APPLICATOR FOR INSERTION INTO A BODY OPENING FOR MEDICAL PURPOSES

Abstract: An applicator for insertion into a body opening for med­ ical treatment or for diagnostic purposes comprises an el­ ongated jacket (2) for insertion into the body opening a dis­ posable sleeve (6) received on the jacket (2), and a balloon (7) integrally formed on the disposable sleeve (6) at one side of the jacket (2). The balloon (7) is inflatable by a fluid to press the opposite side of the jacket (2) and sleeve (6) laterally against the tissue of the body opening, thereby to fix the posi­ tion of the jacket (2) within the body opening and to conform the pressed body tissue to the shape of the opposite side of the jacket (2).

Description: The present invention concerns an application for insertion into a body opening for hyperthermic treatment of tumors according to the precharacterizing portion of claim 1. The invention is particularly useful as a heating applicator for insertion through the anus into the rectum of a patient for use in hyperthermia treatments, and is therefore described below with respect to this application. The applicator of the present invention is particularly useful with the catheter and probe described in EP-A-0 246 176. Hyperthermia is a recognized technique for rendering certain therapeutic treatments to a patient by the application of heat to the portion of the patient's body to be treated. A large number of applicators have been developed for treating cancer, or for other therapeutic purposes such as the treatment of hemorrhoids, as described for example in US-A-4,375,220, 4,312,364, 4,311,154, 4,227,535, 4,186,729, 4,154,246, 4,140,130, 4,016,886, 2,043,083, 2,032,859 and 1,433,286. European patent 0 139 607, corresponding to US patent 4 601 296 discloses another applicator of this type for insertion into a body opening for medical purposes, which applicator includes an elongated jacket for insertion into the body opening, and a flexible sleeve surrounding the jacket. In the construction described in this patent, the flexible sleeve is inflatable with a coolant to fill the cavity according to the anatomical configuration of the cavity and of the tumour being treated. An object of the present invention is to provide an applicator of the latter type but having advantages over the construction described in that patent. According to the present invention, there is provided an applicator of the type described in European patent 0 139 607, characterized according to the characterizing portion of claim 1. The invention is particularly useful for rendering hyperthermia treatments. For such an application, the applicator further includes a microwave antenna disposed within the jacket, the jacket further including cooling ducts adjacent its outer surface for circulating a cooling fluid therethrough in order to prevent undue heating of the body tissue in direct contact therewith. The balloon, when inflated, thereby also effects efficient cooling of the body tissue in contact with the opposite side of the jacket. The applicator may thus be used for heating tissue directly in contact with the outer face of the applicator, in which case a cooling fluid would not be circulated through the cooling ducts; alternatively, the applicator may be used for heating more remotely-located tissue, in which case a cooling fluid would be circulated through the cooling ducts in order to prevent undue heating of the tissue in direct contact with the applicator. The invention is herein described, by way of example only, with reference to the accompanying drawings, wherein: Fig. 1 is a side elevational view illustrating one form of heating applicator constructed in accordance with the present invention, the sleeve and balloon carried by the applicator being shown in its inflated condition; Fig. 2 is a longitudinal sectional view of the applicator of Fig. 1 with the heating element and balloon-sleeve removed; Fig. 3 is a transverse sectional view along lines III--III of Fig. 1; Fig. 4 is a diagrammatic view illustrating the formation of the channels in the outer face of the inner sleeve, which channels cooperate with the outer sleeve of the jacket to define the cooling ducts; Fig. 5 is an end view, partly in section, of the end fitting in the applicator of Fig. 1; Figs. 5a, 5b and 5c are sectional views along lines a--a, b--b, c--c, respectively, of Fig. 5; and Fig. 6 is a sectional view of the microwave antenna used as the heating element in the applicator of Fig. 1. The applicator illustrated in the drawings comprises an elongated jacket, generally designated 2, for insertion into a body cavity at the location of the tissue to be heated. The applicator illustrated in Fig. 1 is particularly designed for insertion