JP5618828B2 - Method and kit for administering brachytherapy to a subject - Google Patents

Description

  The present invention relates to the field of subject brachytherapy. More particularly, the present invention relates to a brachytherapy catheter that can vary in stiffness depending on the stage of treatment.

  Catheter brachytherapy provides a subject with internal radiation therapy by advancing the radioactive source along a catheter whose tip is inserted near the treatment area. It is commonly used for the treatment of esophageal and uterine cancers and head and neck cancers. Catheter brachytherapy is known in the art. Clinical studies have shown that brachytherapy is an effective treatment that reduces the size and growth rate of cancer, both in palliative care and in radical indications.

  Depending on the indication in esophageal cancer, etc., catheter brachytherapy is used by a skilled practitioner to introduce a guide wire to the subject using a visualization device such as an endoscope to ensure an accurate route and position of the guide wire. I need that. Once the guide wire is positioned, the catheter is introduced using the guide wire and positioned appropriately within the subject. Subsequently, the radiation source attached to the end of the source wire is advanced through the catheter so that the radiation source can reach the treatment site and deliver an effective radiation dose. After radiation treatment, remove the radiation source. The catheter is removed because it cannot remain in place for subsequent treatment. This insertion procedure must be repeated again for each treatment session.

  This particular procedure is highly traumatic for the subject, as it takes some time to position the catheter and some time to avoid infection when making an incision. When treating esophageal cancer, the catheter is passed through the oral cavity and throat, but usually it has a large diameter, which causes suffocation and / or severe discomfort due to nausea. Usually subjects must be sedated. In addition, the catheter must remain in place throughout the treatment, and the patient continues to feel pain throughout. Furthermore, brachytherapy may have to be performed in divided portions, i.e. repeated multiple times in subsequent visits, and this divided treatment is more effective and less toxic. This means that this painful treatment must be performed on the patient multiple times. Because there is a limit that the patient can tolerate, the fractional treatment must be limited and can only be considered to improve the treatment site after external radiation therapy. There is a need to develop a method of brachytherapy that is less traumatic for the patient and easier to use.

  The present invention provides a novel method and kit for performing catheter brachytherapy that overcomes the problems of patient discomfort and stress during treatment and facilitates split therapy.

One embodiment of the present invention is a kit for administering catheter brachytherapy to a subject,
A medical balloon catheter 1 having a proximal end 2 and a distal end 3, an elongated catheter tube 5 with an inflation lumen 21 extending therein, and an inflation lumen 21 of the catheter tube 5 towards the distal end 3 At least one inflatable balloon 4, 4 ′ in fluid communication with the inflation lumen 21 for inflating fluid to the at least one inflatable balloon 4, 4 ′ in the presence of the removable inner tube 6. A medical balloon catheter 1 configured to carry;
A removable inner tube 6 having an elongated body, an opening 9 proximal end 7, a closure 10 distal end 8, and a source wire lumen 22 extending therein,
The removable inner tube 6 is configured to be inserted and removed from at least a portion of the length of the inflation lumen 21;
The source wire lumen 22 is configured to house a source wire 19 carrying a therapeutic radiation source 20;
A removable inner tube 6;
A kit for administering brachytherapy to a subject.

Another embodiment of the invention is a kit for administering brachytherapy to a subject comprising:
A medical balloon catheter 1 having a proximal end 2 and a distal end 3, an elongated catheter tube 5 with an inflation lumen 21 extending therein, and an inflation lumen 21 of the catheter tube 5 towards the distal end 3 At least one inflatable balloon 4, 4 ′ in fluid communication with the catheter tube 5, which is configured to extend from the kink state and slidably accommodates the inner tube 6 from which the inflation lumen 21 can be removed. A medical balloon catheter 1 configured to carry inflation fluid to at least one inflatable balloon 4, 4 ′ in the presence of a removable inner tube 6;
A removable inner tube 6 having an elongated body, an opening 9 proximal end 7, a closure 10 distal end 8, and a source wire lumen 22 extending therein,
The removable inner tube 6 is configured to be inserted and removed from at least part of the length of the inflation lumen 21;
The source wire lumen 22 is configured to house a source wire 19 carrying a therapeutic radiation source 20;
A removable inner tube 6;
A kit for administering brachytherapy to a subject.

Another embodiment of the invention is a kit for administering brachytherapy to a subject comprising:
A medical balloon catheter 1 having a proximal end 2 and a distal end 3, an elongated catheter tube 5 with an inflation lumen 21 extending therein, and an inflation lumen 21 of the catheter tube 5 towards the distal end 3 At least one inflatable balloon 4, 4 ′ in fluid communication with the catheter tube 5, and the inflation lumen 21 comprises:
-Containing the removable inner tube 6; and-configured to carry inflation fluid to the at least one inflatable balloon 4, 4 'in the presence of the removable inner tube 6.
A medical balloon catheter 1;
A removable inner tube 6 having an elongated body, an opening 9 proximal end 7, a closure 10 distal end 8, and a source wire lumen 22 extending therein,
The removable inner tube 6 is configured to be inserted and removed from at least part of the length of the inflation lumen 21;
The source wire lumen 22 is configured to house a source wire 19 carrying a therapeutic radiation source 20;
A removable inner tube 6;
A kit for administering brachytherapy to a subject.

  Another embodiment of the present invention allows the balloon 4 to be inflated, and the opening 9 proximal end 7 of the removable inner tube 6 when the removable inner tube 6 is inserted into the inflation lumen 21 when inflated. The kit as described above, further comprising an expansion joint 12 configured to couple the proximal end of the catheter tube 5 to an expansion pump to allow access to the tube.

Another embodiment of the present invention is:
The expansion joint 12 is
A distal port 14 in which a distal seal 16 is disposed;
A proximal port 13 in which a proximal seal 15 is disposed;
A pump coupling 17 operatively connected to the valve;
The ports 13, 14 and the pump coupling 17 are fluidly connected to the chamber 27 of the coupling 12,
The distal port 14 is configured to receive the proximal end of the catheter tube 5 and form a seal against the body of the catheter tube 5;
The proximal port 13 is configured to receive the removable inner tube 6 and form a seal against the body of the removable inner tube 6 distal to the opening 9; A kit as described above that allows the proximal end to pass through the fitting 12.

  Another embodiment of the present invention is a kit as described above, wherein the outer diameter of the catheter tube 5 is 2-6 mm.

  Another embodiment of the present invention is a kit as described above, wherein the catheter tube 5 has a bending stiffness that is lower than the bending stiffness of the removable inner tube 6.

  Another embodiment of the present invention is a kit as described above, wherein the catheter tube 5 is made from silicone rubber or polyurethane.

  Another embodiment of the present invention is a kit as described above, wherein the catheter tube 5 is made from polyurethane or a polyurethane-containing compound.

  Another embodiment of the present invention is a kit as described above, wherein the diameter of the inflation lumen 21 is 5% to 20% greater than the outer diameter of the removable inner tube 6.

  Another embodiment of the present invention is as described above, wherein a non-extensible cord is disposed between the proximal end 2 and the distal end 3 of the catheter tube 5 to prevent longitudinal extension of the medical catheter 1. It is a kit.

  Another embodiment of the present invention is a kit as described above, wherein the cord is placed inside, outside or inside the wall of the catheter tube 5.

  Another embodiment of the present invention is a kit as described above, wherein the proximal end of the catheter tube 5 is reinforced to reduce deformation by applying circumferential pressure.

In another embodiment of the present invention, the reinforcement is
An outer tube arranged on the proximal end of the catheter tube 5;
An inner tube inserted into the proximal end of the catheter tube 5 or an extension to the proximal end of the catheter tube 5;
Is a kit as described above.

  Another embodiment of the present invention is a kit as described above, wherein the medical catheter 1 comprises a visible scale marked along at least part of the length of the catheter tube 5.

  Another embodiment of the present invention is a kit as described above, wherein the wall of the removable inner tube 6 has a thickness of 0.1 mm to 0.4 mm.

  Another embodiment of the present invention is a kit as described above, wherein the removable inner tube 6 has a higher bending stiffness than the catheter tube 5.

  Another embodiment of the present invention is a kit as described above, wherein the proximal end of the removable inner tube 6 is reinforced to reduce deformation by applying circumferential pressure.

In another embodiment of the present invention, the reinforcement is
A reinforced outer tube 48 arranged on the proximal end or on the removable inner tube 6 towards the proximal end,
A reinforced inner tube 49 inserted into the removable inner tube 6 at or towards the proximal end, or a reinforced extension 50 to the proximal end of the removable inner tube 6;
Is a kit as described above.

  In another embodiment of the present invention, the reinforced outer tube 48 disposed on the removable inner tube 6 has an annular ridge 51 disposed at or toward the proximal end of the reinforced tube 48. A kit as described above.

  Another embodiment of the present invention is a kit as described above, wherein the removable inner tube 6 comprises a visible scale marked along at least part of its length.

  Another embodiment of the present invention is a kit as described above, wherein the removable inner tube 6 has a bending stiffness that is 1% to 60% higher than the bending stiffness of the catheter tube 5.

  Another embodiment of the present invention is a kit as described above, wherein the removable inner tube 6 is made of polypropylene, polytetrafluoroethylene (PTFE), PEEK (polyetheretherketone) or polyethylene.

  Another embodiment of the present invention is a kit as described above, wherein the removable inner tube 6 is made of polyimide, PEEK (polyetheretherketone) or polyethylene.

  Another embodiment of the present invention is a kit as described above, wherein the diameter of the source wire lumen 22 of the removable inner tube 6 is between 0.5 mm and 1.9 mm.

  Another embodiment of the present invention is a kit as described above, wherein the removable inner tube 6 is 3 cm to 90 cm longer than the medical balloon catheter 1.

  Another embodiment of the present invention is a removable pusher configured to be inserted into and removed from the inflation lumen 21 to provide rigidity to the catheter tube 5 upon insertion into a subject via the nasopharyngeal route. The kit as described above, further comprising a wire 11.

  Another embodiment of the present invention is a kit as described above, wherein the pusher wire 11 has a higher bending stiffness than the removable inner tube 6.

  Another embodiment of the present invention is a kit as described above further comprising an expansion pump 30.

  Another embodiment of the present invention is a kit as described above, wherein a medical balloon catheter is configured to be inserted into the esophagus via the nasopharyngeal route.

  Another embodiment of the present invention is a kit as described above, wherein a medical balloon catheter is configured to be inserted into the uterine cavity via the cervical route.

  Another embodiment of the present invention is a kit as described above, wherein a medical balloon catheter is configured to be inserted into breast tissue via a breast incision or needle puncture.

Another embodiment of the present invention is a method of administering catheter brachytherapy to a subject comprising:
Inserting a contracted medical balloon catheter 1 into the subject's esophagus via a nasopharyngeal route, the medical balloon catheter 1 having a proximal end 2 and a distal end 3, and an inflation lumen; An inflatable lumen 21 comprising an elongate catheter tube 5 with 20 extending therein and at least one inflatable balloon 4, 4 ′ in fluid communication with the inflation lumen 21 of the catheter tube 5 toward the distal end 3. Inserting a deflated medical balloon catheter 1 configured to carry inflation fluid to at least one inflatable balloon 4, 4 ′ in the presence of a removable inner tube 6;
Positioning at least one inflatable balloon 4, 4 ′ in the treatment area;
Inserting a removable inner tube 6 into the inflation lumen 21, which extends into the elongated body, the opening 9 proximal end 7, the closure 10 distal end 8, and the interior; A source wire lumen 22,
The removable inner tube 6 is configured to be inserted and removed from at least a portion of the length of the inflation lumen 21;
The source wire lumen 22 is configured to house a source wire 19 carrying a therapeutic radiation source 20;
Inserting a removable inner tube 6,
-Inflating at least one inflatable balloon 4, 4 ';
Advancing the source wire 19 through the source wire lumen 22 to the treatment area to administer a fixed dose of radiation;
-Removing the radiation source wire 19;
-Deflating at least one inflatable balloon 4, 4 ';
-Removing the removable inner tube 6; and optionally leaving the medical balloon catheter 1 in place for subsequent treatment sessions;
A method of performing catheter brachytherapy on a subject.

Another embodiment of the present invention is a method of administering catheter brachytherapy to a subject comprising:
Inserting a medical balloon catheter 1 through an entry point in a subject, the medical balloon catheter 1 having a proximal end 2 and a distal end 3 with an inflating lumen 20 extending therein; The catheter tube 5 and at least one inflatable balloon 4, 4 ′ in fluid communication with the inflation lumen 21 of the catheter tube 5 toward the distal end 3, so that the catheter tube 5 extends from the kink state. Configured and allows the inflatable lumen 21 to slidably house the removable inner tube 6, the inflatable lumen 21 in the presence of the removable inner tube 6 being at least one inflatable balloon 4, 4. Inserting a medical balloon catheter 1 configured to carry an inflation fluid into
Positioning at least one inflatable balloon 4, 4 ′ in the treatment area;
Inserting a removable inner tube 6 into the inflation lumen 21, which extends into the elongated body, the opening 9 proximal end 7, the closure 10 distal end 8, and the interior; A source wire lumen 22,
The removable inner tube 6 is configured to be inserted and removed from at least a portion of the length of the inflation lumen 21;
The source wire lumen 22 is configured to house a source wire 19 carrying a therapeutic radiation source 20;
Inserting a removable inner tube 6,
-Inflating at least one inflatable balloon 4, 4 ';
Advancing the source wire 19 through the source wire lumen 22 to the treatment area to administer a fixed dose of radiation;
-Removing the radiation source wire 19;
-Deflating at least one inflatable balloon 4, 4 ';
-Removing the removable inner tube 6; and optionally leaving the medical balloon catheter 1 in place for subsequent treatment sessions;
A method of performing catheter brachytherapy on a subject.

