Abstract:
A method and system of providing therapy to a patient&#39;s uterus. The method includes the steps of inserting an access tool through a cervix and a cervical canal into the uterus; actively cooling the cervical canal; delivering vapor through the access tool lumen into the uterus; and condensing the vapor on tissue within the uterus. The system has an access tool with a lumen, the access tool being adapted to be inserted through a human cervical canal to place an opening of the lumen within a uterus when the access tool is inserted through the cervical canal; an active cooling mechanism adapted to cool the cervical canal, the active cooling mechanism having a coolant source; and a vapor delivery mechanism adapted to deliver condensable vapor through the access tool to the uterus, the condensable vapor being adapted to condense within the uterus.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit under 35 U.S.C. §119 of U.S. Provisional Application No. 60/957,626, filed Aug. 23, 2007, the disclosure of which is incorporated by reference as if fully set forth herein. 
     This application is related to U.S. application Ser. No. 12/197,096, filed Aug. 22, 2008, entitled “Uterine Therapy Device and Method”; and to U.S. application Ser. No. 12/197,104, filed Aug. 22, 2008, entitled “Uterine Therapy Device and Method”; and to U.S. application Ser. No. 12/197,111, filed Aug. 22, 2008, entitled “Uterine Therapy Device and Method”, all of which are commonly owned. 
    
    
     INCORPORATION BY REFERENCE 
     All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. 
     BACKGROUND OF THE INVENTION 
     Endometrial ablation (i.e., the removal or destruction of the endometrial lining of the uterus) is used as an alternative to hysterectomy for treating menorrhagia, or other uterine diseases. One prior technique for performing endometrial ablation employ a resectoscope (i.e., a hysteroscope with a built-in wire loop or other ablative devices) that is inserted transcervically into the uterus, and uses radio-frequency electrical current (RF current) to remove or coagulate the endometrial tissue. These standard techniques typically are performed in a hospital setting. 
     Some approaches make use of heated fluid to ablate the endometrium. For example, early journal articles describe the use of steam to treat uterine hemorrhage. See, e.g., Van de Velde, “Vapo-“Cauterization of the Uterus,” Amer. J. Med. Sci., vol. CXVIII (1899); Blacker, “Vaporization of the Uterus,” J. Obstet. &amp; Gyn., pp. 488-511 (c. 1901). The use of steam for this purpose was later discredited, apparently due to patient morbidity and mortality. See, e.g., Fuller U.S. Pat. No. 6,139,571. More recent descriptions of the use of injecting hot fluid into the uterus may be found in Goldrath U.S. Pat. No. 5,451,208 and Evans et al. U.S. Pat. No. 5,540,658; U.S. Pat. No. 5,437,629. 
     Uterine therapies employing a contained fluid have also been described. See, e.g., Quint U.S. Pat. No. 5,084,044; Chin U.S. Pat. No. 5,449,380; Neuwirth et al., “The Endometrial Ablator: A New Instrument”, Obst. &amp; Gyn., 1994, Vol. 83, No. 5, Part 1, pp 792-796. Another balloon-based system using ultrasound as the energy source is described in U.S. Pat. No. 7,004,940. 
     High frequency, or radiofrequency (RF), energy has been used to perform thermal ablation of endometrial tissue. See, e.g., Prior et al., “Treatment of Mennorrhagia By Radiofrequency Heating”, Int. J. Hyperthermia, 1991 Vol. 7, No. 2, pp. 213-220; Stern et al. U.S. Pat. No. 5,443,470; U.S. Pat. No. 5,769,880; U.S. Pat. No. 6,929,642. 
     Current products for performing endometrial ablation include the NovaSure® procedure and a system marketed under the trade name THERMACHOICE®, by Ethicon, Inc. of Somerville, N.J. 
     Cryogenic ablation, or “cryoablation,” is another endometrial treatment approach. See, e.g., Droegemueller et al. U.S. Pat. No. 3,924,628; U.S. Pat. No. 6,306,129; and U.S. Pat. No. 7,101,367. 
     Finally, U.S. Pat. Appl. Publ. No. 2004/0068306 describes the use of vapor, such as steam, for endometrial or other tissue ablation, and U.S. Pat. Appl. Publ. No. 2002/0177846 describes the use of vapor for treating uterine fibroids. 
     SUMMARY OF THE INVENTION 
     One aspect of the invention provides a method of providing therapy to a patient&#39;s uterus. The method includes the steps of inserting an access tool through a cervix and a cervical canal into the uterus; actively cooling the cervical canal; delivering vapor through the access tool lumen into the uterus; and condensing the vapor on tissue within the uterus. In some embodiments, the step of actively cooling comprising supplying a flow of coolant through a coolant flowpath in the access tool. The access tool may have an expandable member (such as, e.g., a balloon), in which case the coolant flowpath may be disposed within the expandable member, and the expandable member may be expanded with the coolant. The coolant flowpath may also have a coolant inlet communicating with a coolant source and a coolant outlet communicating with an interior volume of the expandable member, in which case the supplying step may include the step of supplying coolant flow from the coolant inlet through the coolant outlet. The coolant flowpath may also be a coolant lumen formed in the access tool, in which case the supplying step may include the step of supplying coolant flow from the coolant inlet through the coolant lumen. 
     In some embodiments, the method also includes the step of sealing an interior cervical os after the inserting step, e.g., by expanding an expandable member such as a balloon. The expanding step may also include the step of preferentially expanding a sealing portion of the balloon disposed at the interior cervical os prior to expanding an indicator portion of the balloon disposed proximal to the interior cervical os. The balloon may be expanded with coolant. 
     Some embodiments of the invention include the step of placing an expansion mechanism in contact with tissue within the uterus to move uterine tissue away from an opening in the lumen. The method may also include the step of advancing the expansion mechanism distally prior to the placing step. 
