TWI586314B - Apparatus for remodeling a therapeutic zone within tissue underlying a mucosal epithelium of female genital tissue - Google Patents

Description

用於重塑女性生殖組織之黏膜上皮下面的組織內之治療區之設備 Apparatus for reshaping a treatment area within a tissue beneath the mucosal epithelium of a female reproductive tissue

本發明一般而言係關於用於(諸如)藉由施加輻射能量來重塑***及外陰之組織之方法、裝置及系統。 The present invention relates generally to methods, devices, and systems for reshaping tissue of the vagina and vulva, such as by application of radiant energy.

作為一般程序，本文中所參照之所有出版物及專利申請案皆以其全文以引用方式併入，其引用程度如同具體且個別地指示每一個別出版物或專利申請案以引用方式併入。 All publications and patent applications, which are hereby incorporated by reference in their entirety in their entirety herein in theties in theties

***係由三層組成：複層鱗片狀上皮組織黏膜；黏膜下層或固有層，其含有血管化結締組織；及較深肌肉，其含有平滑肌。膠原分子係由駐留於此等組織中之細胞產生，該等細胞合成彼此纏繞之三個多肽鏈以形成三螺旋。膠原係一主要類型之纖維蛋白質，其為結締組織、腱、軟骨及骨之一基本結構元素。膠原鏈中之每一者在長度上係約1000氨基酸單元，其中甘氨酸每第三個單位有規律地重現，且其中脯氨酸及羥基脯氨酸極頻繁地重現。交叉鏈接發生於膠原分子之側而非端之間且與氨基酸成分耦合以將其較大強度給予膠原。膠原組織變緊沿平行於膠原纖維之一軸線之一方向發生。 The vaginal system consists of three layers: a stratified squamous epithelial tissue mucosa; a submucosal or lamina propria, which contains vascularized connective tissue; and a deeper muscle that contains smooth muscle. Collagen molecules are produced by cells resident in tissues such as these that synthesize three polypeptide chains entangled with one another to form a triple helix. Collagen is a major type of fibrous protein that is one of the basic structural elements of connective tissue, tendon, cartilage, and bone. Each of the collagen chains is about 1000 amino acid units in length, with glycine being regularly reproduced every third unit, and wherein proline and hydroxyproline are highly frequently reproduced. Cross-linking occurs on the side of the collagen molecule rather than between the ends and is coupled to the amino acid component to give it greater strength to the collagen. Collagen tissue tightening occurs in a direction parallel to one of the axes of one of the collagen fibers.

膠原之熱收縮現象以膠原分子之三螺旋之一變性開始。膠原組織之局部變性產生富膠原空間之收縮且提供對上覆組織之一「變緊」效應。與膠原變性及對此之利用(出於醫療或美容目的)之態樣相關之專利包括：頒發給Knowlton之美國專利5,919,219「Method for Controlled Contraction of Collagen Tissue Using RF Energy」及頒發給Knowlton之5,755,753「Method for Controlled Contraction of Collagen Tissue」；以及頒發給Fellner之美國專利5,143,063「Method of Removing Adipose Tissue」。 The heat shrinkage of collagen begins with denaturation of one of the three helices of collagen molecules. Local denaturation of collagenous tissue creates a contraction of the collagen-rich space and provides a "tightening" effect on one of the overlying tissues. Patents relating to collagen denaturation and its use (for medical or cosmetic purposes) include: US Patent 5,919,219 issued to Knowlton, "Method for Controlled Contraction of Collagen Tissue Using RF Energy and 5,755,753 "Method for Controlled Contraction of Collagen Tissue" issued to Knowlton; and US Patent 5,143,063 "Method of Removing Adipose Tissue" issued to Fellner.

進一步專利及公開專利申請案包括頒發給Knowlton之美國專利6,350,276「Tissue Remodeling Apparatus Containing Cooling Fluid」；頒發給Knowlton之美國專利6,387,380「Apparatus for Controlled Contraction of Collagen Tissue」；頒發給Knowlton之美國專利6,425,912「Method and Apparatus for Modifying Skin Surface and Soft Tissue Structure」；頒發給Knowlton之美國專利6,453,202「Apparatus for Tissue Remodeling」；頒發給Knowlton之美國公開案2002/0049483「Fluid Delivery Apparatus」；頒發給Knowlton之美國公開案2003/0212393「hand piece with RD Electrode and Non-Volatile Memory」；頒發給Knowlton之美國公開案2003/0236487「Method for Treatment of Tissue with Feedback」；及頒發給Knowlton之美國公開案2004/0000316「Methods for Creating Tissue Effect Utilizing Electromagnetic Energy and a Reverse Thermal Gradient」。 Further patents and published patent applications include US Patent 6,350,276 "Tissue Remodeling Apparatus Containing Cooling Fluid" issued to Knowlton; US Patent 6,387,380 "Apparatus for Controlled Contraction of Collagen Tissue" issued to Knowlton; US Patent 6,425,912 "Method issued to Knowlton" And Apparatus for Modifying Skin Surface and Soft Tissue Structure"; US Patent 6, 453, 202 "Apparatus for Tissue Remodeling" issued to Knowlton; US Publication 2002/0049483 "Fluid Delivery Apparatus" issued to Knowlton; US Publication 2003 issued to Knowlton /0212393 "hand piece with RD Electrode and Non-Volatile Memory"; issued to Knowlton, US Publication 2003/0236487, "Method for Treatment of Tissue with Feedback"; and issued to Knowlton, US Publication 2004/0000316 "Methods for Creating Tissue Effect Utilizing Electromagnetic Energy and a Reverse Thermal Gradient".

婦女之***組織在***產兒期間拉伸；拉伸之至少某些效應為永久性的且諸多婦女具有長期醫療後果。某些後果包括身體問題，諸如子宮下垂、膀胱突出、尿道憩室、腸疝、脫肛、壓力性尿失禁、排便問題，可利用外科選項來解決此等問題。某些後果可包括性方面，如可因***及其 開口(***口)之過度鬆弛而引起。此鬆弛通常隨第一次***分娩而發生，且該鬆弛往往隨後續***分娩而增加。此領域中之此鬆弛效應可包括***期間之降低之壓力及摩擦且因此對於婦女及其婚姻伴侶而言之降低之性愉悅。可運用某些外科選項，以試圖減輕此等問題，但外科方法可給其帶來一創傷風險，此對所期望之結果完全起反作用。更一般而言，由於與一敏感區域中之一侵入性程序相關聯之風險，尤其當此等程序被視為在醫療上可選時，此等外科方法並非高度受歡迎。 Women's vaginal tissue stretches during vaginal delivery; at least some of the effects of stretching are permanent and many women have long-term medical consequences. Some of the consequences include physical problems such as uterine prolapse, bladder protrusion, urethral diverticulum, intestinal fistula, rectal prolapse, stress urinary incontinence, defecation problems, and surgical options can be used to address these issues. Some consequences can include sexual aspects, such as the vagina and its Caused by excessive relaxation of the opening (vaginal opening). This relaxation usually occurs with the first vaginal delivery, and this relaxation often increases with subsequent vaginal delivery. This relaxation effect in this area may include reduced stress and friction during sexual intercourse and thus reduced sexual pleasure for women and their marital partners. Certain surgical options may be employed in an attempt to alleviate such problems, but surgical methods may present a risk of trauma, which is completely counterproductive to the desired outcome. More generally, such surgical methods are not highly popular due to the risks associated with an invasive procedure in a sensitive area, especially when such procedures are considered medically selectable.

用於治療***之已知系統及裝置達不到最佳，包括使用輻射能量來修復膠原之彼等系統及裝置。特定而言，已知系統對於裝置之操縱非最佳化，包括能量施加器(例如，手柄、施加器等)及所治療組織之冷卻。另外，現存系統可能不會最佳地調節與患者之組織之接觸。最後，已知系統尚未證明係使用簡單、重量輕且直觀的。本文中闡述系統、裝置及使用該等系統、裝置來重塑並治療***、***口及外陰之黏膜表面之方法。 Known systems and devices for treating the vagina are not optimal, including systems and devices that use radiant energy to repair collagen. In particular, known systems are not optimized for manipulation of the device, including energy applicators (eg, handles, applicators, etc.) and cooling of the treated tissue. In addition, existing systems may not optimally adjust contact with the patient's tissue. Finally, known systems have not proven to be simple to use, lightweight and intuitive. Systems, devices, and methods of using such systems and devices to reshape and treat mucosal surfaces of the vagina, vaginal opening, and vulva are described herein.

因此，需要藉助一非侵入性程序治療鬆弛***及***口之有效方法，且特定而言需要簡化並改良該治療之系統及裝置，特定而言在施加RF能量時。相應地，本發明之一個目的係提供用於***、***口及外陰之黏膜表面之矯正性或恢復性重塑之系統(包括設備及裝置)及方法。 Thus, there is a need for an effective method of relaxing the vagina and vaginal opening with a non-invasive procedure, and in particular, systems and devices that simplify and improve the treatment, particularly when RF energy is applied. Accordingly, it is an object of the present invention to provide a system (including apparatus and apparatus) and method for corrective or restorative remodeling of mucosal surfaces of the vagina, vaginal opening and vulva.

本文中闡述用於重塑目標組織(包括下伏於女性生殖組 織之黏膜上皮下面的固有層及肌肉)之裝置及系統以及用於使用此等裝置及系統來重塑組織之方法。一種此類裝置通常包括一手持件及一治療尖端，且可形成包括該裝置、一冷卻劑源及用於控制該手持件及尖端之一電子(例如，控制)系統以及一電源之一系統之一部分。該治療尖端之實施例可包括將該尖端連接至該手持件之一連接器部分、一中間區段(其可係變窄的)及包括一能量遞送元件之一遠端部分。該治療尖端亦可包括界定一內部空間之一管腔或外殼。該內部空間通常容納一冷卻系統，其具有用於傳送一冷卻劑(例如，一製冷流體)之一管腔及若干施加器(例如，噴嘴)，該等噴嘴經調適以將冷卻劑噴灑至該能量遞送元件之內部側上從而使其冷卻，如此，該經冷卻之內部側又使所接觸之一生殖黏膜上皮表面冷卻。該裝置亦可包括用於移除或排放該冷卻劑之一冷卻劑移除線路。 Described in this paper for reshaping target tissues (including underlying female reproductive groups) Apparatus and system for delamination of the lamina propria and muscles beneath the mucosal epithelium and methods for reshaping tissue using such devices and systems. One such device typically includes a handpiece and a treatment tip and can be formed to include the device, a source of coolant, and an electronic (eg, control) system for controlling the handpiece and tip and a system of one of the power sources portion. Embodiments of the treatment tip can include attaching the tip to one of the connector portions of the hand piece, an intermediate section (which can be narrowed), and including a distal end portion of an energy delivery element. The treatment tip can also include a lumen or housing defining an interior space. The interior space typically houses a cooling system having a lumen for delivering a coolant (eg, a refrigeration fluid) and a plurality of applicators (eg, nozzles) that are adapted to spray coolant to the chamber The inner side of the energy delivery element is thereby allowed to cool, such that the cooled inner side cools one of the genital mucosal epithelial surfaces in contact. The apparatus can also include a coolant removal line for removing or discharging the coolant.

本文中所闡述之該等裝置可經組態以與一手柄(手持件)配對。該手柄可係細長的，以使得其可沿與尖端相同的軸線被抓握及操縱，以***至***區中。該手柄可經調適以在遠端包括用於尖端之快速釋放耦合(例如，電耦合、冷卻劑輸入線路耦合、冷卻劑輸出線路耦合、感測器耦合等)。該手柄之近端可包括一軟線、電纜或其他連接器，以連接至控制器及/或供電源。在某些變化形式中，該手柄經組態以供雙手(例如，兩隻手)抓握。該手柄亦可經組態以使得其不包括用以啟動RF能量之遞送之一控制(開關、按鈕等)；而是，RF能量之遞送可藉由一腳踏開關或 其他不用手的開關來遞送。此可增強對施加器之把握之簡易性，即使在其旋轉並重新定位以到達體內之目標組織時。 The devices set forth herein can be configured to mate with a handle (handpiece). The handle can be elongate such that it can be grasped and manipulated along the same axis as the tip for insertion into the vaginal region. The handle can be adapted to include a quick release coupling for the tip at the distal end (eg, electrical coupling, coolant input line coupling, coolant output line coupling, sensor coupling, etc.). The proximal end of the handle can include a cord, cable or other connector for connection to the controller and/or power source. In some variations, the handle is configured for grasping by both hands (eg, two hands). The handle can also be configured such that it does not include one of the controls (switches, buttons, etc.) to initiate delivery of RF energy; rather, the delivery of RF energy can be by a foot switch or Other hands-free switches are delivered. This enhances the ease of grasping the applicator even when it is rotated and repositioned to reach the target tissue in the body.

該系統亦可經組態以使得冷卻劑在距患者之一實質距離處排放(例如，遠離手柄，在軟線/電纜之末端處)。在某些變化形式中，冷卻劑係連接至用於再循環或清理之一再循環器；在其他變化形式中，冷卻器在外部排放。 The system can also be configured such that the coolant is discharged at a substantial distance from one of the patients (eg, away from the handle, at the end of the cord/cable). In some variations, the coolant is connected to one of the recyclers for recycling or cleaning; in other variations, the cooler is discharged externally.

能量遞送元件可組態為一射頻、微波或超聲波遞送元件。某些特定實施例包括電容耦合之RF電極，其可藉由單極或雙極。基於單極RF電極之實施例可包含一導電墊以充當一返回電極。基於雙極RF之實施例可包括一對或一對以上電極。該等電極可進一步包含基於局部溫度來提供回饋控制之熱感測器，且可進一步包含識別治療尖端類型或將電極之組態參數傳送至手持件或傳送至較大電子系統之EEROM晶片。 The energy delivery element can be configured as a radio frequency, microwave or ultrasonic delivery element. Some specific embodiments include capacitively coupled RF electrodes that may be monopolar or bipolar. Embodiments based on a monopolar RF electrode can include a conductive pad to act as a return electrode. Embodiments based on bipolar RF can include one or more pairs of electrodes. The electrodes can further include a thermal sensor that provides feedback control based on local temperature, and can further include an EEROM wafer that identifies the type of treatment tip or transmits configuration parameters of the electrode to the handpiece or to a larger electronic system.

能量遞送元件及治療尖端亦可經調適以當尖端與一上皮接觸位點之間出現接觸及電容耦合時最佳化與生殖上皮表面之接觸。最佳接觸可指最佳化能量至目標組織中之遞送以使得其跨越接觸位點之表面廣泛均勻之一接觸，較佳沿接觸位點之邊緣無顯著畸變。能量之非均勻遞送不會很好地服務於重塑過程，且此外可產生破壞黏膜上皮之風險。 此等適應性組態可包括能量遞送元件之一側安裝組態，能量遞送元件之面相對於治療尖端之線性軸線大致平行。其他適應性組態可包括尖端之最接近於遠端部分之一變窄之 中間區段。此組態可允許尖端之遠端部分處之能量遞送元件自其周圍支撐結構向外或向前凸出，從而允許能量遞送元件與黏膜上皮之間的接觸更準確、謹慎且可見，且接觸壓力之位準由醫師更好地控制。 The energy delivery element and the treatment tip can also be adapted to optimize contact with the reproductive epithelial surface when contact and capacitive coupling occurs between the tip and an epithelial contact site. Optimal contact may refer to optimizing the delivery of energy into the target tissue such that it is widely and uniformly contacted across the surface of the contact site, preferably without significant distortion along the edges of the contact site. Non-uniform delivery of energy does not serve the remodeling process well, and in addition creates the risk of damaging the mucosal epithelium. Such adaptive configurations may include one side mounting configuration of the energy delivery elements, the faces of the energy delivery elements being substantially parallel with respect to the linear axis of the treatment tip. Other adaptive configurations may include narrowing one of the tips closest to the distal end portion Middle section. This configuration may allow the energy delivery element at the distal portion of the tip to project outwardly or forwardly from its surrounding support structure, thereby allowing the contact between the energy delivery element and the mucosal epithelium to be more accurate, discreet and visible, and the contact pressure The level is better controlled by the physician.

能量遞送元件之尺寸及組態可經調適以最佳化(特定而言)與***壁之接觸。能量遞送元件之寬度介於0.75cm與1.25cm之間。此一寬度足以以充分扁平且平行而使得跨越能量遞送元件之面之接觸品質大致相等之一方式嚙合***之彎曲壁，而不存在增加之壓力、較緊密之接觸或沿元件之邊緣之畸變。此一緊密接觸允許能量至下伏目標組織之一均勻遞送。在某些實施例中，能量遞送元件之面在元件之寬度內係徑向彎曲(相對於尖端之縱向軸線)以便形成高達30度之一弧。此曲率亦經調適以達成與***壁之平行接觸。根據本發明之實施例，具有約1cm寬度之一元件需要約10個接觸位點來徑向治療***內部之一300度弧，因此一30度弧提供抵靠***壁之彎曲之一良好配合且從而提供能量至目標組織中之一均勻遞送。 The size and configuration of the energy delivery element can be adapted to optimize (particularly) contact with the vaginal wall. The width of the energy delivery element is between 0.75 cm and 1.25 cm. This width is sufficient to engage the curved wall of the vagina in a manner that is sufficiently flat and parallel such that the quality of contact across the faces of the energy delivery elements is substantially equal, without the added pressure, tighter contact, or distortion along the edges of the element. This close contact allows energy to be delivered evenly to one of the underlying target tissues. In certain embodiments, the face of the energy delivery element is radially curved (relative to the longitudinal axis of the tip) within the width of the element to form an arc of up to 30 degrees. This curvature is also adjusted to achieve parallel contact with the vaginal wall. According to an embodiment of the invention, one of the elements having a width of about 1 cm requires about 10 contact sites to radially treat a 300 degree arc of the interior of the vagina, such that a 30 degree arc provides a good fit against one of the curvatures of the vaginal wall and Thereby providing energy to one of the target tissues for uniform delivery.

在典型實施例中，能量遞送元件之長度在長度上係約1cm至約3cm，在其他實施例中其可長達約4cm。此係經良好調適以治療***之下部方位之一長度，其中藉助該方法之治療包含在自***口向內延伸至一位置之一區中接觸***上皮，該位置係自***口向內約3cm至4cm。在本發明之某些實施例中，可以緊在***口內部之一單列平行接觸位點來實踐該方法。在其他實施例中，該方法可包括更深的 列，或與一初始列重疊之列，同時保持該等接觸位點在***之下部部分內。 In a typical embodiment, the length of the energy delivery element is from about 1 cm to about 3 cm in length, and in other embodiments it can be up to about 4 cm. This is well adapted to treat one of the lengths of the lower vagina orientation, wherein the treatment by the method comprises contacting the vaginal epithelium in a region extending inwardly from the vaginal opening to a location that is about 3 cm inward from the vaginal opening. Up to 4cm. In certain embodiments of the invention, the method can be practiced in a single column of parallel contact sites within the vaginal opening. In other embodiments, the method can include deeper Column, or a column that overlaps an initial column while maintaining the contact sites within the lower portion of the vagina.

一般而言，使裝置之能量遞送尖端冷卻。該尖端可在內部冷卻；舉例而言，可使該尖端內之一外殼(腔)冷卻以使施加器尖端冷卻。可藉由在外殼內應用一冷卻劑(例如，冷凍劑)來執行冷卻。舉例而言，可藉由自外殼內之一或多個噴嘴對著能量遞送表面之背面大小(內部側)噴灑一冷凍劑來使外殼冷卻。可最佳化所噴灑冷卻劑之型樣。期望以一高度可控制之方式完全且快速地冷却施加器。控制施加器尖端之溫度允許控制所施加之能量，乃因亦可調節組織溫度。快速冷卻係較佳，以便可高效且迅速地使用裝置。 然而，節約冷卻劑且控制冷卻劑之路徑亦係有益的，以便允許最高效地使用手持式施加器。因此，本文中闡述經組態以平衡冷卻劑之節約與施加器之快速且徹底之冷卻之裝置。舉例而言，該等裝置可經組態而具有複數個噴嘴，該複數個噴嘴具有覆蓋施加器表面(例如，能量遞送表面)之一個側之大部分之一噴灑型樣。可使噴嘴之數目最小化，同時使內部尖端空間內之噴灑型樣之分佈最大化。另外，施加器尖端及手柄區可包括一冷卻劑遞送通道及一冷卻劑返回通道，其包括一或多個密封及快速連接/快速釋放連接器。該手持區亦可包括與尖端冷卻劑遞送通道及冷卻劑返回通道配對之一或多個冷卻劑遞送通道及冷卻劑返回通道。冷卻劑返回通路可在近端延伸穿過裝置且可排放至遠離患者之位於近端之一釋放位點。舉例而言，冷卻劑返回 通道可延伸穿過施加器之近端處之電纜或連接器以在近端排放。在某些變化形式中，冷卻劑返回通道與用於捕獲冷卻劑之一冷卻劑再循環器耦合。該冷卻劑再循環器可經組態以收集冷卻劑以供稍後再使用及/或清理，或其可包括冷卻劑再循環組件(例如，壓縮機等)。 In general, the energy delivery tip of the device is cooled. The tip can be internally cooled; for example, one of the housings (cavities) within the tip can be cooled to cool the applicator tip. Cooling can be performed by applying a coolant (e.g., a cryogen) within the outer casing. For example, the outer casing can be cooled by spraying a cryogen against the backside size (internal side) of the energy delivery surface from one or more nozzles within the outer casing. The type of sprayed coolant can be optimized. It is desirable to completely and quickly cool the applicator in a highly controllable manner. Controlling the temperature of the applicator tip allows control of the applied energy, as the tissue temperature can also be adjusted. Rapid cooling is preferred so that the device can be used efficiently and quickly. However, it is also beneficial to save coolant and control the path of the coolant in order to allow the most efficient use of the hand-held applicator. Accordingly, devices configured to balance the savings of coolant with rapid and thorough cooling of the applicator are set forth herein. For example, the devices can be configured with a plurality of nozzles having a spray pattern covering a majority of one of the sides of the applicator surface (eg, the energy delivery surface). The number of nozzles can be minimized while maximizing the distribution of spray patterns within the internal tip space. Additionally, the applicator tip and handle region can include a coolant delivery channel and a coolant return channel that includes one or more sealing and quick connect/quick release connectors. The hand held area can also include one or more coolant delivery channels and coolant return channels that are paired with the tip coolant delivery channel and the coolant return channel. The coolant return passage may extend proximally through the device and may be vented to a release site at one of the proximal ends away from the patient. For example, coolant return The channel can extend through a cable or connector at the proximal end of the applicator to drain at the proximal end. In some variations, the coolant return passage is coupled to a coolant recycler for capturing a coolant. The coolant recirculator can be configured to collect coolant for later reuse and/or cleaning, or it can include a coolant recirculation assembly (eg, a compressor, etc.).