Another embodiment of the present invention is a method of administering catheter brachytherapy to a subject comprising:
Inserting a medical balloon catheter 1 through an entry point in a subject, the medical balloon catheter 1 having a proximal end 2 and a distal end 3 with an inflating lumen 20 extending therein; The catheter tube 5 and at least one inflatable balloon 4, 4 ′ in fluid communication with the inflation lumen 21 of the catheter tube 5 towards the distal end 3, the catheter tube 5 being kinkable, the inflation lumen 21
-Containing the removable inner tube 6; and-configured to carry inflation fluid to the at least one inflatable balloon 4, 4 'in the presence of the removable inner tube 6.
Inserting a medical balloon catheter 1;
Positioning at least one inflatable balloon 4, 4 ′ in the treatment area;
Inserting a removable inner tube 6 into the inflation lumen 21, which extends into the elongated body, the opening 9 proximal end 7, the closure 10 distal end 8, and the interior; The removable inner tube 6 has a source wire lumen 22 and is not kinkable,
The removable inner tube 6 is configured to be inserted and removed from at least a portion of the length of the inflation lumen 21;
The source wire lumen 22 is configured to house a source wire 19 carrying a therapeutic radiation source 20;
Inserting a removable inner tube 6,
-Inflating at least one inflatable balloon 4, 4 ';
Advancing the source wire 19 through the source wire lumen 22 to the treatment area to administer a fixed dose of radiation;
-Removing the radiation source wire 19;
-Deflating at least one inflatable balloon 4, 4 ';
-Removing the removable inner tube 6; and optionally leaving the medical balloon catheter 1 in place for subsequent treatment sessions;
A method of performing catheter brachytherapy on a subject.

  Another embodiment of the present invention is described above, wherein the pusher wire 11 is inserted into the inflation lumen 21 before the medical balloon catheter 1 is advanced in the body to provide temporary stiffness to the medical balloon catheter 1. It is a method like this.

  Another embodiment of the present invention provides for inflation as described above after insertion of the medical balloon catheter 1 into the subject's esophagus via the nasopharyngeal route and before insertion of the removable inner tube 6 into the inflation lumen 21. In the manner as described above, the joint 12 is coupled to the catheter tubing 5 at the proximal end 2 of the catheter 1.

  Another embodiment of the invention is as described above, wherein the expansion joint 12 is further coupled to the proximal end 7 of the removable inner tube 6 after insertion of the removable inner tube 6 into the expansion lumen 21. Is the method.

  Another embodiment of the present invention is a method as described above, wherein the expansion joint 12 is removed from the medical balloon catheter 1 after removal of the removable inner tube 6.

  Another embodiment of the present invention is a method as described above, wherein the proximal portion of the medical balloon catheter 1 is secured to the patient's body with a plaster after insertion into the body and / or between treatment sessions.

  Another embodiment of the present invention is a method as described above, wherein the treatment is divided.

  Another embodiment of the present invention is a method as described above, wherein the medical balloon catheter 1 is left in place for 3 to 21 days.

  Another embodiment of the present invention is a method as described above, wherein the medical balloon catheter 1 is inserted into the subject's esophagus via the nasopharyngeal route to administer brachytherapy to the esophagus.

  Another embodiment of the present invention is a method as described above, wherein the proximal portion of the medical balloon catheter 1 is secured with a bandage to the patient's nose after insertion via the nasopharyngeal route and / or between treatment sessions. It is.

  Another embodiment of the present invention is a method as described above, wherein a medical balloon catheter 1 is inserted into a subject's uterine cavity via the cervical route to provide brachytherapy to the uterine cavity. is there.

  Another embodiment of the present invention is as described above, wherein the proximal portion of the medical balloon catheter 1 is secured with a suture to the cervical outlet after insertion via the cervical pathway and / or between treatment sessions. It is a simple method.

  Another embodiment of the present invention is a method as described above, wherein a medical balloon catheter 1 is inserted into a subject's breast tissue via a breast incision to administer brachytherapy to the breast. is there.

  Another embodiment of the present invention is a method as described above, wherein the proximal portion of the medical balloon catheter 1 is secured with a bandage at a location that exits the breast after insertion via an incision and / or between treatment sessions. It is.

  Another embodiment of the present invention is a method as described above, using a kit as described above.

FIG. 4 shows a cross-sectional view of a medical balloon catheter comprising an elongate lumen and an elongate catheter tube having two inflatable balloons in fluid communication with the inflation lumen. FIG. 6 shows a cross-sectional view of a removable inner tube having an elongated body, an open proximal end, a closed distal end, and a source wire lumen extending therein. FIG. 6 shows a schematic diagram of a pusher wire configured to be inserted and removed from an inflation lumen to provide rigidity to the catheter tube upon insertion into a subject via a nasopharyngeal route. FIG. 9 shows a view of a pusher wire inserted into the inflation lumen of an elongated catheter tube. FIG. 6 shows a view of a removable inner tube inserted into the inflation lumen of an elongated catheter tube. FIG. 7 shows a cross-sectional view of an expansion joint configured to couple the proximal end of a catheter tube to an expansion pump to allow balloon inflation. FIG. 7 shows a cross section of an expansion joint attached to the proximal end of a catheter tube that seals the expansion lumen while allowing access to the open end of the removable inner tube. A pump is attached to the expansion joint. The balloon is inflated. FIG. 6 shows a cross-sectional view of an expansion joint attached to the proximal end of a catheter tube and a source wire inserted into a source wire lumen of a removable inner tube. The balloon is inflated. FIG. 4 shows a cross-sectional view of an expansion joint with a threaded joint disposed in the port. Fig. 4 shows a cross-sectional view of the proximal end of the elongated catheter tube 5 in which a reinforced outer tube is arranged. Fig. 4 shows a cross-sectional view of the proximal end of the elongated catheter tube 5 in which a reinforced inner tube is arranged. Figure 3 shows a cross-sectional view of the proximal end of an elongated catheter tube 5 that is extended with a stiffening tube. FIG. 6 shows a cross-sectional view of the proximal end of the removable inner tube with a reinforced outer tube disposed thereon. FIG. 4 shows a cross-sectional view of the proximal end of the removable inner tube with a reinforced inner tube disposed thereon. FIG. 6 shows a cross-sectional view of the proximal end of the removable inner tube, extended with a stiffening tube. FIG. 3 shows a cross-sectional view of the proximal end of a removable inner tube in which a reinforced outer tube having an annular ridge is disposed.

  Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. All publications referenced herein are hereby incorporated by reference. The entirety of all US patents and patent applications referred to herein, including the drawings, are hereby incorporated by reference.

  The articles “a” and “an” are used herein to refer to one or more, ie at least one, grammatical objects of the article. By way of example, “alumen” means one lumen or more than one lumen.

  The recitation of numerical ranges by endpoints includes all integers and, where appropriate, the fractions encompassed within the range (eg, 1 to 5 is 1, 2, 3, 4 for example referring to the number of lumens) For example, when referring to measurements, it may also include 1.5, 2, 2.75, and 3.80). The end point description also includes the end point value itself (eg, 1.0-5.0 includes both 1.0 and 5.0).

  The present invention relates to kits and methods for administering catheter brachytherapy to a subject, particularly for split (multiple dose) treatment. This is suitable for the treatment of internal cancer, especially esophageal cancer, uterine cancer, or breast cancer, which is sensitive to catheter brachytherapy. This is particularly suitable for intracavitary or intra-tissue brachytherapy. The present invention introduces a very flexible tube through a therapeutic entry point such as the nose (esophageal cancer), vagina (uterine cancer), or skin puncture or incision (breast cancer), during the radiation treatment period It is based on temporarily strengthening and stiffening the tube, and then returning the tube to its normal flexibility that provides a comfortable fit between radiation therapy sessions. The flexibility of the tube is such that it can be kinked without damage (ie kinkable) or exhibits low pushability, so it provides little or no resistance to bending, so the tube can be It can be worn comfortably after treatment and between treatments, for example it can be taped to the skin. The flexible tube is also provided with an inflatable balloon, which allows the tube to occupy an internal space such as the esophagus or uterus, or to create a space in breast tissue or the like. Importantly, the present invention allows the flexible tube to be strengthened and stiffened by temporarily introducing a stiffer inner tube into the lumen of the flexible tube, Includes a separate lumen for insertion of the radioactive source wire. This configuration provides a dry source wire lumen for the effective administration of radiation therapy, maintains an even dose of radiation to the treatment area, and provides high patient comfort.

1 and 2, one embodiment of the present invention is a kit for administering catheter brachytherapy to a subject,
A medical balloon catheter 1 having a proximal end 2 and a distal end 3, an elongated catheter tube 5 with an inflation lumen 21 extending therein, and an inflation lumen 21 of the catheter tube 5 towards the distal end 3 At least one inflatable balloon 4, 4 ′ in fluid communication with the inflation lumen 21 for inflating fluid to the at least one inflatable balloon 4, 4 ′ in the presence of the removable inner tube 6. A medical balloon catheter 1 configured to carry;
A removable inner tube 6 having an elongated body, an opening 9 proximal end 7, a closure 10 distal end 8, and a source wire lumen 22 extending therein,
The removable inner tube 6 is configured to be inserted and removed from at least a portion of the length of the inflation lumen 21;
The source wire lumen 22 is configured to house a source wire 19 carrying a therapeutic radiation source 20;
A removable inner tube 6;
Comprising a catheter brachytherapy for a subject.

Another embodiment of the invention is a method of administering brachytherapy to the esophagus, comprising:
Inserting a contracted medical balloon catheter 1 into the subject's esophagus via a nasopharyngeal route, the medical balloon catheter 1 having a proximal end 2 and a distal end 3, and an inflation lumen; An inflatable lumen 21 comprising an elongate catheter tube 5 with 20 extending therein and at least one inflatable balloon 4, 4 ′ in fluid communication with the inflation lumen 21 of the catheter tube 5 toward the distal end 3. Inserting a deflated medical balloon catheter 1 configured to carry inflation fluid to at least one inflatable balloon 4, 4 ′ in the presence of a removable inner tube 6;
Positioning at least one inflatable balloon 4, 4 ′ in the treatment area;
Inserting the removable inner tube 6 into the inflation lumen 21 (FIG. 5), the removable inner tube 6 having an elongated body, an opening 9 proximal end 7, a closure 10 distal end 8, and Having a source wire lumen 22 extending therein;
The removable inner tube 6 is configured to be inserted and removed from at least a portion of the length of the inflation lumen 21;
The source wire lumen 22 is configured to house a source wire 19 carrying a therapeutic radiation source 20;
Inserting a removable inner tube 6,
Inflating at least one inflatable balloon 4, 4 ′ (FIG. 7);
Advance the radiation source wire 19 through the source wire lumen 22 to the treatment area and administer a constant radiation dose (FIG. 8);
-Removing the radiation source wire 19;
-Deflating at least one inflatable balloon 4, 4 ';
-Removing the removable inner tube 6; and optionally leaving the medical balloon catheter 1 in place for subsequent treatment sessions;
Including brachytherapy, including brachytherapy.

  The kits and methods described herein allow initiating esophageal brachytherapy via the nasopharyngeal route. The medical balloon catheter has a flexible main body as will be described later, and even a non-professional can insert it into the esophagus via the nasopharyngeal route. It is known in the art that insertion of a feeding tube is a technique that can be performed by a nurse without additional training, usually when feeding a subject after oral surgery. . Thus, a catheter of the present invention using the same path and having similar flexibility can be inserted by a non-specialist such as a nurse using the same technique. This is an improvement over the prior art where the kit and method must be utilized by a trained gastroenterologist and which requires the use of an endoscope and guidewire to insert a large applicator. It is. By allowing non-professionals to perform most of the treatment, the present invention saves the time and cost of treatment of the gastroenterologist. In addition to this benefit, the patient experience is also improved. That is, the treatment can be withstood without sedation and the catheter is worn separately over a long period without discomfort.

Another embodiment of the present invention is a method of applying brachytherapy to the inner wall of the uterus, comprising:
-Inserting the contracted medical balloon catheter 1 into the subject's uterus via the cervical route, the medical balloon catheter 1 having a proximal end 2 and a distal end 3 and an inflation lumen 20 Comprises an elongated catheter tube 5 extending inwardly and at least one inflatable balloon 4, 4 ′ in fluid communication with the inflation lumen 21 of the catheter tube 5 toward the distal end 3. Inserting a deflated medical balloon catheter 1 configured to carry inflation fluid to at least one inflatable balloon 4, 4 ′ in the presence of a removable inner tube 6;
Positioning at least one inflatable balloon 4, 4 ′ in the treatment area;
Inserting the removable inner tube 6 into the inflation lumen 21 (FIG. 5), the removable inner tube 6 having an elongated body, an opening 9 proximal end 7, a closure 10 distal end 8, and Having a source wire lumen 22 extending therein;
The removable inner tube 6 is configured to be inserted and removed from at least a portion of the length of the inflation lumen 21;
The source wire lumen 22 is configured to house a source wire 19 carrying a therapeutic radiation source 20;
Inserting a removable inner tube 6,
Inflating at least one inflatable balloon 4, 4 ′ (FIG. 7);
Advance the radiation source wire 19 through the source wire lumen 22 to the treatment area and administer a constant radiation dose (FIG. 8);
-Removing the radiation source wire 19;
-Deflating at least one inflatable balloon 4, 4 ';
-Removing the removable inner tube 6; and optionally leaving the medical balloon catheter 1 in place for subsequent treatment sessions;
A method of performing brachytherapy on the inner wall of the uterus.