     In some embodiments, the step of delivering vapor includes the step of inserting a vapor delivery tool through the access tool lumen. The method may also include the step of exhausting vapor and vapor condensate from the uterus. 
     Another aspect of the invention provides a uterine heat therapy system including: an access tool with a lumen, the access tool being adapted to be inserted through a human cervical canal to place an opening of the lumen within a uterus when the access tool is inserted through the cervical canal; an active cooling mechanism adapted to cool the cervical canal, the active cooling mechanism having a coolant source; and a vapor delivery mechanism adapted to deliver condensable vapor through the access tool to the uterus, the condensable vapor being adapted to condense within the uterus. The access tool may have further a coolant flowpath communicating with the coolant source. The access tool may also have an expandable member (such as a balloon), with the coolant flowpath being disposed within the expandable member. The coolant flowpath may include a coolant inlet communicating with the coolant source and a coolant outlet communicating with an interior volume of the expandable member. The coolant flowpath may also be a coolant lumen formed in the access tool. 
     In some embodiments, the system has a seal disposed at a distal region of the access tool and adapted to seal against an interior cervical os. The seal may be, e.g., an expandable member, such as a balloon. The balloon may have a distal sealing portion adapted to preferentially expand prior to a proximal indicator portion when the balloon is expanded with fluid. 
     Some embodiments of the system also have an expansion mechanism adapted to contact tissue within the uterus to move uterine tissue away from the opening in the access tool lumen. Such a system may also have an advancement mechanism operatively connected to the expansion mechanism to move the expansion mechanism distally with respect to the access tool. 
     Some embodiments may also provide a vapor delivery tool adapted to be inserted through the access tool lumen. 
     Still another aspect of the invention provides a method of providing heat therapy to a patient&#39;s uterus. In some embodiments the method includes the steps of: inserting an access tool through a cervix and a cervical canal into the uterus; placing an expansion mechanism in contact with tissue within the uterus to move uterine tissue surfaces away from an opening in an access tool lumen; delivering vapor through the vapor delivery tool into the uterus; and condensing the vapor on tissue within the uterus. 
     In some embodiments, the method includes the step of advancing the expansion mechanism distally prior to the placing step. In some embodiments the expansion mechanism may be advanced to place a distal portion of the advancement mechanism adjacent a fallopian os prior to delivering vapor, and in some embodiments advancement of the expansion mechanism will cease before a distal portion of the advancement mechanism reaches a fallopian os and prior to delivery of vapor. Advancement of the expansion mechanism may be performed by moving an expansion mechanism actuator on the access tool. 
     In some embodiments the expansion mechanism may have two expansion arms, in which case the placing step may include the step of moving the expansion arms apart. In some embodiments distal portions of the expansion arms together form an obturator tip prior to the step of moving the expansion arms apart. 
     Some embodiments of the invention include the step of sealing an interior cervical os after the inserting step. In some embodiments, the step of delivering vapor includes the step of inserting a vapor delivery tool through the access tool lumen. 
     Yet another aspect of the invention provides a uterine heat therapy system including: an access tool adapted to be inserted through a human cervical canal to place an opening of an access tool lumen within a uterus when the access tool is inserted through the cervical canal; an expansion mechanism adapted to be advanced into the uterus to move uterine tissue surfaces away from the opening in the access tool lumen; and a vapor delivery mechanism adapted to deliver condensable vapor through the access tool to the uterus, the condensable vapor being adapted to condense within the uterus. 
     In some embodiments, the expansion mechanism, when fully advanced, is adapted to extend beyond the opening of the access tool lumen less than a distance from an interior cervical os of the uterus to a fallopian tube os of the uterus. In other embodiments the expansion mechanism, when fully advanced, is adapted to extend beyond the opening of the access tool lumen substantially all a distance from an interior cervical os of the uterus to a fallopian tube os of the uterus. 
     In some embodiments, the access tool includes an expansion mechanism actuator operatively connected to the expansion tool to expand the expansion tool. The expansion mechanism actuator may also be further adapted to advance the expansion mechanism distally beyond the opening of the access tool lumen. 
     In some embodiments, the expansion mechanism includes two expansion arms adapted to move apart as the expansion mechanism is advanced beyond the opening of the access tool lumen. In some of these embodiments, distal portions of the expansion arms together form an obturator tip prior to moving the expansion arms apart. In addition, each of the distal portions of the expansion arms is sized to substantially occlude a fallopian os of the uterus. 
     Some embodiments also include a seal disposed at a distal region of the access tool and adapted to seal against an interior cervical os. Some embodiments of the system also include a vapor delivery tool adapted to be inserted through the access tool lumen. 
     Still another aspect of the invention provides a method of providing heat therapy to a patient&#39;s uterus including the following steps: inserting an access tool through a cervix and a cervical canal into the uterus; after inserting the access tool into the uterus, inserting a vapor delivery tool through an access tool lumen; delivering vapor through the vapor delivery tool into the uterus; and condensing the vapor on tissue within the uterus. 
     Some embodiments of the invention also include the step of connecting the vapor delivery tool to a vapor source prior to the step of inserting the vapor delivery tool through the access tool lumen. In some of those embodiments, the method also includes the step of passing vapor from the vapor source through at least a portion of the vapor delivery tool to an exhaust port exterior the patient prior to delivering vapor to the uterus. In embodiments in which the vapor delivery tool has a vapor delivery actuator operatively connected to the vapor source, the method may further include the step actuating the vapor delivery actuator prior to the step of delivering vapor. 
     In some embodiments, the delivering step includes the step of delivering vapor through a plurality of exit ports in the vapor delivery tool, such as through an exit port disposed at a distal tip of the vapor delivery tool and through an exit port on a longitudinal portion of the vapor delivery tool. The delivering step may also further include the step of moving a movable member disposed within a vapor delivery tool lumen adjacent at least one exit port to alter vapor flow through the at least one exit port. 