手柄及尖端(施加器)亦可包括一或多個燈。該等燈(例如，指示器等)可有助於引導裝置之操作，包括尖端之附接、裝置之對準、尖端與手柄之對準等。舉例而言，在某些變化形式中，手柄包括環繞裝置之近端或遠端之一燈，其可指示手柄之定向。在某些變化形式中，該等指示器燈可指示尖端固定至手柄及/或尖端之狀態(經冷卻且準備使用等)。手柄可包括用於操作裝置以自能量遞送元件施加能量之一或多個控制，諸如一按鈕或開關。 The handle and tip (applicator) may also include one or more lamps. Such lights (e.g., indicators, etc.) can aid in the operation of the guiding device, including attachment of the tip, alignment of the device, alignment of the tip with the handle, and the like. For example, in some variations, the handle includes a light that surrounds the proximal or distal end of the device, which can indicate the orientation of the handle. In some variations, the indicator lights may indicate the state in which the tip is secured to the handle and/or the tip (cooled and ready for use, etc.). The handle can include one or more controls for operating the device to apply energy from the energy delivery element, such as a button or switch.

如所述，尖端可經組態以快速連接及/或替換於手柄上。因此，尖端與手柄區可係模塊化的。在某些變化形式中，尖端與手柄係整體地(例如，永久性地)連接。在其他變化形式中，可在程序之間替換尖端，而再使用同一手柄。因此，尖端與手柄可經調適以達成快速且準確之連接。因此，尖端可包括用於連接至手柄上之一互補連接器以給能量遞送元件供電之一電連接器。尖端及手柄亦可包括用於連接冷卻劑遞送線路及返回線路之密封連接器。該等連接器可係搭扣配合(例如，摩擦配合)，其可牢固地附接及稍後移除。尖端可用鍵連接至手柄，以使得其僅可以恰當定向或組態附接。在某些變化形式中，該裝置可包括 一指示器，其指示尖端何時恰當附接(例如，使得冷卻劑線路被密封等)。 As noted, the tip can be configured to quickly connect and/or replace on the handle. Therefore, the tip and handle areas can be modular. In some variations, the tip is integrally (eg, permanently) coupled to the handle. In other variations, the tip can be replaced between programs and the same handle can be used. Thus, the tip and handle can be adapted to achieve a fast and accurate connection. Thus, the tip can include one of the electrical connectors for connecting to one of the complementary connectors on the handle to power the energy delivery element. The tip and handle may also include a sealed connector for connecting the coolant delivery line to the return line. The connectors can be snap fit (eg, a friction fit) that can be securely attached and later removed. The tip can be attached to the handle with a key so that it can only be properly oriented or configured for attachment. In some variations, the device can include An indicator that indicates when the tip is properly attached (eg, such that the coolant line is sealed, etc.).

亦闡述用於重塑女性生殖器之一目標組織內之一治療組織區之方法。該目標組織緊位於生殖組織之黏膜上皮下方，且包括固有層、包括細胞外空間中之膠原之一結締組織及包括平滑肌之肌肉。本發明之實施例之目標區不包括較深組織，諸如盆內筋膜。 A method for reshaping a treatment tissue area within one of the target tissues of the female genitalia is also described. The target tissue is located immediately below the mucosal epithelium of the reproductive tissue and includes a lamina propria, including connective tissue of collagen in the extracellular space and muscles including smooth muscle. The target zone of an embodiment of the invention does not include deeper tissue, such as an intra-pelvic fascia.

藉由本發明之實施例治療之女性生殖器之解剖學區域包括外陰及***以及***口(***之開口)。外陰包括自***口向外輻射至Hart氏線之組織，在Hart氏線處黏膜上皮為小***之外表面上之皮膚所代替。更具體地關於***，該方法之實施例包含治療***之下部部分，其係自***口延伸至一位置之一部分，該位置係自***口向內自約2cm至約4，在其他實施例中，該位置可向內延伸遠達約6cm。 關於***之內壁之圓周，一時鐘位置參考方案係有幫助的。尿道位置鄰近於***之前壁，***壁最接近尿道及尿道口之位置可被視為12點鐘。藉助此參考點，本發明之實施例之目標組織包括介於1點鐘與11點鐘之間的約300度弧。本發明之實施例不包括介於治療11點鐘與1點鐘之間的約60度弧，乃因此發明之實踐不針對尿道附近之組織。 The anatomical region of the female genital treated by embodiments of the present invention includes the vulva and vagina as well as the vaginal opening (opening of the vagina). The vulva includes tissue that radiates outward from the vaginal opening to the Hart's line, where the mucosal epithelium is replaced by skin on the outer surface of the labia minora. More specifically with regard to the vagina, embodiments of the method comprise treating a lower portion of the vagina extending from the vaginal opening to a portion of a position from about 2 cm to about 4 inward from the vaginal opening, in other embodiments This position can extend inward by as much as about 6 cm. Regarding the circumference of the inner wall of the vagina, a clock position reference scheme is helpful. The position of the urethra is adjacent to the anterior wall of the vagina, and the position of the vaginal wall closest to the urethra and urethra can be considered as 12 o'clock. With this reference point, the target organization of an embodiment of the present invention includes an approximately 300 degree arc between 1 o'clock and 11 o'clock. Embodiments of the present invention do not include an arc of about 60 degrees between 11 o'clock and 1 o'clock, so the practice of the invention is not directed to tissue near the urethra.

該方法之實施例包括藉助輻射能量加熱目標區，該輻射能量通常係射頻(RF)能量，但其他實施例可使用微波或超聲波能量。該方法包括使黏膜上皮與一治療尖端接觸，該治療尖端具有一能量遞送元件及一冷卻機構。藉由將能量 遞送至組織同時冷卻上皮表面，可形成一反向熱梯度。RF能量穿過經冷卻之上皮且進入下伏目標組織，且加熱該組織。 Embodiments of the method include heating the target zone with radiant energy, which is typically radio frequency (RF) energy, although other embodiments may use microwave or ultrasonic energy. The method includes contacting a mucosal epithelium with a treatment tip having an energy delivery element and a cooling mechanism. By putting energy Delivery to the tissue while cooling the epithelial surface creates a reverse thermal gradient. RF energy passes through the cooled epithelium and into the underlying target tissue and heats the tissue.

目標組織內的被加熱至一臨限位準(即，加熱至導致重塑之一治療溫度)之一組織區稱為一治療區。並非目標組織內的所有組織有必要達到此加熱臨限位準。在某些情形中，來自治療尖端之冷卻穿透至目標組織中，且在此情形下，經冷卻之組織之存在因將治療區移動至目標組織內較深處(舉例而言)或因限制治療區之體積而可對治療區具有一效應。 One of the tissue regions within the target tissue that is heated to a threshold level (i.e., heated to a treatment temperature that results in remodeling) is referred to as a treatment zone. It is not necessary for all organizations within the target organization to reach this level of heating threshold. In some cases, cooling from the treatment tip penetrates into the target tissue, and in this case, the presence of the cooled tissue moves the treatment zone deeper into the target tissue (for example) or because of limitations The volume of the treatment area can have an effect on the treatment area.

自治療尖端遞送之能量可將目標組織加熱至高達約80℃之一溫度。在某些實施例中，治療溫度範圍可介於約45℃與約80℃之間。在其他實施例中，治療溫度範圍可介於約50℃與約75℃之間。在另外其他實施例中，治療溫度範圍可介於約55℃與約70℃之間。加熱在一治療程序期間可經受回饋控制，以便將溫度保持於一預定溫度範圍內。可藉由一或多個感測器(包括熱感測器(例如，測溫電阻器))及阻抗監視器來提供回饋。治療尖端可使上皮冷卻至介於約0℃與約10℃之間的一溫度。相應地，一反向熱梯度可表示黏膜上皮處之介於約0℃與約10℃之間的一低溫度和目標組織中之介於45℃與約80℃之間的一高溫度。在一典型程序期間，根據本發明之實施例，任一加熱週期伴隨有冷卻；然而，冷卻亦可在加熱之前，及在加熱之後。 The energy delivered from the therapeutic tip can heat the target tissue to a temperature of up to about 80 °C. In certain embodiments, the therapeutic temperature range can be between about 45 °C and about 80 °C. In other embodiments, the therapeutic temperature range can be between about 50 °C and about 75 °C. In still other embodiments, the therapeutic temperature range can be between about 55 °C and about 70 °C. Heating can be subjected to feedback control during a treatment procedure to maintain the temperature within a predetermined temperature range. Feedback can be provided by one or more sensors, including thermal sensors (eg, temperature measuring resistors) and impedance monitors. The treatment tip cools the epithelium to a temperature between about 0 °C and about 10 °C. Accordingly, a reverse thermal gradient can represent a low temperature between about 0 ° C and about 10 ° C at the mucosal epithelium and a high temperature between 45 ° C and about 80 ° C in the target tissue. During a typical procedure, according to an embodiment of the invention, any heating cycle is accompanied by cooling; however, cooling may also be prior to heating, and after heating.

治療方法包含使治療尖端與黏膜上皮上之一接觸位點接 觸。該接觸位點與治療尖端之治療表面之尺寸一致。在一單個治療之過程期間(舉例而言，將發生於對診所之一訪問期間)，通常可治療複數個接觸位點。在一程序期間，可多次接觸一單個接觸位點。黏膜接觸位點之相加總數包含一治療區域。可在一柵格上記錄包含多個接觸位點之此一區域。該方法可在多於一個場合下應用；患者可在可評估一先前治療之效應且重複一治療之一稍後日期回訪其醫師。單獨程序之治療區域可相同、不同或重疊。 The treatment consists of bringing the treatment tip to a contact site on the mucosal epithelium touch. The contact site is sized to the size of the treatment surface of the treatment tip. During a single treatment procedure (for example, during a visit to one of the clinics), a plurality of contact sites can typically be treated. A single contact site can be accessed multiple times during a procedure. The sum of the mucosal contact sites contains a treatment area. This region containing a plurality of contact sites can be recorded on a grid. The method can be applied in more than one application; the patient can return to his or her physician at a later date on which one of the effects of the previous treatment can be evaluated and one of the treatments repeated. The treatment areas of the separate procedures may be the same, different or overlapping.

根據本發明之實施例，重塑生殖組織可包括使目標組織中之富膠原區域內之膠原熱變性。由於本方法使上覆黏膜上皮冷卻，因此其不被加熱，且不受該方法實質影響。治療區內目標組織之重塑可大致在組織被加熱之時間期間發生。重塑亦可大致在加熱已發生之後發生，舉例而言，幾天或幾星期後。此重塑包含對加熱之應力之生物學康復回應，且此等回應可包括新膠原之沈積。不論藉助現存膠原之變性或藉助新膠原之稍後沈積，重塑對組織之效應通常係組織收縮或變緊中之一者。因此，本發明之實施例包含使***及***口變緊。***產兒對***及***口之效應係此等組織之一鬆弛。由於該方法包含使此等組織變緊，因此該方法具有一復原效應，在於其向著組織在經歷***產兒之前所具有之構型來重塑組織。 According to an embodiment of the invention, remodeling the reproductive tissue can include thermally denaturation of collagen within the collagen-rich region of the target tissue. Since the method cools the overlying mucous membrane epithelium, it is not heated and is not substantially affected by the method. Remodeling of the target tissue within the treatment zone can occur substantially during the time the tissue is heated. Remodeling can also occur roughly after heating has occurred, for example, days or weeks. This remodeling involves a biological rehabilitation response to the stress of heating, and such responses may include deposition of new collagen. Whether by the denaturation of existing collagen or by later deposition of new collagen, the effect of remodeling on tissue is usually one of tissue contraction or tightening. Accordingly, embodiments of the invention include tightening the vaginal and vaginal opening. The effect of vaginal delivery on the vagina and vaginal opening is one of these tissues. Since the method involves tightening such tissue, the method has a healing effect in that it reshapes the tissue toward the configuration that the tissue had before it experienced vaginal delivery.

舉例而言，本文中闡述用於重塑下伏於女性生殖組織之黏膜上皮下面的組織內之一治療區之設備。一設備可包括：一細長手柄，其經組態以握持於兩隻手內；及一治療 尖端，其經組態以可移除地耦合至該細長手柄。該尖端可包括：一軸，其包含一縱向軸線；一能量遞送元件，其具有一上皮接觸表面；及一內部冷卻室，其經組態以在內部使該能量遞送元件冷卻，其中該能量遞送元件包含經調適以允許在發射RF能量以加熱目標組織時使上皮冷卻之一熱傳導表面。 For example, an apparatus for reshaping one of the treatment zones underlying the mucosal epithelium underlying female reproductive tissue is set forth herein. An apparatus can include: an elongated handle configured to be held in both hands; and a treatment A tip configured to be removably coupled to the elongated handle. The tip can include a shaft including a longitudinal axis, an energy delivery element having an epithelial contact surface, and an internal cooling chamber configured to internally cool the energy delivery element, wherein the energy delivery element A heat transfer surface is provided that is adapted to allow the epithelium to cool while emitting RF energy to heat the target tissue.

如上所述，該能量遞送元件可經組態以大致平行於該軸之該縱向軸線。該能量遞送元件可經組態而具有約0.75cm至約1.25cm之一寬度，及/或可具有約1cm至約3cm之一長度。該能量遞送元件可係大致扁平的。 As described above, the energy delivery element can be configured to be substantially parallel to the longitudinal axis of the shaft. The energy delivery element can be configured to have a width of from about 0.75 cm to about 1.25 cm, and/or can have a length of from about 1 cm to about 3 cm. The energy delivery element can be substantially flat.

在某些變化形式中，該內部冷卻室包含經組態以在該能量遞送元件之一內部部分上噴灑冷卻流體之複數個冷卻劑噴嘴。舉例而言，該設備可具有三個冷卻劑噴嘴。該能量遞送元件可具有至少一個RF電極(例如，四個電極)。該設備亦可包括位於最接近於該能量遞送元件處之至少一個溫度感測器。舉例而言，該溫度感測器可係一測溫電阻器。 In some variations, the internal cooling chamber includes a plurality of coolant nozzles configured to spray a cooling fluid over an interior portion of the energy delivery element. For example, the device can have three coolant nozzles. The energy delivery element can have at least one RF electrode (eg, four electrodes). The apparatus can also include at least one temperature sensor located proximate to the energy delivery element. For example, the temperature sensor can be a temperature measuring resistor.

該設備亦可包括在近端自該細長手柄延伸之返回冷卻劑通路，其經組態而以通道方式引導已使用之冷卻劑離開一患者。 The apparatus can also include a return coolant passage extending from the elongated handle at a proximal end configured to channel the used coolant away from a patient.

在某些變化形式中，該設備包括將該手柄連接至整合式控制器之一扁平電纜。該電纜可包括一冷卻劑遞送通道及一冷卻劑返回通道、至少一個RF電力線路。 In some variations, the device includes a flat cable that connects the handle to one of the integrated controllers. The cable can include a coolant delivery passage and a coolant return passage, at least one RF power line.

該手柄可不包括控制RF能量之施加之一按鈕或開關。而是，RF能量之施加可由不用手之機構(例如，腳踏開關、 語音啟動等)控制或由一控制器自動控制，或諸如此類。 舉例而言，該手柄可經組態以在與組織之充分接觸已持續一預定時間週期之後自動激發。 The handle may not include a button or switch that controls the application of RF energy. Rather, the application of RF energy can be done by hands-free mechanisms (eg, foot switches, Voice start, etc.) control or automatically controlled by a controller, or the like. For example, the handle can be configured to automatically fire after sufficient contact with the tissue has continued for a predetermined period of time.

本文中亦闡述用於重塑下伏於女性生殖組織之黏膜上皮下面的組織內之一治療區之系統，該系統包含：一細長手柄，其經組態以握持於兩隻手內，其中該手柄沿一縱向方向延伸；一治療尖端，其經組態以可移除地耦合至該細長手柄(該尖端包含：複數個能量遞送元件，其等具有上皮接觸表面；及至少一個內部冷卻室，其經組態以在內部使該等能量遞送元件冷卻，其中該能量遞送元件包含經調適以允許在發射RF能量以加熱目標組織時使上皮冷卻之一熱傳導表面)；及一整合式控制器。該整合式控制器可包括：一外殼；該外殼內之一RF產生器；該外殼內之一冷卻子系統；及用於控制該治療尖端之操作且確定該治療尖端何時與一目標組織接觸之一控制器。 Also described herein is a system for reshaping a treatment area within a tissue beneath the mucosal epithelium of a female reproductive tissue, the system comprising: an elongated handle configured to be held in both hands, wherein The handle extends in a longitudinal direction; a treatment tip configured to be removably coupled to the elongated handle (the tip comprising: a plurality of energy delivery elements having an epithelial contact surface; and at least one internal cooling chamber) Having been configured to internally cool the energy delivery elements, wherein the energy delivery element comprises a heat transfer surface adapted to allow epithelial cooling when emitting RF energy to heat the target tissue; and an integrated controller . The integrated controller can include: a housing; an RF generator within the housing; a cooling subsystem within the housing; and means for controlling operation of the treatment tip and determining when the treatment tip is in contact with a target tissue A controller.

該系統亦可包括將該手柄連接至該整合式控制器之一扁平電纜，該電纜包括一冷卻劑遞送通道及一冷卻劑返回通道、至少一個RF電力線路。在某些變化形式中，該系統包括經組態以連接至該整合式控制器且觸發複數個能量驅動元件對RF能量之施加之一腳踏開關。 The system can also include a flat cable connecting the handle to the integrated controller, the cable including a coolant delivery passage and a coolant return passage, at least one RF power line. In some variations, the system includes a foot switch configured to connect to the integrated controller and trigger application of a plurality of energy-driven elements to RF energy.

該整合式控制器亦可包括經組態以顯示控制資訊之一顯示器。該顯示器可經組態以顯示複數個能量遞送元件之一地圖，其指示接觸狀態。 The integrated controller can also include a display configured to display control information. The display can be configured to display a map of one of a plurality of energy delivery elements indicating a state of contact.

在某些變化形式中，該整合式控制器係可攜式的。舉例 而言，該整合式系統之重量可小於50磅，及/或具有小於25英吋×15英吋×16英吋(例如，23英吋深，15英吋高，且16英吋寬)之一佔用面積。 In some variations, the integrated controller is portable. Example In any aspect, the integrated system can weigh less than 50 pounds and/or have less than 25 inches by 15 inches by 16 inches (eg, 23 inches deep, 15 inches high, and 16 inches wide). A occupied area.

本文中亦闡述在不確定來自欲治療之一組織之一電阻抗之情形下確定一RF能量裝置之一治療尖端之一能量遞送元件是否與該組織充分連通之方法。舉例而言，該方法可包括以下步驟：確定自從最後一次啟動治療尖端之能量遞送元件以來之時間；提取治療尖端上之一或多個位點之溫度；藉由將治療尖端上之一或多個位點該溫度與自從最後一次啟動治療尖端以來之時間之一臨限函數相比較而在不將RF能量施加至組織之情形下來確定能量遞送元件是否與組織接觸；及指示治療能量遞送元件是否與組織接觸。 Also described herein is a method of determining whether an energy delivery element of one of the treatment tips of an RF energy device is in sufficient communication with the tissue without determining an electrical impedance from one of the tissues to be treated. For example, the method can include the steps of: determining the time since the last initiation of the energy delivery element of the treatment tip; extracting the temperature of one or more sites on the treatment tip; by treating one or more of the treatment tips The site determines whether the energy delivery element is in contact with the tissue without applying RF energy to the tissue compared to one of the time functions since the last time the treatment tip was initiated; and indicating whether the therapeutic energy delivery element is Contact with the organization.

在某些變化形式中，將該治療尖端上之該一或多個位點之溫度與一臨限函數相比較之該步驟包含與自從最後一次啟動治療尖端之能量遞送元件以來自約30秒至約180秒具有一斜升溫度臨限值之一臨限函數相比較。舉例而言，該治療臨限值可在自從最後一次啟動治療尖端之能量遞送元件以來之一有限時間範圍之間(例如，介於約30秒與約180秒之間)自約18攝氏度斜升至恰好在體溫下之一溫度。在一個變化形式中，該治療臨限值在自從最後一次啟動治療尖端之能量遞送元件以來之一有限時間範圍之間自約18攝氏度斜升至約27攝氏度。 In some variations, the step of comparing the temperature of the one or more sites on the treatment tip to a threshold function includes from about 30 seconds from the last time the energy delivery element of the therapeutic tip was activated Approximately 180 seconds has a ramping temperature threshold compared to one of the threshold functions. For example, the treatment threshold can be ramped from about 18 degrees Celsius between a limited time range since the last activation of the therapeutic tip energy delivery element (eg, between about 30 seconds and about 180 seconds) To just one of the temperatures at body temperature. In one variation, the treatment threshold ramps from about 18 degrees Celsius to about 27 degrees Celsius between a limited time range since the last initiation of the therapeutic tip energy delivery element.