  The medical balloon catheter has a flexible main body as described later, and can be inserted into the uterus via the cervix by a non-specialist. It is known in the art that the insertion of a hysterometer into the uterine cavity is a technique that a radiation oncologist can perform without additional training. Thus, a catheter of the present invention using the same path and having similar flexibility can be inserted by a non-specialist such as a radiation oncologist using the same technique. This is an improvement over the prior art where the kit and method must be utilized by a trained gynecologist and which requires the insertion of a large applicator. By allowing non-professionals to perform most of the treatment, the present invention saves gynecologist time and treatment costs. In addition to this benefit, the patient experience is also improved. That is, this approach allows for split treatment and the catheters are worn separately over a long period without discomfort.

Another embodiment of the present invention is a method of administering brachytherapy to a mastectomy cavity, comprising:
Inserting a contracted medical balloon catheter 1 into a subject's mastectomy cavity after removal of the breast tumor (eg breast-conserving surgery), the medical balloon catheter 1 comprising a proximal end 2 and a distal end And at least one inflatable balloon 4, 4 in fluid communication with the inflation lumen 21 of the catheter tube 5 toward the distal end 3. And the inflation lumen 21 inserts a deflated medical balloon catheter 1 configured to carry inflation fluid to at least one inflatable balloon 4, 4 ′ in the presence of a removable inner tube 6. To do,
Positioning at least one inflatable balloon 4, 4 ′ in the treatment area;
Inserting the removable inner tube 6 into the inflation lumen 21 (FIG. 5), the removable inner tube 6 having an elongated body, an opening 9 proximal end 7, a closure 10 distal end 8, and Having a source wire lumen 22 extending therein;
The removable inner tube 6 is configured to be inserted and removed from at least a portion of the length of the inflation lumen 21;
The source wire lumen 22 is configured to house a source wire 19 carrying a therapeutic radiation source 20;
Inserting a removable inner tube 6,
Inflating at least one inflatable balloon 4, 4 ′ (FIG. 7);
Advance the radiation source wire 19 through the source wire lumen 22 to the treatment area and administer a constant radiation dose (FIG. 8);
-Removing the radiation source wire 19;
-Deflating at least one inflatable balloon 4, 4 ';
-Removing the removable inner tube 6; and optionally leaving the medical balloon catheter 1 in place for subsequent treatment sessions;
A method of performing brachytherapy on a mastectomy cavity.

  The medical balloon catheter can be inserted into the mastectomy cavity via the surgical scar or through the skin. The catheter is worn separately over an extended period without discomfort.

  Since it is possible to easily mount, insert, and remove the device, long-term divided radical treatment is possible. Radiation dose per day (radioactive dose) can be reduced. For example, multiple treatment sessions of 10 to 30 times can be performed with a large interval (for example, one day) between treatments. it can. Split treatment with reduced radiation dose reduces the possibility of scarring (fibrosis and subsequent stenosis) by reducing tissue damage. In the case of esophageal cancer, this can prevent esophageal obstruction due to late fibrosis. In contrast, conventional treatments do not tolerate more than a few (eg, 3-5) treatments due to stress and discomfort in applicator insertion and wearing, so high doses are delivered at each session Must. As a result, esophageal stenosis (due to fibrosis) is common in the prior art.

  Split (multiple, eg 5-30) treatments are more tolerated of the tissue compared to high dose irradiation in 1 to 3 treatments. For example, boost after external radiation therapy (50 Gy) can be given by giving 3 × 5 Gy twice a week, a total dose of 15 Gy, or by giving 20 Gy in 10 sessions. If the patient does not undergo surgery, giving 3 × 5 Gy instead of 10 × 2 Gy increases the risk of fibrosis and stenosis. This means, for example, that the patient must periodically undergo dilatation later to widen the esophageal lumen. This is traumatic and painful.

  Prior art Gerard-Bonboisin probes for esophageal brachytherapy (Nucletron, Veenendael, The Netherlands) may allow one to three treatment sessions, which are semi-conscious under conventional superficial anesthesia Even patients with the condition will feel very severe and traumatic. The much less traumatic system of the present invention allows outpatient fractional treatment that improves the chances of increased dose and improves the cure rate of patients with esophageal cancer. For example, 20 Gy irradiation using split brachytherapy can be performed, which greatly improves the esophageal cancer treatment technique.

  For patients undergoing surgery, adding brachytherapy to chemotherapy and external radiation therapy increases the total eradication of viable cancer cells on the pathological specimen. Many clinical trials dealing with esophageal cancer have shown that only complete responders to radiochemotherapy survive for long periods of time, so to improve the cure rate of esophageal cancer treatment, it is likely that It is necessary to increase the percentage of those who are today from 30% to 50% to 50% to 70%.

  In the case of palliative treatment, easy-to-use fractional brachytherapy is an additional tool in combination with, for example, an esophageal stent, to increase the duration of progression in this highly aggressive disease.

  The terms “distal” and “proximal” are used throughout this specification and generally in the art to mean close to the surgeon side (proximal) or far from the surgeon side (distal). It is a term that is understood. Thus, “proximal” means close to the surgeon side and thus far from the patient side. Conversely, “distal” means close to the patient side and thus far from the surgeon side.

  A medical balloon catheter 1 (FIG. 1) having a proximal end 2 and a distal end 3 includes an elongated catheter tube 5 having an inflation lumen 21 extending therein, and an inflation lumen of the catheter tube 5 toward the distal end 3. At least one inflatable balloon 4, 4 ′ in fluid communication with 21. The distal end of the medical catheter 1 is sealed.

  The medical balloon catheter 1 can be extended at the distal end 3 by a flexible tail formed from an elongated catheter tube 5, which is used for stabilization when the device is used for the treatment of esophageal cancer. Can act as a longitudinal anchor. The tail is fixed to the esophageal wall, thereby reducing the possibility that the medical catheter 1 is released from the subject by coughing or sneezing.

  The size of the medical balloon catheter 1 is thin enough to be introduced through suitable passages such as the nasopharyngeal route, the vaginal route, and the cervical route, or through the skin puncture site. It is flexible enough not to be damaged during kinking and does not have the pushability itself necessary to advance it to the treatment site. These depend on the characteristics of the elongated catheter tube 5 and balloons 4, 4 ', which will be described in detail later.

  The design of the medical balloon catheter 1 advantageously facilitates insertion, removal and mounting using a pusher wire. Upon installation, the proximal end of the catheter tube 5 is fixed to the skin, for example in the case of esophageal treatment, fixed to the nostril using an adhesive strip, in particular a hypoallergenic adhesive strip, around the nostril and / or cheek. Can be kinked. By fixing to the nostril, stable and accurate positioning of the treatment portion of the medical catheter 1 corresponding to the balloon region can be obtained. This fixed portion that is kinked during installation can be stretched or “unkinked” periodically prior to each treatment session to facilitate insertion of the removal inner tube 6 to allow source introduction. Fixation to the skin can be done at the point where the catheter leaves the body, just like any other cancer treatment.

  The medical balloon catheter 1 comprises an elongate catheter tube 5 (FIG. 1) provided with an open proximal end 2 that provides access to an inflation lumen 21 that extends the longitudinal length of the tube. To do. The proximal end provides an opening through which inflation fluid can enter for insertion of the removable inner tube 6 and for insertion of the pusher wire 11.

  The inflation lumen 21 is in fluid communication with at least one inflatable balloon positioned toward the distal end 3 of the catheter tube 5. The inflation lumen 20 can be in fluid communication with at least one inflatable balloon 4, 4 ′ through a plurality of holes 30 in the wall of the catheter tube 5. By applying an inflation fluid, such as saline, through the inflation lumen 21, at least one inflatable balloon 4, 4 'opens and can expand radially to contact the esophageal wall.

  The elongate catheter tube 5 can end in the immediate vicinity of the distal balloon (s), or can extend further in the distal direction of the balloon (s), thereby stabilizing the longitudinal direction relative to the esophageal wall. An extension tail that can serve as an anchor can be provided to the medical balloon catheter 1. The tail reduces the likelihood that the medical catheter 1 will be released from the subject by coughing or sneezing. The distal end of the elongated catheter tube 5 is sealed.

  The diameter of the elongate catheter tube 5 is thin enough to be introduced through suitable passages such as nasopharyngeal, vaginal and cervical routes, or through skin punctures. The elongate catheter tube 5 can be described as being flaccid or kinkable. This is pushability, i.e., from the proximal end of the catheter to advance through the entry point to the treatment site, e.g. through the appropriate passages such as the nasopharyngeal route, vaginal route, and cervical route, or through the skin puncture site. Insufficient ability to transmit force to the distal end. Being kinkable or flexible means that it can be folded at least in half to the extent that it causes, for example, crushing of the tubular wall to produce a fold known as a kink or fold. The kink intersects the longitudinal axis of the elongated catheter tube 5. Since the elongated catheter tube 5 has a kinkable property, the kink is removed without damaging the wall of the elongated catheter tube 5 by extending the tube. More importantly, the insertion of the removable inner tube is hindered by the wall damaged by the kink because it does not affect the integrity and dimensions of the elongated catheter tube 5, in particular the integrity and dimensions of the inflation lumen 21. There is no. Thus, the elongated catheter tube 5 damages the wall of the elongated catheter tube 5 so that the inner tube 6 can be slidably accommodated by the expanded or unkinked inflation lumen 21. It can be folded without That is, the removable inner tube 6 can pass through the position of the kink substantially without hindrance. The elongate catheter tube 5 is sufficiently flexible that it will not be damaged during kinking. This usually provides sufficient flexibility for steering through tortuous paths and sufficient pushability, i.e. sufficient rigidity to give the ability to transmit force from the proximal end to the distal end of the catheter. It deviates from ordinary catheter tubing made from non-kinkable materials. However, such tube materials of the prior art cannot withstand kinks without damaging the tube walls. Furthermore, such prior art catheters are too stiff to be suitable for long-term comfortable wearing. The terms “kinkable” and “non-kinkable” are known in the art.

According to one embodiment of the invention, the flexibility of the tube is described in terms of properties that are relatively easy to measure, such as the cross-sectional diameter of the tube and the elastic modulus (Young) E of one or more materials. If the tube is made of a single material, flexibility can be defined as the reciprocal of the product of the moment of inertia I of the cross section about the bending axis and the Young's modulus E. The product EI is known in the scientific literature as the “bending stiffness” of the beam. For round wire of a single material the moment of inertia I is [pi] d ^4/64, where, d is the outer diameter of the tube. Thus, the bending rigidity becomes EI = πEd ^4/64. This defines the flexibility of the tube at some point. Therefore, it is said that if the EI is doubled, the rigidity of the tube is doubled.

  One end of the tube is fixed and held, and by applying a known weight or force perpendicular to the tube axis at the other end having a uniform cross section, the deflection from the original linear axis is made flexible. Proportional, that is, inversely proportional to the bending stiffness of the tube. The deflection is also proportional to the applied force or weight as well as the cube of the length being tested. Thus, a deflection corresponding to a known load or force required to cause a known deflection can be used as a direct measure of tube flexibility or bending stiffness. Deflection testing is described, for example, in European Patent No. 1666083, which is incorporated herein by reference.

  According to one aspect of the present invention, the bending stiffness in grams of the catheter tube 5 is lower than the bending stiffness of the removable inner tube 6. The bending rigidity of the catheter tube 5 is 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11 than the bending rigidity of the removable inner tube 6. %, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 60%, It may be lower than 70%, 80% or more, or a value between any two of the above values. Preferably, the bending stiffness in grams of the catheter tube 5 is 1% to 60% lower than the bending stiffness of the removable inner tube 6.

  As described above, the catheter tube 5 may not have the pushability necessary to advance through the subject entry point to the treatment site. According to one aspect of the present invention, the pushability of the catheter tube 5 is lower than the pushability of the removable inner tube 6. The removable inner tube 6 is more common in catheter tube materials in the art in that it provides sufficient pushability to advance through the inflation lumen 21 of the catheter tube 5 in this case.

  According to another aspect of the present invention, the catheter tube 5 has shape resilience that allows it to deform upon application of mechanical force (eg, tension, compression) and return to its previous shape upon removal of the force. This property allows the catheter tube 5 to be bent and kinked without damage, and more particularly, to maintain the integrity of the lumen 21 and allow the removable inner tube 6 to pass through substantially without hindrance. In a tube material exhibiting low shape recovery, such as the removable inner tube 6, the source wire lumen 22 is permanently damaged and the free passage of the source wire 19 is prevented or hindered by bending the tube material. Crease kinks occur.

  The catheter tube 5 is made of any suitable material that provides the necessary properties (eg, low / insufficient pushability that is not kinkable) with sufficient strength to withstand inflation pressure and is biocompatible. There is. Suitable materials are known in the art, such as, but not limited to, polyurethane or polyurethane-containing compounds.