     Some embodiments of the invention include the step of exhausting vapor and/or vapor condensate from the uterus, such as through a vapor exhaust channel disposed radially outward from a vapor delivery channel; through a vapor exhaust channel disposed between an exterior surface of the vapor delivery tool and an interior surface of the access tool; and/or through a vapor exhaust channel disposed in the vapor delivery tool. The method may also include the step of sealing an interior cervical os after the inserting step. 
     In some embodiments, the method includes the step of placing an expansion mechanism in contact with tissue within the uterus to move uterine tissue away from an opening in the lumen prior to the delivering step. The method may also include the step of advancing the expansion mechanism distally with respect to the access tool lumen prior to the placing step. 
     Another aspect of the invention provides a uterine heat therapy system including: an access tool, the access tool being adapted to be inserted through a human cervical canal to place an opening of the access tool lumen within a uterus when the access tool is inserted through the cervical canal; and a vapor delivery mechanism, the vapor delivery mechanism having a vapor delivery tool and a vapor source, the vapor delivery tool being adapted to be inserted through the access tool to deliver condensable vapor from the vapor source to the uterus, the condensable vapor being adapted to condense within the uterus. 
     Some embodiments of the vapor delivery tool have a vapor exit port, in which case the vapor delivery mechanism may further have a vapor delivery tool warming circuit with a vapor flow path from the vapor source to a vapor exhaust without passing through the vapor delivery tool vapor exit port. In such embodiments, the vapor delivery mechanism may also have a vapor delivery tool connector, with the vapor delivery mechanism being configured to deliver vapor through the warming circuit automatically when the vapor delivery tool connector is connected to the vapor source. The vapor delivery mechanism may also have a vapor delivery actuator operatively connected to the vapor delivery tool and the vapor source to control delivery of vapor from the vapor source to a vapor delivery tool exit port and to direct vapor through the vapor delivery tool warming circuit. 
     Some embodiments of the vapor delivery tool have a plurality of vapor exit ports. In some of such embodiments, none of the vapor exit ports is at a distal tip of the vapor delivery tool. In some such embodiments, the plurality of exit ports include one or more exit ports on a longitudinal portion of the vapor delivery tool proximal to a distal tip of the vapor delivery tool. The vapor delivery tool may also include a movable member disposed within a vapor delivery tool lumen adjacent at least one exit port, the movable member being adapted to alter vapor flow through the at least one exit port in response to vapor flow through the vapor delivery tool. 
     In some embodiments, the vapor delivery tool has a vapor delivery channel, with the uterine heat therapy system further including a vapor exhaust channel adapted to exhaust vapor and/or condensed vapor from the uterus. The vapor delivery channel may be disposed radially inward from the vapor exhaust channel. In some embodiments, the vapor exhaust channel may be disposed between an exterior surface of the vapor delivery tool and an interior surface of the access tool. In some embodiments, the vapor exhaust channel may be disposed in the vapor delivery tool. 
     In some embodiments, the vapor delivery tool has an exit port at a distal end of a vapor delivery channel and an atraumatic tip disposed distal to the exit port. The vapor delivery tool may also have a flexible support (such as a coil) supporting the atraumatic tip. The flexible support may surround the exit port and may have a vapor passage. 
     In some embodiments, the vapor delivery tool has a vapor exhaust channel disposed radially outward from the vapor delivery channel. The vapor exhaust channel may have an inlet disposed proximal to the vapor delivery channel exit port. 
     Some embodiments of the invention have a seal disposed at a distal region of the access tool and adapted to seal against an interior cervical os. Some embodiments also have an expansion mechanism adapted to contact tissue within the uterus when the opening of the access tool is inserted into the uterus to move uterine tissue away from the opening in the access tool lumen. 
     Still another aspect of the invention provides a method of providing heat therapy to a patient&#39;s uterus, including the following steps: inserting an access tool through a cervix and a cervical canal into the uterus; after inserting the access tool into the uterus, creating a seal between an exterior surface of the access tool and an interior cervical os; providing an indication to a user that the seal has been created; delivering vapor through the access tool lumen into the uterus; and condensing the vapor on tissue within the uterus. 
     In some embodiments, the step of creating a seal comprises expanding an expandable member, such as a balloon. The expanding step may include the step of preferentially expanding a sealing portion of the balloon disposed at the interior cervical os prior to an indicator portion of the balloon disposed proximal to the interior cervical os. The expanding step may also include the step of supplying coolant to the balloon. 
     In some embodiments, the method includes the step of placing an expansion mechanism in contact with tissue within the uterus to move uterine tissue away from an opening in the access tool lumen. Some such embodiments include the step of advancing the expansion mechanism distally with respect to the access tool lumen prior to the placing step. 
     In some embodiments, the step of delivering vapor includes the step of inserting a vapor delivery tool through the access tool lumen. Some embodiments also include the step of exhausting vapor and/or vapor condensate from the uterus. 
     Yet another aspect of the invention provides a uterine heat therapy system having: an access tool with a lumen, the access tool being adapted to be inserted through a human cervical canal to place an opening of the lumen within a uterus when the access tool is inserted through the cervical canal; a seal disposed at a distal region of the access tool and adapted to seal the access tool against an interior cervical os; a sealing indicator adapted to provide a user with an indication that the seal has sealed the access tool with the interior cervical os; and a vapor delivery mechanism adapted to deliver condensable vapor through the access tool to the uterus, the condensable vapor being adapted to condense within the uterus. 
     In some embodiments, the seal includes an expandable member, such as a balloon. In some such embodiments, the balloon has a distal sealing portion adapted to preferentially expand prior to a proximal indicator portion when the balloon is expanded with fluid. 