本文中亦闡述用於重塑下伏於女性生殖組織之黏膜上皮下面的一目標組織內之一治療區之方法。該等方法可包 括：使一施加器之一拋棄式治療尖端自該施加器中之一內部管腔冷卻，其中該拋棄式治療尖端包括一或多個無創傷能量遞送元件；使用該治療尖端來加熱目標組織；及重塑目標組織之治療區。 Also described herein is a method for remodeling a treatment area within a target tissue beneath the mucosal epithelium of a female reproductive tissue. These methods can be packaged Included that one of the applicator disposable treatment tips is cooled from an internal lumen of the applicator, wherein the disposable treatment tip includes one or more atraumatic energy delivery elements; the treatment tip is used to heat the target tissue; And remodeling the treatment area of the target organization.

該方法亦可包括基於在該一或多個能量遞送元件上或附近之治療尖端之之一部分之溫度及自從最後一次啟動治療尖端以來之時間來確認與組織及一或多個能量遞送元件之接觸。舉例而言，確認接觸之該步驟包含在不施加能量之情形下確認接觸。先前所闡述方法步驟中之任一者亦可包括在內或應用於此方法。 The method can also include confirming contact with the tissue and one or more energy delivery elements based on a temperature of a portion of the treatment tip on or near the one or more energy delivery elements and a time since the last actuation of the treatment tip . For example, the step of confirming the contact includes confirming the contact without applying energy. Any of the method steps previously described may also be included or applied to the method.

設備device

本發明之實施例包括一種用於藉由將熱量施加至下伏於表面黏膜上皮下面的一目標組織同時使該表面上皮本身冷卻來重塑女性生殖組織之設備及方法。該設備及方法可在先前技術之彼等設備及方法上構建，諸如Knowlton所闡述之彼等設備及方法(包括US 2004/0000316及背景技術中所引用之其他專利案，此等專利案全部以引用方式併入本文中)，但本發明之設備及方法中包括經組態及調適而用以女性生殖器治療位點、本設備所接觸之黏膜上皮及根據本發明之態樣重塑之下伏目標組織調適等細目的新穎特徵。圖1顯示一設備1，其包含一手持件2及一治療尖端10。手持件2經調適以由一操作者(諸如一醫師)握持，且可包括至一較大支援系統(未顯示)之連接，或在某些實施例中，其 可作為自足獨立裝置而可操作。圖1顯示該治療尖端之軸之連接器部分15、窄中間區段24及包括能量遞送元件30之遠端部分28。 Embodiments of the present invention include an apparatus and method for reshaping female reproductive tissue by applying heat to a target tissue underlying the surface mucosal epithelium while cooling the surface epithelium itself. The apparatus and method can be constructed on the devices and methods of the prior art, such as those described by Knowlton, including other patents cited in US 2004/0000316 and the prior art, all of which are The method and method of the present invention includes the configuration and adaptation of the female genital treatment site, the mucosal epithelium contacted by the device, and the remodeling according to the aspect of the present invention. A novel feature such as target organization adaptation. Figure 1 shows an apparatus 1 comprising a handpiece 2 and a treatment tip 10. Handpiece 2 is adapted to be held by an operator, such as a physician, and may include a connection to a larger support system (not shown) or, in some embodiments, It can be operated as a self-contained independent device. 1 shows the connector portion 15 of the shaft of the treatment tip, the narrow intermediate section 24, and the distal end portion 28 including the energy delivery element 30.

圖2至圖5提供該治療尖端之各種視圖。圖2提供自一透視近端至尖端之一曝露視圖，圖3係自一側視角之一曝露視圖，且圖4係針對能量遞送元件定向之一正視圖，其經曝露以便顯露直接在該能量遞送元件下方之噴嘴。圖5顯示相對於能量遞送元件之類型(即，射頻電極，其不同地為單極、一雙極對及多個雙極對)而變化之治療尖端之實施例。更詳細地繪示於圖2至圖5中之治療尖端10包括一外殼26、一連接器部分15及經由線31(圖3)接收輸入之一能量遞送元件30。該治療尖端作為整體設計為相對於其至基本手持件2之附接之一快速連接/斷開單元。治療尖端10至手持件2之連接係藉助治療尖端之連接器部分15。外殼26界定自連接器部分15向治療尖端之遠端28向前延伸之一內部空間29。能量遞送元件30係相對於尖端之線性軸線側安裝，其經組態以在尖端之遠端部分28上之一側上面向外。一側安裝或經安裝以便面向治療尖端之一側意指能量遞送元件30經組態以大約平行於軸20之線性軸線。 Figures 2 through 5 provide various views of the treatment tip. Figure 2 provides an exposed view from one of the see-through proximal ends to the tip, Figure 3 is an exposed view from one of the side views, and Figure 4 is a front view of the energy delivery element oriented to expose directly to the energy A nozzle below the delivery element. Figure 5 shows an embodiment of a treatment tip that varies with respect to the type of energy delivery element (i.e., the radio frequency electrode, which is differently monopolar, one bipolar pair, and multiple bipolar pairs). The treatment tip 10, illustrated in more detail in Figures 2 through 5, includes a housing 26, a connector portion 15 and an energy delivery element 30 that receives input via line 31 (Figure 3). The treatment tip as a whole is designed as a quick connect/disconnect unit relative to one of its attachments to the basic handpiece 2. The connection of the treatment tip 10 to the handpiece 2 is by means of a connector portion 15 of the treatment tip. The outer casing 26 defines an interior space 29 that extends forwardly from the connector portion 15 toward the distal end 28 of the treatment tip. The energy delivery element 30 is mounted relative to the linear axis side of the tip and is configured to be outwardly on one side of the distal end portion 28 of the tip. Mounting or mounting on one side to face one side of the treatment tip means that the energy delivery element 30 is configured to be approximately parallel to the linear axis of the shaft 20.

在連接器部分15與尖端之遠端部分28之間的是變窄之中間區段中間部分24，此在與能量遞送元件30所面向之側相同之側上變窄或變細(變窄可通常發生於中間區段24中，但實施例通常包括至少在與能量遞送元件相同之側上變窄)。能量遞送元件30之側安裝組態及尖端之錐形區段24 兩者皆經調適以最佳化能量遞送元件與女性生殖器之上皮表面之接觸，特定而言與***之上皮表面之接觸。女性生殖器之細節進一步闡述於下文中。出於闡述一側放置部22及軸之錐形區段21之優點之目的，考量***之管道狀態樣及藉助嚙合該管道之側之一儀器而進入至該管道中。一細長結構最適於進入***中，且為達成與***之側之一大致扁平或表面至表面平行接觸，一側安裝能量遞送單元係有利的。平行接觸帶來之一優點係接觸壓力跨越該接觸區域相等地分佈，其中無偏向接觸位點之任一側之壓力。在此一均勻受壓接觸發生之情形下，能量亦均勻地被引導至下伏目標組織。軸之窄中間區段24為尖端10提供一功能優點，在於其允許在尖端之遠端部分28處之能量遞送元件30自軸之本體向前凸出，此凸出允許操作設備之醫師達成與上皮之具有適當壓力之接觸，以使該接觸更離散，使該接觸扁平，且使該接觸更佳地可見。 Between the connector portion 15 and the distal end portion 28 of the tip is a narrowed intermediate section intermediate portion 24 which narrows or tapers on the same side as the side facing the energy delivery element 30 (narrowing Typically occurs in the intermediate section 24, but embodiments typically include narrowing at least on the same side as the energy delivery element). Side mounting configuration of the energy delivery element 30 and tapered section 24 of the tip Both are adapted to optimize contact of the energy delivery element with the surface of the female genital epithelium, in particular with the vaginal epithelial surface. The details of the female genitalia are further elaborated below. For the purpose of illustrating the advantages of the side placement portion 22 and the tapered section 21 of the shaft, the state of the conduit of the vagina is considered and entered into the conduit by means of an instrument that engages the side of the conduit. An elongated structure is most suitable for accessing the vagina, and in order to achieve a substantially flat or surface-to-surface contact with one of the sides of the vagina, it is advantageous to have an energy delivery unit mounted on one side. One advantage of parallel contact brings that the contact pressure is equally distributed across the contact area, with no bias on either side of the contact site. In the event that a uniformly pressurized contact occurs, energy is also uniformly directed to the underlying target tissue. The narrow intermediate section 24 of the shaft provides a functional advantage to the tip 10 in that it allows the energy delivery element 30 at the distal end portion 28 of the tip to project forward from the body of the shaft, which allows the physician of the operating device to achieve The epithelium has a suitably stressed contact to make the contact more discrete, flatten the contact, and make the contact more visible.

此初始實例中之治療尖端10之總長度(自連接器部分15之基體至遠端部分28之最前點)經設計以使得側安裝之能量遞送元件30到達由尖端治療之***之最內區。相應地，尖端之實施例可具有介於約2.75英吋與4.25英吋之間的一總長度。特定實施例具有介於約3英吋與約4英吋之間的一總長度。另外更多實施例具有介於約3.25英吋與約3.75英吋之間的一總長度。此總長度適於提供對輕輕展開之***之下部部分之治療尖端接近。 The total length of the treatment tip 10 in this initial example (from the base of the connector portion 15 to the foremost point of the distal portion 28) is designed such that the side mounted energy delivery element 30 reaches the innermost region of the vagina treated by the tip. Accordingly, embodiments of the tip can have a total length of between about 2.75 inches and 4.25 inches. Particular embodiments have a total length of between about 3 inches and about 4 inches. Still other embodiments have a total length of between about 3.25 inches and about 3.75 inches. This total length is adapted to provide a therapeutic tip access to the gently deployed lower portion of the vagina.

能量遞送元件30亦具有有利地經調適以達成與***壁之 適當扁平之接觸之尺寸。該元件之寬度(在典型實施例中為RF電極)在某些實施例中介於約0.7cm與約1.3cm之間。在其他實施例中，該寬度介於約0.8cm與約1.2cm之間。在另外其他實施例中，該寬度介於約0.9cm與約1.1cm之間。在某些實施例中，能量遞送元件30之長度介於約2cm與約3cm之間。在其他實施例中，該長度介於約2.25cm與約2.75cm之間。對該長度之限制係關於能夠在黏膜上皮上之特定位點處達成接觸、避免與在***更深處之其他位點(不期望達成接觸之處)接觸及通常在所期望之治療區域處離散地且有效地達成接觸之有利態樣。該治療方法通常包含在自***口往裏不深於約3.5cm之一點處治療***。如上文所闡述，對能量遞送元件之寬度之限制與能夠達成與一彎曲表面之內部態樣之一大致扁平接觸之期望有關。藉由限制接觸位點之寬度，最小化可沿長度方向邊緣發生之接觸之一增加之壓力或靠近度。 The energy delivery element 30 also has an advantageous adaptation to achieve the vaginal wall The size of the appropriate flat contact. The width of the element (RF electrode in the exemplary embodiment) is between about 0.7 cm and about 1.3 cm in some embodiments. In other embodiments, the width is between about 0.8 cm and about 1.2 cm. In still other embodiments, the width is between about 0.9 cm and about 1.1 cm. In certain embodiments, the length of the energy delivery element 30 is between about 2 cm and about 3 cm. In other embodiments, the length is between about 2.25 cm and about 2.75 cm. Limiting this length is about being able to reach contact at a particular site on the mucosal epithelium, avoiding contact with other sites deeper in the vagina (where no contact is desired), and generally discretely at the desired treatment area. And effectively achieve the favorable aspect of contact. The method of treatment typically involves treating the vagina at a point that is not deeper than about 3.5 cm from the vaginal opening. As set forth above, the limitation of the width of the energy delivery element is related to the desire to achieve substantially flat contact with one of the internal aspects of a curved surface. By limiting the width of the contact sites, the pressure or proximity of one of the contacts that can occur along the lengthwise edges is minimized.

在上文所繪示之實施例中，能量遞送元件一直具有一扁平組態。圖6顯示治療尖端10之另一實施例，其中能量遞送元件30採用一曲線形式。在其他實施例中，能量遞送元件包含一彎曲表面，因此其相對於線性軸線徑向包括一曲率，同時保持與該線性軸線平行，該形式表示一圓柱體之一弧。圖6A顯示一治療尖端實施例，其中能量遞送元件係扁平的，而圖6B中之實施例具有一彎曲表面，該彎曲相對於該尖端之線性軸線係徑向的。該曲率之弧可高達約30度。某些實施例可包括約30度之一曲率。30度之曲率適於 配合***壁之曲率。 In the embodiment illustrated above, the energy delivery element has always had a flat configuration. Figure 6 shows another embodiment of the treatment tip 10 in which the energy delivery element 30 takes the form of a curve. In other embodiments, the energy delivery element comprises a curved surface such that it includes a curvature radially with respect to the linear axis while remaining parallel to the linear axis, the form representing an arc of a cylinder. Figure 6A shows a treatment tip embodiment in which the energy delivery element is flat and the embodiment of Figure 6B has a curved surface that is radial with respect to the linear axis of the tip. The curvature of the arc can be as high as about 30 degrees. Some embodiments may include a curvature of about 30 degrees. 30 degree curvature suitable Fit the curvature of the vaginal wall.

相應地，治療尖端10及能量遞送元件30之各種組態及尺寸態樣對於重塑生殖組織之方法係有利的。此等特徵特定而言適於治療***壁，但亦適於治療***外部之女性生殖器之黏膜上皮表面。如上文所闡述，此等特徵包括(1)能量遞送元件相對於治療尖端及其軸之線性軸線之面向側之定向，(2)治療尖端自其近端至遠端之總長度，(3)尖端之窄部分24允許能量遞送元件自一背景結構向前凸出而非處於與周圍結構之鄰接平面中，(4)能量遞送元件之表面尺寸(特定而言寬度)，其等在一扁平能量遞送元件30之情形中允許與***壁之大致扁平接觸，及(5)在具有一彎曲能量遞送元件之實施例之情形中，能量遞送元件與***壁之間的一特別緊密配合係可達成。所列舉之所有此等特徵對能量遞送表面與黏膜上皮之間的一均勻分佈之接觸有貢獻，此均勻配合減小可傷害上皮之邊緣偏向接觸之可能性，且正面地促進能量跨越能量遞送元件接觸上皮且能量輻射穿過而進入下伏目標組織之位點之區域均勻分佈。跨越一表面區域之通量均勻性促進重塑回應之一有利均勻性、一致性及可預測性。此外且同等重要地，通量之小變化亦最小化對上皮或目標組織之損壞之發生，此可發生於能量通量之大變化範圍(excursion)包括(其等不可避免地包括)接收高速率能量通量之區域時。 Accordingly, the various configurations and dimensions of the treatment tip 10 and energy delivery element 30 are advantageous for methods of remodeling reproductive tissue. These features are particularly suitable for treating the vaginal wall, but are also suitable for treating the mucosal epithelial surface of the female genitalia outside the vagina. As set forth above, such features include (1) the orientation of the energy delivery element relative to the treatment axis and its axial axis, and (2) the total length of the treatment tip from its proximal end to the distal end, (3) The narrow portion 24 of the tip allows the energy delivery element to project forward from a background structure rather than in an abutting plane with the surrounding structure, (4) the surface dimension (specifically the width) of the energy delivery element, which is equal to a flat energy In the case of the delivery element 30, a substantially flat contact with the vaginal wall is permitted, and (5) in the case of an embodiment having a curved energy delivery element, a particularly tight fit between the energy delivery element and the vaginal wall is achievable. All of the features recited contribute to a uniform distribution of contact between the energy delivery surface and the mucosal epithelium, which reduces the likelihood of damage to the edge of the epithelium, and positively promotes energy across the energy delivery element. The area that contacts the epithelium and the energy radiation passes through into the site of the underlying target tissue is evenly distributed. Flux uniformity across a surface region promotes one of the remodeling responses to favor uniformity, consistency, and predictability. In addition and equally important, small changes in flux also minimize the occurrence of damage to the epithelium or target tissue, which can occur in a wide range of energy flux excursions including (which inevitably include) receiving high rates When the energy flux is in the area.

如圖2及圖3中所見，尖端之內部空間29容納一冷卻系統以使能量遞送元件冷卻，該冷卻系統包含用於將冷卻流體 52傳送至噴嘴56之一冷卻管腔54。該冷卻流體可包含一冷凍劑，諸如1,1,1,2-四氟乙烷(R 134A)，其在壓力下儲存於一儲存器(未顯示)中，且可經由一管腔54傳送至噴嘴56。 該等噴嘴係組態於遠端部分28或尖端10中之內部空間(內部冷卻室)29內、能量遞送元件30之內表面下方。在冷凍劑自該等噴嘴釋放時，其噴灑至該內部表面上且隨該冷凍劑經歷一液體至氣體轉變而使該元件冷卻。當與一上皮黏膜表面接觸時(在實踐本發明之方法實施例期間)，能量遞送元件之外部表面在發生此接觸後即刻使該上皮表面冷卻。此表面冷卻可防止熱量在該黏膜表面上堆積，由遞送元件遞送之能量穿過該黏膜表面且進入由本發明視為目標之下伏組織，該下伏組織隨後被加熱。下文中更詳細地闡述之圖10A至圖10B及圖12至圖14B圖解說明包括冷卻劑噴灑及冷卻劑之移除及/或再循環之冷卻系統。 As seen in Figures 2 and 3, the internal space 29 of the tip houses a cooling system for cooling the energy delivery element, the cooling system including for cooling the fluid 52 is delivered to one of the nozzles 56 to cool the lumen 54. The cooling fluid can comprise a cryogen, such as 1,1,1,2-tetrafluoroethane (R 134A), which is stored under pressure in a reservoir (not shown) and can be delivered via a lumen 54 To the nozzle 56. The nozzles are configured in the inner portion (internal cooling chamber) 29 in the distal portion 28 or tip 10 below the inner surface of the energy delivery element 30. As the cryogen is released from the nozzles, it is sprayed onto the interior surface and the component is allowed to cool as the cryogen undergoes a liquid to gas transition. Upon contact with an epithelial mucosal surface (during practicing the method embodiments of the present invention), the outer surface of the energy delivery element cools the epithelial surface upon the occurrence of such contact. This surface cooling prevents heat from building up on the mucosal surface, and the energy delivered by the delivery element passes through the mucosal surface and into the underlying tissue that is considered to be targeted by the present invention, which is then heated. Figures 10A-10B and 12-14B, illustrated in more detail below, illustrate a cooling system that includes coolant spray and removal and/or recirculation of coolant.

能量遞送元件30可係一RF電極、一微波發射器或一超聲波發射器中之任一者。將以某一詳細程度闡述包括一RF電極之實施例。在某些實施例中，該RF電極係一電容電極，其電容耦合至黏膜上皮。在不限制本發明之範疇之情形下，該RF電極可具有在約0.01mm至約1.0mm之範圍中之一厚度。 The energy delivery component 30 can be any of an RF electrode, a microwave emitter, or an ultrasonic transmitter. Embodiments including an RF electrode will be described in a certain level of detail. In some embodiments, the RF electrode is a capacitive electrode that is capacitively coupled to the mucosal epithelium. The RF electrode can have a thickness in the range of from about 0.01 mm to about 1.0 mm without limiting the scope of the invention.

RF電極30具有面向治療尖端內之內部空間29之一導電部分35及面向該尖端之外部之一電介質部分36。導電部分35可包含一金屬，例示性金屬包括銅、金、銀及鋁。電介質部分36可包含各種不同材料，包括(以舉例之方式)聚醯亞 胺、特氟綸(RTM)及諸如此類、氮化矽、聚矽烷、聚矽氮烷、聚醯亞胺、Kapton及其他聚合物、天線電介質及此項技術中眾所周知之其他電介質材料。其他例示性電介質材料包括聚合物，諸如聚酯、矽、藍寶石、金剛石、鋯增韌氧化鋁(ZTA)、氧化鋁及諸如此類。電介質部分36覆蓋導電部分35且在治療期間設置於導電部分35與患者之組織之間。在另一實施例中，RF電極30由一複合材料製成，包括但不限於鍍金銅、銅聚醯亞胺、矽/氮化矽及諸如此類。 在一個實施例中，導電部分35黏附至電介質部分36，電介質部分36可係具有(以舉例之方式而非限制)約0.001"之一厚度之一基板。此實施例類似於電子業界中商業上可購得之一標準撓性電路板材料。在此實施例中，電介質部分36與黏膜上皮接觸，且導電部分35與黏膜上皮分離。 The RF electrode 30 has a conductive portion 35 facing the interior space 29 within the treatment tip and a dielectric portion 36 facing the exterior of the tip. Conductive portion 35 can comprise a metal, and exemplary metals include copper, gold, silver, and aluminum. The dielectric portion 36 can comprise a variety of different materials, including, by way of example, poly Amines, Teflon (RTM) and the like, tantalum nitride, polydecane, polyazane, polyimine, Kapton and other polymers, antenna dielectrics, and other dielectric materials well known in the art. Other exemplary dielectric materials include polymers such as polyester, ruthenium, sapphire, diamond, zirconium toughened alumina (ZTA), alumina, and the like. The dielectric portion 36 covers the conductive portion 35 and is disposed between the conductive portion 35 and the tissue of the patient during treatment. In another embodiment, the RF electrode 30 is made of a composite material including, but not limited to, gold plated copper, copper polyimine, tantalum/niobium nitride, and the like. In one embodiment, the conductive portion 35 is adhered to the dielectric portion 36, and the dielectric portion 36 can have, by way of example and not limitation, one of the thicknesses of about 0.001". This embodiment is similar to the commercial industry in the electronics industry. One of the standard flexible circuit board materials is commercially available. In this embodiment, the dielectric portion 36 is in contact with the mucosal epithelium and the electrically conductive portion 35 is separated from the mucosal epithelium.