  The diameter of the inflation lumen 21 of the catheter tube 5 is configured to accommodate the removable inner tube 6. The diameter of the inflation lumen 21 of the catheter tube 5 is sufficiently larger than the outer diameter of the removable inner tube 6 so that the removable inner tube 6 can be easily advanced and removed from the inflation lumen 21. Should. Generally, the diameter of the inflation lumen 21 is 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10% than the outer diameter of the removable inner tube 6; 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 25%, 30%, 35%, 40%, 45%, or 50% larger.

  According to one aspect of the present invention, the diameter of the inflation lumen 21 is 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2. 0 mm, 2.2 mm, 2.4 mm, 2.6 mm, 2.8 mm, 3.0 mm, 3.2 mm, 3.4 mm, 3.6 mm, 3.8 mm, 4.0 mm, or any two of the above values Between values, preferably 1.4 mm to 2.8 mm.

  According to one aspect of the present invention, the wall of the catheter tube 5 is 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm,. It has a thickness of 9 mm, 1.0 mm, or any two of the above values, preferably 0.1 mm to 0.4 mm.

  According to one aspect of the present invention, the outer diameter of the catheter tube 5 is 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, or a value between any two of the above values, preferably 3 mm to 4 mm.

  According to one aspect of the present invention, the catheter tube 5 is formed from a single tube material from the proximal end 2 to the first proximal balloon 4. According to one aspect of the present invention, the catheter tube 5 is formed from a single piece of tubing from the proximal end 2 to the final distal balloon 4 '.

  According to one aspect of the present invention, the catheter tube 5 is reinforced at the proximal end 2 to prevent or reduce deformation by applying circumferential pressure, such circumferential pressure being provided by an expansion joint described below. Can be added. The catheter tube 5 can be reinforced by increasing the wall thickness at the proximal end, for example by the use of an outer tube of nitinol or polyetheretherketone (PEEK). This embodiment is shown in FIG. 10, where a Nitinol or PEEK tube 45 is attached to the outside of the catheter tube 5 in a coaxial arrangement. Alternatively, the catheter tube 5 can be reinforced by increasing the wall thickness at the proximal end, for example by the use of a Nitinol or PEEK inner tube. This embodiment is illustrated in FIG. 11 where a Nitinol or PEEK tube 46 is inserted into the inflation cavity 21 of the catheter tube 5 in a coaxial arrangement. Alternatively, the catheter tube 5 may be reinforced by an extension tube material joined to the proximal end of the catheter tube by gluing or welding, which may be a braided tube material, nitinol or PEEK tube material, etc. Made of a tube material having a good circumferential compressive strength. This embodiment is shown in FIG. 12, where a Nitinol or PEEK tube 47 is attached to the proximal end of the catheter tube 5. Such extension pieces are commonly used in the art, and adapting the present invention to include such extension pieces is well within the ability of one skilled in the art. The reinforcement facilitates attachment to an expansion joint that seals using circumferential pressure applied to the wall of the catheter tube 5 by preventing distortion of the catheter tube 5. The length of the reinforcing parts 45, 46, 47 can be between 0.5 cm and 5 cm.

  According to one aspect of the present invention, a non-extensible cord is disposed between the proximal end and the distal end of the medical catheter 1 or catheter tube 5, or the cord is particularly removable. The longitudinal extension of the medical catheter 1 or the catheter tube 5 is prevented when the tube 6 is introduced or removed. The cord can be provided inside, outside or inside the wall of the catheter tube 5 and attached to at least the proximal end 2 and the distal end 3 of the medical catheter 1. The cord provides a certain length to the medical catheter 1 upon introduction of the removable inner tube 6 that allows introduction of the radiation source. Preferably, the cord is made from stainless steel, titanium, platinum, nickel, polytetrafluoroethylene (PTFE), PEEK, or other suitable biocompatible material.

  According to one aspect of the present invention, the medical catheter 1 includes a visible scale that is marked along at least a portion of the wall length of the catheter tube 5. The scale may allow the user to specify the length required for insertion of the medical catheter 1 into the nostril edge, for example, so that the balloon 4, 4 'or other distal portion coincides with the area to be treated. . The scale is inserted at a predetermined depth, for example, by allowing subsequent medical catheters 1 to be inserted and properly aligned at the time of divided treatment, thereby reducing the need for a body scanner at subsequent insertions. lose. According to one aspect of the present invention, the scale is in the half of the proximal side 2 of the medical catheter 1. According to another aspect of the invention, the scale is marked in centimeters using a regular numeric display.

  The catheter 1 and removable inner tube 6 utilize a coaxial assembly, but with a separate inflation lumen for inflating the balloon (s), removable inner tube 6, pusher wire 11, and wire. It should be understood that a multi-lumen design can be utilized that provides one or more separate lumens that serve to hold the source wire 19.

  Advantageously, the design of the catheter tube 5 facilitates insertion, removal and mounting. Upon attachment, the proximal end of the catheter tube 5 can be fixed to the nostril using an adhesive strip, in particular a hypoallergenic adhesive strip, and kinked around the nostril and / or cheek. By fixing, a stable positioning of the treatment portion of the medical catheter 1 corresponding to the balloon region can be obtained. This fixed portion may be “unkinked” periodically prior to each treatment session to advance insertion of the removal inner tube 6 to allow source introduction.

  The medical catheter 1 includes one or more (eg, two, three, four, five, six, seven, eight) balloons that are in fluid communication with the inflation lumen 21 of the elongated catheter tube 5. 4, 4 'are provided. One or more balloons 4, 4 ′ (referred to herein as “balloons” unless otherwise indicated) are inflatable to expand radially and contact the wall of the blood vessel or tissue being treated. It is a member. Such balloons are known in the art. In the case of esophageal cancer, the function of the balloon is to fill the esophageal lumen and align the medical catheter 1 with the central axis of the esophagus in the region of the balloon, so that the radiation dose is evenly supplied to the esophageal wall. In the case of uterine cancer, the function of the balloon is to fill the uterine cavity and align the medical catheter 1 with the center of the uterine cavity in the region of the balloon, so that the radiation dose is evenly supplied to the uterine wall. In the case of breast cancer, the function of the balloon is to fill the tumor excision cavity of the breast tissue and align the medical catheter 1 with the center of the excision cavity made in the region of the balloon, so that the radiation dose is around the breast tissue. Evenly supplied to the wall. In use, the balloon is held in its expanded state (FIGS. 7 and 8) for a time sufficient to allow the radiation dose to affect cells that will continue to proliferate if left untreated. . Preferably, a sufficient radiation dose can be irradiated for about 1 minute to about 60 minutes to treat the cancer. The balloon, in its expanded state, strikes or at least proximate the esophageal wall, thereby centering the radiation source. This centering of the radiation source is important to ensure that all parts of the tissue or blood vessel receive the radiation as uniformly and as uniformly as possible. Centering also helps to prevent radiation burns or hot spots from occurring in portions of the target area.

  The uninflated balloons 4, 4 'may be provided as a plurality of radially and axially extending "wings" circumferentially spaced from each other around a longitudinal central axis of the balloon. The wing can be rolled or folded laterally in any desired manner. An elastic sleeve may be placed around the folded balloon. The balloons 4, 4 'are configured to expand in an essentially radial direction to the extent that they contact the inner wall of the esophagus. The balloons 4, 4 'can be configured to refold with a relatively small cross-section after inflating and deflating. This feature facilitates removal of the deflated catheter from the patient.

  According to one aspect of the invention, the outer diameter of the uninflated balloon 4, 4 'is 3mm, 4mm, 5mm, 6mm, or a value between any two of the above values, preferably 3mm to 4mm. .

  According to one aspect of the present invention, the outer diameter of the inflated balloons 4, 4 ′ is 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, 20 mm, 21 mm, 22 mm, 23 mm, 24 mm, 25 mm, 26 mm, 27 mm, 28 mm, 29 mm, 30 mm, 31 mm, 32 mm, 33 mm, 34 mm, 35 mm, 36 mm, 37 mm, 38 mm, 39 mm, 40 mm, 41 mm, 42 mm, 43 mm, 44 mm, 45 mm, 46 mm, 47 mm, 48 mm, 49 mm, 50 mm, or a value between any two of the above values, preferably 10 mm to 50 mm. For the treatment of esophageal cancer, the outer diameter of the inflated balloons 4, 4 'is preferably 10 mm to 35 mm. For the treatment of uterine cancer, the outer diameter of the inflated balloons 4, 4 'is preferably 15 mm to 35 mm. For the treatment of breast cancer, the outer diameter of the inflated balloons 4, 4 'is preferably 30 mm to 50 mm.

  The balloons 4, 4 'are made of an elastic material such as polyurethane, silicone, latex, poly (ethylene terephthalate) (PET), or polyamide. Conventional balloon materials used with dilatation catheters are suitable for use with catheters. Properties can be altered by changing the composition of the material.

  The balloons 4, 4 'can be attached to the elongate catheter tube 5 using any known technique in the art. For example, a commonly used technique is such that a short piece of tubing is used to bond a balloon onto the elongated catheter tube 5. One example is a heat-shrinkable tube material that joins a balloon onto an elongated catheter tube 5. Another technique is to melt the tube material on the elongated catheter tube 5, or to glue the tube material onto the elongated catheter tube 5, or to weld the tube material onto the elongated catheter tube 5. . The elongate catheter tube 5 is often prepared to receive any technique of attaching the tube material by roughening or modifying the joining surface of the elongate catheter tube 5 by sandblasting or laser engraving.

  The balloons 4, 4 'can be provided with radiopaque markers. Radiopaque markers may be provided at predetermined locations near the balloon (eg, adjacent to each axial end of the balloon) to facilitate positioning of the balloon at a desired location within the body.

  The removable inner tube 6 (FIG. 2) provides a dry lumen for receiving the source wire and guiding it to the treatment point in the catheter 1. The removable inner tube 6 is an elongated tube with a source wire lumen 22 extending therein that is sealed 10 at the distal end 8. The distal end 8 of the removable inner tube 6 has a rounded atraumatic tip, for example. The removable inner tube 6 has an opening 9 at the proximal end 7 that provides access to the lumen 22 by the source wire 19. Significantly, the source wire lumen 22 remains dry upon inflation of the balloon with inflation fluid by the seal 10 at the distal end 8.

  The removable inner tube 6 has an outer diameter that is small enough to be introduced into the inflation lumen 21, flexible enough to be maneuvered around the tortuous path of the nasopharyngeal path within the limits of the inflation lumen 21, and It has sufficient rigidity to give pushability. The removable inner tube 6 can be described as being non-kinkable or non-flexible. Non-kinking or non-flexible means that the wall of the tube 6 is damaged whenever the removable inner tube 6 is kinked. As described above, when the tube is folded to cause collapse of the tubular wall, a kink is formed, producing a fold known as a kink. Damage caused by kinks results in one or more traces of stress. Further, the source wire lumen 22 is restricted after kink, thereby preventing proper insertion of the source wire 19. Afterloading machines that advance the source 19 through the source wire lumen 22 are sensitive to resistance within the catheter. If the afterloading device detects resistance after kinking the tube, the source will be obstructed and automatically removed. Therefore, kinking of the removable inner tube 6 should be avoided. The non-kinkable nature of the removable inner tube 6 provides a degree of rigidity and pushability, which prevents the removable inner tube 6 from being deformed by advancement of the source 19. Also provides sufficient strength. Deformable properties, such as those found in kinkable or flexible tubes, are inappropriate for removable inner tubes because the insertion of the source can cause changes in the tube position. The source position should always be established in order to achieve an accurate dosimetry of treatment. The removable inner tube 6 is made from a material commonly used in catheter tube material that provides the above properties. As mentioned above, the terms “kinkable” and “non-kinkable” are known in the art.

  According to one aspect of the present invention, the bending stiffness in grams of the removable inner tube 6 is higher than the bending stiffness of the catheter tube 5. The bending rigidity of the removable inner tube 6 is 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11 than the bending rigidity of the catheter tube 5. %, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 60%, It may be 70%, 80% or more, or higher than the value between any two of the above values. Preferably, the bending stiffness in grams of the removable inner tube 6 is 1% to 60% higher than the bending stiffness of the catheter tube 5.

As described above, the removable inner tube 6 has the pushability necessary to advance through the subject entry point to the treatment site. According to one aspect of the present invention, the pushability of the removable inner tube 6 is higher than the pushability of the catheter tube 5. Pushability refers to the ability to transmit force from the proximal end to the distal end of the tube. More specifically, this is the response of the tube when a longitudinal force is applied along its axis. For small deflections, the tube material properties are given by equation (1): k _long = EA / L (1)
It is considered that the longitudinal stiffness of the spring is approximated to a spring system, where k _long is the longitudinal spring constant, E is the elastic modulus, A is the cross-sectional area, and L is the length of the tube. To maximize pushability, one skilled in the art maximizes the value of k _long . It will be appreciated that when maximizing tube pushability, the tube cross-sectional area is maximized, a rigid material that still provides the required flexibility is used to maximize the modulus of elasticity and reduce the overall length of the tube. Let's go. In the case of the removed inner tube 6 that requires good pushability characteristics, it is an important characteristic that the kink tendency is low because the kink causes irreparable damage to the tube wall. In the case of an elongated tube 5 where a high degree of pushability is not desirable, a high kink tendency is acceptable.