     Some embodiments also include an expansion mechanism adapted to contact tissue within the uterus to move uterine tissue away from the opening in the access tool lumen. Some such embodiments also include an advancement mechanism operatively connected to the expansion mechanism to move the expansion mechanism distally with respect to the access tool. Some embodiments also include a vapor delivery tool adapted to be inserted through the access tool lumen. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The novel features of the invention are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which: 
         FIG. 1  is a partial cross-sectional drawing showing an embodiment of the invention in place in a uterus. 
         FIGS. 2 and 3  are partial cross-sectional drawings showing the embodiment of  FIG. 1  treating a uterus. 
         FIG. 4  is an elevational view of a vapor delivery tool according to one embodiment of the invention along with a blow-up view of the tip of the vapor delivery tool. 
         FIG. 5  is an elevational view of a distal end of a vapor delivery tool according to another embodiment of the invention. 
         FIG. 6  is an elevational view of a distal end of a vapor delivery tool according to yet another embodiment of the invention. 
         FIG. 7  is an elevational view of a distal end of a vapor delivery tool according to still another embodiment of the invention. 
         FIG. 8A  is an elevational view of a distal end of a vapor delivery tool according to another embodiment of the invention along with a blow-up cross-sectional view. 
         FIG. 8B  is a cross-sectional view of a distal end of a vapor delivery tool according to yet another embodiment of the invention. 
         FIG. 9  is an elevational view of the vapor delivery tool of  FIG. 8A  or  8 B delivering vapor. 
         FIG. 10  is an elevational view of an expansion mechanism of a uterine access tool according to one embodiment of the invention. 
         FIG. 11  is a cross-sectional view along the line A-A of the embodiment of  FIG. 10 . 
         FIG. 12  is another elevational view of the expansion mechanism of  FIG. 10 . 
         FIG. 13  is a cross-sectional view along the line B-B of the embodiment of  FIG. 12 . 
         FIG. 14  is a perspective view of the expansion mechanism of  FIG. 10  emerging from a delivery tool cannula. 
         FIG. 15  is a cross-sectional view of portions of the embodiment of  FIG. 10 . 
         FIG. 16  is a cross-sectional view showing an expansion mechanism loading tool according to one embodiment of the invention. 
         FIGS. 17 and 18  are elevational views of the expansion mechanism loading tool of  FIG. 16  in use. 
         FIG. 19  shows an expansion mechanism loaded into a uterine access tool according to one aspect of the invention. 
         FIG. 20A  shows another embodiment of an expansion mechanism and uterine access tool. 
         FIG. 20B  is a cross-sectional view of portions of the uterine access tool of  FIG. 20A . 
         FIG. 21A  is an elevational view of an obturator of a uterine access tool according to one embodiment of the invention. 
         FIG. 21B  is a cross-sectional view of the obturator of  FIG. 21A . 
         FIG. 22  is an elevational view of portions of a uterine access tool. 
         FIG. 23  is a cross-sectional view of the uterine access tool of  FIG. 22 . 
         FIG. 24  is another elevational view of the access tool of  FIG. 22 . 
         FIG. 25  is a cross-sectional view of the access tool along the line A-A of  FIG. 24 . 
         FIG. 26  is an elevational view of the access tool of  FIG. 22  showing an obturator in place. 
         FIG. 27  is a cross-sectional view along the line B-B of  FIG. 26 . 
         FIG. 28  is a cross-sectional view of a uterine access tool according to an embodiment of the invention. 
         FIG. 29  is a cross-sectional view of a uterine access tool according to an embodiment of the invention. 
         FIG. 30  is a cross-sectional view of a uterine access tool according to an embodiment of the invention along the line B-B of  FIG. 31 . 
         FIG. 31  is a cross-sectional view of a uterine access tool according to the embodiment of  FIG. 30 . 
         FIGS. 32-34  show cross-sectional views of alternative embodiments of uterine access tools. 
         FIGS. 35 and 36  are elevational views of a uterine access tool according to yet another embodiment of the invention. 
         FIG. 37  shows the uterine access tool of  FIGS. 35 and 36  in use with a vapor delivery tool to treat a uterus. 
         FIG. 38  are side and end elevational views of a uterine access tool and a vapor delivery tool according to still another embodiment of the invention. 
         FIG. 39  are side and end elevational views of the uterine access tool and vapor delivery tool of  FIG. 38 . 
         FIG. 40  is an elevational view of a uterine access tool according to yet another embodiment of the invention. 
         FIG. 41  shows still another embodiment of a uterine access tool and vapor delivery tool. 
         FIG. 42  is a cross-sectional view along the line A-A of the embodiment of  FIG. 41 . 
         FIG. 43  is a cross-sectional view along the line B-B of the embodiment of  FIG. 41 . 
         FIG. 44  is a partial view of yet another embodiment of the invention. 
         FIG. 45  is a partial cross-sectional view of the embodiment of  FIG. 44 . 
         FIG. 46  is a perspective view of a uterine access tool and a vapor delivery tool according to still another embodiment of the invention. 
         FIG. 47  is a perspective view of the embodiment of  FIG. 46  with the vapor delivery tool inserted into the uterine access tool. 
         FIG. 48  is a cross-sectional view of the uterine access tool of  FIG. 46 . 
         FIG. 49  is a cross-sectional view of the uterine access tool of  FIG. 46 . 
         FIG. 50  is another cross-sectional view of the uterine access tool of  FIG. 46 . 
         FIG. 51  is a perspective view of a uterine access tool according to another embodiment of the invention. 
         FIG. 52  is a cross-sectional view of the vapor delivery tool of  FIG. 46 . 
         FIG. 53A  is an end elevational view of another uterine access tool embodiment. 
         FIG. 53B  is a cross-sectional view of the uterine access tool of  FIG. 53A . 
         FIG. 54A  is an end elevational view of the uterine access tool of  FIG. 53A  showing the expansion mechanism partially advanced. 
         FIG. 54B  is a cross-sectional view of the uterine access tool of  FIG. 53A  showing the expansion mechanism partially advanced. 