via the body anus into the rectum for treating this region of the body, although it will be appreciated that the invention could be applied to other body cavities and used for other therapeutic treatments or for diagnostic purposes. The illustrated applicator includes a heating element in the form of a microwave antenna, indicated by broken lines 4 in Fig. 1 but more particularly illustrated in Fig. 6, generating RF electromagnetic radiation for heating the body tissue. The applicator further includes a disposable sleeve 6, carried by the jacket 2 and integrably formed with a balloon 7 projecting laterally at the distal end of the sleeve. Balloon 7 is inflatable by air or water applied via a tubelet 8 extending through an end fitting 10 externally of the sleeve. The balloon 7 is of generally conical configuration when inflated, having a narrow tip 7a joined to the sleeve 6, and a wide base 7b at its opposite end engageable with the body tissue at one side of the body opening when the balloon is inflated while the applicator is within the body opening. Antenna 4 is more particularly illustrated in Fig. 6. It is constructed of a coaxial cable including an inner electrical conductor 12 and an outer electrical conductor braid 13 separated from the inner conductor by a dielectric layer 14. The dielectric layer 14 is removed from the end of the coaxial cable to bare the inner conductor 12, and the inner conductor is then covered by a dielectric layer 15, e.g. glass or ceramic having a dielectric constant of at least 2. The outer conductor braid at the end of the cable is folded back over itself and is separated from the underlying braid by a dielectric layer 16. The outer face of the antenna is then covered by a protective coating 18, as by dipping in a bath of insulating material. As shown more particularly in Figs. 2 and 3, jacket 2 includes an inner, relatively thick core 20, an outer thin sleeve 22, and a solid tip 24 at the distal end of the applicator. Inner core 20 is formed with an axially-extending bore 26 for receiving the microwave antenna 4, and its outer face is formed with a plurality of axially-extending ribs 20a to define a plurality of recessed channels 28, as more particularly illustrated in Figs. 3 and 4. Channels 28 form, with the outer sleeve 22, a plurality of cooling ducts for circulating a cooling fluid, such as water. As shown in Fig. 4, the cooling ducts defined by recessed channels 28 extend the complete length of the jacket in a sinuous manner from the cooling fluid inlet 30 at the proximal end of the applicator (left end in Fig. 4, but right end in Figs. 1 and 2) back and forth with respect to the opposite, distal end of the applicator, the water exiting via the water outlet 32 at the proximal end of the applicator. The solid tip 24 at the distal end of the applicator is formed with an annular recess 34 for receiving the distal ends of the inner core 20 and the outer sleeve 22. The proximal ends of these sleeves are received within a cylindrical recess 36 formed centrally of the end fitting 10. End fitting 10 is further formed with a central bore 40 for passing the microwave heating antenna 4 therethrough into the bore 26 of the inner core 20. Fitting 10 is further formed with a pair of lateral bores 42, 44 (Figs. 5, 5a) communicating with the cooling ducts 28 for circulating the cooling fluid, (e.g., water) therethrough. Bore 42 is the inlet for the cooling water, and bore 44 is the outlet. End fitting 10 is formed with a further bore 46 (Fig. 5, 5b) serving as the inlet for admitting air or water to inflate balloon 7 via tubelet 8 received within bore 46 and connected to the balloon. End fitting 10 includes a still further bore 48 (Figs. 5, 5c) for receiving the electrical leads of three thermocouples 50a, 50b, 50c (Fig. 1) which measure the temgerature within the body opening into which the applicator has been inserted. The inner core 20 is formed, for approximately one-half its circumference, with the ribs 20a defining the cooling ducts 28; for the other half of its circumference, the outer face of sleeve 22 is lined with a copper reflector layer 52, as shown in Fig. 3, extending substantially along the complete length of the sleeve, this being at the side of the jacket carrying the inflatable balloon 7. Copper layer 52 reflects the electromagnetic radiation generated by the microwave antenna 4 in the direction away from balloon 7 so that the generated heat is concentrated in the body tissue at the side of the body opening opposite to the balloon. Thermocouples 50a, 50b, 50c (Fig. 1) are disposed substantially at the outer surface of jacket 2 adjacent to its distal end, and are spaced from each other a slight distance longitudinally of the jacket, as