  According to another aspect of the present invention, the removable inner tube 6 has little or no shape recovery (due to its very thin wall thickness), so mechanical forces (e.g. tension, Even if the force is removed after it is deformed by applying a compressive force, it does not return to its previous shape. This allows the catheter tube 5 to be bent and kinked without damage, and more specifically, to allow the passage of the removable inner tube 6 while maintaining the integrity of the lumen 21. It differs from the catheter tube 5 which has sex. Due to the low shape recovery, bending the removable inner tube 6 to form a fold kink will permanently damage the source wire lumen 22 and prevent or free passage of the source wire 19. to disturb.

  The removable inner tube 6 is made of any suitable material that provides the desired properties (non-kinked tube, good pushability) with sufficient rigidity and strength and is biocompatible. Suitable materials are known in the art, such as polyimide, PEEK, or polyethylene. The removable inner tube 6 may be coated with a layer of PTFE or Teflon to provide lubricity. Alternatively, the tip of the removable inner tube 6 may be covered with oil. Lubricity helps to insert and withdraw from the inflation lumen 21 over the entire length of the catheter, which can be up to 1 m in length.

  The proximal end of the removable inner tube 6 can be connected to an adapter that can be coupled to a fitting on the radiation afterloading device that supplies the radioactive source wire 19.

  The diameter of the source wire lumen 22 of the removable inner tube 6 is sufficiently greater than the diameter of the source wire 19 so that the source wire 19 can be easily advanced and removed from the source wire lumen 22. Should be bigger. Generally, the diameter of the source wire lumen 22 is 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11 than the diameter of the radioactive source wire 19. %, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 25%, 30%, 35%, 40%, 45%, or 50% greater.

  According to one aspect of the present invention, the diameter of the source wire lumen 22 is 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1.0 mm, 1.2 mm, 1.4 mm, 1.6 mm, 1.8 mm, 1.9 mm, or 2.0 mm, or a value between any two of the above values, preferably 0.5 mm to 1.9 mm, more preferably 0.5 mm to 1.2 mm.

  According to one aspect of the present invention, the removable inner tube 6 walls are 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm. 0.9 mm, 1.0 mm, or a value between any two of the above values, preferably a thickness of 0.1 mm to 0.4 mm.

  According to one aspect of the present invention, the removable inner tube 6 comprises a visible scale that is marked along at least a portion of the length of the removable inner tube 6 wall. The scale may allow the user to specify the length of the removable inner tube 6 required for insertion so that the distal end 8 matches the area to be treated. The scale is inserted at a predetermined depth, for example, by allowing subsequent removable inner tubes 6 to be inserted and properly aligned during split therapy, thereby allowing the body scanner to be properly aligned during subsequent insertions. Eliminate the need. According to one aspect of the invention, the scale is on the half of the proximal side 7 of the removable inner tube 6. According to another aspect of the invention, the scale is marked in centimeters using a regular numeric display.

  According to one aspect of the invention, the removable inner tube 6 is reinforced at or towards the proximal end 7 to prevent or reduce deformation by applying circumferential pressure, such circumferential direction. The pressure can be applied by an expansion joint described below. The removable inner tube 6 can be reinforced by increasing the wall thickness at or towards the proximal end, for example by the use of a Nitinol or PEEK outer tube. This embodiment is illustrated in FIG. 13, where a Nitinol or PEEK tube 48 is mounted in a coaxial arrangement outside the removable inner tube 6. Alternatively, the removable inner tube 6 can be reinforced by increasing the wall thickness at or towards the proximal end, for example by the use of an inner tube of Nitinol or PEEK. This embodiment is illustrated in FIG. 14, where a Nitinol or PEEK reinforcement tube 49 is inserted in a coaxial arrangement into the source wire lumen 22 of the removable inner tube 6. Alternatively, the removable inner tube 6 may be reinforced by an extension tube material joined to the proximal end of the removable inner tube 6 by gluing or welding, which is a braided tube material, Nitinol. Or it is made from the tube material which has the required compressive strength, such as PEEK tube material. Such extension pieces are commonly used in the art, and adapting the present invention to include such extension pieces is well within the ability of one skilled in the art. This embodiment is shown in FIG. 15, where a Nitinol or PEEK reinforcing tube 50 is attached to the proximal end of the removable inner tube 6. Reinforcement facilitates attachment to an expansion joint that seals using circumferential pressure on the wall of the removable inner tube 6 by preventing distortion of the removable inner tube 6. The length of the reinforcing component can be between 0.5 cm and 5 cm.

  In a variation of the embodiment shown in FIG. 13 in which a Nitinol or PEEK reinforcement tube 48 is mounted in a coaxial arrangement outside the removable inner tube 6, the reinforcement tube 48 is directed toward the proximal end of the reinforcement tube 48. Or an annular ridge 51 may be disposed at the proximal end (FIG. 16). Since the ridge 51 has a larger diameter than the proximal port 13 of the expansion joint 12 (see below), it cannot pass through the proximal port 13. Accordingly, the annular ridge 51 serves as a calibration stop indicating the depth at which the removable inner tube 6 should be inserted into the medical balloon catheter 1. According to one aspect of the present invention, the position of the reinforcing tube 48 where the annular ridge 51 is disposed can be adjusted along the length of the removable inner tube 6. According to another aspect of the present invention, the position of the reinforcing tube 48 where the annular ridge 51 is disposed is fixed relative to the length of the removable inner tube 6.

  According to one aspect of the present invention, the removable inner tube 6 is longer than the medical balloon catheter 1. By making the tube longer, the inner tube 6 can be protruded from the medical balloon catheter 1 when inserted into the inflation lumen 21, so that the proximal end of the medical balloon catheter 1 and the removable inner tube 6 are close to each other. The distal end can be coupled to the expansion joint 12, and the removable inner tube 6 can be coupled to the afterloader. According to one aspect of the present invention, the removable inner tube 6 is 3 cm, 4 cm, 5 cm, 6 cm, 7 cm, 8 cm, 9 cm, 10 cm, 11 cm, 15 cm, 20 cm, 25 cm, 30 cm, more than the medical balloon catheter 1. 35 cm, 40 cm, 45 cm, 50 cm, 55 cm, 60 cm, 65 cm, 70 cm, 75 cm, 80 cm, 85 cm, 90 cm long, preferably 5 cm-15 cm long for esophageal applications and 10 cm-80 cm long for breast and uterine applications.

  According to one aspect of the present invention, the kit can be applied to the inflation lumen 21 to provide rigidity to the medical catheter 1 upon insertion into a subject via, for example, a nasopharyngeal route, a cervical route, a skin puncture portion, or the like. It further comprises a pusher wire 11 (FIG. 3) configured to be inserted and removed. The pusher wire is configured to be inserted into the inflation lumen 21 to increase the pushability of the catheter tube 5 and to be removed from the inflation lumen 21 to restore the flexibility of the catheter tube 5. Pusher wires are known in the art and typically comprise an elongated rod that has a high degree of flexibility and pushability to allow it to be advanced along a desired path. The pusher wire 11 is usually formed from a spring coil having a hollow center. The pusher wire 11 is typically made from stainless steel, but may be made from nitinol or other biocompatible material.

  According to one aspect of the present invention, the kit includes an expansion joint 12 (FIGS. 6, 7) configured to couple the proximal end of the catheter tube 5 to the expansion pump 30 to allow the balloon 4 to expand. 8 and 9). This allows access to the proximal end 7 of the removable inner tube 6 when the removable inner tube 6 is inserted into the inflation lumen 21 during inflation.

  Typically, the expansion joint 12 (FIG. 6) includes a distal port 14 in which a distal seal 16 is disposed, a proximal port 13 in which a proximal seal 15 is disposed, and a pump joint 17, which are joints 12. Fluidly connected to the chamber 27. The pump coupling 17 is preferably operatively connected to the valve 18.

  The distal port 14 can receive the proximal end of the catheter tube 5 and form a seal against the body of the catheter tube 5. The proximal port 13, which is preferably narrower in diameter, can receive the removable inner tube 6 and form a seal against the body of the removable inner tube 6 on the distal side of the opening 9. The proximal port 13 may not be able to accept the wider diameter of the catheter tube 5. As a result, the proximal end of the catheter end is positioned within the chamber 27 and is in fluid communication with the pump fitting 17.

  When the proximal port 13 and the distal port 14 are occupied, a watertight connection is thus formed between the inflation lumen 21 of the catheter tube 5 and the pump coupling 17 for connection to the inflation pump 30 (FIG. 7). The pump coupling 17 can be a screw connection, a push-in connection, a luer connection, or other suitable coupling.

One embodiment of the present invention is an expansion joint 12,
A distal port 14 configured to receive the proximal end of the catheter tube 5 and form a seal against the body of the catheter tube 5;
A proximal port 13 configured to receive a removable inner tube 6 inserted into the catheter tube 5 and to form a seal against the body of the removable inner tube 6 distal to the opening 9;
A pump coupling 17 configured to connect to the expansion pump 30;
The ports 13, 14, and the pump fitting 17 are in fluid communication with the chamber 27 of the fitting 12 that receives the proximal end of the catheter tube 5.
This is an expansion joint 12.

Another embodiment of the present invention is an expansion joint 12 comprising:
A distal port 14 in which a distal seal 16 is disposed;
A proximal port 13 in which a proximal seal 15 is disposed;
A pump coupling 17 operatively connected to the valve;
These are fluidly connected to the chamber 27 of the fitting 12;
The distal port 14 is configured to receive the proximal end of the catheter tube 5 and form a seal against the body of the catheter tube 5;
The proximal port 13 is configured to receive the removable inner tube 6 and form a seal against the body of the removable inner tube 6 distal to the opening 9; Allowing the proximal end to pass through the fitting 12;
This is an expansion joint 12.

  Proximal seal 15 and distal seal 16 are preferably compressible annular rings, which can be reduced in inner diameter by applying a compressive force parallel to the central axis of the ring. This can be achieved, for example, by providing screw extensions 30, 31 for each port 13, 14 into which bolts 25, 26 can be engaged (FIG. 9). The bolt has a hollow shaft and head through which the catheter tube 1 or removable inner tube 6 can be passed. By tightening the bolts 25, 26, the respective seals 15, 16 are compressed and the ports 13, 14 are sealed against the walls of the removable inner tube 6 or catheter tube 1, respectively.

  The central axes of the proximal port 13 and the distal port 14 are preferably essentially coincident. This allows the proximal end of the inner tube 6 to pass through both ports and out of the expansion joint 12. In this way, the opening 9 proximal end 7 of the removable inner tube 6 extends from the expansion joint 12 and allows access to the source wire 19 for insertion. According to one aspect of the present invention, the expansion joint 12 is a Y-shaped joint.

  Thus, the expansion joint 12 forms a chamber 27 that is sealed by the outer surface of the proximal end 2 of the catheter tube 5 and the outer surface distal to the opening 9 of the removable inner tube 6, thereby providing the medical catheter 1. The expansion lumen 21 and the pump coupling 17 are fluidly connected. The pump coupling 17 may be provided with a valve (plug) 18 for maintaining the pressure in the expansion lumen 21 after the expansion pump 30 is disconnected (FIG. 8). Thus, inflation of the balloons 4, 4 'is maintained when the valve is closed.

  Typically, the user inserts the tube 5 containing the pusher wire into the patient via the nasopharyngeal route, removes the pusher wire, installs the expansion joint 12 and connects the proximal end 2 of the catheter tube 5 to the distal port. 14, the removable inner tube 6 is inserted, and the proximal end of the removable inner tube 6 is connected to the proximal port 13.

  According to one aspect of the present invention, the kit further comprises an expansion pump 30. Such pumps are capable of providing inflation fluid pressure to the medical catheter 1 to gradually inflate and deflate the balloon and are known in the art. In general, the expansion pump is a syringe-type mechanism that allows the practitioner to fine-tune the distance traveled by the plunger element and that the pressure exerted by the fluid can be monitored by a pressure gauge. An embodiment of an expansion pump 30 according to the present invention is shown in FIG. 7 and connected to the expansion joint 12 via a tube material 31. The pump 30 includes a plunger 32 that can move linearly within the housing 34 to change the volume of the watertight chamber 35 at the distal end. The chamber exits outlet port 36 and is fluidly coupled to pressure gauge 37. The outlet port 36 is connected to the expansion joint 12 (pump joint 17) by the tube material 31. The plunger 32 is actuated by a handle 33. For fine control, the handle 33 can be adjusted 38, and the threaded shaft 39 of the plunger 32 will advance or retract linearly according to the direction in which the handle 33 is rotated. For coarse adjustment, the plunger 33 can be directly advanced or retracted by pushing and pulling the handle 33. The rotation or push / adjust mode of operation can be selected by a button 40 on the side of the housing that controls the engagement of the screw with the housing 34. Such devices are known in the art and are manufactured, for example, by Boston Scientific.