         FIG. 55A  is an end elevational view of the uterine access tool of  FIG. 53A  showing the expansion mechanism fully advanced. 
         FIG. 55B  is a cross-sectional view of the uterine access tool of  FIG. 53A  showing the expansion mechanism fully advanced. 
         FIG. 56  is a perspective and partial cross-sectional view of a uterine therapy system according to yet another embodiment of the invention. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The present invention provides improved methods and apparatus for endometrial ablation using heated vapor. 
       FIGS. 1-45  show embodiments of a system  10  for heating and ablating the endometrium  12  of a uterus  14 . In these embodiments, the system  10  includes a vapor delivery component or tool  16 , a uterus expansion mechanism, such as basket  18 , and an access tool or introducer  20 . As shown in  FIGS. 1-3 , basket  18  and the distal end of the vapor delivery component  16  have been inserted through the cervical os  22  and cervical canal  24  into the lumen or cavity  25  of the uterus. Basket  18  has been expanded after insertion to open up the uterine cavity and to keep tissue away from the vapor outlets of the vapor delivery component. The distal ends  26  and  28  of basket  18  are disposed in the os  30  and  32  of the Fallopian tubes  34  and  36  to orient the device within the cavity and to help seal the Fallopian tube os. The basket struts  56  and  58  conform to any irregularities in the uterine wall as shown in  FIG. 3 . 
     Vapor (such as steam) is produced in a handle portion  38  of vapor delivery component  16  or produced remotely by a vapor generator connected via a conduit, and introduced into the uterine cavity through ports  40  in the distal end of the vapor delivery component. Water may be supplied to handle  40  via water line  44 . The steam within the uterine cavity is shown at  42 . Further details of suitable vapor generation parameters and equipment may be found in US 2004/0068306. 
       FIGS. 6 and 7  show alternative shapes for vapor delivery component ports  40 . In  FIG. 6 , ports  40  are round. In  FIG. 7 , ports  40  are slots. 
       FIGS. 8 and 9  show another alternative design for the distal end of vapor delivery component  16 . In addition to tear-shaped ports  40 , an additional port  46  is formed in the distal tip of vapor delivery component  16 . In the embodiment shown in  FIG. 8A , a ball  48  is held within the distal end of vapor delivery component  16  just proximal to port  46  by a circumferential ridge  50 . As vapor pressure builds within vapor delivery component  16 , divots  49  in ball  48  cause it to rotate within the chamber between port  46  and ridge  50  as the pressure escapes around the partially occlusive sphere, thereby effectively closing and opening access to port  46 . This motion creates puffs of vapor  52  through port  46  when ball  48  is not blocking port  46  and directs more vapor  54  out through side ports  40  when ball  48  is blocking port  46 . In the embodiment shown in  FIG. 8B , the movable component is a spiral wrapped elongated element  51 , also held in place by ridge  50 . By using a floating semi-occlusive element to raise the back-pressure at the tip of the vapor delivery component, the lumen of vapor delivery component  16  may be made larger. A larger size lumen has the advantage of reducing the amount of condensation along the course of the lumen. The amount of resistance is a function of the fit of the semi-occlusive device to the inner lumen, the amount of decrease in the ID at the ridge  50 , and the presence, number and size of any fenestrations proximal to the ridge  50 . 
       FIGS. 10-19  show details of the expansion mechanism and access tool components of a device according to one embodiment of the invention. The expansion mechanism includes a basket  18  which has two deformable arms  56  and  58  made, e.g., out of shape memory material. A two part plastic hub  60  secures the proximal ends of the basket arms and interfaces with the inner diameter of the introducer. The distal hub component  64  has keyed slots that accommodate the distal ends of the wire shafts of the basket component that allow for securing the shafts to the hub assembly locking the shafts into the keyed slots. The proximal hub component is fabricated so that it secures the shaft within the keyed slots of the distal hub component locking them in place as it is glued to the mated portion of the distal component. Lumens  66  and  68  in the first and second parts  62  and  64  of hub  60  provide access for the vapor delivery component. 
       FIGS. 16-20  show how the basket is loaded and delivered. In the embodiment shown in  FIGS. 16-19 , this can be done as is done in other medical device technologies as shown in  FIGS. 17 and 18 , where basket arms  56  and  58  are pulled proximally through a funnel  70  into a capture cylinder  72 , and the funnel  70  is then removed. As the basket arms and capture cylinder are advanced distally through the introducer, an exterior shoulder  74  on cylinder engages a stop  92  (shown in  FIG. 31 ) formed on the interior of the introducer just proximal to the distal end of the introducer, guides the advancement of the basket arms  56  and  58  continue to move distally. This permits arms  56  and  58  to exit the capture cylinder and expand into the uterine cavity. In the embodiment shown in  FIGS. 20A  and B, a metal collar  71  with a tapered inner surface  73  serves to guide the basket arms into the capture cylinder. The metal collar  71  may thereafter be left in place or removed. 
       FIGS. 21-37  show further details of the access tool or introducer. Access tool  20  has a central lumen  76  extending from an inlet  78  through a shaft  80 . As shown in the cross-sectional view of  FIG. 25 , lumen  76  may be non-radially symmetrical in cross-section and may be formed with alignment features, such as ridges  82 . The cross-sectional shape of lumen  76  and the alignment features  82  can help orient the basket arms  56  and  58  and the vapor delivery component  20  within the lumen, as shown in  FIG. 28 . The lumen&#39;s cross-sectional shape and alignment features may also help orient and hold an obturator  84  within the lumen  76 , as shown in  FIG. 27 , which is placed during the introduction of the introducer at the time of the initial insertion of the device into the uterine cavity, prior to the insertion of the hysteroscope prior to the introduction of the vapor delivery component. The obturator serves to seal the distal end of the introducer as it passes through the cervix into the body of the uterus. The shaft  80  may be formed with a non-circular outer cross-sectional shape, as shown in  FIG. 29 , to help the user orient the device to the plane of the uterus and to decrease the outer diameter along one axis of the shaft. 