一般而言，RF電極30可係單極或雙極的。在單極模式中，RF電流自一返回電極流過身體組織，該返回電極可係施加至患者之身體之另一部分之一導電墊之形式。圖5顯示電極自一面向視角之各種實施例，舉例而言，圖5A顯示具有一單極對電極之一尖端，圖5B顯示一雙極對，且圖5C顯示具有多個雙極對之一尖端。另外，電極可在治療尖端內之任一合適位置處裝備有一整合式EEROM(電可擦除只讀記憶體，亦稱為EEPROM)可程式化記憶體晶片(未顯示)。此一晶片可將識別資訊或關於RF電極之操作狀態或組態參數之其他資訊提供至該系統，此等參數可包括(以舉例之方式)電極之類型及大小、已開動能量遞送元件之 次數及諸如此類。另外，可在一RF電極之每一角落處或以其他方式最接近於該電極提供測溫電阻器(熱感測器)38(顯示於圖4中)，以向系統提供關於其位置處之溫度之回饋。 In general, RF electrode 30 can be monopolar or bipolar. In unipolar mode, RF current flows from a return electrode through body tissue, which may be applied to one of the conductive pads of another portion of the patient's body. Figure 5 shows various embodiments of the electrode from a viewing angle. For example, Figure 5A shows one of the tips of a single pole pair, Figure 5B shows a pair of poles, and Figure 5C shows one of a plurality of pairs of poles. Cutting edge. Alternatively, the electrodes can be equipped with an integrated EEROM (Electrically Erasable Read Only Memory, also known as EEPROM) programmable memory chip (not shown) at any suitable location within the treatment tip. The wafer may provide identification information or other information regarding the operational status or configuration parameters of the RF electrode to the system, such parameters may include, by way of example, the type and size of the electrode, the activated energy delivery element The number of times and the like. Additionally, a temperature measuring resistor (thermal sensor) 38 (shown in Figure 4) may be provided at each corner of the RF electrode or otherwise closest to the electrode to provide the system with respect to its location. Feedback from temperature.

在某些實施例中，治療尖端作為整體設計為一次性拋棄式組件，而手持件2通常係一可再使用儀器。治療尖端10之一次性及拋棄式態樣係在一醫療環境中根據其在一單個程序中之指定使用、在一女性患者進行一程序之背景下、根據下文中進一步闡述之方法之實施例。相應地，治療尖端之構造及組件之整體在經歷無菌化程序後保持其完整性，且該尖端通常單個封裝於保護尖端之無菌完整性之一容器或一包裝中直至其被打開包裝且連接至手持件2以準備用於一治療程序時。治療尖端10之實施例係模塊化的，在於其具有一共同連接器部分12，但可在軸部分20及能量遞送元件30及冷卻機構組件(諸如流體52或噴嘴56)中具有變化。 In some embodiments, the treatment tip is designed as a disposable disposable assembly as a whole, while the handpiece 2 is typically a reusable instrument. The disposable and disposable form of the treatment tip 10 is an embodiment of a method according to the method described further below in a medical environment, according to its intended use in a single procedure, in the context of a procedure performed by a female patient. Accordingly, the entirety of the configuration and components of the treatment tip maintains its integrity after undergoing a sterilisation procedure, and the tip is typically individually packaged in a container or package that protects the sterility of the tip until it is unpacked and connected to The handpiece 2 is ready for use in a therapeutic procedure. The embodiment of the treatment tip 10 is modular in that it has a common connector portion 12, but can vary in the shaft portion 20 and the energy delivery element 30 and cooling mechanism assembly (such as fluid 52 or nozzle 56).

設備之電子支援系統Equipment electronic support system

設備1可包括於具有若干特徵之一較大電子系統中，該等特徵包括一電源，諸如向一RF電力產生器提供能量之一RF電源，且電力自彼處流至RF電極30。多工器可量測與每一RF電極30相關聯之熱感測器38處之電流、電壓及溫度。該多工器可由一控制器驅動，該控制器可係一數位或類比控制器，或具有軟體之一電腦。當控制器係一處理器(諸如一電腦之一微處理器)時，其可包括經由一系統匯流排耦合之一CPU。在該系統上，亦可存在一鍵盤、磁盤驅 動或其他非揮發性記憶體系統、一顯示器及其他周邊裝置。一程式記憶體及一資料記憶體亦可耦合至該匯流排。 Apparatus 1 may be included in a larger electronic system having a number of features, including a power source, such as an RF power source that provides energy to an RF power generator, and power flows from there to RF electrode 30. The multiplexer can measure the current, voltage, and temperature at the thermal sensor 38 associated with each RF electrode 30. The multiplexer can be driven by a controller that can be a digital or analog controller or a computer with software. When the controller is a processor (such as a microprocessor of a computer), it can include a CPU coupled via a system bus. On the system, there may also be a keyboard and a disk drive. Mobile or other non-volatile memory systems, a display and other peripheral devices. A program memory and a data memory can also be coupled to the bus.

一操作者介面包括操作者控制及一顯示器。該控制器可耦合至不同類型之成像系統，包括超聲波、熱感測器38及阻抗監視器39。使用電流及電壓來計算阻抗。可最初運行一診斷階段以確定治療活動之位準。此可藉由超聲波以及其他手段完成。既可在治療之前亦可在治療之後執行診斷。 An operator interface includes operator controls and a display. The controller can be coupled to different types of imaging systems, including ultrasound, thermal sensor 38, and impedance monitor 39. The current and voltage are used to calculate the impedance. A diagnostic phase can be initially run to determine the level of treatment activity. This can be done by ultrasound and other means. The diagnosis can be performed either before or after treatment.

熱感測器38量測遞送至所期望之治療位點之電壓及電流；此等感測器之輸出由一控制器用來控制RF電力之遞送，其亦可控制溫度及電力。可確定一操作者設定之電力及/或溫度位準以提供將不會被超過之操作限制。該控制器可在改變之條件下維持該設定位準。所遞送之RF能量之量可控制電力量。所遞送之電力之一曲線以及欲遞送之能量之一預設量可併入於該控制器中。回饋控制可基於對阻抗、溫度或其他指示符之監視，且發生於控制器處或RF產生器處(若其併入有一控制器)。對於阻抗量測而言，此通常可藉由供應少量非治療RF能量來達成。然後量測電壓及電流以確認電接觸。 Thermal sensor 38 measures the voltage and current delivered to the desired treatment site; the output of such sensors is used by a controller to control the delivery of RF power, which also controls temperature and power. An operator set power and/or temperature level can be determined to provide operational limits that will not be exceeded. The controller can maintain the set level under varying conditions. The amount of RF energy delivered can control the amount of power. One of the curves of the delivered power and a predetermined amount of energy to be delivered can be incorporated into the controller. Feedback control can be based on monitoring of impedance, temperature, or other indicators, and occurs at the controller or at the RF generator (if it incorporates a controller). For impedance measurements, this can usually be achieved by supplying a small amount of non-therapeutic RF energy. The voltage and current are then measured to confirm electrical contact.

電路、軟體及至控制器之回饋產生全過程控制且用於改變電力、工作循環、單極或雙極能量遞送、流速及壓力，且亦可藉由時間、溫度及/或阻抗來確定該過程何時完成。可根據在接觸外部表面34上之多個位點處監視之組織溫度以及藉由監視每一RF電極39處之阻抗至電流流動、指 示在該過程期間組織之電流攜載能力之改變來控制及變化此等過程變量。此外，一控制器可提供多工，監視電流連續性，且確定啟動哪一RF電極30。 Circuitry, software, and feedback to the controller produce full process control and are used to change power, duty cycle, unipolar or bipolar energy delivery, flow rate and pressure, and time, temperature and/or impedance can be used to determine when the process carry out. The tissue temperature monitored at a plurality of sites on the contact external surface 34 and by monitoring the impedance at each RF electrode 39 to the current flow, Changes in the current carrying capacity of the organization during the process are shown to control and vary these process variables. In addition, a controller can provide multiplexing, monitor current continuity, and determine which RF electrode 30 to activate.

熱感測器38可係測溫電阻器，其等具有隨溫度變化之一電阻。一類比放大器可係與測溫電阻器及變換器一同使用之一習用差分放大器電流。該類比放大器之輸出由一類比多工器順序連接至一類比數位轉換器之輸入。該放大器之輸出係一電壓，其表示各別所感測溫度。數位化放大器輸出電壓由類比數位轉換器供應至一微處理器，該微處理器計算組織之溫度或阻抗。在某些實施例中，該微處理器可係一6800型，然而，可使用任一合適微處理器或通用數位或類比電腦來計算阻抗或溫度。該微處理器順序接收並儲存阻抗及溫度之數位表示。由該微處理器接收之每一數位值對應於不同溫度及阻抗。 The thermal sensor 38 can be a temperature measuring resistor that has a resistance that varies with temperature. A class of analog amplifiers can be used with temperature-measuring resistors and converters to share a differential amplifier current. The output of the analog amplifier is sequentially connected by an analog multiplexer to the input of an analog converter. The output of the amplifier is a voltage that represents the temperature sensed by each. The digital amplifier output voltage is supplied by an analog digital converter to a microprocessor that calculates the temperature or impedance of the tissue. In some embodiments, the microprocessor can be a Model 6800, however, any suitable microprocessor or general purpose digital or analog computer can be used to calculate the impedance or temperature. The microprocessor sequentially receives and stores a digital representation of the impedance and temperature. Each digit value received by the microprocessor corresponds to a different temperature and impedance.

可在一顯示器上指示所計算之溫度及阻抗值。另一選擇為或除溫度或阻抗之數值指示外，所計算之阻抗或溫度值亦可由該微處理器與溫度及阻抗限制相比較。當該等值超過預定溫度或阻抗值時，可在該顯示器上給出一警告，且另外，可降低至其各別電極之RF能量遞送或將其多工至另一電極。來自該微處理器之一控制信號可減小RF產生器之電力位準，或去致能遞送至任一特定電極之電力。該控制器接收並儲存表示所發送之溫度及阻抗之數位值。所計算之表面溫度及阻抗可由該控制器轉發至顯示器。若期望，將***黏膜組織層之所計算表面溫度與一溫度限制相比較 且可將一警告信號發送至該顯示器。類似地，當溫度或阻抗值超過一預定位準時，可將一控制信號發送至該RF電源。 The calculated temperature and impedance values can be indicated on a display. Alternatively, or in addition to a numerical indication of temperature or impedance, the calculated impedance or temperature value can also be compared by the microprocessor to temperature and impedance limits. When the value exceeds a predetermined temperature or impedance value, a warning can be given on the display and, in addition, RF energy delivery to its respective electrode can be reduced or multiplexed to another electrode. Control signals from one of the microprocessors can reduce the power level of the RF generator or disable the power delivered to any particular electrode. The controller receives and stores a digital value indicative of the temperature and impedance being transmitted. The calculated surface temperature and impedance can be forwarded by the controller to the display. If desired, compare the calculated surface temperature of the vaginal mucosa tissue layer to a temperature limit A warning signal can be sent to the display. Similarly, a control signal can be sent to the RF power source when the temperature or impedance value exceeds a predetermined level.

方法method

本文中闡述藉由將熱量施加至下伏於表面黏膜上皮下面的一目標組織同時使該表面上皮本身冷卻來重塑女性生殖器之組織之非外科方法及裝置。通常，該等組織係已經歷過一或多次***生產且其組織已因生育而拉伸的婦女之組織。特定而言，目標組織(圖8)係結締組織層，諸如下伏於生殖組織之黏膜上皮100下面的固有層或黏膜下層102及肌肉104。具有一上皮表面之生殖組織(圖7)之特定特徵或區域包括外陰126及***122，及***口114(***之進口)，及內生殖器與外生殖器之間的一劃分。 Non-surgical methods and devices for reshaping the tissue of the female genitalia by applying heat to a target tissue underlying the surface mucosal epithelium while cooling the surface epithelium itself are set forth herein. Typically, such tissues have been subjected to one or more vaginal productions and tissues whose tissues have been stretched by birth. In particular, the target tissue (Fig. 8) is a layer of connective tissue, such as the lamina propria or submucosa 102 and muscles 104 beneath the mucosal epithelium 100 underlying the reproductive tissues. Specific features or areas of the reproductive tissue having an epithelial surface (Fig. 7) include the vulva 126 and vagina 122, and the vaginal opening 114 (the entrance to the vagina), and a division between the internal genitalia and the external genitalia.

根據此發明之實施例，目標組織之加熱包括將目標組織之溫度升高至高達80℃。溫度被升高至一治療位準，即，升高至導致重塑之一溫度(如本文中所闡述)。目標組織之達到該治療溫度達一充分時間之部分稱為目標組織內之治療區。在某些情形中，該治療溫度可僅高達45℃或高達80℃。該等治療方法之某些變化形式包括將目標組織加熱至高達80℃。目標組織可被加熱至介於約45℃與約80℃之間的一溫度。在其他實施例中，目標組織溫度可被加熱至介於約50℃與約75℃之間的一溫度。在另外其他實施例中，目標組織可被加熱至介於約55℃與約70℃之間的一溫度。 According to an embodiment of the invention, heating of the target tissue comprises raising the temperature of the target tissue up to 80 °C. The temperature is raised to a therapeutic level, i.e., raised to a temperature that causes remodeling (as set forth herein). The portion of the target tissue that reaches the therapeutic temperature for a sufficient period of time is referred to as the treatment zone within the target tissue. In some cases, the therapeutic temperature can be as high as 45 ° C or as high as 80 ° C. Some variations of these treatments include heating the target tissue up to 80 °C. The target tissue can be heated to a temperature between about 45 ° C and about 80 ° C. In other embodiments, the target tissue temperature can be heated to a temperature between about 50 °C and about 75 °C. In still other embodiments, the target tissue can be heated to a temperature between about 55 °C and about 70 °C.

***係一纖維肌性管道，襯有連接女性生殖系統之外部器官與內部器官之複層鱗片狀上皮。***在前面的膀胱與後面的直腸及肛門之間以約45度之一角度向上且向後傾斜延展。一成人女性之前壁為約7.5cm長且後壁為約9cm長。在長度上之差異係由於宮頸***穿過前壁之角度。關於***更特定而言，本發明之實施例包含重塑***之下部部分，該下部部分表示，該下部為緊接著自***口向內處之部分。因此，根據本發明之實施例，欲治療之***之部分係***口與一位置之間的一區，該位置位於自***口向內不深於約3cm至約4cm處。關於***之圓周方位，可給沿***壁之周圍之位置指派一時鐘位置(參見圖7中之參考時鐘刻度盤136)，使得最靠近尿道130之圓周點處於12點鐘。使用此定向，本發明之實施例包含在自約1點鐘至約11點鐘之300度圓周弧上治療並重塑***。 A vaginal fibromuscular tube lined with a stratified squamous epithelium that connects the external organs and internal organs of the female reproductive system. The vagina extends upward and rearwardly at an angle of about 45 degrees between the front bladder and the posterior rectum and anus. An adult female front wall is about 7.5 cm long and the back wall is about 9 cm long. The difference in length is due to the angle at which the cervix is inserted through the anterior wall. With respect to the vagina, more particularly, embodiments of the invention include remodeling the lower portion of the vagina, the lower portion indicating that the lower portion is immediately adjacent the portion from the vaginal opening. Thus, in accordance with an embodiment of the present invention, the portion of the vagina to be treated is a region between the vaginal opening and a position that is not deeper than about 3 cm to about 4 cm from the vaginal opening. Regarding the circumferential orientation of the vagina, a position along the circumference of the vaginal wall can be assigned a clock position (see reference clock dial 136 in Figure 7) such that the circumferential point closest to the urethra 130 is at 12 o'clock. Using this orientation, embodiments of the invention include treating and reshaping the vagina on a 30 degree circumferential arc from about 1 o'clock to about 11 o'clock.

***及***口外部之外陰組織之黏膜上皮包括小***或外陰之自***口向外延伸至Hart氏線之部分，Hart氏線為黏膜上皮與***皮膚接觸之邊界(圖7)。黏膜上皮與該皮膚雖然鄰接但在胚胎學及組織學上不同。女性生殖器之由上皮覆蓋之部分亦由前庭之界限大致界定，其自***之頂部處之處女膜向外或向下延伸，輻射地超出***口，包括小***之位於Hart氏線120內之部分。本發明之實施例之目標組織包括下伏於生殖器的這些黏膜上皮表面下面的結締組織，其等自上皮表面向下分別稱作固有層102及肌肉104(圖8)(參見(舉例而言)Netter,Atlas of Human Anatomy, 4th edition,Saunders,2006)。固有層包括填充結締組織之細胞類型之一混合，諸如纖維原細胞，且肌肉係一平滑肌層。膠原藉由細胞(諸如，纖維原細胞)分泌或沈積至此等組織中之細胞外空間中。此等所闡述之在上皮下方之目標組織層上覆更深之組織，包括盆內筋膜，通常不作為目標，且可不受本文中所闡述之系統影響。 The mucosal epithelium of the vaginal and vaginal opening outside the genital tissue, including the labia minora or vulva, extends outward from the vaginal opening to the Hart's line, and the Hart's line is the boundary between the mucosal epithelium and the labia skin (Figure 7). The mucosal epithelium is adjacent to the skin but differs in embryology and histology. The portion of the female genital covered by the epithelium is also generally defined by the boundaries of the vestibule, which extends outwardly or downwardly from the top of the vagina, radiating beyond the vaginal opening, including the portion of the labia minora located within the Hart's line 120. The target tissue of embodiments of the present invention includes connective tissue underlying the surface of these mucosal epithelium under the genitals, which are referred to as the lamina propria 102 and muscle 104 from the epithelial surface, respectively (Fig. 8) (see, for example) Netter, Atlas of Human Anatomy, 4th edition, Saunders, 2006). The lamina propria includes a mixture of one of the cell types that fill the connective tissue, such as fibroblasts, and a muscular line, a smooth muscle layer. Collagen is secreted or deposited by cells (such as fibroblasts) into the extracellular space in such tissues. These deeper tissues, including the pelvic fascia, described above in the target tissue layer below the epithelium are generally not targeted and may not be affected by the systems described herein.

下伏於黏膜上皮表面下面的結締組織之重塑並不實質地影響上皮本身。本發明之實施例所提供之方法及設備對於生殖組織係非侵入性及大致非燒蝕性。設備與生殖組織之間的嚙合之性質為使治療尖端與生殖組織之上皮表面接觸之性質。藉由此接觸，設備將熱量遞送至下伏組織，同時藉由冷卻表面上皮來防止其加熱。 Remodeling of connective tissue underlying the surface of the mucosal epithelium does not substantially affect the epithelium itself. The methods and apparatus provided by embodiments of the present invention are non-invasive and substantially non-ablative to reproductive tissue. The nature of the meshing between the device and the reproductive tissue is the property of contacting the therapeutic tip with the epithelial surface of the reproductive tissue. By this contact, the device delivers heat to the underlying tissue while preventing it from heating by cooling the surface epithelium.

在一特定實施例中，本發明提供一種用於藉由使用一射頻(RF)能量源30(參見圖1至圖5之能量遞送元件)穿過***或外陰黏膜上皮組織且到達為本發明之實施例之目標組織之各別下伏層來重塑外陰及***目標組織之方法及設備。其他實施例可利用其他形式之能量，諸如微波或超聲波。穿過黏膜上皮之阻抗低於穿過皮膚之阻抗，因此需要比治療皮膚而非黏膜上皮所需要之能量更少之能量來導致加熱。 In a particular embodiment, the present invention provides a method for accessing the vaginal or vulvar mucosal epithelial tissue by using a radio frequency (RF) energy source 30 (see the energy delivery elements of Figures 1 through 5) and reaching the present invention Methods and apparatus for reshaping vulvar and vaginal target tissue by respective underlying layers of the target tissue of the embodiment. Other embodiments may utilize other forms of energy, such as microwaves or ultrasound. The impedance through the mucosal epithelium is lower than the impedance through the skin, thus requiring less energy than the energy required to treat the skin rather than the mucosal epithelium to cause heating.

能量至下伏結締組織之施加在目標組織中形成熱量，且吾人理解該熱量具有使組織中之膠原變性或部分變性之即刻或近即刻效應，膠原之此變性係組織重塑中之一因素。在本發明之其他實施例中，吾人理解，在一治療程序期間 熱量至結締組織之施加產生新膠原或新生膠原藉助結締組織之細胞之一後續沈積，此係可在該程序之後的幾個星期或幾個月之過程期間發生之一生物學過程之一部分。 The application of energy to underlying connective tissue forms heat in the target tissue, and we understand that this heat has an immediate or near immediate effect that denatures or partially denatures collagen in the tissue, which is one of the factors in tissue remodeling. In other embodiments of the invention, we understand that during a treatment procedure The application of heat to connective tissue produces subsequent deposition of new collagen or nascent collagen by one of the cells of connective tissue, which may occur as part of one of the biological processes during the weeks or months following the procedure.

如本發明之實施例所提供，不論藉由組織中之膠原之變性抑或藉由新膠原在組織中之後續沈積，生殖組織之重塑皆產生生殖組織之一變緊，特定而言***及***口之變緊。加熱目標組織之結果可包括組織中之預存在膠原之一熔化或變性，此可減小或壓縮膠原所佔據之體積，其效應係使周圍組織變緊。加熱之一較長期生物學結果可包括一康復過程，在該過程中細胞產生且沈積至細胞外空間中之速率存在一增加。吾人理解，兩種類型之回應，預存在膠原之近即刻回應及膠原量之較長期增加，皆對目標組織之一總體變緊有所貢獻。 As provided by embodiments of the present invention, remodeling of the reproductive tissue produces one of the reproductive tissues, particularly by vaginal and vaginal, whether by the denaturation of collagen in the tissue or by subsequent deposition of new collagen in the tissue. The mouth is getting tight. The result of heating the target tissue can include melting or denaturation of one of the pre-existing collagen in the tissue, which can reduce or compress the volume occupied by the collagen, the effect of which is to tighten the surrounding tissue. One of the longer term biological results of heating can include a healing process in which there is an increase in the rate at which cells are produced and deposited into the extracellular space. I understand that the two types of responses, the immediate immediate response of collagen and the longer-term increase in collagen volume contribute to the overall tightening of one of the target tissues.