Another embodiment of the invention is a method of administering brachytherapy to a subject comprising:
The insertion of a medical balloon catheter 1 through an entry point (for example via a skin puncture or incision, nose, vagina, mouth, anus) in the subject, the medical balloon catheter 1 being a proximal end 2 And an elongated catheter tube 5 having a distal end 3 with an inflation lumen 20 extending therein, and at least one inflatable in fluid communication with the inflation lumen 21 of the catheter tube 5 toward the distal end 3 A medical balloon catheter 1 comprising a balloon 4, 4 ′, wherein the inflation lumen 21 is configured to carry inflation fluid to at least one inflatable balloon 4, 4 ′ in the presence of a removable inner tube 6. Inserting,
Positioning at least one inflatable balloon 4, 4 ′ in the treatment area;
Inserting the removable inner tube 6 into the inflation lumen 21 (FIG. 5), the removable inner tube 6 having an elongated body, an opening 9 proximal end 7, a closure 10 distal end 8, and Having a source wire lumen 22 extending therein;
The removable inner tube 6 is configured to be inserted and removed from at least a portion of the length of the inflation lumen 21;
The source wire lumen 22 is configured to house a source wire 19 carrying a therapeutic radiation source 20;
Inserting a removable inner tube 6,
Inflating at least one inflatable balloon 4, 4 ′ (FIG. 7);
Advance the radiation source wire 19 through the source wire lumen 22 to the treatment area and administer a constant radiation dose (FIG. 8);
-Removing the radiation source wire 19;
-Deflating at least one inflatable balloon 4, 4 ';
-Removing the removable inner tube 6; and optionally leaving the medical balloon catheter 1 in place for subsequent treatment sessions;
A method of administering brachytherapy to a subject.

  In order to give temporary rigidity to the medical balloon catheter 1, the pusher wire 11 (FIG. 3) is inserted into the inflation lumen 21 (FIG. 4) of the elongated catheter tube 5 before being advanced in the body. After positioning the medical balloon catheter 1, the pusher wire 11 is removed.

  Once the medical balloon catheter 1 is fitted, the proximal end 2 can be taped to the skin near the entry point. The flexibility of the elongated catheter tube 5 allows the catheter to be manipulated and bent over a wide range without significantly changing the position of the balloon in the body.

  The region from which the medical balloon catheter 1 exits can be fixed to the patient's skin with a bandage. This fixation ensures that the treated part is in the same place with respect to the tumor area by ensuring the catheter 1 in a fixed position between treatments.

  The method is preferably carried out using a kit as defined above. The medical balloon catheter 1 may include a scale that facilitates subsequent tube insertion for esophageal or intrauterine treatment or the like. For example, a new medical balloon catheter 1 can be inserted weekly and left in place from Monday to Friday and removed on the weekend. Each new tube is inserted on Monday using a scale to determine the exact insertion depth into the esophagus or uterine cavity. Treatment may last for several weeks in split therapy. The scale allows the medical balloon catheter 1 to be inserted into the correct position each time without the need for a visualization device such as an X-ray or CT scanner.

  After insertion of the medical balloon catheter 1, an expansion joint 12 as described above can be coupled to the proximal end 2 of the catheter 1, in particular to the catheter tube material 5.

  Immediately before treatment, the removable inner tube 6 is advanced along the inflation lumen 21 (FIG. 5). This is preferably advanced until it reaches the distal tip of the inflation lumen 21 (FIG. 5). Advantageously, the removable inner tube 6 may protrude 5 cm to 15 cm from the proximal end of the catheter tube 1 so that the proximal end of the medical balloon catheter 1 and the proximal end of the removable inner tube 6 are connected to an expansion joint. The removable inner tube 6 can be coupled to the afterloader. The outer surface of the removable inner tube 6 can be lubricated with, for example, silicone, a Teflon layer, or oil to aid in insertion. In order to ensure that a sufficient length has been inserted into the medical balloon catheter 1, the removable inner tube 6 can be graduated. The region distal to the opening 9 of the removable tube 6 can be reinforced to ensure a watertight connection with the expansion joint 12 without damaging the wall of the removable tube 6. At the level of reinforcement of the removable inner tube 6, the proximal annular ridge 51 of the reinforcing tube can ensure that the removable inner tube 6 is always inserted at the same depth.

  After insertion of the removable inner tube 6, the expansion joint 12 as described above can be coupled to the outer wall of the removable inner tube 6 on the distal side of the opening 9. The ports 13, 14 of the expansion joint 12 form a watertight chamber 27 so that the expansion lumen 21 can receive pressurized expansion fluid entering the chamber 27. The expansion joint 12 also allows access to the afterloading device by allowing access to the open proximal end of the inner tube 6. The expansion joint is attached to the expansion pump 30. Once expanded, the expansion joint 12 can be sealed by the valve 18 and the pump can be removed.

  One or more balloons are typically inflated using a saline solution as the inflation fluid. The saline may be mixed with 0.5% to 20% of a contrast agent such as Omnipark so that the balloon can be seen on radiographs or CT slices.

  The radiation source is delivered using a thin wire 19 provided with a radiation emitting material 20 at the distal end, which is passed through a source wire lumen 22. Using a device known as an afterloader or afterloading device, the source wire is supplied in a retractable and controllable manner. The proximal end 7 of the inner tube 6 may be provided with an adapter that allows connection to the output end of the afterloader.

  After the treatment, the source wire 19 is removed, the balloons 4, 4 'are deflated, the expansion joint 12 is removed, and the inner tube 6 is removed. The catheter 1 can remain in place comfortably and separately for subsequent treatment.

  The same catheter 1 can remain in place for long periods of time, for example up to 1 week, 2 weeks, or 3 weeks, without any discomfort or inflammation being reported. According to one aspect of the invention, subsequent treatments are repeated using the same catheter 1 worn for 3 days, 5 days, 6 days, 7 days, 10 days, 2 weeks, or 3 weeks. Preferably, the same catheter is worn for 5 days.

  According to one aspect of the present invention, during treatment, every 2 days, every 3 days, every 4 days, every 5 days, every 6 days, every 7 days, every 8 days, every 9 days, every 10 days, every 11 days, every 12 days, every 13 days, New catheters 1 are inserted at regular intervals that can be every day, every 15 days, every 16 days, every 17 days, every 18 days, every 19 days, every 20 days, or every 21 days, preferably every 7 days.

  According to one aspect of the invention, radiation is administered during treatment at regular intervals that can be every day, every two days, every three days, preferably every day. There may be an interruption in administration, for example on weekends or holidays.

Another embodiment of the invention is a method of administering radiation therapy to the esophagus, comprising:
Inserting the medical balloon catheter 1 into the patient's esophagus via the nasopharyngeal route, the medical balloon catheter 1 having a proximal end 2 and a distal end 3, and an inflation lumen 20 An elongated catheter tube 5 extending inward and at least one inflatable balloon 4, 4 ′ in fluid communication with the inflation lumen 21 of the catheter tube 5 toward the distal end 3, the inflation lumen 21 comprises: Inserting a medical balloon catheter 1 configured to carry inflation fluid to at least one inflatable balloon 4, 4 ′ in the presence of a removable inner tube 6;
Positioning at least one inflatable balloon 4, 4 ′ in the treatment area;
Inserting the removable inner tube 6 into the inflation lumen 21 (FIG. 5), the removable inner tube 6 having an elongated body, an opening 9 proximal end 7, a closure 10 distal end 8, and Having a source wire lumen 22 extending therein;
The removable inner tube 6 is configured to be inserted and removed from at least a portion of the length of the inflation lumen 21;
The source wire lumen 22 is configured to house a source wire 19 carrying a therapeutic radiation source 20;
Inserting a removable inner tube 6,
Inflating at least one inflatable balloon 4, 4 ′ (FIG. 7);
Advance the radiation source wire 19 through the source wire lumen 22 to the treatment area and administer a constant radiation dose (FIG. 8);
-Removing the radiation source wire 19;
-Deflating at least one inflatable balloon 4, 4 ';
-Removing the removable inner tube 6; and optionally leaving the medical balloon catheter 1 in place for subsequent treatment sessions;
Including radiation therapy to the esophagus.

  The insertion of the medical balloon catheter 1 can be performed using the same technique used by non-professionals to insert a feeding tube into the subject's stomach after oral or throat surgery. The medical balloon catheter 1 is inserted into the esophagus via the nasopharyngeal route, ie through the nose. The insertion is preferably performed by a nurse, but may be performed by a specialist as well. In order to provide temporary stiffness to the medical balloon catheter 1, the pusher wire 11 (FIG. 3) is inserted into the inflation lumen 21 (FIG. 4) of the elongated catheter tube 5 before being advanced through the nasopharyngeal passage. After positioning the medical balloon catheter 1, the pusher wire 11 is removed.

  Once the medical balloon catheter 1 is fitted, the proximal end 2 can be taped, eg, behind the subject's ear, for separate mounting until treatment. The flexibility of the elongated catheter tube 5 allows the catheter to be manipulated and bent over a wide range without significantly changing the position of the balloon in the esophagus.

  The area from which the medical balloon catheter 1 exits the nostril can be fixed with a bandage to the patient's nose. This fixation ensures that the treated part is in the same place with respect to the tumor area by ensuring the catheter 1 in a fixed position between treatments. The medical balloon catheter 1 is usually fixed to the nose between treatment sessions after insertion through the nasopharyngeal route.

  The method is preferably carried out using a kit as defined above. The medical balloon catheter 1 may include a scale that facilitates subsequent tube insertion. For example, a new medical balloon catheter 1 can be inserted weekly and left in place from Monday to Friday and removed on the weekend. Each new tube is inserted on Monday using a scale to determine the exact insertion depth into the esophagus. Treatment may last for several weeks in split therapy. The scale allows the medical balloon catheter 1 to be inserted into the correct position each time without the need for a visualization device such as an X-ray or CT scanner.

  After insertion of the medical balloon catheter 1, an expansion joint 12 as described above can be coupled to the proximal end 2 of the catheter 1, in particular to the catheter tube material 5.

  Immediately before treatment, the removable inner tube 6 is advanced along the inflation lumen 21 (FIG. 5). This is preferably advanced until it reaches the distal tip of the inflation lumen 21 (FIG. 5). Advantageously, the removable inner tube 6 may protrude 5 cm to 15 cm from the proximal end of the catheter tube 1 so that the proximal end of the medical balloon catheter 1 and the proximal end of the removable inner tube 6 are connected to an expansion joint. The removable inner tube 6 can be coupled to the afterloader. The outer surface of the removable inner tube 6 can be lubricated with, for example, silicone, a Teflon layer, or oil to aid in insertion. In order to ensure that a sufficient length has been inserted into the medical balloon catheter 1, the removable inner tube 6 can be graduated. The region distal to the opening 9 of the removable inner tube 6 can be reinforced to ensure a watertight connection with the expansion joint 12 without damaging the wall of the removable tube 6. At the level of reinforcement of the removable inner tube 6, the proximal annular ridge 51 of the reinforcing tube can ensure that the removable inner tube 6 is always inserted at the same depth.

  After insertion of the removable inner tube 6, the expansion joint 12 as described above can be coupled to the body of the removable inner tube 6 on the distal side of the opening 9. The ports 13, 14 of the expansion joint 12 form a watertight chamber 27 so that the expansion lumen 21 can receive pressurized expansion fluid entering the chamber 27. The expansion joint 12 also allows access to the afterloader by allowing access to the open proximal end of the inner tube 6. The expansion joint is attached to the expansion pump 30. Once expanded, the expansion joint 12 can be sealed by the valve 18 and the pump can be removed.

  One or more balloons are typically inflated using a saline solution as the inflation fluid. The saline may be mixed with 0.5% to 20% of a contrast agent such as Omnipark so that the balloon can be seen on radiographs or CT slices.

  The radiation source is delivered using a thin wire 19 provided with a radiation emitting material 20 at the distal end, which is passed through a source wire lumen 22. Using a device known as an afterloader, the source wire is supplied in a retractable and controllable manner. The proximal end 7 of the inner tube 6 may be provided with an adapter that allows connection to the output end of the afterloader.

  After the treatment, the source wire 19 is removed, the balloons 4, 4 'are deflated, the expansion joint 12 is removed, and the inner tube 6 is removed. The catheter 1 can remain in place comfortably and separately for subsequent treatment.

  The same catheter 1 can remain in place for long periods of time, for example up to 1 week, 2 weeks, or 3 weeks, without any discomfort or inflammation being reported. According to one aspect of the invention, subsequent treatments are repeated using the same catheter 1 worn for 3 days, 5 days, 6 days, 7 days, 10 days, 2 weeks, or 3 weeks. Preferably, the same catheter is worn for 5 days.

  According to one aspect of the present invention, during treatment, every 2 days, every 3 days, every 4 days, every 5 days, every 6 days, every 7 days, every 8 days, every 9 days, every 10 days, every 11 days, every 12 days, every 13 days, New catheters 1 are inserted at regular intervals that can be every day, every 15 days, every 16 days, every 17 days, every 18 days, every 19 days, every 20 days, or every 21 days, preferably every 7 days.

  According to one aspect of the invention, radiation is administered during treatment at regular intervals that can be every day, every two days, every three days, preferably every day. There may be an interruption in administration, for example on weekends or holidays.