     In some embodiments it may be important to minimize heat transfer to the cervical canal. As shown in  FIGS. 28 and 29 , the shaft of the vapor delivery component  16  is held away from the walls of the introducer by the basket arms  56  and  58  and by the alignment features  82 . In some embodiments, the introducer shaft provides additional heat protection through active cooling by circulating cooling fluid around the outside of the vapor delivery component. For example, cooling fluid (such as saline) may be introduced through an inlet port  86  at the inlet of the introducer and into lumens  88  and  90  extending through the introducer shaft  80 , as shown in  FIGS. 30 and 31 . Lumens  88  and  90  terminate proximal to the distal end of introducer shaft  80 . Cooling fluid flowing out of the distal ends of lumens  88  and  90  is pushed proximally by the pressure of the vapor within the uterine cavity and flows proximally within lumen  76  around the exterior of vapor delivery component  16  and the basket arms (not shown in  FIG. 31 ). 
     The interior introducer shaft  80  may be provided with ridges or spokes  92  to hold the vapor delivery component  16  in the center and to provide space for the basket arms  56  and  58 , as shown in  FIGS. 32-34 . In these embodiments, introducer shaft  80  may be formed from a polyamide. 
       FIGS. 35-37  show an embodiment with an additional or alternative active cooling feature. A cooling jacket  94  is disposed around the outside of the introducer shaft. After insertion of the introducer, basket arms and the vapor delivery component into the uterus, cooling fluid may introduced into cooling jacket  94  through an inlet  96 . This additional cooling will help maintain the temperature of the cervical canal within a safe range. An optional additional feature is a sealing balloon  98  around the outside of the introducer proximal to its distal end. Balloon  98  may be inflated with fluid from an inlet port  100  to seal the uterine cavity prior to introduction of vapor through vapor delivery component, as shown in  FIG. 37 . 
       FIGS. 38 and 39  show an embodiment in which the sealing balloon  98  is fashioned so that in the inflated state it distends beyond the distal end of the introducer shaft or cannula  80  and (as in  FIG. 39 ) seals around the vapor delivery component  16  to occlude the fluid cooling channels of the cannula  80 . 
     In  FIG. 40 , an outer water jacket  101  (e.g., a balloon or compressible conduit, such as a PET PTCA balloon with an inner delivery component versus a guide lumen as in a PTCA balloon) wraps around delivery cannula  80 . Jacket  101  surrounds the introducer in one continuous sheath or, alternatively, wraps around the introducer component spiraling from the proximal end, where the coolant inlet  96  is connected to a pressurized cold water supply. Coolant communicates with a small fenestration  102  at the distal end of the introducer that allows the coolant to leave the jacket  101  and enter the central lumen of the introducer, then travel back down the inside of the introducer lumen. When combined with the occluding distal balloon  98 , this active cooling arrangement creates a circuit where there is continuous coolant flow from the outer compressible conduit to the inner cooling chamber. The flow is a function of the inlet pressure of the coolant and the size of the fenestration in the introducer that provides resistance to the pressurized coolant before allowing it to flow into the central chamber. The coolant source can be, e.g., a transfusion pressure bag or an IV bag as used in blood transfusions. The coolant pressurizes the outer conduit so that it inflates over the tissue interface, thereby separating the tissues being protected from the thermal source with a flowing coolant component. 
     An alternative active cooling arrangement is to have the return of the coolant travel within a second compressible spiraling conduit running along side of the first conduit like a candy cane where one helical stripe flows in one direction proximal to distal and the other helical stripe flows distal to proximal. These conduits communicate at the distal end to complete the return path rerouting the coolant back down the shaft on the outside of the shaft instead of via the inner lumen. There could also be a temperature feedback mechanism within the conduit so that flow can be increased in response to a rise in temperature. 
       FIGS. 41-42  show an embodiment in which the vapor delivery component  16  has an inner lumen  108  surrounded by an outer, sealed lumen  104 . Inner lumen  108  is held away from the walls of outer lumen  104  by spacers  106 . A vacuum may be formed in outer lumen  108  to insulate the inner lumen. 
       FIG. 43  shows an embodiment in which the delivery cannula  80  has a plurality of longitudinal spokes or spacers  110  projecting radially inward and holding the vapor delivery component  16  (or other device) centered within the lumen. Coolant may flow through channels  112 . Spokes  110  may have sharp tips to reduce the mass coming into contact with the hot vapor delivery component. The remainder of each spoke serves as a heat exchanger to transfer heat from the spoke tip to the coolant. 
       FIGS. 44 and 45  show a modification to the  FIG. 43  embodiment in which the spokes  110  are scalloped to further reduce the points of contact between the vapor delivery component  16  and the delivery cannula material. The scalloping also increases the contact between the flowing coolant and the hot vapor delivery component. 
       FIGS. 46-52  show yet another embodiment of a uterine heat therapy system  200 . The main components of system  200  are a uterine access tool  202 , a vapor probe  204  and a vapor source or generator (not shown). Access tool  202  has a handle  206  with an access cannula  208  extending distally from the distal end  207  of the handle  206 . A sealing balloon  210  surrounds the distal portion of the cannula  208  and extends proximally to an indicator balloon segment  212 . The distal end  201  of cannula  208  may be blunt or rounded to serve as an obturator during insertion of the access tool into a patient&#39;s uterus. 
     In this embodiment, the distal portion  213  of the balloon has a uniform diameter, and an optional intermediate stepped portion  214  is formed in the balloon. In alternative embodiments, the stepped portion may be eliminated, and/or an increased diameter balloon portion may be formed at the distal end of the balloon. In addition, the indicator portion may optionally be a separate member in alternative embodiments. The balloon  210  is shown in its inflated state in  FIGS. 46 and 47 . During insertion into the uterus, the balloon will be in a flattened or deflated state to lower the access tool&#39;s insertion profile. 