組織之變緊使得經重塑之生殖器呈現一復原形式，即，在生殖器因***生產而受到拉伸之前所具有之一構型。如此發明之實施例所實踐，生殖組織之重塑可被不同地理解為組織之收縮或變緊，此可適用於外陰、***及***口。 藉由本發明之實施例之實踐復原之生殖器(舉例而言，藉助經重塑***及***口之較高緊度)在***期間提供增加之壓力及摩擦，且相應地可為具有此種經重塑生殖器之一婦女及其性伴侶提供較高性滿意度。 The tightening of the tissue causes the remodeled genitalia to assume a form of restoration, i.e., one configuration prior to the genital being stretched by vaginal production. As practiced by the embodiments of the invention, remodeling of the reproductive tissue can be understood differently as contraction or tightening of the tissue, which can be applied to the vulva, vagina, and vaginal opening. The genital restored by the practice of the embodiments of the present invention (for example, by means of a higher compression of the remodeled vagina and vaginal opening) provides increased pressure and friction during sexual intercourse, and correspondingly may have such a weight One of the genital genitals and their sexual partners provide higher sexual satisfaction.

本發明之實施例提供一種用於形成利用一或多個RF電極30之一反向熱梯度以傳送在目標組織中表現為熱量之能量之方法及設備及一種用以使目標下伏層上方之上皮表面冷 卻之機構。使上皮表面冷卻之一目的係保護其免受將在不存在冷卻之情形下累積之潛在破壞性過度熱量效應。上皮表面因此係供熱量穿過以到達下伏層之一導管，但能量在上皮表面處不會表現出增加之溫度之形式。因此，上皮本身不會被該方法破壞或實質地修改。免受加熱之此種保護可自經冷卻身體之散熱態樣以及與經冷卻組織相關聯之組織阻抗之一增加兩者獲得。 Embodiments of the present invention provide a method and apparatus for forming an inverse thermal gradient using one or more RF electrodes 30 to deliver energy that is expressed as heat in a target tissue and one for overlying the target underlying layer Cold epithelial surface But the institution. One of the purposes of cooling the epithelial surface is to protect it from potentially damaging excessive heat effects that would accumulate in the absence of cooling. The epithelial surface is thus supplied with heat to reach one of the underlying layers of the catheter, but the energy does not exhibit an increased temperature at the epithelial surface. Therefore, the epithelium itself is not destroyed or substantially modified by this method. Such protection from heat can be obtained from both the heat sinking of the cooled body and the increase in one of the tissue impedances associated with the cooled tissue.

在某些實施例中，設備之冷卻機構包括經調適以容納傳送至噴嘴56之一冷卻流體之一管腔54，噴嘴56冷卻設備之治療尖端10之能量遞送元件30。該方法之實施例因此提供接觸一生殖上皮表面上之一接觸位點，該尖端具有使表面上皮冷卻且加熱下伏組織之兩種能力。如本發明之實施例所提供，冷卻流體使設備之治療尖端冷卻；經冷卻之治療尖端之表面又使治療尖端接觸之黏膜上皮之表面冷卻。如本發明之實施例所提供，上皮表面可冷卻至約0℃至約10℃之一溫度範圍。隨著來自尖端之能量穿過黏膜上皮表面，下伏軟組織可加熱至約45℃至約80℃之一溫度範圍。 因此，形成一反向熱梯度，其中在黏膜上皮處具有一較低溫度，且在下伏組織中具有一較高溫度。 In certain embodiments, the cooling mechanism of the apparatus includes an energy delivery element 30 adapted to receive a lumen 54 of cooling fluid delivered to one of the nozzles 56 that cools the treatment tip 10 of the apparatus. Embodiments of the method thus provide for contacting a contact site on a genital epithelial surface having the ability to cool the surface epithelium and heat the underlying tissue. As provided by embodiments of the present invention, the cooling fluid cools the treatment tip of the device; the surface of the cooled therapeutic tip in turn cools the surface of the mucosal epithelium where the treatment tip contacts. As provided by embodiments of the present invention, the epithelial surface can be cooled to a temperature range of from about 0 °C to about 10 °C. As the energy from the tip passes through the mucosal epithelial surface, the underlying soft tissue can be heated to a temperature range of from about 45 °C to about 80 °C. Thus, a reverse thermal gradient is formed with a lower temperature at the mucosal epithelium and a higher temperature in the underlying tissue.

在某些實施例中，該方法包括回饋控制機構以控制加熱，以使得溫度不超過一預定位準。如設備之實施例所提供，回饋由熱感測器或阻抗感測器提供給RF遞送。在其他實施例中，可藉由遞送一預定總量之能量來控制該方法。在某些實施例中，可藉由在一預定量時間內遞送一量之能 量來控制該方法。 In certain embodiments, the method includes a feedback control mechanism to control the heating such that the temperature does not exceed a predetermined level. Feedback is provided by the thermal sensor or impedance sensor to the RF delivery as provided by an embodiment of the device. In other embodiments, the method can be controlled by delivering a predetermined amount of energy. In some embodiments, an amount of energy can be delivered by a predetermined amount of time The amount is used to control the method.

更具體而言，在本發明之目標組織內，可界定一治療區，特定而言在該治療區處熱量聚集或熱量達到足以導致重塑之一臨限溫度。此一治療區中心定在上皮下方一特定深度處，且該治療區可具有一特定深度範圍，舉例而言，其可跨越固有層與肌肉之全範圍而廣泛分佈，或其可佔據一相對扁平區。在本發明之某些實施例中，允許冷卻進行至上皮表面下方之目標組織本身中，以形成一冷保護組織區。目標組織之一部分之冷卻可對治療區具有一效應，使得治療區之深度及範圍可相對於在不存在目標組織之一部分之此冷卻之情形下其將位於之處調整或移位。舉例而言，若冷卻穿透至目標組織中之一給定位準以形成一冷保護區，則可將治療區推至目標組織中之更深處。此外，較低溫度一般而言往往含有熱量之散播，因此將治療區聚集至一較窄深度範圍中。 More specifically, within the target tissue of the present invention, a treatment zone may be defined, in particular where heat build-up or heat at the treatment zone is sufficient to cause a threshold temperature of remodeling. The center of the treatment zone is centered at a specific depth below the epithelium, and the treatment zone can have a specific depth range, for example, it can be widely distributed across the full extent of the lamina propria and muscles, or it can occupy a relatively flat Area. In certain embodiments of the invention, cooling is allowed to proceed into the target tissue itself below the epithelial surface to form a cold protected tissue region. Cooling of a portion of the target tissue may have an effect on the treatment zone such that the depth and extent of the treatment zone may be adjusted or shifted relative to where the cooling would occur if there is no portion of the target tissue. For example, if cooling penetrates into one of the target tissues to position a stop to form a cold protection zone, the treatment zone can be pushed deeper into the target tissue. In addition, lower temperatures generally tend to involve the spread of heat, thus concentrating the treatment zone into a narrower range of depths.

在本發明之典型實施例中，該方法提供與熱量被遞送至下伏組織之時間一致之表面冷卻。在某些實施例中，除在加熱下伏組織之同時使表面冷卻外，該方法亦包括在施加熱量之前的一冷卻週期。在其他實施例中，該方法包括在施加熱量之後的一冷卻週期。在另外其他實施例中，該方法包括施加熱量之前及之後的冷卻兩者。 In an exemplary embodiment of the invention, the method provides surface cooling consistent with the time at which heat is delivered to the underlying tissue. In some embodiments, the method includes a cooling cycle prior to applying heat, in addition to cooling the surface while heating the underlying tissue. In other embodiments, the method includes a cooling cycle after application of heat. In still other embodiments, the method includes both cooling before and after applying heat.

如圖8中所示，設備之一治療尖端10接觸生殖上皮100上之一接觸位點102，且此接觸在上皮上形成對應於治療尖端之外形之輪廓內之表面區域之一位點。圖8顯示尖端之 遠端28，其具有面向黏膜上皮之能量遞送元件30(由點線顯示)。亦顯示，接觸位點102(藉由點線)下方係目標組織層，固有層104及肌肉106。在本發明之典型實施例中，該方法包括與上皮接觸，遞送能量，且然後將治療尖端移動至另一接觸位點，且在彼處遞送能量。一程序(諸如將在對一診所之一訪問期間發生)將通常包括接觸***內之上皮及/或接觸***外部之其他位點之一徑向序列。在同一程序期間，治療尖端可多次返回至同一接觸點。一展開***(其在此方法之實踐期間輕輕拉伸)之下部部分之圓周為約12cm。相應地，藉由寬度為約1cm之一治療尖端，一系列約10個接觸位點允許完成該圓周之介於1點鐘位置與11點鐘位置之間的一300度弧。此等尺寸考量為該治療之一實施例之基本原理的基礎，其中能量遞送元件之表面具有約30度之一曲率，每一接觸位點計及300度弧之約10%。 As shown in Figure 8, one of the treatment points 10 of the device contacts one of the contact sites 102 on the reproductive epithelium 100, and this contact forms a site on the epithelium that corresponds to a surface region within the contour of the shape of the treatment tip. Figure 8 shows the tip A distal end 28 having an energy delivery element 30 (shown by dotted lines) facing the mucosal epithelium. It is also shown that the contact site 102 (by the dotted line) is below the target tissue layer, the lamina propria 104 and the muscle 106. In an exemplary embodiment of the invention, the method includes contacting the epithelium, delivering energy, and then moving the treatment tip to another contact site and delivering energy there. A procedure, such as would occur during an interview with one of the clinics, will typically include a radial sequence that contacts one of the intravaginal epithelium and/or other sites that contact the exterior of the vagina. The treatment tip can be returned to the same contact point multiple times during the same procedure. The circumference of the lower portion of the unfolded vagina (which is gently stretched during the practice of this method) is about 12 cm. Accordingly, by treating the tip with a width of about 1 cm, a series of about 10 contact sites allows a 300 degree arc between the 1 o'clock position and the 11 o'clock position of the circumference to be completed. These dimensional considerations are the basis of the basic principles of one embodiment of the treatment wherein the surface of the energy delivery element has a curvature of about 30 degrees, and each contact site accounts for about 10% of the 300 degree arc.

圖9A係一***122之一示意性表示，其中***口124形成至***之入口。在一典型程序中，治療尖端將接觸下部***中之正好在***口內部之各個接觸位點。如圖9A中所示，已藉由治療尖端治療之一累積組接觸位點102，且其共同組成***上皮上之一治療區域。在該方法之某些實施例中，接觸一單個徑向列，如圖9A中所示。在其他實施例中，在一程序中可包括一或多個另外列，其進一步向***中延伸，長度使得治療區域保持在***之下部部分中。根據本發明之實施例，接觸位點可包括在***之外部但在 Hart氏線之界限內之區。在***之外部，與***接觸位點之內徑向組態特性相比，治療區域將擴展為一較扁平態樣。如該方法之實施例所進一步提供且顯示於圖9B中，可在一柵格115上記錄接觸位點，完成之表格因此係治療區域之一映射表示，可在於治療之後的某一時間點處對重塑進行評價期間對其進行參考。如所示，治療表格可含有相對於***上之圓周位置(如(舉例而言)藉由時鐘刻度盤方案提供)之參考點。 Figure 9A is a schematic representation of one of the vagina 122 with the vaginal opening 124 forming an entrance to the vagina. In a typical procedure, the treatment tip will contact various contact sites in the lower vagina just inside the vaginal opening. As shown in Figure 9A, the group contact sites 102 have been accumulated by one of the therapeutic tip treatments, and together constitute one of the treatment areas on the vaginal epithelium. In some embodiments of the method, a single radial column is contacted, as shown in Figure 9A. In other embodiments, one or more additional columns may be included in a procedure that further extend into the vagina such that the treatment region remains in the lower portion of the vagina. According to an embodiment of the invention, the contact site can be included outside the vagina but at The area within the boundaries of the Hart's line. Outside the vagina, the treatment area will expand to a more flattened condition than the radially configured characteristics within the vaginal contact site. As further provided by an embodiment of the method and shown in Figure 9B, the contact sites can be recorded on a grid 115, the completed table thus being a map representation of one of the treatment regions, which can be at a point in time after treatment Reference is made during the evaluation of remodeling. As shown, the treatment table can contain a reference point relative to the circumferential position on the vagina (as provided, for example, by a clock dial scheme).

如上文所總結，可在一診所訪問期間之一單個程序期間治療一給定治療區域。該方法進一步包括重複此等程序，通常在另一天，當可評價先前程序之效應時。根據此評價，可做出關於重新治療一特定先前治療之區域之判斷，或進行至治療其他區域。因此，如該方法之實施例所提供，後續訪問期間之一或多個程序可不同地包括治療同一治療區域，治療一完全不同之治療區域，或治療一重疊治療區域，其與先前區域部分相同且部分不同。 As summarized above, a given treatment area can be treated during a single procedure during a clinic visit. The method further includes repeating such procedures, typically on another day, when the effects of the prior procedure can be evaluated. Based on this evaluation, a determination can be made regarding re-treatment of a particular prior treatment area, or to treat other areas. Thus, as provided by embodiments of the method, one or more of the procedures during subsequent visits may differently include treating the same treatment area, treating a completely different treatment area, or treating an overlapping treatment area that is identical to the previous area portion And partly different.

如上所述，冷卻系統通常包括施加器尖端之一內部冷卻，以使得能量遞送元件在施加能量以治療並重塑組織期間(且在某些情形中在其之前及/或之後)冷卻。可使用任一適當內部冷卻系統，特定而言包括使用冷卻劑(諸如，一致冷劑)之彼等內部冷卻系統。在某些變化形式中，該冷卻可係電的(例如，經由Peltier效應或諸如此類)。因此，尖端區之冷卻系統可包括如上文在圖2及圖3中所圖解說明之一冷卻室。該冷卻室可包括一開放區，用於噴灑或施加 冷卻劑之一或多個噴嘴可自與能量遞送元件之外表面熱連續之一熱傳導內表面而跨越定位於該開放區中。可將冷卻劑施加至此內表面以使能量遞送元件冷卻。可以任一適當型樣將冷卻劑施加至此內表面。舉例而言，圖10A顯示係熱傳導之一能量遞送元件之一內表面1001之一個變化形式。 As noted above, the cooling system typically includes internal cooling of one of the applicator tips to cause the energy delivery element to cool during application of energy to treat and reshape the tissue (and in some cases before and/or after). Any suitable internal cooling system may be used, specifically including internal cooling systems that use a coolant, such as a co-coolant. In some variations, the cooling can be electrically charged (eg, via the Peltier effect or the like). Thus, the cooling system of the tip zone may include a cooling chamber as illustrated above in Figures 2 and 3. The cooling chamber may include an open area for spraying or applying One or more nozzles of the coolant may be positioned in the open region across one of the thermally conductive inner surfaces of the outer surface of the energy delivery element. A coolant may be applied to the inner surface to cool the energy delivery element. The coolant may be applied to the inner surface in any suitable pattern. For example, Figure 10A shows a variation of inner surface 1001 of one of the energy delivery elements that are thermally conductive.

在圖10A中，重疊圓圈1003指示藉由八個噴嘴施加至內表面1001之冷卻劑(如圖10B中所示)之噴灑型樣。在圖10B中，該等噴嘴與內表面1001相對地間隔開，且自冷卻室之相對表面1009發射一圓錐形噴灑型樣1005。 In FIG. 10A, overlapping circles 1003 indicate spray patterns of coolant (as shown in FIG. 10B) applied to inner surface 1001 by eight nozzles. In FIG. 10B, the nozzles are spaced apart from the inner surface 1001 and a conical spray pattern 1005 is emitted from the opposing surface 1009 of the cooling chamber.

圖11圖解說明如所闡述可用作一施加器裝置之一部分之一手柄的另一變化形式。在此變化形式中，手柄1101係細長的，且包括一抓握區1003。該手柄亦可包括一或多個控制1005，諸如一按鈕、滑尺、刻度盤或諸如此類。該控制可允許使用者將能量施加至能量遞送元件，施加冷卻劑，或兩者。該手柄亦可包括用於指示裝置(包括尖端)之狀態及/或定向之一或多個指示器。舉例而言，一指示器可指示尖端經附接/或未附接。一指示器可指示裝置缺乏冷卻劑。一指示器可指示裝置準備好了啟動。一指示器可指示尖端(例如，能量遞送元件)之溫度及/或裝置已作用之時間。可使用任一適當指示器。在某些變化形式中，該指示器包括一或多個燈(例如，LED等)、色彩(包括彩色等)、文字數字(例如，一顯示螢幕或監視器)或諸如此類。該手柄通常經組態以與尖端配對，如上所述。在某些變化形式 中，尖端以一快速或易於附接及拆卸之方式耦合至該手柄。因此，尖端及/或手柄可經組態以用於快速釋放及快速附接。 Figure 11 illustrates another variation of the handle that can be used as one of the portions of an applicator device as set forth. In this variation, the handle 1101 is elongate and includes a gripping area 1003. The handle may also include one or more controls 1005, such as a button, slider, dial, or the like. This control may allow the user to apply energy to the energy delivery element, apply a coolant, or both. The handle may also include one or more indicators for indicating the status and/or orientation of the device (including the tip). For example, an indicator can indicate that the tip is attached/not attached. An indicator can indicate that the device lacks coolant. An indicator can indicate that the device is ready to start. An indicator can indicate the temperature of the tip (eg, the energy delivery element) and/or the time the device has been active. Any suitable indicator can be used. In some variations, the indicator includes one or more lights (eg, LEDs, etc.), color (including color, etc.), alphanumeric (eg, a display screen or monitor), or the like. The handle is typically configured to mate with the tip as described above. In some variations The tip is coupled to the handle in a quick or easy to attach and detach manner. Thus, the tip and/or handle can be configured for quick release and quick attachment.

舉例而言，圖13圖解說明尖端1301與一手柄1303之間的附接區之一個變化形式。該附接區經調適以容易且快速地附接/拆卸。該尖端及手柄兩者經組態以連接電連接器(給能量遞送元件供電)，及一冷卻劑遞送線路以及冷卻劑返回線路。該冷卻劑遞送線路係穿過手柄及尖端之一通道，冷卻劑可穿過其遞送以用於在冷卻室內釋放，如上文所闡述。可給冷卻劑加壓，且因此連接器必須經調適以處置高壓力而不會洩漏。因此，該裝置可在尖端與手柄之間的界面處包括冗餘密封，如圖13中所示。舉例而言，高壓力密封可組態為兩個或多個(例如，三個)高壓力面密封。在此變化形式中，該等密封並非環形密封，其可減小分離尖端與手柄所必要之拉離力。在某些變化形式中，冷卻劑返回線路(或冷卻劑返回通道或通路)係一低壓力返回線路，可以通道方式引導冷卻劑穿過該低壓力返回線路。該冷卻劑返回線路可經組態以自裝置(包括尖端及手柄區)移除冷卻劑，以使得其不排放或釋放。在某些變化形式中，該冷卻劑返回線路不排放或釋放冷卻劑，但其自遠離患者及/或操作裝置之技師之一位置釋放冷卻劑。舉例而言，手柄可包括遠離患者沿來自手柄之一軟線或連接器在近端排放冷卻劑之一冷卻劑返回通道。 For example, Figure 13 illustrates a variation of the attachment area between the tip 1301 and a handle 1303. The attachment area is adapted for easy and quick attachment/disassembly. Both the tip and the handle are configured to connect an electrical connector (powering the energy delivery element), and a coolant delivery line and a coolant return line. The coolant delivery line is routed through one of the handle and the tip through which the coolant can be delivered for release within the cooling chamber, as set forth above. The coolant can be pressurized, and thus the connector must be adapted to handle high pressures without leakage. Thus, the device can include a redundant seal at the interface between the tip and the handle, as shown in FIG. For example, a high pressure seal can be configured as two or more (eg, three) high pressure face seals. In this variation, the seals are not annular seals that reduce the pull-off force necessary to separate the tip from the handle. In some variations, the coolant return line (or coolant return passage or passage) is a low pressure return line that directs coolant through the low pressure return line. The coolant return line can be configured to remove coolant from the device (including the tip and handle regions) such that it does not discharge or release. In some variations, the coolant return line does not vent or release coolant, but it releases coolant from a location remote from the patient and/or one of the technicians operating the device. For example, the handle can include a coolant return passage that is remote from the patient along one of the cords from the handle or a connector that discharges coolant at the proximal end.

附接手柄1301可容易地附接及/或自尖端1303拆卸。舉 例而言，附接區1313可經組態以便以複數個容易釋放接觸點密封，而非將需要更多力來分離之一單個密封或接觸點(諸如環形密封)該等密封可替代地經組態以僅需要較小力來釋放。藉由增加接觸/密封之數目及/或密封之表面區域，可使用一較低釋放/連接力來形成一充分穩定之連接。舉例而言，可增加該密封表面區域，此允許一充分密封。 The attachment handle 1301 can be easily attached and/or detached from the tip 1303. Lift For example, the attachment area 1313 can be configured to seal with a plurality of easily released contact points, rather than requiring more force to separate one of the individual seals or contact points (such as an annular seal). The configuration requires only a small force to release. By increasing the number of contacts/seals and/or the surface area of the seal, a lower release/joining force can be used to form a substantially stable connection. For example, the sealing surface area can be increased, which allows for a sufficient seal.

在某些變化形式中，收集及/或再循環冷卻劑。舉例而言，冷卻劑返回通路可連接至收集用過之冷卻劑之一冷卻劑返回儲存器。稍後可再循環或再使用此冷卻劑。在某些變化形式中，該系統包括用於再使用冷卻劑之一壓縮機或再循環器。 In some variations, the coolant is collected and/or recycled. For example, the coolant return passage can be connected to one of the collected coolant back to the coolant return reservoir. This coolant can be recycled or reused later. In some variations, the system includes a compressor or recirculator for reusing coolant.