Another embodiment of the present invention is a method of applying radiation therapy to the inner wall of the uterus, comprising:
Inserting the medical balloon catheter 1 into the subject's uterus via the cervical route, the medical balloon catheter 1 having a proximal end 2 and a distal end 3, and an inflation lumen 20 An elongated catheter tube 5 extending inward and at least one inflatable balloon 4, 4 ′ in fluid communication with the inflation lumen 21 of the catheter tube 5 toward the distal end 3, the inflation lumen 21 comprises: Inserting a medical balloon catheter 1 configured to carry inflation fluid to at least one inflatable balloon 4, 4 ′ in the presence of a removable inner tube 6;
Positioning at least one inflatable balloon 4, 4 ′ in the treatment area;
Inserting the removable inner tube 6 into the inflation lumen 21 (FIG. 5), the removable inner tube 6 having an elongated body, an opening 9 proximal end 7, a closure 10 distal end 8, and Having a source wire lumen 22 extending therein;
The removable inner tube 6 is configured to be inserted and removed from at least a portion of the length of the inflation lumen 21;
The source wire lumen 22 is configured to house a source wire 19 carrying a therapeutic radiation source 20;
Inserting a removable inner tube 6,
Inflating at least one inflatable balloon 4, 4 ′ (FIG. 7);
Advance the radiation source wire 19 through the source wire lumen 22 to the treatment area and administer a constant radiation dose (FIG. 8);
-Removing the radiation source wire 19;
-Deflating at least one inflatable balloon 4, 4 ';
-Removing the removable inner tube 6; and optionally leaving the medical balloon catheter 1 in place for subsequent treatment sessions;
A radiation therapy to the inner wall of the uterus.

  The insertion of the medical balloon catheter 1 can be performed using the same technique that non-specialists use to insert a hysterometer into the uterine cavity. The medical balloon catheter 1 is inserted into the uterine cavity via the cervix, that is, through the vagina. The insertion is preferably performed by a radiation oncologist, but may also be performed by a gynecologist. In order to provide temporary stiffness to the medical balloon catheter 1, the pusher wire 11 (FIG. 3) is inserted into the inflation lumen 21 (FIG. 4) of the elongated catheter tube 5 before being advanced through the cervical pathway. After positioning the medical balloon catheter 1, the pusher wire 11 is removed.

  The catheter 5 can be fixed at the neck outlet to fix the maintenance of the catheter 1 in the uterine space.

  Once the medical balloon catheter 1 is fitted and the proximal end is secured to the perineum using a bandage, the proximal end 2 can be mounted without trauma until the time of treatment, e.g. Can be taped to the skin. The flexibility of the elongated catheter tube 5 allows the catheter to be manipulated and bent over a wide range without significantly changing the position of the balloon in the uterus.

  The region where the medical balloon catheter 1 exits the vagina can be fixed with a bandage to the skin of the patient's perineum. This fixation ensures that the treated part is in the same place with respect to the tumor area by ensuring the catheter 1 in a fixed position between treatments. The medical balloon catheter 1 is usually fixed to the skin between a treatment session and a subsequent treatment session after being inserted via the cervical route.

  The method is preferably carried out using a kit as defined above. The medical balloon catheter 1 may include a scale that facilitates subsequent tube insertion. For example, a new medical balloon catheter 1 can be inserted weekly and left in place from Monday to Friday and removed on the weekend. Each new tube is inserted on a Monday using a scale to determine the exact insertion depth into the uterine cavity. Treatment may last for several weeks in split therapy. The scale allows the medical balloon catheter 1 to be inserted into the correct position each time without the need for a visualization device such as an X-ray or CT scanner.

  After insertion of the medical balloon catheter 1, an expansion joint 12 as described above can be coupled to the proximal end 2 of the catheter 1, in particular to the catheter tube material 5.

  Immediately before treatment, the removable inner tube 6 is advanced along the inflation lumen 21 (FIG. 5). This is preferably advanced until it reaches the distal tip of the inflation lumen 21 (FIG. 5). Advantageously, the removable inner tube 6 can project from 10 cm to 80 cm from the proximal end of the catheter tube 1 so that the proximal end of the medical balloon catheter 1 and the proximal end of the removable inner tube 6 are connected to an expansion joint. The removable inner tube 6 can be coupled to the afterloader. The outer surface of the removable inner tube 6 can be lubricated with, for example, silicone, a Teflon layer, or oil to aid in insertion. In order to ensure that a sufficient length has been inserted into the medical balloon catheter 1, the removable inner tube 6 can be graduated. The region distal to the opening 9 of the removable tube 6 can be reinforced to ensure a watertight connection with the expansion joint 12 without damaging the wall of the removable tube 6. At the level of reinforcement of the removable inner tube 6, the proximal annular ridge 51 of the reinforcing tube can ensure that the removable inner tube 6 is always inserted at the same depth.

  After insertion of the removable inner tube 6, the expansion joint 12 as described above can be coupled to the body of the removable inner tube 6 on the distal side of the opening 9. The ports 13, 14 of the expansion joint 12 form a watertight chamber 27 so that the expansion lumen 21 can receive pressurized expansion fluid entering the chamber 27. The expansion joint 12 also allows access to the afterloader by allowing access to the open proximal end of the inner tube 6. The expansion joint is attached to the expansion pump 30. Once expanded, the expansion joint 12 can be sealed by the valve 18 and the pump can be removed.

  One or more balloons are typically inflated using a saline solution as the inflation fluid. The saline may be mixed with 0.5% to 20% of a contrast agent such as Omnipark 300 (Nycomed) so that the balloon can be seen on radiographs or CT slices.

  The radiation source is delivered using a thin wire 19 provided with a radiation emitting material 20 at the distal end, which is passed through a source wire lumen 22. Using a device known as an afterloader, the source wire is supplied in a retractable and controllable manner. The proximal end 7 of the inner tube 6 may be provided with an adapter that allows connection to the output end of the afterloader.

  After the treatment, the source wire 19 is removed, the balloons 4, 4 'are deflated, the expansion joint 12 is removed, and the inner tube 6 is removed. The catheter 1 can remain in place comfortably and separately for subsequent treatment.

  The same catheter 1 can remain in place for long periods of time, for example up to 1 week, 2 weeks, or 3 weeks, without any discomfort or inflammation being reported. According to one aspect of the invention, subsequent treatments are repeated using the same catheter 1 worn for 3 days, 5 days, 6 days, 7 days, 10 days, 2 weeks, or 3 weeks. Preferably, the same catheter is worn for 5 days.

  According to one aspect of the present invention, during treatment, every 2 days, every 3 days, every 4 days, every 5 days, every 6 days, every 7 days, every 8 days, every 9 days, every 10 days, every 11 days, every 12 days, every 13 days, New catheters 1 are inserted at regular intervals that can be every day, every 15 days, every 16 days, every 17 days, every 18 days, every 19 days, every 20 days, or every 21 days, preferably every 7 days.

  According to one aspect of the invention, radiation is administered during treatment at regular intervals that can be every day, every two days, every three days, preferably every day. There may be an interruption in administration, for example on weekends or holidays.

Another embodiment of the invention is a method of applying radiation therapy to a mastectomy cavity, comprising:
Inserting a medical balloon catheter 1 into a mastectomy cavity of a subject after removal of a breast tumor (breast-conserving surgery), the medical balloon catheter 1 having a proximal end 2 and a distal end 3 An elongated catheter tube 5 having an inflation lumen 20 extending therein and at least one inflatable balloon 4, 4 ′ in fluid communication with the inflation lumen 21 of the catheter tube 5 toward the distal end 3. Inserting a medical balloon catheter 1 configured to carry inflation fluid to at least one inflatable balloon 4, 4 ′ in the presence of a removable inner tube 6.
Positioning at least one inflatable balloon 4, 4 ′ in the treatment area;
Inserting the removable inner tube 6 into the inflation lumen 21 (FIG. 5), the removable inner tube 6 having an elongated body, an opening 9 proximal end 7, a closure 10 distal end 8, and Having a source wire lumen 22 extending therein;
The removable inner tube 6 is configured to be inserted and removed from at least a portion of the length of the inflation lumen 21;
The source wire lumen 22 is configured to house a source wire 19 carrying a therapeutic radiation source 20;
Inserting a removable inner tube 6,
Inflating at least one inflatable balloon 4, 4 ′ (FIG. 7);
Advance the radiation source wire 19 through the source wire lumen 22 to the treatment area and administer a constant radiation dose (FIG. 8);
-Removing the radiation source wire 19;
-Deflating at least one inflatable balloon 4, 4 ';
-Removing the removable inner tube 6; and optionally leaving the medical balloon catheter 1 in place for subsequent treatment sessions;
A radiation therapy to the mastectomy cavity.

  The method is preferably carried out using a kit as defined above. The insertion of the medical balloon catheter 1 may be performed during or after surgical tumor resection using ultrasound or another imaging technique to position the balloon within the tumor resection cavity after skin puncture with a trocard needle. Can be done later. The medical balloon catheter 1 is inserted through a surgical scar or through the skin. In order to give temporary rigidity to the medical balloon catheter 1, a pusher wire 11 (FIG. 3) or a mandrel is inserted into the inflation lumen 21 (FIG. 4) of the elongated catheter tube 5 before insertion. After positioning the medical balloon catheter 1, the pusher wire 11 is removed.

  Once the medical balloon catheter 1 is fitted and the proximal end is secured to the breast skin using a bandage, the subject is placed so that the proximal end 2 exiting the breast is worn without trauma until treatment. Can be taped to the breast. The flexibility of the elongated catheter tube 5 allows the catheter to be manipulated and bent over a wide range without significantly changing the position of the balloon within the breast cavity.

  The area from which the medical balloon catheter 1 exits the breast can be secured to the patient's skin with a bandage. This fixation ensures that the treated part is in the same place with respect to the tumor area by ensuring the catheter 1 in a fixed position between treatments. The medical balloon catheter 1 is usually fixed to the breast skin after insertion between the treatment sessions.

  After insertion of the medical balloon catheter 1, an expansion joint 12 as described above can be coupled to the proximal end 2 of the catheter 1, in particular to the catheter tube material 5.

  Immediately before treatment, the removable inner tube 6 is advanced along the inflation lumen 21 (FIG. 5). This is preferably advanced until it reaches the distal tip of the inflation lumen 21 (FIG. 5). Advantageously, the removable inner tube 6 can project from 10 cm to 80 cm from the proximal end of the catheter tube 1 so that the proximal end of the medical balloon catheter 1 and the proximal end of the removable inner tube 6 are connected to an expansion joint. The removable inner tube 6 can be coupled to the afterloader. The outer surface of the removable inner tube 6 can be lubricated with, for example, silicone, a Teflon layer, or oil to aid in insertion. In order to ensure that a sufficient length has been inserted into the medical balloon catheter 1, the removable inner tube 6 can be graduated. The region distal to the opening 9 of the removable tube 6 can be reinforced to ensure a watertight connection with the expansion joint 12 without damaging the wall of the removable tube 6. At the level of reinforcement of the removable inner tube 6, the proximal annular ridge 51 of the reinforcing tube can ensure that the removable inner tube 6 is always inserted at the same depth.

  After insertion of the removable inner tube 6, the expansion joint 12 as described above can be coupled to the body of the removable inner tube 6 on the distal side of the opening 9. The ports 13, 14 of the expansion joint 12 form a watertight chamber 27 so that the expansion lumen 21 can receive pressurized expansion fluid entering the chamber 27. The expansion joint 12 also allows access to the afterloader by allowing access to the open proximal end of the inner tube 6. The expansion joint is attached to the expansion pump 30. Once expanded, the expansion joint 12 can be sealed by the valve 18 and the pump can be removed.

  One or more balloons are typically inflated using a saline solution as the inflation fluid. The saline may be mixed with 0.5% to 20% of a contrast agent such as Omnipark so that the balloon can be seen on radiographs or CT slices.

  The radiation source is delivered using a thin wire 19 provided with a radiation emitting material 20 at the distal end, which is passed through a source wire lumen 22. Using a device known as an afterloader, the source wire is supplied in a retractable and controllable manner. The proximal end 7 of the inner tube 6 may be provided with an adapter that allows connection to the output end of the afterloader.

  After the treatment, the source wire 19 is removed, the balloons 4, 4 'are deflated, the expansion joint 12 is removed, and the inner tube 6 is removed. The catheter 1 can remain in place comfortably and separately for subsequent treatment.

  The same catheter 1 can remain in place for long periods of time, for example up to 1 week, 2 weeks, or 3 weeks, without any discomfort or inflammation being reported. According to one aspect of the invention, subsequent treatments are repeated using the same catheter 1 worn for 3 days, 5 days, 6 days, 7 days, 10 days, 2 weeks, or 3 weeks. Preferably, the same catheter is worn for 5 days.

  According to one aspect of the invention, radiation is administered during treatment at regular intervals that can be every day, every two days, every three days, preferably every day. There may be an interruption in administration, for example on weekends or holidays.

  As described herein, the kits and methods are intended to deliver an appropriate dose of radiation to a treatment area, such as the esophageal or uterine lumen, or the mastectomy cavity, and may be constant if necessary. Configured to deliver doses at intervals of Because the catheter 1 allows multiple treatments to be performed, a single high dose or a split and repeated low dose can be delivered.

  In the case of definitive treatment, typical radiation doses provided for the treatment of cancer cells are as low as about 2 Gray (Gy) to about 4 Gray divided doses prescribed around the esophagus as seen in CT slices. It is preferable that Preferably, divided doses of 2 Gy to 3 Gy provide dose levels suitable for definitive treatment and are effective and prevent complications such as esophageal stricture (late side effects). This treatment is prescribed as a boost after external radiation therapy (50 Gy) combined with chemotherapy (taxotere and cisplatin) and can add 10 Gy to 20 Gy brachytherapy in 1 to 2 weeks.

