Here, the D-type microwave antenna arrangement comprises a central feature 18 which is configured to radiate microwave energy primarily in a radial direction.

[0189] The external features of any type of microwave antenna device 14 are formed to accommodate a range of anatomical types that may vary between patients. There are Type A, Type B and Type C. Fig.10 The form shown, which may be tapered or parallel along the long axis, has a rounded distal end 19 for centering the antenna relative to the axis of the cervical os 6. Common to Types A, B, and C is a rounded cup feature 20 that prevents over-insertion in the cervical os 6 and matches the form of a typical proximal exocervix 2. The overall diameter of the antenna 21 is also designed to match the typical diameter of this same area, and the overall diameter of the antenna 21 should not interfere with the operation of the speculum and / or viewing the cervix through a colposcope. The approach angle of the microwave antenna device 14 to the cervix is ​​determined by a combination of the angle of the axis of the shaft 202 of the microwave assembly 200 controlled by the operator relative to the patient and the angle of the axis of the microwave antenna device 14 (determined by the shaft 22 on which the microwave antenna device 14 is mounted). The approach angle is set so that the axis of the microwave antenna device and the axis of the os are colinear. This can be used to ensure that the forward-facing distal side of the microwave antenna device 14 engages the cervix evenly, thereby being evenly exposed to microwave energy and therefore evenly treated. As will be described in more detail below, the non-conductive coating 23 covers any exposed metal parts forming the microwave assembly 200. This can reduce the risk of high intensity electromagnetic fields that may cause unintentional burning / deposition of energy when microwave energy is radiated from the microwave antenna device 14. The coating 23 is made of a biocompatible, substantially electromagnetically transparent material, such as polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), or fluoroethylene polymer (FEP) or other copolymer coatings. The length and diameter of the shaft 202 are designed to allow the user to move easily when opening the vagina with a speculum without obscuring the user's view through the colposcope.

[0190] The cross-sectional view of the microwave antenna device 14 of type A, type B and type C is shown in FIG. Fig.11The antenna is applied through air 26 to the cervical tissue 25 .

[0191] Fig.12 1 shows a cross section of a common microwave antenna device 14 of type A, type B and type C. In addition to the cup-shaped feature, the microwave antenna device of type D has the same Fig.12 The microwave antenna device 14 includes a conductive elongated element in the form of a center conductor 30 and a conductive grounding element in the form of an antenna grounding layer 31. The antenna grounding layer 31 defines a hole 31a through which the center conductor 30 extends. The microwave antenna device 14 also includes a dielectric element 33 that covers at least a portion of a distal or forward surface of the antenna grounding layer 31 and defines an outer distal or forward surface or form of the microwave antenna device 14. The dielectric element 33 also insulates the center conductor 30 from the antenna grounding layer 31, wherein the center conductor 30 passes through the hole of the antenna grounding layer 31.

[0192] The coaxial cable 27 is formed of an outer conductor in the form of a conductive outer shield 28, an additional dielectric element 29, and a center conductor 30. The outer shield 28 is connected to the antenna ground layer 31 with good integrity to ensure that all energy is transmitted to the desired area. Failure to achieve this may result in less efficient energy propagation and non-uniform fields that may result in non-uniform treatment areas. It will be understood by a person of ordinary skill in the art that the coaxial cable 12 may extend through the axis 202 of the microwave assembly 200, and the center conductor 30 and the outer shield 28 of the microwave antenna device 14 may be electrically connected to the corresponding center conductor (not shown) and corresponding shield (not shown) of the coaxial cable 12. The microwave antenna device 14 also includes an insulating support sheath 32 on the outer surface of the outer shield 28.

[0193] Another dielectric element in the form of dielectric support features 34 provides additional support and serves to avoid contact between the ground layer 31 and the tissue of the cervix.A further dielectric element in the form of an outer sheath 35 provides additional support and insulation to the ground layer 31 .

[0194] Any one or more of the dielectric elements 32, 33, 34, and 35 may include or be formed of any low-loss biocompatible material. For example, any one or more of the dielectric elements 32, 33, 34, and 35 may include or be formed of at least one of acrylonitrile butadiene styrene (ABS), nylon, polyethylene terephthalate (PET), polyimide, polycarbonate, PC-ABS, polypropylene, ceramics such as alumina, and FEP.

[0195] Any one or more of dielectric elements 32 , 33 , 34 , and 35 may include or be formed from the same material.

[0196] The center conductor 30 and the ground layer 31 may include or be formed of a metal such as copper, stainless steel, nickel, or the like.