shown in Fig. 1, in order to measure the temperature at these three selected regions of the body cavity in which the applicator is inserted. The electrical conductors to these thermocouples pass axially along the side of the jacket occupied by reflector 52, on the outer face of the reflector as shown at 54a in Fig. 3, to the axial location of the respective thermocouple, and then pass circumferentially along the outer face of the reflector to their respective thermocouple, as shown at 54b in Fig. 3. Reflector 52 thus substantially shields the electrical conductors from the electromagnetic field produced by the antenna. An insulating layer 56 is applied to insulate electrical conductors 54a, 54b from the reflector 52, and also to insulate the thermocouples 50a-50c from the cooling effect produced by the cooling fluid circulated through the cooling ducts 28. An outer thin protective layer, such as a dipped coating, is applied to the outer face of jacket 2 covering the thermocouples 50a-50c and their electrical conductors 54a, 54b. The disposable sleeve 6, including the balloon 7 and tubelet 8, is supplied separately and may be applied to the outer face of the applicator 2 just before it is intended to be used. Sleeve 6 is preferably formed integrally with balloon 7 from an elastomer, e.g., rubber latex. For sanitary purposes, the sleeve is disposable for one-time use. The manner of using the heating applicator illustrated in the drawings will be apparent from the above description. Thus, after a sleeve 6, with its integrally formed balloon 7 has been applied to the applicator, the applicator is inserted into the body opening, for example into the rectum via the anus, while balloon 7 is deflated. When the distal end (left end) of the applicator is in proper position within the body opening, balloon 7 is inflated by pressurized air or water applied via bore 46 in end fitting 10, and tubelet 8. The inflation of the balloon causes it to firmly press the opposite side of the applicator against the body tissue in the opening. Electrical current is then applied to the microwave antenna 4 in order to generate a microwave field for heating the body tissue opposite to balloon 7, this energy being concentrated by reflector 52. During the heating of the body tissue, water may be circulated via the cooling ducts 28 to cool the outer surface of the jacket, while the temperature within the body opening is measured by thermocouples 50a, 50b, 50c. It will thus be seen that the inflation of balloon 7 at the distal end of the applicator displaces the applicator laterally within the body opening, thereby firmly pressing the side thereof through which the microwave radiation is transmitted (namely the side opposite to that occupied by balloon 7 and reflector 52) firmly against the body tissue. This fixes the position of the jacket, and thereby of the microwave antenna 4, within the body opening, and also conforms the pressed body tissues to the shape of the jacket at the opposite side of reflector 52. The inflation of balloon 7 also enhances the cooling effect produced by the water circulated through the cooling ducts 28, thereby efficiently cooling the body tissue in direct contact with the applicator. This permits the application of relatively large amounts of heat to relatively remote tissue without undue discomfort to the subject, or heat damage to the adjacent tissue lining the body cavity receiving the applicator. If, however, it is desired to heat the adjacent tissue lining the body cavity received the applicator, the cooling water would not be circulated through the cooling ducts 28. The described applicator may therefore be used for heating relatively remote tissue, in which case cooling water would be circulated through cooling ducts, or adjacent tissue, e.g., tissue, lining the cavity receiving the applicator, in which case there would be no circulation of cooling fluid through the cooling ducts. The provision of the thermocouples 50a-50c adjacent to the outer face of the jacket but thermally insulated from the cooling ducts 28, and the provision of the balloon pressing the thermocouples against the body tissue, produce a more precise measurement of the temperature of the body tissue being heated by the applicator. Moreover, by passing the electrical conductors to the thermocouples axially along the outer face of reflector 52 (conductor sections 54a, Fig. 3) and then circumferentially (conductor sections 54b, Fig. 3) to their respective thermocouples 50a-50c, the measurements produced by the thermocouples are substantially insensitive to the heat and electromagnetic field produced by the microwave antenna, thereby further increasing the precision of the temperature measurements of the body tissue.