     As in earlier embodiments, access tool  202  has an expansion mechanism for moving uterine tissue apart and away from the tool. In this embodiment, the expansion mechanism has two flexible arms  216  and  218  formed, e.g., from shape memory material. Arms  216  and  218  are integral with or connected to wires or rods extending proximally through access tool  202  along or within cannula  208  to an actuator  220  on handle  206 . In this embodiment, the wires extending proximally from arms  216  and  218  are disposed in lumens  217  and  219  formed in cannula  208 . The lumens  217  and  219  are shown in  FIGS. 49 and 50 , which omit the wires for clarity. 
     Actuator  220  may be operated to advance or withdraw arms  216  and  218 , which are shown in their advanced state in  FIGS. 47 and 48 . In this advanced stated within a uterus, arms  216  and  218  move uterine tissue away from the distal end of access tool  202 . Unlike earlier embodiments, however, arms  216  and  218  extend only partway up the uterine wall and do not reach or occlude either fallopian tube os. When withdrawn, arms  216  and  218  collapse and are pulled into a chamber  203  formed in the distal portion of cannula  208 . 
     As shown in more detail in  FIGS. 48-50 , cannula  208  has a plurality of lumens. A central access lumen  222  communicates at its proximal end with a port  224  in a Tuohy-Borst clamp  226 . At its distal end, lumen  222  extends to the distal end of the cannula and into the uterus when the access tool is placed in the uterus. A port at the distal end of lumen  222  and in the proximal portion of chamber  203  is disposed between the arms  216  and  218  of the expansion mechanism. 
     A plurality of inlet and outlet ports are formed in handle  206 . A coolant inlet port  228  connects to a coolant inlet line  230 ; a coolant outlet port  232  connects to a coolant outlet line  234 ; a saline flush inlet port  236  connects to a saline inlet line  238 ; and a saline outlet port  240  connects to a saline outlet line  242 . In this embodiment, the inlet and outlet lines combine into an optional single flexible hose  244 . Hose  244  connects to sources of coolant and saline flush solution (not shown) via a connector  246 . 
     As shown in  FIGS. 48-50 , coolant entering handle  206  through port  228  enters cannula lumen  250  via an opening  248  formed in the proximal end of cannula  208  within handle  206 . A port  252  formed in a distal portion of lumen  250  allows coolant to exit the lumen and enter the interior of balloon  210 . The pressurized coolant flows proximally within balloon  210  and enters a return lumen  254  through a port  256  located within the indicator portion  212  of the balloon. The returning coolant exits lumen  254  via an opening  258  in the handle and then enters coolant return line  234  through port  232 . This flow path is shown by arrows in  FIG. 48 . 
     In a similar manner, pressurized saline may be introduced through inlet line  238  and port  236  which communicates with lumen  222  via an opening (not shown) within handle  206  so that the uterus can be flushed with saline. Returning saline from the uterus enters a lumen  260  in cannula  208 , then flows back through an opening (not shown) within handle  206 , then through port  240  into return line  242 . 
     Cannula  208  may be formed with optional longitudinal grooves  262  to provide a return flow path for the coolant through the balloon, even if the patient&#39;s anatomy does not permit the balloon to inflate in any substantial way. 
       FIG. 51  shows an optional mesh or net  264  covering at least a distal portion of balloon  210  to constrain expansion of that portion of the balloon. Also in  FIG. 51 , the expansion mechanism actuator  220  has been moved to draw the expansion arms into the distal end of the access tool. 
     Vapor probe  204  connects to a vapor source (not shown), such as a boiler or other steam generator, via an insulated flexible hose  270  and connector  246 . A vapor delivery cannula  272  extending from a handle  273  has a central vapor delivery lumen  274  and a concentric annular vapor return lumen  276  surrounding lumen  274 , as shown in  FIG. 52 . When inserted through port  224  into lumen  222  of the access cannula  208 , the distal end  280  of vapor delivery cannula  272  extends beyond the distal end of cannula  208  to a position between expansion arms  216  and  218  when the arms are in their advanced position, as shown in  FIG. 47 . 
     When connected to a vapor source, vapor flows through a vapor supply lumen (not shown) in hose  270  into handle  273  through a lumen  282  into a chamber  284 . When valve  286  is in its closed position, all vapor entering chamber  284  flows through a lumen  288  back into a vapor exhaust lumen (not shown) in hose  270  to a vapor and/or condensate collection vessel (not shown). This flow of vapor within the handle portion of the vapor probe provides a warming circuit for the vapor probe to help ensure that the vapor quality will be maintained at its appropriate level when the valve is opened and vapor is delivered to the patient. 
     When valve  286  is opened, at least a portion of the vapor flows through valve  286  into lumen  274  of vapor cannula  272  and out the distal end of the vapor cannula for providing uterine heat therapy. Returning vapor and/or condensate flows proximally through annular lumen  276  into a vapor return lumen  290  in handle  273 , then through an opening  292  into lumen  288  and the vapor exhaust lumen in hose  270 . Vapor flow is shown by arrows in  FIG. 52 . 
     In one embodiment, only a portion of the vapor supplied to chamber  284  of the vapor probe flows into vapor delivery cannula  272  when valve  286  is open. In this embodiment, most of the vapor returns through lumen  288  to hose  270 . Vapor flowing in lumen  288  past the opening  292  of vapor return lumen provides a venturi action that helps pull the exhaust vapor and any condensate through lumen  290  and annular lumen  276 . 
     A thermocouple (not shown) may be disposed at the distal end of the vapor delivery cannula  272  and connected to a monitor or controller (not shown) to monitor intrauterine temperature and provide a signal to a vapor delivery controller for controlling the therapy. 