[0197] A variety of different microwave antenna devices have been simulated using 3D simulation models. In this case, the simulation model is HFSS (Ansoft Corp), which is a finite element method (FEM) based full-wave electromagnetic solver. The simulation allows the calculation of coupling efficiency and predicted response of specific absorption rate (SAR). SAR is a measure of the rate at which the human body absorbs energy when exposed to radio frequency (RF) electromagnetic fields.

[0198] Fig.13 3 is a representation of the distribution of a microwave field into tissue 37, such as cervical tissue, using a microwave antenna device 36. The microwave antenna device 36 is mounted into the endocervical canal 38 of the cervix. The portion of the microwave antenna device 36 that is not engaged with the tissue 37 is modeled as air 39. The SAR field distribution 40 of the microwave field is shown using a grayscale image 41. The scattering parameter S11 response that quantifies how RF energy propagates into the tissue through the microwave antenna device is in Fig.14 The operating frequency of the microwave field is plotted on the X-axis and the S11 or return loss in decibels is shown on the Y-axis. The graph shows that over 99% of the energy is delivered to the tissue at 8 GHz, indicating that the antenna 36 and tissue 37 are very well matched at 8 GHz.

[0199] The operating frequency of microwave energy plays a fundamental role in determining the depth of tissue penetration and the size of the overall treatment zone. 8 GHz is a frequency that provides a good balance of energy penetration density for a given power. Frequencies less than 8 GHz may penetrate too deeply. Frequencies greater than 8 GHz may not penetrate deep enough for a proper biological response.

[0200] Fig.15 The situation is shown when tissue is in contact with a metal ground plane 42 showing the SAR field 43. The high concentration electric field at the metal-tissue interface can lead to subsequent charring and tissue burns. Fig.16 SAR field 44 is shown for a microwave antenna device including a dielectric element 45 covering a portion of a metallic ground layer to avoid any metal-tissue interface between the tissue and the metallic ground layer and providing a Fig.15 A safer solution than the SAR field 44 which is distributed less coaxially.

[0201] refer to Fig.17The total length 46 of the center conductor 47 protruding axially from the ground plane 48 is critical to achieving the overall energy transmission mode into the tissue. For example, in a D-type microwave antenna device, the center conductor 47 extends a predetermined length 46 from the ground plane 48. Fig.17 The SAR field distribution pattern 49 is shown when the center conductor 47 protrudes axially 10 mm from the ground layer 48. The SAR field distribution pattern 49 shows that the field is stronger toward the ground layer. This may be beneficial for treating volumes entering the ectocervical region. Fig.18 In the embodiment shown in FIG. 5 , when the length of the center conductor 50 is 15 mm, the field 51 can be pulled more toward the proximal region or away from the ground plane. This can be used when treating type II or type III TZ CIN that occupies an internal cervical component.

[0202] Fig.19 It shows how the radial offset distance 52 between the radial extent of the ground plane 53 and the radial extent or radial outer contour of the outer shape 54 is critical to achieving an overall stronger distally extending energy distribution pattern 55 into the tissue. The center conductor 56 can have a certain length, such as 10 mm. Fig. 20 In the figure, the diameters of the outer shape 57 and the ground plane 58 are the same, which indicates that Fig.19 The field migrates away from the ground layer 59 when compared to the field 55 shown in FIG. Fig. 20 The microwave antenna device can be used to treat different types of TZCIN that have or do not have endocervical and exocervical components.

[0203] Fig.21 It is shown how the effect of the varying radial offset distance 60 between the radial extent of the ground plane 61 and the radial extent of the profile 62 of the microwave antenna device can be compensated by extending the length of the center conductor 56. Specifically, Fig.21 The SAR field is shown for a radial offset 60 between the ground plane 61 and the contour 62, which is the same as the radial offset 52 and is greater than the radial offset 52 at the center conductor 63. Fig.19 The center conductor 56 is shown protruding further out of the ground plane. The field 64 is confined away from the ground plane 61.

[0204] Fig. 22 The diagram shows a schematic diagram without any radial gap between the ground plane 65 and the outer shape 66. Fig.21 Despite the different radial distances, the fields 64 and 67 are almost identical in terms of distribution area. This can also mean that in the case where the extended center conductor takes over the field distribution pattern over the radial distance difference between the profile and the ground plane.

[0205] The grounding layer can have different shapes to distribute different shapes of electromagnetic fields into the tissue, which in turn can be used to treat different types of TZ neoplasia. Fig.23 FIG. 4 shows a conical grounding layer 68 which can transmit more energy 69 to the endocervical component 3 of the cervix 1, while Fig.24 The inverted cup-shaped ground plane 70 shown in FIG. 1 may radiate more energy near the ground plane, ie, radiate more of the SAR field 71 into the ectocervical component of the cervix.