Claims: 1. An applicator for insertion into a body opening for hyperthermic treatment of tumours which applicator includes a probe having an elongated jacket (2) and a sleeve (6) received on the distal end of said jacket (2) to be inserted into the body in the vicinity of a tumour to be treated, the probe comprising an integrally formed housing having cavities wherein are disposed a forward heating portion containing a radio emitting antenna (4) producing an overall directional radiation pattern and a conduit system (8,28) for the passage of a cooling fluid adjacent the outer surface thereof for cooling of the tissue lying adjacent the probe and a rearward portion being arranged to be of significantly less cross sectional area than the forward portion, the probe also including temperature sensing means for indicating the temperature at the surface of the probe and automatic temperature control means for control operation of the automatic response thereto and to terminate operation of the antenna in response of overheating of the adjacent tissue, the sleeve (6) being partly inflatable by a fluid to press the opposite side of the jacket (2) and sleeve (6) facing away from its inflatable part (7) laterally against the tissue of the body opening, thereby to fix the position of the jacket (2) within the body opening and to conform the pressed body tissue to the shape of said opposite side of the jacket (2) and sleeve (6) characterized in that said flexible sleeve (6) includes a balloon (7) integrally formed with and joined to the flexible sleeve (6) at one side of the sleeve and jacket, said balloon occupying only the distal end of said flexible sleeve (6) and said balloon (7) is of generally conical configuration when inflated having a narrow tip (7a) at one end where joined to said sleeve and a wide base (7b) at the opposite end for engagement with the body tissue at said opposite side of the jacket (2), said jacket (2) including an inner relatively core (20), a sleeve (22) and a tip (24), said inner core being formed for approximately one-half its circumference with ribs (20a) defining cooling ducts (28) and for the other half of its circumference, the outer face of sleeve (22) is lined with a copper reflector layer (52) extending substantially along the complete length of the sleeve, at the side of the jacket carrying the inflatable balloon (7). 2. The applicator according to claim 1, characterized in further including a tubelet (8) extending externally of said flexible sleeve (6) to said balloon (7) for inflating and deflating same. 3. The applicator according to any one of claims 1 and 2 characterized in further including a microwave antenna (4) disposed within said jacket (2), said cooling ducts (28) within said jacket (2) adjacent its outer surface circulating a cooling fluid therethrough in order to prevent undue heating of the body tissue in direct contact therewith, said balloon (7), when inflated, thereby also effecting efficient cooling of the body tissue in contact with said opposite side of the jacket. 4. The applicator according to claim 3, characterized in that said reflector (52) within said jacket at said one side reflects the microwave energy produced by said microwave antenna (4) through said opposite side, and for concentrating the energy to a selected region of the body tissue at said opposite side of the jacket (2). 5. The applicator according to claim 4, characterized in that said microwave antenna (4) includes an inner electrical conductor (12), a layer of dielectric thereover (14), serving as a dielectric loading, and an outer electrical conductor (13) in the form of a braid; the outer end of said outer electrical braid (13) being folded back over itself at one end of the antenna and being dielectrically separate from the underlying electrical braid by another dielectric layer (16), thereby forming a dielectric loaded antenna in which the folded back portion of the electrical braid serves as an RF choke supressing electromagnetic interference. 6. The applicator according to any one of claims 1-5, characterized in that said jacket (2) further includes a temperature measuring device (50a-50c) adjacent to the outer surface of said opposite side of the jacket (2), said balloon (7), when inflated, thereby also effecting efficient measurment of the temperature of the body tissue in contact with said opposite side of the jacket. 7. The applicator according to claim 6, characterized in that said temperature device (50a-50c) includes an electrical conductor having a first section (54a) passing axially of the jacket (2) and reflector (52) along the face of the reflector opposite to that facing the RF heating element so as to be substantially shielded therefrom by the reflector, and a second section (54b) passing circumferentially of the jacket (2) from its first section (54a) shielded by the reflector (52) to the temperature measuring device (50a, 50b, 50c). 8. The applicator according to either of claims 6 or 7 characterized in that there are a plurality of said temperature measuring devices (50a, 50b, 50c) spaced axially of said jacket (2), each of said temperature measuring devices being a thermocouple attached to the outer face of the jacket (2) and thermally insulated therefrom.

Inventors: ESHEL, UZI, LEV, AVIGDOR
Applicants: BIODAN MEDICAL SYSTEMS LTD
Application year: 1987
Main classification: A61M23
IPC codes: A61B18, A61F7, A61M31, A61N5, A61M23