圖12顯示穿過一裝置1201之一尖端之另一變化形式之一剖面，裝置1201包括一冷卻室1203，冷卻室1203具有用於跨越冷卻室1203施加冷卻劑且將冷卻劑施加至能量遞送組件1205之一內部表面上之複數個(三個)噴嘴。在此變化形式中，噴灑已經最佳化以使得能量遞送組件1205之內部表面之相對大區域將由較小冷卻噴嘴1207冷卻。舉例而言，在圖12中，該裝置包括三個負責冷卻能量遞送組件之大部分(幾乎全部)內部表面之噴嘴1027，如圖14A中所圖解說明。 Figure 12 shows a cross-section through another variation of one of the tips of a device 1201 that includes a cooling chamber 1203 having a means for applying coolant across the cooling chamber 1203 and applying coolant to the energy delivery assembly A plurality of (three) nozzles on one of the inner surfaces of 1205. In this variation, the spray has been optimized such that a relatively large area of the interior surface of the energy delivery assembly 1205 will be cooled by the smaller cooling nozzle 1207. For example, in Figure 12, the apparatus includes three nozzles 1027 that are responsible for cooling most (almost all) of the interior surface of the energy delivery assembly, as illustrated in Figure 14A.

圖14A及圖14B分別顯示僅具有三個用於在外殼內遞送冷卻劑之噴嘴1402之一裝置之噴灑型樣。在此變化形式中，噴嘴1402成角度以瞄準能量遞送組件之內部表面之縱向分離(但 重疊)之區，藉此使其冷卻。據信，圖14A及圖14B中所圖解說明之配置比圖10A及圖10B中所示之其中使用八個噴嘴來將冷卻劑施加至相同空間之組態更高效。儘管冷卻劑之重疊較小，但據信，在幾乎相同之時間內，能量遞送組件可如同在較大數目之噴嘴之情形下那樣有效地冷卻。圖14B及圖12(其圖解說明同一變化形式)中所示之噴嘴1207將冷卻劑施加至能量遞送組件之大部分熱傳導內表面。由於此內表面為熱傳導的，因此使內表面(甚至內表面之一部分)冷卻將導致使尖端之能量遞送組件之外表面冷卻，且藉此導致與此尖端接觸之組織之冷卻。 Figures 14A and 14B show spray patterns of only one of the three nozzles 1402 for delivering coolant within the housing, respectively. In this variation, the nozzle 1402 is angled to aim the longitudinal separation of the interior surface of the energy delivery assembly (but The area of overlap) is thereby cooled. It is believed that the configuration illustrated in Figures 14A and 14B is more efficient than the configuration shown in Figures 10A and 10B in which eight nozzles are used to apply coolant to the same space. Although the overlap of the coolants is small, it is believed that the energy delivery assembly can be effectively cooled as in the case of a larger number of nozzles in nearly the same amount of time. The nozzle 1207 shown in Figures 14B and 12 (which illustrates the same variation) applies coolant to a majority of the thermally conductive inner surface of the energy delivery assembly. Since this inner surface is thermally conductive, cooling the inner surface (and even a portion of the inner surface) will result in cooling of the outer surface of the energy delivery assembly of the tip, and thereby causing cooling of the tissue in contact with the tip.

系統system

一***重塑系統可包括一手柄、一拋棄式(或可再使用)治療尖端、一電源/供電源、複數個溫度感測器、一冷卻子系統及一控制器。在某些變化形式中，該控制器、供電源/電源及冷卻子系統可整合至手柄及尖端可耦合至之一單個單元中。此整個系統可經組態以便易於使用，包括可攜性及緊湊配置。 A vaginal remodeling system can include a handle, a disposable (or reusable) treatment tip, a power/supply source, a plurality of temperature sensors, a cooling subsystem, and a controller. In some variations, the controller, power supply/power supply, and cooling subsystem can be integrated into the handle and the tip can be coupled into a single unit. This entire system can be configured for ease of use, including portability and compact configuration.

舉例而言，在一個變化形式中，該系統可包括：一治療尖端(用於RF能量之遞送)、一冷卻劑源(例如，致冷劑)、一手持件(手柄)、將手柄及尖端連接至該冷卻劑源及/或電源及/或控制系統之一電纜、一電源(例如，RF產生器)及一控制器。視情形，該系統亦可包括一耦合流體、一返回墊、一單獨控制開關(例如，腳踏開關)。 For example, in one variation, the system can include: a treatment tip (for delivery of RF energy), a coolant source (eg, a cryogen), a handpiece (handle), a handle and a tip Connected to the coolant source and/or one of the power and/or control system cables, a power source (eg, an RF generator), and a controller. Optionally, the system can also include a coupling fluid, a return pad, and a separate control switch (eg, a foot switch).

如所述，在某些變化形式中，該控制器、電源(RF產生 器)及冷卻系統可全部整合至連接至(經由一或多個電纜)該手持件及治療尖端之一單個單元中。舉例而言，圖15A至圖15F圖解說明包括與電源整合之控制器及連接至手持件及尖端之冷卻劑之一系統之一個變化形式。 As mentioned, in some variations, the controller, power supply (RF generation And the cooling system can be fully integrated into a single unit that is connected (via one or more cables) to the handpiece and the treatment tip. For example, Figures 15A-15F illustrate a variation of a system including a controller integrated with a power source and a coolant coupled to the handpiece and the tip.

圖15A顯示該整合式系統之一正視圖，其中手柄經由一單個電纜連接至含有控制器、冷卻系統及RF電源之一底盤。為方便起見，該整合式控制器、冷卻系統及RF電源將稱作一整合式控制器，其包括可由控制器控制或調節之整合式冷卻系統及電源兩者。此實例中之系統1500包括手持件(手柄1505)及治療尖端1507經由一電纜1509附接至之一顯示器1501及一外殼1503。該電纜可包括供應及返回冷卻劑線路以及至RF能量供應及治療尖端上之任何感測器之一連接。 Figure 15A shows a front view of the integrated system with the handle connected to a chassis containing a controller, a cooling system, and an RF power source via a single cable. For convenience, the integrated controller, cooling system, and RF power source will be referred to as an integrated controller that includes both an integrated cooling system and a power source that can be controlled or regulated by the controller. System 1500 in this example includes a handpiece (handle 1505) and a treatment tip 1507 attached to one of display 1501 and a housing 1503 via a cable 1509. The cable can include a supply and return coolant line and a connection to any of the RF energy supply and any of the sensors on the treatment tip.

圖15B圖解說明裝置之背面，包括一冷卻劑可***至其中之一開口。在此實例中，冷卻劑係一冷卻劑罐1521，其可附接至該開口中且固定到位以向系統提供冷卻劑。圖15C至圖15F顯示外殼移除從而曝露支撐控制器(微處理器)、冷卻系統及RF電源之底盤之系統之背面透視圖及側透視圖。 Figure 15B illustrates the back side of the device including a coolant insertable into one of the openings. In this example, the coolant is a coolant tank 1521 that can be attached into the opening and secured in place to provide coolant to the system. 15C-15F show a rear perspective view and a side perspective view of a system in which the housing is removed to expose the chassis supporting the controller (microprocessor), cooling system, and RF power.

在此實例中，整合式冷卻劑包括可固定至外殼中之開口中之一罐1521。舉例而言，該冷卻劑可係一經加壓致冷劑(諸如R-134A或其他適當冷卻劑)罐。在此實例中，該冷卻劑罐可刻有一或多組螺紋以在整合式控制器中將其固定到位，但可使用用於冷卻劑之任一適當密封機構。冷卻劑之 位準可由控制器監視，且顯示器可包括指示罐或系統中剩餘冷卻劑之位準之一圖標(例如，參見圖20A至圖20C，下文更詳細闡述)。 In this example, the integrated coolant includes one of the cans 1521 that can be secured to the opening in the outer casing. For example, the coolant can be a pressurized refrigerant (such as R-134A or other suitable coolant) canister. In this example, the coolant tank can be engraved with one or more sets of threads to secure it in place in an integrated controller, but any suitable sealing mechanism for the coolant can be used. Coolant The level can be monitored by the controller, and the display can include an icon indicating the level of remaining coolant in the tank or system (see, for example, Figures 20A-20C, as explained in more detail below).

整合式系統之底盤之一個實例顯示於圖19A至圖19E中。該底盤支撐整合式控制器之組件，諸如用於控制系統之一微處理器(其可包括硬體、軟體及/或韌體)、任何輸出(例如，監視器、一或多個揚聲器等)、RF電源及冷卻子系統。可以允許整合式控制器之此等不同部分為「模組化」之一方式在外殼內在支撐底盤中對其進行分割。舉例而言，整合式控制器之整體或部分可為模組化的以允許其等容易地由新的或經刷新之組件換出。舉例而言，圖19A顯示全部組件皆移除之一底盤1902之一側視圖。移除外殼之側面板可曝露各種組件定位至其中之內部區或隔間。圖19B顯示底盤之一頂部件1904之一透視圖，其亦係可移除的，而圖19C及圖19D顯示底盤之前部1909及內部區1908之透視圖。圖19E顯示底盤之背部1910及底部件1912之一透視圖。 An example of a chassis for an integrated system is shown in Figures 19A-19E. The chassis supports components of an integrated controller, such as a microprocessor for a control system (which may include hardware, software, and/or firmware), any output (eg, a monitor, one or more speakers, etc.) , RF power and cooling subsystems. These different portions of the integrated controller may be allowed to be split in the support chassis within the housing in one of "modularization". For example, the integrated controller may be modular or integral to allow it to be easily swapped out by new or refreshed components. For example, Figure 19A shows a side view of one of the chassis 1902 with all of the components removed. Removing the side panels of the outer casing exposes the internal zones or compartments into which the various components are positioned. Figure 19B shows a perspective view of one of the top members 1904 of the chassis, which is also removable, while Figures 19C and 19D show perspective views of the front portion 1909 and the inner region 1908 of the chassis. Figure 19E shows a perspective view of the back 1910 and bottom member 1912 of the chassis.

底盤可包括允許各個區或組件容易地***及移除(拉出)之軌道或底座。外殼中之組件之總體配置可包括垂直及水平板或區，其可容易地接近。 The chassis may include a track or base that allows individual zones or components to be easily inserted and removed (pushed out). The overall configuration of the components in the housing can include vertical and horizontal panels or zones that are easily accessible.

在該實例中，圖15A至圖15F中所示之系統，其中顯示手柄及尖端接近前部附接至裝置之側。在某些變化形式中，手柄自一中心前部區附接至整合式控制器。此可允許手柄之最大到達程度，而不管裝置之使用者之定向(或用手習慣)如何。整合式控制器亦可包括用於手持件之一固 持件或支架。在某些變化形式中，控制器外殼可包括構建至外殼中或自外殼之任一(或兩個)側延伸之一支架外殼。 In this example, the system illustrated in Figures 15A-15F, wherein the display handle and tip are attached to the side of the device proximate the front. In some variations, the handle is attached to the integrated controller from a central front region. This allows for maximum reach of the handle, regardless of the orientation of the user of the device (or by hand). The integrated controller can also include one of the handpieces Hold or bracket. In some variations, the controller housing can include a bracket housing that is built into or extending from either (or both) sides of the housing.

系統且特定而言整合式控制器之總體重量及佔用面積可充分小，以使得裝置係可攜式的且可易於儲存，此對於在外科手術室或門診部之間移動可係重要的。舉例而言，圖16A至圖16C圖解說明包括一整合式控制器(整合控制器、RF產生器及冷卻系統)之一系統之一組例示性尺寸。在此實例中，整合式控制器小於約23英吋長(深)、15英吋高及16英吋寬。整個系統之重量可小於50磅。 The overall weight and footprint of the system and, in particular, the integrated controller can be sufficiently small to make the device portable and easy to store, which can be important for movement between surgical rooms or clinics. For example, Figures 16A-16C illustrate a set of exemplary dimensions of one of a system including an integrated controller (integrated controller, RF generator, and cooling system). In this example, the integrated controller is less than about 23 inches long (deep), 15 inches high, and 16 inches wide. The entire system can weigh less than 50 pounds.

該系統亦可包括用於控制裝置之一或多個控制。特定而言，該系統可包括(例如)與整合式控制器通信之用於自治療尖端遞送能量之一控制(例如，啟動控制)以及用於控制治療範圍之一或多個控制。 The system can also include one or more controls for the control device. In particular, the system can include, for example, one of a plurality of controls for self-therapeutic tip delivery energy (eg, activation control) in communication with the integrated controller and for controlling one or more of the treatment ranges.

在圖15A中所示的實例中，所示顯示器螢幕係一觸控螢幕，其允許使用者藉由觸摸該螢幕來選擇治療參數。如上所述，在某些變化形式中，該系統可包括一鍵盤、滑鼠、軌跡球或諸如此類。 In the example shown in Figure 15A, the display screen is shown as a touch screen that allows the user to select treatment parameters by touching the screen. As noted above, in some variations, the system can include a keyboard, mouse, trackball, or the like.

在某些變化形式中，藉由包括一按鈕將啟動控制包括於手持件(例如，手柄)上，如上文所論述之例示性手柄中所示。然而，包括不包括一按鈕(諸如，一啟動控制)之一治療手柄可係意外有利的。如上文所闡述，由於使用者可正在將能量施加至裝置以自相對於(通常傾向於)患者之各種定向進行治療，因此包括用於啟動之控制之一腳踏開關可係更方便的。因此，在某些變化形式中，該系統可包括一 無線或有線腳踏開關或與手持件分離之其他控制。在一個變化形式中，腳踏開關連接至整合式控制(例如，藉由自外殼延伸之一軟線或線)。 In some variations, the activation control is included on the handpiece (e.g., the handle) by including a button, as shown in the illustrative handle discussed above. However, including a treatment handle that does not include a button (such as a start control) can be surprisingly advantageous. As explained above, a foot switch including one of the controls for activation may be more convenient as the user may be applying energy to the device to treat from various orientations relative to (usually tend to) the patient. Thus, in some variations, the system can include a Wireless or wired foot switch or other control separate from the handpiece. In one variation, the foot switch is connected to an integrated control (eg, by a cord or wire extending from the housing).

如所述，手持件(手柄)通常藉由一電纜或軟線(包括用於冷卻劑、電力等之一遞送/返回)連接至整合式控制器。可針對撓性、支撐強度及長度最佳化手持件軟件之長度。電纜必須具有充分支撐性以允許冷卻劑之遞送及返回(除用於RF能量及/或任何感測器之電力線路外)而不會扭結，扭結可另外阻擋或阻止冷卻劑至治療尖端之遞送。然而，用於冷卻劑之具有充分強度之電纜可過粗或剛性過大，因此使得把握起來困難。已確定，其中並行配置有各種通道之一扁平電纜(如本文中所圖解說明)可准許充分撓性，以允許控制之簡易性，而不會犧牲強度。相比而言，一圓形電纜可更具剛性且更難以控制。 As noted, the handpiece (handle) is typically connected to the integrated controller by a cable or cord (including one for coolant, power, etc. delivery/return). The length of the hand piece software can be optimized for flexibility, support strength and length. The cable must be sufficiently supportable to allow for the delivery and return of the coolant (except for the RF energy and/or any sensor's power line) without kinking, which may additionally block or prevent the delivery of coolant to the therapeutic tip. . However, a cable having sufficient strength for a coolant may be too thick or too rigid, thus making it difficult to grasp. It has been determined that a flat cable (as illustrated herein) in which one of the various channels is configured in parallel can permit sufficient flexibility to allow for ease of control without sacrificing strength. In contrast, a round cable can be more rigid and more difficult to control.

類似地，在某些變化形式中，該系統可在手持件處或在控制器外殼處或在兩者處包括用於電纜之一可旋轉連接器。一可旋轉連接器可允許手持件相對於軟線/電纜(例如，相對於軟線之長度)旋轉。此可使手持件在治療期間較易於使用，其中其可旋轉以治療不同之患者區。另外，特定而言在給定手柄及電纜之必要重量之情形下，該系統可包括修改以增加治療患者時之使用者舒適性。舉例而言，在某些變化形式中，該系統包括一固持件以將電纜向上固持於工作區域上方，以使得使用者不必支撐軟線/電纜之全部重量。在某些變化形式中，軟線/電纜為約六英 尺長或較短。 Similarly, in some variations, the system can include a rotatable connector for one of the cables at the handpiece or at the controller housing or both. A rotatable connector can allow the handpiece to rotate relative to the cord/cable (e.g., relative to the length of the cord). This allows the hand piece to be easier to use during treatment, where it can be rotated to treat different patient areas. Additionally, in particular, given the necessary weight of the handle and cable, the system may include modifications to increase user comfort in treating the patient. For example, in some variations, the system includes a retaining member to hold the cable up over the work area such that the user does not have to support the full weight of the cord/cable. In some variations, the cord/cable is about six inches The length is shorter or shorter.

如下文中更詳細地闡述，手持件或手柄亦可經調適以增加使用舒適性及簡易性。除移除開關外，如上所述。 As explained in more detail below, the handpiece or handle can also be adapted to increase ease of use and ease of use. In addition to removing the switch, as described above.

手柄handle

圖17A至圖17C圖解說明用於一***重塑裝置之一手持件(手柄)之一個變化形式。此變化形式包括增強在對一典型患者之治療期間對手持件之控制的調適。使用本文中所闡述或此項技術中已知之重塑裝置中之任一者治療患者時之一個困難係操作者操縱手柄時所經歷之疲勞。典型手柄使用起來可笨拙，特定而言由於可需要充分抵靠患者之組織握持手柄以維持與組織之電連接以達成RF能量之有效遞送。另外，必須以相對於患者之一恰當定向握持裝置。***表面相對於***開口成角度，因此要求使用者相對於患者自各種角度旋轉手柄，以達成對治療區域之完全覆蓋。 17A-17C illustrate a variation of a handpiece (handle) for use in a vaginal remodeling device. This variation includes enhancing the adaptation of the control of the handpiece during treatment of a typical patient. One difficulty in treating a patient using any of the remodeling devices described herein or known in the art is the fatigue experienced by the operator when manipulating the handle. A typical handle can be awkward to use, in particular because it may be necessary to hold the handle sufficiently against the tissue of the patient to maintain electrical connection to the tissue for efficient delivery of RF energy. In addition, the device must be properly oriented with respect to one of the patients. The vaginal surface is angled relative to the vaginal opening, thus requiring the user to rotate the handle from various angles relative to the patient to achieve complete coverage of the treatment area.

在圖17A至圖17C中，手持件1701(顯示帶有附接之尖端1703)係一細長手柄，其經組態以使得其可易於由兩隻手握持，但其可充分地足夠輕而由一隻手握持。舉例而言，該手柄可有些筆直(細長)，沿與治療尖端相同之軸線在近端自遠端治療尖端延伸。該手柄可包括兩個抓握區，其可包括形成抓握區1705、1707之兩個或更多個淺「頸」區。 如上文所闡述，治療尖端可被連接且包括密封區以密封冷卻劑遞送線路及返回線路。該手柄可不具有致動按鈕(但在某些變化形式中，其可包括一啟動按鈕)；且可與一腳踏開關或其他啟動開關一同使用。 In Figures 17A-17C, handpiece 1701 (showing tip 1703 with attachment) is an elongated handle that is configured such that it can be easily held by both hands, but it can be sufficiently light enough Hold by one hand. For example, the handle may be somewhat straight (elongated) extending proximally from the distal treatment tip along the same axis as the treatment tip. The handle can include two gripping regions that can include two or more shallow "neck" regions that form the gripping regions 1705, 1707. As explained above, the treatment tip can be connected and include a sealing zone to seal the coolant delivery line and the return line. The handle may have no actuation button (but in some variations, it may include a start button); and may be used with a foot switch or other activation switch.

在某些變化形式中，手持件或治療尖端或兩者包括可指示在***內之深度之標記1721。此可允許使用者維持一所需使用深度。 In some variations, the handpiece or treatment tip or both include indicia 1721 that can indicate the depth within the vagina. This allows the user to maintain a desired depth of use.

圖18A至圖18D圖解說明穿過圖17A至圖17C中所示之例示性手柄之各種剖視圖。 18A-18D illustrate various cross-sectional views through the illustrative handles illustrated in Figures 17A-17C.

在圖17A至圖18D中所示之實例中，手持件及尖端為約13英吋長。圖18A至圖18D中所示之尺寸僅為例示性；可在不背離本發明之情形下修改此等尺寸(以英吋顯示)。一般而言，手柄充分長以便易於由兩隻手握持。該手柄可相對具剛性(舉例而言，與撓性、通常扁平之電纜相比)。在某些變化形式中，手柄係介於約8英吋與約16英吋長之間(例如，大於8英吋長，大於9英吋長，大於10英吋長，大於11英吋長，大於12英吋長，大於13英吋長，大於14英吋長等)。在某些變化形式中，該手柄(包括治療尖端)較佳大於約12英吋長(例如，13英吋長)，乃因其可允許雙手使用。該手柄可係剛性及輕重量(例如，內區可相對中空，如圖18D中所示)。因此，可用單手操縱該手柄，但其足夠長而可用雙手使用。 In the example shown in Figures 17A-18D, the handpiece and tip are about 13 inches long. The dimensions shown in Figures 18A through 18D are merely exemplary; such dimensions (shown in inches) may be modified without departing from the invention. In general, the handle is sufficiently long to be easily held by both hands. The handle can be relatively rigid (for example, compared to a flexible, generally flat cable). In some variations, the handle is between about 8 inches and about 16 inches long (eg, greater than 8 inches long, greater than 9 inches long, greater than 10 inches long, greater than 11 inches long, Greater than 12 inches long, greater than 13 inches long, greater than 14 inches long, etc.). In some variations, the handle (including the treatment tip) is preferably greater than about 12 inches long (e.g., 13 inches long) because it allows for both hands to be used. The handle can be rigid and lightweight (eg, the inner zone can be relatively hollow, as shown in Figure 18D). Therefore, the handle can be manipulated with one hand, but it is long enough to be used with both hands.