[0206] Fig.25 Another version of the ground layer 72 is shown having a cup-shaped structure that can spread and draw radiation 73 further into the ectocervical component of the cervix.

[0207] if Fig. 20 If the ground layer of the microwave antenna device is in contact with the tissue, this may result in high electromagnetic fields, which may cause charring of the tissue. Fig.26 As shown, the antenna is pulled back away from the tissue, thereby avoiding any possibility of the ground layer 74 contacting the tissue 75, and no change in the radiated field 76 is shown compared to 59.

[0208] Fig. 27 It is shown how the shape of the center conductor, especially a center conductor with an extended length, can affect the distribution of the field. Fig. 27 A center conductor 77 having a length of 20 mm is shown, which shows a non-uniform field pattern 78 that may radiate more into the endocervical component of the cervix. Fig.28 By thickening the center conductor 79 at the base and tapering it toward the top, the field 80 can be evenly aligned and transmitted along the entire length of the cervix in cases of advanced CIN.

[0209] Those skilled in the art will appreciate that various modifications may be made to any of the above described devices, assemblies, or systems. For example, to limit axial propagation of energy, a conductive cover element may be included 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 cover element may be located between the distal end of the elongated conductor and the distal end of the outer surface of the microwave antenna device. Alternatively, the cover element may define the distal end of the outer surface of the microwave antenna device.

[0210] The conductive shield of the coaxial cable may include two components. For example, the conductive shield of the coaxial cable may include a mesh or braid of conductive material and a foil wrap. The foil wrap may supplement the mesh or braid.

[0211] The coaxial cable may include a coating. The coating may include any suitable insulating material, such as PTFR, PEEK, FEB, or polyparaxylene. Such a coating may increase robustness. Such a coating may reduce friction to enhance the ease with which the cable slides relative to another object.

Claims

1. A microwave antenna device for radiating microwave energy into surface tissue of a cervix, the microwave antenna device comprising: a conductive grounding element defining an aperture; an electrically conductive elongated member extending through the aperture and terminating at a distal end; as well as one or more dielectric elements, wherein one or more of the dielectric elements electrically insulate the elongated element and the ground element from each other, wherein one or more of the dielectric elements define an outer surface of the microwave antenna device for engaging with a surface of the cervix, wherein the one or more dielectric elements define a central distal feature for centering the microwave antenna assembly relative to an axis of the cervical os of the cervix, and Wherein, the one or more dielectric elements define a cup-shaped feature for covering a proximal exocervical region of the cervix and preventing over-insertion of the central distal feature into the cervical os of the cervix.

2. The microwave antenna device according to claim 1, wherein: The ground element and the elongated element are coaxial.

3. A microwave antenna device as claimed in claim 1 or 2, wherein one or more of the dielectric elements covers the distal end of the elongated element, And / or wherein one or more of the dielectric elements covers a distal portion of the elongate element.

4. The microwave antenna device according to claim 1 or 2, wherein: The elongated element extends axially beyond the grounding element by a predetermined length.

5. The microwave antenna device according to claim 4, wherein: one or more of the dielectric elements covers a portion of the predetermined length of the elongated element, Alternatively one or more of said dielectric elements covers the entire said predetermined length of said elongated element.

6. The microwave antenna device according to claim 1 or 2, wherein: One or more of the dielectric elements are configured to prevent the elongate element from contacting a surface of the cervix when the microwave antenna arrangement is in use.

7. The microwave antenna device according to claim 1 or 2, wherein: One or more of the dielectric elements are configured to separate the ground element and / or the elongate element from tissue of the surface of the cervix by a desired predetermined distance.

8. The microwave antenna device according to claim 1 or 2, wherein: The one or more dielectric elements fill the aperture defined by the ground element.

9. The microwave antenna device according to claim 1 or 2, wherein: The central distal feature is configured to radiate microwave energy into a proximal region of the cervical os.

10. The microwave antenna device according to claim 1 or 2, wherein: One or more of the dielectric elements covers at least a portion of the ground element.

11. The microwave antenna device according to claim 1 or 2, wherein: One or more of the dielectric elements covers at least a portion of a distal surface of the ground element.

12. The microwave antenna device according to claim 1 or 2, wherein: The microwave antenna device defines an axis, and the microwave antenna device is cylindrically symmetric about the axis.

13. The microwave antenna device according to claim 12, wherein: The elongated element is rod-shaped.

14. The microwave antenna device according to claim 12, wherein: The radial extent of the grounding element is greater or less than the radial extent of the one or more dielectric elements by a predetermined radial offset.