     When using the system of the invention to provide uterine heat therapy to a patient to treat, e.g., endometriosis, access to the uterus is obtained by inserting a speculum into the patient&#39;s vagina and grasping the cervix with a tenaculum. The tenaculum pulls the cervix forward while the speculum pushes down on the patient&#39;s peritoneum to straighten the uterine canal and align it with the vaginal canal. If desired, a hysteroscope may be inserted through port  224  of the access tool with the distal end of the hysteroscope at the level of the obturator tip  201  of the access tool, and the Tuohy-Borst seal may be tightened around the hysteroscope. The access tool cannula may then be lubricated and inserted through the cervix. The flexibility of the access tool (including the flexible cannula  208  and flexible expansion arms  216  and  218 ) permits insertion with a minimum of straightening of the cervical canal. In addition, the blunt obturator tip  201  of the access cannula  208  helps minimize the likelihood of perforation as the access tool is advanced. 
     Once the distal end of the access cannula  208  has passed through the internal cervical os into the uterine cavity, the hysteroscope can be used to confirm placement. The hysteroscope may be advanced beyond the distal end of the access cannula  208 , if desired. After confirming position of the access cannula, the expansion arms  216  and  218  are advanced by pushing actuator  220  forward. This action engages arms  216  and  218  with the uterine wall tissue to move the tissue away from the distal end of the vapor probe. 
     The coolant balloon  210  may then be inflated by providing pressurized coolant through the coolant inlet, as described above. Balloon  210  expands to seal the cervical canal up to the internal cervical os. As the balloon engages the cervical canal wall, coolant pressure will continue to rise up toward the coolant inlet pressure. When the pressure of coolant within the balloon reaches an indicator pressure, the indicator portion  212  of the balloon will expand to provide an indication to the user that the distal portion of the balloon has engaged the wall of the cervical canal to seal the opening. If a hysteroscope was used, it can now be removed. 
     The vapor delivery cannula  272  of vapor probe  204  is then inserted through port  224  until the distal tip  280  extends through the distal end of the access cannula  208 , as shown in  FIG. 47 . Hose  270  may be connected to the vapor source prior to or while the access tool is being inserted into the patient so that the warming circuit can warm the vapor probe handle and internal components. When ready to deliver therapy to the patient, valve  286  is opened to permit vapor to flow through vapor delivery cannula  272  into the patient&#39;s uterus. 
     In one embodiment, a thermocouple disposed at the distal end of the vapor delivery cannula monitors intrauterine temperature. The thermocouple provides a temperature signal to a vapor delivery controller to initiate a timed sequence once the uterine cavity reaches a threshold temperature, such as 50° C. The controller discontinues vapor flow after the predetermined time. 
     After completion of the vapor therapy, the expansion arms are retracted and coolant flow is stopped. After the indicator balloon segment deflates, the access tool and vapor delivery probe may be removed from the patient. 
     In some embodiments of the method, a saline flush may be provided prior to the procedure and/or at the end of the procedure. As described above, saline may be provided through lumen  222  around the hysteroscope or vapor delivery probe. Delivering saline at the end of the procedure may be desirable to release any vacuum formed in the uterus due to condensation of vapor. 
     Vapor may be delivered to the uterus at an intrauterine pressure of 5 to 35 mm Hg. Coolant pressure within the sealing balloon may be 50 to 300 mm Hg. Typical therapy time for treating endometrial tissue may range from 15 sec. to 120 sec., with a preferred duration of 45-60 sec. 
       FIGS. 53-55  show another embodiment of the uterine heat therapy system of this invention. In this embodiment, the distal end of an expansion mechanism  302  extends beyond the distal end of a uterine access tool cannula  304 . Expansion mechanism  302  has two blunt distal ends  306  and  308  each of which has a proximally facing shoulder  310  and  312 , respectively. Shoulders  310  and  312  rest on the distal end  316  of cannula  304  when the expansion mechanism is in its undeployed position, as shown in  FIG. 53B . 
     A central fenestration channel is formed by the cooperation of two half channels  318  and  320  formed on cooperating interior surfaces  319  and  321  of expansion mechanism ends  306  and  308  to provide an opening through the expansion mechanism, even in its undeployed position, to permit access through the expansion mechanism by a hysteroscope or probe  322  as shown in  FIG. 53A . The channel may be used to permit visualization by a hysteroscope during advancement of the access tool into the uterus. 
     Actuation wires or rods  324  extend proximally from the distal ends of the expansion mechanism through an interior lumen  326  of the cannula to an actuator (not shown). Other lumens  328  may be formed in cannula  304  for coolant flow, saline flush, etc. as described in earlier embodiments. 
     When the expansion mechanism is actuated, the distal ends  306  and  308  move distally. As the ends  306  and  308  move distally, camming surface  330  on distal end  306  and camming surface  332  on distal end  308  slide against the hysteroscope (or other inserted component)  322 , and camming surface  334  on distal end  306  and camming surface  336  on distal end  308  slide against the distal end of cannula  304  to cause the distal ends  306  and  308  to move apart, thereby engaging and moving uterine tissue away from the distal end of the inserted tool  322 , as shown in  FIG. 54 . Further distal advancement of the expansion mechanism causes the distal ends  306  and  308  to move further apart due to a pre-bent shape of the wires or rods  324 , as shown in  FIG. 55 . 
       FIG. 56  shows aspects of a uterine therapy system  400  according to yet another embodiment of the invention. In this embodiment, the distal end  408  of the vapor delivery probe  412  extends beyond the distal end  404  of the uterine access tool cannula  402 . During therapy, vapor is delivered from the distal end of the vapor delivery probe  412 , and vapor and/or condensate is returned through the annular space in the cannula surrounding the vapor delivery probe. 
     An atraumatic tip  414  is supported distal to the distal end of the vapor delivery probe by a coil  410 . Coil  410  may be attached to the probe  412  by, e.g. welding. During vapor delivery, vapor will pass through adjacent windings of coil  410  to reach uterine tissue.