  In the case of a uterine tumor, a divided dose of 3 Gy to 6 Gy, once a week to 3 times a week, with a total dose of up to 50 Gy to 60 Gy is considered sufficient for radical treatment. If the patient receives a combination of external radiation therapy and brachytherapy, i.e., for example, combining 40 Gy of external radiation therapy with 3-4 times of 5 Gy-6 Gy of intrauterine brachytherapy, the total dose delivered It may be less.

  For breast cancer patients, prescribing 1 cm from the balloon surface and irradiating a total dose of 30 Gy five times in divided doses of 6 Gy may be sufficient for partial breast radiation therapy. For boost treatment, a 3 × 5 Gy dose combined with 40 Gy to 50 Gy external breast radiation therapy should correspond to the standard electron beam boost effect delivered by external radiation therapy.

  In esophageal cancer, only complete responders (relative to radiochemotherapy) have been shown to overcome esophageal cancer, so to improve the local effects of chemotherapy and radiation and to increase the number of complete responders Radiation therapy can also be prescribed as preoperative therapy.

  In the case of palliative treatment, a dose of 5 Gy can be prescribed to the outer surface of the esophagus (viewed in CT slices) once a week to 3 times a week for a total of 10 Gy to 30 Gy over a period of one week to several weeks. The same range of doses can be delivered in a relaxed situation to patients presenting with uterine cancer.

  Radiation irradiated to the esophageal wall with a length of 10 cm using a 1.3 cm balloon diameter should be in the range of about 2 Gy to 3 Gy, usually less than 30 seconds, 1.5 minutes, Minutes, 2 minutes, 2.5 minutes, 3 minutes, 3.5 minutes, 4 minutes, 4.5 minutes, or 5 minutes, or a period between any two of the above values, preferably from 2 minutes to 5 minutes Irradiated.

  The same duration range is standard for uterine and breast cancer treatments.

Different radiation sources are used, and it is envisioned that preferred radiation sources include iridium ¹⁹² when gamma rays are used and californium ²⁵² when neutron particles are used. Furthermore, it is envisioned that the radiation source may provide neutron particles or gamma rays to affect the target cell. The use of gamma or neutron emitting radiation sources is well known to treat and kill cancer cells.

  Other modifications can be made to the invention without departing from the spirit and scope of the invention. Specific dimensions, doses, times, and construction materials are provided as examples, and alternatives that do not depart from the invention are readily envisioned.

  The invention is illustrated by the following non-limiting examples.

1. Esophageal lumen brachytherapy A 65-year-old patient with inoperable esophageal cancer. The patient was unable to operate because of the high risk of anesthesy. The tumor (squamous cell carcinoma) was located in the lower third of the esophagus and was 8 cm long. The thickness of the esophageal wall was a maximum thickness of 1 cm in some areas as seen by CT slice.

  Palliative therapy was selected because the patient's general condition was poor. The patient initially received 3 Gy for 10 sessions and 30 Gy external radiation therapy.

  One week later, a radiation oncology nurse inserted a nasopharyngeal access catheter. The treatment section of the catheter with the deflated balloon was placed approximately in regard to the cancer area. A connector with two valve systems was tightly secured to the proximal end of the access catheter. A catheter for introducing the radioactive source was introduced into the access catheter. Prior to introduction of the source catheter, several drops of oil were dropped on a distal length of 5 cm to 10 cm at the distal portion of the source catheter.

  The inner catheter for introducing the radioactive source was pushed in the access catheter until it reached the tip of the access catheter (the source catheter hits the tip of the access catheter).

  The proximal and distal valves of the coupling system were tightened until the entire coupling system was watertight.

  A syringe with a manometer containing 2 cc of Omnipark 2 cc and 18 cc of saline was connected to the balloon system.

  A coronal view was created using a CT scanner. From this figure, it was confirmed with the peripheral platinum marker that the position of the deflated balloon could be adapted to the position of the tumor as seen in the CT scan slice. The position covered the tumor length (8 cm) and kept equal margins from both sides of the tumor with respect to the balloon length.

  When the position was determined satisfactorily, the balloon was inflated with 20 cc of saline / omnipark mixture, and the balloon inflated diameter was 14 mm. CT slices stitched over the entire length of the esophageal tumor were made.

  The outer surface of the tumor was drawn on the CT screen using a special brachytherapy program (for example, the Plato dosimetry program by Nucletron).

  During each brachytherapy session from once a week to twice a week, a dose of 5 Gy was applied. Two weeks later, a total dose of 20 Gy was irradiated in four portions. The patient felt excellent and was able to withstand treatment very easily. The inflation time of the balloon system was in the range of 8 minutes per treatment to irradiate 5 Gy. This was slightly too long. The patient became unwell after about 5 minutes in each treatment session. The patient complained of pain in the esophageal area. Radiation therapy was interrupted, the radiation source was removed, and the balloon was deflated in seconds. After a 10 minute interruption, the patient's mood was restored, the balloon was reinflated, and the radioactive source was automatically repositioned where it left off. Radiation therapy was given perfectly according to the dose prescription.

  Patients were then observed over several months to detect complications from brachytherapy. The patient is still in good health 3 months after the end of brachytherapy and is currently following prognosis. The tumor is small, there are no late side effects (stenosis), and the patient has a normal diet.

2. Uterine cavity brachytherapy A 90-year-old woman with endometrial cancer. This patient has had bleeding for two years regularly, and the judgment at this point is to observe whether this patient has many other medical conditions and poor medical condition and survives long enough to suffer from tumor progression Was to do.

  One day, a patient complained of severe vaginal bleeding. The hemogram showed a hemoglobin value of 7 gr. The patient was taken to the hospital with a strong sense of weakness.

  The surgeon refused to perform an intervention (hysterectomy or hysterectomy) due to poor general condition and high anesthetic risk.

  After discussion, it was proposed to perform hyperfractionation therapy using external radiation therapy and brachytherapy. The patient received 2 courses every other week of 6 Gy external radiation therapy (4-portal irradiation) encompassing the entire uterus as seen in simulated CT scan slices. Four 6 Gy brachytherapy sessions were also performed using a balloon catheter, prescribed on the perimeter of the uterus as seen in the simulated CT scan slice.

  The treatment was well tolerated. After 6 months, the patient still had no bleeding and no surgical intervention was required. The patient is following prognosis to date.

3. Breast brachytherapy A 70-year-old woman with 1 cm diameter ductal carcinoma in the lower external quadrant of the right breast was given a sentinel lymph node technique. An anapathological examination showed no lymph node involvement.

  Breast tumors were excised with a safety margin of at least 1 cm from all sides (fan segmentation). Pathological examination showed a grade 1 tumor and confirmed negative lymphatic infiltration.

  Using a trocar needle, catheter 1 was introduced into the excision cavity one week after intervention under ultrasound guidance.

  The inner catheter 6 was introduced, and the joint device was fixed around the proximal end of the catheter 1 and the proximal end of the catheter 6. The balloon was inflated to a diameter of 4 cm. A CT scan produced an image showing the proper position of the system and the adhesion between the balloon and the ablation cavity wall.

  A dose of 6 Gy was prescribed and irradiated at a distance of 1 cm from the surface of the balloon. The balloon was deflated and the joint device was removed. This treatment was performed every day for 5 consecutive days, and the prescription for the high-risk area around the excision cavity was 30 Gy. After 5 days, the catheter 1 was removed.

  The patient did not need any external radiation therapy, and five weeks of standard therapy (external radiation therapy) was omitted. The patient went to the hospital regularly for management. Two years later, no local recurrence was detected on CT slices.

Claims (28)

A kit for administering brachytherapy to a subject,
A medical balloon catheter (1) having a proximal end (2) and a distal end (3), an elongated catheter tube (5) having an inflation lumen (21) extending therein, and the distal end (3) with at least one inflatable balloon (4, 4 ') in fluid communication with the inflation lumen (21) of the catheter tube (5), the inflation lumen (21) being removable When the inner tube (6) is slidably retractable, the catheter tube (5) is constructed so that the kink is unwound and stretched, and the inflation lumen (21) is formed by the removable inner tube. (6) is accommodated, and the inner tube (6) is configured to accommodate the source wire (19) one after another, and the expansion lumen (21) is present in the presence of the removable inner tube (6). A medical balloon catheter (1) configured to carry inflation fluid to the at least one inflatable balloon (4, 4 ');
A removable inner tube (6) having an elongated body, an opening (9) proximal end (7), a closure (10) distal end (8), and a source wire lumen (22) extending therein; Because
The removable inner tube (6) is configured to be inserted and removed from at least part of the length of the inflation lumen (21);
The source wire lumen (22) is configured to house a source wire (19) carrying a therapeutic radiation source (20);
A removable inner tube (6);
A kit for administering brachytherapy to a subject.   The balloon (4) can be inflated and when the removable inner tube (6) is inserted into the inflation lumen (21) during inflation, the opening (9) of the removable inner tube (6). ) Further comprising an expansion joint (12) configured to couple the proximal end of the catheter tube (5) to an expansion pump to allow access to the proximal end (7). The kit according to 1. The expansion joint (12)
A distal port (14) in which a distal seal (16) is disposed;
A proximal port (13) in which a proximal seal (15) is disposed;
A pump coupling (17) operatively connected to the valve;
The ports (13, 14) and the pump coupling (17) are in fluid connection with the chamber (27) of the coupling (12);
The distal port (14) is configured to receive the proximal end of the catheter tube (5) and form a seal against the body of the catheter tube (5);
The proximal port (13) receives the removable inner tube (6) and forms a seal against the body of the removable inner tube (6) distal to the opening (9); The kit of claim 2, wherein the kit is configured to allow the proximal end of the removable inner tube (6) to pass through the fitting (12).   The kit according to any one of claims 1 to 3, wherein an outer diameter of the catheter tube (5) is 2 mm to 6 mm.   The kit according to any one of claims 1 to 4, wherein the catheter tube (5) has a bending stiffness that is lower than the bending stiffness of the removable inner tube (6).   The kit according to any one of claims 1 to 5, wherein the catheter tube (5) is made of polyurethane or a polyurethane-containing compound.   The kit according to any one of the preceding claims, wherein the diameter of the inflation lumen (21) is 5% to 20% greater than the outer diameter of the removable inner tube (6).   An inextensible cord is disposed between the proximal end (2) and the distal end (3) of the catheter tube (5) to prevent longitudinal extension of the medical catheter (1). The kit according to any one of claims 1 to 7.   9. Kit according to claim 8, wherein the cord is arranged in, outside or inside the wall of the catheter tube (5).   10. Kit according to any one of the preceding claims, wherein the proximal end of the catheter tube (5) is reinforced to reduce deformation by applying circumferential pressure. The reinforcement is
An outer tube arranged on the proximal end of the catheter tube (5);
An inner tube inserted into the proximal end of the catheter tube (5), or an extension to the proximal end of the catheter tube (5),
The kit according to claim 10, comprising:   12. Kit according to any one of the preceding claims, wherein the medical catheter (1) comprises a visible scale marked along at least part of the length of the catheter tube (5).   The kit according to any one of the preceding claims, wherein the wall of the removable inner tube (6) has a thickness of 0.1 mm to 0.4 mm.   14. Kit according to any one of the preceding claims, wherein the removable inner tube (6) has a higher bending stiffness than the catheter tube (5).   15. Kit according to any one of the preceding claims, wherein the proximal end of the removable inner tube (6) is reinforced to reduce deformation by applying circumferential pressure. The reinforcement is
-A reinforced outer tube (48) disposed on the removable inner tube (6) towards or towards the proximal end,
A reinforced inner tube (49) which is inserted into the removable inner tube (6) towards or towards the proximal end, or the proximal end of the removable inner tube (6) Reinforcement extension against (50),
The kit according to claim 15, comprising:   The reinforced outer tube (48) disposed on the removable inner tube (6) has an annular ridge (51) at or toward the proximal end of the reinforced tube (48). The kit according to claim 16, wherein the kit is arranged.   18. Kit according to any one of the preceding claims, wherein the removable inner tube (6) comprises a visible scale marked along at least part of its length.   19. Kit according to any one of the preceding claims, wherein the bending rigidity of the removable inner tube (6) is 1% to 60% higher than the bending rigidity of the catheter tube (5).   20. Kit according to any one of the preceding claims, wherein the removable inner tube (6) is made of polyimide, PEEK (polyetheretherketone) or polyethylene.   21. Kit according to any one of the preceding claims, wherein the diameter of the source wire lumen (22) of the removable inner tube (6) is between 0.5 mm and 1.9 mm.   The kit according to any one of the preceding claims, wherein the removable inner tube (6) is 3 to 90 cm longer than the medical balloon catheter (1).   A removable pusher wire (11) configured to be inserted and removed from the inflation lumen (21) to provide rigidity to the catheter tube (5) upon insertion into a subject via a nasopharyngeal route The kit according to any one of claims 1 to 22, further comprising:   24. Kit according to claim 23, wherein the pusher wire (11) has a higher bending stiffness than that of the removable inner tube (6).   The kit according to any one of the preceding claims, further comprising an expansion pump (30).   The kit according to any one of claims 1 to 25, wherein the medical balloon catheter is configured to be inserted into the esophagus via the nasopharyngeal route.   27. A kit according to any one of the preceding claims, wherein the medical balloon catheter is configured to be inserted into the uterine cavity via the cervical route.   The kit according to any one of claims 1 to 27, wherein the medical balloon catheter is configured to be inserted into breast tissue via a breast incision or needle puncture.