控制系統Control System

包括上文所闡述之整合式控制器之控制器可包括一顯示器，該顯示器經組態以顯示關於程序、冷卻劑、治療尖端、手柄及該系統之其他組件之資訊。此資訊可在整合式控制器之前部顯示，且亦可呈現帶有音頻信號之資訊。該顯示器亦可用以基於各種系統組件之狀態(例如，冷卻劑 位準、與皮膚之接觸、RF產生器狀態等)來顯示錯誤資訊(包括錯誤代碼)。 A controller including the integrated controller set forth above can include a display configured to display information about the program, coolant, treatment tip, handle, and other components of the system. This information can be displayed in front of the integrated controller and can also present information with audio signals. The display can also be used based on the status of various system components (eg, coolant) Level information, contact with the skin, RF generator status, etc.) to display error information (including error codes).

在一個特定實例中，該系統包括指示治療尖端之狀態之一顯示器。該治療尖端可包括複數個RF電極。舉例而言，該尖端可包括彼此鄰近配置之四個電極之一陣列。該尖端亦可包括用於指示每一電極是否與欲治療之組織適當接觸之複數個感測器。圖20A至圖20C圖解說明顯示器之三個例示性「螢幕」。 In one particular example, the system includes a display that indicates the status of the treatment tip. The treatment tip can include a plurality of RF electrodes. For example, the tip can include an array of one of four electrodes disposed adjacent one another. The tip can also include a plurality of sensors for indicating whether each electrode is in proper contact with the tissue to be treated. Figures 20A-20C illustrate three exemplary "screens" of a display.

在圖20A中，該螢幕已劃分成向使用者顯示狀態資訊及指令之五個區。舉例而言，該螢幕之右上部分以一計量圖標(滑尺)指示冷卻劑位準2001。其下方係治療尖端上之電極之一圖形表示2003。在此實例中，存在四個象限(1至4)。此等經標示象限可包括指示電極是否充分接觸患者以進行有效治療之一視覺指示符。如上所述，在某些變化形式中，此指示符可反映一阻抗及/或熱量測。在某些變化形式中，期望使用非電的(例如，非電阻或電阻抗的)與患者之接觸之確定；且用於達成此之一方法及系統之實例闡述於下文中。在圖20A中，接觸地圖2003指示四個象限中之每一者係充分接觸。在此情形中，顯示器之底部區2005通知使用者可藉由按下腳踏開關來開始治療。除接觸地圖指示治療尖端之電極未與患者充分接觸外，圖20B及圖20C類似於圖20A。在圖20B中，該等電極中沒有一個被確定為充分接觸，且因此在治療可進行之前系統指令使用者「進行患者接觸」。在圖20C中，接觸地圖指示一半電極(4 個當中的2個)與患者充分接觸，且資訊圖標指令使用者「進行更好的接觸」。圖20A至圖20C全部指示欲應用之治療位準(在此實例中係90焦耳/cm²)，以及欲應用之剩餘尖端脈衝(在此實例中係100)。剩餘尖端脈衝指示符下方之一滑尺在視覺上指示欲遞送以用於治療之脈衝之數目。在某些變化形式中，可藉由按壓「設定」按鈕2009且更改或輸入值來選擇或修改此等參數(用於治療之治療位準及脈衝)。 In Figure 20A, the screen has been divided into five zones for displaying status information and instructions to the user. For example, the upper right portion of the screen indicates the coolant level 2001 with a metering icon (sliding ruler). Below it is a graphical representation of one of the electrodes on the treatment tip. In this example, there are four quadrants (1 to 4). Such labeled quadrants can include a visual indicator indicating whether the electrode is in full contact with the patient for effective treatment. As noted above, in some variations, this indicator may reflect an impedance and/or heat measurement. In some variations, it is desirable to use a determination of non-electrical (e.g., non-resistive or electrical impedance) contact with a patient; and examples of one of the methods and systems for achieving this are set forth below. In Figure 20A, contact map 2003 indicates that each of the four quadrants is in full contact. In this case, the bottom area 2005 of the display informs the user that the treatment can be initiated by pressing the foot switch. Figures 20B and 20C are similar to Figure 20A except that the contact map indicates that the electrode of the treatment tip is not in full contact with the patient. In Figure 20B, none of the electrodes are determined to be in full contact, and thus the system instructs the user to "go patient contact" before treatment can proceed. In Figure 20C, the contact map indicates that half of the electrodes (two of the four) are in full contact with the patient, and the information icon instructs the user to "make better contact." 20A-20C all indicate the therapeutic level to be applied (90 Joules/cm ² in this example), as well as the remaining tip pulses (100 in this example) to be applied. One of the sliders below the remaining tip pulse indicator visually indicates the number of pulses to be delivered for treatment. In some variations, these parameters (therapeutic levels and pulses for treatment) can be selected or modified by pressing the "Set" button 2009 and changing or entering a value.

在操作中，使用者可使用一觸控螢幕來開始使用裝置，包括選擇激發參數，諸如欲遞送之治療位準及脈衝。下面係使用本文中所闡述之裝置之一所提議方法之一個說明。 In operation, the user can use a touch screen to begin using the device, including selecting excitation parameters such as the level of treatment and pulse to be delivered. The following is a description of one of the methods proposed by one of the devices set forth herein.

A.設置：調諧治療尖端A. Settings: Tune the treatment tip

在治療之前，在某些變化形式中，可「調諧」系統。 Before treatment, in some variations, the system can be "tuned".

該系統通常包括一手柄及經組態以密封且可移除地連接至該手柄之一治療尖端、一整合式控制器、RF產生器及冷卻子系統、將該手柄及尖端連接至該控制器之一電纜或軟線及連接至該控制器之一啟動腳踏開關。該系統亦可包括一返回墊(電返回)、一致冷劑(冷卻劑)罐及一耦合流體。該耦合流體可經提供以幫助達成尖端與患者之組織之間的充分電接觸。 The system generally includes a handle and a treatment tip configured to be sealingly and removably coupled to the handle, an integrated controller, an RF generator, and a cooling subsystem, the handle and tip being coupled to the controller One of the cables or cords and one of the controllers is activated to activate the foot switch. The system can also include a return pad (electrical return), a co-coolant (coolant) canister, and a coupling fluid. The coupling fluid can be provided to help achieve sufficient electrical contact between the tip and the tissue of the patient.

在某些變化形式中，該系統可係自我調諧。在某些變化形式中，該系統可允許使用者調諧施加器。為調諧該系統，可匹配尖端、手柄及控制器。在將一治療尖端安裝至產生器之手持件上後，產生器之使用者介面螢幕可經組態 而需要一調諧循環，以便設定所需RF能量位準。應執行以下步驟來完成該調諧循環： In some variations, the system can be self-tuning. In some variations, the system may allow a user to tune the applicator. To tune the system, the tip, handle and controller can be matched. The user interface screen of the generator can be configured after the treatment tip is mounted on the handpiece of the generator A tuning cycle is required to set the desired RF energy level. The following steps should be performed to complete the tuning cycle:

首先，確認產生器系統之電纜經恰當連接且患者返回電極墊完全且恰當地放置至患者。 First, it is confirmed that the cable of the generator system is properly connected and the patient return electrode pad is completely and properly placed to the patient.

接下來，在將治療尖端安裝至手持件上之後，等待直至產生器之使用者介面螢幕讀取而準備進行調諧。按下產生器之前面板上之確認按鈕且然後按下開始/停止按鈕。產生器之開始/停止按鈕現在應正在閃爍。若不閃爍，則再次按壓確認按鈕及開始/停止按鈕。若開始/停止按鈕不開始閃爍，則卸下治療尖端且將其重新安裝至手持件上且重複按下確認按鈕及開始/停止按鈕。 Next, after mounting the treatment tip onto the handpiece, it waits until the user interface screen reading of the generator is ready for tuning. Press the confirmation button on the front panel of the generator and then press the start/stop button. The start/stop button of the generator should now be flashing. If it does not flash, press the confirmation button and the start/stop button again. If the start/stop button does not begin to flash, remove the treatment tip and reattach it to the handpiece and press the confirmation button and the start/stop button repeatedly.

此後，將耦合流體施加至治療尖端之電極表面且然後將電極放置至***口內部之目標組織上。確保整個電極表面均勻地密封至***組織上。當到達適當組織溫度時，手持件上之藍色燈將變亮。 Thereafter, a coupling fluid is applied to the electrode surface of the treatment tip and the electrode is then placed onto the target tissue inside the vaginal opening. Ensure that the entire electrode surface is evenly sealed to the vaginal tissue. When the appropriate tissue temperature is reached, the blue light on the handpiece will light up.

在手持件上之藍色燈變亮之情形下且在維持與電極表面之組織接觸之同時，按壓位於手持件上之RF啟動按鈕或腳踏開關且按住，直至產生器之使用者介面螢幕顯示調諧完成。有時，產生器可需要多於一個調諧循環來完成調諧過程。若如此，則重複將電極放置至目標組織上且按下並按住RF啟動按鈕直至調諧完成。 Pressing the RF start button or foot switch on the handpiece while the blue light on the handpiece is brightened and while maintaining tissue contact with the electrode surface, until the user interface screen of the generator is pressed The display is complete. Sometimes the generator may require more than one tuning cycle to complete the tuning process. If so, place the electrode on the target tissue repeatedly and press and hold the RF start button until the tuning is complete.

在某些變化形式中，該系統不需要調諧，但可預調諧或匹配。 In some variations, the system does not require tuning but can be pre-tuned or matched.

在某些變化形式中，在開始程序之前，該系統可允許將 RF能量位準設定至一所需位準。舉例而言，使用一控制(例如，前面板上之一旋鈕、使用觸控螢幕之一圖形介面控制等)，可將RF能量位準改變為(例如)18.0(180J)且然後確認且可按下開始/停止按鈕或其他控制。 In some variations, the system allows for the system to be The RF energy level is set to a desired level. For example, using a control (eg, a knob on the front panel, using one of the touch screen graphical interface controls, etc.), the RF energy level can be changed to, for example, 18.0 (180J) and then confirmed and pressed Start/stop button or other controls.

在該系統之某些變化形式中，控制器之能量位準係不可調整的，但固定於已發現是有效之一特定能量位準或能量位準範圍處。舉例而言，在該系統之某些變化形式中，控制器之能量位準固定於約90J處。在其他變化形式中，能量位準限制於約80J至約130J(例如，90J至120J)之一範圍內。 In some variations of the system, the energy level of the controller is not adjustable, but is fixed at a particular energy level or energy level range that has been found to be effective. For example, in some variations of the system, the controller's energy level is fixed at approximately 90J. In other variations, the energy level is limited to a range from about 80 J to about 130 J (eg, 90 J to 120 J).

程序設置Program setting

在某些變化形式中，治療區域可被界定為在處女膜處開始之******口之黏膜表面，舉例而言，覆蓋自1：00位置至11：00位置之區域且避免緊在尿道下方且鄰近於尿道之區域之區。為設置以進行治療，使用者可首先使用一非基於酒精之清潔劑清潔並準備治療區域及***之周圍表面。 使用者然後可確認整合式控制(RF產生器、冷卻模組及控制)、手持件及腳踏開關(若使用)經恰當設置且經恰當連接。 In some variations, the treatment area can be defined as the mucosal surface of the vaginal vaginal opening starting at the hymen, for example, covering the area from 1:00 to 11:00 and avoiding the urethra and adjacent In the area of the area of the urethra. To be set up for treatment, the user may first clean and prepare the treatment area and the surrounding surface of the vagina using a non-alcohol based cleaner. The user can then confirm that the integrated controls (RF generator, cooling module and control), handpiece and foot switch (if used) are properly set up and properly connected.

此後，可將患者返回墊電極放置為與患者之下部背或側區域(臀部上方)上之皮膚之一清潔乾燥區域接觸且在使用之前治療尖端可完全按壓至手持件中。最佳地，治療尖端應與黏膜組織完全接觸以達成安全操作。為進行治療，可用耦合流體浸浴治療區域及治療尖端以確保與治療表面之 良好電接觸。可在治療程序期間應用額外耦合流體。 Thereafter, the patient return pad electrode can be placed in contact with a clean dry area of the skin on the back or side region (upper buttocks) of the lower portion of the patient and the treatment tip can be fully pressed into the handpiece prior to use. Optimally, the treatment tip should be in full contact with the mucosal tissue for safe operation. For treatment, a coupling fluid can be used to bathe the treatment area and the treatment tip to ensure a therapeutic surface Good electrical contact. Additional coupling fluids can be applied during the treatment procedure.

使用者可視需要使用具有一牽引器之裝置，但應小心不將治療尖端之施加器(電極)與任何牽引器接觸。在某些變化形式中，能量設定係180J。能量密度係90J/cm²。當確保治療尖端與治療表面良好地接觸且確認手持件上之藍色燈變亮時，可藉由啟動手持件上之開關或腳踏開關來將RF能量施加至目標區域。 The user may use a device with a retractor as needed, but care should be taken not to contact the applicator (electrode) of the treatment tip with any retractor. In some variations, the energy setting is 180J. The energy density is 90 J/cm ² . When it is ensured that the treatment tip is in good contact with the treatment surface and that the blue light on the handpiece is illuminated, RF energy can be applied to the target area by activating a switch or foot switch on the handpiece.

在某些變化形式(例如，使用本文中所闡述之治療尖端及裝置)中，每一能量施加可治療一1cm x 2cm區域。順時鐘開始，可將治療尖端可應用於在處女膜處開始之***口之***黏膜表面，覆蓋自1：00點鐘位置至11：00點鐘位置之整個區域，避開尿道。為確保完全覆蓋，能量施加可重疊50%或0.5cm²。可重複此步驟直至在治療區域中進行總共五(5)輪。 In some variations (eg, using the treatment tips and devices set forth herein), each energy application can treat a 1 cm x 2 cm region. Starting at the clock, the treatment tip can be applied to the vaginal mucosal surface of the vaginal opening starting at the hymen, covering the entire area from 1:00 o'clock to 11:00 o'clock, avoiding the urethra. To ensure complete coverage, the energy application can overlap by 50% or 0.5 cm ² . This step can be repeated until a total of five (5) rounds are performed in the treatment area.

接觸確認及系統控制Contact confirmation and system control

如上所述，系統可經組態以確認施加器尖端且特定而言能量施加器(例如，電極)與組織良好地接觸，以確保將充分地治療組織且防止受傷。在某些變化形式中，系統包括一顯示器，該顯示器包括顯示(藉由色彩、符號、文本等)正與尖端及/或能量施加器適當接觸之一「接觸地圖」。舉例而言，該接觸地圖可顯示能量施加器之一地圖，其指示每一能量施加器區之充分患者接觸。在圖20A至圖20C中，舉例而言，系統顯示施加器尖端之一四象限地圖且指示能量施加器是否與患者充分接觸。 As noted above, the system can be configured to confirm that the applicator tip and, in particular, the energy applicator (eg, electrode) are in good contact with the tissue to ensure that the tissue will be adequately treated and prevented from injury. In some variations, the system includes a display that includes a "contact map" that is displayed (by color, symbol, text, etc.) in proper contact with the tip and/or energy applicator. For example, the contact map can display a map of one of the energy applicators indicating sufficient patient contact for each energy applicator region. In Figures 20A-20C, for example, the system displays a four quadrant map of the applicator tip and indicates whether the energy applicator is in full contact with the patient.

在某些變化形式中，充分接觸意指充分電接觸，且可藉由施加來自電極之一低位準電流以確定接觸是否充分來確定(例如，量測電極與組織之間的電阻/電導)。然而，此意外地導致問題，乃因包括一RF產生器之裝置之EMC(電干擾)測試已證明電力線路連接上之不可接受量之所產生干擾。此問題可導致系統(例如，產生器)無法依從於EMC限制。 In some variations, sufficient contact means sufficient electrical contact and can be determined by applying a low level current from one of the electrodes to determine if the contact is sufficient (eg, measuring electrical resistance/conductance between the electrode and the tissue). However, this unexpectedly causes problems because the EMC (Electrical Interference) test of a device including an RF generator has demonstrated an unacceptable amount of interference on the power line connection. This issue can cause systems (for example, generators) to fail to comply with EMC restrictions.

此問題之原因可係使用接觸之電測試時固有的。舉例而言，在遞送治療RF能量之前，RF產生器組織接觸演算法通常使用電阻抗量測來偵測尖端完全處於空氣中還是與組織部分接觸。阻抗量測要求以一低位準致能RF輸出電路。此低位準在電力線路連接上產生電干擾。儘管RF產生器在治療能量遞送期間通常免除依從於EMC限制，但此免除可不適用於預施加(例如，接觸測試)。 The cause of this problem can be inherent to the electrical test of the contact. For example, prior to delivering therapeutic RF energy, the RF generator tissue contact algorithm typically uses electrical impedance measurements to detect whether the tip is completely in the air or in contact with the tissue portion. Impedance measurement requires an RF output circuit with a low level. This low level creates electrical interference on the power line connection. Although RF generators are generally exempt from EMC restrictions during therapeutic energy delivery, this exemption may not be suitable for pre-application (eg, contact testing).

本文中闡述一種不需要在遞送治療能量之前致能RF輸出電路之確定尖端與組織之接觸之系統及方法。 A system and method for determining the contact of a tip with tissue prior to the delivery of therapeutic energy prior to delivery of therapeutic energy is set forth herein.

在本文中所闡述之系統的某些變化形式中，治療尖端包括複數個溫度感測元件(例如，測溫電阻器)。舉例而言，該系統可包括六個測溫電阻器，其等包圍四個電極(例如，在其等之邊緣處)。在一個變化形式中，該系統可使用來自所有或一子組測溫電阻器之溫度資訊與裝置之使用歷史及計時之一組合來確定對於系統之操作是否存在與患者之充分接觸。 In some variations of the systems set forth herein, the treatment tip includes a plurality of temperature sensing elements (eg, temperature measuring resistors). For example, the system can include six temperature measuring resistors that surround four electrodes (eg, at the edges thereof). In one variation, the system can use a combination of temperature information from all or a subset of temperature measuring resistors and one of the device's usage history and timing to determine if there is sufficient contact with the patient for operation of the system.

在可與一阻抗/電阻量測一同使用之一個變化形式中，若系統確定一電極具有通常為空氣中之阻抗之一高阻抗， 則該系統將指示電極未與組織接觸。若該阻抗係低(在可指示與組織接觸之一範圍內)，則該系統可指示接觸。然而，由於接觸可不完全或不夠充分，因此在某些變化形式中，可使用溫度作為一備份來確認電極與組織接觸。舉例而言，當一電極之阻抗係低時，可將該電極處(例如，該電極之一角落處)之溫度與一臨限溫度相比較以確認接觸。此臨限溫度通常係一常數(例如，16攝氏度)。舉例而言，若實際溫度為約16攝氏度或大於約16攝氏度，則當阻抗係低時，該系統可指示電極充分接觸。 In a variation that can be used with an impedance/resistance measurement, if the system determines that an electrode has a high impedance, typically one of the impedances in air, The system will then indicate that the electrode is not in contact with the tissue. If the impedance is low (within one of the indications of contact with the tissue), the system can indicate the contact. However, since the contact may not be complete or insufficient, in some variations, the temperature may be used as a backup to confirm that the electrode is in contact with the tissue. For example, when the impedance of an electrode is low, the temperature at the electrode (eg, at a corner of the electrode) can be compared to a threshold temperature to confirm contact. This threshold temperature is usually a constant (for example, 16 degrees Celsius). For example, if the actual temperature is about 16 degrees Celsius or greater than about 16 degrees Celsius, the system can indicate that the electrodes are in sufficient contact when the impedance is low.

然而，此「恆定溫度」臨限值可引入錯誤，特定而言由於電極之周圍環境溫度可大於16度；即使在電極之操作之後，當電極藉由冷卻劑之施加而冷卻時，尖端將升溫至高於此恆定臨限值。 However, this "constant temperature" threshold can introduce errors, in particular because the ambient temperature of the electrode can be greater than 16 degrees; even after the operation of the electrode, when the electrode is cooled by the application of the coolant, the tip will heat up. To above this constant threshold.

作為一替代方案，該系統可經組態以使得阻抗量測因只利用溫度量測及自從應用最後一次治療(冷卻劑)以來之時間而係不必要的。 As an alternative, the system can be configured such that impedance measurements are not necessary due to temperature measurements alone and since the last treatment (coolant) was applied.

舉例而言，該系統可追蹤(例如，使用一計時元件)自從最後一次治療以來之時間，且基於尖端(例如，電極)之溫度及自從最後一次治療以來之該時間應用一臨限值。若一治療已~30秒未發生，則尖端可能正接近周圍環境溫度且因此應使用一穩定增加之溫度臨限值。在~3分鐘之後，尖端將接近周圍環境溫度且該系統可應用高於周圍環境(但低於體溫)之一固定較高臨限值。若自從最後一次治療流逝之時間少於一最少時間(~30秒)，則尖端溫度可仍低 於周圍環境且可將溫度臨限值設定於一低值處以最小化下一治療循環之等待時間。 For example, the system can track (eg, using a timing component) the time since the last treatment and apply a threshold based on the temperature of the tip (eg, the electrode) and the time since the last treatment. If a treatment has not occurred for ~30 seconds, the tip may be approaching the ambient temperature and a steady increase in temperature threshold should therefore be used. After ~3 minutes, the tip will approach the ambient temperature and the system can apply a higher threshold than one of the surrounding environment (but below body temperature). If the time since the last treatment has elapsed for less than a minimum time (~30 seconds), the tip temperature may still be low In the surrounding environment, the temperature threshold can be set to a low value to minimize the waiting time for the next treatment cycle.