15. The microwave antenna device according to claim 12, wherein at least one of the following is present: The grounding element is generally annular; The ground element is substantially planar; The grounding element is curved; The grounding element is shaped in the form of a cup or bowl, the opening of the cup or bowl pointing toward the distal end of the elongated element; and The grounding element is shaped in the form of an inverted cup or an inverted bowl, the opening of which is directed away from the distal end of the elongated element.

16. A microwave antenna device as claimed in claim 1 or 2, comprising a conductive cover element at the distal end of the elongate conductor.

17. The microwave antenna device according to claim 16, wherein: The distal end of the outer surface of the microwave antenna device is defined by one or more of the dielectric elements, and the conductive cover element is located between the distal end of the elongated conductor and the distal end of the outer surface of the microwave antenna device.

18. The microwave antenna device according to claim 1 or 2, wherein: The microwave antenna device is configured to radiate microwave energy into the surface tissue of the cervix for at least one of: so as to provide a therapeutic effect in one or more regions of said cervix; Local non-ablative thermal treatment of the surface tissue of the cervix; localized ablation of said surface tissue of said cervix; as well as Cauterization of the surface tissue of the cervix.

19. The microwave antenna device according to claim 1 or 2, comprising a plurality of microwave antenna devices, wherein: Each microwave antenna arrangement has a different configuration selected to provide a corresponding different radiation pattern.

20. A microwave assembly for radiating microwave energy into surface tissue of a cervix, the microwave assembly comprising the microwave antenna device according to any one of claims 1 to 19 and a shaft connected to the microwave antenna device.

21. The microwave assembly of claim 20, comprising connection means connecting the shaft and the microwave antenna arrangement, wherein the connection means is configured to change the angle between the axis of the microwave antenna arrangement and the axis of the shaft.

22. The microwave assembly of claim 21, wherein: The connecting means comprises pivot means.

23. The microwave assembly of claim 21, wherein: The connection arrangement is configured to removably attach the microwave antenna arrangement to the shaft, thereby allowing a different microwave antenna arrangement to be fitted to the shaft, wherein the different microwave antenna arrangement has a different configuration than the microwave antenna arrangement.

24. The microwave assembly of claim 21, wherein: The shaft is disposable or the shaft is reusable.

25. The microwave assembly of claim 20, comprising a hand piece at the proximal end of the shaft.

26. The microwave assembly of claim 25, wherein: The handpiece is removably connected to the shaft.

27. The microwave assembly of claim 25, wherein: The handpiece may be disposable or reusable.

28. The microwave assembly of claim 20, comprising an electrical switch configurable between an on state in which the switch allows microwave energy to be transmitted from the microwave generator to the microwave antenna assembly and an off state in which the switch prevents microwave energy from being transmitted from the microwave generator to the microwave antenna assembly.

29. The microwave assembly of claim 28, wherein: A handpiece is included at the proximal end of the shaft, the handpiece including a manual control element for reconfiguring the electrical switch between the on state and the off state.

30. A microwave system for radiating microwave energy into surface tissue of a cervix, the system comprising: A microwave assembly as claimed in any one of claims 20 to 29; Microwave generator; as well as Microwave waveguide, The microwave waveguide is connected to the microwave generator and the microwave component.

31. The microwave system of claim 30, wherein: The microwave waveguide includes a microwave cable.

32. The microwave system of claim 31, wherein: The microwave waveguide is received in the shaft.

33. The microwave antenna device according to claim 7, wherein: One or more of the dielectric elements has a desired predetermined thickness.

34. The microwave assembly of claim 23, wherein: The different microwave antenna arrangement has a different shape and / or size than the microwave antenna arrangement.

35. The microwave antenna device of claim 13, wherein the elongated element is cylindrical and / or conical.

36. The microwave antenna device according to claim 15, wherein at least one of the following is present: The grounding element is annular; or The ground element is planar.

37. The microwave antenna device of claim 18, wherein the microwave antenna device is configured 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 infected with human papillomavirus (HPV) and / or diagnosed with cervical intraepithelial neoplasia (CIN).

38. The microwave assembly of claim 29, wherein the manual control element comprises a button.

39. The microwave system of claim 31, wherein the microwave cable is flexible and / or coaxial.

40. The microwave assembly of claim 22, wherein the pivot means comprises a hinge or a flexible joint.

41. The microwave assembly of claim 22, wherein the pivot means comprises a ball joint.

42. The microwave assembly of claim 25, wherein the handpiece comprises a handle.

Images