舉例而言，在一個變化形式中，該系統不使用阻抗量測來確認接觸，但僅依賴於溫度及自從裝置之最後一次啟動(施加冷卻劑)以來之時間。可將一電極之溫度與相依於自從裝置之最後一次啟動以來之時間之一溫度臨限值相比較；此關係可係一非恆定關係。特定而言，該關係可描述具有不同溫度之時間「區」。在某些變化形式中，該臨限值關係係一階躍函數、一反正切函數或其他關係。該臨限值關係可稱作提供一臨限溫度之一臨限函數(其為時間之一函數)。該臨限函數通常並非一常數(在所有時間內)，但其可具有其在其中為一常數之時間區。一例示性臨限函數圖解說明於圖21中(「所提議臨限值」)且與空氣中之一尖端之溫度及一恆定臨限值相比較。 For example, in one variation, the system does not use impedance measurements to confirm contact, but only depends on temperature and time since the last start of the device (application of coolant). The temperature of an electrode can be compared to a temperature threshold that is dependent on the time since the last start of the device; this relationship can be in a non-constant relationship. In particular, the relationship can describe time zones with different temperatures. In some variations, the threshold relationship is a step function, an inverse tangent function, or other relationship. This threshold relationship can be referred to as providing a threshold function of one threshold temperature (which is a function of time). The threshold function is usually not a constant (at all times), but it can have a time zone in which it is a constant. An exemplary threshold function is illustrated in Figure 21 ("Proposed Threshold") and compared to the temperature of one of the tips in the air and a constant threshold.

表1中之實例假定，若一治療已~30秒未發生，則尖端正接近周圍環境溫度且因此應應用一穩定增加之溫度臨限值來確定電極是否與患者(其組織將處於體溫)充分接觸。在~3分鐘之後，尖端將接近周圍環境溫度且該系統將使用高於周圍環境(但低於體溫)之一固定較高臨限值。若自從最後一次治療流逝之時間少於一最少時間(~30秒)，則尖端溫度仍低於周圍環境且溫度臨限值將保持於該低值處以最小化下一治療循環之等待時間。 The example in Table 1 assumes that if a treatment has not occurred for ~30 seconds, the tip is approaching the ambient temperature and therefore a steadily increasing temperature threshold should be applied to determine if the electrode is adequate with the patient (the tissue will be at body temperature) contact. After ~3 minutes, the tip will approach the ambient temperature and the system will use a higher threshold than one of the surrounding environment (but below body temperature). If the time since the last treatment has elapsed for less than a minimum time (~30 seconds), the tip temperature is still below the ambient and the temperature threshold will remain at this low value to minimize the waiting time for the next treatment cycle.

在表一中，標題為「組織接觸確定」之行給出電極之多個量測/尖端接觸之綜合之一實例，其可用於確定總的尖端接觸是否充分而在程序中進行能量之施加。在此實例中，若超過一半(例如，4個中之3個)接觸確定(來自四個電極中之每一者之角落附近之四個測溫電阻器)高於來自臨限函數之臨限溫度，則控制器可允許(或在某些變化形式中只是建議)在當前位置中進行治療；否則可不准許或建議治療。在某些變化形式中，基於臨限函數至複數個測溫電阻器之應用之「良好」接觸之數目可大於某一其他百分比(例如，60%、75%、80%、90%等)或所有測溫電阻器必須高於臨限函數溫度。在某些變化形式中，測溫電阻器之位置可經加權以確定是否准許或建議使用者進行治療。舉例而言，跨越組織(表示緊鄰近之電極)形成一連續水平(或連續垂直)線之測溫電阻器在確定充分接觸以進行治療時可較重地加權。 In Table 1, the row entitled "Organizational Contact Determination" gives an example of a combination of multiple measurements/tip contacts of the electrodes that can be used to determine if the total tip contact is sufficient for energy application in the procedure. In this example, if more than half (eg, 3 out of 4) contact determinations (four temperature-measuring resistors near the corners of each of the four electrodes) are higher than the threshold from the threshold function At the temperature, the controller may allow (or only suggest in some variations) to perform treatment in the current location; otherwise treatment may not be permitted or recommended. In some variations, the number of "good" contacts based on the application of the threshold function to the plurality of temperature measuring resistors may be greater than some other percentage (eg, 60%, 75%, 80%, 90%, etc.) or All temperature measuring resistors must be above the threshold function temperature. In some variations, the position of the temperature measuring resistor can be weighted to determine whether the user is permitted or advised to perform the treatment. For example, a temperature-measuring resistor that forms a continuous horizontal (or continuous vertical) line across a tissue (representing an electrode immediately adjacent) can be weighted more heavily when determining sufficient contact for treatment.

圖21圖解說明基於一臨限函數之一所提議臨限值(類似 於上表1中所概述之一者)與一尖端之溫度及一恆定臨限值相比較之一個變化形式。即使在不存在偵測空氣中之一尖端之一阻抗量測之情形下，圖21中之所提議臨限值之臨限函數所顯示之穩定增加之溫度臨限值可防止完全或部分在空氣中之一尖端指示一準備治療狀態；在自從最後一次RF遞送以來之30秒與180秒之間使臨限值斜升可追蹤空氣中之一尖端溫度之連續升高。可調諧所提議臨限值曲線(臨限函數)以最佳化對假接觸感測之拒絕，同時最小化真正接觸感測之等待時間。 Figure 21 illustrates the proposed threshold based on one of the threshold functions (similar One of the variations outlined above in Table 1 is compared to a tip temperature and a constant threshold. Even in the absence of an impedance measurement of one of the tips in the detection air, the steadily increasing temperature threshold indicated by the threshold function of the proposed threshold in Figure 21 prevents complete or partial air One of the tips indicates a state of preparation for treatment; the threshold is ramped up between 30 seconds and 180 seconds since the last RF delivery to track a continuous rise in one of the tip temperatures in the air. The proposed threshold curve (threshold function) can be tuned to optimize rejection of false contact sensing while minimizing the latency of true contact sensing.

可在不背離本發明之範疇之情形下採用系統、治療尖端設計及相關聯使用方法之其他變化形式來達成本發明之目的，如熟習此項技術者將瞭解。亦可考量生理學及解剖學資訊來調整設備(包括手柄及尖端)之形狀及尺寸以增強治療之有效性。雖然本文中已顯示並闡述本發明之各種實施例，但僅以舉例方式提供此等實施例。本文中所提供之任何操作理論或益處既定僅作為闡述本發明之一輔助；此等理論及解釋不束縛或限制關於藉由實踐本發明而達成之組織重塑之申請專利範圍。熟習此項技術者現可在不背離本發明之情形下構想出諸多變化、改變及替代。應瞭解，可在實踐本發明時採用本文中所闡述之本發明之實施例的各種替代方案。本發明之範疇、本發明之範疇內之方法及結構既定包括等效形式。 Other variations of the system, therapeutic tip design, and associated methods of use may be employed to achieve the objectives of the present invention without departing from the scope of the invention, as will be appreciated by those skilled in the art. Physiological and anatomical information can also be considered to adjust the shape and size of the device (including the handle and tip) to enhance the effectiveness of the treatment. While various embodiments of the invention have been shown and described, Any theory or benefit of operation provided herein is intended to be merely an aid to the description of the present invention; such theory and explanations do not limit or limit the scope of the patent application for the remodeling of the organization by the practice of the invention. A person skilled in the art can now contemplate many variations, modifications and substitutions without departing from the invention. It will be appreciated that various alternatives to the embodiments of the invention set forth herein may be employed in the practice of the invention. The methods and structures within the scope of the invention, within the scope of the invention, are intended to include equivalents.

2‧‧‧手持件 2‧‧‧Handpieces

10‧‧‧治療尖端 10‧‧‧Treatment tip

15‧‧‧連接器部分 15‧‧‧Connector section

20‧‧‧軸 20‧‧‧Axis

24‧‧‧窄中間區段 24‧‧‧Narrow middle section

26‧‧‧外殼 26‧‧‧Shell

28‧‧‧遠端部分 28‧‧‧ distal part

29‧‧‧內部空間 29‧‧‧Internal space

30‧‧‧能量遞送元件 30‧‧‧ Energy delivery components

31‧‧‧線 31‧‧‧ line

35‧‧‧導電部分 35‧‧‧Electrical part

36‧‧‧電介質部分 36‧‧‧Dielectric section

38‧‧‧測溫電阻器(熱感測器) 38‧‧‧ Temperature measuring resistor (thermal sensor)

54‧‧‧冷卻管腔 54‧‧‧Cooling lumen

56‧‧‧噴嘴 56‧‧‧Nozzles

100‧‧‧黏膜上皮 100‧‧‧mucosal epithelium

102‧‧‧黏膜下層 102‧‧‧Submucosa

104‧‧‧肌肉 104‧‧‧ muscle

106‧‧‧肌肉 106‧‧‧ muscles

114‧‧‧***口 114‧‧‧Vaginal opening

120‧‧‧Hart氏線 120‧‧‧Hart's line

122‧‧‧*** 122‧‧‧Vaginal

124‧‧‧***口 124‧‧‧Vaginal opening

126‧‧‧外陰 126‧‧‧ vulva

130‧‧‧尿道 130‧‧‧ urethra

136‧‧‧參考時鐘刻度盤 136‧‧‧Reference clock dial

1001‧‧‧內表面 1001‧‧‧ inner surface

1003‧‧‧重疊圓圈 1003‧‧‧ overlapping circles

1005‧‧‧圓錐形噴灑型樣 1005‧‧‧Conical spray pattern

1009‧‧‧相對表面 1009‧‧‧relative surface

1101‧‧‧手柄 1101‧‧‧handle

1201‧‧‧裝置 1201‧‧‧ device

1203‧‧‧冷卻室 1203‧‧‧Cooling room

1205‧‧‧能量遞送組件 1205‧‧‧Energy delivery components

1207‧‧‧噴嘴 1207‧‧‧ nozzle

1301‧‧‧尖端 1301‧‧‧ cutting-edge

1303‧‧‧手柄 1303‧‧‧handle

1313‧‧‧附接區 1313‧‧‧ Attachment area

1500‧‧‧系統 1500‧‧‧ system

1501‧‧‧顯示器 1501‧‧‧ display

1503‧‧‧外殼 1503‧‧‧Shell

1505‧‧‧手柄 1505‧‧‧handle

1507‧‧‧治療尖端 1507‧‧‧Treatment tip

1509‧‧‧電纜 1509‧‧‧ cable

1521‧‧‧罐 1521‧‧‧cans

1701‧‧‧手持件 1701‧‧‧Handpieces

1703‧‧‧尖端 1703‧‧‧ cutting edge

1705‧‧‧抓握區 1705‧‧‧ grasping area

1707‧‧‧抓握區 1707‧‧‧ grasping area

1721‧‧‧標記 1721‧‧‧ mark

2001‧‧‧冷卻劑位準 2001‧‧‧ coolant level

2003‧‧‧圖形表示 2003‧‧‧ graphical representation

2005‧‧‧底部區 2005‧‧‧Bottom area

2009‧‧‧按鈕 2009‧‧‧ button

圖1係用於將輻射能量施加至目標組織同時使上皮冷卻 以便重塑生殖組織之一設備之一透視圖，其顯示一手持件及一所連接治療尖端；圖2係一治療尖端實施例之一分解透視圖；圖3係一治療尖端實施例之一分解側視圖；圖4係該治療尖端之一正面剖視圖，其顯示下伏於接觸上皮之能量遞送元件下面的冷卻噴嘴；圖5顯示具有(A)一單個單極電極、(B)一單個雙極電極及(C)多對雙極電極之治療尖端實施例之正視圖；圖6A及圖6B顯示一治療尖端之兩個實施例之前透視圖，治療側面向上，其中圖6A顯示具有一扁平表面之一電極，且圖6B顯示具有一彎曲表面之一電極；圖7係女性生殖器之一示意圖，其繪示上覆目標組織之黏膜上皮表面以及用以提供***壁之一圓周參考方案之一定向時鐘；圖8顯示接觸一生殖上皮黏膜表面以及包括固有層及肌肉之下伏目標組織之一治療尖端；圖9A及圖9B繪示一黏膜上皮之包含多個接觸位點之一治療區域(圖9A)及該治療區域作為一映射表格之一表示(圖9B)；圖10A顯示對著一能量施加器(諸如圖4中所示之一者)之一內部表面之一冷卻劑噴灑型樣。圖10B圖解說明圖4中所示之施加器尖端之一內部冷卻腔內之一冷卻劑噴灑之一側透視圖；圖11圖解說明經組態以連接至一施加器尖端之一施加器 之一手柄區之一個變化形式；圖12係穿過一裝置之包括內部冷卻室或管腔之一尖端施加器之一縱向剖視圖；圖13顯示穿過一尖端與手柄之介接區之一剖視圖；圖14A顯示對著一能量施加器之一內部表面之一冷卻劑噴灑型樣。圖14B圖解說明一施加器尖端之一側透視圖，該施加器尖端包括在該施加器尖端之一內部冷卻腔內應用之一冷卻劑噴灑；圖15A至圖15F圖解說明用於治療***及鄰近組織之一系統之一個變化形式，該系統包括連接至一整合式控制器、供電源及冷卻劑之一手柄(手持件)及治療尖端；圖16A至圖16C顯示一系統(諸如圖15A至圖15F中所示之一者)之各種視圖及例示性尺寸；圖17A至圖17C圖解說明包括一治療尖端之一手柄之一個變化形式，其係分別自一俯視圖、側視圖及仰視圖顯示；圖18A至圖18E顯示穿過圖17A至圖17C中所示之例示性手柄之剖視圖；圖19A至圖19E圖解說明形成手柄所附接至之整合式控制器、電力產生器及冷卻劑系統之內部底盤之一個變化形式；圖20A至圖20C顯示如本文中所闡述之一例示性系統之控制螢幕之不同實例；及圖21係顯示尖端在空氣中之溫度對自從最後一次治療以 來之時間的關係之一曲線圖，可使用該關係來計算一電極是否與一組織充分接觸以起始治療。 Figure 1 is used to apply radiant energy to the target tissue while cooling the epithelium A perspective view of one of the devices for reshaping the reproductive tissue, showing a handpiece and a connected treatment tip; FIG. 2 is an exploded perspective view of one of the treatment tip embodiments; and FIG. 3 is an exploded view of one of the treatment tip embodiments Figure 4 is a front cross-sectional view of one of the treatment tips showing a cooling nozzle underneath the energy delivery element contacting the epithelium; Figure 5 shows (A) a single monopolar electrode, (B) a single bipolar Front view of a treatment tip embodiment of an electrode and (C) multiple pairs of bipolar electrodes; Figures 6A and 6B show a front perspective view of two embodiments of a treatment tip with the treatment side up, wherein Figure 6A shows a flat surface An electrode, and FIG. 6B shows an electrode having a curved surface; FIG. 7 is a schematic view of a female genitalia showing the mucosal epithelial surface overlying the target tissue and a directional clock for providing one of the circumferential reference schemes of the vaginal wall Figure 8 shows a treatment tip contacting a genital epithelial mucosal surface and including a lamina propria and a target tissue beneath the muscle; Figures 9A and 9B depict a mucosal epithelium comprising a plurality of contact sites. The treatment area (Fig. 9A) and the treatment area are represented as one of a mapping table (Fig. 9B); Fig. 10A shows one of the internal surfaces of one of the energy applicators (such as one shown in Fig. 4) Spray the pattern. Figure 10B illustrates a side perspective view of one of the coolant sprays within one of the internal cooling chambers of the applicator tip shown in Figure 4; Figure 11 illustrates one of the applicators configured to connect to an applicator tip a variation of one of the handle regions; Figure 12 is a longitudinal cross-sectional view of one of the tip applicators including an internal cooling chamber or lumen through a device; Figure 13 shows a cross-sectional view through one of the interface regions of the tip and the handle Figure 14A shows a coolant spray pattern against one of the internal surfaces of an energy applicator. Figure 14B illustrates a side perspective view of an applicator tip including a coolant spray applied within an internal cooling chamber of one of the applicator tips; Figures 15A-15F illustrate treatment of the vagina and adjacent A variation of one of the systems comprising a handle (handpiece) connected to an integrated controller, power supply and coolant, and a treatment tip; Figures 16A-16C show a system (such as Figure 15A to Figure Various views and exemplary dimensions of one of those shown in FIG. 15A; FIGS. 17A-17C illustrate a variation of a handle including a treatment tip, which are shown from a top view, a side view, and a bottom view, respectively; 18A through 18E show cross-sectional views through the illustrative handles shown in Figs. 17A through 17C; Figs. 19A through 19E illustrate the interior of the integrated controller, power generator, and coolant system to which the handle is attached A variation of the chassis; Figures 20A-20C show different examples of control screens of an exemplary system as set forth herein; and Figure 21 shows the temperature of the tip in air since the last Treatments to A graph of the relationship between time and time that can be used to calculate whether an electrode is in full contact with a tissue to initiate treatment.

2‧‧‧手持件 2‧‧‧Handpieces

10‧‧‧治療尖端 10‧‧‧Treatment tip

15‧‧‧連接器部分 15‧‧‧Connector section

24‧‧‧窄中間區段 24‧‧‧Narrow middle section

28‧‧‧遠端部分 28‧‧‧ distal part

30‧‧‧能量遞送元件 30‧‧‧ Energy delivery components

Claims (14)

一種用於重塑女性生殖組織之黏膜上皮下面的組織內之一治療區之設備，該設備包含：一細長手柄，其經組態以握持於兩隻手內；及一治療尖端，其經組態以可移除地耦合至該細長手柄，該尖端包含：一軸，其包含一縱向軸線；一能量遞送元件，其具有一上皮接觸表面；及一內部冷卻室，其經組態以在內部使該能量遞送元件冷卻，其中該能量遞送元件包含經調適以允許在發射RF能量以加熱目標組織時使該上皮冷卻之一熱傳導表面；一控制器，其經結構設計以操作該尖端並判定該尖端與該上皮是否已充分接觸以用於有效治療；及一顯示器，其經構形以顯示一圖形，該圖形指示該尖端與該上皮之接觸狀態。 An apparatus for reshaping a treatment area in a tissue beneath a mucosal epithelium of a female reproductive tissue, the apparatus comprising: an elongated handle configured to be held in both hands; and a treatment tip having a Reconfigurably coupled to the elongate handle, the tip comprising: a shaft including a longitudinal axis; an energy delivery element having an epithelial contact surface; and an internal cooling chamber configured to be internal Cooling the energy delivery element, wherein the energy delivery element comprises a heat transfer surface adapted to allow the epithelium to cool upon emission of RF energy to heat the target tissue; a controller configured to operate the tip and determine the Whether the tip is in sufficient contact with the epithelium for effective treatment; and a display configured to display a graphic indicating the state of contact of the tip with the epithelium. 如請求項1之設備，其中該能量遞送元件經構形以平行於該軸之該縱向軸線。 The device of claim 1, wherein the energy delivery element is configured to be parallel to the longitudinal axis of the shaft. 如請求項1之設備，其中該能量遞送元件經構形而具有0.75cm至1.25cm之一寬度。 The device of claim 1, wherein the energy delivery element is configured to have a width of from 0.75 cm to 1.25 cm. 如請求項1之設備，其中該能量遞送元件經組態而具有1cm至3cm之一長度。 The device of claim 1, wherein the energy delivery element is configured to have a length of from 1 cm to 3 cm. 如請求項1之設備，其中該能量遞送元件經組態而係扁平的。 The device of claim 1, wherein the energy delivery element is configured to be flat. 如請求項1之設備，其中該內部冷卻室包含經組態以在該能量遞送元件之一內部部分上噴灑冷卻流體之複數個冷卻劑噴嘴。 The apparatus of claim 1, wherein the internal cooling chamber comprises a plurality of coolant nozzles configured to spray a cooling fluid on an interior portion of the energy delivery element. 如請求項6之設備，其包含三個冷卻劑噴嘴。 The apparatus of claim 6 comprising three coolant nozzles. 如請求項1之設備，其中該能量遞送元件包含至少一個RF電極。 The device of claim 1, wherein the energy delivery element comprises at least one RF electrode. 如請求項1之設備，其進一步包含位於極接近於該能量遞送元件處之至少一個溫度感測器。 The device of claim 1, further comprising at least one temperature sensor located proximate to the energy delivery element. 如請求項1之設備，其進一步包含在近端自該細長手柄延伸之一返回冷卻劑通路，其經組態而以通道方式引導已使用之冷卻劑離開一患者。 The device of claim 1, further comprising returning a coolant passage at a proximal end from one of the elongated handle extensions configured to channel the used coolant away from a patient. 如請求項1之設備，其進一步包含將該細長手柄連接至整合式控制器之一扁平電纜，該電纜包括一冷卻劑遞送通道及一冷卻劑返回通道、至少一個RF電力線路。 The apparatus of claim 1 further comprising a flat cable connecting the elongated handle to an integrated controller, the cable including a coolant delivery passage and a coolant return passage, at least one RF power line. 如請求項1之設備，其中該細長手柄不包括控制RF能量之施加之一按鈕或開關。 The device of claim 1, wherein the elongated handle does not include a button or switch that controls the application of RF energy. 如請求項1之設備，其中該細長手柄沿一縱向方向延伸；其中該治療尖端包含複數個能量遞送元件，其等具有上皮接觸表面，其中該能量冷卻室包含至少一個內部冷卻室，該至少一個內部冷卻室經構形以在內部使該等能量遞送元件冷卻，且其中該控制器包括：一外殼； 該外殼內之一RF產生器；及該外殼內之一冷卻子系統。 The device of claim 1, wherein the elongated handle extends in a longitudinal direction; wherein the treatment tip comprises a plurality of energy delivery elements having an epithelial contact surface, wherein the energy cooling chamber comprises at least one internal cooling chamber, the at least one The internal cooling chamber is configured to internally cool the energy delivery elements, and wherein the controller comprises: a housing; An RF generator within the housing; and a cooling subsystem within the housing. 如請求項1之設備，其中該顯示器經構形以顯示指示接觸狀態之該複數個能量遞送元件之一圖形。 The device of claim 1, wherein the display is configured to display a graphic of the plurality of energy delivery elements indicative of a contact state.